SYSTEM, DEVICES AND METHODS FOR COLLECTING BODY FLUID SAMPLES

专利摘要:
system, device and methods for collecting body fluid samples, the device comprises a first portion comprising at least one sample collection channel configured to draw sample fluid into the collection channel through a first driving force. the sample collection device includes a second portion containing a sample container for receiving and maintaining the fluid sample collected in the collection channel, the container operationally connected to be in fluid communication with the collection channel and, when the fluid is established, the container provides a second driving force, different from the first, to move most of the fluid sample from the channel to the container.
公开号:BR112015005028B1
申请号:R112015005028-0
申请日:2013-09-06
公开日:2020-12-15
发明作者:Elizabeth Holmes；Michael Chen；Pey-Jiun Ko；Tammy Burd；Adrit Lath；Patricia McHale
申请人:Theranos Ip Company, Llc；
IPC主号:

专利说明:

Background
[0001] A blood sample for use in laboratory tests is often obtained through venipuncture, which typically involves the insertion of a hypodermic needle into the patient's vein. Blood drawn from the hypodermic needle can be drawn directly into a syringe or into one or sealed vials for further processing. When a venipuncture may be difficult or impractical, as in a newborn, a non-venous puncture, such as a hole in the heel or another alternative puncture can be used to draw a blood sample for testing. After the blood sample is collected, the extracted sample is usually packaged and transferred to a processing center for analysis.
[0002] Unfortunately, sample collection and conventional technical analysis of body fluid samples have disadvantages. For example, except for the most basic tests, blood tests that are currently available typically require a substantially large volume of blood to be drawn from the patient. Due to the large volume of blood, the extraction of blood to samples from alternative sites in a patient, which can be less painful and / or less invasive, is often disadvantaged as they do not produce the blood volumes necessary for conventional assay methodologies. In some cases, patient apprehension associated with venipuncture can reduce patient compliance with the test protocol. In addition, the traditional collection technique adds unnecessary complexity when trying to separate a single blood sample into different containers for different pre-analytical processing. resume
[0003] At least some of the disadvantages associated with the prior art are overcome by at least some or all of the embodiments described in this disclosure. Although the embodiments here are typically described in the context of obtaining a blood sample, it should be understood that the embodiments of this invention are not limited to blood samples and can also be adapted to acquire another sample fluid (s) ( s) of the body for analysis.
[0004] In one embodiment described herein, a device is provided for collecting a sample of body fluid. This embodiment may be useful for accurately collecting small volumes of body fluid samples that are often associated with drawing non-venous blood. In a non-limiting example, the sample volume is about 1 ml or less. Optionally, the sample volume is about 900 µl or less. Optionally, the sample volume is about 800 µl or less. Optionally, the sample volume is about 700 µl or less. Optionally, the sample volume is about 600 µl or less. Optionally, the sample volume is about (500); 1 or less Optionally, the sample volume is about 400; 1 or less Optionally, the sample volume is about 300; 1 or less Optionally, the sample volume is about 200; 1 or less Optionally, the sample volume is about 100; 1 or less Optionally, the sample volume is about 90; 1 or less Optionally, the sample volume is about 80; 1 or less Optionally, the sample volume is about 70; 1 or less Optionally, the sample volume is about 60; 1 Optionally, the sample volume is about 50; 1 or less . or less
[0005] In a non-limiting example, this device can be used to divide the body fluid sample directly into two or more different portions which are then deposited in the respective containers. In a non-limiting example, the device comprises a first portion that has at least two sampling channels configured to extract the fluid sample into the sampling channels through a first type of driving force, wherein one of the channels Sample collection tube has an inner liner designed to mix with the fluid sample and the other of the sample collection channels has another inner liner chemically different from said first inner liner. The sample collection device includes a second portion comprising a plurality of sample containers for receiving the body fluid sample collected in the sample collection channels, the sample containers operationally connected in fluid communication with the collection channels, after which when fluid communication is established, the containers provide a second driving force different from the first driving force to move the majority of the body fluid sample from the channels to the containers. The containers can be arranged in such a way that mixing of the fluid sample between the containers does not occur. Since this device can be used with non-venous withdrawal, it may take a longer period of time to obtain a desired volume of sample and the initial introduction of a material, such as an anticoagulant that can line the channels, can prevent premature coagulation of the channels during collection.
[0006] In another embodiment described herein, a device is provided for collecting a sample of body fluid. The device comprises a first part comprising a plurality of sample collection channels, in which at least two of the channels are configured to simultaneously withdraw the fluid sample from each of the at least two sample collection channels through a first type of sample. driving force. The device may also include a second portion comprising a plurality of sample containers for receiving the sample of body fluid collected in the sample collection channels, where the sample containers have a first state in which the sample containers are not in contact. fluid communication with the sampling channels, and a second condition in which the sample containers are operatively linked to be in fluid communication with the sampling channels, after which, when fluid communication is established, the containers de provide a second driving force different from the first driving force for moving the body fluid sample from the channels to the containers.
[0007] In yet another embodiment described herein, a method is provided comprising measuring a minimum sample amount in at least two channels using a sample collection device with at least two sample collection channels configured to simultaneously withdraw the sample. fluid sample in each of the at least two sampling channels using a first type of driving force. After a desired amount of fluid sample has been confirmed in the sampling channels, fluid communication is established between the sampling channels and the sample containers, after which the containers provide a second driving force different from the first force motive used to move body fluid samples from channels to containers. In some alternative embodiments, devices that use a single channel to collect fluid or devices that have a plurality of channels, but do not collect them simultaneously from the body are not excluded. Optionally, the collection of the fluid sample is performed without the use of a material.
[0008] In one embodiment, there is a discrete amount of time between collecting the sample and introducing the sample into a sample pre-processing device. In a non-limiting example, the process is a non-continuous process. Sample collection takes place at a treatment station and then the sample is taken to a second station. This second station may be in the construction of the sample. Optionally, the second station can be located at another location where the sample must be carried, propelled, piloted, transported, placed in a transport device, or placed in a transport container to reach the second position. In this way, there is a slight processing pause to allow for the time associated with sample transport.
[0009] In another embodiment described herein, separator gel can also be included in the sample containers so that the gels will separate the cell-free fractions from the total blood from the solid or semi-solid portions or other cellular portions Sample. Such a gel or other similar separating material may be included in the sample container before, during, or after the sample is introduced into the sample container. The separation material can have an intermediate density between that of cells and solution components, so that the material separates the sample components flowing to a position between the solution layers and not the sample solution during separation, such as by centrifugation. After centrifugation, the separating material stops flowing and remains a smooth barrier between the layers. In some embodiments, the separation material can be further processed to harden and form a more rigid barrier. In the non-limiting example, the separation material may be a UV-curable material, such as, but not limited to, sorbitol-based thixotropic gelator gel in a diacrylate oligomer. The sample container can have the entire container or, optionally, the portion with the UV curable material exposed to UV light for a period of time such as, but not limited to, 10 to 30 seconds to harden the material. Such hardening may involve crosslinking the material contained in the UV curable material. Optionally, the UV curable material can be used in conjunction with traditional separating gel material so that only one side (the solution side or the solid side) is in contact with the UV cured material. Optionally, the UV curing material can be used with a third material such that the UV curing material is between two separation materials and is not in direct contact with the solution and non-solution portions of the sample.
[0010] This summary is provided to introduce a variety of concepts in a simplified way, which are further described below in the detailed description. This Summary is not intended to identify the main features or essential features of the claimed matter, nor is it intended to be used to limit the scope of the claimed matter. Incorporation by reference
[0011] All publications, patents and patent applications mentioned in this description are incorporated herein by reference, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated by reference. Brief description of the drawings
[0012] Figures 1A-1B show perspective views of a sample collection device according to an embodiment, as described herein.
[0013] Figures 2A-2C show perspective views of a sample collection device without a lid according to an embodiment, as described herein.
[0014] Figures 3A-3B show side and cross-sectional views of a sample collection device according to an embodiment, as described herein.
[0015] Figures 4A-4B show side and cross-sectional views of a sample collection device according to an embodiment, as described herein.
[0016] Figures 5A-5B show perspective views of a sample collection device according to another embodiment, as described herein.
[0017] Figures 6A-6B show side views of a sample collection device according to an embodiment as described here.
[0018] Figures 7A-8B show side and cross-sectional views of a sample collection device according to an embodiment, as described herein.
[0019] Figures 9A-9C show side and cross-sectional views of a sample collection device in various stages of use according to an embodiment, as described herein.
[0020] Figures 10A-10B show perspective views of a sample collection device according to an embodiment, as described herein.
[0021] Figures 11A-11R show various views of a sample collection device according to an embodiment, as described herein.
[0022] Figure 12 shows a schematic diagram of a portion of the tip of a sleeve and balancing forces associated with an embodiment, as described herein.
[0023] Figures 13-15 show several views of a collection device with a single collection site according to an embodiment, as described here.
[0024] Figures 16-17 show perspective and final views of a sample collection device using containers that have identifiers according to a modality as described here.
[0025] Figures 18A-18E show various views of sample containers according to embodiments as described here.
[0026] Figures 19A-19C show a view of various embodiments of a front end of a sample collection device.
[0027] Figures 20-21 show various ways of implementing the sample collection device with an integrated tissue penetration element.
[0028] Figures 22A-22C show schematic diagrams of various embodiments, as described herein.
[0029] Figure 23 shows a schematic view of an embodiment of the system described here. Description of specific embodiments
[0030] It is to be understood that both the previous general description and the following detailed description are only exemplary and explanatory and are not restrictive of the invention, as claimed. It may be noted that, as used in the description and the appended claims, the singular forms "one", "one", "o" and "a" include the respective plurals unless the context clearly dictates otherwise. Thus, for example, the reference to "a material" can include mixtures of materials, the reference to "a compound" can include several compounds, and the like. The references cited herein are incorporated by reference in their entirety, except to the extent that they conflict with the teachings explicitly set out in this description.
[0031] In the present description and in the claims that follow, reference will be made to a number of terms that will be defined as having the following meanings:
[0032] "Optional" or "optionally" means that the circumstances described subsequently may or may not occur, so the description includes cases in which the circumstance occurs and cases in which it does not. For example, if a device optionally contains a sample collection feature, it means that the sample collection feature may or may not be present, and so the description includes both structures, in which a device has the sample collection feature and structures where the sample collection feature is not present.
[0033] Referring now to Figures 1A-1B, one embodiment of a (100) sample collection device will now be described. In this non-limiting example, the sample collection device (100) can include a collection device body (120), the support (130) and the base (140). In some cases, a lid (110) can be optionally provided. In one embodiment, the lid can be used to protect the opening, keeping it clean, and to cover the bloody tip after collection. Optionally or alternatively, the cap can also be used to limit the flow rate during the transfer of sample fluid to the sample containers by controlling the amount of ventilation provided to the capillaries. Some configurations may include ventilation paths (permanently open or operationally lockable) in the lid, while others may not. Optionally, the collection device body (120) can include a first portion of the device (100) that has one or more collection routes, such as, but not limited to, collection channels (122a, 122b) inside, who may be able to receive sample B. Figure 1A shows that sample B only partially fills the channels (122a, 122b), but it should be understood that, although partial fills are not excluded in some alternative embodiments, in most of the examples of implementation the channels will be completely filled with sample B, when the filling process is completed. In this embodiment, the base (140) may have one or more fill indicators (142a, 142b), such as, but not limited to, optical indicators, which can provide an indication of the fact that the sample has reached one or more containers housed in the base. It should be understood that, although this indication may be by visual indication, other methods, such as audio, vibration, or other indication methods, may be used in place of, or in combination with, the recommendation. The indicators can be in at least one of the containers. There may be variations and alternatives to the embodiments described herein and a single embodiment should not be interpreted in a way that covers the entire invention.
[0034] Although not shown for ease of illustration, the support (130) can also include one or more fill indicators that show whether a desired fill level has been achieved in channels (122a and 122b). These can be arranged in place of or in addition to the indicators (142a, 142b). It is clear that one or more track filling indicators can be positioned on a different part and are not limited to the support (130). It should be understood that, although this indication of the level of filling in one or more of the channels (122a and 122b) can be by means of a visual indication, other methods of indication, such as audio, vibration, or others can be used in place of or in combination with the indication method. The indicator may be on at least one of the collection routes. Optionally, the indicators are in all collection routes.
[0035] In the present embodiment, the support (130) can be used to join the body (120) and the base (140) to form an integrated device. It should be understood that, although the device body (120), the support (130), and the base (140) are recited as separate parts, one or more of said parts can be integrally formed to simplify manufacture and such integration does not is excluded here.
[0036] In some embodiments of this invention, a lid (110) can optionally be provided. In a non-limiting example, the cap can be placed on a part of the body of the collection device (120). The cover (110) can be detachable from the body of the collection device (120). In some cases, the lid (110) may be completely separable from the collection device body (120), or may retain a portion that is attached to the collection device body, such as, but not limited to, being hinged or otherwise linked to the collection device. The cover (110) can cover a part of the body of the collection device (120) containing exposed ends of one or more channels in it. The cap (110) can prevent material, such as air, fluid, or particles, from entering the channels within the body of the device, when the cap is in place. Optionally, the cover (110) can connect to the collection body (120), using any technique known or later developed in the art. For example, the cover can be snap-on, twist, friction-fit, handle, have magnetic portions, connect, use elastic portions, and / or can connect removably to the body of the collection device. The lid can form a fluid-tight seal with the collection device body. The lid can be formed from an opaque, transparent or translucent material.
[0037] In one embodiment, a sampling device body (120) of a sampling device may contain at least a portion of one or more sampling routes, such as, but not limited to, the channels ( 122a, 122b) therein. It must be understood that collection channels that are not channels are not excluded. The body of the collection device can be connected to a support (130) which can contain a portion of one or more channels in it. The body of the collection device can be permanently attached to the support or it can be removable in relation to the support. In some cases, the collection device body and the support can be formed of a single integral part. Alternatively, the body of the collection device and the support can be formed from separate parts. During the operation of the device, the collection device and the holder do not move in relation to each other.
[0038] Optionally, the collection device body (120) can be formed in whole or in part from an optically transmissive material. For example, the body of the collection device can be formed from a transparent or translucent material. Optionally, only selected portions of the body are transparent or translucent to view the fluid collection channel (s). Optionally, the body comprises an opaque material, but an opening and / or a window can be formed in the body to show the filling levels therein. The body of the collection device may allow a user to view the channels (122a, 122b) within and / or passing through the body of the device. The channels can be formed of a transparent or translucent material that can allow a user to check whether sample B has traveled through the channels. The channels can be substantially the same length. In some cases, a support (130) can be formed of an opaque material, a transparent material, or a translucent material. The holder may or may not have the same optical characteristics as the collection device body. The support can be formed from a material other than the body of the collection device, or from the same material as the body of the collection device.
[0039] The collection device body (120) can be of any shape or size. In some instances, the collection device body may have a circular, elliptical, triangular, quadrangular shape (for example, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other shape in cross section. The shape of the cross section may remain the same or may vary over the length of the collection device body. In some cases, the collection device body may have a cross-sectional area less than or equal to about 10 cm2, 7 cm2, 5 cm2, 4 cm2, 3 cm2, 2.5 cm2, 2 cm2, 1.5 cm2, 1 cm2, 0.8 cm2, 0.5 cm2, 0.3 cm2, or 0.12 cm. The cross-sectional area may vary or may remain the same along the length of the collection device body (120). The body of the collection device may be less than or equal to approximately 20 cm, 15 cm, 12 cm 10 cm, 9 cm, 8 cm, 7 cm to 6 cm, 5 cm, 4 cm, 3 cm , 2 centimeters, 1 cm, 0.5 cm, or 0.1 cm. The body of the collection device (120) can be longer or shorter than the cover, or the support base, or the same length as the cover, support, or base. There may be variations and alternatives to the embodiments described herein and the single embodiment should not be interpreted in a way that encompasses the entire invention.
[0040] In one embodiment, the collection routes, such as, but not limited to, the channels (122a, 122b) can also have a selected cross-sectional shape. Some embodiments may have channels with the same shape as the cross section along the entire length of the channel. Optionally, the shape of the cross section can remain the same or can vary along the length. For example, some embodiments may have a shape at one location and a different shape at one or more different locations along the length of the channel. Some embodiments may have a channel with a cross-sectional shape and at least another channel with a different cross-sectional shape. As a non-limiting example, some may have a circular, elliptical, triangular, quadrangular shape (for example, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other shape in cross section. The shape of the cross section can be the same for the body, support and base, or it can vary. Some embodiments may choose a way to maximize the volume of liquid that can be maintained in channels of a specific width and / or height. Some may have one of the channels (122a, 122b) with a cross-sectional shape, while another channel has a differently-shaped cross-section. In one embodiment, the shape of the channel cross section can help to maximize the volume inside it, but optionally, it can also improve the capillary forces that pull blood. This will allow for a maximized filling rate. It should be understood that, in some embodiments, the shape of the channel cross section can directly affect capillary forces. As a non-limiting example, a sample volume can be contained in a shallow and wide channel, or a rounded channel, both containing the same volume, but it may be desirable in place of each other for the filling speed, less chance of retention or factors related to channel performance.
[0041] Although the channels can have any shape or size, some embodiments are configured in such a way that the channel presents a capillary action when in contact with the fluid sample. In some cases, the channel may have a cross-sectional area less than or equal to about 10 mm2, 7 mm2, 5 mm2, 4 mm2, 3 mm2, 2.5 mm2, 2 mm2, 1.5 mm2, 1 mm2, 0.8 mm2, 0.5 mm2, 0.3 mm2, or 0.1 mm2. The size of the cross section may remain the same or may vary along the length. Some configurations can be customized for greater strength over a given length and then less at a different length. The shape of the cross section can remain the same or it can vary along the length. Some channels have a straight configuration. Some embodiments may have curves or other path shapes in isolation or in combination with the rectilinear portions. Some may have different orientations within the body of the device (120). For example, when the device is kept substantially horizontal, one or more channels can tilt down, tilt up, or tilt at all, as they transport fluid from the device's initial collection point.
[0042] The channels (122a, 122b) can be supported by the device body (120) and / or the support (130). In some cases, the entire length of the channels can be enclosed within the combination of the device body and the support. In some cases, a portion of the channels may be inside the body of the device and a portion of the channels may be inside the holder. The position of the channels can be affixed by the device body and / or the support. In some embodiments, the channels can be defined as lumens within a hollow needle. In some embodiments, the channels are defined only on three sides, with at least one side open. Optionally, a cover layer separate from the body can define the side that would otherwise be opened. Some embodiments may define different sides of the channel with different materials. These materials can be provided by the body or they can be provided by different parts of the collection device. Some embodiments may have all channels on the same plane. Optionally, some may have a shape that takes at least a portion of the channel to a different plane and / or orientation. Optionally, some channels can be entirely in a different plane and / or orientation.
[0043] In some cases, a plurality of channels may be provided. In some embodiments, a channel splits into two or more channels. Optionally, some channels can split into an even greater number of channels. Some channels may include a control mechanism, such as, but not limited to, a valve to direct the flow in the channel (s). At least part of the channels can be substantially parallel to another. Alternatively, none of the channels need to be parallel to each other. In some cases, at least parts of the channels are not parallel to each other. Optionally, the channels can be slightly folded. Optionally, channels can have a cross-sectional area in one position and a smaller cross-sectional area in a different location along the channel. Optionally, channels can have a cross-sectional area in one position and a larger cross-sectional area in a different location along the channel. For some embodiments of the Y configuration, it may be desirable for channels that have openings placed appropriately to define the sample for each vial, so that there would be no sample pulled or cross-contamination from other channels. As a non-limiting example, an embodiment with openings is shown in Figure 11I.
[0044] The base (140) can be provided inside the sample collection device. The base can be connected to the support (130). In some cases, a portion of the base may be inserted into the holder and / or a portion of the holder may be insertable into the base. The base may be able to move relative to the support. In some cases, a sample collection device may have a longitudinal axis that extends along the length of the sample collection device. The base and / or support can move relative to each other in the direction of the longitudinal axis. The base and / or support may be able to move a limited distance from each other. Alternatively, the base can be fixed in relation to the support. The base can be provided at one end of the sample collection device opposite the end of the sample collection device comprising a lid (110). Optionally, some embodiments can include an integrated base / container part so that there are no longer separate containers that are mounted on the base parts. There may be variations and alternatives to the embodiments described herein and a single embodiment should not be interpreted in a way that covers the entire invention.
[0045] A base (140) can accommodate one or more containers in it. The containers can be in fluid communication with the channels and / or can be put in fluid communication with the channels. An end of a channel can be inside the container or can be inserted into the container. The base may have one or more optical indicators (142a, 142b), which can provide a visual indication of whether the sample has reached one or more containers housed in the base. In some embodiments, optical indicators can be optical windows that can allow a user to see into the base. The optical window can be formed from a transparent and / or translucent material. Alternatively, the optical window can be an opening without any material in it. The optical window can allow a user to directly view a container inside the base. The container inside the base can be formed of a transparent and / or translucent material that can allow a user to see if a sample has reached the base container. For example, if blood is transported along the channel to the containers, the containers can visually indicate the presence of blood inside. In other embodiments, the optical indicators may include other characteristics that may indicate that the container has been filled. For example, one or more sensors can be provided inside the base or the container and can determine whether a sufficient amount of sample has been provided inside the container. The one or more sensors can provide a signal for an optical indicator on the base which can indicate whether the sample has been provided to the container and / or the amount of sample that has been provided to the container. For example, the optical indicator may include a display, such as, but not limited to, an LCD monitor, light display (eg, LED display), plasma screen display that can provide an indication that the containers have been sufficiently filled. In alternative embodiments, an optical indicator does not need to be provided, but alternative indicators can be provided, such as, but not limited to, an audible indicator or a temperature controlled indicator can be used to indicate when the containers have been filled.
[0046] Figures 2A-2C offer views of a sample collection device (200) without a cover (110). The sample collection device (200) can include a body (220), the support (230) and base (240). The body can be attached to the support. In the present embodiment, the base (240) can be connected to the support at an end opposite the end connected to the body. The body can support and / or contain at least a portion of one, two, or more channels (222a, 222b). The channels may be able to receive a sample (224a, 224b) from a sample receiving end (226) of the device.
[0047] The body (220) can have a hollow portion (225) inside it. Alternatively, the body can be formed from a solid part. The channels (222a, 222b) can be formed integrally in the body. For example, they can be passages that pass through a solid portion of the body. The passages may have been drilled through, or formed using lithographic techniques. Alternatively, the channels can be separate structures that can be supported by the body. For example, channels can be formed from one or more tubes that can be supported by the body. In some cases, the channels can be held in place in certain solid parts of the body and can pass through one or more portions of the hollow body. Optionally, the body (220) can be formed from two pieces joined to define the channels (222a) and (222b) inside it.
[0048] Channels (222a, 222b) may include one or more features mentioned elsewhere in this document. At least part of the channels can be substantially parallel to each other. Alternatively, the channels can be at angles to each other. In some embodiments, the channels may have a first end which may be at a sample receiving end (226) of the sample collection device. The first end of a channel can be an open end capable of receiving a sample. In some embodiments, the ends of each channel can be provided at the sample receiving end of the sample collection device. One, two, or more channels can have a first end at the sample receiving end of the sample collection device. Separate channels can be used to minimize the risk of cross-contamination of blood between one channel and another channel. Optionally, channels can have an inverted Y configuration, with channels starting on a common channel and undergoing separation into two or more channels. This Y setting can be useful in situations where contamination is not an issue. Optionally, an alternative method for a Y configuration would be to have a straight channel and have the sample collection containers move, sequentially, to wrap the same needle as a straight channel.
[0049] In some cases, a plurality of channels may be provided. The ends of the channels at the receiving end of the sample may be in close proximity to each other. The ends of the channels at the receiving end of the sample can be adjacent to each other. The ends of the channels at the receiving end of the sample may contact each other, or may be within 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm , 9 mm, 10 mm, 12 mm, 15 mm, or 20 mm from another end to end, or center to center. The channels may diverge from each other from the sample receiving end. For example, the other ends of the channels opposite the ends of the channels at the receiving end of the sample can be spaced apart. They can be more than or equal to about 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm, 10 mm, 12 mm, 15 mm, 20 mm, 25 mm, or 30 mm between itself edge to edge or center to center.
[0050] In some embodiments, the body (220) may have an elongated shape. The body may have one or more tapered portions (228) at or near the sample receiving end (226). The sides of the body can converge at the receiving end of the sample. The tapered portion and / or sample receiving end can be curved. Alternatively, edges can be provided. A surface of the tapered portion can be provided at any angle to the longitudinal axis of the device. For example, the tapered portion may be about 5 degrees, 10 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees or 75 degrees from the longitudinal axis.
[0051] The sample receiving end (226) of the device can be contacted with a sample. The sample can be delivered directly from the patient. The sample receiving end may come into contact with the patient or with a sample that is in contact with or being withdrawn from the patient. For example, the receiving end of the sample may contact a drop of blood on a patient's finger. Blood can enter the channels. Blood can be transported through the channels through capillary action, pressure differential, gravity, or any other driving force. Blood can travel through the channels from a sample receiving end to a sample dispensing end. The dispensing end of the sample can be in fluid communication or can be put in fluid communication with one or more containers housed within a base of the device. The sample can pass the channels to the containers. The sample can be guided to the containers through pressure differential, capillary action, gravity, friction, and / or any other driving force. Optionally, the sample can also be introduced into the blood with a pipette, syringe, etc. It should be understood that, although Figure 2B shows that sample B only partially filling the channels (222a, 222b), but in most embodiments, the channels will be completely filled with sample B when the filling process is complete.
[0052] Figures 3A-3B show an example of a sample collection device (300) before placing channels (322a, 322b) in fluid communication with one or more containers (346a, 346b) housed within a base ( 340) of the device. The sample collection device may include a cover (310), body (320), support (330) and base (340). The body and / or support can support and / or cover at least a portion of one, two or more channels. The base can support and / or cover one, two or more containers.
[0053] In one embodiment, a body (320) and / or support (330) can support one or more channels (322a, 322b) of the sample collection device. In one example, two channels are provided, although descriptions regarding the embodiment of two channels can apply to any number of channels, including, but not limited to, 1, 3, 4, 5, 6, or more channels. Each channel can have a first end (323a, 323b) that can be provided at a sample receiving end (326) of the device. The first ends of the respective channels can be opened. The channels can be opened to ambient air. When the first ends of the channels come into contact with a fluid, such as blood, the fluid can be drawn into the channels. Blood can be aspirated through capillary action, or any of the techniques described here elsewhere. Blood can travel along the length of the channels to the respective second ends (325a, 325b) of the channels. The channels can be fluidly segregated from each other. For example, a fluid can enter a first channel (322a) through a first end (323a), pass through the length of the channel, and exit the first channel (325a) at the second end. Likewise, the fluid can enter a second channel (322b) through a first end (323b), pass through the length of the channel, and exit the second channel at the second end (325b). The first and second channels can be fluidly segregated so that the fluid from the first channel does not pass to the second channel and vice versa. In some embodiments, the fluid can pass to the second ends of the channels, without initially leaving.
[0054] The channels (322a) and (322b) can have a divergent configuration. For example, the first ends (323a), (323B) of the channels may be closer together than the second ends (325a), (325b) of the channels. More space can be provided between the second ends of the channels than between the first ends of the channels. The first ends of the channels may or may not be in contact with each other. The first ends of the channels can be adjacent to each other.
[0055] A base (340) can be connected to a support (330) of the sample collection device. The base (340) may or may not contact support directly. The base can be movable in relation to the support when using the device. In some embodiments, the base can slide in a longitudinal direction in relation to the support. In some cases, the base may slide in a longitudinal direction relative to the support without rotation. In some cases, the base can slide coaxially with the support, without rotation. In some cases, a base may rotate while moving in relation to the support. A portion of the base may fit within a portion of the support, or vice versa. For example, a part of the base can be inserted into a portion of the support and / or a part of the support can be inserted into the base. One or more stop features can be provided on the base and / or support to provide a controlled degree of movement between the base and the support. The stop feature can include a shelf, protrusion or crack.
[0056] The base (340) may be able to support one or more containers (346A, 346B). The base may have a housing, which may at least partially involve one or more containers. In some cases, the containers can be completely surrounded when the base is attached to a support (330). The base may have one or more indentations, protrusions, crevices, or shape features to accept the containers. The base can be formed with a shape that is complementary to the shape of the containers. The containers can be held in an upright position in relation to the base.
[0057] The same number of containers can be provided as the number of channels. For example, if N channels are provided, then N containers must be provided, where N is a positive integer (for example, 1, 2, 3, 4, 5, 6, 7, 8, or more). Each channel can correspond to a respective container. In one example, a sample collection device may have a first channel and a second channel, as well as a respective first container and second container. A first channel (322a) can be or can be configured to be in fluid communication with a first container (346a), and a second channel (322b) can be or can be configured to be in fluid communication with a second container (346b).
[0058] In some embodiments, each container may have a body (349a, 349b) and a lid (348a, 348b). In some cases, the container body can be formed from a transparent or translucent material. The container body can allow a sample provided within the container body to be visible when viewed from outside the container. The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered and rounded, or any combination thereof. The containers can comprise an open end and a closed end. The open end can be a top end of the container, which can be at the end of the container closest to one or more channels. The closed end can be a bottom end of the container, which can be at the end of the additional container of one or more channels. Various embodiments of containers can be described in greater detail here elsewhere.
[0059] A base (340) can have one or more optical indicators, such as optical windows (342a, 342b). Optical windows can be positioned over containers (346a, (346b). In some cases, optical windows can be positioned over container bodies. A single window can provide a view of a single container or multiple containers. In one example, the same number of optical windows can be provided as containers. Each optical window can correspond to a respective container. Both the optical window and the containers can be formed of an optically transmitting material that can allow a user to see if a sample has reached the container. outside the sample collection device.
[0060] In some embodiments, there may be optical windows of the channels (322a) and (322b), so that a user can observe when a desired level of filling has been reached in the channels. In some embodiments where the body (320) is completely transparent or translucent, there may be a marker or indicator along the channels to notice when a desired level of filling has been achieved.
[0061] The containers can be sized to contain a small sample of fluid. In some embodiments, the containers can be configured to contain no more than about 5 ml, 4 ml, 3 ml, 2 ml, 1.5 ml, 1 ml, 900 μl, 800 μl, 700 μl, 600 μl, ( 500) μl, 400 μl, 300 μl, 250 μl, 200 μl, 150 μl, 100 μl, 80 μl, 50 μl, 30 μl, 25 μl, 20 μl, 10 μl, 7 μl, 5 μl, 3 μl, 2 μl, 1 μl, 750 nl, (500) nl, 250 nl, (200) nl, 150 nl, 100 nl, 50 nl, 10 nl, 5 nl, or 1 nl. The containers can be configured to contain no more than a few drops of blood, a drop of blood, or no more than a portion of a drop of blood.
[0062] The containers may contain a lid (348a, 348b). The lid can be configured to fit over an open end of the container. The lid can block the open end of the container. The lid can seal the container fluidly. The lid can form a fluid-tight seal with the container body. For example, the lid may be impermeable to gas and / or liquid. Alternatively, the cap may allow some gases and / or liquids to pass. In some cases, the lid may be permeable to gas and impermeable to liquids. The lid may be impermeable to the sample. For example, the cap may be impermeable to whole blood, serum or plasma. In some cases, a portion of the lid may fit with a portion of the container body. The lid can form a stopper with the container body. The lid may include a lip or shelf that may fall over a portion of the container body. The lip or shelf may prevent the lid from sliding into the body of the container. In some cases, a portion of a lid may overlap with an upper and / or lateral part of the container body. Any description of containers here can be applied in combination with the sample collection device. Optionally, some embodiments may include an additional part in the vessel assembly, such as a lid support. In one embodiment, the purpose of the lid support is to maintain a tight seal between the lid and the container. In one embodiment, the lid support engages an attachment, lip, indentation, or other connection location on the outside of the container to hold the lid in place. Optionally, some embodiments can combine both the lid and the lid holder in a single component.
[0063] One or more coupling assemblies may be provided. The coupling assembly may include a channel support (350) and / or a force-exiting component, such as a spring (352) or elastic. In one embodiment, the support (350) can maintain the adapter channel (354) attached to the support. As will be described here elsewhere, the adapter channel (354) can be integrally formed with the collection channel or it can be a discrete element that can be an independent part, a part of the collection channel, or part of the container. In one embodiment, the support (350) can prevent the channel adapter (354) from sliding with respect to the support. The support (350) can optionally provide a support on which a component of exerting force, such as a spring, can rest.
[0064] In one example, each coupling assembly may include a spring (352) that can exert a force so that the base (340) is in an extended state, when the spring is in its natural state. When the base is in its extended state, a space can be provided between the containers (346a, (346b) and the coupling assemblies. In some cases, when the base (340) is in its extended state, the second ends of the channels they may or may not contact the container lids.The second ends of the channels (325a) and (325b) may be in a position where they are not in fluid communication with the interior of the containers.
[0065] A sample collection device can have any number of coupling sets. For example, the same number of coupling sets can be provided with the number of channels. Each channel can have a coupling set. For example, if a first channel and a second channel are provided, a first set of latches can be provided for the first channel and a second set of latches can be provided for the second channel. The same number of coupling sets and containers can be granted.
[0066] In one embodiment, the coupling assembly can accommodate an adapter channel (354), such as, but not limited to, an elongated, tapered or pointed end (327a and 327b). It should be understood that in some embodiments the ends (327a and 327b) are part of a needle that is formed separately from the channels (322a) and (322b) and then coupled to the channels (322a) and (322b) . The needles can be formed from the same or different material of the body defining the channels (322a) and (322b). For example, some may use a metal to form the needles and a polymeric or plastic material to define the channels of the body (322a) and (322b). Optionally, some embodiments can form ends (327a and 327b) in an element that is integrally formed with the channels (322a) and (322b). In some cases, the second end of the channel can be configured to penetrate a material, such as a lid (348a, 348b) of the container. In some embodiments, a portion of the adapter channel (354) may be insertable into the collection channel or a portion of the collection channel may be insertable into the adapter channel, or both may be configured to align flush. Optionally, some embodiments can integrally form the adapter channel (354) with the collection channel (322a). It should be understood that Figure 3B (and 4B) shows sample B only partially filling the channels (122a, 122b), but in most embodiments, the channels will be completely filled with sample B when the filling process is completed. There may be variations and alternatives to the embodiments described herein and a single embodiment should not be interpreted in a way that covers the entire invention.
[0067] Figures 4A-4B show an example of a sample collection device (400) that has channels (422a, 422b) that are in fluid communication with the interior of containers (446a, 446b) within the device. The sample collection device may include a cover (410), body (420), support (430) and base (440). The body and / or support can support and / or cover at least a portion of one, two or more channels. The base can support and / or cover one, two or more containers.
[0068] In one embodiment, a body (420) and / or support (430) can support one or more channels (446a, 446B) in a sample collection device. For example, a first channel and a second channel can be provided. Each channel can have a first end (423a, 423b) which can provide a sample receiving end (426) of the device. The first ends of the respective channels can be opened. The channels can be opened to ambient air. When the first ends of the channels come into contact with a fluid, such as blood, the fluid can be drawn into the channels. The fluid can be aspirated through capillary action, or any of the techniques described here elsewhere. The fluid can travel along the length of the channels to the respective second end (425a, 425b) of the channels. In some embodiments, the fluid can reach the second ends of the channels through a capillary action or other techniques described herein. In other embodiments, the fluid does not need to reach the second ends of the channels. The channels can be fluidly segregated from one another.
[0069] In some embodiments, the fluid can pass to the second ends of the channels without leaving when the channels are not in fluid communication with the interior of the containers (446a, 446b). For example, fluid can be drawn into the channel through capillary action, which can cause fluid to flow to or near the end of the channel, without causing the fluid to leave the channel.
[0070] A base (440) can be connected to a support (430) of the sample collection device. The base can be movable in relation to the support when using the device. In some embodiments, the base can slide in a longitudinal direction in relation to the support. In one example, the base may have (i) an extended position, in which the channels are not in fluid communication with the interior of the containers, and (ii) a compact position in which the channels are in fluid communication with the interior of the containers. A sample collection device can initially be provided in an extended state, as shown in Figure 3. After the sample has been collected and carried across the length of the channel, a user can push the base and provide the sample collection device with the be compressed state, as shown in Figure 4. Once the base has been pushed in, the base can naturally remain compressed, or it can bounce back and out to an expanded state, once the buoyant force is removed . In some cases, a base can be pulled out to an expanded state, or it can be pulled out completely to provide access to the containers therein.
[0071] The base (440) may be able to support one or more containers (446a, 446b). The base may have a housing, which may at least partially involve one or more containers. In some cases, the containers can be completely surrounded when the base is attached to a support (430). The base may have one or more indentations, protrusions, cracks or recesses in order to accept the containers. The base can be formed with a shape that is complementary to the shape of the containers. The containers can be held in an upright position in relation to the base.
[0072] The same number of containers can be provided as the number of channels. Each channel can correspond to a respective container. In one example, a sample collection device may have a first channel and a second channel, as well as respective first container and second container. A first channel (422a) can be in or can be configured to be in fluid communication with a first container (446a), and a second channel (422b) can be in or can be configured to be in fluid communication with a second container (446b). The first channel may initially not be in fluid communication with a first container and the second channel may initially not be in fluid communication with the second container. The first and second channels can be placed in fluid communication with the interior of the first and second containers, respectively, when the base is pushed in relation to the support. The first and second channels can be placed in fluid communication with the first and second containers simultaneously. Alternatively, they do not need to be in fluid communication simultaneously. The timing of fluid communication may depend on the height of the container and / or the length of the channel. The timing of fluid communication can depend on the relative distances between the second end of the channel and the container.
[0073] In some embodiments, each container may have a body (449a, 449b) and a lid (448a, 448b). The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered and rounded, or any combination thereof. The containers can comprise an open end and a closed end. The open end can be a top end of the container, which can be an end of the container closest to one or more channels. The closed end can be a bottom end of the container, which can be at the long end of the container of one or more channels.
[0074] A base (440) can have one or more optical indicators, such as optical windows (442a, 442b). The optical windows can be positioned over the containers (446a, 446b). In some cases, optical windows can be positioned over the bodies of containers. Both the optical window and the containers can be formed of an optically transmitting material that allows a user to see if a sample has reached the container from outside the sample collection device. In some embodiments, the containers may incorporate marking on the containers themselves to indicate filling levels.
[0075] The containers may contain a lid (448a, 448b). The lid can be configured to fit over an open end of the container. The lid can block the open end of the container. The lid can seal the container fluidly. The lid can form a fluid-tight seal with the container body. For example, the cap may be impermeable to whole blood, serum or plasma. In some cases, a portion of the lid may fit with a portion of the container body. The lid can include a lip or shelf that can hang over a portion of the container body. In some embodiments, the cap may have a cavity or depression. The cavity or depression can help guide a second end of the channel to the center of the lid. In some cases, when the sample collection device is in an extended state, a second end of a channel (425a, 425b) may be located above the container lid. The second end of the channel may or may not contact the container lid. In some cases, the second end of the channel may rest within a cavity or depression in the lid. In some cases, the second end of the channel can partially penetrate the lid without reaching the interior of the container. Optionally, some embodiments of the lid may include a crimp portion for holding a vacuum.
[0076] A second end of a channel can have an angled, conical or pointed end (427a) and (427b). It should be understood that in some embodiments the ends (427a) and (427b) are part of a needle that is formed separately from the channels (422a) and (422b) and then coupled to the channels (422a) and (422b). The needles can be formed from the same or different material of the body that defines the channels (422a) and (422b). For example, some may use a metal to form the needles and a polymer or plastic material for the body that defines the channels (422a) and (422b). Optionally, some embodiments can form the ends (427a) and (427b) into an element that is integrally formed with the channels (422a) and (422b). In some cases, the second end of the channel can be configured to penetrate a material, such as a lid (448a, 448b) of the container. The cover can be formed of a material that can prevent the passage of the sample in the absence of a penetrating element. The lid can be formed from a single solid part. Alternatively, the cap can include a slot, opening, hole, thin portion, or any other feature that can accept a penetrating element. A groove or other opening may be able to hold the sample inside, when the penetrating element is not in the slot or opening, or when the penetrating element is removed from the slot or opening. In some cases, the cap can be formed from a self-curing material, so that when a penetrating element is removed, the opening formed by the penetrating element closes. The second end of the channel can be a penetrating element that can pass through the lid into the container. In some embodiments, it should be clear that the penetrating element may be a hollow needle that allows the sample to pass, and not just piercing needles. In some embodiments, the drill tip may have a non-pointed design such as, but not limited to, a tapered cannula that penetrates without unraveling the lid material.
[0077] One or more coupling sets can be provided. The coupling assembly may include a support channel (450) and / or a force-exiting component, such as a spring (452) or elastic. In one embodiment, the support (450) can maintain the adapter channel (454) attached to the support. As will be described here elsewhere, the adapter channel (454) can be integrally formed with the collection channel or it can be a discrete element that can be an independent part, part of the collection channel, or part of the container. In one embodiment, the support (450) can prevent the adapter channel (454) from sliding with respect to the support. The support (450) can optionally provide a support on which a component of exerting force, such as a spring, can rest.
[0078] In one example, the coupling assemblies may include a spring (452) which can exert a force such that the base is in its extended state when the spring is in its natural state. When the base is in its extended state, a space can be provided between the containers (446a), (446b) and the coupling assemblies. The second ends of the channels (425a, 425b) may be in a position where they are not in fluid communication with the interior of the containers.
[0079] A sample collection device can have any number of coupling sets. For example, the number of coupling sets provided can be the same as the number of channels. Each channel can have a coupling set. For example, if a first channel and a second channel are provided, a first coupling set can be provided for the first channel, and a second coupling set can be provided for the second channel. In one embodiment, the same number of coupling assemblies and containers can be provided.
[0080] When the base is pressed in, the spring (452) can be compressed. The second ends (425a, 425b) of the channels can penetrate the lids of the containers. The second ends of the channels can enter the interior of the container. In some cases, a force may be provided to guide the fluid from the channels to the containers. For example, a pressure differential can be generated between the first and second ends of the channels. Positive pressure can be provided at the first end (423a, 423b) of the channels and / or negative pressure can be provided at the second end of the channels. The positive pressure can be positive relative to the pressure at the second end of the channel and / or ambient air. The negative pressure can be negative in relation to the pressure at the first end of the channel and / or ambient air. In one example, the containers can have a vacuum in them. When the second end of a channel enters a container, the negative pressure inside the container can withdraw the sample into the container. In alternative embodiments, the sample can enter the container driven by capillary forces, gravity, or any other driving force. There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[0081] In some cases, different types of driving forces can be used at different stages of sample collection. Thus, one type of driving force can be used to drive the sample into the channel and then a different type of driving force can be used to move the sample from the channel into the container. For example, a capillary force can drive the sample into a channel and a pressure differential can drive the sample from the channel into the container. Any combination of driving forces can be used to drive the sample into the channel and into the container. In some embodiments, the driving force (s) used to drive the sample into the channel is different from the driving force (s) used to drive the sample into the container . In some alternative embodiments, the driving force may be the same for each phase. In some embodiments, the driving forces are applied sequentially or over defined periods of time. As a non-limiting example, the driving force to extract the samples into the container is not applied until at least one channel has reached a minimum filling level. Optionally, the driving force to drive the sample into the container is not applied until at least two channels have each reached a minimum filling level for said channel. Optionally, the driving force to drive the sample into the container is not applied until all channels have reached a minimum fill level for each channel. In some embodiments, the driving forces are applied simultaneously.
[0082] Some embodiments may use a source of pressurized gas coupled to the sample collection device and configured to push a body fluid collected from one or more channels into the respective containers. Optionally, some may use a vacuum source not associated with the containers to pull the fluid sample into the containers.
[0083] In addition, some ways of carrying out the channel can be configured in such a way that there is sufficient capillary force inside the channel such that, once filled, the force is greater than the force of gravity, so that the sample does not escapes the channel based only on the force of gravity. An additional driving force is used to break the influence of the capillarity action of the channel (s). Optionally, as described herein elsewhere, a device such as, but not limited to, a sleeve can contain body fluid exiting the channel at the end closest to the container, thereby minimizing any loss until transfer to the container is initiated.
[0084] Optionally, other materials such as, but not limited to, a lyosphere, sponge, or other driving force provider, can be used to deliver the driving force that draws the sample into the container. When several forces are used, this can be a primary, secondary or tertiary driving force to drag the sample into the container. Optionally, some embodiments may include a pressure type driving force provider, such as, but not limited to, a plunger to move the sample in a desired manner.
[0085] Some time after the sample has been introduced into a channel to travel along the length of the channel. A user can insert a sample into the sample collection device and can wait for the sample to travel the length of the channel. One or more optical indicator can be provided, which can indicate if the sample has reached a desired level of filling, this is not limited to the end of the channel. In other embodiments, the user can wait a predetermined period of time before pushing the base. The base can be pushed in after the user has determined that the sample has traveled a sufficient distance from the channel and / or a sufficient amount of time has passed since the sample was introduced. After the base is pushed in, the channels can be placed in fluid communication with the containers, and the sample can flow from the channel to the containers. An optical indicator can be provided so that a user can know when the containers have been filled.
[0086] Once the containers have been filled, they can be transferred to a desired location, using the systems and methods described here. In some cases, the entire sample collection device can be transferred. The cap can be placed on the sample collection device for transfer. In other embodiments, the base portion and / or support portion may be removable from the rest of the device. In one example, the base can be removed from the sample collection device, and the containers can be transferred along with the base. Alternatively, the base can be removed from the sample collection device to allow access to the containers, and the containers can be removed from the device and transmitted. Removing the base may involve some disassembly of the sample collection device to remove the base. This may involve using sufficient force to overcome detectors or stops built into the device to prevent accidental disengagement. Optionally, some other means, such as, but not limited to, a release latch or other locking mechanism can be used by a user before separating the base. Optionally, some embodiments may allow the containers to be removed without removing the base, but allow access to the containers through openings, access doors, or lids capable of opening at the base.
[0087] In some embodiments, one or more of the channels and / or containers may comprise characteristics described here elsewhere, such as separation elements, coatings, anticoagulants, granules, or any other characteristics. In one example, the sample introduced into the sample collection device may be whole blood. Two channels and respective containers can be provided. In this non-limiting example, each channel has a coating such as, but not limited to, an anticoagulant coating on the channel. Such anticoagulant coating can serve one or more of the following functions. First, the anticoagulant can prevent whole blood from coagulating within the canal during the sampling process. Depending on the amount of whole blood to be collected, premature clotting can clog the canal before sufficient blood has been brought into the canal. Another function is to introduce anticoagulant in the entire blood sample. By having the anticoagulant in the channel, this process can start the collection process earlier in relation to some embodiments that can only have it in the containers (446a) or (446b). This early introduction of anticoagulant may also be advantageous if the blood sample is conducted along a route that may have portions that are not coated with anticoagulant, such as, but not limited to, the inner surfaces of a needle attached to the channels (422a) or (422b). Optionally, some embodiments can include surfactants that can be used to modify the contact angle (wettability) of a surface.
[0088] In some embodiments the inner surface of the channel and / or other surfaces along the fluid path, such as, but not limited to, sample entry into a sample collection container can be coated with a surfactant and / or an anticoagulant solution. The surfactant provides a wettable surface for the hydrophobic layers of the fluid device and facilitates the filling of the measurement channel with the liquid sample, for example, blood. The anticoagulant solution helps to prevent blood clots from forming in the sample, for example when provided with the fluid device. Examples of surfactants that can be used include, without limitation, Tween, Tween® 20, Thesit®, sodium deoxycholate, Triton, Triton X-100, Pluronic and / or other non-hemolytic detergents that provide the appropriate wetting characteristics of a surfactant. EDTA and heparin are non-limiting anticoagulants that can be used. In a non-limiting example, the solution embodiment comprises 2% Tween, 25 mg / ml EDTA in 50% methanol / 50% H2O, which is then air dried. A methanol / water mixture provides a means of dissolving EDTA and Tween, and it also dries quickly from the surface of the plastic. The solution can be applied to the channel or other surfaces along the fluid flow path using any technique that will ensure a uniform film on the surfaces to be coated, such as, for example, pipetting, spraying, printing, or draining.
[0089] It should also be understood by any of the modalities here that a coating on the channel can extend along the entire path of the channel. Optionally, the liner can cover most, but not the entire channel. Optionally, some embodiments may not cover the channel in the areas closest to the inlet opening to minimize the risk of cross-contamination, where the liner material migrates from one channel to the nearby channels, through all channels being in contact. contact with the target sample fluid at the same time and thus have a fluid connection path.
[0090] Although embodiments are shown here with two separate channels on the sample collection device, it should be understood that some embodiments may use more than two separate channels. Optionally, some embodiments may use less than two completely separate channels. Some embodiments may use only a separate channel. Optionally, some embodiments can use an inverted Y-shaped channel, which starts initially as a channel and then splits into two or more channels. Any of these concepts can be adapted for use with other embodiments described here. Collection device with self-supporting collection channels
[0091] Figures 5A-5B provide another example of a sample collection device (500) provided in accordance with an embodiment described herein. The sample collection device may include a collection device body (520), support (530) and base (540). In some cases, a cover can optionally be provided. The collection device body may contain one or more collection channels (522a, 522b) defined by collection tubes, which may be able to receive the sample. The base may have one or more optical indicators (542a, 542b) that can provide a visual indication if the sample has reached one or more containers housed in the base. A support can have one or more optical indicators (532a, 532b) that can provide a visual indication if the sample has reached or exceeded a portion of the channels.
[0092] A sampling device body (520) of a sampling device can contain at least a portion of one or more tubes with channels (522a, 522b) in it. Optionally, the collection device body (520) can also define channels that couple with channels (522a, 522b) defined by the tubes. In some embodiments, a portion of the channels may extend beyond the body of the collection device. The channels can extend beyond one end or both ends of the collection device body.
[0093] The collection device body (520) can be connected to a support (530). The holder may contain a portion of one or more channels in it. The body of the collection device can be permanently attached to the support or it can be removable in relation to the support. In some cases, the collection device body and the support can be formed of a single integral part. Alternatively, the collection device body and the support can be formed from separate parts.
[0094] During the operation of the device the body of the collection device (520) and the support (530) can move relative to each other. In some cases, a body part (520) may be insertable into the holder (530) and / or a part of the holder may be insertable into the body. The body may be able to move relative to the support. In some cases, a sample collection device may have a longitudinal axis that extends along the length of the sample collection device. The body and / or the support can move in relation to each other in the direction of the longitudinal axis. The body and / or the support may be able to move a limited distance from each other. The body and / or support can move co-axially without rotation. Alternatively, rotational movement can be provided.
[0095] The body of the collection device (520) can be formed from an optically transmissive material. For example, the body of the collection device can be formed from a transparent or translucent material. Alternatively, the body can be formed from an opaque material. The support (530) can be formed from an optically opaque, translucent or transparent material. The holder may or may not have the same optical characteristics as the collection device body. The support can be formed from a material other than the body collection device, or from the same material as the body of the collection device. There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[0096] The body of the collection device, support and / or base can have any shape or size. In some instances, the body of the collecting device, support, and / or the base may be circular, elliptical, triangular, quadrangular (e.g. square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other shape cross section. The shape of the cross section can remain the same or it can vary along the length. The shape of the cross section can be the same for the body, support, base, or it can vary. In some cases, the body of the collection device, support, and / or the base may have a cross-sectional area less than or equal to about 10 cm2, 7 cm2, 5 cm2, 4 cm2, 3 cm2, 2.5 cm2, 2 cm2, 1.5 cm2, 1 cm2, 0.8 cm2, 0.5 cm2, 0.3 cm2, or 0.1 cm2. The cross-sectional area may vary or may remain the same along the length. The cross section size can be the same for the collection body, support, and / or base, or it can vary. The body of the collection device, support, and / or the base may be less than or equal to approximately 20 cm, 15 cm, 12 cm 10 cm, 9 cm, 8 cm, 7 cm, 6 cm, 5 cm cm, 4 cm, 3 cm, 2 cm, 1 cm, 0.5 cm, or 0.1 cm. The body of the collection device can be longer or shorter than the support or base, or a length equal to the support or base.
[0097] The channels (522a, 522b) can be supported by the device body (520) and / or the support (530). In some cases, the entire length of the tubes or the channels contained therein may be included within the assembly of the device body and the support. Alternatively, the channels can extend beyond the body and / or support device as seen in Figure 5. In some cases, the channels can extend beyond one end of the device, body / support combination , or beyond both ends. In some cases, a portion of the channels may be within the body of the device and a portion of the channels may be within the holder. The position of the channels can be bet by the body of the device and / or the support. In some cases, the channels can be attached to the device body and / or move in relation to the device body. The channels can be mobile in relation to the support. In some cases, a plurality of channels may be provided. At least part of the channels can be substantially parallel to each other. The channels can be parallel to each other and / or to a longitudinal axis that extends along a length of the sample collection device. Alternatively, none of the channels need to be parallel to each other. In some cases, at least part of the channels are not parallel to each other. The channels can be slightly folded. Optionally, they can be straight, but aligned to be close to each other as they are close to the sampling point. It should be understood that the tubes defining channels (522a) and (522b) can be made of optically transparent, transmissive, or other material sufficient to provide a detectable change in the sample that has reached a desired filling level in at least a channel. Optionally, the detectable variation can be used to detect when both channels reach at least the desired filling level.
[0098] A base (540) can be provided within the sample collection device. The base can be connected to the support (530). In some cases, a portion of the base (540) can be inserted into the holder (530) and / or a part of the holder can be insertable into the base. The base can be fixed in relation to the support or it can be movable in relation to the support. The base can be provided at the end of the support opposite the end of the support connected to the body. The base can be formed as a separate part of the support. The base can be detachable from the support. Alternatively, the base can be attached to the support and / or formed as an integral part with the support.
[0099] A base (540) can accommodate one or more containers in it. The containers can be in fluid communication with the channels and / or can be placed in fluid communication with the channels. An end of a channel can be inside the container or can be inserted into the container. The base may have one or more optical indicators (542a, 542b) that can provide a visual indication of whether the sample reaches one or more containers housed in the base. In some embodiments, the optical indicators can be optical windows that can allow a user to see into the base. The optical window can be formed from a transparent and / or translucent material. Alternatively, the optical window can be an opening without any material in it. The optical window can allow a user to directly view a container inside the base. The container inside the base can be formed of a transparent and / or translucent material that can allow a user to see if a sample has reached the base container. For example, if blood is transported along the channel to the recipients, the recipients can show the blood in them. In other embodiments, the optical indicators may include other characteristics that may indicate that the container has been filled. For example, one or more sensors can be provided inside the base or the container which can determine whether a sufficient amount of sample has been provided inside the container. The sensor can produce a signal for an optical indicator on the base which can indicate whether the sample has been delivered to the container and / or the amount of sample that has been delivered to the container. For example, the optical indicator can include a display, such as an LCD screen, light display (for example, LED display), plasma display which can provide an indication that the containers have been sufficiently filled. In alternative embodiments, an optical indicator does not need to be provided, but alternative indicators can be provided, such as, but not limited to, an audio indicator, temperature controlled indicator, or other device that can indicate, by means of a detectable signal , such as one detectable by a user, when the containers have been filled.
[00100] A support (530) can have one or more optical indicators (532a, 532b) which can provide a visual indication if the sample has reached or passed through a portion of a channel housed by the support. In some embodiments, the optical indicators can be optical windows that can allow a user to see inside the holder. The optical window can be formed from a transparent and / or translucent material. Alternatively, the optical window can be an opening without any material in it. The optical window can allow a user to directly see part of a channel inside the holder. The channels can be formed from a transparent material and / or translucent material that can allow a user to see if a sample has reached the portion of the channel underlying the optical window. In other embodiments, optical indicators may include other characteristics that may indicate whether the sample has passed through a portion of the channel, such as sensors described elsewhere in this document.
[00101] Referring now to Figures 6A-6B, additional views of a sample collection device (500) are provided in accordance with an embodiment described herein.
[00102] In some embodiments, a portion of the tubes containing the channels (522a, 522b) may extend beyond the body of the collection device (520). The portion of the channels that extends beyond may include portions of the channels that are configured to receive a sample from the patient. In one example, the channels can have a first end (523a, 523b), which can be a sample that receives the end of the channels.
[00103] The channels can optionally be defined by a rigid material. Alternatively, the channels can be defined by a flexible material or they can have flexible components. The channels may or may not be designed to bend or curve. The channels may or may not be substantially parallel to each other. In some cases, the first ends of the channels may be some distance from each other, when in a relaxed state. The first ends of the channels can remain at a distance from each other during the operation of the device. Alternatively, the first ends of the channels can be brought together. For example, the first ends of the channels can be tightened together. Each open end of the channels can receive a sample separately. The sample can be received sequentially. The sample can be from the same individual. Alternatively, the channels may be able to receive the same sample simultaneously.
[00104] Channels (522a, 522b) may include one or more features mentioned elsewhere in this document. At least part of the channels can be substantially parallel to each other. Alternatively, the channels can be at angles to each other. In some embodiments, the channels may have a first end which may be at the sample receiving end (526) of the sample collection device. The first end of a channel can be an open end capable of receiving a sample. In some embodiments, the ends of each channel can be provided at the sample receiving end of the sample collection device. One, two, or more channels can have a first end in the sample that receives the end of the sample collection device.
[00105] In some embodiments, the device body (520) can be movable in relation to the support (530). A portion of the device body can be inserted into the holder, or vice versa. In one example, the body of the device may have a lip (527) and an inner portion 529. The lip may have a larger cross-sectional area than the inner portion. The inner portion may be able to be inserted into the support. The lip can act as a stop to prevent the entire body from being inserted into the support. The lip can rest on a supportive shoulder.
[00106] Figures 7A-7B show a partial sectional view of an example of a sample collection device (700) provided according to an embodiment described herein. The sampling device in an extended state, before placing the channels (722a, 722b) in fluid communication with one or more containers (746a, 746b) housed within a base (740) of the device. The sample collection device may include a body (720), support (730) and base (740). The support body can support and / or cover at least a portion of one, two or more channels. The base can support and / or cover one, two or more containers. There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[00107] In one embodiment, a body (720) and / or support (730) can support one or more channels (746a, 746b) in a sample collection device. In one example, two channels are provided, although the descriptions relating to the two channel embodiment may apply to any number of channels, including, but not limited to, 1, 3, 4, 5, 6 or more channels. Each channel can have a first end ((723a), 723b), which can be a sample receiving end of the device. The first ends of the respective channels can be opened. The channels can be opened to ambient air. When the first ends of the channels are in contact with a fluid, such as blood, the fluid can be drawn into the channels. The fluid can be aspirated through capillary action, or any of the techniques described here elsewhere. The fluid can travel along the length of the channels to the respective second ends of the channels. The channels can be fluidly segregated from one another. For example, a fluid can enter a first channel (722a) through a first end (723a), pass through the length of the channel and exit the first channel at the second end. Likewise, the fluid can enter a second channel (722b) through a first end (723b), pass through the length of the channel and exit the second channel at the second end. The first and second channels can be fluidly segregated, so that the fluid from the first channel does not pass to the second channel and vice versa. In some embodiments, the fluid can pass to the second ends of the channels, without initially leaving.
[00108] The channels (746a, 746b) can be configured in parallel. For example, the first ends (723a), (723b) of the channels can be approximately the same distance from each other, as the second ends of the channels. The first ends of the channels may or may not be in contact with each other.
[00109] A support (730) can have one or more optical indicators, such as optical windows (732a, 732b). Optical windows can be positioned along the channels (722a), (722b). In some cases, the optical windows can be positioned over the portions of the channels. A single window can provide a view of a single portion of the channel or multiple parts of the channel. In one example, the same number of optical windows can be provided as channels. Each optical window can correspond to a respective channel. Both the optical window and the channels can be formed of an optically transmitting material that can allow a user to see if a sample has reached and / or passed through the underlying part of the channel from the outside of the sample collection device. This determination can be useful in determining when to compress the sample collection device.
[00110] A base (740) can be connected to a support (730) of the sample collection device. The base may or may not be able to contact support directly. The base can be fixed in relation to the support when using the device. In some cases, the base can be removed from the holder. A portion of the base can be inserted into the holder and / or vice versa. In some embodiments, the base can slide off the support, in a longitudinal direction in relation to the support. In some cases, the base can slide coaxially with the support, without rotation. In some cases, a base may rotate while moving in relation to the support.
[00111] The base (740) may be able to support one or more containers (746a, 746b). The base may have a housing, which may involve, at least partially, one or more containers. In some cases, the containers can be completely surrounded when the base is attached to a support (730). The height of the base can extend beyond the height of the containers. Alternatively, the height of the base can extend to the same degree or less than the height of the containers. The base may have one or more indentations, protrusion, crack, or feature in order to accept the containers. The base can be formed with a shape that is complementary to the shape of the containers. For example, the base may have one or more tube-shaped indentation, into which the tube-shaped containers can fit comfortably. The containers can rub against the base. The containers can be held in an upright position in relation to the base. There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[00112] The same number of containers can be provided as the number of channels. For example, if N channels are provided, then N containers can be provided, where N is a positive integer (for example, 1, 2, 3, 4, 5, 6, 7, 8, or more). Each channel can correspond to a respective container. In one example, a sample collection device may have a first channel and a second channel, as well as a respective first container and second container. A first channel (722a) can be in or can be configured to be in fluid communication with a first container (746a), and a second channel (722b) can be in or can be configured to be in fluid communication with a second container (746b).
[00113] In some embodiments, each container may have a body (749a, 749b) and a lid (748a, 748b). Containers can have any features or characteristics described in this document.
[00114] A base (740) can have one or more optical indicators, such as optical windows (742a, 742b). The optical windows can be positioned over the containers (746a, 746b). In some cases, optical windows can be positioned over the bodies of containers. A single window can provide a view for a single container or for multiple containers. In one example, the same number of optical windows can be provided as containers. Each optical window can correspond to a respective container. Both the optical window and the containers can be formed of an optically transmitting material that can allow a user to see if a sample has reached the container from outside the sample collection device. Such a visual assessment can be useful in determining when the sample has reached the containers, and when the base can be removed from the sample collection device.
[00115] One or more coupling sets can be supplied. The coupling assembly may include a support channel (750) and / or a force-exiting component, such as a spring (752) or elastic. In one embodiment, the holder (750) can hold the adapter channel (754) attached to the holder. As will be described here elsewhere, the adapter channel (754) can be integrally formed with the collection channel or it can be a discrete element that can be an independent part, part of the collection channel, or part of the container. In one embodiment, the support (750) can prevent the adapter channel (754) from sliding with respect to the support. The support (750) can optionally provide a support on which a component of exerting force, such as a spring, can rest.
[00116] In one example, the coupling assemblies may include a spring (752) that can exert a force so that the body (720) is in an extended state, when the spring is in its natural state. When the body is in its extended state, a space can be provided between the containers (746a, 746b) and the coupling assemblies. When a body is in its extended state, the inner part (729) of the body can be exposed and / or discovered by the support (730). In some cases, when the body is in its extended state, the second ends of the channels (746a, 746b) may or may not contact the container lids. The second ends of the channels may be in a position where they are not in fluid communication with the interior of the containers. There may be variations and alternatives to the embodiments described herein and no embodiment should be construed to encompass the entire invention.
[00117] A sample collection device can have any number of coupling sets. For example, the same number of coupling sets can be provided as the number of channels. Each channel can have a coupling set. For example, if a first channel and a second channel are provided, a first coupling set can be provided to the first channel, and a second coupling set can be provided to the second channel. The same number of coupling assemblies and containers can be provided.
[00118] Figures 8A-8B provide an example of a sample collection device (800) that has channels (822a, (822b)) that are in fluid communication with the interior of containers (846a, 846b) inside the device . The sample collection device may include a body (820), support ((830)) and base ((840)). The body and / or support can support and / or cover at least a portion of one, two or more channels. The channels can extend beyond one end of the body. The base can support and / or cover one, two or more containers.
[00119] In one embodiment, a body (820) and / or the support ((830)) can support one or more channels (822a, (822b)) of a sample collection device. For example, a first channel and a second channel can be provided. Each channel can have a first end (823a, 823b), which can be provided to a sample receiving end of the device that can extend beyond the body. The first ends of the respective channels can be opened. The channels can be opened to ambient air. The channels can be rigid or they can be flexible. In some embodiments, the channels can be of a length that can allow them to be bent in contact with each other. When the first ends of the channels come into contact with a fluid, such as blood, the fluid can be drawn into the channels. Each end of the channel can be contacted separately with a fluid, which is drawn into the respective channel. This may involve folding the sample collection device so that only one opening into the channel is in contact with the fluid sample at any time. Alternatively, all channels can be contacted simultaneously with the same sample that is simultaneously pulled into the respective channels. Alternatively, several, but not all, channels can be simultaneously contacted with the same sample, which is then simultaneously pulled into the respective channels. The fluid can be aspirated through capillary action, or any of the techniques described here elsewhere. The fluid can travel along the length of the channels to the respective second ends of the channels. In some embodiments, the fluid can reach the second ends of the channels through a capillary action or other techniques described herein. In other embodiments, the fluid does not need to reach the second ends of the channels. The channels can be fluidly segregated from each other.
[00120] In some embodiments, the fluid can pass to the second ends of the channels without leaving when the channels are not in fluid communication with the interior of the containers (846a, 846b). For example, the fluid can be drawn into the channel through the capillary action, which can cause the fluid to flow near the end of the channel, without causing the fluid to leave the channel.
[00121] The body (820) can be movable in relation to the support (830) when using the device. In some embodiments, the body can slide in a longitudinal direction in relation to the support. In one example, the body may have (i) an extended position, in which the channels are not in fluid communication with the interior of the containers, and (ii) a compressed position, where the channels are in fluid communication with the interior of the containers . A sample collection device can initially be provided in an extended state, as shown in Figure 7. After the sample has been collected and carried across the length of the channel, a user can push the body in to provide the sample collection device. samples in their compacted state, as shown in Figure 8. In some cases, when the body is in an extended state, an inner part of the body is exposed. When the body is in a compressed state, the inside of the body can be covered by the support. An edge of the body can contact the support. Once the body has been pressed, the body can naturally remain compressed, or it can bounce back outward and into an expanded state, once the buoyant force is removed. In some cases, a body can be pulled out to an expanded state, or it can be pulled out completely to provide access to the containers in it. Optionally, in some assemblies, removal of the body will not provide access to the containers.
[00122] A base ((840)) can be connected to a support (830) of the sample collection device. The base ((840)) may be able to support one or more containers (846a, 846b). The base may have a housing, which may involve, at least partially, one or more containers. In some cases, the containers can be completely surrounded when the base is attached to a support (830). The base may have one or more indentations, protrusions, recesses, or conformation to accept the containers. The base can be shaped with a shape that is complementary to the shape of the containers. The containers can be held in an upright position in relation to the base.
[00123] The same number of containers can be provided as the number of channels. Each channel can correspond to a respective container. In one example, a sample collection device may have a first channel and a second channel, as well as a respective first container and second container. A first channel (822a) can be or can be configured to be in fluid communication with a first container (846a), and a second channel (822b) can be or can be configured to be in fluid communication with a second container (846b). The first channel may initially not be in fluid communication with a first container and the second channel may initially not be in fluid communication with the second container. The first channel and second channel can be placed in fluid communication with the interior of the first and second containers, respectively, when the body is pressed in relation to the support. The first and second channels can be placed in fluid communication with the first and second recipients simultaneously. Alternatively, they do not need to be in fluid communication simultaneously. The timing of fluid communication may depend on the height of the container and / or the length of the channel. The timing of fluid communication can depend on the relative distances between the second end of the channel and the container.
[00124] In some embodiments, each container may have a body (849a, 849b) and a lid (848a, 848b). The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. The bottom of the container can be flat, tapered and rounded, or any combination thereof. The containers can comprise an open end and a closed end. The open end can be a top end of the container, which can be the end of the container closest to one or more channels. The closed end can be a bottom end of the container, which can be the far end of the container of one or more channels. There may be variations and alternatives to the embodiments described herein and no single embodiment should be construed as covering the entire invention.
[00125] A support (830) can have one or more optical indicators, such as optical windows (832a, 832 b). The optical windows can be positioned over the channel portions (822a), (822b). Optical windows can provide an indicator if a sample has reached and / or passed through the part of the channels shown by the optical windows. This can be useful to assess whether the sample has drained enough for the user to push the body into the sample collection device. In some cases, it may be desirable for the sample to reach the second end of the channels, or close to the second end of the channels, before causing the channels to enter fluid communication with the containers. In some cases, it may be desirable for the sample to reach a certain portion of the channel before pushing the body in and bringing the channels into fluid communication with the containers. The right portion of the channel can be the base of the optical windows.
[00126] A base (840) can have one or more optical indicators, such as optical windows (842a, 842b). The optical windows can be positioned over the containers (846a), (846b). In some cases, optical windows can be positioned over the bodies of containers. Optical windows can provide an indicator if a sample has entered the containers. Optical windows can show how much of the sample has filled the containers. This can be useful to assess whether a sufficient amount of sample has entered the containers. In some cases, it may be desirable for a certain amount of sample to be introduced into the containers before removing the containers from the fluid communication with the channels. A predetermined volume of sample in the containers can be desired before removing a base from the device, thus providing the withdrawal of the containers from fluid communication with the channels.
[00127] The containers and / or interfaces with the channels can have any characteristic or functionality, such as those described here elsewhere. In some cases, a second end of the channel can penetrate a lid of the container, which causes the channel to communicate fluid with the container. In some cases, the channel can be removed from the container and the lid of the container can form a fluid-tight seal, thus allowing a fluid-tight environment inside the container, when the channel is brought out of fluid communication with the container.
[00128] One or more coupling sets can be provided. The coupling assembly may include a channel support and / or a force-exiting component, such as a spring or elastic. The support can keep the channel attached to the body. The support can prevent the channel from sliding in relation to the body. The support can optionally provide a support on which a force component, such as a spring, can rest.
[00129] In one example, the coupling assemblies can include a spring that can exert a force, so that the body is in its extended state, when the spring is in its natural state. When the body is in its extended state, a space can be provided between the containers (846a), (846b) and the lower portion of the sample body (820). The second ends of the channels may be in a position where they are not in fluid communication with the interior of the containers.
[00130] When the body is pressed, the spring (852) can be compressed (see also Figures 9A-9C). The second ends of the channels can penetrate the container lids. The second ends of the channels can penetrate inside the container. In some cases, a force can be provided to guide the fluid from the channels to the containers. For example, a pressure differential can be generated between the first and second ends of the channels. Positive pressure can be provided at the first end (823a, 823b) of the channels and / or negative pressure can be provided at the second end of the channels. The positive pressure can be positive relative to the pressure at the second end of the channel and / or ambient air. The negative pressure can be negative in relation to the pressure at the first end of the channel and / or ambient air. In one example, the containers (846a) and (846b) can each have a vacuum therein. When the second end of a channel enters a container, the negative pressure inside the container can suck the sample into the container. In alternative embodiments, the sample can enter the container by capillary forces, gravity, or any other driving force. Optionally, there can be single or multiple combinations of forces to fill the container with fluid.
[00131] In some cases, different types of driving forces can be used to drive the sample into the channel, and from the channel into the container. For example, a capillary force can pull the sample into a channel, and a pressure differential can take the sample from the channel into the container. Any combination of driving forces can be used to move the sample into the channel and into the container.
[00132] It may be some time after a sample has been introduced into a channel to travel along the length of the channel. A user can insert a sample into the sample collection device and can wait for the sample to travel the length of the channel. One or more optical indicators along the length of the channel can be provided, which can indicate whether the sample has reached the end of the channel. In other embodiments, the user can wait a predetermined period of time before pushing the body. The body can be pushed in after the user has determined that the sample has traveled a sufficient distance from the channel and / or a sufficient amount of time has passed since the sample was introduced. The body may have a flat surface that can be easy for the user to push. In some cases, the flat surface may have a cross-sectional area that may be sufficient for the user's fingers to press down on the body. After the body is pushed, the channels can be placed in fluid communication with the containers, and the sample can flow from the channel to the containers. An optical indicator can be provided so that a user can know when the containers have been filled.
[00133] Once the containers have been filled, they can be transferred to a desired location, using the systems and methods described here elsewhere. As previously described, the complete sample collection device can be transferred. In other embodiments, the base portion may be removable from the rest of the device. In one example, the base can be removed from the sample collection device, and the containers can be transferred along with the base. Alternatively, the base can be removed from the sample collection device to allow access to the containers, and the containers can be removed from the device and transmitted.
[00134] With reference now to Figures 9A-9C, examples of a sample collection device (900) and method of use will now be described. In a non-limiting example, the device may have a body (920), support (930) and a base (940). The body (920), the support (930) and the base (940) can be movable in relation to each other. In some cases, the various components of the devices can be mobile during the different stages of use. Examples of stages of use may include, when the device is in an extended state, in a compressed and separate state.
[00135] Figure 9A shows an example of the device (900) in an extended state. The body (920) can be extended with respect to the support. Channels (922a, 922b) configured to transport a sample, can be attached to the body. A first end of a channel can extend outwardly from the body and / or the rest of the sample collection device. A second end of the channel may be within and / or encompassed by a portion of the sample collection device. The channel can be fluidly isolated from a respective container housed by the base (940). The support (930) can be positioned between the body and the base. The support can include at least partially a portion of the channel. In some cases, the support may include the second end of the channel.
[00136] When in an extended state, the device may have an extended length. The length of the device can be from the bottom of the base to the first end of the channels. Alternatively, the length of the device can be measured from the bottom of the base to the top of the body.
[00137] As seen in Figure 9A, the device (900) can be in an extended state when the sample is introduced into the device. For example, a sample can be contacted by at least one first end of a channel. The sample can be dragged into the canal through a capillary action or any other technique or driving force described here. The forces can act alone or in combination to pull the sample in the device. The device (900) can remain in an extended state while the sample is traversing the channel. The sample can fill the entire length of the channel, a portion of the length of the channel, or at least a minimum portion to satisfy a sample acquisition volume
[00138] Figure 9B shows an example of the device (900) in a compressed state. The body (920) can be compressed in relation to the support. The channels (922a, 922b) can be attached to the body. The channels can be in fluid communication with their respective containers. When the device is placed in a compacted state, a first channel can be placed in fluid communication with an interior of a first container, and a second channel can be put in fluid communication with an interior of a second container.
[00139] As a non-limiting example, a user can push the body (920) towards the support (930) (or vice versa) to place the device in a compressed state. The relative movement between the pieces can involve the movement of both pieces. Optionally, the move may involve moving only one of them. In the present example, the body (920) can be pushed the entire length towards the support (930), so that no interior portion of the body is exposed and / or an edge contacts the support. Any stop mechanism can be used and can be activated when the device is completely compressed. Alternatively, the body can only be partially pressed. For example, a portion of the inner portion of the body may be exposed. The support can be positioned between the body and the base. The support can include at least partially a portion of the channel. In some cases, the second end of the channel may extend beyond the support of the device.
[00140] When in a state of compression, it should be understood that the device (900) can have a compressed length. The length of the device (900) can be from the bottom of the base to the first end of the channels. Alternatively, the length of the device can be measured from the bottom of the base to the top of the body. The compressed length of the device may be less than the extended length of the device. In some embodiments, the length of the compressed device can be at least about 0.1 cm, 0.5 cm, 1.0 cm 1.5 cm, 2.0 cm 2.5 cm, 3.0 cm , 3.5 cm, 4.0 cm, or 5.0 less than the extended length of the device. The tablet length of the device can be less than or equal to about 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 97% or 99% of the extended device length.
[00141] One or more coupling sets can be provided with the device (900). The coupling assembly may include a support channel (950) and / or a force-exiting component, such as a spring (952) or elastic. The holder (950) can hold the adapter channel (954) affixed to the holder. As will be described here elsewhere, the adapter channel (954) can be integrally formed with the collection channel or it can be a discrete element that can be an independent part, part of the collection channel, or part of the container. In one embodiment, the holder (950) can prevent the channel adapter (954) from sliding with respect to the holder. The support (950) can optionally provide a support on which a component of exerting force, such as a spring, can rest. The force-exiting component, such as a spring, can be in a compressed state when the device is in a compressed state. The spring can exert a force on the body of the device when the device is in a compressed state.
[00142] The device may be in a state of compression, when the sample is transferred from the channels to the respective containers. In some examples, the transfer may occur through a pressure differential between the channels and the interiors of the containers, when they are placed in fluid communication. For example, a second end of the channel can be placed in fluid communication with the interior of the container. The container can have a vacuum and / or negative pressure in it. The sample can be aspirated into the container when the channel is fluidly communicated with the vacuum container. The device can remain in a compressed state while the sample is transferred to the container. The sample can fill the entire container or part of the container. The entire sample (and / or greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) from the channels can be transferred to the containers. Alternatively, only a portion of the sample channels can be transferred to the containers.
[00143] With reference now to Figure 9C, an example of a device (900) in a separate state will now be described. The base (940) can be separated from the rest of the device (900). The body (920) can be extended or compressed in relation to the support (930). In one example, the extended state can be the natural state, so that when the force is no longer exerted on the body by the user, the body can extend back to the extended state. The channels (922a, 922b) can be attached to the body.
[00144] When the device (900) is in a separate state, the base (940) can be detached from the support (930) of the device. The channels (922a, 922b) can be removed from fluid communication with their respective containers (946a, 946b). When the device (900) is brought into the separation state, a first channel can be brought out of fluid communication with an interior of a first container, and a second channel can be brought out of fluid communication with an interior of a second container. This can occur sequentially or simultaneously. When the channels are removed from the containers, the containers can assume a sealed state to prevent unwanted material from entering the containers. In some embodiments, the containers can be fluid tight after the channels are removed. Optionally, the containers can be gas-tight after removing the channels.
[00145] A user can separate the base (940) from the support (930) to place the device in a separate state to remove the containers inside. In some embodiments, the base can be detached from the support, or vice versa. Separating the base from the support can expose the containers (946a, 946b) that are supported by the base. The containers can be adapted by pressure or otherwise kept inside the base. The containers (946a, 946b) can be removable from the base. As a non-limiting example, removing the containers (946a, 946b) allows them to be placed with other containers in a climate controlled container for transport to an analysis site. Optionally, the containers (946a, 946b) can be removed to allow pretreatment, such as, but not limited to, centrifugation before being sent for processing at an analysis site. Alternatively, the containers (946a, 946b) can remain with the base.
[00146] Figures 10A-10B provide additional views of a sample collection device (1000) in a separate state. When in a separate state, the base (1040) can be separated (partially or completely) from the support (1030) and / or the body (1020) of the device. This allows removal of all containers (1046a and 1046b) through the base end of (1040), previously not exposed externally when the device (1000) was not in a separate state.
[00147] When the device is in a separate state, one or more channels (1022a, 1022b) can be fluidly isolated from one or more containers (1046a, 1046b) housed by the base (1040). The containers can be sealed fluidly from their environment. The containers may contain sample in them, which had been transported through the collection channels, reached a minimum level of filling and was then substantially deposited in the respective containers. The base (1040) can include one or more optical indicators (1046a, 1046b). The optical indicator can show a part of the containers contained therein, such that the device (1000) is not moved to the separate state until a minimum filling level has been reached in the containers. As a non-limiting example, the containers can have an optically transmitting material that can allow a user to view the sample inside the containers outside the base.
[00148] In some embodiments, the base (1040) can include at least a part of the containers. The base may have a hollow interior and walls that surround the hollow interior. The base can have one or more characteristics in a way that can support the containers. The containers can be supplied inside the hollow interior. The walls can surround the container. The base can have an open upper part, through which the containers can be exposed. Containers may or may not be removed via the open top. Collection device with multiple collection channels
[00149] With reference now to Figures 11A-11F, yet another embodiment, as described herein, will now be disclosed. This embodiment provides a body fluid sampling device (1100) for use in collecting a fluid sample that can be combined or otherwise formed on a surface, such as, but not limited to, skin or other target area of an individual. Although this embodiment shows a device body that defines at least two collection channels of different volumes, it should be understood that devices with less or more collection channels are not excluded. Embodiments where the same collection volume is used for one or more of the channels are also not excluded. There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[00150] Figure 11A shows a perspective view of an embodiment of a sampling device for a body fluid (1100) with a distal end (1102) configured to engage a fluid sample on a surface. In this embodiment, the distal end (1102) may have a configuration designed to better surround a droplet or pool of body fluid or sample formed on a surface. Some embodiments, in addition to the desired shape, may also have surface treatments at the distal end (1102), such as, but not limited to, chemical treatments, texturing, surface characteristics, or coatings to stimulate fluid flow to the one or more openings (1104) and (1106) at the distal end (1102) leading to the channels in the device (1100).
[00151] As can be seen in Figure 11A, this embodiment of the sample collection device (1100) has two openings (1104) and (1106) for receiving the fluid sample. It should be understood that some embodiments can have more than two openings at the distal end. Some embodiments may have only one opening at the distal end. Optionally, some embodiments may have additional openings along one side or other surfaces leading out of the distal end (1102) of the device (1100). The openings (1104) and (1106) can have any shape of cross section. In some non-limiting examples, the openings may be circular, elliptical, triangular, quadrangular (for example, square, rectangular, trapezoidal), pentagonal, hexagonal, octagonal, or any other form of cross section. The shape of the cross section can remain the same or it can vary along the length of the body of the collection device. In some cases, the openings may have a cross-sectional area of less than or equal to about 2 mm2, 1.5 mm2, 1 mm2, 0.8 mm2, 2 2 2 ». 0.5 mm, 0.3 mm, or 0.1 mm. Some embodiments have the opening with the same shape. Others may use different shapes for one or more openings.
[00152] The sample filling part (1120), which can be the body of the sample collection device (1100), can be formed of a transparent and / or translucent material, which can allow a user to see if a sample Sample collection channel (s) (see Figure 11B) entered the sample filling part (1120). In some embodiments, the entire sample filling portion (1120) is transparent or translucent. Alternatively, some embodiments may have only all areas over the channel or only selected portions of the channel or sample filler portion (120) being transparent or translucent to allow a user to view the sample fill into the device sample collection (1100). Optionally, the sample filling portion is made of an opaque material, but has an opening or window to allow visualization of the filling level. The device (1100) may further include one or more viewing windows (1112 and 1114) to allow a user to see when a desired fill level has been reached. The viewing window can be formed of a transparent and / or translucent material. Alternatively, the viewing window can be an opening without any material in it. Additional viewing windows can also be used to determine if all of the fluid in the collection channels has been emptied from inside the containers (1146a and 1146b) (see Figure 11B).
[00153] Figure 11A also shows that some support embodiments (1130) may have optical windows (1132 and 1134) that are positioned to show the filling levels of the containers (1146a) and (1146b) to show whether the containers at the base (1140) have been moved to the position to receive the fluid sample. Optionally, the windows (1132) and (1134) can be cutouts that act as guides for the base docking features, in order to define the start and end positions during activation. It should be understood that the base can be configured to contain one or more sample containers. As an example and not a limitation, the entire base (1140) can be removed from the sample collection device before or after filling the sample. The base (1140) can be used as a housing to hold the sample containers during transport and, in such an embodiment, the base (1140), together with the sample containers, would be loaded onto a shipping tray or other support for transportation. Alternatively, some embodiments can remove the sample containers from the base (1140) and then transport the containers without the base (1140) that holds them.
[00154] Figure 11B shows a cross-sectional view along the BB cut lines of the embodiment shown in Figure 11C. Figure 11B shows the channels (1126) and (1128) in the portion (1120). The sample filling portion (1120) can be formed by two or more parts that come together to define the portion (1120). Some may define the channels in a single piece and then have another piece that couples the first piece, to define an opposite or upper wall surface of the channel. In terms of manufacture, this allows a part to have molded or otherwise formed channels within the body and the opposite part engages to act as a cover for the channels or it may also include portions of the channel. The channels (1126) and (1128) can be formed only in the portion (1120), or they can also extend in the support (1130), which has resources to connect with the containers kept in the base (1140) or carrier. Some embodiments can integrally form portions (1120) and (1130) together. The support (1130) can also be configured to retain the adapter channel (1150) which will fluidly connect the channels (1126) and (1128) with the respective containers (1146a) and (1146B).
[00155] Although these embodiments are described here using two channels and two containers, it should be understood that other numbers of channels and containers are not excluded. Some configurations may have more channels than containers, where some channels will couple to the same container. Some embodiments may have more containers than channels, in which case several containers can be operatively coupled to the same channel.
[00156] As seen in Figure 11B, the channels (1126) and (1128) can be of different sizes. This allows different volumes of fluid to be collected in each channel, before being transferred simultaneously to the containers (1146a) and (1146B). Optionally, some embodiments may have channels (1126) and (1128) sized to contain the same volume of fluid. In some embodiments, the fluid flow of the channels (1126) and (1128) is shaped and / or angled so that the openings near the distal end (1102) are closer together than the proximal ends, which can be spaced to align them with the container inlets (1146a) and (1146b). There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[00157] Figure 11B also shows that some embodiments can use needles for the adapter channels (1150) and (1152) in the body (1130), which are in communication with the channels (1126) and (1128). Each needle has a channel to allow fluid to pass through it from the collection channels (1126) and (1128) to the ends of the needles. As can be seen in Figure 11B, the containers (1146a) and (1146B) in the base (1140) are susceptible to slide in relation to the support (1130), as indicated by the arrow (1156). The relative movement between the support (1130) and base (1140) can close the opening (1160). Closing the opening (1160) brings the adapter channels (1150) into the space (1148a) of the container (1146a), until there is fluid communication between the interior of the container (1146a) and the collection channel (1126). At that time, the driving force in the form will then move the fluid in the channel (1126) to the container (1146a).
[00158] As an example and not a limitation, any combination of driving forces can be used to pull the sample into the container. Some embodiments may use vacuum traction in the containers (1146a) to pull the sample into the container. Some may use impulse force from external pressure to move the fluid into the container. Some embodiments can use both. Some may have capillary action and / or gravity. In some embodiments, the driving force (s) used to pull the sample into the channel is different from the driving force (s) used to pull the sample into the container. In some alternative embodiments, the driving force (s) may be the same for each phase. In some embodiments, the driving forces are applied sequentially or over defined periods of time. As a non-limiting example, the driving force to extract samples into the container is not applied until at least one channel has reached a minimum filling level. Optionally, the driving force to pull the sample into the container is not applied until at least the two channels have reached a minimum filling level for said channel. Optionally, the driving force (s) to pull the sample into the container is not applied until all channels have reached a minimum fill level for that channel. In some embodiments, driving forces are applied simultaneously. These features shown can be applicable to any of the embodiments of the present invention.
[00159] With reference now to Figure 11E, an enlarged cross-sectional view of the device (1100) is shown. This embodiment shows that the holder (1130) has a lip portion (1136) dimensioned to extend over the channels of the adapter (1150) and (1152), to an extent sufficient to prevent a user from inserting a finger into the opening ( 1160) and pierce your finger on the needle.
[00160] Furthermore, as shown in Figures 11B and 11E, the present embodiment has at least two channels of the sample collection device (1100). This allows each of the channels (1128) and (1126) to introduce a different material into the sample. As a non-limiting example, if the sample is completely blood, one channel can introduce heparin into the blood, while the other channel introduces ethylene diaminetetraacetic acid (EDTA). Not only do these anticoagulants prevent premature channel clogging during filling, but they also introduce anticoagulants into the blood in preparation for transport in containers (1146a) and (1146B). Optionally, the channel can also be coated with plasma in addition to or in place of anticoagulants. Plasma coating can reduce the flow resistance of the body fluid sample in the channels. Such a coating can be applied in patterns such as, but not limited to, strips, rings or other patterns, along with any other coating to be used in the channels.
[00161] Optionally, there is sufficient amount of anticoagulant in the respective channel such that the fluid sample will contain a desired level of anticoagulant in the fluid after a single passage of the fluid through the channel. In traditional blood vials, the blood sample does not contain anticoagulant until it enters the vial and, once inside the vial, the technician typically tilts and repeatedly taps and / or shakes the vial to allow mixing of anticoagulants in bottles. In the present embodiment, the fluid sample will contain anticoagulant before entering the sample container and will do so without having to tilt or shake the sample collection device several times. In the embodiment disclosed herein, a single pass provides sufficient time and sufficient concentration of additive, such as anticoagulant for the sample fluid. In one embodiment, an EDTA channel has a volume of 54μL coated with 200 mg / ml EDTA; a channel for heparin has a volume of about 22μL coated with 250 units / ml of heparin. In another embodiment, the EDTA channel has a volume of 70μL coated with 300 mg / ml of EDTA; the heparin channel has a volume of about 30μl and is coated with 250 units / ml of heparin. As a non-limiting example, a volume channel of 50 to 70 μl can be coated with EDTA in the range of from about 200 to 300 mg / ml of EDTA. Optionally, a 70 to 100 μl volume channel can be coated with EDTA in the range of from about 300 to 450 mg / ml EDTA. Optionally, a volume channel of between 20 and 30 μl can be coated with heparin in the range from 250 units / ml of heparin. As an example, the material can be coated by solution on the target surface for less than 1 hour and then dried overnight. There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[00162] With reference now to Figure 11G, another additional embodiment will now be described. The embodiment of Figure 11G shows that at a distal end (1202) of the sampling device (1200), instead of having an opening (1204) for each of the channels, the sampling device (1200) merges two or more of the channels in a single channel. The embodiment of Figure11G shows that there is no common channel portion before the division of the common channel in which a plurality of separate channels. As will be described later in Figure 111, optionally there may be a return flow preventive, such as, but not limited to, a vent positioned along the separate channel to reduce the possibility of sampling from one channel to the other channel. during filling and / or extracting the sample from the channels into the sample container.
[00163] As seen in Figure 11H, the use of common flow paths can result in a reduced number of openings on the outside of the sample collection device (1200), which can cause you to align the opening (1204) to engage the body fluid sample. It can also increase the capillary force to pull the body fluid sample into the sample collection device (1200), as it has more capillaries pulling in the same channel into which the body fluid sample enters the collection device.
[00164] With reference now to Figure 111, a cross-sectional view of components selected from a sample collection device will now be described. Fig. 111 shows that the sample collection device can have two channels (1182) and (1184) that have a common portion (1186) leading to an entrance opening in the device. In some embodiments, the common part (1186) is a continuation of one of the channels (1182) or (1184), in terms of size, shape and / or orientation. Optionally, the common part (1186) is not the same size, shape, and / or orientation as any of the channels of (1182, 1184), or any other channel that may be in fluid communication with the common part (1186). Fig. 111 shows that in a non-limiting example, there may be a step in the interface (1188) between the channel (1182) and the channel (1184). This interface (1188) can be configured to ensure the flow in both channels so that both will reach a complete filling. In one embodiment, the interface (1188) is larger in size than the channel (1182) that departs from the interface (1188). Although other sizes were not excluded, this larger interface (1188) can guarantee that sufficient flow will enter the channel (1182), which in the present embodiment, has a smaller diameter and reduced volume in relation to the channel (1184). There may be variations and alternatives to the embodiments described herein and no embodiment should be interpreted to encompass the entire invention.
[00165] Figure 111 also shows that there may be openings (1190) and (1192) that can be used to prevent cross flow between the channels, particularly when the sample is transferred to the sample containers. In one embodiment, the openings (1190) and (1192) are open at all times. In another embodiment, the openings (1190) and (1192) can be opened only at certain times, such as, but not limited to, after the channels (1182) and (1184) are filled or substantially filled. Some embodiments may use a dissolvable material that covers the openings (1190) and (1192) until they are in contact with the fluid sample. Optionally, some embodiments may use sliding covers that cover one or more of the openings (1190) and (1192) so that they are only opened at times selected by the user. In one embodiment, the covers are attached to the sample containers so that the movement of the containers to move for fluid communication with the channels will also open one or more openings (1190) and (1192) to reduce the risk of cross flow between the channels. Optionally, other cross-flow anti-flow mechanisms, such as valves, locks or plugs can also be used to prevent fluid transfer between channels (1190) and (1192).
[00166] Figure 111 also shows that there may be devices against leakage (1194) positioned along the adapters (1150) and (1152). In this embodiment, the leakage devices (1194) are fried which can be moved in a sliding way from a first position, in which they prevent the sample from leaking out of the adapters (1150) and (1152), to a second position, which allow adapters to supply fluid to sample containers. In a non-limiting example, the leakage devices (1194) will slide when they are engaged with the sample containers or the compartment containing the sample containers. The movement of the sample containers or the housing, in this non-limiting example, shows that the movement of these elements will also cause the movement of the devices against leakage (1194). Integrated fabric penetrating element
[00167] With reference now to Figure 11J, yet another embodiment of a sample collection device will now be described. This sample collection device (1210) comprises characteristics similar to that shown in Figure 11G, except that it also includes a penetrating fabric element (1212) that is mounted on the sample collection device (1210). A drive mechanism (1214), such as, but not limited to, a spring actuator can be used to launch the penetrating fabric element. Figure 11J shows the drive mechanism (1214) in a resting state, which can be a spring that can be compressed to launch a penetrating fabric element (1212) towards the target fabric. The tissue penetrating element (1212) can be housed within a housing (1216) (shown in dashed lines). In one embodiment, the housing (1216) comprises a portion that can be pulled back, perforated, released or otherwise opened to allow the tissue-penetrating element (1212) to leave the housing, but also to maintain the sterility of the element penetrating tissue (1212) before use. In some embodiments, the portion may be a sheet, a lid, a polymer layer, or the like. There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[00168] In one embodiment, the path of the tissue penetrating element (1212) can be controlled both in the "normal" direction (i.e., the forward direction of the tissue penetrating element) and in the "orthogonal" direction "(that is, perpendicular to the main motion vector) of the trajectory. Some configurations may not have a hard stop or stop at the deepest point of penetration (ie, return point), which is the main cause for spontaneous pain. Some embodiments may use a cushion, cam track, or other non-stop mechanism to prevent pain associated with the shock wave of sudden braking. Such a shock wave is harmful even if the tissue penetrating element successfully avoids hitting nerves near the wound site, as the shock wave can activate these nerves even if direct contact has been avoided. Optionally, some embodiments may have the tissue penetrating element following an undeviated path, to avoid a rough wound channel (residual pain). This can be achieved in some embodiments through tighter tolerance in any tissue penetration guide path used with tissue penetration element or pin associated with the tissue penetration element. This can be an untapped path when penetrating the tissue. Optionally, this can be an untapped path for the element to penetrate the fabric, both outside the fabric and inside the fabric. This can reduce the overall "oscillation" movement of the penetrating tissue element which can cause residual pain, long-lasting trauma, and scarring.
[00169] Some configurations may have a controlled exit speed to avoid slow and delayed wound closure after bleeding. As a non-limiting example, the controlled exit speed of the tissue penetrating member can be controlled by mechanical means, such as, but not limited to, cams or higher friction materials.
[00170] Some embodiments may also include skip mechanisms to prevent unwanted re-launches that can be associated with an uncontrolled tissue penetrating member that protrudes into the wound tissue after initial creation. Some embodiments here may have "parking" or locking mechanisms that will engage the tissue penetrating element or its attachments to prevent reentering the fabric once it has been retracted out of the fabric or some other desired distance.
[00171] The suddenness with which the lancet comes to a stop at the skin at maximum depth, before starting its movement of exit and return to its initial position, is an inherent issue of this project. With the lancet at its deepest point of penetration, the greatest amount of force is applied to the skin. The drive mechanism simply bounces off the end of the device as a ball hits and returns from the floor. The lancet, coming to an abrupt stop at the end point of its entry movement, sends a shock wave through the skin, causing many pain receptors in the vicinity of the lancet to fire, even if they are not directly hit. This amplifies spontaneous pain substantially.
[00172] As mentioned, instead of simple spring-loaded penetrating fabric members, some embodiments may use mechanical cam actuation. Devices with cam actuation design can minimize "hard stop" of the tissue penetrating member. A cam mechanism is generally spring-loaded and generally offers better guided performance. The path of the tissue penetrating member is rigidly controlled through a guided path of the tissue penetrating member through a pin mounted on the cam. The cam mechanism allows a predetermined speed profile with a smoother return and distinct speed control for the exit path of the tissue penetrating member. This mechanism also effectively prevents a lancet from jumping back into the skin when the mechanism reaches its end point of movement. In addition, the mechanical oscillation (or deviation / oscillation) of the boom path in both directions is reduced when it is fired into the air. Some embodiments of the invention can also minimize any mechanical oscillation of the drive mechanism (for example, due to irregular or rough grooves in the cam) to avoid transferring oscillation from such a drive mechanism directly into the fabric due to its "profile" of forced movement. "
[00173] Optionally, some embodiments can use electronic actuation through an electronically controlled drive mechanism. This technology uses a miniaturized electric motor (for example, a voice coil, solenoid) coupled with a very precise position sensor, moving the tissue penetrating element in and out of the skin with precisely controlled speed and movement. After rapid entry, the device decelerates the tissue penetrating element to a pre-set depth to return smoothly, without deviations and relatively slowly. This allows the wound to close quickly and prevents long-term trauma. With this device, the force necessary to penetrate the lancet into the skin is controlled as the penetrating element of the tissue advances. The advantage of strictly controlling the tissue penetration profile of the penetrating element is a painless reproducible lancet that produces a sufficient and consistent blood sample for the test.
[00174] In terms of local creation of the puncture for blood sample extraction, it may be desirable to choose the appropriate puncture site on one of the patient's fingers (annular or middle) on his non-dominant hand. The puncture sites may be on the sides of the fingertips. In a non-limiting example, it may be desirable to hold the hand warm strip against the patient's selected finger for 15 seconds. This will increase the blood flow to the finger. Clean the side tip of the selected finger with an alcohol swab, not forgetting to clean the selected puncture site. Wait until the skin is completely dry. Do not dry with gauze or blow air at the fingertip.
[00175] After a puncture has been formed, hold the finger down, below the patient's waist, in order to allow blood to flow. Massage your finger lightly from base to tip until a drop of blood forms. Carefully fill the blood collection device by touching the tip of the device to the blood cord on the finger. Check that the device is completely full. Once the blood collection device is full, press the bleeding area of the finger against the gauze on the table. Transfer the blood sample to the collection containers. Place a plaster on the finger. Place the containers with the sample in a transport box inside the refrigerator. Dispose of all supplies in the biohazard container. All supplies are used only once.
[00176] If enough blood is not obtained from the first hole, carefully place the blood collection device on the table surface, ensuring that the device remains horizontal. Place a plaster on the finger that has been pierced. Choose the appropriate puncture site on a different finger on the same side as the patient. If the ring finger was first pierced, choose a new puncture site on the middle finger, and vice versa. Hold the warmest strip of the hand against the patient's selected finger for 60 seconds. This will increase the blood flow to the finger. These techniques for blood collection, using a sample collection device, like any of the here can allow for the collection of sufficient capillary blood sample for use in clinical laboratory testing (CLIA) installation and / or certification standards.
[00177] With reference now to Figure 11K, yet another embodiment of a sample collection device (1220) will now be described. In this embodiment, the tissue penetrating member (1222) can be mounted at an angle to the sample collection device (1220). This angular configuration allows the tissue penetrating member to create a wound at a location that aligns with the sample acquisition opening (s) (1103) and (1105). Although a standard spring-loaded actuator is shown as the actuation mechanism (1224) for the tissue penetrating member (1222), it should be understood that the cam and / or electrically actuated systems can also be used in place of or in combination with the spring launcher. When the drive mechanism (1224) is a spring, the spring can be compressed to move the tissue penetrating member (1222) to a release and release position to penetrate the target tissue. Figure 11K shows the tissue penetrating member (1222) at rest. Although the figures show a spring as a trigger mechanism (1224), it should be understood that another trigger mechanism suitable for use in launching a tissue penetrating limb to create a curable wound in a patient is not excluded. There may be variations and alternatives to the embodiments described herein and no single embodiment should be construed as covering the entire invention.
[00178] A housing (1226), similar to that described for the housing (1216), can be formed around the tissue penetrating member (1222). Although Figure 11K shows two tissue penetrating members (1222) mounted on the sample collection device, it should be understood that devices with more or less tissue penetrating members are not excluded. For example, some embodiments may have only one penetrating fabric element (1222) mounted with the sample collection device (1220). There may be variations and alternatives to the embodiments described herein and no single embodiment should be interpreted to encompass the entire invention.
[00179] With reference now to Figure 11L, another embodiment of a sample collection device (1230) will now be described. This embodiment shows that the tissue penetrating member (1232) is contained within the sample collection device (1230) and as can be seen in Figure 11L, it is actually aligned coaxially with the central axis of the device sample collection. This positions the tissue penetrating member (1232) to extend outward from the sample collection device (1230) at a location close to where the openings (1103) and (1105) are positioned on the sample collection device (1230) ). It is clear that devices that have more or less openings are not excluded and the embodiment of Figure 11L is exemplary and not limiting. Figure 11L shows that in an embodiment of the sample collection device, a trigger button (1234) can be mounted on the sample collection device (1230). Optionally, some embodiments may have the function of shaped front end (1236) acting as the trigger button, in which when pressing the fabric against the front end (1236) at a certain depth and / or with certain pressure the penetrating element in fabric will be triggered.
[00180] Once fired, the tissue penetrating element (1232) moves as indicated by the arrow (1233). In some embodiments, the tissue penetrating member (1232) is fully contained within the sample collection device (1230) prior to actuation. Some embodiments may have a visual indicator (1235) on the device (1230) to help guide the user on where the tissue penetrating member (1232) will exit the device and where approximately the wound will be formed.
[00181] In this non-limiting example, the entire device (1230) can be in a sterile pouch or package that is only opened before the device (1230) is used. In this way, sterile conditions are maintained for the tissue penetrating element and the collection device before use. This external sterile pouch or packaging is also applicable to any of the other embodiments of the present invention. Figure 11L also shows a shaped front end (1236) (shown dashed) that can be formed integrally or separately connected to the sample collection device (1230). This shaped front end (1236) can provide suction to extract liquid from the sample in the sample collection device (1230). Optionally, the shaped front end (1236) can be used to stretch the target tissue and / or to force it into the shaped front end and apply pressure to increase the production of wound sample fluid formed by the tissue penetrating element (1232). It should be understood that any of the embodiments of this invention can be adapted to have a shaped front end (1236). Optionally, the shaped front end may have hydrophobic areas selected to direct the sample fluid towards one or more collection areas on the front end. Optionally, the shaped front end may have hydrophilic areas selected to direct the sample fluid towards one or more collection areas on the front end.
[00182] With reference now to Figure 11M, yet another embodiment of a sample collection device will now be described. This embodiment is similar to that of Figure 11L, except that instead of a single penetrating member of tissue, such as a lancet, the embodiment of Figure 11L uses a plurality of penetrating members of tissue (1242). In one embodiment, these tissue-penetrating members are microneedles (1242) that are small in diameter, compared to traditional lancets. A plurality of microneedles (1242) can be triggered simultaneously for a device (1240) and create multiple wound sites in the tissue. The spacing of the microneedles (1242) can result in more capillary loops being punctured and more channels being available for blood to reach the tissue surface. This also allows for a more "square" penetration profile, compared to a lancet, which has a sharp tip and a tapered profile. This can allow the microneedles (1242) to reach more capillary loops over a larger area without penetrating too deeply into deeper layers of tissue that are more densely populated with nerve endings.
[00183] With reference now to Figures 11N and 11O, another additional embodiment of the sample collection device will now be described. In the embodiment shown in these figures, the sample collection device (1100) can be mounted at an angle with a dedicated wound creation device (1250) that has a tissue penetrating member (1252) configured to extend outwardly from the device (1250). The sample collection device (1100), which can optionally be configured to have a shaped front end (1236) (with or without an opening to accommodate the tissue penetrating member (1252)), can be removably mounted to the device of wound creation (1250). Optionally, the sample collection device (1100) can be mounted flat on the device (1250). Optionally, there may be a cutout formed on the pressure fitting device (1250) to secure the sample collection device (1100). It should be understood that other techniques for the removable assembly of the sample collection device (1100) are not excluded. This dissociation between the collection device and the wound creation device allows the use of a more sophisticated, possibly non-disposable, wound creation device (1250) that can create a wound creation experience in a more controlled and with reduced pain.
[00184] Figure 11O shows that the sample collection device (1100) can be aligned to be more or less horizontal to be neutral in relation to the effects of gravity on sample collection. Other device mounting configurations (1100) for the wound creation device (1250) are not excluded.
[00185] With reference now to Figures 11P to 11R, yet other embodiments of various sample collection devices will now be described. Figure 11P shows a sample collection device (1240), where a shaped front end (1236) can be used with the device (1240). This profiled front end (1236) is similar to that described above. A vacuum source (1270) can be used to assist in collecting the body fluid sample into the device (1240). The vacuum source (1270) can be connected to the device body (1240) and / or the shaped front part (1236). It should be understood that any of the embodiments described in this specification can be adapted for use with an auxiliary sample acquisition device, such as, but not limited to, a vacuum source (1270).
[00186] Figure 11Q shows yet another embodiment of a sample collection device. This embodiment uses a pipette system that has a sample fluid collecting tip (1280). The tip may include a coaxially mounted tissue penetrating member (1282). Optionally, a side mount or penetrating tissue member at an angle (1284) is shown to create the wound at the target location. The tip pipette system (1280) can apply a vacuum to draw the sample fluid from the patient. Optionally, a profiled front end (1236) can be used with the tip (1280) to assist in stretching the skin or remodeling the tissue at the target location.
[00187] Figure 11R shows that some embodiments can use an addition mechanism (1291) connected to the diaphragm to create a vacuum for collecting the blood sample. This connection allows the diaphragm to create a vacuum in the return path of the tissue penetrating member (1292) from the target site. In one embodiment, the tissue penetrating members (1292) are microneedles. The activation of the tissue penetrating member, as indicated by the arrows (1294) launches the tissue penetrating member (1292) and, in the return path, creates a vacuum, due to the movement of the diaphragm connected to the movement of the tissue penetrating member (1292). One or more containers (1296) can be coupled to hold the fluid collected by the device (1290). Some embodiments may have only one container (1296). Some embodiments may have a set of containers (1296). Some embodiments may have several sets of containers (1296). Some embodiments can be mounted externally on the device (1290). Some embodiments can be mounted internally on the device (1290). There may be variations and alternatives to the embodiments described herein and no embodiment should be interpreted to encompass the entire invention. Vertical flow restrictors.
[00188] Figure 11E also shows more clearly that there are sleeves (1170) around the adapter (1150) and (1152). Although only shown in Figures 11A-11F, it should be understood that the sleeves, with or without ventilation openings, can be configured for use with any of the embodiments contemplated herein. As can be seen in the embodiment of Figure 11E, the channels can be defined by needles. These sleeves (1170) prevent premature flow of the fluid sample out of the adapter channels (1150) and (1152) before the containers (1146a) and (1146B) wrap the needles. Due to the low volumes of fluid sample to be acquired, preventing premature flow reduces the amount of fluid loss associated with the transfer of fluid from the channels to the containers. In one embodiment, the sleeves (1170) that can minimize fluid loss by providing a sleeve that is liquid-tight, but not air-tight. If the sleeve is airtight it can prevent the capillary action of the channels from working properly. Optionally, some embodiments can locate openings near the base of the needle, away from the tip, such that the sleeve can contain the sample in places away from the ventilation openings.
[00189] Figure 1 shows that, in an exemplary embodiment, the sleeve 1170 is configured to have an opening through the sleeve 1180. This provides a better embodiment along traditional sleeves that are typically mounted freely on a needle. Due to the loose fit on traditional sleeves, there is sleeve space at the tip and in the space between the side wall of the needle and the sleeve within which the fluid sample can accumulate. Although a sleeve of this design can help prevent further fluid loss by limiting the loss of a defined amount, compared to a needle without a sleeve, which can lose fluid continuously, fluid accumulates in the sleeve area along the side wall. from the tip and is still lost and not charged by the 1146a or 1146B containers. The sleeve 1170 may also include a narrowed area 1176 to facilitate coupling the sleeve against the device that provides fluid communication with channels 1126 and 1128, such as, but not limited to, the needle, probe, tube, channel or other channel. adapter 1150. It should also be understood that some device embodiments, as shown in Figure 11, may be sleeveless 1170, but instead use fries from 1194 or the like. Optionally, some embodiments can be without any flow restriction products.
[00190] In the embodiment of Figure 1, if, the opening 1180 is dimensioned based on calculations that are sufficient to withstand the fluid pressure associated with the flow from the capillary action of the filling channels in the sample 1120. A forces portion allows the opening for 1180 to be present to vent air from the channel, but also prevent the fluid coming out of the sleeve until containers 1146a and 1146b are pushed to wrap around the adapter channels 1150 and 1152. Due to the effect of ventilation created by opening 1180, the side wall and other areas of the sleeve can be made much more firmly to engage the needle than in traditional sleeves. This reduces the gap between the needle and the sleeve and therefore minimizes the amount of fluid that can be lost compared to gloves without a vent hole that have a much larger gap due to the looseness of the fit. In addition, the opening 1180 can also be dimensioned fluidly once it reaches the opening, which provides enough resistance to flow out of the channel or needle, it is also interrupted, so that the loss of fluid in any space between the sleeve and the needle tip.
[00191] The calculations for sizing the opening are as shown in Figure 12. The desire is to balance the forces in such a way that there is not enough leakage prevention force associated with the hydrophobic material that defines the opening to contain fluid flow sample out of the sleeve. In Figure 12, the side walls of the sleeve 1170 may be in direct contact with the needle or in some embodiments, there may be an opening along the side wall with the sleeve. In one embodiment, sleeve 1170 includes a hydrophobic material, such as, but not limited to, thermoplastic elastomer (TPE), butyl rubber, silicone, or other hydrophobic material. In one embodiment, the thickness of the sleeve will also determine the length of the side walls of the opening or the openings 1180 in the sleeve 1170.
[00192] Opening 1180 may be located at one or more points along the sleeve of 1170. Some may have as shown in Figure 12. Alternatively, some embodiments may have opening 1180 in the side wall of the sleeve. Other locations are not excluded. Optionally, the sleeve 1170 can have multiple openings through the sleeve, but configured in such a way that the fluid does not leave the sleeve and the resistance of the openings is sufficient to prevent the outlet of the additional channel until the containers 1146a or 1146B are engaged and in fluid communication with the channels.
[00193] Regarding the way the 1100 device is used to collect a sample, in one technique, the 1100 sample collection device is performed to wrap the target body fluid and is held in place until a desired filling level is Reached. During this time, the 1100 device can be held in a horizontal position to minimize the gravitational force that has to be overcome if the 1100 device was carried out more vertically. After a filling level is reached, the device 1100 can be disengaged or from the destination fluid and then the containers 1146a and 1146B contracted to extract the liquid collected in the containers. Optionally, the device 1100 can be left in contact with the target fluid and the containers involved in fluid contact with the channels so that the filling will draw fluid in the channel and, perhaps, also any additional sample fluid that remains in place target. This can ensure that sufficient body fluid is drawn into the containers.
[00194] After filling the 1146a and 1146B containers, they can be prepared for dispatch. Optionally, they can be sent for pre-treatment before being dispatched. Some embodiments of containers 1146a and 1146B include a material in the container of a density such that, after a pretreatment such as centrifugation, the material, due to its selected density, will separate a portion of the centrifuged sample from another portion of the sample centrifuged in the same container.
[00195] The 1146a container or 1146B may have a vacuum and / or negative pressure in it. The sample can be dragged into the container when the channel is placed in fluid communication with the vacu container. Optionally, the container can take the form of a test tube type device in the form of those sold under the trademark "Vacutainer" by Becton-Dickinson Company of East Rutherford, NJ. The device can remain in a compressed state with the reduction of the base differential 1140 1160 while the sample is being transferred to the container. The sample can fill the entire container or part of the container. The entire sample (and / or greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) from the channels can be transferred to the containers. Alternatively, only a portion of the sample from the channels can be transferred to the containers.
[00196] In one embodiment, as described herein, a two-phase filling of the sample fluid into the 1100 sample collection device allows i) calibrated collection of the fluid sample to ensure that a sufficient amount is obtained with a collection channel that is treated to prevent premature clotting and then ii) an efficient way of transferring a high percentage of the fluid sample into the container. This low filling loss of pre-fill channels to measure a minimum amount of fluid sample within the 1146 container provides several advantages, especially when dealing with the collection of small volumes of fluid sample. Pre-filling the channels to a desired level ensures sufficient volume is present in the container to perform the desired test on the fluid sample.
[00197] In another embodiment, as described herein, the entire device, including the sample filling portion 1120, support 1130, and base 1140 are entirely transparent or translucent to allow viewing of the components therein. Optionally, only one of the body 1120, supports 1130, 1140 and base are completely transparent or translucent. Optionally, select only parts of the sample filling portion 1120, support 1130, 1140 or base are transparent or translucent. The user can then more accurately determine when to perform various procedures based on the progression of fluid filling of the sample and engagement of the containers into the channels in the sample filling part 1120. Air bubbles in the collection channel may be visible during the filling and if they are seen, a user can adjust the position of the 1100 sample collection device to best fit the target sample fluid to minimize air being drawn into the channels. It will also let the user know when to separate or disengage parts as a base or 1140 holder container when filling is complete.
[00198] It should be understood that other methods can be used to prevent sample flow out from adapter channels 1150 and 1152, if the device is maintained at a non-horizontal angle such as, but not limited to, downwards. a vertical shape. In one embodiment, an 1194 frit can be used with needles with a central hole that is used as the 1150 and 1152 adapter channels. The fries can be in the body of the sample collection device or in the collection vessels. In some embodiments, the fries are composed of a material such as, but not limited to, PTFE. Optionally, some embodiments may use tape / adhesive over the needles that are acting as the adapter channels 1150 and 1152. In one embodiment, the adhesive tape and / or can be used to cover the needle openings to prevent needle premature sample discharge. Optionally, some embodiments may have adapter channels 1150 and 1152 with a hydrophobic surface to prevent controlled outlet from the openings of the adapter channels leading to the sample containers. In some embodiments, adapter channels 1150 and 1152 are needles with hydrophobic material only on the interior surfaces near an outlet. Optionally, the hydrophobic material is only on the outer needle surfaces near an outlet. Optionally, the hydrophobic material is on the inner and outer surfaces of the needle. Optionally, another method of preventing downward flow is to increase the surface area of the capillaries by varying the cross section. By way of non-limiting example, some embodiments may introduce tooth- or finger-like structures into the capillary in the increased surface area of the capillary cross section. Optionally, some embodiments may include fins facing and / or against the flow of fluid within the capillary at the surface increase in order the cross section of the capillary. There may be variations and alternatives to the embodiments described herein and that the only embodiment should not be interpreted in such a way as to cover the entire invention. A sample of multiple channel collector location
[00199] With reference now to Figures 13A-13B, yet another embodiment, as described herein, will now be described. Figure 13A shows a top-down view of a sample filling portion 1320 with a single collection location (1322), such as, but not limited to, a set where two channels 1324 and 1326 meet to extract the liquid for away from the single collection site (1322). Optionally, some embodiments may use a Y-split channel configuration in which only a single channel takes the distance from the collection site (1322) and then splits into channels 1324 and 1326, after having been a single common channel that departs from the collection location (1322). The members providing fluid communication with channels 1324 and 1326, such as, but not limited to, a needle, probe, tube, channel, hollow elongate element, or other structure, can be coupled to one end of the sample filling portion 1320 .
[00200] Figure 13B shows a cross-sectional side view, in which the collection site (1322) is shown and in fluid communication with the 1326 channel, which in turn is in fluid communication with an adapter channel. (1352), such as, but not limited to, a fluid communication member. In some embodiments, the fluid communication member may have sufficient rigidity and a tip sufficiently penetrating to pierce a septum, plug, or other structure of the container. Some may have the adapter channel (1352), 1150, or the like, to be a non-perforating structure so as not to leave a non-sealing hole in the septum, a plug, or other structure of the container.
[00201] As can be seen in Figure 13B, the sample fluid can be applied or dropped at the collection site (1322), as indicated by D. drop Optionally, some can be applied directly or directly in contact with the collection site (1322) to apply the fluid sample. Although the embodiments shown here are only a single sampling site (1322) to use, it should be understood that other embodiments in which several pairs of channels for a common sampling point are envisaged. As a non-limiting example, an embodiment of a collection device may have two collection sites (1322), each with its own set of channels that departs from its respective collection location. Some embodiments may combine channels from the common collection points shown in Figures 13A-B, with channels that are separated as shown in Figures 1 to 1-se. Other combinations of structure common collection location with other structures with separate channels are not excluded.
[00202] Figure 13B also shows that this embodiment may include one or more tissue penetrating members 1327 configured to extend outwardly from the collection site (1322). In one embodiment, this allows the user to place the target tissue, simultaneously, by collecting (1322) and locating the wound breeding site for the acquisition of fluid samples. Optionally, a 1323 trigger can be positioned to launch the penetrating tissue member. Optionally, the trigger is built into an interface for the device's tissue to allow the device to launch when the target tissue is brought into contact and / or when sufficient contact pressure or is in place. This overlap of these two locations allows simplified protocol for users to follow for successful sample acquisition. The 1327 tissue penetration member (s) can be triggered by one or more triggering techniques, such as, but not limited to, the spring spring, cam spring, electronically actuated, or single or multiple combinations of materials. It should be understood that other methods, such as assisting, but not limited to vacuum sources, tissue stretching devices, coupling tissue nose pieces, or the like, can be used alone or in combination with any of the above to improve the acquisition of samples.
[00203] With reference now to Figure 13C, yet another embodiment of a sample collection device will now be described. This embodiment shows a 1400 cartridge with a sample collection device 1402 integrated therein. There is a collection site for (1322) and one or more sample openings 1325and 1329 where sample collection at the site (1322) can then be accessed, such as, but not limited to, pipette tip handling (not shown) . The sample from drop D will travel along path 1326, as indicated by the arrow in the direction of openings 1325 and 1329, where the sample in the opening and any of the paths 1324 and / or 1326 leading to their respective openings 1325 and 1329 are designed for pipette P. As indicated by the arrows P, near the pipette, pipette P is movable on at least one axis to allow the transport of sample fluid to the desired location (s). In this embodiment, the 1400 cartridge may have a plurality of containers holding 1410 for reagents, washing fluids, mixing area, incubation areas, or the like. Optionally, some embodiments of the 1400 cartridge cannot include any capacity containers or, optionally, only one or two types of support containers. Optionally, in some embodiments, the capacity containers can be pipette tips. Optionally, in some embodiments, the capacity containers are pipette tips that are treated to contain reagent (s) on the tip surface (typically the interior tip surface, although other surfaces are not excluded). Optionally, some embodiments of the 1400 cartridge may include only the 1402 sample collection device without a tissue penetrating member or vice versa.
[00204] With reference now to Figure 13D, a side cross-sectional view of the embodiment of Figure 13C is shown. Optionally, a 1327 member tissue penetrant can be included for use with creating the wound for the fluid sample to be collected at the site (1322).
[00205] Figure 14 shows that the sample filling portion 1320 can be joined with the support 1330 and (1340) to form the sample collection device of (1300). There may be a 1312 viewing window to see if the sample fluid has reached a desired fill level. A component of exerting force, such as an elastic spring 1356 or may be included. The channel holder can keep the channel affixed to the support. In one embodiment, the support can prevent the channel from sliding in relation to the support. You can use a pressure fitting, mechanical, adhesive, or other fixation technique to attach to the channel. The support can optionally provide a support on which a force component, such as a spring, can rest.
[00206] In one example, the coupling assemblies can include a spring 1356, which can exert a force so that the base is (1340) in an extended state, when the spring is in its natural state. When the base is in its extended state, a space can be provided between the containers (1346a), (1346b) and the coupling assemblies. In some cases, when the base is (1340) in its extended state, the second ends of the channels may or may not contact the container lids. The second ends of the fluid communication members (1352) may be in a position where they are not in communication with the interiors of the containers.
[00207] Bringing the support 1330 and the base of (1340) together will bring the channels 1324 and 1326 in fluid communication with the containers (1346a) and (1346b) when the members 1,352 penetrate through the lid on the containers and thus draw the fluid sample in the containers (1346a) and (1346b).
[00208] The container (1346a) or (1346b) can have a vacuum and / or negative pressure in it. The sample can be dragged into the container when the channel is placed in fluid communication with the vacu container. The device can remain in a compressed state with the base (1340) positioned so that the containers are in fluid communication with channels 1326 and 1328, when the sample fluid is being transferred to the containers. The sample can fill the entire container or part of the container. The entire sample (and / or greater than 90%, 95%, 97%, 98%, 99%, 99.5% or 99.9% of the sample) from the channels can be transferred to the containers. Alternatively, only a portion of the sample from the channels can be transferred to the containers.
[00209] As seen in Figure 15, in one embodiment, as described herein, a two-phase filling of the sample fluid into the sample collection device (1300) allows i) calibrated collection of the sample of fluid for ensuring that a sufficient amount is obtained under a collection channel that is treated to prevent premature clotting and then ii) an efficient way of transferring a high percentage of the fluid sample into the container. This low-loss container fill pre-filling the channels to measure a minimum amount of sample fluid into the container (1346) provides several advantages, particularly when dealing with collecting small volumes of fluid sample. Pre-filling the channels to a desired level ensures sufficient volume is present in the container to perform the desired test on the fluid sample.
[00210] With reference now to Figures 16 and 17, still other embodiments will now be described. Figure 16 shows a blood collection device with a secondary collection area (1300) 1324 around the collection site (1322). The secondary collection area 1324 can be used to direct any overflow, spilled, or mis-sample of fluid directed to the collection site (1322).
[00211] Figure 17 further shows that the containers (1346a) and (1346b) can each have an identifier associated with the containers (1346a) and (1346b). Figure 17 shows that in a non-limiting example, the identifier (1600) and (1602) can be at least one of: a bar code (for example, 1-D, 2-D or 3-D), a quick response (QR) of code, image, shape, word, number, alphanumeric sequence, color, or any combination thereof, or any type of visual identifier. Others may use identifiers that are not in the visible spectrum. Others can use RFID tags, RF identifiers, IR tag emitters, or other markers that do not depend on identification through signals sent across the visual spectrum.
[00212] Identifiers (1600) and (1602) can be used to identify the sample and / or sample types in a sample collection device. There can be one or more identifiers per container. Some may also use identifiers on container holders. Identifiers can identify the sampling device, one or more individual containers within the device, or components of the device. In some cases, the sample collection device, a portion of the sample collection device, and / or the containers can be transported. In one example, the sample collection device, the portion of the sample collection device can be transported through a delivery service, or any other service described here elsewhere. The sample can be delivered to perform one or more on the test sample.
[00213] The identity of the sample and / or the identity of the person who provided the sample can be monitored. Information associated with the individual or individuals (for example, name, contact information, social security number, date of birth, insurance information, billing information, medical history) and other information from which the sample was provided may be included. In some cases, the type of sample (for example, whole blood, plasma, urine, etc.) can be traced. The types of reagents that the sample will have found (for example, anticoagulants, labels, etc.) can also be traced. Additional information about the collection of samples, such as date and / or time of collection, circumstances in which sample was taken, types of tests to be performed on the sample, insurance information, medical records information, or any other type of information may be considered.
[00214] identifiers can help in tracking such information. Identifiers can be associated with such information. Such information can be stored outside the sample collection device, on the sample collection device, or any combination thereof. In some cases, information can be stored on one or more external devices, such as computers, servers, databases, or any other device that has a memory. In some cases, the information can be stored in a cloud computing infrastructure. One or more resources that store the information can be distributed through the cloud. In some cases, a point-to-point infrastructure can be provided. The information can be stored in the identifier itself, or it can be associated with the identifier of other places, or any combination of them.
[00215] An identifier can provide unique identification, or it can provide a high probability of providing unique identification. In some cases, the identifier may have a visible component. The identifier can be optically detectable. In some cases, the identifier may be discernible using visible light. In some examples, the identifier may be a bar code (for example, 1-D, 2-D or 3-D), a quick response (QR) code, image, shape, word, number, alphanumeric string, color , or any combination thereof, or any type of visual identifier.
[00216] In other embodiments, the identifier can be optically detectable by means of any other type of radiation. For example, the identifier can be detectable via infrared, ultraviolet, or any other type of wavelength of the electromagnetic spectrum. The identifier can use luminescence, such as fluorescence, chemiluminescence, bioluminescence, or any other type of optical emission. In some cases, the identifier may be a radio transmitter and / or receiver. The identifier can be a radio frequency identification (RFID) tag. The identifier can be any type of wireless transmitter and / or receiver. The identifier can send one or more electrical signals. In some cases, GPS or other location-related signals can be used with the identifier.
[00217] An identifier can include an audio component, or an acoustic component. The identifier can make a sound that can be perceived to uniquely identify the component.
[00218] The identifier can be detectable through an optical detection device. For example, a barcode scanner may be able to read the identifier. In another example, a camera (for example, for still or video images) or another image capture device may be able to capture an image of the identifier and analyze the image to determine the identification.
[00219] Figures 16 and 17 show examples of identifiers provided for use with a (1300) sample collection device according to an embodiment described here. In one example, a sample collection device may include a base (1340) which can support and / or contain one or more containers (1346a), (1346b). Sample can be supplied to the sample collection device. The sample can be supplied to the sample collection device via an inlet (1322). The sample can travel to one or more containers (1346a), (1346b) inside the device.
[00220] One or more identifier (1600), (1602) can be provided in the sample collection device. In some embodiments, the identifiers can be positioned on a base (1340) of the sample collection device. The identifiers can be positioned on a bottom surface of the base, the side surface of the base, or any other part of the base. In one example, the base may have a flat bottom surface. The identifiers can be on the bottom flat surface of the base. One or more indentation may be provided at the base. The identifier can be located inside the recess. The notches can be on the bottom surface or side of the base. In some embodiments, the base may include one or more protrusions. The identifier can be located on the ledge. In some cases, the identifiers can be provided on an outer surface of the base. The identifiers can alternatively be positioned on an interior surface of the base. The identifiers can be detected from outside the sample collection device.
[00221] In some embodiments, identifiers can be provided on the containers (1346a), (1346b). The identifiers can be of an outer surface of the containers or an inner surface of the containers. The identifiers can be detected on the outside of the containers. In some embodiments, the identifiers can be provided on a bottom surface of the containers.
[00222] In one example, the base may include an optically transmissive portion. The optically transmissive portion may be at the bottom of the base or on one side of the base. For example, a transparent or translucent window can be provided. In another example, the optically transmissive portion may be a hole without the need for a window. The optically transmissive portion may allow an interior portion of the base to be visible. The identifiers may be provided on an outer surface of the base over the optically transmissive portion, an inner surface of the base, but may be visible through the optically transmissive portion, or on an outer or inner surface of the container, but may be visible through the optically portion transmissive. In some cases, the identifier can be provided on an interior surface of the container, but the container can be optically transmissive so that the identifier is visible through the container and / or the optically transmissive portion.
[00223] The identifier can be a QR code or other optical identifier that can be optically visible from the outside of the sample collection device. A QR code can be visible through an optical window or hole at the bottom of the base of the sample collection device. The QR code can be provided on the base of the sample collection device or on a part of the container visible through the base. An image capture device, such as a camera or scanner, can be provided externally to the sample collection device, and may be able to scan the QR code.
[00224] The single or a plurality of QR codes or other identifiers can be provided in a sample collection device. In some cases, each container may have at least one identifier, such as a QR code associated with it. In one example, at least one window can be provided on a per-container basis, and each window can allow a user to view a QR code or other identifier. For example, two containers (1346a), (1346b) can be housed within a base of (1340), each of which has an associated identifier (1600), (1602) discernible from the outside of the sample collection device .
[00225] The base (1340) can be separable from the support 1330 or other portions of the sample collection device. The identifier (s) can be separated from the rest of the sample collection device, along with the base.
[00226] In some embodiments, identifiers can be provided with containers housed by the base. Separating the base from the rest of the sample collection device can cause the containers to be separated from the rest of the sample collection device. The containers can remain inside the base, or can be removed from the base. The identifiers can remain with the containers, even if they are removed from the base. Alternatively, the identifiers can remain with the base even if the containers are removed. In some cases, both the base and containers may have identifiers so that the containers and bases can be tracked individually and / or combined, even when separated.
[00227] In some cases, any number of containers can be provided inside the sample collection device. Sample containers may be able to receive sample received from an object. Each sample container can have a unique identifier. The unique identifier can be associated with any information regarding the sample, subject, device or device component.
[00228] In some cases, each identifier for each container can be unique. In other embodiments, the identifier on the container does not need to be unique, but it can be unique for the device, the object, or the type of sample.
[00229] A sample collection device can receive a sample from an individual. The subject can directly contact the sample collection device or provide the sample to the device. The sample can travel through the device to one or more containers inside the device. In some cases, the sample can be treated before reaching the containers. One or more coating substances can either be supplied within a sample collection unit and / or the channel that can transport the sample to the containers. Alternatively, treatment is not provided for the sample before it reaches the container. In some embodiments, the sample may or may not be treated within the container. In some cases, a plurality of different types of treatments may be provided to a sample before or when the sample reaches the container. Treatments can be provided in a pre-selected order. For example, a desired first treatment first, and may be provided upstream of a second treatment. In some cases, the sample is not treated at any point.
[00230] In some embodiments, the sample may be a blood sample. A first container can receive whole blood and a second container can receive blood plasma. Anticoagulants can be provided along the path of the fluid and / or in the containers.
[00231] Once the sample has been delivered to the containers and the containers have been sealed, the containers can be sent to a separate location for sample analysis. The separate location can be a laboratory. The location can be separated from a remote unit in relation to the sample collection location. The entire sample collection device can be shipped to a separate location. One or more identifiers can be provided on the sample collection device and can be useful for identifying the sample collection device and / or the containers inside it. Alternatively, the base (1340) can be removed from the sample collection device and can be sent to a separate location with the containers in them. One or more identifiers can be provided on the base and can be useful for identifying the base and / or the containers inside. In some cases, containers can be removed from the base and can be shipped to a separate location. One or more identifiers can be provided in each container, and can be useful for identifying the containers.
[00232] The identifiers can be read by any suitable technique. As an example and not a limitation, in some cases, the identifiers are read using an optical detector, such as an image capture device or a barcode scanner. In one example, an image capture device can capture an image from a QR code. Container information can be tracked. For example, when a container arrives at a location, the identifier can be scanned, and the container's arrival record can be kept. The progress and / or location of the container can be updated actively and / or passively. In some cases, the identifier may have to be scanned intentionally in order to determine the location of the container. In other examples, the identifier can actively emit a signal that can be picked up by signal readers. For example, as an identifier travels through a building, signal readers can control the location of the identifier.
[00233] In some cases, reading the identifier may allow a user to access additional information associated with the identifier. For example, the user can capture an image of the identifier using a device. The device or other device may display information about the sample, subject to reservation, device, device component, or any other information described here elsewhere. Information about tests to be performed and / or test results can be included. The user can perform subsequent tests or actions on the sample based on information associated with the identifier. For example, the user can direct the container to the appropriate place for a test. In some cases, the container may be directed to an appropriate location and / or the sample processing has been appropriate (for example, sample preparation, testing, detection, analysis) carried out on the contents of the container in an automated manner without the need for human intervention.
[00234] Data related to sample processing can be collected and associated with the identifier. For example, if a container has an identifier and sample processing has been performed on the contents of the container, one or more signals produced in response to the sample treatment can be stored and / or associated with the identifier. Such changes can be made in an automated way without the need for human intervention. Alternatively, a user can start storing information or can manually enter information. Thus, medical records related to a subject can be aggregated in an automated way. Identifiers can be useful for indexing and / or accessing information related to the subject. Fluid containers
[00235] Figures 18A-18B show a non-limiting example of a (1800) container that can be used with a sample collection device in accordance with an embodiment described herein. In some cases, the containers can be supported by the sample collection device. The containers can be comprised or surrounded by a portion of the sample collection device. In one example, the sample collection device may have a first configuration in which the containers are completely closed. A second configuration can be provided when the sample collection device can be opened and at least a part of the containers can be exposed. In some examples, the containers can be supported and / or at least partially closed by a base of the sample collection device. The base can be separable from the rest of the sample collection device, thereby providing access to the containers therein.
[00236] In one embodiment, a container (1800) comprises a body (1810) and a lid (1820). In some cases, the container body can be formed from a transparent or translucent material. The container body can allow a sample supplied inside the container body to be visible when viewed from outside the container. The container body can be optically transmissive. The container body can be formed of a material that can allow electromagnetic radiation to pass through. In some cases, the container body may be formed of a material that can allow the chosen wavelengths of electromagnetic radiation to pass while not allowing other unselected wavelengths of electromagnetic radiation to pass. In some cases, part or all of the body may be formed of a material that is opaque along chosen wavelengths of electromagnetic radiation, such as visible light wavelengths.
[00237] An open end and a closed end can be supplied to a container body (1810). The open end can be a top end (1812) of the container (1800), which can be at the end that can be configured to engage with a lid. The closed end can be a bottom end (1814) of the container, which can be at the end of the container opposite the lid. In alternative embodiments, a lower end can also be an open end that can be closed with a floor. In some embodiments, the cross-sectional area and / or the shape of the upper end and the lower end can be substantially the same. Alternatively, the cross-sectional area of the upper end may be larger than the cross-sectional area of the bottom end, or vice versa. There may be variations and alternatives to the embodiments described here and that the only embodiment should not be interpreted in such a way as to cover the entire invention.
[00238] A container body can have an inner surface and an outer surface. The surfaces of the container body can be smooth, rough, textured, faceted, shiny, dull, contain grooves, contain grooves, or have any other characteristic. The surface of the container body can be treated to provide a desired optical property. Internal surfaces and external surfaces can have the same properties or they can be different. For example, an outer surface can be smooth, while the inner surface is rough.
[00239] The container body may have a tubular shape. In some cases, the container body may have a cylindrical portion. In some cases, the container may have a circular cross-sectional shape. Alternatively, the container may have any other shape in cross section which may include elliptical, triangular, quadrangular (e.g., square, rectangular, trapezoidal, parallelogram), pentagonal, hexagonal, heptagonal, octagonal or otherwise. The shape of the container cross section may or may not be convex and / or concave. The shape of the container cross-section can remain the same along the length of the container, or it can vary. The container can have a prismatic shape along the length of the body. The prism may have a cross-sectional shape as described here.
[00240] The bottom of the container (1814) can be flat, tapered and rounded, or any combination thereof. In some cases, the container may have a hemispherical bottom. In other embodiments, the container may have a rounded bottom with a flat portion. The container may or may not be able to stand on a flat surface on its own.
[00241] The (1800) containers can be sized to contain a small sample of fluid. In some embodiments, the containers can be configured to contain no more than about 5 ml, 4 ml, 3 ml, 2 ml, 1.5 ml, 1 ml, 900 uL, 800 uL, 700 uL, 600 uL , 500 ul, 400 ul, 300 ul, 250 ul, 200 ul, 150 ul, 100 ul, 80 ul, 50 ul, 30 ul, 25 ul, 20 ul, 10 ul, 7 ul, 5 ul, 3 uL, 2 uL, 1 uL, 750 NL, 500 nL, 250 nL, 200 nL, 150 nL, 100 NL, 50 nL, 10 nL, 5 nL, 1 NL, 500 pL, 300 pL, 100 Pl, 50 Pl, 10 Pl, 5 Pl, or 1 PL. The containers can have the identifiers on it as discussed for Figures 16 and 17. In a non-limiting example, the containers (1800) can keep the small volume of the fluid sample in liquid form without using an absorbent material or the like to maintain o fluid sample during transport. This allows the sample fluid to be substantially removed in liquid form from the container without loss due to the liquid being absorbed by the wicking material.
[00242] Containers from (1800) can be configured to contain no more than a few drops of blood, a drop of blood, or no more than a portion of a drop of blood. For example, the container may have an interior volume that is not greater than the amount of fluid sample it is configured to contain. Having a small container volume, it can advantageously allow the storage and / or transport of a large number of containers within a small volume. This can reduce the resources used to store and / or transport the containers. For example, less storage space may be required. In addition, lower cost and / or fuel can be used to transport the containers. For the same amount of effort, a larger number of containers can be transported.
[00243] In some embodiments, the container (1800) can be short in length. For example, the length of the container can be 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm 3 cm, 2.5 cm, 2 cm, 1.7 cm, 1, or more 5 cm, 1.3 cm, 1.1 cm, 1 cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm, 0.4 cm, 0.3 cm , 0.2 cm, 0.1 cm, 700 um, 500 m, 300 um, um, 70 100, 50 um um, um 30, 10 um, 7 um, um 5, 30 um, or 1 um. In some cases, the largest dimension of the container (for example, length, width or diameter) may be greater than 8 cm, 7 cm, 6 cm, 5 cm, 4 cm, 3.5 cm 3 cm, 2.5 cm, 2 cm, 1.7 cm, 1.5 cm, 1.3 cm, 1.1 cm, 1 cm, 0.9 cm, 0.8 cm, 0.7 cm, 0.6 cm, 0.5 cm , 0.4 cm, 0.3 cm, 0.2 cm, 0.1 cm, 700 um, 500 m, 300 um, 100 um, 70 um, 50 um, 30 um, 10 um, 7 um, um 5 , 30 um, or 1 um.
[00244] The container (1800) can have any cross-sectional area. The cross-sectional area can be no more than about 8 cm 2, 7 cm 2, 6 cm 2, 5 cm 2 to 4 cm 2, 3.5 cm 2, 3 cm 2, 2.5 cm 2, 2 cm 2, 1.5 cm 2, with 1 cm 2, 0.9 cm 2, 0.8 cm 2, 0.7 cm 2, 0.6 cm 2, 0.5 cm 2, 0.4 cm 2, 0 .3 cm 2, 0.2 cm 2, 0.1 cm 2, 0.07 cm 2, 0.05 cm 2, 0.03 cm 2, 0.02 cm 2, 0.01 cm 2, 0.5 centimeters 2, 0.3 centimeters 2, or 0.1 centimeters 2. The cross-sectional area may remain the same or may vary over the length of the container.
[00245] The container (1800) can have any thickness. The thickness may remain the same over the length of the container or may vary. In some cases, the thickness can be selected and / or may vary in order to provide a desired optical property. In some cases, the thickness may be greater than 5 mm, 3 mm, 2 mm, 1 mm, 700 µm, 500 µm, 300 µm, 200 µm, 150 µm, 100 µm, 70 µm, 50 µm, 30 µm , 10 um, 7 um, um 5, 3 um, 1 um, 700 nm, 500 nm, 300 nm or 100 nm.
[00246] The container (1800) can have a favorable shape allowing centrifugation of small volume blood samples. This allows the sample collected in the containers to be taken directed to a centrifuge without having to transmit the sample fluid with yet another container that is used in the centrifuge.
[00247] The containers can contain a lid (1820). The lid can be configured to fit over an open end of the container. The lid can block the open end of the container. The lid can seal the container fluidly. The lid can form a fluid-tight seal with the container body. For example, the cap may be gas and / or impermeable liquid. Alternatively, the cap may allow some gases and / or liquids to pass through. In some cases, the cap may be permeable to gases while being impermeable to liquids. The lid may be impermeable to the sample. For example, the cap may be impermeable to whole blood, serum or plasma.
[00248] The lid can be configured to engage with the container body in any way. For example, the lid can be snap-fit with the container body. A friction fit can allow the cap to stay on the body. In other examples, a locking mechanism may be provided, such as a mechanism for sliding, clamping, closing, or any other technique. In some cases, the lid and / or the container body can be threaded to allow a screw-type coupling. In other examples, adhesives, soldering, brazing, or brazing can be used to attach the lid to the container body. The lid can be removably attached to the container body. Alternatively, the lid can be permanently attached to the body of the container.
[00249] In some cases, a portion of the lid may fit a portion of the container body. The lid can form a stopper with the container body. In some cases, a portion of the container body may fit a portion of the lid. The plug may include a lip or shelf that may fall on a portion of the container body. The lip or shelf can prevent the lid from sliding into the body of the container. In some cases, a part of a lid may overlap an upper and / or lateral part of the container body. Optionally, some embodiments may include an additional part in the vessel set, such as cap holder. In one embodiment, the purpose of the lid support is to maintain a tight seal between the lid and the container. In one embodiment, the lid support engages an attachment, a lip, indentation, or other attachment location on the outside of the container to hold the lid in place. Optionally, some embodiments can combine the function of both the cap and the cap support in one component.
[00250] In some embodiments, the container body can be formed of a rigid material. For example, the body of the container can be formed of a polymer, such as polypropylene, polystyrene, or acrylic. In alternative embodiments, the container body can be semi-rigid or flexible. The container body can be formed from a single integral part. Alternatively, several parts can be used. The various parts can be formed from the same or different materials.
[00251] The lid of the container can be formed of an elastomeric material, or any other material described here elsewhere. In some cases, the cap can be formed from rubber, polymer, or any other material that can be flexible and / or compressible. Alternatively, the lid can be semi-rigid or rigid. The lid of the container can be formed from a high friction material. The tank lid may be able to be able to rub against the container body. When the container lid is engaged with the container body, a fluid-tight seal can be formed. The interior of the container body can be fluidly isolated from ambient air. In some cases, at least one of the lid and / or portion of the container body in contact with the lid can be formed from high friction and / or compressible material.
[00252] The container lid can be formed from a single integral piece. Alternatively, several parts can be used. The various parts can be formed from the same or different materials. The material of the lid can be the same as or different from the material of the container body. In one example, the container body can be formed from an optically transmissive material, while the lid is formed from an opaque material.
[00253] The cover (1820) can be removably engaged with the body. A portion of the cap can be inserted into the body. The lid may include a lip that can rest on top of the body. The lip is not inserted into the body. In this non-limiting example, the lip can prevent the cap from being fully inserted into the body. The lip may form a continuous flange around the cap. In some cases, a portion of the lip may overlap or overlap a portion of the body. A portion of the body can be inserted into a portion of the lid.
[00254] The part of the cover that can be inserted into the body may have a rounded bottom. Alternatively, the portion may be flat, tapered, curved, contoured, or any other shape. The plug can be shaped to be easily inserted into the body.
[00255] In some cases, a depression can be provided at the top of the lid. The depression can follow the part of the cap that is inserted into the body. In some cases, a cavity or depression may be provided in the lid. The depression may be able to accept a portion of a channel that can be used to deliver a sample to the recipient. The depression can help guide the channel to a desired portion of the cap. In one example, the channel can be positioned within the depression before placing the channel and interior of the container in fluid communication.
[00256] The channel and lid can be pressed together so that the channel penetrates the lid and enters the interior of the container, which raises the channel and interior of the container in fluid communication. In some cases, the lid may have an opening through which the channel passes. Alternatively, the channel can prick through uninterrupted cap material. The channel can be removed from the container, which raises the channel and out of the fluid communication container. The cover may be able to reseal when the channel is removed. For example, the plug may be formed from a self-repairing material. In some cases, the cover may have an opening that can close when the channel is removed, thus forming a fluid-tight seal.
[00257] In some embodiments, the body may include one or more flange or other surface features. Examples of surface features may include flanges, bumps, protrusions, grooves, grooves, lines, holes, facets, or any other surface feature. The flange and / or other surface feature can circumscribe the body. The flange and / or surface feature may be located at or near the top of the body. The flange and / or other surface feature may be located in the upper half, upper part of the third, upper fourth, upper part of the fifth, upper sixth, upper part of the eighth, tenth or upper part of the body. The surface characteristics can be useful for supporting the container within a sample collection device. The surface characteristics can be useful for removing the container from the sample collection device and / or positioning the container inside the sample collection device. The flange and / or other surface feature may or may not wrap with the cover.
[00258] The lid can have any dimension in relation to the container body. In some cases, the cover and / or body may have areas of similar cross section. The lid may have the same, or substantially similar, cross-sectional area and / or shape as the upper body. In some cases, the cover may be shorter than the body. For example, the cap can be of a length that can be less than 60%, 50%, 40%, 30%, 25%, 20%, 15%, 10%, 7%, 5%, 3% or 1% body length.
[00259] Referring now to Figures 18C to 18E, yet another embodiment of the container (1800) may include a lid support 1830 that fits over the lid to hold the lid in place. As a non-limiting example, the lid of the port-1830 may also include an opening in the lid holder 1830 that allows a member such as an adapter to slide through and penetrate the lid (1820). Figure 18C shows the parts in an exploded view.
[00260] Figure 18D shows a cross-sectional view, showing an embodiment in which the body of the container with a lid (1810) (1820) covered by an 1830 buffer holder. As can be seen in Figure 18D, the lid holder 1830 has a locking feature 1832 for securing the lid holder 1830 to (1810) of the container body and / or the lid (1820). In one embodiment, the locking member 1832 comprises an inner ridge which will surround one or more of the ribs (1812) and (1814) on the body of the container (1810). Figure 18E shows a side view of the lid support 1830 coupled to the container body (1810).
[00261] With reference now to Figures 19A to 19C, various embodiments of a front end of a sample collection device will now be described. Figure 19A shows a view of a front end of the sample collection device with openings 1103 and 1105 for their respective channels. In the present embodiment, the openings (1103 and 1105) are placed in close proximity to each other with the dividing wall (1910) between the openings (1103 and 1105). In a non-limiting example, the partition wall thickness (1910) is configured to have the minimum thickness that can be formed reliably by means of a manufacturing process used to form the sample collection device. In one embodiment, the wall thickness should be about 1-10 mm. In some embodiments, instead of being side by side, the openings 1103 and 1105 can have a top-down configuration, a diagonal configuration, or another configuration in which the two openings are in close proximity to each other.
[00262] Referring now to Figure 19B, in this embodiment it shows the openings (1910) and (1912) configured to be coaxial, relative to each other. This coaxial configuration of openings (1910) and (1912) allows for greater overlap between the two openings.
[00263] With reference now to Figure 19C, this embodiment is similar to that of Figure 19B, except that, instead of square shaped openings, these openings (1920) and (1922) are round. It should be understood that any variety of shapes can be used, including, but not limited to, circular, elliptical, triangular, quadrangular (e.g. square, rectangular, trapezoidal), another shape of pentagonal, hexagonal, octagonal, or any. Naturally, it should be understood that different shapes can be used for each opening and that a collection device does not have to have the same shape as the cross section of all openings. Some embodiments may have a cross-sectional shape of the opening for one, but have a different cross-sectional shape for the channel downstream of the opening. Single sample collection device channel
[00264] Referring now to Figures 20A-20B, although the embodiments here are typically described as sample collection devices with two separate channels, it should be understood that some embodiments may use a single input channel 2010. This single entry channel may or 2010 not be lined. Suitable coatings include, but are not limited to, an anticoagulant, plasma, or other materials.
[00265] Figure 20A shows that in this embodiment of the 2000 sample collection device, a penetrating tissue member 2112 can be mounted coaxially within the single entry pathway of 2010. This allows the wound in the target tissue to be formed in a way that will be aligned with the only entry route 2010. Penetration into the limb tissue 2012 can be activated by one of a variety of techniques, such as, but not limited to, the act of pressing a trigger, the actuation on contact of the front end of the device with the target tissue, or by pressure as the device is pressed against the target tissue with sufficient pressure. After the actuation, penetration in the limb tissue 2012 can remain in the single entry route 2010. Optionally, penetration in the limb tissue 2012 can retract out of the single entry route 2010.
[00266] The sample fluid entering the 2000 sample collection device can split into two or more separate paths 2014 and 2016 from the single entry path in 2010. This allows the sample fluid to be divided into at least least two portions of a sample taken from a single point of contact. The two portions can optionally be carried out in two separate holding chambers 2018 and 2020. These chambers can each have one or more adapter channels 2022 and 2024 to transfer the fluid sample to the containers, such as, but not limited to to 1146a and 1146B containers. It should be understood that the 2018 and 2020 holding chambers and / or containers 1146a and 1146B may contain anticoagulant there to prepare the fluid sample for processing.
[00267] With reference now to Figure 20B, in this embodiment it shows that the only entry route 2010, with a penetration in the member fabric 2012 there, which, after the performance, is configured to remain in whole or in part, within the single 2010 entry route. It should be understood that this embodiment may use a penetrating element or a solid that is hollow, with a lumen in it.
[00268] With reference now to Figure 21, yet another embodiment of a 2030 sample collection device will now be described. This embodiment has a reduced length only 2032 entry pathway, with a penetration into the limb tissue 2012 configured to extend outward from the 2032 pathway. After actuation, penetration into the limb tissue 2012 may be on the path 2032 or , optionally, not to be retracted on the 2032 route. The sample fluid entering the 2030 sample collection device can split into two or more separate paths 2034 and 2036 from the single 2032 inlet path. This allows the sample fluid to be divided into at least two portions of a sample taken from a single point of contact. This embodiment shows that the routes 2034 and 2036 remain in the configuration of the capillary channel and do not enlarge to become chambers like the embodiments of Figures 20A-20B. It should be understood that any of the embodiments described herein may include one or more filling indicators for the collection routes and / or the containers on the devices, so that users can know when sufficient filling levels have been reached .
[00269] It should also be understood that, due to the small volume of the sample collected with containers, such as, but not limited to 1146a and 1146B containers, the "pull" from the reduced pressure, such as, but not limited to, the pressure vacuum, in the containers is minimally or not transferred to the individual's body in a way that can collapse or detrimentally reshape the blood vessel or other lumen of sample fluid being collected. For example, pediatric and geriatric patients generally have small and / or weak veins that can collapse when traditional, large volume vacutainers are used, due to the higher vacuum forces associated with the larger sample design for these traditional containers. In at least one embodiment of the device, you will not have this problem as it will not transmit a vacuum (aspiration) force over the vein. In one embodiment, the amount of vacuum force draws no more than 120 µL of sample fluid in container 1146a. Optionally, the amount of vacuum force draws no more than 100 µL in the 1146a container. Optionally, the amount of vacuum force draws no more than 80 µL into the 1146a container. Optionally, the amount of vacuum force does not exceed 60 | iL for the 1146a container. Optionally, the amount of vacuum force flame does not exceed 40 | iL for the 1146a container. Optionally, the amount of vacuum force does not exceed 20 | iL for the 1146a container. In one embodiment, this type of drawing is carried out without the use of a syringe and is mainly based on the pull force from the containers and any force of the fluid that leaves the subject. Optionally, the form route through the device for drawing sample that has reached an interior of the device can help to reduce the transfer of force from containers 1146a and 1146B to the subject's blood vessel or other lumens of the human body. Some embodiments may use about three or less quarters of a vacuum in the small volume containers listed above, to minimize sample hemolysis and to prevent blood vessel collapse in the subject. Some embodiments may use about half or less of vacuum in the small volume containers listed above, to minimize sample hemolysis and to prevent blood vessel collapse in the subject. Some embodiments can use about a quarter or less of vacuum in the small volume containers listed above to minimize sample hemolysis and to prevent blood vessel collapse in the subject. Vacuum is total vacuum here, in relation to atmospheric pressure.
[00270] It should also be understood that, in one embodiment, the cross-sectional area chamber in the device is larger than the diameter of the needle cross section and / or flexible tubing used to pull the subject's body fluid. This also helps in reducing the transfer of force to the subject. The vacuum forces of the containers are transferred more quickly in the sample liquid, in the device, not directly in the sample, where the needle is closest to the object. The longest path, buffered by the largest volume chamber in the collection device, cushions the pulling of the blood vessel in the subject. In addition, the initial peak pull force is substantially less in a small volume vessel compared to a larger volume vessel that is also under vacuum. The duration of the "pull" is also longer to allow the largest amount of sample to enter the container. In a smaller volume, a significant portion of the sample is collected is already in the device, and there is less that is drawn from the subject who is no longer in the device, before starting to draw the sample. Modular Sample Collection Device
[00271] Referring now to Figures 22A-22C, although the embodiments here typically describe the sample collection device, as having an adapter channel for connecting the sample collection channels with the containers, it should be understood that forms of without these settings being deleted.
[00272] As a non-limiting example in figure 22A, as previously suggested here, some embodiments can be without a discrete, separate adapter channel. Here, the collection channel 2422 can connect directly to the 2446 container by means of the relative movement between one or both of these elements, as indicated by the arrow 2449.
[00273] As a non-limiting example in Figure 22B, one or more adapter channels 2454 may be discrete elements not initially in direct fluid communication with the collection channel or 2422 or the 2446 containers. Here, the collection channel 2422 can connect to the 2446 container by means of the relative movement between one or more of the collection channel, the adapter channel (s) 2454, 2446 or the container (sequentially or simultaneously) to create a fluid passage from the collection channels through one or more adapter channels the containers.
[00274] As a non-limiting example, in Figure 22C, one or more adapter channels 2454 may be elements initially in contact with the containers of 2446. The adapter channels 2454 may not be directly in communication with the interior or the containers . Here, the collection channel 2400 can connect to the container by means of a relative movement between one or more elements (sequentially or simultaneously) to create a passage of fluid from the collection channels through one or more adapter channels in the containers. Some configurations may have a septum, sleeve, vented sleeve, or cover 2455 over the end of the collection channel that will be contracted by the adapter channel. The coupling of the various elements can also move the adapter channel 2454 into the container 2446, as initially, the adapter channel 2454 may not be in fluid communication with the interior. Some embodiments described herein may have more than the channel and adapter. Some embodiments may use adapter channels with the pointed ends at both ends of the channel. There may be variations and alternatives to the embodiments described herein and that the only embodiment should not be interpreted in such a way as to cover the entire invention.
[00275] It should be understood that any of the embodiments herein can be modified to include the characteristic features referred to in the description of Figures 22A-22C. Service Point System
[0001] Referring now to Figure 23, it should be understood that the processes described here can be performed using automated techniques. Automated processing can be used in an integrated, automated system. In some embodiments, this can be on the same instrument that has a plurality of functional components thereof and surrounded by a common housing. Transformation techniques and sedimentation measurement methods can be predefined. Optionally, which can be based on protocols or procedures which can be changed dynamically as desired in the manner described in US patent applications 13 / 355,458 and 13 / 244,947, both of which are incorporated herein by reference for all purposes.
[0002] In a non-limiting example, as shown in Figure 23, an integrated 2500 instrument can be provided with a 2502 programmable processor, which can be used to control a plurality of instrument components. For example, in one embodiment, processor 2502 can control a single or multiple pipette system 2504 which is movable XY and Z as indicated by arrows 2506 and 2508. The same or different processors can also control other components 2512, 2514 , or 2516 on the instrument. In one embodiment, the tone components of 2512, 2514, or 2516, comprise a centrifuge.
[0003] As can be seen in Figure 23, control by the 2502 processor can allow the pipette system 2504 to acquire blood sample from the 2510 cartridge and move the sample to one of the 2512, 2514, or 2516 components. Such movement may involve distributing the sample to a removable container in the 2510 cartridge and then the removable transport container for one of the 2512, 2514, or 2516 components. Optionally, the blood sample is applied directly to an already assembled container on one of the components 2512, 2514, or 2516. In a non-limiting example, one of these components 2512, 2514, or 2516 can be a centrifuge with a configuration to allow imaging for illumination and visualization of the sample in the container. Other components 2512, 2514, 2516 or perform other analysis, testing, or detection functions.
[0004] All of the above provisions can be integrated into a single 2520 housing and configured for bench or small track mounting footprint. In one example, a small footprint floor mounting system can occupy an area of about 4 m 2 or less. In one example, a small footprint floor mounting system can occupy an area of about 3 m 2 or less. In one example, a small footprint floor mounting system can occupy an area of about 2 m 2 or less. In one example, a small footprint floor mounting system can occupy an area of about 1m 2 or less. In some embodiments, the footprint of the instrument may be less than or equal to about 4 m 2, 3 m 2,2,5 m 2,2 m 2, 1,5 m 2, 1 m 2, from 0, 75 m 2, 0.5 m 2, 0.3 m 2.0.2 m 2.0.1 m 2, 0.08 m 2, 0.05 m 2, 0.03 m 2, 100 2 cm, 80 cm 2 and 70 cm 2, 60 cm 2, 50 cm 2, 40 cm 2, 30 cm 2, 20 cm 2, 15 cm 2, 10 cm or 2. Some suitable systems in a point-of-service service environment described in US Ser patent applications. Nos. 13 / 355,458 and 13 / 244,947, both of which are incorporated herein by reference for all purposes. The present embodiments can be configured for use with any of the modules or systems described in these patent applications.
[00276] While the teachings have been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions or additions of processes and protocols can be made without departing from the spirit and scope of the invention. For example, with any of the above embodiments, it should be understood that the fluid sample can be whole blood, diluted blood, interstitial fluid, sample obtained directly from the patient, the sample that is on a surface, sample after some pretreatment, or the like. Those skilled in the art will understand that alternative embodiments may have more than one container that can be sequentially operatively coupled to the needle or opening the channel to extract the liquid in the container. Optionally, some embodiments may have the containers configured to operatively couple to the channels simultaneously. Some configurations may integrate a puncture device or other wound creation device with the sample collection device to bring sample fluid directed to a tissue surface and then collect the sample fluid, all using a single device. As a non-limiting example, a spring actuated, mechanically actuated, and / or electromechanically actuated tissue penetrating element can be mounted to have a penetrating tip exit near an end of the sample collection device near sample collection channel openings so that the wound site that is created will also be along the same end of the device as the collection openings. Optionally, an integrated device can have collection openings on one surface and tissue penetrating elements along another surface of the device. In any of the embodiments described here, the first opening of the collection channel can have a blunt shape, which is configured to not easily pierce human skin.
[00277] In addition, the use of heat patches on the finger or other target tissue can increase blood flow to the target area and thus increase the speed with which sufficient blood or other body fluid can be drawn from the subject . Heating is used to bring the target tissue to about 40C to 50C. Optionally, heat brings target tissue to a temperature range of about 44 to 47 ° C.
[00278] Furthermore, those skilled in the art will recognize that any of the embodiments, as described herein, can be applied to the collection of sample fluid from humans, animals, or other subjects. Some embodiments as described herein may also be suitable for taking samples of non-biological fluids. Some embodiment may use containers that are not removable from the carrier. Some may have the fluid sample, after it has been measured in the sample collection portion, be directed by the second driving force to a cartridge which is then placed in an analyte or other analysis device. Optionally, it should be understood although many embodiments show the containers on conveyors, embodiments in which the containers are bare or not mounted on a vehicle are not excluded. Some configurations may have containers that are separated from the device and are only brought in for fluid communication once the channels have reached minimum fill levels. For example, containers can be kept in a different location and are only put in contact by a technician, once sufficient amount of blood or sample fluid is in the sample collection device. At that time, the containers can be placed in fluid communication, simultaneously or sequentially to one or more of the channels of the sample collection device.
[00279] In addition, concentrations, quantities, and other numerical data can be presented here in a strip format. It is to be understood that such a gamma format is used merely for convenience and brevity and should be interpreted flexibly to include not only numerical values expressly recited as the limits of the range, but also all individual numerical values or sub-ranges encompassed within of that range, as if each numerical and sub-range value is expressly recited. For example, a size range of about 1 nm to about 200 nm, should be interpreted to include not only the explicitly quoted limits of about 1 nm and about 200 nm, but also to include individual sizes, such as 2 nM, 3 nM, 4 nm and sub-ranges, such as 10 nm to 50 nm, 20 nm and 100 nm, etc.
[00280] The publications discussed or cited in this document are provided for publication only before the date of submission of this application. Nothing herein should be construed as an admission that the present invention has no right to predate such publication by virtue of a previous invention. In addition, the publication dates provided may differ from the actual publication dates which may need to be confirmed independently. All publications mentioned herein are hereby incorporated by reference to reveal and describe the structures and / or methods in connection with which the publications are cited. The following orders are incorporated herein by reference for all purposes: in US Provisional Patent Application No. 61 / 435,250, filed January 21, 2011 ("SYSTEMS AND METHODS FOR THE USE OF SAMPLE MAXIMIZATION"), and US 2009/0088336 ("MODULAR POINT OF CARE DEVICES, SYSTEMS AND USE OF THE SAME").
[00281] In one embodiment described herein, a device for collecting a sample of body fluid from a subject is provided comprising: at least two sampling routes configured to extract the sample of body fluid into the device from a single end of the device in contact with the subject, thereby separating the fluid sample into two separate samples; a second part comprising a plurality of sample containers for receiving the sample of body fluid collected in the sample collection pathways, the sample containers to be operably dockable fluid communication with the sample collection pathways, after which, when the Fluid communication is established, the containers provide a driving force to move most of the two separate samples from the pathways within the containers.
[00282] In another embodiment described herein, a device for collecting a sample of body fluid is provided comprising: a first location portion comprising at least one fluid collection that leads to at least two collection paths samples configured to extract the fluid sample in it through a first type of driving force; a second part comprising a plurality of sample containers for receiving the sample of body fluid collected in the sample collection pathways, sample containers operably pluggable to be in fluid communication with the sample collection pathways, after which, when fluid communication is established, the containers provide a second driving force different from the first driving force to move most of the body fluid sample from the paths into the containers; wherein at least one of the sampling pathways comprises a fill indicator to indicate when a minimum level of filling has been reached and that at least one of the containers can be coupled to be in uid F communication with at least one of the pathways sample collection.
[00283] In another embodiment described herein, a device for collecting a sample of body fluid is provided comprising a first part comprising at least two sample collection channels configured to extract the sample of fluid into the channels sampling using a first type of driving force, where one of the sampling channels has an inner liner designed to mix with the fluid sample and another of the sampling channels has another chemically different inner liner said interior lining; a second part comprising a plurality of sample containers for receiving the sample of body fluid collected in the sampling channels, the sample containers operably pluggable to be in fluid communication with the collection channels, after which, when the communication of fluid is established, the containers provide a second reason to force other than the first driving force to move most of the body fluid sample from the channels within the containers; wherein the containers are arranged in such a way that mixing of the fluid sample between the containers does not occur.
[00284] In another embodiment described herein, a device for collecting a sample of body fluid is provided comprising: a first part comprising a plurality of sample collection channels, wherein at least two of the channels are configured to pull simultaneously, the fluid sample in each of the os, at least two channels of sample collection through a first type of driving force; a second part comprising a plurality of sample containers for receiving the body fluid sample collected in the sample collection channels, wherein the sample containers have a first state in which the sample containers are not in fluid communication with the sample channels. sample collection, and a second condition where the sample containers are operably dockable to be in fluid communication with the collection channels, after which, when fluid communication is established, the containers provide a second driving force different from first driving force to move body fluid sample from channels to containers.
[00285] In another embodiment described herein, a sample collection device is provided comprising: (a) a collection channel comprising a first opening and a second opening, and being configured to extract a sample of body fluid through a capillary action from the first opening to the second opening; and (b) a sample container for receiving the body fluid sample, the container being able to engage with the collection channel, having an interior with a vacuum inside it, and having a lid configured to receive a channel; wherein the second opening is defined by a portion of the collection channel configured to penetrate the sample container lid, and to provide a fluid flow path between the collection channel and the sample container, and the sample container has an interior volume not greater than ten times greater than the interior volume of the collection channel.
[00286] In another embodiment described herein, a sample collection device is provided comprising: (a) a collection channel comprising a first opening and a second opening, and being configured to extract a sample of body fluid through a capillary action from the first opening to the second opening; (B) a sample container for receiving the body fluid sample, the container being able to engage with the collection channel, having an interior with a vacuum inside it, and having a lid configured to receive a channel; and (c) a channel adapter configured to provide a fluid flow path between the collection channel and the sample container, which has a first opening and a second opening, the first opening being configured to contact the second channel opening the second opening being configured to penetrate the sample container lid.
[00287] In another embodiment described herein, a sample collection device is provided comprising: (a) a body, containing a collection channel, the collection channel comprising a first and a second opening, and being configured to extract a body fluid through the capillary action from the first opening to the second opening; (B) a base, which contains a sampling vessel to receive the body fluid sample, the sample vessel to be engaged with the collection channel, having an interior with a vacuum inside it, and having a lid configured to receive a channel; and (c) a support, in which the body and base are connected to the opposite ends of the support, and is configured to be movable in relation to the other, such that the sample collection device is configured to have an extended state and a compressed state, in which at least a portion of the base is closer to the body in the extended state of the device than in the compressed state, the second opening of the collection channel is configured to penetrate the lid of the sample container, in the state of the device extended, the second opening of the collection channel is not in contact with the interior of the sample container, and, in the compressed state of the device, the second opening of the collection channel extends into the sample container through the lid of the container, thus providing fluid communication between the collection channel and the sample container.
[00288] In another embodiment described here, a sample collection device is provided comprising: (a) a body, containing a collection channel, the collection channel comprising a first and a second opening, and being configured to extract a body fluid through the capillary action from the first opening to the second opening; (B) a base, containing a sampling vessel to receive the body fluid sample, the sample vessel to be engaged with the collection channel, having an interior with a vacuum inside it and having a lid configured to receive a channel; (C) a holder, and (d) an adapter channel, which has a first opening and a second opening, the first opening being configured to contact the second opening of the collection channel, and the second opening being configured to penetrate the cover of the sample container, in which the body and base are connected to the opposite ends of the holder, and are configured to be movable relative to each other, such that the sample collection device is configured to have an extended state and a compressed state, in which at least a portion of the base is closer to the body in the extended state of the device than in the compressed state, in the extended state of the device, the adapter channel is not in contact with one or both of the collection channel and the interior of the sample container, and, in the compressed state of the device, the first opening of the adapter channel is in contact with the second opening of the collection channel, and the second opening of the adapter channel extends and into the sample container through the container lid, thus providing fluid communication between the collection channel and the sample container.
[00289] In another embodiment described herein, a device for collecting a sample of fluid from a subject is provided comprising: (a) a body containing a collection channel, the collection channel comprising a first opening and a second opening, and being configured to draw a body fluid through the capillary action from the first opening to the second opening; (B) a base, engaged with the body, in which the base supports a sample container, the container being able to engage with the collection channel, having an interior with a vacuum inside it, and having a lid configured to receive a channel; wherein the second opening of the collection channel is configured to penetrate the sample container lid, and to provide a fluid flow path between the collection channel and the sample container.
[00290] In another embodiment described herein, a device for collecting a sample of fluid from a subject is provided comprising: (a) a body containing a collection channel, the collection channel comprising a first opening and a second opening, and being configured to draw a body fluid through the capillary action from the first opening to the second opening; (B) a base, can engage with the body, where the base supports a sample container, the sample container to be engaged with the collection channel, having an interior with a vacuum inside it and having a lid configured for receive a channel; and (c) an adapter channel, which has a first opening and a second opening, the first opening being configured to contact the second opening of the collection channel, and the second opening being configured to penetrate the sample container lid.
[00291] It should be understood that one or more of the following features can be adapted for use with any of the embodiments described here. As a non-limiting example, the body can comprise two collection channels. Optionally, the interior of the collection channel (s) are coated with an anticoagulant. Optionally, the body comprises a first collection channel and a second collection channel, and the interior of the first collection channel is coated with a different anticoagulant than the interior of the second collection channel. Optionally, the first anticoagulant is ethylene diaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA. Optionally, the first is anticoagulant citrate and the second anticoagulant is different from citrate. Optionally, the first anticoagulant is heparin and the second anticoagulant is different from heparin. Optionally, an anticoagulant is heparin and the second anticoagulant is EDTA. Optionally, an anticoagulant is heparin and the second anticoagulant is citrate. Optionally, an anticoagulant is citrate and the second anticoagulant is EDTA. Optionally, the body is formed from an optically transmitting material. Optionally, the device includes the same number of sample containers as the collection channels. Optionally, the device includes the same number of adapter channels as collection channels. Optionally, the base contains an optical indicator that provides a visual indication of whether the sample has reached the sample container on the base. Optionally, the base is a window that allows the user to see the container on the base. Optionally, the support comprises a spring, and the spring exerts a force so that the device is in the extended state when the device is in its natural state. Optionally, the second opening of the collection channel or the adapter channel is covered by a sleeve, wherein said sleeve does not prevent the movement of the body fluid through a capillary action from the first opening to the second opening. Optionally, the sleeve contains a vent. Optionally, each collection channel can contain a volume that is not greater than 500 ul. Optionally, each collection channel can contain a volume that is not greater than 200 ul. Optionally, each collection channel can contain a volume that is not greater than 100 ul. Optionally, each collection channel can contain a volume that is not greater than 70 A L. Optionally, each collection channel can contain a volume that is not greater than 500 ul. Optionally, each collection channel can contain a volume that is not greater than 30 A L. Optionally, the internal circumferential perimeter of a cross section of each collection channel is not greater than 16 mm. Optionally, the internal circumferential perimeter of a cross section of each collection channel is not greater than 8 mm. Optionally, the internal circumferential perimeter of a cross section of each collection channel is not greater than 4 mm. Optionally, the circumferential inner perimeter is a circumference. Optionally, the device comprises a first and a second collection channel, and the opening of the first channel is adjacent to an opening of said second channel, and the openings are configured to draw blood simultaneously from a single drop of blood. Optionally, the opening of the first channel and the opening of the second channel have a center to center spacing of less than or equal to about 5 mm. Optionally, each sample container has an interior volume no greater than twenty times greater than the interior volume of the collection channel with which it is pluggable. Optionally, each sample container has an interior volume of no more than ten times greater than the interior volume of the collection channel with which it can be fitted. Optionally, each sample container has an interior volume not greater than five times greater than the interior volume of the collection channel with which it is pluggable. Optionally, each sample container has an interior volume no greater than twice that of the interior volume of the collection channel with which it is pluggable. Optionally, the establishment of fluid communication between the collection channel and the sample container results in the transfer of at least 90% of the body fluid sample into the collection channel within the sample container.
[00292] It should be understood that one or more of the following characteristics can be adapted for use with any of the embodiments described here. Optionally, the establishment of fluid communication between the collection channel and the sample container results in the transfer of at least 95% of the body fluid sample in the collection channel within the sample container. Optionally, the establishment of fluid communication between the collection channel and the sample container results in the transfer of at least 98% of the body fluid sample in the collection channel within the sample container. Optionally, the establishment of fluid communication between the collection channel and the sample container results in the transfer of the body fluid sample into the sample container and in no more than ten μL of body fluid sample remaining in the collection channel. . Optionally, the establishment of fluid communication between the collection channel and the sample container results in the transfer of the body fluid sample into the sample container and in no more than five μL of body fluid sample remaining in the collection channel. . Optionally, the engagement of the collection channel with the sample container results in the transfer of the body fluid sample into the sample container and in no more than 2 μL of remaining body fluid sample in the collection channel.
[00293] In another embodiment described herein, a method is provided comprising contacting one end of a sample collection device to a body fluid sample to divide the sample into at least two portions of the sample in at least at least, two channels of sampling the device collection by means of a first type of driving force; establish fluid communication between the sample collection channels and the sample containers, after a desired amount of fluid sample has been confirmed to be at least one of the collection channels, after which the containers provide a second driving force different from the first driving force to move each of the body fluid sample portions into the respective containers.
[00294] In another embodiment described here, a method is provided which comprises measuring a minimum amount of sample in at least two channels using a sample collection device with at least two of the sample collection channels configured to pull simultaneously , the fluid sample in each of the at least two sample collection channels through a first type of driving force; after a desired amount of fluid sample has been confirmed to be in the collection channels, fluid communication is established between the sample collection channels and the sample containers, after which the containers provide a different second driving force from the first use driving force to collect the samples to move body fluid sample from the channels to the containers.
[00295] In another embodiment described herein, a method of collecting a sample of body fluid is provided comprising: (a) contacting a sample of body fluid with a device comprising a collection channel, the collection channel comprising a first opening and a second opening, and being configured to extract a body fluid through the capillary action from the first opening to the second opening, such that the body fluid sample fills the collection channel from the first opening through the second opening ; (B) establishing a fluid flow path between the collection channel and the interior of a sample container, said sample container having an interior volume not greater than ten times greater than the interior volume of the sample channel. collection and with a vacuum before the establishment of the fluid flow path between the collection channel and the interior of the sample container, such that the establishment of the fluid flow path between the collection channel and the interior of the sample container sampling generates negative pressure at the second opening of the collection channel, and the fluid sample is transferred from the collection channel into the sample container.
[00296] In another embodiment described herein, a method of collecting a sample of body fluid is provided comprising: (a) contacting a sample of body fluid with any collection device, as described herein, such that the body fluid sample fills the collection channel from the first opening through the second opening of at least one of the collection channels (s) in the device; and (b) establishing a fluid flow path between the collection channel and the interior of the sample container, such that establishing a fluid flow path between the collection channel and the interior of the sample container generates a negative pressure in the second opening of the collection channel, and the fluid sample is transferred from the collection channel into the sample container.
[00297] It should be understood that one or more of the following features can be adapted for use with any of the embodiments described here. Optionally, the collection channel and the interior of the sample container are not put into fluid communication until the body fluid reaches the second opening of the collection channel. Optionally, the device comprises two collection channels, and the collection channels and the interior of the sample containers are not put into fluid communication until the body fluid reaches the second opening of both collection channels. Optionally, the second opening of the collection channel, in which the device is configured to penetrate the sample container lid, and in which a fluid flow path between the second opening of the collection channel and the sample container is established at the providing relative movement between the second opening of the collection channel and the sample container, such that the second opening of the collection channel penetrates the lid of the sample container. Optionally, the device comprises an adapter for each collection channel channel on the device, the adapter channel that has a first opening and a second opening, the first opening being configured to contact the second opening of the collection channel, and the second opening being configured to penetrate the sample container lid, and in which a fluid flow path between the collection channel and the sample container is established by providing relative movement between two or more of the following: (a) the second opening of the collection channel, (b) the adapter channel, and (c) the sample container, such that the second opening of the adapter channel penetrates the lid of the sample container.
[00298] In another embodiment described herein, a method for collecting a sample of body fluid from a subject is provided comprising: (a) placing a device comprising a first channel and a second channel in fluid communication with a fluid body of the subject, each channel having an inlet opening configured for fluid communication with said body fluid, each channel having an outlet opening downstream of the inlet opening of each channel, and each channel being configured to extract a body fluid through a capillary action from the entrance opening towards the exit opening; (B) placing, through the opening of each of the first channel and the second outlet channel, said first channel and said second channel in fluid communication with a first container and a second container, respectively; and (c) directing said body fluid within each of said first and second channels to each channel of said first reservoir and second container, with the aid of: (i) negative pressure in relation to the ambient pressure in said first container or said second container, wherein said negative pressure is sufficient for the effect flow of said body fluid through said first channel or said second channel to its corresponding container, or (ii) the positive pressure in relation to the pressure environment upstream of said first channel or said second channel, wherein said positive pressure is sufficient to effect the flow of said whole blood sample through said first channel or said second channel to its corresponding container.
[00299] In another embodiment described herein, a method of manufacturing a sample collection device is provided comprising forming a portion of a sample collection device that has at least two channels configured to simultaneously pull the fluid sample in each of the at least two sampling channels through a first type of driving force; formation of sample containers, after which the containers are set up to be coupled to the sample collection device to provide a second driving force different from the first use driving force to collect the samples to move body fluid sample from the channels to the containers.
[00300] In another embodiment described herein, executable computer instructions are provided to perform a method comprising: forming a portion of a sample collection device that has at least two channels configured to simultaneously pull the fluid sample in each of the at least two sampling channels using a first type of driving force.
[00301] In another embodiment described herein, computer executable instructions that perform a method comprising: forming sample containers, after which the containers are configured to be coupled to the sample collection device to provide a second driving force other than the first use driving force to collect the samples to move body fluid sample from the channels to the containers.
[00302] In yet another embodiment described herein, a device for collecting a sample of body fluid from a subject, the device comprising: means for drawing the sample of body fluid into the device from a single end of the device in contact with the object, thus separating the fluid sample into two separate samples; means for transferring the fluid sample into a plurality of sample containers, wherein the containers provide a driving force to move most of the two separate samples from the pathways within the containers.
[00303] In another embodiment described herein, a method is provided comprising contacting one end of a body fluid sample collection device; and establish fluid communication between one or more sample collection channels in fluid communication with one or more sample containers, after which the containers provide a second driving force different from the first driving force to move the body fluid sample to the respective containers.
[00304] In another embodiment described herein, a device is provided for collecting a sample of body fluid from a subject, the device comprising: a collection portion for drawing the sample of body fluid into the device from a single end of the device in contact with the subject.
[00305] In another embodiment described herein, a device is provided for collecting a sample of body fluid from a subject, the device comprising: a collection portion for drawing the sample of body fluid into the device from a single end of the device in contact with the subject; a sample storage portion for receiving the fluid sample from the collection portion.
[00306] While the above description is a complete description of the preferred embodiment, as described here, it is possible to use several alternatives, modifications and equivalents. Therefore, the scope of the present invention should be determined not with reference to the previous description, but should instead be determined with reference to the appended claims, together with its full scope of equivalents. Any feature, whether preferred or not, can be combined with any other feature, whether preferred or not. The appended claims should not be construed to encompass limitations more than function, unless such limitation is explicitly recited in a particular claim using the phrase "means to." It is to be understood that, as used in the description and in all claims that follow, the meaning of "one", "one", and "o" includes plural reference unless the context clearly dictates otherwise. In addition, as used in the present description and in all claims that follow, the meaning of "in" includes "no" and "linked", unless the context clearly dictates otherwise. Finally, as used in the present description and in all claims that follow, the meanings of "e" and "or" include both the conjunctive and the disjunctive and can be used interchangeably unless the context expressly indicates otherwise. Thus, in contexts where the terms "and" or "or" are used, the use of such junctions does not exclude a "and / or" meaning unless the context expressly indicates otherwise.

权利要求:
Claims (13)
[0001]
1- DEVICE FOR THE COLLECTION OF BODY FLUID SAMPLES characterized by the fact that it comprises: a first portion comprising at least two sample collection channels (322a, 322b) configured to attract the fluid sample to the sample collection channels (322a, 322b) through a first type of driving force, where one of the sampling channels (322a, 322b) has an internal liner designed to mix with the fluid sample and another of the sampling channels (322a, 322b) has another inner coating chemically different from said inner coating; a second portion comprising a plurality of sample containers (346a, 346b) for receiving the body fluid sample collected in the sample collection channels (322a, 322b), the sample containers (346a, 346b) operably interlockable to be in communication fluid with the collection channels (322a, 322b), when fluid communication is established, in which the containers (346a, 346b) provide a second driving force different from the first driving force to move most of the body fluid sample from the channels (322a, 322b) for the containers (346a, 346b); wherein the containers (346a, 346b) are arranged in such a way that mixing of the fluid sample between the containers does not occur. 2- DEVICE FOR COLLECTING SAMPLES OF BODY FLUIDS according to claim 1, characterized by the fact that the inner lining comprises a first anticoagulant and the other inner lining comprises a second anticoagulant. 3- DEVICE FOR COLLECTING A FLUID SAMPLE FROM A SUBJECT, characterized by the fact that it comprises: (a) a body (1120) containing a collection channel (1126, 1128), the collection channel (1126, 1128), comprising a first opening and a second opening, and being configured to draw a body fluid by capillary action from the first opening to the second opening; (b) a base (1140), engageable with the body (1120), where the base (1140) supports a sample container (1146a, 1146b), the sample container (1146a, 1146b) being engageable with the collecting (1126, 1128), having an interior with a vacuum in it and having a lid (1148a) configured to receive a channel; and (c) an adapter channel (1150, 1152), having a first opening and a second opening, the first opening being configured to contact the second opening of the collection channel (1126, 1128) and the second opening being configured to penetrate the lid (1148a) of the sample container (1146a, 1146b); wherein the body (1120) comprises a first collection channel (1126) and a second collection channel (1128), and the interior of the first collection channel (1126) is coated with an anticoagulant different from the interior of the second collection channel (1128).
[0002]
4. DEVICE, according to claim 2 or 3, characterized by the fact that the first anticoagulant is ethylene diaminetetraacetic acid (EDTA) and the second anticoagulant is different from EDTA.
[0003]
5. DEVICE, according to claim 2 or 3, characterized by the fact that the first anticoagulant is citrate and the second anticoagulant is different from citrate.
[0004]
6. DEVICE, according to claim 2 or 3, characterized by the fact that the first anticoagulant is heparin and the second anticoagulant is different from heparin.
[0005]
7. DEVICE, according to claim 3, characterized by the fact that the body (1120) is formed from an optically transmissive material.
[0006]
8. DEVICE, according to claim 3, characterized by the fact that the base (1140) contains an optical indicator that provides a visual indication that the sample has reached the sample container in the base.
[0007]
9. DEVICE, according to claim 3, characterized by the fact that the base (1140) is a window that allows the user to see the container on the base.
[0008]
10. DEVICE, according to claim 1, characterized by the fact that the first portion is formed from an optically transmissive material.
[0009]
11. DEVICE, according to claim 1, characterized by the fact that the first portion comprises an optical indicator that provides a visual indication of whether the sample has reached the sample containers.
[0010]
12. DEVICE, according to claim 1, characterized by the fact that the first type of driving force comprises capillary force.
[0011]
13. DEVICE, according to claim 1, characterized by the fact that the second driving force comprises vacuum force.
[0012]
14. DEVICE, according to claim 1 or 3, characterized by the fact that the sample is capillary blood.
[0013]
15. DEVICE, according to claim 3, characterized by the fact that said at least one adapter channel (1150, 1152) has a width of the adapter channel less than the width of the sample collection channel.

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法律状态:
2018-05-29| B25A| Requested transfer of rights approved|Owner name: THERANOS IP COMPANY, LLC (US) |

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2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-10-08| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-09-15| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-12-15| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 06/09/2013, OBSERVADAS AS CONDICOES LEGAIS. |

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2022-01-11| B25F| Entry of change of name and/or headquarter and transfer of application, patent and certif. of addition of invention: change of name on requirement|Owner name: THERANOS IP COMPANY, LLC (US) Free format text: A FIM DE ATENDER A ALTERACAO DE NOME REQUERIDA ATRAVES DA PETICAO 870210077260 DE 23/08/2021 E NECESSARIO ANEXAR MAIS UMA GRU 248 REFERENTE A ALTERACAO DE SEDE ANALISADA E ESCLARECER A DIVERGENCIA ENTRE O ENDERECO DO DEPOSITANTE ?LABRADOR DIAGNOSTICS LLC? CONSTANTE NO FORMULARIO E NA DOCUMENTACAO APRESENTADA. |

优先权:

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申请号 | 申请日 | 专利标题

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US201261697797P| true| 2012-09-06|2012-09-06|

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US61/697,797|2012-09-06|

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