• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    ventilated blood collection device. an extravascular system is disclosed. the system includes a body, a septum, a septum activator, and a blood collection device. the body has an internal lumen extending through it. the septum is disposed within an internal lumen. the septum activator is disposed within the inner lumen close to the septum. the septum activator has an internal passageway extending through it. the blood collection device has a tube that is longer than the length of the septum activator and has a width less than or equal to the width of the internal passage of the septum activator. an interior of the tube is in fluid communication with a reservoir within the blood collection device. a vent is in fluid communication with the reservoir. the ventilation passes air but not blood through there.
    公开号:BR112013001050B1
    申请号:R112013001050-9
    申请日:2011-07-12
    公开日:2021-07-13
    发明作者:Jonathan Karl Burkholz
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    BACKGROUND
    [001] The present disclosure refers to the processes of air exhaustion and blood collection with vascular access processes. Blood collection is a health procedure involving taking at least one blood sample from a patient. Blood samples are commonly taken from hospitalized patients, home care, and in emergency rooms either by finger prick, puncture, or venipuncture. Once collected, blood samples are analyzed using one or more levels of blood testing.
    [002] Blood tests determine the patient's physiological and biochemical states, such as disease, mineral content, drug efficacy, and organ function. Blood tests can be performed in a laboratory, a distance from the patient's location, or performed at the place of care, close to the patient's location. An example of a blood testing point of care is a patient's routine blood glucose level testing, which involves drawing blood through a finger prick and mechanically collecting blood into a diagnostic cartridge. After that, the diagnostic cartridge analyzes the blood sample and provides the doctor with a reading of the patient's blood glucose level. Other devices are available that analyze blood gas electrolyte levels, lithium levels, and ionized calcium levels. In addition, some point-of-care devices identify markers of acute coronary syndrome (ACS) and deep vein thrombosis/pulmonary embolism (DVT/PE).
    [003] Despite the rapid advancement in point of care testing and diagnostics, blood collection techniques have remained relatively unchanged. Blood samples are often taken using hypodermic needles, or vacuum tubes attached to the proximal end of a needle or mounted catheter. In some cases, doctors collect blood from a catheter assembly using a needle and syringe that is inserted into a catheter to draw blood from a patient through the inserted catheter. These procedures use needles and vacuum tubes as intermediate devices from which collected blood is typically drawn prior to testing, these procedures are therefore intensive devices, using multiple devices in the process to obtain, prepare and test blood samples . In addition, each device required adds time and cost to the testing process. Therefore, there is a need for more efficient blood collection and testing methods and devices. SUMMARY
    [004] The present invention has been developed in response to problems and needs in the art that have not yet been fully resolved by currently available vascular access methods and systems. Thus, these systems and methods are designed to provide a blood collection device that can vent air from an extravascular system and simultaneously collect a blood sample. In some embodiments, a blood collection device replaces previous devices and procedures that take more time, more parts used, and cost more than the present blood collection device.
    [005] In one aspect of the invention, an extravascular system comprises: a body having an internal lumen extending therethrough; a septum disposed within an internal lumen; a septum activator disposed within the inner lumen near the septum, the septum activator having an internal passageway extending therethrough; and a blood collection device having a tube that is greater than the length of the septum activator and having a width less than or equal to the width of the internal passageway of the septum activator, an interior of the tube being in fluid communication with a reservoir inside the blood collection device, an exhaust in fluid communication with the reservoir, the exhaust passing air but not blood through it.
    [006] An implementation may include one or more of the following features. The blood collection device tube can selectively extend through the internal passage of the septum activator and through an opening in the septum, the blood collection device can be selectively attached to the body. The septum may divide and substantially seal a distal chamber of the inner lumen from the proximal chamber of the inner lumen, and the septum may have one or more openings therein, the septum activator being movable from an unactivated position in the proximal chamber to an activated position that extends through the septum opening into the distal chamber. The blood collection device may have a portion of an outer geometry approximately equal to that of the body's inner lumen so that the blood collection device can be press-fitted into the body's inner lumen. The blood collection device may have a Luer connector that selectively locks with a Luer connector disposed on the body. The body can form a fluid-tight connection that circumscribes the septum. The reservoir can have a volume equal to or greater than about 0.1 ml. The tube may have a length greater than or equal to about 5 mm and a width less than or equal to about 3 mm. At least a portion of the blood collection device defining the reservoir may be compressible and may decrease the internal volume of the reservoir when compressed.
    [007] In another aspect of the invention, the blood collection device comprises: a body defining a reservoir there; a tube extending from the body a distance greater than the length of a septum activator of a blood control valve, the tube having a width less than the internal width of the passage within the blood control valve, the interior of the tube being in fluid communication with the reservoir; and an exhaust coupled to the body and forming a barrier surface of the reservoir, the exhaust passing air but not blood therethrough.
    [008] The implementation may include one or more of the following features. The reservoir can have a volume equal to or greater than about 0.1 ml. The exhaust can be both air-permeable and hydrophobic. At least a portion of the body defining the reservoir may be compressible and may decrease the internal volume of the reservoir when compressed. The tube can have a length greater than or equal to 5 mm.
    [009] In another aspect of the invention, an extravascular system comprises: a body having an internal lumen; a septum is disposed within an inner lumen; a septum activator is disposed within the inner lumen near the septum; a septum activator disposed within an inner lumen near the septum, the septum activator having an internal passageway extending therethrough; and a blood collection device disposed at least partially within the internal lumen of the body, the blood collection device having a tube extending through the internal passage of the septum activator and through an opening in the septum, the blood collection device having a reservoir there in fluid communication with the tube and an exhaust in fluid communication with the reservoir, the exhaust passing air but not blood through it.
    [010] An implementation may include one or more of the following features. The septum can be divided and substantially seals a distal chamber of the inner lumen from the proximal chamber of the inner lumen, and the septum may have one or more openings there, the septum activator being movable from an unactivated position in the proximal chamber to an activated position which extends through the opening of the septum into the distal chamber. A removable seal can be arranged across the hood preventing air from passing through the hood. The blood collection device can be detachably attached to the body. The septum and body can form a fluid-tight connection that circumscribes the septum.
    [011] These and other features and advantages of the present invention may be incorporated into certain embodiments of the invention and will become more fully apparent from the following description and the appended claims, or may be learned by practicing the invention as set forth below. The present invention does not require that all the advantageous features and all the advantages described herein be incorporated within each embodiment of the invention. BRIEF DESCRIPTION OF THE MANY VIEWS OF THE DRAWINGS
    [012] In order that the manner in which the above and the other features and advantages of the invention are obtained will be readily understood, a more particular description of the invention briefly described above will be provided with reference to the specific embodiments thereof which are illustrated in the attached drawings. These drawings depict only typical embodiments of the invention and are therefore not to be considered as limited to the scope of the invention.
    [013] Figure 1 is a perspective view of an extravascular system comprising a catheter assembly, an intravenous tube with a clamp, a port, and a ventilated blood collection device, according to some modalities.
    [014] Figure 2 is a partial cross-sectional view of a port having a blood control valve and a blood collection device that is separate from the port, according to some embodiments.
    [015] Figure 3 is a partial cross-sectional view of a blood collection device that was inserted into the port, according to some modalities.
    [016] Figure 4 is a cross-sectional view of a port that is accessed by a separate device when the blood collection device is removed from the port, according to some embodiments.
    [017] Figure 5 is a perspective view of a blood collection device being compressed and blood dripping onto the blood test strip, according to some embodiments.
    [018] Figure 6 is a perspective view of a blood collection device, according to some modalities.
    [019] Figure 7 is a perspective view of another blood collection device, according to some modalities. DETAILED DESCRIPTION OF THE INVENTION
    [020] The currently preferred embodiments of the present invention will be better understood with reference to the drawings, where the same reference numbers indicate identical or functionally similar elements. It will be readily appreciated that the components of the present invention, as generally described and illustrated in the figures herein, can be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but merely representative of the currently preferred embodiments of the invention.
    [021] Reference will now be made to figure 1, which illustrates an extravascular system 20 with which a blood collection device 42 can be used. It should be understood that the blood collection device 42 is not limited to use within this illustrated extravascular system, but can be used with other extravascular systems ranging from a simple needle to more complex extravascular devices. The blood collection device 42 can, in some configurations, reduce the number of components required to make a diagnosis of a patient's blood sample. This is because the blood collection device 42 combines the ability to perform the processes of ventilating the extravascular system 20 and blood collection in a single device. Additionally, in some cases, blood collection device 42 and port 40 may remove the need for a clamp 38, as described below.
    [022] Figure 1 illustrates an extravascular system 20, such as the BD NEXIVA™ Closed Intravenous (IV) Catheter System, by Becton, Dickinson and Company, which can be accessed by a blood collection device 42. The illustrated modality of the system 20 includes a multiple vascular access device such as a needle hub 26 coupled to a needle introducer 32 that extends through a catheter assembly 24. Catheter assembly 24 includes a catheter adapter 28 that is coupled to a peripheral IV catheter over needle 30 extending therethrough. Needle introducer 32 is left within catheter assembly 24 until catheter 30 is inserted into proper positioning within the patient's vessels, when it is withdrawn. In some embodiments, one or more needle tip protectors 22 are incorporated into the needle hub 26 to protect the needle introducer tip 32 after it is removed from the catheter assembly 24.
    [023] In some configurations, an integrated extension tube 36 is coupled to and provides fluid communication with the catheter assembly 24. Extension tube 36 may also be coupled to a port 40 that provides access to the patient's vascular system through the extension tube 36 and catheter assembly 24. Port 40 can have various configurations, such as a port Luer adapter, a Luer Y adapter, and other known ports. In some cases, a clamp 38 is used to selectively close the extension tube 36 to prevent flow therethrough. As shown, a blood collection device 42 can be coupled to any port 40 in a fluid connection with a patient's vessels. Such alternate ports may be located on catheter assembly 24 directly, or more specifically on catheter adapter 28. In other extravascular systems 20, ports 40 may be coupled to a needle introducer 32, a catheter 30, or other system components. extravascular 20.
    [024] In some embodiments, the blood collection device 42 vents the air from the catheter assembly 24 and the extension tube 36 before collecting the blood sample therefrom. When catheter assembly 24 establishes fluid communication with a patient's vessels, internal blood pressure of the vascular system can force blood into catheter assembly 24 and up extension tube 36. In some cases, this is desirable allowing this blood to fill catheter assembly 24 and extension tube 36 to vent air from extravascular system 20 before fluids are infused through this system into the patient. This process can reduce the likelihood that air will be infused into the patient's vessels.
    [025] Therefore, in some embodiments, the blood collection device 42 includes an exhaust 44 that is permeable to air, through which air from within the extravascular system 20 passes. In some embodiments, exhaust 44 is configured to pass air but not blood. In some embodiments, blood entering the extravascular system 20 forces air out of the exhaust 44 as it enters the extravascular system 20 and fills it into the exhaust 44 of the blood collection device 42. At this time, in some cases, the clamp 38 can close extension tube 36 while blood collection device 42 is removed and a separate vascular access device such as an IV line coupled to a fluid reservoir is coupled to port 40 to begin an IV therapy process. In some cases, as described below, a clamp 38 is not required to prevent blood flow out of port 40.
    [026] As described below, the blood collection device 42 includes an exhaust 44 that can allow air but not blood to pass therethrough. The hood 44 can include various materials and components that provide these properties. For example, in some embodiments, the exhaust 44 includes a glass, a polyethylene terephthalate (PET), a microfiber material, and/or a synthetic material made from high-density polyethylene fibers, such as DuPont's TYVEK® material. Exhaust 44 can be hydrophobic or hydrophilic. Other such materials and components can also be used as an exhaust layer or as a complete exhaust to enable exhaust 44 to be hydrophobic and/or air permeable, in accordance with some configurations.
    [027] In an additional air exhaust of the extravascular system 20, the blood collection device 42 can collect a blood sample there that can be used for blood testing or other procedures. Therefore, in some embodiments, blood collection device 42 includes a reservoir (shown in Figure 2 as 94) therein that can collect blood during the ventilation process and retain the blood after blood collection device 42 is removed from the port. 40. In some configurations, reservoir 94 has an internal volume of between about 0.1 ml to about 10 ml. In other configurations, reservoir 94 has an internal volume of between about 1 ml to about 5 ml. In still other configurations, reservoir 94 has an internal volume of which is greater than 10 mL. Because different blood tests require different amounts of blood, in some modalities, reservoir 94 is sized to hold an amount of blood needed for a specific blood test or for a specific number of blood tests. In some embodiments, a configuration of blood collection devices 42 is provided for a physician having multiple blood collection devices 42 of different sizes.
    [028] Reference will now be made to figure 2, which depicts a cross section of port 40 and blood collection device 42, according to some modalities. As shown, port 40 comprises a body 70 having a lumen 66 extending therethrough. Lumen 66 includes a proximal lumen opening 76 at the proximal end 78 of body 70 into which blood collection device 42 can be inserted. Proximal end 78 of body 70 may also include one or more Luer taps 72 which may allow a male Luer connector, such as a male Luer connector 134 of Figure 7, to connect proximal end 78 of body 70. At distal end 80 of the body 70 extension tube 36 can be connected and aligned in fluid communication with lumen 66.
    [029] As shown, in some configurations, port 40 includes a blood control valve, which is a type of valve that includes a septum 50 and a septum 52 activator. The septum 52 activator selectively pierces through the septum 50 to activate, or open, septum 50. Septum activator 52 is moved distally through septum 50 when a separate device 110 is inserted through proximal lumen opening 76 and forces septum activator 52 distally, as shown in Figure 4. The process of piercing septum 50 with the septum activator 52 is partially illustrated in Figure 5. Once the septum 50 is pierced, fluid can be infused through the septum 50. Unlimited examples of ports 40 having a blood control valves therein are described in U.S. Patent Application Serial No. 13/042,103 filed March 7, 2011, entitled SYSTEM AND METHOD FOR PROVIDING A FLUSH CATHETER ASSEMBLY, (here the "Full Catheter Assembly reference which is incorporated by reference in its entirety. In some configurations, port 40 may have any of the various blood control valve configurations described in the Flushable Catheter Assembly reference. The Flushable Catheter Assembly reference and the patents which it claims priority (which are also incorporated herein by reference in their entirety, and refer to "Relative References") is also described the use of a blood control valve in a catheter assembly 24. While the use of a blood collection device 42 is generally described herein as being used with a port 40 having a blood control valve within an internal lumen 66 of the body 70 of port 40, it should be understood that the blood collection device 42 may, in some configurations, additionally or alternatively be used with a catheter assembly 24 having a blood control valve within the inner lumen of the catheter assembly body 24. Therefore, in some configurations, the various modalities of the blood collection device 42 as described herein can be used with any of several configurations of blood control valves in one assembly. of catheter described in the Flushable Catheter Assembly reference and in the Parent References.
    [030] As shown in Figure 2, in some configurations, the blood control valve of port 40 includes a septum 50 disposed within a groove 74 in the inner lumen 66 of the body 70. In some cases, one or more exhaust channels are disposed between the septum 50 and the body 70 to provide an air channel to be vented around the septum 50, as described in the Flushable Catheter Assembly reference. One or more channels can be used to vent air from the extravascular system 20. In other cases, there are no exhaust channels between the septum 50 and the body 70, but an airtight connection is formed at this interface 54. The fault of exhaust channels can prevent air or blood from flowing around the septum 50. In some cases, air can be vented from the extravascular system 20 through the exhaust 44 of the blood collection device 42.
    [031] In some configurations, the septum 50 may also serve to divide the inner lumen 66 into a distal chamber 82 and a proximal chamber 84 and provide a seal between these two chambers. A septum activator 52 may be disposed in the proximal chamber 84. In some embodiments, the septum activator 52 has an internal passageway 64 extending therethrough. The septum activator 52 may have one or more flow bypass channels 58 formed therethrough which allow fluid flow between the outside areas of the septum activator 52 in the internal passage 64 to provide levelability within the internal lumen 66 and within. of the septum activator 52.
    [032] Figure 2 further depicts a blood collection device 42 that can be inserted into port 40 to vent air from extravascular system 20 while passing the function of septum activator 52. In some configurations, a tube 90 from the collection device blood 42 extends out of its body 92 over a distance sufficient to pass fully through and pass septum activator 52 when blood collection device 42 is connected to port 40. Thus, in some cases, length 100 of the tube 90 is greater than the length 60 of the septum activator 52. Additionally, in some cases, a width 104 of the tube 90 is less than the internal width 62 of the internal passage 64 of the septum activator 52. This tube 90's dimensions can allow it to be inserted through the internal passage 64 of the septum activator 52 and pierce through the septum 50 without housing within and advancing the septum activator 52 forward. Therefore, in some configurations, the outer geometry of the tube 90 approximates or is less than the geometry of the inner passage 64 when the tube 90 is fully inserted through the inner passage 64. Thus, for example, if the inner passage 64 tapers. if from the largest diameter to the smallest diameter, the outer geometry of tube 90 may also taper from the largest diameter to the smallest diameter or otherwise be smaller than the geometry of the inner passage 64. Therefore, the outer geometry of the tube 90 it can be shaped and sized in various configurations to fit the inner passage 64 of the septum activator 52 when the tube 90 is fully inserted into the inner passage 64.
    [033] Reference will now be made to figures 2 and 3, in some embodiments, the blood collection device 42 can be fitted by pressing into the proximal lumen opening 76 of the inner lumen 66 of port 40. This connection can prevent air and blood leaks out of port 40. This connection is formed between the distal portion 102 of the body 92 of the blood collection device 42 and the proximal portion of the inner lumen 66 of the port 40. In some configurations, the outer geometry of the distal portion 102 approximates the inner geometry of the proximal portion of the inner lumen 66. In some configurations, these geometries are substantially circular and the outer diameter 98 of the distal portion 102 is approximately equal to the inner diameter 68 of the proximal portion of the inner lumen 66. In this and other configurations, the blood collection device 42 may press fit into the proximal lumen opening 76 of the port 40. In other configurations, as shown in Figure 7, the collet device Blood eta 42 connects to port 40 through a screw-on Luer connection rather than a press-in connection. Also, other types of connections can be incorporated between blood collection device 42 and port 40.
    [034] In continuous reference to figures 2 and 3, the blood collection device 42 has a body 42 that defines a reservoir 94 therein that can be used to collect and retain a blood sample. When blood collection device 42 is fully inserted into port 40, the distal end of tube 90 extends through one or more slits 56 in septum 50. Thereby, by breaking septum 50, an air passage is created through the interior. 96 of the tube 90, through the reservoir 94, and out of the exhaust 44. The exhaust 44 may be in fluid communication with the reservoir 94 so that air can flow in the reservoir 94 and out of the exhaust 44. This air passage may allow that air be vented from extravascular system 20. In some configurations, septum 50 may contact the outer surface of tube 90 and prevent or substantially prevent air and blood from flowing between tube 90 and septum 50.
    [035] As described above, as air is vented from extravascular system 20, blood flows into the system and fills or substantially fills reservoir 94. After a physician recognizes that extravascular system 20 is vented and reservoir 94 has collected a sample of blood, the physician may remove the blood collection device 42. As the tube 90 of the blood collection device 42 is withdrawn closely through the septum 50, one or more slits 56 of the septum 50 close sealing the proximal chamber 84 from the distal chamber. 82 and the blood contained there. As mentioned above, in some cases, a clamp 38 is not necessary as the blood control valve can automatically seal port 40 before and after blood collection device 42 is inserted into port 40.
    [036] Referring now to Figure 4, after the blood collection device 42 is removed from port 40 a separate device 110 can be coupled to port 40 to infuse a fluid through port 40 into extravascular system 20. In some cases , the separation device 110 is a vascular access device, such as an intravenous fluid line. In some configurations, detachment device 110 includes a male Luer connector 134 that connects to the female Luer taps 72 of port 40. As shown, detachment device 110 is inserted into port 40, a probe member 114 of the device. separation 110 contacts septum 52 activator, forcing it forward through septum 50, opening septum 50. With septum 50 open, fluid can be infused through port 40 into extravascular system 20.
    [037] Referring now to figure 5, after the blood collection device 42 is removed from port 40, the collected blood 126 can be used for analysis and testing. Therefore, in some embodiments, blood collection device 42 is configured to eject at least a portion of blood 126 from reservoir 94. For example, in some embodiments, blood collection device 42 has a body 92 with a compressible portion 120. A compressible portion 120 may include any means for reducing the size of the volume of the reservoir in order to eject a fluid sample into the reservoir 94. For example, the compressible portion 120 may comprise the entire body 92 being flexible or semi-flexible. Or the compressible part 120 can be limited to a limited part of the body 92, which flexes. In a non-limiting example, a compressible part 120 is disposed between two or more rigid parts such that the compressible part 120 compresses when the more rigid parts are pressed in 128. In some embodiments, to facilitate compression and tightening , body 92 includes ridges or other gripping members 122.
    [038] In some embodiments, the blood collection device 42 is configured to eject blood 126 when compressed and retain blood 62 when not compressed. As such, as the blood collection device 42 is withdrawn from port 40 it retains blood there (unless it is compressed), which prevents the physician from exposing blood by removing the blood collection device 42. Thus, in some configurations , the internal dimensions of tube 90 and/or the dimension of open tube 124 is shaped and sized to retain blood 126. Blood retention within tube 90 is governed, at least in part, by the inner perimeter of tube 90, the surface tension of the blood, and the force on the blood 126 to flow out of the open distal tube 124. Therefore, the inner perimeter of the tube 90 can be designed so that the blood 126 is retained within the reservoir 94 when the force of the blood 126 to flow out of the opening of the distal tube 124 is within a certain range, but allows at least some blood to flow out when the pressure in blood 126 exceeds this range.
    [039] For example, in some cases, the inner dimensions of tube 90 are substantially circular and the inner perimeter is less than or equal to approximately 2.0 mm with a diameter 60 less than or equal to approximately 0.6 mm . In these cases, the tube 90 allows the retention of blood against approximately the force of gravity. When the force on blood 126 is greater than the force of gravity some blood 126 may flow out of the open distal tube 124. In other cases, an open circular distal tube 124 with a diameter of about 0.3 mm may retain the blood 126 there against forces stronger than gravity, such as pumping, shock, and movement of the filled blood collection device 42. When the open distal tube 124 has a very small internal perimeter, the force required to expel the blood 126 may be too big.
    [040] Thus, in some embodiments, the inner perimeter of tube 90 has an inner perimeter greater than or equal to about 0.3 mm, which when the inner perimeter of tube 90 is an open circle, corresponds to a diameter of about 0.1 mm. Thus, in some configurations, the inner perimeter of tube 90 is approximately circular and has a diameter between about 0.1 mm to about 0.6 mm. In other embodiments, the inner perimeter of tube 90 is not circular.
    [041] To eject blood 126 from the blood collection device 42, the compressible part 120 or compressible parts 120 can be compressed. This compression decreases the volume and increases the internal pressure of reservoir 94. As the internal pressure it increases and becomes greater than the forces preventing blood 126 from flowing out of tube 90, thereby causing blood 126 spill out of tube 90. The amount of blood 126 that is ejected from distal tube opening 124 may depend on the amount of force applied to compressible part 120. Blood 126 may be ejected into a blood test strip 130, in a cartridge diagnostic device, or on another type of blood test/analysis device.
    [042] Figures 6 and 7 are now discussed. These figures depict specific modalities of a blood collection device 42. Figure 6 depicts a blood collection device 42, similar to that of Figures 2 and 3 which can be fitted by pressing into the opening of the proximal lumen 76 of port 40. As shown, body 92 includes one or more compressible portions 120 and a recessed grip 130. The recessed grip 130 provides a visual and tactile indication of where the finger can be placed to effectively squeeze and compress the compressible portion 120. In some cases, another recessed grip is disposed on the opposite side of the body 92.
    [043] Figure 7 depicts a blood collection device 42 that can be interlocked with the Luer taps 72 of port 40. In some configurations, as shown, body 92 includes an alternative distal body portion 132 comprising a connector Male screw-on Luer connector 134. This male screw-on Luer connector 134 can interconnect with the female Luer connector 72 of port 40 to interlock blood collection device 42 there. This interconnect can provide additional strength and stability over other types of connections.
    [044] From the foregoing, it will be seen that these systems and methods are developed to provide a blood collection device 42 that vents the air from the extravascular system 20 and simultaneously collects a blood sample 126. In some embodiments, a blood collection device blood collection 42 replaces previous devices and procedures that take more time, more parts used, and cost more than the present blood collection device. Blood collection device 42 can be inserted into port 40, left there while it is automatically collected within its internal reservoir 94.
    [045] The present invention may be incorporated in other specific forms without departing from its structures, methods, or other essential features as broadly described herein and claimed below. The modalities described are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is therefore indicated by the appended claims, rather than the above-mentioned description. All changes that come within the meaning and equivalence proportion of the claims are to be covered within its scope.
    权利要求:
    Claims (17)
    [0001]
    1. An extravascular system (20) comprising: a body (70) having an internal lumen (66) extending therethrough; and a blood collection device (42); CHARACTERIZED by a septum (50) disposed within the inner lumen (66); a septum activator (52) disposed within the inner lumen (66) near the septum (50), the septum activator (52) having an internal passageway (64) extending therethrough; and the blood collection device (42) having a tube (90) that is greater than a length (60) of the septum activator (52) and having a width (104) less than or equal to the width (62) of the passageway. an interior (64) of the septum activator (52), an interior (96) of the tube (90) being in fluid communication with a reservoir (94) within the blood collection device (42), an exhaust (44) in fluid communication with the reservoir (94), the exhaust (44) passing air but not blood through it.
    [0002]
    2. Extravascular system (20), according to claim 1, CHARACTERIZED by the fact that the tube (90) of the blood collection device (42) selectively extends through the internal passage (64) of the septum activator (52) and through a slit (56) in the septum (50), the blood collection device (42) being selectively coupled to the body (70) and/or wherein the tube (90) has a length (100) greater than or equal to about 5 mm and a width (104) less than or equal to about 3 mm.
    [0003]
    3. Extravascular system (20) according to claim 1, CHARACTERIZED by the fact that the septum (50) divides and substantially seals a distal chamber (82) of the inner lumen (66) from a proximal chamber (84) of the lumen internal (66), the septum (50) having one or more slits (56) therein, the septum activator (54) being movable from a deactivated position in the proximal chamber (84) to an activated position extending through the slit ( 56) of the septum (50) into the distal chamber (82).
    [0004]
    4. Extravascular system (20), according to claim 1, CHARACTERIZED by the fact that the blood collection device (42) has a part of an external geometry approximately equal to that of the internal lumen (66) of the body (70) such that the blood collection device (42) can be press-fitted into the inner lumen (66) of the body (70), wherein the blood collection device (42) has a Luer connector that selectively interlocks with a Luer connector disposed on the body (70).
    [0005]
    5. Extravascular system (20), according to claim 1, CHARACTERIZED by the fact that the body (70) is both a catheter assembly (24) and a Luer access port (40) and/or in which the septum (50) and the body (70) form a fluid tight connection that circumscribes the septum (50).
    [0006]
    6. Extravascular system (20), according to claim 1, CHARACTERIZED by the fact that the reservoir (94) has a volume equal to or greater than about 0.1 mL.
    [0007]
    7. Extravascular system (20), according to claim 1, CHARACTERIZED by the fact that at least a part (120) of the blood collection device (42) defining the reservoir (94) is compressible and reduces the internal volume of the reservoir when compressed.
    [0008]
    8. Extravascular system (20) CHARACTERIZED in that it comprises: a blood control valve, wherein a blood collection device (42) comprises: a body (70) defining a reservoir (94) therein; a tube (90) extending from the body (70) at a distance greater than the length (60) of a septum activator (52) of the blood control valve, the tube (90) having a width (104) less than the that the internal width (62) of the passage (64) within the blood control valve, the interior (96) of the tube being in fluid communication with the reservoir (94); and an exhaust (44) coupled to the body (70) and forming a barrier surface of the reservoir (94), the exhaust (44) passing air but not blood therethrough.
    [0009]
    9. Extravascular system (20), according to claim 8, CHARACTERIZED by the fact that the reservoir (94) has a volume equal to or greater than about 0.1 mL.
    [0010]
    10. Extravascular system (20), according to claim 8, CHARACTERIZED by the fact that the exhaust (44) is permeable to air and hydrophobic.
    [0011]
    11. Extravascular system (20), according to claim 8, CHARACTERIZED by the fact that at least a part (120) of the body (70) defining the reservoir (94) is compressible and reduces the internal volume of the reservoir when compressed.
    [0012]
    12. Extravascular system (20), according to claim 8, CHARACTERIZED by the fact that the tube has a length greater than or equal to 5 mm.
    [0013]
    13. Extravascular system (20) CHARACTERIZED by the fact that it comprises: a body (70) having an internal lumen (66); a septum (50) disposed within the inner lumen; a septum activator (52) disposed within the inner lumen (66) near the septum (50), the septum activator (52) having an internal passageway (64) extending therethrough; and a blood collection device (42) disposed at least partially within the inner lumen (66) of the body (70), the blood collection device (42) having a tube (90) extending through the internal passage (64) of the septum activator (52) and through an opening in the septum (50), the blood collection device (42) having a reservoir (94) therein in fluid communication with the tube (90) and an exhaust (44) in communication fluid with the reservoir (94), the exhaust (44) passing air but not blood therethrough.
    [0014]
    14. Extravascular system (20) according to claim 13, CHARACTERIZED by the fact that the septum (50) divides and substantially seals a chamber (82) distal to the inner lumen (66) from a proximal chamber (84) of the lumen internal (66), the septum (50) having one or more slits (56) therein, the septum activator (52) being movable from a deactivated position in the proximal chamber (84) to an activated position extending through the slit ( 56) of the septum (50) in the distal chamber (82).
    [0015]
    15. Extravascular system (20), according to claim 13, CHARACTERIZED by the fact that it further comprises a removable seal disposed through the hood (44) preventing air from passing through the hood (44).
    [0016]
    16. Extravascular system (20) according to claim 13, CHARACTERIZED by the fact that the blood collection device (42) is detachably coupled to the body (70).
    [0017]
    17. Extravascular system (20), according to claim 13, CHARACTERIZED by the fact that the septum (50) and the body (70) form a fluid-tight connection that circumscribes the septum (50).
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-05-25| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-07-13| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/07/2011, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |
    优先权:
    申请号 | 申请日 | 专利标题
    US36445510P| true| 2010-07-15|2010-07-15|
    US61/364,455|2010-07-15|
    PCT/US2011/043682|WO2012009338A1|2010-07-15|2011-07-12|Vented blood sampling device|
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