medication delivery device for use with a medication container, kit comprising a sterile pocket wrap

专利摘要:
MEDICINE INJECTION FIELD AND DATA COLLECTION SYSTEM. The present invention relates to a medication delivery device for use with a medication container that includes a housing, with fluid conduit at least partially extending into the housing and configured to send the medication into the medication container to a patient, a medication port extending from the housing and configured to be coupled to a fluid outlet of the medication container, the medication port being coupled to a fluid outlet of the measuring container, the measurement port being attached fluidly to the fluid conduit and at least one sensor arranged inside the housing to generate information that characterized the administration of the medication for processing by a remote data collection system. The housing may have a size and shape that allows it to be supported by a user's first hand while the user administers medication from the medication container through the medication port using the user's second hand. Related devices, systems, kits, and techniques are also described.
公开号:BR112012010782B1
申请号:R112012010782-8
申请日:2010-11-03
公开日:2020-11-10
发明作者:Walter John Bochenko；Shawn Wayne Dekalb；Winthrop De Childers；Stephen Michael Prince
申请人:Crisi Medical Systems, Inc.；
IPC主号:

专利说明:

Related Orders
[0001] This application claims priority over each of the following applications which are all entitled "Medication Injection Field and Data Collection System": US patent application serial number 12 / 938,300 filed on November 2, 2010; US patent application serial number No. 12 / 765,707 filed April 22, 2010; US patent application serial number No. 12 / 614,276 filed on November 6, 2009; and US patent application serial number No. 61 / 370,974 filed on August 5, 2010. The contents of all such applications are hereby incorporated by reference in their entirety. Field
[0002] The subject described here refers to a field of drug injection for the intelligent delivery of medications in a fluid path for delivery to a patient as well as the related data collection systems. Background
[0003] Several health care procedures involve medication administrations. The type of medication and administration schedule are important to record in order to provide health care professionals with real-time information on conducting the procedure and completing the medical record. Some protocols require rapid medication administration with limited time for documentation and record keeping. Others need to complete and verify medication administration manually to ensure adequate patient care and accountability for the use of medications. summary
[0004] Various systems, devices, kits, articles, and methods are provided as mentioned in the claims.
[0005] In one aspect, a medication delivery device for use with a medication container is provided. The apparatus may include a housing, a fluid conduit at least partially extending into the housing and configured to send medication within the medication container to a patient, a medication port extending from the housing and configured to be coupled to a fluid outlet from the medication container, the medication port being fluidly coupled to the fluid conduit; and at least one sensor arranged inside the housing to generate information that characterizes the administration of the medication for processing by a remote data collection system. The housing can be of a size and shape that allows it to be supported by a user's first hand while the user administers medication from the medication container through the medication port using the user's second hand.
[0006] In another aspect, a medication field is provided which includes a housing, a junction element, a medication port, one or more medication sensors, a transmitter, and a self-contained energy source. The coupling member can at least partially extend within the housing to form a first fluid channel and a second fluid channel. The first fluid channel extends from the first end to the second end. The first end can be configured to be coupled to a fluid source. The second end of the first fluid channel can be configured to form a fluid outlet from the drug injection field to allow coupling to a parenteral fluid delivery access device (e.g., intravenous, intraosseous, intraarterial access device , intramuscular, subcutaneous).
[0007] The second fluid channel extends from a distal end and ends at the first fluid channel at an intermediate intersection at the first end and the second end. The medication port is fluidly coupled to the distal end of the second fluid channel and is configured to be fluidly coupled to a fluid outlet from a medication container. The identification sensor is arranged within the housing to generate information indicative of the contents of the medication container when the fluid outlet from the medication container is fluidly coupled to a medication port. The transmitter is arranged inside the housing and in communication with the identification sensor to wirelessly transmit the information generated by the identification sensor to a remote data collection system. The term transmitter in the present context can refer only to a transmitter or to a transceiver, a combined transmitter - receiver (unless otherwise specified). The self-contained energy source is arranged inside the housing and it activates components within the medicine injection field such as the identification sensor and the transmitter. In some implementations, the housing has a shape and size allowing it to be maintained by a user's first hand while the user administers medication from the medication container through the medication port using his second hand.
[0008] In an additional aspect, a drug injection field is provided that includes a separate housing from and does not include the first fluid channel or a coupling element. In said implementation, the second fluid channel becomes the only fluid channel. The housing includes a medication port, an identification sensor, a transmitter and a self-contained power source. The medication port is fluidly coupled to the distal end of the second fluid channel and can be configured to be fluidly coupled to a fluid outlet from a medication container. The proximal end of the second channel can be configured to form a fluid outlet from the drug injection field to allow direct coupling to a parenteral fluid delivery access device (e.g., intravenous, intraosseous, intraarterial access device , intramuscular, subcutaneous) with little or no intermediate tube (for example, 10 cm or less, etc.). Examples of direct coupling may include, but are not limited to, connection to a "Y" field of a tube assembly, a patient catheter, an intraosseous access device or a needle for direct injection of fluid.
[0009] The largest dimension of the housing may, in some implementations, be less than or equal to 10 centimeters. Additionally or alternatively, a weight of the system may be less than or equal to 500 grams, and in some implementations, less than or equal to 250 grams, and in other implementations less than or equal to 100 grams. In still additional implementations, the weight may be ultralight weight and be less than 50 grams.
[00010] The first end of the first fluid channel can be fluidly coupled to a tube extending to a fluid source. The fluid source can be suspended (eg, IV drip bag, etc.) and the fluid contained therein can be fed by gravity through the tube inside the first channel. With said variation, the housing can be suspended below the fluid source and supported by the tube during use. The second end of the first fluid channel can be fluidly coupled to a patient. In other variations, the housing can be located downstream more closely associated with the patient's catheter.
[00011] A self-contained fluid delivery sensor can be arranged inside the housing and in communication with the transmitter to characterize fluid flow through one or more of the first fluid channel and the second fluid channel. With these arrangements, the transmitter can transmit wireless data that characterizes fluid delivery to the remote data collection system. The fluid delivery sensor can measure fluid flow, volume, medication or composition and / or fluid type pressure in the first fluid channel. Alternatively or In addition, the fluid delivery sensor measures fluid flow, volume, medication or composition and / or fluid type pressure in the second fluid channel. The fluid delivery sensor can be either a pressure sensor, a differential pressure sensor, an optical sensor, an ultrasonic sensor, a chemical sensor, a conductivity sensor, a medication composition sensor, a displacement sensor or a fluid flow sensor or a combination of said or other fluid sending sensors.
[00012] In some implementations, a medication composition sensor can be used in order to check and / or determine the contents of the medication container. A medication composition sensor can automatically determine the composition of the injected medication from the medication container. The same can be a sensor or a plurality of sensors that determines the type of fluid being injected. This can be compared to the type of medication indicated by the medication ID code, if present. The sensor can be any one or more of a pH detector, a viscosity indicator, an optical density indicator, a chemical indicator, a drug molecule indicator, a drug sensor, a spectrophotometer, an HPLC detector, a UV detector, fluid density sensor, fluid specific gravity sensor, etc.
[00013] The coupling member may contain a diaphragm portion along one or more of the first fluid channel and the second fluid channel and the fluid delivery sensor can be positioned adjacent to the diaphragm.
[00014] The remote data collection system can calculate the volume of fluid sent through the medication port based on the wirelessly transmitted data that characterizes the fluid delivery. Alternatively, or In addition, the volume of fluid sent can be calculated locally within the medication port housing and said volume data can be transmitted wirelessly to the remote data collection system.
[00015] The self-contained energy source can be arranged inside the housing to activate one or more of the identification sensor, the fluid sending sensor, and the transmitter.
[00016] An intersection of the first fluid channel and the second fluid channel can form a substantially T-shaped junction. In other variations, an intersection of the first fluid channel and the second fluid channel can form a substantially shaped junction. of Y.
[00017] The medication port may define a cavity extending inwardly from an outer surface of the housing so that the fluid outlet from the medication container is substantially enveloped within the housing and does not extend beyond the outer surface when the said fluid outlet is mechanically coupled to the port. The medication port can be a needle-free injection port or a one-way valve port.
[00018] The medication container can carry a source of information that characterizes the medication container and / or its contents. The information source can be, for example, mechanically encoded information, magnetically encoded information, and information read by radio frequency. The information source may also or alternatively comprise optically encoded information and the identification sensor may comprise an optical emitter and an optical detector for reading the optically encoded information. The identification sensor may include an optical LED emitter to illuminate the information source and an optical detector such as a camera (coupled charge device - CCD). The identification sensor can read information from an information source as a result of the relative movement of the fluid outlet from the medication container relative to a medication port. The identification sensor can read information from the information source in response to mechanically coupling the fluid outlet to a medication port.
[00019] The medication container can be a syringe without a needle, and the fluid outlet can be a tip of the syringe. The medication container can be a bottle and the fluid outlet can be the stop at the bottle closure. The medication container can be a premixed solution provided in a bag, and the fluid outlet can be a Luer-type connector or a pierceable IV port. The medication container can be a small disposable, rigid, semi-rigid or flexible envelope that contains medication for administration to a patient and the fluid outlet can be an integral Luer fitting in the container, at the end of the tube attached to the container or part of a fluid transfer device used with medication vials. The medication container can be a set of fluid delivery tube and the fluid outlet can be an integral Luer fitting on the tube end attached to the container.
[00020] The joining element can be a unitary injection molded fitting.
[00021] The medication can be intermittently sent through the medication port so that it is continuously or substantially continuously sent to the first fluid channel through the first end of the first fluid channel. Alternatively, the medication can be sent intermittently through the medication port so that it is only sent to the second fluid channel.
[00022] A first safety valve can be disposed within the first fluid channel intermediate the intersection and at the first end of the first fluid channel to prevent the fluid sent into the medication port from leaving the first fluid channel at the first end . A second safety valve can be disposed within the secondary fluid channel to prevent fluid entering the first fluid channel at the first end from leaving the secondary fluid channel at the distal end. The second safety valve can be the needle-free injection port or the one-way valve port.
[00023] The housing can comprise a plurality of sections, and one or more of the first fluid channel and the second channel can be formed when at least two of the sections are assembled. At least two of the housing sections can be injection molded and one or more of the first fluid channel and the second fluid channel can be formed by one or more injection molded sections.
[00024] In one implementation, the drug injection field can be separated into two sub-housings, a reusable sub-housing, a disposable sub-housing that are coupled to each other via an interface connection. The reusable sub-housing can be used by one or more patients while the disposable sub-housing is intended to only be used by a single patient (ie, the components contained within the disposable sub-housing provide a passage of sterile fluid that are separated from the components within reusable sub-housing ensuring patient safety). The reusable sub-housing may contain elements from the drug injection field that are not part of the first fluid channel or the second fluid channel (for example, one or more of the identification sensor (s), the fluid sending sensor, the transmitter, processor, memory, etc.). The disposable sub-housing may contain one or both of the first fluid channel and the second fluid channel. The power source can be positioned in any sub-housing.
[00025] A removable sterility cover can be attached to a medication port. Removing the sterility cover can initiate communications between the transmitter and the remote data collection system.
[00026] A self-contained energy source (for example, battery, battery structure, etc.) can be arranged inside the housing by activating one or more of the medication sensors, the fluid sending sensor, and the transmitter. Removing the sterility cap attached to the medication port can initiate the provision of electricity by the power source to the medication sensors and the transmitter.
[00027] The shape and size of the housing may allow the placement of the housing in the arm or leg of a patient adjacent to an injection field in the patient, positioned in the "Y" field of the fluid delivery tube assembly, connected directly to catheter or attached to a needle for direct injection. The shape and size of the housing may allow placement of the housing in a patient at or near the peripheral venous access field, a central venous line, a subcutaneous access field, an intramuscular access field, or an intraosseous access device.
[00028] A medication port can, in some variations, be arranged entirely or at least substantially entirely within the housing. The medication port can additionally or alternatively be integrated into the junction element.
[00029] A memory element can be arranged inside the housing that can store information obtained from the medication sensors and / or the fluid sending sensor. A programming element can be coupled to the memory element to allow recalling events that correspond to which medication is administered, the time of medication administration, what volume of medication was administered, the duration of medication administration, the identification sensor information from the second source of information and the time of wireless transmission of information generated by the medication sensors. The remote data collection system can wirelessly request the transmitter to send the information stored in the memory element obtained from the sensors. In addition, the remote data collection system may comprise a programming element for assigning schedules to each data record based on the absolute time and duration between recorded transmissions.
[00030] The system can include an identifier (for example, serial number or alphanumeric identifier, barcode label, etc.) to uniquely identify wireless transmissions from the transmitter. The identifier can be encapsulated in some or all wireless transmissions, or it can be manually accessed or read by the technician.
[00031] The medicine injection field can be enveloped in a sterile pocket (ie, enclosure, etc.). The medicine injection field can be part of a kit that also contains instructions for use.
[00032] In a first interrelated aspect, a medication injection field includes a housing, a junction element, a medication port, one or more medication sensors, a transmitter, and a self-contained power source. The coupling element extends at least partially within the housing forming a first fluid channel and a second fluid channel. The first fluid channel extends from the first end to the second end. The second fluid channel extends from a distal end and ends at the first fluid channel at an intermediate intersection with the first end and the second end. The medication port is fluidly coupled to the distal end of the second fluid channel and can be configured to be fluidly coupled to a fluid outlet from a medication container. An identification sensor can be arranged adjacent to the second fluid channel to generate information indicative of the contents of the medication container when the fluid outlet from the medication container is fluidly coupled to a medication port. A second identification sensor can be arranged inside the housing to generate complementary information for the medication information container (for example, information about the patient, about a medication procedure, a medication and / or its preparation, the healthcare professional administering the medication, etc.). The transmitter is arranged inside the housing and in communication with the medication sensors to wirelessly transmit the information generated by the medication sensors to a remote data collection system. The self-contained energy source is arranged inside the housing by activating the medication sensors and the transmitter.
[00033] The activation of the second identification sensor can be manual (manipulation by user, etc.) or automated (the device is activated remotely, etc.). Activation can be through mechanical, electronic, optical, magnetic or remote communication.
[00034] A self-contained fluid delivery sensor can be arranged inside the housing and in communication with the transmitter to characterize fluid flow through one or more of the first fluid channel and the second fluid channel. With this variation, the transmitter can additionally transmit wireless data that characterizes the sending of fluid to the remote data collection system.
[00035] In yet another interrelated aspect, a medicine injection field includes a housing, a medication door extending from an external surface of the housing, an identification sensor disposed within the housing to generate information indicative of the contents of the medication container when the fluid outlet from the medication container is fluidly coupled to a medication port, an identification sensor arranged inside the housing to generate complementary information to the contents of the medication container when the sensor is proximal to the source of complementary information, a transmitter arranged inside the housing and in communication with the medication sensors to wirelessly transmit the information generated by the medication sensors to a remote data collection system. The housing has a shape and size allowing it to be maintained by a user's first hand while the user administers medication from the medication container through the medication port using his second hand.
[00036] In an additional interrelated aspect, an apparatus for identifying the contents of a medication container is provided. Said medication container includes a cylinder portion, a fluid outlet tip, and a tapered portion intermediate the cylinder portion and fluid outlet tip. The apparatus includes an identification member provided with an opening greater than a diameter of the fluid outlet tip and less than or equal to the diameter of the cylinder portion. In other variations the identification member may be relatively larger in diameter than the cylinder portion. The identification member may contain optical, magnetic, and / or mechanically encoded information. The information can be indicative of one or more of the contents of the medication container, the volume of fluid within the medication container, and the expiration date of the contents of the medication container. In addition, information in the identification member can include a unique identifier (such as a serial number, random ID identifier {alphanumeric string, hexadecimal code with or without a prefix, suffix, base code subscription number} or other unique information data , prefix, suffix, symbol or color, etc.), said information can be used to identify the recipient and provide reading through the medication use cycle. The information can be patient-specific or patient-neutral.
[00037] The information may be able to be read by an identification sensor when the identification member is located around the fluid outlet tip and the device is coupled to or adjacent to a fluid delivery system to send contents from the medication container.
[00038] In an additional interrelated aspect, an apparatus (eg, a complementary data sensor, etc.) for identifying complementary information for the medication container can be provided (either integrated into the medication injection field or used in with it). The apparatus may include a second identification member and identification sensor. The second identification member can contain optical elements (one-dimensional barcode, two-dimensional barcode, symbol, image or photo), magnetic elements (magnetic strip on an ID / badge / ID label), RFID, and / or mechanically encoded information. The information can be indicative of one or more of the following: a patient (patient ID, weight, height, sex, age, pre-existing medical conditions, current medical status, Broselow color); a patient sample (sample ID, blood sample, urine sample, tissue sample, stool sample, sample of other body fluid, etc.); a medical device (device ID, IV pump, ECG monitor, defibrillator, pulse oximeter, blood pressure monitor, etc.); a health professional (photo, ID, name, affiliation, etc.); a pharmacy record (prescription, patient ID, medication formulation, preparation date, expiration date, administration instructions and or precautions, pharmacy ID, preparer ID, etc.).
[00039] Said information can be used to associate treatment information with the injection of medication and its use in a particular patient. The information may be able to be read by an identification sensor when the identification member is located proximal to the identification sensor or is coupled to or adjacent to the device.
[00040] In an additional aspect, a drug injection field is provided which includes a separate housing from the first fluid channel. In said variation, the second fluid channel becomes the only fluid channel. The medication port is fluidly coupled to the distal end of the second fluid channel and can be configured to be fluidly coupled to a fluid outlet from a medication container. The proximal end of the second channel can be configured to form a fluid outlet from the drug injection field to allow direct coupling to a parenteral fluid delivery access device. An identification sensor is disposed adjacent to the second fluid channel to generate information indicative of the contents of the medication container when the fluid outlet from the medication container is fluidly coupled to a medication port. A second identification sensor (sometimes referred to as a complementary data sensor, etc.) can be arranged within the housing to generate information complementary to the contents of the medication container when the sensor is proximal to the source of complementary information. The transmitter is arranged inside the housing and in communication with the medication sensors to wirelessly transmit the information generated by the identification sensors to a remote data collection system. In addition, a fluid delivery sensor can be arranged inside the housing and in communication with the transmitter to wirelessly transmit the information generated by a fluid flow / volume sensor to a remote data collection system. The self-contained energy source can be arranged inside the housing by activating the medication sensors, the fluid delivery sensor and the transmitter.
[00041] In yet another aspect, an accommodation can include a reusable sub-housing and a disposable sub-housing. The reusable sub-housing can be operationally coupled to the disposable sub-housing. In addition, reusable sub-housing is intended for use by a plurality of patients and disposable sub-housing is intended for use by a single patient. Said arrangement may also include a medication port configured to be fluidly coupled to a fluid outlet of a medication container, an identification sensor arranged within the housing to generate information indicative of the contents of the medication container when the medication outlet fluid from the medication container is fluidly coupled to a medication port, a transmitter arranged inside the housing and in communication with the identification sensor to wirelessly transmit the information generated by the identification sensor to a remote data collection system, and an energy source disposed inside the housing activating the medication sensors and the transmitter.
[00042] In one implementation, the medication port is inside the disposable sub-housing and one or more of the medication sensors, the transmitter, and the power source are in the reusable sub-housing.
[00043] The identification member can be arranged radially on the central fluid outlet shaft of the fluid outlet tip allowing the detection of information when the medication container is rotated on the central fluid outlet shaft.
[00044] The information can be arranged linearly allowing the detection of information when the medication container is joined with a fluid path along a central fluid outlet axis of the medication container. The information can be selected from a group comprising: optically encoded information, magnetically encoded information, radio frequency detectable information, and mechanically detectable information.
[00045] The medication container can be a first medication container and the identification member can be releasably attached to the medication container to allow it to be removed for disposal in a second medication container. The identification member can carry a fixing element allowing it to be removed from the first medication container and attached to the second medication container. The transfer of the identification member from the first medication container to the second medication container can be completed during the process of transferring the medication from the first medication container to the second medication container.
[00046] The identification member can be a label or other element adhered to, printed on, and / or engraved on the medication container. The identification member can be integral to the medication container. The identification member can be a ring-shaped member configured to fit around the fluid outlet tip. The identification member can be a disk or cup member configured to fit over the fluid outlet tip.
[00047] In another aspect, a system can include a housing, a medication port, a transmitter, and a power source. The medication port is configured to be fluidly coupled to a fluid outlet from a medication container. The identification sensor generates information indicative of the contents of the medication container when the fluid outlet from the medication container is fluidly coupled to a medication port. The transmitter is in communication with the identification sensor to wirelessly transmit the information generated by the identification sensor to a remote data collection system. The remote data collection system can be coupled to or integral with a secondary medical device. The power source can drive the identification sensor and the transmitter.
[00048] The secondary medical device can be, for example, a physiological sensor, a defibrillator, an infusion pump, a ventilator, an anesthesia machine. Examples of physiological sensors include an ECG monitor, an EEG monitor, a blood pressure monitor, an ETC02 monitor, and / or a pulse oximeter. The remote data collection system may also comprise a medication delivery barcode (BCMA) system.
[00049] The data collection system can receive information from one or more fields of drug injection and one or more secondary medical devices. The data collection system can be coupled with or form part of a cell phone or other mobile computing system (for example, tablet computer, IPAD, etc.). The data collection system can provide collected data to other systems (medical information systems, hospital information systems, emergency medical services information systems (EMS), remote monitoring systems, event management systems, information systems home health care monitoring, medication waste disposal management systems, telemedicine systems, etc.) and or receiving information from other systems (medical information systems, remote systems, event management systems, home health care monitoring, medication waste disposal management systems, telemedicine systems, etc.). The data collection system can include a set of rules with alerts and alarms to provide healthcare professionals with information regarding injected medications, to be injected or that need to be discarded / destroyed.
[00050] In addition, in some implementations the housing may comprise at least one fluid characterization sensor. Said at least one fluid characterization sensor can be used to characterize the contents of the medication container and / or administer the contents of the medication container. The at least one fluid characterization sensor may comprise, for example, an identification sensor and / or a fluid characterization sensor.
[00051] In yet an additional aspect, a method is provided in which information is received (for example, by at least one data processor, etc.) from a medication delivery device as described here that characterizes the administration of medication to a patient. Afterwards, the information is associated (for example, by at least one data processor, etc.) with data specifying at least one medication and / or a volume of medication. Once that association has been made, the associated data is promoted (for example, displayed, stored, transported, etc.).
[00052] The subject described here provides many advantages. For example, the current issue allows for compact fluid injection port systems that automatically identify the medication administered and / or determine the volume and / or type of medication administered. The fluid injection port is small enough to be arranged on a standard IV line (and to be self-supporting) allowing it to be used in multiple situations including paramedical treatments in the field, during ambulance transport of patients, as well as medical facilities such as emergency rooms / intensive care units / operating rooms / general care. Additionally, as the medical team (for example, doctors, nurses, paramedics, etc.) are used to sending medicine through Y-fields in IV lines, through catheters and needles, the current issue requires little, if any. some, behavior modification while allowing the intelligent sending of medication and the exploration of administered medications. In addition, the compact nature of the fluid injection port makes the need for a larger bench or cradle unit unnecessary, which can be inconvenient during blue code emergency events or other emergency events and which may require more space needed (displacing other necessary equipment). In addition, the current issue uses a wireless interface and does not require wires to communicate information to the data collection system that could interfere with or complicate patient care activity. In addition, the data received by the data collection system can be actively displayed in real time providing information clearly visible to the medical team keeping everyone informed and up to date. Additionally, the current issue eliminates manual record keeping and other activities that may tend to divert from the necessary attention to a patient. Automated record keeping provides accurate records and frees up time for healthcare professionals by allowing improved patient care. Finally, the current issue is advantageous in the sense that the field of drug injection can be disposable (thereby increasing patient safety).
[00053] The details of one or more variations of the subject described here are determined in the accompanying drawings and in the description below. Other features and advantages of the subject described here will be apparent from the description and the drawings, and from the claims. Description of Drawings
[00054] The attached drawings, which are incorporated into and constitute a part of the present specification, show certain aspects of the subject described here and, together with the description, helps to explain some of the principles associated with the described modalities. In the drawings:
[00055] FIGURE 1 is a diagram illustrating a healthcare provider using a drug injection field in connection with the care of a patient;
[00056] FIGURE 2A is a diagram illustrating a first variation of a drug injection field with a medication port flush with or disposed within a housing cavity;
[00057] FIGURE 2B is a diagram illustrating a second variation of a medication injection field with a medication port extending out of a housing;
[00058] FIGURE 2C is a diagram illustrating a third variation of a medication injection field with a medication port directly connected to a set of "Y" field fluid delivery tube;
[00059] FIGURE 2D is a diagram illustrating a fourth variation of a medication injection field with a medication port directly connected to the needle;
[00060] FIGURE 3A is a diagram that illustrates a detailed view of a drug injection field as in FIGURE 2A;
[00061] FIGURE 3B is a diagram illustrating a side view of a drug injection field as in FIGURE 3A;
[00062] FIGURE 3C is a diagram illustrating an enlarged cross-sectional view of the elements in FIGURE 3B;
[00063] FIGURE 4A is a diagram illustrating a medication injection field with a medication container carrying an alternative information source to that of FIGURE 3A;
[00064] FIGURE 4B is a diagram illustrating a side view of a drug injection field as in FIGURE 4A;
[00065] FIGURE 4C is a diagram illustrating an enlarged view of a medication container provided with an alternative information source as in FIGURES 4A and 4B;
[00066] FIGURE 4D is a diagram illustrating a second enlarged view of a medication container provided with an alternative information source as in FIGURES 4A and 4B;
[00067] FIGURE 5 is a diagram illustrating a drug injection field and a data collection system;
[00068] FIGURE 6A is a diagram illustrating a medication container containing an information source that can be optically detected;
[00069] FIGURE 6B is a diagram illustrating an enlarged view of elements shown in FIGURE 6A;
[00070] FIGURE 7A is a diagram illustrating a medication container containing an information source that has mechanical characteristics;
[00071] FIGURE 7B is a diagram illustrating an enlarged view of elements shown in FIGURE 7A;
[00072] FIGURE 8A is a diagram illustrating a medication container provided with a radial information source as in FIGURE 4A in greater detail;
[00073] FIGURE 8B is a diagram illustrating an alternative location for the source of radial information;
[00074] FIGURE 8C illustrates an enlarged view of elements shown in FIGURE 8A;
[00075] FIGURE 8D is an alternative information source that fits around a portion of a medication container;
[00076] FIGURE 9A is a diagram illustrating a medicine injection field with a first channel of linear fluid intersected by a second channel of fluid at right angles;
[00077] FIGURE 9B is a diagram illustrating a drug injection field with a first fluid channel intersected by a second fluid channel at a right angle and a medication port coupled to the intersection of the first fluid channel and the second channel of fluid;
[00078] FIGURE 9C is a diagram illustrating a drug injection field with a first fluid channel intersected by a second fluid channel at an acute angle;
[00079] FIGURE 10A is a diagram illustrating the fluid delivery tube assembly;
[00080] FIGURE 10B is a diagram illustrating different locations for a fluid delivery tube assembly as in FIGURE 10A;
[00081] FIGURE 11A is a diagram illustrating a drug injection field with a fluid flow measurement sensor in a first fluid channel;
[00082] FIGURE 11B is a diagram illustrating a drug injection field with a fluid flow measurement sensor in a second fluid channel;
[00083] FIGURE 12 is a diagram illustrating a flow measurement calculation method described for use with a drug injection field as in FIGURES 11A and 11B;
[00084] FIGURE 13A is a diagram that illustrates a first pressure-time graph for a flow measurement calculation method as in FIGURE 12;
[00085] FIGURE 13B is a diagram that illustrates a second pressure - time graph for a flow measurement calculation method as in FIGURE 12;
[00086] FIGURE 14A is a diagram illustrating a data collection system with a wireless data receiver and removable memory;
[00087] FIGURE 14B is a diagram illustrating a data collection system with a wireless data receiver, screen, and recording system;
[00088] FIGURE 15A is a diagram illustrating a first variation of the drug injection field that includes a disposable sub-housing and a reusable sub-housing;
[00089] FIGURE 15B is a diagram illustrating a second drug injection field that includes a disposable underheating and a reusable underheating;
[00090] FIGURE 15C is a diagram illustrating a third field of drug injection that includes a disposable underheating and a reusable underheating;
[00091] FIGURE 15D is a diagram illustrating a fourth field of drug injection that includes a disposable sub-housing and a reusable sub-housing;
[00092] FIGURE 16A is a diagram illustrating a secondary medical device configured to receive wireless information from a drug injection field;
[00093] FIGURE 16B is a diagram illustrating a data collection system for receiving wireless information from a medication field and from a secondary medical device;
[00094] FIGURE 16C is a diagram illustrating a data collection system configured as a cell phone to receive wireless information from a drug injection field and / or a secondary medical device; and
[00095] FIGURE 17 is a diagram illustrating a second identification sensor for receiving information from a second information source.
[00096] Similar reference symbols from the various drawings indicate similar or similar elements. Detailed Description
[00097] FIGURE 1 is a diagram illustrating a system 2 in which a health care provider inspects a patient's care. In particular, the healthcare provider selects and administers medications from a stock or structure of available medications. A medication container 20 may carry an information source 24 that provides detectable indicative information about the medication in the container and / or the volume of the contents of the container. After selecting the appropriate medication, the health care provider sends it to the field of medication injection 3. There may be several routes for parenteral medication administration. One can be located in a tube assembly 11 connected to the patient. The tube set is often used to deliver fluids to patients and can provide convenient access for manual injection of medications as well as for controlled infusions. As shown in FIGURE 1, the drug injection field 3 can be positioned at different locations along a tube assembly 11. In some implementations, the location may be close to the fluid source bag (for example, saline bag , etc.) where the drug injection field 3 is fixed to or acts as a "Y" field in the tube set 11. Here, prepared mixtures from the pharmacy can be attached to an IV tube set. Alternatively, the drug injection field 3 may be in the form of an extension set located lower in the tube assembly 11 closest to the patient's infusion field. This field can be used for IV bolus injections where the immediate delivery of medication to the patient is important for acute care situations. Still other forms of medicine injection field 3 can include direct bolus injection to a patient by attaching the medicine injection field 3 to a catheter or needle with little or no intermediate tube (for example, 10 cm or less, etc.). ). Here, the medication is directly injected into the patient through a single fluid channel within the medication injection field 3. Emergency medications, insulin, pain medications can use the said method of administration and are typically followed by a solution rinse saline.
[00098] At any of the locations above the medication injection field, a sensor at least partially inscribed by housing 4 of the medication injection field 3 can detect the presence and type of medication container 20 and transmit information 36 via of wireless communications to the data collection system 6. Medication injections (from one or more medication containers 20) can have time stamped and recorded in a history record and / or added to the patient's medical records and / or billing records. The healthcare provider can see on a screen of the data collection system 6 which medication was injected into the patient and when that medication was administered, the immediate display of information helps the healthcare provider to make additional medication decisions for patient care.
[00099] FIGURES 2A and 2B are a diagram illustrating the medication injection field 3 with medication container 20 in a spatially separate state (FIGURE 2A) and a coupled state (FIGURE 2B). In said variation, the drug injection field 3 may include a first fluid channel 8 and a second fluid channel 10 (other channels may be included in some implementations). The housing 4 of the medicine injection field 3 can include not only the first fluid channel 8 (continuous fluid channel connecting the fluid source to the patient) but also the second channel 10 (injection port fluid channel) joining the first fluid channel forming an intersection junction 15. The first and second fluid channels 8, 10 can be completely enclosed by housing 4 or one or both can extend outwardly from the housing (for example, if the fluid 8, 10 comprise flexible connection tube adapters for coupling to an additional tube). The first and second fluid channels 8, 10 are sometimes collectively referred to here as a fluid joining element. In some variations, the fluid junction element may comprise a unitary element (for example, injection molded material, etc.). With other variations, the fluid junction element may comprise a plurality of sections (i.e., it is not unitary) and / or is integrated with the housing (for example, sections of the housing form the fluid paths).
[000100] The first fluid channel 8 can extend from the first end 12 to the second end 14. The second fluid channel 10 can extend from a medication port opening 13 at a distal end and can terminate in the first fluid channel 8 at the intersection 15 intermediate to the first end 12 and the second end 14. The medication port 13 can be configured to fluidly couple a fluid outlet 17 of the medication container 20.
[000101] An identification sensor 18 can be at least partially disposed within housing 4 (i.e., identification sensor 18 can be enclosed by housing 4 or a portion thereof can extend outwardly from an external surface of the housing 4, etc.) to generate information indicative of the contents and / or volume of contents of the medication container 20. In some variations, the identification sensor 18 can generate said information when the fluid outlet 17 from the medication container 20 is fluidly coupled to the medication port 13. In other variations, the identification sensor can generate this information when the fluid outlet 17 from the medication container is adjacent to the medication port 13. A transmitter 34 can be arranged inside the housing 4 and in communication with / coupled to an identification sensor 18 to wirelessly transmit the information 36 generated by the identification sensor 18 to the remote data collection system 6. Exe Wireless hardware samples and protocols can be used such as Bluetooth, Zigbee, Continue, Wireless USB, Wibree, relevant IEEE 802 standards (for example, 802.11, 802.15, or 802.16, etc.) and other methods. Data transmissions may, in some implementations, be encrypted to ensure patient privacy and / or to comply with the various laws regarding the handling of medical data. The transmitter 34 can have said encryption capability or one or more additional integrated circuit groups can be incorporated within the drug injection field 3 to provide said encryption. The signal from the identification sensor 18 can be processed and prepared for transmission by sensor circuit 30. The self-contained power source 19 (e.g. battery or battery structure, etc.) can be arranged within the housing 4 to provide energy for one or more of identification sensor 18, sensor circuit 30 and transmitter 34.
[000102] The housing 4 and / or the entire field of medicine injection 3 can have a shape and size allowing it to be portable by a user's first hand while the user administers medication from the medication container 20 by means of of a fluid outlet 17 using your second hand. Housing 4 and / or the entire field of drug injection 3, excluding any external tube, may, in some implementations, be larger than 10 centimeters or less. In addition, the entire housing 4 and its components contained and / or the entire field of drug injection 3 can be light in being less than 1 kg, and in some implementations, less than 100 grams and in some implementations less than 50 grams . The lightweight and / or compact nature of the medicine injection field 3 allows it to be suspended below the fluid source in a Y-field (or to replace a Y-field) and supported by tube assembly 11 during use (see diagram of FIGURE 10B). Alternatively, the small size and weight can facilitate use in the tube assembly 11 closest to a patient's injection field and can be conveniently attached to the patient's arm (see diagram in FIGURE 2C).
[000103] In some implementations, housing 4 can be separated into two sub-housing (see diagram of FIGURES 15 A, 15B, 15C, 15D). A reusable sub-housing 80 can house reusable elements (ie elements that can be safely used between different patients, etc.) while a disposable sub-housing 82 can house disposable elements (ie, low-cost and / or sterile elements that are recommended for use in connection with a single patient, etc.). The sub-housings can be operationally coupled by connecting element 84 thus forming a fully functional injection field 3.
[000104] Housing 4 can be produced from a rigid material that protects the component contained within housing 4 from manipulation and fluids during use. The housing 4 can rigidly position and fix its contained components with respect to each other. The housing 4 can be produced by plastic injection molding of a material such as polystyrene or polycarbonate to form one or more parts of the housing. Sections of housing 4, in some implementations, may form the first fluid channel 8 and the second fluid channel 10. In one variation, all housing 4, including medication port 13, the first and second channels 8, 10 and components internals can be provided with sterile protective covers at the first end 12 and the second end 14 of first fluid channel 8 as well as at the medication port 13.
[000105] All or some of the components of the drug injection field 3 can be selected so as to withstand conventional sterilization processes for single-use medical devices such as EtO or radiation. The medicine injection field 3 can be packaged with sterile covers in place in a stripping pocket kit configuration and provided to the user with a ready-to-use sterile fluid delivery path with medications and / or sterile fluids. Instruction for use and / or other identification materials can be included with the medicine injection field 3 to form a kit.
[000106] Removing one or more of the sterile covers in the medicine injection field 3 can result in a self-contained power source 19 triggering one or more of transmitter 34 and sensor circuit 30. Initial drive sequences can synchronize communications between transmitter 34 and receiver 42 (see FIGURE 5). Indicator 35 (see FIGURE 5) can indicate readiness to send medication and the data collection system 6 can indicate the start of the medication record maintenance. In some implementations LED emitter 32 can provide readiness information to the user similar to the function of indicator 35. LED emitter 31 can illuminate housing 4 and / or the medicine injection field 3 with a visual alert (for example, flashing light , etc.) thus drawing the user's attention to the injection port and its readiness for operation. Thereafter, when the medication container 20 is coupled to the medication injection field 3 the emitter LED 31 (or indicator 35) can illuminate the medication field 3 and the fluid outlet of the medication container 20 in a steady ON state indicating the successful fluid coupling and detection of the identification member. Other visual indicators such as combinations of flashing and / or stable ON can indicate various operating states of the injection port.
[000107] FIGURES 2C and 2D are diagrams that illustrate the medication injection field 3 with the medication container 20 in a coupled state. In said variations, the drug injection field 3 does not include a first fluid channel 8 as part of the injection field 3. Only the second fluid channel 10 is included. The second fluid channel 10 can be completely enclosed by the housing 4 or it can extend outwardly from the housing. In addition, other elements can be included in housing 4 which will be described later. Said may include safety valve 23, indicator 35, memory element 38 and / or watch 39. The medicine injection field 3 can be for single use and completely disposable. In a different variation, the drug injection field 3 can be separable into a disposable portion and a reusable portion as will be discussed in FIGURES 15A-15D.
[000108] FIGURE 2C illustrates housing 4 directly coupled to an "Y" field of an IV infusion tube assembly 11. The second fluid channel 10 can extend from a medication port opening 13 at one end distal and may terminate at a fluid outlet end 14. The second channel 10 may include a length of fluid delivery tube to permit positioning of housing 4 for the convenience of the user. The medication port 13 can be configured to fluidly couple with a fluid outlet 17 of the medication container 20 (see FIGURE 2A). The fluid channel 10 can include a safety valve 23 to limit fluid backflow from the infusion field tube assembly "Y" 11 within the fluid channel 10. Alternatively, the safety valve 23 can be included in the port of medication 13 and adopt the form of a clean, needle-free injection connector facilitating a Luer connection from the field of medication injection 3.
[000109] An identification sensor 18 can be arranged inside the housing 4 to generate information indicative of the contents and / or volume of contents of the medication container 20. In some variations, the identification sensor 18 can generate said information when the outlet fluid 17 of the medication container 20 is fluidly coupled to the medication port 13. In other variations, the identification sensor can generate said information when fluid outlet 17 from the medication container is adjacent to the medication port 13. One transmitter 34 can be arranged inside the housing 4 and in communication with / coupled to an identification sensor 18 to wirelessly transmit the information 36 generated by the identification sensor 18 to the remote data collection system 6. The signal from the sensor identification 18 can be processed and prepared for transmission by the sensor circuit 30. A fluid delivery sensor 60 can be included in housing 4 to provide information indication of fluid flow and / or a volume characteristic. The signal from the fluid sending sensor 60 can be processed and prepared for transmission by the sensor circuit 30. Information 36 indicating fluid flow and / or volume can be transmitted by transmitter 34 to the data collection system 6. A self-contained power source 19 (e.g., battery or battery structure, etc.) can be arranged within housing 4 to provide power for one or more of identification sensor 18, fluid send sensor 60, sensor circuit 30, transmitter 34 and indicator 35.
[000110] The housing 4 and / or the entire field of medicine injection 3 can have a shape and size allowing it to be portable by a user's first hand while the user administers medication from the medication container 20 through the fluid outlet 17 using your second hand. Housing 4 and / or the entire field of drug injection 3, may in some implementations have a dimension greater than 10 centimeters or less. In addition, every housing 4 and its components contained and / or every field of drug injection 3 can be light in being less than 100 grams, and in some implementations, less than 50 grams. The light and / or compact nature of the medicine injection field 3 allows it to be suspended below the fluid source attached to an upper Y-field and supported by the tube assembly 11 during use. Alternatively, the small size and weight can facilitate use in the tube assembly 11 attached to a lower "Y" field closest to a patient's injection field and can be conveniently attached to the patient's arm.
[000111] FIGURE 2D illustrates housing 4 directly coupled to a needle for direct injection to a patient. The second fluid channel 10 may extend from a medication port opening 13 at a distal end and may terminate at the fluid outlet end 14. The second channel 10 may include a length of fluid delivery tube to allow positioning of housing 4 for user convenience. The medication port 13 can be configured to fluidly couple with a fluid outlet 17 of the medication container 20. In addition, other elements can be included in housing 4 which will be described later. Said may include safety valve 23, indicator 35, memory element 38 and / or clock 39.
[000112] An identification sensor 18 can be arranged inside the housing 4 to generate information indicative of the contents and / or volume of contents of medication container 20. In some variations, the identification sensor 18 can generate said information when the outlet fluid 17 of the medication container 20 is fluidly coupled to the medication port 13. In other variations, the identification sensor can generate said information when the fluid outlet 17 from the medication container is adjacent to the medication port 13. A transmitter 34 can be arranged inside the housing 4 and in communication with / coupled to an identification sensor 18 to wirelessly transmit the information 36 generated by the identification sensor 18 to the remote data collection system 6. The signal from the sensor identification tag 18 can be processed and prepared for transmission by the sensor circuit 30. A fluid delivery sensor 60 can be included in housing 4 to provide information information indicating fluid flow and / or the volume characteristic or a sensor of the type of medication composition. The signal from the fluid sending sensor 60 can be processed and prepared for transmission by the sensor circuit 30. Information 36 indicating fluid flow and / or volume and / or type of medication can be transmitted by transmitter 34 to the delivery system. data collection 6. The self-contained power source 19 (e.g. battery or battery structure, etc.) can be arranged within housing 4 to provide power for one or more of identification sensor 18, fluid delivery sensor 60 , sensor circuit 30, transmitter 34 and indicator 35.
[000113] The fluid delivery sensor 60 shown in FIGURE 2D can be a medication composition sensor to provide verification of the type of injected fluid (a medication composition sensor can be one or more sensors that are separated and distinguished from fluid delivery sensor 60). The medication composition sensor 60 can be any one or more of a pH detector, a viscosity indicator, an optical density indicator, a chemical indicator, a drug molecule indicator, a drug sensor, a spectrophotometer, a HPLC detector, UV detector, fluid density sensor, specific gravity sensor, etc. Alternatively, or in combination with the above, a composition sensor 60 can be a combination of a series of measured parameters, including but not limited to the above parameters, which are shown in the table with indicative medication values. The table can be included in the medicine injection field 3 or in the data collection system 6. The table can be compared to a stored observation table with a known set of parameter values for a specific type of medication and concentration to determine the type of medication and / or current concentration of the injected fluid.
[000114] The housing 4 and / or the entire field of drug injection 3 can have a shape and size allowing it to be portable by a user's first hand while the user administers medication from the medication container 20 directly to the patient through the needle. In another embodiment, the housing can be of a size and shape allowing it to be used by one hand. Alternatively, the needle shown in FIGURE 2D can be inserted into a "Y" field of the infusion set 11 as shown in FIGURE 2C.
[000115] FIGURES 3A-C illustrate various characteristics of the drug injection field 3. With reference to FIGURE 3A, the first end 12 of the first fluid channel 8 can be attached to a fluid source via the tube assembly 11 and the second end of the first fluid channel 8 can be attached to a patient via tube assembly 16. Although the tube assembly 11 and 16 are illustrated as being separate, some variations include a single tube assembly extending through the housing 4. The first fluid channel 8 can join the first end 12 (i.e., fluid inlet) and second end 14 (ie, fluid outlet) forming a fluid path within the housing 4. The first fluid channel 8 can be joined by the second fluid channel 10 at the intersection 15 for administering medication from the container 20. The intersection 15 can be positioned so that the relationship between the first fluid channel 8 and the second fluid channel liquid 10 is a right angle as shown in FIGURE 3A substantially forming a "T" shape. Alternatively, channels 8, 10 can be positioned to form an acute angle. In some implementations, the angle is such that the first fluid channel 8 and the second fluid channel 10 form a "Y" shape.
[000116] Safety valve 22 can be located in the first fluid channel 8 upstream of intersection 15 to prevent backflow of fluid upstream into the fluid source when the medication container 20 is sending fluid into the medication port 13. The second fluid channel 10 may contain the safety valve 23 to prevent fluid flow from the first fluid channel 8 to flow into the second fluid channel 10.
[000117] The medication container 20 can be a syringe or other medication container such as a vial with compatible fluid coupling outlet 17 in a medication container 20 for the medication port 13 (e.g., a slide Luer, a Luer locking fitting, a bottle adapter spout, etc.). The medication container 20 can include the information source 24 located on the fluid outlet fixing tip of the container 20. Said information source 24 can, in some implementations, be fixed, integrated, fixed, and / or adhered to a intermediate portion to the medication container fluid outlet 20 and the container cylinder portion 20. Said intermediate portion can be tapered and / or flat. The information source 24 can be an integrated feature of the medication container 20 such as engraved or molded features. The source of information 24 can alternatively be adhered to the fluid outlet fixing tip of the medication container 20 (i.e., the source of information 24 can be a label, etc.). In addition, the information source 24 can be a separate element that extends around the fluid outlet of the medication container 20 (applied either during the manufacture of the medication container or subsequently during distribution or use).
[000118] When provided to a user, medication port 13 can be protected by a port cover 21. Before use, port cover 21 keeps medication port 13 in a sterile condition. Similarly, when provided as an extension set (i.e., the drug injection field 3 includes an added tube that increases the functional capacity of the fluid delivery line and extends the fluid tube set 11), sterile covers can be provided at the first end 12 and the second end 14 of the first channel 8. When used, the medicine injection field 3 can be connected to the fluid source by removing the sterility cover at the first end 12 and fixing the tube assembly 11. Second, the sterility cover can be removed from the second end 14, the fluid flow is then established through the first fluid channel 8 and then the second end 14 is connected to the tube 16. The tube 16 can then be attached to a patient's catheter to send fluids and medications.
[000119] The identification sensor 18 can include a pair of optical emitter / detector 31 with horizontal orientation in the sensor 18 that detects coded information contained in the information source 24 (a sleeve around the fluid outlet of the medication container 20) parallel at the outlet of the fluid shaft. The identification sensor 18 can comprise the plurality of sensors to detect the information source 24. In some variations, the medication sensors can be sensors such as optical, magnetic, mechanical, conductive, switchable RFID and / or proximity sensors. In other variations, the identification sensor 18 may be optical and may include a light source (emitter) such as an LED and a detection source (detector) such as a camera (CCD). Sensor circuit 30 can provide signal processing and connects identification sensor 18 to transmitter 34. Identification sensor 18 can be directly coupled to a power source 19.
[000120] FIGURE 3B illustrates a side view of the medicine injection field 3. Housing 4 is dimensioned and formed to fit easily within a user's hand. The medication port location 13 can be anywhere along the length of the first channel 8 and conveniently positioned for ease of use.
[000121] FIGURE 3C is an enlarged view of the medication port 13 showing the identification sensor 18 provided with a concentric (or at least partially concentric) configuration so that it can surround the information source 24 at the outlet 17 of the container of medication 20. When the medication container 20 is coupled to the medication injection field 3, the outlet 17 is fluidly coupled to the medication port 13 and the information source 24 is simultaneously positioned for detection inside and in proximity to the identification sensor 18.
[000122] FIGURES 4A, 4B, 4C and 4D illustrate an alternative implementation of information source 24 and identification sensor 18. FIGURE 4A illustrates a cross-sectional view of the medication container 20 coupled to a medication injection field 3 FIGURE 4B is a side view. The drug injection field 3 can include a pair of optical emitter and detector 31 positioned and configured to optically detect the encoded information 29 in the information source 24. The information source 24 can take the form of a disk or other element with a opening mounted on the fluid outlet perpendicular to the fluid shaft outlet. The information source 24, when adopting the shape of a disk, can be substantially flat and includes an internal opening 27 (see, for example, FIGURES 4A, 4C, 4D) corresponding to the fluid outlet 17 of the medication container 20 Said information source 24 can be mounted to the medication container 20 so that internal orifice 27 is concentric with the fluid outlet 17 (and positioned so that the medication container 20 can still be coupled to the medication injection field. 3 and medication can be sent).
[000123] As shown in FIGURES 4C and 4D when used, the information source 24 and the medication container 20 can be rotated together clockwise to complete the fluid coupling of the fluid outlet 17 to the medication port 13. Indications of barcode 29 are also rotated correspondingly. The pair of optical emitter / detector 31 can read (i.e., illuminate and detect) the rotated bar code signal 29 and extract the identification information. Said identification information can then be passed from the sensor circuit 30 to the transmitter 34 for transmission.
[000124] In some implementations, the identification sensor 18 can include a series of more than one sensor to detect the information source 24. In addition, medication sensors can be other types of sensors such as optical, magnetic, mechanical , switchable conductors, RFID and / or proximity sensors. With non-optical arrangements, the corresponding information source 24 and detector 31 would be modified accordingly. For example, if the information source 24 comprises a magnetic strip, the detector may be a magnetic strip reader. In addition, the sensor circuit 30 provides signal processing and connects identification sensor 18 to the transmitter 34.
[000125] FIGURE 5 illustrates additional elements of system 2 including a drug injection field 3 with a second centrally located fluid channel 10, additional elements contained within the data collection system 6 and connection to a medical information system 52 The medicine injection field 3 can include information processing and transmission circuit 32. Signals from sensor circuit 30 can be processed for transmission to data collection system 6 by circuit 32. Sensor circuit 30 can generate a or more signals in response to the connection of the medication container 20 to the medication port 13. When the identification sensor 18 detects the connection of the medication container 20 a visual and / or audible indicator 35 can be triggered to provide feedback to the user of the medication correct connection. Transmitter 34 can transmit information 36 to receiver 42 contained in a data collection system 6. When transmitter 34 transmits information 36 to receiver 42 a visual and / or audible indicator 35 can be triggered to provide feedback to the user of the correct transmission.
[000126] The sensor circuit 30 may contain a Hall effect sensor 33 that detects the completion of medication administration when magnetic indicator 26 is in close proximity to sensor 33. Alternatively, sensor 33 and indicator 26 can be optical, mechanical, conductors and / or sensor / proximity sensor pairs and provide a complete medication delivery signal to circuit 32. In this case, a second transmission of information 36 can be sent to receiver 42 in response to a signal from sensor 33. When transmitter 34 transmits information 36 to receiver 42 a visual and / or audible indicator 35 can be triggered to provide feedback to the user of the correct transmission of the completion of medication administration.
[000127] The medication sent from the medication container 20 can flow through the outlet 17 into the second fluid channel 10, ahead of the safety valve 23 and into the first fluid channel 8. The fluid from the fluid source enters the first fluid channel 8 at the first end 12, flows ahead of the safety valve 22 and out to the patient through the second end 14 and the tube 16.
[000128] Data collection system 6 receives information 36 (for example, packaged data, etc.) from transmitter 34 within the medicine injection field 3. In a variation, data collection system 6 can include a personal computer (see FIGURE 14A). In another variation, the data collection system 6 can be small, light weight and configured to be independent with the self-contained power source 43 (see FIGURE 14B). The data collection system 6 can be portable so that, for example, it can provide medication administration information to emergency medical services staff in the field or it can be used in mobile carts, automated dispensing units medication, or other medication storage systems by healthcare professionals within a hospital, other healthcare facility or within a home care setting. In an implementation, after medications are sent (or during shipment) and the health care protocol is complete data collection system 6 can be connected (for example, via a web service, wireless, or connection direct, etc.) to the medical information system 52 for transferring records and / or storing data and / or patient billing, etc.
[000129] The data collection system 6 and / or the medicine injection field 3 can initiate wireless information exchange. Discovery message / agreement exchanges are used to initiate communications (either when drug injection field 3 is first used or when communications are interrupted, etc.). The medicine injection field 3 can interface with multiple data collection systems 6 at a time or simply pass information from a first data collection system 6 to subsequent data collection systems 6 (using, for example, memory resident in the field of medicine injection 3 as described below).
[000130] Within the data collection system 6, the information received by the receiver 42 is sent to and processed by circuit 44. Circuit 44 contains a message decoder and screen trigger circuit 46, a microcomputer 47, an information system of screen and record 48 and clock 49. The information received is marked with time by clock 49, logged into memory and displayed by circuit 48. The information displayed and recorded can include one or more of: the type and quantity of medication sent , medication administration time, sequence of medications sent, suggestion messages providing real-time feedback to the healthcare provider on previous medications sent, suggestion messages for future medications to be administered with the proposed protocol administration times, time in which the medication was administered and other instructional information to conduct the health care protocol.
[000131] The screen and recording system 48 can receive messages and generate a record documenting the timing of medication injections based on the signals received from the sensor circuit 30. The screen and recording system 48 can, in some variations, include a report generator capable of sending report information 50 to a medical information system 52. A user 54 can interact with a microcontroller 47 via user interface 56 to provide additional information to the display and recording system 48. In addition, user 54 can edit the report, add non-medication administration information to the report and complete the printing or filling out of the report with a medical information system 52. Medical information system 52 can be coupled to a network and / or accessible via the Internet.
[000132] The screen and recording system 48 can take the received information 36 and combine it with the time information from the clock 49 to generate a time-stamped information record. The computer system 47 can receive the timing information for each medication injection. The medication information included in the time log file may include, but is not limited to, type of medication, volume of medication injected, medication expiration date, medication manufacturer information and user-edited report information. This information can be integrated with medical files for the patient and / or submitted to a patient billing system (for example, through a web service, etc.).
[000133] The message decoder and screen trigger circuit 46 can convert each signal into a coded value indicative of medication administration. The encoded value can then be provided to computer system 47 which decodes the value and provides the user with understandable information about the injections for editing.
[000134] In some implementations, the drug injection field 3 may contain memory 38 to store the medication administration data. The data may include a sequential record of each medication administration produced through the drug injection field 3. Timer 39 provides time counting data for memory 38 separating each of the successive medication administration data elements. Situations that may occur requiring the use of memory 38 and timer 39 include: failure of the data collection system 6, inadvertent failure of the user to activate the data collection system 6, transfer of a patient from a collection system of data 6 to another while transferring the patient to different health care professionals (field emergency medical care provider to ambulance care provider to hospital emergency room care provider, etc.). In these situations, the patient's medication administration data is stored in memory 38 and can be retrieved later by a different data collection system 6. Memory 38, in some implementations, can be removable allowing it to be accessed by a computing system. For example, memory 38 can be part of a USB card allowing it to be removed and accessed by a separate computer system. In some variations, memory 38 can store software either to run a local application on said separate computing system or to run a particular website or start a web service. In any of said scenarios, patient data can be transported for storage and / or display in said separate computing system (or to another remote computing system from said separate computing system).
[000135] Various types of medication containers 20 can be used with the medication injection field 3, provided that the fluid outlet 17 of the medication container can couple to the medication port 13. FIGURES 6A-8C illustrate the different arrangements such as syringes and reverse syringes. Other containers (not shown) can be in the form as discussed earlier.
[000136] FIGURES 6A and 6B illustrate a drug injection field 3 with some elements removed for the purpose of illustration. FIGURE 6A illustrates top and front views of housing 4 to the left with the medication container 20A over to be coupled to the medication port 13. A side view is illustrated on the bottom right with the medication container 20A fully engaged with the port of medication 13. The end of the first fluid inlet 12 and end of the second fluid outlet 14 can be connected via the first fluid channel 8. The fluid inlet 12 and the fluid outlet 14 can be a slide Luer, a Luer locking or other fluid-fit adapters and are typically equipped with sterile protective covers before use. The second fluid channel 10 can join the first fluid channel 8 at the intersection 15. The medication port 13 is initially provided for use with a sterile barrier cap 21 which is removed immediately before the medication injection. Alternatively, medication port 13 can be a clean, needle-free injection connector facilitating Luer connection from the syringe or other medication container 20. In some variations, medication container 20 may include a needle or port adapter outlet that acts as outlet 17 which in turn is fluidly coupled to the medication port 13.
[000137] Housing 4 may at least partially contain identification sensor 18, sensor circuit 30, transmitter 34 and a common power source 19 (battery, battery structure, etc.). The sensor circuit 30 can provide for one or more medication sensors 18 (and / or 218 in FIGURE 17) to detect information from the medication information source 24 (and / or supplementary information source 224 in FIGURE 17). The transmitter 34 can process the signals from the sensor and transmit them to a data collection system 6.
[000138] In FIGURE 6A the medication container 20A can be a syringe with a fixed medication container and a sliding plunger 25 that moves during the administration of the medication. The medication container (A) 20A can have the medication information source 24 attached to the tip. There may be a number of variations (a, b, c, d) for information source 24. Information source 24a may contain information (for example, readable data, etc.) indicative of the medication in one or more horizontal bands. The information source 24b contains information indicative of the medication in one or more vertical bands. The information source 24c contains information indicative of the medication in a combination of one or more horizontal and vertical bands. The 24d information source may contain information indicative of the medication at one or more points in a two-dimensional dot matrix pattern.
[000139] Additionally, the plunger 25 may contain a ferric material 26A that can be detected by the magnetic sensor 33. The ferric material 26A may be a magnet or other type of iron material associated with a ferric material type sensor 33. When shipping medication is a complete plunger 25 with ferric material 26A comes in close proximity with sensor 33 and a complete medication administration signal is sent to circuit 32. Transmitter 34 then sends the information to receiver 42 for data collection. Other materials / devices can be used to detect the relative position of the plunger 25.
[000140] With reference to the upper right portion of FIGURE 6A, the source of information 24 can be an RFID tag with an antenna that can be connected or disconnected by a key. With said arrangement, a switchable RFID label information source 24 can be provided with the antenna disconnected. When the medication container 20 is connected to the medication port 13 the antenna becomes connected (activated) and the information source 24 can be read by an RFID reader identification sensor 18 inside the housing 4.
[000141] FIGURE 6B is an enlarged view showing the fully engaged information source 24 in immediate proximity to the identification sensor elements 18 emitter (E) and detector (D) shown on the left or elements 31 LED emitter (E) and camera detection (CCD) of the identification sensor 18 shown at right and Hall effect sensor 33 all contained within housing 4.
[000142] FIGURES 7A and 7B illustrate the medication container 20B and injector housing 21B being a reverse syringe configuration in which the plunger 25 remains fixed with respect to the movement of the medication container 20B during medication administration. FIGURE 7A on the left shows the medication container 20B with the medication information source 24 attached to the Luer fitting tip prior to connection to the medication port 13. Similar to the medication container 20A, there may be a number of mechanical modes (a , b, c) for the information source 24 in the medication container 20B. In addition, the medication container 20B may contain an indicator 26B which may be ferric material that can be detected by the magnetic sensor 33. The ferric material 26B may be a magnet or other type of iron material associated with the ferric type sensor. 33. Other types of indicators such as optical, capacitive, mechanical, etc. that are not iron-based can be used to indicate completion of medication administration. When medication delivery is completed as shown on the right of medication container 20B with ferric material 26B that enters immediate proximity for detection by sensor 33, a complete medication delivery signal (or other data) can be sent to circuit 32. The transmitter 34 then sends the information to the receiver 42 for data collection.
[000143] Indicator 26B may, in some implementations, be a switchable RFID tag with an antenna that can be connected or disconnected (see FIGURE 6A). In said variation, an RFID indicator tag 26B can be provided with the antenna disconnected. When the medication container 20B is completely moved the antenna can become connected (activated) and a sent medication indicator 26B can be read by an RFID reader inside the sensor circuit 30.
[000144] FIGURES 7A and 7B illustrate a variation in which the information source 24 comprises a collar 24c with mechanical indicator pins. FIGURE 7A illustrates a top and front view of housing 4. As shown on the left, the medication container 20B is to be coupled to the medication port 13. A side view is illustrated on the bottom right so that the medication container 20B it is completely engaged with medication port 13. The collar 24c can have one or more indicator pins arranged as to indicate the type of medication contained in the medication container 20B. Any number of pins and / or pin patterns (a, b, c) can be used as an indication of the type of medication contained. The housing 4 may include a receiver identification sensor 18r which is provided with opening holes for receiving the pins in the collar 24c. Any number of opening patterns (a, b, c) can be used as an indication of the type of medication contained, the volume of medication, and / or the expiration date. When properly engaged, the pins on the collar 24c correspond to the openings of the receiver identification sensor 18r and form the transfer of medication information. The indicated pattern is detected by the identification sensor 18 and a signal can be sent to circuit 32. The transmitter 34 can then send the information to the receiver 42 for data collection.
[000145] The information source 24c may alternatively have external indicator ribs (or similar type of protuberances). The information source 24c may have one or more indicator ribs arranged as to indicate the type of medication contained in the medication container 20B or other relevant information. Any number of ribs and / or rib patterns (a, b, c) can be used as an indication of the type of medication contained. The housing 4 may include a receiver identification sensor 18r which is provided with opening slots for receiving the ribs in the information source 24c. Any number of opening patterns (a, b, c) can be used as an indication of the type of medication contained. When properly engaged, the ribs in the information source 24c may correspond with the grooves of the receiver identification sensor 18r or other characteristics. The pattern indicated by the information source of the receiver 18r can be detected by the identification sensor 18 so that a signal containing data that characterizes the medication container 20 is sent to circuit 32. The transmitter 34 then sends the information to the receiver 42 for collection of data.
[000146] FIGURE 7B is a diagram illustrating an enlarged view showing a fully engaged information source 24 in immediate proximity to the emitter (E) and detector (D) elements 31 of the sensor circuit 30 and the sensor 33 all contained within the housing 4. The information source 24c may have protrusions (in this case four pins) protruding from collar 24c. The receiver identification sensor 24r can correspond with the pins in the information source 24c facilitating the detection of medication information by the emitter (E) and detector (D) sensors mounted on the sensor circuit 30. Additionally, the sensor 33 is shown located on the uppermost part of housing 4 for the detection of ferric material 26B.
[000147] FIGURES 8A, 8B and 8C illustrate a variation of the information source 24. FIGURE 8A illustrates the information source 24 formed as a flat disk mounted at the fluid outlet 17 of the medication container 20. The information sensor 18 it can be oriented vertically and detects information when the medication container 20 is rotated over the fluid shaft outlet. The information can be encoded using optical or magnetic methods. In one implementation, the information source 24 can carry a radial barcode pattern 29. Emitter / detector pairs 31 can detect information and signals can be provided to the sensor circuit 30 that characterize the medication container 20. A source alternative information (a two-dimensional bar code) and emitter / detector pair 31 (LED and CCD camera) are shown in FIGURE 4D.
[000148] FIGURE 8B illustrates the information source 24 as a cylindrical / circumferential strip provided with an external surface that is mounted to the fluid outlet 17 of the medication container 20. The information sensor 18 can be oriented horizontally and detects the information when the medication container 20 is rotated on a fluid shaft outlet. The information can be encoded using optical or magnetic methods. The strip may have a barcode pattern that extends along the cylindrical surface at a constant radius. The emitter / detector pairs 31 can detect the information and signals characterizing the medication container 20 can be provided to the sensor circuit 30.
[000149] FIGURE 8C illustrates an enlarged view of the elements shown in FIGURE 8A. A fixing material 37 can be disposed between the medication container 20. The fixing material 37 can be configured to be releasable from a first medication container and affixed to a second medication container. The fastening material can be an adhesive material or a mechanical material to snap into place. Alternatively, the information source 24 (disc or bowl) may include gripping or locking teeth on the inner diameter 27 of the information source 24. This feature can be used when an original medication container 20 (medication bottle) is provided without a fluid outlet and a second medication container 20 (syringe) is used to withdraw the medication from the first medication container 20 (vial) for use with the medicine injection field 3. The source of information 24 originally provided with the first medication container (vial) can be removed and then attached to the second medication container (syringe) during a medication transfer process. The contents of the second medication container 20 can be injected into the medication port 13 and the information can be detected by the information sensor 18.
[000150] The medication container can be a first medication container and the identification member can be releasably attached to the medication container to allow it to be removed for disposal in a second medication container. The identification member can carry a fixing element allowing it to be removed from the first medication container and attached to the second medication container. The transfer of the identification member from the first medication container to the second medication container can be completed during the process of transferring the medication from the first medication container to the second medication container.
[000151] FIGURE 8D illustrates an alternative information source 24 in the form of a cup similar to information source 24 in FIGURE 8B except that the information source cup 24 fits around the Luer tip of the medication container outlet and can be detected by the horizontally mounted information sensor 18 as shown in FIGURE 8C. The information source cup 24 can be fixed and detached in a similar way to the information source disc 24 to the fixing material 37.
[000152] FIGURES 9A, 9B and 9C illustrate top and front views of alternative construction modalities of the fluid junction element and housing 4. FIGURE 9A shows the housing 4 with a first direct fluid channel 8 with a lateral access for the medication port 13. FIGURE 9B shows the housing 4 with a first fluid channel at right angles 8 with a lateral access to the medication port 13. FIGURE 9C shows accommodation 4 with a first fluid channel "Y" 8 and a direct medication port 13. Various other configurations can be constructed with different inlet 12, outlet 14 and medication port 13 placements to facilitate any clinical installation needs, hospital equipment orientation, and / or medical professional preference . FIGURE 9A illustrates a configuration that is a typical extension set facilitating in-line attachment from tube assembly 11 to a patient catheter. FIGURE 9B illustrates a configuration that facilitates connection to a pipe (outlet 14) and allows direct injections into the medication injection port 13. FIGURE 9C illustrates a configuration that is a typical "Y" field arrangement facilitating the location of the medication port 3 on tube assembly 11.
[000153] FIGURES 10A and 10B illustrate alternative variations for housing 4 as mounted on the fluid delivery tube assembly. FIGURE 10A illustrates an adapter field configuration "Y". Here the inlet 12 and the outlet 14 can be separated by an extended conduit 8 to form an extension set. FIGURE 10B illustrates a complete set of fluid delivery tube with inlet 12 being a fluid bag pin and outlet 14 a connector to a patient access device. Housing 4 can be located next to the fluid source bag in a higher "Y" field or closer to the patient in a lower "Y" field location. Multiple configurations (for example, two or more medication injection fields used for a single patient, etc.) allow greater access to the medication injection tube set during medical procedures when multiple healthcare professionals are simultaneously working on a patient (and access to a particular medicine injection field can be prevented). Other configurations can be used as a function of the physical space of the clinical facility and access to the tube set.
[000154] FIGURES 11A and 11B illustrate a medicine injection field 3 incorporating fluid flow sensor 60. Fluid flow sensor 60 can be a pressure measurement sensor with differential pressure inputs 62 and 64 which are fluidly connected to the first fluid channel 8. Pressure transducer 66 can provide a differential pressure signal 70. When the medication container 20 sends fluid to the second fluid channel 10 there is a sudden increase in the differential pressure signal 70 due to the flow of fluid through orifice 68. The said change in differential pressure indicates that fluid is being sent from the medication port 13. The value of the differential pressure signal 70 can be provided to transmitter 34 and subsequently transmitted to receiver 42 as shown in FIGURE 5. Pressure signal 70 can be sent to message decoder & screen trigger 46. Microcomputer 47 can contain algorithms to calculate the volume of fluid sent based on the differential pressure. When the volume sent is equal to the original volume in container 20, the end of medication delivery is recorded. The knowledge of the differential pressure, the time, the orifice cross-sectional area 68 and the cross-sectional area of the first fluid channel 8 allows the calculation of the volume of fluid sent.
[000155] A variation of the medicine 3 injection field system of FIGURE 5 is shown in FIGURE 11B and illustrates a construction with pressure transducer 66 positioned in the second fluid channel 10 instead of the first fluid channel 8. The fluid inlets 62 and 64 can be located downstream or upstream of safety valve 23. In said configuration, orifice 68 is located in the second fluid channel 10 between inlets 62 and 64. The volume sent is calculated in the same way that above using the microcomputer algorithms 47.
[000156] In other constructions, the fluid flow sensor 60 may include a single channel pressure transducer 66. In said variation, the volume can be calculated as the integral of the pressure increase over time.
[000157] FIGURE 12 illustrates a detailed view of the pressure measurement components 62, 64 and 66 and orifice 68. The calculation of the volume can be based on the Bernoulli Equation and Volume = coefficient x time. The discharge coefficient R is calculated using the formula shown in FIGURE 12 on the right where Cs is an empirically derived constant to calibrate the system, A2 / A1 is the proportion of the orifice areas 68 (A2), first fluid channel 8 (A1 ) and "g" is the density of the fluid. Differential pressure 66 can be the pressure difference between input 62 (p1) and input 64 (p2). It can be assumed that the density "g" of the fluid in the medication container 20 is that of the water. However, other fluids with other densities can be used and the calculations adjusted accordingly. The volume calculation can be completed within circuit 60 before wireless transmission or circuit 44 (not shown) after wireless transmission.
[000158] In some variations, the fluid send sensor 60 can be used to directly read the fluid flow. Said fluid delivery sensor 60 is based on one of a paddlewheel flow meter, a turbine flow meter, a thermal flow meter, an ultrasonic flow meter, a cryolysis type flow meter , etc.
[000159] FIGURES 13A and 13B illustrate differential pressure graphs - times at various points in the operation of the system shown in FIGURES 11A and 11B. FIGURE 13A illustrates a graph of pressure and normal time. Initially at time to, the pressure is at level 70 with no force applied to the medication container 20. At time t2 when the user increases the force F by pressing on the syringe plunger rod or the medication container 20 of the reverse syringe, the differential pressure increases from 70 to 72 at time t2 indicating user activity. Said higher pressure 72 is sustained over time from t2 to t6 when the pressure returns to level 70 at time t7 when medication administration is completed. The calculated volume confirms that the medication has been sent. If the pressure is only maintained from t2 to t3 then an incomplete volume has been sent. Several time points t3, t4, t5 and t6 are indicative of 25%, 50%, 75% or 100% of volume sent respectively. The volume calculation can be displayed to the user providing feedback on the volume sent and timestamp recorded as the partial dose of the medication.
[000160] FIGURE 13B illustrates a different pressure-time graph where the pressure is lower, indicating slower medication delivery. At time t1 the initial pressure 70 increases to the level 74 which is less than the pressure level 72 in FIGURE 13A. The pressure is maintained for a longer period of time through t3, t4, t5, and t6 where the pressure then decreases back to level 70 at time t7. Similarly as shown in FIGURE 13A, if the pressure is not sustained but instead drops prematurely at t3, t4 or t5 an incomplete volume is calculated. There may be a number of other combinations of times and differential pressures used in calculating the volume.
[000161] FIGURES 14A and 14B illustrate two variations of the data collection system 6. The screen and register system 48 can include any combination of hardware and software to receive signals from transmitter 34 and record the sequence of administrations medication. The receiver 42 can be just a receiver or a transceiver (i.e., a combined transmitter-receiver, etc.).
[000162] With reference to FIGURE 14A, the data collection system 6 may include a general purpose personal microcomputer 47 with a USB connection to the receiver 42. In another embodiment shown in FIGURE 14B, the data collection system 6 can be independent and driven by a self-contained power source 43. FIGURE 14A illustrates a general purpose USB device with receiver 42 mounted in the USB housing with USB connection to a standard microcomputer 47 and a message decoder 46. Information 36 received by receiver 42 is transferred via USB to an external microcomputer 47. The software in message decoder 46 and microcomputer 47 can process information 36, add a time stamp from clock 49 and display and record the information via the display information system and register 48. The screen, registration and function software is located on microcomputer 47. Microcomputer 47 can provide information 50 to the medical information system 52 as shown in FIGURE 5.
[000163] FIGURE 14B illustrates a more integrated, self-contained and dedicated data collection system 6. Receiver 42, message decoder 46, microcomputer 47, screen and record system 48, clock 49 and microcomputer 47 are combined within one module. The receiving circuit 42, the message decoder 46 and the screen and recording system 48 can be operated by microcomputer 47. The self-contained power source 43 provides power for mobile operation.
[000164] Information circuit 44 may include or otherwise use software to provide the functions of the data collection system. These functions can be consolidated within the separate data collection and record keeping device or distributed through a medical information system or a combination of both. When the data collection system 6 is not functional or powered or when a patient is transferred from a data collection system 6 to a second data collection memory 38 it provides a history of medication administration data as discussed above. In this case, the second data collection system 6 can receive the history of medication administration data and time counts between subsequent medication administrations. The software automatically associates medication administrations with real time from clock 49. Screen recording system 48 is configured to process data, time recording, recording and display the previously recorded information to the user.
[000165] Additionally, the software within the data collection system 6 can include information stored in support of a series of medication administrations based on acute care protocols or several individual medication administrations not related to an acute care protocol. Thus, the software can display messages stored on the basis of medication injections in support of acute care protocol providing health care professionals with guidance in the conduct of the protocol. The software within the data collection system 6 can include a set of rules to cause alerts and or alarms to occur (directly through the data collection system 6 or when transmitting data to the other system, etc.) to inform the care provider with information about the protocol. The protocol can be a non-acute care protocol in which the management of a patient's care is recorded and verified for the appropriate drug, dose, time of administration. Other health care protocols can be envisaged which require monitoring, verification and documentation of medication administration.
[000166] Care protocols, such as acute care protocols, can be updated periodically, annually, or when studies indicate a need for updating. The information circuit 44 can be configured to receive updated information 50 from a medical information system 52 which is indicative of the most recent acute care protocols or protocol updates. The software of the information circuit 44 is in turn configured to update itself according to the updated information. Updated information can enhance any operational aspect of the software.
[000167] Although the above discussion describes an arrangement in which "raw" data is transmitted from drug injection field 3 to data collection system 6 so that microcomputer 47 can process said raw data to identify traces such as patient identification (for example, serial number or other unique medicine injection field identifier 3), medication container contents, volume, expiration date, and / or pressure or volume information, and / or other complementary information, it will be noted that one or more of said traits can be determined by the drug injection field 3. For example, memory 38 may contain mapping data that associates raw data generated by identification sensor 18 within one or more of : a patient identification or drug injection field 3 (for example, serial number, etc.). The contents of the medication container 20, the volume of the medication container 20, or expiration date of the contents of the medication container 20. That information can then be transmitted by the transmitter 34 to the data collection system 6.
[000168] FIGURES 15A, 15 B and 15C illustrate the housing 4 as shown in FIGURE 3A separated within the reusable sub-housing 80 and disposable sub-housing 82. FIGURE 15D illustrates the housing 4 as shown in FIGURE 2C and 2D separated within the sub-housing reusable 80 and disposable sub-housing 82. Several constructions can be used which distribute the medication injection port 3 elements either for reusable sub-housing 80 or for disposable sub-housing 82. Four variations are described below, however, other implementations can be adopted based on considerations such as overall size, weight, costs per patient, etc. When used, reusable sub-housing 80 is connected to disposable sub-housing 82 via interface 84. When connected, the drug injection field 3 becomes functional by providing power from power source 19 ("Battery"). When the power source is contained in the reusable sub-housing 80 a charge element (not shown) can be configured to recharge the power source between uses. When the power source is self-contained inside the disposable housing 4, no recharging is necessary (see FIGURES 3A, 4A and 5).
[000169] FIGURE 15A illustrates a first implementation of the sub-housing in which the reusable sub-housing 80 may include one or more of: transmitter 34, battery, indicator 35 and connector 86. In said variation, the disposable sub-housing 82 may include one or more of : memory 38, timer 39, sensor circuit 30, emitter / detector 31, flow sensor 60, identification sensor 18, first fluid channel 8, second fluid channel 10, safety valve 22, safety valve 23 and connector 88 Interface 84 can be formed by matching connector 86 with connector 88 and can be one or more of an electrical contact, a mechanical contact, an optical coupling, an electrical contact coupling or a magnetic coupling.
[000170] FIGURE 15B illustrates a second sub-housing implementation in which reusable sub-housing 80 may include one or more of: transmitter 34, battery, indicator 35, memory 38, timer 39 and connector 86. Disposable sub-housing 82 may include one or more than: sensor circuit 30, emitter / detector 31, flow sensor 60, identification sensor 18, first fluid channel 8, second fluid channel 10, safety valve 22, safety valve 23 and connector 88. The interface 84 it can be formed by matching connector 86 with connector 88 and can be one or more of an electrical contact, a mechanical contact, an optical coupling, an electrical contact coupling or a magnetic coupling.
[000171] FIGURE 15C illustrates a third implementation of sub-housing in which reusable sub-housing 80 may include one or more of: transmitter 34, battery, indicator 35, memory 38, timer 39, sensor circuit 30, transmitter / detector 31, sensor flow 60 and identification sensor 18. Disposable sub-housing 82 may include one or more of: first fluid channel 8, second fluid channel 10, safety valve 22, and safety valve 23. Interface 84 can be formed by a or more than one hydraulic coupling, mechanical coupling, optical coupling, electrical contact coupling or magnetic coupling.
[000172] FIGURE 15D illustrates a fourth implementation of sub-housing configured for direct medication administration as shown in FIGURES 2C and 2D. The reusable sub-housing 80 is shown in the center and can include one or more of: transmitter 34, processor, battery 19, indicator 35, memory 38, timer 39, sensor circuit 30, transmitter / detector 31, flow sensor 60 and sensor identification 18. The disposable sub-housing 82 shown on the left and right may include one or more of: second fluid channel 10 and safety valve 23. The interface 84 between the reusable sub-housing 80 and the disposable sub-housing 82 can be formed by one or more than a hydraulic coupling, a mechanical coupling, an optical coupling, an electrical contact coupling or a magnetic coupling.
[000173] FIGURES 16A, 16B and 16C illustrate three additional variations of the data collection system 6. FIGURE 16A illustrates a variation of a data collection system in which data collection 6 is coupled with or forms part of a secondary medical device 100 such as an ECG monitor, an EEG monitor, a blood pressure monitor, a defibrillator, a pulse oximeter, an ETC02 monitor, medication delivery barcode system (BCMA), or a pump IV. The data collection system 6 can receive the medication administration information data 36 by the receiver 42. The information 36 is processed through the message decoder 46 to the microcomputer 47. The software automatically associates the medication administrations with real time using the clock 49. The screen recording system 48 can process the previously recorded data, the time recording, the recording and display the information to the user. The secondary medical device 100 can provide information 50 so that it transfers medication administration information 36 from the registration system 48 to the medical information system 52.
[000174] FIGURE 16B illustrates another variation of a data collection system 6 that can wirelessly receive information 102 from a secondary medical device 100 such as an ECG monitor, an EEG monitor, a blood pressure monitor , a defibrillator, a pulse oximeter, an ETC02 monitor, a BCMA system, or an IV pump. In said configuration, transmitter 104 within medical device 100 transmits information 102 to receiver 42 within data collection system 6. Information 102 is processed through message decoder 46 to microcomputer 47 and is recorded by clock 49. A said information is integrated in time with the medication administration information 36 and is displayed and recorded by the registration system 48. The user can be provided with integrated data from the medication injection field 3 and the medical device 100.
[000175] FIGURE 16C illustrates another variation of a data collection system 6 that can wirelessly receive information 36 from the medication field 3 and a secondary medical device 100 such as an ECG monitor, an EEG monitor, a blood pressure monitor, a defibrillator, a pulse oximeter, an ETC02 monitor, a BCMA system, or an IV pump. In said configuration, the transmitter 34 within the medication field 3 transmits the medication administration information 36 to the receiver 42 within the data collection system 6. The data collection system 6 can be coupled to or form part of a telephone cell 106. Additionally, the data collection system 6 within the cell phone 106 can wirelessly receive information 102 from a secondary medical device 100 such as an ECG monitor, an EEG monitor, a blood pressure monitor, a defibrillator, a pulse oximeter, an ETC02 monitor or an IV pump. Information 102 is processed through message decoder 46 to microcomputer 47 and is recorded by clock 49. Said information 102 is integrated in time with medication administration information 36 and is displayed and recorded by registration system 48. The user it can be provided with integrated data from the drug injection field 3 and the medical device 100. The cell phone 106 can provide information 108 so that it transfers the medication administration information 36 and the medical device information 102 to from the registration system 48 to the medical information system 52.
[000176] FIGURE 17 illustrates a second source of information 224 and a second identification sensor 218. The second source of information 224 can provide supplementary information associated with patient treatment information, medication injections and / or use of medication port 3 in a particular patient. The second identification member 224 may contain optics (one-dimensional barcode, two-dimensional barcode, symbolic information, image or photo), magnetic (magnetic strip on an identification card / badge / ID label) and / or RFID encoded information . The second information source 224 can be illuminated by an optical emitter 231 (LED). Information source 224 may take the form of a one-dimensional bar code 224a, a two-dimensional bar code 224b, a symbolic code 224c ("IΔ í K'ΩΔE" = ID code) or other encoded information. The information can be indicative of one or more of the following: - a patient (photo, patient ID, weight, medical and / or medication conditions / history, height, sex, age, Broselow color), - a sample of the patient (patient ID, blood sample, urine sample, tissue sample, stool sample, other body fluid sample, etc.), - a medical device (device ID, IV pump, ECG monitor, defibrillator, pulse oximeter, blood pressure monitor, etc.), - a healthcare professional (photo, ID code / password, employee ID, name, affiliation, etc.), - a pharmacy record (prescription number, ID patient, formulation, expiration date, instructions and or precautions for administration, pharmacy ID, preparer ID, etc.), - a doctor's order (medication administrations, etc.).
[000177] In some variations, the identification sensor 218 can generate said information when the second source of information 224 is coupled or is located close to the second identification sensor 218. A transmitter 34 can be arranged inside the housing 4 and in communication with / coupled to an identification sensor 218 to wirelessly transmit the information 236 generated by the identification sensor 218 to the remote data collection system 6. The signal from the identification sensor 218 can be processed and prepared for transmission through the circuit sensor 30. The self-contained power source 19 (e.g., battery or battery structure, etc.) can be arranged within housing 4 to provide power for one or more of identification sensor 18, identification sensor 218, send sensor fluid 60, sensor circuit 30, transmitter 34 and indicator 35.
[000178] Aspects of the subject described here can be incorporated into systems, devices, kits (for example, kits with the drug injection field being closed in it), methods, and / or articles depending on the desired configuration. In particular, aspects of the subject described here can be performed on digital electronic circuits, integrated circuits, specially designed ASICs (application-specific integrated circuits), hardware, firmware, computer software, and / or combinations thereof. Said various implementations may include implementation in one or more computer programs that are executable and / or interpretable in a programmable system including at least one programmable processor, which can be of special or general purpose, coupled to receive data and instructions from , and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.
[000179] Said computer programs (also known as programs, software, software applications, applications, components, or codes) include machine instructions for a programmable processor, and can be implemented in a high-level procedure and / or language object-oriented programming, and / or in a set / machine language. As used here, the term "machine-readable medium" refers to any computer program product, apparatus and / or device (for example, magnetic disks, optical disks, memory, programmable logic devices (PLDs)) used to provide machine instructions and / or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal used to provide instructions and / or machine data to a programmable processor.
[000180] The implementations determined in the previous description do not represent all implementations consistent with the subject described here. Instead, they are merely a few examples consistent with aspects related to the subject described. Whenever possible, the same reference numbers will be used throughout the drawings to refer to the same or similar parts.
[000181] Although a few variations have been described in detail above, other modifications or additions are possible. In particular, additional features and / or variations can be provided in addition to those determined herein. For example, in cases when multiple sensors are described and / or illustrated, a single sensor can be used and conversely, when a single sensor is illustrated, multiple sensors can be employed. Still as an additional example, the implementations described above can be directed to various combinations and subcombination of the characteristics and / or combinations and subcombination described of the various additional characteristics described above. In addition, the logical flows described here do not require the particular order shown, or the sequential order, to achieve the desired results. Other modalities may fall within the scope of the following claims.

权利要求:
Claims (25)
[0001]
1. A medication delivery device comprising: a housing (4); a fluid conduit (8, 10) extending within the housing (4) and configured to send a medication within the medication container (20) to a patient via a fluid delivery path (16); a medication port (13) in which one of: (i) defining a cavity extending inwardly from an external surface of the housing (4) and (ii) extending from the external surface of the housing (4) is true, where the medication port (13) is configured to be coupled to a fluid outlet (17) of the medication container (20), the medication port (13) being coupled directly and fluidly to the fluid conduit (8, 10), in which the housing (4) has a size and shape allowing it to be supported by a user's first hand while the user administers medication from the medication container (20) through the medication port ( 13) using a second hand of the user; characterized by the fact that at least one sensor (18, 60) has one of which (i) is arranged inside the housing (4) and (ii) extends from the external surface of the housing (4) is true, in which the at least one sensor generates information that characterizes the administration of the medication for processing by a remote data collection system (6), and in which at least one sensor has a concentric configuration.
[0002]
2. Medication delivery device according to claim 1, characterized by the fact that it additionally comprises: a transmitter (34) inside the housing (4) to transmit information generated by at least one sensor (18, 60) to the remote system data collection (6); and a self-contained power source (43) within the housing (4) driving the at least one sensor (18, 60) and the transmitter (34).
[0003]
3. Medication delivery device, according to claim 2, characterized by the fact that the remote data collection system (6) receives wireless information from the transmitter (34).
[0004]
4. Medication delivery device according to any of the preceding claims, characterized by the fact that the housing (4) is injection molded.
[0005]
5. Medication delivery device according to any of the preceding claims, characterized by the fact that the housing (4) comprises a reusable sub-housing (80) and a disposable sub-housing (82), the disposable sub-housing (82) being used by a single patient and including at least the fluid conduit (8, 10) and a medication port (13), the reusable sub-housing (80) being used by a plurality of patients and including at least one sensor (18, 60 ).
[0006]
6. Medication delivery device according to claim 5, characterized by the fact that the reusable sub-housing (80) is operationally coupled to the disposable sub-housing (82) via the connection interface (84) including one or more than one electrical contact, an RF coupling, an optical coupling, a hydraulic coupling, a mechanical coupling, and a magnetic coupling.
[0007]
Medication delivery device according to any of the preceding claims, characterized in that the fluid conduit (8, 10) includes a first fluid channel (8) and a second fluid channel (10), the first fluid channel (8) extending from the first end (12) to the second end (14), the second fluid channel (10) extending from a distal end and ending at the first fluid channel ( 8) at an intermediate intersection (15) at the first end (12) and the second end (14).
[0008]
8. Medication delivery device according to any one of the preceding claims, characterized by the fact that the fluid conduit (8, 10) is coupled to a set of fluid delivery tube (11); and / or wherein the medication delivery apparatus is integral with a fluid delivery tube assembly (11) and / or configured to be suspended below a fluid source; and / or in which the fluid conduit (8, 10) is configured to be coupled to the parenteral route of medication administration.
[0009]
9. Medication delivery device according to any one of the preceding claims, characterized in that the at least one sensor (18, 60) includes an identification sensor (18) and the medication container (20) includes a information source (24), where the identification sensor (18) reads the information from the information source (24) to generate data to identify the medication in the medication container (20).
[0010]
10. Medication delivery device according to claim 9, characterized by the fact that the information source is arranged close to the fluid outlet (17) from the medication container (20).
[0011]
Medication delivery device according to claim 9 or 10, characterized by the fact that the information source (24) is arranged on a cylindrical or annular surface that is concentric to the fluid outlet (17) from the medication container medication (20) and at least one sensor (18, 60) generates the information that characterizes the administration of the medication when the medication container (20) is attached and / or being attached to a medication port (13).
[0012]
Medication delivery device according to any one of claims 9 to 11, characterized in that the identification sensor (18) includes an image sensor and / or in which the information source (24) is a standard barcode.
[0013]
13. Medication delivery device according to any one of the preceding claims, characterized in that the at least one sensor (18, 60) includes a fluid flow sensor (60) and / or a sensor of the type of medication composition and where the information includes information indicative of an amount of and / or type of fluid sent from the medication container (20) to the patient.
[0014]
14. Medication delivery apparatus according to any one of the preceding claims, characterized by the fact that the at least one sensor (18, 60) includes a medication composition type sensor, and in which the information includes information that characterizes the composition of the medication.
[0015]
15. Medication delivery device, according to any of the preceding claims, characterized by the fact that the longest dimension of the housing (4) is less than or equal to 10 centimeters; and / or where the weight of the medication delivery device is less than 100 grams.
[0016]
16. Medication delivery device, according to any of the preceding claims, characterized by the fact that the remote data collection system (6) is selected from a group comprising: a personal computer, a tablet PC, assistant personal digital, a mobile phone, and a medical device.
[0017]
17. Medication delivery device, according to any of the preceding claims, characterized by the fact that the remote data collection system (6) is a medical device selected from a group comprising: a physiological sensor, a defibrillator , an infusion pump, a barcode medication delivery system (BCMA), a ventilator, and an anesthesia machine.
[0018]
18. Medication delivery device, according to any of the preceding claims, characterized by the fact that the remote data collection system (6) receives, transmits, integrates and / or reports information from and / or to a medical information source (52) selected from a group comprising: a medical device, and a medical information system.
[0019]
19. Medication delivery device, according to claim 18, characterized by the fact that the remote data collection system (6) provides a set of rules that define the conditions to alert and / or guide a health professional using the appliances.
[0020]
20. Medication delivery device, according to any of the preceding claims, characterized by the fact that the remote data collection system (6) provides real-time information to a user including medication information, specific medical data to a procedure instructions and / or protocols for the treatment of the patient.
[0021]
21. Medication delivery device according to any one of the preceding claims, characterized in that the medication container (20) is a needle-free syringe and the fluid outlet (17) from the medication container (20) is one tip of the syringe.
[0022]
22. Medication delivery device according to any one of the preceding claims, characterized by the fact that it additionally comprises: a memory element (38) disposed within the housing (4) to store the information generated by said at least one sensor (18, 60).
[0023]
23. Medication delivery device according to any of the preceding claims, characterized by the fact that it additionally comprises: a complementary data sensor (218) to generate information complementary to the medication administration for processing by the remote data collection system (6).
[0024]
24. Medication delivery device according to any of the preceding claims, characterized by the fact that it comprises a sterile pocket enveloping the medication delivery device, wherein the medication delivery device is provided inside the pocket in a condition sterile.
[0025]
25. Medication delivery device according to any one of the preceding claims, characterized by the fact that it additionally comprises: an indicator element arranged inside the housing (4) to indicate the operational status of the medication delivery device and / or illuminate the medication port (13) providing information to the user.

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同族专利:

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公开号 | 公开日

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US20110112474A1|2011-05-12|

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CN102791310B|2014-12-17|

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US8394053B2|2013-03-12|

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EP2496283A4|2017-10-18|

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BR112012010782B8|2021-06-22|

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CN102791310A|2012-11-21|

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WO2011056888A2|2011-05-12|

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US8355753B2|2013-01-15|

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WO2011056888A3|2011-09-22|

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EP2496283A2|2012-09-12|

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US20110111794A1|2011-05-12|

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-07-16| B06T| Formal requirements before examination [chapter 6.20 patent gazette]|

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2019-12-31| B07A| Technical examination (opinion): publication of technical examination (opinion) [chapter 7.1 patent gazette]|

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2020-07-07| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-11-10| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 10/11/2020, OBSERVADAS AS CONDICOES LEGAIS. |

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2021-06-22| B16C| Correction of notification of the grant|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 03/11/2010, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO |

优先权:

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申请号 | 申请日 | 专利标题

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US12/614,276|US8394053B2|2009-11-06|2009-11-06|Medication injection site and data collection system|

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US12/614,276|2009-11-06|

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US12/765,707|US8355753B2|2009-11-06|2010-04-22|Medication injection site and data collection system|

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US12/765,707|2010-04-22|

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US37097410P| true| 2010-08-05|2010-08-05|

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US61/370,974|2010-08-05|

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US12/938,300|2010-11-02|

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US12/938,300|US8385972B2|2009-11-06|2010-11-02|Medication injection site and data collection system|

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PCT/US2010/055322|WO2011056888A2|2009-11-06|2010-11-03|Medication injection site and data collection system|

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