# US 2010/0168535 A1 · Methods and apparatuses related to blood analyte measurement system > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2010/0168535 A1 - Document ID: US20100168535A1 - Status: Published application - Kind: A1 - Application number: 12/714,100 - Filed: 2010-02-26 - Published: 2010-07-01 - Earliest claimed: 2006-04-12 - Inventors: Mark Ries Robinson; William R. Patterson; Richard P. Thompson; Shonn Hendee; James H. Macemon - Web page: https://patentgrep.com/patent/US20100168535A1 ## CPC - A61B 5/14532: {for measuring glucose, e.g. by tissue impedance measurement} - A61B 5/15003: {for venous or arterial blood} - A61B 5/150221: {Valves} - A61B 5/150229: {Pumps for assisting the blood sampling} - A61B 5/150236: {Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood} - A61B 5/150244: {Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood} - A61B 5/150755: {Blood sample preparation for further analysis, e.g. by separating blood components or by mixing} - A61B 5/150992: {Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; Blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings or valves} - A61B 5/153: {Devices} specially adapted for taking samples of venous or arterial blood, e.g. with syringes - A61B 5/150389: {Hollow piercing elements, e.g. canulas, needles, for piercing the skin} - A61B 5/150503: {Single-ended needles (hollow piercing element tip design A61B5/150396)} - A61M 5/16831: {Monitoring, detecting, signalling or eliminating infusion flow anomalies (low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066)} - A61M 2005/1404: {Keep vein-open rate [KVO], i.e. low flow rate} - A61M 2205/3306: Optical measuring means - A61M 2205/331: used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection - A61M 2230/201: Glucose concentration - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract The present invention relates to a blood analyte measurement system for the procurement of blood samples for measurement of blood properties such as analyte concentration or analyte presence. A blood access system can be coupled with a measurement system such as an electrochemical sensor, and can also be used with other measurement modalities. Embodiments of the present invention can facilitate accurate measurement of blood glucose by the clinician in a sterile manner. Embodiments of the present invention can also enable the calibration of the sensor at one or more calibration points. One desired analyte of measurement is glucose for the effective implementation of glycemic control protocols. Embodiments of the present invention can also be used for the measurement of other analytes such as arterial blood gases, lactate, hemoglobin, potassium and urea. Additionally, embodiments of the present invention can function effectively on a variety of blood access points and specifically enables glucose monitoring in an existing arterial line that is already in place for hemodynamic monitoring. The present invention does not consume a significant amount of blood. Some embodiments of the present invention can re-infuse the blood into the patient, which can facilitate operation of the system in a sterile manner. ## Claims ### Claim 1 An apparatus for measuring an analyte in blood taken from a patient, comprising: a. A patient interface device, capable of interfacing with the circulatory system of a patient; b. An analyte sensor having first and second ports, with the first port in fluid communication with the patient interface device; c. A flow generation and reservoir system having first and second ports, with the first port in fluid communication with second port of the analyte sensor; and d. A first fluid source, mounted such that it can be placed in fluid communication with the second port of the flow generation and storage system, wherein the first fluid source provides a first fluid having a first predetermined analyte concentration. ### Claim 2 (depends on 1) An apparatus as in claim 1, further comprising a second fluid source mounted such that it can be placed in fluid communication with the second port of the flow generation and reservoir system, wherein the second fluid source provides a second fluid having a second predetermined analyte concentration, different from the first analyte concentration. ### Claim 3 (depends on 2) An apparatus as in claim 2, further comprising a first fluid selection system in fluid communication with the first and second fluid sources and with the second port of the flow generation and reservoir system, wherein the first fluid selection system has first and second configurations, wherein in the first configuration only the first fluid is supplied to the flow generation and reservoir system, and in the second configuration only the second fluid is supplied to the flow generation and reservoir system. ### Claim 4 (depends on 1) An apparatus as in claim 1, further comprising a plurality of additional fluid sources mounted such that each additional fluid source can be placed in fluid communication with the second port of the flow generation and reservoir system, wherein each additional fluid source provides an additional fluid having a predetermined analyte concentration, wherein the analyte concentration of the first fluid and of the additional fluids are different from each other. ### Claim 5 (depends on 4) An apparatus as in claim 4, further comprising a fluid selection system in fluid communication with the first fluid source and with each of the additional fluid sources and with the second port of the flow generation and reservoir system, and wherein the fluid control system has a plurality of configurations, wherein for the first fluid source and for each of the additional fluid sources there is a configuration of the first fluid selection system that allows only said fluid source to supply fluid to the flow generation and reservoir system. ### Claim 6 (depends on 1) An apparatus as in claim 1, further comprising a second fluid source mounted such that it can be placed in fluid communication with the second port of the analyte sensor, wherein the second fluid source provides a second fluid having a second predetermined analyte concentration, different from the first analyte concentration. ### Claim 7 (depends on 6) An apparatus as in claim 6, further comprising a first fluid selection system in fluid communication with the second port of the analyte sensor, with the first port of the flow generation and reservoir system, and with the second fluid source, wherein the fluid selection system has a first configuration in which the second port of the analyte sensor is in fluid communication with the second port of the flow generation and reservoir system and not with the second fluid source, and a second configuration in which the first port of the flow generation and reservoir system is in fluid communication with the second fluid source and not with the second port of the analyte sensor. ### Claim 8 (depends on 7) An apparatus as in claim 7, wherein the first fluid selection system comprises one or more multiway valves, or a plurality of shutoff valves, or a plurality of pinch clamps, or a combination thereof. ### Claim 9 (depends on 2) An apparatus as in claim 2, further comprising a waste channel mounted such that it can be placed in fluid communication with the first port of the analyte sensor. ### Claim 10 (depends on 9) An apparatus as in claim 9, further comprising a first fluid selection system in fluid communication with the first port of the analyte sensor, with the patient interface device, and with the waste channel, wherein the first fluid selection system has a first configuration in which the first port of the analyte sensor is in fluid communication with the patient interface device and not with the waste channel, and a second configuration in which the first port of the analyte sensor is in fluid communication with the waste channel and not with the patient interface device. ### Claim 11 (depends on 6) An apparatus as in claim 6, further comprising a waste channel mounted such that it can be placed in fluid communication with the first port of the analyte sensor. ### Claim 12 (depends on 11) An apparatus as in claim 11, further comprising a second fluid selection system in fluid communication with the first port of the analyte sensor, with the patient interface device, and with the waste channel, wherein the second fluid selection system has a first configuration in which the first port of the analyte sensor is in fluid communication with the patient interface device and not with the waste channel, and a second configuration in which the first port of the analyte sensor is in fluid communication with the waste channel and not with the patient interface device. ### Claim 13 (depends on 1) An apparatus as in claim 1, further comprising a first access port in fluid communication with the first port of the analyte sensor and allowing fluid communication with the first port of the analyte sensor, and further comprising a second access port in fluid communication with the second port of the analyte sensor allowing fluid communication with the second port of the analyte sensor. ### Claim 14 (depends on 1) An apparatus as in claim 1, further comprising a flow divider in fluid communication with the first port of the analyte sensor and with the second port of the analyte sensor. ### Claim 15 (depends on 14) An apparatus as in claim 14, wherein the fluid pathway from the patient interface device to the first port of the analyte sensor has a first flow cross-section, the fluid pathway through the analyte sensor has a second flow cross-section, and the fluid bypass has a third flow cross-section, wherein the first flow cross-section is larger than the third flow cross-section, and the third flow cross-section is larger than the second flow cross-section. ### Claim 16 (depends on 1) An apparatus as in claim 1, wherein the flow generation and reservoir system comprises a syringe pump having first and second ports, the first port in fluid communication with the second port of the analyte sensor and the second port in fluid communication with the first fluid source. ### Claim 17 (depends on 2) An apparatus as in claim 2, wherein the flow generation and reservoir system comprises a syringe pump. ### Claim 18 (depends on 6) An apparatus as in claim 6, wherein the flow generation and reservoir system comprises a syringe pump. ### Claim 19 (depends on 1) An apparatus as in claim 1, wherein the flow generation and reservoir system comprises a peristaltic pump having first and second ports, and a reservoir having first and second ports, wherein the first port of the peristaltic pump is in fluid communication with the second port of the reservoir, and wherein the first port of the reservoir is in fluid communication with the analyte sensor, and wherein the second port of the peristaltic pump is mounted such that it can be placed in fluid communication with the first fluid source. ### Claim 20 (depends on 19) An apparatus as in claim 19, wherein the reservoir comprises one or more of a bag, a flexible pillow, a syringe, a bellows device, a device that can be expanded through pressure, and an expandable fluid column. ### Claim 21 (depends on 2) An apparatus as in claim 2, wherein the flow generation and reservoir system comprises a peristaltic pump having first and second ports, and a reservoir having first and second ports, wherein the first port of the reservoir comprises the first port of the flow generation and reservoir system, the second port of the peristaltic port comprises the second port of the flow generation and reservoir system, and the first port of the peristaltic pump is in fluid communication with the second port of the reservoir. ### Claim 22 (depends on 21) An apparatus as in claim 21, wherein the reservoir comprises one or more of a bag, a flexible pillow, a syringe, a bellows device, a device that can be expanded through pressure, and an expandable fluid column. ### Claim 23 (depends on 6) An apparatus as in claim 6, wherein the flow generation and storage reservoir comprises a peristaltic pump having first and second ports, and a reservoir having first and second ports, wherein the first port of the reservoir comprises the first port of the flow generation and reservoir system, the second port of the peristaltic port comprises the second port of the flow generation and reservoir system, and the first port of the peristaltic pump is in fluid communication with the second port of the reservoir. ### Claim 24 (depends on 23) An apparatus as in claim 23, wherein the reservoir comprises one or more of a bag, a flexible pillow, a syringe, a bellows device, a device that can be expanded through pressure, and an expandable fluid column. ### Claim 25 (depends on 1) An apparatus as in claim 1, wherein the flow generation and reservoir system comprises a peristaltic pump having first and second ports, and a reservoir having a first port, wherein the first port of the peristaltic pump comprises the first port of the flow generation and reservoir system, and wherein the second port of the peristaltic pump is in fluid communication with the first port of the reservoir. ### Claim 26 (depends on 1) An apparatus as in claim 1, further comprising a second fluid source, and wherein the flow generation and reservoir system comprises a first syringe pump and a second syringe pump, wherein the first syringe pump is in fluid communication with the first fluid source, and wherein the second syringe pump is in fluid communication with the second fluid source, and wherein the first syringe pump and second syringe pump are each in fluid communication with the second port of the analyte sensor. ### Claim 27 (depends on 26) An apparatus as in claim 26, wherein the first syringe pump is connected to the second port of the analyte sensor through a first flow interrupting device, and wherein the second syringe pump is connected to the second port of the analyte sensor through a second flow interrupting device. ### Claim 28 (depends on 1) An apparatus as in claim 1, further comprising a second fluid source, and wherein the flow generation and reservoir system comprises a first reservoir and a second reservoir and a peristaltic pump having first and second ports, wherein the first reservoir is in fluid communication with the first fluid source, and wherein the second reservoir is in fluid communication with the second fluid source, and wherein the first reservoir and second reservoirs are each in fluid communication with the second port of the peristaltic pump, and wherein the first port of the peristaltic pump is in fluid communication with the second port of the analyte sensor. ### Claim 29 (depends on 28) An apparatus as in claim 28, wherein the first reservoir is connected to the second port of the peristaltic pump through a first flow interrupting device, and wherein the second reservoir is connected to the second port of the peristaltic pump through a second flow interrupting device. ### Claim 30 (depends on 1) An apparatus as in claim 1, further comprising a pressure monitor in fluid communication with the circulatory system of a patient. ### Claim 31 (depends on 2) An apparatus as in claim 2, further comprising a pressure monitor in fluid communication with the circulatory system of a patient. ### Claim 32 (depends on 6) An apparatus as in claim 6, further comprising a pressure monitor in fluid communication with the circulatory system of a patient. ### Claim 33 (depends on 1) A method of measuring an analyte concentration, comprising: a. Providing an apparatus as in claim 1; b. Operating the flow generation and reservoir system to place the first fluid in operative contact with the analyte sensor; c. Determining a calibration responsive to the analyte sensor output while in operative contact with the first fluid; d. Operating the flow generation and storage system to place blood from the patient in operative contact with the analyte sensor; e. Determining the analyte concentration from the analyte sensor output while in operative contact with blood and from the calibration. ### Claim 34 (depends on 2) A method of measuring an analyte concentration, comprising: a. Providing an apparatus as in claim 2; b. Operating the flow generation and reservoir system to place the first fluid in operative contact with the analyte sensor; c. Operating the flow generation and storage system to place the second fluid in operative contact with the analyte sensor; d. Determining a calibration responsive to the analyte sensor output while in operative contact with the first fluid and the analyte sensor output while in operative contact with the second fluid; e. Operating the flow generation and storage system to place blood from the patient in operative contact with the analyte sensor; f. Determining the analyte concentration from the analyte sensor output while in operative contact with blood and from the calibration. ### Claim 35 (depends on 6) A method of measuring an analyte concentration, comprising: a. Providing an apparatus as in claim 6; b. Operating the flow generation and reservoir system to place the first fluid in operative contact with the analyte sensor; c. Operating the flow generation and reservoir system to place the second fluid in operative contact with the analyte sensor; d. Determining a calibration responsive to the analyte sensor output while in operative contact with the first fluid and the analyte sensor output while in operative contact with the second fluid; e. Operating the flow generation and reservoir system to place blood from the patient in operative contact with the analyte sensor; f. Determining the analyte concentration from the analyte sensor output while in operative contact with blood and from the calibration. ### Claim 36 An apparatus for measuring an analyte in blood taken from a patient, comprising: a. A patient interface device, capable of interfacing with the circulatory system of a patient; b. An analyte sensor having first and second ports, with the first port in fluid communication with the patient interface device; c. A flow generation and reservoir system having first and second ports, with the first port in fluid communication with second port of the analyte sensor; d. A first fluid source, mounted such that it can be placed in fluid communication with the second port of the flow generation and reservoir system, wherein the first fluid source provides a first fluid having a first predetermined analyte concentration; and e. A second fluid source, mounted such that it can be placed in fluid communication with the second port of the analyte sensor, wherein the second fluid source provides a second fluid having a second predetermined analyte concentration, where the second predetermined analyte concentration is different than the first predetermined analyte concentration. ### Claim 37 An apparatus for the measurement of an analyte, comprising: a. A patient interface device capable of interfacing with the circulatory system of a patient; b. An analyte sensor having first and second ports, with the first port in fluid communication with the patient interface device; c. A flow generation device having first and second ports, with the first port in fluid communication with second port of the analyte sensor; d. A waste channel in fluid communication with the second port of the flow generation device through a first flow control device that allows fluid flow from the flow generation device to the waste channel but substantially prevents fluid from the waste channel to the flow generation device; e. A first fluid source, mounted such that it can be placed in fluid communication with the second port of the flow generation device through a second flow control device that allows fluid flow from the first fluid source to the flow generation device but substantially prevents fluid from the flow generation device to the first fluid source, wherein the first fluid source provides a first fluid having a first predetermined analyte concentration. ### Claim 38 (depends on 37) An apparatus as in claim 37, further comprising a second fluid source, mounted such that it can be placed in fluid communication with the second port of the flow generation device through a third flow control device that allows fluid flow from the second fluid source to the flow generation device but substantially prevents fluid from the flow generation device to the second fluid source, wherein the second fluid source provides a first fluid having a second predetermined analyte concentration, and where the second predetermined analyte concentration is different than the first predetermined analyte concentration. ### Claim 39 (depends on 38) An apparatus as in claim 38, further comprising a first fluid selection system in fluid communication with the first and second fluid sources and with the second port of the flow generation device, wherein the first fluid selection system has first and second configurations, wherein in the first configuration only the first fluid is supplied to the flow generation device, and in the second configuration only the second fluid is supplied to the flow generation device. ### Claim 40 (depends on 37) An apparatus as in claim 37, further comprising a second fluid source mounted such that it can be placed in fluid communication with the second port of the analyte sensor, wherein the second fluid source provides a second fluid having a second predetermined analyte concentration, different from the first analyte concentration. ### Claim 41 (depends on 40) An apparatus as in claim 40, further comprising a first fluid selection system in fluid communication with the second port of the analyte sensor, with the first port of the flow generation device, and with the second fluid source, wherein the fluid selection system has a first configuration in which the second port of the analyte sensor is in fluid communication with the second port of the flow generation device and not with the second fluid source, and a second configuration in which the first port of the flow generation device is in fluid communication with the second fluid source and not with the second port of the analyte sensor. ### Claim 42 (depends on 37) A method of measuring an analyte, comprising: a. Providing an apparatus as in claim 37; b. Placing the patient interface device in fluid communication with the vascular system of a patient; c. Operating the flow generation device to place the first fluid in operative contact with the analyte sensor and determining a response of the analyte sensor responsive to the first fluid; d. Operating the flow generation device to move fluid from the analyte sensor to the waste channel and to place blood from the patient in operative contact with the analyte sensor and determining a response of the analyte sensor responsive to the blood; and e. Determining an analyte measurement from the responses of the analyte sensor. ### Claim 43 (depends on 38) A method of measuring an analyte, comprising: a. Providing an apparatus as in claim 38; b. Placing the patient interface device in fluid communication with the vascular system of a patient; c. Operating the flow generation device to place the first fluid in operative contact with the analyte sensor and determining a response of the analyte sensor responsive to the first fluid; d. Operating the flow generation device to place the second fluid in operative contact with the analyte sensor and determining a response of the analyte sensor responsive to the second fluid; e. Operating the flow generation device to move fluid from the analyte sensor to the waste channel and to place blood from the patient in operative contact with the analyte sensor and determining a response of the analyte sensor responsive to the blood; and f. Determining an analyte measurement from the responses of the analyte sensor. ### Claim 44 (depends on 40) A method of measuring an analyte, comprising: a. Providing an apparatus as in claim 40; b. Placing the patient interface device in fluid communication with the vascular system of a patient; c. Operating the flow generation device to place the first fluid in operative contact with the analyte sensor and determining a response of the analyte sensor responsive to the first fluid; d. Operating the flow generation device to place the second fluid in operative contact with the analyte sensor and determining a response of the analyte sensor responsive to the second fluid; e. Operating the flow generation device to move fluid from the analyte sensor to the waste channel and to place blood from the patient in operative contact with the analyte sensor and determining a response of the analyte sensor responsive to the blood; and f. Determining an analyte measurement from the responses of the analyte sensor. ### Claim 45 (depends on 34) A method as in claim 34, wherein the analyte sensor is placed in operative contact with the second fluid after being in operative contact with the first fluid and before being in operative contact with blood, and wherein the analyte concentration of the second fluid is less than the analyte concentration of the first fluid. ### Claim 46 (depends on 35) A method as in claim 35, wherein the analyte sensor is placed in operative contact with the second fluid after being in operative contact with the first fluid and before being in operative contact with blood, and wherein the analyte concentration of the second fluid is less than the analyte concentration of the first fluid. ### Claim 47 (depends on 1) An apparatus as in claim 1, further comprising an access port allowing extraction of blood from the system. ### Claim 48 (depends on 1) An apparatus as in claim 1, further comprising an access port allowing extraction of blood from the system between the patient interface device and the analyte sensor. ### Claim 49 (depends on 1) An apparatus as in claim 1, further comprising an access port allowing extraction of blood from the system between the analyte sensor and the flow generation device.