Blood Analyte Determinations

• US 20070240497A1
• Filed: 02/27/2007
• Published: 10/18/2007
• Est. Priority Date: 11/15/2005
• Status: Abandoned Application

• Current Assignee: John O'Mahony, Mark Ries Robinson, Mike Borrello, Richard Thompson, Stephen Vanslyke, Steve Bernard
• Original Assignee: John O'Mahony, Mark Ries Robinson, Mike Borrello, Richard Thompson, Stephen Vanslyke, Steve Bernard
• Inventors: Vanslyke, Stephen, Borrello, Mike, Robinson, Mark Ries, Thompson, Richard, O'Mahony, John, Bernard, Steve
• Application Number:
  US11/679,835
• Publication Number:
  US 20070240497A1
• Time in Patent Office: Days
• US Class Current: 73/61.410
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150229 Pumps for assisting the blood sampling
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150961 Means for the detection of the presence or absence of a module, a component or an abnormal condition; detection of leaks
• CPC Class Codes: 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, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3663 Flow rate transducers; Flow integrators
• CPC Class Codes: A61M 2005/1404 Keep vein-open rate [KVO], i.e. low flow rate
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: 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

Abstract

The present invention comprises methods and apparatuses that can provide measurement of glucose and other analytes with a variety of sensors without many of the performance-degrading problems of conventional approaches. An apparatus according to the present invention comprises a blood access system, adapted to remove blood from a body and infuse at least a portion of the removed blood back into the body. Such an apparatus also comprises an analyte sensor, mounted with the blood access system such that the analyte sensor measures the analyte in the blood that has been removed from the body by the blood access system. A method according to the present invention comprises removing blood from a body, using an analyte sensor to measure an analyte in the removed blood, and infusing at least a portion of the removed blood back into the body. The use of a non-contact sensor with a closed system creates a system will minimal infection risk.

Claims

1. An apparatus for determining an analyte property in blood, comprising:

a. a brood removal element, adapted to communicate blood with the circulatory system of a patient;

b. an analyte measurement system, adapted to determine a desired property of blood;

c. a sample drive system in fluid communication with the blood removal element and with the analyte measurement system, adapted to receive a blood sample from the blood removal element and transport it to the analyte measurement system.

2. An apparatus as in claim 1, wherein the sample drive system is adapted to receive a blood sample comprising a first volume of blood, and transport at least a portion of the blood sample to the analyte measurement system without requiring substantially more than the first volume of blood to be supplied by the blood removal element.

3. An apparatus as in claim 1, wherein the sample drive system is adapted to supply maintenance fluid to the blood removal element.

4. An apparatus as in claim 1, wherein the sample drive system is in fluid communication with the analyte measurement system via a fluid transport apparatus, and wherein the sample drive system is adapted to move blood into the fluid transport apparatus and then to move a drive material into the fluid transport apparatus such that the drive material pushes the blood to the analyte measurement system.

5. An apparatus as in claim 4, wherein the drive material comprises a maintenance fluid.

6. An apparatus as in claim 5, wherein the maintenance fluid produces a known response from the analyte measurement system.

7. An apparatus as in claim 5, wherein the maintenance substance is a fluid that cleans the analyte measurement system.

8. An apparatus as in claim 5, wherein the maintenance substance is a fluid that provides a calibration measurement using the analyte measurement system.

9. An apparatus as in claim 1, wherein the analyte is glucose, and the analyte measurement device is a glucose measurement device.

10. An apparatus as in claim 4, wherein the drive material comprises polyethylene glycol.

11. An apparatus as in claim 4, wherein the drive material comprises an inert gas or air.

12. An apparatus as in claim 1, wherein the sample drive system is in fluid communication with the analyte measurement system via a fluid transport apparatus, and wherein the sample drive system is adapted to move a plug material into the fluid transport apparatus, then move blood into the fluid transport apparatus and then to move a drive material into the fluid transport apparatus such that the drive material pushes the plug material and the blood to the analyte measurement system.

13. An apparatus as in claim 1, wherein the analyte measurement system comprises one or more of:

electrochemical sensor, microfluidic sensor, micropost sensor, fluorescent measurement device, an enzyme-based sensor, a spectroscopic measurement sensor.

14. A method of determining an analyte property of blood using an apparatus as in claim 1, comprising:

a. Controlling the sample drive system to draw a blood sample from the blood removal element;

b. Controlling the sample drive system to transport a portion of the blood sample to the analyte measurement system;

c. Determining the analyte property using the analyte measurement system.

15. A method as in claim 14, wherein the apparatus further comprises a waste channel in fluid communication with the analyte measurement system, and wherein the method further comprises controlling the sample drive system to transport blood from the analyte measurement system to the waste channel.

16. A method as in claim 14, further comprising controlling the sample drive system to move at least a portion of the blood sample to the patient.

17. A method as in claim 14, further comprising controlling the sample drive system to push a maintenance fluid into blood removal element.

18. A method as in claim 17, wherein the maintenance fluid comprises a saline solution.

19. A method as in claim 14, further comprising operating the sample drive system to prevent fluid pressure in the apparatus from exceeding a predetermined pressure.

20. A method as in claim 14, further comprising, at a time when not operating according to step a), operating the sample drive system to transport maintenance fluid into the blood removal element at a rate sufficient to encourage the access to the patient'"'"'s circulatory system to remain open.

21. A method as in claim 14, wherein the apparatus further comprises a pressure sensor operatively connected to at least one fluid path within the apparatus, and wherein the sample drive system operation is controlled responsive to the pressure sensor to prevent occlusions from damaging the performance of the apparatus.

22. A method as in claim 14, wherein the apparatus further comprises a pressure sensor operatively connected to at least one fluid path within the apparatus, and wherein the presence of air in one or more of the blood removal element, the sample drive system, or the analyte measurement system, is determined from the sample drive system operation and the pressure sensor.

23. A method as in claim 22, wherein the presence of air is determined from the dynamic compliance of fluid in the apparatus.

24. A method of determining an analyte property of blood using an apparatus as in claim 4, comprising:

a. Controlling the sample drive system to draw a blood sample from the blood removal element;

b. Controlling the sample drive system to transport a portion of the blood sample into the fluid transport apparatus;

c. Controlling the sample drive system to transport drive material into the fluid transport apparatus and displace the blood therein such that the blood therein reaches the analyte measurement system;

d. Determining the analyte property using the analyte measurement system.

25. A method as in claim 24, wherein the drive material comprises a material that produces a predetermined response from the analyte measurement system, and wherein the method further comprises operating the sample drive system to transport drive material into the fluid transport apparatus such that drive material reaches the analyte measurement system, and determining the actual response of the analyte measurement system to the drive material therein, and using a comparison of the actual response to the predetermined response to calibrate measurements of blood with the analyte measurement system.

26. A method of determining an analyte property of blood using an apparatus as in claim 12, comprising

a. Controlling the sample drive system to draw a blood sample from the brood removal element;

b. Controlling the sample drive system to move a plug material into the fluid transport apparatus;

then

c. Controlling the sample drive system to transport a portion of the blood sample into the fluid transport apparatus;

d. Controlling the sample drive system to transport drive material into the fluid transport apparatus and displace the blood therein such that the plug material and then the blood therein reaches the analyte measurement system;

e. Determining the analyte property using the analyte measurement system.

27. An apparatus as in claim 1, wherein the sample drive system comprises:

a. A first fluid transport apparatus, in fluid communication with the blood removal element;

b. A second fluid transport apparatus, in fluid communication with the first fluid transport apparatus and with the blood removal element;

c. A sample system, in fluid communication with the first fluid transport apparatus and adapted to draw blood from the blood removal element into the first fluid transport apparatus, and adapted to move blood from the first fluid transport apparatus into the second fluid transport apparatus;

d. A third fluid transport apparatus;

e. A flow control element, mounted so as to receive fluid from the second fluid transport apparatus and deliver fluid to the third fluid transport apparatus;

f. A waste channel, in fluid communication with the analyte measurement system;

g. A drive system, in fluid communication with the third fluid transport apparatus and adapted to move fluid in the third fluid transport apparatus away from the flow control element and to the analyte measurement system and waste channel.

28. An apparatus as in claim 27, wherein the drive system is further adapted to introduce a plug material into the third fluid transport apparatus.

29. An apparatus as in claim 28, wherein the plug material comprises polyethylene glycol.

30. An apparatus as in claim 28, wherein the plug material comprises an inert gas or air.

31. An apparatus as in claim 27, wherein the sample system comprises (j) a source of maintenance fluid and (k) a pump connected between the first fluid transport apparatus and a source of maintenance fluid.

32. An apparatus as in claim 27, wherein the sample system comprises (j) a source of maintenance fluid, (k) a waste channel, (l) a pump in fluid communication with the first fluid transport apparatus, and in fluid communication with the source of maintenance fluid such that the pump can transport maintenance fluid to the first fluid transport apparatus, and in fluid communication with the waste channel such that the pump can transport fluid from the first fluid transport apparatus to the waste channel.

33. An apparatus as in claim 32, wherein the sample system further comprises an air detector mounted with the first fluid transport apparatus.

34. An apparatus as in claim 32, wherein the sample system comprises a pressure sensor mounted with the first fluid transport apparatus.

35. An apparatus as in claim 28, wherein the drive system comprises a pump connected between a source of plug material and the third fluid transport apparatus.

36. An apparatus as in claim 27, wherein the drive system comprises (j) a source of plug material, (k) a source of drive fluid, and (l) a drive pump in fluid communication with the third fluid transport apparatus, and with the source of plug material such that the drive pump can transport plug material from the source of plug material to the third fluid transport apparatus, and in fluid communication with the source of drive fluid such that the drive pump can transport drive fluid from the source of drive fluid to the third fluid transport apparatus.

37. An apparatus as in claim 36, wherein the drive fluid comprises air.

38. A method of determining an analyte property of blood using an apparatus as in claim 27, comprising:

a. Controlling the sample system to draw blood from the circulatory system of a patient into the first fluid transport apparatus;

b. Controlling the sample system to move at least some of the blood in the first fluid transport apparatus into the second fluid transport apparatus;

c. Controlling the sample system to move at least some of the blood in the second fluid transport system into the third fluid transport apparatus;

d. Controlling the drive system to move at least some of the blood in the third fluid transport apparatus to the analyte measurement system;

e. Determining the analyte property of the blood using the analyte measurement system.

39. A method as in claim 38, further comprising controlling the drive system to move blood from the third fluid transport apparatus to the waste channel.

40. A method as in claim 38, further comprising controlling the sample system to move blood from the first fluid transport apparatus to the patient.

41. A method as in claim 38, further comprising controlling the sample system to push blood from the first fluid transport apparatus to the patient, and controlling the sample system to push maintenance fluid into the first fluid transport apparatus.

42. A method of determining an analyte property of blood using an apparatus as in claim 28, comprising:

a. Controlling the sample system to draw blood from the circulatory system of a patient into the first fluid transport apparatus;

b. Controlling the sample system to move blood from the first fluid transport apparatus into the second fluid transport apparatus;

c. Controlling the drive system to move a plug of plug material into the third fluid transport apparatus;

d. Controlling the sample system to move at least some of the blood in the second fluid transport system into the third fluid transport apparatus, pushing the plug material into the third fluid transport apparatus ahead of the blood;

e. Controlling the drive system to move the blood and plug in the third fluid transport apparatus to the analyte measurement system;

f. Determining the analyte property of the blood using the analyte measurement system.

43. A method as in claim 42, further comprising controlling the drive system to move blood and the plug from the third fluid transport apparatus to the waste channel.

44. A method as in claim 42, further comprising controlling the sample system to move blood from the first fluid transport apparatus to the patient.

45. A method as in claim 42, further comprising controlling the sample system to push maintenance fluid into the first fluid transport apparatus.

46. A method as in claim 42, further comprising controlling the drive system to move a second plug into the third fluid transport apparatus after the sample system has moved blood into the third fluid transport apparatus.

47. A method as in claim 38, wherein the apparatus further comprises a source of maintenance fluid that produces a predetermined response from the analyte measurement system in fluid communication with the sample system, and wherein the method further comprises controlling the sample system to push maintenance fluid into the third fluid transport apparatus, and controlling the drive system to transport the maintenance fluid to the analyte measurement system, and determining the response of the analyte measurement system to the maintenance fluid, and correcting determinations of analyte properties of blood to correct for analyte measurement system performance indicated by a comparison of the analyte measurement system response to the maintenance fluid with the known response of the analyte measurement system.

48. A method as in claim 38, further comprising operating the sample system to prevent fluid pressure in the first fluid transport apparatus from exceeding a predetermined pressure.

49. A method as in claim 38, further comprising, at a time when not operating according to steps a) or b), operating the sample system to transport maintenance fluid into the blood removal element at a rate sufficient to encourage the access to the patient'"'"'s circulatory system to remain open.

50. A method as in claim 38, wherein the apparatus further comprises a pressure sensor operatively connected to at least one of the first and second fluid transport apparatuses, and wherein the sample system operation is controlled responsive to the pressure sensor to prevent occlusions from damaging the performance of the system.

51. A method as in claim 38, wherein the apparatus further comprises a pressure sensor operatively connected to at least one of the first and second fluid transport apparatuses, and wherein the presence of air in one or more of the blood removal element, the first fluid transport apparatus, or the second fluid transport apparatus, is determined from the pump operation and the pressure sensor.

52. A method as in claim 51, wherein the presence of air is determined from the dynamic compliance of the fluid in the apparatus.

53. A blood access system comprising:

a. a first junction in fluid communication with a catheter;

b. a pressure measurement device in fluid communication with a first side of the first junction;

c. a first pump having a first side in fluid communication with the first side of the first junction;

d. an air detector mounted intermediate the first side to the first junction in fluid communication with the first side of the first pump;

e. a second junction having a first side in fluid communication with a second side of the first pump;

f. a first valve having a first side in fluid communication with a second side of the second junction;

g. a waste channel having a first side in fluid communication with a second side of the first valve;

h. a second valve having a first side in fluid communication with a second side of the waste channel;

i. a second pump having a first side in fluid communication with a second side of the second valve;

j. an analyte sensor having a first side in fluid communication with a second side of the second pump;

k. a third junction having a first side in fluid communication with a second side of the analyte sensor;

l. a third valve having a first side in fluid communication with a second side of the third junction;

m. a fourth valve having a first side in fluid communication with a second side of the third valve;

n. a pressure relief valve in fluid communication with the second side of the third valve;

o. a pump in fluid communication with the second side of the third valve;

p. a fifth valve having a first side in fluid communication with a third side of the third junction and a second side in fluid communication with a second side of the first junction.