FLUID COMPONENT ANALYSIS SYSTEM AND METHOD FOR GLUCOSE MONITORING AND CONTROL

• US 20090131861A1
• Filed: 10/10/2008
• Published: 05/21/2009
• Est. Priority Date: 10/10/2007
• Status: Active Grant

• Current Assignee: Insulet Corporation
• Original Assignee: OptiScan Biomedical Corporation
• Inventors: Braig, James R., Keenan, Richard, Rule, Peter, Seetharaman, Mahesh, Rivas, Gil
• Granted Patent: US 7,972,296 B2
• Time in Patent Office: Days
• US Class Current: 604/66
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/14557 specially adapted to extracorporeal circuits
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• 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 5/150267 Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/150862 intermediate range, e.g. within room or building
• 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: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/7475 : User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 2005/1404 : Keep vein-open rate [KVO], i.e. low flow rate
• CPC Class Codes: A61M 2005/14208 : with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection

Abstract

Disclosed are methods and apparatus for determining analyte concentration in a sample such as bodily fluid. Systems and methods disclosed herein can also include a treatment dosing system to infuse or inject a treatment drug (e.g. insulin or glucose) and provide glycemic control. The dose of the treatment drug may be based on the concentration of the analyte or the average value for the concentration of the analyte and/or the rate of change of the value of the concentration of the analyte.

Claims

1. An analyte detection and treatment dosing system comprising:

a fluid transport network configured to provide fluid communication with a body fluid in a patient through a patient end;

at least one pump system coupled to the fluid transport network, the pump system having a sampling mode in which the pump system is operable to withdraw a sample of bodily fluid from the patient end and transport said sample of bodily fluid toward the body fluid analyzer, and an infusion mode in which the pump system is operable to transport an infusion fluid to the patient;

a body fluid analyzer accessible via the fluid transport network, the body fluid analyzer configured to measure a characteristic of at least one analyte in the body fluid and determine the concentration of the at least one analyte from the measured characteristic; and

a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system including a treatment dosing protocol stored in a computer memory and configured to automatically determine a recommended dose of an infusion substance configured to provide glycemic control, wherein the body fluid analyzer determines the recommended dose based at least in part on the measured concentration of the analyte and the stored treatment dosing protocol,

the treatment dosing system comprising a treatment pump having a variable pump rate to deliver the recommended dose of the infusion substance to the patient.

2. The analyte detection system of claim 1, wherein the treatment pump is configured to deliver infusion substance continuously at a basal rate through the patient end.

3. The analyte detection system of claim 1, wherein the treatment pump is configured to deliver the recommended dose of the infusion substance as a bolus injection through the patient end.

4. The analyte detection system of claim 1, wherein the treatment pump is configured to deliver the infusion substance continuously at a basal rate combined with intermittent bolus injections of the recommended dose.

5. The analyte detection system of claim 4, wherein a time interval between two bolus injections is determined based at least in part on the recommended dose and the basal rate.

6. The analyte detection system of claim 1, wherein the treatment pump is configured to deliver the recommended dose of the infusion substance to the patient through said patient end during the infusion mode of the pump system.

7. The analyte detection system of claim 1, wherein the body fluid analyzer comprises a spectroscopic analyzer.

8. The analyte detection system of claim 1, wherein the body fluid analyzer comprises an electrochemical analyzer.

9. The analyte detection system of claim 1, wherein said at least one analyte comprises glucose.

10. The analyte detection system of claim 1, wherein the infusion substance comprises a substance selected from the group consisting of insulin and dextrose.

11. The analyte detection system of claim 1, wherein the pump unit is selected from a group consisting of:

volumetric pump, syringe pump, peristaltic pump, vacuum pump, electrical pump, mechanical pump or hydraulic pump.

12. The analyte detection system of claim 1, wherein the dosing protocol comprises a tight glycemic control protocol.

13. The analyte detection system of claim 1, wherein the treatment dosing system is configured to access a measurement database, calculate an average concentration of the analyte based on one or more determinations by the body fluid analyzer of the concentration of the analyte and determine the recommended dose for the infusion substance based on the average concentration of the analyte.

14. The analyte detection system of claim 1, wherein the treatment dosing system is configured to access a measurement database, calculate a rate of change in the concentration of the analyte and determine the recommended dose for the infusion fluid based on the rate of change in the concentration of the analyte.

15. The analyte detection system of claim 1, further comprising a user interface including a dosing graphic that indicates information related to the recommended dose, an actual dose of the infusion substance, or both.

16. The analyte detection system of claim 15, wherein the user interface includes an input element configured to accept user input, the user interface further configured to adjust the actual dose of the infusion fluid based at least in part on the user input.

17. The analyte detection system of claim 16, wherein the user interface comprises a touchscreen display and the input element comprises a button on the touchscreen.

18. An analyte detection and treatment dosing system comprising:

a fluid transport network configured to provide fluid communication with a body fluid in a patient through a patient end;

at least one pump system coupled to the fluid transport network, the pump system having a sampling mode in which the pump system is operable to withdraw a sample of bodily fluid from the patient end and transport said sample of bodily fluid towards the body fluid analyzer, and an infusion mode in which the pump system is operable to transport an infusion fluid to the patient;

a body fluid analyzer accessible via the fluid transport network, the body fluid analyzer configured to measure a characteristic of at least one analyte in the body fluid and determine the concentration of the at least one analyte from the measured characteristic; and

a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system including a treatment dosing protocol stored in a computer memory and configured to automatically determine a recommended dose of an infusion substance configured to provide glycemic control, wherein the recommended dose is determined based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and the treatment dosing protocol,

the treatment dosing system comprising a basal delivery system and a bolus injection system, both systems configured to deliver infusion substances to the patient through said patient end and through the same intravenous access line.

19. The analyte detection system of claim 18, wherein the basal delivery system is configured to deliver infusion substance continuously at a basal rate through the patient end.

20. The analyte detection system of claim 18, wherein the bolus injection system is configured to deliver the recommended dose of the infusion substance as a bolus injection through the patient end.

21. The analyte detection system of claim 18, wherein the basal delivery system and the bolus injection system are controlled by a single treatment pump having a variable pump rate.

22. The analyte detection system of claim 18, wherein the basal delivery system and the bolus injection system have separate pumps, but each pump cooperates to infuse through the same intravenous access line.

23. An analyte detection and control system to determine and regulate the concentration of one or more analytes in a sample of bodily fluid, the system comprising:

a control system;

an analyte detector configured to measure a characteristic of at least one analyte in the sample of bodily fluid and determine a concentration of the analyte in the sample based on the measured characteristic;

a fluid handling system operatively coupled to the analyte detector, said fluid handling system comprising a fluid passageway in communication with a patient through a patient end;

a pump unit configured to engage the fluid handling system and draw a sample of bodily fluid from the patient periodically at draw intervals of less than 1 hour for analysis;

a source of infusion fluid configured to adjust glycemic levels in the patient, said infusion fluid source in fluid communication with the fluid handling system; and

a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system including a treatment dosing protocol and configured to determine a recommended dose for the infusion fluid, wherein the recommended dose is determined based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and the treatment dosing protocol.

24. The system of claim 23, wherein the infusion fluid comprises glucose or Dextrose.

25. The analyte detection and control system of claim 23, wherein the infusion fluid comprises insulin.

26. The analyte detection and control system of claim 23 configured to draw a sample of bodily fluid at draw intervals of 45 minutes or less.

27. The analyte detection and control system of claim 23 configured to draw a sample of bodily fluid at draw intervals of 30 minutes or less.

28. The analyte detection and control system of claim 23 configured to draw a sample of bodily fluid at draw intervals of 15 minutes or less.

29. The analyte detection and control system of claim 23, wherein the infusion source is located within a short distance of the patient to allow infusion of the infusion fluid at intervals of less than the draw intervals.

30. The analyte detection and control system of claim 23, wherein the infusion source is located within a short fluid distance of the site where the patient end of the fluid passageway interfaces with the patient.

31. The analyte detection and control system of claim 23, wherein the infusion source delivers infusion fluid to the patient within 1 minute of receiving an instruction from the control system.

32. The analyte detection and control system of claim 23, wherein the infusion source delivers infusion fluid to the patient within 1-5 minutes of receiving an instruction from the control system.

33. The analyte detection and control system of claim 23, wherein the infusion source delivers infusion fluid to the patient within 1-10 minutes of receiving an instruction from the control system.

34. A method of analyzing an analyte in the body fluid of a patient, the method comprising:

placing a body fluid analyzer in fluid communication with the body fluid in the patient;

transporting a sample of the body fluid toward the body fluid analyzer;

with the body fluid analyzer, measuring a characteristic of an analyte in the bodily fluid and determining the concentration of the analyte in the body fluid, while the analyzer is in fluid communication with the body fluid in the patient; and

with a treatment dosing system in communication with the body fluid analyzer, determining a recommended dose for an infusion fluid based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and a treatment dosing protocol.

35. The method of claim 34, wherein the body fluid analyzer comprises a spectroscopic analyzer.

36. The method of claim 34, wherein the analyte comprises glucose and the infusion fluid comprises insulin.

37. The method of claim 36, wherein the treatment dosing system comprises a tight glycemic control protocol.

38. The method of claim 34, further comprising infusing the infusion fluid toward the patient at the recommended dose.

39. The method of claim 34, further comprising providing a user interface indicating information related to the recommended dose, an actual dose of the infusion fluid, or both.

40. The method of claim 39, further comprising adjusting, via the user interface, the actual dose of the infusion fluid.

41. The method of claim 34, wherein placing a body fluid analyzer in fluid communication with the body fluid in the patient further comprises:

providing a fluid transport network having a patient end; and

with the fluid transport network, establishing fluid communication with the body fluid in the patient through the patient end, the body fluid analyzer accessible via the fluid transport network; and

wherein transporting a sample of the body fluid toward the body fluid analyzer comprises drawing a sample of the body fluid from the patient end and toward the body fluid analyzer.

42. A method of monitoring and regulating the concentration of one or more analytes in a sample of bodily fluid, said method comprising:

providing a fluid connection to a patient;

periodically withdrawing a certain volume of bodily fluid from the patient at draw intervals of less than 1 hour;

sensing a property of the withdrawn fluid using one or more sensors;

dividing the withdrawn volume of fluid into an analysis portion and a return portion;

measuring a characteristic of said analysis portion to determine the concentration of an analyte in said analysis portion;

determining a recommended dose for an infusion fluid for an infusion fluid based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and a treatment dosing protocol; and

providing an instruction to an infusion fluid system to infuse the recommended dose of infusion fluid into the patient at a prescribed infusion fluid delivery rate.

44. The system of claim 42, wherein the graphic user interface includes an input element configured to accept user input, the user interface further configured to adjust the actual dose of the infusion fluid based at least in part on the user input.

45. The system of claim 44, wherein the graphic user interface is configured to display both the recommended dose and the actual dose, where both the recommended dose and the actual dose are expressed as infusion rates.

46. The system of claim 42, wherein the graphic user interface includes an input element configured to accept user input, the user interface configured to actuate the pump unit based at least in part on the user input.

43. An analyte detection and treatment dosing system comprising:

a fluid transport network configured to provide fluid communication with a body fluid in a patient;

a body fluid analyzer accessible via the fluid transport network, the body fluid analyzer configured to measure a characteristic of at least one analyte in the body fluid and determine the concentration of the at least one analyte from the measured characteristic;

a treatment dosing system in communication with the body fluid analyzer, said treatment dosing system including a treatment dosing protocol and configured to determine a recommended dose for an infusion fluid configured to provide glycemic control, wherein the recommended dose is determined based at least in part on one or more determinations by the body fluid analyzer of the concentration of the analyte and the treatment dosing protocol;

a treatment pump coupled to the fluid transport network, the treatment pump operable to transport the infusion fluid to the patient through the patient end; and

a fluid system controller comprising a graphic user interface, said fluid system controller configured to actuate the treatment pump and control the pump rate of the pump;

wherein the fluid system controller and the body fluid analyzer are both included within a single housing, the graphic user interface is located on the same housing, and the graphic user interface is configured to display the determined analyte concentration and the recommended dose.

47. An analyte monitoring system comprising:

a fluidic system in fluid communication with a source of bodily fluid, said fluidic system being configured to obtain a sample of bodily fluid from the source;

an analyte detection system configured to analyze the sample of bodily fluid or a component of the sample of bodily fluid; and

a fluid infusion system;

wherein the analyte detection system is configured to determine the concentration of an analyte in said sample of the bodily fluid or a component of the sample of the bodily fluid;

wherein the analyte detection system is configured to access a measurement database and calculate an average concentration of the analyte based on the determined concentration and one or more previous values for the concentration of the analyte stored in the measurement database.

48. The analyte monitoring system of claim 47, wherein the analyte detection system is further configured to determine a rate of change of the concentration of the analyte.

49. The analyte monitoring system of claim 47, wherein the analyte detection system determines a recommended treatment dose based on the average concentration of the analyte if the determined concentration is not within a prescribed range.

50. The analyte monitoring system of claim 49, wherein the analyte detection system communicates with the fluid infusion system to deliver the recommended treatment dose.

51. An analyte monitoring system comprising:

a fluidic system in fluid communication with a source of bodily fluid, said fluidic system being configured to obtain a first sample of bodily fluid from the source at a first time;

an analyte detection system configured to analyze the first sample of bodily fluid or a component of the first sample of bodily fluid; and

a fluid infusion system;

wherein the analyte detection system is configured to determine the concentration of an analyte in said first sample of the bodily fluid or a component of the first sample of the bodily fluid and store the value of the determined concentration in a measurement database,

wherein the fluidic system further obtains a second sample of the bodily fluid at a second time and presents said second sample to the analyte detection system for analysis,

wherein the analyte detection system analyzes the second sample or a component of the second sample and determines the concentration of the analyte in the second sample or the component of the second sample,

wherein the analyte detection system calculates a rate of change of the concentration of the analyte and determines a treatment dose based on the rate of change of the concentration of the analyte if the concentration of the analyte in the second sample is not within a prescribed range, and

wherein the analyte detection system communicates with the fluid infusion system to deliver the determined treatment dose.

52. An analyte monitoring system comprising:

a fluidic system in fluid communication with a source of bodily fluid, said fluidic system being configured to obtain a sample of bodily fluid from the source several times in a give time interval;

an analyte detection system configured to analyze the sample of bodily fluid or a component of the sample of bodily fluid and determine the concentration of an analyte in said sample of the bodily fluid or a component of the sample of the bodily fluid, wherein the analyte detection system is further configured to access a measurement history and store the estimated concentration of the analyte in the measurement history;

a feedback system; and

a user interface configured to accept an input from a user;

wherein the feedback system calculates a predicted value for the concentration of the analyte at a future time based on the input from the user and one or more previous values for the concentration of the analyte stored in the measurement history, and

wherein the feedback system alerts the user if the predicted value for the concentration is not within an acceptable range.

53. An analyte monitoring system comprising:

a fluidic system in fluid communication with a source of bodily fluid, said fluidic system being configured to obtain a sample of bodily fluid from the source several times in a give time interval;

an analyte detection system configured to analyze the sample of bodily fluid or a component of the sample of bodily fluid and determine the concentration of an analyte in said sample of the bodily fluid or a component of the sample of the bodily fluid, wherein the analyte detection system is further configured to access a measurement history and store the estimated concentration of the analyte in the measurement history;

a fluid infusion system comprising a plurality of infusion fluid sources, each infusion fluid source configured to provide one or more drugs or chemicals;

a user feedback system;

a watch list comprising a catalog of spectra related to various known substances that may present medical hazards, alone or in combination, the watch list being electronically accessible to the user feedback system; and

a user interface configured to provide information to a user and accept input from the user;

wherein the feedback system is configured to obtain one or more spectroscopic measurements of the contents of the plurality of infusion fluid sources, compare the spectroscopic measurements with the watch list, and alert the user through the user interface if any substance in the watch list is detected in the plurality of infusion fluid sources.

54. A combined glucose monitoring and adjustment system comprising:

a fluid control device with pumps, valves, and fluid passageways configured to draw fluid from a fluid source and deliver a portion of that fluid to an analyte monitoring system;

an optical glucose meter configured to irradiate the fluid or a portion thereof and detect secondary radiation, either transmitted or reflected, and determine, based on that secondary radiation, a concentration of an analyte in the fluid;

a glucose adjustment system comprising;

a repository of a treatment substance selected from the group consisting of insulin and a sugar;

a pump configured to adjust the level of glucose in the fluid source by infusing insulin and/or sugar; and

a controller configured to control the pump.

55. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than twice per day.

56. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than once per day.

57. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than once every 36 hours.

58. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than once every two days.

59. The analyte detection system of claim 54, wherein the body fluid analyzer is configured for calibration no more than once every three days.