Methods for use in assessing a flow condition of a fluid

• US 7,399,401 B2
• Filed: 04/13/2005
• Issued: 07/15/2008
• Est. Priority Date: 10/09/2002
• Status: Expired due to Fees

• Current Assignee: Therasense Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories)
• Inventors: Rush, Benjamin M.
• Primary Examiner(s): Olsen; Kaj K
• Application Number:
  US11/106,256
• Publication Number:
  US 20050249606A1
• Time in Patent Office: 1,189 Days
• Field of Search: 204/400, 204/403.01, 204/409, 204/411, 205/775, 205/789.5, 205/793.5, 738/610.7, 738/610.8, 600/504
• US Class Current: 205/789.5
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/0288 Electro-rheological or magneto-rheological materials
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 5/14216 Reciprocating piston type
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: F04B 2205/09 Flow through the pump
• CPC Class Codes: F04B 43/043 Micropumps
• CPC Class Codes: F04B 49/065 and making use of computers
• CPC Class Codes: F04B 51/00 Testing machines, pumps, or pumping installations
• CPC Class Codes: F05C 2251/08 Shape memory
• CPC Class Codes: G01F 1/64 by measuring electrical currents passing through the fluid flow; measuring electrical potential generated by the fluid flow, e.g. by electrochemical, contact or friction effects G01F1/58 takes precedence
• CPC Class Codes: G01F 1/708 Measuring the time taken to traverse a fixed distance
• CPC Class Codes: G01F 1/7088 using electrically charged particles as tracers
• CPC Class Codes: G01F 25/10 of flowmeters

Abstract

A device for use in assessing a flow condition of a fluid, or a fluid in a flow path, is provided. The device comprises at least one electrochemical cell, comprising a working electrode and at least one other electrode, sufficient for communication with the fluid, or sufficient for communication with a flow path, such that when sufficient fluid is in the flow path, the cell is in communication with the fluid. The fluid comprises a component sufficient to affect a mass-transport limited electrochemical reaction at the working electrode. The device also comprises at least one microcontroller operably connected to the at least one electrochemical cell for providing a potential or a current to the working electrode and for assessing the electrochemical reaction. A method of assessing a flow condition of a fluid, or a fluid in a flow path, is also provided. The device and the method of the present invention may be used in connection with the delivery of a fluid-borne or fluidized drug or medicament to a subject.

Claims

1. A method of assessing a flow condition of a fluid, comprising:

determining a time period associated with a delivery of a fluid, the fluid comprising a component to support an electrochemical reaction such that the electrochemical reaction is mass-transport limited;

monitoring a rate of electrochemical reaction in a fluid path of the fluid delivery for the determined time period; and

determining a rate of the fluid delivery based at least in part on the monitored rate of electrochemical reaction;

wherein the fluid comprises a drug and the component comprises a reactant in the electrochemical reaction that is dilute relative to the fluid, and the reactant is an ionic species.

2. The method of claim 1, wherein the fluid comprises a material selected from insulin, an antibiotic, a nutrient, a dietary supplement, a health supplement, total parental nutrition, an analgesic, an anesthetic, a pain reliever, a hormone, a hormonal drug, a gene therapy drug, an anticoagulant, a cardiovascular drug, AZT, a chemotherapeutic drug, any source thereof, or any combination thereof.

3. The method of claim 1, wherein the component is of a concentration of from about 10⁻

7M to about 10<sup>−

2</sup>M relative to the fluid.

4. The method of claim 1, wherein the fluid is insulin and the reactant is ionic zinc.

5. The method of claim 1, wherein the fluid delivery is provided in a continuous manner.

6. The method of claim 1, wherein the fluid delivery is provided in a non-continuous manner.

7. The method of claim 1, wherein the fluid delivery is provided in at least two pulses.

8. The method of claim 7, wherein the monitored rate of electrochemical reaction is associated with each of the at least two pulses.

9. The method of claim 7, wherein the monitored rate of electrochemical reaction is associated with the at least two pulses at a predetermined interval.

10. The method of claim 1, wherein monitored rate of electrochemical reaction includes a current, a potential, a charge, or any combination thereof.

11. The method of claim 1, further comprising calibrating the rate of the fluid delivery based at least in part on the monitored electrochemical reaction.

12. The method of claim 1, further comprising controlling the rate of the fluid delivery based at least in part on the monitored electrochemical reaction.

13. The method of claim 12, wherein the controlling is automated.

14. The method of claim 1, further comprising obtaining a temperature of the fluid.

15. The method of claim 14, further comprising controlling the rate of the fluid delivery based at least in part on the temperature.

16. The method of claim 15, wherein the controlling is automated.

17. The method of claim 1 wherein the component at least in part interferes with transport of the reactant.

18. A method of assessing a flow condition of a fluid, comprising:

determining a time period associated with a delivery of a fluid, the fluid comprising a component to support an electrochemical reaction such that the electrochemical reaction is mass-transport limited;

monitoring a rate of electrochemical reaction in a fluid path of the fluid delivery for the determined time period; and

determining a rate of the fluid delivery based at least in part on the monitored rate of electrochemical reaction;

wherein the fluid comprises a drug and the component comprises a reactant in the electrochemical reaction that is dilute relative to the fluid, and the drug is insulin and the reactant is ionic zinc.

19. The method of claim 18, wherein the component is of a concentration of from about 10⁻

7M to about 10<sup>−

2</sup>M relative to the fluid.

20. The method of claim 18, wherein the fluid delivery is provided in a continuous manner.

21. The method of claim 18, wherein the fluid delivery is provided in a non-continuous manner.

22. The method of claim 18, wherein the fluid delivery is provided in at least two pulses.

23. The method of claim 22, wherein the monitored rate of electrochemical reaction is associated with each of the at least two pulses.

24. The method of claim 22, wherein the monitored rate of electrochemical reaction is associated with the at least two pulses at a predetermined interval.

25. The method of claim 18, wherein monitored rate of electrochemical reaction includes a current, a potential, a charge, or any combination thereof.

26. The method of claim 18, further comprising calibrating the rate of the fluid delivery based at least in part on the monitored electrochemical reaction.

27. The method of claim 18, comprising controlling the rate of the fluid delivery based at least in part on the monitored electrochemical reaction.

28. The method of claim 27, wherein the controlling is automated.

29. The method of claim 18, comprising obtaining a temperature of the fluid.

30. The method of claim 29, comprising controlling the rate of the fluid delivery based at least in part on the temperature.

31. The method of claim 30, wherein the controlling is automated.

32. A method of assessing a flow condition of a fluid, comprising:

determining a time period associated with a delivery of a fluid, the fluid comprising a component to support an electrochemical reaction such that the electrochemical reaction is mass-transport limited;

monitoring a rate of electrochemical reaction in a fluid path of the fluid delivery for the determined time period; and

determining a rate of the fluid delivery based at least in part on the monitored rate of electrochemical reaction;

wherein the fluid comprises a reactant in the electrochemical reaction and the component at least in part interferes with transport of the reactant, and the fluid comprises a drug and the reactant is an ionic species.

33. The method of claim 32, wherein the fluid comprises a material selected from insulin, an antibiotic, a nutrient, a dietary supplement, a health supplement, total parental nutrition, an analgesic, an anesthetic, a pain reliever, a hormone, a hormonal drug, a gene therapy drug, an anticoagulant, a cardiovascular drug, AZT, a chemotherapeutic drug, any source thereof, or any combination thereof.

34. The method of claim 32, wherein the component is of a concentration of from about 10⁻

7M to about 10<sup>−

2</sup>M relative to the fluid.

35. The method of claim 32, wherein the fluid is insulin.

36. The method of claim 32, wherein the drug is insulin and the reactant is ionic zinc.

37. The method of claim 32, wherein the fluid delivery is provided in a continuous manner.

38. The method of claim 32, wherein the fluid delivery is provided in a non-continuous manner.

39. The method of claim 32, wherein the fluid delivery is provided in at least two pulses.

40. The method of claim 39, wherein the monitored rate of electrochemical reaction is associated with each of the at least two pulses.

41. The method of claim 39, wherein the monitored rate of electrochemical reaction is associated with the at least two pulses at a predetermined interval.

42. The method of claim 32, wherein monitored rate of electrochemical reaction includes a current, a potential, a charge, or any combination thereof.

43. The method of claim 32, comprising calibrating the rate of the fluid delivery based at least in part on the monitored electrochemical reaction.

44. The method of claim 32, comprising controlling the rate of the fluid delivery based at least in part on the monitored electrochemical reaction.

45. The method of claim 44, wherein the controlling is automated.

46. The method of claim 32, comprising obtaining a temperature of the fluid.

47. The method of claim 46, comprising controlling the rate of the fluid delivery based at least in part on the temperature.

48. The method of claim 47, wherein the controlling is automated.

49. The method of claim 32 wherein the component is dilute relative to the fluid.

50. A method of assessing a flow condition of a fluid, comprising:

determining a time period associated with a delivery of a fluid, the fluid comprising a component to support an electrochemical reaction such that the electrochemical reaction is mass-transport limited;

monitoring a rate of electrochemical reaction in a fluid path of the fluid delivery for the determined time period; and

determining a rate of the fluid delivery based at least in part on the monitored rate of electrochemical reaction;

wherein the fluid comprises a reactant in the electrochemical reaction and the component at least in part interferes with transport of the reactant, and the fluid comprises insulin and the reactant is ionic zinc.

51. The method of claim 50 wherein the component is dilute relative to the fluid.

52. The method of claim 50, wherein the component is of a concentration of from about 10⁻

7M to about 10<sup>−

2</sup>M relative to the fluid.

53. The method of claim 50, wherein the fluid delivery is provided in a continuous manner.

54. The method of claim 50, wherein the fluid delivery is provided in a non-continuous manner.

55. The method of claim 50, wherein the fluid delivery is provided in at least two pulses.

56. The method of claim 55, wherein the monitored rate of electrochemical reaction is associated with each of the at least two pulses.

57. The method of claim 55, wherein the monitored rate of electrochemical reaction is associated with the at least two pulses at a predetermined interval.

58. The method of claim 50, wherein monitored rate of electrochemical reaction includes a current, a potential, a charge, or any combination thereof.

59. The method of claim 50, comprising calibrating the rate of the fluid delivery based at least in part on the monitored electrochemical reaction.

60. The method of claim 50, comprising controlling the rate of the fluid delivery based at least in part on the monitored electrochemical reaction.

61. The method of claim 60, wherein the controlling is automated.

62. The method of claim 50, comprising obtaining a temperature of the fluid.

63. The method of claim 62, comprising controlling the rate of the fluid delivery based at least in part on the temperature.

64. The method of claim 63, wherein the controlling is automated.