System and method for initiating and maintaining continuous, long-term control of a concentration of a substance in a patient using a feedback or model-based controller coupled to a single-needle or multi-needle intradermal (ID) delivery device

• US 7,060,059 B2
• Filed: 10/14/2003
• Issued: 06/13/2006
• Est. Priority Date: 10/11/2002
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Parker, Robert S., Pettis, Ronald J., DeNuzzio, John D., Keith, Steven, Vonk, Glenn, Harvey, Noel G.
• Primary Examiner(s): Kennedy, Sharon
• APPLICATION: US 20040152622A1
• Time in patent office: 973 Days
• Field of Search: 604/27, 604/31, 604 65- 67, 604/503, 604/504, 604/890.1, 604/506, 604/272
• US Class Current: 604/504
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A closed loop therapy system for controlling a concentration of a substance, such as blood glucose concentration, in the body of a user. The system and method employ a sensor system that measures a glucose level in the body, a controller that uses the measured glucose levels to generate an output that can be used to automatically or manually control an intradermal insulin infusion system to set a constant or time-varying profile of target blood glucose concentrations in a user, and then infuse an appropriate amount of insulin into the body of the user so as to reach and maintain the target values of the blood glucose concentration.

Claims

1. A system for controlling the concentration of a substance in a patient, the system comprising:

a delivery device comprising at least one needle configured with a length sufficient to deliver a material to the intradermal compartment of said patient to result in at least one of rapid uptake of said material and rapid clearance of said material; and

a controller, adapted to determine the concentration of said substance in the patient that occurs in response to said material delivered to the patient, and to provide an output that is adaptable for use to control the delivery device to control an amount of said material delivered to the patient based on the concentration of said substance.

2. The system of claim 1, wherein:

said controller is adapted to provide said output to said delivery device to automatically control the delivery device.

3. The system of claim 1, wherein:

said controller provides said output as information relating to the concentration of said substance which is readable for use in manual adjustment of said delivery device to infuse the appropriate amount of material into the patient.

4. The system of claim 1, wherein:

said material includes insulin and said substance includes glucose.

5. The system of claim 4, wherein:

said insulin includes short-acting insulin.

6. The system of claim 1, wherein:

said material and said substance are the same.

7. The system of claim 1, wherein:

said delivery device comprises a single-needle array or a multi-needle array, adapted to deliver said material to the patient intradermally.

8. The system of claim 1, further comprising:

a sensor, adapted to detect said concentration of said substance in the patient and to provide a signal indicative thereof to said controller, which is adapted to analyze said signal to determine the concentration of said substance in the patient.

9. The system of claim 8, wherein:

said sensor is adapted to detect said concentration of said substance at a location in said patient, and said controller is adapted to analyze said signal to estimate said concentration of said substance at another location in the patient different from said location at which said sensor detected said concentration.

10. The system of claim 1, further comprising:

a self-contained power source adapted to power said system.

11. The system of claim 1, further comprising:

an insulin storage device, adapted to store insulin as said material for delivery to said patient.

12. The system of claim 1, wherein said system is portable and wearable by the patient.

13. The system of claim 1, wherein at least a portion of communications between said controller and said delivery device includes wireless communications.

14. The system of claim 8, wherein at least a portion of communications between said controller, said sensor and said delivery device includes wireless communications.

15. The system of claim 1, wherein said controller is adapted to communicate with a device outside of the system to relay information between the controller and at least one of the patient and a health care provider.

16. The system of claim 1, wherein said controller employs a control model that includes a physiologically based model.

17. The system of claim 1, wherein said controller employs a control model that includes a data based empirical model.

18. The system of claim 1, wherein:

said material includes insulin and said substance includes glucose; and

said controller employs an algorithm to compare a pre-delivery concentration of said glucose present prior to said delivery of said insulin to a target or predicted glucose concentration, to compare a post-delivery concentration of said glucose present after said delivery of said insulin to a target or predicted glucose concentration, and to determine an appropriate insulin dose based on these comparisons.

19. The system of claim 18, wherein:

said controller employs a control model that includes a physiologically based model, and said controller adjusts said model based on the comparison of said post-delivery glucose concentration and said target or predicted glucose concentration.

20. The system of claim 18, wherein:

said controller employs a control model that includes a data based (empirical) model, and said said controller adjusts said model based on the comparison of said post-delivery glucose concentration and said target or predicted glucose concentration.

21. The system of claim 1, wherein:

said controller is adapted to provide an output that is adapted for use to control the delivery device to control an amount of said material delivered to the patient based on;

the concentration of said substance, and

an analysis of the patient'"'"'s PK/PD (pharmacokinetics and pharmacodynamics) response to said material.

22. A method for controlling the concentration of a substance in a patient, the method comprising:

delivering a material to the patient intradermally to result in at lease one of rapid uptake of said material and rapid clearance of said material; and

determining the concentration of said substance in the patient that occurs in response to said material delivered to the patient; and

providing an output that is adaptable for use to control an amount of said material delivered to the patient based on the concentration of said substance.

23. The method of claim 22, wherein:

said providing provides said output to a delivery device to automatically control the delivery device to control said amount of said material delivered to the patient.

24. The method of claim 22, wherein:

said providing provides said output as information relating to the concentration of said substance which is readable for use in manual adjustment of a delivery device to infuse the appropriate amount of said material into the patient.

25. The method of claim 22, wherein:

said material includes insulin and said substance includes glucose.

26. The method of claim 25, wherein:

said insulin includes short-acting insulin.

27. The method of claim 22, wherein:

said material and said substance are the same.

28. The method of claim 22, wherein:

said delivering step includes operating a delivery device comprising a single-needle or a multi-needle array to deliver said material to the patient intradermally.

29. The method of claim 22, further comprising:

sensing said concentration of said substance in the patient and to provide a signal indicative thereof which is used in said determining step to analyze said signal to determine the concentration of said substance in the patient.

30. The method of claim 29, wherein:

said sensing senses said concentration of said substance at a location in said patient, and said determining analyzes said signal to estimate said concentration of said substance at another location in the patient different from said location at which said sensing detected said concentration.

31. The method of claim 22, further comprising:

providing power to a system that is adapted to perform said delivering, determining and providing steps using a self-contained power source.

32. The method of claim 22, further comprising:

storing insulin as said material for delivery to said patient.

33. The method of claim 22, wherein:

said delivering, determining and providing steps are performed by a system that is portable and wearable by the patient.

34. The method of claim 22, further comprising:

communicating wirelessly between a delivery device that performs said delivering step and a controller that performs said determining and providing steps.

35. The method of claim 22, further comprising:

communicating wirelessly between a delivery device that performs said delivering step, a controller that performs said determining and providing steps and a sensor that performs said sensing step.

36. The method of claim 22, further comprising:

communicating with a device outside of the system that performs said delivering, determining and providing steps to relay information between the system and at least one of the patient and a health care provider.

37. The method of claim 22, wherein said determining step employs a control model that includes a physiologically based model.

38. The method of claim 22, wherein:

said material includes insulin and said substance includes glucose; and

said determining step employs an algorithm to compare a pre-delivery concentration of said glucose present prior to said delivery of said insulin to a target or predicted glucose concentration, to compare a post-delivery concentration of said glucose present after said delivery of said insulin to a target or predicted glucose concentration, and to determine an appropriate insulin dose based on these comparisons.

39. The method of claim 38, wherein:

said determining step employs a control model that includes a physiologically based model, and said controller adjusts said model based on the comparison of said post-delivery glucose concentration and said target or predicted glucose concentration.

40. The method of claim 38, wherein:

said determining step employs a control model that includes a data based (empirical) model, and said controller adjusts said model based on the comparison of said post-delivery glucose concentration and said target or predicted glucose concentration.

41. The method of claim 22, wherein:

said rapid uptake is influenced by a PK/PD (pharmacokinetics and pharmacodynamics) effect on said material.

42. A system for adjusting the concentration of a substance in a patient, the system comprising:

a controller, adapted to provide information representing a profile of target concentrations; and

a delivery device, adapted to deliver a material to the patient intradermally under the control of the controller to adjust the concentration of the substance to the target concentration substantially in accordance with the profile.

43. A system as claimed in claim 42, wherein:

the substance is blood glucose and the material includes insulin.

44. A system as claimed in claim 42, wherein:

the profile includes a plurality of target concentrations over time.

45. A system as claimed in claim 42, wherein:

the profile is representable as a line having a non-zero slope.

46. A system as claimed in claim 42, wherein:

the delivery device includes a single-needle or a multi-needle array.

47. A method for adjusting the concentration of a substance in a patient, the method comprising:

providing information representing a profile of target concentrations; and

delivering a material to the patient intradermally under the control of the controller to adjust the concentration of the substance to the target concentration substantially in accordance with the profile.

48. A method as claimed in claim 47, wherein:

the substance is blood glucose and the material includes insulin.

49. A method as claimed in claim 47, wherein:

the profile includes a plurality of target concentrations over time.

50. A method as claimed in claim 47, wherein:

the profile is representable as a line having a non-zero slope.

51. A method as claimed in claim 47, wherein:

the delivering step includes using a delivery device having a single-needle or a multi-needle array to deliver the material.