Blood glucose level control

• US 8,700,161 B2
• Filed: 09/04/2003
• Issued: 04/15/2014
• Est. Priority Date: 03/05/1999
• Status: Expired due to Fees

• Current Assignee: Tylerton International Inc.
• Original Assignee: MetaCure Limited (MetaCure (USA), Inc.)
• Inventors: Harel, Tami, Policker, Shai, Khawaled, Radwan, Mika, Yuval, Glasberg, Offer, Grossman, Aharon
• Primary Examiner(s): PATTON, AMANDA K
• Application Number:
  US10/526,708
• Publication Number:
  US 20060085045A1
• Time in Patent Office: 3,876 Days
• Field of Search: 600/347, 600/365, 604/504, 607/40, 607/133, 607/2, 607/62
• US Class Current: 607/40
• CPC Class Codes: A61N 1/0507 Electrodes for the digestive system
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36121 Production of neurotransmitters; Modulation of genes expression
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters

Abstract

A method of glucose level control, comprising providing at least one electrode adapted to apply an electric field to a pancreas; and applying an electric field to the pancreas using the above-mentioned at least one electrode such that blood glucose levels are significantly reduced and blood insulin levels are not significantly increased.

Claims

1. A method of glucose level control, comprising:

providing at least one implanted electrode for applying an electric field to affect a pancreas; and

reducing blood glucose levels by at least 10%, by applying an electric field to affect the pancreas using said at least one implanted electrode, while not increasing blood insulin levels by more than 20%.

2. A method according to claim 1, comprising subsequently applying a second electric field to affect said pancreas, which second field increases insulin levels.

3. A method according to claim 1, wherein said electric field is operative to reduce glucagon secretion.

4. A method according to claim 1, wherein said electric field is operative to reduce glucose secretion by a liver physiologically coupled to said pancreas.

5. A method according to claim 1, wherein said electric field is operative to increase glucose uptake by cells in a body containing said pancreas.

6. A method according to claim 1, wherein said electric field is operative to affect nervous tissue in said pancreas.

7. A method according to claim 1, wherein said electric field is non-excitatory in that it does not substantially induce new bursts of islet activity in said pancreas.

8. A method according to claim 1, wherein said electric field is applied as a bi-phasic and charge balanced time varying field.

9. A method according to claim 8, wherein said electric field is applied for a short duration every period of time.

10. A method according to claim 9, wherein said period of time gives an application frequency of between 1 Hz and 15 Hz.

11. A method according to claim 9, wherein said period of time gives an application frequency of about 5 Hz.

12. A method according to claim 9, wherein said duration is less than 30 ms.

13. A method according to claim 9, wherein said duration is about 10 ms.

14. A method according to claim 1, wherein said electric field is repeated for a period of less than 30 minutes.

15. A method according to claim 1, wherein said electric field is repeated for a period of between 30 and 180 minutes.

16. A method according to claim 1, wherein said electric field is applied for substantially all of a duration of a glucose absorption event.

17. A method according to claim 1, wherein said electric field is applied prior to an expected ingestion event.

18. A method according to claim 1, comprising triggering said electric field by a ingestion event.

19. A method according to claim 1, wherein said electric field is applied irrespectively of an ingestion event.

20. A method according to claim 1, wherein said electric field is applied at least part of the time irrespective of a blood glucose level.

21. A method according to claim 1, wherein said electric field is applied continuously for at least 24 hours.

22. A method according to claim 1, wherein said electric field is applied for a period of at least 15 minutes without sensing of its effect.

23. A method according to claim 1, wherein said electric field is of a magnitude and temporal extent so that it does not significantly change blood insulin and glucose levels in the absence of an ingestion event.

24. A method according to claim 1, wherein said electric field reduces blood glucose levels by at least 20% of an elevation of the glucose level above a fasting baseline glucose level.

25. A method according to claim 1, wherein said electric field does not increase blood insulin levels, as measured by an average over five minutes, by more than 20%.

26. A method according to claim 1, comprising, delaying a gastric emptying by applying a treatment to the stomach.

27. A method according to claim 1, wherein said electric field is operative to delay a glucose peak at least by a duration of its application.

28. A method according to claim 1, wherein said electric field is operative to delay a glucose peak at least by 10 minutes.

29. A method according to claim 1, wherein said electric field is operative to delay an insulin peak at least by 10 minutes.

30. A method according to claim 1, wherein said applying does not elevate insulin levels by more than 10%.

31. A method of glucose level control, comprising:

providing at least one implanted electrode adapted to apply an electric field to affect a pancreas; and

reducing blood glucose levels, only if elevated, by applying an electric field to affect the pancreas, using an electric field which does not reduce such levels by more than 20% if not elevated.

32. A method according to claim 31, wherein said electric field reduces elevated glucose levels by at least 20%.

33. A method according to claim 31, wherein said electric field does not reduce unelevated glucose levels by more than 10%.

34. A method according to claim 31, wherein said electric field does not impair exocrine functions of said pancreas.

35. Apparatus for blood glucose control, comprising:

at least one implanted electrode for applying an electric field to affect a pancreas, said electrode being clinically acceptable for human implantation;

circuitry for electrifying said at least one implantable electrode in a manner which compensates for a loss of acute response to a glucose ingestion event by said pancreas, wherein said circuitry reduces insulin secretion or avoids an increase in insulin secretion of more than 30% during said compensation; and

an implantable lead to which said electrode is electrically coupled.

36. Apparatus according to claim 35, wherein said circuitry compensates by causing the secretion of an insulin bolus.

37. Apparatus according to claim 35, wherein said circuitry compensates by reducing glucose levels in a non-insulin manner.

38. Apparatus according to claim 37, wherein said circuitry compensates by reducing glucagon secretion.

39. Apparatus according to claim 35, wherein for at least 20% of ingestion events said circuitry applies only an acute control of insulin levels.

40. Apparatus according to claim 39, wherein said apparatus is programmed with a knowledge of a slow acting chemical-based insulin therapy provided to said pancreas.

41. Apparatus according to claim 35, comprising an automatic ingestion sensor for automatically detecting an ingestion event.

42. Apparatus according to claim 35, comprising an automatic glucose sensor for automatically detecting a situation requiring an acute response.

43. Apparatus according to claim 35, comprising an automatic glucose sensor for automatically detecting a situation requiring an acute insulin response.

44. Apparatus according to claim 35, wherein said response is an acute insulin response.

45. Apparatus for blood glucose control, comprising:

at least one implantable electrode adapted to apply an electric field to affect pancreatic tissue; and

circuitry adapted to electrify said at least one implantable electrode in a manner which reduces glucose levels and does not elevate insulin levels more than 20% above a baseline value, when glucose levels are elevated.

46. Apparatus according to claim 45, wherein said circuitry is a closed loop system including sensing of the effect of the electrification and wherein said circuitry is configured to over stimulate in cases of doubt.

47. Apparatus according to claim 45, wherein said circuitry is a semi-open loop system where a relatively long stimulation series is applied without feedback.

48. Apparatus according to claim 45, wherein said circuitry is an open loop system where a stimulation series is applied responsive to a trigger and without feedback.

49. Apparatus according to claim 45, wherein said circuitry applies a constant voltage field.

50. Apparatus according to claim 45, wherein said circuitry applies a constant current field.

51. Apparatus according to claim 45, wherein said pancreatic tissue comprises an in-vivo pancreas.

52. Apparatus according to claim 45, wherein said pancreatic tissue comprises a pancreatic tissue implant.

53. A method of controlling blood glucose, the method comprising:

providing at least one implanted electrode located in a muscle and at least one second implanted electrode;

providing a fixed protocol; and

generating an electric field between said implanted electrodes to affect a pancreas in accordance with said fixed protocol,

wherein said generating comprises generating irrespective of blood glucose level, including both when blood glucose levels are elevated and when blood glucose levels are not elevated.

54. A method according to claim 53, wherein said fixed protocol comprises generating said electric field as a pulse series without synchronizing said pulse series to pancreatic activity.

55. A method according to claim 53, wherein said fixed protocol comprises generating said electric field as a pulse series irrespectively of an ingestion event.

56. A method according to claim 53, wherein pancreatic electrical activity is not measured during generating.

57. A method according to claim 53, wherein said fixed protocol comprises periodic application of a pulse series.

58. A method according to claim 53, wherein said electric field is repeated for a period of less than 30 minutes.

59. A method according to claim 53, wherein said electric field is repeated for a period of between 30 and 180 minutes.

60. A method according to claim 53, wherein said affecting a pancreas comprises indirectly affecting a pancreas via a different organ.