Gastrointestinal methods and apparatus for use in treating disorders and controlling blood sugar

• US 8,792,985 B2
• Filed: 01/20/2006
• Issued: 07/29/2014
• Est. Priority Date: 07/21/2003
• Status: Expired due to Fees

• Current Assignee: Tylerton International Inc.
• Original Assignee: MetaCure Limited (MetaCure (USA), Inc.)
• Inventors: Ben-Haim, Shlomo, Harel, Tamar, Policker, Shao, Biton, Ofir
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US11/336,099
• Publication Number:
  US 20070027493A1
• Time in Patent Office: 3,112 Days
• Field of Search: 607/40, 607/41, 607/133
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A method and apparatus are provided for treating a subject. An electrical signal is applied to at least one stomach site of the subject. The electrical signal is configured to reduce a rise in a blood glucose level of the subject, in order to treat the subject.

Claims

1. Apparatus for treating a subject, comprising:

a set of one or more electrodes, adapted to be applied to respective sites of a stomach of the subject; and

a control unit, adapted to drive the electrode set to apply to the respective sites of the stomach, as a train of biphasic pulses, an electrical signal configured to reduce a blood glucose level of the subject compared to the blood glucose level if the electrical signal were not applied, if the subject were to consume a same quantity of glucose with and without application of the electrical signal.

2. The apparatus according to claim 1, wherein the control unit is adapted to drive the electrode set to apply an Excitable-Tissue Control (ETC) signal.

3. The apparatus according to claim 1, wherein the control unit is adapted to drive the electrode set to apply the electrical signal in pulses in a pulse train, and to configure a length of the pulse train to be between 1 and 6 seconds.

4. The apparatus according to claim 3, wherein the control unit is adapted to configure the length of the pulse train to be between 3 and 6 seconds.

5. The apparatus according to claim 1, wherein the control unit is adapted to detect physiological parameters of the subject and drive the electrode set to apply the electrical signal responsive thereto.

6. The apparatus according to claim 5, wherein the physiological parameters are indicative of ingestion by the subject.

7. The apparatus according to claim 5, further comprising a set of one or more sensors, configured to be placed on or in a gastrointestinal tract of the subject, and to detect the physiological parameters.

8. The apparatus according to claim 7, wherein the control unit is adapted to detect a slow wave of the stomach.

9. The apparatus according to claim 1, wherein the control unit is configured to detect eating by the subject, and to apply the electrical signal responsive to detecting the eating.

10. The apparatus according to claim 1, wherein the electrodes are configured to be applied to the respective stomach sites in a vicinity of a pylorus of the subject.

11. The apparatus according to claim 1, wherein the electrodes are configured to be applied to an antrum of the stomach.

12. The apparatus according to claim 1, wherein the control unit is adapted to drive the electrode set to apply the electrical signal to the respective sites of the stomach, following detection of onset of each slow wave of the stomach.

13. The apparatus according to claim 1, wherein the control unit is adapted to drive the electrode set to apply the electrical signal in pulses and to configure a pulse amplitude of the pulses to be between 3 to 12 mA.

14. The apparatus according to claim 1, wherein the control unit is adapted to set a duration of each phase of the biphasic pulses to be between 3 and 10 ms.

15. The apparatus according to claim 1, wherein the control unit is adapted to drive the electrode set to apply five or more pulses to the site during each of a plurality of slow wave cycles of the stomach.

16. The apparatus according to claim 1, wherein the one or more electrodes are adapted to be inserted into the muscular layer of the stomach.

17. The apparatus according to claim 1, wherein the control unit is adapted to configure the electrical signal to reduce the blood glucose level throughout a period of time that includes a point in time at approximately 7 minutes after commencement of application of the electrical signal.

18. Apparatus for treating a subject, comprising:

a set of electrodes that comprises at least a first electrode, adapted to be implanted at a gastric corpus site, and at least a second electrode, adapted to be implanted at a gastric antrum site; and

a control unit, configured to drive, between the at least a first electrode at the gastric corpus site and the at least a second electrode at the gastric antrum site, an electrical signal configured to reduce a rise in a blood glucose level of the subject.

19. The apparatus according to claim 18, wherein the at least at least a first electrode and the at least a second electrode are adapted to be inserted into the muscular layer of the stomach.

20. The apparatus according to claim 18, wherein the control unit is adapted to configure the electrical signal to reduce the rise in the blood glucose level throughout a period of time that includes a point in time at approximately 7 minutes after commencement of application of the electrical signal.

21. Apparatus for treating a subject, comprising:

a set of at least one electrode, adapted to be applied to a respective at least one stomach site of the subject; and

a control unit, adapted to drive the electrode set to apply, to the respective at least one stomach site, an electrical signal configured to reduce a rise in a blood glucose level of the subject,

wherein the control unit is adapted to drive the electrode set to apply the electrical signal as a train of biphasic pulses, and

wherein the control unit is adapted to set a duration of each phase of the biphasic pulses to be between 3 and 10 ms.

22. The apparatus according to claim 21, wherein the electrode set comprises a first electrode, adapted to be implanted at a first gastric corpus site, and a second electrode, adapted to be implanted at a second gastric corpus site.

23. The apparatus according to claim 21, wherein the control unit is adapted to configure the electrical signal to reduce a rise in a blood insulin level of the subject.

24. The apparatus according to claim 21, wherein the control unit is adapted to drive the electrode set to apply five or more pulses to the site during each of a plurality of slow wave cycles of the stomach.

25. The apparatus according to claim 21, wherein the control unit is adapted to drive the electrode set to apply 1 to 5 pulses to the site during each of a plurality of slow wave cycles of the stomach.

26. The apparatus according to claim 25, wherein the control unit is adapted to drive the electrode set to apply one pulse to the site during each of the plurality of slow wave cycles.

27. The apparatus according to claim 21, wherein the control unit is adapted to configure a frequency of the electrical signal to be between 1 and 30 Hz.

28. The apparatus according to claim 27, wherein the control unit is adapted to configure the frequency to be between 10 and 30 Hz.

29. The apparatus according to claim 27, wherein the control unit is adapted to configure the frequency to be between 1 and 10 Hz.

30. The apparatus according to claim 29, wherein the control unit is adapted to configure the frequency to be between 2.5 and 7.5 Hz.

31. The apparatus according to claim 21, wherein the control unit is adapted to configure a frequency of the electrical signal to be between 30 and 200 Hz.

32. The apparatus according to claim 31, wherein the control unit is adapted to configure the frequency to be between 100 and 200 Hz.

33. The apparatus according to claim 31, wherein the control unit is adapted to configure the frequency to be between 30 and 100 Hz.

34. The apparatus according to claim 33, wherein the control unit is adapted to configure the frequency to be between 60 and 100 Hz.

35. The apparatus according to claim 21, wherein the control unit is adapted to drive the electrode set to apply the electrical signal in pulses and to configure a pulse amplitude of the pulses to be between 2 and 15 mA.

36. The apparatus according to claim 35, wherein the control unit is adapted to configure the pulse amplitude to be between 2.5 and 7.5 mA.

37. The apparatus according to claim 21, wherein the control unit is adapted to set the duration of each phase of the biphasic pulses to be between 4 and 6 ms.

38. The apparatus according to claim 21, wherein to drive the electrode set to apply the electrical signal, the control unit is adapted to:

drive the electrode set to apply an initiating pulse; and

drive the electrode set to apply a burst of pulses at least 100 ms following a termination of the initiating pulse.

39. The apparatus according to claim 38, wherein the control unit is adapted to drive the electrode set to apply the initiating pulse not responsively to any physiological attribute of the subject sensed within one minute prior to the applying of the initiating pulse.

40. The apparatus according to claim 38, wherein the control unit is adapted to drive the electrode set to apply the initiating pulse not responsively to any sensing of a slow wave within one minute prior to the applying of the initiating pulse.

41. The apparatus according to claim 38, wherein the control unit is adapted to configure a frequency of the burst of pulses to be between 1 and 10 Hz.

42. The apparatus according to claim 38, wherein the control unit is adapted to configure a frequency of the burst of pulses to be between 10 and 100 Hz.

43. The apparatus according to claim 38, wherein the control unit is adapted to detect a physiological attribute of the subject and drive the electrode set to apply the initiating pulse response thereto.

44. The apparatus according to claim 43, wherein to detect the physiological attribute, the control unit is adapted to detect a gastrointestinal tract attribute of the subject.

45. The apparatus according to claim 44, wherein to detect the gastrointestinal tract attribute, the control unit is adapted to detect an indication of a slow wave of the stomach.

46. The apparatus according to claim 44, wherein to detect the gastrointestinal tract attribute, the control unit is adapted to detect an indication of eating by the subject.

47. The apparatus according to claim 38, wherein the control unit is adapted to drive the electrode set to initiate applying the burst of pulses less than 4 seconds following the termination of the initiating pulse.

48. The apparatus according to claim 47, wherein the control unit is adapted to drive the electrode set to initiate applying the burst of pulses between 100 and 500 ms following the termination of the initiating pulse.

49. The apparatus according to claim 38, wherein the control unit is adapted to configure a duration of the initiating pulse to be between 50 and 500 ms.

50. The apparatus according to claim 49, wherein the control unit is adapted to configure the duration to be between 50 and 150 ms.

51. The apparatus according to claim 21, wherein the control unit is adapted to drive the electrode set to apply an Excitable-Tissue Control (ETC) signal.

52. The apparatus according to claim 21, wherein the at least one electrode is adapted to be inserted into the muscular layer of a stomach of the subject.

53. The apparatus according to claim 21, wherein the control unit is adapted to configure the electrical signal to reduce the rise in the blood glucose level throughout a period of time that includes a point in time at approximately 7 minutes after commencement of application of the electrical signal.