GI and pancreatic device for treating obesity and diabetes

• US 8,095,218 B2
• Filed: 07/13/2006
• Issued: 01/10/2012
• Est. Priority Date: 07/13/2005
• Status: Expired due to Fees

• Current Assignee: Betastim, Ltd.
• Original Assignee: Betastim, Ltd.
• Inventors: Gross, Yossi, Benarie, Jacob, Khawaled, Radwan, Alon, Ruth
• Primary Examiner(s): Getzow, Scott
• Assistant Examiner(s): Dietrich, Joseph
• Application Number:
  US11/995,663
• Publication Number:
  US 20090062881A1
• Time in Patent Office: 2,007 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 is provided, including placing first and second electrodes (90) at respective first and second sites of a duodenum (40) of a subject, and activating the electrodes (90) to increase a blood insulin level of the subject. Other embodiments are also described.

Claims

1. An apparatus comprising:

one or more electrodes, adapted to be placed in contact with a wall of a duodenum of a subject; and

a control unit, adapted to;

drive the electrodes to apply a current to the wall of the duodenum,

configure the current to stimulate a site selected from the group consisting of;

a vagus nerve of the subject, and enteric nervous system (ENS) tissue of the subject,

configure the current in accordance with a set of parameters for the current, the set of parameters including a pulse width of pulses of the current and a frequency of application of the pulses, and

select the set of parameters to be such as to lower a level of glucose in blood of the subject and to be sufficient to cause closure of a pylorus of the subject.

2. The apparatus according to claim 1, wherein the site includes the vagus nerve of the subject, and wherein the control unit is adapted to configure the current to stimulate the vagus nerve.

3. The apparatus according to claim 1, wherein the site includes the ENS tissue of the subject, and wherein the control unit is adapted to configure the current to stimulate the ENS tissue.

4. The apparatus according to claim 1, comprising an eating sensor, and wherein the control unit is adapted to drive the electrodes to apply the current responsively to a signal from the eating sensor indicative of eating by the subject.

5. The apparatus according to claim 1, wherein the control unit is adapted to select the set of parameters to be such as to increase a level of insulin in blood of the subject.

6. The apparatus according to claim 1, wherein two of the one or more electrodes are adapted such that the two of the one or more electrodes, when in contact with the wall, are mutually spaced by a distance that is greater than the spacing between any other two of the one or more electrodes, when in contact with the wall, and wherein the distance is less than 3 cm.

7. The apparatus according to claim 1, wherein the control unit is adapted to (a) configure the current to include a plurality of pulses, and (b) set a frequency of application of the pulses to be at least 0.1 Hz.

8. The apparatus according to claim 7, wherein the control unit is adapted to set the frequency to be at least 1 Hz.

9. The apparatus according to claim 8, wherein the control unit is adapted to set the frequency to be at least 3 Hz.

10. The apparatus according to claim 1, wherein the control unit is adapted to configure the current to include a plurality of pulses, and wherein at least two consecutive ones of the pulses each have respective pulse widths that are less than 75 ms.

11. The apparatus according to claim 10, wherein the control unit is adapted to configure the pulse widths to be less than 30 ms.

12. The apparatus according to claim 11, wherein the control unit is adapted to configure the pulse widths to be less than 15 ms.

13. The apparatus according to claim 1, wherein the control unit is adapted to (a) configure the current to include a plurality of pulses, (b) set a frequency of application of the pulses to a desired frequency value, and (c) set pulse widths of at least two consecutive pulses to be less than a threshold pulse width, wherein a ratio of the threshold pulse width to the desired frequency value is less than 1000 ms/Hz.

14. The apparatus according to claim 13, wherein the ratio is less than 100 ms/Hz.

15. The apparatus according to claim 14, wherein the ratio is less than 10 ms/Hz.

16. The apparatus according to claim 1, wherein the control unit is adapted to configure the current to be sufficient to cause the closure of the pylorus via a nerve-mediated pathway, but to be insufficient to cause the closure of the pylorus via direct electrical stimulation of muscle tissue of the pylorus.

17. The apparatus according to claim 1, wherein the one or more electrodes comprise at least two electrodes adapted to be placed 2-5 cm from the pylorus.

18. The apparatus according to claim 1, wherein the one or more electrodes comprise at least two electrodes adapted to be placed 1-2 cm from the pylorus.

19. The apparatus according to claim 1, wherein all of the one or more electrodes are adapted to be placed 2-5 cm from the pylorus.

20. The apparatus according to claim 1, wherein all of the one or more electrodes are adapted to be placed 1-2 cm from the pylorus.

21. The apparatus according to claim 1, wherein the control unit is adapted to be placed in a gastrointestinal tract of the subject.

22. The apparatus according to claim 21, wherein the control unit is adapted to be placed in a stomach of the subject.

23. The apparatus according to claim 21, wherein the control unit is adapted to be implanted in the subject outside of the stomach, and to be wirelessly coupled to the electrodes.

24. The apparatus according to claim 21, wherein the control unit is adapted to be implanted in the subject outside of the stomach, and wherein the apparatus comprises wires configured to couple the control unit to the electrodes.

25. The apparatus according to claim 21, wherein the control unit is adapted to be placed outside of a body of the subject, and to be wirelessly coupled to the electrodes.

26. A method comprising:

applying a current to a wall of a duodenum of a subject;

configuring the current to stimulate a site selected from the group consisting of;

a vagus nerve of the subject, and enteric nervous system (ENS) tissue of the subject, in accordance with a set of parameters for the current, the set of parameters including a pulse width of pulses of the current and a frequency of application of the pulses; and

selecting the set of parameters to be such as to lower a level of glucose in blood of the subject and to be sufficient to cause closure of a pylorus of the subject.

27. The method according to claim 26, wherein the site includes the vagus nerve of the subject, and wherein configuring comprises configuring the current to stimulate the vagus nerve.

28. The method according to claim 26, wherein the site includes the ENS tissue of the subject, and wherein configuring comprises configuring the current to stimulate the ENS tissue.

29. The method according to claim 26, comprising sensing eating by the subject, wherein applying the current comprises applying the current responsively to the sensed eating.

30. The method according to claim 26, wherein configuring the current comprises selecting the set of parameters to be such as to increase a level of insulin in blood of the subject.

31. The method according to claim 26, wherein applying the current comprises:

placing a plurality of electrodes in contact with the wall of the duodenum such that two of the plurality of electrodes are mutually spaced by a distance that is greater than the spacing between any other two of the plurality of electrodes, when in contact with the wall, and wherein the distance is less than 3 cm; and

driving the plurality of electrodes to apply the current.

32. The method according to claim 26, wherein configuring comprises configuring the current to include a plurality of pulses, and setting a frequency of application of the pulses to be at least 0.1 Hz.

33. The method according to claim 32, wherein setting the frequency comprises setting the frequency to be at least 1 Hz.

34. The method according to claim 33, wherein setting the frequency comprises setting the frequency to be at least 3 Hz.

35. The method according to claim 26, wherein configuring comprises configuring the current to include a plurality of pulses, and wherein at least two consecutive ones of the pulses each have respective pulse widths that are less than 75 ms.

36. The method according to claim 35, wherein configuring comprises configuring the pulse widths to be less than 30 ms.

37. The method according to claim 36, wherein configuring comprises configuring the pulse widths to be less than 15 ms.

38. The method according to claim 26, wherein configuring the current comprises (a) configuring the current to include a plurality of pulses, (b) setting a frequency of application of the pulses to a desired frequency value, and (c) setting pulse widths of at least two consecutive pulses to be less than a threshold pulse width, wherein a ratio of the threshold pulse width to the desired frequency value is less than 1000 ms/Hz.

39. The method according to claim 38, wherein the ratio is less than 100 ms/Hz.

40. The method according to claim 39, wherein the ratio is less than 10 ms/Hz.

41. The method according to claim 26, wherein configuring the current comprises configuring the current to be sufficient to cause the closure of the pylorus via a nerve-mediated pathway, but to be insufficient to cause the closure of the pylorus via direct electrical stimulation of muscle tissue of the pylorus.

42. The method according to claim 26, wherein applying the current comprises:

placing a plurality of electrodes in contact with the wall of the duodenum, such that at least two of the plurality of electrodes are 2-5 cm from the pylorus; and

driving the electrodes to apply the current.

43. The method according to claim 26, wherein applying the current comprises:

placing a plurality of electrodes in contact with the wall of the duodenum, such that at least two of the plurality of electrodes are 1-2 cm from the pylorus; and

driving the electrodes to apply the current.

44. The method according to claim 26, wherein applying the current comprises:

placing one or more electrodes in contact with the wall of the duodenum such that all of the one or more electrodes are 2-5 cm from the pylorus; and

driving the electrodes to apply the current.

45. The method according to claim 26, wherein applying the current comprises:

placing one or more electrodes in contact with the wall of the duodenum such that all of the one or more electrodes are 1-2 cm from the pylorus; and

driving the electrodes to apply the current.