Gastro-intestinal electrical pacemaker

• US 6,243,607 B1
• Filed: 06/07/1999
• Issued: 06/05/2001
• Est. Priority Date: 09/05/1996
• Status: Expired due to Term

• Current Assignee: University Technologies International, Inc.
• Original Assignee: University Technologies International, Inc.
• Inventors: Bowes, Kenneth L., Mintchev, Martin P.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/254,364
• Time in Patent Office: 729 Days
• Field of Search: 607/40, 607/41, 607/2, 607/118, 607/116, 607/124, 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 device and method for electrical stimulation of a portion of the gastro-intestinal tract, defining a longitudinal axis. A proximal and at least one distal electrode set are arranged circumferentially about the portion of the gastro-intestinal tract in a plane substantially perpendicular to the longitudinal axis and in axially spaced relationship relative to each other. At least one power source provides an electrical stimulus to the electrode sets sufficient to stimulate the smooth muscle to produce a local circumferential contraction at each electrode set. A timing mechanism phase locks the electrical stimulus such that it is applied to the electrode sets successively and repetitively. The axially spaced relationship between the electrode sets and the timing of the electrical stimulus are selected such that the local circumferential contractions are artificially propagated distally through the portion of the gastro-intestinal tract.

Claims

1. A device for electrical stimulation of smooth muscle comprising a portion of the gastro-intestinal tract, wherein the portion of the gastro-intestinal tract defines a longitudinal axis extending therethrough, the device comprising:

(a) a proximal electrode set for arrangement circumferentially about the portion of the gastro-intestinal tract in a plane substantially perpendicular to the longitudinal axis such that the smooth muscle may be stimulated thereby to produce a local circumferential contraction of the smooth muscle at the location of the proximal electrode set, wherein the proximal electrode set is comprised of at least one active electrode and at least one ground electrode;

(b) at least one distal electrode set for arrangement circumferentially about the portion of the gastro-intestinal tract in a plane substantially perpendicular to the longitudinal axis and in axially spaced relationship relative to the proximal electrode set such that the smooth muscle may be stimulated thereby to produce a local circumferential contraction of the smooth muscle at the location of the distal electrode set, wherein each distal electrode set is comprised of at least one active electrode and at least one ground electrode;

(c) at least one power source for providing an electrical stimulus to the proximal and distal electrode sets sufficient to stimulate the smooth muscle to produce the local circumferential contractions;

(d) a timing mechanism, associated with the power source, for phase locking the electrical stimulus such that the electrical stimulus is applied to the proximal and distal electrode sets successively and repetitively;

wherein the axially spaced relationship between the electrode sets and the timing of the electrical stimulus applied to the electrode sets are selected such that the local circumferential contractions are artificially propagated distally through the portion of the gastro-intestinal tract.

2. The device as claimed in claim 1 wherein the portion of the gastro-intestinal tract is comprised of the esophagus, the stomach, the small intestine, the large intestine, the anal sphincter and combinations thereof.

3. The device as claimed in claim 2 wherein the portion of the gastro-intestinal tract is comprised of the stomach.

4. The device as claimed in claim 3 comprising at least three distal electrode sets located distally to the proximal electrode set and in an axially spaced relationship with each other such that the phase-locked electrical stimulus produces a local circumferential contraction at the proximal electrode set and each distal electrode set in succession.

5. The device as claimed in claim 4 comprising three distal electrode sets.

6. The device as claimed in claim 4 wherein the artificial propagation of local contractions through the stomach is sufficient to facilitate at least a partial emptying thereof.

7. The device as claimed in claim 6 wherein the proximal electrode set is located in about the mid-corpus of the stomach.

8. The device as claimed in claim 1 wherein the active electrodes are connected to the power source in a manner such that the electrical stimulus is provided concurrently to each of the active electrodes included in an electrode set.

9. The device as claimed in claim 3 wherein the distance between the electrodes in each of the proximal and distal electrode sets is between about 2 to 4 centimeters.

10. The device as claimed in claim 9 wherein the number of active electrodes is greater than or equal to the number of ground electrodes in each of the proximal and distal electrode sets.

11. The device as claimed in claim 9 wherein the electrical stimulus is provided by an alternating current source.

12. The device as claimed in claim 11 wherein the alternating current source is a bipolar alternating current source.

13. The device as claimed in claim 12 wherein the alternating current source is a rectangular alternating current source or a square alternating current source.

14. The device as claimed in claim 13 wherein the frequency of the alternating current source is between about 5 to 500 Hertz.

15. The device as claimed in claim 14 wherein the frequency of the alternating current source is between about 5 to 50 Hertz.

16. The device as claimed in claim 15 wherein the frequency of the alternating current source is about 50 Hertz.

17. The device as claimed in claim 16 wherein the voltage provided by the alternating current source is less than or equal to about 20 Volts, peak to peak.

18. The device as claimed in claim 17 wherein the voltage provided by the alternating current source is between about 10 to 20 Volts, peak to peak.

19. The device as claimed in claim 18 wherein the voltage provided by the alternating current source is between about 14 to 15 Volts, peak to peak.

20. The device as claimed in claim 18 wherein the timing mechanism applies the electrical stimulus such that the electrical stimulus is applied to the electrode set for an interval of between about 2 to 4 seconds, following which there is an equivalent interval of no stimulation before the application of the electrical stimulus to the next successive electrode set.

21. A method for electrical stimulation of smooth muscle comprising a portion of the gastro-intestinal tract, wherein the portion of the gastro-intestinal tract defines a longitudinal axis extending therethrough and wherein the method is performed using a device comprised of a proximal electrode set and at least one distal electrode set, the method comprising the steps of:

(a) arranging the proximal electrode set circumferentially about the portion of the gastro-intestinal tract in a plane substantially perpendicular to the longitudinal axis such that the smooth muscle may be stimulated thereby to produce a local circumferential contraction of the smooth muscle at the location of the proximal electrode set;

(b) arranging each of the distal electrode sets circumferentially about the portion of the gastro-intestinal tract in a plane substantially perpendicular to the longitudinal axis and in axially spaced relationship relative to the proximal electrode set such that the smooth muscle may be stimulated thereby to produce a local circumferential contraction of the smooth muscle at the location of the distal electrode set;

(c) applying an electrical stimulus to the proximal and distal electrode sets sufficient to stimulate the smooth muscle to produce the local circumferential contractions, wherein the electrical stimulus is phase-locked such that the electrical stimulus is applied to the proximal and distal electrode sets successively and repetitively;

wherein the axially spaced relationship between the electrode sets and the timing of the phase-locking of the electrical stimulus applied to the electrode sets are selected such that the local circumferential contractions are artificially propagated distally through the portion of the gastro-intestinal tract.

22. The method as claimed in claim 21 wherein the portion of the gastro-intestinal tract is comprised of the esophagus, the stomach, the small intestine, the large intestine, the anal sphincter and combinations thereof.

23. The method as claimed in claim 22 wherein the portion of the gastro-intestinal tract is comprised of the stomach.

24. The method as claimed in claim 23 wherein the proximal and distal electrode sets are implanted subserosally in the stomach.

25. The method as claimed in claim 24 wherein the device is comprised of at least three distal electrode sets and wherein the distal electrode sets are arranged distally to the proximal electrode set and in an axially spaced relationship with each other such that the phase-locked electrical stimulus produces a local circumferential contraction at the proximal electrode set and at each distal electrode set in succession.

26. The method as claimed in claim 25 wherein the device is comprised of three distal electrode sets.

27. The method as claimed in claim 25 wherein the artificial propagation of local contractions through the stomach is sufficient to facilitate at least a partial emptying thereof.

28. The method as claimed in claim 27 wherein the proximal electrode set is arranged in about the mid-corpus of the stomach.

29. The method as claimed in claim 27 wherein each of the proximal and distal electrode sets of the device is comprised of at least one active electrode and at least one ground electrode and wherein the electrical stimulus is applied to the active electrodes in a manner such that the electrical stimulus is applied concurrently to each of the active electrodes included in an electrode set.

30. The method as claimed in claim 29 wherein the distance between the electrodes in each of the proximal and distal electrode sets is between about 2 to 4 centimeters.

31. The method as claimed in claim 30 wherein the number of active electrodes is greater than or equal to the number of ground electrodes in each of the proximal and distal electrode sets.

32. The method as claimed in claim 30 wherein the electrical stimulus applied to the proximal and distal electrode sets is alternating.

33. The method as claimed in claim 32 wherein the alternating electrical stimulus is bipolar.

34. The method as claimed in claim 33 wherein the shape of the alternating electrical stimulus is rectangular or square.

35. The method as claimed in claim 34 wherein the frequency of the alternating electrical stimulus is between about 5 to 500 Hertz.

36. The method as claimed in claim 35 wherein the frequency of the alternating electrical stimulus is between about 5 to 50 Hertz.

37. The method as claimed in claim 36 wherein the frequency of the alternating electrical stimulus is about 50 Hertz.

38. The method as claimed in claim 37 wherein the voltage of the alternating electrical stimulus is less than or equal to about 20 Volts, peak to peak.

39. The method as claimed in claim 38 wherein the voltage of the alternating electrical stimulus is between about 10 to 20 Volts, peak to peak.

40. The method as claimed in claim 39 wherein the voltage of the alternating electrical stimulus is between about 14 to 15 Volts, peak to peak.

41. The method as claimed in claim 39 wherein the electrical stimulus is applied to the electrode set for an interval of between about 2 to 4 seconds, following which there is an equivalent interval of no stimulation before the application of the electrical stimulus to the next successive electrode set.

42. A method for electrical stimulation of smooth muscle comprising a portion of the gastro-intestinal tract, wherein the portion of the gastro-intestinal tract defines a longitudinal axis extending therethrough, the method comprising the steps of:

(a) applying an electrical stimulus at a proximal location to the smooth muscle circumferentially about the portion of the gastro-intestinal tract in a plane substantially perpendicular to the longitudinal axis, wherein the electrical stimulus is sufficient to stimulate the smooth muscle to produce a local circumferential contraction at the proximal location;

(b) applying an electrical stimulus at at least one distal location to the smooth muscle circumferentially about the portion of the gastro-intestinal tract in a plane substantially perpendicular to the longitudinal axis, wherein the distal location is in axially spaced relationship relative to the proximal location and wherein the electrical stimulus is sufficient to stimulate the smooth muscle to produce a local circumferential contraction at the distal location; and

(c) phase-locking the electrical stimulus applied at the proximal and distal locations such that the electrical stimulus is applied at the proximal and distal locations successively and repetitively;

wherein the axially spaced relationship between the proximal and distal locations and the timing of the phase-locking of the electrical stimulus applied to the locations are selected such that the local circumferential contractions are artificially propagated distally through the portion of the gastro-intestinal tract.

43. The method as claimed in claim 42 wherein the portion of the gastro-intestinal tract is comprised of the esophagus, the stomach, the small intestine, the large intestine, the anal sphincter and combinations thereof.

44. The method as claimed in claim 43 wherein the portion of the gastro-intestinal tract is comprised of the stomach.

45. The method as claimed in claim 44 wherein the electrical stimulus is applied at the proximal and distal locations subserosally in the stomach.

46. The method as claimed in claim 45 wherein the electrical stimulus is applied at at least three distal locations and wherein the distal locations are located distally to the proximal location and in an axially spaced relationship with each other such that the phase-locking of the electrical stimulus produces a local circumferential contraction at the proximal location and each distal location in succession.

47. The method as claimed in claim 46 wherein the electrical stimulus is applied at three distal locations.

48. The method as claimed in claim 46 wherein the artificial propagation of local contractions through the stomach is sufficient to facilitate at least a partial emptying thereof.

49. The method as claimed in claim 48 wherein the proximal location is located in about the mid-corpus of the stomach.

50. The method as claimed in claim 48 wherein the electrical stimulus applied at the proximal and distal locations is alternating.

51. The method as claimed in claim 50 wherein the alternating electrical stimulus is bipolar.

52. The method as claimed in claim 51 wherein the shape of the alternating electrical stimulus is rectangular or square.

53. The method as claimed in claim 52 wherein the frequency of the alternating electrical stimulus is between about 5 to 500 Hertz.

54. The method as claimed in claim 53 wherein the frequency of the alternating electrical stimulus is between about 5 to 50 Hertz.

55. The method as claimed in claim 54 wherein the frequency of the alternating electrical stimulus is about 50 Hertz.

56. The method as claimed in claim 55 wherein the voltage of the alternating electrical stimulus is less than or equal to about 20 Volts, peak to peak.

57. The method as claimed in claim 56 wherein the voltage of the alternating electrical stimulus is between about 10 to 20 Volts, peak to peak.

58. The method as claimed in claim 57 wherein the voltage of the alternating electrical stimulus is between about 14 to 15 Volts, peak to peak.

59. The method as claimed in claim 57 wherein the electrical stimulus is phase-locked such that the electrical stimulus is applied to the location for an interval of between about 2 to 4 seconds, following which there is an equivalent interval of no stimulation before the application of the electrical stimulus to the next successive location.