Gastrointestinal electrical stimulator having a variable electrical stimulus

• US 6,449,511 B1
• Filed: 04/14/2000
• Issued: 09/10/2002
• Est. Priority Date: 09/05/1996
• Status: Expired due to Term

• Current Assignee: Technologies International Inc.
• Original Assignee: University Technologies International, Inc.
• Inventors: Mintchev, Martin P., Bowes, Kenneth L.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/550,086
• Time in Patent Office: 879 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 a variable electrical stimulus to the electrode sets sufficient to stimulate the smooth muscle to produce a local circumferential contraction at each electrode set, wherein the electrical stimulus is variable between each of the proximal and distal electrode sets. A timing mechanism phase locks the electrical stimulus such that it is applied to the electrode sets successively, preferably in an overlapping manner, 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;

(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;

(c) at least one power source for providing a variable 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 variable between each of the proximal and distal electrode sets;

(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 timing mechanism applies the electrical stimulus to each electrode set for an interval of time in overlapping succession such that the application of the electrical stimulus to each electrode set ceases following the commencement of the application of the electrical stimulus to the next successive electrode set;

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 interval of time of application of the electrical stimulus to each electrode set is variable between successive electrode sets.

3. The device as claimed in claim 2 wherein the interval of time of application of the electrical stimulus to each electrode set decreases with each successive electrode set.

4. The device as claimed in claim 3 wherein the application of the electrical stimulus to each proximal and distal electrode sets ceases substantially concurrently.

5. 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 a variable 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 variable between each of the proximal and distal electrode sets, wherein the electrical stimulus is phase-locked such that the electrical stimulus is applied to the proximal and distal electrode sets successively and repetitively and wherein the applying step is comprised of applying the electrical stimulus to each electrode set for an interval of time in overlapping succession such that the application of the electrical stimulus to each electrode set ceases following the commencement of the application of the electrical stimulus to the next successive electrode set;

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.

6. The method as claimed in claim 5 wherein the interval of time of application of the electrical stimulus to each electrode set is variable between successive electrode sets.

7. The method as claimed in claim 6 wherein the interval of time of application of the electrical stimulus to each electrode set decreases with each successive electrode set.

8. The method as claimed in claim 7 wherein the application of the electrical stimulus to each proximal and distal electrode sets ceases substantially concurrently.

9. The method as claimed in claim 6 wherein the electrical stimulus applied to the proximal and distal electrode sets is alternating.

10. The method as claimed in claim 9 wherein the alternating electrical stimulus is bipolar.

11. The method as claimed in claim 10 wherein the shape of the alternating electrical stimulus is rectangular or square.

12. The method as claimed in claim 11 wherein the frequency of the alternating electrical stimulus is between about 5 to 500 Hertz and wherein the frequency of the alternating electrical stimulus is variable between each of the proximal and distal electrode sets.

13. The method as claimed in claim 12 wherein the frequency of the alternating electrical stimulus is between about 5 to 50 Hertz.

14. The method as claimed in claim 13 wherein the frequency of the alternating electrical stimulus is about 50 Hertz.

15. The method as claimed in claim 14 wherein the voltage of the alternating electrical stimulus is less than or equal to about 20 Volts, peak to peak, and wherein the applying step is comprised of varying the voltage of the alternating electrical stimulus between each of the proximal and distal electrode sets.

16. The method as claimed in claim 15 wherein the voltage of the alternating electrical stimulus is less than or equal to about 15 Volts, peak to peak, and wherein the applying step is comprised of decreasing the voltage of the alternating electrical stimulus applied to each successive electrode set.

17. The method as claimed in claim 16 wherein the voltage of the alternating electrical stimulus is between about 4 to 14 Volts, peak to peak.

18. The method as claimed in claim 17 wherein the applying step is comprised of applying the electrical stimulus to each successive electrode set for an interval of time of less than or equal to about 24 seconds.

19. The method as claimed in claim 18 wherein the interval of time is between about 4 to 24 seconds.

20. 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, wherein the electrical stimulus is sufficient to stimulate the smooth muscle to produce a local circumferential contraction at the distal location and wherein the applied electrical stimulus is varied between each of the proximal and distal locations; 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 phase-locking step is comprised of applying the electrical stimulus at each location for an interval of time in overlapping succession such that the application of the electrical stimulus at each location ceases following the commencement of the application of the electrical stimulus at the next successive location;

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.

21. The method as claimed in claim 20 wherein the interval of time of application of the electrical stimulus at each proximal and distal location is variable between successive locations.

22. The method as claimed in claim 21 wherein the interval of time of application of the electrical stimulus at each location decreases with each successive location.

23. The method as claimed in claim 22 wherein the application of the electrical stimulus at each proximal and distal location ceases substantially concurrently.

24. 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;

(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;

(c) at least one power source for providing a variable 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 variable between each of the proximal and distal electrode sets;

(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 timing mechanism applies the electrical stimulus to each electrode set for an interval of time in overlapping succession such that the application of the electrical stimulus to each electrode set ceases following the commencement of the application of the electrical stimulus to all successive electrode sets;

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.

25. The device as claimed in claim 24 wherein the application of the electrical stimulus to each proximal and distal electrode sets ceases substantially concurrently.

26. The device as claimed in claim 25 wherein the timing mechanism applies the electrical stimulus to the proximal and distal electrode sets such that the electrical stimulus is applied to the proximal and distal electrode sets in succession for a period of stimulation, following which there is a period of no stimulation before the next application of the electrical stimulus to the proximal and distal electrode sets.

27. The device as claimed in claim 26 wherein the period of no stimulation is substantially equal to the period of stimulation.

28. The device as claimed in claim 26 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.

29. The device as claimed in claim 28 wherein the portion of the gastro-intestinal tract is comprised of the stomach.

30. The device as claimed in claim 29 comprising at least three distal electrode sets for arrangement circumferentially about the portion of the gastro-intestinal tract 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.

31. The device as claimed in claim 30 wherein the artificial propagation of local contractions through the stomach is sufficient to facilitate at least a partial emptying thereof.

32. The device as claimed in claim 31 wherein the proximal electrode set is for arrangement circumferentially about the mid-corpus of the stomach.

33. The device as claimed in claim 32 wherein each of the proximal and distal electrode sets is comprised of at least one active electrode and at least one ground electrode, 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.

34. The device as claimed in claim 33 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.

35. The device as claimed in claim 33 wherein the electrical stimulus is provided by an alternating voltage source.

36. The device as claimed in claim 35 wherein the alternating voltage source is a bipolar alternating voltage source.

37. The device as claimed in claim 36 wherein the alternating voltage source is a rectangular alternating voltage source or a square alternating voltage source.

38. The device as claimed in claim 37 wherein the frequency of the alternating voltage source is between about 5 to 500 Hertz and wherein the frequency of the alternating voltage source is variable between each of the proximal and distal electrode sets.

39. The device as claimed in claim 38 wherein the frequency of the alternating voltage source is between about 5 to 50 Hertz.

40. The device as claimed in claim 39 wherein the frequency of the alternating voltage source is about 50 Hertz.

41. The device as claimed in claim 40 wherein the voltage provided by the alternating voltage source is less than or equal to about 20 Volts, peak to peak, and wherein the voltage of the alternating voltage source is variable between each of the proximal and distal electrode sets.

42. The device as claimed in claim 41 wherein the voltage provided by the alternating voltage source is less than or equal to about 15 Volts, peak to peak.

43. The device as claimed in claim 42 wherein the voltage provided by the alternating voltage source is between about 4 to 14 Volts, peak to peak.

44. The device as claimed in claim 43 wherein the interval of time of the application of the electrical stimulus to each proximal and distal electrode set is less than or equal to about 24 seconds.

45. The device as claimed in claim 44 wherein the interval of time is between about 4 to 24 seconds.

46. 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 a variable 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 variable between each of the proximal and distal electrode sets, wherein the electrical stimulus is phase-locked such that the electrical stimulus is applied to the proximal and distal electrode sets successively and repetitively and wherein the applying step is comprised of applying the electrical stimulus to each electrode set for an interval of time in overlapping succession such that the application of the electrical stimulus to each electrode set ceases following the commencement of the application of the electrical stimulus to all successive electrode sets;

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.

47. The method as claimed in claim 46 wherein the application of the electrical stimulus to each proximal and distal electrode sets ceases substantially concurrently.

48. The method as claimed in claim 47 wherein the applying step is comprised of applying the electrical stimulus to the proximal and distal electrode sets such that the electrical stimulus is applied to the proximal and distal electrode sets in succession for a period of stimulation, following which there is a period of no stimulation before the next application of the electrical stimulus to the proximal and distal electrode sets.

49. The method as claimed in claim 48 wherein the period of no stimulation is substantially equal to the period of stimulation.

50. The method as claimed in claim 48 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.

51. The method as claimed in claim 50 wherein the portion of the gastro-intestinal tract is comprised of the stomach.

52. The method as claimed in claim 51 wherein the proximal and distal electrode sets are implanted subserosally in the stomach.

53. The method as claimed in claim 51 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.

54. The method as claimed in claim 53 wherein the artificial propagation of local contractions through the stomach is sufficient to facilitate at least a partial emptying thereof.

55. The method as claimed in claim 54 wherein the proximal electrode set is arranged in about the mid-corpus of the stomach.

56. 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, wherein the electrical stimulus is sufficient to stimulate the smooth muscle to produce a local circumferential contraction at the distal location and wherein the applied electrical stimulus is varied between each of the proximal and distal locations; 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 phase-locking step is comprised of applying the electrical stimulus at each location for an interval of time in overlapping succession such that the application of the electrical stimulus at each location ceases following the commencement of the application of the electrical stimulus at all successive locations;

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.

57. The method as claimed in claim 56 wherein the application of the electrical stimulus at each proximal and distal location ceases substantially concurrently.

58. The method as claimed in claim 57 wherein the phase-locking step is comprised of applying the electrical stimulus at the proximal and distal locations such that the electrical stimulus is applied at the proximal and distal locations in succession for a period of stimulation, following which there is a period of no stimulation before the next application of the electrical stimulus at the proximal and distal locations.

59. The method as claimed in claim 58 wherein the period of no stimulation is substantially equal to the period of stimulation.

60. The method as claimed in claim 58 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.

61. The method as claimed in claim 60 wherein the portion of the gastro-intestinal tract is comprised of the stomach.

62. The method as claimed in claim 61 wherein the electrical stimulus is applied at the proximal and distal locations subserosally in the stomach.

63. The method as claimed in claim 62 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.

64. The method as claimed in claim 63 wherein the artificial propagation of local contractions through the stomach is sufficient to facilitate at least a partial emptying thereof.

65. The method as claimed in claim 64 wherein the proximal location is located in about the mid-corpus of the stomach.

66. The method as claimed in claim 65 wherein the electrical stimulus applied at the proximal and distal locations is alternating.

67. The method as claimed in claim 66 wherein the alternating electrical stimulus is bipolar.

68. The method as claimed in claim 67 wherein the shape of the alternating electrical stimulus is rectangular or square.

69. The method as claimed in claim 68 wherein the frequency of the alternating electrical stimulus is between about 5 to 500 Hertz and wherein the frequency of the alternating electrical stimulus is variable between each of the proximal and distal locations.

70. The method as claimed in claim 69 wherein the frequency of the alternating electrical stimulus is between about 5 to 50 Hertz.

71. The method as claimed in claim 70 wherein the frequency of the alternating electrical stimulus is about 50 Hertz.

72. The method as claimed in claim 71 wherein the voltage of the alternating electrical stimulus is less than or equal to about 20 Volts, peak to peak, and wherein the voltage of the alternating electrical stimulus applied at the proximal location varies from the voltage of the alternating electrical stimulus applied at each successive distal location.

73. The method as claimed in claim 72 wherein the voltage of the alternating electrical stimulus is less than or equal to about 15 Volts, peak to peak, and wherein a decreasing voltage is applied at each successive location.

74. The method as claimed in claim 73 wherein the voltage of the alternating electrical stimulus is between about 4 to 14 Volts, peak to peak.

75. The method as claimed in claim 74 wherein the phase-locking step is comprised of applying the electrical stimulus at each successive location for an interval of time of less than or equal to about 24 seconds.

76. The method as claimed in claim 75 wherein the interval of time is between about 4 to 24 seconds.