Apparatus and method for treating chronic constipation

• US 6,238,423 B1
• Filed: 09/30/1999
• Issued: 05/29/2001
• Est. Priority Date: 01/13/1997
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bardy, Gust H.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/409,230
• Time in Patent Office: 607 Days
• Field of Search: 607/40, 607/41, 607/116, 607/133, 607/130
• US Class Current: 607/40
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

An anticonstipation apparatus, and method, that may include using an implanted stimulus generator that may supply electrical stimuli to the muscles associated with a target portion of the patient'"'"'s gut, from the esophagus to the anus, through an electrical lead and several pairs of electrodes. The electrical stimuli may be provided to nerves in the autonomic nervous system that are associated with the muscles, or the stimuli may be provided directly to the muscles themselves. The stimuli may be provided sequentially, in a proximal to caudad direction, in order to initiate, enhance or artificially produce peristalsis in the gut'"'"'s target portion in a proximal to caudad direction. If the gut'"'"'s target portion is in the descending colon, such stimulation may be coordinated with similar stimulation of the muscles associated with the rectum and anus. A sensor may be provided to detect when the target portion is experiencing constipation.

Claims

1. An anticonstipation apparatus for treating constipation in a human patient, comprising:

electrode means for delivering sequential electrical stimulation to muscles that are associated with a target portion of the gut of said patient;

stimulus generator means for generating said sequential electrical stimulation; and

electrical lead means adapted to convey said sequential electrical stimulation from said stimulus generator means to said electrode means;

wherein said muscles are located sequentially with respect to each other in a proximal to caudad direction and the electrode means are adapted to stimulate same;

wherein said sequential electrical stimulation is selected to urge said muscles to sequentially contract, in said proximal to caudad direction, to urge at least a portion of the contents of said target portion to move in said proximal to caudad direction, and wherein said electrical lead means comprises an electrical lead, said electrical lead comprising an electrode portion having a flexible, flat, ribbon-like configuration, at least a portion of said electrode means being located on a first face of said electrode portion wherein said electrode means further comprises from two to 100 pairs of electrodes.

2. The anticonstipation apparatus according to claim 1, wherein at least some of said muscles are located in a wall of said target portion;

and wherein at least portions of said electrode means are configured and adapted to deliver said sequential electrical stimulation directly to said muscles located in said wall.

3. The anticonstipation apparatus according to claim 1, wherein at least portions of said electrode means are configured and adapted to deliver said electrical stimulation to at least one portion of the autonomic nervous system associated with at least some of said muscles.

4. The anticonstipation apparatus according to claim 1:

wherein said apparatus further comprises constipation sensing means for sensing when at least a portion of said target portion is constipated, and for generating a constipated signal when at least a portion of said target portion is constipated;

wherein at least portions of said electrical lead means are configured and adapted to deliver said constipated signal from said constipation sensing means to said stimulus generator means; and

wherein said stimulus generator means is configured to commence said delivery of said sequential electrical stimulation, after receiving said constipated signal from said constipation sensing means.

5. The anticonstipation apparatus according to claim 4, wherein said constipation sensing means further comprises a motion sensor means for sensing any peristaltic waves generated by said target portion.

6. The anticonstipation apparatus according to claim 4, wherein said constipation sensing means further comprises a pressure sensor means for sensing the pressure within said target portion.

7. The anticonstipation apparatus according to claim 4, wherein said constipation sensing means further comprises a strain gauge means for sensing the tension in a wall of said target portion.

8. The anticonstipation apparatus according to claim 4, wherein said constipation sensing means further comprises impedance sensing means for sensing the impedance of at least a portion of a wall of said target portion.

9. The anticonstipation apparatus according to claim 4, wherein said constipation sensing means further comprises a saddle means for sensing the shape of a wall of said target portion.

10. The anticonstipation apparatus according to claim 1, wherein said electrodes in at least one of said pairs of electrodes are generally rectangular, have a width in the range of from about 1 mm to about 10 mm, and a length in the range of from about 2 mm to about 20 mm.

11. The anticonstipation apparatus according to claim 1, wherein said electrodes in at least one of said pairs of electrodes have a separation from each other in the range of from about 1 mm to about 100 mm.

12. The anticonstipation apparatus according to claim 1, wherein at least two pairs of said electrodes have a separation from each other in the range of from about 1 cm to about 10 cm.

13. The anticonstipation apparatus according to claim 1, wherein said sequential electrical stimulation is delivered sequentially to at least two pairs of said electrodes in said proximal to caudad direction.

14. The anticonstipation apparatus according to claim 1, wherein said target portion further comprises at least a portion of the colon of said patient.

15. The anticonstipation apparatus according to claim 1, wherein said target portion further comprises a first target portion comprising at least a portion of the descending colon of said patient.

16. The anticonstipation apparatus according to claim 15, wherein said target portion further comprises a second target portion comprising at least a portion of the rectum of said patient.

17. The anticonstipation apparatus according to claim 16, wherein said sequential electrical stimulation is delivered to said muscles associated with said first target portion, before said sequential electrical stimulation is delivered to said muscles associated with said second target portion, to urge at least a portion of the contents of said first and second target portions to move sequentially from said first target portion to said second target portion, in said proximal to caudad direction.

18. The anticonstipation apparatus according to claim 1, wherein said target portion further comprises at least a portion of the small intestine of said patient.

19. The anticonstipation apparatus according to claim 1, wherein said target portion further comprises at least a portion of the stomach of said patient.

20. The anticonstipation apparatus according to claim 1, wherein said target portion further comprises at least a portion of the esophagus of said patient.

21. The anticonstipation apparatus according to claim 1, wherein said sequential electrical stimulation further comprises at least two sequential electrical stimuli;

and wherein at least one of said stimuli has a voltage in the range of from about 20 microvolts to about 50 volts.

22. The anticonstipation apparatus according to claim 1, wherein said sequential electrical stimulation further comprises at least two sequential electrical stimuli;

and wherein at least one of said stimuli has a duration in the range of from about 20 microseconds to about 20 milliseconds.

23. The anticonstipation apparatus according to claim 1, wherein said sequential electrical stimulation further comprises at least two sequential electrical stimuli;

and wherein at least one of said stimuli comprises at least one uniphasic electrical stimulus.

24. The anticonstipation apparatus according to claim 1, wherein said sequential electrical stimulation further comprises at least two sequential electrical stimuli;

and wherein at least one of said stimuli comprises at least one biphasic electrical stimulus.

25. The anticonstipation apparatus according to claim 1, wherein said sequential electrical stimulation further comprises at least two sequential electrical stimuli;

and wherein at least one of said stimuli comprises at least one multiphasic electrical stimulus.

26. The anticonstipation apparatus according to claim 1, wherein said sequential electrical stimulation further comprises from one to ten sets of sequential electrical stimuli.

27. The anticonstipation apparatus according to claim 26:

wherein each said set of sequential electrical stimuli further comprises from two to one hundred sequential included electrical stimuli; and

wherein said sequential included electrical stimuli further are delivered sequentially to respective pairs of said electrodes.

28. The anticonstipation apparatus according to claim 27, wherein at least one of said sequential included electrical stimuli further comprises from one to about 100 electrical pulses.

29. The anticonstipation apparatus according to claim 1:

wherein said sequential electrical stimulation further comprises at least two sets of sequential electrical stimuli; and

wherein said at least two sets of sequential electrical stimuli further have a separation from each other in the range of from about 20 microseconds to about 60 seconds.

30. An anticonstipation method for treating constipation in a human patient, wherein an implantable electrical lead means comprising electrode means is employed in said method, said electrical lead comprising an electrode portion having a flexible, flat, ribbon-like configuration, at least a portion of said electrode means being located on a first face of said electrode portion, said method comprising the steps of:

selecting muscles that are associated with a target portion of the gut of said patient, wherein said muscles are located sequentially with respect to each other in said proximal to caudad direction;

implanting in said patient said electrode means for delivering sequential electrical stimulation to said muscles;

selecting said sequential electrical stimulation to urge said muscles to sequentially contract, in said proximal to caudad direction, to urge at least a portion of the contents of said target portion to move in said proximal to caudad direction; and

delivering said sequential electrical stimulation to said muscles by using said electrode means.

31. A method according to claim 30:

wherein said selecting muscles step further comprises the step of selecting at least some of said muscles to be located in the wall of said target portion; and

wherein said implanting step further comprises implanting said electrode means in a location selected to enable said electrode means to deliver said electrical stimulation directly to said muscles that are located in a wall.

32. A method according to claim 30, wherein said implanting step further comprises the step of implanting said electrode means in a location selected to enable said electrode means to deliver said electrical stimulation to at least one portion of the autonomic nervous system associated with at least some of said muscles.

33. A method according to claim 30, further comprising the steps of:

implanting in said patient constipation sensing means for sensing when at least a portion of said target portion is constipated, and for generating a constipated signal when at least a portion of said target portion is constipated; and

commencing said delivering step after said constipation sensing means has generated said constipated signal.

34. A method according to claim 30, wherein said selecting muscles step further comprises the step of selecting said target portion to comprise a first target portion comprising at least a portion of the descending colon of said patient.

35. A method according to claim 34, wherein said selecting muscles step further comprises the step of selecting said target portion to comprise a second target portion comprising at least a portion of the rectum of said patient.

36. A method according to claim 35, wherein said delivering step further comprises the steps of first delivering said sequential electrical stimulation to said muscles associated with said first target portion, and then delivering said sequential electrical stimulation to said muscles associated with said second target portion, to urge at least a portion of the contents of said first and second target portions to move from said first target portion to said second target portion, in said proximal to caudad direction.

37. An anticonstipation apparatus for treating constipation in a human patient, wherein said apparatus comprises:

electrode means for delivering electrical stimulation to muscles that are associated with a target portion of the gut of said patient;

stimulus generator means for generating said electrical stimulation; and

electrical lead means for conveying said electrical stimulation from said stimulus generator means to said electrode means;

wherein said electrical stimulation is selected to urge said muscles to contract, to urge at least a portion of the contents of said target portion to move in a proximal to caudad direction, and said electrical lead means comprises an electrical lead, said electrical lead comprising an electrode portion having a flexible, flat, ribbon-like configuration, at least a portion of said electrode means being located on a first face of said electrode portion wherein said electrode means further comprises from two to 100 pairs of electrodes.

38. The anticonstipation apparatus according to claim 37, wherein at least some of said muscles are located in the wall of said target portion, and said electrode means is for delivering said electrical stimulation directly to said muscles that are located in a wall.

39. The anticonstipation apparatus according to claim 37, wherein said electrode means is for delivering said electrical stimulation to at least one portion of the autonomic nervous system that is associated with at least some of said muscles.

40. The anticonstipation apparatus according to claim 37:

wherein said apparatus further comprises constipation sensing means for sensing when at least a portion of said target portion is constipated, and for generating a constipated signal when at least a portion of said target portion is constipated;

wherein said electrical lead means is also for delivering said “

constipated”

signal from said constipation sensing means to said stimulus generator means; and

wherein said stimulus generator means is also for commencing said delivering of said electrical stimulation, after receiving said constipated signal from said constipation sensing means.

41. The anticonstipation apparatus according to claim 40, wherein said constipation sensing means comprises a motion sensor means for sensing any peristaltic waves generated by said target portion.

42. The anticonstipation apparatus according to claim 40, wherein said constipation sensing means comprises a pressure sensor means for sensing the pressure within said target portion.

43. The anticonstipation apparatus according to claim 40, wherein said constipation sensing means comprises a strain gauge means for sensing the tension in a wall of said target portion.

44. The anticonstipation apparatus according to claim 40, wherein said constipation sensing means comprises impedance sensing means for sensing the impedance of at least a portion of a wall of said target portion.

45. The anticonstipation apparatus according to claim 40, wherein said constipation sensing means comprises a saddle means for sensing the shape of a wall of said target portion.

46. The anticonstipation apparatus according to claim 37, wherein at least one of said electrodes is generally rectangular, having a width in the range of from about 1 mm to about 10 mm, and having a length in the range of from about 2 mm to about 20 mm.

47. The anticonstipation apparatus according to claim 46, wherein said electrodes in a pair of electrodes have a separation from each other in the range of from about 1 mm to about 100 mm.

48. The anticonstipation apparatus according to claim 37, wherein said target portion comprises at least a portion of the colon of said patient.

49. The anticonstipation apparatus according to claim 37, wherein said target portion comprises a first target portion comprising at least a portion of the descending colon of said patient.

50. The anticonstipation apparatus according to claim 49, wherein said target portion further comprises a second target portion comprising at least a portion of the rectum of said patient.

51. The anticonstipation apparatus according to claim 50, wherein said electrical stimulation is delivered to said muscles that are associated with said first target portion, before said electrical stimulation is delivered to said muscles that are associated with said second target portion, to urge at least a portion of the contents of said first and second target portions to move sequentially from said first target portion to said second target portion, in said proximal to caudad direction.

52. The anticonstipation apparatus according to claim 37, wherein said target portion comprises at least a portion of the small intestine of said patient.

53. The anticonstipation apparatus according to claim 37, wherein said target portion comprises at least a portion of the stomach of said patient.

54. The anticonstipation apparatus according to claim 37, wherein said target portion comprises at least a portion of the esophagus of said patient.

55. The anticonstipation apparatus according to claim 37, wherein said electrical stimulation comprises at least one electrical stimulus having a voltage in the range of from about 20 microvolts to about 50 volts.

56. The anticonstipation apparatus according to claim 37, wherein said electrical stimulation comprises at least one electrical stimulus having a duration in the range of from about 20 microseconds to about 20 milliseconds.

57. The anticonstipation apparatus according to claim 37, wherein said electrical stimulation comprises at least one electrical stimulus comprising at least one uniphasic electrical stimulus.

58. The anticonstipation apparatus according to claim 37, wherein said electrical stimulation comprises at least one electrical stimulus comprising at least one biphasic electrical stimulus.

59. The anticonstipation apparatus according to claim 37, wherein said electrical stimulation comprises at least one electrical stimulus comprising at least one multiphasic electrical stimulus.

60. The anticonstipation apparatus according to claim 37, wherein said electrical stimulation comprises from one to about ten sets of electrical stimuli.

61. The anticonstipation apparatus according to claim 60, wherein each said set of electrical stimuli comprises from one to about one hundred included electrical stimuli.

62. The anticonstipation apparatus according to claim 61, wherein at least one of said included electrical stimuli comprises from one to about 100 electrical pulses.

63. The anticonstipation apparatus according to claim 37:

wherein said electrical stimulation comprises at least two sets of electrical stimuli; and

wherein said at least two sets of electrical stimuli have a separation from each other in the range of from about 20 microseconds to about 60 seconds.

64. An anticonstipation method for treating constipation in a human patient, wherein an implantable electrical lead means comprising electrode means is employed in said method, said electrical lead comprising an electrode portion having a flexible, flat, ribbon-like configuration, at least a portion of said electrode means being located on a first face of said electrode portion, said method comprising the steps of:

selecting muscles that are associated with a target portion of the gut of said patient;

implanting in said patient electrode means for delivering electrical stimulation to said muscles;

selecting said electrical stimulation to urge said muscles to contract, to urge at least a portion of the contents of said target portion to move in a proximal to caudad direction; and

delivering said electrical stimulation to said muscles by using said electrode means.

65. A method according to claim 64:

wherein said selecting muscles step further comprises the step of selecting at least some of said muscles to be located in a wall of said target portion, and

wherein said implanting step further comprises implanting said electrode means in a location selected to enable said electrode means to deliver said electrical stimulation directly to said muscles that are located in said wall.

66. A method according to claim 64, wherein said implanting step further comprises the step of implanting said electrode means in a location selected to enable said electrode means to deliver said electrical stimulation to at least one portion of the autonomic nervous system that is associated with at least some of said muscles.

67. A method according to claim 64, further comprising the steps of:

implanting in said patient constipation sensing means for sensing when at least a portion of said target portion is constipated, and for generating a constipated signal when at least a portion of said target portion is constipated; and

commencing said delivering step after said constipation sensing means has generated said constipated signal.

68. A method according to claim 64, wherein said selecting muscles step further comprises the step of selecting said target portion to comprise a first target portion comprising at least a portion of the descending colon of said patient.

69. A method according to claim 68, wherein said selecting muscles step further comprises the step of selecting said target portion to comprise a second target portion comprising at least a portion of the rectum of said patient.

70. A method according to claim 69, wherein said delivering step further comprises the steps of first delivering said electrical stimulation to said muscles that are associated with said first target portion, and then delivering said electrical stimulation to said muscles that are associated with said second target portion, to urge at least a portion of the contents of said first and second target portions to move from said first target portion to said second target portion, in said proximal to caudad direction.