Method and apparatus for control of bowel function

• US 6,658,297 B2
• Filed: 09/07/2001
• Issued: 12/02/2003
• Est. Priority Date: 09/07/2000
• Status: Expired due to Term

• Current Assignee: The Alfred E. Mann Institute For Biomedical Engineering At The University Of Southern California (University of Southern California)
• Original Assignee: The Alfred E. Mann Institute For Biomedical Engineering At The University Of Southern California (University of Southern California)
• Inventors: Loeb, Gerald E.
• Primary Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US09/949,424
• Publication Number:
  US 20020072779A1
• Time in Patent Office: 816 Days
• Field of Search: 607/40, 607/133, 600/547, 600/29, 600/30
• US Class Current: 607/40
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

Spinal cord injury and other injuries and diseases of the nervous system often result in the inability to sense the need to empty the rectum or to control the timing of bowel movements. This invention includes microminiature electronic devices implanted on or around the large bowel to sense the volume and nature of rectal contents and to stimulate peristaltic contractions to empty the large bowel when it is convenient for the patient to do so.

Claims

1. A system for controlling bowel function, the system comprising:

a first electronic device adapted to be implanted in the body and to detect distension of the rectum;

a second electronic device adapted to be implanted in the body and to trigger peristaltic evacuation of the bowel; and

an external electronic device coupled to an inductive coil.

2. The system of claim 1 wherein the first and second electronic devices measure the distance between the first and second electronic devices by emitting an electromagnetic field and measuring the strength of the electromagnetic field.

3. The system of claim 2 wherein the first and second electronic devices measure the electrical coupling provided by a material between the first and second electronic devices by emitting an electrical current and measuring the strength of a potential field.

4. The system of claim 3 wherein the external electronic device computes an electrical resistance of the material between the first and second electronic devices.

5. The system of claim 1 further comprising an electrical stimulator adapted for implantation in a rectoanal region.

6. The system of claim 5 further comprising an electrical stimulator for activating a plurality of preganglionic parasympathetic neurons to trigger defecation.

7. The system of claim 5 further comprising an electrical stimulator for activating a plurality of perianal cutaneous afferents to activate spinal reflexes to result in defecation.

8. The system of claim 5 wherein the external electronic device includes an interface to permit activation of the electrical stimulator.

9. The system of claim 1 wherein the first and second implanted electronic devices receive power and command signals by an electromagnetic coupling to the external electronic device.

10. The system of claim 9 wherein a class E electronic power oscillator that is 100% modulated in fewer than four carrier cycles electromagnetically couples the first and second electronic devices and the external electronic device.

11. The system of claim 9 wherein the inductive coil electromagnetically couples the first and second electronic devices and the external electronic device.

12. The system of claim 1 wherein the first and second electronic devices communicate with the inductive coil.

13. The system of claim 12 wherein the inductive coil is removably coupled to a toilet.

14. The system of claim 12 wherein the inductive coil is removably coupled to a seat cushion.

15. The system of claim 12 wherein the inductive coil is removably coupled to a mattress.

16. A method for determining the state of material in the rectum by measuring the electrical resistance of the material in the rectum, the method comprising:

implanting first and second microelectrical devices in the rectal walls so as to stimulate peristaltic contractions; and

emitting a brief electrical current from the first microelectrical device; and

measuring the strength of the electrical field at the second microelectrical device.

17. A method for determining the state of material in the rectum by measuring the electrical resistance of the material in the rectum, the method comprising:

implanting first and second microelectrical devices in the rectal walls;

emitting a brief electrical current from the first microelectrical device;

measuring the strength of the electrical field at the second microelectrical device; and

transmitting the measurement recorded at the second microelectrical device to an external controller which uses information about the distance and electrical coupling of the first and second microelectronic devices to infer the resistance and nature of the material in the rectum.

18. The method of claim 17, wherein the first electronic device and the second electronic device are configured to be separately positionable in the body.

19. The device of claim 17, wherein first and second electronic devices are adapted for positioning by injection.

20. A method for measuring physical distension of the rectum, the method comprising:

implanting first and second microelectrical devices in the rectal walls so as to stimulate peristaltic contractions; and

emitting a short burst of RF energy from the first microelectrical device;

and measuring the strength of the short burst of RF energy at the second microelectrical device.

21. A method for measuring physical distension of the rectum, the method comprising:

implanting first and second microelectrical devices in the rectal walls so as to stimulate peristaltic contractions;

emitting a short burst of RF energy from the first microelectrical device;

measuring the strength of the short burst of RF energy at the second microelectrical device; and

transmitting the measurement recorded at the second microelectrical device to an external controller which uses information about the distance and electrical coupling of the first and second microelectronic devices to infer the amount and nature of the rectal distention.

22. The method of claim 21, wherein the first electronic device and the second electronic device are configured to be separately positionable in the body.

23. The device of claim 21, wherein first and second electronic devices are adapted for positioning by injection.

24. The method of claim 21, wherein the electromagnetic field is a radiofrequency field.

25. A device for use in detecting the state of material in the body by measuring the electrical resistance of the material, comprising:

a) a first electronic device for generating an electrical current, the first electrical device adapted for implantation in the body;

b) a second electronic device configured to detect a potential field, the second electrical device adapted for implantation in the body;

c) an external electronic device in communication with the second electronic device for detecting a signal indicative of the strength of the potential field detected by the second electrical device, the external electronic device using the signal to determine the state of material between the first and second electrical devices.

26. The device of claim 25, wherein the external electronic device is electromagnetically coupled to the first electronic device and second electronic device by an inductive coil.

27. The device of claim 25, wherein the first electronic device comprises a first capsule in communication with two electrodes and wherein the second electronic device comprises a capsule in communication with two electrodes.

28. The device of claim 25, wherein the electronic device further comprises a user interface for displaying the results of measurements to a user.

29. The device of claim wherein the external electronic device further comprises a controller in communication with the first or second electronic devices, whereby activation of the controller causes the emission of an electrical current from the first or second electronic devices, and wherein the electrical current stimulates peristaltic contractions.

30. The device of claim 25, wherein the external electronic device further comprises a controller in communication with an electrical stimulator whereby activation of the controller causes the emission of an electrical current from the electronic device, and wherein the electrical current stimulates peristaltic contractions.

31. The device of claim 25, wherein the first electronic device and the second electronic device are separately positionable.

32. The device of claim 25, wherein the first electronic device is positioned on the opposite side of the bowel from the second electronic device.

33. The device of claim 25, wherein the first and second electronic devices are positioned in one location selected from the group comprising:

the walls of the bowel, the serosal surface of the bowel, the walls of the rectum, or the serosal surface of the rectum.

34. The device of claim 25, wherein first and second electronic devices are adapted for positioning by injection.

35. The device of claim 24, wherein the external electronic device transmits power to the first or second electronic device by generating a modulated electromagnetic field.

36. The device of claim 25, wherein the external electronic device transmits command signals to the first or second electronic device by generating a modulated electromagnetic field.

37. The device of claim 25, wherein the external electronic device comprises:

a) a user interface in operable communication with a controller;

b) a driver for creating an electromagnetic signal; and

c) optionally a detector for detecting electromagnetic signals.

38. The device of claim 35, further comprising an electrical stimulator configured for implantation in the proximity of one of the rectoanal region, a preganglionic parasympathetic neuron, or a perianal cutaneous afferent.

39. The device of claim 40, wherein the electromagnetic field is a radiofrequency field.

40. A device for use in detecting tissue distension by measuring mutual electromagnetic coupling, comprising:

a) a first electronic device for generating an electromagnetic field, the first electrical device adapted for implantation in the body;

b) a second electronic device configured to detect an electromagnetic field, the second electrical device adapted for implantation in the body; and

c) an external electronic device in communication with the second electronic device for detecting a signal indicative of the strength of the electromagnetic field detected by the second electrical device, the external electronic device using the signal to determine the degree of tissue distention between the first and second electrical devices.

41. The device of claim 40, wherein the external electronic device is electromagnetically coupled to the first electronic device and second electronic device by an inductive coil.

42. The device of claim 40, wherein the first electronic device and the second electronic device are separately positionable.

43. The device of claim 40, wherein the first electronic device is positioned on the opposite side of the bowel from the second electronic device.

44. The device of claim 40, wherein the first and second electronic devices are positioned in one location selected from the group comprising:

the walls of the bowel, the serosal surface of the bowel, the walls of the rectum, or the serosal surface of the rectum.

45. The device of claim 40, wherein first and second electronic devices are dared for positioning by injection.

46. The device of claim 40, wherein the external electronic device transmits power to the first or second electronic device by generating a modulated electromagnetic field.

47. The device of claim 40, wherein the external electronic device transmits command signals to the first or second electronic device by generating a modulated electromagnetic field.

48. The device of claim 40, wherein the external electronic device comprises:

a) a user interface in operable communication with a controller;

b) a driver for creating an electromagnetic signal; and

c) optionally a detector for detecting electromagnetic signals.

49. The device of claim 40, further comprising an electrical stimulator configured for implantation in the proximity of one of the rectoanal region, a preganglionic parasympathetic neuron, or a perianal cutaneous afferent.

50. A device for use in the control of gastrointestinal function, comprising:

a) an external electronic device for generating control signals;

b) a first electronic device in communication with the external electronic device, including a component for emitting a signal to a second implanted electronic device; and

c) the second electronic device in communication with the external electronic device, including a component for measuring a signal from the first implanted electronic device and communicating measurement information to the external electronic device;

wherein the first and second implanted electronic devices are separably positionable and adapted for implantation in the proximity of the gastrointestinal system, and

wherein the external electronic device determines the status of the gastrointestinal tract based on the measurement transmitted from the second electronic device.

51. A device for use in detecting the volume and resistivity of material in a body cavity comprising:

a) a first pair of electronic devices adapted for implantation in the body comprising, including a first electronic device for generating an electrical current and a second electronic device configured to detect a potential field,

b) a second pair of electronic devices adapted for implantation in the body, including a third electronic device for generating an electromagnetic field and a fourth electronic device configured to detect an electromagnetic field,

c) an electronic device in communication with the second and fourth electronic devices for receiving a signal indicative of the strength of the potential field detected by the second electrical device, and for receiving a signal indicative of the strength of the electromagnetic field detected by the fourth electrical device, the electronic device using information received to infer the distance between the first and second electronic devices and the resistivity of the material.

52. A device for use in detecting the volume and resistivity of material in a body cavity comprising:

a) a plurality of electronic devices adapted for implantation in the body comprising at least a first electronic device and a second electronic device;

b) wherein one of the electronic devices is configured to generate an electrical current and the other electronic device is configured to detect a potential field; and

c) an external electronic device in communication with the plurality of electronic devices receiving signals indicative of the strength of the potential field and electromagnetic field detected, the external electronic device using information received to infer the distance between the plurality of electronic devices and the resistivity of the material.

53. The device of claim 52, wherein the first electronic device comprises a first capsule in communication with two electrodes and wherein the second electronic device comprises a capsule in communication with two electrodes.

54. The device of claim 52, wherein the electronic device further comprises a user interface for displaying the results of measurements to a user.

55. The device of claim 52, wherein the external electronic device further comprises a controller in communication with at least one of the plurality of electronic devices adapted for implantation in the body, whereby a signal from the controller causes the emission of an electrical current from at least one of the plurality of electronic devices adapted for implantation in the body, and wherein the electrical current stimulates peristaltic contractions.

56. A device for use in detecting the state of material in the body by measuring the electrical resistance of the material, comprising at least three electronic devices configured for implantation into the body, wherein:

a) a first electronic device is configured for generating an electrical current;

b) a second electronic device is configured for generating an electromagnetic field;

c) a third electronic device configured to detect a potential field and an electromagnetic field; and

d) an external electronic device in communication with the third electronic device for receiving a signal indicative of the strength of the potential field and electromagnetic field detected by the third electrical device, the external electronic device using information received to infer the distance between the electrical devices and the resistivity of the material.

57. A device for use in detecting the state of material in the body by measuring the electrical resistance of the material, comprising:

a) an external electronic device for generating control signals;

b) an inductive coil operably connected to the external electronic device for transmitting control signals;

c) a first electronic device adapted for implantation in the body including a first capsule having electronic circuitry in operable communication with a first antenna for detecting control signals, and the first capsule in communication with two electrodes for generating an electrical current; and

d) a second electronic device adapted for implantation in the body including a second capsule having electronic circuitry and in communication with two electrodes for detecting the magnitude of the electronic field emitted from the first electronic device, and a second antenna for transmitting signals to the inductive coil;

wherein the external electronic device computes an electrical resistance of the material between the first and second electronic devices from the signal detected at the second electronic device.

58. The device of claim 57, wherein the electromagnetic field is a radiofrequency field.

59. A device for use in detecting the state of material in the body by measuring the electrical resistance of the material, comprising:

a) an external electronic device for generating control signals;

b) an inductive coil operably connected to the external electronic device for transmitting control signals;

c) a first electronic device configured for implantation in the body including a first capsule having electronic circuitry in operable communication with a first antenna for detecting control signals, and the first electronic device emitting an electromagnetic field; and

d) a second electronic device configured for implantation in the body including a second capsule having electronic circuitry and detecting the magnitude of the electromagnetic field emitted from the first implanted electronic device, and a second antenna for transmitting signals to the inductive coil;

wherein the external electronic device computes the distention of the tissue between the first and second electronic devices from the signal detected at the second electronic device.

60. A method for use in detecting the state of material in a body cavity by measuring the electrical resistance comprising:

a) implanting a first and second electronic device, the first and second electronic devices configured for implantation into the body;

b) emitting electrical current from the first electronic device;

c) measuring the strength of the potential field at the second electronic device; and

d) transmitting the measurement recorded at the second microelectrical device to an external controller which uses information about the strength of the potential field to infer the state of material in the body cavity.

61. The device of claim 60, wherein first and second electronic devices are adapted for positioning by injection.

62. The method of claim 60, further including positioning the first electronic device on the opposite side of the bowel from the second electronic device.

63. The method of claim 60, further comprising implanting an electrical stimulator into the gastrointestinal tract of a patient;

and activating the electrical stimulator to elicit peristaltic contractions.

64. A method for measuring tissue distension, the method comprising:

a) separately implanting a first electronic device and a second electronic device at a distance from one another;

b) emitting an electromagnetic field from a first electronic device;

c) measuring the strength of the electromagnetic field at a second electronic device; and

d) transmitting a signal corresponding to strength of the electromagnetic field at a second electronic device to an external electronic controller, the electronic controller using the signal to infer the magnitude of tissue distention.

65. The device of claim 64, wherein first and second electronic devices are adapted for positioning by injection.

66. The method of claim 64, further including positioning the first electronic device on the opposite side of the bowel from the second electronic device.

67. The method of claim 64, further comprising implanting an electrical stimulator into the gastrointestinal tract of a patient;

and activating the electrical stimulator to elicit peristaltic contractions.

68. The method of claim 64, wherein the electromagnetic field is a radiofrequency field.