Stimulator For The Control of a Bodily Function

• US 20090138061A1
• Filed: 01/16/2007
• Published: 05/28/2009
• Est. Priority Date: 01/16/2006
• Status: Abandoned Application

• Current Assignee: Continence Control Systems International Pty Ltd.
• Original Assignee: Continence Control Systems International Pty Limit
• Inventors: Bramich, Narelle, Laidlaw, Linda, Stephens, Anthony C.N.
• Application Number:
  US12/087,792
• Publication Number:
  US 20090138061A1
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37254 Pacemaker or defibrillator security, e.g. to prevent or inhibit programming alterations by hackers or unauthorised individuals
• CPC Class Codes: G16H 40/63 for local operation

Abstract

The present invention provides a device for the stimulation of smooth muscle tissue. The device includes a stimulator arranged to provide a signal to the smooth muscle tissue to control response of the smooth muscle tissue, and an interface arranged to allow programming of a controller of the stimulator. The interface may interact with an external controller. The device finds use in controlling smooth muscle tissue, such as a neosphincter, for the control of urinary or faecal incontinence in a patient.

Claims

1. A device for the stimulation of smooth muscle tissue, comprising a stimulator arranged to provide a signal to the smooth muscle tissue to control response of the smooth muscle tissue, and an interface arranged to allow programming of a controller of the stimulator.

2. A device in accordance with claim 1, wherein the signal is passed from the stimulator to the smooth muscle tissue via a stimulation lead.

3. A device in accordance with claim 2, wherein the stimulation lead has at least one electrode to deliver electrical stimulation to the smooth muscle tissue.

4. A device in accordance with any one of the preceding claims, wherein the smooth muscle tissue is one of a sphincter and a neosphincter.

5. A device in accordance with any one of the preceding claims wherein the signal delivered to the smooth muscle tissue is a symmetric or an asymmetric wave form.

6. A device in accordance with claim 5, wherein the wave form is a biphasic wave form.

7. A device in accordance with claim 6, wherein the stimulator is arranged to apply a delay between two phases of the biphasic wave form.

8. A device in accordance with claim 7, wherein the delay between the two phases is in the range from approximately 0 to 100 milliseconds.

9. A device in accordance with any one of the preceding claims, wherein the signal is an electric signal with a current amperage in the range of zero to twenty-five milliamps in each phase.

10. A device in accordance with claim 1, claim 2 or claim 3 wherein the impedance of the stimulation lead is in the range of approximately 300 ohms to 2000 ohms.

11. A device in accordance with any one of the preceding claims, wherein the device is implantable within a patient.

12. A device in accordance with any one of the preceding claims, further comprising at least one sensor.

13. A device in accordance with claim 12, wherein the sensor is arranged to monitor the response of the smooth muscle tissue.

14. A device in accordance with claim 12, wherein the at least one sensor is arranged to monitor the response of a bodily function of the patient.

15. A device in accordance with claim 14, wherein the bodily function is the fullness of the bladder of the patient.

16. A device in accordance with claim 14, wherein the bodily function is the fullness of the rectum of the patient.

17. A device in accordance with any one of claims 12 to 16, further comprising storage means arranged to store data collected from the at least one sensor.

18. A device in accordance with any one of the preceding claims, further including a power source in the form of an in-built battery.

19. A device in accordance with claim 17, wherein the battery is rechargeable.

20. A device in accordance with any one of claims 1 to 12, further including a power source in the form of a charge storing device.

21. A device in accordance with claim 20, wherein the charge storing device is a capacitor.

22. A device in accordance with any one of the preceding claims, further including a switch arranged to control stimulation of the device.

23. A device in accordance with claim 22, wherein the switch is a magnetic switch.

24. A device in accordance with claim 22, wherein the switch is a wireless communication device capable of sending an electromagnetic signal to the device.

25. A device in accordance with any one of the preceding claims, further comprising means to provide feedback on the status of the device.

26. A device in accordance with claim 25, wherein the feedback is provided by a tactile signal, such as a vibration.

27. A device in accordance with claim 25, wherein the feedback is provided by an audible signal.

28. A device in accordance with claim 25, wherein the feedback is provided by a visual signal.

29. A device in accordance with any one of claims 25 to 28, wherein the feedback includes information on the power status of the device.

30. A device in accordance with any one of claims 25 to 29, wherein the feedback includes information on the power level of the device.

44. A system for the stimulation of smooth muscle tissue, comprising a device in accordance with any one of claims 1 to 43 and an external controller arranged to communicate with the device.

45. A system in accordance with claim 44, wherein the external controller is arranged to program the stimulator controller.

46. A system in accordance with claim 44 or claim 45, wherein the external controller is arranged to upload data to a storage means.

47. A system in accordance with claim 44, claim 45 or claim 46, wherein the external controller is arranged to download data from a storage means.

50. A method of stimulating a smooth muscle tissue, comprising the steps of utilising a device in accordance with claim 1 to control the smooth muscle tissue, by applying a signal to the smooth muscle tissue to cause the smooth muscle tissue to contract.

51. A method for stimulating the pelvic floor, comprising the steps of utilising a device in accordance with claim 1 to stimulate the pelvic floor to cause the pelvic floor muscle to contract, thereby strengthening the pelvic floor.

52. A device in accordance with any one of claims 1 to 43, comprising a plurality of stimulators to stimulate a plurality of discrete smooth muscle neosphincters.

53. A device in accordance with claim 51, wherein the plurality of bodily functions includes at least one of the control of urine flow from the bladder and the control of stools and/or flatus from the rectum.

31. A device for the stimulation of smooth muscle tissue, comprising a stimulator arranged to provide a signal to the smooth muscle tissue to control response of the smooth muscle tissue, and means to provide feedback to a patient on the status of a controller for the stimulator.

32. A device in accordance with claim 31, wherein the feedback is provided via a tactile signal, such as a vibration.

33. A device in accordance with claim 31 or 32, wherein the feedback is provided by an audible signal.

34. A device in accordance with any one of claims 31 to 33, wherein the feedback is provided by a visual signal.

35. A device in accordance with any one of claims 31 to 34, wherein the feedback includes information on the power status of the device.

36. A device in accordance with any one of claims 31 to 35, wherein the feedback includes information on the power level of the device.

37. A device in accordance with any one of claims 31 to 36, wherein the feedback includes information on the fullness of the bladder or rectum.

38. A device for use with a stimulator arranged to provide a signal to smooth muscle tissue to control response of the smooth muscle tissue, the device comprising at least one sensor arranged to monitor a bodily function of a patient.

39. A device in accordance with claim 38, wherein the bodily function is the fullness of the bladder of the patient.

40. A device in accordance with claim 38, wherein the bodily function is the fullness of the rectum of the patient.

41. A device in accordance with claim 38, wherein the bodily function is the commencement and/or cessation of urination by the patient.

42. A device in accordance with claim 38, wherein the bodily function is the commencement and/or cessation of defecation by the patient.

43. A sensor arranged to provide feedback of a bodily function associated with one of a sphincter and a neosphincter.

48. A device for the stimulation of smooth muscle tissue, comprising a stimulator arranged to provide a signal arranged to stimulate the smooth muscle tissue, and a controller arranged to control the signal provided by the stimulator in a manner which influences the innervation of the smooth muscle tissue.

49. A method for calibrating a device for the stimulation of smooth muscle tissue, comprising the steps of measuring the impedance of a stimulation lead arranged to provide a stimulus signal to the smooth muscle tissue, measuring the response of the smooth muscle tissue, and, if necessary, adjusting the signal.