Pelvic disorder treatment device

• US 7,613,516 B2
• Filed: 11/28/2002
• Issued: 11/03/2009
• Est. Priority Date: 11/29/2001
• Status: Active Grant

• Current Assignee: ENDO USA Incorporated
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Cohen, Ehud, Gross, Yossi, Nissenkorn, Israel
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US10/497,397
• Publication Number:
  US 20050216069A1
• Time in Patent Office: 2,532 Days
• Field of Search: 607/40, 607/41
• US Class Current: 607/41
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/204 Determining bladder volume
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/227 of constricting muscles, i.e. sphincters
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/6874 Bladder
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A device (20) for treating a medical condition is provided, and a surgical procedure for implanting the device is disclosed. The device (20) includes a sensor (44), which is adapted to generate a signal responsive to a state of a patient, and at least one electrode (27), which is adapted to be coupled to a pelvic site of the patient. A control unit (22) is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode (27). In various configurations, the device (20) may be used alternatively or additionally to treat fecal incontinence, interstitial cystitis, chronic pelvic pain, or urine retention.

Claims

1. A device, comprising:

at least one electrode, which is adapted to be coupled to a pelvic muscle of a patient; and

a control unit, which is adapted to drive the at least one electrode to apply to the muscle an electrical waveform configured to treat a neurogenic bladder condition of the patient responsive to an amount of time elapsed since the patient last voided his or her bladder.

3. A device according to claim 1, wherein the control unit is adapted to receive an input from the patient and to apply the waveform responsive to the input.

4. A device according to claim 1, wherein the at least one electrode comprises a single monopolar electrode.

5. A device according to claim 1, wherein the at least one electrode comprises a pair of bipolar electrodes.

6. A device according to claim 1, wherein the at least one electrode comprises a flexible intra-muscular electrode.

7. A device according to claim 1, wherein the at least one electrode and the control unit are adapted to be implanted in the body of the patient.

8. A device according to claim 1, wherein the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient.

9. A device according to claim 8, wherein the control unit is adapted to configure the waveform to have a frequency component between about 5 and 15 Hz.

10. A device according to claim 8, wherein the control unit is adapted to configure the waveform to have an amplitude between about 1 and 4 V.

11. A device according to claim 8, wherein the control unit is adapted to configure the waveform to include a series of pulses having widths between about 0.05 and 0.2 ms.

12. A device according to claim 8, wherein the control unit is adapted to configure the waveform to have a duration of about 10-30 minutes.

13. A device according to claim 8, wherein the control unit is adapted to configure the waveform to include a rise time lasting between about 1 second and 3 minutes prior to attaining a designated waveform application voltage.

14. A device according to claim 8, wherein the control unit is adapted to configure the waveform to include a decay time lasting between about 1 second and 3 minutes, prior to returning to a baseline voltage.

15. A device according to claim 8, wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

16. A device according to claim 8, wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

2. A device, comprising:

at least one electrode, which is adapted to be coupled to a pelvic muscle of a patient; and

a control unit, which is adapted to drive the at least one electrode to apply to the muscle an electrical waveform configured to treat an urgency frequency symptom of the patient responsive to an amount of time elapsed since the patient last voided his or her bladder.

17. A device according to claim 2, wherein the control unit is adapted to receive an input from the patient and to apply the waveform responsive to the input.

18. A device according to claim 2, wherein the at least one electrode comprises a single monopolar electrode.

19. A device according to claim 2, wherein the at least one electrode comprises a pair of bipolar electrodes.

20. A device according to claim 2, wherein the at least one electrode comprises a flexible intra-muscular electrode.

21. A device according to claim 2, wherein the at least one electrode and the control unit are adapted to be implanted in the body of the patient.

22. A device according to claim 2, wherein the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle of the patient.

23. A device according to claim 22, wherein the control unit is adapted to configure the waveform to have a frequency component between about 5 and 15 Hz.

24. A device according to claim 22, wherein the control unit is adapted to configure the waveform to have an amplitude between about 1 and 4 V.

25. A device according to claim 22, wherein the control unit is adapted to configure the waveform to include a series of pulses having widths between about 0.05 and 0.2 ms.

26. A device according to claim 22, wherein the control unit is adapted to configure the waveform to have a duration of about 10-30 minutes.

27. A device according to claim 22, wherein the control unit is adapted to configure the waveform to include a rise time lasting between about 1 second and 3 minutes prior to attaining a designated waveform application voltage.

28. A device according to claim 22, wherein the control unit is adapted to configure the waveform to include a decay time lasting between about 1 second and 3 minutes, prior to returning to a baseline voltage.

29. A device according to claim 22, wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

30. A device according to claim 22, wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

31. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to a pelvic site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode,

wherein the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle responsive to analyzing the signal and determining that an urge event is imminent, and

wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

32. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to a pelvic site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode,

wherein the control unit is adapted to configure the waveform so as to induce relaxation of a bladder muscle responsive to analyzing the signal and determining that an urge event is imminent, and

wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

33. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to an anatomical site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to determine a likelihood of imminent patient pain due to interstitial cystitis, and, responsive to analyzing the signal, to apply to the at least one electrode an electrical waveform configured to reduce patient pain due to interstitial cystitis,

wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

34. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to an anatomical site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to determine a likelihood of imminent patient pain due to interstitial cystitis, and, responsive to analyzing the signal, to apply to the at least one electrode an electrical waveform configured to reduce patient pain due to interstitial cystitis,

wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.

35. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to an anatomical site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to determine a likelihood of patient pelvic pain, and, responsive to analyzing the signal, to apply to the at least one electrode an electrical waveform configured to reduce the patient pelvic pain,

wherein the control unit is adapted to configure the waveform to have a duty cycle between about 6% and about 50%.

36. A device, comprising:

a sensor, which is adapted to generate a signal responsive to a state of a patient;

at least one electrode, which is adapted to be coupled to an anatomical site of the patient; and

a control unit, which is adapted to receive the signal, to analyze the signal so as to determine a likelihood of patient pelvic pain, and, responsive to analyzing the signal, to apply to the at least one electrode an electrical waveform configured to reduce the patient pelvic pain,

wherein the control unit is adapted to configure the waveform to have a duty cycle of between about 2 and about 10 seconds on, and between about 10 and about 30 seconds off.