Incontinence treatment device

• US 8,340,786 B2
• Filed: 06/12/2008
• Issued: 12/25/2012
• Est. Priority Date: 10/06/1998
• Status: Expired due to Fees

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Gross, Yossi, Cohen, Ehud, Nissenkorn, Israel, Lifschitz, David
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): LEE, ERICA SHENGKAI
• Application Number:
  US12/138,031
• Publication Number:
  US 20080242918A1
• Time in Patent Office: 1,657 Days
• Field of Search: 607/16, 607/28, 607 40- 41, 607/74, 607/116, 607/138, 607 70- 72, 607/115, 600/30, 600/546, 600/29, 330/98, 330/310
• US Class Current: 607/138
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence
• CPC Class Codes: A61B 5/391 of genito-urinary organs
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/378 Electrical supply

Abstract

An apparatus for treatment of fecal incontinence comprises at least one electrode placed in contact with a pelvic muscle of a patient and a control unit that is coupled to the electrode. The at least one electrode comprises a flexible intra-muscular electrode that conducts electromyographic (EMG) signals from the muscle. The control unit comprises a processor that analyzes the EMG signals conducted through the at least one electrode, determines whether the EMG signals are indicative of fecal incontinence and, responsive to the signal being indicative of fecal incontinence, applies an electrical waveform to the muscle through the at least one electrode.

Claims

1. An apparatus for treatment of fecal incontinence of a patient comprising:

at least one electrode implantable in a pelvic muscle of the patient, the at least one electrode conducts electromyographic (EMG) signals from the muscle; and

a control unit implantable in the patient coupled to the at least one electrode comprising a processor configured to analyze the EMG signals conducted through the at least one electrode, determines whether the EMG signals are indicative of fecal incontinence and, responsive to the signals being indicative of fecal incontinence, applies an electrical waveform to the muscle through the at least one electrode;

wherein the at least one electrode comprises a flexible intra-muscular electrode.

2. The apparatus of claim 1, wherein the electrical waveform comprises a plurality of pulses each having a pulse width duration within a range that includes 2 ms.

3. The apparatus of claim 1, wherein the electrical waveform comprises a plurality of pulses each having a pulse width duration within a range that includes 0.1 ms to 2ms.

4. The apparatus of claim 1, wherein the at least one electrode comprises a single unipolar electrode.

5. The apparatus of claim 1, wherein the at least one electrode comprises a pair of bipolar electrodes.

6. The apparatus of claim 1, wherein the electrical waveform comprises a biphasic electrical waveform.

7. The apparatus of claim 1, wherein the control unit terminates the electrical waveform after a predetermined period of time.

8. The apparatus of claim 1, wherein the control unit comprises a switch that disconnects an electrical connection between the at least one electrode and the control unit before the control unit applies the electrical waveform to the muscle through the at least one electrode.

9. The apparatus according to claim 1, wherein the control unit comprises an impedance sensor coupled to the electrode, and the impedance sensor measures tissue impedance.

10. The apparatus according to claim 1, wherein:

the control unit comprises a differential preamplifier with a preamplifier input that is coupled to the electrode and a preamplifier output; and

wherein the control unit further comprises an amplifier with an amplifier input that receives the preamplifier output.

11. The apparatus according to claim 1, wherein the control unit comprises a lower power A/D converter that analyzes continuously at a lower sampling rate, and a higher power A/D converter that analyzes at a higher rate when the EMG signal is sensed.

12. The apparatus according to claim 1, wherein:

the processor is a first processor that analyzes the EMG signals substantially continuously at a low data analysis rate;

the apparatus comprising a second processor that analyzes the EMG signals at a high data analysis rate responsive to the first processor determining that the EMG signals are indicative of fecal incontinence; and

the controller applies the electrical waveform to the muscle through the at least one electrode responsive to the analysis of the EMG signals at the high data analysis rate.

13. An electronic muscle stimulator device comprising:

at least one electrode configured for implantation into a muscle of a patient; and

a control unit coupled to the at least one electrode and configured to apply an electrical waveform to the at least one electrode, wherein the control unit comprises a switch that disconnects an electrical connection between the at least one electrode and the control unit before the control unit applies the electrical waveform to the at least one electrode;

wherein the control unit includes a processor that analyzes electromyographic (EMG) signals received through the at least one electrode, determines whether the EMG signals are indicative of fecal incontinence, and, responsive to the signals being indicative of fecal incontinence, applies the electrical waveform to the muscle through the at least one electrode after disconnecting the electrical connection.

14. A method of treating a patient comprising:

implanting at least one electrode in a pelvic muscle of the patient, wherein the at least one electrode comprises a flexible intra-muscular electrode;

conducting electromyographic (EMG) signals from the muscle to a control unit through the at least one electrode;

determining whether the EMG signals are indicative of fecal incontinence; and

applying an electrical waveform to the muscle through the at least one electrode responsive to determining that the signals are indicative of fecal incontinence.

15. The method of claim 14, wherein applying an electrical waveform to the muscle through the at least one electrode comprises applying an electrical waveform comprising a plurality of pulses each having a pulse width duration within a range that includes 2 ms to the muscle through the at least one electrode.

16. The method of claim 14, wherein applying an electrical waveform to the muscle through the at least one electrode comprises applying a biphasic electrical waveform to the muscle through the at least one electrode.

17. The method of claim 14, comprising disconnecting an electrical connection between the at least one electrode and the control unit before applying the electrical waveform to the muscle.

18. The method of claim 14, wherein determining whether the EMG signals are indicative of fecal incontinence comprises:

analyzing the EMG signals at a first data rate;

determining that the EMG signals are indicative of fecal incontinence based on the analysis at the first data rate; and

analyzing the EMG signals at a second data rate responsive to determining that the EMG signals are indicative of fecal incontinence.