Mechanical and electrical sensing for incontinence treatment

• US 6,896,651 B2
• Filed: 01/15/2002
• Issued: 05/24/2005
• Est. Priority Date: 10/06/1998
• Status: Expired due to Term

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: BioControl Medical (B.C.M) Ltd.
• Inventors: Cohen, Ehud, Gross, Yossi, Lifschitz, David, Nissenkorn, Israel
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US10/047,135
• Publication Number:
  US 20020062060A1
• Time in Patent Office: 1,225 Days
• Field of Search: 600/29, 600/30, 600/549, 600/551, 600/591, 128/DIG.25, 607/138, 607/70, 607/72, 607/41, 607/71, 607/61
• US Class Current: 600/30
• 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

A device and method for treatment of urinary stress incontinence. At least one electrode is implanted in a pelvic muscle of a patient. A control unit receives signals indicative of abdominal stress in the patient and responsive thereto applies an electrical waveform to the electrode which stimulates the muscle to contract, so as to inhibit involuntary urine flow through the patient'"'"'s urethra due to the stress.

Claims

1. A device for treatment of urinary stress incontinence, comprising:

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

a control unit, which receives signals indicative of abdominal pressure or strain in the patient and further comprises a processor which analyzes the signals and determines when an involuntary urine flow is likely, and when the analyzed signals exceed a predetermined threshold indicative of abdominal pressure or strain, applies an electrical waveform to the electrode which stimulates the muscle to contract, so as to inhibit involuntary urine flow through the patient'"'"'s urethra due to stress.

2. A device according to claim 1, wherein the signals comprise electromyographic signals received from the at least one electrode.

3. A device according to claim 1, wherein the processor is programmable to vary one or more parameters associated with the application of the waveform.

4. A device according to claim 3, and comprising a wireless receiver, which receives data for programming the processor from a programming unit outside the patient'"'"'s body.

5. 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, and wherein the control unit comprises a rechargeable power source.

6. A device according to claim 5, wherein the power source is recharged by inductive energy transfer, substantially without electrical contact between the control unit and any object outside the patient'"'"'s body.

7. A device according to claim 1, wherein the pelvic muscle comprises the levator ani muscle.

8. A device according to claim 1, wherein the pelvic muscle comprises the urethral sphincter muscle.

9. A device according to claim 1, wherein the pelvic muscle is adjacent to the urethral sphincter muscle.

10. A method for treatment of urinary stress incontinence of a patient, comprising:

implanting an electrode in a pelvic muscle of the patient;

receiving a signal from the patient'"'"'s body indicative of abdominal pressure or strain;

analyzing the received signal using a processor; and

responsive to the analyzed signal, applying an electrical waveform to the electrode, which stimulates the muscle to contract so as to inhibit involuntary urine flow.

11. A method according to 10, wherein the pelvic muscle comprises the levator ani muscle.

12. A method according to claim 10, wherein the pelvic muscle comprises the urethral sphincter muscle.

13. A method according to claim 10, wherein implanting the electrode comprises implanting an electrode in proximity to the urethral sphincter muscle.

14. A method according to claim 10, wherein receiving the signal comprises receiving an electromyographic signal.

15. A device for inhibiting involuntary urine flow, comprising:

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

sensor, which senses a change in pressure of an abdomen or a urinary bladder of the patient and generates a signal responsive thereto; and

a control unit, which receives the signal, analyzes the signal to determine a level of abdominal stress of the patient, and, responsive thereto, applies an electrical waveform to the electrode which stimulates the muscle to contract and inhibit involuntary urine flow through the patient'"'"'s urethra due to stress,

wherein the control unit comprises a processor which analyzes the signals and determines when an involuntary urine flow is likely, whereupon the waveform is applied, and

wherein the processor is programmable to vary one or more parameters associated with the application of the waveform.

16. A device according to claim 15, and comprising a wireless receiver, which is adapted to receive data for programming the processor from a programming unit outside the patient'"'"'s body.

17. A method for inhibiting involuntary urine flow of a patient, comprising:

implanting an electrode in a pelvic muscle of the patient;

receiving a pressure-measurement signal indicative of abdominal stress; and

responsive to the signal, applying an electrical waveform to the electrode, which stimulates the muscle to contract so as to inhibit involuntary urine flow.

18. A method according to 17, wherein implanting the electrode in the pelvic muscle comprises implanting the electrode in the levator ani muscle.

19. A method according to claim 17, wherein implanting the electrode in the pelvic muscle comprises implanting the electrode in the urethral sphincter muscle.

20. A method according to claim 17, wherein implanting the electrode comprises implanting the electrode in proximity to the urethral sphincter muscle.

21. A method according to claim 17, wherein applying the waveform comprises applying the waveform responsive to an electromyographic signal.

22. A method for inhibiting involuntary urine flow of a patient, comprising:

implanting an electrode in a pelvic muscle of the patient;

receiving a strain-measurement signal indicative of abdominal stress; and

responsive to the signal, applying an electrical waveform to the electrode, which stimulates the muscle to contract so as to inhibit involuntary urine flow.

23. A method according to 22, wherein implanting the electrode in the pelvic muscle comprises implanting the electrode in the levator ani muscle.

24. A method according to claim 22, wherein implanting the electrode in the pelvic muscle comprises implanting the electrode in the urethral sphincter muscle.

25. A method according to claim 22, wherein implanting the electrode comprises implanting the electrode in proximity to the urethral sphincter muscle.

26. A method according to claim 22, wherein applying the waveform comprises applying the waveform responsive to an electromyographic signal.