Incontinence treatment device

• US 7,387,603 B2
• Filed: 11/30/2004
• Issued: 06/17/2008
• 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: Lifschitz, David, Nissenkorn, Israel, Cohen, Ehud, Gross, Yossi
• Primary Examiner(s): Gilbert; Samuel G
• Application Number:
  US10/999,824
• Publication Number:
  US 20050113881A1
• Time in Patent Office: 1,295 Days
• Field of Search: 600/29, 600/30, 607/2, 607/39, 607/40, 607/48, 607/115, 607/116, 607/138
• 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. An apparatus comprising:

at least one elongated electrode structure comprising at least one electrode, the elongated electrode structure being adapted to sense an electromyographic signal indicative of urinary incontinence from a pelvic muscle of a patient; and

a control unit coupled to the at least one electrode and comprising an electrical waveform output that is adapted to be applied to the pelvic muscle through the at least one electrode, the control unit comprising a processor that analyzes the electromyographic signal and that controls the electrical waveform output as a function of the electromyographic signal to control the urinary incontinence; and

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

2. The apparatus according to claim 1, wherein the at least one elongated electrode structure is adapted to be implanted in the pelvic muscle.

3. The apparatus according to claim 1, wherein the at least one elongated electrode structure is adapted to be implanted in contact with a levator ani muscle portion of the pelvic muscle.

4. The apparatus according to claim 1, wherein the at least one elongated electrode structure is adapted to be implanted in contact with an urethral sphincter muscle portion of the pelvic muscle.

5. The apparatus according to claim 1, wherein the at least one elongated electrode structure is adapted to be implanted in contact with a portion of the pelvic muscle that is adjacent to an urethral sphincter muscle.

6. The apparatus according to claim 1, wherein the at least one elongated electrode structure is adapted to be implanted in a levator ani muscle portion of the pelvic muscle.

7. The apparatus according to claim 1, wherein the at least one elongated electrode structure is adapted to be implanted in an urethral sphincter muscle portion of the pelvic muscle.

8. The apparatus according to claim 1, wherein the at least one elongated electrode structure is adapted to be implanted in the a portion of the pelvic muscle that is adjacent to a urethral sphincter muscle.

9. The apparatus according to claim 1, wherein the electrical waveform output comprises a plurality of electrical pulses having pulse width durations in a range of 0.1 ms to 2 ms.

10. The apparatus according to claim 1, wherein the at least one electrode comprises a single unipolar electrode.

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

12. The apparatus according to claim 1, wherein the electrical waveform output comprises a biphasic electrical waveform.

13. The apparatus according to claim 1, wherein the control unit controls the electrical waveform output to treat urinary incontinence of the patient.

14. The apparatus according to claim 1, wherein the control unit controls the electrical waveform output to treat urinary urge incontinence.

15. The apparatus according to claim 1, wherein the control unit controls the electrical waveform output to treat urinary stress incontinence.

16. The apparatus according to claim 1, wherein the control unit comprises a pulse generator that actuates the electrical waveform output to terminate after a predetermined period of time.

17. The apparatus according to claim 16, wherein the pulse generator actuates the pulse generator to terminate after 5 seconds.

18. The apparatus according to claim 16, wherein the control unit controls the pulse generator to reapply the electrical waveform output to the muscle through the at least one electrode after termination of the application of the electrical waveform output.

19. The apparatus according to claim 1 wherein the control unit comprises a switch that is connected to the electrode and controlled by the control unit, and the switch disconnects the analyzing of the electromyographic signal when the electrical waveform output is provided.

20. 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.

21. 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.

22. 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 electromyographic signal is sensed.

23. The apparatus according to claim 22 wherein the control unit comprises a first-in first-out queue that receives an A/D output of the lower power A/D converter.

24. An apparatus comprising:

at least one elongated electrode structure comprising at least one electrode, the elongated electrode structure being adapted to sense an electromyographic signal indicative of urinary incontinence from a pelvic muscle of a patient; and

a control unit coupled to the at least one electrode and comprising an electrical waveform output that is adapted to be applied to the muscle through the at least one electrode, the control unit comprising a processor that analyzes the electromyographic signal and that controls the electrical waveform output as a function of the electromyographic signal to control the urinary incontinence; and

wherein the control unit controls the pulse width duration of the waveform to a range of pulse width durations that includes 2 ms.

25. The apparatus according to claim 24 wherein the control unit comprises a switch that is connected to the electrode and controlled by the control unit, and the switch disconnects the analyzing of the electromyographic signal when the electrical waveform output is provided.

26. The apparatus according to claim 24 wherein the control unit comprises an impedance sensor coupled to the electrode, and the impedance sensor measures tissue impedance.

27. The apparatus according to claim 24 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.

28. The apparatus according to claim 24 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 electromyographic signal is sensed.

29. The apparatus according to claim 28 wherein the control unit comprises a first-in first-out queue that receives an A/D output of the lower power A/D converter.

30. An apparatus comprising:

at least one elongated electrode structure comprising at least one electrode, the elongated electrode structure being adapted to sense an electromyographic signal indicative of urinary incontinence from a pelvic muscle of a patient; and

a control unit implanted in the patient and coupled to the at least one electrode structure and comprising an electrical waveform output comprising a plurality of electrical pulses that is applied to the pelvic muscle though the electrode structure the control unit comprising a processor that analyzes the electromyographic signal and that controls the electrical waveform output as a function of the electromyographic signal to control the urinary incontinence;

wherein the control unit includes a variable adaptive threshold level that increases as a function of an average of the electromyographic signal.

31. The apparatus according to claim 30 wherein the control unit comprises a switch that is connected to the electrode and controlled by the control unit, and the switch disconnects the analyzing of the electromyographic signal when the electrical waveform output is provided.

32. The apparatus according to claim 30 wherein the control unit comprises an impedance sensor coupled to the electrode, and the impedance sensor measures tissue impedance.

33. The apparatus according to claim 30 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.

34. The apparatus according to claim 30 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 electromyographic signal is sensed.

35. The apparatus according to claim 34 wherein the control unit comprises a first-in first-out queue that receives an A/D output of the lower power A/D converter.