PELVIC DISORDER TREATMENT

• US 20090254145A1
• Filed: 06/17/2009
• Published: 10/08/2009
• Est. Priority Date: 10/06/1998
• Status: Active Grant

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Cohen, Ehud, Gross, Yossi, Lifschitz, David, Nissenkorn, Israel
• Granted Patent: US 8,083,663 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• CPC Class Codes: A61F 2/0036 implantable A61F2/0018 takes precedence
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

In a method of treating urinary incontinence, fecal incontinence, constipation and/or pathological retention of urine, at least one electrode of a lead is implanted in contact with a pelvic muscle of the patient. A proximal end of the lead is connected to a hermetically sealed implantable stimulator device configured to apply an electrical waveform through the at least one electrode. The electrical waveform is delivered from the stimulator device to the pelvic muscle through the lead and the at least one electrode. The electrical waveform provides at least partial relief from at least one of urinary incontinence, fecal incontinence, constipation and pathological urine retention.

Claims

1. A method for treating at least one of urinary incontinence, fecal incontinence, constipation and pathological retention of urine, comprising:

implanting at least one electrode of a lead in contact with a pelvic muscle of the patient;

connecting a proximal end of the lead to a hermetically sealed implantable stimulator device configured to apply an electrical waveform through the at least one electrode;

implanting the stimulator device within the patient; and

delivering the electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode;

wherein the electrical waveform provides at least partial relief from at least one of urinary incontinence, fecal incontinence, constipation and pathological urine retention.

2. The method of claim 1, wherein the at least one electrode comprises two or more electrodes.

3. The method of claim 1, wherein the lead comprises a fixation device comprising one of a spiral and hook, which is configured to anchor the lead to the pelvic muscle of the patient.

5. The method of claim 1, wherein the electrical waveform form comprises a biphasic electrical waveform.

6. The method of claim 1, wherein the at least one electrode is selected from the group consisting of an electrode formed from a wire, an electrode in the shape of a spiral and an electrode in the shape of a hook.

7. The method of claim 1, wherein the electrical waveform comprises electrical pulses having frequencies in a frequency range selected from the group consisting of 5-200 Hz, 20-50 Hz and 20-30 Hz.

8. The method of claim 1, wherein the electrical waveform comprises electrical pulses having a voltage amplitude in the range of 9-15 volts.

9. The method of claim 1, comprising treating urinary incontinence of the patient responsive to delivering the electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode.

10. The method of claim 1, comprising treating fecal incontinence of the patient responsive to delivering the electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode.

11. The method of claim 1, comprising treating constipation of the patient responsive to delivering the electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode.

12. The method of claim 1, comprising treating pathological urine retention of the patient responsive to delivering the electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode.

13. The method of claim 1, further comprising contracting the pelvic muscle responsive to delivering the electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode.

14. The method of claim 1, wherein the electrical waveform comprises a plurality of pulses each having a pulse width duration of 2 ms or less.

15. A method for treatment of urinary incontinence comprising:

providing a device comprising at least one electrode, a first processor and a second processor;

positioning the at least one electrode to cause contraction of a pelvic muscle of a patient responsive to application of electrical energy to the electrode;

processing signals indicative of a likelihood of imminent incontinence using the first processor at a low data analysis rate;

analyzing the signals at a high data analysis rate using the second processor responsive to a determination by the first processor that incontinence is imminent; and

applying an electrical waveform to the electrode that stimulates the muscle to contract, so as to inhibit the incontinence, responsive to the processing of the signals using the second processor.

16. The method of claim 15, further comprising storing the signals in a queue before analyzing the signals at a high data analysis rate using the second processor.