Pelvic disorder treatment

• US 8,083,663 B2
• Filed: 06/17/2009
• Issued: 12/27/2011
• 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): Lacyk, John P
• Application Number:
  US12/486,492
• Publication Number:
  US 20090254145A1
• Time in Patent Office: 923 Days
• Field of Search: 600 29- 32, 600/549, 600/551, 600/591, 128/DIG.25, 607 70- 72, 607/61, 607/41, 607/138
• US Class Current: 600/30
• 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 comprising:

providing a lead comprising at least one electrode;

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

connecting a proximal end of the lead to a hermetically sealed implantable stimulator device;

implanting the stimulator device within the patient; and

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

treating a condition of the patient responsive to delivering the electrical waveform, wherein the condition of the patient is selected from the group consisting of fecal incontinence and pathological urine retention.

2. The method of claim 1, wherein providing a lead comprising at least one electrode comprises providing a lead comprising two or more electrodes.

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

4. The method of claim 1, wherein delivering an electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode comprises delivering a biphasic electrical waveform to the pelvic muscle through the lead and the at least one electrode.

5. The method of claim 1, wherein providing a lead comprising at least one electrode comprises providing a lead comprising 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.

6. The method of claim 1, wherein delivering an electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode comprises delivering an electrical waveform comprising electrical pulses having a frequency range of 5-200 Hz.

7. The method of claim 1, wherein delivering an electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode comprises delivering an electrical waveform comprising electrical pulses having a voltage amplitude in the range of 9-15 volts.

8. The method of claim 1, wherein treating a condition of the patient responsive to delivering the electrical waveform comprises treating fecal incontinence of the patient responsive to delivering the electrical waveform.

9. The method of claim 1, wherein treating a condition of the patient responsive to delivering the electrical waveform comprises treating pathological urine retention of the patient responsive to delivering the electrical waveform.

10. The method of claim 1, further comprising contracting the pelvic muscle responsive to delivering the electrical waveform from.

11. The method of claim 1, wherein delivering an electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode comprises delivering an electrical waveform comprising a plurality of pulses each having a pulse width duration of 2 ms or less.

14. The method of claim 1, wherein delivering an electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode comprises delivering an electrical waveform comprising electrical pulses having a frequency range of 20-50 Hz.

15. The method of claim 1, wherein delivering an electrical waveform from the stimulator device to the pelvic muscle through the lead and the at least one electrode comprises delivering an electrical waveform comprising electrical pulses having a frequency range of 20-30 Hz.

12. 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;

sensing signals selected from the group consisting of electromyogram (EMG) signals from the patient and signals representative of a physiological parameter of the patient;

processing the signals using the first processor at a first data analysis rate;

determining that the signals are indicative of a imminent urinary incontinence based upon processing the signals;

analyzing the signals at a second data analysis rate using the second processor responsive to determining that the signals are indicative of a imminent urinary incontinence, wherein the second data analysis rate is higher than the first data analysis rate; and

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

13. The method of claim 12, further comprising storing the signals in a queue before analyzing the signals at a second data analysis rate.