Pelvic disorder treatment device

• US 6,862,480 B2
• Filed: 11/29/2001
• Issued: 03/01/2005
• Est. Priority Date: 11/29/2001
• 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, Nissenkorn, Israel
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): SWEET, THOMAS
• Application Number:
  US09/996,668
• Publication Number:
  US 20030100930A1
• Time in Patent Office: 1,188 Days
• Field of Search: 128/898, 600/30, 607/41, 607/115, 607/116, 607/117, 607/118, 607/138, 607/40
• US Class Current: 607/41
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/204 Determining bladder volume
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/227 of constricting muscles, i.e. sphincters
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4047 afferent nerves, i.e. nerves that relay impulses to the central nervous system
• CPC Class Codes: A61B 5/6874 Bladder
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

A device for treating a medical condition is provided, and a surgical procedure for implanting the device is disclosed. The device includes a sensor, which is adapted to generate a signal responsive to a state of a patient, and at least one electrode, which is adapted to be coupled to a pelvic site of the patient. A control unit is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode. In various configurations, the device may be used alternatively or additionally to treat fecal incontinence, interstitial cystitis, chronic pelvic pain, or urine retention.

Claims

1. A method for implanting a medical device in a patient, comprising:

creating a suprapubic incision in the patient;

creating a vaginal mucosa incision in the patient;

passing between the two incisions an electrode lead which is adapted for coupling to the medical device; and

implanting the medical device in the patient,

wherein implanting the device comprises implanting a device which is capable of treating an interstitial cystitis condition of the patient.

2. A method according to claim 1, wherein passing the electrode lead comprises subcutaneously passing an inter-incision introducer between the two incisions, and passing the electrode lead through the introducer.

3. A method according to claim 1, and comprising:

removing the inter-incision introducer, so as to leave an end of the electrode lead accessible;

inserting a second introducer into the vaginal mucosa incision, such that a distal end of the second introducer is proximate a urethral sphincter site of the patient;

inserting the end of the electrode lead through the second introducer; and

securing the lead to the urethral sphincter site.

4. A method for implanting a medical device in a patient, comprising:

creating a suprapubic incision in the patient;

creating a vaginal mucosa incision in the patient;

passing between the two incisions an electrode lead which is adapted for coupling to the medical device, wherein passing the electrode lead comprises subcutaneously passing an inter-incision introducer between the two incisions, and passing the electrode lead through the introducer;

implanting the medical device in the patient;

removing the inter-incision introducer, so as to leave an end of the electrode lead accessible;

inserting a second introducer into the vaginal mucosa incision, such that a distal end of the second introducer is proximate a urethral sphincter site of the patient;

inserting the end of the electrode lead through the second introducer; and

securing the lead to the urethral sphincter site.

5. A method according to claim 4, wherein implanting the device comprises implanting a device which is capable of treating a stress incontinence condition of the patient.

6. A method according to claim 4, wherein implanting the device comprises implanting a device which is capable of treating an urge incontinence condition of the patient.

7. A method according to claim 4, wherein implanting the device comprises implanting a device which is capable of treating an urge frequency condition of the patient.

8. A method according to claim 4, wherein implanting the device comprises implanting a device which is capable of treating a fecal incontinence condition of the patient.

9. A method according to claim 4, wherein implanting the device comprises implanting a device which is capable of treating a chronic pelvic pain condition of the patient.

10. A method according to claim 4, wherein implanting the device comprises implanting a device which is capable of treating a urine retention condition of the patient.

11. A method according to claim 4, wherein passing the electrode lead comprises subcutaneously passing an inter-incision introducer between the two incisions, and passing the electrode lead through the introducer.