IP Library Granted Patent US 7,647,113
Granted Patent B2
US 7,647,113 · App. 11/961,615 · Granted Jan 12, 2010

Electrode implantation in male external urinary sphincter

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Quick Facts
Patent No.
US 7,647,113
App. No.
11/961,615
Granted
Jan 12, 2010
Kind
B2
Abstract

In a method of implanting an electrode of an electronic stimulator device into an external urinary sphincter of a male patient, a first incision is made in the perineum of the patient between the anus and the scrotal-perineal junction. A distal end of a stimulation lead is then fed through the first incision, through the perineal membrane and into the external urinary sphincter. The distal end includes the electrode. In one embodiment of the method, a second incision is made in the abdomen of the patient. In one embodiment, the second incision is made lateral to and cephalad to the pubis bone of the patient. Next, a proximal end of the stimulation lead is fed from the first incision to the second incision. In one embodiment, the proximal end of the stimulation lead is coupled to a control unit of the electronic stimulator device. Electrical signals are generated using the control unit and the electrical signals are delivered to the external urinary sphincter through the stimulation lead and the electrode.

Claims (89)

1. A method of implanting an electrode of an electronic stimulator device into an external urinary sphincter of a male patient, the method comprising:

making a first incision in the perineum between the anus and the scrotal-perineal junction; and

feeding a distal end of a stimulation lead through the first incision, through the perineal membrane and into the external urinary sphincter, the distal end comprising the electrode.

2. The method of claim 1 , wherein feeding a distal end of a stimulation lead through the first incision, through the perineal membrane and into the external urinary sphincter comprises:

installing a first tube having a first end proximate the first incision and a second end that extends through the perineal membrane and into the external urinary sphincter; and

feeding the distal end of the stimulation lead through the first tube, out the second end of the first tube and in contact with the external urinary sphincter.

3. The method of claim 2 , wherein installing a first tube having a first end proximate the first incision and a second end that extends through the perineal membrane and into the external urinary sphincter comprises:

providing a first introducer comprising a needle guide within the first tube;

tunneling from the first incision through the perineum and into the external urinary sphincter using the needle guide; and

removing the needle guide from the first tube.

4. The method of claim 3 , further comprising:

making a second incision in the abdomen of the patient;

installing a second tube having a first end proximate the first incision and a second end proximate the second incision;

attaching a proximal end of the stimulation lead to the first end of the second tube; and

pulling the second tube and the proximal end of the stimulation lead out of the second incision.

5. The method of claim 4 , further comprising:

coupling the proximal end of the stimulation lead to a control unit of the electronic stimulator device;

generating electrical signals using the control unit; and

delivering the electrical signals to the external urinary sphincter through the stimulation lead and the electrode.

6. The method of claim 5 , further comprising:

forming a subcutaneous pocket at the second incision; and

implanting the control unit in the subcutaneous pocket.

7. The method of claim 5 , wherein the electrical signals are configured to treat a pelvic condition selected from the group consisting of pelvic pain and urinary incontinence.

8. The method of claim 4 , further comprising:

making a third incision that is displaced from the second incision;

coupling a first end of an extension lead to the proximal end of the stimulation lead; and

feeding a second end of the extension lead through a subcutaneous tunnel between the second incision and the third incision and out the third incision.

9. The method of claim 8 , wherein feeding a second end of the extension lead through a subcutaneous tunnel between the second incision and the third incision and out the third incision comprises:

installing a third tube in the subcutaneous tunnel having a first end proximate the third incision and a second end proximate the second incision;

attaching a second end of the extension lead to the second end of the third tube; and

pulling the third tube and the second end of the extension lead through the subcutaneous tunnel and out of the third incision.

10. The method of claim 8 , further comprising:

coupling the second end of the extension lead to a control unit of the electronic stimulator device;

generating electrical signals using the control unit; and

delivering the electrical signals to the external urinary sphincter through the extension lead, the stimulation lead and the electrode.

11. The method of claim 10 , further comprising:

disconnecting the second end of the extension lead from the control unit;

disconnecting the first end of the extension lead from the proximal end of the stimulation lead;

removing the extension lead from the subcutaneous tunnel;

coupling the proximal end of the stimulation lead to the control unit;

generating electrical signals using the control unit; and

delivering the electrical signals to the external urinary sphincter through the stimulation lead and the electrode.

12. The method of claim 11 , further comprising:

forming a subcutaneous pocket at the second incision; and

implanting the control unit in the subcutaneous pocket.

13. The method of claim 11 , wherein the electrical signals are configured to treat a pelvic condition selected from the group consisting of pelvic pain and urinary incontinence.

14. The method of claim 8 , wherein the second incision is located lateral to and cephalad to the pubis bone of the patient.

15. The method of claim 2 , further comprising:

anchoring the distal end of the stimulation lead to the external urinary sphincter; and

removing the first tube while the distal end of the stimulation lead remains anchored to the external urinary sphincter.

16. A method of implanting an electrode of an electronic stimulator device into an external urinary sphincter of a male patient, the method comprising:

making a first incision in the perineum between the anus and the scrotal-perineal junction;

feeding a distal end of a stimulation lead through the first incision, through the perineal membrane and into the external urinary sphincter, the distal end comprising the electrode;

making a second incision in the abdomen of the patient; and

feeding a proximal end of the stimulation lead from the first incision to the second incision.

17. The method of claim 16 , wherein feeding a distal end of a stimulation lead through the first incision, through the perineal membrane and into the external urinary sphincter comprises:

installing a first tube having a first end proximate the first incision and a second end that extends through the perineal membrane and into the external urinary sphincter; and

feeding the distal end of the stimulation lead through the first tube, out the second end of the first tube and in contact with the external urinary sphincter.

18. The method of claim 17 , wherein installing a first tube having a first end proximate the first incision and a second end that extends through the perineal membrane and into the external urinary sphincter comprises:

providing a first introducer comprising a needle guide within the first tube;

tunneling from the first incision through the perineum and into the external urinary sphincter using the needle guide; and

removing the needle guide from the first tube.

19. The method of claim 17 , wherein feeding a proximal end of the stimulation lead from the first incision to the second incision comprises:

installing a second tube having a first end proximate the first incision and a second end proximate the second incision;

attaching a proximal end of the stimulation lead to the first end of the second tube; and

pulling the second tube and the proximal end of the stimulation lead out of the second incision.

20. The method of claim 16 , further comprising:

coupling a proximal end of the stimulation lead to a control unit of the electronic stimulator device;

generating electrical signals using the control unit; and

delivering the electrical signals to the external urinary sphincter through the stimulation lead and the electrode.

21. The method of claim 20 , further comprising:

forming a subcutaneous pocket at the second incision; and

implanting the control unit in the subcutaneous pocket.

22. The method of claim 20 , wherein the electrical signals are configured to treat a pelvic condition selected from the group consisting of pelvic pain and urinary incontinence.

23. The method of claim 16 , further comprising:

making a third incision that is displaced from the second incision;

coupling a first end of an extension lead to the proximal end of the stimulation lead; and

feeding a second end of the extension lead through a subcutaneous tunnel between the second incision and the third incision and out the third incision.

24. The method of claim 21 , further comprising:

coupling the second end of the extension lead to a control unit of the electronic stimulator device;

generating electrical signals using the control unit; and

delivering the electrical signals to the external urinary sphincter through the extension lead, the stimulation lead and the electrode.

25. The method of claim 24 , further comprising:

disconnecting the second end of the extension lead from the control unit;

disconnecting the first end of the extension lead from the proximal end of the stimulation lead;

removing the extension lead from the subcutaneous tunnel;

coupling the proximal end of the stimulation lead to the control unit;

generating electrical signals using the control unit; and

delivering the electrical signals to the external urinary sphincter through the stimulation lead and the electrode.

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 24, 2016
From: AMERICAN MEDICAL SYSTEMS, LLC
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 037901/0883 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 24, 2016
From: AMS RESEARCH, LLC
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 037901/0941 →
RELEASE OF SECURITY INTEREST Recorded Aug 6, 2015
From: DEUTSCHE BANK AG NEW YORK BRANCH
To: AMERICAN MEDICAL SYSTEMS, LLC; AMS RESEARCH, LLC; LASERSCOPE
Reel/Frame 036285/0146 →
GRANT OF SECURITY INTEREST IN PATENTS Recorded Mar 20, 2014
From: ENDO PHARMACEUTICALS SOLUTIONS, INC.; ENDO PHARMACEUTICALS, INC.; AMS RESEARCH CORPORATION; AMERICAN MEDICAL SYSTEMS, INC.; LASERSCOPE
To: DEUTSCHE BANK AG NEW YORK BRANCH, AS COLLATERAL AGENT
Reel/Frame 032491/0440 →
RELEASE OF PATENT SECURITY INTEREST Recorded Mar 3, 2014
From: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
To: AMS RESEARCH CORPORATION
Reel/Frame 032380/0053 →
SECURITY AGREEMENT Recorded Jul 22, 2011
From: AMS RESEARCH CORPORATION
To: MORGAN STANLEY SENIOR FUNDING, INC., AS ADMINISTRATIVE AGENT
Reel/Frame 026632/0535 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 21, 2007
From: WIRBISKY, ALAN G.; VANDEWEGHE, ANDREW P.
To: AMS RESEARCH CORPORATION
Reel/Frame 020412/0186 →