Electrode implantation in a pelvic floor muscular structure

• US 9,539,433 B1
• Filed: 03/18/2009
• Issued: 01/10/2017
• Est. Priority Date: 03/18/2009
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Inventors: Rehder, Peter, Wirbisky, Alan G., VanDeWeghe, Andrew P.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): MAHMOOD, NADIA AHMAD
• Application Number:
  US12/406,434
• Time in Patent Office: 2,855 Days
• Field of Search: 607/41, 607/40, 607/39, 607/116
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/38 for producing shock effects

Abstract

In a method of implanting an electrode of an electronic stimulator device into a pelvic floor muscular structure of a patient, a stimulation lead having a proximal end and a distal end comprising an electrode is provided. The distal end of the stimulation lead is fed along a path, which is adjacent the pubic symphysis of a patient, toward a pelvic floor muscular structure of the patient. The distal end of the stimulation lead is then fed into the pelvic floor muscular structure of the patient. In one embodiment, the pelvic floor muscular structure comprises the external urinary sphincter of the patient. In accordance with other embodiments, the pelvic floor muscular structure comprises one of the external anal sphincter, the levator ani muscle, the puborectalis sling muscle and prostate tissue.

Claims

1. A method comprising:

providing a stimulation lead having a proximal end and a distal end comprising an electrode;

feeding the distal end of the stimulation lead along a path, which is adjacent the pubic symphysis of a patient, toward a pelvic floor muscular structure of the patient; and

feeding the distal end of the stimulation lead into the pelvic floor muscular structure.

2. The method of claim 1, wherein the method further comprises:

making a first incision in the patient adjacent the notch in the posterior edge of the pubic symphysis; and

feeding the distal end of the stimulation lead from outside the patient'"'"'s body through the first incision and toward the ventral face of the pubic symphysis.

3. The method of claim 2, wherein feeding the distal end of the stimulation lead into the pelvic floor muscular structure comprises:

feeding the distal end of the stimulation lead toward the pelvic floor muscular structure;

piercing the perineal membrane; and

feeding the distal end of the stimulation lead into the pelvic floor muscular structure.

4. The method of claim 3, wherein the pelvic floor muscular structure comprises at least one of the group consisting of the external urinary sphincter muscle, the external anal sphincter muscle, the levator ani muscle, the puborectalis sling muscle and prostate tissue of the patient.

5. The method of claim 4, wherein feeding the distal end of the stimulation lead into the pelvic floor muscular structure comprises feeding the distal end into an insertion point of the external urinary sphincter at an angle that is approximately 0-45 degrees to a plane extending perpendicular to a central axis of the urethra and through the insertion point.

6. The method of claim 4, wherein feeding the distal end of the stimulation lead into the pelvic floor muscular structure comprises feeding the distal end into the external urinary sphincter along a line that does not intersect the urethra.

7. The method of claim 4, wherein feeding the distal end of the stimulation lead into the pelvic floor muscular structure comprises:

feeding a probe into the urethra of the patient and positioning the probe proximate a desired insertion point of the external urinary sphincter; and

feeding the distal end of the stimulation lead into the external urinary sphincter proximate the desired insertion point and the probe.

8. The method of claim 1, further comprising:

connecting the proximal end of the stimulation lead to a control unit;

generating electrical signals using the control unit; and

applying the electrical signals to the pelvic floor muscular structure through the electrode.

9. The method of claim 4, further comprising:

making a second incision in the abdomen of the patient, wherein the second incision is displaced from the first incision; and

feeding the proximal end of the lead through a subcutaneous tunnel between the first incision and second incisions, and out the second incision.

10. The method of claim 9, further comprising:

forming a subcutaneous pocket at the second incision;

connecting the proximal end of the stimulation lead to a control unit; and

implanting the control unit in the subcutaneous pocket.

11. The method of claim 9, further comprising:

making a third incision in the abdomen of the patient, wherein the third incision is displaced from the first and second incisions; and

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.

12. The method of claim 11, further comprising:

connecting the second end of the stimulation lead to a control unit;

generating electrical signals using the control unit; and

applying the electrical signals to the external urinary sphincter through the electrode.

13. The method of claim 12, 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.

14. The method of claim 1, wherein:

the patient is a male patient; and

feeding the distal end of the stimulation lead along a path comprises feeding the distal end of the stimulation lead between the ventral face of the pubic symphysis and the penis of the patient.

15. A method comprising:

providing a stimulation lead having a proximal end and a distal end comprising an electrode;

making a first incision in the patient;

feeding the distal end of the stimulation lead from outside the patient'"'"'s body through the first incision and alongside the ventral face of the pubic symphysis and toward the external urinary sphincter of the patient; and

feeding the distal end of the stimulation lead into an insertion point of the external urinary sphincter at an angle that is approximately 0-45 degrees to a plane extending perpendicular to a central axis of the urethra and through the insertion point.

16. The method of claim 15, wherein feeding the distal end of the stimulation lead into the external urinary sphincter comprises:

feeding the distal end of the stimulation lead toward the urinary sphincter;

piercing the perineal membrane; and

feeding the distal end of the stimulation lead into the external urinary sphincter.

17. The method of claim 15, wherein feeding the distal end of the stimulation lead into an insertion point of the external urinary sphincter comprises:

feeding a probe into the urethra of the patient and positioning the probe proximate the insertion point of the external urinary sphincter; and

feeding the distal end of the stimulation lead into the external urinary sphincter into the insertion point proximate the probe.

18. The method of claim 15, further comprising:

connecting the proximal end of the stimulation lead to a control unit;

generating electrical signals using the control unit; and

applying the electrical signals to the external urinary sphincter through the electrode.

19. The method of claim 18, further comprising:

making a second incision in the abdomen of the patient, wherein the second incision is displaced from the first incision; and

feeding the proximal end of the lead through a subcutaneous tunnel between the first incision and second incisions, and out the second incision.

20. The method of claim 19, further comprising:

forming a subcutaneous pocket at the second incision;

connecting the proximal end of the stimulation lead to a control unit; and

implanting the control unit in the subcutaneous pocket.