METHOD, SYSTEM AND DEVICE FOR TREATING DISORDERS OF THE PELVIC FLOOR BY ELECTRICAL STIMULATION OF THE SACRAL AND/OR PUDENDAL NERVES

• US 20080183236A1
• Filed: 03/31/2008
• Published: 07/31/2008
• Est. Priority Date: 09/06/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Granted Patent: US 9,272,140 B2
• Time in Patent Office: Days
• US Class Current: 607/39
• CPC Class Codes: A61N 1/0507 Electrodes for the digestive system
• CPC Class Codes: A61N 1/0521 Genital electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007

Abstract

Described are implantable devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of tissue volumes at two or more locations adjacent sacral nerves or portions thereof, and/or pudendal nerves or portions thereof. Two or more electrical stimulation regimes are applied on a continuous, alternating, intermittent or other basis to the respective tissue volumes in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary and/or fecal voiding dysfunctions such as constipation, incontinence disorders such as urge frequency and urinary retention disorders, sexual dysfunctions such as orgasmic and erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

Claims

1. A method of treating at least one pelvic floor disorder, the at least one disorder being selected from a group consisting of constipation, erectile dysfunction, prostatitis, prostatalgia and prostatodynia, the method comprising:

delivering electrical stimulation from a medical device implanted within a patient diagnosed with the pelvic floor disorder to a pudendal nerve or branches or portions thereof of the patient via at least one electrode of a lead implanted within the patient proximate to the pudendal nerve or branches or portions thereof; and

configuring the electrical stimulation to provide at least partial relief from the pelvic floor disorder.

2. The method of claim 1, further comprising diagnosing the patient as having the at least one pelvic floor disorder.

3. The method of claim 1,

wherein the lead comprises a first lead and the electrical stimulation comprises first electrical stimulation,

wherein the method further comprises:

delivering second electrical stimulation from the medical device to one of the pudendal nerve, another pudendal nerve, a sacral nerve, or branches or portions thereof of the patient via at least one electrode of a second lead implanted proximate to the pudendal nerve, another pudendal nerve, a sacral nerve, or branches or portions thereof; and

configuring a combination of the first and second electrical stimulation to provide at least partial relief from the pelvic floor disorder.

4. The method of claim 3, wherein delivering first electrical stimulation comprises delivering the first electrical stimulation to the pudendal nerve or branches or portions thereof on a first side of the patient, and delivering second electrical stimulation comprises delivering the second electrical stimulation to the other pudendal nerve on a second side of the patient.

5. The method of claim 3, wherein delivering second electrical stimulation comprises delivering the second electrical stimulation to the sacral nerve or branches or portions thereof.

6. The method of claim 5, wherein delivering the first electrical stimulation to the pudendal nerve or branches or portions thereof comprises delivering the first electrical stimulation to the pudendal nerve or branches or portions thereof on a first side of the patient, and delivering the second electrical stimulation to the sacral nerve or branches or portions thereof comprises delivering the second electrical stimulation to the sacral nerve or branches or portions thereof on a second side of the patient.

7. The method of claim 3, wherein delivering the first and second electrical stimulation comprises initiating delivery of the second electrical stimulation while the first electrical stimulation is already being delivered and in response to a sensed physical parameter or symptom.

8. The method of claim 1, wherein the at least one pelvic floor disorder comprises constipation.

9. The method of claim 1, wherein the at least one pelvic floor disorder comprises erectile dysfunction.

10. The method of claim 1, wherein the at least one pelvic floor disorder comprises prostatitis.

11. The method of claim 1, wherein the at least one pelvic floor disorder comprises prostatalgia.

12. The method of claim 1, wherein the at least one pelvic floor disorder comprises prostatodynia.

13. The method of claim 1, wherein the lead comprises a lead body less than about 1.5 mm in diameter.

14. The method of claim 1, wherein an inter-electrode distance of the lead is selected from the group consisting of about 1 mm, about 2 mm, about 3 mm, about 4 mm, and about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, and about 10 mm.

15. The method of claim 1, wherein the at least one electrode of the lead has an electrode surface area ranging between about 4.0 sq. mm and about 25 sq. mm.

16. The method of claim 1, wherein a distance between proximal and distal ends of at least one of the first lead and the second lead is selected from a group consisting of about 6 inches, about 8 inches, about 10 inches, about 12 inches, about 14 inches, about 16 inches about 18 inches, about 20 inches and more than about 20 inches.

17. The method of claim 1, wherein the electrical stimulation has a frequency ranging between about 50 Hz and about 100 Hz.

18. The method of claim 1, further comprising at least one of activating, modifying or terminating the electrical stimulation in response to a physical parameter or symptom being sensed.

19. The method of claim 18, further comprising sensing the physical parameter using a sensor selected from the group consisting of a nerve electrical signal sensor and an electromyographic sensor.

20. The method of claim 1, further comprising delivering a drug to the patient via a drug pump implanted within the patient.

21. A method of treating at least one pelvic floor disorder, the at least one disorder being selected from a group consisting of urinary voiding dysfunction, fecal voiding dysfunction, constipation, stress incontinence, urge incontinence, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia, the method comprising:

delivering first electrical stimulation from a medical device implanted within a patient diagnosed with the pelvic floor disorder to a first pudendal nerve or branches or portions thereof on a first side of the patient via at least one electrode of a first lead implanted within the patient proximate to the pudendal nerve or branches or portions thereof;

delivering second electrical stimulation from the medical device to a second pudendal nerve or branches or portions thereof on a second side of the patient via at least one electrode of a second lead implanted within the patient proximate to the second pudendal nerve or branches or portions thereof; and

configuring the first and second electrical stimulation to provide at least partial relief from the pelvic floor disorder.

22. A method of treating at least one pelvic floor disorder, the at least one disorder being selected from a group consisting of urinary voiding dysfunction, fecal voiding dysfunction, constipation, stress incontinence, urge incontinence, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia, the method comprising:

delivering first electrical stimulation from a medical device implanted within a patient diagnosed with the pelvic floor disorder to a pudendal nerve or branches or portions thereof via at least one electrode of a first lead implanted within the patient proximate to the pudendal nerve or branches or portions thereof;

delivering second electrical stimulation from the medical device to a sacral nerve or branches or portions thereof via at least one electrode of a second lead implanted within the patient proximate to the sacral nerve or branches or portions thereof; and

configuring the first and second electrical stimulation to provide at least partial relief from the pelvic floor disorder.

23. The method of claim 22,

wherein delivering first electrical stimulation to a pudendal nerve or branches or portions thereof comprises delivering the first electrical stimulation to the pudendal nerve or branches or portions thereof on a first side of the patient, and

wherein delivering second electrical stimulation to a sacral nerve or branches or portions thereof comprises delivering the second electrical stimulation to the sacral nerve or branches or portions thereof on a second side of the patient.