Method, system and device for treating disorders of the pelvic floor by means of electrical stimulation of the pudendal and associated nerves, and the optional delivery of drugs in association therewith

• US 7,328,068 B2
• Filed: 11/26/2003
• Issued: 02/05/2008
• Est. Priority Date: 03/31/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Malaguti, Sylvia, Giardiello, Gianluca, Spinelli, Michele, Gerber, Martin T.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/723,316
• Publication Number:
  US 20050113877A1
• Time in Patent Office: 1,532 Days
• Field of Search: 607 39- 41, 607/133, 607/138, 607/46
• US Class Current: 607/39
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0514 Electrodes for the urinary tract
• CPC Class Codes: A61N 1/0521 Genital electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• 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 the pudendal or other nerves, and optional means for delivering drugs in association therewith. A method of precisely positioning and implanting a medical electrical lead so as to provide optimal stimulation of the pudendal nerve or a portion thereof is also described. Placement of a stimulation lead next to or on the pudendal nerve may be performed using conventional prior art techniques through gross anatomical positioning, but usually does not result in truly optimal lead placement. One method of the present invention utilizes neurophysiological monitoring to assess the evoked responses of the pudendal nerve, and thereby provide a method for determining the optimal stimulation site. Additionally, one or more electrical stimulation signals are applied, and optionally one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient'"'"'s pelvic floor and pudendal nerve or portions thereof 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 for treating at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia in a patient, comprising:

implanting a distal end of a first implantable medical electrical lead in tissue of the patient adjacent, around or in one of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof, wherein the first lead comprises at least a first electrode;

operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead;

implanting the implantable pulse generator within the patient; and

delivering electrical stimulation pulses from the implantable pulse generator to one of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and delivered in a configuration effective to provide at least partial relief from at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

2. The method of claim 1, wherein the at least first lead comprises a beam steering lead comprising multiple electrodes.

3. The method of claim 1, wherein the at least first lead comprise an active fixation device or member disposed thereon, attached thereto or forming a portion thereof.

4. The method of claim 1, wherein the at least first lead includes a fixation device or member selected from the group consisting of a suture sleeve, a barb, a helical screw, a hook and a tissue in-growth mechanism.

5. The method of claim 1, further comprising providing, implanting, operably connecting and delivering electrical stimuli from a second implantable medical electrical lead, wherein the second lead comprises proximal and distal ends and at least one electrode.

6. The method of claim 5, further comprising delivering the electrical pulses through tissue disposed between the electrodes located on the first and second leads.

7. The method of claim 1, wherein the electrical stimulation pulses that are delivered to one of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof cause paresthesia, or the masking or blocking pain signals originating in or carried by a desired or target nerve or nerve portion located in the vicinity of the at least one electrode.

8. The method of claim 1, further comprising providing a lead extension, operably connecting same between the proximal end of the at least first lead and the implantable pulse generator, and delivering the electrical stimulation pulses through the lead extension.

9. The method of claim 1, wherein the first lead comprises at least one electrode selected from the group consisting of an electrode formed from a portion of wire, a barb or a hook, a spherically-shaped electrode, and a helically-shaped electrode.

10. The method of claim 1, wherein the distance between the proximal and distal ends of the at least first lead is selected from the 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.

11. The method of claim 1, wherein the implantable pulse generator and the at least first lead are capable of generating and delivering electrical pulses having frequencies ranging between about 50 Hz and about 100 Hz, between about 10 Hz and about 250 Hz, or between about 0.5 Hz and about 500 Hz.

12. The method of claim 1, wherein the implantable pulse generator and the at least first lead are capable of generating and delivering electrical pulses having amplitudes ranging between about 1 Volt and about 10 Volts, between about 0.5 Volts and about 20 Volts, or between about 0.1 Volts and about 50 Volts.

13. The method of claim 1, wherein the implantable pulse generator and the at least first lead are capable of generating and delivering electrical pulses having pulse widths ranging between about 180 microseconds and about 450 microseconds, between about 100 microseconds and about 1000 microseconds, or between about 10 microseconds and about 5000 microseconds.

14. The method of claim 1, wherein delivering first electrical stimulation pulses comprises:

generating a plurality of different electrical signals, electrical pulses of the electrical signals having respective spatial or temporal phases for respective delivery to the first lead and at least a second lead; and

delivering the pulses to one of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof.

15. The method of claim 1, wherein the electrical stimulation pulse regime provided to the patient is effective in providing at least one of urinary urgency relief or urinary frequency relief.

16. The method of claim 1, wherein the electrical stimulation pulse regime provided to the patient is effective in providing relief from sexual dysfunction.

17. The method of claim 1, further comprising concomitantly delivering a drug to the patient mid delivering the electrical stimulation regime.

18. The method of claim 17, further comprising providing, implanting and activating an implantable drug pump for providing the drug to the patient.

19. A method for treating urinary retention disorder in a patient comprising:

implanting a distal end of a first implantable medical electrical lead in tissue of the patient adjacent, around or in one of the pudendal nerve or branches or portions thereof, the prostatic plexus nerve or branches or portions thereof, the sacral splanchnic nerve or branches or portions thereof, the pelvic splanchnic nerve or branches or portions thereof, the prostate or branches or portions thereof, the pelvic floor, the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Carnal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foremen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof, wherein the first lead comprises at least a first electrode;

operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead;

implanting the implantable pulse generator within the patient; and

delivering electrical stimulation pulses from the implantable pulse generator to one of the pudendal nerve or branches or portions thereof, the prostatic plexus nerve or branches or portions thereof, the sacral splanchnic nerve or branches or portions thereof, the pelvic splanchnic nerve or branches or portions thereof, the prostate or branches or portions thereof, the pelvic floor, the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portion thereof, or lesser sciatic foramen or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and delivered in a configuration effective to provide at least partial relief from urinary retention disorder.

20. The method of claim 19,

wherein implanting the first lead comprises implanting the first lead in tissue of the patient adjacent, around or in one of the pudendal nerve or branches or portions thereof.

21. A method for treating at least one of prostatitis, prostatalgia or prostatodynia in a patient, comprising:

implanting a distal end of a first implantable medical electrical lead in tissue of the patient adjacent, around or in one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof, wherein the first lead comprises at least a first electrode;

operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead;

implanting the implantable pulse generator within the patient; and

delivering electrical stimulation pulses front the implantable pulse generator to one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and delivered in a configuration effective to provide at least partial relief from at least one of prostatitis, prostatalgia or prostatodynia,

wherein the electrical stimulation pulses that are delivered to one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof cause paresthesia, or the masking or blocking pain signals originating in or carried by a desired or target nerve or nerve portion located in the vicinity of the at least one electrode.

22. The method of claim 21, wherein implanting the first lead comprises:

delivering stimulation to a plurality of locations via a St. Mark'"'"'s electrode, the locations comprising cue or more of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foremen or branches or portions thereof, or lesser sciatic foremen or branches or portions thereof;

sensing an evoked response for each of the locations;

selecting one of the locations based on the evoked responses; and

implanting electrodes of the first lead adjacent, around, or in tissue at the selected location.

23. The method of claim 22, wherein sensing an evoked response comprises sensing an anal or vaginal electromyogram for each of the locations.

24. The method of claim 23, further comprising determining a latency of the electromyogram for each location, wherein selecting one of the locations comprises selecting the location based on the latency.

25. A method for treating at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia in a patient, comprising:

delivering stimulation to a plurality of locations via a St. Mark'"'"'s electrode, the locations comprising one or more of the sacral nerve or branches or portions thereof, the pudendal nerve or branches or portions thereof, the hypogastric nerve or branches or portions thereof, the prostatic plexus nerve or branches or portions thereof, the sacral splanchnic nerve or branches or portions thereof, the pelvic splanchnic nerve or branches or portions thereof, the prostate or branches or portions thereof, the pelvic floor, the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof;

sensing an evoked response for each of the locations;

selecting one of the locations based on the evoked responses;

implanting electrodes of the first implantable medical electrical lead in tissue of the patient adjacent, around or in the selected location; and

delivering electrical stimulation pulses from an implantable electrical pulse generator to at least a portion of the tissue of the patient through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and providing to the patient at least partial relief from at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

26. The method of claim 25, wherein sensing an evoked response comprises sensing an anal or vaginal electromyogram for each of the locations.

27. The method of claim 26, further comprising determining a latency of the electromyogram for each location, wherein selecting one of the locations comprises selecting the location based on the latency.

28. A method for treating pelvic pain comprising:

implanting a distal end of at least a first medical electrical lead in tissue of the patient adjacent, around or in at least one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, or the sacro-tuberous ligament or branches or portions thereof, wherein the first lead comprises at least a first electrode;

operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead;

implanting the implantable pulse generator within the patient; and

delivering electrical stimulation pulses from the implantable pulse generator to at least one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, or the sacro-tuberous ligament or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and in a configuration effective to provide the patient at least partial relief from pelvic pain,

wherein the electrical stimulation pulses that are delivered to the desired nerve target sites or portions cause paresthesia, or the masking or blocking pain signals originating in or carried by a desired or target nerve or nerve portion located in the vicinity of the at least one electrode.