Systems and methods for treating disorders by selectively activating and/or blocking muscles through intrafasicular stimulation of the pudendal nerve

• US 8,630,711 B1
• Filed: 10/02/2009
• Issued: 01/14/2014
• Est. Priority Date: 10/02/2008
• Status: Active Grant

• Current Assignee: University of Utah Research Foundation (State of Utah)
• Original Assignee: University of Utah Research Foundation (State of Utah)
• Inventors: Cartwright, Patrick C., Normann, Richard A., Wark, Heather A. C.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US12/572,866
• Time in Patent Office: 1,565 Days
• Field of Search: 607/39, 607/40, 607/41, 607/118, 607/138, 607/133, 607/143, 600 29- 30, 128/DIG.25
• US Class Current: 607/40
• 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 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36171 Frequency

Abstract

Methods and related systems for treating patients suffering from several disorders including bladder dysfunction, erectile dysfunction, and bowel elimination disorders are disclosed and described. The method can include identification of the disorder followed by the step of accessing a pudendal nerve of the patient. A microelectrode array having a plurality of electrodes thereon is inserted into the pudendal nerve of the patient. A controller is electronically associated with the microelectrode array which is programmed to provide selective activation and/or blocking of various muscles using the microelectrodes of the array. The selective stimulation can be tuned to selectively activate or block at least one muscle selected from the group consisting of the external urethral sphincter, the detrusor muscle, the anal sphincter, and the cavernous smooth musculature of the penis.

Claims

1. A method of treating a disorder comprising,

a. identifying a patient suffering from at least one disorder selected from the group consisting of bladder dysfunction, erectile dysfunction, and bowel elimination disorders;

b. accessing a first pudendal nerve of the patient;

c. providing a first microelectrode array having a plurality of microelectrodes that are electrically individually addressable, and the plurality of microelectrodes are mounted on a common planar substrate substantially perpendicular to one another;

d. inserting the first microelectrode array into the first pudendal nerve such that the plurality of microelectrodes penetrate intrafascicularly into the pudendal nerve;

e. electronically associating a controller with the first microelectrode array; and

f. programming the controller for selective stimulation by microelectrodes of the first micro electrode array, said selective stimulation being tuned for selective stimulation of at least one muscle selected from the group consisting of the external urethral sphincter, the detrusor muscle, the anal sphincter, and the cavernous smooth musculature of the penis.

2. The method of claim 1, wherein the controller is electronically associated with the microelectrode using a wireless signaling device.

3. The method of claim 1, further comprising a second microelectrode array implanted in the first pudendal nerve and electronically associated with the controller for unilateral stimulation.

4. The method of claim 1, further comprising a second microelectrode array implanted in a second pudendal nerve and electronically associated with the controller for bilateral stimulation.

5. The method of claim 1, wherein the selective stimulation is by high frequency alternating current.

6. The method of claim 5, wherein the high frequency current has a frequency of 0.5 kHz to about 20 kHz.

7. The method of claim 5, wherein the muscle is the external urethral sphincter and wherein the frequency is from about 1 kHz to about 3 kHz.

8. The method of claim 1, wherein the selective stimulation is by low frequency stimulation.

9. The method of claim 8, wherein the muscle is the detrusor muscle and the frequency is about 5 Hz to about 100 Hz.

10. The method of claim 8, wherein the low frequency stimulation is from about 10 Hz to about 50 Hz.

11. The method of claim 1, wherein the selective stimulation includes simultaneous low frequency stimulation by at least one microelectrode and high frequency stimulation by at least one other microelectrode of the first microelectrode array.

12. The method of claim 11, wherein the low frequency stimulation causes tonic activation of the detrusor muscle and wherein the high frequency stimulation stimulates and blocks efferent nerve fibers that innervate the external urethral sphincter causing the external urethral sphincter to relax.

13. The method of claim 1, wherein the microelectrode array is a Utah Slanted Electrode Array, a Flat Utah Electrode Array, a contoured Utah Electrode Array, or a planar array.

14. The method of claim 1, wherein the first microelectrode array is inserted such that each nerve fiber within the first pudendal nerve is within 200 microns of a microelectrode of the first microelectrode array.