Methods for selectively stimulating components in, on, or near the pudendal nerve or its branches to achieve selective physiologic responses

• US 7,623,925 B2
• Filed: 05/31/2005
• Issued: 11/24/2009
• Est. Priority Date: 03/30/2001
• Status: Expired due to Fees

• Current Assignee: Case Western Reserve University
• Original Assignee: Case Western Reserve University
• Inventors: Gustafson, Kenneth J, Creasey, Graham H, Grill, Warren M
• Primary Examiner(s): Schaetzle; Kennedy J
• Application Number:
  US11/141,457
• Publication Number:
  US 20050222636A1
• Time in Patent Office: 1,638 Days
• Field of Search: 607 39- 41, 607/2, 607/62, 607/118, 607/138
• US Class Current: 607/41
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Systems and methods selectively stimulate components of the pudendal nerve away from the sacral root to evoke desired physiologic responses in persons who lack the ability to otherwise produce these responses—e.g., maintain continence and/or produce micturition, and/or provide male/female sexuality responses, and/or provide bowel responses. The systems and methods use a multiple electrode array, or individual electrodes, placed on, in, or near the pudendal nerve. The electrode array, or individual electrodes, in association with a pulse generator, provide selective stimulation of individual fascicles within the pudendal nerve, to achieve different physiologic responses.

Claims

1. A method comprising

identifying at least one desired physiologic function selected from the group consisting essentially of controlling a urinary tract function, controlling a bowel function, and controlling a sexual function,

identifying at least two targeted afferent and/or efferent pudendal nerve components that, when selectively stimulated in combination, affect the desired physiologic function,

placing an electrode configuration in a region of tissue away from a sacral root that includes the targeted afferent and/or efferent pudendal nerve components, and

tuning the electrode configuration to achieve a combined selective electrical stimulation of the targeted afferent and/or efferent pudendal nerve components in the region to achieve the desired physiologic function.

2. A method according to claim 1

wherein the targeted efferent pudendal nerve component comprises an efferent urethral nerve component.

3. A method according to claim 1

wherein the targeted afferent pudendal nerve component comprises an afferent urethral nerve component.

4. A method according to claim 1

wherein the targeted afferent pudendal nerve component comprises an afferent genital nerve component.

5. A method according to claim 1

wherein the desired physiologic function comprises controlling urinary incontinence.

6. A method according to claim 1

wherein the desired physiologic function comprises controlling micturition.

7. A method according to claim 1

wherein the desired physiologic function comprises controlling ejaculation.

8. A method according to claim 1

wherein the targeted afferent and/or efferent pudendal nerve components comprise at least one afferent pudendal nerve component and at least one efferent pudendal nerve component, and wherein the tuning achieves a combined electrical stimulation of the targeted afferent pudendal nerve component in the region in tandem with the targeted efferent pudendal nerve component in the region to achieve the desired physiologic function.

9. A method according to claim 8

wherein the targeted afferent and/or efferent pudendal nerve components comprise a urethral afferent nerve component and a urethral efferent nerve component,

wherein the selective electrical stimulation of the targeted urethral efferent nerve component affects nerve inactivation and relaxation of a urinary sphincter,

wherein the selective electrical stimulation of the targeted urethral afferent nerve component affects nerve activation and contraction of a bladder, and

wherein the combined selective electrical stimulation achieves micturition.

10. A method according to claim 8

wherein the targeted afferent and/or efferent pudendal nerve components comprise a genital afferent nerve component and a urethral efferent nerve component,

wherein the selective electrical stimulation of the targeted urethral efferent nerve component affects nerve activation and tightening of a urinary sphincter,

wherein the selective electrical stimulation of the targeted genital afferent nerve component affects nerve activation and inhibition of bladder contractions, and

wherein the combined selective electrical stimulation achieves urinary continence.

11. A method according to claim 1

wherein the tuning includes defining operating parameters for the electrode configuration.

12. A method according to claim 11

wherein the electrode configuration includes a single electrode.

13. A method according to claim 11

wherein the electrode configuration includes a multiple electrode array.

14. A method according to claim 1

wherein the region of tissue includes a pudendal nerve trunk.