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

• US 6,907,293 B2
• Filed: 03/29/2002
• Issued: 06/14/2005
• Est. Priority Date: 03/30/2001
• Status: Active Grant

• Current Assignee: Case Western Reserve University
• Original Assignee: Case Western Reserve University
• Inventors: Creasey, Graham H., Grill, Warren M., Gustafson, Kenneth J.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US10/113,828
• Publication Number:
  US 20030004553A1
• Time in Patent Office: 1,173 Days
• Field of Search: 607/2, 607/39, 607/40, 607/41, 607/62, 607/118, 607/138
• US Class Current: 607/39
• 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 urinary incontinence, controlling micturition, controlling fecal incontinence, controlling defecation, controlling peristalsis, controlling erection, controlling vaginal lubrication, controlling ejaculation, and controlling orgasm,

providing an array of spaced apart electrodes,

providing an electrical pulse generator that includes a programmable microprocessor carrying embedded code,

placing the array on, in, or near a pudendal nerve trunk away from a sacral root, the pudendal nerve trunk comprising afferent and efferent nerve components,

coupling a lead to connect the array to the electrical pulse generator at a location remote from the array,

tuning the array by programming the embedded code in the microprocessor, said tuning comprising (i) mapping relative portion of targeted electrode or electrodes in the array with respect to the afferent and/or efferent components of the pudendal nerve trunk that, when selectively stimulated, affect the desired physiologic function and (ii) defining operating parameters for the targeted electrode or electrodes to achieve the selective stimulation, and

after tuning the array, electrically stimulating the pudendal nerve trunk, said stimulation comprising enabling operation of the electrical pulse generator to transmit to the targeted electrode or electrodes electrical stimulation waveforms having the defined operating parameters to achieve the selectively stimulation to affect the desired physiologic function.

2. A method according to claim 1

wherein at least two desired physiologic functions are identified, and

wherein the array is tuned to affect all identified physiologic functions on a selective basis.

3. A method according to claim 1

wherein the desired physiologic function selected comprises controlling urinary incontinence, and

wherein the array is tuned to stimulate an afferent genital component, or an efferent urethral component, or both.

4. A method according to claim 1

wherein the desired physiologic function selected comprises controlling micturition, and

wherein the array is tuned to stimulate an afferent urethral component, or an efferent urethral component, or both.

5. A method according to claim 1

wherein the desired physiologic functions selected comprises controlling urinary incontinence and controlling micturition, and

wherein the array is tuned to operate in a first mode to stimulate an afferent genital component, or an efferent urethral component, or both to affect control of urinary incontinence and to operate in a second mode to stimulate an afferent urethral component, or an efferent urethral component, or both to affect control of micturition.

6. A method according to claim 1

wherein the electrical pulse generator is enabled in response to a volitional act of an individual.

7. A method according to claim 1

further including placing at least one recoding electrode on, in, or near a nerve to sense electrical events, and

wherein the electrical pulse generator is enabled in response to the sensed electrical events.

8. A method according to claim 1

wherein the array, electrical pulse generator, and the lead are implanted.