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

• US 8,825,163 B2
• Filed: 10/15/2009
• Issued: 09/02/2014
• Est. Priority Date: 03/30/2001
• Status: Active Grant

• Current Assignee: Case Western Reserve University
• Original Assignee: Case Western Reserve University
• Inventors: Grill, Warren M., Gustafson, Kenneth J., Creasey, Graham H.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US12/579,581
• Publication Number:
  US 20100094372A1
• Time in Patent Office: 1,783 Days
• Field of Search: None
• 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 two targeted afferent and/or efferent pudendal nerve components that, when selectively stimulated affect the desired physiologic function; and

tuning an electrode configuration to achieve a selective electrical stimulation of the targeted afferent and/or efferent pudendal nerve components to achieve a desired physiologic function, the electrode configuration being positioned in a region of tissue away from a sacral root that includes the targeted afferent and/or efferent pudendal nerve components.

2. The method of claim 1:

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

3. The method of claim 1

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

4. The method of claim 1

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

5. The method of claim 1

where the desired physiologic function comprises controlling urinary incontinence.

6. The method of claim 1

where the desired physiologic function comprises controlling micturition.

7. The method of claim 1

where the desired physiologic function comprises controlling ejaculation.

8. The method of claim 1

where 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 where the tuning achieves 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. The method of claim 8

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

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

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

where the selective electrical stimulation achieves micturition.

10. The method of claim 8

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

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

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

where the selective electrical stimulation achieves urinary continence.

11. The method of claim 1

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

12. The method of claim 11

where the electrode configuration includes a single electrode.

13. The method of claim 11

where the electrode configuration includes a multiple electrode array configured to stimulate selectively the targeted afferent and/or efferent pudendal nerve components.

14. The method of claim 1

where the region of tissue includes a pudendal nerve trunk.

15. The method of claim 1, wherein the multiple electrode 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.

16. A method comprising:

identifying at least two targeted afferent and/or efferent pudendal nerve components;

implanting a multiple electrode array on a pudendal nerve trunk, the multiple electrode array being configured to stimulate selectively the targeted afferent and/or efferent pudendal nerve components; and

tuning the multiple electrode array to achieve a selective electrical stimulation of the targeted afferent and/or efferent pudendal nerve components to achieve a desired physiologic function, the multiple electrode array being positioned in a region of tissue away from a sacral root that includes the targeted afferent and/or efferent pudendal nerve components;

wherein said tuning comprises (i) mapping relative positions 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.

17. The method of claim 16, wherein the implantation step further comprises the steps of:

implanting an electrical pulse generator that includes a programmable microprocessor carrying embedded code;

coupling a lead to connect the multiple electrode array to the electrical pulse generator at a location remote from the multiple electrode array; and

after tuning the multiple electrode array, electrically stimulating the pudendal nerve trunk, the 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 selective stimulation to affect the desired physiologic function.