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

• US 9,446,245 B2
• Filed: 08/29/2014
• Issued: 09/20/2016
• Est. Priority Date: 03/30/2001
• Status: Expired due to Term

• 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:
  US14/473,059
• Publication Number:
  US 20140371803A1
• Time in Patent Office: 753 Days
• Field of Search: None
• US Class Current: 1/1
• 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 system, comprising:

a pulse generator configured to generate a stimulation waveform based on an input related to a desired physiological function; and

a plurality of electrodes coupled to the pulse generator to selectively stimulate a component of the pudendal nerve,

wherein the pulse generator is configured to select one of the plurality of electrodes to receive the stimulation waveform based on the desired physiological function and a stored tuning record of the plurality of electrodes.

2. The system of claim 1, further comprising a control signal source configured to generate the input associated with the desired physiological function.

3. The system of claim 1, wherein the component of the pudendal nerve comprises at least one of an afferent fascicle and an efferent fascicle.

4. The system of claim 1, wherein the pulse generator is configured to deliver the stimulation waveform to one of the plurality of electrodes based on the input.

5. The system of claim 1, wherein the stimulation waveform comprises a pre-programmed pattern of electrical signals.

6. The system of claim 1, wherein the desired physiologic response comprises at least one of a lower urinary tract function, a lower bowel function, and a sexual function.

7. The system of claim 1, wherein the plurality of electrodes is arranged in an array located in proximity to the pudendal nerve.

8. The system of claim 1, further comprising a recording electrode configured to detect a physiological parameter and send a signal related to the detected physiological parameter to the pulse generator as the input related to a desired physiological function.

9. The system of claim 1, wherein the pulse generator comprises a memory that stores the tuning record a plurality of stimulation parameters and a processor configured to generate the stimulation waveform based on a portion of the tuning record.

10. A system, comprising:

a first electrode configured to be located in proximity to a first component of a nerve;

a second electrode configured to be located in proximity to a second component of the nerve;

a pulse generator coupled to the first electrode and the second electrode and configured to generate a stimulation waveform based on an input related to a desired physiological function and select at least one of the first electrode and the second electrode to receive the stimulation waveform based on a stored tuning record of the first electrode and the second electrode.

11. The system of claim 10, wherein at least one of the first component of the nerve and the second component of the nerve comprises at least one of an afferent fascicle and an efferent fascicle.

12. The system of claim 10, further comprising a recording electrode configured to detect a physiological parameter and send a signal related to the detected physiological parameter to the pulse generator as the input related to a desired physiological function.

13. The system of claim 10, further comprising a control signal source configured to receive a volitional input from a patient related to the desired physiological function and generate the input associated with the desired physiological function.

14. The system of claim 10, wherein the stimulation waveform comprises a pre-programmed pattern of electrical signals based on the desired physiological function.

15. The system of claim 10, further comprising a multi-electrode cuff comprising the first electrode and the second electrode.

16. A method, comprising:

receiving, at a pulse generator comprising a processor, a signal related to a desired physiological function;

generating, by the pulse generator, a stimulation waveform based on the desired physiological function; and

selecting, by the pulse generator, an electrode of a plurality of electrodes to receive the stimulation waveform based on the desired physiological function and a stored tuning record of the plurality of electrodes.

17. The method of claim 16, wherein the desired physiological function is at least one of a urinary tract function, a bowel function, and a sexual function.

18. The method of claim 16, wherein the signal related to a desired physiological function is at least one of a volitional signal from the patient and a signal from a recording electrode related to a physiological signal.

19. The method of claim 16, wherein the tuning record is based on a tuning process of the plurality of electrodes.

20. The method of claim 19, wherein the tuning process comprises defining operating parameters for the plurality of electrodes.