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

• US 8,396,555 B2
• Filed: 06/24/2009
• Issued: 03/12/2013
• Est. Priority Date: 09/12/2003
• Status: Expired due to Fees

• Current Assignee: Case Western Reserve University
• Original Assignee: Case Western Reserve University
• Inventors: Boggs, Joseph W. II, Wenzel, Brian J., Gustafson, Kenneth J., Grill, Warren M.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US12/490,611
• Publication Number:
  US 20090326603A1
• Time in Patent Office: 1,357 Days
• Field of Search: 607/41
• US Class Current: 607/41
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36196 Frequency modulation
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

Apparatus to control physiological functions, including urinary track physiological functions are described. The apparatus includes an electrode(s) configured to be placed on or in a targeted component of a pudendal nerve and to stimulate the targeted pudendal nerve pudendal. The targeted component of the pudendal nerve includes a pudendal nerve urethral afferent, and afferent nerve fibers in the deep perineal nerve. The apparatus includes a controller coupled to the electrode to apply an electrical signal having an amplitude and a selected frequency chosen to stimulate the targeted component. The controller operates in a first mode to apply a first frequency without substantially changing the amplitude for achieving a first physiologic response and the controller operates in a second mode to apply a second frequency, different than the first frequency, for achieving a second physiologic response different than the first physiologic response.

Claims

1. An apparatus comprising:

one or more electrodes configured to be placed on or in a targeted component of a pudendal nerve and to stimulate the targeted component of the pudendal nerve, where the targeted component of the pudendal nerve includes one or more of, a urethral afferent of the pudendal nerve, and afferent nerve fibers in the deep perineal nerve;

a programmable controller coupled to the one or more electrodes, the programmable controller being programmable to selectively apply a member of a set of electrical signals to the one or more electrodes to stimulate the targeted component of the pudendal nerve,

where the programmable controller applies a first member of the set of electrical signals to the one or more electrodes to produce a first physiologic response, the first member of the set of electrical signals being generated according to a first set of predefined attributes, and

where the programmable controller applies a second member of the set of electrical signals to the one or more electrodes to produce a second physiologic response, the second member of the set electrical signals being generated according to a second set of predefined attributes,

where the first physiologic response is controlling urinary incontinence and the second physiologic response is controlling micturition,

where the first set of predefined attributes and the second set of predefined attributes control the programmable controller to generate electrical signals having a set of attributes including a waveform, an amplitude, and a frequency, the amplitude being in the range of 1 mA to 50 mA, the frequency being in the range of 1 Hertz to 50 Hertz, the amplitude being the same for both the first set of predefined attributes and the second set of predefined attributes, and

where controlling urinary incontinence is stimulated by applying an electrical signal with a frequency in the range of 1 Hz to 5 Hz and controlling micturition is stimulated by applying an electrical signal with a frequency in the range of 15 Hz to 25 Hz.

2. The apparatus of claim 1, where the first set of predefined attributes and the second set of predefined attributes control the programmable controller to generate electrical signals where the waveform is one of, a square waveform, and a ramped shaped waveform.

3. The apparatus of claim 1, comprising:

a remote controller to communicate with the programmable controller, where the remote controller provides a selected mode of operation to the programmable controller, and

where the programmable controller generates an electrical signal with predefined attributes based, at least in part, on the selected mode of operation.

4. The apparatus of claim 3, where the selected mode of operation is one of, a low power state, a medium power state, and a high power state.

5. The apparatus of claim 4, where the lower power state includes controlling the programmable controller to generate electrical signals with an amplitude in the range of 1 mA to 10 mA;

where the medium power state includes controlling the programmable controller to generate electrical signals with an amplitude in the range of 10 mA to 20 mA; and

where the high power state includes controlling the programmable controller to generate electrical signals with an amplitude in the range of 20 Ma to 50 Ma.

6. The apparatus of claim 4, where the lower power state includes controlling the programmable controller to generate electrical signals with a frequency in the range of 1 Hz to 5 Hz;

where the medium power state includes controlling the programmable controller to generate electrical signals with a frequency in the range of 5 Hz to 25 Hz; and

where the high power state includes controlling the programmable controller to generate electrical signals with an amplitude in the range of 25 Hz to 50 Hz.

7. An apparatus, comprising:

an electrode configured to stimulate one or more of, a urethral afferent of the pudendal nerve and afferent nerve fibers in the deep perineal nerve to produce a first physiologic response and a second physiologic response; and

a programmable controller coupled to the electrode, where the programmable controller functions to selectively apply a first electrical signal to the electrode, based, at least in part, on a first predefined set of attributes describing a first current to produce the first physiologic response, the controller applying a second electrical signal to the electrode, based, at least in part, on a second predefined set of attributes describing a second current different from the first current to produce the second physiologic response, where the electrical signal stimulates one or more of, the urethral afferent of the pudendal nerve and afferent nerve fibers in the deep perineal nerve.

8. The apparatus of claim 7, the first physiologic response being continence, the second physiologic response being micturition.

9. The apparatus of claim 8, where the first predefined set of attributes and the second predefined set of attributes describe a waveform, the waveform being one of, a square waveform, and a ramped shaped waveform.

10. The apparatus of claim 8, where first predefined set of attributes and the second predefined set of attributes describe a frequency.

11. The apparatus of claim 10, the frequency being in the range of 1 Hz to 50 Hz.

12. The apparatus of claim 8, where the first predefined set of attributes and the second predefined set of attributes describe a waveform, a frequency, and the respective first and second currents, the waveform being one of, a square waveform, and a ramped shaped waveform, the frequency being in the range of 1 Hz to 50 Hz, and each of the first current and the second current being in the range of 1 mA to 50 mA.

13. The apparatus of claim 8, where the programmable controller is configured to identify a waveform, a frequency, and the first current associated with producing the first physiologic response and to store the first set of attributes associated with producing the first physiologic response.

14. The apparatus of claim 13, where the programmable controller is configured to identify a waveform, a frequency, and the second current associated with producing the second physiologic response and to store the second set of attributes associated with producing the second physiologic response.

15. The apparatus of claim 14, where the programmable controller is configured to select one of, the first set of attributes associated with producing the first physiologic response, and the second set of attributes associated with producing the second physiologic response as a function of a user input.

16. The apparatus of claim 15, the first physiologic response being continence, the second physiologic response being micturition.

17. The apparatus of claim 7, each of the first current and the second current being in the range of 1 mA to 50 mA.

18. The apparatus of claim 7, wherein the first electrical signal has a first frequency and an amplitude, the second electrical signal having a second frequency different from the first frequency and the amplitude.

19. The apparatus of claim 7, wherein the controller provides for a plurality of different electrical signals, each having a different set of attributes, for producing different levels of effectiveness for the first physiologic response.

20. An apparatus comprising:

an electrode configured to stimulate one or more of a urethral afferent of the pudendal nerve and afferent nerve fibers in the deep perineal nerve to produce a first physiologic response and a second physiologic response; and

a programmable controller coupled to the electrode to selectively apply a first electrical signal to the electrode having an amplitude and a first frequency to produce a first physiologic response, the controller applying a second electrical signal to the electrode having the amplitude and a second frequency different from the first frequency to produce a second physiologic response different from the first physiologic response.