Implantable neuromodulation system and method

• US 7,729,772 B2
• Filed: 01/07/2005
• Issued: 06/01/2010
• Est. Priority Date: 01/07/2005
• Status: Active Grant

• Current Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Original Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Inventors: Williams, Jeffrey M., van den Biggelaar, Hans
• Primary Examiner(s): Evanisko; George R
• Application Number:
  US10/905,501
• Publication Number:
  US 20060155345A1
• Time in Patent Office: 1,971 Days
• Field of Search: 607/40, 607/46, 607 59- 61, 607/41
• US Class Current: 607/41
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An implantable neuromodulation system and method of treating a patient through neuromodulation of a patient'"'"'s body tissue. The neuromodulation system includes a portable transmitter and an implantable receiver. The implantable receiver includes one or more electrodes disposed on the distal end of one or more elongated, flexible insulated leads. The transmitter is programmable with a treatment protocol to cause the transmitter to generate a pulsed, alternating magnetic field in accordance with the treatment protocol. When the transmitter is placed in close proximity to the receiver, the alternating magnetic field pulses generated by the transmitter cause the receiver to operably generate stimulating pulses delivered via the electrode(s) to the targeted tissue of the patient.

Claims

1. A method of treating urinary incontinence in a patient through neuromodulation of body tissue of the patient at a desired internal stimulation site, comprising:

implanting a receiver subcutaneously in the patient, the receiver comprising passive receiver circuitry, a dielectric, bio-compatible shell encapsulating the receiver circuit, a first elongated resiliently-insulated flexible helical electrically conductive wire lead extending from the shell, a first electrode disposed at a distal end of the first lead and electrically connected to the receiver circuitry through the first lead to function as an anode, a second elongated resiliently-insulated flexible helical electrically conductive wire lead extending from the shell, and a second electrode disposed at a distal end of the second lead and electrically connected to the receiver circuitry through the second lead to function as a cathode;

during the implanting step, positioning the first and second electrodes in proximity to a tibial nerve of the patient, approximately five centimeters cephalic to the medial tibial malleolus, by elongation of at least one of the first and second leads, and supplying a first pulsed alternating magnetic field to the receiver from a portable transmitter outside of the patient to test for accurate positioning of the first and second electrodes as indicated by a curl or curve of a foot of the patient; and

supplying a second pulsed alternating magnetic field to the receiver from the portable transmitter outside of the patient,

wherein the second pulsed alternating magnetic field comprises alternating magnetic field pulses have pulse frequency, pulse amplitude and pulse width characteristics corresponding to a predetermined treatment protocol for urinary incontinence; and

wherein the first and second alternating magnetic field pulses inductively couple to the passive receiver circuitry to generate treatment current pulses therein in accordance with the treatment protocol, the treatment current pulses being supplied to the electrode through the lead for stimulating the tibial nerve.

2. The method of claim 1 further comprising:

adjusting the pulse frequency to a value between approximately four Hz and approximately forty Hz;

adjusting the pulse amplitude to a value between approximately 0.1 mA and approximately 20 mA; and

adjusting the pulse width in predefined increments.

3. A method of treating a patient for urinary incontinence by neuromodulation of a tibial nerve of the patient, said method comprising the steps of:

providing a portable transmitter, said transmitter being programmed with a treatment protocol for urinary incontinence and including circuitry to generate a pulsed alternating magnetic field in accordance with said treatment protocol;

implanting a receiver subcutaneously in said patient in relative proximity to said tibial nerve, said receiver having receiver circuitry that, when exposed to said pulsed alternating magnetic field, generates current pulses, said receiver circuitry being encapsulated in a dielectric, bio-compatible shell, and further wherein said receiver includes a first electrode disposed at a distal end of a first elongated, flexible lead and electrically connected to said receiver circuitry by the first lead to function as an anode, and a second electrode disposed at a distal end of a second elongated, flexible lead and electrically connected to said receiver circuitry by the second lead to function as a cathode, the first lead comprising a flexible, helical electrically conductive wire encapsulated within a dielectric, bio-compatible resilient casing, and the second lead comprising a flexible, helical electrically conductive wire encapsulated within a dielectric, bio-compatible resilient casing;

during the implanting step, positioning said first electrode and said second electrode in proximity to said tibial nerve by elongation of at least one of the first and second leads, and activating said transmitter to generate said pulsed alternating magnetic field to thereby cause said receiver to produce said current pulses for stimulating said tibial nerve, wherein accurate placement of the first and second electrodes is indicated by a curl or curve of a foot of the patient; and

activating said transmitter to generate said pulsed alternating magnetic field pursuant to said predetermined treatment protocol to thereby cause said receiver to produce said current pulses for stimulating said tibial nerve in proximity to said first and second electrodes.

4. The method of claim 3 wherein said treatment protocol includes a duration, further comprising selectively adjusting the duration of said treatment protocol at predetermined increments.

5. The method of claim 4 wherein said treatment protocol includes a pulse frequency, further comprising selectively adjusting the pulse frequency of said treatment protocol at predetermined increments.

6. The method of claim 5 wherein said treatment protocol includes a pulse amplitude, further comprising selectively adjusting the pulse amplitude of said treatment protocol in predetermined increments.

7. The method of claim 3 wherein said first electrode comprises two spaced, electrically independent buttons that function as anodes during said activating step, and wherein said second electrode comprises at least two spaced, electrically independent buttons that function as cathodes during said activating step.

8. The method of claim 7 wherein said first and second leads each includes at least two flexible, helical, electrically conductive wires encapsulated within said dielectric, biocompatible casing with a distal end of each flexible, helical, electrically conductive wire of said first lead electrically connecting said receiver circuitry to each of said spaced, electrically independent buttons of the first electrode, and a distal end of each flexible, helical, electrically conductive wire of said second lead electrically connecting said receiver circuitry to each of said spaced, electrically independent buttons of the second electrode.

9. The method of claim 3 wherein said positioning step comprises positioning said first electrode and said second electrode in proximity to said patient'"'"'s tibial nerve, approximately five centimeters cephalic to the medial tibial malleolus.

10. The method of claim 9 wherein said treatment protocol defines a treatment duration having a duration range of between approximately fifteen minutes and approximately 90 minutes, further comprising selectively adjusting the treatment duration to a value within the duration range.

11. The method of claim 10 wherein said treatment protocol defines a pulse frequency having a frequency range of between approximately four Hz and approximately forty Hz, further comprising selectively adjusting the pulse frequency to a value within the frequency range.

12. The method of claim 9 wherein said treatment protocol defines a pulse amplitude having an amplitude range of between approximately 0.1 mA and approximately 20 mA, further comprising selectively adjusting the pulse amplitude to a value within the amplitude range.

13. The method of claim 12 wherein said treatment protocol defines a pulse width that varies in predefined increments, further comprising selectively adjusting the pulse width to a value in accordance with the predefined increments.