Method and apparatus for fitting a patient with a body cavity electrode

• US 4,909,263 A
• Filed: 10/28/1988
• Issued: 03/20/1990
• Est. Priority Date: 10/28/1988
• Status: Expired due to Fees

• Current Assignee: EMPI Incorporated (Enovis Corp.)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Norris, Steven A.
• Primary Examiner(s): Hindenburg, Max
• Application Number:
  US07/264,019
• Time in Patent Office: 508 Days
• Field of Search: 128/303.13-303.17, 128/341-343, 128/738, 128/778, 128/784, 128/788, 604/117
• US Class Current: 607/39
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0524 Vaginal electrodes

Abstract

An elongate relatively rigid and electrically insulated vehicle is disclosed for use in fitting a vaginal or anal electrical stimulator used in treatment of urinary incontinence or sexual disfunction. The vehicle has spaced electrodes along its length which may be selectively actuated by a control unit to apply a pulsing voltage to the pelvic floor muscles. Pressure transducers located adjacent the electrodes measure the pressure applied by the muscles on the canal wall and a scale on the proximal end of the vehicle is used to determine the proper positioning of the electrodes and length of the vehicle for use in fashioning and fitting the patient with a proper electrical stimulator. A method for fitting the patient with such a stimulator using the vehicle is also disclosed.

Claims

1. Apparatus for electrically stimulating the muscles surrounding a body cavity and for measuring body cavity pressure during such stimulation for properly fitting a patient with an electrical stimulator treatment device, comprising an elongated cylindrical vehicle, said vehicle being substantially rigid and adapted to fit within the body cavity, a plurality of circumferential electrodes spaced along the vehicle and adapted to contact the body cavity wall, means for selectively providing an electrical voltage to selected ones of said electrodes to stimulate the muscles adjacent the body cavity, pressure transducer means mounted on said vehicle adjacent said electrodes for sensing cavity wall pressure wherein the optimum position of said vehicle in said cavity is determined by sensing the response to stimulation, and means for reading said pressure.

2. An apparatus as defined in claim 1, wherein the electrical voltage provided is in the form of a plurality of pulses of relatively short duration, and further including means to adjust the amplitude and the frequency of said pulses.

3. An apparatus as defined in claim 1, and further including scale markings on the vehicle adjacent the proximal end to measure vehicle insertion depth within the body cavity at the point of optimum positioning of said vehicle through said pressure reading.

4. Apparatus for use in fitting a patient with an electrical body cavity stimulator comprising, an elongated cylindrical vehicle adapted for insertion in a body cavity, said vehicle being substantially rigid and carrying a plurality of axially spaced circumferential electrodes along a portion of its length, said electrodes adapted to contact the wall of the patient'"'"'s body cavity, pressure transducer mounted on said vehicle adjacent said electrodes for sensing cavity wall pressure wherein the optimum position of said vehicle in said cavity is determined by sensing the response to stimulation, a control unit external of said vehicle, said control unit including means for selectively providing an electrical voltage to selected ones of said electrodes, conductor means for connecting said electrodes to means for providing electrical voltage, and gauge means on said control unit to provide a reading of pressure from a selected transducer.

5. Apparatus as defined in claim 4, wherein the means for providing an electrical voltage, supplies said voltage in the form of a plurality of pulses of relatively short duration, and means are further provided in the control unit to selectively adjust the amplitude and the frequency of said pulses.

6. Apparatus as defined in claim 4, and further including scale markings on the vehicle adjacent the proximal end to measure vehicle insertion depth within the body cavity at the point of optimum positioning of said vehicle through said pressure reading.

7. A method for fitting a patient with a body cavity electrical stimulator, comprising the steps of, inserting an elongate vehicle within the cavity to a selected depth, said vehicle provided with spaced means along its length for providing a pulsing electrical stimulation to the adjacent body cavity wall and with spaced pressure measuring means also along its length, applying electrical stimulation to the patient through a selected pair of said spaced means, measuring the pressure generated by a selected pair of pressure measuring means, changing the depth of vehicle insertion until the measured pressures are substantially equal, and measuring the depth of vehicle insertion that provided the equal pressures.

8. A method as defined in claim 7, and further including the step of measuring the electromyography (EMG) during the period of electrical stimulation.

9. A method as defined in claim 7, wherein the elongate vehicle is inserted in the vagina.

10. A method as defined in claim 7, wherein the elongate vehicle is inserted in the anus.

11. Apparatus for electrically stimulating the muscles surrounding a body cavity and for measuring body cavity pressure during such stimulation for properly fitting a patient with an electrical stimulator treatment device, comprising an elongated cylindrical vehicle, said vehicle being substantially rigid and adapted to fit within the body cavity, a plurality of circumferential electrodes spaced along the vehicle and adapted to contact the body cavity wall, means for selectively providing an electrical voltage to selected ones of said electrodes to stimulate the muscles adjacent the body cavity, pressure transducer means mounted on said vehicle adjacent said electrodes for sensing cavity wall pressure, means for reading said pressure, said means for providing an electrical voltage being external to said vehicle and further including an axial passageway extending longitudinally within the vehicle, electrical conductor means connected to each electrode, said conductor means passing through said passageway and extending out of said vehicle and being connected to said means for providing an electrical voltage, said pressure transducer means comprising a plurality of substantially annular hollow rings of expandable material, said rings each filled with a fluid, and conduit means connecting said rings to said means for reading pressure.

12. Apparatus for use in fitting a patient with an electrical body cavity stimulator comprising, an elongated cylindrical vehicle adapted for insertion in a body cavity, said vehicle being substantially rigid and carrying a plurality of axially spaced circumferential electrodes along a portion of its length, said electrodes adapted to contact the wall of the patient'"'"'s body cavity, pressure transducer mounted in said vehicle adjacent said electrodes for sensing cavity wall pressure and a control unit external of said vehicle, said control unit including means for selectively providing an electrical voltage to selected ones of said electrodes, conductor means for connecting said electrodes to means for providing electrical voltage, and gauge means on said control unit to provide a reading of pressure from a selected transducer, said vehicle further including an axial passageway extending longitudinally within said vehicle, said conductor means passing through said passageway, and conduit means extending through said passageway for connecting said pressure transducers to said gauge means.

13. Apparatus for use in fitting a patient with an electrical body cavity stimulator comprising, an elongated cylindrical vehicle adapted for insertion in a body cavity, said vehicle being substantially rigid and carrying a plurality of axially spaced circumferential electrodes along a portion of its length, said electrodes adapted to contact the wall of the patient'"'"'s body cavity, pressure transducer mounted in said vehicle adjacent said electrodes for sensing cavity wall pressure and a control unit external of said vehicle, said control unit including means for selectively providing an electrical voltage to selected ones of said electrodes, conductor means for connecting said electrodes to means for providing electrical voltage, gauge means on said control unit to provide a reading of pressure from a selected transducer, and said vehicle body being formed with a plurality of circumferential channels, said electrodes and said pressure transducer means each fitting within separate channels.

14. Apparatus for use in fitting a patient with an electrical body cavity stimulator comprising, an elongated cylindrical vehicle adapted for insertion in a body cavity, said vehicle being substantially rigid and carrying a plurality of axially spaced circumferential electrodes along a portion of its length, said electrodes adapted to contact the wall of the patient'"'"'s body cavity, pressure transducer means mounted on said vehicle adjacent said electrodes for sensing cavity wall pressure, a control unit external of said vehicle, said control unit including means for selectively providing an electrical voltage to selected ones of said electrodes, conductor means for connecting said electrodes to means for providing electrical voltage, gauge means on said control unit to provide a reading of pressure from a selected transducer, said vehicle further including an axial passageway extending longitudinally within the vehicle, said conductor means passing through said passageway, conduit means extending through said passageway for connecting said pressure transducers to said gauge means, and said pressure transducer means comprising a plurality of substantially annular hollow rings of expandable material, said rings each filled with a fluid.

15. Apparatus for use in fitting a patient with an electrical body cavity stimulator comprising, an elongated cylindrical vehicle adapted for insertion in a body cavity, said vehicle being substantially rigid and carrying a plurality of axially spaced circumferential electrodes along a portion of its length, said electrodes adapted to contact the wall of the patient'"'"'s body cavity, pressure transducer mounted in said vehicle adjacent said electrodes for sensing cavity wall pressure, a control unit external of said vehicle, said control unit including means for selectively providing an electrical voltage to selected ones of said electrodes, conductor means for connecting said electrodes to means for providing electrical voltage, gauge means on said control unit to provide a reading of pressure from a selected transducer, said vehicle further including an axial passageway extending longitudinally within the vehicle, said conductor means passing through said passageway, conduit means extending through said passageway for connecting said pressure transducers to said gauge means, said pressure transducer means comprising a plurality of substantially annular hollow rings of expandable material, said rings each filled with a fluid, and further including means on said control unit for providing a reading of electromography (EMG).