Electrical stimulation for treatment of incontinence and other neuromuscular disorders

• US 5,562,717 A
• Filed: 11/08/1994
• Issued: 10/08/1996
• Est. Priority Date: 05/23/1992
• Status: Expired due to Term

• Current Assignee: Axelgaard Manufacturing Co. Ltd.
• Original Assignee: Axelgaard Manufacturing Co. Ltd.
• Inventors: Tippey, Keith E., Axelgaard, Jens
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Jastrzab, Jeffrey R.
• Application Number:
  US08/335,750
• Time in Patent Office: 700 Days
• Field of Search: 607/39-41, 607/115, 607/138, 607/148, 607/152, 607/72-74, 607/143
• US Class Current: 607/41
• CPC Class Codes: A61B 5/227 of constricting muscles, i.e. sphincters
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0524 Vaginal electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control

Abstract

Electrical stimulation for the treatment of neuro-muscular disorders, in particular incontinence. A portable electrical stimulation apparatus for treatment of incontinence, comprising one or more electrodes (302) for applying one or more electrical stimulation signals to a patient'"'"'s body, a signal generator for generating the electrical stimulation signal(s), one or more conductive leads for connecting the signal generator to the electrode(s), to deliver the electrical stimulation signal to the electrode(s); and a power supply, characterized in that the apparatus includes an instruction storage or a programming device for imparting a set of instructions to the signal generator, the signal generator being responsive to the instruction storage or programming device so that the generated signal adopts signal waveform characteristics selected in accordance with said set of instructions.

Claims

1. An apparatus for application of electrical stimulation to patients suffering from incontinence, said apparatus comprising, in combination:

generator means for providing a series of electrical stimulation pulses;

electrode means, responsive to said series of electrical stimulation pulses and sized for placement on a patient'"'"'s body, for stimulating a pudendal nerve of the patient in order to reduce patient incontinence, said electrode means comprising perineal surface electrode means, shaped for positioning on a perineal portion of a patient, for providing stimulation to dorsal and perineal branches of the patient'"'"'s pudendal nerve and sacral surface electrode means, shaped for fitting to a sacral region of said patient, for stimulating nerves in the sacral region; and

means for connecting said electrode means with said generator means.

2. The apparatus according to claim 1 wherein said perineal surface electrode means comprises a sheet electrode having an hour glass shape.

3. The apparatus according to claim 2 wherein said sacral surface electrode means comprises a sheet electrode having a shape of a generally truncated triangle.

4. The apparatus according to claim 3 wherein the sacral surface sheet electrode includes an apex plateau region and means, defining a dipped portion thereon, for facilitating finger placement of the sacral surface electrode over the sacral region.

5. The apparatus according to claim 3 further comprising indifferent electrode means for receiving electrical stimulation pulses from the generator means and balancing pulse geometry over a patient'"'"'s sacral plexus and means for connecting said indifferent electrode to said generator means.

6. The apparatus for application of electrical stimulation to patients suffering from incontinence according to claim 1 wherein the generator means for providing a series of electrical stimulation pulses produces a waveform having a pulse train of bi-phasic pulses, with a modulated envelope having a duration in the range of 100 to 1,000 microseconds, with N pulses per envelope being provided, N being between 1 and 1,000.

7. The apparatus according to claim 6 wherein the generator means provides the modulated envelope with a frequency selected from the group consisting of sequential, random and fixed frequencies of between 0.1 and 100 Hz.

8. The apparatus according to claim 7 wherein the generator means provides pulses in each envelope corresponding to a frequency of between 500 and 5,000 Hz.

9. A method for application of electrical stimulation to patients suffering from incontinence, said method comprising the steps of:

applying a perineal surface electrode to a perineal portion of a patient;

providing a series of electrical stimulation pulses to said perineal surface electrode in order to stimulate dorsal and perineal branches of the patient'"'"'s pudendal nerve;

applying a sacral surface electrode to a sacral region of said patient; and

providing a series of electrical stimulation pulses to said sacral surface electrode in order to stimulate nerves in the sacral region.

10. The method according to claim 9 further comprising the steps of:

applying an indifferent electrode to a patient'"'"'s buttocks; and

providing a series of electrical stimulation pulses to said indifferent electrode in order to provide balanced pulse geometry to the perineal and sacral surface electrodes.