Method and apparatus for stimulating a nerve of a patient

• US 7,668,598 B2
• Filed: 05/17/2007
• Issued: 02/23/2010
• Est. Priority Date: 05/18/2006
• Status: Active Grant

• Current Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Original Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Inventors: Sandstrom, Paul Edward, Herregraven, Marc M., Schauer, Anthony W.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US11/804,137
• Publication Number:
  US 20080033510A1
• Time in Patent Office: 1,013 Days
• Field of Search: 607 1- 2, 607/46, 607 48- 49, 607/63, 607/108
• US Class Current: 607/48
• CPC Class Codes: A61B 2090/0814 Preventing re-use
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

Single-use electrical leads include a status flag element such as a fuse. The nerve stimulator has a “test mode” that determines a current value for treatment, and a “therapy mode” that administers treatment with the chosen current value. If the fuse in the electrical leads is blown, then the stimulator assumes that the leads have already been used and does not enter therapy mode, and optionally test mode. If the fuse in the electrical leads is intact, then the stimulator assumes that the leads are as yet unused, and allows the user to enter either test mode or therapy mode. The fuse is deliberately blown after a particular amount of time spent in therapy mode. After the fuse is blown, the user may still complete the therapy mode, even though the fuse is non-conducting. Preferably the fuse is electrically isolated from the leads that contact the patient.

Claims

1. A method for stimulating a posterior tibial nerve of a patient, comprising:

determining an initial therapy current level for the patient;

delivering a therapy current to the nerve through a lead set initially expressing a “

use”

status, the therapy current being initially set to the initial therapy current level; and

changing the lead set to express a “

do not use”

status within a predetermined time after start of the therapy current delivering step;

wherein the therapy current delivering step extends beyond the changing step.

2. The method of claim 1 wherein the initial therapy current level determining step comprises:

alternately increasing a test current and observing the patient for a physical response;

observing the physical response from the patient;

decreasing the test current to a final test current level; and

setting the initial therapy current level equal to the final test current level.

3. The method of claim 2, wherein the test current is increased and decreased in increments of 0.5 mA.

4. The method of claim 1, wherein:

the therapy current delivering step extends for about 30 minutes after start of the of the therapy current delivering step; and

the changing step occurs at about one minute after start of the of the therapy current delivering step.

5. The method of claim 1, wherein:

the therapy current delivering step extends for about 30 minutes after start of the of the therapy current delivering step; and

the changing step occurs at about two minutes after start of the of the therapy current delivering step.

6. The method of claim 1, wherein:

the therapy current delivering step extends for about 30 minutes after start of the of the therapy current delivering step; and

the changing step occurs at about five minutes after start of the of the therapy current delivering step.