Method and apparatus for stimulating a nerve of a patient

• US 8,046,082 B2
• Filed: 01/11/2010
• Issued: 10/25/2011
• 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:
  US12/685,557
• Publication Number:
  US 20100114259A1
• Time in Patent Office: 652 Days
• Field of Search: 607 1- 2, 607/32, 607/60, 607/63, 607115-116, 607/118
• US Class Current: 607/63
• 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 for a nerve stimulator include a status flag element such as a fuse, which is deliberately blown after use of the leads has begun to indicate that the leads are not to be reused. 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. 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.

Claims

1. An apparatus for stimulating a nerve of a patient through a plurality of leads disposed in a lead set and coupled to electrodes adapted to be applied to the patient, the lead set further having a status flag element and a plurality of leads coupled to the status flag element disposed therein, comprising:

a handheld control unit;

a connection site mounted in the control unit for receiving the lead set and providing electrical connections to the leads coupled to the electrodes and to the leads coupled to the status flag element;

a test mode control mechanism provided on the control unit for initiating test mode, wherein electronics in the control unit provides a test current to the electrical connections to the leads coupled to the electrodes for setting the test current at a final test current level based on response of the patient to stimulation of the nerve by the test current;

a therapy mode control mechanism provided on the control unit for initiating a therapy mode, wherein electronics in the control unit;

provides a therapy current to the electrical connections to the leads coupled to the electrodes, the therapy current initially having a level based on the final test current level; and

sets the status flag element to “

do not use”

through the electrical connections to the leads coupled to the status element flag, while the therapy current is being provided; and

circuitry in the control unit for detecting lead set status as indicated by the status flag element through the electrical connections to the leads coupled to the status flag element, and for disabling initiation of the therapy mode when the status flag element is set at “

do not use.”

2. The apparatus of claim 1 wherein:

the status flag element is a fuse;

electronics in the control unit applies a first voltage to the electrical connections to the leads coupled to the fuse while the therapy current is being provided, for blowing the fuse; and

circuitry in the control unit applies a second voltage to the electrical connections to the leads coupled to the fuse to detect when the fuse is blown and to disable initiation of the therapy mode when the fuse is blown.

3. The apparatus of claim 1 wherein the test mode control mechanism comprises:

a test mode button for initiating the test mode; and

a current adjustment button for setting the test current at the final test current level based on response of the patient to stimulation of the nerve by the test current.

4. The apparatus of claim 1 wherein the therapy mode control mechanism comprises:

a therapy mode button for initiating the therapy mode; and

a current adjustment button for varying the level of the therapy current during therapy mode.

5. The apparatus of claim 1 further comprising a current adjustment control mechanism, wherein:

the current adjustment control mechanism is effective during the test mode for varying the test current; and

the current adjustment control mechanism is effective during the therapy mode for varying the therapy current.