Method and Apparatus for Stimulating a Nerve of a Patient

• US 20100114259A1
• Filed: 01/11/2010
• Published: 05/06/2010
• 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.
• Granted Patent: US 8,046,082 B2
• Time in Patent Office: Days
• 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 are disclosed. The leads 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 (not conducting), then the stimulator assumes that the leads have already been used and does not enter therapy mode, and optionally may not enter test mode. If the fuse in the electrical leads is intact (conducting), or not blown, 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, although the user may not initiate another therapy mode (and optionally may not initiate another test mode) using the blown leads. Preferably the fuse is electrically isolated from the leads that contact the patient.

Claims

1. An apparatus for stimulating a nerve of a patient, comprising:

means for determining an initial therapy current level for the patient;

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

use”

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

means for changing the lead set to express a “

do not use”

status while the therapy current is being delivered and within a predetermined time after start of delivery thereof.

2. The apparatus of claim 1 wherein the initial therapy current level determining means comprises:

means for increasing a test current while awaiting a physical response from the patient;

means for decreasing the test current to a final test current level when the physical response occurs; and

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

3. The apparatus of claim 1, wherein:

the therapy current delivering means comprises means for delivering the therapy current continuously for about 30 minutes; and

the changing means comprises means for changing the lead set to express the “

do not use”

status at about one minute after the start of delivery of the therapy current.

4. The apparatus of claim 1, wherein:

the therapy current delivering means comprises means for delivering the therapy current continuously for about 30 minutes; and

the changing means comprises means for changing the lead set to express the “

do not use”

status at about two minutes after the start of delivery of the therapy current.

5. The apparatus of claim 1, wherein:

the therapy current delivering means comprises means for delivering the therapy current continuously for about 30 minutes; and

the changing means comprises means for changing the lead set to express the “

do not use”

status at about five minutes after the start of delivery of the therapy current.

6. An apparatus for stimulating a nerve of a patient through a plurality of leads disposed in a lead set and coupled to electrodes 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 single-use lead set and providing electrical connections to the leads coupled to the electrodes and to the leads coupled to the fuse;

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.”

7. The apparatus of claim 6 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.

8. The apparatus of claim 6 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.

9. The apparatus of claim 6 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.

10. The apparatus of claim 6 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.

11. An apparatus for stimulating a nerve of a patient through a lead set having a fuse, comprising:

means for activating a stimulator, the stimulator comprising a handheld controller coupled to a lead set having a fuse disposed therein;

means for entering a test mode;

means for adjusting a test current during test mode to set a final test current level;

means for exiting the test mode;

means for entering a therapy mode when the test mode is exited;

means for forming an initial therapy current level from the final test current level;

means for providing a therapy current through the lead set;

means for blowing the fuse within a predetermined time after entering therapy mode, while the therapy current is being provided through the lead set; and

means for exiting the therapy mode after the fuse is blown.

12. The apparatus of claim 11, wherein the test current adjusting means comprises:

means for increasing the test current from an initial test current level of zero; and

means for decreasing the test current to the final test current level when a patient response is observed while the test current is increasing.

13. The apparatus of claim 11, wherein the therapy current providing means comprises:

means for initially setting the therapy current at the final test current level; and

means for adjusting the therapy current level throughout the therapy mode.