Lead set for nerve stimulator and method of operation thereof

• US 20080039915A1
• Filed: 05/17/2007
• Published: 02/14/2008
• Est. Priority Date: 10/18/2001
• Status: Active Grant

• Current Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Original Assignee: Uroplasty Incorporated (2941881 Canada, Inc.)
• Inventors: Williams, Jeffrey, Van Den Biggelaar, Johannes, Schauer, Anthony, Sandstrom, Paul, Herregraven, Marc
• Granted Patent: US 8,812,114 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3603 Control systems
• 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. A lead set for a nerve stimulator, comprising:

a keyed connector block having first, second, third and fourth conductors;

a first lead extending from the first conductor of the connector block and terminating in a patch electrode having adhesive on a surface thereof;

a second lead extending from the second conductor of the connector block and terminating in a needle clip; and

a fuse disposed in the connector block, the fuse being connected between the third and fourth conductors.

2. The lead set of claim 1, wherein the patch electrode is permanently connected to the first lead.

3. The lead set of claim 1, wherein the needle clip is permanently connected to the second lead.

4. The lead set of claim 1, wherein the first and second leads are merged in proximity to the connector block, and are separated away from the connector block.

5. The lead set of claim 1, wherein the connector block is plastic.

6. The lead set of claim 1, wherein the first conductor is electrically isolated from the second, third and fourth conductors.

7. The lead set of claim 1, wherein the second conductor is electrically isolated from the first, third and fourth conductors.

8. The lead set of claim 1, wherein the first, second, third and fourth conductors are female.

9. A lead set for a nerve stimulator, comprising:

a keyed connector block;

a first lead extending from the connector block and terminating in a patch electrode;

a second lead extending from the connector block and terminating in a needle clip; and

a fuse disposed in the connector block and electrically isolated from both the first lead and the second lead.

10. The lead set of claim 9, further comprising:

a first conductor electrically coupled to the first lead;

a second conductor electrically coupled to the second lead and electrically isolated from the first conductor;

a third conductor electrically isolated from both the first conductor and the second conductor; and

a fourth conductor electrically isolated from both the first conductor and the second conductor;

wherein the third conductor and the fourth conductor are electrically coupled by the fuse.

11. A lead set for a nerve stimulator, comprising:

a keyed connector block having first, second, third and fourth conductors;

a first lead extending from the first conductor of the connector block and terminating in a patch electrode having adhesive on a surface thereof;

a second lead extending from the second conductor of the connector block and terminating in a needle; and

a fuse disposed in the connector block, the fuse being connected between the third and fourth conductors.

12. A method for stimulating a nerve, comprising:

executing a test mode to determine an initial therapy current level;

executing a therapy mode to deliver a current to the nerve through a lead set having a status flag element, the current being initially set to the initial therapy current level; and

setting the status flag element in the lead set within a predetermined time after beginning execution of the therapy mode.

13. The method of claim 12, wherein:

the status flag element is a fuse; and

the setting step comprises blowing the fuse.

14. The method of claim 13, wherein the fuse is not in the electrical pathway of the current.

15. The method of claim 12, wherein the test mode comprises:

alternately increasing a test current and observing a 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.

16. The method of claim 15, wherein the test current is increased and decreased in increments of 0.5 mA.

17. The method of claim 12, wherein the therapy mode extends beyond the setting step.

18. The method of claim 17, wherein the therapy mode lasts for about 30 minutes.

19. A method for stimulating a nerve of a patient with therapy current, comprising:

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

entering a test mode;

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

exiting the test mode;

entering a therapy mode when the test mode is exited;

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

providing a therapy current through the lead set;

blowing the fuse within a predetermined time after entering therapy mode; and

exiting the therapy mode within a predetermined time after the fuse is blown.

20. The method of claim 19, wherein the test current adjustment during test mode comprises:

increasing the test current from an initial test current level of zero;

observing the patient while increasing the test current;

observing a patient response; and

decreasing the test current to the final test current level when the patient response is observed.

21. The method of claim 19, wherein the therapy current is initially set to the initial therapy current level and is adjustable throughout the therapy mode.