Lead set for nerve stimulator and method of operation thereof
Single-use electrical leads for a nerve stimulator are disclosed. 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. Preferably the fuse is electrically isolated from the leads that contact the patient.
1. A lead set for a nerve stimulator having a one-way fit connection site, comprising:
a one-way fit connector configured to mate with the one-way fit connection site;
a first lead extending from the connector and terminating in a transcutaneous electrode;
a second lead extending from the connector and terminating in a percutaneous needle attachment member;
a status flag disposed in the connector, the status flag having functional status that is changeable during delivery of therapy after a pre-determined time period from an operational condition to a non-operational condition wherein the non-operational condition does not prevent continued delivery of said therapy;
a third lead disposed in the connector and connected to the status flag; and a fourth lead disposed in the connector and connected to the status flag;
wherein the first, second, third and fourth leads are bundled together at the connector;
wherein the first lead and the second lead are electrically isolated from one another; and
wherein the status flag and the third and fourth leads are electrically isolated from both the first lead and the second lead.
2. The lead set of claim 1 wherein the status flag element is a fuse, the functional status of the fuse being changeable by blowing the fuse, and being electronically determinable by applying a voltage thereto to sense whether the fuse is blown.
3. The lead set of claim 1 wherein the status flag element is a digital memory, the functional status of the digital memory being changeable by writing to the memory, and being electronically determinable by reading the memory.
4. The lead set of claim 1 wherein the status flag element is a digital potentiometer, the functional status of the digital potentiometer being changeable by varying a resistance thereof, and being electronically determinable by sensing the resistance thereof.
5. The lead set of claim 1 wherein the percutaneous needle attachment member comprises an electrically conductive tape member having an adhesive portion.
6. The lead set of claim 1 wherein the percutaneous needle attachment member comprises a percutaneous needle clip.