Lead set for nerve stimulator and method of operation thereof

摘要

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.

主权项

1. A lead set for a nerve stimulator having a one-way fit connection site, comprising:
a one-way fit plastic connector configured to mate with the one-way fit connection site; a transcutaneous electrode; a first lead extending from the connector and terminating in the transcutaneous electrode; an attachment member for removably receiving a percutaneous needle electrode; a second lead extending from the connector and terminating in the attachment member; a fuse disposed entirely in the connector, said fuse including a 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 entirely in the connector and connected to the fuse; and a fourth lead disposed entirely in the connector and connected to the fuse; wherein the first lead and the second lead are electrically isolated from one another and physically separated at the transcutaneous electrode and the attachment member; and wherein the fuse and the third and fourth leads are electrically isolated from both the first lead and the second lead; and wherein the non-operational condition of the fuse is configured to prevent re-use of the lead set after delivery of the initial therapy.