Method and Apparatus for Stimulating a Nerve of a Patient
First Claim
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.
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Accused Products
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.
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Citations
13 Claims
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1. An apparatus for stimulating a nerve of a patient, comprising:
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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; andmeans 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. - View Dependent Claims (2, 3, 4, 5)
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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:
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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; andcircuitry 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.” - View Dependent Claims (7, 8, 9, 10)
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11. An apparatus for stimulating a nerve of a patient through a lead set having a fuse, comprising:
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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. - View Dependent Claims (12, 13)
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Specification