Electromyographic lead positioning and stimulation titration in a nerve stimulation system for treatment of overactive bladder
First Claim
1. A method for improved positioning of an implantable lead in a patient in proximity of a sacral nerve so as to treat a bladder and/or bowel related dysfunction, wherein the implantable lead comprises at least four electrodes electrically coupled to an integrated electromyography (EMG) and stimulation clinician programmer, the method comprising:
- performing a sweeping cycle comprising;
delivering a test stimulation at a plurality of stimulation amplitude levels from the integrated clinician programmer to the sacral nerve tissue of the patient with a principal electrode of the implantable lead until a desired stimulation-induced EMG motor response is obtained that corresponds to the principal electrode being positioned in a target stimulation region adjacent the sacral nerve, wherein the principal electrode is selected from the at least four electrodes of the implantable lead;
recording the stimulation amplitude level at which the desired stimulation-induced EMG motor response is obtained with the principal electrode;
delivering test stimulations at a same stimulation amplitude level as the recorded stimulation amplitude level for a same period of time sequentially to each remaining electrode of the at least four electrodes of the implantable lead; and
simultaneously recording with the integrated clinician programmer a first stimulation-induced EMG motor response associated with a big toe of the patient and a second stimulation-induced EMG motor response associated with an anal bellows of the patient for the same level test stimulation on each electrode of the implantable lead during the sweeping cycle so as to facilitate positioning of the implantable lead at the target stimulation region along the sacral nerve; and
performing one or more subsequent sweeping cycles after lateral and/or axial adjustment of a position of the implantable lead based on the first and second stimulation-induced EMG motor responses simultaneously recorded during the last performed sweeping cycle until stimulation-induced EMG motor response recordings are indicative of multiple electrodes of the at least four electrodes being in the target region along the sacral nerve.
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Accused Products
Abstract
The present invention provides improved methods for positioning of an implantable lead in a patient with an integrated EMG and stimulation clinician programmer. The integrated clinician programmer is coupled to the implantable lead, wherein the implantable lead comprises at least four electrodes, and to at least one EMG sensing electrode minimally invasively positioned on a skin surface or within the patient. The method comprises delivering a test stimulation at a stimulation amplitude level from the integrated clinician programmer to a nerve tissue of the patient with a principal electrode of the implantable lead. Test stimulations are delivered at a same stimulation amplitude level for a same period of time sequentially to each of the four electrodes of the implantable lead. A stimulation-induced EMG motor response is recorded with the integrated clinician programmer for each test stimulation on each electrode of the implantable lead via the at least one pair of EMG sensing electrodes so as to facilitate initial positioning of the implantable lead at a target stimulation region.
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Citations
31 Claims
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1. A method for improved positioning of an implantable lead in a patient in proximity of a sacral nerve so as to treat a bladder and/or bowel related dysfunction, wherein the implantable lead comprises at least four electrodes electrically coupled to an integrated electromyography (EMG) and stimulation clinician programmer, the method comprising:
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performing a sweeping cycle comprising; delivering a test stimulation at a plurality of stimulation amplitude levels from the integrated clinician programmer to the sacral nerve tissue of the patient with a principal electrode of the implantable lead until a desired stimulation-induced EMG motor response is obtained that corresponds to the principal electrode being positioned in a target stimulation region adjacent the sacral nerve, wherein the principal electrode is selected from the at least four electrodes of the implantable lead; recording the stimulation amplitude level at which the desired stimulation-induced EMG motor response is obtained with the principal electrode; delivering test stimulations at a same stimulation amplitude level as the recorded stimulation amplitude level for a same period of time sequentially to each remaining electrode of the at least four electrodes of the implantable lead; and simultaneously recording with the integrated clinician programmer a first stimulation-induced EMG motor response associated with a big toe of the patient and a second stimulation-induced EMG motor response associated with an anal bellows of the patient for the same level test stimulation on each electrode of the implantable lead during the sweeping cycle so as to facilitate positioning of the implantable lead at the target stimulation region along the sacral nerve; and performing one or more subsequent sweeping cycles after lateral and/or axial adjustment of a position of the implantable lead based on the first and second stimulation-induced EMG motor responses simultaneously recorded during the last performed sweeping cycle until stimulation-induced EMG motor response recordings are indicative of multiple electrodes of the at least four electrodes being in the target region along the sacral nerve. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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Specification