External pulse generator device and associated methods for trial nerve stimulation
First Claim
1. A neurostimulation system comprising:
- an implantable neurostimulation lead having one or more conductors disposed within a lead body, the one or more conductors extending from a proximal end of the lead to one or more neurostimulation electrodes disposed at or near a distal end of the lead; and
an external pulse generator electrically coupleable to the implantable lead, the external pulse generator being electrically coupled with the one or more neurostimulation electrodes when electrically coupled with the implantable lead, the external pulse generator being configured to generate a plurality of electrical impulses for delivering a neurostimulation treatment to a patient through the one or more neurostimulation electrodes when implanted at a target location,wherein the external pulse generator is configured for external use and adapted to be worn by the patient for a duration of a trial period to assess efficacy of the neurostimulation treatment,wherein the external pulse generator includes a battery for powering operation of the external pulse generator for the duration of the trial period, wherein the battery is non-rechargeable and non-removable by the patient, andwherein the external pulse generator includes a single button, the button being configured to turn on battery-powered operation of the external pulse generator for delivery of the neurostimulation treatment during the trial period, and the external pulse generator lacks manual stimulation adjustment controls disposed thereon, the external pulse generator being configured to wirelessly couple with a patient remote to facilitate adjustment of stimulation by the patient.
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Accused Products
Abstract
Systems and methods for providing a trial neurostimulation to a patient for assessing suitability of a permanently implanted neurostimulation are provided herein. In one aspect, a trial neurostimulation system includes an EPG patch adhered to a skin surface of a patient and connected to a lead extending through a percutaneous incision to a target tissue location. The EPG may be a modified version of the IPG used in the permanent system, the EPG may be smaller and/or lighter than the corresponding IPG device. The EPG and a lead extension may be sealed to allow improved patient mobility and reduced risk of infection. The EPG may be compatible with wireless systems used to control and monitor the IPG such that operation and control of the EPG is substantially the same in each system to allow seemless conversion to the permanently implanted system.
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Citations
20 Claims
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1. A neurostimulation system comprising:
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an implantable neurostimulation lead having one or more conductors disposed within a lead body, the one or more conductors extending from a proximal end of the lead to one or more neurostimulation electrodes disposed at or near a distal end of the lead; and an external pulse generator electrically coupleable to the implantable lead, the external pulse generator being electrically coupled with the one or more neurostimulation electrodes when electrically coupled with the implantable lead, the external pulse generator being configured to generate a plurality of electrical impulses for delivering a neurostimulation treatment to a patient through the one or more neurostimulation electrodes when implanted at a target location, wherein the external pulse generator is configured for external use and adapted to be worn by the patient for a duration of a trial period to assess efficacy of the neurostimulation treatment, wherein the external pulse generator includes a battery for powering operation of the external pulse generator for the duration of the trial period, wherein the battery is non-rechargeable and non-removable by the patient, and wherein the external pulse generator includes a single button, the button being configured to turn on battery-powered operation of the external pulse generator for delivery of the neurostimulation treatment during the trial period, and the external pulse generator lacks manual stimulation adjustment controls disposed thereon, the external pulse generator being configured to wirelessly couple with a patient remote to facilitate adjustment of stimulation by the patient. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A method of delivering a neurostimulation treatment, the method comprising:
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implanting a distal end of a neurostimulation lead in a target location in a patient, the distal end of the neurostimulation lead having one or more neurostimulation electrodes; electrically coupling the neurostimulation lead to an external pulse generator, the external pulse generator having a single button and a battery for powering the external pulse generator during a trial period, the battery being non-rechargeable and non-removable by the patient; turning on the external pulse generator for battery-powered operation by manually operating the button disposed on the external pulse generator; securing the external pulse generator to the patient with a belt or by coupling an adherent patch or tape to an outer skin surface of the patient; wirelessly coupling a patient remote with the external pulse generator to facilitate adjustment of stimulation provided by the external pulse generator by the patient, the external pulse generator lacking manual stimulation adjustment buttons disposed thereon; performing one or more trial treatments with the partly implanted lead and attached external pulse generator for a trial period; implanting an implantable pulse generator and connecting it to the permanently implantable lead entirely within the patient; and performing a neurostimulation treatment with the implanted lead and implantable pulse generator based on the one or more trial treatments with the external pulse generator. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20)
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Specification