External pulse generator device and associated methods for trial nerve stimulation
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.
1 . A neurostimulation pulse generator for delivering sacral neurostimulation therapy to a patient, the neurostimulation pulse generator configured to be positioned externally on the patient and comprising:
a housing;
circuitry disposed within the housing configured to: generate a plurality of electrical pulses for delivering a sacral neurostimulation treatment to a patient through one or more implanted neurostimulation electrodes coupled to the circuitry;
a single user-interface element disposed on an exterior of the housing, the user-interface element being configured to enable operation of the neurostimulation pulse generator;
wherein the housing lacks manual stimulation adjustment controls disposed thereon;
wherein the neurostimulation pulse generator is an external pulse generator configured to be disposable;
wherein a water-resistant cover encases only the neurostimulation pulse generator; and
wherein the water-resistant cover includes an opening for permitting access to a connection port located on the housing of the neurostimulation pulse generator, and wherein the opening is configured to permit a lead extension of an implantable neurostimulation lead to pass through the water-resistant cover and releasably connect to the neurostimulation pulse generator at the connection port.
2 . The neurostimulation pulse generator of claim 1 , wherein the one or more implanted neurostimulation electrodes are coupled to the circuitry via one or more conductors of the implantable neurostimulation lead.
3 . The neurostimulation pulse generator of claim 1 , further comprising a battery power source configured to power the neurostimulation pulse generator for a duration of a trial period, wherein the duration of the trial period does not exceed seven days.
4 . The neurostimulation pulse generator of claim 1 , wherein the lead extension is configured to be connected at one end to a proximal end of an implantable portion of the neurostimulation lead and coupleable at another end to the circuitry.
5 . The neurostimulation pulse generator of claim 1 , wherein the circuitry is configured to wirelessly couple the neurostimulation pulse generator to a patient remote.
6 . The neurostimulation pulse generator of claim 5 , wherein the lead extension is configured to be connected at one end to a proximal end of an implantable portion of the implantable neurostimulation lead and at another end to the circuitry.
7 . The neurostimulation pulse generator of claim 1 , wherein the circuitry is configured to wirelessly couple the neurostimulation pulse generator to a clinician programmer.
8 . The neurostimulation pulse generator of claim 1 , wherein the neurostimulation pulse generator includes a battery power source and lacks any recharging coil and associated components for wireless charging.
9 . A system for providing neurostimulation to a patient, the system comprising:
an external pulse generator configured to be mounted externally on the patient, wherein the external pulse generator is electrically coupleable to an implantable neurostimulation lead, wherein the external pulse generator is configured to generate a plurality of electrical impulses for delivering a trial neurostimulation treatment to a patient through the implantable neurostimulation lead when the implanted neurostimulation lead is implanted at a target location;
wherein the external pulse generator includes a single button, the single button being configured to enable the external pulse generator to deliver neurostimulation treatment;
wherein the implantable neurostimulation lead includes one or more conductors extending from a proximal end of the implantable neurostimulation lead to one or more neurostimulation electrodes disposed at or near a distal end of the implantable neurostimulation lead;
wherein a water-resistant cover encases only the external pulse generator; and
wherein the water-resistant cover includes an opening for permitting access to a connection port located on the housing of the neurostimulation pulse generator, and wherein the opening is configured to permit a lead extension of an implantable neurostimulation lead to pass through the water-resistant cover and releasably connect to the neurostimulation pulse generator at the connection port.
10 . The system of claim 9 , wherein the system includes a battery power source, and wherein the battery power source is configured to power the external pulse generator for up to seven days.
11 . The system of claim 9 , wherein the lead extension is connected at one end to the proximal end of an implantable portion of the implantable neurostimulation lead and coupleable at an opposite end to the external pulse generator.
12 . The system of claim 9 , wherein the water resistant cover comprises a patch adapted to adhere to a skin of the patient and retain the external pulse generator on the skin of the patient for a duration of a trial period.
13 . The system of claim 12 , wherein the patch is flexible.
14 . A system for providing sacral neurostimulation therapy to a patient on a trial basis, the system comprising:
a neurostimulation pulse generator configured to be positioned externally on the patient, wherein the neurostimulation pulse generator is encased by a water resistant cover and wherein the water resistant cover encases only the neurostimulation pulse generator; and
an implantable lead connected to the neurostimulation pulse generator and configured to deliver a plurality of electrical pulses to the patient's sacral nerve when the implantable lead is implanted in the patient;
wherein the neurostimulation pulse generator includes a housing enclosing circuitry, and wherein the circuitry is configured to generate the plurality of electrical pulses;
wherein the water-resistant cover is molded around a connection port located on the housing of the neurostimulation pulse generator, and wherein a lead extension of the implantable lead is electrically and releasably coupled to the external pulse generator at the connection port; and
wherein the implantable lead includes one or more conductors extending from a proximal end of the implantable lead, and wherein each of the conductors are connected to one or more neurostimulation electrodes disposed at or near a distal end of the implantable lead.
15 . The system of claim 14 , wherein the water resistant cover comprises a patch adapted to adhere to a skin of the patient and retain the neurostimulation pulse generator on the skin of the patient for a duration of a trial period.
16 . The system of claim 15 , wherein the patch is flexible.
17 . The system of claim 14 , wherein the lead extension is configured to be connected at one end to a proximal end of an implantable portion of the implantable neurostimulation lead and wherein the lead extension is connected at another end to the circuitry.
18 . A system for providing neurostimulation to a patient, the system comprising:
an external pulse generator configured to be mounted externally on the patient, wherein the external pulse generator is electrically coupleable to an implantable neurostimulation lead, wherein the external pulse generator is configured to generate a plurality of electrical impulses for delivering a trial neurostimulation treatment to a patient through the implantable neurostimulation lead when the implanted neurostimulation lead is implanted at a target location;
wherein the external pulse generator includes a single button, the single button being configured to turn off the external pulse generator;
wherein the implantable neurostimulation lead includes one or more conductors extending from a proximal end of the implantable neurostimulation lead to one or more neurostimulation electrodes disposed at or near a distal end of the implantable neurostimulation lead;
wherein a water-resistant cover encases the external pulse generator; and
wherein the water-resistant cover includes an opening for permitting access to a connection port located on the housing of the neurostimulation pulse generator designed to permit a lead extension of the implantable neurostimulation lead to pass through the water-resistant cover and releasably connect to the neurostimulation pulse generator at the connection port.