External pulse generator device and associated methods for trial nerve stimulation

• US 9,802,051 B2
• Filed: 08/14/2015
• Issued: 10/31/2017
• Est. Priority Date: 08/15/2014
• Status: Active Grant

• Current Assignee: Axonics, Inc.
• Original Assignee: Axonics Modulation Technologies, Inc.
• Inventors: Mathur, Prabodh, Sama, Rinda, Schroeder, Dennis, Schmid, Eric, Karten, Stuart
• Primary Examiner(s): Tejani, Ankit D
• Application Number:
  US14/827,081
• Publication Number:
  US 20160045745A1
• Time in Patent Office: 809 Days
• Field of Search: None
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36107 Sexual dysfunction stimulating genital organs A61N1/36007
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings

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.

Claims

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, 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.

2. The system of claim 1, further comprising:

an adherent patch adapted to substantially cover the external pulse generator and adhere to a skin of the patient to support the external pulse generator on the skin of the patient for the duration of the trial period, wherein the external pulse generator is sealed within the patch so as to be water resistant.

3. The system of claim 2, wherein the adherent patch comprises a layer of a skin-compatible adhesive and a breathable tape having sufficient adhesive strength to support the external pulse generator on the skin of the patient continuously for the duration of the trial period.

4. The system of claim 3, wherein the duration of the trial period is at least one week.

5. The system of claim 1, further comprising a neurostimulation lead extension connected at one end to the proximal end of the implantable neurostimulation lead and coupleable with the external pulse generator.

6. The system of claim 5, wherein the implantable neurostimulation lead is of a length suitable for implantation within a fully implanted neurostimulation system without removal of the distal portion from the target location after the trial period, wherein in the fully implanted neurostimulation system, an implantable pulse generator is implanted in a lower back region.

7. The system of claim 5, wherein the lead extension is removably coupleable with the external pulse generator while supported in the patch on the skin of the patient.

8. The system of claim 5, wherein the lead extension is hardwired with the external pulse generator while sealed within an adherent patch.

9. The system of claim 1 further comprising:

an implantable pulse generator adapted to deliver the neurostimulation therapy through the implantable neurostimulation lead, wherein the external pulse generator is smaller and lighter than the implantable pulse generator.

10. The system of claim 9 wherein the implantable pulse generator includes a coil and associated components for wireless charging through the skin of the patient while implanted, and wherein the external pulse generator is of a substantially similar configuration of components as the implantable pulse generator but is modified to omit the coil and associated components for wireless charging and to include a battery source.

11. The system of claim 9 wherein the implantable pulse generator is configured to operate while implanted for one or more years, while the external pulse generator is configured to be disposable.

12. The system of claim 1, further comprising an implantable pulse generator configured for implantation, wherein the implantable pulse generator is wirelessly coupleable with the patient remote and adapted to effect adjustment of stimulation via the patient remote in the same manner as the external pulse generator.

13. A method of delivering a neurostimulation treatment, the method comprising:

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.

14. The method of claim 13, wherein the external pulse generator is smaller than the implantable pulse generator.

15. The method of claim 13, further comprising:

powering the external pulse generator with the battery; and

powering the implantable pulse generator with a power storage unit, the power storage unit being rechargeable through one or more wireless charging coils of the implantable pulse generator.

16. The method of claim 13, wherein electrically coupling the neurostimulation lead to the external pulse generator comprises attaching the external pulse generator and lead through a lead extension and securing the external pulse generator comprises coupling the adherent patch to a skin surface of the patient.

17. The method of claim 13, wherein performing one or more trial treatments comprises wirelessly communicating control instructions with a portable clinician programmer unit and recording the trial treatments delivered on a memory of the clinician programmer.

18. The method of claim 17, wherein performing the neurostimulation with the implantable pulse generator comprises wirelessly communicating control instructions with the portable clinician programmer, wherein the control instructions are determined or selected based on the trial treatments provided by the external pulse generator.

19. The method of claim 13, further comprising:

adjusting stimulation provided by the external pulse generator with the patient remote; and

adjusting stimulation provided by the implantable pulse generator with the patient remote.

20. The method of claim 19, wherein adjusting stimulation of the external pulse generator and adjusting stimulation of the implantable pulse generator is performed with the patient remote in the same manner.