External pulse generator device and associated methods for trial nerve stimulation

• US 10,589,103 B2
• Filed: 09/28/2017
• Issued: 03/17/2020
• 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:
  US15/719,461
• Publication Number:
  US 20180117344A1
• Time in Patent Office: 901 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 seamless conversion to the permanently implanted system.

Claims

1. A neurostimulation system comprising:

an implantable neurostimulation lead having 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;

an external pulse generator electrically coupleable to the implantable neurostimulation lead, the external pulse generator being electrically coupled with the one or more neurostimulation electrodes when electrically coupled with the 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 one or more neurostimulation electrodes when implanted at a target location;

wherein the external pulse generator includes a single button, the button being configured to turn on the external pulse generator for delivery of the trial neurostimulation treatment, and wherein a housing of the external pulse generator lacks manual stimulation adjustment controls disposed thereon; and

an implantable pulse generator adapted to deliver a neurostimulation therapy through the one or more neurostimulation electrodes of the implantable neurostimulation lead based on the trial neurostimulation treatment, wherein the external pulse generator and the implantable pulse generator are configured to wirelessly couple with a patient remote, the patient remote being configured to control stimulation or monitor a battery status of the external pulse generator and the implantable pulse generator in a substantially same manner.

2. The system of claim 1 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.

3. The system of claim 1 wherein the implantable pulse generator includes a recharging coil and associated components for wireless charging through a skin of the patient while implanted, and the external pulse generator is of a substantially similar configuration of components as the implantable pulse generator but further includes a battery power source and lacks any recharging coil and associated components for wireless charging.

4. The system of claim 3, wherein the battery power source is configured to power the external pulse generator for a duration of a trial period, wherein the duration of the trial period is at least one week.

5. The system of claim 1, wherein the patient remote is configured to facilitate transition between a trial system and a permanent system, wherein the trial system corresponds to the external pulse generator and the permanent system corresponds to the implantable pulse generator.

6. The system of claim 1, further comprising a lead extension electrically coupled to the external pulse generator.

7. The system of claim 6, wherein the lead extension is hardwired with the external pulse generator.

8. The system of claim 6, wherein the lead extension is connected at one end to the proximal end of the implantable neurostimulation lead and coupleable at an opposite end to the external pulse generator or intervening connection.

9. The system of claim 1, further comprising an adherent patch adapted to adhere to a skin of the patient and support the external pulse generator on the skin of the patient for a duration of a trial period.

10. 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, wherein the external pulse generator includes a single button, the button being configured to turn on the external pulse generator, and wherein a housing of the external pulse generator lacks manual stimulation adjustment controls disposed thereon;

performing one or more trial neurostimulation treatments with the neurostimulation lead and the external pulse generator during a trial period;

implanting an implantable pulse generator and connecting to the neurostimulation lead implanted within the patient;

performing a neurostimulation treatment therapy with the implanted neurostimulation lead and the implantable pulse generator based on the one or more trial neurostimulation treatments performed with the external pulse generator; and

coupling the implantable pulse generator with a patient remote, wherein the patient remote is configured to control stimulation or monitor a battery status of the implantable pulse generator in a substantially same manner as the external pulse generator.

11. The method of claim 10, wherein performing the one or more trial neurostimulation treatments comprises powering the external pulse generator with a non-rechargeable, non-removable battery power source.

12. The method of claim 10, further comprising:

powering the external pulse generator with an attached battery, the external pulse generator lacking any recharging coil and components for wireless charging; 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.

13. The method of claim 10, wherein performing the one or more trial neurostimulation treatments comprises wirelessly coupling the external pulse generator with a patient remote.

14. The method of claim 13, wherein performing the one or more trial neurostimulation treatments further comprises adjusting stimulation applied by the external pulse generator with an adjustment control of the patient remote.

15. The method of claim 14, wherein performing the one or more trial neurostimulation treatments further comprises powering on the external pulse generator with the button on the external pulse generator and subsequently wirelessly coupling with the patient remote.

16. The method of claim 15, wherein any adjustment of stimulation of the external pulse generator is performed by the patient remote after coupling with the patient remote.

17. The method of claim 14, wherein the patient remote is configured to facilitate transition from a trial system to a permanently implanted system, wherein the trial system corresponds to the external pulse generator and the permanently implanted system corresponds to the implantable pulse generator.

18. The method of claim 10, wherein electrically coupling the neurostimulation lead to the external pulse generator comprises attaching the external pulse generator and lead through a lead extension.

19. The method of claim 18, wherein the lead extension is hardwired to the external pulse generator.