External Pulse Generator Device and Associated Methods for Trial Nerve Stimulation

• US 20160045745A1
• Filed: 08/14/2015
• Published: 02/18/2016
• 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
• Granted Patent: US 9,802,051 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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;

an external pulse generator electrically coupleable to the implantable lead, the pulse generator being electrically coupled with the one or more neurostimulation electrodes when electrically coupled with the implantable lead, wherein the pulse generator is 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; and

an adherent patch adapted to substantially cover the external pulse generator and adhere to a skin of the patient so as to support the external pulse generator on the skin of the patient for a duration of a trial period to assess efficacy of the neurostimulation treatment.

2. The system of claim 1, wherein the adherent patch comprises a flexible laminated patch, wherein the external pulse generator is sealed within the laminated patch so as to be water resistant.

3. The system of claim 1, wherein the adherent patch comprises a layer of a skin-compatible adhesive and/or breathable tape having sufficient adhesive strength to support the EPG 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, the implantable pulse generator is implanted in a lower back region.

7. The system of claim 5, wherein the lead extension connects to the proximal end of the neurostimulation lead at a removable connector, wherein the lead extension of sufficient length so as to position the patch supporting the external pulse generator at a desired location on the patient while the distal end is positioned at the target location.

8. The system of claim 7, wherein desired location for placement of the patch supporting the external pulse generator is skin surface region of the patient near the patient'"'"'s waistline.

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

10. The system of claim 7, wherein the lead extension is hardwired with the external pulse generator while sealed within the adherent patch.

11. 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/or lighter than the implantable pulse generator.

12. The system of claim 11 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.

13. The system of claim 11 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.

14. The system of claim 11 further comprising an anchor coupled with the lead body and having a plurality of tines extending from the helical body, wherein each of the plurality of tines is biased toward a deployed configuration, wherein in the deployed configuration, the plurality of tines extend laterally away from longitudinal axis when the helical body is disposed thereon, and the plurality of tines are resiliently deflectable toward a delivery configuration in which the plurality of tines are folded inward toward the longitudinal axis to facilitate delivery of the neurostimulation lead during implantation while the plurality of tines are constrained by an outer sheath.

15. 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;

securing the external pulse generator by coupling an adherent patch or a belt supporting the external pulse generator to an outer skin surface of the patient;

performing one or more trial treatments with the partly implanted lead and attached external pulse generator for a trial period;

replacing the partly implanted lead with a permanently implanted lead;

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.

16. The method of claim 15, wherein the external pulse generator is smaller than the implantable pulse generator.

17. The method of claim 15, further comprising:

powering the external pulse generator with an attached 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.

18. The method of claim 15, wherein electrically coupling the neurostimulation lead to the external pulse generator comprising 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.

19. The method of claim 15, further comprising:

securing the partly implanted lead in position with one or more additional adherent pads covering the percutaneous incision through which the partly implanted lead extends and/or excess lead and securing the one or more additional adherent patches to the patient'"'"'s skin.

20. The method of claim 15, 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.

21. The method of claim 20, 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.