Modular stimulator for treatment of back pain, implantable RF ablation system and methods of use

• US 9,248,278 B2
• Filed: 03/10/2011
• Issued: 02/02/2016
• Est. Priority Date: 03/11/2010
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Crosby, Peter Andrew, Sachs, Dan, Rawat, Prashant Brijmohansingh, Shiroff, Jason Alan, Heemels, Johannes Petrus
• Primary Examiner(s): Hupczey, Ronald
• Assistant Examiner(s): VAHDAT, KHADIJEH A
• Application Number:
  US13/045,421
• Publication Number:
  US 20110224665A1
• Time in Patent Office: 1,790 Days
• Field of Search: 606/33, 606/34, 606/41, 606/46, 607 43- 48
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00221 with wireless transmission of data, e.g. by infrared radiation or radiowaves
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/124 switching the output to different electrodes, e.g. sequentially
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/06 for high-frequency therapy
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36042 of grafted tissue, e.g. skeletal muscle
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators

Abstract

Apparatus and methods for treating back pain are provided, in which an implantable stimulator is configured to communicate with an external control system, the implantable stimulator providing a neuromuscular electrical stimulation therapy designed to cause muscle contraction to rehabilitate the muscle, restore neural drive and restore spinal stability; the implantable stimulator further including one or more of a number of additional therapeutic modalities, including a module that provides analgesic stimulation; a module that monitors muscle performance and adjusts the muscle stimulation regime; and/or a module that provides longer term pain relief by selectively and repeatedly ablating nerve fibers. In an alternative embodiment, a standalone implantable RF ablation system is described.

Claims

1. A therapeutic electrical stimulation system comprising:

an implantable housing;

one or more electrode leads coupled to the implantable housing and having a plurality of electrodes, wherein at least one of the one or more electrode leads is configured to be implanted adjacent to a spinal tissue;

a first circuitry module disposed within the implantable housing and operatively coupled to at least one of the one or more electrode leads, wherein the first circuitry module is configured to deliver electrical stimulation to a selected first subset of the plurality of electrodes to cause contraction of a spinal muscle associated with the spinal tissue;

a second circuitry module, adapted for long term pain relief, disposed within the implantable housing and operatively coupled to at least one of the one or more electrode leads, wherein the second circuitry module is configured to perform a function selected from a group consisting of;

analgesic stimulation of afferent nerve fibers associated with the spinal tissue;

muscle performance monitoring;

stimulation of efferent nerve fibers associated with the spinal tissue to reduce spasm, and radio frequency (RF) ablation; and

a controller disposed within the implantable housing and operatively coupled to the first circuitry module and the second circuitry module, wherein the controller is configured to cause simultaneous delivery of the electrical stimulation via the first circuitry module and performance of the function via the second circuitry module.

2. The therapeutic electrical stimulation system of claim 1, wherein the controller is further configured to cause the first circuitry module to deliver the electrical stimulation and to cause the second circuitry module to perform the function selected from the group in an alternating manner or episodically.

3. The therapeutic electrical stimulation system of claim 1, further comprising a telemetry system disposed within the implantable housing and operatively coupled to the controller.

4. The therapeutic electrical stimulation system of claim 3, further comprising an external control system configured to wirelessly communicate with the telemetry system.

5. The therapeutic electrical stimulation system of claim 1, further comprising a power source disposed within the implantable housing.

6. The therapeutic electrical stimulation system of claim 5, further comprising an external control system configured to wirelessly transmit energy to the power source.

7. The therapeutic electrical stimulation system of claim 1, further comprising an electrode switching array disposed within the implantable housing, the controller operatively coupled to the electrode switching array to select the first subset of the plurality of electrodes coupled to the first circuitry module.

8. The therapeutic electrical stimulation system of claim 7, wherein the second circuitry is operatively coupled to a second subset of the plurality of electrodes, wherein the controller is configured to select the second subset of the plurality of electrodes coupled to the second circuitry module.

9. The therapeutic electrical stimulation system of claim 8, wherein the second subset of the plurality of electrodes utilizes different electrodes than the first subset of the plurality of electrodes.

10. The therapeutic electrical stimulation system of claim 1, wherein the second circuitry module is configured to perform analgesic stimulation of afferent nerve fibers associated with the spinal tissue and further comprising a third circuitry module configured to perform a function selected from a group consisting of:

muscle performance monitoring, stimulation of efferent nerve fibers associated with the spinal tissue to reduce spasm, and RF ablation.

11. The therapeutic electrical stimulation system of claim 1, wherein the second circuitry module is configured to perform the muscle performance monitoring, by measuring the muscle performance and to adjust the delivery of electrical stimulation by the first circuitry responsive to measured muscle performance.

12. The therapeutic electrical stimulation system of claim 1, wherein the second circuitry module is configured to perform the muscle performance monitoring using bioimpedance.

13. The therapeutic electrical stimulation system of claim 1, wherein the second circuitry module is configured to perform the muscle performance monitoring using electromyography.

14. The therapeutic electrical stimulation system of claim 1, wherein the second circuitry module is configured to perform the muscle performance monitoring using data indicative of mechanical motion.

15. The therapeutic electrical stimulation system of claim 1, further comprising an accelerometer disposed within the implantable housing and operatively coupled to the controller, wherein the accelerometer is configured to provide orientation data of the implantable housing to the controller.