IP Library Granted Patent US 9,248,278
Granted Patent B2
US 9,248,278 · App. 13/045,421 · Granted Feb 2, 2016

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

Inventors: Peter Andrew Crosby (Minneapolis, MN); Dan Sachs (Minneapolis, MN); Prashant Brijmohansingh Rawat (Blaine, MN); Jason Alan Shiroff (Edina, MN); Johannes Petrus Heemels (Keerbergen, BE)
Assignee: Mainstay Medical Limited
A61N1/0551A61B18/1492A61N1/06A61N1/36071A61B2017/00221A61B2018/00339A61B2018/00577A61B2018/124A61B2018/1467A61B2019/5248A61N1/36042
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Quick Facts
Patent No.
US 9,248,278
App. No.
13/045,421
Granted
Feb 2, 2016
Kind
B2
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 (20)

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.

Assignments (7)
RELEASE OF SECURITY INTEREST Recorded Mar 3, 2025
From: MADRYN FUND ADMINISTRATION, LLC
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 070388/0062 →
SECURITY INTEREST Recorded Jan 24, 2024
From: MADRYN HEALTH PARTNERS II (CAYMAN MASTER), LP
To: MADRYN FUND ADMINISTRATION, LLC
Reel/Frame 066367/0608 →
RELEASE OF SECURITY INTEREST Recorded Sep 14, 2022
From: OXFORD FINANCE LLC
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 061433/0238 →
SECURITY INTEREST Recorded Sep 9, 2022
From: MAINSTAY MEDICAL LIMITED
To: MADRYN HEALTH PARTNERS II (CAYMAN MASTER), LP
Reel/Frame 061404/0708 →
SECURITY INTEREST Recorded Apr 6, 2021
From: MAINSTAY MEDICAL LIMITED
To: OXFORD FINANCE LLC
Reel/Frame 055832/0744 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 10, 2012
From: MAINSTAY MEDICAL, INC.
To: MAINSTAY MEDICAL LIMITED
Reel/Frame 029104/0239 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 25, 2011
From: CROSBY, PETER ANDREW; SACHS, DAN; RAWAT, PRASHANT BRIJMOHANSINGH; SHIROFF, JASON ALAN; HEEMELS, JOHANNES PETRUS
To: MAINSTAY MEDICAL, INC.
Reel/Frame 026176/0825 →
Continuity (1)
Related Publication 20110224665A1 · Sep 15, 2011