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

• US 10,661,078 B2
• Filed: 12/22/2017
• Issued: 05/26/2020
• 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): Peffley, Michael F
• Assistant Examiner(s): Vahdat, Khadijeh A
• Application Number:
  US15/853,543
• Publication Number:
  US 20180133461A1
• Time in Patent Office: 886 Days
• 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 method to alleviate back pain, the method comprising:

placing at least two electrodes comprising a first electrode and a second electrode within a lower back of a human such that the first and second electrodes are implanted adjacent to tissue associated with at least one muscle supporting stability of the human'"'"'s spine;

electrically stimulating, via the first electrode, efferent nervous tissue associated with the at least one muscle to cause contraction of the at least one muscle to facilitate rehabilitation; and

electrically stimulating, via the second electrode, afferent nervous tissue associated with the at least one muscle to block pain signals resulting from electrically stimulating the efferent nervous tissue.

2. The method of claim 1, wherein placing the at least two electrodes comprises placing the first electrode adjacent to a medial branch of a dorsal ramus nerve, and

wherein electrically stimulating, via the first electrode, the efferent nervous tissue comprises electrically stimulating the medial branch of the dorsal ramus nerve to cause contraction of a multifidus muscle.

3. The method of claim 1, wherein placing the at least two electrodes comprises placing the second electrode adjacent to a peripheral nerve, and

wherein electrically stimulating, via the second electrode, the afferent nervous tissue comprises electrically stimulating the peripheral nerve to block the pain signals traveling towards the human'"'"'s brain from the human'"'"'s spinal cord.

4. The method of claim 1, wherein electrically stimulating, via the first electrode, the efferent nervous tissue improves muscle tone and neural drive.

5. The method of claim 1, wherein electrically stimulating, via the first electrode, the efferent nervous tissue causes a predetermined series of muscle contractions during a predetermined number of sessions.

6. The method of claim 5, wherein the predetermined number of sessions comprises one hour per day over a period of weeks.

7. The method of claim 1, wherein electrically stimulating, via the first electrode, comprises electrically stimulating at a stimulation rate between 10-30 Hz.

8. The method of claim 1, wherein electrically stimulating, via the first electrode, comprises increasing a stimulation pulse intensity of the electrical stimulation to a predetermined maximum value to elicit a desired muscle contraction, and ramping down the electrical stimulation applied via the first electrode.

9. The method of claim 1, wherein electrically stimulating, via the first electrode, comprises increasing a therapeutic dose of the electrical stimulation until a desired level is achieved, and decreasing the therapeutic dose of the electrical stimulation to zero.

10. The method of claim 9, wherein the therapeutic dose comprises a number of muscle contractions within a therapy period.

11. The method of claim 1, wherein electrically stimulating, via the second electrode, comprises electrically stimulating at a higher stimulation frequency than electrically stimulating via the first electrode.

12. The method of claim 1, wherein electrically stimulating via the first and second electrodes comprises simultaneously electrically stimulating via the first and second electrodes.

13. The method of claim 1, wherein electrically stimulating via the first and second electrodes comprises electrically stimulating via the first and second electrodes in a time-wise interleaved manner.

14. The method of claim 1, further comprising:

adjusting parameters for electrical stimulation; and

electrically stimulating, via the first or second electrode, at the adjusted parameters.

15. The method of claim 1, wherein placing the at least two electrodes comprises placing a lead having the at least two electrodes disposed thereon within the lower back of the human.

16. The method of claim 1, wherein placing the at least two electrodes comprises placing a first lead having the first electrode disposed thereon and a second lead having the second electrode disposed thereon within the lower back of the human.

17. The method of claim 1, further comprising electrically coupling the at least two electrodes to a pulse generator, wherein electrical stimulation via the first and second electrodes is based on an electrical stimulation regime programmed in the pulse generator.

18. The method of claim 17, wherein the pulse generator comprises a first circuitry module operatively coupled to the first electrode and a second circuitry module operatively coupled to the second electrode,

wherein electrically stimulating, via the first electrode, the efferent nervous tissue comprises electrically stimulating based on programming associated with the first circuitry module, and

wherein electrically stimulating, via the second electrode, the afferent nervous tissue comprises electrically stimulating based on programming associated with the second circuitry module.

19. The method of claim 17, further comprising implanting the pulse generator.

20. The method of claim 19, further comprising transmitting data associated with the pulse generator from the pulse generator to an external control system.

21. The method of claim 20, further comprising receiving power at the pulse generator from the external control system to charge a battery of the pulse generator.

22. The method of claim 20, further comprising transmitting data associated with the pulse generator from the pulse generator to a computer running monitoring and control software.