Electrical stimulator for treatment of back pain and methods of use

• US 9,861,811 B2
• Filed: 09/09/2015
• Issued: 01/09/2018
• 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
• Assistant Examiner(s): VAHDAT, KHADIJEH A
• Application Number:
  US14/849,478
• Publication Number:
  US 20150374992A1
• Time in Patent Office: 853 Days
• Field of Search: 606 33- 41, 607 45, 607101-113
• 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 electrical stimulation therapy is designed to cause muscle contraction to rehabilitate the muscle, restore neural drive and restore spinal stability. In accordance with one aspect, electrical stimulation is applied through at least one electrode to stimulate efferent motor nerve fibers to cause muscle contraction to facilitate rehabilitation without targeting stimulation of afferent nerve fibers. In accordance with another aspect, a stimulator further includes 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.

Claims

1. A method to alleviate back pain, the method comprising:

placing at least one electrode within a tissue of a human such that the at least one electrode is implanted adjacent to efferent motor nerve fibers of at least one muscle supporting spinal stability of the human, and

applying electrical stimulation through the at least one electrode at a stimulation rate between 10-30 Hz to stimulate the efferent motor nerve fibers of the at least one muscle to cause contraction of the at least one muscle to facilitate rehabilitation without targeting stimulation of afferent nerve fibers.

2. The method of claim 1, further comprising:

implanting at least one implantable pulse generator operatively coupled with the at least one electrode within the human having back pain, wherein the electrical stimulation is applied based on an electrical stimulation regime programmed in the at least one implantable pulse generator.

3. The method of claim 2, wherein the at least one implantable pulse generator further is programmed to cause direct stimulation of the at least one muscle.

4. The method of claim 2, wherein the at least one implantable pulse generator is programmed to cause direct stimulation of at least one nerve innervating the at least one muscle.

5. The method of claim 2, wherein the at least one implantable pulse generator is programmed to ramp up and ramp down a strength and duration of the electrical stimulation.

6. The method of claim 2, further comprising wirelessly communicating with the at least one implantable pulse generator.

7. The method of claim 2, wherein the at least one electrode is hardwired through at least one lead to the at least one implantable pulse generator.

8. The method of claim 1, wherein placing the at least one electrode comprises placing the at least one electrode within the at least one muscle located at a level selected from a group consisting of:

sacral, lumbar, thoracic and cervical levels.

9. The method of claim 1, wherein applying the electrical stimulation causes contraction of the at least one muscle selected from a group consisting of:

longissimus, iliocostalis, spinalis, and multifidus.

10. The method of claim 1, wherein applying the electrical stimulation causes contraction of the at least one muscle to enhance muscle tone.

11. The method of claim 1, wherein the electrical stimulation causes contraction by reflex activation.

12. The method of claim 1, wherein applying the electrical stimulation comprises applying the electrical stimulation to at least one nerve selected from a group consisting of:

dorsal root of spinal nerve, ventral root of spinal nerve, and dorsal root ganglion.

13. The method of claim 1, wherein placing the at least one electrode further comprises placing a lead having the at least one electrode disposed thereon.

14. The method of claim 13, wherein placing the lead comprises percutaneously placing the lead.

15. The method of claim 13, wherein placing the lead comprises implanting the lead in the tissue of the human.

16. The method of claim 1, wherein the electrical stimulation stimulating the efferent motor nerve fibers of the at least one muscle is applied for a treatment period.

17. The method of claim 16, wherein the treatment period is repeated over a period of a few weeks.

18. The method of claim 16, wherein the treatment period is selected to provide extended back pain relief.

19. The method of claim 18, wherein the treatment period is selected to provide extended back pain relief for no less than a period of time approximately a same length as the treatment period.

20. The method of claim 1, wherein the electrical stimulation is applied for a prescribed period of time.

21. The method of claim 20, wherein the prescribed period of time is approximately one hour per day over a period of a few weeks.

22. The method of claim 1, further comprising evaluating the electrical stimulation by identifying a target muscle.

23. The method of claim 1, further comprising positioning the at least one electrode at a location based on a target muscle location.

24. The method of claim 23, further comprising:

placing at least one other electrode at a location different from the at least one electrode,

applying electrical stimulation through the at least one other electrode positioned at the different location; and

modifying the electrical stimulation based on at least one muscle characteristic resulting from the electrical stimulation through the at least one other electrode positioned at the different location.

25. The method of claim 24, wherein modifying the electrical stimulation comprises adjusting electrical stimulation parameters.

26. The method of claim 25, wherein the electrical stimulation parameters are selected from a group consisting of:

frequency, pulse duration, amplitude, duty cycle, pattern of stimulus pulses, polarity, number of phases, and waveform shape.