Systems and methods for implanting electrode leads for use with implantable neuromuscular electrical stimulator

• US 9,981,122 B2
• Filed: 11/12/2015
• Issued: 05/29/2018
• Est. Priority Date: 06/13/2012
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Rawat, Prashant Brijmohansingh, Demorett, Henry Thomas, Shiroff, Jason Alan
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/939,955
• Publication Number:
  US 20160067476A1
• Time in Patent Office: 929 Days
• Field of Search: 606129, 607116, 607117
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

A system of implanting electrode leads for restoring muscle function to the lumbar spine to treat low back pain is provided. The system provides efficient implantation of the leads, including the ability to verify deployment of anchoring mechanisms on the lead using an impedance assessment, such that the implanted lead may be secured within the patient and used to restore muscle function of local segmental muscles associated with the lumbar spine stabilization system.

Claims

1. A kit for implanting an electrode lead in a system for restoring muscle function to the lumbar spine, the kit comprising:

a sheath configured for insertion in a lower back of a patient, the sheath having a lumen extending therethrough, and a distal end having first and second windows spaced apart a predetermined distance;

a needle electrode having a distal end configured to be positioned in or adjacent to tissue associated with control of the lumbar spine through the lumen, the needle electrode having first and second electrodes configured to stimulate the tissue at an intensity and duration sufficient to cause an observable contraction of a muscle of the lower back to permit verification of needle electrode positioning, the first and second electrodes spaced apart the predetermined distance so that the first and second electrodes register with the first and second windows of the sheath to permit verification of needle electrode positioning while the needle electrode is disposed within the lumen;

a lead having proximal and distal electrodes spaced apart the predetermined distance and disposed in a distal region of the lead, the lead configured for implantation through the lumen to position the proximal and distal electrodes in or adjacent to the tissue associated with control of the lumbar spine at locations observed to cause muscle contraction via testing with the needle electrode; and

first and second oppositely-angled fixation elements coupled to the distal region of the lead, the first and second oppositely-angled fixation elements configured to transition from a contracted, delivery state to an expanded, deployed state to secure the lead in or adjacent to the tissue associated with control of the lumbar spine.

2. The kit of claim 1, wherein the first and second electrodes of the needle electrode are configured to stimulate the tissue through the first and second windows while the needle electrode is disposed within the lumen.

3. The kit of claim 2, wherein the window is sized and shaped to align with the first and second electrodes of the needle electrode or the proximal and distal electrodes of the lead or both.

4. The kit of claim 1, further comprising an implantable pulse generator configured to be coupled to the proximal and distal electrodes via the lead.

5. The kit of claim 1, wherein the distal end of the needle electrode comprises an end configured to minimize tissue damage during insertion.

6. The kit of claim 1, wherein the distal end of the needle electrode comprises a needle point configured to facilitate insertion of the needle electrode.

7. The kit of claim 1, wherein the needle electrode or the sheath or both comprise a radiopaque marker.

8. The kit of claim 1, wherein the distal end of the needle electrode is configured to be movable relative to a distal end of the sheath to permit verification of needle electrode positioning.

9. The kit of claim 1, wherein the needle electrode is coupled to an external computer, the external computer configured to cause the needle electrode to stimulate the tissue responsive to user input.

10. The kit of claim 1, wherein the lead comprises a stylet lumen, the stylet lumen configured to accept a stylet therein to provide additional stiffness to the lead during implantation.

11. The kit of claim 1, wherein the sheath comprises a handle sized and shaped to permit a physician to hold the sheath.

12. A method of implanting an electrode lead, the method comprising:

inserting a needle electrode having first and second electrodes disposed within a lumen of a sheath, the sheath having first and second windows spaced apart a predetermined distance so that the first and second electrodes register with the first and second windows of the sheath when a distal end of the needle electrode is positioned in or adjacent to tissue associated with control of the lumbar spine;

stimulating the tissue with the first and second electrodes of the needle electrode, exposed to the tissue via the first and second windows, at an intensity and duration sufficient to cause an observable contraction of a muscle of the lower back;

verifying placement of the distal end of the needle electrode at the tissue based on the observable contraction while the needle electrode is disposed within the lumen;

removing the needle electrode from the sheath;

inserting an electrode lead through the lumen of the sheath such that proximal and distal electrodes disposed on the lead are implanted in or adjacent to the tissue associated with control of the lumbar spine at locations observed to cause muscle contraction during stimulation via the needle electrode; and

removing the sheath to deploy first and second oppositely-angled fixation elements coupled to the electrode lead to secure the electrode lead in or adjacent to the tissue associated with control of the lumbar spine.

13. The method of claim 12, wherein a guidewire is not used for inserting the needle electrode or inserting the electrode lead.

14. The method of claim 12, further comprising stimulating the tissue with the proximal and distal electrodes to rehabilitate function of a multifidus muscle and improve spinal stability.

15. The method of claim 12, wherein stimulating the tissue with the first and second electrodes of the needle electrode is executed through the first and second windows.

16. The method of claim 12, further comprising moving the distal end of the needle electrode relative to the distal end of the sheath prior to stimulating the tissue with the needle electrode.

17. The method of claim 12, wherein at least one of the distal end of the needle electrode or the sheath has a radiopaque marker, and wherein verifying placement of the distal end of the needle electrode at the tissue comprises visualizing the radiopaque marker.

18. The method of claim 12, wherein the electrode lead has a stylet lumen, the method further comprising inserting a stylet through the stylet lumen to provide additional stiffness to the electrode lead.

19. The method of claim 12, further comprising adjusting the electrode lead relative to the sheath subsequent to implantation of the electrode lead.