Systems and methods for enhanced implantation of electrode leads between tissue layers

• US 10,327,810 B2
• Filed: 07/05/2016
• Issued: 06/25/2019
• Est. Priority Date: 07/05/2016
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Shiroff, Jason Alan, Demorett, Henry, Beck, John, Hauschild, Sidney
• Primary Examiner(s): Holwerda, Kathleen S
• Application Number:
  US15/202,485
• Publication Number:
  US 20180008311A1
• Time in Patent Office: 1,085 Days
• Field of Search: 606129
• 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 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 2018/00339 Spine, e.g. intervertebral disc
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

Systems and methods for enhanced implantation of an electrode lead for neuromuscular electrical stimulation of tissue associated with control of the lumbar spine for treatment of back pain, in a midline-to-lateral manner are provided. 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 without disruption of the electrode lead post-implantation due to anatomical structures.

Claims

1. A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:

selecting a guide needle having a longitudinal axis and a distal tip;

selecting a lead having a distal region including one or more electrodes;

locating a target vertebrae of the lumbar spine;

inserting the distal tip of the guide needle percutaneously at a first insertion site a lateral distance from a midline of the target vertebrae to a depth;

measuring the depth attained by the distal tip of the guide needle;

locating a second insertion site along the midline of the target vertebrae based on the depth, the second insertion site located a distance from the first insertion site approximately equal to the depth; and

implanting the lead at the second insertion site with the distal region angled relative to the longitudinal axis of the guide needle, so that the lead traverses naturally occurring fascicle planes and the one or more electrodes are disposed in or adjacent to a tissue associated with control of the lumbar spine.

2. The method of claim 1, wherein locating the target vertebrae comprises locating an L3 vertebrae.

3. The method of claim 1, wherein the first insertion site is located at a cranial edge of a transverse process of the target vertebrae and proximately lateral to a base of a superior articular process of the target vertebrae.

4. The method of claim 1, wherein the second insertion site is located above an L4 spinous process.

5. The method of claim 1, wherein the one or more electrodes are disposed in or adjacent to a dorsal ramus nerve or fascicles thereof.

6. The method of claim 1, further comprising implanting an implantable pulse generator configured to be coupled to the lead.

7. The method of claim 1, wherein implanting the lead at the second insertion site comprises:

selecting a delivery needle having a distal tip, a lumen and a longitudinal axis;

inserting the distal tip of the delivery needle percutaneously at the second insertion site such that the longitudinal axis of the delivery needle is angled relative to the longitudinal axis of the guide needle;

advancing a guidewire through the lumen of the delivery needle;

removing the delivery needle;

advancing an introducer assembly over the guidewire;

removing the guidewire;

advancing the lead through the introducer assembly so that the one or more electrodes are disposed in or adjacent to the tissue associated with control of the lumbar spine; and

retracting the introducer assembly.

8. The method of claim 7, wherein the longitudinal axis of the delivery needle is approximately angled 45 degrees relative to the longitudinal axis of the guide needle.

9. The method of claim 7, wherein inserting the distal tip of the delivery needle further comprises visualizing the distal tip of the delivery needle within an outline of a neural foramen of the target vertebrae.

10. The method of claim 7, wherein inserting the distal tip of the delivery needle further comprises advancing the distal tip of the delivery needle approximately 3-5 mm beyond the distal tip of the guide needle, thereby penetrating an intertransversarii.

11. The method of claim 7, further comprising removing the guide needle after inserting the distal tip of the delivery needle percutaneously at the second insertion site.

12. The method of claim 7, wherein advancing the introducer assembly over the guidewire further comprises visualizing a distal tip of the introducer assembly within an outline of a neural foramen of the target vertebrae to confirm placement of the introducer assembly within a plane of an intertransversarii.

13. The method of claim 7, wherein the lead comprises one or more fixation elements disposed in proximity to at least one of the one or more electrodes, the one or more fixation elements configured to transition from a delivery state, wherein the one or more fixation elements are positioned adjacent to the at least one of the one or more electrodes, to a deployed state, wherein the one or more fixation elements are spaced apart from the at least one of the one or more electrodes and positioned to anchor the lead to an anchor site,

wherein retracting the introducer assembly causes the one or more fixation elements to transition from the delivery state to the deployed state.

14. The method of claim 7, wherein the introducer assembly comprises a dilator having a lumen extending therethrough configured to receive the guidewire, and an introducer sheath having a lumen extending therethrough configured to receive the dilator, the method further comprising removing the dilator prior to advancing the lead through the introducer assembly.

15. A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:

selecting a guide needle having a longitudinal axis and a distal tip;

selecting a lead having a distal region including one or more electrodes;

locating a target vertebrae of the lumbar spine;

inserting the distal tip of the guide needle percutaneously at a first insertion site a lateral distance from a midline of the target vertebrae to a depth, the first insertion site located at a superior articular process of the target vertebrae;

locating a second insertion site along the midline of the target vertebrae based on the depth; and

implanting the lead at the second insertion site with the distal region angled relative to the longitudinal axis of the guide needle, so that the lead traverses naturally occurring fascicle planes and the one or more electrodes are disposed in or adjacent to a tissue associated with control of the lumbar spine.

16. The method of claim 15, wherein locating the target vertebrae comprises locating an L3 vertebrae.

17. The method of claim 15, further comprising measuring the depth attained by the distal tip of the guide needle, the second insertion site located a distance from the first insertion site approximately equal to the depth.

18. The method of claim 15, wherein the second insertion site is located above an L4 spinous process.

19. The method of claim 15, wherein the one or more electrodes are disposed in or adjacent to a dorsal ramus nerve or fascicles thereof.

20. The method of claim 15, further comprising implanting an implantable pulse generator configured to be coupled to the lead.

21. The method of claim 15, wherein implanting the lead at the second insertion site comprises:

selecting a delivery needle having a distal tip, a lumen and a longitudinal axis;

inserting the distal tip of the delivery needle percutaneously at the second insertion site such that the longitudinal axis of the delivery needle is angled relative to the longitudinal axis of the guide needle;

advancing a guidewire through the lumen of the delivery needle;

removing the delivery needle;

advancing an introducer assembly over the guidewire;

removing the guidewire;

advancing the lead through the introducer assembly so that the one or more electrodes are disposed in or adjacent to the tissue associated with control of the lumbar spine; and

retracting the introducer assembly.

22. The method of claim 21, wherein the longitudinal axis of the delivery needle is approximately angled 45 degrees relative to the longitudinal axis of the guide needle.

23. The method of claim 21, wherein inserting the distal tip of the delivery needle further comprises visualizing the distal tip of the delivery needle within an outline of a neural foramen of the target vertebrae.

24. The method of claim 21, Wherein inserting the distal tip of the delivery needle further comprises advancing the distal tip of the delivery needle approximately 3-5 mm beyond the distal tip of the guide needle, thereby penetrating an intertransversarii.

25. The method of claim 21, further comprising removing the guide needle after inserting the distal tip of the delivery needle percutaneously at the second insertion site.

26. The method of claim 21, wherein advancing the introducer assembly over the guidewire further comprises visualizing a distal tip of the introducer assembly within an outline of a neural foramen of the target vertebrae to confirm placement of the introducer assembly within a plane of an intertransversarii.

27. The method of claim 21, wherein the lead comprises one or more fixation elements disposed in proximity to at least one of the one or more electrodes, the one or more fixation elements configured to transition from a delivery state, wherein the one or more fixation elements are positioned adjacent to the at least one of the one or more electrodes, to a deployed state, wherein the one or more fixation elements are spaced apart from the at least one of the one or more electrodes and positioned to anchor the lead to an anchor site,

wherein retracting the introducer assembly causes the one or more fixation elements to transition from the delivery state to the deployed state.

28. The method of claim 21, wherein the introducer assembly comprises a dilator having a lumen extending therethrough configured to receive the guidewire, and an introducer sheath having a lumen extending therethrough configured to receive the dilator, the method further comprising removing the dilator prior to advancing the lead through the introducer assembly.

29. A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:

selecting a guide needle having a longitudinal axis and a distal tip;

selecting a lead having a distal region including one or more electrodes;

locating a target vertebrae of the lumbar spine;

inserting the distal tip of the guide needle percutaneously at a first insertion site a lateral distance from a midline of the target vertebrae to a depth;

locating a second insertion site along the midline of the target vertebrae based on the depth; and

implanting the lead at the second insertion site with the distal region angled relative to the longitudinal axis of the guide needle, so that the lead traverses naturally occurring fascicle planes and the one or more electrodes are disposed in or adjacent to a tissue associated with control of the lumbar spine,

wherein implanting the lead at the second insertion site comprises;

selecting a delivery needle having a distal tip, a lumen and a longitudinal axis;

inserting the distal tip of the delivery needle percutaneously at the second insertion site such that the longitudinal axis of the delivery needle is angled approximately 45 degrees relative to the longitudinal axis of the guide needle;

advancing a guidewire through the lumen of the delivery needle;

removing the delivery needle;

advancing an introducer assembly over the guidewire;

removing the guidewire;

advancing the lead through the introducer assembly so that the one or more electrodes are disposed in or adjacent to the tissue associated with control of the lumbar spine; and

retracting the introducer assembly.

30. A method for implanting a device for restoring muscle function to a lumbar spine, the method comprising:

selecting a guide needle having a longitudinal axis and a distal tip;

selecting a lead having a distal region including one or more electrodes;

locating a target vertebrae of the lumbar spine;

inserting the distal tip of the guide needle percutaneously at a first insertion site a lateral distance from a midline of the target vertebrae to a depth;

locating a second insertion site along the midline of the target vertebrae based on the depth; and

implanting the lead at the second insertion site with the distal region angled relative to the longitudinal axis of the guide needle, so that the lead traverses naturally occurring fascicle planes and the one or more electrodes are disposed in or adjacent to a tissue associated with control of the lumbar spine,

wherein implanting the lead at the second insertion site comprises;

selecting a delivery needle having a distal tip, a lumen and a longitudinal axis;

inserting the distal tip of the delivery needle percutaneously at the second insertion site such that the longitudinal axis of the delivery needle is angled relative to the longitudinal axis of the guide needle, and advancing the distal tip of the delivery needle approximately 3-5 mm beyond the distal tip of the guide needle, thereby penetrating an intertransversarii;

advancing a guidewire through the lumen of the delivery needle;

removing the delivery needle;

advancing an introducer assembly over the guidewire;

removing the guidewire;

advancing the lead through the introducer assembly so that the one or more electrodes are disposed in or adjacent to the tissue associated with control of the lumbar spine; and

retracting the introducer assembly.