Systems and methods for restoring muscle function to the lumbar spine and kits for implanting the same

• US 9,950,159 B2
• Filed: 07/05/2016
• Issued: 04/24/2018
• Est. Priority Date: 10/23/2013
• Status: Active Grant

• Current Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Original Assignee: Mainstay Medical Limited (Mainstay Medical International Ltd.)
• Inventors: Beck, John, Skubitz, Jason, Crosby, Peter, DeMorett, Henry, Shiroff, Jason Alan
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US15/202,435
• Publication Number:
  US 20160310732A1
• Time in Patent Office: 658 Days
• Field of Search: 606170, 607 72, 607117
• 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 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 2/008 for pain treatment or analgesia
• CPC Class Codes: A61N 2/06 using magnetic fields produced by permanent magnets A61N2/12 takes precedence

Abstract

A system for restoring muscle function to the lumbar spine to treat low back pain is provided. The system may include one or more electrode leads coupled to an implantable pulse generator (IPG) and a tunneler system for subcutaneously implanting a proximal portion of the lead(s). The system may also include a handheld activator configured to transfer a stimulation command to the IPG, and an external programmer configured to transfer programming data to the IPG. The stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data. The system may include a software-based programming system run on a computer such that the treating physician may program and adjust stimulation parameters.

Claims

1. A kit for use in restoring muscle function of the lumbar spine, the kit comprising:

an electrode lead configured to be implanted in or adjacent to a tissue associated with control of the lumbar spine, the electrode lead having a proximal end and a distal end with one or more electrodes disposed thereon;

a first fixation element coupled to the electrode lead proximal to at least one of the one or more electrodes, the first fixation element configured to anchor the electrode lead to a first anchor site;

a second fixation element coupled to the electrode lead distal to the first fixation element, wherein the first fixation element is angled distally relative to the electrode lead and the second fixation element is angled proximally relative to the electrode lead in a deployed state, and wherein the first and second fixation elements are configured to sandwich the first anchor site therebetween;

a third fixation element coupled to the electrode lead distal to the first and second fixation elements, the third fixation element configured to anchor the electrode lead to a second anchor site;

a fourth fixation element coupled to the electrode lead distal to the first and second fixation elements and proximal to the third fixation element, wherein the third fixation element is angled proximally relative to the electrode lead and the fourth fixation element is angled distally relative to the electrode lead in a deployed state, and wherein the third and fourth fixation elements are configured to sandwich the second anchor site therebetween;

an implantable pulse generator configured to be coupled to the proximal end of the electrode lead, the implantable pulse generator having a programmable controller configured to provide electrical stimulation via the one or more electrodes disposed on the electrode lead;

a tunneler comprising an elongated shaft, a threaded distal portion, a proximal end having a handle, and a stopper positioned between the elongated shaft and the handle;

a sheath having a lumen extending therethrough configured to receive a portion of the tunneler and the proximal end of the electrode lead, the sheath sized and shaped to fit between the stopper and the threaded distal portion of the tunneler, the sheath further configured to be disposed temporarily in a subcutaneous passage; and

a tunneler tip having a mating portion configured to be coupled to the threaded distal portion of the tunneler, the tunneler tip configured to create the subcutaneous passage to accept the sheath.

2. The kit of claim 1, wherein the implantable pulse generator further comprises a first communications circuit, the kit further comprising:

a handheld activator having a second communications circuit, the activator configured to transfer a stimulation command to the implantable pulse generator via the first and second communications circuits; and

an external programmer having a third communications circuit, the external programmer configured to transfer programming data to the implantable pulse generator via the first and third communications circuits,

wherein the stimulation command directs the programmable controller to provide electrical stimulation in accordance with the programming data.

3. The kit of claim 1, wherein the electrode lead is configured to be implanted in or adjacent to at least one of a nervous tissue, a muscle, a ligament, and a joint capsule.

4. The kit of claim 1, wherein the programmable controller directs at least one of the one or more electrodes to stimulate a dorsal ramus nerve, or fascicles thereof, that innervate a multifidus muscle or nervous tissue associated with a dorsal root ganglia nerve or both.

5. The kit of claim 4, wherein the programmable controller directs the at least one of the one or more electrodes to stimulate both the dorsal ramus nerve, or fascicles thereof, that innervate the multifidus muscle, and the nervous tissue associated with the dorsal root ganglia nerve simultaneously.

6. The kit of claim 4, wherein the programmable controller directs the at least one of the one or more electrodes to stimulate the dorsal ramus nerve, or fascicles thereof, at stimulation parameters different than that of the stimulation of the nervous tissue associated with the dorsal root ganglia nerve.

7. The kit of claim 1, wherein the tunneler tip is selected from group comprising a bullet-shaped tunneler tip and a facet-shaped tunneler tip.

8. The kit of claim 1, wherein the electrode lead comprises a strain relief portion.

9. An electrode lead configured to be implanted in or adjacent to a tissue associated with control of the lumbar spine, the electrode lead comprising:

one or more electrodes disposed on the electrode lead;

a first fixation element coupled to the electrode lead proximal to at least one of the one or more electrodes, the first fixation element configured to anchor the electrode lead to a first anchor site;

a second fixation element coupled to the electrode lead distal to the first fixation element, wherein the first fixation element is angled distally relative to the electrode lead and the second fixation element is angled proximally relative to the electrode lead in a deployed state, and wherein the first and second fixation elements are configured to sandwich the first anchor site therebetween;

a third fixation element coupled to the electrode lead distal to the first and second fixation elements, the third fixation element configured to anchor the electrode lead to a second anchor site; and

a fourth fixation element coupled to the electrode lead distal to the first and second fixation elements and proximal to the third fixation element, wherein the third fixation element is angled proximally relative to the electrode lead and the fourth fixation element is angled distally relative to the electrode lead in a deployed state, and wherein the third and fourth fixation elements are configured to sandwich the second anchor site therebetween.

10. The electrode lead of claim 9, wherein the one or more electrodes are configured to stimulate a dorsal ramus nerve, or fascicles thereof, that innervate a multifidus muscle or nervous tissue associated with a dorsal root ganglia nerve or both.

11. The electrode lead of claim 9, wherein the electrode lead is configured to be implanted in or adjacent to at least one of a nervous tissue, a muscle, a ligament, and a joint capsule.

12. The electrode lead of claim 9, wherein the second fixation element is radially offset relative to the first fixation element such that the first and the second fixation elements do not overlap when collapsed inward toward the electrode lead in a delivery state.

13. A method for restoring muscle function of the lumbar spine to reduce back pain, the method comprising:

selecting an electrode lead having a proximal end and a distal end having one or more electrodes disposed thereon, the electrode lead comprising first and second oppositely-angled fixation elements configured to sandwich a first anchor site therebetween, and third and fourth oppositely-angled fixation elements distal to the first and second fixation elements configured to sandwich a second anchor site therebetween;

selecting an implantable pulse generator configured to be coupled to the proximal end of the electrode lead;

implanting the distal end of the electrode lead at a first incision site so that the one or more electrodes are disposed in or adjacent to tissue associated with control of the lumbar spine;

coupling the proximal end of the electrode lead to the implantable pulse generator; and

implanting the implantable pulse generator at a second incision site.

14. The method of claim 13, further comprising stimulating, via the one or more electrodes, a dorsal ramus nerve, or fascicles thereof, that innervate a multifidus muscle or nervous tissue associated with a dorsal root ganglia nerve or both.

15. A method for restoring muscle function of the lumbar spine to reduce back pain, the method comprising:

selecting an electrode lead having a proximal end and a distal end having one or more electrodes disposed thereon, the electrode lead comprising first and second oppositely-angled fixation elements configured to sandwich a first anchor site therebetween, and third and fourth oppositely-angled fixation elements distal to the first and second fixation elements configured to sandwich a second anchor site therebetween;

selecting an implantable pulse generator configured to be coupled to the proximal end of the electrode lead;

implanting the distal end of the electrode lead at a first incision site so that the one or more electrodes are disposed in or adjacent to tissue associated with control of the lumbar spine;

selecting a tunneler comprising an elongated shaft, a proximal end having a handle, and a distal portion removably coupled to a tunneler tip;

selecting a sheath having a lumen extending therethrough configured to receive the elongated shaft of the tunneler;

tunneling the tunneler, the sheath, and the tunneler tip subcutaneously between the first incision site and a second incision site such that the sheath spans the first and second incision sites, the sheath having the tunneler disposed therein during the tunneling;

decoupling the tunneler tip from the distal portion of the tunneler;

removing the tunneler from the sheath while the sheath continues to span the first and second incision sites;

feeding the proximal end of the electrode lead through an end of the sheath until the proximal end of the electrode lead is exposed at the other end of the sheath;

removing the sheath from the subcutaneous tunnel between the first and second incision sites;

coupling the proximal end of the electrode lead to the implantable pulse generator; and

implanting the implantable pulse generator at the second incision site.

16. The method of claim 15, wherein the one or more electrodes are disposed in or adjacent to at least one of a nervous tissue, a muscle, a ligament, and a joint capsule.

17. The method of claim 15, wherein the tunneler tip is selected from group comprising a bullet-shaped tunneler tip and a facet-shaped tunneler tip.

18. The method of claim 15, further comprising:

selecting an external programmer and a handheld activator;

transferring programming data to the implantable pulse generator from the external programmer; and

operating the handheld activator to command the implantable pulse generator to provide electrical stimulation to stimulate the tissue via the one or more electrodes responsive to the programming data.

19. The method of claim 18, wherein the handheld activator commands the implantable pulse generator to stimulate a dorsal ramus nerve, or fascicles thereof, that innervate a multifidus muscle, and/or a nervous tissue associated with a dorsal root ganglia nerve via at least one of the one or more electrodes.

20. The method of claim 18, wherein the handheld activator commands the implantable pulse generator to stimulate both the dorsal ramus nerve, or fascicles thereof, that innervate the multifidus muscle, and the nervous tissue associated with the dorsal root ganglia nerve via at least one of the one or more electrodes simultaneously.