Electrode leads for use with implantable neuromuscular electrical stimulator

• US 10,195,419 B2
• Filed: 08/06/2014
• Issued: 02/05/2019
• 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: Shiroff, Jason Alan, Skubitz, Jason John, Rawat, Prashant Brijmohansingh
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/453,423
• Publication Number:
  US 20140350653A1
• Time in Patent Office: 1,644 Days
• Field of Search: 607116, 607117, 607119, 607122, 607126, 607128, 607132
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An apparatus for neuromuscular electrical stimulation is provided. The apparatus may be a stimulation lead having an elongated member made up of at least one conductor and an insulative sheath surrounding at least a portion of the conductor. A distal portion of the elongated member may include one or more electrodes and at least one fixation element to secure the one or more electrodes in or adjacent to a desired anatomical site for providing stimulation thereto. The stimulation lead has a strain relief portion on the proximal side of the one or more electrodes, configured to reduce axial forces on the distal region of the elongated member, and the effects thereof, to reduce the risk of, or even prevent, displacement of the one or more electrodes and to accommodate localized flexural motion. The apparatus also may include at least one fixation element sized and configured to be deployed between muscle layers to maintain the electrode position at the stimulation site.

Claims

1. A method of implanting a lead for neuromuscular electrical simulation, the method comprising:

implanting a distal region of the lead in or adjacent to tissue associated with control of the lumbar spine within a patient, the lead consisting of;

an elongated member having a proximal end, a distal region, a plurality of electrodes and an anchoring mechanism disposed on the distal region, and a plurality of electrical conductors extending between the plurality of electrodes and the proximal end;

a strain relief portion consisting of an insulated loop of the elongated member disposed proximal of and spaced apart from the plurality of electrodes, the strain relief portion configured to reduce transmission of axial and lateral loads applied to the distal region of the elongated member and the anchoring mechanism; and

a suture sleeve consisting of a first end section having a truncated conical shape, a second end section having a truncated conical shape, a middle section between the first and second end sections, a first groove between the first end section and the middle section, a second groove between the middle section and the second end section, and a sleeve lumen extending through the suture sleeve, the sleeve lumen sized to permit passage of the proximal end of the elongated member therethrough, each of the first and second grooves configured to accept a suture to secure the suture sleeve to tissue beneath the skin,

wherein the anchoring mechanism includes distal fixation elements angled proximally relative to the elongated member and proximal fixation elements angled distally relative to the elongated member such that the distal and proximal fixation elements are angled towards one another to secure the plurality of electrodes in or adjacent to tissue associated with control of the lumbar spine within a patient.

2. The method of claim 1, wherein a portion of the strain relief portion is elastic.

3. The method of claim 1, wherein the plurality of electrical conductors are a plurality of helical coil conductors.

4. The method of claim 1, wherein the distal and proximal fixation elements are deployable tines.

5. The method of claim 1, wherein a portion of the plurality of electrical conductors is coiled.

6. The method of claim 1, wherein implanting the distal region of the lead comprises implanting the plurality of electrodes in or adjacent to at least one of nervous tissue, a muscle, a ligament, or a joint capsule.

7. The method of claim 1, further comprising stimulating with at least one of the plurality of electrodes a dorsal ramus nerve that innervates a multifidus muscle.

8. The method of claim 1, wherein a portion of the plurality of electrical conductors is extendable.

9. The method of claim 1, wherein implanting the distal region of the lead further comprises moving the anchoring mechanism between a first insertion position and a second deployed position.

10. The method of claim 1, wherein implanting the distal region of the lead comprises deploying the anchoring mechanism between muscle layers.

11. The method of claim 1, further comprising securing the elongated member to a superficial fascia within the patient using the suture sleeve.

12. The method of claim 1, wherein implanting the distal region of the lead comprises implanting at least one of the plurality of electrodes in or adjacent to nervous tissue.

13. A method of implanting a lead for neuromuscular electrical simulation, the method comprising:

implanting a distal region of the lead in or adjacent to tissue associated with control of the lumbar spine within a patient, the lead consisting of;

an elongated member having a proximal end, a distal region, a plurality of electrodes and an anchoring mechanism disposed on the distal region, and a plurality of electrical conductors extending between the plurality of electrodes and the proximal end; and

a strain relief portion consisting of an insulated loop of the elongated member disposed proximal of and spaced apart from the plurality of electrodes, the strain relief portion configured to reduce transmission of axial and lateral loads applied to the distal region of the elongated member and the anchoring mechanism,

wherein the anchoring mechanism includes distal fixation elements angled proximally relative to the elongated member and proximal fixation elements angled distally relative to the elongated member such that the distal and proximal fixation elements are angled towards one another to secure the plurality of electrodes in or adjacent to tissue associated with control of the lumbar spine within a patient.

14. The method of claim 13, wherein a portion of the strain relief portion is elastic.

15. The method of claim 13, wherein the plurality of electrical conductors are a plurality of helical coil conductors.

16. The method of claim 13, wherein the distal and proximal fixation elements are deployable tines.

17. The method of claim 13, wherein a portion of the plurality of electrical conductors is coiled.

18. The method of claim 13, wherein implanting the distal region of the lead comprises implanting the plurality of electrodes in or adjacent to at least one of nervous tissue, a muscle, a ligament, or a joint capsule.

19. The method of claim 13, further comprising stimulating with at least one of the plurality of electrodes a dorsal ramus nerve that innervates a multifidus muscle.

20. The method of claim 13, wherein a portion of the plurality of electrical conductors is extendable.

21. The method of claim 13, wherein implanting the distal region of the lead further comprises moving the anchoring mechanism between a first insertion position and a second deployed position.

22. The method of claim 13, wherein implanting the distal region of the lead comprises deploying the anchoring mechanism between muscle layers.

23. The method of claim 13, wherein implanting the distal region of the lead comprises implanting at least one of the plurality of electrodes in or adjacent to nervous tissue.