Implantable neurostimulation lead for head pain

• US 9,839,777 B2
• Filed: 07/28/2016
• Issued: 12/12/2017
• Est. Priority Date: 08/14/2013
• Status: Active Grant

• Current Assignee: Shiratronics, Inc.
• Original Assignee: Syntilla Medical LLC
• Inventors: Reed, Kenneth Lyle, Bulger, Robert Raymond, Colvin, Michael Steven, Denault, Claire
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/222,821
• Publication Number:
  US 20160331953A1
• Time in Patent Office: 502 Days
• Field of Search: None
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/36075 Headache or migraine

Abstract

An implantable peripheral neurostimulation lead for head pain is adapted for implantation in the head for the therapeutic purpose of treating chronic head and/or face pain. The lead may include a lead body, a plurality of internal electrically conducting metal wires individually connecting to a proximal surface contact and a distal surface electrode; a distal extended metal surface electrode array; and a proximal in-line connector. The lead may be operable to provide medically acceptable therapeutic neurostimulation to multiple regions of the head, including the frontal, parietal, and occipital regions of the head simultaneously. The lead may include a supraorbital electrode array with electrodes of 3 to 5 mm in length spaced apart at 4 to 6 mm intervals. The lead may also include a temporal electrode array with electrodes of 4 to 6 mm in length spaced apart at 8 to 12 mm intervals.

Claims

1. An implantable neurostimulation lead comprising:

a lead body having a length with a proximal end and a distal end, the lead body further comprising contiguous portions including a proximal lead body portion, a central lead body portion and a distal lead body portion,

wherein the distal lead body portion comprises;

a cross section that tapers along at least a portion of the length thereof toward a distal end thereof,

wherein the diameter of the distal lead body portion decreases from a point adjacent the central lead body portion outward therefrom to the distal end of the distal lead body portion, and

a terminal lead body on the distal end of the distal lead body portion;

a plurality of electrode arrays spaced linearly on an exterior surface of the distal lead body portion, and not on the exterior surface of the central lead body portion, the plurality of electrode arrays including;

a distal supraorbital electrode array positioned on the terminal lead body proximate to the distal end including at least six supraorbital electrodes each having a length of 3 to 5 mm, the supraorbital electrodes uniformly spaced apart at 4 to 6 mm intervals with the distal most supraorbital electrode positioned 2 to 4 mm from a distal end of the terminal lead body; and

a medial temporal electrode array positioned on the distal lead body portion between the central lead body portion and the terminal lead body and including at least 4 temporal electrodes each having a length of 4 to 6 mm, the temporal electrodes uniformly spaced from 8 to 12 mm apart with the most distal temporal electrode spaced 16 to 24 mm from the most proximate supraorbital electrode; and

a plurality of internal conductive wires in the lead body wherein each wire of the plurality of internal conductive wires is connected to a different electrode of the plurality of electrode arrays and extends to the proximal end of the lead body.

2. The implantable neurostimulation lead of claim 1, wherein the proximal lead body portion and the central lead body portion comprise a rounded exterior surface along their length.

3. The implantable neurostimulation lead of claim 1, further comprising a proximal connector at the proximal end of the lead body, the proximal connector comprising a plurality of metal contacts such that each one of the metal contacts is electrically connected to a different wire of the plurality of internal conductive wires.

4. The implantable neurostimulation lead of claim 1, wherein the distal supraorbital electrode array positioned on the terminal lead body proximate to the distal end includes six supraorbital electrodes each having a length of 4 mm, the supraorbital electrodes uniformly spaced apart at 5 mm intervals with the distal most supraorbital electrode positioned 3 mm from the distal end of the terminal lead body.

5. The implantable neurostimulation lead of claim 1, wherein the temporal electrode array includes 4 temporal electrodes each having each having a length of 5 mm, the temporal electrodes uniformly spaced apart at 10 mm intervals with the most distal temporal electrode spaced 21 mm from the most proximate supraorbital electrode.

6. The neurostimulation lead of claim 1, wherein the distal portion of the lead body tapers toward the distal end.

7. The neurostimulation lead of claim 1, wherein a portion of the distal portion of the lead body is flat and at least a portion of a proximal portion of the lead body is rounded in cross section.

8. A head implantable neurostimulation lead, comprising:

a group of conductive internal wires;

a lead body having a length with a proximal end and a distal end;

the lead body contains the group of conductive internal wires;

the lead body comprises contiguous portions including a proximal lead body portion, a central lead body portion and a distal lead body portion;

wherein the distal lead body portion comprises;

a cross section that tapers along at least a portion of the length thereof toward a distal end thereof,

wherein the diameter of the distal lead body portion decreases from a point adjacent the central lead body portion outward therefrom to the distal end of the distal lead body portion, and

a terminal lead body on the distal end of the distal lead body portion;

the distal lead body portion includes a plurality of electrode arrays spaced from each other along a length of the distal lead body portion such that no electrode arrays or any portion thereof are disposed on the central lead body portion, wherein the plurality of electrode arrays comprises;

a distal supraorbital electrode array positioned on the terminal lead body proximate to the distal end including at least six supraorbital surface electrodes each having a length of 3 to 5 mm, the supraorbital surface electrodes uniformly spaced apart at 4 to 6 mm intervals with the distal most supraorbital surface electrode positioned 2 to 4 mm from a distal end of the terminal lead body; and

a medial temporal electrode array positioned on the distal lead body portion between the central lead body portion and the terminal lead body and including at least 4 temporal surface electrodes each having a length of 4 to 6 mm, the temporal surface electrodes uniformly spaced from 8 to 12 mm apart with the most distal temporal surface electrode spaced 16 to 24 mm from the most proximate supraorbital surface electrode; and

wherein each wire of the group of conductive internal wires is connected to a different electrode of the plurality of electrode arrays and extends to the proximal end of the lead body.

9. The head implantable neurostimulation lead of claim 8, further comprising a proximal connector at the proximal end of the lead body, the proximal connector comprising a plurality of metal contacts such that each one of the metal contacts is electrically connected to a different wire of the group of conductive internal wires.

10. The head implantable neurostimulation lead of claim 8, wherein the distal lead body portion comprises a cross section that tapers toward the distal end.

11. The head implantable neurostimulation lead of claim 8, wherein the distal lead body portion comprises a cross section that is thinner than a cross section of the central lead body portion.

12. The head implantable neurostimulation lead of claim 8, wherein the proximal lead body portion and the central lead body portion comprise a rounded exterior surface along their length.

13. The head implantable neurostimulation lead of claim 8, wherein the distal lead body portion comprise a flat exterior surface on at least a portion of its length.

14. The head implantable neurostimulation lead of claim 8, wherein the distal lead body does not incorporate a central channel or stylet.

15. The head implantable neurostimulation lead of claim 8, wherein the distal supraorbital electrode array positioned on the terminal lead body proximate to the distal end includes six supraorbital surface electrodes each having a length of 4 mm, the supraorbital surface electrodes uniformly spaced apart at 5 mm intervals with the distal most supraorbital surface electrode positioned 3 mm from the distal end of the terminal lead body.

16. The implantable neurostimulation lead of claim 8, wherein the temporal electrode array includes 4 temporal surface electrodes each having each having a length of 5 mm, the temporal surface electrodes uniformly spaced apart at 10 mm intervals with the most distal temporal surface electrode spaced 20 mm from the most proximate supraorbital surface electrode.

17. An implantable neurostimulation lead comprising:

a lead body having a length with a proximal end and a distal end, the lead body further comprising contiguous portions including a proximal lead body portion, a central lead body portion and a distal lead body portion;

a plurality of electrode arrays spaced linearly on an exterior surface of the distal lead body portion, and not on the exterior surface of the central lead body portion, the plurality of electrode arrays including;

a distal supraorbital electrode array positioned on a terminal lead body proximate to the distal end including at least six supraorbital electrodes each having a length of 3 to 5 mm, the supraorbital electrodes uniformly spaced apart at 4 to 6 mm intervals with the distal most supraorbital electrode positioned 2 to 4 mm from the distal end of the terminal lead body; and

a medial temporal electrode array positioned on the distal lead body portion between the central lead body portion and the terminal lead body and including at least 4 temporal electrodes each having a length of 4 to 6 mm, the temporal electrodes uniformly spaced from 8 to 12 mm apart with the most distal temporal electrode spaced 16 to 24 mm from the most proximate supraorbital electrode; and

a plurality of internal conductive wires in the lead body wherein each wire of the plurality of internal conductive wires is connected to a different electrode of the plurality of electrode arrays and extends to the proximal end of the lead body.