IMPLANTABLE NEUROSTIMULATION LEAD FOR HEAD PAIN

• US 20150051678A1
• Filed: 08/14/2014
• Published: 02/19/2015
• 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
• Granted Patent: US 9,427,566 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3787 from an external energy source

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 an extended lead body, a plurality of internal electrically conducting metal wires running along at least a portion of its length and individually connecting to a proximal surface contact and a distal surface electrode; a distal extended metal surface electrode array, subdivided into a plurality of sub-arrays; and a proximal in-line connector, which may include a proximal surface contact array adapted to couple with a separate implantable pulse generator. 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.

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;

a plurality of electrode arrays spaced linearly on an exterior surface of the distal lead body portion, each electrode array having a plurality of electrodes spaced linearly along the distal lead body portion, the linear spacing between the plurality of electrode arrays is larger than the linear spacing between the plurality of electrodes in each electrode arrays; 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 electrodes and extends to the proximal end of the lead body.

2. The implantable neurostimulation lead of claim 1, wherein the distal lead body portion comprises a cross section that tapers toward the distal end.

3. The implantable neurostimulation lead of claim 1, wherein the distal lead body portion comprises a distal cross section that is thinner than a central cross section of the central lead body portion.

4. The implantable neurostimulation lead of claim 1, wherein the plurality of electrode arrays comprises a distal electrode array proximate to the distal end and a proximal electrode array proximate to the central lead body.

5. The implantable neurostimulation lead of claim 4, wherein the distal electrode array comprises a flat exterior surface.

6. The implantable neurostimulation lead of claim 4, wherein the distal electrode array is configured to be implanted and positioned in a patient proximate the supraorbital nerves and the distal electrode array is configured to be implanted and positioned in the patient proximate to the occipital nerves.

7. The implantable neurostimulation lead of claim 6, wherein the plurality of electrode arrays further comprises a central electrode array linearly spaced from and between the distal electrode array and the proximal electrode array, the central electrode array is configured to be implanted and positioned in the patient proximate to the auriculotemporal nerve.

8. The implantable neurostimulation lead of claim 1, wherein the plurality of electrode arrays comprises a distal electrode array proximate to the distal end and a proximal electrode array proximate to the central lead body;

and wherein a distal electrode spacing between electrodes in the distal electrode array is different from the proximal electrode spacing between electrodes in the proximal electrode array.

9. The implantable neurostimulation lead of claim 8, wherein the plurality of electrode arrays further comprises a central electrode array between the distal electrode array and the proximate electrode array;

and wherein a central electrode spacing between electrodes in the central electrode array is different from the distal electrode spacing.

10. 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 wires.

11. A head implantable neurostimulation lead, comprising:

a group of conductive wires;

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

the lead body contains the group of conductive wires;

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

the distal lead body portion comprises a plurality of electrode arrays spaced from each other along a length of the distal lead body portion;

each electrode array of the plurality of electrode arrays comprises at least two surface electrodes spaced in close proximity to each other; and

each surface electrode is connected to a different wire of the group of conductive wires.

12. The head implantable neurostimulation lead of claim 11, wherein the plurality of electrode arrays comprises a distal electrode array proximate to the distal end and a proximal electrode array proximate to the central lead body portion.

13. The head implantable neurostimulation lead of claim 12, wherein the plurality of electrode arrays further comprises a central electrode array between the distal electrode array and the proximal electrode array.

14. The head implantable neurostimulation lead of claim 11, wherein the at least two surface electrodes of one of the plurality of electrode arrays are spaced is different linear distance from each other than the at least two electrodes of a second one of the plurality of arrays.

15. The head implantable neurostimulation lead of claim 11, wherein the plurality of electrode arrays are spaced along the length of the distal lead body portion such that when the head implantable neurostimulation lead is implanted in a patient, a first electrode array of the plurality of electrode arrays is adapted to be positioned proximate to a supraorbital cranial region of the patient and a second electrode array of the plurality of electrode arrays is adapted to be positioned proximate to the occipital cranial region of the patient.

16. The head implantable neurostimulation lead of claim 15, wherein a third electrode array of the plurality of electrode arrays is between the first and the second electrode arrays and adapted to be positioned proximate to the parietal cranial region of the patient.

17. The head implantable neurostimulation lead of claim 11, further comprising a connector at the proximal end connected to the group of conductive wires and adapted to connect to a pulse generator.

18. The head implantable neurostimulation lead of claim 11, wherein the distal lead body portion comprises a cross section that tapers toward the distal end.

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

20. The head implantable neurostimulation lead of claim 11, wherein the proximal lead body portion and the central lead body portion comprise a rounded exterior surface along their length.

21. The head implantable neurostimulation lead of claim 11, wherein the distal lead body portion comprise a flat exterior surface on at least a portion of its length.

22. The head implantable neurostimulation lead of claim 11, wherein the distal lead body does not incorporate a central channel or stylet.

23. An implantable peripheral neurostimulation lead configured for implantation in the head, the neurostimulation lead comprising:

a lead body having a length, a proximal end adapted for connection to an implantable pulse generator and a distal end;

a plurality of conductive wires internal to the lead body that extend from the proximal end at least a portion of the length; and

a plurality of electrode arrays spaced from each other on a distal portion of the lead body, each of the plurality of electrode arrays comprising a plurality of surface electrodes spaced from each other, and each of the plurality of surface electrodes being connected to a different one of the plurality of conductive wires.

24. The neurostimulation lead of claim 23, wherein the plurality of surface electrodes in a first electrode array of the plurality of electrode arrays have a first spacing distance and wherein the plurality of surface electrodes in a second electrode array of the plurality of electrode arrays have a second spacing distance, wherein the first spacing distance is different from the second spacing distance.

25. The neurostimulation lead of claim 23, wherein the distal portion of the lead body tapers toward the distal end.

26. The neurostimulation lead of claim 23, 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.