Implantable neural interface device with a deformable carrier

• US 9,289,151 B2
• Filed: 02/17/2015
• Issued: 03/22/2016
• Est. Priority Date: 01/17/2012
• Status: Active Grant

• Current Assignee: Neuronexus Technologies Incorporated (NEL Group, Inc.)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Kipke, Daryl R., Hetke, Jamille Farraye, Vetter, Rio J., Seymour, John P.
• Primary Examiner(s): DIETRICH, JOSEPH M
• Application Number:
  US14/623,991
• Publication Number:
  US 20150164360A1
• Time in Patent Office: 399 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2562/187 Strain relief means
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6868 Brain
• 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 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

An improved deformable carrier or connector for an implantable neural interface device is described. The neural interface device comprises a carrier supporting at least one electrode array. The carrier comprises a tubular sidewall extending from a proximal carrier portion to a distal carrier portion. At least one deformable segment is provided in the carrier sidewall. The deformable segment is more pliable than the remainder of the carrier sidewall to preferably move in response to forces imparted on the carrier and the electrode array by the shifting forces in body tissue. The deformable segment takes the form of a thinned sidewall segment or a slitted wall segment.

Claims

1. A neural interface device, which comprises:

a) a carrier having a carrier sidewall of a first wall thickness extending along a longitudinal axis from a proximal carrier end of a proximal carrier portion to a distal carrier portion having a distal carrier end;

b) a substrate supported on the distal carrier portion;

c) at least one electrode supported on the substrate, wherein the electrode is configured for at least one of electrical stimulation of body tissue and sensing of physiological characteristics of the body tissue;

d) at least one electrical conductor that extends from the proximal carrier portion to the at least one electrode supported on the substrate, wherein the electrical conductor is electrically connectable to a medical device; and

e) at least one deformable segment of the proximal carrier portion intermediate the proximal carrier end and the substrate supported on the distal carrier portion, wherein the at least one deformable segment has a second wall thickness that is less than the first wall thickness of the carrier sidewall to thereby provide the deformable segment being relatively more pliable than the remainder of the proximal carrier portion not provided with the deformable segment,

f) wherein the at least one electrical conductor has at least one first coiled segment of a relatively higher coiling density and at least one second coiled segment of a relatively lower coiling density than the first coiled segment, and

g) wherein the at least one second coiled segment of the lower coiling density is substantially aligned with the at least one deformable segment of the second wall thickness and the at least one first coiled segment of the higher coiling density is aligned with a relatively less pliable section anywhere along the remainder of the proximal carrier portion not provided with the deformable segment.

2. The neural interface device of claim 1 wherein the carrier is of a polymeric material.

3. The neural interface device of claim 1 wherein the carrier has a tubular structure providing a lumen extending from the proximal carrier portion to the distal carrier end.

4. The neural interface device of claim 3 wherein the electrical conductor is wound around at least one of the group consisting of an external surface of the tubular carrier sidewall, within the carrier sidewall, and an internal surface of the tubular carrier sidewall.

5. The neural interface device of claim 1 wherein the deformable segment is a radiused curvature recessed into the first wall thickness of the carrier sidewall.

6. The neural interface device of claim 5 wherein the radiused curvature of the at least one deformable segment extends around an annular extent of the carrier sidewall.

7. The neural interface device of claim 5 wherein the radiused curvature of the at least one deformable segment has a cross-section along a plane aligned along the longitudinal axis of the carrier, wherein the radiused curvature meets the proximal carrier portion of the first wall thickness and curves to a trough having the second wall thickness at about a mid-point of the curvature and then back to the proximal carrier portion of the first wall thickness.

8. The neural interface device of claim 1 wherein the at least one deformable segment has a graduated thickness that is thinnest at a proximal end of the segment and thickens as the deformable segment extends distally.

9. The neural interface device of claim 8 wherein the graduated thickness of the deformable segment extends around an annular extent of the carrier sidewall.

10. The neural interface device of claim 1 wherein the at least one deformable segment has a graduated thickness that is thinnest at a distal end of the segment and thickens as the deformable segment extends proximally.

11. The neural interface device of claim 10 wherein the graduated thickness of the deformable segment extends around an annular extent of the carrier sidewall.

12. The neural interface device of claim 1 wherein there are at least two deformable segments at spaced locations along the carrier.

13. The neural interface device of claim 1 wherein the at least two deformable segments are from about 1 mm to about 5 mm from each other.

14. The neural interface device of claim 1 wherein the carrier sidewall has a substantially cylindrical inner surface.

15. The neural interface device of claim 1 wherein the substrate is of a polymeric material selected from the group consisting of parylene, polyimide, silicone, silicon nitride, silicon dioxide, silicon carbide, and mixtures thereof.

16. The neural interface device of claim 1 wherein the deformable segment is compressible, tensile, articulatable, and rotatable.

17. The neural interface device of claim 1 wherein the proximal carrier portion of the first wall thickness is of a first polymeric material having a durometer ranging from about 75 to about 60 and the deformable segment of the second wall thickness is of a second polymeric material having a durometer ranging from about 50 to about 30.

18. The neural interface device of claim 17 wherein the first and second polymeric materials are the same or different.

19. The neural interface device of claim 1 wherein the carrier is of silicone or polyurethane.

20. The neural interface device of claim 1 wherein the deformable segment has a length of from about 0.5 mm to about 2 mm.

21. The neural interface device of claim 1 wherein the substrate comprises perforations that permits the carrier to anchor therein.

22. A neural interface device, which comprises:

a) a carrier having a carrier sidewall of a first wall thickness extending along a longitudinal axis from a proximal carrier end of a proximal carrier portion to a distal carrier portion;

b) a substrate supported on the distal carrier portion;

c) at least one electrode supported on the substrate, wherein the electrode is configured for at least one of electrical stimulation of body tissue and sensing of physiological characteristics of the body tissue;

d) at least one electrical conductor that extends from the proximal carrier portion to the at least one electrode supported on the substrate, wherein the electrical conductor is electrically connectable to a medical device; and

e) at least one deformable segment of the carrier sidewall intermediate the proximal carrier end and the substrate supported on the distal carrier portion, wherein the at least one deformable segment has a second wall thickness that is less than the first wall thickness of the carrier sidewall to thereby provide the deformable segment being relatively more pliable than the remainder of the carrier sidewall not provided with the deformable segment,

f) wherein the at least one electrical conductor has at least one first coiled segment of a relatively higher coiling density and at least one second coiled segment of a relatively lower coiling density than the first coiled segment, and

g) wherein the at least one second coiled segment of the lower coiling density is substantially aligned with the at least one deformable segment of the second wall thickness and the at least one first coiled segment of the higher coiling density is aligned with a relatively less pliable section anywhere along the remainder of the proximal carrier portion not provided with the deformable segment.

23. The neural interface device of claim 22 wherein the proximal carrier portion of the first wall thickness is of a first polymeric material having a durometer ranging from about 75 to about 60 and the deformable segment of the second wall thickness is of a second polymeric material having a durometer ranging from about 50 to about 30.

24. A neural interface device, which comprises:

a) a carrier having a carrier sidewall of a first wall thickness extending along a longitudinal axis from a proximal carrier end of a proximal carrier portion to a distal carrier portion;

b) a substrate supported on the distal carrier portion;

c) at least two electrodes supported on the substrate, wherein each of the at least two electrodes is configured for at least one of electrical stimulation of body tissue and sensing of physiological characteristics of the body tissue;

d) at least a first electrical conductor and a second electrical conductor, wherein both electrical conductors extend from either the proximal carrier end or the proximal carrier portion to a respective one of the at least two electrodes; and

e) at least a first, second and third deformable segments of the proximal carrier portion intermediate the proximal carrier end and the substrate, wherein the first, second and third deformable segments each have respective second, third and fourth wall thicknesses that are less than the first wall thickness to thereby provide the deformable segments being relatively more pliable than the remainder of the proximal carrier portion not provided with the deformable segments, and wherein a first distance between the first and second deformable segments is less than a second distance between the second and third deformable segments extending in either a proximal or distal direction along the longitudinal axis from the first to the third segments, and

f) wherein the first and second electrical conductors each have at least one first coiled segment of a relatively higher coiling density and at least one second coiled segment of a relatively lower coiling density than the first coiled segment,

g) wherein the second coiled segment of the lower coiling density of the first electrical conductor is substantially aligned with one of the first, second and third deformable segments and the first coiled segment of the higher coiling density of the first electrical conductor is aligned with a relatively less pliable section anywhere along the remainder of the proximal carrier portion not provided with the first, second and third deformable segments of the respective second, third and fourth wall thicknesses, and

h) wherein the second coiled segment of the lower coiling density of the second electrical conductor is substantially aligned with one of the first, second and third deformable segments and the first coiled segment of the higher coiling density of the second electrical conductor is aligned with a relatively less pliable section anywhere along the remainder of the proximal carrier portion not provided with the first, second, and third deformable segments of the respective second, third and fourth wall thicknesses.