Method for implanting an implantable device in body tissue

• US 10,034,615 B2
• Filed: 02/17/2015
• Issued: 07/31/2018
• Est. Priority Date: 10/17/2007
• Status: Active Grant

• Current Assignee: Neuronexus Technologies Incorporated (NEL Group, Inc.)
• Original Assignee: Neuronexus Technologies Incorporated (NEL Group, Inc.)
• Inventors: Hetke, Jamille Farraye, Kipke, Daryl R., Vetter, Rio J.
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): Cardinal, Erin M
• Application Number:
  US14/623,747
• Publication Number:
  US 20150157854A1
• Time in Patent Office: 1,260 Days
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/046 in a matrix array
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4041 Evaluating nerves condition
• CPC Class Codes: A61B 5/6877 Nerve
• 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

Abstract

An implantable device for body tissue, including an electrical subsystem that flexes within and interfaces with body tissue and a carrier that operates in the following two modes: provides structural support for the electrical subsystem during implantation of the device in body tissue and allows flexing of the electrical subsystem after implantation of the device in body tissue. The implantable device is preferably designed to be implanted into the brain, spinal cord, peripheral nerve, muscle, or any other suitable anatomical location. The implantable device, however, may be alternatively used in any suitable environment and for any suitable reason.

Claims

1. A method for implanting and using a neural interface device, comprising the steps of:

a) providing the neural interface device, comprising;

i) a carrier extending along a first carrier length from a proximal carrier portion to a distal carrier portion having a distal carrier end, wherein the carrier is of a bioresorbable material that is absorbable into body tissue after implantation;

ii) a first electrical subsystem, comprising;

A) a plurality of electrode sites configured to interface with neural tissue; and

B) an electrode substrate having a tubular shape and supporting the plurality of electrode sites; and

iii) an electrical connector extending from each of the plurality of electrode sites to a proximal connector portion adjacent to the proximal carrier portion,

iv) wherein at least a portion of the electrode substrate is woven with the carrier so that the plurality of electrode sites extend circumferentially relative to the first carrier length of the carrier and have exposed surfaces facing outwardly from the electrode substrate opposite the carrier;

b) implanting the neural interface device comprising the carrier, the first electrical subsystem, and the electrical connector into body tissue; and

c) permitting the neural interface device to remain implanted for a sufficient amount of time so that the carrier is absorbed into the body tissue, thereby leaving at least one of the plurality of electrode sites facing outwardly toward the neural tissue from the supporting electrode substrate.

2. The method of claim 1, further comprising the step of:

a) providing a stylet;

b) supporting the neural interface device on the stylet; and

c) penetrating the body tissue with the stylet to thereby implant the neural interface device.

3. The method of claim 1, including providing the first electrical subsystem being flexible after absorption of the carrier into body tissue.

4. The method of claim 1, including selecting the bioresorbable material of the carrier from the group consisting of polyglycolide, polylactide, a magnesium alloy, and a corrodible iron alloy.

5. The method of claim 1, including providing the carrier having a tubular shape.

6. The method of claim 5, including providing the tubular carrier having a diameter of about one millimeter.

7. The method of claim 1, including providing the carrier having a woven structure that enables the at least the portion of the electrode substrate to be woven into the carrier.

8. The method of claim 1, including providing the first electrical subsystem having the plurality of electrode sites that are configured to electrically stimulate different portions of the neural tissue.

9. The method of claim 1, including providing the plurality of electrode sites supported by the electrode substrate so that the electrode sites extend both circumferentially and axially relative to the first carrier length.

10. The method of claim 1, including providing the plurality of electrode sites supported by the electrode substrate, and configuring the electrode sites to electrically record from different portions of the neural tissue.

11. The method of claim 1, including providing the electrode substrate being of a thin-film polymer selected from the group consisting of parylene and silicone.

12. The method of claim 1, including providing the electrode substrate having a series of perforations that extend axially in a discontinuous manner along a second electrode substrate length.

13. The method of claim 1, including providing the first electrical subsystem having an elongated, substantially planar shape.

14. The method of claim 1, including electrically connecting the proximal connector portion of the electrical connector to a second electrical subsystem that is configured to control at least one of the plurality of electrode sites.

15. The method of claim 1, including providing the electrical connector as a flexible ribbon cable.

16. The method of claim 1, including providing a lumen extending through the carrier from the proximal carrier portion to the distal carrier end.

17. The method of claim 16, including configuring the lumen to receive a stylet having a sharpened end adapted to extend outwardly from the distal carrier end.

18. The method of claim 1, including providing the electrode substrate comprising longitudinal and circumferential bridge strips, wherein at least two longitudinal bridge strips are connected by at least three circumferential bridge strips, thereby defining a series of discontinuous perforations in the electrode substrate of the first electrical subsystem.

19. The method of claim 1, including providing the carrier comprising an inner tubular sidewall disposed inside an outer tubular sidewall with the first electrical subsystem located between the inner and outer carrier sidewalls, but with the exposed surface of at least one of the plurality of electrode sites facing outwardly from the electrode substrate opposite the inner and outer carrier sidewalls.

20. The method of claim 1, including providing the bioresorbable material of the carrier being completely absorbable into body tissue within about one month after implantation of the neural electrode device.

21. The method of claim 1, including providing the bioresorbable material of the carrier being completely absorbable into body tissue within about one year after implantation of the neural electrode device.

22. A method for implanting and using a neural interface device, comprising the steps of:

a) providing the neural interface device, comprising;

i) a tubular-shaped carrier extending along a first carrier length from a proximal carrier portion to a distal carrier portion, wherein the carrier is of a bioresorbable material selected from the group consisting of polyglycolide, polylactide, a magnesium alloy, and a corrodible iron alloy and that is absorbable into body tissue after implantation;

ii) an electrical subsystem, comprising;

A) a plurality of electrode sites, at least one of which is configured to interface with neural tissue;

B) an electrode substrate supporting the plurality of electrode sites; and

C) wherein at least a portion of the electrode substrate supporting the plurality of electrode sites is woven with the carrier so that the electrode sites are both circumferentially and axially disposed relative to the first carrier length and wherein the plurality of electrode sites have respective exposed surfaces facing outwardly from the electrode substrate opposite the carrier; and

iii) an electrical connector extending from each of the plurality of electrode sites to a proximal connector portion adjacent to the proximal carrier portion;

b) implanting the neural interface device comprising the carrier, the first electrical subsystem, and the electrical connector into body tissue; and

c) permitting the neural interface device to remain implanted for a sufficient amount of time so that at least a portion of the carrier is absorbed into the body tissue, thereby leaving at least one of the plurality of electrode sites facing outwardly toward the neural tissue from the supporting electrode substrate.

23. The method of claim 22, wherein a lumen extends through the carrier along the first carrier length from the proximal carrier portion to a distal carrier end of the distal carrier portion.

24. A method for implanting and using a neural interface device, comprising the steps of:

a) providing the neural interface device comprising

i) a carrier, comprising;

A) a woven carrier sidewall extending along a first carrier length from a proximal carrier portion to a distal carrier portion having a distal carrier end, wherein the carrier sidewall is of a bioresorbable polymer that is absorbable into body tissue after implantation; and

B) a lumen extending through the carrier along the first carrier length from the proximal carrier portion to the distal carrier end;

ii) an electrical subsystem, comprising;

A) a plurality of electrode sites configured to interface with neural tissue;

B) an electrode substrate supporting the plurality of electrode sites,

C) wherein at least a portion of the electrode substrate supporting the plurality of electrode sites is interwoven with the carrier sidewall so that the plurality of electrode sites extend circumferentially and axially relative to the first carrier length of the carrier and have exposed electrode surfaces facing outwardly, away from the electrode substrate interwoven with the carrier; and

iii) an electrical connector extending from each of the plurality of electrode sites to a proximal connector portion adjacent to the proximal carrier portion; and

b) implanting the neural interface device comprising the carrier, the first electrical subsystem, and the electrical connector into body tissue; and

c) permitting the neural interface device to remain implanted for a sufficient amount of time so that at least a portion of the carrier is absorbed into the body tissue, thereby leaving at least one of the plurality of electrode sites facing outwardly, away from the supporting electrode substrate.