Medical device that applies electrical stimulation to the spinal cord from inside the dura for treating back pain and other conditions

Patent metadata

Field	Value
Publication number	US-11413449-B2
Application number	US-202016790329-A
Country	US
Kind code	B2
Filing date	Feb 13, 2020
Priority date	Nov 11, 2010
Publication date	Aug 16, 2022
Grant date	Aug 16, 2022

Abstract

This invention provides an device for electrical stimulation of the spinal cord. The device has an electrode assembly with a sufficiently thin profile to be implanted between the pial surface of the spinal cord and the dura mater, and secured to the dura. Electrodes on the electrode assembly are directed towards the surface of the spinal cord, and connected through the dura to a signal generator located outside the dura. Following implantation, the subject is treated by transmitting electrical signals from the signal generator through the leads to the electrodes, stimulating the subject's spinal cord.

First claim

The invention claimed is:

1. A method for stimulating a spinal cord that is prone to transmit deleterious nerve signals in a subject, the method comprising:
implanting an electrode assembly into the subject at a position between the pial surface of the spinal cord and the dura mater that surrounds the spinal cord,
wherein the electrode assembly is constructed with a sufficiently thin profile to be implanted at said position between the pial surface and the dura mater without obstructing flow of cerebrospinal fluid (CSF) around the spinal cord;
implanting a signal generator into the subject outside of the dura mater;
electrically connecting leads from the electrode assembly through the dura mater to the signal generator;
securing the electrode assembly to the dura mater so as to maintain the assembly at said position; and then
applying to the spinal cord by way of the electrode assembly an electrical stimulus that inhibits transmission of the deleterious nerve signals.

2. The method of claim 1 , wherein the implanting includes securing the electrode assembly to the dura mater of the spinal cord by a water-tight dura-traversing lead fitting.

3. The method of claim 1 , wherein the implanting includes securing the electrode assembly wherefrom electrodes in the electrode assembly are maintained in direct contact with a region of the spinal cord unaffected by movement of the subject.

4. The method of claim 1 , wherein the electrode assembly comprises at least 10 electrodes arrayed on a pliable backing.

5. The method of claim 1 , wherein the electrical stimulus alternates at a frequency between 2,000 and 20,000 Hz.

6. A method for inhibiting transmission of deleterious nerve signals through the spinal cord of a subject in need thereof,
wherein the subject has been implanted with a medical device that comprises:
(1) an electrode assembly, implanted in the spinal cord of the subject at a position between the pial surface and the dura mater of the spinal cord and secured to the dura mater, wherein the electrode assembly is configured and implanted at said position so as not to tether the spinal cord to the dura mater;
(2) a signal generator, implanted outside the dura mater; and
(3) leads that electrically connect the signal generator through the dura mater to the electrode assembly;
wherein the method comprises applying to the spinal cord by way of the electrode assembly an electrical stimulus, thereby inhibiting transmission of the deleterious nerve signals through the subject's spinal cord.

7. The method of claim 6 , wherein the electrode assembly has been secured to the dura mater of the subject's spinal cord by a water-tight dura-traversing lead fitting.

8. The method of claim 6 , wherein the electrical stimulus alternates at a frequency that causes stochastic depolarization of the spinal cord, thereby inhibiting transmission of synchronous action potentials initiated within the spinal cord.

9. The method of claim 6 , further comprising adjusting the frequency of the electrical stimulus that is being applied to the spinal cord of the subject.

10. The method of claim 6 , wherein the electrical stimulus alternates at a frequency at or above 500 Hz.

11. The method of claim 6 , wherein of the electrical stimulus alternates at a frequency between 2,000 and 20,000 Hz.

12. The method of claim 6 , wherein the electrical stimulus varies in a non-uniform pattern or at stochastic intervals.

13. A method of treating back pain in a subject, comprising inhibiting transmission of deleterious nerve signals through the spinal cord of the subject according to the method of claim 6 .

14. An assembly of components for a medical device that is configured for stimulating a subject's spinal cord, the assembly comprising:
an electrode assembly that is constructed and arranged to be secured to the dura mater of the spinal cord when implanted at a position between the pial surface and the dura matter of the spinal cord, wherein the electrode assembly has a sufficiently thin profile so that it will not obstruct flow of cerebrospinal fluid (CSF) around the spinal cord when thus implanted and secured:
a plurality of electrodes positioned on the electrode assembly that are directed towards the surface of the spinal cord when the electrode assembly is thus implanted and secured;
electrical leads passing from the plurality of electrodes of the electrode assembly that are electrically connectable through the dura mater to a signal generator located outside the dura mater when the electrode assembly is thus implanted and secured; and
said signal generator, implantable in the subject at a location outside the dura mater of the spinal cord wherefrom it is connectable by way of the electrical leads to the electrodes of the electrode assembly thus implanted and secured;
wherein the signal generator is configured to transmit electrical signals through the leads to the plurality of electrodes of the electrode assembly, and thereby to apply to the spinal cord of the subject an electrical stimulus to stimulate the subject's spinal cord.

15. An assembly of components according to claim 14 , wherein the electrical stimulus alternates at a frequency at or above 200 Hz.

16. An assembly of components according to claim 14 , wherein the electrical stimulus alternates at a frequency between 2,000 and 20,000 Hz.

17. An assembly of components according to claim 14 , wherein the frequency of the electrical stimulus that is applied to the spinal cord of the subject is adjustable.

18. An assembly of components according to claim 14 , wherein the electrode assembly comprises at least 10 electrodes arrayed on a pliable backing.

19. An assembly of components according to claim 14 , further comprising a lead fitting that is configured to secure the electrode assembly to the dura mater to form a water-tight closure, through which the electrical leads from the electrode array inside the dura mater are connectable to the signal generator outside the dura mater.

20. An assembly of components according to according to claim 14 , wherein the electrical stimulus is adjustable in response to pain experienced by the subject so as to further inhibit transmission through the spinal cord of synchronous action potentials.

Assignees

• Univ Iowa Res Found
• Univ Virginia Patent Foundation

Inventors

• Howard Matthew A
• Brennan Timothy
• Dalm Brian
• Utz Marcel
• Gillies George T
• Scott Steven
• Nelson Randall S
• Shurig Robert

Classifications

• A61N1/36171

  Frequency · CPC title

• A61N1/36071

  Pain · CPC title

• A61N1/0553 Primary

  Paddle shaped electrodes, e.g. for laminotomy · CPC title

• A61N1/0556

  Cuff electrodes · CPC title

• A61N1/0558

  Anchoring or fixation means therefor · CPC title