SPINAL CORD STIMULATION SYSTEM AND METHODS OF USING SAME

• US 20120029528A1
• Filed: 07/28/2011
• Published: 02/02/2012
• Est. Priority Date: 07/28/2010
• Status: Active Grant

• Current Assignee: University of Utah Research Foundation (State of Utah)
• Original Assignee: University of Utah Research Foundation (State of Utah)
• Inventors: MacDonald, Joel D., Fisher, Kirk
• Granted Patent: US 8,588,936 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 2017/320056 Tunnelers
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A method for optimizing the stimulation of the dorsal column of the spinal cord is disclosed. The method includes providing a stimulating electrode array and a frame element. The frame element is configured to couple to the stimulating electrode array and guide the stimulating electrode array to a desired position proximate the dorsal column of the spinal cord of a subject.

Claims

1. A method for optimizing stimulation of the dorsal column of the spinal cord of the body of a subject, the method comprising:

providing a stimulating electrode array, the stimulating electrode array comprising a plurality of electrodes and having at least one engagement portion, the stimulating electrode array having a peripheral side edge;

providing a frame element configured to conform to at least a portion of the peripheral side edge of the stimulating electrode array, the frame element comprising a material that is more rigid than the stimulating electrode array;

selectively coupling the frame element thereto the at least one engagement portion of the stimulating electrode array;

inserting the coupled frame element and stimulating electrode array into the body of the subject at a desired position proximate the dorsal column of the subject; and

disengaging the frame element from the at least one engagement portion of the stimulating electrode array such that the stimulating electrode array remains in the desired position.

2. The method of claim 1, wherein the step of inserting the coupled frame element and stimulating electrode array into the body of the subject comprises selectively advancing a dissection tool configured to form an insertion pathway having a cross-sectional shape and size corresponding to a cross-sectional shape and size of the coupled frame element and stimulating electrode array.

3. The method of claim 1, wherein the frame element comprises a distal portion having a beveled edge, and wherein the step of inserting the coupled frame element and stimulating electrode array into the body of the subject comprises selectively advancing the frame element to form an insertion pathway.

4. The method of claim 1, wherein the frame element comprises nitinol.

5. A method for optimizing stimulation of the dorsal column of the spinal cord of the body of a subject, the method comprising:

providing a stimulating electrode array, the stimulating electrode array comprising a plurality of electrodes and having at least one engagement portion, the stimulating electrode array having a peripheral side edge, at least a portion of the peripheral side edge comprising a substantially rigid biodegradable material, the substantially rigid biodegradable material of the peripheral side edge configured to degrade within the body of the subject at a predetermined rate;

inserting the stimulating electrode array into the body of the subject proximate the dorsal column of the subject; and

selectively moving the stimulating electrode array such that the stimulating electrode array is guided to a desired position proximate the dorsal column of the spinal cord of the subject.

6. The method of claim 5, wherein the step of inserting the stimulating electrode array into the body of the subject comprises selectively advancing a dissection tool configured to form an insertion pathway having a cross-sectional shape and size corresponding to a cross-sectional shape and size of the stimulating electrode array.

7. The method of claim 5, wherein the side edge of the stimulating electrode array comprises a distal beveled portion, and wherein the step of inserting the stimulating electrode array into the body of the subject comprises selectively advancing the stimulating electrode array to form an insertion pathway.

8. The method of claim 5, wherein the frame element comprises a biodegradable polymer.

9. The method of claim 5, wherein the step of inserting the stimulating electrode array into the body of the subject comprises:

providing at least one steering member having a longitudinal axis, each steering member comprising;

an elongate housing having a distal end and an opening proximate the distal end;

a snare means positioned within the housing and selectively extendable and retractable relative to the opening of the housing along the longitudinal axis of the steering member, wherein the snare means is configured to engage a corresponding engagement portion of the stimulating electrode array; and

a handle comprising means for selectively deploying and retracting the snare means, the means for selectively deploying and retracting the snare means being configured for selective, one-handed activation by a user;

selectively deploying the snare means of a steering member such that the snare means engages a corresponding engagement portion of the stimulating electrode array; and

selectively retracting the snare means such that the engagement portion is retained against the distal end of the housing.

10. The method of claim 9, wherein the step of selectively moving the stimulating electrode array comprises selectively moving the steering member such that the stimulating electrode array is guided to the desired position.

11. The method of claim 10, further comprising the step of disengaging the snare means from the engagement portion of the stimulating electrode array such that the stimulating electrode array remains in the desired position.

12. The method of claim 11, wherein the at least one engagement portion of the stimulating electrode array comprises a first engagement portion and a second engagement portion, and wherein the at least one steering member comprises a first steering member and a second steering member, and wherein the step of selectively deploying the snare means of a steering member comprises deploying the snare means of the first steering member such that the snare means of the first steering member engages the first engagement portion and deploying the snare means of the second steering member such that the snare means of the second steering member engages the second engagement portion.

13. The method of claim 11, wherein the elongate housing of each steering member of the at least one steering member comprises a radio-lucent material.

14. The method of claim 11, wherein the elongate housing of each steering member of the at least one steering member comprises a radio-opaque material.

15. The method of claim 11, wherein the snare means of each steering member of the at least one steering member comprises an elongate member having a retractable portion with an engagement end, and wherein the step of the selectively deploying the snare means comprises advancing the retractable portion of the snare means such that the engagement end of the retractable portion engages an engagement portion of the stimulating electrode array.

16. The method of claim 15, wherein each engagement portion of the stimulating electrode array comprises a guide loop, and wherein the step of selectively deploying the snare means comprises advancing the retractable portion of the snare means such that the engagement end of the retractable portion is received by a corresponding guide loop of the stimulating electrode array.

17. The method of claim 11, wherein each engagement portion of the stimulating electrode array protrudes outwardly from the stimulating electrode array along a respective longitudinal axis, wherein the snare means of each steering member of the at least one steering member comprises a first loop and a second loop, wherein the step of selectively deploying the snare means of a steering member comprises selectively deploying the snare means such that both the first loop and the second loop of the snare means receive an engagement portion of the stimulating electrode array.

18. The method of claim 17, wherein the step of selectively retracting the snare means comprises retracting the snare means such that the first loop and the second loop are pulled in opposing directions relative to the longitudinal axis of the engagement portion.

19. The method of claim 11, wherein the steps of selectively deploying and retracting the snare means comprises selectively advancing and retracting a thumb guide ring mounted thereon the handle of a steering member of the at least one steering member and operatively coupled to the snare means.

20. A method for optimizing stimulation of the dorsal column of the spinal cord of a subject, the method comprising:

providing a stimulating electrode array, the stimulating electrode array comprising one or more electrodes and having at least one engagement portion;

providing at least one steering member having a longitudinal axis, each steering member comprising;

an elongate housing having a distal end and an opening proximate the distal end;

a snare means positioned within the housing and selectively extendable and retractable relative to the opening of the housing along the longitudinal axis of the steering member, wherein the snare means is configured to engage a corresponding engagement portion of the stimulating electrode array; and

a handle comprising means for selectively deploying and retracting the snare means, the means for selectively deploying and retracting the snare means being configured for selective, one-handed activation by a user;

selectively deploying the snare means of a steering member such that the snare means engages a corresponding engagement portion of the stimulating electrode array;

selectively retracting the snare means such that the engagement portion is retained against the distal end of the housing;

selectively moving the steering member such that the stimulating electrode array is guided to a desired position proximate the dorsal column of the spinal cord of the subject; and

disengaging the snare means from the corresponding engagement portion of the stimulating electrode array such that the stimulating electrode array remains in the desired position.