Spinal cord stimulation system and methods of using same

• US 8,588,936 B2
• Filed: 07/28/2011
• Issued: 11/19/2013
• 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
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US13/193,250
• Publication Number:
  US 20120029528A1
• Time in Patent Office: 845 Days
• Field of Search: 606/129, 606/130, 607/115, 607/116, 607/117, 600/373, 600/377
• US Class Current: 607/116
• 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:

removably coupling a frame element to a stimulating electrode array, the stimulating electrode array comprising a plurality of electrodes and having a top surface, a bottom surface, a peripheral side edge extending between the top surface and the bottom surface, and at least one engagement portion positioned along the peripheral side edge, the 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, wherein the frame element is selectively removably coupled to the stimulating electrode array by 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 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; 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 nitinol.

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

inserting a stimulating electrode array into the body of the subject proximate the dorsal column of the subject, the stimulating electrode array comprising a plurality of electrodes and having a top surface, a bottom surface, a peripheral side edge extending between the top surface and the bottom surface, and at least one engagement portion positioned along the peripheral side edge, the peripheral side edge having a distal beveled portion configured to cut through tissue of the subject to thereby form an insertion pathway, the distal beveled portion comprising a substantially rigid biodegradable material, the substantially rigid biodegradable material of the distal beveled portion 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, wherein the step of inserting the stimulating electrode array comprises forming an insertion pathway through the tissue of the subject using the distal beveled portion of the stimulating electrode array; 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,

wherein, prior to degradation of the substantially rigid biodegradable material of the distal beveled portion, the stimulating electrode array is sufficiently rigid to prevent undesired movement of the stimulating electrode array during insertion of the stimulating electrode array, and wherein, following degradation of the substantially rigid biodegradable material of the distal beveled portion, the stimulating electrode array is sufficiently flexible for placement in the desired position.

5. The method of claim 4, 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.

6. The method of claim 4, 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.

7. The method of claim 4, 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 of the at least one 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 first steering member of the at least one 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.

8. The method of claim 7, 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.

9. The method of claim 8, 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.

10. The method of claim 9, 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.

11. The method of claim 9, wherein the elongate housing of each steering member of the at least one steering member comprises a radio-lucent material.

12. The method of claim 9, wherein the elongate housing of each steering member of the at least one steering member comprises a radio-opaque material.

13. The method of claim 9, 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.

14. The method of claim 13, 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.

15. The method of claim 9, 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.

16. The method of claim 15, 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.

17. The method of claim 9, 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.

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

selectively engaging a stimulating electrode array with at least one steering member, the stimulating electrode array comprising one or more electrodes and having a top surface, a bottom surface, a peripheral side edge extending between the top surface and the bottom surface, and at least one engagement portion, the peripheral side edge having a distal beveled portion configured to cut through tissue of the subject to thereby form an insertion pathway, the 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 selected 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,

wherein the step of selectively engaging the stimulating electrode array comprises selectively deploying the snare means of a first steering member of the at least one steering member such that the snare means engages a first engagement portion of the stimulating electrode array;

selectively retracting the snare means such that the first 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, wherein the step of selectively moving the steering member comprises forming an insertion pathway through the tissue of the subject using the distal beveled portion of the stimulating electrode array; 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.