Spinal cord stimulation system

• US 9,757,557 B2
• Filed: 11/07/2013
• Issued: 09/12/2017
• Est. Priority Date: 07/28/2010
• Status: Expired due to Fees

• 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:
  US14/074,425
• Publication Number:
  US 20140066950A1
• Time in Patent Office: 1,405 Days
• 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 stimulation system for stimulating the spinal cord of the body of a subject, the stimulation system comprising:

a stimulating electrode array configured for insertion into the body of the subject proximate the spinal cord of the subject, the stimulating electrode array having a top surface and a bottom surface and comprising;

a plurality of electrodes;

a peripheral side edge extending between the top surface and the bottom surface, the peripheral side edge having a distal cutting portion shaped to form a bevel that is capable of cutting through tissue of the subject to thereby form an insertion pathway within the body of the subject, wherein at least the distal cutting portion of the peripheral side edge comprises a substantially rigid biodegradable material, the substantially rigid biodegradable material-configured to degrade such that the distal cutting portion degrades within the body of the subject at a predetermined rate; and

at least one engagement portion positioned along the peripheral side edge; and

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,

wherein, prior to degradation of the substantially rigid biodegradable material, the stimulating electrode array is sufficiently rigid to prevent undesired movement of the stimulating electrode array during insertion of the stimulating electrode array into the body of the subject, and wherein, following degradation of the substantially rigid biodegradable material, the stimulating electrode array is sufficiently flexible for placement in a desired position within the body of the subject, and

wherein the bevel of the distal cutting portion of the peripheral side edge degrades to avoid undesired injury to the subject after insertion of the stimulating electrode array into the body of the subject.

2. The stimulation system of claim 1, wherein, following engagement between the snare means of at least one steering member and the corresponding engagement portion of the stimulating electrode array, the snare means is configured for selective retraction such that the engagement portion is retained against the distal end of the housing.

3. The stimulation system of claim 1, 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 snare means of the first steering member is configured to engage the first engagement portion, and wherein the snare means of the second steering member is configured to engage the second engagement portion.

4. The stimulation system of claim 1, wherein the elongate housing of each steering member of the at least one steering member comprises a radio-lucent material.

5. The stimulation system of claim 1, wherein the elongate housing of each steering member of the at least one steering member comprises a radio-opaque material.

6. The stimulation system of claim 1, 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 retractable portion of the snare means is configured for advancement such that the engagement end of the retractable portion engages the corresponding engagement portion of the stimulating electrode array.

7. The stimulation system of claim 6, wherein each engagement portion of the stimulating electrode array comprises a guide loop, and wherein the retractable portion of the snare means of each steering member is configured for engagement such that the engagement end of the retractable portion is received by a corresponding guide loop of the stimulating electrode array.

8. The stimulation system of claim 1, 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, and wherein the snare means of each steering member is configured for selective deployment such that both the first loop and the second loop of the snare means receive the corresponding engagement portion of the stimulating electrode array.

9. The stimulation system of claim 8, wherein the snare means of each steering member is configured for selective retraction such that the first loop and the second loop are pulled in opposing directions relative to the longitudinal axis of the engagement portion.

10. The stimulation system of claim 1, further comprising a thumb guide ring mounted thereon the handle of at least one steering member and operatively coupled to the snare means of the at least one steering member.

11. The stimulation system of claim 10, wherein the thumb guide ring is operatively coupled to the snare means of the at least one steering member such that selective advancement and retraction of the thumb guide ring effects a corresponding movement of the snare means.

12. A stimulation system for stimulating the spinal cord of the body of a subject, the stimulation system comprising:

a stimulating electrode array configured for insertion into the body of the subject proximate the spinal cord of the subject, the stimulating electrode array having a top surface and a bottom surface and comprising;

a plurality of electrodes;

a peripheral side edge extending between the top surface and the bottom surface, the peripheral side edge having a distal beveled portion configured to cut through tissue of the subject to thereby form an insertion pathway within the body of the subject, wherein at least the distal beveled portion of the peripheral side edge comprises a substantially rigid biodegradable material, the substantially rigid biodegradable material configured to degrade such that the distal beveled portion degrades within the body of the subject at a predetermined rate; and

at least one engagement portion positioned along the peripheral side edge; and

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,

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 snare means of each steering member is configured for selective deployment such that both the first loop and the second loop of the snare means receive the corresponding engagement portion of the stimulating electrode array, and wherein the snare means of each steering member is configured for selective retraction such that the first loop and the second loop are pulled in opposing directions relative to the longitudinal axis of the engagement portion,

wherein, prior to degradation of the substantially rigid biodegradable material, the stimulating electrode array is sufficiently rigid to prevent undesired movement of the stimulating electrode array during insertion of the stimulating electrode array into the body of the subject, and wherein, following degradation of the substantially rigid biodegradable material, the stimulating electrode array is sufficiently flexible for placement in a desired position within the body of the subject, and

wherein the degradation of the distal beveled portion of the peripheral side edge avoids undesired injury to the subject after insertion of the stimulating electrode array into the body of the subject.

13. The stimulation system of claim 12, wherein, following engagement between the snare means of at least one steering member and the corresponding engagement portion of the stimulating electrode array, the snare means is configured for selective retraction such that the engagement portion is retained against the distal end of the housing.

14. The stimulation system of claim 12, 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 snare means of the first steering member is configured to engage the first engagement portion, and wherein the snare means of the second steering member is configured to engage the second engagement portion.

15. The stimulation system of claim 12, wherein the elongate housing of each steering member of the at least one steering member comprises a radio-lucent material.

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

17. The stimulation system of claim 12, further comprising a thumb guide ring mounted thereon the handle of at least one steering member and operatively coupled to the snare means of the at least one steering member.

18. The stimulation system of claim 17, wherein the thumb guide ring is operatively coupled to the snare means of the at least one steering member such that selective advancement and retraction of the thumb guide ring effects a corresponding movement of the snare means.