Distally reinforced lead and methods of making and using

• US 10,179,234 B2
• Filed: 11/27/2013
• Issued: 01/15/2019
• Est. Priority Date: 12/03/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Leven, Jacob B.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US14/091,863
• Publication Number:
  US 20140155969A1
• Time in Patent Office: 1,875 Days
• Field of Search: 607116, 607115, 607119, 604523-528
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

An electrical stimulation lead includes a lead body that defines a central lumen extending along the longitudinal length of the lead body. The stimulation lead includes electrodes disposed along the distal end of the lead body, terminals disposed along the proximal end of the lead body, and conductors. Each conductor electrically couples at least one of the electrodes to at least one of the terminals. The stimulation lead also includes a tubular reinforcing member disposed in the central lumen of the lead body within a portion of the distal end of the lead body or at least one reinforcing member disposed upon the distal end of the lead body proximal of the plurality of electrodes. The reinforcing member stiffens a portion of the distal end of the lead body.

Claims

1. An electrical stimulation lead, comprising:

a lead body having a distal end, a proximal end, and a longitudinal length, the lead body defining a central lumen extending along the longitudinal length of the lead body;

a plurality of electrodes disposed along the distal end of the lead body,

a plurality of terminals disposed along the proximal end of the lead body,

a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals;

a tubular reinforcing member disposed in the central lumen of the lead body entirely within the distal end of the lead body, the reinforcing member extending proximal of the plurality of electrodes and extending beneath no more than half of the electrodes, wherein the reinforcing member is configured and arranged to stiffen a portion of the distal end of the lead body in which the reinforcing member resides; and

a stylet configured and arranged for insertion within the central lumen and passing through the tubular reinforcing member, wherein the stylet comprises a curved distal end that is configured and arranged, when inserted into the lead, to cause at least a portion of the distal end of the lead body, distal to the tubular reinforcing member, to curve, wherein the stylet is further configured and arranged so that the curved distal end is temporarily straightened when the stylet is retracted so that the curved distal end resides within the tubular reinforcing member.

2. The electrical stimulation lead of claim 1, wherein the reinforcing member is entirely disposed proximal of the plurality of electrodes.

3. The electrical stimulation lead of claim 1, wherein the reinforcing member extends beneath at least one of the plurality of electrodes.

4. The electrical stimulation lead of claim 1, wherein the reinforcing member comprises a hypotube.

5. The electrical stimulation lead of claim 4, wherein the hypotube is spiral cut along a length of the hypotube.

6. The electrical stimulation lead of claim 5, wherein the spiral cut varies in pitch along the length of the hypotube.

7. The electrical stimulation lead of claim 1, wherein the reinforcing member is a coiled wire.

8. An electrical stimulation system, comprising

the electrical stimulation lead of claim 1;

and

a control module coupleable to the electrical stimulation lead.

9. The electrical stimulation system of claim 8, further comprising a lead extension coupleable to the electrical stimulation lead and the control module.

15. A method of implanting an electrical stimulation lead, the method comprising:

providing the electrical stimulation lead of claim 1;

inserting the stylet into the central lumen of the lead body and through the tubular reinforcing member; and

implanting the electrical stimulation lead into a patient using the curved distal end of the stylet to curve at least a portion of the distal end of the lead body and steer the lead to a desired implantation site.

16. The method of claim 15, further comprising retracting the curved distal end of the stylet into the tubular reinforcing member to temporarily straighten the curved distal end of the stylet.

10. An electrical stimulation lead comprising:

a lead body having a distal end, a proximal end, an exterior, and a longitudinal length;

a plurality of electrodes disposed along the distal end of the lead body,

a plurality of terminals disposed along the proximal end of the lead body,

a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals; and

at least one reinforcing member disposed upon the exterior of the distal end of the lead body proximal of the plurality of electrodes, wherein the at least one reinforcing member is configured and arranged to stiffen a portion of the distal end upon which the at least one reinforcing member is disposed, wherein the at least one reinforcing member comprises a reinforcing tube having a length greater than a length of any one of the plurality of electrodes.

11. The electrical stimulation lead of claim 10, wherein the reinforcing member has a length greater than a combined length of at least four of the plurality of electrodes.

12. The electrical stimulation lead of claim 10, wherein the at least one reinforcing member is formed of metal.

13. An electrical stimulation system, comprising

the electrical stimulation lead of claim 10;

and

a control module coupleable to the electrical stimulation lead.

14. An electrical stimulation lead comprising:

a lead body having a distal end, a proximal end, an exterior, and a longitudinal length;

a plurality of electrodes disposed along the distal end of the lead body,

a plurality of terminals disposed along the proximal end of the lead body,

a plurality of conductors, each conductor electrically coupling at least one of the electrodes to at least one of the terminals; and

at least one reinforcing member disposed upon the exterior of the distal end of the lead body proximal of the plurality of electrodes, wherein the at least one reinforcing member is configured and arranged to stiffen a portion of the distal end upon which the at least one reinforcing member is disposed, wherein the at least one reinforcing member comprises a plurality of reinforcing bands attached to the distal end of the lead body.