Systems and methods for making and using electrical stimulation leads with shaped mesh contact assemblies

• US 8,965,528 B2
• Filed: 11/14/2013
• Issued: 02/24/2015
• 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: Howard, Joshua Dale
• Primary Examiner(s): Lavert, Nicole F
• Application Number:
  US14/080,424
• Publication Number:
  US 20140155967A1
• Time in Patent Office: 467 Days
• Field of Search: 607/37, 607/116
• US Class Current: 607/116
• CPC Class Codes: A61B 2562/225 Connectors or couplings
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: H01R 2107/00 Four or more poles
• CPC Class Codes: H01R 2201/12 for medicine and surgery
• CPC Class Codes: H01R 24/58 Contacts spaced along longitudinal axis of engagement
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

An electrical stimulation lead includes a lead body with electrodes disposed along the distal end portion of the lead body and terminals disposed along the proximal end portion of the lead body. Conductors electrically couple the terminals to the electrodes. A contact assembly is disposed at one of the proximal end portion or the distal end portion of the lead body. The contact assembly is formed from a shaped mesh and includes annular grooves defined along an outer surface of the shaped mesh; and a stylet tube disposed in a contact assembly lumen. Each of the conductors extends along at least a portion of the shaped mesh within the contact assembly lumen and external to the stylet tube. For each of the annular grooves, one of the electrodes or one of the terminals is disposed in the annular groove.

Claims

1. An electrical stimulation lead, comprising:

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

a plurality of electrodes disposed along the distal end portion of the lead body;

a plurality of terminals disposed along the proximal end portion of the lead body;

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

a contact assembly formed from a shaped mesh, the contact assembly disposed at one of the proximal end portion or the distal end portion of the lead body, the shaped mesh having an outer surface and defining a contact assembly lumen, the shaped mesh comprising

a plurality of annular grooves defined along the outer surface of the shaped mesh, and

at least one conductor aperture defined in each of the plurality of annular grooves, the at least one conductor aperture extending between the outer surface and the contact assembly lumen,

wherein each of the plurality of conductors extends through the at least one conductor aperture and along at least a portion of the shaped mesh within the contact assembly lumen,

wherein for each annular groove of the plurality of annular grooves, one of the plurality of electrodes or one of the plurality of terminals is disposed in the annular groove.

2. The electrical stimulation lead of claim 1, further comprising a stylet tube disposed within the contact assembly lumen, wherein the stylet tube defines a stylet lumen, and wherein each of the plurality of conductors extends through the at least one conductor aperture and along at least a portion of the shaped mesh within the contact assembly lumen and external to the stylet tube.

3. The electrical stimulation lead of claim 1, further comprising a stiffening agent infused into the shaped mesh to form a matrix with the shaped mesh.

4. The electrical stimulation lead of claim 3, wherein the stiffening agent is an epoxy.

5. The electrical stimulation lead of claim 3, wherein the stiffening agent is disposed in the contact assembly lumen.

6. A method of forming an electrical stimulation lead, the method comprising:

providing a contact assembly formed from a shaped mesh, the contact assembly having a first end portion, a second end portion, a longitudinal length, and an outer surface, wherein the contact assembly comprises a plurality of annular grooves defined along the outer surface of the shaped mesh, the plurality of annular grooves comprising a first annular groove and a second annular groove, wherein a first conductor aperture is defined within the first annular groove, and wherein a second conductor aperture is defined within the second annular groove;

coupling a first end portion of an elongated first conductor to a first contact;

extending a second end portion of the first conductor through the first conductor aperture of the contact assembly;

disposing the first contact within the first annular groove;

extending the second end portion of the first conductor out of the first end portion of the contact assembly;

extending the second end portion of the first conductor into a first end portion of a lead body;

coupling the second end portion of the first conductor to a second contact disposed along a second end portion of the lead body; and

coupling the first end portion of the lead body to the first end portion of the contact assembly.

7. The method of claim 6, further comprising

coupling a first end portion of an elongated second conductor to a third contact;

extending a second end portion of the second conductor through the second conductor aperture of the contact assembly;

disposing the third contact within the second annular groove;

extending the second end portion of the second conductor out of the first end portion of the contact assembly;

extending the second end portion of the second conductor into a first end portion of a lead body; and

coupling the second end portion of the second conductor to a fourth contact disposed along the second end portion of the lead body.

8. The method of claim 6, wherein providing a contact assembly formed from a shaped mesh comprises providing a contact assembly formed from a shaped mesh that comprises polyethylene terephthalate.

9. The method of claim 6, wherein providing a contact assembly comprises providing a contact assembly that comprises a contact assembly lumen defined in the shaped mesh, the contact assembly lumen extending along the entire longitudinal length of the contact assembly, and wherein the first and second conductors extend along at least a portion of the contact assembly lumen.

10. The method of claim 9, wherein disposing the first contact within the first annular groove comprises compressing at least a portion of the shaped mesh to enable the first contact to slide along the contact assembly.

11. The method of claim 9, wherein disposing the first contact within the first annular groove comprises disposing a ring-shaped contact within the first annular groove.

12. The method of claim 9, wherein providing a contact assembly comprises providing a contact assembly that comprises a stylet tubing disposed in the contact assembly lumen, wherein the stylet tubing defines a stylet lumen configured and arranged for receiving a stylet, and wherein the first and second conductors extend along at least a portion of the contact assembly lumen external to the stylet tubing.

13. The method of claim 12, further comprising applying a stiffening agent to the contact assembly lumen after disposing the first contact within the first annular groove.

14. The method of claim 13, wherein applying a stiffening agent to the contact assembly lumen comprises infusing the stiffening agent into the shaped mesh to form a matrix with the shaped mesh.

15. The method of claim 13, wherein applying a stiffening agent to the contact assembly lumen applying an epoxy to the contact assembly lumen.

16. The method of claim 6, wherein coupling a first end portion of an elongated first conductor to a first contact comprises coupling the first end portion of the first conductor to an electrode.

17. The method of claim 6, wherein coupling a first end portion of an elongated first conductor to a first contact comprises coupling the first end portion of the first conductor to a terminal.

18. The method of claim 6, further comprising disposing a retention sleeve within a retention sleeve annular groove defined along the outer surface of the shaped mesh.

19. The method of claim 6, wherein coupling the first end portion of the lead body to the first end portion of the contact assembly comprises reflowing at least one of a material forming the contact assembly or a material forming the lead body to couple the first end portion of the lead body to the first end portion of the contact assembly.

20. A method of forming an electrical stimulation lead, the method comprising:

providing a contact assembly, the contact assembly having a first end portion, a second end portion, a longitudinal length, and an outer surface, wherein the contact assembly comprises a plurality of annular grooves defined along the outer surface of the contact assembly, the plurality of annular grooves comprising a first annular groove and a second annular groove, wherein a first conductor aperture is defined within the first annular groove, and wherein a second conductor aperture is defined within the second annular groove;

coupling a first end portion of an elongated first conductor to a first contact;

extending a second end portion of the first conductor through the first conductor aperture of the contact assembly;

disposing the first contact within the first annular groove;

extending the second end portion of the first conductor out of the first end portion of the contact assembly;

extending the second end portion of the first conductor into a first end portion of a lead body;

coupling the second end portion of the first conductor to a second contact disposed along a second end portion of the lead body; and

coupling the first end portion of the lead body to the first end portion of the contact assembly.