Braided lead with embedded fixation structures

• US 8,676,347 B2
• Filed: 06/29/2012
• Issued: 03/18/2014
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Finley, James, Swoyer, John
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/537,494
• Publication Number:
  US 20140005754A1
• Time in Patent Office: 627 Days
• Field of Search: 607/2, 607116-117, 607126-128
• US Class Current: 607/117
• 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 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D10B 2509/00 Medical; Hygiene

Abstract

A therapy delivery element including a plurality of fibers braided to form an elongated braided structure with a lumen. At least one reinforcing structure is woven into the fibers of the braided structure. A portion of at least one reinforcing structure extends from the braided structure to form a fixation structure. A conductor assembly including a plurality of conductors is located in the lumen. An electrode assembly is located at a distal end of the conductor assembly. The electrode assembly includes a plurality of electrodes that are electrically coupled to the conductors. A connector assembly is located at a proximal end of the conductor assembly. The connector assembly includes a plurality of electrical contacts that are electrically coupled to the conductors. At least one of the braided structure or the reinforcing structure is attached to at least one of the electrode assembly or the connector assembly.

Claims

1. A therapy delivery element configured for at least partial insertion in a living body, the therapy delivery element comprising:

a plurality of fibers braided to form an elongated braided structure having a lumen;

at least one reinforcing structure woven into the fibers of the braided structure;

at least one fixation structure integrally formed with and extending distally from the at least one reinforcing structure, the at least one fixation structure terminating at a free-floating distal end, wherein;

in a deployed position, the at least one fixation structure extends generally radially outwardly from a central axis of the braided structure so that the distal end of the at least one fixation structure is spaced from the braided structure; and

in a collapsed position, the at least one fixation structure extends generally longitudinally along the braided structure so that the distal end of the at least one fixation structure is disposed proximate the braided structure;

a conductor assembly comprising a plurality of conductors located in the lumen;

an electrode assembly located at a distal end of the conductor assembly, the electrode assembly comprising a plurality of electrodes electrically coupled to the conductors; and

a connector assembly located at a proximal end of the conductor assembly, the connector assembly comprising a plurality of electrical contacts electrically coupled to the conductors, wherein at least one of the braided structure or the reinforcing structure is attached to at least one of the electrode assembly or the connector assembly.

2. The therapy delivery element of claim 1, wherein the braided structure is attached to both the electrode assembly and the connector assembly.

3. The therapy delivery element of claim 1, wherein the reinforcing structure is attached to at least the connector assembly.

4. The therapy delivery element of claim 1, wherein the at least one reinforcing structure is axially oriented and extends along substantially an entire length of the braided structure.

5. The therapy delivery element of claim 1, comprising a tubular structure surrounding the braided structure.

6. The therapy delivery element of claim 1, comprising a thermoplastic material melted into engagement with the braided structure.

7. The therapy delivery element of claim 1, wherein the at least one reinforcing structure is bonded to the braided structure.

8. The therapy delivery element of claim 1, wherein the at least one fixation structure includes a distal portion of the at least one reinforcing structure, a proximal portion of the at least one reinforcing structure being woven into the fibers of the braided structure, and the distal portion of the at least one reinforcing structure being removed from the fibers of the braided structure.

9. The therapy delivery element of claim 1, comprising:

a plurality of reinforcing structures each including a proximal portion woven into the fibers of the braided structure; and

a plurality of fixation structures including a distal portion of each of the plurality of the reinforcing structures being removed from the braided structure.

10. The therapy delivery element of claim 9, wherein the braided structure includes at least one reinforcing structure located along an entire length of the braided structure.

11. The therapy delivery element of claim 1, wherein the fixation structure comprises a shape configured to fold against the therapy delivery element during removal of the therapy delivery element from the living body.

12. The therapy delivery element of claim 1, comprising a plurality of fixation structures radially spaced around the elongated braided structure.

13. The therapy delivery element of claim 1, comprising a plurality of fixation structures axially offset along the elongated braided structure.

14. The therapy delivery element of claim 1, wherein the braided structure is configured to increase tensile strength of the therapy delivery element by at least 15%.

15. The therapy delivery element of claim 1, wherein the at least one fixation structure includes a length of at least 0.050 inches.

16. A neurostimulation system comprising:

an implantable pulse generator; and

a therapy delivery element comprising;

a plurality of fibers braided to form an elongated braided structure with a lumen;

at least one reinforcing structure woven into the fibers of the braided structure;

at least one fixation structure integrally formed with and extending distally from the at least one reinforcing structure, the at least one fixation structure terminating at a free-floating distal end, wherein;

in a deployed position, the at least one fixation structure extends generally radially outwardly from a central axis of the braided structure so that the distal end of the at least one fixation structure is spaced from the braided structure; and

in a collapsed position, the at least one fixation structure extends generally longitudinally along the braided structure so that the distal end of the at least one fixation structure is disposed proximate the braided structure;

a conductor assembly comprising a plurality of conductors located in the lumen;

an electrode assembly located at a distal end of the conductor assembly, the electrode assembly comprising a plurality of electrodes that are electrically coupled to the conductors; and

a connector assembly located at a proximal end of the conductor assembly, the connector assembly comprising a plurality of electrical contacts that are electrically coupled to the conductors and are configured to electrically couple with the implantable pulse generator, wherein at least one of the braided structure or the reinforcing structure is attached to at least one of the electrode assembly or the connector assembly.

17. The neurostimulation system of claim 16, wherein the at least one fixation structure includes a distal portion of the at least one reinforcing structure, wherein the distal portion extends from the braided structure with at least a proximal portion of the at least one reinforcing structure being woven into the fibers of the braided structure.

18. The neurostimulation system of claim 16, wherein the at least one reinforcing structure is bonded to the braided structure.

19. A therapy delivery element configured for at least partial insertion in a living body, the therapy delivery element comprising:

a plurality of fibers braided together to form an elongated substantially tubular braided structure including a lumen;

at least one reinforcing structure attached to the braided structure, a distal portion of the at least one reinforcing structure forming at least one fixation structure, the at least one fixation structure being integrally formed with and extending distally from the at least one reinforcing structure, the at least one fixation structure terminating at a free-floating distal end, wherein;

in a deployed position, the at least one fixation structure extends generally radially outwardly from a central axis of the braided structure so that the distal end of the at least one fixation structure is spaced from the braided structure; and

in a collapsed position, the at least one fixation structure extends generally longitudinally along the braided structure so that the distal end of the at least one fixation structure is disposed proximate the braided structure;

a conductor assembly disposed within the lumen, the conductor assembly including at least one conductor; and

an electrode assembly located at a distal end of the conductor assembly, the electrode assembly including at least one electrode electrically coupled to the at least one conductor.

20. The therapy delivery element of claim 19, wherein at least a proximal portion of the at least one reinforcing structure is woven into the fibers of the braided structure.

21. The therapy delivery element of claim 19, wherein the at least one reinforcing structure is bonded to the braided structure.

22. The therapy delivery element of claim 19, comprising a plurality of fixation structures radially spaced around the braided structure.