Method of making a braided lead with imbedded fixation structures

• US 9,526,887 B2
• Filed: 01/23/2014
• Issued: 12/27/2016
• Est. Priority Date: 06/29/2012
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Nuvectra Corporation
• Inventors: Finley, James, Swoyer, John M.
• Primary Examiner(s): ARBES, CARL J
• Application Number:
  US14/161,756
• Publication Number:
  US 20150202430A1
• Time in Patent Office: 1,069 Days
• US Class Current: 1/1
• 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: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: B29C 70/24 oriented in at least three directions forming a three dimensional structure
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes
• CPC Class Codes: D10B 2509/00 Medical; Hygiene
• CPC Class Codes: Y10T 29/49169 Assembling electrical component directly to terminal or elongated conductor
• CPC Class Codes: Y10T 29/49801 Shaping fiber or fibered material

Abstract

In some examples, a method of making a therapy delivery element configured for at least partial insertion in a living body includes braiding a plurality of fibers to form an elongated braided structure with a lumen. At least one reinforcing structure is weaved into the fibers of the braided structure. A portion of the reinforcing structure is extended from the braided structure to form at least one fixation structure. At least one of the braided structure or the reinforcing structure can be attached to at least one of an electrode assembly or a connector assembly.

Claims

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

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

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

extending a portion of the reinforcing structure from the braided structure to form at least one fixation structure;

locating a conductor assembly comprising a plurality of conductors in the lumen of the braided structure;

electrically coupling electrodes on an electrode assembly with the conductors;

attaching the electrode assembly to a distal end of the conductor assembly;

electrically coupling electrical contacts on a connector assembly with the conductors;

attaching the connector assembly to a proximal end of the conductor assembly; and

attaching at least one of the braided structure or the reinforcing structure to at least one of the electrode assembly or the connector assembly.

2. The method of claim 1, comprising attaching both the electrode assembly and the connector assembly to the braided structure.

3. The method of claim 1, comprising attaching the reinforcing structure to at least the connector assembly.

4. The method of claim 1, comprising:

locating a tubular structure around the braided structure; and

bonding the tubular structure to the braided structure.

5. The method of claim 1, comprising removing a distal end of the at least one reinforcing structure from the braided structure to form the fixation structure.

6. The method of claim 1, comprising shaping the fixation structure to fold against the therapy delivery element during removal of the therapy delivery element from the living body.

7. The method of claim 1, wherein extending the portion of the reinforcing structure from the braided structure includes pulling the portion of the reinforcing structure out of the braided structure to form the at least one fixation structure.

8. The method of claim 1, wherein extending the portion of the reinforcing structure from the braided structure includes:

cutting the reinforcing structure at a first location to form a distal end of the portion of the reinforcing structure; and

pulling the portion of the reinforcing structure out of the braided structure to form the at least one fixation structure, wherein the distal end of the portion of the reinforcing structure forms a distal end of the at least one fixation structure.

9. The method of claim 1, wherein extending the portion of the reinforcing structure from the braided structure includes:

cutting the reinforcing structure at a first location to form a proximal portion of the reinforcing structure and a distal portion of the reinforcing structure; and

pulling at least one of the proximal portion and the distal portion of the reinforcing structure out of the braided structure to form the at least one fixation structure.

10. The method of claim 9, wherein pulling at least one of the proximal portion and the distal portion includes pulling the proximal portion of the reinforcing structure out of the braided structure to form the at least one fixation structure, wherein:

a distal end of the proximal portion of the reinforcing structure forms a free-floating distal end of the at least one fixation structure; and

at least some of the proximal portion of the reinforcing structure remains within the braided structure to secure the at least one fixation structure to the therapy delivery element.

11. The method of claim 1, wherein the at least one fixation structure is 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.

12. A method of making a therapy delivery element configured for at least partial insertion in a living body, the method comprising:

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

attaching at least one reinforcing structure to the braided structure; and

pulling a portion of the reinforcing structure from the braided structure to form at least one fixation structure, the at least one fixation structure integrally formed with and extending from the at least one reinforcing structure, the at least one fixation structure terminating at a free-floating 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 free-floating 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 free-floating end of the at least one fixation structure is disposed proximate the braided structure.

13. The method of claim 12, wherein:

a distal end of the portion of the reinforcing structure forms the free-floating end of the at least one fixation structure; and

at least some of the proximal portion of the reinforcing structure remains within the braided structure to secure the at least one fixation structure to the therapy delivery element.

14. The method of claim 12, comprising:

cutting the reinforcing structure at a first location to form a proximal portion of the reinforcing structure and a distal portion of the reinforcing structure; and

pulling at least one of the proximal portion and the distal portion of the reinforcing structure from the braided structure to form the at least one fixation structure.

15. The method of claim 14, wherein pulling at least one of the proximal portion and the distal portion includes pulling the proximal portion of the reinforcing structure from the braided structure to form the at least one fixation structure, wherein:

a distal end of the proximal portion of the reinforcing structure forms the free-floating end of the at least one fixation structure; and

at least some of the proximal portion of the reinforcing structure remains within the braided structure to secure the at least one fixation structure to the therapy delivery element.

16. The method of claim 12, comprising:

placing a conductor assembly including at least one conductors within the lumen of the braided structure;

electrically coupling at least one electrode of an electrode assembly with the at least one conductor;

electrically coupling at least one electrical contact of a connector assembly with the at least one conductor; and

attaching at least one of the braided structure or the reinforcing structure to at least one of the electrode assembly or the connector assembly.

17. The method of claim 16, comprising attaching both the electrode assembly and the connector assembly to the braided structure.

18. A method of making a therapy delivery element configured for at least partial insertion in a living body, the method comprising:

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

attaching at least one reinforcing structure to the braided structure; and

pulling a portion of the reinforcing structure from the braided structure to form at least one fixation structure, the 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 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.

19. The method of claim 18, comprising:

cutting the reinforcing structure at a first location to form a proximal portion of the reinforcing structure and a distal portion of the reinforcing structure; and

pulling the proximal portion of the reinforcing structure from the braided structure to form the at least one fixation structure, wherein at least some of the proximal portion of the reinforcing structure remains within the braided structure to secure the at least one fixation structure to the therapy delivery element.

20. The method of claim 18, wherein attaching the at least one reinforcing structure to the braided structure includes weaving the at least one reinforcing structure within the braided structure.