LEAD WITH BRAIDED REINFORCEMENT

• US 20140068936A1
• Filed: 11/12/2013
• Published: 03/13/2014
• Est. Priority Date: 08/10/2012
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Swoyer, John M., Finley, James
• Granted Patent: US 9,597,492 B2
• Time in Patent Office: Days
• US Class Current: 29/877
• 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: Y10T 29/49208 by assembling plural parts
• CPC Class Codes: Y10T 29/4921 with bonding

Abstract

A therapy delivery element configured for at least partial insertion in a living body. A braided structure surrounds the conductor assembly. A distal end of the braided structure is attached to an electrode assembly and a free floating proximal end is located near a connector assembly. An outer tubing surrounds the braided structure. The outer tubing includes a proximal end attached to the connector assembly and a distal end attached to the braided structure near the electrode assembly. A proximal tension force applied to the connector assembly acts substantially on the outer tubing and the conductor assembly and a proximal tension force applied to the free floating proximal end acts substantially on the braided structure.

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 a braided structure with a lumen;

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

positioning an outer tubing around the braided structure and the conductor assembly;

electrically coupling electrodes on an electrode assembly to the conductors at a distal end of the conductor assembly;

electrically coupling electrical connectors on a connector assembly to the conductors at a proximal end of the conductor assembly;

attaching the braided structure to the electrode assembly, while leaving a proximal end of the braided structure free floating in the outer tubing, wherein the free floating proximal end of the braided structure is unattached to, but disposed within, the outer tubing;

attaching a proximal end of the outer tubing to the connector assembly; and

bonding a distal end of the outer tubing to the braided structure near the electrode assembly, wherein;

with a first proximal tension force applied to the connector assembly, a first elongation of the therapy delivery element substantially corresponds to a first elongation of the outer tubing and the conductor assembly

with a second proximal tension force applied to the free floating proximal end of the braided structure, a second elongation of the therapy delivery element substantially corresponds to a second elongation of the braided structure; and

with the first proximal tension force equal to the second proximal tension force, the first elongation of the therapy delivery element with the first proximal tension force applied to the connector assembly is greater than the second elongation of the therapy delivery element with the second proximal tension force applied to the free floating proximal end of the braided structure.

2. The method of claim 1, comprising:

applying a tension force to the proximal end of the braided structure; and

transmitting the tension force substantially to the electrode assembly independent of the outer tubing.

3. The method of claim 1, comprising applying the first proximal tension force to the connector assembly such that the therapy delivery element exhibits a percentage elongation generally corresponding to a percentage elongation of the outer tubing and the conductor assembly.

4. The method of claim 1, comprising:

applying a first axial force to axially deform of the therapy delivery element between the connector assembly and the distal end of the outer tubing; and

applying a second axial force to axially deform the therapy delivery element between the free floating proximal end and the electrode assembly, wherein the first axial force is 10% or less than the second axial force.

5. The method of claim 1, comprising bonding an inner tubing to the braided structure.

6. The method of claim 1, comprising bonding an inner tubing to the braided structure, wherein the outer tubing surrounds the inner tubing, an inner diameter of the outer tubing being greater than an outer diameter of the inner tubing to form a gap between the inner tubing and the outer tubing.

7. The method of claim 1, wherein bonding the distal end of the outer tubing to the braided structure includes bonding the outer tubing to the braided structure such that the outer tubing is configured to be elongatable independently of the braided structure.

8. The method of claim 1, comprising melting a thermoplastic material into engagement with the braided structure.

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

locating a conductor assembly including at least one conductor within a lumen of a braided structure;

positioning an outer tubing around the braided structure;

electrically coupling at least one electrode of an electrode assembly to the at least one conductor at a distal end of the conductor assembly;

electrically coupling at least one electrical connector of a connector assembly to the at least one conductor at a proximal end of the conductor assembly;

attaching the braided structure to the electrode assembly, the braided structure including a free floating proximal end, wherein the free floating proximal end of the braided structure is unattached to, but disposed within, the outer tubing; and

attaching a proximal end of the outer tubing to the connector assembly, wherein;

with a first proximal tension force applied to the connector assembly, a first elongation of the therapy delivery element substantially corresponds to a first elongation of the outer tubing and the conductor assembly;

with a second proximal tension force applied to the free floating proximal end of the braided structure, a second elongation of the therapy delivery element substantially corresponds to a second elongation of the braided structure; and

with the first proximal tension force equal to the second proximal tension force, the first elongation of the therapy delivery element with the first proximal tension force applied to the connector assembly is greater than the second elongation of the therapy delivery element with the second proximal tension force applied to the free floating proximal end of the braided structure.

10. The method of claim 9, comprising bonding a distal end of the outer tubing to the braided structure proximate the electrode assembly.

11. The method of claim 9, comprising braiding a plurality of fibers together to form the braided structure.

12. The method of claim 9, comprising bonding an inner tubing to the braided structure.

13. The method of claim 9, comprising bonding an inner tubing to the braided structure, wherein the outer tubing surrounds the inner tubing, an inner diameter of the outer tubing being greater than an outer diameter of the inner tubing to form a gap between the inner tubing and the outer tubing.

14. The method of claim 9, wherein bonding the distal end of the outer tubing to the braided structure includes bonding the outer tubing to the braided structure such that the outer tubing is configured to be elongatable independently of the braided structure.

15. The method of claim 9, comprising melting a thermoplastic material into engagement with the braided structure.

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

locating a conductor assembly including a conductor within a lumen of a braided structure;

positioning an outer tubing around the braided structure;

electrically coupling an electrode of an electrode assembly to the conductor at a distal end of the conductor assembly;

electrically coupling an electrical connector of a connector assembly to the conductor at a proximal end of the conductor assembly;

attaching the braided structure to the electrode assembly, the braided structure including a free floating proximal end, wherein the free floating proximal end of the braided structure is unattached to, but disposed within, the outer tubing; and

attaching a proximal end of the outer tubing to the connector assembly, wherein;

with a first proximal tension force applied to the connector assembly, a first elongation of the therapy delivery element substantially corresponds to a first elongation of the outer tubing and the conductor assembly; and

with a second proximal tension force applied to the free floating proximal end of the braided structure, a second elongation of the therapy delivery element substantially corresponds to a second elongation of the braided structure.

17. The method of claim 16, wherein an axial force required to fully stretch the therapy delivery element between the connector assembly and the distal end of the outer tubing is less than about 10% of the yield strength between the free floating proximal end of the braided structure and the electrode assembly.

18. The method of claim 16, wherein, with the first proximal tension force equal to the second proximal tension force, a yield strength of the therapy delivery element with the second proximal tension force applied to the free floating proximal end of the braided structure is at least 5 times greater than the yield strength of the therapy delivery element with the first proximal tension force applied to the connector assembly.

19. The method of claim 16, comprising bonding an inner tubing to the braided structure, wherein the outer tubing surrounds the inner tubing, an inner diameter of the outer tubing being greater than an outer diameter of the inner tubing to form a gap between the inner tubing and the outer tubing.

20. The method of claim 16, wherein bonding the distal end of the outer tubing to the braided structure includes bonding the outer tubing to the braided structure such that the outer tubing is configured to be elongatable independently of the braided structure.