Implantable medical leads, systems, and related methods with structures for aiding lead implantation

Patent metadata

Field	Value
Publication number	US-2023364416-A1
Application number	US-202318113503-A
Country	US
Kind code	A1
Filing date	Feb 23, 2023
Priority date	May 11, 2022
Publication date	Nov 16, 2023
Grant date	—

Abstract

Implantable medical leads include at least one of a polymeric stylet tube and/or a distal backfill material that is softer than is conventional at least in the area where a stylet bend will cause a distal bend in the lead. The polymeric stylet tube provides for improved torsional and column stiffness during insertion while the softer distal backfill material reduces a whipping action to increase the steerability and control of the lead during insertion. The softer backfill material may be provided alone or in combination with a harder distal backfill material. The softer backfill material may be provided as an insert that is encapsulated by the harder distal back fill material or may be provided as a backfill material that exists in a position adjacent to the harder backfill material.

First claim

What is claimed is:

1 . An implantable medical lead, comprising:
a lead body defining a first lumen, the lead body comprising a first material; a polymeric tube that is located within the first lumen for at least a portion of a length of the first lumen, the tube defining a second lumen, the tube comprising a second material having a higher durometer rating than the first material; at least one proximal connector located on a proximal end of the lead body where the tube is present; at least one distal electrode located on a distal end of the lead body where the tube is present; and at least one conductor interconnecting the at least one proximal connector and the at least one distal electrode.

2 . The implantable medical lead of claim 1 , wherein the second material has a durometer rating higher than 60 on the Shore D hardness test.

3 . The implantable medical lead of claim 1 , wherein the tube extends from a proximal tip to a distal tip of the lead body.

4 . The implantable medical lead of claim 1 , wherein the tube comprises a material comprising at least one of polyimide, acrylonitrile butadiene styrene, polyvinylidene fluoride, polycarbonate, polyethylene terephthalate, cellulose acetate, or polyvinyl chloride.

5 . The implantable medical lead of claim 1 , further comprising a first backfill material within the first lumen and adjacent the tube.

6 . The implantable medical lead of claim 5 , wherein the at least one conductor passes through the first backfill material.

7 . The implantable medical lead of claim 5 , wherein the first backfill material extends until reaching a point along the lead body that is proximal of the at least one distal electrode where the lead body contacts a complete circumference of the tube.

8 . The implantable medical lead of claim 5 , wherein the first backfill material has a durometer rating lower than 100 on the Shore A hardness scale.

9 . The implantable medical lead of claim 5 , further comprising a second backfill material within the first lumen and surrounding the first backfill material, the first backfill material having a softer durometer rating than the second backfill material.

10 . The implantable medical lead of claim 9 , wherein the second backfill material extends until reaching a point along the lead body that is proximal of the at least one distal electrode where the lead body contacts a complete circumference of the tube.

11 . The implantable medical lead of claim 9 , wherein the first backfill material is present between a point distal of the at least one distal electrode to a point proximal of the at least one distal electrode and wherein the second backfill material is present between a point along the lead body that is proximal of the at least one distal electrode where the lead body contacts a complete circumference of the tube and proximal of the first backfill material.

12 . The implantable medical lead of claim 11 , wherein the first backfill material forms a lumen and wherein the second backfill material extends through the lumen of the first backfill material.

13 . An implantable medical lead, comprising:
a lead body defining a first lumen, the lead body comprising a first material; at least one proximal connector located on a proximal end of the lead body; at least one distal electrode located on a distal end of the lead body; a first backfill material within the lumen and present at the at least one distal electrode and having a durometer rating less than 100 on the Shore A hardness scale; and at least one conductor interconnecting the at least one proximal connector and the at least one distal electrode.

14 . The implantable medical lead of claim 13 , wherein the at least one conductor passes through the first backfill material.

15 . The implantable medical lead of claim 13 , wherein the first backfill material extends until reaching a point along the lead body that is proximal of the at least one distal electrode where the lead body contacts a complete circumference of the tube.

16 . The implantable medical lead of claim 13 , further comprising a second backfill material within the first lumen and surrounding the first backfill material, the first backfill material durometer rating being softer than that of the second backfill material.

17 . An implantable medical lead, comprising:
a lead body defining a first lumen, the lead body comprising a first material; at least one proximal connector located on a proximal end of the lead body; at least one distal electrode located on a distal end of the lead body; a first backfill material within the lumen and present at the at least one distal electrode; a second backfill material within the lumen and present proximally of the first backfill material, wherein the first backfill material has a softer durometer rating than the second backfill material; and at least one conductor interconnecting the at least one proximal connector and the at least one distal electrode.

18 . The implantable medical lead of claim 17 , wherein the second backfill material surrounds the first backfill material.

19 . The implantable medical lead of claim 17 , wherein the first backfill material defines a lumen and wherein the second backfill material extends through the lumen defined by the first backfill material.

20 . The implantable medical lead of claim 17 , further comprising a polymeric tube within the first lumen and adjacent to the first backfill material and the second backfill material, the polymeric tube defining a lumen.

Assignees

• Medtronic Inc

Inventors

• Becker Damian M
• Zhang Haitao
• Hernandez Victor R
• Patel Jayesh
• Rajagopalan Chandrasekhar Ramasubramanian

Classifications

• A61N1/0551 Primary

  Spinal or peripheral nerve electrodes · CPC title

• A61N1/056

  Transvascular endocardial electrode systems · CPC title