# US 9,050,454 B2 · Electrically conductive and mechanically supportive polymer materials for biomedical leads

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- Number: US 9,050,454 B2
- Document ID: US9050454B2
- Status: Granted
- Kind: B2
- Application number: 14/071,065
- Filed: 2013-11-04
- Published: 2014-02-27
- Granted: 2015-06-09
- Earliest claimed: 2010-03-09
- Assignees: Biotectix, LLC
- Applicants: Biotectix, LLC
- Inventors: Jeffrey Hendricks; Sarah Richardson-Burns; Amir Tehrani
- Web page: https://patentgrep.com/patent/US9050454B2

## CPC

- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

An implantable medical lead connecting to a device header of a medical apparatus and having an electrode, a conductor, and a conductive polymer layer formed on at least a portion of the medical lead. An insulative sheath surrounds the conductive polymer layer for electrical insulation. The conductive polymer layer and insulative sheath maintain mechanical and electrical continuity of the lead in the event of fracture. The conductive polymer layer is composed of conductive polymers and may contain one or more dopants for improving electrical characteristics, mechanical characteristics, and processability.

## Claims

### Claim 1

An implantable medical lead comprising:
a conducting electrode comprising:
a proximal end;
a distal end;
a conductive polymer connected to provide an electrically conductive path from the proximal end to the distal end;
an insulating sheath surrounding the conductive polymer to electrically insulate a surface of the conductive polymer;
a second conducting electrode comprising a second conductive polymer positioned along the insulating sheath;
a second insulating sheath surrounding the second conductive polymer to electrically insulate a surface of the second conductive polymer,
wherein either: (a) the conductive polymer penetrates the insulating sheath to a depth that is equal to or less than the wall thickness of the insulating sheath; (b) the conductive polymer penetrates a length equal to or less than a total length of the insulating sheath; or (c) the conductive polymer penetrates a surface area equal to or less than a total surface area of the insulating sheath.

### Claim 2 (depends on 1)

The implantable medical lead of claim 1, wherein the conductive polymer further comprises a dopant.

### Claim 3 (depends on 2)

The implantable medical lead of claim 2, wherein the conductive polymer is a reaction product of a polymerization mixture comprising about 30-100% (w/w) of conducting monomer, and 0-70% (w/w) of the dopant based on the total weight of the conducting monomer and the dopant in the polymerization mixture.

### Claim 4 (depends on 2)

The implantable medical lead of claim 2, wherein the conductive polymer is a reaction product of a polymerization mixture comprising about 60-80% (w/w) of conducting monomer, and 20-40% (w/w) of the dopant based on the total weight of the conducting monomer and the dopant in the polymerization mixture.

### Claim 5 (depends on 2)

The implantable medical lead of claim 2, wherein the conductive polymer is a reaction product of a polymerization mixture comprising about 90-100% (w/w) of conducting monomer, and 0-10% (w/w) of the dopant based on the total weight of the conducting monomer and the dopant in the polymerization mixture.

### Claim 6 (depends on 2)

The implantable medical lead of claim 2, wherein the dopant comprises one or more of the following electrical dopants to impart conductivity: metal particles, metal nanoparticles, electroplated metals, carbon nanotubes, carbon fibers, graphite, an anionic molecule, a salt, a non-polymeric conductive macromolecule, or a polymeric anion.

### Claim 7 (depends on 2)

The implantable medical lead of claim 2, wherein the dopant comprises one or more of the following mechanical dopants to improve mechanical strength of the conductive polymer: polystyrene sulfonate (PSS), polyacrylamide, polyacrylate, carbon fibers, carbon nanotubes, a copolymer with anionic segments, or a crosslinking agent.

### Claim 8 (depends on 2)

The implantable medical lead of claim 2, wherein the dopant comprises one or more of the following deposition facilitator dopants to improve processability of the conductive polymer: a counterion, a surfactant, a photo-initiator, an oxidizing agent, a polymeric anion, or a copolymer with anionic segments.

### Claim 9 (depends on 2)

A method of making the implantable medical lead of claim 2, the method comprising:
exposing a surface of the insulating sheath to a polymerization mixture and an oxidizing agent polymerization initiator to form the conductive polymer on the surface of the insulating sheath, the polymerization mixture containing a conducting monomer and the dopant;
connecting the conductive polymer to the distal end and the proximal end of the conducting electrode to form the electrically conductive path.

### Claim 10 (depends on 9)

The method of claim 9, further comprising exposing a surface of a second insulating sheath to the polymerization mixture and the oxidizing agent polymerization initiator to form a second conductive polymer on the surface of the second insulating sheath, wherein the second insulating sheath is of larger diameter than the insulating sheath; and inserting the insulating sheath into the lumen of the second insulating sheath.

### Claim 11 (depends on 10)

The method of claim 10, further comprising heating the second insulating sheath after the insulating sheath is inserted into the lumen.

### Claim 12 (depends on 11)

The method of claim 11, wherein the heating is annealing.

### Claim 13 (depends on 9)

The method of claim 9, wherein the polymerization mixture contains the oxidizing agent polymerization initiator.

### Claim 14 (depends on 13)

The method of claim 13, wherein the conducting monomer is present in the polymerization mixture in a concentration of 0.001 to 10% (w/v) based on the total weight of the mixture.

### Claim 15 (depends on 13)

The method of claim 13, wherein the insulating sheath is exposed to the polymerization mixture for 1 to 60 minutes.

### Claim 16 (depends on 9)

The method of claim 9, wherein the surface of the insulating sheath is exposed to the polymerization mixture before the surface is exposed to the oxidizing agent polymerization initiator.

### Claim 17 (depends on 16)

The method of claim 16, wherein the insulating sheath is exposed to the oxidizing agent polymerization initiator for 1 to 60 minutes.

### Claim 18 (depends on 9)

The method of claim 9, wherein the oxidizing agent polymerization initiator is present in solution in a concentration ranging from 0.1-10% (w/v).

### Claim 19 (depends on 9)

The method of claim 9, wherein the polymerization mixture comprises a solvent, and the solvent comprises water or an organic solvent.

### Claim 20 (depends on 19)

The method of claim 19, wherein the organic solvent comprises acetone, an alcohol, dimethyl sulfoxide, or dichloromethane.

### Claim 21 (depends on 9)

The method of claim 9, wherein the conducting monomer comprises one or more of, thiophene, ethylenedioxythiophene (EDOT), aniline, a natural or synthetic melanin, or a derivative thereof.

### Claim 22 (depends on 9)

The method of claim 9, wherein the insulating sheath is a film, foam, sheet, mesh, or fabric made of one or more of the following insulating materials: silicone, polyurethane, polyimide, ethylene tetrafluoroethylene, polytetrafluoroethylene, poly ether ether ketone, or polyolefin.

### Claim 23 (depends on 1)

The implantable medical lead of claim 1, wherein the insulating sheath is a film, foam, sheet, mesh, or fabric made of one or more of the following insulating materials: silicone, polyurethane, polyimide, ethylene tetrafluoroethylene, polytetrafluoroethylene, poly ether ether ketone, or polyolefin.

### Claim 24 (depends on 1)

The implantable medical lead of claim 1, wherein the electrical connections are soldered, welded, pressure fitted, or crimped connections.

### Claim 25 (depends on 1)

The implantable medical lead of claim 1, wherein the conductive polymer comprises one or more electrical dopants, mechanical dopants, or processability dopants.

### Claim 26 (depends on 1)

The implantable medical lead of claim 1, wherein one or more of the conductive polymer and the insulating sheath is modified by exposure to oxidizing chemicals, acids, or a combination thereof to impart one or more of the following properties: wettability, permeability, porosity, adhesion, or texture.

### Claim 27 (depends on 1)

The implantable medical lead of claim 1, wherein one or more of the conductive polymer and the insulating sheath is modified by exposure to a silane, a self-assembled monolayer, or a combination thereof to impart one or more of the following surface properties: wettability, permeability, porosity, adhesion, or texture.

### Claim 28 (depends on 1)

The implantable medical lead of claim 1, wherein the conductive polymer penetrates the insulating sheath to a depth that is equal to or less than the wall thickness of the insulating sheath.

### Claim 29 (depends on 1)

The implantable medical lead of claim 1, wherein the conductive polymer penetrates a length equal to or less than a total length of the insulating sheath.

### Claim 30 (depends on 1)

The implantable medical lead of claim 1, wherein the conductive polymer penetrates a surface area equal to or less than a total surface area of the insulating sheath.

### Claim 31 (depends on 1)

The implantable medical lead of claim 1 wherein the insulating sheath and the second insulating sheath further comprise coaxial sheaths.

### Claim 32 (depends on 1)

The implantable medical lead of claim 1 wherein the conductive polymer is positioned along and insulated from the second conductive polymer inside the implantable medical lead.

### Claim 33 (depends on 1)

The implantable medical lead of claim 1 wherein the conductive polymer comprises one or more of the following conducting materials: polypyrrole, polythiophene, polyethylenedioxythiophene (PEDOT), polyaniline, polyacetylene, natural or synthetic melanins, or a derivative, copolymer or homopolymer thereof.

### Claim 34 (depends on 33)

The implantable medical lead of claim 33 wherein the conductive polymer comprises one or more of the following conducting materials: polythiophene, polyethylenedioxythiophene (PEDOT), polyaniline, natural or synthetic melanins, or a derivative, copolymer or homopolymer thereof.