# US 2014/0155966 A1 · Implantable lead with body profile optimized for implant environment

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- Number: US 2014/0155966 A1
- Document ID: US20140155966A1
- Status: Published application
- Kind: A1
- Application number: 13/691,028
- Filed: 2012-11-30
- Published: 2014-06-05
- Earliest claimed: 2012-11-30
- Assignees: Pacesetter, Inc.
- Applicants: Pacesetter, Inc.
- Inventors: Dorab N. Sethna; Steven R. Conger
- Web page: https://patentgrep.com/patent/US20140155966A1

## CPC

- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61B 5/29: for permanent or long-term implantation
- A61B 5/686: {Permanently implanted devices, e.g. pacemakers, other stimulators, biochips (A61B5/6861 takes precedence)}
- A61B 5/6869: {Heart}
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- Y10T 156/10: Methods of surface bonding and/or assembly therefor
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

Implementations described and claimed herein provide an implantable lead optimized for an implant environment and methods of manufacturing such implantable leads. The implantable lead includes an insulation layer having one or more transitions along a length of the insulation layer from a proximal end to a distal end. Each of the transitions is a seamless change from a section of the insulation layer having a set of performance characteristics to another section of the insulation layer having a different set of performance characteristics.

## Claims

### Claim 1

An implantable lead optimized for an implant environment, the implantable lead comprising:
an insulation layer having one or more transitions along a length of the insulation layer from a proximal end to a distal end, each of the transitions being a seamless change from a section of the insulation layer having a set of performance characteristics to another section of the insulation layer having a different set of performance characteristics;
wherein a first section of the insulation layer is disposed at a distal portion of the insulation layer and a second section of the insulation layer is disposed proximal to the first section of the insulation layer, wherein the first section of the insulation layer has a first set of performance characteristics including a first wall thickness and the second section of the insulation layer has a second set of performance characteristics including a second wall thickness, and wherein the second wall thickness is greater than the first wall thickness.

### Claim 2 (depends on 1)

The implantable lead of claim 1, wherein the performance characteristics further include material type and durometer.

### Claim 3

(canceled)

### Claim 4

(canceled)

### Claim 5

(canceled)

### Claim 6

(canceled)

### Claim 7

(canceled)

### Claim 8

(canceled)

### Claim 9

(canceled)

### Claim 10 (depends on 1)

The implantable lead of claim 1, wherein the one or more transitions includes a first transition from a first section to a second section having a local diameter decrease.

### Claim 11 (depends on 1)

The implantable lead of claim 1, further comprising a component supported on the lead body and the component is located at the second section.

### Claim 12 (depends on 11)

The implantable lead of claim 11, wherein the component includes a ring electrode, sensor or fixation mechanism.

### Claim 13

(canceled)

### Claim 14

An implantable lead insulation layer comprising:
a first section having a first set of performance characteristics;
a second section having a second set of performance characteristics that is different from the first set of performance characteristics; and
a first transition between the first section and the second section, the first transition preventing the first set of performance characteristics from compromising the second set of set of performance characteristics.

### Claim 15 (depends on 14)

The implantable lead insulation layer of claim 14, wherein the transition is seamless.

### Claim 16 (depends on 14)

The implantable lead insulation layer of claim 14, wherein the first and second sets of performance characteristics include wall thickness, material type, and durometer.

### Claim 17 (depends on 14)

The implantable lead insulation layer of claim 14, wherein the first set of performance characteristics includes a first wall thickness and the second set of performance characteristics includes a second wall thickness, the first wall thickness being different than the second wall thickness.

### Claim 18 (depends on 17)

The implantable lead insulation layer of claim 17, wherein the first wall thickness is greater than the second wall thickness.

### Claim 19 (depends on 18)

The implantable lead insulation layer of claim 18, wherein the first wall thickness is proximal the second wall thickness.

### Claim 20 (depends on 14)

The implantable lead insulation layer of claim 14, wherein the first set of performance characteristics includes a first material type and the second set of performance characteristics includes a second material type, the first material type being different than the second material type.

### Claim 21 (depends on 20)

The implantable lead insulation layer of claim 20, wherein the first material type is robust relative to the second material type and the second material type is flexible relative to the first material type.

### Claim 22 (depends on 21)

The implantable lead insulation layer of claim 21, wherein the first material type is proximal the second material type.

### Claim 23 (depends on 14)

The implantable lead insulation layer of claim 14 further comprising:
a second transition to a third section having a third set of performance characteristics.

### Claim 24 (depends on 23)

The implantable lead insulation layer of claim 23, wherein the third set of performance characteristics includes a local diameter increase.

### Claim 25 (depends on 23)

The implantable lead insulation layer of claim 23, wherein the third set of performance characteristics includes abrasion resistance.

### Claim 26

A method for manufacturing an implantable lead optimized for an implant environment, the method comprising:
obtaining a plurality of insulation layer sections, each insulation layer section having a set of performance characteristics based on a local environment in which the insulation layer section is to be implanted;
positioning the plurality of insulation layer sections relative to each other; and
fusing the plurality of insulation layer sections together such that one or more transitions are formed along a length of a composite insulation layer.

### Claim 27 (depends on 26)

The method claim 26, wherein the plurality of insulation layer sections are fused together using reflow techniques.

### Claim 28

The method of 26, wherein the plurality of insulation layer sections each include a thermoset material that is not capable of melt-reflow.

### Claim 29 (depends on 26)

The method of claim 26, wherein the performance characteristics include wall thickness, material type, and durometer.

### Claim 30 (depends on 26)

The method of claim 26, wherein the one or more transitions includes a first transition from a first insulation layer section having a first set of performance characteristics to a second insulation layer section having a second set of performance characteristics that are different than the first set of performance characteristics.

### Claim 31 (depends on 30)

The method of claim 30, wherein the first set of performance characteristics includes a first wall thickness and the second set of performance characteristics includes a second wall thickness, the first wall thickness being greater than the second wall thickness.

### Claim 32 (depends on 31)

The method of claim 31, wherein the first wall thickness is proximal the second wall thickness.

### Claim 33 (depends on 30)

The method of claim 30, wherein the first set of performance characteristics includes a first material type and the second set of performance characteristics includes a second material type, the first material type being robust relative to the second material type and the second material type being flexible relative to the first material type.

### Claim 34 (depends on 33)

The method of claim 33, wherein the first material type is proximal the second material type.

### Claim 35 (depends on 26)

The method of claim 26, wherein at least one transition of the one or more transitions is seamless.
