# US 11,305,111 B2 · Medical lead with preformed bias

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- Number: US 11,305,111 B2
- Document ID: US11305111B2
- Status: Granted
- Kind: B2
- Application number: 16/689,294
- Filed: 2019-11-20
- Published: 2020-04-02
- Granted: 2022-04-19
- Earliest claimed: 2009-09-30
- Assignees: Zoll Respicardia, Inc.
- Applicants: Zoll Respicardia, Inc.
- Inventors: Randy W. Westlund; Mark C. Lynn
- Web page: https://patentgrep.com/patent/US11305111B2

## CPC

- A61N 1/0558: {Anchoring or fixation means therefor}
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61N 1/057: {Anchoring means; Means for fixing the head inside the heart}
- 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

A medical electrical lead and methods of implanting medical electrical leads in lumens. Leads in accordance with the invention employ preformed biases to stabilize the lead within a lumen and to orient electrodes in a preferred orientation.

## Claims

### Claim 1

An implantable medical electrical lead comprising:
a lead body having a preformed converging helical bias extending from a proximal portion to a distal end, wherein a coil diameter decreases from the proximal portion toward the distal end of the helical bias: and
at least one electrode disposed on a distal portion of the lead body and having a length parallel to a lead body portion on which it is disposed, wherein a ratio of a coil diameter to the length of the at least one electrode is greater than or equal to 4:1, where the coil diameter is defined as a diameter of a smallest coil of the converging helical bias.

### Claim 2 (depends on 1)

The medical electrical lead of claim 1 wherein the ratio of the coil diameter to the length of the at least one electrode is greater than or equal to 5:1.

### Claim 3 (depends on 1)

The medical electrical lead of claim 1, wherein the ratio of the coil diameter to the length of the at least one electrode is greater than or equal to 6:1.

### Claim 4 (depends on 1)

The medical electrical lead of claim 1, wherein the at least one electrode comprises a plurality of electrodes, wherein the length of each electrode of the plurality of electrodes is at least partially located within a single quadrant of the converging helical bias.

### Claim 5 (depends on 4)

The medical electrical lead of claim 4, wherein at least two of the plurality of electrodes are radially offset from each other.

### Claim 6 (depends on 4)

The medical electrical lead of claim 4, wherein each of the plurality of electrodes is radially offset from the other electrodes of the plurality of electrodes.

### Claim 7 (depends on 1)

The medical electrical lead of claim 1, wherein a diameter of the converging helical bias is greater than a diameter of a lumen in which it is to be disposed in a ratio of between 1.1:1 and 1.3:1.

### Claim 8

An implantable medical electrical lead comprising:
a lead body having a preformed converging helical bias extending from a proximal portion to a distal end, wherein a coil diameter decreases from the proximal portion toward the distal end of the converging helical bias; and
a plurality of electrodes disposed on a distal portion of the lead body and having a length parallel to a lead body portion on which it is disposed, wherein at least a portion of each electrode of the plurality of electrodes is located within a single quadrant of the converging helical bias, wherein at least two of the plurality of electrodes are radially offset from each other; and wherein a ratio of the coil diameter to the length of at least one electrode is greater than or equal to 4:1, where the coil diameter is defined as a diameter of a smallest coil of the converging helical bias.

### Claim 9 (depends on 8)

The implantable medical electrical lead of claim 8, wherein the ratio of the coil diameter to the length of the at least one electrode is greater than or equal to 5:1.

### Claim 10 (depends on 8)

The implantable medical electrical lead of claim 8, wherein the ratio of the coil diameter to the length of the at least one electrode is greater than or equal to 6:1.

### Claim 11 (depends on 8)

The medical electrical lead of claim 8, wherein each of the plurality of electrodes is radially offset from the other electrodes of the plurality of electrodes.

### Claim 12 (depends on 8)

The medical electrical lead of claim 8, wherein a diameter of the converging helical bias is greater than a diameter of a lumen in which it is to be disposed in a ratio of between 1.1:1 and 1.3:1.

### Claim 13

A method of implanting a medical electrical lead, the method comprising:
inserting a lead body in a first lumen, the lead body comprising:
a lead body having a preformed converging helical bias extending from a proximal portion to a distal end, wherein a coil diameter decreases from the proximal portion toward the distal end of the converging helical bias; and
at least one electrode disposed on a distal portion of the lead body and having a length parallel to a lead body portion on which it is disposed, wherein a ratio of the coil diameter to the length of the at least one electrode is greater than or equal to 4:1, where the coil diameter is defined as a diameter of a smallest coil of the preformed converging helical bias, wherein at least a portion of each of the at least one electrode is within a single quadrant of the preformed converging helical bias; and
positioning the lead within the first lumen at a junction of the first lumen and a second lumen, the first lumen having a first diameter and the second lumen having a second diameter that is less than the first diameter such that the proximal portion of the preformed converging helical bias places a radial fixation force on the first lumen such that the preformed converging helical bias is retained in the junction and such that a tissue of interest is within the quadrant as the quadrant extends outward radially.

### Claim 14 (depends on 13)

The method of claim 13, wherein the first diameter of the first lumen corresponds to a diameter of a subclavian vein and the second diameter of the second lumen corresponds to a diameter of a right brachiocephalic vein.

### Claim 15 (depends on 14)

The method of claim 14, wherein the tissue of interest corresponds to a right phrenic nerve.

### Claim 16 (depends on 13)

The method of claim 13, wherein a diameter of the proximal portion of the preformed converging helical bias is greater than the first diameter of the first lumen in a ratio of between 1.1:1 and 1.3:1.

### Claim 17 (depends on 13)

The method of claim 13, wherein the ratio of the coil diameter to the length of the at least one electrode is greater than or equal to 5:1.

### Claim 18 (depends on 13)

The method of claim 13, wherein the ratio of the coil diameter to the length of the at least one electrode is greater than or equal to 6:1.
