# US 10,369,354 B2 · Systems and method for anchoring a lead for neurostimulation of a target anatomy

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- Number: US 10,369,354 B2
- Document ID: US10369354B2
- Status: Granted
- Kind: B2
- Application number: 15/596,761
- Filed: 2017-05-16
- Published: 2017-11-23
- Granted: 2019-08-06
- Earliest claimed: 2016-05-17
- Assignees: Boston Scientific Neuromodulation Corporation
- Applicants: Boston Scientific Neuromodulation Corporation
- Inventors: Paul Keith Barner
- Web page: https://patentgrep.com/patent/US10369354B2

## CPC

- A61N 1/0558: {Anchoring or fixation means therefor}
- A61N 1/0551: {Spinal or peripheral nerve electrodes}
- A61N 1/36057: {adapted for stimulating afferent nerves}
- A61N 1/36062: {Spinal stimulation}
- A61N 1/36182: {Direction of the electrical field, e.g. with sleeve around stimulating electrode}
- A61N 1/37235: {Aspects of the external programmer}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61N 1/3754: {Feedthroughs}
- A61N 1/3787: {from an external energy source}
- 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 lead having proximal and distal ends. At the distal end, a first branch includes a first biasing member and a first insulation covering. The first biasing member is disposed within the first insulation covering, which in turn includes a first inner surface. At the distal end, a second branch includes a second biasing member and a second insulation covering. The second biasing member is disposed within the second insulation covering, which in turn includes a second inner surface. The branches define a receiving channel and a stimulation region. The biasing members are movable away from each other to receive a target anatomy through the receiving channel and biasly movable toward each other to retain the target anatomy within the stimulation region. An electrode is disposed on one or both of the inner surfaces adjacent to the stimulation region, and is operable to stimulate the target anatomy.

## Claims

### Claim 1

An electrical stimulation lead having a proximal end and a distal end, the lead comprising:
at the distal end of the lead, a first branch having a first biasing member and a first insulation covering, the first biasing member disposed within the first insulation covering, the first insulation covering having a first inner surface;
at the distal end of the lead, a second branch having a second biasing member and a second insulation covering, the second biasing member disposed within the second insulation covering, the second insulation covering having a second inner surface,
wherein the first and second branches define a receiving channel and a stimulation region proximal to the receiving channel,
wherein the first and second biasing members are, upon application of a force to separate the first and second biasing members, movable away from each other to receive a target anatomy through the receiving channel and, upon removal of the force, are biased to automatically move back toward each other to retain the target anatomy within the stimulation region; and
at least one electrode disposed on one or both of the first inner surface or the second inner surface, the at least one electrode disposed adjacent to the stimulation region, wherein the at least one electrode is operable to electrically stimulate the target anatomy.

### Claim 2 (depends on 1)

The lead of claim 1, wherein the first and second biasing members comprise a shape memory material.

### Claim 3 (depends on 2)

The lead of claim 2, wherein the shape memory material is nitinol.

### Claim 4 (depends on 1)

The lead of claim 1, wherein at least one of the first or second biasing member is electrically coupled to at least one of the at least one electrode.

### Claim 5 (depends on 1)

The lead of claim 1, further comprising a plurality of conductors disposed in one or both of the first or second insulation coverings.

### Claim 6 (depends on 1)

The lead of claim 1, wherein the first branch includes a first hook portion.

### Claim 7 (depends on 6)

The lead of claim 6, wherein the second branch includes a second hook portion.

### Claim 8 (depends on 7)

The lead of claim 7, wherein the first and second hook portions define the receiving channel.

### Claim 9 (depends on 1)

An electrical stimulation system comprising:
the lead of claim 1; and
a control module coupleable to the lead, the control module having a housing and an electronic subassembly disposed in the housing.

### Claim 10

An electrical stimulation lead having a proximal end and a distal end, the lead comprising:
at the distal end of the lead, a first biasing member having a first branch and a second branch extending distally from the first branch;
at the distal end of the lead, a second biasing member having a third branch and a fourth branch extending distally from the third branch,
wherein the second and fourth branches are angled to define a receiving channel and a throat region with a throat width,
wherein the first and third branches define a stimulation region proximal to the receiving channel,
wherein the first and second biasing members are, upon application of a force to separate the first and second biasing members, movable away from each other to increase the throat width and receive a target anatomy through the throat region, and
wherein the first and second biasing members are, upon removal of the force, are biased to automatically move back toward each other to retain the target anatomy within the stimulation region; and
at least one electrode disposed on one or both of the first or second biasing members, the at least one electrode disposed adjacent to the stimulation region, wherein the at least one electrode is operable to electrically stimulate the target anatomy.

### Claim 11 (depends on 10)

The lead of claim 10, wherein the first and second biasing members comprise a shape memory material.

### Claim 12 (depends on 11)

The lead of claim 11, wherein the shape memory material is nitinol.

### Claim 13

An electrical stimulation lead having a proximal end and a distal end, the lead comprising, the lead comprising:
a housing located at the distal end of the lead;
an anchor member having a first configuration disposed within the housing;
a lumen coupled to the housing; and
an anchor actuation device extending through the lumen and directly coupled to the anchor member, wherein the anchor actuation device is movable to distally urge the anchor member out of the housing into a deployed configuration in a vicinity of a target anatomy, and wherein the anchor member entangles with patient tissue to secure the lead in the vicinity of the target anatomy.

### Claim 14 (depends on 13)

The lead of claim 13, wherein the anchor member is made from nitinol.

### Claim 15 (depends on 13)

The lead of claim 13, wherein at anchor member is a ribbon member that is helically wound when in an un-deployed configuration.

### Claim 16 (depends on 13)

The lead of claim 13, wherein the anchor member is a coil-shaped anchor member.

### Claim 17 (depends on 16)

The lead of claim 16, wherein the coil-shaped anchor member includes a pigtail-shaped configuration when in a deployed configuration.

### Claim 18 (depends on 17)

The lead of claim 17, wherein the pigtail-shaped configuration engages a patient's tissue in a vicinity of the target anatomy for neurostimulation.

### Claim 19 (depends on 13)

The lead of claim 13 wherein the anchor actuation device is movable to retract the anchor member into an un-deployed configuration.

### Claim 20 (depends on 13)

An electrical stimulation system comprising:
the lead of claim 13; and
a control module coupleable to the lead, the control module having a housing and an electronic subassembly disposed in the housing.
