# US 11,998,735 B2 · Implantable electrical leads and associated delivery systems

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- Number: US 11,998,735 B2
- Document ID: US11998735B2
- Status: Granted
- Kind: B2
- Application number: 17/900,558
- Filed: 2022-08-31
- Published: 2022-12-29
- Granted: 2024-06-04
- Earliest claimed: 2019-05-29
- Assignees: AtaCor Medical, Inc.
- Applicants: Atacor Medical, Inc.
- Inventors: Rick Sanghera; Matthew Rollins; John Beck; William Born; Shahn Sage; Alan Marcovecchio
- Web page: https://patentgrep.com/patent/US11998735B2

## CPC

- A61N 1/0587: {Epicardial electrode systems; Endocardial electrodes piercing the pericardium}
- A61N 1/0597: {Surface area electrodes, e.g. cardiac harness}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence)
- A61N 1/37: Monitoring; Protecting
- A61B 2017/00367: {Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like}
- A61B 2017/00867: {shape memory effect}
- A61N 1/362: Heart stimulators (heart defibrillators A61N1/39)
- A61N 1/372: Arrangements in connection with the implantation of stimulators
- A61N 1/3956: {Implantable devices for applying electric shocks to the heart, e.g. for cardioversion}
- 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)

## Abstract

Systems, methods, and devices to facilitate insertion of certain leads with electrode(s) into patients are described. Leads can be implanted to work in conjunction with a cardiac pacemaker or cardiac defibrillator. A lead for cardiac therapy may be inserted into an intercostal space associated with the cardiac notch of a patient. Devices for delivery may include, for example, a delivery system coupled with an electrical lead and having a handle, a component advancer and insertion tips. The handle is configured to be actuated by an operator and the component advancer is configured to advance an electrical lead into the patient. The insertion tips can be configured to close around the electrical lead within the component advancer, to push through biological tissue, and to open to enable the lead to advance into the patient. The electrical lead can also be maintained in a particular orientation during the advancement into the patient.

## Claims

### Claim 1

A delivery system comprising:
a handle configured to be actuated by an operator;
a component advancer configured to advance a component into a patient, the component advancer configured to removably engage a portion of the component, the component advancer coupled to the handle and configured to advance the component into the patient by applying a force to the portion of the component in response to actuation of the handle by the operator; and
a unitary insertion tip configured to hold a distal tip of the component when the component is placed within the component advancer, the unitary insertion tip including:
a planar surface that is parallel to a longitudinal axis of the unitary insertion tip along the entire length of the unitary insertion tip;
a distal orifice extending through a distal end of the planar surface; and
a ramped portion at a distal tip of the unitary insertion tip, the ramped portion including a curved surface opposite only the distal orifice and configured to facilitate advancement of the component into the patient in a particular direction, through the distal orifice.

### Claim 2 (depends on 1)

The system of claim 1, wherein the unitary insertion tip is configured to push through biological tissue.

### Claim 3 (depends on 1)

The system of claim 1, wherein the unitary insertion tip includes a wedge shape.

### Claim 4 (depends on 1)

The system of claim 1, wherein the unitary insertion tip is further configured to reduce exposure of the distal orifice during insertion.

### Claim 5 (depends on 1)

The system of claim 1, wherein the unitary insertion tip includes a movable cover configured to prevent biological tissue from entering the distal orifice when the unitary insertion tip pushes through the biological tissue, and wherein the movable cover is also configured to move in order to facilitate advancement of the component into the patient.

### Claim 6 (depends on 1)

The system of claim 1, wherein the delivery system includes leveraging components configured to provide a mechanical advantage or a mechanical disadvantage to the operator such that actuation of the handle by the operator makes advancing the component into the patient easier or more difficult.

### Claim 7 (depends on 6)

The system of claim 6, wherein the leveraging components include gears.

### Claim 8 (depends on 1)

The system of claim 1, wherein the component advancer includes a pusher tube coupled with the handle such that actuation of the handle by the operator causes movement of the pusher tube to push on the portion of the component to advance the component into the patient.

### Claim 9 (depends on 8)

The system of claim 8, wherein the pusher tube includes one or more coupling features configured to engage the portion of the component and configured to maintain the component in a particular orientation so as to avoid rotation of the component within the device.

### Claim 10 (depends on 8)

The system of claim 8, wherein the pusher tube includes a notch having a shape complementary to the portion of the component and configured to maintain the component in a particular orientation so as to avoid rotation of the component within the device.

### Claim 11 (depends on 1)

The system of claim 1, wherein the ramped portion is configured such that the particular direction is a lateral direction relative to a position of the insertion tip.
