# US 10,500,395 B2 · Delivery devices and methods for leadless cardiac devices

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- Number: US 10,500,395 B2
- Document ID: US10500395B2
- Status: Granted
- Kind: B2
- Application number: 15/354,432
- Filed: 2016-11-17
- Published: 2017-05-25
- Granted: 2019-12-10
- Earliest claimed: 2015-11-20
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Brian Soltis; Benjamin J. Haasl; Allan C. Shuros; Brian L. Schmidt; James P. Goodman
- Web page: https://patentgrep.com/patent/US10500395B2

## CPC

- A61N 1/059: {Anchoring means}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0136: {Handles therefor}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61M 2025/0006: {which can be secured against axial movement, e.g. by using a locking cuff}
- 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)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Delivery devices, systems, and methods for delivering implantable leadless pacing devices are disclosed. An example delivery device may include an intermediate tubular member and an inner tubular member slidably disposed within a lumen of the intermediate tubular member. A distal holding section may extend distally of a distal end of the intermediate tubular member and define a cavity therein for receiving an implantable leadless pacing device. The device may further include a handle assembly including at least an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member and a proximal hub portion affixed adjacent to the proximal end of the inner tubular member. A longitudinally extending groove having a proximal end and a distal end may be disposed in the intermediate hub portion. A first locking mechanism may be configured to releasably couple the intermediate hub portion and the proximal hub portion.

## Claims

### Claim 1

A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:
an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof;
an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member slidably disposed within the lumen of the intermediate tubular member;
a distal holding section extending distally of a distal end of the intermediate tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device;
a handle assembly including at least an intermediate hub portion affixed adjacent to the proximal end of the intermediate tubular member and a proximal hub portion affixed adjacent to the proximal end of the inner tubular member;
a longitudinally extending groove having a proximal end and a distal end disposed in an outer surface of the intermediate hub portion, wherein the distal end of the groove is circumferentially offset from the proximal end of the groove; and
a multi-stage deployment mechanism disposed within the handle assembly;
wherein the multi-stage deployment mechanism is configured to incrementally deploy an implantable leadless pacing device.

### Claim 2 (depends on 1)

The delivery device of claim 1, wherein the multi-stage deployment mechanism comprises a depressible button.

### Claim 3 (depends on 1)

The delivery device of claim 1, wherein the groove further comprises a hard stop positioned between the proximal and distal ends thereof.

### Claim 4 (depends on 1)

The delivery device of claim 1, wherein the multi-stage deployment mechanism includes an inwardly extending mating feature configured to be disposed within the groove.

### Claim 5 (depends on 1)

The delivery device of claim 1, further comprising an outer tubular member including a lumen extending from a proximal end to a distal end thereof and a distal hub portion affixed adjacent to the proximal end of the outer tubular member.

### Claim 6 (depends on 5)

The delivery device of claim 5, further comprising a locking mechanism disposed within the handle assembly.

### Claim 7 (depends on 6)

The delivery device of claim 6, wherein the locking mechanism is configured to releasably couple the intermediate hub portion and the distal hub portion.

### Claim 8

A delivery device for delivering an implantable leadless pacing device, the delivery device comprising:
an outer tubular member including a lumen extending from a proximal end to a distal end thereof;
an intermediate tubular member including a lumen extending from a proximal end to a distal end thereof, the intermediate tubular member slidably disposed within the lumen of the outer tubular member;
an inner tubular member including a lumen extending from a proximal end to a distal end thereof, the inner tubular member slidably disposed within the lumen of the intermediate tubular member;
a distal holding section extending distally of a distal end of the intermediate tubular member, the distal holding section defining a cavity therein for receiving an implantable leadless pacing device;
a handle assembly including at least a first hub portion affixed adjacent to the proximal end of the outer tubular member, an intermediate second hub portion affixed adjacent to the proximal end of the intermediate tubular member, and a third hub portion affixed adjacent to the proximal end of the inner tubular member; and
a multi-stage deployment mechanism disposed within the handle assembly;
wherein the multi-stage deployment mechanism is configured to incrementally deploy an implantable leadless pacing device.

### Claim 9 (depends on 8)

The delivery device of claim 8, wherein the multi-stage deployment mechanism comprises a depressible button.

### Claim 10 (depends on 8)

The delivery device of claim 8, further comprising a longitudinally extending groove having a proximal end and a distal end disposed in an outer surface of the second hub portion, wherein the distal end of the groove is circumferentially offset from the proximal end of the groove.

### Claim 11 (depends on 10)

The delivery device of claim 10, wherein the groove further comprises a hard stop positioned between the proximal and distal ends thereof.

### Claim 12 (depends on 10)

The delivery device of claim 10, wherein the multi-stage deployment mechanism includes an inwardly extending mating feature configured to be disposed within the groove.

### Claim 13 (depends on 8)

The delivery device of claim 8, further comprising a locking mechanism disposed within the handle assembly.

### Claim 14 (depends on 13)

The delivery device of claim 13, wherein the locking mechanism is configured to releasably couple the second hub portion and the first hub portion.

### Claim 15 (depends on 13)

The delivery device of claim 13, wherein the locking mechanism comprises a rotatable retaining ring.
