# US 12,109,371 B2 · Stabilizer for a delivery system

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- Number: US 12,109,371 B2
- Document ID: US12109371B2
- Status: Granted
- Kind: B2
- Application number: 18/073,760
- Filed: 2022-12-02
- Published: 2023-03-30
- Granted: 2024-10-08
- Earliest claimed: 2018-10-04
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Deena Walid Jamal; Hieu Minh Luong; Garrett Dallas Johnson; Tarannum Ishaq Gutierrez; Matthew Michael Becerra; Karen Fromell Nesbitt
- Web page: https://patentgrep.com/patent/US12109371B2

## CPC

- A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers}
- A61B 90/50: Supports for surgical instruments, e.g. articulated arms
- A61B 90/57: Accessory clamps
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61B 34/30: Surgical robots
- A61B 90/11: with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61B 2034/304: {including a freely orientable platform, e.g. so called 'Stewart platforms'}
- A61B 2090/061: {for measuring dimensions, e.g. length}
- A61B 2090/0807: {Indication means}
- A61B 2090/508: {with releasable brake mechanisms}
- A61B 2090/571: {for clamping a support arm to a bed or other supports}
- A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)}
- A61M 25/0136: {Handles therefor}
- A61M 2205/0272: Electro-active or magneto-active materials
- A61M 2209/01: Remote controllers for specific apparatus
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Disclosed herein are embodiments of stabilizers for use in delivering a replacement heart valve. The stabilizers can receive a portion of a delivery system, such as a handle, to prevent unwanted motion of the delivery system. The stabilizer can include a linear actuator for adjusting a position of the delivery system once held within the stabilizer.

## Claims

### Claim 1

A stabilizer for a heart valve delivery system, the stabilizer comprising:
an elongated main body comprising a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end, the elongated main body comprising:
a generally flat base plate extending between the proximal end and the distal end;
a first angled surface located on top of the base plate, the first angled surface being sloped downwardly toward the distal end; and
a second angled surface located on top of the base plate and spaced longitudinally away from and proximal of the first angled surface, the second angled surface being sloped downwardly toward the distal end;
a hub nest attachable on top of the first angled surface, the hub nest comprising an extension extending upwards from the first angled surface, the extension configured to releasably hold a sheath hub of the heart valve delivery system;
a handle carriage on top of the second angled surface, the handle carriage comprising a track attachable to the second angled surface and a heart valve delivery system clamp configured to longitudinally travel along the track, wherein the heart valve delivery system clamp is configured to releasably hold a handle of the heart valve delivery system; and
a base adapter, wherein the distal end of the main body is configured to releasably connect with the base adapter,
wherein:
the base adapter comprises a pair of proximally extending arms and an upper tab configured to receive distally extending tabs of the main body to prevent upward motion of the main body;
the first angled surface and the second angled surface are configured to be individually angularly adjusted with respect to the flat base plate;
the handle carriage comprises a first knob configured to longitudinally translate the heart valve delivery system clamp along the track and a second knob configured to open and close the heart valve delivery system clamp; and
the first angled surface has a lower height relative to the flat base plate than the second angled surface.

### Claim 2 (depends on 1)

The stabilizer of claim 1, wherein a motor is configured to translate the heart valve delivery system clamp along the track, and wherein the motor is configured to open and close the heart valve delivery system clamp.

### Claim 3 (depends on 2)

The stabilizer of claim 2, wherein the motor is configured to be operated remotely.

### Claim 4

A stabilizer for a heart valve delivery system, the stabilizer comprising:
an elongated main body comprising a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end, the elongated main body comprising:
a generally flat base plate extending between the proximal end and the distal end;
a first angled surface located on top of the base plate, the first angled surface being sloped downwardly toward the distal end; and
a second angled surface located on top of the base plate and spaced longitudinally away from and proximal of the first angled surface, the second angled surface being sloped downwardly toward the distal end;
a hub nest attachable on top of the first angled surface, the hub nest comprising an extension extending upwards from the first angled surface, the extension configured to releasably hold a sheath hub of the heart valve delivery system;
a handle carriage on top of the second angled surface, the handle carriage comprising a track attachable to the second angled surface and a heart valve delivery system clamp configured to longitudinally travel along the track, wherein the heart valve delivery system clamp is configured to releasably hold a handle of the heart valve delivery system;
a travel screw located within the track, wherein a portion of the heart valve delivery system clamp is located within the track and interfaces with the travel screw to cause longitudinal travel of the heart valve delivery system clamp along the track; and
a base adapter, wherein the distal end of the main body is configured to releasably connect with the base adapter.

### Claim 5 (depends on 4)

The stabilizer of claim 4, wherein the base adapter comprises a pair of proximally extending arms and an upper tab configured to receive distally extending tabs of the main body to prevent upward motion of the main body.

### Claim 6 (depends on 4)

The stabilizer of claim 4, wherein the first angled surface and the second angled surface are configured to be individually angularly adjusted with respect to the base plate.

### Claim 7 (depends on 4)

The stabilizer of claim 4, wherein the handle carriage comprises a first knob configured to longitudinally translate the heart valve delivery system clamp along the track thereby allowing fine adjustments of the heart valve delivery system and a second knob configured to open and close the heart valve delivery system clamp, the heart valve delivery system clamp allowing rotation of the heart valve delivery system when not fully locked and holding the heart valve delivery system firmly when fully locked.

### Claim 8 (depends on 4)

The stabilizer of claim 4, wherein the first angled surface has a lower height relative to the base plate than the second angled surface.

### Claim 9 (depends on 4)

The stabilizer of claim 4, wherein a motor is configured to translate the heart valve delivery system clamp along the track, and wherein the motor is configured to open and close the heart valve delivery system clamp.

### Claim 10 (depends on 9)

The stabilizer of claim 9, wherein the motor is configured to be operated remotely.

### Claim 11 (depends on 4)

The stabilizer of claim 4, wherein the heart valve delivery system clamp comprises a stationary clamp and a moving clamp, wherein the stationary clamp and the moving clamp are connected with a screw or bolt.

### Claim 12 (depends on 11)

The stabilizer of claim 11, wherein the moving clamp is located in a slot in the stationary clamp to prevent rotation of the moving clamp.

### Claim 13 (depends on 11)

The stabilizer of claim 11, wherein the heart valve delivery system clamp further comprises a pin configured to prevent accidental release of the heart valve delivery system.

### Claim 14 (depends on 4)

The stabilizer of claim 4, further comprising a flange located at a proximal end of the elongated main body, the flange configured to wrap around an edge of a base.

### Claim 15 (depends on 4)

The stabilizer of claim 4, further comprising distally extending tabs configured to mate with the base adapter.

### Claim 16

A stabilizer system comprising:
a stabilizer comprising:
an elongated main body comprising a proximal end and a distal end and a longitudinal axis extending between the proximal end and the distal end, the elongated main body comprising:
a generally flat base plate extending between the proximal and the distal end;
a first angled surface located on top of the base plate, the first angled surface being sloped downwardly toward the distal end; and
a second angled surface located on top of the base plate and spaced longitudinally away from and proximal of the first angled surface, the second angled surface being sloped downwardly toward the distal end;
a hub nest attachable on top of the first angled surface, the hub nest comprising an extension extending upwards from the first angled surface, the extension configured to releasably hold a sheath hub of a heart valve delivery system, the hub nest configured to keep the sheath hub in proper position after access and prevent unwanted manipulation during a delivery procedure;
a handle carriage on top of the second angled surface, the handle carriage comprising a track attachable to the second angled surface and a heart valve delivery system clamp configured to longitudinally travel along the track, wherein the heart valve delivery system clamp is configured to releasably hold a handle of the heart valve delivery system; and
a base adapter, wherein the distal end of the main body is configured to releasably connect with the base adapter;
a base having a generally flat upper surface and a plurality of legs extending downwards;
detachable clamps to allow attachment of the main body to the base before or after starting a delivery procedure; and
a second base adapter, wherein the proximal end of the main body is configured to releasably connect with the second base adapter.

### Claim 17 (depends on 16)

The stabilizer system of claim 16, wherein the stabilizer is configured to magnetically attach to the generally flat upper surface of the base.

### Claim 18 (depends on 17)

The stabilizer system of claim 17, wherein the magnetic attachment comprises electromagnetic attachment.
