# US 11,998,447 B2 · Retrievable prosthesis delivery system

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- Number: US 11,998,447 B2
- Document ID: US11998447B2
- Status: Granted
- Kind: B2
- Application number: 16/811,693
- Filed: 2020-03-06
- Published: 2020-09-10
- Granted: 2024-06-04
- Earliest claimed: 2019-03-08
- Assignees: Neovasc Tiara Inc.
- Applicants: Neovasc Tiara Inc.
- Inventors: Keith Alan Jackson; Karen Tsoek-Ji Wong; Christopher Brodeur; Eric Soun-Sang Fung; Kellen Bodell; Fredericus Antonius Colen; Shmuel Banai; Juzer Banatwala
- Web page: https://patentgrep.com/patent/US11998447B2

## CPC

- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/9517: {handle assemblies therefor}
- A61F 2/2439: {Expansion controlled by filaments}
- A61F 2210/0019: operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/0034: D-shaped
- A61F 2230/005: Rosette-shaped, e.g. star-shaped
- A61F 2230/0054: V-shaped
- A61F 2250/0039: differing in diameter
- A61M 25/0136: {Handles therefor}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- 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)
- 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

A prosthetic delivery system may include a plurality of concentric shafts and an actuator mechanism for actuating one or more of the concentric shafts. A stop mechanism may be coupled to the actuator mechanism. The stop mechanism prevents advancement or retraction of at least some of the shafts beyond a predetermined position unless the stop mechanism is released. A second stop mechanism may be included in the system for controlling another of the shafts. A plurality of filaments may be coupled to a prosthesis carried by the delivery system and actuation of the filaments may be used to control deployment or retrieval of the prosthesis.

## Claims

### Claim 1

A method for delivering a prosthesis, said method comprising:
providing a prosthesis carried on a delivery catheter within a capsule, the delivery catheter comprising:
an anchor catheter connected to the prosthesis;
a guidewire catheter extending concentrically with the anchor catheter to connect to the capsule; and
a steerable catheter at least partially surrounding the anchor catheter and the guidewire catheter;
at least partially deploying the prosthesis from the capsule by actuating the guidewire catheter to cause translation between the capsule and the prosthesis; and
retrieving the prosthesis back into the capsule of the delivery catheter by actuating a plurality of filaments coupled to the prosthesis;
wherein the capsule comprises proximal and distal sections that can be axially translated away from each other to deploy the prosthesis, and the proximal and distal sections of the capsule have an outer profile size that is larger than the delivery catheter.

### Claim 2 (depends on 1)

The method of claim 1, further comprising steering the delivery catheter by actuating a tether coupled to the delivery catheter.

### Claim 3 (depends on 1)

The method of claim 1, further comprising adjusting tension on a plurality of stylets connected to the plurality of filaments to control deployment of the prosthesis from the delivery catheter.

### Claim 4 (depends on 1)

The method of claim 1, wherein retrieving the prosthesis back into the capsule of the delivery catheter by actuating a plurality of filaments coupled to the prosthesis comprises operating a tension equalizer to simultaneously control tension on each of the plurality of filaments.

### Claim 5 (depends on 1)

The method of claim 1, wherein at least partially deploying the prosthesis from the capsule comprises fully deploying elbows of ventricular anchors extending from the prosthesis such that the elbows expand radially outward of the capsule by moving the capsule distally with the guidewire catheter.

### Claim 6 (depends on 5)

The method of claim 5, wherein retrieving the prosthesis back into the capsule of the delivery catheter by actuating the plurality of filaments coupled to the prosthesis comprises pulling the elbows radially inward of the capsule by pulling the plurality of filaments proximally, wherein proximal pulling of the plurality of filaments produces radial movement of the elbows that is discrete from axial movement of the prosthesis.

### Claim 7 (depends on 5)

The method of claim 5, wherein the plurality of filaments are attached to the elbows via a single tether extending through loops of each filament and the elbows.

### Claim 8 (depends on 1)

The method of claim 1, further comprising releasing the plurality of filaments to allow full deployment of the prosthesis.

### Claim 9 (depends on 8)

The method of claim 8, wherein releasing the plurality of filaments comprises releasing tension in the plurality of filaments such that opening of the prosthesis via spring action pulls the plurality of filaments from the prosthesis.

### Claim 10 (depends on 8)

The method of claim 8, wherein all of the plurality of filaments are connected in a single loop and releasing the plurality of filaments comprises pulling the single loop from the prosthesis.

### Claim 11 (depends on 8)

The method of claim 8, wherein:
the delivery catheter comprises a handle located at a proximal end of the steerable catheter; and
the capsule is located distally of the steerable catheter and axially translatable relative to the steerable catheter.

### Claim 12 (depends on 8)

The method of claim 8, wherein releasing the plurality of filaments comprises:
moving an anchor plate connected to the prosthesis away from a plurality of slanted tabs around which each of the plurality of filaments is attached, the plurality of slanted tabs extending from an anchor element attached to the delivery catheter, wherein each of the plurality of filaments is trapped between one of the plurality of slanted tabs and the anchor plate;
expanding the prosthesis via spring action to pull the plurality of filaments along the plurality of slanted tabs; and
allowing each of the plurality of filaments to slip off a slanted tab of the plurality of slanted tabs at a gap between the plurality of slanted tabs and the anchor plate due to the spring action.

### Claim 13 (depends on 12)

The method of claim 12, wherein pushing the anchor plate connected to the prosthesis away from each of the slanted tabs to release the plurality of filaments comprises actively pushing the anchor plate with a push rod.

### Claim 14 (depends on 12)

The method of claim 12, wherein pushing the anchor plate connected to the prosthesis away from each of the slanted tabs to release the plurality of filaments comprises passively pushing the anchor plate with a spring.

### Claim 15 (depends on 1)

The method of claim 1, wherein the capsule comprises a rigid body defining an enclosure having an internal space in which the prosthesis is disposed separated from an internal space of the steerable catheter.

### Claim 16

A method for delivering a mitral valve prosthesis, said method comprising:
partially deploying the mitral valve prosthesis while being carried on a delivery catheter by sliding a sheath away from the mitral valve prosthesis to progressively expose an anchor portion of the mitral valve prosthesis;
deploying from the sheath elbows of ventricular anchors extending from the anchor portion of the mitral valve prosthesis by allowing the elbows to radially expand beyond the anchor portion and the sheath independent of axial movement of the anchor portion; and
applying tension to a plurality of filaments attached to the elbows to collapse the elbows radially inward toward the anchor portion independent of axial movement of the anchor portion and then sliding the sheath toward the mitral valve prosthesis to retrieve the mitral valve prosthesis back into the sheath, wherein the plurality of filaments are attached to the elbows via a single tether extending through loops of each filament and the elbows.

### Claim 17 (depends on 16)

The method of claim 16, further comprising:
fully deploying the mitral valve prosthesis from the catheter;
releasing tension on the plurality of filaments; and
detaching the delivery catheter form the mitral valve prosthesis.

### Claim 18 (depends on 17)

The method of claim 17, further comprising allowing the mitral valve prosthesis to spring open to detach the plurality of filaments from the mitral valve prosthesis, wherein the elbows comprise inferior portions of the ventricular anchors adjacent to connection points of the ventricular anchors with a ventricular skirt extending from the anchor portion, and wherein the ventricular anchors are configured to spring radially outward of the anchor portion of the mitral valve prosthesis when deployed.

### Claim 19 (depends on 17)

The method of claim 17, further comprising operating an anchor device to allow the plurality of filaments to detach from the mitral valve prosthesis.

### Claim 20 (depends on 17)

The method of claim 17, wherein releasing tension on the plurality of filaments comprises:
moving an anchor plate away from a plurality of slanted tabs around which each of the plurality of filaments is attached, the plurality of slanted tabs extending from an anchor element attached to the delivery catheter, wherein each of the plurality of filaments is trapped between one of the plurality of slanted tabs and the anchor plate;
expanding the mitral valve prosthesis via spring action to pull the plurality of filaments along the plurality of slanted tabs; and
allowing each of the plurality of filaments to slip off a slanted tab of the plurality of slanted tabs at a gap between the plurality of slanted tabs and the anchor plate due to the spring action.

### Claim 21 (depends on 16)

The method of claim 16, wherein applying tension to a plurality of filaments attached to the elbows comprises pulling the elbows radially toward a longitudinal axis of the delivery catheter with radially extending portions the plurality of filaments.

### Claim 22 (depends on 16)

The method of claim 16, wherein applying tension to a plurality of filaments attached to the elbows comprises operating an equalizer device to apply tension to each of the plurality of filaments simultaneously.
