# US 12,109,111 B2 · Transseptal delivery system

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- Number: US 12,109,111 B2
- Document ID: US12109111B2
- Status: Granted
- Kind: B2
- Application number: 16/812,865
- Filed: 2020-03-09
- Published: 2020-07-02
- Granted: 2024-10-08
- Earliest claimed: 2015-12-15
- Assignees: Neovasc Tiara Inc.
- Applicants: Neovasc Tiara Inc.
- Inventors: Colin A. Nyuli; Randy Matthew Lane; Karen Tsoek-Ji Wong
- Web page: https://patentgrep.com/patent/US12109111B2

## CPC

- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/0133: {Tip steering devices}
- A61M 25/09: Guide wires
- A61F 2/9517: {handle assemblies therefor}
- A61F 2/97: the outer sleeve being splittable
- 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 delivery system includes a delivery catheter with a capsule configured to carry a prosthesis and a steering catheter for steering the delivery catheter. The delivery catheter can be advanced through a patient's vasculature to a target treatment area. The capsule can be opened and the prosthesis can be deployed into the target treatment area. Additionally, a method for delivering a prosthesis to a target treatment area includes advancing a delivery catheter through a patient's vasculature to the target treatment area, steering the delivery catheter toward the target treatment area, opening a capsule on the delivery catheter, and deploying the prosthesis into the target treatment area.

## Claims

### Claim 1

A delivery system for delivering a prosthesis to a target treatment area, the system comprising:
an inner guidewire catheter having a proximal end, a distal end, and a lumen extending therebetween, the lumen sized to slidably receive a guidewire;
a distal capsule coupled to the distal end of the inner guidewire catheter, wherein the distal capsule comprises an inner channel sized to receive the prosthesis;
a bell catheter slidably disposed over the inner guidewire catheter, the bell catheter having a bell element adjacent a distal end of the bell catheter;
an anchor catheter slidably disposed over the bell catheter, the anchor catheter having an anchor element adjacent a distal end of the anchor catheter and configured to engage the prosthesis, and wherein the bell element constrains the prosthesis into engagement with the anchor element;
a sheath catheter slidably disposed over the anchor catheter, the sheath catheter having a proximal end and a distal end; and
an actuator mechanism comprising a first rotational actuator element, wherein the first rotational actuator element is operably coupled to both the inner guidewire catheter and the bell catheter, wherein actuation of the first rotational actuator element in a first direction moves the distal capsule proximally, and wherein actuation of the first rotational actuator element in a second direction opposite the first direction moves the distal capsule distally and moves the bell element away from the anchor element thereby removing a constraint from the prosthesis and allowing the prosthesis to expand.

### Claim 2 (depends on 1)

The system of claim 1, further comprising a steerable catheter having an actuator mechanism comprising a rotatable knob, wherein the inner guidewire catheter, the bell catheter, the anchor catheter, and the sheath catheter are slidably disposed in the steerable catheter, and wherein actuation of the rotatable knob steers the steerable catheter, thereby steering the inner guidewire catheter, the bell catheter, the anchor catheter, and the sheath catheter.

### Claim 3 (depends on 1)

The system of claim 1, further comprising a handle coupled to a proximal portion of the delivery system, the actuator mechanism coupled to the handle.

### Claim 4 (depends on 1)

The system of claim 1, wherein the distal capsule comprises an expandable member.

### Claim 5 (depends on 4)

The system of claim 4, wherein the expandable member comprises a stent or a balloon.

### Claim 6 (depends on 1)

The system of claim 1, wherein the distal capsule comprises an accordion region.

### Claim 7 (depends on 1)

The system of claim 1, wherein the distal capsule comprises a plurality of hinged splines configured to radially expand at the hinge when compression is applied to the plurality of hinged splines.

### Claim 8 (depends on 1)

The system of claim 1, further comprising the prosthesis, and wherein the prosthesis is a prosthetic mitral valve.

### Claim 9

A method for delivering a prosthesis to a target treatment area, the method comprising:
providing a delivery system having a distal capsule coupled to an inner guidewire catheter, a bell catheter having a bell element disposed adjacent a distal end of the bell catheter, an anchor catheter having an anchor element adjacent a distal end of the anchor catheter, and a sheath catheter disposed over the bell catheter, the guidewire catheter and the anchor catheter,
actuating an actuation mechanism comprising a first rotational actuator element, wherein the actuating comprises actuating the first rotational actuator element in a first direction thereby moving the distal capsule proximally, and wherein the actuating further comprises actuating the first rotational actuator element in a second direction opposite the first direction thereby moving the distal capsule distally and moving the bell element away from the anchor element;
releasing the prosthesis disposed in the distal capsule; and
deploying the prosthesis in the target treatment area.

### Claim 10 (depends on 9)

The method of claim 9, wherein the inner guidewire catheter is slidably disposed in the sheath catheter, and wherein actuating the first rotational actuator element moves the inner guidewire catheter relative to the sheath catheter.

### Claim 11 (depends on 10)

The method of claim 10, wherein the target treatment area is a native mitral valve.

### Claim 12 (depends on 10)

The method of claim 10, wherein the prosthesis is a prosthetic mitral valve.

### Claim 13 (depends on 9)

The method of claim 9, further comprising steering the delivery system with a steerable catheter disposed over the delivery system.

### Claim 14 (depends on 9)

The method of claim 9, wherein the distal capsule comprises an expandable member.

### Claim 15 (depends on 14)

The method of claim 14, wherein the expandable member comprises a stent or a balloon.

### Claim 16 (depends on 9)

The method of claim 9, wherein the distal capsule comprises an accordion region.

### Claim 17 (depends on 9)

The method of claim 9, wherein the distal capsule comprises a plurality of hinged splines.