# US 11,992,403 B2 · Devices, systems and methods for improving recapture of prosthetic heart valve device with stent frame having valve support with inwardly stent cells

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- Number: US 11,992,403 B2
- Document ID: US11992403B2
- Status: Granted
- Kind: B2
- Application number: 17/111,736
- Filed: 2020-12-04
- Published: 2021-09-09
- Granted: 2024-05-28
- Earliest claimed: 2020-03-06
- Assignees: 4C Medical Technologies, Inc.
- Applicants: 4C Medical Technologies, Inc.
- Inventors: Jonathan Berndt; Sounthara Khouengboua; Saravana Kumar
- Web page: https://patentgrep.com/patent/US11992403B2

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/95: Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2439: {Expansion controlled by filaments}
- A61F 2002/9511: {the retaining means being filaments or wires}
- A61F 2002/9528: {for retrieval of stents}
- A61F 2230/0071: spherical
- 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

A collapsible and expandable prosthetic mitral valve stent is provided with improved recapture into a distal lumen of a delivery sheath. Various embodiments comprise a valve support within the interior of a stent frame and defining a flow channel therethrough, wherein the top or upstream of the valve support comprises a row, or a plurality, of stent cells that are bent radially inward at least partially over the flow channel. Some embodiments may comprise a recapture assist mechanism, such as an open paddle, attached to one or more of the inwardly bent stent cells and adapted to receive and/or engage a wire to aid in positioning, expansion, recapture and/or implanting the device in a patient's heart chamber.

## Claims

### Claim 1

A prosthetic heart valve device, adapted for expansion and implantation into a heart chamber of a patient for supplementation and/or replacement of native valve leaflet functionality, the device comprising:
a collapsible and expandable stent having an outer section comprising an outer surface, an inner surface, and defining an interior;
a valve support operationally connected to the collapsible and expandable stent, wherein the valve support extends radially upward into the interior of the outer section and comprises an inflow end and an outflow end, wherein a blood flow channel is defined between the inflow end and the outflow end, and wherein the valve support is inverted entirely within the interior of the outer section; and
a plurality of prosthetic valve leaflets disposed within the blood flow channel defined by the valve support, wherein the prosthetic valve leaflets are configured to allow flow from the inflow end to the outflow end of the flow channel and prevent flow from the outflow end of the flow channel to the inflow end of the flow channel;
wherein:
the inflow end of the valve support comprises a plurality of top-most stent cells that are bent radially inwardly over the blood flow channel;
the valve support comprises a plurality of stent cells that are not the top-most stent cells; and
at least one of the plurality of stent cells that are not the top-most stent cells further comprises at least one recapture assist mechanism disposed thereon.

### Claim 2 (depends on 1)

The device of claim 1, wherein the valve support is defined and formed by the collapsible and expandable stent.

### Claim 3 (depends on 1)

The device of claim 1, further comprising transition cells that turn the outer section of the collapsible and expandable stent radially inward, the transition cells being disposed between the outer section of the collapsible and expandable stent and the valve support.

### Claim 4 (depends on 2)

The device of claim 2, further comprising transition cells that turn the outer section of the collapsible and expandable stent radially inward, the transition cells disposed between the outer section of the collapsible and expandable stent and the valve support.

### Claim 5 (depends on 1)

The device of claim 1, wherein the valve support and the outer section of the valve support comprise a single unitary stent.

### Claim 6 (depends on 1)

The device of claim 1, wherein the at least one recapture assist mechanism is configured to engage a wire to assist in one or more of the group consisting of: directional positioning during delivery of the device; recapture of the device during delivery; and resheathing of the device during delivery.

### Claim 7 (depends on 6)

The device of claim 6, wherein the wire comprises a push and/or pull wire.

### Claim 8 (depends on 7)

The device of claim 7, wherein the recapture assist mechanism comprises an open paddle adapted to engage the wire.

### Claim 9 (depends on 7)

The device of claim 7, wherein the recapture assist mechanism comprises a slot adapted to engage the wire.

### Claim 10 (depends on 1)

A method for delivery, recapturing and/or positioning the prosthetic heart valve device of claim 1 into a heart chamber of a patient, the method comprising:
providing:
a delivery catheter having a lumen therethrough;
the at least one recapture assist mechanism; and
at least one push and/or pull wire comprising a distal end that is operatively engaged with the at least one recapture assist mechanism;
placing the delivery catheter within the patient such that a distal end of the delivery catheter and lumen are within the heart chamber and a proximal end of the delivery catheter and lumen are outside the patient's body;
collapsing and loading the prosthetic heart valve device into a proximal end of the delivery catheter lumen and translating the prosthetic heart valve device distally;
delivering the prosthetic heart valve device from the distal end of the delivery catheter lumen at least partially into the heart chamber;
at least partially expanding the prosthetic heart valve device within the heart chamber; and
implanting the prosthetic heart valve device within the heart chamber.

### Claim 11 (depends on 10)

The method of claim 10, further comprising manipulating at least one of the at least one push and/or pull wires to modify a position of at least the valve support during expansion, positioning, recapturing and/or implanting of the prosthetic heart valve device.

### Claim 12 (depends on 10)

The method of claim 10, wherein the heart chamber is the left atrium.

### Claim 13 (depends on 10)

The method of claim 10, wherein the prosthetic heart valve device, when implanted, is adapted to supplement the native mitral valve leaflet functionality.

### Claim 14 (depends on 10)

The method of claim 10, wherein the prosthetic heart valve device, when implanted, is adapted to supplement and eventually replace the native mitral valve leaflet functionality.

### Claim 15 (depends on 10)

The method of claim 10, wherein the delivery catheter is placed within the patient using a transseptal delivery access route.

### Claim 16 (depends on 10)

The method of claim 10, wherein the delivery catheter is placed within the patient using one of the access routes in the group consisting of: transapical; transfemoral; and transatrial.

### Claim 17 (depends on 10)

The method of claim 10, wherein the prosthetic heart valve device, when implanted, is adapted to replace the native mitral valve leaflet functionality.