# US 10,765,518 B2 · Heart valve support device and methods for making and using the same

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- Number: US 10,765,518 B2
- Document ID: US10765518B2
- Status: Granted
- Kind: B2
- Application number: 15/850,255
- Filed: 2017-12-21
- Published: 2018-06-21
- Granted: 2020-09-08
- Earliest claimed: 2016-12-21
- Assignees: TriFlo Cardiovascular Inc.
- Applicants: TriFlo Cardiovascular Inc.
- Inventors: Luca Pesce; Alfonso Ussia
- Web page: https://patentgrep.com/patent/US10765518B2

## CPC

- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2/2436: {Deployment by retracting a sheath}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0008: Fixation appliances for connecting prostheses to the body
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- 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

The disclosure relates to a device for supporting functions of a heart valve and methods for making and using the same. The device includes a flow optimizer configured to be located in the valve and having a cross sectional area that reduces a regurgitation orifice of the valve during systole. The device includes an anchoring mechanism coupled to the flow optimizer and configured to fix a position of the flow optimizer relative to the valve. The flow optimizer allows hemodynamic flow during diastole, minimizing risk of inducing atrioventricular pressure gradient and thrombogenesis, and seals or minimizes the regurgitation orifice during systole and reinstates efficacy of the valve. The anchoring system requires no traumatic interaction with the valve, atrium and ventricle. Implantation of the device can be achieved without invasive surgery. The device permits intra-procedural optimization of the positioning of the flow optimizer.

## Claims

### Claim 1

A device for assisting with functioning of a tricuspid valve of a heart, comprising:
a shaft defining a central axis of the device and including distal and proximal end regions;
a flow optimizer fixedly connected the distal end region of said shaft and configured to be located in the tricuspid valve, including:
a frame including a plurality of radially and distally extending frame arms; and
a covering attached to the plurality of frame arms and spreading between adjacent frame arms of the plurality of frame arms, the covering configured to collapse toward the central axis during diastole and to inflate at least partially toward native tricuspid valve leaflets of the tricuspid valve during systole, the covering defining a cross sectional area configured to reduce a regurgitation orifice of the tricuspid valve during systole; and
an anchoring mechanism connected to the proximal end region of said shaft, the anchoring mechanism including one or more anchoring arms extending radially away from the shaft, wherein a first of the one or more anchoring arms is configured to rotate relative to a second of the one or more anchoring arms about the central axis of the device.

### Claim 2

A device for supporting functions of a tricuspid valve of a heart, comprising:
a flow optimizer including:
a frame including a plurality of radially extending frame arms; and
a covering attached to the plurality of frame arms and spreading between adjacent frame arms of the plurality of frame arms, the covering defining a cross sectional area of the flow optimizer, the cross sectional area during systole being greater than the cross sectional area during diastole and configured to reduce a regurgitation orifice of the tricuspid valve during systole; and
an anchoring mechanism coupled to said flow optimizer and configured to fix a position of the flow optimizer relative to the tricuspid valve, the anchoring mechanism including one or more anchoring arms each including a proximal end portion and a distal end portion, the distal end portion having a curved portion configured to engage with a commissure of the native tricuspid valve leaflets.

### Claim 3 (depends on 2)

The device of claim 2, wherein the covering is configured to collapse at least partially in a direction of a hemodynamic flow during diastole.

### Claim 4 (depends on 2)

The device of claim 2, wherein the frame has a conical shape, each of the plurality of arms having a first end region joining at a central axis of the conical shape.

### Claim 5 (depends on 4)

The device of claim 4, wherein the conical shape has a base configured to be oriented towards a ventricle of the heart and a vertex configured to be oriented towards an atrium of the heart.

### Claim 6 (depends on 2)

The device of claim 2, wherein the covering includes a plurality of leaflet layers each arranged concentrically about a central axis of the device.

### Claim 7 (depends on 6)

The device of claim 6, wherein the plurality of leaflet layers include two or more leaflet layers, the two or more leaflet layers including first and second leaflet layers that at least partially overlap.

### Claim 8 (depends on 7)

The device of claim 7, wherein the first and second leaflet layers are configured to open a gap to hemodynamic flow between the first and second leaflet layers during diastole.

### Claim 9 (depends on 7)

The device of claim 7, wherein the first and second leaflet layer are respectively located proximally and distally from the central axis, an atrium-facing surface of the first leaflet layer overlaps at least partially with a ventricle-facing surface of the second leaflet layer.

### Claim 10 (depends on 2)

The device of claim 2, wherein the covering is configured to inflate at least partially toward native tricuspid valve leaflets during systole.

### Claim 11 (depends on 2)

The device of claim 2, wherein the covering is configured to at least partially block the regurgitation orifice during systole.

### Claim 12 (depends on 2)

The device of claim 2, wherein the distal end portion is configured to mate with an annulus of the tricuspid valve at the commissure.

### Claim 13 (depends on 12)

The device of claim 12, wherein each of the one or more anchoring arms is configured to have a range of shape expansion and adapts to a geometry of the annulus of the tricuspid valve at the commissure.

### Claim 14 (depends on 2)

The device of claim 2, wherein at least one of the one or more anchoring arms is configured to rotate about a central axis of the anchoring mechanism.

### Claim 15 (depends on 14)

The device of claim 14, wherein the at least one anchoring arm is configured to rotate about the central axis to match angular distribution of the commissures.

### Claim 16 (depends on 14)

The device of claim 14, wherein the one or more anchoring arms include a first anchoring arm, a proximal end portion of the first anchoring arm including a cylindrical protrusion aligned with the central axis.

### Claim 17 (depends on 14)

The device of claim 14, wherein the one or more anchoring arms include a second anchoring arm, the proximal end portion of the second anchoring arm mated with an inner core.

### Claim 18 (depends on 14)

The device of claim 14, wherein rotating the at least one anchoring arm about the central axis changes an angle between the first and second anchoring arms.

### Claim 19 (depends on 14)

The device of claim 14, wherein said anchoring mechanism includes a locking mechanism configured to fix relative positions among the one or more anchoring arms.

### Claim 20 (depends on 14)

The device of claim 14, wherein the at least one anchoring arm is configured to rotate prior to loading into a catheter, after deployment in the heart via the catheter, or a combination thereof.

### Claim 21 (depends on 2)

The device of claim 2, wherein the one or more anchoring arms include three anchoring arms, the distal end portion of each of the three anchoring arms being configured to be located at a respective commissure of the native tricuspid valve leaflets.

### Claim 22 (depends on 2)

The device of claim 2, wherein each of the one or more anchoring arms includes an intermediate portion between the proximal end portion and the distal end portion, the intermediate portion being configured to rest against an inner supra-annular wall of an atrium of the heart.

### Claim 23 (depends on 2)

The device of claim 2, wherein said anchoring mechanism includes a height adjustment mechanism configured to individually control a shape of each of the one or more anchoring arms.

### Claim 24 (depends on 2)

The device of claim 2, further comprising a shaft connecting said flow optimizer and said anchoring mechanism.

### Claim 25 (depends on 2)

The device of claim 2, wherein said anchoring mechanism includes a locking mechanism configured to fix a relative position between said flow optimizer and said anchoring mechanism.

### Claim 26 (depends on 2)

The device of claim 2, wherein each of said flow optimizer and said anchoring mechanism has a crimped conformation adapted to be loaded in a catheter and a deployed conformation upon deployment in the heart.

### Claim 27

An apparatus for implantation, comprising:
a shaft defining a central axis of the device and including distal and proximal end regions;
an anchoring mechanism including one or more anchoring arms, each anchoring arm extending radially away from a central axis of the anchoring mechanism, a distal end portion of each anchoring arm configured to be respectively located at a commissure of native tricuspid valve leaflets of a tricuspid valve of a heart;
a flow optimizer attached to the distal end region of the shaft;
wherein the anchoring mechanism is configured to slide axially and rotate about the shaft such that a relative position between the flow optimizer and the anchoring mechanism is axially and radially adjustable; and
a locking mechanism configured to lock the anchoring mechanism to the shaft so as to fix the relative axial and radial positions of the flow optimizer and the anchoring mechanism.

### Claim 28 (depends on 27)

The apparatus of claim 27, wherein the distal end portion is configured to mate with an annulus of the tricuspid valve at the commissure.

### Claim 29 (depends on 1)

The device of claim 1, wherein the first of the one or more anchoring arms is configured to rotate about the central axis to match an angular distribution of commissures of the native tricuspid valve leaflets.

### Claim 30 (depends on 1)

The device of claim 1, wherein a proximal end portion of the second anchoring arm includes a cylindrical protrusion aligned with the central axis.

### Claim 31 (depends on 1)

The device of claim 1, wherein a proximal end portion of the second anchoring arm is mated with an inner core.

### Claim 32 (depends on 1)

The device of claim 1, wherein rotating the first anchoring arm relative to the second anchoring arm changes an angle between the first and second anchoring arms.

### Claim 33 (depends on 31)

The device of claim 31, wherein the one or more anchoring arms include a third anchoring arm, the third anchoring arm configured to rotate about the central axis relative to the first and second anchoring arms.

### Claim 34 (depends on 1)

The device of claim 1, wherein said anchoring mechanism includes a locking mechanism configured to fix relative positions among the one or more anchoring arms.

### Claim 35 (depends on 1)

The device of claim 1, wherein the first anchoring arm is configured to rotate prior to loading into a catheter, after deployment in the heart via the catheter, or a combination thereof.