US-12616570-B2 - Three-dimensional thin-film leaflet valve device

US12616570B2US 12616570 B2US12616570 B2US 12616570B2US-12616570-B2

Abstract

Examples of the disclosure are directed toward a valve device comprising an opening and a leaflet and methods of operating and manufacturing the valve device. In some embodiments, the leaflet is a three-dimensional thin-film leaflet, and the leaflet comprises a dome portion. In a first configuration, the leaflet of the valve device may occlude the opening of the device. In a second configuration, the leaflet may not occlude the opening, and blood may flow across the opening of the device. The valve device may be collapsible for transportation in a catheter.

Inventors

Daniel Corey ANDERSON
Lowie Michel Roger VAN ASSCHE
Hussain Soaeb RANGWALA
Christopher S. MALAISRIE

Assignees

NININGER MEDICAL, INC.

Dates

Publication Date: 20260505
Application Date: 20210401

Claims (17)

1 . A valve device, comprising: an opening, a leaflet comprising: a downstream surface to trap blood pumped by a heart muscle, and an upstream surface to selectively occlude the opening when the leaflet's downstream surfaces trap blood pumped by the heart muscle, wherein the upstream surface comprises a dome portion, wherein: the leaflet is a three-dimensional thin-film leaflet, a shape of the leaflet includes a plurality of profiles, each profile includes dimensions of an interfacing surface height, an outer cylindrical surface height, and a profile slope angle, and the profile slope angle is associated with geometries of the dome portion, and a frame defining the opening and comprising anchoring prongs, wherein: the leaflet is attached to the frame, and when the frame is in a partially deployed configuration, the anchoring prongs are at an angle between 15 and 60 degrees relative to an axis from the downstream surface to the upstream surface.
2 . The device of claim 1 , wherein the interfacing surface height is 2-10 mm, the outer cylindrical surface height is 3-25 mm, and the profile slope angle is −45 to 45 degrees.
3 . The device of claim 1 , further comprising a second leaflet, wherein the leaflets' upstream surfaces collectively occlude the opening when the leaflets are in a first configuration, and the upstream surfaces do not collectively occlude the opening when the leaflets are in a second configuration.
4 . The device of claim 3 , wherein each leaflet comprises an interfacing surface that, while the leaflets occlude the opening, contacts an adjacent leaflet's interfacing surface.
5 . The device of claim 1 , wherein the leaflet has a thickness of 5-25 μm.
6 . The device of claim 1 , wherein the device comprises a collapsed configuration such that the device in the collapsed configuration is deliverable in a catheter having a cross sectional diameter of 5-15 mm.
7 . The device of claim 1 , wherein the leaflet comprises: a first configuration in response to a force from the downstream side to the upstream side, and a second configuration in response to a force from the upstream side to the downstream side.
8 . The device of claim 7 , wherein the force from the downstream side to the upstream side includes a force generated by an increase of the blood being trapped.
9 . The device of claim 7 , wherein the leaflet collapses in response to the force from the upstream side to the downstream side.
10 . The device of claim 1 , wherein the leaflet returns toward an inflated shape in response to an increase of the blood being trapped.
11 . The device of claim 1 , wherein: the anchoring prongs maintain the device at a native valve location, and the anchoring prongs are in a pinching position upon contact with an underside of native leaflets.
12 . The device of claim 1 , further comprising a cord connecting the anchoring prongs, the cord configured to tighten and pull the anchoring prongs toward the frame as the frame expands from a collapsed configuration such that the anchoring prongs are in a pinching position upon contact with an underside of native leaflets.
13 . A method of operating an artificial valve comprising: deploying the artificial valve; in response to blood pumped by a heart muscle in a direction from a downstream surface to an upstream surface of a thin-film leaflet of the artificial valve: selectively occluding an opening of the artificial valve with the upstream surface, wherein the upstream surface comprises a dome portion, and trapping the blood pumped by the heart muscle with the downstream surface; and in response to blood flow in a direction from the upstream surface to the downstream surface: deforming, with a force of the blood flow, the leaflet, and allowing the blood flow across the opening, wherein: the leaflet is a three-dimensional thin-film leaflet, a shape of the leaflet includes a plurality of profiles, each profile includes dimensions of an interfacing surface height, an outer cylindrical surface height, and a profile slope angle, and the profile slope angle is associated with geometries of the dome portion, and deploying the artificial valve comprises configuring a frame of the artificial valve to a partially deployed configuration, wherein when the frame is in the partially deployed configuration, anchoring prongs of the frame are at an angle between 15 and 60 degrees relative to an axis from the downstream surface to the upstream surface.
14 . The method of claim 13 , wherein deploying the artificial valve further comprises tightening a cord of the artificial valve connecting the anchoring prongs to pull the anchoring prongs toward the frame as the frame expands from a collapsed configuration such that the anchoring prongs are in a pinching position upon contact with an underside of native leaflets.
15 . A method of manufacturing a valve device comprising: fabricating a three-dimensional thin-film leaflet via vacuum deposition, PVD, CVD, or any combination thereof, wherein the thin-film leaflet comprises: a downstream surface, and an upstream surface, wherein the upstream surface comprises a dome portion, wherein: a shape of the leaflet includes a plurality of profiles, each profile includes dimensions of an interfacing surface height, an outer cylindrical surface height, and a profile slope angle, and the profile slope angle is associated with geometries of the dome portion; providing a plurality of cells; forming a frame by coupling the plurality of cells, wherein the frame defines an opening of the valve device; and attaching the leaflet to the frame.
16 . The method of claim 15 , further comprising shaping the leaflet via the vacuum deposition, the PVD, the CVD, or any combination thereof.
17 . The method of claim 15 , wherein one of more the cells comprise anchoring prongs, the method further comprising providing a cord connecting the anchoring prongs.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a national stage application under 35 U.S.C. § 371 of International Application No. PCT/US2021/025441, filed internationally on Apr. 1, 2021, which claims benefit of U.S. Provisional Application No. 63/003,840 filed Apr. 1, 2020, the entire disclosures of which are herein incorporated by reference for all purposes. FIELD OF THE INVENTION This disclosure generally relates to medical devices. More specifically, this disclosure relates to artificial valves. BACKGROUND OF THE INVENTION More than 1.6 million patients in the United States may need treatment for moderate to severe tricuspid regurgitation (TR). The presence of moderate to severe TR may be associated with poor prognosis, with as many as 36% of patients dying within one year. However, given the high mortality and morbidity of surgical tricuspid valve repair or replacement, only 8,000 surgeries are performed. Therefore, there is currently an unmet need for the treatment of these patients. For example, known transcatheter tricuspid valves cannot be reliably compressed and delivered to the anatomic location. Design limitations exist in both the valve leaflets and the valve frame supporting the leaflets. Further, these known designs are expensive to manufacture and prone to failure when deployed. For at least these reasons, a more reliable, a more cost-effective, and a more durable valve device is sought. SUMMARY OF THE INVENTION Examples of the disclosure are directed toward a valve device comprising an opening and a leaflet and methods of operating and manufacturing the valve device. In some embodiments, the leaflet is a three-dimensional thin-film leaflet, and the leaflet comprises a dome portion. In a first configuration, the leaflet of the valve device may occlude the opening of the device. In a second configuration, the leaflet may not occlude the opening, and blood may flow across the opening of the device. The valve device may be collapsible for transportation in a catheter. In some embodiments, a valve device, comprises: an opening, and a leaflet comprising: a downstream surface to trap blood pumped by a heart muscle, and an upstream surface to selectively occlude the opening when the leaflet's downstream surfaces trap blood pumped by the heart muscle. In some embodiments, the leaflet is a three-dimensional thin-film leaflet. In some embodiments, the upstream surface comprises a dome portion. In some embodiments, a shape of the leaflet includes a plurality of profiles, each profile includes dimensions of an interfacing surface height, an outer cylindrical surface height, and a profile slope angle, and the profile slope angle is associated with geometries of the dome portion. In some embodiments, the interfacing surface height is 2-10 mm, the outer cylindrical surface height is 3-25 mm, and the profile slope angle is −45 to 45 degrees. In some embodiments, the shape of the leaflet includes a dimension of an average slope associated with an average of at least some of the profile slope angles along at least a part of a depth of the leaflet, and the average slope is 0 to 45 degrees. In some embodiments, the device consists three leaflets. In some embodiments, the device further comprises a second leaflet, wherein the leaflets' upstream surfaces collectively occlude the opening when the leaflets are in a first configuration, and the upstream surfaces do not collectively occlude the opening when the leaflets are in a second configuration. In some embodiments, each leaflet comprises an interfacing surface that, while the leaflets occlude the opening, contacts an adjacent leaflet's interfacing surface. In some embodiments, the interfacing surface has a height of 2-10 mm. In some embodiments, the interfacing surface comprises ridges and troughs. In some embodiments, the ridges and troughs are parallel to a direction from the upstream surface to the downstream surface. In some embodiments, the interfacing surface comprises dimples located periodically along the interfacing surface. In some embodiments, the interfacing surface comprises cuts. In some embodiments, a thickness along a surface of the leaflet is non-uniformed. In some embodiments, the device further comprises a frame, wherein a portion of the leaflet attaches to the frame, the portion comprising a non-uniform thickness. In some embodiments, the leaflet has a thickness of 5-250 μm. In some embodiments, the device comprises a collapsed configuration such that the device in the collapsed configuration is deliverable in a catheter having a cross sectional diameter of 5-15 mm. In some embodiments, the leaflet comprises at least one of biocompatible alloy, polymer, and composite structure. In some embodiments, the leaflet is fabricated using vacuum deposition, physical vapor deposition (PVD), or chemical vapor deposition (CVD). In some embodiments, the leaflet comprises: a first configuration in response to a force from the downstream side