Transcatheter heart valve prosthesis assembled inside heart chambers or blood vessels
Inventors
Iyer, Ramji • Anderson, Stephen • Johnson, Samuel Thomas
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11337801-B2
Publication Date
2022-05-24
Expiration Date
Abstract
Some embodiments described herein include a heart valve replacement system that may be delivered to the targeted heart valve site via a delivery catheter. In some embodiments, the heart valve replacement system can assemble a valve device after the valve device is delivered to the heart. In some embodiments, heart valve replacement system includes two anterior flaps that are separate but overlap each other.
Core Innovation
The invention relates to a transcatheter heart valve system for tricuspid replacement and includes a prosthetic tricuspid valve with a deployed configuration. The prosthetic tricuspid valve comprises a main body having valve leaflets arranged to allow flow through the main body from an inlet end to an outlet end, and is delivered using a delivery catheter in a non-tubular/helical configuration with two matable/open ends, then assembled in vivo into a tubular prosthesis.
In the deployed configuration, the prosthetic tricuspid valve further includes a first anterior flap and a second anterior flap that extend laterally from the outlet end of the main body in a same direction. The first anterior flap comprises one or more cells formed integrally with the framework of the main body, and the first and second anterior flaps overlap each other while the prosthetic tricuspid valve is in the deployed configuration.
An optional posterior flap extends laterally from the outlet end of the main body in an opposite direction to the anterior flaps, and the described deployment sequence includes releasing the posterior flap first and then placing the anterior flaps in the right ventricular outflow tract (RVOT), followed by release of the main body. The disclosure describes anchoring/sealing against non-circular native tricuspid openings and reports radiographic evidence that the prosthesis does not restrict the right coronary artery (RCA).
Claims Coverage
The provided independent claim defines a prosthetic tricuspid valve in a deployed configuration. Across the dependent claims referenced, the coverage adds anatomical placement and interaction features for the anterior flaps in the right ventricular outflow tract and native tricuspid valve opening, and optionally adds a posterior flap with directional and angular constraints.
Overlapping anterior flaps formed integrally with a main body framework
A prosthetic tricuspid valve having a deployed configuration including a main body with an occluder having valve leaflets arranged to allow flow through the main body from an inlet end to an outlet end, a first anterior flap and a second anterior flap formed integrally with the framework of the main body and extending laterally from the outlet end in a same direction, wherein portions of the first and second anterior flaps overlap each other while the prosthetic tricuspid valve is in the deployed configuration.
First anterior flap width exceeding two or more cells
A prosthetic tricuspid valve wherein the first anterior flap has a width that is greater than two or more cells of the multiple cells.
Anterior flaps extending into the right ventricular outflow tract
A prosthetic tricuspid valve configured such that the first and second anterior flaps extend into a right ventricular outflow tract when the valve is implanted in a native tricuspid valve.
First anterior flap contacting a wall of the right ventricle
A prosthetic tricuspid valve having an anterior flap configured to contact a wall of a right ventricle when implanted in a native tricuspid valve.
Anterior flaps occluding a portion of a native tricuspid valve opening
A prosthetic tricuspid valve configured so that the first and second anterior flaps occlude a portion of a native tricuspid valve opening.
Posterior flap extending laterally in an opposite direction
A prosthetic tricuspid valve further including a posterior flap extending laterally from the outlet end of the main body in an opposite direction to the first and second anterior flaps.
Posterior flap distal tip axis at a non-zero angle constraint
A prosthetic tricuspid valve configured so that a distal tip portion of the posterior flap extends along an axis at a non-zero angle relative to a portion of the posterior flap extending directly from the main body.
Overall, the claim set coverage centers on a deployed prosthetic tricuspid valve whose main body supports an occluder with valve leaflets, together with integrally formed anterior flaps that overlap and have a defined cell-width relationship. Dependent coverage further specifies placement and interaction of the anterior flaps relative to the right ventricular outflow tract and a native tricuspid valve opening, and optionally adds a posterior flap with opposite lateral direction and a non-zero distal-tip axis constraint.
Stated Advantages
Increasing bending resistance/rigidity.
Enabling low-profile collapsed delivery.
Allowing pacemaker lead pass-through between flaps.
Anchoring/sealing against non-circular native tricuspid openings.
Not restricting the right coronary artery (RCA), as supported by radiographic evidence.
Documented Applications
Transcatheter heart valve system for tricuspid replacement, including prosthetic tricuspid valve implantation in a native tricuspid valve and associated radiographic assessment regarding right coronary artery (RCA) restriction.
Interested in licensing this patent?