Prosthetic valves and related inventions
Inventors
Vidlund, Robert • Schankereli, Kemal • Lozonschi, Lucian • Lutter, Georg
Assignees
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Publication Number
US-12121434-B2
Publication Date
2024-10-22
Expiration Date
Abstract
This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.
Core Innovation
The invention relates to compressible transcatheter prosthetic heart valves that are deployable in a beating heart without extracorporeal circulation. It focuses on multi-layer tissue or synthetic valve covers configured for biocompatibility and hemocompatibility. The prosthetic heart valve includes a leaflet assembly supported by an expandable tubular stent.
A flexible gasket or sealing cuff is coupled to a ventricular end of the stent and positioned around an exterior of the stent. During deployment, the gasket is allowed to self-expand and contacts a native annulus, creating a seal and functioning to stop further travel of the prosthetic heart valve through the native valve. The gasket is associated with atrial terminus geometry and applies lateral annular compressive force to immobilize the prosthetic heart valve.
The invention further describes anchoring and retention concepts including a shuttlecock/cork V-shape gasket structure and an annular valve concept, with tethers and tether-based compliance and anchoring. Anchoring mechanisms include a spring anchor circumnavigating chordae tendineae and retention structures such as annular clamps with interdigitating hinged finger structures. Stent designs are described as flexible self-expanding or collapsible, including laser-cut and braided configurations, with predetermined conformation intended to avoid commissural regurgitation and central jet regurgitation.
Claims Coverage
Independent inventive coverage is provided by three independent claims, each directed to catheter delivery of a prosthetic heart valve and deployment of a flexible gasket against the native tricuspid valve annulus. The claims share core deployment and stop-travel functionality, with additional features specifying self-expansion and immobilization forces, atrial terminus geometry, or wedge behavior into the native annulus.
Gasket deployment to stop prosthetic travel through native tricuspid valve
Advancing a delivery catheter into or adjacent a native tricuspid valve while the prosthetic heart valve is in a collapsed condition, beginning to deploy a flexible gasket from the delivery catheter, and advancing the prosthetic heart valve through the native tricuspid valve until the deployed gasket contacts an annulus of the native tricuspid valve to stop the prosthetic heart valve from traveling further, wherein the gasket is coupled to the stent at a joint at or near the ventricular end of the stent.
Self-expanding gasket applying lateral annular compressive force to immobilize
Advancing a delivery catheter into or adjacent a native tricuspid valve with a prosthetic heart valve in a collapsed condition, beginning to deploy the flexible gasket, and advancing the prosthetic heart valve through the native tricuspid valve until the gasket contacts an annulus to stop further travel, wherein beginning to deploy includes allowing the gasket to self-expand and after advancing the gasket provides a lateral annular compressive force against the native tricuspid valve annulus to immobilize the prosthetic heart valve, wherein the gasket has an atrial terminus with a diameter larger than a diameter of the ventricular end of the stent.
Advancing causes gasket to wedge into native tricuspid valve annulus
Advancing a delivery catheter into or adjacent a native tricuspid valve with a prosthetic heart valve in a collapsed condition, beginning to deploy a flexible gasket, and advancing the prosthetic heart valve through the native tricuspid valve until the gasket contacts an annulus to stop further travel, wherein advancing the prosthetic heart valve through the native tricuspid valve causes the deployed gasket to wedge into the native tricuspid valve annulus.
Across the independent claims, the core inventive approach is catheter-based deployment of a prosthetic heart valve having a stent-supported leaflet assembly and a flexible gasket coupled to the ventricular end of the stent, where the gasket contacts the native tricuspid annulus to stop further valve travel. Claim-specific variations include self-expansion with lateral annular compressive force to immobilize and a functional requirement that advancing causes the gasket to wedge into the native annulus.
Stated Advantages
To stop the prosthetic heart valve from traveling further through the native tricuspid valve by contact between the deployed gasket and the native tricuspid valve annulus.
To immobilize the prosthetic heart valve by applying lateral annular compressive force against the native tricuspid valve annulus.
To wedge the deployed gasket into the native tricuspid valve annulus when advancing the prosthetic heart valve through the native tricuspid valve.
Documented Applications
Treating tricuspid valve regurgitation in a patient using a delivery catheter and a catheter-delivered prosthetic heart valve with a deployed flexible gasket contacting the native tricuspid valve annulus.
Deploying a compressible transcatheter prosthetic heart valve in a beating heart without extracorporeal circulation.
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