Prosthetic valves and related inventions

Inventors

Vidlund, RobertSchankereli, KemalLozonschi, LucianLutter, Georg

Assignees

Tendyne Holdings Inc

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Publication Number

US-12059343-B2

Patent

Publication Date

2024-08-13

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 provides a transcatheter prosthetic heart valve system for replacing a native mitral valve using a compressible expandable tubular stent and an expandable internal leaflet assembly supported by the stent. The prosthetic heart valve is delivered in a collapsed condition to a left atrium and then deployed to interact with the native mitral valve annulus. A flexible gasket is coupled to a ventricular end of the stent and positioned around an exterior of the stent.

A sealing and stopper configuration is formed by deploying the gasket from the delivery catheter while the delivery catheter is in the left atrium. After deployment, the prosthetic heart valve is advanced through the native mitral valve until the deployed gasket contacts the annulus of the native mitral valve to stop further travel. The gasket is capable of being compressed to create lateral pressure in the native mitral valve annulus and to hold the prosthetic heart valve in place.

The invention further addresses obstruction avoidance by requiring that, upon replacing the native mitral valve, the prosthetic heart valve sits in the native mitral valve annulus at an angle directed away from a native aortic valve so that the prosthetic does not obstruct flow through the native aortic valve. The system includes a flexible gasket coupled at or near the ventricular end of the stent, enabling a controlled stopping and positioning interaction with the mitral annulus.

Claims Coverage

The partial content includes three independent claims, each sharing a common delivery-to-left-atrial-deploy-and-advance-with-a-gasket framework and differing by additional holding and positioning requirements.

Collapsed prosthetic heart valve delivery to left atrium with stent, leaflet assembly, and ventricular end gasket

Advancing a delivery catheter to a left atrium of a patient, the delivery catheter containing the prosthetic heart valve in a collapsed condition during the advancing, the prosthetic heart valve including a stent, a leaflet assembly supported by the stent, and a flexible gasket coupled to a ventricular end of the stent and positioned around an exterior of the stent.

Deploy gasket from left atrium and stop further travel by annulus contact

While the delivery catheter is in the left atrium of the patient, deploying the gasket from the delivery catheter; and after deploying the gasket from the delivery catheter, advancing the prosthetic heart valve through the native mitral valve until the deployed gasket contacts an annulus of the native mitral valve to stop the prosthetic heart valve from traveling further through the native mitral valve.

Gasket coupled at or near the ventricular end of the stent

The gasket is coupled to the stent at a joint at or near the ventricular end of the stent.

Entire prosthetic valve held by lateral pressure from compressed gasket in mitral annulus

Upon advancing the prosthetic heart valve through the native mitral valve, the entire prosthetic valve is held by lateral pressure caused by forcible compression of the gasket in the native mitral valve annulus.

Prosthetic heart valve angled away from native aortic valve to avoid obstruction

Upon replacing the native mitral valve with the prosthetic heart valve, the prosthetic heart valve sits in the native mitral valve annulus at an angle directed away from a native aortic valve of the patient so that the prosthetic heart valve does not obstruct flow through the native aortic valve.

Across the independent claims, the core claim coverage centers on delivering a collapsed prosthetic heart valve to the left atrium, deploying a flexible gasket coupled to the ventricular end of a stent, advancing the valve through the native mitral valve until the gasket contacts the mitral annulus to stop further travel, and implementing additional features for holding by lateral pressure and positioning at an angle away from the native aortic valve to prevent obstruction of aortic flow.

Stated Advantages

Stops the prosthetic heart valve from traveling further through the native mitral valve.

Holds the prosthetic valve in place by lateral pressure caused by forcible compression of the gasket in the native mitral valve annulus.

Does not obstruct flow through the native aortic valve by positioning the prosthetic at an angle directed away from the native aortic valve.

Documented Applications

Replacing a native mitral valve with a prosthetic heart valve using transcatheter delivery to a left atrium and deployment of a gasket from the delivery catheter.

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