Device and method with reduced pacemaker rate in heart valve replacement
Inventors
Schreck, Stefan • Rangwala, Hussain S. • SAFFARI, Payam
Assignees
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Publication Number
US-12343255-B2
Publication Date
2025-07-01
Expiration Date
Abstract
The disclosure relates to heart have prostheses with the reduced need of pacemaker implantation and improved means for positioning the replacement heart valve. In one aspect of the present disclosure, the stent scaffold of the valve prosthesis includes axially extending locators. The locators may be positioned within the cusp of the native aortic valve. Placement of the locators within the cusps may prevent further proximal movement of the stent scaffold into the left ventricle. By adjusting the location of the proximal end of the locators with respect to the proximal end of the stent scaffold, infra-annular placement of the stent scaffold in the aortic annulus may be assured. In another aspect, means for visualizing the positioning of replacement heart valves at an implant site inside an individual's body is disclosed.
Core Innovation
The invention relates to a heart valve prosthesis for implantation at a native valve site, including a stent configured to transition from a non-expanded state to an expanded state at the native valve site and a prosthetic valve coupled to an inner surface of the stent. The prosthetic valve includes a stent cover coupled to the stent, and the stent cover and the stent are configured to form a seal between the heart valve prosthesis and the native valve site to prevent blood flow between the heart valve prosthesis and the native valve site. A ring of cells disposed at an inflow end of the heart valve prosthesis is included in the stent structure comprising a plurality of interconnected cells.
The prosthesis further includes a plurality of locators extending from the stent for positioning the heart valve prosthesis at the native valve site. Each locator is defined by a single elongated wire extension extending to a tip at a free end, with the tip configured to contact a cusp or respective native leaflet, and the locators are configured to deform upon contact with the cusp or respective native leaflet. In the expanded state at least a portion of a respective native leaflet is sandwiched between the locator and the stent.
Additionally, the invention specifies a change in locator geometry between states: a shortest distance from the free end of the plurality of locators to the inflow end of the heart valve prosthesis is less in the expanded state than in the non-expanded state. In the disclosed catheter-delivered embodiments, axially extending locators positioned within native aortic cusps are used to prevent proximal stent migration into the left ventricle, and an asymmetric stent/seal design avoids covering coronary arteries and mitigates bundle-of-His interference.
Claims Coverage
The document includes one independent claim. The claim contains three inventive features: an expandable stent with a sealed prosthetic valve, cusp-contacting deformable locators that sandwich native leaflets, and a state-dependent reduction in shortest locator-to-inflow-end distance.
Expandable stent with sealed prosthetic valve
A stent comprising a plurality of interconnected cells, including a ring of cells disposed at an inflow end of the heart valve prosthesis, the stent configured to transition from a non-expanded state to an expanded state at the native valve site, a prosthetic valve coupled to an inner surface of the stent, and a stent cover coupled to the stent and covering at least a portion of the stent, wherein the stent cover and the stent are configured to form a seal between the heart valve prosthesis and the native valve site to prevent blood flow between the heart valve prosthesis and the native valve site.
Cusp-contacting deformable locators that sandwich native leaflets
A plurality of locators extending from the stent for positioning the heart valve prosthesis at the native valve site, each locator defined by a single elongated wire extension extending to a tip at a free end, the tip configured to contact a cusp or respective native leaflet, and each locator configured to deform upon contact with the cusp or respective native leaflet, wherein in the expanded state at least a portion of a respective native leaflet is sandwiched between such locator and the stent.
State-dependent reduction of locator shortest distance to inflow end
A shortest distance from the free end of the plurality of locators to the inflow end of the heart valve prosthesis being less in the expanded state than a shortest distance from the free end of the plurality of locators to the inflow end of the heart valve prosthesis in the non-expanded state.
The independent claim combines an expandable stent with a sealed prosthetic valve, cusp-contacting deformable locators that sandwich native leaflets in the expanded state, and a reduction in the shortest distance from locator free ends to the inflow end when expanded versus non-expanded.
Stated Advantages
Prevents blood flow between the heart valve prosthesis and the native valve site.
Reduces pacemaker need by preventing proximal stent migration into the left ventricle.
Avoids covering coronary arteries and mitigates bundle-of-His interference.
Documented Applications
Catheter-delivered implantation of an aortic heart valve prosthesis at a native valve site, including positioning locators within native aortic cusps during deployment.
Use of the disclosed aortic heart valve prosthesis to mitigate left ventricle migration and reduce pacemaker need.
Accommodation of coronary artery blood flow in the context of the disclosed stent/seal designs.
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