Device and method with reduced pacemaker rate in heart valve replacement

Inventors

Schreck, Stefan • Rangwala, Hussain S. • SAFFARI, Payam

Assignees

Jenavalve Technology Inc

Abstract

The disclosure relates to heart valve 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 disclosure describes a heart valve prosthesis for implantation at a native valve site that includes a ring of cells disposed at a proximal end and a stent at a distal end. The stent comprises interconnected cells that define stent arches, and the interconnected cells extend from the stent arches to the ring of cells. A stent cover coupled to the stent covers at least a portion of the stent and comprises a prosthetic valve, while separate locator covers completely cover ends of respective locators and are configured to contact native leaflets.

The prosthesis includes a plurality of locators that are coupled to stent arches and configured to extend radially with respect to the stent to capture at least a portion of a respective native leaflet between each locator and the stent. 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 prosthesis and the native valve site, while permitting blood flow to at least one coronary artery at the native valve site.

The disclosure further constrains the distal stent architecture to manage coronary artery blood flow by coupling stent arches and spacing apexes a certain distance apart so that the coupled stent arches permit blood flow to at least one coronary artery. In some configurations, the locators extend radially when the stent is in a compressed state, and locator and stent geometry is arranged such that at least one coronary artery receives unobstructed blood flow. The prosthesis also includes imaging or visualization features via deformable indicator means, including deforming contact indicators, to enable fluoroscopic detectability of correct implantation and the location of the prosthesis relative to native cusp tissue.

Claims Coverage

The provided claims include two independent claims, each centered on a native-valve-site heart valve prosthesis that combines a sealing stent cover with radially extending leaflet-capture locators and separate locator covers, while preserving blood flow to at least one coronary artery. Across the independent claims, there are three main inventive feature areas: the sealing prosthesis architecture, leaflet capture by radially extending locators, and coronary-perfusion permitting stent-arch apex spacing and coupling.

Together, the independent claims require a native-site valve prosthesis architecture in which a sealing stent and a stent cover with a prosthetic valve prevent blood flow between the prosthesis and the native valve site, while radially extending locators and separate locator covers capture native leaflets and maintain coronary artery blood flow. The coronary-perfusion function is further tied to coupled stent-arch geometry with apex spacing.

Stated Advantages

Documented Applications