CARDIOVALVE LTD.

A method includes delivering an implant to a heart of a patient using a delivery tool that includes a nosepiece that is fixed to a shaft and distal to an implant, and an expandable element proximal to the nosepiece. Maximally-expanded, the expandable element (i) has an expanded external diameter at its widest part that is smaller than the expanded internal diameter of a lumen of the frame of the implant and (ii) tapers proximally away from the widest part and from the nosepiece. In a compressed state of the implant a portion of the expandable element is disposed within the lumen of the frame. The method includes, following implantation of the implant, withdrawing the expandable element proximally through the lumen of the implant, between leaflets of the implant, and out of the lumen. Other applications are also described.

A prosthetic heart valve includes a first frame shaped having metal segments and defines a lumen therethrough. A leaflet frame is coupled to and disposed within the lumen of the first frame. A second frame is configured to be placed against an upstream surface of the native valve. A plurality of prosthetic leaflets are coupled to the leaflet frame and facilitate upstream-to-downstream bloodflow through the prosthetic valve. Fabric couples the first and second frames together in the collapsed and expanded states of the prosthetic valve. In the expanded state of the prosthetic valve, the fabric separates a downstream end of the second frame and an upstream end of the metal segments of the first frame in a manner in which a gap is defined between the first and second frames, with no metallic structure being disposed within the gap. Other embodiments are also described.

An expandable prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an expandable valve body having an atrial end, a ventricular end opposite the atrial end, and an intermediate portion extending between the atrial end and the ventricular end. The valve body may include a plurality of struts intersecting at junctions. The prosthetic valve may also include a plurality of tissue anchoring legs extending from junctions within the intermediate portion of the valve body. At least one of the tissue anchoring legs may have a cross-sectional area which is larger by at least 20% than a cross-sectional area of a strut extending between the at least one tissue anchoring leg and an adjacent tissue anchoring leg.

First and second atrial arms and first and second ventricular arms are advanced to the heart. The first ventricular arm is moved distally by applying a pulling force to the first ventricular arm at a first fixed connection point that is at a portion of the first ventricular arm that is farthest from a first articulation site of the first atrial arm and the first ventricular arm, and the second ventricular arm is moved distally by applying a pulling force to the second ventricular arm at a second fixed connection point that is at a portion of the second ventricular arm that is farthest from a second articulation site of the second atrial arm and the second ventricular arm. Subsequently, the first native leaflet is clamped between the first arms, and the second native leaflet is clamped between the second arms. Other embodiments are also described.

An expandable prosthetic valve for implantation within a heart valve includes an expandable valve body having upstream and downstream ends and an intermediate portion. The valve body includes an outer frame including a plurality of outer frame struts intersecting at junctions of the outer frame struts, and an inner frame situated at least partially within the outer frame and comprising a plurality of inner frame struts intersecting at junctions of the inner frame struts. The prosthetic valve includes a plurality of tissue anchoring legs. Each leg extends from a junction of the outer frame struts that is within the intermediate portion of the valve body. A connector pin is at an intersection of one of the tissue anchoring legs and two outer frame struts that are adjacent to the tissue anchoring leg, and connects the inner and outer frames. Other embodiments are also described.

Apparatus is provided for use at a calcified native valve of a patient's heart, the apparatus including a prosthetic valve ( 22, 62, or 66 ) deliverable to the heart through a catheter. The prosthetic valve includes a frame ( 24 ) that includes: (i) a valve body ( 26 ) that circumscribes a central longitudinal axis of the prosthetic valve and defines a lumen along the axis; and (ii) arms ( 28 ) that are attached to and extend from respective circumferential sites of the valve body in an upstream direction. Each of the arms extends radially outward to a respective arm-tip ( 29 ) in an expanded state of the frame. Prosthetic leaflets ( 55 ) are disposed within the lumen and facilitate one-way fluid flow through the lumen following implantation of the prosthetic valve in the heart. A shape-conforming element ( 40 ) surrounds the valve body and conforms to calcified areas of cardiac tissue. Other embodiments are also described.

A percutaneous delivery tool includes a shaft, and proximal and distal capsules which move axially with respect to the shaft. A prosthetic valve includes a tubular portion, an upstream support portion extending therefrom and a plurality of flanges each having a respective flange end-portion. The prosthetic valve is restrainable by the delivery tool, such that the shaft and a downstream end of the tubular portion are disposed within the distal capsule, and the upstream support portion and the flange end-portions are disposed within the proximal capsule. Other embodiments are also described.

An implant for implantation at a native atrioventricular valve of a subject, includes a frame assembly, including a valve frame and an outer frame coupled to each other. The valve frame includes a tubular portion that circumscribes a longitudinal axis of the valve frame so as to define a lumen along the axis, and an upstream support portion including a plurality of arms. Each arm extends radially outward from the tubular portion to engage tissue in the atrium. The outer frame includes a ring that circumscribes the tubular portion, and a plurality of ventricular anchors that extend radially outward from the ring and are configured to anchor the implant to tissue of the ventricle. In an expanded state of the frame assembly, the implant defines a toroidal space between the plurality of ventricular anchors and the upstream support portion. Other embodiments are also described.

A valve frame includes a tubular portion defining a plurality of valve-frame coupling elements disposed circumferentially around a longitudinal axis of the valve frame, and a plurality of arms, extending radially outward from an upstream portion of the tubular portion to define an arm span, and configured to engage tissue in the atrium. An outer frame is coupled to the valve frame, and includes a ring circumscribing the tubular portion, and a plurality of flanges that extend radially outward from the ring to define a flange span, and are configured to engage ventricular tissue. Each arm defines a rigid portion and a flexible portion that is disposed radially outward from the rigid portion, and is more flexible than the rigid portion. The majority of the flexible portion is disposed further radially outward than the flange span. Other embodiments are also described.

First and second atrial arms and first and second ventricular arms are advanced to the heart. The first ventricular arm is moved distally by applying a pulling force to the first ventricular arm at a first fixed connection point that is at a portion of the first ventricular arm that is farthest from a first articulation site of the first atrial arm and the first ventricular arm, and the second ventricular arm is moved distally by applying a pulling force to the second ventricular arm at a second fixed connection point that is at a portion of the second ventricular arm that is farthest from a second articulation site of the second atrial arm and the second ventricular arm. Subsequently, the first native leaflet is clamped between the first arms, and the second native leaflet is clamped between the second arms. Other embodiments are also described.