Abstract: A method of preparing a sterilized heart valve, the method comprising: compressing a compressible frame of a heart valve from an expanded configuration to a crimped configuration; the heart valve comprising the frame and a plurality of leaflets coupled to the frame; wherein each of the plurality of leaflets comprises a dry, unfixed, decellularized, antigen-free biological tissue that has been treated with a solution comprising a polyol or polyhydric alcohol; packaging the heart valve within a sealed packaging system while the heart valve is in the crimped configuration; and sterilizing the heart valve packaged within the sealed packaging system with one or more cycles of electron beam radiation.

Abstract: In one embodiment, a method of assembling a prosthetic valve can comprise forming a radially expandable and compressible frame by pivotally joining together a plurality of struts without requiring individual rivets. In some embodiments, the frame is formed by interweaving the struts, which can be joined using integral hinges formed in the struts, such as by performing alternate cuts on the struts, bending the struts to form stopper tabs adjacent to joints and/or drilling holes in the struts to facilitate interconnecting struts at joints, or otherwise forming integral hinges and corresponding holes at junction points between the struts. In other embodiments, separate hinges are provided to interconnect the struts. In still other embodiments, separate flanged rivets are provided to connect the struts.

Abstract: A prosthetic valve includes an annular frame and a skirt. The frame is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The skirt has a fold around an inflow end of the frame so as to cover at least a portion of an outer surface of the frame and at least a portion of an inner surface of the frame. When the frame is in the radially expanded configuration, an outer portion of the skirt tightly conforms to the outer surface of the frame and the inflow end of the frame is axially spaced from the fold to form an axially extending gap between the frame and the fold. When the frame is in the radially compressed configuration, the inflow end of the frame extends axially so as to at least partially fill the axially extending gap.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: A sealing member for a prosthetic heart valve includes an annular fabric body having a first circumferential portion and a second circumferential portion. The first circumferential portion extends circumferentially around the annular fabric body and is resiliently stretchable in a direction along the longitudinal axis of the annular fabric body between an expanded configuration of the prosthetic heart valve and a collapsed configuration of the prosthetic heart valve. The second circumferential portion extends around the annular fabric body and is circumferentially offset from the first circumferential portion, the second circumferential portion being resiliently stretchable in a circumferential direction between the collapsed configuration of the prosthetic heart valve and the expanded configuration of the prosthetic heart valve.

Abstract: A device for deploying a suture clip onto a suture can include a proximal handle portion that includes an actuation mechanism. The device can also include an outer shaft defining an inner lumen. A crimping assembly can be at least partially disposed within a distal end of the outer shaft. The crimping assembly can include a plurality of crimping members configured to receive and radially compress a suture clip. The actuating mechanism can be configured to move the plurality of crimping members radially inwardly from a first position, where the crimping members are configured to receive a suture clip, to a second position where the plurality of crimping members are configured to radially compress the suture clip, causing the suture clip to plastically deform and become secured around one or more sutures.

Abstract: An expandable docking station includes an annular valve seat having an end, an annular outer wall comprising struts disposed around the valve seat, and links that connect the end of the annular valve seat to the annular outer wall. Each of the links extends from the struts of the annular outer wall directly toward a longitudinal axis that runs longitudinally through a center of the docking station, and to a corresponding one of a plurality of circumferentially spaced axially extending legs at least partially defining the annular valve seat. The outer wall is configured to conform to an interior shape of a blood vessel, when expanded inside the blood vessel, such that the outer wall can expand in multiple locations to conform to multiple bulges of the blood vessel and can contract in multiple locations to conform to multiple narrowed regions of the blood vessel.

Abstract: Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a larger width than the first portion. The first portions of the first and second shell members define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portions of the first and second shell members define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus, proximal to a valve mounting portion of the distal end portion of the delivery apparatus.

Abstract: An annuloplasty repair segment for heart valve annulus repair and a method for forming. A multi-stranded cable replaces solid core wire for both the tricuspid and mitral valves which allows for greater deployment flexibility for minimally-invasive surgical (MIS) implant, while still maintaining the required strength and similar tensile properties of solid-core wire. The particular shape of the annuloplasty ring is fixed using a heat setting process including heating the flexible core member to a temperature higher than 500° C. and holding it in a desired heat-set saddle shape for a period of time. The core is then rapidly cooled to impart physical properties such that the flexible core member can be straightened, during implantation, to fit through a tubular access device and regain the heat-set saddle shape after exiting the access device and, when attached to the native heart valve, the flexible core member is strong enough to remodel the native heart valve.

Abstract: Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a valved conduit. The valved conduit may include at least one leaflet and an interior surface that mitigates against thrombus formation within the conduit.

Abstract: A semi-automatic precision positioning robot apparatus and method for use of the same to hold, position, orient and/or move a workpiece are provided. The positioning apparatus utilizes an actuator system of a given configuration to manipulate a workpiece holding unit with multiple degrees of freedom to achieve various positions and orientations. An associated took may further be provided to interact with the workpiece in various positions and orientations. The positioning apparatus enables an operator to obtain high degrees of maneuverability while maintaining precision and consistency in the manufacture and production of various products and components.

Abstract: An device for treating a native valve includes a sealing element and an anchoring element. The sealing element is made from a braided mesh material. The sealing element is dimensioned to be deployed in an annulus of a native valve of a heart at a position between native valve leaflets to contact the native valve leaflets during ventricular systole to create a seal to prevent regurgitation of blood from the left ventricle to the left atrium. The sealing element is configured to both be radially expanded and radially reduced while at the position between the native valve leaflets. The anchoring element is adapted for deployment in the heart, the anchoring element coupled to the sealing element and configured to support the sealing element at the desired position between native valve leaflets.

Abstract: Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

Abstract: Described embodiments are directed toward prosthetic valves and systems and methods of making prosthetic valves. In accordance with an embodiment, a prosthetic valve comprises and leaflet frame, and outer frame and a film. The leaflet frame has a generally tubular shape defining a plurality of leaflet windows. The outer frame has a generally tubular shape. The leaflet frame is coaxially disposed at least partially within the outer frame. The leaflet frame and outer frame is coupled at least in part by a contiguous portion of the film. At least a portion of the contiguous portion of the film is contained between and coupling the leaflet frame and outer frame operable to prevent relative movement and contact therebetween. The film defines a leaflet extending from each of the leaflet windows.

Abstract: A delivery apparatus includes a steerable guide sheath. The steerable guide sheath has a steerable portion, a pull ring located in the distal portion, and a pull wire coupled at one end to the pull ring and coupled at the opposite end to a control handle. The pull wire extends longitudinally through a pull-wire conduit. The steerable guide sheath further includes a compression-resistance portion made of metal and located in the distal portion.

Abstract: A method for improving leaflet prolapse and/or valve regurgitation associated with a heart valve involves introducing a chordae tendineae capturing device into a ventricle of a heart, the chordae tendineae capturing device comprising a central hub component and a plurality of spokes, extending the plurality of spokes outward from the central hub component, rotating the chordae tendineae capturing device in a first direction to bring at least one of the plurality of spokes into physical contact with one or more cords of chordae tendineae disposed in the ventricle, further rotating the chordae tendineae capturing device in the first direction to bring the one or more cords inward towards the central hub component, and closing the plurality of spokes at least partially over the one or more cords to secure the one or more cords.

Abstract: A contoured biological tissue for a bioprostheses, such as a cardiac/vascular patch or a bioprosthetic heart valve, and methods of contouring the tissue, are described. A predetermined pattern is provided on the tissue, comprising a plurality of ridges or depressions that are configured to facilitate cellular migration in a first direction and discourage cellular migration in a second direction. The biological tissue can be used in connection with a bioprosthetic heart valve comprising a biological tissue leaflet structure coupled to a supporting frame.

Abstract: Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon. The distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion, and a radiopaque marker is disposed on the flared portion.