Abstract: The disclosure relates to transcatheter stented prosthesis delivery devices including a handle assembly connected to a shaft assembly on which a stented prosthesis is loaded and compressively retained with a plurality of elongate tension members. The delivery devices include a cutting assembly that can sever the elongate tension members after the stented prosthesis is expanded at a target site so that the delivery device can be withdrawn from the patient. Certain embodiments position the cutting assembly at least within the shaft assembly and others position the cutting assembly over the shaft assembly. Various disclosed cutting assemblies are actuated with the handle assembly or the like, which draw the tension members across the blade or vice versa.

Abstract: The invention features modular implantable ventricular assist devices configured to be, at least in part, assembled within a patient. The devices generally include a pump assembly and an expandable frame. The frame is configured to engage tissue of a patient when implanted. The pump assembly is configured to be operably coupled to the frame when the frame is implanted and in the expanded configuration.

Abstract: A “dry” packaging in which a prosthetic heart valve is packaged within a container with hydrogel that can be provided in many forms. Certain embodiments include hydrogel that is preloaded with glycerol or the like. The hydrogel regulates the humidity within the container through a diffusion-driven mechanism if a gradient of humidity between the inside and the outside of the hydrogel exists. Humidity regulation is important to prevent the tissue of the valve structure from drying out. When the partially-hydrated hydrogel is present within container, which is saturated with air of a predefined humidity, the water molecules from the air will be absorbed by the hydrogel if the air humidity is high (i.e. when the thermodynamics favor hydrogel hydration) or vice versa. Various embodiments are configured to also house at least a portion of a delivery device for delivering the prosthetic heart valve.

Abstract: Aspects of the disclosure relate to “wet” transcatheter prosthetic heart valve or other implant packaging and assemblies in which a prosthetic heart valve or other implant is loaded into a first portion of a delivery device and positioned within a container in which sterilizing fluid is retained to sterilize interior portions of the container as well as provide moisture to prevent the implant from drying out. The disclosure also relates to methods of sterilizing the disclosed assemblies. Some disclosed methods include at least two sterilizing steps and adjustment of a mechanical seal member or formation of multiple seals so that areas proximate the seals are also sterilized during the sterilization process.

Abstract: Embodiments hereof relate to methods of delivering a valve prosthesis to an annulus of a native valve of a heart, the native valve having chordae tendineae. A chordae management catheter is positioned within a ventricle of the heart, the chordae management catheter having a displacement component at a distal end thereof. The displacement component has an annular shape and defines a central lumen therethrough. The displacement component is radially expanded to push chordae tendineae within the ventricle radially outward. A valve delivery system is introduced into the ventricle of the heart via a ventricular wall of the heart. The valve delivery system has the valve prosthesis at a distal portion thereof. The valve delivery system is advanced through the central lumen of the radially expanded displacement component towards the annulus of the native valve of the heart. The valve prosthesis is deployed into apposition with the annulus of the native valve.

Abstract: Disclosed herein is a nickel-titanium alloy comprising nickel, titanium, and at least one rare earth element. The nickel-titanium alloy comprises from about 34 at. % to about 60 at. % nickel, from about 34 at. % to about 60 at. % titanium, and from about 0.1 at. % to about 15 at. % at least one rare earth element. The nickel-titanium alloy may further include one or more additional alloying elements. In addition to radiopacity, the nickel-titanium alloy preferably exhibits superelastic or shape memory behavior. Medical devices comprising the nickel-titanium alloy and a method of making them are also disclosed.

Abstract: The invention features modular implantable ventricular assist devices configured to be, at least in part, assembled within a patient. The devices generally include a pump assembly and an expandable frame. The frame is configured to engage tissue of a patient when implanted. The pump assembly is configured to be operably coupled to the frame when the frame is implanted and in the expanded configuration.

Abstract: The invention features modular implantable ventricular assist devices configured to be, at least in part, assembled within a patient. The devices generally include a pump assembly and an expandable frame. The frame is configured to engage tissue of a patient when implanted. The pump assembly is configured to be operably coupled to the frame when the frame is implanted and in the expanded configuration.

Abstract: Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.

Abstract: The invention features modular implantable ventricular assist devices configured to be, at least in part, assembled within a patient. The devices generally include a pump assembly and an expandable frame. The frame is configured to engage tissue of a patient when implanted. The pump assembly is configured to be operably coupled to the frame when the frame is implanted and in the expanded configuration.

Abstract: Disclosed herein is a nickel-titanium alloy comprising nickel, titanium, and at least one rare earth element. The nickel-titanium alloy comprises from about 34 at. % to about 60 at. % nickel, from about 34 at. % to about 60 at. % titanium, and from about 0.1 at. % to about 15 at. % at least one rare earth element. The nickel-titanium alloy may further include one or more additional alloying elements. In addition to radiopacity, the nickel-titanium alloy preferably exhibits superelastic or shape memory behavior. Medical devices comprising the nickel-titanium alloy and a method of making them are also disclosed.

Abstract: Disclosed herein is a nickel-titanium alloy comprising nickel, titanium, and at least one rare earth element. The nickel-titanium alloy comprises from about 34 at. % to about 60 at. % nickel, from about 34 at. % to about 60 at. % titanium, and from about 0.1 at. % to about 15 at. % at least one rare earth element. The nickel-titanium alloy may further include one or more additional alloying elements. In addition to radiopacity, the nickel-titanium alloy preferably exhibits superelastic or shape memory behavior. Medical devices comprising the nickel-titanium alloy and a method of making them are also disclosed.

Abstract: A dual lumen catheter may be provided with one or more stents in a stent-deployment lumen and a wire guide disposed through a wire guide lumen. The wire guide may be directed to a target site in a patient body such as a biliary stricture. The catheter may be directed along the wire guide until it is in or adjacent the target site. A distalmost stent may be advanced out a distal side-facing aperture of the stent-deployment lumen into the target site by a pusher member that advances the stent or that holds the stent in place while the catheter is proximally withdrawn from around the stent. With the wire guide remaining substantially in place, the stent-deployment lumen can be reoriented and the steps repeated to place a second (and, if desired, subsequent) stent(s) next to—and generally parallel with—the first stent.

Abstract: Embodiments include a fiducial deployment system. A fiducial may include dimples to enhance echogenicity and/or to provide for engagement with a delivery cannula or stylet. The needle system may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time, when the fiducials are coaxially disposed around a central deployment member that may be embodied as a delivery cannula or stylet. In certain embodiments, echogenic placement of fiducials may present certain advantages. An elongate structure may be included that is configured to distally advance fiducials along the deployment member.

Abstract: Embodiments include a fiducial deployment system. A fiducial may include dimples to enhance echogenicity and/or to provide for engagement with a delivery cannula or stylet. The needle system may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time, when the fiducials are coaxially disposed around a central deployment member that may be embodied as a delivery cannula or stylet. In certain embodiments, echogenic placement of fiducials may present certain advantages. An elongate structure may be included that is configured to distally advance fiducials along the deployment member.

Abstract: A dual lumen catheter may be provided with one or more stents in a stent-deployment lumen and a wire guide disposed through a wire guide lumen. The wire guide may be directed to a target site in a patient body such as a biliary stricture. The catheter may be directed along the wire guide until it is in or adjacent the target site. A distalmost stent may be advanced out a distal side-facing aperture of the stent-deployment lumen into the target site by a pusher member that advances the stent or that holds the stent in place while the catheter is proximally withdrawn from around the stent. With the wire guide remaining substantially in place, the stent-deployment lumen can be reoriented and the steps repeated to place a second (and, if desired, subsequent) stent(s) next to—and generally parallel with—the first stent.

Abstract: Embodiments include a fiducial deployment system. A fiducial may include dimples to enhance echogenicity and/or to provide for engagement with a delivery cannula or stylet. The needle system may be configured to deliver a plurality of fiducials to a target location in serial fashion, one at a time, when the fiducials are coaxially disposed around a central deployment member that may be embodied as a delivery cannula or stylet. In certain embodiments, echogenic placement of fiducials may present certain advantages. An elongate structure may be included that is configured to distally advance fiducials along the deployment member.

Abstract: Disclosed herein is a nickel-titanium alloy comprising nickel, titanium, and at least one rare earth element. The nickel-titanium alloy comprises from about 34 at. % to about 60 at. % nickel, from about 34 at. % to about 60 at. % titanium, and from about 0.1 at. % to about 15 at. % at least one rare earth element. The nickel-titanium alloy may further include one or more additional alloying elements. In addition to radiopacity, the nickel-titanium alloy preferably exhibits superelastic or shape memory behavior. Medical devices comprising the nickel-titanium alloy and a method of making them are also disclosed.

Abstract: A vascular graft (30) comprises a proximal inlet section (31), a first distal section (32) and a second distal section (33). The first distal section (32) and the second distal section (33) are attached to the proximal inlet section (31) at a Y-shaped bifurcation region. In use the proximal inlet section (31) is attached to a first part (34) of a host artery in an end-to-side anastomosis. A second part (35) of the host artery is cut to form a first section (36) of the host artery on a first side of the cut and a second section (37) of the host artery on a second side of the cut. The first distal section (32) is attached to the first section (36) in an end-to-end anastomosis, and the second distal section (33) is attached to the second section (37) in an end-to-end anastomosis.

Abstract: The present invention provides a transition device assembly for transitioning between a first floor covering and a second floor covering that includes an elongated T-shaped member, a covering and an elongated base. The elongated T-shaped member has an upper portion and a base portion. The covering is attached to the elongated T-shaped member and covers a top and each side of the upper portion of the T-shaped member. The elongated base has a substantially flat portion and a longitudinally extending upwardly opening channel for receiving the base portion of the elongated T-shaped member. There may also be a notch in each end of the covering and the elongated T-shaped member to accommodate a doorstop. Alternatively, the covering also extends beyond the ends of the elongated T-shaped member and has a notch in each end of the extended covering to accommodate a doorstop.