Apparatus including a core is advanceable toward a patient's heart valve. The core tapers in a distal direction toward the smallest perimeter of the core. The apparatus includes a first ventricular arm, which is articulatable with respect to a first atrial arm at a first articulation site, and a second ventricular arm, which is articulatable with respect to a second atrial arm at a second articulation site. The articulation sites are adjacent to the smallest perimeter. The tapering of the core defines a minimum nonzero angle of the atrial arms with respect to a central longitudinal axis of the core. The first atrial arm and the first ventricular arm are arranged so as to clamp the first native leaflet. The second atrial arm and the second ventricular arm are arranged so as to clamp the second native leaflet. Other embodiments are also described.

A prosthetic heart valve can include a valve frame having a wireform portion and a stent portion. The wireform and stent portions can be undetachably coupled together via a plurality of upright struts so as to form a one-piece prosthetic heart valve frame. Alternatively, a self-expanding wireform portion and a balloon-expandable stent portion can be coupled together via one or more leaflets and a subassembly having a flexible leaflet support stent and a sealing ring. The wireform portion can include cusps and commissures configured to support a plurality of leaflets. The prosthetic valve can be radially collapsible for minimally invasive and/or transcatheter delivery techniques. Disclosed embodiments can also provide flexion of the wireform portion (e.g., of the commissures) in response to physiologic pulsatile loading when the valve is implanted in a patient's native valve annulus. Methods of making and using prosthetic heart valves are also disclosed.

A packaging assembly may retain a sterile medical device for use in a surgical setting, such as an orthopedic implant or instrument. The packaging assembly may have a first packaging component and a second packaging component. The first packaging component and the second packaging component may be attachable to each other to define a first interior space containing the medical device. The first packaging component may have a first retention feature that defines a first interior receptacle shaped to receive at least part of the medical device such that a user can manually grip the medical device through the first retention feature. The first first interior space may be manually opened by a user grasping the medical device through the first retention feature.

The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

A medical device packaging system that includes a medical device packaged within an outer sleeve with an open end and a closure flap for closing an end opposite the open end. The packaging system further includes a seal that couples the closure flap to the outer sleeve to close the end opposite the open end. The seal is frangible along an edge between the closure flap and outer sleeve. The packaging system further includes an inner sleeve with a corresponding shape to the outer sleeve, and the outer sleeve and the inner sleeve are configured to move relative to each other in a longitudinal direction of the sleeves. The packaging system further includes a stiffener with a leading edge disposed within the inner and outer sleeves such that the leading edge of the stiffener is configured to interact with an inner surface of the closure flap.

A system for reshaping a valve annulus includes an elongate template having a length along a longitudinal axis and at least one concavity in a generally lateral direction along said length. The pre-shaped template is positioned against at least a region of an inner peripheral wall of the valve annulus, and at least one anchor on the template is advanced into a lateral wall of the valve annulus to reposition at least one segment of the region of the inner peripheral wall of the valve annulus into said concavity. In this way, a peripheral length of the valve annulus can be foreshortened and/or reshaped to improve coaption of the valve leaflets and/or to eliminate or decrease regurgitation of a valve.

A system for repairing a defective heart valve. The system includes a delivery device, a balloon and a prosthetic heart valve. The delivery device includes an inner shaft assembly and a delivery sheath assembly. The delivery sheath assembly provides a capsule terminating at a distal end. The prosthesis includes a stent carrying a prosthetic valve. In a delivery state, the capsule maintains the prosthesis in a collapsed condition over the inner shaft assembly, and the balloon is in a deflated arrangement radially between the prosthetic heart valve and the capsule. In a deployment state, at least a portion of the balloon and at least a portion of the prosthetic heart valve are distal the capsule. Further, the balloon is inflated and surrounds an exterior of at least a portion of the prosthetic heart valve. The balloon controls self-expansion of the prosthetic heart valve.

Implantable first atrial and ventricular arms are articulatable at a first articulation site to clamp a first heart valve leaflet. A first implantable elongate transitioning member is (a) connected at a fixed connection point at a portion of the first ventricular arm farthest from the first articulation site, (b) has a portion that faces an opposite surface of the first ventricular arm, and (c) is controllable to move the first ventricular arm. Implantable second atrial and ventricular arms are articulatable at a second articulation site to clamp a second leaflet. A second implantable elongate transitioning member is (a) connected at a fixed connection point at a portion of the second ventricular arm farthest from the second articulation site, (b) has a portion that faces an opposite surface of the second ventricular arm, and (c) is controllable to move the second ventricular arm. Other embodiments are also described.

A breast implant insertion device and method includes a shell having an open and a chamber with an implant arranged in the chamber and a flexible sheath removably connected with the shell. A lubricant is inserted into the shell to coat the implant which is then transferred to the sheath. The sheath is separated from the shell. An opening is formed in a distal end of the sheath and the sheath is squeezed to eject the implant from the sheath for insertion into a patient without any contact of the implant.

A covered stent for implantation at vascular branches includes a stent body and a membrane fixedly connected to the stent body, wherein micropore areas are provided on the membrane, and the micropore areas have a plurality of micropores which are arranged into an array with pore spacing ranging from 0.2 mm to 2.0 mm. The micropores are capable of allowing blood flow to pass through, and during implantation of the covered stent, the micropore areas are used to identify branch regions of blood vessels and provide an access path for implantation of branch stents, such that the blood flow of nearby branch vessels will not be blocked while treating aortic lesions.