The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Apparatus for progressively dilating the lumen of a narrow natural vessel such as an iliac artery and implanting a tubular device enabling access through the dilated lumen to conduct subsequent procedures via the dilated lumen, includes an inflatable integrated balloon locatable at least partially within the tubular device, the tubular device having a length L1 providing a self-expanding tubular body having at least a portion including stents, so that when the integrated balloon is removed the dilated lumen of the natural vessel remains dilated and supported by the tubular device.

A prosthetic heart valve for replacement of a native heart valve having a native valve annulus includes a stent body having a proximal end adjacent an inflow end and a distal end adjacent an outflow end and including an annulus section, the stent body having a radially collapsed condition and a radially expanded condition, one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction from the inflow end to the outflow end but to substantially block flow in a retrograde direction from the outflow end to the inflow end, a cuff coupled to the stent body, the cuff having a mobile portion that is moveable relative to the stent body, and at least one engagement element remote from the stent body.

Expandable devices are disclosed herein. Several of the embodiments are directed towards an expandable device comprising a stent configured to be expanded within a body conduit of a human patient. The stent may comprise a tubular sidewall having first portions and second portions. Radial expansion of the stent may cause the first portions to bow outwardly and out of radial alignment with the second portions.

Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. A valve frame can have a tapered profile when mounted on a delivery shaft, with an inflow end portion having a smaller diameter than an outflow end portion. The valve can comprise generally V-shaped leaflets, reducing material within the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. A diagonally woven inner skirt can elongate axially with the frame. Side tabs of adjacent leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be depressed radially inward relative to surrounding frame portions when the valve is crimped onto a delivery shaft.

A prosthetic heart valve is designed to be circumferentially collapsible for less invasive delivery into the patient. At the implant site the valve re-expands to a larger circumferential size, i.e., the size that it has for operation as a replacement for one of the patient's native heart valves. The valve includes structures that, at the implant site, extend radially outwardly to engage tissue structures above and below the native heart valve annulus. These radially outwardly extending structures clamp the native tissue between them and thereby help to anchor the prosthetic valve at the desired location in the patient.

Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.

Inflatable heart valve implants and methods utilizing those valves designed to reduce or eliminate the regurgitant jet associated with an incompetent atrioventricular valve. The heart valve implants, which are deployed via a transcatheter venous approach, comprise an inflatable balloon portion movably connected to an anchored guide shaft and movable from a distal position in the ventricle to a more proximal position between leaflets of a native atrioventricular valve. The range of movement of the inflatable valve body can be adjusted in situ after or before the guide shaft has been anchored to native heart tissue during surgery.

A side-deliverable prosthetic heart valve includes a valve frame defining an aperture that extends along a central axis and a flow control component mounted within the aperture and configured to permit selective blood flow therethrough. The prosthetic heart valve has a compressed configuration for side-delivery to a heart of a patient via a delivery catheter. The prosthetic heart valve is configured to transition to an expanded configuration when released from the delivery catheter for seating in a native annulus. The valve frame includes distal, proximal, and septal anchoring elements, each of which is insertable through the native annulus prior to seating the prosthetic heart valve therein. The septal anchoring element is configured to extend below the annulus and contact ventricular septal tissue to stabilize the prosthetic heart valve in the annulus when the prosthetic heart valve is seated in the annulus.

Disclosed herein is a method of crimping a prosthetic heart valve using a compact crimping mechanism. The crimping mechanism includes a plurality of jaws configured for coordinated inward movement toward a crimping axis to reduce the size of a crimping iris around a stented valve. A rotating cam wheel acts on the jaws and displaces them inward. An actuation mechanism includes a lead screw, carriage assembly and a linkage to rotate the cam wheel with significant torque.