The expandable sheaths disclosed herein include an elastic outer tubular layer and a multisegmented inner tubular layer that includes at least two coextruded segments having different durometers and different coefficients of friction. The inner tubular layer further includes a thick wall portion integrally connected to a thin wall portion. The thin wall portion has a lower durometer than the thick wall portion. The thick wall portion has a first and second longitudinally extending end, and the thin wall portion extends between the first and second longitudinally extending ends. The elastic outer tubular layer and the inner tubular layer are radially movable between a non-expanded state, where the elastic outer tubular layer urges the first longitudinally extending end under the second longitudinally extending end, and an expanded state, where the first and second longitudinally extending ends of the inner tubular layer expand apart with the thin wall portion extending therebetween.

Devices and methods for assisting valve function, replacing venous valves, and predicting valve treatment successes. In an exemplary embodiment of an endograft body configured for expansion within a luminal organ, the endograft body comprises (a) a first portion having a proximal end defining a proximal end aperture and a distal end defining a distal end aperture, the first portion configured to increase a velocity of fluid flowing therethrough, (b) a second portion having a second portion proximal end defining a second portion proximal end aperture and a second portion distal end defining a second portion distal end aperture, wherein the distal end of the first portion is adjacent to the second portion proximal end, and (c) a valve portion positioned at or near the second portion proximal end, the valve portion configured to receive the fluid flowing through the distal end aperture of the first portion.

Apparatus and methods are described herein for use in the delivery and deployment of a prosthetic mitral valve into a heart. In some embodiments, an apparatus includes a catheter assembly, a valve holding tube and a handle assembly. The valve holding tube is releasably couplable to a proximal end portion of the catheter assembly and to a distal end portion of the handle assembly. The handle assembly includes a housing and a delivery rod. The delivery rod is configured to be actuated to move distally relative to the housing to move a prosthetic heart valve disposed within the valve holding tube out of the valve holding tube and distally within a lumen of the elongate sheath of the catheter assembly. The catheter assembly is configured to be actuated to move proximally relative to the housing such that the prosthetic valve is disposed outside of the lumen of the elongate sheath.

A method and device for perforating an aortic valve to remove excessive calcium deposits on aortic valve leaflets improves the implantation of TAVI replacement valves in patients. By removing excessive calcium deposits, the radial pressure exerted by implanted TAVI replacement valves is reduced, such that there is less blood leakage around the valve and less stress on the cardiac conductive system. A device with a collapsible punch is inserted into the aortic valve. The punch is separable such that the aortic valve leaflets are positioned between at least two elements of the punch. The two elements then compress together with the leaflets between them, causing the aortic valve to be perforated. A circumferential ring of the remaining aortic valve and calcium deposits are left to provide stability for the TAVI replacement valve.

A catheter device for transvascular delivery of a medical device to a cardiac valve region of a patient comprises an elongate sheath with a first lumen, a distal end for positioning at a heart valve, a second lumen that extends parallel to or in the sheath, and an expandable embolic protection filter. The filter is arranged to extend from an orifice of the second lumen and, in the expanded, covers ostia of the side branch vessels in the aortic arch.

A delivery apparatus includes a steerable shaft having a pull-wire conduit. A pull wire extends through the pull-wire conduit. The steerable shaft includes one or more layers. A compression-resistance portion is incorporated into at least one of the one or more layers. A cross-section of the compression-resistance portion has an arcuate shape that extends along a portion of a cross-section of the steerable shaft. The compression-resistance portion has a hardness that is greater than a hardness of the one or more layers that the compression-resistance portion is incorporated into.

Artificial heart valves, their manufacture, and methods of use are described. Generally, artificial heart valves can be deployed to replace or supplement defective heart valves in a patient. These artificial heart valves can comprise a frame with an inner skirt and leaflets. These inner skirt and leaflets can be generated from regenerative tissue to allow integration of the tissue with the body of a patient, while the frame can be generated from bioabsorbable material to allow dissolution of the frame over time. This combination of materials may allow for the artificial valve to grow with a patient and avoid costly and potentially dangerous replacement for patients receiving artificial valves.

Devices and methods are configured to allow transcarotid or subclavian access via the common carotid artery to the native aortic valve, and implantation of a prosthetic aortic valve into the heart. The devices and methods also provide for embolic protection during such an endovascular aortic valve implantation procedure.

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.

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. A number of Cartesian guide elements cooperate with the jaws to distribute forces within the crimping mechanism. The guide elements are located between the crimping jaws and an outer housing and are constrained by the outer housing for movement along lines that are tangential to a circle centered on the crimping axis. The guide elements engage at least some of the crimping jaws while the rest are in meshing engagement so as to move in synch. An actuation mechanism includes a lead screw, carriage assembly and a linkage to rotate the cam wheel with significant torque.