Abstract: An introducer for providing access to the interior of the heart generally includes a valve, a shaft, and a piercing element. The valve has a substantially closed state in the absence of an instrument inside the valve and an open state in the presence of the instrument inside the valve. The shaft has first and second ends. The piercing element is located at the first end of the shaft. The shaft is removably positioned inside the valve in an assembled condition. The valve is dimensioned to receive the instrument therein upon removal of the shaft from the valve.

Abstract: A transcatheter valve delivery system includes a longitudinal member extending between a proximal end and a distal end, and having a compartment adjacent the distal end for holding a medical device in a collapsed condition. An alignment element is connected to the longitudinal member and is movable relative to the longitudinal member between a stowed position and a deployed position. In the deployed position, the alignment element is configured to urge against an anatomical surface to position the longitudinal member at a desired location relative to the anatomical surface.

Abstract: A delivery system (100) for delivering a collapsible prosthetic heart valve includes a body (120) extending in a longitudinal direction and a sheath (130) slidable relative to the body. A compartment (155) is defined inside the sheath and is adapted to receive the collapsible prosthetic heart valve in a collapsed condition. The system includes an articulating joint having a first portion operatively connected to the compartment and a second portion operatively connected to the body. The first portion is pivotable relative to the second position so as to pivot the sheath from a first orientation extending in the longitudinal direction to a second orientation extending transverse to the longitudinal direction.

Abstract: An apparatus for applying liquid pressure to resected tissue may include a fixture, a papillary assembly coupled to the fixture and having first and second spaced apart papillary attachment elements, and a resected mitral valve attached to the fixture. The fixture may have a first chamber, a second chamber, and an internal panel extending between the first and second chambers. The resected mitral valve may be attached to the internal panel and may have a posterior leaflet, an anterior leaflet, and tendinae chordae. The tendinae chordae may each be attached at a first end to the posterior leaflet or the anterior leaflet and at a second end to one of the papillary attachment elements. A first group of the tendinae chordae may be attached to the first papillary attachment element, and a second group of the tendinae chordae may be attached to the second papillary attachment element.

Abstract: A delivery device for a collapsible medical device may include a handle and a delivery assembly having a compartment for receiving the medical device. A catheter member may extend from the handle to the delivery assembly. The catheter member may have a first portion with a first compliance value and a second portion with a second compliance value different from the first compliance value. An internally threaded member may be fixedly connected to the delivery assembly. An externally threaded member may have a first portion operatively connected to the actuation member and a second portion threadedly coupled to the internally threaded member so that manipulation of the actuation member causes axial movement of the compartment relative to the catheter member.

Abstract: A device for repositioning an implant within a lumen of a subject including (a) a catheter having forward and rearward ends and a collapsible and expansible stop element mounted adjacent the forward end of the catheter, the stop element being adapted to engage a wall of the lumen when expanded and to provide one or more passages extending from a rear side of the stop element to a forward side of the stop element when the stop element is expanded and engaged with the wall of the lumen and (b) one or more snares, each snare having engagement features, the stop element and the snares being constructed and arranged so that the snares can be positioned extending through the one or more passages with their engagement features forward of the stop element.

Abstract: A prosthetic heart valve includes a stent having an expanded condition and a collapsed condition. The stent includes a plurality of distal cells, a plurality of proximal cells, a plurality of support struts coupling the proximal cells to the distal cells, and at least one support post connected to a plurality of proximal cells. The proximal cells are longitudinally spaced apart from the distal cells. Various strut configurations and connections of the struts to the proximal cells and of the proximal cells to the support post improve stent flexibility and reduce stress in the valve leaflets.

Abstract: A delivery device for a collapsible medical device may include a handle and a delivery assembly having a compartment for receiving the medical device. A catheter member may extend from the handle to the delivery assembly. The catheter member may have a first portion with a first compliance value and a second portion with a second compliance value different from the first compliance value. An internally threaded member may be fixedly connected to the delivery assembly. An externally threaded member may have a first portion operatively connected to the actuation member and a second portion threadedly coupled to the internally threaded member so that manipulation of the actuation member causes axial movement of the compartment relative to the catheter member.

Abstract: A method of preparing a tissue swatch comprising one or more desired thicknesses for use in the manufacture of a bioprosthetic device, said method comprising sectioning a sheet of frozen tissue to produce a tissue swatch of said one or more desired thicknesses.

Abstract: A prosthetic heart valve includes a stent having an expanded condition and a collapsed condition. The stent includes a plurality of distal cells, a plurality of proximal cells, a plurality of support struts coupling the proximal cells to the distal cells, and at least one support post connected to a plurality of proximal cells. The proximal cells are longitudinally spaced apart from the distal cells. Various strut configurations and connections of the struts to the proximal cells and of the proximal cells to the support post improve stent flexibility and reduce stress in the valve leaflets.

Abstract: A device for repositioning an implant within a lumen of a subject including (a) a catheter having forward and rearward ends and a collapsible and expansible stop element mounted adjacent the forward end of the catheter, the stop element being adapted to engage a wall of the lumen when expanded and to provide one or more passages extending from a rear side of the stop element to a forward side of the stop element when the stop element is expanded and engaged with the wall of the lumen and (b) one or more snares, each snare having engagement features, the stop element and the snares being constructed and arranged so that the snares can be positioned extending through the one or more passages with their engagement features forward of the stop element.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent, a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets, and a deformable frame having a first end and a second end. The frame includes braided wires forming a body having a lumen extending therethrough for receiving the stent and the valve assembly, the body having a plurality of diameters from the first end to the second end.

Abstract: An introducer provides access to a surgical site in a patient. The introducer includes a proximal housing configured to be positioned outside the patient and a sheath extending from the proximal housing to a distal end of the introducer. One or more handles may be housed at least partially within the proximal housing and configured to translate axially in proximal and distal directions with respect to the proximal housing. A securing element may be slideably coupled to the sheath and may have a flange extending radially outwardly from the sheath. A radially expanding portion of the sheath may have a first edge, a second edge, and a middle section extending from the first edge to the second edge. The sheath portion may have a rolled configuration in which the middle section at least partially overlies the first edge, and the second edge at least partially overlies the middle section.

Abstract: A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent, a collapsible and expandable valve assembly disposed within the stent and having a plurality of leaflets, and a deformable frame having a first end and a second end. The frame includes braided wires forming a body having a lumen extending therethrough for receiving the stent and the valve assembly, the body having a plurality of diameters from the first end to the second end.

Abstract: A method of preparing a tissue swatch comprising one or more desired thicknesses for use in the manufacture of a bioprosthetic device, said method comprising sectioning a sheet of frozen tissue to produce a tissue swatch of said one or more desired thicknesses.

Abstract: An introducer provides access to a surgical site in a patient. The introducer includes a proximal housing configured to be positioned outside the patient and a sheath extending from the proximal housing to a distal end of the introducer. One or more handles may be housed at least partially within the proximal housing and configured to translate axially in proximal and distal directions with respect to the proximal housing. A securing element may be slideably coupled to the sheath and may have a flange extending radially outwardly from the sheath. A radially expanding portion of the sheath may have a first edge, a second edge, and a middle section extending from the first edge to the second edge. The sheath portion may have a rolled configuration in which the middle section at least partially overlies the first edge, and the second edge at least partially overlies the middle section.

Abstract: A prosthetic heart valve includes an annular frame having annularly spaced commissure portions and an annulus portion disposed near an inflow edge, a fabric covering at least a portion of the frame and a valve assembly connected to the frame at the commissure portions, the valve assembly including a plurality of leaflets. A stiffening member is disposed about the frame to limit ovalization of the frame when a radial force is applied to the frame.

Abstract: A medical device delivery system includes an inner shaft having a proximal end and a distal end, a support shaft having a proximal end and a distal end and an articulating assembly disposed between the inner shaft and the support shaft. The support shaft is sized for insertion into the circulatory system of a patient. The articulating assembly includes a first portion extending from the distal end of the inner shaft and a second portion at the proximal end of the support shaft. The first portion is pivotable relative to the second portion to change orientation of the support shaft relative to the inner shaft. A retainer is secured to a portion of the articulating assembly and is configured to retain a medical device on the support shaft between the retainer and the distal end of the support shaft.

Abstract: An apparatus for applying liquid pressure to resected tissue may include a fixture, a papillary assembly coupled to the fixture and having first and second spaced apart papillary attachment elements, and a resected mitral valve attached to the fixture. The fixture may have a first chamber, a second chamber, and an internal panel extending between the first and second chambers. The resected mitral valve may be attached to the internal panel and may have a posterior leaflet, an anterior leaflet, and tendinae chordae. The tendinae chordae may each be attached at a first end to the posterior leaflet or the anterior leaflet and at a second end to one of the papillary attachment elements. A first group of the tendinae chordae may be attached to the first papillary attachment element, and a second group of the tendinae chordae may be attached to the second papillary attachment element.

Abstract: A device for positioning a reference element during aortic valve implantation surgery. The device includes a first extension member having a proximal end and a distal end, a connection member adapted to connect the first extension member to a support, and a coupling having a first end connected to the connection member and a second end connected to the proximal end of the first extension member so that the first extension member is moveable in multiple planes relative to the support. At least one reference datum is operatively connected to the distal end of the first extension member and extends in a straight line, the reference datum being moveable between a first position and a second position to enable precise locating of the reference datum during the aortic valve implantation surgery.