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.

Abstract: An apparatus for simulation of an anatomical structure may include a left ventricle component having an inlet port configured to receive fluid flow therethrough, an aortic arch component having an outlet port configured to receive fluid flow therethrough, an aortic annulus component attached to and disposed between the left ventricle component and the aortic arch component, and an introducer configured to receive an elongated catheter assembly therethrough. The aortic annulus component may have an inner surface including simulated stenotic nodules. The introducer may be in fluid communication with at least one of the left ventricle component and the aortic arch component.

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 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 at 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.

Abstract: An apparatus for simulation of an anatomical structure may include a left ventricle component having an inlet port configured to receive fluid flow therethrough, an aortic arch component having an outlet port configured to receive fluid flow therethrough, an aortic annulus component attached to and disposed between the left ventricle component and the aortic arch component, and an introducer configured to receive an elongated catheter assembly therethrough. The aortic annulus component may have an inner surface including simulated stenotic nodules. The introducer may be in fluid communication with at least one of the left ventricle component and the aortic arch component.

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 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 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 (10) for a collapsible prosthetic heart valve may include an operating handle (20, 220, 320) having a housing (30, 230, 330) and a carriage selectively (40) fixed or movable relative to the housing, and a catheter assembly (16, 116, 216, 416). The catheter assembly may have an inner shaft (26, 126, 226, 326, 426) around which a compartment (23) is defined, an outer shaft (22) surrounding at least a portion of the inner shaft, a distal sheath (24) fixedly connected to the outer shaft, and a mechanism configured to apply a distal force to the outer shaft while the carriage (40) is fixed relative to the housing (30, 230, 330) to stretch the outer shaft from a compressed length to an extended length. The extended length may be greater than the compressed length along an axis of elongation of the outer shaft (22).

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: Retainer structures (150) maintain stented valves (800) on the balloon (130) of a balloon catheter during delivery of the valve to an implantation node and subsequent expansion of the valve. The retainer structures define a raised edge relative to the outer surface of the balloon and limit movement of the valve longitudinally relative to the balloon. Deflation of the balloon following expansion of the valve stent releases the valve.

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: 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 device is provided for collapsing a stented bioprosthetic valve, including first section and second sections, each spanning between first and second ends of the device. The second section of the device is associated with the first section to at least partially enclose an internal cavity formed by the first and second sections, the internal cavity tapering from an open insertion portion at a first end of the device to an open exit portion at a second end of the device. The insertion portion has a larger dimension than the exit portion. When the first section and second section are substantially enclosing the internal cavity, a stented bioprosthetic valve may be inserted into the insertion portion and collapsed as it is moved toward and through the exit portion. The valve may then be loaded on an apparatus for insertion into the body.

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 is disposed within the stent and includes a plurality of leaflets. A collapsible and expandable frame formed of braided wires has a body portion and a lumen extending through the body portion for receiving the stent and the valve assembly. The frame may include features for holding the prosthetic heart valve in place in a patient.

Abstract: A system for delivering a medical implant includes an expandable member at least partially positioned inside the medical implant and operable to radially expand at least a portion of the medical implant to an expanded condition, first and second grasping mechanisms each adapted to grasp a portion of the medical implant, and a displacement mechanism operatively coupled to the first and second grasping mechanisms and configured to move the first and second grasping mechanisms between an inner position in which the first and second grasping mechanisms are relatively close to one another, and an outer position in which the first and second grasping mechanisms are relatively distant to one another. The movement of the first and second grasping mechanisms from the outer position to the inner position at least partially collapses the medical implant from the expanded condition to enable the medical implant to be repositioned if necessary.

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 is provided for collapsing a stented bioprosthetic valve, including first section and second sections, each spanning between first and second ends of the device. The second section of the device is associated with the first section to at least partially enclose an internal cavity formed by the first and second sections, the internal cavity tapering from an open insertion portion at a first end of the device to an open exit portion at a second end of the device. The insertion portion has a larger dimension than the exit portion. When the first section and second section are substantially enclosing the internal cavity, a stented bioprosthetic valve may be inserted into the insertion portion and collapsed as it is moved toward and through the exit portion. The valve may then be loaded on an apparatus for insertion into the body.

Abstract: A device is provided for collapsing a stented bioprosthetic valve, including first section and second sections, each spanning between first and second ends of the device. The second section of the device is associated with the first section to at least partially enclose an internal cavity formed by the first and second sections, the internal cavity tapering from an open insertion portion at a first end of the device to an open exit portion at a second end of the device. The insertion portion has a larger dimension than the exit portion. When the first section and second section are substantially enclosing the internal cavity, a stented bioprosthetic valve may be inserted into the insertion portion and collapsed as it is moved toward and through the exit portion. The valve may then be loaded on an apparatus for insertion into the body.

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.