Abstract: A delivery device (10) for an implantable medical device includes an inner shaft (26) extending in a longitudinal direction and defining a compartment (23) adapted to receive the medical device in an assembled condition, an outer shaft (22) surrounding a longitudinal portion of the inner shaft, and a distal sheath (24) operatively attached to the outer shaft (22). The distal sheath (24) is slidable between a first position enclosing the compartment (23) and a second position exposing the compartment (23) for deployment of the medical device. A sleeve 30 surrounds at least a longitudinal portion of the outer shaft (22) and provides a substantially blood tight bearing surface that facilitates sliding movement of the delivery device (10) in an introducer (2).

Abstract: A crimping tool for use with a collapsible prosthetic valve having a stent frame with a plurality of cell openings, and a valve structure assembled in the stent frame. The crimping tool includes a plurality of resilient tines defining an array around a longitudinal axis of the crimping tool. The array has a first cross-section in an expanded state and a second cross-section less than the first cross-section in a collapsed state. The plurality of tines are adapted to intersect the plurality of cell openings in an assembled position of the crimping tool on the prosthetic valve to prevent pinching of the valve structure by the stent frame as the prosthetic valve is collapsed.

Abstract: An ablation catheter comprises an elongated catheter body; at least one ablation element disposed in a distal portion which is adjacent the distal end of the catheter body; an illumination optical element disposed in the distal portion, the illumination optical element being light-transmissive to emit light from the illumination optical element to the targeted tissue region; and a collection optical element disposed in the distal portion, the collection optical element being light-transmissive to collect one or more of returned, backscattered or newly excited light from the targeted tissue region. The illumination or excitation optical element and the collection optical element are axially spaced from one another and axially optically isolated from one another within the distal portion to substantially prevent light from traveling between the illumination optical element and the collection optical element along a path within the distal portion.

Abstract: A device for repair of a heart valve leaflet includes an elongated body having a lumen extending therethrough in a longitudinal direction, a proximal end, and an open distal end. The device further includes a plurality of clips disposed at spaced positions within the lumen, the plurality of clips being configured and arranged to couple to a portion of the heart valve leaflet. At least one clip in the plurality of clips and the heart valve leaflet are capable of translation relative to one another in the longitudinal direction.

Abstract: A stent for use in a prosthetic heart valve has a plurality of expandable and collapsible closed cells, a portion of which form an annulus section adapted for placement within the annulus of the native heart valve. Anchor features of the stent residing within at least some closed cells are adapted to engage tissue of the heart, including native valve leaflets, the sinotubular junction, or another implanted device when the prosthetic valve is implanted in the heart. The anchor features may help to retain the prosthetic valve in position, without interfering with the opening and closing of the valve leaflets. Furthermore, the anchor features may be configured to allow the stent to be resheathed into a delivery device after the portion of the stent with the anchor feature has expanded out of the delivery device.

Abstract: A delivery device for a collapsible prosthetic heart valve includes a support shaft around which a compartment for the valve is defined, a distal sheath adapted to selectively cover and uncover the compartment and the valve, and a marker cage having a collapsed condition when the distal sheath covers the compartment and an expanded condition when the compartment is uncovered. The marker cage includes at least one rib having a radiopaque marker for determining the positioning of the valve as it is deployed. The valve may be assembled around the marker cage so that the marker cage does not interfere with the radial expansion of the valve during deployment.

Abstract: A prosthetic aortic valve includes an annular, annulus inflow portion that is designed to reside in or near the patient's native aortic valve annulus, and an annular, aortic outflow portion that is designed to reside in the patient's aorta downstream from at least a portion of the valsalva sinus. The annulus inflow portion and the aortic outflow portion are connected to one another by a plurality of connecting struts that are confined to regions near the commissures of the patient's native aortic valve. The connecting struts are designed to bulge out into the valsalva sinus to help anchor the prosthetic valve in place. The valve is circumferentially collapsible to a relatively small diameter for less-invasive delivery into the patient. The valve circumferentially expands to a larger operational diameter when deployed at the implant site.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

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 prosthetic aortic valve includes an annular, annulus inflow portion that is designed to reside in or near the patient's native aortic valve annulus, and an annular, aortic outflow portion that is designed to reside in the patient's aorta downstream from at least a portion of the valsalva sinus. The annulus inflow portion and the aortic outflow portion are connected to one another by a plurality of connecting struts that are confined to regions near the commissures of the patient's native aortic valve. The connecting struts are designed to bulge out into the valsalva sinus to help anchor the prosthetic valve in place. The valve is circumferentially collapsible to a relatively small diameter for less-invasive delivery into the patient. The valve circumferentially expands to a larger operational diameter when deployed at the implant site.

Abstract: A device 10 for gathering tissue of a heart valve leaflet 2 may include an outer tube 16 extending in an elongation direction, a capture tool 22 moveable in the outer tube between a contained position and a use position, and a tissue securing component 32 disposed at a distal end 17 of the outer tube and adapted to be applied to tissue 8 captured by the capture tool to hold the captured tissue in a gathered configuration. The capture tool may include a first element 20 and a second element 22 that are moveable relative to one another in the elongation direction. The first and second elements 20, 22 may be operable to capture tissue 8 of the heart valve leaflet 2 therebetween and to draw the captured tissue into the outer tube 16 in the gathered configuration.

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 10 for gathering tissue of a heart valve leaflet 2 may include an outer tube 16 extending in an elongation direction, a capture tool 22 moveable in the outer tube between a contained position and a use position, and a tissue securing component 32 disposed at a distal end 17 of the outer tube and adapted to be applied to tissue 8 captured by the capture tool to hold the captured tissue in a gathered configuration. The capture tool may include a first element 20 and a second element 22 that are moveable relative to one another in the elongation direction. The first and second elements 20, 22 may be operable to capture tissue 8 of the heart valve leaflet 2 therebetween and to draw the captured tissue into the outer tube 16 in the gathered configuration.

Abstract: A mandrel for molding polymer valve leaflets for heart valve prostheses is disclosed, including a body portion including an outer surface with ridges and contoured surfaces corresponding to the leaflets, the upper edge of the contoured surfaces corresponding to the free upper edge of the leaflets, and the mandrel including a mandrel extension above the body portion, and a gap extending around the mandrel between the upper edge of the contoured surface and the mandrel extension. A process for producing these polymer valve leaflets is also disclosed by dip coating with this mandrel and removing the polymer film created at the gap, preferably by applying suction or blowing thereto.

Abstract: Wound closure devices, systems, and methods may be used to close an opening, such as a puncture wound or incision, formed in tissue, such as heart tissue. A wound closure device may be configured and adapted to be placed within the puncture wound or incision to close and/or seal the puncture wound or incision. A bioadhesive may be used to strengthen the closure and/or seal of the puncture wound after placement of the wound closure device relative to the puncture wound.

Abstract: 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.

Abstract: A prosthetic heart valve includes a stent and a valve assembly attached to the stent. The stent has a longitudinal axis, a distal end and a proximal end adapted to reside adjacent the aortic annulus of a patient. The proximal end of the stent is oriented at an oblique angle to the longitudinal axis.

Abstract: A prosthetic heart valve is provided with a cuff having features which promote sealing with the native tissues even where the native tissues are irregular. The cuff may include a portion adapted to bear on the LVOT when the valve is implanted in a native aortic valve. The valve may include elements for biasing the cuff outwardly with respect to the stent body when the stent body is in an expanded condition. The cuff may have portions of different thickness distributed around the circumference of the valve in a pattern matching the shape of the opening defined by the native tissue. All or part of the cuff may be movable relative to the stent during implantation.

Abstract: A prosthetic heart valve includes a stent having an expanded configuration and a collapsed configuration, the stent in the expanded configuration having a longitudinal axis, an inflow end, an outflow end, a first portion adjacent the inflow end and a second portion adjacent the outflow end. The first portion includes a plurality of collapsible cells each having a perimeter and an open center; and the second portion includes a plurality of struts spaced from one another in an annular direction of the stent, the second portion of the stent being devoid of structure between annularly adjacent ones of the struts, whereby the annularly adjacent ones of the struts are not directly connected to one another. A valve assembly is supported by the stent.