Abstract: A delivery device for a stented heart valve includes a handle, an elongate shaft extending from a distal end of the handle, and a conical housing having a proximal end coupled to the elongate shaft and an open distal end, the conical housing having a conical lumen therein with a first internal diameter adjacent to the proximal end of the conical housing and a larger second internal diameter adjacent to the open distal end of the conical housing.

Abstract: A delivery device for a stented heart valve includes a handle, an elongate shaft extending from a distal end of the handle, and a conical housing having a proximal end coupled to the elongate shaft and an open distal end, the conical housing having a conical lumen therein with a first internal diameter adjacent to the proximal end of the conical housing and a larger second internal diameter adjacent to the open distal end of the conical housing.

Abstract: A delivery device for a stented heart valve comprises a handle, an elongate shaft extending from a distal end of the handle, and a conical housing having a proximal end coupled to the elongate shaft and an open distal end, the conical housing having a conical lumen therein with a first internal diameter adjacent to the proximal end of the conical housing and a larger second internal diameter adjacent to the open distal end of the conical housing.

Abstract: A delivery device for a stented heart valve comprises a handle, an inner catheter shaft extending from the handle and having an enlarged bumper element at a distal end, an outer catheter shaft extending from the handle and slidably coupled around the inner catheter shaft, and a retraction mechanism for controlling longitudinal movement of the outer catheter shaft relative to the inner catheter shaft. The outer catheter shaft includes a generally cylindrical housing at a distal end that is structured to receive the bumper element therein.

Abstract: Methods and systems for introducing a delivery device, having a prosthesis, in the heart at or near the apex of the heart are provided. The methods include the steps of piercing the apex of the heart with a tissue piercing end of the delivery device, advancing the prosthesis to the target site and disengaging the prosthesis from the delivery device at the target site for implantation. The valve replacement systems are configured to deliver a replacement heart valve to a target site in or near a heart. The valve replacement system includes a trocar or other suitable device to penetrate the heart at or near the apex of the heart, a delivery member that is movably disposed within the trocar, and a replacement cardiac valve disposed on the delivery member. The delivery member optionally includes mechanical or inflatable expanding members for implantating the prosthetic valve at the target site.

Abstract: A delivery device for a stented heart valve includes a handle, an elongate shaft extending from a distal end of the handle, and a conical housing having a proximal end coupled to the elongate shaft and an open distal end, the conical housing having a conical lumen therein with a first internal diameter adjacent to the proximal end of the conical housing and a larger second internal diameter adjacent to the open distal end of the conical housing.

Abstract: A delivery device for a stented heart valve that includes a handle, an inner catheter shaft extending from the handle and having an enlarged bumper element at a distal end, an outer catheter shaft extending from the handle and slidably coupled around the inner catheter shaft, and a retraction mechanism for controlling longitudinal movement of the outer catheter shaft relative to the inner catheter shaft. The outer catheter shaft includes a generally cylindrical housing at a distal end that is structured to receive the bumper element therein.

Abstract: Methods and assemblies are described for capturing embolic material in a blood vessel or other body cavity during cardiovascular or valve replacement and repair surgery, wherein access is provided through the apical area of the patient's heart. The distal embolic protection assembly generally comprises a sleeve having a lumen, an actuating member having proximal and distal ends, wherein the actuating member is movably disposed within the lumen, and a filter assembly coupled to the distal end of the actuating member. The filter assembly generally comprises a porous bag having an open proximal end, a collapsible and expandable frame that is coupled to the open proximal end of the porous bag, and at least one support spine disposed at least a part of the longitudinal axis of the porous bag. The porous bag is configured such that it permits blood to perfuse freely through while capturing embolic material and other debris.

Abstract: The present invention provides systems and methods for the repair, removal, and/or replacement of heart valves. The methods comprise introducing a delivery system into the heart, wherein a prosthesis is disposed on the delivery member attached to the delivery system, advancing the prosthesis to the target site, and disengaging the prosthesis from the delivery member at the target site for implantation. The present invention also provides implant systems for delivering a prosthesis to a target site in or near the heart. In one embodiment of the present invention, the implant system comprises a delivery system, an access system, and a prosthesis.

Abstract: A prosthetic heart valve assembly comprises a plurality of leaflets configured to replace the function of a native heart valve. Each leaflet comprises laminar pericardium tissue. Each leaflet has a coaptation edge formed by laser cutting. The tissue layers of each leaflet are fused together along an entire length of the coaptation edge, and tissue adjacent each coaptation edge does not have significant thermal energy damage.

Abstract: Methods and assemblies are described for capturing embolic material in a blood vessel or other body cavity during cardiovascular or valve replacement and repair surgery, wherein access is provided through the apical area of the patient's heart. The distal embolic protection assembly generally comprises a sleeve having a lumen, an actuating member having proximal and distal ends, wherein the actuating member is movably disposed within the lumen, and a filter assembly coupled to the distal end of the actuating member. The filter assembly generally comprises a porous bag having an open proximal end, a collapsible and expandable frame that is coupled to the open proximal end of the porous bag, and at least one support spine disposed at least a part of the longitudinal axis of the porous bag. The porous bag is configured such that it permits blood to perfuse freely through while capturing embolic material and other debris.

Abstract: The invention provides methods and systems for introducing a delivery device in the heart at or near the apex of the heart, wherein the delivery device includes a prosthesis, advancing the prosthesis to the target site, and disengaging the prosthesis from the delivery device at the target site for implantation. Specifically, the present invention provides valve replacement systems for delivering a replacement heart valve to a target site in or near a heart. The valve replacement system comprises a trocar or other suitable device to penetrate the heart at or near the apex of the heart, a delivery member that is movably disposed within the trocar, and a replacement cardiac valve disposed on the delivery member. The delivery member may further comprise mechanical or inflatable expanding members to facilitate implantation of the prosthetic valve at the target site.

Abstract: A crimping tool for crimping a stented heart valve comprises a housing having a front wall and a back wall, a compression assembly disposed between the front wall and the back wall and including a stent receiving chamber therewithin for receiving a stented heart valve, and a delivery device holder slidably coupled to the front wall of the housing. The compression assembly is movable between an uncrimped position and a crimped position to reduce the diameter of the stented heart valve.

Abstract: Methods and assemblies are described for capturing embolic material in a blood vessel or other body cavity during cardiovascular or valve replacement and repair surgery, wherein access is provided through the apical area of the patient's heart. The distal embolic protection assembly generally comprises a sleeve having a lumen, an actuating member having proximal and distal ends, wherein the actuating member is movably disposed within the lumen, and a filter assembly coupled to the distal end of the actuating member. The filter assembly generally comprises a porous bag having an open proximal end, a collapsible and expandable frame that is coupled to the open proximal end of the porous bag, and at least one support spine disposed at least a part of the longitudinal axis of the porous bag. The porous bag is configured such that it permits blood to perfuse freely through while capturing embolic material and other debris.

Abstract: A prosthetic heart valve assembly comprises a plurality of leaflets configured to replace the function of a native heart valve. Each leaflet comprises laminar pericardium tissue. Each leaflet has a coaptation edge formed by laser cutting. The tissue layers of each leaflet are fused together along an entire length of the coaptation edge, and tissue adjacent each coaptation edge does not have significant thermal energy damage.

Abstract: A method of cutting tissue for use as an implantable medical device employs a laser cutting system. The laser cutting system is computer controlled and includes a laser combined with a motion system. The laser precisely cuts segments out of source tissue according to predetermined pattern as designated by the computer. The cutting energy of the laser is selected so that the cut edges of the tissue segments are fused, melted or welded to discourage delamination or fraying, but communication of thermal energy into the segment beyond the edge is minimized to avoid damaging the tissue adjacent the edge.

Abstract: A replacement valve comprises a valve body having an inflow end, an outflow end, and a valve support structure, and a valve cuff surrounding the inflow end of the valve body. The valve support structure surrounds the valve body, and the valve cuff is coupled to the valve support structure. The valve cuff includes a skirt portion and at least one flange coupled to and protruding from the skirt portion, the at least one flange forming a seal around the inflow end of the valve body.

Abstract: Methods and assemblies are described for capturing embolic material in a blood vessel or other body cavity during cardiovascular or valve replacement and repair surgery, wherein access is provided through the apical area of the patient's heart. The distal embolic protection assembly generally comprises a sleeve having a lumen, an actuating member having proximal and distal ends, wherein the actuating member is movably disposed within the lumen, and a filter assembly coupled to the distal end of the actuating member. The filter assembly generally comprises a porous bag having an open proximal end, a collapsible and expandable frame that is coupled to the open proximal end of the porous bag, and at least one support spine disposed at least a part of the longitudinal axis of the porous bag. The porous bag is configured such that it permits blood to perfuse freely through while capturing embolic material and other debris.

Abstract: A method of cutting material for use in an implantable medical device employs a plotted laser cutting system. The laser cutting system is computer controlled and includes a laser combined with a motion system. The laser precisely cuts segments out of source material according to a predetermined pattern as designated by the computer. The segments are used in constructing implantable medical devices. The cutting energy of the laser is selected so that the cut edges of the segments are melted to discourage delamination or fraying, but communication of thermal energy into the segment beyond the edge is minimized to avoid damaging the segment adjacent the edge.

Abstract: A method of cutting material for use in an implantable medical device employs a plotted laser cutting system. The laser cutting system is computer controlled and includes a laser combined with a motion system. The laser precisely cuts segments out of source material according to a predetermined pattern as designated by the computer. The segments are used in constructing implantable medical devices. The cutting energy of the laser is selected so that the cut edges of the segments are melted to discourage delamination or fraying, but communication of thermal energy into the segment beyond the edge is minimized to avoid damaging the segment adjacent the edge.