Abstract: The present invention provides a single-use surgical cutting device for cutting a planar piece of tissue into a predetermined shape. The cutting device comprises a housing having one or more side walls, a top, a base, and a hollow interior portion. A blade retaining member is disposed within the housing between and substantially parallel to the top and base such that the blade retaining member can move vertically between the top and base. A blade defining a predetermined tissue shape is disposed on the bottom surface of the blade retaining member. A pressure mechanism creates potential energy for exerting a downward force on the top surface of the blade retaining member, such that when the blade retaining member is released, the pressure mechanism forces the blade retaining member downward with sufficient force to cut the piece of tissue. An actuator is configured to release the blade retaining member only once without disassembling the housing and resetting the pressure mechanism.

Abstract: An intraoperative tissue assessment device and method based on optical and mechanical techniques that allows a surgeon to assess certain mechanical properties of tissue samples. The device includes a cavity for housing and securing at least a portion of the tissue sample in communication with a pressurization source to inflate a portion of the tissue forming a dome of tissue having a height axis substantially perpendicular to the tissue sample secured within the cavity. The height of the dome of tissue along the height axis is generally proportional to the strength of the tissue sample. A source of illumination projects collimated light rays in the direction of the dome of tissue illuminating the dome of tissue and creating a Moiré fringe pattern, which may be used to determine the degree of anisotropy of the tissue sample when viewed through a viewing port arranged substantially directly above the dome of tissue.

Abstract: An intraoperative tissue assessment device and method based on optical and mechanical techniques that allows a surgeon to assess certain mechanical properties of tissue samples. The device includes a cavity for housing and securing at least a portion of the tissue sample in communication with a pressurization source to inflate a portion of the tissue forming a dome of tissue having a height axis substantially perpendicular to the tissue sample secured within the cavity. The height of the dome of tissue along the height axis is generally proportional to the strength of the tissue sample. A source of illumination projects collimated light rays in the direction of the dome of tissue illuminating the dome of tissue and creating a Moiré fringe pattern, which may be used to determine the degree of anisotropy of the tissue sample when viewed through a viewing port arranged substantially directly above the dome of tissue.

Abstract: A sizer for assessing the geometry of a heart valve annulus. The sizer preferably includes a circular sizing portion for measuring the diameter of the valve annulus. The sizing portion has radial spokes. The spokes are used to compare the symmetry of the commissures to the expected symmetry of a normal heart valve. The sizer preferably has one or more legs attached to the sizing portion for comparing the contour of the line of valve leaflet attachment to the expected contour of a normal heart valve having a diameter substantially equivalent to the measured diameter of the valve annulus.

Abstract: A sizer for assessing the geometry of a heart valve annulus including a handle portion for holding the sizer and a sizing portion. The sizing portion is preferably in the shape of an arch having an apex and two legs, each of which has a base adjoining the handle portion. The legs of the arched sizing portion are separated from each other by a predetermined distance that corresponds to the expected separation of commissures of a normal heart valve annulus. The height of the arch (measured from the base of each leg to the apex) corresponds to a predetermined leaflet height that approximates the expected height of a leaflet of a normal heart valve. For aortic valve reconstruction, the instrument is inserted into the opened aortic root following removal of the native valve tissue and is used to assess the distance between the commissures, the leaflet height, and the symmetry of the commissures of the exposed valve annulus.

Abstract: The present invention relates to an innovative roller cutting device, cutting template and method for cutting a tissue pattern. The invention allows a precise tissue pattern to be cut without dragging the material and possibly tearing the tissue as would often occur using a straight scalpel blade. The roller cutter and template described herein can be used for numerous surgical applications requiring precise cutting of tissue and other materials.

Abstract: A surgical instrument for holding a piece of tissue in a configuration of an open circulatory system valve to facilitate surgical attachment of the tissue to the patient's valve annulus. The instrument includes an inner member having a handle portion at one end and an inner tissue holding portion at the opposite end. The inner tissue holding portion includes one or more of inner leaves. An outer member disposed about the inner member includes an outer tissue holding portion having one or more of outer leaves that are complementary and can be engaged with the inner leaves. A collet or other actuator moves the outer leaves radially inward and outward with respect to the inner leaves. The outer leaves are separated from the inner leaves to allow placement of the tissue on the inner leaves. The outer leaves are then moved radially inward to hold the tissue between the leaves in a configuration of one or more leaflets of an open circulatory system valve to facilitate surgical attachment.

Abstract: A sizer for assessing the geometry of a heart valve annulus including a handle portion for holding the sizer and a sizing portion. The sizing portion is preferably in the shape of an arch having an apex and two legs, each of which has a base adjoining the handle portion. The legs of the arched sizing portion are separated from each other by a predetermined distance that corresponds to the expected separation of commissures of a normal heart valve annulus. The height of the arch (measured from the base of each leg to the apex) corresponds to a predetermined leaflet height that approximates the expected height of a leaflet of a normal heart valve. For aortic valve reconstruction, the instrument is inserted into the opened aortic root following removal of the native valve tissue and is used to assess the distance between the commissures, the leaflet height, and the symmetry of the commissures of the exposed valve annulus.

Abstract: An intraoperative tissue assessment device and method based on optical and mechanical techniques that allows a surgeon to assess certain mechanical properties of tissue samples. The device includes a cavity for housing and securing at least a portion of the tissue sample in communication with a pressurization source to inflate a portion of the tissue forming a dome of tissue having a height axis substantially perpendicular to the tissue sample secured within the cavity. The height of the dome of tissue along the height axis is generally proportional to the strength of the tissue sample. A source of illumination projects collimated light rays in the direction of the dome of tissue illuminating the dome of tissue and creating a Moiré fringe pattern, which may be used to determine the degree of anisotropy of the tissue sample when viewed through a viewing port arranged substantially directly above the dome of tissue.

Abstract: A new and unique, optimized, two-dimensional heart valve tissue pattern, valve, and a method of reconstructing a three-dimensional semilunar heart valve, or portion thereof. In one preferred embodiment, the two-dimensional valve tissue pattern, and method of the present invention, comprises a two-dimensional configuration developed and optimized by employing, in part, the anatomy of a three-dimensional human heart valve, and said two-dimensional configuration delimits a two dimensional area that corresponds to the shape of tissue to be used in the repair of at least one leaflet of a circulatory system semilunar valve, wherein the configuration delimits at least one segment, and up to all three segments, of a three segment “trefoil” shape.

Abstract: A standardized and reproducible method and instruments related thereto for repair of atrio-ventricular, aortic and pulmonary valves is provided.

Abstract: An improved set of stents for autologous tissue heart valves is provided. The stents are designed with the aid of a computer-aided-design (CAD) system, and nest within each other to securely clamp a piece of tissue which forms the leaflets of the heart valve. The geometrical features of the stents are designed to provide uniform nesting between the stents to prevent the formation of stress raisers on the tissue. Additionally, the windows in the stent posts are narrowed to prevent the suturing needle used during implantation of the valve from becoming lodged in the garter springs which clamp the outer stent to the inner stent. Finally, the sock covering the outer stent is bonded to the stent base at both upper and lower locations to isolate the bonds from the patient's blood flow.

Abstract: A method for repairing a heart valve comprising steps of sizing an annulus of a heart; harvesting tissue; cutting a trefoil pattern matched to the size of the annulus from the harvested tissue; forming a valve having at least one leaflet from said trefoil pattern, where the valve has a base with an edge portion of tissue extending around an outer periphery thereof; and suturing the edge portion to the exposed annulus; also disclosed is a method of repairing a heart valve comprising steps of: sizing an annulus of a heart at a repair site; harvesting tissue; cutting a trefoil pattern from the harvested tissue specific to the size of the annulus; providing first and second formers which are specific to the size of the annulus of the valve, forming a tri-leaflet valve from said trefoil pattern by engaging blades of said first former to corresponding blades of said second former with said trefoil pattern sandwiched therebetween; exposing an edge portion of tissue extending around an outer periphery of a base of th

Abstract: A method of manufacturing and testing a tissue heart valve during open heart surgery is disclosed. A piece of autologous tissue from the body of the patient is precisely cut according to the size of the open annulus remaining after excision of the patient's heart valve, with a plurality of holes being formed in the tissue. The tissue is situated between appropriately selected first and second stents so that the holes are registered with corresponding tissue alignment members in one of the stents, and the stents are positioned together to securely clamp the tissue therebetween. The constructed tissue heart valve is then mounted in a test chamber and visually inspected for leakage.

Abstract: A replaceable catheter system provides a way to replace an implantable sensor, electrode system, and/or fluid delivery/receiving system. The replaceable catheter system includes an implantable shunt, such as an arteriovenous shunt, attached to an implantable introducer. The introducer and implantable shunt are adapted for surgical implantation within a patient such that it extends from immediately below the patient's skin to the implantable shunt site. The replaceable catheter system further includes a replaceable catheter that is adapted to be contained within the introducer and properly aligned such that an implantable sensor, electrode system, and/or fluid delivery system that is carried by the replaceable catheter is placed in operative association with the implantable shunt and exposed to any fluids passing through the implantable shunt.

Abstract: A concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A tester for rapidly testing a tissue heart valve is provided comprising a substantially transparent viewing chamber having a plurality of size-specific mounts for mounting the valve within the chamber. The tester further comprises an element for displacing a volume of solution through the valve to test the opening and closing of the valve and to determine the amount of leakage through the valve when the valve is in a closed position.

Abstract: A method for assembling a concentric mating stent tissue heart valve which is capable of being assembled with a variety of tissue sources is provided. A plurality of prefabricated kits are also provided which enable the valve to be assembled with autogenous tissue in the limited time, i.e., 10 minutes or less, available in the operating room. A series of obturators may be used to size an annulus of the heart to be fitted. A precisely-configured cutting die is used to produce a precisely-cut tissue with a plurality of heart valve leaflets when the tissue is positioned between the first and second stents.

Abstract: A tissue heart valve test device which is capable of testing the valves in a rapid manner before implantation to ensure that there are no unacceptable leaks or flaws. The test device enables the valve to be tested in the operating room during the open heart procedure. The test device is configured with a chamber which allows the user to thoroughly visually inspect the valve as part of the test criteria. In addition, the test device is provided with size-specific mounts which are adapted to the particular valve to be tested.

Abstract: The present invention provides a prosthetic heart valve holder specifically configured to hold a prosthetic heart valve comprised of a stent. The heart valve holder assembly has three main components: a handle, a valve capture loop assembly and a valve retainer. The prosthetic heart valve is secured to the valve retainer by a loop of suture as the surgeon sutures or attaches the valve to the annulus of the heart. Thus, the valve holder assembly facilitates attachment of the prosthetic valve to the annulus so that the procedure may be performed in a time and labor efficient manner.

Abstract: A stentless heart valve assembled from autologous tissue is provided. The tissue is cut into a rectangular shape, folded, and stapled at several locations to form the cusps of the valve. The outer walls of the valve are pinched at the midpoint of each cusp to prevent the cusps from adhering to the valve walls. The ends of the rectangle are then stapled to form the annular valve itself.