Abstract: Anatomical orifice sizers that are optimally proportional to an associated prosthetic device such as a heart valve, and methods of use are provided. The sizers are desirably slightly larger than the rigid mounting diameter of the corresponding heart valve. The heart valve sizer may be cylindrical and have a diameter about 0.3 mm larger than the valve mounting diameter. The sizer preferably has a length of between about 19 mm to 22 mm, and the edges are desirably rounded to a minimum 1 mm radius. The method includes providing a set of cylindrical sizers having varying diameters; sequentially inserting at least two of the sizers through the annulus; measuring the push force needed to pass each sizer through the annulus; selecting a valve corresponding to the sizer for which the measured push force is between about 150 and 300 grams.

Abstract: A system and method to facilitate thickness measurement of bio-material workpiece, preferably a sheet, and to topographically map the sheet into similar thickness zones for later use. In particular, the system may include a three-axis programmable controller for manipulating a bio-material workpiece with respect to a thickness measurement head. The measurement head may include a plurality of sensors for simultaneous measurement of a plurality of points, with the sensors being adapted to contact the sheet or not. A robust human-machine interface is also provided for process control, preferably including a touch-screen monitor. A marking head may be provided for marking the zones or otherwise indicating the thickness in different areas. Two platens are desirably used in parallel for increased thoughput; the workpiece on one platen may be measured while the other is marked. The system and method are especially suited for assessing and marking pericardial tissue for forming heart valve leaflets.

Abstract: A sizer measures a valve annulus to determine a size of an artificial heart valve to be sewn in the valve annulus during heart-valve replacement surgery. The sizer includes a support member and a resilient member. The support member has a size corresponding to the size of one of a plurality of artificial heart valves. The resilient member is disposed about the support member and has a resiliency substantially equal to the resiliency of a sewing ring of the artificial heart valve. Accordingly, when a surgeon inserts the sizer into a valve annulus, the resilient member conforms to the shape of the valve annulus much like the sewing ring will conform when positioned in the annulus and sewn in place. The surgeon is therefore able to determine more accurately the size of the annulus and, thereafter, to select a properly sized artificial valve.

Abstract: A stentless aortic bioprosthesis having patent, non-ligated coronary artery segments extending therefrom, and methods for surgical replacement of aortic and/or non-aortic (e.g., pulmonary) heart valves with such stentless aortic bioprosthesis. The presence of the patent, non-ligated coronary segments facilitates end to end anastomosis of the patient's native coronary arteries and/or existing coronary artery bypass grafts to the coronary segments of the bioprosthesis even when such native coronary arteries (or coronary grafts) are too short to reach the wall of the aortic segment of the bioprosthesis. The presence of such patent, non-ligated coronary segments also eliminates the need for removal of a “button” or segment of the native aorta in connection with the native coronary artery segments prior to implantation of the bioprosthesis, and is thus advantageous for patients whose ascending aorta is diseased or otherwise compromised.

Abstract: Biocompatible surfaces on medical devices, particularly those formed of synthetic materials, are produced by providing coating compounds having crosslinked regions capable of entrapping biocompatible molecules on the surfaces of medical devices in order to form a stable base layer. The crosslinked base layer is lubricious and is able to function as an entrapping or coupling site for additional biocompatible agents, which agents may be stably incorporated into its crosslinked lattice. Thus, the coatings of the present invention have enhanced lubricity and may also have antimicrobial, protein-repelling, and/or antithrombotic properties. The present invention thus discloses novel, stable, biocompatible coating compositions, devices coated with the compositions of the present invention, methods of making and applying such compounds, and methods of preparing and using devices and apparatus coated with such compositions.

Abstract: A heart valve with a structural stent and radially moveable cusps and commissures. The stent may be of three separate elements, each having a cusp portion and two commissure portions. The commissures may be pivotally or flexibly coupled, and may separate into independent leaflets. A connecting band may be provided that follows the cusps and commissures and extend outwardly. The valve may be connected to the natural tissue along the undulating connecting band. A multi-legged holder having legs alternating between each cusp and commissure may be used for implantation. A method of implantation is also disclosed, as is a system for implanting independent valve leaflets in the native annulus.

Abstract: An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line.

Abstract: Heart valve leaflet selection methods and apparatuses which subject individual leaflets to loads and measure the resulting deflection to more reliably group leaflets of similar physical characteristics for later assembly in prosthetic heart valves. The deflection testing may be accomplished using a variety of test set ups which are designed to impart a load on the leaflet which simulates the actual loading within a heart valve. The results from a number of deflection tests are used to categorize individual leaflets, which data can be combined with other data regarding the characteristics of the leaflet to better select leaflets for assembly into a multi-leaflet heart valve. In one embodiment, the deflection test is combined with an intrinsic load test, and leaflets having similar deflection and intrinsic load values used in the same heart valve.

Abstract: An infra-annular annuloplasty prosthesis is disclosed including a flexibly semi-rigid frame, a portion of which is shaped to conform to the scalloped configuration of the normal circumference of an arterial heart valve annulus. Axially projecting legs spaced circumferentially to correspond to the location of tissue adjacent to the valve commissures are provided for support and anchoring of the annulus-conforming portion to the dense fibrous tissues adjacent each commissure. The prosthesis includes a one-or two-part frame having scalloped upper and lower edges defining peaks and valleys. The upper edge is shaped to follow the contour of the tissue underneath the valve leaflets, and thus supports the leaflets and aortic wall from below. The lower edge is similarly scallop-shaped, but with less pronounced peaks and valleys than the upper edge, and is thus shaped to conform to the aortic annulus shape and provide support directly thereto.

Abstract: An expandable annuloplasty ring which may either expand spontaneously, in situ, as the patient grows or be expanded by surgical intervention by balloon dilatation. The distensible annuloplasty ring of the invention may be usable in pediatric patients whose growth, subsequent to surgical implantation of the ring, will necessitate subsequent enlargement of the ring to accommodate growth of the annulus. The ring may include relatively expandable segments to enable the enlargement thereof. The ring segments may include engaging teeth which cooperate with notches or slots formed in the tubes to provide some resistance to ring distention, while preventing collapse of the ring in the opposite direction. The teeth may be of different sizes or shapes to regulate the amount of force needed to expand the ring at different stages of the patient's growth.

Abstract: An assembly for holding a substantially flexible suture guide of predetermined length in a substantially taut position used to achieve a suture line having a dimension equal to the length of the suture guide, such as the circumference about a heart valve annulus. The assembly includes a rigid suture guide holder having a surface against which the length of suture guide is releasably positioned. The guide holder can have a shape or geometry, such as a circumference or circumferential segment, equivalent to the shape or geometry of the intended suture line. The shape of the guide holder can therefore be selected to hold the suture guide in the shape most advantageous to placing the desired suture line.

Abstract: A design and method of implantation is disclosed for a flexible annuloplasty system for repairing a valve in a patient's heart. The annuloplasty system includes an elongate, flexible band with a needle attached to one end of the band and a fit adjuster attached to the other end of the band. The band is made of silicone and includes a plurality of fibers that are configured to prevent axial elongation of the band. In addition, the plurality of fibers ensure that a suture will catch on the fibers and prevent the suture from tearing out of the band.

Abstract: A minimally invasive approach for surgery on portions of the heart and great vessels located between a point approximately three centimeters above supra annular ridge and the mid ventricular cavity. A parasternal incision is made extending across a predetermined number of costal cartilage, e.g., a right parasternal incision extending from the lower edge of the second costal cartilage to the superior edge of the fifth costal cartilage. One or more costal cartilages, e.g., the third and fourth, are then excised to provide access to the portion of the heart or great vessels of interest, and a desired procedure completed. The minimally invasive approach enables repair or replacement of the mitral or aortic valve.

Abstract: A sewing ring for implantation of prosthetic heart valves has a compliant ring member made of a plurality of cells. The ring member may be silicon rubber and the cells defined within outer walls and inner ribs. A biocompatible fabric covering surrounds at least an outer portion of the ring member, and the assembly mounts to a mechanical or tissue-type prosthetic heart valve. The ring member has a radial dimension and cross-sectional area sufficient to ensure a large coaptation area between the sewing ring and the annulus tissue so as to enable adequate attachment of the valve without load distributing devices such as pledgets. A version of the sewing ring for attachment to the mitral annulus includes a curved coaptation edge, while another embodiment for attachment to the aortic annulus has a tapered outer edge with increased radial and axial dimensions.

Abstract: A stentless aortic bioprosthesis having patent, non-ligated coronary artery segments extending therefrom, and methods for surgical replacement of aortic and/or non-aortic (e.g., pulmonary) heart valves with such stentless aortic bioprosthesis. The presence of the patent, non-ligated coronary segments facilitates end to end anastomosis of the patient's native coronary arteries and/or existing coronary artery bypass grafts to the coronary segments of the bioprosthesis even when such native coronary arteries (or coronary grafts) are too short to reach the wall of the aortic segment of the bioprosthesis. The presence of such patent, non-ligated coronary segments also eliminates the need for removal of a "button" or segment of the native aorta in connection with the native coronary artery segments prior to implantation of the bioprosthesis, and is thus advantageous for patients whose ascending aorta is diseased or otherwise compromised.

Abstract: Methods for rotating a heart valve body rotatably mounted within a sewing ring. The valve body includes a plurality of drive surfaces on an inner periphery, and a rotator has a plurality of drive surfaces on an exterior periphery. The drive and driven surfaces are in registration only in discrete relative orientations of the two parts about a common axis of rotation. The drive surfaces may be greater in number than the driven surfaces, to reduce the rotational angle that the rotator must be turned before registering with the valve body. The drive and driven surfaces may be formed as flats on each respective part. In one embodiment, the rotator includes a cylindrical distal end with three pairs of diametrically opposed external flats, and the valve body includes a single pair of diametrically opposed internal flats. The rotator is designed so that a surgeon need only rotate it a maximum of 90.degree. in either direction.

Abstract: A magnetically-driven centrifugal blood pump includes a housing and an impeller mounted for rotation within. The impeller includes a generally disk-shaped base plate and a plurality of curvilinear vanes extending axially upward therefrom. The vanes project radially outward from the base plate approximately one-third of their curvilinear length. The housing includes a rear wall spaced from the impeller base plate across a constant gap, with a sloped transition wall surrounding the rear wall and joining it to a peripheral wall. A tangential outlet is provided in the peripheral wall. A front wall extends inward from the peripheral wall with a slight conicity to an axial inlet. The vanes each have a front edge which slopes away from the front wall in the radially outward direction to provide a widening gap therebetween. The vanes have inner ends which together define a vane-free inner region below and slightly larger than the inlet.

Abstract: A prosthetic mechanical valve includes a base portion defining a through blood flow pathway closed by at least a pair of valve leaflets. The valve leaflets are pivotally carried by the base portion and movable in response to dynamic blood fluid pressures between a first position at which the leaflets close blood flow through the pathway and a second open position allowing blood flow in the pathway. A pair of confronting magnets are carried one to each of the pair of valve leaflets and attract one another. The magnetic forces of attraction between the pair of magnets imparts a biasing torque to the valve leaflets which tends to synchronize pivotal movements of the leaflets, cushions their sealing contact, quiets valve operation, and biases the leaflets toward a third partially open position. As a result, under conditions of nearly balanced blood fluid pressures across the pair of valve leaflet they anticipatorily open toward their third position to improve pumping effectiveness.

Abstract: A combined cardiotomy and venous blood reservoir according to a preferred embodiment of the invention provides a separate in-flow path for both cardiotomy fluid and for venous blood, and includes a cardiotomy fluid filter element also serving as an initial de-foamer. The cardiotomy fluid is de-foamed, filtered, and again de-foamed. The venous blood is de-foamed, and then both fluids are combined for flow from the reservoir. The filter area provided for cardiotomy fluid is advantageously separated from the area of a final de-foamer element. Thus, both the cardiotomy fluid and venous blood may flow through this final de-foamer element simultaneously along separate flow paths. The reservoir design provides greater freedom in selecting adequate filter area for the cardiotomy fluid, while allowing the selection of effective de-foamer element areas in order to achieve acceptable flow rates for both cardiotomy fluid and for venous blood under various conditions of operation for the reservoir.

Abstract: Methods for treating glutaraldehyde-fixed collagenous tissues to mitigate their propensity for subsequent calcification and to improve durability. Collagenous tissues which have been harvested and cross-linked by glutaraldehyde are exposed to a carboxyl activating agent to convert the free carboxyl (COOH) groups of the collagen molecules to activated carboxyl moieties (e.g., o-acylisourea). Thereafter, the collagenous tissue is exposed to a compound capable of reacting with the activated carboxyl moieties (e.g., o-acylisourea) to form non-carboxyl side groups. Monofunctional and multi-functional amines are examples of compounds which may be utilized to react with the activated carboxyl moieties to form such non-carboxyl side groups. Thereafter, the collagenous tissue is again exposed to glutaraldehyde. If the non-carboxyl side groups have functional amino groups (NH.sub.