Patent ID: 12220312

DETAILED DESCRIPTION OF THE EMBODIMENTS

The terminology used herein is for the purpose of describing example embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, integers, steps, operations, cells, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, cells, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.

“Substantially” is intended to mean a quantity, property, or value that is present to a great or significant extent and less than, more than or equal to total. For example, “substantially vertical” may be less than, greater than, or equal to completely vertical.

“About” is intended to mean a quantity, property, or value that is present at ±10%. Throughout this disclosure, the numerical values represent approximate measures or limits to ranges to encompass minor deviations from the given values and embodiments having about the value mentioned as well as those having exactly the value mentioned. Other than in the working examples provided at the end of the detailed description, all numerical values of parameters (e.g., of quantities or conditions) in this specification, including the appended claims, are to be understood as being modified in all instances by the term “about” whether or not “about” actually appears before the numerical value. “About” indicates that the stated numerical value allows some slight imprecision (with some approach to exactness in the value; approximately or reasonably close to the value; nearly). If the imprecision provided by “about” is not otherwise understood in the art with this ordinary meaning, then “about” as used herein indicates at least variations that may arise from ordinary methods of measuring and using such parameters. In addition, disclosure of ranges includes disclosure of all values and further divided ranges within the entire range, including endpoints given for the ranges.

Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the recited range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein.

References to “embodiment” or “variant”, e.g., “one embodiment,” “an embodiment,” “example embodiment,” “various embodiments,” etc., may indicate that the embodiment(s) or variant(s) of the invention so described may include a particular feature, structure, or characteristic, but not every embodiment necessarily includes the particular feature, structure, or characteristic. Further, repeated use of the phrase “in one embodiment,” or “in an exemplary embodiment,” do not necessarily refer to the same embodiment or variant, although they may.

As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts. Unless otherwise expressly stated, it is in no way intended that any method or aspect set forth herein be construed as requiring that its steps be performed in a specific order. Accordingly, where a method claim does not specifically state in the claims or descriptions that the steps are to be limited to a specific order, it is in no way intended that an order be inferred, in any respect. This holds for any possible non-express basis for interpretation, including matters of logic with respect to arrangement of steps or operational flow, plain meaning derived from grammatical organization or punctuation, or the number or type of aspects described in the specification.

The term “metal material” is intended to refer to metals, alloyed metals or pseudometals.

For purposes of this application, the terms “pseudometal” and “pseudometallic” are intended to mean materials which exhibit material characteristics substantially the same as metals. Examples of pseudometallic materials include, without limitation, composite materials, polymers, and ceramics. Composite materials are composed of a matrix material reinforced with any of a variety of fibers made from ceramics, metals, carbon, or polymers.

As used in this application the term “layer” is intended to mean a substantially uniform material limited by interfaces between it and adjacent other layers, substrate, or environment. The interface region between adjacent layers is an inhomogeneous region in which extensive thermodynamic parameters may change. Different layers are not necessarily characterized by different values of the extensive thermodynamic parameters but at the interface, there is a local change at least in some parameters. For example, the interface between two steel layers that are identical in composition and microstructure may be characterized by a high local concentration of grain boundaries due to an interruption of the film growth process. Thus, the interface between layers is not necessarily different in chemical composition if it is different in structure.

The term “build axis” or “build direction” is intended to refer to the deposition axis in the material. For example, as a material is being deposited onto a substrate, the thickness or Z-axis of the material being deposited will increase, this is the build axis of the material.

The terms “circumferential” or “circumferential axis” is intended to refer to the radial direction of a tubular, cylindrical or annular material or to the Y-axis of a polygonal material.

The terms “longitudinal,” “longitudinal axis,” or “tube axis” are intended to refer to an elongate aspect or axis of a material or to the X-axis of the material.

The term “film” is intended to encompass both thick and thin films and includes material layers, coatings and/or discrete materials regardless of the geometric configuration of the material.

The term “thick film” is intended to mean a film or a layer of a film having a thickness greater than 10 micrometers.

The term “thin film” is intended to mean a film or a layer of a film having a thickness less than or equal to 10 micrometers.

The term “supravalvular” is intended to mean above the cardiac valve, i.e., on the superior or cranial side of a valve.

The term “infravalvular” is intended to mean below the cardiac valve, i.e., on the inferior or caudal side of a valve.

This detailed description of exemplary embodiments makes reference to the accompanying drawings, which show exemplary embodiments by way of illustration. While these exemplary embodiments are described in sufficient detail to enable those skilled in the art to practice the disclosure, it should be understood that other embodiments may be realized and that logical changes and adaptations in design and construction may be made in accordance with this disclosure and the teachings herein without departing from the spirit and scope of the disclosure. Thus, the detailed description herein is presented for purposes of illustration only and not for purposes of limitation.

The cardiac valve10of the present invention is preferably made of a metal or pseudometal material fabricated as a single unitary hypotube. Preferably, the single unitary hypotube is formed by physical vapor deposition (PVD) of metal, metal alloy or pseudometal onto a substrate configured to form the precursor hypotube structure. Sputter deposition of either thick films or thin films is a preferred form of depositing the metal, metal alloy, or pseudometal to make the single unitary hypotube precursor for making the variants of the cardiac valve10according to the present invention. The deposited hypotube is then laser cut to form a lattice frame structure12. The lattice frame structure12is configured to have a main body portion25including a plurality of biased cells13, including spring struts22, valve leaflet portions24including biasing projections17, and, optionally, distal anchoring projections18.

The main body portion25, when diametrically expanded, is composed of first struts14that are helically oriented in a first circumferential direction along a longitudinal axis of the lattice frame structure12and second struts15that are helically oriented in a second circumferential direction along the longitudinal axis of the lattice frame structure12. The first circumferential direction and the second circumferential direction may be opposing or offset from one and other such that the first struts14and the second struts15intersect to form biased cells13of the lattice frame structure12. As with laser-cutting intravascular stents, the plurality of first struts14and the plurality of second struts15are formed cutting a plurality of slots in the hypotube precursor in a pattern such that the land areas between slots forms the plurality of first struts14and the plurality of second struts15, respectively. A spring strut22is provided in the biased cells13within the lattice frame structure12. Finally, the biasing projections17project longitudinally from at least some of the biased cells13, preferably on a terminal row of biased cells at either or both a proximal and distal end of the lattice frame structure12.

The lattice frame structure12is preferably made of a shape memory or superelastic metal material, such as, for example, binary, ternary, quaternary, or greater nickel-titanium based alloys. Examples of metal materials suitable for use in fabricating the lattice frame structure12are metal materials material is selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum, hafnium, tungsten, rhenium, iridium, bismuth, iron, and alloys thereof, for example, nickel-titanium, nickel-titanium-cobalt, nickel-titanium-chromium, zirconium-titanium-tantalum alloys, or stainless steel. The foregoing metal materials are well-suited for physical vapor deposition to form the metal hypotube and tolerate post-deposition laser cutting and electropolishing to form the lattice frame structure12, as well as subsequent shape setting of the valve leaflet portions24, the main body portion25, and/or distal anchor projections18.

The valve leaflet portions24extends outward along a longitudinal axis of the main body portion25. The valve leaflet portions24are co-extensive with the main body portion25of the lattice frame structure12and are formed by sections of the plurality of first struts14and the plurality of second struts15. Alternatively, the valve leaflet portions24may be joined to the plurality of first struts14and/or the plurality of second struts15, such as by welding or other means of joining known in the art. The valve leaflet portions24may have different constructs across the different variants of the cardiac valve of the present disclosure. For example, the valve leaflet portions24may have a plurality of biasing projections17extending distally from an end-most row of the main body portion25formed by the first struts14and the plurality of second struts15. The biasing projections17are configured to support a polymer valve leaflet formed by a polymer covering over the biasing projections17.

Each of the variants of the cardiac valve of the present disclosure are comprised generally of a main body portion25and a plurality of valve leaflet portions24. The main body portion24of each variant is formed of a plurality of first struts14and plurality of second struts15. The plurality of first struts14and the plurality of second struts15intersect one and other to form generally quadrilateral-shaped biased cells13of the main body portion25. According to one example, the plurality of first struts14and the plurality of second struts15are defined by slot patterns formed in the precursor metal hypotube and have opposing helical orientations about a circumference of the main body portion25. The main body portion25terminates, at one end thereof, in a generally sinusoidal or zig-zag configuration formed by the plurality of first struts14and the plurality of second struts15defining petal-like projections from the main body portion25. At least two spaces are defined between adjacent pairs of the petal-like projections at the end of the main body portion25and are generally V- or U-shaped. Each of the petal-like projections and at least two of spaces23define a valve leaflet portion24of the cardiac valve10.

The variants of the cardiac valve of the present disclosure differ in the construct or configuration of the valve leaflet portions24. For example, the cardiac valve10inFIG.1has valve leaflet portions24that are at least partially formed by the plurality of first struts14and the plurality of second struts configured to form petal-like projections extending from an end of the main body portion25. The valve leaflet portions24have a generally sinusoidal terminal end11having distal apices19and proximal apices21. The sinusoidal terminal end11may simply be a relatively wider or thicker portion of a first strut14and/or a second strut15positioned at a most distal terminal end of the valve leaflet portion24. The generally sinusoidal terminal end11and the valve leaflet portions24form the petal-like projections between the distal apices19and the proximal apices21that are spaced-apart from each other about a circumferential axis of the cardiac valve10.

The plurality of biasing projections17extend along a longitudinal axis of the lattice frame structure12and project from an end row of cells in the lattice frame structure12. The biasing projections17may project distally from the generally sinusoidal terminal end11of the valve leaflet portions24as illustrated inFIG.1. Alternatively, the biasing projections17may intersect at least some of the biased cells13defined by the plurality of first struts14and the plurality of second struts15of the sinusoidal terminal end11row of the lattice frame structure12. Optionally, biasing projections17are contiguous with the spring struts22and extend beyond the sinusoidal terminal end11of the lattice frame structure12. In any of the foregoing described configurations, the biasing projections17are joined, coupled, integral with, and/or co-extensive with at least some of the biased cells13and are configured to move radially inward and outward toward a central axis of the cardiac valve10under at least partial influence of the biased cells13flexing.

Distal anchor projections18project distally from proximal apices21of the valve leaflet portions24. The distal anchor projections18and/or the biasing projections17may have a width or a thickness that tapers along their length.

The distal anchor projections18, the spring struts22, and the biasing projections17may also be laser cut from the original hypotube or may be formed as separate components and either deposited onto the lattice frame structure12by physical vapor deposition or otherwise joined or coupled to the lattice frame structure12.

FIG.2depicts a biased cell13showing an arrangement of the first struts14and second struts15defining four sides of and extending between the four sides of the biased cell13and a spring strut22extending diagonally between the included angles of opposing corners of the biased cell13.

Upon application of a bending force30to a corner of biased cell13, in which the spring strut22is present, such as by applying opposing forces32,34to open corners of the biased cell, the biased cell13bends out-of-plane and, upon release of bending force30or opposing forces32,34, returns to the in-plane position. Both the bending force30and the opposing forces32represent the strain forces that will be applied to the cardiac valve10valve leaflets during operation of the valves once implanted. The out-of-plane flexion bending of the biased cell13of valve leaflet24and recovery of the bending serves to ensure apposition of valve leaflets24during valve closure and mechanical support for the valve leaflet24during both valve opening and closure.

Upon application of opposing forces32,34orthogonal to a longitudinal axis of spring strut22the apices of the biased cell13exert a compressive force onto the spring strut22, which then flexes under the influence of the compressive force and allows the biased cell13to flex out-of-plane. Out-of-plane flexion of the biased cell13, in turn, transfers a motive force to the biasing projection17(not shown) causing the biasing projection to deflect inward toward the central opening of the cardiac valve10.

As shown inFIG.1, a polymer covering or coating is provided on the valve leaflet portions24that subtends the space between pairs of distal apices19and covers circumferentially adjacent petal-like projections of the valve leaflet portions24. In this manner, the valve leaflet portions24are embedded in, covered by, or coated with a coherent polymer material that acts as valve leaflets for the cardiac valve10.

The polymer covering28also covers to covers the biasing projections17projecting from the sinusoidal terminal end11of the valve leaflets portions24and subtends the spaces23between adjacent pairs of the biasing projections17. The polymer covering28is employed to both form the valve leaflets and achieve valve competency without backflow blood leakage or regurgitation. The basic properties of the desirable polymer include: 1) low thrombogenicity; 2) fatigue resistance; 3) high material strength allowing for thin coating or covering of the first struts14, second struts15, biasing projections17, as well as the distal anchor projections18, while providing a webbing that subtends open space between the foregoing; and 4) high adhesion strength to the lattice frame structure12. The polymer is preferably an elastomer that is configured to accommodate conformational changes of the valve leaflet sections24during valve opening and/or closing. Flexible non-elastomeric polymers may be employed provided that they have sufficient pliability, conformability, and fatigue resistance to function as valve leaflets at small material thicknesses. A wide variety of biocompatible polymers may be used as the embedding polymer for the valve leaflets. For example, polytetrafluoroethylene (PTFE), urethanes, such as polyurethane, poly(styrene-b-isobutylene-b-styrene (SIBS), poly (D, L-lactic acid)(PLA) and/or poly (D, L-lactic-co-glycolic acid) (PLGA), and/or polyimides, such as poly (4,4′-oxydiphenylene-pyromellitimide (KAPTON, E.I. du Pont de Nemours and Company, Wilmington, Delaware) may be useful as the polymer for the valve leaflets in the transluminal cardiac valve of the present invention.

The polymer may be applied by a wide variety of methods, depending upon the polymer selected, such as, for example, by dip coating, spraying, electrospinning, sintering, or vapor deposition, among other methods. Microporous microstructures in the polymer may be created, such as by electrospinning or by expansion of PTFE to expanded PTFE (ePTFE) prior to covering the cardiac valve.

Microporous microstructures in the polymer covering may be provided to enhance protein and cellular adhesion to the polymer. Enhanced protein and/or cellular adhesion to the valve leaflets and/or other portions of the cardiac valve may also be achieved by other methods, such as by texturing, surface charge manipulation, or the like.

The lattice frame structure12is preferably made of bare-metal to achieve adequate anchoring against and exclusion of the compressed native valve by pillowing effect. Both the anchoring and exclusion of the native valve may be complemented by other securing features on the lattice frame structure12, such as barbs (not shown). The proximal end of the main body portion25may include one or more anchoring projections221(shown inFIGS.12A,12B,13and15) that project from the proximal end of the main body portion25and may be shape-set to flare radially outward and open toward the atrial or ventricular outflow to facilitate blood flow from the atrium or ventricle and into and through the cardiac valve10. This proximal flare is also useful during deployment to stabilize the valve during a retrograde femoral approach during implantation. Further anchoring above the valve plane may also be achieved by providing anchoring projections originating at commissures between adjacent valve leaflet sections24that are shape set to project radially or circumferentially outward away from a central longitudinal axis of the cardiac valve10.

FIG.3is a diagrammatic plan view of a biased cell300. Biased cell300, like biased cell13, is bounded by a pair of first strut members304and second strut members305and has a spring strut322extending longitudinally between the second strut member305and positioned intermediate between a pair of first strut members304. The spring strut322projects outward from the biased cell300along a longitudinal axis thereof. Like biased cell13, biased cell300is formed of a unitary, monolithic hypotube that is machined, such as by laser cutting, with a plurality of slots defining the first strut members304, the second strut members305and the spring strut322. The hypotube may be made of shape memory, superelastic or plastically deformable, i.e., balloon expandable materials, as discussed below.

FIG.4is a diagrammatic side elevational view of the biased cell300in a planar unstrained state where no lateral, in the case of a planar lattice structure, or circumferential, in the case of a tubular lattice structure, force is applied to the biased cell300.

FIG.5is a diagrammatic plan view of the biased cell300illustrating expansion of the biased cell300as a result of a lateral force applied to the second strut members305causing the first strut members to open to a diamond shape while exerting an axially compressive strain to that part of the spring strut322that extends between the second strut members305. As shown inFIG.9, the axially compressive strain exerted on spring strut322, causes the biased cell300to deform out-of-plane and the portion of spring strut322that projects longitudinally from biased cell300deforms out-of-plane as well.

The out-of-plane deflection of the projecting portion of spring strut322is advantageously employed in the case of a valve leaflet to act as a spring strut as shown inFIGS.7A and7Bwherein the spring strut portion of spring strut322angularly deflects310from the longitudinal axis of the biased cell300. When employed as a valve leaflet spring strut, a polymer covering350extends between a plurality of spring struts to form the valve leaflet. The polymer covering350, as shown inFIG.8, forming the valve leaflets opens and closes under the influence of both the blood pressure gradient across the valve, and the spring strut portion of the spring strut322.

The spring strut322, when fabricated of a shape memory or superelastic material, is capable of shape setting to form the curvature of the valve leaflets and program the amplitude of deflection of the spring strut portion of the spring strut322. Similarly, the spring strut322can be formed to have one or more tapers or have one or more strain relief sections that will modulate the amplitude of deflection of the spring strut portion of the spring strut322as well as positively affect its fatigue resistance.

FIGS.9A and9Billustrate a bicuspid cardiac valve60in accordance with the present invention.FIG.9Adepicts the valve leaflets66in a closed position with the distal ends of each valve leaflet66in apposition with each other.FIG.9Billustrates the valve leaflets66in their open position creating a generally elliptical blood flow opening62that allows blood flow through the bicuspid cardiac valve60.

FIGS.10A and10Billustrate a tricuspid cardiac valve70in accordance with the present invention.FIG.10Adepicts the valve leaflets76in a closed position with the distal ends of each valve leaflet76in apposition with each other.FIG.10Billustrates the valve leaflets76in their open position creating a generally three-sided hypocycloid blood flow opening72that allows blood flow through the tricuspid cardiac valve70.

FIGS.11A and11Billustrate a quadricuspid cardiac valve80in accordance with the present invention.FIG.11Adepicts the valve leaflets86in a closed position with the distal ends of each valve leaflet86in apposition with another valve leaflet86.FIG.11Billustrates the valve leaflets86in their open position creating a generally four sided hypocycloid blood flow opening82that allows blood flow through the quadricuspid cardiac valve80.

FIG.12AandFIG.12B, illustrate an infra-valvular perspective view and a supra-valvular perspective view of the cardiac valve200, respectively, showing a tricuspid valve embodiment as represented by three petal-like valve leaflet sections about the circumference of cardiac valve200. It will be understood that a bicuspid variant of the cardiac valve200would have two diametrically opposing petal-like valve leaflet sections about the circumference of the cardiac valve, whereas a quadricuspid variant of the cardiac valve200would have four petal-like valve leaflet sections about the circumference of the cardiac valve.

Each of the anchoring projections221and/or the distal anchor projections18may have a rounded distal or proximal terminus onto which a radiopaque marker may be swaged or otherwise joined or applied. By providing radiopaque markers at the rounded distal or proximal terminus, the proximal and distal aspects of the cardiac valve10will be visible under fluoroscopy during implantation of the cardiac valve10. Alternatively, or in addition, all or a portion of each anchoring projection221, distal anchor projections18, and/or the first struts14, second struts15and/or biasing projections172may have a radiopaque material formed therein or thereupon as part of the vacuum deposition process to make the metal material hypotube. An example of selective deposition of radiopaque marker materials onto regions of a tubular hypotube is disclosed in co-pending, commonly assigned U.S. patent application Ser. No. 17/327,667 filed May 21, 2021, which is hereby incorporated by reference in its entirety.

FIG.13is a side elevational view of cardiac valve200without the polymer coating of covering250showing the petal-like shape of the valve leaflet portions224and the corresponding petal-like shape of the collective biasing projections217.FIG.14provides an enlarged view of a biased cell having biasing projections217and spring strut222. Each of the spring strut222and the biasing projections221have a width W2 and W1, respectively, that may be the same width or different widths. For example, a portion of the biasing projection217that extends from biased cell203may have a narrower or greater width W1 than a width W2 of the spring strut222.

FIG.15is a planar view of a one-third circumferential section of the lattice frame structure202for a tricuspid cardiac valve in accordance with an alternative embodiment of the cardiac valve200present invention. Lattice frame structure202, like lattice frame structure12described above, is composed of a plurality of first struts214, a plurality of second struts215, spring struts222, a plurality of biasing projections217, and anchor projections221. The plurality of the first struts214have a helical orientation in a first direction relative to the longitudinal and circumferential axes of the cardiac valve200and the plurality of second struts215have a helical orientation in a second direction relative to the longitudinal and circumferential axes of the cardiac valve200. The first direction and the second direction may be opposing or offset from one and other such that the first struts214and the second struts215intersect to form the biased cells203of the lattice frame structure202, as exemplified in detail inFIG.15.

Lattice frame structure12,202is made of a shape memory or superelastic metal material, such as, for example, binary, ternary, quaternary, or greater nickel-titanium based alloys. Alternatively, lattice frame structure202is made of a plastically deformable, e.g., balloon expandable metal material, where the spring struts222and biasing projections217are elastic. Examples of metal materials suitable for use in fabricating the lattice frame structure12,202are metal materials material is selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum, hafnium, tungsten, rhenium, iridium, bismuth, iron, and alloys thereof, for example, nickel-titanium, nickel-titanium-cobalt, nickel-titanium-chromium, zirconium-titanium-tantalum alloys, or stainless steel. The foregoing metal materials are suited for physical vapor deposition to form the metal hypotube and tolerate post-deposition laser cutting and electropolishing to form the lattice frame structure202.

The plurality of biasing projections217may originate at an apex of a biased cell203and project distally from a distal end of the valve leaflet portion224. Each of the plurality of biasing projections217are be in longitudinal alignment with a spring strut222and contiguous therewith. The plurality of biasing projections217each have a distal end206that may, optionally, terminate in a rounded end209configured to accept a radiopaque marker (not shown) coupled thereto. The plurality of biasing projections217, optionally, each have different lengths207such that the distal end206of the plurality of biasing projections217align to form a generally sinusoidal distal end of the cardiac valve200. This generally sinusoidal distal end of the cardiac valve200functions to support a polymer coating or covering250illustrated inFIG.16that forms the valve leaflets of the cardiac valve200.

Each of the plurality of biasing projections217may, optionally, have a tapered width that tapers to a relatively smaller width W2 distally that relatively larger width W1 at proximal aspects of each of the plurality of elongate members108that emanate from a first strut214or a second strut215at a terminal end of the lattice frame structure202. For example, W2 may be 0.06 mm whereas W2 may be 0.1 mm. Also optionally, the width of each of the plurality of biasing projections217may taper to a smaller width W3 where the spring strut222bisects a biased cell203. The length, width, and optional taper of each of the plurality of biasing projections217may be selected based upon the desired configuration of the valve leaflet configuration, the polymer selected for the coating or covering250, and the opening and closing pressures desired for the valve leaflets. Finally, the biasing projections217may have a taper along the build axis of the biasing projections217.

The plurality of anchoring projections221may, optionally, also be provided at one or both ends of the body portion225of the lattice frame structure. The plurality of anchoring projections221project proximally from the cardiac valve200and also bisect a proximal terminal end of the biased cell203. Like each of the biasing projections217, the anchoring projections221may, optionally, have a rounded end212configured to couple to a radiopaque marker (not shown).

In use, the cardiac valve10,200is collapsed to a smaller diametric profile and loaded into a restraining delivery tube of a delivery catheter. As noted above, the geometry of cardiac valve10and/or cardiac valve200allow for the smaller diametric profile to be loaded into a catheter having a 15 F inner diameter of less and 16 French outer diameter of less. Most preferably the delivery catheter will have a 13-15 French inner diameter (4.3 to 5 mm) and a 14-16 French outer diameter (4.67 to 5.3 mm). The deployed diameter of a cardiac valve10or cardiac valve200in the aorta will be between 30 mm or larger depending upon the patient. Therefore the single tubular design of the cardiac valve10,200has an 8-10 fold factor of diametric expansion.

It will be appreciated by those skilled in the art that selection of superelastic alloys with greater material properties that nitinol may also allow for PVD fabrication of the cardiac valves10,200that are capable of even smaller collapsed smaller diameters and allow for even smaller delivery catheter profiles.

As the cardiac valve10,200exits the restraining delivery tube, the lattice frame structure12,202will diametrically expand and the valve leaflet sections24will deform radially inward toward the central axis of the cardiac valve10,200all following a pre-determined heat-set configuration. The heat set configuration is the resting position of the valve leaflets and is induced by a bias imposed on polymer valve leaflets by the distal anchor projections18,208such that the free distal edges of the valve leaflets meet and abut in a commissure in the center of the cardiac valve10,200. Diametric expansion of the lattice frame structure12,202causes the circumferential expansion of the biased cells13,203. The spring struts22also limit a shortening effect induced by the circumferential expansion of the biased cells13,203.

It will be appreciated that a bicuspid, tricuspid or quadricuspid design of the cardiac valve10,200will require differing lengths of the anchoring projections18,221and the valve leaflet portions24,224. For example, since a quadricuspid design has four cusps, each cusp may have a relatively lesser length than a tricuspid or bicuspid valve design. Where a shorter length of each cusp is possible, the mechanical load on the anchoring projections18,221and the valve leaflet portions24,224will be reduced and the length and/or number of distal anchor projections18,208may be adjusted in view of a smaller load applied by the individual valve leaflets.

While the invention has been described with reference to its preferred embodiments, those of ordinary skill in the relevant arts will understand and appreciate that the present invention is not limited to the recited preferred embodiments, but that various modifications in material selection, deposition methodology, manner of controlling the grain formation within individual layers, across multiple layers, or throughout the entire thickness of the multi-layer material, and deposition process parameters may be employed without departing from the invention, which is to be limited only by the claims appended hereto.