Methods for improved prosthetic heart valve with leaflet shelving

Description

FIELD

The present disclosure relates generally to prosthetic valves and more specifically to synthetic flexible leaflet-type prosthetic valve devices, systems, and methods with controlled leaflet opening.

BACKGROUND

The durability of synthetic valve leaflets is partially a function of the character of bending by the leaflet during the opening-closing cycle. Small radius bends, creases and intersecting creases, can produce high stress zones in the leaflet. These high stress zones can cause the formation of holes and tears under repetitive loading.

Prosthetic valves may be delivered using surgical or transcatheter techniques. A surgical valve is implanted into a patient using open-heart surgical techniques. The surgical valve is usually manufactured to have a fixed diameter as opposed to a transcatheter valve which is required to attain a range of diameters for access and delivery. The surgical valve is usually provided with a sewing cuff about a perimeter of the valve to allow for suturing to the native tissue orifice. Sewing cuffs are well known in the art.

In addition to the valve durability issues discussed above, the transcatheter valve must also be able to withstand the handling and deployment stresses associated with being compressed and expanded

The shape most often described as preferable is modeled after the native human aortic valve. Though nature dictates the optimum shape for the native tissues to form a heart valve, we have discovered this is not true for synthetic materials; accordingly, the design specified in the current disclosure is instead intended to place the synthetic material under a minimized stress condition as compared to those based on copies of the native valve. This is partially accomplished through reduced buckling in the leaflet material.

There exists a need for a durable synthetic prosthetic valve that may be delivered either surgically or endovascularly.

SUMMARY

Described embodiments are directed to an apparatus, system, and methods for valve replacement, such as cardiac valve replacement. More specifically, described embodiments are directed toward flexible leaflet valve devices in which the base of each leaflet forms a straight line.

A prosthetic valve is provided comprising a leaflet frame and a plurality of leaflets coupled to the leaflet frame. Each leaflet includes a free edge and a leaflet base. Each leaflet has a planar zone in a central region, wherein the planar zone is substantially planar. The planar zone defines a shape having an area, wherein the area is larger nearer the base than the free edge. The leaflet is operable to bend about a straight base segment of the leaflet base in which the planar zone base of the planar zone of the leaflet is a straight line that has a length of less than C.

A method of forming a prosthetic heart valve, comprises: providing a leaflet frame having a generally tubular shape, the leaflet frame defining a plurality of leaflet windows wherein each of the leaflet windows includes two leaflet window sides, a leaflet window base, and a leaflet window top; providing a film; wrapping the film about the leaflet frame bringing more than one layer of the film into contact with additional layers of the film defining at least one leaflet extending from each of the leaflet windows; and bonding the layers of film to itself and to the leaflet frame, wherein each leaflet has substantially a shape of an isosceles trapezoid having two leaflet sides, a leaflet base and a free edge opposite the leaflet base, wherein the two leaflet sides diverge from the leaflet base, wherein the leaflet base is substantially flat, wherein the leaflet base is coupled to the window base and wherein each of the two leaflet sides are coupled to one of the two window sides providing a generally annular support structure, each leaflet having a planar zone in a central region, wherein the planar zone is substantially planar, wherein the planar zone defines a shape having an area, wherein the area is larger nearer the base than the free edge, wherein the leaflet is operable to bend about a straight base segment of the leaflet base in which the planar zone base of the planar zone of the leaflet is a straight line that has a length of less than C.

In some embodiments, particularly in the case of transcatheter valves, the leaflet frame is placed coaxially within an outer frame. In these embodiments the leaflet frame and the outer frame act in concert as the diameter is reduced for delivery, and then re-expanded at the recipient site.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments described herein, and together with the description serve to explain the principles discussed in this disclosure.

FIG. 1A is a side view of an embodiment of a valve;

FIG. 1B is a side view of the embodiment of the valve of FIG. 1A;

FIG. 1C is a perspective view of the embodiment of the valve of FIG. 1A;

FIG. 1D is a representation of a valve in an expanded configuration;

FIG. 1E is a representation of a valve in a compressed configuration;

FIG. 2A is a representation of the embodiment of the valve of FIG. 1A unrolled to a flat orientation;

FIG. 2B is an exploded representation of the embodiment of the valve of FIG. 1A unrolled to a flat orientation;

FIG. 3A is an axial or top view of the embodiment of the valve of FIG. 1A in an open configuration;

FIG. 3B is an axial or top view of the embodiment of the valve of FIG. 1A in a closed configuration;

FIG. 4A is a side view of an embodiment of a transcatheter delivery system within anatomy;

FIG. 4B is a side view of an embodiment of a surgical valve within anatomy;

FIG. 5A is a cross-sectional view of an embodiment of the valve during manufacture;

FIG. 5B is a cross-sectional view of an embodiment of the valve;

FIG. 6A is a representation of an embodiment of an outer frame unrolled to a flat orientation;

FIG. 6B is a representation of an embodiment of an outer frame unrolled to a flat orientation;

FIG. 7A is a representation of an embodiment of a leaflet frame unrolled to a flat orientation;

FIG. 7B is a representation of an embodiment of a leaflet frame unrolled to a flat orientation;

FIG. 8A is a representation of an embodiment of a leaflet frame unrolled to a flat orientation;

FIG. 8B is a representation of an embodiment of a leaflet frame unrolled to a flat orientation;

FIG. 8C is a representation of an embodiment of a leaflet frame unrolled to a flat orientation;

FIG. 8D is a representation of an embodiment of a leaflet frame unrolled to a flat orientation;

FIG. 8E is a representation of an embodiment of a leaflet frame unrolled to a flat orientation;

FIG. 8F is a representation of an embodiment of a leaflet frame unrolled to a flat orientation;

FIG. 9A is a side view of valve components on an assembly mandrel, in accordance with an embodiment;

FIG. 9B is a side view of valve components on an assembly mandrel, in accordance with an embodiment;

FIG. 10A is a side exploded view of a prosthetic valve comprising a leaflet frame having a generally tubular shape and an outer frame having a generally tubular shape that are coupled by a mechanic engagement member, in accordance with another embodiment;

FIG. 10B is an assembled view of the embodiment of FIG. 10A;

FIG. 11A is a side view of an embodiment of a valve;

FIG. 11B is a top view of the embodiment of the valve of FIG. 1A;

FIG. 12 is a side view of a leaflet frame on an assembly mandrel, in accordance with an embodiment;

FIG. 13A is a side view of the leaflet frame on a cutting mandrel, in accordance with an embodiment;

FIG. 13B is a perspective view of the leaflet frame on the cutting mandrel of FIG. 13A; and

FIGS. 14A and 14B are simplified top view representations of a heart valve having three leaflets, in closed and open positions, respectively.

DETAILED DESCRIPTION

Persons skilled in the art will readily appreciate that various aspects of the present disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. Stated differently, other methods and apparatuses can be incorporated herein to perform the intended functions. It should also be noted that the accompanying drawing figures referred to herein are not necessarily drawn to scale, but may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawing figures should not be construed as limiting.

Although the embodiments herein may be described in connection with various principles and beliefs, the described embodiments should not be bound by theory. For example, embodiments are described herein in connection with prosthetic valves, more specifically cardiac prosthetic valves. However, embodiments within the scope of this disclosure can be applied toward any valve or mechanism of similar structure and/or function. Furthermore, embodiments within the scope of this disclosure can be applied in non-cardiac applications.

The term leaflet as used herein in the context of prosthetic valves is a component of a one-way valve wherein the leaflet is operable to move between an open and closed position under the influence of a pressure differential. In an open position, the leaflet allows blood to flow through the valve. In a closed position, the leaflet substantially blocks retrograde flow through the valve. In embodiments comprising multiple leaflets, each leaflet cooperates with at least one neighboring leaflet to block the retrograde flow of blood. The pressure differential in the blood is caused, for example, by the contraction of a ventricle or atrium of the heart, such pressure differential typically resulting from a fluid pressure building up on one side of the leaflets when closed. As the pressure on an inflow side of the valve rises above the pressure on the outflow side of the valve, the leaflets opens and blood flows therethrough. As blood flows through the valve into a neighboring chamber or blood vessel, the pressure on the inflow side equalizes with the pressure on the outflow side. As the pressure on the outflow side of the valve raises above the blood pressure on the inflow side of the valve, the leaflet returns to the closed position generally preventing retrograde flow of blood through the valve.

The term membrane as used herein refers to a sheet of material comprising a single composition, such as, but not limited to, expanded fluoropolymer.

The term composite material as used herein refers to a combination of a membrane, such as, but not limited to, expanded fluoropolymer, and an elastomer, such as, but not limited to, a fluoroelastomer. The elastomer may be imbibed within a porous structure of the membrane, coated on one or both sides of the membrane, or a combination of coated on and imbibed within the membrane.

The term laminate as used herein refers to multiple layers of membrane, composite material, or other materials, such as elastomer, and combinations thereof.

The term film as used herein generically refers to one or more of the membrane, composite material, or laminate.

The term biocompatible material as used herein generically refers to a film or a biological material, such as, but not limited to, bovine pericardium.

The term leaflet window is defined as that space that a frame defines from which a leaflet extends. The leaflet may extend from frame elements or adjacent to frame elements and spaced apart therefrom.

The terms native valve orifice and tissue orifice refer to an anatomical structure into which a prosthetic valve may be placed. Such anatomical structure includes, but is not limited to, a location wherein a cardiac valve may or may not have been surgically removed. It is understood that other anatomical structures that may receive a prosthetic valve include, but are not limited to, veins, arteries, ducts and shunts. Although reference is made herein to replacing a native valve with a prosthetic valve, it is understood and appreciated that a valve orifice or implant site may also refer to a location in a synthetic or biological conduit that may receive a valve for a particular purpose, and therefore the scope of the embodiments provided herein is not limited to valve replacement.

As used herein, “couple” means to join, connect, attach, adhere, affix, or bond, whether directly or indirectly, and whether permanently or temporarily.

Embodiments herein include various apparatus, systems, and methods for a prosthetic valve suitable for surgical and transcatheter placement, such as, but not limited to, cardiac valve replacement. The valve is operable as a one-way valve wherein the valve defines a valve orifice into which leaflets open to permit flow and close so as to occlude the valve orifice and prevent flow in response to differential fluid pressure.

Embodiments provided herein are related to controlled leaflet opening. The durability of the valve leaflets is largely controlled by the character of bending exhibited by the leaflet during the opening-closing cycle. Small radius bends, creases and particularly intersecting creases, can produce high stress zones in the leaflet. These high stress zones can cause the formation of holes and tears under repetitive loading.

Controlled bending is of particular importance in thin, high-modulus synthetic leaflets, since the bending in these materials tends to be cellophane-like. If the leaflet bending character is uncontrolled, not only do creases form, but crease intersections lead to formation of large three dimensional structures that oppose bending and slow down the leaflet motion, both in opening and closing: in order to avoid this, the sequence of opening of the parts of the leaflet must be controlled.

In accordance with some embodiments presented herein, a prosthetic valve comprises two frames; a leaflet frame and an outer frame. The film that comprises the leaflet may be coupled to the inner surface of the leaflet frame. In some other embodiments, the film that comprises the leaflet is contained between the leaflet frame and the outer frame and extends through a leaflet window defined by the leaflet frame. The leaflet, therefore, is significantly prevented from peeling or delaminating as it is contained between the leaflet frame and outer frame, as compared to where the leaflets are only coupled to the inner surface of the leaflet frame.

In accordance with some embodiments presented herein, a prosthetic valve comprises two frames; a leaflet frame and an outer frame. The leaflet frame and the outer frame are separated from each other by a film. In other words, there is a metal to polymer to metal interconnection, wherein there is no metal to metal contact between the two frames.

In accordance with some embodiments presented herein, a prosthetic valve comprises two frames; a leaflet frame and an outer frame. The leaflet frame is nested within the outer frame, wherein the leaflet frame and outer frame cooperate to provide relatively high resistance to flat plate compression, among other things. In accordance with some embodiments, the outer frame provides frame elements that overlay the leaflet windows that are defined by the leaflet frame so as to provide structural support over the leaflet windows. In accordance with some embodiments, the outer frame provides frame elements that overlay the leaflet windows that are defined by the leaflet frame so as to prevent tissue from extending into the leaflet windows when implanted. In accordance with some embodiments, the outer frame provides frame elements that overlay the leaflet windows that are defined by the leaflet frame and act in concert so as to allow the frame assembly to compress and expand uniformly for transcatheter embodiments.

In accordance with some embodiments presented herein, a prosthetic valve comprises two frames; a leaflet frame and an outer frame. The leaflet frame defines leaflet windows that define, in part, the shape of the leaflets. In some embodiments the leaflet comprises a flat base, wherein the leaflet bends from the base towards the free edge with minimal creasing and fluttering. In accordance with embodiments, the leaflet comprises a flat base, that, among other things, provides for one or more of a shorter valve length, substantially prevents blood stagnation and pooling and encourages washing at the base, as compared to leaflets having a rounded base.

In accordance with some embodiments presented herein, a prosthetic valve comprises two frames; a leaflet frame and an outer frame. The leaflet frame defines leaflet windows from which the leaflets extend. The leaflets are defined by the intersection of films that form an overlapping zone so as to define, at least in part, the leaflet base and/or the leaflet sides.

Embodiments provided herein address controlled leaflet opening. The durability of the valve leaflets is largely controlled by the character of bending exhibited by the leaflet during the opening-closing cycle. Small radius bends, creases and particularly intersecting creases, can produce high stress zones in the leaflet. These high stress zones can cause the formation of holes and tears under repetitive loading. Embodiments provided herein provide a feature of leaflet shape so as to minimize crease formation, which is of particular importance in thin, high-modulus leaflets, since the bending in these materials tends to be cellophane-like. If the leaflet bending is unrestricted, not only do creases form, but crease intersections lead to formation of large three dimensional structures that oppose bending and slow down the leaflet motion, both in opening and closing.

Valve

FIGS. 14A and 14B are simplified top view representations of a valve 100 having three leaflets 140, in closed and open positions, respectively. The leaflets 140 have a free edge 142 and a leaflet base 143. The leaflet base 143 is defined, at least in part, by where the leaflet 140 bends when it is open.

In any trileaflet valve 100, each leaflet 140 occupies a segment 196 of a circle 195 defined by a leaflet frame 130, as shown in FIG. 3A. The valve 100 is symmetric so that angle θ is 120° and arc length S is ⅓ of the diameter of the circle 195.

In certain configurations bending of the leaflet 140 may occur along chord C. Chord C is defined as a straight line that extends from two commissure posts 132. Leaflet actuation in this case is rapid, but the total flow area is restricted to a small equilateral triangle with sides of length R providing less than optimal flow area leading to excessive restriction.

In certain other configurations, bending of the leaflet 140 may occur along arc length S, at least for high-modulus, thin materials, if bending of the leaflet base 143 occurs close to the leaflet frame 130 essentially along the circle 195. In such cases the closing action of the leaflet 140 is delayed when flow is reversed.

In accordance with embodiments provided herein, for optimum performance of the leaflet 140, it is appreciated herein that bending of the leaflet 140 adjacent the leaflet base 143 must be along a substantially straight line instead of an arc, but this straight line has a length that must be less than a length of chord C. This straight line is represented by a straight base segment 145 in FIG. 14A.

In embodiments of prosthetic valves 100 provided herein, each of the leaflets 140 comprises a leaflet base 143 having a flat portion 149 that defines a shelf structure, as shown in FIG. 14A. In operation, the leaflet 140 bends from the flat portion 149 along the straight base segment 145 of the leaflet base 143 towards the free edge 142 with minimal creasing and fluttering. The leaflet base 143 having a flat portion 149 provides, among other things, a shorter valve length, substantially prevents blood stagnation and pooling and encourages washing at the leaflet base 143, as compared to leaflets 140 having a rounded leaflet base 143. A leaflet base 143 that has a straight base segment 145 also provides a superior hemodynamic outcome during the closing phase of the valve.

In accordance with embodiments of the prosthetic valve 100 provided herein, a planar zone 192 of the leaflet 140 comprises a planar zone base 193 which is coincident with the straight base segment 145 which is a substantially straight line that has a length that is less than a length of chord C. This combination produces basal bending of the leaflet 140.

FIG. 1A is a side view of a valve 100, in accordance with an embodiment. FIG. 1B is also a side view of the valve 100 of FIG. 1A rotated 60 degrees about the longitudinal axis X. FIG. 1C is a perspective view of the valve 100 of FIG. 1A. FIG. 11A is a side view of another embodiment of a valve 100. FIG. 11B is a perspective view of the embodiment of the valve of FIG. 11A. FIGS. 3A and 3B are axial views of the valve 100 of FIG. 1A, in an open and closed configuration, respectively, which presents a configuration substantially the same as for the valve 100 of the embodiment of FIG. 11A. It is shown that bending of the leaflet 140 occurs at the leaflet base 143, a portion of which is along a straight base segment 145. In FIGS. 1C, 3B and 11B, the leaflets 140 are shown slightly open to better show the features but it is understood that a fully closed valve 100 will have the free edges 142 of the leaflets 140 coming together to coapt under the influence of downstream fluid pressure which results in closing the valve to prevent downstream blood from flowing retrograde through the valve.

FIG. 1A is a side view of a valve 100, in accordance with an embodiment. FIG. 1B is also a side view of the valve 100 of FIG. 1A rotated 60 degrees about the longitudinal axis X. FIG. 1C is a perspective view of the valve 100 of FIG. 1A. FIG. 2A is a side view of the valve 100 of FIG. 1A wherein the valve 100 has been longitudinally cut and laid open to better illustrate the elements of the generally tubular-shaped valve 100. FIG. 2B is an exploded view of the embodiment of FIG. 2A. FIGS. 3A and 3B are axial views of the valve 100 of FIG. 1A in an open and closed configuration, respectively. The valve 100 of the embodiment of FIG. 1A is suitable for surgical or transcatheter delivery and deployment. As will be explained below, the valve 100 is operable to be reduced in diameter for transcatheter delivery and radially expanded for deployment.

Referring again to the embodiment of the valve 100 of FIG. 1A, the valve 100 comprises an outer frame 120, a leaflet frame 130, and a film 160 covering the outer frame 120 and leaflet frame 130, coupling the outer frame 120 to the leaflet frame 130, and defining leaflets 140. The embodiment of valve 100 is discussed further related to a transcatheter valve that may be compressed and re-expanded. It is understood that the embodiment of valve 100 is also applicable to a surgical valve by the addition of a sewing cuff 171 as shown in FIG. 4B. Leaflet frame and outer frame configurations related to surgical valve only embodiments where the valves have a fixed diameter, will be discussed in other embodiments later in this disclosure.

FIG. 11A is a side view of another embodiment of a valve 100. FIG. 11B is a perspective view of the embodiment of the valve of FIG. 11A. The valve 100 of the embodiment of FIG. 11A is suitable for surgical placement. As will be explained below, the valve 100 is operable to retain a predetermined diameter that resists radial compression or expansion. Referring again to the embodiment of the valve 100 of FIG. 11A, the valve 100 comprises a leaflet frame 130, and a film 160 covering the leaflet frame 130 and defining leaflets 140.

The embodiments of the valve 100 of FIGS. 1A and 11A are provided as non-limiting examples to show that the concepts presented herein related to leaflets with straight line basal bending about a straight base segment of the leaflet in which the planar zone base of the planar zone of the leaflet is a line of length less than chord C, may be applied to prosthetic heart valves of many configurations and designs.

Outer Frame

The embodiment of the valve 100 of FIG. 1A comprises a leaflet frame 130 and an outer frame 120. The outer frame 120 is a generally tubular member defining a generally open pattern of apertures 122, in accordance with an embodiment. In accordance with transcatheter embodiments, the outer frame 120 is operable to allow the outer frame 120 to be compressed and expanded between different diameters. The outer frame 120 comprises an outer frame first end 121a and an outer frame second end 121b opposite the outer frame first end 121a. The outer frame 120 comprises an outer frame outer surface 126a and an outer frame inner surface 126b opposite the outer frame outer surface 126a, as shown in FIG. 5A. The outer frame 120 may comprise a structure known in the art as a stent. A stent is a tubular member that may have a small diameter suitable for percutaneous transcatheter delivery into the anatomy, and may be expanded to a larger diameter when deployed into the anatomy. Stents having various designs and material properties are well known in the art.

By way of example, and as illustrated in the embodiments of FIGS. 1A-1C and 2A-2B, the valve 100 includes the outer frame 120 that defines a stent having apertures 122 having generally a diamond shape when in a large diameter configuration, as shown generally in FIG. 1D. Upon compression to a smaller diameter, the apertures 122 deform to generally define an elongated diamond shape, as shown generally in FIG. 1E. Upon re-expansion to a larger diameter, the apertures 122 re-expand to again define a generally diamond shape.

FIGS. 6A and 6B are side views of alternative embodiments of the outer frame 120a, 120b wherein the outer frame has been longitudinally cut and laid open to better illustrate the elements of the outer frame. It is appreciated that there are many embodiments of the outer frame having configurations suitable for the particular purpose.

An open framework of the stent can define any number of features, repeatable or otherwise, such as geometric shapes and/or linear or meandering series of sinusoids. Geometric shapes can comprise any shape that facilitates substantially uniform circumferential compression and expansion. The outer frame 120 may comprise a cut tube, or any other element suitable for the particular purpose. The outer frame 120 may be etched, cut, laser cut, or stamped into a tube or a sheet of material, with the sheet then formed into a substantially cylindrical structure. Alternatively, an elongated material, such as a wire, bendable strip, or a series thereof, can be bent or braided and formed into a substantially cylindrical structure wherein the walls of the cylinder comprise an open framework that is compressible to a smaller diameter in a generally uniform and circumferential manner and expandable to a larger diameter.

It is known that stents of various designs may be elastically deformable so as to be self-expanding under spring loads. It is also known that stents of various designs may be plastically deformable so as to be mechanically expanded such as with a balloon. It is also known that stents of various designs may be plastically deformable as well as elastically deformable. The embodiments of the outer frame 120 presented herein are not to be limited to a specific stent design or mode of expansion.

The outer frame 120 can comprise any metallic or polymeric biocompatible material. For example, the outer frame 120 can comprise a material, such as, but not limited to nitinol, cobalt-nickel alloy, stainless steel, or polypropylene, acetyl homopolymer, acetyl copolymer, ePTFE, other alloys or polymers, or any other biocompatible material having adequate physical and mechanical properties to function as described herein.

In accordance with embodiments, the outer frame 120 and/or leaflet frame 130 can be configured to provide positive engagement with an implant site to firmly anchor the valve 100 to the site, as shown in FIG. 4A representing a transcatheter deployment of the valve 100. In accordance with an embodiment, the outer frame 120 can comprise a sufficiently rigid frame having small elastic recoil so as to maintain sufficient apposition against a tissue orifice 150 to maintain position. In accordance with another embodiment, the outer frame 120 and/or leaflet frame 130 can be configured to expand to a diameter that is larger than a tissue orifice 150 so that when valve 100 expands into the tissue orifice 150, it can be firmly seated therein. In accordance with another embodiment, the outer frame 120 can comprise one or more anchors (not shown) configured to engage the implant site, such as a tissue orifice 150, to secure the valve 100 to the implant site.

It is appreciated that other elements or means for coupling the valve 100 to an implant site are anticipated. By way of example, but not limited thereto, other means, such as mechanical and adhesive means may be used to couple the valve 100 to a synthetic or biological conduit.

Sewing Cuff

In accordance with a surgical valve 100 embodiment, the valve 100 further comprises a sewing cuff 171 about an outer frame outer surface 127 in accordance with an embodiment, as shown in FIG. 4B, or about the leaflet frame 130 in embodiments where there is not outer frame 120. The sewing cuff 171 is operable to provide structure that receives suture for coupling to the implant site. The sewing cuff 171 may comprise any suitable material, such as, but not limited to, double velour polyester. The sewing cuff 171 may be located circumferentially around a perimeter of the outer frame 120 or the leaflet frame 130 if there is no outer frame 120. Sewing cuffs 171 are known in the art.

Leaflet Frame

Referring again to FIGS. 1C and 2B, the leaflet frame 130 of the embodiment of FIG. 1C, is a generally tubular member defining a plurality of leaflet windows 137 coupled together by connecting elements 139, in accordance with an embodiment. The leaflet frame 130 comprises a leaflet frame first end 138a and a leaflet frame second end 138b opposite the leaflet frame first end 138a. The leaflet frame 130 comprises a leaflet frame outer surface 132a and a leaflet frame inner surface 132b opposite the leaflet frame outer surface 132a, as shown in FIG. 5A. The leaflet frame first end 138a and the leaflet frame second end 138b define a generally zigzag configuration to facilitate flexion about flex points 136 such as which facilitates compression and expansion between different diameters for compression onto a delivery device and expansion by a balloon for the transcatheter valve 100 embodiments, as generally explained for the outer frame 120. As will be discussed later, the surgical valve 100 embodiment may or may not have the zigzag configuration since the surgical valve 100 may be of a fixed diameter and need not be operable to compress and re-expand.

The leaflet frame 130 may be referred to in a general sense as a stent or a frame.

The leaflet frame 130 defines a predetermined repeating pattern as shown in FIG. 2B, in accordance with an embodiment. The leaflet frame 130 defines three interconnected leaflet windows 137 having a substantially triangular shape. Each of the leaflet windows 137 includes two leaflet window sides 133 including commissure posts 132, a leaflet window base 134, and a leaflet window top 135. In this embodiment, the leaflet window base 134 defines a flex point 136 which will be described further below. A leaflet window side 133 and leaflet window top 135 of one leaflet window 137 is interconnected with a leaflet window side 133 of an adjacent leaflet window 137 at the commissure posts 132.

The leaflet frame 130 defines any number of features and geometric shapes that facilitate substantially uniform circumferential compression and expansion. The leaflet frame 130 may comprise a cut tube, or any other element suitable for the particular purpose. The leaflet frame 130 may be etched, cut, laser cut, or stamped into a tube or a sheet of material, with the sheet then formed into a substantially cylindrical structure. Alternatively, an elongated material, such as a wire, bendable strip, or a series thereof, can be bent or braided and formed into a substantially cylindrical structure wherein the walls of the cylinder comprise an open framework that is compressible to a smaller diameter in a generally uniform and circumferential manner and expandable to a larger diameter.

The leaflet frame 130 can comprise any metallic or polymeric biocompatible material. For example, the leaflet frame 130 can comprise a material, such as, but not limited to nitinol, cobalt-nickel alloy, stainless steel, or polypropylene, acetyl homopolymer, acetyl copolymer, ePTFE, other alloys or polymers, or any other biocompatible material having adequate physical and mechanical properties to function as described herein.

As will be described in more detail below, a film 160 is disposed over each of the three leaflet windows 137 to form a leaflet 140. Further embodiments will be described below wherein the leaflet window 137 defines shapes other than a substantially triangular shape, including, but not limited to a parabolic shape and a trapezoidal shape, with and without a leaflet window top 135, suitable for a particular purpose of an embodiment of a surgical and transcatheter valve 100.

FIGS. 7A and 7B are side views of alternative embodiments of the leaflet frame 130a, 130b wherein the leaflet frame has been longitudinally cut and laid open to better illustrate the elements of the leaflet frame. The leaflet frame 130a includes leaflet windows 137a having a substantially triangular shape defining a pointed leaflet window base 134a. The leaflet frame 130b includes leaflet windows 137b having a substantially triangular shape defining a flat leaflet window base 134b. The flat leaflet window base 134b may be used to define the leaflet base.

FIGS. 8A-8C are side views of alternative embodiments of the leaflet frame 130c-130e wherein the leaflet frame has been longitudinally cut and laid open to better illustrate the elements of the leaflet frame. The leaflet frame 130c includes leaflet windows 137c having a substantially triangular shape defining a pointed leaflet window base 134c. The leaflet frame 130d includes leaflet windows 137d having a substantially parabolic shape defining a rounded leaflet window base 134d. The flat leaflet window base 134b may be used to define the leaflet base. The leaflet frame 130e includes leaflet windows 137e having a substantially triangular shape defining a pointed leaflet window base 134e but not having a leaflet window top.

FIG. 8D is a side view of an alternative embodiment of the leaflet frame 130f wherein the leaflet frame 130f has been longitudinally cut and laid open to better illustrate the elements of the leaflet frame. The leaflet frame 130f includes leaflet windows 137f having a substantially isosceles trapezoid shape defining a flat leaflet window base 134f. The flat leaflet window base 134f may be used to define the leaflet base. A leaflet 140f is shown in dashed line to represent where the leaflet 143f is located within the leaflet window 137f, the leaflet window 137f being defined by the leaflet window sides 133f and the leaflet window base 134f. In accordance with other embodiments of the prosthetic valve, each leaflet 140f has substantially the shape of an isosceles trapezoid having two leaflet sides 141f, a leaflet base 143f and a free edge 142f opposite the leaflet base 143f, wherein the two leaflet sides 141f diverge from the leaflet base 143f, wherein the leaflet base 143f is substantially flat, as shown in dashed lines in FIG. 8D. The leaflet frame 130f further comprises extension elements 1121 that may be used to provide additional coaptation of the leaflet free edges.

FIG. 8E is a side view of an alternative embodiment of the leaflet frame 130g wherein the leaflet frame 130g has been longitudinally cut and laid open to better illustrate the elements of the leaflet frame. The leaflet frame 130g includes leaflet windows 137g having a substantially isosceles trapezoid shape defining a flat leaflet window base 134f. The flat leaflet window base 134g may be used to define the leaflet base. A leaflet 140g is shown in dashed line to represent where the leaflet 140g is located within the leaflet window 137g. In accordance with other embodiments of the prosthetic valve, each leaflet 140g has substantially the shape of an isosceles trapezoid having two leaflet sides 141g, a leaflet base 142g and a free edge 143g opposite the leaflet base, wherein the two leaflet sides 141g diverge from the leaflet base 143f, wherein the leaflet base 143f is substantially flat, as shown in dashed lines in FIG. 8E.

FIG. 8F is a side view of an alternative embodiment of the leaflet frame 130h wherein the leaflet frame 130h has been longitudinally cut and laid open to better illustrate the elements of the leaflet frame 130h. The leaflet frame 130h comprises a base element 138h and a plurality of spaced apart spade elements 170 interconnected by the base element 138h. Each leaflet window 137h is defined by a spade side 175 of one spade element 170 and a side 175 of an adjacent spade element 170, and wherein each leaflet window base 134h is defined by the base element 138h. In accordance with an embodiment of the prosthetic valve, each leaflet 140h has substantially the shape of an isosceles trapezoid having two leaflet sides 141h, a leaflet base 142h and a free edge 143h opposite the leaflet base 142h, wherein the two leaflet sides 141h diverge from the leaflet base 142h, wherein the leaflet base 142h is substantially flat, as shown in dashed lines in FIG. 8F. It is noted that at least a portion of the leaflet side 141h is supported by the leaflet frame 130h at the spade side 175 and at least a portion of the leaflet side 141h between the spade side 175 and the leaflet window base 134h is not supported by the leaflet frame 130h.

As previously discussed, the leaflet window base may be used to define the leaflet base in accordance with embodiments. Also as previously discussed, the leaflet base may be defined as a virtual leaflet base 1033 by a fold line 147 in the film 160 spaced apart from the leaflet window base 134, as shown in FIG. 2B. It is appreciated that there are many embodiments of the outer frame 120 having configurations suitable for the particular purpose.

In valve 100 embodiments suitable for transcatheter placement, the leaflet frame 130 is elastically, plastically, or both, compressible to obtain a relatively small diameter to accommodate percutaneous transcatheter mounting and delivery. In accordance with an embodiment as shown in FIG. 2B, the leaflet frame 130 may comprise one or more flex points 136 so as to provide a preferential flexing location for the leaflet frame 130 to flex when compressed to a smaller diameter. A flex point 136 comprises a site on the leaflet frame 130 that undergoes the highest degree of bending when transitioning from an expanded state to collapsed state and vice versa. The flex point 136 can comprise a geometry, structural modification or material modification, among others, that biases the leaflet frame 130 to bend at the flex point 136 when compressed.

The leaflet frame 130 may comprise, such as, but not limited to, any elastically deformable metallic or polymeric biocompatible material, in accordance with embodiments. The leaflet frame 130 may comprise a shape-memory material, such as nitinol, a nickel-titanium alloy. Other materials suitable for the leaflet frame 130 include, but are not limited to, other titanium alloys, stainless steel, cobalt-nickel alloy, polypropylene, acetyl homopolymer, acetyl copolymer, other alloys or polymers, or any other biocompatible material having adequate physical and mechanical properties to function as a leaflet frame 130 as described herein.

In accordance with an embodiment, the leaflet frame 130 and the outer frame 120 comprise a shape memory material operable to flex under load and retain its original shape when the load is removed, thus allowing the leaflet frame 130 and the outer frame 120 to self-expand from a compressed shape to a predetermined shape. The leaflet frame 130 and the outer frame 120 may comprise the same or different materials. In accordance with an embodiment, the leaflet frame 130 and the outer frame 120 are plastically deformable to be expanded by a balloon. In another embodiment the outer frame 120 and the leaflet frame 130 are elastically deformable so as to be self-expanding.

Film

The film 160 is generally any sheet-like material that is biologically compatible and configured to couple to the outer frame 120 and the leaflet frame 130, in accordance with embodiments. It is understood that the term “film” is used generically for one or more biocompatible materials suitable for a particular purpose. The leaflets 140 are also comprised of the film 160.

In accordance with an embodiment, the biocompatible material is a film 160 that is not of a biological source and that is sufficiently flexible and strong for the particular purpose, such as a biocompatible polymer. In an embodiment, the film 160 comprises a biocompatible polymer that is combined with an elastomer, referred to as a composite.

It is also understood that the film 160 coupled to the outer frame 120 may not be the same film 160 coupled to the leaflet frame 130, in accordance with embodiments. Details of various types of film 160 are discussed below. In an embodiment, the film 160 may be formed from a generally tubular material to at least partially cover the outer frame 120 and the leaflet frame 130. The film 160 can comprise one or more of a membrane, composite material, or laminate. Details of various types of film 160 are discussed below.

In an embodiment, the film 160 comprises a biocompatible polymer that is combined with an elastomer, referred to as a composite. A material according to one embodiment includes a composite material comprising an expanded fluoropolymer membrane, which comprises a plurality of spaces within a matrix of fibrils, and an elastomeric material. It should be appreciated that multiple types of fluoropolymer membranes and multiple types of elastomeric materials can be combined to form a laminate while remaining within the scope of the present disclosure. It should also be appreciated that the elastomeric material can include multiple elastomers, multiple types of non-elastomeric components, such as inorganic fillers, therapeutic agents, radiopaque markers, and the like while remaining within the scope of the present disclosure.

In accordance with an embodiment, the composite material includes an expanded fluoropolymer material made from porous ePTFE membrane, for instance as generally described in U.S. Pat. No. 7,306,729 to Bacino.

The expandable fluoropolymer, used to form the expanded fluoropolymer material described, may comprise PTFE homopolymer. In alternative embodiments, blends of PTFE, expandable modified PTFE and/or expanded copolymers of PTFE may be used. Non-limiting examples of suitable fluoropolymer materials are described in, for example, U.S. Pat. No. 5,708,044, to Branca, U.S. Pat. No. 6,541,589, to Baillie, U.S. Pat. No. 7,531,611, to Sabol et al., U.S. patent application Ser. No. 11/906,877, to Ford, and U.S. patent application Ser. No. 12/410,050, to Xu et al.

The expanded fluoropolymer membrane can comprise any suitable microstructure for achieving the desired leaflet performance. In accordance with an embodiment, the expanded fluoropolymer comprises a microstructure of nodes interconnected by fibrils, such as described in U.S. Pat. No. 3,953,566 to Gore. The fibrils radially extend from the nodes in a plurality of directions, and the membrane has a generally homogeneous structure. Membranes having this microstructure may typically exhibit a ratio of matrix tensile strength in two orthogonal directions of less than 2, and possibly less than 1.5.

In another embodiment, the expanded fluoropolymer membrane has a microstructure of substantially only fibrils, as is generally taught by U.S. Pat. No. 7,306,729, to Bacino. The expanded fluoropolymer membrane having substantially only fibrils, can possess a high surface area, such as greater than 20 m²/g, or greater than 25 m²/g, and in some embodiments can provide a highly balanced strength material having a product of matrix tensile strengths in two orthogonal directions of at least 1.5×10⁵MPa², and/or a ratio of matrix tensile strengths in two orthogonal directions of less than 4, and possibly less than 1.5.

The expanded fluoropolymer membrane can be tailored to have any suitable thickness and mass to achieve the desired leaflet performance. By way of example, but not limited thereto, the leaflet 140 comprises an expanded fluoropolymer membrane having a thickness of about 0.1 μm. The expanded fluoropolymer membrane can possess a mass per area of about 1.15 g/m². Membranes according to an embodiment of the invention can have matrix tensile strengths of about 411 MPa in the longitudinal direction and 315 MPa in the transverse direction.

Additional materials may be incorporated into the pores or within the material of the membranes or in between layers of membranes to enhance desired properties of the leaflet. Composite materials described herein can be tailored to have any suitable thickness and mass to achieve the desired leaflet performance. Composite materials according to embodiments can include fluoropolymer membranes and have a thickness of about 1.9 μm and a mass per area of about 4.1 g/m².

The expanded fluoropolymer membrane combined with elastomer to form a composite material provides the elements of the present disclosure with the performance attributes required for use in high-cycle flexural implant applications, such as heart valve leaflets, in various ways. For example, the addition of the elastomer can improve the fatigue performance of the leaflet by eliminating or reducing the stiffening observed with ePTFE-only materials. In addition, it may reduce the likelihood that the material will undergo permanent set deformation, such as wrinkling or creasing, that could result in compromised performance. In one embodiment, the elastomer occupies substantially all of the pore volume or space within the porous structure of the expanded fluoropolymer membrane. In another embodiment the elastomer is present in substantially all of the pores of the at least one fluoropolymer layer. Having elastomer filling the pore volume or present in substantially all of the pores reduces the space in which foreign materials can be undesirably incorporated into the composite. An example of such foreign material is calcium that may be drawn into the membrane from contact with the blood. If calcium becomes incorporated into the composite material, as used in a heart valve leaflet, for example, mechanical damage can occur during cycling open and closed, thus leading to the formation of holes in the leaflet and degradation in hemodynamics.

In an embodiment, the elastomer that is combined with the ePTFE is a thermoplastic copolymer of tetrafluoroethylene (TFE) and perfluoromethyl vinyl ether (PMVE), such as described in U.S. Pat. No. 7,462,675 to Chang et al. As discussed above, the elastomer is combined with the expanded fluoropolymer membrane such that the elastomer occupies substantially all of the void space or pores within the expanded fluoropolymer membrane to form a composite material. This filling of the pores of the expanded fluoropolymer membrane with elastomer can be performed by a variety of methods. In one embodiment, a method of filling the pores of the expanded fluoropolymer membrane includes the steps of dissolving the elastomer in a solvent suitable to create a solution with a viscosity and surface tension that is appropriate to partially or fully flow into the pores of the expanded fluoropolymer membrane and allow the solvent to evaporate, leaving the filler behind.

In one embodiment, the composite material comprises three layers: two outer layers of ePTFE and an inner layer of a fluoroelastomer disposed therebetween. Additional fluoroelastomers can be suitable and are described in U.S. Publication No. 2004/0024448 to Chang et al.

In another embodiment, a method of filling the pores of the expanded fluoropolymer membrane includes the steps of delivering the filler via a dispersion to partially or fully fill the pores of the expanded fluoropolymer membrane.

In another embodiment, a method of filling the pores of the expanded fluoropolymer membrane includes the steps of bringing the porous expanded fluoropolymer membrane into contact with a sheet of the elastomer under conditions of heat and/or pressure that allow elastomer to flow into the pores of the expanded fluoropolymer membrane.

In another embodiment, a method of filling the pores of the expanded fluoropolymer membrane includes the steps of polymerizing the elastomer within the pores of the expanded fluoropolymer membrane by first filling the pores with a prepolymer of the elastomer and then at least partially curing the elastomer.

After reaching a minimum percent by weight of elastomer, the leaflets constructed from fluoropolymer materials or ePTFE generally performed better with increasing percentages of elastomer resulting in significantly increased cycle lives. In one embodiment, the elastomer combined with the ePTFE is a thermoplastic copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether, such as described in U.S. Pat. No. 7,462,675 to Chang et al., and other references that would be known to those of skill in the art. Other biocompatible polymers which can be suitable for use in leaflet 140 include but are not limited to the groups of urethanes, silicones(organopolysiloxanes), copolymers of silicon-urethane, styrene/isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers and copolymers or mixtures of each of the foregoing.

Leaflet

Each leaflet window 137 is provided with a biocompatible material, such as a film 160, which is coupled to a portion of the leaflet window sides 133 with the film 160 defining a leaflet 140. Each leaflet 140 defines a free edge 142 and a leaflet base 143, in accordance with an embodiment. As will be described below, it is anticipated that a plurality of embodiments of leaflet base configurations may be provided. In accordance with an embodiment, the film 160 is coupled to a portion of the leaflet window sides 133 and to the leaflet window base 134 where the leaflet 140 is defined by the portion of the leaflet window sides 133 and to the leaflet window base 134. In accordance with another embodiment, the film 160 is coupled to a portion of the leaflet window sides 133 but not the leaflet window base 134 of the leaflet frame 130 where the leaflet 140 is defined by the portion of the leaflet window sides 133 and to a virtual leaflet base 1033 defined in a fold region as will be described below.

The shape of the leaflets 140 are defined in part by the shape of the leaflet window 137 and the free edge 142. As will be discussed below in accordance with an embodiment, the shape of the leaflets 140 also depends in part on a process that induces a fold at the fold line 147 to define a virtual leaflet base 1033 as will be described further below, so as to impart a predetermined shape to the leaflet 140. Since high bending stresses are located at the leaflet base, defining a virtual leaflet base 1033 that is not bound by the leaflet window base 134 may reduce the chance of tearing of the leaflet 140 at the leaflet base 143—leaflet window base 134 interface. It may also reduce blood pooling and stagnation at the leaflet base as compared with a rounded leaflet base.

In accordance with an embodiment, substantially the entire leaflet frame 130 lies adjacent to the outer frame inner surface 129, as shown in FIG. 3A. As such, when the leaflets 140 are in a fully open position, the valve 100 presents a substantially circular valve orifice 102 as shown in FIG. 3A. Fluid flow is permitted through the valve orifice 102 when the leaflets 140 are in an open position.

As the leaflets 140 cycle between the open and closed positions, the leaflets 140 generally flex about the leaflet base 143 and the portion of the leaflet window sides 133 to which the leaflet are coupled. When the valve 100 is closed, generally about half of each free edge 142 abuts an adjacent half of a free edge 142 of an adjacent leaflet 140, as shown in FIG. 3B. The three leaflets 140 of the embodiment of FIG. 3B meet at a triple point 148. The valve orifice 102 is occluded when the leaflets 140 are in the closed position stopping fluid flow.

Referring to FIG. 3B, in accordance with an embodiment, each leaflet 140 includes a central region 182 and two side regions 184 on opposite sides of the central region 182. The central region 182 is defined by a shape substantially that of an isosceles triangle defined by two central region sides 183, the leaflet base 143 and the free edge 142. The two central region sides 183 converge from the leaflet base 143 to the free edge 142. Each of the side regions 184 have a shape substantially that of a triangle and each are defined by one of the central region sides 183, one of the leaflet sides 141, and the free edge 142.

In accordance with an embodiment, each of the two side regions 184 and the central region 182 are substantially planar when the valve 100 is in the closed position.

The leaflet 140 can be configured to actuate at a pressure differential in the blood caused, for example, by the contraction of a ventricle or atrium of the heart, such pressure differential typically resulting from a fluid pressure building up on one side of the valve 100 when closed. As the pressure on an inflow side of the valve 100 rises above the pressure on the outflow side of the valve 100, the leaflet 140 opens and blood flows therethrough. As blood flows through the valve 100 into a neighboring chamber or blood vessel, the pressure equalizes. As the pressure on the outflow side of the valve 100 rises above the blood pressure on the inflow side of the valve 100, the leaflet 140 returns to the closed position generally preventing the retrograde flow of blood through the inflow side of the valve 100.

It is understood that the leaflet frame 130 may comprise any number of leaflet windows 137, and thus leaflets 140, suitable for a particular purpose, in accordance with embodiments. Leaflet frames 130 comprising one, two, three or more leaflet windows 137 and corresponding leaflets 140 are anticipated.

In accordance with embodiments, and referring to FIGS. 3B and 11A, the central region 182 is substantially planar, defining a planar zone, when the valve 100 is in the closed position and not under fluid pressure. The planar zone has a shape substantially of an isosceles triangle with apices extending to the leaflet frame 130. Referring to FIG. 1D, an apex line La is indicated connecting the apices 147 of the leaflets 140. The apex line La divides the leaflet 140 into a first region 149a adjacent the leaflet frame 130, and a second region 149b adjacent the free edge 142. The first region 149a contains a larger proportion of planar zone 192 than the second region 149b. In other embodiments, the majority of the planar zone 192 of each leaflet 140 is located inferior and exterior to apex line La joining the apices of two adjacent commissure posts 132. The ratio of area of the planar zone 192 distributed in the first region 149a and second region 149b has been found produce better leaflet opening dynamics than if there were more area of the planar zone 192 distributed in the second region 149b than the first region 149a.

As shown in the exploded unwrapped view of FIG. 2B of the embodiment of FIG. 2A, the outer frame 120 is located substantially coplanar, laterally adjacent to and spaced apart from the leaflet frame 130. The leaflet window base 134 of the leaflet window 137 is located proximate to an outer frame first end 121a of the outer frame 120 with the leaflet frame first end 138a of the leaflet frame 130 extending away from the outer frame 120. This placement is also used in the manufacture of the valve 100 as will be discussed below. While in this placement, the film 160 is coupled to the outer frame 120 and a portion of the leaflet frame 130 which couples the outer frame 120 to the leaflet frame 130.

The film 160 that spans the space between the outer frame 120 and the leaflet frame 130 defines at least in part a fold region 144. As will be discussed further below, in accordance with an embodiment, the fold region 144 is provided to allow the leaflet frame 130 to be telescopically disposed within the outer frame 120, the outer frame 120 having an inner diameter that is larger than the outer diameter of the leaflet frame 130, in accordance with an embodiment of a method of making the valve 100, hence creating a fold within the fold region 144 along a generally circumferential line 146.

It is anticipated that the film 160 may be coupled to the leaflet frame 130 and the outer frame 120 in many ways suitable for a particular purpose, in accordance with embodiments. In accordance with an embodiment, the outer frame 120 may be wrapped with overlapping layers of a film 160 having a first composition. The leaflet frame 130 may be wrapped with overlapping layers of a film 160 having a second composition. The wrapped leaflet frame 130, the wrapped outer frame 120, and the space between the outer frame 120 and the leaflet frame 130 may be wrapped with overlapping layers of a film 160 having a third composition defining, at least in part, the fold region 144.

In another embodiment, the film 160 may be coupled to the inner or outer surface of the leaflet frame 130 and outer frame 120. In another embodiment, the film 160 may be coupled to the inner and outer surface of the leaflet frame 130 and outer frame 120 sandwiching the leaflet frame 130 and outer frame 120 between the film 160. As will be discussed below, coupling the film 160 to at least the leaflet frame outer surface 132a and the outer frame inner surface 126b, as shown in FIGS. 5A-5B may provide additional support to the leaflet 140 to prevent disengagement of the leaflet 140 from the leaflet frame 130 since a portion of the film 160 is contained between the leaflet frame 130 and the outer frame 120, as shown in FIG. 5B.

Wherever the film 160 is present it prevents blood from traveling through or across the valve 100 other than through the valve orifice 102 when the leaflets 140 are in an open position and uncovered portions of the leaflet frame 130 or outer frame 120. As such, the film 160 creates a barrier to blood flow in any interstitial space(s) or apertures 122 of the outer frame 120 and leaflet frame 130, and therebetween, that the film 160 covers.

The film 160 is fixedly secured or otherwise coupled at a single or a plurality of locations of the inner surface or outer surface of the outer frame 120 and leaflet frame 130, for example, using one or more of taping, heat shrinking, adhesion and other processes known in the art. In some embodiments, a plurality of membrane/composite layers, i.e., a laminate, are used and can be coupled to both the inner and outer surfaces of the outer frame 120 and the leaflet frame 130 to form at least a portion of the film 160.

The film 160 comprises any material(s) that have the suitable physical and mechanical properties to perform the functions described herein. The film 160 may comprise the same material that the leaflet 140 comprises or a different material. Similarly, the film 160 may or may not be homogenous in material composition. Different portions of the film 160 can comprise different materials which can give it different physical and mechanical properties.

As previously discussed, in an embodiment of a method of making the valve 100, the leaflet frame 130 is disposed within the outer frame 120 in a telescoping manner whereby folding the film 160 in the fold region 144, as shown in FIGS. 5A-5B. The leaflet frame 130 is therefore nested within the outer frame 120 while remaining coaxial therewith. The assembly is further processed to couple the fold region 144 to itself and to the wrapped leaflet frame 130 and outer frame 120 while preventing the film 160 defining the leaflets 140 from adhering to unintended parts of the valve 100 that would prevent leaflet function.

In accordance with another embodiment, the frame members defining the apertures of the leaflet frame 130 and outer frame 120 are preferentially aligned to provide overlapping and complimentary arrangement so as to proved structural rigidity to the assembly.

In accordance with an embodiment of a transcatheter valve 100, with reference to FIGS. 1D-1E, the valve 100 may be compressed into a collapsed configuration having a smaller diameter and expanded into an expanded configuration so that the valve 100 can be endovascularly delivered in the collapsed configuration and expanded upon deployment within the tissue orifice 150 as shown in FIG. 4. The leaflet frame 130 and the outer frame 120 can be operable to recover circumferential uniformity when transitioning from the collapsed configuration to the expanded configuration.

The valve 100 may be mounted onto a delivery catheter, suitable for a particular purpose. The diameter of the valve 100 in the collapsed configuration is determined in part by the thickness of the leaflet frame 130 within the outer frame 120 and the leaflet thickness.

Other Considerations

FIGS. 10A and 10B are side exploded and assembled views, respectively, of a prosthetic valve 1000 comprising a leaflet frame 1130 having a generally tubular shape and an outer frame 1120 having a generally tubular shape that are coupled by a mechanic engagement member 1110, in accordance with another embodiment. The leaflet frame 1130 comprises an engagement member 1110 operable to engage the outer frame 1120 to affect coupling in which the leaflet frame 1130 is nested into the outer frame 1120 in a telescoping manner. The leaflet frame 1130 defines a plurality of leaflet windows 137, wherein film defines a leaflet extending from each of the leaflet windows 137.

In accordance with an embodiment, the valve 100 can be configured to prevent interference with a heart conduction system by not covering a bundle branch in the left ventricle when implanted, such as might be encountered with an aortic valve replacement procedure. For example, the valve 100 can comprise a length of less than about 25 mm or less than about 18 mm. The valve 100 can also comprise an aspect ratio of less than one, wherein the ratio describes the relationship between the length of the valve 100 to the expanded, functional diameter. However, the valve 100 can be constructed at any length and, more generally, any desirable dimension.

In a transcatheter embodiment, in a collapsed state, the valve 100 can have a collapsed profile that is less than about 35% of the expanded profile. For example, the valve 100 comprising a 26 mm expanded diameter can have a collapsed diameter of less than about 8 mm, or less than about 6 mm. The percent difference in diameter is dependent on dimensions and materials of the valve 100 and its various applications, and therefore, the actual percent difference is not limited by this disclosure.

The valve 100 can further comprise a bio-active agent. Bio-active agents can be coated onto a portion or the entirety of the film 160 for controlled release of the agents once the valve 100 is implanted. The bio-active agents can include, but are not limited to, vasodilator, anti-coagulants, anti-platelet, anti-thrombogenic agents such as, but not limited to, heparin. Other bio-active agents can also include, but are not limited to agents such as, for example, anti-proliferative/antimitotic agents including natural products such as vinca alkaloids (i.e. vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (i.e. etoposide, teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes (L-asparaginase which systemically metabolizes L-asparagine and deprives cells which do not have the capacity to synthesize their own asparagine); antiplatelet agents such as G(GP) IIb/IIIa inhibitors and vitronectin receptor antagonists; anti-proliferative/antimitotic alkylating agents such as nitrogen mustards (mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nitrosoureas (carmustine (BCNU) and analogs, streptozocin), trazenes-dacarbazinine (DTIC); anti-proliferative/antimitotic antimetabolites such as folic acid analogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide; hormones (i.e. estrogen); anti-coagulants (heparin, synthetic heparin salts and other inhibitors of thrombin); fibrinolytic agents (such as tissue plasminogen activator, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory; antisecretory (breveldin); anti-inflammatory: such as adrenocortical steroids (cortisol, cortisone, fludrocortisone, prednisone, prednisolone, 6α-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (salicylic acid derivatives i.e. aspirin; para-aminophenol derivatives i.e. acetominophen; indole and indene acetic acids (indomethacin, sulindac, and etodalac), heteroaryl acetic acids (tolmetin, diclofenac, and ketorolac), arylpropionic acids (ibuprofen and derivatives), anthranilic acids (mefenamic acid, and meclofenamic acid), enolic acids (piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds (auranofin, aurothioglucose, gold sodium thiomalate); immunosuppressives: (cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenic agents: vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; anti-sense oligionucleotides and combinations thereof; cell cycle inhibitors, mTOR inhibitors, and growth factor receptor signal transduction kinase inhibitors; retenoids; cyclin/CDK inhibitors; HMG co-enzyme reductase inhibitors (statins); and protease inhibitors.

Transcatheter Delivery System

In an embodiment, with reference to FIG. 4A, a valve delivery system 500 comprises a valve 100 having a collapsed configuration and an expanded configuration as previously described and an elongated flexible catheter 480, such as a balloon catheter, configured to deploy the valve 100 via endovascular access. The catheter 480 can comprise a balloon to expand the valve 100 and/or if required, to touch up the valve 100 to ensure proper seating. The valve 100 can be mounted to the distal section of the catheter 480 for delivery through the vasculature. In order to hold the valve in a collapsed configuration on the catheter 480, the valve delivery system may further comprise a removable sheath (not shown) to closely fit over the transcatheter valve 100.

A method of delivery can comprise the steps of radially compressing a valve into its collapsed configuration onto the distal end of an elongate flexible catheter having proximal and distal ends; delivering the valve to a tissue orifice, such as a native aortic valve orifice, via a transfemoral or transapical route, and expanding the valve into the tissue orifice. The valve can be expanded by inflating a balloon.

A method of delivery can comprise the steps of radially compressing a valve into its collapsed configuration, onto the distal section of an elongated flexible catheter having proximal and distal ends. A restraint, which can be connected to a tether that passes through the orifice of valve and the lumen of the catheter, is fitted around the posts of the valve. The valve is then delivered to a native valve orifice, such as a native aortic valve orifice, via a route of delivery and expanded into the native orifice. The route of delivery can comprise a transfemoral or transapical route. The valve can be expanded by inflating a balloon.

Surgical Embodiments

It is appreciated that the embodiments of the valve 100 may be surgically implanted rather than using transcatheter techniques. Embodiments of a surgically implanted valve 100 may be substantially the same as those described above, with the addition of a sewing cuff 171 adjacent to the outer frame outer surface 126a, shown in FIG. 4B, in accordance with an embodiment. The sewing cuff 171, which is well known in the art, is operable to provide structure that receives suture for coupling the valve 100 to an implant site, such as the tissue orifice. The sewing cuff 171 may comprise any suitable material, such as, but not limited to, double velour polyester. The sewing cuff 171 may be located circumferentially around the outer frame 120 or perivalvular depending from the outer frame 120.

Single Frame Valves

It is appreciated that embodiments of prosthetic valves are anticipated comprising the leaflet frame 130 and the film 160, without the outer frame 120. Referring to FIGS. 8D-8F, 11A-11B, embodiments of prosthetic valves comprising the leaflet frames 130f-130h are anticipated. The constructs of a single frame prosthetic valve in accordance with embodiments herein are provided suitable for a particular purpose. In accordance with embodiments of a surgically implanted valve having only the leaflet frame and film, may be substantially the same as those described above but without the outer frame, with the addition of a sewing cuff 171 shown in FIG. 4B, in accordance with an embodiment.

Method of Making

With reference to FIGS. 9A-9B, an embodiment of a method of making a valve 100 comprises the steps of wrapping a first layer of film 160, e.g., a composite as described herein, into a tubular form about the mandrel 710; placing the leaflet frame 130 and outer frame 120 over the first layer of film 160, as shown in FIG. 9A; forming a second layer of film 160 over the leaflet frame 130 and the outer frame 120; thermally setting the assembly; cutting the film 160 across the leaflet window top within the leaflet window 137, masking with release material 170 a portion of the film 160 in the leaflet window that defines the leaflet 140 to prevent further bonding of leaflet 140 during subsequent processing steps; wrapping a second layer of film 160 into a tubular form over the leaflet frame 130, the outer frame 120, and over the first layer of film 160; thermal setting the assembly; remove the assembly from the mandrel, telescopically insert the leaflet frame into the outer frame; placing the assembly back on the mandrel; thermal setting the assembly to couple the leaflet frame 130 to the outer frame 120 in nesting engagement.

Embodiments described herein also pertain to a method of making the valve 100 embodiments as described herein. In order to make the various embodiments, a cylindrical mandrel 710 can be used. With reference to FIG. 12, the mandrel 710 comprises a structural form operable to receive the leaflet frame 130 thereon. An embodiment of a method of making a valve 100 comprises the steps of wrapping a first layer of film 160, e.g., a composite as described herein, into a tubular form about the mandrel 710; placing the leaflet frame 130 over the first layer of film 160, as shown in FIG. 12; forming a second layer of film 160 over the leaflet frame 130; thermally setting the assembly; receiving the assembly over a cutting mandrel 712 as shown in FIGS. 13A and 13B; cutting the film 160 across the leaflet window top within the leaflet window 137, resulting in the valve 100 of FIG. 11B.

EXAMPLES
Example 1

A heart valve was produced having polymeric leaflets formed from a composite material having an expanded fluoropolymer membrane and an elastomeric material and joined between two collapsible metallic frames.

The leaflet frame and outer frame were laser machined from a length of SS316LVM tube hard tempered with an outside diameter of 23.0 mm and a wall thickness of 0.65 mm in the shape shown illustratively and generally indicated in FIG. 9A. The leaflet frame 130 and outer frame 120 were electro-polished resulting in 0.0127 mm material removal from each surface and leaving the edges rounded.

Fluorinated ethylene propylene (FEP) powder (Daikin America, Orangeburg N.Y.) was then applied to the leaflet frame 130 and outer frame 120. More specifically, the FEP powder was stirred to form an airborne “cloud” in an enclosed blending apparatus, such as a standard kitchen type blender, while the frames were suspended in the cloud. The frames were exposed to the FEP powder cloud until a uniform layer of powder was adhered to the entire surface of the frames. The frames were then subjected to a thermal treatment by placing it in a forced air oven set to 320° C. for approximately three minutes. This caused the powder to melt and adhere as a thin coating over the entire frame. The frames were removed from the oven and left to cool to room temperature.

Initial Assembly and Thermal Process Cycle

A 21 mm diameter vented metal cylindrical mandrel having a diameter corresponding to the inner diameter of the leaflet frame 130 and outer frame 120 was helically wrapped with sintered ePTFE fiber. A thin film of type 1 (ASTM D3368) FEP was constructed using melt extrusion and stretching. The type 1 (ASTM D3368) FEP film was about 40 μm thick and was about 7.7 cm wide. The mandrel was helically wrapped with one layer of this type 1 FEP film over the sintered ePTFE fiber only in the region of outer frame.

The mandrel was radially wrapped with five layers of an ePTFE membrane with an FEP coating towards the mandrel. The ePTFE membrane was manufactured according to the general teachings described in U.S. Pat. No. 7,306,729. The ePTFE membrane had a mass per area of 2.3 g/m², a bubble point of 101.5 MPa, a thickness of about 356 nm, a matrix tensile strength of 319 MPa in the longitudinal direction and 407 MPa in the transverse direction.

The mandrel was helically wrapped with one layer of type 1 FEP film.

The diameter of the leaflet frame and outer frame were expanded slightly and received on the wrapped mandrel with approximately a 10 mm space between them, rotational alignment was not necessary.

The leaflet frame, outer frame and the space therebetween were helically wrapped with 1 layer of type 1 FEP film.

The leaflet frame, outer frame and the space therebetween that will become the bridge portion 162, were circumferentially wrapped with 5 layers of the same ePTFE membrane with an FEP coating as described above with the coating toward the mandrel.

The wrapped leaflet frame, outer frame and the space therebetween were wrapped with several layers of an ePTFE membrane imbibed with a polyimide material referred to as a release liner.

A substantially nonporous ePTFE membrane was configured into a cylinder and placed over the assembly, referred to as sacrificial tube. Sintered ePTFE fiber was used to seal both ends of the sacrificial tube against the mandrel.

The assembly, including the mandrel, was heated in an oven capable of applying pneumatic pressure external to the sacrificial tube described above and while maintaining a vacuum internal to the mandrel for 40 min such that the mandrel temperature reached approximately 360° C. The assembly was removed from the oven and allowed to cool to room temperature while still pressurized and under vacuum.

The sacrificial tube and release liner was removed. The sintered ePTFE fiber was removed to release the frame assembly from the mandrel.

The polymeric material was trimmed and removed from the leaflet windows of the leaflet frame. The ends of each frame were circumferentially trimmed by a scalpel.

Intermediate Assembly and Thermal Process Cycle

An unsintered 15 mm diameter ePTFE tube was disposed on a 21.5 mm vented metal mandrel. Two layers of a substantially nonporous ePTFE membrane with a FEP coating was circumferentially wrapped on the mandrel with the coating side towards the mandrel. The wrapped mandrel was placed in a convection oven set to 320° C. and heated for 20 min. The ePTFE and substantially nonporous ePTFE membrane combined to serve as a release liner and was perforated to communicate pressure between the vent holes in the mandrel.

The leaflet frame was disposed onto the vented metal mandrel and vent holes were made in the apertures of the leaflet frame over the mandrel vent holes.

A leaflet material was then prepared. A membrane of ePTFE was manufactured according to the general teachings described in U.S. Pat. No. 7,306,729. The ePTFE membrane had a mass per area of 0.452 g/m², a thickness of about 508 nm, a matrix tensile strength of 705 MPa in the longitudinal direction and 385 MPa in the transverse direction. This membrane was imbibed with a fluoroelastomer. The copolymer consists essentially of between about 65 and 70 weight percent perfluoromethyl vinyl ether and complementally about 35 and 30 weight percent tetrafluoroethylene.

The fluoroelastomer was dissolved in Novec HFE7500 (3M, St Paul, MN) in a 2.5% concentration. The solution was coated using a Mayer bar onto the ePTFE membrane (while being supported by a polypropylene release film) and dried in a convection oven set to 145° C. for 30 seconds. After 2 coating steps, the final ePTFE/fluoroelastomer or composite had a mass per area of 1.75 g/m², 29.3% fluoropolymer by weight, a dome burst strength of about 8.6 KPa, and thickness of 0.81 μm.

The following test methods were used to characterize the ePTFE layers and the multi-layered composite. The thickness was measured with a Mutitoyo Snap Gage Absolute, 12.7 mm (0.50″) diameter foot, Model ID-C112E, Serial #10299, made in Japan. The density was determined by a weight/volume calculation using an Analytical Balance Mettler PM400 New Jersey, USA. The force to break and tensile strengths were measured using an Instron Model #5500R Norwood, MA, load cell 50 kg, gage length=25.4 cm, crosshead speed=25 mm/minute (strain rate=100% per minute) with flat faced jaws. Unless otherwise noted, these test methods were used to generate the data in subsequent examples.

Ten layers of the composite leaflet material was wrapped around the leaflet frame with an elastomer rich side of the composite facing towards the mandrel. In exemplary embodiments, the composite material is oriented to have a predetermined matrix tensile strength along a direction generally perpendicular with the longitudinal axis of the combined tool assembly. More specifically, the predetermined matrix tensile strength is about 705 MPa.

The mandrel was radially wrapped with one layer of a substantially nonporous ePTFE membrane with an FEP coating towards the mandrel with a spacing 8 mm from the base of the leaflet frame. The ePTFE membrane was manufactured according to the general teachings described in U.S. Pat. No. 7,306,729. The ePTFE membrane had a mass per area of about 11 g/m², a thickness of about 5.5 μm, a matrix tensile strength of 310 MPa in the longitudinal direction and 103 MPa in the transverse direction.

A Kapton® (EI DuPont de Nemours, Inc., Wilmington, DE) polyimide film acting as a mask was wrapped over the substantially nonporous ePTFE membrane with an FEP coating layer.

The outer frame was placed on the mandrel with 10 mm spacing between the leaflet frame and the outer frame. The leaflet frame and the outer frame were aligned such that the longitudinal outer frame posts were collinear with the leaflet frame posts.

The leaflet frame and outer frame were wrapped with 24 layers of the composite leaflet material described earlier with an elastomer rich side of the composite facing towards the mandrel. In exemplary embodiments, the composite material is oriented to have a predetermined matrix tensile strength along a direction generally perpendicular with the longitudinal axis of the combined tool assembly. More specifically, the predetermined matrix tensile strength is about 705 MPa.

The final leaflet was comprised of 29.3% fluoropolymer by weight with a thickness of approximately 27 μm. Each leaflet had 34 layers of the composite and a ratio of thickness/number of layers of 0.8 μm.

The mandrel was again radially wrapped with one layer of a substantially nonporous ePTFE membrane with an FEP coating towards the mandrel with a spacing 8 mm from the base of the leaflet frame.

The assembly was wrapped with several layers of the sacrificial release liner. A sacrificial tube was placed over the assembly and sintered ePTFE fiber was used to seal both ends of the sacrificial tube against the mandrel.

The assembly was processed in an oven capable of applying pneumatic pressure external to the sacrificial material configured into a tube described above and while maintaining a vacuum internal to the tube for 25 min such that the mandrel temperature reached approximately 330° C. The assembly was removed from the oven and allowed to cool to room temperature while still pressurized and under vacuum.

The sacrificial tube and liner were removed from the frame assembly and the frame assembly was removed from the mandrel. The Kapton® mask was removed.

A scalpel was used to circumferentially trim the free edge of each leaflet and the distal end of leaflet frame.

Final Assembly and Thermal Process Cycle

The outer frame was radially expanded to a 24 mm diameter using a tapered mandrel.

A release liner as described above was placed on a 21.5 mm vented mandrel.

Three Kapton® masks were cut to the shape of leaflet window with a 30 mm tapered extension.

The frames with leaflet material were placed onto the mandrel and the tapered extensions of the Kapton® masks were inserted under the top ring of the leaflet frame from the trimmed end and were advanced axially until the masks aligned with the leaflet window.

The leaflet frame was wrapped with 2 layers of the type 1 FEP film.

A hot iron was used to remove the FEP film from the leaflet window region by melting it away from the perimeter and to tack the FEP film in all regions of leaflet frame outside the masks.

Vent holes were made within all the frame apertures and in the polymer tube region connecting the inner and outer frame.

While holding the leaflet frame in place, the outer frame was coaxially disposed over the leaflet frame by telescopically inverting the bridge portion of the contiguous tube.

The entire frame assembly was circumferentially wrapped with one substantially nonporous ePTFE membrane with an FEP coating towards the mandrel.

The frame assembly was removed from the mandrel.

A scalpel was used to circumferentially trim each end of leaflet frame.

The Kapton was rotationally peeled away from inside the outer frame and away from leaflets.

Using scissors, both ends of the leaflet frame were trimmed to follow frame contour.

The resulting valve 100 includes leaflets 140 formed from a composite material with more than one fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores of the more than one fluoropolymer layer. Each leaflet 140 is movable between a closed position, shown in FIG. 3B, in which blood is substantially prevented from flowing through the valve assembly, and an open position, shown in FIG. 3A, in which blood is allowed to flow through the valve assembly. Thus, the leaflets 140 of the valve 100 cycle between the closed and open positions generally to regulate blood flow direction in a human patient.

The performance of the valve leaflets was characterized on a real-time pulse duplicator that measured typical anatomical pressures and flows across the valve. The flow performance was characterized by the following process:

The valve assembly was potted into a silicone annular ring (support structure) to allow the valve assembly to be subsequently evaluated in a real-time pulse duplicator. The potting process was performed according to the recommendations of the pulse duplicator manufacturer (ViVitro Laboratories Inc., Victoria BC, Canada)

The potted valve assembly was then placed into a real-time left heart flow pulse duplicator system. The flow pulse duplicator system included the following components supplied by VSI Vivitro Systems Inc., Victoria BC, Canada: a Super Pump, Servo Power Amplifier Part Number SPA 3891; a Super Pump Head, Part Number SPH 5891B, 38.320 cm²cylinder area; a valve station/fixture; a Wave Form Generator, TriPack Part Number TP 2001; a Sensor Interface, Part Number VB 2004; a Sensor Amplifier Component, Part Number AM 9991; and a Square Wave Electro Magnetic Flow Meter, Carolina Medical Electronics Inc., East Bend, NC, USA.

In general, the flow pulse duplicator system uses a fixed displacement, piston pump to produce a desired fluid flow through the valve under test.

The heart flow pulse duplicator system was adjusted to produce the desired flow (5 L/min), mean pressure (15 mmHg), and simulated pulse rate (70 bpm). The valve under test was then cycled for about 5 to 20 minutes.

Pressure and flow data were measured and collected during the test period, including right ventricular pressures, pulmonary pressures, flow rates, and pump piston position. Shown illustratively in Figure XX is a graph of typical data outputs from the heart flow pulse duplicator system.

Parameters used to characterize the valve are effective orifice area and regurgitant fraction. The effective orifice area (EOA), which can be calculated as follows: EOA(cm²)=Q_rms/(51.6*(ΔP)^1/2) where Q_rmsis the root mean square systolic/diastolic flow rate (cm³/s) and ΔP is the mean systolic/diastolic pressure drop (mmHg).

Another measure of the hydrodynamic performance of a valve is the regurgitant fraction, which is the amount of fluid or blood regurgitated through the valve divided by the stroke volume.

The hydrodynamic performance measured values were; EOA=2.06 cm², and regurgitant fraction=8.2%.

Example 2

Another valve was made as described in Example 1 with the following exceptions.

Initial Assembly and Thermal Process Cycle

The diameter of the leaflet frame and outer frame were expanded slightly and received on the wrapped mandrel with 16 mm space between them, rotational alignment if the leaflet frame and outer frame was made.

Final Assembly and Thermal Process Cycle

A scalpel was used to cut above the mechanical linking tab. The tab was deformed to link inner and outer frames.

The hydrodynamic performance was measured. The performance values were; EOA=2.3 cm²and regurgitant fraction=11.8%.

Numerous characteristics and advantages have been set forth in the preceding description, including various alternatives together with details of the structure and function of the devices and/or methods. The disclosure is intended as illustrative only and as such is not intended to be exhaustive. It will be evident to those skilled in the art that various modifications can be made, especially in matters of structure, materials, elements, components, shape, size and arrangement of parts including combinations within the principles of the disclosure, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. To the extent that these various modifications do not depart from the spirit and scope of the appended claims, they are intended to be encompassed therein.

Example 3 (Single Frame Valve)

In exemplary embodiments, a heart valve having polymeric leaflets formed from a composite material having an expanded fluoropolymer membrane and an elastomeric material and joined to a semi-rigid, non-collapsible metallic frame, and further a having strain relief was constructed according to the following process:

A leaflet frame was laser machined from a length of MP35N cobalt chromium tube hard tempered with an outside diameter of 26.0 mm and a wall thickness of 0.6 mm in the shape. The frame was electro-polished resulting in 0.0127 mm material removal from each surface and leaving the edges rounded. The frame was exposed to a surface roughening step to improve adherence of leaflets to the frame. The frame was cleaned by submersion in an ultrasonic bath of acetone for approximately five minutes. The entire metal frame surface was then subjected to a plasma treatment using equipment (e.g. PVA TePLa America, Inc Plasma Pen, Corona, CA) and methods commonly known to those having ordinary skill in the art. This treatment also served to improve the wetting of the fluorinated ethylene propylene (FEP) adhesive.

FEP powder (Daikin America, Orangeburg N.Y.) was then applied to the frame. More specifically, the FEP powder was stirred to form an airborne “cloud” in an enclosed blending apparatus, such as a standard kitchen type blender, while the frame is suspended in the cloud. The frame was exposed to the FEP powder cloud until a layer of powder was adhered to the entire surface of the frame. The frame was then subjected to a thermal treatment by placing it in a forced air oven set to 320° C. for approximately three minutes. This caused the powder to melt and adhere as a thin coating over the entire frame. The frame was removed from the oven and left to cool to approximately room temperature.

The strain relief was attached to the frame in the following manner. A thin (122 μm) walled sintered 15 mm diameter ePTFE tube was disposed on a 24.5 mm vented metal mandrel by stretching radially over a tapered mandrel. Two layers of a substantially nonporous ePTFE membrane with a continuous FEP coating was circumferentially wrapped on the mandrel with the FEP side towards the mandrel. The wrapped mandrel was placed in a convection oven set to 320° C. and heated for 20 min. The ePTFE and substantially nonporous ePTFE membrane combined to serve as an inner release liner and was perforated using a scalpel blade to communicate pressure between the vent holes in the mandrel. This entire release liner is removed in a later step.

A 5 cm length of the thick (990μ) walled partially sintered 22 mm inner diameter ePTFE tube (density=0.3 g/cm³) was disposed onto the 24.5 mm vented metal mandrel with release liner. The ePTFE tube inner diameter was enlarged by stretching it on a tapered mandrel to accommodate the larger mandrel diameter.

A thin (4 μm) film of type 1 FEP (ASTM D3368) was constructed using melt extrusion and stretching. One layer of the FEP was wrapped over the 5 cm length of the ePTFE tube.

The FEP powder coated frame was disposed onto the vented metal mandrel generally in the middle of the 5 cm span of ePTFE tube and FEP film.

One layer of the FEP was wrapped over the frame and 5 cm length of the ePTFE tube.

A second 5 cm length of the 990 μm thick/22 mm inner diameter ePTFE tube was disposed onto the assembly layered onto 24.5 mm vented metal mandrel by stretching its radius over a tapered mandrel to accommodate the larger construct diameter.

A substantially nonporous ePTFE membrane was configured into a cylinder at a diameter larger than the construct and placed over the assembly, referred to as sacrificial tube. Sintered ePTFE fiber (e.g. Gore Rastex® Sewing Thread, Part # S024T2, Newark Del.) was used to seal both ends of the sacrificial tube against the mandrel.

The assembly, including the mandrel, was heated in a convection oven (temperature set point of 390° C.) capable of applying pneumatic pressure of 100 psi external to the sacrificial tube described above while maintaining a vacuum internal to the mandrel. The assembly was cooked for 40 min such that the mandrel temperature reached approximately 360° C. (as measured by a thermocouple direct contact with the inner diameter of the mandrel). The assembly was removed from the oven and allowed to cool to approximately room temperature while still under 100 psi pressure and vacuum.

The sacrificial tube was then removed. Approximately 30 psi of pressure was applied to the internal diameter of the mandrel to assist in removal of the assembly. The inner release liner was peeled away from the internal diameter of the assembly by inverting the liner and axially pulling it apart.

The polymeric material was trimmed with a scalpel and removed from the leaflet windows and bottom of the frame leaving approximately 0.5 to 1.0 mm of material overhang.

The fluoroelastomer was dissolved in Novec HFE7500 (3M, St Paul, MN) in a 2.5% concentration. The solution was coated using a mayer bar onto the ePTFE membrane (while being supported by a polypropylene release film) and dried in a convection oven set to 145° C. for 30 seconds. After 2 coating steps, the final ePTFE/fluoroelastomer or composite had a mass per area of 1.75 g/m², 29.3% fluoropolymer by weight, a dome burst strength of about 8.6 KPa, and thickness of 0.81 μm.

The final leaflet was comprised of 28.22% fluoropolymer by weight with a thickness of 50.3 μm. Each leaflet had 26 layers of the composite and a ratio of thickness/number of layers of 1.93 μm.

The resulting valve assembly includes leaflets formed from a composite material with more than one fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores of the more than one fluoropolymer layer. Each leaflet is movable between a closed position, shown illustratively in FIG. 3B, in which blood is substantially prevented from flowing through the valve assembly, and an open position, shown illustratively in FIG. 3A, in which blood is allowed to flow through the valve assembly. Thus, the leaflets of the valve assembly cycle between the closed and open positions generally to regulate blood flow direction in a human patient.

The hydrodynamic performance was measured prior to accelerated wear testing. The performance values were; EOA=2.4 cm²and regurgitant fraction=11.94%.

It will be apparent to those skilled in the art that various modifications and variations can be made in the present embodiments without departing from the spirit or scope of the embodiments. Thus, it is intended that the present embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Claims

1. A prosthetic valve comprising: a support structure having a longitudinal axis and defining a leaflet attachment zone between a pair of adjacent commissure posts, the pair of adjacent commissure posts defining a chord length; anda leaflet coupled to and extending from the leaflet attachment zone, the leaflet having leaflet sides, a leaflet base, and a leaflet free edge opposite the leaflet base, the leaflet base and the leaflet sides being coupled to the support structure, the leaflet including a base segment defining a straight line that is shorter than the chord length and is adjacent to the leaflet base, the leaflet operable to bend about the base segment during opening-closing cycles associated with blood pressure differentials across the prosthetic valve, the prosthetic valve being operable to be reduced in diameter for transcatheter delivery and radially expanded for deployment.
2. The prosthetic valve of claim 1, wherein the leaflet is defined by a material coupled to an outer surface of the support structure.
3. The prosthetic valve of claim 1, wherein the leaflet is defined by a material coupled to an inner surface of the support structure.
4. The prosthetic valve of claim 1, wherein the leaflet is defined by a material coupled to an inner surface and an outer surface of the support structure.
5. The prosthetic valve of claim 1, wherein the leaflet includes a first film positioned inside the support structure and a second film positioned outside the support structure, the first film bonded to the second film.
6. The prosthetic valve of claim 1, wherein the leaflet is characterized by an absence of intersecting creases.
7. The prosthetic valve of claim 1, wherein the support structure comprises a plurality of frame elements spanning the leaflet attachment zone.
8. The prosthetic valve of claim 7, wherein the plurality of frame elements are associated with an outer frame positioned coaxially with the support structure.
9. The prosthetic valve of claim 1, wherein the leaflet is operable to bend along and about the base segment.
10. The prosthetic valve of claim 1, wherein the base segment is spaced from the leaflet attachment zone.
11. A prosthetic valve comprising: a support structure having a longitudinal axis and defining a leaflet attachment zone between a pair of adjacent commissure posts; anda leaflet coupled to and extending from the leaflet attachment zone, the leaflet having leaflet sides, a leaflet base, and a leaflet free edge opposite the leaflet base, the leaflet base and the leaflet sides being coupled to the support structure, the leaflet including a straight base segment adjacent to the leaflet base, the leaflet including a planar zone having a planar zone base coincident with the straight base segment, the leaflet operable to bend about the straight base segment during opening-closing cycles associated with blood pressure differentials across the prosthetic valve, the prosthetic valve being operable to be reduced in diameter for transcatheter delivery and radially expanded for deployment.
12. The prosthetic valve of claim 11, wherein the pair of adjacent commissure posts defining a chord length, and wherein the straight base segment is shorter than the chord length.
13. The prosthetic valve of claim 11, wherein the straight base segment defines a virtual leaflet base about which a portion of the leaflet is operable to bend during opening and closing of the leaflet.
14. The prosthetic valve of claim 11, wherein the leaflet is defined by a material coupled to an inner surface and an outer surface of the support structure.
15. The prosthetic valve of claim 11, wherein the leaflet includes a first film positioned inside the support structure and a second film positioned outside the support structure, the first film bonded to the second film.
16. A prosthetic valve comprising: a support structure having a longitudinal axis and defining a leaflet attachment zone between a pair of adjacent commissure posts; anda leaflet coupled to and extending from the leaflet attachment zone, the leaflet having leaflet sides, a leaflet base, and a leaflet free edge opposite the leaflet base, the leaflet base and the leaflet sides being coupled to the support structure, the leaflet including a flat portion defining a shelf portion, the leaflet operable to bend from the flat portion along a straight base segment towards the free edge during opening-closing cycles associated with blood pressure differentials across the prosthetic valve, the prosthetic valve being operable to be reduced in diameter for transcatheter delivery and radially expanded for deployment.
17. The prosthetic valve of claim 16, wherein the leaflet is defined by a material coupled to an inner surface of the support structure.
18. The prosthetic valve of claim 16, wherein the support structure comprises a plurality of frame elements spanning the leaflet attachment zone.
19. The prosthetic valve of claim 18, wherein the plurality of frame elements are associated with an outer frame positioned coaxially with the support structure.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No. 15/720,441, filed Sep. 29, 2017, which is a continuation of U.S. patent application Ser. No. 14/792,380, filed Jul. 6, 2015, now U.S. Pat. No. 9,827,089, issued Nov. 28, 2017, which is a divisional of U.S. patent application Ser. No. 13/869,878, filed Apr. 24, 2013, now U.S. Pat. No. 9,101,469, issued Aug. 11, 2015, which claims priority to Provisional Application 61/739,721, filed Dec. 19, 2012, all of which are incorporated herein by reference in their entireties for all purposes.

US Referenced Citations (556)

Number	Name	Date	Kind
654799	Levett	Jul 1900	A
3739402	Kahn et al.	Jun 1973	A
3938197	Milo	Feb 1976	A
3953566	Gore	Apr 1976	A
4053084	Anderson	Oct 1977	A
4178639	Bokros	Dec 1979	A
4187390	Gore	Feb 1980	A
4222126	Boretos et al.	Sep 1980	A
4265694	Boretos et al.	May 1981	A
4332035	Mano	Jun 1982	A
4340091	Skelton et al.	Jul 1982	A
4477930	Totten	Oct 1984	A
4556996	Wallace	Dec 1985	A
4626255	Reichart et al.	Dec 1986	A
4759759	Walker et al.	Jul 1988	A
4851000	Gupta	Jul 1989	A
4877661	House et al.	Oct 1989	A
4955899	Della et al.	Sep 1990	A
5026513	House et al.	Jun 1991	A
5064435	Porter	Nov 1991	A
5071609	Tu et al.	Dec 1991	A
5123918	Perrier et al.	Jun 1992	A
5163955	Love et al.	Nov 1992	A
5415667	Frater	May 1995	A
5469868	Reger	Nov 1995	A
5476589	Bacino	Dec 1995	A
5489297	Duran	Feb 1996	A
5534007	St et al.	Jul 1996	A
5549663	Cottone, Jr.	Aug 1996	A
5554183	Nazari	Sep 1996	A
5554185	Block et al.	Sep 1996	A
5562729	Purdy	Oct 1996	A
5628791	Bokros et al.	May 1997	A
5673102	Suzuki et al.	Sep 1997	A
5708044	Branca	Jan 1998	A
5718973	Lewis et al.	Feb 1998	A
5749852	Schwab et al.	May 1998	A
5752934	Campbell et al.	May 1998	A
5759192	Saunders	Jun 1998	A
5769884	Solovay	Jun 1998	A
5772884	Tanaka et al.	Jun 1998	A
5788626	Thompson	Aug 1998	A
5814405	Branca et al.	Sep 1998	A
5824043	Cottone, Jr.	Oct 1998	A
5843158	Lenker et al.	Dec 1998	A
5843161	Solovay	Dec 1998	A
5843171	Campbell et al.	Dec 1998	A
5853419	Imran	Dec 1998	A
5925061	Ogi et al.	Jul 1999	A
5928281	Huynh et al.	Jul 1999	A
5935162	Dang	Aug 1999	A
5935163	Gabbay	Aug 1999	A
5944654	Crawford	Aug 1999	A
5957974	Thompson et al.	Sep 1999	A
6010529	Hierweck et al.	Jan 2000	A
6013854	Moriuchi	Jan 2000	A
6019785	Strecker	Feb 2000	A
6035896	Liardet	Mar 2000	A
6042588	Munsinger et al.	Mar 2000	A
6042605	Martin et al.	Mar 2000	A
6042606	Frantzen	Mar 2000	A
6086612	Jansen	Jul 2000	A
6110198	Fogarty et al.	Aug 2000	A
6117169	Moe	Sep 2000	A
6129758	Love	Oct 2000	A
6161399	Jayaraman	Dec 2000	A
6165211	Thompson	Dec 2000	A
6171335	Wheatley et al.	Jan 2001	B1
6174329	Callol et al.	Jan 2001	B1
6174331	Moe et al.	Jan 2001	B1
6190406	Duerig et al.	Feb 2001	B1
6197143	Bodnar	Mar 2001	B1
6217609	Haverkost	Apr 2001	B1
6245012	Kleshinski	Jun 2001	B1
6261320	Tam et al.	Jul 2001	B1
6261620	Michael	Jul 2001	B1
6283994	Moe	Sep 2001	B1
6283995	Moe et al.	Sep 2001	B1
6287334	Moll et al.	Sep 2001	B1
6328763	Love et al.	Dec 2001	B1
6334873	Lane et al.	Jan 2002	B1
6336937	Vonesh et al.	Jan 2002	B1
6352552	Levinson et al.	Mar 2002	B1
6379382	Yang	Apr 2002	B1
6436132	Patel et al.	Aug 2002	B1
6454798	Moe	Sep 2002	B1
6454799	Schreck	Sep 2002	B1
6461382	Cao	Oct 2002	B1
6461665	Scholander	Oct 2002	B1
6482228	Norred	Nov 2002	B1
6488701	Nolting et al.	Dec 2002	B1
6541589	Baillie	Apr 2003	B1
6558418	Carpentier et al.	May 2003	B2
6562069	Cai et al.	May 2003	B2
6582464	Gabbay	Jun 2003	B2
6613086	Moe et al.	Sep 2003	B1
6620190	Colone	Sep 2003	B1
6626939	Burnside et al.	Sep 2003	B1
6645244	Shu et al.	Nov 2003	B2
6666885	Moe	Dec 2003	B2
6673102	Vonesh et al.	Jan 2004	B1
6673107	Brandt et al.	Jan 2004	B1
6726715	Sutherland	Apr 2004	B2
6730118	Spenser et al.	May 2004	B2
6730120	Berg et al.	May 2004	B2
6755856	Fierens et al.	Jun 2004	B2
6755857	Peterson et al.	Jun 2004	B2
6758858	McCrea et al.	Jul 2004	B2
6890350	Walak	May 2005	B1
6893460	Spenser et al.	May 2005	B2
6916338	Speziali	Jul 2005	B2
6936067	Buchanan	Aug 2005	B2
6953332	Kurk et al.	Oct 2005	B1
7022132	Kocur	Apr 2006	B2
7049380	Chang et al.	May 2006	B1
7083642	Sirhan et al.	Aug 2006	B2
7105018	Yip et al.	Sep 2006	B1
7137184	Schreck	Nov 2006	B2
7163556	Xie et al.	Jan 2007	B2
7238200	Lee et al.	Jul 2007	B2
7247167	Gabbay	Jul 2007	B2
7306729	Bacino et al.	Dec 2007	B2
7381218	Schreck	Jun 2008	B2
7419678	Falotico	Sep 2008	B2
7462675	Chang et al.	Dec 2008	B2
7510575	Spenser et al.	Mar 2009	B2
7513909	Lane et al.	Apr 2009	B2
7531611	Sabol et al.	May 2009	B2
7563277	Case et al.	Jul 2009	B2
7708775	Rowe et al.	May 2010	B2
7727274	Zilla et al.	Jun 2010	B2
7758640	Vesely	Jul 2010	B2
7780725	Haug et al.	Aug 2010	B2
7789908	Sowinski et al.	Sep 2010	B2
7803186	Li et al.	Sep 2010	B1
7811314	Fierens et al.	Oct 2010	B2
7815763	Fierens et al.	Oct 2010	B2
7879085	Sowinski et al.	Feb 2011	B2
7887562	Young et al.	Feb 2011	B2
7914569	Nguyen et al.	Mar 2011	B2
7927364	Fierens et al.	Apr 2011	B2
7927365	Fierens et al.	Apr 2011	B2
7935141	Randall et al.	May 2011	B2
7967829	Gunderson et al.	Jun 2011	B2
7967853	Eidenschink et al.	Jun 2011	B2
7993394	Hariton et al.	Aug 2011	B2
8048440	Chang et al.	Nov 2011	B2
8062359	Marquez et al.	Nov 2011	B2
8092523	Li et al.	Jan 2012	B2
8167935	McGuckin et al.	May 2012	B2
8226710	Nguyen et al.	Jul 2012	B2
8246678	Salahieh et al.	Aug 2012	B2
8252037	Styrc et al.	Aug 2012	B2
8303647	Case	Nov 2012	B2
8349000	Schreck	Jan 2013	B2
8409274	Li et al.	Apr 2013	B2
8475512	Hunt	Jul 2013	B2
8545525	Surti et al.	Oct 2013	B2
8568475	Nguyen et al.	Oct 2013	B2
8585753	Scanlon et al.	Nov 2013	B2
8585757	Agathos	Nov 2013	B2
8628566	Eberhardt et al.	Jan 2014	B2
8637144	Ford	Jan 2014	B2
8709077	Schreck	Apr 2014	B2
8722178	Ashmead et al.	May 2014	B2
8728103	Surti et al.	May 2014	B2
8728154	Alkhatib	May 2014	B2
8784481	Alkhatib et al.	Jul 2014	B2
8801774	Silverman	Aug 2014	B2
8808848	Bacino	Aug 2014	B2
8845709	Styrc et al.	Sep 2014	B2
8845721	Braido et al.	Sep 2014	B2
8852272	Gross et al.	Oct 2014	B2
8870948	Erzberger et al.	Oct 2014	B1
8936634	Irwin et al.	Jan 2015	B2
8945212	Bruchman et al.	Feb 2015	B2
8961599	Bruchman et al.	Feb 2015	B2
8992608	Haug et al.	Mar 2015	B2
9039757	McLean et al.	May 2015	B2
9101469	Bruchman et al.	Aug 2015	B2
9101696	Leontein et al.	Aug 2015	B2
9107771	Wubbeling et al.	Aug 2015	B2
9125740	Morriss et al.	Sep 2015	B2
9139669	Xu et al.	Sep 2015	B2
9144492	Bruchman et al.	Sep 2015	B2
9168131	Yohanan et al.	Oct 2015	B2
9198787	Kratzberg et al.	Dec 2015	B2
9241695	Peavey et al.	Jan 2016	B2
9259313	Wheatley	Feb 2016	B2
9283072	Bruchman et al.	Mar 2016	B2
9295552	McLean et al.	Mar 2016	B2
9314355	Styrc et al.	Apr 2016	B2
9345601	Jantzen et al.	May 2016	B2
9375308	Norris	Jun 2016	B2
9393110	Levi et al.	Jul 2016	B2
9398952	Bruchman et al.	Jul 2016	B2
9399085	Cleek et al.	Jul 2016	B2
9504565	Armstrong	Nov 2016	B2
9554786	Carley et al.	Jan 2017	B2
9554900	Bruchman et al.	Jan 2017	B2
9597181	Christianson et al.	Mar 2017	B2
9629718	Gloss et al.	Apr 2017	B2
9681948	Levi et al.	Jun 2017	B2
9737398	Bruchman et al.	Aug 2017	B2
9737422	Armstrong et al.	Aug 2017	B2
9743932	Amplatz et al.	Aug 2017	B2
9795496	Armstrong et al.	Oct 2017	B2
9801712	Bruchman et al.	Oct 2017	B2
9827089	Bruchman et al.	Nov 2017	B2
9827094	Bennett	Nov 2017	B2
9839540	Armstrong et al.	Dec 2017	B2
9855141	Dienno et al.	Jan 2018	B2
9931193	Cully et al.	Apr 2018	B2
9931204	Rothstein et al.	Apr 2018	B2
9937037	Dienno et al.	Apr 2018	B2
9968443	Bruchman et al.	May 2018	B2
10039638	Bruchman et al.	Aug 2018	B2
10166128	Armstrong et al.	Jan 2019	B2
10279084	Goepfrich et al.	May 2019	B2
10285808	Bruchman et al.	May 2019	B2
10314697	Gassler	Jun 2019	B2
10321986	Bruchman et al.	Jun 2019	B2
10335298	Armstrong et al.	Jul 2019	B2
10342659	Bennett	Jul 2019	B2
10368984	Armstrong	Aug 2019	B2
10376360	Bruchman et al.	Aug 2019	B2
10441416	Oba et al.	Oct 2019	B2
10463478	Bruchman et al.	Nov 2019	B2
10507124	Armstrong et al.	Dec 2019	B2
10639144	Bruchman et al.	May 2020	B2
10660745	Bruchman et al.	May 2020	B2
10881507	Bruchman et al.	Jan 2021	B2
10980633	Dienno et al.	Apr 2021	B2
11020221	Arcaro et al.	Jun 2021	B2
11039917	Bruchman et al.	Jun 2021	B2
D926322	Bennett et al.	Jul 2021	S
11065112	Gassler	Jul 2021	B2
11090153	Haarer et al.	Aug 2021	B2
11109963	Dienno et al.	Sep 2021	B2
11123183	Bennett et al.	Sep 2021	B2
11439502	Busalacchi et al.	Sep 2022	B2
11471276	Bennett	Oct 2022	B2
20010053929	Vonesh et al.	Dec 2001	A1
20020045936	Moe	Apr 2002	A1
20020055773	Campbell et al.	May 2002	A1
20020076542	Kramer et al.	Jun 2002	A1
20020082687	Moe	Jun 2002	A1
20020133226	Marquez et al.	Sep 2002	A1
20020151953	Chobotov et al.	Oct 2002	A1
20020183840	Lapeyre et al.	Dec 2002	A1
20020198588	Armstrong et al.	Dec 2002	A1
20020198594	Schreck	Dec 2002	A1
20030014105	Cao	Jan 2003	A1
20030027332	Lafrance et al.	Feb 2003	A1
20030055494	Bezuidenhout et al.	Mar 2003	A1
20030055496	Cai et al.	Mar 2003	A1
20030060871	Hill et al.	Mar 2003	A1
20030074052	Besselink et al.	Apr 2003	A1
20030097175	O'Connor et al.	May 2003	A1
20030114913	Spenser et al.	Jun 2003	A1
20030180488	Lim et al.	Sep 2003	A1
20030209835	Chun et al.	Nov 2003	A1
20030229394	Ogle et al.	Dec 2003	A1
20040024442	Sowinski et al.	Feb 2004	A1
20040024448	Chang et al.	Feb 2004	A1
20040024451	Johnson et al.	Feb 2004	A1
20040026245	Agarwal et al.	Feb 2004	A1
20040039436	Spenser et al.	Feb 2004	A1
20040044400	Cheng et al.	Mar 2004	A1
20040044401	Bales et al.	Mar 2004	A1
20040133266	Clerc et al.	Jul 2004	A1
20040170782	Wang et al.	Sep 2004	A1
20040176839	Huynh et al.	Sep 2004	A1
20040224442	Grigg	Nov 2004	A1
20040243222	Osborne et al.	Dec 2004	A1
20040260277	Maguire	Dec 2004	A1
20040260389	Case et al.	Dec 2004	A1
20040260393	Rahdert et al.	Dec 2004	A1
20050027348	Case et al.	Feb 2005	A1
20050080476	Gunderson et al.	Apr 2005	A1
20050119722	Styrc et al.	Jun 2005	A1
20050137680	Ortiz et al.	Jun 2005	A1
20050137682	Justino	Jun 2005	A1
20050203614	Forster et al.	Sep 2005	A1
20050261765	Liddicoat	Nov 2005	A1
20050283224	King	Dec 2005	A1
20060008497	Gabbay	Jan 2006	A1
20060009835	Osborne et al.	Jan 2006	A1
20060015171	Armstrong	Jan 2006	A1
20060036311	Nakayama et al.	Feb 2006	A1
20060041091	Chang et al.	Feb 2006	A1
20060106337	Blankenship	May 2006	A1
20060118236	House et al.	Jun 2006	A1
20060122693	Biadillah et al.	Jun 2006	A1
20060135985	Cox et al.	Jun 2006	A1
20060154365	Ratcliffe et al.	Jul 2006	A1
20060161241	Barbut et al.	Jul 2006	A1
20060190070	Dieck et al.	Aug 2006	A1
20060229718	Marquez	Oct 2006	A1
20060229719	Marquez et al.	Oct 2006	A1
20060259133	Sowinski et al.	Nov 2006	A1
20060259136	Nguyen et al.	Nov 2006	A1
20060265053	Hunt	Nov 2006	A1
20060271091	Campbell et al.	Nov 2006	A1
20060276813	Greenberg	Dec 2006	A1
20060276883	Greenberg et al.	Dec 2006	A1
20060276888	Lee et al.	Dec 2006	A1
20060282162	Nguyen et al.	Dec 2006	A1
20060287719	Rowe et al.	Dec 2006	A1
20060290027	O'Connor et al.	Dec 2006	A1
20070010876	Salahieh et al.	Jan 2007	A1
20070012624	Bacino et al.	Jan 2007	A1
20070021826	Case et al.	Jan 2007	A1
20070060999	Randall et al.	Mar 2007	A1
20070100435	Case et al.	May 2007	A1
20070118210	Pinchuk	May 2007	A1
20070129786	Beach et al.	Jun 2007	A1
20070207186	Scanlon et al.	Sep 2007	A1
20070207816	Spain, Jr.	Sep 2007	A1
20070208417	Agnew	Sep 2007	A1
20070208421	Quigley	Sep 2007	A1
20070213800	Fierens et al.	Sep 2007	A1
20070244552	Salahieh et al.	Oct 2007	A1
20070250146	Cully et al.	Oct 2007	A1
20070250153	Cully et al.	Oct 2007	A1
20070254012	Ludwig et al.	Nov 2007	A1
20080009940	Cribier	Jan 2008	A1
20080026190	King et al.	Jan 2008	A1
20080039934	Styrc	Feb 2008	A1
20080051876	Ta et al.	Feb 2008	A1
20080065198	Quintessenza	Mar 2008	A1
20080071369	Tuval et al.	Mar 2008	A1
20080082154	Tseng et al.	Apr 2008	A1
20080097301	Alpini et al.	Apr 2008	A1
20080097401	Trapp et al.	Apr 2008	A1
20080097579	Shanley et al.	Apr 2008	A1
20080097582	Shanley et al.	Apr 2008	A1
20080119943	Armstrong et al.	May 2008	A1
20080133004	White	Jun 2008	A1
20080140178	Rasmussen et al.	Jun 2008	A1
20080195199	Kheradvar et al.	Aug 2008	A1
20080208327	Rowe	Aug 2008	A1
20080220041	Brito et al.	Sep 2008	A1
20080228263	Ryan	Sep 2008	A1
20080300678	Eidenschink	Dec 2008	A1
20080319531	Doran et al.	Dec 2008	A1
20090005854	Juang et al.	Jan 2009	A1
20090030499	Bebb et al.	Jan 2009	A1
20090036976	Beach et al.	Feb 2009	A1
20090043373	Arnault et al.	Feb 2009	A1
20090104247	Pacetti	Apr 2009	A1
20090117334	Sogard et al.	May 2009	A1
20090138079	Tuval et al.	May 2009	A1
20090157175	Benichou	Jun 2009	A1
20090182413	Burkart et al.	Jul 2009	A1
20090240320	Tuval et al.	Sep 2009	A1
20090264997	Salahieh et al.	Oct 2009	A1
20090276039	Meretei	Nov 2009	A1
20090281609	Benichou et al.	Nov 2009	A1
20090287305	Amalaha	Nov 2009	A1
20090292350	Eberhardt et al.	Nov 2009	A1
20090306762	McCullagh et al.	Dec 2009	A1
20090306766	McDermott et al.	Dec 2009	A1
20100016940	Shokoohi et al.	Jan 2010	A1
20100023114	Chambers et al.	Jan 2010	A1
20100036021	Lee et al.	Feb 2010	A1
20100036484	Hariton et al.	Feb 2010	A1
20100049294	Zukowski et al.	Feb 2010	A1
20100082094	Quadri et al.	Apr 2010	A1
20100094394	Beach et al.	Apr 2010	A1
20100094405	Cottone	Apr 2010	A1
20100106240	Duggal et al.	Apr 2010	A1
20100114307	Agnew et al.	May 2010	A1
20100131056	Lapeyre	May 2010	A1
20100137998	Sobrino-Serrano et al.	Jun 2010	A1
20100145438	Barone	Jun 2010	A1
20100159171	Clough	Jun 2010	A1
20100168839	Braido et al.	Jul 2010	A1
20100185274	Moaddeb et al.	Jul 2010	A1
20100185277	Braido et al.	Jul 2010	A1
20100191320	Straubinger et al.	Jul 2010	A1
20100204781	Alkhatib	Aug 2010	A1
20100204785	Alkhatib	Aug 2010	A1
20100211165	Schreck	Aug 2010	A1
20100217382	Chau et al.	Aug 2010	A1
20100248324	Xu et al.	Sep 2010	A1
20100249923	Alkhatib et al.	Sep 2010	A1
20100256738	Berglund	Oct 2010	A1
20100262231	Tuval et al.	Oct 2010	A1
20100286760	Beach et al.	Nov 2010	A1
20100298931	Quadri et al.	Nov 2010	A1
20100305682	Furst	Dec 2010	A1
20110009953	Luk et al.	Jan 2011	A1
20110040366	Goetz et al.	Feb 2011	A1
20110054515	Bridgeman et al.	Mar 2011	A1
20110064781	Cleek et al.	Mar 2011	A1
20110087318	Daugherty et al.	Apr 2011	A1
20110160836	Behan	Jun 2011	A1
20110172784	Richter et al.	Jul 2011	A1
20110208283	Rust	Aug 2011	A1
20110218619	Benichou et al.	Sep 2011	A1
20110251678	Eidenschink et al.	Oct 2011	A1
20110257739	Corbett	Oct 2011	A1
20110282439	Thill et al.	Nov 2011	A1
20110295363	Girard et al.	Dec 2011	A1
20120035722	Tuval	Feb 2012	A1
20120078357	Conklin	Mar 2012	A1
20120083839	Letac et al.	Apr 2012	A1
20120089223	Nguyen et al.	Apr 2012	A1
20120101567	Jansen	Apr 2012	A1
20120101571	Thambar et al.	Apr 2012	A1
20120116496	Chuter et al.	May 2012	A1
20120116498	Chuter et al.	May 2012	A1
20120123529	Levi et al.	May 2012	A1
20120123530	Carpentier et al.	May 2012	A1
20120130468	Khosravi et al.	May 2012	A1
20120130471	Shoemaker et al.	May 2012	A1
20120185038	Fish et al.	Jul 2012	A1
20120215303	Quadri et al.	Aug 2012	A1
20120253453	Bruchman et al.	Oct 2012	A1
20120290082	Quint et al.	Nov 2012	A1
20120323211	Ogle et al.	Dec 2012	A1
20120323315	Bruchman et al.	Dec 2012	A1
20130018456	Li et al.	Jan 2013	A1
20130018458	Yohanan et al.	Jan 2013	A1
20130079700	Ballard et al.	Mar 2013	A1
20130110229	Bokeriya et al.	May 2013	A1
20130116655	Bacino et al.	May 2013	A1
20130131780	Armstrong et al.	May 2013	A1
20130150956	Yohanan et al.	Jun 2013	A1
20130158647	Norris et al.	Jun 2013	A1
20130166021	Bruchman et al.	Jun 2013	A1
20130183515	White	Jul 2013	A1
20130184807	Kovach et al.	Jul 2013	A1
20130197624	Armstrong et al.	Aug 2013	A1
20130204347	Armstrong et al.	Aug 2013	A1
20130204360	Gainor	Aug 2013	A1
20130253466	Campbell et al.	Sep 2013	A1
20130297003	Pinchuk	Nov 2013	A1
20130338755	Goetz et al.	Dec 2013	A1
20140005771	Braido et al.	Jan 2014	A1
20140005773	Wheatley	Jan 2014	A1
20140031924	Bruchman et al.	Jan 2014	A1
20140031927	Bruchman et al.	Jan 2014	A1
20140094898	Borck	Apr 2014	A1
20140106951	Brandon	Apr 2014	A1
20140135897	Cully et al.	May 2014	A1
20140163671	Bruchman et al.	Jun 2014	A1
20140163673	Bruchman et al.	Jun 2014	A1
20140172066	Goepfrich et al.	Jun 2014	A1
20140172069	Roeder et al.	Jun 2014	A1
20140172077	Bruchman et al.	Jun 2014	A1
20140172078	Bruchman et al.	Jun 2014	A1
20140172079	Bruchman et al.	Jun 2014	A1
20140172082	Bruchman et al.	Jun 2014	A1
20140172083	Bruchman et al.	Jun 2014	A1
20140180400	Bruchman et al.	Jun 2014	A1
20140180402	Bruchman et al.	Jun 2014	A1
20140194968	Zukowski	Jul 2014	A1
20140222140	Schreck	Aug 2014	A1
20140236289	Alkhatib	Aug 2014	A1
20140277413	Arnold et al.	Sep 2014	A1
20140277418	Miller	Sep 2014	A1
20140296969	Tegels et al.	Oct 2014	A1
20140324160	Benichou et al.	Oct 2014	A1
20140324164	Gross et al.	Oct 2014	A1
20140330368	Gloss et al.	Nov 2014	A1
20140343670	Bakis et al.	Nov 2014	A1
20150005870	Kovach et al.	Jan 2015	A1
20150018944	O'Connell et al.	Jan 2015	A1
20150088250	Zeng et al.	Mar 2015	A1
20150105856	Rowe et al.	Apr 2015	A1
20150142100	Morriss et al.	May 2015	A1
20150157456	Armstrong	Jun 2015	A1
20150157770	Cully et al.	Jun 2015	A1
20150224231	Bruchman et al.	Aug 2015	A1
20150245910	Righini et al.	Sep 2015	A1
20150313871	Li et al.	Nov 2015	A1
20150366663	Bruchman et al.	Dec 2015	A1
20150366664	Guttenberg et al.	Dec 2015	A1
20160001469	Bacchereti et al.	Jan 2016	A1
20160015422	De et al.	Jan 2016	A1
20160074161	Bennett	Mar 2016	A1
20160106537	Christianson et al.	Apr 2016	A1
20160113699	Sverdlik et al.	Apr 2016	A1
20160157998	Bruchman et al.	Jun 2016	A1
20160175095	Dienno et al.	Jun 2016	A1
20160175096	Dienno et al.	Jun 2016	A1
20160206424	Al-Jilaihawi et al.	Jul 2016	A1
20160213465	Girard et al.	Jul 2016	A1
20160235525	Rothstein et al.	Aug 2016	A1
20160310268	Oba et al.	Oct 2016	A1
20160317299	Alkhatib	Nov 2016	A1
20170027727	Wuebbeling et al.	Feb 2017	A1
20170042674	Armstrong	Feb 2017	A1
20170056169	Johnson et al.	Mar 2017	A1
20170065400	Armstrong et al.	Mar 2017	A1
20170095330	Malewicz et al.	Apr 2017	A1
20170095331	Spenser et al.	Apr 2017	A1
20170100236	Robertson et al.	Apr 2017	A1
20170105854	Treacy et al.	Apr 2017	A1
20170106176	Taft et al.	Apr 2017	A1
20170128199	Gurovich et al.	May 2017	A1
20170156859	Chang et al.	Jun 2017	A1
20170165066	Rothstein	Jun 2017	A1
20170165067	Barajas-Torres et al.	Jun 2017	A1
20170216062	Armstrong et al.	Aug 2017	A1
20170224481	Spenser et al.	Aug 2017	A1
20170252153	Chau et al.	Sep 2017	A1
20170348101	Vaughn et al.	Dec 2017	A1
20180021128	Bruchman et al.	Jan 2018	A1
20180021129	Peterson et al.	Jan 2018	A1
20180125646	Bruchman et al.	May 2018	A1
20180177583	Cully et al.	Jun 2018	A1
20180221144	Bruchman et al.	Aug 2018	A1
20180271651	Christianson et al.	Sep 2018	A1
20180271653	Vidlund et al.	Sep 2018	A1
20180318070	Bruchman et al.	Nov 2018	A1
20190076245	Arcaro et al.	Mar 2019	A1
20190091014	Arcaro et al.	Mar 2019	A1
20190091015	Dienno et al.	Mar 2019	A1
20190110893	Haarer et al.	Apr 2019	A1
20190125517	Cully et al.	May 2019	A1
20190125528	Busalacchi et al.	May 2019	A1
20190125530	Arcaro et al.	May 2019	A1
20190125531	Bennett et al.	May 2019	A1
20190125534	Arcaro et al.	May 2019	A1
20190209292	Bruchman et al.	Jul 2019	A1
20190209739	Goepfrich et al.	Jul 2019	A1
20190216592	Cully et al.	Jul 2019	A1
20190247185	Gassler	Aug 2019	A1
20190254815	Bruchman et al.	Aug 2019	A1
20190269505	Bruchman et al.	Sep 2019	A1
20190314154	Armstrong	Oct 2019	A1
20190328525	Noe et al.	Oct 2019	A1
20190374339	Bennett	Dec 2019	A1
20200000578	Bruchman et al.	Jan 2020	A1
20200022828	Armstrong et al.	Jan 2020	A1
20200179663	McDaniel et al.	Jun 2020	A1
20200237497	Silverman et al.	Jul 2020	A1
20200237505	Bruchman et al.	Jul 2020	A1
20200276014	Burkart et al.	Sep 2020	A1
20210121289	Bruchman et al.	Apr 2021	A1
20210177589	Arcaro et al.	Jun 2021	A1
20210205074	Bruchman et al.	Jul 2021	A1
20210307905	Arcaro et al.	Oct 2021	A1
20210338422	Dienno et al.	Nov 2021	A1
20210346156	Haarer et al.	Nov 2021	A1
20210361420	Bennett et al.	Nov 2021	A1
20210393399	Arcaro et al.	Dec 2021	A1
20220000611	Arcaro et al.	Jan 2022	A1
20220023032	Bruchman et al.	Jan 2022	A1
20220183831	Burkart et al.	Jun 2022	A1
20220257369	Burkart et al.	Aug 2022	A1
20220273426	Hagaman et al.	Sep 2022	A1
20220378575	Busalacchi et al.	Dec 2022	A1

Foreign Referenced Citations (214)

Number	Date	Country
2013363172	Jul 2015	AU
2017202405	Apr 2017	AU
2462509	Apr 2003	CA
2849030	Apr 2013	CA
2878691	Jan 2014	CA
2964546	Jan 2014	CA
2960034	Mar 2016	CA
101057796	Oct 2007	CN
101091675	Dec 2007	CN
101188985	May 2008	CN
101374477	Feb 2009	CN
101420913	Apr 2009	CN
101849863	Oct 2010	CN
101902989	Dec 2010	CN
101926699	Dec 2010	CN
201744060	Feb 2011	CN
102015009	Apr 2011	CN
102119013	Jul 2011	CN
102292053	Dec 2011	CN
102438546	May 2012	CN
102573703	Jul 2012	CN
102652694	Sep 2012	CN
102764169	Nov 2012	CN
102791223	Nov 2012	CN
102883684	Jan 2013	CN
103079498	May 2013	CN
103228232	Jul 2013	CN
103237524	Aug 2013	CN
103384505	Nov 2013	CN
103732183	Apr 2014	CN
103781439	May 2014	CN
103945796	Jul 2014	CN
104114127	Oct 2014	CN
104487023	Apr 2015	CN
104507417	Apr 2015	CN
104869948	Aug 2015	CN
105007955	Oct 2015	CN
105101911	Nov 2015	CN
105263445	Jan 2016	CN
105662651	Jun 2016	CN
105792780	Jul 2016	CN
106668949	May 2017	CN
106714733	May 2017	CN
106794065	May 2017	CN
107106294	Aug 2017	CN
107690323	Feb 2018	CN
108578016	Sep 2018	CN
212013000104	Nov 2014	DE
0293090	Nov 1988	EP
0313263	Apr 1989	EP
0582870	Feb 1994	EP
0775472	May 1997	EP
0815806	Jan 1998	EP
0893108	Jan 1999	EP
1318775	Jun 2003	EP
1666003	Jun 2006	EP
1395205	Jul 2008	EP
1235537	Dec 2008	EP
2193762	Jun 2010	EP
2255750	Dec 2010	EP
2400923	Jan 2012	EP
2359774	Jan 2013	EP
2591100	May 2013	EP
2109417	Nov 2013	EP
3142608	Mar 2017	EP
3797738	Mar 2021	EP
2591100	Jun 1987	FR
2312485	Oct 1997	GB
2513194	Oct 2014	GB
44-032400	Dec 1969	JP
1969-032400	Dec 1969	JP
02-000645	Jan 1990	JP
09-241412	Sep 1997	JP
10-507097	Jul 1998	JP
11-290448	Oct 1999	JP
11-512635	Nov 1999	JP
2000-511459	Sep 2000	JP
2000-513248	Oct 2000	JP
2001-508641	Jul 2001	JP
2001-508681	Jul 2001	JP
2001-509702	Jul 2001	JP
2001-511030	Aug 2001	JP
2002-525169	Aug 2002	JP
2002-541915	Dec 2002	JP
2004-510471	Apr 2004	JP
2005-500101	Jan 2005	JP
2005-512611	May 2005	JP
2007-525291	Sep 2007	JP
2007-526098	Sep 2007	JP
2007-536989	Dec 2007	JP
2008-506459	Mar 2008	JP
2008-535572	Sep 2008	JP
4335487	Sep 2009	JP
2010-500107	Jan 2010	JP
2010-504174	Feb 2010	JP
2010-517623	May 2010	JP
2010-528761	Aug 2010	JP
2010-188189	Sep 2010	JP
2010-535075	Nov 2010	JP
2010-536527	Dec 2010	JP
2012-504031	Feb 2012	JP
2012-152563	Aug 2012	JP
2013-543399	Dec 2013	JP
2014-513585	Jun 2014	JP
2014-517720	Jul 2014	JP
2016-501104	Jan 2016	JP
2016-518948	Jun 2016	JP
2017-527397	Sep 2017	JP
2018-079352	May 2018	JP
6392778	Sep 2018	JP
6802300	Dec 2020	JP
2124986	Jan 1999	RU
2434604	Nov 2011	RU
9413224	Jun 1994	WO
9416802	Aug 1994	WO
9505555	Feb 1995	WO
9509586	Apr 1995	WO
9602212	Feb 1996	WO
9607370	Mar 1996	WO
9640348	Dec 1996	WO
9710871	Mar 1997	WO
9926558	Jun 1999	WO
0018333	Apr 2000	WO
0041649	Jul 2000	WO
0047271	Aug 2000	WO
0062716	Oct 2000	WO
0128453	Apr 2001	WO
0141679	Jun 2001	WO
0164278	Sep 2001	WO
0174272	Oct 2001	WO
0207795	Jan 2002	WO
0224118	Mar 2002	WO
0224119	Mar 2002	WO
0245933	Jun 2002	WO
0247468	Jun 2002	WO
0260506	Aug 2002	WO
2002100301	Dec 2002	WO
0303946	Jan 2003	WO
0307795	Jan 2003	WO
0347468	Jun 2003	WO
0390834	Nov 2003	WO
2004000375	Dec 2003	WO
2005084595	Sep 2005	WO
2005112827	Dec 2005	WO
2006019626	Feb 2006	WO
2006058322	Jun 2006	WO
2006108090	Oct 2006	WO
2007016251	Feb 2007	WO
2008021002	Feb 2008	WO
2008028964	Mar 2008	WO
2008036870	Mar 2008	WO
2008049045	Apr 2008	WO
2008052421	May 2008	WO
2008091589	Jul 2008	WO
2008021006	Aug 2008	WO
2008097589	Aug 2008	WO
2008097592	Aug 2008	WO
2008150529	Dec 2008	WO
2009017827	Feb 2009	WO
2009029199	Mar 2009	WO
2009045332	Apr 2009	WO
2009100210	Aug 2009	WO
2009108355	Sep 2009	WO
2010006783	Jan 2010	WO
2010008570	Jan 2010	WO
2010030766	Mar 2010	WO
2010037141	Apr 2010	WO
2010057262	May 2010	WO
2010086460	Aug 2010	WO
2010132707	Nov 2010	WO
2010150208	Dec 2010	WO
2011098565	Aug 2011	WO
2011109450	Sep 2011	WO
2011109801	Sep 2011	WO
2011112706	Sep 2011	WO
2012004460	Jan 2012	WO
2012011261	Jan 2012	WO
2012040643	Mar 2012	WO
2012047644	Apr 2012	WO
2012065080	May 2012	WO
2012082952	Jun 2012	WO
2012099979	Jul 2012	WO
2012110767	Aug 2012	WO
2012116368	Aug 2012	WO
2012135603	Oct 2012	WO
2012158944	Nov 2012	WO
2012167131	Dec 2012	WO
2013074663	May 2013	WO
2013074990	May 2013	WO
2013096854	Jun 2013	WO
2013109337	Jul 2013	WO
2014018189	Jan 2014	WO
2014018432	Jan 2014	WO
2014099150	Jun 2014	WO
2014099163	Jun 2014	WO
2014099722	Jun 2014	WO
2014144937	Sep 2014	WO
2015045002	Apr 2015	WO
2015085138	Jun 2015	WO
2015171743	Nov 2015	WO
2015173794	Nov 2015	WO
2016028591	Feb 2016	WO
2016044223	Mar 2016	WO
2016100913	Jun 2016	WO
2016172349	Oct 2016	WO
2016186909	Nov 2016	WO
2017038145	Mar 2017	WO
2017096157	Jun 2017	WO
2019067219	Apr 2019	WO
2019067220	Apr 2019	WO
2019074607	Apr 2019	WO
2019074869	Apr 2019	WO
2019089138	May 2019	WO
2019246268	Dec 2019	WO

Non-Patent Literature Citations (17)

Entry
Norman E. Clough. Introducing a New Family of GORE (Trademark) ePTFE Fibers (2007).
Opposition from EP16196687.4, mailed on Dec. 12, 2019, 38 pages.
Opposition from EP17187595.8, filed Sep. 12, 2019, 50 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2018/050768, dated May 14, 2020, 8 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2018/050786, dated Apr. 23, 2020, 9 pages.
Cardiac Surgery in the Adult, Third Edition, Chapter 2 2008.
EPO Form 1002 for EP16196687.4 Filed Dec. 28, 2016.
Forward citations for E12 obtained from: https://scholar.google.com/scholar?cites=5981833429320176658&assdt=2005&sciodt=0,5&hl= en.
International Search Report and Written Opinion received for PCT Application No. PCT/US2020/020550, dated Jun. 9, 2020, 12 pages.
Google Image Search Results, “S-Shaped”, accessed Nov. 1, 2013.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US15/50113, dated Mar. 30, 2017, 9 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2020/027921, dated Oct. 21, 2021, 11 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2020/044603, dated Feb. 10, 2022, 9 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2020/044603, dated Oct. 20, 2020, 12 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2020/027921, dated Jul. 24, 2020, 16 pages.
Nakayama, Yasuhide. Microporous Stent Achieves Brain Aneurysm Occlusion Without Disturbing Branching Flow. NeuroNews Nov. 2012; 8:1-2.
Nishi S, Nakayama Y, Ishibashi-Ueda FI, Okamoto Y, Yoshida M. Development of microporous self-expanding stent grafts for treating cerebral aneurysms: designing micropores to control intimal hyperplasia. J Artif Organs 2011; 14:348-356.

Related Publications (1)

	Number	Date	Country
	20200246137 A1	Aug 2020	US

Provisional Applications (1)

	Number	Date	Country
	61739721	Dec 2012	US

Divisions (1)

	Number	Date	Country
Parent	13869878	Apr 2013	US
Child	14792380		US

Continuations (2)

	Number	Date	Country
Parent	15720441	Sep 2017	US
Child	16852825		US
Parent	14792380	Jul 2015	US
Child	15720441		US

Methods for improved prosthetic heart valve with leaflet shelving

Information

Patent Number

Date Filed

Date Issued

Inventors

Original Assignees

Examiners

Agents

CPC

Field of Search

US

International Classifications

Disclaimer

Term Extension

Abstract