Frame with integral sewing cuff for prosthetic valves

Information

  • Patent Grant
  • 11065112
  • Patent Number
    11,065,112
  • Date Filed
    Thursday, April 25, 2019
    6 years ago
  • Date Issued
    Tuesday, July 20, 2021
    4 years ago
Abstract
Described embodiments are related to a prosthetic valve for surgical placement with a sewing cuff durably attached to a frame. The durability of the attachment is accomplished by sandwiching a fabric between the frame and a composite material. The fabric extends beyond the frame base to form a sewing cuff that is integral to a frame assembly. The sewing cuff facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.
Description
FIELD

The present disclosure relates generally to prosthetic valves, and more specifically, a frame with integral sewing cuff-type prosthetic valve devices, systems, and methods.


BACKGROUND

Prosthetic heart valves have been developed that attempt to mimic the function and performance of a native valve. The prosthetic valve is typically attached to a human heart with sutures via a sewing cuff, or some other mechanical attachment means (e.g., staples).


Sewing cuffs generally comprise a toroidal member that is attached to the periphery of a prosthetic valve body to form a structure for anchoring sutures to the annulus of the heart during implantation of the prosthetic valve. Sewing cuffs commonly comprise a cloth material, such as polyester, and may also comprise a filler material such as Teflon felt or Dacron cloth. The sewing cuff may be coupled to a peripheral groove located on a lower end of the valve body by circumferential cinch-like sutures, or may be mechanically captured adjacent to a stiffening ring.


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 a frame assembly including an integral sewing cuff for use in a prosthetic valve.


In accordance with an embodiment, a prosthetic valve comprises a frame. The frame has a tubular shape with a frame inside surface and a frame outside surface opposite the frame inside surface. The prosthetic valve further comprises a fabric with fabric pores having a fabric frame portion and a sewing cuff opposite the fabric frame portion. The fabric frame portion has an elastomer present in the fabric pores. The fabric frame portion is coupled to the frame. The sewing cuff extends from the frame. A composite material is coupled to at least a portion of the fabric frame portion with the fabric frame portion disposed between the frame and the composite material. Leaflets are coupled to the frame.


In accordance with an embodiment, a prosthetic valve frame assembly comprises a frame. The frame has a tubular shape with a frame inside surface and a frame outside surface opposite the frame inside surface. The prosthetic valve further comprises a fabric with fabric pores having a fabric frame portion and a sewing cuff opposite the fabric frame portion. The fabric frame portion has an elastomer present in the fabric pores. The fabric frame portion is coupled to the frame. The sewing cuff extends from the frame. A composite material is coupled to at least a portion of the fabric frame portion with the fabric frame portion disposed between the frame and the composite material.


In accordance with an embodiment of method of making a frame assembly for a prosthetic valve, a first layer of film is wrapped into a tubular form about a mandrel. A fabric having a tubular shape is provided. The fabric is partially placed over the first layer of film. A frame having a tubular shape is provided. The frame has a frame inside surface and a frame outside surface and defines a frame base and a plurality of leaflet windows. The frame is placed over the fabric that is over the first layer of film with the frame inside surface in contact with the fabric. The fabric is everted over the frame base and over the frame outside surface in contact with the frame outside surface defining a fold in the fabric with the fold extending from the frame base, the fold defining a sewing cuff. A second layer of film is wrapped over the fabric that is over the frame outside surface. The first layer of film and the second layer of film are coupled to each other, to the fabric, and to the frame.





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 prosthetic valve;



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



FIG. 1C is an axial cross-sectional view along line C-C of the embodiment of the prosthetic valve of FIG. 1A;



FIG. 2A is a representation of an embodiment of a frame unrolled to a flat orientation;



FIG. 2B is a representation of another embodiment of a frame unrolled to a flat orientation;



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



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



FIG. 4 is a side view of an embodiment of a prosthetic valve within the anatomy;



FIG. 5 is a perspective view of an embodiment of an assembly mandrel; and



FIG. 6A-F are side views of stages in an example process for making a frame assembly with an integral sewing cuff, in accordance with an embodiment.





DEFINITIONS

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 prosthetic valve. In a closed position, the leaflet blocks retrograde flow through the prosthetic 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 prosthetic valve rises above the pressure on the outflow side of the prosthetic valve, the leaflets open and blood flows therethrough. As blood flows through the prosthetic 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 prosthetic valve raises above the blood pressure on the inflow side of the prosthetic valve, the leaflet returns to the closed position preventing retrograde flow of blood through the prosthetic valve. Leaflets may be comprised of biological tissue, such as bovine pericardium, or synthetic, biocompatible materials sufficiently compliant and flexible, such as a biocompatible polymer.


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 present within a porous structure of the membrane, coated on one or both sides of the membrane, or a combination of coated on and imbibed.


The term imbibed as used herein refers to the presence of material in the pores of a film. The process of imbibing as used herein refers to the means for depositing a material into the pores of the film. Means for imbibing may include, but are not limited to, printing, soaking, or any other suitable means for delivering materials into the pores.


The term laminate as used herein refers to an article comprising multiple layers of membrane, composite material, or other materials, such as elastomer, and combinations thereof, that are coupled together.


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


The term pores generally refers to void space that may be found in a material. Pores that are found in a fabric is referred to as fabric pores. Pores that are found in fluoropolymer membrane are referred to as fluoropolymer membrane pores. Pores also refers to void spaces in which another material may be present.


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, and 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 prosthetic valve for a particular purpose, and therefore the scope of the embodiments provided herein is not limited to native valve replacement.


The term couple as used herein is used synonymously with join, connect, attach, adhere, affix, or bond, whether directly or indirectly, and whether permanently or temporarily.


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 prosthetic valve or mechanism of similar structure and/or function. Furthermore, embodiments within the scope of this disclosure can be applied in non-cardiac applications.


Embodiments herein include various apparatus, systems, and methods for a prosthetic valve suitable for surgical placement, such as, but not limited to, cardiac valve replacement. The prosthetic valve is operable as a one-way valve wherein the prosthetic 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 a prosthetic valve with an integral sewing cuff that is durably attached to a frame and suitable for surgical placement. The durability of the attachment of the sewing cuff is accomplished by sandwiching a fabric between a frame and a composite material, in accordance with an embodiment. The fabric extends beyond a frame base to form a sewing cuff that is integral to the frame assembly.


As will be described below, in accordance with an embodiment, the sewing cuff facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.


Prosthetic Valve



FIG. 1A is a side view of a prosthetic valve 100, in accordance with an embodiment. FIG. 1B is a perspective view of the prosthetic valve 100 of FIG. 1A, and FIG. 1C is an axial cross-sectional view of a portion of the prosthetic valve 100 of FIG. 1A along cut-line C-C. The prosthetic valve 100 comprises leaflets 122 and a frame assembly 120 with sewing cuff 116. The frame assembly 120 with sewing cuff 116 comprises a frame 110 with a frame inside surface 124 and a frame outside surface 126, a fabric 112 with fabric pores that is coupled to the frame 110 defining a fabric frame portion 114 that extends beyond the frame 110 to form a sewing cuff 116, a composite material 118 coupled to at least a portion of the fabric frame portion 114 such that the fabric 112 is between the composite material 118 and the frame 110.


As shown in FIG. 1C, the fabric 112 and composite material 118 are coupled to both the frame inside surface 124 and frame outside surface 126 of the frame 110 thereby defining an inner fabric frame portion 128, an inner composite material 130, an outer fabric frame portion 132, and an outer composite material 134. In another embodiment, the fabric 112 and composite material 118 are coupled to only the frame inside surface 124 of the frame 110, defining an inner fabric frame portion 128 and an inner composite material 130. In yet another embodiment, the fabric 112 and composite material 118 are coupled to only the frame outside surface 126 of the frame 110, defining an outer fabric frame portion 132 and an outer composite material 134.


As shown in FIGS. 1A-1C, the composite material 118 may be coupled to substantially all of the fabric frame portion 114, that is, coupled to the frame 110. The composite material 118 may further extend beyond the frame 110 into the leaflet windows 144 to form the leaflets 122. Alternatively, leaflets 122 may be sewn or otherwise coupled to the frame assembly 120.


Frame


Referring to FIGS. 1A-1C, the frame 110 is a tubular member defining a predetermined repeating pattern. The frame 110 comprises a frame first end 136 and a frame second end 138 opposite the frame first end 136. Positioned at the frame first end 136 is the frame base 140. A plurality of spaced apart frame strut elements 142 extend from the frame first end 136 to the frame second end 138 in a predetermined repeating pattern. The frame 110 further comprises a frame outside surface 126 and a frame inside surface 124 opposite the frame outside surface 126, as shown in FIG. 1C.


The frame base 140 and frame strut elements 142 define leaflet windows 144. Each leaflet window 144 includes two leaflet window sides 146 and a leaflet window base 148. As will be described in more detail below, a biocompatible material is disposed over each of the leaflet windows 144 to form a leaflet 122. The leaflet window 144 may define any shape suitable for a particular purpose of an embodiment of a prosthetic valve 100, including, but not limited to a parabolic shape, a trapezoidal shape, and a triangular shape.


The frame 110 may be referred to in a general sense as a stent or a frame. The frame 110 defines any number of features and geometric shapes that facilitate support to the leaflet 122 and provide dimensional stability when implanted.


The frame 110 may comprise a cut tube or wire form, or any other element suitable for the particular purpose. The frame 110 may be etched, cut, laser cut, or stamped from 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.


The frame 110 can comprise any metallic or polymeric biocompatible material. For example, the frame 110 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.



FIGS. 2A-2B are side views of alternative embodiments of the frame 110a-110b where the frame has been cut longitudinally and laid open to better illustrate the elements of the frame.



FIG. 2A is a representation of an embodiment of a prosthetic valve 100a comprising a frame 110a that has been unrolled to a flat orientation to better illustrate the elements. The frame 110a is formed from a wire 145. The wire 145 is formed into a cylindrical shape that defines a plurality of U-shaped or parabola shaped leaflet windows 144a with leaflet window sides 146a that extend to the frame second end 138 and a leaflet window base 148a that is adjacent to the frame first end 136. The wire 145 further defines the frame base 140b at the frame first end 136.



FIG. 2B is a representation of an embodiment of a prosthetic valve 100b comprising a frame 110b that has been unrolled to a flat orientation to better illustrate the elements. The frame 110b comprises a plurality of spaced apart frame strut elements 142b defining substantially an isosceles triangle interconnected by another frame strut element 142b that defines the frame base 140b and defining leaflet windows 144b. Each leaflet window side 146b is defined by a side of one triangle and a side of an adjacent triangle, and wherein each leaflet window base 148b is defined by a frame strut element 142b that defines a portion of the frame base 140b. The frame second end 138 further comprises posts 152 extending from an apex of the frame strut elements 142b that define each of the isosceles triangles.


It is understood that the frame 110 may comprise any number of leaflet windows 144, and thus leaflets 122, suitable for a particular purpose, in accordance with embodiments. Frames comprising one, two, three or more leaflet windows and corresponding leaflets are anticipated.


Fabric and Sewing Cuff


In accordance with an embodiment of a prosthetic valve 100 suitable for surgical implantation, the prosthetic valve 100 further comprises a sewing cuff 116 about a frame outside surface 126 in accordance with an embodiment, as shown in FIGS. 1A-1C and FIG. 4. The sewing cuff 116 is operable to provide structure that receives suture for coupling the prosthetic valve 100 to the implant site, such as the tissue orifice. The sewing cuff 116 may be located circumferentially around the frame base 140 of the frame 110 or paravalvular, that is, extending axially from the frame base 140.


Referring again to the embodiment of FIG. 1C, a fabric 112 with fabric pores is coupled to the frame inside surface 124 and the frame outside surface 126. Portions of the fabric 112 that are coupled to the frame 110 define fabric frame portions 114. The sewing cuff 116 is formed from fabric 112 material that extends beyond the frame base 140. As shown in FIG. 1C, the fabric 112 defines a fabric first end 156, a fabric second end 158 opposite the fabric first end 156, and a fabric central portion 160 between the fabric first end 156 and the fabric second end 158. The fabric frame portion 114 comprises the fabric first end 156 which is coupled to the frame inside surface 124, and the fabric second end 158 which is coupled to the frame outside surface 126. The fabric central portion 160 comprises the sewing cuff 116, which is defined by a loop or fold of the fabric 112 extending beyond the frame base 140.


In an embodiment, the fabric 112 is coupled to substantially all of the frame inside surface 124 and substantially all of the frame outside surface 126, including the frame base 140 and the frame strut elements 142. In other embodiments the fabric 112 is coupled to a portion of the frame inside surface 124 and/or a portion of the frame outside surface 126. In other embodiments, the fabric 112 is coupled to the frame 110 at the frame base 140 on either the frame inside surface 124 and/or the frame outside surface 126. The fabric 112 may further extend, wholly or partially, into the leaflet windows 144. Extension of the fabric 112 at least partially into the leaflet window 144 may benefit the durability of the leaflet 144 as a reinforcement or a cushion layer between the frame 110 and the leaflet material that is coupled to the leaflet window 144.


In accordance with an embodiments, the fabric frame portion 114 has an elastomer present in the fabric pores of the fabric 112; in contrast, the sewing cuff 116 does not have an elastomer present in the fabric pores of fabric 112. This enables the sewing cuff 116 to be operable to facilitate tissue ingrowth into the fabric pores, but tissue ingrowth is discouraged elsewhere around the frame assembly 120. In another embodiment a predetermined portion of the sewing cuff 116 may have an elastomer present in the fabric pores of the fabric 112 so that tissue ingrowth is facilitated in specific regions of the sewing cuff 116 but not in others.


The sewing cuff 116 and fabric frame portion 114 may comprise any suitable fabric 112, such as, but not limited to, double velour polyester, PTFE, ePTFE, Dacron, or any other biocompatible fabric that does not deteriorate over time. The fabric 112 may be knit, woven, or non-woven. The sewing cuff 116 may further comprise a filler 162 between fabric layers. The filler 162 material may comprise the same material as the fabric 112 or may be any other suitable material, including silicone. The filler 162 may be a bead of material, a base tube rolled into an O-ring, one or more layers of a knit or woven material, wraps of a fiber, or any other suitable form. In some embodiments the filler 162 may be injected through a needle between the layers of the fabric 112 that form the sewing cuff 116 or inserted through a seam in the fabric 112 that is subsequently sewn together. The sewing cuff 116 may be located circumferentially around a perimeter of the frame 110.


In some embodiments the sewing cuff 116 and fabric frame portion 114 are comprised of a single piece of fabric. In other embodiments the sewing cuff 116 and fabric frame portion 114 are comprised of two or more fabric pieces which are coupled together by sewing, use of an adhesive, or any other suitable means.


Leaflet


Referring to FIGS. 1B and 2A-B, each leaflet window 144 is provided with a biocompatible material, such as a film or bovine pericardium, which is coupled to the leaflet window sides 146 and leaflet window base 148 with the biocompatible material defining a leaflet 122. The shape of the leaflets 122 are defined in part by the shape of the leaflet window 144 and the leaflet free edge 154.



FIGS. 3A and 3B are top axial views of a prosthetic valve 100 in an open and closed position, respectively. When the leaflets 122 are in a fully open position, the prosthetic valve 100 presents a valve orifice 102 that is substantially circular as shown in FIG. 3A. Fluid flow is permitted through the valve orifice 102 when the leaflets 122 are in an open position. When the leaflets 122 are in a closed position, the prosthetic valve 100 presents a substantially occluded orifice restricting fluid flow.


Film


A film 150 is any sheet-like material that is biologically compatible and configured to couple to the frame 110, 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.


In accordance with an embodiment, the biocompatible material is a film 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 comprises a biocompatible polymer that is combined with an elastomer, referred to as a composite material.


In an embodiment, the film 150 may be formed from a tubular shape to at least partially cover the frame 110. The film 150 can comprise one or more of a membrane, composite material, or laminate. Details of various types of film 150 are discussed below.


The biocompatible material that makes up the film can comprise any biological tissue or synthetic, biocompatible materials sufficiently compliant and flexible, such as a biocompatible polymer. In an embodiment, the film comprises a biocompatible polymer that is combined with an elastomer, referred to as a composite material. A material according to one embodiment includes a composite material comprising an expanded fluoropolymer membrane, which comprises a plurality of void 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 defining fluoropolymer membrane pores. 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, defining fluoropolymer membrane pores. 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 1.5×105 MPa2, 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 122 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 fluoropolymer membrane 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 the fluoropolymer membrane pores of the at least one fluoropolymer layer. Having elastomer filling the pore volume or present in the fluoropolymer membrane 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. In another embodiment, the elastomer is Silicone MED-4720, NuSil, Carpinteria, Calif., USA.


As discussed above, the elastomer is combined with the expanded fluoropolymer membrane such that the elastomer occupies the void space or fluoropolymer membrane pores within the expanded fluoropolymer membrane to form a composite material. This filling of the fluoropolymer membrane pores of the expanded fluoropolymer membrane with elastomer can be performed by a variety of methods. In one embodiment, a method of filling the fluoropolymer membrane 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 fluoropolymer membrane 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 fluoropolymer membrane pores of the expanded fluoropolymer membrane includes the steps of delivering the filler via a dispersion to partially or fully fill the fluoropolymer membrane pores of the expanded fluoropolymer membrane.


In another embodiment, a method of filling the fluoropolymer membrane 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 fluoropolymer membrane pores of the expanded fluoropolymer membrane.


In another embodiment, a method of filling the fluoropolymer membrane pores of the expanded fluoropolymer membrane includes the steps of polymerizing the elastomer within the fluoropolymer membrane pores of the expanded fluoropolymer membrane by first filling the fluoropolymer membrane 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 as a leaflet 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.


Other Considerations


The prosthetic valve 100 can further comprise a bio-active agent. Bio-active agents can be coated onto a portion or the entirety of the film 150 for controlled release of the agents once the prosthetic 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.


Method of Making


Embodiments described herein also pertain to a method of making the embodiments of a prosthetic valve as described herein. In order to make the various embodiments, a cylindrical assembly mandrel 168 can be used. With reference to FIGS. 5, 6A-6C, the assembly mandrel 168 comprises a structural form operable to receive the frame 110 thereon. An embodiment of a method of making a prosthetic valve 100 comprises the steps of coupling the fabric 112 to the frame 110 with a fabric central portion 160 of the fabric 112 extending beyond the frame base 140 that will be used to form the sewing cuff 116 of FIG. 1A; imbibing the fabric frame portion 114 with an elastomer so that the elastomer is present in the fabric pores of the fabric 112 while keeping the fabric central portion 160 of the fabric 112 that will be made into the sewing cuff 116 free of elastomer in the fabric pores of the fabric 112; thermally setting the assembly; coupling a composite material 118 to the fabric frame portion 114 such that the fabric frame portion 114 is between the frame 110 and the composite material 118.


EXAMPLE

A frame assembly 120 with sewing cuff 116 that is integral to the frame assembly 120 was made in the following manner. The following knit fabric was obtained. A 32 TPI, 32ga 2-bar in-lay warp knit was created using 100 denier, round ePTFE fiber (W.L. Gore and Associates, Elkton, Md.). Parallel cuts were made in the knit at 45 degrees relative to the warp direction and hand sewn into a 25 mm diameter tube using CV-4 GORE-TEX Suture (W.L. Gore and Associates, Flagstaff, Ariz.).


An assembly mandrel 168 was machined from aluminum in a cylindrical shape shown in perspective view in FIG. 5. The assembly mandrel 168 has a first end 170 and an opposing second end 172. Two rows of six 0.5 mm diameter vent holes 174 were drilled into the assembly mandrel 168 as shown in FIG. 5. The vent holes 174 communicate with a vent port 180.


Two layers of a sacrificial composite material comprising polyimide imbibed ePTFE film with a thickness of approximately 0.004 mm were wrapped around assembly mandrel 168. The sacrificial composite material was punctured above the vent holes 174.


Referring to FIG. 6A, the fabric 112 was an ePTFE knit tube 176. The ePTFE knit tube 176 was slid over the sacrificial material. Next, a 0.164 mm thick fluoroelastomer film was obtained. The fluoroelastomer was formulated according to the general teachings described in U.S. Pat. No. 7,462,675. A 40 mm wide strip of the fluoroelastomer film 178 was wrapped on top of the knit tube 176, for a total of 1 layer, positioned relative to vent holes 174 as shown in FIG. 6A.


A frame 110 was constructed as follows. The frame 110 was laser machined from a length of seamless MP35N tubing with a wall thickness of 0.60 mm.


Frame 110 was slid over the fluoroelastomer film 178 and positioned so that the frame base 140 was approximately 1 mm from the edge of fluoroelastomer film 178 as shown in FIG. 6B.


A 40 mm wide strip of the fluoroelastomer film 178 previously described in this example was wrapped on top of the frame 110 and aligned directly above the previously applied fluoroelastomer film 178, for a total of 3 additional layers.


A length of 3.2 mm diameter Gore Joint Sealant (W.L. Gore and Associates, Elkton, Md.) was wrapped around the assembly mandrel, just below the frame base 140 of the frame 110. This material used as filler 162 will provide bulk to the sewing cuff 116 as shown in FIG. 6C.


The excess length of the ePTFE knit tube 176 that is extending beyond the length of the frame 110 was pulled over the filler 162 and the frame 110 so that it extended beyond the frame strut elements 142 of the frame 110.


An ePTFE CV-4 suture was tied around the assembly mandrel 168 and located between the frame base 140 and the filler 162. The suture held the knit in close contact with the frame base 140 and the filler 162.


A 40 mm wide strip of the fluoroelastomer film 178 previously described in this example was wrapped on top of the frame 110 and aligned directly above the previously applied fluoroelastomer film 178, for a total of 14 additional layers.


Two layers of the previously described sacrificial composite material were wrapped on top of the coverings on the frame 110. Adhesive-backed polyimide tape was used to attach the ePTFE/polyimide composite to the assembly mandrel at each end and to seal the longitudinal seam thereby creating a fabric-frame assembly.


The fabric-frame assembly was then placed inside a heated pressure chamber. A vent port 180 in the first end 170 of the assembly mandrel 168 was plumbed to a vacuum source. The fabric-frame assembly was then subjected to 414 KPa pressure for about 26 minutes as the temperature inside the assembly mandrel reached about 260° C.


The pressure vessel was allowed to cool to room temperature. The pressure was released and the assembly mandrel 168 was removed from the pressure vessel. The resulting bonded fabric-frame assembly was slid off of the assembly mandrel 168 and the sacrificial ePTFE/polyimide composite material was removed.


The ePTFE knit tube 176 (the fabric in this embodiment) and fluoroelastomer film 178 of the bonded fabric-frame assembly 1500 was trimmed to within 1 mm of the frame. The fluoroelastomer filled the fabric pores or void spaces within the ePTFE knit in proximity to frame 110, both on the inner fabric frame portion 128 and outer fabric frame portion 132, as shown in FIG. 1C. The fluoroelastomer did not fill the fabric pores within the ePTFE knit and the filler 162 in the fabric central portion 160 of the sewing cuff 116.


With nothing on the assembly mandrel 168, two layers of the aforementioned sacrificial composite material were wrapped around the assembly mandrel 168 as previously described. The sacrificial composite material was punctured above the vent holes 174. A sacrificial layer of stainless steel foil 192 was wrapped around the assembly mandrel 168, adjacent to and extending away from the row of vent holes 174, as shown in FIG. 6D.


A composite material was then prepared as follows. A membrane layer of ePTFE was manufactured according to the general teachings described in U.S. Pat. No. 7,306,729. The ePTFE membrane was tested in accordance with the methods described herein. The ePTFE membrane had a mass per area of about 1.12 g/m2, a porosity of about 52%, a thickness of about 1.0 μm, a bubble point of about 458 KPa, a matrix tensile strength of about 481 MPa in the longitudinal direction and about 307 MPa in the transverse direction. This membrane was imbibed with the same fluoroelastomer as described previously in this example. The fluoroelastomer was dissolved in Fluorinert Electronic Liquid FC-72, 3M, St. Paul, Minn., USA in an about 3.0% concentration. The solution was coated using a die coater onto the ePTFE membrane (while being supported by a polyethylene release film) and dried in a convection oven set to about 110° C. for about 3 minutes. The resulting composite material of ePTFE/fluoroelastomer had a mass per area of about 3.6 g/m2.


The ePTFE/fluoroelastomer composite material 118 was wrapped around the assembly mandrel 168 and previously applied components for a total of 5 layers. The composite material 118 was trimmed with a razor blade against the sacrificial stainless steel foil, approximately 1 mm from the edge of the foil. The foil and trimmed composite was removed from the assembly mandrel 168.


The fabric-frame assembly 190 was slid onto the assembly mandrel 168 and positioned on top of the ePTFE/fluoroelastomer composite material so that the frame base 140 aligned with the edge of the composite material 118 as shown in FIG. 6E.


Two layers of the aforementioned sacrificial composite material were wrapped around the fabric-frame assembly so that the edge of the sacrificial composite aligned with the frame base 140 and covered the sewing cuff 116, as shown in FIG. 6F.


Twenty-seven (27) additional layers of the ePTFE/fluoroelastomer composite material 193 were wrapped around the assembly mandrel 168, completely covering all the previously applied components as shown in FIG. 6F.


Two layers of the aforementioned sacrificial composite material were wrapped around the assembly mandrel 168 and previously applied components. Adhesive-backed polyimide tape was used to attach the ePTFE/polyimide composite to the assembly mandrel 168 at each end and to seal the longitudinal seam.


The assembly mandrel 168 with previously applied components was then placed in a pressure vessel and pressurized as described above with the exceptions that the time and temperature were about 24 minutes and 262° C., respectively. This resulting frame assembly 120 with the sewing cuff 116 that is now integral to the frame assembly 120 was allowed to cool to room temperature, removed from the pressure vessel and slid off of the assembly mandrel 168, as shown in FIG. 6F.


The ePTFE/fluoroelastomer composite material was trimmed at the base of the valve frame, revealing the sewing cuff 116 that is still un-imbibed with elastomer.


In subsequent steps, leaflets were attached to the leaflet windows.


Testing Methods


It should be understood that although certain methods and equipment are described below, any method or equipment determined suitable by one of ordinary skill in the art may be alternatively utilized.


Mass, Thickness, and Density of ePTFE Membranes


Membrane samples were die cut to form rectangular sections about 2.54 cm by about 15.24 cm to measure the weight (using a Mettler-Toledo analytical balance model AG204) and thickness (using a Käfer Fz1000/30 snap gauge). Using these data, density was calculated with the following formula: ρ=m/(w*l*t), in which: ρ=density (g/cm3), m=mass (g), w=width (cm), l=length (cm), and t=thickness (cm). The average of three measurements was reported.


Matrix Tensile Strength (MTS) of ePTFE Membranes


Tensile break load was measured using an INSTRON 122 tensile test machine equipped with flat-faced grips and a 0.445 kN load cell. The gauge length was about 5.08 cm and the cross-head speed was about 50.8 cm/min. The sample dimensions were about 2.54 cm by about 15.24 cm. For highest strength measurements, the longer dimension of the sample was oriented in the highest strength direction. For the orthogonal MTS measurements, the larger dimension of the sample was oriented perpendicular to the highest strength direction. Each sample was weighed using a Mettler Toledo Scale Model AG204, then the thickness was measured using the Kafer FZ1000/30 snap gauge; alternatively, any suitable means for measuring thickness may be used. The samples were then tested individually on the tensile tester. Three different sections of each sample were measured. The average of the three maximum loads (i.e., peak force) measurements was reported. The longitudinal and transverse matrix tensile strengths (MTS) were calculated using the following equation: MTS=(maximum load/cross-section area)*(bulk density of PTFE)/(density of the porous membrane), where the bulk density of the PTFE was taken to be about 2.2 g/cm3. The porosity of the specimen is accounted for by multiplying the tensile strength by the ratio of density of the polymer to the density of the specimen.


Bubble Point and Mean Flow Pore Size


Bubble point and mean flow pore size were measured according to the general teachings of ASTM F31 6-03 using a capillary flow Porometer, Model CFP 1500AEXL from Porous Materials, Inc., Ithaca N.Y., USA. The sample membrane was placed into the sample chamber and wet with SilWick Silicone Fluid (available from Porous Materials Inc.) having a surface tension of about 20.1 dynes/cm. The bottom clamp of the sample chamber had an about 2.54 cm diameter hole. Using the Capwin software version 7.73.012 the following parameters were set as specified in the table below.
















Parameter
Set Point



















Maxflow (cm3/m)
200000



Bublflow (cm3/m)
100



F/PT (old bubltime)
50



Minbpress (PSI)
0



Zerotime (seconds)
1



V2incr (cts)
10



Preginc (cts)
1



Pulse delay (seconds)
2



Maxpre (PSI)
500



Pulse width (seconds)
0.2



Mineqtime (seconds)
30



Presslew (cts)
10



Flowslew (cts)
50



Eqiter
3



Aveiter
20



Maxpdif (PSI)
0.1



Maxfdif (PSI)
50



Sartp (PSI)
1



Sartf (cm3/m)
500










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 method of making a frame assembly for a prosthetic valve, comprising: coupling a frame defining a tubular shape to a fabric having fabric pores, the fabric defining a fabric frame portion and a sewing cuff portion opposite the fabric frame portion, wherein at least a portion of the fabric frame portion has an elastomer in the fabric pores and the sewing cuff portion of the fabric does not have an elastomer present in the fabric pores; andcoupling a composite material to at least a portion of the fabric frame portion with the fabric frame portion disposed between the frame and the composite material and such that the sewing cuff extends from the frame.
  • 2. The method of claim 1, further comprising: wrapping a first layer of film into a tubular form about a mandrel;placing the fabric partially over the first layer of film;placing the frame over the fabric that is over the first layer of film;everting the fabric over the frame to define a fold in the fabric with the fold, the fold defining the sewing cuff at a base of the frame;wrapping a second layer of film over the frame; andcoupling the first layer of film and the second layer of film to each other, to the fabric, and to the frame.
  • 3. The method of claim 2, further comprising providing filler material in the fold of the fabric, wherein after everting the fabric the filler material is contained within the fold.
  • 4. The method of claim 2, further comprising coupling one or more leaflets to the frame.
  • 5. The method of claim 2, the frame further comprising two or more frame strut elements extending from the base to define a plurality of leaflet windows.
  • 6. The method of claim 5, wherein one or more of the first layer of film and the second layer of film extends into each of the leaflet windows to define leaflets therein.
  • 7. The method of claim 2, wherein the frame has a frame inside surface and a frame outside surface opposite the frame inside surface, the fabric frame portion being coupled to the frame inside surface, the fabric frame portion disposed between the frame inside surface and the composite material.
  • 8. The method of claim 2, wherein the frame has a frame inside surface and a frame outside surface opposite the frame inside surface, the fabric frame portion being coupled to the frame inside surface and the frame outside surface, the fabric frame portion disposed between the frame inside surface and the composite material, and the fabric frame portion disposed between the frame outside surface and the composite material.
CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 15/502,871, filed Feb. 9, 2017, which is a national phase application of PCT Application No. PCT/US2015/045002, internationally filed Aug. 13, 2015, which claims the benefit of U.S. provisional Application No. 62/038,727, filed Aug. 18, 2014, all of which are herein incorporated by reference in their entireties.

US Referenced Citations (319)
Number Name Date Kind
654799 Levett Jul 1900 A
3953566 Gore Apr 1976 A
4178639 Bokros Dec 1979 A
4222126 Boretos et al. Sep 1980 A
4265694 Boretos et al. May 1981 A
4340091 Skelton et al. Jul 1982 A
4477930 Totten et al. 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
5123918 Perrier et al. Jun 1992 A
5163955 Love et al. Nov 1992 A
5415667 Frater May 1995 A
5469868 Reger Nov 1995 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
5708044 Branca Jan 1998 A
5928281 Van Le Huynh et al. Jul 1999 A
5935163 Gabbay Aug 1999 A
5944654 Crawford Aug 1999 A
6019785 Strecker Feb 2000 A
6086612 Jansen Jul 2000 A
6117169 Moe Sep 2000 A
6129758 Love Oct 2000 A
6171335 Wheatley et al. Jan 2001 B1
6174331 Moe et al. Jan 2001 B1
6197143 Bodnar Mar 2001 B1
6283994 Moe et al. 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
6454798 Moe Sep 2002 B1
6454799 Schreck Sep 2002 B1
6461382 Cao Oct 2002 B1
6482228 Norred Nov 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
6645244 Shu et al. Nov 2003 B2
6666885 Moe Dec 2003 B2
6726715 Sutherland Apr 2004 B2
6730118 Spenser et al. May 2004 B2
6755857 Peterson et al. Jun 2004 B2
6893460 Spenser et al. May 2005 B2
6916338 Speziali Jul 2005 B2
6936067 Buchanan Aug 2005 B2
6953332 Kurk et al. Oct 2005 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
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
7803186 Li et al. Sep 2010 B1
7879085 Sowinski et al. Feb 2011 B2
7914569 Nguyen et al. Mar 2011 B2
7967853 Eidenschink et al. Jun 2011 B2
7993394 Hariton et al. Aug 2011 B2
8062359 Marquez et al. Nov 2011 B2
8092523 Li et al. Jan 2012 B2
8167935 McGuckin, Jr. 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
8568475 Nguyen et al. Oct 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
8728154 Alkhatib May 2014 B2
8784481 Alkhatib et al. Jul 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
8945212 Bruchman et al. Feb 2015 B2
8961599 Bruchman et al. Feb 2015 B2
8992608 Haug et al. Mar 2015 B2
9101469 Bruchman 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
9283072 Bruchman et al. Mar 2016 B2
9314355 Styrc et al. Apr 2016 B2
9375308 Norris Jun 2016 B2
9393110 Levi et al. Jul 2016 B2
9398952 Bruchman et al. Jul 2016 B2
9504565 Armstrong Nov 2016 B2
9554900 Bruchman et al. Jan 2017 B2
9597181 Christianson et al. Mar 2017 B2
9629718 Gloss et al. Apr 2017 B2
9737398 Bruchman et al. Aug 2017 B2
9743932 Amplatz et al. Aug 2017 B2
9801712 Bruchman et al. Oct 2017 B2
9827089 Bruchman et al. Nov 2017 B2
9827094 Bennett Nov 2017 B2
9855141 Dienno et al. Jan 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
10285808 Bruchman et al. May 2019 B2
10314697 Gassler Jun 2019 B2
10321986 Bruchman et al. Jun 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
10639144 Bruchman et al. May 2020 B2
10660745 Bruchman et al. May 2020 B2
20020045936 Moe Apr 2002 A1
20020055773 Campbell et al. May 2002 A1
20020082687 Moe Jun 2002 A1
20020133226 Marquez et al. Sep 2002 A1
20020183840 Lapeyre et al. Dec 2002 A1
20020198594 Schreck Dec 2002 A1
20030027332 Lafrance et al. Feb 2003 A1
20030055496 Cai 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
20030229394 Ogle et al. Dec 2003 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
20040176839 Van Huynh et al. Sep 2004 A1
20040243222 Osborne et al. Dec 2004 A1
20040260393 Rahdert et al. Dec 2004 A1
20050027348 Case et al. Feb 2005 A1
20050119722 Styrc et al. Jun 2005 A1
20050137682 Justino Jun 2005 A1
20050261765 Liddicoat Nov 2005 A1
20060008497 Gabbay Jan 2006 A1
20060041091 Chang et al. Feb 2006 A1
20060122693 Biadillah et al. Jun 2006 A1
20060154365 Ratcliffe et al. Jul 2006 A1
20060229719 Marquez et al. Oct 2006 A1
20060265053 Hunt Nov 2006 A1
20060276813 Greenberg Dec 2006 A1
20060282162 Nguyen et al. Dec 2006 A1
20060290027 O'Connor et al. Dec 2006 A1
20070010876 Salahieh et al. Jan 2007 A1
20070021826 Case et al. Jan 2007 A1
20070118210 Pinchuk May 2007 A1
20070207186 Scanlon et al. Sep 2007 A1
20080009940 Cribier Jan 2008 A1
20080026190 King et al. Jan 2008 A1
20080039934 Styrc Feb 2008 A1
20080065198 Quintessenza Mar 2008 A1
20080071369 Tuval et al. Mar 2008 A1
20080082154 Tseng et al. Apr 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 et al. Dec 2008 A1
20090117334 Sogard et al. May 2009 A1
20090138079 Tuval et al. May 2009 A1
20090157175 Benichou Jun 2009 A1
20090240320 Tuval et al. Sep 2009 A1
20090264997 Salahieh et al. Oct 2009 A1
20090276039 Meretei Nov 2009 A1
20090287305 Amalaha Nov 2009 A1
20090292350 Eberhardt et al. Nov 2009 A1
20100023114 Chambers et al. Jan 2010 A1
20100036021 Lee et al. Feb 2010 A1
20100049294 Zukowski et al. Feb 2010 A1
20100082094 Quadri et al. Apr 2010 A1
20100131056 Lapeyre May 2010 A1
20100137998 Sobrino-Serrano et al. Jun 2010 A1
20100145438 Barone 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
20100262231 Tuval et al. Oct 2010 A1
20100298931 Quadri et al. Nov 2010 A1
20110040366 Goetz et al. Feb 2011 A1
20110054515 Bridgeman et al. Mar 2011 A1
20110064781 Cleek et al. Mar 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
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
20120253453 Bruchman et al. Oct 2012 A1
20120290082 Quint et al. Nov 2012 A1
20120323315 Bruchman et al. Dec 2012 A1
20130018456 Li 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
20130150956 Yohanan et al. Jun 2013 A1
20130158647 Norris et al. Jun 2013 A1
20130166021 Bruchman et al. Jun 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
20140163671 Bruchman et al. Jun 2014 A1
20140163673 Bruchman 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
20140194968 Zukowski Jul 2014 A1
20140236289 Alkhatib Aug 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
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
20150224231 Bruchman et al. Aug 2015 A1
20150245910 Righini et al. Sep 2015 A1
20150366663 Bruchman et al. Dec 2015 A1
20150366664 Guttenberg et al. Dec 2015 A1
20160001469 Bacchereti et al. Jan 2016 A1
20160074161 Bennett Mar 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
20160317299 Alkhatib Nov 2016 A1
20170027727 Wuebbeling et al. Feb 2017 A1
20170042674 Armstrong Feb 2017 A1
20170056169 Johnson et al. Mar 2017 A1
20170095330 Malewicz et al. Apr 2017 A1
20170128199 Gurovich et al. May 2017 A1
20170156859 Chang et al. Jun 2017 A1
20170165067 Barajas-Torres et al. Jun 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
20180125646 Bruchman et al. May 2018 A1
20180221144 Bruchman et al. Aug 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
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
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
20200237505 Bruchman et al. Jul 2020 A1
20200246137 Bruchman et al. Aug 2020 A1
20200276014 Burkart et al. Sep 2020 A1
Foreign Referenced Citations (99)
Number Date Country
2013363172 Jul 2015 AU
2878691 Jan 2014 CA
2964546 Jan 2014 CA
2960034 Mar 2016 CA
101057796 Oct 2007 CN
101091675 Dec 2007 CN
101374477 Feb 2009 CN
102119013 Jul 2011 CN
102438546 May 2012 CN
102573703 Jul 2012 CN
102652694 Sep 2012 CN
102764169 Nov 2012 CN
102791223 Nov 2012 CN
104487023 Apr 2015 CN
104507417 Apr 2015 CN
212013000104 Nov 2014 DE
1318775 Jun 2003 EP
1395205 Jul 2008 EP
2359774 Aug 2011 EP
2400923 Jan 2012 EP
2591100 May 2013 EP
3142608 Mar 2017 EP
2591100 Jun 1987 FR
2312485 Oct 1997 GB
2513194 Oct 2014 GB
44-032400 Dec 1969 JP
196932400 Dec 1969 JP
10-507097 Jul 1998 JP
2000511459 Sep 2000 JP
2000513248 Oct 2000 JP
2001-508681 Jul 2001 JP
2001-511030 Aug 2001 JP
2002-541915 Dec 2002 JP
2004-510471 Apr 2004 JP
2005500101 Jan 2005 JP
2005-512611 May 2005 JP
2007536989 Dec 2007 JP
2010-517623 May 2010 JP
2010-528761 Aug 2010 JP
2010536527 Dec 2010 JP
2012504031 Feb 2012 JP
2012152563 Aug 2012 JP
2014517720 Jul 2014 JP
2016-501104 Jan 2016 JP
6392778 Sep 2018 JP
2434604 Nov 2011 RU
1996002212 Feb 1996 WO
0018333 Apr 2000 WO
2000062716 Oct 2000 WO
0128453 Apr 2001 WO
0207795 Jan 2002 WO
2002024118 Mar 2002 WO
2002024119 Mar 2002 WO
0247468 Jun 2002 WO
2002045933 Jun 2002 WO
2002100301 Dec 2002 WO
2003007795 Jan 2003 WO
2003047468 Jun 2003 WO
03090834 Nov 2003 WO
2005112827 Dec 2005 WO
2006108090 Oct 2006 WO
2007016251 Feb 2007 WO
2008091589 Jul 2008 WO
2008097589 Aug 2008 WO
2008097592 Aug 2008 WO
2009029199 Mar 2009 WO
2009045332 Apr 2009 WO
2010037141 Apr 2010 WO
2010086460 Aug 2010 WO
2010057262 Jun 2011 WO
2011109450 Sep 2011 WO
2011109801 Sep 2011 WO
2011112706 Sep 2011 WO
2012004460 Jan 2012 WO
2012040643 Mar 2012 WO
2012065080 May 2012 WO
2012082952 Jun 2012 WO
2012110767 Aug 2012 WO
2012135603 Oct 2012 WO
2012167131 Dec 2012 WO
2013096854 Jun 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
2019067219 Apr 2019 WO
2019067220 Apr 2019 WO
2019074607 Apr 2019 WO
Non-Patent Literature Citations (53)
Entry
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US15/50113, dated Nov. 24, 2015, 14 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2018/050769, dated Nov. 27, 2018, 11 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2018/050779, dated Dec. 7, 2018, 14 pages.
Priority Document for U.S. Appl. No. 61/739,721, received by the International Bureau Jan. 3, 2014, 1 page.
Application Data Sheet, Drawings, Specification, Claims, and Abstract filed under U.S. Appl. No. 13/843,196 on Mar. 15, 2013, 52 pages.
European Search Report and Search Opinion Received for EP Application No. 18205790.1, dated Apr. 4, 2019, 7 pages.
European Search Report and Search Opinion Received for EP Application No. 15186981.5, dated Feb. 10, 2016, 5 pages.
European Search Report and Search Opinion Received for EP Application No. 17167842.8, dated Jun. 21, 2017, 5 pages.
European Search Report and Search Opinion Received for EP Application No. 17176507.6, dated Sep. 6, 2017, 5 pages.
European Search Report and Search Opinion Received for EP Application No. 17187595.8, dated Dec. 4, 2017, 5 pages.
European Search Report and Search Opinion Received for EP Application No. 17194473.9, dated Feb. 26, 2018, 9 pages.
European Search Report from EP16196687.4, dated Nov. 21, 2017, 5 pages.
International Preliminary Report on Patentability from PCT/US2015/045002, dated Mar. 2, 2017, 11 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US13/68390, dated Jul. 2, 2015, 12 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US13/71632, dated Jul. 2, 2015, 11 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US13/74962, dated Jul. 2, 2015, 9 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US13/75274, dated Jul. 2, 2015, 8 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US13/75380, dated Jul. 2, 2015, 7 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US13/76504, dated Jul. 2, 2015, 13 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US13/76688, dated Jul. 2, 2015, 12 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US14/68727, dated Jun. 16, 2016, 9 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2013/046389, dated Feb. 5, 2015, 13 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2013/051431, dated Feb. 5, 2015, 9 pages.
International Search Report and Written Opinion for PCT/US2014/068727 dated Mar. 2, 2015, corresponding to U.S. Appl. No. 14/561,148; 6 pages.
International Search Report and Written Opinion for PCT/US2014/068727 dated Mar. 2, 2015, corresponding to U.S. Appl. No. 14/561,148; 12 pages.
International Search Report and Written Opinion for PCT/US2015/050113, dated Nov. 24, 2015, 14 pages.
International Search Report and Written Opinion from PCT/US2018/053278, dated Dec. 19, 2018, 12 pages.
International Search Report and Written Opinion issued in PCT/US2018/050766, dated Mar. 11, 2019, 16 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2015/045002, dated Dec. 17, 2015, 13 pages.
International Search Report for PCT/US2013/046389 dated Jan. 21, 2014, corresponding to U.S. Appl. No. 13/797,633; 18 pages.
International Search Report for PCT/US2013/051431 dated Jan. 20, 2014, corresponding to U.S. Appl. No. 13/797,526; 6 pages.
International Search Report for PCT/US2013/068390 dated Apr. 29, 2014, corresponding to U.S. Appl. No. 13/835,988, 7 pages.
International Search Report for PCT/US2013/068780 dated Feb. 27, 2014, corresponding to U.S. Appl. No. 13/869,878, 4 pages.
International Search Report for PCT/US2013/071632 dated Apr. 28, 2014, corresponding to U.S. Appl. No. 13/841,334, 6 pages.
International Search Report for PCT/US2013/074962 dated Feb. 27, 2014, 4 pages.
International Search Report for PCT/US2013/075274 dated Feb. 27, 2014, corresponding to U.S. Appl. No. 13/843,196, I pages.
International Search Report for PCT/US2013/075274 dated Feb. 27, 2014, corresponding to U.S. Appl. No. 13/843,196, 5 pages.
International Search Report for PCT/US2013/075275 dated Jun. 11, 2014, corresponding to U.S. Appl. No. 13/843,196, 5 pages.
International Search Report for PCT/US2013/075380 dated Mar. 6, 2014, 5 pages.
International Search Report for PCT/US2013/076504 dated Apr. 28, 2014, corresponding to U.S. Appl. No. 14/133,491, 7 pages.
International Search Report for PCT/US2013/076688 dated Feb. 27, 2014, 5 pages.
Mano Thubrikar, “The Aortic Valve”, Chapter 1: Geometry of the Aortic Valve, CRC Press, Inc., Informa Healthcare, 2011, 40 pages.
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.
Clough, Norman E. Introducing a New Family of GORE ePTFE Fibers (2007), pp. 1-10.
Extended European Search Report issued in EP Application No. 18204192.1, dated May 29, 2019.
International Preliminary Report on Patentability issued in PCT/US2017/047174, dated Mar. 7, 2019, 9 pages.
International Search Report and Written Opinion from PCT/US2018/050768, dated Dec. 17, 2018, 12 pages.
International Search Report and Written Opinion from PCT/US2018/050786 dated Dec. 14, 2018, 13 pages.
International Search Report and Written Opinion issued in PCT/US2018/050764, dated Nov. 23, 2018, 13 pages.
International Search Report and Written Opinion issued in PCT/US2018/050778, dated Nov. 29, 2018, 11 pages.
International Search Report and Written Opinion received for PCT Application No. PCT/US2020/020550, dated Jun. 9, 2020, 12 pages.
Related Publications (1)
Number Date Country
20190247185 A1 Aug 2019 US
Provisional Applications (1)
Number Date Country
62038727 Aug 2014 US
Divisions (1)
Number Date Country
Parent 15502871 US
Child 16394149 US