Valved vascular prosthesis

Abstract

Various aspects of the present disclosure are directed to devices, systems, and methods including a valved conduit prosthesis. The valved conduit prosthesis can include at least one valve leaflet coupled to an outer surface of a conduit.

Description

[Technical field]

[0001] Field TECHNICAL FIELD This disclosure relates generally to prosthetic valves, and more particularly to devices, systems and methods that include a conduit having a valvular structure therein. [Background technology]

[0002] background Bioprosthetic heart valves have been developed that attempt to mimic the function and performance of natural valves. The flexible leaflets may be coupled to a relatively rigid frame or other support structure that supports the leaflets and provides dimensional stability during the implant procedure.

[0003] The leaflets require some means for securing them to a supporting structure. In operation, the leaflets open when the upstream fluid pressure exceeds the downstream fluid pressure and close when the downstream fluid pressure exceeds the upstream fluid pressure. The free ends of the leaflets coapt under the influence of the downstream fluid pressure to close the prosthetic heart valve and prevent downstream blood from flowing back through the prosthetic heart valve.

[0004] The durability of a prosthetic heart valve under the cyclic loading of leaflet opening and closing depends in part on the load distribution between the leaflets and the frame or supporting structure, and in particular on the attachment of the leaflets to the frame. Mechanical failure of the leaflets can occur, for example, at the attachment edges where flexible leaflets are supported by a relatively rigid frame. The cyclic loading of leaflet opening and closing can lead to material failure due to fatigue, creep or other mechanisms, depending in part on the leaflet material. Summary of the Invention

[0005] Abstract The described embodiments are directed to devices, systems and methods for valved conduit prostheses.

[0006] According to one example ("Example 1"), a valved conduit prosthesis includes a conduit having an outer surface and an inner surface defining a conduit lumen and a slot therethrough, and at least one valve leaflet having an outer portion coupled to the outer surface of the conduit and an inner portion disposed within the inner surface of the conduit such that the valve leaflet defines a valve structure such that the valve leaflet is operable as a one-way valve.

[0007] According to another example ("Example 2") in addition to Example 1, an exterior portion of the at least one leaflet is bonded to an exterior surface of the conduit by adhesive, thermal bonding, or chemical bonding.

[0008] According to another example ("Example 3") in addition to any one of Examples 1-2, the conduit does not have a bend.

[0009] According to another example ("Example 4") in addition to any one of Examples 1-2, the conduit has no mechanical bonds.

[0010] According to any one of Examples 1-4 plus another Example ("Example 5"), an exterior portion of the at least one leaflet is attached to an exterior surface of the conduit, the attachment being sutureless.

[0011] According to any one of Examples 1-5 plus another Example ("Example 6"), an exterior portion of the at least one leaflet is bonded to an exterior surface of the conduit by a layer of adhesive film.

[0012] According to another example ("Example 7") in addition to Example 6, the adhesive film is disposed around the conduit.

[0013] According to another example ("Example 8") in addition to any one of Examples 6-7, the device further includes a flexible film disposed around the conduit and the adhesive film.

[0014] According to another example ("Example 9") in addition to Example 8, the flexible film includes expanded polytetrafluoroethylene (ePTFE) and the adhesive film includes fluorinated ethylene propylene (FEP).

[0015] According to another example ("Example 10") in addition to any one of Examples 8-9, the device further includes a support frame coupled to the conduit by the flexible film.

[0016] According to another example ("Example 11") in addition to Example 10, the support frame is formed from polyetheretherketone (PEEK).

[0017] According to another example ("Example 12") in addition to any one of Examples 1-11, the valve further includes at least one radiopaque marker positioned adjacent to the at least one leaflet on an exterior surface of the conduit.

[0018] According to any one of Examples 1-12 plus another example ("Example 13"), the inner surface of the conduit is diametrically constant and free of macroscopic interruptions.

[0019] According to another example ("Example 14") in addition to any one of Examples 1-13, the at least one leaflet is disposed within the conduit at a longitudinal position along a length of the conduit, and the conduit is diametrically constant through adjacent proximal and distal portions of the conduit at the longitudinal position at which the at least one leaflet is disposed.

[0020] According to one example ("Example 15"), a valved conduit prosthesis includes a conduit having an inner surface, an outer surface, a proximal portion, and a distal portion, a leaflet attachment portion having an opening between the inner and outer surfaces of the conduit, and at least one leaflet having an attachment portion coupled to the outer surface of the conduit without mechanical modification of the inner or outer surfaces of the conduit to reduce thrombus formation within the conduit.

[0021] According to another example ("Example 16") in addition to any of Examples 1-15, the at least one valve leaflet includes three valve leaflets, the three valve leaflets being separated from one another by lands within the conduit.

[0022] According to any one of Examples 1-15 plus another Example ("Example 17"), the conduit includes lands separating the leaflets at their respective attachment portions and forming commissure gaps within an inner surface of the conduit between the three leaflets, wherein the commissure gaps provide a retrograde flow path when the valve is in a closed position.

[0023] According to any one of Examples 15-17 plus another Example ("Example 18"), the attachment section is attached to the outer surface of the conduit by adhesive, thermal bonding, or chemical bonding.

[0024] According to another example ("Example 19") in addition to any one of Examples 1-18, the attachment section includes a first portion and a second portion, the first portion being attached to a proximal portion of the outer surface of the conduit, and the second portion being attached to a distal portion of the outer surface of the conduit.

[0025] According to any one of Examples 15-19 plus another example ("Example 20"), the leaflet attachment portion is a portion of a conduit, and the leaflet attachment portion is denser than an adjacent portion of the conduit.

[0026] According to one example ("Example 21") in addition to any one of Examples 15-20, the valved conduit prosthesis also includes a directional indicator on an outer surface of the conduit to indicate the direction of blood flow within the conduit when in an open state.

[0027] According to one example ("Example 22"), a method of reducing thrombus formation resulting from replacement of a native pulmonary valve or a previously implanted pulmonary valve conduit prosthesis when partial or complete reconstruction of the right ventricular outflow tract and / or main pulmonary artery is desired, comprising: 1. A method comprising: providing a valved conduit prosthesis comprising a synthetic conduit having a distal end, a proximal end, an interior, an exterior and a leaflet attachment portion, and at least one flexible synthetic leaflet having a portion exterior to the conduit and a portion interior to the conduit, wherein the leaflet portion exterior to the conduit is coupled to the exterior of the conduit at an attachment portion, the attachment portion of the conduit being unperforated, and surgically implanting the valved conduit prosthesis.

[0028] According to one example ("Example 23"), a method for replacing a native pulmonary valve or a previously implanted pulmonary valve conduit prosthesis when partial or complete reconstruction of the right ventricular outflow tract and / or main pulmonary artery is desired, comprising: The method includes providing a valved conduit prosthesis, the valved conduit prosthesis comprising a synthetic conduit and at least one flexible synthetic valve leaflet coupled to the synthetic conduit, the synthetic conduit having been rinsed with saline and not pre-clotted, and surgically implanting the valved conduit prosthesis.

[0029] According to one example ("Example 24"), a method for replacing a native pulmonary valve or a previously implanted pulmonary valve conduit prosthesis when partial or complete reconstruction of the right ventricular outflow tract and / or main pulmonary artery is desired, comprising: The method includes providing a saline-rinsed, non-preclotted valved conduit prosthesis, the valved conduit prosthesis comprising a non-biologic conduit and at least one flexible polymeric non-biologic valve leaflet attached to the non-biologic conduit, identifying inflow and outflow portions of the valved conduit prosthesis, accessing the intended location relative to the coronary artery to ensure there is no risk of coronary artery compression during the implant procedure, optionally trimming the inflow and / or outflow conduits to a length suitable for the implant procedure while applying appropriate tension, and attaching the valved conduit prosthesis.

[0030] According to one example ("Example 25"), a package insert for a valved conduit prosthesis includes a support structure configured to fold to form one or more supports and to be inserted into the valved conduit prosthesis to support one or more valve leaflets within the valved conduit prosthesis.

[0031] According to one example ("Example 26"), a method of treating aortic valve disease by replacing the aortic root includes providing a valved conduit prosthesis of any of the examples above and surgically implanting the valved conduit prosthesis.

[0032] According to one example ("Example 27"), the method of Example 26 includes identifying inflow and outflow portions of the conduit, accessing the intended location with respect to the anatomical structure, optionally trimming the inflow and outflow portions of the conduit to a length suitable for the implant procedure, optionally tapering the inflow end outwardly or optionally everting and rolling the inflow portion towards the valve leaflet structure to define a sewing cuff, cutting the ascending aorta, coupling the inflow portion of the valved conduit prosthesis to the left ventricle adjacent to or in place of the resected aortic valve, and coupling the outflow portion of the valved conduit prosthesis to the resected ascending aorta.

[0033] According to one example ("Example 28"), the method of Example 27 further includes coupling a coronary artery to an outflow portion of the conduit 102 to establish a flow path from the conduit lumen to the coronary artery.

[0034] According to one example ("Example 29"), the method of Example 28 further includes coupling the coronary artery to a curve defined by the outflow segment.

[0035] According to one example ("Example 30") in addition to any of Examples 1-29, the one or more leaflets comprise a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, and optionally, on at least a portion of the composite material, a TFE-PMVE copolymer including 27 to 32 weight percent perfluoromethylvinylether and 73 to 68 weight percent tetrafluoroethylene, respectively, and optionally, the elastomer or elastomeric material includes a TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.

[0036] According to one example ("Example 31") in addition to any of Examples 1-30, the conduit has an inflow portion defining an inflow end and an outflow portion defining an outflow end, and the at least one leaflet is operable to open to allow flow from the inflow end of the conduit through the outflow end under an antegrade flow condition, and to close to restrict flow from the outflow end from passing through the inflow end under a retrograde flow condition.

[0037] According to one example ("Example 32") in addition to any of Examples 1-31, the at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, and optionally, on at least a portion of the composite material, a TFE-PMVE copolymer including 27 to 32 weight percent perfluoromethylvinylether and 73 to 68 weight percent tetrafluoroethylene, respectively, and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.

[0038] According to any of Examples 1-32 plus one Example ("Example 33"), the outflow portion defines a curve adjacent the at least one leaflet.

[0039] According to one example ("Example 34") in addition to Example 33, the curved portion is operable for surgical attachment of a blood vessel and / or a coronary artery.

[0040] According to any one of Examples 1-34 plus an example ("Example 35"), the inflow end defines an outward taper or is operable to be outwardly tapered.

[0041] According to any one of Examples 1-34 plus one Example ("Example 36"), the inflow portion is operable to be everted outward and rolled toward the valve structure to define a sewing cuff.

[0042] According to one example ("Example 37"), a valved conduit prosthesis includes a conduit having an inner surface, an outer surface, a proximal portion and a distal portion defining a conduit lumen, a leaflet attachment portion having an opening between the inner and outer surfaces of the conduit, and at least one leaflet having an attachment section attached to the outer surface of the conduit, the at least one leaflet defining a valve structure.

[0043] According to one example ("Example 38") in addition to Example 37, the at least one leaflet includes three leaflets, the three leaflets being separated from one another within the conduit by commissure gaps.

[0044] According to one example ("Example 39") in addition to Example 38, the conduit includes lands separating the leaflets at their respective attachment sections to form commissure gaps between three leaflets within an interior surface of the conduit.

[0045] According to any one of Examples 37-39 plus one Example ("Example 40"), the attachment section is attached to the exterior surface of the conduit by adhesive, thermal bonding, or chemical bonding.

[0046] According to any one of Examples 37-40 plus one Example ("Example 41"), the leaflet attachment portion is a portion of the conduit, and the leaflet attachment portion is denser than a remainder of the conduit.

[0047] According to one example ("Example 42") in addition to any one of Examples 37-41, the conduit has an inflow portion defining an inflow end and an outflow portion defining an outflow end, and the at least one leaflet coupled to the conduit is operable to open to allow flow from the inflow end of the conduit through the outflow end under an antegrade flow condition, and to close to restrict flow from the outflow end from flowing through the inflow end of the conduit under a retrograde flow condition.

[0048] According to one example ("Example 43") in addition to any one of Examples 37-42, the at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores, and optionally, on at least a portion of the composite material, a TFE-PMVE copolymer including 27 to 32 weight percent perfluoromethylvinylether and 73 to 68 weight percent tetrafluoroethylene, respectively, and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.

[0049] The foregoing examples are merely examples and should not be read as limiting or narrowing the scope of any of the inventive concepts otherwise provided by this disclosure. [Brief description of the drawings]

[0050] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description, serve to explain the principles of the disclosure.

[0051] [Figure 1A] FIG. 1A is a side view of an exemplary valved conduit prosthesis, according to one embodiment.

[0052] [Figure 1B]FIG. 1B is an axial view of the valve structure in a closed configuration according to the embodiment of FIG. 1A.

[0053] [Figure 1C] FIG. 1C is an axial view of the valve structure in an open configuration according to the embodiment of FIG. 1A.

[0054] [Diagram 2] FIG. 2 is a side view of another valved conduit prosthesis, according to another embodiment.

[0055] [Diagram 3] FIG. 3 is a cross-sectional view of another valved conduit prosthesis, according to another embodiment.

[0056] [Figure 4A] FIG. 4A is a side view of a conduit including the cut pattern of the conduit when used in a valved conduit prosthesis, according to one embodiment.

[0057] [Figure 4B] FIG. 4B is a side view of a conduit including a cut pattern for the conduit when used in a valved conduit prosthesis according to another embodiment.

[0058] [Figure 4C] FIG. 4C is a side view of a conduit including a cut pattern for the conduit when used in a valved conduit prosthesis according to another embodiment.

[0059] [Diagram 5] FIG. 5 is a valve leaflet that may be used in a valved conduit prosthesis, according to one embodiment.

[0060] [Figure 6A] FIG. 6A is an illustration of an exemplary process for attaching a valve leaflet to a conduit according to one embodiment.

[0061] [Figure 6B]FIG. 6B is an illustration of another exemplary process for attaching the leaflets to a conduit, according to the embodiment of FIG. 6A.

[0062] [Figure 6C] FIG. 6C is a diagram of another exemplary process for attachment of the leaflets to a conduit in accordance with the embodiment of FIGS. 6A-B.

[0063] [Figure 7] FIG. 7 is a perspective view of a valved conduit prosthesis as used in an aortic root replacement procedure, according to one embodiment.

[0064] [Figure 8] FIG. 8 is a cross-sectional view of a valved conduit prosthesis according to another embodiment.

[0065] [Figure 9] FIG. 9 is a cross-sectional view of a valved conduit prosthesis according to another embodiment.

[0066] [Figure 10A] FIG. 10A is a diagram of a packaging insert for a valved vascular prosthesis in an unfolded configuration, according to one embodiment.

[0067] [Figure 10B] FIG. 10B is a side view of the package insert shown in FIG. 10A in a folded configuration.

[0068] [Figure 10C] FIG. 10C is a top view of the package insert shown in FIGS. 10A-B in a folded configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0069] Detailed Description Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0070] The embodiments herein may be described in conjunction with various principles and beliefs, but the described embodiments should not be bound by theory. For example, the embodiments are described herein in conjunction with a valved conduit prosthesis, which is a prosthetic device. However, embodiments within the scope of the present disclosure may be applied to any valved conduit prosthesis, valve structure, or mechanism of similar structure and / or function. Additionally, embodiments within the scope of the present disclosure may be applied to non-cardiac applications.

[0071] The term "conduit," as used herein, is defined as a tubular member having a lumen operable to pass a fluid therethrough and having walls that are impermeable to fluid movement.

[0072] The terms "valved conduit" and "valved conduit prosthesis", as used herein, are used interchangeably and are defined as a conduit having a valve structure coupled to and contained within the conduit for use in coronary or vascular procedures.

[0073] The term "valve structure" as used herein is defined as one or more separate leaflets or leaflet constructs having multiple leaflets joined together that function as a one-way valve.

[0074] The term "leaflet construct," as used herein, is defined as a valve structure that includes multiple leaflets joined together with commissure regions between each leaflet.

[0075] The term "valved conduit assembly," as used herein, is defined as a shortened length of valved conduit that can be placed within a primary conduit.

[0076] The term "film" as used herein refers to a sheet comprising a single material such as, but not limited to, an expanded (expanded, expanded, stretched or foamed) fluoropolymer.

[0077] The term "composite material" as used herein refers to a combination of a membrane, such as, but not limited to, an expanded fluoropolymer, and an elastomer or elastomeric material, such as, but not limited to, a fluoroelastomer. The elastomer or elastomeric material can be contained within the porous structure of the membrane, coated on one or both sides of the membrane, or a combination of being coated on and contained within the porous structure of the membrane.

[0078] The term "laminate" as used herein refers to multiple layers of films, composites, or other materials, such as elastomers or elastomeric materials, and combinations thereof.

[0079] The term "film," as used herein, refers generically to one or more of a membrane, a composite, or a laminate.

[0080] The term "biocompatible material," as used herein, generally refers to any material that has biocompatible properties, including, but not limited to, synthetic materials, such as biocompatible polymers, or biological materials, such as, but not limited to, bovine pericardium.

[0081] The term "coupled," as used herein, means coupled, connected, attached, adhered, affixed, or bonded, whether directly or indirectly, permanently or temporarily.

[0082] Embodiments herein include various devices, systems and methods for a conduit having a valve structure operable as a prosthetic valve that can be used, such as, but not limited to, to replace a pulmonary valve and a portion of a corresponding pulmonary artery. The valve structure can include one or more leaflets operable as a one-way valve with a conduit defining a conduit lumen. The leaflets respond to a fluid pressure differential by opening to allow flow and closing to occlude the conduit lumen and prevent flow.

[0083] The embodiments herein include various devices, systems, and methods for a conduit having a valve structure operable as a prosthetic valve that can be used, such as to replace an aortic valve and a portion of the aorta, such as, but not limited to, the ascending aorta. The valve structure can include one or more leaflets operable as a one-way valve with a conduit defining a conduit lumen. The leaflets respond to a fluid pressure differential by opening to allow flow and closing to occlude the conduit lumen and prevent backflow. The conduit is operable to be surgically coupled, such as, but not limited to, using sutures at a proximal end of the conduit, to a portion of the ascending aorta at a distal end of the conduit. In other embodiments, the conduit is also operable to surgically attach one or more coronary arteries thereto to establish blood flow thereto.

[0084] 1A is a side view of a valved conduit prosthesis 100, according to one embodiment. Valved conduit prosthesis 100 includes a conduit 102 having a valve structure 104 disposed within the conduit 102. Conduit 102 includes an inflow end 213 and an outflow end 215 such that the valve structure 104 is operable to allow unidirectional flow from the inflow end 213 to the outflow end 215.

[0085] Valved conduit prosthesis 100 may be used, in a non-limiting example, to replace at least a portion of the aortic valve and ascending aorta. In one non-limiting example, valved conduit prosthesis 100 may be indicated for correction or reconstruction of the aortic root and aortic valve, i.e., aortic root replacement, in pediatric patients. Valved conduit prosthesis 100 may also be applied for replacement of previously implanted allografts or valved conduits that have become dysfunctional or inadequate.

[0086] The valved conduit prosthesis 100 can be used, in a non-limiting example, as a shunt to connect the right ventricle to the pulmonary artery after the Norwood procedure, which is frequently performed to treat hypoplastic left heart syndrome. In one non-limiting example, the valved conduit prosthesis 100 can be applied to correct or reconstruct the right ventricular outflow tract (RVOT) in pediatric patients. Such reconstruction can be indicated for congenital heart disease such as tetralogy of Fallot, dextro-truncal transposition of the aorta, pulmonary atresia with an intact ventricular septum, or aortic valve disease. The valved conduit prosthesis 100 can also be applied to replace previously implanted allografts or valved conduits that have become dysfunctional or inadequate. Additionally, the valved conduit prosthesis 100 can have applications in treating a broader range of cardiac disorders, including other regions of the heart.

[0087] In general, the term "distal" is used in this disclosure to refer to the outflow end 215 (distal end) or outflow direction of the valved conduit prosthesis 100, and the term "proximal" is used to refer to the inflow end 213 of the valved conduit prosthesis 100. Antegrade or forward flow is the flow of fluid from the inflow end 213 to the outflow end 215, and retrograde flow, also called reverse flow when leaking through a closed valve structure 104, is the flow of fluid from the outflow end 215 to the inflow end 213.

[0088] In certain embodiments, the inner surface 110 of the conduit 102 is diametrically constant, as shown in Figures 1B and 3. Additionally, the leaflets 106 can be disposed within the conduit 102 at longitudinal positions along the length of the conduit 102 (e.g., as shown in Figure 1A), with the conduit 102 being diametrically constant at the longitudinal positions at which the leaflets 106 are disposed and through adjacent proximal and distal portions of the conduit 102.

[0089] 1B and 1C show axial views of the valve structure 104 in closed and open configurations, respectively, according to the embodiment of FIG. 1A. The valve structure 104 includes leaflets 106 extending from the inner surface 102 of the conduit 102 into the interior of the conduit 102. The valve structure 104 is defined as a leaflet construct having one or more separate leaflets 106 or multiple leaflets 106 joined together to function as a one-way valve. Although three leaflets 106 are shown in FIG. 1B and FIG. 1C, the valve structure 104 can include one, two, three, four or more leaflets 106. As shown in FIG. 1B, the leaflets 106 close toward the center 108 of the conduit 102 in the closed configuration. In the open configuration, blood can flow through the valve structure 104 and the leaflets 106 are pushed toward the inner surface 110 of the conduit 102, as shown in FIG. 1C. According to one embodiment, the leaflets 106 may be coupled to the conduit 102 as a valve structure 104 such that the inner surface 110 of the conduit 102 has a smooth interior with a consistent inner diameter from the inflow end 213 to the outflow end 215, interrupted only by the leaflets 106 themselves. As described below, the leaflets 106 are coupled to the conduit 102 by tabs 542 coupled to the outer surface 320 of the conduit 102, while the leaflet berry 125 extends from the conduit inner wall into the conduit lumen 122.

[0090] As shown in Figures 1B and 1C, a commissure gap 114 is located at each commissure 116 between a pair of leaflets 106. The commissure 116 is the location on the conduit inner surface 110 of the closest proximity of the pair of leaflets 106 at the leaflet free ends 107, as shown in Figures 4A-4C, as the lands 112 that define the commissure gap 114. The commissure gap 114 allows retrograde flow through the conduit 102 when the leaflets 106 are closed. Retrograde flow can reduce the opportunity for blood to stagnate behind the leaflets 106, which can lead to clot formation. The commissure gap 114 is sized such that leakage due to retrograde flow is minimized and does not otherwise increase the load on the patient's heart to pump blood through the conduit 102. The commissure gaps 114, as shown in detail in Figures 4A-4C, relate to the lands 112 in the conduit 102, ie, the spaces between adjacent slits 434 in closest proximity.

[0091] 2 is a diagram of another valved conduit prosthesis 100 according to another embodiment. The valved conduit prosthesis 100 includes a conduit 102 and a valve structure 104. The conduit 102 includes an inflow portion 212 that defines an inflow end 213 and an outflow portion 214 that defines an outflow end 215. As indicated by the arrows on the conduit 102, the valve structure 104 is configured to allow blood flow through the conduit 102 from the inflow portion 212 to the outflow portion 214 and to prevent blood flow from the outflow portion 214 to the inflow portion 212. The arrows can be design features printed on the conduit 102 to indicate the direction of blood flow within the conduit 102 and provide direction to the physician for the proper implant procedure. The arrows (directional indicators) can be of many different shapes, sizes, lengths, or include other considerations.

[0092] 1B, the valve structure 104 includes one or more leaflets 106. The leaflets 106 are coupled to the conduit 102 and in combination with the conduit 102 define the valve structure 104. The leaflets 106 are coupled to the outer surface 320 of the conduit 102 by suitable means such as, but not limited to, adhesives, thermal bonding, and chemical bonding. According to one embodiment, the leaflets 106 are coupled, attached, adhered, affixed, or bonded to the conduit 102 by an adhesive film 216, as shown in FIG.

[0093] The adhesive film 216 can be a continuous or discontinuous layer wrapped around the conduit 102. The adhesive film 216 can be disposed or wrapped around the conduit 102 at the densified portion 604 (discussed with reference to FIG. 3) and / or beyond the densified portion 604 of the conduit 102, as long as it is within the valve region 350 of the conduit 102 to bond the leaflets 106 to the exterior surface of the conduit 102. In other embodiments, the adhesive film 216 can be disposed at the valve region 350 of the conduit 102, and beyond the valve region 350 of the conduit 102, and in some embodiments, can cover the entire conduit 102. The adhesive film 216 can seal the slit 434 through which blood leaks. The adhesive film 216 can hold together two conduits that are butt-joined at the leaflets, as illustrated in FIGS. 4B and 4C as a first conduit 102a and a second conduit 102b.

[0094] As shown in FIG. 3, bonding or attaching the leaflets to the outer surface 320 of the conduit 102, for example by adhesive, thermal bonding or chemical bonding, maintains a smooth inner surface 318 and a consistent conduit inner diameter, and maximizes the effective valve orifice area (EOA) compared to attachment configurations that affect the profile of the inner surface 318.

[0095] 3 is a cross-sectional view of a valved conduit prosthesis 100, according to one embodiment. The valved conduit prosthesis 100 includes a conduit 102 having an inner surface 318, an outer surface 320, a proximal (or inflow) portion 212, and a distal (or outflow) portion 214. The conduit 102 includes a leaflet attachment portion 322 having an opening 324 between the inner surface 318 and the outer surface 320 of the conduit 102. As described below, the opening 324 can correspond to a slit 434 as shown in FIGS. 4A-4C, thereby resulting in a discontinuous slit 434, or can result in a complete separation of the conduit 102 into a first conduit 102a and a second conduit 102b as shown in FIGS. 4A and 4C. The leaflet attachment portion 322 can be an integral part of the conduit 102.

[0096] The valved conduit prosthesis 100 also includes leaflets 106 that enter the conduit 102 and extend towards the center 108 of the conduit. As shown in FIG. 3, the leaflets 106 are coupled to the outer surface 320 of the conduit 102 via tabs 542. The leaflets 106 include a portion that is disposed outside and within the conduit 102 via openings 324, as shown in FIG. 3, and the leaflet belly is defined as the portion of the leaflet that extends from the inner surface 318 into the conduit 102. According to this embodiment shown as an example, the leaflets 106 are coupled to the outer surface 320 of the conduit 102 by an adhesive film 216. The adhesive film 216 may be overlaid or overlapped on the tabs 542 and / or on the slits 434 or openings 324. Other means of coupling are contemplated, such as, but not limited to, thermal, adhesive and mechanical coupling. The adhesive film 216 may be disposed within the boundaries of the leaflet attachment portion 322. Further, the leaflet attachment portion 322 may be densified or have material properties that are denser compared to the proximal (or inflow) portion 212 and the distal (or outflow) portion 214 of the conduit 102 and are identified as the dense portion 604.

[0097] The leaflet attachment portion 322 may be densified and / or stiffened relative to the remainder of the conduit 102 for certain purposes. By way of example, and not by way of limitation, a densified attachment portion 322 may be provided so that the conduit 102 retains its shape at the valve region 350 during handling and use. By way of other example, and not by way of limitation, a densified attachment portion 322 may be provided to provide a smoother surface texture and / or reduced porosity to prevent flow disturbances and / or prevent tissue or pannus ingrowth. Densification refers to the process of selectively making a material more dense at selected locations, such as by application of heat and / or pressure and / or imbibing an elastomer or elastomeric material into the pores. In certain embodiments, the conduit 102 is formed from expanded polytetrafluoroethylene (ePTFE). In ePTFE materials, which can be relatively porous, the densification process reduces the porosity and / or makes the areas stiffer.

[0098] The valved conduit prosthesis 100 may also include a flexible film 326 disposed around the conduit 102 and the adhesive film 216. The flexible film 326 may, in certain embodiments, include one or more layers of the flexible film 326. The flexible film 326 may be wrapped multiple times around the conduit 102 and the adhesive film 216. The flexible film 326 may be wrapped as needed to enhance the strength of the conduit 102 and / or the attachment of the leaflets 106 to the conduit 102, and / or to bond the tabs 542, and / or to seal the slits 434 or openings 324 from leakage, and / or to hold together two conduits that are butt-joined at the leaflets 106, for example, as depicted in Figures 4B and 4C as a first conduit 102a and a second conduit 102b. The adhesive film 216 can be disposed or wrapped around the conduit 102 at and / or beyond the leaflet attachment portion 322 (e.g., as discussed with reference to FIG. 3 ) of the conduit 102, so long as it is within the valve region 350 of the conduit 102 to couple the leaflets 106 to the outer surface 320 of the conduit 102. In other embodiments, the adhesive film 216 can be disposed at and beyond the valve region 350 of the conduit 102, and in some embodiments, can cover the entire conduit 102.

[0099] The flexible film 326 increases the longitudinal tensile strength of the conduit 102, for example, by adding column strength to the conduit 102. The flexible film 326 may be used, for example, to ensure that the leaflets 106 are secured to the outer surface 320 of the conduit 102. In certain embodiments, as described above, the conduit 102 can be ePTFE. Particularly suitable are ePTFE vascular grafts, which have stretchable / elastic behavior, as they provide variable length with resistance to bending / kinking. In this regard, the outer surface 320 of the conduit 102 can stretch to conform to the anatomy without kinking the inner surface 318 (luminal flow surface) and thus the conduit lumen 122 of the conduit 102. The flexible film 326 can also be ePTFE, where the adhesive film 216 is fluorinated ethylene propylene (FEP). The flexible film 326 and the adhesive film 216 may be used in combination to bond (eg, thermally) the leaflets 106 to the conduit 102 .

[0100] In certain embodiments, the valved conduit prosthesis 100 may also include a support frame 328 coupled to the outer surface 320 of the conduit 102 by a flexible film 326 or by other means such as heat, adhesive, mechanical, and frictional means. The support frame 328 may prevent or otherwise reduce compression of the conduit 102 and valve structure 104 due to anatomical compression and / or manipulation forces. Additionally, the support frame 328 may be formed from polyetheretherketone (PEEK) in certain embodiments. In these examples, the support frame 328 is not radiopaque, and therefore allows the physician to better view the location of the leaflets 106 and leaflet attachment portions 322, as compared to when the support frame 328 is formed from other materials that impede visualization. Visualization of the leaflets 106 and / or leaflet attachment portions 322 may enhance the physician's ability to accurately locate and position the conduit 102 at a target location. In another example, the support frame 328 is formed from a radiopaque material as an aid in positioning or post-operative confirmation of the implant procedure. In another example, the support frame 328 is a metal, such as stainless steel, which can provide crush resistance while allowing the outer surface 320 of the conduit 102 to have a lower profile (e.g., thinner) as shown in FIG. 11, compared to other materials.

[0101] The support frame 328 may or may not be radiopaque. In certain instances, the valved conduit prosthesis 100 may include one or more radiopaque markers 330 to aid in visualizing the valve region 350 of the conduit 102 after the procedure under fluoroscopy. The one or more radiopaque markers 330 may be positioned adjacent to the leaflets 106 on the outer surface 320 of the conduit 102. In certain embodiments, as shown in FIG. 3, the valved conduit prosthesis 100 may include radiopaque markers 330 on either longitudinal side of the leaflets 106 and leaflet attachment portions 322, and may also be positioned in radial alignment with the leaflets 106, such as, but not limited to, at the commissures 116, to aid in flow visualization and analysis. In this manner, the physician has markers to position or locate the leaflets 106 and leaflet attachment portions 322, more specifically, at the target location. In certain embodiments, the radiopaque marker 330 is a continuous or discontinuous ribbon of radiopaque material (eg, gold) wrapped or disposed around the conduit 102 .

[0102] FIG. 4A is a diagram of a cut pattern 432 for the conduit 102 when used in the valved conduit prosthesis 100 according to an embodiment in which a single conduit component is utilized. The cut pattern 432 includes a number of separate slits 434 (e.g., creating the opening 324 shown in FIG. 3). The slits 434 correspond to the number of leaflets 106 shown in FIG. 3 that are coupled to the conduit 102. As shown in FIG. 4A, the multiple slits 434 defined by the cut pattern 432 are not interconnected. Thus, the conduit 102 is not separated into multiple pieces during assembly and a single conduit component is utilized. Although two slits 434 are shown in FIG. 4A, the cut pattern 432 may have additional slits (e.g., three slits as in a three leaflet tricuspid valve, four slits, etc.). The slits 434 may be formed by laser cutting, hand cutting, or other similar methods. In the embodiment shown in Figures 4A-4C, each slit 434 defines a parabolic shape and the corresponding leaflet 106 has a parabolic shape that penetrates the conduit 102 at the inner surface 318. When the valve region 350 is cut longitudinally and visualized lying open and flat, it defines three sides of an isosceles trapezoid to define a leaflet 106 having a flat base and two straight sides. Tabs 542 and 544, shown in Figure 5, can be passed through the slits 434 from inside the conduit 102 and attached to the outer surface 320, as shown in Figure 6C.

[0103] The slits 434 are separated by lands 112 where two leaflets 106 are in close proximity to define a commissure 116. As described above, the slits 434 correspond to the number of leaflets (not shown) coupled to the conduit 102. The lands 112 correspond to the commissures 116 (shown in FIGS. 1B and 1C), i.e., the separation between the leaflets 106 in the conduit 102. When the leaflets 106 are in a closed position (e.g., the valve structure is closed), a space, i.e., the commissure gap 114, exists between the leaflets 106, as shown in FIG. 1B. Similarly, when the leaflets 106 are in an open position, a space, i.e., the commissure gap 114, exists between the leaflets 106, as shown in FIG. 1C. The slits 434 and lands 112 correspond to the number of leaflets coupled to the conduit 102. The commissure gap 114 allows blood to wash out the area behind the leaflets 106 when the leaflets are in a closed position. Retrograde or backflow through the commissural gap 114 reduces the opportunity for blood to become stagnant behind the leaflets 106, which can lead to thrombus formation. The commissural gap 114 is sized so that the resulting retrograde flow is minimal and does not otherwise increase the strain on the patient's heart to pump blood through the conduit 102. The commissural gap 114 also increases fluid flow at the commissures when the leaflets 106 are in the open position, thereby preventing, for example, but not by way of limitation, the trapping of blood between two closely opposing leaflet surfaces that may occur if the commissural gap 114 is not provided.

[0104] 4B is a diagram of a cut pattern 436 for the conduit 102 when used in the valved conduit prosthesis 100, according to one embodiment. The cut pattern 436 includes a plurality of separate slits 434, the number of slits 434 corresponding to the number of valve leaflets (not shown) to be coupled to the conduit 102. The cut pattern 436 also includes a side cut 438 in the conduit 102 where the conduit 102 may be divided into two conduit components for assembly, i.e., a first conduit 102a and a second conduit 102b, as shown in FIG. 4B. The side cut 438 is located near, adjacent to, or at the midpoint of a longitudinal portion of the slit 434. The side cut 438 and slits 434 may be formed by laser cutting, hand cutting, or other similar methods. Although two slits 434 are shown in FIG. 4B, the cutting pattern 436 can have additional slits (e.g., three slits, four slits, etc. for a valve with three leaflets 106, such as in a tricuspid valve).

[0105] The slits 434 and side cuts 438 correspond to the number of leaflets that are coupled to the conduit 102. As in FIG. 4A, the slits 434 are separated by lands 112. The lands 112 correspond to the separation (e.g., at the commissures) between the leaflets 106 in the conduit 102. When the leaflets 106 are closed (e.g., when the valve is closed), there is a space between the leaflets, i.e., the commissure gap 114, as shown in FIG. 1. The commissure gap 114 allows blood to wash out the area behind the leaflets when they are in the closed position, as previously discussed. Retrograde flow reduces the opportunity for blood to stagnate behind the leaflets 106, which can lead to the formation of blood clots. The commissure gap 114 is sized so that the resulting retrograde flow is minimal and does not otherwise increase the load on the patient's heart to pump blood through the conduit 102. The commissure gap 114 can also increase fluid flow at the commissures when the leaflets 106 are in the open position, thereby, for example, but not by way of limitation, preventing the trapping of blood between two closely opposing leaflet surfaces that can occur if the commissure gap 114 is not provided.

[0106] FIG. 4C is an illustration of another exemplary cutting pattern 440 for the conduit 102 when used in a valved conduit prosthesis, according to one embodiment.

[0107] The cutting pattern 440 includes a plurality of separate slits 434 with a number of slits corresponding to the number of leaflets (not shown) to be coupled to the conduit 102. The cutting pattern 440 also includes side cuts 438 that are also cut in the conduit 102 to allow the conduit 102 to be cut into two conduit components for assembly, as shown in FIG. 4C, defining a first conduit 102a and a second conduit 102b. The side cuts 438 and slits 434 may be formed by laser cutting, hand cutting, or other similar methods. Although two slits 434 are shown in FIG. 4B, the cutting pattern 440 may have additional slits (e.g., three slits, four slits, etc. for a tricuspid valve).

[0108] As discussed above, the slits 434 and lateral cuts 438 correspond to the number of leaflets that are coupled to the conduit 102. As in Figure 4A, the slits 434 are separated by lands 112. The lands 112 correspond to the commissure gaps 114, which are the separation between the leaflets in the conduit 102 when the valve is closed (e.g., maintaining the commissure gaps 114 when the leaflets are in the closed position).

[0109] FIG. 5 is a leaflet 106 that may be used in an embodiment of the valved conduit prosthesis 100, according to one embodiment. As shown in FIG. 5, the leaflet 106 may include a number of tabs 542 extending from and defining the leaflet belly 125. The tabs 542 may be formed by cutting slits in the edge of the leaflet 106. The leaflet 106 is formed from a thin sheet of material, as discussed below. As shown in further detail with reference to FIGS. 6A-C, the tabs 542 may be used to couple the leaflet 106 to the outer surface 320 of the conduit 102, as also shown in FIG.

[0110] In certain embodiments, the leaflets 106 include alignment tabs 544, which are tabs 544 adjacent the free ends of the leaflets. The alignment tabs 544 are formed in the same manner as the tabs 542. The alignment tabs 544, when present on the leaflets 106, are used to interface with the conduit 102 and aid in aligning the leaflets 106 at the commissures 116 for attachment to the conduit 102.

[0111] Figure 6A illustrates an exemplary process for attaching the leaflets 106 to the conduit 102, according to one embodiment. For ease of illustration, the outflow portion 214 of the conduit 102 is shown in Figure 6A. However, as discussed with reference to Figure 4A, the conduit 102 and the leaflets 106 may be joined together without separating the conduit 102 into sections.

[0112] The leaflets 106 are aligned with the slits 434 within the conduit 102. As discussed above, multiple leaflets 106 can be coupled to the conduit 102. For ease of illustration, FIGS. 6A-C show attachment of a single leaflet 106 to the conduit 102. In certain embodiments, the conduit 102 includes an alignment line 646 that extends longitudinally along the conduit 102. The alignment line 646 facilitates alignment of the leaflets 106 within the conduit 102. In certain embodiments, the leaflets 106 include alignment tabs 544 that are positioned against the alignment line 646 to ensure proper shape and alignment of the leaflets 106 within the conduit 102. In other embodiments, the slits 434 at the commissures 116 are used to assist in alignment of the leaflets 106 to the conduit 102.

[0113] Once the leaflets 106 are aligned with the slits 434, the tabs 542 may be folded onto the outer surface 306 of the conduit 102. As shown in FIG. 6B, the alignment tabs 544 may be folded to align with the alignment lines 646.

[0114] As shown in FIG. 6C, the tabs 542 can be folded in different directions. Alternating tabs 542 can be folded, for example, against the outer surface 320 of the proximal (or inflow) portion 212 and the distal (or outflow) portion 214 of the conduit 102. The tabs 542 (and alignment tabs 544) can be attachment sections of the leaflets 106, which can be bonded to the outer surface 320 of the conduit 102, for example, but not limited to, by adhesive, thermal bonding, or chemical bonding (e.g., as described in detail above with reference to FIGS. 6A-6C). The tabs 542 of the leaflets 106 extend through slits 434 (e.g., as shown in FIG. 3) in the conduit 102 defined between the proximal (or inflow) portion 212 and the distal (or outflow) portion 214. The remaining portion of the leaflet 106 , the leaflet belly 125 , extends into the conduit lumen 122 of the conduit 102 and is operable to function as a valve within the valved conduit prosthesis 100 .

[0115] The valved conduit prosthesis discussed herein is used in surgical procedures to replace diseased anatomical structures. Prior to the implantation procedure, the valved conduit prosthesis can be rinsed with saline and does not require pre-clotting. According to one method of treatment, the valved conduit prosthesis is used as a replacement for the aortic valve and a portion of the ascending aorta, such as in an aortic root replacement. The implantation procedure of the valved conduit prosthesis includes identifying the inflow and outflow portions of the conduit, accessing the intended location with respect to the anatomy, and trimming the inflow and / or outflow conduits to an appropriate length for the implantation procedure, possibly under moderate tension. The ascending aorta is cut and the inflow portion and / or inflow end of the valved conduit prosthesis is sutured or otherwise attached to the left ventricle adjacent to or replacing the resected aortic valve. The outflow portion and / or outflow end of the valved conduit prosthesis is sutured to the cut ascending aorta. The coronary arteries can remain in the ascending aorta or can be sutured to the outflow portion of the conduit, providing a flow path from the conduit lumen to the coronary arteries.

[0116] According to another method of treatment, the valved conduit prosthesis 100 can be a replacement for the native pulmonary valve or a previously implanted pulmonary valved conduit prosthesis where partial or complete reconstruction of the right ventricular outflow tract and / or main pulmonary artery is desired. In certain instances, implantation of the valved conduit prosthesis includes identifying the inflow and outflow portions of the conduit, accessing the intended location with respect to the coronary arteries to ensure that there is no risk of compression of the coronary arteries during the implantation procedure, and optionally trimming the inflow and / or outflow conduits to a length suitable for the implantation procedure while applying appropriate tension.

[0117] According to another method of treating aortic valve disease by replacing the aortic root of a patient, the method includes the steps of providing a valved conduit prosthesis 100 in accordance with an embodiment herein and surgically implanting the valved conduit prosthesis 100 as shown in FIG. 7. The method may further include identifying the inflow and outflow portions 212 and 214 of the conduit 102, accessing the intended location with respect to the anatomy, optionally trimming the inflow and outflow portions 212 and 214 of the conduit to a length suitable for the implant procedure, optionally tapering the inflow end 213 outwardly or optionally everting and rolling the inflow portion 212 towards the leaflet structure 104 to define a sewing cuff 130, cutting the ascending aorta, coupling the inflow portion 212 of the valved conduit prosthesis 100 to the left ventricle adjacent to or replacing the resected aortic valve, and coupling the outflow portion 214 of the valved conduit prosthesis 100 to the severed ascending aorta. The method may further include coupling the coronary artery 128 to the outflow portion 214 of the conduit 102 and establishing a flow path from the conduit lumen 122 to the coronary artery 128. The method may further include coupling a coronary artery 128 to a curve 126 defined by an outflow segment.

[0118] leaflet material The expanded fluoropolymer membrane can include any suitable microstructure, such as pores, to achieve the desired leaflet performance. Other biocompatible polymers that may be suitable for use in the leaflets include, but are not limited to, the following groups: urethanes, silicones (organopolysiloxanes), silicone-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of each of the above.

[0119] In various examples, any of the leaflets 106 (e.g., leaflet constructs) described herein can be formed from biocompatible synthetic materials (e.g., including ePTFE and ePTFE composites, or other materials as desired). Other biocompatible polymers that may be suitable for use in synthetic leaflets include, but are not limited to, urethanes, silicones (organopolysiloxanes), silicone-urethane copolymers, 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.

[0120] In other instances, such leaflet constructs are formed from natural materials such as recycled tissues, including bovine tissue, porcine tissue, and the like.

[0121] The term "elastomer" refers to a polymer or mixture of polymers that has the ability to be stretched to at least 1.3 times its original length and then rapidly retract to nearly its original length when released.

[0122] The term "elastomeric material" refers to a polymer or mixture of polymers that exhibits similar stretch and recovery properties to elastomers, although not necessarily to the same extent.

[0123] The term "non-elastomeric material" refers to a polymer or mixture of polymers that exhibits stretch and recovery properties that are not similar to either an elastomer or an elastomeric material, i.e., are not considered to be elastomers or elastomeric materials as they are commonly known.

[0124] According to embodiments herein, the leaflet 106 comprises a composite material having at least one porous synthetic polymer membrane layer having a plurality of pores and / or spaces therein and an elastomer and / or elastomeric material and / or non-elastomeric material filling the pores and / or spaces of the at least one synthetic polymer membrane layer. According to other examples, the leaflet 106 further comprises a layer of an elastomer and / or elastomeric material and / or non-elastomeric material on the composite material. According to examples, the composite material comprises in the range of 10%-90% porous synthetic polymer membrane by weight.

[0125] Examples of porous synthetic polymeric membranes include expanded (expanded, stretched, or foamed) fluoropolymer membranes having a node and fibril structure that defines pores and / or spaces. In some examples, the expanded fluoropolymer membrane is an expanded polytetrafluoroethylene (ePTFE) membrane. Another example of a porous synthetic polymeric membrane includes a microporous polyethylene membrane.

[0126] Examples of elastomers and / or elastomeric materials and / or non-elastomeric materials include, but are not limited to, copolymers of tetrafluoroethylene and perfluoromethylvinylether (TFE / PMVE copolymers), (per)fluoroalkylvinylethers (PAVEs), urethanes, silicones (organopolysiloxanes), silicone-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures of each of the above. In some examples, the TFE / PMVE copolymers are elastomers that contain 60-20 weight percent tetrafluoroethylene and 40-80 weight percent perfluoromethylvinylether, respectively. In some examples, the TFE / PMVE copolymers are elastomeric materials that contain 67-61 weight percent tetrafluoroethylene and 33-39 weight percent perfluoromethylvinylether, respectively. In some examples, the TFE / PMVE copolymer is a non-elastomeric material that contains 73-68 weight percent tetrafluoroethylene and 27-32 weight percent perfluoromethylvinylether, respectively. The TFE and PMVE components of the TFE-PMVE copolymer are expressed in wt%. For reference, the wt% of PMVE of 40, 33-39, and 27-32 correspond to the mole% of 29, 23-28, and 18-22, respectively.

[0127] In some instances, the TFE-PMVE copolymers exhibit elastomeric, elastomeric and / or non-elastomeric properties.

[0128] In some examples, the composite further comprises a layer or coating of a TFE-PMVE copolymer comprising 73 to 68 weight percent tetrafluoroethylene and 27 to 32 weight percent perfluoromethylvinylether, respectively.

[0129] In some examples, the leaflets 106 are expanded polytetrafluoroethylene (ePTFE) membranes imbibed with a TFE-PMVE copolymer comprising 60-20 weight percent tetrafluoroethylene and 40-80 weight percent perfluoromethylvinylether, respectively, and the leaflets 106 further comprise a coating of a TFE-PMVE copolymer comprising 73-68 weight percent tetrafluoroethylene and 27-32 weight percent perfluoromethylvinylether, respectively, on the blood-contacting surface.

[0130] As discussed above, elastomers and / or elastomeric materials and / or non-elastomeric materials can be combined with the expanded fluoropolymer membrane such that the elastomers and / or elastomeric materials and / or non-elastomeric materials occupy substantially all of the voids or pores within the expanded fluoropolymer membrane.

[0131] Although some examples of suitable leaflet materials have been provided, the above examples are not intended to be read in a limiting sense, and additional or alternative materials are contemplated.

[0132] The inventive features of the present disclosure have been described above both generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of the present disclosure. Thus, the embodiments are intended to cover the modifications and variations of the present disclosure provided they come within the scope of the appended claims and their equivalents. (Aspect) (Aspect 1) a conduit having an exterior surface and an interior surface defining a conduit lumen and a slot therethrough; at least one valve leaflet having an exterior portion coupled to an exterior surface of the conduit and an interior portion disposed within an interior surface of the conduit such that the valve leaflet defines a valve structure such that the valve leaflet is operable as a one-way valve; 13. A valved conduit prosthesis comprising: (Aspect 2) 2. The valved conduit prosthesis of embodiment 1, wherein an exterior portion of the at least one leaflet is bonded to an exterior surface of the conduit by adhesive, thermal bonding, or chemical bonding. (Aspect 3) 2. The valved vascular prosthesis of embodiment 1. (Aspect 4) 4. The valved conduit prosthesis of embodiment 3, wherein the adhesive film is disposed about the conduit. (Aspect 5) 5. The valved conduit prosthesis of embodiment 4, further comprising a flexible film disposed about the conduit and the adhesive film. (Aspect 6) 6. The valved vascular prosthesis of any one of claims 1-5, wherein said flexible film comprises expanded polytetrafluoroethylene (ePTFE) and said adhesive film comprises fluorinated ethylene propylene (FEP). (Aspect 7) 7. The valved conduit prosthesis of any one of the preceding embodiments, further comprising a support frame coupled to said conduit by said flexible film. (Aspect 8) 8. The valved conduit prosthesis of embodiment 7, wherein the support frame is formed from polyetheretherketone (PEEK). (Aspect 9) 9. The valved conduit prosthesis of any one of the preceding embodiments, further comprising at least one radiopaque marker disposed adjacent to the at least one leaflet on an exterior surface of the conduit. (Aspect 10) 10. The valved conduit prosthesis of any one of embodiments 1-9, wherein the inner surface of the conduit is diametrically constant and free of macroscopic interruptions. (Aspect 11) 11. The valved conduit prosthesis of any one of claims 1 to 10, wherein the at least one leaflet is disposed within the conduit at a longitudinal position along a length of the conduit, the conduit being diametrically constant through adjacent proximal and distal portions of the conduit at the longitudinal position at which the at least one leaflet is disposed. (Aspect 12) 12. The valved conduit prosthesis of any one of embodiments 1-11, wherein the conduit has an inflow portion defining an inflow end and an outflow portion defining an outflow end, and wherein the at least one leaflet is operable to open to allow flow from the inflow end of the conduit through the outflow end under antegrade flow conditions and to close to restrict flow from the outflow end through the inflow end under retrograde flow conditions. (Aspect 13) The at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores; and Optionally, on at least a portion of said composite material, a TFE-PMVE copolymer comprising 27 to 32 weight percent perfluoromethylvinylether and 73 to 68 weight percent tetrafluoroethylene, respectively; Including, and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer; 13. The valved conduit prosthesis of any one of aspects 1 to 12, and optionally, said porous synthetic fluoropolymer membrane is ePTFE. (Aspect 14) 14. The valved conduit prosthesis of any one of aspects 12 and 13, wherein the outflow portion defines a curve adjacent the at least one leaflet. (Aspect 15) 15. The valved conduit prosthesis of embodiment 14, wherein the curved portion is operable for surgical attachment of a blood vessel and / or a coronary artery. (Aspect 16) 16. The valved conduit prosthesis of any one of the preceding embodiments, wherein the inflow end defines an outward taper or is operable to be outwardly tapered. (Aspect 17) 16. The valved conduit prosthesis of any one of embodiments 1-15, wherein the inflow portion is operable to be everted outward and rolled toward the valve structure to define a sewing cuff. (Aspect 18) a conduit having an inner surface, an outer surface, a proximal portion, and a distal portion defining a conduit lumen; a leaflet attachment portion having an opening between an inner surface and an outer surface of the conduit; and at least one leaflet having an attachment section coupled to an exterior surface of the conduit, the at least one leaflet defining a valve structure; 13. A valved conduit prosthesis comprising: (Aspect 19) 20. The valved conduit prosthesis of embodiment 18, wherein the at least one leaflet comprises three leaflets, the three leaflets being separated from one another within the conduit by a commissure gap. (Aspect 20) 20. The valved conduit prosthesis of claim 19, wherein the conduit includes lands separating the leaflets at the attachment sections of each of the leaflets to form the commissure gaps between the three leaflets within an inner surface of the conduit. (Aspect 21) 20. The valved conduit prosthesis of embodiment 19, wherein the attachment section is attached to the outer surface of the conduit by adhesive, thermal bonding, or chemical bonding. (Aspect 22) 20. The valved conduit prosthesis of embodiment 19, wherein the attachment section includes a first portion and a second portion, the first portion being attached to a proximal portion of the outer surface of the conduit and the second portion being attached to a distal portion of the outer surface of the conduit. (Aspect 23) 20. The valved conduit prosthesis of embodiment 19, wherein the leaflet attachment portion is a portion of a conduit, and wherein the leaflet attachment portion is denser than a remainder of the conduit. (Aspect 24) 24. The valved conduit prosthesis of any one of aspects 18-23, further comprising a directional indicator on an exterior surface of the conduit to indicate a direction of blood flow within the conduit. (Aspect 25) 25. The valved conduit prosthesis of any one of aspects 18-24, wherein the conduit has an inflow portion defining an inflow end and an outflow portion defining an outflow end, and wherein the at least one leaflet is coupled to the conduit and operable to open to allow flow from the inflow end through the outflow end of the conduit in an antegrade flow condition and operable to close to restrict flow from the outflow end through the conduit inflow end in a retrograde flow condition. (Aspect 26) The at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores; and Optionally, on at least a portion of said composite material, a TFE-PMVE copolymer comprising 27 to 32 weight percent perfluoromethylvinylether and 73 to 68 weight percent tetrafluoroethylene, respectively; and optionally, the elastomer or elastomeric material comprises a TFE-PMVE copolymer; 22. The valved vascular prosthesis of any one of aspects 18 to 21, and optionally, said porous synthetic fluoropolymer membrane is ePTFE. (Aspect 27) 27. The valved conduit prosthesis of any one of embodiments 18-26, wherein the outflow portion defines a curve adjacent the at least one leaflet. (Aspect 28) 28. The valved conduit prosthesis of embodiment 27, wherein the curved portion is operable for surgical attachment of a blood vessel and / or a coronary artery. (Aspect 29) 29. The valved conduit prosthesis of any one of embodiments 18-28, wherein the inflow end defines an outward taper or is operable to be outwardly tapered. (Aspect 30) 29. The valved conduit prosthesis of any one of embodiments 18-28, wherein the inflow portion is operable to be everted outward and wrapped toward the valve structure to define a sewing cuff. (Aspect 31) 23. A method of treating aortic valve disease by replacing the aortic root, comprising providing a valved conduit prosthesis according to any one of claims 1 to 22 and surgically implanting the valved conduit prosthesis. (Aspect 32) identifying an inlet portion and an outlet portion of the conduit; accessing the intended location with respect to the anatomical structure; Optionally, trimming the inflow and outflow portions of the conduit to a length suitable for implantation procedures; Optionally, outwardly tapering the inflow end or optionally everting and rolling the inflow portion towards the leaflet structure to define a sewing cuff; Cutting the ascending aorta, coupling an inflow portion of the valved conduit prosthesis to the left ventricle adjacent to or as a replacement for the excised aortic valve; and connecting the outflow portion of the valved conduit prosthesis to the severed ascending aorta; 32. The method of embodiment 31, further comprising: (Aspect 33) connecting a coronary artery to an outflow portion of said conduit; and establishing a flow path from the conduit lumen to a coronary artery; 33. The method of embodiment 32, further comprising: (Aspect 34) The method of embodiment 33, wherein coupling the coronary artery comprises coupling the coronary artery to a curve defined by the outflow segment.

Claims

1. a conduit having an exterior surface and an interior surface defining a conduit lumen and a slot therethrough; at least one valve leaflet having an exterior portion coupled to an exterior surface of the conduit and an interior portion disposed within an interior surface of the conduit such that the valve leaflet defines a valve structure such that the valve leaflet is operable as a one-way valve; Including, A valved conduit prosthesis, comprising: an outflow section defining an outflow end of the conduit; a curved portion at which a blood vessel and / or a coronary artery is attached, establishing a flow path from a lumen of the conduit to the blood vessel and / or the coronary artery.

2. 10. The valved conduit prosthesis of claim 1, wherein an exterior portion of the at least one leaflet is bonded to an exterior surface of the conduit by an adhesive, a layer of adhesive film, thermal bonding, or chemical bonding.

3. 3. The valved conduit prosthesis of claim 2, wherein the adhesive, layer of adhesive film, thermal bond or chemical bond is disposed about the conduit.

4. 4. The valved conduit prosthesis of claim 3, further comprising a flexible film disposed about said conduit and said layer of adhesive, adhesive film, thermal bond or chemical bond.

5. 5. The valved conduit prosthesis of claim 4, wherein said flexible film comprises expanded polytetrafluoroethylene (ePTFE) and said adhesive film comprises fluorinated ethylene propylene (FEP).

6. The valved conduit prosthesis of any one of claims 4 to 5, further comprising a support frame coupled to said conduit by said flexible film.

7. The valved conduit prosthesis of claim 6, wherein the support frame is formed from polyetheretherketone (PEEK).

8. The valved conduit prosthesis of any one of claims 1 to 7, further comprising at least one radiopaque marker disposed adjacent to said at least one leaflet on an exterior surface of said conduit.

9. 9. The valved conduit prosthesis of any one of claims 1 to 8, wherein the at least one leaflet is disposed within the conduit at a longitudinal position along a length of the conduit, and the conduit is diametrically constant through adjacent proximal and distal portions of the conduit at the longitudinal position at which the at least one leaflet is disposed.

10. 10. The valved conduit prosthesis of any one of claims 1 to 9, wherein the conduit has an inflow portion defining an inflow end, and wherein the at least one leaflet is operable to open to allow flow from the inflow end of the conduit through the outflow end under antegrade flow conditions, and to close to restrict flow from the outflow end through the inflow end under retrograde flow conditions.

11. 11. The valved conduit prosthesis of claim 10, wherein the at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores.

12. 12. The valved conduit prosthesis of claim 11, comprising a TFE-PMVE copolymer comprising 27 to 32 weight percent perfluoromethylvinylether and 73 to 68 weight percent tetrafluoroethylene, based on the TFE-PMVE copolymer, disposed on at least a portion of the composite material.

13. The valved conduit prosthesis of claim 11 or 12, wherein the elastomer or elastomeric material comprises a TFE-PMVE copolymer.

14. The valved vascular prosthesis of any one of claims 11 to 13, wherein the porous synthetic fluoropolymer membrane is ePTFE.

15. The valved conduit prosthesis of any one of claims 10 to 14, wherein the inflow end defines an outward taper.

16. The valved conduit prosthesis of any one of claims 10 to 14, wherein the inflow portion is everted outwardly and rolled towards the valve structure to define a sewing cuff.

17. a conduit having an inner surface, an outer surface, a proximal portion, and a distal portion defining a conduit lumen; a leaflet attachment portion having an opening between an inner surface and an outer surface of the conduit; and at least one leaflet having an attachment section coupled to an outer surface of the conduit, the at least one leaflet defining a valve structure; Including, A valved conduit prosthesis, comprising: an outflow section defining an outflow end of the conduit; a curved portion at which a blood vessel and / or a coronary artery is attached, establishing a flow path from a lumen of the conduit to the blood vessel and / or the coronary artery.

18. 20. The valved conduit prosthesis of claim 17, wherein the at least one leaflet comprises three leaflets, the three leaflets being separated from one another within the conduit by commissure gaps.

19. 20. The valved conduit prosthesis of claim 18, wherein the conduit includes lands separating the leaflets at the attachment section of each of the leaflets to form the commissure gaps between the three leaflets within an interior surface of the conduit.

20. 20. The valved conduit prosthesis of claim 18, wherein the attachment section is attached to the outer surface of the conduit by adhesive, thermal bonding or chemical bonding.

21. 20. The valved conduit prosthesis of claim 18, wherein the attachment section includes a first portion and a second portion, the first portion being attached to a proximal portion of the outer surface of the conduit and the second portion being attached to a distal portion of the outer surface of the conduit.

22. 20. The valved conduit prosthesis of claim 18, wherein the leaflet attachment portion is a portion of a conduit, the leaflet attachment portion being denser than the remainder of the conduit.

23. The valved conduit prosthesis of any one of claims 17 to 22, further comprising a directional indicator on an outer surface of the conduit to indicate a direction of blood flow within the conduit.

24. 24. The valved conduit prosthesis of any one of claims 17 to 23, wherein the conduit has an inflow portion defining an inflow end, and wherein the at least one leaflet is coupled to the conduit and operable to open to allow flow from the inflow end through the outflow end of the conduit in an antegrade flow condition, and operable to close to restrict flow from the outflow end through the inflow end of the conduit in a retrograde flow condition.

25. 25. The valved conduit prosthesis of claim 24, wherein the at least one leaflet comprises a composite material including a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastomeric material filling the pores.

26. 26. The valved conduit prosthesis of claim 25, comprising a TFE-PMVE copolymer comprising 27 to 32 weight percent perfluoromethylvinylether and 73 to 68 weight percent tetrafluoroethylene, based on the TFE-PMVE copolymer, disposed on at least a portion of the composite material.

27. The valved conduit prosthesis of claim 25 or 26, wherein the elastomer or elastomeric material comprises a TFE-PMVE copolymer.

28. The valved vascular prosthesis of any one of claims 25 to 27, wherein the porous synthetic fluoropolymer membrane is ePTFE.

29. The valved conduit prosthesis of any one of claims 24 to 28, wherein the inflow end defines an outward taper.

30. The valved conduit prosthesis of any one of claims 24 to 28, wherein the inflow portion is everted outwardly and rolled towards the valve structure to define a sewing cuff.

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