Valved conduit in a pipeline prosthesis

Abstract

Various aspects of the present disclosure relate to apparatuses, systems, and methods including a valved conduit prosthesis including a valved conduit subassembly within a secondary conduit. The valved conduit subassembly includes at least one leaflet coupled to an outer surface of a primary conduit.

Description

Technical Field

[0001] This disclosure generally relates to prosthetic valves, and more specifically, to devices, systems, and methods comprising conduits having valve structures therein. Background Technology

[0002] Biological prosthetic heart valves have been developed that attempt to mimic the function and performance of natural valves. Flexible leaflets can be attached to a relatively rigid frame or other support structure that supports the leaflets and provides dimensional stability upon implantation. The leaflets require some means for securing them to the support 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 edges of the leaflets are tightened under the influence of the downstream fluid pressure closing the prosthetic heart valve to prevent retrograde blood flow through the prosthetic heart valve.

[0003] The durability of prosthetic heart valves under repetitive loading of leaflet opening and closing depends in part on the load distribution between the leaflet and the frame or support structure, particularly the attachment of the leaflet to the frame. For example, mechanical failure of the leaflet may occur at the mounting edge where a flexible leaflet is supported by a relatively rigid frame. Material failure due to fatigue, creep, or other mechanisms under repetitive loading of leaflet opening and closing depends in part on the leaflet material. Summary of the Invention

[0004] The described embodiments relate to devices, systems, and methods for valved tubular prostheses.

[0005] According to one example (“Example 1”), the valved tube prosthesis includes a tube having an inner surface and an outer surface; and at least one leaflet having an outer portion non-mechanically adhered to the outer surface of the tube and an inner portion disposed within the inner surface of the tube.

[0006] According to a further example of Example 1 (“Example 2”), at least one outer portion of a leaflet is adhered to the outer surface of the pipe by adhesive, thermal bonding or chemical bonding.

[0007] According to any further example of Examples 1 to 2 (“Example 3”), the conduit does not contain a sinus.

[0008] According to any further example of Examples 1 to 2 (“Example 4”), the pipe does not contain mechanical connections.

[0009] According to any one of Examples 1 to 4, in a further example (“Example 5”), at least one outer portion of a leaflet is attached to the outer surface of the conduit, and the attachment is seamless.

[0010] According to any one of Examples 1 to 5, in a further example (“Example 6”), at least one outer portion of a leaflet is adhered to the outer surface of the pipe by a layer of adhesive film.

[0011] According to another further example of Example 6 (“Example 7”), the adhesive membrane is arranged around the circumference of the pipe.

[0012] According to any one of Examples 6 to 7, in another further example (“Example 8”), it further includes a flexible membrane and an adhesive membrane arranged circumferentially around the pipe.

[0013] According to a further example of Example 8 (“Example 9”), the flexible membrane comprises expanded polytetrafluoroethylene (ePTFE) and the adhesive membrane comprises fluorinated ethylene propylene (FEP).

[0014] According to any one of Examples 8 to 9, in another further example (“Example 10”), it further includes a support frame connected to the pipe via a flexible membrane.

[0015] According to another further example of Example 10 (“Example 11”), the support frame is formed of polyetheretherketone (PEEK).

[0016] According to any one of Examples 1 to 11, in a further example (“Example 12”), it further includes at least one non-transmissive mark on the outer surface of the pipe adjacent to at least one leaflet arrangement.

[0017] According to any one of Examples 1 to 12, in another further example (“Example 13”), the inner surface of the pipe is constant in diameter and has no macroscopic interruptions.

[0018] According to any one of Examples 1 to 13, in a further example (“Example 14”), at least one leaflet is located within the pipe at a longitudinal position along the length of the pipe, and the pipe is constant in diameter at the longitudinal position where at least one leaflet is located and through the adjacent proximal and distal portions of the pipe.

[0019] 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 a conduit attachment segment attached to the outer surface of the conduit without mechanically altering the inner or outer surfaces of the conduit to mitigate thrombosis within the conduit.

[0020] According to a further example of Example 15 (“Example 16”), at least one leaflet comprises three leaflets, and the three leaflets are separated from each other by a platform inside the pipe.

[0021] According to a further example of Example 16 (“Example 17”), the conduit includes a platform at the conduit attachment section of each leaflet that separates the leaflets to form a connecting gap between the three leaflets within the inner surface of the conduit. In another example, the connecting gap provides a backflow path when the valve is in the closed position.

[0022] According to any one of Examples 15 to 17, in another further example (“Example 18”), the pipe attachment section of the leaflet is attached to the outer surface of the pipe by adhesive, thermal bonding or chemical bonding.

[0023] According to any one of Examples 15 to 18, in another further example (“Example 19”), the attachment section includes a first portion and a second portion, wherein the first portion is attached to a proximal portion of the outer surface of the pipe and the second portion is attached to a distal portion of the outer surface of the pipe.

[0024] According to any one of Examples 15 to 19, in another further example (“Example 20”), the leaflet attachment portion is part of the conduit, and the leaflet attachment portion is denser than the rest of the conduit.

[0025] According to any one of Examples 15 to 20, a further example (“Example 21”) includes a valved conduit prosthesis that also includes a direction indicator on the outer surface of the conduit to indicate the direction of blood flow within the conduit when it is in the open position.

[0026] According to one example (“Example 22”), a method for reducing thrombosis resulting from replacement of a natural pulmonary valve or a previously implanted pulmonary valved conduit prosthesis, wherein partial or complete reconstruction of the right ventricular outflow tract and / or the main pulmonary artery is desired, the method comprising the steps of: providing a valved conduit prosthesis comprising a synthetic conduit having a distal, proximal, internal, external, and leaflet attachment portions; and at least one flexible synthetic leaflet having an external portion and an internal portion of the conduit, wherein the external leaflet portion, as the conduit attachment portion of the leaflet, is attached to the external conduit at the attachment portion; and surgically implanting the valved conduit prosthesis.

[0027] According to one example (“Example 23”), a method for replacing a natural pulmonary valve or a previously implanted pulmonary valved conduit prosthesis, wherein partial or complete reconstruction of the right ventricular outflow tract and / or the main pulmonary artery is desired, the method comprising the steps of: providing a valved conduit prosthesis that has been flushed in saline and has not yet coagulated, the valved conduit prosthesis comprising a synthetic conduit and at least one flexible synthetic leaflet attached to the synthetic conduit; and surgically implanting the valved conduit prosthesis.

[0028] According to one example (“Example 24”), a method for replacing a natural pulmonary valve or a previously implanted pulmonary valved conduit prosthesis, wherein partial or complete reconstruction of the right ventricular outflow tract and / or the main pulmonary artery is desired, the method comprising the steps of: providing a valved conduit prosthesis that has been flushed in saline and has not yet coagulated, wherein the valved conduit prosthesis comprises a non-biological conduit and at least one flexible polymer non-biological valve leaflet attached to the non-biological conduit; identifying the inflow and outflow portions of the valved conduit prosthesis; positioning it relative to the intended location of the coronary artery to ensure no risk of coronary artery compression at implantation; optionally trimming the inflow and / or outflow conduit to the appropriate implantation length under moderate tension; and attaching the valved conduit prosthesis.

[0029] According to one example (“Example 25”), an encapsulation insert for a valved conduit prosthesis includes a support structure configured to fold to form one or more supports and is inserted into the valved conduit prosthesis to support one or more valves within the valved conduit prosthesis.

[0030] According to an example (“Example 26”), a method for treating aortic valve disease by replacing the aortic root includes the steps of: providing a valved conduit prosthesis as described in any of the above examples; and surgically implanting the valved conduit prosthesis.

[0031] According to Example 27, the method according to Example 26 further includes identifying the inflow and outflow portions of the conduit; entering the intended location relative to the anatomical structure; optionally trimming the inflow and outflow portions of the conduit to an appropriate implantation length; optionally tapering the inflow end outward or optionally flipping and rolling up the inflow portion toward the leaflet structure defining the suture closure; incising the ascending aorta; connecting the inflow portion of the valved conduit prosthesis to the left ventricle adjacent to or replacing the resected aortic valve; and connecting the outflow portion of the valved conduit prosthesis to the incised ascending aorta.

[0032] According to Example 28, the method described in Example 27 further includes connecting a coronary artery to the outflow portion of conduit 102 and establishing a flow path from the conduit lumen to the coronary artery.

[0033] According to Example 29, the method described in Example 28 further includes connecting a coronary artery to a sinus defined by an outflow portion.

[0034] According to any one of Examples 1 to 29 (“Example 30”), one or more leaflets comprise a composite material comprising a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastic material filling the pores, and optionally a TFE-PMVE copolymer comprising 27 to 32 wt% perfluoromethyl vinyl ether and correspondingly 73 to 68 wt% tetrafluoroethylene in at least a portion of the composite material, and optionally, the elastomer or elastic material comprises the TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.

[0035] According to any one of Examples 1 to 30 (“Example 31”), the pipe has an inflow portion defining an inflow end and an outflow portion defining an outflow end, wherein at least one leaflet is operable to open under forward flow conditions to allow flow from the inflow end through the outflow end of the pipe, and operable to close under reverse flow conditions to restrict flow from the outflow end through the inflow end.

[0036] According to any one of Examples 1 to 31 (“Example 32”), at least one leaflet comprises a composite material comprising a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastic material filling the pores, and optionally a TFE-PMVE copolymer comprising 27 to 32 wt% perfluoromethyl vinyl ether and correspondingly 73 to 68 wt% tetrafluoroethylene in at least a portion of the composite material, and optionally, the elastomer or elastic material comprises the TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.

[0037] A further example of any of Examples 1 to 32 (“Example 33”), wherein the outflow portion defines a sinus adjacent to at least one leaflet.

[0038] According to a further example of Example 33 (“Example 34”), the sinus is operable for surgical attachment of blood vessels and / or coronary arteries.

[0039] According to any of Examples 1 to 34, a further example (“Example 35”) is provided, wherein the inflow end is defined as an outward tapering section or operable to tape outward.

[0040] According to any of Examples 1 to 34, in a further example (“Example 36”), the inflow portion is operable to flip outward and roll up toward the valve structure defining the suture closure.

[0041] According to an 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 segment attached to the outer surface of the conduit, the at least one leaflet defining a valve structure.

[0042] According to a further example of Example 37 (“Example 38”), at least one leaflet comprises three leaflets, and the three leaflets are separated from each other inside the conduit by a connecting gap.

[0043] According to a further example of Example 38 (“Example 39”), the conduit includes a platform at the attachment section of each leaflet to separate the leaflets, so as to form a connecting gap between the three leaflets within the inner surface of the conduit.

[0044] According to any of the further examples of Examples 37 to 39 (“Example 40”), the attachment section is attached to the outer surface of the pipe by adhesive, thermal bonding or chemical bonding.

[0045] According to any of the further examples in Examples 37 to 40 (“Example 41”), the leaflet attachment portion is part of the conduit, and the leaflet attachment portion is denser than the rest of the conduit.

[0046] According to any one of Examples 37 to 41 (“Example 42”), the pipe has an inflow portion defining an inflow end and an outflow portion defining an outflow end, wherein at least one leaflet connected to the pipe is operable to open under forward flow conditions to allow flow from the inflow end through the outflow end of the pipe, and operable to close under reverse flow conditions to restrict flow from the outflow end through the inflow end of the pipe.

[0047] According to any one of Examples 37 to 42 (“Example 43”), at least one leaflet comprises a composite material comprising a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastic material filling the pores, and optionally a TFE-PMVE copolymer comprising 27 to 32 wt% perfluoromethyl vinyl ether and correspondingly 73 to 68 wt% tetrafluoroethylene in at least a portion of the composite material, and optionally, the elastomer or elastic material comprises the TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.

[0048] According to an example (“Example 44”), a valved conduit prosthesis includes: a secondary conduit having an inner surface defining a secondary conduit lumen therethrough; and a valved conduit subassembly comprising: a primary conduit having an outer surface defining a primary conduit lumen and an inner surface defining a primary conduit lumen, and a slot therethrough; and at least one leaflet having an outer portion connected to the outer surface of the primary conduit and an inner portion disposed within the primary conduit lumen to be operable as a unidirectional valve, the leaflet defining a valve structure, wherein the valved conduit subassembly is located within the secondary conduit lumen and connected to the inner surface of the secondary conduit.

[0049] According to Example (“Example 45”), the valved conduit prosthesis according to Example 44, wherein the outer portion of at least one valve leaflet is adhered to the outer surface of the primary conduit by adhesive, thermal bonding or chemical bonding.

[0050] According to a further example of Example 44 (“Example 46”), the outer portion of at least one leaflet is attached to the outer surface of the primary conduit by a layer of adhesive film.

[0051] According to any one of Examples 44 to 46 (“Example 47”), the flapped pipe subassembly and the inner surface of the secondary pipe define at least one step.

[0052] According to a further example of Example 47 (“Example 48”), at least one step is defined by a secondary conduit having an inner diameter that is larger than the inner diameter of the flap conduit subassembly.

[0053] According to any further example of Examples 47 to 48 (“Example 49”), the step may have a step height defined at the step by the inner surfaces of the primary conduit and the secondary conduit, wherein the step height is operable as a barrier to prevent pannus or other biological material from advancing into the upstream or downstream portion of the valved conduit subassembly.

[0054] According to any one of Examples 47 to 49 (“Example 50”), the valved pipe subassembly defines an upstream length between the valve leaflet and the step, wherein the upstream length has a dimension of 0.1 mm to 3 mm, and the step height has a dimension of 0 mm to 3 mm.

[0055] According to any one of Examples 44 to 50 (“Example 51”), the valved conduit has an inflow portion defining an inflow end and an outflow portion defining an outflow end, wherein at least one valve connected to the primary conduit is operable to open under forward flow conditions to allow flow from the inflow end through the outflow end, and operable to close under reverse flow conditions to restrict flow from the outflow end through the inflow end.

[0056] According to any one of Examples 44 to 51 (“Example 52”), at least one leaflet comprises a composite material comprising a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastic material filling the pores, and optionally a TFE-PMVE copolymer comprising 27 to 32 wt% perfluoromethyl vinyl ether and correspondingly 73 to 68 wt% tetrafluoroethylene in at least a portion of the composite material, and optionally, the elastomer or elastic material comprises the TFE-PMVE copolymer, and optionally, the porous synthetic fluoropolymer membrane is ePTFE.

[0057] According to any further example of Examples 44 to 52 (“Example 53”), at least one leaflet comprises more than one leaflet, and the more than one leaflet is separated from each other by a connecting gap within the inner surface of the primary conduit.

[0058] According to a further example of Example 53 (“Example 54”), the primary conduit includes a platform at the conduit attachment section of each leaflet that will separate more than one leaflet to form a connecting gap between the three leaflets within the inner surface of the primary conduit.

[0059] According to any one of Examples 44 to 54 (“Example 55”), the valved pipe subassembly is attached to the inner surface of the secondary pipe by adhesive, thermal bonding or chemical bonding.

[0060] According to an example (“Example 56”), one method for treating aortic valve disease by replacing the aortic root includes the steps of: providing a valved conduit prosthesis as described in any one of Examples 44 to 55; and surgically implanting the valved conduit prosthesis.

[0061] The foregoing examples are merely examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concepts otherwise provided by this disclosure. Attached Figure Description

[0062] Any accompanying drawings are included to provide a further understanding of this disclosure, and these drawings are incorporated in and form a part of this specification, illustrating several embodiments of this disclosure, and together with the description serve to explain the principles of this disclosure.

[0063] Figure 1A This is a side view of an exemplary valved tube prosthesis according to an embodiment;

[0064] Figure 1B It is based on Figure 1A An axial view of the valve structure in a closed configuration according to an embodiment;

[0065] Figure 1C It is based on Figure 1AThe embodiment is in an axial view of the valve structure in an open configuration;

[0066] Figure 2 This is a side view of another valved tube prosthesis according to another embodiment;

[0067] Figure 3 This is a cross-sectional view of another valved tube prosthesis according to an embodiment;

[0068] Figure 4A This is a side view of a pipe according to an embodiment, including a cut pattern of a pipe for use in a valved pipe prosthesis.

[0069] Figure 4B This is a side view of a pipe including a cut pattern for use in a valved pipe prosthesis, according to another embodiment.

[0070] Figure 4C This is a side view of a pipe including a cut pattern for use in a valved pipe prosthesis, according to another embodiment.

[0071] Figure 5 This is a top view of a valve leaflet that can be used in a valved tube prosthesis according to an embodiment;

[0072] Figure 6A This is an illustration of an exemplary step for attaching a leaflet to a pipe according to an embodiment;

[0073] Figure 6B It is based on Figure 6A An illustration of another exemplary step for attaching a leaflet to a pipe, according to an embodiment;

[0074] Figure 6C It is based on Figures 6A to 6B An illustration of another exemplary step for attaching a leaflet to a pipe, according to an embodiment;

[0075] Figure 7 This is a cross-sectional view of a valved tube prosthesis according to another embodiment;

[0076] Figure 8 This is a cross-sectional view of a valved tube prosthesis according to another embodiment;

[0077] Figure 9 This is a side view of a valved catheter in a tubular prosthesis according to an embodiment;

[0078] Figure 10 yes Figure 9 A side cross-sectional view of the valve region in an embodiment; and

[0079] Figure 11 This is a side cross-sectional view of the valve region in another embodiment. Detailed Implementation

[0080] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale but may be enlarged to illustrate various aspects of this disclosure, and in this respect, the drawings should not be construed as limiting.

[0081] While the embodiments described herein may be incorporated into various principles and beliefs, the described embodiments should not be limited by theory. For example, embodiments are described herein in conjunction with prosthetic valved conduits. However, embodiments within the scope of this disclosure can be applied to any valved conduit prosthesis, valve structure, or similar structure and / or function. Furthermore, embodiments within the scope of this disclosure can be applied to non-cardiac applications.

[0082] The embodiments described herein include various devices, systems, and methods for a conduit having a valve structure operable as a prosthetic valve. The valve structure may include one or more leaflets operable as a one-way valve, wherein the conduit defines a conduit lumen. The leaflets open to allow flow and close to seal the conduit lumen and prevent flow in response to a differential fluid pressure.

[0083] As used herein, the term "pipe" is defined as a tubular member having a lumen operable to guide fluid through and having walls impermeable to fluid transfer.

[0084] As used herein, the terms “valved conduit” and “valved conduit prosthesis” are used interchangeably and are defined as conduits having a valve structure attached to and contained within the conduit for use in coronary or vascular surgery.

[0085] As used herein, the term “valve structure” is defined as a leaflet structure having one or more individual leaflets or multiple leaflets joined together to act as one-way valves.

[0086] As used herein, the term "leaflet structure" is defined as a valve structure comprising multiple leaflets connected together with commissural regions between each leaflet.

[0087] As used herein, the term "valved pipe assembly" is defined as a valved pipe of reduced length that can be located within a primary pipe.

[0088] As used herein, the term “film” refers to a sheet comprising a single material, such as, but not limited to, expanded fluoropolymers.

[0089] As used herein, the term "composite material" refers to a combination of membranes, such as, but not limited to, expanded fluoropolymers and elastomers or elastic materials, such as, but not limited to, fluoroelastomers. Elastomers or elastic materials may be contained within the porous structure of the membrane, coated on one or both surfaces of the membrane, or coated on and contained within the porous structure of the membrane.

[0090] As used herein, the term “layered compound” refers to multilayer films, composite materials or other materials, such as elastomers or elastic materials, and combinations thereof.

[0091] As used herein, the term “thin film” generally refers to one or more of a membrane, composite material, or laminate.

[0092] As used herein, the term “biocompatible material” generally refers to any material (including synthetic materials) that has biocompatible characteristics, such as, but not limited to, biocompatible polymers, or biomaterials such as, but not limited to, bovine pericardium.

[0093] As used herein, the term "joint" refers to joining, connecting, attaching, adhering, fixing, or combining, whether directly or indirectly, and whether permanently or temporarily.

[0094] The embodiments described herein encompass various devices, systems, and methods for conduits having a valve structure operable as a prosthetic valve, such as, but not limited to, when replacing a natural pulmonary valve or a previously implanted pulmonary valved conduit prosthesis, where partial or complete reconstruction of the right ventricular outflow tract and / or the main pulmonary artery is desired. The valve structure may include one or more leaflets operable as a one-way valve, wherein the conduit defines a conduit lumen. The leaflets open to allow flow and close to seal the conduit lumen and prevent reverse flow in response to a fluid differential pressure. The conduit is operable to be surgically connected to a corresponding anatomical structure using, for example, but not limited to, sutures.

[0095] The embodiments described herein include various devices, systems, and methods for a conduit having a valve structure operable as a prosthetic valve, which can be used, for example, but not limited to, replacing the aortic valve and a portion of the aorta, such as the ascending aorta. The valve structure may include one or more leaflets operable as a one-way valve, wherein the conduit defines a conduit lumen. The leaflets open to allow flow and close to seal the conduit lumen and prevent reverse flow in response to a differential fluid pressure. The conduit is operable to be surgically connected to the left atrium proximally using, for example, but not limited to, sutures, and to a portion of the ascending aorta distally. In other embodiments, the conduit may also be operable to surgically attach one or more coronary arteries thereto to establish blood flow to the conduit.

[0096] Figure 1AThis is a side view of a valved conduit prosthesis 100 according to an embodiment. The valved conduit prosthesis 100 includes a conduit 102 in which a valve structure 104 is disposed. The conduit 102 includes an inflow end 213 and an outflow end 215, through which a conduit lumen 122 extends, such that the valve structure 104 is operable to allow flow in one direction from the inflow end 213 to the outflow end 215.

[0097] In a non-limiting instance, the valved conduit prosthesis 100 can be used to replace at least a portion of the aortic valve and the ascending aorta. In one non-limiting instance, the valved conduit prosthesis 100 can be indicated for correction or reconstruction of the aortic root and aortic valve in pediatric patients, i.e., aortic root replacement. The valved conduit prosthesis 100 can also be indicated for replacement of a previously implanted allograft or a valved conduit that has become dysfunctional or inadequate.

[0098] In a non-limiting instance, the valved conduit prosthesis 100 can be used as a shunt connecting the right ventricle to the pulmonary artery after a Norwood procedure, as often performed to treat hypoplastic left heart syndrome. In a non-limiting instance, the valved conduit prosthesis 100 can be indicated for the correction or reconstruction of the right ventricular outflow tract (RVOT) in pediatric patients. This reconstruction can be indicated for congenital heart diseases such as tetralogy of Fallot, truncus arteriosus, right rotation of the great arteries, pulmonary atresia with intact ventricular septum, or aortic valve disease. The valved conduit prosthesis 100 can also be indicated for the replacement of previously implanted allografts or valved conduits that have become dysfunctional or inadequate. Additionally, the valved conduit prosthesis 100 can be used to treat a wider range of cardiac conditions, including other areas of the heart.

[0099] Generally, the term "distal" is used in this disclosure to refer to the outflow end 215 (distal) 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. Forward or forward flow is the flow of fluid from the inflow end 213 to the outflow end 215, and reverse flow (also called backflow) is the flow of fluid from the outflow end 215 to the inflow end 213 when leakage occurs through the closed valve structure 104.

[0100] In some embodiments, the conduit 102 discussed herein comprises an expandable fluoropolymer material supported by a porous ePTFE membrane. The expandable fluoropolymer used to form the described expandable fluoropolymer material may include a PTFE homopolymer. In alternative embodiments, blends of PTFE, expandable modified PTFE, and / or expandable copolymers of PTFE may be used. In some embodiments, the porous ePTFE membrane is made non-porous, for example by coating or impregnation with an elastomer or elastomeric material, to prevent fluid from passing through the walls of the conduit 102, making the walls impermeable for fluid transfer.

[0101] In some embodiments, the entire conduit 102 may comprise the same material, such as ePTFE, but with different material properties at predetermined locations. This will be explained below and in... Figure 3 For example, at leaflet 106 and adjacent to conduit 102, the material can be "densified," meaning that the material can become denser or less porous at said location through, but not limited to, thermal, coating, or percolation processes. This location at leaflet 106 and adjacent to conduit 102 is referred to herein as valve region 350. Figure 3 As shown in the diagram. The valve region 350 has different material properties than the rest of the conduit 102 for specific purposes, such as, but not limited to, providing a more rigid structure for supporting the leaflet attachment portion 322 to provide geometric integrity to the slit 434, for handling during manufacturing, and for reinforcing the transverse cut 438 between the first conduit 102a and the second conduit 102b in embodiments having such an element, as... Figure 4C , 6A As shown in 6C.

[0102] Figure 1B and 1C Explain each according to Figure 1A The embodiment is shown in an axial view of the valve structure 104 in an open and closed configuration. The valve structure 104 includes leaflets 106 extending from the inner surface 318 of the conduit 102 into the interior of the conduit 102. The valve structure 104 is defined as one or more individual leaflets 106 or a leaflet configuration having multiple leaflets 106 joined together to act as unidirectional valves. Although in Figure 1B and 1C The diagram shows three leaflets 106, but the valve structure 104 may contain one, two, three, four, or more leaflets 106. Figure 1B As shown, leaflet 106 closes toward the center 108 of conduit 102 in the closed configuration. In the open configuration, as... Figure 1C As shown, blood can flow through valve structure 104, where leaflets 106 are forced toward the inner surface 110 of conduit 102. According to an embodiment, leaflets 106 can be coupled to conduit 102 as valve structure 104, such that the inner surface 110 of conduit 102 has a smooth interior with a uniform inner diameter from inflow end 213 to outflow end 215, the inner diameter being interrupted only by leaflets 106 themselves. As will be described below, leaflets 106 are coupled to conduit 102 via tabs 542 coupled to the outer surface 320 of conduit 102, while leaflets 125 extend from the inner surface 110 of conduit into the lumen 122 of conduit.

[0103] In other embodiments, as provided below, a valved conduit assembly 1000 is provided, meaning that the valved conduit prosthesis 100 is contained within a secondary conduit 1002. In some embodiments, a transition or step 218 is defined by a change in diameter between the valved conduit prosthesis 100 and the secondary conduit 1002 on the inner surface 110 of the valved conduit upstream and / or downstream of the leaflet 106 for a specific purpose. As further described below, the step 218 can prevent pannus overgrowth or other blood or tissue products from encroaching on the leaflet 106.

[0104] For reference Figure 3 Further described, the inner surface 110 of the conduit 102 remains smooth, meaning that the diameter does not change until and away from the position where the leaflet 106 protrudes from the inner surface 110 and enters the conduit lumen 122. The conduit 102 defines a slit 434 operable to allow the leaflet 106 to penetrate the conduit wall 124 and extend into the conduit lumen 122, while simultaneously engaging with the outer surface 320 at the leaflet attachment portion 322 of the conduit 102.

[0105] One advantage of external attachment of leaflet 106 is that it minimizes any flow disturbances and any resulting thrombosis that may occur within the valved conduit prosthesis 100, whereas internal attachments accommodate flow disturbances. For example, if the attachment tab 542 were attached to the inner surface 318 of conduit 102, the attachment tab 542 would be exposed to blood flow and cause flow disturbances.

[0106] In some embodiments, the inner surface 110 of the pipe 102 is constant in diameter, such as... Figure 1B and 3 As shown in the diagram. Additionally, the leaflet 106 can be positioned within the conduit 102 at a longitudinal position along the length of the conduit 102 (e.g., as shown in the diagram). Figure 1A (as shown in the diagram), and the conduit 102 is located in the longitudinal position of the leaflet 106 and is constant in diameter through the adjacent proximal and distal portions of the conduit 102.

[0107] like Figure 1B and 1C As shown, the joining gap 114 is located at each joining 116 between a pair of leaflets 106. Joining 116 is the location on the inner surface 110 of the conduit closest to the pair of leaflets 106 at the free edge 107 of the leaflet, as... Figures 4A to 4CThe plateau 112 is shown as defining the closure gap 114. When the leaflet 106 is closed, the closure gap 114 allows retrograde flow through the conduit 102. Retrograde flow reduces the chance of blood stagnation behind the leaflet 106, which could potentially lead to thrombosis. The size of the closure gap 114 is set to minimize leakage caused by retrograde flow and not to additionally increase stress on the patient's heart to pump blood through the conduit 102. The closure gap 114 is associated with the plateau 112 in the conduit 102, as shown in... Figures 4A to 4C As detailed in the text, it refers to the space between the nearest adjacent slits 434.

[0108] Figure 2 This is an illustration 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 defining an inflow end 213 and an outflow portion 214 defining an outflow end 215. As indicated by the arrows on the conduit 102, the valve structure 104 is configured to allow blood to flow from the inflow portion 212 through the conduit 102 to the outflow portion 214, and to prevent blood from flowing from the outflow portion 214 back to the inflow portion 212. The arrows may be design features printed on the conduit 102 to indicate the direction of blood flow within the conduit 102, thereby guiding the physician for implantation. The arrows (direction indicators) may have multiple different shapes, sizes, lengths, or incorporate other considerations.

[0109] As referenced above Figure 1B As mentioned, the valve structure 104 includes one or more leaflets 106. The leaflets 106 are coupled to the conduit 102 and, together 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 an embodiment, the leaflets 106 are attached, adhered, secured, or bonded to the conduit 102 by an adhesive film 216, such as... Figure 3 As shown in the image.

[0110] The adhesive film 216 can be a continuous or discontinuous layer wrapped around the circumference of the pipe 102. The adhesive film 216 can be placed on the dense portion 604 of the pipe 102 (see reference). Figure 3The adhesive membrane 216 may be placed within and / or outside the dense portion 604, or wrapped around the circumference of the conduit 102, provided it is within the valve region 350 of the conduit 102 to attach the leaflet 106 to the outer surface of the conduit 102. In other embodiments, the adhesive membrane 216 may be placed within and beyond the valve region 350 of the conduit 102, and in some embodiments may cover the entire conduit 102. The adhesive membrane 216 may seal the slit 434 to prevent blood leakage through it. The adhesive membrane 216 may hold two conduits mated together at the leaflet, such as, for example, described as a first conduit 102a and a second conduit 102b, as... Figure 4B and 4C As shown in the image.

[0111] Compared to the attachment arrangement that affects the distribution of the inner surface 318, such as Figure 3 As shown, by connecting or attaching the leaflets to the outer surface 320 of the conduit 102 using, for example, adhesives, thermal bonding or chemical bonding, a smooth inner surface 318 and a consistent conduit inner diameter are maintained, and the effective valve orifice area (EOA) is maximized.

[0112] Figure 3 This is a cross-sectional view of a valved conduit prosthesis 100 according to an 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 may correspond to... Figures 4A to 4C The slit 434 shown can result in a discontinuous slit 434, or as... Figure 4B and 4C The diagram shows that the conduit 102 is completely separated into a first conduit 102a and a second conduit 102b. The leaflet attachment portion 322 may be a component of the conduit 102.

[0113] The valved conduit prosthesis 100 also includes a leaflet 106 extending into the conduit 102 and toward the center 108 of the conduit. (See also...) Figure 3 As shown, the leaflet 106 is connected to the outer surface 320 of the conduit 102 via a tab 542. The leaflet 106 includes components disposed outside the conduit 102, passing through the opening 324 and as shown. Figure 3The portion shown within the conduit 102, where the leaflet 125 is defined as the portion of the leaflet 106 extending from the inner surface 318 within the conduit 102. According to this embodiment, the leaflet 106 is attached to the outer surface 320 of the conduit 102 by means of an adhesive film 216, as illustrated in the example. The adhesive film 216 may cover or overlap over the tabs 542 and / or the slits 434 or openings 324. Other attachment methods are contemplated, such as, but not limited to, thermal bonding, adhesive bonding, and mechanical connection. The adhesive film 216 may be arranged within the boundary of the leaflet attachment portion 322. Furthermore, the leaflet attachment portion 322 may be densified, or have more dense material properties, compared to the proximal (or inflow) portion 212 and distal (or outflow) portion 214 of the conduit 102, which are identified as densified portions 604.

[0114] For a specific purpose, the leaflet attachment portion 322 may be densified and / or rigidified relative to the remainder of the conduit 102. For example, but not limited to, the leaflet attachment portion 322 may be provided such that the conduit 102 retains its shape at the valve region 350 during handling and use. By means of other examples, but not limited to, the leaflet attachment portion 322 may be provided to provide a smoother surface texture and / or a reduction in porosity to prevent flow disturbances and / or to prevent inward growth of tissue or pannus. Densification refers to a process, for example, selectively densifying a material at selected locations by heating and / or pressurizing and / or by permeating pores with an elastomer or elastomeric material. In some embodiments, the conduit 102 is formed of expanded polytetrafluoroethylene (ePTFE). For ePTFE materials, which may be relatively porous, the densification process will reduce porosity and / or make the region more rigid.

[0115] The valved conduit prosthesis 100 may further include a flexible membrane 326 and an adhesive membrane 216 arranged circumferentially around the conduit 102. In some embodiments, the flexible membrane 326 may comprise one or more layers of the flexible membrane 326. The flexible membrane 326 may be wound multiple times around the conduit 102 and the adhesive membrane 216. The flexible membrane 326 may be wound as needed to enhance the strength of the conduit 102 and / or the attachment of the valve 106 to the conduit 102 and / or for connecting tabs 542 and / or sealing slits 434 or openings 324 to prevent leakage, and / or to hold two conduits mated at the valve 106 together, for example, described as a first conduit 102a and a second conduit 102b, as... Figure 4B and 4C As shown in the figure. The adhesive film 216 may be present at the leaflet attachment portion 322 of the conduit 102 (e.g., reference). Figure 3(Discussion) and / or placed or wrapped around the circumference of the conduit 102 outside the leaflet attachment portion 322, as long as it is within the valve region 350 of the conduit 102 to attach the leaflet 106 to the outer surface 320 of the conduit 102. In other embodiments, the adhesive film 216 may be placed within and beyond the valve region 350 of the conduit 102, and in some embodiments may cover the entire conduit 102.

[0116] The flexible membrane 326 enhances the longitudinal tensile strength of the conduit 102, for example, by increasing the column strength of the conduit 102. The flexible membrane 326 can, for example, be used to ensure that the leaflet 106 is secured to the outer surface 320 of the conduit 102. In some embodiments and as described above, the conduit 102 can be ePTFE. Particularly suitable are ePTFE vascular grafts with tensile / elastic behavior, as they provide variable lengths with resistance to bending / kinking. In this respect, the outer surface 320 of the conduit 102 can be stretched to conform to anatomy without kinking the inner surface 318 (luminal flow surface) of the conduit 102, and therefore the conduit lumen 122. The flexible membrane 326 can also be ePTFE, wherein the adhesive membrane 216 is fluorinated ethylene propylene (FEP). By combining the flexible membrane 326 and the adhesive membrane 216, the leaflet 106 can be bonded (e.g., thermally) to the conduit 102.

[0117] In some embodiments, the valved conduit prosthesis 100 may further include a support frame 328, which is attached to the outer surface 320 of the conduit 102 by a flexible membrane 326 or by other means such as thermal, adhesive, mechanical, and frictional methods. The support frame 328 can prevent compression or additionally reduce the compressibility of the conduit 102 and valve structure 104 due to anatomical compressive forces and / or manipulative forces. Additionally, in some embodiments, the support frame 328 is formed of polyetheretherketone (PEEK). In these cases, the support frame 328 is radiopaque, thus allowing the physician to better visualize the position of the leaflets 106 and leaflet attachment portions 322 compared to when the support frame 328 is formed of other materials that would interfere with visualization. Visualizing the leaflets 106 and / or leaflet attachment portions 322 enhances the physician's ability to accurately locate and place the conduit 102 in the target position. In other cases, the support frame 328 is formed of a radiopaque material to aid in the placement or positioning of the implant postoperatively. In other cases, the support frame 328 is metal, such as stainless steel, which can present a lower profile (e.g., thinner) of the outer surface 320 of the pipe 102, such as... Figure 11 As shown, it also provides crush resistance relative to another material.

[0118] The support frame 328 can be either radiopaque or radiopaque. In some cases, the valved conduit prosthesis 100 may include one or more radiopaque markers 330 to aid in postoperative visualization of the valve region 350 of the conduit 102 under fluoroscopic visualization. One or more radiopaque markers 330 may be arranged adjacent to the leaflet 106 on the outer surface 320 of the conduit 102. In some embodiments and as described above... Figure 3 As shown, the valved conduit prosthesis 100 may include radiopaque markings 330 on either side of the longitudinal direction of the leaflet 106 and the leaflet attachment portion 322, and may be placed radially aligned with the leaflet 106 (e.g., but not limited to the ligature 116) to aid in flow visualization and flow analysis. In this way, the physician has markings for more specifically placing or positioning the leaflet 106 and the leaflet attachment portion 322 at target locations. In some embodiments, the radiopaque markings 330 are continuous or discontinuous strips of radiopaque material (e.g., gold) wrapped around or placed around the circumference of the conduit 102.

[0119] Figure 4A This is an illustration of a cut pattern 432 of a conduit 102 used in a flap conduit prosthesis 100 according to an embodiment utilizing a single conduit assembly. The cut pattern 432 includes a plurality of individual slits 434 (e.g., forming...). Figure 3 (Opening 324 shown). Slit 434 corresponds to the connection to pipe 102. Figure 3 The multiple leaflets 106 are shown. Figure 4A As shown, the plurality of slits 434 defined by the cutting pattern 432 are not interconnected. Therefore, the pipe 102 is not divided into multiple parts during assembly and utilizes a single pipe assembly. Although Figure 4A Two slits 434 are shown, but the cutting pattern 432 can have additional slits (e.g., three slits, four slits, etc., as in a tricuspid or tricuspid lobe). Slits 434 can be formed by laser cutting, manual cutting, or other similar methods. Figures 4A to 4C In the illustrated embodiment, each slit 434 defines a parabolic shape, wherein the corresponding leaflet 106 will have a parabolic shape, wherein it penetrates the conduit 102 at the inner surface 318. In other embodiments, each slit 434 defines three sides of an isosceles trapezoid to define the leaflet 106, which, as shown, has a flat base and two straight edges, wherein the valve region 350 is longitudinally cut and opened and placed flat. Figure 5 The tabs 542 and 544 shown can pass through the slit 434 from the inside of the pipe 102 and be secured to the outer surface 320, as... Figure 6C As shown in the image.

[0120] Slit 434 is separated by platform 112, wherein two leaflets 106 are closely approximated, thereby defining junction 116. As described above, slit 434 corresponds to the number of leaflets (not shown) connected to conduit 102. Platform 112 corresponds to junction 116 (as shown). Figure 1B As shown in the diagram, this refers to the spacing between the leaflets 106 within the conduit 102. When the leaflets 106 are in the closed position (e.g., the valve structure is closed), there is a space between the leaflets 106, namely the closure gap 114, as shown in the diagram. Figure 1B As shown in the diagram. Similarly, the leaflets 106 are then in the open position, with a space between the leaflets 106, namely the engagement gap 114, as shown. Figure 1C As shown in the diagram. Slit 434 and platform 112 correspond to the number of leaflets connected to conduit 102. When the leaflets are in the closed position, the closure gap 114 allows blood to flush the area behind leaflets 106. The retrograde or reflux flow through the closure gap 114 reduces the chance of blood stagnation behind leaflets 106, which could potentially lead to thrombosis. The size of the closure gap 114 is set such that the resulting retrograde flow is minimal and does not additionally increase the stress on the patient's heart to pump blood through conduit 102. When leaflets 106 are in the open position, the closure gap 114 can also increase the fluid flow at the closure, for example, but not limited to, ensuring that there is no blood stagnation between the two closely opposing leaflet surfaces, which could occur without the closure gap 114.

[0121] Figure 4B This is an illustration of a cut pattern 436 of the conduit 102 used in a flap conduit prosthesis 100 according to an embodiment. Cut pattern 436 includes a plurality of individual slits 434, wherein the number of slits 434 corresponds to the number of flaps (not shown) to be attached to the conduit 102. Cut pattern 436 also includes transverse cuts 438 in the conduit 102, which allow the conduit 102 to be divided into two conduit assemblies for assembly, i.e., as... Figure 4B The first conduit 102a and the second conduit 102b are shown. A transverse cut 438 is arranged near, adjacent to, or at the midpoint of the longitudinal portion of the slit 434. The transverse cut 438 and the slit 434 can be formed by laser cutting, manual cutting, or other similar methods. Although Figure 4B The diagram shows two slits 434, but the cutting pattern 436 may have additional slits (e.g., three slits, four slits, etc., used in the tricuspid valve for the 106 leaflet valve).

[0122] The slits 434 and the transverse cuts 438 correspond to the number of leaflets connected to the pipe 102. Similar to... Figure 4AThe slit 434 is separated by platform 112. Platform 112 corresponds to the interval between leaflets 106 within conduit 102 (e.g., at the junction). When leaflets 106 are closed (e.g., valve closure), there is a space between the leaflets, namely the junction gap 114, as... Figure 1B As shown in the diagram. When the leaflets are in the closed position as described above, the syndesmotic gap 114 allows blood to flush the area behind the leaflets. This retrograde flow reduces the chance of blood stagnation behind the leaflets 106, which could potentially lead to thrombosis. The size of the syndesmotic gap 114 is configured to minimize the resulting retrograde flow and not additionally increase stress on the patient's heart to pump blood through the conduit 102. When the leaflets 106 are in the open position, the syndesmotic gap 114 can also increase fluid flow at the syndesm, for example, but not limited to, ensuring that there is no blood stagnation between the two closely opposing leaflet surfaces, which could occur without the syndesmotic gap 114.

[0123] Figure 4C This is an illustration of another exemplary cut pattern 440 of the conduit 102 used in a flap conduit prosthesis according to an embodiment.

[0124] The cutting pattern 440 includes a plurality of individual slits 434, wherein the number of slits corresponds to the number of leaflets (not shown) to be connected to the pipe 102. The cutting pattern 440 also includes transverse cuts 438, which are also cuts in the pipe 102, enabling the pipe 102 to be cut into two pipe assemblies for assembly, such as... Figure 4C As shown, the pipe assembly defines a first pipe 102a and a second pipe 102b. The transverse cut 438 and slit 434 can be formed by laser cutting, manual cutting, or other similar methods. Although Figure 4B Two slits 434 are shown, but the cutting pattern 440 may have additional slits (e.g., three slits, four slits, etc. for the tricuspid valve).

[0125] As described above, the slits 434 and the transverse cuts 438 correspond to the number of leaflets that will be connected to the pipe 102. Similar to... Figure 4A The slit 434 is separated by platform 112. Platform 112 corresponds to the closure gap 114, which is the interval between the leaflets in the conduit 102 when the valve is closed (e.g., maintaining the closure gap 114 when the leaflets are in the closed position).

[0126] Figure 5 This refers to the leaflet 106, which can be used in embodiments of the valved conduit prosthesis 100 according to the example. For example... Figure 5As shown, the leaflet 106 may include a plurality of lobes 542 extending from and defining the leaflet 125. The lobes 542 can be formed by cutting slits in the edge of the leaflet 106. The leaflet 106 is formed of a sheet-like material as discussed below. (See reference...) Figure 6A -C further illustrates that the tab 542 can be used to attach the leaflet 106 to the outer surface 320 of the conduit 102, as well as... Figure 3 As shown in the image.

[0127] In some embodiments, leaflet 106 includes alignment tabs 544, which are tabs 544 adjacent to the free edge 107 of the leaflet. Alignment tabs 544 are formed in the same manner as tabs 542. When present in leaflet 106, alignment tabs 544 serve to engage conduit 102 to aid in aligning leaflet 106 with conduit 102 at engagement 116.

[0128] Figure 6A This is an illustration of an exemplary step for attaching the leaflet 106 to the conduit 102 according to an embodiment. For ease of illustration, the outflow portion 214 of the conduit 102 is shown... Figure 6A As shown in the reference, however, Figure 4A As mentioned, the pipe 102 and the leaflet 106 can be connected together without dividing the pipe 102 into multiple sections.

[0129] Leaflets 106 are aligned with slits 434 in conduit 102. As described above, multiple leaflets 106 can be connected to conduit 102. For ease of illustration, Figure 6A The section to C describes the attachment of a single leaflet 106 to the conduit 102. In some embodiments, the conduit 102 includes an alignment line 646 extending longitudinally along the conduit 102. The alignment line 646 facilitates the alignment of the leaflet 106 within the conduit 102. In some embodiments, the leaflet 106 includes alignment tabs 544 arranged relative to the alignment line 646 to ensure that the geometry and alignment of the leaflet 106 within the conduit 102 are appropriate. In other embodiments, a slit 434 at the junction 116 assists in aligning the leaflet 106 to the conduit 102.

[0130] Once the leaflet 106 is aligned with the slit 434, the tab 542 can be folded onto the outer surface 306 of the conduit 102. For example... Figure 6B As shown, the alignment tab 544 can be folded to align with the alignment line 646.

[0131] like Figure 6CAs shown, tabs 542 can be folded in different directions. For example, alternating protrusions 542 can be folded against the outer surfaces 320 of the proximal (or inflow) portion 212 and the distal (or outflow) portion 214 of the conduit 102. Tabs 542 (and alignment tabs 544) are also referred to as conduit attachment sections of leaflets 106, which can be bonded by, for example but not limited to, adhesives, thermal bonding, or chemical bonding (e.g., as referenced above). Figures 6A to 6C (Detailed description) Connected to the outer surface 320 of the conduit 102. The flaps 542 of the leaflets 106 extend through a slit 434 defined in the conduit 102 between the proximal (or inflow) portion 212 and the distal (or outflow) portion 214 (e.g., as shown in the image). Figure 3 (as shown in the diagram). The remainder of the leaflet 106, namely the ventral part 125, extends into the lumen 122 of the conduit 102, which is operable to serve as a valve in the valved conduit prosthesis 100.

[0132] Figure 7 This is a cross-sectional view of another exemplary valved conduit prosthesis 100 according to an embodiment, wherein the inlet end 213 defines an outwardly tapering portion 128 or is operable to taper outwardly. This outwardly tapering portion 128 can facilitate surgical attachment of the inlet end 213 to an anatomical structure.

[0133] Figure 8 This is a cross-sectional view of another exemplary valved conduit prosthesis 100 according to an embodiment, wherein the inflow portion 212 is operable to be flipped outward toward the valve structure 104 and rolled up to define a suture closure 130. The suture closure 130 can facilitate surgical attachment of the inflow portion 212 to the anatomical structure.

[0134] Figure 9 This is a side view of the valved pipe assembly 1000 according to an embodiment. Figure 10 This is a longitudinal cross-sectional view. This embodiment may be referred to as a valved conduit within a secondary conduit, or otherwise as a valved conduit assembly 1000. In essence, these embodiments comprise any of the foregoing embodiments of the valved conduit prosthesis 100, or a portion of the valved conduit prosthesis 100 containing the valve region 350, hereinafter referred to as... Figure 10 and 11 The flapped pipe subassembly 101 shown is disposed within the secondary pipe 1002. According to an embodiment and with reference to... Figure 3The valved conduit assembly 1000 / valve-mounted conduit subassembly 101 includes a valve region 350, which includes a densified portion 604 of the conduit 102, a leaflet 106, and a support frame 328. The conduit 102 is hereinafter referred to as the primary conduit 102 to distinguish it from the secondary conduit 1002 on which the valve-mounted conduit subassembly 101 is disposed. The primary conduit 102 includes a primary conduit outer surface 320 and a primary conduit inner surface 318 defining a primary conduit lumen 122. The primary conduit 102 is shorter than the secondary conduit 1002. The valve-mounted conduit subassembly 101 / valve region 350 is disposed within the secondary conduit lumen 1003 of the secondary conduit 1002 and is coupled to the secondary conduit inner surface 1100 of the secondary conduit 1002. According to an embodiment, the secondary conduit 1002 is a tubular member with elastic properties, such that the secondary conduit 1002 conforms to the external contour of the valved conduit subassembly 101 / valve region 350. The valved conduit subassembly 101 / valve region 350 can be secured within the secondary conduit 1002 by, for example, any friction between the secondary conduit 1002 and the valve region 350, via thermal bonding processes, mechanical components, and adhesives. In other embodiments, the secondary conduit 1002 includes a wound structure wound into a tubular shape, containing the valved conduit subassembly 101 / valve region 350.

[0135] exist Figure 10 In the embodiment shown, the support frame 328 is disposed between the primary conduit 102 and the secondary conduit 1002. It should be understood that in other embodiments, the support frame 328 may be absent, or the support frame may be disposed around the outer surface of the secondary conduit 1002 and positioned around a longitudinal axis coinciding with the valve region 350, operable to provide radial support to the valve region 350.

[0136] Figure 10The diagram illustrates a step 218 or discontinuity on the inner surface 2013 of the secondary conduit, defined by the inflow portion 212 and the outflow portion 214 of the valved conduit subassembly 101 / valve region 350, due to the secondary conduit 1002 having a larger inner diameter compared to the inner diameter of the valved conduit subassembly 101 / valve region 350. For a specific purpose, the step height 1010 and the distance between the step 218 and the leaflet 106, referred to as the upstream length 1012, are predetermined, wherein the leaflet 106 intersects with the densified portion 604. For example, the step 218 may have a step height 1010, which can operate as a barrier to prevent pannus or other biological material from advancing into the upstream or downstream portion of the valved conduit subassembly 101 / valve region 350 and into the leaflet 106. In conjunction with the step height 1010, the upstream length 1012 is sized such that any pannus at step 218 that might generate a valve beyond step 218 will not interfere with the leaflet 106. For example, the upstream length 1012 can have a dimension of 0.1 mm to 3 mm, and the step height 1010 can have a dimension of 0 mm to 3 mm. For example, the valved conduit subassembly 101 / valve region 350 can have an inner diameter of 16.5 mm, and the secondary conduit can have an inner diameter of 18 mm, wherein the step height 1010 can have a nominal dimension of 0.8 mm. It should be understood that the step height 1010 will present a trade-off when the benefit of step 218 becoming a barrier to pannus overgrowth and a cause of flow disturbance becomes greater.

[0137] It should be understood that step 218 can define multiple geometric shapes. For example, such as Figure 10 As shown, step 218 is defined by the inflow portion 212 and the outflow portion 214 at a 90-degree angle to the inner surface 2012 of the secondary conduit. It should be understood that step 218 may alternatively define different geometries, such as, but not limited to, rounded, tapered, and other curved or straight forms. For example, the relatively flexible secondary conduit 1002 may exhibit a curved or circular geometry when stretched and conform to the shape of the valved conduit subassembly 101 / valve region 350.

[0138] In embodiments of the flap-type pipe assembly 1000, it should be understood that if a leak exists at opening 324, such as Figure 3 As best shown in the diagram, the fluid path remains within the lumen of the secondary conduit 1002. This is consistent with... Figure 3 The path formation shown is contrasted in the flapped tube prosthesis 100.

[0139] Figure 11The secondary conduit 1002 exhibits a step 218 or discontinuity on the inner surface defined by the inflow portion 212 and the outflow portion 214 of the valve region 350, due to the elasticity of the outer surface 320 conforming to the valve conduit subassembly 101 / valve region 350, but departing from the step 218 at the leading and trailing edges of the inflow and outflow portions 214. The inner diameter of the valve region 350 is the same as the inner diameter of the secondary conduit 1002 located away from the leading and trailing edges of the inflow and outflow portions 212 and 214, respectively. The size, depth, and / or length of the step 218 or gap are predetermined for specific purposes, such as, but not limited to, preventing excessive pannus growth, as provided above.

[0140] The valved conduit prosthesis discussed in this article is used to replace diseased anatomical structures during surgical procedures. Prior to implantation, the valved conduit prosthesis can be flushed in saline and does not require pre-coagulation. According to one treatment approach, the valved conduit prosthesis is used, for example, to replace the aortic valve and a portion of the ascending aorta during aortic root replacement. Implantation of the valved conduit prosthesis involves identifying the inflow and outflow portions of the conduit, positioning it relative to the intended anatomical structure, and optionally trimming the inflow and / or outflow conduit to the appropriate implantation length under moderate tension. The ascending aorta is incised, and the inflow portion and / or inflow end of the valved conduit prosthesis is sutured or otherwise connected 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 incised ascending aorta. This allows the coronary arteries to remain on the ascending aorta, or they can be sutured to the outflow portion of the conduit, providing a flow path from the conduit lumen to the coronary arteries.

[0141] According to another treatment approach, when partial or complete reconstruction of the right ventricular outflow tract and / or the main pulmonary artery is desired, the valved conduit prosthesis 100 can be a replacement for a natural pulmonary valve or a previously implanted valved conduit prosthesis for the pulmonary artery. In some cases, implantation of the valved conduit prosthesis involves identifying the inflow and outflow portions of the conduit; positioning it relative to the intended location of the coronary artery to ensure no risk of coronary artery compression at implantation; and optionally trimming the inflow and / or outflow conduit to the appropriate implantation length under moderate tension.

[0142] According to another method of treating aortic valve disease by replacing the patient's aortic root, the method includes the following steps: providing a valved conduit prosthesis 100 according to embodiments herein; and surgically implanting the valved conduit prosthesis 100. The method may further include identifying an inflow portion 212 and an outflow portion 214 of the conduit 102; entering a desired location relative to an anatomical structure; optionally trimming the inflow portion 212 and the outflow portion 214 of the conduit to an appropriate implantation length; optionally tapering the inflow end 213 outwards or optionally flipping and rolling up the inflow portion 212 toward the valve structure 104 defining a suture closure 130; incising the ascending aorta; connecting the inflow portion 212 of the valved conduit prosthesis 100 to the left ventricle adjacent to or replacing the resected aortic valve; and connecting the outflow portion 214 of the valved conduit prosthesis 100 to the incised ascending aorta. The method may further include connecting a coronary artery to the outflow portion 214 of the conduit 102; and establishing a flow path from the conduit lumen 122 to the coronary artery. The method may further include connecting the coronary artery 12 to a sinus defined by the outflow portion.

[0143] Petal material

[0144] Extended fluoropolymer membranes can include any suitable microstructure, such as pores, to achieve the desired leaflet performance. Other biocompatible polymers suitable for use in leaflets include, but are not limited to, urethanes, organosilicones (organopolysiloxanes), copolymers of silicon-urethanes, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures thereof.

[0145] In various instances, any of the leaflets 106 described herein (e.g., leaflet structures) can be formed from biocompatible synthetic materials (e.g., materials comprising ePTFE and ePTFE composites, or other materials as needed). Other biocompatible polymers suitable for synthesizing leaflets include, but are not limited to, urethanes, organosilicones (organopolysiloxanes), copolymers of silicon-urethanes, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures thereof.

[0146] In other instances, this leaflet structure is formed from natural materials, such as recycled tissues, including bovine tissue, porcine tissue, etc.

[0147] The term "elastomer" refers to a polymer or mixture of polymers that can stretch to at least 1.3 times its original length and rapidly retract to approximately its original length upon release.

[0148] The term "elastic material" refers to a polymer or mixture of polymers that exhibits tensile and recovery properties similar to those of an elastomer, but not necessarily the same degree of tensile and / or recovery.

[0149] The term "inelastic material" refers to a polymer or mixture of polymers that does not exhibit tensile and recovery properties similar to those of an elastomer or elastic material, i.e., it is not considered an elastomer or elastic material as commonly known.

[0150] According to embodiments herein, leaflet 106 comprises a composite material having at least one porous synthetic polymer membrane layer having a plurality of pores and / or spaces and an elastomeric and / or elastic material and / or non-elastic material filling the pores and / or spaces of the at least one synthetic polymer membrane layer. According to other embodiments, leaflet 106 further comprises layers of elastomeric and / or elastic material and / or non-elastic material on the composite material. According to embodiments, the composite material comprises a porous synthetic polymer membrane ranging from 10% to 90% by weight.

[0151] Examples of porous synthetic polymer membranes include expanded fluoropolymer membranes with nodes and fibrillary structures defining pores and / or spaces. In some examples, the expanded fluoropolymer membrane is an expanded polytetrafluoroethylene (ePTFE) membrane. Another example of porous synthetic polymer membranes includes microporous polyethylene membranes and expanded polyethylene.

[0152] Examples of elastomers and / or elastic and / or non-elastic materials include, but are not limited to, copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE / PMVE copolymers), (per)fluoroalkyl vinyl ethers (PAVE), urethanes, organosilicon (organopolysiloxanes), silicone-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and copolymers or mixtures thereof. In some examples, the TFE / PMVE copolymer is an elastomer comprising 60 to 20 wt% tetrafluoroethylene and 40 to 80 wt% perfluoromethyl vinyl ether. In some examples, the TFE / PMVE copolymer is an elastic material comprising 67 to 61 wt% tetrafluoroethylene and 33 to 39 wt% perfluoromethyl vinyl ether. In some examples, the TFE copolymer is a non-elastic material comprising 73 to 68 wt% tetrafluoroethylene and 27 to 32 wt% perfluoromethyl vinyl ether. The TFE and PMVE components of the TFE-PMVE copolymer are expressed in wt%. For reference, 40, 33 to 39, and 27 to 32 wt% of PMVE correspond to 29, 23 to 28, and 18 to 22 mol%, respectively.

[0153] In some instances, TFE-PMVE copolymers exhibit elastomeric, elastic, and / or inelastic properties.

[0154] In some instances, the composite material further comprises a layer or coating of a TFE-PMVE copolymer comprising 73 to 68 wt% tetrafluoroethylene and 27 to 32 wt% perfluoromethyl vinyl ether, respectively.

[0155] In some instances, leaflet 106 is an expanded polytetrafluoroethylene (ePTFE) membrane that has been permeated with a TFE-PMVE copolymer comprising 60 to 20 wt% tetrafluoroethylene and 40 to 80 wt% perfluoromethyl vinyl ether, respectively. Leaflet 106 further comprises a coating on the blood contact surface comprising a TFE-PMVE copolymer comprising 73 to 68 wt% tetrafluoroethylene and 27 to 32 wt% perfluoromethyl vinyl ether, respectively.

[0156] As discussed above, elastomers and / or elastic and / or non-elastic materials can be combined with expanded fluoropolymer films such that the elastomers and / or elastic and / or non-elastic materials occupy substantially all of the void spaces or pores within the expanded fluoropolymer film.

[0157] Although some examples of suitable leaflet materials have been provided, the foregoing examples are not intended to be read in a restrictive sense, and additional or alternative materials are envisioned.

[0158] The inventive features of this disclosure have been described above generally and with respect 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 this disclosure. Therefore, it is contemplated that the embodiments cover modifications and variations of this disclosure, provided that such modifications and variations are within the scope of the appended claims and their equivalents.

Claims

1. A valved conduit prosthesis, comprising: Secondary conduit, the secondary conduit having a secondary conduit inner surface, the secondary conduit inner surface defining a secondary conduit lumen therethrough; and A flapped pipe subassembly, the flapped pipe assembly comprising: A primary conduit having an outer surface and an inner surface, the inner surface defining a lumen and a slot therethrough; as well as At least one leaflet has an external portion connected to the outer surface of the primary conduit and an internal portion disposed within the lumen of the primary conduit to be operable as a one-way valve, the leaflet defining the valve structure. The flapped pipe subassembly is located within the secondary pipe cavity and connected to the inner surface of the secondary pipe, and the flapped pipe subassembly and the inner surface of the secondary pipe define at least one step; and The step has a step height defined at the step by the inner surface of the primary conduit and the inner surface of the secondary conduit, wherein the step height is operable as a barrier to prevent pannus or other biological material from advancing into the upstream or downstream portion of the valved conduit subassembly.

2. The valved conduit prosthesis of claim 1, wherein the outer portion of the at least one valve leaflet is adhered to the outer surface of the primary conduit by adhesive, thermal bonding or chemical bonding.

3. The valved conduit prosthesis according to claim 1, wherein the outer portion of the at least one valve leaflet is attached to the outer surface of the primary conduit via an adhesive film layer.

4. The valved tube prosthesis of claim 1, wherein the at least one step is defined by the secondary tube having an inner diameter larger than that of the valved tube subassembly.

5. The valved tube prosthesis of claim 1, wherein the valved tube subassembly defines an upstream length between the valve leaflet and the step, wherein the upstream length has a dimension of 0.1 mm to 3 mm, and the step height has a dimension of greater than 0 mm and less than or equal to 3 mm.

6. The valved conduit prosthesis according to any one of claims 1 to 5, wherein the valved conduit has an inflow portion defining an inflow end and an outflow portion defining an outflow end, wherein the at least one valve connected to the primary conduit is operable to open under forward flow conditions to allow flow from the inflow end through the outflow end, and operable to close under reverse flow conditions to restrict flow from the outflow end through the inflow end.

7. The valved tube prosthesis according to any one of claims 1 to 5, wherein the at least one valve leaflet comprises a composite material, the composite material comprising a porous synthetic fluoropolymer membrane defining pores and an elastomer or elastic material filling the pores. And a TFE-PMVE copolymer comprising, in at least a portion thereof, 27 to 32 wt% of perfluoromethyl vinyl ether and 73 to 68 wt% of tetrafluoroethylene, Furthermore, the elastomer or elastic material includes a TFE-PMVE copolymer. Furthermore, the porous synthetic fluoropolymer membrane is ePTFE.

8. The valved conduit prosthesis according to any one of claims 1 to 5, wherein the at least one valve comprises more than one valve, and the more than one valve is separated from each other by a connecting gap within the inner surface of the primary conduit.

9. The valved conduit prosthesis of claim 8, wherein the at least one valve leaflet is more than one valve leaflet, and the primary conduit includes a platform separating each valve leaflet at a conduit attachment section of each valve leaflet to form the fusion gap between the valve leaflets within the inner surface of the primary conduit.

10. The valved tube prosthesis according to any one of claims 1 to 5, wherein the valved tube subassembly is attached to the inner surface of the secondary tube by adhesive, thermal bonding or chemical bonding.

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