Patent Description:
The present disclosure relates generally to prosthetic valves and more specifically to apparatuses, systems, and methods that include conduits having an expandable frame therein.

Bioprosthetic heart valves have been developed that attempt to mimic the function and performance of a native valve. Flexible leaflets may be mechanically coupled to a relatively rigid frame that supports the leaflets and provides dimensional stability when implanted. Although bioprosthetic heart valves can provide excellent hemodynamic and biomechanical performance in the short term, they are prone to calcification and cusp tears, among other failure modes, requiring reoperation and replacement.

In certain instances, leaflets may be arranged within a conduit, such as a pulmonary valve conduit. However, various situations arise in which the requisite diametric profile of a valved conduit changes from one point in time to another. For example, in pediatric applications, a valve portion of the valved conduit with a first, smaller inner diameter (i.e., the inner flow diameter) may be appropriate, but following growth of the patient, a larger inner diameter for the prosthetic valve is desirable. The removal of an existing valve and/or implantation of another valve with a larger flow diameter may give rise to various complications and concomitant risks. <CIT> discloses apparatuses, systems, and methods for valved conduits and, in particular, a prosthetic valve that includes one or more primary leaflets, and one or more auxiliary leaflets stored in an inactive state, the one or more auxiliary leaflets being configured to release to an active state upon diametrically expanding the prosthetic valve. <CIT> discloses methods and apparatuses relating to an expandable valve that may be implanted within the body, for example, at a semilunar position of the heart. <CIT> discloses a medical set or arrangement comprising at least one expandable and/or decollapsible or unfoldable medical implant and at least one implantation device, for example a catheter, for detachably receiving the implant or a device comprising at least such an implant. <CIT> discloses expandable implantable conduits and expandable bioprosthetic stented valves. A disclsoed valve may be adapted to accommodate growth of a patient to address limitation on bioprosthetic valve lifespans.

According to the invention, a prosthetic cardiac valved conduit includes a conduit having ar interior surface and an exterior surface; and a frame element arranged within the conduit and having commissure posts arranged about the frame element, the frame element having a first diameter in a first configuration and configured to support a valve structure having leaflets configured to open to permit flow and close to occlude a conduit lumen and prevent flow in response to differential fluid pressure and to expand to a second, larger diameter in a second configuration in response to a force applied to an interior portion of the frame element; and one or more expansion elements arranged between or adjacent to the commissure posts and configured to spread apart to radially expand the frame element in transitioning between the first configuration and the second configuration.

According to an embodiment, the frame element is configured to house a second valve structure therein in the second configuration.

According to the invention, the frame element includes a first circular rim and a second circular rim connected by the commissure posts, and the one or more expansion elements form portions of at least one of the first circular rim and the second circular rim.

According to another embodiment, the one or more expansion elements are arranged with one of the first circular rim and the second circular rim and extend toward another of the first circular rim and the second circular rim.

According to another embodiment, the one or more expansion elements include a first linear portion, a second linear portion, and a curved portion.

According to another embodiment, the first linear portion and the second linear portion extend substantially parallel with a longitudinal axis of the frame element in the first configuration and are configured to angle relative to the longitudinal axis of the frame element in the second configuration.

According to another embodiment, the one or more expansion elements are arranged between the commissure posts.

According to another embodiment, the one or more expansion elements are arranged adjacent to the commissure posts.

According to another embodiment, the one or more expansion elements are arranged between portions of the commissure posts.

According to another embodiment, the frame element includes a plurality commissure posts and the one or more expansion elements includes a plurality of expansion elements arranged between portions of each of the commissure posts.

According to another embodiment, the valved conduit also includes a plurality of additional expansion elements arranged between the commissure posts.

According to another embodiment, the one or more expansion elements are configured to increase a diameter of the frame element.

The foregoing Embodiments are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple embodiment are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature.

This disclosure is not meant to be read in a restrictive manner. For example, the terminology used in the application should be read broadly in the context of the meaning those in the field would attribute such terminology.

With respect to terminology of inexactitude, the terms "about" and "approximately" may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement. Measurements that are reasonably close to the stated measurement deviate from the stated measurement by a reasonably small amount as understood and readily ascertained by individuals having ordinary skill in the relevant arts. Such deviations may be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, minor adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like, for example. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms "about" and "approximately" can be understood to mean plus or minus <NUM>% of the stated value.

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

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

Various aspects of the present disclosure are directed toward apparatuses, 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, replace a pulmonary valve and a portion of the corresponding pulmonary artery. The valve structure includes leaflets operable as a one-way valve with the conduit defining a conduit lumen. The leaflets open to permit flow and close to occlude the conduit lumen and prevent flow in response to differential fluid pressure. In addition, the conduit includes a frame element that supports the valve structure. In certain instances, the patient having the conduit may grow out of the conduit such that the valve structure is no longer functional or is not functioning as desired. As discussed in further detail below, the frame element may be configured to expand to allow for a second valve structure to be installed within the frame element / valve structure of the conduit. The second valve structure may be a prosthetic valve that can be deployed in place of the previously deployed valve structure (within the conduit).

Embodiments herein include various apparatuses, 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, replace an aortic valve and a portion of the aorta, such as the ascending aorta. The conduit is operable to be surgically coupled to the left atrium at a conduit proximal end and to a portion of the ascending aorta as a conduit distal end. In other embodiments, the conduit is also operable for the urgical attachment of one or more coronary arteries thereto to establish blood flow thereto.

<FIG> is an illustration of an example valved conduit <NUM>, in accordance with an embodiment. The valved conduit <NUM> includes a conduit <NUM> with a valve structure <NUM> arranged within the conduit <NUM>. The conduit <NUM> may include an upstream end and a downstream end such that the valve structure <NUM> allows flow in one direction.

The valved conduit <NUM> may be used, in a non-limiting example, to replace an aortic valve and at least a portion of the ascending aorta. In one nonlimiting example, the valved conduit <NUM> may be indicated for the correction or reconstruction of the aortic root and aortic valve, i.e., aortic root replacement, in pediatric patients. The valved conduit <NUM> may also be indicated for the replacement of previously implanted homografts or valved conduits that have become dysfunctional or insufficient.

The valved conduit <NUM> may be used, in a non-limiting example, as a shunt for connecting of the right ventricle to the pulmonary artery following a Norwood operation, as frequently performed for the treatment of hypoplastic left heart syndrome. In one non-limiting example, the valved conduit <NUM> may be indicated for the correction or reconstruction of the right ventricle outflow tract (RVOT) in pediatric patients. Such reconstruction may be indicated for congenital heart disorders such as tetralogy of Fallot, Truncus Arterious, Dextro-Transposition of the Great Arteries, Pulmonary Atresia of Intact Ventricular Septum, or Aortic Valvular Disease. The valved conduit <NUM> may also be indicated for the replacement of previously implanted homografts or valved conduits that have become dysfunctional or insufficient. In addition, the valved conduit <NUM> may have applications in treating a wider range of heart disorders, including other areas of the heart. Generally, the term "distal" is used in the disclosure to refer to the outflow end (distal end) or outflow direction of a valved conduit <NUM>, and in turn the term "proximal" is used to refer to the inflow end of a valved conduit <NUM>, or a direction opposite the direction of primary flow through the valved conduit <NUM>.

As shown in <FIG> and in further detail in <FIG>, the valved conduit <NUM> includes a frame element <NUM>. The frame element <NUM> is configured to support the valve structure <NUM> and leaflets <NUM>. The valve structure <NUM> may be formed of silicone or another flexible polymer that is applied to an exterior surface or portion (e.g., outside diameter) of a frame element <NUM>. In certain instances, the conduit <NUM> is formed of a graft material and the frame element <NUM> is the sole supporting structure arranged with the conduit <NUM>. The conduit <NUM>, for example, may be free of stent or stent like features with the exception of the frame element <NUM>.

<FIG> illustrates an interior downstream view of a valve structure <NUM> in a closed configuration, as shown in <FIG>. The valve structure <NUM> includes leaflets <NUM> that extend into an interior of the conduit <NUM>. Although three leaflets <NUM> are shown in <FIG>, the valve structure <NUM> may include one, two, three four, five, six, seven, eight or greater number of leaflets <NUM>. As shown in <FIG>, the leaflets <NUM> close toward a center <NUM> of the conduit <NUM> in the closed configuration. As shown in <FIG>, gaps <NUM> exist between each of the leaflets <NUM>. The gaps <NUM> allow backflow through the conduit <NUM>. The backflow lessens the opportunity for blood to stagnate behind the leaflet <NUM>, which can lead to thrombus formation. The gaps <NUM> are sized such that leakage resulting from the backflow is minimal and does not otherwise increase strain on the patient's heart to pump blood through the conduit <NUM>. In an open configuration, blood may flow through the valve structure <NUM> with the leaflets <NUM> being forced toward an interior surface <NUM> of the conduit <NUM>. The leaflets <NUM> may be coupled to the frame element <NUM> as described in <FIG>. The leaflets <NUM> are configured open to permit flow and close to occlude the conduit lumen and prevent flow in response to differential fluid pressure.

<FIG> is a cross-sectional illustration of a conduit <NUM>, frame element <NUM> and valve structure <NUM>, in accordance with an embodiment. The valve structure <NUM>, which may include the frame element <NUM>, is arranged within the conduit <NUM> such that the leaflets <NUM> extend into the conduit <NUM> and toward the center <NUM> of the conduit <NUM>. The valve structure <NUM> may be coupled or adhered the frame element <NUM> and/or the conduit <NUM>.

In certain instances, the conduit <NUM> may include one or more radiopaque markers <NUM> to assist in visualizing a location of the frame element <NUM> within the conduit <NUM> post-procedure under fluoroscopic visualization. The one or more radiopaque markers <NUM> can be arranged adjacent to the frame element <NUM>. In other instances, the conduit <NUM> does not include any radiopaque markets <NUM> as the frame element <NUM> may be radiopaque.

The frame element <NUM>, as discussed in further detail below, is configured to support the valve structure <NUM> and leaflets <NUM> in a first configuration as shown in <FIG>. The frame element <NUM> includes one or more expansion elements <NUM> that are configured to spread apart to radially expand the frame element <NUM> to a second configuration having a diameter larger than a diameter of the frame element <NUM> in the first configuration. The one or more expansion elements <NUM> are configured to expand a diameter of the frame element <NUM> such that a secondary valve structure may be arranged within the frame element <NUM> in the second configuration.

<FIG> is an example frame element <NUM> in a first configuration, in accordance with an embodiment. The frame element <NUM> is arranged within a conduit <NUM> and configured to support a valve structure <NUM>, as shown above in <FIG>, to form a valved conduit. In other instances not covered by the claims, the frame element <NUM> may be deployed within a patient without being arranged within a conduit. As shown, the frame element <NUM> may define an arcuate or U-shape. The frame element <NUM> also includes commissure posts <NUM>, <NUM>, <NUM>. The number of commissure posts <NUM>, <NUM>, <NUM> (or commissure regions or supports) may be equal to a number of leaflets that of the valve structure <NUM> that the frame element <NUM> is configured to support. As shown in <FIG>, the frame element <NUM> includes three commissure posts <NUM>, <NUM>, <NUM>. The commissure posts <NUM>, <NUM>, <NUM> may provide locations for attachment of leaflets.

In certain instances, the frame element <NUM> is configured to expand to a first diameter shown in <FIG> in the first configuration. In this first configuration, the frame element <NUM> is configured to support a valve structure <NUM> at the first deployed diameter. The valve structure <NUM> and leaflets <NUM> (shown in <FIG>) may open and close when deployed at a target location within a patient such as replacement the pulmonary valve and a portion of the corresponding pulmonary artery.

In certain instances, the valve structure <NUM> and leaflets <NUM> (shown in <FIG>) may no longer function as desired due to growth of the patient, calcification of the leaflets <NUM> or other issues. As a result, the frame element <NUM> is configured to expand to a second, larger diameter in a second configuration (shown in <FIG>) in response to a force applied to an interior portion of the frame element <NUM>. The force may be the result of a balloon to expand the frame element <NUM> or a delivery system carrying a replacement or second valve structure <NUM>. The replacement or second valve structure <NUM> may be deployed within the expanded frame element <NUM>.

To facilitate expansion of the frame element <NUM> (and conduit <NUM> into which the frame element <NUM> may be implanted), the frame element <NUM> includes one or more expansion elements <NUM>, <NUM>, <NUM>, <NUM>. The expansion elements <NUM>, <NUM>, <NUM>, <NUM> may be arranged between one or more of the commissure posts <NUM>, <NUM>, <NUM> and configured to spread apart to radially expand the frame element <NUM> in transitioning between the first configuration and the second configuration. The frame element <NUM> may be configured to house a second valve structure therein in the second configuration. The frame element <NUM> may expand to allow for the second valve structure to be implanted and function without interference from the frame element <NUM>.

The frame element <NUM> includes a first circular rim <NUM> and a second circular rim <NUM> connected by the commissure posts <NUM>, <NUM>, <NUM>. The one or more expansion elements <NUM>, <NUM>, <NUM>, <NUM> form portions of one or both of the first circular rim <NUM> and the second circular rim <NUM>. For ease of illustration, not all expansion elements are identified in <FIG>. As shown, the expansion elements <NUM>, <NUM>, <NUM>, <NUM> form portions of each of the first circular rim <NUM> and the second circular rim <NUM>. In other instances, the expansion elements <NUM>, <NUM>, <NUM>, <NUM> may form a portion of only the first circular rim <NUM> or only the second circular rim <NUM>. In certain instances, the expansion elements <NUM>, <NUM>, <NUM>, <NUM> that form portions of the second circular rim <NUM> may be arranged within portions of the commissure posts <NUM>, <NUM>, <NUM>.

For example, the expansion element <NUM> is arranged within portions of the commissure post <NUM>. The frame element <NUM> may include one expansion element <NUM>, <NUM>, <NUM>, <NUM> with one of the circular rims <NUM>, <NUM>, one expansion element <NUM>, <NUM>, <NUM>, <NUM> with each of the circular rims <NUM>, <NUM>, two expansion elements <NUM>, <NUM>, <NUM>, <NUM> with one of the circular rims <NUM>, <NUM>, two expansion elements <NUM>, <NUM>, <NUM>, <NUM> with each of the circular rims <NUM>, <NUM>, three expansion elements <NUM>, <NUM>, <NUM>, <NUM> with one of the circular rims <NUM>, <NUM>, three expansion elements <NUM>, <NUM>, <NUM>, <NUM> with each of the circular rims <NUM>, <NUM>, combinations of the above (e.g., one with one circular rim <NUM>, and <NUM> and two with the other circular rim <NUM>, <NUM>), and additional expansion elements <NUM>, <NUM>, <NUM>, <NUM>. Thus, the frame element <NUM> may include a plurality of expansion elements <NUM>, <NUM>, <NUM>, <NUM>, which may be arranged between or within commissure posts <NUM>, <NUM>, <NUM>.

In certain instances, the one or more expansion elements <NUM>, <NUM>, <NUM>, <NUM> are arranged with one of the first circular rim <NUM> and the second circular rim <NUM> and extend toward the other of the first circular rim <NUM> and the second circular rim <NUM>. In addition, the expansion elements <NUM>, <NUM>, <NUM>, <NUM>, as highlighted on expansion element <NUM> for ease of illustration, may include a first linear portion <NUM> and a second linear portion <NUM>. In certain instances, the first linear portion <NUM> and the second linear portion <NUM> may be connected or coupled together by another linear portion, a jagged portion, a waved portion, a curved portion or combinations thereof.

As shown in <FIG>, the first linear portion <NUM> and the second linear portion <NUM> are connected by a curved portion <NUM>. The curved portion <NUM> may facilitate expansion and separate of the first linear portion <NUM> and the second linear portion <NUM>. In addition, the curved portion <NUM> may absorb and distribute stress on the frame element <NUM> when expanding and expanded to a larger diameter. In certain instances, the first linear portion <NUM> and the second linear portion <NUM> extend substantially parallel with a longitudinal axis of the frame element <NUM> in the first configuration, as shown in <FIG>, and are configured to angle relative to the longitudinal axis of the frame element <NUM> in the second configuration, as shown in <FIG>. As shown in <FIG>, the frame element <NUM> maintains an uninterrupted or continuous outer perimeter in the second figuration. The expansion elements <NUM>, <NUM>, <NUM>, <NUM> are configured to expand the frame element <NUM> without fracturing or otherwise disrupting physical integrity of the frame element <NUM>.

As noted above, the expansion elements <NUM>, <NUM>, <NUM>, <NUM> are configured to facilitate expansion of the frame element <NUM> between the first configuration, shown in <FIG>, and the second configuration, shown in <FIG>, to increase a diameter of the frame element <NUM>. <FIG> shows the frame element <NUM>, shown in <FIG>, in a second configuration. As shown in the second configuration, the first linear portion <NUM> and the second linear portion <NUM> transition separate and angle to allow the frame element <NUM> to have an expanded diameter. In addition, the expansion elements <NUM>, <NUM>, <NUM>, <NUM> maintain integrity of the frame element <NUM> in the second configuration and in transitioning to the second configuration. In certain instances, the curved portion <NUM> may relieve forces such that the expansion elements <NUM>, <NUM>, <NUM>, <NUM> do not fracture.

In certain instances, the frame element <NUM> having expansion elements <NUM>, <NUM>, <NUM>, <NUM> on each of the first circular rim <NUM> and the second circular rim <NUM> may allow expansion of each of the first circular rim <NUM> and the second circular rim <NUM>. In addition, the first circular rim <NUM> and the second circular rim <NUM> having an equal number of expansion elements <NUM>, <NUM>, <NUM>, <NUM> may facilitate uniform expansion of the frame element <NUM>. In addition and in certain instances, expansion elements <NUM>, <NUM>, <NUM>, <NUM> of the first circular rim <NUM> may be equally spaced about the first circular rim <NUM> and expansion elements <NUM>, <NUM>, <NUM>, <NUM> of the second circular rim <NUM> may be equally spaced about the second circular rim <NUM>. The equal spacing may also facilitate uniform expansion of the frame element <NUM>.

The expansion elements <NUM>, <NUM>, <NUM>, <NUM> may be configured to hold the frame element <NUM> in the second configuration at the diameter intended by the interior radial force. A balloon, for example, may apply an interior force to the frame element <NUM> to expand the frame element <NUM> to a given diameter. After the balloon is no longer inflated, the expansion elements <NUM>, <NUM>, <NUM>, <NUM> hold the frame element <NUM> at the given diameter. More force may expand the frame element <NUM> further. For example, a first force may expand the frame element <NUM><NUM>%, a higher force may expand the frame element <NUM><NUM>%, and an even higher force may expand the frame element <NUM><NUM>% (or greater). The frame element <NUM> may be expanded and held by the expansion elements <NUM>, <NUM>, <NUM>, <NUM> in a sloped manner such that the frame element <NUM> can be linearly or gradually expanded and maintained at a desired diameter. In certain instances, the frame element <NUM> may be between approximately <NUM> and approximately <NUM> in the first configuration, and expanded to approximately <NUM> to approximately <NUM> in the second configuration. The expansion elements <NUM>, <NUM>, <NUM>, <NUM> may be configured to hold the frame element <NUM> at a desired diameter to facilitate housing of a desired size of a secondary valve structure that is arranged within the frame element <NUM> after expansion.

In certain instances, after the valved conduit that includes the frame element <NUM> is arranged within the patient (e. g,, within the heart) and after applying a force interior to the frame element <NUM> to spread apart to radially expand the frame element to a second configuration having a larger diameter than the first configuration, a secondary or replacement valve structure (having leaflets and being similarly configured as the valve structure <NUM>) may be arranged within the expanded frame element <NUM>. The secondary or replacement valve structure may be implanted via a transcatheter approach and function as expanded within the frame element <NUM>.

<FIG> is another example frame element <NUM> in a first configuration, in accordance with an embodiment. The frame element <NUM> may be arranged within a conduit <NUM> and configured to support a valve structure <NUM>, as shown above in <FIG>, to form a valved conduit. In other instances not covered by the claims, the frame element <NUM> may be deployed within a patient without being arranged within a conduit. As shown, the frame element <NUM> may define an arcuate or U-shape. The frame element <NUM> also includes commissure posts <NUM>, <NUM>, <NUM>. The number of commissure posts <NUM>, <NUM>, <NUM> (or commissure regions or supports) may be equal to a number of leaflets that of the valve structure <NUM> that the frame element <NUM> is configured to support. As shown in <FIG>, the frame element <NUM> includes three commissure posts <NUM>, <NUM>, <NUM>. The commissure posts <NUM>, <NUM>, <NUM> may provide locations for attachment of leaflets. The frame element <NUM> includes a first circular rim <NUM> and a second circular rim <NUM> connected by the commissure posts <NUM>, <NUM>, <NUM>.

In certain instances, the frame element <NUM> is configured to expand to a first diameter shown in <FIG> in the first configuration. In this first configuration the frame element <NUM> is configured to support a valve structure <NUM> at the first deployed diameter. The valve structure <NUM> and leaflets <NUM> (shown in <FIG>) may open and close when deployed at a target location within a patient such as replacement the pulmonary valve and a portion of the corresponding pulmonary artery.

To facilitate expansion of the frame element <NUM> (and conduit <NUM> into which the frame element <NUM> may be implanted), the frame element <NUM> includes one or more expansion elements <NUM>, <NUM>, <NUM>, <NUM>. For ease of illustration, not all expansion elements are identified in <FIG>. The expansion elements <NUM>, <NUM>, <NUM>, <NUM> may be arranged adjacent to one or more of the commissure posts <NUM>, <NUM>, <NUM> and configured to spread apart to radially expand the frame element <NUM> in transitioning between the first configuration and the second configuration. As shown, the expansion elements <NUM>, <NUM>, <NUM>, <NUM> are arranged at upper and lower portions of the commissure posts <NUM>, <NUM>, <NUM>. In certain instances, each of the commissure posts <NUM>, <NUM>, <NUM> includes upper and lower expansion elements <NUM>, <NUM>, <NUM>, <NUM>, and in other instances, one or more of the commissure posts <NUM>, <NUM>, <NUM> includes upper and lower expansion elements <NUM>, <NUM>, <NUM>, <NUM>. Further, one or more of the commissure posts <NUM>, <NUM>, <NUM> may include only one of an upper and lower expansion element <NUM>, <NUM>, <NUM>, <NUM>.

Upper expansion elements <NUM>, <NUM> may include a first portion <NUM> and a second portion <NUM>. Each of the first portion <NUM> and the second portion <NUM> of the upper expansion elements <NUM>, <NUM> include arms on either side of an adjacent one of the commissure posts <NUM>, <NUM>, <NUM>. As shown in <FIG>, the arms of the first portion <NUM> and the second portion <NUM> of the upper expansion elements <NUM>, <NUM> separate from the adjacent one of the commissure posts <NUM>, <NUM>, <NUM> in the second (expanded) configuration. The lower expansion elements <NUM>, <NUM> may include accordion-like portions that are collapsed toward an adjacent one of the commissure posts <NUM>, <NUM>, <NUM> in the first configuration. In the second configuration, as shown in <FIG>, the lower expansion elements <NUM>, <NUM> expand outwardly relative to the adjacent one of the commissure posts <NUM>, <NUM>, <NUM>. The accordion-like portions may include curved transitions between the linear shapes. In addition and as shown in <FIG>, either or both of the upper and lower expansion elements <NUM>, <NUM>, <NUM>, <NUM> may include triangular shapes or other curved shapes to facilitate expansion. As shown in <FIG>, the frame element <NUM> maintains an uninterrupted or continuous outer perimeter in the second figuration. The expansion elements <NUM>, <NUM>, <NUM>, <NUM> are configured to expand the frame element <NUM> without fracturing or otherwise disrupting physical integrity of the frame element <NUM>.

The frame element <NUM> having upper and lower expansion elements <NUM>, <NUM>, <NUM>, <NUM> may isolate deformation of the frame element <NUM> to between the commissure posts <NUM>, <NUM>, <NUM>. As a result, the frame element <NUM> is configured to deform to maintain the gaps (as shown in <FIG>) between the leaflets. The upper and lower expansion elements <NUM>, <NUM>, <NUM>, <NUM> may be configured to hold the frame element <NUM> in the second configuration at the diameter intended by the interior radial force. The frame element <NUM> may be expanded and held by the upper and lower expansion elements <NUM>, <NUM>, <NUM>, <NUM> in a sloped manner such that the frame element <NUM> can be linearly or gradually expanded and maintained at a desired diameter.

The frame elements discussed herein may be formed from other materials such as stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other appropriate biocompatible material, and combinations thereof, can be used as the material of the frames. In other instances, the frame elements may be formed from Nitinol (NiTi).

The conduits discussed herein may be a synthetic conduit with at least one flexible synthetic valve leaflet attached to the synthetic conduit. Prior to implantation, the synthetic valve leaflet and/or the synthetic conduit that may be rinsed in saline and does not require pre-clotting. Subsequently, the synthetic valve leaflet and the synthetic conduit may be surgically implanted. The synthetic valve leaflet and the synthetic conduit may be a replacement of the native pulmonary valve or of a previously implanted pulmonary valved conduit where partial or complete reconstruction of the right ventricular outflow tract and/or main pulmonary artery is desired. In certain instances, installation of the synthetic valve leaflet and the synthetic conduit includes identifying the inflow and outflow regions (or ends) of the conduit, accessing the intended position with respect to the coronary arteries to assure there is no risk of coronary compression when implanted, and optionally trimming the inflow end and or outflow end of the conduit, while under moderate tension, to the appropriate length for implantation.

The valved conduit discussed herein is useful for replacing diseased anatomy in a surgical operation. Prior to implantation, the valved conduit may be rinsed in saline and does not require pre-clotting. The valved conduit is useful as a replacement for an aortic valve and a portion of the ascending aorta, such as in an aortic root replacement. Implanting the valved conduit includes identifying the inflow and outflow portions of the conduit, accessing the intended position with respect to the anatomy, and optionally trimming the inflow end or portion and or outflow end or portion of the conduit, while under moderate tension, to the appropriate length for implantation. The ascending aorta is sectioned and the inflow portion and/or inflow end of the valved conduit is sutured or otherwise coupled to the left ventricle adjacent to or in the place of an excised aortic valve. The outflow portion and/or the outflow end of the valved conduit is sutured to the sectioned ascending aorta. Coronary arteries are allowed to remain on the ascending aorta or they may be sutured to the outflow portion of the conduit and a flow path is provided from the conduit lumen to the coronary arteries.

The valved conduit is useful for treating aortic valve disease by replacing the aortic root of a patient, according to a procedure that comprises the steps of providing a valved conduit in accordance with embodiments herein and surgically implanting the valved conduit. The procedure may further comprise identifying an inflow portion (or end) and outflow portion (or end) of the conduit; accessing the intended position with respect to anatomy; optionally trimming the inflow portion (or end) and outflow portion (or end) of the conduit to the appropriate length for implantation; optionally outwardly tapering the inflow end or optionally everting and rolling the inflow portion toward the leaflet structure to define a sewing cuff; sectioning the ascending aorta; coupling the inflow portion of the valved conduit to the left ventricle adjacent to or in the place of an excised aortic valve; and coupling the outflow portion of the valved conduit to the sectioned ascending aorta. The procedure may further comprise coupling coronary arteries to the outflow portion of the conduit; and establishing a flow path from the conduit lumen to the coronary arteries.

In certain embodiments, the conduits discussed herein include an expanded fluoropolymer material made from porous ePTFE membrane.

The expandable fluoropolymer, used to form the expanded fluoropolymer material described, can comprise PTFE homopolymer. In alternative embodiments, blends of PTFE, expandable modified PTFE and/or expanded copolymers of PTFE can be used.

The expanded fluoropolymer membrane can comprise any suitable microstructure, such as pores, for achieving the desired leaflet performance. Other biocompatible polymers which can be suitable for use in leaflet include but are not limited to the groups of urethanes, silicones (organopolysiloxanes), copolymers of silicon-urethane, styrene/isobutylene copolymers, polyisobutylene, polyethylene-copoly( vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers and copolymers or mixtures of each of the foregoing.

In various examples, any of the leaflet constructs described herein (e.g., leaflet construct) may be formed of a biocompatible, synthetic material (e.g., including ePTFE and ePTFE composites, or other materials as desired). Other biocompatible polymers which can be suitable for use in synthetic leaflets include but are not limited to the groups of urethanes, silicones (organopolysiloxanes), copolymers of silicon-urethane, styrene/isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers and copolymers or mixtures of each of the foregoing.

In other examples, such leaflet construct is formed of a natural material, such as repurposed tissue, including bovine tissue, porcine tissue, or the like.

As used herein, the term "elastomer" refers to a polymer or a mixture of polymers that has the ability to be stretched to at least <NUM> times its original length and to retract rapidly to approximately its original length when released. The term "elastomeric material" refers to a polymer or a mixture of polymers that displays stretch and recovery properties similar to an elastomer, although not necessarily to the same degree of stretch and/or recovery. The term "non-elastomeric material" refers to a polymer or a mixture of polymers that displays stretch and recovery properties not similar to either an elastomer or elastomeric material, that is, considered not an elastomer or elastomeric material.

In accordance with some embodiments herein, the leaflet construct comprises a composite material having at least one porous synthetic polymer membrane layer having a plurality of pores and/or spaces and an elastomer and/or an elastomeric material and/or a non-elastomeric material filling the pores and/or spaces of the at least one synthetic polymer membrane layer. In accordance with other examples, the leaflet construct further comprises a layer of an elastomer and/or an elastomeric material and/or a non-elastomeric material on the composite material. In accordance with some examples, the composite material comprises porous synthetic polymer membrane by weight in a range of about <NUM>% to <NUM>%.

An example of a porous synthetic polymer membrane includes expanded fluoropolymer membrane having a node and fibril structure defining the pores and/or spaces. In some examples, the expanded fluoropolymer membrane is expanded polytetrafluoroethylene (ePTFE) membrane. Another example of porous synthetic polymer membrane includes microporous polyethylene membrane.

Examples of an elastomer and/or an elastomeric material and/or a non-elastomeric material include, but are not limited to, copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether (TFE/PMVE copolymer), (per)fluoroalkylvinylethers (PAVE), urethanes, silicones (organopolysiloxanes), copolymers of silicon-urethane, styrene/isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers and copolymers or mixtures of each of the foregoing. In some examples, the TFE/PMVE copolymer is an elastomer comprising essentially of between and including <NUM> and <NUM> weight percent tetrafluoroethylene and respectively between and including <NUM> and <NUM> weight percent perfluoromethyl vinyl ether. In some examples, the TFE/PMVE copolymer is an elastomeric material comprising essentially of between and including <NUM> and <NUM> weight percent tetrafluoroethylene and respectively between and including <NUM> and <NUM> weight percent perfluoromethyl vinyl ether. In some examples, the TFE/PMVE copolymer is a nonelastomeric material comprising essentially of between and including <NUM> and <NUM> weight percent tetrafluoroethylene and respectively between and including <NUM> and <NUM> weight percent perfluoromethyl vinyl ether. The TFE and PMVE components of the TFE-PMVE copolymer are presented in wt%. For reference, the wt% of PMVE of <NUM>, <NUM>-<NUM>, and <NUM>-<NUM> corresponds to a mol% of <NUM>, <NUM>-<NUM>, and <NUM>-<NUM>, respectively.

In some examples, the TFE-PMVE copolymer exhibits elastomer, elastomeric, and/or non-elastomeric properties.

In some examples, the composite material further comprises a layer or coating of TFE-PMVE copolymer comprising from <NUM> to <NUM> weight percent tetrafluoroethylene and respectively from <NUM> to <NUM> weight percent perfluoromethyl vinyl ether.

In some examples, the leaflet construct is an expanded polytetrafluoroethylene (ePTFE) membrane having been imbibed with TFE-PMVE copolymer comprising from <NUM> to <NUM> weight percent tetrafluoroethylene and respectively from <NUM> to <NUM> weight percent perfluoromethyl vinyl ether, the leaflet construct further including a coating of TFE-PMVE copolymer comprising from <NUM> to <NUM> weight percent tetrafluoroethylene and respectively <NUM> to <NUM> weight percent perfluoromethyl vinyl ether on the blood-contacting surfaces.

As discussed above, the elastomer and/or an elastomeric material and/or a non-elastomeric material may be combined with the expanded fluoropolymer membrane such that the elastomer and/or the elastomeric material and/or the non-elastomeric material occupies substantially all of the void space or pores within the expanded fluoropolymer membrane.

In accordance with an embodiment, the composite material can include an expanded fluoropolymer material made from porous ePTFE membrane.

The expanded fluoropolymer membrane, used to form some of the composites described, can comprise PTFE homopolymer. In alternative embodiments, blends of PTFE, expandable modified PTFE and/or expanded copolymers of PTFE can be used.

Claim 1:
A prosthetic cardiac valved conduit (<NUM>) comprising:
a conduit (<NUM>) having an interior surface and an exterior surface; and
a frame element (<NUM>) arranged within the conduit (<NUM>) and having commissure posts (<NUM>, <NUM>, <NUM>) arranged about the frame element (<NUM>), the frame element (<NUM>) having a first diameter in a first configuration and configured to support a valve structure (<NUM>) having leaflets (<NUM>) configured to open to permit flow and close to occlude a conduit lumen and prevent flow in response to differential fluid pressure and to expand to a second, larger diameter in a second configuration in response to a force applied to an interior portion of the frame element (<NUM>);
one or more expansion elements (<NUM>; <NUM>, <NUM>, <NUM>, <NUM>) arranged between or adjacent to the commissure posts (<NUM>, <NUM>, <NUM>) and configured to spread apart to radially expand the frame element (<NUM>) in transitioning between the first configuration and the second configuration; and
wherein the frame element (<NUM>) includes a first circular rim (<NUM>) and a second circular rim (<NUM>) connected by the commissure posts (<NUM>, <NUM>, <NUM>), and the one or more expansion elements (<NUM>; <NUM>, <NUM>, <NUM>, <NUM>) form portions of at least one of the first circular rim (<NUM>) and the second circular rim (<NUM>).