Patent Description:
A human heart includes four heart valves that determine the pathway of blood flow through the heart: the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve. The mitral and tricuspid valves are atrioventricular valves, which are between the atria and the ventricles, while the aortic and pulmonary valves are semitunar valves, which are in the arteries leaving the heart. Ideally, native leaflets of a heart valve move apart from each other when the valve is in an open position, and meet or "coapt" when the valve is in a closed position. Problems that may develop with valves include stenosis, in which a valve does not open properly, and/or insufficiency or regurgitation in which a valve does not close properly. Stenosis and insufficiency may occur concomitantly in the same valve. The effects of valvular dysfunction vary, with regurgitation or backflow typically having relatively severe physiological consequences to the patient.

Recently, flexible prosthetic valves supported by stent or scaffold structures that can be delivered percutaneously using a catheter-based delivery system have been developed for heart and venous valve replacement. These prosthetic valves may include either self-expanding or balloon-expandable stent structures with valve leaflets attached to the interior of the stent structure. The prosthetic valve can be reduced in diameter, by compressing onto a balloon catheter or by being contained within a sheath component of a delivery catheter, and advanced through the venous or arterial vasculature. Once the prosthetic valve is positioned at the treatment site, for instance within an incompetent native valve, the stent structure may be expanded to hold the prosthetic valve firmly in place. One example of a stented prosthetic valve is disclosed in <CIT> entitled "Percutaneous Placement Valve Stent". Another example of a stented prosthetic valve for a percutaneous pulmonary valve replacement procedure is described in <CIT> and <CIT>.

Although transcatheter delivery methods have provided safer and less invasive methods for replacing a defective native heart valve, complications may arise including vessel trauma due to percutaneous delivery within highly curved anatomy and/or due to a large delivery profile of the prosthesis, inaccurate placement of the valve prosthesis, conduction disturbances, coronary artery obstruction, and/or undesirable paravalvular leakage and/or regurgitation at the implantation site. Embodiments hereof are directed to a valve prosthesis system having an improved configuration to address one or more of the afore-mentioned complications. <CIT> describes an apparatus for securing heart valve repair or replacement prostheses in or near the heart. <CIT> describes a heart valve prosthesis and a method of implanting the prosthesis.

The invention relates to a valve prosthesis system including a docking component and a prosthetic valve component and is defined by the appended claims. The prosthetic valve component is configured to be delivered separately from the docking component. The docking component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The docking component includes a tubular body formed from an impermeable material, the tubular body having opposing first and second end portions and an intermediate portion extending between the first and second end portions, a first annular scaffold attached to the tubular body along the first end portion thereof, and a second annular scaffold attached to the tubular body along the second end portion thereof. The first and second annular scaffolds are independent from each other. The intermediate portion of the tubular body is unsupported such that neither of the first or second annular scaffolds surrounds the intermediate portion of the tubular body. The prosthetic valve component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the intermediate portion of the docking component.

Embodiments hereof also relate to a valve prosthesis system includes an exterior docking component and an interior dockable component. The exterior docking component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve. The exterior docking component includes a tubular skirt, a first annular scaffold attached to a first end of the tubular skirt, and a second annular scaffold attached to a second end of the tubular skirt. The first and second annular scaffolds are independent from each other and an intermediate portion of the tubular skirt that longitudinally extends between the first and second annular scaffolds is unsupported such that neither of the first or second annular scaffolds surrounds the intermediate portion of the tubular skirt. The interior dockable component has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the skirt of the exterior docking component. The interior dockable component includes a scaffold and at least two valve leaflets disposed within and secured to the scaffold. The interior dockable component is configured to be delivered separately from the exterior docking component and the interior dockable component is configured to couple to the intermediate portion of the tubular skirt of the exterior docking component in situ such that the tubular skirt is radially disposed around and contacts the interior dockable component.

Examples useful to understand the invention hereof also relate to method of deploying a valve prosthesis system in situ. A docking component is percutaneously delivered within a vasculature to a native heart valve. The docking component is in a compressed configuration during delivery. The docking component includes a tubular body formed from an impermeable material, a first annular scaffold attached to the tubular body along a first end portion thereof, and a second annular scaffold attached to the tubular body along a second end portion thereof, the first and second annular scaffolds being independent from each other and an intermediate portion of the tubular body being unsupported such that neither of the first or second annular scaffolds surround the intermediate portion of the tubular body. The docking component is deployed to an expanded configuration within the native heart valve. A prosthetic valve component is percutaneously delivered within a vasculature to the native heart valve. The prosthetic valve component is in a compressed configuration during delivery. The prosthetic valve component is deployed to an expanded configuration within the intermediate portion of the docking component. Deployment of the prosthetic valve component occurs after deployment of the docking component.

Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. Unless otherwise indicated, the terms "distal" and "proximal" are used in the following description with respect to a position or direction relative to the treating clinician. "Distal" and "distally" are positions distant from or in a direction away from the clinician, and "proximal" and "proximally" are positions near or in a direction toward the clinician. In addition, the term "self-expanding" is used in the following description with reference to one or more support structures of the valve prosthesis systems hereof and is intended to convey that the structures are shaped or formed from a material that can be provided with a mechanical memory to return the structure from a compressed or constricted delivery configuration to an expanded deployed configuration. Non-exhaustive exemplary self-expanding materials include a pseudo-elastic metal such as a nickel titanium alloy or nitinol, a spring-tempered steel, various polymers, or a so-called super alloy, which may have a base metal of nickel, cobalt, chromium, or other metal. Mechanical memory may be imparted to a wire or scaffold structure by thermal treatment to achieve a spring temper in stainless steel, for example, or to set a shape memory in a susceptible metal alloy, such as nitinol. Various polymers that can be made to have shape memory characteristics may also be suitable for use in embodiments hereof to include polymers such as polynorborene, trans-polyisoprene, styrene-butadiene, and polyurethane. As well poly L-D lactic copolymer, oligo caprylactone copolymer and polycyclooctene can be used separately or in conjunction with other shape memory polymers.

Although the description of the invention is in the context of replacement of aortic valves, the prosthetic valves of the invention can also be used in other areas of the body, such as for replacement of a native mitral valve, for replacement of a native pulmonic valve, for replacement of a native tricuspid valve, for use as a venous valve, or for replacement of a failed previously-implanted prosthesis,.

Embodiments hereof relate to a two-component valve prosthesis system that includes a docking component and a prosthetic valve component. The prosthetic valve component is configured to be delivered and/or deployed separately from the docking component. The docking component includes two anchoring scaffold or stent-like structures at inflow and outflow ends thereof that are separated and connected by a tubular skirt. An unsupported or scaffold-free intermediate portion of the tubular skirt extends between the anchoring scaffolds of the docking component. In situ, the prosthetic valve component is deployed against the unsupported intermediate portion of the tubular skirt. The scaffold-free intermediate portion of the tubular skirt thus functions as a landing zone for deployment of the prosthetic valve component and also functions as a continuous circumferential seal around the deployed prosthetic valve component to block or prevent blood flow around the outer perimeter thereof thereby minimizing and/or eliminating any paravalvular leakage at the implantation site.

More particularly, <FIG> illustrate a valve prosthesis system <NUM> according to an embodiment hereof. Valve prosthesis system <NUM> includes a docking component <NUM> and a prosthetic valve component <NUM>. <FIG> is an exploded side view in which docking component <NUM> and prosthetic valve component <NUM> are each shown separately in an expanded configuration, while <FIG> is a side view in which prosthetic valve component <NUM> is disposed within docking component <NUM>. Docking component <NUM> is also referred to herein as an exterior docking component and prosthetic valve component <NUM> is also referred to herein as an interior dockable component. Docking component <NUM> is configured to fit and conform to the anatomy when expanded or deployed in situ in order to prevent paravalvular leakage (PVL) and prosthetic valve component <NUM> is implanted into docking component <NUM>. As such, docking component <NUM> may be designed, sized, or otherwise configured to fit and conform to native heart anatomy at any desired valve location, while prosthetic valve component <NUM> has a universal or common optimized design that fits into any or all docking component(s). Accordingly, valve prosthesis system <NUM> is designed so that a single or universal prosthetic valve component <NUM> may be deployed at a multitude of heart valve sites (i.e., aortic, mitral, tricuspid, pulmonic).

Docking component <NUM> has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve. <FIG> is a side view of docking component <NUM> in the expanded configuration, the docking component being removed from valve prosthesis system <NUM> for illustrative purposes only. <FIG> is a cross-sectional view taken along line A-A of <FIG>. Docking component <NUM> includes a tubular body or skirt <NUM>, a first annular scaffold 106A, and a second annular scaffold 106B. When configured as a replacement for an aortic valve, second annular scaffold 106B functions as an inflow end of valve prosthesis system <NUM> and anchors within the aortic annulus, while first annular scaffold 106A functions as an outflow end of valve prosthesis system <NUM> and anchors within the aortic annulus. "Inflow" and "outflow" refers to the direction of blood flow relative to the valve prosthesis system once it is implanted in a patient.

Tubular skirt <NUM> is constructed from an impermeable biocompatible material such as but not limited to a polymer material, a fabric material, or a pericardium that is shaped as a tubular body to define lumen <NUM> there-through as shown in the cross-sectional view of <FIG>. Lumen <NUM> is also illustrated in <FIG>, which is a perspective view of tubular skirt <NUM> removed from docking component <NUM> for illustrative purposes only. Tubular skirt <NUM> has a first end <NUM> and a second or opposing end <NUM>. Suitable materials include but are not limited to a low-porosity fabric, such as polyester, DACRON®, or polytetrafluoroethylene (PTFE). Tubular skirt <NUM> is thin-walled so that valve prosthesis system <NUM> may be compressed into a small diameter, yet is capable of acting as a strong, leak-resistant fluid conduit when expanded to a cylindrical tubular form. In one embodiment, tubular skirt <NUM> may be a knit or woven polyester, such as a polyester or PTFE knit, which can be utilized when it is desired to provide a medium for tissue ingrowth and the ability for the fabric to stretch to conform to a curved surface. Polyester velour fabrics may alternatively be used, such as when it is desired to provide a medium for tissue ingrowth on one side and a smooth surface on the other side. These and other appropriate cardiovascular fabrics are commercially available from Bard Peripheral Vascular, Inc. of Tempe, Ariz. , for example. In another embodiment hereof, tubular skirt <NUM> may be made of pericardial material. Natural tissue for tubular skirt <NUM> may be obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue, such as pericardial patches, bypass grafts, blood vessels, intestinal submucosal tissue, umbilical tissue and the like from humans or animals.

First annular scaffold 106A is attached to first end <NUM> of tubular skirt <NUM>, and second annular scaffold 106B is attached to second or opposing end <NUM> of tubular skirt <NUM>. As shown in <FIG>, tubular skirt <NUM> includes a first end portion <NUM>, a second or opposing end portion <NUM>, and an intermediate portion <NUM> that extends between first and second end portions <NUM>, <NUM>. Intermediate portion <NUM> of tubular skirt <NUM> is unsupported or scaffold-free such that neither of first or second annular scaffolds 106A, 106B surround the intermediate portion of the tubular skirt as will be described in more detail herein. First annular scaffold 106A is attached to tubular skirt <NUM> along first end portion <NUM>, and second annular scaffold 106B is attached to the tubular body along second end portion <NUM> thereof. Intermediate portion <NUM> of tubular skirt <NUM> longitudinally extends between first and second annular scaffolds 106A, 106B. The length of each portion, i.e., first end portion <NUM>, intermediate portion <NUM>, and second end portion <NUM>, may vary depending on the desired application, on the desired native valve location for the prosthesis, and/or on the size of the patient.

First and second annular scaffolds 106A, 106B are stent-like structures that are independent of each other. "Independent" as used herein means that first and second annular scaffolds are separate from each other and are not directly attached to each other. However, first and second annular scaffolds 106A, 106B are connected or indirectly linked to each other via intermediate portion <NUM> of tubular skirt <NUM> that extends therebetween as described above.

First and second annular scaffolds 106A, 106B are both self-expanding components that return to an expanded deployed state from a compressed or constricted delivery state. First and second annular scaffolds 106A, 106B are both sized to anchor valve prosthesis system <NUM> against native valve tissue when the prosthesis is in the expanded configuration. In this embodiment, first and second annular scaffolds 106A, 106B each include a sinusoidal patterned ring as shown in the perspective view of <FIG>. However, it will be understood by one of ordinary skill in the art that the illustrated configurations of first and second annular scaffolds 106A, 106B are exemplary and first and second annular scaffolds 106A, 106B may have alternative patterns or configurations. For example, in another embodiment shown in <FIG>, first and second annular scaffolds 606A, 606B are tubular components having diamond-shaped openings <NUM> which may be formed by a laser-cut manufacturing method and/or another conventional stent/scaffold forming method as would be understood by one of ordinary skill in the art. In another embodiment hereof (not shown), the first and second annular scaffolds may each have distinct configurations and/or include an additional element such as a flared end portion that aids in fixing or anchoring docking component <NUM> within native valve anatomy. Further, in another embodiment hereof, the first and second annular scaffolds are configured to be balloon-expandable rather than self-expanding and thus would not be required to be formed from a shape memory material.

First and second annular scaffolds 106A, 106B are coupled to first and second end portions <NUM>, <NUM>, respectively, of tubular skirt <NUM> in order to bias and/or anchor the first and second end portions of tubular skirt <NUM> into apposition with an interior wall of a body lumen (not shown). First and second end portions <NUM>, <NUM>, respectively, of tubular skirt <NUM> are thus supported by first and second annular scaffolds 106A, 106B. As used herein, "supported" means that the graft material of first and second end portions <NUM>, <NUM> of tubular skirt <NUM> has radial support along its length and circumference. In particular, first annular scaffold 106A surrounds and overlaps with first end portion <NUM> of tubular skirt <NUM> and second annular scaffold 106B surrounds and overlaps with second end portion <NUM> of tubular fabric body. First and second annular scaffolds 106A, 106B may longitudinally extend up to or beyond first and second ends <NUM>, <NUM>, respectively, of tubular skirt <NUM>. <FIG> illustrates an embodiment in which both first and second annular scaffolds 106A, 106B longitudinally extend beyond first and second ends <NUM>, <NUM>, respectively, of tubular skirt <NUM>. Alternatively, in another embodiment (now shown), first annular scaffold 106A may longitudinally extend up to but not beyond first end <NUM> of tubular skirt <NUM> and/or second annular scaffold 106B may longitudinally extend up to but not beyond second end <NUM> of tubular skirt <NUM>. First and second annular scaffolds 106A, 106B may be attached or mechanically coupled to first and second end portions <NUM>, <NUM>, respectively, of tubular skirt <NUM> by various means, such as, for example, by stitching or suturing onto either an inner surface or an outer surface of tubular skirt <NUM>.

Intermediate portion <NUM> of tubular skirt <NUM> is scaffold-free and unsupported. "Unsupported" as used herein means that the material of intermediate portion <NUM> of tubular skirt <NUM> has no radial support along its length or circumference and is not surrounded by any tubular or annular scaffold or stent-like structure. Stated another way, first and second annular scaffolds 106A, 106B do not surround and do not overlap intermediate portion <NUM> of tubular skirt <NUM>. Intermediate portion <NUM> of tubular skirt <NUM> provides a landing site or zone for prosthetic valve component <NUM>, which is delivered separately from docking component <NUM> as described in more detail herein.

Prosthetic valve component <NUM> has a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the intermediate portion of the docking component. Prosthetic valve component <NUM> includes a scaffold <NUM> formed from a self-expanding material and at least two valve leaflets <NUM> disposed within and secured to scaffold <NUM>. Prosthetic valve component <NUM> is capable of blocking flow in one direction to regulate flow there-through via valve leaflets <NUM> that may form a bicuspid or tricuspid replacement valve. <FIG> is an end view of prosthetic valve component <NUM> taken from the second or outflow end thereof, the prosthetic valve component being removed from valve prosthesis system <NUM> for illustrative purposes only. <FIG> illustrates an exemplary tricuspid valve having three leaflets <NUM>, although a bicuspid leaflet configuration may alternatively be used in embodiments hereof. More particularly, if valve prosthesis system <NUM> is configured for placement within a native valve having three leaflets such as the aortic, tricuspid, or pulmonary valves, valve prosthesis system <NUM> includes three valve leaflets <NUM> although the valve prosthesis is not required to have the same number of leaflets as the native valve. If valve prosthesis system <NUM> is configured for placement within a native valve having two leaflets such as the mitral valve, valve prosthesis system <NUM> includes two or three valve leaflets <NUM>. Valve leaflets <NUM> are sutured or otherwise securely and sealingly attached (i.e., via suitable biocompatible adhesive) to the inner surface of scaffold <NUM>. Adjoining pairs of leaflets are attached to one another at their lateral ends to form commissures <NUM>, with free edges <NUM> of the leaflets forming coaptation edges that meet in area of coaptation <NUM>.

Leaflets <NUM> may be made of pericardial material; however, the leaflets may instead be made of another material. Natural tissue for replacement valve leaflets may be obtained from, for example, heart valves, aortic roots, aortic walls, aortic leaflets, pericardial tissue, such as pericardial patches, bypass grafts, blood vessels, intestinal submucosal tissue, umbilical tissue and the like from humans or animals. Synthetic materials suitable for use as leaflets <NUM> include DACRON® commercially available from Invista North America S. of Wilmington, DE, other cloth materials, nylon blends, and polymeric materials. One polymeric material from which the leaflets can be made is an ultra-high molecular weight polyethylene material commercially available under the trade designation DYNEEMA from Royal DSM of the Netherlands. With certain leaflet materials, it may be desirable to coat one or both sides of the leaflet with a material that will prevent or minimize overgrowth. It is further desirable that the leaflet material is durable and not subject to stretching, deforming, or fatigue.

<FIG> is a side view of scaffold <NUM> laid flat for illustrative purposes only. In this embodiment, scaffold <NUM> is an annular ring that defines three posts 130A, 130B, 130C aligned with commissures <NUM> of leaflets <NUM>. Scaffold <NUM> is formed from a strand or wire-like element formed into an annular ring. However, it will be understood by one of ordinary skill in the art that the illustrated configurations of scaffold <NUM> is exemplary and scaffold <NUM> may have an alternative pattern or configuration. For example, in another embodiment shown in <FIG>, a prosthetic valve component <NUM> includes a plurality of leaflets <NUM> disposed within a tubular scaffold <NUM> formed from a self-expanding material, the tubular scaffold defining diamond-shaped openings <NUM> which may be formed by a laser-cut manufacturing method and/or another conventional stent/scaffold forming method as would be understood by one of ordinary skill in the art. Further, in another embodiment hereof, the scaffold of the prosthetic valve component is configured to be balloon-expandable rather than self-expanding and thus would not be required to be formed from a shape memory material.

Prosthetic valve component <NUM> is configured to be delivered separately from docking component <NUM> and is configured to couple to intermediate portion <NUM> of tubular skirt <NUM> of docking component <NUM> in situ such that the tubular skirt is radially disposed around and contacts scaffold <NUM> of prosthetic valve component <NUM>. As previously stated, intermediate portion <NUM> of tubular skirt <NUM> thus serves as a landing or target zone for deployment of prosthetic valve component <NUM>. In addition, when tubular skirt <NUM> is radially disposed around prosthetic valve component <NUM> after deployment of the prosthetic valve component, tubular skirt <NUM> prevents paravalvular leakage (PVL) by functioning to occlude or fill gaps between the perimeter of prosthetic valve component <NUM> and the native valve annulus, thereby reducing, minimizing, or eliminating leaks there-between. The native valve annulus may include surface irregularities on the inner surface thereof, and as a result one or more gaps or cavities/crevices may be present or may form between the perimeter of the valve prosthesis and the native valve annulus. For example, calcium deposits may be present on the native valve leaflets (e.g., stenotic valve leaflets) and/or shape differences may be present between the native heart annulus and the valve prosthesis. More particularly, in some cases native annuli are not perfectly rounded and have indentations corresponding to the commissural points of the native valve leaflets. As a result, a prosthesis having an approximately circular shape does not provide an exact fit in a native valve. These surface irregularities, whatever their underlying cause, can make it difficult for conventional prosthetic valves to form a blood tight seal between the prosthetic valve and the inner surface of the valve annulus, causing undesirable paravalvular leakage and/or regurgitation at the implantation site. In embodiments hereof, tubular skirt <NUM> functions to block any retrograde flow within the native valve, thereby preventing undesired regurgitation and preventing blood stagnation in and around the native valve sinuses. In addition, tubular skirt <NUM> fills any/all gaps or cavities/crevices between the outer surface of scaffold <NUM> and native valve tissue such that blood flow through the target gap or cavity is occluded or blocked, or stated another way blood is not permitted to flow there-through. Tubular skirt <NUM> functions as a continuous circumferential seal around prosthetic valve component <NUM> to block or prevent blood flow around the outer perimeter thereof, thereby minimizing and/or eliminating any paravalvular leakage at the implantation site.

In an embodiment hereof, prosthetic valve component <NUM> is approximately <NUM> in longitudinal length and a diameter (in the expanded configuration) will be sized to fit the native patient anatomy and to provide an interference fit with intermediate portion <NUM> of tubular skirt <NUM> of docking component <NUM>. Intermediate portion <NUM> of tubular skirt <NUM> of docking component <NUM> has a longitudinal length at least as long as prosthetic valve component <NUM> to allow successful docking.

As best shown in <FIG>, scaffold <NUM> includes a plurality of barbs or hooks <NUM> on an outside surface thereof to aid in fixation thereof to docking component <NUM>. Barbs <NUM> are configured to catch, grab, or otherwise embed into intermediate portion <NUM> of tubular skirt <NUM> of docking component <NUM> in order to couple prosthetic valve component <NUM> to docking component <NUM> in situ. Barbs <NUM> radially extend away from scaffold <NUM> and each barb includes a free end that is sharp enough to engage with intermediate portion <NUM> of tubular skirt <NUM>. Barbs <NUM> extend at an acute angle relative to the outer surface of scaffold <NUM> so that they extend at least slightly outward relative to the outer surface of the scaffold. Barbs <NUM> may be coupled to scaffold <NUM> or integrally formed therewith. As explained in more detail herein, during implantation, prosthetic valve component <NUM> is partially deployed into docking component <NUM> and then rotated in order to embed barbs <NUM> into intermediate portion <NUM> of tubular skirt <NUM>. After barbs <NUM> are embedded as desired, prosthetic valve component <NUM> is fully deployed into docking component <NUM>.

<FIG> illustrate a valve prosthesis system <NUM> according to another embodiment hereof in which a docking component <NUM> and a prosthetic valve component <NUM> thereof couple together via mating configurations or profiles. <FIG> is an exploded side view of valve prosthesis system <NUM>, while <FIG> is a side view of prosthetic valve component <NUM> being disposed or deployed within docking component <NUM>. Docking component <NUM> includes a tubular scaffold <NUM> having diamond-shaped openings <NUM> which may be formed by a laser-cut manufacturing method and/or another conventional stent/scaffold forming method as would be understood by one of ordinary skill in the art. Tubular scaffold <NUM> includes a proximal or end portion <NUM>, a distal or end portion <NUM>, and an intermediate waist portion <NUM> disposed between proximal and distal portions <NUM>, <NUM>. Intermediate waist portion <NUM> has a diameter that is less than the diameters of each of proximal and distal portions <NUM>, <NUM>. A tubular skirt <NUM> is disposed within and secured to the inner surface of intermediate waist portion <NUM> of tubular scaffold <NUM>.

Prosthetic valve component <NUM> includes a plurality of leaflets <NUM> disposed within and secured to a tubular scaffold <NUM> formed from a self-expanding material, the tubular scaffold defining diamond-shaped openings <NUM> which may be formed by a laser-cut manufacturing method and/or another conventional stent/scaffold forming method as would be understood by one of ordinary skill in the art. Tubular scaffold <NUM> includes a proximal end 1136A, a distal end 1136B, and a body <NUM> that is disposed or extends between proximal and distal ends 1136A, 1136B. Proximal and distal ends 1136A, 1136B are flared such that body <NUM> has a diameter that is less than the diameters of each of proximal and distal ends 1136A, 1136B.

Prosthetic valve component <NUM> is configured to be delivered separately from docking component <NUM> and is configured to couple to intermediate waist portion <NUM> of docking component <NUM> in situ such that tubular skirt <NUM> is radially disposed around and contacts body <NUM> of prosthetic valve component <NUM> as shown in <FIG>. Intermediate waist portion <NUM> of tubular scaffold <NUM> of docking component <NUM> is configured to be longitudinally disposed between flared proximal and distal ends 1136A, 1136B of tubular scaffold <NUM> of prosthetic valve component <NUM> in order to couple the docking component and prosthetic valve component together in situ. Flared proximal and distal ends 1136A, 1136B of tubular scaffold <NUM> provide interference with respect to intermediate waist portion <NUM> of docking component <NUM> and secure prosthetic valve component <NUM> in place and prevent migrations due to anatomical and blood flow loads. Stated another way, an outer profile of prosthetic valve component <NUM> is configured to mate with an inner profile of docking component <NUM> in order to couple to the docking component and prosthetic valve component together in situ such that tubular skirt <NUM> is radially disposed or sandwiched there-between. In this embodiment, tubular skirt <NUM> serves as a landing or target zone for deployment of prosthetic valve component <NUM>. In addition, when tubular skirt <NUM> is radially disposed around prosthetic valve component <NUM> after deployment of the prosthetic valve component, tubular skirt <NUM> prevents paravalvular leakage (PVL) by functioning to occlude or fill gaps between the perimeter of prosthetic valve component <NUM> and the native valve annulus, thereby reducing, minimizing, or eliminating leaks there-between.

<FIG> illustrate an exemplary method of implanting the above-described valve prosthesis system <NUM> within a native valve according to an embodiment hereof. As will be understood by one of ordinary skill in the art, docking component <NUM> of valve prosthesis system <NUM> in a radially compressed configuration is loaded onto a distal portion of a catheter <NUM>. The radially compressed configuration of docking component <NUM> of valve prosthesis system <NUM> is suitable for percutaneous delivery within a vasculature. Catheter <NUM> is configured for percutaneous transcatheter valve replacement, and may be one of, but is not limited to, the delivery systems described in <CIT>, <CIT>, <CIT>, <CIT>, and <CIT> As shown in <FIG>, in accordance with techniques known in the field of interventional cardiology and/or interventional radiology, catheter <NUM> having distal end <NUM> is transluminally advanced in a retrograde approach through the vasculature to the treatment site, which in this instance is a target diseased native aortic valve AV that extends between a patient's left ventricle LV and a patient's aorta A. The coronary arteries CA are also shown on the sectional view of <FIG>. Delivery of catheter <NUM> to the native aortic valve AV may be accomplished via a percutaneous transfemoral approach or may be positioned within the desired area of the heart via different delivery methods known in the art for accessing heart valves. During delivery, docking component <NUM> of valve prosthesis system <NUM> remains compressed within an outer sheath <NUM> of catheter <NUM>. Catheter <NUM> is advanced until distal end <NUM> is distal to the native aortic valve AV and disposed within the left ventricle LV as shown in <FIG>. In an embodiment, catheter <NUM> is advanced approximately <NUM> into the left ventricle LV.

Once catheter <NUM> is positioned as desired, outer sheath <NUM> of catheter <NUM> is retracted to release docking component <NUM> of valve prosthesis system <NUM>. Docking component <NUM> is then deployed to its expanded configuration within the native heart valve as shown in <FIG>. When deploying docking component <NUM>, it may be desirable to apply tension to intermediate portion <NUM> of tubular skirt <NUM> of docking component <NUM>. More particularly, outer sheath <NUM> of catheter <NUM> may be retracted to expose only second annular scaffold 106B and at least a portion of intermediate portion <NUM> of tubular skirt <NUM> of docking component <NUM>. Once released from outer sheath <NUM>, self-expanding second annular scaffold 106B returns to its expanded or deployed configuration. Upon release from outer sheath <NUM>, intermediate portion <NUM> of tubular skirt <NUM> of docking component <NUM> may include slack in which the material thereof is baggy, saggy, or otherwise loose. Slack may be present since intermediate portion <NUM> is not supported by any tubular or circumferential scaffold elements. At this point in the procedure, first annular scaffold 106A is still restrained within outer sheath <NUM> but second annular scaffold 106B is deployed against the annulus of the native aortic valve AV. The entire catheter <NUM> having docking component <NUM> mounted thereon may be pulled or proximally retracted by the user, or the catheter may include a separate mechanism (not shown) such that docking component <NUM> may be separately or independently pulled or proximally retracted without retracting the entire catheter <NUM>. With second annular scaffold 106B seated in apposition with the annulus of native aortic valve AV, catheter <NUM> is proximally retracted in order to supply tension to intermediate portion <NUM> of tubular skirt <NUM>. Catheter <NUM> is pulled proximally until intermediate portion <NUM> of tubular skirt <NUM> is taut or stretched to a generally straight configuration and no slack is present along the length of intermediate portion <NUM>. During the step of applying tension to tubular skirt <NUM>, deployment of docking component <NUM> would preferably be monitored through imaging (e.g. fluoro, angio) to ensure that second annular scaffold 106B does not migrate but rather remains seated in apposition with the annulus of native aortic valve AV.

Once tension has been applied to tubular skirt <NUM> if desired, i.e., after intermediate portion <NUM> of tubular skirt <NUM> is taut, outer sheath <NUM> of catheter <NUM> is retracted to expose first annular scaffold 106A. Once released from outer sheath <NUM>, self-expanding first annular scaffold 106A returns to its expanded or deployed configuration and deploys against the annulus of native aortic valve AV, thereby anchoring valve prosthesis system <NUM> to the aortic wall. Both first and second annular scaffolds 106A, 106B are deployed against the annulus of native aortic valve AV such that tubular skirt <NUM> does not cover or extend over the sinus proximal to the annulus of native aortic valve AV. Catheter <NUM> is then removed and docking component <NUM> remains deployed within the native aortic valve AV. If the native aortic valve AV includes native valve leaflets (not shown in FIGS. <NUM>-<NUM>) and such leaflets have not been removed or excised, docking component <NUM> is deployed within the native valve leaflets of the patient's defective valve, retaining the native valve leaflets in a permanently open state.

After deployment of docking component <NUM>, prosthetic valve component <NUM> of valve prosthesis system <NUM> in a radially compressed configuration is loaded onto a distal portion of a catheter <NUM>. The radially compressed configuration of prosthetic valve component <NUM> of valve prosthesis system <NUM> is suitable for percutaneous delivery within a vasculature. Catheter <NUM> is configured for percutaneous transcatheter valve replacement, and may be one of, but is not limited to, the delivery systems described in <CIT>, <CIT>, <CIT>, <CIT>, and <CIT> As shown in <FIG>, in accordance with techniques known in the field of interventional cardiology and/or interventional radiology, catheter <NUM> having distal end <NUM> is transluminally advanced in a retrograde approach through the vasculature to the deployed docking component <NUM>. Delivery of catheter <NUM> to the native aortic valve AV may be accomplished via a percutaneous transfemoral approach or may be positioned within the desired area of the heart via different delivery methods known in the art for accessing heart valves. During delivery, prosthetic valve component <NUM> of valve prosthesis system <NUM> remains compressed within an outer sheath <NUM> of catheter <NUM>. Catheter <NUM> is advanced until distal end <NUM> is advanced through the deployed docking component <NUM> and is distal to the native aortic valve AV and disposed within the left ventricle LV as shown in <FIG>.

As previously described, intermediate portion <NUM> of tubular skirt <NUM> of the deployed docking component serves as a landing or target zone for prosthetic valve component <NUM>. Once catheter <NUM> is positioned as desired, i.e., with prosthetic valve component <NUM> adjacent to intermediate portion <NUM> of tubular skirt <NUM> of the deployed docking component, outer sheath <NUM> of catheter <NUM> is retracted to release prosthetic valve component <NUM> of valve prosthesis system <NUM>. Prosthetic valve component <NUM> is then deployed to its expanded configuration within intermediate portion <NUM> of tubular skirt <NUM> of the deployed docking component. Deployment of prosthetic valve component <NUM> occurs after deployment of docking component <NUM>. When deploying prosthetic valve component <NUM>, it may be desirable to embed barbs <NUM> (if present) into intermediate portion <NUM> of tubular skirt <NUM>. More particularly, the step of deploying prosthetic valve component <NUM> to the expanded configuration within intermediate portion <NUM> of the deployed docking component includes deploying prosthetic valve component <NUM> to a partially deployed configuration. When in the partially deployed configuration, catheter <NUM> and prosthetic valve component <NUM> mounted thereon are rotated as shown in <FIG> via directional arrow <NUM> in order to embed barbs <NUM> into intermediate portion <NUM> of the deployed docking component and thereby couple prosthetic valve component <NUM> to docking component <NUM> in situ.

In an embodiment depicted in <FIG>, prosthetic valve component <NUM> is deployed to a partially deployed configuration by restraining only a proximal end or portion of scaffold <NUM> within outer sheath <NUM> of catheter <NUM>. Stated another way, a distal end of portion of scaffold <NUM> is deployed to initiate contact with intermediate portion <NUM> of the deployed docking component while the proximal engagement of scaffold <NUM> with catheter <NUM> allows rotation to be applied at the proximal end of the catheter. In another embodiment hereof depicted in <FIG>, prosthetic valve component <NUM> may be fully deployed while a connection is maintained between catheter <NUM> and fully deployed prosthetic valve component <NUM> in order to transfer rotation of catheter <NUM> to fully deployed prosthetic valve component <NUM>. For example, rods <NUM> or similar structures may extend between catheter <NUM> and fully deployed prosthetic valve component <NUM> in order to connect the proximal end of prosthetic valve component <NUM> to catheter <NUM>. Rods <NUM> would be circumferentially stiff, thus allowing sufficient rotational force to be applied to engage barbs <NUM> with intermediate portion <NUM> of the deployed docking component. Rods <NUM> may be wider in the circumferential direction and thinner in the radial direction so as to flexible enough to be retracted and sheathed into catheter <NUM> after barbs <NUM> are embedded as desired. Rods <NUM> extend through outer sheath <NUM> of catheter <NUM> such that the proximal ends thereof (not shown) are coupled to a handle mechanism (not shown) of catheter <NUM> for control thereof. Rods <NUM> are disengaged from the proximal end of prosthetic valve component <NUM> following valve deployment. For example, in an embodiment, rods <NUM> may be disengaged from the proximal end of prosthetic valve component <NUM> following valve deployment by applying a twisting motion to catheter <NUM>. After prosthetic valve component <NUM> is secured to docking component <NUM> via embedded barbs <NUM>, additional twisting motion applied to rods <NUM> functions to break the joints or connections between the distal ends of rods <NUM> and the proximal end of prosthetic valve component <NUM>.

After prosthetic valve component <NUM> is coupled to docking component <NUM> via barbs <NUM>, outer sheath <NUM> of catheter <NUM> is further retracted to fully deploy and release prosthetic valve component <NUM> of valve prosthesis system <NUM>. Stated another way, prosthetic valve component <NUM> is deployed to its fully expanded or deployed configuration within intermediate portion <NUM> of the deployed docking component as shown on <FIG>. After deployment, intermediate portion <NUM> of tubular skirt <NUM> serves to prevent paravalvular leakage (PVL) as described herein.

Although the above-described method of implanting valve prosthesis system <NUM> utilized two separate catheters, i.e., catheter <NUM> for delivering docking component <NUM> and catheter <NUM> for delivering prosthetic valve component <NUM>, in another embodiment hereof a single catheter may be utilized for implanting valve prosthesis system <NUM>. More particularly, a single catheter or delivery system may be modified to deliver valve prosthesis system <NUM> in a two-stage deployment in which docking component <NUM> and prosthetic valve component <NUM> are concurrently delivered or advanced to the target native valve or treatment site but docking component <NUM> is deployed prior to prosthetic valve component <NUM>. Stated another way, even if concurrently delivered on a single catheter or delivery system, prosthetic valve component <NUM> is configured to be deployed after or subsequent to deployment of docking component <NUM>.

Claim 1:
A valve prosthesis system comprising:
a docking component (<NUM>) having a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within a native heart valve, the docking component (<NUM>) comprising:
a tubular body formed from an impermeable material, the tubular body having opposing first and second end portions (<NUM>, <NUM>) and an intermediate portion (<NUM>) extending between the first and second end portions (<NUM>, <NUM>);
a first annular scaffold (106A) attached to the tubular body (<NUM>) along the first end portion (<NUM>) thereof;
a second annular scaffold (106B) attached to the tubular body (<NUM>) along the second end portion (<NUM>) thereof, wherein the first and second annular scaffolds (106A, 106B) are independent from each other, wherein the intermediate portion (<NUM>) of the tubular body (<NUM>) is unsupported such that neither of the first or second annular scaffolds (106A, 106B) surround or overlap the intermediate portion (<NUM>) of the tubular body (<NUM>); and
a prosthetic valve component (<NUM>) having a compressed configuration for percutaneous delivery within a vasculature and an expanded configuration for deployment within the intermediate portion (<NUM>) of the docking component (<NUM>), wherein the prosthetic valve component (<NUM>) is configured to be delivered separately from the docking component (<NUM>),
wherein the intermediate portion (<NUM>) has a longitudinal length at least as long as prosthetic valve component (<NUM>).