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 semilunar 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 an outer 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 Stene". 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 aforementioned complications.

<CIT> relates to devices and methods for controlling expandable prostheses during deployment. <CIT> relates to methods and devices for implanting cardiac valves. <CIT> relates to a heart valve anchor. <CIT> relates to an apparatus and methods for deployment of vascular prostheses.

The claimed invention is defined in independent claim <NUM>.

Embodiments hereof relate to a delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two wires being slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other.

In another embodiment hereof, a delivery system for transcatheter implantation of a heart valve prosthesis includes an outer sheath component defining a lumen therethrough, an elongate tube defining a lumen and having at least two wires longitudinally extending from a distal end thereof, a valve prosthesis having a self-expanding valve frame with a prosthetic valve component secured therein, and a self-expanding docking frame. The elongate tube and the at least two wires being slidably disposed within the lumen of the outer sheath component. The docking frame is disposed distal of the valve prosthesis when each is held in a compressed delivery configuration within a distal portion of the outer sheath component. In the compressed delivery configuration the at least two wires longitudinally extend along exterior portions of the valve frame and the docking frame and are woven through adjacent distal and proximal ends of the valve frame and the docking frame, respectively, to releasably couple them to each other.

Embodiments hereof that do not fall under the scope of the claimed subject-matter also relate to a method of implanting a valve prosthesis within a native valve. A delivery system is percutaneously advanced to the native valve. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube defining a lumen and having at least two wires longitudinally extending from a distal end thereof, and the elongate tube and the at least two wires being slidably disposed within the lumen of the outer sheath component. The delivery system further includes a valve prosthesis having a self-expanding valve frame with a prosthetic valve component secured therein and a self-expanding docking frame, the docking frame being disposed distal of the valve prosthesis and each frame being held in a compressed delivery configuration within a distal portion of the outer sheath component. The at least two wires longitudinally extend along exterior portions of the valve frame and the docking frame and are woven through adjacent distal and proximal ends of the valve frame and the docking frame, respectively, to releasably couple them to each other. The outer sheath component is proximally retracted to uncover the docking frame and thereby deploy the docking frame to an expanded configuration within the native valve. The outer sheath component is further proximally retracted to uncover the valve frame and thereby deploy the valve frame to an expanded configuration. The at least two wires is proximally retracted from the deployed docking frame to uncouple the deployed docking frame from the deployed valve frame. The deployed valve frame is recaptured into the outer sheath component. The recaptured valve frame is repositioned within the deployed docking frame. The outer sheath component is proximally retracted to uncover the recaptured valve frame and thereby deploy the valve frame to an expanded configuration within the deployed docking frame.

Specific embodiments of the present invention are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. Specific embodiments 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 stent structures of the prostheses 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 stainless steel, a pseudo-elastic metal such as a nickel titanium alloy or nitinol, 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 stent 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 poly cyclo-octine 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 delivery system for a valve prosthesis that utilizes flexible flat wires as both a coupling mechanism and a deployment mechanism. More particularly, the delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. As will be explained in more detail herein, a prosthetic valve component may be disposed in the first frame or in the second frame. The elongate tube is slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration, in which the first and second frames are disposed in series within a distal portion of the outer sheath component, the two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the flat wires from the first and second frames releases at least the first frame from the delivery system such that the flat wires serve as a coupling mechanism for the delivery system. In addition, when the outer sheath component is proximally retracted to uncover the first and second frames for deployment thereof, the flat wires slow the self-expansion of frames to control deployment of the valve prosthesis such that the flat wires also serve as a deployment mechanism for the delivery system.

More particularly, with reference to the side view of <FIG> and the cross-sectional view of <FIG> taken along line A-A of <FIG>, delivery system <NUM> includes an outer sheath component or cover <NUM>, an elongate tube <NUM> slidingly disposed within outer sheath component <NUM>, and an inner shaft <NUM> slidingly disposed within elongate tube <NUM>. Elongate tube <NUM> has at least two flat or ribbon wires <NUM> longitudinally extending from a distal end <NUM> thereof which are utilized as both a coupling mechanism and a deployment mechanism for delivery system <NUM>. Self-expanding first and second frames <NUM>, <NUM>, respectively, are disposed or mounted at a distal portion of delivery system <NUM>. First and second frames <NUM>, <NUM> are disposed in series such that they are adjacent to each other or side-by-side in a longitudinal direction, i.e., along a longitudinal axis LA of delivery system <NUM>. First frame <NUM> is disposed distal to second frame <NUM>, and thus first frame <NUM> may be referred to herein as distal frame <NUM> and second frame <NUM> may be referred to herein as proximal frame <NUM>.

As shown in the perspective views of <FIG>, first and second frames <NUM>, <NUM> are shown in their expanded or deployed configurations and removed from delivery system <NUM> for illustrative purposes only. First and second frames <NUM>, <NUM> each include a self-expanding scaffold <NUM>, <NUM>, respectively, that returns to an expanded deployed state from a compressed or constricted delivery state. In this embodiment, self-expanding scaffolds <NUM>, <NUM> are tubular components having proximal ends or segments <NUM>, <NUM>, respectively, and distal ends or segments <NUM>, <NUM>, respectively, with diamond-shaped openings <NUM>, <NUM>, respectively, that 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. However, it will be understood by one of ordinary skill in the art that the illustrated configurations of first and second frames <NUM>, <NUM> are exemplary and self-expanding scaffolds <NUM>, <NUM> may have alternative patterns or configurations. For example, in another embodiment (not shown), self-expanding scaffolds <NUM>, <NUM> may include one or more sinusoidal patterned rings coupled to each other to form a tubular component. Further, depending upon application thereof and as will be described in more detail herein, the first and/or second frame may each have distinct configurations and/or include an additional element that aids in fixing or anchoring the self-expanding frame within native valve anatomy.

With reference to <FIG>, the main components of delivery system <NUM> will now be described in more detail. Outer sheath component <NUM> is an elongate shaft or tubular component that defines a lumen <NUM> extending from a proximal end <NUM> to a distal end <NUM> thereof. Outer sheath component <NUM> is movable in an axial direction along and relative to inner shaft <NUM> and extends to a proximal portion of the delivery system where it may be controlled via an actuator, such as a handle <NUM> to selectively expand first and second frames <NUM>, <NUM>. Handle <NUM> may be a push-pull actuator that is attached or connected to proximal end <NUM> of outer sheath component <NUM>. Alternatively, the actuator may be a rotatable knob (not shown) that is attached or connected to proximal end <NUM> of outer sheath component <NUM> such that when the knob is rotated, outer sheath component <NUM> is retracted in a proximal direction to expand the first and second frames. Alternatively, the actuator may use a combination of rotation and sliding to retract outer sheath component <NUM>, as described, for example, in <CIT>, <CIT>, <CIT>, and <CIT>. Thus, when the actuator is operated, i.e., manually turned or pulled, outer sheath component <NUM> is proximally retracted over inner shaft <NUM> in a proximal direction. Outer sheath component <NUM> may be constructed of any suitable flexible polymeric material, including but not limited to polyethylene terephalate (PET), nylon, polyethylene, PEBAX, or combinations thereof, either blended or co-extruded.

Elongate tube <NUM> having flat wires <NUM> longitudinally extending from distal end <NUM> thereof is an elongate shaft or tubular component that defines a lumen <NUM> extending from a proximal end <NUM> to distal end <NUM> thereof. Elongate tube <NUM> is slidingly disposed within lumen <NUM> of outer sheath component <NUM>. Elongate tube <NUM> is movable in an axial direction along and relative to inner shaft <NUM> and extends to a proximal portion of the delivery system where it may be controlled via an actuator, such as a handle <NUM> to selectively proximally retract flat wires <NUM>. Handle <NUM> may be a push-pull actuator, a rotatable knob, or an actuator that uses a combination of rotation and sliding to retract the shaft component as described herein with respect to handle <NUM> and is attached or connected to proximal end <NUM> of elongate tube <NUM>. Elongate tube <NUM> may be constructed of any suitable flexible polymeric material, including but not limited to polyethylene terephalate (PET), nylon, polyethylene, PEBAX, or combinations thereof, either blended or co-extruded. A side view of a distal portion of elongate tube <NUM> is shown in <FIG>. Elongate tube <NUM> includes a total of three flat wires 146A, 146B, 146C, collectively referred to herein as flat wires <NUM>, which longitudinally extend from distal end <NUM> of elongate tube <NUM>. More particularly, proximal ends <NUM> of each flat wire <NUM> is attached or fixed to distal end <NUM> of elongate tube <NUM> and distal ends <NUM> are not attached or free ends such that flat wires <NUM> may be woven through first and second frames <NUM>, <NUM> to couple them to the delivery system as will be explained in more detail herein. Although shown with three flat wires <NUM>, it will be understood by those of ordinary skill in the art that a greater or smaller number of flat wires may be used depending upon the size or diameter of first and second frames <NUM>, <NUM>. Further, although flat wires <NUM> preferably having an oval, oblong, or rectangular cross-section and a flat or flattened profile in order to minimize the delivery profile thereof, the wires may alternatively have a circular or other shape cross-section as will be understood by those of ordinary skill in the art. The length of flat wires <NUM> depend upon the length of first and second frames <NUM>, <NUM> as flat wires <NUM> are configured to extend at least approximately the full length of the first and second frames <NUM>, <NUM> when in the compressed delivery configuration. Flat wires <NUM> may be formed from Nitinol, stainless steel, PEEK, or similar materials.

Inner shaft <NUM> is an elongate shaft or tubular component that defines a lumen <NUM> extending from a proximal end <NUM> to a distal end <NUM> thereof. Lumen <NUM> of inner shaft <NUM> is sized to slidingly receive a plunger (shown in <FIG>) with a dilator tip (shown in <FIG>) at a distal end thereof. The plunger defines a guidewire lumen such that delivery system <NUM>, including the plunger extending therethrough, may be advanced over a guidewire (shown in <FIG>) to assist in tracking the delivery system to the target site within the vasculature. Inner shaft <NUM> is slidingly disposed within lumen <NUM> of elongate tube <NUM>. As will be described in more detail herein, distal end <NUM> of inner shaft <NUM> is coupled to proximal end <NUM> of second or proximal frame <NUM>. In an embodiment hereof, distal end <NUM> of inner shaft <NUM> is permanently attached to the proximal end of second or proximal frame <NUM> such that proximal frame <NUM> is a permanent component of the delivery system. In another embodiment hereof, distal end <NUM> of inner shaft <NUM> is releasably coupled to the proximal end of second or proximal frame <NUM> such that proximal frame <NUM> may be selectively detached from the delivery system and thus is not a permanent component of the delivery system. Inner shaft <NUM> is movable in an axial direction along and relative to outer sheath component <NUM> and extends to a proximal portion of the delivery system where it may be controlled via an actuator, such as a handle <NUM> to selectively proximally retract second or proximal frame <NUM>. Handle <NUM> may be a push-pull actuator, a rotatable knob, or an actuator that uses a combination of rotation and sliding to retract the shaft component as described herein with respect to handle <NUM> and is attached or connected to proximal end <NUM> of inner shaft <NUM>. Inner shaft <NUM> may be constructed of any suitable flexible polymeric material, including but not limited to polyethylene terephalate (PET), nylon, polyethylene, PEBAX, or combinations thereof, either blended or co-extruded.

In order to couple first and second frames <NUM>, <NUM> to delivery system <NUM>, distal end <NUM> of inner shaft <NUM> is coupled to proximal end <NUM> of second or proximal frame <NUM> as stated above and second or proximal frame <NUM> is releasably coupled to proximal end <NUM> of first or distal frame <NUM>. In the compressed delivery configuration of <FIG>, outer sheath component <NUM> is in a non-retracted, delivery configuration and is disposed or extends over first and second frames <NUM>, <NUM> such that the first and second frames are held or retained in a compressed delivery configuration therein. As best shown in the sectional view of <FIG>, when in the compressed delivery configuration, first and second frames <NUM>, <NUM> are mounted in series with proximal end <NUM> of first or distal frame <NUM> overlapping distal end <NUM> of second or proximal frame <NUM> to provide a circumferential overlap region <NUM> therebetween. More particularly, distal end or segment <NUM> of second or proximal frame <NUM> is disposed or nested within proximal end or segment <NUM> of first or distal frame <NUM> such that proximal end <NUM> of first or distal frame <NUM> overlays or covers distal end <NUM> of second or proximal frame <NUM> at circumferential overlap region <NUM>. However, as will be understood by those of ordinary skill in the art, proximal end <NUM> of first or distal frame <NUM> may alternatively be disposed within distal end <NUM> of second or proximal frame <NUM> at circumferential overlap region <NUM>.

With additional reference to the enlarged view of <FIG>, flat wires <NUM> are woven through overlapping openings <NUM>, <NUM> of first and second frames <NUM>, <NUM> along circumferential overlap region <NUM> in order to releasably couple first and second frames <NUM>, <NUM> together. The enlarged view of <FIG> illustrates only a single flat wire <NUM> for clarity. In the circumferential overlap region <NUM>, each flat wire <NUM> is threaded under or woven through a respective distalmost crown <NUM> of second or proximal frame <NUM>. More particularly, flat wire <NUM> extends along an outer surface of second or proximal frame <NUM>. Distal to proximal end <NUM> of first or distal frame <NUM> and within circumferential overlap region <NUM>, flat wire <NUM> passes through a first set <NUM> of overlapping openings <NUM>, <NUM> within circumferential overlap region <NUM> such that flat wire <NUM> is disposed within first or distal frame <NUM>. Proximal to distal end <NUM> of second or proximal frame <NUM> and within circumferential overlap region <NUM>, flat wire <NUM> passes through a second set <NUM> of overlapping openings <NUM>, <NUM> within circumferential overlap region <NUM> such that flat wire <NUM> is disposed and extends along an outer surface of first or distal frame <NUM> for the remaining length thereof. As a result, once all flat wires <NUM> are positioned in a similar manner, first or distal frame <NUM> is releasably coupled to second or proximal frame <NUM> as well as to delivery system <NUM> (via second or proximal frame) via flat wires <NUM>.

As shown in <FIG>, proximal retraction of flat wires <NUM> from circumferential overlap region <NUM> releases at least first or distal frame <NUM> from delivery system <NUM>. When flat wires <NUM> are proximally retracted such that they are no longer woven through overlapping openings <NUM>, <NUM> of first and second frames <NUM>, <NUM> along circumferential overlap region <NUM>, first and second frames <NUM>, <NUM> are no longer coupled together via the flat wires. Second or proximal frame <NUM> (which is coupled to inner shaft <NUM>) may be proximally retracted to separate from first or distal frame <NUM>, as shown in <FIG>, such that first or distal frame <NUM> does not contact proximal frame <NUM> and is decoupled from delivery system <NUM>. In <FIG>, flat wires <NUM> are shown radially extending beyond proximal frame <NUM> for illustrative purposes only. When in use, elongate tube <NUM> having flat wires <NUM> longitudinally extending therefrom would be proximally retracted such that flat wires <NUM> were at least partially housed within outer sheath component <NUM>.

More particularly, <FIG> illustrate the steps for deploying first and second frames <NUM>, <NUM> and decoupling at least first or distal frame <NUM> from delivery system <NUM>. In <FIG>, outer sheath component <NUM> is being proximally retracted as shown by directional arrow <NUM> and first or distal frame <NUM> is partially deployed. Although hidden from view in this figure, second or proximal frame <NUM> is compressed and restrained within outer sheath component <NUM> and flat wires <NUM> are woven through overlapping openings <NUM>, <NUM> of first and second frames <NUM>, <NUM> along circumferential overlap region <NUM> in order to releasably couple first and second frames <NUM>, <NUM> together as described with respect to <FIG>. When outer sheath component <NUM> is proximally retracted to uncover first or distal frame <NUM>, flat wires <NUM> slow the self-expansion of the first frame to control deployment thereof. Stated another way, the expansion rate of distal frame <NUM> is slower with flat wires <NUM> disposed thereover as compared to the expansion rate of distal frame <NUM> without flat wires <NUM> disposed thereover. Slower expansion results in more controlled and predictable deployment of distal frame <NUM>.

Retraction of outer sheath component <NUM> continues until first or distal frame <NUM> is completely outside of outer sheath component <NUM> and thus fully expanded as shown in <FIG>. In <FIG>, second or proximal frame <NUM> is partially deployed or expanded with outer sheath component <NUM> still disposed over a proximal portion thereof. At this stage of deployment, flat wires <NUM> are still woven through overlapping openings <NUM>, <NUM> of first and second frames <NUM>, <NUM> along circumferential overlap region <NUM> in order to releasably couple first and second frames <NUM>, <NUM> together as described with respect to <FIG>. When outer sheath component <NUM> is proximally retracted to uncover second or proximal frame <NUM>, flat wires <NUM> slow the self-expansion of the second frame to control deployment thereof. When each of the first and second frames is at least partially expanded distal of outer sheath component <NUM> while remaining coupled to each other by flat wires <NUM>, first and second frames <NUM>, <NUM> are recapturable by outer sheath component <NUM>. More particularly, if repositioning of first frame <NUM> is desired, outer sheath component <NUM> may be distally advanced over flat wires <NUM> and first and second frames <NUM>, <NUM> in order to recapture first and second frames <NUM>, <NUM> within outer sheath component <NUM>. When recaptured, first and second frames <NUM>, <NUM> resume their compressed, delivery configuration described above with respect to <FIG> and first frame <NUM> may be repositioned.

Retraction of outer sheath component <NUM> continues until both first and second frames <NUM>, <NUM> are completely outside of outer sheath component <NUM> and thus fully expanded as shown in <FIG>. At this stage of deployment, flat wires <NUM> are still woven through overlapping openings <NUM>, <NUM> of first and second frames <NUM>, <NUM> along circumferential overlap region <NUM> in order to releasably couple first and second frames <NUM>, <NUM> together as described with respect to <FIG>, and first and second frames <NUM>, <NUM> are still recapturable by outer sheath component <NUM> as described above.

Once first frame <NUM> is positioned as desired (i.e., repositioning is no longer desired and recapturability is thus no longer required), flat wires <NUM> are proximally retracted in order to decouple first or distal frame <NUM> from second or proximal frame <NUM> and delivery system <NUM> as shown in <FIG>. More particularly, elongate tube <NUM> having flat wires <NUM> attached thereto is proximally retracted relative to inner shaft <NUM> until distal ends <NUM> of flat wires <NUM> are positioned proximal to second or proximal frame <NUM>. Distal ends <NUM> are preferably rounded and flat wires <NUM> are sufficiently flexible in order to avoid potential tissue damage during retraction thereof.

After first or distal frame <NUM> is decoupled from delivery system <NUM>, second or proximal frame <NUM> is proximally retracted in order to separate first and second frames <NUM>, <NUM>. More particularly, inner shaft <NUM> having second frame <NUM> coupled thereto is proximally retracted relative to elongate tube <NUM> until a gap or space <NUM> spans between first and second frames <NUM>, <NUM> as shown in <FIG>. As described above, prior to separation thereof, distal end <NUM> of second or proximal frame <NUM> is disposed within proximal end <NUM> of first or distal frame <NUM>. As such, at this stage of deployment, first or distal frame <NUM> is expanded into apposition with the vessel wall and thus remains in position when second or proximal frame <NUM> is proximally retracted and detached therefrom.

After first and second frames <NUM>, <NUM> are separated from each other, inner shaft <NUM> is further proximally retracted relative to outer sheath component <NUM> in order to recapture second or proximal frame <NUM>. As inner shaft <NUM> is pulled into outer sheath component <NUM>, if not previously retracted into outer sheath component <NUM>, flat wires <NUM> are also further proximally retracted relative to outer sheath component <NUM> in order to be recaptured with proximal frame <NUM>. In <FIG>, second or proximal frame <NUM> is shown partially recaptured with outer sheath component <NUM> disposed over a proximal portion thereof. In <FIG>, second or proximal frame <NUM> is shown fully recaptured within outer sheath component <NUM>. Once fully recaptured, second or proximal frame <NUM> may be removed or may be repositioned for deployment thereof. More particularly, when proximal frame <NUM> is a permanent component of the delivery system according to an embodiment hereof as will be described in more detail herein with respect to <FIG>, proximal frame <NUM> is ready for removal once it is decoupled from distal frame <NUM> and recaptured by outer sheath component <NUM>. In another embodiment hereof, when proximal frame <NUM> detachable from the delivery system and is not a permanent component of the delivery system as will be described in more detail herein with respect to <FIG>, proximal frame <NUM> is ready to be positioned for deployment thereof once it is decoupled from distal frame <NUM> and recaptured by outer sheath component <NUM>. Although recapture of second or proximal frame <NUM> is described via proximal retraction of inner shaft <NUM>, it would be understood by those of ordinary skill in the art that the required relative movement between outer sheath component <NUM> and inner shaft <NUM> may be accomplished via distal advancement of outer sheath component <NUM>.

<FIG> illustrate an embodiment hereof in which the first or distal frame is the scaffold of a valve prosthesis that is delivered by delivery system <NUM> and the second or proximal frame is a permanent component of delivery system <NUM>. Flat wires <NUM> and the proximal frame couple the valve prosthesis to delivery system <NUM> and flat wires <NUM> are utilized in deployment of the valve prosthesis. In this embodiment, a first or distal frame <NUM> is the scaffold of a valve prosthesis, and thus first or distal frame <NUM> may be referred to herein as valve frame <NUM> and a second or proximal frame <NUM> may be referred to herein as delivery frame <NUM>.

<FIG> illustrates a distal portion of a distal portion of inner shaft <NUM> having delivery frame <NUM> attached thereto, with inner shaft <NUM> and delivery frame <NUM> removed from the remainder of the delivers- system for illustrative purposes only. In this embodiment hereof, distal end <NUM> of inner shaft <NUM> is permanently attached or secured to a proximal end of delivery frame <NUM> to be slidable therewith. Distal end <NUM> of inner shaft <NUM> may be permanently attached or secured to a proximal end of delivery frame <NUM> via welding, use or more one or adhesives, bonding, or via other mechanical methods known in the art. Delivery frame <NUM> is shown in its expanded or deployed configuration. <FIG> illustrates valve frame <NUM> in its expanded or deployed configuration, removed from the delivery system for illustrative purposes only. Similar to first and second frames <NUM>, <NUM> described above, valve and delivery frames <NUM>, <NUM> each include a self-expanding scaffold <NUM>, <NUM>, respectively, that returns to an expanded deployed state from a compressed or constricted delivery state. In this embodiment, self-expanding scaffolds <NUM>, <NUM> are tubular components having proximal ends or segments <NUM>, <NUM>, respectively, and distal ends or segments <NUM>, <NUM>, respectively, with diamond-shaped openings <NUM>, <NUM>, respectively, that 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 this embodiment, valve frame <NUM> includes a prosthetic valve component <NUM> disposed within and secured to scaffold <NUM>. Prosthetic valve component <NUM> includes 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. <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 prosthetic valve component <NUM> is configured for placement within a native valve having three leaflets such as the aortic, tricuspid, or pulmonary valves, prosthetic valve component <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 prosthetic valve component <NUM> is configured for placement within a native valve having two leaflets such as the mitral valve, prosthetic valve component <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>. Valve frame <NUM> and prosthetic valve component <NUM> may be collectively referred to herein as a valve prosthesis <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.

Valve frame <NUM> may also include a tubular body or graft material <NUM> attached to an inner or outer surface of scaffold <NUM>. It will be understood by one of ordinary skill in the art that at least some portions of scaffold <NUM>. are not covered by the graft material such that flat wires <NUM> may be woven or passed therethrough. Graft material <NUM> may be formed from any suitable biocompatible material, for example and not limited to, a low-porosity woven or knit polyester, DACRON®, polytetrafluoroethylene (PTFE), polyurethane, silicone, or other suitable materials. Graft material <NUM> is thin-walled so that valve frame <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, graft material <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, the graft material could also be a natural material such as pericardium or another membranous tissue such as intestinal submucosa.

It will be understood by one of ordinary skill in the art that the illustrated configuration of scaffold <NUM> is exemplary and scaffold <NUM> may have an alternative pattern or configuration. For example, in another embodiment shown in <FIG>, a scaffold <NUM> of a valve frame <NUM> is shown. Scaffold <NUM> is configured to easily recapture into delivery system <NUM> and controlled release thereof is improved due to the relatively smaller amount of material at the outflow end thereof. More particularly, scaffold <NUM> includes an outflow end <NUM>, an inflow end <NUM>, and an intermediate portion <NUM> extending therebetween. Openings <NUM> of intermediate portion <NUM> are relatively larger in size than openings <NUM> of inflow end <NUM>. Outflow end <NUM> includes three circumferentially spaced-apart extensions <NUM> that are bulged or flared compared to intermediate portion <NUM> and inflow end <NUM>. Outflow end <NUM> thus has a relatively smaller amount of scaffold material compared to the amount of scaffold material at inflow end <NUM>. Due to the configuration of outflow end <NUM>, valve frame <NUM> is relatively easier to recapture via outer sheath component <NUM> of delivery system <NUM>. As shown in <FIG>, outflow end <NUM> has a diameter D<NUM> which is larger than a diameter D<NUM> of opposing inflow end <NUM>. The sizes of diameters D<NUM> and D<NUM> may vary according to a particular patient's anatomy and/or the intended native valve for replacement.

<FIG> illustrate an exemplary method of implanting the above-described valve frame <NUM> within a native valve according to an embodiment hereof. As described above with respect to <FIG>, when in the compressed delivery configuration, valve and delivery frames <NUM>, <NUM> are mounted in series with the proximal end of distal or valve frame <NUM> overlapping the distal end of proximal or delivery frame <NUM> at an overlap region. Valve and delivery frames <NUM>, <NUM> are held in a radially compressed configuration via outer sheath component <NUM>. The radially compressed configurations of valve and delivery frames <NUM>, <NUM> are suitable for percutaneous delivery within a vasculature. As shown in <FIG>, in accordance with techniques known in the field of interventional cardiology and/or interventional radiology, delivery system <NUM> having a plunger <NUM> disposed there-through is transluminally advanced in a retrograde approach over a guidewire <NUM> 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>. Plunger <NUM> includes a dilator tip <NUM> at a distal end thereof. Delivery of delivery system <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, i.e., while being tracked over guidewire <NUM>, valve and delivery frames <NUM>, <NUM> remain compressed within outer sheath component <NUM> of delivery system <NUM>. Delivery system <NUM> is advanced until distal end <NUM> of outer sheath component <NUM> is distal to the native aortic valve AV and disposed within the left ventricle LV as shown in <FIG>. In an embodiment, delivery system <NUM> is advanced approximately <NUM> into the left ventricle LV.

Once delivery system <NUM> is positioned as desired, outer sheath component <NUM> is proximally retracted in order to radially expand or deploy valve and delivery frames <NUM>, <NUM> as shown in <FIG>. At this stage of deployment, flat wires <NUM> are woven through overlapping openings <NUM>, <NUM> of valve and delivery frames <NUM>, <NUM> along a circumferential overlap region <NUM> in order to releasably couple valve and delivery frames <NUM>, <NUM> together as described with respect to <FIG>. The graft material of valve frame <NUM> is not shown in <FIG> for sake of clarity. When outer sheath component <NUM> is proximally retracted to uncover valve and delivery frames <NUM>, <NUM>, flat wires <NUM> slow the self-expansion of valve and delivery frames <NUM>, <NUM> to control deployment thereof. When valve frame <NUM> is at least partially expanded distal of outer sheath component <NUM> while remaining coupled to delivery frame <NUM> by flat wires <NUM>, valve prosthesis <NUM> is recapturable by outer sheath component <NUM> being distally advanced over flat wires <NUM>. More particularly, if repositioning of valve frame <NUM> is desired, outer sheath component <NUM> may be distally advanced over flat wires <NUM> in order to recapture valve and delivery frames <NUM>, <NUM> within outer sheath component <NUM>. When recaptured, valve and delivery frames <NUM>, <NUM> resume their compressed, delivery configuration described above with respect to <FIG> and valve frame <NUM> may be repositioned.

Once valve prosthesis <NUM> is positioned as desired (i.e., repositioning is no longer desired and recapturability is thus no longer required), flat wires <NUM> are proximally retracted in order to decouple valve frame <NUM> from delivery frame <NUM> and delivery system <NUM> as shown in <FIG>. More particularly, elongate tube <NUM> having flat wires <NUM> attached thereto is proximally retracted relative to inner shaft <NUM> until distal ends <NUM> of flat wires <NUM> are positioned proximal to delivery frame <NUM>. Proximal retraction of flat wires <NUM> from valve frame <NUM> releases valve prosthesis <NUM> from delivery system <NUM>.

After valve prosthesis <NUM> is decoupled from delivery system <NUM>, delivery frame <NUM> is proximally retracted in order to separate valve and delivery frames <NUM>, <NUM>. More particularly, inner shaft <NUM> having delivery frame <NUM> attached thereto is proximally retracted relative to elongate tube <NUM> until a gap or space <NUM> spans between valve and delivery frames <NUM>, <NUM> as shown in <FIG>. As described above, prior to separation thereof, the distal end of delivery frame <NUM> is disposed within the proximal end of valve frame <NUM>. As such, at this stage of deployment, valve frame <NUM> is expanded into apposition with the native heart valve, and thus remains in position when delivery frame <NUM> is proximally retracted and detached therefrom.

After valve and delivery frames <NUM>, <NUM> are separated from each other, inner shaft <NUM> is further proximally retracted relative to outer sheath component <NUM> in order to recapture delivery frame <NUM> as shown in <FIG>. As inner shaft <NUM> is pulled into outer sheath component <NUM>, if not previously retracted into outer sheath component <NUM>, flat wires <NUM> are also further proximally retracted relative to outer sheath component <NUM> in order to be recaptured with proximal frame <NUM>. In <FIG>, delivery frame <NUM> is shown partially recaptured with outer sheath component <NUM> disposed over a proximal portion thereof. Once delivery frame <NUM> is fully recaptured within outer sheath component <NUM>, delivery system <NUM> including delivery frame <NUM> attached thereto may be removed.

Advantageously, valve frame <NUM> may be a relatively short valve frame that does not block or extend over the coronary arteries CA as shown in <FIG>. In an embodiment, valve frame <NUM> has a length of <NUM> or less. Delivery frame <NUM> permits the relatively short valve frame <NUM> to be deployed similar to a longer frame via the use of flat wires <NUM> that attach valve frame <NUM> to delivery system <NUM>. More particularly, during the deployment of a self-expanding frame from an outer sheath, the radial force of the frame as it is partially deployed creates a force in the distal direction. When a relatively short frame is released, the frame may move in the direction of the outer sheath retraction and may cant at the implantation site, which is unintentional slanting or tilting of the frame. If a valve prosthesis is not circumferentially centered relative to the native annulus, the deployed valve prosthesis may dislodge from the implantation site and/or undesirable paravalvular leakage and/or regurgitation may occur. Thus, it is important that the valve prosthesis be accurately located relative to the native annulus prior to full deployment of the prosthesis. With relatively longer frames, canting is mitigated by the fact that much of the frame gradually deploys into contact with tissue at the implantation site which provides anchoring and control during deployment before the longer frame is fully released from the outer sheath. Since delivery frame <NUM> and valve frame <NUM> are deployed while coupled together, delivery frame <NUM> and valve frame <NUM> collectively deploy similar to a longer frame and thus reduce the chance of valve frame <NUM> canting. Delivery frame <NUM> and flat wires <NUM> enable the short valve frame <NUM> to be gradually released or deployed, and valve frame <NUM> remains coupled to delivery system <NUM> during deployment thereof so that valve frame <NUM> deploys into contact with tissue at the implantation site prior to release from the delivery system.

<FIG> illustrate an embodiment hereof in which the first or distal frame is a docking frame that is configured to receive the second or proximal frame having a prosthetic valve component secured therein. Thus, in this embodiment, the second or proximal frame is not a permanent component of delivery system <NUM> but rather distal end <NUM> of inner shaft <NUM> is releasably coupled to the proximal end of the second or proximal frame such that the proximal frame may be selectively detached from the delivery system. In this embodiment, a second or proximal frame <NUM> is the scaffold of a valve prosthesis, and thus second or proximal frame <NUM> may be referred to herein as valve frame <NUM> and a first or distal frame <NUM> may be referred to herein as docking frame <NUM>. Flat wires <NUM> of delivery system <NUM> couple docking and valve frames <NUM>, <NUM> together and are utilized in deployment of both of the frames as will be described in more detail herein. Delivery system <NUM> thus is utilized for a two-stage deployment in which docking frame <NUM> and valve frame <NUM> are concurrently delivered or advanced to the target native valve or treatment site but docking frame <NUM> is deployed prior to valve frame <NUM>. Docking frame <NUM> is configured to be released from and implanted by delivery system <NUM> at an implantation site, i.e., within one of a native heart valve or previously implanted prosthetic valve, and thereafter valve frame <NUM> with the prosthetic valve component secured therein is configured to be released from and implanted by delivery system <NUM> within docking frame <NUM>.

More particularly, <FIG> illustrates a distal portion of inner shaft <NUM> having valve frame <NUM> attached thereto, with inner shaft <NUM> and valve frame <NUM> removed from the remainder of the delivery system for illustrative purposes only. In this embodiment hereof, distal end <NUM> of inner shaft <NUM> is releasably attached or secured to a proximal end of valve frame <NUM> to be slidable therewith. More particularly, with reference to <FIG>, distal end <NUM> of inner shaft <NUM> includes a distal hub <NUM> which functions to releasably couple the proximal end of valve frame <NUM> to inner shaft <NUM>. Distal hub <NUM> includes recesses <NUM> while the proximal end of valve frame <NUM> includes paddles <NUM> proximally extending from the proximal end of the valve frame. Paddles <NUM> are configured to mate or be received within recesses <NUM> of distal hub <NUM> to couple valve frame <NUM> to inner shaft <NUM>. However, when it is desired to deploy valve frame <NUM> as described herein, self-expansion of valve frame <NUM> causes paddles <NUM> to release or exit out of recesses <NUM>, thereby decoupling valve frame <NUM> from inner shaft <NUM>. As shown in <FIG>, distal hub <NUM> may also include longitudinal grooves <NUM> configured to allow passage and sliding of flat wires <NUM> longitudinally extending from elongate tube <NUM> thereover. In the embodiment of <FIG>, distal end <NUM> of elongate tube <NUM> includes a distal hub <NUM> for attachment or securement of flat wires <NUM> to elongate tube <NUM>. Flat wires <NUM> may be glued, welded, molded, or otherwise mechanically attached to distal hub <NUM>, and distal hub <NUM> similarly may be glued, welded, molded, or otherwise mechanically attached to distal end <NUM> of elongate tube <NUM>. Although not shown, it will be understood by one of ordinary skill in the art that a distal hub similar to distal hub <NUM> may be incorporated into any embodiment described herein for attaching flat wires <NUM> to distal end <NUM> of elongate tube <NUM>.

Valve frame <NUM> is shown in its expanded or deployed configuration in <FIG>, and docking frame <NUM> is shown in its expanded or deployed configuration in <FIG>, removed from the delivery system for illustrative purposes only. Similar to first and second frames <NUM>, <NUM> described above, docking and valve frames <NUM>, <NUM> each include a self-expanding scaffold <NUM>, <NUM>, respectively, that returns to an expanded deployed state from a compressed or constricted delivery state. In this embodiment, self-expanding scaffolds <NUM>, <NUM> are tubular components having proximal ends or segments <NUM>, <NUM>, respectively, and distal ends or segments <NUM>, <NUM>, respectively, with diamond-shaped openings <NUM>, <NUM>, respectively, that 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 this embodiment, docking and valve frames <NUM>, <NUM> each include a tubular body or graft material <NUM>, <NUM>, respectively, attached to an inner or outer surface of scaffold <NUM>, <NUM>, respectively. Graft material <NUM>, <NUM> may be formed from any suitable biocompatible material, for example and not limited to, a low-porosity woven or knit polyester, DACRON®, polytetrafluoroethylene (PTFE), polyurethane, silicone, or other suitable materials described above with respect to graft material <NUM>.

In this embodiment, valve frame <NUM> includes a prosthetic valve component <NUM> disposed within and secured to scaffold <NUM>. Prosthetic valve component <NUM> is the same as prosthetic valve component <NUM> described above, and includes at least two valve leaflets <NUM> disposed within and secured to scaffold <NUM>. Valve frame <NUM> and prosthetic valve component <NUM> may be collectively referred to herein as a valve prosthesis <NUM>. Docking frame <NUM> is sized or configured to receive valve prosthesis <NUM>. More particularly, docking frame <NUM> is configured to fit and conform to the anatomy when expanded or deployed in situ in order to prevent paravalvular leakage (PVL) and valve prosthesis <NUM> is implanted into docking frame <NUM>. As such, docking frame <NUM> may be designed, sized, or otherwise configured to fit and conform to native heart anatomy at any desired valve location (i.e., aortic, mitral, tricuspid, pulmonic).

<FIG> illustrate an exemplary method of implanting the above-described docking frame <NUM> and valve frame <NUM> within a native valve according to a non-claimed embodiment hereof. As described above with respect to <FIG>, when in the compressed delivery configuration, docking and valve frames <NUM>, <NUM> are mounted in series with the proximal end of distal or docking frame <NUM> overlapping the distal end of proximal or valve frame <NUM>-<NUM> at an overlap region. Docking and valve frames <NUM>, <NUM> are held in a radially compressed configuration via outer sheath component <NUM>. The radially compressed configurations of docking and valve frames <NUM>, <NUM> are suitable for percutaneous delivery within a vasculature. As shown in <FIG>, in accordance with techniques known in the field of interventional cardiology and/or interventional radiology, delivery system <NUM> having a plunger <NUM> disposed there-through is transluminally advanced in a retrograde approach over a guidewire <NUM> 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>. Plunger <NUM> includes a dilator tip <NUM> at a distal end thereof. Delivery of delivery system <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, i.e., while being tracked over guidewire <NUM>, docking and valve frames <NUM>, <NUM> remain compressed within an outer sheath component <NUM> of delivery system <NUM>. Delivery system <NUM> is advanced until distal end <NUM> of outer sheath component <NUM> is distal to the native aortic valve AV and disposed within the left ventricle LV as shown in <FIG>. In an embodiment, delivery system <NUM> is advanced approximately <NUM> into the left ventricle LV.

Once delivery system <NUM> is positioned as desired, outer sheath component <NUM> is proximally retracted in order to radially expand or deploy docking and valve frames <NUM>, <NUM> as shown in <FIG>. At this stage of deployment, flat wires <NUM> are woven through overlapping openings <NUM>, <NUM> of docking and valve frames <NUM>, <NUM> along a circumferential overlap region <NUM> in order to releasably couple docking and valve frames <NUM>, <NUM> together as described with respect to <FIG>. The graft material of docking and valve frames <NUM>, <NUM> is not shown in <FIG> for sake of clarity. When outer sheath component <NUM> is proximally retracted to uncover docking and valve frames <NUM>, <NUM>, flat wires <NUM> slow the self-expansion of docking and valve frames <NUM>, <NUM> to control deployment thereof. When docking frame <NUM> is at least partially expanded distal of outer sheath component <NUM> while remaining coupled to valve frame <NUM> by flat wires <NUM>, docking frame <NUM> is recapturable by outer sheath component <NUM> being distally advanced over flat wires <NUM>. More particularly, if repositioning of docking frame <NUM> is desired, outer sheath component <NUM> may be distally advanced over flat wires <NUM> in order to recapture docking and valve frames <NUM>, <NUM> within outer sheath component <NUM>. When recaptured, docking and valve frames <NUM>, <NUM> resume their compressed, delivery configuration described above with respect to <FIG> and docking frame <NUM> may be repositioned.

Once docking frame <NUM> is positioned as desired (i.e., repositioning is no longer desired and recapturability is thus no longer required), flat wires <NUM> are proximally retracted in order to decouple docking frame <NUM> from valve prosthesis <NUM> and delivery system <NUM> as shown in <FIG>. More particularly, elongate tube <NUM> having flat wires <NUM> attached thereto is proximally retracted relative to inner shaft <NUM> until distal ends <NUM> of flat wires <NUM> are positioned proximal to valve prosthesis <NUM>. Proximal retraction of flat wires <NUM> from docking frame <NUM> releases docking frame <NUM> from delivery system <NUM>.

After docking frame <NUM> is decoupled from delivery system <NUM>, valve frame <NUM> is proximally retracted in order to separate docking and valve frames <NUM>, <NUM>. More particularly, as described above with respect to <FIG>, valve frame <NUM> is releasably coupled to inner shaft <NUM> to be slideable therewith at this stage of deployment. Paddles <NUM> (shown on <FIG>) of valve frame <NUM> are configured to mate or be received within recesses <NUM> of distal hub <NUM> to couple valve frame <NUM> to inner shaft <NUM>. In order to proximally retract valve frame <NUM>, inner shaft <NUM> having valve frame <NUM> coupled thereto is proximally retracted relative to elongate tube <NUM> until a gap or space <NUM> spans between docking and valve frames <NUM>, <NUM> as shown in <FIG>. As described above, prior to separation thereof, the distal end of valve frame <NUM> is disposed within the proximal end of docking frame <NUM>. As such, at this stage of deployment, docking frame <NUM> is expanded into apposition with the native valve and thus remains in position when valve frame <NUM>. is proximally retracted and detached therefrom.

After docking and valve frames <NUM>, <NUM> are separated from each other, inner shaft <NUM> is further proximally retracted relative to outer sheath component <NUM> in order to recapture valve frame <NUM> as shown in <FIG>. Valve prosthesis <NUM> is still releasably coupled to inner shaft <NUM> at this stage of deployment such that valve prosthesis <NUM> is slideable with inner shaft <NUM>. As inner shaft <NUM> is pulled into outer sheath component <NUM>, if not previously retracted into outer sheath component <NUM>, flat wires <NUM> are also further proximally retracted relative to outer sheath component <NUM> in order to be recaptured with valve frame <NUM>. In <FIG>, valve prosthesis <NUM> is shown fully recaptured with outer sheath component <NUM>. Once valve prosthesis <NUM> is fully recaptured within outer sheath component <NUM>, valve prosthesis <NUM> is ready to be positioned for deployment thereof. Thus, in <FIG>, delivery system <NUM> (with outer sheath component <NUM> having valve prosthesis <NUM> radially compressed therein) is distally advanced to position valve prosthesis <NUM> within deployed docking frame <NUM>. When valve prosthesis <NUM> is positioned as desired, i.e., is longitudinally aligned and concentrically aligned within docking frame <NUM>, outer sheath component <NUM> is proximally retracted in order to radially expand or deploy valve frame <NUM> into apposition with docking frame <NUM> as shown in <FIG>. As described above with respect to <FIG>, when valve prosthesis <NUM> is released from outer sheath component <NUM> for deployment, self-expansion of valve frame <NUM> causes paddles <NUM> to release or exit out of recesses <NUM> to decouple valve prosthesis <NUM> from inner shaft <NUM>.

Claim 1:
A delivery system (<NUM>) for transcatheter implantation of a heart valve prosthesis comprising:
an outer sheath component (<NUM>) defining a lumen (<NUM>) therethrough;
self-expanding first and second frames (<NUM>, <NUM>) disposed in series within a distal portion of the outer sheath component (<NUM>) and held in a compressed delivery configuration therein,
a prosthetic valve component (<NUM>) disposed within and secured to the second frame,
wherein the first frame (<NUM>) is a docking frame (<NUM>) that is configured to receive the second frame (<NUM>) with the prosthetic valve component (<NUM>); and
characterized in that the delivery system further comprises an elongate tube (<NUM>) having at least two wires (<NUM>) longitudinally extending from a distal end (<NUM>) thereof, the elongate tube (<NUM>) and the at least two wires (<NUM>) being slidably disposed within the lumen (<NUM>) of the outer sheath component (<NUM>);
wherein in the compressed delivery configuration the at least two wires (<NUM>) longitudinally extend along exterior portions of the first and second frames (<NUM>, <NUM>) and are woven through adjacent ends of the first and second frames (<NUM>, <NUM>) to releasably couple them to each other.