Patent Description:
The present disclosure relates to stented prosthetic heart valves having a paravalvular leakage prevention or mitigation wrap, as well as delivery devices and methods for selectively deploying the wrap.

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 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 crimping 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>et al. 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>et al.

Although transcatheter delivery methods have provided safer and less invasive methods for replacing a defective native heart valve, leakage between the implanted prosthetic valve and the surrounding native tissue is a recurring problem. Leakage sometimes occurs due to the fact that minimally invasive and percutaneous replacement of cardiac valves typically does not involve actual physical removal of the diseased or injured heart valve. Rather, the replacement prosthetic valve is delivered in a compressed condition to the valve site, where it is expanded to its operational state within the native valve. Calcified or diseased native leaflets are pressed to the side walls of the native valve by the radial force of the stent frame of the prosthetic valve. These calcified leaflets can lead to incomplete conformance of the stent frame with the native valve and can be a source of paravalvular leakage ("PVL"). Significant pressure gradients across the valve cause blood to leak through the gaps between the implanted prosthetic valve and the calcified anatomy. When present, such paravalvular leakage is highly detrimental to the patient. Document <CIT> discloses an anti-paravalvular leakage component for a transcatheter valve prosthesis.

The present disclosure addresses problems and limitations associated with the related art.

The invention is a stented prosthetic heart valve as defined by claim <NUM>. As discussed above, stented prosthetic heart valves can leave paravalvular leakage pathways in some patients, particularly patients with very immobile or heavily calcified native valve leaflets. Disclosed embodiments include stented prosthetic heart valves having a stent frame with a wrap that can be optionally deployed, if paravalvular leakage is detected, to fill commissural paravalvular leakage pathways. In other words, the arrangement of the wrap is controlled independently of the configuration (i.e. expansion) of the stent frame. The wrap includes a body of flexible material positioned around an end of the stent frame. In disclosed embodiments, the wrap is configured so that in a deployed position, the wrap bulges outwardly from the stent frame as one end of the wrap is positioned closer to a second, opposing end of the wrap.

Actuation of the wrap can be accomplished in a variety of ways. For example, the delivery device can include a plurality of tethers that are connected to both a movable end of the wrap and a shaft assembly of the delivery device. The shaft assembly is configured to selectively position the tethers and, thus the wrap. Once the wrap is in the deployed position, coupling elements can be utilized to maintain the deployed position of the wrap. Exemplary coupling elements include a ratchet, hooks and barbs. In other embodiments, the wrap is constructed to be biased in the deployed position and will generally remain in the deployed position once forces overcoming the natural bias to maintain the wrap in the delivery position are released.

After the wrap is maintained in the deployed position and the stented prosthetic heart valve hemodynamics and paravalvular leakage are assessed and deemed acceptable, the delivery device is disengaged from the wrap and the stented prosthetic heart valve so that the delivery device can be retracted from the patient.

Specific embodiments of the present disclosure are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms "distal" and "proximal" are used in the following description with respect to a position or direction relative to the treating clinician. "Distal" or "distally" are a position distant from or in a direction away from the clinician. "Proximal" and "proximally" are a position near or in a direction toward the clinician.

Certain aspects of the present disclosure relate to transcatheter stented prosthetic heart valve delivery devices that retain a stented prosthetic heart valve (hereinafter "prosthetic valve") in a compressed arrangement during delivery to a target site and allow the prosthetic valve to expand and deploy at a target site. By way of background, general components of one non-limiting example of a delivery device <NUM> with which the aspects of the present disclosure are useful is illustrated in <FIG>. The delivery device <NUM> is arranged and configured for percutaneously delivering a prosthetic valve (e.g., the prosthetic valve <NUM> of <FIG>) to a patient's defective heart valve (see also, <FIG>). The delivery device <NUM> includes an optional outer sheath assembly <NUM>, a shaft assembly <NUM>, and a handle assembly <NUM>. The shaft assembly <NUM> includes a distal portion <NUM> and terminates at a tip <NUM>. Where provided, the optional outer sheath assembly <NUM> includes a capsule <NUM> selectively disposed over the prosthetic valve <NUM> that sheathes the prosthetic valve <NUM> in the loaded or compressed arrangement and can be retracted by the handle assembly <NUM> to expose the prosthetic valve <NUM>, thus allowing the prosthetic valve <NUM> to expand. In some constructions, the capsule <NUM> and the outer sheath assembly <NUM> are comprised of differing materials and/or constructions, with the capsule <NUM> having a longitudinal length approximating (e.g., slightly greater than) a length of the prosthetic valve <NUM> to be used with the delivery device <NUM>. A material and thickness of the capsule <NUM> is selected to exhibit sufficient radial rigidity so as to overtly resist the expected expansive forces of the prosthetic valve <NUM> when compressed within the capsule <NUM>. However, the capsule <NUM> exhibits sufficient longitudinal flexibility for ready passage through a patient's vasculature and into the native heart valve to be replaced.

One or more elongate tension members <NUM> can optionally be provided to constrain and compress the prosthetic valve <NUM>. Suitable elongate tension members, include, but are not limited to sutures, chords, wires or filaments. The tension member(s) <NUM> can be considered part of the delivery device <NUM> in some embodiments or as part of the prosthetic valve <NUM> in other embodiments. The delivery device <NUM> provides a loaded delivery state (<FIG>) in which the prosthetic valve <NUM> is loaded over the shaft assembly <NUM> and is compressively retained on the distal portion <NUM> by the tension members <NUM>. In some embodiments, compression of the prosthetic valve <NUM> is maintained and adjusted with the tension members <NUM>. Once the loaded and compressed prosthetic valve <NUM> is located at a target site, tension in the tension members <NUM> is lessened or released to permit the prosthetic valve <NUM> to self-expand, partially releasing and ultimately fully deploying the prosthetic valve <NUM> from the shaft assembly <NUM>. The tension members <NUM>, if provided, can be configured to be released from the prosthetic valve <NUM> with the handle assembly <NUM> or the like. After deployment of the prosthetic valve <NUM> at the target site, paravalvular leakage can occur. Therefore, delivery devices <NUM> disclosed herein are configured to selectively actuate a paravalvular leakage prevention wrap <NUM> of the prosthetic valve <NUM>, as will be discussed in further detail below.

<FIG> illustrates, in detail, the non-limiting prosthetic valve <NUM> useful with systems and methods of the present disclosure. As a point of reference, the prosthetic valve <NUM> has a compressed, delivery configuration as is schematically illustrated in <FIG>. The prosthetic valve <NUM> also has a normal, expanded arrangement as is shown in <FIG> and <FIG>, for example. The prosthetic valve <NUM> includes a stent frame <NUM> and a valve structure <NUM>. The stent frame <NUM> is generally tubular and has first and second ends <NUM>, <NUM> and can assume any of the forms described herein, and is generally constructed so as to be self-expandable from the compressed arrangement of <FIG> to the normal, expanded deployed arrangement of <FIG> and <FIG>. In other embodiments, the stent frame <NUM> is expandable to the expanded arrangement by a separate device (e.g., a balloon internally located within the stent frame <NUM>). The valve structure <NUM> is assembled to the stent frame <NUM> and provides two or more (typically three) leaflets <NUM>. The valve structure <NUM> can assume any of the forms described herein, and can be assembled to the stent frame <NUM> in various manners, such as by sewing the valve structure <NUM> to the stent frame <NUM>.

The disclosed prosthetic valve <NUM>, which may be of many configurations as discussed herein, includes a paravalvular leakage prevention and/or mitigation wrap <NUM> (schematically illustrated and shown apart from the prosthetic valve in <FIG> for ease of illustration). In some embodiments, the wrap <NUM> comprises a body <NUM> made of a thin metal mesh material, such as Nitinol™ mesh, a braided or laser cut elastomer such as polyurethane, C-FLEX® biomedical tubing available from Saint-Gobain North America, Malvern, Pennsylvania, silicone or a braided metal such as platinum iridium or cobalt chromium, for example. The body <NUM> can also be constructed of more than one material, for example, the body <NUM> can also include fabric, tissue (e.g., autologous tissue, xenograph material, treated pericardium, porcine, bovine, or equine tissue) or bioabsorbable mesh (e.g., poly(glycerol-co-sebacate), polylactic acid and polycaprolactone).

The prosthetic valve <NUM> is configured so that the wrap <NUM> can be selectively deployed independent of the arrangement of the stent frame <NUM>. For example, <FIG> schematically illustrates the stent frame <NUM> in a delivery arrangement in which the wrap <NUM> is in the delivery position and has approximately the same diameter as the stent frame <NUM>, wherein the wrap diameter D1 is measured as a greatest distance between any two opposing points of the wrap <NUM>. Turning now also to <FIG>, which illustrates the stent frame <NUM> in the expanded arrangement in which the wrap <NUM> has not yet been deployed. Therefore, in <FIG> the diameter D2 of the stent frame <NUM> is approximately the same as the diameter D1 of the wrap <NUM>. In one exemplary deployment position, as illustrated in <FIG>, a first end <NUM> of the wrap <NUM> is moved toward a second end <NUM> of the wrap <NUM> causing the wrap <NUM> to bulge outwardly, thereby expanding the diameter D1 of the wrap <NUM> so that the diameter D1 of the wrap <NUM> is greater than the diameter D2 of the stent frame <NUM> (see also, <FIG>). In an alternate deployment position, illustrated in <FIG>, the second end <NUM> of the wrap <NUM> is moved toward the first end <NUM> to cause the wrap <NUM> to bulge outwardly, also resulting in the diameter D1 of the wrap <NUM> being greater than the diameter D2 of the stent frame <NUM> to mitigate or stop paravalvular leakage at a native heart valve.

The delivery device <NUM> and prosthetic valve <NUM> configurations disclosed herein are beneficial in that the diameter D1 of the wrap <NUM> can be selectively enlarged in situ. In this way, the clinician has the option of whether or not to deploy the wrap <NUM> based on the occurrence or lack of paravalvular leakage after the prosthetic valve <NUM> is deployed at a native heart valve V. For example, see <FIG> illustrating the deployed prosthetic valve <NUM> having the wrap <NUM> that has not yet been deployed. Paravalvular leakage PVL is occurring between the prosthetic valve <NUM> and the native valve V so it is likely that a clinician would opt to deploy the wrap <NUM> upon detection of the leakage PVL. If no paravalvular leakage is detected upon deployment of the prosthetic valve <NUM>, the wrap <NUM> can be left in the first, delivery position in which the wrap <NUM> generally conforms to the stent frame <NUM>.

<FIG> further illustrate the variable diameter D1 of the wrap <NUM>. As noted above, the wrap <NUM> is configured to have a delivery position (<FIG>) and a deployed position (<FIG>) in which the diameter D1 of the wrap <NUM> increases as the wrap <NUM> bulges outwardly. In one illustrative embodiment, a maximum distance D3 that the wrap <NUM> bulges out from the stent frame <NUM> in the deployed position of <FIG> is about <NUM> to about <NUM>.

Actuating selective movement of the wrap <NUM> from the delivery position of <FIG> to the deployed position of <FIG> can be accomplished in a variety of ways. In one such way, as generally depicted in <FIG>, the delivery device <NUM> includes a plurality of tethers <NUM> (e.g., three), such as cables, wires, sutures, chords, filaments, or tension members, that interconnect the tip <NUM> and the wrap <NUM>. The tethers <NUM> can be routed inside the stent frame <NUM>, outside the stent frame <NUM>, or a combination of inside and outside the stent frame <NUM>. In this embodiment, each tether <NUM> has a first end 28a secured to the tip <NUM> and a second end 28b secured to a second end <NUM> of the wrap <NUM> (only end of one tether <NUM> are referenced for ease of illustration). The delivery device <NUM> can be configured to have the second end <NUM> of the wrap <NUM> movable toward the first end <NUM> of the wrap <NUM>, which is fixed to the stent frame <NUM>. In this embodiment, deployment of the wrap <NUM> is actuated by proximally retracting the tip <NUM> past the second end <NUM> of the wrap <NUM> so that the second end <NUM> is brought closer to the first end <NUM>, thus causing the wrap <NUM> to bulge outwardly. In further alternate embodiments which function and are operated similarly, the tether(s) <NUM> are secured to other locations on the shaft assembly <NUM>.

An alternate configuration and method of selectively actuating the wrap <NUM> is shown in <FIG>. In this embodiment, the first end 28a of each tether <NUM> is secured to the tip <NUM> and the second end 28b is secured to the first end <NUM> of the wrap <NUM> (only end of one tether <NUM> are referenced for ease of illustration). The tethers <NUM> can be routed inside the stent frame <NUM>, outside the stent frame <NUM>, or a combination of inside and outside the stent frame <NUM>, as desired. The distal end <NUM> of the wrap is secured to the stent frame <NUM>. Movement of the wrap <NUM> from the delivery position (<FIG>) to the deployed position (<FIG>) is actuated by pushing the tip <NUM> distally. As best seen in <FIG>, actuation of the wrap <NUM> is caused by extending the delivery device <NUM> further into the ventricle outflow tract T, past the second end <NUM> of the prosthetic valve <NUM>, thus pulling the tethers <NUM> distally to subsequently pull the first end <NUM> of the wrap <NUM> toward the second end <NUM>. In further alternate embodiments which function and are operated similarly, the tether(s) <NUM> are secured to other locations of the shaft assembly <NUM>.

Once the wrap <NUM> is maintained in the deployed position via any of the various methods disclosed herein and the prosthetic valve <NUM> hemodynamics and paravalvular leakage are assessed and deemed acceptable, the delivery device <NUM> is disengaged from the wrap <NUM> and the prosthetic valve <NUM> so that the delivery device <NUM> can be retracted from the patient. In one embodiment, illustrated in <FIG>, the wrap <NUM> includes one or more apertures <NUM> through which a respective one of one or more tethers <NUM> is threaded. A first end (see also <FIG>) of each tether <NUM> is secured to the delivery device <NUM> and a second end <NUM> of each tether <NUM> forms a flexible pigtail curve <NUM> that is sufficiently rigid to maintain the respective tether <NUM> to the wrap <NUM> as the wrap <NUM> is pulled into the deployed position of <FIG> and <FIG>. After the wrap <NUM> is deployed, each tether <NUM> remains positioned within the aperture <NUM> unless sufficient pulling force is provided by the delivery device <NUM> via the shaft assembly <NUM> to straighten the pigtail curve <NUM> so that the tether <NUM> can be pulled through the aperture <NUM> to disengage from the wrap <NUM>. All tethers <NUM> can be similarly configured or can have different configurations.

A similar alternate tether <NUM> that can be incorporated into a delivery device (e.g., the delivery device <NUM> of <FIG> and <FIG>) is illustrated in <FIG>. In this embodiment, a first end (see also <FIG>) of each tether <NUM> is secured to the delivery device <NUM> (e.g., to the tip <NUM> or elsewhere) and a second end <NUM> of the tether <NUM> includes a compressible section <NUM> that is sufficiently rigid to maintain the respective tether <NUM> within an aperture <NUM> of the wrap <NUM> as the wrap <NUM> is pulled into the deployed position (<FIG> and <FIG>). After the wrap <NUM> is deployed, the tether <NUM> remains positioned within the aperture <NUM> of the wrap <NUM> unless sufficient pulling force is provided by the delivery device <NUM> (e.g., via the handle assembly <NUM>) to compress the compressible section <NUM> within the aperture <NUM> so that the tether <NUM> can be pulled through the aperture <NUM> to disengage from the wrap <NUM>.

As generally depicted in <FIG>, an alternate configuration and method of selectively actuating the wrap <NUM> comprises having one end 28b of each tether secured to the second end <NUM> of the wrap <NUM> and the other end (not visible) of each tether <NUM> extends through a portion of the stent frame <NUM> proximal of the second end <NUM> and then extend distally to a respective opening <NUM> in the delivery device tip <NUM> or other portion of the shaft assembly <NUM> and then extends proximally through the shaft assembly <NUM> to handle assembly <NUM> (see also <FIG>), wherein handle assembly <NUM> is configured to tension or shorten the length of each tether <NUM> in a proximal direction to deploy the wrap <NUM> as shown in <FIG>. As with prior embodiments, the tethers <NUM> can be routed inside the stent frame <NUM>, outside the stent frame <NUM>, or a combination of inside and outside the stent frame <NUM>. Once the wrap <NUM> has been deployed, the tethers <NUM> can be removed from the wrap <NUM> via a variety of methods. For example, one end of each tether <NUM> can be released and the entirety of the tether <NUM> can be withdrawn from the patient. Alternatively, the tethers <NUM> can be cut from the delivery device <NUM> and left within the patient or released in other ways discussed above.

Similar to that described with respect to <FIG> and <FIG>, a further alternate configuration and method of selectively actuating the wrap <NUM> comprises having one end 28b of each tether <NUM> secured to the first end <NUM> of the wrap <NUM> and the other end (not visible) of each tether <NUM> extends distally to a respective opening <NUM> in the delivery device tip <NUM> or other portion of the shaft assembly <NUM> and then extends proximally through the shaft assembly <NUM> to the handle assembly <NUM> (see also, <FIG>). The handle assembly <NUM> is configured to tension or shorten the length of each tether <NUM> in a proximal direction to deploy the wrap <NUM> to a position substantially similar to what is shown in <FIG>. As desired, the tethers <NUM> can be routed inside the stent frame <NUM>, outside the stent frame <NUM>, or a combination of inside and outside the stent frame <NUM>. Once the wrap <NUM> has been deployed, the tethers <NUM> can be removed from the wrap <NUM> in ways discussed above, for example. In further alternate configurations and methods (not shown) of selectively actuating the wrap <NUM> comprises having each tether <NUM> loop through one end of the wrap <NUM> while both ends of each tether <NUM> extend back to the handle assembly <NUM>, wherein the handle assembly <NUM> can tension or shorten the length of each tether <NUM> in a proximal direction to deploy the wrap <NUM>. Once the wrap <NUM> has been deployed, the tethers <NUM> can be removed from the wrap <NUM> in any of the ways discussed above, for example.

To maintain the wrap <NUM> of any of the disclosed embodiments in the deployed position, the stent frame <NUM> and/or the wrap <NUM> can include one or more coupling elements <NUM> such as a ratchet system or the like. As is generally illustrated in <FIG> one such coupling element or ratchet system <NUM> includes at least one forward facing barb 72a connected to the stent frame <NUM> and angled toward the first end <NUM> of the stent frame <NUM>. Also proximate the first end <NUM> of the stent frame <NUM> is a reverse barb 72b that is angled either perpendicular from the stent frame <NUM> or toward the second end <NUM> of the stent frame <NUM>. As the wrap <NUM> is deployed by the delivery device <NUM>, in this embodiment, the tether <NUM> is pulling the first end <NUM> of the wrap <NUM> toward the second end <NUM>, over the forward facing barb(s) 72a. If the force applied to the wrap <NUM> is greater than the force required to release the tether <NUM>, the tether <NUM> will release from the wrap <NUM>. Otherwise, the reverse barb 72b will force the release of the tether <NUM> from the wrap <NUM> by restricting further movement of the tether <NUM> in the proximal direction, thus increasing tension on the tether <NUM>. When the wrap <NUM> contacts the reverse barb 72b and is pulled in the direction therepast, the tension on the tether <NUM> increases, thereby releasing the tether <NUM>. A hook (not shown) or other similar structure can be arranged on the stent frame <NUM> to function in a similar fashion as the reverse barb 72b. Once the wrap <NUM> released from the tether <NUM>, the forward facing barbs 72a maintain the wrap <NUM> in the deployed position of <FIG>, <FIG>, <FIG> and <FIG>. If the wrap <NUM> is to be deployed, the tethers <NUM> are moved proximally as illustrated in <FIG>. During this process, if there are gaps between the stent frame <NUM> and the patient's anatomy (see also, <FIG>), the wrap <NUM> ratchets proximally down the stent frame <NUM>, billowing out and filling those gaps, if there are no gaps between the stent frame <NUM> and the patient's anatomy, then the wrap <NUM> does not billow out and cannot ratchet down the stent frame <NUM>. During this process, the force required to move the wrap <NUM> is configured to be greater than the force required to release the tether <NUM> so that the tether(s) <NUM> releases from the wrap <NUM>. If the force required to move the wrap <NUM> is less than that to release the tether <NUM> from the wrap <NUM>, the reverse barb 72b will force the release of the tether <NUM> from the wrap <NUM> when the wrap <NUM> is pulled in a direction of the second end <NUM>. This function highlights the importance of the reverse barb 72b that ensures that, when tethers <NUM>, <NUM> are used as illustrated in <FIG>, for example, the pigtail curves <NUM> or compressible sections <NUM> uncouple the respective tether <NUM>, <NUM> from the wrap <NUM> before the wrap <NUM> is pulled below the second end <NUM> of the stent frame <NUM>. In this embodiment, the wrap <NUM> can include a ring or other attachment <NUM> configured to engage the barbs 72a, 72b. The wrap <NUM> can also include a second ring <NUM> at the second end, if desired. It is noted that the ratchet system <NUM> can be oriented in the opposite direction on the stent frame <NUM> when the wrap <NUM> is configured to move proximally into the deployed position as discussed with respect to <FIG> or 10A-10B, for example. The ratchet system <NUM>, if oriented in the opposite direction on the stent frame <NUM>, could be configured to function in a similar manner to maintain the wrap <NUM> in the deployed position.

In further alternate embodiments, the prosthetic valve <NUM> includes an alternate wrap <NUM> that self-transitions from a delivery position (<FIG>) to a deployed position (<FIG>). This self-transitioning function is provided by a plurality of flexible spines <NUM> spaced about the wrap <NUM> between first and second ends <NUM>, <NUM>. The spines <NUM> are configured to be biased into the form of <FIG>. Therefore, if both of the first or second ends <NUM> or <NUM> of the wrap <NUM> are secured to the stent frame <NUM> and then one of those ends <NUM> or <NUM> is released from the stent frame <NUM>, the wrap <NUM> will naturally flex and bow outwardly to the deployed position of <FIG> due to the biasing force of the spines <NUM>. In this embodiment, the spines <NUM> can optionally include apertures <NUM> at the movable end (e.g., the first end <NUM>, however the second end <NUM> could be the movable end as generally depicted in <FIG>) through which an elongate tension member <NUM> can be threaded as shown in <FIG>. The tension member <NUM> can optionally be utilized with the delivery device <NUM> to compress the prosthetic valve (not shown, see also <FIG>) and can also be released from the prosthetic valve <NUM> by the delivery device <NUM>, without the need for tethers <NUM> (see also, e.g., <FIG>), to deploy the wrap <NUM> as once the tension member <NUM> interconnecting the first, movable end <NUM> to the stent frame <NUM> (see also <FIG>) is released, the wrap <NUM> naturally transitions to the deployed position of <FIG>.

In alternate embodiments, largely similar to that of <FIG>, a body <NUM> of the wrap <NUM> can be made of a memory shape material so that the biased deployment arrangement of <FIG> is achieved and maintained with only the body <NUM> itself (i.e. the spines <NUM> can optionally be omitted). In such an embodiment, one of the first and second ends <NUM>, <NUM> of the wrap <NUM> is releasably secured with the tension member <NUM> or the like to the stent frame <NUM> while the other opposing end <NUM> or <NUM> is secured to the stent frame <NUM>. Once the releasably connected end <NUM> or <NUM> is released from the stent frame <NUM>, the wrap <NUM> will naturally transition to its biased form, which is configured to bulge outwardly similar to previously disclosed embodiments (see <FIG> as one example).

As referred to herein, stented prosthetic heart valves or prosthetic valves <NUM> that can be modified to incorporate wraps (e.g., wraps <NUM>, <NUM>) disclosed above and delivered and deployed with devices and methods of the present disclosure may assume a wide variety of different configurations. For example, the prosthetic heart valves can be a biostented prosthetic heart valve having tissue leaflets or a synthetic heart valve having polymeric, metallic, or tissue-engineered leaflets, and can be specifically configured for replacing any heart valve. Thus, the prosthetic valves <NUM> can be generally used for replacement of a native aortic, mitral, pulmonic, or tricuspid valve, for use as a venous valve, or to replace a failed bioprosthesis, such as in the area of an aortic valve or mitral valve, for example.

In general terms, the stents or stent frames <NUM> of the present disclosure are generally tubular support structures having an internal area in which valve structure <NUM> leaflets <NUM> will be secured. The leaflets <NUM> can be formed from a variety of materials, such as autologous tissue, homologous material, xenograph material, or synthetics as are known in the art. The leaflets may be provided as a homogenous, biological valve structure, such as porcine, bovine, or equine valves. Alternatively, the leaflets <NUM> can be provided independent of one another (e.g., bovine, porcine or equine pericardial leaflets) and subsequently assembled to the support structure of the stent frame. In another alternative, the stent frame and leaflets can be fabricated at the same time, such as may be accomplished using high-strength nano-manufactured NiTi films produced at Advance BioProsthetic Surfaces (ABPS), for example. The stent frame support structures are generally configured to accommodate at least two (typically three) leaflets; however, replacement prosthetic valves of the types described herein can incorporate more or less than three leaflets.

Some embodiments of the stent frame <NUM> can be a series of wires or wire segments arranged such that they are capable of self-transitioning from a compressed or collapsed arrangement to the normal, radially expanded arrangement. In some constructions, a number of individual wires comprising the stent frame support structure can be formed of a metal or other material. These wires are arranged in such a way that the stent frame support structure allows for folding or compressing or crimping to the compressed arrangement in which the internal diameter is smaller than the internal diameter when in the normal, expanded arrangement. In the compressed arrangement, such a stent frame support structure with attached leaflets can be mounted onto a delivery device, (e.g., the delivery device <NUM>). The stent frame support structures are configured so that they can be changed to their normal, expanded arrangement when desired, such as by the relative movement of one or more sheaths relative to a length of the stent frame.

The wires of the stent frame support structures in embodiments of the present disclosure can be formed from a shape memory material such as a nickel titanium alloy (e.g., Nitinol™). With this material, the support structure is self-expandable from the compressed arrangement to the normal, expanded arrangement, such as by the application of heat, energy, and the like, or by the removal of external forces (e.g., compressive forces). This stent frame support structure can also be compressed and re-expanded multiple times without damaging the structure of the stent frame. In addition, the stent frame support structure of such an embodiment may be laser-cut from a single piece of material or may be assembled from a number of different components.

The prosthetic valve <NUM> is configured for replacing an aortic valve. Alternatively, other shapes are also envisioned, adapted for the specific anatomy of the valve to be replaced (e.g., prosthetic valves in accordance with the present disclosure can alternatively be shaped and/or sized for replacing a native mitral, pulmonic, or tricuspid valve). Regardless, the valve structure <NUM> can be arranged to extend less than an entire length of the stent frame <NUM>. In particular, the valve structure <NUM> can be assembled to, and extend along, the first end <NUM> of the prosthetic valve <NUM>, whereas the second end <NUM> can be free of the valve structure <NUM> material. A wide variety of other constructions are also acceptable and within the scope of the present disclosure. For example, the valve structure <NUM> can be sized and shaped to extend along an entirety, or a near entirety, of a length of the stent frame <NUM>.

Claim 1:
A stented prosthetic heart valve comprising:
a stent frame (<NUM>) having a compressed arrangement for delivery within a vasculature and an expanded arrangement for deployment within a native heart valve;
valve leaflets (<NUM>) disposed within and secured to the stent frame (<NUM>);
a wrap (<NUM>, <NUM>) encircling the stent frame (<NUM>) and formed of a flexible material; the wrap (<NUM>, <NUM>) having a first end (<NUM>, <NUM>) encircling the stent frame (<NUM>) and an opposing second end (<NUM>, <NUM>) encircling the stent frame (<NUM>), wherein the first end (<NUM>, <NUM>) is coupled to the stent frame (<NUM>) and the opposing second end (<NUM>, <NUM>) is not coupled to the stent frame (<NUM>); the wrap (<NUM>, <NUM>) having a delivery position and a deployed position; wherein the wrap (<NUM>, <NUM>) can be actuated from the delivery position to the deployed position independently of the arrangement of the stent frame (<NUM>); wherein the wrap (<NUM>, <NUM>) is configured so that in a deployed position, the wrap (<NUM>, <NUM>) bulges outwardly from the stent frame as the first end (<NUM>, <NUM>) of the wrap is positioned closer to the opposing second end (<NUM>, <NUM>) of the wrap (<NUM>, <NUM>); and
a plurality of tethers, each tether connected to both a delivery device and the second end (<NUM>, <NUM>) of the wrap (<NUM>, <NUM>).