Patent Description:
The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require replacement of the native valve with an artificial valve. There are a number of known artificial valves and a number of known methods of implanting these artificial valves in humans.

Various surgical techniques may be used to replace or repair a diseased or damaged valve. Due to stenosis and other heart valve diseases, thousands of patients undergo surgery each year wherein the defective native heart valve is replaced by a prosthetic valve. Another less drastic method for treating defective valves is through repair or reconstruction, which is typically used on minimally calcified valves. The problem with surgical therapy is the significant risk it imposes on these chronically ill patients with high morbidity and mortality rates associated with surgical repair.

When the native valve is replaced, surgical implantation of the prosthetic valve typically requires an open-chest surgery during which the heart is stopped and patient placed on cardiopulmonary bypass (a so-called "heart-lung machine"). In one common surgical procedure, the diseased native valve leaflets are excised and a prosthetic valve is sutured to the surrounding tissue at the valve annulus. Because of the trauma associated with the procedure and the attendant duration of extracorporeal blood circulation, some patients do not survive the surgical procedure or die shortly thereafter. It is well known that the risk to the patient increases with the amount of time required on extracorporeal circulation. Due to these risks, a substantial number of patients with defective native valves are deemed inoperable because their condition is too frail to withstand the procedure. By some estimates, more than <NUM>% of the subjects suffering from valve stenosis who are older than <NUM> years cannot be operated on for valve replacement.

Because of the drawbacks associated with conventional open-heart surgery, percutaneous and minimally-invasive surgical approaches are becoming commonplace for patients too frail to withstand the procedure to implant a surgical device. In one technique, a prosthetic valve is configured to be implanted in a much less invasive procedure by way of catheterization. For instance, <CIT> and <CIT> describe collapsible transcatheter heart valves that can be percutaneously introduced in a compressed state on a catheter and expanded in the desired position by balloon inflation or by utilization of a self-expanding frame or stent.

In cases of mitral valve stenosis, the non-circular shape of the mitral valve orifice, as well as the chordae tendineae connected to the ventricular sides of the mitral valve leaflets, can complicate placement and retention of a prosthetic valve in the native mitral valve. Examples of prosthetic valves for placement in the native mitral valve are disclosed in <CIT>, <CIT>, <CIT> and <CIT>. Many existing prosthetic valves are generally cylindrically-shaped and, thus, perivalvular leakage past the prosthetic valve during ventricular systole can be a concern when such valves are implanted in the native mitral valve. Left ventricular outflow tract (LVOT) obstruction can also be associated with existing prosthetic valves when implanted in the native mitral valve. Moreover, many existing prosthetic valves rely on a retention feature that is separate from the prosthetic valve, such as an anchoring device, in order to hold the prosthetic valve in place in the mitral annulus. These systems require a two-step implantation process, in which the anchoring device is first implanted in the mitral annulus, followed by implanting the prosthetic valve within the anchoring device. Accordingly, there is a need for improvements to prosthetic heart valves for implantation in the native mitral valve.

The present disclosure pertains to prosthetic implants, such as prosthetic heart valves, including a frame having struts that curve outwardly from the frame when the frame expands to engage tissue surrounding the prosthetic heart valve. As defined in independent claim <NUM>, a prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular inner frame comprising a plurality of angled first strut members. The inner frame is configured to foreshorten from a first length corresponding to the collapsed configuration to a second length corresponding to the expanded configuration when the prosthetic heart valve is expanded to the expanded configuration. A leaflet structure is situated at least partially within the inner frame. An outer frame is disposed radially outward of the inner frame and coupled to the inner frame, the outer frame being configured to collapse with the inner frame to the collapsed configuration and expand with the inner frame to the expanded configuration. The outer frame comprises a plurality of second strut members. At least respective portions of the second strut members are configured to bend radially outwardly into a curved shape as the inner frame and the outer frame move from the collapsed configuration to the expanded configuration.

In the prosthetic heart valve of claim <NUM>, the second strut members comprise first and second end portions, and the first and second end portions of the second strut members are coupled to the inner frame such that the first and second end portions move toward each other as the outer frame expands to bend the second strut members into the curved shape.

In any or all of the disclosed embodiments, the inner frame comprises an inflow end and an outflow end, and the second strut members extend from the inflow end of the inner frame to the outflow end.

In any or all of disclosed embodiments, the outer frame further comprises circumferentially-extending strut members that interconnect the second strut members.

In any or all of the disclosed embodiments, the inner frame comprises an inflow end and an outflow end, the second strut members are situated around the inner frame, and each of the second strut members branches into two third strut members adjacent the inflow end of the inner frame.

In any or all of the disclosed embodiments, the third strut members extending from a given second strut member curve radially away from the inner frame and are coupled to third strut members of adjacent second strut members.

In any or all of the disclosed embodiments, when the prosthetic heart valve is in the expanded configuration, the second strut members form a first portion of the outer frame having a convex exterior surface, and the third strut members form a second portion of the outer frame comprising an annular flange.

In any or all of the disclosed embodiments, the second strut members comprise tissue-engaging members configured to extend radially outwardly from the second strut members when the second strut members are in the curved shape.

Disclosed herein for reference only is a method that comprises introducing a prosthetic heart valve of any of the disclosed embodiments into a patient's vasculature in the radially collapsed state, advancing the prosthetic heart valve to a treatment site, and radially expanding the prosthetic heart valve such that the inner frame foreshortens and the second strut members of the outer frame bend into the curved shape.

In another representative embodiment, a prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame comprising a plurality of angled first strut members, the frame being configured to foreshorten from a first length corresponding to the collapsed configuration to a second length corresponding to the expanded configuration when the prosthetic heart valve is expanded to the expanded configuration. A leaflet structure is situated at least partially within the frame, and a plurality of second strut members extend longitudinally along at least a portion of the frame and are coupled to the frame. The second strut members are configured to bend radially outwardly as the frame moves from the collapsed configuration to the expanded configuration such that at least one of the second strut members forms a plurality of apices spaced radially outwardly from the frame when the prosthetic heart valve is in the expanded configuration.

In any or all of the disclosed embodiments, at least a portion of the plurality of second strut members comprise tissue-engaging members configured to extend away from the second strut members when the prosthetic heart valve is in the expanded configuration.

In any or all of the disclosed embodiments, the tissue-engaging members extend from apices of the second strut members.

In any or all of the disclosed embodiments, the second strut members comprise a first apex and a second apex when the prosthetic heart valve is in the expanded configuration, and the second apex is spaced radially outwardly from the frame by a greater distance than the first apex.

In another representative embodiment, a prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame comprising a plurality of angled first strut members, the frame being configured to foreshorten from a first length corresponding to the collapsed configuration to a second length corresponding to the expanded configuration when the prosthetic heart valve is expanded to the expanded configuration. A leaflet structure is situated at least partially within the frame, and a plurality of second strut members extend longitudinally along at least a portion of the frame and are coupled to the frame. The second strut members are arranged circumferentially around the frame in a first row and configured to bend radially outwardly form the frame into a curved shape as the frame moves from the collapsed configuration to the expanded configuration. A plurality of third strut members extend longitudinally along at least a portion of the frame and are coupled to the frame. The third strut members are arranged circumferentially around the frame in a second row and are configured to bend radially outwardly form the frame into a curved shape as the frame moves from the collapsed configuration to the expanded configuration. The second strut members of the first row are circumferentially offset from the third strut members of the second row.

In any or all of the disclosed embodiments, the second strut members at least partially overlap with the third strut members in an axial direction when the prosthetic heart valve is in the expanded configuration.

In any or all of the disclosed embodiments, the third strut members comprise reduced width portions configured to induce bending of the third strut members at the reduced width portions.

In another representative embodiment, a prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame comprising a plurality of angled first strut members, the frame being configured to foreshorten from a first length corresponding to the collapsed configuration to a second length corresponding to the expanded configuration when the prosthetic heart valve is expanded to the expanded configuration. A leaflet structure is situated at least partially within the frame, and a plurality of second strut members are coupled to the frame and extend longitudinally along at least a portion of the frame. The second strut members are configured to bend radially outwardly into a curved shape as the frame moves from the collapsed configuration to the expanded configuration. A sealing member extends circumferentially around the frame and is coupled to the second strut members. The sealing member comprises first and second circumferential edges, the second circumferential edge being radially outward of the first circumferential edge when the prosthetic heart valve is in the expanded configuration.

In any or all of the disclosed embodiments, the prosthetic heart valve further comprises a plurality of longitudinally-oriented third strut members coupled to the frame, the third strut members being longitudinally offset from the second strut members along the frame and configured to bend into a curved shape as the frame moves from the collapsed configuration to the expanded configuration.

In any or all of the disclosed embodiments, the sealing member coupled to the second strut members is a first sealing member, and the prosthetic heart valve further comprises a second sealing member extending circumferentially around the frame and coupled to the third strut members.

In any or all of the disclosed embodiments, the first sealing member is angled toward an outflow end of the frame, and the second sealing member is angled toward an inflow end of the frame.

In any or all of the disclosed embodiments, the second strut members comprise tissue-engaging members oriented toward the outflow end of the frame, and the third strut members comprise tissue-engaging members oriented toward the inflow end of the frame.

In any or all of the disclosed embodiments, the first and second sealing members are disposed between the second strut members and the third strut members.

In any or all of the disclosed embodiments, the frame comprises an inflow end and an outflow end, and the prosthetic heart valve further comprises a conduit coupled to the outflow end of the frame and extending in an upstream direction from the frame.

In any or all of the disclosed embodiments, the conduit comprises a sealing member downstream of the prosthetic heart valve, and when the prosthetic heart valve is implanted in a native aortic valve, the sealing member is configured to form a seal in an ascending aorta, and the prosthetic heart valve is configured such that a portion of the blood flow through the prosthetic heart valve enters the conduit, and a portion of the blood flow through the prosthetic heart valve exits the prosthetic heart valve upstream of the sealing member and perfuses coronary arteries of the native aortic valve.

In any or all of the disclosed embodiments, the conduit comprises a stent frame coupled to the frame of the prosthetic heart valve, the stent frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration independently of the frame of the prosthetic heart valve.

In any or all of the disclosed embodiments, the conduit comprises a covering, the covering comprising a sealing member comprising a first circumferential edge coupled to the covering and a free second circumferential edge.

In any or all of the disclosed embodiments, the stent frame comprises a plurality of strut members configured to bend radially outwardly from the stent frame into a curved shape when the stent frame is expanded to the expanded configuration.

In any or all of the disclosed embodiments, the stent frame is coupled to the frame of the prosthetic heart valve with a flexible coupling.

In another representative embodiment, a prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame comprising a plurality of angled first strut members, the frame being configured to foreshorten from a first length corresponding to the collapsed configuration to a second length corresponding to the expanded configuration when the prosthetic heart valve is expanded to the expanded configuration. A leaflet structure is situated at least partially within the frame, and a plurality of second strut members extend longitudinally along at least a portion of the frame and are coupled to the frame. At least a portion of the second strut members comprise tissue-engaging members. At least respective portions of the second strut members are configured to bend radially outwardly into a curved shape as the frame moves from the collapsed configuration to the expanded configuration such that the tissue-engaging members extend outwardly from the second strut members.

In another representative embodiment, a prosthetic implant comprises a prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic heart valve comprises an annular frame comprising a plurality of angled first strut members, the frame being configured to foreshorten from a first length corresponding to the collapsed configuration to a second length corresponding to the expanded configuration when the prosthetic heart valve is expanded to the expanded configuration, the frame comprising an inflow end and an outflow end. A leaflet structure is situated at least partially within the frame, and a plurality of second strut members extend longitudinally along at least a portion of the frame and are coupled to the frame. At least respective portions of the second strut members are configured to bend radially outwardly into a curved shape as the frame moves from the collapsed configuration to the expanded configuration. A conduit is coupled to the outflow end of the frame and extends in an upstream direction from the frame.

In any or all of the disclosed embodiments, the prosthetic heart valve further comprises a first sealing member extending circumferentially around the frame and coupled to the second strut members, the first sealing member being angled toward the outflow end of the frame. The prosthetic heart valve further comprises a second sealing member extending circumferentially around the frame and coupled to the third strut members, the second sealing member being angled toward the inflow end of the frame.

In any or all of the disclosed embodiments, the conduit further comprises a stent frame coupled to the frame of the prosthetic heart valve, the stent frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The stent frame comprises a plurality of strut members configured to bend radially outwardly from the stent frame into a curved shape when the stent frame is expanded to the expanded configuration.

Disclosed herein for reference only is another method that comprises advancing the prosthetic implant of any of the disclosed embodiments to a treatment site in the radially collapsed state, inflating an inflatable expansion device to radially expand the prosthetic heart valve such that the frame foreshortens and the second strut members bend into the curved shape, deflating the inflatable expansion device, positioning the inflatable expansion device within the conduit, and inflating the inflatable expansion device within the conduit to at least partially expand the conduit.

The foregoing and other objects, features, and advantages of the disclosed technology will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.

The present disclosure concerns embodiments of prosthetic heart valves, and prosthetic devices or implants including such prosthetic valves, which include an inner frame and a plurality of strut members configured to bow, arch, or curve radially outwardly from the inner frame as the inner frame moves from a collapsed configuration to an expanded configuration. The outwardly curved strut members can aid in anchoring the prosthetic heart valve in a body lumen without substantially increasing the crimped profile of the implant. In certain embodiments, the strut members can be configured to bow or curve radially outwardly from the frame as the frame foreshortens from a relatively longer collapsed state to a relatively shorter expanded state. In certain embodiments, the strut members can be coupled or secured to the exterior of the frame, or can be integrally formed with the frame and configured to buckle outwardly as the frame expands and foreshortens. The struts can have a variety of lengths and configurations, depending upon the particular requirements of the implant. The struts can extend along the entire length of the valve, or a portion thereof. The prosthetic valves can comprise multiple sets of struts arrayed circumferentially around the inner frame of the valve, and longitudinally and/or circumferentially offset from each other. The struts can be coupled together to form an external frame that can be situated around the inner frame and coupled thereto. The external frame can be configured to form a barrel-shaped portion around the inner frame and a flange-shaped portion extending from one end of the inner frame.

The prosthetic heart valves described herein can also be incorporated into a variety of prosthetic implants, such as graft conduits. In certain configurations, the graft conduits can also include frames having strut members configured to bow or curve radially outwardly as the frame(s) of the conduit expand. Such implants can be useful for bypassing diseased portions of a blood vessel, such as aneurysms. In certain embodiments, the frame(s) of such conduits can be independently expandable such that the prosthetic valve frame and the conduit frame(s) can be expanded in a sequence using existing delivery systems, and need not require specially sized or shaped expansion mechanisms. Incorporating a plurality of such frames can allow the conduits to have any specified length.

Embodiments of the disclosed prosthetic heart valves can be configured for implantation at various locations within the heart (the native aortic, mitral, pulmonary, or tricuspid valves). A representative example is a prosthetic heart valve for replacing the function of the native mitral valve. <FIG> illustrate the mitral valve of the human heart. The mitral valve controls the flow of blood between the left atrium and the left ventricle. After the left atrium receives oxygenated blood from the lungs via the pulmonary veins, the mitral valve permits the flow of the oxygenated blood from the left atrium into the left ventricle. When the left ventricle contracts, the oxygenated blood that was held in the left ventricle is delivered through the aortic valve and the aorta to the rest of the body. Meanwhile, the mitral valve closes during ventricular contraction to prevent blood from flowing back into the left atrium.

When the left ventricle contracts, the blood pressure in the left ventricle increases substantially, which urges the mitral valve closed. Due to the large pressure differential between the left ventricle and the left atrium during this time, a possibility of prolapse, or eversion of the leaflets of the mitral valve back into the atrium, arises. A series of chordae tendineae therefore connect the leaflets of the mitral valve to papillary muscles located on the walls of the left ventricle, where both the chordae tendineae and the papillary muscles are tensioned during ventricular contraction to hold the leaflets in the closed position and to prevent them from extending back towards the left atrium. This generally prevents backflow of oxygenated blood back into the left atrium. The chordae tendineae are schematically illustrated in both the heart cross-section of <FIG> and the top view of the mitral valve of <FIG>.

A general shape of the mitral valve and its leaflets as viewed from the left atrium is shown in <FIG>. Various complications of the mitral valve can potentially cause fatal heart failure. One form of valvular heart disease is mitral valve leak or mitral regurgitation, characterized by abnormal leaking of blood from the left ventricle through the mitral valve back into the left atrium. This can be caused by, for example, dilation of the left ventricle, which can cause incomplete coaptation of the native mitral leaflets resulting in leakage through the valve. Mitral valve regurgitation can also be caused by damage to the native leaflets. Another form of valvular heart disease is mitral valve stenosis, in which the passage through the mitral valve is narrowed due to, for example, calcium deposits or calcification around the mitral valve annulus, resulting in reduced blood from the left atrium into the ventricle during diastole. In these circumstances, it may be desirable to repair the mitral valve, or to replace the functionality of the mitral valve with that of a prosthetic heart valve, such as a transcatheter heart valve.

Some transcatheter heart valves are designed to be radially crimped or compressed to facilitate endovascular delivery to an implant site at a patient's heart. Once positioned at a native valve annulus, the replacement valve is then expanded to an operational state, for example, by an expansion balloon, such that a leaflet structure of the prosthetic heart valve regulates blood flow through the native valve annulus. In other cases, the prosthetic valve can be mechanically expanded to the operational state, or can radially self-expand from a compressed delivery state under its own resiliency when released from a delivery sheath. One embodiment of a prosthetic heart valve is illustrated in <FIG>. A transcatheter heart valve with a valve profile and construction similar to the prosthetic valve shown in <FIG> is the Edwards Lifesciences SAPIEN <NUM>™ valve, which is described in detail in <CIT>.

<FIG> is a top perspective view of the prosthetic valve <NUM> in the orientation in which it is intended to be implanted in the mitral valve, and <FIG> is a bottom perspective view. The prosthetic valve <NUM> in <FIG> has an inflow end <NUM> and an outflow end <NUM>, includes a frame or stent <NUM>, and a leaflet structure comprising a plurality of leaflets <NUM> supported inside the frame <NUM>. In the illustrated embodiment, the leaflet structure includes three leaflets <NUM> configured to collapse in a tricuspid arrangement (<FIG>) similar to the native aortic valve, although the prosthetic valve can also include two leaflets configured to collapse in a bicuspid arrangement in the manner of the native mitral valve, or more than three leaflets, as desired. In some embodiments, a skirt <NUM> can be attached to an inner surface of the frame <NUM> to serve as an attachment surface for the valve leaflets <NUM>.

The frame <NUM> can be formed by a plurality of angled strut members <NUM>, which can form a plurality of apices <NUM> arranged around the inflow and outflow ends of the frame. More specifically, the struts <NUM> can form a plurality of inflow apices 24A at the inflow end <NUM> of the frame, and a plurality of outflow apices 24B at the outflow end <NUM> of the frame. <FIG> illustrates a portion of the frame <NUM> in a laid-flat configuration for purposes of illustration. The strut members <NUM> can be arranged end-to-end to form a plurality of rows or rungs of strut members that extend circumferentially around the frame <NUM>. For example, with reference to <FIG>, the frame <NUM> can comprise a first or lower row I of angled strut members forming the inflow end <NUM> of the frame; a second row II of strut members beneath the first row; a third row III of strut members beneath the second row; a fourth row IV of strut members beneath the third row, and a fifth row V of strut members beneath the fourth row and forming the outflow end <NUM> of the frame.

At the outflow end <NUM> of the frame, the strut members <NUM> of the fifth row V can be arranged at alternating angles in a zig-zag pattern. The strut members <NUM> of the fifth row V can be joined together at their distal ends (relative to the direction of implantation in the mitral valve) to form the outflow apices 24B, and joined together at their proximal ends at junctions <NUM>. The frame <NUM> can also comprise a plurality of commissure windows <NUM> formed between the fourth row IV and the fifth row V of strut members <NUM>. The commissure windows <NUM> can be angularly spaced apart from each other around the circumference of the frame <NUM>, and can be configured to receive portions (e.g., commissure tabs) of the leaflets <NUM> therein to allow the leaflets <NUM> to coapt with each other and form commissures. In certain embodiments, the junctions <NUM> may form part of the commissure windows <NUM>. Additional structure and characteristics of the rows I-V of strut members <NUM> are described in greater detail in <CIT>.

The frame <NUM> can be made of any bio-compatible expandable material that permits both crimping to a radially collapsed state and expansion back to the expanded functional state illustrated in <FIG>. For example, in embodiments where the prosthetic valve is a self-expandable prosthetic valve that expands to its functional size under its own resiliency, the frame <NUM> can be made of Nitinol or another self-expanding material. In other embodiments, the prosthetic valve can be a plastically expandable valve that is expanded to its functional size by a balloon or another expansion device, in which case the frame can be made of a plastically expandable material, such as stainless steel or a cobalt-chromium alloy. Other suitable materials can also be used.

<FIG> illustrate another embodiment of a prosthetic heart valve <NUM> that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. The prosthetic valve <NUM> can include an inflow end generally indicated at <NUM>, and an outflow end generally indicated at <NUM>. The prosthetic valve can further include a ventricular portion <NUM>, a lower portion of which forms part of the outflow end <NUM>, and an atrial portion <NUM> located at the inflow end <NUM> of the prosthetic valve. The ventricular portion <NUM> can comprise a covering or skirt <NUM>, and the atrial portion <NUM> can comprise a covering or skirt <NUM>. The skirts <NUM> and <NUM> are discussed in greater detail below with reference to <FIG>.

Referring to <FIG>, in the expanded configuration the ventricular portion <NUM> can curve, bow, arch, or bulge radially outwardly relative to a longitudinal axis <NUM> of the prosthetic valve such that an exterior surface <NUM> of the ventricular portion <NUM> is convex. For example, in the illustrated embodiment the prosthetic valve can be shaped like a vase, wherein the ventricular portion <NUM> has a diameter D<NUM> at the outflow end <NUM> that increases in a direction toward the inflow end <NUM> along the positive y-axis (note Cartesian coordinate axes shown) to a maximum diameter D<NUM> at a shoulder <NUM>. Continuing in a direction along the positive y-axis, the diameter of the ventricular portion <NUM> can decrease from the diameter D<NUM> back to approximately the diameter D<NUM> at a neck portion <NUM> that denotes the transition from the ventricular portion <NUM> to the atrial portion <NUM>. In other embodiments, the diameter of the neck portion <NUM> can be larger or smaller than the diameter D<NUM> at the outflow end <NUM>.

The atrial portion <NUM> can comprise an annular flange-like structure extending upwardly (e.g., proximally) and/or radially outwardly from the neck portion <NUM> proximate the inflow end <NUM> of the prosthetic valve. With reference to <FIG>, in the illustrated embodiment the atrial portion <NUM> can have a diameter D<NUM> measured at diametrically opposite points on the edge of the atrial skirt member <NUM>. In certain embodiments, the diameter D<NUM> of the atrial portion <NUM> can be greater than the diameter D<NUM> of the shoulder <NUM> of the ventricular portion.

<FIG> illustrates the prosthetic valve <NUM> with the skirts <NUM> and <NUM> removed for purposes of illustration. As illustrated in <FIG>, the prosthetic valve <NUM> can comprise an inner frame configured as the frame <NUM> of the prosthetic valve <NUM> of <FIG>. As shown in <FIG> and <FIG>, the frame <NUM> can include the leaflets <NUM>, the skirt <NUM>, etc. (these components are removed from the frame in <FIG> for purposes of illustration). Referring again to <FIG>, the prosthetic valve <NUM> can further comprise an outer frame <NUM> coupled to the inner frame <NUM>, and configured to form the ventricular portion <NUM> and the atrial portion <NUM>. The frame <NUM> can also be configured to move between the radially collapsed configuration and the radially expanded configuration together with the inner frame <NUM>.

The outer frame <NUM> can comprise a plurality of strut members <NUM> circumferentially spaced apart from each other around the inner frame <NUM>. The strut members <NUM> can be configured such that the outer frame <NUM> comprises a ventricular portion <NUM> corresponding to the ventricular portion <NUM> of the prosthetic valve <NUM>, and an atrial portion <NUM> corresponding to the atrial portion <NUM> of the prosthetic valve <NUM>. <FIG> illustrates a representative embodiment of the outer frame <NUM> in a radially collapsed configuration, and <FIG> illustrates a portion of the outer frame <NUM> of <FIG> in a laid-flat configuration for purposes of illustration.

Referring to <FIG>, <FIG>, <FIG>, the strut members <NUM> can comprise first end portions <NUM> and second end portions <NUM>. With reference to <FIG> (which schematically show the struts <NUM> coupled to the inner frame <NUM> for purposes of illustration), the first end portions <NUM> can be coupled to the fifth rung V of strut members <NUM> of the inner frame <NUM> at, for example, the junctions <NUM> between the outflow apices 24B. The second end portions <NUM> can be coupled to the inner frame <NUM> at the first rung I of strut members <NUM> at, for example, the inflow apices 24A. With reference to <FIG> and <FIG>, in the illustrated embodiment the first end portions <NUM> and the second end portions <NUM> of the struts <NUM> are coupled to the struts <NUM> by suturing, although the struts may also be coupled together by welding, brazing, adhesive, any combination thereof, and/or or other coupling means.

Referring to <FIG>, in the expanded configuration, the strut members <NUM> can comprise apices or shoulders <NUM> corresponding to the shoulder <NUM> of the ventricular portion <NUM>. The portions of the struts <NUM> between the first end portions <NUM> and the apices <NUM> can be angled away from the central axis <NUM> (<FIG>) of the prosthetic valve such that the apices <NUM> are spaced radially apart from the inner frame <NUM>. Moving in a direction along the positive y-axis from the apices <NUM> toward the inflow end <NUM>, the strut members <NUM> can curve radially inwardly toward the inner frame <NUM> to the second end portions <NUM>. The second end portions <NUM> can be configured as apices as well, and can be offset radially inwardly from the apices <NUM> and in a direction toward the inflow end <NUM> (e.g., proximally).

Referring to <FIG>, <FIG>, at or proximate to the second end portions <NUM>, each of the strut members <NUM> can split or divide into two strut members 130A and 130B, which are collectively referred to herein as "atrial strut members. " In the illustrated embodiment, in the expanded configuration the atrial strut members 130A and 130B of each strut member <NUM> can diverge circumferentially from each other beginning at the second end portions <NUM>. The atrial strut members 130A, 130B can then merge with the adjacent strut member 130A or 130B of the adjacent strut member <NUM> to form proximal apices <NUM> at the inflow end <NUM> of the prosthetic valve. In the embodiment illustrated in <FIG>, the second end portions <NUM> of the struts <NUM> are adjacent or contacting the inflow end <NUM> of the inner frame <NUM>. Referring to <FIG>, moving in the direction of the positive y-axis (e.g., in the proximal or upstream direction), the struts 130A and 130B can curve radially outwardly from their origins at the second end portions <NUM> such that the proximal apices <NUM> are spaced radially outward from the inflow end <NUM> of the inner frame <NUM> to form the atrial portion <NUM>.

<FIG> illustrates the outer frame <NUM> in a radially collapsed state. The strut members <NUM> can comprise a plurality of openings <NUM> spaced axially along the length of the struts <NUM>. The openings <NUM> can provide locations for suture attachment between the inner frame <NUM> and the outer frame <NUM>, and/or between the strut members <NUM> and the ventricular skirt <NUM>. More specifically, the first end portions <NUM> of the struts <NUM> can comprise round or circular atraumatic suture openings <NUM>, and the apices <NUM> formed by the respective pairs of atrial strut members 130A and 130B can comprise round or circular atraumatic suture openings <NUM>.

The strut members <NUM> can also comprise a plurality of tissue-engaging elements configured as pointed prongs or barbs <NUM>. The barbs <NUM> can be situated within respective openings <NUM> defined in the strut members <NUM>. In certain embodiments, the barbs <NUM> can be configured such that they are positioned within their respective opening <NUM> when the outer frame <NUM> is in the radially collapsed state (<FIG>), and can point outwardly from the openings <NUM> when the frame <NUM> is in the expanded state to engage surrounding tissue (<FIG> and <FIG>). In the configuration illustrated in <FIG>, the frame comprises two rows of barbs <NUM> located between the first end portions <NUM> and the second end portions <NUM> of the struts <NUM>. However, the frame can comprise a single row of barbs, more than two rows of barbs (see <FIG>), or no barbs (<FIG>), depending upon the particular application.

The ventricular strut members <NUM> and/or the atrial strut members 130A, 130B of the outer frame <NUM> can be coupled to the inner frame <NUM> at any of various locations on the inner frame <NUM>. For example, <FIG> schematically illustrate the first end portions <NUM> of the strut members <NUM> of the outer frame <NUM> coupled to the junctions <NUM> of the fifth row V of strut members <NUM> of the inner frame <NUM>. In this configuration, the second end portions <NUM> of the strut members <NUM> can be coupled to the inflow apices 24A and/or at the first row I of strut members <NUM> of the inner frame <NUM>. In <FIG>, along with <FIG> and 14A-14B discussed below, the atrial strut members 130A and 130B are omitted for ease of illustration, but can be present in any of the disclosed embodiments. Referring to <FIG>, the first end portions <NUM> of the struts <NUM> may also be coupled to the outflow apices 24B of the inner frame, and the second end portions <NUM> can be coupled to junctions <NUM> of the strut members <NUM> of the first row I opposite the inflow apices 24A. Referring to <FIG>, in another embodiment the first end portions <NUM> can be coupled to the fourth row IV of strut members <NUM>, and the second end portions <NUM> can be coupled to the inflow apices 24A. In the configuration shown in <FIG>, the strut members <NUM> can be shorter than in the previous, although in other embodiments the struts can be configured to extend outwardly from the frame by a greater distance than in the configurations shown in <FIG> and 13A-13B. Varying the length and attachment points of the strut members <NUM> can vary the size and shape of the resulting ventricular portion <NUM> of the prosthetic valve when the prosthetic valve is expanded.

In certain embodiments, the outer frame <NUM> can be made from self-expanding materials such as Nitinol, or from plastically expandable materials such as stainless steel or a cobalt-chromium alloy. In certain embodiments, the outer frame <NUM> can be laser cut from metal tube in a pattern similar to that shown in <FIG>. In other embodiments, the struts of the outer frame <NUM> can be separately formed and attached to each other by, for example, welding or brazing.

In certain embodiments, the atrial strut members 130A and 130B can be shape-set to have a curved, outwardly-extending shape prior to assembly of the outer frame <NUM> on to the inner frame <NUM>. <FIG> illustrates the outer frame <NUM> in the radially collapsed state with the atrial strut members 130A and 130B shape-set such that they curve upwardly and radially outwardly from the second end portions <NUM> of the ventricular strut members <NUM> and form an umbrella-shaped array about the longitudinal axis of the outer frame <NUM>. Starting from the second end portions <NUM> of the struts <NUM> and moving along the struts 130A and 130B toward the apices <NUM>, the struts 130A and 130B can initially extend upwardly, proximally, or upstream to apices generally indicated at <NUM>, before curving downwardly or distally to the apices <NUM>.

As noted above, in certain embodiments the atrial portion <NUM> can form a flange extending around the inflow end of the frame <NUM>. The flange formed by the atrial portion <NUM> can be flat or planar, or can be curved with respect to one or more planes. For example, the flange formed by the atrial portion <NUM> in the illustrated embodiment can comprise a curving, wavy, or frilled radially outward edge where the covering <NUM> is draped between strut members 130A and 130B. The atrial portion <NUM> can be curved, crowned, or cambered radially outward and toward the outflow end of the inner frame (e.g., downwardly as in <FIG>), or can curve or extend radially away from the inflow end similar to <FIG>.

In certain embodiments, the curved shape of the atrial struts 130A, 130B can be obtained using a correspondingly shaped mandrel. <FIG> illustrates the outer frame <NUM> situated in a representative embodiment of a mandrel <NUM> that can be used to shape-set the atrial strut members 130A and 130B into the desired configuration. <FIG> illustrate the mandrel <NUM> in greater detail. The mandrel <NUM> can comprise a cylindrical first portion <NUM> and a second domed portion <NUM> extending radially outwardly from the first portion <NUM> and having a curved exterior surface <NUM>. Referring to <FIG>, the first portion <NUM> of the mandrel can comprise a passage or lumen <NUM> extending along the length of the first portion <NUM> and configured to receive the cylindrically arranged struts <NUM>. In certain embodiments, the atrial struts 130A and 130B of the outer frame <NUM> can be coupled or fastened to the second portion <NUM> (e.g., by tying with wire or suture) such that the struts 130A and 130B conform to the shape of the surface <NUM> and acquire a curved shape corresponding to the shape of the surface <NUM>. For example, in the illustrated embodiment the second portion <NUM> of the mandrel can comprise a series of circumferentially arranged openings <NUM> and <NUM> through which suture, loops, or thread can be inserted to secure the struts 130A, 130B to the mandrel. In certain embodiments, the mandrel <NUM> can comprise a metal or metal alloy, and/or a high-temperature polymeric material such that the frame <NUM> can be shape set by application of heat.

<FIG> illustrate additional embodiments of mandrels that can be used to prepare or shape set the outer frame <NUM>. The mandrel <NUM> in <FIG> comprises a cylindrical first portion <NUM>, a cylindrical second portion <NUM> having a greater diameter than the first portion <NUM>, and comprising a flat upper surface <NUM>. A lumen <NUM> extends from the upper surface of the second portion <NUM> through the first portion <NUM>. <FIG> illustrates another configuration in which the second portion <NUM> comprises a beveled edge.

In certain embodiments, the struts <NUM> can be shape-set to have a curved shape, such as by heat treatment, optionally in combination with a correspondingly-shaped mandrel.

<FIG> schematically illustrates the frame <NUM> and the frame <NUM> in the collapsed configuration. In the collapsed configuration, the ventricular strut members <NUM> of the frame <NUM> can be straight or nearly straight, and can be situated adjacent or against the exterior of the inner frame <NUM>. In the collapsed configuration, the frame <NUM> can have a first length L<NUM>. When the frame <NUM> is expanded to its functional size, the frame <NUM> can foreshorten as the angles between the strut members increase and the cells in the frame open. Thus, with reference to <FIG>, when the frame assembly is expanded to the expanded configuration, the length of the frame <NUM> can shorten to a second length L<NUM>. The reduction in length of the frame <NUM> can cause the ventricular strut members <NUM> of the frame <NUM> to bow or arch such that the struts <NUM> curve radially outwardly from the inner frame <NUM> to form the ventricular portion <NUM> of the prosthetic valve. Thus, in particular embodiments, by virtue of the attachment of the opposing end portions of the struts <NUM> to the inner frame <NUM> and the foreshortening of the inner frame, opposed axial forces are applied to the opposite ends of the struts <NUM>, causing them to buckle outwardly and away from the inner frame <NUM>. In embodiments in which the outer frame <NUM> comprises a self-expanding material, foreshortening of the inner frame <NUM> can resiliently flex or bend the struts <NUM>. In embodiments in which the struts <NUM> are shape-set to a curved shape, foreshortening of the frame <NUM> can allow the struts to return to the shape-set curved shape.

The prosthetic valve <NUM> can be assembled by at least partially expanding a preassembled prosthetic valve <NUM> including a frame <NUM> and a leaflet structure, and expanding an outer frame <NUM> by a corresponding amount. The outer frame <NUM> can be situated around the frame <NUM>, and the ventricular strut members <NUM> can be attached to the strut members <NUM> of the frame <NUM>, as described above. The ventricular skirt <NUM> can be secured to the ventricular strut members <NUM> of the outer frame <NUM>, and the atrial skirt <NUM> can be secured to the atrial strut members 130A, 130B of the outer frame.

<FIG> illustrates the ventricular skirt <NUM> in greater detail. In the illustrated embodiment, the ventricular skirt <NUM> can comprise a rectangular piece of material. In certain embodiments, the ventricular skirt <NUM> can comprise for example, any of various woven fabrics, such as gauze, polyethylene terephthalate (PET) fabric (e.g., Dacron), polyester fabric, polyamide fabric, or any of various non-woven fabrics, such as felt. In certain embodiments, the ventricular skirt can also comprise a film including any of a variety of crystalline or semicrystalline polymeric materials, such as polytetrafluorethylene (PTFE), PET, polypropylene, polyamide, polyetheretherketone (PEEK), etc. As the prosthetic valve expands, the struts <NUM> can pull the skirt <NUM> into the barrel or convex shape shown in <FIG> and <FIG>.

Another embodiment of the ventricular skirt <NUM> is illustrated in <FIG>, in which the skirt includes recesses or notches <NUM>. In certain embodiments, the notches <NUM> can allow the skirt <NUM> to accommodate the struts <NUM> at their various connections to the inner frame <NUM>.

In use, the prosthetic valve <NUM> can be crimped onto a delivery apparatus for delivery to the treatment site. <FIG> illustrates a representative embodiment of a delivery apparatus <NUM> that can be used to deliver a prosthetic heart valve to a patient. The delivery apparatus <NUM> is exemplary only, and can be used in combination with any of the prosthetic heart valve embodiments described herein. Likewise, the prosthetic heart valves disclosed herein can be used in combination with any of various known delivery apparatuses. The delivery apparatus <NUM> illustrated can generally include a steerable guide catheter <NUM> and a balloon catheter <NUM> extending through the guide catheter <NUM>. A prosthetic device, such as a prosthetic heart valve shown schematically at <NUM>, can be positioned on the distal end of the balloon catheter <NUM>. The guide catheter <NUM> and the balloon catheter <NUM> can be adapted to slide longitudinally relative to each other to facilitate delivery and positioning of the prosthetic heart valve <NUM> at an implantation site in a patient's body. The guide catheter <NUM> includes a handle portion <NUM> and an elongated guide tube or shaft <NUM> extending from the handle portion <NUM>.

<FIG> illustrates the prosthetic valve <NUM> crimped on a balloon <NUM> on the distal end portion of the balloon catheter <NUM>. Due to the shape-set of the outer frame <NUM>, the struts 130A and 130B of the atrial portion <NUM> can bend and extend radially away the collapsed ventricular portion <NUM>.

<FIG> illustrates the prosthetic valve <NUM> enclosed within a cap, capsule, or sheath loader <NUM> on the distal end of the balloon catheter <NUM>. The loader <NUM> includes a first portion <NUM> shown in solid lines and a second portion <NUM> shown in dashed lines. The second portion <NUM> is configured as a sheath to receive the prosthetic valve <NUM> crimped around the balloon <NUM>. The atrial portion <NUM> can be folded proximally such that it lies against the balloon <NUM> and/or against the balloon catheter <NUM>, and is held in place by the loader <NUM>.

The prosthetic valve <NUM> can be implanted in the mitral valve using a trans-septal technique, which can comprise inserting a catheter into the right femoral vein, up the inferior vena cava and into the right atrium. The septum is then punctured and the catheter passed into the left atrium. Once located in the mitral valve, the prosthetic valve <NUM> can be expanded to its functional size to regulate the flow of blood from the left atrium into the left ventricle. <FIG> illustrates the prosthetic valve <NUM> implanted within a native mitral valve <NUM>. The native mitral valve <NUM> can comprise an anterior leaflet <NUM> and a posterior leaflet <NUM> extending from a mitral valve annulus <NUM>. The left atrium is illustrated at <NUM>, and the left ventricle is illustrated at <NUM>. The prosthetic valve <NUM> can be deployed in the mitral valve <NUM> such that the atrial portion <NUM> is located in the left atrium <NUM>. In certain embodiments, the atrial portion <NUM> can contact the lower surface or floor <NUM> of the left atrium <NUM> around the mitral annulus <NUM> to provide stability.

Meanwhile, the ventricular portion <NUM> of the prosthetic valve can extend through the native mitral valve between the leaflets <NUM> and <NUM> such that the ventricular portion <NUM> is at least partially disposed in the left ventricle <NUM>. In certain embodiments, the shoulder <NUM> of the ventricular portion <NUM> can be larger than the orifice of the mitral valve <NUM> such that the shoulder <NUM> engages the leaflets <NUM>, <NUM> and/or the walls of the left ventricle <NUM> below the mitral valve. This can help to prevent the prosthetic valve <NUM> from becoming dislodged (e.g., into the left atrium <NUM>) during ventricular systole. Additionally, the native leaflets <NUM> and <NUM> can lie against the exterior surface of the ventricular portion <NUM>, and may be engaged by the tissue-engaging elements <NUM> to aid in retaining the prosthetic valve <NUM> in position. In certain embodiments, the external frame <NUM> can allow the prosthetic valve <NUM> to be implanted in the mitral valve annulus without separate fixation or anchoring devices.

<FIG>, and <FIG> illustrate other embodiments of the outer frame <NUM>. <FIG> illustrate another configuration of the outer frame <NUM>. In the embodiment of <FIG>, the outer frame <NUM> comprises five rows of tissue-engaging members <NUM>. The first end portions <NUM> of the struts <NUM> are also interconnected and spaced apart by U-shaped members <NUM>. The members <NUM> originate from the first end portion <NUM> of a given strut <NUM>, extend toward the second end portion <NUM> in a space or gap <NUM> between adjacent struts, curve around at an apex, and extend back to toward the first end portion <NUM> and connect to the adjacent strut <NUM>. The gap <NUM> can be enclosed by atrial struts 130B and 130A of adjacent ventricular struts <NUM>. When the frame <NUM> is expanded, the members <NUM> can extend or expand circumferentially between the struts <NUM> to interconnect the struts at the outflow end of the frame, as shown in <FIG>.

<FIG> illustrates another embodiment of an outer frame <NUM> that can be used in combination with the inner frame <NUM>, or any of the other frames described herein. The frame <NUM> can comprise a plurality of first strut members configured as main struts or ventricular struts <NUM>. The ventricular struts <NUM> can comprise first end portions <NUM> corresponding to the outflow end <NUM> of the assembled valve (see <FIG>), and second end portions or junctions <NUM> offset from the first end portions toward the inflow end <NUM>. The ventricular struts <NUM> can branch at a first junction <NUM> to form curved members <NUM> that extend toward the inflow end <NUM> before doubling back toward the outflow end <NUM> and connected to the junction <NUM> of an adjacent strut <NUM> to interconnect the struts <NUM>. When expanded, the members <NUM> can interconnect adjacent ventricular struts <NUM>, similar to the members <NUM> above. The struts <NUM> can divide or branch again at the junctions <NUM> to form atrial struts 182A and 182B. The atrial strut 182A of a given ventricular strut <NUM> can be coupled to the atrial strut 182B of an adjacent ventricular strut <NUM> to form apices <NUM>, similar to the embodiments described above. In the illustrated configuration, the outer frame <NUM> does not include barbs or other tissue-engaging members, although in other embodiments the outer frame can include any number of tissue-engaging members arranged in any selected configuration.

<FIG> illustrates another embodiment of a prosthetic heart valve <NUM> including a ventricular portion <NUM> similar to the prosthetic valve <NUM>, but without an atrial portion. The prosthetic valve <NUM> can include an outer frame <NUM> situated about or around the outside of an inner frame configured as the frame <NUM> of <FIG>. The outer frame <NUM> can comprise a plurality of first strut members <NUM> extending longitudinally between an inflow end <NUM> and an outflow end <NUM>. The strut members <NUM> can be interconnected at their inflow ends by circumferentially extending, zig-zagging second strut members <NUM>, and at their outflow ends by similarly configured third struts <NUM>. <FIG> illustrates the frame <NUM> in the radially collapsed configuration, and <FIG> illustrates the outer frame <NUM> in a laid-flat configuration for purposes of illustration. In the illustrated configuration, the outer frame <NUM> can comprise three rows of barbs <NUM>, although the frame can include any number of rows of barbs, including no barbs. When implanted at the mitral valve, the prosthetic valve <NUM> can be located at least partially within the left ventricle. In certain embodiments, the diameter of the prosthetic valve <NUM> (e.g., of the outer frame <NUM> can be larger than the orifice of the mitral valve such that the frame <NUM> engages the leaflets and/or the walls of the left ventricle below the mitral valve to keep the prosthetic valve in place. The native leaflets of the mitral valve may also lie against the exterior surface of the ventricular portion <NUM>, and may be engaged by the barbs <NUM>.

<FIG> illustrate another embodiment of a prosthetic heart valve <NUM> including an inner frame configured as the frame <NUM> of <FIG>. The prosthetic valve <NUM> is shown configured for implantation in the mitral valve, but can also be configured for implantation in other heart valve such as the aortic valve. The inflow end <NUM> of the inner frame <NUM> is shown at the top of the figure in <FIG>, and <FIG> illustrates a plan view of the prosthetic heart valve looking toward the outflow end <NUM>. The prosthetic valve <NUM> can further comprise a plurality of strut members <NUM> disposed around the exterior of the frame <NUM>. With reference to <FIG>, each of the strut members <NUM> can comprise a main body <NUM> having a first end portion <NUM> and a second end portion <NUM>. The main body <NUM> can have a repeatedly curving or undulating shape in the manner of a sine wave. For example, beginning from the first end portion <NUM> and moving in a direction along the positive y-axis, the main body <NUM> can comprise a first apex or crest <NUM> located radially outward of the first end portion <NUM> (e.g., spaced from the first end portion <NUM> along the positive x-axis). Continuing in the positive y-direction, the main body <NUM> can then curve radially inwardly toward a second apex or trough <NUM>, then radially outward to a third apex configured as a crest <NUM>, and then radially inward to the second end portion <NUM>. In the illustrated embodiment, the strut members <NUM> can comprise a pair of tissue-engaging members configured as barbs or tines <NUM> coupled to the crest <NUM> and extending along the positive y-axis in the direction of the inflow end of the prosthetic valve <NUM>.

Referring to <FIG>, the first end portions <NUM> of the strut members <NUM> can be coupled to the fourth row IV of struts <NUM> of the inner frame <NUM> (see <FIG>), and the second end portions <NUM> can be coupled to the first rung I of struts <NUM> at, for example, the inflow apices 24A. The tissue-engaging members <NUM> of the struts <NUM> can extend in the positive y-direction (e.g., in the proximal or upstream direction) to engage the surrounding tissue when the prosthetic valve is implanted. Referring to <FIG>, the first end portions <NUM> can define openings <NUM>, and the second end portions <NUM> can define openings <NUM>. In certain embodiments, the struts <NUM> can be coupled to the frame <NUM> by sutures, loops, fasteners, or other securing means extending through the openings <NUM> and <NUM>. The struts <NUM> can also be coupled to the frame <NUM> by adhesive, or heat bonding such as by welding. In yet other embodiments, the struts <NUM> can be integrally formed with the frame <NUM>. As used herein, the terms "unitary construction" and "integrally formed" refer to a construction that does not include any stitches, sutures, welds or bonds, fasteners, or other means for securing separately formed pieces of material to each other.

Referring again to <FIG>, the trough-to-peak radial distance r<NUM> between the trough <NUM> and the crest <NUM>, and the trough-to-peak radial distance r<NUM> between the trough <NUM> and the crest <NUM>, can each be configured such that when the prosthetic valve <NUM> is crimped to the collapsed configuration, the main body <NUM> of each strut straightens and lengthens along with the frame <NUM> and lies flat against the exterior of the frame <NUM>. When the prosthetic valve <NUM> is expanded to its functional size, each of the struts <NUM> can assume the undulating shape illustrated in <FIG>.

The struts <NUM> can be formed from any of various self-expandable materials such as Nitinol, or plastically-expandable materials such as stainless steel or cobalt chromium alloys. In other embodiments, the struts <NUM> can comprise polymeric materials. In certain embodiments, the struts <NUM> can be shape-set into the configuration shown in <FIG>.

In other embodiments, the struts <NUM> can extend between any two rows of struts of the inner frame <NUM>, and can comprise any number of crests and troughs, including a single crest (e.g., such that the struts <NUM> are bow-shaped), or more than two crests. The struts <NUM> also need not be coupled to each apex 24A of the inner frame <NUM>, but can be coupled to every other apex 24A, or to select apices 24A with a selected angular spacing (e.g., three struts <NUM> circumferentially spaced apart around the frame <NUM> by <NUM>°). In yet other embodiments, different configurations of struts <NUM> of having varying shapes and/or lengths can be coupled to the frame <NUM>, depending upon the particular application.

When implanted in the native mitral valve, the prosthetic valve <NUM> can be disposed at least partially in the left ventricle. The struts <NUM> and/or the barbs <NUM> can engage the surrounding tissue and hold the prosthetic valve in place. In certain embodiments, the prosthetic valve can be positioned in the mitral annulus such that the mitral annulus is received in the troughs defined by the second apices <NUM> of the struts <NUM>. In this manner, the tissue of the annulus and/or the mitral valve leaflets can be received or engaged between the apices <NUM> and <NUM>, and/or engaged by the barbs <NUM>.

<FIG> illustrate another embodiment of a prosthetic heart valve <NUM> including an inner frame configured as the frame <NUM> of <FIG>, and including the leaflets <NUM>. The prosthetic valve <NUM> can further comprise a plurality of first strut members <NUM> disposed around the exterior of the frame <NUM> adjacent or closer to the outflow end <NUM> of the frame <NUM>, and a plurality of second strut members <NUM> disposed around the exterior of the frame <NUM> adjacent or closer to the inflow end <NUM> of the frame <NUM>. <FIG> illustrates the first strut members <NUM> in greater detail. The strut members <NUM> can comprise a main body <NUM> having a first or outflow end portion <NUM> and a second or inflow end portion <NUM>. The first end portion <NUM> can comprise an opening <NUM>, and the second end portion <NUM> can comprise an opening <NUM>. The openings <NUM> and <NUM> can facilitate attachment of the strut members <NUM> to the frame <NUM> by, for example, suturing. The first struts <NUM> can comprise a tissue-engaging member configured as a barb <NUM> coupled to the main body <NUM> and offset circumferentially from the main body. In certain embodiments, the main bodies of the struts <NUM> can comprise a reduced width portion adjacent the barbs <NUM>, which can facilitate bending of the struts <NUM> at the reduced width portion. In the illustrated embodiment, the first strut members <NUM> can extend from the outflow apices 24B of the fifth row V of struts <NUM> (<FIG>) of the frame <NUM> to the junction between the third rung III and the fourth rung IV of struts <NUM>. The struts <NUM> can have a length configured such that when the prosthetic valve <NUM> is in the expanded configuration, the struts <NUM> bow outwardly from the frame <NUM> as shown, and can lie flat against the frame <NUM> when the prosthetic valve is in the collapsed configuration. As the struts <NUM> curve outwardly from the frame <NUM>, the barbs <NUM> can form an angle with the struts <NUM>, and can extend outwardly or away from the struts <NUM>. In other embodiments, the barbs <NUM> can be received in openings defined in the main bodies of the struts <NUM>, and can extend outwardly from the struts (e.g., in the proximal direction) when the frame is expanded, similar to the barbs <NUM> described above.

Referring to <FIG>, each second strut member <NUM> can comprise a main body <NUM> having a first end portion <NUM> and a second end portion <NUM>. The first and second end portions <NUM> and <NUM> can comprise respective openings <NUM> (<FIG>) and <NUM> for attachment to the frame <NUM>, similar to the first struts <NUM> described above. In the illustrated embodiment, the second strut members <NUM> can extend between the fourth rung IV of struts <NUM> of the frame <NUM> and the inflow apices 24A of the first rung I struts (<FIG>) of the frame <NUM> such that that the struts <NUM> and <NUM> are spaced apart in the axial direction but at least partially overlap in the axial direction. The second struts <NUM> can have a length configured such that when the prosthetic valve <NUM> is in the expanded configuration, the struts <NUM> bow outwardly from the frame <NUM> as shown, and lie flat against the frame <NUM> when the prosthetic valve is in the collapsed configuration. The second struts <NUM> can also comprise a central portion <NUM> with a reduced width dimension. In certain embodiments, the struts <NUM> can be induced to bend about the central portion <NUM> such that the central portion <NUM> defines an apex of the curved struts in the expanded configuration, as shown in <FIG>. In other embodiments, the reduced width portion can be located elsewhere along the length of the strut <NUM> in order to induce flexing about other points. In yet other embodiments, the struts <NUM> can also comprise tissue-engaging members, such as any of the tissue-engaging member embodiments described herein. In other embodiments, the struts <NUM> and <NUM> need not overlap in the axial direction.

In the illustrated embodiment, the first struts <NUM> and the second struts <NUM> can be arranged alternatingly around the circumference of the frame <NUM> such that, moving in a circumferential direction around the frame <NUM>, each strut member <NUM> is disposed between two struts <NUM> and vice versa. In other embodiments, the struts <NUM> and <NUM> can be arranged in any pattern, and can have any length. The struts <NUM> and <NUM> can also extend between any two rows of struts I-V of the inner frame <NUM>. Certain embodiments may also include more first struts <NUM> than second struts <NUM>, or vice versa, with any angular spacing, depending upon the particular application.

The struts <NUM> and <NUM> can comprise any biocompatible self-expandable or plastically expandable materials, as described above. In certain embodiments, the struts <NUM> and/or <NUM> can be sutured to the frame <NUM>, but may also be adhered, welded, etc., or any combination thereof. The struts <NUM> and/or the struts <NUM> may also be integrally formed with the frame <NUM>.

When implanted in the mitral valve, the prosthetic valve <NUM> can be positioned such that the mitral annulus is disposed at about the level of the fourth row IV of struts of the inner frame <NUM> (see <FIG>). In other words, the mitral annulus can be disposed between, and/or engaged by, the second end portions <NUM> of the struts <NUM> and the first end portions <NUM> of the struts <NUM>. The barbs <NUM> can also engage the native leaflets of the mitral valve (e.g., the ventricular surfaces of the leaflets) and/or the surrounding tissue of the valve annulus to hold the prosthetic valve <NUM> in place.

<FIG> illustrate another embodiment of a prosthetic heart valve <NUM> including the frame <NUM> of <FIG> and the leaflets <NUM>. In the illustrated embodiment, the prosthetic heart valve <NUM> is configured for implantation in the native aortic valve (e.g., to treat aortic insufficiency), but can be implanted within the other native heart valves in other embodiments. Thus, with reference to <FIG>, the prosthetic valve <NUM> is shown in an orientation suitable for implantation in the aortic valve in which the lower portion of the prosthetic valve <NUM> in the figure is configured as the inflow end <NUM> and the upper portion of the valve is configured as the outflow end <NUM>.

The prosthetic valve <NUM> can further comprise a plurality of first strut members <NUM> and a plurality of second strut members <NUM> disposed around and coupled to the exterior of the frame <NUM>. <FIG> illustrate a representative embodiment of a first strut member <NUM> in greater detail. The strut member <NUM> can comprise a main body <NUM> having a first end portion <NUM> and a second end portion <NUM>. The first end portion <NUM> can comprise an opening <NUM>, and the second end portion <NUM> can comprise an opening <NUM>. The openings <NUM> and <NUM> can facilitate attachment of the strut members <NUM> to the frame <NUM> by, for example, suturing. The first strut <NUM> can also comprise a tissue-engaging member <NUM> having a base portion <NUM> coupled to the main body <NUM> and a sharp or pointed free end portion <NUM>. In the illustrated embodiment, the base portion <NUM> of the tissue-engaging member <NUM> is coupled to the main body <NUM> in an opening <NUM> defined in the main body. The tissue-engaging member <NUM> is configured such that the pointed free end portion <NUM> extends radially outwardly from the opening <NUM>, and is angled in the direction of the outflow end <NUM> of the prosthetic valve when the prosthetic valve is in the expanded configuration.

The second struts <NUM> can be configured similarly to the first struts <NUM>, and can include first end portions <NUM>, second end portions <NUM>, and tissue-engaging members <NUM> (see.

The tissue-engaging members <NUM> can comprise base portions <NUM> coupled to the struts <NUM> and free end portions <NUM>, and can extend radially outwardly from the struts <NUM> in the direction of the inflow end <NUM> of the prosthetic valve when the prosthetic valve is in the expanded configuration.

In the illustrated embodiment, the first strut members <NUM> can extend between the first row I (<FIG>) of struts <NUM> of the frame <NUM> and the second row II of struts <NUM> (e.g., the junction between the second row II and the third row III). The struts <NUM> can extend between the second row II of struts <NUM> (<FIG>) (e.g., the junction between the second row II and the third row III) of the frame <NUM> and the fourth rung IV of struts <NUM>. The struts <NUM> and the struts <NUM> can have respective lengths configured such that when the prosthetic valve <NUM> is in the expanded configuration, the struts <NUM> and the struts <NUM> bow radially outwardly from the frame <NUM>. In the expanded state, the tissue-engaging members <NUM> can extend radially away from the struts <NUM> in a direction toward the outflow end <NUM>, and at an angle to the struts <NUM>. The tissue-engaging members <NUM> of the struts <NUM> can extend radially away from the struts <NUM> in a direction toward the inflow end <NUM>, and at an angle to the struts <NUM>. The struts <NUM> and <NUM> can be coupled to the frame <NUM> by, for example, sutures extending through the respective openings in the end portions of the struts, or by any other attachment method.

<FIG> illustrate expansion of the prosthetic valve <NUM> from the collapsed configuration in <FIG>, through a partially expanded state in <FIG>, to a fully expanded state in <FIG>. As shown in <FIG>, the struts <NUM> and the struts <NUM> can be configured to lie flat against the frame <NUM> when the prosthetic valve <NUM> is in the collapsed configuration. In the expanded configuration, the struts <NUM> and <NUM> can be configured to expand into the Valsava sinuses of the aortic root to prevent the prosthetic valve from becoming dislodged during valve operation. The tissue-engaging members <NUM> and <NUM> can also engage the tissue of the aortic root. By expanding into the aortic root and engaging the surrounding tissue, the struts <NUM> and <NUM> can be especially advantageous in treating aortic insufficiency in patients where there is not significant calcification of the native aortic valve against which to anchor a traditional transcatheter heart valve, and/or patients in which the aortic root is dilated.

In the illustrated embodiment, the first struts <NUM> and the second struts <NUM> can be paired with each other at the same circumferential location on the frame <NUM> (e.g., aligned with the outflow apices of the frame <NUM>). In other words, the second end portions <NUM> of the first struts <NUM> and the first end portions <NUM> of the second struts <NUM> can be aligned with each other, and can be coupled to the frame <NUM> at the same circumferential location on the frame <NUM>. In other embodiments, the struts <NUM> and the struts <NUM> can be circumferentially offset from each other around the frame <NUM>, and/or the number of struts <NUM> may differ from the number of struts <NUM>, depending upon the particular characteristics desired.

Referring to <FIG>, the prosthetic valve <NUM> can include a first annular skirt member <NUM> disposed around the frame <NUM> and coupled to the first struts <NUM>. With reference to <FIG>, in some embodiments the skirt <NUM> can be disposed on and/or coupled to the exterior surfaces of the struts <NUM> between, for example, the second end portions <NUM> and the bases <NUM> (<FIG>) of the tissue-engaging members <NUM>. In this manner, the skirt <NUM> can extend radially outward from the frame <NUM> and at an angle to the frame <NUM> such that an outer surface <NUM> of the skirt <NUM> is oriented proximally or in the downstream direction toward the outflow end <NUM> of the prosthetic valve when the prosthetic valve is in the expanded configuration. For example, in some embodiments the skirt <NUM> can be oriented at an angle of <NUM>° to <NUM>°, <NUM>° to <NUM>°, or <NUM>° relative to the exterior surface of the frame <NUM>. When the frame is in the expanded configuration, a first circumferential edge <NUM> of the skirt <NUM> can be disposed against or adjacent the exterior of the frame <NUM>, and a second circumferential edge <NUM> can be disposed radially outward of the circumferential edge <NUM> (e.g., adjacent the apices of the struts <NUM>).

The prosthetic valve can further include a second annular skirt member <NUM> disposed around the frame <NUM> and coupled to the second struts <NUM>. The second skirt <NUM> can be disposed on and/or coupled to the exterior surfaces of the struts <NUM> between the bases <NUM> (<FIG>) of the tissue-engaging members <NUM> and the first end portions <NUM> of the second struts <NUM>. The skirt <NUM> can extend radially outward from the frame <NUM> and at an angle to the frame <NUM> such that an outer surface <NUM> of the skirt <NUM> is oriented distally or in the upstream direction toward the inflow end <NUM> of the prosthetic valve in the expanded configuration, and angled toward the surface <NUM> of the skirt <NUM>. For example, the skirt <NUM> can be oriented at substantially the same angle to the frame <NUM> as the skirt <NUM>, but in the opposite direction toward the inflow end <NUM>. The skirts <NUM> and <NUM> can help to seal against the surrounding tissue to reduce or prevent perivalvular leakage around the prosthetic valve. In other embodiments, the skirt <NUM> and/or the skirt <NUM> can extend over or cover the apices of the respective struts <NUM> and <NUM>. In yet other embodiments, the prosthetic heart valve <NUM> can comprise a sealing member such as a skirt that covers both sets of struts <NUM> and <NUM>, and which can be urged outwardly into a curved shape by the struts when the frame is expanded.

In the illustrated embodiment, the skirts <NUM> and <NUM> can be configured as strips of material. The skirts <NUM> and <NUM> can comprise a woven fabric, a non-woven fabric such as a knitted fabric or felt material, and/or a polymeric film or substrate. In some embodiments, the skirt <NUM> can be configured different from the skirt <NUM>, and/or can comprise different materials. The skirts may also be different sizes and/or shapes, depending upon the particular requirements of the system. A single sealing member can also be positioned between the struts <NUM> and <NUM> and attached to the struts <NUM>, <NUM> such that the sealing member folds about its circumferential midline as the struts <NUM> and <NUM> move into the curved shape.

In some embodiments, the prosthetic valve embodiments described herein can be used in combination with any of a variety of conduits or conduit grafts, such as endovascular grafts, stent grafts, etc., for example, to repair a blood vessel downstream of the prosthetic valve. A representative embodiment of a prosthetic device comprising a prosthetic valve <NUM> and a conduit <NUM> is illustrated in <FIG>. In particular embodiments, the prosthetic valve <NUM> is configured to be implanted within or adjacent the native aortic valve and the conduit <NUM> is configured to be implanted in the ascending aorta.

The conduit <NUM> can comprise a tubular main body <NUM> having a first (e.g., inflow) end portion <NUM> and a second (e.g., outflow) end portion <NUM>. In the embodiment of <FIG>, the main body <NUM> can comprise a stent frame <NUM> and a tubular textile covering <NUM>. In certain embodiments, the stent frame and, thus, the main body <NUM>, can be movable between a collapsed delivery configuration and an expanded functional configuration. In the expanded state, the main body <NUM> can have a diameter D<NUM>. The second end portion <NUM> can comprise a stent frame <NUM>, which can have a diameter D<NUM> that is larger than the diameter D<NUM> of the main body <NUM> when the conduit is in the expanded state to aid in anchoring the conduit in a blood vessel, as further described below.

The first end portion <NUM> can be configured to interface with the outflow end <NUM> of the prosthetic valve <NUM> such that the prosthetic valve and the conduit are in fluid communication with one another. For example, in certain embodiments, the outflow end <NUM> of the prosthetic valve <NUM> can be coupled to the first end portion <NUM> of the conduit <NUM> by, for example, suturing, loops or extension portions extending through the struts of the prosthetic valve <NUM>, by any of various mechanical couplings such as locking rings, or by any other coupling means. In certain embodiments, the prosthetic valve <NUM> can be at least partially received within the lumen of the conduit <NUM>. The conduit <NUM> can comprise a sealing feature or sealing member generally indicated at <NUM>. The sealing feature <NUM> can be disposed circumferentially around the main body <NUM>, although only a portion of the sealing feature <NUM> is shown in <FIG>. In certain embodiments, the sealing member <NUM> can be positioned downstream of the prosthetic valve <NUM>. The sealing feature <NUM> can be configured to form a seal with the walls of a vessel into which the conduit <NUM> is implanted (e.g., the aortic root or the ascending aorta). The sealing feature <NUM> can comprise, for example, voluminous fabrics such as velour, one or more fabric skirts, a stent or frame (e.g., comprising a fabric covering), or combinations thereof.

<FIG> illustrates another embodiment of a conduit <NUM> that can be used in combination with the prosthetic valves described herein, such as the prosthetic valve <NUM>. The main body <NUM> can comprise corrugations or ridges <NUM> that increase the flexibility of the conduit and allow the conduit to increase or decrease in length. The conduit <NUM> can also comprise a sealing feature <NUM> at or near the inflow end <NUM> of the conduit. The sealing feature <NUM> can be configured similarly to any of the sealing features described above with reference to <FIG>. The outflow end <NUM> of the conduit can also comprise a frame or portion <NUM> having a diameter greater than the diameter of the main body of the conduit to facilitate anchoring the outflow end <NUM> in a body lumen. In certain embodiments, the outflow portion <NUM> can comprise a sealing feature similar to the seal <NUM> in place of, or in addition to, the frame <NUM>.

<FIG> illustrates the prosthetic valve <NUM> and the conduit <NUM> coupled together and implanted within the ascending aorta <NUM> to isolate and bypass an aneurysm <NUM> of the ascending aorta. In the illustrated configuration, the struts <NUM> and <NUM> (<FIG>) can bow, curve, or extend radially outwardly from the frame <NUM> to anchor the prosthetic valve <NUM> in the aortic root <NUM>. In certain embodiments, the prosthetic valve <NUM> can be disposed in the aortic annulus <NUM> such that the aortic annulus is positioned between the skirts <NUM> and <NUM>. In certain embodiments, the prosthetic valve <NUM> can press the native leaflets toward or against the walls of the aortic root <NUM>, such as the walls of the Valsava sinuses. Meanwhile, the frame <NUM> of the conduit <NUM> can anchor the outflow end <NUM> of the conduit in the aortic arch <NUM> at a location, for example, proximate the brachiocephalic artery <NUM>. The sealing feature <NUM> can form a seal between the main body <NUM> of the conduit <NUM> and the walls of the aorta to isolate the aneurysm <NUM>. The stent frame <NUM> at the proximal end of the conduit <NUM> can also form a seal with the aortic wall to isolate the aneurysm <NUM>. In certain embodiments, the outflow end portion <NUM> can include a sealing feature similar to the sealing feature <NUM>.

In certain embodiments, a portion of the blood flowing through the prosthetic valve <NUM> can flow through the conduit <NUM> to the aortic arch, and a portion of the blood can flow into the aortic root <NUM> (e.g., through openings between the frame struts of the prosthetic valve or openings along the first end portion <NUM> of the conduit) to perfuse the coronary arteries <NUM> and <NUM>. In other embodiments, the conduit <NUM> and/or the prosthetic valve <NUM> can include conduits or stents (not shown) that extend at least partially into the coronary arteries <NUM> and <NUM>, and/or that are anastomosed to the coronary arteries. In yet other embodiments, the sealing feature <NUM> can be configured as a stent frame similar to the frame <NUM>, and/or the frame <NUM> can be configured as a voluminous fabric and/or as a skirt.

<FIG> illustrate another embodiment of a prosthetic device comprising a prosthetic valve <NUM> coupled to a conduit <NUM>, which can be configured for implantation within the native aortic valve and the ascending aorta. The conduit <NUM> can comprise a tubular main body <NUM> having a first (e.g., inflow) end portion <NUM> and a second (e.g., outflow) end portion <NUM>. The main body <NUM> can comprise a stent frame <NUM> including one or more strut members <NUM> curved so as to comprise a plurality of axially spaced-apart peaks <NUM> and valleys <NUM> in the manner of a sine wave. The valleys <NUM> can be located at an inflow end <NUM> of the frame <NUM>, and the peaks <NUM> can be located at an outflow end <NUM> of the frame. In certain embodiments, the stent frame <NUM> and, thus, the main body <NUM>, can be movable between a collapsed delivery configuration and an expanded, functional configuration, similar to the prosthetic valve <NUM>. The stent frame <NUM> can comprise any of the self-expanding or plastically-expandable materials described herein.

The conduit <NUM> can further include one or more textile coverings <NUM> disposed around the frame <NUM> (e.g., on the inside and/or the outside of the frame). The conduit <NUM> illustrated in <FIG> is shorter than the conduit <NUM> of <FIG>, but can have any suitable length and/or curvature depending upon the particular body lumen and/or species into which the device is intended for implantation. For example, multiple conduits <NUM> can be coupled to each other serially such that they define a common lumen in order to provide an implant with a specified length.

The conduit <NUM> can include a first sealing feature or sealing member configured as a skirt <NUM> disposed circumferentially around the inflow portion <NUM>. The conduit can further include a second sealing feature or sealing member configured as a skirt <NUM> disposed circumferentially around the outflow end portion <NUM>. When implanted in the aorta, the skirts <NUM> and <NUM> can be configured to form a seal with the walls of the aorta to isolate and bypass a portion of the aorta, such as an aneurysm similar to the aneurysm shown in <FIG>. In some embodiments, the skirts <NUM> and <NUM> may be integrally formed with the covering <NUM>, or may be separately formed and secured to the covering <NUM> (e.g., by stitching or suturing). For example, in the illustrated embodiment the skirts <NUM> and <NUM> are sutured to the covering <NUM> along one circumferential edge, and are free at the other circumferential edge so that the skirts can extend radially outwardly from the conduit <NUM> to engage and form a seal with the walls of the aorta. In certain embodiments, the covering <NUM> and the skirts <NUM>, <NUM> can comprise a woven fabric, such as a woven PET fabric.

The conduit <NUM> can be coupled to the prosthetic valve <NUM> by any of various coupling means including sutures, extensions looped through the frame struts of the prosthetic valve <NUM>, etc. In certain embodiments, the conduit <NUM> can be flexibly coupled to the prosthetic valve <NUM>. For example, in the illustrated embodiment, the inflow end <NUM> of the frame <NUM> can be axially spaced apart in the downstream direction from the outflow end <NUM> of the frame <NUM> of the prosthetic valve <NUM> such that the two frames are separated by a distance D. The covering <NUM> can extend across the distance D between the frame <NUM> and the frame <NUM>. This can allow the frames <NUM> and <NUM> to be crimped and/or expanded independently of each other, as illustrated in <FIG>.

In certain embodiments, the configuration of the frame <NUM> illustrated in <FIG> can be particularly suited for manufacture from Nitinol or another self-expanding material, although plastically-expandable materials may also be used. <FIG> illustrates the prosthetic device <NUM> and the conduit <NUM> crimped on the balloon <NUM> at the distal end of the balloon catheter <NUM> of the delivery apparatus of <FIG>. In embodiments in which the conduit <NUM> is made from a self-expandable material, the conduit <NUM> can be encapsulated in a polymeric covering or capsule <NUM> that retains the conduit <NUM> in the collapsed delivery configuration. When the device is deployed, the capsule <NUM> can be opened, withdrawn, or removed from over the conduit <NUM>, allowing the conduit <NUM> to expand to its functional size.

<FIG> illustrates another embodiment of a prosthetic device including a conduit <NUM> coupled to a prosthetic valve <NUM>. The conduit <NUM> can comprise a tubular main body having a first (e.g., inflow) end portion <NUM> in fluid communication with the outflow end <NUM> of the prosthetic valve <NUM>, and a second (e.g., outflow) end portion <NUM> opposite the inflow end portion <NUM>. The conduit <NUM> can include a frame <NUM> comprising a plurality of angled, interconnected strut members <NUM>, and having an inflow end <NUM> and an outflow end <NUM>. In the illustrated example, the inflow end <NUM> of the frame <NUM> can be axially spaced apart from the outflow end <NUM> of the frame <NUM> of the prosthetic valve <NUM> in a downstream direction, similar to the conduit <NUM> above.

A covering <NUM> can extend around the outside of the frame <NUM>, and between the inflow end <NUM> of the frame <NUM> and the outflow end <NUM> of the frame <NUM>. In certain embodiments, the covering <NUM> can be sutured to the strut members <NUM> of the frame <NUM> of the prosthetic valve <NUM> to couple the conduit <NUM> and the prosthetic valve <NUM> together. In other embodiments, the covering <NUM> can comprise loops (e.g., fabric or suture loops) or other securing means to couple the conduit <NUM> to the frame <NUM>. Sealing features configured as skirts <NUM> and <NUM> can extend circumferentially around the conduit <NUM>. The skirt <NUM> can be located at the inflow end <NUM> of the conduit <NUM> (e.g., adjacent the inflow end <NUM> of the frame <NUM>), and the skirt <NUM> can be located at the outflow end <NUM> of the frame <NUM>. In the illustrated configuration, the skirts <NUM> and <NUM> are sutured to the covering <NUM> along one circumferential edge, and are free at the other circumferential edge so that the skirts can extend radially outwardly from the conduit <NUM> to engage and form a seal with the walls of the aorta.

The configuration of the frame <NUM> illustrated in <FIG> can be particularly suited for manufacture from plastically-expandable materials such as cobalt-chromium or stainless steel, although self-expanding materials may also be used. In embodiments where the frame <NUM> is made from a plastically-expandable material, the conduit <NUM> can be expanded to its functional size by a balloon or another expansion device. For example, in certain configurations, the prosthetic valve <NUM> and the conduit <NUM> can be crimped over the balloon <NUM> of the balloon catheter <NUM> of <FIG>, and the balloon <NUM> may be used to expand both the prosthetic valve <NUM> and the conduit <NUM>. In embodiments where the frame <NUM> comprises a plastically-expandable material, the prosthetic valve <NUM> and the conduit <NUM> can be enclosed in a loader or container similar to the loader <NUM> of <FIG> for insertion into the body through an introducer sheath.

<FIG> illustrates another embodiment of a prosthetic device including a prosthetic heart valve configured as the prosthetic heart valve <NUM>, and a radially expandable and collapsible conduit <NUM> comprising a plurality of frames <NUM> arranged coaxially with each other, and with the prosthetic valve <NUM>. In the illustrated embodiment, the conduit <NUM> comprises two frames 1402A and 1402B. However, the conduit <NUM> can comprise any number of frames <NUM>, such as a single frame, or more than two frames, depending upon the particular length desired.

<FIG> illustrates a representative frame <NUM> in greater detail. The frame <NUM> can have a cylindrical shape, and can comprise a plurality of interconnected, angled strut members <NUM>. The frame <NUM> can have an inflow end <NUM> and an outflow end <NUM>. The struts <NUM> can define a plurality of apices <NUM> at the inflow end <NUM> where respective strut members are joined, and can define a plurality of apices <NUM> at the outflow end <NUM> where respective struts are joined. The frame <NUM> can further comprise a plurality of strut members <NUM> arrayed circumferentially around the inflow end <NUM> of the frame, and a plurality of strut members <NUM> arrayed circumferentially around the outflow end <NUM> of the frame. In the illustrated embodiment, the longitudinal axes <NUM> of the strut members <NUM> and <NUM> are oriented parallel to the longitudinal axis <NUM> of the frame <NUM>. The struts <NUM> can be coupled to the apices <NUM> at one end, can extend axially along the frame <NUM> across one or more frame openings <NUM> defined by the struts <NUM>, and can be coupled to strut junctions <NUM> at the other end. The struts <NUM> can be coupled to the apices <NUM> at one end, can extend axially along the frame <NUM> across one or more frame openings <NUM>, and can be coupled to strut junctions <NUM> at the opposite end. In certain embodiments, the struts <NUM> and <NUM> can be integrally formed with the frame <NUM> (e.g., by laser cutting the frame <NUM> from a tube), or can be separately formed and secured to the frame <NUM>.

<FIG> illustrates the frame <NUM> in the collapsed configuration. The struts <NUM> and <NUM> can have lengths configured such that when the frame <NUM> is in the collapsed configuration, the struts <NUM> and <NUM> are straight, or substantially straight, and can lie in close proximity to the struts <NUM>. When expanded, the frame <NUM> can shorten, which can cause the struts <NUM> and <NUM> to bow, arch, or curve radially outwardly from the frame <NUM>, as illustrated in <FIG>.

In other embodiments, the struts <NUM>, the struts <NUM>, or combinations thereof can be oriented at an angle to the longitudinal axis <NUM> of the frame. For example, one or both sets of struts <NUM> and/or <NUM> can be oriented such that the struts extend circumferentially around the frame <NUM> (e.g., at a <NUM>° angle to the longitudinal axis <NUM>). In certain embodiments, the orientation of the struts <NUM> and/or the orientation struts <NUM> can vary or alternate on a strut-by-strut basis around the circumference of the frame. For example, a strut <NUM> can be oriented longitudinally, followed by a strut <NUM> oriented circumferentially, followed by a strut <NUM> oriented longitudinally, etc. Any of the struts <NUM> and/or <NUM> can also extend across the openings <NUM> diagonally, or at any angle. The frame <NUM> may also include more or fewer struts <NUM> and/or <NUM> than shown. The frame <NUM> can also include additional rows of struts configured to bow or curve radially outwardly as the frame foreshortens during expansion. For example, each row of frame openings <NUM> can comprise corresponding struts configured to curve radially outwardly in the expanded configuration. Any of the frame configurations described herein can also comprise struts oriented at different angles and configured to bend, bow, or expand radially outwardly from the frame.

Returning to <FIG>, the frame <NUM> can include an exterior covering schematically illustrated at <NUM>. The covering <NUM> can extend over the struts <NUM> and <NUM>. When the frame <NUM> is expanded, the struts <NUM>, <NUM>, and the covering <NUM>, can contact the walls of the aorta to form a seal, and can aid in holding the conduit in place. In certain embodiments, the covering <NUM> can comprise a woven or non-woven fabric, a polymeric coating applied by electrospinning or dip-coating, or any other suitable material. Where a conduit <NUM> includes multiple frame units <NUM>, the covering <NUM> can be sized to cover all of the frames <NUM>, or each frame can comprise a separate covering, depending upon the particular characteristics desired.

The frame <NUM> can also include a tubular inner covering schematically illustrated at <NUM>. The covering <NUM> can be configured to promote laminar blood flow through the frame <NUM>, and can comprise a woven or non-woven fabric, an electrospun or dip-coated polymeric layer, etc. Where a conduit <NUM> includes multiple frame units <NUM>, the covering <NUM> can be sized to extend between all of the frames <NUM>, or each frame can comprise a separate covering.

Returning to <FIG>, the prosthetic valve <NUM> and the first frame 1402A can be coupled or interconnected by a flexible coupling means, such as a fabric or flexible polymer layer generally indicated at 1432A. The frames 1402A and 1402B can be coupled together by a similar coupling 1432B. In certain embodiments, the couplings 1432A and 1432B can be portions of the exterior covering <NUM> and/or the interior covering <NUM> that extend between the frames 1402A and 1402B, and/or between the frame 1402A and the prosthetic valve <NUM>. In other embodiments, the coupling 1432A and/or the coupling 1432B can be a separate piece of material.

The flexible couplings 1432A and 1432B can allow the prosthetic valve <NUM>, the frame 1402A, and the frame 1402B to be expanded and/or collapsed independently of one another, similar to the embodiment of <FIG>, and <FIG> above. For example, <FIG> illustrate implantation of a prosthetic device similar to the device of <FIG> in a porcine aorta <NUM> during a porcine animal trial. The prosthetic device of <FIG> includes a prosthetic valve <NUM> and a conduit <NUM> including a single frame <NUM> sized for implantation in a porcine aorta. In other embodiments, including embodiments for use in human patients, the conduit may include more than one frame.

In <FIG>, the prosthetic valve <NUM> and the frame <NUM> are shown collapsed on a balloon catheter <NUM>, with the prosthetic valve <NUM> located in the aortic annulus generally indicated at <NUM>, and the frame <NUM> located in the ascending aorta. <FIG> illustrates expansion of the prosthetic valve <NUM> with a balloon <NUM>. As the prosthetic valve <NUM> expands, the struts <NUM> and <NUM> (<FIG>) can curve radially outwardly from the frame <NUM> to anchor the prosthetic valve against the surrounding tissue. In the illustrated embodiment, inflation of the balloon <NUM> to expand the prosthetic valve <NUM> can also cause partial expansion of the inflow end portion of the frame <NUM>. <FIG> illustrates deflation of the balloon <NUM>, and proximal retraction of the balloon catheter <NUM> to position the balloon <NUM> within the frame <NUM>. <FIG> illustrates inflation of the balloon <NUM> a second time to expand the frame <NUM> in the ascending aorta. Expansion of the frame <NUM> can cause corresponding motion of the struts <NUM> and <NUM> into the curved shape. <FIG> illustrates the prosthetic valve <NUM> and the conduit <NUM> fully deployed. When fully deployed, the prosthetic valve <NUM> can regulate blood flow into the aorta from the left ventricle. Referring to <FIG>, a portion of the blood flow through the prosthetic valve <NUM> can flow through openings in the frame of the prosthetic valve to perfuse the coronary arteries <NUM>, and a portion of the blood flow can flow through the conduit <NUM> to bypass at least a portion of the ascending aorta. For conduits including more than one frame, the balloon <NUM> can be deflated, proximally or distally repositioned, and re-inflated to expand the frames of the prosthetic valve and/or of the conduit in any order.

In certain embodiments, the strut members configured to curve radially outwardly from the frame of any of the frame embodiments described herein can comprise mechanisms or means for inducing bending at select locations or regions along the lengths of the struts. For example, in certain embodiments the struts may comprise living hinges about which the struts can bend as the frame foreshortens. In certain embodiments, the struts can comprise areas of reduced thickness to induce bending at that location. In other embodiments the struts can comprise any of a variety of joints, hinges, or pivotable connections about which the struts can bend into the curved shape. Although the prosthetic heart valve frame embodiments described herein are presented in the context of plastically-expandable valves, it should be understood that the disclosed frame embodiments can also be implemented with various other types of prosthetic heart valves such as self-expandable valves and mechanically-expandable valves. Examples of self-expandable prosthetic heart valves can be found in <CIT>, <CIT>, and <CIT>. Examples of mechanically-expandable prosthetic heart valves can be found in <CIT> and <CIT>. Additional examples of plastically-expandable prosthetic heart valves can be found in <CIT>, and <CIT>. The frame embodiments described herein can also be used in valves intended for implantation at any of the native annuluses of the heart (e.g., the aortic, pulmonary, mitral, and tricuspid annuluses), and can be configured for implantation within existing prosthetics valves (so called "valve-in-valve" procedures). The frame embodiments can also be used in combination with other types of devices implantable within other body lumens outside of the heart, or heart valves that are implantable within the heart at locations other than the native valves, such as trans-atrial or trans-ventricle septum valves, stent grafts, etc..

For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.

As used in this application and in the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "includes" means "comprises. " Further, the terms "coupled" and "associated" generally mean electrically, electromagnetically, and/or physically (e.g., mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

In the context of the present application, the terms "lower" and "upper" are used interchangeably with the terms "inflow" and "outflow", respectively. Thus, for example, the prosthetic valve illustrated in <FIG> is shown in the orientation associated with implantation in the mitral valve, and so the upper end of the valve is its inflow end and the lower end of the valve is its outflow end.

As used herein, the term "proximal" refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term "distal" refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device toward the user, while distal motion of the device is motion of the device away from the user. The terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

Claim 1:
A prosthetic heart valve (<NUM>) that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, comprising:
an annular inner frame (<NUM>) comprising a plurality of angled first strut members (<NUM>), the inner frame (<NUM>) being configured to foreshorten from a first length (L<NUM>) corresponding to the collapsed configuration to a second length (L<NUM>) corresponding to the expanded configuration when the prosthetic heart valve (<NUM>) is expanded to the expanded configuration;
a leaflet structure situated at least partially within the inner frame (<NUM>); and
an outer frame (<NUM>) disposed radially outward of the inner frame (<NUM>) and coupled to the inner frame (<NUM>), the outer frame (<NUM>) being configured to collapse with the inner frame (<NUM>) to the collapsed configuration and expand with the inner frame (<NUM>) to the expanded configuration, the outer frame (<NUM>) comprising a plurality of second strut members (<NUM>);
wherein at least respective portions of the second strut members (<NUM>) are configured to bend radially outwardly into a curved shape as the inner frame (<NUM>) and the outer frame (<NUM>) move from the collapsed configuration to the expanded configuration;
wherein each of the second strut members (<NUM>) comprises first (<NUM>) and second end portions (<NUM>); and
wherein the first (<NUM>) and second end portions (<NUM>) of each of the second strut members (<NUM>) are coupled to the inner frame (<NUM>) such that the first (<NUM>) and second end portions (<NUM>) move toward each other as the outer frame (<NUM>) expands to bend the second strut members (<NUM>) into the curved shape.