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. Because of the drawbacks associated with conventional open-heart surgery, percutaneous and minimally-invasive surgical approaches are garnering intense attention. In one technique, a prosthetic valve is configured to be implanted in a much less invasive procedure by way of catheterization. For example, collapsible transcatheter prosthetic heart valves can be crimped to a compressed state and percutaneously introduced in the compressed state on a catheter and expanded to a functional size at the desired position by balloon inflation or by utilization of a self-expanding frame or stent.

A prosthetic valve for use in such a procedure can include a radially collapsible and expandable frame to which leaflets of the prosthetic valve can be coupled. For example, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT> describe exemplary collapsible and expandable transcatheter prosthetic heart valves.

The prosthetic valve can be percutaneously introduced in a collapsed configuration on a catheter and expanded in the desired position by balloon inflation, mechanical expansion, or by utilization of a self-expanding frame or stent. A challenge in catheter-implanted prosthetic valves is control of perivalvular leakage around the valve, which can occur for a period of time following initial implantation. An additional challenge includes the process of crimping such a prosthetic valve to a profile suitable for percutaneous delivery to a patient.

<CIT> describes an implantable prosthetic valve comprising an expandable frame, a leaflet structure and an outer skirt. <CIT> describes a prosthetic heart valve including a collapsible and expandable stent, a cuff, leaflets and a sealing structure.

Embodiments not covered by the claims are illustrative. Embodiments of a radially collapsible and expandable prosthetic valve are disclosed herein that include an improved outer sealing member for reducing perivalvular leakage, as well as related methods and apparatuses including such prosthetic valves. In several embodiments, the disclosed prosthetic valves are configured as replacement heart valves for implantation into a subject.

In one representative embodiment, an implantable prosthetic valve can comprise an annular frame, a leaflet structure positioned within the frame and secured thereto, an annular sealing member positioned around an outer surface of the frame, and an outer skirt positioned around an outer surface of the sealing member and secured to the frame. The annular frame can comprise an inflow end and an outflow end and can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The annular sealing member can have a periodic, undulating shape.

In some embodiments, the sealing member can be secured directly to the frame.

In some embodiments, the sealing member can be secured to an inner surface of the outer skirt.

In some embodiments, the sealing member can have a zig-zag shape.

In some embodiments, the sealing member can comprise a plurality of first angled portions having a first orientation with respect to the frame and a plurality of second angled portions having a second orientation with respect to the frame. Each first angled portion can be connected to a second angled portion at an apex such that there is an angle between each first angled portion and a connected second angled portion.

In some embodiments, at least one of the apices can have a relatively pointed edge.

In some embodiments, at least one of the apices can have a rounded edge.

In some embodiments, the angle can be less than <NUM> degrees.

In some embodiments, the angle can be greater than <NUM> degrees.

In some embodiments, the angled can be <NUM> degrees.

In some embodiments, the outer skirt can have a plurality of openings.

In some embodiments, the openings can be axially aligned with the apices.

In another representative embodiment, an implantable prosthetic valve can comprise an annular frame, a leaflet structure positioned within the frame and secured thereto, an outer skirt positioned around an outer surface of the frame and secured thereto, and an annular sealing member positioned around an outer surface of the outer skirt and secured thereto. The annular frame can comprise an inflow end and an outflow end and can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration.

In some embodiments, the angled can be greater than <NUM> degrees.

In another representative embodiment, an implantable prosthetic valve can comprise an annular frame, a leaflet structure positioned within the frame and secured thereto, and an annular sealing member positioned around and conforming to an outer surface of the frame. The annular frame can comprise an inflow end and an outflow end and can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The annular sealing member can have a plurality of openings.

In some embodiments, the sealing member can comprise a plurality of circumferentially extending rows of openings.

In some embodiments, the sealing member can comprise a first row of openings and a second row of openings that is axially offset from the first row of openings.

In some embodiments, at least one of the openings can have a hexagonal shape.

In some embodiments, at least one of the openings can have a diamond shape.

In another representative embodiment, an implantable prosthetic valve can comprise an annular frame, a leaflet structure positioned within the frame and secured thereto, and an annular sealing member positioned around an outer surface of the frame. The annular frame can comprise an inflow end and an outflow end and can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The sealing member can comprise a plurality of first angled portions and a plurality of second angled portions such that the first and second angled portions form a plurality of v-shaped projections.

In some embodiments, the prosthetic valve can further comprise a plurality of straight first connecting portions extending between adjacent pairs of v-shaped projections at the bases of the first and second angled portions.

In some embodiments, the prosthetic valve can further comprise a plurality of straight second connecting portions extending between the first and second angled portions of each v-shaped projection.

In some embodiments, the second connecting portions can be axially offset from the first connecting portions.

In another representative embodiment, an implantable prosthetic valve can comprise an annular frame, a leaflet structure position3ed within the frame and secured thereto, and an annular sealing member positioned around an outer surface of the frame. The annular frame can comprise an inflow end and an outflow end and can be radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration. The sealing member can have an undulating shape comprising three u-shaped sections, wherein each u-shaped section can circumscribe the frame through an angle of about <NUM> degrees.

In some embodiments, the leaflet structure can comprise three leaflets and the u-shaped sections can follow the shape of the inflow edges of the leaflets.

The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures. In a representative embodiment the implantable prosthetic valve comprises an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration; a leaflet structure positioned within the frame and secured thereto; an annular sealing member ; and an outer skirt, wherein the annular sealing member is positioned around an outer surface of the frame and has a periodic, undulating shape, and the outer skirt is positioned around an outer surface of the sealing member and secured to the frame.

<FIG> show various views of a prosthetic heart valve <NUM>, according to one embodiment. The illustrated prosthetic valve is adapted to be implanted in the native aortic annulus, although in other embodiments it can be adapted to be implanted in the other native annuluses of the heart (e.g., the pulmonary, mitral, and tricuspid valves). The prosthetic valve can also be adapted to be implanted in other tubular organs or passageways in the body. The prosthetic valve <NUM> can have four main components: a stent or frame <NUM>, a valvular structure <NUM>, an inner skirt <NUM>, and a perivalvular sealing means or sealing member. The prosthetic valve <NUM> can have an inflow end portion <NUM>, an intermediate portion <NUM>, and an outflow end portion <NUM>. In the illustrated embodiment, the perivalvular sealing means comprises an outer skirt <NUM> (which can also be referred to as an outer sealing member).

The valvular structure <NUM> can comprise three leaflets <NUM>, collectively forming a leaflet structure, which can be arranged to collapse in a tricuspid arrangement, as best shown in <FIG>. The lower edge of leaflet structure <NUM> desirably has an undulating, curved scalloped shape (suture line <NUM> shown in <FIG> tracks the scalloped shape of the leaflet structure). By forming the leaflets with this scalloped geometry, stresses on the leaflets are reduced, which in turn improves durability of the prosthetic valve. Moreover, by virtue of the scalloped shape, folds and ripples at the belly of each leaflet (the central region of each leaflet), which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the prosthetic valve. The leaflets <NUM> can be formed of pericardial tissue (e.g., bovine pericardial tissue), biocompatible synthetic materials, or various other suitable natural or synthetic materials as known in the art and described in <CIT>.

The bare frame <NUM> is shown in <FIG>. The frame <NUM> can be formed with a plurality of circumferentially spaced slots, or commissure windows, <NUM> (three in the illustrated embodiment) that are adapted to connect to the commissures of the valvular structure <NUM> to the frame, as described in greater detail below. The frame <NUM> can be made of any of various suitable plastically-expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nickel titanium alloy (NiTi), such as nitinol). When constructed of a plastically-expandable material, the frame <NUM> (and thus the prosthetic valve <NUM>) can be crimped to a radially collapsed configuration on a delivery catheter and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expandable material, the frame <NUM> (and thus the prosthetic valve <NUM>) can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by insertion into a sheath or equivalent mechanism of a delivery catheter. Once inside the body, the prosthetic valve can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional size.

Suitable plastically-expandable materials that can be used to form the frame <NUM> include, without limitation, stainless steel, a biocompatible, high-strength alloys (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloys), polymers, or combinations thereof. In particular embodiments, frame <NUM> is made of a nickel-cobalt-chromium-molybdenum alloy, such as MP35N® alloy (SPS Technologies, Jenkintown, Pennsylvania), which is equivalent to UNS R30035 alloy (covered by ASTM F562-<NUM>). MP35N® alloy/UNS R30035 alloy comprises <NUM>% nickel, <NUM>% cobalt, <NUM>% chromium, and <NUM>% molybdenum, by weight. When MP35N® alloy is used as the frame material, as compared to stainless steel, less material is needed to achieve the same or better performance in radial and crush force resistance, fatigue resistances, and corrosion resistance. Moreover, since less material is required, the crimped profile of the frame can be reduced, thereby providing a lower profile prosthetic valve assembly for percutaneous delivery to the treatment location in the body.

Referring to <FIG>, the frame <NUM> in the illustrated embodiment comprises a first, lower row I of angled struts <NUM> arranged end-to-end and extending circumferentially at the inflow end of the frame; a second row II of circumferentially extending, angled struts <NUM>; a third row III of circumferentially extending, angled struts <NUM>; a fourth row IV of circumferentially extending, angled struts <NUM>; and a fifth row V of circumferentially extending, angled struts <NUM> at the outflow end of the frame. A plurality of substantially straight axially extending struts <NUM> can be used to interconnect the struts <NUM> of the first row I with the struts <NUM> of the second row II. The fifth row V of angled struts <NUM> are connected to the fourth row IV of angled struts <NUM> by a plurality of axially extending window frame portions <NUM> (which define the commissure windows <NUM>) and a plurality of axially extending struts <NUM>. Each axial strut <NUM> and each frame portion <NUM> extends from a location defined by the convergence of the lower ends of two angled struts <NUM> to another location defined by the convergence of the upper ends of two angled struts <NUM>. <FIG>, <FIG> are enlarged views of the portions of the frame <NUM> identified by letters A, B, C, D, and E, respectively, in <FIG>.

Each commissure window frame portion <NUM> connects to a respective commissure of the leaflet structure <NUM>. As can be seen each frame portion <NUM> is secured at its upper and lower ends to the adjacent rows of struts to provide a robust configuration that enhances fatigue resistance under cyclic loading of the prosthetic valve compared to cantilevered struts for supporting the commissures of the leaflet structure. This configuration enables a reduction in the frame wall thickness to achieve a smaller crimped diameter of the prosthetic valve. In particular embodiments, the thickness T of the frame <NUM> (<FIG>) measured between the inner diameter and outer diameter is about <NUM> or less.

The struts and frame portions of the frame collectively define a plurality of open cells of the frame. At the inflow end of the frame <NUM>, struts <NUM>, struts <NUM>, and struts <NUM> define a lower row of cells defining openings <NUM>. The second, third, and fourth rows of struts <NUM>, <NUM>, and <NUM> define two intermediate rows of cells defining openings <NUM>. The fourth and fifth rows of struts <NUM> and <NUM>, along with frame portions <NUM> and struts <NUM>, define an upper row of cells defining openings <NUM>. The openings <NUM> are relatively large and are sized to allow portions of the leaflet structure <NUM> to protrude, or bulge, into and/or through the openings <NUM> when the frame <NUM> is crimped in order to minimize the crimping profile.

As best shown in <FIG>, the lower end of the strut <NUM> is connected to two struts <NUM> at a node or junction <NUM>, and the upper end of the strut <NUM> is connected to two struts <NUM> at a node or junction <NUM>. The strut <NUM> can have a thickness S1 that is less than the thicknesses S2 of the junctions <NUM>, <NUM>. The junctions <NUM>, <NUM>, along with junctions <NUM>, prevent full closure of openings <NUM>. <FIG> shows the prosthetic valve <NUM> crimped on a balloon catheter. As can be seen, the geometry of the struts <NUM>, and junctions <NUM>, <NUM>, and <NUM> assists in creating enough space in openings <NUM> in the collapsed configuration to allow portions of the prosthetic leaflets to protrude or bulge outwardly through openings. This allows the prosthetic valve to be crimped to a relatively smaller diameter than if all of the leaflet material were constrained within the crimped frame.

The frame <NUM> is configured to reduce, to prevent, or to minimize possible over-expansion of the prosthetic valve at a predetermined balloon pressure, especially at the outflow end portion of the frame, which supports the leaflet structure <NUM>. In one aspect, the frame is configured to have relatively larger angles 42a, 42b, 42c, 42d, 42e between struts, as shown in <FIG>. The larger the angle, the greater the force required to open (expand) the frame. As such, the angles between the struts of the frame can be selected to limit radial expansion of the frame at a given opening pressure (e.g., inflation pressure of the balloon). In particular embodiments, these angles are at least <NUM> degrees or greater when the frame is expanded to its functional size, and even more particularly these angles are up to about <NUM> degrees when the frame is expanded to its functional size.

In addition, the inflow and outflow ends of a frame generally tend to over-expand more so than the middle portion of the frame due to the "dog-boning" effect of the balloon used to expand the prosthetic valve. To protect against over-expansion of the leaflet structure <NUM>, the leaflet structure desirably is secured to the frame <NUM> below the upper row of struts <NUM>, as best shown in <FIG>. Thus, in the event that the outflow end of the frame is over-expanded, the leaflet structure is positioned at a level below where over-expansion is likely to occur, thereby protecting the leaflet structure from over-expansion.

In one type of prosthetic valve construction, portions of the leaflets protrude longitudinally beyond the outflow end of the frame when the prosthetic valve is crimped if the leaflets are connected too close to the distal end of the frame. If the delivery catheter on which the crimped prosthetic valve is mounted includes a pushing mechanism or stop member that pushes against or abuts the outflow end of the prosthetic valve (for example, to maintain the position of the crimped prosthetic valve on the delivery catheter), the pushing member or stop member can damage the portions of the exposed leaflets that extend beyond the outflow end of the frame. Another benefit of connecting the leaflets at a location spaced away from the outflow end of the frame is that when the prosthetic valve is crimped on a delivery catheter, the outflow end of the frame <NUM> rather than the leaflets <NUM> is the proximal-most component of the prosthetic valve <NUM>. As such, if the delivery catheter includes a pushing mechanism or stop member that pushes against or abuts the outflow end of the prosthetic valve, the pushing mechanism or stop member contacts the outflow end of the frame, and not leaflets <NUM>, so as to avoid damage to the leaflets.

Also, as can be seen in <FIG>, the openings <NUM> of the lowermost row of openings in the frame are relatively larger than the openings <NUM> of the two intermediate rows of openings. This allows the frame, when crimped, to assume an overall tapered shape that tapers from a maximum diameter at the outflow end of the prosthetic valve to a minimum diameter at the inflow end of the prosthetic valve. When crimped, the frame <NUM> can have a reduced diameter region extending along a portion of the frame adjacent the inflow end of the frame that generally corresponds to the region of the frame covered by the outer skirt <NUM>. In some embodiments, the reduced diameter region is reduced compared to the diameter of the upper portion of the frame (which is not covered by the outer skirt) such that the outer skirt <NUM> does not increase the overall crimp profile of the prosthetic valve. When the prosthetic valve is deployed, the frame can expand to the generally cylindrical shape shown in <FIG>. In one example, the frame of a <NUM>-mm prosthetic valve, when crimped, had a first diameter of <NUM> French at the outflow end of the prosthetic valve and a second diameter of <NUM> French at the inflow end of the prosthetic valve.

The main functions of the inner skirt <NUM> are to assist in securing the valvular structure <NUM> to the frame <NUM> and to assist in forming a good seal between the prosthetic valve and the native annulus by blocking the flow of blood through the open cells of the frame <NUM> below the lower edge of the leaflets. The inner skirt <NUM> desirably comprises a tough, tear resistant material such as polyethylene terephthalate (PET), although various other synthetic materials or natural materials (e.g., pericardial tissue) can be used. The thickness of the skirt desirably is less than about <NUM> (about <NUM> mil), and desirably less than about <NUM> (about <NUM> mil), and even more desirably about <NUM> (about <NUM> mil). In particular embodiments, the skirt <NUM> can have a variable thickness, for example, the skirt can be thicker at least one of its edges than at its center. In one implementation, the skirt <NUM> can comprise a PET skirt having a thickness of about <NUM> at its edges and about <NUM> at its center. The thinner skirt can provide for better crimping performances while still providing good sealing.

The skirt <NUM> can be secured to the inside of frame <NUM> via sutures <NUM>, as shown in <FIG>. Valvular structure <NUM> can be attached to the skirt via one or more reinforcing strips <NUM> (which collectively can form a sleeve), for example thin, PET reinforcing strips, discussed below, which enables a secure suturing and protects the pericardial tissue of the leaflet structure from tears. Valvular structure <NUM> can be sandwiched between skirt <NUM> and the thin PET strips <NUM> as shown in <FIG>. Sutures <NUM>, which secure the PET strip and the leaflet structure <NUM> to skirt <NUM>, can be any suitable suture, such as Ethibond Excel® PET suture (Johnson & Johnson, New Brunswick, New Jersey). Sutures <NUM> desirably track the curvature of the bottom edge of leaflet structure <NUM>, as described in more detail below.

Some fabric skirts comprise a weave of warp and weft fibers that extend perpendicularly to each other and with one set of the fibers extending longitudinally between the upper and lower edges of the skirt. When the metal frame to which such a fabric skirt is secured is radially compressed, the overall axial length of the frame increases. However, a fabric skirt with limited elasticity cannot elongate along with the frame and therefore tends to deform the struts of the frame and to prevent uniform crimping.

Referring to <FIG>, in one embodiment, the skirt <NUM> desirably is woven from a first set of fibers, or yarns or strands, <NUM> and a second set of fibers, or yarns or strands, <NUM>, both of which are non-perpendicular to the upper edge <NUM> and the lower edge <NUM> of the skirt. In particular embodiments, the first set of fibers <NUM> and the second set of fibers <NUM> extend at angles of about <NUM> degrees relative to the upper and lower edges <NUM>, <NUM>. Alternatively, the first set of fibers <NUM> and the second set of fibers <NUM> extend at angles other than about <NUM> degrees relative to the upper and lower edges <NUM>, <NUM>, e.g., at angles of <NUM> and <NUM> degrees, respectively, or <NUM> and <NUM> degrees, respectively, relative to the upper and lower edges <NUM>, <NUM>. In one embodiment, the skirt <NUM> can be formed by weaving the fibers at <NUM> degree angles relative to the upper and lower edges of the fabric. Alternatively, the skirt <NUM> can be diagonally cut (cut on a bias) from a vertically woven fabric (where the fibers extend perpendicularly to the edges of the material) such that the fibers extend at <NUM> degree angles relative to the cut upper and lower edges of the skirt. As further shown in <FIG>, the opposing short edges <NUM>, <NUM> of the skirt desirably are non-perpendicular to the upper and lower edges <NUM>, <NUM>. For example, the short edges <NUM>, <NUM> desirably extend at angles of about <NUM> degrees relative to the upper and lower edges and therefore are aligned with the first set of fibers <NUM>. Therefore the overall general shape of the skirt can be that of a rhomboid or parallelogram.

<FIG> show the inner skirt <NUM> after opposing short edge portions <NUM>, <NUM> have been sewn together to form the annular shape of the skirt. As shown, the edge portion <NUM> can be placed in an overlapping relationship relative to the opposite edge portion <NUM>, and the two edge portions can be sewn together with a diagonally extending suture line <NUM> that is parallel to short edges <NUM>, <NUM>. The upper edge portion of the inner skirt <NUM> can be formed with a plurality of projections <NUM> that define an undulating shape that generally follows the shape or contour of the fourth row of struts <NUM> immediately adjacent the lower ends of axial struts <NUM>. In this manner, as best shown in <FIG>, the upper edge of the inner skirt <NUM> can be tightly secured to struts <NUM> with sutures <NUM>. The inner skirt <NUM> can also be formed with slits <NUM> to facilitate attachment of the skirt to the frame. Slits <NUM> can be dimensioned so as to allow an upper edge portion of the inner skirt <NUM> to be partially wrapped around struts <NUM> and to reduce stresses in the skirt during the attachment procedure. For example, in the illustrated embodiment, the inner skirt <NUM> is placed on the inside of frame <NUM> and an upper edge portion of the skirt is wrapped around the upper surfaces of struts <NUM> and secured in place with sutures <NUM>. Wrapping the upper edge portion of the inner skirt <NUM> around struts <NUM> in this manner provides for a stronger and more durable attachment of the skirt to the frame. The inner skirt <NUM> can also be secured to the first, second, and/or third rows of struts <NUM>, <NUM>, and <NUM>, respectively, with sutures <NUM>.

Referring again to <FIG>, due to the angled orientation of the fibers relative to the upper and lower edges in this embodiment, the skirt can undergo greater elongation in the axial direction (i.e., in a direction from the upper edge <NUM> to the lower edge <NUM>).

Thus, when the metal frame <NUM> is crimped (as shown in <FIG>), the inner skirt <NUM> can elongate in the axial direction along with the frame and therefore provide a more uniform and predictable crimping profile. Each cell of the metal frame in the illustrated embodiment includes at least four angled struts that rotate towards the axial direction on crimping (e.g., the angled struts become more aligned with the length of the frame). The angled struts of each cell function as a mechanism for rotating the fibers of the skirt in the same direction of the struts, allowing the skirt to elongate along the length of the struts. This allows for greater elongation of the skirt and avoids undesirable deformation of the struts when the prosthetic valve is crimped.

In addition, the spacing between the woven fibers or yarns can be increased to facilitate elongation of the skirt in the axial direction. For example, for a PET inner skirt <NUM> formed from <NUM>-denier yarn, the yarn density can be about <NUM>% to about <NUM>% lower than in a typical PET skirt. In some examples, the yarn spacing of the inner skirt <NUM> can be from about <NUM> yarns per cm (about <NUM> yarns per inch) to about <NUM> yarns per cm (about <NUM> yarns per inch), such as about <NUM> yarns per cm (about <NUM> yarns per inch), whereas in a typical PET skirt the yarn spacing can be from about <NUM> yarns per cm (about <NUM> yarns per inch) to about <NUM> yarns per cm (about <NUM> yarns per inch). The oblique edges <NUM>, <NUM> promote a uniform and even distribution of the fabric material along inner circumference of the frame during crimping so as to facilitate uniform crimping to the smallest possible diameter. Additionally, cutting diagonal sutures in a vertical manner may leave loose fringes along the cut edges. The oblique edges <NUM>, <NUM> help minimize this from occurring.

In alternative embodiments, the skirt can be formed from woven elastic fibers that can stretch in the axial direction during crimping of the prosthetic valve. The warp and weft fibers can run perpendicularly and parallel to the upper and lower edges of the skirt, or alternatively, they can extend at angles between <NUM> and <NUM> degrees relative to the upper and lower edges of the skirt, as described above.

The inner skirt <NUM> can be sutured to the frame <NUM> at locations away from the suture line <NUM> so that the skirt can be more pliable in that area. This configuration can avoid stress concentrations at the suture line <NUM>, which attaches the lower edges of the leaflets to the inner skirt <NUM>.

As noted above, the leaflet structure <NUM> in the illustrated embodiment includes three flexible leaflets <NUM> (although a greater or a smaller number of leaflets can be used). Additional information regarding the leaflets, as well as additional information regarding skirt material, can be found, for example, in <CIT>.

The leaflets <NUM> can be secured to one another at their adjacent sides to form commissures <NUM> of the leaflet structure. A plurality of flexible connectors <NUM> (one of which is shown in <FIG>) can be used to interconnect pairs of adj acent sides of the leaflets and to connect the leaflets to the commissure window frame portions <NUM> (<FIG>).

<FIG> shows the adjacent sides of two leaflets <NUM> interconnected by a flexible connector <NUM>. Three leaflets <NUM> can be secured to each other side-to-side using three flexible connectors <NUM>, as shown in <FIG>. Additional information regarding connecting the leaflets to each other, as well as connecting the leaflets to the frame, can be found, for example, in <CIT>.

As noted above, the inner skirt <NUM> can be used to assist in suturing the leaflet structure <NUM> to the frame. The inner skirt <NUM> can have an undulating temporary marking suture to guide the attachment of the lower edges of each leaflet <NUM>. The inner skirt <NUM> itself can be sutured to the struts of the frame <NUM> using sutures <NUM>, as noted above, before securing the leaflet structure <NUM> to the skirt <NUM>. The struts that intersect the marking suture desirably are not attached to the inner skirt <NUM>. This allows the inner skirt <NUM> to be more pliable in the areas not secured to the frame and minimizes stress concentrations along the suture line that secures the lower edges of the leaflets to the skirt. As noted above, when the skirt is secured to the frame, the fibers <NUM>, <NUM> of the skirt (see <FIG>) generally align with the angled struts of the frame to promote uniform crimping and expansion of the frame.

<FIG> shows one specific approach for securing the commissure portions <NUM> of the leaflet structure <NUM> to the commissure window frame portions <NUM> of the frame. In this approach, the flexible connector <NUM> (<FIG>) securing two adjacent sides of two leaflets is folded widthwise and the upper tab portions <NUM> are folded downwardly against the flexible connector. Each upper tab portion <NUM> is creased lengthwise (vertically) to assume an L-shape having a first portion <NUM> folded against a surface of the leaflet and a second portion <NUM> folded against the connector <NUM>. The second portion <NUM> can then be sutured to the connector <NUM> along a suture line <NUM>. Next, the commissure tab assembly is inserted through the commissure window <NUM> of a corresponding window frame portion <NUM>, and the folds outside of the window frame portion <NUM> can be sutured to second portions <NUM>.

<FIG> also shows that the folded down upper tab portions <NUM> can form a double layer of leaflet material at the commissures. The first portions <NUM> of the upper tab portions <NUM> are positioned flat against layers of the two leaflets <NUM> forming the commissures, such that each commissure comprises four layers of leaflet material just inside of the window frames <NUM>. This four-layered portion of the commissures can be more resistant to bending, or articulating, than the portion of the leaflets <NUM> just radially inward from the relatively more-rigid four-layered portion. This causes the leaflets <NUM> to articulate primarily at inner edges <NUM> of the folded-down portions <NUM> in response to blood flowing through the prosthetic valve during operation within the body, as opposed to articulating about or proximal to the axial struts of the window frames <NUM>. Because the leaflets articulate at a location spaced radially inwardly from the window frames <NUM>, the leaflets can avoid contact with and damage from the frame. However, under high forces, the four layered portion of the commissures can splay apart about a longitudinal axis adjacent to the window frame <NUM>, with each first portion <NUM> folding out against the respective second portion <NUM>. For example, this can occur when the prosthetic valve <NUM> is compressed and mounted onto a delivery shaft, allowing for a smaller crimped diameter. The four-layered portion of the commissures can also splay apart about the longitudinal axis when the balloon catheter is inflated during expansion of the prosthetic valve, which can relieve some of the pressure on the commissures caused by the balloon, reducing potential damage to the commissures during expansion.

After all three commissure tab assemblies are secured to respective window frame portions <NUM>, the lower edges of the leaflets <NUM> between the commissure tab assemblies can be sutured to the inner skirt <NUM>. For example, as shown in <FIG>, each leaflet <NUM> can be sutured to the inner skirt <NUM> along suture line <NUM> using, for example, Ethibond Excel® PET thread. The sutures can be in-and-out sutures extending through each leaflet <NUM>, the inner skirt <NUM>, and each reinforcing strip <NUM>. Each leaflet <NUM> and respective reinforcing strip <NUM> can be sewn separately to the inner skirt <NUM>. In this manner, the lower edges of the leaflets are secured to the frame <NUM> via the inner skirt <NUM>. As shown in <FIG>, the leaflets can be further secured to the skirt with blanket sutures <NUM> that extend through each reinforcing strip <NUM>, leaflet <NUM> and the inner skirt <NUM> while looping around the edges of the reinforcing strips <NUM> and leaflets <NUM>. The blanket sutures <NUM> can be formed from PTFE suture material. <FIG> shows a side view of the frame <NUM>, leaflet structure <NUM> and the inner skirt <NUM> after securing the leaflet structure <NUM> and the inner skirt <NUM> to the frame <NUM> and the leaflet structure <NUM> to the inner skirt <NUM>.

<FIG> shows another exemplary prosthetic heart valve <NUM> in an expanded configuration (e.g., when deployed in a patient). The prosthetic heart valve <NUM> of <FIG> can be the same as the prosthetic heart valve <NUM> of <FIG> except that the outer skirt <NUM> of <FIG> has been replaced by a sealing member <NUM> in <FIG>. The prosthetic heart valve <NUM> can include a frame <NUM>, a valvular structure <NUM>, and an inner skirt <NUM>, constructed in a manner similar to the prosthetic heart valve <NUM> of <FIG>. The prosthetic heart valve <NUM> can have an inflow end portion <NUM> and an outflow end portion <NUM> and can define an axial direction from the inflow end <NUM> to the outflow end <NUM>. The sealing member <NUM> can be positioned annularly around an outer surface of the frame <NUM> and secured thereto.

The sealing member <NUM> desirably is sized and shaped to conform to the outer surface of the frame <NUM>. In other words, the inner surface of the sealing member <NUM> can lie flat against the outer surface of the frame <NUM> and can form a snug fit with the outer surface of the frame.

In particular embodiments, the sealing member <NUM> is made from a material that can absorb blood, thus causing the sealing member <NUM> to expand as explained in further detail below. The sealing member <NUM> can be made from, for example, any of various fabrics that are woven, braided or knitted from various types of natural or synthetic fibers, including but not limited to PET fibers (e.g., Dacron), polyester fibers, or polyamide fibers, etc. In certain embodiments, the fabric can be a plush fabric (such as a velour, cloth or towel) having loops or piles of fibers or yarns. In other embodiments, the sealing member <NUM> can be made from any of various non-woven fabrics, such as felt. In still other embodiments, the sealing member <NUM> can be made from a sponge or foam material, such as polyurethane sponge. Other sealing members disclosed herein (including those shown in <FIG>) can be made from the same materials.

In the illustrated example of <FIG>, the sealing member <NUM> has a zig-zag shape around the outer surface of the frame <NUM>, wherein the sealing member <NUM> comprises a plurality of first angled portions 202a having a first orientation with respect to the frame <NUM>, a plurality of second angled portions 202b having a second orientation with respect to the frame <NUM>, a plurality of inflow apices 204a where the first angled portions 202a meet the second angled portions 202b at a location near the inflow end <NUM>, and a plurality of outflow apices 204b where the first angled portions 202a meet the second angled portions 202b at a location relatively closer to the outflow end <NUM>. The first orientation is such that the first angled portions 202a are angled in a direction offset from the axial direction of the prosthetic heart valve <NUM> in a clockwise direction by an angle of less than <NUM> degrees. The second orientation is such that the second angled portions 202b are angled in a direction offset from the axial direction of the prosthetic heart valve <NUM> in a counterclockwise direction by an angle of less than <NUM> degrees.

In the illustrated example of <FIG>, the shape of the sealing member <NUM> is periodic around the surface of the frame <NUM>. In some examples, the shape of the sealing member <NUM> can be sinusoidal or undulating around the surface of the frame <NUM>. In some examples, the inflow apices 204a and the outflow apices 204b can comprise sharp points or angles such that there is an abrupt transition between the first angled portions 202a and the second angled portions 202b. In other examples, the inflow apices 204a and the outflow apices 204b can comprise rounded edges such that there is a gradual transition between the first angled portions 202a and the second angled portions 202b. In the illustrated example of <FIG>, the sealing member <NUM> comprises one continuous piece of material. In other examples, the sealing member <NUM> can comprise multiple pieces of material attached together around the frame <NUM>. The first angled portions 202a and the second angled portions 202b form an angle <NUM> between them. In the illustrated example of <FIG>, the angle <NUM> is less than <NUM> degrees. In other examples, the angle <NUM> can be greater than or equal to <NUM> degrees.

In the illustrated example of <FIG>, the inflow apices 204a are aligned with vertical lines <NUM> of the frame <NUM> and the outflow apices 204b are aligned with vertical lines <NUM>. Alternatively, the inflow and outflow apices 204a, 204b can be aligned with any portion of the frame <NUM>. In the illustrated example of <FIG>, the sealing member <NUM> is secured to the frame <NUM> at the lowermost rows I and II of struts <NUM>, <NUM>. In other embodiments, the sealing member <NUM> can be secured to the frame <NUM> at struts <NUM>, <NUM>, and/or <NUM> over rows III, IV, and/or V. In the illustrated embodiment of <FIG>, the sealing member <NUM> is secured to the frame <NUM> with sutures. Alternatively, the sealing member <NUM> can be secured to the frame <NUM> with adhesive and/or ultrasonic welding in addition to or in lieu of sutures.

The zig-zag shaped sealing member <NUM> gives the prosthetic heart valve <NUM> a relatively low crimped profile. That is, when the prosthetic heart valve <NUM> is crimped into a collapsed configuration, the angle <NUM> is reduced and the first and second angled portions 202a, 202b are positioned closer together than when the prosthetic heart valve <NUM> is in the expanded configuration without overlapping or bunching, which could potentially damage or impair the proper operation of the prosthetic heart valve <NUM>.

The material of the sealing member <NUM> can absorb blood when the prosthetic heart valve <NUM> is implanted in a native valve of a patient and expanded to its expanded configuration. When the sealing member <NUM> absorbs blood, the material of the sealing member <NUM> expands. This expansion of the sealing member <NUM> can help seal any gaps between the prosthetic heart valve <NUM> and the native anatomy and help prevent perivalvular leakage.

<FIG> shows another exemplary prosthetic heart valve <NUM> in an expanded configuration (e.g., when deployed in a patient). Referring to <FIG>, the prosthetic heart valve <NUM> is the same as the prosthetic heart valve <NUM> of <FIG> except that outer skirt <NUM> of <FIG> is positioned and secured to an outer surface of the frame <NUM>. The outer skirt <NUM> can be secured to the frame <NUM> in a similar manner as described with respect to the prosthetic heart valve <NUM> of <FIG>. The outer skirt <NUM> can be secured to the frame <NUM> and can be positioned around an outer surface of the sealing member <NUM>. The outer skirt <NUM> can comprise openings <NUM> that can be aligned with the outflow apices 204b as shown in <FIG>. Alternatively, the openings <NUM> can be aligned with the inflow apices 204a or the openings <NUM> can have any other orientation with respect to the inflow and outflow apices 204a, 204b.

When the prosthetic heart valve <NUM> is implanted in a native valve of a patient and expanded to its expanded configuration, antegrade blood can flow between the frame <NUM> and the outer skirt <NUM>. Antegrade blood can also flow through the openings <NUM>. This antegrade blood can be absorbed by the sealing member <NUM>, which can expand and cause the outer skirt <NUM> to better seal any gaps between the prosthetic heart valve <NUM> and the native anatomy of the patient.

<FIG> shows another prosthetic heart valve <NUM> in an expanded configuration (e.g., when deployed in a patient). Referring to <FIG>, the prosthetic heart valve <NUM> is the same as the prosthetic heart valve <NUM> of <FIG> except that outer skirt <NUM> is positioned between the frame <NUM> and the sealing member <NUM> and the sealing member <NUM> is positioned around and secured to an outer surface of the sealing member <NUM>. The sealing member <NUM> can be secured to the outer skirt <NUM> with sutures. Alternatively, the sealing member <NUM> can be secured to the outer skirt <NUM> with adhesive and/or ultrasonic welding in addition to or in lieu of sutures. In the illustrated embodiment of <FIG>, the openings <NUM> are aligned with the outflow apices 204b. Alternatively, the openings <NUM> can be aligned with the inflow apices 204a or the openings <NUM> can have any other orientation with respect to the inflow and outflow apices 204a, 204b.

When the prosthetic heart valve <NUM> is implanted in a native valve of a patient and expanded to its expanded configuration, antegrade blood can flow between the frame <NUM> and the outer skirt <NUM> and through the openings <NUM>. In addition, antegrade blood can be absorbed by the sealing member <NUM>, which can expand and cause the outer skirt <NUM> to help seal any gaps between the prosthetic heart valve <NUM> and the native anatomy of the patient.

<FIG> shows a flattened view of an outer skirt <NUM> prior to its attachment to a prosthetic heart valve. Referring to <FIG>, the outer skirt <NUM> can comprise a first end portion <NUM> (i.e., the upper end portion as depicted in <FIG>), a second end portion <NUM> (i.e., the lower end portion as depicted in <FIG>), and an intermediate portion <NUM> disposed between the first and second end portions <NUM>, <NUM>. The first end portion <NUM> of the outer skirt <NUM> can include a plurality of alternating projections <NUM> and notches <NUM>, or castellations. The intermediate portion <NUM> can include a sealing member <NUM> similar to sealing member <NUM> of <FIG> secured thereto.

In the illustrated embodiment of <FIG>, the sealing member <NUM> has a zig-zag shape along the length of the intermediate portion <NUM> of the outer skirt <NUM> similar to the zig-zag shape of sealing member <NUM> of <FIG>. The sealing member <NUM> can comprise first angled portions 512a, second angles portions 512b, inflow apices 514a, and outflow apices 514b. In the illustrated embodiment of <FIG>, the inflow apices 514a are axially aligned with the notches <NUM> and the outflow apices 514b are axially aligned with the projections <NUM>. In some embodiments, the inflow apices 514a can be axially aligned with the projections <NUM> and the outflow apices 514b can be axially aligned with the notches <NUM>. In other embodiments, the inflow and outflow apices 514a, 514b can have any other orientation with respect to the projections <NUM> and notches <NUM>. In the illustrated embodiment of <FIG>, the sealing member <NUM> is secured to the outer skirt <NUM> skirt with sutures. Alternatively, the sealing member <NUM> can be secured to the outer skirt <NUM> with adhesive and/or ultrasonic welding in addition to or in lieu of sutures.

<FIG> shows another exemplary prosthetic heart valve <NUM> in an expanded configuration (e.g., when deployed in a patient). Referring to <FIG>, the prosthetic heart valve <NUM> is the same as prosthetic heart valve <NUM> of <FIG> except that outer skirt <NUM> is replaced with the outer skirt <NUM> of <FIG>. The outer skirt <NUM> can be secured to the frame <NUM> in a similar manner as described with respect to the prosthetic heart valve <NUM> of <FIG>. In the illustrated example of <FIG>, the outer skirt <NUM> is positioned around an outer surface of the frame <NUM> and arranged such that the sealing member <NUM> is on the inside of the outer skirt <NUM> (i.e., the sealing member <NUM> is between the frame <NUM> and the skirt <NUM>). In other embodiments, the outer skirt <NUM> can be arranged around the outer surface of the frame <NUM> such that the sealing member <NUM> is on the outside of the outer skirt <NUM>. When the prosthetic heart valve <NUM> is implanted in a native valve of a patient and expanded to its expanded configuration, antegrade blood can flow between the frame <NUM> and the outer skirt <NUM>. This antegrade blood can be absorbed by the sealing member <NUM>, causing the sealing member <NUM> to expand and help the outer skirt <NUM> to seal any gaps between the prosthetic heart valve <NUM> and the native anatomy.

In the illustrated embodiment of <FIG>, the sealing member <NUM> has a zig-zag shape along the length of the intermediate portion <NUM> of the outer skirt <NUM> similar to the zig-zag shape of sealing member <NUM> of <FIG>. The sealing member <NUM> can comprise first angled portions 712a, second angles portions 712b, inflow apices 714a, and outflow apices 714b. The sealing member <NUM> can further comprise a plurality of openings <NUM> in the intermediate portion <NUM>. In the illustrated embodiment of <FIG>, the openings <NUM> have a half oval shape. In other embodiments, the openings <NUM> can have a circular, teardrop, or any other shape. In the illustrated embodiment of <FIG>, the openings <NUM> are axially aligned with the outflow apices 714b and the projections <NUM>. In some embodiments, the openings <NUM> can be axially aligned with the inflow apices 714a and/or the notches <NUM>. In other embodiments, the openings <NUM>, the inflow and outflow apices 714a, 714b, the projections <NUM> and notches <NUM> can have any orientation with respect to each other. In the illustrated embodiment of <FIG>, the sealing member <NUM> is secured to the outer skirt <NUM> skirt with sutures. Alternatively, the sealing member <NUM> can be secured to the outer skirt <NUM> with adhesive and/or ultrasonic welding in addition to or in lieu of sutures.

<FIG> shows another exemplary prosthetic heart valve <NUM> in an expanded configuration (e.g., when deployed in a patient). Referring to <FIG>, the prosthetic heart valve <NUM> is the same as prosthetic heart valve <NUM> of <FIG> except that outer skirt <NUM> is replaced with the outer skirt <NUM> of <FIG>. The outer skirt <NUM> can be secured to the frame <NUM> in a similar manner as described with respect to the prosthetic heart valve <NUM> of <FIG>. In the illustrated example of <FIG>, the outer skirt <NUM> is positioned around an outer surface of the frame <NUM> and arranged such that the sealing member <NUM> is on the inside of the outer skirt <NUM> (i.e., the sealing member <NUM> is in contact with the frame <NUM>). In other embodiments, the outer skirt <NUM> can be positioned around the outer surface of the frame <NUM> such that the sealing member <NUM> is on the outside of the outer skirt <NUM>. When the prosthetic heart valve <NUM> is implanted in a native valve of a patient and expanded to its expanded configuration, antegrade blood can flow between the frame <NUM> and the outer skirt <NUM> and through the openings <NUM>. This antegrade blood can be absorbed by the sealing member <NUM>, causing the sealing member <NUM> to expand and help the outer skirt <NUM> to seal any gaps between the prosthetic heart valve <NUM> and the native anatomy.

<FIG> show other exemplary prosthetic heart valves. The prosthetic heart valves of <FIG> can be the same as prosthetic heart valve <NUM> of <FIG> except with different sealing members replacing sealing member <NUM> of <FIG>. <FIG> shows an exemplary prosthetic heart valve <NUM> having a sealing member <NUM> positioned annularly around frame <NUM> and being secured thereto in a similar manner that sealing member <NUM> is secured to the frame <NUM> in <FIG>. The sealing member <NUM> has an axial span extending about from row I of struts to about row III of struts along the height of the frame <NUM>, although the sealing member can be sized or shaped in other embodiments to extend over other portions of the frame.

The sealing member <NUM> can comprise one or more circumferentially extending rows of openings, such as a first row of a plurality of first openings <NUM> positioned annularly around the frame <NUM> and a second row of a plurality of second openings <NUM> positioned annularly around the frame <NUM>. The sealing member <NUM> can be positioned such that the first openings <NUM> are positioned generally between rows I and II of the frame struts and the openings <NUM> are positioned generally between rows II and III of the frame struts, although the sealing member can be positioned at other locations on the frame in other embodiments. In the illustrated embodiment of <FIG>, the first and second openings <NUM>, <NUM> are axially offset from one another. Alternatively, the first and second openings <NUM>, <NUM> can be axially aligned with each other.

In the illustrated embodiment, the first openings <NUM> are larger than the second openings <NUM>. In other embodiments, the first openings <NUM> can be smaller than the second openings <NUM>, or the same size as the second openings <NUM>. In the illustrated embodiment, the first openings <NUM> are generally hexagonal in shape and the second openings <NUM> are diamond shaped. In other embodiments, the first and second openings can have any of various shapes, including, square, oval, circular, triangular, rectangular, or combinations thereof.

The sealing member <NUM> in the illustrated configuration has undulating inflow and outflow edges <NUM>, <NUM>, respectively. In alternative embodiments, one or more both of the inflow and outflow edges <NUM>, <NUM> can be straight or can have various other configurations.

<FIG> shows an exemplary prosthetic heart valve <NUM> having a sealing member <NUM> positioned annularly around frame <NUM> and being secured thereto in a similar manner that sealing member <NUM> is secured to the frame <NUM> in <FIG>. The sealing member <NUM> has an axial span extending from about from row I of struts to about row II of struts along the frame <NUM>. The sealing member <NUM> has a plurality of circumferentially spaced openings <NUM> positioned annularly around the frame <NUM>. The sealing member <NUM> can be positioned on the frame such that the openings are positioned generally between rows I and II of the frame struts as shown, although the sealing member can be positioned at other locations on the frame in other embodiments.

<FIG> shows an exemplary prosthetic heart valve <NUM> having a sealing member <NUM> positioned annularly around frame <NUM> and being secured thereto in a similar manner that sealing member <NUM> is secured to the frame <NUM> in <FIG>. The sealing member <NUM> in the illustrated embodiment comprises first angled or diagonally extending portions 1120a and second angled or diagonally extending portions 1120b forming a plurality of V or U-shaped projections. The sealing member <NUM> can further include a plurality of straight connecting portions <NUM> extending between and connecting adjacent pairs of V-shaped projections at the bases of first and second angled portions 1120a, 1120b.

<FIG> shows an exemplary prosthetic heart valve <NUM> having a sealing member <NUM> positioned annularly around frame <NUM> and being secured thereto in a similar manner that sealing member <NUM> is secured to the frame <NUM> in <FIG>. The sealing member <NUM> comprises first angled or diagonally extending portions 1220a and second angled or diagonally extending portions 1220b forming a plurality of V or U-shaped projections. The sealing member <NUM> can further include a plurality of first connecting portions 1230a extending between and connecting adjacent pairs of V-shaped projections at the bases of angled portions 1220a, 1220b, and a plurality of second connecting portions 1230b extending between and connecting the angled portions 1220a, 1220b of each V-shaped projection. The second connecting portions 1230b can be axially offset from the first connecting portions 1230a as shown (e.g., the second connecting portions can be located farther from the inlet end of the frame than the first connecting portions). Alternatively, the connecting portions can be located the same distance from the ends of the frame. In other embodiments, the sealing member <NUM> can have various other shapes.

<FIG> shows another exemplary prosthetic heart valve <NUM> in an expanded configuration (e.g., when deployed in a patient). Referring to <FIG>, the prosthetic heart valve <NUM> comprises a frame <NUM> and a valvular structure <NUM>. The valvular structure <NUM> can include a plurality of leaflets <NUM> that are connected to each other to form a plurality of commissures <NUM> secured to the struts of the frame. The prosthetic heart valve <NUM> can have an inflow end portion <NUM> and an outflow end portion <NUM>. The prosthetic heart valve <NUM> can also include an inner skirt <NUM> secured to the inner surface of the frame. The frame <NUM> can expand from a radially collapsed configuration to a radially expanded configuration in a manner similar to the frame <NUM> of <FIG>.

Additionally, the prosthetic heart valve <NUM> in the illustrated embodiment of <FIG> further comprises a sealing member <NUM> positioned annularly around an outer surface of the frame <NUM> and secured thereto. The sealing member <NUM> can be made of a cloth material, a woven fabric, knitted fabric, plush fabric material (e.g., velour), or a towel material, or various other types of material as previously described. In the illustrated embodiment of <FIG>, the sealing member <NUM> has a scalloped or undulating shape around the outer surface of the frame <NUM>. The undulating shape of the sealing member <NUM> helps minimize the overall crimp profile when the prosthetic heart valve is in a radially compressed state for delivery into a patient.

The sealing member <NUM> in the illustrated embodiment comprises three U-shaped sections <NUM> (two of which are visible in <FIG>), with each section <NUM> extending around or circumscribing the frame through an angle of about <NUM> degrees. The adjacent ends of adjacent sections <NUM> meet at junctions <NUM> that can be circumferentially aligned with corresponding commissures <NUM>. The U-shaped sections <NUM> can be positioned on the frame so as to track or follow the shape of the inflow edges of the leaflets <NUM> (which can have a scalloped shaped as shown in <FIG>). As shown, the inner skirt <NUM> can be shaped to cover the openings in the frame <NUM> only at locations below (upstream of) the commissures <NUM> and between adjacent leaflets <NUM>. In this manner, the inner skirt <NUM> need not cover openings in the frame <NUM> above (downstream of) the inlet or cusp edges of the leaflets <NUM>, thereby minimizing the amount of material used to form the inner skirt, which can reduce the overall crimp profile. The inner skirt <NUM> can have an undulating outflow edge that generally corresponds to the shape of the sealing member <NUM> and the inlet edges of the leaflets <NUM>.

In alternative embodiments, the sealing member <NUM> can be formed from more than three U-shaped sections <NUM>, each of which can circumscribe the frame through an angle less than <NUM> degrees.

In particular embodiments, the sealing member <NUM> can absorb blood when the prosthetic heart valve <NUM> is implanted in a native valve of a patient and expanded to its expanded configuration. This can help seal any gaps between the prosthetic heart valve <NUM> and the native anatomy. In the illustrated embodiment of <FIG>, the sealing member <NUM> is secured to the frame <NUM> with sutures. Alternatively, the sealing member <NUM> can be secured to the frame <NUM> with adhesive and/or ultrasonic welding in addition to or in lieu of sutures.

It should be noted that, in some embodiments, the outer skirts <NUM>, <NUM> can comprise creases similar to the creases <NUM> of the outer skirt <NUM>. The creases can be configured to facilitate uniform crimping and/or expansion and/or to reduce the crimped radial profile of a prosthetic heart valve in compressed delivery configuration. In some embodiments, the creases can be formed by ultrasonic welding.

Any of the prosthetic valves <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> can be configured for and mounted on a suitable delivery apparatus for implantation in a patient. Several catheter-based delivery apparatuses can be used; a non-limiting example of a suitable catheter-based delivery apparatus includes that disclosed in <CIT>.

To implant a plastically-expandable prosthetic valve <NUM> or any of the other prosthetic valves disclosed herein within a patient, the prosthetic valve can be crimped on an elongated shaft <NUM> of a delivery apparatus, as best shown in <FIG>. The prosthetic valve, together with the delivery apparatus, can form a delivery assembly for implanting the prosthetic valve <NUM> in a patient's body. The shaft <NUM> comprises an inflatable balloon <NUM> for expanding the prosthetic valve within the body. With the balloon <NUM> deflated, the prosthetic valve <NUM> can then be percutaneously delivered to a desired implantation location (e.g., a native aortic valve region). Once the prosthetic valve <NUM> is delivered to the implantation site (e.g., the native aortic valve) inside the body, the prosthetic valve <NUM> can be radially expanded to its functional state by inflating the balloon <NUM>.

Alternatively, a self-expanding prosthetic valve <NUM> can be crimped to a radially collapsed configuration and restrained in the collapsed configuration by inserting the prosthetic valve <NUM> into a sheath or equivalent mechanism of a delivery catheter. The prosthetic valve <NUM> can then be percutaneously delivered to a desired implantation location. Once inside the body, the prosthetic valve <NUM> can be advanced from the delivery sheath, which allows the prosthetic valve to expand to its functional state.

<FIG> and <FIG> show various implantation positions for a prosthetic heart valve <NUM>, including implantation within a dock or anchor placed inside the patient's body prior to valve implantation. Alternatively, the prosthetic heart valve <NUM> of <FIG> and <FIG> can be replaced with prosthetic heart valve <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. <FIG> shows the prosthetic heart valve <NUM> implanted in the native aortic valve of a patient.

<FIG> shows the prosthetic heart valve <NUM> implanted in the pulmonary artery of a patient for replacing or enhancing the function of a diseased pulmonary valve. Due to the variations in the size and shape of the native pulmonary valve and the pulmonary artery, the prosthetic valve <NUM> can be implanted within a radially expandable outer docking device <NUM>. The docking device <NUM> can comprise a radially expandable and compressible annular stent <NUM> and a sealing member <NUM> that covers all or a portion of the stent and can extend across the inner surface and/or outer surface of the stent. The docking device <NUM> is configured to engage the inner wall of the pulmonary artery and can accommodate variations in patient anatomy. The docking device <NUM> also can compensate for the expanded prosthetic heart valve <NUM> being much smaller than vessel in which it is placed. The docking device <NUM> also can be used to support a prosthetic valve in other areas of the patient's anatomy, such as, the inferior vena cava, superior vena cava, or the aorta. Further details of the docking device <NUM> and methods for implanting the docking device and a prosthetic valve are disclosed, for example, in co-pending <CIT>.

<FIG> shows the prosthetic heart valve <NUM> implanted in the native mitral valve of a patient using a docking device in the form of a helical anchor <NUM>. The helical anchor <NUM> can include one or more coils <NUM> deployed in left atrium and one or more coils <NUM> deployed in the left ventricle and radially outside of the native mitral valve leaflets <NUM>. When the prosthetic valve <NUM> is deployed within the native valve, the native leaflets are compressed or pinched between the prosthetic valve <NUM> and the anchor <NUM> to retain the prosthetic valve in place. Further details of the helical anchor <NUM> and methods for implanting the anchor and a prosthetic valve are disclosed, for example, in co-pending <CIT>.

<FIG> show a docking device <NUM> for a prosthetic heart valve, according to another embodiment. The docking device <NUM> can include a radially expandable and compressible frame <NUM> having an outer portion <NUM>, an inner portion <NUM> disposed coaxially within one end portion of the outer portion <NUM>, and a curved transition portion <NUM> extending between and connecting the inner portion <NUM> and the outer portion <NUM>. The docking device <NUM> can further include a sealing member <NUM> extending over the inner surface of the inner portion <NUM>, a portion of the outer surface of the outer portion <NUM> adjacent the inner portion <NUM>, and the transition portion <NUM>.

<FIG> shows the docking device <NUM> implanted in a vessel <NUM>, which can be, for example, the inferior vena cava, superior vena cava, or the ascending aorta. As shown, a prosthetic valve <NUM> can be deployed within the inner portion <NUM> of the docking device <NUM>. Similar to the docking device <NUM>, the docking device <NUM> can compensate for the expanded prosthetic heart valve <NUM> being much smaller than vessel in which it is placed. The docking device <NUM> is particularly suited for implanting a prosthetic valve in the inferior vena cava for replacing or enhancing the function of the native tricuspid valve. Further details of the docking device <NUM> and methods for implanting the docking device and a prosthetic valve are disclosed, for example, in co-pending <CIT> (publication no.

It should be understood that the disclosed prosthetic valves can be implanted in any of the native annuluses of the heart (e.g., the pulmonary, mitral, and tricuspid annuluses), and can be used with any of various approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.). The disclosed prostheses can also be implanted in other lumens of the body.

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. For example, an outer sealing member for a prosthetic heart valve can include one or more features disclosed with respect to skirt <NUM>, sealing member <NUM>, sealing member skirt <NUM>, skirt <NUM>, sealing member <NUM>, sealing member <NUM>, sealing member <NUM>, sealing member <NUM>, and/or sealing member <NUM>.

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.

As used herein, the term "and/or" used between the last two of a list of elements means any one or more of the listed elements. For example, the phrase "A, B, and/or C" means "A", "B", "C", "A and B", "A and C", "B and C", or "A, B, and C".

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.

As used herein, the terms "coupled" and "associated" generally mean physically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

As used herein, operations that occur "simultaneously" or "concurrently" occur generally at the same time as one another, although delays in the occurrence of one operation relative to the other due to, for example, spacing, play or backlash between components in a mechanical linkage such as threads, gears, etc., are expressly within the scope of the above terms, absent specific contrary language.

Claim 1:
An implantable prosthetic valve (<NUM>; <NUM>; <NUM>; <NUM>) comprising:
an annular frame (<NUM>) comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration;
a leaflet structure positioned within the frame (<NUM>) and secured thereto;
an annular sealing member (<NUM>; <NUM>); and
an outer skirt (<NUM>; <NUM>; <NUM>), wherein
the annular sealing member (<NUM>; <NUM>; <NUM>) is positioned around an outer surface of the frame (<NUM>) and has a periodic, undulating shape, and the outer skirt (<NUM>; <NUM>) is positioned around an outer surface of the sealing member (<NUM>; <NUM>; <NUM>) and secured to the frame (<NUM>).