Artificial Heart Valves

Abstract

Techniques for constructing a prosthetic heart valve, particularly techniques for attaching the scalloped edges of a valve leaflet to struts of a mechanical frame using sutures / other materials as intermediate attachment members, are disclosed. In some embodiments, the scalloped edges of the leaflets are attached to portions of the struts of the frame via suture loops oriented across the scalloped edges of the leaflets, with the central portion of the scalloped line attached to the scalloped edges of the leaflets and not attached to the frame. In some embodiments, the strut portions are tapered to limit translation of the suture loops. In some embodiments, fabric strips connect the scalloped edges of the leaflets to the frame struts. In some embodiments, the scalloped edges are attached to adjacent portions of the intersecting struts via sliding suture loops, with the adjacent portions joining at a common pivot junction.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 62 / 885,556, filed Aug. 12, 2019, which is incorporated herein by reference.

[0002] The present disclosure relates to a prosthetic heart valve having a radially collapsible and expandable mechanical frame and scalloped leaflets attached to struts of the frame. [Background technology]

[0003] Among the methods of assembling the leaflets into the prosthetic valve are those that attach the leaflets to the scalloped suture lines of the frame struts via a series of suture loops. Because the leaflets are also attached to the frame via the commissures at their opposing side ends, changes in frame diameter, such as a transition from a fully expanded to a compressed state during a crimping procedure that increases the longitudinal distance between the opposing coaptations of the frame cells, can result in elongation and compression of the leaflets and high stress concentrations along the suture loops. Additionally, the systolic and diastolic cycles acting on the frame as the prosthetic valve is implanted can result in wear of the suture loops and leaflets in the attachment areas. Summary of the Invention [Means for solving the problem]

[0004] Disclosed herein are several novel techniques for constructing prosthetic heart valves, particularly techniques for attaching the scalloped edges of the valvular leaflets to the struts of a mechanical frame using sutures and / or other materials as intermediate attachment members.

[0005] Some exemplary prosthetic heart valves include a radially expandable and foldable annular frame including a plurality of intersecting struts coupled together at mechanical pivot joints, such that radial expansion or contraction of the annular frame causes the intersecting struts to pivot relative to one another at the pivot joints, and a valvular structure mounted within the frame and regulating blood flow through the prosthetic heart valve, the valvular structure including valve leaflets, the leaflets coupled to the frame at their lateral commissure ends and along scalloped edges of the leaflets extending between the commissure ends, the scalloped edges of the leaflets coupled to portions of the struts of the frame via suture loops, the strut portions to which the suture loops are coupled being oriented substantially perpendicular to the scalloped edges of the leaflets.

[0006] Coupling the scalloped edges of the leaflets to strut portions oriented substantially perpendicular to the scalloped edges allows the scalloped edges to move relative to the strut portions via the suture loops sliding along the strut portions during radial expansion and compression of the frame. Anatomical forces along the scalloped edges acting on the leaflets at their attachment points to the struts during systole and diastole can be substantially perpendicular to the suture loops, thereby inhibiting undesirable wear of the suture loops and leaflets.

[0007] In some embodiments, the scalloped edge of each leaflet is coupled via suture loops to at least six distinct strut portions of the frame, for example, the at least six distinct struts may include three parallel strut portions on one side of the scalloped edge and another three parallel strut portions on a second side of the scalloped edge.

[0008] Some exemplary prosthetic heart valves include a scallop line substructure including three scallop line elements, each of which is attached to one scallop edge of each of the three leaflets, each of which includes two opposing ends and a central portion between the two opposing ends, the ends being attached to the frame with the lateral ends of the leaflets at the commissures, and the central portion of the scallop line element being attached to the scallop edges of the leaflets and not attached to the frame. In some such embodiments, the scallop line elements are formed of a rigid material, such as a metal or metal alloy, and are elastically deformable to resist radially inward displacement of the scallop edges of the leaflets. In other embodiments, the scallop line elements are formed of a soft material, such as a short skirt, fabric, cable, or string. In some embodiments, the scallop line elements have flexibility that allows the central portion of the scallop line elements to deform from a generally U-shaped to a generally V-shaped during radial compression of the frame while the ends of the scallop line elements move toward each other.

[0009] In some exemplary prosthetic heart valves, the scalloped edge of each leaflet is coupled to a strut portion via a fabric strip, with a first end of the fabric strip attached to the scalloped edge and a second, opposite end of the fabric strip separately attached to the strut portion. In some such embodiments, the first end of the fabric strip is attached to the scalloped edge via a first suture and the second end of the fabric strip is attached to the strut portion via a second suture separate from the first suture. In some embodiments, the second suture is looped around the strut portion and a portion of the first end of the fabric strip. In some embodiments, the first end of the fabric strip extends around at least two sides of the strut portion.

[0010] In some prosthetic heart valves, the struts of the frame include multiple strut sections between pivot junctions, with at least some of the strut sections tapering in width between the pivot junctions. In some such embodiments, the strut sections tapered such that the reduction in width moves from the inflow end toward the outflow end. In some embodiments, the leaflets are coupled to the tapered strut sections via suture loops such that a suture loop extending around the tapered strut section is large enough to fit around the narrow end of the tapered strut section, but small enough not to fit around the wide end of the tapered strut section. The suture loop may be configured to slide along the tapered strut section from the narrow end toward the wide end, and frictionally secure, or "self-lock," at an intermediate position along the tapered strut section where the circumference of the suture loop is equal to the strut section.

[0011] In some prosthetic heart valves, each scalloped edge is attached to an adjacent portion of an intersecting strut via a sliding suture loop, the adjacent portions joining at a common pivot junction of a pivot junction, and the sliding suture loop can slide along the adjacent portion toward and away from the common pivot junction. The sliding suture loop can slide along the adjacent portion toward the common pivot junction during radial frame expansion, and the sliding suture loop can slide along the adjacent portion away from the common pivot junction during radial frame contraction.

[0012] 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 drawings. [Brief description of the drawings]

[0013] [Figure 1] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 2A]FIG. 1 illustrates another prosthetic heart valve, showing coupling of the leaflets to the frame. [Figure 2B] FIG. 2B is an enlarged view of a portion of FIG. 2A. [Figure 3A] FIG. 1 illustrates another prosthetic heart valve, showing coupling of the leaflets to the frame. [Figure 3B] FIG. 2B is an enlarged view of a portion of FIG. 2A. [Figure 4A] FIG. 1 illustrates another prosthetic heart valve, showing coupling of the leaflets to the frame. [Figure 4B] FIG. 1 illustrates another prosthetic heart valve, showing coupling of the leaflets to the frame. [Figure 5A] FIG. 2 is an internal view of the prosthetic heart valve showing the attachment of the leaflets to the frame. [Figure 5B] FIG. 2 is an internal view of the prosthetic heart valve showing the attachment of the leaflets to the frame. [Figure 6A] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 6B] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 6C] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 6D] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 6E] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 7] 13A-13D show an exemplary suturing scheme for connecting the leaflets to the frame struts. [Figure 7A] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 7B] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 8A] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 8B] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 8C] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 9A] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 9B] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 10A] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 10B] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 10C] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 10D] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 10E] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 10F] 1A-1C illustrate various stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 11] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 12A] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 12B] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 13] FIG. 13 illustrates coupling the leaflets to the struts using suture loops that extend around the struts and through the leaflets. [Figure 14] FIG. 13 illustrates coupling the leaflets to the struts using fabric strips with one end coupled to the struts and the other end coupled to the leaflets. [Figure 15] FIG. 13 shows a suture pattern for connecting the leaflets to the struts using fabric strips. [Figure 16] FIG. 2 illustrates a portion of a prosthetic heart valve showing coupling of the leaflets to a frame. [Figure 17] FIG. 13 shows a frame strut configured with a tapered section. [Figure 18] FIG. 13 shows a frame strut configured with a tapered section. [Figure 19A] FIG. 1 illustrates a prosthetic heart valve showing attachment of the leaflets to a frame. [Figure 19B] FIG. 19B is an enlarged view of a portion of FIG. 19A. [Figure 20A] 1A-1D illustrate stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 20B] 1A-1D illustrate stages of radial compression of a prosthetic heart valve, showing the change in dimensions of the frame cells. [Figure 21A] FIG. 13 illustrates attachment of the leaflets to a frame with suture loops, showing how the suture loops can slide along the strut portions. [Figure 21B] FIG. 13 illustrates attachment of the leaflets to a frame with suture loops, showing how the suture loops can slide along the strut portions. [Figure 22A] FIG. 2 is an internal view of the prosthetic heart valve showing the attachment of the leaflets to the frame. [Figure 22B] FIG. 22B is an external view of the artificial heart valve of FIG. 22A. [Figure 23A] 13A-13D show a further technique for suturing the leaflets and other material to the inside of the frame. [Figure 23B] 13A-13D show a further technique for suturing the leaflets and other material to the inside of the frame. [Figure 23C] 13A-13D show a further technique for suturing the leaflets and other material to the inside of the frame. [Figure 23D] 13A-13D show a further technique for suturing the leaflets and other material to the inside of the frame. [Figure 24] FIG. 1 illustrates a prosthetic heart valve showing attachment of the leaflets to a frame. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] Disclosed herein are novel prosthetic heart valves and associated components, systems, and methods. Some disclosed embodiments include novel methods of attaching each leaflet to a strut of a radially expandable and radially collapsible frame, where the individual struts of the frame are pivotally coupled to each other at strut junctions (e.g., a mechanical frame). Novel methods of attaching the leaflets to the struts may include embodiments in which the scalloped portions of the leaflets are sutured to adjacent struts that are transverse or substantially perpendicular to the scallop stitch line, rather than to struts that are substantially parallel to the scallop stitch line. In some embodiments, the suture loops by which the leaflets are attached to the struts are configured to be slidably movable along the respective struts, allowing for displacement of the scalloped edges of the leaflets along the longitudinal / axial direction, thereby reducing stress concentrations acting on the leaflets in the suture loops and the regions of attachment of the suture loops.

[0015] 1 shows an example of attachment of leaflets 50 to a frame 10 of a prosthetic valve. The frame 10 may include a plurality of overlapping struts joined at strut junctions, which may include mechanical pivot joints. The struts may include a first strut group strut that are generally parallel to one another and extend diagonally in a first direction (or chirality), which may include, for example, strut 22. The struts may also include a second strut group strut that are generally parallel to one another and extend diagonally in a second direction (or chirality) transverse to the first direction, which may include, for example, strut 24. The struts of the first strut group struts may be joined to the struts of the second strut group struts with which they overlap / cross via pivot joints (e.g., strut junctions 26 and 28). Either strut group can overlay the other strut group, as shown in Figure 1. As the frame 10 radially expands and collapses, the struts pivot at the strut junctions. When the frame is fully expanded, the struts are more circumferentially oriented, and when the frame is radially collapsed, the struts are more axially oriented.

[0016] The prosthetic valve may include multiple leaflets 50, e.g., three leaflets, each attached to the frame 10 along its scalloped edge via two opposing commissures 52 (shown in side view in FIG. 1). Shown in FIG. 1 is a scallop stitch line 54, for example, used to attach an inner skirt to the scalloped region of the leaflets 50. The leaflets 50 extend beyond the scallop stitch line 54 and are further attached to struts of the valve frame that are generally parallel to the scallop stitch line 54 via suture loops 60. In this example, the leaflets 50 are attached to struts 22 and 24 via suture loops 60 generally parallel to the scallop stitch line 54. The suture loops 60 are positioned along the struts 22 and 24 down to the intersection of the strut junctions 26.

[0017] 1 in an expanded state, with exemplary cells 12 delimited by dashed lines. Frame cells 12 have a longitudinal distance Lc between two opposing strut junctions 26 and 28. When frame 10 is radially compressed, such as during a crimping process, the distance Lc between junctions 26 and 28 increases, potentially up to twice its distance in the fully expanded state, thereby axially stretching leaflets 50, which may result in high stress concentrations along suture loops 60.

[0018] Another disadvantage of the configuration of FIG. 1 is that the vibratory motion of frame 10 places additional stress concentrations on suture loops 60 when the implanted prosthetic valve is subjected to pulsating systolic and diastolic cycles.

[0019] In other embodiments, the valve is constructed using a method in which each leaflet is stitched along its scalloped edge to struts perpendicular to the scallop stitch line via slidable suture loops, instead of struts parallel to the scallop stitch line as in FIG.

[0020] 2A and 2B show an embodiment of a prosthetic valve in which leaflets 50 are attached to a fully expanded frame 10 via suture loops 70 at two commissures 52a, 52b, and at struts 32, 34, 36, 42, 44, and 46, all transversely and / or substantially perpendicular to the scallop stitch line 54, rather than to struts 22 or 24.

[0021] Figure 2B shows an enlarged view of region 2B of Figure 2A. Figure 2B shows suture loop 70 attaching scallop 50 to strut 36 between its junctions J1 and J2. Suture 70, located in Figure 2B adjacent junction J1, is able to slide between these two adjacent junctions, relieving stress buildup.

[0022] FIG. 3A shows the leaflet 50 attached to the frame 10 as in FIG. 2A, with the frame 10 in FIG. 3A slightly compressed relative to its state in FIG. 2A. FIG. 3B shows an enlarged view of region 3B in FIG. 3A. Suture loops 70a, 70b, and 70c attach the leaflet 50 to the struts 32, 34, and 36, respectively. As shown in FIG. 3B, each suture loop 70 can slide along its respective strut in response to the state and shape of the frame 10 and the forces acting thereon as a result of the structural configuration and attachment area of ​​the scallop 50. Suture loop 70a is slidably movable between junctions J5 and J6. Suture loop 70b is slidably movable between junctions J3 and J4. Suture loop 70c is slidably movable between junctions J1 and J2. Suture loops 70b and 70a are disposed closer to the midsection between their corresponding junctions, while suture loop 70c is disposed closer to one of the junctions, namely J1.

[0023] FIG 4A shows two adjacent leaflets 50a and 50b attached to the frame 10. Both leaflets 50a and 50b are attached to a support strut of the frame via commissure 52b. Leaflet 50a is shown attached to a strut substantially perpendicular to the scallop stitch line 54 via suture loops 70a, 70b, and 70c. Leaflet 50b is shown attached to a strut substantially perpendicular to the scallop stitch line 54 via suture loops 70g, 70h, and 70i. FIG 4B shows leaflet 50a attached to the frame at two commissures 52a and 52b and attached to a strut substantially perpendicular to the scallop stitch line 54 via suture loops 70a, 70b, 70c, 70d, 70e, and 70f.

[0024] 5A and 5B show top views of leaflet 50 attached via suture loops 70a, 70b and 70c, respectively, to struts substantially perpendicular to scalloped stitch line 54, such as struts 32, 34 and 36. FIG.

[0025] Figures 6A through 6E show different transition stages between a radially expanded frame (Figure 6A) and a radially compressed frame (Figure 6E). The longitudinal distance Lc between two opposing junctions of the cells of the frame increases from Lc1 to Lc5 such that Lc1 < Lc2 < Lc3 < Lc4 < Lc5. Suture loop 70a is slidably movable between junctions J5 and J6, and suture loop 70b is slidably movable between junctions J7 and J6. The positions of suture loops 70a and 70b vary along the struts between their respective junctions according to the changing frame diameter.

[0026] Advantageously, this disclosed configuration of valve tip attachment to the frame allows for movement of the scalloped edge along the struts during expansion or compression of the frame while avoiding the stress concentration that occurs near suture loop 60 for valve tip elongation according to the prior art attachment mode illustrated in FIG. 1.

[0027] A further advantage is that during systole and diastole, the forces acting on the valve tip at its attachment point to the strut are orthogonal to the attachment of suture loop 70, thereby suppressing undesirable wear of the suture loop and valve tip.

[0028] According to some embodiments, the struts include openings along their length and the leaflets include openings along the circumference of their scalloped lines, the openings adapted to receive the suture loops 70 therethrough. FIG. 7 shows a strut 30 with multiple opening couples 80 at different locations along its length and a portion of a leaflet 50 with one opening 90 couple, such that the leaflet is placed over the strut with its openings 90 aligned with two matching strut openings. Advantageously, this configuration facilitates attachment of the leaflet 50 to the strut 30. According to some embodiments, the suture loops 70 are not very tightly attached to the struts, but rather are loose enough to allow them to slide along their respective struts.

[0029] A further advantage of the current configuration is that it allows optimization of leaflet design without being restricted to designs that require the leaflets to be continuously attached to struts that are substantially parallel to the scallop stitch line.

[0030] Some prosthetic valves can be constructed by attaching the leaflets to a skirt attached to their scallop lines, and the skirt is sutured to struts that are substantially parallel to their scallop suture lines. In some embodiments, the skirt is sutured to both struts that are substantially parallel to the scallop suture lines and to struts that are substantially perpendicular. Because the leaflets are also attached to the frame via commissures at opposite longitudinal ends, a change in frame diameter, such as a transition from a fully expanded state to a compressed state during a crimping procedure that increases the longitudinal distance between the opposing joints of the frame cells, can stretch the leaflets and create high stress concentrations there.

[0031] In some embodiments, the prosthetic valve may include a scallop line substructure including three scallop line elements, each line element configured to be attached to a respective leaflet. Each scallop line element may include two opposing ends and a central portion disposed between the ends. The central portion may be attached (e.g., sutured) to the cusps of the leaflets. The ends may be connected to the frame (with the leaflets) at the commissures. The central portion may be free from the frame (i.e., not attached to the struts of the frame). The scallop line elements may be formed of a flexible material, so that they can be compressed from a U-shape to a V-shape during compression / crimping of the frame. The scallop line elements may be formed of a rigid material (metal, nitinol, etc.) and may be spring-biased against the frame. The scallop line elements may be formed of a soft material (short skirt, fabric, cable, string, etc.) that may be connected to at least one strut by at least one suture loop to prevent radial inward displacement of the central portion. In some embodiments, the scallop line element is configured to prevent the formation of creases in the leaflets at any diameter of the frame.

[0032] 7A-7B show examples of conventional attachment of leaflets to a frame of a prosthetic valve. FIG. 7A shows two adjacent leaflets 150a and 150b attached to a frame 110. Both leaflets 150a and 150b are attached to a support strut of the frame via a commissure 152b. The leaflets 150a and 150b are sutured to the inner skirt 130 via scallop stitch lines 154a and 154b. FIG. 7B shows the leaflet 150a attached to the frame at the two commissures 152a and 152b. The leaflet 150a is sutured to the inner skirt 130 via a scallop stitch line 154. The skirt 130 is shown attached to struts both substantially perpendicular and substantially parallel to the scallop stitch lines 154a, 154b via suture loops 116.

[0033] 7B in an expanded state, with an exemplary cell 112 shown with a longitudinal distance Lc between two opposing joints. When the frame 110 is radially compressed, e.g., during a crimping process, the distance Lc is stretched, in some cases up to twice its distance in the fully expanded state. The stretching of the skirt 130 is transferred to a corresponding displacement of the leaflets 150a due to their connection with the skirt 130 at the scalloped suture line 154, which also stretches the leaflets 150a axially, resulting in high stress concentrations along the suture loops 116 and the scalloped suture line 154.

[0034] Another disadvantage of this configuration is that when the implanted prosthetic valve is subjected to pulsating systolic and diastolic cycles, the vibratory motion of the frame 110 places additional stress concentrations on the suture loops 116 and the scalloped suture lines 154.

[0035] Referring to FIGS. 8A through 8C, some exemplary prosthetic valves employ a method of suturing each valve leaflet along its tip to a scallop line element 140, which is attached to the frame at least at the commissures. The prosthetic valve may include a plurality of valve leaflets, e.g., three valve leaflets, each attached to the frame 110 along its scalloped edge via two opposing commissures. FIG. 8A shows three scallop line elements 140a, 140b, and 140c, configured to attach (not shown in FIGS. 8A - 8C for simplicity) to the tips of valve leaflets 150a, 150b, and 150c, respectively, via sutures. Each scallop line element includes two opposing ends 142 configured to extend towards the commissural attachment region of the valve leaflet 150, and a central portion 144 disposed between the ends 142 configured to conform to the shape of the tip. The scallop line elements 140a, 140b, and 140c may be formed as separate elements. According to some embodiments, the scallop line elements 140a, 140b, 140c may be attached to each other (e.g., at the ends 142) and together form a scallop line infrastructure 140. According to some embodiments, the scallop line elements 140a, 140b, 140c are pre - assembled to form the scallop line infrastructure 140, such that all the tips of all the valve leaflets can be attached (e.g., sutured) to the scallop line infrastructure 140. According to some embodiments, all the scallop line elements are integrally formed as a single scallop line infrastructure 140. FIGS. 8A through 8C show various transition stages between a radially expanded frame (FIG. 8A) and a compressed frame (FIG. 8C). The longitudinal distance Lc between two opposing junctions of the cells of the frame increases from Lc1 to Lc2 such that Lc1 < Lc2 < Lc3.

[0036] According to some embodiments, at the commissures 152, only the ends 142 are attached to the frame 110 along with the leaflets 150, while the central portions 144 attached to the apical ends of the leaflets are not attached to the frame struts and are loosely positioned around the inner surface of the frame 110.

[0037] The scallop line element 140 has internal flexibility configured to allow its central portion 144 to compress while the opposing ends 142 move toward one another during frame compression (see FIG. 8C).

[0038] Preferably, the scallop line element 140 is designed to maintain an optimized leaflet shape during valve performance and during transitions between frame states to extend its durability. Specifically, the scallop line element 140 is designed to prevent creases from forming in the leaflets 150 at any diameter of the frame 140. According to some embodiments, the scallop line element 140 is made from a relatively rigid material configured to prevent deformation thereof, except for the desired flexibility of the central portion 144 during diameter changes of the frame 110. According to some embodiments, the scallop line element 140 is formed from a wire (e.g., laser cut wire), such as cobalt chrome or nitinol. According to some embodiments, the scallop line element 140 is spring-loaded against the inner surface of the frame 110 to prevent radial inward displacement of the central portion 144.

[0039] According to some embodiments, the scallop line element 140 is made of a soft material such as string, cable, suture, fabric, etc. According to some embodiments, the scallop line element 140 further includes at least one attachment point (e.g., via a suture loop) of the central portion 144 to at least one strut to prevent inward radial displacement of the central portion 144.

[0040] Advantageously, most of the axial force is transferred through the disclosed arcuate configuration of the scallop line element 140 toward the attachment area of ​​the end portion 142 to the commissure 152 .

[0041] Some embodiments include leaflets attached to the scallop line substructure using short skirts or fabric strips. Figure 9A shows two adjacent leaflets 150a and 150b attached to the support struts of the frame via commissures 152b. The leaflets 150a and 150b are attached to the scallop line substructure 140 via scallop suture lines 154a and 154b, respectively. Figure 9A shows the leaflet 150a attached to the frame at two commissures 152a and 152b. If the scallop line substructure 140 of the embodiment shown in Figures 9A-9B is made of a flexible material such as fabric, the scallop line substructure 140 may be attached to the struts of the frame 110 via several suture loops 170 to prevent radial inward displacement of the central portion 144.

[0042] In the embodiment shown in Figures 9A-9B, the mode of attachment to the frame 110 may be such that the scallop line base structure 140 is attached to struts substantially perpendicular to the scallop stitch line 154 via suture loops 170 such that each suture loop 170 can slide along a respective strut.

[0043] According to some embodiments, the scallop line foundation 140 includes a fabric strip surrounding a reinforcing member, such as a reinforcing strip, disposed between the fabric and the cusps of the leaflets sutured thereto.

[0044] Figures 10A through 10F show different transition stages between a radially expanded frame (Figure 10A) and a radially compressed frame (Figure 10F). The longitudinal distance Lc between two opposing junctions of the cells of the frame increases from Lc1 to Lc6 such that Lc1 < Lc2 < Lc3 < Lc4 < Lc5 < Lc6. The position of the suture loops 170 varies along the struts between their respective junctions according to the changing frame diameter.

[0045] The configuration of the embodiments shown in Figures 9A through 10F may present the disadvantage of bringing the suture loops 170 of adjacent struts closer to each other in the crimped configuration (e.g., Figure 10F), whereas the embodiments shown in Figures 8A through 8C avoid such a risk because the scallop line infrastructure 140 is not connected to the struts via such suture loops.

[0046] Some assembly methods for attaching valve leaflets to the frame of an artificial valve include attaching the valve leaflets to a fabric strip (forming a skirt) via a scallop stitch line and attaching the valve leaflets together with the fabric strip to the frame struts via a series of suture loops. However, there are several challenges with this process. Such challenges may include: (1) the difficulty arising from sewing suture loops through the fabric strip and the valve leaflet tissue (potentially a much easier process compared to when the loops can be sewn through the fabric strip without the valve leaflet), (2) the need for expertise to provide high precision and reproducibility of the process and the difficulty of attaching the valve leaflets to struts close to the scallop line, (3) the fabric of the skirt being subject to high wear and potentially having low long-term durability, and (4) the long assembly time required to attach the skirt to multiple struts.

[0047] To overcome these problems, the leaflets can be attached to the frame by first sewing a fabric strip (inner skirt) to the leaflets via a scallop stitch line, and then attaching the fabric strip to the struts by a suture loop that extends through the fabric and around the struts. This allows the leaflets to be indirectly attached to the struts via the fabric strip, i.e., not directly sutured to the struts themselves. Thus, the attachment process is greatly simplified and assembly time is reduced. The fabric can be provided with pre-cut stitch holes for the scallop stitch line and the suture loop. The holes can follow the geometric pattern of the struts, such as a zigzag pattern, thus improving the bond and precision of the assembly. The fabric strip can also act as a soft hinge connection. The distance between the scallop stitch line and the suture loop can be more precisely controlled.

[0048] FIG. 11 illustrates one type of attachment of leaflets 250 to a frame 210 of a prosthetic valve. The prosthetic valve may include multiple leaflets 250, each attached to the frame 210 along its scalloped edge via two opposing commissures 252. FIG. 11 illustrates a scallop stitch line 254 that is used to attach a skirt to the scalloped region of the leaflet 250. According to some embodiments, the skirt may include a first fabric 232 disposed between the scallop line of the leaflet 250 and the struts 212, and a second fabric 234 (see FIG. 13) attached to a surface opposite the scallop line of the leaflet 250, facing the lumen of the frame 210.

[0049] As shown in FIG. 11, the leaflets are attached to the struts 212 via suture loops 260 that extend through the first and second fabrics 232, 234, through the apex of the leaflets 250, and around the struts 212.

[0050] 12A-12B show another type of attachment of leaflets 250 to a frame 210 of a prosthetic valve. FIG. 12A shows two adjacent leaflets 250a and 250b attached to the frame 210. Both leaflets 250a and 250b are attached to the frame's support struts via commissures 252b. FIG. 11B shows the leaflet 250a attached to the frame at two commissures 252a and 252b. Both leaflets 250a and 250b are sutured to the skirt (having a first fabric 232 and a second fabric 234) via scallop stitch lines 254a and 254b, respectively. The first fabric 232 is shown attached to several different struts 212 both substantially parallel and substantially perpendicular to the scallop stitch lines 254a, 254b via suture loops 260.

[0051] The varying distance L indicates the distance between the scallop stitch line 254 and the suture loop 260. According to some embodiments, the maximum or average distance L in the embodiments shown in Figures 12A-12B is greater than the maximum or average distance L, respectively, of the embodiment shown in Figure 11. According to some embodiments, the maximum or average distance L in the embodiments shown in Figures 12A-12B can be as high as 2 mm.

[0052] 13 shows a schematic of the attachment of FIG. 11, where the first fabric 232 and second fabric 234 are sewn to either side of the leaflet 250 via a scalloped stitch line 254. A suture loop 260 extends through the second fabric 234, the leaflet 250, the first fabric 232, and around the strut 212.

[0053] An improved mode of attaching the leaflet 250 to the strut 212 includes separately attaching the fabric 230 to the scallop line of the leaflet 250 at one end and to the strut 212 along its opposite end. FIG. 14 shows a schematic diagram of an example of such an attachment mode. The fabric strip 230 is sewn to the scallop line of the leaflet 250 via scallop stitch line 256, as well as scallop stitch line 254. According to some embodiments, the scallop stitch line 256 extends through stitch holes 282 in the fabric strip 230. The opposite portion of the fabric strip 230 is attached to the strut 212 via a suture loop 270, which extends only through the fabric strip 230, e.g., through its stitch holes 284, and loops around the strut 212 without the leaflet 250 attached directly to the strut 212. According to some embodiments, the fabric strip 230 is at least partially looped around the strut 212 or covers at least two surfaces of the strut 212 (see example in FIG. 14).

[0054] Advantageously, attaching only the struts 212 to the fabric strips 230 via the suture loops 270 is a much easier process than similarly suturing the suture loops 270 through the leaflets 250, thereby simplifying the attachment process and reducing assembly time while requiring less skill from the assembler.

[0055] According to some embodiments, the fabric strip 230 may include a plurality of stitch holes 282 and stitch holes 284, as shown in the example of FIG. 15, where the stitch holes 282 are adapted to receive the stitch lines 256 and the stitch holes 284 are adapted to receive the suture loops 270.

[0056] According to some embodiments, the stitch holes 284 may be provided in a pattern that matches the strut pattern, such as a zigzag pattern (see FIG. 15).

[0057] Advantageously, providing the fabric 230 with pre-cut stitch holes 282, 284 following the pattern of the struts 212 provides greater precision in attaching the fabric 230 to either the scallops 250 or the struts 212, even when the struts are presented with challenging shapes.

[0058] According to some embodiments, the distance L between the stitch holes 282 and the respective stitch holes 284 is selected according to a desired distance between the scallop stitch line 256 and the suture loop 270. Advantageously, by separating the suture loop 270 passing through the fabric strip 230 and the scallop stitch line 256 passing through the leaflet 250, the distance L can be more easily controlled, e.g., designed to be large enough to act as a shock absorber, providing stress distribution therealong, while on the other hand being short enough to maintain a stable, properly positioned underlying structure for the leaflet 250.

[0059] A further advantage is that the fabric strip 230 does not function solely as an inner wall skirt portion between the leaflets 250 and the struts 212, but rather as a soft hinge connection.

[0060] Preferably, the fabric strips 230 can provide greater stretchability and stress relief during crimping or expansion of the frame 210 .

[0061] When a prosthetic valve is implanted, the systolic and diastolic cycles exert forces on the leaflets that can cause the leaflet suture loops to slide on the frame strut portions to which they are attached. The oscillatory motion of the loops can cause them to lose tension over time, thereby allowing them to slide more freely on their respective strut portions, risking wear and reduced durability of the loops.

[0062] To avoid this, some embodiments may include struts that include tapered strut sections. In such embodiments, some strut sections are tapered such that their width changes between a narrower width at one end of the section and a wider width at the opposite end of the section. Suture loops (or knots) connected to the tapered sections may slide along the section until their inner diameter matches the corresponding width of the section. The struts may be assembled with their wider ends facing the inflow direction of the frame. Preferably, the loops or knots slide along the section (e.g., toward the inflow) until they "self-lock" into place, meaning that the loops or knots engage the section so tightly that they prevent them from moving further along the section. If the loops lose any of their tightness over time, they will slide a little further along the section (e.g., toward the inflow) until they "self-lock" in a new position. Preventing movement of the loops along the section during contraction / expansion cycles reduces wear on the loops and increases durability.

[0063] FIG. 16 shows the attachment of the leaflets 350 to the struts 320, 320' of the frame 310 of the prosthetic valve. The leaflets are attached to the frame via two opposing commissures along their scalloped edges, for example via a skirt or fabric. Attachment to the struts 320, 320' is achieved by a series of suturing loops or knots (e.g., 330a, 330b, 330'a, 330'b). The struts 320, 320' include a number of portions (e.g., 322a, 322b, 322'a, 322'b) disposed between their ends 324, 324' and intermediate portions (e.g., 326a, 326b, 326'a, 326'b) disposed between each couple of adjacent portions in the strut. The ends and intermediate portions of the struts include openings through which the struts can be connected to each other, for example via fasteners such as pins passing through the openings to form joints. All strut portions may have a uniform width "w" along their length.

[0064] In the example of FIG. 16, the leaflets 350 are attached to the intersecting struts 320 and 320' and connected at their ends 324, 324' to form an apex. The visible portion of the strut 320 in FIG. 16 includes a portion 322a extending between the end 324 and the middle portion 326a, and a portion 322b extending between the middle portion 326a and the middle portion 326b. The visible portion of the strut 320' in FIG. 16 includes a portion 322'a extending between the end 324' and the middle portion 326'a, and a portion 322'b extending between the middle portion 326'a and the middle portion 326'b. The leaflets 350 are attached to the strut 320 via suture loops 330a disposed along portion 322a and via suture loops 330b disposed along portion 322b. Similarly, leaflet 350 is attached to strut 320' via suture loop 330'a disposed along portion 322'a and via suture loop 330'b disposed along portion 322'b. Lc denotes the distance between two opposing junctions of a cell of frame 310, e.g., the distance between the apex formed by intersecting ends 324, 324' and an opposing (e.g., perpendicular) junction (see FIG. 16).

[0065] The orientation of the leaflets changes between systole and diastole, and during diastole forces are exerted by the leaflets on the suture loops such that suture loops 330a, 330b tend to slide over portions 322a, 322b, respectively, in direction 392 (i.e., towards the inflow end of the valve), and suture loops 330'a, 330'b tend to slide over portions 322'a, 322'b, respectively, in direction 394. The oscillatory motion of the suture loops during the systole / diastole cycle poses the risk that the knots in the suture loops will lose tension over time, thereby allowing them to slide freely over portions of the struts.

[0066] FIG. 17 shows a cross-section of a strut 360 with a tapered portion 362 extending between intermediate portion 364a and intermediate portion 364b. Tapered portion 362 is provided with a varying width such that a width W1 at one end thereof adjacent intermediate portion 364a is greater than a width W2 at its opposite end adjacent intermediate portion 364b. According to some embodiments, all portions of strut 360 are provided as tapered portions 362. FIG. 18 shows a cross-section of strut 360 with three adjacent tapered portions 362a, 362b, and 362c, with suture loops 330 shown tied on tapered portion 362b. Suture loops 330 can slide over tapered portion 362b to the region where their inner diameters match the portion width. The increased width of the portion along the region between the location of the suture loops and intermediate portion 364a prevents suture loops 330 from sliding further in direction 394.

[0067] According to some embodiments, the shape of the struts with tapered sections provides a "self-locking" feature for the suture loops, where each suture loop 330 slides along the section 362 until it engages the section 362 too tightly at the corresponding location, preventing the suture loop 330 from moving any further in any direction. As the suture loop loses some of its tension over time, and as a result its inner diameter expands, it slides slightly further along the section and "self-locks" in its new position where the section 362 is slightly wider. Advantageously, the "self-locking" feature that prevents the suture loop 330 from moving along the tapered strut section 362 reduces wear on the loops 330 and improves their durability. According to some embodiments, the struts 360 are assembled to form a frame such that the wider portions of their sections 362 are directed toward the inflow end of the frame.

[0068] If the leaflets are attached to the frame struts via suture loops substantially parallel to the scallop suture line, while also attached to the frame via the commissures at their opposing side ends, changes in the diameter of the frame may result in elongation of the leaflets, with high stress concentrations along the suture loops. One solution to this problem is to attach each leaflet via a slidable suture loop to a strut with a suture loop substantially perpendicular to the scallop stitch line. However, problems remain with potential gaps that may form between the scalloped edges of the leaflets and the junctures of the frame cells formed along the struts to which they are attached, causing the leaflet edges to not return to their intended positions after deployment.

[0069] To address this issue, each leaflet may be attached to an intersecting strut along its scalloped edge via a slidable suture loop. In such an embodiment, each pair of suture loops may be attached to a portion of an intersecting strut, and each suture loop may be slidable on the strut to which it is attached between its distal and proximal junctions. During frame expansion, the suture loops are configured to slide along the respective struts toward the intersecting junction between such struts (specifically, the distal junction). While the struts are sliding toward the distal junction, they drag the scalloped edge of the leaflet along the same direction. This allows the scalloped edge of the leaflet to return to the same position as it was in the expanded, pre-crimped, or pre-compressed position.

[0070] Figures 19A - 20B illustrate a technique of attaching a valve tip to a strut that crosses a scallop line via a slide - type suture loop. Figure 19A shows a valve tip 450 attached to a frame 410. Figure 19B shows an enlarged view of region 19B of Figure 19A. Suture loops 470a, 470b, and 470c attach the valve tip 450 to struts 432, 434, and 436, respectively. As shown in Figure 19B, each suture loop 470 can slide along its respective strut and respond to the state and shape of the frame 410, as well as the forces acting thereon as a result of the structural configuration and attachment regions of the valve tip 450. Suture loop 470a is slidably movable between joints J5 and J6. Suture loop 470b is slidably movable between joints J3 and J4. Suture loop 470c is slidably movable between joints J1 and J2. In Figures 19A - 19B, suture loop 470c is disposed closer to one of the joints, namely J1, while suture loops 470b and 470a are disposed closer to the middle portion between their corresponding joints.

[0071] Figures 20A - 20B show two transition stages between a radially expanded frame (Figure 20A) and a radially slightly compressed frame (Figure 20B). The longitudinal distance Lc between two opposing joints of the cells of the frame increases from Lc1 to Lc2 such that Lc1 < Lc2. Suture loop 470a is slidably movable between joints J5 and J6, and suture loop 470b is slidably movable between joints J7 and J6. The positions of suture loops 470a and 470b change along the struts between their respective joints according to the changing frame diameter. As a result, when the frame is further compressed to a fully crimped state (not shown), the scalloped edge of the valve tip displaces towards joint J6 and away from joint J8, and a gap is formed between the scalloped edge of the valve tip and joint J8.

[0072] FIG. 21A is a close-up of the position of the suture loop 470 in the expanded state before crimping of the frame, where the suture loop 470 is adjacent to junction J3. FIG. 21B is a close-up of the position of the suture loop 470 after valve crimping and subsequent frame expansion. When the frame is crimped, the suture loop 470 tends to slide toward the junction closer to the valve outflow (i.e., toward junction J4 in the illustrated example). As shown in FIG. 21B, when the frame is expanded from the crimped state, the suture loop does not return to its original position in FIG. 21A, but rather is positioned significantly away from junction J3. As a result, the scalloped edge of the valve leaflet is positioned closer to the valve outflow relative to its original position before crimping.

[0073] 22A-23D show an attachment configuration of the skirt to the prosthetic frame, which is configured to help return the scalloped edges of the leaflets to their pre-crimped state upon expansion, as shown in FIG. 21BA. FIGS. 22A and 22B show a prosthetic frame 510 with a skirt 520 attached to its struts. FIGS. 22A and 22B show the attachment of the skirt 520 to the frame 510 from the inner and outer viewing angles of the frame 510, respectively. The skirt 520 is attached to the intersecting struts via suture loops. FIG. 22A shows two such suture loops 542 and 544, attaching portions of the skirt 520 to struts 552 and 554, respectively. The suture loops may be connected via strings (not individually numbered) forming the ends of the strings sutured to the two intersecting struts. Struts 552 and 554 constitute two edges of one cell of frame 510, intersecting at junction J2. The suture loops are not too tightly attached to the struts, but rather are loose enough to allow them to slide along their respective struts. Suture loop 542 is slidably movable along strut 552 between junctions J1 and J2. Suture loop 544 is slidably movable along strut 554 between junctions J3 and J2.

[0074] 23A-23D show different transition stages between a radially compressed frame (FIG. 23A) and a radially expanded frame (FIG. 23D). The suture loops 542 and 544 are slidably movable along the respective struts to which they are attached, such that their positions change according to the changing frame diameter. As the frame expands, it can be seen that the suture loops 542 and 544 slide toward the intersecting joint J2 between their respective struts, dragging the skirt edge 522 along with it. Specifically, when the frame is compressed (FIG. 22A), e.g., during the crimping stage, the skirt edge 522 is shown spaced apart from the joint J2, whereas the skirt edge 522 aligns with the joint J2 in the expanded state (FIG. 23D), preventing gap formation between the joint J2 and the skirt edge 522.

[0075] According to one aspect of the technology, a method is provided in which each leaflet of a prosthetic valve is attached to an intersecting strut via a slidable suture loop along its scalloped edge. The prosthetic valve may include multiple leaflets (not shown) each attached to a frame along or near its scalloped edge via two opposing commissures. FIG. 24 shows suture loops 642 and 644 attached to the leaflets. As can be seen, as opposed to the attachment areas shown in FIG. 22A for skirt 520, suture loops 642 and 644 are slidably movable along struts opposite the struts utilized in FIG. 22A in each cell. Specifically, suture loops 642 and 644 are attached to and slidably movable along struts 656 and 658 instead of struts 652 and 654 that may have been utilized to attach the skirt. Suture loops 642 and 644 are similar in structure and function to suture loops 542 and 544. For example, suture loop 644 is slidably moveable along strut 658 between junctions J3 and J4.

[0076] As the frame expands, the suture loops 442 and 444 are configured to slide toward and drag the scalloped edges of the leaflets along the intersecting junction J3 between the respective struts 656. Specifically, while the scalloped edges move away from junction J3 when the frame is compressed, the frame aligns with junction J3 in the expanded state, similar to the pre-crimp position of FIG. 21A, preventing the formation of a gap between junction J3 and the scalloped edges of the leaflets.

[0077] A significant advantage of the disclosed technique is the ability to use a sliding scallop line during the crimping phase (as shown in Figures 19A-20B) while ensuring that the leaflet scallop line is correctly positioned after deployment.

[0078] General Considerations The embodiments disclosed herein can be adapted for delivery and implantation of prostheses into any of the heart's native annulus (e.g., aortic, pulmonary, mitral, and tricuspid annulus) and can be used with any of a variety of delivery devices for delivery of prosthetic valves using any of a variety of delivery approaches (e.g., retrograde, antegrade, transseptal, transventricular, transatrial, etc.). The prosthetic heart valve can be radially collapsed during delivery through the body and then radially expanded at the implantation site, such as by using a delivery device coupled to the valve. The valves and other implantable devices disclosed herein can be delivered using catheters and / or guidewires. The guidewire can be advanced through the patient and then a catheter can be advanced over the guidewire. The catheter can have an innermost shaft that defines a guidewire lumen through which the guidewire passes. The catheter can be part of a delivery system that can include multiple catheters, shafts, and / or sheaths, actuation mechanisms, power mechanisms, and other components. For example, the delivery device can include an actuation mechanism that mechanically expands a frame at the implantation site.

[0079] For purposes of this description, certain aspects, advantages, and novel features of the disclosed embodiments are described herein. The disclosed methods, devices, and systems should not be construed as limiting in any manner. Instead, the disclosure is directed to all novel and non-obvious features and aspects of the various disclosed embodiments, both alone and in various combinations and subcombinations with one another. The methods, devices, and systems are not limited to any particular aspect or feature or combination thereof, and the disclosed embodiments do not require that any one or more particular advantages exist or problems be solved. Technology from any example can be combined with technology described in any one or more other examples. In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples and should not be construed as limiting the scope of the disclosed technology.

[0080] Although some operations of the disclosed embodiments are described in a particular sequential order for convenient presentation, it should be understood that the method of description includes rearrangements unless a particular order is required by specific language described herein. For example, operations described in a sequence may be rearranged or performed simultaneously in some cases. Furthermore, for simplicity, the accompanying figures may not show the various ways in which the disclosed methods can be used in combination with other methods. Furthermore, the description may use terms such as "provide" or "achieve" to describe the disclosed methods. These terms are high-level abstractions of actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by those of ordinary skill in the art.

[0081] As used in this application and the claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise. Additionally, the term "include" means "comprise." As used herein, "and / or" means "and" or "or," as well as "and" and "or." Additionally, the terms "coupled" and "connected" generally mean physically (e.g., mechanically or chemically), electrically, and / or magnetically coupled or linked, and do not exclude the presence of intermediate elements between coupled or related items absent specific language to the contrary.

[0082] Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate discussion of the figures and principles herein, but are not intended to be limiting. For example, specific terms such as "inside," "outside," "top," "down," "interior," "exterior," etc. may be used. Such terms are used, where applicable, to provide some clarity of explanation when dealing with relative relationships, particularly with respect to the illustrated embodiments. However, such terms are not intended to imply absolute relationships, positions, and / or orientations. For example, with respect to an object, a "top" part can become a "bottom" part simply by flipping the object over. Nevertheless, it is still the same part and the object remains the same.

[0083] The valves and frames disclosed herein are described using an axial direction defined by the centerline of the annular frame and the general direction of blood flow from the inflow end to the outflow end, a radial direction defined as radiating orthogonally from the centerline of the frame, and a circumferential direction orthogonal to the axial and radial directions and extending around the centerline of the frame. The term "inner" refers to objects, surfaces, and areas closer to the centerline of the frame, and the term "outer" refers to objects, surfaces, and areas further from the centerline of the frame.

[0084] In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are merely preferred examples of the technology and should not be considered as limiting the scope of the technology. Rather, the scope of the disclosed technology is at least as broad as the following claims and their equivalents. [Explanation of symbols]

[0085] 10, 110, 210, 310, 410, 510 frames 12, 112 cells 22, 24, 30, 32, 34, 36, 42, 44, 46, 212, 320, 320', 360, 432, 434, 436, 552, 554, 652, 654, 656, 658 Strut 26, 28 Strut joint 50 Scallop 50, 50a, 50b, 150, 150a, 150b, 150c, 250, 250a, 250b, 350, 450 leaflets 52, 52a, 52b, 152, 152a, 152b, 252, 252a, 252b commissure 54, 154, 154a, 154b, 254, 254a, 254b, 256 Scallop stitch lines 60, 70, 70a, 70b, 70c, 70d, 70e, 70f, 70g, 70h, 70i, 116, 170, 260, 270, 330, 330a, 330'a, 330b, 330'b, 442, 444, 470, 470a, 470b, 470c, 542, 544, 642, 644 Suture Loop 70 Sutures 80 Open-mouthed couple 90 aperture 130 Inner Skirt 140 Scallop line foundation structure 140, 140a, 140b, 140c Scallop line elements 142, 324, 324' end 144 Central part 154 Scalloped suture line 230 Cloth, Cloth Strips 232 First Cloth 234 Second Cloth 282, 284 Stitch holes 322a, 322b, 322'a, 322'b part 326a, 326b, 326'a, 326'b, 364a, 364b middle part 330a, 330b, 330'a, 330'b knots 362, 362a, 362b, 362c tapered part 392, 394 direction 520 Skirt 522 Skirt Edge J1, J2, J3, J4, J5, J6 joints L distance Lc, Lc1, Lc2, Lc3, Lc4, Lc5, Lc6 Distance between joints w width 2B area

Claims

1. 1. A prosthetic heart valve comprising: a radially expandable and foldable annular frame including a plurality of intersecting struts joined together at pivot joints, wherein radial expansion or contraction of the annular frame causes the intersecting struts to pivot relative to one another at the pivot joints; a valvular structure mounted within the frame and regulating blood flow through the prosthetic heart valve, the valvular structure including valve leaflets; the leaflets are coupled to the frame at their lateral commissure ends and along scalloped edges of the leaflets extending between the lateral commissure ends; the scalloped edge of the leaflet is coupled to the strut portion of the frame via a suture loop, the strut portion to which the suture loop is coupled being oriented across the scalloped edge of the leaflet. Artificial heart valve.

2. 2. The prosthetic heart valve of claim 1, wherein the scalloped edges of the leaflets are coupled to the strut portions oriented across the scalloped edges, allowing the scalloped edges to move relative to the strut portions via the suture loops that slide along the strut portions during radial expansion and compression of the frame.

3. 3. The prosthetic heart valve of claim 1 or claim 2, wherein anatomical forces acting on the leaflets along the scalloped edges at their attachment points to the strut components during systole and diastole are perpendicular to the suture loops, thereby inhibiting undesired wear of the suture loops and the leaflets.

4. 4. The prosthetic heart valve of claim 1, wherein the scalloped edge of each leaflet is connected to at least six different strut components of the frame via suture loops.

5. 5. The prosthetic heart valve of claim 4, wherein the at least six distinct strut portions include three parallel strut portions on one side of the scalloped edge and another three parallel strut portions on a second side of the scalloped edge.

6. 6. The prosthetic heart valve of claim 1, wherein the strut components to which the suture loops are attached are oriented perpendicular to the scalloped edges of the leaflets.

7. 7. The prosthetic heart valve of claim 1, further comprising a scallop line substructure including three scallop line elements, each of the three scallop line elements attached to a scalloped edge of one of the leaflets.

8. 8. The prosthetic heart valve of claim 1, wherein a scallop line element is formed of a rigid material, such as a metal or metal alloy, and is elastically deformable to resist radially inward displacement of the scalloped edges of the leaflets.

9. 8. The prosthetic heart valve of claim 1, wherein the scallop line element is formed of a soft material such as a short skirt, fabric, cable, or string.

10. 10. The prosthetic heart valve of claim 7, wherein the scallop line elements have flexibility that allows a central portion of the scallop line elements to deform from a generally U-shape to a generally V-shape during radial compression of the frame while the ends of the scallop line elements move toward each other.

11. 11. The prosthetic heart valve of claim 1, wherein each strut of the frame is pivotally coupled to three or more other struts of the frame at respective mechanical pivot joints such that the struts can pivot relative to one another without deformation.

12. 12. The prosthetic heart valve of claim 11, wherein each strut includes at least three strut portions, each strut portion extending between two adjacent mechanical pivot joints.

13. 13. The prosthetic heart valve of claim 1, wherein the strut portions are tapered such that the width of the strut portions decreases from the inflow end of the frame to the outflow end of the frame.

14. 14. The prosthetic heart valve of claim 13, wherein the leaflets are coupled to the tapered strut portions via suture loops such that the suture loops that extend around the tapered strut portions are large enough to fit around narrow ends of the tapered strut portions, but small enough not to fit around wide ends of the tapered strut portions.

15. the suture loop slides along a tapered portion of the strut from the narrow end to the wide end; and 15. The prosthetic heart valve of claim 14, wherein the circumference of the suture loop is equal to the circumference of the tapered strut portion and is configured to frictionally self-lock at an intermediate location along the tapered strut portion.

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