Prosthetic heart valve

Abstract

This application relates to prosthetic heart valves. Disclosed are embodiments of a radially collapsible and expandable prosthetic heart valve. The valve frame can have a tapered profile when mounted on a delivery shaft, with a smaller diameter at the inflow end portion than at the outflow end portion. The valve can include generally V-shaped leaflets, reducing the amount of material in the inflow end of the frame. An outer skirt can be secured to the outside of the inflow end portion of the frame, with longitudinal slack when the valve is expanded and lying flat against the frame when the valve is collapsed. An angularly woven inner skirt can be axially elongated with the frame. Side tabs adjacent the leaflets can extend through and be secured to window frame portions of the frame to form commissures. The window frame portions can be recessed radially inward relative to the surrounding frame portions when the valve is crimped on a delivery shaft.

Description

[0001] This application is a divisional application, based on a further divisional application with application number 202210076714.5. This further divisional application is based on a divisional application with application number 201810800907.4, which in turn is based on a divisional application with application number 201510850059.4. The original divisional application was filed on October 5, 2011, with Chinese application number 201180058439.4 and international application number PCT / US2011 / 054973, entitled "Artificial Heart Valve," the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0002] This disclosure relates to embodiments of artificial heart valves and delivery systems for transplanted heart valves. Background Technology

[0003] The human heart can suffer from various valvular diseases. These diseases can lead to serious heart dysfunction and eventually require the replacement of natural valves with artificial ones. There are many known artificial valves and many known methods for transplanting these artificial valves into humans.

[0004] Various surgical techniques can be used to replace or repair diseased or damaged valves. Each year, thousands of patients undergo surgery to replace defective natural heart valves with artificial ones due to stenosis and other heart valve diseases. Another less drastic approach to treating defective valves is through repair or reconstruction, typically used on valves with minimal calcification. The problem with surgical treatment is the significant risk of morbidity and mortality associated with surgical repair imposed on these patients with chronic conditions.

[0005] When replacing a natural valve, surgical transplantation of an artificial valve typically requires open-heart surgery, during which the heart stops and the patient is placed on a cardiopulmonary bypass machine (also known as a "heart-lung machine"). In a routine procedure, the diseased leaflet of the natural valve is removed and the artificial valve is sutured to the surrounding tissue at the valve annulus. Due to the damage associated with the procedure and the duration of extracorporeal circulation, some patients do not survive the surgery or die shortly thereafter. It is well known that the patient's risk increases with the amount of time required for extracorporeal circulation. Because of these risks, a large number of patients with defective valves are considered unsuitable for surgery because their condition is too frail to withstand the procedure. By some estimates, more than 50% of patients over 80 years of age suffering from valvular stenosis are not candidates for valve replacement surgery.

[0006] Percutaneous and minimally invasive surgical approaches have gained significant attention due to the drawbacks associated with conventional open-heart surgery. In one technique, an artificial valve is configured for implantation via catheter insertion in a much less invasive procedure. For example, compressible transcatheter heart valves, which can be percutaneously introduced onto a catheter in a compressed state and inflated by a balloon or expanded at the desired location using a self-expanding frame or stent, are described by reference herein.

[0007] A crucial design parameter for transcatheter heart valves is the diameter of the folded or pleated profile. The diameter of the pleated profile is important because it directly affects the physician's ability to guide the transcatheter heart valve through the femoral artery or vein. More specifically, a smaller profile allows for the treatment of a larger number of patients with enhanced safety. Summary of the Invention

[0008] This disclosure relates to methods and apparatuses, delivery devices, and kits of heart valves mounted on delivery devices in connection with artificial valves such as heart valves.

[0009] An exemplary embodiment of a kit for implanting an artificial heart valve in a patient includes a delivery device comprising an elongated shaft and a radially expandable artificial heart valve mounted on the shaft in a radially contractile configuration for delivery into the body. The artificial heart valve includes an annular frame having an inlet portion and an outlet portion, and leaflet structures located within the frame. The outer diameter of the inlet portion of the frame is smaller than the outer diameter of the outlet portion of the frame. The reduced diameter at the inlet may be due to a reduced amount of material within the inlet portion of the frame. This reduced diameter at the inlet portion allows space for an outer skirt located around the inlet portion.

[0010] In some embodiments, the heart valve may further include an outer skirt disposed around the outer surface of the inlet portion of the frame, such that the outer diameter of the inlet portion of the artificial valve—including the outer skirt—remains less than or equal to the outer diameter of the outlet portion of the artificial valve.

[0011] In some embodiments, the leaflet structure may include a plurality of leaflets, each including opposing side protrusions on opposite sides of the leaflet. The side protrusions may be secured to an outflow end portion of the frame. Each leaflet may further include a free outflow edge portion extending between the side protrusions adjacent to the outflow end of the frame; and an inflow edge portion extending between the side protrusions adjacent to the inflow end of the frame. The inflow edge portions may include opposing axial edge portions extending from the side protrusions toward the inflow end in a generally axial direction; and intermediate edge portions extending between the axial edge portions. The intermediate edge portions may include a curved tip portion adjacent to the inflow end of the frame, and a pair of inclined portions extending between the axial edge portions and the tip portion. The inclined portions may have a larger radius of curvature than the tip portions, forming a generally V-shaped leaflet.

[0012] In some embodiments, the frame includes a plurality of angledly spaced syndesm windows, each including a closed opening between first and second axially oriented lateral struts. In these embodiments, the leaflet structure includes a plurality of leaflets, each including two opposing lateral protrusions, each lateral protrusion mating with an adjacent lateral protrusion of a neighboring leaflet to form a syndesm of the leaflet structure. Each syndesm extends radially outward through a corresponding syndesm window of the frame to a location outside the frame and is sutured to a lateral strut of the syndesm window. In some of these embodiments, when the artificial valve is of a contractile configuration on the axial direction, the syndesm windows of the frame are radially recessed inward relative to the frame portion extending between adjacent syndesm windows.

[0013] In some embodiments, the frame includes an inflow row opening at the inflow end portion of the frame, an outflow row opening at the outflow end portion of the frame, and at least one intermediate row opening between the inflow row opening and the outflow row opening. The opening of the inflow row opening is larger than the opening of the at least one intermediate row opening.

[0014] In some implementations, when the structure is a contraction configuration on the shaft, portions of the leaflet structure protrude through openings in the frame.

[0015] In some implementations, the inflow portion of the frame includes a frame thickness that is less than the frame thickness of the intermediate portion of the frame between the inflow and outflow portions.

[0016] The embodiments disclosed herein may include a transplantable artificial valve that can radially contract to a contractile configuration and radially expand to an expandable configuration. Such an artificial valve may include an annular frame, leaflet structures located within the frame, and an annular outer skirt located around the outer surface of the frame. The outer skirt may include an inflow edge fixed to the frame in a first location, an outflow edge fixed to the frame in a second location, and an intermediate portion between the inflow and outflow edges. When the valve is in an expandable configuration, the intermediate portion of the outer skirt includes a relaxation portion along the axial direction between the inflow and outflow edges of the outer skirt, and when the valve contracts to a contractile configuration, the axial distance between the inflow and outflow edges of the outer skirt increases, reducing the axial relaxation portion in the outer skirt.

[0017] In some of these embodiments, the outer skirt does not extend in the axial direction when the valve radially contracts to the contraction structure and the relaxation portion is eliminated from the middle portion of the outer skirt.

[0018] Some embodiments of transplantable artificial valves include a ring-shaped frame comprising a plurality of leaflet attachment portions; and leaflet structures located within the frame and fixed to the leaflet attachment portions of the frame. The leaflet structures include a plurality of leaflets, each leaflet comprising a main portion, two opposing major projections extending from opposite sides of the main portion, and two opposing secondary projections extending from the main projections adjacent to the major projections. The secondary projections are folded around radially extending creases such that a first portion of the secondary projection rests flat against the main portion of its respective leaflet, and the secondary projections are folded around axially extending creases such that a second portion of the secondary projection extends in a plane different from the first portion. The second portion of each secondary projection is sutured to its respective major projection, and the secondary projections are located within the frame.

[0019] In some of these embodiments, when the valve contracts to a radially contracting configuration, a first portion of each subprotrusion pivots about an axially extending crease and rests flat against a second portion of the subprotrusion. The first portion of each subprotrusion includes an inner edge radially spaced from the inner surface of the frame, and when the valve is operated on in a patient, in response to blood flowing through the valve, the main body portion of the leaflet pivots around the inner edges of the two subprotrusions of the leaflet.

[0020] Some embodiments disclosed herein include a transplantable artificial valve that can radially contract to a contractile configuration and radially expand to an expandable configuration. The artificial valve includes an annular frame having an inflow portion and an outflow portion, leaflet structures located within the frame, and an annular inner skirt located within the frame. The inner skirt is fixed to the inside of the frame and includes fabric comprising a first set of threads and a second set of threads, neither of which are parallel to the axial direction of the valve. When the valve contracts from the expandable configuration to the contractile configuration, the axial length of the frame increases, and both the first and second sets of threads rotate in the axial direction of the valve, causing the inner skirt to elongate axially along with the frame.

[0021] In some of these embodiments, when the valve is inflatable, the first set of threads is substantially perpendicular to the second set of threads. In some embodiments, the first set of threads forms a first angle with the axial direction of the valve, and the second set of threads forms a second angle with the axial direction of the valve, the first and second angles being substantially equal. In some of these embodiments, the first and second sets of threads comprise 20 denier yarns.

[0022] Some embodiments of the implantable artificial valve include a radially constrictible and expandable annular frame comprising a plurality of angledly spaced syndesm windows, each including a closed opening between first and second axially oriented lateral struts. The valve also includes leaflet structures located within the frame and comprising a plurality of leaflets, each leaflet including two opposing lateral projections. Each lateral projection mates with an adjacent lateral projection of a neighboring leaflet to form a syndesm of the leaflet structure. Each pair of lateral projections extends radially outward through the corresponding syndesm window to a location outside the frame, with portions of the projections outside the frame extending circumferentially away from each other and along the outer surface of the lateral struts. The valve further includes a plurality of wedges, each wedge located between the lateral struts of the syndesm windows and separating the pairs of lateral projections extending through the syndesm windows, the wedges being forced radially inward against the lateral projections.

[0023] The wedge-shaped portion can extend in the axial direction, and its axial length matches the axial length of the side pillars of the connecting window. The wedge-shaped portion can further restrict the rotational movement of the side protrusions relative to the connecting window. Each wedge-shaped portion can be sewn to a flexible reinforcing sheet, which is also sewn to each pair of side protrusions, and each can be sewn to the pair of side protrusions. The wedge-shaped portion may include a non-metallic material, such as a stitching material.

[0024] The above and other objects, features and advantages of the present invention will become clearer from the following detailed description, with reference to the accompanying drawings. Attached Figure Description

[0025] Figure 1-3 An exemplary implementation of an artificial heart valve is shown.

[0026] Figure 4-10 show Figure 1 An exemplary framework for a heart valve.

[0027] Figure 11-15B Another exemplary frame for an artificial heart valve is shown.

[0028] Figures 16A and 16B show Figure 1 An exemplary inner skirt of a heart valve.

[0029] Figure 17 Another embodiment of an artificial heart valve showing frame deformation under compression (folding) conditions.

[0030] Figure 18 The display shows that it is in a compressed state and is mounted on an exemplary balloon catheter. Figure 1 The heart valves.

[0031] Figure 19-20 shows Figure 16A The inner skirt and Figure 4 A suite of frameworks.

[0032] Figure 21-28 Showing an example leaflet structure of the kit.

[0033] Figures 29-35 The kit that displays the connecting part of the leaf structure and the window frame part of the frame.

[0034] Figure 36-40 Showing the leaflet structure and inner skirt kit along the lower edge of the leaflet.

[0035] Figure 41 This shows an exemplary outer skirt that unfolds outwards.

[0036] Figure 42 and 43 show Figure 1 An exemplary artificial heart valve.

[0037] Figures 44-48 This illustrates an alternative implementation of an artificial heart valve.

[0038] Figures 49-52 Part of the display frame's alternative implementation.

[0039] Figure 53 This indicates a state of radial compression. Figure 4 The framework part.

[0040] Figure 54 show Figure 4 The cross-sectional profile of the frame shows that it tapers roughly from the outflow end to the inflow end.

[0041] Figure 55Displaying an unfolded, flat structure Figure 4 The framework.

[0042] Figure 56 The display shows that it is in a compressed state and is mounted on an exemplary balloon catheter. Figure 1 The heart valves.

[0043] Figure 57 and 58 This illustrates an implementation of a leaflet with a generally V-shaped structure.

[0044] Figure 59 A cross-sectional view showing an alternative embodiment of an artificial valve with a variable thickness frame.

[0045] Figure 60 This is a side view of an embodiment of a valve frame having a connecting window before the leaflet structure is installed to the frame.

[0046] Figure 60A yes Figure 60 An enlarged side view of a connecting window.

[0047] Figure 61 It includes Figure 60 A perspective view of an embodiment of an artificial valve with a frame and leaflet structure installed on the valve.

[0048] Figure 62 yes Figure 61 An enlarged side view of one of the commissures of the valve.

[0049] Figure 63-71 yes Figure 61 A cross-sectional view of the commissure of the valves, showing various techniques for suturing a pair of leaflet-side protrusions to the commissure window using reinforcing strips.

[0050] Figures 72-74 The display frame is used for an alternative embodiment of an airbag inflation for an artificial valve having inflow and outflow portions with reduced thickness. Detailed Implementation

[0051] According to one implementation method Figure 1-3 Various views of the artificial heart valve 10 are shown. The illustrated valve is suitable for implantation in the natural aortic rings, although in other embodiments it may be suitable for implantation in other natural rings of the heart. The valve 10 may have four main components: a stent or frame 12, a valve structure 14, an inner skirt 16, and an outer skirt 18.

[0052] Valve structure 14 may include three leaflets 400 that together form a leaflet structure, which may be arranged in a collapsed configuration similar to a tricuspid valve, such as... Figure 2The optimal display is achieved by considering the lower edge of the leaflet structure 14, which ideally has a wavy, curved fan shape. Figure 1 The suture 154 shown follows the fan-shaped shape of the leaflet structure. By forming leaflets with this fan-shaped geometry, stress on the leaflets is reduced, which in turn improves valve durability. Moreover, due to the fan-shaped shape, creases and ripples in the middle of each leaflet (the central region of each leaflet) can be eliminated or at least minimized, as these creases and ripples can cause early calcification in those areas. The fan-shaped geometry also reduces the amount of tissue material used to form the leaflet structure, thereby allowing for a smaller, flatter pleated profile at the valve inflow end. The leaflet 400 may be formed from 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 U.S. Patent No. 6,730,118, which is incorporated herein by reference.

[0053] Exposed frame 12 is shown Figure 4 The frame 12 may consist of a plurality of circumferentially spaced apertures or connecting windows 20 (three in the illustrated embodiment) adapted to mount the connecting portion of the valve structure 14 to the frame, as described in more detail below. The frame 12 may be made of any of a variety of suitable plastically expandable materials (e.g., stainless steel, etc.) or self-expanding materials (e.g., nitinol) known in the art. When constructed of a plastically expandable material, the frame 12 (and therefore the valve 10) may be folded into a radially compressed state on the delivery catheter and then inflated within the patient by an inflatable balloon or equivalent expansion mechanism. When constructed of a self-expanding material, the frame 12 (and therefore the valve 10) may be folded into a radially compressed state and held in a compressed state by a sheath or equivalent mechanism inserted into the delivery catheter. Once in the body, the valve may advance from the delivery sheath such that the valve expands to its functional size.

[0054] Suitable plastic expansion materials that can be used to form the frame 12 include, but are not limited to, stainless steel, nickel-based alloys (e.g., cobalt-chromium alloys or nickel-cobalt-chromium alloys), polymers, or combinations thereof. In a specific embodiment, the frame 12 is composed of a nickel-cobalt-chromium-molybdenum alloy such as MP35N™ (a trademark of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum by weight. It has been found that using MP35N to form the frame 12 provides superior structural effects compared to stainless steel. Specifically, when MP35N is used as the frame material, less material is required to achieve the same or better performance in terms of resistance to radial and compressive forces, fatigue resistance, and corrosion resistance. Moreover, because less material is required, the frame pleat profile can be reduced, thereby providing a smaller profile valve kit for percutaneous delivery to the treatment site within the body.

[0055] refer to Figure 4 and 5 The frame 12 in the illustrated embodiment includes angled pillars 22 of a first lower row I, arranged end-to-end and extending circumferentially at the inflow end of the frame; angled pillars 24 of a second row II extending circumferentially; angled pillars 26 of a third row III extending circumferentially; angled pillars 28 of a fourth row IV extending circumferentially; and angled pillars 32 of a fifth row V extending circumferentially at the outflow end of the frame. A plurality of substantially straight axially extending pillars 34 are used to interconnect the pillars 22 of the first row I and the pillars 24 of the second row II. The angled pillars 32 of the fifth row V are connected to the angled pillars 28 of the fourth row IV by a plurality of axially extending window frame portions 30 (which define the connecting window 20) and a plurality of axially extending pillars 31. Each axial pillar 31 and each frame portion 30 extends from a position defined by the intersection of the lower ends of two angled pillars 32 to another position defined by the intersection of the upper ends of two angled pillars 28. Figure 6 , 7 8, 9 and 10 are respectively Figure 5 An enlarged view of the portion of frame 12 represented by the letters A, B, C, D, and E.

[0056] Each ferrule window frame portion 30 houses its respective ferrule of the leaflet structure 14. Each frame portion 30 is secured at its upper and lower ends to struts in an adjacent row to provide a robust structure, enhancing fatigue resistance under cyclic loading of the valve compared to known cantilever struts used to support ferrules of the leaflet structure. This construction allows for a reduction in frame wall thickness to achieve a smaller pleated diameter of the valve. In a specific embodiment, the thickness T of the frame 12, measured between the inner and outer diameters, is... Figure 4 The diameter is approximately 0.48 mm or smaller.

[0057] The supports and frame sections together define multiple open meshes of the frame. At the inlet end of frame 12, supports 22, 24, and 34 define the lower row of meshes, defining opening 36. Supports 24, 26, and 28 of the second, third, and fourth rows define two middle rows of meshes, defining opening 38. Supports 28 and 32 of the fourth and fifth rows, together with frame section 30 and support 31, define the upper row of meshes, defining opening 40. Opening 40 is relatively large and sized such that when frame 12 is pleated, a portion of leaf structure 14 protrudes or bulges into and / or through opening 40 to minimize the pleating profile.

[0058] like Figure 7In the optimal configuration, the lower end of the support column 31 connects to two supports 28 at node or joint 44, and the upper end of the support column 31 connects to two supports 32 at node or joint 46. The thickness S1 of the support column 31 may be less than the thickness S2 of the joints 44 and 46. Figure 53 This shows a portion of frame 12 in a pleated state. Joints 44 and 46, together with joint 64, prevent opening 40 from being completely closed. Figure 18 The valve 10 is shown folded over the balloon duct. It is evident that the geometry of the strut 31 and the junctions 44, 46, and 64 contribute to creating sufficient space within the folded opening 40 to allow portions of the leaflet to protrude (i.e., bulge) outward through the opening. This results in a relatively smaller diameter folded valve compared to the assumption that all leaflet material is confined within the folded frame.

[0059] Frame 12 is configured to prevent or at least minimize possible over-inflation of the valve under a predetermined balloon pressure, particularly at the outflow portion of the frame supporting the leaflet structure 14. In one aspect, the frame is configured to have relatively large angles 42a, 42b, 42c, 42d, and 42e between the struts. The larger the angle, the greater the force required to open (inflate) the frame. This phenomenon is schematically illustrated in… Figure 15A and 15B middle. Figure 15A This illustrates the struts 32 when the frame 12 is in its compressed state (e.g., mounted on an airbag). When the frame is compressed, the vertical distance d1 between the strut ends is at its maximum, while a relatively large torque between forces F1 and F2 acting on the strut ends is provided in the opposite direction when an opening force is applied from the inflation of the airbag (or inflation from another inflation device). When the frame expands radially, the vertical distance between the strut ends decreases to a distance d2, as... Figure 15B As depicted, as the vertical distance decreases, the moment between forces F1 and F2 also decreases. Therefore, it is evident that as the vertical distance and moment between the strut ends decrease, a relatively larger expansion force is required. Furthermore, as the frame expands, strain hardening (stiffening) at the strut ends increases, which increases the expansion force required to induce further plastic deformation at the strut ends. Thus, the angles between the struts of the frame can be selected to limit the radial expansion of the frame at a given opening pressure (e.g., the inflation pressure of an airbag). In specific embodiments, these angles are at least 110 degrees or greater when the frame expands to its functional dimensions, and more specifically, at least 120 degrees or greater when the frame expands to its functional dimensions.

[0060] Furthermore, due to the "dumbbell" effect of the balloon used to inflate the valve, the inflow and outflow ends of the frame typically tend to over-inflate compared to the middle portion of the frame. To avoid over-inflation of the leaflet structure 14, it is desirable to secure the leaflet structure to the frame 12 below the upper row of struts 32, as follows: Figure 1The best display. Figure 55 Display and Figure 5 A similar plan view of frame 12 is shown, but with lines 176 superimposed on the frame to indicate the position of the upper edge of the leaflet 400. Therefore, in the event of excessive expansion at the outflow end of the frame, the leaflet structure is positioned below a level where excessive expansion might occur, thus preventing excessive expansion of the leaflet structure.

[0061] In known valve configurations, if the leaflet is installed too close to the distal end of the frame, it can protrude outward beyond the outflow end of the frame when the valve is folded. If the delivery catheter with the folded valve includes a pusher or stop element that pushes against or abuts the outflow end of the valve (e.g., to maintain the position of the folded valve on the delivery catheter), the pusher or stop element may damage the exposed leaflet extending beyond the outflow end of the frame. Another advantage of installing the leaflet at a position spaced apart from the outflow end 178 of the frame is that when the valve is folded onto the delivery catheter, as... Figure 56 As shown, the leaflet 400 does not protrude axially beyond the outflow end 178 of the frame. Thus, if the delivery catheter includes a push mechanism or stop element that pushes against or abuts the outflow end of the valve, the push mechanism or stop element can contact the end 178 of the frame, rather than the leaflet 400, thereby avoiding damage to the leaflet.

[0062] Moreover, in Figure 5 As can be seen, the opening 36 in the bottom row of the frame is relatively larger than the openings 38 in the two middle rows. Figure 54 As shown, when folded, this allows the frame to have an overall tapered shape, tapering from a maximum diameter D1 at the valve outflow end to a minimum diameter D2 at the valve inflow end. When folded, the frame 12 has a region with a reduced diameter extending along the frame portion adjacent to the frame inflow end indicated by reference numeral 174, which roughly corresponds to the frame region covered by the outer skirt 18. The diameter of region 174 is reduced compared to the diameter of the upper part of the frame (not covered by the outer skirt), so that the outer skirt 18 does not increase the overall folded shape of the valve. When the valve unfolds, the frame can expand to... Figure 4 The cylindrical shape shown. In one example, when pleated, the frame of the 26mm valve has a diameter D1 of 14 French at the valve outflow end and a diameter D2 of 12 French at the valve inflow end.

[0063] Figure 11 and 12An optional frame 50 is shown that can be incorporated into the valve 10. The frame 50 includes multiple rows of circumferentially extending, angled struts 52 connected to each other at nodes or connecting portions 54 and 56. The uppermost row of struts 52 is connected to the struts of adjacent rows via multiple axially extending struts 58 and merging window frame portions 60. Each merging frame portion 60 defines an aperture or merging window 62 for mounting a respective merging portion of the valve structure, as described in more detail below. In a specific embodiment, the thickness T of the frame 50 is approximately 0.45 mm or less. Figure 13 and 14 yes Figure 12 Enlarged view of the frame portion 50, represented by the letters A and B respectively.

[0064] The primary function of the inner skirt 16 is to help secure the valve structure 14 to the frame 12 and to help form a good seal between the valve and the natural ring by blocking blood flow through the open mesh of the frame 12 below the lower edge of the leaflet. The inner skirt 16 preferably comprises a tough, tear-resistant material, such as polyethylene terephthalate (PET), although various other synthetic or natural materials may be used. The skirt thickness is preferably less than 6 mils, and preferably less than 4 mils, and even more preferably about 2 mils. In specific embodiments, the skirt 16 may have a variable thickness; for example, the skirt may be thicker at its edges than at its center. In one embodiment, the skirt 16 may comprise a PET skirt with a thickness of about 0.07 mm at its edges and about 0.06 mm at its center. A thinner skirt provides better pleating properties while still providing a good seal around the valve.

[0065] Skirt 16 can be secured to the inside of frame 12 via seam thread 70, such as Figure 39 As shown in the diagram. Valve structure 14 can be attached to the skirt via one or more thin PET reinforcing bands 72 (which together form a liner), as discussed below, ensuring reliable suturing and preventing tearing of the lobular pericardial tissue. Valve structure 14 can be sandwiched between the skirt 16 and the thin PET bands 72, as... Figure 38 As shown in the diagram. The suture 154 that secures the PET tape and leaflet structure 14 to the skirt 16 can be any suitable suture, such as Ethibond suture. The suture 154 is intended to follow the curvature of the bottom edge of the leaflet structure 14, as described in more detail below.

[0066] Known fabric skirts consist of a fabric of warp and weft fibers that extend perpendicularly to each other, with one set of fibers extending perpendicular to the upper and lower edges of the skirt. When the metal frame to which the fabric skirt is attached is radially compressed, the overall axial length of the frame increases. Unfortunately, the fabric skirt, inherently possessing limited elasticity, cannot stretch along with the frame and therefore often deforms the frame's supports and hinders uniform pleating.

[0067] Figure 17 Examples of pleated flaps are shown, where the support structure has been deformed in several places, as indicated by reference numeral 100, due to the skirt having fibers extending perpendicular to the upper and lower edges of the skirt. Furthermore, in some locations the fabric tends to bunch or form excessive bulges of material, which limits the minimum pleat profile and hinders uniform pleating.

[0068] refer to Figure 16B In contrast to known fabric skirts, skirt 16 is preferably woven from a first group of fibers, or yarns, or threads 78 and a second group of fibers, or yarns, or threads 80, neither of which are perpendicular to the upper edge 82 and lower edge 84 of the skirt. In a specific embodiment, the first group of fibers 78 and the second group of fibers 80 extend at an angle of approximately 45 degrees relative to the upper and lower edges 82, 84. Skirt 16 can be formed by weaving fibers at a 45-degree angle relative to the upper and lower edges of the fabric. Alternatively, the skirt can be diagonally cut from a vertically woven fabric (where fibers extend perpendicular to the edges of the material), such that the fibers extend at a 45-degree angle relative to the upper and lower cut edges of the skirt. Figure 16B The diagram further shows that the relatively short edges 86 and 88 of the skirt are not intended to be perpendicular to the upper and lower edges 82 and 84. For example, the short edges 86 and 88 are intended to extend at an angle of approximately 45 degrees relative to the upper and lower edges and are therefore aligned with the fibers 78 of the first group. Thus, the overall shape of the skirt is an elongated oblique rectangle.

[0069] Figure 19A and 19B The skirt 16 is shown after the opposing edge portions 90 and 92 have been sewn together to form the annular shape of the skirt. As shown, edge portions 90 may be arranged in an overlapping relationship relative to opposing edge portions 92, and the two edge portions may be sewn together with a seam line 94 extending diagonally parallel to edges 86 and 88. The upper edge portion of the skirt 16 may be formed by a plurality of protrusions 96 defining a wave shape that generally follows the shape of the fourth row of pillars 28 immediately adjacent to the lower end of the axial pillars 31. In this way, as... Figure 20As best shown, the upper edge of the skirt 16 can be securely fastened to the support post 28 with stitches 70. The skirt 16 may also have a slit 98 to facilitate attachment of the skirt to the frame. The slit 98 is sized such that the upper edge of the skirt partially wraps around the support post 28 and reduces stress in the skirt during attachment. For example, in the illustrated embodiment, the skirt 16 is placed inside the frame 12 with the upper edge of the skirt partially wrapping around the upper surface of the support post 28 and secured in place with stitches 70. This method of partially wrapping the upper edge of the skirt around the support post 28 provides a stronger and more durable attachment of the skirt to the frame. The skirt 16 can also be secured with stitches 70 to the supports 22, 24, and 26 in the first, second, and third rows, respectively.

[0070] Refer again Figure 16B Due to the orientation of the fibers relative to the upper and lower edges, the skirt can experience greater elongation in the axial direction (i.e., from the upper edge 82 to the lower edge 84).

[0071] Therefore, when the metal frame 12 is pleated (as shown) Figure 18 As shown in the illustration, the skirt 16 can elongate along the frame in the axial direction, thus providing a more uniform and predictable pleated profile. In the illustrated embodiment, each mesh of the metal frame includes at least four angled supports that rotate in the axial direction (i.e., the angled supports are more aligned with the length of the frame). The angled supports of each mesh act as a mechanism for rotating the fibers of the skirt in the same direction as the supports, causing the skirt to elongate along the length of the supports. This allows the skirt to be more elongated and avoids undesirable deformation of the supports when the flap is pleated.

[0072] Additionally, the spacing between the woven fibers or yarns can be increased to allow the skirt to elongate in the axial direction. For example, for a PET skirt 16 formed from 20 denier yarn, the yarn density can be about 15% to about 30% less than that of a conventional PET skirt. In some instances, the yarn spacing of skirt 16 can range from about 155 yarns per foot to about 180 yarns per foot, such as about 160 yarns per foot, while in a conventional PET skirt, the yarn spacing can range from about 217 yarns per foot to about 247 yarns per foot. The slanted edges 86, 88 promote a uniform and consistent distribution of fabric material along the inner circumference of the frame during pleating, thereby minimizing fabric bundles to promote uniform pleating to the smallest possible diameter. Furthermore, cutting diagonal seams vertically may leave loose frayed edges along the cut edges. The slanted edges 86, 88 help minimize this. As described above, Figure 17 Displays pleated flaps with a regular skirt shape, the fibers of which are perpendicular to the upper and lower edges of the skirt. (Comparison) Figure 17 and 18 It is evident that the construction of skirt 16 avoids undesirable deformation of the frame supports and provides more uniform frame pleats.

[0073] In an alternative embodiment, the skirt may be formed of woven elastic fibers that can extend axially during the folding of the valve. The warp and weft fibers may be perpendicular and parallel to the upper and lower edges of the skirt, or alternatively, they may extend at an angle between 0 and 90 degrees relative to the upper and lower edges of the skirt, as described above.

[0074] The inner skirt 16 may be sewn to the frame 12 at a location away from the seam 154, thus allowing the skirt to be softer in that area (see...). Figure 28 This avoids stress concentration at the seam 154 that attaches the lower edge of the leaflet to the skirt 16.

[0075] As described above, in the illustrated embodiment, the leaflet structure 14 includes three flexible leaflets 400 (although more or fewer leaflets may be used). Figure 21 As best shown in the diagram, each leaflet 400 in the illustrated construction has an upper (outflow) free edge 110 extending between opposing upper protrusions 112 on opposite sides of the leaflet. Each upper protrusion 112 has a notch 114 below it, separating the upper protrusion from a corresponding lower protrusion 116. The lower (inflow) edge portion 108 of the leaflet extending between the respective ends of the lower protrusions 116 includes a vertical or axial edge portion 118 on opposite sides of the leaflet, extending downward from the corresponding lower protrusion 116; and a substantially V-shaped intermediate edge portion 120 having a smooth, curved tip portion 119 and a pair of inclined portions 121 at the lower end of the leaflet, the inclined portions 121 extending between the axial edge portion and the tip portion. The inclined portions may have a larger radius of curvature than the tip portions. Each leaflet 400 may have a reinforcing band 72, which is secured (e.g., sewn) to the inner surface of the lower edge portion 108, such as... Figure 22 As shown in the image.

[0076] The leaflets 400 can be fixed to each other on their adjacent sides to form a connecting portion 122 of the leaflet structure. Multiple flexible connectors 124 (one of which is shown) Figure 23 The flexible connector 124 can be used to connect adjacent sides of paired leaflets and to mount the leaflets to the connecting window frame portion 30. The flexible connector 124 may be formed from a woven PET fabric sheet, although other synthetic and / or natural materials may be used. Each flexible connector 124 may include a wedge 126 extending from its lower edge to its upper edge at the center of the connector. The wedge 126 may include a non-metallic material, such as a rope or a sheet of Ethibond 2-0 stitching material, secured to the connector with temporary stitches 128. The wedge 126 helps prevent rotational movement of the leaflet protrusions when they are secured to the connecting window frame portion 30. The connector 124 may have a series of inner notches 130 and outer notches 132 formed along its upper and lower edges.

[0077] Figure 24 The adjacent sides of two leaflets 400 interconnected by flexible connector 124 are shown. Opposite end portions of the flexible connector 124 may be positioned in an overlapping relationship with a lower protrusion 116, with an inner notch 130 aligned with the vertical edge of the protrusion 116. Each protrusion 116 may be secured to the corresponding end portion of the flexible connector 124 by stitching along a line extending from an outer notch 132 on the lower edge to an outer notch 132 on the upper edge of the connector. Three leaflets 400 may be secured end-to-end to each other using three flexible connectors 124, as shown. Figure 25 As shown in the image.

[0078] For reference Figure 26 and 27 The adjacent sub-joint portions 118 of the two leaflets can be directly sewn together. In the shown example, PTFE-6-0 suture material is used to form in-and-out sutures 133 and comb sutures 134, which extend through the sub-joint portions 118 and reinforcing bands 72 on the two leaflets. The remaining two adjacent sub-joint portions 118 are sewn together in the same manner to form a combined leaflet structure 14, which can then be secured to the frame 12 in the following manner.

[0079] As described above, the inner skirt 16 can be used to help sew the leaf-shaped structure 14 to the frame. Figure 28 As shown, skirt 16 may have wavy temporary marker sutures 136 to guide attachment of the lower edge of each leaflet 400. Skirt 16 itself may be sewn to the supports of frame 12 using sutures 70, as described above, and then the leaflet structure 14 is secured to skirt 16. Supports intersecting the marker sutures 136 are desiccated not to skirt 16. This makes skirt 16 more flexible in areas not secured to the frame and minimizes stress concentration along the sutures securing the lower edge of the leaflet to the skirt. A portion of skirt 16 initially demarcated by rectangle 140 is not secured to frame 12 and is later secured to the frame after the leaflet structure 14 is secured to the skirt, as further described below. As described above, when skirt is secured to the frame, the fibers 78, 80 (see Figure 16B Align the supports roughly at an angle to the frame to promote even folding and expansion of the frame.

[0080] Figure 29 It is a cross-sectional view of a portion of the frame and the leaflet structure, showing the adjacent protruding portions of two leaflets fixed to the corresponding window frame portion 30. Figures 30-36 This illustrates a specific method for fixing the connecting portion 122 of the leaflet structure 14 to the connecting window frame portion 30 of the frame. First, as... Figure 30As shown, the flexible connector 124, which secures the two adjacent sides of the two leaflets, is folded laterally, and the upper protruding portion 112 is folded downward against the flexible connector. Figure 30 and 31 In the optimal configuration, each upper protruding portion 112 is folded longitudinally (vertically) to form an L-shape, such that the inner portion 142 is folded against the inner surface of the leaflet and the outer portion 144 is folded against the connector 124. The outer portion 144 can then be sewn to the connector 124 along the suture line 146. Next, as... Figure 31 As shown, the connecting protrusion kit (consisting of a pair of lower protrusion portions 116 connected by connector 124) is inserted through the connecting window 20 of the corresponding window frame portion 30. Figure 32 This is a side view of frame 12, showing the connecting protrusion kit that extends outward through the window frame portion 30.

[0081] like Figure 29 and 33 In the optimal configuration, the connecting protrusion kit is radially inwardly pressed at the wedge-shaped portion 126, such that one lower protrusion portion 116 and a portion of the connector 124 are folded against the frame 12 on one side of the window frame portion 30, and the other lower protrusion portion 116 and a portion of the connector 124 are folded against the frame 12 on the other side of the window frame portion 30. A pair of stitches 148 are formed to hold the lower protrusion portion 116 in place with... Figure 29 The same manner shown in the image rests against frame 12. Each suture 148 extends through connector 124, lower protrusion portion 116, wedge portion 126, and another portion of connector 124. Then, as... Figure 29 and 34 As shown, each lower protruding portion 116 is secured to the corresponding upper protruding portion 112 with a main suture 150, the main suture 150 extending through a connector 124, the lower protruding portion 116, another connector 124, another connector 124, and the upper protruding portion 112. Finally, as... Figure 29 and 35 As shown, the suture material used to form the main suture 150 can be used to further form a lockstitch 152 at the edges of the protruding portions 112, 116, which extends through the two-layer connector 124 sandwiched between the protruding portions 112, 116.

[0082] like Figure 29 and 30As shown, the downwardly folded upper protrusion portion 112 forms a double layer of leaflet material at the joint. The inner portion 142 of the upper protrusion portion 112 is arranged flat adjacent to the two leaflets 400 forming the joint, so that each joint includes only four layers of leaflet material within the window frame 30. This four-layer portion of the joint is more resistant to bending or pivoting than the leaflet 400 portion that is only radially inward from the relatively more rigid four-layer portion. This allows the leaflets 400 to pivot primarily at the inner edge 143 of the downwardly folded inner portion 142 in response to blood flowing through the valve during in vivo operation, rather than pivoting around the axial strut of the window frame 30. Because the leaflets are pivoted at a position radially inward from the window frame 30, the leaflets avoid contact with and damage to the frame. However, under strong forces, the four-layer portion of the joint can pivot around the longitudinal axis 145 adjacent to the window frame 30. Figure 29 The inner portion 142 unfolds, folding outward against its respective outer portion 144. This may occur, for example, when the valve 10 is compressed and mounted on the delivery shaft, allowing for a smaller fold diameter. The four-layered portion of the commissure can also unfold around the shaft 145 as the balloon catheter inflates during valve inflation, which releases some of the pressure exerted on the commissure by the balloon and thus prevents damage to the commissure during inflation.

[0083] After all three connecting protrusion kits are secured to the window frame portion 30, the lower edges of the leaflets 400 between the connecting protrusion kits can be sewn to the inner skirt portion 16. For example, as Figures 36-38 As shown, each leaflet 400 can be sewn to the skirt 16 along suture line 154 using, for example, Ethibond thread. The suture line can be a through suture that extends through each leaflet 400, the skirt 16, and each reinforcing band 72. Each leaflet 400 and its respective reinforcing band 72 can be sewn to the skirt 16 separately. In this way, the lower edge of the leaflet is secured to the frame 12 via the skirt 16. Figure 38 As shown, the leaflets can be further secured to the skirt with lockstitch 156, which extends through each reinforcing band 72, leaflet 400, and skirt 16, while forming a loop around the edges of the reinforcing band 72 and leaflet 400. The lockstitch 156 can be formed of PTFE stitching material. Figure 39 and 40 The frame 12, leaf structure 14, and skirt 16 are shown after the leaf structure and skirt are fixed to the frame and the leaf structure is fixed to the skirt.

[0084] Figure 41Shown as a plan view of the outer skirt 18 before it is attached to the frame 12. The outer skirt 18 may be formed from a strong, durable sheet of material such as woven PET laser-cut or otherwise, although other synthetic or natural materials may be used. The outer skirt 18 may have a substantially straight lower edge 160 and upper edge 162, which define a plurality of alternating protrusions 164 and notches 166. Figure 42 In optimal display, the lower edge 160 of the skirt 18 can be sutured to the lower edge of the inner skirt 16 at the inflow end of the valve. (As shown) Figure 43 As shown, each protrusion 164 can be sewn to the second crossbar II support 24 of the frame 12. The corners 162 of the protrusion 164 can be folded onto their respective supports of the crossbar II and secured with sutures 168.

[0085] As in Figure 1 , 3 As seen in section 43, the outer skirt 18 is fixed to the frame 12 such that, when the frame is in its expanded state, there is excess material or slack between the lower and upper edges 160, 162 of the outer skirt, which is not flat against the outer surface of the frame 12. In other words, the outer skirt is configured with excess material, which causes the outer skirt to bulge outward as the frame shortens (i.e., its length decreases) during radial expansion. Therefore, when the valve 10 is placed in the body, the excess material of the outer skirt 18 can fill the gap between the frame 12 and the surrounding natural ring, contributing to the formation of a good fluid seal between the valve and the natural ring. Thus, the outer skirt 18 cooperates with the inner skirt 16 to prevent perivalvular leakage after valve 10 implantation. In another advantageous feature, the slack between the lower and upper edges of the outer skirt 18 allows the frame 12 to elongate axially during folding without any resistance from the outer skirt, and the outer skirt substantially does not affect the outer diameter of the artificial valve in the folded state.

[0086] Figure 56 Display mounted on the slender shaft 180 of the conveyor device Figure 1-3 The valves 10, 42-43, form a delivery kit for implantation of the valve 10 in a patient. The valve 10 is mounted in a radially compressive configuration for delivery into the body. The shaft 180 includes an inflatable balloon 182 for inflating the balloon within the body, with the pleated valve 10 positioned above the deflated balloon. When in a radially compressive mounting configuration, the frame 12 of the valve 10 includes an inflow portion 174 (see...). Figure 54The outer diameter D2 of the valve 10 is smaller than the outer diameter D1 of the outflow portion of the frame. The tapering of the frame may be at least partly due to the V-shaped leaflet 400, since the V-shaped leaflet has less leaflet material in the inflow portion of the frame 12 compared to the more rounded U-shaped leaflet. Due to the tapered shape of the frame 12 in the installed state, and even with the thickness of the outer skirt 18 located around the inflow portion 174 of the frame 12, the total outer diameter of the inflow portion of the valve 10 may be approximately equal to or less than the total outer diameter of the outflow portion of the valve.

[0087] Moreover, such as Figure 56 As shown, valve 10 includes a commissural portion of the leaflet that extends radially outward through a corresponding window frame portion 30 to a position outside the frame and is sutured to the side struts of the commissural window frame. To minimize the pleated shape of the valve, when the valve is radially compressed axially into a contracted configuration, the window frame portion 30 may be radially recessed inward relative to the peripheral portion of the frame, such as the frame portion extending between adjacent commissural windows. For example, when the valve contracts radially, the commissural window 30 of the frame may be recessed inward by a radial distance between 0.2 mm and 1.0 mm relative to the frame portion extending between adjacent commissural windows. In this way, the outer diameter of the valve outflow portion including the commissural portion may be substantially consistent with that of the commissural portion protruding outward from the peripheral portion of the valve—which could impede valve delivery to the body. Even with the radially recessed commissural window frame 30, the outer diameter of the inflow portion of the frame can still be less than or approximately equal to the outer diameter of the outflow portion of the frame when the valve contracts radially on the axis, allowing for a minimum maximum overall valve diameter. By minimizing the valve diameter when mounted on the delivery axis, the kit can be accommodated in a smaller diameter catheter and thus can pass through smaller blood vessels in the body and can generally be minimally invasive.

[0088] Figure 44 The illustration depicts an artificial heart valve 200 according to another embodiment. The heart valve 200 includes a frame or stent 202 and leaflet structures 204 mounted on the stent. The leaflet structure 204 may include a plurality of leaflets 218 (e.g., three as described), which may be sutured to each other and to the frame 202 using suitable techniques and / or mechanisms. The frame 202 may be adapted to include a fusion frame portion 30 (e.g., ...). Figure 4 (As shown in the image) to help sew the leaflets to the frame.

[0089] Frame 202 possesses some of the design features of frame 12. Specifically, like frame 12, frame 202 has relatively large frame openings 206 along the area of ​​the supporting leaf structure of the frame, such as... Figure 45As shown in the diagram, the opening 206 is defined by a row of angled struts 208 at the outlet end of the frame, a plurality of axially extending, circumferentially spaced struts 210, and a middle row of angled struts 212. As shown, the axial struts 210 are desiccated to be thinner than the junction 214, which connects the opposite ends of the axial struts 210 to the intersection of two struts 212 and the intersection of two struts 208. Due to this configuration, when the valve is radially compressed to the delivery configuration, the width of the opening 206 remains sufficiently large to allow portions of the leaflet structure 204 to protrude outwards through the opening, as shown in the diagram. Figure 46 and 47 As indicated in 216. This allows the valve to be folded to a relatively smaller diameter compared to the assumption that all leaflet material is confined within the folded frame.

[0090] For the purpose of comparison, Figure 48 This is a cross-section of a known artificial valve 250, showing the valve in a folded state. When the valve is radially compressed, the spacing between adjacent struts is relatively small and does not allow portions of the leaflet structure to protrude outward through the frame. As a result, the presence of all leaflet material confined within the frame limits the folded diameter of the valve.

[0091] Figure 49 and 50 The planar section of the optional frame construction is shown, which allows portions of the leaflet to protrude outward through the folded frame. This frame construction can be implemented in the valve 10 described above. Figure 49 The frame cross-section shows the radial compression state, while Figure 50 A cross-section of the frame in a radially expanded state is shown. The frame (only a portion is shown) comprises a first row of angled struts 442 extending circumferentially and at least a second row of angled struts 444 extending circumferentially. Some openings in the frame are rhomboid openings 446, formed by adjacent struts 442 connected to each other at their upper ends and adjacent struts 444 connected to each other at their lower ends. The frame also includes larger openings 448, formed by adjacent struts 442 connected to the respective ends of horizontal struts 450 at their upper ends and adjacent struts 444 connected to the respective ends of horizontal struts 452 at their lower ends. When the frame is radially compressed, the horizontal struts 450, 452 maintain the width W of the openings 448 sufficiently large to allow portions of the valve leaflets to protrude outward through the frame. Therefore, when the frame is folded, the width of the openings 448 is greater than the width of the openings 446. The frame may be formed such that the openings 446, 448 alternate around the circumference of the frame. Optionally, the opening 448 may be located at a position selected along the length and circumference of the frame to correspond to areas where leaf material is likely to accumulate within the frame, such as between joints.

[0092] Figure 51 and 52This shows a planar cross-section of another frame construction that allows portions of the leaflet to protrude outward through the folded frame. This frame construction can be implemented in the aforementioned valve 10. Figure 51 The frame cross-section shows the radial compression state, while Figure 52 The frame cross-section is shown in a radially expanded state. The frame (only a portion is shown) comprises a first row of angled struts 402 extending circumferentially and at least a second row of angled struts 404 extending circumferentially. Some openings in the frame are rhomboid openings 406, formed by adjacent struts 402 connected to each other at their upper ends and adjacent struts 404 connected to each other at their lower ends. The frame also includes openings 408, formed by adjacent struts 402 connected to enlarged nodes or junctions 410 at their upper ends and adjacent struts 404 connected to enlarged nodes or junctions 412 at their lower ends. Junctions 410, 412 add rigidity to the frame at those locations, so that when the frame is radially compressed, the width W of the opening 408 remains sufficiently large to allow the leaflet portion of the valve to protrude outward through the frame. Therefore, when the frame is folded, the width of the opening 408 is greater than the width of the opening 406. The frame can be formed with openings 406 and 408 alternating around the circumference of the frame. Optionally, the openings 408 can be located at selected positions along the length and circumference of the frame to correspond to areas where leaf material tends to accumulate within the frame, such as between joints.

[0093] Figure 57 This illustrates a leaflet 500 of an artificial valve (e.g., valve 10 or 200) according to another embodiment. The leaflet 500 has an overall V-shape similar to that of the leaflet 400 described above. The leaflet 500 has two protruding portions 502 on opposite sides of the leaflet, which are attached to adjacent protruding portions of the other leaflet to form a commissure of the leaflet structure. The sub-commissure portion of the leaflet 500 (the portion below the protrusions 502) includes two generally straight edges 504 extending from their respective locations just below the protrusions 502 to a curved lower edge 506. Figure 58 This shows the approximate shape of the leaflet 500 when the valve is folded. When folded, the frame (not shown) Figures 57-58 The middle part is slightly elongated, causing leaflet 500 to become slightly elongated.

[0094] The tapering shape of the commissure portion of the leaflet reduces the amount of leaflet material compressed in the lower half of the valve, minimizing the compression diameter of this portion of the valve. Therefore, if another component is installed to this portion of the valve, such as the outer skirt 18, the reduced shape of this portion helps to offset or minimize the diameter increase caused by that additional component. Furthermore, the commissure protrusion 502 is relatively short and requires fewer sutures than known leaflet designs (such as T-shaped and serrated leaflets) to form the commissure of the leaflet structure, which distributes better and reduces the volume of leaflet material when the valve is compressed.

[0095] Figure 59 This shows a cross-sectional view of a valve 500 according to another embodiment. The valve 500 includes a frame 502, leaflets 504, and an outer skirt 18 mounted (e.g., by stitching) to the outer surface of the frame 502. The frame 502 has a thickness that varies along its length to optimize strength in selected areas of the frame when needed, while minimizing material usage (and thus minimizing the pleated profile). In the shown embodiment, the maximum thickness of the outflow portion 506 of the frame is T1 (measured from the inner diameter to the outer diameter of this portion of the frame), and the minimum thickness of the inflow portion 508 of the frame is T2 (measured from the inner diameter to the outer diameter of this portion of the frame). It should be noted that the struts of the frame 502 forming the outflow portion 506 (not shown) Figure 59 The thickness of the middle section is T1, and the thickness of the support forming the inflow end portion 508 is T2. Frame 502 may have the same construction as frame 12 described above, except for the variable thickness of the frame. The area with reduced thickness can be formed using various manufacturing techniques, such as electropolishing selected portions of the frame (to mask non-polished portions), grinding selected portions of the frame, wire cutting, or other suitable techniques.

[0096] The outflow portion 502 roughly corresponds to the suture zone supporting the leaflet 504 and is typically subjected to the maximum load on the valve. Therefore, the outflow portion 502 of the frame has a larger thickness T1 to selectively provide the required strength under the expected load. The inflow portion 508 supports an additional layer of material due to the outer skirt 18. The reduced thickness of the inflow portion 508 allows the inflow portion to be pleated to a smaller diameter than the outflow portion. This offsets or minimizes the increase in pleat diameter caused by the addition of the outer skirt 18.

[0097] Figures 60-62 Another embodiment of the transplantable artificial valve 310 is shown, which includes a leaflet structure 314 and a radially contractile and expandable frame 312 (with...). Figure 11Similar to the frame 50 shown, it has a plurality of radially spaced connecting windows 318 for securing the leaflet structure within the frame. The valve 310 also includes a skirt 316 secured between the inner surface 312 of the frame of the leaflet structure 314 and the curved lower edge 364. The valve 310 has a lower inflow end 340 and an upper outflow end 342.

[0098] like Figure 60A As shown, each window 318 includes a closed opening 334 between two axially extending side pillars 320. Each side pillar includes a generally rectangular, for example, square, cross-sectional profile, such as... Figure 63 As shown in the figure, each rectangular side support 320 includes four surfaces: an outer surface 324 facing outwards radially, an inner surface 326 facing inwards radially, a middle surface 328 on the side facing the other side support, and a transverse surface 330 on the side away from the other side support. In other embodiments, the side supports may include other cross-sectional shapes, such as circular or hexagonal.

[0099] The leaflet structure includes multiple leaflets 360, each including a pair of side protrusions 366 fixed to a frame 312, a curved lower edge 364 fixed to a skirt portion 316, and a pivot portion 372 between the side protrusions and the lower edge. Each side protrusion 366 mates with an adjacent side protrusion of another leaflet 360 to form a connecting portion 376 of the leaflet structure 314. Each pair of side protrusions 366 extends radially outward through a corresponding connecting portion window 318 to a position 312 outside the frame, and is fixed, for example, to a side pillar 320 of the window with sutures. Figure 62 As shown in the figure. In some embodiments, each side protrusion 366 includes a terminal portion 368 (see Figure 1). Figure 64 The two side protrusions 368 of each joint 376 are far apart from each other and extend circumferentially along the outer surface 324 of the respective side pillars 320 of the window 318.

[0100] In some embodiments, each joint 376 further includes at least one non-rigid reinforcing sheet 378 stitched to the side protrusion 366 and to the side support 320. The sheet 378 may comprise a flexible, tear-resistant material, including a variety of natural and / or synthetic biocompatible materials. Exemplary synthetic materials may include polymers such as nylon, siloxanes, and polyesters, including PET. In one embodiment, the sheet 378 comprises a woven PET fabric.

[0101] Each reinforcing piece 378 may be generally rectangular (when laid flat) and may include a middle portion 380 and opposing end portions 386. In some embodiments, the first end portion 386 of the piece is secured to a first side post 320 and the second end portion 386 of the piece is secured to a second side post 320, such as... Figure 64 As shown in the diagram, sheet 378 separates the side protrusion 366 from the side support 320, so that the side protrusion does not contact the side support. For example, each end portion 386 of the sheet can completely enclose its respective side support 320, as shown in the diagram. Figure 64 As shown in the image.

[0102] The side protrusion 366 and the reinforcing plate 378 can be secured to the side strut 320 in multiple stages. For example, Figure 63 An exemplary first suturing stage is shown, wherein a sheet is placed such that the middle portion 380 of the sheet extends circumferentially across the outer surface of the end portion 368 of the side protrusion 366, and each end portion 386 of the sheet extends between the respective outer, middle, and inner surfaces 324, 328, 326 of the respective side protrusion 366 and the respective side strut 320. A sheet 378 surrounds the side protrusion 366 and protects the side protrusion from the edges of the side strut 320. A pair of through sutures 390 secure one end of each side protrusion 366 and sheet 378 to the respective strut 320. Figure 63 As shown, each suture 390 is oriented approximately perpendicular to the circumference of the frame 312 along the side surface 330 of the side support 320 and can radially pass back and forth through the joint 376 at multiple different longitudinal positions. Each suture 390 can intersect with the first layer sheet 378, the side protrusion end portion 368, the second layer sheet, and the third layer sheet, moving radially inward in this order. The suture 390 secures the sheet 378 to the side protrusion end portion 368 and fastens the sheet end portion 386 around the side support 320, thereby securing the side protrusion 366 to the side support 320 and the leaflet structure 314 to the frame 312.

[0103] Figure 64 This illustrates an exemplary second stitching stage, wherein a second pair of sutures 392 is used to secure the slack portion of the reinforcing piece 378. For example, the second sutures 392 may intersect with a portion extending laterally beyond the middle portion 380 of the first suture 390 and the end portion 386 of the piece. The second sutures 392 may be spiral overlock sutures that intersect the joining portion 376 at multiple different longitudinal locations, such as... Figure 62 As shown in the figure, the loose portion of the piece 378 is firmly fixed against the side surface 330 of the side support.

[0104] The first suture 390 and the second suture 392 may be arranged adjacent to the side surface 330 of the support 320 and spaced apart from the window opening 334. This arrangement of the sutures reduces the stress on the suture caused by the movement of the pivot portion 372 of the leaflet. Instead, much of this stress is transferred from the elastic hinge 370 of the leaflet to the interior of the support—the side support 320 near the middle edge 332.

[0105] When the leaflet pivots between its open and closed positions, the reinforcing plate 378 prevents the resilient hinge 370 from being damaged by the inner-middle edge 332 of the support 320, such as... Figure 64 As shown in the diagram. Additionally, some embodiments may also include a longitudinally extending padding strip 374 located between the resilient hinge 370 and the support 320, such as adjacent to the inner-middle edge 332. Figure 64 As shown, this is to further prevent damage to the resilient hinge caused by the support. The padding band 374 may include a flexible, compressible material, such as PET fabric, pericardial tissue, or various other biocompatible materials. In some embodiments, the padding band may include a tube filled with an elastic material. For example, the padding band may include a PET tube filled with pericardial tissue. In other embodiments, the outer tubular cover of the padding band may be formed of a sheet 378 and may be filled with an elastic material. The sheet may be secured around the elastic material with sutures to maintain proper positioning of the padding band, such as... Figure 64 As shown in the figure. In other embodiments, a separate padding strip 374 may be sewn to the reinforcing sheet 378. The padding strip 374 may have a thickness similar to that of the window frame grid 62 to provide a radial gap between the side strut 320 and the pivot portion 372 of the leaflet to prevent or minimize contact between the inner surface of the leaflet and the frame during the cardiac cycle.

[0106] Figure 65 Display similar to Figure 63 and 64 The implementation methods are different, but with different suturing patterns. Figure 65 In this arrangement, suture 390 is replaced by suture 398, which secures piece 378 around the end portion 368 of the side protrusion. Each suture 398 intersects the middle portion 380 of the piece, a side protrusion 366, and a second layer of piece adjacent to the middle-outer edge 324 of each side support. Suture 398 may include through sutures that intersect the joint at multiple different longitudinal locations. Each end portion of piece 378 may include a folded portion 388 folded underneath to form a double layer of piece 378 along the surface of the respective side support 320. Suture 392 secures the end portion 386 of the piece and the end portion 368 of the side protrusion tightly around the side surface 330 of the side support.

[0107] Figure 66 and 67 This shows an alternative method for suturing the side protrusions 366 and 378 to the side struts 320. Figure 66Showing sutures 394 arranged along the outer surface 324 of the side struts and generally perpendicular to the radius of the frame. Sutures 394 intersect the two side protrusions 366 and the two end portions 386 of the piece 378. Sutures 394 tightly secure each end portion 386 of the piece around the intermediate surface, inner surface, and side surfaces 328, 326, 330 of its respective side strut 320, and also loosely secure the intermediate portion 380 of the piece around the end portions 368 of the side protrusions 366. Figure 66 In the illustrated embodiment, the suture 394 intersects the first sheet A, the second sheet B, the two side protrusions 366, the third sheet C, and the fourth sheet D in this order.

[0108] After the first suture 394 is in place, the end portion 368 of the side protrusion is extended and arranged adjacent to the outer surface 324 of the side strut 320, as follows. Figure 67 As shown in the diagram. This tightens the loose middle portion 380 of the sheet surrounding the end portion 368 of the side protrusion. A pair of sutures 396 then securely fasten the middle portion 380 of the sheet to the end portion 386 of the sheet to hold the end portion 368 of the side protrusion in place, as shown in the diagram. Figure 67 As shown in the diagram. Suture 396 can be a circular overlock suture that intersects the joining portion 376 at several different longitudinal positions, and... Figure 64 The suture 392 is similar.

[0109] Figure 68 and 69 This illustrates another alternative method for suturing the side protrusions 366 and 378 to the side struts 320. Figure 68 The suture 395 is shown, arranged along the outer side of the window opening and oriented approximately perpendicular to the radius of the frame. The suture 395 intersects with two portions of the two side protrusions 366 and the piece 378. The suture 395 secures the middle portion 380 of the piece, which extends loosely around the end portions 368 of the side protrusions 366. Figure 68 In the embodiment shown, the suture 395 intersects the first sheet A, the first side protrusion B, the second side protrusion C, and the second sheet D in this order.

[0110] After the first suture 395 is in place, the end portion 368 of the side protrusion is extended and arranged adjacent to the outer surface 324 of the side strut 320, as follows. Figure 69 As shown in the diagram. This tightens the loose middle portion 380 of the sheet surrounding the end portion 368 of the side protrusion. A pair of sutures 397 then secure the middle portion 380 of the sheet tightly to the end portion 386 of the sheet to hold the end portion 368 of the side protrusion in place, as shown in the diagram. Figure 69As shown in the diagram, the end portion 386 of the sheet may include a folded-down portion 388 to form a double-layered sheet material to reinforce the suture 397. The suture 397 may be a circular overlock suture that intersects the connecting portion 376 at multiple different longitudinal locations, and... Figure 62 The suture 392 is similar.

[0111] Figure 70 and 71 This shows another alternative method for suturing the side protrusions 366 and 378 to the side struts 320. Figure 70 The suture 395 is shown, arranged along the outer side of the window opening and oriented generally perpendicular to the radius of the frame. The suture 395 intersects with the two side protrusions 366 and four portions or layers of the sheet 378. Each end portion 386 of the sheet includes a folded portion 388 forming a double layer of sheet material between the side protrusions 366 and the intermediate surface 328 of the side struts. The suture 395 secures the intermediate portion 380 of the sheet loosely around the end portions 368 of the side protrusions 366. Figure 70 As shown, each suture of suture 395 intersects with a first pair of sheet layers including layers A and B, a first side protrusion C, a second side protrusion D, and a second pair of sheet layers including layers E and F in this order.

[0112] After the first suture 395 is in place, the end portion 368 of the side protrusion is extended and arranged adjacent to the outer surface 324 of the side strut 320, as follows. Figure 71 As shown in the diagram. This causes the middle portion 380 of the piece surrounding the end portion 368 of the side protrusion to tighten. A pair of sutures 397 then secure the middle portion 380 of the piece to the end portion 386 of the piece to hold the end portion 368 of the side protrusion in place, as shown in the diagram. Figure 71 As shown in the diagram, the folded portion 388 of the sheet forms a double-layered sheet material to reinforce the suture 397. The suture 397 may be a circular overlock suture, which intersects the connecting portion 376 at several different longitudinal positions, and... Figure 62 The suture 392 is similar.

[0113] Used to attach leaflet structure 314 to Figures 61-71 The various structures of the connecting parts of the window frame 318 shown in the image can also be used to... Figure 1-3 Optionally, the leaflet structure 14 of the valve 10 is attached to the window frame portion 30 of the frame 12.

[0114] Figures 72-74This illustration shows an artificial heart valve kit 600, including an embodiment of a frame 602 for the artificial valve, mounted on a balloon 606 of a delivery shaft 604. The frame 602 may be similar in shape to frame 12 and may include an inlet portion 610, an outlet portion 612, and an intermediate portion 614. For clarity, other valve components, such as leaflets and skirts, are not shown. The frame 602 may have a reduced thickness at the inlet and outlet portions 610 and 612 relative to the thickness of the intermediate portion 614. Due to the thinner end portions, when the balloon 606 is inflated, the end portions 610 and 612 provide less resistance to inflation and inflate faster than the intermediate portion 614, such as... Figure 73 As shown in the diagram. Because the distal portion inflates faster than the middle portion, the frame 602 is restrained on the airbag 606, preventing the frame from sliding towards either end of the airbag and reducing the risk of the frame prematurely slipping out of the airbag. Figure 74 As shown, further inflation of the balloon causes the middle portion 614 of the frame to expand to the same final diameter as the distal portions 610, 612 for implantation, after which the balloon can be deflated and removed. Controlling the position of the valve on the balloon during delivery may be important, especially for frames that shorten and move relative to the balloon during inflation. Figures 72-74 In the embodiment shown, the middle portion 614 of the frame can remain constant relative to the airbag, while the two end portions shorten towards the middle portion due to the "dumbbell" effect of the airbag. Any conventional method can be used to produce the frame 602 with reduced thickness at the end portions 610, 612, such as sanding the end portions or similar methods. In one embodiment, the thickness of the end portions 610, 614 of the frame is approximately 0.37 mm, while the thickness of the middle portion 614 is approximately 0.45 mm.

[0115] Given the many possible implementations applying the disclosed inventive principles, it should be recognized that the illustrated embodiments are merely preferred embodiments of the invention and should not be considered as limiting the invention. Rather, the scope of the invention is defined by the appended claims. Therefore, we claim protection for all our inventions within the scope of these claims.

Claims

1. Artificial heart valves, which include: A radially contractible and expandable annular frame, the frame comprising a plurality of angledly spaced connecting windows, each connecting window comprising a closed opening between first and second axially oriented side pillars; The leaflet structure is located within the frame and includes a plurality of leaflets, each leaflet including two opposing side protrusions, each side protrusion pairing with an adjacent side protrusion of a neighboring leaflet to form a ferrule of the leaflet structure, each pair of side protrusions extending radially outward through a corresponding ferrule window to a position outside the frame, wherein portions of the protrusions located outside the frame extend circumferentially away from each other and along the outer surface of the side support. and Multiple wedge-shaped portions, each wedge-shaped portion located between the side pillars of the connecting portion window and separating the pair of side protrusions extending through the connecting portion window, the wedge-shaped portions being forced radially inward between the side protrusions; Multiple connector pieces, each connector piece being sewn to a corresponding pair of side protrusions, wherein each of the wedge-shaped portions is sewn to a corresponding connector piece among the connector pieces.

2. The valve according to claim 1, wherein each wedge portion is elongated in the axial direction and the axial length corresponds to the axial length of the side strut of the connecting portion window.

3. The valve of claim 2, wherein the wedge-shaped portion restricts the movement of the lateral protrusion relative to the commissural window.

4. The valve of claim 1, wherein the wedge portion is sutured to the pair of lateral protrusions.

5. The valve of claim 1, wherein the wedge portion comprises suture material.

6. The valve according to claim 1, wherein the wedge portion is non-metallic.

7. The valve according to claim 1, wherein the wedge portion comprises a sheet of fabric material.

8. The valve of claim 1, wherein the connector piece extends along the radially outer surface of the wedge portion and the separated side protrusions extending through the connecting window.

9. Artificial heart valves, including: A radially contractible and expandable annular frame, the frame comprising a plurality of angledly spaced connecting windows, each connecting window comprising a closed opening between first and second axially oriented side pillars; The leaflet structure is located within the frame and includes a plurality of leaflets, each leaflet including two opposing side protrusions, each side protrusion pairing with an adjacent side protrusion of a neighboring leaflet to form a ferrule of the leaflet structure, each pair of side protrusions extending radially outward through a corresponding ferrule window to a position outside the frame, wherein portions of the protrusions located outside the frame extend circumferentially away from each other and along the outer surface of the side support. and Multiple wedges, each comprising a flexible, non-metallic material, are located between side pillars of the connecting window and separate a pair of side protrusions extending through the connecting window, the wedges being forced radially inward between the side protrusions.

10. The valve of claim 9, wherein the wedge portion comprises suture material.

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