Artificial heart valve and processing method thereof

Abstract

The invention discloses an artificial heart valve and a processing method. The heart valve prosthesis comprises a support and a plurality of valve leaflets connected to the support, the support is of a cylindrical structure, a blood flow channel is formed in the support, each valve leaflet comprises a body, the body has the transverse direction and the longitudinal direction which are opposite in the flattened state, and the outer edge of the body comprises a free edge and a fixed edge which are distributed on the two opposite sides in the longitudinal direction; the valve leaflets are fixed to the support through the fixing edges of the valve leaflets, and the free edges of the valve leaflets are matched with one another to control a blood flow channel in the artificial heart valve. The lug pieces are arranged on the two transverse opposite sides of the body, the free edges and the fixed edges of the lug pieces intersect at the corresponding sides, and each lug piece is provided with a first bending part which is bent towards the transverse inner side of the body from the combination part of the lug piece and the body and is attached to the body to form a combination part of a double-layer structure; and the second bending part is bent from the tail end of the first bending part to the transverse outer side of the body. By improving the valve leaflet structure and the suture method, the sealing effect and safety of the valve leaflet are improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an artificial heart valve and a processing method thereof. Background Art

[0002] The existing artificial heart valve includes a stent and a leaflet arranged on the stent. The stent is cylindrical and has a blood flow channel inside. The leaflet includes a free edge, a fixed edge and an ear piece where the two intersect. The free edge controls the blood flow channel in the artificial heart valve through deformation, and the fixed edge is used to fix to the stent.

[0003] Artificial heart valves can be applied to the aorta, mitral valve, tricuspid valve, etc. The corresponding leaflets can be adaptively selected as two or three according to different application scenarios. Taking three leaflets as an example, they can be connected to the stent by sutures, bonding or one-piece molding.

[0004] refer to Figures 1 to 3 The top side of the leaflet 100 in the artificial heart valve 200 is a free edge 120, and the bottom side is a fixed edge 130. The intersection of the free edge 120 and the fixed edge 130 is an ear piece 140. During processing, the ear pieces 140 of the two adjacent leaflets are first sutured with sutures, and then the whole is connected to the stent 210. However, the tightened sutures during suturing will cause a certain deformation of the free edge, which may cause poor closure in the vicinity of the stent, affecting the sealing effect of the blood flow channel. Summary of the Invention

[0005] The present application provides a leaflet of an artificial heart valve, an artificial heart valve, and a processing method, which solve the problem of poor leaflet closure in the prior art.

[0006] The present application provides a leaflet of an artificial heart valve, comprising:

[0007] The body has opposite transverse and longitudinal directions in a flattened state, and the outer edge of the body includes a free edge and a fixed edge distributed on two opposite sides of the longitudinal direction;

[0008] The ear pieces are arranged on two opposite sides of the body in the transverse direction, and the free edge and the fixed edge intersect at the ear pieces on the corresponding sides. The part where the ear piece is combined with the free edge is provided with an outward protrusion extending longitudinally relative to the free edge, and the outward protrusion intersects with the trend extension line of the fixed edge.

[0009] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0010] Optionally, at least 1 / 4 of the area of ​​the outer protrusion is located inside the extension line of the fixed edge.

[0011] Optionally, the outer protrusion is strip-shaped, and the length direction of the strip is consistent with the transverse direction of the body.

[0012] Optionally, along the transverse direction of the body, the outer protrusion has an inner edge and an outer edge relative to each other, and the outer edge transitions to the top side of the ear piece.

[0013] Optionally, the outer edge is substantially parallel to the outer side of the ear piece.

[0014] Optionally, along the transverse direction of the body, the outer side of the ear piece exceeds the outer edge by at least 2 mm.

[0015] Optionally, along the transverse direction of the body, the outer side of the ear piece exceeds the outer edge by 2.5 to 5 mm.

[0016] Optionally, the portion where the ear piece is combined with the fixed edge has an opening area.

[0017] Optionally, the lateral positions of the outer protrusion and the opening area are aligned.

[0018] Optionally, the lateral length of the convex portion is 1 to 3 mm, and the longitudinal length is 0.2 mm to 0.8 mm. For example, the lateral length of the convex portion is 1.08 mm to 2.43 mm, and the longitudinal length is 0.29 mm to 0.44 mm.

[0019] One embodiment of the present application further discloses an artificial heart valve, comprising a stent and a plurality of leaflets connected to the stent, wherein the stent is a cylindrical structure with a blood flow channel inside, and the leaflets include:

[0020] The body has opposite transverse and longitudinal directions in a flattened state, the outer edge of the body including free edges and fixed edges distributed on two opposite longitudinal sides, the multiple leaflets being fixed to the support via respective fixed edges, and the free edges of the multiple leaflets cooperating with each other to control the blood flow channel within the artificial heart valve;

[0021] The ear pieces are arranged on two opposite sides of the body in the transverse direction, wherein the free edge and the fixed edge meet at the ear pieces on the corresponding sides, and the ear pieces have:

[0022] A first bent portion, which is bent from the joint between the ear piece and the body toward the transverse inner side of the body and abuts against the body to form a double-layer structure;

[0023] a second bending portion, bent from an end of the first bending portion toward a transverse outer side of the body;

[0024] The joints between two adjacent leaflets are sutured and fixed to each other, and are fixed to the radial inner side of the stent. The second bent portion of each leaflet extends to the radial outer side of the stent and wraps around the corresponding part of the stent, and is sutured and fixed to the stent at the wrapped part.

[0025] Optionally, a portion where the ear piece is combined with the free edge is provided with an outward protrusion extending longitudinally relative to the free edge, and in the combined portion, the outward protrusion is folded in half.

[0026] Optionally, the junction between two adjacent leaflets is fixed by a first suture, wherein the first suture is one or more, and all the knots in the first suture are located on the top side of the outer protrusion. Preferably, the first suture is one.

[0027] Preferably, the first suture has two knots, which are arranged side by side on the top sides of the outer protrusions of two adjacent leaflets.

[0028] Optionally, the joint portion is arranged with a plurality of thread holes along the longitudinal direction of the body, and the first suture is passed through each thread hole. For at least one of the thread holes, the suture extends through the thread hole toward the lateral outside of the body and wraps around the joint portion.

[0029] Optionally, for all the thread holes in the connecting portion, the first suture extends through the thread holes toward the lateral outside of the main body and wraps around the connecting portion.

[0030] Optionally, the coupling portion is connected to the bracket via a second suture.

[0031] Optionally, at least a portion of the stent is a support bar, and the second suture is wrapped around the support bar and has multiple loops along the extension direction of the support bar.

[0032] Optionally, along the circumference of the stent, all knots in the second suture are located lateral to the support strip.

[0033] Optionally, along the circumference of the stent, at least one side of the support strip has a recessed area, and the knot in the second suture is located in the recessed area.

[0034] Optionally, each loop of the second suture has a knot.

[0035] Optionally, each of the second sutures passes through the junction of two adjacent leaflets on the radial inner side of the stent.

[0036] Optionally, the second bending portions of two adjacent leaflets wrap around the support bar from two opposite sides of the support bar.

[0037] Optionally, the second bent portion wraps around the knot of the second suture.

[0038] Optionally, the second bent portion is connected to the support bar via a third suture, and along the circumference of the stent, all knots in the third suture are located laterally to the support bar, preferably on the same side.

[0039] Optionally, along the circumference of the stent, the support strip has two opposite sides, one side is a first recessed area for inserting the knot of the second suture; the other side is a second recessed area for inserting the knot of the third suture.

[0040] Optionally, all knots in the second suture and the third suture are placed in corresponding recessed areas.

[0041] Optionally, there are multiple recessed areas on the same side of the support bar arranged along the extension direction of the support bar, and the second suture and the third suture are respectively wrapped around the support bar multiple times, and each wraparound has a knot, and each knot is located in a recessed area at a corresponding position.

[0042] Optionally, each of the third sutures passes through the junction of two adjacent leaflets and the second bending portion on the radial inner side of the stent.

[0043] Optionally, in the same leaflet, the second bending portion and the joining portion are abutted against each other to form a three-layer structure, and the third suture runs through the three-layer structure.

[0044] Optionally, the second suture and the third suture are each one or more.

[0045] Optionally, the first suture, the second suture and the third suture pass through the joining portion through the same or different suture holes.

[0046] Optionally, two or three of the first suture, the second suture and the third suture are the same suture.

[0047] An embodiment of the present application further discloses an artificial heart valve, comprising a stent and a plurality of leaflets connected to the stent, wherein the stent is a cylindrical structure and has a blood flow channel inside;

[0048] At least a portion of the stent is a support bar, and along the circumference of the stent, at least one side of the support bar has a recessed area, and the leaflet is fixed to the support bar by sutures, and all knots in the sutures are located in the corresponding recessed areas.

[0049] Optionally, the leaflet includes:

[0050] The body has opposite transverse and longitudinal directions in a flattened state, the outer edge of the body including free edges and fixed edges distributed on two opposite longitudinal sides, the multiple leaflets being fixed to the support via respective fixed edges, and the free edges of the multiple leaflets cooperating with each other to control the blood flow channel within the artificial heart valve;

[0051] Ears are arranged on two opposite sides of the body in a transverse direction, and the free edge and the fixed edge meet at the ear pieces on the corresponding sides;

[0052] The ears between two adjacent leaflets are connected to each other through a first suture, and are also connected to the support bar through a second suture and a third suture, wherein all the knots in the second suture and the third suture are located in corresponding recessed areas.

[0053] Optionally, the portion where the ears between two adjacent leaflets are connected to each other through the first suture rests against the radial inner side of the support strip.

[0054] Optionally, the ears between two adjacent lobes cooperate with each other to wrap the support bar.

[0055] Optionally, the knot in the second suture is wrapped by the ear piece, and the knot in the third suture is exposed to the ear piece.

[0056] Optionally, the two axial sides of the bracket are opposite inflow sides and outflow sides, wherein a circle of hexagonal cells is arranged circumferentially on the outflow side, and the support bar serves as a common side between two adjacent cells.

[0057] Optionally, the extension direction of the support bar is the axial direction of the bracket.

[0058] An embodiment of the present application further discloses a method for manufacturing an artificial heart valve, comprising:

[0059] The joint portion between the ear piece and the body is bent toward the transverse inner side of the body, and abutted against the body to form a double-layer structure joint portion, wherein the outer convex portion is folded in half;

[0060] The junctions of the two adjacent leaflets are in a state of being in contact with each other and aligned, and the convex portions of the two leaflets are sewed together using a first suture, and after suturing, a knot is tied at the top side of the convex portions to secure;

[0061] Sutures are inserted multiple times into the junction of two adjacent leaflets for suturing and reinforcement;

[0062] Using a second suture, suturing the junction of two adjacent leaflets to the radial inner side of the stent;

[0063] The ears of two adjacent leaflets are bent toward the transverse outside of the body and extended to the radial outside of the stent to wrap the corresponding part of the stent, and the wrapped part is sutured and fixed to the stent using a third suture.

[0064] This application further improves the sealing effect and safety of the leaflets by improving the leaflet structure and suturing method. BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Figure 1 This is a structural schematic diagram of the leaflet in the expanded state in the prior art;

[0066] Figure 2 for Figure 1 Schematic diagram of the structure after multiple leaflets are sutured;

[0067] Figure 3 Schematic diagram of the structure of an artificial heart valve in the prior art;

[0068] Figure 4 A schematic structural diagram of an artificial heart valve leaflet in a flattened state according to an embodiment of the present application;

[0069] Figure 5 for Figure 4 Schematic diagram of the structure of the middle and outer convex parts and the opening area;

[0070] Figure 6a A schematic structural diagram of an artificial heart valve according to an embodiment of the present application;

[0071] Figure 6b It is a schematic structural diagram of an ear piece having a first bending portion and a second bending portion;

[0072] Figure 7 A schematic diagram of the structure of suturing the joint using the first suture;

[0073] Figure 8 It is a schematic diagram of the structure when the junction of the two leaflets is unfolded;

[0074] Figure 9 for Figure 7 The middle part is a schematic diagram of the structure in which the two joints are unfolded;

[0075] Figure 10 It is a structural schematic diagram of the first suture being sutured from top to bottom when the two joints are unfolded;

[0076] Figure 11 for Figure 10 Schematic diagram of the structure in which the first suture is sutured from bottom to top;

[0077] Figure 12a This is a schematic structural diagram of a bracket according to an embodiment of the present application;

[0078] Figure 12b for Figure 12a A magnified view of middle A;

[0079] Figure 12c A schematic diagram of a structure for suturing the two joints and the support strip using a plurality of second sutures;

[0080] Figure 13 A schematic diagram of the structure of using multiple third sutures to wrap the ear piece of the valve leaflet around the support bar and sew it;

[0081] Figure 14a A schematic diagram of a structure in which a single second suture is used to sew the two joints and the support bar;

[0082] Figure 14b Schematic diagram of the structure of using a single third suture to wrap the ear piece of the valve leaflet around the support bar and sew it;

[0083] Figure 15a A schematic structural diagram of an artificial heart valve according to an embodiment of the present application;

[0084] Figure 15b This is a schematic diagram of the structure of the support strips of one embodiment of the present application being sewn together with the leaflets of the existing structure;

[0085] Figure 16 A flowchart of a method for manufacturing an artificial heart valve according to an embodiment of the present application;

[0086] Figures 17 to 24 Schematic diagram of the process of suturing the two leaflets to the stent;

[0087] Figure 25 This is a schematic structural diagram of an artificial heart valve according to an embodiment of the present application.

[0088] The reference numerals in the figures are described as follows:

[0089] 100, leaflet; 110, body; 120, free edge; 130, fixed edge; 131, opening area; 140, ear piece; 150, outer protrusion; 151, inner edge; 152, outer edge; 170, junction; 171, first bend; 172, second bend; 173, thread hole; 173a, thread hole; 173b, thread hole; 173c, thread hole; 173d , thread hole; 173e, thread hole; 173f, thread hole; 174, first suture; 175, thread hole; 175a, thread hole; 175b, thread hole; 175c, thread hole; 176, second suture; 177, thread hole; 177a, thread hole; 177b, thread hole; 177c, thread hole; 178, third suture; 180, thread knot; 181, thread knot; 182, thread knot;

[0090] 200, artificial heart valve; 210, stent; 220, support bar; 221, recessed area; 222, first recessed area; 222a, first recessed area; 222b, first recessed area; 222c, first recessed area; 223, second recessed area; 223a, second recessed area; 223b, second recessed area; 223c, second recessed area;

[0091] 300. Anti-circular leakage assembly; 310. Base; 320. Anti-circular leakage component. DETAILED DESCRIPTION

[0092] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0093] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be an intermediate component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be an intermediate component.

[0094] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this application pertains. The terms used herein in the specification of this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0095] In this application, the terms "first," "second," etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number or order of the technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, "plurality" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0096] In this application, the terms "comprises" and "comprising" and any variations thereof are intended to cover non-exclusive inclusions, for example, a system, product or apparatus comprising a list of elements is not necessarily limited to those elements expressly listed but may include other elements not expressly listed or inherent to such products or apparatuses.

[0097] refer to Figures 4 and 5An embodiment of the present application provides a leaflet 100 of an artificial heart valve, comprising: a body 110 having opposite transverse and longitudinal directions in a flattened state; an outer edge of the body 110 including a free edge 120 and a fixed edge 130 distributed on two opposite longitudinal sides; wherein the free edge 120 controls a blood flow channel in the artificial heart valve by deformation;

[0098] The ear pieces 140 are arranged on two opposite sides of the body 110 in the transverse direction. The free edge 120 and the fixed edge 130 intersect at the ear pieces 140 on the corresponding side. The part where the ear piece 140 and the free edge 120 are combined is provided with an outer protrusion 150 extending longitudinally relative to the free edge 120.

[0099] The horizontal and vertical directions involved in this application can be referred to Figure 4 Specifically, the X direction is the horizontal direction, and the Y direction is the vertical direction. Leaflet 100 is generally symmetrical. The following description and some of the accompanying figures use one side as an example, with the other side being similarly described. The leaflet material can be conventionally selected, such as a biomaterial or synthetic material, with the desired strength and biocompatibility.

[0100] During suturing, the tabs 140 of the two leaflets 100 are folded and attached to form a suture, and finally tightened and tied to secure the suture. The knot is specifically arranged on the convex portion 150. When the suture is tightened and knotted, the convex portion 150 deforms and absorbs stress, greatly reducing the impact on the free edge 120. In other words, the tightening and knotting of the suture does not significantly interfere with the free edge 120, thus resolving the problem of poor blood flow channel closure caused by deformation of the free edge 120 during suturing of the leaflet 100. The convex portion 150 also increases the area of ​​the connection suture site, providing additional strength.

[0101] In this embodiment, the outer protrusion 150 intersects the extension line of the fixed edge 130. The inner side of the extension line is basically the working area of ​​the leaflet 100. The outer protrusion 150 is located at this position to take into account both the connection strength and the opening size of the leaflet 100. For example, at least 1 / 4 of the area of ​​the outer protrusion 150 is located on the extension line of the fixed edge 130 (refer to Figure 4 For another example, at least 1 / 2, or even 3 / 4 of the area of ​​the outer protrusion 150 is located inside the extension line of the fixing edge 130.

[0102] The outer protrusion 150 itself is strip-shaped, approximately rectangular, and the length direction of the strip is consistent with the transverse direction of the body. After folding into a double-layer structure, it can still maintain the necessary transverse span to facilitate suturing operations and absorb deformation caused by compression of the knot.

[0103] The outer convex portion 150 has an inner edge 151 and an outer edge 152 relative to each other. The outer edge 152 transitions to the top side of the ear piece 140 , i.e., there is a distinct corner, which also makes the outer edge 152 roughly parallel to the outer side of the ear piece 140 .

[0104] When folded in half, the outer protrusion 150 provides sufficient structural strength around the thread holes 173a described below. To reduce the need for folding and sewing the ear piece 140, the outer edge of the ear piece 140 extends at least 2 mm beyond the outer edge 152 in the transverse direction of the body, for example, 2.5 to 5 mm beyond the outer edge. The area where the ear piece 140 meets the fixed edge 130 has an opening 131. Because the ear piece 140 must be folded during sewing, the opening 131 reduces traction and deformation of the body 110 and ear piece 140 during folding, particularly relieving tensile stress during longitudinal deflection.

[0105] Furthermore, the convex portion 150 and the opening area 131 are aligned laterally. In the unfolded state, the convex portion 150 is roughly rectangular, with its lateral length greater than that of the opening area 131, and the opening area 131 is located below the centerline of the rectangle (L1 in the figure represents the centerline). When folded, the convex portion 150 forms a double-layer structure, further enhancing strength.

[0106] In this embodiment, the lateral length of the outer protrusion 150 is 1-3 mm, and the longitudinal length is 0.2 mm-0.8 mm. For another example, the lateral length of the outer protrusion 150 is 1.08 mm-2.43 mm, and the longitudinal length is 0.29 mm-0.44 mm.

[0107] refer to Figure 6a-6b One embodiment of the present application further discloses an artificial heart valve 200, comprising a stent 210 and a plurality of leaflets 100 connected to the stent 210. The stent 210 is a cylindrical structure with an internal blood flow channel and a hollowed-out lattice structure on the sidewalls. Unless otherwise specified, the shape or size of the lattice structure is not strictly limited. Surgical or transcatheter intervention can be used for implantation. During transcatheter intervention, the stent 210 is processed using a material corresponding to the release mode, such as a nickel-titanium alloy with shape memory that can self-expand in vivo, or a stainless steel material that can be released by balloon expansion. The stent 210 itself can be formed by cutting a tube or braiding a wire.

[0108] In this embodiment, improvements are made to the folding and suturing of the leaflet 100, wherein the leaflet 100 includes:

[0109] The body 110 has opposite transverse and longitudinal directions when flattened. The outer edge of the body 110 includes free edges 120 and fixed edges 130 distributed on two opposite longitudinal sides. The multiple leaflets 100 are fixed to the support 210 via their respective fixed edges 130. The free edges 120 of the multiple leaflets 100 cooperate with each other to control the blood flow channel within the artificial heart valve.

[0110] The ear pieces 140 are arranged on two opposite sides of the body 110 in the transverse direction. The free edge 120 and the fixed edge 130 meet at the ear pieces 140 on the corresponding sides. The ear pieces 140 have:

[0111] The first bent portion 171 is bent from the joint between the ear piece 140 and the body 110 toward the transverse inner side of the body 110 and abuts against the body 110 to form a double-layer structure joint portion 170;

[0112] The second bending portion 172 is bent from the end of the first bending portion 171 toward the lateral outside of the body 110;

[0113] The inner side and the outer side are relative to the body 110, with the side closer to the midline of the body 110 being the inner side, and the side farther from the midline of the body 110 being the outer side. To facilitate suturing with the stent 210, the joints 170 between two adjacent leaflets 100 are abutted against each other and fixed by suturing (during processing, the leaflets 100 can be pre-fixed to each other to form a cylindrical preform), and are abutted against and fixed to the radial inner side of the stent 210 (the joints 170 and the stent 210 can also be fixed by suturing). The second bend 172 of each leaflet 100 extends to the radial outer side of the stent 210 and wraps around the corresponding portion of the stent 210, and is sutured and fixed to the stent 210 at the wrapped portion.

[0114] The artificial heart valve 200 of this embodiment can utilize the leaflets 100 of the above-mentioned embodiments, that is, the portion where the ear piece 140 and the free edge 120 are combined is provided with an outer protrusion 150 extending longitudinally relative to the free edge 120. In the joint 170, the outer protrusion 150 is folded in half (roughly along its own midline) to increase strength.

[0115] refer to Figures 7 and 8 The junction 170 between two adjacent leaflets 100 is fixed by a first suture 174. The first suture 174 may be one or more sutures. All knots 180 in the first suture 174 are located on the top side of the convex portion 150, so that the convex portion 150 can absorb the stress and deformation at the knotted portion after deformation. Specifically, the first suture 174 is first passed through the two junctions 170. As can be seen in the figure, the needle insertion portion is located at the intersection of the convex portion 150 and the extension line of the free edge 120. The first knot is then tied to pre-fix the two junctions 170 for subsequent suturing and fixation.

[0116] In order to better secure the joint 170 between two adjacent leaflets 100, a plurality of thread holes 173 are arranged along the longitudinal direction of the body 110 on the joint 170, and the first suture 174 is passed through each thread hole 173. In the multi-layer structure, the thread holes that are aligned on each layer are considered to be the same thread hole when calculating the number. There are three thread holes 173 in the longitudinal direction, namely thread hole 173a, thread hole 173b, and thread hole 173c. Thread hole 173a is located near the outer protrusion 150. After the joints 170 of two adjacent leaflets 100 are stacked, the first suture 174 passes through all the thread holes 173 on each side in the thickness direction from the knotted position downward. Of course, the order of threading can be various. To avoid redundancy, the first suture 174 passes only once between any two thread holes 173, and there is no repetition in the path.

[0117] After the first suture 174 passes through all the thread holes 173, it returns to the top side of the outer protrusion 150 and is then tied a second time, completing the fixation of the two joints 170. As can be seen in the figure, the first suture 174 as a whole has two knots 180, which are arranged side by side on the top sides of two adjacent outer protrusions 150. At this time, the knots 180 only interfere with the outer protrusions 150, that is, the outer protrusions 150 will undergo a certain deformation, while the deformation of the outer protrusions 150 has a relatively weak interference effect on the free edge 120, thereby reducing the impact on the free edge 120.

[0118] refer to Figure 9 In order to better reinforce the two joints 170 in the transverse direction, for at least one thread hole, the first suture 174 extends through the thread hole (specifically, thread hole 173a and / or thread hole 173b) toward the transverse outside of the body 110 and wraps around the joint 170. In this embodiment, for thread hole 173a and thread hole 173b, the first suture 174 extends toward the transverse outside of the body 110 and wraps around the joint 170 at both thread holes.

[0119] The specific threading and winding method of the first suture 174 can adopt existing technology, such as reference Figures 10 and 11 , is a schematic diagram of the first suture 174 being threaded through the thread holes 173, wherein the solid line specifically represents the thread on the outside (which can be seen), and the dotted line specifically represents the thread threaded between two corresponding thread holes 173 (which is hidden between the thread holes and cannot be seen). For ease of understanding, the thread holes of the other leaflet 100 are shown on the right, which are respectively represented as thread hole 173d, thread hole 173e, and thread hole 173f. When the first suture 174 is threaded, thread hole 173d is aligned with thread hole 173a, thread hole 173e is aligned with thread hole 173b, and thread hole 173f is aligned with thread hole 173c.

[0120] Taking the downward suture as an example, after the two joints 170 are pre-fixed by threading and knotting, the first suture 174 can be passed through the thread hole 173a, and then passed from the inside of the thread hole 173a to the other corresponding thread hole 173d, and then passed through the thread hole 173d to the thread hole 173e, and then passed through the thread hole 173e to the thread hole 173b, and then passed through the thread hole 173b to the thread hole 173c, and then passed through the thread hole 173c to the thread hole 173f. Suturing is then performed upwards, with the first suture 174 passing through hole 173f to hole 173e. The suture is then wound circumferentially around holes 173e and 173b, then passed through hole 173b until it enters hole 173a. Similarly, the suture is wound circumferentially around holes 173a and 173d, then passed through hole 173d and secured with another knot at the other end. This completes the threading of the first suture 174. Of course, other threading methods can also be used, and this is not specifically required in this embodiment. Preferably, the same path is not repeated.

[0121] refer to Figures 12a to 13 After the first suture 174 is threaded and wound, the joint 170 is connected to the inner side of the bracket 210 through the second suture 176. The bracket 210 generally has a hollow grid structure. The fixed edge 130 can be fixed by sewing according to the existing technology. The present application also improves the connection method between the ear piece 140 and the bracket 210.

[0122] At least a portion of the bracket 210 in the embodiment of the present application is a support bar 220, which can serve as a part of the grid frame (of course, the support bar 220 can also be located on the top side of the bracket 210, and the specific position can be set according to needs). In order to adapt to the fixation of the ear piece 140, the overall extension direction of the support bar 220 is the axial direction of the bracket 210, but the support bar 220 is not strictly limited to a straight bar.

[0123] The second suture 176 is passed through the joint 170 and is also passed around the outside of the support bar 220, with multiple passes along the extension direction of the support bar 220. The corresponding thread holes 175 for passing the second suture 176 are arranged in the longitudinal direction.

[0124] The thread hole 175 of the second suture 176 is closer to the support bar 220 than the thread hole 173 for passing the first suture 174, and can also be staggered longitudinally with the thread hole 173 to avoid strength loss caused by adjacent thread holes being too close.

[0125] In this embodiment, the wire holes 175 are arranged along the axial direction, specifically three in number, and the three wire holes are all located on the joint portion 170, namely wire hole 175a, wire hole 175b, and wire hole 175c. Of course, the number of wire holes 175 is not specifically limited and can be set according to needs.

[0126] Furthermore, along the circumference of the stent 210, all knots 181 in the second suture 176 are located lateral to the support bar 220, thereby avoiding increasing the radial dimension after compression and reducing friction on external tissues or components. Preferably, all knots 181 in the second suture 176 are located on the same side of the support bar 220.

[0127] In order to facilitate the fixation of the knot 181, at least one side of the support bar 220 is provided with a recessed area 221 along the circumference of the bracket 210. The knot 181 in the second suture 176 is located in the recessed area 221. The recessed area 221 can be a structural bend of the support bar 220 itself, a cutout portion, or a branch structure such as a grid. The recessed area 221 facilitates the fixation of the knot 181 and reduces the protruding portion. The knot 181 is not easily axially slid and falls off in the recessed area 221.

[0128] To strengthen the connection between the joint 170 and the support bar 220, each loop of the second suture 176 includes a knot 181. Each loop of the second suture 176 passes through the joint 170 of two adjacent leaflets 100 on the radially inner side of the stent 210, ensuring a tighter fit between the two joints 170. Each knot 181 is placed within a corresponding recessed area 221.

[0129] The second bends 172 of two adjacent leaflets 100 wrap around the support bar 220 from opposite sides to enhance connection strength. The second bends 172 also enclose the knots 181 of the second sutures 176, simplifying the overall design and reducing the number of exposed knots. The second bends 172 are connected to the support bar 220 via third sutures 178. Along the circumference of the stent 210, all knots 182 in the third sutures 178 are located lateral to the support bar 220. To facilitate knotting and positioning, all knots 182 in the third sutures 178 are preferably located on the same side of the support bar 220. Specifically, for the same support bar 220, on two opposing sides along the circumference of the stent 210, one side has a first recessed area 222 for insertion of all knots 181 of the second sutures 176, while the other side has a second recessed area 223 for insertion of all knots 182 of the third sutures 178.

[0130] All the knots 180 in the second suture 176 and the third suture 178 are placed in the corresponding recessed areas. The first recessed area 222 and the second recessed area 223 can be arranged symmetrically or staggered relative to the support bar 220.

[0131] There are multiple recessed areas on the same side of the support bar 220 arranged along the extension direction of the support bar 220. The second suture 176 and the third suture 178 are respectively wrapped around the support bar 220 multiple times, and each wrap has a knot, and each knot is located in a corresponding recessed area.

[0132] Each third suture 178 passes through the junction 170 and the second bend 172 of two adjacent leaflets 100 on the radially inner side of the stent 210. That is, within the same leaflet 100, the second bend 172 and the junction 170 abut against each other to form a three-layer structure, and the third suture 178 passes through this three-layer structure. Of course, when the third suture 178 passes through the junction 170, in order to minimize the number of suture holes, the third suture 178 can be passed through the suture holes 175 of the second suture 176.

[0133] The second suture 176 and the third suture 178 are each one or more. In this embodiment, one is preferred. Figure 14a-14b , respectively, are a schematic diagram of suturing when the second suture 176 is a single suture and a schematic diagram of suturing when the third suture 178 is a single suture, in which case the sutures between the two adjacent sutures extend continuously. Of course, there is no single specific way to tie a knot, and a variety of existing ways can be used to tie a knot.

[0134] The first suture 174, the second suture 176 and the third suture 178 pass through the joint 170 through the same or different suture holes. For example, the suture hole 173 of the first suture 174 and the suture hole 175 of the second suture 176 may partially or completely overlap and share the same hole.

[0135] Two or three of the first suture 174, the second suture 176, and the third suture 178 may be the same suture. That is, after each stage of suturing, the suture is not cut, but directly proceeds to the next stage of suturing. Each of the second suture 176 and the third suture 178 is not strictly limited to a single loop and may be wrapped around the support strip 220 one or more times.

[0136] The support bar 220 with the recessed area 221 can accommodate the knot to prevent the knot from being outside the stent 210. Of course, it can also be combined with the leaflet of the existing structure, such as referring to Figure 15a-15b An embodiment of the present application further discloses an artificial heart valve 200, which includes a stent 210 and a plurality of leaflets 100 connected to the stent 210. The stent 210 is a cylindrical structure with a blood flow channel inside.

[0137] The stent 210 may be a balloon-expandable stent or a self-expanding stent, and the material of the stent 210 may be cobalt-chromium alloy or nitinol.

[0138] The bracket 210 is a tubular structure, which is generally straight or slightly flared at the inflow end. The bracket 210 has hollow cells, and the two ends of the bracket 210 are the inflow side and the outflow side respectively. The bracket can have multiple rows of cells from the inflow end to the outflow end, and the shape of the cells can be quadrilateral or hexagonal. For example Figure 25As shown, the outflow end may be a row of hexagonal cells, and the rest may be quadrilateral cells.

[0139] In the cells of the outflow end of the stent 210, each hexagonal cell includes axially vertical struts, at least a portion of which is a support bar 220 for fixing the leaflet (see Figure 12a ), for example, includes 3 support bars, and these 3 support bars are evenly distributed in the circumferential direction.

[0140] Along the circumference of the bracket, at least one side of the support bar 220 has a recessed area 221 (see Figure 12b ), the leaflet 100 is fixed to the support bar 220 by sutures, and all the knots in the sutures are located in the corresponding recessed areas 221, making the overall structure more concise and reducing interference with other components.

[0141] The leaflet 100 includes:

[0142] The body 110 has opposite transverse and longitudinal directions when flattened. The outer edge of the body includes a free edge 120 and a fixed edge 130 distributed on two opposite longitudinal sides. The multiple leaflets 100 are fixed to the support 210 via their respective fixed edges 130. The free edges of the multiple leaflets 100 cooperate with each other to control the blood flow channel within the artificial heart valve.

[0143] The ears 140 are arranged on two opposite sides of the body in the transverse direction, and the free edge 120 and the fixed edge 130 meet at the ears 140 on the corresponding side;

[0144] The ear pieces 140 between two adjacent leaflets 100 are connected to each other through a first suture 174, and are also connected to the support bar 220 through a second suture 176 and a third suture 178, wherein all the knots 182 in the second suture 176 and the third suture 178 are located in corresponding recessed areas 221.

[0145] The structure and suturing method of the leaflets can also be combined with the previous embodiments. For example, the tabs 140 between two adjacent leaflets 100 are connected by the first suture 174 at a location that abuts against the radially inner side of the support bar 220. The tabs 140 between the two adjacent leaflets 100 cooperate with each other to wrap around the support bar 220. The knot 181 in the second suture 176 is wrapped around the tab 140, and the knot 182 in the third suture 178 is exposed to the tab 140.

[0146] The two axial sides of the bracket 210 are the inflow and outflow sides. A circle of hexagonal cells is arranged circumferentially on the outflow side, with the support bar 220 serving as the common edge between two adjacent cells. To accommodate the securement of the tab 140, the support bar 220 extends in the axial direction of the bracket 210.

[0147] In this embodiment, the artificial heart valve 200 may further include an inner skirt, which may be connected to the leaflet 100 .

[0148] Furthermore, in order to solve the problem of peripheral leakage, the artificial heart valve 200 may further include an anti-peripheral leakage component, which may be connected to the inflow side of the stent.

[0149] In one embodiment, the anti-leakage component can be an outer skirt that can be fixed to the outside of the stent. The material of the outer skirt can be biological tissue, such as pericardium, or a macromolecular material, a polymer material, such as PET.

[0150] In another embodiment, reference may be made to Figure 25 The anti-leakage assembly 300 is an integrated structure, comprising a base 310 located inside the stent and an anti-leakage component 320 fixed to the outside of the base. The anti-leakage component 320 can be a plurality of spaced-apart blocks positioned to correspond to the hollowed-out areas of the stent cells. When the stent 210 is in its expanded state after release, the anti-leakage component 320 extends radially outward from the corresponding cell along the stent, or radially protrudes above the stent periphery, achieving the desired anti-leakage effect.

[0151] Based on the structural characteristics of the artificial heart valve examples in the above embodiments, refer to Figure 16 One embodiment of the present application further discloses a method for processing an artificial heart valve, which specifically includes:

[0152] Step S100: Bend the joint portion between the ear piece 140 and the body 110 toward the transverse inner side of the body 110 so as to abut against the body 110 to form a double-layer joint portion 170. In the joint portion 170, the outer protrusion 150 is folded in half.

[0153] refer to Figures 17 and 18 In step S100, the axis (L2 in the figure) of the opening area 131 is the bending line, and the ear piece 140 is bent clockwise toward the main body 110 (Z direction) until the outer protrusion 150 itself is folded in half at the position of the bending line to form a joint portion 170. Then, the joint portions 170 of the two leaflets 100 that need to be sutured to each other are placed against each other so that the two joint portions 170 are aligned with each other.

[0154] Step S200: With the joints 170 of two adjacent leaflets 100 aligned with each other, the outer protrusions 150 of the two leaflets 100 are sutured using a first suture 174, and a knot is tied at the top side of the outer protrusion 150 to secure the joint.

[0155] refer to Figure 19Specifically, after the two connecting parts 170 are aligned, the first suture 174 is passed through the thread holes 173a of the two outer protrusions 150 in sequence. At this time, the first suture 174 passes through 4 layers in total, and then the two ends of the first suture 174 are knotted on the top side of the outer protrusion 150 to pre-fix the two connecting parts 170.

[0156] Step S300: The first suture 174 is threaded through the junction 170 of two adjacent leaflets 100 multiple times for suture reinforcement;

[0157] refer to Figure 20 Suture reinforcement specifically includes transverse reinforcement and longitudinal reinforcement. Transverse reinforcement is to pass the suture through the thread holes of the two adjacent joints 170 and wrap it circumferentially along the outer circumference of the joint 170. Longitudinal reinforcement is to thread the suture between two adjacent thread holes. After the two joints 170 are pre-fixed, the first suture 174 is respectively sutured through the thread holes 173a and 173b for transverse and longitudinal sutures (the first suture 174 is only reinforced longitudinally at the thread hole 173c). The specific step of threading the suture can adopt the improved method mentioned above or other existing technologies. Finally, the two ends of the first suture 174 are knotted again on the top side of the outer protrusion 150 to fix it. The two knots 180 are respectively located on the top side of the two outer protrusions 150.

[0158] Step S400: Using the second suture 176, suturing the joint 170 of two adjacent leaflets 100 to the radial inner side of the stent;

[0159] refer to Figure 21 After securing the two outer protrusions 150 with the first suture 174, the second suture 176 is then passed through the thread holes 175a, 175b, and 175c of the two connecting portions 170. If there are multiple second sutures 176, the second suture 176 is passed through one of the thread holes (thread hole 175a, thread hole 175b, or thread hole 175c) of the two connecting portions 170, i.e., through four layers, and then wrapped around the first recessed area 222 of the support bar 220 for knotting, with the knot hidden in the first recessed area 222. When the second suture 176 is a single one, in order to avoid repeated winding, the second suture 176 is generally sewn from the top side to the bottom side (or from the bottom side to the top side), first passing through the thread hole 175a of the two joints 170, and wrapped around the support bar 220 and tied in the first recessed area 222a, then passed through the thread hole 175b of the two joints 170, and then wrapped around the support bar 220 and tied in the first recessed area 222b. Similarly, after passing through the thread hole 175c of the two outer protrusions 150, finally wrapped around the support bar 220 and tied in the first recessed area 222c, the winding of the second suture 176 is completed.

[0160] refer to Figure 22In step S500, the ear pieces 140 of the two adjacent leaflets 100 are bent toward the lateral outside of the main body 110 (such as the X1 and X2 directions in the figure) and extended to the radial outside of the stent to wrap the corresponding part of the stent, and the wrapped part is sutured and fixed to the stent using the third suture 178.

[0161] refer to Figures 23 and 24 Specifically, when there are multiple third sutures 178, the multiple third sutures 178 are respectively passed through the thread holes of the ear piece 140 and the joint 170 and then tied and fixed in the second recessed area 223 of the bracket. When there is only one third suture 178, taking the sewing from the top side to the bottom side of the ear piece 140 as an example, the third suture 178 passes through the thread hole 177a of the ear piece 140, then passes through the thread hole 175a of the joint 170, and then passes through the thread hole 177a of the other ear piece (a single third suture 178 passes through six layers) and is knotted and fixed, and the thread knot 182 is set in the second recessed area 223a, and then the third suture 178 continues to pass through the thread hole 177a of the ear piece 140. 7b, then pass through the thread hole 175b of the connecting part 170, and then pass through the thread hole 175b of the other ear piece to be knotted and fixed in the second recessed area 223b. Similarly, the third suture 178 continues to pass through the thread hole 177c of the connecting part 170, and then passes through the thread hole 175c of the outer protrusion 150, and then pass through the thread hole 177c of the other ear piece to be knotted and fixed in the second recessed area 223c, thus completing the suturing of the stent and the two adjacent leaflets 100.

[0162] This application makes corresponding improvements to the leaflets and suturing methods to ensure the sealing effect of blood flow control and the connection strength between the leaflets and the stent. It also solves delivery problems such as the bulging of the knot, reducing safety hazards.

[0163] The technical features of the above-described embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as no contradiction exists between these combinations of technical features, they should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be deemed that the drawing also discloses examples of combinations of the various embodiments involved.

[0164] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person skilled in the art may make various modifications and improvements without departing from the spirit of the present application, and such modifications and improvements are all within the scope of protection of the present application.

Claims

1. An artificial heart valve, characterized in that It includes a stent and a plurality of leaflets connected to the stent, wherein the stent is a cylindrical structure with a blood flow channel inside, and the leaflets include: The body has opposite transverse and longitudinal directions in a flattened state, the outer edge of the body including free edges and fixed edges distributed on two opposite longitudinal sides, the multiple leaflets being fixed to the support via respective fixed edges, and the free edges of the multiple leaflets cooperating with each other to control the blood flow channel within the artificial heart valve; The ear pieces are arranged on two opposite sides of the body in the transverse direction, and the free edge and the fixed edge meet at the ear pieces on the corresponding sides, and the ear pieces have: A first bent portion, which is bent from the joint between the ear piece and the body toward the transverse inner side of the body and abuts against the body to form a double-layer structure; a second bending portion, bent from an end of the first bending portion toward a transverse outer side of the body; The joints between two adjacent leaflets are sutured and fixed to each other, and are fixed to the radial inner side of the stent. The second bent portion of each leaflet extends to the radial outer side of the stent and wraps around the corresponding part of the stent, and is sutured and fixed to the stent at the wrapped part.

2. The artificial heart valve according to claim 1, wherein The portion where the ear piece is combined with the free edge is provided with an outward convex portion extending longitudinally relative to the free edge, and in the combined portion, the outward convex portion is folded in half.

3. The artificial heart valve according to claim 2, characterized in that The joint between two adjacent leaflets is fixed by a first suture, wherein the first suture is one or more, and all the knots in the first suture are located on the top side of the outer protrusion.

4. The artificial heart valve according to claim 3, characterized in that The connecting portion is provided with a plurality of thread holes along the longitudinal direction of the body, and the first suture is passed through each thread hole. For at least one of the thread holes, the suture extends outward in the transverse direction of the body through the thread hole and wraps around the connecting portion.

5. The artificial heart valve according to claim 2, characterized in that The connecting portion is connected to the bracket through a second suture.

6. The artificial heart valve according to claim 5, characterized in that At least a portion of the stent is a support bar, and the second suture surrounds the support bar and surrounds the support bar multiple times along the extension direction of the support bar.

7. The artificial heart valve according to claim 6, characterized in that The second suture has a knot each time it is looped around the stent. Along the circumference of the stent, all the knots in the second suture are located on the side of the support strip.

8. The artificial heart valve according to claim 7, characterized in that Along the circumference of the stent, at least one side of the support strip has a recessed area, and the knot in the second suture is located in the recessed area.

9. The artificial heart valve according to claim 6, characterized in that The second bending portions of the two adjacent leaflets wrap around the support bar from two opposite sides of the support bar, and the second bending portions are connected to the support bar through a third suture. Along the circumference of the stent, the knot in the third suture is located on the side of the support bar.

10. The artificial heart valve according to claim 9, characterized in that Along the circumference of the stent, the support strip has two opposite sides, one side of which is a first recessed area for inserting the knot of the second suture; and the other side is a second recessed area for inserting the knot of the third suture.

11. An artificial heart valve, characterized in that It includes a stent and a plurality of leaflets connected to the stent, wherein the stent is a cylindrical structure with a blood flow channel inside; At least a portion of the stent is a support bar, and along the circumference of the stent, at least one side of the support bar has a recessed area, and the leaflet is fixed to the support bar by sutures, and all knots in the sutures are located in the corresponding recessed areas.

12. The artificial heart valve according to claim 11, characterized in that The two axial sides of the bracket are opposite inflow sides and outflow sides, wherein a circle of hexagonal cells is arranged circumferentially on the outflow side, and the support bar serves as a common side between two adjacent cells.

13. A method for processing an artificial heart valve, characterized in that: include: The joint portion between the ear piece and the body is bent toward the transverse inner side of the body, and abutted against the body to form a double-layer structure joint portion, wherein the outer convex portion is folded in half; The junctions of the two adjacent leaflets are in a state of being in contact with each other and aligned, and the convex portions of the two leaflets are sewed together using a first suture, and after suturing, a knot is tied at the top side of the convex portions to secure; Sutures are inserted multiple times into the junction of two adjacent leaflets for suturing and reinforcement; Using a second suture, suturing the junction of two adjacent leaflets to the radial inner side of the stent; The ears of two adjacent leaflets are bent toward the transverse outside of the body and extended to the radial outside of the stent to wrap the corresponding part of the stent, and the wrapped part is sutured and fixed to the stent using a third suture.

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