Heart valve implants

Abstract

The present invention relates to the technical field of medical devices, and discloses a heart valve graft, which includes a valve stent and an artificial valve leaflet located inside the valve stent, and the valve stent includes: a stent body; a first limiter, which is arranged at the proximal end of the stent body and is arranged to limit the movement of the valve stent toward the distal end when the valve stent is in a working state; a second limiter, which is arranged at the distal end of the stent body and is arranged to limit the movement of the valve stent toward the proximal end when the valve stent is in a working state. The heart valve graft of the present invention is delivered through a peripheral arterial vascular access route such as the femoral artery to complete the operation, and has the function of treating aortic valve stenosis and regurgitation, and has anchoring limits on both sides of the proximal end and the distal end. When used for pure regurgitation cases, the valve clip has stronger anchoring properties, and can also fix the autologous valve to reduce the risk of coronary artery opening obstruction.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a heart valve graft which can be used to treat both pure regurgitation and valvular calcification insufficiency. Background Art

[0002] The prevalence of aortic valve disease in the middle-aged and elderly population is as high as 3%. Common aortic valve diseases include aortic valve regurgitation and aortic valve stenosis. The prognosis of such diseases is extremely poor after onset, with a two-year survival rate of less than 50% and a five-year survival rate of only 20%. At present, valve replacement surgery under open-chest surgery is an effective treatment method, but patients cannot withstand traditional open-chest surgery due to their advanced age, multiple comorbidities, and poor left heart function. Transcatheter aortic valve replacement (TAVR) does not require open-chest surgery. The artificial aortic valve is implanted into the human body via a catheter to achieve the purpose of minimally invasive valve replacement. Compared with traditional surgical operations, this technology has the advantages of being more minimally invasive, faster postoperative recovery, and higher patient tolerance. It provides an equally effective and safer treatment method for patients who are contraindicated or at high risk for surgical operations.

[0003] Although TAVR has gradually matured, there are still technical problems for some special cases, such as:

[0004] (1) Currently, TAVR valve products that are accessed through the femoral artery rely solely on calcified leaflets to achieve product support. However, for patients without calcified leaflets, there are difficulties in positioning and anchoring, leading to the risk of valve displacement. For such patients, no TAVR valves that are accessed through the femoral artery have been marketed in China or abroad.

[0005] (2) Some patients with calcified valve leaflets have elongated and thickened native diseased valves. There is a risk of the native diseased valve blocking the coronary artery opening during TAVR. If the calcified valve leaflets are simply squeezed, once the coronary artery opening is blocked, it will cause acute myocardial infarction and be life-threatening. Many patients are unable to successfully undergo TAVR for this reason.

[0006] (3) Currently, the main indication for artificial heart prostheses with valve clips is simple regurgitation of artificial heart valves. However, for patients with valvular leaflet calcification, the calcified human valve leaflets may cause the arc base of the valve clip to not be in the same plane, resulting in tilt of the valve implant, which can lead to severe paravalvular leakage and treatment failure.

[0007] (4) Current products all have the possibility of paravalvular leak after surgery.

[0008] Therefore, there is a need to provide an ideal TAVR valve system that can be suitable for performing TAVR surgery via transarterial access with minimal surgical trauma and can simultaneously treat aortic valve regurgitation and stenosis. Summary of the invention

[0009] In order to solve the above problems, an embodiment of the present invention provides a heart valve graft, which includes a valve stent and an artificial valve leaflet located inside the valve stent, and the valve stent includes: a stent body; a first limiter, which is arranged at the proximal end of the stent body and is configured to limit the movement of the valve stent toward the distal end when the valve stent is in a working state; and a second limiter, which is arranged at the distal end of the stent body and is configured to limit the movement of the valve stent toward the proximal end when the valve stent is in a working state.

[0010] In some embodiments of the present invention, the stent body includes at least one first connection portion, the second limiting member includes a valve clamp, the valve clamp includes at least one second connection portion and at least one clamping portion, the first connection portion and the second connection portion are configured to be detachably connected, and the clamping portion is configured to limit the human valve leaflet between the stent body and the valve clamp when the valve stent is in a working state.

[0011] In some embodiments of the present invention, the bracket body includes a connecting piece, and the first connecting part and the second connecting part are detachably connected through the connecting piece.

[0012] In some embodiments of the present invention, the first connecting part and the second connecting part are both elastic opening deformation parts with protrusions, the connecting part is a sleeve, the sleeve has a through accommodating cavity and the distal end of the sleeve extends to form a bendable limiting portion, the accommodating cavity is configured to allow the protrusions of the first connecting part and the second connecting part to pass through after deformation, the protrusions are configured to limit the movement of the connecting part, and the limiting portion is configured to limit the deformation of the elastic openings of the first connecting part and the second connecting part after bending.

[0013] In some other embodiments of the present invention, the first connecting portion is provided with a first hole, the second connecting portion is provided with a second hole, and the connecting member is a suture or a metal buckle that can pass through the first hole and the second hole.

[0014] In some embodiments of the present invention, a clamping reinforcement piece is provided in the center of the clamping portion of the valve clamp, and the clamping reinforcement piece has a connecting end and a free end, the connecting end of the clamping reinforcement piece is fixedly connected to the clamping portion, and the free end of the clamping reinforcement piece extends from the clamping portion to the distal end of the stent, and the clamping reinforcement piece is configured to clamp the human valve leaflet to the outside of the stent body when the valve stent is in a working state.

[0015] In some embodiments of the present invention, the bottom of the clamping portion of the valve clip includes a recessed portion, and the recessed portion is configured to clamp the human valve leaflet to the outside of the stent body when the valve stent is in a working state.

[0016] In some embodiments of the present invention, the second stopper includes at least one stopper rod, the stopper rod having a connection end and a free end, the connection end being fixedly connected to the stent body, and the free end extending outward from the stent body so that the stopper rod axially presses against the human valve leaflet when the valve stent is in the working state. For example, the free end of the stopper rod is provided with a barb, and the barb is configured to clamp the human valve leaflet when the valve stent is in the working state.

[0017] In some embodiments of the present invention, the first limiting member includes a plurality of support members, which are arranged along the circumference of the stent body and fixedly connected to the stent body. The support members are arranged to expand outward from the stent body when the valve stent is in a working state to limit the movement of the valve stent toward the distal end, and encryption rods fixedly connected to the stent body are arranged between adjacent support members.

[0018] In some embodiments of the present invention, the distal end of the stent body is provided with an interface for clamping by a delivery system.

[0019] In some embodiments of the present invention, a through hole is provided at the bottom of the clamping portion of the valve clip, and the through hole is filled with a developing material.

[0020] Since the second stopper includes a detachable valve clip and a stopper rod, it is possible to choose whether to use the valve clip according to actual needs in actual use to target different diseases. For example, when used to treat pure regurgitation, all valve clips can be retained; when used to treat regurgitation caused by leaflet calcification, it is possible to choose whether to retain the valve clip according to actual conditions. For example, when encountering a patient with severe calcification, the valve clip will affect the positioning of the valve stent, and it is chosen not to retain the valve clip, and only rely on the stopper rod and the first stopper to prevent the valve graft from moving.

[0021] The aortic valve graft of the present invention can be delivered via a peripheral arterial vascular access such as the femoral artery to complete the surgery. It has the function of treating aortic valve stenosis and regurgitation, and has anchoring limits on both the proximal and distal ends. When used in pure regurgitation cases, the valve clip has stronger anchoring properties and is easier to position when released. It can also fix the autologous valve and reduce the risk of coronary artery opening obstruction.

[0022] Various aspects, features, advantages, etc. of the embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings. According to the following detailed description in conjunction with the accompanying drawings, the above aspects, features, advantages, etc. of the present invention will become more clear. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 4 is a schematic three-dimensional diagram of a heart valve implant according to Embodiment 1 of the present invention.

[0024] Figure 2 It is shown Figure 1 A schematic cross-sectional view of a heart valve graft shown positioned in a blood vessel.

[0025] Figure 3A It is shown Figure 1 A schematic diagram of the sleeve of the heart valve graft, the valve clip connection portion and the corresponding connection portions of the stent body is shown.

[0026] Figure 3B yes Figure 3A Schematic diagram of the connection method of the middle sleeve, the valve clip connection part and the corresponding connection parts of the stent body.

[0027] Figure 4 4 is a cross-sectional schematic diagram of a heart valve graft according to Embodiment 2 of the present invention located in a blood vessel.

[0028] Figure 5 It is shown Figure 4 Schematic representation of a valve clip of a heart valve graft is shown.

[0029] Fig. 6A and Figure 6B yes Figure 4 Schematic diagrams of two connection methods of the valve clip and the valve stent of a heart valve graft are shown.

[0030] Figure 7 4 is a cross-sectional schematic diagram of a heart valve graft according to Example 3 of the present invention located in a blood vessel.

[0031] Figure 8 It is shown Figure 7 A schematic top view of a valve clip of a heart valve graft is shown.

[0032] Fig. 9 4 is a perspective schematic diagram of a heart valve implant according to Embodiment 4 of the present invention.

[0033] Fig.10 It is shown Fig. 9 Schematic representation of a valve clip of a heart valve graft is shown.

[0034] Fig.11 yes Fig. 9 A schematic cross-sectional view of a heart valve graft is shown positioned within a blood vessel.

[0035] Fig.12 is a schematic diagram of another embodiment of a valve clip.

[0036] Fig.13 4 is a schematic three-dimensional diagram of a valve clip of a heart valve transplant according to Example 5 of the present invention. DETAILED DESCRIPTION

[0037] In order to facilitate understanding of various aspects, features and advantages of the technical solution of the present invention, the present invention is described in detail below in conjunction with the accompanying drawings. It should be understood that the following various embodiments are only used for illustration and are not used to limit the scope of protection of the present invention. Various different combinations of the various embodiments of the present invention can also be made without departing from the essence of the present invention.

[0038] An embodiment of the present invention provides a heart valve graft, which includes a valve stent and an artificial valve leaflet located inside the valve stent, and the valve stent includes: a stent body; a first limiter, which is arranged at the proximal end of the stent body and is configured to limit the movement of the valve stent toward the distal end when the valve stent is in a working state; and a second limiter, which is arranged at the distal end of the stent body and is configured to limit the movement of the valve stent toward the proximal end when the valve stent is in a working state.

[0039] In the embodiments of the present invention, the valve clip and the stopper have various designs, and various different embodiments are given below.

[0040] [Example 1]

[0041] Combine the following Figures 1 to 3B The heart valve implant according to the first embodiment of the present invention will be described in detail. Figure 1 is a perspective schematic diagram of a heart valve implant according to Example 1 of the present invention; Figure 2 It is shown Figure 1 A cross-sectional schematic diagram of a heart valve graft shown positioned in a blood vessel; Figure 3A It is shown Figure 1 A schematic diagram of a sleeve of a heart valve graft, a valve clip connection portion, and corresponding connection portions of a stent body; Figure 3B It is a three-dimensional schematic diagram of the connection method of the sleeve, the valve clip connection part and the corresponding connection parts of the stent body.

[0042] like Figure 1 and Figure 2As shown, the heart valve graft 1 includes a valve stent 11 and an artificial valve leaflet 12 located inside the valve stent 11. The valve stent 11 can be an outer coating, and for the sake of convenience, the coating is not shown in the figure. Among them, the valve stent 11 includes a stent body 111, a first limiter and a second limiter. The stent body 111 has an internal channel in the expanded state, and the artificial valve leaflet 12 is connected in the internal channel. The first limiter is arranged at the proximal end of the stent body 111, and is arranged to limit the movement of the valve stent toward the distal end when the valve stent is in the working state. The first limiter can also play a sealing role. The second limiter is arranged at the distal end of the stent body, and is arranged to limit the movement of the valve stent toward the proximal end when the valve stent is in the working state.

[0043] In this embodiment, the second limiting member includes a valve clip 112 and a limiting rod 113 provided at the distal end of the stent body. The valve clip 112 is an integrally formed valve clip, which is detachably connected to the stent body 111. Specifically, the stent body 111 includes three first connecting portions 1111, the valve clip includes three connecting portions 1121 and three clamping portions 1122, the second connecting portion 1121 corresponds to the first connecting portion 1111, and the two are detachably connected, so that the valve clip is detachably connected to the stent body 111, and the clamping portion 1122 is configured to restrict the human valve leaflet between the stent body and the valve clip when the valve stent is in a working state. In the present embodiment, the clamping parts 1122 are all V-shaped, each clamping part has an arc bottom located at the proximal end and a pair of tops extending from the arc bottom to the distal end, the tops of adjacent clamping parts are connected to form an arc top, and the second connecting part 1121 is arranged on the arc top and extends to the distal end. In the present embodiment, the first connecting part 1111 is evenly distributed along the circumference of the bracket body, the second connecting part 1121 corresponds to the first connecting part 1111, and the three clamping parts 1122 are V-shaped clamps of the same size. In an optional embodiment, the first connecting part 1111 can also be unevenly distributed, and the clamping part 1122 can also change the size according to actual needs.

[0044] In this embodiment, the bracket body further includes a connecting piece, and the first connecting portion 1111 and the second connecting portion 1121 are detachably connected via the connecting piece. FIG. 3A to FIG. 3BAs shown, the first connecting portion 1111 and the second connecting portion 1121 are both elastic open deformable parts, and the connecting part is a sleeve 116 having a through accommodating cavity 1161 and a distal end of the sleeve extending to form a bendable limiting portion 1162 . The first connecting portion 1111 has a protrusion 1113 at the opening and a protrusion 1114 near the connection, and the second connecting portion 1121 is also provided with a protrusion corresponding to the first connecting portion, that is, a protrusion 1123 at the opening and a protrusion 1124 near the connection. The accommodating cavity 1161 of the sleeve is configured to allow the protrusions 1113 and 1123 of the first connecting portion 1111 and the second connecting portion 1121 to pass through after deformation. After the protrusions 1113 and 1123 of the first connecting portion 1111 and the second connecting portion 1121 pass through the accommodating cavity, they will be elastically released and stuck outside the sleeve again, so that the protrusions 1113 and 1123 limit the movement of the sleeve 116 toward the distal end, and the protrusions 1114 and 1124 limit the movement of the sleeve 116 toward the proximal end, and the limiting portion 1162 of the sleeve 116 is configured to be stuck at the elastic openings of the first connecting portion 1111 and the second connecting portion 1121 after bending to limit the deformation of the elastic opening again. The valve clip 112 is detachably connected to the stent body 111 by biasing and deforming the openings with protrusions of the first connection part 1111 and the second connection part 1121, inserting them into the sleeve 116, and bending the limiting part 1162 and clamping it at the opening of the connection part. In an optional embodiment, the connecting member can also be other parts that can detachably connect the first connection part 1111 and the second connection part 1121, such as sutures, metal ring buckles, rubber rings, etc. The first connection part 1111 and the second connection part 1121 can also be elastic parts of other forms, and the movement of the connecting member can also be limited by other methods.

[0045] During actual use, the sleeve 116 is assembled on the second connecting part 1121 of the valve clip, and whether to install the valve clip can be selected as needed; when the valve clip needs to be installed, the first connecting part 1111 of the bracket component is squeezed into the accommodating cavity of the sleeve through external force bias, and then the limiting part 1161 of the sleeve is bent and clamped to the first connecting part and the second connecting part to prevent the sleeve from loosening.

[0046] In this embodiment, three limiting rods 113 are located at the "large opening" of the stent body for the reserved channel for subsequent coronary procedures. Each limiting rod 113 includes a connecting end 1131 and a free end 1132. The connecting end is fixedly connected to the stent body, and the free end extends outward from the stent body 111 so that the limiting rod 113 is suitable for axially pressing the human valve leaflet when the valve stent is in the working state. In this way, the limiting rod 113 can form a hook-like structure at the "large opening" of the stent body, such as Figure 2As shown, when encountering human valve leaflets, the limiting rod 113 can press the valve leaflets to prevent the stent from moving toward the ventricle (proximal end). In an optional embodiment, the free end of the limiting rod can also be provided with a barb, which is configured to be suitable for clamping the human valve leaflets when the valve stent is in a working state to further prevent the stent from moving toward the ventricle (proximal end). In this embodiment, three limiting rods 113 are evenly distributed along the circumference of the stent body, and the limiting rods 113 are in an inverted V shape, with a pair of connecting ends 1131 fixedly connected to the stent body and a free end 1132 extending from the connecting end 1131 to the distal end and obliquely extending toward the outside of the stent body 111, and the free end 1132 has an arc design to avoid scratching the human valve leaflets.

[0047] Since the valve clip is detachably connected to the stent body, it is possible to choose whether to use the valve clip as needed. When the valve clip is retained, the valve graft can be used to treat not only pure regurgitation, but also insufficiency caused by valvular leaflet calcification; when the valve clip is separated from the stent body and not used, the valve graft can be better used for insufficiency caused by valvular leaflet calcification.

[0048] In this embodiment, the first limit member includes a plurality of support members 114 and a plurality of encryption rods 115. Figure 1 to Figure 2 The support member 114 is arranged along the circumference of the stent body and fixedly connected to the stent body 111. It is arranged to expand outward from the stent body 111 when the valve stent is in a released state to limit the movement of the valve stent toward the distal end. The support member can be used to support the sealing skirt (not shown). In this way, the valve stent can be effectively prevented from moving toward the aorta (distal end), and the occurrence of paravalvular leakage can be effectively reduced or eliminated. In an optional embodiment, an encryption rod 115 fixedly connected to the stent body 111 is also arranged between adjacent support members 114 to increase the sealing effect.

[0049] The distal end of the stent body is also provided with an interface portion 1112 for the delivery system to clamp, and the first connection portion 1111 can be provided at the interface portion. The interface portion is in an inverted V shape, having a pair of connection ends fixedly connected to the stent body and a free end arc top extending from the connection end to the distal end, and the arc top of the interface portion is concave inward to prevent the top of the stent from contacting the ascending aorta and irritating the blood vessel.

[0050] The skeleton structure of the valve graft composed of the stent body 111, the limiting rod 113, the support member 114, and the encryption rod 115 is formed in one piece, for example, stainless steel or nickel-titanium alloy elastic material is used and obtained by laser cutting. Optionally, at least any two of the limiting rod 113, the support member 114, the encryption rod 115 and the stent body 111 are formed in one piece. The integrated formation method can reduce the outer diameter of the valve graft in a compressed state for transportation, and facilitates the introduction into the blood vessel. In other embodiments, the support member, the limiting rod, etc. can be fixedly connected to the stent body in other ways. For example, the limiting member is fixed to the stent body by welding.

[0051] [Example 2]

[0052] Combine the following Figures 4 to 6B The heart valve implant according to the second embodiment of the present invention will be described in detail. Figure 4 is a cross-sectional schematic diagram of a heart valve graft according to Example 2 of the present invention located in a blood vessel; Figure 5 It is shown Figure 4 Schematic diagram of a valve clip of a heart valve graft shown; Fig. 6A and Figure 6B Schematic diagram of two connection methods of the valve clip and the valve stent.

[0053] The difference between the heart valve graft 2 in this embodiment and the heart valve graft 1 in embodiment 1 mainly lies in the detachable connection between the valve clip and the stent body.

[0054] like Figure 4 As shown, the heart valve graft 2 includes a valve stent 21 and an artificial valve leaflet 22 located inside the valve stent 21. The valve stent 21 includes a stent body 211, a first stopper (a plurality of support members 214 and a plurality of encrypted rods 215), and a second stopper (a valve clip 212 and a stopper rod 213). The stent body 211 has an internal channel in the expanded state, and the artificial valve leaflet 22 is connected in the internal channel.

[0055] In this embodiment, the valve clip 212 is an integrally formed valve clip, which is detachably connected to the stent body 111. Specifically, the stent body 211 includes three first connecting parts 2111, the valve clip includes three second connecting parts 2121 and three clamping parts 2122, the second connecting parts 2121 correspond to the first connecting parts 2111, and the two are detachably connected, so that the valve clip is detachably connected to the stent body 211, and the clamping parts 2122 are configured to restrict the human valve leaflets between the stent body and the valve clip when the valve stent is in a working state. In this embodiment, the clamping parts 2122 are all V-shaped, each clamping part has an arc bottom located at the proximal end and a pair of tops extending from the arc bottom to the distal end, the tops of adjacent clamping parts are connected to form an arc top, and the second connecting part 2121 is arranged on the arc top and extends to the distal end. In this embodiment, the first connection parts 2111 are evenly distributed along the circumference of the bracket body, the second connection parts 2121 correspond to the first connection parts 1111, and the three clamping parts 2122 are V-shaped clamps of the same size. In an optional embodiment, the first connection parts 2111 can also be unevenly distributed, and the clamping parts 2122 can also change their sizes according to actual needs.

[0056] Each first connection part 2111 is provided with a first hole 2112, each second connection part is provided with a second hole 2123, and the first connection part and the second connection part are detachably connected by a connection member. For example, the connection member is a suture thread that can pass through the first hole and the second hole, and the suture thread passes through the first hole and the second hole to sew the first connection part and the second connection part together (such as Fig. 6A In an optional embodiment, the connector is a metal ring buckle that can pass through the first hole and the second hole. The metal ring buckle is used to pass through the first hole 2112 and the second hole 2123 so that the valve clip is buckled to the stent body, that is, the metal ring buckle with a gap is used to cover the first hole and the second hole, and then the gap of the metal ring is closed by external force (such as Figure 6B Thus, if the valve graft is installed with a detachable valve clip when it leaves the factory, the valve clip is easy to remove and can be removed at the surgical site as needed; or if the valve clip is separated from the stent body when it leaves the factory, the corresponding design of the first hole and the second hole also makes it easy to install the valve clip at the surgical site.

[0057] In this embodiment, if Figure 5 As shown, the bottom of the clamping portion of the valve clip includes a recessed portion 2124, which is concave toward the stent body and is configured to clamp the human valve leaflets to the outside of the stent body when the valve stent is in the working state. Such a recessed portion can concentrate most of the force to the bottom of the valve leaflets, which can increase the clamping force on the one hand, and enable the human valve leaflets to tightly wrap around the outside of the stent body on the other hand, thereby reducing the occurrence of paravalvular leakage.

[0058] [Example 3]

[0059] Combine the following Figures 7 and 8 The heart valve transplant according to the third embodiment of the present invention will be described in detail. Figure 7 is a cross-sectional schematic diagram of a heart valve graft according to Example 3 of the present invention located in a blood vessel, Figure 8 is a schematic top view of the heart valve transplant.

[0060] The difference between the heart valve graft 3 in this embodiment and the heart valve graft 1 in embodiment 1 is that the valve clip is omitted. The valve support 31 may be an outer covering, which is not shown in the figure for the sake of convenience.

[0061] like Figure 7 As shown, the heart valve graft 3 includes a valve stent 31 and an artificial valve leaflet 32 ​​located inside the valve stent 31. The valve stent 31 includes a stent body 311, a first stopper and a second stopper, wherein the first stopper includes a plurality of support members 313 and a plurality of encrypted rods 314, and the second stopper includes three stopper rods 312. The stent body 311 has an internal channel in the expanded state, and the artificial valve leaflet 32 ​​is connected in the internal channel.

[0062] In this embodiment, the valve clip is omitted, and only the design of the limiting rod is retained. The limiting rod 312 includes a connecting end and a free end. The connecting end is fixedly connected to the stent body 311, and the free end extends outward from the stent body 311 so that the limiting rod 312 extends radially and presses the human valve leaflet axially when the valve stent is in the working state. Figure 7 As shown, the free end of the stopper is provided with a barb 3121, which is configured to catch the human valve leaflet when the valve stent is in the working state, so that when encountering a calcified human valve leaflet (A region), the stopper rod 312 will hang on the valve leaflet, fix the stent to prevent it from moving toward the ventricle (proximal end). In an optional embodiment, the design of the barb can also be omitted.

[0063] Since the valve clip is detachably connected to the stent body, you can choose whether to use the valve clip as needed. When the valve clip is retained, the valve graft can be used to treat pure regurgitation and insufficiency caused by valvular calcification in addition to pure regurgitation. When the valve clip is separated from the stent body and not used, the valve graft can be better used for insufficiency caused by valvular calcification. At this time, the outward expansion of the support plays a role in sealing and preventing the valve graft from moving toward the aorta, and the limit rod plays a role in preventing the valve graft from moving toward the ventricle.

[0064] [Example 4]

[0065] Combine the following Figures 9 to 12The heart valve implant according to the fourth embodiment of the present invention will be described in detail. Fig. 9 is a perspective schematic diagram of a heart valve implant according to Example 4 of the present invention; Fig.10 It is shown Fig. 9 Schematic diagram of a valve clip of a heart valve graft shown; Fig.11 yes Fig. 9 A cross-sectional schematic diagram of a heart valve graft shown positioned in a blood vessel; Fig.12 is a schematic diagram of another embodiment of a valve clip.

[0066] The difference between the heart valve graft 4 in this embodiment and the heart valve graft 1 in Embodiment 1 mainly lies in the design of the valve clip.

[0067] like Figures 9 to 11 As shown, the heart valve graft 4 includes a valve stent 41 and an artificial valve leaflet 42 located inside the valve stent 41. The valve stent 41 includes a stent body 411, a first stopper (a support member 414 and a densifying rod 415), and a second stopper (a valve clip 412 and three stopper rods 413). The stent body 411 has an internal channel in the expanded state, and the artificial valve leaflet 42 is connected in the internal channel.

[0068] In this embodiment, the valve clip 412 is an integrally formed valve clip, which is detachably connected to the stent body 411. The stent body 411 includes three first connecting parts 4111, the valve clip includes three connecting parts 4121 and three clamping parts 4122, the second connecting part 4121 corresponds to the first connecting part 4111, and the two are detachably connected, so that the valve clip is detachably connected to the stent body 411, and the clamping part 4122 is configured to restrict the human valve leaflet between the stent body and the valve clip when the valve stent is in a working state. In this embodiment, the clamping parts 4122 are all V-shaped, each clamping part has an arc bottom located at the proximal end and a pair of tops extending from the arc bottom to the distal end, the tops of adjacent clamping parts are connected to form an arc top, and the second connecting part 4121 is arranged on the arc top and extends to the distal end. In this embodiment, the first connection parts 4111 are evenly distributed along the circumference of the bracket body, the second connection parts 4121 correspond to the first connection parts 4111, and the three clamping parts 4122 are V-shaped clamps of the same size. In an optional embodiment, the first connection parts 4111 can also be unevenly distributed, and the clamping parts 4122 can also change their sizes according to actual needs.

[0069] In this embodiment, a clamping reinforcement piece 4123 is provided in the center of each clamping portion 4122 of the valve clip, and the clamping reinforcement piece 4123 is configured to clamp the human valve leaflets to the outside of the stent body when the valve stent is in the working state. Specifically, the clamping reinforcement piece 4123 has a connecting end and a free end, the connecting end of the clamping reinforcement piece is fixedly connected to the arc bottom of the clamping portion, and the free end of the clamping reinforcement piece extends from the clamping portion to the distal end of the stent, and is configured to press against the human valve leaflets when the valve stent is in the working state, and the connecting end of the clamping reinforcement piece is a single rod design, and the free end is annular, such a round head design can avoid penetrating the human valve leaflets.

[0070] In this way, the clamping reinforcement piece 4123 and the limiting rod 413 cooperate to clamp the human valve leaflet between the clamping reinforcement piece and the limiting rod. On the one hand, it plays a role of strengthening the fixation. On the other hand, in case the human valve leaflet is torn, it can prevent the valve leaflet from floating, so as to reduce the risk of the valve leaflet blocking the coronary orifice. In an optional embodiment, the bottom of the valve clamp may also include a recessed portion (as shown in Example 1). In an optional embodiment, the valve clamp may also be a single valve clamp independent of each other. In an optional embodiment, the connecting end of the clamping reinforcement piece 4123 may be a double-rod design (such as Fig.12 shown).

[0071] [Example 5]

[0072] Combine the following Fig.13 The valve clip of the heart valve graft according to the fifth embodiment of the present invention will be described in detail. Fig.13 4 is a schematic three-dimensional diagram of a valve clip of a heart valve transplant according to Example 5 of the present invention.

[0073] The difference between the heart valve graft in this embodiment and the heart valve graft in Embodiment 1 is mainly that the valve clip is further provided with a developing point.

[0074] like Fig.13 As shown, the valve clip 512 has three connecting parts 5121 and three clamping parts 5122. The connecting parts 5121 are elastic opening deformable parts extending from the top of the arc to the distal end. The arc bottom of the clamping parts 5122 is provided with through holes 5123. These through holes are filled with developing materials, so that the bottom of the clamping parts has developing points, which is convenient for observing the position of the bottom of the clamping parts in the human body during the release process, so as to judge whether the arc bottom reaches the sinus of the human valve leaflet. In the present invention, the developing material can be a high-density metal, such as gold, platinum, tantalum, palladium, iridium, tungsten, or a combination thereof, such as platinum-iridium alloy, platinum-tungsten alloy, etc.

[0075] Those skilled in the art should understand that what is disclosed above is only an implementation mode of the present invention, and it certainly cannot be used to limit the scope of rights of the present invention. Equivalent changes made according to the implementation mode of the present invention are still within the scope covered by the claims of the present invention.

Claims

1. A heart valve graft, comprising a valve stent and an artificial valve leaflet located inside the valve stent, characterized in that: The valve support comprises: The support body; A first stopper, which is arranged at the proximal end of the stent body and is arranged to limit the valve stent from moving toward the distal end when the valve stent is in a working state; A second limiting member, which is arranged at the distal end of the stent body and is arranged to limit the valve stent from moving toward the proximal end when the valve stent is in a working state; Wherein, the stent body includes at least one first connection part, the second stopper includes a valve clip, the valve clip includes at least one second connection part and at least one clamping part, the first connection part and the second connection part are configured to be detachably connected, and the clamping part is configured to limit the human valve leaflet between the stent body and the valve clip when the valve stent is in a working state; The bracket body further includes a connecting piece, and the first connecting part and the second connecting part are detachably connected through the connecting piece; The first connecting part and the second connecting part are both elastic opening deformable parts with protrusions, the connecting part is a sleeve, the sleeve has a through accommodating cavity, and the distal end of the sleeve extends to form a bendable limiting portion, the accommodating cavity is configured to allow the protrusions of the first connecting part and the second connecting part to pass through after deformation, the protrusions are configured to limit the movement of the connecting part, and the limiting portion is configured to limit the deformation of the elastic openings of the first connecting part and the second connecting part after bending; A clamping reinforcement piece is arranged in the center of the clamping part of the valve clamp, and the clamping reinforcement piece has a connecting end and a free end. The connecting end of the clamping reinforcement piece is fixedly connected to the clamping part, and the free end of the clamping reinforcement piece extends from the clamping part to the distal end of the stent. The clamping reinforcement piece is arranged to clamp the human valve leaflet to the outside of the stent body when the valve stent is in a working state.

2. The heart valve implant according to claim 1, wherein: The first connecting portion is provided with a first hole, the second connecting portion is provided with a second hole, and the connecting member is a suture or a metal buckle that can pass through the first hole and the second hole.

3. The heart valve implant according to claim 1, wherein: The bottom of the clamping portion of the valve clip includes a recessed portion, which is configured to clamp the human valve leaflet to the outside of the stent body when the valve stent is in a working state.

4. The heart valve implant according to claim 1, wherein: The second limiting member includes at least one limiting rod having a connecting end and a free end, wherein the connecting end is fixedly connected to the stent body, and the free end extends outward from the stent body so that the limiting rod can axially press against the human valve leaflet when the valve stent is in a working state.

5. The heart valve implant according to claim 4, wherein: The free end of the limiting rod is provided with a barb, and the barb is configured to be suitable for clamping the human valve leaflet when the valve support is in a working state.

6. The heart valve implant according to claim 1, wherein: The first limiting member includes a plurality of support members, which are arranged along the circumference of the stent body and fixedly connected to the stent body. The support members are arranged to expand outward from the stent body when the valve stent is in a working state to limit the movement of the valve stent toward the distal end, and encryption rods fixedly connected to the stent body are arranged between adjacent support members.

7. The heart valve implant according to claim 1, wherein: The distal end of the stent body is provided with an interface for clamping by a conveying system.

8. The heart valve implant according to claim 1, wherein: A through hole is provided at the bottom of the clamping portion of the valve clip, and the through hole is filled with developing material.

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