Stent implant for prosthetic heart valve and prosthetic heart valve

Abstract

The present invention relates to a stent implant for a prosthetic heart valve and a prosthetic heart valve. The stent implant comprises a stent main body, a positioning member, and a connecting member. At least three first connecting holes are provided in the stent main body in the circumferential direction of the stent main body. The positioning member is located on an outer side of the stent main body. The positioning member is arranged around the stent main body in the circumferential direction of the stent main body when expanded, and at least three second connecting holes are provided on the positioning member in the circumferential direction of the stent main body. One end of the connecting member movably penetrates all of the first connecting holes and all of the second connecting holes and is then connected with the other end, and the extension state of the connecting member may be adaptively adjusted on the basis of the radial telescopic motion of the stent implant, so that the position of the positioning member is enabled to be adaptively adjusted relative to the stent main body. Therefore, the relative positions of the positioning member and the stent main body may be autonomously adjusted in different stages without the need to additionally control the connecting member, thereby simplifying intraoperative operation while ensuring positioning accuracy and reliability.

Description

Stent implant for artificial heart valve and artificial heart valve Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a stent implant for an artificial heart valve and an artificial heart valve. Background Art

[0002] The heart contains four chambers: the right atrium (RA), right ventricle (RV), left atrium (LA), and left ventricle (LV). The pumping action of the left and right sides of the heart generally occurs synchronously throughout the cardiac cycle. The valves separating the atria from the ventricles are called the atrioventricular valves. They act as one-way valves, ensuring the normal flow of blood within the heart chambers. The atrioventricular valve between the left atrium and the left ventricle is the mitral valve, and the atrioventricular valve between the right atrium and the right ventricle is the tricuspid valve. The pulmonary valve directs blood flow to the pulmonary artery, and from there to the lungs; blood returns to the left atrium through the pulmonary veins. The aortic valve directs blood flow through the aorta, and from there to the pericardium. There are typically no direct connections between the ventricles or between the atria. At the beginning of ventricular filling (diastole), the aortic and pulmonary valves close to prevent backflow from the arteries into the ventricles. Shortly thereafter, the atrioventricular valves open to allow unimpeded flow from the atria into the corresponding ventricles. Shortly after the onset of ventricular systole (ie, ventricular emptying), the tricuspid and mitral valves normally close, forming a seal that prevents backflow from the ventricles into the respective atria.

[0003] The failure of the valve leaflets to seal during ventricular contraction is called malcoaptation, which can allow blood to flow backward through the valve (regurgitation). Heart valve insufficiency can have serious consequences for patients, often leading to heart failure, reduced blood flow, lowered blood pressure, and / or reduced oxygen flow to tissues. Aortic valve insufficiency can also cause blood to flow back from the left atrium into the pulmonary veins, causing congestion. Severe valvular insufficiency, if left untreated, can lead to permanent disability or death. Transcatheter aortic valve replacement (TAVR) has rapidly developed in recent years and has gradually gained prominence in the treatment of aortic stenosis (AS). It is also used to treat selected patients with AR (aortic regurgitation), and is recommended in national and international guidelines. Unlike in Western countries, AR is no less common than AS in clinical practice in my country. Based on data from the China Valvular Heart Disease Registry (China-DVD Study), researchers conducted the first nationwide survey of elderly patients with valvular heart disease from September to December 2016, recruiting nearly 9,000 hospitalized patients aged 60 and above from 69 hospitals across 28 provinces, municipalities, and autonomous regions across China. Among them, patients with isolated aortic regurgitation (PAR) accounted for 10.2%, and patients with AS accounted for 5.1%. Among patients with severe valvular diseases, the proportion of AR and AS patients was similar. Although TAVR has developed rapidly in my country in recent years, it is still difficult to use it in patients with isolated aortic regurgitation (PAR) who are contraindicated or high-risk for surgery, as well as patients with PAR with suitable anatomical structures. Most PAR patients have large valve rings and severely dilated aortas that cannot be closed, which can easily cause regurgitation and device-related thrombosis. These patients have larger ventricles, increased stroke volume, and great hemodynamic impact. In addition, the calcification conditions that are conducive to anchoring are insufficient. Basically, the leaflets have no calcification or very little calcification. In this case, anchoring is difficult to achieve aortic valve replacement. In addition, existing artificial heart valves also have complex structures and cumbersome delivery operations.

[0004] Therefore, for those skilled in the art, how to design an artificial heart valve and its stent implant that can target aortic valve regurgitation, achieve reliable anchoring, and simplify the delivery operation is a technical problem that needs to be solved urgently.

[0005] It should be noted that the information disclosed in the background technology section of this application is intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of implication that the information constitutes prior art already known to those skilled in the art.

[0006] Summary of the Invention

[0007] In view of the above technical problems, the purpose of the present invention is to provide a stent implant and an artificial heart valve for an artificial heart valve, which can be used to replace a simple aortic regurgitation valve, achieve stable and reliable fixation through a unique anchoring method, and simplify intraoperative operations.

[0008] To achieve the above-mentioned objectives, the present invention provides a stent implant for an artificial heart valve, which has an expanded state and a compressed state, and is characterized in that it includes a stent body, a positioning member and a connecting member; the stent body is provided with at least three first connecting holes along its own circumference; the positioning member is located on the outside of the stent body, and the positioning member is arranged around the stent body along the circumference of the stent body when expanded; the positioning member is provided with at least three second connecting holes along the circumference of the stent body; one end of the connecting member can movably pass through all the first connecting holes and all the second connecting holes and then be connected to the other end; the connecting member can adaptively adjust the extension state based on the radial telescopic movement of the stent implant, thereby enabling the positioning member to adaptively adjust its position relative to the stent body.

[0009] In one embodiment, when the stent implant is in an expanded state, the connector extends continuously in the circumferential direction of the stent body, and the positioning member is arranged within the axial height range of the stent body; when the stent implant is in a compressed state during delivery, a portion of the connector extends in the circumferential direction of the stent body, and another portion of the connector extends axially outside the stent body, and the positioning member is located in front of the inflow end of the stent body and is arranged outside the axial height range of the stent body.

[0010] In one embodiment, all the first connection holes are provided at the outflow end of the bracket body and arranged on the outside of the bracket body, and all the first connection holes are distributed on the same circumferential surface and are evenly distributed.

[0011] In one embodiment, the outflow end of the stent body is provided with a plurality of delivery connection parts, and the position of the first connection hole corresponds to the position of at least part of the delivery connection parts.

[0012] In one embodiment, all the second connection holes are provided at the outflow end of the positioning member, and all the second connection holes are distributed on the same circumferential surface and are evenly distributed.

[0013] In one embodiment, the number of the first connection holes and the number of the second connection holes are both three, and the three first connection holes and the three second connection holes are evenly distributed along the circumference of the bracket body.

[0014] In one embodiment, the positioning member includes three positioning feet, and the three positioning feet are distributed along the circumference of the bracket body. Each positioning foot is a rod structure and can be folded and unfolded.

[0015] In one embodiment, the inflow ends of the three positioning pins are used to be inserted into the three sinuses of the aortic valve for anchoring in a one-to-one correspondence.

[0016] In one embodiment, each of the positioning legs is a V-shaped structure.

[0017] In one embodiment, the surface of the connector is treated with anticoagulant treatment.

[0018] Based on the same inventive concept, the present invention also provides an artificial heart valve, which includes any one of the stent implants for an artificial heart valve.

[0019] The present invention also provides a method for delivering an artificial heart valve, comprising:

[0020] The artificial heart valve is delivered to the aortic root by a delivery system. During the delivery process, the positioning member is moved to the front of the inflow end of the stent body and arranged outside the height range of the stent body.

[0021] After reaching the aortic root, the delivery system is rotated so that the positioning member is aligned with the aortic sinus floor. Then, the entire artificial heart valve is separated from the sheath of the delivery system. The positioning member is first released, and the positioning member is radially expanded. Under the action of the connecting member, the positioning member is moved to within the height range of the stent body and arranged around the stent body, while maintaining the connection between the delivery guide wire of the delivery system and the outflow end of the stent body.

[0022] After the positioning piece is released, the delivery guidewire continues to push the entire artificial heart valve forward until the inflow end of the positioning piece enters the sinus of the aortic valve;

[0023] After confirming that the position of the stent body is correct, the connection between the delivery guide wire and the stent body is released to release the entire artificial heart valve, thereby allowing the stent body to expand radially, and further tighten the connecting parts to finally fix the relative position of the positioning part and the stent body.

[0024] Compared with the prior art, the stent implant for an artificial heart valve and the artificial heart valve provided by the present invention have at least the following beneficial effects:

[0025] In the above stent implants, the connection between the stent body, the positioning member and the connecting member is achieved through multiple first connecting holes and multiple second connecting holes, and the relative positions of the three are constrained, so that the movement trajectory and posture of the connecting member can be precisely controlled, while also ensuring the stability and rigidity of the connection, and ensuring the reliability and positioning accuracy of the stent implant.

[0026] In the aforementioned stent implants, after the connector is connected to the positioning member and the stent body, the connector remains movable relative to the positioning member and the stent body, enabling the connector to adaptively adjust its extension state based on the radial expansion and contraction of the stent implant, thereby also enabling the positioning member to adaptively adjust its position relative to the stent body. This allows the stent implant to adjust the relative position of the positioning member and the stent body during surgery without requiring additional control of the connector. Consequently, this delivery method eliminates the need for complex control operations, offers a simple structure, high reliability, and precise positioning.

[0027] In addition, the provision of the positioning piece also enables the stent implant to achieve aortic valve replacement for patients with pure reflux who are difficult to anchor. The positioning piece can extend into the bottom of the aortic sinus, not only for initial positioning, but also to provide anchoring force, thereby achieving precise positioning of the artificial heart valve and stable and reliable anchoring of the artificial heart valve at the aortic valve.

[0028] Since the artificial heart valve provided by the present invention and the stent implant provided by the present invention belong to the same inventive concept, the artificial heart valve provided by the present invention has at least all the advantages of the stent implant provided by the present invention, which will not be described in detail here. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG1 is a schematic diagram of the overall structure of a stent implant for an artificial heart valve in an expanded state according to an embodiment of the present invention;

[0030] FIG2 is a front view of the stent implant for an artificial heart valve in FIG1 in an expanded state;

[0031] FIG3 is a top view of the stent implant for an artificial heart valve in FIG2 in an expanded state;

[0032] FIG4 is a schematic structural diagram of a stent body of a stent implant for an artificial heart valve according to an embodiment of the present invention;

[0033] FIG5 is a schematic structural diagram of a positioning member of a stent implant for an artificial heart valve according to an embodiment of the present invention;

[0034] 6 is a schematic diagram of a delivery system and an artificial heart valve therein according to an embodiment of the present invention being delivered to the aortic root via the femoral artery;

[0035] FIG7 is a diagram of the prosthetic heart valve of FIG6 in a compressed state when delivered within the delivery system;

[0036] FIG8 is a schematic diagram showing a state where the sheath is withdrawn and the positioning member is released first according to an embodiment of the present invention;

[0037] FIG9 is an intermediate state of the stent implant in FIG8 , wherein the positioning member is released and deployed and moved to the outer peripheral side of the stent body;

[0038] FIG10 is a top view of the stent implant in FIG9 ;

[0039] FIG11 is a schematic diagram of a state where the artificial heart valve continues to be pushed forward until it reaches the native aortic valve according to an embodiment of the present invention;

[0040] FIG12 is a schematic diagram of a state in which the artificial heart valve is completely released and positioned independently on the native aortic valve according to an embodiment of the present invention;

[0041] FIG. 13 shows the stent implant of the artificial heart valve in FIG. 12 in an expanded state when positioned. DETAILED DESCRIPTION

[0042] To make the content of the present invention more clear and understandable, the present invention is further described below in conjunction with the accompanying drawings. Of course, the present invention is not limited to the following specific embodiments, and general replacements known to those skilled in the art are also included in the scope of protection of the present invention.

[0043] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. The singular forms "a", "said" and "the" used in this application are also intended to include the plural forms, unless the context clearly indicates otherwise. It should be understood that similar words such as "a" or "an" do not indicate a quantity limitation, but rather indicate the presence of at least one; "plurality" indicates a quantity of two or more. Similar words such as "include" or "comprises" mean that the elements or objects appearing before "include" or "comprises" cover the elements or objects listed after "include" or "comprises" and their equivalents, and do not exclude other elements or objects. Secondly, the present invention is described in detail using schematic diagrams, but these schematic diagrams are only for the convenience of detailing the embodiments of the present invention and should not be used as limitations of the present invention.

[0044] The "circumferential direction" described in this application document corresponds to the circumferential direction of the stent implant; the "radial direction" corresponds to the diameter direction of the stent implant; the "axial direction" corresponds to the axial direction of the stent implant, with the axial direction being perpendicular to the radial direction; the terms "inflow end" and "outflow end" are defined by the position of the artificial heart valve relative to the native valve after implantation. According to the normal direction of blood flow, the "inflow end" is the end where blood flows into the artificial heart valve, and the "outflow end" is the end where blood flows out of the artificial heart valve. The inflow end of the artificial heart valve includes the inflow end of the stent body and the inflow end of the positioning member, and the outflow end of the artificial heart valve includes the outflow end of the stent body and the outflow end of the positioning member. The "inside" described in this application document refers to the side close to the axis of the stent implant, and the "outside" refers to the side away from the axis of the stent implant.

[0045] The core of the present invention is to provide a stent implant for an artificial heart valve and an artificial heart valve to solve the existing problems of difficult anchoring, complex structure and cumbersome delivery operation for aortic valve regurgitation.

[0046] The following is a description with reference to the accompanying drawings.

[0047] As shown in Figures 1 to 5, an embodiment of the present invention provides a stent implant 100 for an artificial heart valve, wherein the stent implant 100 comprises a stent body 110, a positioning member 120 and a connector 130. The stent implant 100 has an expanded state and a compressed state, and can be converted between the expanded state and the compressed state. The expanded state comprises the expanded state when the stent implant 100 is constrained by an external force, and the free expanded state when the stent implant 100 is not constrained by an external force. The compressed state generally refers to the contracted state when the stent implant 100 is delivered in a conveying system 200 (see Figure 6).

[0048] The stent body 110 is a mesh structure, mostly using a diamond-shaped grid, which is responsible for carrying the valve (not shown) and skirt (not shown) of the artificial heart valve. The stent body 110 is woven or cut. The material of the stent body 110 is not limited. For example, it can be made of nickel-titanium alloy or other biocompatible materials with shape memory properties. It can also be made of elastically or plastically deformable polymer materials, such as balloon-expandable materials (commonly used balloon materials). Usually, a metal material with good elasticity is selected to prepare the stent body 110 so that the stent body 110 can self-expand.

[0049] As shown in Figures 2 and 4, at least three first connection holes 111 are provided along the circumference of the bracket body 110. In this embodiment, all first connection holes 111 are provided at the outflow end 110A of the bracket body 110. In other embodiments, all first connection holes 111 may be provided at an intermediate position between the outflow end 110A and the inflow end 110B of the bracket body 110. This intermediate position should not be narrowly understood as an absolute midpoint, but rather any position between the outflow end 110A and the inflow end 110B. Generally, the first connection holes 111 are provided adjacent to the outflow end 110A of the bracket body 110, or directly at the outflow end 110A. The first connection holes 111 are typically provided on the outside of the bracket body 110 so that the connector 130 can be routed outside the bracket body 110. Preferably, all first connection holes 111 are distributed on the same circumferential surface and are evenly distributed, thereby better constraining the connector 130 and allowing it to be well tightened and not easily loosened. Preferably, the number of the first connecting holes 111 is three. The relative positions of the stent body 110 and the connecting member 130 can be fixed through the three first connecting holes 111, and the moving trajectory and posture of the connecting member 130 can be precisely controlled. At the same time, the stability and rigidity of the connection can be guaranteed, thereby improving the reliability and positioning accuracy of the stent implant 100.

[0050] As shown in Figures 1 to 3, the positioning member 120 is located outside the stent body 110. When the stent implant 100 is deployed, the positioning member 120 is arranged circumferentially around the stent body 110 to provide sufficient anchoring force. As shown in Figure 5, the positioning member 120 is provided with at least three second connection holes 121 along its circumference. It should be understood that the circumference of the positioning member 120 corresponds to the circumference of the stent body 110, and the axial direction of the positioning member 120 corresponds to the axial direction of the stent body 110. In this embodiment, all second connection holes 121 are located at the outflow end 122 of the positioning member 120. Preferably, all second connection holes 121 are distributed on the same circumferential surface and are evenly spaced, so that the connector 130 can effectively constrain the positioning member 120 and ensure positioning accuracy. Preferably, there are three second connection holes 121. These three second connection holes 121 can fix the relative position of the positioning member 120 and the connector 130, thereby indirectly fixing the relative position of the positioning member 120 and the stent body 110.

[0051] During installation, one end of the connector 130 can be movably passed through all the first connection holes 111 and all the second connection holes 121 and then connected to the other end, that is, the head and tail ends of the connector 130 are interconnected to form a closed loop. After the connector 130 is connected to the positioning member 120 and the stent body 110, the connector 130 can still move relative to the positioning member 120 and the stent body 110. This facilitates the connector 130 to adaptively adjust its extension state based on the radial telescopic movement of the stent implant 100, and further enables the positioning member 120 to adaptively adjust its position relative to the stent body 110. The "adaptive adjustment" of the connector 130 refers to the automatic adjustment of the extension direction according to the shape of the positioning member 120 and the stent body 110 during the delivery and release of the stent implant 100, so that the relative position of the connector 130, the positioning member 120 and the stent body 110 is adapted. In this way, during the operation, the relative positions of the positioning member 120 and the stent body 110 can be adjusted at different stages without the need for additional control of the connecting member 130. This delivery method does not require complex control operations, has a simple structure, high reliability, and precise positioning.

[0052] In addition, the provision of the positioning member 120 also enables the stent implant 100 to achieve aortic valve replacement for patients with pure reflux who are difficult to anchor. The positioning member 120 can extend into the bottom of the aortic sinus, not only for initial positioning, but also to provide anchoring force, thereby achieving precise positioning of the artificial heart valve and stable and reliable anchoring of the artificial heart valve at the aortic valve.

[0053] 1 to 3 , when the stent implant 100 is in the expanded state, the connectors 130 extend continuously along the circumference of the stent body 110. At this time, the connectors 130 are only arranged along the circumference of the stent body 110 and are in a taut state. The connectors 130 have a restraining effect on the stent body 110. Conversely, the expansion of the stent body 110 also tightens the connectors 130. Simultaneously, the connectors 130 also fix the relative position of the positioning member 120 and the stent body 110. Preferably, when the stent implant 100 is in the expanded state, the positioning member 120 is arranged within the axial height range of the stent body 110. In other words, the inflow end 123 of the positioning member 120 does not extend beyond the inflow end 110B of the stent body 110. That is, the inflow end 123 of the positioning member 120 is higher than the inflow end 110B of the stent body 110. This helps improve sealing and prevent paravalvular leakage.

[0054] In this embodiment, there are three first connection holes 111 and three second connection holes 121, and the three first connection holes 111 and the three second connection holes 121 are evenly distributed along the circumference of the stent body 110. Thus, the connector 130 can movably pass through the three first connection holes 111 and the three second connection holes 121, with a second connection hole 121 disposed between every two first connection holes 111. This ensures that the first connection holes 111 and the second connection holes 121 are staggered around the circumference of the stent body 110. This allows for stable and reliable release of the stent implant 100 at different stages during surgery, resulting in a simple structure and convenient operation during surgery.

[0055] It should be understood that the connection point 140 between the connector 130 and the positioning member 120 does not overlap with the connection point 150 between the connector 130 and the stent body 110. In the deployed state, all connection points 140 and 150 are arranged on the same circumference and are arranged sequentially along the circumference of the stent body 110. At this time, the circumferential spacing between the connection points 140 and 150 is not limited. As long as the connector 130 is tightened at this time, the stent body 110 and the positioning member 120 will not easily move axially. However, before deployment, the position of the connection point 140 between the connector 130 and the positioning member 120 is variable, and the position of the connection point 140 can be adaptively adjusted according to the position of the positioning member 120 to match the operation at different stages during the operation.

[0056] Referring to FIG. 7 , during delivery, stent implant 100 is in a compressed state, i.e., radially contracted and axially elongated. At this point, connector 130 is no longer continuously distributed along the circumference of stent body 110. Instead, a portion of connector 130 extends circumferentially, while another portion of connector 130 extends axially outside stent body 110. Furthermore, positioning member 120 is located forward of inflow end 110B of stent body 110, placing positioning member 120 outside the axial height range of stent body 110. This reduces the radial dimension (e.g., diameter) of stent implant 100 when compressed, eliminating the need to increase the size of delivery system 200, facilitating implantation and minimizing harm to the patient. In this way, the connecting member 130 can autonomously adjust its extension state according to the position of the positioning member 120. Correspondingly, the connection point 140 between the connecting member 130 and the positioning member 120 also moves with the change of the extension state of the connecting member 130, and the connection point 150 between the connecting member 130 and the bracket body 110 is always located at the first connection hole 111 of the bracket body 110.

[0057] Connector 130 is any linear structure with a certain strength and elasticity, such as an elastomer such as a wire, rope, string, or spring. Connector 130 is resistant to breakage and exhibits good elasticity. In practice, the elasticity requirements of connector 130 can be met through material elasticity and / or structural elasticity. In some embodiments, connector 130 is made of a commonly used medical polymer material, particularly a polymer material with excellent strength and elasticity. For example, in this embodiment, connector 130 can be made of expanded polytetrafluoroethylene or polyester. The material of the connector 130 can also be selected from thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone polyether polyurethane, silicone-polycarbonate polyurethane, and ultra-high molecular weight polyethylene, or other biocompatible polymers can also be used to prepare the connector 130, for example, optionally including polyolefins, elastomers, polyethylene glycol, polyether sulfone, polysulfone, polyvinyl pyrrolidone, polyvinyl chloride, other fluoropolymers, silicone polyesters, siloxane polymers and / or oligomers, and / or polylactones, and block copolymers thereof. In some embodiments, the connector 130 adopts an elastic structure, such as a wavy structure, a spiral coil structure, etc., which can better meet the expansion and contraction requirements. Optionally, the surface of the connector 130 is treated with anticoagulation so that the connector 130 has an anticoagulant function. After the anticoagulation treatment, the surface of the connector 130 contains an anticoagulant, which includes but is not limited to a heparinized polymer.

[0058] The structure of the positioning member 120 includes, but is not limited to, the frame structure shown in the figure. For example, a mesh structure or a sheet structure may also be used, as long as the positioning member 120 can be folded and unfolded and inserted into the bottom of the aortic sinus for anchoring. The positioning member 120 needs to include three positioning pins 120a, which are distributed along the circumference of the positioning member 120. Preferably, the three positioning pins 120a are evenly distributed along the circumference of the positioning member 120. The inflow ends 123 of the three positioning pins 120a are used to be inserted into the three sinuses of the aortic valve (left sinus, right sinus, and posterior sinus) for anchoring, ensuring that the artificial heart valve is stably and reliably fixed to the aortic valve.

[0059] As shown in Figure 5, in one embodiment, each positioning foot 120a is a rod structure, which is easy to open and fold, and is also easy to extend into the sinus of the aortic valve through the inflow end 123 for anchoring. However, the shape of the positioning foot 120a includes but is not limited to a V-shape, but any shape that can be extended into the bottom of the aortic sinus to achieve abutment, such as a quasi-V-shape, a U-shape, a quasi-U-shape, etc. The quasi-V-shape here should be understood as not being a standard V-shape in the strict sense, and the quasi-U-shape is not a standard U-shape in the strict sense. Although the positioning foot 120a of a rod structure is mentioned, it is not actually limited to this. Preferably, the inflow end 123 of each positioning foot 120a is a smooth structure to reduce damage to the aortic sinus.

[0060] The positioning member 120 can be an integrally formed structure or a split-formed structure. In this embodiment, each positioning foot 120a is a V-shaped rod structure, which can be cut and formed as a whole, and a second connecting hole 121 is provided on the connecting portion of each two adjacent positioning feet 120a. The material of the positioning member 120 is not limited. For example, it can be made of nickel-titanium alloy or other biocompatible materials with shape memory properties, or a polymer material that can be elastically or plastically deformed, such as a balloon-expandable material. The structure of the positioning member 120 is similar to that of the stent body 110, and both can be expanded and contracted. Preferably, the positioning member 120 is made of a metal material with good elasticity so that the positioning member 120 can self-expand.

[0061] As shown in Figures 1, 2, and 4, in one embodiment, the outflow end 110A of the stent body 110 is provided with a plurality of delivery connections 112, such as two to three delivery connections 112. The plurality of delivery connections 112 are distributed along the circumference of the stent body 110, preferably evenly distributed along the circumference. The delivery connections 112 are configured to detachably connect to the delivery system 200 to ensure that the relative position of the prosthetic heart valve and the delivery system 200 remains unchanged during loading, unloading, and in-vivo delivery of the prosthetic heart valve.

[0062] In this embodiment, the delivery connection part 112 is a hook, which is used to be detachably connected to the delivery system 200. Three hooks can be provided, specifically on the crest of the outflow end 110A of the stent body 110, which protrudes in the direction away from the inflow end 110B. Optionally, the hook is a "T"-shaped structure. Preferably, the position of the first connection hole 111 corresponds to the position of at least part of the delivery connection part 112, that is, the first connection hole 111 is provided on the delivery connection part 112. In this way, it is convenient to provide the first connection hole 111 on the stent body 110, and it can also ensure the stability of the stent implant 100 when it is released. Of course, in other embodiments, the first connection hole 111 may not be provided on the delivery connection part 112. In this embodiment, the first connection hole 111 is provided on the outside of the hook, so that the connector 130 can be routed around the stent body 110 from the outside.

[0063] Based on the same inventive concept, an embodiment of the present invention also provides an artificial heart valve, comprising a valve, a skirt, and a stent implant 100. The valve comprises three artificial leaflets (not shown), which are disposed within the inner cavity of the stent implant 100. One end of each artificial leaflet is directly or indirectly connected to the stent body 110, while the other end of the artificial leaflet is free. The valve is made of animal pericardium or other biocompatible polymer materials. In operation, the valve replaces the native leaflets to open and close the blood channel. The skirt covers the inner side of the stent implant 100, or the outer side of the stent implant 100, or both the inner and outer sides of the stent implant 100 are covered with the skirt. The skirt provides a sealing function, preventing paravalvular leakage and effectively ensuring a single blood channel from the inflow tract of the artificial heart valve to the outflow tract of the artificial heart valve. The skirt is made of pericardium or other biocompatible polymer materials, such as PET (polyethylene terephthalate) and PTFE (polytetrafluoroethylene).

[0064] Please refer to Figures 6 to 13 for the delivery process of the artificial heart valve according to an embodiment of the present invention. However, it should be understood that the delivery method of the artificial heart valve according to an embodiment of the present invention is not limited. Common delivery methods include transfemoral artery, transapical route, transjugular route, etc. The following description uses transfemoral artery delivery as an example.

[0065] First, it should be noted that an embodiment of the present invention further provides a delivery system 200, comprising a sheath 201 and a delivery guidewire 202. During delivery, the artificial heart valve is compressed and loaded into the sheath 201. The delivery guidewire 202 can be movably inserted into the sheath 201, and one end of the delivery guidewire 202 is detachably connected to the outflow end 110A of the stent body 110. The delivery guidewire 202 is used to push the artificial heart valve along the axial direction of the sheath 201, thereby controlling the delivery and release of the artificial heart valve.

[0066] As shown in Figures 6 and 7, the artificial heart valve of an embodiment of the present invention can be delivered to the aortic root (near the aortic valve) via the femoral artery using a delivery system 200. During delivery, the artificial heart valve is entirely compressed within the sheath 201. At this time, the stent body 110 contracts radially and stretches axially, causing the connector 130 to be partially distributed axially outside the stent body 110 and the connection point 140 to move beyond the inflow end 110B of the stent body 110, thereby folding and contracting the positioning member 120 in front of the inflow end 110B of the stent body 110. Furthermore, during the procedure, the position of the delivery system 200 can be adjusted in real time to ensure better centering and reduce damage to blood vessels and tissues.

[0067] Subsequently, as shown in Figures 8 to 10, the delivery system 200 can be rotated so that each positioning foot 120a (such as the inflow end 123) is aligned with the corresponding aortic sinus. After that, the sheath 201 is withdrawn to separate the artificial heart valve from the sheath 201. However, at this time, the stent body 110 is still connected to the delivery guide wire 202 and has not been unfolded. Only the positioning member 120 is unfolded after being separated from the constraint of the sheath 201. At the same time, the connecting member 130 moves with the unfolding of the positioning member 120. Then, under the pull of the connecting member 130, the positioning member 120 is also moved from its original position to the outside of the stent body 110 and arranged around the stent body 110, as shown in Figures 9 and 10.

[0068] Then, as shown in Figure 11, after releasing the positioning member 120, continue to manipulate the delivery guide wire 202 to deliver the artificial heart valve forward until the inflow end 123 of each positioning foot 120a of the positioning member 120 is inserted into the sinus of the aortic valve for positioning and anchoring, and at the same time confirm the position of the stent body 110 to ensure that the stent body 110 is located at the position of the native aortic valve.

[0069] After confirmation, as shown in Figures 12 and 13, the connection between the delivery guide wire 202 and the stent body 110 is released, thereby releasing the entire artificial heart valve, allowing the stent body 110 to expand radially, and the connecting piece 130 to be further tightened. Synchronously, the relative position of the stent body 110 and the positioning piece 120 is further tightened to a predetermined position. At this time, under the anchoring of the positioning piece 120 and the action of the tensioned connecting piece 130, the axial movement of the stent body 110 is firmly constrained, and the artificial heart valve is stably and firmly anchored in the aortic valve position, replacing the original diseased aortic valve to perform its function.

[0070] Refer to Figures 1 and 13 for further understanding. After the artificial heart valve is positioned and anchored, the inflow end 123 of each positioning foot 120a is inserted into a corresponding sinus of the aortic valve and abutted and anchored. At this time, the native leaflet is located between the positioning foot 120a and the stent body 110 (i.e., between the inner side of the positioning foot 120a and the outer side of the stent body 110). In this state, the connector 130 is relatively taut, and the entire connector 130 only surrounds and connects the positioning member 120 and the stent body 110 in the circumferential direction of the stent. It is not only relatively tightened with the stent body 110, but also relatively tightened with the positioning member 120. The relative positions of the three are maintained in a stable state. Thus, the axial movement of the stent body 110 is limited by the anchoring of the positioning member 120 and the tensioning of the connector 130. This positioning method can achieve aortic valve replacement for patients with pure aortic regurgitation who are difficult to anchor, and can ensure the reliability and stability of anchoring.

[0071] As shown in Figure 13, in actual use, according to the direction of blood flow, it can be understood that the artificial heart valve has an inflow end and an outflow end along its own axis. According to the normal flow direction of blood shown by the arrow, the outflow end is located downstream of the inflow end, and the direction from the inflow end to the outflow end can be limited to the axial direction of the stent implant 100.

[0072] In summary, compared with the prior art, the stent implant for an artificial heart valve and the artificial heart valve provided by the present invention have the following advantages:

[0073] (1) The stent implant provided by the present invention realizes the connection between the stent body, the positioning member and the connecting member through multiple first connecting holes and multiple second connecting holes, and thereby constrains the relative positions of the three, thereby enabling the movement trajectory and posture of the connecting member to be precisely controlled, while also ensuring the stability and rigidity of the connection, and ensuring the reliability and positioning accuracy of the stent implant.

[0074] (2) Since the connector is able to move relative to the positioning member and the stent body after being connected to the positioning member and the stent body, the connector can adaptively adjust its extension state based on the radial expansion and contraction movement of the stent implant, and thus the positioning member can adaptively adjust its position relative to the stent body. In this way, during the operation, the stent implant can adjust the relative position of the positioning member and the stent body without the need for additional control of the stent implant. Therefore, this delivery method does not require complex control operations, has a simple structure, high reliability, and accurate positioning.

[0075] (3) The provision of the positioning member also enables the stent implant to achieve aortic valve replacement for patients with pure reflux who are difficult to anchor. The positioning member can extend into the bottom of the aortic sinus, not only for initial positioning, but also to provide anchoring force, thereby achieving precise positioning of the artificial heart valve and stable and reliable anchoring of the artificial heart valve at the aortic valve.

[0076] (4) When the stent implant is in a compressed state, the positioning member is located in front of the inflow end of the stent body, so that the positioning member is arranged outside the axial height range of the stent body. In this way, the radial dimension of the stent implant is small when compressed, eliminating the need to increase the size of the delivery system 200, facilitating implantation and minimizing harm to the patient.

[0077] In general, the stent implant and the artificial heart valve containing the stent implant provided by the present invention can achieve reliable anchoring for patients with pure aortic valve regurgitation, and also have the advantages of simple structure, convenient intraoperative operation, accurate positioning, and high reliability. In addition, the radial dimension during the delivery process is small, which facilitates implantation and reduces harm to the patient.

[0078] It should be noted that those skilled in the art may make several improvements and additions without departing from the disclosure of the present invention, and such improvements and additions shall also be considered within the scope of protection of the present invention. Any equivalent changes, modifications, and evolutions made by those skilled in the art using the technical content disclosed above without departing from the spirit and scope of the present invention shall be considered equivalent embodiments of the present invention; at the same time, any equivalent changes, modifications, and evolutions made to the above embodiments based on the essential technology of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

1. A stent implant for an artificial heart valve, having an expanded state and a compressed state, characterized in that: It includes a stent body, a positioning member and a connecting member; the stent body is provided with at least three first connecting holes along its circumference; the positioning member is located on the outside of the stent body, and the positioning member is arranged around the stent body along the circumference of the stent body when unfolded; the positioning member is provided with at least three second connecting holes along the circumference of the stent body; one end of the connecting member can movably pass through all the first connecting holes and all the second connecting holes and then be connected to the other end; the connecting member can adaptively adjust the extension state based on the radial telescopic movement of the stent implant, so that the positioning member can adaptively adjust its position relative to the stent body.

2. The stent implant for an artificial heart valve according to claim 1, characterized in that: When the stent implant is in an expanded state, the connector extends continuously in the circumferential direction of the stent body, and the positioning member is arranged within the axial height range of the stent body; when the stent implant is in a compressed state during delivery, a portion of the connector extends in the circumferential direction of the stent body, and another portion of the connector extends axially outside the stent body, and the positioning member is located in front of the inflow end of the stent body and is arranged outside the axial height range of the stent body.

3. The stent implant for an artificial heart valve according to claim 1 or 2, characterized in that: All the first connection holes are arranged at the outflow end of the bracket body and arranged on the outside of the bracket body. All the first connection holes are distributed on the same circumferential surface and are evenly distributed.

4. The stent implant for an artificial heart valve according to claim 3, characterized in that: The outflow end of the stent body is provided with a plurality of delivery connection parts, and the position of the first connection hole corresponds to the position of at least part of the delivery connection parts.

5. The stent implant for an artificial heart valve according to claim 1 or 2, characterized in that: All the second connection holes are arranged at the outflow end of the positioning member, and all the second connection holes are distributed on the same circumferential surface and are evenly distributed.

6. The stent implant for an artificial heart valve according to claim 1 or 2, characterized in that: The number of the first connection holes and the number of the second connection holes are both three, and the three first connection holes and the three second connection holes are evenly distributed along the circumference of the bracket body.

7. The stent implant for an artificial heart valve according to claim 1 or 2, characterized in that: The positioning member includes three positioning feet, and the three positioning feet are distributed along the circumference of the bracket body. Each positioning foot is a rod structure and can be folded and unfolded.

8. The stent implant for an artificial heart valve according to claim 7, characterized in that: The inflow ends of the three positioning pins are used to be inserted into the three sinuses of the aortic valve one by one for anchoring.

9. The stent implant for an artificial heart valve according to claim 7, characterized in that: Each positioning foot is a V-shaped structure.

10. The stent implant for an artificial heart valve according to claim 1 or 2, characterized in that: The surface of the connecting piece is treated with anti-coagulation.

11. The stent implant for an artificial heart valve according to claim 7, characterized in that: The inflow end of each positioning foot is a smooth structure.

12. The stent implant for an artificial heart valve according to claim 4, characterized in that: The plurality of delivery connection parts are evenly distributed along the circumference of the stent body.

13. The stent implant for an artificial heart valve according to claim 4, characterized in that: The conveying connection part is a hanging ear, and the hanging ear is a "T"-shaped structure.

14. The stent implant for an artificial heart valve according to claim 13, characterized in that: The first connection hole is arranged on the outer side of the hanging ear.

15. An artificial heart valve, characterized in that: A stent implant for an artificial heart valve comprising any one of claims 1-14.

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