A cardiac implant prosthesis

Abstract

The utility model provides a cardiac implant prosthesis, including a valve prosthesis and a second stent, wherein the valve prosthesis includes a first stent and an artificial valve leaflet arranged in the first stent, the first stent includes a first matching portion; the second stent includes a second matching portion, and the second matching portion is used to be arranged relative to the first matching portion. The valve prosthesis replaces the native atrioventricular valve, the second stent is arranged at the ventricular outflow tract, the first matching portion and the second matching portion respectively abut against the opposite sides of the part of the native valve leaflet of the native atrioventricular valve that has failed, so that the first stent and the second stent can support each other by means of the failed native valve leaflet, realize the anchoring of the cardiac implant prosthesis in the heart, reduce the radial expansion force exerted by the valve prosthesis on the native valve ring of the native atrioventricular valve, reduce the damage to the native valve ring, and reduce the squeezing of the ventricular outflow tract, and the second stent also provides radial support force to the ventricular outflow tract to avoid stenosis of the ventricular outflow tract.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical instruments, and in particular relates to a heart implant prosthesis. Background Art

[0002] Heart valves are the gates of the heart's blood circulation. Once they are narrowed or incompletely closed, the heart will be underpowered or fail, resulting in chest tightness, shortness of breath, general edema, weakness, chest pain and other symptoms, which are a hidden danger that endangers the lives and quality of life of the elderly. With the aging of the population and the development of medical technology, valvular heart disease (VHD) has become the third largest cardiovascular disease, seriously endangering human health.

[0003] Valve replacement is one of the important means to treat heart valve disease. For atrioventricular valve replacement, the anchoring of the artificial heart valve prosthesis after implantation in the heart is a major problem. The reason is that the native valve ring of the atrioventricular valve is relatively soft and it is difficult to provide a large enough radial support force to achieve the anchoring of the artificial heart valve prosthesis. In the prior art, the anchoring methods of the artificial heart valve prosthesis of the atrioventricular valve mainly include the following:

[0004] ① Use the calcified native valve ring to provide anchoring force.

[0005] ② Barbs are provided on the artificial heart valve prosthesis, and while the artificial heart valve prosthesis is used to radially expand the native valve ring, the barbs are also inserted into the native valve ring or other native tissues to achieve anchoring.

[0006] ③ Set a tether on the artificial heart valve prosthesis and achieve anchoring by connecting the thin rope to the native tissue.

[0007] The above-mentioned anchoring methods all have certain shortcomings. For the first method, the patient's native valve ring is required to be severely calcified. However, in reality, only a small number of patients have severely calcified native valve rings, and most patients have non-calcified or slightly calcified valve rings, which are not enough to provide sufficient anchoring force. That is, the universality of this anchoring method is low. For the second method, the radial size of the artificial heart valve prosthesis is too large, and the extrusion force on the native valve ring is also large, which is easy to cause damage to the native valve ring. In addition, the size of the barb and the angle between it and the main body of the artificial heart valve prosthesis are strictly required. If the angle is not appropriate or the size of the barb is too small, the barb is difficult to penetrate the native tissue. In the case where the size of the barb is too small, even if the barb penetrates the native tissue, it is difficult to provide sufficient anchoring force; if the size of the barb is too large, the barb is easy to pierce the native tissue, causing unnecessary damage, and even causing serious complications. For the third method, its operation is complicated, and the doctor's operation requirements are high. It may also cause irreversible damage to the native tissue and may cause serious complications.

[0008] In addition, after replacing the native atrioventricular valve, the artificial heart valve prosthesis in the prior art will, on the one hand, squeeze the ventricular outflow tract, causing stenosis of the ventricular outflow tract; on the other hand, during the heart contraction period, the native valve leaflets cannot rotate toward the direction close to the axis of the atrioventricular valve ring due to the obstruction of the artificial heart valve prosthesis, but instead rotate toward the direction of the aortic valve under the impact of blood, causing obstruction to the ventricular outflow tract. These will cause ventricular outflow tract obstruction. Utility Model Content

[0009] The utility model aims to provide a cardiac implant prosthesis, aiming to change the anchoring mode of the valve prosthesis, and on the premise of improving the universality of the anchoring mode, also reduce the damage to the native tissue and avoid the occurrence of ventricular outflow tract obstruction.

[0010] To achieve the above-mentioned purpose, the utility model provides a cardiac implant prosthesis, including a valve prosthesis and a second stent; the valve prosthesis includes a first stent and an artificial valve leaflet arranged in the first stent, the first stent includes a first matching portion; the second stent includes a second matching portion, and the second matching portion is used to be arranged opposite to the first matching portion.

[0011] Optionally, the valve prosthesis is configured to be implanted in the atrium to replace the native atrioventricular valve, the second stent is configured to be implanted in the ventricular outflow tract corresponding to the replaced native atrioventricular valve, and the second mating portion and the first mating portion respectively abut against opposite sides of part of the native leaflets of the native atrioventricular valve.

[0012] Optionally, the cardiac implant prosthesis further includes a coupling member, which is disposed between the outflow end of the first stent and the inflow end of the second stent, and the coupling member connects the first matching portion and the second matching portion.

[0013] Optionally, a covering is provided on the second bracket.

[0014] Optionally, the first stent and the second stent are of split structure, and an anti-endothelialization drug coating is provided on the outer surface of the second stent; and / or a joint is formed on the inflow end or the outflow end of the second stent.

[0015] Optionally, the second bracket includes an opening, the opening extends along the axial direction of the second bracket, and the opening is at least partially opposite to the second matching portion in the circumferential direction of the second bracket.

[0016] Optionally, on a cross section perpendicular to the axial direction of the second bracket, a central angle formed by a line connecting two edge points of the opening in the circumferential direction of the second bracket and a center point of the second bracket is 10°-210°.

[0017] Optionally, one of the first matching portion and the second matching portion includes a recessed structure recessed in a direction close to the axis of the corresponding bracket, and the other includes a protruding structure protruding in a direction away from the axis of the corresponding bracket, and the protruding structure matches the recessed structure.

[0018] Optionally, the first matching portion includes a first concave-convex structure, which includes alternately arranged first concave portions and first convex portions; the second matching portion includes a second concave-convex structure, which includes alternately arranged second convex portions and second concave portions, the second convex portions are arranged correspondingly to the first concave portions and match each other, and the second concave portions are arranged correspondingly to the first convex portions and match each other.

[0019] Optionally, the cardiac implant prosthesis further comprises barbs, at least part of which are arranged on an outer surface of the first fitting portion.

[0020] Optionally, the cardiac implant prosthesis further comprises barbs, at least part of which are arranged on an outer surface of the second fitting portion.

[0021] Compared with the prior art, the cardiac implant prosthesis and artificial heart valve prosthesis of the utility model have the following advantages:

[0022] The aforementioned cardiac implant prosthesis comprises a valve prosthesis and a second stent, wherein the valve prosthesis comprises a first stent and an artificial valve leaflet arranged in the first stent, wherein the first stent comprises a first matching portion; and the second stent comprises a second matching portion, wherein the second matching portion is arranged opposite to the first matching portion. When the cardiac implant prosthesis is implanted in the heart, the valve prosthesis is used to replace the native atrioventricular valve, the second stent is arranged at the ventricular outflow tract, and the first mating portion and the second mating portion respectively abut on opposite sides of the failed native leaflets of the native atrioventricular valve (for example, the anterior leaflet of the mitral valve), so that the first stent and the second stent can support each other through the failed native leaflets, thereby achieving anchoring of the cardiac implant prosthesis in the heart, reducing the radial expansion force exerted by the valve prosthesis on the native valve ring of the native atrioventricular valve, reducing damage to the native valve ring, and reducing the squeezing of the ventricular outflow tract. At the same time, the presence of the second stent also provides radial support force to the ventricular outflow tract to avoid stenosis of the ventricular outflow tract, and the second mating portion and the first mating portion respectively abut on opposite sides of the failed native leaflets, thereby achieving the limitation of the native leaflets, thereby avoiding the native leaflets from rotating toward the direction of the aortic valve during the heart contraction period and blocking the ventricular outflow tract. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The accompanying drawings are used to better understand the present invention and do not constitute an improper limitation on the present invention.

[0024] Figure 1 This is a schematic structural diagram of a first bracket of a cardiac implant prosthesis provided by the utility model according to the first embodiment;

[0025] Figure 2 1 is a schematic structural diagram of a first stent of a cardiac implant prosthesis provided by the utility model according to the first embodiment. Figure 2 and Figure 1 The observation direction is different;

[0026] Figure 3 This is a schematic structural diagram of a second bracket of a cardiac implant prosthesis provided by the utility model according to the first embodiment;

[0027] Figure 4 1 is a schematic diagram of the structure of a second stent of a cardiac implant prosthesis provided by the utility model according to the first embodiment. Figure 4 The joint is shown in FIG.

[0028] Figure 5 1 is a schematic diagram of the structure of a second stent of a cardiac implant prosthesis provided by the utility model according to the first embodiment. Figure 5 and Figure 3 The observation direction is different;

[0029] Figure 6 This is a schematic diagram of an application scenario of a cardiac implant prosthesis provided by the utility model according to the first embodiment, wherein the arrows in the diagram indicate the direction of blood flow;

[0030] Figure 7 It is a partially enlarged schematic diagram of an application scenario of a cardiac implant prosthesis provided by the utility model according to the first embodiment;

[0031] Figure 8 1 is a partial structural schematic diagram of a first bracket of a cardiac implant prosthesis provided by the utility model according to the first embodiment, wherein the first matching portion in the figure includes a protruding structure;

[0032] Fig. 9 1 is a partial structural schematic diagram of a first bracket of a cardiac implant prosthesis provided by the utility model according to the first embodiment, wherein the first matching portion in the figure includes a concave structure;

[0033] Fig.10 1 is a partial structural schematic diagram of a first bracket of a cardiac implant prosthesis provided by the utility model according to the first embodiment, wherein the first matching portion in the figure includes a first concave-convex structure;

[0034] Fig.111 is a partial structural schematic diagram of a first bracket of a cardiac implant prosthesis provided by the utility model according to the first embodiment. The first matching portion in the figure includes a first concave-convex structure. Fig.11 The first concavoconvex structure in Fig.10 The first concavoconvex structure in is different;

[0035] Fig.12 This is a schematic structural diagram of a cardiac implant prosthesis provided by the utility model according to the second embodiment;

[0036] Fig.13 This is a schematic diagram of an application scenario of a cardiac implant prosthesis provided by the utility model according to the second embodiment, wherein the arrows in the diagram indicate the direction of blood flow;

[0037] Fig.14 It is a partially enlarged schematic diagram of an application scenario of the cardiac implant prosthesis provided by the second embodiment of the present invention.

[0038] [Description of reference numerals is as follows]:

[0039] 100-first bracket, 110-first matching part, 111-protruding structure, 112-recessed structure, 113-first recessed part, 114-first protruding part, 120-first barb, 101-first segment, 102-second segment, 200-second bracket, 210-second matching part, 211-second protruding part, 212-second recessed part, 220-opening, 230-second barb, 240-joining part, 300-joining piece, 11-native valve ring, 12-native valve leaflet. DETAILED DESCRIPTION

[0040] The following describes the implementation of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific implementations, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner, so the diagram only shows the components related to the present invention rather than drawing according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0041] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise of being possible to implement, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0042] As used in this specification, the singular forms "one", "an", and "the" include plural objects, and the plural form "a plurality" includes more than two objects, unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense that includes "and / or", unless the content clearly indicates otherwise, and the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected or indirectly connected through an intermediate medium, and it can be a connection between two elements or an interactive relationship between two elements. Relational terms such as the terms "first", "second", etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations, nor do they indicate or imply relative importance or implicitly indicate the number of technical features indicated. It should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0043] The utility model aims to provide a cardiac implant prosthesis, aiming to change the anchoring mode of the valve prosthesis in the heart and also alleviate the problem of ventricular outflow tract obstruction caused by the implantation of the valve prosthesis.

[0044] In order to make the purpose, advantages and features of the utility model clearer, the utility model is further described in detail below in conjunction with the accompanying drawings. It should be noted that the drawings are all in a very simplified form and are not in precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the utility model. The same or similar reference numerals in the drawings represent the same or similar components.

[0045] The cardiac implant prosthesis comprises a valve prosthesis (not shown) and a second stent 200 (such as Figures 3 to 5 The valve prosthesis comprises a first stent 100 (as shown in Figure 1 and Figure 2 The first stent 100 includes a first matching portion 110, and the second stent 200 includes a second matching portion 210, which is used to be arranged opposite to the first matching portion 110.

[0046] In actual use, the cardiac implant prosthesis is used to be implanted in the left heart or the right heart, and the valve prosthesis is used to replace the native atrioventricular valve, and the second stent 200 is used to be arranged in the corresponding ventricular outflow tract. For example, when the cardiac implant prosthesis is implanted in the left heart, the valve prosthesis is used to replace the native mitral valve, and the second stent 200 is used to be arranged in the left ventricular outflow tract; when the cardiac implant prosthesis is implanted in the right heart, the valve prosthesis is used to replace the native tricuspid valve, and the second stent 200 is used to be arranged in the right ventricular outflow tract.

[0047] Specifically, please refer to Figure 6 , Figure 7 , Fig.13 and Fig.14 The first stent 100 has a portion of its circumferential direction opposite to the first matching portion 110 for abutting against the native valve ring 11 of the native atrioventricular valve, and the second stent 200 has at least a portion of its circumferential direction opposite to the second matching portion 210 for abutting against the inner wall of the ventricular outflow tract, and the second matching portion 210 and the first matching portion 110 are respectively used to abut against opposite sides of the failed native leaflets 12 of the native atrioventricular valve. In this way, the first stent 100 and the second stent 200 can support each other through the failed native leaflets 12, thereby achieving anchoring of the cardiac implant prosthesis in the heart.

[0048] This anchoring method, on the one hand, allows the first stent 100 to have a smaller outer diameter, so that the radial expansion force exerted by the valve prosthesis on the native valve ring 11 is reduced, thereby reducing damage to the native valve ring 11, and also reducing the squeezing of the ventricular outflow tract, alleviating the problem of ventricular outflow tract narrowing due to squeezing; on the other hand, the second stent 200 supported in the ventricular outflow tract is used to resist the squeezing of the ventricular outflow tract by the valve prosthesis, maintain the flow area of ​​the ventricular outflow tract, and further alleviate the problem of ventricular outflow tract narrowing; on the other hand, the second matching part 210 is used to prevent the failed native valve leaflet 12 from rotating toward the aortic valve side due to the impact of blood flow during the heart's contraction period, thereby avoiding the problem of ventricular outflow tract obstruction caused by the native valve leaflet 12 blocking the ventricular outflow tract.

[0049] It should be noted that the embodiment of the utility model does not limit the specific arrangement of the artificial valve leaflets, as long as the cardiac implant prosthesis is implanted in the heart and the native atrioventricular valve is replaced by the valve prosthesis, the artificial valve leaflets can be opened unidirectionally to allow blood to flow from the inflow end to the outflow end of the first stent 100 at the valve prosthesis, and prevent blood from flowing from the outflow end to the inflow end of the first stent 100. The "inflow end of the first stent 100" is the end of the first stent 100 facing the atrium, and the "outflow end of the first stent 100" is the end of the first stent 100 away from the atrium, which is located in the ventricle.

[0050] It should be understood that when the heart valve prosthesis is implanted in the heart, at the valve prosthesis, the blood flow direction is parallel or substantially parallel to the axial direction of the first stent 100, and at the second stent 200, the blood flow direction is parallel or substantially parallel to the axial direction of the second stent 200. The circumferential direction of the first stent 100 refers to the direction surrounding the axis of the first stent 100, and the circumferential direction of the second stent 200 refers to the direction surrounding the axis of the second stent 200.

[0051] Next, the specific configuration of the cardiac implant prosthesis is introduced through specific embodiments.

[0052] <Example 1>

[0053] In this embodiment, please refer to Figure 6 and Figure 7 The first stent 100 and the second stent 200 are split structures and are not connected to each other, so as to allow the first stent 100 to be completely endothelialized and the valve prosthesis will not be displaced due to blood flow impact, and then the second stent 200 can be recovered to reduce foreign matter remaining in the heart.

[0054] Preferably, an anti-endothelialization drug coating is provided on the outer surface of the second stent 200 to prevent the second stent 200 from endothelialization and reduce the difficulty of recovering the second stent 200 .

[0055] It should be understood that the anti-endothelialization drug coating includes anti-endothelialization drugs, and optional drugs include but are not limited to one or more of rapamycin, paclitaxel or other drugs with similar functions.

[0056] The present invention does not specifically limit the specific recycling method of the second bracket 200. Figure 4 In an optional implementation, the second stent 200 further includes a joint 240, which is disposed on the inflow end or outflow end of the second stent 200 and is used to engage with a recovery device. It should be understood that "the inflow end of the second stent 200" refers to the end of the second stent 200 away from the aortic valve when the second stent 200 is implanted in the ventricular outflow tract, and the outflow end of the second stent 200 refers to the end of the second stent 200 close to the aortic valve when the second stent 200 is implanted in the ventricular outflow tract. That is, during cardiac systole, blood flows from the inflow end of the second stent 200 to the outflow end thereof. It can also be understood that when the cardiac implant prosthesis is implanted in the left heart, the aortic valve refers to the aortic valve, and when the cardiac implant prosthesis is implanted in the right heart, the aortic valve refers to the pulmonary valve.

[0057] The retrieval device includes a sheath tube and a plurality of traction parts, the sheath tube includes an inner sheath tube and an outer sheath tube, the inner sheath tube is movably disposed in the inner cavity of the inner sheath tube, the traction parts are partially and movably disposed in the inner cavity of the inner sheath tube, and the number of the traction parts matches the number of the engagement parts 240. When retrieving the second stent 200, the distal end of the sheath tube is sent into the body, and then the traction parts are manipulated so that the distal end of the traction parts extends from the distal end of the sheath tube, and the distal end of each traction part is engaged with one of the engagement parts 240. Then, the traction parts and the outer sheath tube are kept stationary, and the inner sheath tube is manipulated to move in the direction from the proximal end to the distal end, and a force is applied to the traction parts through the inner sheath tube, so that the radial contraction of the end of the second stent 200 close to the retrieval device is caused until the outer diameter of the end of the second stent 200 close to the retrieval device is reduced to be smaller than the inner diameter of the outer sheath tube. Then, the outer sheath is kept still, and the inner sheath and the traction part are manipulated to move from the distal end to the proximal end until the second stent 200 is pulled into the inner cavity of the outer sheath. Finally, the retrieval device and the second stent 200 are withdrawn from the body together.

[0058] It can be understood that if the joint 240 is arranged at the inflow end of the second stent 200, when the second stent 200 is recovered, the recovery device enters the heart from the apical approach. If the joint 240 is arranged at the outflow end of the second stent 200, when the second stent 200 is recovered, the recovery device enters the heart from the vascular approach. The embodiment of the utility model does not specifically limit the structure of the joint 240, as long as it can be engaged with the traction part. In an optional embodiment, the joint 240 may include a hook-like configuration, or may include a hole, and the hole may have any suitable shape, such as a circle, a prism, etc. In addition, those skilled in the art may use a medical device in the prior art that can perform the aforementioned recovery operation as the recovery device to achieve the recovery of the second stent 200, or may design a corresponding recovery device according to the aforementioned recovery operation. The specific structure of the recovery device is not an improvement of the utility model, so it is not described in more detail here.

[0059] Optionally, refer to Figure 3 and Figure 5 , the second stent 200 includes an opening 220. The opening 220 extends in the axial direction of the second stent 200, and the opening 220 is at least partially opposite to the second matching portion 210 in the circumferential direction of the second stent 200. When implanted in the heart, the portion of the second stent 200 adjacent to the opening 220 is used to abut against the inner wall of the ventricular outflow tract, and the opening 220 corresponds to the interventricular septum. In this way, the contact area between the second stent 200 and the myocardium is small, so as to reduce the stimulation to the myocardium and also avoid the occurrence of conduction bundle block.

[0060] The opening 220 may extend from the inflow end to the outflow end of the second bracket 200, so that the second bracket 200 is a C-shaped structure. Alternatively, when the joint is disposed at the inflow end of the second bracket, one end of the opening may extend to the outflow end of the second bracket, and the other end may be at a certain distance from the inflow end of the second bracket (not shown in the figure). When the joint is disposed at the outflow end of the second bracket, one end of the opening may extend to the inflow end of the second bracket, and the other end may be at a certain distance from the outflow end of the second bracket (not shown in the figure).

[0061] It should be noted that the opening 220 is at least partially opposite to the second matching portion 210 in the circumferential direction of the second bracket 200, including the situation that the line connecting the center point of the opening 220 and the center point of the second matching portion 210 intersects and is perpendicular to the axis of the second bracket 200, and also includes the situation that the line connecting the center point of the opening 220 and the center point of the second matching portion 210 intersects but is not perpendicular to the axis of the second bracket 200, and also includes the situation that the line connecting the center point of the opening 220 and the center point of the second matching portion 210 is not in the same plane as the axis of the second bracket 200.

[0062] In a cross section perpendicular to the axial direction of the second bracket 200, the opening 220 has two edge points opposite to each other in the circumferential direction of the second bracket 200, namely a first edge point M and a second edge point N (eg, Figure 5 As shown). On the same cross section, the line connecting the first edge point M and the center point S of the second bracket 200, and the line connecting the second edge point N and the center point S of the second bracket 200 form a central angle α. Usually, the central angle α is 10°-210°.

[0063] According to the actual anatomical characteristics of the human body, the axial dimension of the second stent 200 can be designed to be 10mm-35mm. And, in some implementations, the projection of the second stent 200 on a plane perpendicular to its axial direction is a part of a circle. Or, in other implementations, the projection of the second stent 200 on a plane perpendicular to its axial direction is a part of an ellipse, and, in this case, the size of the major axis of the ellipse is designed to be 15mm-35mm, and the size of the minor axis is designed to be 15mm-25mm. It can be understood that when the second stent 200 is implanted in the heart, the direction of blood flow in the second stent 200 is parallel or approximately parallel to the axial direction of the second stent 200, and the circumferential direction of the second stent 200 is the direction surrounding the axis of the second stent 200.

[0064] Optionally, refer to Figure 8The first matching portion 110 at least partially protrudes in a direction away from the axis of the first bracket 100 to form a protruding structure 111. Correspondingly, the second matching portion 210 at least partially recesses in a direction close to the axis of the second bracket 200 to form a recessed structure (not shown in the figure). The recessed structure cooperates with the protruding structure 111. During implantation, since the tissue of the native leaflet 12 is relatively soft, the raised structure 111 can squeeze the failed native leaflet 12 at least partially into the recessed structure, so that the shape of at least a portion of the failed native leaflet 12 matches and fits completely with the raised structure 111 and the recessed structure, thereby increasing the contact surface between the failed native leaflet 12 and the first stent 100 and the second stent 200, and thus increasing the interaction area between the first stent 100 and the second stent 200. Moreover, the raised structure 111 also generates squeezing force in all directions on the native leaflet 12, and then generates squeezing force in all directions on the recessed structure, thus further preventing the valve prosthesis from moving axially toward the atrium, and strengthening the anchoring performance of the cardiac implant prosthesis. The raised structure 111 can be as follows: Figure 8 Such arc-shaped protrusions may also be rectangular protrusions, triangular protrusions, or protrusions of any other suitable shapes.

[0065] In an alternative implementation, if Fig. 9 As shown, the first matching portion 110 is at least partially recessed toward the direction close to the axis of the first bracket 100 to form a recessed structure 112, and the second matching portion is at least partially protruded toward the direction away from the axis of the second bracket to form a protruding structure (not shown in the figure).

[0066] In an alternative implementation, see Fig.10 and Fig.11, the first matching portion 110 includes a first concave-convex structure, which includes a first concave portion 113 and a first convex portion 114 arranged alternately. And, the second matching portion 210 includes a second concave-convex structure, which includes a second convex portion 211 and a second concave portion 212 arranged alternately. The second convex portion 211 is arranged correspondingly to the first concave portion 113 and matches each other, and the second concave portion 212 is arranged correspondingly to the first convex portion 114 and matches each other. Each first convex portion 114 is used to squeeze part of the tissue of the failed native leaflet 12 into a corresponding second concave portion 212, and each second convex portion 211 is used to squeeze part of the tissue of the failed native leaflet 12 into a corresponding first concave portion 113. In other words, the first concave-convex structure cooperates with the second concave-convex structure and bites the failed native leaflet 12, while strengthening the interaction force between the first stent 100 and the second stent 200, and can further prevent the valve prosthesis from moving axially toward the atrium and shifting.

[0067] This embodiment does not particularly limit the specific forms of the first concave-convex structure and the second concave-convex structure. In an optional implementation, Fig.10 As shown, the first concave portion 113 is triangularly concave toward the direction close to the axis of the first bracket 100, and the first convex portion 114 is triangularly convex toward the direction away from the axis of the first bracket 100, so that the first concave-convex structure as a whole presents a triangular wave shape. In another optional implementation, as Fig.11 As shown, the first concave portion 113 is generally concave in an arc shape toward a direction close to the axis of the first bracket 100 , and the first convex portion 114 is generally convex in an arc shape toward a direction away from the axis of the first bracket 100 .

[0068] Alternatively, if Figure 1 As shown, the outer surface of the first matching portion 110 may also be provided with barbs, which are called first barbs 120. The first barbs 120 are used to penetrate the failed native valve leaflets 12 to improve the anchoring performance of the cardiac implant prosthesis and prevent the valve prosthesis from moving axially. In addition, the first barbs 120 are only provided on the first matching portion 120, while other parts of the first stent 100 are not provided with barbs, so as to avoid the first barbs 120 penetrating the native valve ring 11 or the ventricular wall and causing damage to the native valve ring 11, the ventricular wall, etc.

[0069] Similarly, if Figure 3 and Figure 5As shown, the outer surface of the second matching portion 210 may also be provided with barbs, which are called second barbs 230. The second barbs 230 are used to penetrate the failed native valve leaflets 12 to improve the anchoring performance of the cardiac implant prosthesis and prevent the valve prosthesis from moving axially. In addition, the second barbs 230 are only provided on the second matching portion 210, while the second barbs 230 are not provided on other parts of the second stent 200, so as to prevent the second barbs 230 from penetrating the ventricular wall and causing damage to the ventricular wall.

[0070] In this embodiment, the first stent 100 can be a woven stent or a cut stent. Similarly, the second stent 200 can be a woven stent or a cut stent. When the second stent 200 is a woven stent, the woven gap closest to the inflow end or the outflow end can be used as the joint 240, or the joint 240 can be additionally provided; when the second stent 200 is a cut stent, the pores cut closest to the inflow end or the outflow end can be used as the joint 240.

[0071] Furthermore, if Figure 1 As shown, the first stent 100 includes a first segment 101 and a second segment 102, and the first segment 101 and the second segment 102 are arranged and connected to each other along the direction from the inflow end to the outflow end of the first stent 100. The cross-section of the first segment 101 decreases in the direction close to the second segment 102, so that the first segment 101 is formed into a trumpet shape. The second segment 102 is used to pass through the native valve ring 11 and extend into the ventricle, and the first segment 101 is used to be placed in the atrium and laid on the native valve ring 11, so as to utilize the cooperation of the first segment 101 and the native valve ring 11 to prevent the valve prosthesis from moving toward the ventricle. It can be understood that the first cooperation portion 110 is arranged on the second segment 102.

[0072] In addition, when the cardiac implant prosthesis is implanted in the left heart and the valve prosthesis replaces the native mitral valve, Figure 2 As shown in FIG. 1 , the cross section of the second segment 102 may be D-shaped (or saddle-shaped) to match the shape of the native valve ring of the native mitral valve. Corresponding to the distance between the anterior leaflet and the posterior leaflet of the native mitral valve, the short axis AC of the cross section of the second segment 102 (eg, Figure 2 The size of the long axis IC (as shown) is 25mm-45mm, Figure 2The size of the short axis AC refers to the distance between the point corresponding to the anterior leaflet and the point corresponding to the posterior leaflet on the contour of the cross section of the second segment 102, and the size of the long axis IC refers to the distance between the two farthest points on the contour of the cross section of the second segment 102.

[0073] Other configurations of the valve prosthesis may refer to the heart valve prosthesis in the prior art, for example, a skirt is provided on the first stent (not shown in the figure), the skirt provides support for the endothelialization of the first stent, and also prevents paravalvular leakage between the first stent and the native valve ring. For another example, an inner layer stent is provided on the inner side of the first stent, the inner layer stent is connected to the first stent, and the artificial valve leaflet is connected to the inner layer stent, that is, the artificial valve leaflet is connected to the first stent through the inner layer stent (not shown in the figure), etc.

[0074] It should be understood that both the second stent 200 and the valve prosthesis have a crimping performance, so that the second stent 200 and the valve prosthesis can be crimped in corresponding delivery systems, respectively, and delivered using their respective delivery systems.

[0075] In practice, a two-way simultaneous approach is used to implant the cardiac implant prosthesis. Specifically, in one optional way, the second stent 200 is introduced through the femoral artery and released at the ventricular outflow tract, while the valve prosthesis is implanted through the femoral vein, or the valve prosthesis is implanted through the apical approach. In another optional way, when the supporting performance of the ventricular outflow tract is good, the second stent 200 is first introduced through the apical approach and released at the ventricular outflow tract, and then the delivery system of the second stent 200 is withdrawn, and then the valve prosthesis is implanted through the apical approach.

[0076] It can also be understood that in some implementations, the second stent 200 has a self-expanding property, and it automatically expands when it is delivered to the ventricular outflow tract by the corresponding delivery system and released. In other implementations, the second stent 200 does not have a self-expanding property, and it expands under the action of the balloon of the delivery system when it is delivered to the ventricular outflow tract by the corresponding delivery system and released. Similarly, in some implementations, the valve prosthesis has a self-expanding property, and it can automatically expand when it is delivered to the native valve annulus 11 by the corresponding delivery system and released. In other implementations, the valve prosthesis does not have a self-expanding property, and it expands under the action of the balloon of the delivery system when it is delivered to the native valve annulus 11 by the corresponding delivery system and released.

[0077] <Example 2>

[0078] Please refer to Figure 12 to Figure 14The difference between this embodiment and the first embodiment is that the first bracket 100 and the second bracket 200 are not separate structures, but are connected into one piece by a joint 300. The following only describes the difference between the cardiac implant prosthesis provided by this embodiment and the cardiac implant prosthesis provided by the first embodiment. For other parts not fully described, please refer to the first embodiment.

[0079] In this embodiment, the coupling member 300 is disposed between the outflow end of the first stent 100 and the inflow end of the second stent 200, and the coupling member 300 connects the first mating portion 110 and the second mating portion 220. When used, the coupling member 300 passes through the native tendineal chordae of the native atrioventricular valve, and abuts against the free end of the failed native leaflet 12 during the cardiac systole, and is subjected to the force from the native leaflet 12 in the direction from the atrium to the ventricle, thereby resisting the force from the ventricle to the atrium applied by the blood on the cardiac implant prosthesis, reducing the possibility of the valve prosthesis moving along its axial direction toward the atrium, and improving the anchoring stability of the cardiac valve implant prosthesis.

[0080] The joint 300 can have any suitable configuration. For example, the joint 300 is a flexible structure. In some possible implementations, the joint 300 includes multiple linear structures, such as 3-6. In other possible implementations, the joint 300 is a thin sheet structure. In some other possible implementations, the joint 300 is a grid structure. Based on anatomical characteristics, the length of the joint 300 can be designed to be 5mm-20mm. Here, the length of the joint 300 refers to the size of the part of the joint 300 between the outflow end of the first stent 100 and the inflow end of the second stent 200 when the joint 300 is straightened so that the first stent 100 and the second stent 200 are coaxial. For another example, the joint 300 is a rigid structure similar to a clip. Regardless of the configuration of the joint 300, it should not interfere with the release of the entire cardiac implant prosthesis in the heart while achieving the connection between the first stent 100 and the second stent 200.

[0081] It is understood that in this embodiment, the second stent 200 is not recovered after being implanted in the heart, so it is expected to be endothelialized as soon as possible. In view of this, a covering (not shown in the figure) is also provided on the second stent 200, and the provision of the covering is conducive to the rapid endothelialization of the second stent 200.

[0082] In this embodiment, the first bracket 100 can be a cutting bracket or a braided bracket; and the second bracket 200 can be a cutting bracket or a braided bracket. In some implementations, the first bracket 100, the second bracket 200 and the flexible connecting portion 300 can be separately formed and then connected into one piece in any suitable manner. In other implementations, the first bracket 100, the second bracket 200 and the flexible connecting portion 300 are directly formed as one piece, for example, by braiding a plurality of wires as one piece, or by cutting a tube as one piece.

[0083] During implantation, the cardiac implant prosthesis is delivered using the same delivery system. In one implementation, the cardiac implant prosthesis is accessed via the femoral vein, and the delivery system releases the cardiac implant prosthesis in the order of the second stent 200, the flexible connection portion 300, and the valve prosthesis. In another implementation, the cardiac implant prosthesis is accessed via the femoral artery, and after crossing the corresponding arterial valve (aortic valve or pulmonary valve), the cardiac implant prosthesis is released in the order of the valve prosthesis, the flexible connection portion 300, and the second stent 200.

[0084] In summary, the cardiac implant prosthesis provided by the embodiment of the utility model can be effectively and stably anchored in the heart, and also reduces the radial expansion force applied by the valve prosthesis on the native valve ring of the native atrioventricular valve, reduces damage to the native valve ring, and at the same time avoids stenosis of the ventricular outflow tract, and also avoids the native valve leaflets from rotating toward the direction of the aortic valve during heart contraction and causing obstruction to the ventricular outflow tract.

[0085] Although the utility model is disclosed as above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the utility model without departing from the spirit and scope of the utility model. Thus, if these modifications and variations of the utility model fall within the scope of the claims of the utility model and their equivalents, the utility model is also intended to include these modifications and variations.

Claims

1. A cardiac implant prosthesis, characterized in that: It comprises a valve prosthesis and a second stent; the valve prosthesis comprises a first stent and an artificial valve leaflet arranged in the first stent, the first stent comprises a first matching part; the second stent comprises a second matching part, and the second matching part is used to be arranged opposite to the first matching part.

2. The cardiac implant prosthesis according to claim 1, characterized in that: The valve prosthesis is configured to be implanted in the atrium to replace the native atrioventricular valve, the second stent is configured to be implanted in the ventricular outflow tract corresponding to the replaced native atrioventricular valve, and the second mating portion and the first mating portion respectively abut against opposite sides of part of the native leaflets of the native atrioventricular valve.

3. The cardiac implant prosthesis according to claim 1, characterized in that: The cardiac implant prosthesis further includes a coupling member, which is disposed between the outflow end of the first stent and the inflow end of the second stent, and connects the first matching portion and the second matching portion.

4. The cardiac implant prosthesis according to claim 3, characterized in that: The second bracket is provided with a covering.

5. The cardiac implant prosthesis according to claim 1, characterized in that: The first stent and the second stent are of split structure, and an anti-endothelialization drug coating is provided on the outer surface of the second stent; and / or a joint is formed on the inflow end or the outflow end of the second stent.

6. The cardiac implant prosthesis according to any one of claims 1 to 5, characterized in that: The second bracket includes an opening, the opening extends along the axial direction of the second bracket, and the opening is at least partially opposite to the second matching portion in the circumferential direction of the second bracket.

7. The cardiac implant prosthesis according to claim 6, characterized in that: On a cross section perpendicular to the axial direction of the second bracket, a central angle formed by a line connecting two edge points of the opening in the circumferential direction of the second bracket and a center point of the second bracket is 10°-210°.

8. The cardiac implant prosthesis according to any one of claims 1 to 5, characterized in that: One of the first matching portion and the second matching portion includes a recessed structure recessed in a direction close to the axis of the corresponding bracket, and the other includes a protruding structure protruding in a direction away from the axis of the corresponding bracket, and the protruding structure matches the recessed structure.

9. The cardiac implant prosthesis according to any one of claims 1 to 5, characterized in that: The first matching portion includes a first concave-convex structure, which includes alternately arranged first concave portions and first convex portions; the second matching portion includes a second concave-convex structure, which includes alternately arranged second convex portions and second concave portions, the second convex portions are arranged correspondingly to the first concave portions and match each other, and the second concave portions are arranged correspondingly to the first convex portions and match each other.

10. The cardiac implant prosthesis according to any one of claims 1 to 5, characterized in that: The cardiac implant prosthesis further includes barbs, at least part of which are disposed on an outer surface of the first fitting portion.

11. The cardiac implant prosthesis according to any one of claims 1 to 5, characterized in that: The cardiac implant prosthesis further includes barbs, at least part of which are disposed on an outer surface of the second fitting portion.

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