Valve stent and valve prosthesis

Abstract

The invention provides a valve stent and a valve prosthesis, and relates to the technical field of medical instruments.The valve stent comprises an inner stent, an outer stent and at least one balloon structure, and the inner stent is arranged in the outer stent; the inner bracket comprises an inner bracket main body; the outer stent comprises a main body part, and the main body part is of a grid structure; the balloon structure is connected to the main body part, the balloon structure is provided with at least one liquid inlet, the liquid inlet is communicated with a liquid filling cavity in the balloon structure, fluid can be injected into the liquid filling cavity through the liquid inlet, and the balloon structure is in a grid shape after the liquid filling cavity is filled. The valve replacement device solves the problem of perivalvular leakage caused by poor fitting degree of a valve replacement device and a valve ring in the prior art, and the stability and safety of a valve support and a valve prosthesis are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly, to a valve stent. Background Art

[0002] When the heart valve of the human body cannot close normally, it will cause heart valve regurgitation, that is, leakage through the heart valve; tricuspid regurgitation is caused by the shape lesions of the right ventricular papillary muscle and the tricuspid annulus, so that the leaflets cannot be completely engaged during ventricular contraction, resulting in regurgitation. Due to the risks of surgical operations, surgical repair of tricuspid regurgitation is generally recommended to be carried out simultaneously during left heart valve surgery, rather than isolated tricuspid regurgitation patients. Therefore, minimally invasive interventional treatment of tricuspid regurgitation has become the hope for the treatment of isolated tricuspid regurgitation.

[0003] Due to the irregular position of the tricuspid valve or the differences between the right atrium and the right ventricle, it is difficult to directly select a single-layer valve stent for tricuspid valve replacement under the condition of the beating of the heart. Currently, a double-layer stent is usually used. The outer stent is used to fit the inner wall of the heart and withstand the deformation generated by heart contraction, while the inner stent inside the outer stent provides a stable working environment for the artificial leaflets.

[0004] The existing valve stent for replacement adopts an integral structure. The braided net or the mesh structure is divided into two parts, an inner stent and an outer stent, by folding or cutting. During transportation, it can be compressed into a smaller diameter, and after release, it can present a double-layer stent state. However, due to the irregular shape of the tricuspid annulus, there will be many problems when this structure is used for the tricuspid valve: the flipped and folded part cannot fit well with the inner wall of the right atrium, resulting in paravalvular leakage; and when the large-diameter outer stent is subjected to the pressure of the valve annulus, it will affect the shape of the small-diameter inner stent and further affect the sealing of the leaflets. Therefore, the existing valve stent cannot fundamentally avoid the occurrence of regurgitation. Summary of the Invention

[0005] The purpose of the present invention is to provide a valve stent and a valve prosthesis to solve the problem of poor fitting between the valve replacement device and the valve annulus resulting in paravalvular leakage in the prior art, and improve the stability and safety of the valve stent and the valve prosthesis.

[0006] To solve the above problems, the present invention first provides a valve stent, including an inner stent, an outer stent and at least one balloon structure. The inner stent is arranged inside the outer stent; the inner stent includes an inner stent body; the outer stent includes a main body part, and the main body part is a mesh structure; the balloon structure is connected to the main body part, the balloon structure is provided with at least one liquid inlet, the liquid inlet is communicated with a liquid filling cavity inside the balloon structure, and fluid can be injected into the liquid filling cavity through the liquid inlet. After the liquid filling cavity is filled, the balloon structure presents a mesh shape.

[0007] Further, the balloon structure includes a first film and a second film, and a liquid filling cavity is formed between the first film and the second film; the first film is connected to the outer side wall of the outer stent, and the second film is connected to the inner side wall of the outer stent; or the first film and the second film are respectively connected to the outer side wall of the outer stent; or the first film and the second film are respectively connected to the inner side wall of the outer stent.

[0008] Further, the outer stent further includes a flange portion, the flange portion is axially connected to the main body portion, and the flange portion is bent gradually away from the axis of the main body portion from bottom to top.

[0009] Further, a plurality of anchoring structures are further provided on the outer circumference of the outer stent, and each anchoring structure includes a lug and a guiding portion. One end of the lug is connected to the main body portion, and the other end of the lug is connected to the guiding portion.

[0010] Further, a convex portion structure is further provided at one end of the lug close to the guiding portion, and the convex portion structure protrudes toward the side close to the outer stent.

[0011] Further, at least one limiting block is fixedly connected to the inner wall of the lug, and the limiting block is arranged close to the convex portion structure.

[0012] Further, the outer stent and the inner stent are of an integral structure; or the outer stent and the inner stent are arranged at intervals, and the outer stent and the inner stent are connected by a connecting member.

[0013] Further, the hardness of the outer stent is less than the hardness of the inner stent.

[0014] The present invention also provides a valve prosthesis, which is characterized by comprising: the valve stent described in the above technical solution, and valve leaflets and a valve skirt installed on the valve stent. The valve leaflets are arranged inside the main body of the inner stent, and the valve skirt is arranged circumferentially along the main body of the inner stent.

[0015] According to a valve stent and a valve prosthesis provided by the present invention, the valve stent is provided with an inner stent and an outer stent. After the valve prosthesis is released, it presents a double-layer stent state. The main body portion of the outer stent is a grid structure, and the balloon structure is connected to the main body portion. Therefore, the balloon structure also presents a grid structure after being filled. The gap between the valve annulus and the main body portion can be filled by the filled balloon structure, avoiding the phenomenon of paravalvular leakage, increasing the anchoring property and also avoiding damage to the valve leaflets. It not only has good stability and high safety, but also the expansion degree and expansion position of the balloon structure can be adjusted, and it can adapt to more sizes or shapes of valve annuli. Description of the Drawings

[0016] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the accompanying drawings required for the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only the embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other accompanying drawings can also be obtained according to the provided accompanying drawings.

[0017] Figure 1 Structural schematic diagram of the inner stent and the outer stent provided by the embodiment of the present invention;

[0018] Figure 2 Structural schematic diagram of the valve stent provided by the embodiment of the present invention;

[0019] Figure 3 Front view of the valve stent provided by the embodiment of the present invention;

[0020] Figure 4 Structural schematic diagram of the valve stent when the balloon structure is not inflated;

[0021] Figure 5 Structural schematic diagram of the valve stent when the balloon structure is inflated;

[0022] Figure 6 Internal structural schematic diagram of the balloon structure provided by the embodiment of the present invention;

[0023] Figure 7 Partial cross-sectional structural schematic diagram of the balloon structure provided by the embodiment of the present invention;

[0024] Figure 8 Cross-sectional structural schematic diagram of the valve prosthesis balloon structure when not inflated;

[0025] Figure 9 Cross-sectional structural schematic diagram of the valve prosthesis balloon structure when inflated.

[0026] Explanation of reference numerals:

[0027] Liquid filling cavity - 101; Channel - 102; Liquid inlet - 103;

[0028] Inner stent - 11; Valve leaf - 111; Inner stent main body - 112; Valve skirt - 113;

[0029] Outer stent - 12; Flange part - 121; Main body part - 122; Anchoring structure - 123; Hanging ear - 1231; Guide part - 1232; Convex part structure - 1233;

[0030] Balloon structure - 13; First film - 131; Second film - 132;

[0031] Native leaflet - 21. Detailed implementation mode

[0032] To make the above - mentioned objects, features, and advantages of the present invention more obvious and understandable, the following will describe in detail the specific embodiments of the present invention with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0033] Embodiment 1

[0034] This embodiment provides a valve stent. As Figure 1 shown, it includes an inner stent 11, an outer stent 12, and at least one balloon structure 13. Combining Figure 2 and Figure 4 can clearly show the installation positions of the inner stent 11 and the outer stent, that is, the inner stent 11 is arranged inside the outer stent 12. After release, the inner stent 11 and the outer stent 12 are coaxially nested between the right atrium and the right ventricle. In addition, the hardness of the outer stent 12 is less than that of the inner stent 11, that is, the outer stent 12 is relatively soft as a whole, so that it can deform with the structure of the valve annulus or the right ventricle. Thus, when the valve annulus or the right ventricle expands, the outer stent 12 expands accordingly to achieve sealing; when the right heart function recovers and contracts, the outer stent 12 can shrink synchronously with the valve annulus and the right ventricle.

[0035] As Figure 1 and Figure 2 shown, the outer stent 12 is provided with a main body part 122 with a grid structure, and its circumference includes at least one complete layer of grids. The balloon structure 13 is connected to the main body part 122, and the balloon structure 13 is adapted to the grid structure shape of the main body part 122; as Figure 6 shown, the balloon structure 13 is provided with at least one liquid inlet 103. Through the liquid inlet 103, fluid can be injected into the liquid - filled cavity 101 of the balloon structure 13, so that the balloon structure 13 fills and expands to be in a grid shape. It can be understood as a raised structure in the shape of a beancurd block. After the balloon structure 13 expands, it fills the grid structure. The expanded state of the balloon structure 13 after filling is as Figure 5 shown. Through Figure 4 and Figure 5 the comparison between the unfilled state and the filled state of the balloon structure 13 in, it can be understood that the balloon structure 13 can fill the gap between the valve annulus and the main body part 122, avoiding the phenomenon of paravalvular leakage. Among them, the fluid is preferably normal saline.

[0036] In this embodiment, the inflation degree and inflation position of the balloon structure 13 can be adjusted, which can adapt to valve annuli of various sizes. The combination degree of the balloon structure 13 and the main body 122 is high, and the stability is better, without damaging the valve leaflets. Most importantly, by filling the grid of the main body 122 with the balloon structure 13, the phenomenon of paravalvular leakage can be avoided without adding extra components to the replacement device, and it is convenient to be compressed and put into the delivery system during the loading process of the delivery system.

[0037] In this embodiment, there is one balloon structure 13 and one liquid inlet 103. As Figure 7 shown, the balloon structure 13 includes a first film 131 and a second film 132, and a liquid filling cavity 101 is formed between the first film 131 and the second film 132. Combining with what is shown in Figure 6 as shown, the grid structure of the balloon structure 13 includes a plurality of connection points, that is, the first film 131 and the second film 132 are bonded at the connection points, thus forming a plurality of relatively independent grids, so that the balloon structure 13 presents a grid-like structure. In addition, a channel 102 is provided between two adjacent grids, that is, the first film 131 and the second film 132 are not bonded at the channel 102, so that the plurality of grids are connected to each other, that is, through the channel 102, it is convenient for the fluid to enter the liquid filling cavity 101 to fill the entire balloon structure 13.

[0038] Regarding the installation positions of the first film 131 and the second film 132, in this embodiment, the first film 131 is connected to the outer side wall of the outer stent 12, and the second film 132 is connected to the inner side wall of the outer stent 12. In another preferred embodiment, the first film 131 and the second film 132 are respectively connected to the outer side wall of the outer stent 12, and a liquid filling cavity 101 is formed between the first film 131 and the second film 132. In another preferred embodiment, the first film 131 and the second film 132 are respectively connected to the inner side wall of the outer stent 12, and a liquid filling cavity 101 is formed between the first film 131 and the second film 132.

[0039] In another preferred embodiment, there is one balloon structure 13, that is, there is also one liquid filling cavity 101, and there are a plurality of liquid inlets 103. Each liquid inlet 103 is respectively communicated with the liquid filling cavity 101 of the balloon structure 13, and each liquid inlet 103 can be independently controlled. For example, the liquid filling cavity 101 is filled through one, two, three or five liquid inlets 103, etc., to separately control the inflation conditions of different circumferential parts of the main body 122. Its grid structure includes a plurality of connection points, the first film 131 and the second film 132 are bonded at the connection points, and a channel 102 is provided between two adjacent grids. The first film 131 and the second film 132 are not bonded at the channel 102, and this channel 102 is convenient for the fluid to enter to fill the liquid filling cavity 101 of the entire balloon structure 13.

[0040] In another preferred embodiment, there are multiple balloon structures 13 provided, and correspondingly multiple liquid - filling cavities 101 are provided. At least two balloon structures 13 are not in communication with each other. There are multiple liquid inlets 103, and each liquid inlet 103 is respectively communicated with the liquid - filling cavity 101 of each balloon structure 13. The multiple balloon structures 13 are independent of each other. That is, before the balloon structures 13 are bonded to the main body part 122, the balloon structures 13 are spliced together, and then the balloon structures 13 are successively bonded to the main body part 122. Each liquid inlet 103 corresponds to a liquid - filling cavity 101, and the balloon structure 13 at the specified position is filled according to the actual situation of the valve annulus, improving the adaptability of the valve prosthesis.

[0041] As Figure 1 and 2 shown, the outer stent 12 is further provided with a flange part 121. The flange part 121 is axially connected to the main body part 122, and can be connected by a connecting piece or by a film covering, or the flange part 121 and the main body part 122 can also be designed as an integral structure.

[0042] When the outer stent 12 is deployed in the heart, the main body part 122 is arranged inside the native tricuspid valve, and the flange part 121 bends and extends into the atrium in a direction away from the axis of the main body part 122, that is, the flange part 121 is inclined.

[0043] Preferably, the outer stent 12 and the inner stent 11 in this embodiment are preferably an integral structure.

[0044] In another preferred embodiment, the outer stent 12 and the inner stent 11 are arranged at intervals, that is, the outer stent 12 and the inner stent 11 are a split structure, and the outer stent 12 and the inner stent 11 are connected by a connecting piece.

[0045] As Figure 3 and Figure 4 shown, a plurality of anchoring structures 123 are evenly distributed circumferentially on the outer periphery of the outer stent 12. The anchoring structure 123 includes a lug 1231 and a guiding part 1232. One end of the lug 1231 is connected to the main body part 122, and the other end of the lug 1231 is connected to each guiding part 1232. The guiding part 1232 is circular or elliptical to avoid damaging the valve leaflets. Combining Figure 8 and 9 it can be known that the lug 1231 is used to gather or fold the native valve leaflets 21 of the heart, so that the native valve leaflets 21 are located between the lug 1231 and the main body part 122 of the outer stent 12.

[0046] As Figure 2As shown, the inner wall of the ear 1231 is also provided with a convex structure 1233, and the convex structure 1233 is arranged at one end of the ear 1231 close to the guide portion 1232. The convex structure 1233 is in close contact with the native leaflets 21, and the convex structure 1233 is used to gather and anchor the native leaflets 21; in the present embodiment, the convex structure 1233 is protruded from the inner wall of the ear 1231 in a direction close to the native leaflets 21, and the convex structure 1233 is an arc-shaped structure, which makes the ear 1231 fit the native leaflets 21 more closely while avoiding damage to the native leaflets 21.

[0047] Preferably, at least one limit block is fixedly connected to the inner wall of the ear 1231, which is not shown in the structural diagram. A person skilled in the art can fully understand through the description that the limit block is arranged near the convex structure 1233; specifically, one, two or three limit blocks can be provided, and the limit blocks are preferably circular protrusions or circular protrusions. When there are multiple limit blocks, they are arranged at intervals between two adjacent limit blocks. The limit blocks can increase the friction between the ear 1231 and the native leaflet 21, and at the same time can avoid the problem of the barb design of the ear 1231 in the prior art damaging the native leaflet 21.

[0048] The inner stent 11 of this embodiment is used to support the artificial valve leaflet to ensure that it can open and close normally, and is located at the original heart valve position, such as the tricuspid valve and the mitral valve; the outer stent 12 fits the heart valve ring and expands to seal the gap through the balloon structure 13. The balloon structure 13 is located in the gap between the valve ring and the outer stent 12. After being filled with liquid, it expands and can fill irregular gaps to prevent blood from leaking. The anchoring structure 123 hooks the original heart tissue, such as the tendon, to fix the position of the valve stent. The flange part 121 is bent to fit the inner wall of the atrium to prevent the stent from shifting.

[0049] Embodiment 2

[0050] This embodiment provides a valve prosthesis, combined with Figure 8 and Figure 9 As shown, the valve prosthesis includes the valve support in the first embodiment and the valve leaflets 111 and the valve skirt 113 installed thereon. The inner support 11 is radially arranged from the inside to the outside in sequence, the valve leaflets 111, the valve skirt 113 and the inner support body 112, the inner support body 112 is a cylindrical tube-shaped grid structure, the valve leaflets 111 are arranged on the inner side of the inner support body 112, and the valve skirt 113 is arranged along the circumference of the inner support body 112.

[0051] Combination Figure 8 and Figure 9 It can be clearly seen from the cross-sectional comparison of the balloon structure 13 before and after filling in the valve prosthesis that the balloon structure 13 can fill the gap between the valve ring and the main body 122, thereby solving the problem of paravalvular leakage caused by poor fit with the valve ring in the prior art.

[0052] The valve leaflets 111 are made of elastic materials, such as high molecular polymers and animal-derived tissues, wherein the animal-derived tissues are preferably bovine pericardium materials, with at least three pieces, and at least one developing mark is provided on the valve leaflets 111; the valve skirt 113 is a polymer material braid, preferably sutured with PET or PTFE material sutures; the inner support body 112 is a diamond grid structure or a multi-layer diamond grid structure, and is made of memory alloy by integral engraving and cutting, preferably nickel-titanium memory alloy; the valve leaflets 111, the valve skirt 113 and the inner support body 112 are connected by sutures of PET or PTFE.

[0053] In addition, the specific implementation method of the valve prosthesis is as follows:

[0054] The valve prosthesis is loaded into a delivery system and delivered to the position of the tricuspid valve or mitral valve of the heart through the delivery system; the inner stent 11 and the outer stent 12 are coaxially nested and arranged in a tricuspid valve repair ring between the right atrium and the right ventricle; or the inner stent 11 and the outer stent 12 are coaxially nested and arranged in a mitral valve repair ring between the left atrium and the left ventricle;

[0055] When in use, first release the ear 1231, so that the ear 1231 passes through the tendineal chordae to close or fold the native tricuspid valve or the native mitral valve;

[0056] The delivery system is operated to release the main body 122 to the repair ring, and then the flange 121 is released, so that the flange 121 fits with the structure of the right atrium or the structure of the left atrium;

[0057] The balloon structure 13 is inflated with liquid to expand, so that the balloon structure 13 fills the gap between the valve ring and the valve prosthesis.

[0058] The valve stent of the present invention is provided with an inner stent 11 and an outer stent 12, which presents a double-layer stent state after the valve prosthesis is released, and the main body 122 of the outer stent 12 is a grid structure, and the balloon structure 13 is connected to the main body 122, so that the balloon structure 13 also presents a grid structure after being filled, and the filled balloon structure 13 can fill the gap between the valve ring and the main body 122 to avoid paravalvular leakage, increase the anchoring property and avoid damage to the native leaflet 21. It not only has a simple structure, good stability and high safety, but also the expansion degree and expansion position of the balloon structure 13 can be adjusted, and it can adapt to valve rings of more sizes or shapes; the present invention can be applicable to valve replacement, not limited to tricuspid valve or mitral valve replacement.

[0059] Although the present invention is disclosed as above, the present invention is not limited thereto. Any person skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the scope defined by the claims.

[0060] Finally, it should also be noted that in this text, relational terms such as first and second 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. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or further includes elements inherent to such process, method, article or device. Without further limitation, an element defined by the statement "comprising an..." does not exclude the presence of additional identical elements in the process, method, article or device comprising the said element.

[0061] The various embodiments in this specification are described in a progressive manner. Each embodiment focuses on the differences from other embodiments. For the same or similar parts among the various embodiments, reference may be made to each other.

[0062] The above description of the disclosed embodiments enables those skilled in the art to implement or use the present invention. Various modifications to these embodiments will be obvious to those skilled in the art. The general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to these embodiments shown herein, but rather to the broadest scope consistent with the principles and novel features disclosed herein.

Claims

1. A valve stent, characterized in that, It includes an inner stent (11), an outer stent (12) and at least one balloon structure (13), and the inner stent (11) is arranged inside the outer stent (12); The inner stent (11) includes an inner stent body (112); The outer stent (12) includes a main body part (122), and the main body part (122) is a grid structure; The balloon structure (13) is connected to the main body part (122), the balloon structure (13) is provided with at least one liquid inlet (103), the liquid inlet (103) is communicated with a liquid filling cavity (101) inside the balloon structure (13), and fluid can be injected into the liquid filling cavity (101) through the liquid inlet (103). After the liquid filling cavity (101) is filled, the balloon structure (13) is in a grid shape.

2. The valve stent according to claim 1, characterized in that, The balloon structure (13) includes a first film (131) and a second film (132), and the liquid filling cavity (101) is formed between the first film (131) and the second film (132); The first film (131) is connected to the outer side wall of the outer stent (12), and the second film (132) is connected to the inner side wall of the outer stent (12); or the first film (131) and the second film (132) are respectively connected to the outer side wall of the outer stent (12); or the first film (131) and the second film (132) are respectively connected to the inner side wall of the outer stent (12).

3. The valve stent according to claim 1, characterized in that, The outer stent (12) further includes a flange part (121), the flange part (121) is axially connected to the main body part (122), and the flange part (121) is bent gradually away from the axis of the main body part (122) from bottom to top.

4. The valve stent according to claim 1, characterized in that, A plurality of anchoring structures (123) are further provided on the outer circumference of the outer stent (12), and each anchoring structure (123) includes a lug (1231) and a guiding part (1232). One end of the lug (1231) is connected to the main body part (122), and the other end of the lug (1231) is connected to the guiding part (1232).

5. The valve stent according to claim 4, characterized in that, A convex part structure (1233) is further provided at one end of the lug (1231) close to the guiding part (1232), and the convex part structure (1233) protrudes towards the side close to the outer stent (12).

6. The valve stent according to claim 5, wherein, At least one limiting block is fixedly connected to the inner wall of the lug (1231), and the limiting block is arranged close to the convex part structure (1233).

7. The valve stent according to claim 1, characterized in that, The outer stent (12) and the inner stent (11) are of an integral structure; Or the outer stent (12) and the inner stent (11) are arranged at intervals, and the outer stent (12) and the inner stent (11) are connected by a connecting piece.

8. The valve stent according to claim 7, characterized in that, The hardness of the outer stent (12) is less than the hardness of the inner stent (11).

9. A valve prosthesis, characterized in that, It includes: The valve stent according to any one of claims 1-8, and valve leaflets (111) and valve skirts (113) installed on the valve stent. The valve leaflets (111) are arranged inside the inner stent body (112), and the valve skirts (113) are arranged along the circumference of the inner stent body (112).

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