Valve stent and valve prosthesis

Abstract

The present invention provides a valve stent and valve prosthesis, relating to the field of medical device technology. The valve stent includes an inner stent, an outer stent, and at least one balloon structure. The inner stent is disposed within the outer stent; the inner stent includes an inner stent body; the outer stent includes a main body portion, and the main body portion has a grid structure; the balloon structure is connected to the main body portion, and the balloon structure is provided with at least one liquid inlet, which is connected to a liquid filling cavity within the balloon structure. Fluid can be injected into the liquid filling cavity through the liquid inlet. After the liquid filling cavity is filled, the balloon structure has a grid-like shape. The present invention solves the problem of paravalvular leakage caused by poor fit between valve replacement devices and the valve annulus in the prior art, and improves the stability and safety of the valve stent and valve prosthesis.

Description

Technical Field

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

[0002] When a person's heart valves fail to close properly, it can cause heart valve regurgitation, which is leakage through the heart valves. Tricuspid regurgitation is caused by malformation of the right ventricular papillary muscles and tricuspid annulus, which prevents the valve leaflets from fully coapting during ventricular contraction, resulting in regurgitation. Due to the risks of surgery, surgical repair of tricuspid regurgitation is generally recommended to be performed at the same time as left heart valve surgery. Surgical repair is not recommended for patients with isolated tricuspid regurgitation. Therefore, minimally invasive interventional treatment of tricuspid regurgitation has become a hope for the treatment of isolated tricuspid regurgitation.

[0003] Due to the irregular location of the tricuspid valve and the differences between the right atrium and right ventricle, it is difficult to directly use a single-layer valve stent for tricuspid valve replacement as the heart beats. Currently, a double-layer stent is commonly used. The outer layer conforms to the inner wall of the heart and withstands the deformation caused by heart contraction, while the inner layer inside the outer layer provides a stable working environment for the artificial valve leaflets.

[0004] Existing replacement valve stents adopt an integrated structure, which is divided into an inner stent and an outer stent by folding or cutting the mesh structure. During transportation, it can be compressed to a smaller diameter and can present a double-layer stent state after release. However, due to the irregular shape of the tricuspid valve annulus, there are 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, which will cause 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 then affect the sealing of the valve leaflet. Therefore, the existing valve stent cannot fundamentally avoid the occurrence of reflux. 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 paravalvular leakage caused by poor fit between the valve replacement device and the valve ring in the prior art, and to 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, comprising an inner stent, an outer stent and at least one balloon structure, wherein the inner stent is arranged in the outer stent; the inner stent comprises an inner stent body; the outer stent comprises a main body, and the main body is a grid structure; the balloon structure is connected to the main body, and the balloon structure is provided with at least one liquid inlet, which is connected to the 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 is in a grid shape.

[0007] Furthermore, the balloon structure includes a first coating and a second coating, and the liquid-filled cavity is formed between the first coating and the second coating; the first coating is connected to the outer wall of the outer bracket, and the second coating is connected to the inner wall of the outer bracket; or the first coating and the second coating are respectively connected to the outer wall of the outer bracket; or the first coating and the second coating are respectively connected to the inner wall of the outer bracket.

[0008] Furthermore, the outer bracket further includes a flange portion, which is axially connected to the main body portion, and the flange portion is gradually bent from bottom to top in a direction away from the axis of the main body portion.

[0009] Furthermore, a plurality of anchoring structures are provided on the outer circumference of the outer bracket, and each anchoring structure includes a hanging ear and a guide portion, one end of the hanging ear is connected to the main body portion, and the other end of the hanging ear is connected to the guide portion.

[0010] Furthermore, a convex structure is provided at one end of the hanging ear close to the guide portion, and the convex structure protrudes toward a side close to the outer bracket.

[0011] Furthermore, at least one limiting block is fixedly connected to the inner wall of the hanging ear, and the limiting block is arranged near the convex structure.

[0012] Furthermore, the outer bracket and the inner bracket are an integral structure; or the outer bracket and the inner bracket are spaced apart, and the outer bracket and the inner bracket are connected via a connecting piece.

[0013] Furthermore, the hardness of the outer bracket is smaller than the hardness of the inner bracket.

[0014] The present invention also provides a valve prosthesis, characterized in that it includes: 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 on the inner side of the inner stent body, and the valve skirt is arranged along the circumference of the inner stent body.

[0015] According to a valve stent and valve prosthesis provided by the present invention, the valve stent is provided with an inner stent and an outer stent, and presents a double-layer stent state after the valve prosthesis is released. The main body of the outer stent is a grid structure, and the balloon structure is connected to the main body. Therefore, the balloon structure also presents a grid structure after filling. The filled balloon structure can fill the gap between the valve ring and the main body to avoid paravalvular leakage, increase the anchoring property, and avoid 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 can adapt to valve rings of more sizes or shapes. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0017] Figure 1 A schematic diagram of the structure of the inner bracket and the outer bracket provided in an embodiment of the present invention;

[0018] Figure 2 1 is a schematic structural diagram of a valve stent provided by an embodiment of the present invention;

[0019] Figure 3 is a front view of a valve stent provided by an embodiment of the present invention;

[0020] Figure 4 This is a schematic structural diagram of the valve stent balloon structure provided by an embodiment of the present invention when it is not inflated;

[0021] Figure 5 1 is a schematic structural diagram of a valve stent balloon structure provided by an embodiment of the present invention when inflated;

[0022] Figure 6 Schematic diagram of the internal structure of the balloon structure provided by an embodiment of the present invention;

[0023] Figure 7 is a schematic diagram of a partial cross-sectional structure of a balloon structure provided by an embodiment of the present invention;

[0024] Figure 8 is a schematic cross-sectional view of the valve prosthesis balloon structure provided by an embodiment of the present invention when it is not inflated;

[0025] Figure 9 It is a schematic cross-sectional view of the valve prosthesis balloon structure provided by an embodiment of the present invention when inflated.

[0026] Description of reference numerals:

[0027] Liquid filling chamber-101; channel-102; liquid inlet-103;

[0028] Internal stent-11; valve leaflets-111; internal stent body-112; valve skirt-113;

[0029] External bracket 12; flange 121; main body 122; anchoring structure 123; mounting ear 1231; guide 1232; protrusion 1233;

[0030] Balloon structure-13; first covering-131; second covering-132;

[0031] Native leaflets - 21. DETAILED DESCRIPTION

[0032] In order to make the above-mentioned objects, features and advantages of the present invention more clearly understood, the following detailed description of the specific embodiments of the present invention is given in conjunction with the accompanying drawings. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0033] Example 1

[0034] This embodiment provides a valve stent, such as Figure 1 As shown, it includes an inner stent 11, an outer stent 12 and at least one balloon structure 13, combined with Figure 2 and Figure 4 The installation positions of the inner and outer stents 11 and 12 are clearly visible, indicating that the inner stent 11 is positioned within the outer stent 12. After release, the inner and outer stents 11 and 12 are coaxially nested between the right atrium and right ventricle. Furthermore, the outer stent 12 is less rigid than the inner stent 11, meaning it is relatively soft overall, allowing it to deform with the annulus or right ventricle structure. Thus, when the annulus or right ventricle expands, the outer stent 12 expands accordingly to achieve a seal. When right heart function recovers and contracts, the outer stent 12 shrinks synchronously with the annulus and right ventricle.

[0035] like Figure 1 and Figure 2 As shown, the outer stent 12 is provided with a main body portion 122 of a grid structure, which circumferentially includes at least one complete grid layer, and the balloon structure 13 is connected to the main body portion 122, and the balloon structure 13 is adapted to the grid structure shape of the main body portion 122; Figure 6 As shown, the balloon structure 13 is provided with at least one liquid inlet 103, through which fluid can be injected into the liquid filling cavity 101 of the balloon structure 13, so that the balloon structure 13 is filled and expanded to form a grid shape, which can be understood as a tofu-like convex structure. The expanded balloon structure 13 is filled in the grid structure, and the expanded state of the balloon structure 13 after filling is as shown. Figure 5 As shown. Figure 4 and Figure 5 By comparing the unfilled state and the filled state of the balloon structure 13 , it can be understood that the balloon structure 13 can fill the gap between the valve ring and the main body 122 to avoid paravalvular leakage, wherein the fluid is preferably physiological saline.

[0036] The expansion degree and expansion position of the balloon structure 13 in this embodiment can be adjusted, and can adapt to valve rings of various sizes. The balloon structure 13 is highly integrated with the main body 122, has better stability, and will not cause damage to the leaflets; most importantly, by filling the grid of the main body 122 with the balloon structure 13, paravalvular leakage can be avoided without the need for additional parts of the replacement device, and it is easy to compress and store in the delivery system during loading.

[0037] In this embodiment, the balloon structure 13 is provided with one, and the liquid inlet 103 is provided with one; Figure 7 As shown, the balloon structure 13 includes a first covering 131 and a second covering 132, and a liquid-filled cavity 101 is formed between the first covering 131 and the second covering 132. Figure 6 As shown, the grid structure of the balloon structure 13 includes multiple connection points, that is, the first coating 131 and the second coating 132 are bonded at the connection points, thereby forming multiple relatively independent grids, so that the balloon structure 13 has a grid-like structure; in addition, a channel 102 is provided between two adjacent grids, that is, the first coating 131 and the second coating 132 are not bonded at the channel 102, so that the multiple grids are connected, that is, the fluid is facilitated to enter the liquid filling cavity 101 through the channel 102 to fill the entire balloon structure 13.

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

[0039] In another preferred embodiment, the balloon structure 13 is provided with one, that is, the liquid filling cavity 101 is also provided with one, and a plurality of liquid inlets 103 are provided, each liquid inlet 103 is respectively connected to 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 with liquid through one, two, three or five liquid inlets 103 to separately control the expansion of different circumferential parts of the main body 122; its grid structure includes multiple connection points, the first coating 131 and the second coating 132 are bonded at the connection points, and a channel 102 is provided between two adjacent grids, and the first coating 131 and the second coating 132 are not bonded at the channel 102, and the channel 102 facilitates the entry of fluid to fill the entire liquid filling cavity 101 of the balloon structure 13.

[0040] In another preferred embodiment, if multiple balloon structures 13 are provided, multiple corresponding liquid filling chambers 101 are provided, at least two balloon structures 13 are not connected to each other, and multiple liquid inlets 103 are provided, each liquid inlet 103 being connected to the liquid filling chamber 101 of each balloon structure 13. The multiple balloon structures 13 are independent of each other, that is, before the balloon structure 13 is bonded to the main body 122, the balloon structures 13 are spliced together, and then each balloon structure 13 is bonded to the main body 122 in sequence. Each liquid inlet 103 corresponds to a liquid filling chamber 101, and the balloon structure 13 at a specified position is filled according to the actual situation of the valve annulus, thereby improving the adaptability of the valve prosthesis.

[0041] like Figure 1 and 2 As shown, the outer bracket 12 is further provided with a flange portion 121, which is axially connected to the main body portion 122 and can be connected by a connector or a coating, or the flange portion 121 and the main body portion 122 can also be designed as an integral structure.

[0042] When the external stent 12 is deployed in the heart, the main body 122 is arranged on the inner side of the native tricuspid valve, and the flange 121 is bent in an axial direction away from the main body 122 and extends into the atrium, that is, the flange 121 is arranged tilted.

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

[0044] In another preferred embodiment, the outer bracket 12 and the inner bracket 11 are spaced apart from each other, that is, the outer bracket 12 and the inner bracket 11 are separate structures, and the outer bracket 12 and the inner bracket 11 are connected by a connecting piece.

[0045] like Figure 3 and Figure 4 As shown, a plurality of anchoring structures 123 are evenly distributed on the outer circumference of the outer stent 12. The anchoring structure 123 includes a hanging ear 1231 and a guide portion 1232. One end of the hanging ear 1231 is connected to the main body 122, and the other end of the hanging ear 1231 is connected to each guide portion 1232. The guide portion 1232 is circular or elliptical to avoid damaging the leaflet. Figure 8 and 9 It can be seen that the ear 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 ear 1231 and the main body 122 of the external support 12.

[0046] like Figure 2As shown, the inner wall of the ear 1231 is also provided with a convex structure 1233, which is provided at one end of the ear 1231 close to the guide portion 1232. The convex structure 1233 is in close contact with the native leaflet 21, and the convex structure 1233 is used to retract and anchor the native leaflet 21; in this embodiment, the convex structure 1233 is raised from the inner wall of the ear 1231 in the direction close to the native leaflet 21, and the convex structure 1233 is an arc-shaped structure, which makes the ear 1231 fit more closely with the native leaflet 21 while avoiding damage to the native leaflet 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 convex blocks, etc. When there are multiple limit blocks, they are arranged at intervals between adjacent two limit blocks. The limit blocks can increase the friction between the ear 1231 and the native leaflet 21, and at the same time 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. It is located at the original heart valve position, such as the tricuspid valve and mitral valve; the outer stent 12 fits the heart valve ring and is expanded and sealed by 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 leakage. The anchoring structure 123 hooks the original heart tissue, such as the tendon tendon, to fix the position of the valve stent. The flange portion 121 is bent to fit the inner wall of the atrium to prevent the stent from shifting.

[0049] Example 2

[0050] This embodiment provides a valve prosthesis, combined with Figure 8 and Figure 9 As shown, the valve prosthesis includes the valve stent of Example 1 and the valve leaflets 111 and valve skirt 113 mounted thereon. Radially, from the inside to the outside of the inner stent 11, the valve leaflets 111, the valve skirt 113, and the inner stent body 112 are arranged in this order. The inner stent body 112 has a cylindrical, tubular, lattice structure. The valve leaflets 111 are arranged on the inner side of the inner stent body 112, and the valve skirt 113 is arranged circumferentially along the inner stent body 112.

[0051] Combine Figure 8 and Figure 9 It is clear 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 annulus and the main body 122, thereby solving the problem of paravalvular leakage caused by poor fit with the valve annulus 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 a quantity of at least three pieces, and at least one developing mark is provided on the valve leaflets 111; and 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 PET or PTFE sutures.

[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 location 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 the 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 the 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 chordae tendineae to gather 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 annulus 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. 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. Therefore, the balloon structure 13 also presents a grid structure after filling. 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 can adapt to valve rings of more sizes or shapes. The present invention is 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 scope of protection of the present invention should be based on the scope defined by the claims.

[0060] Finally, it should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article, or device comprising the element.

[0061] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0062] The above description of the disclosed embodiments is intended to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is intended to conform to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A valve stent, characterized in that: It comprises an inner stent (11), an outer stent (12) and at least one balloon structure (13), wherein the inner stent (11) is disposed within the outer stent (12); The inner support (11) includes an inner support body (112); The outer bracket (12) includes a main body (122), and the main body (122) is a grid structure; The balloon structure (13) is connected to the main body (122), and the balloon structure (13) is provided with at least one liquid inlet (103), the liquid inlet (103) is connected to the 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), and the balloon structure (13) is in a grid shape after the liquid filling cavity (101) is filled; the balloon structure (13) includes a first covering film (131) and a second covering film (132), and the liquid filling cavity (101) is formed between the first covering film (131) and the second covering film (132); The first coating (131) is connected to the outer side wall of the outer bracket (12), and the second coating (132) is connected to the inner side wall of the outer bracket (12); or the first coating (131) and the second coating (132) are respectively connected to the outer side wall of the outer bracket (12); or the first coating (131) and the second coating (132) are respectively connected to the inner side wall of the outer bracket (12).

2. The valve stent according to claim 1, characterized in that The outer bracket (12) further comprises a flange portion (121), the flange portion (121) being connected to the main body portion (122) along the axial direction, and the flange portion (121) being gradually bent from bottom to top in an axial direction away from the main body portion (122).

3. 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 bracket (12), each anchoring structure (123) comprising a hanging ear (1231) and a guide portion (1232), one end of the hanging ear (1231) being connected to the main body (122), and the other end of the hanging ear (1231) being connected to the guide portion (1232).

4. The valve stent according to claim 3, characterized in that: An end of the hanging ear (1231) close to the guide portion (1232) is further provided with a convex structure (1233), and the convex structure (1233) protrudes toward a side close to the outer bracket (12).

5. The valve stent according to claim 4, characterized in that: At least one limiting block is fixedly connected to the inner wall of the hanging ear (1231), and the limiting block is arranged near the convex structure (1233).

6. The valve stent according to claim 1, characterized in that The outer bracket (12) and the inner bracket (11) are an integrated structure; Or the outer bracket (12) and the inner bracket (11) are spaced apart, and the outer bracket (12) and the inner bracket (11) are connected via a connecting piece.

7. The valve stent according to claim 6, characterized in that: The hardness of the outer bracket (12) is smaller than the hardness of the inner bracket (11).

8. A valve prosthesis, characterized in that: include: The valve stent according to any one of claims 1 to 7, and the valve leaflets (111) and valve skirt (113) mounted on the valve stent, wherein the valve leaflets (111) are arranged on the inner side of the inner stent body (112), and the valve skirt (113) is arranged along the circumference of the inner stent body (112).

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