Disclosure of Invention
The invention aims to provide a valve support and a valve prosthesis, which are used for solving the problem of paravalvular leakage caused by poor fitting degree of a valve replacement device and an annulus in the prior art and improving the stability and safety of the valve support and the valve prosthesis.
In order to solve the problems, the invention firstly provides a valve support, which comprises an inner support, an outer support and at least one balloon structure, wherein the inner support is arranged in the outer support, the inner support comprises an inner support main body, the outer support comprises a main body part which 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 of a grid shape after the liquid filling cavity is filled.
Further, the saccule structure comprises a first tectorial membrane and a second tectorial membrane, wherein the liquid filling cavity is formed between the first tectorial membrane and the second tectorial membrane, the first tectorial membrane is connected to the outer side wall of the outer bracket, the second tectorial membrane is connected to the inner side wall of the outer bracket, or the first tectorial membrane and the second tectorial membrane are respectively connected to the outer side wall of the outer bracket, or the first tectorial membrane and the second tectorial membrane are respectively connected to the inner side wall of the outer bracket.
Further, the outer bracket further comprises a flange part, the flange part is axially connected with the main body part, and the flange part is gradually bent from bottom to top in the axial direction far away from the main body part.
Further, a plurality of anchoring structures are further arranged on the outer circumference of the outer support, each anchoring structure comprises a hanging lug and a guiding part, one end of each hanging lug is connected with the main body part, and the other end of each hanging lug is connected with the guiding part.
Further, a protruding portion structure is further arranged at one end, close to the guide portion, of the hanging lugs, and the protruding portion structure protrudes to one side, close to the outer support, of the hanging lugs.
Further, at least one limiting block is fixedly connected to the inner wall of the hanging lug, and the limiting block is arranged at a position close to the convex part structure.
Further, the outer support and the inner support are of an integral structure, or the outer support and the inner support are arranged at intervals, and the outer support is connected with the inner support through a connecting piece.
Further, the outer scaffold has a hardness less than the hardness of the inner scaffold.
The invention also provides a valve prosthesis, which is characterized by comprising the valve stent, valve leaflets and a valve skirt edge which are arranged on the valve stent in the technical scheme, wherein the valve leaflets She Sheyu are arranged on the inner side of the inner stent main body, and the valve skirt edge is circumferentially arranged along the inner stent main body.
According to the valve support and the valve prosthesis provided by the invention, the valve support is provided with the inner support and the outer support, the valve prosthesis is released to be in a double-layer support state, the main body part of the outer support is of a grid structure, and the balloon structure is connected to the main body part, so that the balloon structure also presents a grid structure after filling, gaps between the main body parts of the valve annulus can be filled through the filled balloon structure, the phenomenon of perivalvular leakage is avoided, the anchoring performance is improved, meanwhile, damage to valve leaflets can be avoided, the stability is good, the safety is high, and the expansion degree and the expansion position of the balloon structure can be adjusted, so that the valve prosthesis can adapt to valve annuluses with more sizes or forms.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
Example 1
The present embodiment provides a valve stent, as shown in fig. 1, including an inner stent 11, an outer stent 12 and at least one balloon structure 13, and the installation position of the inner stent 11 and the outer stent can be clarified by combining fig. 2 and fig. 4, that is, the inner stent 11 is disposed inside the outer stent 12, and after being released, the inner stent 11 and the outer stent 12 are disposed between the right atrium and the right ventricle in a coaxial nested manner. In addition, the hardness of the outer support 12 is smaller than that of the inner support 11, namely, the whole outer support 12 is relatively softer, so that the outer support 12 can deform along with the structure of an annulus or a right ventricle, when the annulus or the right ventricle expands, the outer support 12 expands along with the expansion to realize sealing, and when the right heart function recovers, the outer support 12 can synchronously shrink along with the annulus and the right ventricle.
As shown in fig. 1 and 2, the outer support 12 is provided with a main body 122 of a grid structure, the circumference of the main body 122 at least comprises a layer of complete grid, the balloon structure 13 is connected with the main body 122, the shape of the balloon structure 13 is matched with that of the grid structure of the main body 122, as shown in fig. 6, the balloon structure 13 is provided with at least one liquid inlet 103, fluid can be injected into a liquid filling cavity 101 of the balloon structure 13 through the liquid inlet 103, so that the balloon structure 13 is filled and expanded to form a grid shape, and can be understood to form a bean curd-shaped protruding structure, the expanded balloon structure 13 is filled in the grid structure, and the expanded state of the balloon structure 13 is shown in fig. 5. By comparing the unfilled and filled states of the balloon structure 13 in fig. 4 and 5, it can be understood that the balloon structure 13 can fill the gap between the annulus and the main body 122, avoiding the occurrence of perivalvular leakage, wherein the fluid is preferably physiological saline.
The expansion degree and the expansion position of the balloon structure 13 in the embodiment can be adjusted, the balloon structure 13 can be matched with annuloplasty rings of various sizes, the combination degree of the balloon structure 13 and the main body part 122 is high, the stability is better, the damage to the valve leaves is avoided, and most importantly, the balloon structure 13 is filled in the grid of the main body part 122, the phenomenon of paravalvular leakage can be avoided without additionally adding parts of a replacement device, and the balloon structure is convenient to compress in the loading process of a conveying system so as to be taken into the conveying system.
In this embodiment, the balloon structure 13 is provided with one balloon structure 13 and one liquid inlet 103, and as shown in fig. 7, the balloon structure 13 comprises a first coating 131 and a second coating 132, and a liquid filling cavity 101 is formed between the first coating 131 and the second coating 132. In combination with the lattice structure of the balloon structure 13 as shown in fig. 6, the lattice structure comprises a plurality of connection points, i.e. the first covering film 131 and the second covering film 132 are bonded at the connection points, so that a plurality of relatively independent lattices are formed, thereby enabling the balloon structure 13 to be in a lattice structure, and in addition, a channel 102 is arranged between two adjacent lattices, i.e. the first covering film 131 and the second covering film 132 are not bonded at the channel 102, so that a plurality of lattices are communicated, i.e. fluid can enter the liquid filling cavity 101 conveniently through the channel 102, so as to fill the whole balloon structure 13.
Regarding the mounting positions of the first cover 131 and the second cover 132, in the present embodiment, the first cover 131 is connected to the outer side wall of the outer bracket 12, and the second cover 132 is connected to the inner side wall of the outer bracket 12. In another preferred embodiment, the first and second cover 131, 132 are attached to the outer side wall of the outer stent 12, respectively, with the fluid-filled lumen 101 formed between the first and second cover 131, 132. In another preferred embodiment, the first and second membranes 131 and 132 are attached to the inner side wall of the outer stent 12, respectively, and the fluid-filled chamber 101 is formed between the first and second membranes 131 and 132.
In another preferred embodiment, the balloon structure 13 is provided with one, i.e. the liquid filling cavity 101 is also provided with one, the liquid inlet 103 is provided with a plurality of liquid inlets 103, each liquid inlet 103 is respectively communicated with the liquid filling cavity 101 of the balloon structure 13, each liquid inlet 103 can be independently controlled, for example, liquid filling is carried out on the liquid filling cavity 101 through one, two, three or five liquid inlets 103 so as to separately control the expansion condition of different circumferential parts of the main body part 122, the grid structure comprises a plurality of connection points, the first covering film 131 and the second covering film 132 are bonded at the connection points, a channel 102 is arranged between two adjacent grids, the first covering film 131 and the second covering film 132 are not bonded at the channel 102, and fluid can enter the liquid filling cavity 101 for filling the whole balloon structure 13 conveniently.
In another preferred embodiment, the balloon structures 13 are provided in plurality, so that the liquid filling cavities 101 are correspondingly provided in plurality, at least two balloon structures 13 are not communicated with each other, the liquid inlets 103 are provided in plurality, and each liquid inlet 103 is respectively communicated with the liquid filling cavity 101 of each balloon structure 13. When the balloon structures 13 are mutually independent, namely before the balloon structures 13 are bonded with the main body 122, the balloon structures 13 are spliced, then the balloon structures 13 are sequentially bonded with the main body 122, each liquid inlet 103 corresponds to a liquid filling cavity 101, the balloon structures 13 at the designated positions are filled according to the actual condition of the valve annulus, and the suitability of the valve prosthesis is improved.
As shown in fig. 1 and 2, the outer bracket 12 is further provided with a flange portion 121, and the flange portion 121 and the main body portion 122 are connected in the axial direction, and may be connected by a connector or by a coating, or the flange portion 121 and the main body portion 122 may be designed as an integral structure.
When the outer stent 12 is deployed in the heart, the main body 122 is disposed on the inner side of the native tricuspid valve, and the flange 121 is folded in a direction away from the axis of the main body 122 and extends into the atrium, i.e., the flange 121 is disposed obliquely.
Preferably, the outer bracket 12 and the inner bracket 11 in this embodiment are preferably of unitary construction.
In another preferred embodiment, the outer bracket 12 and the inner bracket 11 are arranged at intervals, i.e. the outer bracket 12 and the inner bracket 11 are in a split structure, and the outer bracket 12 and the inner bracket 11 are connected through a connecting piece.
As shown in fig. 3 and 4, the outer periphery Xiang Junyun of the outer support 12 is provided with a plurality of anchoring structures 123, the anchoring structures 123 include hanging lugs 1231 and guiding parts 1232, one end of each hanging lug 1231 is connected with the main body part 122, the other end of each hanging lug 1231 is connected with each guiding part 1232, each guiding part 1232 is circular or oval, damage to the valve leaflet is avoided, and as can be seen in fig. 8 and 9, the hanging lugs 1231 are used for folding or folding the native valve leaflet 21 of the heart, so that the native valve leaflet 21 is located between the hanging lugs 1231 and the main body part 122 of the outer support 12.
As shown in fig. 2, the inner wall of the hanging tab 1231 is further provided with a protruding portion structure 1233, the protruding portion structure 1233 is disposed at one end of the hanging tab 1231 close to the guiding portion 1232, the protruding portion structure 1233 is closely attached to the native valve leaflet 21, the protruding portion structure 1233 is used for gathering and anchoring the native valve leaflet 21, in this embodiment, the protruding portion structure 1233 is protruding from the inner wall of the hanging tab 1231 towards the direction close to the native valve leaflet 21, and the protruding portion structure 1233 is of an arc structure, so that the hanging tab 1231 is attached to the native valve leaflet 21 more and meanwhile damage to the native valve leaflet 21 can be avoided.
Preferably, at least one limiting block is fixedly connected to the inner wall of the hanging ring 1231, not shown in the structure diagram, and it can be fully understood by those skilled in the art through the description that the limiting block is disposed near the protruding portion structure 1233, specifically, one, two or three limiting blocks can be disposed, preferably, circular protruding points or circular protruding blocks are disposed on the limiting block, when a plurality of limiting blocks are disposed, two adjacent limiting blocks are disposed at intervals, the limiting block can increase the friction force between the hanging ring 1231 and the native valve leaflet 21, and meanwhile, the problem that the barb design of the hanging ring 1231 damages the native valve leaflet 21 in the prior art can be avoided.
The inner support 11 of this embodiment is used for supporting artificial valve leaflets, ensuring normal opening and closing, and is positioned at the original heart valve position, such as tricuspid valve and mitral valve, the outer support 12 is attached to the heart valve annulus, and the gap is sealed by the expansion of the balloon structure 13. The balloon structure 13 is positioned at the gap between the annulus and the outer stent 12, and is inflated after being filled with liquid, so that irregular gaps can be filled, and leakage of blood is prevented. The anchoring structures 123 hook over native heart tissue, such as chordae tendineae, thereby securing the valve stent position. The flange 121 is folded to fit the inner wall of the atrium, and serves to prevent displacement of the stent.
Example two
This embodiment provides a valve prosthesis, as shown in connection with fig. 8 and 9, comprising the valve stent of embodiment one and valve leaflets 111 and valve skirts 113 mounted thereon. The inner stent 11 comprises valve leaflets 111, a valve skirt 113 and an inner stent main body 112 in sequence from inside to outside along the radial direction, the inner stent main body 112 is of a cylindrical tubular grid structure, the valve leaflets 111 are arranged on the inner side of the inner stent main body 112, and the valve skirt 113 is circumferentially arranged along the inner stent main body 112.
As can be seen from fig. 8 and 9, the cross-section of the balloon structure 13 in the valve prosthesis before and after filling is compared, so that the balloon structure 13 can fill the gap between the valve annulus and the main body 122, thereby solving the problem of perivalvular leakage caused by poor fitting degree between the prior art and the valve annulus.
The valve leaflet 111 is made of elastic materials, such as high molecular polymers and animal-derived tissues, wherein the animal-derived tissues are preferably bovine pericardium materials, the number of the animal-derived tissues is at least three, at least one developing mark is further arranged on the valve leaflet 111, the valve skirt 113 is a polymer material woven body and is preferably formed by sewing a PET or PTFE suture, the inner support body 112 is of a diamond grid structure or a multi-layer diamond grid structure and is manufactured by integrally carving and cutting a memory alloy, preferably nickel-titanium memory alloy, and the valve leaflet 111, the valve skirt 113 and the inner support body 112 are connected by sewing PET or PTFE suture.
In addition, the valve prosthesis is embodied as follows:
the valve prosthesis is loaded in a delivery system and delivered to the position of the tricuspid valve or the mitral valve of the heart through the delivery system, the inner support 11 and the outer support 12 are coaxially nested in the tricuspid valve repair ring between the right atrium and the right ventricle, or the inner support 11 and the outer support 12 are coaxially nested in the mitral valve repair ring between the left atrium and the left ventricle;
when in use, the hanging lugs 1231 are released firstly, so that the hanging lugs 1231 penetrate through chordae tendineae to fold or fold the primary tricuspid valve or the primary mitral valve;
The delivery system is operated to release the main body part 122 to the repair ring, and then the flange part 121 is released, so that the flange part 121 is attached to the structure of the right atrium or the structure of the left atrium;
the balloon structure 13 is filled with liquid to expand, causing the balloon structure 13 to fill the gap between the annulus and the valve prosthesis.
The valve support is provided with the inner support 11 and the outer support 12, the valve prosthesis is released to be in a double-layer support state, the main body part 122 of the outer support 12 is of a grid structure, the balloon structure 13 is connected to the main body part 122, therefore, the balloon structure 13 also presents a grid structure after filling, gaps between the main body parts 122 of the valve annulus can be filled through the filled balloon structure 13, the phenomenon of perivalvular leakage is avoided, the anchoring performance is improved, meanwhile, the damage to the primary valve 21 can be avoided, the structure is simple, the stability is good, the safety is high, the expansion degree and the expansion position of the balloon structure 13 can be adjusted, and valve annuluses with more sizes or forms can be adapted.
Although the present invention is disclosed above, the present invention is not limited thereto. Various changes and modifications may be made by one skilled in the art without departing from the spirit and scope of the invention, and the scope of the invention should be assessed accordingly to that of the appended claims.
Finally, it is further noted that relational terms such as first and second, and the like are used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Moreover, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one does not exclude the presence of other like elements in a process, method, article, or apparatus that comprises an element.
In the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.