Valve prosthesis

Abstract

The valve prosthesis comprises an inner-layer support, an outer-layer support and an elastic piece, the inner-layer support is arranged in the outer-layer support in a penetrating mode and connected with the outer-layer support, and the two ends of the elastic piece are connected with the outer-layer support and the inner-layer support respectively. The inflow end of the inner-layer stent is connected with the outflow end of the outer-layer stent, and the inner wall of the outer-layer stent and the outer wall of the inner-layer stent are arranged at intervals, so that a certain deformation space is formed between the outer-layer stent and the inner-layer stent, and therefore, when the outer-layer stent is extruded to deform, the outer-layer stent can deform in the deformation space; and the probability that the outer-layer stent extrudes the inner-layer stent to influence the valve leaflet assembly is reduced.

Description

Technical Field

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

[0002] This section merely provides background information related to the present disclosure and is not necessarily prior art.

[0003] Heart valve disease can cause hemodynamic changes and easily lead to lesions in organs such as the heart and blood vessels. Currently, the most effective way to treat valvular disease is to replace the body's own valves with valve prostheses. The valve prostheses in the prior art all have a certain elastic deformation ability to adapt to the relaxation and expansion of the heart. However, when the valve prosthesis follows the beating of the heart, the valve leaflets in the valve prosthesis are easily deformed by excessive squeezing. Summary of the invention

[0004] Based on this, it is necessary to provide a valve prosthesis, including an inner layer stent, an outer layer stent and an elastic member, wherein the inner layer stent is inserted into the outer layer stent, the inner layer stent and the outer layer stent are connected, the inner layer stent and the outer layer stent are spaced apart, and the two ends of the elastic member are respectively connected to the outer layer stent and the inner layer stent.

[0005] Optionally, one end of the elastic member is connected to the inflow section or the middle section of the outer layer support, and the other end of the elastic member is connected to the outflow section of the inner layer support.

[0006] Optionally, the outflow section of the inner layer support is at least partially bent radially outward to form a flared structure, and the elastic member is connected to the flared structure.

[0007] Optionally, the elastic member includes a fitting portion, and the fitting portion at least partially fits with the outer layer support when the elastic member is deformed.

[0008] Optionally, the fitting portion is an arc-shaped structure, the convex surface of the arc-shaped structure is arranged toward the inflow end, and the concave surface of the arc-shaped structure is arranged toward the inflow end.

[0009] Optionally, the elastic member includes a first rod and a second rod connected to each other, the first rod and the second rod are arranged at a predetermined angle, one end of the first rod is connected to the outer layer support, the other end of the second rod is connected to the inner layer support, and the first rod forms the fitting portion.

[0010] Optionally, the valve prosthesis also includes a first coating, a second coating and a third coating, the first coating covers the outer wall of the outer layer stent, the second coating covers the inner wall of the inner layer stent, the first coating and the second coating are connected at the outflow end of the inner layer stent, the third coating is located between the inner layer stent and the outer layer stent and is respectively connected to the first coating and the third coating, and the third coating is located on the side of the elastic member close to the outflow end.

[0011] Optionally, there are multiple elastic members, all of which are arranged around the inner layer support, and the third coating covers all of the elastic members.

[0012] Optionally, the region between the outer layer support and the inner layer support includes a first region and a second region that are circumferentially adjacent to each other, and the distribution density of the elastic members in the first region is greater than that in the second region.

[0013] Optionally, the outer layer support includes a plurality of rhombus-shaped skeletons arranged along the circumferential direction, two adjacent rhombus-shaped skeletons are arranged at intervals, and the elastic member is connected to the rhombus-shaped skeletons.

[0014] Compared with the prior art, the beneficial effects of the valve prosthesis of the present invention are:

[0015] The present invention connects the inflow end of the inner layer support with the outflow end of the outer layer support, and the inner wall of the outer layer support and the outer wall of the inner layer support are arranged at intervals, so that there is a certain deformation space between the outer layer support and the inner layer support, so that when the outer layer support is squeezed and deformed, the outer layer support can be deformed in the deformation space, reducing the probability of the outer layer support squeezing the inner layer support and affecting the leaflet assembly. When the outer layer support is compressed and deformed, one end of the elastic member is connected to the outer layer support, and the other end of the elastic member is connected to the inner layer support, so that the deformation force on the outer layer support can be partially offset by the elastic deformation of the elastic member, thereby reducing the stress concentration at the connection node of the outer layer support and the inner layer support at the outflow end, and avoiding the outer layer support and the inner layer support from breaking at the connection point. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0017] Figure 1 is a schematic structural diagram of a valve prosthesis in Embodiment 1 of the present invention;

[0018] Figure 2 is a top view of the valve prosthesis in the first embodiment of the present invention;

[0019] Figure 3 is a schematic axial cross-sectional view of a valve prosthesis in Embodiment 1 of the present invention;

[0020] Figure 4 This is a schematic axial cross-sectional view of the valve prosthesis in Embodiment 1 of the present invention after the valve component is removed;

[0021] Figure 5 It is a structural schematic diagram of another implementation mode of the elastic member and the outer support in the first embodiment of the present invention;

[0022] Figure 6 For the present invention Figure 4 A structural enlarged schematic diagram of an implementation method of the structure at A in FIG.

[0023] Figure 7 For the present invention Figure 4 A schematic diagram of an enlarged structure of another embodiment of the structure at A;

[0024] Figure 8 This is a schematic diagram of the structure in which the outer frame of the outer support in the first embodiment of the present invention is arranged at intervals;

[0025] Fig. 9 This is a schematic diagram of the connection structure of the inner layer skeleton of the inner layer support in the first embodiment of the present invention;

[0026] Fig.10 Schematic diagram of the connection structure of the coating in the second embodiment of the present invention;

[0027] Fig.11 Schematic diagram of the distribution of elastic members in the first area and the second area in the second embodiment of the present invention.

[0028] Reference numerals:

[0029] 100-valve prosthesis; 110-inner stent; 111-first inflow section; 112-first middle section; 113-first outflow section; 114-first inner skeleton unit; 115-second inner skeleton unit; 120-outer stent; 121-second inflow section; 122-second middle section; 123-second outflow section; 124-first outer skeleton unit; 1241-first rod; 1242-second rod; 1243-third rod; 1244-fourth rod; 125 -second external skeleton unit; 1251-fifth rod; 1252-sixth rod; 1253-seventh rod; 1254-eighth rod; 130-elastic member; 131-fitting portion; 1311-convex surface; 1312-concave surface; 132-first rod; 133-second rod; 141-inflow end; 142-outflow end; 150-leaflet assembly; 161-first covering membrane; 162-second covering membrane; 163-third covering membrane; 171-first region; 172-second region. DETAILED DESCRIPTION

[0030] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present invention, so the present invention is not limited by the specific implementation disclosed below.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0032] In the field of interventional medical devices, the "distal end" is usually defined as the end away from the operator during surgery, and the "proximal end" is defined as the end close to the operator during surgery. In the present invention, the valve prosthesis includes an open state and a closed state. When the valve prosthesis is in the open state, blood can flow through the valve prosthesis, and when the valve prosthesis is in the closed state, blood cannot flow through the valve prosthesis. In the present invention, when the valve prosthesis is in a circulation state, the end where blood flows in is defined as the inflow end, and the end where blood flows out is defined as the outflow end.

[0033] Embodiment 1

[0034] This embodiment provides a valve prosthesis 100, which can be used to replace human valves, such as aortic valve, pulmonary valve, tricuspid valve, etc. In order to facilitate the description of the working principle of the valve prosthesis in this application, this embodiment takes the mitral valve as an example to illustrate the valve prosthesis in the present invention.

[0035] like Figure 1 As shown, the valve prosthesis 100 includes an inner layer stent 110, an outer layer stent 120 and an elastic member 130. The inner layer stent 110 is inserted into the outer layer stent 120, the outflow end of the inner layer stent 110 is connected to the outflow end of the outer layer stent 120, and the inner wall of the outer layer stent 120 is spaced apart from the outer wall of the inner layer stent 110 (except for the connection).

[0036] The inner stent 110 is a tubular structure, and the inner stent 110 can be made of shape memory metal material, medical stainless steel or polymer material. The inner stent 110 has a certain elastic deformation performance. When the inner stent 110 is squeezed, the inner stent 110 produces elastic deformation to adapt to the squeezing force. The inner stent 110 is used to provide a connection position for the leaflet assembly 150. The leaflet assembly 150 is sutured and connected to the inner stent 110. The leaflet assembly 150 is located on the inner side of the inner stent 110. The leaflet assembly 150 includes an open state and a closed state. When the leaflet assembly 150 is in the open state, blood can pass through the inner side of the inner stent 110. When the leaflet assembly 150 is in the closed state, the leaflet assembly 150 forms a blockage in the inner stent 110, and it is difficult for blood to pass through the inner side of the inner stent 110. In this example, when the valve assembly of the valve prosthesis 100 is in an open state, the end through which blood flows in is the inflow end 141 , and the end through which blood flows out is the outflow end 142 .

[0037] like Figure 2 As shown, the outer stent 120 is located radially outward of the inner stent 110, and the inner stent 110 is inserted into the outer stent 120. The inner wall of the outer stent 120 and the outer wall of the inner stent 110 are spaced apart except for the connection part, and the inner wall of the outer stent 120 and the outer wall of the inner stent 110 have a certain spacing distance x. The outflow end of the outer stent 120 is connected to the outflow end of the inner stent 110. The outer stent 120 can be made of shape memory metal material, medical stainless steel or polymer material. The outer stent 120 has a certain elastic deformation performance. When the outer stent 120 is squeezed, the outer stent 120 produces elastic deformation to adapt to the squeezing force. The diameter of the outer stent 120 is slightly larger than the diameter of the valve ring. After the valve prosthesis 100 is implanted in the human body, the outer stent 120 fits the valve ring of the human body and has a certain elastic force.

[0038] like Figure 3As shown, the side wall of the outer support 120 is inclined relative to the side wall of the inner support 110, and the side wall of the outer support 120 and the side wall of the inner support 110 have a certain angle a, and the angle a between the side wall of the outer support 120 and the side wall of the inner support 110 is between 30-60°, and specifically, the angle a can be 30°, 45°, 50° or 60°. The distance between the inner wall of the outer support 120 and the outer wall of the inner support 110 increases from the outflow end 142 to the outflow end 142.

[0039] One end of the elastic member 130 is connected to the outer support 120, and the other end of the elastic member 130 is connected to the inner support 110, and the elastic member 130 is located between the outer support 120 and the inner support 110. When one end of the elastic member 130 is squeezed, the elastic member 130 can be elastically deformed. Specifically, the elastic member 130 is made of an elastic material, and the elastic material can be a shape memory alloy or an elastic medical stainless steel material. The elastic member 130 can be a rod-shaped member, and the two ends of the elastic member 130 are respectively welded or integrally connected to the inner support 110 and the outer support 120. It should be noted that the integral connection in this embodiment refers to the inner support 110, the outer support 120 and the elastic member 130 being integrally cut and formed by shape memory material. The elastic member 130 can be arranged horizontally (i.e., along the radial direction of the inner support 110) or can be arranged tilted relative to the inner support 110. After the valve prosthesis 100 is implanted in the human body, when the outer stent 120 is subjected to the contraction force of the valve ring and moves toward the inner stent 110, the outer stent 120 squeezes the elastic member 130, the elastic member 130 is elastically deformed and provides a certain supporting force for the outer stent 120, one end of the elastic member 130 moves toward the inner stent 110, the elastic member 130 bends and deforms to form an arc, and at the same time transfers part of the extrusion force exerted on the outer stent 120 to the inner stent 110.

[0040] Therefore, by connecting the outflow end of the inner layer support 110 and the outflow end of the outer layer support 120, the inner wall of the outer layer support 120 and the outer wall of the inner layer support 110 are spaced apart except at the connection point, so that there is a certain deformation space between the outer layer support 120 and the inner layer support 110. Therefore, when the outer layer support 120 is squeezed and deformed, the outer layer support 120 can be deformed in the deformation space, thereby reducing the probability of the outer layer support 120 squeezing the inner layer support 110 and affecting the leaflet assembly 150. When the outer layer support 120 is deformed under pressure, one end of the elastic member 130 is connected to the outer layer support 120, and the other end of the elastic member 130 is connected to the inner layer support 110, so that the deformation force on the outer layer support 120 can be partially offset by the elastic deformation of the elastic member 130 and the deformation of the inner layer support 110, thereby dispersing the force on the outer layer support 120 at the valve ring, and further reducing the stress concentration at the connection node between the outer layer support 120 and the inner layer support 110 at the outflow end 142, avoiding the outer layer support 120 and the inner layer support 110 from breaking at the connection point, and in addition, the radial supporting force of the outer layer support 120 can be increased, and the fit between the outer layer support 120 and the valve ring can be improved.

[0041] like Figure 3 , Figure 4 As shown, the leaflet assembly 150 is connected to the inner layer support 110 , and the leaflet assembly 150 is located on the inner side of the inner layer support 110 , and the leaflet assembly 150 is far away from the position where the inner layer support 110 is connected to the elastic member 130 .

[0042] The leaflet assembly 150 is sutured to the inner wall of the inner layer support 110, and there is a certain spacing distance between the position where the leaflet assembly 150 is connected to the elastic member 130 and the inner layer support 110. Specifically, the leaflet assembly 150 can be set at a first position in the axial direction of the inner layer support 110, and the elastic member 130 is connected to the inner layer support 110 at a second position in the axial direction, and the proximal end of the first position and the second position have a certain spacing distance x2 in the axial direction.

[0043] Specifically, the inner layer support 110 includes a first inflow section 111, a first middle section 112 and a first outflow section 113, the first inflow section 111 is located at the inflow end of the inner layer support 110, the first outflow section 113 is located at the outflow end of the inner layer support 110, and the first middle section 112 is located between the inflow section and the outflow section. In one embodiment, the elastic member 130 is connected to the first inflow section 111, and the leaflet assembly 150 is connected to the first middle section 112 or the first outflow section 113. In another embodiment, the elastic member 130 is connected to the first middle section 112, and the leaflet assembly 150 is connected to the first inflow section 111 or the first outflow section 113. In another embodiment, the elastic member 130 is connected to the first outflow section 113, and the leaflet assembly 150 is connected to the first inflow section 111 or the first middle section 112.

[0044] In this way, by arranging the leaflet assembly 150 away from the position where the inner layer support 110 is connected to the elastic member 130, the leaflet assembly 150 and the position where the inner layer support 110 is connected to the elastic member 130 have a certain spacing distance. When the deformation force of the outer layer support 120 is too large and is transmitted to the inner layer support 110 through the elastic member 130, the leaflet assembly 150 can avoid the deformation point of the inner layer support 110, thereby reducing the influence of the deformation of the inner layer support 110 on the leaflet assembly 150.

[0045] like Figure 4 As shown, one end of the elastic member 130 is connected to the middle section of the outer layer support 120 , and the other end of the elastic member 130 is connected to the outflow section of the inner layer support 110 , and the leaflet assembly 150 is located in the middle section of the inner layer support 110 .

[0046] The outer layer stent 120 includes a second inflow section 121, a second middle section 122, and a second outflow section 123 connected in sequence. The second inflow section 121 extends from the inflow end 141 toward the outflow end 142. The second inflow section 121 is bent from the inflow end 141 toward the direction close to the inner layer stent 110. The diameter of the second inflow section 121 gradually decreases from the inflow end 141 toward the outflow end 142. The radial projection of the second middle section 122 covers the first inflow section 111 and the first middle section 112. The second outflow section 123 is flush with the first outflow section 113. The outflow end 142 of the outer layer stent 120 is connected to the outflow end 142 of the inner layer stent 110. The leaflet assembly 150 is sutured to the first middle section 112. One end of the elastic member 130 is connected to the first middle section 112, and the other end of the elastic member 130 is connected to the first outflow section 113. When the elastic member 130 is squeezed by the outer support 120, the elastic member 130 is deformed toward the outer support 120, and the contact area between the elastic member 130 and the outer support 120 increases. After the elastic member 130 is bent, the concave surface of the elastic member 130 faces the outflow end 142, and the convex surface of the elastic member 130 faces the inflow end 141. The greater the deformation of the outer support 120 toward the inner support 110, the more the elastic member 130 is bent, the larger the contact area between the elastic member 130 and the outer support 120, and the stronger the interference of the elastic member 130 with the deformation of the outer support 120, thereby increasing the supporting capacity of the elastic member 130 to the outer support 120. In another embodiment, the concave surface of the elastic member 130 can also face the inflow end 141, and the convex surface of the elastic member 130 can face the outflow end 141.

[0047] In other embodiments, Figure 5As shown, one end of the elastic member 130 is connected to the inflow section of the outer support 120, and the other end of the elastic member 130 is connected to the outflow section of the inner support 110. That is, one end of the elastic member 130 is connected to the second inflow section 121, and the other end of the elastic member 130 is connected to the first outflow section 113. Specifically, the elastic member 130 is connected to the flared structure of the first outflow section 113.

[0048] The advantage of such a setting is that, by connecting one end of the elastic member 130 to the middle section of the outer stent 120 and the other end of the elastic member 130 to the outflow section of the inner stent 110, the elastic member 130 can be arranged obliquely relative to the outer stent 120. When the outer stent 120 is deformed toward the inner stent 110, the elastic member 130 can be partially attached to the outer stent 120. The greater the deformation of the outer stent 120, the greater the attachment area of ​​the elastic member 130 and the outer stent 120, thereby the greater the interference with the deformation of the outer stent 120. By connecting the leaflet assembly 150 to the middle section of the inner stent 110, the leaflet assembly 150 can avoid the connection point between the inner stent 110 and the elastic member 130, and the leaflet assembly 150 can avoid the deformation point of the inner stent 110, thereby reducing the influence of the deformation of the inner stent 110 on the leaflet assembly 150.

[0049] The elastic member 130 is provided with a fitting portion 131 , and the fitting portion 131 at least partially fits with the outer support 120 when the elastic member 130 is deformed.

[0050] For example, in one embodiment, Figure 6 As shown, the elastic member 130 includes an arc-shaped rod having an arc-shaped structure, the arc-shaped rod is a fitting portion 131 of the elastic member 130, a convex surface 1311 of the arc-shaped rod is arranged toward the inflow end 141, and a concave surface 1312 of the arc-shaped rod is arranged toward the inflow end 141. The greater the deformation of the outer layer support 120 toward the inner layer support 110, the more the elastic member 130 is bent, and the larger the fitting area between the elastic member 130 and the outer layer support 120 is.

[0051] In another embodiment, if Figure 7As shown, the elastic member 130 includes a first arm 132 and a second arm 133, the first arm 132 and the second arm 133 are arranged at a predetermined angle, one end of the first arm 132 is connected to the inner layer support 110, the other end of the first arm 132 is connected to the second arm 133, the second arm 133 is connected to the outer layer support 120, and the second arm 133 forms the fitting portion 131. When the outer layer support 120 squeezes the elastic member 130, the angle between the first arm 132 and the second arm 133 becomes smaller, the angle between the second arm 133 and the outer layer support 120 becomes smaller, and the fitting area between the second arm 133 and the outer layer support 120 increases. The stronger the squeezing force on the elastic member 130, the smaller the angle between the first arm 132 and the second arm 133, and the larger the fitting area between the second arm 133 and the outer layer support 120, so that the second arm 133 interferes more strongly with the outer layer support 120.

[0052] In this way, by providing a fitting portion 131 on the elastic member 130, the fitting portion 131 at least partially fits with the outer layer support 120 when the elastic member 130 is deformed, so that the greater the deformation of the elastic member 130, the larger the fitting area between the elastic member 130 and the outer layer support 120, thereby the stronger the interference with the outer layer support 120, and the possibility of the outer layer support 120 squeezing the middle section is reduced.

[0053] like Figure 4 and Figure 5 As shown, the outflow section (ie, the first outflow section 113 ) of the inner layer support 110 is at least partially bent toward the radial outside to form a flared structure, and the elastic member 130 is connected to the flared structure.

[0054] The first outflow section 113 is bent radially outward to form a bent section, and the bent section forms a flared structure in the circumferential direction. The diameter of the first outflow section 113 increases from a position close to the middle section to a position close to the outflow end 142, and the end of the first outflow section 113 is connected to the end of the second outflow section 123. One end of the elastic member 130 is connected to the bent section of the first outflow section 113, and the elastic member 130 can be welded or integrally connected to the first outflow section 113. It should be noted that the integral connection refers to a structure in which the elastic member 130 and the outflow section are integrally connected by laser cutting. The outflow section of the outer layer support 120 is bent toward the inner layer support 110, and the first outflow section 113 is bent toward the outer layer support 120. The end of the outer layer support 120 is connected to the end of the inner layer support 110 to form an arc structure. The concave surface of the arc structure faces the inflow end 141, and the convex surface of the arc structure faces the outflow end 142. The end point of the arc structure farthest from the inflow end 141 forms the outflow end 142.

[0055] In some embodiments, the curvature of the first outflow section 113 decreases from the position close to the middle section to the position close to the outflow end 142. In this embodiment, the curvature of the first outflow section 113 means that points at different positions of the first outflow section 113 have different curvature circles, and the curvature is the reciprocal of the radius of the curvature circle, that is, k=1 / r, where k is the curvature and r is the radius of the curvature circle. The curvature represents the curvature of the first outflow section 113. The smaller the curvature, the smaller the curvature of the outflow section, and the larger the curvature, the greater the curvature of the first outflow section 113.

[0056] When the elastic member 130 is squeezed and bent by the outer support 120, the elastic member 130 is deformed and generates stress, which is transmitted to the first outflow section 113. The first outflow section 113 is deformed toward the inner side of the inner support 110 by the stress of the elastic member 130. When the outer support 120 is reset, the elastic member 130 is reset following the outer support 120, and the first outflow section 113 is reset following the elastic member 130. In the axial cross-sectional schematic diagram of the inner support 110, the first outflow section 113 is bent toward the radial outer side, the first middle section 112 is arranged along the axial direction, and the first outflow section 113 and the first middle section 112 have a certain angle, which is between 30° and 80°. Specifically, the angle between the first outflow section 113 and the first middle section 112 can be 30°, 45°, 50°, 60° or 80°. When the elastic member 130 presses the outflow section, the first outflow section 113 may be deformed toward the radial inside.

[0057] Thus, by bending the first outflow section 113 toward the radial outside, a flared structure is formed in the circumferential direction of the first outflow section 113, and the flared structure is connected to the elastic member 130. When the elastic member 130 is squeezed by the outer layer support 120, on the one hand, the flared structure can be deformed toward the radial inside to adapt to the stress applied by the elastic member 130 to the inner layer support 110. On the other hand, since the first outflow section 113 is bent toward the radial outside, the flared structure and the first middle section 114 have a certain angle, so that the flared structure has a certain space for deformation toward the radial inside. When the first outflow section 113 is deformed toward the radial inside, the flared structure provides a certain deformation margin for the first outflow section 113, thereby preventing the first outflow section 113 from driving the first middle section 114 to deform toward the radial inside, thereby preventing the deformation of the first middle section 114 from causing the leaflet assembly 150 to deform.

[0058] like Figure 5As shown, the angle between the elastic member 130 and the first outflow section 113 is between 30° and 80°. The angle between the elastic member 130 and the first outflow section 113 refers to: the angle between the elastic member 130 and the side wall of the first outflow section 113. The angle between the elastic member 130 and the first outflow section 113 is between 30° and 80°, and specifically, the angle between the elastic member 130 and the first outflow section 113 can be 30°, 45°, 50°, 60° or 80°.

[0059] The outer layer support 120 includes a plurality of outer skeleton units arranged along the circumferential direction, two adjacent outer skeleton units are arranged at intervals, and the elastic member 130 is connected to the outer skeleton units.

[0060] The outer layer support 120 includes multiple exoskeleton units, all of which are connected to the outflow end 142 of the inner layer support 110. Two adjacent exoskeleton units are spaced apart in the circumferential direction, and two adjacent exoskeleton units have a certain spacing distance in the circumferential direction. Two adjacent exoskeleton units have a certain partition space in the circumferential direction. Two adjacent exoskeleton units can deform or move in the partition space. The partition space isolates the transmission of force between the two adjacent exoskeleton units so that the deformation of the two exoskeleton units will not interfere with each other.

[0061] For example, in one embodiment, the exoskeleton units are in a diamond structure, and the multiple exoskeleton units include a first exoskeleton unit 124 and a second exoskeleton unit 125 that are adjacent to each other in the circumferential direction, and the first exoskeleton unit 124 includes a first rod 1241, a second rod 1242, a third rod 1243 and a fourth rod 1244, and the first rod 1241, the second rod 1242, the third rod 1243 and the fourth rod 1244 are connected end to end in sequence to form a diamond structure, wherein the first rod 1241 and the second rod 1242 are connected to form a first vertex, the second rod 1242 and the third rod 1243 are connected to form a second vertex, the third rod 1243 and the fourth rod 1244 are connected to form a third vertex, and the fourth rod 1244 and the first rod 1241 are connected to form a fourth vertex. The second exoskeleton unit 125 includes a fifth rod 1251, a sixth rod 1252, a seventh rod 1253 and an eighth rod 1254, which are connected end to end to form a diamond structure, wherein the fifth rod 1251 and the sixth rod 1252 are connected to form a fifth vertex, the sixth rod 1252 and the seventh rod 1253 are connected to form a sixth vertex, the seventh rod 1253 and the eighth rod 1254 are connected to form a seventh vertex, and the eighth rod 1254 and the fifth rod 1251 are connected to form an eighth vertex. The second vertex is spaced from the sixth vertex, so that the first exoskeleton unit 124 and the second exoskeleton unit 125 are spaced from each other.

[0062] It is understood that in other embodiments, the exoskeleton unit may also be in a triangular structure, a pentagonal structure or a rod-shaped structure.

[0063] like Fig. 9 As shown, the inner layer skeleton includes a plurality of inner skeleton units arranged in the circumferential direction, and two adjacent inner skeleton units are connected circumferentially. Two adjacent inner skeleton units are fixedly connected in the circumferential direction, and two adjacent inner skeleton units are fixedly connected or connected as one body. The deformation stress between two adjacent inner skeleton units can be transmitted to each other. For example, in one embodiment, the inner skeleton unit is a diamond structure, and the plurality of inner skeleton units include a first inner skeleton unit 114 and a second inner skeleton unit 115 adjacent in the circumferential direction, and the first inner skeleton unit 114 has a first vertex 1141 and a second vertex 1142 in the circumferential direction, and the second inner skeleton unit 115 has a third vertex 1151 and a fourth vertex 1152 in the circumferential direction, wherein the second vertex 1142 and the third vertex 1151 are adjacent, and the second vertex 1142 and the third vertex 1151 are fixedly connected. The two ends of the elastic member 130 are respectively connected to the inner layer skeleton and the outer layer skeleton.

[0064] In this way, the outer layer support 120 includes a plurality of outer frame units spaced apart along the circumferential direction, so that a stress isolation space is provided between two adjacent outer frame units, and the deformation of the two adjacent outer frame units will not interfere with each other, so that the outer layer support 120 can better adapt to the beating of the heart. The inner layer support 110 includes a plurality of inner frame units connected along the circumferential direction, so that the two adjacent inner frame units can interfere with each other, thereby having better structural stability, avoiding the outer layer frame from pulling the inner layer frame to deform through the elastic member 130, and ensuring that the leaflet assembly 150 can maintain structural stability.

[0065] Embodiment 2

[0066] The difference between this embodiment and the first embodiment is that Fig.10As shown, the valve prosthesis 100 further includes a first coating 161, a second coating 162 and a third coating 163, wherein the first coating 161 is disposed on the outer wall of the outer stent 120, the second coating 162 is disposed on the inner wall of the inner stent 110, the first coating 161 and the second coating 162 are connected at the outflow end 142 of the inner stent 110, the third coating 163 is located between the inner stent 110 and the outer stent 120, the third coating 163 is connected to the first coating 161 near the edge of the outer stent 120, the third coating 163 is connected to the second coating 162 near the edge of the inner stent 110, and the first coating 161, the second coating 162 and the third coating 163 are enclosed to form a sealed cavity structure. The third coating 163 can be located on a side of the elastic member 130 near the inflow end 141, or can be disposed on a side wall of the elastic member 130 near the inflow end. The sealed cavity structure formed by the first coating 161, the second coating 162, and the third coating 163 is used to seal the area between the elastic member 130, the inner layer support 110, and the outer layer support 120 (especially the area of ​​the elastic member close to the outflow end) to prevent blood from entering the area to form a thrombus and hinder the deformation of the elastic member 130.

[0067] The first coating 161 is connected to the outer wall of the outer layer support 120 and extends from the inflow end 141 of the outer layer support 120 toward the outflow end 142. The second coating 162 is connected to the inner wall of the inner layer support 110 and extends from the inflow end 141 of the inner layer support 110 toward the outflow end 142. The first coating 161 and the second coating 162 are connected at the connection point of the outer layer support 120 and the inner layer support 110 in the outflow section. The first coating 161 and the second coating 162 can be sutured or hot-pressed. In some other embodiments, the first coating 161 and the second coating 162 may be the same coating, for example, the coating extends from the outer wall of the outer stent 120 and bypasses the outflow section to cover the inner wall of the inner stent 110, so that the coating can cover both the outer wall of the outer stent 120 and the inner wall of the inner stent 110, wherein the coating located on the outer wall of the outer stent 120 is the first coating 161, and the coating located on the inner wall of the inner stent 110 is the second coating 162. The first coating 161 may be sutured or hot-pressed to the outer stent 120. The second coating 162 may be sutured or hot-pressed to the inner stent 110.

[0068] The third coating 163 is located on the side of the elastic member 130 close to the outflow section of the inner layer support 110, the third coating 163 is located between the inner layer support 110 and the outer layer support 120, and the third coating 163 is circumferentially arranged around the inner layer support 110. The third coating 163 includes an inner edge and an outer edge. The outer edge of the third coating 163 refers to the edge of the third coating 163 away from the inner layer support 110, and the inner edge of the third coating 163 refers to the edge of the third coating 163 close to the inner layer support The edge of the third coating 110, the outer edge of the third coating 163 is connected to the first coating 161, the inner edge of the third coating 163 is connected to the second coating 162, the third coating 163 is sutured or hot-pressed and bonded to the first coating 161, the third coating 163 is sutured or hot-pressed and bonded to the second coating 162, the third coating 163, the second coating 162 and the first coating 161 are enclosed to form a closed cavity structure, and the elastic member 130 is located in the sealed cavity structure.

[0069] In this way, the first coating 161 covers the outer wall of the outer layer stent 120, and the second coating 162 covers the inner wall of the inner layer stent 110. The first coating 161 and the second coating 162 are connected at the outflow end 142 of the inner layer stent 110, so that the first coating 161 and the second coating 162 can cover the gap between the inner layer stent 110 and the outer layer stent 120, thereby blocking the gap between the inner layer stent 110 and the outer layer stent 120 and preventing blood from overflowing from the gap between the inner layer stent 110 and the outer layer stent 120 to form paravalvular leakage. The third coating 163 is then located on a side of the elastic member 130 close to the outflow end 142 of the inner stent 110, and the third coating 163 is respectively connected to the first coating 161 and the second coating 162, so that the third coating 163, the second coating 162 and the first coating 161 enclose a closed space, thereby preventing blood from entering the closed space. By arranging the third coating 163 on a side of the elastic member 130 away from the outflow end 142, the elastic member 130 can be accommodated in the closed space. After the valve prosthesis 100 is implanted in the human body, the elastic member 130 can be deformed in the closed space, maintaining the flexibility of deformation of the elastic member 130, and preventing blood from forming accumulated thrombus in the space of the elastic member 130 close to the outflow end 142 of the inner stent 110, thereby interfering with the deformation of the elastic member 130.

[0070] There are multiple elastic members 130, all of which are arranged at intervals around the inner layer support 110, and the third coating 163 covers all of the elastic members 130. Multiple elastic members 130 are arranged at intervals along the circumference of the inner layer support 110, and the third coating 163 covers all of the elastic members 130. The third coating 163 fits the side wall of the elastic member 130 close to the inflow end 141, and the third coating 163 forms an isolation barrier on the side of the elastic member 130 close to the inflow end 141 to prevent blood flow from entering the space between the elastic member 130 and the first coating 161 and the second coating 162 to form accumulated thrombus.

[0071] It can be understood that in another embodiment, the third coating 163 can also be disposed on a side of the elastic member 130 close to the outflow end 142 .

[0072] like Fig.11 As shown, the area between the outer layer support 120 and the inner layer support 110 includes a first area 171 and a second area 172 adjacent to each other in the circumferential direction, and the distribution density of the elastic member 130 in the first area 171 is greater than that in the second area 172 .

[0073] It should be noted that the human valve ring is a D-shaped structure, including a straight section and an arc section. After the valve prosthesis 100 is implanted in the human body, the first area 171 corresponds to the straight section, and the second area 172 corresponds to the arc section. In the straight section, the extrusion force on the outer stent 120 in the first area 171 is greater than the extrusion force on the second area 172. The area between the outer stent 120 and the inner stent 110 refers to the space formed by the outer stent 120 and the inner stent 110 being spaced apart, and the elastic member 130 is distributed in the space.

[0074] The distribution density of the elastic members 130 refers to the number of elastic members 130 per unit area. For example, in the top view of the valve prosthesis 100, the axial projection area of ​​the first region 171 is defined as x1, the axial area of ​​the second region 172 is defined as x2, the number of elastic members 130 in the first region 171 is a1, and the number of elastic members 130 in the second region 172 is a2. Then, the distribution density of the elastic members 130 in the first region 171 is: D1=a1 / x1; the distribution density of the elastic members 130 in the second region 172 is D2=a2 / x2, D1>D2.

[0075] In this way, the outer layer support 120 includes a first area 171 and a second area 172 that are adjacent to each other in the circumferential direction, and the distribution density of the elastic member 130 in the first area 171 is greater than that in the second area 172, so that the support of the elastic member 130 to the outer layer support 120 in the first area 171 is greater than that in the second area 172, thereby preventing the outer layer support 120 from being excessively squeezed by the straight section and causing deformation of the middle section of the inner layer support 110.

[0076] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0077] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A valve prosthesis, characterized in that: It comprises an inner layer support, an outer layer support and an elastic member, wherein the inner layer support is inserted into the outer layer support and connected to the outer layer support, and two ends of the elastic member are respectively connected to the outer layer support and the inner layer support.

2. The valve prosthesis according to claim 1, characterized in that: One end of the elastic member is connected to the inflow section or the middle section of the outer layer support, and the other end of the elastic member is connected to the outflow section of the inner layer support.

3. The valve prosthesis according to claim 2, characterized in that: The outflow section of the inner layer support is at least partially bent toward the radial outside to form a flared structure, and the elastic member is connected to the flared structure.

4. The valve prosthesis according to claim 1, characterized in that: The elastic member includes a fitting portion, and when the elastic member is deformed, at least a portion of the fitting portion can fit with the outer layer support.

5. The valve prosthesis according to claim 4, characterized in that: The fitting portion is in an arc-shaped structure, the convex surface of the arc-shaped structure is arranged toward the inflow end, and the concave surface of the arc-shaped structure is arranged toward the outflow end.

6. The valve prosthesis according to claim 4, characterized in that: The elastic member includes a first rod and a second rod connected to each other, the first rod and the second rod are arranged at a predetermined angle, the end of the first rod away from the second rod is connected to the outer layer support, the end of the second rod away from the first end is connected to the inner layer support, and the first rod forms the fitting portion.

7. The valve prosthesis according to claim 1, characterized in that: The valve prosthesis also includes a first coating, a second coating and a third coating, wherein the first coating is arranged on the outer wall of the outer layer stent, the second coating is arranged on the inner wall of the inner layer stent, the first coating and the second coating are connected at the outflow end of the inner layer stent, the third coating is located between the inner layer stent and the outer layer stent and is respectively connected to the first coating and the second coating, the first coating, the second coating and the third coating form a sealed cavity structure, and the sealed cavity structure is used to prevent blood flow from entering the area between the elastic member, the inner stent and the outer stent.

8. The valve prosthesis according to claim 7, characterized in that: There are a plurality of elastic members, all of which are arranged around the inner support, and the third coating is arranged on the inflow side of all of the elastic members.

9. The valve prosthesis according to claim 8, characterized in that: The area between the outer layer support and the inner layer support includes a first area and a second area adjacent to each other in the circumferential direction, and the distribution density of the elastic members in the first area is greater than that in the second area.

10. The valve prosthesis according to claim 1, characterized in that: The outer layer support comprises a plurality of rhombus-shaped frames arranged along the circumferential direction, two adjacent rhombus-shaped frames are arranged at intervals, and the elastic member is connected to the rhombus-shaped frames.

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