Expandable prosthetic valve prosthesis

Abstract

The utility model relates to an expandable artificial valve prosthesis which is characterized in that channels are formed in an elastic valve prosthesis, and a Tesla valve structure is arranged in each channel; an instrument guide hole is formed in the elastic valve prosthesis and can be communicated with the inflow end and the outflow end; the end face of the inflow end and the end face of the outflow end are each provided with an elastic sealing body used for closing the instrument guide hole, each elastic sealing body is provided with a disconnection part, and the disconnection parts are in a normally-closed state under the elastic force action of the elastic sealing bodies so as to close the instrument guide holes. A transition layer is circumferentially arranged on the outer wall of the elastic valve prosthesis in a surrounding manner, and the transition layer has plasticity; the valve frames are arranged at the inflow end and the outflow end respectively and connected with the transition layer, or the valve frames are directly and fixedly connected with the elastic valve prosthesis. The expandable artificial valve prosthesis disclosed by the utility model can be expanded, so that the overall diameter size of the expandable artificial valve prosthesis disclosed by the utility model is changed, and the expandable artificial valve prosthesis can be adapted to heart structure tissues with larger sizes.

Description

Technical Field

[0001] This patent relates to the technical field of medical devices, and more particularly, to an expandable artificial valve prosthesis. Background Art

[0002] For patients with heart valve diseases and congenital heart diseases, heart valve replacement is an effective medical means, which can effectively improve heart function. Currently, the surgeries include interventional and surgical methods. Regardless of the surgical form, the valve prosthesis consists of a main valve frame and a valve. The main valve frame is generally composed of a metal or non-metal with relatively high rigidity, which plays a role of rigid support. The valve is mostly made of chemically treated animal raw materials (such as porcine pericardium, etc.) or polymer composite materials to achieve the function of a one-way valve.

[0003] However, for children who receive heart valve replacement, as they grow older, the patient's heart becomes larger and larger, while the size of the materials that make up the valve remains unchanged. The problem is that the valve prosthesis is mismatched with the diseased tissue, resulting in the risks of valve regurgitation, perivalvular leakage, valve displacement, and even slippage. Therefore, these patients must undergo multiple surgeries to replace larger valves, which brings huge risks and medical costs.

[0004] Therefore, it is necessary to design a valve prosthesis that can be expanded minimally invasively and adjusted in size to fit the growing heart diseased tissue of children and help maintain normal function. Summary of the Invention

[0005] The purpose of this patent is to provide an expandable artificial valve prosthesis to overcome the above-mentioned existing defects.

[0006] To achieve the above purpose of this patent, the following technical solutions are adopted:

[0007] This application provides an expandable artificial valve prosthesis, including an elastic valve prosthesis, a transition layer, an elastic seal, and a valve frame;

[0008] A channel is provided inside the elastic valve prosthesis, and the channel penetrates through the elastic valve prosthesis. A Tesla valve structure is provided in each channel; wherein,

[0009] Along the length direction of the channel, from the inflow end to the outflow end of the elastic valve prosthesis is the low-resistance direction of the Tesla valve structure, and from the outflow end to the inflow end of the elastic valve prosthesis is the high-resistance direction of the Tesla valve structure;

[0010] An instrument guiding hole is provided inside the elastic valve prosthesis, and the instrument guiding hole can communicate the inflow end and the outflow end;

[0011] On the end faces of the inflow end and the outflow end, elastic seals for closing the instrument guiding holes are provided. The elastic seals are provided with disconnection parts, and the disconnection parts are in a normally closed state under the elastic force of the elastic seals to close the instrument guiding holes;

[0012] A transition layer is circumferentially arranged around the outer wall of the elastic valve prosthesis, and the transition layer has plasticity;

[0013] The valve frames are respectively arranged at the inflow end and the outflow end. The valve frames are connected to the transition layer, or the valve frames are directly fixedly connected to the elastic valve prosthesis.

[0014] Further, there are a plurality of the channels, and the plurality of channels are circumferentially distributed along the elastic valve prosthesis. The instrument guiding holes are arranged inside the plurality of circumferentially distributed channels, and the instrument guiding holes are coaxially arranged with the elastic valve prosthesis.

[0015] Further, the elastic valve prosthesis includes a valve body, an inflow end connecting part and an outflow end connecting part arranged at both ends of the valve body;

[0016] The inflow end connecting part and the valve body form an inflow hole, and the inflow hole is communicated with the channel;

[0017] The outflow end connecting part and the valve body form an outflow hole, and the outflow hole is communicated with the channel;

[0018] The channel is arranged inside the valve body;

[0019] The instrument guiding hole is arranged inside the valve body;

[0020] The transition layer is circumferentially arranged around the outer wall of the valve body;

[0021] The valve frame includes a first valve frame and a second valve frame;

[0022] A transition layer is also arranged on the outer wall of the inflow end connecting part, and the first valve frame is connected to the transition layer on the inflow end connecting part; a transition layer is also arranged on the outer wall of the outflow end connecting part, and the second valve frame is connected to the transition layer on the outflow end connecting part; or,

[0023] The first valve frame is directly fixedly connected to the inflow end connecting part, and the second valve frame is directly fixedly connected to the outflow end connecting part.

[0024] Further, the elastic seal includes a hollow plug body. An end cover is arranged on the end face of the hollow plug body close to the inflow end, and the disconnection part is arranged on the end cover;

[0025] The hollow plugs are respectively embedded on the end faces of the inflow end and the outflow end.

[0026] Further, the Tesla valve structure includes a first flow guiding unit plate, a second flow guiding unit plate, a first bump and a second bump;

[0027] The first flow guiding unit plate and the second flow guiding unit plate are oppositely arranged on the inner wall of the channel;

[0028] A plurality of the first bumps are arranged on the inner wall of the channel inside the first flow guiding unit plate;

[0029] A plurality of the second bumps are arranged on the inner wall of the channel inside the second flow guiding unit plate;

[0030] A plurality of the first bumps and the second bumps are arranged in cooperation with the first flow guiding unit plate and the second flow guiding unit plate, so as to form the Tesla valve structure, and a main channel and a plurality of branch channels communicated with the main channel are formed in the channel.

[0031] Further, the first flow guiding unit plate includes a first baffle plate connected in sequence, the first baffle plate includes a first flow guiding plate and a first arc transition plate connected to the first flow guiding plate, and for two adjacent first flow guiding unit plates, the first flow guiding plate of one of the first flow guiding unit plates is connected to the first arc transition plate of the other first flow guiding unit plate;

[0032] The second flow guiding unit plate includes a second baffle plate connected in sequence, the second baffle plate includes a second flow guiding plate and a second arc transition plate connected to the second flow guiding plate, and for two adjacent second flow guiding unit plates, the second flow guiding plate of one of the second flow guiding unit plates is connected to the second arc transition plate of the other second flow guiding unit plate;

[0033] The first bump is arranged on the inner wall of the channel inside each first flow guiding unit plate. A first side channel is formed between the first bump and the corresponding first flow guiding plate, a first arc transition channel is formed between the first bump and the corresponding first arc transition plate, a first main channel is formed between the first bump and the corresponding second flow guiding plate, the first side channel is communicated with the first main channel, and the first arc transition channel communicates the first side channel and the first main channel to form a first branch channel arranged in a closed loop;

[0034] The second bump is disposed on the inner wall of the channel of each of the second diversion unit plates. Between the second bump and the corresponding second diversion plate, a second side channel is formed. Between the second bump and the corresponding second arc transition plate, a second arc transition channel is formed. Between the second bump and the corresponding first diversion plate, a second main channel is formed. The second side channel communicates with the second main channel, and the second arc transition channel communicates with the second side channel and the second main channel to form a second branch channel arranged in a closed loop;

[0035] The adjacent second main channel and the first main channel are sequentially connected to form the main channel;

[0036] The first branch channel and the second branch channel are distributed on both sides of the main channel along the extending direction of the main channel and are arranged in a staggered manner.

[0037] Further, the first diversion plate is a linear first diversion plate, the first bump is a rectangular first bump, the length direction of the rectangular first bump is the same as the length direction of the linear first diversion plate, and the first side channel formed between the rectangular first bump and the linear first diversion plate is a linear first side channel;

[0038] One end of the rectangular first bump is an arc end, and the first arc transition channel formed between the arc end and the first arc transition plate is a semi-circular first arc transition channel;

[0039] The second diversion plate is a linear second diversion plate, the second bump is a rectangular second bump, the length direction of the rectangular second bump is the same as the length direction of the linear second diversion plate, and the second side channel formed between the rectangular second bump and the linear second diversion plate is a linear second side channel;

[0040] One end of the rectangular second bump is an arc end, and the second arc transition channel formed between the arc end and the second arc transition plate is a semi-circular second arc transition channel;

[0041] The other end of the rectangular first bump is a pointed end, and the first main channel formed between the inclined surface of the pointed end and the corresponding linear second diversion plate is a linear first main channel;

[0042] The other end of the rectangular second bump is a pointed end, and the second main channel formed between the inclined surface of the pointed end and the corresponding linear first diversion plate is a linear second main channel;

[0043] The adjacent linear second main channel and the linear first main channel are sequentially connected to form the main channel.

[0044] Further, on the inner wall of the channel near the inflow end, an inflow end transition plate is provided. The inflow end transition plate is connected to the adjacent first arc transition plate. Between the inflow end transition plate and the corresponding linear second guide plate, a liquid inlet transition channel is formed, and the liquid inlet transition channel is communicated with the main channel;

[0045] On the inner wall of the channel near the outflow end, an outflow end transition plate is provided. The outflow end transition plate is connected to the adjacent linear first guide plate. Between the outflow end transition plate and the corresponding linear second guide plate, a liquid outlet transition channel is formed, and the liquid outlet transition channel is communicated with the main channel.

[0046] Further, the first guide plate is an arc-shaped first guide plate, and the first convex block is an arc-shaped first convex block. The outer convex arc surface of the arc-shaped first convex block can cover the arc-shaped first guide plate and the first arc transition plate. Between the outer convex arc surface and the arc-shaped first guide plate, the formed first side channel is an arc-shaped first side channel;

[0047] Between the arc-shaped first convex block and the first arc transition plate, the formed first arc transition channel is a semi-circular first arc transition channel;

[0048] The second guide plate is an arc-shaped second guide plate, and the second convex block is an arc-shaped second convex block. The outer convex arc surface of the arc-shaped second convex block can cover the arc-shaped second guide plate and the second arc transition plate. Between the arc-shaped second convex block and the arc-shaped second guide plate, the formed second side channel is an arc-shaped second side channel;

[0049] Between the arc-shaped second convex block and the second arc transition plate, the formed second arc transition channel is a semi-circular second arc transition channel;

[0050] The surface of the arc-shaped first convex block corresponding to the arc-shaped second guide plate is an inner concave arc surface. Between the inner concave arc surface and the arc-shaped second guide plate, the formed first main channel is an arc-shaped first main channel;

[0051] The surface of the arc-shaped second convex block corresponding to the arc-shaped first guide plate is an inner concave arc surface. Between the inner concave arc surface and the arc-shaped first guide plate, the formed second main channel is an arc-shaped second main channel;

[0052] The adjacent arc-shaped second main channel and arc-shaped first main channel are connected in sequence to form the main channel.

[0053] Further, on the inner wall of the channel near the inflow end, an inflow end transition plate is provided. The inflow end transition plate is connected to the adjacent arc-shaped first guide plate. Between the inflow end transition plate and the corresponding second arc transition plate, a liquid inlet transition channel is formed, and the liquid inlet transition channel is communicated with the main channel.

[0054] On the inner wall of the channel near the outflow end, an outflow end transition plate is provided. The outflow end transition plate is connected to the adjacent second arc transition plate. Between the outflow end transition plate and the corresponding arc-shaped first guide plate, a liquid outlet transition channel is formed, and the liquid outlet transition channel is communicated with the main channel.

[0055] Further, optimization holes are provided inside the elastic valve prosthesis.

[0056] Along the circumferential direction of the elastic valve prosthesis, the inside of the elastic valve prosthesis on both sides of the channel is a hollow structure.

[0057] Further, an inflow end conical surface is provided inside the pore wall of the inflow hole, and the inflow hole is communicated with the channel through the inflow end conical surface.

[0058] An outflow end conical surface is provided inside the pore wall of the outflow hole, and the outflow hole is communicated with the channel through the outflow end conical surface.

[0059] Adopting the above technical solutions, the present patent has the following beneficial effects:

[0060] When it is necessary to expand the expandable artificial valve prosthesis of the present application, the head end of the balloon catheter is passed through the disconnection part of one of the elastic seals, enters the instrument guiding hole, and passes out from the disconnection part of the other elastic seal along the instrument guiding hole. In this way, the balloon catheter is inserted into the inside of the elastic valve prosthesis.

[0061] Then, the balloon catheter is pressurized to expand the balloon of the balloon catheter to an appropriate size. Since the transition layer is plastic, under the action of the expanded balloon, the transition layer undergoes a radial deformation. The elastic valve prosthesis is pulled by the transition layer and undergoes a radial displacement. In this process, the diameters of the instrument guiding hole and the elastic seal are increased. Since the valve frame is connected to the transition layer, or the valve frame is directly fixedly connected to the elastic valve prosthesis, the valve frame also undergoes a radial deformation under the pull of the transition layer or the elastic valve prosthesis.

[0062] To sum up, under the external force of the expanded balloon, the overall outer diameter of the expandable artificial valve prosthesis of the present application becomes larger, and the channel of the Tesla valve structure inside the elastic valve prosthesis will undergo a radial displacement together with the elastic valve prosthesis. Therefore, the one-way flow function of the channel from the inflow end to the outflow end is not affected.

[0063] After deflating the balloon catheter and withdrawing the balloon catheter from the inside of the elastic valve prosthesis, due to the plasticity of the transition layer, the new size of the expandable artificial valve prosthesis of the present application after expansion can be maintained, thereby changing the overall diameter size of the expandable artificial valve prosthesis of the present application to be able to fit a larger-sized cardiac structural tissue. At the same time, the disconnection part of the elastic seal returns to the normally closed state under the action of its own elastic force, closing the instrument guide hole and avoiding the leakage of fluid from the instrument guide hole. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] In order to more clearly illustrate the specific embodiments of the present patent or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present patent. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0065] Figure 1 is a structural cross-sectional view of the expandable artificial valve prosthesis;

[0066] Figure 2 is a schematic diagram of the balloon catheter inserted into the inside of the elastic valve prosthesis;

[0067] Figure 3 is a schematic diagram of inflating the balloon inserted into the inside of the elastic valve prosthesis;

[0068] Figure 4 is a new schematic diagram of the expandable artificial valve prosthesis of the present application after expansion;

[0069] Figure 5 is a schematic diagram of the structure of the elastic seal;

[0070] Figure 6 is a structural cross-sectional view of the elastic valve prosthesis;

[0071] Figure 7 is a cross-sectional view of the structure of the first type of Tesla valve; (For the convenience of showing the structure, only one Tesla valve structure is shown, and the Tesla valve structures in other channels are the same as this one)

[0072] Figure 8 is a schematic diagram of the flow direction of the fluid inside the first type of Tesla valve structure when the fluid flows in from the low-resistance direction of the first type of Tesla valve structure;

[0073] Figure 9 is a schematic diagram of the flow direction of the fluid inside the first type of Tesla valve structure when the fluid flows in from the high-resistance direction of the first type of Tesla valve structure;

[0074] Figure 10 Schematic diagram of the first Tesla valve structure, where the included angle between the inflow end transition plate and the first arc transition plate is α;

[0075] Figure 11 Cross-sectional view of the second Tesla valve structure; (For the convenience of showing the structure, only one Tesla valve structure is shown, and the Tesla valve structures in other channels are the same as this one);

[0076] Figure 12 Schematic diagram of the flow direction of the fluid inside the second Tesla valve structure when the fluid flows in from the low-resistance direction of the second Tesla valve structure;

[0077] Figure 13 Schematic diagram of the flow direction of the fluid inside the second Tesla valve structure when the fluid flows in from the high-resistance direction of the second Tesla valve structure;

[0078] Figure 14 Schematic diagram of the second Tesla valve structure, where the included angle between the convex arc surface and the concave arc surface of the arc-shaped first convex block is β;

[0079] Figure 15 Schematic diagram of the second Tesla valve structure, where the included angle between the convex arc surface and the concave arc surface of the arc-shaped second convex block is β;

[0080] Figure 16 Top view of the valve body with three channels inside (the instrument guide hole and the elastic seal are hidden).

[0081] Reference numerals: 1 - valve frame; 2 - elastic valve prosthesis; 3 - channel; 4 - Tesla valve structure; 21 - inflow end; 22 - outflow end; 5 - first diversion unit plate; 6 - second diversion unit plate; 7 - first bump; 8 - second bump; 9 - main channel; 10 - branch channel; 51 - first baffle; 52 - first diversion plate; 53 - first arc transition plate; 61 - second baffle; 62 - second diversion plate; 63 - second arc transition plate; 11 - first side channel; 12 - first arc transition channel; 13 - first main channel; 14 - first branch channel; 15 - second side channel; 16 - second arc transition channel; 17 - second main channel; 18 - second branch channel; 521 - linear first diversion plate; 71 - rectangular first bump; 111 - linear first side channel; 19 - arc end; 121 - semi-circular first arc transition channel; 621 - linear second diversion plate; 81 - rectangular second bump; 151 - linear second side channel; 161 - semi-circular second arc transition channel; 20 - pointed end; 201 - inclined surface; 131 - linear first main channel; 171 - linear second main channel; 23 - inflow end transition plate; 24 - liquid inlet transition channel; 25 - outflow end transition plate; 26 - liquid outlet transition channel; 522 - arc-shaped first diversion plate; 72 - arc-shaped first bump; 27 - convex arc surface; 112 - arc-shaped first side channel; 622 - arc-shaped second diversion plate; 82 - arc-shaped second bump; 152 - arc-shaped second side channel; 33 - concave arc surface; 132 - arc-shaped first main channel; 172 - arc-shaped second main channel; 211 - inflow hole; 221 - outflow hole; 212 - inflow end conical surface; 222 - outflow end conical surface; 28 - inflow end connection part; 29 - outflow end connection part; 30 - optimized hole; 31 - hollow structure; 32 - transition layer; 34 - elastic seal; 35 - instrument guiding hole; 36 - disconnection part; 37 - balloon catheter; 38 - valve body; 39 - first valve frame; 40 - second valve frame; 41 - hollow plug body; 42 - end cap; 43 - balloon. Detailed implementation manners

[0082] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0083] In the description of the present invention, it should be noted that unless otherwise clearly specified and defined, the terms "installation", "connection", and "coupling" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0084] As Figure 1 shown, the expandable artificial valve prosthesis of the present application includes an elastic valve prosthesis 2, a transition layer 32, an elastic seal 34, and a valve frame 1;

[0085] A channel 3 is provided inside the elastic valve prosthesis 2, and the channel 3 penetrates through the elastic valve prosthesis 2. A Tesla valve structure 4 is provided in each channel 3; wherein,

[0086] Along the length direction of the channel 3, from the inflow end 21 to the outflow end 22 of the elastic valve prosthesis 2 is the low-resistance direction of the Tesla valve structure 4, and from the outflow end 22 to the inflow end 21 of the elastic valve prosthesis 2 is the high-resistance direction of the Tesla valve structure 4;

[0087] An instrument guiding hole 35 is provided inside the elastic valve prosthesis 2, and the instrument guiding hole 35 can communicate the inflow end 21 and the outflow end 22;

[0088] On the end faces of the inflow end 21 and the outflow end 22, an elastic seal 34 for closing the instrument guiding hole 35 is provided. The elastic seal 34 is provided with a breaking portion 36, and the breaking portion 36 is in a normally closed state under the elastic force of the elastic seal 34 to close the instrument guiding hole 35;

[0089] A transition layer 32 is circumferentially provided around the outer wall of the elastic valve prosthesis 2. The transition layer 32 has plasticity and is made of a plastically deformable material;

[0090] The valve frames 1 are respectively provided at the inflow end 21 and the outflow end 22. The valve frames 1 are connected to the transition layer 32, or the valve frames 1 are directly fixedly connected to the elastic valve prosthesis 2.

[0091] As Figure 2 shown, when it is necessary to expand the expandable artificial valve prosthesis of the present application, the head end of the balloon catheter 37 is passed through the breaking portion 36 of one of the elastic seals 34 (the head end of the balloon catheter 37 pushes open the breaking portion 36), enters the instrument guiding hole 35, and passes out through the breaking portion 36 of the other elastic seal 34 along the instrument guiding hole 35. In this way, the balloon catheter 37 is inserted into the inside of the elastic valve prosthesis 2.

[0092] AsFigure 3 As shown, the balloon catheter 37 is then pressurized to expand the balloon 43 of the balloon catheter 37 to an appropriate size. Since the transition layer 32 is plastic, under the action of the expanded balloon 43, the transition layer 32 undergoes a radial deformation. Under the traction of the transition layer 32, the elastic valve prosthesis 2 undergoes a radial displacement. This process will increase the diameters of the instrument guide hole 35 and the elastic seal 34. Since the valve frame 1 is connected to the transition layer 32, or the valve frame 1 is directly fixedly connected to the elastic valve prosthesis 2, therefore, under the traction of the transition layer 32 or the elastic valve prosthesis 2, the valve frame 1 also undergoes a radial deformation.

[0093] In summary, under the external force of the expanded balloon 43, the overall outer diameter of the expandable artificial valve prosthesis of the present application becomes larger, and the channel 3 of the Tesla valve structure 4 inside the elastic valve prosthesis 2 will undergo a radial displacement together with the elastic valve prosthesis 2. Therefore, the one-way flow function of the channel 3 from the inflow end 21 to the outflow end 22 is not affected.

[0094] As Figure 4 shown, after the balloon 43 is depressurized and the balloon catheter 37 is withdrawn from the inside of the elastic valve prosthesis 2, due to the plasticity of the transition layer 32, the new size of the expanded expandable artificial valve prosthesis of the present application is maintained, and thus the overall diameter size of the expandable artificial valve prosthesis of the present application is changed to be able to fit a larger-sized heart structure tissue. At the same time, the disconnection part 36 of the elastic seal 34 returns to the normally closed state under the action of its own elastic force, closing the instrument guide hole 35 to avoid the leakage of fluid from the instrument guide hole 35.

[0095] In addition, the present application is provided with a channel 3 having a Tesla valve structure 4 inside the elastic valve prosthesis 2 to replace the moving parts, i.e., valve leaflets, in the existing artificial valve prosthesis. As a result, there are no moving parts inside the expandable artificial valve prosthesis of the present application. Without moving parts, there is no mechanical movement (here, the mechanical movement refers to the opening and closing of the valve leaflets). Without mechanical movement, there is no problem of fatigue effect, thereby solving the problem that in the existing artificial valve prosthesis, due to the presence of valve leaflets, the valve leaflets will generate mechanical movement, and the valve leaflets with mechanical movement are prone to damage due to the fatigue effect.

[0096] The expandable artificial valve prosthesis of the present application omits the valve leaflets and processes such as membrane cutting and membrane sewing for the valve leaflets. Therefore, the expandable artificial valve prosthesis of the present application has a simple process, can be mass-produced automatically, and improves the qualification rate and production efficiency.

[0097] The main functions of the transition layer 32 are as follows: First, the plastic material can undergo plastic deformation and change its diameter size when subjected to a radial force, thereby achieving the purpose of adjusting the size of the elastic valve prosthesis 2. Second, it serves to connect and fix the valve frame 1 and the elastic valve prosthesis 2. Third, it has a sealing effect to prevent paravalvular leakage.

[0098] Specifically, there are multiple channels 3, and the multiple channels 3 are circumferentially distributed along the elastic valve prosthesis 2. The instrument guiding hole 35 is arranged inside the multiple circumferentially distributed channels 3, and the instrument guiding hole 35 is coaxially arranged with the elastic valve prosthesis 2.

[0099] In this way, the instrument guiding hole 35 can be arranged at the center of the multiple channels 3, which not only conforms to hemodynamics and ensures better use effects of the expandable artificial valve prosthesis of the present application, but also enables the inner balloon catheter 37 inserted into the elastic valve prosthesis 2 to be in the central position. With this arrangement, after the balloon 43 is inflated, the radial deformation generated by the transition layer 32 and the valve frame 1 can be more uniform along the circumferential direction of the elastic valve prosthesis 2. The radial displacement of the elastic valve prosthesis 2 and the channels 3 of the Tesla valve structure 4 inside the elastic valve prosthesis 2 can also be more uniform in the circumferential direction of the elastic valve prosthesis 2. With this arrangement, the overall diameter size of the expandable artificial valve prosthesis of the present application can change more uniformly in the circumferential direction of the elastic valve prosthesis 2, enabling better adaptation to larger-sized cardiac structural tissues.

[0100] Specifically, as Figure 1 shown, the elastic valve prosthesis 2 includes a valve body 38 and an inflow end connection part 28 and an outflow end connection part 29 arranged at both ends of the valve body 38;

[0101] The inflow end connection part 28 and the valve body 38 form an inflow hole 211, and the inflow hole 211 communicates with the channel 3;

[0102] The outflow end connection part 29 and the valve body 38 form an outflow hole 221, and the outflow hole 221 communicates with the channel 3;

[0103] The channel 3 is arranged inside the valve body 38;

[0104] The instrument guiding hole 35 is arranged inside the valve body 38;

[0105] The transition layer 32 is circumferentially arranged around the outer wall of the valve body 38;

[0106] The valve frame 1 includes a first valve frame 39 and a second valve frame 40;

[0107] A transition layer 32 is also provided on the outer wall of the inflow end connection part 28, and the first valve frame 39 is connected to the transition layer 32 on the inflow end connection part 28; a transition layer 32 is also provided on the outer wall of the outflow end connection part 29, and the second valve frame 40 is connected to the transition layer 32 on the outflow end connection part 29; or,

[0108] The first valve frame 39 is directly fixedly connected to the inflow end connection part 28, and the second valve frame 40 is directly fixedly connected to the outflow end connection part 29.

[0109] In this application, an inflow end connection part 28 and an outflow end connection part 29 are respectively provided at both ends of the valve body 38. Through the inflow end connection part 28 and the outflow end connection part 29, it is possible to prevent fluid from generating paravalvular leakage due to the irregular change of the fluid flow direction at the inflow end 21 and the outflow end 22 caused by the instantaneous change of the fluid flow path.

[0110] The lengths of the inflow end connection part 28 and the outflow end connection part 29 are ≥ 3 mm, preferably 4 - 10 mm.

[0111] For the connection method in which the first valve frame 39 is connected to the transition layer 32 on the inflow end connection part 28 and the second valve frame 40 is connected to the transition layer 32 on the outflow end connection part 29, under the action of the inflated balloon 43, the shape - deformable transition layer 32 on the inflow end connection part 28 and the outflow end connection part 29 can better pull the first valve frame 39 and the second valve frame 40, so that the first valve frame 39 and the second valve frame 40 can better generate radial deformation.

[0112] For the connection method in which the first valve frame 39 is directly fixedly connected to the inflow end connection part 28 and the second valve frame 40 is directly fixedly connected to the outflow end connection part 29, due to the lack of the shape - deformable transition layer 32, under the action of the inflated balloon 43, only the radial deformation of the inflow end connection part 28 and the outflow end connection part 29 can be relied on to pull the first valve frame 39 and the second valve frame 40, so that the first valve frame 39 and the second valve frame 40 generate radial deformation, and the effect may not be as good as the method with the transition layer 32 above.

[0113] Figure 1 In, the shown scheme is that the first valve frame 39 is connected to the transition layer 32 on the inflow end connection part 28, and the second valve frame 40 is connected to the transition layer 32 on the outflow end connection part 29. On the Figure 1 basis, removing the connection of the transition layer 32 on the inflow end connection part 28 and the outflow end connection part 29 can realize the scheme that the first valve frame 39 is directly fixedly connected to the inflow end connection part 28 and the second valve frame 40 is directly fixedly connected to the outflow end connection part 29. It can be adopted that when the elastic valve prosthesis 2 is formed, the first valve frame 39 is embedded in the inflow end connection part 28, the second valve frame 40 is embedded in the outflow end connection part 29, and after curing treatment, the fixation is completed.

[0114] Preferably, the first valve support 39 and the second valve support 40 are made of metal or non-metal materials. The metal material can be cobalt-chromium alloy, and the non-metal material can be polyoxymethylene (POM).

[0115] After being implanted into the human body, the first valve support 39 and the second valve support 40 play a role in anchoring the entire expandable artificial valve prosthesis.

[0116] Preferably, the elastic valve prosthesis 2 can be made of medical silicone, polyurethane or other polymer materials. The manufacturing process can be 3D printing or one-piece molding, and automated and batch production can be carried out to improve efficiency and qualification rate.

[0117] Specifically, as Figure 5 shown, the elastic seal 34 includes a hollow plug body 41. An end cap 42 is provided on the end face of the hollow plug body 41 close to the inflow end 21, and a break portion 36 is provided on the end cap 42;

[0118] The hollow plug body 41 is respectively embedded in the end faces of the inflow end 21 and the outflow end 22.

[0119] It should be noted that for the present application, the form of the break portion 36 can be various. For example, an arc-shaped break portion (arc-shaped break line), a straight-line break portion (straight-line break line), a cross-shaped break portion (cross-shaped break line), etc. As long as it can be satisfied that the instrument can push open the break portion 36 and pass through, and when there is no instrument, the break portion 36 can be closed.

[0120] Preferably, the elastic seal 34 can be made of high-elastic medical-grade silicone material.

[0121] Specifically, referring to Figure 6 , the Tesla valve structure 4 includes a first flow guiding unit plate 5, a second flow guiding unit plate 6, a first convex block 7 and a second convex block 8;

[0122] The first flow guiding unit plate 5 and the second flow guiding unit plate 6 are oppositely arranged on the inner wall of the channel 3;

[0123] A plurality of first convex blocks 7 are provided on the inner wall of the channel 3 inside the first flow guiding unit plate 5;

[0124] A plurality of second convex blocks 8 are provided on the inner wall of the channel 3 inside the second flow guiding unit plate 6;

[0125] The plurality of first convex blocks 7 and second convex blocks 8 are cooperatively arranged with the first flow guiding unit plate 5 and the second flow guiding unit plate 6, so as to form the Tesla valve structure 4 to form a main channel 9 and a plurality of branch channels 10 communicated with the main channel 9 in the channel 3.

[0126] Specifically, continue to refer to Figure 6, the first flow guiding unit plate 5 includes a first baffle 51 connected in sequence. The first baffle 51 includes a first flow guiding plate 52 and a first arc transition plate 53 connected to the first flow guiding plate 52. For two adjacent first flow guiding unit plates 5, the first flow guiding plate 52 of one first flow guiding unit plate 5 is connected to the first arc transition plate 53 of the other first flow guiding unit plate 5;

[0127] The second flow guiding unit plate 6 includes a second baffle 61 connected in sequence. The second baffle 61 includes a second flow guiding plate 62 and a second arc transition plate 63 connected to the second flow guiding plate 62. For two adjacent second flow guiding unit plates 6, the second flow guiding plate 62 of one second flow guiding unit plate 6 is connected to the second arc transition plate 63 of the other second flow guiding unit plate 6;

[0128] The first bump 7 is arranged on the inner wall of the channel 3 of each first flow guiding unit plate 5. Between the first bump 7 and the corresponding first flow guiding plate 52, a first side channel 11 is formed. Between the first bump 7 and the corresponding first arc transition plate 53, a first arc transition channel 12 is formed. Between the first bump 7 and the corresponding second flow guiding plate 62, a first main channel 13 is formed. The first side channel 11 communicates with the first main channel 13, and the first arc transition channel 12 communicates with the first side channel 11 and the first main channel 13 to form a first branch channel 14 arranged in a closed loop;

[0129] The second bump 8 is arranged on the inner wall of the channel 3 of each second flow guiding unit plate 6. Between the second bump 8 and the corresponding second flow guiding plate 62, a second side channel 15 is formed. Between the second bump 8 and the corresponding second arc transition plate 63, a second arc transition channel 16 is formed. Between the second bump 8 and the corresponding first flow guiding plate 52, a second main channel 17 is formed. The second side channel 15 communicates with the second main channel 17, and the second arc transition channel 16 communicates with the second side channel 15 and the second main channel 17 to form a second branch channel 18 arranged in a closed loop;

[0130] The adjacent second main channel 17 and first main channel 13 are connected in sequence to form a main channel 9. In order to show the main channel 9, the main channel 9 is represented by a black dotted line in Figure 6 The main channel 9 in Figure 6 is represented by a black dotted line; Figure 7 、 Figure 8 、 Figure 9 、 Figure 11 、 Figure 12 and Figure 13 The main channel 9 in Figure 6 is the same as the main channel 9 represented by the black dotted line in Figure 7 、 Figure 8 、 Figure 9 、 Figure 11 、 Figure 12 and Figure 13The main channel 9 is omitted and not marked;

[0131] The first branch channel 14 and the second branch channel 18 are distributed on both sides of the main channel 9 along the extension direction of the main channel 9 and are arranged in a staggered manner.

[0132] The Tesla valve structure 4 of the present application has two forms, which will be introduced separately below:

[0133] The first form: As shown in Figure 7 , Figure 8 and Figure 9 , the first deflector 52 is a straight first deflector 521, the first bump 7 is a rectangular first bump 71, the length direction of the rectangular first bump 71 is the same as the length direction of the straight first deflector 521, and a first side channel 11 formed between the rectangular first bump 71 and the straight first deflector 521 is a straight first side channel 111;

[0134] One end of the rectangular first bump 71 is an arc end 19, and a first arc transition channel 12 formed between the arc end 19 and the first arc transition plate 53 is a semi-circular first arc transition channel 121;

[0135] The second deflector 62 is a straight second deflector 621, the second bump 8 is a rectangular second bump 81, the length direction of the rectangular second bump 81 is the same as the length direction of the straight second deflector 621, and a second side channel 15 formed between the rectangular second bump 81 and the straight second deflector 621 is a straight second side channel 151;

[0136] One end of the rectangular second bump 81 is an arc end 19, and a second arc transition channel 16 formed between the arc end 19 and the second arc transition plate 63 is a semi-circular second arc transition channel 161;

[0137] The other end of the rectangular first bump 71 is a pointed end 20, and a first main channel 13 formed between the inclined surface 201 of the pointed end 20 and the corresponding straight second deflector 621 is a straight first main channel 131;

[0138] The other end of the rectangular second bump 81 is a pointed end 20, and a second main channel 17 formed between the inclined surface 201 of the pointed end 20 and the corresponding straight first deflector 521 is a straight second main channel 171;

[0139] The adjacent straight second main channel 171 and straight first main channel 131 are connected in sequence to form the main channel 9.

[0140] Specifically, on the inner wall of the channel 3 near the inflow end 21, an inflow end transition plate 23 is provided. The inflow end transition plate 23 is connected to the adjacent first arc transition plate 53. Between the inflow end transition plate 23 and the corresponding linear second deflector 621, a liquid inlet transition channel 24 is formed. The liquid inlet transition channel 24 is communicated with the main channel 9, and the inflow hole 211 is communicated with the liquid inlet transition channel 24.

[0141] On the inner wall of the channel 3 near the outflow end 22, an outflow end transition plate 25 is provided. The outflow end transition plate 25 is connected to the adjacent linear first deflector 521. Between the outflow end transition plate 25 and the corresponding linear second deflector 621, a liquid outlet transition channel 26 is formed. The liquid outlet transition channel 26 is communicated with the main channel 9, and the outflow hole 221 is communicated with the liquid outlet transition channel 26.

[0142] Through the setting of the liquid inlet transition channel 24, the fluid can enter the main channel 9 from the inflow end 21 more smoothly through the liquid inlet transition channel 24.

[0143] Through the setting of the liquid outlet transition channel 26, the fluid entering the main channel 9 can flow out more smoothly through the liquid outlet transition channel 26.

[0144] Combined with the above-mentioned first Tesla valve structure 4 of the present application, referring to Figure 7 and Figure 8 , for the convenience of description, Figure 7 and Figure 8 the black solid arrows in indicate the flow directions of the fluids in the linear first main channel 131 and the linear second main channel 171. Figure 7 and Figure 8The black dashed arrows in it indicate the flow directions of the fluids in the first branch channel 14 and the second branch channel 18. When the fluid flows in from the low-resistance direction of the Tesla valve structure 4 (i.e., the inflow end 21 of the elastic valve prosthesis 2), the fluid entering the straight first main channel 131 is split into two parts under the diversion of the rectangular first bump 71. One part of the fluid enters the first branch channel 14, and the other part of the fluid continues to flow along the straight first main channel 131. Due to the existence of the semi-circular first arc transition channel 121, there is a certain resistance for the fluid to enter the first branch channel 14 through the semi-circular first arc transition channel 121. Therefore, only a small part of the fluid in the straight first main channel 131 can enter the first branch channel 14 through the semi-circular first arc transition channel 121. The fluid entering the first branch channel 14 re-enters the straight first main channel 131 through the straight first side channel 111 and merges with the fluid in the straight first main channel 131 again. During the merging process, since the component of the flow direction of the fluid in the straight first side channel 111 is consistent with the flow direction of the fluid in the straight first main channel 131, there is not much obstruction when the fluid in the straight first side channel 111 merges with the fluid in the straight first main channel 131, and there is almost no energy loss of the fluid.

[0145] After the fluid in the straight first side channel 111 merges with the fluid in the straight first main channel 131, it enters the straight second main channel 171. The fluid entering the straight second main channel 171 is split into two parts under the diversion of the rectangular second bump 81. One part of the fluid enters the second branch channel 18, and the other part of the fluid continues to flow along the straight second main channel 171. Due to the existence of the semi-circular second arc transition channel 161, there is a certain resistance for the fluid to enter the second branch channel 18 through the semi-circular second arc transition channel 161. Therefore, only a small part of the fluid in the straight second main channel 171 can enter the second branch channel 18 through the semi-circular second arc transition channel 161. The fluid entering the second branch channel 18 re-enters the straight second main channel 171 through the straight second side channel 151 and merges with the fluid in the straight second main channel 171 again. During the merging process, the component of the flow direction of the fluid in the straight second side channel 151 is consistent with the flow direction of the fluid in the straight second main channel 171. Therefore, there is not much obstruction when the fluid in the straight second side channel 151 merges with the fluid in the straight second main channel 171, and there is almost no energy loss of the fluid.

[0146] The fluid advances alternately and repeatedly according to the above rules, and finally enables the fluid entering from the inflow end 21 of the elastic valve prosthesis 2 to flow out smoothly from the outflow end 22 of the elastic valve prosthesis 2.

[0147] Reference Figure 9 , for ease of description, Figure 9 the black solid arrows in [reference] indicate the flow directions of the fluid in the linear first main channel 131 and the linear second main channel 171, Figure 9 the black dashed arrows in [reference] indicate the flow directions of the fluid in the first branch channel 14 and the second branch channel 18. When the fluid flows in from the high-resistance direction of the Tesla valve structure 4 (i.e., the outflow end 22 of the elastic valve prosthesis 2), the fluid entering the linear second main channel 171 is split into two parts under the diversion of the rectangular second bump 81. One part of the fluid enters the second branch channel 18 through the linear second side channel 151, and the other part of the fluid continues to flow along the linear second main channel 171. The fluid entering the second branch channel 18 re-enters the linear second main channel 171 after passing through the semi-circular second arc transition channel 161. Due to the existence of the semi-circular second arc transition channel 161, when the fluid in the linear second side channel 151 enters the semi-circular second arc transition channel 161, it will collide with the inner wall of the second arc transition plate 63, thereby losing a considerable amount of energy. Moreover, the semi-circular second arc transition channel 161 will adjust the flow direction of the fluid in the linear second side channel 151, so that the component of the flow direction of the fluid re-entering the linear second main channel 171 after passing through the semi-circular second arc transition channel 161 is opposite to the flow direction of the fluid in the linear second main channel 171. Therefore, during the confluence of the fluids, the energies of the fluids will cancel each other out.

[0148] After the fluid in the second branch channel 18 merges with the fluid in the linear second main channel 171, it enters the linear first main channel 131. The fluid entering the linear first main channel 131 is split into two parts under the diversion of the rectangular first bump 71. One part of the fluid enters the first branch channel 14 through the linear first side channel 111, and the other part of the fluid continues to flow along the linear first main channel 131. The fluid entering the first branch channel 14 re-enters the linear first main channel 131 through the semi-circular first arc transition channel 121. Due to the existence of the semi-circular first arc transition channel 121, when the fluid in the linear first side channel 111 enters the semi-circular first arc transition channel 121, the fluid in the linear first side channel 111 will collide with the inner wall of the first arc transition plate 53, resulting in a considerable loss of energy. Moreover, the semi-circular first arc transition channel 121 will adjust the flow direction of the fluid in the linear first side channel 111, so that the component of the flow direction of the fluid re-entering the linear first main channel 131 through the semi-circular first arc transition channel 121 is opposite to the flow direction of the fluid in the linear first main channel 131. Therefore, during the confluence of the fluids, the fluid energies cancel each other out.

[0149] The fluid advances alternately and repeatedly according to the above rules, and finally the fluid entering from the outflow end 22 of the elastic valve prosthesis 2 cannot flow out from the inflow end 21 of the elastic valve prosthesis 2.

[0150] It should be noted that for the above first type of Tesla valve structure 4, when the fluid flows in from the high-resistance direction of the Tesla valve structure 4 (i.e., the outflow end 22 of the elastic valve prosthesis 2), the more the number of the second branch channel 18 and the first branch channel 14 that the fluid alternately passes through, the less the remaining energy of the fluid in the main channel 9, and the greater the resistance for the fluid to flow along the main channel 9.

[0151] In summary, under the action of the above Tesla valve structure 4, unidirectional conduction from the inflow end 21 to the outflow end 22 of the elastic valve prosthesis 2 is achieved. Thus, through the unidirectional-conducting Tesla valve structure 4, the fluid can flow in the correct direction and fluid reflux can be prevented.

[0152] Preferably, as Figure 10 shown, the included angle between the inflow end transition plate 23 and the first arc transition plate 53 is defined as α, and 30° ≤ α ≤ 60°, so as to ensure the normal flow of the fluid in the Tesla valve structure 4.

[0153] The second form: as Figure 11 、 Figure 12 and Figure 13As shown, the first deflector 52 is an arc-shaped first deflector 522, the first bump 7 is an arc-shaped first bump 72, and the outer convex arc surface 27 of the arc-shaped first bump 72 can cover the arc-shaped first deflector 522 and the first arc transition plate 53. A first side channel 11 formed between the arc-shaped first bump 72 and the arc-shaped first deflector 522 is an arc-shaped first side channel 112;

[0154] A first arc transition channel 12 formed between the arc-shaped first bump 72 and the first arc transition plate 53 is a semi-circular first arc transition channel 121;

[0155] The second deflector 62 is an arc-shaped second deflector 622, the second bump 8 is an arc-shaped second bump 82, and the outer convex arc surface 27 of the arc-shaped second bump 82 can cover the arc-shaped second deflector 622 and the second arc transition plate 63. A second side channel 15 formed between the arc-shaped second bump 82 and the arc-shaped second deflector 622 is an arc-shaped second side channel 152;

[0156] A second arc transition channel 16 formed between the arc-shaped second bump 82 and the second arc transition plate 63 is a semi-circular second arc transition channel 161;

[0157] The surface of the arc-shaped first bump 72 corresponding to the arc-shaped second deflector 622 is an inner concave arc surface 33. A first main channel 13 formed between the inner concave arc surface 33 and the arc-shaped second deflector 622 is an arc-shaped first main channel 132;

[0158] The surface of the arc-shaped second bump 82 corresponding to the arc-shaped first deflector 522 is an inner concave arc surface 33. A second main channel 17 formed between this inner concave arc surface 33 and the arc-shaped first deflector 522 is an arc-shaped second main channel 172;

[0159] The adjacent arc-shaped second main channel 172 and arc-shaped first main channel 132 are connected in sequence to form the main channel 9.

[0160] Specifically, on the inner wall of the channel 3 near the inflow end 21, an inflow end transition plate 23 is provided. The inflow end transition plate 23 is connected to the adjacent arc-shaped first deflector 522. An inlet liquid transition channel 24 is formed between the inflow end transition plate 23 and the corresponding second arc transition plate 63. The inlet liquid transition channel 24 is communicated with the main channel 9, and the inflow hole 211 is communicated with the inlet liquid transition channel 24;

[0161] On the inner wall of the channel 3 near the outflow end 22, an outflow end transition plate 25 is provided. The outflow end transition plate 25 is connected to the adjacent second arc transition plate 63. An outlet liquid transition channel 26 is formed between the outflow end transition plate 25 and the corresponding arc-shaped first deflector 522. The outlet liquid transition channel 26 is communicated with the main channel 9, and the outflow hole 221 is communicated with the outlet liquid transition channel 26.

[0162] Through the provision of the liquid inlet transition channel 24, the fluid can enter the main channel 9 from the inflow end 21 more smoothly through the liquid inlet transition channel 24.

[0163] Through the provision of the liquid outlet transition channel 26, the fluid entering the main channel 9 can flow out more smoothly through the liquid outlet transition channel 26.

[0164] Combined with the above-mentioned second Tesla valve structure 4 of the present application, with reference to Figure 11 、 Figure 12 For the sake of convenience of description, Figure 11 、 Figure 12 The black solid arrows in Figure 11 、 Figure 12 represent the flow directions of the fluids in the arc-shaped first main channel 132 and the arc-shaped second main channel 172, and the black dashed arrows in Figure 11 、 Figure 12 represent the flow directions of the fluids in the first branch channel 14 and the second branch channel 18. When the fluid flows in from the low-resistance direction of the Tesla valve structure 4 (i.e., the inflow end 21 of the elastic valve prosthesis 2), the fluid entering the arc-shaped second main channel 172 is split into two parts under the diversion of the arc-shaped second bump 82. One part of the fluid enters the second branch channel 18 through the semi-circular second arc transition channel 161, and the other part of the fluid continues to flow along the arc-shaped second main channel 172. Due to the existence of the semi-circular second arc transition channel 161, there is a certain resistance for the fluid to enter the second branch channel 18 through the semi-circular second arc transition channel 161. Therefore, only a small part of the fluid in the arc-shaped second main channel 172 can enter the second branch channel 18 through the semi-circular second arc transition channel 161. The fluid entering the second branch channel 18 flows through the arc-shaped second side channel 152 and re-enters the arc-shaped second main channel 172 to re-converge with the fluid in the arc-shaped second main channel 172. During the convergence process, since the component of the flow direction of the fluid in the arc-shaped second side channel 152 is consistent with the flow direction of the fluid in the arc-shaped second main channel 172, there is not much hindrance during the convergence of the fluid in the arc-shaped second side channel 152 and the fluid in the arc-shaped second main channel 172, and there is almost no energy loss of the fluid.

[0165] After the fluid in the arc-shaped second side channel 152 and the fluid in the arc-shaped second main channel 172 converge, they enter the arc-shaped first main channel 132. The fluid entering the arc-shaped first main channel 132 is split into two parts under the diversion of the arc-shaped first bump 72. One part of the fluid enters the first branch channel 14 through the semi-circular first arc transition channel 121, and the other part of the fluid continues to flow along the arc-shaped first main channel 132. Due to the existence of the semi-circular first arc transition channel 121, there is a certain resistance for the fluid to enter the first branch channel 14 through the semi-circular first arc transition channel 121. Therefore, only a small part of the fluid in the arc-shaped first main channel 132 can enter the first branch channel 14 through the semi-circular first arc transition channel 121. The fluid entering the first branch channel 14 re-enters the arc-shaped first main channel 132 through the arc-shaped first side channel 112 and converges with the fluid in the arc-shaped first main channel 132 again. During the convergence process, due to the component of the flow direction of the fluid in the arc-shaped first side channel 112 being consistent with the flow direction of the fluid in the arc-shaped first main channel 132, there is not much obstruction during the convergence of the fluid in the arc-shaped first side channel 112 and the fluid in the arc-shaped first main channel 132, and there is almost no energy loss of the fluid.

[0166] The fluid moves forward alternately and repeatedly according to the above rules, and finally enables the fluid entering from the inlet end 21 of the elastic valve prosthesis 2 to flow out smoothly from the outlet end 22 of the elastic valve prosthesis 2.

[0167] Reference Figure 13 , for the convenience of description, Figure 13 the black solid arrows in Figure 13The black dashed arrows in it indicate the flow directions of the fluids in the first branch channel 14 and the second branch channel 18. When the fluid flows in from the high-resistance direction of the Tesla valve structure 4 (i.e., the outflow end 22 of the elastic valve prosthesis 2), the fluid entering the arc-shaped first main channel 132 is split into two parts under the diversion of the arc-shaped first bump 72. One part of the fluid enters the first branch channel 14 through the arc-shaped first side channel 112, and the other part of the fluid continues to flow along the arc-shaped first main channel 132. The fluid entering the first branch channel 14 re-enters the arc-shaped first main channel 132 through the semi-circular first arc transition channel 121. Due to the existence of the semi-circular first arc transition channel 121, when the fluid in the arc-shaped first side channel 112 enters the semi-circular first arc transition channel 121, it will collide with the inner wall of the first arc transition plate 53, thereby losing a considerable amount of energy. Moreover, the semi-circular first arc transition channel 121 will adjust the flow direction of the fluid in the arc-shaped first side channel 112, so that the component of the flow direction of the fluid re-entering the arc-shaped first main channel 132 through the semi-circular first arc transition channel 121 is opposite to the flow direction of the fluid in the arc-shaped first main channel 132. Therefore, during the confluence of the fluids, the energies of the fluids will cancel each other out.

[0168] After the fluid in the first branch channel 14 and the fluid in the arc-shaped first main channel 132 converge, they enter the arc-shaped second main channel 172. The fluid entering the arc-shaped second main channel 172 is split into two parts under the diversion of the arc-shaped second bump 82. One part of the fluid enters the second branch channel 18 through the arc-shaped second side channel 152, and the other part of the fluid continues to flow along the arc-shaped second main channel 172. The fluid entering the second branch channel 18 re-enters the arc-shaped second main channel 172 through the semi-circular second arc transition channel 161. Due to the existence of the semi-circular second arc transition channel 161, when the fluid in the arc-shaped second side channel 152 enters the semi-circular second arc transition channel 161, the fluid in the arc-shaped second side channel 152 will collide with the inner wall of the second arc transition plate 63, thereby losing a considerable amount of energy. Moreover, the semi-circular second arc transition channel 161 will adjust the flow direction of the fluid in the arc-shaped second side channel 152, so that the component of the flow direction of the fluid re-entering the arc-shaped second main channel 172 through the semi-circular second arc transition channel 161 is opposite to the flow direction of the fluid in the arc-shaped second main channel 172. Therefore, during the confluence of the fluids, the fluid energies cancel each other out.

[0169] The fluid advances alternately and repeatedly according to the above rules, and finally, the fluid entering from the outflow end 22 of the elastic valve prosthesis 2 cannot flow out from the inflow end 21 of the elastic valve prosthesis 2.

[0170] It should be noted that for the above-mentioned second Tesla valve structure 4, when the fluid flows in from the high-resistance direction of the Tesla valve structure 4 (i.e., the outflow end 22 of the elastic valve prosthesis 2), the more the number of the first branch channels 14 and the second branch channels 18 that the fluid alternately passes through, the less the remaining energy of the fluid in the main channel 9, and the greater the resistance for the fluid to flow along the main channel 9.

[0171] In summary, under the action of the above-mentioned Tesla valve structure 4, unidirectional conduction from the inflow end 21 to the outflow end 22 of the elastic valve prosthesis 2 is achieved. Thus, through the unidirectional-conducting Tesla valve structure 4, the fluid flows in the correct direction and fluid backflow can be prevented.

[0172] Preferably, as Figure 14 shown, one of the included angles between the convex arc surface 27 and the concave arc surface 33 of the arc-shaped first convex block 72 is defined as β, 30° ≤ β ≤ 60°, and the other included angle is defined as γ, 110° ≤ γ ≤ 150°. In this way, the normal flow of the fluid in the Tesla valve structure 4 is ensured.

[0173] Preferably, as Figure 15 shown, one of the included angles between the convex arc surface 27 and the concave arc surface 33 of the arc-shaped second convex block 82 is defined as β, 30° ≤ β ≤ 60°, and the other included angle is defined as γ, 110° ≤ γ ≤ 150°. In this way, the normal flow of the fluid in the Tesla valve structure 4 is ensured.

[0174] Specifically, referring to Figure 6 、 Figure 11 shown, an inflow end tapered surface 212 is provided on the pore wall of the inflow hole 211, and the inflow hole 211 is communicated with the liquid inlet transition channel 24 through the inflow end tapered surface 212;

[0175] An outflow end tapered surface 222 is provided on the pore wall of the outflow hole 221, and the outflow hole 221 is communicated with the liquid outlet transition channel 26 through the outflow end tapered surface 222;

[0176] An inflow end tapered surface 212 is provided in the inflow hole 211, and an outflow end tapered surface 222 is provided in the outflow hole 221. Thus, it can be smoother for the fluid to enter the liquid inlet transition channel 24 or for the fluid to flow out from the liquid outlet transition channel 26.

[0177] Specifically, an optimized hole 30 is provided inside the elastic valve prosthesis 2. For the present application, the optimized holes 30 are arranged on the elastic valve prosthesis 2, the first bump 7, and the second bump 8;

[0178] Along the circumferential direction of the elastic valve prosthesis 2, the inside of the elastic valve prosthesis 2 on both sides of the channel 3 is a hollow structure 31.

[0179] Through the optimized holes 30 and the hollow structure 31, it is used to reduce the weight of the expandable artificial valve prosthesis of the present application and achieve better compliance performance.

[0180] For the expandable artificial valve prosthesis of the present application, since there are no valve leaflets, therefore, the lengths and diameters of the first valve frame 39 and the second valve frame 40, and the lengths and diameters of the elastic valve prosthesis 2 can all be set flexibly, which can meet the requirements of different patients for the size of the expandable artificial valve prosthesis.

[0181] It should be noted that: the fluid mentioned in the present application includes blood.

[0182] In the actual use process of the artificial valve prosthesis of the present application, according to the actual use requirements of the patient, by changing the number of channels 3 and cooperating with the Tesla valve structure 4 in each channel 3, finally, the fluid flow rate passing through the expandable artificial valve prosthesis of the present application can reach the required flow rate value, which can meet the use needs of different patients. Therefore, the expandable artificial valve prosthesis of the present application has a wider application range.

[0183] As Figure 16 shown, an expandable artificial valve prosthesis with three channels 3 inside the valve body 38 is shown. The three channels 3 are evenly distributed along the circumferential direction of the valve body 38, and the inside of the valve body 38 between two adjacent channels 3 is a hollow structure 31. Optimized holes 30 are also provided inside the valve body 38.

[0184] Finally, it should be noted that: the above embodiments are only used to illustrate the technical solutions of the present patent, rather than to limit it; although the present patent has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present patent.

Claims

1. An expandable artificial valve prosthesis, characterized in that: It includes an elastic valve prosthesis, a transition layer, an elastic sealing body, and a valve frame; The elastic valve prosthesis is provided with a channel inside, the channel runs through the elastic valve prosthesis, and each channel is provided with a Tesla valve structure; wherein, Along the length direction of the channel, from the inflow end to the outflow end of the elastic valve prosthesis is the low resistance direction of the Tesla valve structure, and from the outflow end to the inflow end of the elastic valve prosthesis is the high resistance direction of the Tesla valve structure; An instrument guide hole is provided inside the elastic valve prosthesis, and the instrument guide hole can communicate with the inflow end and the outflow end; An elastic sealing body for closing the instrument guide hole is disposed on the end surface of the inflow end and the end surface of the outflow end. A disconnecting portion is disposed on the elastic sealing body. The disconnecting portion is in a normally closed state under the elastic force of the elastic sealing body to close the instrument guide hole. A transition layer is circumferentially arranged on the outer wall of the elastic valve prosthesis, and the transition layer has plasticity; The valve frame is respectively arranged at the inflow end and the outflow end, and the valve frame is connected to the transition layer, or the valve frame is directly fixedly connected to the elastic valve prosthesis.

2. The expandable artificial valve prosthesis according to claim 1, characterized in that: There are multiple channels, and the multiple channels are distributed along the circumference of the elastic valve prosthesis. The instrument guide hole is arranged on the inner side of the multiple channels distributed in the circumferential direction, and the instrument guide hole is coaxially arranged with the elastic valve prosthesis.

3. The expandable artificial valve prosthesis according to claim 1, characterized in that: The elastic valve prosthesis comprises a valve body and an inflow end connection part and an outflow end connection part arranged at two ends of the valve body; The inflow end connection portion and the valve body form an inflow hole, and the inflow hole is communicated with the channel; The outflow end connecting portion and the valve body form an outflow hole, and the outflow hole is communicated with the channel; The valve body is provided with the channel inside; The instrument guide hole is arranged inside the valve body; The transition layer is circumferentially arranged on the outer wall of the valve body; The valve frame includes a first valve frame and a second valve frame; A transition layer is also provided on the outer wall of the inflow end connection part, and the first flap frame is connected to the transition layer on the inflow end connection part; a transition layer is also provided on the outer wall of the outflow end connection part, and the second flap frame is connected to the transition layer on the outflow end connection part; or, The first flap frame is directly and fixedly connected to the inflow end connection portion, and the second flap frame is directly and fixedly connected to the outflow end connection portion.

4. The expandable artificial valve prosthesis according to claim 1, characterized in that: The elastic sealing body comprises a hollow plug body, an end cover is arranged on the end surface of the hollow plug body close to the inflow end, and the disconnecting portion is arranged on the end cover; The hollow plug body is respectively embedded on the end surface of the inflow end and the end surface of the outflow end.

5. The expandable artificial valve prosthesis according to claim 1, characterized in that: The Tesla valve structure includes a first guide unit plate, a second guide unit plate, a first protrusion and a second protrusion; The first guide unit plate and the second guide unit plate are arranged on the inner wall of the channel opposite to each other; A plurality of first protrusions are provided on the inner wall of the channel on the inner side of the first guide unit plate; A plurality of second protrusions are provided on the inner wall of the channel on the inner side of the second guide unit plate; The plurality of first protrusions and the second protrusions are arranged in cooperation with the first guide unit plate and the second guide unit plate to form the Tesla valve structure, so as to form a main channel and a plurality of branch channels connected to the main channel in the channel.

6. The expandable artificial valve prosthesis according to claim 5, characterized in that: The first guide unit plate includes first baffles connected in sequence, the first baffle includes a first guide plate and a first arc transition plate connected to the first guide plate, and the first guide plate of one of the two adjacent first guide unit plates is connected to the first arc transition plate of the other first guide unit plate; The second guide unit plate comprises second baffles connected in sequence, the second baffle comprises a second guide plate and a second arc transition plate connected to the second guide plate, and the second guide plate of one of the two adjacent second guide unit plates is connected to the second arc transition plate of the other second guide unit plate; The first protrusion is arranged on the inner wall of the channel inside each first guide unit plate, a first side channel is formed between the first protrusion and the corresponding first guide plate, a first arc transition channel is formed between the first protrusion and the corresponding first arc transition plate, a first main channel is formed between the first protrusion and the corresponding second guide plate, the first side channel is connected to the first main channel, and the first arc transition channel is connected to the first side channel and the first main channel to form a first branch channel arranged in a closed loop; The second protrusion is arranged on the inner wall of the channel inside each second guide unit plate, a second side channel is formed between the second protrusion and the corresponding second guide plate, a second arc transition channel is formed between the second protrusion and the corresponding second arc transition plate, a second main channel is formed between the second protrusion and the corresponding first guide plate, the second side channel is connected to the second main channel, and the second arc transition channel is connected to the second side channel and the second main channel to form a second branch channel arranged in a closed loop; The adjacent second main channels and the first main channels are connected in sequence to form the main channel; The first branch channel and the second branch channel are distributed on both sides of the main channel along the extension direction of the main channel and are staggered with each other.

7. The expandable artificial valve prosthesis according to claim 6, characterized in that: The first guide plate is a straight first guide plate, the first protrusion is a rectangular first protrusion, the length direction of the rectangular first protrusion is the same as the length direction of the straight first guide plate, and the first side channel formed between the rectangular first protrusion and the straight first guide plate is a straight first side channel; One end of the rectangular first protrusion is an arc end, and the first arc transition channel formed between the arc end and the first arc transition plate is a semi-annular first arc transition channel; The second guide plate is a straight second guide plate, the second protrusion is a rectangular second protrusion, the length direction of the rectangular second protrusion is the same as the length direction of the straight second guide plate, and the second side channel formed between the rectangular second protrusion and the straight second guide plate is a straight second side channel; One end of the rectangular second convex block is an arc end, and the second arc transition channel formed between the arc end and the second arc transition plate is a semi-annular second arc transition channel; The other end of the rectangular first protrusion is a pointed end, and the first main channel formed between the inclined surface of the pointed end and the corresponding straight second guide plate is a straight first main channel; The other end of the rectangular second convex block is a pointed end, and the second main channel formed between the inclined surface of the pointed end and the corresponding straight-shaped first guide plate is a straight-shaped second main channel; The adjacent straight-line second main channels and the straight-line first main channels are connected in sequence to form the main channel.

8. The expandable artificial valve prosthesis according to claim 7, characterized in that: An inlet transition plate is provided on the inner wall of the channel near the inlet end, the inlet transition plate is connected to the adjacent first arc transition plate, a liquid inlet transition channel is formed between the inlet transition plate and the corresponding second linear guide plate, and the liquid inlet transition channel is connected to the main channel; An outflow end transition plate is provided on the inner wall of the channel near the outflow end, and the outflow end transition plate is connected to the adjacent straight-shaped first guide plate. A liquid outlet transition channel is formed between the outflow end transition plate and the corresponding straight-shaped second guide plate, and the liquid outlet transition channel is connected to the main channel.

9. The expandable artificial valve prosthesis according to claim 6, characterized in that: The first guide plate is an arc-shaped first guide plate, the first protrusion is an arc-shaped first protrusion, the outer convex arc surface of the arc-shaped first protrusion can cover the arc-shaped first guide plate and the first circular arc transition plate, and the first side channel formed between the outer convex arc surface and the arc-shaped first guide plate is an arc-shaped first side channel; The first arc transition channel formed between the arc-shaped first protrusion and the first arc transition plate is a semi-annular first arc transition channel; The second guide plate is an arc-shaped second guide plate, the second protrusion is an arc-shaped second protrusion, the outer convex arc surface of the arc-shaped second protrusion can cover the arc-shaped second guide plate and the second arc transition plate, and the second side channel formed between the arc-shaped second protrusion and the arc-shaped second guide plate is an arc-shaped second side channel; The second arc transition channel formed between the arc-shaped second protrusion and the second arc transition plate is a semi-annular second arc transition channel; The surface of the arc-shaped first convex block corresponding to the arc-shaped second guide plate is an inwardly concave arc-shaped surface, and the first main channel formed between the inwardly concave arc-shaped surface and the arc-shaped second guide plate is an arc-shaped first main channel; The surface of the arc-shaped second convex block corresponding to the arc-shaped first guide plate is a concave arc-shaped surface, and the second main channel formed between the concave arc-shaped surface and the arc-shaped first guide plate is an arc-shaped second main channel; The adjacent arc-shaped second main channels and the arc-shaped first main channels are connected in sequence to form the main channel.

10. The expandable artificial valve prosthesis according to claim 9, characterized in that: An inlet transition plate is provided on the inner wall of the channel near the inlet end, the inlet transition plate is connected to the adjacent arc-shaped first guide plate, a liquid inlet transition channel is formed between the inlet transition plate and the corresponding second arc transition plate, and the liquid inlet transition channel is connected to the main channel; An outflow end transition plate is provided on the inner wall of the channel near the outflow end, and the outflow end transition plate is connected to the adjacent second arc transition plate. A liquid outlet transition channel is formed between the outflow end transition plate and the corresponding arc-shaped first guide plate, and the liquid outlet transition channel is connected to the main channel.

11. The expandable artificial valve prosthesis according to claim 1, characterized in that: The elastic valve prosthesis is provided with an optimized hole inside; Along the circumferential direction of the elastic valve prosthesis, the interior of the elastic valve prosthesis located on both sides of the channel is a hollow structure.

12. The expandable artificial valve prosthesis according to claim 3, characterized in that: An inflow end conical surface is arranged in the hole wall of the inflow hole, and the inflow hole is connected with the channel through the inflow end conical surface; An outflow end conical surface is arranged in the hole wall of the outflow hole, and the outflow hole is connected with the channel through the outflow end conical surface.

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