Artificial heart valve

Abstract

The present application discloses an artificial implantable heart valve, which has an axial direction in space and an inflow side and an outflow side that are opposite to each other in the axial direction. The artificial implantable heart valve includes: an inner frame, which is a radially deformable cylindrical structure with a blood flow channel inside; valve leaflets, which are connected to the inner frame to change the opening degree of the blood flow channel; an outer frame, which is an integral annular structure by itself and includes a plurality of arm portions in the circumferential direction. The outflow sides of the respective arm portions are fixedly connected to the inner frame, and a first gap for clamping native tissue is formed between the inflow sides of the respective arm portions and the inner frame on the outer periphery of the inner frame; the outflow sides of two adjacent arm portions are close to each other to form a confluence portion, and the confluence portion extends radially inward from the outside of the outer frame to the inside of the inner frame and is attached and fixed to the inner wall of the inner frame. The confluence portion of the artificial implantable heart valve of the present application extends to the inside of the inner frame and abuts against it, so that the artificial implantable heart valve is convenient for loading and adjusting the posture in the body during the release process, and is more convenient for operation.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to an artificial implantable heart valve. Background Art

[0002] An artificial heart valve refers to an artificial organ made of artificial materials that can be implanted into the human heart to replace heart valves such as the aortic valve, pulmonary valve, and tricuspid valve, enabling one-way blood flow and having the functions of natural heart valves. Generally, existing artificial heart valves are implanted into corresponding positions through a catheter, including an inner frame and an outer frame for clamping native leaflets. However, in the prior art, a step is formed on the outer peripheral surface of the artificial heart valve at the intersection of the outer frame and the inner frame, which causes inconvenience or potential safety hazards in the loading of the artificial heart valve and the adjustment of its in-vivo posture during the release process. Summary of the Invention

[0003] The present invention provides an artificial implantable heart valve, which solves the problem in the prior art that there are steps on the outer peripheral surface of the artificial heart valve, causing inconvenience or potential safety hazards in the loading of the artificial heart valve and the adjustment of its in-vivo posture during the release process.

[0004] The artificial implantable heart valve has an axial direction in space and an inflow side and an outflow side opposite to each other in the axial direction. The artificial implantable heart valve includes:

[0005] An inner frame, which is a radially deformable cylindrical structure with a blood flow channel inside;

[0006] Leaflets, connected to the inner frame to change the opening degree of the blood flow channel;

[0007] An outer frame, which is an integral annular structure by itself. In the circumferential direction, it includes a plurality of arm parts. The outflow side of each arm part is fixedly connected to the inner frame, and the inflow side of each arm part is located on the outer periphery of the inner frame and forms a first gap for clamping native tissue with the inner frame;

[0008] The outflow sides of two adjacent arm parts are close to each other to form a junction part. The junction part extends radially inward from the outside of the outer frame to the inside of the inner frame and is attached and fixed to the inner wall of the inner frame.

[0009] The following also provides several optional ways, which are not additional limitations to the above overall solution, but only further supplements or optimizations. Without technical or logical contradictions, each optional way can be combined with the above overall solution alone, or multiple optional ways can be combined with each other.

[0010] Optionally, the inner frame has a grid structure, each grid is surrounded by frame bars, and the junction part has a bifurcated structure extending towards the outflow side.

[0011] Optionally, the bifurcated structure extends along the frame bars of the inner frame.

[0012] Optionally, the node part of the bifurcated structure is provided with suture holes.

[0013] Optionally, the arm portion sequentially includes a root portion, a middle portion, and a head portion from the outflow side to the inflow side. In the released state, the circumferential span of the arm portion gradually narrows from the root portion to the head portion, and there is an isolation gap between the middle portion and the outer periphery of the inner frame.

[0014] Optionally, the head portion abuts against the outer periphery of the inner frame.

[0015] Optionally, the outer frame is a frame bar structure, the frame bars of the head portion have undulations, and the surface has anti-slip grooves.

[0016] Optionally, at least one end of the axial two ends of the inner frame is provided with a connecting ear that cooperates with the delivery system, and the connecting ear and the inner frame are an integral structure.

[0017] Optionally, the connecting ear is T-shaped, the number is three, and they are circumferentially and evenly arranged, and the heights of the connecting ears are different from each other.

[0018] Optionally, the artificial implantable heart valve has the following relatively according to the degree of radial deformation:

[0019] Compressed state, both the inner frame and the outer frame are radially compressed, and the inflow side of the outer frame approaches the outer periphery of the inner frame;

[0020] Transition state, the inflow side of the outer frame radially expands outward relative to the outer periphery of the inner frame, and at least a part of the inner frame remains radially compressed;

[0021] Released state, both the inner frame and the outer frame are radially expanded.

[0022] The intersection part of the artificial implantable heart valve in this application extends to the inner side of the inner frame and abuts against it, so that the artificial implantable heart valve is convenient for loading and adjusting the posture in the body during the release process, and is more convenient for operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1a It is a schematic structural diagram of an artificial implantable heart valve in an embodiment;

[0024] Figure 1b For Figure 1a the schematic structural diagram of the artificial implantable heart valve from a top view angle in

[0025] Figure 2a It is a schematic structural diagram of the aorta;

[0026] Figure 2bSchematic structural diagram of an artificial implantable heart valve intervening in the aorta;

[0027] Figure 2c Schematic structural diagram of a delivery system;

[0028] Figure 3a Schematic structural diagram of an artificial implantable heart valve in a compressed state;

[0029] Figure 3b Schematic structural diagram of an artificial implantable heart valve in a transitional state;

[0030] Figure 3c Schematic structural diagram of an artificial implantable heart valve with connecting lugs in an embodiment;

[0031] Figure 4a Schematic structural diagram of an artificial implantable heart valve in an embodiment;

[0032] Figure 4b For Figure 4a Schematic diagram of the mechanism of the outer frame in China and abroad;

[0033] Figure 4c For Figure 4a Schematic structural diagram of the inner frame in the middle;

[0034] Figure 4d For Figure 4a Partial schematic structural diagram of the cooperation between the inner frame and the outer frame in the middle;

[0035] The descriptions of the reference numerals in the figure are as follows:

[0036] 600, aorta; 601, native leaflet; 602, sinus;

[0037] 700, artificial implantable heart valve; 701, stent; 703, connecting lug; 710, leaflet; 720, inner frame; 750, outer frame; 751, first gap; 752, intersection; 753, arm; 7531, root; 7532, middle; 7533, head; 7534, anti-slip groove; 754, isolation gap; 755, suture hole;

[0038] 800, catheter assembly; 801, proximal end; 802, distal end; 803, loading section; 808, control handle. Detailed implementation manners

[0039] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0040] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0041] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this application pertains. The terms used in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0042] In this application, terms such as "first", "second", etc. are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity or order of the indicated technical features. Thus, features defined with "first", "second" may explicitly or implicitly include one or more of such features. In the description of the present invention, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0043] Reference Figures 1a to 2c , the artificial implantable heart valve 700 in this application generally includes a deformable stent 701 and leaflets 710 connected within the stent 701. The stent 701 is generally cylindrical as a whole, and the side wall is a hollow grid structure, including an inner frame 720 and an outer frame 750. And the outer frame 750 mainly serves as a positioning structure. In order to prevent paravalvular leakage, a skirt or paravalvular leakage prevention material, etc. can also be provided on the inner side and / or the outer side of the inner frame 720.

[0044] According to different release modes, corresponding materials are selected during the processing of the stent 701, such as nitinol alloy with shape memory and self-expandable in vivo, or stainless steel material released by balloon dilation, etc. The stent 701 itself can be formed by cutting a pipe or braiding a wire. The leaflets 710 can be connected to the stent 701 by sewing, bonding or integral die forming.

[0045] For the convenience of understanding and showing the structural characteristics of the products of this application, in the following embodiments, the aortic intervention is taken as an example. There are three native leaflets 601 at the aortic valve 600. There are valve sinuses 602 between each native leaflet 601 and the surrounding blood vessel wall. According to the normal blood flow direction, the artificial implantable heart valve 700 has an axial direction in space and an inflow side and an outflow side opposite to each other in the axial direction. Among them, X1 is the inflow side, X2 is the outflow side, and the arrow direction is the blood flow direction.

[0046] In an embodiment of the present application, the artificial implantable heart valve 700 includes an inner frame 720, valve leaflets 710, and an outer frame 750. The outer frame 750 can be positioned in vivo at each valve sinus 602 site. The native valve leaflets 601 are accommodated through the inner frame 720 and the outer frame 750. The outer frame 750 can also abut against the bottom of the valve sinus 602 to play a role in axial and circumferential positioning, preventing the problem of position deviation of the artificial implantable heart valve 700 under the action of blood flow.

[0047] The inner frame 720 is a radially deformable cylindrical structure with a blood flow channel inside. The valve leaflets 710 are connected to the inner frame 720 to change the opening degree of the blood flow channel. The outer frame 750 itself is an integral annular structure, including a plurality of arm portions 753 in the circumferential direction. The outflow side of each arm portion 753 is fixedly connected to the inner frame 720. The inflow side of each arm portion 753 is located on the outer periphery of the inner frame 720 and forms a first gap 751 that can clamp the native tissue with the inner frame 720. In this embodiment, the native tissue specifically refers to the native valve leaflets 601.

[0048] The valve leaflets 710 include multiple pieces that cooperate with each other. The number and circumferential position of each arm portion 753 match the corresponding valve leaflets 710. In this embodiment, the number of valve leaflets 710 and arm portions 753 is three. Among them, the valve leaflets 710 are made of biological materials or polymer materials.

[0049] The outer frame 750 itself being an integral annular structure can be integrally formed during processing, which not only ensures the support strength but also simplifies the assembly with the inner frame 720 to a certain extent.

[0050] During the operation, a delivery system is generally used to deliver and operate the interventional device. The delivery system generally includes a control handle 808 and a catheter assembly 800. The catheter assembly 800 includes a plurality of controlled components. The catheter assembly 800 or the entire delivery system has a proximal end 801 close to the operator and an opposite distal end 802. The distal ends 802 of each controlled component cooperate with each other to operate the interventional device.

[0051] Reference Figures 3a to 3b , the artificial implantable heart valve 700 is delivered to a designated position or retrieved through the catheter assembly 800. According to the degree of radial deformation, the artificial implantable heart valve 700 has opposite:

[0052] Compressed state, both the inner frame 720 and the outer frame 750 are radially compressed, and the inflow side of the outer frame 750 approaches the outer periphery of the inner frame 720;

[0053] Transition state, the inflow side of the outer frame 750 radially expands outward relative to the outer periphery of the inner frame 720, and at least a part of the inner frame 720 remains radially compressed. At this time, a gap for the native valve leaflets 601 to enter can be formed between the outer frame 750 and the outer wall of the inner frame 720;

[0054] In the released state, both the inner frame 720 and the outer frame 750 expand radially towards their pre - heat - set shapes. In a body environment, generally at least one native leaflet 601 is clamped and defined between the outer frame 750 and the inner frame 720.

[0055] In this embodiment, both the inner frame 720 and the outer frame 750 are switched from the compressed state to the released state in a self - expanding manner. In order to fully exert the positioning function of the outer frame 750, the catheter assembly 800 in the delivery system can be configured with at least two distal ends each having a loading section 803, and the two loading sections 803 have opposite openings and are buckled together to load and wrap the interventional device.

[0056] Reference Figure 3c , the artificial implantable heart valve 700 generally can be provided with a connection structure that cooperates with the catheter assembly 800. For example, among the axial two ends of the inner frame 720, at least one end is provided with a connection ear 703 that cooperates with the delivery system. The connection ear 703 and the inner frame 720 are an integral structure, and specifically in a T - shape, and can be engaged with the catheter assembly 800 in the compressed state ( Figure 3c is provided with a connection ear 703, and the rest of the views are omitted). In this embodiment, the number of connection ears 703 is three and they are circumferentially and evenly arranged. Of course, considering the potential safety hazard caused by excessive short - time deformation of the inner frame 720 when the stent 701 is fully released, the heights of the connection ears 703 in this application are different from each other, so that the inner frame 720 is released in stages to avoid puncturing the blood vessel wall.

[0057] Reference Figures 4a to 4d , in one embodiment, an artificial implantable heart valve 700 is provided, including an inner frame 720, leaflets 710, and an outer frame 750. The outer frame 750 is an integral annular structure and includes a plurality of arm portions 753 in the circumferential direction. The outflow sides of the respective arm portions 753 are fixedly connected to the inner frame 720, and the inflow sides of the respective arm portions 753 are located on the outer periphery of the inner frame 720 and form a first gap 751 that can clamp native tissue with the inner frame 720.

[0058] The outflow sides of two adjacent arm portions 753 approach each other to form a junction portion 752. The junction portion 752 extends radially inward from the outside of the outer frame 750 to the inside of the inner frame 720 and is attached and fixed to the inner wall of the inner frame 720. When loading, the catheter assembly 800 gradually receives the stent 701 from the outflow side to the inflow side of the stent 701. Since the junction portion 752 is fixed to the inner wall of the inner frame 720, that is, there is no outer convex node on the outer periphery of the inner frame 720 fixed to the outer frame 750, the interference problem between the junction portion 752 and the end of the loading section 803 is avoided. Similarly, this structure can also adjust the in - vivo posture in time during the process of releasing the artificial implantable heart valve 700, making the operation more convenient.

[0059] The diameter of the inner frame 720 of this application gradually decreases from the outflow side to the inflow side and then gradually increases. The diameter of the inflow side is smaller than that of the outflow side. The intersection part 752 is located at the middle position of the inner frame 720, and the diameter at this position is the smallest.

[0060] The arm part 753 includes a root part 7531, a middle part 7532, and a head part 7533 in sequence from the outflow side to the inflow side. In the released state, the circumferential span of the arm part 753 gradually narrows from the root part 7531 to the head part 7533, and there is an isolation gap 754 between the middle part 7532 and the outer periphery of the inner frame 720.

[0061] The arm part 753 gradually narrows from the root part 7531 to the head part 7533. For example, it is a U-shaped frame structure as a whole, which can avoid interference with the joint of two adjacent native leaflets 601, facilitating the head part 7533 to extend into and abut against the bottom of the valve sinus 602. The isolation gap 754 is formed by the middle part 7532 protruding outward, and can absorb the deformation of the native leaflets 601 as much as possible in the radial direction, avoiding the blockage of the coronary artery after the excessive deformation of the native leaflets 601.

[0062] The head part 7533 abuts against the outer periphery of the inner frame 720, so as to provide a more effective clamping force between the inner frame 720 and the outer frame 750 in the released state. In order to improve the clamping force, it can also be that the head part 7533 abuts against the outer periphery of the inner frame 720 and has a pre-tightening force.

[0063] In this embodiment, the outer frame 750 is a frame bar structure. The frame bar of the head part 7533 has undulations. The head part 7533 is wrapped with a protective film. The protective film can be made of pericardium material, which can avoid the outer frame 750 from puncturing the blood vessel and the native leaflets 601. The undulations also facilitate the fixation of the protective film to prevent slipping.

[0064] The protective film is generally fixed to the head part 7533 by tying wires. In one embodiment, the surface of the frame bar of the head part 7533 has anti-slip grooves 7534, which are convenient for wire tying positioning. The number of anti-slip grooves 7534 can be set according to requirements. For example, the number of anti-slip grooves 7534 on both sides of the frame bar of the head part 7533 is 2.

[0065] The inner frame 720 has a grid structure, and each grid is surrounded by frame bars. The intersection part 752 has a bifurcated structure extending to the outflow side. In this embodiment, the bifurcated structure is specifically a bifurcated structure, and each branch extends along the frame bar of the inner frame 720 and has a tendency to expand at the end, for example, forming a T-shaped structure. The node part of the bifurcated structure has a suture hole 755, which has a positioning function. The inner frame 720 and the outer frame 750 are fixed to each other by tying wires passing through the suture hole 755, and the tying wires also wind and tie to sew each branch and the T-shaped structure at the end.

[0066] The outer frame 750 is jointly fixed to the inner frame 720 through a bifurcated structure, avoiding the problem of disconnection at the end joint caused by concentrated stress. Further, the bifurcated structure is easy to fold, avoiding the problem of difficult compression and loading at this part. Among them, the end of the T-shaped structure can form a "cross" with the frame bar of the inner frame 720, facilitating the winding of binding wires.

[0067] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, 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, it should be considered as the scope recorded in this specification. When the technical features in different embodiments are embodied in the same drawing, the drawing can be regarded as also disclosing the combined examples of the various embodiments involved.

[0068] The above-described embodiments only represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several deformations and improvements can still be made, and these all belong to the protection scope of the present application.

Claims

1. An artificial heart valve having a spatial axis and axially opposite inflow and outflow sides, characterized in that, The artificial implantable heart valve includes: An inner frame, which is a radially deformable cylindrical structure with a blood flow channel inside; Valve leaflets, connected to the inner frame to change the opening degree of the blood flow channel; An outer frame, which is an integral annular structure itself, includes a plurality of arms in the circumferential direction, the outflow sides of each arm are fixedly connected to the inner frame, and the inflow sides of each arm are located on the outer periphery of the inner frame and form a first gap for clamping native tissue with the inner frame; The outflow sides of two adjacent arms are close to each other to form a confluence part, which extends radially inward from the outside of the outer frame to the inside of the inner frame and is fixedly attached to the inner wall of the inner frame.

2. The artificial implantable heart valve according to claim 1, wherein The inner frame has a grid structure, each grid is surrounded by frame bars, and the confluence part has a bifurcated structure extending towards the outflow side.

3. The artificial implantable heart valve according to claim 2, characterized in that, The bifurcated structure extends along the frame bars of the inner frame.

4. The artificial implantable heart valve according to claim 2, characterized in that, The node part of the bifurcated structure is provided with suture holes.

5. The artificial implantable heart valve according to claim 1, characterized in that, Each arm includes a root part, a middle part and a head part in sequence from the outflow side to the inflow side. In the released state, the circumferential span of the arm gradually narrows from the root part to the head part, and there is an isolation gap between the middle part and the outer periphery of the inner frame.

6. The artificial heart valve according to claim 5, characterized in that, The head part abuts against the outer periphery of the inner frame.

7. The artificial implantable heart valve according to claim 5, wherein The outer frame is a frame bar structure, the frame bars of the head part have undulations and anti-slip grooves on the surface.

8. The artificial implantable heart valve according to claim 5, characterized in that, At least one end of the axial two ends of the inner frame is provided with a connecting ear for cooperating with the delivery system, and the connecting ear and the inner frame are of an integral structure.

9. The artificial implantable heart valve according to claim 8, characterized in that, The connecting ear is T-shaped, the number is three, and they are evenly arranged circumferentially, and the heights of each connecting ear are different.

10. The artificial implantable heart valve according to claim 1, characterized in that, The artificial implantable heart valve has relative: A compressed state, in which both the inner frame and the outer frame are radially compressed, and the inflow side of the outer frame approaches the outer periphery of the inner frame; A transition state, in which the inflow side of the outer frame expands radially outward relative to the outer periphery of the inner frame, and at least a part of the inner frame still remains radially compressed; A released state, in which both the inner frame and the outer frame are radially expanded.

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