Artificially implanted heart valve

Abstract

The invention discloses an artificially implanted heart valve which has an axial direction, an inflow side and an outflow side in space, the artificially implanted heart valve comprises an inner frame, the inner frame is of a barrel-shaped structure which can deform in the radial direction, the inner frame is of a grid structure, and each grid is defined by frame strips; a valve leaflet; the outer frame is of an integrated annular structure and comprises a plurality of arm parts in the circumferential direction, the outflow side of each arm part is fixedly connected to the inner frame, the inflow side of each arm part is located on the periphery of the inner frame, and a first gap capable of clamping native tissue is formed between the inflow side of each arm part and the inner frame; the outflow sides of every two adjacent arm parts are close to each other to form an intersection part, each intersection part is provided with a forked structure extending towards the corresponding outflow side, and the forked structures extend along the frame strips of the inner frame. The intersection part of the artificially implanted heart valve extends to the inner side of the inner frame and is attached to the inner side of the inner frame, so that the artificially implanted heart valve is convenient to load and adjust the posture in the body in the releasing process, and operation is more convenient.

Description

[0001] This application is a divisional application of the invention entitled "Artificial Implantable Heart Valve". The original application was filed on April 26, 2023, and the original application number was 202310465493.5. Technical Field

[0002] This application relates to the field of medical device technology, and in particular to an artificial implantable heart valve. Background Technology

[0003] An artificial heart valve is an artificial organ made of artificial materials that can be implanted into the human heart to replace the aortic valve, pulmonary valve, tricuspid valve, and other heart valves, allowing blood to flow in one direction and possessing the function of a natural heart valve. Generally, existing artificial heart valves are implanted into the corresponding location via catheter, including an inner frame and an outer frame that holds the original valve leaflet. However, in current technology, the junction of the inner and outer frames creates a step on the outer periphery of the artificial heart valve, causing inconvenience or safety hazards in adjusting the valve's posture within the body during loading and deployment. Summary of the Invention

[0004] This invention provides an artificial heart valve that solves the problem that the outer peripheral surface of the artificial heart valve in the prior art has steps, which causes inconvenience or safety hazards in adjusting its posture in the body during loading and release.

[0005] An implantable heart valve, having a spatial axial direction and an inflow side and an outflow side opposite each other in the axial direction, the implantable heart valve comprising:

[0006] The inner frame is a radially deformable cylindrical structure with blood flow channels inside;

[0007] Leaflets, connected to the inner frame to alter the degree of opening of the blood flow channels;

[0008] The outer frame is an integral ring structure, which includes multiple arms in the circumferential direction. The outflow side of each arm is fixedly connected to the inner frame, and the inflow side of each arm is located on the outer periphery of the inner frame and forms a first gap between the inner frame and the inner frame to clamp the original tissue.

[0009] The outflow sides of two adjacent arms approach each other to form a junction, which extends radially inward from the outer side of the outer frame to the inner side of the inner frame and is fixed against the inner wall of the inner frame.

[0010] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0011] Optionally, the inner frame has a grid structure, with each grid surrounded by frame strips, and the confluence has a forked structure extending toward the outflow side.

[0012] Optionally, the bifurcated structure extends along the frame bars of the inner frame.

[0013] Optionally, the node portion of the bifurcation structure has a suture hole.

[0014] Optionally, the arm includes a root, a middle section, and a head section 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 to the head, and there is an isolation gap between the middle section and the outer periphery of the inner frame.

[0015] Optionally, the head abuts against the outer periphery of the inner frame.

[0016] Optionally, the outer frame is a frame structure, and the frame at the head has wavy undulations and anti-slip grooves on the surface.

[0017] Optionally, at least one of the two axial ends of the inner frame has a connecting lug that mates with the conveying system, and the connecting lug is an integral structure with the inner frame.

[0018] Optionally, the connecting ears are T-shaped, there are three of them, and they are evenly arranged circumferentially, with each connecting ear having a different height.

[0019] Optionally, the artificially implanted heart valve has relative characteristics according to the degree of radial deformation:

[0020] In the compressed state, both the inner frame and the outer frame are radially compressed, with the inflow side of the outer frame approaching the outer periphery of the inner frame;

[0021] In the transition state, the inflow side of the outer frame expands radially outward relative to the outer periphery of the inner frame, while at least a portion of the inner frame remains radially compressed;

[0022] In the released state, both the inner frame and the outer frame expand radially.

[0023] The confluence of the artificial heart valve in this application extends to and abuts against the inner side of the internal frame, making it easier to load the artificial heart valve and adjust its posture in the body during the release process, thus facilitating operation. Attached Figure Description

[0024] Figure 1a This is a schematic diagram of the structure of an artificially implanted heart valve in one embodiment;

[0025] Figure 1b for Figure 1a A top-view structural diagram of an artificially implanted heart valve.

[0026] Figure 2a A schematic diagram of the aorta;

[0027] Figure 2b A schematic diagram of an artificial heart valve implanted in the aorta;

[0028] Figure 2c This is a schematic diagram of the conveying system.

[0029] Figure 3a A schematic diagram of an artificially implanted heart valve in a compressed state;

[0030] Figure 3b A schematic diagram of the structure of an artificially implanted heart valve in a transitional state;

[0031] Figure 3c This is a schematic diagram of an artificially implanted heart valve with a connecting ear in one embodiment;

[0032] Figure 4a This is a schematic diagram of the structure of an artificially implanted heart valve in one embodiment;

[0033] Figure 4b for Figure 4a A schematic diagram of the scaffolding structure;

[0034] Figure 4c for Figure 4a Schematic diagram of the inner frame;

[0035] Figure 4d for Figure 4a A schematic diagram of the structure in which the inner frame and outer frame work together;

[0036] The annotations in the figure are explained as follows:

[0037] 600. Aorta; 601. Original leaflet; 602. Valvular sinus;

[0038] 700. Artificial implanted heart valve; 701. Stent; 703. Connecting ear; 710. Leaflet; 720. Inner frame; 750. Outer frame; 751. First space; 752. Union; 753. Arm; 7531. Root; 7532. Middle; 7533. Head; 7534. Anti-slip groove; 754. Isolation gap; 755. Suture hole;

[0039] 800, Catheter assembly; 801, Proximal end; 802, Distal end; 803, Loading section; 808, Control handle. Detailed Implementation

[0040] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0041] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0042] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0043] In this application, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number or order of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0044] refer to Figures 1a to 2c The artificial implantable heart valve 700 in this application generally includes a deformable stent 701 and a leaflet 710 connected within the stent 701. The stent 701 is cylindrical in shape with a hollowed-out mesh structure on the side wall, including an inner frame 720 and an outer frame 750. The outer frame 750 mainly serves as a positioning structure. In order to prevent leakage, a skirt or anti-leakage material can be provided on the inner and / or outer sides of the inner frame 720.

[0045] Depending on the release mode, the stent 701 is made of a different material, such as a nickel-titanium alloy with shape memory that can expand internally, or stainless steel that can be released by ball expansion. The stent 701 itself can be formed by cutting tubes or weaving wires. The leaflets 710 can be connected to the stent 701 by stitching, bonding or integral molding.

[0046] To facilitate understanding and demonstrate the structural features of the product of this application, the following embodiments all take the aortic 600 intervention as an example. The aortic 600 valve has three native leaflets 601. Each native leaflet 601 is separated from the surrounding vascular wall by a valve sinus 602. According to the normal blood flow direction, the artificially implanted heart valve 700 has a spatial axial direction and an inflow side and an outflow side that are opposite each other in the axial direction. X1 is the inflow side, X2 is the outflow side, and the arrow direction is the blood flow direction.

[0047] In one embodiment of this application, the artificial heart valve 700 includes an inner frame 720, leaflets 710, and an outer frame 750. The outer frame 750 can be located in each valve sinus 602 in the body. The inner frame 720 and the outer frame 750 accommodate the original leaflets 601 and can also abut against the bottom of the valve sinus 602, playing a role in axial and circumferential positioning, preventing the artificial heart valve 700 from shifting position under the action of blood flow.

[0048] The inner frame 720 is a radially deformable cylindrical structure with a blood flow channel inside; the leaflet 710 is connected to the inner frame 720 to change the opening degree of the blood flow channel; the outer frame 750 is an integral annular structure, including multiple arms 753 in the circumferential direction. The outflow side of each arm 753 is fixedly connected to the inner frame 720, and the inflow side of each arm 753 is located on the outer periphery of the inner frame 720 and forms a first gap 751 between it and the inner frame 720 to hold the original tissue. In this embodiment, the original tissue specifically refers to the original leaflet 601.

[0049] The leaflet 710 comprises multiple pieces that cooperate with each other, and the number and circumferential position of each arm 753 match the corresponding leaflet 710. In this embodiment, there are three leaflets 710 and three arms 753. The leaflets 710 are made of biomaterials or polymer materials.

[0050] The outer frame 750 is an integral ring structure that can be molded as a single piece during processing, which not only ensures the support strength but also simplifies the assembly with the inner frame 720 to some extent.

[0051] During surgery, a delivery system is generally used to deliver and operate interventional instruments. The delivery system generally includes a control handle 808 and a catheter assembly 800. The catheter assembly 800 includes multiple control handles. The catheter assembly 800 or the entire delivery system has a proximal end 801 close to the operator and a corresponding distal end 802. The distal ends 802 of each control handle cooperate with each other to operate the interventional instruments.

[0052] refer to Figures 3a-3b The artificial heart valve 700 is delivered to a designated location or retrieved via the catheter assembly 800. The artificial heart valve 700, according to the degree of radial deformation, has the following relative characteristics:

[0053] In the compressed state, both the inner frame 720 and the outer frame 750 are radially compressed, with the inflow side of the outer frame 750 approaching the outer periphery of the inner frame 720;

[0054] In the transition state, the inflow side of the outer frame 750 expands radially outward relative to the outer periphery of the inner frame 720, while at least a portion of the inner frame 720 remains radially compressed. At this time, a gap can be formed between the outer frame 750 and the outer wall of the inner frame 720 for the original leaflet 601 to enter.

[0055] In the released state, both the inner frame 720 and the outer frame 750 expand radially toward a pre-heat-set shape. In the in vivo environment, at least one primary leaflet 601 is typically clamped and confined between the outer frame 750 and the inner frame 720.

[0056] In this embodiment, both the inner frame 720 and the outer frame 750 switch from the compressed state to the released state by self-expansion. In order to give full play to the positioning function of the outer frame 750, the catheter assembly 800 in the delivery system can be configured with at least two catheters, both of which have loading sections 803 at their distal ends. The openings of the two loading sections 803 are opposite each other, and when they are fastened together, they load and wrap the interventional device.

[0057] refer to Figure 3c The implantable heart valve 700 may generally have a connecting structure that mates with the catheter assembly 800. For example, at least one end of the inner frame 720 has a connecting lug 703 that mates with the delivery system. The connecting lug 703 is an integral structure with the inner frame 720 and is specifically T-shaped, capable of engaging with the catheter assembly 800 in a compressed state. Figure 3c (The remaining views are omitted as they include the connecting ear 703). In this embodiment, there are three connecting ears 703, which are evenly arranged circumferentially. However, considering the safety hazard caused by the excessive deformation of the inner frame 720 in a short time when the stent 701 is fully released, the height of each connecting ear 703 is different, so that the inner frame 720 is released in stages to avoid puncturing the blood vessel wall.

[0058] refer to Figures 4a to 4d One embodiment provides an artificial heart valve 700, including an inner frame 720, leaflets 710 and an outer frame 750. The outer frame 750 is an integral annular structure, including multiple arms 753 in the circumferential direction. The outflow side of each arm 753 is fixedly connected to the inner frame 720, and the inflow side of each arm 753 is located on the outer periphery of the inner frame 720 and forms a first gap 751 between the arm 753 and the inner frame 720 to hold the original tissue.

[0059] The outflow sides of two adjacent arm portions 753 approach each other to form a confluence portion 752. The confluence portion 752 extends radially inward from the outer side of the outer frame 750 to the inner side of the inner frame 720 and is fixed against the inner wall of the inner frame 720. When loading is required, the catheter assembly 800 gradually receives the stent 701 from the outflow side to the inflow side. Since the confluence portion 752 is fixed to the inner wall of the inner frame 720, that is, there are no protruding joints on the outer periphery of the inner frame 720 that are fixed to the outer frame 750, interference between the confluence portion 752 and the end of the loading section 803 is avoided. Similarly, this structure can also adjust the body posture in time during the release of the artificial implanted heart valve 700, making the operation easier.

[0060] The diameter of the inner frame 720 in this application gradually decreases and then gradually increases from the outflow side to the inflow side, wherein the diameter of the inflow side is smaller than the diameter of the outflow side, and the junction 752 is located in the middle position of the inner frame 720, where the diameter is the smallest.

[0061] The arm 753 includes a root 7531, a middle part 7532 and a head 7533 in sequence from the outflow side to the inflow side. In the released state, the circumferential span of the arm 753 gradually narrows from the root 7531 to the head 7533, and there is an isolation gap 754 between the middle part 7532 and the outer periphery of the inner frame 720.

[0062] The arm 753 gradually narrows from the root 7531 to the head 7533, forming an overall U-shaped frame structure. This avoids interference with the junction of the two adjacent primary leaflets 601, allowing the head 7533 to extend into and abut against the bottom of the sinus 602. The isolation gap 754 is formed by the middle part 7532 protruding outwards, absorbing the deformation of the primary leaflet 601 as much as possible in the radial direction, thus preventing excessive deformation of the primary leaflet 601 from blocking the coronary artery.

[0063] The head 7533 abuts against the outer periphery of the inner frame 720, enabling the inner frame 720 and outer frame 750 to provide a more effective clamping force in the released state. To further increase the clamping force, the head 7533 may also abut against the outer periphery of the inner frame 720 and have a pre-tightening force.

[0064] In this embodiment, the outer frame 750 is a frame structure, and the frame of the head 7533 has a wave-like undulation. The head 7533 is wrapped with a protective film, which can be made of pericardial membrane material, to prevent the outer frame 750 from puncturing blood vessels and native leaflets 601. The wave-like undulation also facilitates the fixation of the protective film to prevent slippage.

[0065] The protective film is generally fixed to the head 7533 by binding wire. In one embodiment, the frame strip surface of the head 7533 has anti-slip grooves 7534 to facilitate the positioning of the binding wire. The number of anti-slip grooves 7534 can be set according to the requirements. For example, there are two anti-slip grooves 7534 on both sides of the frame strip of the head 7533.

[0066] The inner frame 720 has a grid structure, with each grid enclosed by frame strips. The confluence 752 has a forked structure extending towards the outflow side. In this embodiment, the forked structure is specifically bifurcated, with each branch extending along the frame strips of the inner frame 720 and exhibiting a tendency to bulge at the ends, for example, forming a T-shaped structure. The nodes of the forked structure have stitching holes 755, which serve a positioning function. The inner frame 720 and the outer frame 750 are fixed together by binding thread through the stitching holes 755, and the binding thread is also wrapped and tied to sew the T-shaped structures of each branch and the ends.

[0067] The outer frame 750 is jointly fixed to the inner frame 720 through a bifurcated structure, avoiding the problem of breakage at the end connection due to concentrated stress. Furthermore, the bifurcated structure is easy to fold, avoiding the problem of difficulty in compressing and loading this part. The end of the T-shaped structure can form a "cross" with the frame strip of the inner frame 720, which is convenient for winding and binding wires.

[0068] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0069] The embodiments described above are merely examples of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. An artificially implanted heart valve, having a spatial axial direction and an inflow side and an outflow side opposite each other in the axial direction, characterized in that, The artificial implanted heart valve includes: The inner frame is a radially deformable cylindrical structure with blood flow channels inside. The inner frame has a grid structure, with each grid surrounded by frame strips. Leaflets, connected to the inner frame to alter the degree of opening of the blood flow channels; The outer frame is an integral ring structure, which includes multiple arms in the circumferential direction. The outflow side of each arm is fixedly connected to the inner frame, and the inflow side of each arm is located on the outer periphery of the inner frame and forms a first gap between the inner frame and the inner frame to clamp the original tissue. The outflow sides of two adjacent arms approach each other to form a junction, the junction having a bifurcated structure extending toward the outflow side, the bifurcated structure extending along the frame bars of the inner frame.

2. The artificial implantable heart valve according to claim 1, characterized in that, The nodes of the bifurcated structure have stitching holes, and the inner frame and outer frame are fixed to each other by binding wires passing through these stitching holes.

3. The artificial implantable heart valve according to claim 2, characterized in that, The bifurcated structure is bifurcated, with each branch extending along the inner frame and expanding at the end to form a T-shaped structure.

4. The artificial implantable heart valve according to claim 3, characterized in that, The T-shaped structure and the inner frame strips are stacked to form a cross-shaped structure, and the binding wire is wrapped around and tied to the cross-shaped structure.

5. The artificial implantable heart valve according to claim 1, characterized in that, The diameter of the inner frame gradually decreases and then gradually increases in the direction from the outflow side to the inflow side, and the confluence is located at the middle position where the inner frame diameter is the smallest.

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

7. The artificial implantable heart valve according to claim 6, characterized in that, The arm gradually narrows from the root to the head, forming a U-shaped frame structure.

8. The artificial implantable heart valve according to claim 6, characterized in that, The isolation gap is formed by the middle part of the arm protruding outwards.

9. The artificial implantable heart valve according to claim 6, characterized in that, The head of the arm abuts against the outer periphery of the inner frame and has a pre-tightening force.

10. The artificial implantable heart valve according to claim 1, characterized in that, The junction extends radially inward from the outer side of the outer frame to the inner side of the inner frame and is abutted and fixed to the inner wall of the inner frame.

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