Elastic fixed heart valve device

Abstract

The present invention belongs to the technical field of medical devices, and specifically relates to an elastically fixed heart valve device. The elastically fixed heart valve device includes: a stent mechanism having an outer frame; a plurality of anchors, which are evenly arranged on the outer peripheral surface of the outer frame along the circumferential direction, and an anchor opening facing the inflow end is formed between the anchor and the outer frame, and the anchor has an axially compressible axial elastic portion. The present invention realizes that the anchor can be preset to a relatively long length through the design of the axially compressible axial elastic portion. After the valve is implanted, it is ensured that the free end of the anchor can effectively rest against the root of the valve ring, and the anchor compresses the axial elastic portion under the action of the valve ring, so that under the action of the compressible shortening of the axial elastic portion, no large force is generated on the valve ring, thereby avoiding the puncture of the valve ring by the anchor.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an elastically fixed heart valve device. Background Art

[0002] The heart is divided into two parts, left and right, each part contains a ventricle and atrium. The ventricles and atria are separated by the ventricular septum and atrial septum. There are valves between the atria and ventricles to prevent blood from flowing back. Normal valves only allow blood to flow in one direction in the heart.

[0003] The mitral valve and tricuspid valve are located between the left and right atria and ventricles respectively, so they are also called atrioventricular (AV) valves, which can prevent backflow from the ventricles to the atria during systole. Mitral regurgitation (MR) and tricuspid regurgitation (TR) are common heart diseases. At present, the industry generally believes that mitral regurgitation has a greater impact on the function of the heart, and the problem of tricuspid regurgitation can be alleviated by treating mitral regurgitation, so mitral regurgitation has received more research. However, with a deeper understanding of heart problems, it is found that the problem of tricuspid regurgitation is not all that serious. Tricuspid regurgitation is generally caused by pulmonary hypertension, right ventricular enlargement, and dilatation of the tricuspid valve ring. After tricuspid regurgitation occurs, symptoms of right heart failure such as fatigue, ascites, edema, pain in the liver area, indigestion, and poor appetite are aggravated, and even directly lead to an increase in mortality.

[0004] Heart valve replacement is a method of treating valvular regurgitation. The heart valve stent can have barbs / anchors to capture the native leaflets. Since each person's heart is different, the barbs / anchors cannot be adapted to everyone. In clinical practice, if the barbs / anchors are too short and there is a certain gap with the physiological valve annulus, the stent can move up and down relative to the physiological valve annulus under the impact of blood flow, increasing the risk of valve slippage. The movement process can easily impact the native leaflets and cause damage. If the barbs / anchors are too long, they can easily over-squeeze the roots of the native leaflets, causing the valve annulus to rupture, thereby causing the barbs to lose their anchoring effect. Summary of the Invention

[0005] The present invention aims to solve the technical problem that the barbs / anchors used in existing heart valve stents are not compatible with the native leaflets, causing the risk of valve slippage or damaging the native leaflets. The purpose is to provide an anchor for a heart valve device and an elastically fixed heart valve device.

[0006] In order to solve the aforementioned technical problems, the first aspect of the present invention provides an anchor for a heart valve device, wherein the anchor includes a connecting end connected to the stent and a free end located outside the connecting end, and the anchor also includes an axially compressible axial elastic portion, which is located between the connecting end and the free end.

[0007] Optionally, in the aforementioned anchoring member for a heart valve device, the axial elastic portion is a curved S-shaped portion.

[0008] Optionally, in the aforementioned anchoring member for a heart valve device, the axial elastic portion is integrally formed with the anchoring member.

[0009] Optionally, in the aforementioned anchor for a heart valve device, the rod width of the axial elastic portion is 1 / 3 to 1 / 2 of the rod width of other parts of the anchor.

[0010] Optionally, in the aforementioned anchoring member for a heart valve device, both ends of the axial elastic portion are provided with pull-wire holes, the pull-wire holes allowing a pull-wire to pass through, and the axial compression of the axial elastic portion is controlled by the pull-wire.

[0011] Optionally, in the aforementioned anchor for a heart valve device, the free end of the anchor is provided with an anchoring coating.

[0012] Optionally, in the aforementioned anchoring member for a heart valve device, the anchoring coating may be a medical-grade implantable material that can promote endothelialization, such as PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene, or bovine pericardium, preferably PTFE or ePTFE;

[0013] The anchoring coating is fixed to the free end of the anchoring member by winding and heat treatment, or the anchoring coating is fixed to the free end of the anchoring member by winding an anchoring suture.

[0014] Optionally, in the aforementioned anchoring member for a heart valve device, the anchoring member has one or two anchoring rods. When the anchoring member has two anchoring rods, the two anchoring rods are connected at free ends.

[0015] Optionally, in the aforementioned anchoring member for a heart valve device, the two anchoring rods are integrally connected at their free ends via a plurality of V-shaped curved rods.

[0016] Optionally, in the aforementioned anchoring member for a heart valve device, the anchoring rod has the shaft elastic portion integrally provided thereon.

[0017] Optionally, in the aforementioned anchoring member for a heart valve device, the axial elastic portions on the two anchoring rods are located on the same horizontal plane or are staggered and not on the same horizontal plane.

[0018] Optionally, in the anchor for a heart valve device as described above, when the axial elastic parts on the two anchor rods are staggered, the outflow end of one of the axial elastic parts is higher than the inflow end of the other axial elastic part by a height H, where H≥1mm.

[0019] Optionally, in the aforementioned anchor for a heart valve device, both of the anchor rods are of a U-shaped structure with a short inner side and a long outer side, the inner short rod ends of the two anchor rods are respectively connected to the stent as the connecting ends of the anchor, and the outer long rods of the two anchor rods are first contracted inwardly and then expanded outwardly from the outflow end to the inflow end before being connected or connected by a plurality of V-shaped curved rods to form the free end of the anchor, so that the anchor forms an anchor opening toward the inflow end and has a smoothly transitioned contraction structure and an outward expansion structure from the outflow end to the inflow end;

[0020] The shaft elastic portion is integrally arranged at the middle portion of the outer long rod.

[0021] In order to solve the aforementioned technical problems, a second aspect of the present invention provides an elastically fixed heart valve device, the elastically fixed heart valve device comprising:

[0022] a support mechanism having an outer frame;

[0023] A plurality of anchoring members are evenly arranged on the outer peripheral surface of the outer frame along the circumferential direction;

[0024] An anchor opening facing the inflow end is formed between the anchor and the outer frame, and the anchor has an axially compressible axial elastic portion.

[0025] Optionally, in the elastically fixed heart valve device as described above, the anchoring member adopts the anchoring member for a heart valve device provided by the first aspect of the present invention.

[0026] Optionally, in the elastically fixed heart valve device as described above, the outer frame includes:

[0027] An external frame body, a hollow cylindrical structure composed of several layers of external frame grids;

[0028] A plurality of curved connecting rods are evenly connected to the inflow end of the outer frame body along the circumferential direction to form a variable diameter annular structure that first increases and then decreases from the outflow end to the inflow end.

[0029] Optionally, in the elastically fixed heart valve device as described above, the curved connecting rod is formed by multiple connecting rod sections, and a notch is provided at the connection between two adjacent connecting rod sections;

[0030] The elastically fixed heart valve device further comprises:

[0031] A coating mechanism comprises an outer frame coating, wherein the outer frame coating is coated on the outer frame through outer frame sutures, and the outer frame sutures located at the bent connecting rods are respectively inserted into the corresponding notches.

[0032] Optionally, in the elastically fixed heart valve device as described above, the inflow end of the outer frame body is expanded outward and smoothly connected to the outflow end of the curved connecting rod.

[0033] Optionally, in the elastically fixed heart valve device as described above, the inflow end of the curved connecting rod is a blunt head formed by an arc surface.

[0034] Optionally, in the elastically fixed heart valve device as described above, the inflow end of the curved connecting rod is provided with a protective blunt head, which can be circular, elliptical or have an arc surface at the distal end and the diameter of the arc surface is greater than the width of the curved connecting rod.

[0035] Optionally, in the elastically fixed heart valve device as described above, a blunt through hole is provided on the blunt tip or protective blunt tip, and the inflow end of the outer frame is connected to the outer frame covering by passing an outer frame suture through the blunt through hole.

[0036] Optionally, in the elastically fixed heart valve device as described above, a marker is embedded in the blunt through hole, and the marker is made of a radiopaque material.

[0037] Optionally, in the elastically fixed heart valve device as described above, the blunt-tip through hole is a long strip-shaped through hole or a waist-shaped hole.

[0038] Optionally, in the elastically fixed heart valve device as described above, the outer frame further comprises:

[0039] A plurality of external connection blocks are evenly connected to the outflow end of the outer frame body along the circumferential direction, and the outer frame is connected to the inner frame through the external connection blocks;

[0040] The outflow end of the anchoring member in a compressed state does not exceed the outflow end of the outer connecting block.

[0041] Optionally, in the elastically fixed heart valve device as described above, the stent mechanism further comprises an inner frame, the inner frame being located within the outer frame and connected to the outer frame;

[0042] The inner frame comprises:

[0043] An inner frame body, a hollow cylindrical structure composed of several layers of inner frame grids;

[0044] A plurality of connecting rods are evenly connected to the inflow end of the inner frame body along the circumferential direction. The connecting rods are used to connect with the distal end of the external conveying system. The inflow end of the inner frame does not exceed the inflow end of the outer frame in the axial direction.

[0045] Optionally, in the elastically fixed heart valve device as described above, the inflow ends of the plurality of connecting rods are obliquely arranged at the inflow end of the inner frame body, forming a collapsed structure that collapses from the outflow end to the inflow end.

[0046] Optionally, in the elastically fixed heart valve device as described above, the inflow end of the connecting rod is provided with a connector connected to the delivery system, and the connector can be a card connector with a circular, elliptical or rectangular structure.

[0047] Optionally, in the elastically fixed heart valve device as described above, a connector through-hole is provided on the connector, and the inflow end of the inner frame is connected to the external delivery system via a pull wire passing through the connector through-hole.

[0048] Optionally, in the elastically fixed heart valve device as described above, the coating mechanism comprises an inner frame coating, and the inner frame coating is coated on the inner frame.

[0049] The positive progress effect of the present invention is:

[0050] 1. The design of the axially compressible elastic part enables the anchor to be preset to a relatively long length. After the valve is implanted, the free end of the anchor can effectively rest against the root of the valve annulus. Under the action of the valve annulus, the anchor compresses the axial elastic part. As a result, the axial elastic part can be compressed and shortened, so that no large force is exerted on the valve annulus, thereby avoiding the anchor from piercing the valve annulus.

[0051] 2. An anchoring membrane is provided at the free end of the anchoring member to facilitate endothelialization of the free end of the anchoring member and to form a whole with the root of the native valve ring.

[0052] 3. The two anchor rods of the anchor are connected by multiple V-shaped curved rods, which greatly increases the contact area between the free end of the anchor and the valve annulus.

[0053] 4. The axial elastic parts on the two anchor rods are not staggered in the same horizontal plane, which ensures the radial support force of the anchor, that is, the anchor will not flip toward the outside of the valve through the axial elastic part.

[0054] 5. The inflow end of the external frame is designed with several curved links, replacing the traditional grid-shaped outward skirt. Whether compressed and straightened or bent after expansion, the lengths of the proximal and distal ends of the curved links remain unchanged. Therefore, the film will not tear during compression and expansion, ensuring smooth compression of the inflow end of the external frame. Compared to a grid-shaped outward skirt, the curved links offer greater flexibility and circumferential wiggle room, allowing them to better adapt to the shape of the heart's inner wall.

[0055] 6. The connecting rod and notch design of the curved connecting rod allows the external frame suture to be stuck in the notch, so that the external frame suture and the external frame covering cannot slide relative to the curved connecting rod, which is conducive to the smooth expansion of the valve.

[0056] The inflow end of the curved connecting rod is set to a blunt tip to prevent it from puncturing the inner wall of the heart. In particular, a larger protective blunt tip is added to the inflow end of the curved connecting rod, so that the inflow end of the curved connecting rod forms a larger end, further preventing it from puncturing the heart. Through the design of the blunt through-hole, the connection between the external frame coating and the inflow end of the external frame can be achieved by passing the external frame suture through the blunt through-hole, further preventing the external frame coating from sliding along the curved connecting rod, and ensuring that the position of the external frame coating and the inflow end of the external frame remains stable during the implantation of the stent mechanism. A marker is embedded in the blunt through-hole so that the inflow end of the external frame can have a clear image point under the imaging equipment, which is convenient for the operator to confirm whether the position of the inflow end of the external frame meets the position requirements.

[0057] 7. In an anchor structure formed by two anchor rods, there is no fixed point in the middle of the connection between the two anchor rods. Therefore, when the anchor is compressed, the anchor rods are prone to deformation due to the lack of multiple fixed constraint points. If the anchor rods are too long, they may interfere with the external connection block in the compressed state, causing the anchor to be wrapped around the external connection block and unable to expand. By ensuring that the outflow end of the anchor in the compressed state does not exceed the outflow end of the external connection block, even if the anchor rods deform, they cannot be wrapped around the external connection block.

[0058] 8. By setting a connecting rod at the inflow end of the inner frame, the connecting rod is connected to the distal end of the external delivery system. After the inflow end of the external frame is released, the inflow end of the external frame fits against the inner wall of the heart. At this time, if it is found that the inflow end of the external frame does not fit the inner wall of the heart perfectly, the angle or position of the entire stent mechanism can be adjusted by adjusting the delivery system and the movable connecting rod, thereby achieving the purpose of controllable and adjustable stent mechanism after the inflow end of the external frame is released and expanded.

[0059] 9. A connector is provided at the inflow end of the connecting rod to achieve better connection or separation with the conveying system.

[0060] Through the design of the connector through-hole, the inner frame can be more securely connected to the external conveying system by pulling the wire through the connector through-hole. Moreover, when the inner frame is released, it can restrain the inner frame and make the release of the inner frame slower. BRIEF DESCRIPTION OF THE DRAWINGS

[0061] The disclosure of the present invention will become more apparent with reference to the accompanying drawings. It should be understood that these drawings are for illustrative purposes only and are not intended to limit the scope of protection of the present invention. In the drawings:

[0062] Figure 1A three-dimensional diagram of an embodiment of the present invention;

[0063] Figure 2(a) shows Figure 1 A three-dimensional diagram of the connection between the middle and outer frames and the anchoring members;

[0064] Figure 2(b) is a front view of Figure 2(a);

[0065] Figure 2(c) is a partial enlarged view of Figure 2(b);

[0066] FIG3( a ) is another schematic structural diagram of the anchor member of the present invention;

[0067] Figure 3(b) is a partial enlarged view of Figure 3(a);

[0068] FIG4( a ) is another schematic structural diagram of the anchor member of the present invention;

[0069] Figure 4(b) is a partial enlarged view of Figure 4(a);

[0070] FIG5( a ) is another schematic structural diagram of the external frame of the present invention;

[0071] Figure 5(b) is a partial enlarged view of Figure 5(a);

[0072] Figure 6(a) shows Figure 1 A structural diagram of the inner frame;

[0073] FIG6( b ) is a front view of FIG6( a ). DETAILED DESCRIPTION

[0074] The following describes the embodiments of the present invention through specific examples. Those skilled in the art will readily understand the other advantages and benefits of the present invention from the disclosure herein. The present invention may also be implemented or applied through various other specific embodiments, and the details in this specification may be modified or altered based on different perspectives and applications without departing from the spirit of the present invention.

[0075] It should be noted that, unless there is any conflict, the following embodiments and features therein may be combined with each other.

[0076] In the description of the present invention, it should be noted that, for directional words, such as the terms "outside", "middle", "inside", "outside", etc., the directions and positional relationships indicated are based on the directions or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and cannot be understood as limiting the specific scope of protection of the present invention.

[0077] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features. Therefore, the terms "first" and "second" may explicitly or implicitly refer to one or more of these features. Throughout the description of the present invention, "several" and "a number" mean two or more, unless otherwise specifically defined.

[0078] In this application, when describing an anchor or elastically fixed heart valve device, "distal end," "proximal end," "distal segment," and "proximal segment" are used as directional terms. These directional terms are commonly used in the field of interventional medical devices. "Distal end" and "distal segment" refer to the end or segment away from the operator during surgery, while "proximal end" and "proximal segment" refer to the end or segment closer to the operator during surgery. "Axial" refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; "radial" refers to the direction perpendicular to the "axial" direction.

[0079] In this application, when describing an anchor or elastically fixed heart valve device, "inflow end" and "outflow end" are used as directional terms, which are commonly used terms in the field of interventional medical devices, where "inflow end" refers to the end of the interventional medical device where antegrade blood first flows into the device, for example Figure 1 The “outflow end” refers to the end where antegrade blood flows out of the interventional medical device, e.g. Figure 1 The lower end of the middle.

[0080] Example 1:

[0081] Reference Figures 1 to 4(b) , this embodiment provides an anchor 400, which can be used as a part of a heart valve device to capture native leaflets.

[0082] A heart valve device typically also includes a stent mechanism comprising an outer frame 100 and an inner frame 200. The inner frame 200 is typically disposed within and connected to the outer frame 100. Anchors are typically uniformly arranged circumferentially on the outer surface of the outer frame 100. A heart valve device typically also includes a leaflet mechanism, located within the inner frame 200. This mechanism functions like a one-way valve, effectively preventing regurgitation.

[0083] The anchor 400 includes a connection end connected to the outer frame 100 and a free end located outside the connection end. The anchor 400 also includes an axially compressible axial elastic portion 410, which is located between the connection end and the free end.

[0084] This embodiment realizes that the anchor 400 can be preset to a relatively long length through the design of the axially compressible axial elastic portion 410. After the valve is implanted, it is ensured that the free end of the anchor 400 can effectively rest against the root of the valve annulus. Under the action of the valve annulus, the anchor 400 compresses the axial elastic portion 410. Therefore, due to the compressible shortening of the axial elastic portion 410, no large force is generated on the valve annulus, thereby avoiding the anchor 400 from piercing the valve annulus.

[0085] In this embodiment, the axial elastic portion 410 may be a structure that can be axially compressed, shortened, and restored.

[0086] The shaft elastic portion 410 preferably adopts a curved S-shaped portion.

[0087] In this embodiment, the axial elastic portion 410 and the anchor 400 are made integrally, that is, the connecting end, the axial elastic portion 410 and the free end of the anchor 400 are all an integral structure.

[0088] In this embodiment, in order to make the axial elastic portion 410 have better axial elasticity, the rod width of the axial elastic portion 410 is 1 / 3 to 1 / 2 of the rod width of other parts of the anchor 400.

[0089] In this embodiment, referring to FIG. 4( a ) and FIG. 4 ( b ), wire holes 420 are provided at both ends of the shaft elastic portion 410 , and the wire holes 420 allow a wire to pass through, and the axial compression of the shaft elastic portion 410 is controlled by the wire.

[0090] A pull wire is used to pull the two ends of the axial elastic part 410 closer together, thereby shortening the overall axial length of the anchor 400, which is beneficial to the delivery of the valve and the capture of the leaflets (sometimes an anchor that is too long is not necessarily beneficial to the capture of the native leaflets). After the valve implantation or leaflet capture is completed, the pull wire is released to open the axial elastic part 410, so that the free end of the anchor 400 can be against the root of the valve annulus.

[0091] In this embodiment, the free end of the anchor 400 is provided with an anchoring coating, which facilitates the endothelialization of the free end of the anchor 400 and its integration with the root of the native valve ring.

[0092] In this embodiment, the anchoring membrane can be made of medical-grade implantable materials that can promote endothelialization, such as PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene, or bovine pericardium, preferably PTFE or ePTFE.

[0093] The anchoring coating can be wound around the free end of the anchor 400 and securely fixed to the free end of the anchor 400 through heat treatment. The heat treatment temperature and duration can be selected based on the density and thickness of the PTFE or ePTFE wrapping, and are readily achievable by a person of ordinary skill in the art without requiring any creative effort. For materials not suitable for heat treatment fixation, such as TPU, ultra-high molecular weight polyethylene, or bovine pericardium, the anchoring coating can be secured to the free end of the anchor 400 by wrapping sutures. The sutures also promote endothelialization of the free end of the anchor 400.

[0094] In this embodiment, the anchoring member 400 may have one anchoring rod, or the anchoring member 400 may have two anchoring rods.

[0095] 2( a ), 2( b ), 3( a ), 4( a ) and 5( a ), when the anchor 400 has two anchor rods 430 , the two anchor rods 430 are connected as a whole at the free ends.

[0096] In this embodiment, in order to increase the contact area between the free end of the anchoring member 400 and the valve annulus, the two anchoring rods 430 are integrally connected at the free ends through a plurality of V-shaped curved rods.

[0097] For example, as shown in FIG2( b ), the free ends of the anchor members 400 are connected via a W-shaped curved rod, which may be composed of a plurality of V-shaped curved rods (the V-shaped curved rod includes a positive V-shaped structure and an inverted V-shaped structure, etc.).

[0098] In this embodiment, each anchor rod 430 has an integrally provided shaft elastic portion 410 .

[0099] In this embodiment, referring to FIG. 2( c ), the axial elastic portions 410 on the two anchor rods 430 are located on the same horizontal plane.

[0100] Referring to Figure 3(b), the axial elastic portions 410 on the two anchor rods 430 are staggered, not positioned on the same horizontal plane. This staggered arrangement ensures radial support for the anchor 400, preventing the anchor 400 from flipping outward of the valve due to the axial elastic portions 410.

[0101] In this embodiment, referring to FIG. 3( b ), when the axial elastic portions 410 on the two anchor rods 430 are staggered, the outflow end of one axial elastic portion 410 is higher than the inflow end of the other axial elastic portion 410 by a height H, where H ≥ 1 mm. This ensures that the axial elastic portions 410 on the two anchor rods 430 are fully staggered.

[0102] In this embodiment, referring to Figures 2(a) and 2(b), both anchor rods 430 are U-shaped structures with a shorter inner side and a longer outer side. The inner side refers to the side close to the central axis of the stent, and the outer side refers to the side away from the central axis of the stent. The inner short rod ends of the two anchor rods 430 are respectively connected to the outer frame 100 as the connection ends of the anchor 400. The outer long rods of the two anchor rods 430 are first converged inward and then expanded outward from the outflow end to the inflow end, and then connected or connected by a plurality of V-shaped curved rods to form the free end of the anchor 400, so that the anchor 400 forms an anchor opening 440 facing the inflow end. The anchor opening 440 has a smoothly transitioned constricted structure and an outward expansion structure from the outflow end to the inflow end. The axial elastic portion 410 is integrally arranged in the middle of the outer long rod.

[0103] The anchor opening 440 of the anchor 400 allows the native valve leaflets to be trapped within the anchor opening 440 between the anchor 400 and the outer frame 100 when the outer frame 100 is released. After the outer frame 100 is fully released, it expands and squeezes the anchor 400, forcing the anchor 400 against the inner wall of the ventricle. The anchor 400, under the interaction of the inner wall of the ventricle and the outer frame 100, more securely clamps the native valve leaflets. The tapered structure of the anchor 400 also increases the clamping force between the anchor 400 and the leaflets. Moreover, when the ventricle contracts, the valve will be subjected to blood pressure directed toward the atrium. By having the free end of the anchor 400 abut against the root of the valve annulus, the upward thrust of the stent mechanism caused by the ventricular pressure can be offset. Compared with the traditional valve, the free end of the anchor cannot abut against the root of the valve annulus. When the traditional valve is subjected to blood pressure, the entire valve will move toward the atrium until the anchor abuts against the root of the valve annulus. The valve can reach a stable state, and paravalvular leakage of the valve is very likely to occur. The shaking of the valve can also easily cause damage to the heart. The free end of the anchor 400 of the present application always abuts against the root of the valve annulus, so when the valve is subjected to blood pressure, it can maintain a more stable state without shaking. The outward expansion structure of the anchor 400 is also more adapted to the shape of the root of the valve annulus, increasing the contact area between the free end of the anchor and the root of the valve annulus. When under pressure, it will not puncture the root of the valve annulus. The free ends of several V-shaped curved rods also increase the contact area between the free end of the anchor 400 and the valve annulus. The further design of the axial elastic part 410 avoids the puncture of the valve annulus by the anchor 4000.

[0104] Example 2:

[0105] Reference Figure 1 This embodiment provides an elastically fixed heart valve device, which includes a stent mechanism and a plurality of anchors. The stent mechanism has an outer frame 100, and the anchors are evenly arranged on the outer peripheral surface of the outer frame 100 along the circumferential direction. An anchor opening facing the inflow end is formed between the anchor and the outer frame 100, and the anchor has an axially compressible axial elastic portion.

[0106] The axial elastic portion of this embodiment adopts the axial elastic portion 410 of the anchor member 400 provided in each embodiment of Example 1.

[0107] In this embodiment, the anchoring member of this embodiment adopts the anchoring member 400 provided in each embodiment of Example 1.

[0108] In this embodiment, referring to Figure 5(a), the external frame 100 includes an external frame body 110 and a plurality of curved connecting rods 120. The external frame body 110 is a hollow, cylindrical structure composed of several layers of external frame grids. The curved connecting rods 120 are evenly connected to the inflow end of the external frame body 110 along the circumference, forming a variable diameter annular structure that first increases and then decreases from the outflow end to the inflow end.

[0109] The inflow end of the conventional external frame 100 is usually formed by directly expanding the external frame grid of the external frame body 110 to form an outward-expanded skirt. Since the axial length of the compressed external frame grid can become very long, it will seriously tear the external frame coating. Therefore, the present invention abandons this structure and adopts a plurality of curved connecting rods 120 to replace the traditional outward-expanded skirt. Whether the curved connecting rods 120 are compressed and straightened or in a bent state after expansion, the length of the proximal and distal ends of the curved connecting rods 120 will not change. Therefore, the compression and expansion process will not cause the coating to be torn, thereby achieving smooth compression of the inflow end of the external frame. The curved connecting rods 120 are more flexible than the grid-shaped outward-expanded skirt and have a certain amount of movement space in the circumferential direction. Therefore, the curved connecting rods 120 can better adapt to the shape of the inner wall of the heart.

[0110] In this embodiment, referring to FIG. 5( a ) and FIG. 5 ( b ), the curved link 120 is formed by a plurality of link sections 120 a , and a notch 120 b is formed at the connection between two adjacent link sections 120 a .

[0111] The elastically fixed heart valve device also includes a coating mechanism comprising an outer frame coating. The outer frame coating is wrapped around the outer frame via outer frame sutures. The outer frame sutures located at the curved link 120 are respectively snapped into corresponding recesses 120b. Because the curved link 120 at the inflow end of the outer frame 100 is highly deformed, i.e., the central portion of the curved link 120 is significantly outwardly expanded, the outer frame coating and the outer frame sutures that secure the coating easily slide relative to the curved link 120 when the valve is compressed. However, when the valve expands and opens, the outer frame coating and the outer frame sutures cannot return to their original positions, which can easily cause the valve to not fully open or to deform. However, the provision of recesses 120b allows the outer frame sutures to snap into recesses 120b, preventing the outer frame sutures and the outer frame coating from sliding relative to the curved link 120, thus facilitating smooth expansion of the valve.

[0112] In this embodiment, the inflow end of the outer frame body 110 is flared outward and smoothly connected to the outflow end of the curved connecting rod 120. This allows the outer frame 100 to quickly expand to the target size after release. This also avoids the risk of the outer frame body 110 and the curved connecting rod 120 being broken during compression.

[0113] In this embodiment, the inflow end of the curved connecting rod 120 is a blunt head formed by an arc surface, which can prevent the inner wall of the heart from being punctured.

[0114] In this embodiment, referring to Figures 5(a) and 5(b), a protective blunt tip 121 is provided at the inflow end of the curved connecting rod 120. The protective blunt tip 121 may be circular, elliptical, or have an arcuate surface at the distal end, the diameter of which is greater than the width of the curved connecting rod 120. The larger protective blunt tip 121 is provided at the inflow end of the curved connecting rod 120, thereby forming a larger end, further preventing the inflow end of the curved connecting rod 120 from piercing the heart.

[0115] In this embodiment, referring to Figures 5(a) and 5(b), a blunt through-hole 122 is provided on the blunt tip or protective blunt tip 121, and the inflow end of the external frame 100 is connected to the external frame membrane by passing external frame sutures through the blunt through-hole 122. The design of the blunt through-hole allows the external frame membrane to be connected to the external frame inflow end by passing sutures through the blunt through-hole, preventing the external frame membrane from sliding along the curved connecting rod, and ensuring that the position of the external frame membrane and the external frame inflow end remains stable during the implantation of the stent mechanism.

[0116] In this embodiment, a marker is embedded within the blunt-tip through-hole 122. The marker is made of a radiopaque material. This allows the inflow end of the external frame 100 to be clearly visible on imaging equipment, making it easier for operators to confirm whether the inflow end of the external frame 100 meets the required position.

[0117] In this embodiment, the blunt through hole 122 is an elongated through hole or a waist-shaped hole. The design of the elongated through hole or waist-shaped hole does not affect the passage of the suture after the marker is embedded. The marker can be embedded on the inner wall of the blunt through hole 122 before or after the suture is passed through.

[0118] In this embodiment, referring to FIG5(a), the outer frame body 110 is a hollow, cylindrical structure formed by three layers of outer frame mesh. The inflow end of the outer frame body 110 is an outward-expanding structure, and the outflow end is a contracting structure. The mesh shapes of the three layers of outer frame mesh can be designed to be the same or different as needed. The three layers of mesh shown in FIG5(a) utilize different mesh shapes.

[0119] When the outer frame body 110 is designed with an anchor 400, the anchor 400 is located on a layer of outer frame grid close to the outflow end, preferably on the side of the inflow end of the folded structure.

[0120] In this embodiment, referring to FIG. 5( a ), the outer frame 100 includes a plurality of external connection blocks 130 circumferentially connected to the outflow end of the outer frame body 110 . From the inflow end to the outflow end, the outer frame 100 includes a plurality of curved connecting rods 120 , the outer frame body 110 , and the external connection blocks 130 , which are sequentially connected. The outer frame 100 is connected to the inner frame 200 via the external connection blocks 130 .

[0121] The outflow end of the anchor 400 in the compressed state does not extend beyond the outflow end of the external connection block 130. During transport, the anchor 400 needs to be straightened, with the free end of the anchor 400 (i.e., the end away from the connection to the external frame 100) flipped 180° to form a relatively straight shape for compression. In an anchor structure formed by two anchor rods 430, there is no fixed point in the middle where the two anchor rods 430 are connected. Therefore, when the anchor is compressed, the anchor rods 430 are prone to deformation due to the lack of multiple fixed restraint points. If the anchor rods 430 are too long, they may interfere with the external connection block 130 in the compressed state, causing the anchor 400 to be trapped on the external connection block 130 and unable to expand. By ensuring that the outflow end of the anchor 400 in the compressed state does not extend beyond the outflow end of the external connection block 130, even if the anchor rods 400 deform, they cannot be trapped on the external connection block 130.

[0122] In this embodiment, referring to Figure 1 The bracket mechanism further includes an inner frame 200 , which is disposed inside the outer frame 100 and connected to the outer frame 100 .

[0123] In this embodiment, the elastically fixed heart valve device generally further includes a leaflet mechanism, which is located in the inner frame 200. The leaflet mechanism forms a function similar to a "one-way valve", which can effectively avoid reflux.

[0124] In this embodiment, referring to Figure 1 6(a) and 6(b), the inner frame 200 includes an inner frame body 210 and a plurality of connecting rods 220. The inner frame body 210 is a hollow cylindrical structure composed of several layers of inner frame grids. A plurality of connecting rods 220 are evenly connected to the inflow end of the inner frame body 210 along the circumference, and the connecting rods 220 are used to connect to the distal end of the external delivery system. By arranging the connecting rods 220 at the inflow end of the inner frame body 210, the connecting rods 220 are connected to the distal end of the external delivery system. After the inflow end of the outer frame 100 is released, the inflow end of the outer frame 100 fits with the inner wall of the heart. At this time, if it is found that the inflow end of the outer frame 100 is not perfectly fitted with the inner wall of the heart, the angle or position of the entire stent mechanism can be adjusted by adjusting the delivery system and the movable connecting rods 220, thereby achieving the purpose of controllable and adjustable stent mechanism of the inflow end of the outer frame 100 after the inflow end is released and expanded.

[0125] In this embodiment, the inflow ends of the connecting rods 220 are tilted to the inflow end of the inner frame body 210, and the connecting rods 220 form a retracted structure that is retracted from the outflow end to the inflow end, which is convenient for connection with the conveyor.

[0126] In this embodiment, referring to FIG6( b ), a connector 221 is provided at the inflow end of the connecting rod 220 . The connector 221 may be a snap-fit ​​connector having a circular, oval, or rectangular structure. The connector 221 is used to snap-fit ​​with the conveying system to facilitate connection or separation with the conveying system.

[0127] In this embodiment, a connector through hole 222 is provided on the connector 221, and the inflow end of the inner frame 200 can pass through the connector through hole 222 by a pull wire, so that the inner frame can be more securely connected to the conveying system, and when the inner frame is released, it can play a role in restraining the inner frame, so that the release of the inner frame is slower.

[0128] In this embodiment, the coating mechanism includes an inner frame coating, and the inner frame coating is coated on the inner frame 200 .

[0129] In this embodiment, when the inner frame 200 is disposed within the outer frame 100, the inflow end of the inner frame 200 does not exceed the inflow end of the outer frame 100 in the axial direction. An inflow end of the inner frame 200 that is too high will cause the inflow end of the inner frame 200 to abut against the inner wall of the atrium, causing damage to the atrium. In particular, during atrial contraction, an inflow end of the inner frame 200 that is too high will further impact and abut against the inner wall of the atrium.

[0130] In this embodiment, referring to FIG6( b ), the inner frame 200 further includes a plurality of inner connecting blocks 230, which are uniformly connected to the outflow end of the inner frame body 210 along the circumference. In this case, the inner frame 200 includes a plurality of connecting rods 220, the inner frame body 210, and the inner connecting blocks 230, which are sequentially connected from the inflow end to the outflow end. The inner frame 200 is connected to the outer frame 100 via the inner connecting blocks 230.

[0131] Preferably, the inner frame 200 is connected to the outer frame 100 by connecting the inner connecting block 230 with the outer connecting block 130 .

[0132] In this embodiment, referring to Figures 5(a) and 6(b), both the external connecting block 130 and the internal connecting block 230 have outflow-end folding structures that converge toward the outflow end. The outflow-end folding structures have a folding angle α, with 45°≤α≤75°. Excessively large folding angles can affect the endothelialization rate at the outflow end of the external frame 100 or the internal frame 200. Therefore, an appropriate folding angle can ensure a satisfactory endothelialization rate while protecting the heart's inner wall from collision and puncture caused by the distal end of the external connecting block 130 or the internal connecting block 230.

[0133] In this embodiment, the outer diameter of the inner frame 200 is no larger than the inner diameter of the outer frame 100 at the same cross-section. The outflow end of the inner frame 200 is connected to the outflow end of the outer frame 100, and at least the middle portion of the inner frame 200 to the inflow end is suspended inside the outer frame 100. This ensures that, except for the connection between the inner frame and the outer frame 100, the rest of the inner frame 200 is suspended inside the outer frame 100. During cardiac contraction and expansion, the effects of deformation and movement of the outer frame on the shape of the inner frame are minimized, preventing deformation of the leaflet mechanism at the apposition site and reducing regurgitation of the prosthetic heart valve.

[0134] In this embodiment, referring to Figure 6(b), the inner frame body 210 comprises a hollow, cylindrical structure formed by two layers of inner frame mesh. The outflow end of the inner frame body 210 is a collapsed structure. The mesh shapes of the two layers of inner frame mesh can be designed to be the same or different as needed. The two layers of mesh shown in Figure 6(b) utilize different mesh shapes.

[0135] In this embodiment, referring to FIG6( b ), each layer of the inner frame grid is connected by a connecting post 240 , and two adjacent layers of polygonal frames are heat-set to form the inner frame body 210 . Leaflet suture holes 241 are provided on the connecting post 240 located on one layer of the inner frame grid, through which the inner frame 200 and the leaflet mechanism are sutured. The number of leaflet suture holes 241 is at least two to meet the leaflet requirements of the heart valve device. The leaflet suture holes 241 are evenly distributed along the circumference of the connecting post 240 . Alternatively, each connecting post 240 may be provided with a leaflet suture hole 241 .

[0136] It should be noted that while the above embodiments describe a double-layer stent-valve, anchor 400 can also be used with a single-layer stent, for example, a valve having only an outer frame without an inner frame. In other words, the design of anchor 400 is not limited to the valve stent described in the embodiments; it can be applied to any foreseeable valve stent.

[0137] The present invention has been described in detail above with reference to the embodiments of the accompanying drawings. A person skilled in the art can make various modifications to the present invention based on the above description. Therefore, certain details in the embodiments should not be construed as limiting the present invention. The scope of protection of the present invention shall be determined by the scope defined by the appended claims.

Claims

1. An elastically fixed heart valve device, comprising: a support mechanism having an outer frame; A plurality of anchoring members are evenly arranged on the outer peripheral surface of the outer frame along the circumferential direction; It is characterized in that an anchor opening facing the inflow end is formed between the anchor and the outer frame, and the anchor has an axially compressible axial elastic portion; The anchor member has two anchor rods, and the two anchor rods are connected at free ends; The anchor rod is provided with the shaft elastic portion integrally arranged thereon; The axial elastic parts on the two anchor rods are staggered; The height by which the outflow end of one of the axial elastic parts is higher than the inflow end of the other axial elastic part is H, where H is ≥ 1 mm.

2. The elastically fixed heart valve device according to claim 1, wherein: The outer frame includes: An external frame body, a hollow cylindrical structure composed of several layers of external frame grids; A plurality of curved connecting rods are evenly connected to the inflow end of the outer frame body along the circumferential direction to form a variable diameter annular structure that first increases and then decreases from the outflow end to the inflow end.

3. The elastically fixed heart valve device according to claim 2, wherein: The curved connecting rod is formed by multiple connecting rod sections, and the connection between two adjacent connecting rod sections has a notch; The elastically fixed heart valve device further comprises: A coating mechanism comprises an outer frame coating, wherein the outer frame coating is coated on the outer frame through outer frame sutures, and the outer frame sutures located at the bent connecting rods are respectively inserted into the corresponding notches.

4. The elastically fixed heart valve device according to claim 1, 2 or 3, wherein: The shaft elastic portion adopts a curved S-shaped portion; and / or, the axial elastic portion and the anchoring member are made integrally; And / or, the rod width of the axial elastic portion is 1 / 3 to 1 / 2 of the rod width of other parts of the anchor member.

5. The elastically fixed heart valve device according to claim 1, 2 or 3, wherein: Both ends of the axial elastic part are provided with wire drawing holes, and the wire drawing holes allow the wire to pass through, and the axial compression of the axial elastic part is controlled by the wire drawing.

6. The elastically fixed heart valve device according to claim 1, 2 or 3, wherein: The free end of the anchor is provided with an anchor coating.

7. The elastically fixed heart valve device according to claim 6, wherein: The anchoring membrane is made of any one of PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene and bovine pericardium, a medical-grade implant material that promotes endothelialization; The anchoring coating is fixed to the free end of the anchoring member by winding and heat treatment, or the anchoring coating is fixed to the free end of the anchoring member by winding an anchoring suture.

8. The elastically fixed heart valve device according to claim 7, wherein: The two anchor rods are integrally connected at their free ends through a plurality of V-shaped curved rods.

9. The elastically fixed heart valve device according to claim 1, wherein: The two anchor rods are both U-shaped structures with a short inner side and a long outer side. The inner short rod ends of the two anchor rods are respectively connected to the external frame as the connecting ends of the anchor member. The outer long rods of the two anchor rods are first gathered inwardly and then expanded outwardly from the outflow end to the inflow end, and then connected or connected by a plurality of V-shaped curved rods to form the free end of the anchor member, so that the anchor member forms an anchor member opening toward the inflow end and has a smoothly transitioned shrinking structure and an outward expansion structure from the outflow end to the inflow end. The shaft elastic portion is integrally arranged at the middle portion of the outer long rod of the anchor rod.

10. The elastically fixed heart valve device according to claim 1, 2 or 3, wherein: The support mechanism further comprises an inner frame, the inner frame being located within the outer frame and connected to the outer frame; The inner frame comprises: An inner frame body, a hollow cylindrical structure composed of several layers of inner frame grids; A plurality of connecting rods are evenly connected to the inflow end of the inner frame body along the circumferential direction. The connecting rods are used to connect with the distal end of the external conveying system. The inflow end of the inner frame does not exceed the inflow end of the outer frame in the axial direction.

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