Elastically fixed heart valve device

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an elastically fixed heart valve device. A resiliently secured heart valve device includes: a stent mechanism having an outer frame; and the anchoring pieces are evenly arranged on the peripheral face of the outer frame in the circumferential direction, anchoring piece openings facing the inflow end are formed between the anchoring pieces and the outer frame, and the anchoring pieces are provided with axial elastic parts capable of being axially compressed. Through the design of the axial elastic part which can be compressed axially, the anchoring part can be preset to be relatively long, after the valve is implanted, it is guaranteed that the free end of the anchoring part can effectively abut against the root of the valve ring, the anchoring part compresses the axial elastic part under the action of the valve ring, and therefore the axial elastic part can be compressed to be short under the action that the axial elastic part can be compressed to be short. And large force cannot be generated on the valve ring, so that the valve ring is prevented from being punctured by the anchoring piece.

Description

Technical Field

[0001] The 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 to prevent blood reflux. 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 the treatment of mitral regurgitation, so mitral regurgitation has received more research. However, with the deepening of 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 the occurrence of tricuspid regurgitation, the 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 to treat 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 fit 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 native leaflets, causing the risk of valve slippage or damaging the native leaflets, and aims 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, the anchor comprising a connecting end connected to the stent and a free end located outside the connecting end, the anchor also comprising an axially compressible axial elastic portion, the axial elastic portion being located between the connecting end and the free end.

[0007] Optionally, in the anchoring member for a heart valve device as described above, the axial elastic portion adopts a curved S-shaped curve.

[0008] Optionally, in the anchoring member for a heart valve device as described above, the axial elastic portion is made integrally 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 allow 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 anchoring member for a heart valve device as described above, the free end of the anchoring member 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 implant 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, and when the anchoring member has two anchoring rods, the two anchoring rods are connected at free ends.

[0015] Optionally, in the anchoring member for a heart valve device as described above, the two anchoring rods are integrally connected at the 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 anchoring member for the heart valve device as described above, both of the two anchoring 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 anchoring rods are respectively connected to the stent as the connecting ends of the anchoring member, and the outer long rods of the two anchoring rods are first gathered inwards from the outflow end to the inflow end and then expanded outwards and then connected or connected through a plurality of V-shaped curved rods to form the free end of the anchoring member, so that the anchoring member forms an anchoring 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;

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

[0021] In order to solve the above technical problems, the 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 an 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 comprises:

[0027] An external frame body, a hollow cylindrical structure consisting 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 is provided, wherein the coating mechanism has 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 bent connecting rod is provided with a protective blunt head, which may 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 bent connecting rod.

[0035] Optionally, in the elastically fixed heart valve device as described above, a blunt through hole is provided on the blunt head or the protective blunt head, 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 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 the 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 support mechanism further comprises an inner frame, the inner frame is located inside the outer frame and connected to the outer frame;

[0042] The inner frame comprises:

[0043] An inner frame body, a hollow cylindrical structure consisting 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, and the connecting rods are used to connect with the far 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 to form a gathering structure that gathers 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 clamping 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 by passing a pull wire 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 and progressive effects of the present invention are:

[0050] 1. The design of the axially compressible axial elastic part enables the anchor to be preset to a relatively long length. 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. Under the action of the valve ring, 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 ring, thereby avoiding the anchor from piercing the valve ring.

[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 an integral body with the root of the native valve ring.

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

[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 to the outside of the valve through the axial elastic part.

[0054] 5. The inflow end of the external frame is provided with a plurality of curved connecting rods instead of the traditional grid shape as the outward expansion skirt part. Whether the curved connecting rod is compressed and straightened or in a bent state after expansion, the length of the proximal and distal ends of the curved connecting rod will not change. Therefore, the film will not be torn during the compression and expansion process, and the smooth compression of the inflow end of the external frame is achieved. The curved connecting rod is more flexible than the outward expansion skirt in the grid shape, and has a certain activity space in the circumferential direction, so the curved connecting rod can better adapt to the shape of the inner wall of the heart.

[0055] 6. The connecting rod and notch design of the curved connecting rod allows the external frame suture to be inserted into 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 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 an obvious image point under the imaging device, 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 the anchor structure formed by two anchor rods, there is no fixed point in the middle part where the two anchor rods are connected. Therefore, when the anchor is compressed, the anchor will be easily deformed due to the lack of too many fixed constraint points. If the anchor is too long, the anchor may interfere with the outer connection block in the compressed state, and the anchor will be sleeved on the outer connection block and cannot expand and open. By ensuring that the outflow end of the anchor in the compressed state does not exceed the outflow end of the outer connection block, even if the anchor is deformed, it cannot be sleeved on the outer connection block.

[0058] 8. A connecting rod is provided at the inflow end of the inner frame, and 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. If it is found that the inflow end of the external frame does not fit the inner wall of the heart perfectly, the delivery system can be adjusted to move the connecting rod, thereby adjusting the angle or position of the entire stent mechanism, 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, it can be achieved by pulling a wire through the connector through-hole, so that the inner frame can be more securely connected to the external conveying system, and 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 only for illustrative purposes and are not intended to limit the scope of protection of the present invention. In the drawings:

[0062] Figure 1A stereogram 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 anchors;

[0064] FIG2( b ) is a front view of FIG2( a );

[0065] FIG2(c) is a partial enlarged view of FIG2(b);

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

[0067] FIG3( b ) is a partial enlarged view of FIG3( a );

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

[0069] FIG4( b ) is a partial enlarged view of FIG4( a );

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

[0071] FIG5( b ) is a partial enlarged view of FIG5( a );

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

[0073] FIG. 6( b ) is a front view of FIG. 6( a ). DETAILED DESCRIPTION

[0074] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention.

[0075] It should be noted that the following embodiments and features therein may be combined with each other if there is no conflict.

[0076] In the description of the present invention, it should be noted that directional words such as the terms "outside", "middle", "inside", "outside", etc., which indicate directions and positional relationships, are based on the directions or positional relationships shown in the 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 protection scope of the present invention.

[0077] In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features. Therefore, the definition of "first" and "second" features can explicitly or implicitly include one or more of the features. In the description of the present invention, "several" and "a number" mean two or more, unless otherwise clearly and 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 words, which are commonly used terms in the field of interventional medical devices, where "distal end" and "distal segment" refer to the end or segment away from the operator during surgery, and "proximal end" and "proximal segment" refer to the end or segment close to the operator during surgery. "Axial" refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; "radial" refers to the direction perpendicular to the above "axial".

[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 conventional 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, e.g. 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 .

[0080] Embodiment 1:

[0081] Reference Figure 1 to Figure 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] The heart valve device generally further includes a stent mechanism, which includes an outer frame 100 and an inner frame 200, wherein the inner frame 200 is generally disposed in the outer frame 100 and connected to the outer frame 100. The anchors are generally uniformly disposed on the outer circumferential surface of the outer frame 100 along the circumferential direction. The heart valve device generally further includes a leaflet mechanism, which is located in the inner frame 200 and forms a function similar to a "one-way valve" through the leaflet mechanism, which can well avoid the reflux phenomenon.

[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] In this embodiment, the anchor 400 is designed with an axially compressible axial elastic portion 410, so that a relatively long length can be preset. After the valve is implanted, the free end of the anchor 400 can be effectively 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, a large force will not be exerted 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 is made integrally with the anchor 400, that is, the connecting end of the anchor 400, the axial elastic portion 410 and the free end 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] The two ends of the axial elastic portion 410 are pulled together by a pull wire, 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 portion 410, so that the free end of the anchor 400 can be against the root of the valve ring.

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

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

[0093] The anchoring film can be wound around the free end of the anchor 400, and the anchoring film can be firmly fixed to the free end of the anchor 400 by heat treatment. The temperature and time of the heat treatment can be selected according to the density and thickness of the PTFE or ePTFE winding, and can be obtained by ordinary technicians in this field without creative labor. For materials such as TPU, ultra-high molecular weight polyethylene or bovine pericardium that are not suitable for heat treatment and fixation, the anchoring film can be fixed to the free end of the anchor 400 by winding with sutures, wherein the sutures also have the function of promoting endothelialization of the free end of the anchor 400.

[0094] In this embodiment, the anchor 400 may have one anchor rod, or the anchor 400 may have two anchor 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 FIG. 2( b ), the free end of the anchor 400 is 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 arranged 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] 3(b), the axial elastic parts 410 on the two anchor rods 430 are staggered and arranged on different horizontal planes. The staggered arrangement of the axial elastic parts 410 on the two anchor rods 430 on different horizontal planes ensures the radial support force of the anchor 400, that is, the anchor 400 will not flip to the outside of the valve through the axial elastic parts 410.

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

[0102] In this embodiment, referring to FIG. 2(a) and FIG. 2(b), both anchor rods 430 are U-shaped structures with a short inner side and a long outer side, where the inner side refers to the side close to the central axis of the stent, and the corresponding 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 connecting ends of the anchor 400, and the outer long rods of the two anchor rods 430 are first gathered inward from the outflow end to the inflow end and then expanded outward, and then connected or connected through 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, and the anchor opening 440 has a smoothly transitioned shrinking structure and an outward expansion structure from the outflow end to the inflow end. The shaft elastic part 410 is integrally arranged in the middle of the outer long rod.

[0103] Through the design of the anchor opening 440 of the anchor 400, when the external frame 100 is released, the native leaflet can be stuck in the anchor opening 440 between the anchor 400 and the external frame 100, and after the external frame 100 is completely released, it expands and squeezes the anchor 400, so that the anchor 400 is close to the inner wall of the ventricle. Under the action of the inner wall of the ventricle and the external frame 100, the anchor 400 clamps the native leaflet more firmly. The shrinkage structure of the anchor 400 can also increase the clamping force between the anchor 400 and the leaflet. Moreover, when the ventricle contracts, the valve will be subjected to blood pressure directed toward the atrium. The free end of the anchor 400 abuts against the root of the valve ring, which can offset the upward thrust of the ventricular pressure on the stent mechanism. Compared with the traditional valve, the free end of the anchor cannot abut against the root of the valve ring. 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 ring. The valve can reach a stable state, and paravalvular leakage 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 ring, 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 more adaptable 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, the root of the valve annulus will not be punctured. 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] Embodiment 2:

[0105] Reference Figure 1 The present 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. The anchors are evenly arranged on the outer circumferential 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. 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 FIG. 5( a ), the outer frame 100 includes an outer frame body 110 and a plurality of curved connecting rods 120. The outer frame body 110 is a hollow cylindrical structure composed of a plurality of layers of outer frame grids. The plurality of curved connecting rods 120 are evenly connected to the inflow end of the outer frame body 110 along the circumferential direction, and the plurality of curved connecting rods 120 form a variable diameter annular structure that increases first and then decreases from the outflow end to the inflow end.

[0109] The inflow end of the traditional external frame 100 usually directly adopts the external frame grid of the external frame body 110 to expand outward to form an outward expansion 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 the above-mentioned structure and adopts a plurality of curved connecting rods 120 to replace the traditional outward expansion skirt. Whether the curved connecting rod 120 is compressed and straightened or in a bent state after expansion, it will not change the length of the proximal and distal ends of the curved connecting rod 120. Therefore, the coating will not be torn during the compression and expansion process, thereby achieving smooth compression of the inflow end of the external frame. The curved connecting rod 120 is more flexible than the outward expansion skirt in the shape of a grid, and has a certain activity space in the circumferential direction, so the curved connecting rod 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 provided at a connection between two adjacent link sections 120 a .

[0111] The elastically fixed heart valve device also includes a coating mechanism, which has an outer frame coating, and the outer frame coating is coated on the outer frame through the outer frame sutures, and the outer frame sutures located at the curved connecting rod 120 are respectively inserted into the corresponding notches 120b. Since the curved connecting rod 120 at the inflow end of the outer frame 100 has a large deformation degree, that is, the middle part of the curved connecting rod 120 has a large degree of outward expansion, when the valve is pressed and gripped, the outer frame coating and the outer frame sutures of the fixed coating are easy to slide relative to the curved connecting rod 120, and when the valve expands and opens, the outer frame coating and the outer frame sutures cannot return to their original positions, which easily causes the valve to be unable to fully open or to open and deform, and through the setting of the notches 120b, the outer frame sutures can be inserted into the notches 120b, and then the outer frame sutures and the outer frame coating cannot slide relative to the curved connecting rod 120, which is conducive to the smooth expansion of the valve.

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

[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 pierced.

[0114] In this embodiment, referring to Fig. 5(a) and Fig. 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 arc surface at the distal end, and the diameter of the arc surface is greater than the width of the curved connecting rod 120. A larger protective blunt tip 121 is provided at the inflow end of the curved connecting rod 120, so that the inflow end of the curved connecting rod 120 forms a larger tip, further preventing it from stabbing the heart.

[0115] In this embodiment, referring to Fig. 5(a) and Fig. 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 coating by the external frame suture thread passing through the blunt through hole 122. Through the design of the blunt through hole, the connection between the external frame coating and the external frame inflow end can be achieved by passing the suture thread through the blunt through hole, preventing the external frame coating from sliding along the curved connecting rod, and ensuring that the positions of the external frame coating and the external frame inflow end remain stable during the implantation of the stent mechanism.

[0116] In this embodiment, a marker is embedded in the blunt through hole 122, and the marker is made of a radiopaque material. The marker is embedded in the blunt through hole 122, so that the inflow end of the external frame 100 can have an obvious image point under the imaging device, which is convenient for the operator to confirm whether the position of the inflow end of the external frame 100 meets the position requirements.

[0117] In this embodiment, the blunt through hole 122 is a long strip through hole or a waist-shaped hole. The design of the long strip 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 passes through.

[0118] In this embodiment, referring to FIG5(a), the outer frame body 110 is a hollow cylindrical structure composed of three layers of outer frame grids, the inflow end of the outer frame body 110 is an outward expansion structure and the outflow end is a contraction structure. The grid shapes of the three layers of outer frame grids can be designed to be the same or different as needed, and the three layers of grids shown in FIG5(a) are different grid shapes.

[0119] When the outer frame body 110 is designed with an anchor 400, the anchor 400 is located on a layer of the 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 has a plurality of external connection blocks 130, which are uniformly connected to the outflow end of the outer frame body 110 along the circumferential direction. At this time, the outer frame 100 includes a plurality of curved connecting rods 120, the outer frame body 110 and the external connection blocks 130 connected in sequence from the inflow end to the outflow end. The outer frame 100 is connected to the inner frame 200 through the external connection blocks 130.

[0121] The outflow end of the anchor 400 in the compressed state does not exceed the outflow end of the external connection block 130. The anchor 400 needs to be straightened during transportation, and the free end of the anchor 400 (i.e., the end away from the connection with the external frame 100) is turned 180° to form a relatively straight shape for compression. When the anchor structure is formed by two anchor rods 430, there is no fixed point in the middle part where the two anchor rods 430 are connected. Therefore, when the anchor is compressed, the anchor rod 430 will be easily deformed due to the lack of too many fixed constraint points. If the anchor rod 430 is too long, the anchor rod 430 may interfere with the external connection block 130 in the compressed state, and the anchor 400 may be sleeved on the external connection block 130 and cannot be expanded and opened. By ensuring that the outflow end of the anchor 400 in the compressed state does not exceed the outflow end of the external connection block 130, even if the anchor rod 400 is deformed, it cannot be sleeved on the external connection block 130.

[0122] In this embodiment, refer to Figure 1 The support mechanism also has 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 also 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, refer 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 a plurality of 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 circumferential direction, and the connecting rods 220 are used to connect with the distal end of the external delivery system. By arranging the connecting rods 220 at the inflow end of the inner frame body 210, and connecting the connecting rods 220 with 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 expansion is released.

[0125] In this embodiment, the inflow ends of the plurality of connecting rods 220 are obliquely arranged at the inflow end of the inner frame body 210, and the plurality of connecting rods 220 form a gathering structure that gathers 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 , and the connector 221 may be a card connector of a circular, elliptical or rectangular structure. The connector 221 is used to be card-connected 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 the 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 comprises 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 arranged in 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, especially during atrial contraction, an inflow end of the inner frame 200 that is too high will impact against the inner wall of the atrium more.

[0130] In this embodiment, referring to FIG. 6( b ), the inner frame 200 further includes a plurality of inner connection blocks 230, which are uniformly connected to the outflow end of the inner frame body 210 along the circumferential direction. In this case, the inner frame 200 includes a plurality of connection rods 220, the inner frame body 210, and the inner connection blocks 230 connected in sequence from the inflow end to the outflow end. The inner frame 200 is connected to the outer frame 100 through the inner connection blocks 230.

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

[0132] In this embodiment, referring to FIG. 5( a) and FIG. 6( b), both the outer connection block 130 and the inner connection block 230 are outflow end folding structures that fold toward the outflow end. The folding angle of the outflow end folding structure is α, 45°≤α≤75°. If the folding angle is too large, the speed of endothelialization of the outflow end of the outer frame 100 or the outflow end of the inner frame 200 will be affected. Therefore, an appropriate folding angle can meet the endothelialization speed and protect the inner wall of the heart from being punctured by the collision of the distal end of the outer connection block 130 or the inner connection block 230.

[0133] In this embodiment, the outer diameter of the inner frame 200 is not greater 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 part of the inner frame 200 to the inflow end is suspended inside the outer frame 100. In this way, except for the connection between the two, the other parts of the inner frame 200 can be suspended inside the outer frame 100, and during the contraction and expansion of the heart, the influence of the deformation, movement and other changes of the outer frame on the shape of the inner frame is minimized, the deformation of the valve leaf mechanism apposition site is avoided, and the regurgitation of the artificial heart valve is reduced.

[0134] In this embodiment, referring to FIG6(b), the inner frame body 210 is a hollow cylindrical structure composed of two layers of inner frame grids, and the outflow end of the inner frame body 210 is a retracted structure. The grid shapes of the two layers of inner frame grids can be designed to be the same or different as needed. The two layers of grids shown in FIG6(b) are designed to have different grid shapes.

[0135] In this embodiment, referring to FIG. 6( b ), each layer of the inner frame grid is connected by a connecting column 240, and two adjacent layers of polygonal frames are heat-formed to form an inner frame body 210. A leaflet suture hole 241 is provided on the connecting column 240 where one layer of the inner frame grid is located, and the inner frame 200 is sutured and connected to the leaflet mechanism through the leaflet suture hole 241. The number of leaflet suture holes 241 is at least 2 to meet the leaflet requirements of the heart valve device. The leaflet suture holes 241 are evenly distributed on the connecting column 240 along the circumferential direction. Leaflet suture holes 241 can also be provided on each connecting column 240.

[0136] It should be noted that although the above embodiment describes a double-layer stent valve, the anchor 400 can also be used in a single-layer stent, for example, a valve having only an outer frame but no inner frame. That is, the design of the anchor 400 should not be limited to the valve stent in the embodiment, and it can be applied to foreseeable valve stents.

[0137] The present invention is described in detail above in conjunction with the embodiments of the accompanying drawings. A person skilled in the art can make various variations of the present invention according to the above description. Therefore, some details in the embodiments should not be construed as limiting the present invention, and the present invention shall be protected by the scope defined by the attached claims.

Claims

1. An elastically fixed heart valve device, the 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.

2. The elastically fixed heart valve device according to claim 1, characterized in that: The outer frame comprises: An external frame body, a hollow cylindrical structure consisting 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, characterized in that: 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; The elastically fixed heart valve device further comprises: A coating mechanism is provided, wherein the coating mechanism has 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, characterized in that: The shaft elastic portion adopts a curved S-shaped curved portion; And / or, the shaft elastic part and the anchoring member are made integrally; And / or, the rod width of the axial elastic part is 1 / 3 to 1 / 2 of the rod width of other parts of the anchor.

5. The elastically fixed heart valve device according to claim 1, 2 or 3, characterized in that: Both ends of the axial elastic part are provided with wire drawing holes, and the wire drawing holes allow the wire drawing 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, characterized in that: The free end of the anchor is provided with an anchor coating; The anchoring membrane is preferably any one of PTFE, ePTFE, TPU, ultra-high molecular weight polyethylene and bovine pericardium, a medical-grade implant material that promotes endothelialization, and more preferably PTFE or ePTFE; The anchoring coating is preferably fixed to the free end of the anchor by winding and heat treatment, or the anchoring coating is preferably fixed to the free end of the anchor by winding an anchoring suture.

7. The elastically fixed heart valve device according to claim 1, 2 or 3, characterized in that: 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.

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

9. The elastically fixed heart valve device according to claim 7, characterized in that: The anchor rod is provided with the shaft elastic part which is integrally arranged thereon.

10. The elastically fixed heart valve device according to claim 9, characterized in that: The axial elastic parts on the two anchor rods are located on the same horizontal plane or are staggered.

11. The elastically fixed heart valve device according to claim 10, characterized in that: 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, wherein H≥1 mm.

12. The elastically fixed heart valve device according to claim 7, characterized in that: 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 outer frame as the connecting ends of the anchor. The outer long rods of the two anchor rods are first gathered inwards from the outflow end to the inflow end and then expanded outwards and then connected or connected through 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 shrinking structure and an outward expansion structure from the outflow end to the inflow end. The shaft elastic part is integrally arranged at the middle part of the outer long rod of the anchor rod.

13. The elastically fixed heart valve device according to claim 1, 2 or 3, characterized in that: The support mechanism also has an inner frame, which is located inside the outer frame and connected to the outer frame; The inner frame comprises: An inner frame body, a hollow cylindrical structure consisting 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, and the connecting rods are used to connect with the far 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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