CN111265332B - Artificial heart prosthesis valve - Google Patents

Abstract

The artificial heart prosthesis valve comprises a support body, a skirt edge and a plurality of valve leaflets, wherein the support body comprises a separated movable support and a plurality of claw ears; disconnect-type movable support includes the upper support, lower floor's support and tractive spare, the upper support includes upper support wall and a plurality of straight sleeve pipe, lower floor's support activity sets up the lower part at the upper support, including lower floor's support wall, a plurality of straight-bars are vertical setting respectively on upper support wall, be provided with a plurality of recesses on the straight sleeve pipe inner wall, lower floor's support wall is the tube-shape, a plurality of straight-bars are corresponding to the vertical setting of straight sleeve pipe respectively on lower floor's support wall and the tip that exposes lower floor's support wall in upper end, corresponding to a plurality of recesses, be provided with a plurality of convex buckles on the upper end outer wall of straight-bar, lower floor's support removes the change that realizes the distance between upper support tip and the claw ear through the straight-bar upper end in straight sleeve pipe, lower floor's support is fixed through being connected of buckle and recess with upper support.

Description

Artificial heart prosthesis valve

Technical Field

The invention belongs to the field of medical appliances, and particularly relates to a prosthetic heart valve.

Background

The heart is one of the most important organs in the vertebrate body and has the primary function of providing pressure for blood flow to move the blood to various parts of the body. The heart consists of four cavities, namely a left atrium, a left ventricle, a right atrium and a right ventricle. The left atrium and the right atrium and the left ventricle are separated and are not communicated with each other. The atria and the ventricles are provided with valves (atrioventricular valves) which have the function of a one-way valve, namely, the valves control the blood to flow into the ventricles from the atria and cannot flow backwards through opening and closing movement. The valve between the left atrium and the left ventricle is called the mitral valve, and the valve between the right atrium and the right ventricle is called the tricuspid valve. (the valve between the left ventricle and the ascending aorta is called the aortic valve, and the valve between the right ventricle and the pulmonary artery is called the pulmonary valve.)

The mitral/tricuspid valves are each composed of leaflets, annulus, papillary muscles and chordae tendineae. The valve leaflet is the leaflet of the valve which makes the opening and closing movement and is the most main part of the valve. The annulus is a fibrous ring that connects the leaflets to the inner wall of the heart. Papillary muscles are muscle tissues which are longer than the middle part of the inner wall of a ventricle, and a plurality of milky slender biological tissues called chordae tendineae are grown on the papillary muscles. The other end of the chordae tendineae is connected with the valve leaf to fix and draw the valve leaf.

When a valve becomes defective, the heart hemodynamics change and the heart functions abnormally, which is called valvular heart disease.

With the increasing aging of the population, the incidence of valvular heart disease has been increasing in recent years. Studies have shown that the incidence of valvular heart disease is nearly 15% in the elderly population over 70 years of age, and the population is also gradually under-aged.

At present, drug therapy and surgical operation are still the first choice treatment means for patients with valvular diseases, but for patients with severe valvular diseases, such as advanced age, complicated multiple organ diseases, chest opening operation history and poor cardiac function, the drug therapy effect is poor, and the surgical operation death rate is high, so that even part of patients lose the chance of receiving the operation. The interventional therapy of valvular heart disease has the advantages of no need of opening the chest, small wound, small pain, quick recovery and the like, and is favored by more and more patients.

The heart prosthesis valve is an organ which is manufactured artificially, can be implanted into the heart to replace a heart native valve and control the unidirectional flow of blood in each chamber of the heart. At present, heart prosthesis valve interventional operations at home and abroad are not mature, and the prosthesis valve has a plurality of defects in structural design.

In the 50-60 s of the 20 th century, valvular heart disease could be accurately diagnosed due to the application of cardiac catheterization, and at the same time, foreign scholars also developed interventional treatment of valvular heart disease. China's onset of interventional heart disease is late. Both newly developed transcatheter aortic valve replacement (TAVI) and Transcatheter Mitral Valve Replacement (TMVR) were introduced by ge-sambo in 2010 and 2012, respectively.

Because the growth conditions of the mitral valve are the most complicated among the four valves, the replacement treatment of the mitral valve is relatively difficult and the development is slow, and the structural design of the mitral valve prosthesis valve is the most complicated. Because the tricuspid valve is similar to the mitral valve physiological structure, the replacement therapy is relatively slow to develop, and the tricuspid prosthetic valve is mostly evolved from the mitral prosthetic valve structural design.

The positioning and anchoring modes of the prosthetic valves with different structural designs are different. The existing mitral valve/tricuspid valve prosthesis valve designs are provided with structures such as hooks and claw lugs at the ventricular end of the prosthesis valve, and the structures hook and grab the chordae tendineae to anchor the prosthesis valve and prevent the prosthesis valve from falling out of the ventricle to the atrium.

Analysis of a prior art mitral/tricuspid prosthetic valve design that achieves anchoring by hooking chordae tendineae has found at least one of the following disadvantages:

1. the chordae tendineae are erratic and difficult to grasp

The existing mitral valve/tricuspid valve prosthesis valve which achieves the anchoring effect by hooking chordae tendineae, structures such as a hook can only prevent the prosthesis valve from falling off from a ventricle to the ventricle, structures such as a flange are also needed, and the functions of positioning the prosthesis valve, preventing the prosthesis valve from falling off from the atrium to the ventricle and the like are completed by abutting against a native valve ring at the atrium end. When the prosthetic valve with the design is used in an interventional operation, a doctor needs to complete the grabbing of the hook while the flange is abutted and positioned under ultrasonic development.

In the process of systole and diastole, the native valve leaflets of the heart can open and close due to the change of the trans-valve pressure difference between the atrioventricums, and simultaneously, the chordae tendineae connected with the native valve leaflets of the heart are driven to move back and forth in the atrioventricums. Therefore, the end of the chordae attached to the native leaflet can be considered a free end, which is difficult to grasp. Therefore, if the chordae tendineae are grabbed from the end fixedly connected with the inner wall of the ventricle, the grabbing difficulty can be reduced.

2. LVOTO (left ventricular outflow track occlusion) is produced following mitral valve prosthesis intervention.

Prosthetic valves of prior designs generally have a larger outer profile than the native valve annulus to ensure adequate radial support for the valve stent to anchor in the heart. The larger the diameter of the stent is, the larger the area of the artificial valve leaflet is, the larger the height required by the artificial valve leaflet to open and close is, and the larger the height of the stent is. If the height under the valve of the artificial valve support is too high, the native heart structure and the heart function can be influenced, the rupture of the chordae tendineae occurs, the heart tissue abnormality such as papillary muscle is touched, the obstruction of the left ventricular outflow tract is easily caused, and the adverse postoperative influence is induced.

3. Traditional support formula support as an organic whole is mostly laser cutting tubular product or wire and weaves and form, and the holistic material of support, wall thickness, intensity etc. are roughly the same. When the stent is inserted into the heart, the mechanical properties of the rest parts are overlarge except the key parts playing a supporting role, but the contraction of the heart is influenced, and the fatigue property of the stent is reduced.

Disclosure of Invention

In order to solve the above problems, an object of the present invention is to provide a prosthetic heart valve.

The invention provides a prosthetic heart valve, which is characterized by comprising a bracket body, a plurality of fixing lugs, a flange, a separated movable bracket and a plurality of claw lugs, wherein the fixing lugs are arranged on the bracket body; the skirt edge is arranged on the flange and the separated movable support; and a plurality of valve blades arranged on the separated movable support, wherein the separated movable support comprises an upper support, a lower support and a traction part, the upper support comprises an upper support wall and a plurality of straight sleeves, the lower support is movably arranged at the lower part of the upper support and comprises a lower support wall and a plurality of straight rods, one end of the traction part is connected with the straight rods, the other end of the traction part penetrates through the straight sleeves, the upper support wall is cylindrical, the straight sleeves are respectively and vertically arranged on the upper support wall, a plurality of grooves are arranged on the inner walls of the straight sleeves, the lower support wall is cylindrical, the straight rods are respectively and vertically arranged on the lower support wall corresponding to the straight sleeves, the upper end of each straight sleeve is exposed out of the end part of the lower support wall, a plurality of claw lugs are respectively and uniformly arranged on the lower support wall along the circumferential direction and correspond to the grooves, a plurality of convex buckles are arranged on the outer wall of the upper end of the straight rods, the lower support moves in the straight sleeves through the upper ends of the straight rods to realize the change of the distance between the end parts of the upper support and the claw lugs, the lower layer support and the upper layer support are fixed through the connection of the buckles and the grooves.

In the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: wherein, upper support wall, lower floor's support wall all are fretwork cylindricly, and the diameter is the same, and upper support wall, lower floor's support wall adopt arbitrary one kind processing method or the combination of multiple processing method in tubular product cutting, NiTi silk are woven, the 3D metal printing to make.

In addition, in the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: wherein, the straight sleeve pipe is cylindric or square column, and a plurality of straight sleeve pipes evenly distributed along upper strata support wall circumference, and the quantity of straight sleeve pipe is 3-6.

In addition, in the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: wherein, straight sleeve pipe sets up at upper strata support wall inboard, perhaps, straight sleeve pipe sets up in upper strata support wall outside, perhaps, straight sleeve pipe sets up in upper strata support wall, and straight sleeve pipe is connected through any one mode in manufacturing, riveting, welding, sewing up the bonding of gluing with upper strata support wall.

In addition, in the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: the plurality of straight rods are uniformly distributed along the circumferential direction of the lower-layer support wall, the number of the straight rods is 3-6, the arrangement of the buckles corresponds to that of the grooves, and the buckles are made of flexible materials.

In addition, in the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: wherein, the upper end of the straight rod is provided with a traction hole for connecting a traction piece.

In addition, in the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: the skirt edges are respectively arranged on the inner sides of the flange, the upper layer support wall or the lower layer support wall, or are respectively arranged on the outer sides of the flange, the upper layer support wall or the lower layer support wall, or are respectively arranged on the inner sides and the outer sides of the flange, the upper layer support wall or the lower layer support wall, and are made of high polymer materials or biological tissue materials.

In addition, in the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: wherein, a plurality of valve blades are arranged on the lower layer bracket wall, and the valve blades are made of biological tissue materials or metal materials.

In addition, in the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: the flange is in a disc shape with a large upper part and a small lower part, the small end of the flange is communicated with the upper layer support wall, the large end is a free end, a plurality of fixing lugs are arranged on the large end, each fixing lug is provided with a protruding structure and arranged in the conveying device and used for fixing the prosthetic valve, the fixing lugs are evenly distributed on the circumferential direction of the end part of the flange, the shape of each fixing lug is any one of a circle, a square and a star, and the fixing lugs and the flange are connected in any one of riveting, welding, sewing and adhering modes.

In addition, in the artificial heart prosthesis valve provided by the invention, the artificial heart prosthesis valve also has the following characteristics: wherein, the claw ear is hook-shaped, one end is connected with the lower part of the outer side of the lower layer bracket wall and is positioned on the same horizontal plane, and the other end is a free end and faces the upper part of the lower layer bracket wall.

Action and Effect of the invention

According to the artificial heart prosthesis valve, the lower layer support is movably separated from the upper layer support, and the lower layer support moves in the straight sleeve through the upper end of the straight rod to change the distance between the end part of the upper layer support and the claw lug, so that the claw lug can conveniently grab the chordae tendineae, and the grabbing difficulty can be reduced.

The structure that upper support and lower floor's support activity are separated has: the flange is completely lapped and the claw ears grasp the tendinous valve leaflets independently, so that the interference generated when the integrated support completes the two activities is avoided (namely if the integrated support is controlled to complete the flange lapping, the claw ears are difficult to grasp the tendinous valve leaflets of the valve leaflets, and if the claw ears of the integrated support are controlled to grasp the tendinous valve leaflets, the dislocation of the flange is easily caused and the flange is easily fallen off.)

In addition, the area of the artificial valve leaflet is in direct proportion to the height required by the opening and closing movement of the valve leaflet, namely, the larger the area of the artificial valve leaflet is, the larger the height of the valve support is, namely, the diameter of the support is reduced, the area of the artificial valve leaflet is reduced, the height required by the opening and closing of the valve leaflet is reduced, and the overall height of the support is reduced. The overall height of the present invention is reduced because as the stent diameter is reduced, the size of the leaflet required is reduced and the corresponding height is also reduced. The invention grasps the valve leaflet chordae tendineae by the claw ears, so that the valve leaflet chordae tendineae are actively attached to the wall of the bracket, while the traditional bracket is attached to the valve leaflet by the wall of the bracket actively due to the larger diameter size. Therefore, the stent has small diameter and small height, and avoids the defects that the native heart structure and the heart function are influenced by overhigh lower height of the valve of the artificial valve stent, the left ventricular outflow tract is easy to be blocked, and the adverse postoperative influence is induced.

Drawings

FIG. 1 is a schematic view of a prosthetic heart valve according to an embodiment of the present invention;

FIG. 2 is a schematic top view of a prosthetic heart valve according to an embodiment of the present invention;

FIG. 3 is a schematic view of a stent structure in an embodiment of the present invention;

FIG. 4 is a schematic view of the structural shape of a flange according to an embodiment of the present invention;

FIG. 5 is a schematic view of the structural shape of one flange in an embodiment of the present invention;

FIG. 6 is a schematic view of the structural shape of one flange in an embodiment of the present invention;

FIG. 7 is a schematic view of an upper layer of the stent in an embodiment of the present invention;

FIG. 8 is a schematic view of the position of the upper bracket to flange connection in an embodiment of the present invention;

FIG. 9 is a schematic axial cross-sectional view of a straight sleeve in an embodiment of the invention;

FIG. 10 is a schematic view of a lower support in an embodiment of the invention;

FIG. 11 is a schematic axial cross-section of a straight rod in an embodiment of the invention;

FIG. 12 is a schematic view of a process of engaging the latch with the latch slot according to an embodiment of the present invention;

FIG. 13 is a schematic diagram of matching in an embodiment of the invention;

FIG. 14 is a schematic view of the connection position of the lower bracket and the claw lug in the embodiment of the invention;

FIG. 15 is a schematic view of a claw-lug in an embodiment of the invention;

FIG. 16 is a schematic view of a claw lug in an embodiment of the invention;

FIG. 17 is a schematic view of a claw lug in an embodiment of the invention;

FIG. 18 is a schematic view of a prosthetic valve according to an embodiment of the present invention in an operational state;

FIG. 19 is a schematic view of a bump-like connection according to an embodiment of the present invention;

FIG. 20 is a schematic view of a prosthetic valve loading in an embodiment of the present invention;

FIG. 21 is a schematic view of an upper layer of the stent according to the second embodiment of the present invention;

FIG. 22 is a schematic view of a lower layer of the bracket according to the second embodiment of the present invention;

FIG. 23 is a schematic view of an atrial end ring of the outer rod of the second embodiment of the present invention;

FIG. 24 is an alternative of the matching position of the upper and lower layer brackets in the second embodiment of the present invention;

FIG. 25 is a schematic view of a flange in an embodiment of the invention;

FIG. 26 is a schematic view of an upper support in an embodiment of the invention;

FIG. 27 is a schematic view of a lower support in an embodiment of the invention.

Detailed Description

In order to make the technical means, creation features, achievement objects and effects of the invention easy to understand, the following embodiments are specifically described with reference to the accompanying drawings.

Example one

As shown in fig. 1 and 2, an interventional prosthetic heart valve includes a stent body 10, a skirt 20 and a leaflet 30.

The stent 10 (i.e., the supporting and positioning structure of the prosthetic heart valve for carrying leaflets, attaching skirts, anchoring and positioning, etc.) is made of a shape memory alloy, such as NiTi (nickel titanium alloy), CuAlNi (copper aluminum nickel alloy), etc. NiTi is preferred in this embodiment.

The skirt 20 (i.e., one or more films attached to the inner surface, the outer surface, or both surfaces of the stent body and having the functions of sealing and preventing perivalvular leakage) is made of a polymer material, such as PTFE (polytetrafluoroethylene) or PET (polyethylene terephthalate). Skirt 20 may also be made of a biological tissue material such as animal pericardium.

The valve leaflet 30 (i.e., an artificial valve leaflet used for opening and closing and controlling blood flow in a single direction in place of a native failure valve leaflet of the heart) may be made of a biological tissue material such as animal pericardium (e.g., porcine pericardium, bovine pericardium, etc.). Or made of various metals (mechanical valve blades), such as stainless steel pipes, magnesium alloy and the like. Biological leaflets are preferred for this embodiment.

In the following description of the structural design of a mitral prosthetic valve, the side near the atrium is referred to as the atrial end, and the side near the ventricle is referred to as the ventricular end.

As shown in fig. 3, the bracket 10 includes a plurality of fixing lugs 101, a flange 102, an upper bracket 103, a lower bracket 104, and a plurality of claw lugs 105.

The fixation ears 101 are protruding structures on the atrial end of the flange 102 that are designed to snap-fit into a structure to which the delivery device is adapted so that the prosthetic valve can be secured in the delivery device, pulled or pushed by the delivery device.

The number of the fixing lugs 101 is multiple, and the number of the fixing lugs is matched with the structural design of the support and the structural design of the conveying device.

The shape of the fixing lug 101 is a circular shape, a square shape, a star shape, or any other shape suitable for fitting. Round holes, square holes and the like can be cut on the extension rod at the end part of the flange 102.

The fixing lug 101 may be formed by cutting the flange 102 integrally from a NiTi pipe, or may be formed separately and then connected to the flange 102 in various suitable forms such as riveting, welding, sewing, and adhering.

The fixing lugs 101 can be arranged at any other suitable positions according to the structural design of the bracket and the conveying device.

Preferably, a plurality of fixing lugs 101 are uniformly distributed on the end part of the flange 102 in the circumferential direction, and the number of the fixing lugs 101 is 3-6.

The ventricular end of the flange 102 is connected with the atrial end of the upper bracket 103, and the atrial end of the flange 102 is provided with a plurality of fixing lugs 101. After the prosthetic valve is implanted in the heart, the flange 102 rests against the native leaflets of the heart and annulus and serves to position and anchor them.

The flange 102 is in a shape of a wide disc, the flange 102 is in a shape of a disc with a large upper part and a small lower part, the small end of the flange 102 is communicated with the upper layer support 103, the large end is a free end, and a plurality of fixing lugs 101 are arranged on the large end.

As shown in FIGS. 25 and 26, if the maximum diameter of the atrial end margin is D1, the maximum diameter of the ventricular end margin is D1, and the diameter of the atrial end margin of the upper layer stent 103 is D2, then D1 is greater than or equal to 30mm and less than or equal to 80mm, D1 is greater than or equal to 20mm and less than or equal to 50mm, D1 is less than D1, and D2 is greater than or equal to D1. 102 the flange has a smooth transition overall without circumferential and axial folds.

The ventricular end of the flange 102 is connected with the atrial end of the upper bracket 103, and the atrial end of the flange 102 is provided with a fixing lug 101. After the prosthetic valve is implanted in the heart, it rests against the native leaflets of the heart and annulus, serving as a location and anchor.

The flange 102 has various structural shapes, and the present embodiment provides the following structural designs, but is not limited to the following structural designs:

as shown in fig. 4, the flange 102 is formed by combining a plurality of small curved rods 1021 which are not connected with each other, are flat and arc-shaped as a whole, and each small curved rod 1021 is formed by a plurality of rings. The small curved rods 1021 are evenly distributed on the edge of the atrium end of the upper layer support 103 in the circumferential direction. The circular ring of the small crank 1021 may also be a square ring, a diamond ring, or other suitable shape. The size of each ring may be consistent or different. In this embodiment, the small curved rods do not interfere with each other, so that the overall flexibility of the flange 102 can be increased, and the flange can be easily compressed and loaded into the conveying device.

As shown in fig. 5, the flange 102 is assembled by a plurality of diamond-shaped grids with different sizes formed by connecting rods 1022 which are staggered with each other. The grid shape can also be round, square and other suitable shapes. The grid sizes may or may not be consistent with each other. In this arrangement, the interconnection between the webs increases the overall stiffness of the flange 102, making it easier to position and anchor the prosthetic valve after implantation.

As shown in fig. 6, the flange 102 includes a plurality of diverging stems 1023 or diverging trees. The cross-sectional shape of each divergent rod can be circular, rhombic, square and other suitable shapes. The diverging stem 1023 may or may not have uniform cross-sectional dimensions in the axial direction.

The flange 102 can be manufactured in various manners, and the present embodiment provides the following manners, but is not limited to the following manners:

as an option, the flange 102 is first machined into a blank by laser cutting the NiTI tube, and then machined into a final shape by heat treatment, shaping, sand blasting, polishing, and other processes.

Alternatively, the flange 102 may be woven from NiTi wire into a preform and then heat-set, sand-blasted, polished, etc. to a final configuration.

Alternatively, the flange 102 may be formed by cutting a portion of the tube and weaving another portion of the tube, and then combining the portions by any suitable connection means, such as welding, riveting, sewing, etc.

Alternatively, the flange 102 may be directly fabricated by techniques such as 3D metal printing.

The connection mode of the flange 102 and the upper bracket 103 is various, and the invention provides the following connection modes, but is not limited to the following connection modes:

alternatively, when D2 ═ D1, the flange 102 may be cut or woven integrally with the upper stent 103 into a preform shape, and then fabricated into the final form by an appropriate processing technique.

Alternatively, when D2 is D1, flange 102 may be manufactured separately from the upper bracket 103 and connected thereto by riveting, welding, sewing, gluing, or other suitable means.

Alternatively, when D2 < D1, flange 102 cannot be directly connected to the upper stent 103, and can be connected by using a material such as a polymer material or a biological tissue as a filler.

Preferably, the present embodiment selects a more flexible design and manufacturing of the flange 102 while ensuring the flange 102 functions properly and completely.

As shown in fig. 7, the upper stent 103 is generally hollow cylinder-shaped, and functions to support the artificial leaflets, skirt, and external support the diseased native leaflets, so that the artificial leaflets have enough space to perform "opening and closing movement". In the embodiment, the upper support 103 is hollow and cylindrical as a whole.

The upper stent 103 is connected to the flange 102 at the atrial end and is free at the ventricular end. As shown in fig. 8, one of the positions of attachment of the upper support 103 to the flange 102.

Assuming that the atrial end diameter is D2, the ventricular end diameter is D2, and the axial height is H1, when the upper stent 103 is in a straight cylindrical shape, D2 is D2. In the embodiment, D2 is more than or equal to 20mm and less than or equal to 50mm, D2 is more than or equal to 20mm and less than or equal to 50mm, and H1 is more than or equal to 10mm and less than or equal to 40 mm. And 103, the upper layer of the bracket is in smooth transition integrally without circumferential and axial folding.

The upper layer bracket 103 is manufactured in a manner similar to the flange 102, and may be manufactured by any one or a combination of a plurality of processing manners selected from split/integral pipe cutting, NiTi wire knitting, and 3D metal printing.

The connection modes of the components of the upper layer bracket 103 are various, and the components can be connected in various suitable modes such as integral manufacturing, riveting, welding, sewing, adhering and the like.

The overall structure of the upper bracket 103 has various shapes, and the present embodiment provides the following structural designs, but is not limited to the following structural designs:

as an option, the upper support 103 may be hollow D-shaped or saddle-shaped. The scheme can make the prosthetic valve better adapt to the anatomical structure shape of the mitral valve. (the anatomical configuration of the human mitral valve is "D" or "saddle") and, in response thereto, the ventricular end of the flange 102 and the lower layer 104 should be adjusted in the same configuration.

As an option, the upper layer stent 103 may be in the shape of an inverted truncated cone with a wide upper part and a narrow lower part, and this scheme can reduce the volume of the prosthetic valve in the ventricle and further reduce the interference to the aorta under the condition that the prosthetic valve is ensured to work normally.

As an option, the upper bracket 103 may be a circular truncated cone with a narrow top and a wide bottom or a bucket with a narrow top and a wide middle.

The upper rack 103 includes a connection pad 1031, an upper rack wall 1032, and a plurality of straight tubes 1033.

The land 1031 is a protruding structure of the atrial end margin of the upper stent 103 that is left for attachment to the flange 102.

According to different connection modes, various structures suitable for connection, such as threaded holes, suture holes, buckles, and the like, can be designed on the connection station 1031.

When the upper bracket 103 is integrally manufactured with the flange 102, the structure of the connecting station 1031 is omitted.

The shape of the connecting pad 1031 is not limited to the square shape in the figure, and may be various suitable shapes such as a circle, a diamond, a bump, and a pit.

The existing bracket mostly adopts a mode of integrally manufacturing a flange and a main bracket, namely, after a metal pipe or a metal wire is integrally woven through laser cutting, the raw material is shaped through heat treatment, so that the raw material forms the respective shapes of the flange and the main bracket. The connecting point of the flange and the bracket is a place with larger deformation, and according to the knowledge of material mechanics, the connecting point is easy to break due to stress concentration, and the actual test also verifies the connecting point.

Therefore, the flange and the bracket main body are connected after being manufactured in a split mode, and the phenomenon that stress concentration breaks can be effectively avoided. The connection mode of the flange and the bracket is various, such as laser welding, riveting and the like. If the connection table is not arranged, the flange is directly welded or riveted on the support ring, the original mechanical property of the support ring is easily damaged, and the performance of the support is influenced, so that the problem can be well solved by the arrangement of the connection table. The connecting table can be a welding point, and can also be tapped to complete riveting, so that the flange and the support body are connected well.

As shown in fig. 7, the connection pad 1031 is disposed at the atrial end of the upper stent 103. The connection pad 1031 may be disposed at any suitable location such as the middle portion, ventricular end, etc. of the upper layer support 103.

I.e. the attachment point of the ventricular end edge of the flange 102 to the upper stent 103 is not limited to only the atrial end edge of the upper stent 103. The proposal can lead the partial area of the prosthetic valve to fall in the atrium, and can reduce the volume of the prosthetic valve in the ventricle and further reduce the interference to the aorta under the condition of not influencing the normal work of the prosthetic valve and the heart.

The upper layer support wall 1032 is in a cylindrical shape, and the plurality of straight sleeves 1033 are vertically arranged on the upper layer support wall 1032 respectively.

The upper rack wall 1032 is in a lattice form, and is a main part constituting the upper rack 103.

The lattice shape of the upper stent wall 1032 is varied and may be in various suitable shapes such as circular, diamond, square, etc.

The number and size of the grids in the upper stent wall 1032 are not fixed, and can be properly adjusted according to the size of the final prosthetic valve.

The cells of the upper stent wall 1032 may be interconnected or partially interconnected during stent fabrication. When the grids are designed to be partially connected, materials such as high polymer materials, biological tissues and the like are needed to be used as filling connectors in the later period, and enough mechanical properties of the prosthetic valve must be ensured.

A plurality of straight tubes 1033 are respectively vertically disposed on the upper rack wall 1032,

the straight tube 1033 is disposed inside the upper rack wall 1032.

Alternatively, the straight sleeve 1033 is disposed outside the upper rack wall 1032.

Alternatively, the straight sleeve 1033 is disposed within the upper rack wall 1032.

In an embodiment, the upper holder walls 1032 are cylindrical, dividing the cylindrical wall into a plurality of arc-shaped segments along the cylindrical axis, and the straight tubes 1033 are hollow cylindrical rods inserted through the two upper holder walls 1032.

The straight tube 1033 may have any suitable shape such as a cylindrical shape or a square column shape.

Preferably, the straight-through tubes 1033 are uniformly distributed along the circumferential direction of the upper layer support 103, and the number of the straight-through tubes 1033 is 3-6. The cross-sectional size of the outer contour of the straight tube 1033 is determined according to the overall size of the final stent, and the length of the side or the diameter of the cross-section of the straight tube should not exceed 3mm, otherwise the size of the stent after loading and crimping is increased.

In the illustrated embodiment, the straight tube 1033 is a hollow post having a cross-section with an outer contour and an inner contour, the outer contour defining dimensions such that the length of the side does not exceed 3mm in the case of a square post and the diameter does not exceed 3mm in the case of a cylinder.

The straight tube 1033 and the upper layer support wall 1032 are connected by any one of integral manufacturing, riveting, welding, sewing, and adhering.

As shown in fig. 7, in the embodiment, the straight casing 1033 is a hollow cylindrical rod with a trapezoidal cross section, a rectangular channel is arranged in the middle of the straight casing 1033, and a plurality of grooves 10331 perpendicular to the axis of the straight casing 1033 are arranged on the inner wall of the channel at intervals, as shown in fig. 9, the grooves 10331 are grooves in the hollow region of the straight casing 1033.

The number of the grooves 10331 on the straight casing 1033 is not fixed, and preferably, the grooves 10331 are uniformly and continuously distributed in all the hollow regions of the straight casing 1033.

In an embodiment, the recess 10331 is an annular square groove in the hollow region of the straight tube 1033.

The size of the groove 10331 is not fixed, but should be slightly larger than the clip 10411 to complete the matching.

Preferably, the grooves 10331 are uniformly and continuously distributed in all hollow regions of the straight casing 1033.

As shown in fig. 10, the lower bracket 104 is movably disposed at the lower portion of the upper bracket 103, and includes a lower bracket wall 1042 and a plurality of straight bars 1041.

A plurality of straight rods 1041 are vertically disposed on the lower bracket wall 1042, respectively.

The lower stent wall 1042 is in a mesh form and is a main part constituting the upper stent 103.

The grid shape of the lower stent wall 1042 is various and can be in various suitable shapes such as circle, diamond, square, etc.

The number and size of the meshes in the lower stent wall 1042 are not fixed, and can be adjusted appropriately according to the size of the final prosthetic valve.

The lower stent 104 is generally cylindrical and is used for supporting the artificial valve leaflets and the skirt. The atrial end is free and the ventricular end is connected to the claw 105.

The lower layer bracket 104 is manufactured in a manner similar to the flange 102, and may be manufactured by any one or a combination of a plurality of processing manners selected from split/integral tube cutting, NiTi wire weaving, and 3D metal printing.

The connection of the components of the lower bracket 104 may be made in various ways, such as by integral manufacturing, riveting, welding, and sewing.

As shown in fig. 27, assuming that the diameter of the atrial end is D3, the diameter of the ventricular end is D3, the total axial height is H2, the height of the connection with the upper layer stent 103 is H3, and when the lower layer stent 104 is in a straight tube shape, D3 is D3. In the embodiment, D3 is more than or equal to 20mm and less than or equal to 50mm, D3 is more than or equal to 20mm and less than or equal to 50mm, and H2 is more than or equal to 10mm and less than or equal to 80 mm. And the lower layer of the bracket 104 is in smooth transition integrally without circumferential and axial folding, and the lower layer of the bracket 104 is in hollow cylindrical shape integrally.

The overall shape of the lower bracket 104 is similar to that of the upper bracket 103, and can be in a shape of a D-shaped column, an inverted round table, a water barrel and the like.

The lower bracket wall 1042 is cylindrical, and a plurality of straight bars 1041 are vertically arranged on the lower bracket wall 1042 corresponding to the straight pipes 1033, respectively, and the upper end of each straight bar is exposed out of the end of the lower bracket wall 1042.

The straight rods 1041 are disposed inside the lower bracket wall 1042.

Alternatively, the straight rod 1041 is disposed outside the lower bracket wall 1042,

alternatively, the straight rods 1041 are disposed within the lower bracket wall 1042.

In an embodiment, the lower bracket wall 1042 divides the cylinder wall into a plurality of arc-shaped pieces along the cylinder axis, and the straight rod 1041 is a cylindrical rod inserted into the two lower bracket walls 1042, and a part of the straight rod extends outward to expose the lower bracket walls 1042.

A plurality of convex buckles 10411 are arranged on the outer wall of the upper end of the straight rod 1041 corresponding to the plurality of grooves 10331.

The height of the extending region of the straight rod 1041 is H3, H3 is more than or equal to 10mm and less than or equal to 40mm, the extending region is matched with the straight sleeve 1033, and the extending section of the straight rod 1041 is inserted into the straight sleeve 1033 in a seamless mode. The straight rod 1041 is matched with the straight sleeve 1033 in shape.

A plurality of straight rods 1041 are uniformly distributed along the circumference of the lower support wall 1042, and the number of the straight rods 1041 is 3-6.

As shown in fig. 11, a plurality of convex buckles 10411 are arranged on the outer wall of the upper end of the straight bar 1041 corresponding to the plurality of grooves 10331, the plurality of buckles 10411 arranged at intervals at the end of the straight bar 1041 correspond to the grooves 10331, and the buckles 10411 are made of a flexible material.

As shown in fig. 10, the clasp 10411 is a convex ring on the overhanging region of the straight rod 1041.

The number of the buckles 10411 on the outward extending area of the straight rod 1041 is not fixed. The catch 10411 should be slightly smaller than the recess 10331 to complete the mating.

As shown in fig. 12 and 13, the clip 10411 has a certain flexibility and elasticity, and can be compressed to be contracted and flattened in the circumferential direction so as to pass through the non-recessed area of the straight sleeve 1033. It can be made of suitable elastic materials such as silica gel and fixed to the overhanging region of the straight rod 1041 by means of adhesion and the like.

The cross-sectional shape of the catch 10411 may be arc, square, wedge, etc. When the cross-sectional shape is square, the edge of the clip 10411 should be chamfered so that the clip 10411 can more easily pass through the non-recessed area of the straight sleeve 1033.

Preferably, 3-6 clasps 10411 are grouped, and the clasps 10411 in each group are uniformly and continuously distributed. On the overhanging region of the straight rod 1041, each group is spaced at a distance not more than 6 groups.

The size of the groove 10331 is not fixed, but should be slightly larger than the clip 10411 to complete the matching.

Preferably, the 10411 snap ring and 10331 snap groove should maintain a clearance fit with a clearance dimension approximately equal to 0.

As shown in fig. 10, the pulling holes 10412 are round holes at the atrial end edges of the overhanging regions of the straight rods 1041. The pulling holes 10412 are penetrated with pulling ropes 50 as shown in fig. 18 to pull the lower layer support 104.

The number, size, shape and position of the pulling holes 10412 are not fixed, and can be modified appropriately according to actual needs, in the embodiment, the number of the pulling holes 10412 on the straight rod 1041 is 2.

In an embodiment, the pulling element is a pulling rope 50, one end of which is connected to the straight rod 1041 through the pulling hole 10412, and the other end of which passes through the straight sleeve 1033.

The straight tube 1033 is sleeved on the extended region of the straight rod 1041 to complete the connection and fixation of the two.

The matching mode of the straight tube 1033 and the straight rod 1041 is various, and the present embodiment provides the following matching modes, but is not limited to the following matching modes:

as an alternative, the catch 10411 may be designed as a "wedge-shaped structure", i.e. the cross-sectional shape of the catch 10411 is triangular. This reduces the pulling force of the clip 10411 through the groove 10331, depending on the advantages of the wedge-shaped structural connection. Preferably, the angle a is 30 to 60.

Alternatively, the buckle 10411 may be designed as a "connection structure shaped like a protruding point of an umbrella handle", as shown in fig. 19, the buckle 10411 is a semicircular protruding point on the outward extending region of the straight rod 1041, and is connected and fixed on the straight rod 1041 through an elastic structure (e.g. a micro spring), and when being pressed by the non-recessed region of the straight sleeve 1033, it will be retracted into the outward extending region of the straight rod 1041. When the inner and outer bars of the clip are matched, the salient point of the clip 10411 meets the groove 10331, the pressure is relieved, and the clip is ejected to complete the clip. Meanwhile, the groove 10331 may be designed as an original annular groove, or as a circular hole matched with the shape and size of the clip 10411.

The straight rod 1041 and the lower bracket wall 1042 are connected by any one of integral manufacturing, riveting, welding, sewing and adhering.

The upper end of the straight rod 1041 of the lower bracket 104 is inserted into the straight sleeve 1033, and the lower bracket 104 and the upper bracket 103 are fixed by the connection of the buckle 10411 and the groove 10331.

As shown in fig. 2 and 3, a plurality of claw lugs 105 are respectively and uniformly arranged on the lower bracket wall 1042 along the circumferential direction, and the claw lugs 105 are in a barb-shaped structure which is connected with the lower bracket 104 and is uniformly distributed along the circumferential direction.

In the embodiment, the claw 105 is hook-shaped, one end of the claw is connected with the lower part of the outer side of the lower bracket wall and is positioned on the same horizontal plane, and the other end of the claw is a free end and faces to the upper part of the lower bracket wall. As background, the talons 105 may capture, hook, and anchor chordae tendineae, which may serve to anchor the prosthetic valve.

As shown in FIG. 14, the attachment points of the claw lugs 105 to the lower stent 104 are not limited to only the ventricular end edges of the lower stent 104. The specific position can be properly adjusted according to the human heart anatomy, other structural designs of the prosthetic valve and the structural design of the delivery device. The present embodiment provides the following options for the location of the connection point, but is not limited to the following options:

the attachment point may be located in the middle or atrial end of the lower stent 104, as an alternative.

Alternatively, the connection points may be disposed partially on the ventricular end edge and partially on other portions of the lower layer of the stent 104, in an alternating arrangement.

③ as an alternative, the connection point may be located on the lower bracket wall 1042.

(iv) optionally, the connection points may be located on grid nodes of the lower support wall 1042.

The number of lugs 105 is not fixed. The present embodiment provides the following number setting schemes, but is not limited to the following number setting schemes:

optionally, the lugs 105 may be disposed one on each of a row of grid cells on the lower support wall 1042.

② optionally, the claws 105 may be distributed in a grid.

Preferably, the number of the claw lugs 105 is not less than 6, and the claw lugs are uniformly distributed in the circumferential direction.

The size of the lug 105 is not fixed. The present embodiment provides the following size setting schemes, but is not limited to the following setting schemes:

as an alternative, the claw 105 is designed as a small-sized claw. I.e., the lug 105 is shorter in length than the length of the mesh of the stent ring 1042 to which it is attached. In this arrangement, the small size of the lugs 105 can be inserted into the grid to which they are attached during loading, thereby reducing overall thickness and making loading into the delivery device easier. At the same time, the mesh can only be sewn to the inner skirt, which otherwise would prevent the claw lugs 105 from being inserted.

As an alternative, the claw 105 is designed as a large-sized claw. The claw lugs 105 are longer than the small claw lugs and longer than the mesh of the stent ring 1042 connected with the small claw lugs, i.e. the large claw lugs cannot be embedded into the mesh connected with the large claw lugs. In this scheme, the big size claw ear because bulky advantage can be more easily, firm snatch chordae tendineae, leaflet, prevents its unhook, has reduced and has snatched the degree of difficulty.

The claw 105 has various designs. The invention provides the following structure designs, but is not limited to the following structure designs:

as an alternative, as shown in fig. 15, the claw lug 105 may be a rod with a curvature, the claw lug 105 is slightly curved, and the free end has a barb, so that the claw lug can hook the chordae tendineae and the valve leaflet with a better gripping force, prevent the chordae tendineae and the valve leaflet from unhooking, and enhance the anchoring force.

Secondly, as an option, as shown in fig. 16, the claw lugs 105 are straight rods, so that shaping treatment is not needed, the manufacturing difficulty is low, and the cost is low. And if the claw lugs 105 are straight rods, when the whole support is finally pressed into a conveying system for conveying, the pressing difficulty of the claw lugs 105 is low, and the inner wall of the conveyor is scratched little.

③ as an alternative, as shown in fig. 17, the claw-ears 105 are in the shape of a wave bar, which increases the contact area between the claw-ears and the chordae tendineae and between the claw-ears and the leaflets, increases the contact friction force, prevents the chordae tendineae and the leaflets from unhooking, and enhances the anchoring force.

The claw lugs 105 are manufactured and connected in a manner similar to that of the lugs 101, the flanges 102 and the like, and can be connected in a suitable manner after being manufactured by split/integral pipe cutting, NiTi wire weaving, 3D printing and the like.

Preferably, the surface of the claw 105 is roughened in the form of knurling or the like to increase its gripping power.

The skirt 20 includes skirts respectively disposed at the inner sides of the flange, the upper-layer hanger wall, and the lower-layer hanger wall.

Alternatively, skirt 20 comprises a skirt disposed outboard of the flange, the upper hanger wall, or the lower hanger wall, respectively.

Alternatively, the skirt 20 comprises skirts disposed inboard and outboard of the flange, the upper hanger wall or the lower hanger wall, respectively.

The skirt 20 is made of a polymer material or a biological tissue material.

A plurality of leaflets 30 are disposed on the underlying stent wall,

the leaflet 30 is made of a biological tissue material or a metal material.

The prosthetic valve of this embodiment is operated in the heart as shown in fig. 18, in which the left side shows the state where the lower holder is separated from the upper holder and the claws grip the chordae tendineae, and in which the right side shows the state where the lower holder has gripped the chordae tendineae and is coupled to the upper holder.

The general function of its components is briefly described as follows:

the flange 102 is abutted and attached to the valve annulus BY to form upper limit, so that the prosthetic valve is prevented from falling out from the atrium to the ventricle.

The claw lugs 105 grab the chordae tendineae JS and even part of the end parts of the valve leaflets to form lower limit, so that the prosthetic valve is prevented from being separated from the ventricle to the atrium.

Thirdly, according to the structural design introduction of each component, skirt edges 20 are attached to proper positions of the brackets (the inner and outer surfaces of the flange, the inner and outer surfaces of the upper bracket and the inner and outer surfaces of the lower bracket). The contour, shape and size of each component are adjusted according to actual conditions, so that the skirt edge 20 is tightly attached to the valve annulus BY, the sealing effect is achieved, and the postoperative valve periphery leakage is prevented. The skirt 20 can be attached by suturing or adhering a surgical thread to the support rod. Preferably surgical suture.

Fourthly, the artificial valve leaflet 30 is carried on the upper layer support 103 or the lower layer support 104, and the sizes of the artificial valve leaflet 30 and the support 10 are adjusted according to the actual situation. The artificial leaflet 30 can be attached by sewing or adhering it to the stent rod with a surgical thread, or by sewing or adhering the artificial leaflet 30 to the skirt 20.

The lower support 104 has a function of carrying the artificial leaflet 30, and in the embodiment, the artificial leaflet 30 is sewn to the lower support 104. The specific suturing method and method should be designed according to the material, shape and size of the valve leaflet. For example, the fixed end of the artificial leaflet 30 may be sutured along a suitable stent rod of the lower stent 104 using a suture thread. But it is required to ensure that the heights of the fixed ends of the plurality of artificial leaflets 30 at the same position are on the same axis.

According to the structural design and the attachment method of the skirt edge 20 and the artificial valve leaflet 30, the bracket 10 can be perforated or provided with other suitable structures which are beneficial to the attachment of the skirt edge 20 and the artificial valve leaflet 30 under the condition of not influencing the normal work of the prosthetic valve.

Innovation point

1. Matching buckle of inner and outer rods of buckle

After the upper stent 103 and the lower stent 104 are released in the heart, the lead 50 from the delivery device is passed through the hollow region of the straight sleeve 1033 and wound in the hole 10412 as shown in fig. 11, 12 and 18. By pulling the pulling rope 50, the buckles 10411 and the grooves 10331 are in correct one-to-one correspondence, and the connection between the upper bracket 103 and the lower bracket 104 is completed.

In this embodiment, the prosthetic valve is divided into two parts, and the claws 105 can grab the chordae tendineae from the bottom of the ventricle without obstructing the flange 102 from riding up against the valve annulus. The chordae tendineae M are grabbed from the bottom of the ventricle, so that the chordae tendineae grabbing difficulty can be reduced, and the risk of missing grabbing the chordae tendineae is reduced.

2. The mechanical properties of the upper and lower layer brackets can be different

By using medical means, after the actual working condition of the heart of a patient is known, a support structure which is suitable for combination can be designed so as to better complete interventional therapy.

For example, if the upper layer of the bracket needs to complete the supporting function, it needs to have certain strength and rigidity to obtain enough anchoring force; the lower layer of support plays the roles of bearing the artificial valve leaflets, grabbing the chordae tendineae and the native valve leaflets, and the majority of the lower layer of support is positioned in the middle of the left ventricle, so that the strength and the rigidity required by the lower layer of support are smaller than those of the upper layer of support. If according to the prior art, the integrated bracket is difficult to find out different strengths and rigidities of all parts, and after the bracket is designed in a split mode, the manufacturing of different strengths and rigidities of different parts can be easily completed.

3. Preventing LVOTO:

the area of artifical leaflet and the required height of leaflet start and stop motion are directly proportional, and the area of artifical leaflet is big more promptly, and valve support height is big more, and the support diameter reduces promptly, and the area of artifical leaflet reduces, and the required height that the leaflet opened and shut reduces, and the whole height of support reduces. The overall height of the present invention is reduced because as the stent diameter is reduced, the size of the leaflet required is reduced and the corresponding height is also reduced. As shown in fig. 18, the present invention relies on the claws to grasp the leaflet chords and allow them to actively abut the stent wall, whereas the conventional stent relies on a larger diameter size to allow the stent wall to actively abut the leaflets. Therefore, the stent has small diameter and small height, and avoids the defects that the native heart structure and the heart function are influenced by overhigh lower height of the valve of the artificial valve stent, the left ventricular outflow tract is easy to be blocked, and the adverse postoperative influence is induced.

The specific implementation mode is as follows:

1. and (3) loading the prosthetic valve:

as shown in fig. 20, the delivery device is basically composed of Tip head, pulling rope, sheath, fixing ear and fixing head, besides the components shown in the figure, there are conventional components such as manual or electric handle, catheter, guide wire, etc., which are not explained in this embodiment.

The loading of the prosthetic valve is carried out in ice-water bath below 5 ℃ in vitro.

The upper bracket 103 and the lower bracket 103 are connected using a traction rope emitted from the loading tool.

Thirdly, the prosthetic valve is compressed to a smaller size through a special loading tool and a special loading method, the fixing lug 101 is clamped and embedded in the fixing lug clamping hole, and the prosthetic valve is completely wrapped in the sheath tube by dragging the fixing head.

Fourthly, the sheath tube is filled with normal saline and the like, the air in the sheath tube is emptied, and then the sheath tube is pushed to be completely attached to the Tip head, so that the sealing effect is achieved.

After loading is completed, the prosthetic valve is delivered to the diseased valve site along the femoral vein by traction of the guidewire, and release begins.

Alternatively, the upper stent 103 and the lower stent 104 may be loaded in two sheaths, respectively, while ensuring that the overall diameter of the delivery device is smaller than the diameter of the femoral vein. The two sheath tubes can be arranged in front and back and can also be coaxially sleeved and embedded. In this solution, the upper support 103 and the lower support 104 each require a fixed head to fix and push their movement. Accordingly, a structure similar to the fixing lug 101 may be provided on the straight rod 1041.

Optionally, in the case of a patient with a femoral vein of too small diameter or for other reasons, the prosthetic valve may be released transapically, and other structural designs such as the leaflet suture direction of the prosthetic valve may be adapted accordingly.

2. The prosthetic valve release process:

after the prosthetic valve is conveyed to the bottom end of the ventricle, the control handle withdraws the sheath tube, and the lower layer bracket 104 and the claw lugs 105 are completely released. The claws 105 are adjusted to grip the chordae tendineae by pulling the pull cord, or the like.

Alternatively, only a portion of the area of the claws 105 and the lower support 104 may be released, and after the chordae tendineae have been caught, the entire area may be released.

Secondly, the sheath is continuously withdrawn, and the upper bracket 103 and the flange 102 are released at proper positions.

And thirdly, after the flange 102 and the upper layer support 103 are ensured to complete the positioning and anchoring functions 2, the traction rope is pulled to guide the lower layer support 104 to be matched and buckled, and the traction degree of the prosthetic valve to the chordae tendineae can be adjusted according to actual conditions.

And fourthly, after the combination of the prosthetic valve is finished, withdrawing the traction rope and the conveying system, and enabling the prosthetic valve to start to work normally.

As an alternative, a reverse release method may be adopted, that is, the sheath and the like are designed to be withdrawn forward, the flange 102 and the upper layer stent 103 are released, after the positioning and anchoring are completed, the sheath is withdrawn forward, the lower layer stent 104 and the claw ears 105 are released, the grabbing of the chordae tendinae is completed, and finally the pull rope is pulled to complete the combination of the prosthetic valve.

Example two

The other structures in this embodiment are the same as those in the first embodiment, except that the structures of the straight sleeve and the straight rod are different from those in the first embodiment.

The straight sleeve 2033 is provided with a T-shaped hollow area having a T-shaped cross section. In the embodiment, the straight sleeve 2033 is a hollow cylindrical rod with a trapezoidal cross section, a T-shaped channel is arranged in the middle of the straight sleeve 2033, and a plurality of grooves 20331 perpendicular to the axis of the straight sleeve 2033 are arranged on the inner wall of the channel at intervals, as shown in fig. 21, the grooves 20331 are grooves in the hollow area of the straight sleeve 2033.

Preferably, the grooves 10331 are uniformly and continuously distributed in all hollow regions of the straight sleeve 2033.

The groove 20331 should be slightly larger than the catch 20411 to complete the mating.

The straight rods 2041 are cylindrical rods inserted into the two lower bracket walls 1042 and have convex portions to give an i-shaped cross section. The convex part is matched with the straight sleeve 2033, and the convex area of the straight rod 2041 is inserted in the straight sleeve 2033 seamlessly.

A plurality of straight rods 2041 are uniformly distributed along the circumferential direction of the lower support wall 1042, and the number of the straight rods 2041 is 3-6.

As shown in fig. 22, a plurality of convex buckles 20411 are arranged on the outer wall of the straight rod 2041 at intervals corresponding to the plurality of grooves 20331, and the buckles 20411 are convex rings on the convex area of the straight rod 2041. The buckle 20411 is made of a flexible material.

The catch 10411 should be slightly smaller than the recess 10331 to complete the mating.

The top end of the straight rod 2041 is provided with two pulling holes 20412, and the pulling holes 20412 are round holes at the edge of the atrium end of the convex region of the straight rod 2041. The pulling rope is inserted into the pulling hole 20412 to pull the lower layer support 104.

When the traction rope passes through the vacant area of the straight sleeve 2033, the traction rope possibly leaks out of the vacant area of the T shape, and the problem can be solved by adopting the following method:

firstly, a flat hauling rope is selected, the width of the flat hauling rope is larger than the size of an opening of the vacancy area, and the flat hauling rope is prevented from leaking out of the T-shaped vacancy area.

Secondly, as shown in fig. 23, a circular ring may be arranged at the atrial end of the straight tube 2033, which may be made of metal, plastic, or the like, and may be fixed by welding, adhering, or the like. The hauling cable can pass through the circular ring to prevent the hauling cable from leaking out of the T-shaped vacancy area.

As shown in fig. 24, there are three alternatives for the mating positions of the upper and lower layer brackets.

Effects and effects of the embodiments

According to the artificial heart prosthesis valve that this embodiment relates, because lower floor's support and upper support activity separation, lower floor's support passes through the straight-bar upper end and moves the change that realizes distance between upper support tip and the claw ear in straight-tube, has made things convenient for the claw ear to snatch the chordae tendineae, can reduce and snatch the degree of difficulty.

In addition, the height of the stent is effectively reduced by the structure of movably separating the lower stent from the upper stent, and the defects that the native cardiac structure and the cardiac function are influenced due to overhigh lower height of the valve of the artificial valve stent, the left ventricular outflow tract is easy to block, and adverse postoperative influence is induced are avoided.

Further, because traditional support formula support as an organic whole is mostly laser cutting tubular product or wire and weaves and form, the holistic material of support, wall thickness, intensity etc. are roughly the same. When the stent is inserted into the heart, the mechanical properties of the rest parts are overlarge except the key parts playing a supporting role, but the contraction of the heart is influenced, the fatigue property of the stent is reduced, and the defects are avoided by the split stent structure.

The above embodiments are preferred examples of the present invention, and are not intended to limit the scope of the present invention.

Claims (10)

1. A prosthetic heart valve, comprising:

the bracket body comprises a plurality of fixed lugs, a flange, a separated movable bracket and a plurality of claw lugs;

the skirt edge is arranged on the flange and the separated movable support; and

a plurality of valve leaflets arranged on the separated movable support,

wherein the separated movable support comprises an upper layer support, a lower layer support and a traction piece,

the upper layer bracket comprises an upper layer bracket wall and a plurality of straight sleeves,

the lower layer bracket is movably arranged at the lower part of the upper layer bracket and comprises a lower layer bracket wall and a plurality of straight rods,

one end of the traction piece is connected with the straight rod, the other end of the traction piece penetrates through the straight sleeve,

the wall of the upper layer bracket is cylindrical, a plurality of straight sleeves are respectively and vertically arranged on the wall of the upper layer bracket, a plurality of grooves are arranged on the inner wall of each straight sleeve,

the lower layer bracket wall is cylindrical, a plurality of straight rods are vertically arranged on the lower layer bracket wall corresponding to the straight sleeves respectively, the upper ends of the straight rods are exposed out of the end part of the lower layer bracket wall,

the flange is in a disc shape with a big top and a small bottom, the small end of the flange is communicated with the upper layer bracket wall, the big end is a free end, a plurality of fixing lugs are uniformly distributed on the big end in the circumferential direction,

the claw lugs are respectively and uniformly arranged on the lower layer bracket wall along the circumferential direction,

a plurality of convex buckles are arranged on the outer wall of the upper end of the straight rod corresponding to the grooves,

the lower layer support is moved in the straight sleeve through the upper end of the straight rod to change the distance between the end part of the upper layer support and the claw lug, and the lower layer support and the upper layer support are fixed through the connection of the buckle and the groove.

2. The prosthetic heart valve of claim 1, wherein:

wherein the upper layer bracket wall and the lower layer bracket wall are hollow cylinders with the same diameter,

the upper layer support wall and the lower layer support wall are manufactured by adopting any one or combination of multiple processing modes of pipe cutting, NiTi wire weaving and 3D metal printing.

3. The prosthetic heart valve of claim 1, wherein:

wherein the straight sleeve is cylindrical or square column shaped,

the plurality of straight sleeves are uniformly distributed along the circumferential direction of the upper-layer support wall, and the number of the straight sleeves is 3-6.

4. The prosthetic heart valve of claim 1, wherein:

wherein the straight sleeve is arranged on the inner side of the upper layer bracket wall,

or the straight sleeve is arranged on the outer side of the upper layer bracket wall,

or the straight sleeve is arranged in the upper layer bracket wall,

the straight sleeve and the upper layer support wall are connected in any one mode of integral manufacturing, riveting, welding, sewing and pasting.

5. The prosthetic heart valve of claim 3, wherein:

wherein a plurality of the straight rods are uniformly distributed along the circumferential direction of the lower layer bracket wall, the number of the straight rods is 3-6,

the buckle is arranged corresponding to the groove and made of flexible materials.

6. The prosthetic heart valve of claim 3, wherein:

and the upper end of the straight rod is provided with a traction hole for connecting the traction piece.

7. The prosthetic heart valve of claim 1, wherein:

wherein the skirt edges are respectively arranged at the inner sides of the flange, the upper layer bracket wall or the lower layer bracket wall,

or the skirt edges are respectively arranged at the outer sides of the flange, the upper layer bracket wall or the lower layer bracket wall,

or the skirt edges are respectively arranged at the inner side and the outer side of the flange, the upper layer bracket wall or the lower layer bracket wall,

the skirt is made of high polymer materials or biological tissue materials.

8. The prosthetic heart valve of claim 1, wherein:

wherein a plurality of the leaflets are disposed on the lower stent wall,

the valve leaf is made of biological tissue material or metal material.

9. The prosthetic heart valve of claim 1, wherein:

wherein the fixation ears have a protruding structure disposed in the delivery device for securing the prosthetic valve,

the shape of the fixing lug is any one of round, square and star,

the fixing lug is connected with the flange in any one mode of riveting, welding, sewing and pasting.

10. The prosthetic heart valve of claim 1, wherein:

the claw lugs are hook-shaped, one end of each claw lug is connected with the lower part of the outer side of the lower layer support wall and is positioned on the same horizontal plane, and the other end of each claw lug is a free end and faces the upper part of the lower layer support wall.

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