CN111265333B - Telescopic movable support and intervention type artificial heart prosthesis valve - Google Patents

Abstract

According to the telescopic movable support and the intervention type artificial heart prosthesis valve, the telescopic movable support comprises an upper support, a lower support and a traction piece, wherein the upper support comprises an upper support 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, a plurality of straight rods and a plurality of connecting pieces; traction piece one end links to each other with the straight-bar, the other end passes straight cover, upper strata support wall is radius platform form, a plurality of straight covers set up respectively on upper strata support wall, be provided with the linear slideway of the outside indent of intercommunication in the straight cover, be provided with a plurality of recesses on the linear slideway inner wall, the extension line of a plurality of straight covers crosses on the same point of upper strata support wall axis, lower floor's support wall radius platform form, a plurality of straight-bars set up on lower floor's support wall corresponding to straight cover respectively, the straight-bar has the sand grip, be provided with a plurality of buckles on the outer wall of sand grip, lower floor's support is connected or the separation with lower floor's support, realize the change of distance between upper strata support tip and the claw ear.

Description

Telescopic movable support and intervention type artificial heart prosthesis valve

Technical Field

The invention belongs to the field of medical instruments, and particularly relates to a telescopic movable support and an intervention type artificial heart prosthesis valve.

Background

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.

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, the surgical operation mortality rate is high, and 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.

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. The chordae tendineae are hooked and grabbed to excessively lift apical muscle, which affects normal contraction and relaxation of the ventricle.

The axial height of the prosthetic valve in the existing design is fixed, the sizes of the ventricles of patients are different, and the lengths of chordae tendineae are also different. When the positioning anchoring elements except the hook are normally installed and work, the chordae tendineae of a patient with short chordae tendineae are excessively hooked and grabbed, and the apical muscle is excessively lifted, so that the heart cannot be dilated to a normal state, and the blood ejection function of the heart is influenced.

3. 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.

Disclosure of Invention

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

The invention provides a telescopic movable support which is characterized by comprising an upper support, a lower support and a plurality of straight sleeves, wherein the upper support comprises an upper support 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, a plurality of straight rods and a plurality of connecting pieces; and a traction part, one end of which is connected with the straight rod and the other end of which passes through the straight sleeve, wherein the upper layer bracket wall is in an inverted circular truncated cone shape, the straight sleeves are respectively arranged on the upper layer bracket wall, the straight sleeves are internally provided with inward-concave linear slideways communicated with the outside, the inner walls of the linear slideways are provided with a plurality of grooves, the extension lines of the straight sleeves are intersected at the same point of the axis of the upper layer bracket wall, the lower layer bracket wall is in an inverted circular truncated cone shape, the straight rods are respectively arranged on the lower layer bracket wall corresponding to the straight sleeves, and each straight rod is provided with a convex strip matched with the linear slideway, corresponding to a plurality of recesses, be provided with a plurality of convex buckles on the outer wall of sand grip, on a plurality of claw ears evenly set up lower floor's support wall along circumference respectively, the change of distance between upper support tip and the claw ear is realized to upper support and the separation of lower floor's support, and lower floor's support is fixed through being connected of buckle and recess with lower floor's support.

In the telescopic movable support provided by the invention, the telescopic movable support can also have the following characteristics: wherein, upper support wall, lower floor's support wall all are the fretwork form, and upper support wall, lower floor's support wall adopt arbitrary one kind processing mode or the combination of multiple processing mode in tubular product cutting, NiTi silk are woven, the 3D metal printing to make.

In addition, the telescopic movable support provided by the invention can also have the following characteristics: wherein, a plurality of straight cover are evenly distributed along upper support wall circumference, and the quantity of straight cover is 3-6, and the section of straight slide is the T shape.

In addition, the telescopic movable support provided by the invention can also have the following characteristics: wherein, the straight cover sets up at upper strata support wall inboard, perhaps, the straight cover sets up in upper strata support wall outside, perhaps, the straight cover sets up in upper strata support wall, and the straight cover is connected through any one mode in manufacturing, riveting, welding, sewing up and gluing with upper strata support wall.

In addition, the telescopic movable support provided by the invention can also have the following characteristics: the straight rods are uniformly distributed along the circumferential direction of the lower-layer support wall corresponding to the straight sleeves, the number of the straight rods is 3-6, the cross sections of the convex strips are T-shaped, the arrangement of the buckles corresponds to the grooves, the buckles are made of flexible materials, and the upper ends of the straight rods are provided with drawing holes for connecting drawing pieces.

The invention provides an interventional prosthetic heart valve, which is characterized by comprising the following components: a stent, a skirt and a plurality of valve leaflets, wherein the stent comprises a plurality of fixed ears, flanges and a telescopic movable stent, and the telescopic movable stent is the telescopic movable stent in any one of claims 1-5.

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

In addition, in the interventional artificial heart prosthesis valve provided by the invention, the following characteristics can be provided: 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 interventional artificial heart prosthesis valve provided by the invention, the following characteristics can be provided: 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 interventional artificial heart prosthesis valve provided by the invention, the following characteristics can be provided: 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 telescopic movable support and the intervention type artificial heart prosthesis valve, the lower support is movably separated from the upper support, and the lower support moves in the straight sleeve through the straight rod to change the distance between the end part of the upper 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 structural view of a stent body according to 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 jacket 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 view of a combination of arc segments of a lower stent in an embodiment of the present invention;

FIG. 12 is a schematic axial cross-section of a straight rod in an embodiment of the invention;

FIG. 13 is a schematic view of a process of engaging the latch with the latch slot according to an embodiment of the present invention;

FIG. 14 is a schematic illustration of matching in an embodiment of the invention;

FIG. 15 is a schematic view of a straight rod matching a straight sleeve in an embodiment of the invention;

FIG. 16 is a schematic view of a pull hole in an embodiment of the present invention;

FIG. 17 is a schematic view of the connection position of the lower bracket and the lug in the embodiment of the invention;

FIG. 18 is a schematic view of a claw-lug in an embodiment of the invention;

FIG. 19 is a schematic view of a claw-lug in an embodiment of the invention;

FIG. 20 is a schematic view of a claw-lug in an embodiment of the invention;

FIG. 21 is a schematic view of a prosthetic valve according to an embodiment of the present invention in an operational state;

FIG. 22 is a schematic view of the mating positions of the upper and lower holders according to the embodiment of the present invention;

FIG. 23 is a schematic view of the folding of the connecting material as the lower support slides in accordance with an embodiment of the present invention;

FIG. 24 is a schematic view of a prosthetic valve loading in an embodiment of the present invention;

FIG. 25 is a schematic view of an atrial end ring of the outer rod of the second embodiment of the present invention;

FIG. 26 is a schematic view of a bump-like connection according to an embodiment of the present invention;

FIG. 27 is a schematic view of a flange in an embodiment of the invention;

FIG. 28 is a schematic view of an upper support in an embodiment of the invention;

FIG. 29 is a schematic view of a lower support in an embodiment of the invention.

Detailed Description

In order to make the technical means, the creation characteristics, the achievement purposes and the efficacy of the invention easy to understand, the following embodiments are specifically described with reference to the attached drawings.

Examples

The invention relates to an intervention type artificial heart prosthesis valve. As shown in fig. 1 and 2, the interventional prosthetic heart valve of the present embodiment includes a stent body 10, a skirt 20 and a valve leaflet 30.

The stent body 10 (i.e., the supporting and positioning structure of the prosthetic heart valve for supporting the valve leaflets, attaching the skirt, 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 the present invention.

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

For convenience of explanation, the following description of the structural design is given with reference to a mitral prosthetic valve as an example.

For convenience of illustration, all of the structural designs described below have a side adjacent to the atrium referred to as the atrial end and a side adjacent to the ventricle 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 fig. 27 and 28, 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 is D1, the 02 flange may be integrally cut or integrally woven with the 103 upper layer stent in an original form and then manufactured into a 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 layer support 103 is a hollow inverted circular truncated cone as a whole, and is used for supporting the artificial valve leaflet and the skirt and for supporting the diseased native valve leaflet, so that the artificial valve leaflet has enough space to perform the opening and closing movement. In the embodiment, the upper bracket 103 is integrally in the shape of a hollow inverted circular truncated cone.

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.

If the diameter of the atrial end is D2, the diameter of the ventricular end is D2 and the axial height is H1, then 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.

The upper rack 103 includes a connection pad 1031, an upper rack wall 1032, and a plurality of straight pockets 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 appearance of upper strata support wall 1032 is the shape of inversion round platform, and a plurality of straight cover 1033 set up on upper strata support wall 1032 along circumference interval respectively, and the extension line intersection of a plurality of straight covers 1033 is on the same point of upper strata support wall 1032 axis.

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 jackets 1033 are respectively provided on the upper-layer support wall 1032 at intervals in the circumferential direction.

The straight jacket 1033 is disposed inside the upper rack wall 1032.

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

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

In one embodiment, the upper support walls 1032 are cylindrical in shape dividing the cylindrical wall into a plurality of arcuate segments along the cylindrical axis, and the straight sleeve 1033 is a hollow cylindrical rod inserted through the two upper support walls 1032.

The straight sleeve 1033 may have various suitable forms such as a cylindrical form and a square column form.

Preferably, the straight sleeves 1033 are uniformly distributed along the circumferential direction of the upper layer support 103, and the number of the straight sleeves 1033 is 3-6. The cross-sectional size of the outer contour of the straight sleeve 1033 is determined according to the overall size of the final bracket, and the side length or the diameter of the cross-section of the straight sleeve is not more than 3mm, otherwise, the size of the bracket after loading and pressing 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 sleeve 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, the straight jacket 1033 is provided with a T-shaped hollow section having a T-shaped cross section. In the embodiment, the straight sleeve 1033 is a hollow cylindrical rod with a trapezoidal cross section, a T-shaped channel is arranged in the middle of the straight sleeve 1033, and a plurality of grooves 10331 perpendicular to the axis of the straight sleeve 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 area of the straight sleeve 1033.

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

In one embodiment, the recess 10331 is a square groove in the hollow region of the straight sleeve 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 jacket 1033.

As shown in fig. 10, the lower bracket 104 is formed by combining a plurality of hollow arc bracket segments 1048. It is used for bearing the artificial valve leaf and the skirt. The atrial end is free and the ventricular end is connected to the claw 105. The bracket segment 1048 can be understood as a part of a bracket similar in structure to the upper bracket 103 and integrally formed in an hollowed-out inverted truncated cone shape.

As shown in fig. 11(a), several stent segments 1048 themselves cannot be directly connected to form a complete underlying stent 104. However, the connecting members 1045 may be sewn and adhered between the frame segments 1048 to connect the segments to each other to form the complete lower frame 104 as shown in fig. 11 (b). The connecting member 1045 is made of a flexible material, and may be made of a polymer material having a sealing function or a biological pericardial tissue similar to the skirt 20. The connecting material may extend directly from the skirt 20 attached to the surface of the lower layer of the stent 104, or may be separately sewn, glued, etc. as an assembly.

The connecting member 1045 is made of a flexible material, and may be made of a polymer material having a sealing function or a biological pericardial tissue similar to the skirt 20. The connecting member 1045 is a member for connecting the support segments, and it makes up for the gap between the segments, so that the connected lower support is also in a complete circular truncated cone shape. The shape of the connector should be complementary to the shape of each segment. For example, as shown in fig. 11, a trapezoidal gap between the two adjacent bracket segments is formed between the two adjacent bracket segments, and the connecting member 1045 between the two bracket segments is a trapezoid with a high shape, an upper shape and a lower shape. The connecting material may extend directly from the skirt 20 attached to the surface of the lower layer of the stent 104, or may be separately sewn, glued, etc. as an assembly.

As shown in fig. 10, the lower bracket 104 is movably disposed at the lower portion of the upper bracket 103 and includes a plurality of bracket segments 1048 and a plurality of connecting members 1045.

The bracket segment 1048 comprises two lower bracket walls 1042 and a straight bar 1041 disposed between the two lower bracket walls 1042.

The lower holder wall 1042 is in a mesh form and is a main part constituting the lower holder 104.

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 wall 1042 is manufactured in a manner similar to the flange 102 by any one or a combination of a plurality of processing manners selected from split/integral tube cutting, NiTi wire knitting, 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.

After the connecting members 1045 connect the stent segments 1048 to form the complete lower stent 104, as shown in fig. 29, the diameter of the atrial end is D3, the diameter of the ventricular end is D3, and the axial height is H2, then D3 is 20mm or more and is 50mm or less, D3 is 20mm or more and is 50mm or less, and H2 is 10mm or more and is 80mm or less. In the embodiment, the lower bracket 104 is hollow cylindrical as a whole.

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

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 the 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 has a convex part to make the cross section in an i-shape. The convex part is matched with the straight sleeve 1033, and the convex area of the straight rod 1041 is inserted in the straight sleeve 1033 in a seamless mode.

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. 12, a plurality of convex buckles 10411 are arranged on the outer wall of the straight rod 1041 at intervals corresponding to the plurality of grooves 10331, and the buckles 10411 are convex rings on the convex region of the straight rod 1041. The clip 10411 is made of a flexible material.

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. 13 and 14, the clip 10411 has a certain softness and elasticity, and can be compressed to shrink flat in the circumferential direction to pass through the non-recessed region 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 convex area 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 and 16, the pulling hole 10412 is a circular hole at the atrial end edge of the convex region of the straight rod 1041. The pulling holes 10412 are penetrated with pulling ropes 50 as shown in fig. 21 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 the embodiment, the pulling member 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.

As shown in fig. 15, the straight sleeve 1033 is connected and matched with the outer convex part of the straight rod 1041, and the connection between the two is completed.

The matching mode of the straight sleeve 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. 26, 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 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 through the connection of the buckle 10411 and the groove 10331.

As shown in fig. 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. 17, 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.

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. 18, 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 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. 19, 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. 20, 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. 21, 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 the right side shows the state where the lower holder grips the chordae tendineae and is coupled to the upper holder.

The working state of the prosthetic valve of this embodiment in the heart is shown in fig. 21, and the following brief description of the conventional functions of its components is provided:

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 sheath 1033 and wound in the hole 10412 as shown in fig. 13, 14 and 21. 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.

This design divides a prosthetic valve into two parts, with the claws 105 gripping the chordae tendineae from the base of the ventricle and not obstructing the flange 102 from riding up against the valve annulus. The chordae tendineae are grabbed from the bottom of the ventricle, the chordae tendineae grabbing difficulty can be reduced, and the risk of chordae tendineae missing grabbing is reduced.

2. The whole bracket has the tendency of inner buckling

As shown in fig. 1 and 3, the whole stent has an inverted trapezoid shape, i.e. the size of the ventricular end is smaller than that of the atrial end, and the stent has an inward buckling trend. Therefore, the size of the stent in a ventricle can be reduced, the interference of the stent on aortic blood ejection is reduced, and the incidence rate of LVOTO is reduced.

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. Referring to fig. 21, 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.

3. The upper and lower layer of the stent can generate the overlapping, DIY prosthetic valve height

By matching the structure and size of the inner and outer rods of the buckle, the relative positions of the upper bracket 103 and the lower bracket 104 are shown in fig. 22 after the upper bracket and the lower bracket are connected. Because the convex region of the straight rod 1041 can slide in the vacant region of the straight sleeve 1033, the height of the prosthetic valve can be changed. During operation, the height of the prosthetic valve is properly adjusted according to the actual length of the patient chordae tendineae, so that the prosthetic valve can be prevented from excessively pulling the chordae tendineae, lifting apical muscle and influencing the normal contraction and relaxation of the ventricle.

Meanwhile, the upper layer stent and the lower layer stent are overlapped, so that the overall height of the stent can be reduced, the size of the stent in a ventricle is reduced, the interference of the stent on aortic ejection is reduced, and the incidence rate of LVOTO is reduced.

As illustrated by the stent structure, the diameter D3 of the atrial end of the lower stent 104 is larger than the diameter D2 of the ventricular end of the upper stent 103, so that when the atrial end of the lower stent 104 passes the ventricular end of the upper stent 103, as shown in FIG. 23, the flexible connecting material 1045 can be folded to temporarily reduce the size of D3. That is, when the stent is loaded, the connector may be folded in half, folded in three, or folded in four along its axis in advance to temporarily reduce D3 to less than D2 so that the atrial end of the lower stent 104 may have passed the ventricular end of the upper stent 103. As the lower bracket 104 slides, the folded connecting member is gradually unfolded, D3 becomes larger, and the folded connecting material is restored.

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.

The specific implementation mode is as follows:

1. and (3) loading the prosthetic valve:

as shown in fig. 24, 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.

Second, the upper bracket 103 and the lower bracket 104 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.

When the traction rope passes through the vacant region of the straight sleeve 1033, the traction rope possibly leaks from the T-shaped vacant region, 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. 25, a circular ring can be arranged at the atrium end of the straight sleeve 1033, which can be made of metal, plastic and the like, and can be fixed by welding, sticking and 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.

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 bracket 103 are ensured to complete the positioning and anchoring functions, the traction rope is pulled to guide the lower layer bracket 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.

Effects and effects of the embodiments

According to the telescopic movable support and the intervention type artificial heart prosthesis valve related to the embodiment, because the lower support is movably separated from the upper support, the lower 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 support and the claw lug, so that the claw lug can conveniently grab the chordae tendineae, and the grabbing difficulty can be reduced.

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 telescoping mobile stand, comprising:

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, a plurality of straight rods and a plurality of connecting pieces; and

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

wherein the upper layer bracket wall is in an inverted circular truncated cone shape, a plurality of straight sleeves are respectively arranged on the upper layer bracket wall, inwards concave linear slideways communicated with the outside are arranged in the straight sleeves, a plurality of grooves are arranged on the inner walls of the linear slideways,

the extension lines of the plurality of straight sleeves are intersected at the same point of the axial line of the upper layer bracket wall,

the lower layer bracket wall is in an inverted circular truncated cone shape, a plurality of straight rods are respectively arranged on the lower layer bracket wall corresponding to the straight sleeves,

the straight rod is provided with a convex strip matched with the linear slideway, a plurality of convex buckles are arranged on the outer wall of the convex strip corresponding to the plurality of grooves,

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

through the upper support with the connection or the separation of lower floor's support, realize the upper support tip with the change of distance between the claw ear, the upper support with lower floor's support pass through the buckle with the recess is connected and is fixed.

2. The telescoping mobility leg as described in claim 1, wherein:

wherein the upper layer bracket wall and the lower layer bracket wall are both hollow,

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 telescoping mobility leg as described in claim 1, wherein:

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

the section of the linear slideway is T-shaped.

4. The telescoping mobility leg as described in claim 1, wherein:

wherein the straight sleeve is arranged at 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, adhering and bonding.

5. The telescoping mobility leg as described in claim 3, wherein:

wherein a plurality of straight rods are uniformly distributed along the circumferential direction of the lower layer bracket wall corresponding to the straight sleeves, the number of the straight rods is 3-6, the cross section of each convex strip is T-shaped,

the arrangement of the buckle corresponds to the groove, the buckle is made of flexible materials,

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

6. An interventional prosthetic heart valve, comprising:

a stent, a skirt and a plurality of valve blades,

the bracket comprises a plurality of fixed lugs, a flange and a telescopic movable bracket,

wherein, the telescopic movable support is the telescopic movable support in any one of claims 1 to 5.

7. The interventional prosthetic heart valve of claim 6, wherein:

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

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

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

8. The interventional prosthetic heart valve of claim 6, 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 interventional prosthetic heart valve of claim 6, wherein:

wherein 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 arranged on the big end,

the fixing ear is provided with a protruding structure and is arranged in the delivery device and used for fixing the prosthetic valve,

the fixing lugs are uniformly distributed on the circumferential direction of the end part of the flange, the fixing lugs are in any one of a round shape, a square shape and a star shape,

the fixing lugs are connected with the flanges in any one mode of riveting, welding, sewing and adhering.

10. The interventional prosthetic heart valve of claim 6, 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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