WO2023125684A1

WO2023125684A1 - Prosthetic valve system and method for using same

Info

Publication number: WO2023125684A1
Application number: PCT/CN2022/142902
Authority: WO
Inventors: 章合强; 黄崇敏; 郭月
Original assignee: 吉林启明皓月生物科技有限公司
Priority date: 2021-12-31
Filing date: 2022-12-28
Publication date: 2023-07-06
Also published as: CN118338866A; CN219896030U; CN116459040A; CN116370149A

Abstract

A prosthetic valve system and a method for using same. The prosthetic valve system comprises a prosthetic valve and a delivery system, which cooperate with each other. The prosthetic valve comprises: a stent, a valve leaflet (131) arranged on the stent, and a tectorial membrane (140) fitted to the stent, wherein a blood flow channel is enclosed inside the stent, and the stent has an inflow side and an outflow side, which are opposite each other. The stent comprises: a support portion (110), which is enclosed by a plurality of U-shaped frames (111), wherein an opening of each U-shaped frame (111) faces the outflow side, and side edges of every two adjacent U-shaped frames (111) are adjacent to each other to form a combination column (112), and converge at a top end of the combination column (112); and an annular portion (120), which is a radially deformable mesh structure and is integrally located on the inflow side of the support portion (110).

Description

Prosthetic valve system and method of use

technical field

The present application relates to the technical field of medical devices, in particular to an artificial valve system and its use method.

Background technique

In the prior art, artificial aortic valves can be roughly divided into transcatheter interventional valves and surgically implanted valves. Transcatheter interventional valves have very small wounds and can be implanted without stopping the heart, without extracorporeal circulation and With general anesthesia, the patient recovers quickly, but the interventional valve also has limitations, including but not limited to: relying on structural anchoring, which requires high requirements on the patient's aortic anatomy; since there is no suture, the anti-displacement performance of the interventional valve must be evaluated ;The patient's original valve leaflet cannot be removed before implantation. When the original valve leaflet is opened by the implanted interventional valve, there will be a risk of blocking the coronary artery opening; most interventional valves have the risk of paravalvular leakage; few products It is designed with valve-in-valve (Valve-in-Valve, ViV) function, that is, a new valve is deployed in the failed valve.

Surgical implantable valves include: traditional thoracotomy surgical valves and suture-free (less suture) surgical valves. Among them, traditional thoracotomy surgical valves have the following advantages:

(1) The patient's native valve leaflets can be cut off before implantation to prevent interference with the implanted surgical valve;

(2) Indications can basically cover all forms of valvular diseases;

(3) The valve height is very short, and the risk of blocking the coronary artery opening and damaging the vascular tissue is very small;

(4) Due to the large number of suturing needles, there is no risk of displacement, and there is basically no paravalvular leakage;

Traditional open-thoracotomy valves also have limitations, such as:

(1) The operation requires incision of the sternum and aorta, which will cause great damage to the patient's body, with a large incision (about 20cm), great pain, and slow recovery;

(2) According to the experience of doctors, in the case of extracorporeal circulation and cardiac arrest, traditional surgical valves need about 90 stitches (14 positions, each position has 6 stitches), and the circulatory blocking time usually takes about 1 hour. Studies have shown that longer circulatory blockades have a risk of irreversible brain damage;

(3) Too many stitches will cause damage to the patient's aortic root;

(4) Compared with interventional valves, surgical thoracotomy has higher requirements for the patient's age and physical condition.

There are fewer suture-free (less suture) minimally invasive small incision surgical valve products, which can solve some of the problems caused by more sutures in traditional open-thoracotomy valve surgery.

During minimally invasive small-incision heart valve implantation procedures, a delivery system is often used to help the prosthetic heart valve pass through and implant in the patient. Precisely positioning the prosthetic heart valve within the area, the delivery system is also used to hold the prosthetic heart valve securely in place until the sutures are completed and the sutures are tied.

In the case of some small incision prosthetic valve implantation, the delivery system is connected with a long and thin handle, and the surgeon manipulates the handle to manipulate the valve to its desired implantation position, and then removes the long and thin handle, and sutures the sewing ring to the native The annulus, during which the delivery system remains attached to the prosthetic valve to protect the valve, obstructs the surgeon's view during the suture procedure.

Contents of the invention

Aiming at the problem of artificial valve implantation, an artificial valve and a system for implanting the artificial valve are provided. The delivery system compresses the artificial valve and places it into the target position accurately, which is applied to minimally invasive small incision surgery.

An artificial valve system, the artificial valve system includes an artificial valve and a delivery system that cooperate with each other. A sewing ring on the periphery of the stent, the inside of the stent is surrounded by a blood flow channel, the stent has opposite inflow sides and outflow sides, and the stent includes:

The support part is surrounded by a plurality of U-shaped frames and the opening of each U-shaped frame faces the outflow side, the sides of two adjacent U-shaped frames are adjacent to each other to form a joint column, and the sides of two adjacent U-shaped frames meet to the joint column top of

an annular part, which is a radially deformable grid structure, and is located on the inflow side of the support part as a whole;

The delivery system includes:

a control handle having opposing distal and proximal ends;

The valve buckles, and its periphery has a matching structure corresponding to the supporting part of the artificial valve;

The sleeve is movably arranged on the outer periphery of the valve buckle, and the sleeve can be switched between wrapping and exposing the fitting structure;

When the sleeve is in the state of wrapping the matching structure, the artificial valve is in a loading state where the outflow side is gathered radially inward, and the inflow side is flaring;

When the sleeve is in the state of exposing the fitting structure, the artificial valve is in the radially outward expansion of the outflow side, and the artificial valve is in a release state of a straight cylindrical structure as a whole;

Two transmission parts, nested inside and outside, and the farthest ends are respectively connected to the valve buckle and the sleeve, the proximal ends of the two transmission parts are connected to the control handle, and at least one of them is connected to the control handle. The active cooperation between them is adapted to the state switching of the sleeve.

The following also provides several optional ways, but they are not used as additional limitations on the above-mentioned overall scheme, but are only further additions or optimizations. On the premise of no technical or logical contradiction, each optional way can be carried out independently for the above-mentioned overall scheme Combination can also be a combination of multiple options.

Optionally, a sewing ring is provided on the outer periphery of the stent.

Optionally, the periphery of the stent is surrounded by an annular anti-circumferential leakage part, and the anti-circumferential leakage part is located on the inflow side of the sewing ring.

Optionally, the sewing ring extends along the circumference of the stent and has a wave structure, the part opposite to the inflow side is a trough, and the part opposite to the outflow side is a wave crest, and the trough is in contact with the peripheral leakage prevention part.

Optionally, the sewing ring is on the inflow side of the U-shaped frame, and there is a space between the U-shaped frame and the U-shaped frame.

Optionally, the covering film includes an outer covering film covering the radially outer side of the stent, the anti-circumferential leakage portion includes an expandable material belt and a first part of the outer covering film, and the first part wraps The strip of expandable material.

Optionally, the outer covering film is made of PET material.

Optionally, the inner covering membrane is made of an expandable material, and the expandable material band is integrated with the inner covering membrane.

Optionally, the sewing ring includes a strip of suture material and a second portion of the outer covering film, and the second portion wraps around the strip of suture material.

Optionally, each leaflet has a fixed edge connected to the U-shaped frame and a free edge that cooperates with other leaflets to change the opening degree of the blood flow channel, and the covering film includes an inner covering covering the radial inner side of the stent The outflow side of the inner covering membrane is butted to the fixed edge of the valve leaflet, and both the inner covering membrane and the outer covering membrane are connected to the inflow side of the stent.

Optionally, the inner covering film and the outer covering film are integral membranes, or separate membranes.

Optionally, the expandable material band and the suture material band are independently completely wrapped by the outer covering film, or sandwiched and wrapped between the inner covering film and the outer covering film.

Optionally, the expandable material band is in the form of a band of water-absorbing swellable material that is continuously distributed in the circumferential direction of the stent, or is in the shape of a plurality of blocks arranged at intervals; the annular portion has a grid structure, and the block-shaped water-swellable The materials respectively correspond to the hollow areas of the grid structure.

Optionally, the expandable material band includes a base arranged around the periphery of the stent and a water-absorbing swellable material fixed on the base.

Optionally, threading marks are provided on the sewing ring, and in the peripheral direction of the stent, the threading marks are misaligned with the binding posts.

Optionally, there is a threading mark on the sewing ring, and the threading mark is at a trough position.

Optionally, the valve buckle is columnar, and the fitting structure is an anti-off groove and/or an anti-off post arranged on the outer periphery of the valve buckle.

Optionally, the control handle includes:

A housing, the housing is an installation chamber, and one of the two transmission parts is fixed in the installation chamber;

a moving seat, which is slidably arranged in the installation chamber, and the other of the two transmission parts is fixed to the moving seat;

a gear adjustment mechanism, configured between the moving base and the installation chamber, and restricting the moving base to at least two gears;

The control button is connected with the moving base, and at least a part extends to the outside of the housing.

Optionally, the distal end of the sleeve is a flaring structure, and the opening edge of the flaring structure is provided with a plurality of escape grooves arranged at intervals in the circumferential direction, and the circumferential distribution positions of the escape grooves are the same as the suitable matching structure.

Optionally, the gear adjustment structure includes:

A plurality of card slots arranged at intervals along the axial direction of the housing, the plurality of card slots are arranged on one of the moving seat and the inner wall of the housing;

The elastic tab is arranged on the other one of the moving seat and the inner wall of the housing, and the elastic tab is combined with the corresponding slot when the moving seat is in different positions.

Optionally, two elastic strips are fixed side by side on the moving seat, and one section of each elastic strip protrudes away from each other to form two elastic snap tongues, and the snap slots are in two rows, respectively corresponding to one of the elastic strips. Tongue.

Optionally, a locking piece is movably embedded on the housing, and the locking piece can be switched between two states of interfering with and avoiding the moving seat.

Optionally, an L-shaped limiting groove is provided on the distal side of the moving seat, and the limiting groove includes a longitudinal section extending axially along the housing and a transverse section vertically communicating with the longitudinal section, wherein the The ends of the longitudinal ends are open;

The locking member is respectively located in the transverse section and the longitudinal section under the two states of interfering with and avoiding the moving seat.

Optionally, the delivery system has a length of 300-400mm.

The application also provides a method for using the delivery system, comprising the steps of:

The control handle drives the sleeve to move relative to the valve buckle to expose the valve buckle;

The fitting structure of the valve buckle is combined with the supporting part of the artificial valve;

The driving sleeve of the control handle is in the state of wrapping the matching structure, the outflow side of the artificial valve is gathered radially inward, and the inflow side is flaring;

The control handle driving sleeve is in the state of releasing the adapting structure, the outflow side of the artificial valve breaks away from the adapting structure and expands radially outward, and the artificial valve has a straight cylindrical structure as a whole.

The artificial valve provided by this application is implanted in the body by surgical operation, and the delivery system accurately delivers the artificial valve to the target position after being partially compressed, and is applied to minimally invasive small incision surgery.

Description of drawings

Fig. 1 a is the schematic diagram of the support of artificial valve;

Fig. 1 b is the front view of the support of artificial valve;

Fig. 1c is a schematic diagram of a stent of an artificial valve connected with leaflets;

Fig. 1d is a schematic diagram of a stent of an artificial valve connected with leaflets;

Figure 1e is a schematic diagram of a stent of an artificial valve;

Figure 1f is a schematic diagram of an artificial valve;

Figure 1g is a schematic diagram of an artificial valve;

Figure 1h is a schematic diagram of an artificial valve;

Figure 1i is an exploded view of the artificial valve;

Fig. 1j is a schematic diagram of the anti-peripheral leakage part in the artificial valve;

Fig. 1k is a schematic diagram of the integrated structure of the anti-peripheral leakage part and the inner membrane in the artificial valve;

Figure 2a is a schematic diagram of the delivery system;

Figure 2b is a schematic diagram of the delivery system;

Figure 2c is a sectional view taken along the line A-A in Figure 2b;

Figure 2d is an exploded view of the control handle in the delivery system;

Figure 2e is an exploded view (another perspective) of the control handle in the delivery system;

Fig. 2f is a schematic diagram of the buckle of the valve in the delivery system (the sleeve structure is omitted);

Figure 2g is a schematic diagram of the delivery system starting to load the artificial valve;

Figure 2h is a schematic diagram of the delivery system fully loaded with an artificial valve;

Fig. 2i is a schematic diagram of the delivery system fully loading the artificial valve and locking the locking member;

Fig. 2j is a schematic diagram of the delivery system placing the artificial valve into the native valve annulus;

Fig. 2k is a schematic diagram of the delivery system placing the artificial valve into the native valve annulus, and the sewing ring is fully opened;

Figure 21 is a schematic diagram of the delivery system completely releasing the artificial valve;

Fig. 2m is a schematic diagram of the artificial valve implanted in a human body.

In the figure: 110, supporting part; 111, U-shaped frame; 112, connecting column; 113, connecting end; 114, connecting ear; 115, contact bar; 116, hollow window; 120, ring part; 121, V-shaped frame bar ; 122, deformation release area; 130, leaflet; 131, free edge; 132, fixed edge; 140, covering membrane; 141, inner covering membrane; 142, outer covering membrane; 150, sewing ring; 151, suture material belt; 160. Leakage prevention part; 161. Expandable material belt; 170. Threading mark;

210, control handle; 211, housing; 212, moving seat; 213, gear adjustment mechanism; 214, control button; 215, card slot; 216, elastic tongue; 217, elastic bar; 218, guide structure; Locking part; 220, sleeve; 221, escape groove; 230, valve buckle; 231, adaptation structure; 240, transmission part; 241, inner tube; 242, outer tube;

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all of them. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

In order to better describe and illustrate the embodiments of the application, reference may be made to one or more drawings, but additional details or examples used to describe the drawings should not be regarded as an invention of the application, the presently described implementation limitations on the scope of any of the examples or preferred modes.

It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or intervening components may also exist. When a component is said to be "set on" another component, it may be set directly on the other component or there may be an intervening component at the same time.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which this application belongs. The terms used herein in the specification of the application are only for the purpose of describing specific embodiments, and are not intended to limit the application.

Referring to Fig. 1a and Fig. 1b, a stent for an artificial valve has opposite inflow sides and outflow sides, including:

The support part 110 is surrounded by a plurality of U-shaped frames 111 and the opening of each U-shaped frame 111 faces the outflow side (the dotted line in Fig. 1a is the direction of blood flow), and the sides of two adjacent U-shaped frames 111 are adjacent to each other to form a joint column 112, the sides of two adjacent U-shaped frames 111 converge to the top of the coupling column 112;

The annular part 120 is a grid structure deformable in the radial direction, and is located on the inflow side of the support part 110 as a whole. Corresponds to the turning point on the inflow side in the middle.

The annular portion 120 has a deformable grid structure in the radial direction, and the grid structure is taken as a whole, and it is not strictly required that all parts in the circumferential direction have complete grids.

Since the annular portion 120 has a deformable space in the radial direction, the artificial valve support can be compressed to a certain extent in the radial direction. For surgical operations, the size of the incision can be reduced and the damage to the patient's body can be reduced.

The artificial valve stent of the present application is fixed to the valve annulus by surgical suture, which inherits the advantages of surgical artificial valves, such as extremely low risk of displacement, low risk of blocking coronary arteries, original diseased leaflets can be cut off, wide indications, The valve-in-valve function can be realized (that is, after the valve fails later, a new valve can be inserted into the valve).

In one of the embodiments, as shown in Fig. 1a, Fig. 1b, and Fig. 2h, the support has a relative loaded state and a released state, wherein:

In the loaded state, the outflow side of the stent is gathered radially inward, and the inflow side of the stent is flaring;

In the released state, the outflow side of the stent expands radially outward, and the stent as a whole has a straight cylinder structure.

In the released state, the starting point of radial outward expansion of the outflow side of the stent is the loaded state, and the process of outward expansion is essentially a process of restoring the stent to a straight cylindrical structure.

The stent has a relative loading state and a releasing state, and correspondingly, the artificial valve also has a corresponding loading state and a releasing state, wherein:

In the loaded state, the outflow side of the artificial valve gathers radially inward, and the inflow side of the artificial valve is flaring;

In the released state, the outflow side of the artificial valve expands radially outward, and the artificial valve is in a straight cylindrical structure as a whole.

In Fig. 1a and Fig. 1b, the stent of the artificial valve is in the released state, and the stent has an overall upper straight cylinder structure. In Fig. 2h, the stent of the artificial valve is in the loaded state, and the sides of the U-shaped frame 111 of the support part 110 are close to each other, forming an inward gathering structure, the annular portion 120 is adaptively flared toward the outflow side.

The stent has an integrated structure and adopts self-expandable and releasable memory materials. For example, a pipe made of nickel-titanium alloy is cut, and then heat-treated to obtain a stent.

The stent of the artificial valve is made of nickel-titanium alloy material, which can be compressed to 16mm in the radial direction, reducing the difficulty of the valve descending to the annulus. The incision length on the patient's body surface can be controlled at 4-6cm to meet the needs of stent placement, which is much smaller than traditional surgical valves. The required incision length of 20 cm is placed, which reduces the number of sutures, saves the blocking time, and reduces the damage to the patient's aortic root.

In addition, the intercostal approach can be selected for the small incision, which avoids the pain caused by the median sternotomy to the patient. In addition, for patients with a small diameter of the sinotubular junction, the difficulty of implantation is reduced.

The stent has an expandable structure and is made of nickel-titanium material, which can be anchored by the radial support force of the stent without the need for balloon expansion, reducing the complexity of the operation.

In one of the embodiments, as shown in Fig. 1a and Fig. 1b, there are three U-shaped frames 111, and the turning part on the inflow side in each U-shaped frame 111 is the connecting end 113, and the annular part 120 passes through the mesh at the corresponding position. The vertices of the lattice structure are fixed to each connection end 113 .

The turning point on the inflow side, that is, the middle position of the bottom of the U-shaped frame 111 is defined as the connection end 113 , and the connection end 113 is fixedly connected to the apex of the grid structure of the annular portion 120 .

In one embodiment, as shown in FIG. 1 a and FIG. 1 b , the frame strength of the U-shaped frame 111 is greater than that of the annular portion 120 .

The outflow end of the valve is the working area of the leaflet, that is, the U-shaped frame 111 is the most direct support when the leaflet 130 moves. The frame strength of the U-shaped frame 111 is greater than that of the annular part 120. At the same time, the U-shaped frame 111 has a higher strength and is less likely to be deformed, reducing swinging, and at the same time reducing the impact on the ring portion 120, thereby enhancing the durability of the bracket.

The grid structure of the annular part 120 mainly plays an anchoring role. Under the premise of ensuring the radial support force, the strength of the frame strips of the annular part 120 is smaller than that of the U-shaped frame 111, which can make the annular part 120 under external pressure. The impact on the U-shaped frame 111 of the supporting part 110 is reduced by itself deforming to comply with the external force.

In order to realize the difference in frame strength, the frame bars of the U-shaped frame 111 can be wider or thicker than the frame bars of the annular part 120. Considering the convenience of processing, preferably, the frame bars of the U-shaped frame 111 can be compared with the The frame bars of the ring portion 120 are wider.

In one embodiment, as shown in FIG. 1 a and FIG. 1 b , the top end of the coupling post 112 is widened in the circumferential direction of the bracket to form a connecting ear 114 adapted to the delivery system.

The connecting ears 114 are used to connect the stent of the artificial valve to the delivery system, so that the stent can be stably installed in the delivery system. The connecting ear 114 can adopt various structures, and besides the substantially rectangular structure shown in Fig. 1a and Fig. 1b , other forms can also be adopted, such as semicircular or radially extending steps.

In one of the embodiments, as shown in Fig. 1a and Fig. 1b, one or more contact strips 115 are arranged between the sides of two adjacent U-shaped frames 111, and the contact strips 115 are surrounded by the joint column 112 where they are located. One or more cutout windows 116 .

The connecting strip 115 forms a connecting structure between the sides of two adjacent U-shaped frames 111, which strengthens the connection strength between the sides of the adjacent two U-shaped frames 111 on the one hand, and does not interfere too much with the sides of the U-shaped frames 111 on the other hand. edge deformation.

During the sewing process, the leaflet 130 has a flanging edge wrapping part of the side of the U-shaped frame 111 , and at least one hollow window 116 is used to accommodate the flanging edge of the leaflet 130 .

In one embodiment, as shown in FIG. 1b , along the axial direction of the stent, the length of the annular portion 120 is L1, the length of the support portion 110 is L2, and L1 is smaller than L2.

The supporting part 110 is used to fix the valve leaflet 130, and has at least an axial length compatible with the valve leaflet 130, while the annular part 120 is used for positioning in the blood vessel and carrying the structure for preventing paravalvular leakage. The valve is sutured on the valve annulus, and the annular part 120 is easy to meet the needs of positioning, and does not require an excessively long axial length. Under the premise, the axial length should be reduced as much as possible to reduce the adverse effect on the tissue at the implantation site.

In one embodiment, as shown in FIG. 1b, L1:L2=1:1.5˜1:3.

In one embodiment, as shown in FIG. 1 a and FIG. 1 b , at least a part of the annular portion 120 in the circumferential direction is a V-shaped frame bar 121 .

The V-shaped frame bar 121 is more likely to deform when subjected to external force, and the angle of the V-shaped clip changes. When valve-in-valve implantation is required, the existence of the V-shaped frame bar 121 makes the annular part 120 receive radial force When the external force acts, it is easier to expand outward in the circumferential direction, which is beneficial to the implantation of the new valve.

When the annular portion 120 expands outward under radial force, the V-shaped frame strip conforms to the external force, reducing the impact on the support portion 110 , that is, reducing the impact on the shape of the leaflet 130 connected to the support portion 110 .

Self-expanding valves and ball-expanding valves can be used as valve-in-valve implants. Since the V-shaped frame strip 121 of the stent can be expanded by external force, after implanting the self-expanding valve, the small incision valve can be stretched without rebounding. It is ensured that the opening area is not affected.

In one embodiment, as shown in Fig. 1a and Fig. 1b, the grid structure of the annular portion 120 is a unit cell arranged along the circumferential direction, and the unit cell is only one circle in the axial direction.

The size of the annular part 120 in the axial direction is relatively short, and only one circle of cells is provided to reduce the density of the cells, so that the annular part 120 is more likely to be deformed when it is subjected to radial external force. There are sutures between the valve and the valve ring, and the ring part 120 is easy to deform without adversely affecting the positioning, and when valve-in-valve implantation is required, it is easier to expand circumferentially, which is beneficial to the implantation of a new valve.

In one embodiment, as shown in FIG. 1a and FIG. 1b , the number of all cells is 9-24, which is an integer multiple of the number of U-shaped boxes 111 .

All the cells are uniformly arranged along the circumference, or at least divided into N groups, where N is the number of U-shaped frames 111, and the number of each group is the same. The number of all cells is 12, and each cell is not strictly a complete circumferentially closed structure, but may be open in the circumferential direction.

In one embodiment, as shown in FIG. 1 b , when the annular portion 120 is in a flattened state, the lines connecting the vertices on the outflow side of the cells are straight lines.

Only part of the cells of the annular portion 120 are connected to the connecting end 113 of the U-shaped frame 111 , and the rest of the cells are not connected to the U-shaped frame 111 . The deformation between the sides of the U-shaped frame 111 and the annular portion 120 is relatively independent.

In one embodiment, as shown in FIGS. 1 a and 1 b , at least one unit cell is a deformation releasing cell opened on the inflow side of the annular portion 120 .

The V-shaped frame bar 121 is the deformation release cell. Under the action of radial external force, the deformation release cell deforms preferentially to comply with the external force, and the remaining circumferentially closed cells deform subsequently.

In one embodiment, as shown in FIGS. 1 a and 1 b , except for the deformation release cell, the other cells are roughly rhombus or hexagon.

The shape of the cell is not a strict geometric shape, and there are local deformations based on the needs of processing, but at least it should meet the requirements of radial contraction and expansion of the scaffold.

In one embodiment, as shown in FIG. 1 a , the number and circumferential positions of the deformation release cells correspond to the binding posts 112 one by one.

The positions of the deformation release cells and the coupling posts 112 correspond one by one. When an external force is applied, the circumferentially expanded parts of the ring portion 120 and the support portion 110 are aligned with each other in the axial direction, and the deformations of the ring portion 120 and the support portion 110 are mutually aligned. There is less restraint between them, that is, when the annular portion 120 expands in the circumferential direction, it will not be restrained by the support portion 110 , and vice versa.

In one embodiment, as shown in FIG. 1 a , the deformation releasing grid is a V-shaped frame strip 121 , and the opening of the V-shaped is facing the inflow side of the annular portion 120 .

The V-shaped opening faces the inflow side of the annular portion 120 , and the V-shaped opening is easier to expand when subjected to radial external force.

Referring to Figure 1e, the present application also provides a stent for an artificial valve, which has opposite inflow sides and outflow sides, including:

The support part 110 is surrounded by a plurality of U-shaped frames 111 and the opening of each U-shaped frame 111 faces the outflow side. The sides meet at the top of the bonding column 112;

The annular part 120 is a grid structure deformable in the radial direction, and is located on the inflow side of the supporting part 110 as a whole. At least a part of the annular part 120 in the circumferential direction is a deformation release area 122. The position of the deformation release area 122 is combined with The inflow side of column 112 is aligned.

Compared with other parts of the annular part 120, the deformation release area 122 is more likely to deform and expand outward when it is radially stressed. Since the valve is implanted in a surgical manner, there is suture between the valve and the annulus, and the annular part The easy deformation of 120 will not adversely affect the positioning, and when valve-in-valve implantation is required, it is easier to expand circumferentially, which is beneficial to the implantation of a new valve.

The position of the deformation release area 122 is aligned with the inflow side of the coupling column 112. When an external force is applied, the circumferential expansion of the ring portion 120 and the support portion 110 are aligned with each other in the axial direction, and the ring portion 120 and the support portion 110 are axially aligned. The deformations of the rings are less restrained by each other, that is, when the annular portion 120 expands in the circumferential direction, it will not be restrained by the supporting portion 110, and vice versa.

When the annular portion 120 expands outward under radial force, the deformation release area 122 complies with the external force, reducing the impact on the supporting portion 110 , that is, reducing the impact on the shape of the leaflet 130 connected to the supporting portion 110 .

In one embodiment, as shown in FIG. 1 e , the deformation release area 122 is a frame structure that can be stretched in the peripheral direction of the stent, and the area surrounded by the frame structure is an open area.

The deformation releasing area 122 adopts a circumferentially stretchable frame structure. When subjected to a radial external force, the frame structure stretches to deform the deformation releasing area 122 . The setting of the open area allows a greater amount of deformation.

In one embodiment, as shown in FIG. 1 e , the frame structure is V-shaped or W-shaped.

The V-shaped frame structure does not require a balloon to expand, and uses the radial support force of the V-shaped frame 121 structure itself to closely fit the patient's native aortic valve ring, which enhances valve stability and reduces paravalvular leakage. The complexity of the operation is reduced.

In one embodiment, as shown in FIG. 1 e , the number and circumferential positions of the deformation releasing regions 122 correspond to the bonding posts 112 one-to-one.

The deformation release area 122 corresponds to the position of the coupling column 112 one by one. When an external force is applied, the circumferential expansion of the annular part 120 and the support part 110 are aligned with each other in the axial direction, and the deformation of the annular part 120 and the support part 110 There is less restraint between them, that is, when the ring portion 120 expands in the circumferential direction, it will not be restrained by the support portion 110 , and vice versa.

The present application also provides an artificial valve, as shown in Fig. 1f, Fig. 1g, Fig. 1h, and Fig. 1i, including:

The stent encloses a blood flow channel inside the stent;

A plurality of leaflets 130, each leaflet 130 has a fixed edge 132 connected to the U-shaped frame 111 and a free edge 131 that cooperates with other leaflets 130 to change the opening degree of the blood flow channel;

Covering film 140, covering the inner and/or outer sides of the stent in the radial direction;

The sewing ring 150 is fixed on the outer periphery of the stent.

The covering film 140 covers the inside, or outside, or both inside and outside of the stent in the radial direction.

After being implanted in the human body, the sewing ring 150 is used for suturing with the valve ring to fix the position of the valve.

In one embodiment, as shown in FIG. 1 f , an annular anti-peripheral leakage portion 160 is surrounded on the outer periphery of the stent, and the anti-peripheral leakage portion 160 is located on the inflow side of the sewing ring 150 .

As shown in FIG. 1f, the sewing ring 150 extends along the circumferential direction of the stent and has a wave structure. The part opposite to the inflow side is a wave trough, and the part opposite to the outflow side is a wave peak.

After the valve is implanted, on the one hand, rely on the expandable structure of the stent itself for anchoring, and on the other hand, suture between the sewing ring 150 and the valve ring to ensure the stability of the valve after implantation. To block the gap between the valve ring and the sewing ring 150, prevent blood from flowing through the gap.

In one embodiment, as shown in FIG. 1 f , the sewing ring 150 is located at the inflow side of the U-shaped frame 111 , and there is a space between the U-shaped frame 111 and the U-shaped frame 111 .

On the one hand, the spacer facilitates the sewing of the covering film 140 and the valve leaflet 130, and on the other hand, it also gives the sewing ring 150 a certain deformation space, that is, when the artificial valve is compressed and enters the delivery system, the deformation of the sewing ring 150 will not damage the valve leaflets. 130 brings greater deformation pressure.

In one of the embodiments, as shown in Fig. 1f, Fig. 1g, Fig. 1h, and Fig. 1i, the covering film 140 includes an outer covering film 142 and covers the radially outer side of the stent, and the anti-circumferential leakage part 160 includes an expandable material. The strip 161 and the first portion of the outer covering membrane 142 wrap the strip 161 of expandable material.

In one embodiment, as shown in FIGS. 1f , 1g , 1h , and 1i , the suture ring 150 includes a suture material strip 151 and a second portion of the outer covering film 142 , and the second portion wraps the suture material strip 151 .

The outer film 142 may have other parts besides the first part and the second part. The outer covering film 142 is a whole, wherein the first part wraps the expandable material strip 161 , and the second part wraps the suture material strip 151 , which reduces splicing of the outer covering film 142 , facilitates processing on the one hand, and reduces material leakage on the other hand.

The suture material belt 151 can be made of silicone rubber, which has moderate elasticity, reduces the rigid extrusion of the valve annulus, and facilitates the suture process. The artificial valve is sewn on the valve annulus through 3 suture points, reducing valve displacement risk, the sewing ring 150 can fit well with the original valve ring, and to a certain extent, reduce paravalvular leakage.

In one of the embodiments, as shown in Fig. 1f, Fig. 1g, Fig. 1h, and Fig. 1i, the covering film 140 includes an inner covering film 141, and is covered on the radially inner side of the stent, and the outflow side of the inner covering film 141 is connected to The fixed edge 132 of the leaflet 130, the inner covering membrane 141 and the outer covering membrane 142 meet and connect to the inflow side of the stent.

The inner covering film 141 and the outer covering film 142 wrap the stent as a whole, reducing exposed parts.

Both the inner covering film 141 and the outer covering film 142 are integral diaphragms, or separate diaphragms.

The inner covering film and the outer covering film are made of different materials or the same material.

In one embodiment, the inner film 141 is made of PU, and the outer film is made of PET (PET fabric).

The seam between the split diaphragms is located on the inflow side of the stent, or on the radially outer side of the stent, or on the radially inner side of the stent.

In one of the embodiments, as shown in FIG. 1f, FIG. 1g, FIG. 1h, and FIG. 1i, the expandable material strip 161 and the suture material strip 151 are completely wrapped by the outer covering film 142 independently, or are clamped and wrapped inside. between the covering film 141 and the outer covering film 142 .

Referring to Fig. 1i, the suture material band 151 extends along the circumferential direction of the stent and has a wave structure, and the inner covering film 141 and the outer covering film 142 do not change the wave configuration of the suture material band 151 when wrapping the suture material band 151, therefore, the obtained The sewing ring 150 also has a corrugated structure consistent with the suture material belt 151, the position opposite to the inflow side is a trough, and the position opposite to the outflow side is a crest, and the trough is adjacent to the anti-circumferential leakage portion 160.

The expandable material belt 161 can be made of PU foam material, which has the characteristics of good elasticity and water impermeability, which is conducive to closely fitting with the valve annulus and reducing paravalvular leakage.

In one embodiment, as shown in Fig. 1f, Fig. 1g, Fig. 1h, and Fig. 1i, the expandable material band 161 includes a base arranged around the periphery of the stent and a water-absorbing swellable material fixed on the base.

The substrate and water-swellable material are made of polymeric materials, for example, one or more of the following materials: polyester, polyethylene terephthalate (PET), polyetheretherketone (PEEK), polypropylene ( PP), polytetrafluoroethylene (PTFE), polyurethane (PU), ultra-high molecular weight polyethylene (UHMWPE), silicone, polyoxymethylene, polyphenylsulfone, polysulfone, polyvinylidene fluoride, polyamide. The substrate can use polymer materials such as PET, and the water-swellable material can use water-swellable materials such as hydrogel or porous foam materials. In one of the embodiments, as shown in Fig. 1f, Fig. 1g, Fig. 1h, Fig. 1i, and Fig. 1j, the water-absorbing swelling material is in the shape of a strip and is continuously distributed in the circumferential direction of the stent, or is in the shape of a plurality of blocks arranged at intervals; The annular portion 120 has a grid structure, and the block-shaped water-absorbing swelling material is respectively located in the hollowed-out areas of the grid structure.

The water-absorbing swellable material is a plurality of blocks arranged at intervals, and the block-shaped water-absorbed swellable material protrudes toward the radially outer side of the stent relative to the stent.

In one embodiment, as shown in FIG. 1 j , the anti-circumferential leakage portion 160 includes a strip of expandable material and a part of the inner membrane 141 , and the strip of expandable material 161 is attached to the inner membrane 141 .

In one embodiment, the inner covering film 141 is made of expandable material, and the expandable material band 161 and the inner covering film 141 are integrally structured.

In one of the embodiments, as shown in FIG. 1j, the expandable material band 161 is connected to the inflow side of the inner membrane 141, and is in the shape of a plurality of blocks arranged at intervals along the circumferential direction of the stent, and the annular part has a grid structure. The blocks of water-absorbing and swelling materials respectively correspond to the hollowed-out areas of the grid structure.

In one of the embodiments, as shown in Fig. 1f, Fig. 1g, Fig. 1h, and Fig. 1i, the sewing ring 150 has a threading mark 170, and the threading mark 170 and the binding post 112 are arranged in a misalignment in the circumferential direction of the stent. That is, in the circumferential direction of the stent, a threading mark 170 is provided at the middle of two adjacent coupling columns 112 .

In one of the embodiments, as shown in Fig. 2h and Fig. 2i, the dotted line in the figure is the direction of blood flow. In the loaded state, the sewing ring 150 has a wave structure extending along the circumference of the stent:

The part on the inflow side is the trough;

The part on the outflow side is the peak.

The bracket has a wave structure both in the loaded state and the released state, the difference lies in the difference in height between the crests and troughs.

In one embodiment, as shown in FIG. 2h and FIG. 2i , the sewing ring 150 is provided with a threading mark 170 , and the threading mark 170 is at a trough position.

The application also provides a method for processing an artificial valve, including:

S100. Connect each valve leaflet to the outflow side edge of the radially inner coating of the stent to form a first preform;

S200. Forming a second preform by using a coating film on the radially outer side of the stent;

S300. Connect the first preform and the second preform to a bracket respectively to form the artificial valve.

In one embodiment, in S100, the anti-peripheral leakage part is formed by adhering the anti-circumferential leakage material to the radially inner membrane of the stent, or forming the anti-circumferential leakage part by using the folds of the radially inner membrane of the stent.

In one embodiment, S200, wrapping the suture material with the first part of the radially outer membrane of the stent to form a second preform.

In one of the embodiments, S200, using the second part of the radially outer covering film of the stent to wrap the anti-circumferential leakage material to form a second preform.

In one embodiment, at S200 , the seam portion and/or the peripheral leakage prevention portion are formed by using the folds of the covering film on the radially outer side of the stent to form a second preform.

In one of the embodiments, the processing method of the artificial valve, step S300 includes:

S310, stitching and connecting the first preform to the bracket, and reserving a first non-sewing area near the top of the bonding column 112;

S320, stitching and connecting the second preform to the bracket, and reserving a second non-sewing area near the top of the bonding column 112;

S330. Sewing the first non-sewing area and the second non-sewing area together with the support to fix each other.

In order to deliver the artificial valve into the body, the present application also provides a delivery system, as shown in Figure 2a, Figure 2b, Figure 2c, and Figure 2f, the delivery system includes:

a control handle 210 having opposing distal and proximal ends;

The valve buckle 230 has a matching structure 231 corresponding to the artificial valve on its periphery;

The sleeve 220 is movably arranged on the outer periphery of the valve buckle 230, and the sleeve 220 can be switched between wrapping and exposing the fitting structure 231;

Two transmission parts 240 are nested inside and outside, and the farthest ends are respectively connected to the valve buckle 230 and the sleeve 220. The proximal ends of the two transmission parts 240 are connected to the control handle 210, and at least one of them is movably matched with the control handle 210 to Adapt to the state switching of the sleeve 220 .

The proximal end of the control handle 210 is the end close to the operator, and the distal end is the end far away from the operator.

The delivery system shrinks the artificial valve to a small size and delivers it to the target position, as shown in Fig. 2g and Fig. 2h. Before the operation, the artificial valve is connected with the valve buckle 230 through the fitting structure 231. Operate the control handle 210 to switch the sleeve 220 from the exposed fitting structure 231 to the wrapping fitting structure 231 , and the artificial valve is compressed in the radial direction to reduce its size, so as to adapt to the placement of the small incision.

In the delivery system, only the sleeve 220 and the valve buckle 230 are close to the artificial valve, and the occlusion is limited. The control handle 210 is far away from the artificial valve, so it is not easy to block the operator's sight, and it is convenient to observe the state of the valve during the delivery of the valve.

The prosthetic valve compressed in the sleeve is smaller in size, easier to pass through the sinotubular junction, and will affect the operator's field of view during delivery.

The working process of the conveying system is shown in Figure 2g ~ Figure 2m, as follows:

Referring to Fig. 2g, the sleeve 220 exposes the fitting structure 231 of the valve buckle 230, and the artificial valve is combined with the fitting structure 231 of the valve buckle 230;

As shown in FIG. 2h, the sleeve 220 is operated to wrap the fitting structure 231 through the control handle 210, and the artificial valve is in a compressed state;

Referring to Fig. 2i, the position of the sleeve 220 is locked through the control handle 210;

Referring to Fig. 2j, the operator passes the suture through the original valve annulus, and passes the suture through the suture ring 150 of the artificial valve in the compressed state, and moves the compressed artificial valve along the suture to deliver to the original valve annulus;

Referring to Fig. 2k, by controlling the handle 210 to unlock the position of the sleeve 220, and operating the sleeve 220 to switch from the state of wrapping the fitting structure 231 to the state of exposing the fitting structure 231, the artificial valve is released and gradually changes from the loading state switch to release state;

As shown in Figure 2l, the artificial valve is completely detached from the valve buckle 230 and returns to its original size;

Referring to Fig. 2m, after the artificial valve is fully released, it is placed on the native valve annulus, the original valve annulus and the sewing ring 150 of the artificial valve are sutured, and the delivery system is withdrawn.

In order to avoid affecting the operator's field of vision, the sleeve 220 can be made of transparent material.

The two transmission parts can slide relative to each other in the axial direction, so as to realize the switch between the two states of the sleeve 220 wrapping and exposing the matching structure 231 . One of the transmission parts is fixed relative to the control handle 210 , and the other transmission part can move in the axial direction. The transmission part that can move in the axial direction can be linked with the sleeve 220 or with the valve buckle 230 .

In one embodiment, as shown in FIG. 2a , FIG. 2b , and FIG. 2c , the distal end of the sleeve 220 is a flaring structure, and the opening edge of the flaring structure is provided with a plurality of escape grooves 221 arranged at intervals in the circumferential direction.

Referring to Fig. 2h, when the artificial valve is compressed, the avoidance groove 221 can accommodate the folds of the sewing ring 150, reducing the radial dimension of the compressed artificial valve.

In one of the embodiments, as shown in Fig. 2a and Fig. 2f, the sleeve 220 structure is omitted in Fig. 2f, and the internal valve buckle 230 structure is shown. The valve buckle 230 is columnar, and the fitting structure 231 is arranged on the valve The circumferential distribution positions of the anti-off grooves and/or anti-off posts on the outer periphery of the buckle 230 and the avoidance grooves 221 correspond to the matching structures 231 .

The fitting structure 231 is in order to keep the artificial valve stably on the valve buckle 230. The valve buckle 230 and the fitting structure 231 of the artificial valve are complementary structures. An anti-off groove corresponding to the shape of the anti-off ear is provided on the artificial valve; if an anti-off groove is arranged on the artificial valve, an anti-off post corresponding to the shape of the anti-off groove is arranged on the valve buckle 230 .

The circumferential distribution position of the escape groove 221 corresponds to the fitting structure 231 , which is based on the compressed state of the artificial valve, so that the avoidance groove 221 can better accommodate the folds of the artificial valve.

Control handle 210 includes:

Housing 211, the housing 211 is an installation room, and one of the two transmission parts is fixed to the installation room;

The moving seat 212 is slidably arranged in the installation room, and the other of the two transmission parts is fixed to the moving seat 212;

The gear adjustment mechanism 213 is arranged between the moving base 212 and the installation chamber, and limits the moving base 212 to at least two gear positions;

The control button 214 is connected with the moving base 212 and at least a part extends to the outside of the casing 211 .

In one of the embodiments, as shown in Fig. 2d and Fig. 2e, the control handle 210 includes:

Housing 211, the housing 211 is an installation room, and one of the transmission parts is fixed in the installation room;

The moving seat 212 is slidably arranged in the installation room, and the other transmission part is fixed to the moving seat 212;

The control button 214 is connected with the movable seat 212, and the movable seat 212 can be operated to move by toggling the control button 214, and the movable seat 212 will be restricted to move when it moves to the gear position corresponding to the gear adjustment mechanism 213, unless an external force is applied through the control button 214 to overcome this limitation.

The gear adjustment mechanism 213 has at least two gears, and the at least two gears respectively correspond to the following positions:

a) The fully compressed position of the prosthetic valve;

b) The position where the prosthetic valve is fully released.

In addition, the stalls that can also be set correspond to the positions of different states during the release process of the artificial valve. For example, the corresponding stalls are set for the state where the sewing ring in the artificial valve is fully opened, and the sewing ring of the artificial valve is kept in a fully opened state. In the open state, the suture ring and the original valve ring are sutured. After the suturing is completed, the artificial valve is completely released and withdrawn from the delivery system.

The complete compression of the artificial valve does not refer to the maximum possible compression state of the artificial valve, but refers to the final compression state that the artificial valve needs to achieve in the delivery system.

Limiting the position of the moving seat 212 by the gear adjustment mechanism 213 can prevent the operator from falling off or displacing the valve due to misoperation during the operation, and ensure the safety of the operation process.

The gear adjustment structure includes:

A plurality of card slots 215 arranged at intervals along the axial direction of the housing 211, and the plurality of card slots 215 are arranged on one of the moving seat 212 and the inner wall of the housing 211;

The elastic tab 216 is disposed on the other one of the moving base 212 and the inner wall of the casing 211 , and the elastic tab 216 is combined with the corresponding slot 215 in different positions of the moving base 212 .

Through the cooperation of the elastic tab 216 and the slot 215 , the moving seat 212 is limited to different gear positions. When the locking groove 215 is disposed on the moving seat 212 , the elastic tongue 216 is disposed on the inner wall of the housing 211 , or when the locking groove 215 is disposed on the inner wall of the housing 211 , the locking groove 215 is disposed on the inner wall of the housing 211 .

The number of slots is the number of gears, and each gear corresponds to the position of a moving seat, and the number of slots can be set as required.

In one of the embodiments, as shown in Fig. 2d and Fig. 2e, the gear adjustment structure includes:

Three card slots 215 arranged at intervals along the axial direction of the housing 211, and the three card slots 215 are arranged on the inner wall of the housing 211;

The elastic tab 216 is arranged on the moving seat 212 , and the elastic tab 216 is combined with the corresponding slot 215 when the moving seat 212 is in different positions.

In one of the embodiments, as shown in Fig. 2d and Fig. 2e, two elastic strips 217 are fixed side by side on the moving seat 212, and a section of each elastic strip 217 protrudes away from each other to form two elastic tabs 216, The slots 215 are in two rows, respectively corresponding to one of the elastic tabs 216 . In FIG. 2 e , one row of card slots 215 is partially covered by the housing 211 .

The positions of the two rows of card slots 215 are in one-to-one correspondence, and each pair of elastic tabs 216 is correspondingly inserted into the corresponding card slots 215 .

In one embodiment, as shown in FIG. 2d and FIG. 2e , the inner wall of the casing 211 is provided with a guide structure 218 for guiding the moving seat 212 . The guiding structure 218 is a sliding groove fixed on the inner wall of the casing 211 . The casing 211 is also provided with a sliding slot for guiding the movement of the control button 214 .

In one of the embodiments, as shown in Fig. 2d and Fig. 2e, the two transmission parts are tube parts, respectively the inner tube 241 connected with the valve buckle 230, and the outer tube 242 connected with the sleeve 220, the outer tube 242 The proximal end of the inner tube is fixed to the movable base 212 , and the proximal end of the inner tube extends beyond the movable base 212 and is fixed to the housing 211 .

When the control handle 210 is operated, the inner tube 241 remains stationary relative to the control handle 210, and by changing the position of the outer tube 242, the sleeve 220 is switched between the two states of wrapping and exposing the fitting structure 231 of the valve buckle 230 .

In one embodiment, as shown in FIG. 2d and FIG. 2e , a locking member 219 is movably embedded in the housing 211 , and the locking member 219 can switch between two states of interfering with and avoiding the moving seat 212 .

When the artificial valve is in a fully compressed state, the locking member 219 interferes with the movement of the moving seat 212, that is, the artificial valve is stably installed in the delivery system, and misoperation is prevented during the movement process. When the artificial valve needs to be released from the delivery system, the The locking member 219 is switched to a state of avoiding the movement of the moving seat 212 .

In one of the embodiments, as shown in FIG. 2d, an L-shaped limiting groove 250 is provided on the distal side of the moving seat 212, and the limiting groove 250 includes a longitudinal section extending axially along the housing 211 and a longitudinal section connected to the longitudinal section. Vertically connected transverse sections, where the longitudinal ends are open at the ends;

The locking member 219 is in the transverse section and the longitudinal section respectively under the two states of interfering with and avoiding the moving seat 212 .

During the conversion of the artificial valve from the non-compressed state to the fully compressed state, the locking member 219 enters the longitudinal section through the open opening. 219 is toggled along the transverse section to make the locking piece 219 away from the longitudinal section. Since the locking piece 219 interferes with the transverse section in the moving direction of the moving seat 212, the movement of the moving seat 212 is restricted.

When the artificial valve needs to be released, the locking member 219 is moved along the transverse section, so that the locking member 219 is located in the longitudinal section, and the locking member 219 can move along the longitudinal section in the moving direction of the moving seat 212 to release the movement restriction of the moving seat 212.

Referring to Fig. 2b, the length of the delivery system (that is, the sum of the dimensions of D1 and D2) is 300-400 mm. The artificial valve delivered by the delivery system in this application is neither an interventional valve nor a surgical valve, and the length of the delivery system is also between the two delivery systems. The length D1 of the control handle in the delivery system is 100-150mm, except for the control handle. The length D2 of the component is 150-300 mm, the dimension D3 of the sleeve end is 15-20 mm, and the width D4 of the control handle is 15-30 mm.

The method for using the delivery system comprises the steps of:

The control handle driving sleeve is in the state of wrapping the adapter structure,

The outflow side of the artificial valve is gathered radially inward, and the inflow side is flaring;

When the control handle driving sleeve is in the state of wrapping the matching structure, as shown in Figure 2h, only the supporting part of the artificial valve is located inside the sleeve, the annular part is not completely accommodated by the sleeve, and the inflow side of the annular part is still located in the sleeve. outside of the barrel.

The technical features of the above-mentioned embodiments can be combined arbitrarily. To make the description concise, all possible combinations of the technical features in the above-mentioned embodiments are not described. However, as long as there is no contradiction in the combination of these technical features, should be considered as within the scope of this specification.

The above-mentioned embodiments only represent several implementation modes of the present application, and the description thereof is relatively specific and detailed, but it should not be construed as limiting the scope of the patent for the invention. It should be noted that those skilled in the art can make several modifications and improvements without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the scope of protection of the patent application should be based on the appended claims.

Claims

An artificial valve system, characterized in that the artificial valve system includes an artificial valve and a delivery system that cooperate with each other, and the artificial valve includes: a stent, a valve leaflet arranged on the stent, and a membrane attached to the stent , the inside of the stent encloses a blood flow channel, the stent has opposite inflow sides and outflow sides, and the stent includes:

The support part is surrounded by a plurality of U-shaped frames and the opening of each U-shaped frame faces the outflow side, the sides of two adjacent U-shaped frames are adjacent to each other to form a joint column, and the sides of two adjacent U-shaped frames meet at the joint column top of

an annular part, which is a radially deformable grid structure, and is located on the inflow side of the support part as a whole;

The delivery system includes:

a control handle having opposing distal and proximal ends;

The valve buckles, and its periphery has a matching structure corresponding to the supporting part of the artificial valve;

The sleeve is movably arranged on the outer periphery of the valve buckle, and the sleeve can be switched between wrapping and exposing the fitting structure;

When the sleeve is in the state of wrapping the matching structure, the artificial valve is in a loading state where the outflow side is gathered radially inward, and the inflow side is flaring;

When the sleeve is in the state of exposing the fitting structure, the artificial valve is in the radially outward expansion of the outflow side, and the artificial valve is in a release state of a straight cylindrical structure as a whole;

Two transmission parts, nested inside and outside, and the farthest ends are respectively connected to the valve buckle and the sleeve, the proximal ends of the two transmission parts are connected to the control handle, and at least one of them is connected to the control handle. The active cooperation between them is adapted to the state switching of the sleeve.
The artificial valve system according to claim 1, characterized in that a sewing ring is arranged on the outer periphery of the stent.
The artificial valve system according to claim 2, wherein an annular anti-peripheral leakage part is surrounded on the periphery of the stent, and the anti-peripheral leakage part is on the inflow side of the sewing ring.
The artificial valve system according to claim 3, wherein the sewing ring extends circumferentially along the stent and has a wave structure, the position opposite to the inflow side is a wave trough, and the position opposite to the outflow side is a wave peak, so Said trough and the anti-peripheral leakage part are attached to each other.
The artificial valve system according to claim 2, wherein the sewing ring is on the inflow side of the U-shaped frame, and there is a space between the U-shaped frame and the U-shaped frame.
The artificial valve system according to claim 3, characterized in that, the covering film includes an outer covering film covering the radially outer side of the stent, and the anti-circumferential leakage part includes an expandable material strip and the outer covering film A first portion of a membrane, and the first portion wraps around the strip of expandable material.
The artificial valve system according to claim 6, wherein the outer covering membrane is made of PET material.
7. The prosthetic valve system of claim 7, wherein the sewing ring includes a strip of suture material and a second portion of the outer covering, the second portion wrapping around the strip of suture material.
The artificial valve system according to claim 7, wherein each leaflet has a fixed edge connected to the U-shaped frame and a free edge that cooperates with other leaflets to change the opening degree of the blood flow channel, and the covering film includes a covering The inner covering membrane covering the radial inner side of the stent, the outflow side of the inner covering membrane is connected to the fixed edge of the leaflet, the inner covering membrane and the outer covering membrane are converging and connected to the stent the inflow side.
The artificial valve system according to claim 9, characterized in that, the inner covering membrane and the outer covering membrane are an integral diaphragm, or are separate diaphragms.
The artificial valve system according to claim 8, characterized in that, the expandable material band and the suture material band are independently completely wrapped by the outer covering membrane, or clamped and wrapped around the inner covering membrane and between the outer covering film.
The artificial valve system according to claim 6, characterized in that, the expandable material belt is in the shape of a water-absorbing expandable material and is continuously distributed in the circumferential direction of the stent, or is a plurality of blocks arranged at intervals; The inner part has a grid structure, and the blocky water-absorbing swelling materials are respectively located in the hollowed-out areas of the grid structure.
The artificial valve system according to claim 6, wherein the expandable material band comprises a base arranged around the periphery of the stent and a water-absorbing swellable material fixed on the base.
The artificial valve system according to claim 2, wherein the sewing ring is provided with a threading mark, and the threading mark is misaligned with the coupling column in the circumferential direction of the stent.
The artificial valve system according to claim 4, characterized in that there is a threading mark on the sewing ring, and the threading mark is at a trough position.
The artificial valve system according to claim 1, wherein the valve buckle is columnar, and the fitting structure is an anti-off groove and/or an anti-off post arranged on the outer periphery of the valve buckle.
The artificial valve system according to claim 1, wherein the control handle comprises:

A housing, the housing is an installation chamber, and one of the two transmission parts is fixed in the installation chamber;

a moving seat, which is slidably arranged in the installation chamber, and the other of the two transmission parts is fixed to the moving seat;

a gear adjustment mechanism, configured between the moving base and the installation chamber, and restricting the moving base to at least two gears;

The control button is connected with the moving base, and at least a part extends to the outside of the housing.
The artificial valve system according to claim 1, wherein the distal end of the sleeve is a flaring structure, and the opening edge of the flaring structure is provided with a plurality of escape grooves arranged at intervals in the circumferential direction, the The circumferential distribution positions of the escape grooves correspond to the matching structures.
The artificial valve system according to claim 17, wherein the gear adjustment structure comprises:

A plurality of card slots arranged at intervals along the axial direction of the housing, the plurality of card slots are arranged on one of the moving seat and the inner wall of the housing;

The elastic tab is arranged on the other one of the moving seat and the inner wall of the housing, and the elastic tab is combined with the corresponding slot when the moving seat is in different positions.
The artificial valve system according to claim 19, wherein two elastic strips are fixed side by side on the moving seat, and a section of each elastic strip protrudes away from each other to form two elastic tabs. There are two rows of card slots, corresponding to one of the elastic tabs respectively.
The artificial valve system according to claim 17, characterized in that a locking piece is movably embedded in the casing, and the locking piece can be switched between two states of interfering with and avoiding the moving seat.
The artificial valve system according to claim 21, characterized in that, the distal side of the moving base is provided with an L-shaped limiting groove, and the limiting groove includes a longitudinal section extending axially along the casing and is connected to the a transverse segment vertically connected to a longitudinal segment, wherein the ends of the longitudinal ends are open;

The locking member is respectively located in the transverse section and the longitudinal section under the two states of interfering with and avoiding the moving seat.
The artificial valve system according to claim 1, wherein the delivery system has a length of 300-400 mm.
The use method of the delivery system according to any one of claims 1-23, characterized in that it comprises the following steps:

The control handle drives the sleeve to move relative to the valve buckle to expose the valve buckle;

The fitting structure of the valve buckle is combined with the supporting part of the artificial valve;

The driving sleeve of the control handle is in the state of wrapping the matching structure, the outflow side of the artificial valve is gathered radially inward, and the inflow side is flaring;

The control handle driving sleeve is in the state of releasing the adapting structure, the outflow side of the artificial valve breaks away from the adapting structure and expands radially outward, and the artificial valve has a straight cylindrical structure as a whole.