CN118338866A

CN118338866A - Prosthetic valve systems and methods of use

Info

Publication number: CN118338866A
Application number: CN202280081974.XA
Authority: CN
Inventors: 章合强; 黄崇敏; 郭月
Original assignee: Jilin Qiming Haoyue Biotechnology Co ltd
Current assignee: Jilin Qiming Haoyue Biotechnology Co ltd
Priority date: 2021-12-31
Filing date: 2022-12-28
Publication date: 2024-07-12
Also published as: WO2023125684A1; CN219896030U; CN116370149A; CN116459040A

Abstract

A prosthetic valve system and method of use, wherein the prosthetic valve system comprises a cooperating prosthetic valve and a delivery system, the prosthetic valve comprising: the support, set up valve leaf (131) on the support, attached tectorial membrane (140) on the support, the inside blood flow passageway that encloses of support, support have relative inflow side and outflow side, the support includes: the support part (110) is surrounded by a plurality of U-shaped frames (111), the opening of each U-shaped frame (111) faces the outflow side, the side edges of two adjacent U-shaped frames (111) are adjacent to each other to form a combination column (112), and the side edges of the two adjacent U-shaped frames (111) are intersected to the top end of the combination column (112); the annular portion (120) is a radially deformable mesh structure and is located on the inflow side of the support portion (110) as a whole.

Description

Prosthetic valve systems and methods of use

Technical Field

The application relates to the technical field of medical appliances, in particular to a prosthetic valve system and a use method thereof.

Background

In the prior art, prosthetic aortic valves are broadly classified into transcatheter interventional valves, which have a small wound, can be implanted without stopping the heart, do not require extracorporeal circulation and general anesthesia, and have rapid patient recovery, and surgical implantable valves, which have limitations including but not limited to: by means of structural anchoring, high demands are placed on the aortic anatomy of the patient; since no suturing is performed, the anti-migration performance of the interventional valve must be evaluated; the native valve of the patient cannot be excised before implantation, and when the native valve is lifted by the implanted interventional valve, the risk of blocking the coronary opening exists; most interventional valves present a paravalvular leakage risk; few products are designed with Valve-in-Valve (ViV) functionality, in which a Valve, i.e., a new Valve, is deployed in the failed Valve.

The surgical implantable valve includes: conventional open-chest surgical valves and suture-free (low-suture) surgical valves, wherein the conventional open-chest surgical valves have the following advantages:

(1) The patient's native valve She Jianchu can be protected from interference with the post-implantation surgical valve prior to implantation;

(2) The indication may cover substantially all forms of valve disease;

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

(4) Because the number of the suture needles is large, the risk of displacement is avoided, and the paravalvular leakage is basically avoided;

Traditional open chest surgical valves also have limitations, such as:

(1) The operation needs to cut the sternum and the aorta, so that the damage to the body of a patient is large, the incision is large (about 20 cm), the pain is large and the recovery is slow;

(2) According to the experience of doctors, under the conditions of extracorporeal circulation and cardiac arrest, the traditional surgical valve needs to be subjected to about 90 needles (14 positions each of which is subjected to 6 needles), the circulation blocking time usually needs about 1 hour, and related researches show that the longer circulation blocking time has the risk of causing irreversible brain injury;

(3) The root of the aorta of the patient is damaged due to the fact that the stitching times are more;

(4) Surgical open chest surgery has higher demands on the age, physical condition, etc. of the patient than interventional valves.

The minimally invasive small incision surgical valve without suture (few suture) has fewer products, and can solve partial problems caused by more suture in the traditional chest opening surgical valve operation.

During the surgical procedure for minimally invasive small incision heart valve implantation, a delivery system is typically employed to assist in delivering and implanting the prosthetic heart valve into the patient, and typically enables the surgeon to precisely position the prosthetic heart valve within the heart channel or another region of the heart, and the delivery system is also used to securely hold the prosthetic heart valve in place until suturing is complete and the sutures are tied.

In the case of some small incision prosthetic valve implants, the delivery system is coupled with an elongated handle, the surgeon manipulates the valve to its desired implantation location by manipulating the handle, and then removes the elongated hand handle, suturing the sewing ring to the native valve ring, during which the delivery system remains coupled to the prosthetic valve to protect the valve, which may obstruct the surgeon's view during the suturing operation.

Disclosure of Invention

Aiming at the implantation problem of the artificial valve, the artificial valve and a system for implanting the artificial valve are provided, and the delivery system is used for accurately placing the artificial valve at a target position after partial compression and is applied to minimally invasive small incision operation.

A prosthetic valve system comprising a cooperating prosthetic valve and a delivery system, the prosthetic valve comprising: the support, set up the lamella on the support, attach in tectorial membrane on the support and be fixed in the sewing ring of support periphery, the inside blood flow passageway that encloses of support, the support has relative inflow side and outflow side, the support includes:

The support part is surrounded by a plurality of U-shaped frames, the opening of each U-shaped frame faces the outflow side, the side edges of two adjacent U-shaped frames are adjacent to each other to form a combination column, and the side edges of the two adjacent U-shaped frames are intersected to the top end of the combination column;

An annular part which is a grid structure deformable in the radial direction and is positioned on the inflow side of the supporting part as a whole;

The conveying system includes:

a control handle having opposite distal and proximal ends;

The periphery of the valve buckle is provided with an adapting structure corresponding to the supporting part of the artificial valve;

the sleeve is movably arranged at the periphery of the valve buckle, and the sleeve can be switched between two states of wrapping and exposing the adapting structure;

when the sleeve is in a state of wrapping the adapting structure, the artificial valve is in a loading state that the outflow side is gathered inwards in the radial direction and the inflow side is flared;

When the sleeve is in a state of exposing the adapting structure, the artificial valve is in a release state of a straight cylinder structure, wherein the outflow side of the artificial valve is expanded outwards in a radial direction;

The valve buckle and the sleeve are respectively connected to the farthest ends of the two transmission parts, the proximal ends of the two transmission parts are connected to the control handle, and at least one transmission part is in movable fit with the control handle so as to adapt to the state switching of the sleeve.

The following provides several alternatives, but not as additional limitations to the above-described overall scheme, and only further additions or preferences, each of which may be individually combined for the above-described overall scheme, or may be combined among multiple alternatives, without technical or logical contradictions.

Optionally, a suture ring is arranged on the periphery of the bracket.

Optionally, the outer periphery of the support is surrounded by an annular peripheral leakage preventing part, and the peripheral leakage preventing part is positioned on the inflow side of the sewing ring.

Optionally, the sewing ring extends along the circumference of the support and has a wave structure, the part opposite to the inflow side is a wave trough, the part opposite to the outflow side is a wave crest, and the wave trough is abutted to the circumference leakage prevention part.

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

Optionally, the covering film comprises an outer covering film covering the radial outer side of the stent, the peripheral leakage prevention part comprises an expandable material strip and a first part of the outer covering film, and the first part wraps the expandable material strip.

Optionally, the outer cover is made of PET material.

Optionally, the inner covering film adopts an expandable material, and the expandable material belt and the inner covering film are of an integral structure.

Optionally, the sewing ring comprises a band of sewing material and a second portion of the outer cover, and the second portion encapsulates the band of sewing material.

Optionally, each leaflet has a fixed edge connected to the U-shaped frame and a free edge that cooperates with other petals She Xiangpei to change the opening of the blood flow channel, the covering film includes an inner covering film that covers the radially inner side of the stent, the outflow side of the inner covering film is abutted to the fixed edge of the leaflet, and both the inner covering film and the outer covering film are connected to the inflow side of the stent in a converging manner.

Optionally, the inner covering film and the outer covering film are integrated films or split films.

Optionally, the expandable material strip and the suture material strip are each independently entirely wrapped by the outer cover film or are sandwiched between the inner cover film and the outer cover film.

Optionally, the expandable material band is a water-absorbing expansion material band and is continuously distributed along the circumferential direction of the bracket, or is a plurality of blocks arranged at intervals; the annular part is provided with a grid structure, and the massive water-absorbing expansion material is divided into hollow areas corresponding to the grid structure.

Optionally, the strip of swellable material comprises a substrate disposed about the periphery of the stent and a water-swellable material affixed to the substrate.

Optionally, the suture ring is provided with a threading mark, and the threading mark and the binding post are arranged in a dislocation manner in the circumferential direction of the bracket.

Optionally, the suture ring is provided with a threading mark, and the threading mark is positioned at the trough position.

Optionally, the valve buckle is columnar, and the adaptation structure is an anti-drop groove and/or an anti-drop column arranged at the periphery of the valve buckle.

Optionally, the control handle includes:

A housing, in which a mounting chamber is formed, one of the two transmission members being fixed to the mounting chamber;

A moving seat slidably disposed in the installation chamber, the other of the two transmission members being fixed to the moving seat;

a shift position adjusting mechanism arranged between the movable seat and the installation chamber and limiting the movable seat to at least two shift positions;

and a control button connected with the movable seat and at least one part of which extends to the outside of the shell.

Optionally, the distal end of the sleeve is a flaring structure, a plurality of avoidance grooves are arranged at intervals along the circumferential direction at the opening edge of the flaring structure, and the circumferential distribution positions of the avoidance grooves correspond to the adaptation structure.

Optionally, the gear adjusting structure includes:

The clamping grooves are arranged at intervals along the axial direction of the shell and are arranged on one of the movable seat and the inner wall of the shell;

The elastic clamping tongue is arranged on the other one of the movable seat and the inner wall of the shell, and is combined with the corresponding clamping groove when the movable seat is in different gears.

Optionally, the movable seat is fixed with two elastic strips side by side, one section of each elastic strip is outwards protruded to form two elastic clamping tongues, and the two clamping grooves are respectively corresponding to one elastic clamping tongue.

Optionally, a locking member is movably embedded in the housing, and the locking member can be switched between two states of interfering and avoiding the movable seat.

Optionally, the distal end side of the movable seat is provided with an L-shaped limit groove, and the limit groove comprises a longitudinal section extending along the axial direction of the shell and a transverse section vertically communicated with the longitudinal section, wherein the end part of the longitudinal end is an open mouth;

the locking piece is respectively arranged at the transverse section and the longitudinal section in two states of interference and avoidance of the movable seat.

Optionally, the length of the conveying system is 300-400 mm.

The application also provides a using method of the conveying system, which comprises the following steps:

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

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

The control handle drives the sleeve to be in a state of wrapping the adapting structure, the outflow side of the artificial valve is gathered radially inwards, and the inflow side is flared;

The control handle drives the sleeve to be in a state of releasing the adapting structure, the outflow side of the artificial valve is separated from the adapting structure and expands outwards in a radial direction, and the artificial valve is in a straight cylinder structure as a whole.

The artificial valve provided by the application is implanted into a body in a surgical operation mode, and the delivery system is used for accurately delivering the artificial valve to a target position after partial compression and is applied to minimally invasive small incision operation.

Drawings

FIG. 1a is a schematic view of a holder for an artificial valve;

FIG. 1b is a front view of a holder for an artificial valve;

FIG. 1c is a schematic view of a stent attached leaflet of an artificial valve;

FIG. 1d is a schematic illustration of a stent attached leaflet of an artificial valve;

FIG. 1e is a schematic view of a holder for an artificial valve;

FIG. 1f is a schematic view of an artificial valve;

FIG. 1g is a schematic view of an artificial valve;

FIG. 1h is a schematic illustration of an artificial valve;

FIG. 1i is an exploded view of an artificial valve;

FIG. 1j is a schematic view of a leak-proof portion of an artificial valve;

FIG. 1k is a schematic view of an integrated peripheral leakage prevention portion and inner cover film structure of an artificial valve;

FIG. 2a is a schematic diagram of a conveyor system;

FIG. 2b is a schematic diagram of a conveyor system;

FIG. 2c is a cross-sectional view taken along line A-A in FIG. 2 b;

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

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

FIG. 2f is a schematic illustration of a valve clip in a delivery system (with the sleeve structure omitted);

FIG. 2g is a schematic view of the delivery system beginning loading of a prosthetic valve;

FIG. 2h is a schematic illustration of the delivery system fully loaded with a prosthetic valve;

FIG. 2i is a schematic view of the delivery system fully loaded with the prosthetic valve and the locking element locked;

FIG. 2j is a schematic illustration of a delivery system for placement of a prosthetic valve into a native annulus;

FIG. 2k is a schematic illustration of the delivery system placing a prosthetic valve into the native annulus with the sewing ring fully deployed;

FIG. 2l is a schematic illustration of the delivery system fully releasing the prosthetic valve;

Fig. 2m is a schematic view of the artificial valve after implantation in a human body.

In the figure: 110. a support part; 111. a U-shaped frame; 112. a binding column; 113. a connection end; 114. a connecting lug; 115. a contact bar; 116. a hollowed-out window; 120. an annular portion; 121. v-shaped frame strips; 122. a deformation release region; 130. valve leaves; 131. free edges; 132. a fixed edge; 140. coating a film; 141. an inner coating film; 142. an outer coating film; 150. a sewing ring; 151. stitching the strip of material; 160. a leakage prevention part; 161. a band of expandable material; 170. threading a mark;

210. A control handle; 211. a housing; 212. a movable seat; 213. a gear adjusting mechanism; 214. a control knob; 215. a clamping groove; 216. an elastic clamping tongue; 217. an elastic strip; 218. a guide structure; 219. a locking member; 220. a sleeve; 221. an avoidance groove; 230. valve claspers; 231. an adaptation structure; 240. a transmission member; 241. an inner tube; 242. an outer tube; 250. and a limit groove.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

For a better description and illustration of embodiments of the application, reference should be made to one or more of the accompanying drawings, but the additional details or examples used to describe the drawings should not be construed as limiting the scope of any of the inventive, presently described embodiments or preferred modes of carrying out the application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

Referring to fig. 1a, 1b, a prosthetic valve stent having opposite inflow and outflow sides, comprising:

A supporting portion 110 surrounded by a plurality of U-shaped frames 111 with the opening of each U-shaped frame 111 facing the outflow side (the dotted line in fig. 1a is the blood flow direction), the sides of two adjacent U-shaped frames 111 being adjacent to each other to form a joint column 112, the sides of two adjacent U-shaped frames 111 meeting to the top end of the joint column 112;

The annular portion 120 is a grid structure deformable in the radial direction and is located on the inflow side of the support portion 110 as a whole, and the connection portions between the annular portion 120 and the support portion 110 are plural and correspond to turning portions on the inflow side in each U-shaped frame 111, respectively.

The annular portion 120 is a radially deformable mesh structure, which is a mesh structure as a whole, and does not strictly require a complete mesh at each portion in the circumferential direction.

Because the annular portion 120 has a space that is deformable in the radial direction, the prosthetic valve stent can be compressed to a certain extent in the radial direction, and in the process of prosthetic valve implantation by a surgical operation, the prosthetic valve stent is in a compressed state, so that compared with the conventional surgical operation, the size of the incision can be reduced, and the damage to the body of a patient can be reduced.

The artificial valve bracket is fixed with the valve annulus in a surgical suture mode, inherits the advantages of a surgical artificial valve, such as extremely low shift risk, low coronary artery blocking risk, capability of cutting diseased native valve leaves, wide indication and capability of realizing the function of the valve in the valve (namely, after the later-stage valve fails, a new valve can be placed in the valve).

In one embodiment, referring to fig. 1a, 1b, 2h, the stent has opposite loading and release states, wherein:

In the loading state, the outflow side of the bracket gathers radially inwards, and the inflow side of the bracket is flared;

in the released state, the stent outflow side expands radially outwardly, the stent being of generally straight cylindrical configuration.

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

The stent has opposite loading and release conditions, and correspondingly, the prosthetic valve also has corresponding loading and release conditions, wherein:

in the loading state, the outflow side of the artificial valve gathers radially inwards, and the inflow side of the artificial valve is flared;

In the released state, the outflow side of the prosthetic valve expands radially outwardly, the prosthetic valve being generally straight.

In fig. 1a and 1b, the stent of the prosthetic valve is in a released state, the stent is in an overall upper straight tube structure, in fig. 2h, the stent of the prosthetic valve is in a loading state, the sides of the U-shaped frame 111 of the supporting portion 110 are mutually close to form an inwardly gathered structure, and the annular portion 120 is adaptively flared towards the outflow side.

The bracket is of an integrated structure and adopts a self-expandable memory material. For example, a nickel-titanium alloy pipe is used for cutting, and then the bracket is obtained after heat treatment and shaping.

The support of the artificial valve is made of nickel-titanium alloy material, can be compressed to 16mm in the radial direction, reduces the difficulty of descending the valve to the valve annulus, can meet the requirement of support placement by controlling the incision length of the body surface of a patient to be 4-6 cm, is far smaller than the incision length of 20cm required by the implantation of the traditional surgical valve, reduces the suturing times, saves the blocking time and reduces the damage to the root of the aorta of the patient.

In addition, the intercostal access way can be selected by the small incision, so that pain of patients caused by median incision of sternum is avoided, and in addition, for patients with smaller sinus canal joint diameter, the implantation difficulty is reduced.

The support has expandable structure, adopts nickel titanium material simultaneously, and the radial holding power of usable support anchors, does not need the sacculus to expand, reduces the complexity of operation.

In one embodiment, as shown in fig. 1a and 1b, three U-shaped frames 111 are provided, turning portions of each U-shaped frame 111 at the inflow side are connection ends 113, and the annular portion 120 is fixed to each connection end 113 through the vertex of the grid structure at the corresponding position.

The turning part of the inflow side, i.e., the middle position of the bottom of the U-shaped frame 111 is defined as a connection end 113, and the connection end 113 is fixedly connected with the mesh structure vertex of the ring portion 120.

In one embodiment, referring to fig. 1a and 1b, the frame bar strength of the U-shaped frame 111 is greater than the frame bar strength of the annular portion 120.

The outflow end of the valve is a leaflet working area, namely, the U-shaped frame 111 is used as the most direct support when the leaflet 130 moves, the frame strip strength of the U-shaped frame 111 is greater than that of the annular part 120, when the leaflet 130 is opened and closed, the U-shaped frame 111 has higher strength, deformation is not easy to occur, swing is reduced, the influence on the annular part 120 is reduced, and the durability of the support is enhanced.

The grid structure of the annular portion 120 mainly plays an anchoring role, and on the premise of guaranteeing radial supporting force, the frame strip strength of the annular portion 120 is smaller than that of the U-shaped frame 111, so that when the annular portion 120 is pressed by external force, deformation of the annular portion is enabled to conform to the external force, and influence on the U-shaped frame 111 of the supporting portion 110 is reduced.

To achieve the difference in frame bar strength, the frame bar of the U-shaped frame 111 may be wider or thicker than the frame bar of the annular portion 120, and in view of convenience in processing, it is preferable that the frame bar of the U-shaped frame 111 be wider than the frame bar of the annular portion 120.

In one embodiment, referring to fig. 1a and 1b, the top end of the coupling post 112 widens in the circumferential direction of the stent to form a connecting lug 114 for adapting to the delivery system.

The attachment tabs 114 are used to attach the stent of the prosthetic valve to the delivery system, allowing the stent to be stably installed in the delivery system. The connecting lugs 114 may take a variety of configurations, and may take other forms, such as semi-circular, or radially extending steps, in addition to the generally rectangular configuration shown in fig. 1a, 1 b.

In one embodiment, as shown in fig. 1a and 1b, one or more contact bars 115 are disposed between the sides of two adjacent U-shaped frames 111, and the contact bars 115 define one or more hollow windows 116 at the location of the connecting column 112.

Tie bar 115 forms a connection structure between the sides of adjacent two U-shaped frames 111, on the one hand, strengthening the connection strength between the sides of adjacent two U-shaped frames 111, and on the other hand, excessively interfering with the deformation of the sides of U-shaped frames 111.

During sewing, the leaflet 130 has a flange that wraps around a portion of the side edge of the U-shaped frame 111, and at least one hollowed window 116 is configured to receive the flange of the leaflet 130.

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

The support portion 110 is used for fixing the leaflet 130, and has at least an axial length corresponding to the leaflet 130, while the annular portion 120 is used for positioning in a blood vessel and bearing a structure for preventing paravalvular leakage, because the prosthetic valve is sutured on the annulus in a surgical operation manner, the annular portion 120 is easy to satisfy the positioning requirement, and does not need an excessively long axial length, and meanwhile, the structure for preventing paravalvular leakage does not need an excessively long axial length, so that on the premise of satisfying the use requirement, the axial length is reduced as much as possible, and adverse effects on tissue of an implantation site are reduced.

In one embodiment, referring to FIG. 1b, L1: l2=1: 1.5 to 1:3.

In one embodiment, referring to fig. 1a and 1b, at least a portion of the annular portion 120 in the circumferential direction is a V-shaped frame strip 121.

The V-shaped frame strip 121 is more easily deformed when being subjected to external force, and the degree of the V-shaped included angle is changed, so that the annular part 120 is more easily expanded outwards in the circumferential direction when being subjected to radial external force due to the existence of the V-shaped frame strip 121 when the valve is required to be implanted in the valve, thereby facilitating the implantation of a new valve.

When the annular portion 120 expands outwards under radial force, the V-shaped frame bars conform to the external force, so that the influence on the supporting portion 110 is reduced, namely, the influence on the form of the valve leaflet 130 connected to the supporting portion 110 is reduced.

The self-expanding valve and the ball expanding valve can be used as the middle valve implant, and the V-shaped frame strip 121 of the bracket can be expanded under the action of external force, so that after the self-expanding valve is implanted, the valve with a small incision can be expanded without rebound, and the opening area is not influenced.

In one embodiment, referring to fig. 1a and 1b, the mesh structure of the annular portion 120 is a circumferentially arranged unit cell, and the unit cell is only one turn in the axial direction.

The annular part 120 is shorter in axial dimension, only one circle of cells are arranged, the density of the cells is reduced, the annular part 120 is easier to deform under the action of radial external force, and due to the fact that a valve is implanted in a surgical operation mode, stitching exists between the valve and an annulus, the annular part 120 is easy to deform, adverse effects on positioning are avoided, and when the implantation of the valve in the valve is needed, the annular part is easier to expand circumferentially, so that the implantation of a new valve is facilitated.

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

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

In one embodiment, as shown in FIG. 1b, the loop 120 is straight in the flattened state, where the line between the outflow-side vertices of each cell is straight.

Only part of the cells of the annular portion 120 are connected with the connecting ends 113 of the U-shaped frame 111, the rest of the cells are not connected with the U-shaped frame 111, and the deformation between the side edge of the U-shaped frame 111 and the annular portion 120 is relatively independent.

In one embodiment, referring to fig. 1a, 1b, at least one cell is a deformation releasing cell open to the inflow side of the annular portion 120.

The V-shaped frame strip 121 is a deformation releasing grid, and under the action of radial external force, the deformation releasing grid is preferentially deformed so as to conform to the external force, and the other circumferentially closed cells are subsequently deformed.

In one embodiment, as shown in FIGS. 1a and 1b, the cells are generally diamond-shaped or hexagonal except for the deformation releasing cells.

The shape of the cells is not strictly geometric, there is local deformation based on the processing requirements, but at least the radial shrinkage and expansion requirements of the stent should be met.

In one embodiment, referring to FIG. 1a, the number of deformation releasing pockets and the circumferential position are in one-to-one correspondence with the bond posts 112.

The deformation releasing grids are in one-to-one correspondence with the positions of the binding columns 112, when the external force is applied, the circumferential expansion positions of the annular portion 120 and the supporting portion 110 are aligned with each other in the axial direction, deformation of the annular portion 120 and the supporting portion 110 is less in traction, namely, when the annular portion 120 is expanded in the circumferential direction, the deformation is not limited by the supporting portion 110, and vice versa.

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

The V-shaped opening is more likely to expand when subjected to radially outward forces toward the inflow side of the annular portion 120.

Referring to fig. 1e, the present application also provides a stent for a prosthetic valve having opposite inflow and outflow sides, comprising:

A supporting portion 110 surrounded by a plurality of U-shaped frames 111, wherein the opening of each U-shaped frame 111 faces the outflow side, the side edges of two adjacent U-shaped frames 111 are adjacent to each other to form a combination column 112, and the side edges of two adjacent U-shaped frames 111 are intersected to the top end of the combination column 112;

The annular portion 120 is a radially deformable mesh structure and is located on the inflow side of the support portion 110 as a whole, and at least a portion of the annular portion 120 in the circumferential direction is a deformation release region 122, and the deformation release region 122 is located in alignment with the inflow side of the binding post 112.

The deformation release region 122 is easier to deform and expand outwards when being stressed radially relative to other parts of the annular part 120, and the annular part 120 is easy to deform without adverse effect on positioning due to the fact that the valve is implanted in a surgical operation mode, and the annular part 120 is easier to expand circumferentially when the implantation of the valve in the valve is needed, so that the implantation of a new valve is facilitated.

The deformation releasing area 122 is aligned with the inflow side of the coupling post 112, and when an external force is applied, the circumferential expansion portions of the annular portion 120 and the supporting portion 110 are aligned with each other in the axial direction, so that the deformation of the annular portion 120 and the supporting portion 110 is less constrained, that is, the annular portion 120 is not constrained by the supporting portion 110 when being expanded in the circumferential direction, and vice versa.

When the annular portion 120 expands radially outward, the deformation release region 122 conforms to the external force, so that the influence on the support portion 110, that is, the influence on the form of the leaflet 130 connected to the support portion 110 is reduced.

In one embodiment, as shown in fig. 1e, the deformation releasing area 122 is a frame strip structure that is extendable in the circumferential direction of the stent, and the area surrounded by the frame strip structure is an open area.

The deformation release region 122 adopts a circumferentially extensible frame strip structure, and when the frame strip structure is subjected to radial external force, the frame strip structure is extended to deform the deformation release region 122, and the arrangement of the open region allows a larger deformation amount.

In one embodiment, referring to fig. 1e, the frame bar structure is V-shaped or W-shaped.

The V-shaped frame strip structure does not need the balloon to expand, and the radial supporting force of the V-shaped frame strip 121 structure is utilized to closely attach to the primary aortic valve ring of a patient, so that the stability of the valve is enhanced, the perivalvular leakage is reduced, and the complexity of operation is reduced.

In one embodiment, referring to fig. 1e, the number and circumferential positions of the deformation releasing regions 122 are in one-to-one correspondence with the binding posts 112.

The deformation releasing areas 122 are in one-to-one correspondence with the positions of the binding posts 112, when an external force is applied, the circumferential expansion positions of the annular portion 120 and the supporting portion 110 are aligned with each other in the axial direction, deformation of the annular portion 120 and the supporting portion 110 is less inhibited, that is, the annular portion 120 cannot be inhibited by the supporting portion 110 when being expanded in the circumferential direction, and vice versa.

The present application also provides a prosthetic valve, as shown in fig. 1f, 1g, 1h, 1i, comprising:

The blood flow channel is enclosed inside the bracket;

A plurality of leaflets 130, each leaflet 130 having a fixed edge 132 connected to the U-shaped frame 111 and a free edge 131 that cooperates with the other leaflets 130 to vary the degree of openness of the blood flow path;

a coating 140 covering the inner side and/or the outer side of the stent in the radial direction;

A sewing ring 150 secured to the outer periphery of the stent.

The coating 140 is coated on the inner side, the outer side, or both the inner side and the outer side in the radial direction of the stent.

After implantation in the human body, the sewing ring 150 is used to suture with the valve annulus to fix the valve position.

In one embodiment, referring to FIG. 1f, the outer circumference of the stent is surrounded by an annular circumferential leakage prevention portion 160, the circumferential leakage prevention portion 160 being on the inflow side of the sewing ring 150.

Referring to fig. 1f, the sewing ring 150 extends circumferentially along the stent and has a wave structure in which the portions opposite to the inflow side are wave troughs and the portions opposite to the outflow side are wave crests, the wave troughs being abutted against the leakage preventing portions 160.

After the valve is implanted, the expandable structure of the stent is used for anchoring, and the suture ring 150 and the valve annulus are used for suturing, so that stability after the valve is implanted is guaranteed, and meanwhile, the peripheral leakage prevention part 160 can play a role in blocking a gap between the valve annulus and the suture ring 150 and prevent blood from flowing through the gap.

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

The spacer region facilitates sewing of the covering film 140 and the leaflet 130, and also provides a certain deformation space for the sewing ring 150, namely, when the prosthetic valve enters the delivery system after being compressed, the deformation of the sewing ring 150 does not bring a large deformation pressure to the leaflet 130.

In one embodiment, referring to fig. 1f, 1g, 1h, and 1i, the covering film 140 includes an outer covering film 142 and is wrapped around the outer side of the stent in the radial direction, and the leakage preventing portion 160 includes a expandable material band 161 and a first portion of the outer covering film 142, where the first portion wraps the expandable material band 161.

In one embodiment, referring to fig. 1f, 1g, 1h, and 1i, the sewing ring 150 includes a band 151 of sewing material and a second portion of the outer cover 142, and the second portion encloses the band 151 of sewing material.

The outer coating 142 may have other portions in addition to the first portion and the second portion. The outer cover 142 is a unitary body with a first portion wrapping the band 161 of expandable material and a second portion wrapping the band 151 of suture material, reducing the splicing of the outer cover 142, on the one hand, for ease of processing and, on the other hand, also reducing material leakage.

The sewing material belt 151 can be made of silicone rubber, has moderate elasticity, reduces rigid extrusion to the valve annulus, is convenient for carry out the sewing process simultaneously, and the prosthetic valve is sewn on the valve annulus through 3 sewing points, so that the risk of valve displacement is reduced, and the sewing ring 150 can be well attached to the native valve annulus, so that the paravalvular leakage is reduced to a certain extent.

In one embodiment, referring to fig. 1f, 1g, 1h, and 1i, the covering film 140 includes an inner covering film 141 and is wrapped on the inner side of the stent in the radial direction, the outflow side of the inner covering film 141 is abutted to the fixing edge 132 of the leaflet 130, and both the inner covering film 141 and the outer covering film 142 are connected to the inflow side of the stent in a converging manner.

The inner and outer cover films 141 and 142 wrap the stent integrally, reducing the exposed portion.

Both the inner cover 141 and the outer cover 142 are integral membranes, or split membranes.

The inner coating and the outer coating 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 split joint between the split diaphragms is positioned on the inflow side of the bracket, or is positioned on the radial outer side of the bracket, or is positioned on the radial inner side of the bracket.

In one embodiment, as shown in fig. 1f, 1g, 1h, and 1i, the band of expandable material 161 and the band of suture material 151 are each individually wrapped entirely by the outer cover film 142 or sandwiched between the inner cover film 141 and the outer cover film 142.

Referring to fig. 1i, the suture material tape 151 extends along the circumferential direction of the stent and has a wave structure, and the inner and outer cover films 141 and 142 do not change the wave configuration of the suture material tape when wrapping the suture material tape 151, so that the resulting suture ring 150 also has a wave structure consistent with the suture material tape 151, with the position on the inflow side being a trough, the position on the outflow side being a peak, the trough being in abutment with the leakage preventing portion 160.

The expandable material belt 161 can be made of PU foaming material, and the PU foaming material has the characteristics of good elasticity and water impermeability, is favorable for being tightly attached to the valve annulus, and reduces the leakage around the valve annulus.

In one embodiment, referring to fig. 1f, 1g, 1h, and 1i, the strip 161 of swellable material comprises a substrate disposed about the periphery of the stent and a water-swellable material affixed to the substrate.

The substrate and the water-swellable material are made of polymeric materials, for example, one or more of the following: polyesters, polyethylene terephthalate (PET), polyetheretherketone (PEEK), polypropylene (PP), polytetrafluoroethylene (PTFE), polyurethane (PU), ultra High Molecular Weight Polyethylene (UHMWPE), silicone, polyoxymethylene, polyphenylsulfone, polysulfone, polyvinylidene fluoride, and polyamide. The substrate can be made of polymer materials such as PET, and the water-swelling material can be made of water-swelling materials such as hydrogel or porous foaming materials. In one embodiment, as shown in fig. 1f, 1g, 1h, 1i and 1j, the water-swelling material is in a strip shape and is continuously distributed in the circumferential direction of the stent, or is in a plurality of blocks arranged at intervals; the annular portion 120 has a grid structure, and the massive water-absorbing expansion materials respectively correspond to the hollow areas of the grid structure.

The water-absorbing expansion material is in a plurality of blocks which are arranged at intervals, and the water-absorbing expansion material in the blocks protrudes towards the radial outer side of the bracket relative to the bracket.

In one embodiment, as shown in FIG. 1j, the leakage prevention portion 160 comprises a strip of expandable material and a portion of the inner cover 141, with the strip of expandable material 161 attached to the inner cover 141.

In one embodiment, the inner cover 141 is made of an expandable material, and the expandable material 161 is integrally formed with the inner cover 141.

In one embodiment, as shown in fig. 1j, the expandable material 161 is connected to the inflow side of the inner covering film 141, and is in a plurality of blocks arranged at intervals along the circumferential direction of the stent, the annular portion has a grid structure, and the water absorbing expansion materials in the blocks respectively correspond to the hollow areas of the grid structure.

In one embodiment, referring to fig. 1f, 1g, 1h, and 1i, the sewing ring 150 is provided with threading marks 170, and the threading marks 170 are offset from the binding posts 112 in the circumferential direction of the stent. That is, the threading mark 170 is provided at the middle position of the adjacent two coupling posts 112 in the circumferential direction of the bracket.

In one embodiment, referring to fig. 2h and 2i, the dashed line is the blood flow direction, and in the loading state, the suture ring 150 has a wave structure extending along the circumferential direction of the stent:

The part opposite to the inflow side is a trough;

The opposite part on the outflow side is the peak.

The support has wave structures in both the loading state and the releasing state, and the difference is that the height difference of the wave crest and the wave trough is different.

In one embodiment, and as shown in FIGS. 2h and 2i, the sewing ring 150 carries a threading indicator 170, the threading indicator 170 being in a trough position.

The application also provides a processing method of the artificial valve, which comprises the following steps:

S100, connecting each valve leaf with the outflow side edge of the radial inner coating film of the stent to form a first prefabricated product;

s200, forming a second prefabricated product by coating the radial outer side of the bracket;

And S300, respectively connecting the first prefabricated product and the second prefabricated product to a bracket to form the artificial valve.

In one embodiment, S100, the circumferential leakage preventing portion is formed by attaching a circumferential leakage preventing material to the radially inner side of the stent, or by crimping the radially inner side of the stent.

In one embodiment, S200, a second preform is formed by wrapping a suture material with a first portion of the stent radially outer cover.

In one embodiment, S200, a second preform is formed by wrapping a leak-proof material with a second portion of the stent radially outer coating.

In one embodiment, S200, the second preform is formed by forming a seam and/or a leakage prevention portion using the folds of the stent radially outer cover.

In one embodiment, the method for manufacturing a prosthetic valve, step S300 includes:

S310, stitching the first preform to the stent, and reserving a first non-stitching region at a top end portion adjacent to the binding post 112;

S320, stitching the second preform to the stent, and reserving a second non-stitched area adjacent to the top end portion of the bond post 112;

S330, stitching and fixing the first non-stitched area and the second non-stitched area together with the bracket.

For delivering a prosthetic valve into the body, the present application also provides a delivery system, see fig. 2a, 2b, 2c, 2f, comprising:

a control handle 210 having opposite distal and proximal ends;

the valve catch 230, its own periphery has an adaptation structure 231 corresponding to the prosthetic valve;

A sleeve 220 movably disposed at the outer circumference of the valve catch 230, the sleeve 220 being switchable between a wrapped state and an exposed state in which the fitting structure 231 is exposed;

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

The proximal end of the control handle 210 is the end proximal to the operator and the distal end is the end distal to the operator.

The delivery system collapses the prosthetic valve to a small size and delivers it to the target site, as shown in fig. 2g, 2h, by connecting the prosthetic valve to the valve clasper 230 via the adapter 231 prior to the procedure, and by manipulating the control handle 210 to switch the sleeve 220 from exposing the adapter 231 to wrapping the adapter 231, the prosthetic valve is radially compressed to reduce size to accommodate placement at the small incision site.

Only the sleeve 220 and the valve catch 230 in the delivery system are close to the prosthetic valve, and the shielding is limited, the control handle 210 is far away from the prosthetic valve, so that the sight of a user is not easy to be blocked, and the state of the valve can be conveniently observed in the process of delivering the valve.

The prosthetic valve compressed in the sleeve is smaller in size, more easily passes through the sinotubular junction, and can affect the operator's field of view during the middle of the delivery procedure.

The working process of the conveying system is shown in fig. 2 g-2 m, and is specifically as follows:

Referring to fig. 2g, the sleeve 220 exposes the fitting structure 231 of the valve catch 230, and the prosthetic valve is coupled with the fitting structure 231 of the valve catch 230;

referring to fig. 2h, the sleeve 220 is manipulated by the control handle 210 to wrap the fitting structure 231, the prosthetic valve being in a compressed state;

Referring to fig. 2i, the sleeve 220 is locked in position by the control handle 210;

referring to fig. 2j, the surgeon passes the suture through the native annulus and passes the suture through the sewing ring 150 of the prosthetic valve in a compressed state, delivering the compressed prosthetic valve to the native annulus along the suture movement;

Referring to fig. 2k, the position of the sleeve 220 is unlocked by the control handle 210, and the sleeve 220 is operated to be switched from a state of wrapping the fitting structure 231 to a state of exposing the fitting structure 231, the prosthetic valve is released, and gradually switched from the loading state to the release state;

Referring to fig. 2l, the prosthetic valve is completely disengaged from the valve catch 230 and returned to its original size;

Referring to fig. 2m, the prosthetic valve is placed at the native valve annulus after complete release, the native valve annulus is sutured to the suturing ring 150 of the prosthetic valve, and the delivery system is evacuated.

To avoid affecting the field of view of the operator, the sleeve 220 may be made of a transparent material.

The two driving members can slide relatively in the axial direction so as to realize the switching between the two states of wrapping the sleeve 220 and exposing the adapting structure 231. One of the driving members is fixed relative to the control handle 210, the other driving member is axially movable, and the driving member which is axially movable can be linked with the sleeve 220 or with the valve clip 230.

In one embodiment, referring to fig. 2a, 2b and 2c, the distal end of the sleeve 220 is a flared structure, and the opening edge of the flared structure is provided with a plurality of avoidance grooves 221 arranged at intervals along the circumferential direction.

Referring to fig. 2h, the relief groove 221 may accommodate the folds of the sewing ring 150 as the prosthetic valve compresses, reducing the radial dimension of the prosthetic valve after compression.

In one embodiment, referring to fig. 2a and 2f, the sleeve 220 structure is omitted in fig. 2f, the valve buckle 230 is columnar, the adapting structure 231 is an anti-drop groove and/or an anti-drop post arranged at the periphery of the valve buckle 230, and the circumferential distribution position of the avoiding groove 221 corresponds to the adapting structure 231.

The fitting structure 231 is configured such that, in order to stably hold the prosthetic valve on the valve catch 230, the valve catch 230 and the fitting structure 231 of the prosthetic valve are complementary structures, for example, an anti-drop ear is disposed on the prosthetic valve, and an anti-drop groove corresponding to the shape of the anti-drop ear is disposed on the valve catch 230; the valve clip 230 is provided with an anti-drop groove, and an anti-drop post corresponding to the anti-drop groove is provided on the prosthetic valve.

The circumferentially distributed positions of the avoidance grooves 221 correspond to the adapting structures 231, so that the avoidance grooves 221 can better accommodate the fold parts of the prosthetic valve based on the consideration of the state of the compressed prosthetic valve.

The control handle 210 includes:

A housing 211, wherein a mounting chamber is arranged in the housing 211, and one of the two transmission members is fixed in the mounting chamber;

a moving seat 212 slidably disposed in the installation chamber, the other of the two driving members being fixed to the moving seat 212;

A shift position adjusting mechanism 213 disposed between the movable seat 212 and the installation chamber, for restricting the movable seat 212 to at least two shift positions;

The control button 214 is connected to the movable base 212, and at least a portion thereof extends to the outside of the housing 211.

In one embodiment, referring to fig. 2d and 2e, the control handle 210 includes:

A housing 211, wherein a mounting chamber is formed in the housing 211, and a transmission member is fixed in the mounting chamber;

A moving seat 212 slidably disposed in the installation chamber, and another transmission member fixed to the moving seat 212;

The control knob 214 is connected to the movement base 212, and the movement base 212 can be operated to move by pulling the control knob 214, and movement of the movement base 212 to the gear position corresponding to the gear position adjusting mechanism 213 is restricted unless an external force is applied through the control knob 214 to overcome the restriction.

The gear position adjusting mechanism 213 has at least two gear positions corresponding to the following positions, respectively:

a) A fully compressed position of the prosthetic valve;

b) The fully released position of the prosthetic valve.

In addition, the gear positions can be set corresponding to the positions of different states in the release process of the artificial valve, for example, corresponding gears are set for the state that the suture ring of the artificial valve is completely opened, when the suture ring of the artificial valve is kept in the completely opened state, the suture ring and the native valve ring are sutured by utilizing sutures, after suturing, the artificial valve is completely released, and the conveying system is withdrawn.

The full compression of the prosthetic valve does not refer to the greatest degree of compression possible with the prosthetic valve, but rather to the final state of compression that the prosthetic valve is required to achieve in the delivery system.

The shift position adjusting mechanism 213 is used for limiting the movable seat 212, so that valve falling or shifting caused by misoperation in the operation process of an operator can be avoided, and the safety of the operation process is ensured.

The gear adjusting structure includes:

A plurality of clamping grooves 215 which are arranged at intervals along the axial direction of the shell 211, wherein the clamping grooves 215 are arranged on one of the movable seat 212 and the inner wall of the shell 211;

the elastic clamping tongue 216 is arranged on the other of the movable seat 212 and the inner wall of the shell 211, and the elastic clamping tongue 216 is combined with the corresponding clamping groove 215 at different gears of the movable seat 212.

The movable base 212 is limited to different gear positions by the cooperation of the elastic clamping tongue 216 and the clamping groove 215. When the clamping groove 215 is arranged on the movable seat 212, the elastic clamping tongue 216 is arranged on the inner wall of the shell 211, or when the clamping groove 215 is arranged on the inner wall of the shell 211, the clamping groove 215 is arranged on the inner wall of the shell 211.

The number of the clamping grooves is the number of gears, each gear corresponds to the position of one movable seat, and the number of the clamping grooves can be set according to the requirement.

In one embodiment, referring to fig. 2d and 2e, the gear adjusting structure includes:

Three clamping grooves 215 which are axially arranged at intervals along the shell 211, wherein the three clamping grooves 215 are arranged on the inner wall of the shell 211;

The elastic clamping tongue 216 is disposed on the moving seat 212, and the elastic clamping tongue 216 is combined with the corresponding clamping groove 215 at different gear positions of the moving seat 212.

In one embodiment, as shown in fig. 2d and 2e, two elastic strips 217 are fixed on the moving base 212 side by side, one section of each elastic strip 217 is protruded outwards to form two elastic clamping tongues 216, and two rows of clamping grooves 215 are respectively corresponding to one elastic clamping tongue 216. In fig. 2e, one of the rows of the clamping grooves 215 is partially blocked by the housing 211.

The two rows of clamping grooves 215 are in one-to-one correspondence, and each pair of elastic clamping tongues 216 is correspondingly arranged in the corresponding clamping groove 215.

In one embodiment, referring to fig. 2d and 2e, the inner wall of the housing 211 is provided with a guiding structure 218 for guiding the moving base 212. The guiding structure 218 is a chute fixed on the inner wall of the housing 211. The housing 211 is also provided with a chute for guiding the movement of the control knob 214.

In one embodiment, referring to fig. 2d and 2e, the two driving members are each a tube member, an inner tube 241 connected to the valve clip 230, and an outer tube 242 connected to the sleeve 220, the proximal end of the outer tube 242 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 catch 230.

In one embodiment, referring to fig. 2d and 2e, a locking member 219 is movably embedded in the housing 211, and the locking member 219 can be switched between two states of interfering with and avoiding the moving seat 212.

When the prosthetic valve is in a fully compressed state, the locking piece 219 interferes with the movement of the moving seat 212, namely, the prosthetic valve is stably installed in the conveying system, misoperation is prevented in the moving process, and when the prosthetic valve needs to be released from the conveying system, the locking piece 219 is switched to a state of avoiding the movement of the moving seat 212.

In one embodiment, as shown in fig. 2d, the distal side of the moving seat 212 is provided with an L-shaped limit groove 250, and the limit groove 250 includes a longitudinal section extending along the axial direction of the housing 211 and a transverse section vertically communicating with the longitudinal section, wherein the end of the longitudinal end is an open mouth;

the locking member 219 is in the transverse and longitudinal sections, respectively, in both the interference and avoidance movement seat 212.

In the process of switching the prosthetic valve from the non-compressed state to the fully compressed state, the locking piece 219 enters the longitudinal section through the opening, when the prosthetic valve reaches the fully compressed state, the locking piece 219 is positioned at the junction of the longitudinal section and the transverse section, the locking piece 219 is stirred along the transverse section, the locking piece 219 is far away from the longitudinal section, and the movement of the movable seat 212 is limited due to the interference between the locking piece 219 and the transverse section in the movement direction of the movable seat 212.

When the prosthetic valve is to be released, the locking member 219 is shifted along the transverse segment so that the locking member 219 is positioned within the longitudinal segment, and the locking member 219 is movable along the longitudinal segment in the direction of movement of the movable seat 212 to release the movement restriction of the movable seat 212.

Referring to FIG. 2b, the length of the delivery system (i.e., the sum of the dimensions of D1 and D2) is 300-400 mm. The artificial valve conveyed by the conveying system is not an intervention valve or a surgical valve, the length of the conveying system is between the conveying systems, the length D1 of a control handle in the conveying system is 100-150 mm, the length D2 of the rest parts except the control handle is 150-300 mm, the size D3 of the sleeve end is 15-20 mm, and the width D4 of the control handle is 15-30 mm.

The using method of the conveying system comprises the following steps:

the control handle driving sleeve is in a state of wrapping the adapting structure,

The outflow side of the artificial valve gathers radially inwards, and the inflow side is flared;

When the control handle drives the sleeve in a state of wrapping the fitting structure, see fig. 2h, the prosthetic valve is only supported inside the sleeve, the annular portion is not completely received by the sleeve, and the inflow side of the annular portion is still outside the sleeve.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims

A prosthetic valve system, the prosthetic valve system comprising a cooperating prosthetic valve and a delivery system, the prosthetic valve comprising: the support, set up the lamella leaf on the support, attach the tectorial membrane on the support, the inside blood flow passageway that encloses of support, support have relative inflow side and outflow side, the support includes:

The support part is surrounded by a plurality of U-shaped frames, the opening of each U-shaped frame faces the outflow side, the side edges of two adjacent U-shaped frames are adjacent to each other to form a combination column, and the side edges of the two adjacent U-shaped frames are intersected to the top end of the combination column;

An annular part which is a grid structure deformable in the radial direction and is positioned on the inflow side of the supporting part as a whole;

The conveying system includes:

a control handle having opposite distal and proximal ends;

The periphery of the valve buckle is provided with an adapting structure corresponding to the supporting part of the artificial valve;

the sleeve is movably arranged at the periphery of the valve buckle, and the sleeve can be switched between two states of wrapping and exposing the adapting structure;

when the sleeve is in a state of wrapping the adapting structure, the artificial valve is in a loading state that the outflow side is gathered inwards in the radial direction and the inflow side is flared;

When the sleeve is in a state of exposing the adapting structure, the artificial valve is in a release state of a straight cylinder structure, wherein the outflow side of the artificial valve is expanded outwards in a radial direction;

The valve buckle and the sleeve are respectively connected to the farthest ends of the two transmission parts, the proximal ends of the two transmission parts are connected to the control handle, and at least one transmission part is in movable fit with the control handle so as to adapt to the state switching of the sleeve.
The prosthetic valve system of claim 1, wherein a periphery of the stent is provided with a sewing ring.
The prosthetic valve system of claim 2, wherein the stent is peripherally surrounded by an annular leak-proof portion, the leak-proof portion being on an inflow side of the sewing ring.
The prosthetic valve system of claim 3, wherein the sewing ring extends circumferentially about the stent and has a wave configuration with valleys on the inflow side and peaks on the outflow side, the valleys abutting the peripheral leak prevention portion.
The prosthetic valve system of claim 2, wherein the sewing ring is on an inflow side of the U-shaped frame with a spacer left between the sewing ring and the U-shaped frame.
The prosthetic valve system of claim 3, wherein the covering comprises an outer covering that is wrapped radially outward of the stent, the perileak prevention portion comprises a band of expandable material and a first portion of the outer covering, and the first portion wraps around the band of expandable material.
The prosthetic valve system of claim 6, wherein the outer cover is made of PET material.
The prosthetic valve system of claim 7, wherein the sewing ring comprises a band of sewing material and a second portion of the outer cover, and the second portion wraps around the band of sewing material.
The prosthetic valve system of claim 7, wherein each leaflet has a fixed edge connected to a U-shaped frame and a free edge that cooperates with other petals She Xiangpei to vary the degree of patency of a blood flow path, the cover comprising an inner cover that is wrapped radially inward of the stent, an outflow side of the inner cover being butted to the fixed edge of the leaflet, both the inner cover and the outer cover being joined to an inflow side of the stent.
The prosthetic valve system of claim 9, wherein the inner and outer cover membranes are integral or split membranes.
The prosthetic valve system of claim 8, wherein the band of expandable material and the band of suture material are each independently entirely wrapped by the outer cover or sandwiched between the inner and outer covers.
The prosthetic valve system of claim 6, wherein the band of swellable material is a band of water-swellable material and is continuously distributed circumferentially about the stent, or is a plurality of blocks arranged at intervals; the annular part is provided with a grid structure, and the blocky water-absorbing expansion materials are respectively corresponding to the hollow areas of the grid structure.
The prosthetic valve system of claim 6, wherein the band of expandable material comprises a base disposed about a periphery of the stent and a water-swellable material secured to the base.
The prosthetic valve system of claim 2, wherein the sewing ring carries threading indicia thereon that are offset from the commissure posts in the circumferential direction of the stent.
The prosthetic valve system of claim 4, wherein the sewing ring carries a threading indicator thereon, the threading indicator being in a trough position.
The prosthetic valve system of claim 1, wherein the valve clasper is cylindrical and the adapter structure is an anti-slip groove and/or an anti-slip post disposed on a periphery of the valve clasper.
The prosthetic valve system of claim 1, wherein the control handle comprises:

A housing, in which a mounting chamber is formed, one of the two transmission members being fixed to the mounting chamber;

A moving seat slidably disposed in the installation chamber, the other of the two transmission members being fixed to the moving seat;

a shift position adjusting mechanism arranged between the movable seat and the installation chamber and limiting the movable seat to at least two shift positions;

and a control button connected with the movable seat and at least one part of which extends to the outside of the shell.
The prosthetic valve system of claim 1, wherein the distal end of the sleeve is a flared structure, an opening edge of the flared structure is provided with a plurality of relief grooves circumferentially spaced apart, and circumferentially distributed locations of the relief grooves correspond to the adapter structure.
The prosthetic valve system of claim 17, wherein the shift adjustment structure comprises:

The clamping grooves are arranged at intervals along the axial direction of the shell and are arranged on one of the movable seat and the inner wall of the shell;

The elastic clamping tongue is arranged on the other one of the movable seat and the inner wall of the shell, and is combined with the corresponding clamping groove when the movable seat is in different gears.
The prosthetic valve system of claim 19, wherein the mobile seat has two resilient strips secured side-by-side, one of the resilient strips protruding outwardly away from the other to form two resilient tabs, the two rows of slots corresponding to one of the resilient tabs.
The prosthetic valve system of claim 17, wherein the housing is removably nested with a locking member that is switchable between two states of interference and avoidance with the mobile seat.
The prosthetic valve system of claim 21, wherein the distal side of the mobile seat is provided with an L-shaped limiting groove comprising a longitudinal section extending axially along the housing and a transverse section in perpendicular communication with the longitudinal section, wherein the longitudinal end is open ended;

the locking piece is respectively arranged at the transverse section and the longitudinal section in two states of interference and avoidance of the movable seat.
The prosthetic valve system of claim 1, wherein the delivery system has a length of 300-400 mm.
Use of a delivery system according to any one of claims 1 to 23, comprising the steps of:

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

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

The control handle drives the sleeve to be in a state of wrapping the adapting structure, the outflow side of the artificial valve is gathered radially inwards, and the inflow side is flared;

The control handle drives the sleeve to be in a state of releasing the adapting structure, the outflow side of the artificial valve is separated from the adapting structure and expands outwards in a radial direction, and the artificial valve is in a straight cylinder structure as a whole.