CN118252669A

CN118252669A - Prosthetic valve, clamping device of prosthetic valve and packaging system

Info

Publication number: CN118252669A
Application number: CN202311764351.5A
Authority: CN
Inventors: 章合强; 郭月
Original assignee: Jilin Qiming Haoyue Biotechnology Co ltd
Current assignee: Jilin Qiming Haoyue Biotechnology Co ltd
Priority date: 2022-12-28
Filing date: 2023-12-20
Publication date: 2024-06-28

Abstract

The present application provides a prosthetic valve having opposite inflow and outflow sides, comprising: the inside blood flow channel that encloses of support, support includes: the support part is formed by encircling a plurality of U-shaped frames, the opening of each U-shaped frame faces to the outflow side, the side edges of two adjacent U-shaped frames are adjacent to each other to form a combined column, the side edges of the two adjacent U-shaped frames are intersected to the top end of the combined column, and a connecting strip which can conform to the mutual approaching of the side edges of the U-shaped frames is arranged between the two opposite side edges of each U-shaped frame; an annular part which is of a grid structure deformable in the radial direction and is integrally positioned on the inflow side of the supporting part, and the annular part is connected with the inflow side of the U-shaped frame; a plurality of petals, each of which has a fixed edge connected to the U-shaped frame and a free edge that cooperates with the other petals She Xiangpei to change the opening degree of the blood flow channel; and the coating film is coated on the radial inner side and/or the radial outer side of the bracket.

Description

Prosthetic valve, clamping device of prosthetic valve and packaging system

Technical Field

The application relates to the technical field of medical appliances, in particular to a prosthetic valve, a clamping device of the prosthetic valve and a packaging system.

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.

In the prior art, surgical valve products with minimally invasive small incisions are few, and although the problems caused by suturing can be solved, the delivery performance and the release performance are still required to be improved.

Disclosure of Invention

Aiming at the implantation problem of the artificial valve, the artificial valve has better conveying performance and can be quickly restored to a release state from a loading state when being implanted.

A prosthetic valve having opposite inflow and outflow sides, comprising:

The inside blood flow channel that encloses of support, support includes:

the support part is formed by encircling a plurality of U-shaped frames, the opening of each U-shaped frame faces to the outflow side, the side edges of two adjacent U-shaped frames are adjacent to each other to form a combined column, the side edges of the two adjacent U-shaped frames are intersected to the top end of the combined column, and a connecting strip which can conform to the mutual approaching of the side edges of the U-shaped frames is arranged between the two opposite side edges of each U-shaped frame;

An annular part which is of a grid structure deformable in the radial direction and is integrally positioned on the inflow side of the supporting part, and the annular part is connected with the inflow side of the U-shaped frame;

a plurality of petals, each of which has a fixed edge connected to the U-shaped frame and a free edge that cooperates with the other petals She Xiangpei to change the opening degree of the blood flow channel;

and the coating film is coated on the radial inner side and/or the radial outer side of the bracket.

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, the end of the connecting strip is fixedly connected with the side edge of the U-shaped frame, and the connecting part is adjacent to the top end of the binding post.

Optionally, the frame strip strength of the connecting strip is smaller than the frame strip strength of the U-shaped frame.

Optionally, each U-shaped frame is correspondingly provided with a connecting strip, the middle part of the connecting strip is provided with a bending part, and the bending part protrudes towards the bottom of the U-shaped frame.

Optionally, the bending angle of the bending part of the connecting strip is 45-120 degrees.

Optionally, the connecting strip is V-arrangement, and the both sides limit of V-arrangement is connected with the corresponding side of U-shaped frame respectively, and the kink department of V-arrangement connecting strip has the fillet structure.

Optionally, the bracket is formed by integrally cutting a pipe body, and the connecting strip is coplanar with the peripheral surface of the pipe body, or the connecting strip is tilted outwards relative to the peripheral surface of the pipe body.

Optionally, the frame strip strength of the U-shaped frame is greater than the frame strip strength of the annular portion.

Optionally, the top end of the coupling post widens in the circumferential direction of the bracket to form a connecting lug for adapting to the delivery system.

Optionally, one or more contact bars are arranged between the side edges of two adjacent U-shaped frames, and the contact bars enclose one or more hollowed-out windows at the joint column positions.

Optionally, the connecting strip is closer to the top of the binding post than the hollowed-out window is to the part connected with the side edge of the U-shaped frame.

Optionally, the grid structure of the annular portion is a circumferentially arranged cell, and the annular portion has a plurality of end nodes located at an inflow end and an outflow end.

Optionally, an end node of the outflow end of the at least one annular portion is connected as a connecting portion to the bottom of the U-shaped frame.

Optionally, the cells between adjacent connection portions are not connected to the U-shaped frame.

Optionally, end nodes spanning 3-5 outflow ends between adjacent connection portions.

Optionally, the end nodes of the inflow end and the end nodes of the outflow end form at least one row of axially distributed cells.

Optionally, each cell of the annular portion in the circumferential direction is a complete cell, or at least one cell is an incomplete cell.

Optionally, the incomplete cell is a V-shaped frame bar.

Optionally, each complete cell of the annular portion is substantially diamond-shaped or hexagonal.

Optionally, the connection part between the annular part and the supporting part is multiple.

Optionally, the connection part of the annular part and each U-shaped frame is a plurality of parts, and at least a part of cell vertexes of the annular part are connected with the U-shaped frames.

Optionally, the axial height of the bracket is 22-28 mm.

Optionally, the diameter ratio of the prosthetic valve before and after crimping is 1:1.3 to 1.6.

Optionally, the outer periphery of the support is surrounded by an annular peripheral leakage prevention part and/or a sewing ring.

Optionally, along the outflow direction of blood flow direction, the periphery of support is around having annular peripheral leakage prevention portion and the sewing ring that distributes in proper order, the sewing ring extends along support circumference and has the wave structure, and the position that is located the inflow relatively is the trough, and the position that is located the outflow relatively is the crest.

Optionally, the peripheral leakage prevention part and the sewing ring are formed by wrapping the same covering film.

Optionally, the trough and the leakage preventing part of the sewing ring are close to each other.

Optionally, the fixed edge of the valve leaflet extends along the circumferential direction of the blood flow channel to form an ear protector, and a stress release opening is arranged between the ear protector and the fixed edge.

Optionally, a plurality of suture holes are formed in the fixing edge, positioning holes are formed in the adjacent positions of the lug and the fixing edge, and connecting lines of the positioning holes and at least one suture hole pass through the stress release opening.

Optionally, the ear protector is rectangular, and the positioning hole is located in the middle of the rectangular width direction.

The present application provides a prosthetic valve comprising:

A stent, the stent interior enclosing a blood flow channel, the stent having opposite inflow and outflow sides, the stent comprising:

The support part comprises a plurality of first U-shaped frames and second U-shaped frames, the openings of the first U-shaped frames face the outflow side, the side edges of the two adjacent first U-shaped frames are adjacent to each other to form a combined column, the side edges of the two adjacent first U-shaped frames are intersected to the top end of the combined column, each first U-shaped frame is internally connected with one second U-shaped frame, and the openings of the second U-shaped frames face the outflow side;

The annular part is of a grid structure capable of deforming in the radial direction and is integrally positioned on the inflow side of the supporting part, the bottom of the first U-shaped frame is connected with the annular part, and a gap is reserved between the bottom of the second U-shaped frame and the annular part;

a plurality of petals, each of the petals having a fixed edge connected to the first U-shaped frame and a free edge that cooperates with the other petals She Xiangpei to change the degree of openness of the blood flow channel;

The artificial valve prepared by the bracket of the artificial valve is implanted in a body in a surgical operation mode, and in the implantation process, the artificial valve is in a partially compressed state and can be automatically expanded to a use state after implantation.

In order to keep the position of the artificial valve structure in the packaging structure stable, a retaining device matched with the artificial valve is arranged in the packaging structure, and the artificial valve and the retaining device are taken out from the packaging structure together when in use and then separated.

The existing retaining device and the artificial valve are generally matched with each other in a tight fit mode or a mode of arranging a release switch, and the like, but in some cases, the retaining device and the artificial valve are separated due to some misoperation, so that the artificial valve is possibly damaged or polluted.

In view of the problems of the prior art, the present application provides a prosthetic valve clamping device and packaging system that securely retains a prosthetic heart valve within the packaging system and is easy to remove during use.

The present application provides a prosthetic valve clamping device comprising:

The support body is provided with a positioning groove for receiving the artificial valve;

The locking piece is in running fit with the support body, the locking piece is provided with a blocking part which is matched with the positioning groove to limit the detachment of the interventional instrument and a handle part which is used for driving the locking piece to integrally rotate, the locking piece is provided with a first state and a second state which are opposite in the rotating process of the locking piece relative to the support body, the blocking part seals a part of openings of the positioning groove to limit the detachment of the artificial valve in the first state, and the blocking part opens the positioning groove to allow the artificial valve to be detached from the positioning groove in the second state.

The present application also provides a prosthetic valve clamping device comprising:

the locking piece is movably matched with the support body, and has a first state and a second state which are opposite to each other in the movement process of the locking piece relative to the support body, wherein in the first state, a part of openings of the positioning grooves are closed to limit the detachment of the interventional instrument, and in the second state, the positioning grooves are opened to allow the detachment of the interventional instrument from the positioning grooves;

And the safety lock acts between the locking piece and the supporting body to limit the movement of the locking piece relative to the supporting body.

The locking piece is in running fit with the support body and is provided with a blocking part matched with the positioning groove to limit the detachment of the interventional instrument and a handle part used for driving the locking piece to integrally rotate;

And the safety lock acts between the handle and the supporting body to limit the rotation of the locking piece.

Optionally, the support body includes an annular portion, the constant head tank has a plurality of and interval distribution in the annular portion, the annular portion has relative topside and bottom side, the constant head tank is opened in annular portion bottom side, and the prosthetic valve is in annular portion bottom side under the adaptation state.

Optionally, the locking member includes:

a main body rotatably installed at a middle region of the ring portion;

the handle is connected to the main body and exposed to the top side of the annular portion;

The blocking part is connected with the other end of the main body, is fixed on the main body and extends to the bottom of the annular part.

Optionally, the prosthetic valve includes a support and a leaflet mounted in the support, one axial end of the support is provided with a connecting lug, and a combining groove of a clamping blocking part is arranged at a position adjacent to the connecting lug of the support.

Optionally, the handle portion is provided with a mounting hole at the top side of the annular portion, the safety lock is slidably inserted into the mounting hole, and the top side of the annular portion is provided with a limiting portion for receiving the safety lock.

Optionally, the top side of the annular portion forms an expansion portion radially outwards, and the limiting portion is a clamping groove arranged on the top side of the expansion portion.

Optionally, a barrier strip extending along the circumferential direction of the annular portion is arranged on the top side of the annular portion, and one part of the barrier strip is a discontinuous area and serves as the clamping groove.

Optionally, the safety lock has a rotation-stopping state inserted into the clamping groove and an unlocking state separated from the clamping groove and allowing the locking piece to integrally rotate; in the unlocked state, the inner side of the barrier strip limits the radial position of the safety lock.

Optionally, the safety lock is a bolt, the bolt has its own length direction, and the both ends of length direction extend the locking piece respectively and are put in the top surface of supporter.

Optionally, one end of the latch is provided with an operation part protruding upwards.

Optionally, the latch is matched with the clamping groove through one end where the operation part is located.

Optionally, the connecting ear has a neck and an end that is enlarged relative to the neck, the end is located in a corresponding positioning groove in the fitted state of the prosthetic valve, and the blocking portion closes a part of the opening of the positioning groove;

The end of the neck part, which is far away from the end socket, is provided with a shoulder part, and the combining groove is formed between the shoulder part and the end socket.

Optionally, the positioning groove has a closing-in structure, and in the fitted state, the closing-in structure restricts at least a portion of the tip.

Optionally, the blocking part is a blade with radiation distributed on the main body, and the edge part on one side of the blade along the circumferential direction of the annular part blocks the opening of the positioning groove.

Optionally, the blade abuts against a bottom surface of the annular portion.

Optionally, in the fitted state, the blocking portion and the closing-in structure are distributed on two sides of the neck portion along the circumferential direction of the annular portion, and simultaneously limit the tip.

Optionally, the bottom surface of the annular part is provided with a limiting step, and the blocking part is provided with a first movement direction for sealing the positioning groove and a second opposite movement direction along the self movement path; and the limit position in the second movement direction is blocked by the limit step.

The application also provides a packaging system of the artificial valve, which comprises an inner box and an outer box which are sleeved in turn from inside to outside, wherein the inner box is matched with the outer box in a positioning way; the inner case includes:

The first box body is provided with a bottom and a top which are opposite, the top is provided with a first opening, a cavity for accommodating the artificial valve is arranged in the first box body, a first step for placing the artificial valve and a second step higher than the first step are distributed on the inner wall of the first box body in a ring manner;

The cover plate is positioned at the top of the cavity, and the edge of the cover plate is movably arranged on the second step;

A first sealing film closing the first opening.

Optionally, the edge shape of the cover plate is matched with the inner wall of the first box body at a preset angle in the circumferential direction.

Optionally, the second steps are provided with multiple stages, and the cover plate is provided with multiple bends distributed at different heights and is respectively matched with the second steps at all stages.

Optionally, the inner wall of the first box body is further provided with an anti-falling protrusion above the second step, and the anti-falling protrusion limits the top surface of the cover plate.

Optionally, the top surface of the second step is provided with a first sunk avoidance area, and the edge of the cover plate is provided with a first notch at a position corresponding to the position of the first avoidance area.

Optionally, the first recess has two positions and is located on two opposite sides of the first case in the width direction.

Optionally, an annular sedimentation area is arranged on the bottom surface of the first box body, so that the bottom end of the artificial valve is avoided.

Optionally, the outer box comprises a second box body and a second sealing film which are matched with each other, and a third step is arranged on the inner wall of the second box body;

the top opening of the first box body is provided with a flanging, the flanging is lapped on the third step, and the edge of the first sealing film is fixedly attached to the top surface of the flanging.

Optionally, the shape of the edge of the outward flange is uniquely matched with the inner wall of the second case in the circumferential direction.

Optionally, a plurality of spacing protrusions are distributed on the outer wall of the first box body at intervals along the circumferential direction, and each spacing protrusion abuts against the inner wall of the second box body.

Optionally, the top surface of the third step is provided with a sunk second avoidance area, and the edge of the outward flange is provided with a second notch at a position corresponding to the position of the second avoidance area.

Optionally, the second avoidance area has two positions, and is located at two opposite sides of the second box body along the width direction.

Optionally, the packaging system further comprises a packaging bag located outside the outer box;

The first sealing film and the second sealing film are made of breathable and waterproof materials;

the packaging bag is made of a material which is not breathable and not permeable to water.

Optionally, the prosthetic valve is a dry valve.

Optionally, the packaging system further comprises a sensing element for acquiring temperature and/or humidity information and a corresponding display element.

Compared with the prior art, the safety lock is used as the two-way lock of the clamping device, so that the accidental rotation of the locking piece can be prevented, and the safety of the artificial valve in the transportation process can be improved; when the artificial valve is taken, the limit of the safety lock on the locking piece is released, and the locking piece can be allowed to rotate until the artificial valve can be separated from the positioning groove.

Drawings

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

FIG. 1b is a schematic view of a holder for an artificial valve (another view);

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

FIG. 1d is a schematic view of a holder for an artificial valve (another view);

FIG. 1e is a schematic view of a stent of another embodiment prosthetic valve;

FIG. 2a is a schematic view of a stent of another embodiment prosthetic valve;

FIG. 2b is a front view of a stent of another embodiment prosthetic valve;

FIG. 2c is a schematic view of a stent with attached leaflets of another embodiment prosthetic valve;

FIG. 2d is a schematic illustration of a stent with attached leaflets of another embodiment prosthetic valve;

FIG. 2e is a schematic view of another embodiment prosthetic valve;

FIG. 2f is a schematic view of another embodiment prosthetic valve (with the attachment straps omitted);

FIG. 2g is a schematic view of another embodiment prosthetic valve;

FIG. 2h is an exploded view of another embodiment prosthetic valve;

FIG. 2i is a schematic view of a leak-proof portion of another embodiment prosthetic valve;

FIG. 2j is a schematic view of an integrated peripheral leakage prevention portion and inner cover film structure of another embodiment prosthetic valve;

FIG. 3 is a partial schematic view of a leaflet;

FIG. 4 is a schematic illustration of the outer cover wrapping the leak-proof material strip and the stitching material strip and completed stitching;

FIG. 5 is a schematic illustration of an outer covering film wrapping a U-shaped frame and completed sewing (no leaflets have been sewn);

FIG. 6a is a schematic view of a first position and a second position on an outer cover;

FIG. 6b is a schematic view of the outer covering film from a first position to a second position;

FIG. 6c is a schematic illustration of the outer covering film in a first position and a second position overlapping;

FIG. 6d is a schematic view of the outer cover in a first position and a second position;

FIG. 6e is a schematic view of the outer cover in a second position toward the first position;

FIG. 6f is a schematic view of the outer cover in a second position toward the first position;

FIG. 6g is a schematic illustration of the first and second locations on the outer cover being coincident;

FIG. 7a is a schematic view of the valve holder beginning loading of a prosthetic valve;

FIG. 7b is a schematic view of the valve holder fully loaded with a prosthetic valve;

FIG. 7c is a schematic view of the valve holder fully loaded with the prosthetic valve and the locking member locked;

FIG. 7d is a schematic illustration of the valve holder placing a prosthetic valve into the native annulus;

FIG. 7e is a schematic illustration of the valve holder placing a prosthetic valve into the native annulus with the sewing ring fully deployed;

FIG. 7f is a schematic view of the valve holder fully releasing the prosthetic valve;

Fig. 7g is a schematic view of the artificial valve after implantation in a human body.

FIG. 8 is a schematic view of an assembly process of a clamping device according to an embodiment;

FIG. 9 is a schematic view of an assembly of a clamping device according to another embodiment;

FIG. 10 is a schematic view showing a structure of a clamping device assembled in one embodiment;

FIG. 11 is a schematic view of the structure of the clamping device after the safety lock is in place;

FIG. 12 is a schematic view of the structure of FIG. 11 at another angle;

FIG. 13 is an enlarged view of portion A of FIG. 12;

FIG. 14 is a schematic view of a safety lock slide in one embodiment;

FIG. 15 is a schematic view of a security lock rotation in one embodiment;

FIG. 16 is a schematic view of an assembly process of the clamping device and the prosthetic valve according to one embodiment;

FIG. 17 is an enlarged view of portion A of FIG. 16;

FIG. 18 is an enlarged view of portion B of FIG. 16;

FIG. 19 is a schematic view of an artificial valve intervention gripping device in an embodiment;

FIG. 20 is a diagram showing the rotation of the safety lock according to one embodiment;

FIG. 21 is a sliding process diagram of a security lock in one embodiment;

FIG. 22 is a view showing the clamping device and prosthetic valve in a first state according to one embodiment;

fig. 23 is an enlarged view of a portion a in fig. 22;

FIG. 24 is a schematic view of a connecting ear insertion positioning groove according to an embodiment;

FIG. 25 is a schematic view of an embodiment of a connecting ear entering a closing-in structure;

FIG. 26 is a schematic view of a retaining portion and a crimping structure clamping attachment ear according to an embodiment;

FIG. 27 is a schematic view showing the cooperation of the blocking portion and the coupling groove in an embodiment;

FIG. 28 is a schematic view of a packaging system according to one embodiment;

FIG. 29 is a schematic view of a portion of a packaging system according to one embodiment;

FIG. 30 is an exploded view of FIG. 29;

FIG. 31 is a partially exploded view of FIG. 29;

FIG. 32 is a schematic diagram of a second case according to an embodiment;

FIG. 33 is a schematic view of a first case incorporating a prosthetic valve according to an embodiment;

FIG. 34 is a schematic view showing the structure of an inner case according to an embodiment;

Fig. 35 is a partial cross-sectional view of fig. 29.

In the figure: 110. a support part; 111. a U-shaped frame; 112. a binding column; 113. a connection end; 114. a connecting lug; 114a, ends; 114b, a neck; 114c, grooves; 114d, shoulders; 115. a contact bar; 116. a hollowed-out window; 117. a connecting strip; 118. a first U-shaped frame; 119. a second U-shaped frame; 120. an annular portion; 121. v-shaped frame strips; 130. valve leaves; 131. free edges; 132. a fixed edge; 133. ear protection; 134. stitching the hole; 135. positioning holes; 136. a stress relief port; 140. coating a film; 141. an inner coating film; 142. an outer coating film; 143. a receiving chamber; 150. a sewing ring; 151. stitching the strip of material; 160. a leakage prevention part; 161. a circumferential leakage prevention material belt; 170. and (5) threading a mark.

20. A clamping device; 21. a support body; 211. an annular portion; 2111. a positioning groove; 2112. a limit step; 212. an expansion section; 213. a barrier strip; 214. a limit part; 215. a through hole; 216. a closing-in structure; 217. a side edge; 22. a locking member; 221. a blocking portion; 222. a handle; 2221. a mounting hole; 223. a main body; 23. a safety lock; 231. an operation unit; 232. a sliding part;

30. A prosthetic valve; 31. a connecting lug; 311. a neck; 312. an end head; 32. a bracket; 321. a shoulder; 33. a coupling groove;

40. An inner case; 41. a first case; 411. a first step; 412. a second step; 4121. a second step A; 4122. a second step B; 413. an anti-falling protrusion; 414. a flanging; 4141. a side edge; 415. a second notch; 416. a first avoidance zone; 417. a limit protrusion; 418. a settling zone; 42. a cover plate; 421. a first recess;

50. an outer case; 51. a second case; 511. a third step; 512. a second avoidance zone;

60. And (5) packaging bags.

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.

The present application provides a prosthetic valve, as shown in fig. 2e, 2f, 2g, 2h, 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 into the human body, the sewing ring 150 is used to suture with the native valve annulus to fix the position of the prosthetic valve.

During implantation, intercostal implantation channel-shaped heart valve replacement is selected, pain to a patient caused by median sternotomy is avoided, and in addition, for the patient with smaller sinus canal joint diameter, the implantation difficulty is reduced. The valve can be compressed to 16mm in the radial direction, the difficulty of descending the valve to the valve annulus is reduced, the incision length of the body surface of a patient is controlled to be 4-6 cm, the requirement for placing the stent can be met, the incision length is far smaller than 20cm required by the implantation of a traditional surgical valve, the suturing times are reduced, the blocking time is saved, and the damage to the root of the aorta of the patient is reduced.

The valve is compressed in a sleeve of the delivery catheter system, delivered through the incision to the implantation site, and released by retracting the sleeve. Because the bracket adopts the self-expansion bracket, the artificial valve is mainly fixed at the native valve annulus by means of radial force generated after the bracket is expanded after being implanted into a human body, balloon dilatation is not needed, the complexity of operation is reduced, and in order to further increase the anchoring force of the bracket, a small amount of suturing can be carried out on the suture ring and the native valve annulus of the human body during implantation, for example, 3 needles are sutured on the circumference of the suture ring, so that the suture ring is firmly attached to the native valve annulus of the human body, and the anti-displacement risk during valve implantation is solved. The design of the sewing ring ensures that the valve related to the application inherits the advantages of surgical artificial valves, such as extremely low shift risk, low coronary artery blocking risk, capability of cutting out diseased native valve leaflets and wide application.

Referring to fig. 1a, 1b, a stent for a prosthetic valve, as exemplified by a prosthetic aortic valve stent, the stent having opposite inflow and outflow sides, comprising:

the support part 110 is formed by enclosing a plurality of U-shaped frames 111, the opening of each U-shaped frame 111 faces the outflow side (the dotted line in fig. 1a is the blood flowing direction), the side edges of two adjacent U-shaped frames 111 are adjacent to each other to form a combination column 112, the side edges of two adjacent U-shaped frames 111 are intersected to the top end of the combination column 112, and a connecting strip 117 which can conform to the mutual approaching of the side edges of the U-shaped frames is arranged between the two opposite side edges of each U-shaped frame; when the partially compressed prosthetic valve is required to be automatically expanded to a non-compressed state after delivery to the target site, the attachment straps 117 are provided to transmit force in the circumferential direction to facilitate the automatic expansion of the prosthetic valve to the non-compressed state.

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 the connection portions between the annular portion 120 and the support portion 110 are plural and correspond to the bottoms of the respective U-shaped frames 111 on the inflow side.

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.

In some examples, the stent of the prosthetic valve, as shown in fig. 1e, comprises: the supporting part 110 comprises a plurality of first U-shaped frames 118 and second U-shaped frames 119, wherein the first U-shaped frames 118 are provided with a plurality of openings facing the outflow side, the side edges of two adjacent first U-shaped frames 118 are adjacent to each other to form a combined column 112, the side edges of the two adjacent first U-shaped frames 118 are intersected to the top end of the combined column 112, each first U-shaped frame 118 is internally connected with one second U-shaped frame 119, and the opening of the second U-shaped frame 119 faces the outflow side;

the annular portion 120 is a radially deformable mesh structure and is integrally located on the inflow side of the support portion 110, the bottom of the first U-shaped frame 118 is connected to the annular portion 120, and the bottom of the second U-shaped frame 119 is spaced from the annular portion 120.

In one embodiment, referring to fig. 1a, 1b, 7b, the valve has opposite loading (i.e. loading onto a delivery system, such as a valve holder) and release states, and correspondingly the stent also has opposite loading and release states, wherein:

In the loaded state, the outflow side of the support portion 110 converges radially inward, the annular portion 120 flaring toward the inflow side as a whole;

In the released state, the outflow side of the support portion 110 expands radially outwardly, and the stent is generally of a straight cylindrical configuration.

The connecting strip 117 can provide certain radial supporting capability on one hand, and can conform to the radial inward gathering of the U-shaped frame during pressing and holding on the other hand, even drive the U-shaped frame to gather radially inwards, so that the pressing and holding performance is improved.

Referring to fig. 1a and 1b, the end of the connecting strip 117 is fixedly connected to the side of the U-shaped frame 111, and the connection portion is adjacent to the top end of the binding post.

The end of the connecting strip 117 is connected to the side of the U-shaped frame and the connecting part is adjacent to the top end of the binding post, the connecting strip applies force to the top end of the binding post, namely to the opening of the U-shaped frame, the force required for expanding the U-shaped frame is smaller, and the automatic expansion of the artificial valve bracket is more facilitated.

Referring to fig. 1a and 1b, each U-shaped frame 111 is correspondingly provided with a connecting strip 117, and the middle part of the connecting strip 117 is provided with a bending part, and the bending part protrudes towards the bottom of the U-shaped frame 111.

The connecting strip is approximately V-shaped, the bending direction of the V-shaped is the same as that of the U-shaped frame, when the support of the artificial valve is changed from a non-compressed state to a radial compressed state, the two side edges of the connecting strip are mutually close and accumulate potential energy, when the support of the artificial valve is restored to the non-compressed state from the radial compressed state, the potential energy accumulated by the connecting strip is released, the connecting strip is restored to an initial angle, and simultaneously, the two side edges of the auxiliary U-shaped frame are opened and restored to the non-radial compressed state.

Referring to fig. 1a and 1b, the connecting strip 117 is fixedly connected with the U-shaped frame 111, and the fixing manner may be welding or the like. Of course, the connecting strip 117 and the U-shaped frame 111 may be integrally formed to ensure the connection strength. For example, the connecting strip 117 and the U-shaped frame 111 may be integrally cut from a tube.

The frame strip strength of the connecting strip 117 is smaller than that of the U-shaped frame 111. The connecting strip 117 is used to assist in the deformation of the U-shaped frame and is therefore itself more prone to deformation relative to the U-shaped frame, i.e. the connecting strip 117 does not provide a greater resistance than the U-shaped frame when the prosthetic valve holder is switched from the non-compressed state to the radially compressed state, and the connecting strip 117 is deformed in preference to the U-shaped frame when the prosthetic valve holder is switched from the radially compressed state to the non-compressed state, thereby urging the U-shaped frame to return to the uncompressed state.

Referring to fig. 1b, the bending angle a of the bending portion of the connecting strip 117 is 45 to 120 degrees.

The bending angle of the bending portion of the connecting strip 117 is strictly an angle in space, where the angle is a simplified angle, that is, the angle of the connecting strip 117 near the tangential direction of the bending portion, which reflects the approximate angle range of the two sides of the connecting strip 117.

Referring to fig. 1b, the connecting strip 117 is V-shaped, two sides of the V-shape are respectively connected with corresponding sides of the U-shaped frame, and a corner bending part of the V-shaped connecting strip 117 has a rounded corner structure. The fillet structure can avoid stress concentration at the bending part, and can better adapt to the change in the process that the two side edges of the V shape are repeatedly close to and far away from each other, so that the fillet structure is not easy to break.

Referring to fig. 1d, the bracket is integrally cut from a tube body, and the connection bars 117 are coplanar with the circumferential surface of the tube body or the connection bars 117 are tilted outward with respect to the circumferential surface of the tube body.

The connecting strips 117 are tilted outwards relative to the circumference of the tube body, so that the petals She Kaige are prevented from being influenced by the contact of the connecting strips with the petals.

In fig. 1a and 1b, the stent of the prosthetic valve is in a released state, the stent is in a straight cylindrical structure as a whole, in fig. 7b, 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 flared towards the outflow side in an adaptive manner.

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.

In one embodiment, as shown in fig. 1a and 1b, three U-shaped frames 111 are provided, the bottom (i.e. turning part) of each U-shaped frame 111 at the inflow side is a connecting end 113, and the annular part 120 is fixed to each connecting end 113 through the vertex of the grid structure at the corresponding position.

The inflow side bottom, 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 annular 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, in addition to the generally rectangular configuration shown in fig. 1a, 1 b.

Referring to fig. 1d, the connecting lug 114 has a neck 114b and a tip 114a, and the tip 114a is enlarged relative to the neck 114b, the portion of the connecting strip 117 connected to the neck 114b forms a shoulder 114d, and a groove 114c is formed between the shoulder 114d and the tip 114 a.

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.

Referring to fig. 1a and 1b, the connecting strip 117 is located closer to the top end of the binding post 112 than the hollowed-out window 116 is located at the connecting portion of the side edge of the U-shaped frame.

The connecting strip 117 is closer to the top end of the binding post 112 than the hollowed window 116, so as to ensure that the acting force applied by the connecting strip 117 to the U-shaped frame 111 is closer to the opening of the U-shaped frame, and the force required for expanding the U-shaped frame is smaller, thereby being more beneficial to the automatic expansion of the artificial valve bracket.

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 overall axial height (sum of L1 and L2) of the bracket is 22-28 mm, for example, the axial height of the bracket is 25+ -0.5 mm, 26.5+ -0.5 mm, etc. The shorter stent design can effectively avoid the risk that the valve blocks the coronary artery of the human body when the valve is implanted.

The diameter ratio of the bracket before and after the press holding is 1.3:1 to 1.6:1. correspondingly, the diameter ratio of the prosthetic valve before and after crimping is 1.3:1 to 1.6:1.

The stent is smaller than the interventional valve in pressing and holding, and the stent is mainly pressed and held by applying acting force to the supporting part, the annular part is deformed by adapting to the deformation of the supporting part, but the acting force is not applied to the annular part alone. Based on this, the above-mentioned diameter ratio before and after crimping refers to the diameter ratio of the stent/valve inflow portion before and after crimping.

Before holding, the whole cylindrical support, the diameter before holding is cylindrical bottom surface diameter, after holding, the frame strip of the U-shaped frame of supporting part is close to each other, and the diameter after holding is defined as the diameter of circumscribed circle after the frame strip tip of U-shaped is close to each other.

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, 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.

Referring to fig. 1a, 1b, the annular portion 120 has a plurality of end nodes at an inflow end (i.e., an end of the annular portion on the inflow side) and an outflow end (i.e., an end of the annular portion on the outflow side), and at least one end node of the outflow end of the annular portion is connected to the bottom of the U-shaped frame as a connecting portion. The cells between adjacent connection portions are not connected to the U-shaped frame. End nodes spanning 3-5 outflow ends between adjacent connection parts. The end nodes of the inflow end and the end nodes of the outflow end form at least one row of axially distributed cells.

In one embodiment, as shown in fig. 1a and 1b, the number of all the cells of the ring part is 9-24, 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, referring to FIG. 1b, the annular portion 120 has the same axial height in the flattened state. The axial heights of the cells are the same, that is, the sizes of the cells in the axial direction of the bracket are the same, and the positions of the cells in the axial direction of the bracket are also included in the same. The apexes of the cell outflow sides of the annular portions 120 are coplanar and the faces are perpendicular to the axial direction of the stent.

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 deformation between the side edges of the U-shaped frame 111 and the annular portion 120 is relatively independent.

Referring to fig. 1a and 1b, each cell of the ring portion is substantially diamond-shaped or hexagonal. Each cell of the annular part is of a complete diamond or hexagon, uniform supporting force is provided at each part in the circumferential direction, and the coating film can be better supported, so that the perivalvular leakage is prevented.

Referring to fig. 1a, each cell of the annular portion 120 in the circumferential direction is a complete cell. Referring to fig. 2a and 2b, at least one cell of the annular portion 120 in the circumferential direction is an incomplete cell, and the incomplete cell is a V-shaped frame bar.

At least a part of the annular portion 120 in the circumferential direction is a V-shaped frame strip 121. In fig. 2a and 2b, the connection bar is not shown, but a structure including the connection bar may be adopted, and the connection manner of the connection bar and the U-shaped frame is shown in fig. 1a and 1 b.

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 another embodiment, referring to fig. 2a, 2b, 2c, 2d, a stent, having opposite inflow and outflow sides, comprises:

The supporting portion 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. 2a is the blood flowing direction), the sides of two adjacent U-shaped frames 111 are adjacent to each other to form a binding post 112, and the sides of two adjacent U-shaped frames 111 meet to the top end of the binding post 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 the connection portions between the annular portion 120 and the support portion 110 are plural and correspond to the bottoms of the respective U-shaped frames 111 on the inflow side. At least one cell is a deformation release 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.

The remaining cells of the ring portion 120 are generally diamond-shaped or hexagonal, except for the deformation relief. The cells are diamond or hexagonal, and adjacent cells are connected through the vertexes of the 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.

Referring to fig. 2a, the number of deformation releasing lattices and the circumferential positions are in one-to-one correspondence with the coupling studs 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 some examples, referring to fig. 2a, the deformation releasing lattice is a V-shaped frame strip 121 with the opening of the V 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.

Although the V-shaped frame strip or the deformation releasing grid reduces the influence on the supporting part 110 when the annular part 120 deforms, the V-shaped frame strip also brings about the lack of support in the circumferential direction of the annular part, and the covering film is more likely to dent due to the lack of support at the corresponding part of the V-shaped frame strip, so that the hidden danger of paravalvular leakage exists.

Referring to fig. 3, each leaflet has a fixed edge connected to the U-shaped frame and a free edge that cooperates with the other leaflets She Xiangpei to change the opening degree of the blood flow channel, the fixed edge of the leaflet extends along the circumferential direction of the blood flow channel to form an ear protector 133, and a stress relief 136 is provided between the ear protector 133 and the fixed edge.

The stress release opening 136 is formed in a cutting mode, the stress release opening 136 is used for cutting off stress transmission between the ear protector and the fixed edge, the ear protector 33 and the fixed edge 132 are fixedly connected with the support in a sewing mode respectively, the ear protector and the fixed edge are respectively deformed in the process of being fixedly connected with the support to generate stress, and the stress release opening 136 is arranged to avoid mutual superposition of the stress and the stress, so that the shape of the valve leaflet is influenced.

Referring to fig. 3, a plurality of suture holes are formed in the fixing rim, the suture holes may be distributed along the fixing rim of the leaflet, and the suture passes through the suture holes to fix the fixing rim to the stent. One suture hole 134 is shown schematically in fig. 3.

The ear protector 133 has a positioning hole 135 adjacent to the fixing edge, and a line connecting the positioning hole 135 and a suture hole (e.g., the suture hole 134 shown in fig. 3) passes through the stress relief opening 136. The stitching holes 134 and the positioning holes 135 are respectively located at two sides of the stress release opening 136, so that the stress release opening can thoroughly block the stress transmission caused by stitching and fixing the fixing edge and the ear protector.

Referring to fig. 3, the tab 133 has a rectangular shape, and the positioning hole 135 is located in the middle of the rectangular width direction. The positioning hole 135 is located in the middle of the rectangular width direction, and the relative positions of the two earmuffs are preliminarily fixed through the positioning hole 135.

The annular sewing material band is close to the peripheral leakage prevention material band, the sewing material band and the peripheral leakage prevention material band are annular, but are not of a planar annular structure, but are slightly bent in space, the bending is in order to adapt to the bending of an internal valve annulus, the lowest point of the sewing material band and the highest point of the peripheral leakage prevention material band are tightly attached as much as possible, after the artificial valve is implanted in a body, the valve annulus is sewn and positioned, and the peripheral leakage prevention part is tightly attached to the sewing ring, so that the position and the shape are not easy to change, and a better peripheral leakage prevention effect can be achieved.

In one embodiment, as shown in FIG. 2e, 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. 2e, the suture ring 150 extends along the circumferential direction of the stent and has a wave structure in which a portion opposite to the inflow side is a wave trough, and a portion opposite to the outflow side is a wave crest, and the wave trough is abutted against the leakage preventing portion 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, as shown in FIG. 2e, the sewing ring 150 is on the inflow side of the U-shaped frame 111, leaving a space between 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 valve holder after being compressed, the deformation of the sewing ring 150 can not bring a larger deformation pressure to the leaflet 130.

In one embodiment, referring to fig. 2e, 2f, 2g, and 2h, the covering film 140 includes an outer covering film 142 and is wrapped on the outer side of the stent in the radial direction, and the peripheral leakage preventing portion 160 includes a peripheral leakage preventing material band 161 and a first portion of the outer covering film 142, where the first portion wraps the peripheral leakage preventing material band 161.

In one embodiment, referring to fig. 2e, 2f, 2g, and 2h, 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 whole, wherein the first part wraps the peripheral leakage preventing material belt 161, and the second part wraps the sewing material belt 151, so that the splicing of the outer cover 142 is reduced, the processing is convenient, and the material leakage is reduced.

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 some illustrations, referring to fig. 5, 2e, 2f, 2g, 2h, the cover includes an outer cover 142 on the outer surface of the stent and an inner cover 141 on the inner surface of the stent. The outflow side of the inner cover 141 interfaces to the fixation edge 132 of the leaflet 130, and both the inner cover 141 and the outer cover 142 are joined to the inflow side of the stent. Along the blood flow path, the outer covering film 142 is provided with a circumferential leakage prevention ring and a suture ring in sequence. The inner and outer cover films 142 cover the entire area of the U-shaped frame and grid structure. The inner and outer cover films 142 cover the U-shaped frame and mesh structure as much as possible except that it cannot cover it for process reasons, for example, the inner and outer cover films 142 avoid the hollowed-out window area to ensure sewing of the leaflets.

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.

The inner coating is made of biological material or composite material of PET and PU, and the outer coating is made of composite material of PET and PU. The PET and PU composite material structure is that the PU layers are attached to two sides of the PET layer.

The inner coating film is required to be as thin as possible, and meanwhile, enough strength is ensured, no damage occurs in the use process, and the outer coating film can be in a woven structure so as to promote the endothelialization process.

The inner coating can be biological material, such as bovine pericardium and porcine pericardium, or PET material or PET-PU composite material, and the outer coating can be PET-PU composite material, wherein PET-PU composite material is prepared by using PET material as substrate, and PU materials are compounded on two sides of PET 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. 2e, 2f, 2g, and 2h, the circumferential leakage preventing material tape 161 and the sewing material tape 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. 2h, the suture material band 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 band when wrapping the suture material band 151, so that the resulting suture ring 150 also has a wave structure consistent with the suture material band 151, the portion opposite to the inflow side is a trough, the portion opposite to the outflow side is a peak, and the trough is abutted against the leakage preventing portion 160.

The peripheral leakage prevention material belt 161 can be made of PU foaming materials, and the PU foaming materials have the characteristics of good elasticity and water impermeability, are favorable for being tightly attached to the valve annulus, and reduce peripheral leakage.

In one embodiment, as shown in fig. 2e, 2f, 2g, 2h, the leakage preventing material strip 161 comprises a substrate disposed about the periphery of the support and a water swellable material secured 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. 2e, 2f, 2g, 2h and 2i, 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, referring to fig. 2j, the peripheral leakage preventing portion 160 includes a peripheral leakage preventing material tape and a portion of the inner cover 141, and the peripheral leakage preventing material tape 161 is attached to the inner cover 141.

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

In one embodiment, as shown in fig. 2j, the circumferential leakage preventing material belt 161 is connected to the inflow side of the inner covering film 141, and is a plurality of blocks arranged at intervals along the circumferential direction of the support, the annular part has a grid structure, and the water absorbing expansion materials of the blocks respectively correspond to the hollow areas of the grid structure.

In one embodiment, referring to FIG. 2f, the sewing ring 150 carries threading indicia 170 thereon, the threading indicia 170 being offset from the binding post 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. 2g and 2h, in the loaded state, the sewing ring 150 is in a wave configuration extending circumferentially around 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, the sewing ring 150 carries a threading indicator 170, and in the loaded state, the threading indicator 170 is in the trough position.

Referring to fig. 2g, 2h, and 6 a-6 g, the present application discloses how the outer cover forms a sewing ring and/or a peripheral drain.

The outer coating 142 covers the radially outer side of the stent, and the outer coating 142 has an inner surface facing the inner side of the stent and an outer surface facing the outer side of the stent.

In some examples, a receiving cavity 143 for receiving the ring (sewing ring/peripheral drain) is located axially intermediate the outer cover 142.

As shown in fig. 6a, the outer covering film 142 has a cylindrical structure, and a first position a and a second position b are distributed on the outer covering film 142, and the first position a and the second position b are distributed along the axial direction of the bracket and surround the bracket for a circle; as shown in fig. 6b, the first position a and the second position b of the outer cover 142 are lifted so that the first position a and the second position b are close, and bulge outwards to form wrinkles; as shown in fig. 6c, when the first position a and the second position b are overlapped, a containing cavity 143 is enclosed, and the containing cavity 143 is generated by the wrinkles.

After the first position a and the second position b are overlapped, the first position a and the second position b are fixed in a sewing mode to form a containing cavity 143, and the containing cavity 143 surrounds the bracket for wrapping the annular piece.

During valve processing, the annular member is placed in a region positioned between the first position a and the second position b, and along the inner surface of the annular member, so that the first position a and the second position b are overlapped to form a containing cavity 143 for wrapping the annular member, the annular member is wrapped, and then the first position a and the second position b are fixed in a sewing mode, so that the annular member is tightly wrapped in the containing cavity 143.

In some examples, referring to fig. 6d,6e,6f,6g, a receiving cavity 143 for receiving a ring (sewing ring/circumferential drain) is located on the inflow side of the outer cover 142.

As shown in fig. 6d, the outer coating film 142 has a cylindrical structure, and along the axial direction thereof, a first position c and a second position d are distributed on the outer coating film 142, and the first position c and the second position d are distributed along the axial direction of the bracket and surround the bracket for a circle, wherein the second position d is located near the bottom edge of the coating film; as shown in fig. 6e, the outer cover 142 is folded inwardly or outwardly to form a receiving cavity 143 surrounding the ring. The outer covering film 142 is turned inwards or outwards, namely the outer covering film 142 turns towards the inner side of the bracket and the outer side of the bracket, and the second position d of the outer covering film 142 is turned (lifted) so that the second position d is close to the first position, and the bottom of the outer covering film gradually forms a containing cavity; as shown in fig. 6f, when the first position and the second position are overlapped, a receiving cavity 143 is defined, and the receiving cavity 143 surrounds the bracket for one circle. After the first position and the second position are overlapped, the first position and the second position are fixed in a sewing mode, so that a containing cavity 143 is formed, and the containing cavity 143 is used for wrapping the annular piece. In the valve processing process, before the first position and the second position are fixed by suturing, the annular piece can be placed in the accommodating cavity 143 first, so that the first position and the second position are overlapped, and then the first position and the second position are sutured, so that the accommodating cavity 143 is tightly wrapped by the annular piece.

In some illustrations, to conceal the suture, the outer cover 142 is rolled over, such that the inner surface of the cover is outside the cylinder and the outer surface is inside the cylinder, before the second position d of the outer cover is rolled over (lifted) up to the first position c; turning up (pulling up) the bottom edge (second position d) of the outer covering film 142 to a first position c, so that the bottom of the outer covering film gradually forms a containing cavity, placing the annular piece in the containing cavity, enabling the first position and the second position to coincide, and sewing the first position and the second position, so that the containing cavity 143 is tightly wrapped by the annular piece; the outer covering film is rolled again, so that the inner surface of the covering film is positioned on the cylindrical inner surface, and the outer surface of the covering film is positioned on the cylindrical outer surface, thereby hiding the suture.

Referring to the above-mentioned method for forming the receiving cavities, in some examples, the covering film is provided with a plurality of receiving cavities, and as shown in fig. 4, the covering film is provided with a sewing ring 150 and a peripheral leakage preventing portion 160, and the sewing ring 150 and the peripheral leakage preventing portion 160 are respectively formed by the receiving cavities located at the middle position of the covering film and the receiving cavities located at the bottom of the covering film. The ring-shaped member is a band of suture material 151 located in the central position of the outer cover 142, and the receiving chamber encloses the band of suture material as a suture ring to form a suture ring 150. The annular member in the accommodating cavity at the bottom of the outer covering film 142 is a circumferential leakage preventing material band 161, and the accommodating cavity wraps the circumferential leakage preventing material band 161 as a circumferential leakage preventing part to form a circumferential leakage preventing part 160.

The peripheral leakage preventing material belt is provided with a plurality of cuts, and the cuts are distributed along the circumferential direction of the peripheral leakage preventing material belt. The edge of the inflow side of the peripheral leakage prevention part is aligned with the edge of the inflow side of the stent.

Referring to fig. 4 and 6c, the receiving chamber 143 is located at the middle of the outer cover 142, the ring is a suture material band 151, and the receiving chamber 143 wraps the suture material band as a suture ring.

Referring to fig. 4 and 6g, the receiving chamber 143 is located on the inflow side of the outer cover 142, the ring member is a circumferential leakage preventing material band 161, and the receiving chamber 143 wraps the circumferential leakage preventing material band as a circumferential leakage preventing portion.

Referring to fig. 5, the inner and outer cover films 142 cover the entire area of the U-shaped frame and grid structure. The inner and outer cover films 142 cover the U-shaped frame and mesh structure as much as possible except that it cannot cover it for process reasons, for example, the inner and outer cover films 142 avoid the hollowed-out window area to ensure sewing of the leaflets.

The prosthetic valve further includes an inner cover covering a radially inner side of the stent. The axial end of the inner covering film is provided with a notch matched with the shape of the fixed edge of the valve leaflet.

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 the bracket to form the artificial valve.

In one embodiment, S100, the circumferential leakage preventing portion is formed by attaching a circumferential leakage preventing material tape 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 ribbon of suture material with a first portion of the stent radially outer cover.

In one embodiment, S200, a second preform is formed by wrapping a circumferential leakage prevention material tape with a second portion of the stent radially outer cover.

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.

In order to deliver the prosthetic valve into the body, the prosthetic valve is contracted to a small-size state by utilizing a valve holder and is conveyed to a target position, the valve holder is provided with a valve buckle matched with the prosthetic valve, a sleeve capable of moving along the axial direction is arranged outside the valve buckle, the sleeve is controlled by a control handle, and the working process of the valve holder is shown in fig. 7 a-7 g, and is specifically as follows:

referring to fig. 7a, the sleeve is moved toward the control handle to expose the valve clasper, with which the prosthetic valve is engaged;

referring to fig. 7b, the sleeve is moved away from the control handle to place the prosthetic valve in a compressed state;

referring to fig. 7c, the sleeve position is locked by the control handle;

referring to fig. 7d, the surgeon passes the suture through the native annulus and passes the suture through the sewing ring of the prosthetic valve in a compressed state, delivering the compressed prosthetic valve to the native annulus along the suture movement;

Referring to fig. 7e, the prosthetic valve is released by unlocking the position of the sleeve by the control handle and operating the sleeve to move toward the control handle and gradually switch from the loaded state to the released state;

Referring to fig. 7f, the prosthetic valve is completely disengaged from the valve catch and returned to its original size;

Referring to fig. 7g, the prosthetic valve is fully released and placed against the native valve annulus, the native valve annulus is sutured to the sewing ring of the prosthetic valve, and the holder is withdrawn.

As shown in fig. 8 to 27, an embodiment of the present application provides a holding device 20 for a prosthetic valve, where the holding device 20 can be positioned and connected with the prosthetic valve 30, and packaged, stored and transported together with the prosthetic valve 30, and when the prosthetic valve 30 is taken, the positioning connection with the prosthetic valve 30 is released according to the time, i.e. the two are separated.

The clamping device 20 comprises a support body 21 and a locking piece 22, wherein the support body 21 is provided with a positioning groove 2111 for receiving the artificial valve 30, and at least one part of the artificial valve 30 can be placed into the positioning groove 2111 to realize positioning connection of the two. The prosthetic valve 30 generally comprises a stent 32 and leaflets mounted in the stent 32, wherein one axial end of the stent 32 may be provided with a connecting lug 31 and is in positioning fit with a positioning groove 2111 through the connecting lug 31, and other parts of the stent 32 can be placed in the positioning groove 2111. The shape of the support body 21 is not strictly limited, and on one hand, the support body is connected with the artificial valve 30, and can be matched with an external packaging structure to position the artificial valve 30 in the packaging structure, so that the artificial valve 30 is prevented from shaking in the packaging structure.

The locking member 22 is engaged with the support body 21 in a movable manner not limited to the rotation engagement. The locking member 22 has a stop 221 that cooperates with a detent 2111 to limit the removal of the prosthetic valve and a handle 222 for urging the locking member 22 to rotate as a whole. Wherein the handle 222 is generally used for holding and exerting force by an operator, and in terms of rotation fit, during the rotation of the locking member relative to the supporting body, the blocking portion 221 can switch the position relationship with the opening of the positioning groove 2111 along with the rotation of the locking member 22, and has a first state and a second state opposite to each other, in the first state, at least a part of the prosthetic valve 30 is placed into the positioning groove 2111, and the blocking portion seals a part of the opening of the positioning groove 2111 to prevent the prosthetic valve 30 from being removed, i.e. at least interferes with the path of the prosthetic valve 30 from being removed from the positioning groove 2111; in the second state, the blocking portion opens the positioning groove 2111 to release the interference with the removal of the prosthetic valve 30, allowing the prosthetic valve to be removed from the positioning groove 2111. The blocking portion 221 can be switched between two states by rotation of the locking member 22 relative to the support body 21.

In one embodiment, the clamping device further includes an axial limiting member connected to the handle, the axial limiting member abuts against the top surface of the annular portion 211, and the blocking portion 221 is located at the bottom side of the support body and cooperates with the axial limiting member to limit the axial relative position of the locking member and the support body.

To prevent accidental rotation of the locking element 22, in one embodiment the clamping device further comprises a safety lock 23, which can act as a two-way lock, for example the safety lock 23 in fig. 10-11, acting between the handle 222 and the support 21, capable of limiting the rotation of the locking element 22 or at least the amplitude of rotation of the locking element 22, the safety lock 23 itself being either a separate component or part of the locking element 22 or the support 21. When the safety lock 23 releases the lock 22, the lock 22 is allowed to rotate until the prosthetic valve 30 can be removed from the detent 2111.

The embodiment shown in fig. 9 and 13 discloses a structure of the supporting body 21, which comprises an annular portion 211, and a plurality of positioning grooves 2111 are arranged on the annular portion 211 at intervals. With respect to the prosthetic valve 30, the ring portion 211 has opposite top and bottom sides, and the positioning slots 2111 open to the bottom side of the ring portion 211 to receive the prosthetic valve 30, with the prosthetic valve 30 in the fitted condition at the bottom side of the ring portion 211.

The locking member 22, which is adapted to the supporting body 21, further comprises a main body 223 rotatably mounted in a central region of the annular portion 211, and the shank 222 and the blocking portion 221 are fixed to the main body 223. The handle 222 is exposed to the top side of the ring portion 211 in the assembled state, facilitating handling; the blocking portion 221 extends to the bottom side of the ring portion 211 to be engaged with the positioning groove 2111. For example, as shown in fig. 9, the main body 223 is substantially columnar, has an outer peripheral surface fitted to an inner edge of the annular portion 211, and has a through hole 215 in a middle region of the annular portion 211 to which the main body 223 is attached, and an arrow indicates an assembling direction of the lock member 22 and the support body 21.

The mounting position of the safety lock 23 is shown in fig. 9 to 11, the handle 222 is provided with a mounting hole 2221 at the top side of the annular portion 211, the safety lock 23 is movably inserted into the mounting hole 2221, and the top side of the annular portion 211 is further provided with a limiting portion 214 for receiving the safety lock 23. Fig. 10 shows a sliding insertion process (arrow indicates a sliding direction) of the safety lock 23, in which the mounting hole 2221 of the handle 222 needs to be adjusted in time to align with one end of the safety lock 23, and after the safety lock 23 is in place, one end far from the handle 222 enters the limiting portion 214 and is engaged (fig. 11), thereby realizing circumferential position fixation of the safety lock 23.

In the engaged state, the blocking portion 221 blocks part of the positioning groove 2111, and the position of the safety lock 23 is fixed so that the locking member 22 and the supporting body 21 cannot rotate relatively (i.e., in the rotation-stopping state), and the three are assembled into a whole.

In the embodiment shown in fig. 18 and 19, the support 32 is provided with a coupling groove 33 adjacent to the connecting lug 31, and the axial height of the coupling groove 33 is approximately equal to the thickness of the blocking portion 221, and in the engaged state, the blocking portion 221 shields part of the positioning groove 2111 and is engaged with the coupling groove 33, and the two are adapted to further limit the circumferential rotation of the prosthetic valve 30, and simultaneously prevent the support 32 and the support body 21 from shaking in the height direction.

In the embodiment shown in fig. 9 to 11, the top side of the annular portion 211 forms an expansion portion 212 radially outwards, and the limiting portion 214 is a clamping groove arranged on the expansion portion 212, and one end of the safety lock 23 is adapted to the contour of the clamping groove and can be just clamped.

As shown in fig. 9, a stop strip 213 extending along the circumferential direction of the annular portion 211 is provided on the top side of the annular portion 211, and a part of the stop strip 213 is a break zone as a slot. In fig. 9, two barrier ribs 213 are provided with a break area therebetween as a clamping groove.

The embodiment shown in fig. 10 discloses a structure of a safety lock 23, which is a bolt, the bolt has a length direction L thereof, and two ends in the length direction extend out of a locking member 22 respectively and are mounted on the top surface of a supporting body 21, and can also be used as an axial limiting member to limit and maintain the axial position of the locking member 22.

One end of the latch has an upwardly protruding operating portion 231, and the operating portion 231 can limit the limit sliding position of the latch relative to the mounting hole 2221, for example, the latch is generally L-shaped, and a portion matching with the mounting hole 2221 is a sliding portion 232, which is beneficial to driving the safety lock 23 to slide smoothly. Further, the latch may be engaged with the slot through the end of the operating portion 231.

In addition, the height H1 of the operation part 231 should be greater than the height H2 of the barrier rib 213, improving convenience of operation. The width W1 of the operation portion 231 is substantially equal to the width W2 (in the circumferential direction) of the card slot, so that the operation portion 231 can be easily moved into and out of the card slot.

The clamping device 20 formed by the assembly of the safety lock 23, the locking element and the support body 21 can be adapted as a separate product to different prosthetic valves 30.

When it is desired to fit the prosthetic valve 30, the safety lock 23 has an unlocked state in which the disengagement catch allows the locking member 22 to rotate entirely. For example, in the embodiment shown in fig. 14, the blocking strip 213 has two opposite sides, wherein a side facing the handle 222 is an inner side, and when the end (the operation portion 231) of the safety lock 23, which is engaged with the clamping groove, slides out of the clamping groove to the inner side of the blocking strip 213, the safety lock 23 can rotate within the range, and during this process, the inner side of the blocking strip 213 can always limit the radial position of the safety lock 23, so as to play a role of preventing the release.

The handle 222 is rotatable relative to the support 21 in the unlocked state, and the blocking portion 221 partially blocks the positioning groove 2111 (the arrow in fig. 15 indicates the direction of rotation of the release) so that the positioning groove 2111 can receive or remove the prosthetic valve 30.

In the embodiment shown in fig. 18, the attachment ear 31 of the prosthetic valve 30 has a neck 311 and a tip 312, and the tip 312 is enlarged relative to the neck 311. During assembly, the tip 312 is inserted into the positioning groove 2111, and the handle 222 is rotated to close a part of the opening of the positioning groove 2111 by the stopper 221, so that the prosthetic valve 30 and the holding device 20 are in the fitted state.

Further, the end of the neck 311 away from the tip 312 has a shoulder 321, and the coupling groove 33 is formed between the shoulder 321 and the tip 312, so that the blocking portion 221 is blocked.

In order to effectively fix the position of the prosthetic valve 30, the positioning groove 2111 has a closing structure 216, the blocking portions 221 are plural and the radiation is distributed on the outer periphery of the main body 223, and the blocking portions 221 are sheet-shaped and slidably abutted against the bottom surface of the support body 21. The blocking portions 221 are specifically blades, which may have a fan shape, etc., for example, three blocking portions 221 in fig. 9 are equally spaced on the main body 223. In the fitted state of the prosthetic valve 30, the closing-in structure 216 restricts at least a portion of the tip 312, and the edge portion on one side of the leaflet can block the opening of the positioning groove 2111 along the circumferential direction of the annular portion 211.

As shown in fig. 26, the blocking portion 221 and the closing-in structure 216 are respectively located at two sides of the neck portion 311 along the circumferential direction of the annular portion 211, and both limit the tip 312.

In the embodiment shown in fig. 23, the bottom surface of the annular portion 211 is further provided with a limiting step 2112, and the blocking portion 221 has a first movement direction (fig. 20) along its own movement path with a closed positioning groove 2111, and an opposite second movement direction. The limit position of the blocking portion 221 in the second movement direction is blocked by the limit step 2112, and the height of the limit step 2112 is substantially consistent with the thickness of the blade, which helps to ensure the flatness of the bottom surface of the clamping device 20.

As shown in fig. 28-35, one embodiment of the present application provides a prosthetic valve packaging system comprising a plurality of packages sequentially nested from inside to outside, wherein each package may be flexible or rigid, and wherein at least one of the packages is preferably rigid for better product protection.

The innermost package in this embodiment is the inner case 40, which is usually made of plastic, and may be formed by plastic molding or injection molding. The inner case 40 includes a first case 41, a cover plate 42, and a first sealing film (not shown), wherein the first case 41 has opposite bottoms and tops, the tops have a first opening, the inside of the first case 41 is a cavity for accommodating a prosthetic valve, the inner wall of the first case 41 is annularly arranged with a first step 411 and a second step 412 at different heights, and the second step 412 is located higher than the first step 411. The first step 411 is used for placing a prosthetic valve, and it should be noted that the prosthetic valve is a product in a broad sense, and not only limited to the prosthetic valve body, but also can include a clamping device for fixing the prosthetic valve body, and before packaging, the clamping device is usually connected with the prosthetic valve body, and is conveniently placed in a packaging system as a whole (fig. 33); thus, the prosthetic valve may be indirectly mounted to the first step 411, for example, the edge of the clip may be mounted to the first step 411.

The cover plate 42 and the first box 41 are fastened to each other and located at the top of the cavity, and the fastening may be specifically that the edge of the cover plate 42 is movably mounted on the second step 412. On the one hand, the cover plate 42 can prevent the built-in artificial valve from directly contacting other external packages, so that mutual friction damage is avoided. On the other hand, the above-described snap-on manner facilitates opening of the cover 42 when the prosthetic valve is to be accessed. The first sealing film is used for sealing the first opening, can wrap the outer part of the cover plate 42, and integrally seals the inner box 40, thereby isolating the artificial valve from the external environment and protecting the artificial valve.

The packaging system in this embodiment further includes an outer box 50 that fits over the exterior of the inner box 40, with a secure fit between the two to maintain the stability of the internal prosthetic valve.

In the depth direction of the inner casing 40, the prosthetic valve is preferably suspended in such a way that a gap is left between the bottom side of the prosthetic valve and the inner bottom surface of the inner casing 40 to prevent scratching each other. For example, in fig. 34 and 35, the bottom surface of the first case 41 is provided with an annular sedimentation area 418, thereby forming a gap.

To avoid mismatching of directions at the time of assembly, the edge shape of the cover plate 42 is matched with the inner wall of the first case 41 at a predetermined angle in the circumferential direction, which may be unique, that is, the edge shape of the cover plate 42 is not matched with the contour of the inner wall of the first case 41 regardless of whether the cover plate 42 is rotated by 90 degrees or 180 degrees in the circumferential direction in the first case 41. Of course, the predetermined angle may be plural, for example, in fig. 30, the edge shape of the cover plate 42 is symmetrical on two sides, and the cover plate 32 can be matched with the inner wall of the first box 41 only at two angles, that is, the cover plate 42 can be circumferentially rotated 180 degrees and can also be matched with the inner wall of the first box 41.

In the embodiment shown in fig. 30 and 35, the second steps 412 may have multiple stages, and the cover plate 42 has multiple bends distributed at different heights and is adapted to the respective stages of the second steps 412. For example, in fig. 35, the second step 412 has two stages: the cover 42 has a plurality of continuous bonding surfaces formed by bending, wherein the two bonding surfaces are respectively overlapped on the second steps 412.

To prevent the accidental separation of the first case 41 and the cover plate 42, the inner wall of the first case 41 is further provided with a drop-preventing protrusion 413 above the second step 412. When assembled, the anti-drop protrusions 413 are pressed against the top surface of the cover plate 42. The anti-falling protrusions 413 may be provided in plurality and circumferentially distributed on the inner wall of the first case 41, for example, the inner wall of the first case 41 is provided with four anti-falling protrusions 413.

The outer case 50 may have a structure as shown in fig. 31 and 32, and includes a second case 51 and a second sealing film (not shown) that are engaged with each other. Wherein the top of the second box body 51 is provided with a second opening, and the inside of the second box body is a cavity for accommodating the inner box 40; the second sealing film is used for sealing the second opening.

The positioning of the outer and inner casings 50, 40 cooperate to limit the relative positions of the two, thereby providing better protection for the prosthetic valve. The positioning engagement includes a position restriction in the height direction and a position restriction in the circumferential direction.

In the embodiment shown in fig. 32, the inner wall of the second case 51 is provided with a third step 511, the top opening of the first case 41 is provided with a turned-out edge 414, and the turned-out edge 414 is movably overlapped on the third step 511, thereby restricting the positions of the inner case 40 and the outer case 50 in the height direction.

In addition, the edge of the first sealing membrane may be fixedly attached to the top surface of the cuff 414 to facilitate removal of the prosthetic valve. The first sealing film and the second sealing film are made of air-permeable and water-impermeable materials, such as a special paper.

In the embodiment shown in fig. 31, the edge shape of the outward flange 414 is matched with the inner wall of the second case 51 in a unique manner in the circumferential direction, i.e., the position restriction in the circumferential direction. Taking one side 4141 of the flange 414 as an example, the flange 414 does not match the contour of the inner wall of the second case 51 regardless of whether the first case 41 is rotated by 90 degrees or 180 degrees in the inner circumference of the second case 51.

Further, a plurality of limiting protrusions 417 are circumferentially and alternately distributed on the outer wall of the first box 41, and each limiting protrusion 417 abuts against the inner wall of the second box 51 to limit circumferential rotation of the first box 41 and the second box 51. For example, in one embodiment, the outer wall of the first case 41 is provided with 3 limit protrusions 417.

To facilitate removal of the prosthetic valve, the top surface of the second step 412 has a first relief area 416 that is countersunk and the edge of the cover plate 42 has a first recess 421 at a location corresponding to the location of the first relief area 416. For example, in fig. 32, the first avoidance area 416 is located at two opposite sides of the first box 41 along the width direction W3, and the structure is designed as an opposite end notch (shown by an arrow), so that the operator can take and put the first box with one hand.

In addition, the top surface of the third step 511 has a second relief area 512 that is sunk, and the edge of the flange 414 has a second recess 415 at a position corresponding to the position of the second relief area 512. In the embodiment shown in fig. 32, the second avoidance area 512 may have two positions, which are located on two opposite sides of the second box 51 along the width direction W4, and the structure is designed as an opposite end notch (shown by an arrow), so that the operator can take and put the second box with one hand.

In the embodiment shown in fig. 28, the package further includes a package 60 located outside of the outer box 50. The package 60 is typically a material that is both impermeable to air and water, such as an aluminum foil bag. The bag can be vacuum or flushed with gas for buffer protection, and the flushed gas can be air or inert gas such as nitrogen. The gas to be inflated may be inflated inwardly through each recess.

In the application, the artificial valve is a dry valve, namely, after drying treatment, a solution environment is not needed to be provided, the storage and transportation are more convenient, and in order to monitor or record the storage environment of the artificial valve, the packaging system can also comprise an induction element for acquiring temperature and/or humidity information and a corresponding display element.

The temperature and humidity information can be acquired by using a sensor based on a circuit or an induction element in a non-circuit form, the induction element can be arranged in an outer box or an inner box, the induction element and the display element can be integrated into a whole or communicated by a circuit or the like, the display element can be a display screen, a nixie tube or other elements with indication function, the display element can be fixedly attached to the packaging bag or positioned in the packaging bag, for example, the packaging bag is fixed to the outer box, and at least a transparent observation window corresponding to the position of the display element is arranged on the packaging bag.

The technical features of the above embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above 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 foregoing 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

1. A prosthetic valve having opposite inflow and outflow sides, comprising:

The inside blood flow channel that encloses of support, support includes:

2. The prosthetic valve of claim 1, wherein the ends of the connecting strip are fixedly connected to the sides of the U-shaped frame with the connection points adjacent the top ends of the commissure posts.

3. The prosthetic valve of claim 1, wherein the connecting strip has a frame strip strength that is less than a frame strip strength of a U-shaped frame.

4. The prosthetic valve of claim 1, wherein each U-shaped frame is provided with a corresponding connecting strip having a bend in the middle thereof, the bend protruding toward the bottom of the U-shaped frame.

5. The prosthetic valve of claim 1, wherein the stent is integrally cut from a tubular body, wherein the connecting strips are coplanar with the circumferential surface of the tubular body, or wherein the connecting strips are outwardly tilted relative to the circumferential surface of the tubular body.

6. The prosthetic valve of claim 1, wherein a bead strength of the U-shaped frame is greater than a bead strength of the loop.

7. The prosthetic valve of claim 1, wherein the apex of the commissure post widens circumferentially of the stent to form a connector lug for adaptation to a delivery system.

8. The prosthetic valve of claim 1, wherein one or more tie bars are disposed between the sides of adjacent U-shaped frames, the tie bars defining one or more hollowed-out windows at the location of the commissure posts.

9. The prosthetic valve of claim 1, wherein the lattice structure of the annulus is a circumferentially arranged cell, the annulus having a plurality of end nodes at the inflow and outflow ends; the end node of the outflow end of at least one annular portion is connected as a connecting portion to the bottom of the U-shaped frame.

10. The prosthetic valve of claim 9, wherein cells between adjacent connectors are not connected to a U-shaped frame.

11. The prosthetic valve of claim 10, wherein adjacent connections span between 3 and 5 outflow end nodes.

12. The prosthetic valve of claim 9, wherein the end nodes of the inflow end and the end nodes of the outflow end form at least one row of axially distributed cells.

13. The prosthetic valve of claim 12, wherein each cell of the annulus in the circumferential direction is either a complete cell or at least one cell is a non-complete cell.

14. The prosthetic valve of claim 13, wherein each complete cell of the annulus is substantially diamond-shaped or hexagonal.

15. The prosthetic valve of claim 1, wherein the stent has an axial height of 22-28 mm.

16. The prosthetic valve of claim 1, wherein the prosthetic valve has a diameter ratio of 1.3 before and after crimping: 1 to 1.6:1.

17. The prosthetic valve of claim 1, wherein the stent has an outer circumference surrounded by annular circumferentially-shaped leakage-preventing portions and sewing rings distributed in sequence along an outflow direction of a blood flow direction, the sewing rings extending circumferentially along the stent and having a wave structure with a trough at a position opposite an inflow side and a peak at a position opposite an outflow side.

18. The prosthetic valve of claim 17, wherein the peripheral leakage prevention portion and sewing ring are formed from the same covering film wrap.

19. The prosthetic valve of claim 17, wherein the trough and the peripheral leakage prevention portion of the sewing ring are proximate to each other.

20. The prosthetic valve of claim 1, wherein the fixation edge of the leaflet extends circumferentially of the blood flow passageway to form an ear guard, the ear guard having a stress relief opening disposed between the ear guard and the fixation edge.

21. A prosthetic valve, comprising:

22. A prosthetic valve clip, comprising:

23. A packaging system of a prosthetic valve, which is characterized by comprising the clamping device, the prosthetic valve and an inner box and an outer box which are sleeved in turn from inside to outside, wherein the inner box is matched with the outer box in a positioning way; the inner case includes:

A first sealing film closing the first opening.