CN219207511U - Clamping device and packaging system of artificial valve - Google Patents

Abstract

The application discloses clamping device and packaging system of prosthetic valve, clamping device includes: 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 release of the artificial valve 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 release of the artificial valve in the first state, and the blocking part opens the positioning groove to allow the release of the artificial valve from the positioning groove in the second state. This application is through constant head tank and prosthetic valve adaptation to the blocking portion switches with constant head tank open-ended positional relationship along with the holistic rotation of locking piece, makes things convenient for prosthetic valve to intervene and deviate from clamping device.

Description

Clamping device and packaging system of artificial valve

Technical Field

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

Background

Prosthetic valves are used primarily to replace diseased native valves, including stents, leaflets attached to the stents, and typically employ multi-layer packaging during storage and transportation to maintain an adapted storage environment and to protect against shock and contamination.

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 in a tight fit mode or a mode of arranging a release switch and the like, so that the operation is complicated, and in some cases, the retaining device and the artificial valve are separated due to some misoperation, so that the risk that the artificial valve is possibly damaged or polluted is caused.

Disclosure of Invention

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

A prosthetic valve clamping device in this application, 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 release of the artificial valve 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 release of the artificial valve in the first state, and the blocking part opens the positioning groove to allow the release of the artificial valve from the positioning groove in the second state.

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 part is fixedly connected to one end of the main body and is exposed to the top side of the annular part;

the blocking part is connected to the other end of the main body part, is fixed to the main body and extends to the bottom side 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 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 blocking part is a blade with radiation distributed on the main body, and the edge of one side of the blade rotates along the circumferential direction of the annular part to block the positioning groove.

Optionally, the edge rotation of one side of the blade blocks at least a portion of the detent.

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, in the fitted state, the blocking portion and the closing-in structure are respectively located 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.

Optionally, an axial limiting part is connected to the handle, and the axial limiting part abuts against the top surface of the annular part.

Optionally, the axial limiting piece is movably inserted with the handle.

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

The present application also 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 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 packaging system of the artificial valve comprises an inner box and an outer box which are sequentially sleeved 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 the clamping device of the artificial valve to be arranged on the inner wall of the first box body is annularly distributed, and a second step higher than the first step in position;

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 prosthetic valve is matched with the prosthetic valve through the locating slot, and the blocking part is switched with the position relation of the locating slot opening along with the whole rotation of the locking piece, so that the prosthetic valve is convenient to intervene and deviate from the clamping device.

Drawings

FIG. 1 is a schematic view of an assembly process of a clamping device according to an embodiment;

FIG. 2 is an assembled schematic view of a clamping device according to another embodiment;

FIG. 3 is a schematic view showing a structure of a clamping device assembled in one embodiment;

FIG. 4 is a schematic view of the structure of the clamping device after the safety lock is in place;

FIG. 5 is a schematic view of the structure of FIG. 4 at another angle;

FIG. 6 is an enlarged view of portion A of FIG. 5;

FIG. 7 is a schematic view of a safety lock sliding in one embodiment;

FIG. 8 is a diagram illustrating rotation of a security lock in one embodiment;

FIG. 9 is a schematic view of an assembly process of the clamping device and the prosthetic valve according to an embodiment;

FIG. 10 is an enlarged view of portion A of FIG. 9;

FIG. 11 is an enlarged view of portion B of FIG. 9;

FIG. 12 is a schematic view of an artificial valve intervention gripping device in an embodiment;

FIG. 13 is a diagram showing the rotation process of the safety lock in one embodiment;

FIG. 14 is a sliding process diagram of a security lock in one embodiment;

FIG. 15 is a view showing the clamping device and prosthetic valve in a first state according to one embodiment;

fig. 16 is an enlarged view of a portion a in fig. 15;

FIG. 17 is a schematic view of a connecting ear insertion positioning slot according to an embodiment;

FIG. 18 is a schematic view of an embodiment of a connecting ear entering a necked-in configuration;

FIG. 19 is a schematic view of a retaining portion and a crimping structure clamping attachment ear according to an embodiment;

FIG. 20 is a schematic view illustrating the cooperation between the blocking portion and the coupling groove according to an embodiment;

FIG. 21 is a schematic view of a packaging system according to an embodiment;

FIG. 22 is a schematic view of a portion of a packaging system according to one embodiment;

FIG. 23 is an exploded view of FIG. 22;

FIG. 24 is a partially exploded view of FIG. 22;

FIG. 25 is a schematic view of a second case according to an embodiment;

FIG. 26 is a schematic view of a first case incorporating a prosthetic valve according to one embodiment;

FIG. 27 is a schematic view showing the structure of an inner case according to an embodiment;

fig. 28 is a partial cross-sectional view of fig. 22.

Reference numerals in the drawings are described as follows:

10. a clamping device; 11. a support body; 111. an annular portion; 1111. a positioning groove; 1112. a limit step; 112. an expansion section; 113. a barrier strip; 114. a limit part; 115. a through hole; 116. a closing-in structure; 117. a side edge; 12. a locking member; 121. a blocking portion; 122. a handle; 1221. a mounting hole; 123. a main body; 13. a safety lock; 131. an operation unit; 132. a sliding part;

20. a prosthetic valve; 21. a connecting lug; 211. a neck; 212. an end head; 22. a bracket; 221. a shoulder; 23. a coupling groove;

30. an inner case; 31. a first case; 311. a first step; 312. a second step; 3121. a second step A; 3122. a second step B; 313. an anti-falling protrusion; 314. a flanging; 3141. a side edge; 315. a second notch; 316. a first avoidance zone; 317. a limit protrusion; 318. a settling zone; 32. a cover plate; 321. a first recess;

40. an outer case; 41. a second case; 411. a third step; 412. a second avoidance zone;

50. and (5) packaging bags.

Detailed Description

The following description of the technical solutions in the embodiments of the present application will be made clearly and completely with reference to the drawings in the embodiments of the present application, and it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present disclosure.

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 present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

As shown in fig. 1 to 20, an embodiment of the present application provides a holding device 10 for a prosthetic valve, where the holding device 10 can be positioned and connected with the prosthetic valve 20, and packaged, stored and transported together with the prosthetic valve 20, and when the prosthetic valve 20 is taken, the positioning connection with the prosthetic valve 20 is released according to the time, that is, the two are separated.

The clamping device 10 comprises a support body 11 and a locking piece 12, wherein the support body 11 is provided with a positioning groove 1111 for receiving the artificial valve 20, and at least one part of the artificial valve 20 can be placed into the positioning groove 1111 to realize positioning connection of the two. The prosthetic valve 20 generally includes a holder 22 and leaflets mounted in the holder 22, and an axial end of the holder 22 may have a connecting lug 21 and be in positioning engagement with the positioning slot 1111 via the connecting lug 21, although other portions of the holder 22 may be disposed in the positioning slot 1111. The shape of the support body 11 is not strictly limited, and on one hand, the support body is connected with the artificial valve 20, and can be matched with an external packaging structure to position the artificial valve 20 in the packaging structure, so that the artificial valve 20 is prevented from shaking in the packaging structure.

The locking member 12 is engaged with the supporting body 11 in a movable manner not limited to the rotation engagement. The locking member 12 has a stop 121 that cooperates with a detent 1111 to limit the removal of the prosthetic valve and a handle 122 for urging the locking member 12 to rotate as a whole. Wherein the handle 122 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 121 can switch the position relationship with the opening of the positioning slot 1111 along with the rotation of the locking member 12, 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 20 is placed into the positioning slot 1111, and the blocking portion closes a part of the opening of the positioning slot 111 to prevent the prosthetic valve 20 from being removed, i.e. at least interfere with the path of the prosthetic valve 20 from being removed from the positioning slot 1111; in the second state, the blocking portion opens the positioning groove 1111 to release the interference with the removal of the prosthetic valve 20, thereby allowing the prosthetic valve to be removed from the positioning groove 1111. The blocking portion 121 can be switched between two states by rotation of the locking member 12 relative to the support body 11.

In one embodiment, the clamping device further comprises an axial limiting member connected to the handle, the axial limiting member abuts against the top surface of the annular portion 111, and the blocking portion 121 is located at the bottom side of the support and cooperates with the axial limiting member to limit the axial relative position of the locking member and the support.

To prevent accidental rotation of the locking element 12, in one embodiment the clamping device further comprises a safety lock 13, which can act as a two-way lock, for example the safety lock 13 in fig. 3-5, acting between the handle 122 and the support 11, capable of limiting the rotation of the locking element 12 or at least the amplitude of the rotation of the locking element 12, the safety lock 13 itself being either a separate component or being part of the locking element 12 or the support 11. When the safety lock 13 releases the restriction of the locking member 12, the locking member 12 is allowed to rotate until the prosthetic valve 20 can come out of the positioning groove 1111.

The embodiment shown in fig. 2 and 6 discloses a structure of the supporting body 11, which comprises an annular portion 111, and a plurality of positioning grooves 1111 are arranged at intervals on the annular portion 111. With respect to the prosthetic valve 20, the annular portion 111 has opposite top and bottom sides, and the detent 1111 opens to the bottom side of the annular portion 111 to receive the prosthetic valve 20, with the prosthetic valve 20 being on the bottom side of the annular portion 111 in the mated state.

The locking member 12, which is adapted to the supporting body 11, further comprises a body 123 rotatably mounted in a central region of the annular portion 111, and the shank portion 122 and the blocking portion 121 are fixed to the body 123. The handle 122 is exposed to the top side of the annular portion 111 in the assembled state, facilitating handling; the blocking portion 121 extends to the bottom side of the annular portion 111 to be engaged with the positioning groove 1111. For example, as shown in fig. 2, the main body 123 has a substantially columnar shape and has an outer peripheral surface fitted to the inner edge of the annular portion 111, and the central region of the annular portion 111 has a through hole 115 for attaching the main body 123, and an arrow indicates the direction in which the lock 12 is assembled with the support body 11.

The mounting position of the safety lock 13 is shown in fig. 2 to 4, the handle 122 is provided with a mounting hole 1221 at the top side of the annular part 111, the safety lock 13 is movably inserted into the mounting hole 1221, and the top side of the annular part 111 is further provided with a limiting part 114 for receiving the safety lock 13. Fig. 3 shows a sliding insertion process (arrow indicates a sliding direction) of the safety lock 13, in which the mounting hole 1221 of the handle 122 needs to be adjusted in time to align with one end of the safety lock 13, and after the safety lock 13 is in place, one end far from the handle 122 enters the limiting part 114 and is engaged (fig. 4), so that the circumferential position of the safety lock 13 is fixed.

In the engaged state, the blocking portion 121 blocks part of the positioning groove 1111, and the position of the safety lock 13 is fixed so that the locking member 12 and the supporting body 11 cannot rotate relatively (i.e. in the rotation-stopping state), and the three are assembled into a whole.

In the embodiment shown in fig. 11 and 20, the support 22 is provided with a coupling groove 23 adjacent to the connecting lug 21, and the axial height of the coupling groove 23 is approximately equal to the thickness of the blocking portion 121, and in the engaged state, the blocking portion 121 blocks part of the positioning groove 1111 and is engaged with the coupling groove 23, and the two are adapted to further limit the circumferential rotation of the prosthetic valve 20, and simultaneously prevent the support 22 and the support body 11 from shaking in the height direction.

In the embodiment shown in fig. 2 to 4, the top side of the annular portion 111 forms an expansion portion 112 radially outwards, and the limiting portion 114 is a clamping groove arranged on the expansion portion 112, and one end of the safety lock 13 is adapted to the contour of the clamping groove and can be just clamped.

As shown in fig. 2, a stop strip 113 extending along the circumferential direction of the annular portion 111 is provided on the top side of the annular portion 111, and a part of the stop strip 113 is a break zone as a slot. In fig. 2, two barrier ribs 113 are provided with a break area therebetween as a clamping groove.

The embodiment shown in fig. 3 discloses a safety lock 13, which is a latch, wherein the latch has a length direction L, and two ends in the length direction extend out of the locking member 12 respectively and are lapped on the top surface of the supporting body 11, and can also be used as an axial limiting member to maintain the axial position of the locking member 12.

One end of the bolt has an operation portion 131 protruding upward, and the operation portion 131 can limit the limit sliding position of the bolt relative to the mounting hole 1221, for example, the bolt is substantially L-shaped, and a portion matching with the mounting hole 1221 is the sliding portion 132, which is beneficial to driving the safety lock 13 to slide smoothly. Further, the latch may be engaged with the slot through the end of the operating portion 131.

In addition, the height H1 of the operating part 131 should be greater than the height H2 of the barrier rib 113, improving convenience of operation. The width W1 of the operation portion 131 is substantially equal to the width W2 (in the circumferential direction) of the card slot, so that the operation portion 131 can easily enter and exit the card slot.

The clamping device 10 formed by the assembly of the safety lock 13, the locking element and the support body 11 can be adapted as a separate product to different prosthetic valves 20.

When it is desired to fit the prosthetic valve 20, the safety lock 13 has an unlocked state in which the disengagement catch allows the locking member 12 to rotate entirely. For example, in the embodiment shown in fig. 7, the blocking strip 113 has two opposite sides, wherein a side facing the handle 122 is an inner side, and when the end (the operation portion 131) of the safety lock 13, which is matched with the clamping groove, slides out of the clamping groove to the inner side of the blocking strip 113, the safety lock 13 is in an unlocked state, and the inner side of the blocking strip 113 can always limit the radial position of the safety lock 13 to play a role of preventing disengagement.

The handle 122 is rotatable relative to the support 11 in the unlocked state, and the blocking portion 121 partially blocks the positioning groove 1111 (the arrow in fig. 8 indicates the direction of rotation of the release) so that the positioning groove 1111 can receive or remove the prosthetic valve 20.

In the embodiment shown in fig. 11, the attachment ear 21 of the prosthetic valve 20 has a neck 211 and a tip 212, and the tip 212 is enlarged relative to the neck 211. The fitting end 212 is inserted into the positioning groove 1111, and the blocking portion 121 closes a part of the opening of the positioning groove 1111 by rotating the handle 122, and the prosthetic valve 20 and the holding device 10 are in the fitted state.

Further, the end of the neck 211 away from the tip 212 has a shoulder 221, and the coupling groove 23 is formed between the shoulder 221 and the tip 212, so that the blocking portion 121 is blocked.

In order to effectively fix the position of the prosthetic valve 20, the positioning groove 1111 has a closing structure 116, a plurality of blocking portions 121 are distributed on the outer periphery of the main body 123, and the blocking portions 121 are sheet-shaped and slidably abutted against the bottom surface of the support body 11. The blocking portions 121 are specifically blades, which may have a fan shape, etc., for example, three blocking portions 121 in fig. 2 are equally spaced on the main body 123. In the fitted state of the prosthetic valve 20, the constriction 116 limits at least a portion of the tip 212, and the edge portion on one side of the leaflet can block the opening of the positioning slot 1111 along the circumferential direction of the annular portion 111.

As shown in fig. 19, the blocking portion 121 and the closing-in structure 116 are respectively located at two sides of the neck portion 211 along the circumferential direction of the annular portion 111, and both limit the end 212.

In the embodiment shown in fig. 16, the bottom surface of the annular portion 111 is further provided with a limit step 1112, and the blocking portion 121 has a first movement direction (fig. 13) along its own movement path with a closed positioning groove 1111, and an opposite second movement direction. The limit position of the blocking portion 121 in the second movement direction is blocked by the limiting step 1112, and the height of the limiting step 1112 is substantially identical to the thickness of the blade, which helps to ensure the flatness of the bottom surface of the clamping device 10.

As shown in fig. 21-28, an embodiment of the present application provides a prosthetic valve packaging system comprising a plurality of packages nested one inside the other, 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 box 30, which is usually made of plastic, and may be formed by plastic molding or injection molding. The inner case 30 includes a first case 31, a cover plate 32, and a first sealing film (not shown), wherein the first case 31 has opposite bottoms and tops, the tops have first openings, the inside of the first case 31 is a cavity for accommodating a prosthetic valve, the inner wall of the first case 31 is annularly arranged with a first step 311 and a second step 312 at different heights, and the second step 312 is located higher than the first step 311. The first step 311 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. 26); thus, the prosthetic valve may be indirectly mounted to the first step 311, for example, the edge of the clip may be mounted to the first step 311.

The cover plate 32 and the first box 31 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 32 is movably mounted on the second step 312. On the one hand, the cover plate 32 can prevent the built-in artificial valve from directly contacting other external packages, so that mutual friction damage is avoided. On the other hand, when the prosthetic valve is to be taken, the above-described manner of movable engagement facilitates opening of the cover plate 32. The first sealing film is used for sealing the first opening, can wrap the outer part of the cover plate 32, and integrally seals the inner box 30, so that the artificial valve is isolated from the external environment, and the protection effect is achieved.

The packaging system in this embodiment further includes an outer casing 40 that fits over the outer portion of the inner casing 30, with a secure fit between the two to maintain the stability of the internal prosthetic valve.

In the depth direction of the inner casing 30, it is preferable that the prosthetic valve is 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 30 to prevent the prosthetic valve from scratching each other. For example, in fig. 27 and 28, an annular sedimentation area 318 is provided on the bottom surface of the first case 31, so that a gap is formed.

To avoid mismatching of directions during assembly, the edge shape of the cover plate 32 is matched with the inner wall of the first case 31 at a predetermined angle in the circumferential direction, which may be unique, that is, the edge shape of the cover plate 32 is not matched with the contour of the inner wall of the first case 31 regardless of whether the cover plate 32 is rotated by 90 degrees or 180 degrees in the circumferential direction in the first case 31. Of course, the predetermined angle may be plural, for example, in fig. 3, the edge shape of the cover plate 32 is symmetrical on two sides, and the cover plate 32 can be matched with the inner wall of the first box 31 only at two angles, that is, the cover plate 32 can be circumferentially rotated 180 degrees to be matched with the inner wall of the first box 31.

In the embodiment shown in fig. 23 and 28, the second step 312 may have multiple stages, and the cover plate 32 has multiple bends distributed at different heights, and is adapted to each stage of the second step 312. For example, in fig. 28, the second step 312 has two stages: the cover plate 32 has a plurality of continuous bonding surfaces formed by bending, wherein the two bonding surfaces are respectively overlapped on the second steps 312 of each stage, and the second steps a3121 and B3122.

To prevent the accidental separation of the first case 31 and the cover plate 32, the inner wall of the first case 31 is further provided with a drop-preventing protrusion 313 above the second step 312. When assembled, the anti-falling protrusion 313 is pressed against the top surface of the cover plate 32. The anti-falling protrusions 313 may be provided in plurality and the inner wall of the first case 31 is circumferentially distributed, for example, the inner wall of the first case 31 is provided with four anti-falling protrusions 313.

The outer case 40 may have a structure as shown in fig. 24 and 25, and includes a second case 41 and a second sealing film (not shown) that are engaged with each other. Wherein the top of the second box 41 has a second opening, and the interior is a cavity for accommodating the inner box 30; the second sealing film is used for sealing the second opening.

The positioning of the outer and inner casings 40, 30 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. 25, the inner wall of the second case 41 is provided with a third step 411, the top opening of the first case 31 is provided with an outward flange 314, and the outward flange 314 is movably overlapped on the third step 411, thereby restricting the positions of the inner case 30 and the outer case 40 in the height direction.

In addition, the edge of the first sealing membrane may be fixedly attached to the top surface of the cuff 314 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. 24, the edge shape of the outward flange 314 is matched with the inner wall of the second case 41 in the circumferential direction in a unique manner, that is, in the circumferential direction, the position restriction. Taking one side 3141 of the flange 314 as an example, the flange 314 does not match the contour of the inner wall of the second case 41, regardless of whether the first case 31 is rotated by 90 degrees or 180 degrees in the inner circumference of the second case 41.

Further, a plurality of limiting protrusions 317 are circumferentially spaced apart from the outer wall of the first box 31, and each limiting protrusion 317 abuts against the inner wall of the second box 41 to limit circumferential rotation of the first box 31 and the second box 41. For example, in one embodiment, the outer wall of the first box 31 is provided with 3 limiting protrusions 317.

To facilitate removal of the prosthetic valve, the top surface of the second step 312 has a first relief area 316 that is countersunk and the edge of the cover plate 32 has a first notch 321 at a location corresponding to the location of the first relief area 316. For example, in fig. 27, the first avoidance area 316 has two positions, and is located on two opposite sides of the first box 31 along the width direction W3, and the structure is designed as an opposite end notch (shown by an arrow), so that the first avoidance area is convenient for an operator to take and place with one hand.

In addition, the top surface of the third step 411 has a second relief area 412 that is depressed, and the edge of the flange 314 has a second recess 315 at a location corresponding to the location of the second relief area 412. In the embodiment shown in fig. 25, the second avoidance area 412 may have two positions, which are located on opposite sides of the second box 41 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. 21, the packaging system further includes a package 50 located outside of the outer box 40. The package 50 is typically a gas-impermeable and water-impermeable material, 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 this application, the prosthetic valve is the dry valve, promptly after the desiccation is handled, need not to provide the solution environment, the warehousing and transportation of being convenient for more, in order to monitor or record the preserving environment of prosthetic valve, packaging system can also include the sensing element and the corresponding display element of gathering temperature and/or humidity information.

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-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

The above examples merely represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the utility model. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application. Accordingly, the scope of protection of the present application shall be subject to the appended claims.

Claims (14)

1. A prosthetic valve clip, 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 release of the artificial valve 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 release of the artificial valve in the first state, and the blocking part opens the positioning groove to allow the release of the artificial valve from the positioning groove in the second state.

2. The prosthetic valve clamping device of claim 1, wherein the support body comprises an annular portion, the plurality of positioning slots being spaced apart from the annular portion, the annular portion having opposite top and bottom sides, the positioning slots being open to the annular portion bottom side, the prosthetic valve being in the annular portion bottom side in the mated condition.

3. The prosthetic valve clamping device of claim 2, wherein the locking element comprises:

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

the handle is connected to one end of the main body and is exposed to the top side of the annular part;

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

4. The prosthetic valve clamping device of claim 1, wherein the prosthetic valve comprises a stent and leaflets mounted in the stent, wherein one axial end of the stent is provided with a connecting lug, and wherein the stent is provided with a coupling groove for engaging the blocking portion at a position adjacent to the connecting lug.

5. The device of claim 4, wherein the connector lug has a neck and an end that is enlarged relative to the neck, the end being in a corresponding detent in the fitted state of the valve, the blocking portion closing a portion of the opening of the detent;

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.

6. A prosthetic valve clamping device as claimed in claim 3, wherein the blocking portion is a vane having radiation distributed on the body, the edge rotation of one side of the vane blocking the detent along the circumference of the annular portion.

7. The prosthetic valve clamping device of claim 6, wherein rotation of an edge of one side of the leaflet blocks at least a portion of the detent.

8. The prosthetic valve clamping device of claim 5, wherein the detent has a constriction, the prosthetic valve in the fitted state, the constriction constricting at least a portion of the tip.

9. The prosthetic valve clamping device of claim 8, wherein the stop and the constriction are on opposite sides of the neck along the circumference of the annular portion, respectively, and simultaneously limit the tip in the fitted state of the prosthetic valve.

10. The device according to claim 2, wherein the bottom surface of the annular portion is provided with a limit step, and the blocking portion has a first movement direction closing the positioning groove and an opposite second movement direction along its own movement path; and the limit position in the second movement direction is blocked by the limit step.

11. The prosthetic valve clamping device of claim 2, wherein an axial stop is attached to the stem portion, the axial stop abutting a top surface of the annular portion.

12. The prosthetic valve clamping device of claim 11, wherein the axial stop is removably insertable between the stem portion.

13. The prosthetic valve clamping device of claim 6, wherein the leaflet abuts a bottom surface of the annular portion.

14. A packaging system for a prosthetic valve, comprising a clamping device for a prosthetic valve according to any one of claims 1-13, characterized by comprising an inner case and an outer case, which are sequentially nested from inside to outside, said inner case and outer case being in a positioning fit; the inner case includes:

a first box body, wherein the first box body is provided with a bottom and a top which are opposite, the top is provided with a first opening, the interior of the first box body is a cavity for accommodating a prosthetic valve, a first step for the clamping device of the prosthetic valve in any one of claims 1-13 to be lapped on is distributed on the inner wall of the first box body, and a second step which is higher than the first step;

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.

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