CN219313512U - Packaging system for prosthetic valve - Google Patents

Abstract

The application discloses a packaging system of a prosthetic valve, which 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 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. The packaging system of the prosthetic valve has good storage performance, can ensure the stability and the safety of the prosthetic valve in the transportation process, and is convenient to take the prosthetic valve when in use.

Description

Packaging system for prosthetic valve

Technical Field

The application relates to the technical field of medical instruments, in particular to 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.

Prosthetic valves are classified into dry and wet valves according to the manner of preservation. Among them, dry films are generally preferably suspended in a packaging system during storage. Most of the existing packaging systems are poor in storage property, stability and safety of the artificial valve in the storage and transportation process are difficult to guarantee, and although the artificial valve is protected by the packaging systems through a complex structure, taking and operation are complicated.

Disclosure of Invention

In view of the prior art, the application provides a packaging system of a prosthetic valve, which can ensure the stability of the prosthetic valve in the storage and transportation process and is convenient to take out when in use.

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 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 packaging system of the prosthetic valve has good storage performance, can effectively protect the prosthetic valve in the transportation process, and is convenient to take the prosthetic valve when in use.

Drawings

FIG. 1 is a schematic diagram of a packaging system according to one embodiment;

FIG. 2 is a schematic view of a portion of a packaging system according to one embodiment;

FIG. 3 is an exploded view of FIG. 2;

FIG. 4 is a partially exploded view of FIG. 2;

FIG. 5 is a schematic structural diagram of a second case according to an embodiment;

FIG. 6 is a schematic view of a first case with a prosthetic valve built into it according to one embodiment;

FIG. 7 is a schematic view of the structure of the inner case according to an embodiment;

FIG. 8 is a partial cross-sectional view of FIG. 2;

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. 1-8, an embodiment of the present application provides a packaging system for a prosthetic valve, comprising a plurality of packages sequentially nested from inside to outside, wherein for each package, a flexible or rigid material may be used, and for better product protection, at least one of the packages is preferably a rigid material.

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. 6); 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. 7 and 8, the bottom surface of the first case 31 is provided with an annular sedimentation area 318, thereby forming a gap.

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. 3 and 8, 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. 8, 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. 4 and 5, and includes a second case 41 and a second sealing film (not shown) that are matched 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. 5, 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. 4, the edge shape of the outward flange 314 is matched with the inner wall of the second case 41 in a unique manner in the circumferential direction, i.e., the position restriction in the circumferential direction. 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. 7, 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. 5, the second avoidance area 412 may have two positions, which are located on two 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. 1, the package further includes a package 50 located outside of the sleeve 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 order to facilitate positioning of the prosthetic valve 20 and facilitate taking and placing, the prosthetic valve may be used with a holding device, for example, the holding device 10 of the prosthetic valve provided in the embodiment shown in fig. 3, where the holding device 10 may be positioned and connected with the prosthetic valve 20, and packaged, stored and transported together with the prosthetic valve 20, and when taking the prosthetic valve 20, the positioning connection with the prosthetic valve 20, that is, the two are released according to the timing.

The clamping device 10 in this embodiment includes: the support body 11 and the 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.

To prevent accidental rotation of the locking member 12, the clamping device 10 further comprises a safety lock 13, which may act as a two-way lock. The safety lock 13 itself may be a separate component or may be part of the locking member 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.

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 (15)

1. The packaging system of the artificial valve is characterized by comprising 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.

2. The prosthetic valve packaging system of claim 1, wherein the edge shape of the cover plate matches the inner wall of the first cartridge in a unique manner in the circumferential direction.

3. The packaging system of claim 1, wherein the second step is provided with multiple stages, and the cover plate has multiple bends distributed at different heights and respectively adapted to the respective second steps.

4. The prosthetic valve packaging system of claim 1, wherein the inner wall of the first cartridge is further provided with an anti-slip protrusion above the second step, the anti-slip protrusion limiting the top surface of the cover plate.

5. The prosthetic valve packaging system of claim 1, wherein the top surface of the second step has a first relief area that is submerged and the edge of the cover plate has a first recess at a location corresponding to the location of the first relief area.

6. The prosthetic valve packaging system of claim 5, wherein the first notch is two-way and is on opposite sides of the first cartridge in a width direction.

7. The prosthetic valve packaging system of claim 1, wherein the bottom surface of the first cartridge body is provided with an annular sedimentation zone to clear the bottom end of the prosthetic valve.

8. The prosthetic valve packaging system of claim 1, wherein the outer cartridge comprises a second cartridge body and a second sealing membrane that cooperate with each other, an inner wall of the second cartridge body being provided with a third step;

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.

9. The prosthetic valve packaging system of claim 8, wherein the rim shape of the cuff matches the inner wall of the second cartridge in a unique manner in the circumferential direction.

10. The prosthetic valve packaging system of claim 8, wherein the outer wall of the first cartridge body is circumferentially spaced apart with a plurality of stop tabs, each stop tab abutting an inner wall of the second cartridge body.

11. The prosthetic valve packaging system of claim 8, wherein the top surface of the third step has a countersunk second relief area and the rim of the cuff has a second recess at a location corresponding to the location of the second relief area.

12. The prosthetic valve packaging system of claim 11, wherein the second relief zone is two locations on opposite sides of the second cartridge in a width direction.

13. The prosthetic valve packaging system of claim 8, further comprising a package positioned 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.

14. The prosthetic valve packaging system of claim 1, wherein the prosthetic valve is a dry valve.

15. The prosthetic valve packaging system of claim 1, further comprising a sensing element to collect temperature and/or humidity information and a corresponding display element.

Images