WO2024145905A1

WO2024145905A1 - Integrated vial cap having covered exterior and integrally sealed interior, and vial

Info

Publication number: WO2024145905A1
Application number: PCT/CN2023/070923
Authority: WO
Inventors: 刘师宏; 刘超
Original assignee: 湖南千山制药机械股份有限公司
Priority date: 2023-01-05
Filing date: 2023-01-06
Publication date: 2024-07-11
Also published as: CN115892726A

Abstract

Disclosed in the present invention is an integrated vial cap having a covered exterior and an integrally sealed interior. The vial cap comprises a circular body, a sealing ring and a rubber plug, wherein a first side end face of the circular body is provided with a first annular wall and a second annular wall; a second side end face of the circular body is provided with a third annular wall; the first annular wall, the second annular wall and the third annular wall are coaxially arranged; the inner diameter of the first annular wall is greater than the outer diameter of the second annular wall; an inner wall of the first annular wall, the first side end face of the circular body, and an outer wall of the second annular wall enclose a first injection molding cavity in which the sealing ring is formed by means of injection molding and seals an opening of a vial in an inserted manner; an inner wall of the second annular wall and the first side end face of the circular body enclose a connecting cavity; an inner wall of the third annular wall and the second side end face of the circular body enclose a second injection molding cavity in which the rubber plug is formed by means of injection molding; a puncture portion separating the connecting cavity from the second injection molding cavity is provided in the middle of the circular body; and a sealing film is welded to an upper end face of the third annular wall. In addition, further disclosed in the present invention is a vial.

Description

Integrally coated outer film and integrally sealed vial cap and vial

Technical Field

The present invention relates to the technical field of vials, and in particular to a vial cap having an integral outer film and an inner integral sealed vial. In addition, the present invention also relates to a vial comprising the vial cap having an integral outer film and an inner integral sealed vial.

Background technique

A vial is an injection bottle sealed with a rubber stopper and a combination cap. It is generally used for the packaging of vaccines, powder injections, lyophilized drugs and other medicines. The vial is usually injected with a needle, so the rubber stopper is needed to hold the needle tightly and seal it when the needle punctures the vial. Both the internal and external seals of the rubber stopper in the combination cap are very critical. On the one hand, the rubber stopper should be prevented from contacting the drug to affect the quality of the drug. On the other hand, the rubber stopper should be prevented from contacting the external environment to prevent pathogens from adhering to the rubber stopper and being brought into the drug when the needle punctures the vial.

However, when the aluminum-plastic composite cap is used to seal the bottle mouth of the syringe bottle, the aluminum-plastic composite cap is mainly rolled onto the bottle mouth with a piercing knife, but the friction between the piercing knife and the aluminum-plastic composite cap will cause aluminum powder to be generated, thereby polluting the environment. In order to solve this problem, a composite cap structure is used to seal the bottle mouth of the syringe bottle, including a main cap and a sealing cap. The outer peripheral wall formed by the main cap extending downward and the annular wall formed by the sealing cap extending downward form a sealing cavity, and a sealing ring is arranged in the sealing cavity to be pressed and plugged with the bottle mouth of the syringe bottle through the sealing cavity to achieve sealing. However, when performing the external seal to prevent the rubber plug from contacting the external environment, the main seal is mainly sealed by a breakable structure. This makes the external seal of the rubber plug relatively loose. When the breakable structure is broken or pulled off to expose the rubber plug, it is necessary to The rubber stopper must be sterilized and disinfected again before the injection needle can be used to puncture the rubber stopper to inject the drug. The operation process is very cumbersome and the drug injection efficiency is low. For example, Chinese utility model patent CN2017882947U discloses a vial packaging with a composite cover, in which the outer seal of the rubber stopper is achieved by snap-fitting an easy-folding cap. Correspondingly, there is a problem of insufficient sealing. In addition, drug injection is mainly manually operated by medical staff, and there is interference from human factors. Once sterilization and disinfection are not in place, it is easy to bring additional safety risks to the patient. In addition, since a rubber stopper fixing structure needs to be set, the structure of the vial cover is relatively complex and difficult to manufacture. At the same time, the isolation membrane needs to be welded to the bottom wall inside the composite cover by a welding process, which further increases the difficulty of manufacturing and processing.

Summary of the invention

The present invention provides a vial cap and a vial with an integral outer film and an inner integral seal, so as to solve the technical problems that the existing vial cap generates aluminum powder chips to pollute the working environment when installing, or the vial cap has a complex structure and is difficult to manufacture, and the outer seal of the rubber plug is not tight enough, so that additional sterilization and disinfection treatment is still required during use, which is cumbersome to operate.

According to one aspect of the present invention, there is provided an integral outer film inner integrated sealed syringe bottle cap, comprising a circular body, a sealing ring and a rubber plug, a first side end surface of the circular body is provided with a first ring wall and a second ring wall, a second side end surface of the circular body is provided with a third ring wall, the first ring wall, the second ring wall and the third ring wall are coaxially arranged, the inner diameter of the first ring wall is greater than the outer diameter of the second ring wall, the inner wall of the first ring wall, the first side end surface of the circular body, and the outer wall of the second ring wall are combined to form a first injection molding cavity for injection molding of the sealing ring and plugged and sealed with the bottle mouth of the syringe bottle, the inner wall of the second ring wall and the first side end surface of the circular body are combined to form a connecting cavity for connecting the inner cavity of the syringe bottle, the inner wall of the third ring wall and the second side end surface of the circular body are combined to form a second injection molding cavity for injection molding of the rubber plug, a puncture portion separating the connecting cavity and the second injection molding cavity is provided in the middle part of the circular body, and a sealing film is welded and attached to the upper end surface of the third ring wall to seal the upper end opening of the second injection molding cavity.

As a further improvement of the above technical solution:

Furthermore, the thickness of the puncture portion is 0.3 mm-0.5 mm.

Furthermore, the lower end portion of the first annular wall is provided with an arc chamfer or a conical chamfer for plug-in guidance.

Furthermore, a puncture groove for injection needle puncture is concavely provided in the middle of the upper end surface of the rubber plug.

Furthermore, the sealing film is provided with an easy-tear edge extending radially outward, and the easy-tear edge is provided with a concave-convex structure for increasing friction.

Furthermore, a clamping protrusion is radially protruded inwardly on the inner wall surface of the first annular wall and is used to clamp with the bottle mouth of the syringe bottle.

Furthermore, the second annular wall is provided with a volatilization groove for connecting the first sealing cavity and the connecting cavity, and the inner wall of the first annular wall is provided with a limiting protrusion for squeezing and cooperating with the bottle mouth of the syringe bottle to limit the bottle mouth of the syringe bottle from continuing to move upward within a preset force, and the vertical height of the volatilization groove is lower than the vertical height of the sealing ring.

Furthermore, the inner diameter of the second annular wall is greater than the outer diameter of the third annular wall.

Furthermore, the inner diameter of the third annular wall is greater than the outer diameter of the second annular wall.

According to another aspect of the present invention, there is also provided a vial, which comprises the above-mentioned integral outer film inner integrated sealed vial cap.

The present invention has the following beneficial effects:

The integral outer film inner integrated sealed syringe bottle cap of the present invention has a circular main body, a first ring wall, a second ring wall and a third ring which are molded by injection molding at one time. The sealing ring is molded by injection molding in the first injection molding cavity by injection molding to be plugged and sealed with the bottle mouth of the syringe bottle to achieve the sealing of the syringe bottle. The rubber plug is molded by injection molding in the second injection molding cavity by injection molding. The base of the rubber plug is bonded and compatible with the base of the third ring wall. The connection is reliable and has high stability. The connecting cavity and the second injection molding cavity are separated by a puncture part to achieve the internal sealing of the rubber plug. The puncture part is molded together in the injection molding process of the circular main body. The structure is compact and the manufacturing and processing difficulty is low. The puncture part is welded on the third ring wall by welding. A sealing film is welded on the end face to seal the upper opening of the second injection cavity to achieve surface-to-surface sealing, prevent the rubber plug from contacting the external environment, and ensure tight and reliable sealing. This solution achieves plug-in sealing through the first injection cavity, and no aluminum powder is generated during installation. The rubber plug is formed through a double-material injection molding process, and the rubber plug no longer needs to be fixed by a fixed structure. The internal structure of the syringe bottle cap is simple, and the internal sealing of the rubber plug is achieved through the puncture portion, and the external sealing of the rubber plug is achieved through the sealing film. The sealing of the rubber plug is tight and reliable. Compared with the existing technology, the manufacturing and processing difficulty of the syringe bottle cap is greatly reduced, and no additional disinfection is required during use. It is convenient for medical staff to use, has strong practicality, and is suitable for wide promotion and application.

In addition to the above-described objects, features and advantages, the present invention has other objects, features and advantages. The present invention will be further described in detail with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings constituting a part of this application are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the drawings:

FIG1 is a schematic diagram of the three-dimensional structure of a sealed penicillin bottle cap with an integral outer film and an inner integral body according to a preferred embodiment of the present invention;

FIG2 is a cross-sectional view of the integral outer film inner integrated sealed penicillin bottle cap shown in FIG1;

FIG3 is a cross-sectional view of the integral outer film inner integrated sealed penicillin bottle cap shown in FIG1;

FIG. 4 is a cross-sectional view of the integral outer film-coated, inner-integrated sealed penicillin bottle cap shown in FIG. 1 .

illustration:

100, circular body; 110, puncture portion; 200, sealing ring; 300, rubber plug; 400, first ring wall; 410, snap-fit protrusion; 420, limiting protrusion; 500, second ring wall; 510, volatilization groove; 600, third ring wall; 700, sealing film.

Detailed ways

The embodiments of the present invention are described in detail below with reference to the accompanying drawings. However, the present invention can be implemented in many different ways as defined and covered below.

Figure 1 is a schematic diagram of the three-dimensional structure of an integral outer film-integrated sealed vial cap according to a preferred embodiment of the present invention; Figure 2 is a cross-sectional view of the integral outer film-integrated sealed vial cap shown in Figure 1; Figure 3 is a cross-sectional view of the integral outer film-integrated sealed vial cap shown in Figure 1; Figure 4 is a cross-sectional view of the integral outer film-integrated sealed vial cap shown in Figure 1.

Example 1

As shown in FIGS. 1 and 2 , the integral outer film inner integrated sealed vial cap of the present embodiment comprises a circular body 100, a sealing ring 200 and a rubber plug 300. A first ring wall 400 and a second ring wall 500 are provided on a first side end surface of the circular body 100. A third ring wall 600 is provided on a second side end surface of the circular body 100. The first ring wall 400, the second ring wall 500 and the third ring wall 600 are coaxially arranged. The inner diameter of the first ring wall 400 is greater than the outer diameter of the second ring wall 500. The inner wall of the first ring wall 400, the first side end surface of the circular body 100 and the second ring wall 500 are The outer wall encloses a first injection cavity for injection molding of the sealing ring 200 and is plugged and sealed with the bottle mouth of the vial. The inner wall of the second annular wall 500 and the first side end surface of the circular main body 100 enclose a connecting cavity for connecting to the inner cavity of the vial. The inner wall of the third annular wall 600 and the second side end surface of the circular main body 100 enclose a second injection cavity for injection molding of the plug 300. A puncture portion 110 is provided in the middle of the circular main body 100 to separate the connecting cavity and the second injection cavity. A sealing film 700 is welded and attached to the upper end surface of the third annular wall 600 to seal the upper end opening of the second injection cavity. Specifically, the integral outer film inner integrated sealed vial cap of the present invention, the circular body 100, the first ring wall 400, the second ring wall 500 and the third ring are molded by injection molding at one time, the sealing ring 200 is molded in the first injection molding cavity by injection molding to be plugged and sealed with the bottle mouth of the vial to achieve the sealing of the vial, the plug 300 is molded in the second injection molding cavity by injection molding, the base of the plug 300 is bonded and compatible with the base of the third ring wall 600, the connection is reliable, and the stability is high, the connecting cavity and the second injection molding cavity are separated by the puncture portion 110 to achieve the internal sealing of the plug 300, and the puncture portion 110 is in the circular body The sealing film 700 is welded on the upper end surface of the third ring wall 600 by a welding process to seal the upper end opening of the second injection cavity, thereby achieving surface-to-surface sealing, preventing the rubber plug 300 from contacting the external environment, and achieving tight and reliable sealing. The present invention realizes plug-in sealing through the first injection cavity, and no aluminum powder is generated during the installation process. The rubber plug 300 is formed by a double-material injection molding process, and the rubber plug 300 no longer needs to be fixed by a fixed structure. The internal structure of the syringe bottle cap is simple, and the internal sealing of the rubber plug 300 is achieved by the puncture portion 110, and the external sealing of the rubber plug 300 is achieved by the sealing film 700. The sealing of the rubber plug 300 is tight and reliable. Compared with the prior art, the manufacturing and processing difficulty of the syringe bottle cap is greatly reduced, and no additional disinfection is required during use, which is convenient for medical staff to use, has strong practicality, and is suitable for wide promotion and application.

In this embodiment, the thickness of the puncture portion 110 is 0.3mm-0.5mm. Specifically, the puncture portion 110 is formed together during the injection molding process of the circular body 100. Therefore, when the thickness of the puncture portion 110 is between 0.3mm-0.5mm, the injection molding difficulty of the puncture portion 110 is low and it is convenient for the injection needle to puncture. When the thickness of the puncture portion 110 is less than 0.3mm, it is easy to break during the injection molding process and the injection molding difficulty is high; when the thickness of the puncture portion 110 is greater than 0.5mm, the puncture difficulty is high. Preferably, the thickness of the puncture portion 110 is 0.4mm.

In this embodiment, the lower end of the first annular wall 400 is provided with an arc chamfer and a conical chamfer for guiding the insertion. Specifically, the arc chamfer or the conical chamfer is used to guide the insertion, so as to reduce the difficulty of the insertion.

In this embodiment, a puncture groove for injection needle puncture is concavely provided in the middle of the upper end surface of the rubber plug 300. Specifically, the puncture groove reduces the axial distance when the injection needle punctures the rubber plug 300, so as to reduce the difficulty of puncture.

In this embodiment, the sealing film 700 is provided with an easy-tear edge extending radially outward, and the easy-tear edge is provided with a concave-convex structure for increasing friction. Specifically, the easy-tear edge facilitates tearing of the sealing film 700 to expose the rubber plug 300, and the concave-convex structure increases friction and further reduces the difficulty of tearing.

In this embodiment, the inner wall surface of the first annular wall 400 is radially inwardly provided with a clamping protrusion 410 for clamping with the bottle mouth of the vial. Specifically, the clamping protrusion 410 is clamped with the bottle mouth of the vial to achieve the insertion and fixing of the vial cap.

In this embodiment, the inner diameter of the second ring wall 500 is larger than the outer diameter of the third ring wall 600. Specifically, when using a vial containing a powder injection or a lyophilized drug, a solution needs to be injected with an injection needle first to dissolve the powder injection or the lyophilized drug, so that the drug is arranged in a liquid state, and then another injection needle can be inserted to suck the liquid drug in the vial. In the process of drug dissolution, the vial is often shaken to increase the dissolution rate, so there needs to be enough internal space in the vial to ensure the fluidity of the drug during shaking and vibration. Therefore, by making the inner diameter of the second ring wall 500 larger than the outer diameter of the third ring wall 600, the inner diameter of the connecting cavity is larger than the second injection cavity, and then there is enough internal space to achieve the flow dissolution of the drug inside the vial during oscillation.

Example 2

As shown in FIG3 , the difference between this embodiment and Embodiment 1 lies in that: the second annular wall 500 is provided with a volatilization groove 510 for connecting the first sealing cavity and the connecting cavity, the inner wall of the first annular wall 400 is provided with a limiting protrusion 420 for being squeezed and matched with the bottle mouth of the syringe bottle to limit the bottle mouth of the syringe bottle from continuing to move upward within a preset force, and the vertical height of the volatilization groove 510 is lower than the vertical height of the sealing ring 200. Specifically, when the vial is used to contain freeze-dried drugs, the moisture of the freeze-dried drugs needs to be volatilized during the freezing process. When the first sealed cavity is pressed into the mouth of the vial, the limiting protrusion 420 is squeezed and matched with the mouth of the vial to limit the mouth of the vial from continuing to move upward within the preset force, so that the vial is in a semi-closed state, and the moisture inside can be volatilized through the volatilization groove 510. When all the moisture is volatilized, the circular body 100 is pressed with a force greater than the preset force to completely compact the vial cap, so that the mouth of the vial and the sealing ring 200 are pressed against each other to achieve complete sealing of the vial. Optionally, a plurality of volatilization grooves 510 are arranged at intervals along the circumference of the second annular wall 500.

Example 3

As shown in FIG4 , the difference between this embodiment and embodiment 1 is that the inner diameter of the third ring wall 600 is larger than the outer diameter of the second ring wall 500. Specifically, when using a vial containing a vaccine, it is only necessary to insert an injection needle and then draw out the vaccine. However, since the vaccine dose is relatively small, it is necessary to avoid vaccine residues when the injection needle draws out the vaccine as much as possible. During the drawing process, the vial is usually turned upside down to use gravity to make the vaccine flow into the connecting cavity and be drawn out by the injection needle. At this time, the vaccine in the connecting cavity that is lower than the needle tip of the injection needle cannot be drawn out. Therefore, by making the inner diameter of the third ring wall 600 larger than the outer diameter of the second ring wall 500, so that the inner diameter of the connecting cavity is smaller than the inner diameter of the second injection cavity, so that the internal space of the connecting cavity is relatively small, the amount of vaccine that cannot be drawn out is indirectly reduced, and vaccine residues are avoided as much as possible.

The vial of this embodiment includes the integral outer film inner integrated sealed vial cap of any of the above embodiments. Specifically, the vial mouth of the vial is sealed with the integral outer film inner integrated sealed vial cap, so as to achieve reliable sealing of the rubber plug 300 without generating aluminum powder, and the rubber plug 300 does not need to be fixed with an additional fixing structure, and will not be brought out when the injection needle is punctured or pulled out, which greatly simplifies the internal structure of the vial cap, and the vial has low manufacturing and processing difficulty, low use difficulty, strong practicality, and is suitable for wide promotion and application.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

A whole outer film inner integrated sealed type syringe bottle cap, characterized in that it comprises a circular body (100), a sealing ring (200) and a rubber plug (300), a first side end surface of the circular body (100) is provided with a first ring wall (400) and a second ring wall (500), a second side end surface of the circular body (100) is provided with a third ring wall (600), the first ring wall (400), the second ring wall (500) and the third ring wall (600) are coaxially arranged, the inner diameter of the first ring wall (400) is greater than the outer diameter of the second ring wall (500), and the inner wall of the first ring wall (400), the first side end surface of the circular body (100) and the second ring wall (500) are coaxially arranged. The outer wall of the circular body (100) is enclosed to form a first injection molding cavity for injection molding of a sealing ring (200) and plugged into and sealed with the mouth of a vial; the inner wall of the second annular wall (500) and the first side end surface of the circular body (100) are enclosed to form a connecting cavity for connecting with the inner cavity of the vial; the inner wall of the third annular wall (600) and the second side end surface of the circular body (100) are enclosed to form a second injection molding cavity for injection molding of a rubber plug (300); a puncture portion (110) is provided in the middle of the circular body (100) for separating the connecting cavity and the second injection molding cavity; and a sealing film (700) is welded and attached to the upper end surface of the third annular wall (600) for sealing the upper end opening of the second injection molding cavity.
The integral outer film inner integrated sealed syringe bottle cap according to claim 1 is characterized in that the thickness of the puncture portion (110) is 0.3 mm-0.5 mm.
The integral outer film inner integrated sealed syringe bottle cap according to claim 1 is characterized in that the lower end of the first annular wall (400) is provided with an arc chamfer or a conical chamfer for plugging and guiding.
The integral outer film inner integrated sealed syringe bottle cap according to claim 1 is characterized in that a puncture groove for injection needle puncture is recessed in the middle of the upper end surface of the rubber stopper (300).
The integral outer film inner integrated sealed syringe bottle cap according to claim 1 is characterized in that the sealing film (700) is provided with an easy-tear edge extending radially outward, and the easy-tear edge is provided with a concave-convex structure for increasing friction.
The integral outer film inner integrated sealed syringe bottle cap according to claim 1 is characterized in that the inner wall surface of the first annular wall (400) is radially inwardly provided with a snap-fitting protrusion (410) for snapping with the bottle mouth of the syringe bottle.
The integral outer film inner integrated sealed syringe bottle cap according to claim 1 is characterized in that the second annular wall (500) is provided with a volatilization groove (510) for connecting the first sealed cavity and the connecting cavity, and the inner wall of the first annular wall (400) is provided with a limiting protrusion (420) for squeezing and cooperating with the bottle mouth of the syringe bottle to limit the bottle mouth of the syringe bottle from continuing to move upward within a preset force, and the vertical height of the volatilization groove (510) is lower than the vertical height of the sealing ring (200).
The integral outer film inner integrated sealed syringe bottle cap according to claim 1 is characterized in that the inner diameter of the second ring wall (500) is greater than the outer diameter of the third ring wall (600).
The integral outer film inner integrated sealed syringe bottle cap according to claim 1 is characterized in that the inner diameter of the third ring wall (600) is greater than the outer diameter of the second ring wall (500).
A syringe bottle, characterized by comprising the integral outer film inner integrated sealed syringe bottle cap according to claim 1.