JP2005027877A - Mouth member, method of producing the same, and medicine container using the same - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a mouth member into which a piercing tool whose tip is not sharp can be inserted to reliably achieve asepsis and removal of foreign matters inside a slit, and to provide a method for producing the mouth member and a medicine container using the mouth member. <P>SOLUTION: In a hollow part 12 of an external body 11, an elastic body 16 provided with a pore 18 extending therethrough in an axial direction (x) is arranged. After sterilization treatment of the mouth member 10, the elastic body 16 is compressed from a direction (y) orthogonal to the axial direction (x) to close the pore 18 to make the slit. Since the elastic body 16 is provided with the slit, the piercing tool whose tip is not sharp can be inserted into the mouth member. Since the pore 18 can be formed simultaneously with molding of the elastic body within a mold, the problem that chips would remain after forming of the slit is solved. In addition, since sterilizing treatment is carried out before closing the pore 18, asepsis inside the slit is reliably attained. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

[0001]
【Technical field】
The present invention relates to a mouth member provided with a stopper made of an elastic body, a manufacturing method thereof, and a drug container using the same.
[0002]
[Background]
Usually, the mouth portion of a drug container such as an infusion bag or an infusion bottle for storing an infusion solution or an injection solution is sealed with a plug made of an elastic material such as rubber or thermoplastic elastomer. For this reason, a sharp piercing tool such as a metal injection needle that can pierce the stopper has been used when taking out the contents of the medicine container or injecting the medicine into the container. If a puncture device having a sharp tip is used, there is a risk of accidents such as accidental puncture of a finger, and use of a piercing device having a sharp tip is required from the viewpoint of infectious disease countermeasures.
[0003]
Therefore, in recent years, attempts have been made to allow insertion of a piercing tool having a sharp tip by providing a cut (slit) in the plug (see Patent Document 1). However, since the blade is pierced through the elastic body when the slit is formed, there is a possibility that chips of the elastic body remain in the slit and are mixed into the medicine container at the time of use. In addition, even if a sterilization process such as heat sterilization or gas sterilization is performed on a drug container or the like, sterility cannot be reliably ensured because a heating medium or gas does not enter the slit of the stopper. .
[0004]
[Patent Document 1]
Japanese Patent Laid-Open No. 5-124664 (paragraph [0009], FIGS. 1 and 4)
[Patent Document 2]
JP 2002-126040 A (paragraphs [0007] to [0009], FIGS. 1 and 2)
[0005]
[Problems to be solved by the invention]
Accordingly, an object of the present invention is to insert a piercing tool having a sharp tip, which can reliably achieve sterility and removal of foreign matter in the slit, a manufacturing method thereof, and such a mouth. It is providing the chemical | medical agent container using a member.
[0006]
[Means for Solving the Problems]
In order to achieve the above object, the mouth member of the present invention is formed by disposing a substantially disc-shaped elastic body in the hollow portion of the outer frame body having a substantially cylindrical hollow portion, Is provided with pores penetrating in the axial direction, and the pores are closed by compressing the elastic body from a direction perpendicular to the axial direction after the sterilization treatment of the mouth member. .
[0007]
In the mouth member of the present invention, since the elastic body is provided with pores in advance and sterilized and compressed and deformed into a slit shape, even if the tip is not sharp, the slit The inside can be easily inserted. In addition, unlike the slits, the pores provided in advance in the elastic body can be formed simultaneously with the molding of the elastic body in the mold, resulting in the problem that the aforementioned chips remain. There is no. Furthermore, since the sterilization process is performed before the pores are closed and slitted, sterility inside the slit can be reliably achieved. Moreover, since the slit portion of the elastic body is subjected to compression from the direction orthogonal to the axial direction, liquid leakage from the elastic body occurs when the piercing tool is inserted or after it is removed. It does not occur. For the above reasons, the mouth member of the present invention is suitable, for example, as a mouth member of a drug container.
[0008]
In the mouth member of the present invention, the pores are
(1) The elastic body may be closed by being fitted into the cavity of the outer frame while being compressed,
(2) It may be closed by pressing a wedge between the outer peripheral surface of the elastic body and the inner surface of the cavity of the outer frame.
In the case of the above embodiment (1), the pores provided in advance in the elastic body can be closed by moving the elastic body to the fitting position in the cavity of the outer frame and compressing it. . On the other hand, in the case of the above embodiment (2), the elastic body is compressed by inserting a wedge between the outer peripheral surface of the elastic body and the inner surface of the hollow portion of the outer frame, and is provided in advance in the elastic body. The pores can be closed. That is, in either case of (1) and (2) above, the elastic body is not provided with slits in advance, but is provided with pores that are easier to form than the slits. By simply moving the inside of the cavity or press-fitting a wedge between the elastic body and the cavity, the liquid can be passed and leaked while maintaining the piercing property of the puncture tool such as an injection needle. It can be set as the slit which can be prevented. Furthermore, as a result, even when the sterilization process is performed on the drug container including the mouth member according to the above-described embodiment in a state where the pores of the elastic body are not closed, the elastic body after the sterilization process By passing through a simple process such as movement of the wedge and press-fitting of the wedge, the pores of the elastic body can be made into slits and the sealing performance can be given to the mouth member.
[0009]
Patent Document 2 describes a cap in which an elastic body is provided with pores in advance and is compressed and deformed by press-fitting a wedge to make a slit. Is not described or suggested.
In the mouth member of the present invention, the elastic body may have been previously sterilized after being placed in the cavity of the outer frame body, or after being sterilized separately from the outer frame body, You may arrange | position in the cavity part of the outer frame which is a sterilization state.
[0010]
In the above embodiment (1), it is preferable that the elastic body before compression has a substantially elliptical plate shape, and the major axis is larger than the inner diameter of the cavity at the fitting position in the cavity of the outer frame. By setting the relationship between the shape of the elastic body before compression and the size in the outer frame body cavity as described above, the elastic body is moved to the fitting position in the cavity of the outer frame body and compressed. In addition, the pores can be efficiently compressed and closed to form slits.
[0011]
In the above embodiment (1), it is preferable that the pores in the elastic body before compression are substantially elliptical in the horizontal cross section, and that the major axis is arranged in a direction perpendicular to the major axis of the elastic body. By setting the shape and direction of the pores as described above, the pores can be efficiently compressed and closed to form slits when the elastic body is compressed.
In the embodiment (2), it is preferable that the pores in the elastic body before compression have a substantially elliptical shape in the horizontal cross section and are compressed in the minor axis direction by a wedge. By setting the shape and direction of the pores as described above, the pores can be efficiently compressed and closed to form slits when the elastic body is compressed.
[0012]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.
<First Embodiment>
In the first embodiment of the present invention, for example, as shown in FIG. 1, a substantially disk-shaped elastic body 16 is disposed in the cavity of an outer frame 11 having a substantially cylindrical cavity, By fitting the elastic body 16 into the cavity while compressing the elastic body 16 after sterilization, the pores provided in advance in the elastic body 16 are closed to form a slit 18 '.
[0013]
FIG. 2 shows a state before the sterilization process of the mouth member 10 shown in FIG. 1 (note that the end of the inner frame 19 is omitted). Although the elastic body 16 before sterilization is disposed in the cavity 12 of the outer frame body 11, it is fixed at a position different from the fitting position 12a. In this state, as shown in FIG. 3 (b), the pore 18 penetrates in the axial direction x of the elastic body 16. The pore 18 is closed by compressing the elastic body 16 and arranging and fixing the elastic body 16 at the fitting position 12a of the cavity portion to form a slit 18 'as shown in FIG. 3A is a plan view of the elastic body 16 in the state shown in FIG. 1, and FIG. 3B is a plan view of the elastic body 16 in the state shown in FIG. 1 and 2 are cross-sectional views in the direction of arrows AA shown in FIGS. 3 (a) and 3 (b), respectively.
[0014]
In the mouth member 10 shown in FIG. 1 and FIG. 2, the elastic body 16 is formed into a substantially elliptical plate shape before compression [see FIG. 3 (b)]. By setting the major axis 16a of the elastic body 16 to be larger than the inner diameter of the cavity portion 12 at the fitting position 12a of the outer frame body 11, the elastic body 16 is automatically disposed at the fitting position 12a to thereby reduce the pores. 18 is compressed and closed to form a slit 18 'as shown in FIG.
[0015]
Although it does not specifically limit in this invention, it is preferable to set the long diameter 16a of the elastic body 16 2-15% larger than the short diameter 16b, and it is more preferable to set 5-10% larger. Further, the major axis 16a of the elastic body 16 is preferably set to be 5 to 15% larger than the inner diameter of the cavity 12 at the fitting position 12a of the outer frame body 11, and more preferably 8 to 12% larger.
In the mouth member 10 shown in FIGS. 1 and 2, the pores 18 of the elastic body 16 are arranged such that the major axis 18a is orthogonal to the major axis 16a of the elastic body 16 (see FIG. 3B). The direction in which the elastic body 16 is compressed is the same as the direction of the major axis 16a of the elastic body in the direction y orthogonal to the axial direction x of the elastic body 16. Therefore, by making the direction of the minor axis 18b of the pore the same as the direction of the major axis 16a of the elastic body, the efficiency when closing the pore 18 to form the slit 18 ′ is improved, and as a result, the elastic body It is possible to prevent liquid leakage or the like from occurring in a state where the puncture tool 16 is not pierced.
[0016]
In the mouth member 10 shown in FIG. 1 and FIG. 2, the elastic body 16 is configured such that the ridge 13 provided on the inner peripheral surface of the outer frame body 11 is engaged with the groove portion 20 a of the inner frame body 19. It is fixed at the temporary fixing position. In this state, the pore 18 penetrates in the axial direction x of the elastic body 16 without being closed (see FIGS. 2 and 3B). On the other hand, since the diameter of the inner peripheral surface of the outer frame body 11 is set narrow at the fitting position 12a, the inner frame body 19 is further pushed into the cavity portion 12 to engage the ridge 13 with the groove portion 20b. As a result, the elastic body 16 is fixed at the locking position in the cavity 12 and the pores are closed by compression to form slits 18 ′ (see FIGS. 1 and 3A).
[0017]
In the mouth member 10 according to the first embodiment, the ridges 14 provided on the inner peripheral surface of the outer frame body 11 and the ridges 21 provided on the end portion of the inner frame body 19 are respectively the elastic body 16. The elastic body 16 is more reliably fixed in the cavity 12 of the outer frame body 11 by engaging with the groove portion 17a on the top surface and the ridges 17b on the bottom surface. The elastic body 16 is fixed at a temporarily fixed position in the cavity portion 12 by the engagement between the convex strip 13 of the outer frame body 11 and the groove portion 20a of the inner frame body 19, and the convex strip 13 and the groove portion 20b of the inner frame body. Are engaged, and the flange portion 15 of the outer frame body and the flange portion 22 of the inner frame body are engaged with each other, thereby being fixed at the locking position in the cavity portion 12.
[0018]
In the mouth member 10 shown in FIG. 1, a puncture member holding portion 23 is provided inside the inner frame body 19. The puncture member holding portion 23 is a member that holds a puncture device such as an injection needle that has pierced the elastic body 16, and can thereby improve the stability in a state in which the puncture device is pierced.
In the mouth member 10 shown in FIG. 1, a thin film 24 is provided inside the inner frame body 19. By providing this thin film 24, even if sterilization is performed with the pores 18 penetrating the elastic body 16, the contents of the drug container to which the mouth member 10 is connected are adversely affected by sterilization. It can be prevented from occurring.
[0019]
FIG. 4 is a perspective view showing a medicine container (infusion bag) 25 including the mouth member 10 shown in FIG. The mouth member 10 shown in FIG. 1 is used, for example, by holding the end portion of the inner frame body 19 between the peripheral edge portion 27 of the container body 26.
<Second Embodiment>
In the second embodiment of the present invention, for example, as shown in FIG. 5, a substantially disc-shaped elastic body 36 is arranged in the cavity of the outer frame 31 having a substantially cylindrical cavity, By inserting a wedge 40 between the outer peripheral surface of the elastic body 36 and the inner peripheral surface of the hollow portion after sterilization, the pores provided in advance in the elastic body 36 are closed to form a slit 18 '. is there.
[0020]
FIG. 6 shows a state before the sterilization process of the mouth member 30 shown in FIG. 5 (note that the end of the inner frame 39 is omitted). Although the elastic body 36 before sterilization is disposed in the cavity of the outer frame body 11, it is disposed at a position different from the fixed position. In this state, the pore 18 penetrates in the axial direction x of the elastic body 36. The pore 18 is closed by press-fitting a wedge between the elastic body 36 and the outer frame 31 to form a slit 18 ′ as shown in FIG. FIG. 7A is a cross-sectional view taken along the line BB in FIG. 5 and shows a state in which the wedge 40 is press-fitted between the inner peripheral surface of the outer frame 31 and the outer peripheral surface of the elastic body 36. On the other hand, FIG. 7B is a cross-sectional view taken along the line CC of FIG. 5 and shows a state in which the wedge 40 is not press-fitted between the inner peripheral surface of the outer frame 31 and the outer peripheral surface of the elastic body 36. Yes. 5 and 6 are cross-sectional views in the direction of the arrows DD shown in FIGS. 7 (a) and 7 (b), respectively.
[0021]
In the mouth member 30 shown in FIGS. 5 and 6, the pores 18 of the elastic body 36 are arranged so that the major axis thereof is orthogonal to the major axis of the elastic body 16 (see FIGS. 7A and 7B). . The direction in which the elastic body 36 is compressed is the same direction as the major axis direction of the elastic body 36 in the direction y orthogonal to the axial direction x of the elastic body 36. Therefore, by making the direction of the minor axis of the pore 18 the same as the direction of the major axis of the elastic body 16, the efficiency when closing the pore 18 to form the slit 18 ′ is improved. As a result, the elastic body It is possible to prevent liquid leakage or the like from occurring in a state where the puncture tool is not pierced through 36.
[0022]
In the mouth member 30 shown in FIG. 5 and FIG. 6, the elastic body 36 has the cavity 32 by engaging the ridges 13 provided on the inner peripheral surface of the outer frame 31 with the groove 20 a of the inner frame 39. Placed inside. In this state, no pressure is applied to the elastic body 36 in the direction (horizontal direction) y orthogonal to the axial direction x, so that the pores 18 are not closed and penetrate in the axial direction x [FIG. And FIG. 7 (b)]. On the other hand, since the wedge 40 is provided at the end of the inner frame body 39, the elastic body 36 is formed by pushing the inner frame body 39 further into the cavity 32 and engaging the ridge 13 with the groove 20b. Are closed by compression to form a slit 18 ′ (see FIGS. 5 and 7A).
[0023]
In the mouth member 30 shown in FIGS. 5 and 6, the ridges 14 provided on the inner peripheral surface of the outer frame body 31 and the ridges 21 provided at the end of the inner frame body 39 are the above-mentioned mouth member 10. As in the case of the above, the elastic body 36 is more securely fixed in the hollow portion 32 of the outer frame body 31 by engaging with the protrusions 37a on the top surface and the protrusions 37b on the bottom surface of the elastic body 36, respectively. It is said. The elastic body 36 is a cavity formed by engaging the ridge 13 of the outer frame 31 and the groove 20b of the inner frame 39 and engaging the flange 15 of the outer frame and the flange 22 of the inner frame. It is fixed in the part 32.
[0024]
In the mouth member 30 shown in FIG. 5, the elastic body 36 is compressed by the wedge 40 connected to the inner frame 39. Instead of the wedge 40, for example, a wedge material as shown in Patent Document 2 is used. The elastic body 36 may be compressed by using it. However, in this case, it is inevitable that the number of parts increases.
As in the case of the medicine container (see FIG. 4) using the mouth member 10 shown in FIG. 1, the mouth member 30 shown in FIG. Used by.
[0025]
<Third Embodiment>
In the third embodiment of the present invention, for example, as shown in FIG. 8, a substantially disc-shaped elastic body 16 is disposed in the cavity of the outer frame 11 having a substantially cylindrical cavity, By fitting the elastic body 16 into the cavity while compressing the elastic body 16 after sterilization, the pores provided in advance in the elastic body 16 are closed to form a slit 18 '. The mouth member 50 is a cap-like member used by being attached to the flange 47 of the mouth portion of the medicine container main body 46. The configuration of the mouth member (cap) 50 is the same as that of the mouth member 10 shown in FIGS. 1 and 2 except that an inner frame body 49 is used instead of the inner frame body 19 of the mouth member 10 shown in FIG. It is.
[0026]
The mouth member according to the third embodiment of the present invention is used by attaching the end portion of the inner frame body 19 to the peripheral portion 27 (see FIG. 4) such as an infusion bag as shown in the first embodiment. Instead, as described above, the flange portion 22 of the inner frame 49 is attached to the flange 47 of the mouth portion of an infusion bottle or the like.
The shape of the mouth member (cap) according to the third embodiment is not particularly limited except that the bottom surface portion of the inner frame is a shape suitable for being attached to the mouth flange of the drug container, As the structure of the mouth member (cap) 50, the same structure as that of the mouth member 30 shown in FIGS. 5 and 6 may be employed.
[0027]
<Sterilization method>
In the present invention, the sterilization treatment for the mouth member is not particularly limited, and for example, heat sterilization such as high-pressure steam sterilization can be employed. However, in the present invention, it is preferable to employ ethylene oxide gas sterilization that does not require drying after sterilization and does not adversely affect the material of the elastic body.
[0028]
<Outer frame>
Various conventionally known thermoplastics can be used for the outer frame body in the mouth member of the present invention. In particular, when the mouth member of the present invention is used for a medicine container, a thermoplastic plastic (including a polymer and an elastomer) permitted for medical instruments may be used as a material for forming the outer frame. Examples of such thermoplastic plastics include polyethylene, polypropylene, poly-4-methylpentene [for example, trade name “TPX” of Mitsui Chemicals, Inc.], polyolefins such as polytetrafluoroethylene; ethylene-tetracyclododecene copolymer [For example, polycyclic olefins such as Mitsui Chemicals' trade name “Apel”]; polyacetal (POM); acrylonitrile-butadiene-styrene copolymer (ABS); polyethylene naphthalate (PEN), polyethylene terephthalate (PET) And polyesters such as polyarylate; and benzene polymers such as polyphenylene sulfide (PPS).
[0029]
<Elastic body>
Various conventionally known thermoplastic resins and thermoplastic elastomers can be used for the elastic body in the mouth member of the present invention. In particular, when the mouth member of the present invention is used for a drug container, a thermoplastic resin (above) or a thermoplastic elastomer allowed for a medical device may be used as a material for forming an elastic body. Examples of such thermoplastic elastomers include styrene-based thermoplastic elastomers, olefin-based thermoplastic elastomers, polyurethane-based thermoplastic elastomers, and the like.
[0030]
The thickness of the elastic body is set according to the use of the mouth member, the type of puncture device to be used, etc., and is not particularly limited, but is usually in the range of 1 to 10 mm, preferably 1 It is set in the range of 5 to 5 mm.
<Pore>
In the mouth member of the present invention, the shape of the pores provided in advance in the elastic body is not particularly limited, and various shapes such as a circle, an ellipse, and an eye shape can be adopted as the horizontal cross section. .
[Brief description of the drawings]
FIG. 1 is a longitudinal sectional view showing an embodiment of a mouth member according to the present invention.
2 is a longitudinal sectional view showing a state of the mouth member 10 shown in FIG. 1 before sterilization.
3A is a plan view of the elastic body 16 in the mouth member 10 shown in FIG. 1, and FIG. 3B is a plan view of the elastic body 16 shown in FIG.
4 is a perspective view showing an example of a medicine container including the mouth member 10 shown in FIG. 1. FIG.
FIG. 5 is a longitudinal sectional view showing another embodiment of the mouth member according to the present invention.
6 is a longitudinal sectional view showing a state before the sterilization process of the mouth member 30 shown in FIG. 5. FIG.
7A is a plan view of the elastic body 36 in the mouth member 30 shown in FIG. 5, and FIG. 7B is a plan view of the elastic body 36 shown in FIG.
FIG. 8 is a longitudinal sectional view showing still another embodiment of the mouth member according to the present invention.
[Explanation of symbols]
10, 30, 50 Mouth member 11, 31 Outer frame body 12, 32 Cavity 12a Fitting position 16, 36 Elastic body 16a Long diameter 18 Pore 25 Drug container 40 Wedge x Axial direction

Claims (10)

A mouth member formed by disposing a substantially disc-shaped elastic body in the cavity of the outer frame having a substantially cylindrical cavity,
The elastic body is provided with pores penetrating in the axial direction, and the pores are closed by compressing the elastic body from a direction orthogonal to the axial direction after sterilization of the mouth member. A certain mouth member. The mouth member according to claim 1, wherein the pore is closed by fitting into the cavity of the outer frame body while compressing the elastic body. The mouth member according to claim 2, wherein the elastic body before compression has a substantially elliptical plate shape, and a major axis thereof is larger than an inner diameter of the hollow portion at a fitting position in the hollow portion. The mouth member according to claim 3, wherein the pores in the elastic body before compression are substantially elliptical in the horizontal cross section, and the major axis is arranged in a direction perpendicular to the major axis of the elastic body. The mouth member according to claim 1, wherein the pore is closed by pressing a wedge between the outer peripheral surface of the elastic body and the inner surface of the cavity portion of the outer frame body. 6. The mouth member according to claim 5, wherein the pores in the elastic body before compression are substantially elliptical in the horizontal cross section and are compressed in the minor axis direction by the wedge. The mouth member according to any one of claims 1 to 6, wherein the sterilization treatment is performed by sterilization with ethylene oxide gas. A substantially disc-shaped elastic body is disposed in the hollow portion of the outer frame body having a substantially cylindrical hollow portion, and after sterilization, the elastic body is compressed and fitted into the hollow portion of the outer frame body. Thus, the method of manufacturing the mouth member, comprising compressing and closing the pores penetrating in the axial direction of the elastic body from a direction orthogonal to the axial direction. After disposing a substantially disc-shaped elastic body in the hollow portion of the outer frame body having a substantially cylindrical hollow portion and sterilizing, the outer peripheral surface of the elastic body and the inner surface of the hollow portion of the outer frame body A method of manufacturing a mouth member, wherein a wedge is press-fitted between the two and a pore penetrating in an axial direction of an elastic body is compressed and closed in a direction perpendicular to the axial direction. A medicine container provided with the mouth member according to any one of claims 1 to 7.

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