JP4276751B2 - Prefilled syringe - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a prefilled syringe that is shipped in a state in which a medicine is contained.
[0002]
[Prior art]
A prefilled syringe is a syringe configured to store a medicine in a barrel in advance in a sealed state and to be fitted with an injection needle on the distal end side of the barrel at the time of use. It is used.
[0003]
FIG. 7 shows an embodiment of such a conventional prefilled syringe. As shown in FIG. 7, a conventional prefilled syringe 100 includes a cylindrical barrel 110, a seal member 120 that closes the opening at the tip of the barrel, and a tip of the barrel so as to hold the seal member in the closed position. And a cap member 130 to be externally fitted. In use, the medicine contained in the barrel 110 can be dispensed by allowing the injection double-ended needle 50 to penetrate the seal member 120 through the insertion hole 131 formed in the cap member 130. ing.
[0004]
By the way, depending on the kind of chemical | medical agent to accommodate, it may be desired to manufacture the said barrel 110 by glass. This is to eliminate as much as possible the external influence on the medicine to be accommodated. In other words, depending on the type of drug to be stored, it may be required to minimize the evaporation of moisture from the drug and the entry of air from the outside. To meet this requirement, the barrel is made of glass. There is.
[0005]
However, when a glass barrel is used, there are the following disadvantages.
That is, the cap member 130 must be liquid-tightly fitted to the tip of the glass barrel 110. Furthermore, when penetrating the double-ended needle 50 through the seal member 120, a load is also applied to the cap member 130 that holds the seal member 120. Therefore, the cap member needs to be externally fitted to the tip of the glass syringe with a strength that does not wobble even when the load is applied. That is, if the inner diameter of the cap member is too large with respect to the outer diameter of the glass syringe, the cap member wobbles. On the other hand, if the inner diameter of the cap member is too small, the cap member or glass The barrel may be damaged.
Accordingly, the fitting between the cap member and the barrel requires a severe dimensional adjustment of, for example, a level of × 10 ^-2 mm. However, when the barrel is molded using glass, a large manufacturing error of the level of × 10 ⁻¹ mm occurs.
[0006]
For these reasons, conventionally, when a cap member made of a metal material such as aluminum is used, the metal cap member is attached to a glass syringe by tightening, or when a resin cap member is used. After glass barrel molding, the barrel was subjected to a polishing operation to adjust severe dimensions at the level of × 10 ^-2 mm.
[0007]
However, in the former case, there is a problem that aluminum scrap generated during the tightening process may be mixed, or separation and disposal are required at the time of disposal, which is not easy to use.
[0008]
In the latter case, there is a problem that a polishing operation for the glass barrel, and further a cleaning operation and a subsequent drying operation are separately required, resulting in an increase in cost due to an increase in manufacturing steps.
[0009]
[Problems to be solved by the invention]
The present invention has been made to solve the above problems, and in a prefilled syringe having a glass barrel, a special dimension adjustment process is performed on the glass barrel without using a metal cap member. It aims at providing the prefilled syringe which can acquire the sufficient fitting state of a cap member and glass barrels without performing.
[0010]
[Means for Solving the Problems]
In order to achieve the above object, the present invention is a prefilled syringe in which a medicine is previously stored in a sealed state, and has a cylindrical main body portion having a central hole and a cylinder extending further forward from the distal end side of the main body portion. A glass barrel integrally provided with a shape-like pouring portion, a seal member that closes a tip opening of the pouring portion, and a double-ended needle penetrates during use, and is externally fitted to the pouring portion, and the sealing member And a resin cap member to which the double-ended needle is mounted when in use, and the dispensing portion includes a neck portion extending from the main body portion and a shoulder portion extending from the neck portion toward the front. The prefilled syringe further includes a ring member that is externally fitted to the neck portion, and the cap member sandwiches the seal member between a tip portion of the extraction portion. And insertion of the double-ended needle And a peripheral wall portion surrounding the extraction portion and the ring member, and the peripheral wall portion engages with a fitting portion that engages with the flange portion and the shoulder portion. The present invention provides a prefilled syringe having a radially inwardly projecting protrusion and a skirt portion that fits with the ring member, wherein the fitting portion is formed more easily than other portions.
[0013]
The fitting portion can be configured to be thinner than other portions and to be fitted to the flange portion by elastic deformation of the fitting portion.
[0014]
The fitting portion may have a rib projecting radially inward on the inner peripheral surface, and the fitting portion may be configured to fit the flange portion by plastic deformation of the rib.
[0015]
DETAILED DESCRIPTION OF THE INVENTION
Embodiment 1 FIG.
A preferred first embodiment of the present invention will be described below with reference to the accompanying drawings. In FIG. 1, the principal part longitudinal cross-sectional view of the prefilled syringe 1 which concerns on this Embodiment is shown.
[0016]
As shown in FIG. 1, the prefilled syringe 1 is externally fitted so as to surround a glass barrel 10, a seal member 20 that closes a tip opening of the barrel 10, and a tip portion of the barrel 10, And a cap member 30 that holds the seal member 20 in the closed position.
[0017]
The barrel 10 is integrally provided with a cylindrical main body portion 11 having a central hole and a cylindrical extraction portion 12 that extends further forward from the distal end side of the main body portion. The pouring portion 12 includes a neck portion 12a extending from the main body portion 11, and a flange portion 12c extending from the neck portion 12a to the front side along with a shoulder portion 12b.
[0018]
The seal member 20 is configured such that one needle of the double-ended needle 50 is penetrated during use, and can preferably be an elastic member such as rubber.
[0019]
The cap member 30 may be integrally formed of a resin having relatively high rigidity and high creep resistance. The relatively rigid resin means a resin having a flexural modulus of 200 kgf / mm ² or more, preferably a resin having a flexural modulus of 260 kgf / mm ^{2 to} 280 kgf / mm ² , for example, polycarbonate, polysulfone, poly Ether sulfone and the like are included.
[0020]
The cap member 30 includes a peripheral wall portion 32 that is externally fitted to the extraction portion 12 and a contact portion 31 that extends radially inward from the peripheral wall portion. In the present embodiment, the cap member 30 further includes a hollow projecting portion 35 extending forward from the contact portion 31. The protrusion 35 has a central hole 34 through which one of the double-ended needles 50 is inserted, and is elastically fitted to the main body 52 of the double-ended needle 50 so that the double-ended needle 50 can be supported. ing.
[0021]
The abutment portion 31 holds the seal member 20 between the tip of the extraction portion 12 and an insertion hole for the double-ended needle 50 is formed.
[0022]
A peripheral wall portion 32 of the cap member 30 extends downward from a peripheral portion of the abutting portion 31, a fitting portion 32 a that fits with the flange portion 12 c, and a shoulder portion that is positioned below the fitting portion 32 a. It has a projection 32b that engages with 12b and a skirt 32c located below the projection 32b.
[0023]
The fitting portion 32a has an inner diameter slightly smaller than the outer diameter of the flange portion 12c. Preferably, the outer diameter of the flange portion 12c can be 0.1 mm to 0.6 mm smaller.
[0024]
Furthermore, the fitting portion 32a is thinner than other portions of the peripheral wall portion 32, and is thus more easily elastically deformed than other portions. For example, the thickness of the peripheral wall portion 32 other than the fitting portion 32a can be set to 1.0 mm to 2.0 mm, and the thickness of the fitting portion 32a can be reduced by 0.5 mm to 1.5 mm as compared with these. .
[0025]
By configuring in this way, a flange resulting from manufacturing the barrel 10 with glass while obtaining a strong coupling between the cap member 30 and the barrel 10 due to the cap member 30 being manufactured with a relatively high rigidity resin. Easy deformability capable of absorbing the dimensional variation of the portion 12c can be obtained.
[0026]
That is, when the barrel 10 is made of glass, the dimensional variation occurs on the order of × 10 ⁻¹ mm. When the cap member 30 is molded from a relatively flexible resin such as polyethylene or polypropylene, it is possible to absorb manufacturing errors in the glass barrel 10, but the fastening force of the cap member 30 to the barrel is weakened. When the double-ended needle 50 is mounted, the cap member 20 may be displaced (or rattled).
[0027]
On the other hand, in the present embodiment, since the cap member 30 is formed of a relatively rigid resin, the fastening force of the cap member 30 to the barrel 10 can be increased, and the fitting portion 32a. Is made thinner than other parts, it is possible to obtain elastic deformation that absorbs the dimensional variation in the glass barrel 10 in the fitting portion 32a. Furthermore, there are no problems such as generation of metal scraps and separation and disposal when using a metal cap.
[0028]
As shown in FIG. 1, the prefilled syringe 1 according to the present embodiment further includes a ring member 40 that is fitted on the proximal end side of the neck portion 12 a in the extraction portion 12 of the barrel 10.
[0029]
3 (a) is a plan view of the ring member, and FIG. 3 (b) is a cross-sectional view taken along the line AA in FIG. 3 (a). As shown in FIG. 3, the ring member 40 includes a cylindrical main body portion 41 and a flange portion 42 that extends radially outward from a lower end portion of the main body portion 41. A notch 43 is formed to increase flexibility.
[0030]
The ring member 40 can be formed using a relatively highly flexible resin. The said relatively highly flexible resin, flexural modulus 200 kgf / mm ² lower than the resin, preferably, flexural modulus refers to resins ^{30kgf / mm 2 ~100kgf / mm 2} , for example, polyethylene, polypropylene Etc. are included. The reason why the flexibility of the ring member is increased is to obtain the ease of elastic deformation when the ring member is attached to the neck portion via the flange portion of the barrel.
[0031]
As shown in FIG. 1, a hem 33 of the cap member 30 is externally fitted to the main body 41 of the ring member 40.
[0032]
Thus, in the prefilled syringe 1 according to the present embodiment, the cap member 30 is coupled to the neck portion 12a of the barrel 10 via the ring member 40 in addition to the coupling to the flange portion 12c of the barrel 10. As a result, it is possible to effectively prevent the cap member 30 from wobbling when the double-ended needle 50 is mounted.
[0033]
That is, when the double-ended needle 50 is mounted, in addition to moving the double-ended needle 50 toward the seal member 20 in the axial direction, the double-ended needle 50 may be rotated around the axial line. Therefore, in addition to the load in the axial direction, the cap member 30 is subjected to a load in the direction around the axis, and as a result, the cap member 30 may wobble with respect to the barrel 10.
[0034]
On the other hand, in the present embodiment, the cap member 30 is externally fitted to the barrel 10 at two locations of the fitting portion 32a and the skirt portion 32c that are spaced apart in the axial direction across the protrusion 32b. Such a configuration can effectively prevent such inconvenience.
[0035]
Embodiment 2. FIG.
Hereinafter, a preferred second embodiment of the present invention will be described with reference to the accompanying drawings. FIG. 4 is a longitudinal sectional view of the main part of the prefilled syringe 1 ′ according to the present embodiment, and FIG. 5 is a longitudinal sectional view of the cap member 60 in the prefilled syringe 1 ′. Note that the same or corresponding members as those in the first embodiment are denoted by the same reference numerals and description thereof is omitted.
[0036]
As shown in FIG. 4, the prefilled syringe 1 ′ according to the present embodiment includes a cap member 60 instead of the cap member 30 in the first embodiment.
[0037]
As in the first embodiment, the cap member 60 can be formed of a resin having relatively high rigidity such as polycarbonate, polysulfone, or polyethersulfone.
[0038]
As shown in FIGS. 4 and 5, the cap member 60 includes a cylindrical body portion 62 and a contact portion 61 extending radially inward from the inner peripheral surface of the body portion, preferably These components can be integrally formed.
[0039]
A plurality of ribs 63 projecting inward in the radial direction and extending along the axial direction of the cap member are provided on the inner peripheral surface of the body portion 62 below the contact portion 61 with a gap in the circumferential direction. It has been.
[0040]
The inner diameter of the body portion 62 can be the same as or larger than the outer diameter of the flange portion 12c. The rib 63 is formed such that the inner diameter defined by the upper ends of the plurality of ribs is smaller than the outer diameter of the flange portion 12 c of the barrel 10. Preferably, the height of the rib 63 can be 0.1 mm to 0.3 mm. In the figure, reference numeral 64 denotes a protrusion that engages with the shoulder portion 12 b of the barrel 10.
[0041]
Since such a cap member 60 is provided, as in the first embodiment, the cap member 60 and the barrel 10 are strong because the cap member 60 is made of a relatively rigid resin. While obtaining the bond, easy deformability capable of absorbing the dimensional variation of the flange portion 12 caused by manufacturing the barrel 10 with glass can be obtained.
[0042]
That is, when the cap member 60 is attached to the flange portion 12, the rib portion 63 of the cap member 60 undergoes plastic deformation, and the plastic deformation of the rib portion 63 absorbs manufacturing errors of the glass barrel 10. The cap member 60 can be firmly coupled to the barrel 10.
[0043]
In the present embodiment, a screw is formed on the outer peripheral surface of the cap member 60, and the double-ended needle 50 'is mounted via the screw. However, as in the first embodiment, the elastic fitting is performed. It is also possible to do this.
[0044]
In each of the above embodiments, the entire neck portion 12a has a smaller diameter than the flange portion 12c, and a ring member 40 is provided on the base end side (the main body portion 11 side) of the neck portion 12a. Although it is configured to fit the skirt portion 33 of the cap member 30, the same effect can be obtained without using the ring member 40. That is, as shown in FIG. 6, the neck portion 12a ′ of the barrel outlet portion is configured so that the proximal end side has a larger diameter than the distal end side, and the proximal end side of the neck portion 12a ′ and the skirt portion 33 of the cap member are formed. It can also be configured to fit.
[0045]
【The invention's effect】
According to the present invention, in the prefilled syringe having a glass barrel and a resin cap member that is fitted onto the extraction portion of the barrel, the extraction portion includes a neck portion extending from the main body portion and a shoulder portion extending from the neck portion. And the cap member has a protrusion that engages with the shoulder portion and a fitting portion that is externally fitted to the flange portion, and the fitting portion is another member. Since it is easier to deform than the part, a manufacturing error due to the barrel made of glass can be absorbed by deformation of the fitting portion. Therefore, it is possible to stably attach the resin cap member to the glass barrel without adjusting the dimensions of the glass barrel.
[0046]
If it further comprises a flexible ring member that is externally fitted to the proximal end side of the extraction portion, and the peripheral wall portion of the cap member has a skirt portion that is externally fitted to the ring member, The cap member can be stably attached to the barrel.
[Brief description of the drawings]
FIG. 1 is a longitudinal sectional view of a main part of a prefilled syringe according to a preferred first embodiment of the present invention.
FIG. 2 is a longitudinal sectional view of a cap member in the prefilled syringe shown in FIG.
FIG. 3 (a) is a plan view of a ring member in the prefilled syringe shown in FIG.
FIG.3 (b) is the sectional view on the AA line in Fig.3 (a).
FIG. 4 (a) is a longitudinal sectional view of an essential part of a prefilled syringe according to a preferred second embodiment of the present invention.
It is a principal part front view of the prefilled syringe shown in FIG.4 (b) and FIG.4 (a).
FIG. 5 is a longitudinal sectional view of a cap member in the prefilled syringe shown in FIG. 4;
FIG. 6 is a longitudinal sectional view of a main part of a prefilled syringe according to another embodiment of the present invention.
FIG. 7 is a partial longitudinal sectional view showing a conventional prefilled syringe.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Prefilled syringe 10 Barrel 11 Main body part 12 Extraction part 12a, 12a 'Neck part 12b Shoulder part 12c Flange part 20 Seal member 30 Cap member 31 Contact part 32 Peripheral wall part 32a Fitting part 32b Protrusion part 32c Bottom part 40 Ring member 50 Both heads needle

Claims (3)

A prefilled syringe in which a medicine is stored in a sealed state in advance,
A glass barrel integrally provided with a cylindrical main body portion having a central hole and a cylindrical extraction portion extending further forward from the front end side of the main body portion;
A sealing member that closes the distal end opening of the extraction portion and allows a double-ended needle to penetrate during use;
A resin cap member that is externally fitted to the extraction portion and holds the seal member in a closed position and to which the double-ended needle is attached during use.
The pouring portion has a neck portion extending from the main body portion, and a flange portion extending from the neck portion with a shoulder portion,
Furthermore, the prefilled syringe includes a ring member that is fitted on the neck,
The cap member sandwiches the seal member between the tip portion of the extraction portion and a contact portion in which an insertion hole for the double-ended needle is formed, and a peripheral wall surrounding the extraction portion and the ring member And
The peripheral wall portion includes a fitting portion that fits with the flange portion, a radially inward protruding protrusion that engages with the shoulder portion, and a skirt portion that fits with the ring member,
A prefilled syringe, wherein the fitting portion is formed more easily than other portions. The fitting part is thinner than other parts,
The prefilled syringe according to claim 1, wherein the prefilled syringe is configured to be fitted to the flange portion by elastic deformation of the fitting portion. The fitting portion has a rib protruding radially inward on the inner peripheral surface,
The prefilled syringe according to claim 1 or 2 , wherein the fitting portion is configured to be fitted to the flange portion by plastic deformation of the rib.

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