JP2016073364A - Assembly for syringe, assembly package for syringe, and prefilled syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an assembly for a syringe using an outer cylinder with a puncture needle, and a cap mounted to the outer cylinder which is composed of a seal cap made of an elastic material and a hard cylindrical encapsulation member in which the entire cap can be detached reliably even after the high pressure steam sterilization.SOLUTION: An assembly 10 for a syringe includes an outer cylinder 2 with a puncture needle, and a cap 3 mounted to the outer cylinder 2 which a needle tip 61 of a puncture needle 6 pierces. The cap 3 includes a seal cap formed of an elastic material that has water vapor permeability for high pressure steam sterilization, and a cylindrical encapsulation member 8 formed of thermoplastic material harder than the seal cap 7. In the cap 3, the engaging force between the cylindrical encapsulation member 8 and the seal cap 7 increases by the high pressure steam sterilization compared to the engaging force before the sterilization.SELECTED DRAWING: Figure 4

Description

  The present invention relates to a syringe assembly equipped with an outer cylinder seal cap, a prefilled syringe using the syringe assembly equipped with an outer cylinder seal cap, and a package containing a plurality of syringe assemblies.

  As syringes for small doses of drugs such as insulin syringes, those with a puncture needle fixed to the outer cylinder tip are used. And when comprising the prefilled syringe which filled the chemical | medical agent beforehand inside using such a type of syringe, it is necessary to seal a needle point. As such a seal cap capable of needle tip sealing, for example, one disclosed in US Pat. No. 6,719,732 (Patent Document 1) has been proposed.

USP 6719732

  The seal cap (device for protecting the syringe needle) of Patent Document 1 (USP 6719732) includes an elastic cap 20 and a hard shell 80 attached to the cap 20, as shown in FIGS. The shell 80 is difficult to pierce the needle 106. The longitudinal wall 88 of the shell 80 is also provided with four notches 94 to allow the passage of water vapor. The shell 80 includes cap holding means for holding the cap 20 on the inner surface. As the holding means, a protruding portion 96 protruding inside the cavity is provided.

  Usually, when the cap constituted by the hard shell and the elastic cap as described above is removed from the syringe, the hard shell and the seal cap are integrally removed. However, since the seal cap is in close contact with the syringe, when removing the cap, the hard cover may come off from the seal cap, and only the seal cap may remain attached to the outer cylinder. In particular, in the case of high-pressure steam sterilization (autoclave sterilization), the seal cap is easily fixed by a syringe due to heat during sterilization, and the risk is increased.

  Accordingly, the object of the present invention is to store the syringe with the seal cap attached to the outer cylinder, or to sterilize the syringe assembly equipped with the seal cap with heating such as high-pressure steam sterilization. , A syringe assembly equipped with an outer cylinder seal cap capable of reliably removing the entire cap, a prefilled syringe using the syringe assembly equipped with an outer cylinder seal cap, and a syringe assembly Provides a packaged body in which a plurality of sheets are stored.

What achieves the above object is as follows.
(1) A puncture having an outer cylinder main body, a cylinder tip provided at the distal end of the outer cylinder main body, a puncture needle tip at the distal end, and a base end inserted into and fixed to the cylinder tip A syringe assembly comprising: an outer cylinder including a needle; and a cap attached to the outer cylinder and sealing the puncture needle tip;
The cap includes a closed distal end portion, an opening proximal end portion, a hollow portion having a puncture needle storage portion for storing the puncture needle, and the puncture needle tip of the puncture needle stored in the puncture needle storage portion. A seal cap including a pierceable portion capable of being inserted and a seal portion that seals the puncture needle storage portion by being in close contact with the tube tip portion; A cylindrical enveloping member,
The seal cap is formed of an elastic material and has water vapor permeability for high-pressure steam sterilization, and the cylindrical encapsulating member is made of a thermoplastic material harder than the seal cap, and An assembly for a syringe in which an engagement force between the cylindrical encapsulating member and the seal cap is increased by autoclave sterilization of the syringe assembly than before sterilization.

(2) The syringe assembly according to (1), wherein the engagement force is increased as compared to that before sterilization by deforming the cylindrical encapsulating member by heat during autoclave sterilization.
(3) The cylindrical envelope member has an internal protrusion provided on the inner surface of the cylindrical envelope member so as to engage with the seal cap, and the internal protrusion due to heat during autoclave sterilization. The syringe assembly according to the above (1) or (2), wherein the engagement force is increased more than before sterilization due to the displacement toward the inside.
(4) The syringe assembly according to (3), wherein the internal projecting portion extends obliquely in the central axis direction and the distal end direction of the cylindrical enveloping member and is elastically deformable.

(5) The cylindrical envelope member has an internal protrusion provided on the inner surface of the cylindrical envelope member to engage with the seal cap, and the internal protrusion is the cylindrical envelope member. (1) thru | or (1) thru | or provided with the opening part extended in the front-end | tip direction from the base end part of each said internal protrusion part. 4) The syringe assembly according to any one of the above.
(6) The cylindrical encapsulating member includes a side enveloping portion that covers a side surface of the seal cap, and a tip enveloping portion that covers a closed tip end portion of the seal cap, and the tip encapsulating portion includes the seal The cap according to any one of (1) to (5), wherein the cap has a facing inner surface facing the tip surface of the closing tip portion of the cap, and a gap is formed between the facing inner surface and the closing tip portion. Assembly for syringe.

(7) The tip encapsulation portion of the cylindrical encapsulation member includes a plurality of frames connected to the distal end portion of the side surface encapsulation portion, and a through hole is formed between the adjacent frames. The assembly for a syringe according to (6) above.
(8) The cylindrical encapsulating member includes a corner portion that is formed at a boundary portion between a base end of the frame and a distal end of the side enveloping portion in a side view and faces the distal end direction. An assembly for a syringe according to 1.
(9) The cylindrical enveloping member has a through hole provided at a tip portion, and the cap is formed by an inner surface of the cylindrical enveloping member and an outer surface of the seal cap, and the through hole 9. The syringe assembly according to any one of the above (1) to (8), further comprising a vapor guiding gap extending to the base end of the puncture needle storage portion of the seal cap.

(10) The seal portion of the seal cap is in a state where the tube tip portion is housed and is spread outward by a tip portion of the housed tube tip portion, and the steam guide in the seal portion is used. The assembly for a syringe according to the above (9), wherein the gap portion has an air gap distance narrower than other portions.
(11) The syringe assembly according to any one of (1) to (10), wherein the cylindrical encapsulating member is attached to the seal cap after the seal cap is attached to the outer cylinder. .
(12) The syringe assembly according to any one of (1) to (11), wherein the syringe assembly is autoclaved.

Moreover, what achieves the said objective is as follows.
(13) The syringe assembly according to any one of (1) to (12), a gasket that is housed in the outer cylinder and is capable of sliding in a liquid-tight manner in the outer cylinder, and the outer cylinder; A prefilled syringe comprising a medicine filled in a space formed by the gasket.

Moreover, what achieves the said objective is as follows.
(14) A syringe assembly package housing the syringe assembly according to any one of (1) to (12) above,
The packaging body includes a container body having an open top surface and shape retention, an outer cylinder holding member capable of holding the plurality of syringe assemblies, and a plurality of syringes held by the outer cylinder holding member. An assembly, and a sheet-like lid member that hermetically seals and peels off the upper surface opening of the container body, and the packaging body is impermeable to bacteria provided in the container body or the lid member An assembly package for a syringe which is provided with a vent having sterilization gas flow and is sterilized under high pressure steam.

The syringe assembly of the present invention has an outer cylinder main body, a cylinder tip provided at the distal end of the outer cylinder main body, a puncture needle tip at the distal end, and a proximal end inserted into the cylinder tip. A syringe assembly including an outer cylinder including a fixed puncture needle, and a cap attached to the outer cylinder and sealing a puncture needle tip, the cap including a closed distal end portion and an open proximal end portion And a hollow portion having a puncture needle storage portion for storing the puncture needle, a puncture needle tip of the puncture needle stored in the puncture needle storage portion, and a puncturable needle portion, and a tube tip portion A seal cap that includes a seal portion that seals the puncture needle storage portion, and a cylindrical envelope member that is attached to the outside of the seal cap and engages with the seal cap, and the seal cap is formed of an elastic material, and , Having water vapor permeability for high pressure steam sterilization, Made from a hard thermoplastic material than Rukyappu, and by high-pressure steam sterilization of the assembly for a syringe, the engaging force between the cylindrical encapsulating member and the seal cap has to increase by than prior to sterilization.
In this syringe assembly, when sterilization with heating such as high-pressure steam sterilization is selected, the engagement force between the cylindrical encapsulating member and the seal cap increases more than before sterilization. At this time, only the cylindrical encapsulating member is detached from the outer cylinder, and the sea cap is not left in the outer cylinder, so that the entire cap can be reliably removed.

FIG. 1 is a front view of a prefilled syringe according to an embodiment of the present invention. FIG. 2 is a right side view of the prefilled syringe of FIG. 3 is a cross-sectional view taken along line AA in FIG. FIG. 4 is a partially omitted enlarged cross-sectional view of the syringe assembly of the present invention used in the prefilled syringe of FIGS. 1 and 2. FIG. 5 is an enlarged front view of the outer cylinder seal cap of the present invention used in the prefilled syringe of FIGS. 1 to 3 and the syringe assembly of FIG. 4. 6 is a cross-sectional view taken along line BB in FIG. FIG. 7 is an enlarged right side view of the cylindrical envelope member used in the prefilled syringe shown in FIGS. 1 to 3 and the syringe assembly shown in FIG. FIG. 8 is a longitudinal sectional view of the cylindrical enveloping member of FIG. 9 is a cross-sectional view taken along the line CC of FIG. FIG. 10 is an enlarged plan view of the cylindrical enveloping member of FIG. 11 is an enlarged bottom view of the cylindrical enveloping member of FIG. FIG. 12 is a perspective view of the cylindrical enveloping member shown in FIG. 13 is an enlarged front view of a seal cap used in the prefilled syringe shown in FIGS. 1 to 3 and the syringe assembly shown in FIG. 14 is a longitudinal sectional view of the seal cap of FIG. FIG. 15 is a bottom view of the seal cap shown in FIG. 16 is a front view of an outer cylinder with a puncture needle used in the prefilled syringe shown in FIGS. 1 to 3 and the syringe assembly shown in FIG. FIG. 17 is a perspective view of the outer cylinder with a puncture needle shown in FIG. FIG. 18 is a perspective view of the syringe assembly package of the present invention. FIG. 19 is an explanatory diagram for explaining an internal configuration of the assembly package for a syringe illustrated in FIG. 18. FIG. 20 is a front view of the syringe assembly package shown in FIG. 21 is a plan view of the syringe assembly package shown in FIG. 22 is an enlarged sectional view taken along the line DD of FIG.

A syringe assembly equipped with the outer cylinder seal cap of the present invention and a prefilled syringe using the syringe assembly equipped with the outer cylinder seal cap will be described with reference to the embodiments shown in the drawings.
As shown in FIGS. 1 to 3, the prefilled syringe 1 of the present invention is housed in the syringe assembly 10 and the syringe assembly 10 and can be slid in a liquid-tight manner in the syringe assembly 10. It consists of a gasket 4, a syringe assembly 10, and a medicine 11 filled in a space formed by the gasket 4.

The syringe assembly (in other words, the outer cylinder with a puncture needle to which the cap is attached) 10 of the present invention includes an outer cylinder 2 and a cap attached to the outer cylinder 2 as shown in FIGS. It consists of three.
The outer cylinder 2 has an outer cylinder main body 21, a cylinder tip 22 provided at the distal end of the outer cylinder main body 21, and a puncture needle tip 61 at the distal end, and a proximal end is inserted into the cylinder tip 22. And a fixed puncture needle 6.

As shown in FIGS. 4 to 15, the cap 3 is housed in a closed distal end portion 71 a, an opening proximal end portion 72, a hollow portion 70 having a puncture needle housing portion for housing the puncture needle 6, and a puncture needle housing portion. A seal cap 7 provided with a pierceable portion 73 into which the puncture needle tip 61 of the puncture needle 6 can be inserted, and a seal portion 75 that seals the puncture needle storage portion by being in close contact with the tube tip portion; 7 is formed of a cylindrical encapsulating member 8 which is mounted on the outside of 7 and engaged with the seal cap 7.
The seal cap 7 is made of an elastic material and has water vapor permeability (in other words, sterilization vapor permeability) for high-pressure steam sterilization (autoclave sterilization). The cylindrical envelope member 8 is made of a thermoplastic material that is harder than the seal cap 7. The cap 3 is configured to increase the engagement force between the cylindrical envelope member 8 and the seal cap 7 by sterilizing the syringe assembly 10 by high-pressure steam sterilization than before sterilization.

  As shown in FIGS. 1 to 3, the prefilled syringe 1 includes a syringe assembly 10 including an outer cylinder 2 and a cap 3 attached to the outer cylinder 2 so as to seal the needle tip of the puncture needle, and a syringe. A gasket 4 housed in the assembly 10 and slidable liquid-tightly in the syringe assembly 10, and a medicine 11 filled in a space formed by the syringe assembly 10 and the gasket 4, It consists of a plunger 5 attached to the gasket 4 or attached at the time of use.

The medicine 11 is filled in a space formed by the outer cylinder 2, the gasket 4, and the cap 3.
The drug 11 to be filled may be any one, for example, high-concentration sodium chloride injection, minerals, heparin sodium aqueous solution, nitroglycerin, isosorbide nitrate, cyclosporine, benzodiazepine, antibiotics, vitamins ( Multivitamin preparations), various amino acids, antithrombotic agents such as heparin, insulin, antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, ulcer treatment agents, corticosteroid agents, arrhythmia agents, correction Any electrolyte, antiviral agent, immunostimulant, etc. may be used.

  As shown in FIGS. 1 to 4, 16, and 17, the outer cylinder 2 includes an outer cylinder main body 21 and a cylindrical (hollow) cylinder tip 22 provided at the tip of the outer cylinder main body 21. And a flange 23 provided at a proximal end portion of the outer cylinder main body portion 21 and a puncture needle 6 having the proximal end portion inserted into the tubular distal end portion 22 and fixed thereto. The puncture needle 6 has a puncture needle tip 61 at the tip. The proximal end portion of the puncture needle 6 is inserted and fixed in the hollow portion of the tube tip portion 22, and the inside of the puncture needle 6 communicates with the internal space 20 of the outer tube 2. The puncture needle 6 may be inserted into a hollow portion of the tube tip portion 22 of the outer tube 2 formed in advance and fixed to the tube tip portion 22 with an adhesive, heat welding, or the like. Alternatively, the puncture needle 6 may be fixed directly to the outer cylinder 2 by insert molding. In the case of insert molding, by molding the outer tube 2, the tube tip portion 22 becomes a tube shape (hollow shape) into which the puncture needle 6 is inserted, and the puncture needle 6 has a base end portion in the hollow portion of the tube tip portion 22. It is inserted into and fixed.

  The outer cylinder 2 is transparent or translucent. The outer cylinder main body 21 is a substantially cylindrical part that accommodates the gasket 4 in a liquid-tight and slidable manner. Further, the tube tip portion 22 protrudes forward from the distal end portion (shoulder portion) of the outer cylinder main body portion, and has a hollow cylindrical shape having a smaller diameter than the outer cylinder main body portion. Further, as shown in FIGS. 4, 16, and 17, the tube tip portion 22 includes a head portion 24 provided at the tip (in this embodiment, an annular head portion having a hollow inside), a head portion 24 is provided at the proximal end, and has a short tapered diameter-reduced portion 25 that is reduced in diameter toward the proximal direction, and a connection that connects the proximal end portion of the tapered reduced-diameter portion 25 and the distal end portion of the outer cylinder main body portion 21. An annular recess is formed by the tapered reduced diameter portion 25. The head portion 24 is formed with a recess 26 that is recessed from the distal end surface toward the proximal end side, and a hollow conical portion that is located in the recess 26 and has a vertex on the distal end side. A plurality of grooves extending in the axial direction of the outer cylinder 2 are formed on the outer surface of the connecting portion 27. Note that the annular recess may have a shape that is not tapered but is simply reduced in diameter so that a step is formed with the base end of the head 24. Further, the connecting portion 27 may be omitted, and the proximal end portion of the annular recess (tapered reduced diameter portion 25) and the distal end portion of the outer cylinder main body portion 21 may be directly connected. The head 24 may have a hollow columnar shape (cylindrical shape) in which the recess 26 and the conical portion are omitted.

Examples of the material for forming the outer cylinder 2 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyesters, cyclic olefin polymers, cyclic olefin copolymers, etc. are mentioned. Among them, polypropylene and cyclic polyolefins (for example, cyclic olefin polymers, cyclic olefin copolymers) are easy to mold and heat resistant. preferable.
As the puncture needle 6, a hollow one having a puncture needle tip 61 at the tip is used. As a material for forming the puncture needle 6, a metal is generally used. Stainless steel is preferred as the metal.

  As shown in FIGS. 1 to 3, the gasket 4 includes a main body portion extending at substantially the same outer diameter, and a plurality of annular ribs provided in the main body portion (in this embodiment, if two, two or more, As long as the liquid-tightness and the slidability can be satisfied, the number may be set as appropriate. Further, the tip surface of the gasket 4 has a shape corresponding to the shape of the inner surface of the distal end of the outer cylinder 2 so as not to form a gap as much as possible between the two when contacting the inner surface of the distal end of the outer cylinder 2.

  The material for forming the gasket 4 includes elastic rubber (eg, isoprene rubber, butyl rubber, latex rubber, silicone rubber), synthetic resin (eg, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene-α olefin copolymer) It is preferable to use an olefin-based elastomer such as a combined elastomer.

  The gasket 4 is provided with a recess extending inward from the base end portion, and this recess has a female screw shape and is formed on the outer surface of the protruding portion 52 formed at the distal end portion of the plunger 5. It can be screwed with the male thread. The plunger 5 is not detached from the gasket 4 by screwing them together. The plunger 5 may be removed and attached at the time of use. Further, the plunger 5 includes a protruding portion 52 that protrudes in a cylindrical shape forward from the disk portion at the tip, and an external thread that is screwed into the recessed portion of the gasket 4 is formed on the outer surface of the protruding portion. The plunger 5 includes a main body 51 extending in the axial direction having a cross-shaped cross section, and a pressing disk 53 provided at the base end.

The cap 3 includes a seal cap 7 and a cylindrical encapsulating member 8 as shown in FIGS.
The cap 3 is a cylindrical tube tip having an outer tube main body portion 21 and a distal end portion of the outer tube main body portion 21 and having a head 24 and an annular recess 25 formed at the base end of the head 24. It is used by being attached to an outer cylinder having a portion 22 and a puncture needle 6 having a puncture needle tip 61 at the distal end and a base end portion inserted and fixed to the tube tip portion 22.

The seal cap 7 includes a closed distal end portion 71a, an opening proximal end portion 72, a hollow portion 70 having a puncture needle storage portion for storing the puncture needle 6, and a puncture needle for the puncture needle 6 stored in the puncture needle storage portion. A pierceable portion 73 into which the tip 61 can be inserted and a seal portion 75 that seals the puncture needle storage portion by being in close contact with the tube tip portion. The cylindrical envelope member 8 is attached to the outside of the seal cap 7 and is engaged with the seal cap 7.
The seal cap 7 is made of an elastic material and has water vapor permeability for high-pressure steam sterilization.

  As a forming material of the seal cap 7, it is necessary that at least the insertable portion 73 is formed of an elastic material into which a puncture needle can be inserted. Examples of elastic materials that can be inserted into a puncture needle and have water vapor permeability for high-pressure steam sterilization include thermoplastic elastomers, for example, styrene elastomers such as SBS elastomers and SEBS elastomers, ethylene-α olefin copolymer Olefin-based elastomers such as coalescence elastomers are preferred. The elastic material may be rubber such as butyl rubber, isoprene rubber, or silicone rubber.

As shown in FIGS. 4 and 13 to 16, the seal cap 7 includes a cylindrical main body 71 and a flange 77 extending in the proximal direction from the proximal end thereof. The cylindrical main body 71 has an outer surface shape that extends in the distal end direction for a predetermined length and that has substantially the same outer diameter or a slightly reduced diameter in the distal end direction. The flange 77 has an outer diameter larger than the outer diameter of the proximal end of the cylindrical main body 71, and extends a predetermined length in the proximal direction with substantially the same outer diameter.
The cylindrical main body 71 includes a closed tip 71a, a seal portion 75 that stores the tip of the tube tip 22, a hollow portion 70 that has a puncture needle storage portion that stores a puncture needle, and a puncture that is stored in the hollow portion 70 The puncture needle tip 61 of the needle 6 includes a pierceable portion 73 into which the needle 6 can be inserted, and a protrusion 76 formed on the inner surface of the seal portion 75. When the seal cap 7 is attached to the tube tip portion 22 of the outer cylinder 2, the puncture needle tip 61 is inserted and sealed in the insertable portion 73 of the seal cap 7, and the protruding portion 76 and the outer tube are sealed. The annular recess 25 of the second tube tip portion 22 is engaged, and the inner surface of the seal portion 75 and the outer surface of the tube tip portion 22 are in close contact with each other, so that the puncture needle storage portion is sealed. The flange 77 has an internal space that accommodates a proximal end portion of the tube tip portion 22, and a proximal end 72 and a proximal end surface 72 a.

  Specifically, the seal cap 7 includes a projecting portion 76 provided on the inner surface located on the distal end side by a predetermined length from the opening base end portion 72. The projecting portion 76 has a most projecting apex portion 76a and an inclined portion (tapered portion) 76b extending from the apex portion 76a in the tip direction and having a projecting height gradually decreasing in the tip direction. In particular, in this embodiment, the projecting portion 76 is an annular projecting portion, and the inclined portion 76b is a tapered portion in which the inner diameter of the seal portion 75 is reduced in the distal direction.

  The inner diameter of the seal portion 75 at the apex portion 76 a is slightly smaller than the outer diameter of the distal end portion of the annular recess 25 of the tube tip portion 22 of the outer tube 2. Thereby, when the seal cap 7 is attached to the tube tip portion 22 of the outer tube 2, the projecting portion 76 and the annular recess 25 are engaged. Further, the tip side inclined portion 76 b extends to the tip side from the annular recess 25 in a state where the seal cap 7 is attached to the tube tip portion 22 of the outer cylinder 2. The inner diameter of the seal portion 75 at least in the vicinity of the proximal end portion of the distal end side inclined portion 76 b is slightly smaller than the outer diameter of the head portion 24 of the tube tip portion 22 of the outer tube 2. As a result, when the seal cap 7 is attached to the tube tip portion 22 of the outer cylinder 2, the distal end side inclined portion 76 b is pressed against the outer surface of the head 24 and is brought into close contact with the outer tube 2. The unintentional detachment of the seal cap 7 is reduced.

In particular, in this embodiment, as shown in FIG. 4, the seal portion 75 of the seal cap 7 is in a state of being spread outward by the tube tip portion 22 of the stored outer tube 2. Specifically, it is elastically deformed and is slightly swollen. For this reason, the distance from the inner surface of the cylindrical enveloping member 8 to be described later is shorter than the other portions, and the inflow of ozone gas under atmospheric pressure at the time of manufacture or the like is restricted.
Further, in the seal cap 7 of this embodiment, the protruding portion 76 is formed in an annular shape along the inner surface of the seal portion 75. For this reason, compared with the case where the protrusion part 76 is intermittently formed in the inner surface of the seal | sticker part 75, the area of the front end side inclination part 76b pressed against the outer surface of the head 24 and closely_contact | adhered becomes large. The unintentional detachment of the seal cap 7 from the toner is further reduced. In addition, the protrusion part 76 may be intermittently formed in the inner surface of the seal part 75.

Further, in the seal cap 7 of this embodiment, the protruding portion 76 further extends from the apex portion 76a toward the opening end (base end) and the protruding height gradually decreases toward the opening end (base end). A proximal-side inclined portion 76c is provided. Accordingly, when the seal cap 7 is attached to the tube tip portion 22 of the outer cylinder 2, the apex portion 76 a of the projecting portion 76 can easily get over the head 24 of the tube tip portion 22 from the distal end side.
In particular, in this embodiment, the protruding portion 76 is an annular protruding portion, and the proximal-side inclined portion 76c is a proximal-side tapered portion in which the inner diameter of the seal portion 75 increases in the proximal direction. ing. In the seal cap 7 of this embodiment, the base end side inclined portion (base end side tapered portion) 76c is shorter and has a larger taper angle than the front end side inclined portion (tip end side tapered portion) 76b. It has become.

  In the seal cap 7 of this embodiment, the seal portion 75 has a predetermined length from the distal end portion of the distal end side inclined portion 76b of the projecting portion 76 toward the distal end direction (specifically, to the proximal end portion of the hollow portion 70). ) It has a linear portion 76d extending. The inner diameter of the seal portion 75 in the straight portion 76d is constant and slightly smaller than the outer diameter of the head portion 24 of the tube tip portion 22 of the outer tube 2. For this reason, when the seal cap 7 is attached to the tube tip portion 22 of the outer tube 2, the linear portion 76 d is pressed against the outer surface of the head 24 and is brought into close contact therewith. The inner diameter of the seal portion 75 in the straight portion 76d may be larger than the outer diameter of the head portion 24 of the tube tip portion 22 of the outer tube 2. Further, the straight portion 76 d may be omitted, and the distal side inclined portion 76 b may be extended to the base end portion of the seal portion 75.

The separation resistance of the seal cap 7 from the outer cylinder 2 is preferably 1.5N to 20N, and particularly preferably 5 to 8N. Thereby, the seal cap 7 can be easily detached from the outer cylinder 2 when the prefilled syringe 1 is used while preventing the seal cap 7 from being unintentionally detached from the outer cylinder 2.
Further, the inclination angle (taper angle) of the tip side inclined portion 76b of the protruding portion 76 of the seal cap 7 is preferably 1 to 10 degrees, and particularly preferably 1 to 6 degrees. Moreover, it is preferable that the protrusion height of the vertex part of the protrusion part 76 is 0.1-0.5 mm, and 0.05-0.25 mm is especially preferable.

  Further, in this embodiment, the base end portion of the tip side inclined portion 76b of the protruding portion 76 of the seal cap 7 is located around the annular recess 25 of the tube tip portion 22 of the outer cylinder 2, and at least the tip side inclined portion 76b. The inner diameter of the seal portion 75 in the vicinity of the base end portion is slightly smaller than the outer diameter of the annular recess 25. In this embodiment, the annular recess 25 of the outer cylinder 2 is provided at the proximal end of the head 24 and is formed of a tapered reduced diameter portion that decreases in diameter toward the proximal direction. As a result, when the seal cap 7 is detached from the outer cylinder 2, the protruding portion 76 of the seal cap 7 is pushed outward along the annular recess 25, so that the head 24 can be easily climbed over.

  And the length in the axial direction of the head 24 of the part which presses and adheres to the outer surface of the head 24 of the front end side inclination part 76b of the protrusion part 76 of the seal cap 7 is 0.1-2.0 mm. Is preferable, and 0.3 to 1.5 mm is particularly preferable. As a result, it is possible to reduce the unintentional detachment of the seal cap 7 from the outer cylinder 2 and to prevent the detachment resistance of the seal cap 7 from the outer cylinder 2 from becoming unnecessarily large.

  Furthermore, the seal cap 7 of this embodiment is provided with a tube tip introduction portion 78 that is formed from the opening base end portion 72 of the seal cap 7 to the base end of the seal portion 75 (projecting portion 76) and extends at substantially the same inner diameter. Yes. The tube tip portion introducing portion 78 has an inner diameter that is slightly wider than the maximum inner diameter of the seal portion 75, and is slightly larger than the outer diameter of the head portion 24 of the tube tip portion 22 of the outer cylinder 2. For this reason, it functions as an introduction portion of the tube tip portion 22 when the seal cap 7 is attached to the tube tip portion 22 of the outer tube 2. Further, the tube tip portion introducing portion 78 has an annular standing surface 79 that stands up toward the opening proximal end portion 72 at the boundary with the proximal end of the seal portion 75 (projecting portion 76).

Therefore, when the distal end portion of the outer cylinder 2 is inserted into the tube tip portion introducing portion 78 of the seal cap 7, the tube tip portion 22 of the outer cylinder 2 enters the tube tip portion introducing portion 78 and then the tube tip portion 22. The annular front end surface of the head 24 comes into contact with the annular standing surface 79, and in this state, the puncture needle 6 becomes substantially parallel to the central axis of the seal cap 7 and enters the hollow portion 70. It becomes a state to do.
Further, in the seal cap 7 of this embodiment, the tube tip portion 22 of the outer tube 2 is inserted into the seal cap, and the annular front end surface of the head portion 24 of the tube tip portion 22 is connected to the tube tip portion introduction portion 78 of the seal cap 7. The puncture needle tip 61 of the puncture needle 6 is configured to enter the hollow portion 70 and not reach the pierceable portion 73 while being in contact with the annular standing surface 79.

A flange 77 is formed at the base end of the seal cap 7 so as to project outwardly in an annular shape. The front end side position of the flange 77 is positioned on the front end side from the annular upstanding surface 79 of the hollow portion 70, and the vicinity of the apex portion 76a of the projecting portion 76 (in the case shown in FIGS. It is located on the end opening 72 side).
The opening base end portion 72 of the seal cap 7 includes an annular base end surface 72a, and a plurality of protrusions 74 are provided on the base end surface 72a. And this base end surface 72a forms the engaging part by the side of the seal cap in engagement with the cylindrical envelope member 8. The proximal end surface 72 a is also the proximal end surface of the flange 77. Therefore, it can also be said that the cap side engaging portion is constituted by the base end face 72 a and the flange 77. The base end surface of the flange 77 may be provided on the front end side with respect to the opening base end portion 72. In this case, the cap side engaging portion is configured not by the base end surface 72 a but by the base end surface of the flange 77.

Next, the cylindrical enveloping member 8 will be described with reference to FIGS.
The cylindrical envelope member 8 is made of a thermoplastic material harder than the seal cap 7, and the engaging force between the cylindrical envelope member 8 and the seal cap 7 is obtained by high-pressure steam sterilization of the syringe assembly 10. Is higher than before sterilization.
As shown in FIGS. 4 to 12, the cylindrical envelope member 8 is a cylindrical body having a seal cap storage portion 80 inside. The cylindrical encapsulating member 8 of this embodiment includes a side surface encapsulating portion 81 that covers the side surface of the seal cap 7 and a front end encapsulating portion 82 that covers the closed front end portion of the seal cap 7.

  The cylindrical enveloping member 8 includes an engagement mechanism for restricting detachment configured in cooperation with the seal cap 7. In this embodiment, the cylindrical envelope member 8 has an internal protrusion provided on the inner surface of the cylindrical envelope member 8 in order to engage with the seal cap 7. Then, the internal projecting portion is displaced inward by the heat of high-pressure steam sterilization, so that the engagement force between the cylindrical enveloping member 8 and the seal cap 7 is increased as compared with that before sterilization. The internal projecting portion extends obliquely from the inner surface of the cylindrical envelope member 8 in the direction of the central axis and the distal end of the cylindrical envelope member 8 and is elastically deformable. When the cylindrical encapsulating member 8 is attached to the seal cap 7, the inner protruding portion is pushed by the outer surface of the seal cap and elastically deforms in a direction away from the central axis of the cylindrical encapsulating member 8. The member 8 can be easily attached to the seal cap 7. Further, when the cap 3 is removed from the outer cylinder 2, the tip of the inner protruding portion is pushed by the seal cap 7 and deforms in a direction close to the central axis of the cylindrical envelope member 8, so that the cylindrical envelope member 8 is It is difficult to remove from the seal cap 7. Further, a plurality of internal projecting portions are provided intermittently around the central axis of the cylindrical envelope member 8. Specifically, the cylindrical encapsulating member 8 of this embodiment includes a plurality of internal protrusions 85 (85a, 85b) provided on the inner surface of the base end portion of the side enveloping portion 81. In particular, in the illustrated example, the cylindrical envelope member extends obliquely from the inside of the base end portion (substantially the base end) of the side surface envelope portion 81 toward the central axis direction and the distal end direction of the cylindrical envelope member 8. 8 is provided with a plurality of elastically deformable internal protrusions 85a and 85b having free ends at positions that do not reach the center. And the free end of each internal protrusion part 85 (85a, 85b) can contact | abut to the base end surface 72a of the seal cap 7, or the protrusion 74. FIG.

  And as shown in FIG. 11, the width | variety of the four internal protrusion parts 85a provided is narrowed toward the free end. In particular, the inner protrusion 85a is narrowed toward the free end because one side surface is inclined. Moreover, the two internal protrusions 85a and 85b provided so as to face each other have the same width and extend to the free end. The inner surfaces of the free ends of the internal projecting portions 85 a and 85 b of the cylindrical envelope member 8 are preferably arcuate surfaces that are substantially centered on the central axis of the cylindrical envelope member 8. In this embodiment, the free ends of the internal protrusions 85a and 85b have a certain arc length, and can reliably come into contact with the base end surface 72a or the protrusion 74 of the seal cap 7. Yes.

  Further, when the cylindrical envelope member 8 is attached to the seal cap 7, the free ends of the internal projecting portions 85 a and 85 b are deformed in a direction away from the central axis of the cylindrical envelope member. Further, when the cylindrical enveloping member 8 moves in the direction of detaching from the seal cap 7, the free ends of the internal projecting portions 85 a and 85 b are deformed in a direction approaching the central axis of the cylindrical enveloping member. Furthermore, in the cylindrical enveloping member 8 of this embodiment, the surfaces on the rear end side of the plurality of internal projecting portions 85a and 85b of the cylindrical encapsulating member 8 are smooth and inclined surfaces facing the central direction of the cylindrical encapsulating member. The guide portion for guiding the seal cap 7 is formed. Moreover, in the cylindrical enveloping member 8 of this embodiment, the surfaces on the front end side of the plurality of internal projecting portions 85a and 85b of the cylindrical enveloping member 8 are also smooth and inclined surfaces toward the central direction of the cylindrical encapsulating member. It has become. Furthermore, each internal protrusion part 85a, 85b is thin toward the free end, and the elastic deformability becomes high toward the free end.

  And the outer diameter in the largest outer diameter part (flange) of the seal cap 7 is 0.5-5 mm from the diameter of the circle which the inner surface of the free end of each internal protrusion part 85a, 85b of the cylindrical envelope member 8 forms. It is preferable that it is large, and it is particularly preferable that it is 1.5 to 3 mm larger. Moreover, it is preferable that the inner diameter of the base end portion of the side surface covering portion 81, in other words, the inner diameter of the portion of the seal cap 7 that houses the flange 77 is substantially equal to the outer diameter of the flange 77 of the seal cap 7. In particular, it is preferable that the base end portion of the side surface encapsulation portion 81 is in close contact with the flange 77 of the seal cap 7 after high-pressure steam sterilization. In particular, it is preferable that the base end portion of the side surface covering portion 81 is in close contact with and pressed against the flange 77 of the seal cap 7 after high-pressure steam sterilization.

  Furthermore, as shown in FIGS. 7 to 9, the cylindrical enveloping member 8 of this embodiment is provided with an opening 86 extending in the distal direction from the base end of each of the internal protrusions 85a and 85b. Thereby, each internal protrusion part 85a, 85b becomes a thing from which the deformation | transformation to the direction spaced apart from the center axis | shaft of the cylindrical envelope member 8 becomes easier, and the cylindrical envelope member 8 is mounted | worn with the seal cap 7. Easy to do. In this embodiment, the six internal protrusions (specifically, the four internal protrusions 85a and the two internal protrusions 85b) are substantially equiangular with respect to the central axis of the cylindrical envelope member 8. It is arranged to become.

And the cylindrical enveloping member 8 of this Example has the through-hole 84 provided in the front-end | tip part, specifically the front-end | tip encapsulation part 82, as shown in FIG. 4 thru | or FIG. The cap 3 is formed by the inner surface of the cylindrical encapsulating member 8 and the outer surface of the seal cap 7, communicates with the through hole 84, and is the base end portion (in other words, the distal end of the flange) ) Is provided with a vapor guiding gap 32 extending to the upper part. In this embodiment, the steam guiding gap 32 extends from the through hole 84 to the tip of the flange 77 of the seal cap 7. The steam guiding gap 32 is an annular space so as to surround the outer surface of the seal cap 7.
The steam guiding gap 32 communicates with the opening 86 at the base end 32a. Specifically, a part of the base end portion (in other words, the front end side portion of the flange 77) of the cylindrical main body portion 71 of the seal cap 7 is located at the front end portion of the opening 86, and in this portion, the seal cap A gap 32 a is formed on the outer surface of 7 (specifically, the outer surface of the base end portion of the cylindrical main body 71 of the seal cap 7) and the inner surface of the base end portion of the cylindrical enveloping member 8. As a result, the steam guiding gap 32 has a distal end communicating with the through hole 84 and a proximal end communicating with the opening 86. For this reason, the circulation of the sterilization steam is good. Note that the base end 32 a of the vapor guiding gap 32 does not have to communicate with the opening 86. In this case, the circulation of the sterilization steam is ensured by the pressure fluctuation during the high-pressure steam sterilization.

In this embodiment, as shown in FIG. 4, the seal portion 75 of the seal cap 7 is in a state of being spread outward by the tube tip portion 22 of the stored outer tube 2. Specifically, it is elastically deformed and is slightly swollen. For this reason, the steam guide gap in this part is a narrow part 32b having a narrower width than the other parts of the steam guide gap 32, and restricts the inflow of ozone gas under atmospheric pressure such as during manufacturing. Yes.
The width of the steam guiding gap 32 (the distance between the inner surface of the cylindrical enveloping member 8 and the outer surface of the seal cap 7) is preferably 0.1 to 2 mm. If the width of the steam guide gap 32 is smaller than 0.1 mm, the flow of sterilization steam becomes poor. If the width is larger than 2 mm, the cylindrical enveloping member 8 wobbles with respect to the seal cap 7 and the cap 3 is removed. The operability when removing from the cylinder 2 is deteriorated. Further, the narrow portion 32b is preferably 0.1 to 2 mm narrower than the width of the other portion of the steam guiding gap portion 32 (the distance between the inner surface of the cylindrical envelope member 8 and the outer surface of the seal cap 7).

In the cylindrical encapsulating member 8 of this embodiment, the front end encapsulating portion 82 includes a plurality of frames connected to the front end portion of the side surface encapsulating portion 81, and the through hole 84 is between adjacent frames. Is formed. Specifically, the tip encapsulating part 82 is formed between a frame and a plurality of frames that connect the tip middle part 83 having a recess at the center, and the tip middle part 83 and the tip part of the side enveloping part 81. A plurality of through holes 84 are provided. In particular, in this embodiment, the tip encapsulation portion 82 includes six frames 89a and 89b. The frame 89a is thick and the frame 89b is thin. Three frames 89a and 89b are alternately arranged. Further, all the frames 89 a and 89 b are arranged so as to be substantially equiangular with respect to the central axis of the cylindrical enveloping member 8. In this embodiment, the number of through holes is 6, but about 2 to 10 is preferable, and 3 to 8 is particularly preferable. The total area of the through holes in the front end side plan view of the tubular encapsulating member 8 is preferably 3 to 25 mm ^2, in particular, is preferably 5 to 20 mm ^2. If it is such, the front-end | tip part will maintain sufficient intensity | strength, and the vapor | steam for sterilization will also pass favorable.

  Further, in this cylindrical enveloping member 8, in a side view shown in FIG. 7, a corner portion 82 a formed at the boundary between the base ends of the frames 89 a and 89 b and the distal end of the side enveloping portion 81 and facing the distal end direction is provided. I have. The width of the corner portion 82a is preferably 0.2 to 1 mm. By providing such a corner portion 82a, the syringe assembly 10 is inserted into a cylindrical portion 142 of the outer cylinder holding member 104, which will be described later, or a hole in a centering plate used for filling a chemical solution, while ensuring the size of the through hole. It will be easy. Further, as shown in the drawing, the cylindrical enveloping member 8 includes a large number of anti-slip ribs 87 formed on the outer surface.

  In the cap 3 of this embodiment, as shown in FIGS. 4 and 6, the cylindrical enveloping member 8 has an opposing inner surface 88 that faces the distal end surface of the closing distal end portion 71 a of the seal cap 7, and A gap 31 is formed between the opposing inner surface 88 and the closing tip 71a. For this reason, the circulation of water vapor in the cap is good. Moreover, the condensed water at the time of sterilization becomes difficult to be trapped, and the drying property is improved. In particular, when sterilizing with the tip of the cap 3 facing down, it is effective because condensed water tends to accumulate at the tip. The length of the gap 31, in other words, the distance between the opposed inner surface 88 and the closed tip 71 a is preferably 0.1 to 5 mm, and particularly preferably 0.3 to 2 mm.

  The structural characteristics of the cylindrical envelope member 8 described above are that the syringe assembly (in other words, the outer cylinder with a puncture needle fitted with a cap) 10 is the same as the cylindrical envelope member 8 after high-pressure steam sterilization. Regardless of whether or not the engagement force with the seal cap 7 is increased as compared with that before sterilization, it has an excellent effect. That is, for example, in the cap 3 shown in FIGS. 5 and 6, the cylindrical encapsulating member 8 is engaged with the base end portion (flange 77) of the seal cap 7 at the base end portion, and even before sterilization. It has sufficient engagement force. Further, the cap 3 includes a gap portion 32 formed between the cylindrical encapsulating member 8 and the seal cap 7, and a through hole 84 communicating with the gap portion 32. For this reason, in the case of EOG sterilization, since the ethylene oxide gas circulates from the through hole 84 to the gap portion 32, the gas flowability is good. Further, as described above, since the width of the corner portion formed at the tip of the cylindrical enveloping member is 0.2 to 1 mm, the cylindrical encapsulating member is secured while ensuring the size of the through hole 84. It is easy to insert the syringe assembly into the cylindrical portion or the hole of the centering plate used when filling the chemical solution.

  When the cap is of the type described above, it is preferable that the cylindrical encapsulating member 8 and the seal cap 7 have sufficient engagement force before sterilization. In this case, a sterilization method other than high pressure steam sterilization such as EOG sterilization or radiation sterilization may be used. The seal cap 7 may not have water vapor permeability for high-pressure steam sterilization (sterilization vapor permeability). In the case where EOG sterilization is used, the seal cap 7 having ethylene oxide gas permeability is used.

  As the forming material of the cylindrical enveloping member 8, a material harder than the forming material of the seal cap 7 is used. Examples of the forming material include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, Various resins such as cyclic polyolefin may be mentioned.

  And it is preferable that the cylindrical enveloping member 8 has the heat shrinkability by the heat | fever at the time of high pressure steam sterilization. The cap 3 is thermally contracted by heat during high-pressure steam sterilization. Thereby, the engaging force of the cylindrical enveloping member 8 and the seal cap 7 increases more than before sterilization. In addition, if the form of the cylindrical enveloping member 8 at the time of shaping | molding has the space | gap 32 between the outer surfaces of the part except the flange 77 of the seal cap 7, as shown to FIG. 4 and FIG. Even after steam sterilization (after heating), as shown in FIG. 4, between the inner surface of the cylindrical encapsulating member 8 and the outer surface of the seal cap 7, the through-hole 84 communicates with water vapor during high-pressure steam sterilization. A possible gap 32 is maintained.

  The cylindrical envelope member 8 is preferably attached to the seal cap 7 after the seal cap 7 is attached to the outer cylinder 2. Thus, by attaching only the seal cap first, it can be confirmed whether the puncture needle has stuck straight into the seal cap. If it is inserted at an angle, the seal cap bends so that it can be easily confirmed. However, in the cap equipped with the cylindrical enveloping member, even when the needle is bent and stabbed, the cap does not bend, so that confirmation is difficult. And it is preferable that the assembly 10 for syringes is high-pressure-steam-sterilized.

Next, an embodiment shown in the drawings will be described with reference to FIGS. 18 to 22 for a package body in which a plurality of syringe assemblies of the present invention are stored.
A sterilizable or sterilized prefilled syringe assembly package 100 containing a plurality of syringe assemblies according to the present invention has a container body 102 having an open top surface and shape retention, and is housed in the container body 102. The outer cylinder holding member 104 capable of holding the plurality of syringe assemblies 10 formed, the plurality of syringe assemblies 10 held by the outer cylinder holding member 104, and the upper surface opening of the container body 102 are hermetically sealed. And a peelable sheet-like lid member 103.

The prefilled syringe assembly package 100 of the present invention is a prefilled syringe assembly package that can be sterilized or sterilized. As a sterilization method, high pressure steam sterilization is used.
As shown in FIGS. 18, 19, and 22, the prefilled syringe assembly package 100 of the present invention includes a container body 102, an outer cylinder holding member 104 that can hold a plurality of syringe assemblies 10, and an outer package. The assembly includes a plurality of syringe assemblies 10 held by a cylinder holding member 104, and a sheet-like lid member 103 that hermetically seals the upper surface opening of the container body 102 and can be peeled off. Furthermore, the package 100 includes a ventilation portion provided on the container body 102 or the sheet-like lid member 103 and having a bacteria-impermeable and sterilizing gas flow.

  As shown in FIGS. 18 to 22, the container body 102 has a tray-like shape having a predetermined depth having a certain degree of strength and shape retention, and has a main body 121 and an upper portion of the main body 121. The outer cylinder holding member holding part 126 for holding the peripheral part of the outer cylinder holding member 104 formed and holding the plurality of syringe assemblies 10 is provided, and an annular flange 124 provided in the upper surface opening.

  Further, an annular heat seal convex portion 125 for fixing to the sheet-like lid member 103 is provided on the upper surface of the annular flange 124. An outer cylinder holding member holding portion 126 is formed at a position that is a predetermined long bottom side from the flange 124. In the container body 102 of the first embodiment, the outer cylinder holding member holding part 126 is an annular stepped part, and the peripheral part of the outer cylinder holding member 104 holding a plurality of syringe assemblies 10 is placed thereon. Can be placed.

  The container body 102 preferably has a certain degree of shape retention and rigidity. In order to cope with high-pressure steam sterilization, it is desirable to use a thermoplastic material having heat resistance (120 ° C. or higher). Examples of materials having a certain degree of shape retention, a certain degree of rigidity, heat resistance and thermoplasticity include polyolefins such as polypropylene and polyethylene, vinyl chloride resins, polystyrene / polypropylene resins, polyethylene / ionomers (eg, ethylene-based, styrene). Type, fluorine type) / polyethylene, polyester resin (for example, polyethylene terephthalate, polybutylene terephthalate, amorphous-polyethylene terephthalate), PP / EVOH / PP (laminate), and the like. In this case, the thickness of the container body 102 is preferably about 0.05 to 4.00 mm, and more preferably 1.00 to 2.00 mm.

  As shown in FIGS. 19 and 22, the outer cylinder holding member 104 capable of holding a plurality of syringe assemblies 10 includes a substrate portion 141 and a plurality of cylindrical portions 142 protruding upward from the substrate portion 141. ing. An outer cylinder holding opening 143 is formed in the cylindrical portion 142, and a gripping notch 144 is formed on a side portion of the substrate portion 141. The inner diameters of the cylindrical portion 142 and the outer cylinder holding opening 143 are larger than the outer diameter of the maximum diameter portion of the syringe assembly 10 to be held, and the syringe assembly 10 to be held has a larger inner diameter. The passage of the flange portion 23 is impossible.

  For this reason, as shown in FIG. 22, the syringe assembly 10 penetrates the cylindrical portion 142 and the flange 23 of the syringe assembly 10 is suspended by the outer cylinder holding opening 143. ing. As shown in FIG. 22, the lower end of the syringe assembly 10 held by the outer cylinder holding member 104 (the tip of the seal cap 7) is not in contact with the bottom surface of the container body 102. In other words, the bottom surface of the container body 102 and the lower end of the syringe assembly 10 held by the outer cylinder holding member 104 (the tip of the seal cap 7) are separated from each other and do not hinder the flow of water vapor. It is desirable that the material for forming the outer cylinder holding member 104 also has heat resistance (120 ° C. or higher) in order to cope with high-pressure steam sterilization.

  The sheet-like lid member 103 is preferably a member that is impermeable to microparticles such as bacteria and viruses and is permeable to water vapor for high-pressure steam sterilization. Further, it is preferable that the container body 102 can be heat sealed. As the sheet-like lid member 103, for example, a synthetic resin nonwoven fabric, specifically, a nonwoven fabric made of a synthetic resin material such as polyolefin known as Tyvek (registered trademark), a synthetic resin porous membrane, or the like is suitable. Can be used.

The sheet-like lid member 103 is heat-sealed so that the peripheral portion thereof can be peeled off by a heat-sealing convex portion 125 provided on the annular flange 124 of the container body 102. In the first embodiment, the outer edge of the sheet-like lid member 103 is not heat-sealed to the annular flange 124 of the container body 102, and is easy to peel off. Moreover, the protrusion part 125a provided in the corner | angular part of the convex part 125 for heat seal functions as a peeling start part. The sheet-like lid member 103 preferably has a thickness of about 0.05 to 1.00 mm, and more preferably about 0.10 to 0.50 mm.
In the first embodiment described above, the ventilation portion is provided in the sheet-like lid member 103, but is not limited thereto, and may be provided in the container body 102.

DESCRIPTION OF SYMBOLS 1 Prefilled syringe 2 Outer cylinder 3 Cap 4 Gasket 6 Puncture needle 7 Seal cap 8 Cylindrical enveloping member 10 Syringe assembly

Claims (14)

An outer cylinder main body, a cylinder tip provided at a distal end of the outer cylinder main body, and a puncture needle having a puncture needle tip at the distal end and having a proximal end inserted and fixed to the cylinder tip A syringe assembly comprising: an outer cylinder provided; and a cap attached to the outer cylinder and sealing the puncture needle tip,
The cap includes a closed distal end portion, an opening proximal end portion, a hollow portion having a puncture needle storage portion for storing the puncture needle, and the puncture needle tip of the puncture needle stored in the puncture needle storage portion. A seal cap provided with a pierceable portion capable of being inserted, and a seal portion that seals the puncture needle storage portion by being in close contact with the tube tip portion; and mounted on the outside of the seal cap and engaged with the seal cap A cylindrical enveloping member,
The seal cap is formed of an elastic material and has water vapor permeability for high-pressure steam sterilization, and the cylindrical encapsulating member is made of a thermoplastic material harder than the seal cap, and An assembly for a syringe, characterized in that the autoclave sterilization of the syringe assembly increases the engagement force between the cylindrical encapsulating member and the seal cap as compared to before sterilization. The assembly for a syringe according to claim 1, wherein the cylindrical encapsulating member is deformed by heat at the time of autoclave sterilization, whereby the engagement force is increased as compared with that before sterilization. The cylindrical enveloping member has an internal protrusion provided on the inner surface of the cylindrical enveloping member to engage with the seal cap, and the internal protrusion is inward by heat during autoclave sterilization. 3. The syringe assembly according to claim 1 or 2, wherein the engaging force is increased by being displaced toward the front than before sterilization. 4. The syringe assembly according to claim 3, wherein the inner projecting portion extends obliquely in a central axis direction and a distal end direction of the cylindrical enveloping member and is elastically deformable. The cylindrical envelope member has an internal protrusion provided on an inner surface of the cylindrical envelope member to engage with the seal cap, and the internal protrusion is formed on the cylindrical envelope member. A plurality of intermittently provided around the central axis, and the cylindrical enveloping member includes an opening extending in a distal direction from a base end of each internal protrusion. The assembly for syringe as described. The cylindrical encapsulating member includes a side enveloping portion that covers a side surface of the seal cap, and a tip encapsulating portion that covers a closing tip portion of the seal cap, and the tip encapsulating portion is a blockage of the seal cap. The syringe assembly according to any one of claims 1 to 5, further comprising an opposing inner surface facing the distal end surface of the distal end portion, and a gap formed between the opposing inner surface and the closed distal end portion. The tip encapsulation portion of the cylindrical encapsulation member includes a plurality of frames connected to the distal end portion of the side surface encapsulation portion, and a through hole is formed between the adjacent frames. 7. The syringe assembly according to 6. The syringe according to claim 7, wherein the cylindrical encapsulating member includes a corner portion formed at a boundary portion between a base end of the frame and a distal end of the side enveloping portion in a side view, and facing a distal end direction. Assembly. The cylindrical enveloping member has a through hole provided at a tip portion, and the cap is formed by an inner surface of the cylindrical enveloping member and an outer surface of the seal cap, and communicates with the through hole, The syringe assembly according to any one of claims 1 to 8, further comprising a vapor guide gap extending to a proximal end portion of the puncture needle storage portion of the seal cap. The seal portion of the seal cap is in a state where the tube tip portion is accommodated and is pushed outward by the tip end portion of the accommodated tube tip portion, and the steam guide gap in the seal portion is The assembly for a syringe according to claim 9, wherein the air gap distance is narrower than other portions. The syringe assembly according to any one of claims 1 to 10, wherein the cylindrical envelope member is attached to the seal cap after the seal cap is attached to the outer cylinder. The syringe assembly according to any one of claims 1 to 11, wherein the syringe assembly is sterilized by high-pressure steam. An assembly for a syringe according to any one of claims 1 to 12, a gasket housed in the outer cylinder and capable of sliding in a liquid-tight manner in the outer cylinder, and formed by the outer cylinder and the gasket. A prefilled syringe comprising a medicine filled in a space. A syringe assembly package housing the syringe assembly according to any one of claims 1 to 12,
The packaging body includes a container body having an open top surface and shape retention, an outer cylinder holding member capable of holding the plurality of syringe assemblies, and a plurality of syringes held by the outer cylinder holding member. An assembly, and a sheet-like lid member that hermetically seals and peels off the upper surface opening of the container body, and the packaging body is impermeable to bacteria provided in the container body or the lid member A syringe assembly package comprising a vent having sterilization gas flow and being sterilized under high pressure steam.

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