JP2005319118A - Method of manufacturing cap and prefilled syringe - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a cap permitting the sufficient sterilization of a syringe to the inside of a mouth of a syringe barrel with the cap attached to the mouth, and capable of maintaining the sterilized state of the syringe after the sterilization. <P>SOLUTION: The cap 6A comprises a connecter 8 fixed to the distal end of the syringe barrel 2, a cap body 7 with an inner cavity part 72, into which the mouth 22 is inserted, to be connected to the connector 8, and a sealing member 9 disposed in the inner cavity part 72, made of an elastic member to seal the distal end opening 225 of the mouth 22 liquid-tightly. When the cap body 7 is connected to the connector 8 fixed to the mouth 22, a gap 61 is formed between the connector 8 and the cap body 7 in the cap 6A, and the state of the cap 6A can be changed to a first state in which the inner cavity part 72 and the outside of the cap body 7 communicate with each other via the gap 61 or to a second state in which the gap 61 is closed to seal the inner cavity part 72 with the sealing member 9 closely attached to the distal end face 222 of the mouth 22. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a method for manufacturing a cap and a prefilled syringe.

  A prefilled syringe in which a liquid preparation is aseptically filled in a sterilized syringe (container) is known.

  Such a prefilled syringe is manufactured as follows, for example. That is, first, sterilization with a high-pressure steam sterilization or a sterilization gas such as hydrogen peroxide is performed on each of the syringe and the cap (sealing member) attached to the liquid discharge part (mouth). Next, in a sterile environment, a cap is attached to the liquid discharge part of the syringe, and then the liquid preparation is filled into the syringe to complete the prefilled syringe.

  However, in such a method, it is necessary to attach a cap to the liquid discharge part of the syringe in an aseptic environment. However, this work space is limited, and it is necessary to attach the cap to the syringe. Since the sterilization process and aseptic maintenance of the apparatus and instruments are complicated, there is a problem that it is difficult to attach the cap to the syringe.

  In order to solve such problems, I: Applying a sterilization treatment with a high-pressure steam sterilization or a sterilization gas such as hydrogen peroxide in a state where a cap is previously attached to the liquid discharge part of the syringe, II: having a breathable filter It is considered effective to sterilize with a sterilizing gas using a cap.

  Incidentally, Patent Document 1 discloses a method of sterilizing a tubular medical device 3 having a sealing portion 31 at one end with a sterilizing gas. However, in such a method, sealing in the medical device 3 is performed. There is a possibility that the sterilization gas does not easily reach the vicinity of the stop portion 31 and the medical device 3 cannot be sufficiently sterilized (the reference is quoted from Patent Document 1).

  In the method I described above, as in Patent Document 1, there is a high possibility that the sterilization gas is difficult to reach the sealed mouth. Furthermore, there is a problem that the sterilization gas does not reach the joint surface between the sealing member and the distal end surface of the mouth.

  On the other hand, in the case of the method II described above, in the case of a container that is stored in a state of storing liquid like a prefilled syringe, the liquid in the container may pass through the filter and leak out.

JP-A-10-179700

  An object of the present invention is to sufficiently sterilize the inside of the mouth portion of the syringe outer cylinder and the joint surface between the sealing member and the tip end surface of the mouth portion, and maintain the sterilized state after the sterilization. It is to provide a cap that can be used. Moreover, it is providing the manufacturing method of the prefilled syringe using this cap.

Such an object is achieved by the present inventions (1) to (6) below. Moreover, it is preferable that it is following (7).
(1) A cap that is formed to protrude from the distal end of the syringe outer cylinder and is attached to a mouth having a diameter smaller than that of the syringe outer cylinder,
A connector fixed to the tip of the syringe outer cylinder;
A cap body having a lumen portion into which the mouth portion is inserted and connectable to the connector;
A sealing member made of an elastic material provided in the lumen of the cap body and capable of liquid-tightly sealing the tip opening of the mouth,
When the cap body is connected to the connector fixed to the mouth portion, a gap is formed between the connector and the cap body, and the lumen portion of the cap body and the outside of the cap body are interposed through the gap. Can be changed between a first state, in which the gap is closed and the lumen portion is sealed, and the sealing member is in close contact with the distal end surface of the mouth portion. Characteristic cap.

  (2) The cap according to (1), wherein the cap body has an opening formed at a tip thereof, and the sealing member is provided so as to close the opening.

(3) A cap that is formed to protrude from the distal end of the syringe outer cylinder and is attached to a mouth that has a diameter smaller than that of the syringe outer cylinder,
A connector fixed to the tip of the syringe outer cylinder;
A cap body having a lumen portion into which the mouth portion is inserted, and an opening portion formed at a tip portion, and connectable to the connector;
A sealing member made of an elastic material provided in the lumen of the cap body and capable of liquid-tightly sealing the tip opening of the mouth;
A lid member attached to the opening of the cap body,
When a cap body with the lid member attached is connected to the connector fixed to the mouth portion, a first gap is formed between the connector and the cap body, and the first gap is interposed between the connector and the cap body. A first state in which a lumen of the cap body communicates with an outside of the cap body, and a second gap is formed between the opening of the cap body and the lid member; And the second gap are closed, the lumen and the opening are sealed, and the sealing member can be changed to a second state where the sealing member is in close contact with the front end surface of the mouth. Cap characterized by that.

  (4) The cap according to any one of (1) to (3), wherein the cap body is moved from the first state to the second state by moving in a proximal direction.

(5) A syringe outer cylinder having a mouth portion protruding from the tip, a cap according to any one of the above (1) to (4) attached to the mouth portion, and the syringe outer cylinder were filled. A method for producing a prefilled syringe comprising a chemical solution,
Sterilizing the cap attached to the mouth as the first state,
Then, in a sterile environment, the cap is changed to the second state,
Then, the said chemical | medical solution is filled in the said syringe outer cylinder in aseptic environment, The manufacturing method of the prefilled syringe characterized by the above-mentioned.

  (6) The said sterilization is a manufacturing method of the prefilled syringe as described in said (5) which is autoclave sterilization.

  (7) The said connector is a cap in any one of said (1) thru | or (4) which has a screwing part screwed together with the outer cylinder side screwing part formed in the said syringe outer cylinder.

According to the present invention, for example, in the production of a prefilled syringe, each part of the syringe outer cylinder can be sufficiently sterilized, and a cap attaching operation can be easily performed.
In particular, the cap mounting operation can be performed in a very small work space such as a sterile room, and furthermore, since there is no need for sterilization treatment or maintenance of sterilization or sterilization of devices and instruments for performing large cap devices, prefilled syringes Workability at the time of manufacturing is improved. As a result, it is possible to reduce the manufacturing time and manufacturing cost of the prefilled syringe.

  Before explaining the manufacturing method of the cap and prefilled syringe of the present invention, the prefilled syringe will be described as an example of the syringe that is used with the cap of the present invention.

  FIG. 12 is a partial cross-sectional view showing the first embodiment of the prefilled syringe, and FIG. 13 is a partial cross-sectional view showing the second embodiment of the prefilled syringe. In the following, for convenience of explanation, the upper side in FIGS. 12 and 13 is referred to as a “tip”, and the lower side is referred to as a “base end”.

<First Embodiment of Prefilled Syringe>
A prefilled syringe (hereinafter simply referred to as “syringe”) 1A shown in FIG. 12 is one in which a drug solution 100 is stored in advance inside the syringe 1A. The syringe 1 </ b> A includes a syringe outer cylinder (outer cylinder) 2, a gasket 3 that can slide in the syringe outer cylinder 2, and a plunger (pusher) 4 that moves the gasket 3.

The syringe outer cylinder 2 is composed of a bottomed cylindrical member having a bottom portion 211.
A plate-like flange 23 is integrally formed on the outer periphery of the proximal end of the syringe outer cylinder 2. When the plunger 4 is moved and operated relative to the syringe outer cylinder 2, the operation can be performed by placing a finger on the flange 23.

A mouth portion 22 having a reduced diameter with respect to the body portion of the syringe outer cylinder 2 is integrally formed at the center portion of the bottom portion 211 (front end) of the syringe outer cylinder 2.
A flow path 221 through which the fluid Q can pass is formed inside the mouth portion 22 and communicates with the lumen portion (space) 24 of the syringe outer cylinder 2.

  On the distal end side of the syringe outer cylinder 2, that is, on the outer peripheral portion on the proximal end side of the mouth portion 22, a male screw (outer cylinder side screwing portion) 223 is formed.

  A mouth portion 22 is inserted into a lumen 72 of the cap body 7 of the cap 6A, which will be described later. Can be attached to the mouth 22 of the syringe outer cylinder 2 (prefilled syringe 1A).

  Moreover, the cap 6B mentioned later can also be mounted | worn with the mouth part 22 of the syringe outer cylinder 2 (prefilled syringe 1A) similarly to the cap 6A.

  As the constituent material of the syringe outer cylinder 2 and the plunger 4 described later, for example, various hard materials, various glass materials, and the like can be used.

  In addition, it is preferable that the constituent material of the syringe outer cylinder 2 is substantially transparent in order to ensure the internal visibility.

  Further, a scale (not shown) is preferably formed on the outer peripheral surface of the outer cylinder 2. Thereby, the liquid quantity of the chemical | medical solution 100 accommodated in 1 A of syringes can be grasped | ascertained.

  In such a syringe outer cylinder 2, a gasket 3 made of an elastic material is accommodated. Two ring-shaped protrusions 31 and 32 are formed on the outer peripheral portion of the gasket 3 at predetermined intervals along the axial direction. By sliding these protrusions 31 and 32 in close contact with the inner peripheral surface 21 of the syringe outer cylinder 2, airtightness (liquid tightness) can be reliably maintained and slidability can be improved.

  Further, the gasket 3 is formed with a hollow portion (not shown) that opens to the base end surface thereof. A head portion (not shown) of the plunger 4 is inserted (inserted) into the hollow portion.

The plunger 4 moves the gasket 3 in the syringe outer cylinder 2 in the longitudinal direction.
The plunger 4 has a main body portion 40 mainly composed of a plate piece having a cross section in a cross section, a plate member 41 at the distal end, and a flange-like (plate-like) finger contact portion 42 at the proximal end. Are integrally formed with the main body 40. The plunger 4 is moved in the distal direction by pressing the finger rest 42 with a finger or the like.

  The cap 6A or 6B of the present invention is detachably attached to the mouth portion 22 of the prefilled syringe 1A (syringe outer cylinder 2) as described above.

<Second Embodiment of Prefilled Syringe>
Next, although 2nd Embodiment of a prefilled syringe is described, it demonstrates centering around difference with 1st Embodiment of the prefilled syringe mentioned above, The description of the same matter is abbreviate | omitted.

  The present embodiment is the same as the first embodiment of the prefilled syringe except that the configuration of the outer cylinder side screwing portion formed on the syringe outer cylinder is different.

  A prefilled syringe (hereinafter simply referred to as “syringe”) 1 </ b> B shown in FIG. 13 is provided with a cylindrical lock adapter (connecting member) 5 on the outer peripheral portion of the mouth portion 22. A female screw 52 is formed on the inner peripheral surface of the lock adapter 5.

  The mouth portion 22 is inserted into the inner cavity 72 of the cap body 7 of the cap 6C, which will be described later, and the male screw 82 of the connector 8C of the cap 6C and the female screw 52 of the lock adapter 5 are screwed together, whereby the syringe outer cylinder The cap 6C of the present invention can be attached to the mouth portion 22 of 2 (prefilled syringe 1B).

  The lock adapter 5 and the syringe outer cylinder 2 (mouth portion 22) are not limited to being formed as separate members, but may be formed integrally, for example.

  Next, the manufacturing method of the cap and prefilled syringe of this invention is demonstrated in detail based on suitable embodiment shown to an accompanying drawing.

<First Embodiment>
First, the cap 6A of the present invention will be described.

  FIG. 1 is a longitudinal sectional view showing a first state (first embodiment) of the cap of the present invention, and FIG. 2 is a longitudinal sectional view showing a second state of the cap shown in FIG. 1, FIG. 3 and FIG. These are the schematic which shows an example of the usage method of the cap shown in FIG. 1, respectively. In the following, for convenience of explanation, the upper side of FIGS. 1 to 4 is referred to as a “tip” and the lower side is referred to as a “base end”.

  A cap 6A shown in FIG. 1 includes a cap body 7, a connector 8, and a sealing member (seal member) 9.

  The cap body 7 is formed of a substantially cylindrical member, and has a lumen 72 formed therein. The lumen member 72 is provided with a sealing member 9.

  As shown in FIGS. 1 and 2, the connector 8 is a syringe in a state where the cap 6A is attached to the syringe 1A (the mouth portion 22 of the syringe outer cylinder 2) (hereinafter, this state is referred to as “cap attached state”). It is fixed to the tip of the outer cylinder 2. The connector 8 is movably connected to a cap body 7 in which a sealing member 9 is provided in the lumen portion 72.

  In the cap mounted state, the cap 6A can be changed between the first state and the second state.

  As shown in FIG. 1, in the cap 6 </ b> A in the first state, a gap (first gap) 61 is formed between the connector 8 and the cap body 7. At this time, the lumen 72 of the cap body 7 and the outside of the cap 6A (cap body 7) communicate with each other through the gap 61. That is, the fluid Q can pass into the mouth portion 22 (flow path 221) through the gap 61.

  As shown in FIG. 2, in the cap 6A in the second state, the gap 61 is closed and the lumen 72 of the cap body 7 is sealed. That is, passage of the fluid Q through the flow path 221 of the lumen portion 72 and the mouth portion 22 is prevented. At the same time, the sealing member 9 comes into close contact with the front end surface 222 of the mouth portion 22 and seals the front end opening 225 of the mouth portion 22 in a liquid-tight manner.

Hereinafter, the configuration of each unit will be described.
The cap main body 7 has a lumen 72 having a cylindrical shape and an opening 73 formed in the tip 75.
In the cap-mounted state, the mouth portion 22 is inserted into the lumen portion 72.

  The opening 73 has a substantially mortar shape and has an opening 731 that opens toward the tip side. A stepped portion 721 having a diameter smaller than the inner diameter of the lumen 72 is formed near the boundary between the lumen 72 and the opening 731. The sealing member 9 is provided so as to contact the stepped portion 721 and close the opening 731 (opening 73). Thereby, for example, as shown in FIG. 3, the syringe main body (double-ended needle) 200 can be connected to the syringe 1A via the cap 6A. This connection will be described in detail in “How to use syringe 1A” described later.

  A plate-like flange 71 is integrally formed on the outer periphery of the base end opening 722 of the cap body 7. In the second state, the flange 71 abuts (adheres) to a distal end face 861 of an outer portion 86 of the connector 8 described later (see FIG. 2). Thereby, the lumen portion 72 of the cap body 7 can be reliably sealed.

  Further, the flange 71 is provided with a plurality of claw portions 74 that are formed to protrude toward the base end side. These claw portions 74 are arranged at equal intervals along the circumferential direction of the base end opening 722. Further, each claw portion 74 engages with a claw portion 83 of the connector 8 to be described later in the second state (see FIG. 2).

  The connector 8 has a substantially cylindrical inner part (inner cylinder) 85 and a substantially cylindrical outer part (outer cylinder) 86 provided concentrically on the outer peripheral side of the inner part 85.

  On the inner periphery of the inner portion 85, a female screw 81 that is screwed into the male screw 223 of the syringe outer cylinder 2 is formed. Thereby, the connector 8 (cap 6A) can be easily attached and detached with the syringe outer cylinder 2.

  In the first state, the side surfaces of the claw portions 74 of the cap body 7 are in contact with the outer periphery of the inner portion 85. As a result, the cap body 7 can be supported so as to maintain the state in which the gap 61 is formed between the cap body 7 and the connector 8, that is, the first state.

  Further, the cap 6A in the first state changes to the second state while the side surfaces of the claw portions 74 slide in the proximal direction on the outer periphery of the inner portion 85. Thus, by moving (pressing) the cap body 7 in the proximal direction, the cap 6A can be easily changed from the first state to the second state.

  A tapered surface 851 having an inner diameter that gradually decreases toward the tip is formed at the tip of the inner periphery of the inner portion 85. The taper surface 851 is fitted to the taper surface 224 formed in the mouth portion 22 of the syringe outer cylinder 2 in the cap mounted state. Thereby, the connector 8 (cap 6A) is securely fixed (attached) by the mouth portion 22.

  A plurality of claw portions 83 corresponding to the plurality of claw portions 74 of the cap body 7 are formed on the inner periphery of the outer side portion 86. In the second state, the claws 74 and 83 are engaged with each other. As a result, the flange 71 can be reliably brought into contact with the distal end face 861 of the outer portion 86 of the connector 8, and thus the lumen portion 72 of the cap body 7 can be more reliably sealed. Further, the cap 6A is reliably prevented from changing from the second state to the first state. That is, the cap body 7 can move only in one direction (irreversibly).

  The sealing member 9 is a disk-shaped member made of an elastic material. The sealing member 9 liquid-tightly seals the tip opening 225 of the mouth portion 22 in the second state (see FIG. 2). Thereby, the chemical | medical solution 100 with which the syringe outer cylinder 2 was filled can prevent leaking from the front-end | tip opening 225. FIG.

  The elastic material constituting the sealing member 9 is not particularly limited. For example, natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic rubber, ethylene-propylene rubber , Various rubber materials such as hydrin rubber, urethane rubber, silicone rubber, fluorine rubber (especially those vulcanized), styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, Examples include various thermoplastic elastomers such as transpolyisoprene, fluororubber, and chlorinated polyethylene, and relatively flexible resin materials such as polyethylene and vinyl chloride resin. It can be used by mixing.

  Further, the constituent materials of the cap body 7 and the connector 8 are not particularly limited. For example, polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, Acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, polyethylene naphthalate, butadiene-styrene copolymer, polyamide (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12), ethylene-vinyl Various resins such as alcohol copolymer, polyallylsulfone, polyethersulfone, methacryl-styrene copolymer, polyarylate, styrene-acrylonitrile copolymer can be mentioned. In terms of easy, polypropylene, cyclic polyolefins, polyesters, poly - (4-methylpentene-1) resin such as is preferred.

  Next, a manufacturing method (assembly method) of the prefilled syringe 1A using the cap 6A will be described.

  [1] First, the syringe outer cylinder 2 and the cap 6A are prepared, and the cap 6A is attached to the mouth portion 22 of the syringe outer cylinder 2. At this time, the cap 6A is kept in the first state (see FIG. 1).

[2] In this state, the syringe barrel 2 is placed in an autoclave sterilizer. Thereafter, high-pressure steam R is supplied into the apparatus for sterilization.
At this time, a gap 61 through which the high-pressure steam R passes is formed in the cap 6A. As a result, the high-pressure steam R sequentially passes through the gap 61 and the inner cavity 72 of the cap body 7 and is sufficiently sterilized in the syringe outer cylinder 2, particularly in the mouth 22 (flow path 221).

[3] Next, after the completion of sterilization, the syringe outer cylinder 2 is moved into an isolator in an aseptic environment. Thereafter, the cap body 7 is pressed in the proximal direction by a pressing machine (not shown) to change the cap 6A to the second state (see FIG. 2).
At this time, as described above, the claw portion 74 of the cap body 7 and the claw portion 83 of the connector 8 are engaged. Thereby, the cap 6A can be maintained in the second state. Therefore, the sterilized state in [2] can be maintained.

  Further, the cap 6A of the present invention can change the cap 6A from the first state to the second state by a simple operation such as a pressing operation. The instrument can reliably perform the operation.

  [4] Thereafter, in a sterile environment, the syringe 100 is filled with the chemical solution 100 that has been previously sterilized (for example, filtration sterilization) from the opening at the proximal end of the syringe outer cylinder 2. This filling amount corresponds to the capacity of the syringe 1A and is about 0.1 to 100 mL. After filling the chemical solution 100, the gasket 3 and the plunger 4 are attached to complete the syringe 1A.

  Moreover, in this state, since the mouth part 22 (flow path 221) of the syringe outer cylinder 2 is sealed in an airtight (liquid-tight) manner by the sealing member 9, the drug solution 100 leaks from the syringe 1A. Is prevented.

  Further, the drug solution 100 is not particularly limited, and examples thereof include electrolyte correction injection solutions such as sodium chloride and potassium lactate, vitamin agents, vaccines, antibiotic injection solutions, steroid agents, proteolytic enzyme inhibitors, fat emulsions, various emulsions, and the like. Examples include protein preparations, anticancer agents, anesthetics, stimulants, various drug solutions such as narcotics, various diagnostic agents, and the like.

  The sterilization of the syringe outer cylinder 2 is not limited to autoclave sterilization. For example, gas sterilization using a sterilizing gas such as hydrogen peroxide or EOG, radiation sterilization by irradiation with γ rays, or the like may be used. it can.

Next, a specific example of how to use the syringe 1A provided with the cap 6A will be described.
[Specific Example 1]
First, as shown to Fig.3 (a), the syringe main body 200 and the syringe 1A with which the cap 6A was equipped are prepared.

  Here, the syringe body 200 will be described (for example, see Japanese Patent Application Laid-Open No. 2000-42106). The syringe body 200 has a cylindrical outer cylinder 201 (generally called a holder or an adapter) having a bottom 201a on the distal end side. A double-ended needle having a first needle tube 202 and a second needle tube 203 is attached to the bottom 201a of the outer cylinder 201, and the first needle tube 202 protrudes from the bottom 201a to the outside (tip side) of the outer cylinder 201. ing. Further, the needle tip of the second needle tube 203 faces in the opposite direction to the needle tip of the first needle tube 202.

  An encapsulation member 204 that encapsulates at least the needle tip of the second needle tube 203 is installed around the second needle tube 203. The envelope member 204 serves to prevent contamination of the needle tip of the second needle tube 203 when not in use. The encapsulating member 204 is composed of a film made of various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, silicone rubber, and latex rubber, and is easily formed by the needle tip of the second needle tube 203. Those that can be pierced are preferably used.

  Next, as shown in FIG. 3B, the syringe body 200 is inserted into the opening 73 of the cap 6A (cap body 7) from the second needle tube 203 side, and the syringe body 200 is further moved to the proximal end side. Moving. Accordingly, the needle tip of the second needle tube 203 is inserted into the flow path 221 of the syringe outer cylinder 2 through the encapsulating member 204 and the sealing member 9 sequentially. Thereby, the syringe main body 200 is connected to the syringe 1A. Until this connection is made, the flow path 221 of the syringe 1A is maintained in a sterilized state.

  Thus, by using the cap 6A, the syringe body 200 can be connected to the syringe 1A with a simple operation and while maintaining the sterilized state of the flow path 221 of the syringe 1A.

[Specific Example 2]
First, as shown in FIG. 4A, the cap 6A is rotated counterclockwise with respect to the syringe 1A, and the cap 6A (connector 8) and the syringe 1A (syringe outer cylinder 2) are screwed (fixed). ).

  Next, as shown in FIGS. 4B and 4C, the cap 6A is moved in the distal direction, and the cap 6A is removed from the syringe 1A. Until this operation is performed, the flow path 221 of the syringe 1A is maintained in a sterilized state.

  Next, for example, a connector (connector) 300 having at least one male luer lock portion (female side connection port) 301 is prepared (for example, see Japanese Patent Application Laid-Open No. 2003-144546). Then, as shown in FIG. 4D, the mouth portion 22 of the syringe 1A is connected (fitted) to the male luer lock portion 301 of the connector 300. Thereby, the chemical | medical solution 100 in 1 A of syringes can be made to flow out through the connection tool 300 to the tube (not shown) connected to the connection tool 300, for example.

  As described above, by using the cap 6A, the connector 300 can be connected to the syringe 1A with a simple operation and while maintaining the sterilized state of the flow path 221 of the syringe 1A.

Second Embodiment
FIG. 5 is a longitudinal sectional view showing a first state (second embodiment) of the cap of the present invention, FIG. 6 is a longitudinal sectional view showing a second state of the cap shown in FIG. 5, and FIG. 5 is an enlarged detailed view of a region [A] surrounded by a two-dot chain line in FIG. 5, FIG. 8 is an enlarged detailed view of a region [A] surrounded by a two-dot chain line in FIG. 6, and FIGS. It is the schematic which shows an example of the usage method of the cap shown in FIG. 5, respectively. In the following, for convenience of explanation, the upper side of FIGS. 5 to 10 is referred to as a “tip” and the lower side is referred to as a “base end”.

  Hereinafter, the second embodiment of the cap of the present invention will be described with reference to these drawings. However, the difference from the above-described first embodiment will be mainly described, and the description of the same matters will be omitted.

  The second embodiment is the same as the first embodiment except that the cap includes a lid member.

  As shown in FIG. 5, the lid member 10 provided in the cap 6 </ b> B is a member attached to the opening 73 of the cap body 7.

As shown in FIGS. 5 and 6, the connector 8 is a syringe in a state where the cap 6B is attached to the syringe 1A (the mouth portion 22 of the syringe outer cylinder 2) (hereinafter, this state is referred to as a “cap attached state”). It is fixed to the tip of the outer cylinder 2. In addition, a cap body 7 provided with a sealing member 9 and a lid member 10 is movably connected to the connector 8.
In the cap mounting state, the cap 6B can be changed between the first state and the second state.

  As shown in FIG. 5, in the cap 6 </ b> B in the first state, a first gap (gap) 61 is formed between the connector 8 and the cap body 7. At this time, the lumen 72 of the cap body 7 and the outside of the cap 6B (cap body 7) communicate with each other via the first gap 61. That is, the fluid Q can pass into the mouth portion 22 (flow path 221) through the first gap 61.

  In the cap 6 </ b> B in the first state, a second gap 62 is formed between the opening 73 of the cap body 7 and the lid member 10. At this time, the opening 731 of the cap body 7 communicates with the outside of the cap 6B through the second gap 62 and the hollow portion 103 of the lid member 10. That is, the fluid Q can pass through the opening 731 through the second gap 62 and the hollow portion 103.

  As shown in FIG. 6, in the cap 6B in the second state, the first gap 61 is closed and the lumen 72 of the cap body 7 is sealed. That is, passage of the fluid Q through the flow path 221 of the lumen portion 72 and the mouth portion 22 is prevented.

  In the cap 6B in the second state, the second gap 62 is closed and the opening 731 (opening 73) is sealed. That is, passage of the fluid Q to the opening 731 is prevented.

  Further, along with these sealings, the sealing member 9 comes into close contact with the distal end surface 222 of the mouth portion 22 to seal the distal end opening 225 of the mouth portion 22 in a liquid-tight manner.

Hereinafter, the lid member 10 will be described.
The lid member 10 includes a lid main body 101 and a collar portion 102.
The lid body 101 has a bottomed cylindrical shape, and a hollow portion 103 is formed. As shown in FIGS. 7 and 8, a plurality of convex portions 104 projecting toward the central axis of the lid body 101 are formed on the proximal end side of the inner peripheral surface 106 of the hollow portion 103. These convex portions 104 are arranged at equal intervals along the circumferential direction of the inner peripheral surface 106.

  In the first state, each convex portion 104 abuts on the outer peripheral surface 76 of the cap body 7. As a result, a second gap 62 is generated between the inner peripheral surface 106 and the outer peripheral surface 76 (see FIG. 7). Further, in the second state, each convex portion 104 enters a ring-shaped concave portion 761 formed on the outer peripheral surface 76 of the cap body 7. Thereby, the inner peripheral surface 106 and the outer peripheral surface 76 are brought into close contact with each other, and the second gap 62 is closed (see FIG. 8).

  In addition, a convex portion 105 that protrudes toward the proximal end is formed at the center of the bottom portion of the lid main body 101. The convex portion 105 has a shape corresponding to the shape of the opening 731 of the cap body 7. As shown in FIG. 5, in the second state, the convex portion 105 fits into the opening 731 and seals the opening 731.

  The collar portion 102 has a substantially plate shape and is formed to protrude from the outer peripheral surface 107 of the lid body 101. When removing the lid member 10 from the cap 6B, the collar portion 102 is pulled toward the distal end side while holding the collar portion 102 therebetween. Thereby, the lid member 10 can be easily removed from the cap 6B.

  The constituent material of the lid main body 101 is not particularly limited, and for example, the materials mentioned for the sealing member 9 can be used.

Next, a manufacturing method (assembly method) of the prefilled syringe 1A using the cap 6B will be described.
[1] First, the syringe outer cylinder 2 and the cap 6B are prepared, and the cap 6B is attached to the mouth portion 22 of the syringe outer cylinder 2. At this time, the cap 6B is kept in the first state (see FIG. 5).

[2] In this state, the syringe barrel 2 is placed in an autoclave sterilizer. Thereafter, high-pressure steam R is supplied into the apparatus for sterilization.
At this time, a first gap 61 through which the high-pressure steam R passes is formed in the cap 6B. As a result, the high-pressure steam R sequentially passes through the first gap 61 and the lumen 72 of the cap body 7 and is sufficiently sterilized in the syringe outer cylinder 2, in particular, in the mouth 22 (channel 221). .

  The cap 6B is formed with a second gap 62 through which the high-pressure steam R passes. As a result, the high-pressure steam R passes through the second gap 62 and the hollow portion 103 of the lid body 101 in order, and is sufficiently sterilized to the opening 731 and the sealing member 9 exposed from the opening 731 of the cap body 7.

  [3] Next, after the completion of sterilization, the syringe outer cylinder 2 is moved into an isolator in an aseptic environment. Thereafter, the cap body 7 and the lid member 10 are pressed in the proximal direction by a pressing machine (not shown) to change the cap 6B to the second state (see FIG. 6). Thereby, the sterilization state in said [2] is maintainable.

  [4] Thereafter, in a sterile environment, the syringe 100 is filled with the chemical solution 100 that has been previously sterilized (for example, filtration sterilization) from the opening at the proximal end of the syringe outer cylinder 2. This filling amount corresponds to the capacity of the syringe 1A and is about 0.1 to 100 mL. After filling the chemical solution 100, the gasket 3 and the plunger 4 are attached to complete the syringe 1A.

Next, the specific example of the usage method of syringe 1A provided with the cap 6B is demonstrated.
[Specific Example 1]
First, a syringe main body 200 and a syringe 1A to which a cap 6B is attached are prepared.

  Next, as shown in FIG. 9A, the lid member 10 is removed. In the cap 6B, the sterilized state in the opening 73 is maintained until this operation is performed.

  Next, as shown in FIGS. 9B and 9C, the syringe main body 200 is inserted into the opening 73 of the cap 6B (cap main body 7) from the second needle tube 203 side. Move to the proximal side. Accordingly, the needle tip of the second needle tube 203 is inserted into the flow path 221 of the syringe outer cylinder 2 through the encapsulating member 204 and the sealing member 9 sequentially. Thereby, the syringe main body 200 is connected to the syringe 1A. When this connection is made, since the sterilized state of the opening 73 is maintained as described above, the second needle tube 203 of the syringe body 200 is prevented from being contaminated by the opening 73. Moreover, until this connection is made, the flow path 221 of the syringe 1A is maintained in a sterilized state.

  Thus, by using the cap 6B, the syringe body 200 can be connected to the syringe 1A with a simple operation and while maintaining the sterilized state of the flow path 221 and the opening 73 of the syringe 1A.

[Specific Example 2]
First, as shown in FIG. 10A, the cap 6B is rotated counterclockwise with respect to the syringe 1A, and the cap 6B (connector 8) and the syringe 1A (syringe outer cylinder 2) are screwed (fixed). ).

  Next, as shown in FIGS. 10B and 10C, the cap 6B is moved in the distal direction, and the cap 6B is removed from the syringe 1A. Until this operation is performed, the flow path 221 of the syringe 1A is maintained in a sterilized state.

  Next, for example, a connector (connector) 300 having at least one male luer lock part (female side connection port) 301 is prepared. Then, as shown in FIG. 10 (d), the mouth portion 22 of the syringe 1 </ b> A is connected (fitted) to the male luer lock portion 301 of the connector 300. Thereby, the chemical | medical solution 100 in 1 A of syringes can be made to flow out through the connection tool 300 to the tube (not shown) connected to the connection tool 300, for example.

  Thus, by using the cap 6B, the connection tool 300 can be connected to the syringe 1A with a simple operation and while maintaining the sterilized state of the flow path 221 of the syringe 1A.

<Third Embodiment>
FIG. 11 is a longitudinal sectional view showing a first state (third embodiment) of the cap of the present invention. In the following, for convenience of explanation, the upper side of FIG. 11 is referred to as “tip” and the lower side is referred to as “base end”.

  Hereinafter, the third embodiment of the cap of the present invention will be described with reference to this figure, but the description will focus on the differences from the first embodiment described above, and the description of the same matters will be omitted.

  The third embodiment is the same as the first embodiment except that the shape of the connector is different.

  As shown in FIG. 11, in the connector 8 </ b> C included in the cap 6 </ b> C, the inner portion 85 protrudes to the proximal end side from the outer portion 86. That is, the connector 8 </ b> C is formed such that the length of the inner portion 85 (vertical direction in FIG. 11) is longer than the length of the outer portion 86.

  The inner portion 85 has a male screw 82 formed on the outer periphery of the base end portion. In the cap mounted state, the male screw 82 is screwed into a female screw 52 formed on the inner surface of the lock adapter 5 of the syringe 1B. Thereby, cap 6C can be detachably attached to syringe 1B.

  As described above, even when the cap having the configuration described in the third embodiment is used, the prefilled syringe 1B can be manufactured in the same manner as in the first embodiment. Moreover, the prefilled syringe 1B can be used similarly to 1st Embodiment.

  As mentioned above, although the manufacturing method of the cap of the present invention and the prefilled syringe has been described with respect to the illustrated embodiment, the present invention is not limited to this, and each part constituting the cap can be any one that can exhibit the same function. It can be replaced with the configuration of Moreover, arbitrary components may be added.

In the cap of the present invention, any two or more configurations (features) of the first to third embodiments may be combined.
For example, the cap of the second embodiment may be provided on the cap of the third embodiment. Moreover, the connector of the cap of the second embodiment may be configured to have a male screw like the connector of the cap of the third embodiment.

  Moreover, the attachment method with respect to the opening | mouth part of a cap is not limited to the method by screwing, For example, what kind of methods, such as a fitting, crimping, ultrasonic welding, laser welding, may be sufficient.

  Further, when attaching the cap to the mouth portion, it is not limited to attaching the cap to the mouth portion in a state where the cap body and the connector are connected in advance. For example, the connector is first fixed to the syringe outer cylinder and then to the connector. The cap may be attached to the mouth so that the cap body is connected.

It is a longitudinal cross-sectional view which shows the 1st state (1st Embodiment) of the cap of this invention. It is a longitudinal cross-sectional view which shows the 2nd state of the cap shown in FIG. It is the schematic which shows an example of the usage method of the cap shown in FIG. It is the schematic which shows an example of the usage method of the cap shown in FIG. It is a longitudinal cross-sectional view which shows the 1st state (2nd Embodiment) of the cap of this invention. It is a longitudinal cross-sectional view which shows the 2nd state of the cap shown in FIG. FIG. 6 is an enlarged detail view of a region [A] surrounded by a two-dot chain line in FIG. 5. FIG. 7 is an enlarged detail view of a region [A] surrounded by a two-dot chain line in FIG. 6. It is the schematic which shows an example of the usage method of the cap shown in FIG. It is the schematic which shows an example of the usage method of the cap shown in FIG. It is a longitudinal cross-sectional view which shows the 1st state (3rd Embodiment) of the cap of this invention. It is a fragmentary sectional view showing a 1st embodiment of a prefilled syringe. It is a fragmentary sectional view showing a 2nd embodiment of a prefilled syringe.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1A, 1B Prefilled syringe 2 Syringe outer cylinder 21 Inner peripheral surface 211 Bottom 22 Portion 221 Channel 222 Front end surface 223 Male screw 224 Taper surface 225 End opening 23 Flange 24 Space 3 Gasket 31, 32 Protrusion 4 Plunger 40 Main body 41 Plate member 42 Finger rest 5 Lock adapter 52 Female thread 6A, 6B, 6C Cap 61 Gap (first gap)
62 second gap 7 cap body 71 flange 72 lumen portion 721 stepped portion 722 proximal end opening 73 opening portion 731 opening 74 claw portion 75 distal end portion 76 outer peripheral surface 761 recessed portion 8, 8C connector 81 female screw 82 male screw 83 claw portion 85 Inner portion 851 Tapered surface 86 Outer portion 861 Tip surface 9 Sealing member 10 Lid member 101 Lid main body 102 Collar portion 103 Hollow portion 104, 105 Convex portion 106 Inner peripheral surface 107 Outer peripheral surface 100 Drug solution 200 Syringe main body 201 Outer cylinder 201a Bottom 202 1st needle tube 203 2nd needle tube 204 Encapsulating member 300 Connector 301 Male luer lock part Q Fluid R High pressure steam

Claims (6)

A cap that is formed to protrude at the tip of the syringe outer cylinder and is attached to the mouth that has a diameter smaller than that of the syringe outer cylinder,
A connector fixed to the tip of the syringe outer cylinder;
A cap body having a lumen portion into which the mouth portion is inserted and connectable to the connector;
A sealing member made of an elastic material provided in the lumen of the cap body and capable of liquid-tightly sealing the tip opening of the mouth,
When the cap body is connected to the connector fixed to the mouth portion, a gap is formed between the connector and the cap body, and the lumen portion of the cap body and the outside of the cap body are interposed through the gap. Can be changed between a first state, in which the gap is closed and the lumen portion is sealed, and the sealing member is in close contact with the distal end surface of the mouth portion. Characteristic cap.   The cap according to claim 1, wherein the cap body has an opening formed at a tip thereof, and the sealing member is provided so as to close the opening. A cap that is formed to protrude at the tip of the syringe outer cylinder and is attached to the mouth that has a diameter smaller than that of the syringe outer cylinder,
A connector fixed to the tip of the syringe outer cylinder;
A cap body having a lumen portion into which the mouth portion is inserted, and an opening portion formed at a tip portion, and connectable to the connector;
A sealing member made of an elastic material provided in the lumen of the cap body and capable of liquid-tightly sealing the tip opening of the mouth;
A lid member attached to the opening of the cap body,
When a cap body with the lid member attached is connected to the connector fixed to the mouth portion, a first gap is formed between the connector and the cap body, and the first gap is interposed between the connector and the cap body. A first state in which a lumen of the cap body communicates with an outside of the cap body, and a second gap is formed between the opening of the cap body and the lid member; And the second gap are closed, the lumen and the opening are sealed, and the sealing member can be changed to a second state where the sealing member is in close contact with the front end surface of the mouth. Cap characterized by that.   The cap according to any one of claims 1 to 3, wherein the cap body is moved from the first state to the second state by moving in a proximal direction. A prefilled syringe comprising a syringe outer cylinder having a mouth portion protruding from the tip, a cap according to any one of claims 1 to 4 attached to the mouth portion, and a drug solution filled in the syringe outer tube. A method of manufacturing
Sterilizing the cap attached to the mouth as the first state,
Then, in a sterile environment, the cap is changed to the second state,
Then, the said chemical | medical solution is filled in the said syringe outer cylinder in aseptic environment, The manufacturing method of the prefilled syringe characterized by the above-mentioned.   The method for producing a prefilled syringe according to claim 5, wherein the sterilization is autoclave sterilization.

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