JP2006271938A - Prefilled syringe - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a prefilled syringe which can set the mixture and the discharge sequence of a plurality of ingredients. <P>SOLUTION: The prefilled syringe is equipped with an outer cylinder 12 having a discharge section 11 and a plunger gasket 15 and partition gaskets 16X and 16Y disposed in the outer cylinder, includes a plurality of mixing accommodation chambers 18a and 18b which are provided on the side of the discharge section 11 and accommodate the plurality of ingredients to be mixed in the outer cylinder 12 and to be discharged and an accommodation chamber 19 for the sequential discharge which is provided closer on plunger 14 side than on the plurality of mixing accommodation chambers 18a and 18b and accommodates the ingredient for the sequential discharge which is discharged after the mixed ingredients, and is equipped with a mixing discharge means 30 which communicates between the mixing accommodation chambers 18a and 18b and can mix the plurality of ingredients to be mixed by moving the plunger gasket 15 to the side of the discharge section 11 and a sequential discharge means 20 which can discharge the ingredient for the sequential discharge from the discharge section 11 by moving the plunger gasket 15 to the side of the discharge section 11 after the discharge of the mixed ingredients. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  In the present invention, three or more storage chambers are partitioned by a plurality of partitioning gaskets arranged in the outer cylinder, and a plurality of mixed components discharged and mixed in these storage chambers during use, or dissolved during use. It is related with the prefilled syringe suitable for isolate | separating and accommodating the solid chemical | medical agent and solution which are discharged | emitted by this.

  Conventionally, in the case of injections and infusions for administering multiple components to patients, components that are prone to degradation or alteration at an early stage when mixed are stored separately and mixed immediately before use. For example, it is stored as a solid drug that is stable and easy to store for a long time, and is mixed with a solution or dispersion at the time of use to prepare an injection or infusion. Many are administered to patients.

In order to facilitate the mixing operation at the time of use and prevent mistakes in preparation, the inside of the outer cylinder is divided into a plurality of storage chambers by partition gaskets, and a solid medicine or a chemical solution is stored in one storage chamber. A number of two-chambered prefilled syringes have been proposed in which a solution, a dispersion, other chemicals, and the like are housed in the housing chamber (see, for example, Patent Documents 1 to 4 below).

  These prefilled syringes can be maintained in a state where the two components are isolated during manufacture and storage, and when used, the partition gasket that partitions the plurality of storage chambers can be moved to a predetermined position by pressing the plunger. A flow path is formed to communicate between the storage chambers on both sides of the gasket for use, and a solution, dispersion liquid, chemical solution, or the like in one storage chamber is transferred from the flow path to the other storage chamber and mixed. An injection solution or an infusion solution in which these components are mixed can be prepared. Then, by further pressing the plunger, the prepared mixed liquid can be discharged from the discharge portion.

JP 60-72561 A JP 2001-104482 A JP 2000-60970 A JP-A-8-112358

However, many of the conventional prefilled syringes mix and discharge two components separated and stored in two storage chambers during use, and many of them are difficult to store three or more components. Even if three or more components are accommodated by providing the above-described accommodation chamber, the components can be discharged only in a mixed state during use.
Therefore, when three or more components are used at the time of use, if conditions exist in the mixing order, the discharging order, etc. of the respective components, they cannot be accommodated in one prefilled syringe and simultaneously mixed and discharged.

  For example, when using a poorly soluble solid drug that is difficult to dissolve in a liquid around pH 7 and can be dissolved by an acidic or alkaline liquid, using a conventional prefilled syringe, the pH of the liquid to be discharged is brought to around 7 Since it must be prepared, a solution for injection near pH 7 must be used as a solution for dissolving a solid drug. For this reason, if the components in the respective storage chambers are mixed and dissolved at the time of use, the dissolution operation is difficult, and it takes time and effort to dissolve the syringe. Moreover, if it is dissolved using an acidic or alkaline solution and then prepared using an adjusting solution so that the pH is around 7, a plurality of mixing operations must be performed in order, and the preparation operation is troublesome. Cost. Further, when the operation is performed a plurality of times as described above, preparation errors such as mistakes in the drug components and the amount of use thereof are likely to occur, and problems such as contamination by bacteria occur.

  Therefore, an object of the present invention is to provide a prefilled syringe that is suitable for mixed injection and can set the order of mixing and discharging a plurality of components.

The invention according to claim 1 for solving the above-described problems includes an outer cylinder having a discharge portion, a plunger gasket disposed in a liquid-tight manner in the outer cylinder, the discharge portion in the outer cylinder, and the A prefilled syringe provided with a plurality of partitioning gaskets arranged in a liquid-tight manner between the plunger gasket and partitioning three or more storage chambers,
A plurality of mixing chambers in which the three or more storage chambers are provided adjacent to each other from the discharge portion side and separately store a plurality of mixed components that are mixed and discharged in the outer cylinder. And a sequential discharge storage chamber that is provided closer to the plunger than the plurality of mixing storage chambers and stores a sequential discharge component discharged after the mixing component,
By moving the plunger gasket toward the discharge portion, the mixing components in the mixing chamber on the plunger gasket side are communicated between the mixing chambers to the mixing chamber on the discharge portion side. Mixed discharge means to be transferred;
It is characterized by comprising sequential discharge means capable of discharging the sequential discharge components from the discharge section by moving the plunger gasket to the discharge section side after discharging the mixed components.

According to a second aspect of the present invention, in the first aspect of the present invention, the mixing and discharging means is arranged between the mixing storage chambers when the partition gasket for partitioning the mixing storage chambers reaches a communication area. With a communication path that communicates
The sequential discharge means sequentially discharges when the partitioning gasket disposed between the sequential discharge component and the mixed component after mixing reaches the discharge region on the discharge portion side with respect to the communication region. A road is provided.

  The invention according to claim 3 is the invention according to claim 2, wherein the sequential discharge means is formed in the partition gasket disposed between the sequential discharge component and the mixed component after mixing. A partition molded body that is slidably disposed in the through hole, the partition gasket is moved from the closed region to the discharge region, and the partition gasket is the partition molded body. The sequential discharge path is opened by relative movement with respect to.

  The invention according to claim 4 is the invention according to claim 2, wherein the sequential discharge means is formed in the partition gasket disposed between the sequential discharge component and the mixed component after mixing. A partition molded body slidably disposed in the through hole, the partition gasket is moved from the closed region to the discharge region, and the partition molded body is the partition gasket. The sequential discharge path is opened by relative movement with respect to.

  According to a fifth aspect of the present invention, in the invention according to any one of the first to fourth aspects, the partition gasket for partitioning the mixing storage chamber and the sequential discharge storage chamber is the communication region. , The sequential discharge accommodating chamber and the mixing accommodating chamber communicate with each other through the communication path, and the sequentially discharged components can be transferred to the mixing accommodating chamber side. .

  The invention according to claim 6 is the invention according to any one of claims 1 to 5, further comprising a closing means for closing the discharge portion, and the most discharge of the plurality of mixing chambers. A powder preparation or a freeze-dried preparation is stored in the storage chamber on the part side.

  A seventh aspect of the present invention is the invention according to any one of the first to sixth aspects, wherein the mixed component of the plurality of mixing chambers dissolves the component to be dissolved and the component to be dissolved. And the sequentially discharged component is an adjustment liquid that adjusts the mixed solution of the dissolved component and the dissolving solution, the dissolved component is hardly soluble in water, and the dissolving solution is the dissolved component. Is characterized by high solubility.

  The invention described in claim 8 is characterized in that, in the invention described in claim 7, the adjustment liquid is a liquid that adjusts the pH of a solution in which the component to be dissolved is dissolved in the solution for dissolution.

  The invention according to claim 9 is the invention according to any one of claims 1 to 6, wherein the sequentially discharged component is an extrusion medium for extruding the mixed component after mixing. To do.

  According to the first aspect of the present invention, the plurality of mixing components discharged after mixing in the outer cylinder are accommodated in the plurality of mixing chambers provided adjacent to each other from the discharge portion side. In the sequential discharge storage chamber provided on the plunger side from the plurality of mixing storage chambers, sequential discharge components discharged after the mixed component are stored, and by moving the plunger gasket to the discharge portion side, Mixing and discharging means that communicates between the mixing chambers and transfers the mixed components in the mixing chamber on the plunger gasket side to the mixing chamber on the discharge side, and the plunger gasket after discharging the mixed components on the discharge side The operation of mixing and discharging a plurality of mixed components stored in a prefilled syringe is provided with sequential discharge means that can sequentially discharge discharged components from the discharge section by moving to Provided is a prefilled syringe capable of performing an operation of sequentially discharging components other than the mixed components by pressing the plunger, and capable of setting a mixing order and a discharging order of a plurality of accommodated components. be able to.

  According to the second aspect of the present invention, the partitioning gasket for partitioning the mixing storage chambers includes the communication passage that communicates between the mixing storage chambers by reaching the communication region, and is sequentially mixed with the discharged components. Since the partition gasket arranged between the mixed components has a sequential discharge path that opens when reaching the discharge area closer to the discharge section than the communication area, the discharge path is sequentially opened in the discharge area. A plurality of mixed components can be more reliably mixed before the discharged components are discharged, and the mixed components after mixing can be more reliably discharged from the discharge portion.

  According to the third aspect of the present invention, the sequential discharge means is arranged to be slidable in the through hole formed in the partitioning gasket disposed between the sequential discharge component and the mixed component after mixing. The partitioning gasket is moved from the closed region to the discharge region, and the partitioning gasket is moved relative to the partitioning molding, whereby the discharge path is opened. Therefore, it is easy to provide the discharge area near the position where the discharge of the mixed components after mixing is completed, and the discharged components can be discharged sequentially after the discharge of the mixed components is substantially completed.

  According to the fourth aspect of the present invention, the sequential discharge means is arranged to be slidable in the through hole formed in the partitioning gasket disposed between the sequential discharge component and the mixed component after mixing. The partition gasket is moved from the closed region to the discharge region, and the partition molding is moved relative to the partition gasket, whereby the discharge path is opened. Therefore, it is easy to provide the discharge area near the position where the discharge of the mixed components after mixing is completed, and the discharged components can be discharged sequentially after the discharge of the mixed components is substantially completed.

  According to the fifth aspect of the present invention, when the partitioning gasket for partitioning between the mixing storage chamber and the sequential discharge storage chamber reaches the communication area, the discharge storage chamber and the mixing storage chamber are sequentially formed. Since the gaps are communicated by the communication path and the discharged components can be sequentially transferred to the mixing storage chamber side, the sequential discharge means for sequentially discharging the discharged components from the discharge portion can be made simpler.

  According to the sixth aspect of the present invention, the powder preparation or the freeze-dried preparation is accommodated in the mixing storage chamber on the most discharge portion side among the plurality of mixing storage chambers. Therefore, even when the discharge part is closed by the closing means, when the plunger is pressed, the gas in the mixing storage chamber is compressed. It can be moved to the discharge part side, and mixing operation of the mixing components can be performed without opening the discharge part if the mixing storage chambers communicate with each other by the mixing discharge means at the moved position. . In addition, when pressing the plunger, the blocking means for closing the discharge part is removed in advance, and even if the injection needle or liquid feeding tube is connected to the discharge part or directly connected to the connector of the medical container as necessary, the mixed component The mixing operation can be performed.

  According to the seventh and eighth aspects of the present invention, the mixed components in the plurality of mixing chambers are composed of the dissolved components and the dissolving liquid, and the discharge components are sequentially mixed with the dissolved components and the dissolving liquid. Even if a component that is hardly soluble in water is used as a component to be dissolved, it can be dissolved in a dissolving solution that is easier to dissolve, and the dissolving operation is easy. That is, even when a hardly soluble component to be dissolved is dissolved in an acidic or alkaline solution, the adjustment of the pH is facilitated by the adjustment solution.

  According to the ninth aspect of the present invention, since the sequentially discharged component is an extrusion medium for extruding the mixed component after mixing, a plurality of mixed components can be sequentially discharged by the discharged component and discharged. The amount of the medicinal component remaining in the inside can be suppressed as much as possible, and therefore, it is possible to reliably discharge substantially the entire amount of the mixed component.

Embodiments of the present invention will be described below.
1 to 4 show this embodiment.

In the figure, reference numeral 10 denotes a three-chamber prefilled syringe. The prefilled syringe 10 is connected to the outer cylinder 12 having the discharge portion 11 on the front end side, the plunger 14 disposed on the rear end side of the outer cylinder 12, and the front end side of the plunger 14, and is liquid-tight in the outer cylinder 12. The plunger gasket 15 slidably disposed, and the front partition disposed in a liquid-tight and slidable manner on the discharge portion 11 side between the plunger gasket 15 and the discharge portion 11 in the outer cylinder 12. Gasket 16X, and an intermediate partition gasket 16Y disposed between the plunger gasket 15 and the front partition gasket 16X in a liquid-tight and slidable manner.
A discharge port 11c and a luer lock structure 11b are provided on the end surface 11a of the discharge unit 11, and the tip of the discharge port 11c is sealed with a tip cap 11d as a closing means.

  Here, a front mixing storage chamber 18a is defined between the front partition gasket 16X and the discharge portion 11, and an internal mixing storage chamber 18b is provided between the front partition gasket 16X and the intermediate partition gasket 16Y. A discharge storage chamber 19 is sequentially partitioned between the intermediate partition gasket 16Y and the plunger gasket 15, and the front mixing storage chamber 18a and the internal mixing storage chamber 18b are divided into the front partition gasket 16X. The internal mixing storage chamber 18b and the sequential discharge storage chamber 19 are disposed adjacent to each other via the intermediate partition gasket 16Y.

  Each of the storage chambers 18a, 18b, and 19 stores various gases, liquids, powders, and other substances that are isolated from each other at the time of manufacture and storage and are used at the same time as different components. Examples of these substances include a chemical solution that is dissolved or mixed in the prefilled syringe 10 and then mixed into an infusion solution, or a chemical solution that is directly administered to the human body.

  In the present invention, the front mixing storage chamber 18a and the internal mixing storage chamber 18b store mixed components that are preferably discharged after mixing in the outer cylinder. A sequential discharge component that is used together with the mixed components stored in the front mixing storage chamber 18a and the internal mixing storage chamber 18b and preferably discharged after the mixed components is stored.

  As this mixed component, the dissolved component of the powder formulation or lyophilized formulation having a volume equal to or less than the volume of the front mixing chamber 18a is stored in the front mixing chamber 18a, and the dissolved component is stored in the inner mixing chamber 18b. It is preferred that a dissolving solution for dissolution is accommodated. Here, the powder preparation or lyophilized preparation accommodated in the front mixing storage chamber 18a has a volume equal to or less than the volume of the front mixing storage chamber 18a. By storing a compressible fluid such as a gas together with the preparation, even if pressing of the plunger 14 is started in a state where the discharge portion 11 is closed by the tip cap 11d, the compressibility in the front mixing storage chamber 18a is increased. This is because when the fluid is compressed, the movement of the front partition gasket 16X is allowed and a communication path described later is opened.

  Here, it is preferable that the component to be dissolved is a hardly soluble component, in particular, a hardly soluble component with respect to a liquid having a pH of around 7 used for a normal chemical solution.

  At the same time, the liquid for dissolution is a liquid that can obtain higher solubility with respect to a hardly soluble component, particularly an acidic or alkaline liquid in the case of a component that is hardly soluble with respect to a liquid near pH 7. Is preferred.

  Further, as the sequentially discharged components, the adjustment liquid for adjusting the components to be dissolved and the components of the dissolution liquid, particularly the pH, is adjusted so that the proportion of the components contained in the prefilled syringe 10 as a whole is appropriate. It is preferable to use a liquid. The solubility of the dissolving solution in such a hardly soluble component to be dissolved should be higher than the solubility of the sequentially discharged component to the hardly soluble component to be dissolved or the mixture of the sequentially discharged component and the dissolving solution. preferable.

  Further, as this sequentially discharged component, the mixed component accommodated in the front mixing accommodating chamber 18a and the internal mixing accommodating chamber 18b can be used as an extruding liquid for extruding from the prefilled syringe 10. In that case, if it is not necessary to adjust the components of the mixture stored in the front mixing storage chamber 18a and the internal mixing storage chamber 18b, it is preferable to use physiological saline as the discharge component in sequence.

  In such a prefilled syringe 10, the front partition gasket 16 </ b> X is moved by a predetermined amount toward the discharge portion 11, thereby mixing the front mixing storage chamber 18 a and the internal mixing storage chamber 18 b. The discharge means 30 is provided, and the front partition gasket 16X is provided with opening / closing means 20 as sequential discharge means capable of communicating between both sides of the front partition gasket 16X.

The mixing and discharging means 30 has a communication passage 31 provided in the outer cylinder 12 and is formed in a groove shape extending in the longitudinal direction on the inner surface of the outer cylinder 12 by expanding a part of the outer cylinder 12 outward. Yes.
In this mixing and discharging means 30, the position in the outer cylinder 12 where the communication passage 31 is formed is the communication region L1, and when the front partition gasket 16X moves and reaches the communication region L1, the front mixing When the storage chamber 18a and the internal mixing storage chamber 18b communicate with each other through the communication path 31, and the intermediate partition gasket 16Y moves to reach the communication region L1, the internal mixing storage chamber 18b and the internal mixing storage chamber 18b are sequentially discharged. It is comprised so that between the storage chambers 19 may be connected.

  Here, the communication passage 31 can communicate between both sides of the front partition gasket 16X, and can communicate between both sides of the intermediate partition gasket 16Y, and the front partition gasket 16X and the intermediate partition gasket 16Y communicate with each other. When the region L1 is reached, the length is such that the front mixing storage chambers 18a and the discharge storage chambers 19 on both sides are not in communication with each other. In addition, the communication path 31 is provided so that when the intermediate partition gasket 16Y reaches the communication region L1, an outer space can be secured so that the front partition gasket 16X can move to the discharge portion 11 side from the communication region L1. The cylinder 12 is provided at an intermediate position in the longitudinal direction.

  As shown in FIGS. 1 and 2, the front partition gasket 16 </ b> X has an outer peripheral shape corresponding to the inner wall surface of the outer cylinder 12, and a plurality of rib-shaped outer peripheral seal portions 16 a formed in an annular shape around it. The opening / closing means 20 is provided inside. As the material of the front partition gasket 16X, the same material as the plunger gasket 15 can be exemplified.

  The opening / closing means 20 provided inside the front partition gasket 16X includes a through hole 21 formed in the front partition gasket 16X so as to be in the longitudinal direction of the outer cylinder 12, and a through hole as shown in FIG. And a partition molding 22 that is slidably disposed in the hole 21.

The through-hole 21 of the front partition gasket 16X has an inner peripheral shape corresponding to the shape of the partition molded body 22, and an inner peripheral seal portion 21a is formed on the inner periphery thereof. The inner peripheral seal portion 21a is formed at a position corresponding to the outer peripheral seal portion 16a.
Further, four convex portions 16b, 16b,... Are integrally formed on the end surface of the front partition gasket 16X on the plunger 14 side at substantially equal intervals in the circumferential direction.
When the front partition gasket 16X and the intermediate partition gasket 16Y come into contact with each other, the convex portion 16b has a predetermined gap between the end surface of the front partition gasket 16X and the end surface of the intermediate partition gasket 16Y. This is for securing the flow path.

  The partition molding 22 is formed using a material that can be used for the outer cylinder 12, and has a constant cross-sectional shape in the longitudinal direction as shown in FIGS. 1 and 3. It has a columnar sealing portion 23 that is in liquid-tight and slidable contact with the portion 21a over the entire circumference. Here, the sealing portion 23 is disposed in a state of penetrating the inner peripheral seal portion 21 a of the through hole 21, and a flange portion 26 larger than the through hole 21 is formed on the inner mixing accommodating chamber 18 b side of the sealing portion 23. Yes.

  Projecting from the sealing portion 23 to the discharge portion 11 side so as to protrude from the end portion on the discharge portion 11 side of the front partition gasket 16X to the discharge portion 11 side in a state where the sealing portion 23 is disposed in the through hole 21. A portion 24 is provided. In this embodiment, the projecting portion 24 is formed continuously from the sealing portion 23, and includes a plurality of rib pieces 24 a formed to have an outer periphery smaller than the outer peripheral shape of the sealing portion 23.

  A groove-shaped communication path 25 formed between the rib pieces 24a and 24a is formed on the surface of the molded body 22 for partitioning on the discharge unit 11 side from the sealing portion 23, here, the surface of the protruding portion 24. It is formed so as to be distributed substantially evenly around the body 22. The communication path 25 is closed between the internal mixing chamber 18b by the inner peripheral sealing portion 21a on the one end 25a side in a state where the sealing portion 23 is disposed on the inner peripheral sealing portion 21a of the through hole 21. The partition molding 22 is opened by moving relative to the front partition gasket 16X, and communicates between both end faces of the front partition gasket 16X. Further, a notch-like recess 24b is formed at the end of the rib piece 24a on the discharge portion 11 side at a position facing the discharge port 11c, and the protruding portion 24 contacts the end surface 11a of the discharge portion 11. In this state, a flow path between the communication passage 25 and the discharge port 11c can be secured.

  In such an opening / closing means 20, in a state where the sealing portion 23 is disposed on the inner peripheral seal portion 21a of the through hole 21, the communication path 25 is closed by the inner peripheral seal portion 21a on the inner mixing chamber 18b side. . When the partition molding 22 moves relative to the plunger 14 side relative to the front partition gasket 16X, and the sealing portion 23 moves from the inner peripheral seal portion 21a of the through hole 21 toward the plunger 14, the communication passage 25 The interior mixing chamber 18b is opened, and both sides of the front partitioning gasket 16X are communicated with each other by a communication passage 25.

In such a prefilled syringe 10, the outer cylinder 12 and the partition molding 22 are rigid and stable with respect to the contents of the front mixing storage chamber 18 a, the internal mixing storage chamber 18 b, and the sequential discharge storage chamber 19. It is made of a material such as various types of glass or synthetic resin.
Synthetic resins that can be used as the material of the outer cylinder 12 and the partition molding 22 include polyolefins such as low-density or high-density polyethylene, polypropylene, and polybutadiene-1, polyvinyl chloride, polyvinylidene chloride, and vinylidene chloride copolymers. , Polymethyl methacrylate, ethylene-vinyl alcohol copolymer, acrylonitrile copolymer, polyethylene terephthalate, polyethylene naphthalate, and the like.

  Polyolefins are preferred to prevent adverse effects such as eluate when accommodating a medicine or the like to be administered to the human body in the front mixing storage chamber 18a, the internal mixing storage chamber 18b, and the sequential discharge storage chamber 19. In particular, since a powder formulation and a lyophilized formulation are accommodated, it is preferable to use a cyclic polyolefin that has good water vapor barrier properties and is difficult to adsorb components.

  Each of the plunger gasket 15 and the intermediate partition gasket 16Y has an outer peripheral shape corresponding to the inner wall surface of the outer cylinder 12, and has a plurality of rib-shaped outer peripheral seal portions 15s and 16s formed in an annular shape around the periphery. Is formed. These are made of an elastically deformable material, and the outer peripheral seal portions 15s and 16s are in fluid-tight and slidable contact with the inner wall surface of the outer cylinder 12 due to their elasticity.

  Examples of materials for the plunger gasket 15, front partition gasket 16X, and intermediate partition gasket 16Y include halogenated butyl rubbers such as chlorine and bromine, butyl rubbers such as divinylbenzene copolymer partially crosslinked butyl rubber, and butyl rubber. Non-conjugated diene rubbers such as rubber, ethylene-propylene copolymer rubber (EPR), ethylene-propylene-diene monomer terpolymer rubber (EPDM), polyisoprene rubber, polybutadiene rubber, styrene butadiene copolymer rubber (SBR), Various rubber materials such as acrylonitrile-butadiene copolymer rubber (NBR), natural rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, and silicone rubber, various elastomers such as polyurethane, polyester, polyamide, olefin, and styrene Mer, or can be a material having a sealable resilient liquid-tight between these mixtures, the cylinder wall or the molded body.

The materials of the plunger gasket 15, the front partition gasket 16X, and the intermediate partition gasket 16Y may all be the same, or may be different from each other depending on the contents. At that time, in particular, the front partition gasket 16X constituting the front mixing storage chamber 18a in which the powder preparation and the freeze-dried preparation are stored is preferably a butyl rubber having a good water vapor barrier property. In the case of storing an easily-contained object, it is preferable to perform lamination or surface treatment on the surface in contact with the object to reduce the adsorptivity of the object.
For the same reason, a butyl rubber having a high water vapor barrier property is also suitable for the chip cap 11d.

The prefilled syringe 10 having the above configuration is used as follows.
First, in the storage state, as shown in FIG. 4A, the plunger 14 is disposed on the rear end side of the outer cylinder 12, and the front mixing storage chamber 18a, the internal mixing storage chamber 18b, and the sequential discharge chamber are disposed. A predetermined amount of mixed components or sequentially discharged components are separately stored in the storage chamber 19.

  In this state, the front partition gasket 16X and the intermediate partition gasket 16Y are disposed closer to the plunger 14 than the communication path 31, and the front partition gasket 16X is disposed in the closed region. Moreover, the discharge part 11 is also obstruct | occluded. Therefore, the front mixing storage chamber 18a, the internal mixing storage chamber 18b, and the sequential discharge storage chamber 19 are all maintained in a sealed state.

  Here, the closed region of the front partition gasket 16X is a moving range in which the communication path 25 from the position where the front partition gasket 16X is initially arranged to the vicinity of the discharge unit 11 can be maintained in a closed state. This is the section where components are discharged. Specifically, the movement range of the front partition gasket 16 </ b> X until the projecting portion 24 protruding from the end portion on the discharge portion 11 side of the front partition gasket 16 </ b> X to the discharge portion 11 side contacts the end surface 11 a of the discharge portion 11. Thus, it is determined by the protruding amount of the protruding portion 24.

  In this closed region, the sealing portion 23 is disposed in contact with the inner peripheral seal portion 21a of the through hole 21 in a state of penetrating the inner peripheral seal portion 21a. Further, the protruding portion 24 protrudes toward the discharge portion 11 side from the end portion on the discharge portion 11 side of the front partition gasket 16X, and the end portion on the internal mixing chamber 18b side of the communication passage 25 is closed by the inner peripheral seal portion 21a. Has been. Therefore, the space between the front mixing storage chamber 18a and the internal mixing storage chamber 18b is reliably maintained in a sealed state.

  In order to discharge the storage liquid stored in the front mixing storage chamber 18a and the storage liquid stored in the internal mixing storage chamber 18b and the sequential discharge storage chamber 19 from the discharge port 11c, first, the plunger 14 When starting pressing, the tip cap 11d is removed, and if necessary, a luer lock structure 11b is connected to an injection needle or a liquid feeding tube (not shown) or directly connected to a connector of a medical container, and then the plunger 14 is discharged. By pressing toward the portion 11 side, the front partition gasket 16X is closed along with the sequential discharge components of the discharge storage chamber 19, the intermediate partition gasket 16Y, and the mixed components of the internal mixing storage chamber 18b. To reach the communication region L1 as shown in FIG. 4 (b). Then, the front mixing storage chamber 18a and the internal mixing storage chamber 18b communicate with each other through the communication passage 31.

  In addition, you may make it start pressing of the plunger 14 in the state which obstruct | occluded the discharge part 11 with the chip | tip cap 11d. In this case, the compressive fluid in the front mixing storage chamber 18a is compressed, so that the front partition gasket 16X moves and the communication passage 31 is opened.

  In this state, when the plunger 14 is further pressed toward the discharge portion 11, the intermediate partition gasket 16 </ b> Y is pressed and moved sequentially through the discharge components in the discharge storage chamber 19, and the mixing in the internal mixing storage chamber 18 b is performed. The components are transferred to the front mixing storage chamber 18 a via the communication path 31. Then, in the front mixing storage chamber 18a, the mixed components in the internal mixing storage chamber 18b and the mixed components in the front mixing storage chamber 18a are mixed to form a solution or dispersion.

  After the mixed components in the internal mixing chamber 18b are transferred to the front mixing chamber 18a, as shown in FIG. 4 (c), the front partition gasket 16X that has remained in the communication region L1 is used as an intermediate partition. The gasket 16Y comes into contact.

  Next, the plunger 14 is further pressed to the discharge part 11 side. Then, the front partition gasket 16X is pressed through the sequential discharge components of the discharge chamber 19 and the intermediate partition gasket 16Y, and the front partition gasket 16X moves toward the discharge portion 11 to move the front partition gasket 16X. The solution or dispersion liquid composed of the mixed components after mixing in the partial mixing chamber 18 a is discharged from the discharge portion 11.

  Then, by continuing to discharge the mixed components after mixing, when the intermediate partition gasket 16Y reaches the communication region L1, as shown in FIG. The storage chamber 18b is in communication.

  Here, the front partition gasket 16X and the intermediate partition gasket 16Y are in contact with each other, but the internal mixing chamber 18b has a gap between the front partition gasket 16X and the intermediate partition gasket 16Y and the front. It consists of a concave portion 16c at the end of the through hole 21 of the partitioning gasket 16X on the plunger side, and has a sufficiently small volume.

Further, since convex portions 16b, 16b,... Are formed on the end face on the plunger 14 side of the front partition gasket 16X, a gap between the end face of the front partition gasket 16X and the end face of the intermediate partition gasket 16Y. A flow path for communicating from the communication path 31 to the recess 16c is formed.
When the plunger 14 is further pressed from this state, the sequentially discharged components in the discharge accommodating chamber 19 are sequentially pressurized by the plunger gasket 15 and transferred to the internal mixing accommodating chamber 18 b via the communication path 31.

  At this time, since the front partition gasket 16X is disposed on the discharge side from the communication region L1, the front mixing storage chamber 18a and the internal mixing storage chamber 18b are not communicated with each other through the communication path 31. Moreover, the flange portion 26 is in contact with the end portions on the side of the plunger 14 of the front partition gasket 16X and the intermediate partition gasket 16Y in a state in which the internal pressure in the internal mixing chamber 18b is loaded. The molded body 22 is maintained at the initial relative position in the through-hole 21, and the internal mixing storage chamber 18b and the sequential discharge storage chamber 19 are maintained in a liquid-tightly closed state. Therefore, the sequentially discharged components that have been transferred are stored in the internal mixing chamber 18b.

When the plunger 14 is continuously pressed, the front partition gasket 16X moves toward the discharge portion 11 due to the internal pressure as the volume of the discharge component in the internal mixing chamber 18b increases sequentially. The solution or dispersion liquid composed of the mixed components after mixing in the front mixing storage chamber 18 a is further discharged from the discharge portion 11.
When the discharge of the mixed components proceeds in this state, as shown in FIG. 4E, the front partition gasket 16X reaches the discharge region.

  Here, the discharge area of the front partition gasket 16X is a movement range in the vicinity of the discharge section 11 of the front partition gasket 16X, and is a section in which discharged components in the internal mixing chamber 18b are discharged sequentially. . Specifically, this is the range of movement of the front partition gasket 16X after the partition molding 22 abuts against the end surface 11a of the discharge portion 11.

  Then, the protruding portion 24 of the partition molding 22 abuts against the end surface 11a of the discharge portion 11 to restrict the movement, and the front partition gasket 16X moves relative to the partition molding 22 toward the discharge portion 11 side. . As a result, the mixed components after mixing in the front mixing storage chamber 18a are sufficiently discharged from the discharge portion 11, and at the same time, as shown in FIG. By relative movement, the sealing portion 23 moves to the internal mixing storage chamber 18b side, the end of the communication path 25 on the internal mixing storage chamber 18b side opens to the internal mixing storage chamber 18b side, and the internal mixing storage chamber 18b communicates with the discharge port 11c.

  Thereafter, when the plunger 14 is further pressed, the sequentially discharged components stored in the internal mixing chamber 18 b are pressurized from the communication path 25 and discharged from the discharge unit 11 via the communication path 25. Then, as shown in FIG. 4 (g), when the intermediate partition gasket 16Y is completely moved to the discharge portion 11, the discharge components are sequentially discharged, and the mixed components and the sequential discharge from the prefilled syringe 10 are completed. The discharge of ingredients is complete.

  According to the prefilled syringe 10 as described above, it is discharged after being mixed in the front mixing storage chamber 18a and the internal mixing storage chamber 18b provided adjacent to each other on the discharge section 11 side in the outer cylinder 12. A plurality of mixed components are accommodated, and sequentially discharged components discharged after the mixed components are accommodated in a sequential discharge accommodating chamber 19 provided on the plunger 14 side from the mixing accommodating chambers 18a and 18b. By moving the plunger gasket 15 to the discharge portion side, the mixing and discharging means capable of communicating between the front mixing storage chamber 18a and the internal mixing storage chamber 18b to mix and discharge the mixed components. 30 and the opening / closing means 20 capable of sequentially discharging the discharged components after discharging the mixed components, so that a plurality of components contained in the prefilled syringe 10 are mixed. An operation for discharging, the operation and for sequentially discharging the separate components, can be performed by pressing operation of the plunger 14. Therefore, it is possible to set the mixing order and the discharging order of the contained components.

  Further, the front partition gasket 16X that partitions between the front mixing storage chamber 18a and the internal mixing storage chamber 18b reaches the communication region L1, so that the mixing storage chambers 18a and 18b communicate with each other. 31 and a front mixing storage chamber 18a in which mixed components after mixing are stored, an internal mixing storage chamber 18b in which discharge components are sequentially stored, and a sequential discharge storage chamber 19 before being disposed. Since the partitioning gasket 16X reaches the discharge area closer to the discharge section 11 than the communication area L1, the communication path 25 is opened. Therefore, the communication path 25 is opened in the discharge area and the exhaust components are sequentially discharged. Can be surely mixed with a plurality of mixed components before being discharged from the discharge portion 11 and easily discharged from the discharge portion 11.

  Further, the front partition gasket 16X includes a through hole 21 and a partition molding 22 that is slidably disposed in the through hole 21. Since the partition molding 22 is moved relative to the front partition gasket 16X by moving to the discharge region, the open / close means 20 is provided to open the communication passage 25. It is easy to provide in the vicinity of the position where the discharge of the mixed components is completed, and the discharged components are easily discharged sequentially after the discharge of the mixed components is substantially completed.

  Further, when the internal partitioning gasket 16Y that partitions between the internal mixing storage chamber 18b and the sequential discharge storage chamber 19 reaches the communication region L1, the internal mixing storage chamber 18b and the sequential discharge storage chamber 19 are sequentially separated. Since the communication path 31 communicates with each other, no special means for sequentially transferring the discharged components from the discharge storage chamber 19 to the internal mixing storage chamber 18b is necessary, and the discharge components are sequentially discharged from the discharge section 11. It is possible to more easily configure the means for sequential discharge for the purpose.

  Further, the chip cap 11d that closes the discharge portion 11 is provided, and the discharge portion 11 is closed by the tip cap 11d if a compressible fluid such as gas is mixed together with the mixed component in the front mixing storage chamber 18a. Even if the plunger 14 is pressed by the compression gasket, the compressive fluid in the front mixing storage chamber 18a is compressed, thereby separating the front mixing storage chamber 18a and the internal mixing storage chamber 18b. 16X can be moved to the discharge unit 11 side. Therefore, if the mixing chambers 18 a and 18 b are communicated with each other by this movement by the mixing and discharging means 30, it is possible to perform the mixing operation of the mixed components without opening the discharging unit 11.

  Moreover, in this prefilled syringe 10, a component to be dissolved is stored as a mixed component of the front mixing storage chamber 18a, a dissolved component is stored as a mixed component of the internal mixing storage chamber 18b, and the discharge storage chamber 19 is sequentially arranged. Accommodates adjustment liquid for adjusting the components to be dissolved and dissolution liquid as discharge components, and the solubility of the dissolution liquid with respect to the dissolution target component is adjusted with respect to the dissolution target component of the adjustment liquid and the mixture of adjustment liquid and dissolution liquid If the solubility is higher, even if a hardly soluble component is used as the component to be dissolved, it can be dissolved by a dissolving solution that is easier to dissolve, so that the dissolving operation is easy. Moreover, in order to use such a solution for dissolution, even if the mixed components after mixing are administered to a patient or mixedly injected, even if they have physical properties and compositions that are inappropriate as chemical solutions, they should be adjusted with the adjustment solution. Therefore, it is possible to make the physical properties and composition of the chemical solution appropriate for the prefilled syringe as a whole.

  In particular, there are drugs that have a large influence on pH in solubility when dissolving the components to be dissolved in the solution for dissolution. However, when such a drug is used as the component to be dissolved, a liquid with a pH that is easy to dissolve is used. If the liquid which adjusts pH of a solution is used as an adjustment liquid, the outstanding effect will be acquired.

  Furthermore, if an extrusion liquid for extruding the mixed component after mixing is used as the sequential discharge component of the sequential discharge storage chamber 19, a plurality of mixed components can be sequentially pushed out by the discharge component and discharged from the discharge unit 11, The amount of each mixed component remaining in the prefilled syringe 10 can be suppressed as much as possible, and can be substantially eliminated. Therefore, substantially all of the mixed components can be reliably discharged.

  In the prefilled syringe 10, the opening / closing means 20 and the communication path 31 are combined. Therefore, when the front partition gasket 16 </ b> X is moved to the discharge portion 11 side in the outer cylinder 12, the opening / closing means 20 is in the closed region. When the position of the communication path 31 is reached in the closed state, the front mixing storage chamber 18a and the internal mixing storage chamber 18b on both sides can be communicated with each other. When the closed region is moved in a state where the chambers 18a and 18b are separated and reach the discharge region, the opening / closing means 20 is opened, and the mixing storage chambers 18a and 18b on both sides can be communicated again. Therefore, by simply moving the front partition gasket 16X to the discharge portion 11 side of the outer cylinder 12, the mixing storage chambers 18a and 18b on both sides can be communicated twice, and the mixing order and discharge of a plurality of components can be achieved. It can be particularly suitably used for adjusting the order and the like.

Further, as shown in FIGS. 5A and 5B, pressing of the plunger 14 may be started in a state where the discharge portion 11 is closed by the tip cap 11d. In this case, when the compressive fluid in the front mixing storage chamber 18a is compressed, the front partition gasket 16X moves and reaches the communication region L1, and the front mixing storage chamber 31 is reached by the communication passage 31. 18a communicates with the internal mixing chamber 18b.
Thereafter, the tip cap 11d may be removed, and if necessary, an injection needle or a liquid feeding tube (not shown) may be connected to the luer lock structure 11b or directly connected to the connector of the medical container. In FIG. 5, steps (c) to (g) are the same as steps (c) to (g) in FIG.

In addition, although the example which accommodated the medical chemical | medical solution was demonstrated in the said embodiment, even if it is a prefilled syringe used for uses other than medical use, it is possible to apply this invention.
In the above description, the outer cylinder 12 is bulged outwardly to form a groove shape as the communication path 31, but the communication path 31 is not particularly limited as long as it communicates between both sides of each partitioning gasket. . For example, as illustrated in FIG. 6, the communication path 31 a may be formed in a groove shape on the inner surface of the outer cylinder 12 without causing the outer cylinder 12 to bulge.

  Further, in the above description, as the opening / closing means 20, the partition molding 22 has the flange portion 26 on the plunger 14 side and the projection 24 projects on the discharge portion 11 side, and the partition molding 22 moves to the plunger 14 side. Although the thing in which the communicating path 25 is formed was demonstrated by this, it is not specifically limited.

  For example, as shown in FIG. 7A, as the opening / closing means 20, the partitioning molded body 32 has a flange portion 36 and a sealing portion 33 on the discharge portion 11 side, and has a communication passage 35 inside. As shown in (b), the partition molding 32 moves relative to the front partition gasket 16X toward the discharge section 11, whereby the communication path 35 communicates between both sides of the front partition gasket 16X. It is also possible to configure as described above. In that case, after the front partition gasket 16X comes into contact with the discharge portion 11, the partition molding 32 may be relatively moved by the internal pressure of the mixed component in the internal mixing chamber 18b.

  It is sectional drawing which shows the prefilled syringe of embodiment of this invention.   The gasket for front part partition of the prefilled syringe of Drawing 1 is shown, (a) is a perspective view and (b) is a sectional view.   The molded object for partitioning of the prefilled syringe of FIG. 1 is shown, (a) is a perspective view, (b) is sectional drawing.   (A)-(g) is a figure explaining the discharge | emission state of each component accommodated in the prefilled syringe of FIG.   (A)-(g) is a figure explaining the other example of the discharge | emission state of each component accommodated in the prefilled syringe of FIG.   It is sectional drawing which shows the modification of the communicating path of the prefilled syringe of FIG.   It is a partial cross section figure which shows the modification of the opening / closing means of the prefilled syringe of FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 Prefilled syringe 11 Discharge part 12 Outer cylinder 14 Plunger 15 Plunger gasket 16X Front partition gasket 16Y Intermediate partition gasket 18a Front mixing storage chamber 18b Internal mixing storage chamber 19 Sequential discharge storage chamber 20 Opening / closing means 21 Through Hole 22 Partition molded body 24 Projection portion 25 Communication path 30 Mixing and discharging means 31 Communication path

Claims (9)

An outer cylinder having a discharge part, a plunger gasket arranged in a liquid-tight manner in the outer cylinder, and three or more chambers arranged in a liquid-tight manner between the discharge part and the plunger gasket in the outer cylinder A prefilled syringe comprising a plurality of partitioning gaskets for partitioning the storage chamber of
A plurality of mixing chambers in which the three or more storage chambers are provided adjacent to each other from the discharge portion side and separately store a plurality of mixed components that are mixed and discharged in the outer cylinder. And a sequential discharge storage chamber that is provided closer to the plunger than the plurality of mixing storage chambers and stores a sequential discharge component discharged after the mixing component,
By moving the plunger gasket toward the discharge portion, the mixing components in the mixing chamber on the plunger gasket side are communicated between the mixing chambers to the mixing chamber on the discharge portion side. Mixed discharge means to be transferred;
A prefilled syringe comprising: a sequential discharge means capable of discharging the sequential discharge components from the discharge section by moving the plunger gasket toward the discharge section after discharging the mixed components. The mixing and discharging means includes a communication passage that communicates between the mixing chambers when the partitioning gasket that partitions the mixing chambers reaches a communication region.
The sequential discharge means sequentially discharges when the partitioning gasket disposed between the sequential discharge component and the mixed component after mixing reaches the discharge region on the discharge portion side with respect to the communication region. The prefilled syringe according to claim 1, further comprising a passage.   The sequential discharge means includes a through hole formed in the partition gasket disposed between the sequential discharge component and the mixed component after mixing, and a partition molding disposed so as to be slidable in the through hole. The partition gasket moves from the closed region to the discharge region, and the partition gasket moves relative to the partition molded body, whereby the sequential discharge path is opened. The prefilled syringe according to claim 2, characterized in that   The sequential discharge means includes a through hole formed in the partition gasket disposed between the sequential discharge component and the mixed component after mixing, and a partition molding disposed so as to be slidable in the through hole. The partition gasket is moved from the closed region to the discharge region, and the partition molding is moved relative to the partition gasket, whereby the sequential discharge path is opened. The prefilled syringe according to claim 2, characterized in that   The partitioning gasket for partitioning between the mixing storage chamber and the sequential discharge storage chamber reaches the communication region, whereby the sequential discharge path and the mixing storage chamber are connected to the communication path. The prefilled syringe according to any one of claims 1 to 4, wherein the pre-filled syringe is communicated with each other so that the sequentially discharged components can be transferred to the mixing chamber.   The apparatus further comprises closing means for closing the discharge part, and a powder preparation or a freeze-dried preparation is stored in the storage chamber closest to the discharge part among the plurality of storage chambers. The prefilled syringe according to any one of 1 to 5.   Adjustment in which the mixed liquid in the plurality of mixing chambers is composed of a dissolved component and a dissolving liquid that dissolves the dissolved component, and the discharge component sequentially adjusts the mixed liquid of the dissolved component and the dissolving liquid The prefilled syringe according to any one of claims 1 to 6, wherein the prefilled syringe is made of a liquid, the dissolved component is sparingly soluble in water, and the dissolving liquid has a high solubility in the dissolved component. .   The prefilled syringe according to claim 7, wherein the adjustment liquid is a liquid for adjusting a pH of a solution obtained by dissolving the component to be dissolved in the solution for dissolution.   The prefilled syringe according to claim 1, wherein the sequentially discharged component is an extrusion medium for extruding the mixed component after mixing.

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