JP2013042826A - Syringe container, prefilled syringe and method for manufacturing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a syringe container capable of reducing the number of steps of introducing a dissolved solution, enabling a solvent vaporized by freeze-drying to be reused, and preventing impurities from entering the inside of a syringe.SOLUTION: This syringe container includes: an outer cylinder having a chemical solution exit on a tip; a chemical solution exit sealing section for sealing the chemical solution exit; a first chamber provided on the front end of the outer cylinder; a second chamber provided on the base end in the outer cylinder; a partition wall portion having an opening provided in the outer cylinder and partitioning the first and second chambers; an openable-closable valve provided on the opening; a plunger moving through the inside of the outer cylinder; and a valve opening closing member movable through the outer cylinder in an axial direction of the outer cylinder. In the container, the valve is opened and closed in accordance with the movement of the valve opening closing member.

Description

  The present invention relates to a syringe container, a prefilled syringe, and a method for producing the same. More specifically, the present invention relates to a syringe container, a prefilled syringe, and a method for producing the same, in which a freeze-dried drug and a solvent for dissolving the drug are separated and accommodated and can be administered after the drug is dissolved in the solvent at the time of use.

  The syringe containing the injection solution is divided into two chambers and stored in a state where the predetermined component and its solution or dispersion are separated, and the predetermined component is maintained in a dry state to ensure a shelf life, A two-chamber prefilled syringe that facilitates storage is known (for example, see Patent Document 1).

  In the syringe cylinder 1 of the two-chamber syringe described in Patent Document 1, the inside is divided into the front chamber and the rear chamber by a stopper, and the solvent and the stopper in the rear chamber are moved toward the front chamber by pressing the syringe piston, Mixing the solvent with the anterior chamber drug is described.

  In order to accommodate a drug substance as a drug with high stability and high reliability, freeze-drying, which is a process for removing volatile substances such as water from a chemical solution, is preferably used. It is known that if the syringe itself is used as a freeze-dried container, it is not necessary to transfer the freeze-dried drug (see, for example, Patent Documents 2 and 3).

  In the syringe system described in Patent Document 2, for the purpose of freeze-drying the contained drug solution, a discharge passage is provided for discharging the vapor of the drug solution from the drug chamber, and after the freeze-drying, the discharge passage is sealed with a closed tip. It is described.

  In the two-chamber container / syringe described in Patent Document 3, it is described that an intermediate stopper is inserted and fitted into the insertion hole for the purpose of maintaining the sealed state as the container.

JP-A-4-322626 Special table 2003-535624 gazette JP 2008-67982 A

  However, the two-chamber type prefilled syringe as described above requires a step of separately introducing a solution or the like into the other of the two chambers after the dry medicine is accommodated and sealed in one of the two chambers. The syringe or the like described in Patent Document 2 or 3 can freeze-dry the drug solution after containing the drug solution, but the solvent component (typically water) of the drug solution is sublimated during the freeze-drying process. In order to diffuse to the surrounding environment, a step of introducing a solution or the like from the outside of the syringe after lyophilization is required. That is, the two-chamber prefilled syringe of the prior art requires a step of introducing a dissolving solution by an external pipe or the like, and there is a possibility that impurities are brought into the syringe accompanying the introduction of the dissolving solution from the outside. It was.

  This invention is made | formed in view of the said problem, Comprising: It aims at reducing the process of solution introduction and reusing the solvent evaporated by freeze-drying. Furthermore, it aims at providing the container for syringes, the prefilled syringe, and its manufacturing method in which a foreign material does not enter into the inside of a syringe.

  Such an object is achieved by the present inventions (1) to (11) below.

(1) An outer cylinder having a chemical liquid outlet at the distal end, a chemical liquid outlet sealing portion for sealing the chemical liquid outlet, a first chamber provided at a distal end side in the outer cylinder, and a proximal end side in the outer cylinder A second chamber provided in the outer cylinder, a partition wall having an opening provided in the outer cylinder, and partitioning the first chamber and the second chamber; an openable / closable valve body provided in the opening; A plunger that moves in an outer cylinder; and a valve opening and closing member that is movable in the axial direction of the outer cylinder in the outer cylinder, and the valve body opens and closes as the valve opening and closing member moves. Syringe container.

(2) The syringe container according to (1), wherein the valve opening / closing member is integrally formed at a distal end of the plunger.
(3) The syringe container according to (1), wherein the plunger has a cylindrical shape, and the valve opening / closing member moves in the plunger lumen.
(4) The valve opening / closing member presses the valve body in accordance with the movement in the distal direction, and puts the valve body into a sealed state, according to any one of (1) to (3) Syringe container.
(5) The syringe according to any one of (1) to (3), wherein the valve opening member is inserted through the valve body in accordance with movement in a distal direction, thereby bringing the valve body into a released state. Container.
(6) The syringe container according to any one of (1) to (5), wherein the plunger has a cylindrical shape, and the second chamber is formed in a lumen of the plunger.
(7) The syringe container according to any one of (1) to (6), further including an inner cylinder having a distal end portion fixed to the partition wall between the outer cylinder and the plunger. .
(8) A pusher can be attached to the base end side of the plunger, and the plunger moves in the outer cylinder in accordance with the movement of the pusher. (1) to (7) A prefilled syringe according to any one of the above.

  (9) The valve opening and closing member causes the valve body to evaporate the chemical stored in the first chamber by freeze-drying, and cools and freezes the evaporated solvent in the second chamber by a predetermined cooling means. 1 release state, a sealed state in which the frozen solvent is melted in the second chamber, a solute contained in the first chamber, and a second release state in which the solvent contained in the second chamber is mixed. The prefilled syringe according to any one of (1) to (8), characterized by comprising:

(10) An outer cylinder, a first chamber provided on a distal end side in the outer cylinder, a second chamber provided on a proximal end side in the outer cylinder, and an opening provided in the outer cylinder. A partition that partitions the first chamber and the second chamber, an openable / closable valve body provided in the opening, a plunger that moves in the outer cylinder, and an axial direction of the outer cylinder in the outer cylinder A syringe having a valve opening and closing member that opens and closes the valve body as it moves to a position, and in the opened state of the valve body, freezing the chemical solution stored in the first chamber; and
In the open state of the valve body, evaporating the solvent of the chemical solution stored in the first chamber, cooling the evaporated solvent by the cooling means provided in the second chamber, and freezing the second chamber; And a step of melting the solvent frozen in the second chamber in the sealed state of the valve body.

  (11) An outer cylinder having a chemical liquid outlet at the tip, a chemical liquid outlet sealing member that seals the chemical liquid outlet, and a first chamber in which the lyophilized solute provided at the tip side in the outer cylinder is stored. A second chamber that is provided on the base end side in the outer cylinder and stores the solvent; a partition that has an opening provided in the outer cylinder and partitions the first chamber and the second chamber; A valve body that can be opened and closed provided in the opening, a plunger that moves in the outer cylinder, and a valve opening and closing member that opens and closes the valve body as the inside of the outer cylinder moves in the axial direction of the outer cylinder; In the syringe having the above-mentioned, the valve body is released by moving the valve opening and closing member, and the solute stored in the first chamber and the solvent stored in the second chamber are mixed. How to use the syringe.

  According to the present invention, there are provided a syringe container, a prefilled syringe, and a method for producing the same, which can reduce the step of introducing a solution, recycle the solvent evaporated by freeze-drying, and prevent impurities from entering the syringe. be able to.

It is sectional drawing which shows the 2 chamber type prefilled syringe which concerns on embodiment of this invention. It is a figure which shows the manufacture process of the two-chamber type prefilled syringe which concerns on embodiment of this invention. It is a figure which shows the use process of the 2 chamber type prefilled syringe which concerns on embodiment of this invention. It is a graph which shows the temperature control of the 1st chamber in the manufacture process of the 2 chamber type prefilled syringe which concerns on embodiment of this invention. It is a figure explaining the cooling means which concerns on embodiment of this invention. It is a figure which shows the manufacture process of the two-chamber type prefilled syringe which concerns on other embodiment of this invention. It is a figure which shows the use process of the two-chamber type prefilled syringe which concerns on other embodiment of this invention. It is a figure which shows the manufacture process of the two-chamber type prefilled syringe which concerns on other embodiment of this invention. It is a figure which shows the use process of the two-chamber type prefilled syringe which concerns on other embodiment of this invention. It is a figure which shows the manufacture process of the two-chamber type prefilled syringe which concerns on other embodiment of this invention. It is a figure which shows the use process of the two-chamber type prefilled syringe which concerns on other embodiment of this invention.

  Hereinafter, based on the form (henceforth an "embodiment") for carrying out the two-chamber prefilled syringe of the present invention, it explains in detail with reference to drawings. The embodiments described below exemplify objects and methods for embodying the technical idea of the present invention. The technical idea of the present invention includes the following types of constituent materials, constituent conditions, etc. It is not something specific. The technical idea of the present invention can be variously modified within the technical scope described in the claims.

  FIG. 1 is a cross-sectional view showing a two-chamber prefilled syringe 1 according to an embodiment of the present invention.

  The two-chamber prefilled syringe 1 includes an outer cylinder 2, a pusher 10, a plunger 13, a gasket 14 that is a partition wall, and an inner cylinder 15 as a whole. These components are made of materials well known in the art. For example, the outer cylinder 2, the pusher 10, and the plunger 13 are manufactured from a resin material that can be injection-molded, and the gasket 14 is manufactured from a chemical-resistant flexible material.

  The outer cylinder 2 includes a tapered portion 3 in which the inner diameter and the outer diameter of the outer cylinder 2 are gradually reduced on the distal end side, a distal end protruding portion 4 projecting outward through the tapered portion 3, and an opening on the proximal end side 5 An inner cylinder 15, a plunger 13, and a gasket 14 are inserted inside the outer cylinder 2. A cap or the like, which is a chemical solution outlet sealing member that seals the chemical solution outlet, is attached to the tip protruding portion 4. In use, a puncture needle, a liquid distribution tube, a sealing cap, or the like can be attached.

  The gasket 14 has an opening 8 a and partitions the drug chamber (first chamber) 6 on the distal end side and the solvent chamber (second chamber) 7 on the proximal end side inside the outer cylinder 2. A valve body 8 that can be opened and closed is provided in the central opening 8 a of the gasket 14.

  The valve body 8 can seal the opening 8a and opens toward the base end side when no external force is applied, and closes by the external force. For example, the valve body 8 is in a closed sealed state (closed state) when the end surface of the valve opening / closing member 13a on the distal end side of the plunger 13 abuts from above. When the valve opening / closing member 13a of the plunger 13 is separated, the open state is opened.

  In this embodiment, the inner cylinder 15 is fixedly disposed on the proximal end side of the outer cylinder 2 and can slide the inner plunger 13. The inner cylinder 15 has a gap with the outer wall of the plunger 13 on the proximal end side. The cooling means 20b (FIG. 2) can be inserted into this gap.

  The plunger 13 has a cylindrical shape with the proximal end side and the distal end side opened, and is configured to be movable in the inner cylinder or the outer cylinder. A valve opening / closing member 13 a is integrally formed at the tip of the plunger 13, and the opening 8 a is liquid-tightly sealed according to the contact state with the valve body 8 by the valve opening / closing member 13 a. As the valve opening / closing member 13a moves in the distal direction, the valve opening / closing member 13a comes into contact with the valve body 8 to seal the opening 8a in a liquid-tight manner. The plunger 13 has a concave portion that fits with the pusher 10 on the proximal end side, and the pusher 10 has a convex portion that fits into the concave portion on the distal end side. With such a structure, the plunger 13 and the pusher 10 can be integrated.

  FIG. 2 is a diagram showing a manufacturing process of the two-chamber prefilled syringe 1 according to the embodiment of the present invention. A description of components common to those in FIG. 1 is omitted.

  FIG. 2A is a diagram illustrating a process of storing the drug solution 25 in the drug chamber 6 on the distal end side of the outer cylinder 2. The proximal end side of the plunger 13 is open. The plunger 13 is separated from the gasket 14, and the valve body 8 of the gasket 14 is in an open state. Therefore, the medicine chamber 6 and the solvent chamber 7 are in communication. For example, the chemical liquid 25 is injected from the proximal end side of the plunger and is stored in the drug chamber 6. Or you may accommodate in a chemical | medical agent chamber from a plunger tip in the sealed state.

  A heater 21 is disposed outside the medicine chamber 6. Cooling means 20 a is disposed outside the solvent chamber 7, and cooling means 20 b is disposed outside the plunger 13. These heaters 21 and cooling means 20a, b control the evaporation of the solvent from the drug chamber 6 in the subsequent freeze-drying process, and at least a part of the surface of the plunger 13 exposed to the inside of the solvent chamber 7. Is cooled to a temperature below the freezing point of the solvent of the chemical solution 25. The cooling means 20a, b can be a metal plate or a metal rod that is cooled by contacting with a predetermined coolant such as chiller water when necessary, but is not limited thereto.

  After the chemical solution 25 is accommodated in the drug chamber 6, a preliminary freezing step in lyophilization is performed. That is, the entire outer cylinder 2 is frozen at a temperature at which the drug solution 25 can be frozen (below the eutectic point), and the drug solution 25 contained in the drug chamber 6 is frozen at a temperature below the freezing point.

  FIG. 2B is a diagram illustrating a process of freeze-drying the chemical solution 25. After the chemical solution 25 is frozen, the cooling means 20a, 20b continues to cool at least a part of the surface of the plunger 13 exposed inside the solvent chamber 7 to a temperature at which the solvent of the chemical solution 25 can be frozen, and the plunger. 13 is vacuumed and a solvent such as water is sublimated from the chemical solution 25. The sublimated solvent freezes on the surface of the inner wall of the plunger 13 and is held as a solid state solvent 22.

  During lyophilization, the drug chamber 6 can be heated by the heater 21 in order to promote evaporation of solvent sublimation from the chemical solution 25. Also during these periods, the inner walls of the solvent chamber 7 and the surface of the plunger 13 are cooled by the cooling means 20a, 20b, so that the frozen solvent is held in the solvent chamber 7.

  Although not shown, the surface of the inner wall of the plunger 13 may be provided with a plurality of protrusions capable of holding a frozen solvent or a structure for increasing the surface area inside the solvent chamber 7 like the protrusions. . As a result, the solvent evaporated from the medicine chamber 6 can easily exchange heat with the inner wall of the cooled plunger 13, and the frozen solvent can be held by the protrusions and can be easily accumulated.

  FIG. 2C is a diagram showing a process of putting the valve body 8 in a sealed state and a process of mounting the pusher 10.

  The valve body 8 is in a sealed state when the plunger 13 slides toward the distal end and the end surface on the distal end side of the plunger 13 presses the valve body 8. The drug chamber 6 and the solvent chamber 7 are isolated from each other. By sealing in this way, the medicine chamber 6 can accommodate the freeze-dried medicine 11 in a state where the medicine chamber 6 is sealed at a pressure lower than the atmospheric pressure.

  Next, in the mounting step, the pusher 10 is fitted into the concave portion of the plunger 13 to seal the solvent chamber 7. The pusher 10 is also used for sliding the plunger 13 and the gasket 14. In the present embodiment, the pusher 10 is used to allow the medicine chamber 6 and the solvent chamber 7 to communicate with each other by sliding the plunger 13 to the base end side by sliding to the base end side to open the valve body 8. be able to.

  As described above, the two-chambered prefilled syringe 1 in which the drug 11 lyophilized from the drug solution is stored in the drug chamber 6 and the solvent evaporated by freeze-drying of the drug solution is stored in the solvent chamber 7 can be manufactured. .

  FIG. 3 is a diagram illustrating a process of using the two-chamber prefilled syringe 1 according to the embodiment of the present invention.

  FIG. 3A is a diagram illustrating a process of opening the valve body 8. By sliding the pusher 10 from the distal end side to the proximal end side, the valve opening / closing member 13a on the distal end side of the plunger 13 is separated from the valve body 8, and the valve body 8 is opened.

  The pusher 10 and the plunger 13 may be integrally rotatable around the axis, and the valve body 8 may be opened and closed by the rotation of the pusher 10.

  When the drug chamber 6 and the solvent chamber 7 communicate with each other, the solvent 12 accommodated in the solvent chamber 7 can reach the drug 11 accommodated in the drug chamber 6 and dissolve it. Therefore, when the valve body 8 is changed from the sealed state to the opened state, the drug solution 25 in which the drug 11 is dissolved by the solvent 12 can be generated in the drug chamber 6.

  In the sealing process in the manufacturing process described above, the drug chamber 6 containing the freeze-dried drug 11 can be sealed at a pressure lower than the atmospheric pressure. For this reason, when the gasket 14 is opened, at least a part of the solvent accommodated in the solvent chamber 7 can be sucked into the drug chamber 6. Therefore, in the two-chamber prefilled syringe 1 of the present embodiment, the solvent accommodated in the solvent chamber 7 not only simply falls into the drug chamber 6 according to gravity, but can be sucked toward the drug chamber 6. It can be quickly contacted with the freeze-dried drug 11 to dissolve it.

  FIGS. 3B and 3C are views showing that the chemical liquid 25 is pushed out by the gasket 14. As shown in FIG. 3B, when the pusher 10 is slid to the distal end side, the valve opening / closing member 13a on the distal end side of the plunger 13 contacts the gasket 14 with the valve body 8 sealed. Further, as shown in FIG. 3C, when the pusher 10 is slid to the distal end side, the gasket 14 is pressed by the plunger 13 and moves to the distal end side of the drug chamber 6. Thereby, the chemical | medical solution 25 can be extruded toward the front-end | tip protrusion part 4 of the outer cylinder 2. As shown in FIG.

  FIG. 4 is a graph showing temperature control of the medicine chamber 6 in the manufacturing process of the two-chamber prefilled syringe 1 according to the embodiment of the present invention. The horizontal axis of FIG. 4 represents the passage of time, and the vertical axis represents the temperature of the medicine chamber 6. In FIG. 4, the preliminary freezing process of the medicine chamber 6 corresponds to the preliminary freezing process in the manufacturing process of the two-chamber prefilled syringe 1 described above, and the primary drying process and the secondary drying process correspond to the freeze drying process.

  In the preliminary freezing step, the drug chamber 6 initially contains a liquid drug solution 25. By freezing the entire outer cylinder 2 over a predetermined period at a temperature at which the drug solution 25 can be frozen, the drug chamber 6 is frozen, and the drug solution 25 is frozen as a whole inside the drug chamber 6.

  In the primary drying process, the drug chamber 6 is under vacuum, and the solvent starts to sublimate from the drug solution 25. The medicine chamber 6 is heated by a heater 21 disposed around the medicine chamber 6 and can be set to a temperature higher than the freezing temperature in the preliminary freezing step. Thereby, the evaporation of the solvent sublimation from the medicine chamber 6 can be promoted.

  In the secondary drying step, the drug chamber 6 is maintained at a temperature at which the solvent remaining over a predetermined period can be evaporated. Thereby, the solvent in the medicine chamber 6 is evaporated completely.

  In the freeze-drying process corresponding to these primary drying process and secondary drying process, the inner wall of the plunger 13 is frozen by the cooling means 20a and 20b (for example, −50 ° C.). Therefore, the solvent evaporated from the medicine chamber 6 is frozen and held on the inner wall surface of the plunger 13.

  Next, the cooling of the cooling means 20b in the two-chamber prefilled syringe 1 according to the embodiment of the present invention will be described with reference to FIG.

  FIG. 5 is a view for explaining the cooling means according to the embodiment of the present invention. The cooling means 26 can be composed of, for example, a metal tube that is cooled by passage of a refrigerant such as chiller water, a metal rod that reaches the cooling means 20b from the metal tube, and the like. As a result, at least a partial region of the inner wall of the plunger 13 exposed inside the solvent chamber 7 can be cooled to a temperature below the freezing point of the solvent of the chemical solution 25.

Next, another embodiment of the present invention will be described.
FIG. 6 (a) is an explanatory view of a housing step and a preliminary freezing step in a manufacturing process according to another embodiment of the present invention, (b) is an explanatory view of a freeze-drying step, and (c) is an explanatory view of a sealing step. It is. As shown in FIG. 5A, in the present embodiment, the inner cylinder 15 is disposed integrally with the plunger 13 so as to be slidable with respect to the outer cylinder 2. The gasket 14 has an opening 8a at the center through which the valve opening / closing member 13a of the plunger 13 can penetrate. The valve body 8 has a structure for opening and closing the opening 8a of the gasket 14 toward the distal end side.
When the valve body 8 is in contact with the valve opening / closing member 13a formed at the tip of the plunger 13, the valve opening / closing member 13a closes the opening 8a unless the valve opening / closing member 13a operates, and the valve opening / closing member 13a closes the opening 8a. Configured to open.

  When the plunger 13 passes through the opening 8a of the gasket 14, the valve body 8 is in an open state opened to the distal end side. Therefore, for example, the chemical liquid 25 is injected from the proximal end side of the plunger and is stored in the drug chamber 6. Or you may accommodate in a chemical | medical agent chamber from a plunger tip in the sealed state. After the chemical solution 25 is stored in the drug chamber 6, a preliminary freezing step can be performed.

As shown in FIG. 5B, the plunger 13 passes through the opening 8a of the gasket 14, and the valve body 8 is open to the tip side. The solvent evaporated from the drug chamber 6 is held as a frozen solvent 22 on the inner wall of the plunger 13.
As shown in FIG. 5C, the valve opening / closing member 13a is in non-contact with the valve body 8 and liquid-tightly seals the opening 8a as the plunger 13 moves in the proximal direction. Thereby, the medicine chamber 6 and the solvent chamber 7 are isolated from each other.

  As described above, even when the valve body 8 has a structure that opens and closes on the distal end side, the freeze-dried drug 11 and the solvent 22 that has been evaporated and frozen in the freeze-drying are placed in a predetermined space inside the outer cylinder 2. Can be accommodated separately.

FIG. 7 is a diagram illustrating a process of using a two-chamber prefilled syringe according to another embodiment of the present invention, (a) is a diagram illustrating a two-chamber prefilled syringe according to another embodiment of the present invention, and (b) is a diagram illustrating Explanatory drawing of an opening process and a mixing process, (c) is explanatory drawing of a delivery process.
As shown in FIG. 5A, a pusher 10 and a gasket 9 as an outer cylinder sealing member can be attached to the proximal end side of the plunger 13. The pusher 10 slides the pusher 9, the plunger 13, and the inner cylinder 15 toward the tip side. The plunger 13 slides according to the sliding of the pusher 10. The gasket 9 is made of the same material as the gasket 14 and slides inside the outer cylinder 2. The valve body 8 is in a sealed state. The solvent chamber 7 contains the melted solvent 12, and the drug chamber 6 contains the lyophilized drug 11.

  As shown in FIG. 4B, when the gasket 9 is slid to the tip side by pressing the pusher 10, the gasket 9 slides the abutting plunger 13 and inner cylinder 15 to the tip side. When the gasket 9 slides further to the tip side, the tip side of the plunger 13 passes through the opening 8 a of the gasket 14. Thereby, the valve body 8 will be in an open state. Since the drug chamber 6 and the solvent chamber 7 communicate with each other when the valve body 8 is opened, the solvent 12 moves to the drug chamber 6 and comes into contact with the drug 11 to dissolve it, thereby generating a drug solution 25. be able to.

  As shown in FIG. 6C, the gasket 9 further slides the plunger 13 and the inner cylinder 15 toward the tip side by pressing the pusher 10. The inner cylinder 15 abuts on the gasket 14 and slides the gasket 14 to the tip side. Thereby, the gasket 9 and the gasket 14 can slide the chemical | medical agent chamber 6 to the front end side, and can push out the chemical | medical solution 25. FIG.

FIG. 8 is a view showing a manufacturing process of a two-chamber prefilled syringe according to another embodiment of the present invention, (a) is an explanatory view of a storing step and a preliminary freezing step, (b) is an explanatory view of a freeze-drying step, (C) is explanatory drawing of a sealing process and an attachment process.
As shown in FIG. 4A, in this embodiment, the plunger 13 has a cylindrical shape, has a base end opened, a diameter-reduced open end, and is fixed to the gasket 14. . A crosscut having a valve function is provided near the center of the gasket 14. The valve opening / closing member 13b has a cylindrical shape, has a plurality of side holes on the side surface, and contacts the cross cut 18 as a valve body by moving in the cylindrical plunger 13. The cross cut 18 functions as a valve that closes and opens by the valve opening / closing member 13b unless the valve opening / closing member 13b operates.

  When the tip of the valve opening / closing member 13b passes through the cross cut 18, the solvent chamber 7 in the plunger 13 and the drug chamber 6 serving as an inner space on the tip side of the gasket 14 of the outer cylinder 2 communicate with each other. Therefore, for example, the chemical liquid 25 is injected from the proximal end side of the plunger and is stored in the drug chamber 6. Or you may accommodate in a chemical | medical agent chamber from a plunger tip in the sealed state. A heater 21 is disposed outside the medicine chamber 6. Cooling means 20b is provided outside the base end side of the gasket 14 of the outer cylinder 2. After the chemical solution 25 is accommodated in the drug chamber 6, a preliminary freezing step can be performed.

As shown in FIG. 2B, the crosscut 18 is in an open state. The solvent evaporated from the drug chamber 6 is held as a frozen solvent 22 on the inner wall of the plunger 13.
As shown in FIG. 6C, after the freeze-drying step, the valve opening / closing member 13b is pulled up to the proximal end side and separated from the cross cut 18, whereby the cross cut 18 is closed and sealed. A pusher 10 and a gasket 9 are mounted on the proximal end side of the plunger 13. The proximal end side of the plunger 13 is sealed by the gasket 9.

FIG. 9 is a diagram showing a process of using a two-chamber prefilled syringe according to another embodiment of the present invention. (A) is a figure showing the two-chamber prefilled syringe 1 which concerns on other embodiment of this invention, (b) is explanatory drawing of an opening process and a mixing process, (c) is explanatory drawing of a delivery process.
As shown in FIG. 2A, the drug chamber 6 of the outer cylinder 2 stores the freeze-dried drug 11, and the solvent chamber 7 inside the plunger 13 stores the solvent evaporated in the freeze-drying. .

  As shown in FIG. 5B, the tip of the valve opening / closing member 13b penetrates the crosscut 18 by the pressing of the pusher 10. Thereby, the crosscut 18 will be in an open state. Since the drug chamber 6 and the solvent chamber 7 communicate with each other when the crosscut 18 is opened, the solvent 12 moves to the drug chamber 6 and contacts the drug 11 to dissolve it. In this way, the chemical liquid 25 can be generated.

  As shown in FIG. 3C, the plunger 13 and the gasket 14 are slid to the tip side by pressing the pusher 10. Thereby, the gasket 14 can slide the chemical | medical agent chamber 6 to the front end side, and can push out the chemical | medical solution 25. FIG.

  FIG. 10 is a view showing a manufacturing process of a two-chamber prefilled syringe according to another embodiment of the present invention, (a) is an explanatory view of a storing step and a preliminary freezing step, (b) is an explanatory view of a freeze-drying step, (C) is explanatory drawing of a sealing process.

  As shown in FIG. 5A, in the present embodiment, the inside of the outer cylinder 15 slides inside the inner cylinder 15 having the inner cylinder 15 coupled with the gasket 14. The plunger 13 has a cylindrical shape. The plunger 13 is open at the distal end side and the proximal end side. A valve opening / closing member 13c having a reduced diameter is integrally formed at the distal end of the plunger 13, the valve opening / closing member 13c is opened at the distal end side, and the gasket 14 is provided with a cross cut 18 at the center. The cross cut 18 has a function as a valve that is closed and opened by the valve opening / closing member without the action of the valve opening / closing member 13c.

  The valve opening / closing member 13c can penetrate the cross cut 18 of the gasket 14. By penetrating in this way, the solvent chamber 7 inside the plunger 13 and the drug chamber 6 on the distal end side of the outer cylinder 2 communicate with each other. For example, the chemical liquid 25 is injected from the proximal end side of the plunger and is stored in the drug chamber 6. Or you may accommodate in a chemical | medical agent chamber from a plunger tip in the sealed state. A heater 21 is disposed outside the medicine chamber 6. Cooling means 20 a is disposed outside the outer cylinder 2. After the chemical solution 25 is accommodated in the drug chamber 6, a preliminary freezing step can be performed.

As shown in FIG. 2B, the crosscut 18 is in an open state. The solvent evaporated from the drug chamber 6 is held as a frozen solvent 22 on the inner wall of the plunger 13.
As shown in FIG. 3C, after the freeze-drying step, the crosscut 18 is closed and sealed by pulling the plunger 13 to the proximal end side and separating it from the crosscut 18. A pusher 10 and a gasket 9 are attached to the proximal end side of the plunger 13. By mounting the gasket 9, the plunger 13 is held inside the plunger 13 at a position away from the cross cut 18. The plunger 13 is sealed on the proximal end side of the outer cylinder 2 by the gasket 9.

FIG. 11 is a diagram showing a process of using a two-chamber prefilled syringe according to another embodiment of the present invention, (a) is a diagram showing a two-chamber prefilled syringe 1 according to another embodiment of the present invention, and (b). Is an explanatory view of an opening process and a mixing process, and (c) is an explanatory view of a delivery process.
As shown in FIG. 5A, in this embodiment, the lyophilized medicine 11 is accommodated in the medicine chamber 6 in the inner space on the tip side of the gasket 14 of the outer cylinder 2, and the solvent chamber inside the plunger 13. 7 contains the solvent evaporated in the freeze-drying.

  As shown in FIG. 5B, when the pusher 10 is pressed, the valve opening / closing member 13 c moves to the tip side until the pusher 10 contacts the gasket 9 and penetrates the crosscut 18. Thereby, the crosscut 18 will be in an open state. Since the medicine chamber 6 and the solvent chamber 7 communicate with each other when the crosscut 18 is opened, the solvent 12 passes through the plunger 13 and moves to the medicine chamber 6 to come into contact with the medicine 11 and dissolve it. . In this way, the chemical liquid 25 can be generated.

  As shown in FIG. 5C, when the valve opening / closing member 13c is slid to the tip end side by pressing against the pusher 10, the contact portion 13d of the plunger 13 and the contact portion 14b of the gasket 14 contact each other. Further, the gasket 9 and the inner cylinder 15 come into contact with each other, and the gasket 14 can slide the drug chamber 6 toward the tip side to push out the drug solution 25.

  As mentioned above, although the two-chamber type prefilled syringe of the present invention was explained based on an embodiment, the present invention is not limited to this, and each part which constitutes the two-chamber type prefilled syringe of the present invention has the same function. Can be substituted with any structure capable of exhibiting Moreover, arbitrary components may be added.

  In addition, the two-chamber prefilled syringe of the present invention is not limited to those applied to medical drugs, but can also be applied to physics and chemistry experimental apparatuses using physiologically active substances. In the above embodiment, the syringe container includes the outer cylinder 2, the medicine outlet sealing member, the medicine chamber 6, the solvent chamber 7, the gasket 14, the plunger 13, the valve body 8, and the valve opening / closing member 13a.

  The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the above-described embodiments, and various modifications may be made within the scope of the gist of the present invention described in the claims. It can be changed.

  When the two-chamber prefilled syringe according to the present invention is used, it is possible to prevent contamination by introducing a lyophilized drug solution and to quickly generate a drug solution by a simple pressing operation at the site of use. Therefore, the possibility of use in clinical practice is extremely large.

DESCRIPTION OF SYMBOLS 1 2 chamber type prefilled syringe 2 Outer cylinder 3 Taper 4 Tip protrusion part 5 Opening part 6 Drug room (1st chamber)
7 Solvent chamber (second chamber)
8 Valve body 9, 14 Gasket 10 Pusher 11 Drug 12 Solvent 13 Plunger 18 Cross cut 20, 26 Cooling means 21 Heater 25 Chemical liquid

Claims (11)

An outer cylinder having a chemical liquid outlet at the distal end, a chemical liquid outlet sealing portion for sealing the chemical liquid outlet, a first chamber provided at the distal end side in the outer cylinder, and a proximal end side in the outer cylinder. A second chamber, a partition having an opening provided in the outer cylinder, and partitioning the first chamber and the second chamber; an openable / closable valve element provided in the opening; and the inner cylinder A plunger that moves the valve, and a valve opening and closing member that is movable in the axial direction of the outer cylinder within the outer cylinder,
A syringe container, wherein the valve body opens and closes as the valve opening and closing member moves.   The syringe container according to claim 1, wherein the valve opening / closing member is integrally formed at a distal end of the plunger. The plunger has a cylindrical shape,
The syringe container according to claim 1, wherein the valve opening / closing member moves in the plunger lumen.   4. The syringe container according to claim 1, wherein the valve opening / closing member presses the valve body in accordance with the movement in the distal direction, thereby bringing the valve body into a sealed state. 5. .   4. The syringe container according to claim 1, wherein the valve opening member is inserted into the valve body in accordance with movement in a distal direction, thereby bringing the valve body into a released state. 5. The plunger has a cylindrical shape,
The syringe container according to any one of claims 1 to 5, wherein the second chamber is formed in a lumen of the plunger.   The syringe container according to any one of claims 1 to 6, further comprising an inner cylinder having a distal end portion fixed to the partition wall between the outer cylinder and the plunger. The pusher can be attached to the proximal end side of the plunger, and the plunger moves in the outer cylinder in accordance with the movement of the pusher. A prefilled syringe according to 1. A first release state in which the valve body is evaporated by freeze-drying by the valve opening and closing member, and the solvent evaporated in the second chamber is cooled by a predetermined cooling means and frozen. When,
A sealed state in which the frozen solvent is melted in the second chamber;
The prefilled syringe according to any one of claims 1 to 8, wherein the prefilled syringe has a solute contained in the first chamber and a second release state in which the solvent contained in the second chamber is mixed. . The first cylinder includes an outer cylinder, a first chamber provided on a distal end side in the outer cylinder, a second chamber provided on a proximal end side in the outer cylinder, and an opening provided in the outer cylinder. A partition wall partitioning the chamber and the second chamber, an openable / closable valve body provided in the opening, a plunger moving in the outer cylinder, and moving in the outer cylinder in the axial direction of the outer cylinder Accordingly, in a syringe having a valve opening and closing member for opening and closing the valve body,
In the opened state of the valve body, freezing the chemical stored in the first chamber;
In the open state of the valve body, evaporating the solvent of the chemical solution stored in the first chamber, cooling the evaporated solvent by the cooling means provided in the second chamber, and freezing the second chamber; ,
And a step of melting the solvent frozen in the second chamber in the sealed state of the valve body. An outer cylinder having a chemical liquid outlet at the tip; a chemical liquid outlet sealing member that seals the chemical liquid outlet; a first chamber that is provided at a distal end side in the outer cylinder and that stores a lyophilized solute; and A second chamber which is provided on the proximal end side in the cylinder and stores the solvent; a partition which has an opening provided in the outer cylinder and partitions the first chamber and the second chamber; and the opening A syringe having an openable / closable valve body, a plunger that moves in the outer cylinder, and a valve opening / closing member that opens and closes the valve body as the inner cylinder moves in the axial direction of the outer cylinder. In
A method of using a prefilled syringe, wherein the valve element is released by moving the valve opening / closing member, and the solute stored in the first chamber and the solvent stored in the second chamber are mixed.

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