JP5947592B2 - Syringe, piston and syringe for syringe - Google Patents

Description

  The present invention relates to a syringe, a piston for a syringe, and a syringe for a syringe.

  Conventionally, freeze-dried preparations with little decrease in drug activity due to long-term storage have been put into practical use. The lyophilized preparation is used after being dissolved in a liquid. The freeze-dried preparation is distributed in a bottle, for example. In recent years, syringes filled with drugs (drug-filled syringes) filled with drugs such as freeze-dried preparations and powders have come into circulation. As a technique regarding a syringe, it is disclosed by patent document 1, 2, for example.

  When using such a medicine-filled syringe, it is necessary to dissolve the medicine in the syringe with physiological saline or other solution. In this case, in order to dissolve the medicine in the syringe and make the concentration of the medicine in the liquid uniform, in the syringe (specifically, the space in which the medicine inside the syringe is accommodated: called medicine space) Stirring in the presence of a gas such as air. And after discharging | emitting gas, such as air in a medicine space, a chemical | medical solution will be administered (injected) to a human body etc. using a syringe.

  Here, as a method of discharging the gas in the medicine space, the syringe tip or the injection needle attached to the syringe tip is directed upward using the difference in specific gravity between the gas and the liquid, and the gas is discharged from the open end. It was like that. At this time, since it is difficult to discharge only the gas from the drug space, a part of the dissolved drug is also discharged at the same time. In addition, the operator who administers a chemical | medical solution using a syringe has confirmed that there is no gas in a chemical | medical agent space by confirming that a liquid is discharged | emitted from an open end.

JP 2009-142508 A Japanese Patent Laid-Open No. 7-1265421

  As described above, when the gas in the syringe is discharged, it is difficult to discharge only the gas, so that part of the dissolved drug is also discharged at the same time. The syringe is not limited to a drug-filled syringe that requires an operation for dissolving the drug, for example, a syringe that does not require an operation for dissolving the drug, i.e., a container such as a vial bottle or an ampule is used to suck the content liquid with In a syringe that administers to a gas etc., a gas discharge operation similar to the above has been performed because a gas such as air is introduced into the drug space in the syringe during the suction operation of the content liquid. Therefore, even in such a case, the medicine is discharged to the outside. In addition, since the medicine is discharged to the outside in this way, there arises a problem that the external environment is contaminated.

  In addition, for example, when the drug is an anticancer drug or the like, there is a possibility of injury if the spray of the drug contacts the skin. In addition, when the surgeon comes into contact with a drug that is excreted on a daily basis, drug resistance may occur, and this drug may become ineffective. Some drugs contain radioactive substances, and it is necessary to manage them so as to prevent contamination by the discharged drugs.

  In addition, in a weightless environment such as space, there is a problem that the gas discharge operation using the difference in specific gravity between the gas and the liquid as described above cannot be appropriately performed. Further, assuming the use of a syringe in a spacecraft, there is a possibility that the discharge of the chemical solution to the outside may cause corrosion or deterioration of the onboard equipment such as electronic equipment.

  The objective of this invention is providing the technique which can discharge | emit the gas in the medicine space of a syringe easily and appropriately from a medicine space.

To achieve the above object, a syringe according to a first aspect of the present invention includes a cylindrical portion extending in a predetermined direction, a first opening formed at one end of the cylindrical portion in the predetermined direction, A syringe having a second opening formed at the other end of the cylindrical portion in the predetermined direction, and can be accommodated in the cylindrical portion of the syringe from the second opening , A syringe that is slidable in the predetermined direction inside the cylindrical portion, wherein the piston is located at the one end side of the piston when the piston is accommodated in the cylindrical portion. A gas-liquid separation part that allows the gas in the first space to pass therethrough and does not allow the liquid in the first space to pass through the position communicating with the first space, and the gas that has passed through the gas-liquid separation part from the one end side. A first discharge path that can be discharged to the other end side, the first Detchi is openably formed.

  In a preferred embodiment, it has a male thread part for screwing with the piston, and a protrusion formed on the one end side of the male thread part, and is attached to the other end side of the piston, You may further have a plunger rod which slides a piston. The piston includes an internal thread portion for screwing with the external thread portion of the plunger rod from the other end side, a second space on the other end side of the gas liquid separation portion, and the other end. A cylindrical third space having an opening, and an opening / closing portion that opens and closes the first discharge path in a communication state between the second space and the third space at a position corresponding to the protrusion. You may have. The opening / closing portion closes the first discharge path by blocking communication between the second space and the third space when the protrusion is at the first position in the predetermined direction with respect to the piston. When the protrusion is inserted to the piston to the second position closer to the one end than the first position, the second space and the third space are brought into contact with the protrusion. When the first discharge path is opened by forming a through-hole that communicates with the piston, and the protrusion is inserted into the piston to the third position closer to the one end than the second position, By fitting with the protrusion, the communication between the second space and the third space may be blocked and the first discharge path may be closed.

  In a preferred embodiment, the opening / closing portion is formed with a slit whose length in a predetermined direction does not penetrate to one end side at a position where the opening / closing portion comes into contact with the other end side protruding portion, and the protruding portion on one end side. A fitting portion having a shape to be fitted may be formed.

  In a preferred embodiment, a medicine may be accommodated on one end side of the piston in the cylindrical portion.

  In a preferred embodiment, the piston may have a second discharge path that guides the gas that has passed through the gas-liquid separator from one end side to the outer periphery of the piston in a direction that intersects the predetermined direction.

  To achieve the above object, a syringe according to a second aspect of the present invention includes a cylindrical portion extending in a predetermined direction, a first opening formed at one end of the cylindrical portion in the predetermined direction, A syringe having a second opening formed at the other end of the cylindrical portion in the predetermined direction, and can be accommodated in the cylindrical portion of the syringe from the second opening, A syringe that is slidable in the predetermined direction inside the cylindrical portion, wherein the piston is located at the one end side of the piston when the piston is accommodated in the cylindrical portion. A gas-liquid separation part that allows the gas in the first space to pass therethrough and does not allow the liquid in the first space to pass through the position communicating with the first space, and the gas that has passed through the gas-liquid separation part from the one end side. Guide to the outer periphery of the piston in a direction that intersects the predetermined direction Has a second discharge path, the.

  In a preferred embodiment, when the piston is inserted to a predetermined position in a predetermined direction of the syringe, the second discharge path may be sealed by the inner surface of the cylindrical portion of the syringe.

In order to achieve the above object, a syringe piston according to a third aspect of the present invention has a cylindrical portion extending in a predetermined direction, an injection needle can be attached to one end side in the predetermined direction, and the other end A syringe piston that can be accommodated in a syringe having an opening formed on the side thereof, and allows gas in the first space to pass therethrough and liquid in the first space not to pass through a position communicating with the first space on one end side. A gas / liquid separation part; and a first discharge path capable of discharging the gas that has passed through the gas / liquid separation part from the one end side to the other end side, wherein the first discharge path is formed to be openable and closable. The

  In order to achieve the above object, a syringe piston according to a fourth aspect of the present invention has a cylindrical portion extending in a predetermined direction, and an injection needle can be attached to one end side in the predetermined direction and the other end. A syringe piston capable of being accommodated in a syringe having an opening formed on the side thereof, wherein the gas in the first space is passed to a position communicating with the first space on the one end side and the liquid in the first space And a second discharge path that guides the gas that has passed through the gas-liquid separator from the one end side to the outer periphery of the piston in a direction that intersects the predetermined direction.

It is a figure which shows the structure of the syringe which concerns on the 1st Embodiment of this invention. It is a block diagram of the gasket and filter unit which concern on the 1st Embodiment of this invention. It is a figure explaining the structure of the piston which concerns on the 1st Embodiment of this invention, and the state change of a piston. It is a figure explaining the usage method of the syringe which concerns on the 1st Embodiment of this invention. It is a figure explaining the manufacturing method of the syringe which concerns on the 1st Embodiment of this invention. It is a block diagram of the gasket and filter unit which concern on the modification of this invention. It is a block diagram of the syringe which concerns on the 2nd Embodiment of this invention. It is a partial cross section near the front-end | tip of a syringe at the time of chemical | medical agent storage. It is sectional drawing of the back | latter stage part in which the groove part is provided. It is FF sectional drawing of a piston accommodating part. It is a figure explaining the usage method of the syringe which concerns on the 2nd Embodiment of this invention.

  Embodiments of the present invention will be described with reference to the drawings. The embodiments described below do not limit the invention according to the claims, and all the elements and combinations described in the embodiments are essential for the solution of the invention. Is not limited.

  A syringe according to an embodiment of the present invention will be described.

  FIG. 1 is a diagram showing a configuration of a syringe according to the first embodiment of the present invention. Fig. 1 (1) is an external view of the syringe 10 when the drug is stored (during drug storage), Fig. 1 (2) is a partial cross-sectional view of the syringe 10, and Fig. 1 (3) FIG. 1 is an external view of the plunger rod 20 of the syringe 10, FIG. 1 (4) shows a double-edged needle attached to the syringe 10, and FIG. 1 (5) shows a general needle attached to the syringe 10. .

  As shown in FIG. 1 (1), the syringe 10 has a syringe 30 including a substantially cylindrical tubular portion 30a formed extending in a predetermined direction (the vertical direction in FIG. 1). A first opening 31 a is formed at one end of the syringe 30 in a predetermined direction, and a second opening 31 b is formed at the other end of the syringe 30 in the predetermined direction. The chemical solution is discharged from the first opening 31a. The piston 40 is inserted into the cylindrical portion 30a from the second opening 31b. The syringe 30 is made of, for example, glass or plastic. For example, the plastic material preferably has no or little eluate with respect to the medicine or the like contained in the syringe 30.

  Inside the cylindrical portion 30a of the syringe 30, a piston 40 that is slidable in the vertical direction of the drawing while being in contact with the inner surface of the cylindrical portion 30a is accommodated. The piston 40 has a gasket 50 and a filter unit 60. The gasket 50 and the filter unit 60 will be described later.

  A drug space S (first space) in which the drug M is accommodated is defined on one end side in the predetermined direction of the piston 40 in the syringe 30 (lower side in the drawing: hereinafter also referred to as the front end side). During drug storage before using the syringe 10, the drug space S may contain gas in addition to the drug M.

  A plunger rod 20 that is operated when an operator using the syringe 10 slides the piston 40 is attached to the other end side in the predetermined direction of the piston 40 (upper side of the drawing: hereinafter also referred to as a rear end side). .

  As shown in FIG. 1 (3), the plunger rod 20 is connected to the piston 40 on the side connected to the piston 40, and the distal end side along the central axis of the plunger rod 20. And a substantially cylindrical protrusion 22 extending in the direction.

  As shown in FIG. 1B, a check valve 90 that stops the liquid stored in the medicine space S from flowing out from the tip of the syringe 30 is disposed at the tip in the cylindrical portion 30 a of the syringe 30. . The check valve 90 is made of, for example, silicon rubber. In the vicinity of the central axis X of the check valve 90, as shown in FIG. 1 (2), when the drug solution is administered to the administration target by the syringe 10, the drug solution in the drug space S can be administered. The opening part 90a penetrated by the inner needle 102 of the double-edged needle 100 shown in FIG.

  A distal tip 70 to which an injection needle (the double-edged needle 101, the general needle 110, etc. in FIGS. 1 (4) and (5)) can be attached and detached is attached to the outer peripheral portion of the front stage 30b on the distal end side of the syringe 30. A male luer is formed at the tip of the tip 70. The tip 70 is made of, for example, polyphenyl sulfide (PPS) that has high resistance to low temperatures.

  The distal tip 70 is fitted with a distal cap 80 that hermetically protects the peripheral portion where the injection needle of the distal tip 70 is attached and the inner surface of the distal tip 70 through which the drug passes. The tip cap 80 is made of rubber, for example. The distal end cap 80 is removed from the distal end tip 70 when the syringe 10 is prepared for use.

  As the injection needle connected to the distal tip 70, there are a double-edged needle 101 shown in FIG. 1 (4) and a general needle 110 shown in FIG. 1 (5). The double-edged needle 101 is an injection needle used to administer a drug solution to an administration subject such as a person, and has an outer needle 101 inserted into the administration subject on one side and a check valve 90 on the other side. The inner needle 102 is inserted into the opening portion 90a. The general needle 110 is an injection needle used to introduce a solution for dissolving a drug into the drug space S, and is inserted into a container (for example, a vial bottle) containing the solution on one side. An outer needle 111 is provided.

  FIG. 2 is a configuration diagram of the gasket and the filter unit according to the first embodiment of the present invention. 2 (1) is an external view of the gasket 50 as viewed from the rear end side, FIG. 2 (2) is an AA sectional view of the gasket 50, and FIG. 2 (4) is an external view of the filter unit 60 viewed from the rear end side, and FIG. 2 (5) is a cross-sectional view of the filter unit 60 taken along the line BB.

  The gasket 50 is made of an elastic material such as chlorinated butyl rubber, silicon rubber, or fluorine rubber. The material of the gasket 50 is preferably a material that has no or little eluate with respect to the medicine or the like contained in the syringe 30. The material of the gasket 50 is not limited to rubber as long as it satisfies the airtightness and sliding characteristics required in the syringe 10, and may be, for example, polypropylene or polyethylene, or other plastics. Also good.

  The gasket 50 has a shape that the outer peripheral surface is in contact with the inner peripheral surface of the cylindrical portion 30a of the syringe 30 and the drug space S is not released to the rear end side between the gasket 50 and the cylindrical portion 30a. . Specifically, the maximum radius of the outer periphery of the gasket 50 when not accommodated in the syringe 30 is slightly larger than the inner radius of the cylindrical portion 30 a of the syringe 30.

  A female thread portion 52 corresponding to the male thread portion 21 of the plunger rod 20 is formed on the inner peripheral surface of the gasket 50 on the rear stage side.

  As shown in FIG. 2A, a straight slit 53 is formed on the bottom surface 51 of the female threaded portion 52 of the gasket 50 when viewed from the rear end side. The length of the slit 53 in the central axis direction is a length that does not penetrate the front end side of the gasket 50 when the medicine is stored in the syringe 10 as shown in FIG. That is, the gasket 50 includes a blocking portion 56 that blocks communication between the front end side and the rear end side. As will be described later, when the syringe 10 is prepared for use, the blocking portion 56 is broken so that the front end side and the rear end side communicate with each other to open the discharge path (first discharge path).

  On the front end side surface of the gasket 50, there is a space 57 having a shape (a columnar shape having a diameter slightly smaller than the diameter of the protrusion 22 in the present embodiment) in which the protrusion 22 of the plunger rod 20 is fitted on the central axis. A formed sealing portion 54 is provided. Therefore, when the protruding portion 22 breaks the blocking portion 56 of the gasket 50 and is further inserted into the front end side, the protruding portion 22 is fitted with the sealing portion 54, and the front end side and the rear end side The communication of the space can be cut off. Here, the blocking part 56 and the sealing part 54 constitute an opening / closing part.

  The gasket 50 may be configured without the blocking portion 56. That is, the slit 53 may penetrate from the rear end to the front end of the gasket 50. Even in this case, when the protrusion 22 is not inserted into the slit, the communication between the front end side and the rear end side is substantially blocked by the elasticity of the gasket 50.

  Further, a discharge path 55 (second discharge path) extending from the central axis to the outer periphery of the gasket 50 is formed on the distal end side of the gasket 50. The discharge path 55 communicates with a space 57 inside the sealing portion 54. In the present embodiment, as shown in FIG. 2 (3), three discharge paths 55 are formed at the same angle around the central axis. In addition, the number of the discharge paths 55 may be arbitrary.

  The filter unit 60 includes a gas-liquid separation membrane 64 as an example of a gas-liquid separation portion, support members 61, 62, and 63 for supporting the gas-liquid separation membrane 64, and an outer peripheral portion 65 that accommodates these members. .

  The gas-liquid separation membrane 64 is a membrane having a property that gas is easy to pass but liquid is difficult to pass. That is, the gas-liquid separation membrane 64 has a property that the flow path resistance to the liquid is larger than that of the gas. The material of the surface on the drug space S side of the gas-liquid separation membrane 64 is preferably a highly water-repellent material such as Teflon (registered trademark) when a water-based drug is accommodated in the drug space S, for example. This prevents clogging of the micropores formed in the membrane without causing water absorption into the gas-liquid separation membrane 64 when the freeze-dried medicine M and the solution are mixed in the medicine space S. This is because the subsequent gas-liquid separation can be performed effectively. The gas-liquid separation membrane 64 is preferably one that has a small amount of liquid absorption and a small amount of drug component adsorption. Further, the diameter of the fine holes formed in the gas-liquid separation membrane 64 may be a nominal hole diameter of 0.22 μm or less. In this way, it is possible to appropriately prevent bacteria from passing through the gas-liquid separation membrane 64. In the present embodiment, the gas-liquid separation membrane 64 has a disc shape.

  The support members 61, 62, and 63 are made of plastic, for example. In this embodiment, the gas-liquid separation membrane 64 is sandwiched between the substantially O-shaped support member 61 on the front end side and the support members 62 and 63 on the rear end side, and in this state, the support member 61, the support member 62, 63 is welded. As a method of welding the supporting members 61, 62, and 63, a method using heat, ultrasonic waves, or the like can be used.

  As shown in FIG. 2 (5), the gas-liquid separation membrane 64 supported by the support members 61, 62, and 63 has one surface facing the front end side (that is, the drug space S) and the other surface being the rear end. Arranged to face side.

  The support member 63 has a contact preventing portion 63a for preventing the protrusion 22 of the plunger rod 20 from contacting the gas-liquid separation membrane 64 on the central axis. The support member 63 has a through hole 67 for communicating the space 68 (second space) on the rear end side of the gas-liquid separation membrane 64 with the space 57 inside the discharge path 55 and the sealing portion 54. Is formed. In the present embodiment, as shown in FIG. 2 (4), three through holes 67 are formed in the support member 63 at the same angle around the central axis. The number of through holes 67 may be an arbitrary number. In the present embodiment, the through-hole 67 of the filter unit 60 and the discharge passage 55 of the gasket 50 are communicated with the space 57 inside the sealing portion 54, respectively. No alignment between 67 and the discharge path 55 is necessary.

  The outer peripheral portion 65 is made of an elastic material such as chlorinated butyl rubber, silicon rubber, or fluoro rubber. The outer peripheral portion 65 accommodates support members 61, 62, and 63 that support the gas-liquid separation membrane 64 on the inner surface side. The outer peripheral portion 65 has a shape for preventing the medicine space S from being released to the rear end side between the outer peripheral surface and the cylindrical portion 30a by contacting the inner surface of the cylindrical portion 30a of the syringe 30. . Specifically, the maximum radius of the outer periphery of the outer peripheral portion 65 when not accommodated in the syringe 30 is slightly larger than the inner radius of the cylindrical portion 30 a of the syringe 30.

  Drawing 3 is a figure explaining the composition of the piston concerning the 1st embodiment of the present invention, and the change of the state of a piston. FIG. 3 (1) shows the state at the time of medicine storage, FIG. 3 (2) shows the state at the time of gas discharge from the medicine space S after dissolving the medicine, and FIG. 3 (3) shows the medicine space. The state just before use of the syringe 10 after the gas discharge | emission from S is shown. In addition, in the figure, illustration is abbreviate | omitted about the syringe 30 which accommodates the gasket 50 in the inside.

  At the time of drug storage, as shown in FIG. 3A, the drug space S and the space 68 are connected via the gas-liquid separation membrane 64. Communicating with Further, the space 68 communicates with the space 57 and the discharge path 55 through a through hole 67. In addition, the state of communication of the medicine space S, the space 68, the space 57, and the discharge path 55 is determined when the gas is discharged from the medicine space S shown in FIG. 3 (2) and from the medicine space S shown in FIG. 3 (3). It is the same state just before use of syringe 10 after gas discharge.

  The axial position of the protrusion 22 of the plunger rod 20 is a position (first position) that does not contact the bottom surface 51 of the gasket 50. When the protruding portion 22 is in this position, the blocking portion 56 of the gasket 50 is in an initial state, that is, a state in which it is not broken. Therefore, the space 57 does not communicate with the space 59 (third space) on the rear end side of the bottom surface 51 of the gasket 50. That is, the exhaust path through which the gas that has passed through the gas-liquid separation membrane 64 can be discharged to the rear end side is closed. Therefore, the medicine space S is secured in a sealed state.

  On the other hand, at the time of gas discharge from the medicine space S after dissolving the medicine, the plunger rod 20 is pivoted in the axial direction of the protrusion 22 of the plunger rod 20 as shown in FIG. The position is moved by a predetermined amount from the bottom surface 51 to a position on the tip side (second position). As a result, the protruding portion 22 is inserted into the slit 53 of the gasket 50, and the blocking portion 56 is broken. As a result, the space 57 and the space 59 on the rear end side of the bottom surface 51 communicate with each other via the space 58 around the protrusion 22. Further, the space 59 communicates with an external space through a space between the female screw portion 52 of the gasket 50 and the male screw portion 21 of the plunger rod 20. Therefore, regarding the gas, the medicine space S communicates with the external space, and the discharge path (first discharge path) is open. Thereby, by depressing the plunger rod 20 in the distal end direction, the gas present in the medicine space S can be discharged outside through the gas-liquid separation membrane 64.

  Further, immediately before the use of the syringe 10 after the gas is discharged from the medicine space S, as shown in FIG. 3 (3), the plunger rod 20 is further swung, and the axial direction of the protrusion 22 of the plunger rod 20. Is moved further to the front end side than the bottom surface 51, and the protrusion 22 is moved to a position (third position) where it reaches the sealing portion 54 of the gasket 50. As a result, the protrusion 22 is fitted into the sealing portion 54. For this reason, the communication between the space 57 and the space 59 on the rear end side of the bottom surface 51 is blocked. That is, the exhaust path through which the gas that has passed through the gas-liquid separation membrane 64 can be discharged to the rear end side is closed. Thereby, the medicine space S is sealed.

  FIG. 4 is a diagram for explaining a method of using the syringe according to the first embodiment of the present invention.

  When using the syringe 10, first, as shown in FIG. 4 (1), the storage bag 180 of the syringe 10 in the storage state (for example, the state of FIG. 5 (6)) is opened, and the tip cap 80 is removed. The general needle 110 is attached to the tip 70.

  Next, as shown in FIG. 4 (2), the general needle 110 is removed from the rubber stopper Ra of the enclosing container R in which a solution for dissolving the drug M (for example, saline solution) is enclosed. By inserting the needle 111 and pulling out the plunger rod 20 to the rear end side, the piston 40 is slid and moved to the rear end side, and the solution in the enclosed container R is sucked into the drug space S. Note that the direction in which the solution flows in is opposite to the direction in which the flow of the check valve 90 is stopped, so that the solution is guided into the drug space S.

  Thereafter, as shown in FIG. 4 (3), the general needle 110 is removed, and the syringe 10 is swung to sufficiently stir the drug M and the solution. Thereby, the solution (drug solution) of the medicine to be administered is completed. Note that gas is present in the medicine space S.

  Next, as shown in FIG. 4 (4), the plunger rod 20 is turned by a predetermined amount, and the protrusion 22 of the plunger rod 20 is moved to the position shown in FIG. 3 (2). Thereby, by depressing the plunger rod 20 toward the distal end side, the gas present in the medicine space S can pass through the gas-liquid separation membrane 64 and be discharged to the outside.

  Next, as shown in FIG. 4 (5), the plunger rod 20 is moved in the distal direction until it does not move easily. As a result, the gas in the drug space S on the tip side of the gas-liquid separation membrane 64 is discharged to the outside. At this time, since the liquid does not pass through the gas-liquid separation membrane 64, the liquid is not discharged to the outside. Thereafter, the plunger rod 20 is turned by a predetermined amount, and the protrusion 22 of the plunger rod 20 is moved to the position shown in FIG. Thereby, the medicine space S is in a sealed state.

  Thereafter, as shown in FIG. 4 (6), the double-edged needle 100 is attached to the tip 70. As a result, the inner needle 102 of the double-edged needle 100 passes through the opening 90 a of the check valve 90 and reaches the medicine space S. Thereafter, by inserting the outer needle 101 of the double-edged needle 100 into the administration subject and moving the plunger rod 20 to the distal end side, the drug solution can be administered to the administration subject.

  FIG. 5 is a view for explaining the method for manufacturing the syringe according to the first embodiment of the present invention.

  First, as shown in FIG. 5A, the syringe 30 to which the distal end cap 80 and the distal end tip 70 are attached is disposed on the fixture 150, and a liquid medicine is injected into the syringe 30.

  Next, as shown in FIG. 5 (2), the piston 40 is held by the holder 160, and the piston 40 is fitted into the rear end side of the syringe 30. At this time, the piston 40 is fitted to a position where the discharge path 55 does not face the inner wall surface of the syringe 30. In this state, the liquid does not flow out to the outside due to the gas-liquid separation film 64 of the piston 40.

  Next, the syringe 30 in the state shown in FIG. 5 (2) is placed on a predetermined fixture 170 in a freeze dryer having a predetermined degree of vacuum as shown in FIG. 5 (3). And freeze-dry the drug. Thereby, the gas (including water vapor) in the medicine space S is discharged through the discharge path 55.

  And when freeze-drying of a medicine is completed, as shown in Drawing 4 (4), in the state where a vacuum state was maintained in a freeze dryer, discharge passage 55 will be in the position which counters the inner wall surface of syringe 30. The piston 40 is fitted to the end. Thereby, the medicine space S is sealed in a vacuum state.

  Next, as shown in FIG. 5 (5), when the inside of the freeze dryer is opened to the atmosphere, the atmospheric pressure is received, and the piston 40 of the syringe 30 slides toward the tip side. In FIG. 5 (5), there is a space other than the drug M in the drug space S. This is a space where there is a gas remaining according to the vacuum state (degree of vacuum) in FIG. 5 (4). is there.

  Thereafter, as shown in FIG. 5 (6), after the plunger rod 20 is screwed onto the piston 40, the syringe 10 is housed in the housing bag 180. The plunger rod 20 is screwed into the piston 40 such that the plunger 22 is in the state shown in FIG. 3A, that is, the protrusion 22 of the plunger rod 20 is not in contact with the bottom surface 51 of the gasket 50. In the present embodiment, the plunger rod 20 is screwed and then accommodated in the accommodation bag 180. However, the plunger rod 20 may be accommodated in the accommodation bag 180 without being screwed.

  Next, a modification of this embodiment will be described.

  The modified example is different from the above-described embodiment in the configuration of the piston.

  FIG. 6 is a configuration diagram of a gasket and a filter unit according to a modification of the present invention. 6A is an external view of the filter unit 220 as viewed from the rear end side, FIG. 6B is a cross-sectional view taken along the line C-C of the filter unit 220, and FIG. FIG.

  The piston 200 according to the modification includes a gasket 210 and a filter unit 220 as shown in FIG. The gasket 210 differs from the gasket 50 of the above-described embodiment only in that the shape of the portion connected to the filter unit 220 is different and that no exhaust path is formed, and the other portions are the same.

  The filter unit 220 includes a gas-liquid separation membrane 223 as an example of a gas-liquid separation unit, and support members 221 and 222 for supporting the gas-liquid separation membrane 223.

  The gas-liquid separation membrane 223 is the same as the gas-liquid separation membrane 64 of the above embodiment. The support member 222 is the same as the support member 63 of the above embodiment. The support member 221 includes a substantially cylindrical member and a flange portion 221a formed to extend around the entire periphery thereof. The support member 221 is made of plastic, for example. In the present embodiment, the support member 221 is formed with a plurality of (two in the drawing) flange portions 221a in the axial direction. The maximum radius of the outer periphery of the flange portion 221a in a state where it is not accommodated in the syringe 30 is slightly larger than the inner radius of the cylindrical portion 30a of the syringe 30, and when accommodated in the syringe 30, The drug space S is prevented from being released to the rear end side by contact with the inner peripheral surface of the cylindrical portion 30a and a gap with the cylindrical portion 30a.

  The opening on the front end side of the support member 221 is formed narrower than the opening on the rear end side. The gas-liquid separation membrane 223 is disposed on the rear end side with respect to the opening on the front end side of the support member 221, and is sandwiched between the support member 221 and the support member 222. The support member 221 and the support member 222 are welded. With such a configuration, the space (drug space S) on the distal end side of the gas-liquid separation membrane 223 and the space 226 are arranged via the gas-liquid separation membrane 223. The space 226 communicates with the space 227 on the rear end side of the support member 222 through the through hole 225.

  Further, a notch 221b extending in the axial direction is formed on the wall surface on the rear end side of the support member 221. For example, the notches 221b are formed at four locations. By this cutout part 221b, a discharge path 228 is formed which is connected from the space 227 through the cutout part 221b in the outer peripheral direction.

  According to this modification, the number of members necessary for the filter unit 220 can be reduced, and the manufacturing cost can be reduced.

  In said 1st Embodiment, the gas liquid separation part is provided in a piston and the structure which can discharge | emit the gas inside a cylinder from the rear end of a piston is employ | adopted. On the other hand, in the second embodiment described below, a gas / liquid separation part is provided not on the piston but on the tip side inside the syringe, so that gas can be discharged from the tip of the syringe. Hereinafter, although the second embodiment will be described, the same components as those of the first embodiment may be denoted by the same reference numerals and description thereof may be omitted.

  FIG. 7 is a configuration diagram of a syringe and a plunger rod constituting the syringe 300 according to the second embodiment of the present invention.

  FIG. 7A is a cross-sectional view of the syringe 310 constituting the syringe 300 at the time of medicine storage, and FIG. 7B is the plunger rod 315 of the syringe 300. The syringe 310 has a cylindrical portion 320 formed to extend in a predetermined direction. A first opening 321 is formed at one end of the syringe 310 in a predetermined direction, and a second opening 311 is formed at the other end of the syringe 30 in the predetermined direction. The syringe 310 is made of, for example, glass or plastic. The plastic material preferably has no or little eluate with respect to, for example, the medicine accommodated in the syringe 310. As shown in FIG. 7B, the plunger rod 315 has a male thread portion 315a for connecting to the third piston 330c on the side connected to the piston third piston 330c.

  As shown in FIG. 7A, a double chamber syringe is employed in this embodiment. As is well known, the double chamber-syringe is a syringe in which two chambers are formed by a cylindrical portion of the syringe and a plurality of pistons in the space inside the syringe 310.

  The substantially cylindrical tubular portion 320 of the syringe 310 according to the present embodiment includes a front-stage portion 320a, a middle-stage portion 320b, and a rear-stage portion 320c from the front end side. The tip tip 70 and the tip cap 80 are attached to the outer peripheral portion on the tip end side of the front step portion 320a as in the first embodiment. The inner radius of the front step portion 320a is smaller than the inner radius of the middle step portion 320b. As will be described later, the first piston 330a can be accommodated in the middle stage portion 320b. The second and third pistons can slide inside the rear stage part 320c. The inner radius of the middle step portion 320b is smaller than the inner radius of the rear step portion 320c.

  The material and function of the syringe 310 are the same as the material and function of the syringe of the first embodiment.

  FIG. 8 is a partial cross-sectional view of the vicinity of the tip of the syringe 310 at the time of drug storage as in FIG. 7 (1). Hereinafter, the configuration of the syringe 310 will be described in detail with reference to FIG. 7A and FIG.

  When a chemical solution is administered to an administration target, the chemical solution in the cylindrical portion 320 is discharged from the first opening 321 formed at the tip of the front stage portion 320a. A disc-shaped gas-liquid separation membrane 400 is disposed at the front end of the front stage portion 320a so as to close the opening 321. The material and function of the gas-liquid separation membrane 400 are the same as those in the first embodiment.

  A gasket 390 is disposed between the tip tip 70 on the tip side of the gas-liquid separation membrane 400. The gasket 390 is formed with a guide hole 391 for allowing the inner needle 102 to pass when the double-edged needle 100 is attached to the distal tip 70. The gasket 390 is made of an elastic material such as chlorinated butyl rubber, silicon rubber, or fluorine rubber. Furthermore, the material of the gasket 390 is not limited to rubber, and may be, for example, polypropylene or polyethylene, or other plastics.

  The gas-liquid separation membrane 400 is fixed by the gasket 390 and the tip 70. That is, the engaging portion 71 formed on the inner side of the rear end of the tip chip 70 and the engaging portion 322 on the outer peripheral surface of the front step portion 320a are engaged, whereby the gasket 390 is pushed in the vertical direction, and the pressing force is increased. Due to the repulsive force, the gas-liquid separation membrane 400 comes into close contact with the front end surface of the front stage part 320a, and the opening at the front end of the front stage part 320a is covered.

  In the present embodiment, the first piston 330a, the second piston 330b, and the third piston 330c are housed inside the syringe 310. Each piston 330a-c is comprised with the gasket, respectively.

  As shown in FIGS. 7A and 8, the first piston 330a is located at the boundary between the middle stage portion 320b and the rear stage portion 320c. The second piston 330b is located in the rear stage portion 320c on the rear end side with respect to the position of the first piston 330a. The third piston 330c is located in the rear stage portion 320c on the rear end side with respect to the position of the second piston 330b. A first chamber 340a is formed between the first piston 330a and the second piston 330b, and a second chamber 340b is formed between the second piston 330b and the third piston 330c. A third chamber is formed on the distal end side of the first piston 330a. The first chamber 340a contains a lyophilized medicine M, and the second chamber 340b contains a solution L such as saline. The first chamber 340a and the second chamber 340b may contain gas in addition to the drug M and the solution L, respectively. The third chamber 340c contains gas.

  As shown in FIG. 8, the first piston 330 a has a body portion 331 and a flange portion 332. In a state where the syringe 310 is not accommodated, the maximum radius of the outer periphery of the body portion 331 is slightly larger than the inner radius of the middle step portion 320b, and the maximum radius of the outer periphery of the flange portion 332 is larger than the inner radius of the rear step portion 320c. Slightly larger. The thickness of the first piston 330a is shorter than the length of the middle step portion 320b. When the first piston 330a is disposed at the position shown in FIG. 8, that is, when the body portion 331 is accommodated in the middle step portion 320b and the flange portion 332 is located in the rear step portion 320c, the outer peripheral surface of the body portion 331 is The contact between the first chamber 340a and the third chamber 340c is blocked by contacting the inner peripheral surface of the middle step portion 320b and the outer peripheral surface of the flange portion 332 contacting the inner peripheral surface of the rear step portion 320c. When the first piston 330a moves to a position where it is completely accommodated in the middle step part 320b, the flange part 332 is deformed so as to rise along the inner wall. At this time, as will be described in detail later, the first chamber 340a and the third chamber 340c communicate (see FIG. 11 (4)).

  The second piston 330b has a shape for preventing the first chamber 340a and the second chamber 340b from communicating with each other between the outer peripheral surface of the second piston 330b and the inner peripheral surface of the rear stage part 320c of the syringe 310. Have. For example, the maximum radius of the outer periphery of the second piston 330b when not accommodated in the syringe 310 is slightly larger than the inner radius of the rear stage portion 320c.

  The third piston 330 c has a shape for preventing the second chamber from opening to the rear end side of the syringe 310 by contacting the inner peripheral surface of the rear stage part 320 c of the syringe 310 with the outer peripheral surface. For example, the maximum radius of the outer periphery of the third piston 330c in a state where it is not accommodated in the syringe 310 is slightly larger than the inner radius of the rear stage portion 320c. The third piston 330c has a cylindrical lumen with an open rear end, and an internal thread portion 335 corresponding to the male thread portion 315a of the plunger rod 315 is formed on the inner wall thereof.

  The material and function of each piston 330a-c are the same as the material and function of the gasket of the first embodiment.

  In the rear stage part 320c, a groove part 350a is provided between positions where the first piston 330a and the second piston 330b are respectively arranged.

  9 (1) is a DD cross-sectional view of the rear stage portion 320c provided with the groove 350a, and FIG. 9 (2) is an EE cross-section when the second piston 330b is moved to the position of the groove 350a. FIG.

  As shown in FIG. 7 (1) and FIG. 9 (1), a liquid passage projecting outward is formed on the inner surface of the syringe 310 slightly from the tip of the position where the second piston 330b is disposed. A groove 350a is formed. The length of the groove 350a in the predetermined direction is slightly longer than the thickness of the second piston 330b. That is, as shown in FIG. 9 (2) and FIG. 11 (2) described later, when the second piston 330b moves to the position of the groove 350a, the first chamber 340a and the second chamber blocked by the second piston 330b. 340b communicates with the groove 350a. In the present embodiment, the number of the groove portions 350a is one, but a plurality of grooves may be provided.

  FIG. 10A is a cross-sectional view taken along the line FF of the middle step portion 320b, and FIG. 10B is a cross-sectional view taken along line GG when the first piston 330a is completely accommodated in the middle step portion 320b.

  As shown in FIGS. 7 (1) and 10 (1), on the inner surface of the middle step portion 320b, a rod-like protrusion portion 350b is formed that protrudes inward from the front end to the rear end. FIG. 10B is a cross-sectional view when the first piston 330a is accommodated in the middle step portion 320b. As shown in FIG. 10 (2) and FIG. 11 (4) described later, when the first piston 330a is accommodated in the middle step portion 320b, the outer periphery of the first piston 330a is caused by the elastic force of the rubber constituting the first piston 330a. The surface and the inner surface of the middle step portion 320b are in close contact with each other. However, since the rubber which comprises the 1st piston 330a has hardness more than predetermined, rubber | gum does not protrude until it covers all the bottom parts 351 of the projection part 350b. Therefore, a slight gap 352 in which the first piston 330a does not enter is formed in the skirt 351. At this time, when the first piston 330a is completely accommodated in the middle step portion 320b, the flange portion 332 rises along the inner wall of the middle step portion 320b due to elasticity. As a result, the shielding formed by the rear stage part 320c and the flange part 332 is released, and the first chamber 340a and the third chamber 340c communicate with each other through the gap 352 shown in FIG. In the present embodiment, the protrusions 350b are provided at two locations, but may be provided at one location or three or more locations.

  Since the manufacturing method of the double chamber syringe with which the medicine M and the solution L shown in FIG. 7 are enclosed is well known as described in, for example, Patent Document 2, description thereof is omitted.

  FIG. 11 is a diagram for explaining a method of using the double chamber-syringe according to the present embodiment. In the drawing, the display of the plunger rod 315 attached to the rear end side of the third piston 330c is omitted.

  FIG. 11 (1) shows the state when the medicine is stored. From here, as shown in FIG. 11 (2), the third piston 330c is pushed to the position of the groove 350a with a plunger rod (not shown) to the tip side. In the state of FIG. 11 (2), the first chamber 340a and the second chamber 340b communicate with each other through the groove 350a, so that the solution L in the second chamber 340b is sent into the first chamber 340a. Here, by sufficiently stirring the drug M and the solution L, as shown in FIG. 11 (3), a drug solution (drug solution) to be administered is completed in the first chamber 340a.

  At this time, gas is present in one or both of the first chamber 340a and the second chamber 340b. Therefore, the tip of the syringe 310 is directed upward, and the tip cap 80 is removed or slightly loosened so that gas can be discharged from the tip of the tip tip 70, and the third piston 330c is further pushed through the plunger rod. Go. Then, as shown in FIG. 11 (4), all the gas in the second chamber moves to the first chamber 340a through the groove 350a, and the second chamber 340b disappears. At the same time, the first piston 330a is pushed, and the gas in the third chamber 340c that has passed through the gas-liquid separation membrane 400 is discharged from the tip of the tip 70, and the first piston 330a moves to the tip side. To do. As shown in FIG. 11 (4), when the first piston 330a is completely accommodated in the middle stage portion 320b, the first chamber 340a and the third chamber 340c communicate with each other. At this time, since the gas-liquid separation membrane 400 does not pass the liquid, the medicine is not discharged from the tip of the tip tip 70. Here, when the third piston 330 c is further pushed, the remaining gas in the syringe 310 is discharged from the tip of the tip tip 70 through the gas-liquid separation film 400. As a result, as shown in FIG. 11 (5), all the gases in the first and third chambers 340a, c are released, and the first and third chambers 340a, c are filled with the reagent.

  Here, the tip cap 80 is removed, and the double-edged needle 100 is attached to the tip tip 70. The inner needle 102 of the double-edged needle 100 passes through the gas-liquid separation membrane 400 and reaches the third chamber 340c. Thereafter, the outer needle 101 of the double-edged needle 100 is inserted into the administration target, and the third piston 330c is further moved to the distal end side via the plunger rod, whereby the drug solution can be administered to the administration target.

  Although the present invention has been described based on the embodiments, the present invention is not limited to the above-described embodiments, and can be applied to various other modes.

  For example, in the first embodiment, one linear slit is formed. However, for example, a plurality of linear slits may be provided. For example, the plurality of slits intersect on the central axis. You may do it.

  In the first embodiment, the gasket and the filter unit are separately formed. However, the gasket and the filter unit may be integrally formed.

  In the first embodiment, the gas-liquid separation membrane 64 is sandwiched between the support members. However, the present invention is not limited to this. For example, the filter unit is not provided, and the gasket 50 is disposed on the drug space S side. The gas-liquid separation membrane 64 may be directly installed, and the tip side surface of the gas-liquid separation membrane 64 may be directly opened to the drug space S. In this case, for example, the gasket is produced by compression molding using a mold. However, when compression molding is performed, improper fixing of the gas-liquid separation membrane or kinking of the membrane occurs. It is necessary to pay attention to this point because there is a possibility that the film may be damaged by handling even after molding. Since the gas-liquid separation membrane has a certain flow path resistance if it is not damaged, a pressure test is performed using a clean gas, and the pressure difference between both sides of the gas-liquid separation membrane is measured. Whether or not the liquid separation membrane is damaged can be confirmed.

  Further, in the first embodiment, the gas / liquid separation unit may be configured by other than the gas / liquid separation membrane. For example, the gasket itself may be made of a material that allows gas to pass but not liquid. In this case, the filter unit is not always necessary.

  Moreover, although 2nd Embodiment demonstrated the example which has arrange | positioned the gas-liquid separation part at the front-end | tip of the syringe which has a double chamber, it is the syringe which has a single chamber (single chamber) like 1st Embodiment. Is also applicable.

  The drug accommodated in the syringe may be, for example, a dissolvable powder (including a salt-like crystal) in addition to the freeze-dried drug. Furthermore, the drug (solute) to be dissolved is not limited to a solid, but may be a liquid.

  In any of the embodiments, the syringe can be used to administer a drug to an administration target using an automatic machine (administrator) with a plunger rod. Therefore, the syringe of any embodiment may be distributed in a configuration that does not include the plunger rod.

10, 300 Syringe 20, 315 Plunger rod 30, 310 Syringe 40, 320a-c Piston 50 Gasket 60 Filter unit 64, 400 Gas-liquid separation membrane

Claims (9)

A cylindrical portion extending in a predetermined direction, a first opening formed at one end of the cylindrical portion in the predetermined direction, and a second opening formed at the other end of the cylindrical portion in the predetermined direction A syringe having a portion;
A syringe that can be accommodated in the cylindrical portion of the syringe from the second opening, and has a piston that can slide in the predetermined direction inside the cylindrical portion,
The piston is
When the piston is accommodated in the cylindrical portion, the gas in the first space is allowed to pass through and the liquid in the first space is passed to a position communicating with the first space on the one end side of the piston. A gas-liquid separator that is not allowed,
A first discharge path capable of discharging the gas that has passed through the gas-liquid separation unit from the one end side to the other end side;
A syringe in which the first discharge path is formed to be openable and closable. A plan having a male thread part to be screwed with the piston and a protrusion formed on the one end side of the male thread part, mounted on the other end side of the piston, and sliding the piston. A jar rod,
The piston has a female screw portion for screwing with the male screw portion of the plunger rod from the other end side, a second space on the other end side of the gas liquid separation portion, and the other end opened. A cylindrical third space, and an opening / closing portion that opens and closes the first discharge path in a communication state between the second space and the third space at a position corresponding to the protrusion. ,
The opening / closing part is
When the protrusion is in the first position in the predetermined direction with respect to the piston, the first discharge path is closed by blocking communication between the second space and the third space,
When the protrusion is inserted to the piston to the second position closer to the one end than the first position, the second space and the third space are brought into contact with the protrusion. Opening the first discharge passage by forming a through-hole communicating therewith,
When the protrusion is inserted to the piston to the third position closer to the one end side than the second position, the protrusion is fitted to the protrusion, whereby the second space and the third The syringe according to claim 1, wherein communication with a space is blocked and the first discharge path is closed. The opening / closing part is
A slit whose length in the predetermined direction does not penetrate to the one end side is formed at a position in contact with the protrusion on the other end side, and is fitted to the protrusion on the one end side. The syringe according to claim 2, wherein a fitting portion having a shape is formed. Syringe according to any one of claims 1 to 3 in which the drug is contained in said one end of the piston of the cylindrical portion. The piston may be any one of claims 1 to 4 having a second discharge path for guiding the gas passing through the gas liquid separating section from the one end to the outer periphery of the piston in the direction intersecting the predetermined direction A syringe as described in 1. A cylindrical portion extending in a predetermined direction, a first opening formed at one end of the cylindrical portion in the predetermined direction, and a second opening formed at the other end of the cylindrical portion in the predetermined direction A syringe having a portion;
A syringe that can be accommodated in the cylindrical portion of the syringe from the second opening, and has a piston that can slide in the predetermined direction inside the cylindrical portion,
The piston is
When the piston is accommodated in the cylindrical portion, the gas in the first space is allowed to pass through and the liquid in the first space is passed to a position communicating with the first space on the one end side of the piston. A gas-liquid separator that is not allowed,
A syringe having a second discharge path that guides the gas that has passed through the gas-liquid separator from the one end side to the outer periphery of the piston in a direction that intersects the predetermined direction. It said piston, when inserted to a predetermined position of the predetermined direction of said syringe, said second discharge path, according to claim 5 or claim 6 is sealed by an inner surface of the tubular portion of the syringe Syringe. A syringe piston capable of being accommodated in a syringe having a cylindrical portion extending in a predetermined direction and having an injection needle attached to one end in the predetermined direction and having an opening formed in the other end. ,
A gas-liquid separator that allows the gas in the first space to pass therethrough and does not allow the liquid in the first space to pass to a position communicating with the first space on the one end side;
A first discharge path capable of discharging the gas that has passed through the gas-liquid separation unit from the one end side to the other end side;
Have
A syringe piston in which the first discharge path is formed to be openable and closable. A syringe piston capable of being accommodated in a syringe having a cylindrical portion extending in a predetermined direction and having an injection needle attached to one end in the predetermined direction and having an opening formed in the other end. ,
A gas-liquid separator that allows the gas in the first space to pass therethrough and does not allow the liquid in the first space to pass to a position communicating with the first space on the one end side;
A syringe piston, comprising: a second discharge path that guides the gas that has passed through the gas-liquid separator from the one end side to the outer periphery of the piston in a direction that intersects the predetermined direction.

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