WO2019004128A1 - Time-of-use dissolving system - Google Patents

Time-of-use dissolving system Download PDF

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Publication number
WO2019004128A1
WO2019004128A1 PCT/JP2018/024012 JP2018024012W WO2019004128A1 WO 2019004128 A1 WO2019004128 A1 WO 2019004128A1 JP 2018024012 W JP2018024012 W JP 2018024012W WO 2019004128 A1 WO2019004128 A1 WO 2019004128A1
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WO
WIPO (PCT)
Prior art keywords
solution
needle
capsule
holder
lever
Prior art date
Application number
PCT/JP2018/024012
Other languages
French (fr)
Japanese (ja)
Inventor
勲 西東
淳也 徳田
山田 秀樹
Original Assignee
伸晃化学株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 伸晃化学株式会社 filed Critical 伸晃化学株式会社
Priority to CN201880043090.9A priority Critical patent/CN110913824B/en
Priority to JP2019526889A priority patent/JP7197173B2/en
Publication of WO2019004128A1 publication Critical patent/WO2019004128A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms

Definitions

  • the present invention relates to an in-use dissolution system for dissolving a predetermined substance with a solution at the time of use.
  • Drugs are often found to be unstable in solution due to hydrolysis. Therefore, it is desirable for drug stability to store drug in a solid state in areas where drug storage conditions are not ready and the temperature is high. Furthermore, it is considered that the stability can be further enhanced by enclosing the drug in a solid state (or in a fluid state without containing water) in a capsule packaged with PTP or the like. Therefore, there is a need to develop a system for dissolving solid state drug stored in a capsule.
  • Patent Document 1 With regard to a system for spouting medicine, a metered dose syringe type spout described in Patent Document 1 is known. However, this drug sprayer relates only to a technology that pre-fills the nasal drops in a dissolved state in a metered dose syringe and allows the nasal drops to be divided and sprayed by pushing the plunger. Thus, Patent Document 1 does not disclose a system for dissolving a solid state drug stored in a capsule.
  • the present invention has been made in view of the above-mentioned fact, and it is possible to dissolve a predetermined substance stored in a capsule at the time of use with a dissolving liquid, and to dissolve the predetermined substance. It is an object of the present invention to provide an in-use dissolution system in combination with a jet for spouting a solution.
  • the in-use dissolution system comprises a capsule holder having a hollow internal space and being formed in a cylindrical shape, and a dissolution liquid having a hollow internal space and having a cylindrical shape.
  • a holder wherein the capsule holder is a first needle portion disposed to divide a first opening formed at one end and an inner space of the capsule holder, The first needle portion has a needle hole portion penetrating the first needle portion, and the needle tip of the first needle portion faces the first opening.
  • the solution holder has a closed end closing an internal space at one end, and the closed end A second opening formed at the end opposite to the second end, and a second needle portion slidable in the inner space of the solution holder, wherein the needle tip of the second needle portion And a second needle portion facing the second opening, wherein an internal space between the bottom surface of the second needle portion and the closed end portion is a solution for containing a solution.
  • the second needle portion includes a solution passage for the solution to exit from the solution chamber, and the capsule holder and the solution holder are needles of the first needle portion
  • the tip end and the needle tip of the second needle portion are slidably fitted to each other in a state of facing each other, and the needle tip of the first needle portion and the needle tip of the second needle portion It is possible to place the said capsule in between.
  • the capsule is disposed in the capsule storage chamber in a state of being in contact with the needle tip of the first needle portion and the needle tip of the second needle portion in the initial state, and the initial state
  • the solution chamber is sealed, and from the initial state, when the solution holder is pushed into the capsule holder, the first and second needle portions closer to each other are
  • the shell of the capsule is pierced to open the capsule, the predetermined substance is released in the capsule storage chamber, and the sealing of the solution chamber is released, whereby the solution is dissolved from the solution chamber.
  • the solution is pushed through the fluid passage into the capsule storage chamber, and the solution dissolves the released predetermined substance to generate a solution.
  • At least one inner wall of the solution holder extends over the inner periphery to slidably hold the second needle portion, as a sealing and unsealing configuration of the solution chamber.
  • An annular ridge is formed.
  • the side wall of the second needle portion is provided with a seal portion extending over the outer periphery, and the seal portion is engaged with the annular ridge from the upper side close to the closed end in the initial state.
  • the solution chamber is sealed by mating.
  • the second needle portion is formed with at least one liquid passage for flowing the solution toward the needle tip from a position closer to the needle tip than the seal portion.
  • the second needle portion punctures the capsule
  • the second needle portion receives resistance, and the closed end is moved relative to the solution holder which is pushed and moved. It moves to the upper side close to the part, whereby the sealing of the solution chamber is released, and the solution flows through the passage for solution flow to the capsule storage chamber.
  • the capsule holder is inserted into the solution holder from the second opening.
  • the capsule holder is provided with a seal portion around the outer periphery in the vicinity of the first opening. More preferably, a step is formed on the inner wall of the solution holder, and when the capsule holder is inserted into the solution holder, the capsule holder and the dissolution are caused by the seal portion engaging with the step.
  • the liquid holder is temporarily locked to be in the initial state, and the seal portion is pushed over the step by pushing the solution holder against the capsule holder with a predetermined force or more from the initial state, and the second state
  • the capsule is opened by the needle tip of the first needle portion and the needle tip of the second needle portion.
  • the capsule holder includes a small diameter portion having a diameter insertable from the second opening of the solution holder, and a large diameter portion having a diameter larger than the second opening. Further pushing of the solution holder into the capsule holder may be locked by engagement of the edge of the solution holder around the second opening with the large diameter portion.
  • a plurality of ridges projecting radially inward from the inner wall and extending along the axial direction are formed to hold the capsule.
  • a finger hook flange is provided on an outer periphery of an end opposite to the end of the capsule holder where the first opening of the capsule holder is formed.
  • an injector may be combined with the in-use dissolution system according to each of the above aspects.
  • the solution in the capsule storage chamber is sucked through the needle hole at the end of the capsule holder opposite to the end where the first opening of the capsule holder is formed.
  • the squirter is engaged.
  • a third opening is formed at the opposite end of the capsule holder, and an internal space of the capsule holder from the third opening to the bottom surface of the first needle portion is Wherein at least a portion of the jets form a jet chamber to be detachably engaged.
  • the spout is a tip that is removably engaged within the spout chamber, the tip having a tip bore that aligns with the needle bore when engaged into the spout chamber.
  • the tip portion A spout extending rearward from the tip, wherein the internal space of the spout is axially slidable in the internal space of the spout and the spout in communication with the tip hole.
  • a piston and a plunger portion axially extending from the piston, wherein the piston is moved away from the tip by pulling the plunger portion away from the spout, thereby causing the piston to move away from the tip.
  • the solution flows into the internal space of the spout through the tip hole, and the piston is moved closer to the tip by pushing the plunger portion closer to the spout, thereby the spout
  • the injector of the preferred embodiment of the present invention is equipped with a double extrusion mechanism.
  • the plunger portion of an injector provided with a double pushing mechanism includes a piston rod extending axially downward from the piston, a lever extending downward from the piston in parallel with the piston rod, and the piston rod A lower end plate disposed below the lever, a boss extending upward from the lower end plate so as to be engageable with the lever, and a spring provided between the lower end plate and the lower end of the piston rod
  • the spring includes a spring that expands as it retracts, and the lever can be bent to be displaced radially from a position aligned with the piston rod, the lever Is formed at the lower end of the lever and engageable with the enlarged spring, and is formed above the lever lower and on the radially outer boss side.
  • the boss in an initial state where the lower end plate is not pushed and the spring is not biased, the boss is accommodated in the first recess, When the lower end plate is pushed, the spring is compressed to engage with the lower portion of the lever, and while the lower end plate is pushed, the boss moves upward with the lower end plate, whereby the boss is moved by the boss When the lower end plate is pushed even after the bosses get over the lever barb and the boss gets over the lever barb, the spring is further contracted, and in this state, the lever and the lever lower portion are engaged by the spring and the lever lower portion.
  • the stopper is positioned radially outward of the initial state against the boss, and the boss engages the flat portion of the lever, and the spring
  • the piston rod and the piston move upward until the stopper moved radially outward engages with the spout, whereby the internal space of the spout
  • the first predetermined amount of the solution filled in the container is spouted from the tip and the lower end plate is not pressed, so that the force by which the spring pushes the lower portion of the lever is reduced.
  • the lever is pushed back inward in the radial direction, and the spring in the further contracted state is extended until the boss enters the second recess and is locked by the lever, and the boss is the lever and the lever.
  • the spring may have an inclined portion which, when retracted, increases the angle with respect to the axial direction to increase the radial length.
  • the boss may include a cylindrical tip and a rod extending from the lower end plate to the tip to support the cylindrical tip.
  • a housing that covers at least a portion of the spout and the piston rod may be provided.
  • the piston rod comprises a first locking projection projecting radially outward from the outer surface of the piston rod, and the housing is a second locking projecting radially inward from the inner wall of the housing.
  • a projection is provided, and the bottom dead center of the piston is defined by the engagement of the first locking projection and the second locking projection.
  • the housing may be provided with a finger flange projecting radially outward.
  • the predetermined substance may be any substance that can be sealed in a capsule and dissolved in a solution to form a solution that can achieve a certain purpose.
  • the predetermined substance is a solid powder drug.
  • FIG. 1 is a longitudinal cross-sectional view (with parts removed) of an on-the-fly dissolution system combined with a sprayer, according to one embodiment of the present invention.
  • FIG. 2 is a longitudinal sectional view (excluding a part) of the in-use dissolution system in a state where the solution is generated by the in-use dissolution system of FIG. 1 and the solution is transferred to the sprayer.
  • FIG. 3 is a view of a capsule holder which is one of the configuration requirements of the in-use dissolution system according to the present embodiment, wherein (a) is a plan view and (b) is a front view as a partial sectional view; c) is a perspective view of the first needle portion.
  • FIG. 1 is a longitudinal cross-sectional view (with parts removed) of an on-the-fly dissolution system combined with a sprayer, according to one embodiment of the present invention.
  • FIG. 2 is a longitudinal sectional view (excluding a part) of the in-use dissolution system in a state
  • FIG. 4 is a front view partially showing a housing of a solution holder, which is one of the configuration requirements of the in-use dissolution system according to the present embodiment, as a cross-sectional view.
  • FIG. 5 is a view of a second needle portion attached to the housing of the solution holder of FIG. 4, where (a) is a front view shown as a partial cross-sectional view, (b) is a bottom view, c) is a perspective view.
  • 6 is a front view shown as a partial cross-sectional view of a solution holder completed by attaching the second needle portion of FIG. 5 to the housing of FIG. 4;
  • FIG. 7 is a cross-sectional view showing an outflow route of the solution filled in the solution holder of FIG. FIG.
  • FIG. 8 is a view showing preparation of the in-use dissolution system according to the embodiment loaded with the capsule by connecting the capsule holder containing the capsule and the solution holder.
  • FIG. 9 is a cross-sectional view of the locking mechanism of the in-use dissolution system loaded with the capsule of FIG. 8;
  • FIG. 10 is a longitudinal sectional view of the squirter, showing a state in which the combination of the capsule holder and the solution holder is removed from the squirter in the in-use dissolution system according to the present embodiment.
  • 11 is a view showing a plunger portion of the jet device of FIG. 10, wherein (a) is a plan view, (b) is an upper end view, a left side view, a lower end view, and (c) shows a bottom view.
  • FIG. 12 is a view showing a part of the plunger portion of FIG. 11, wherein (a) is a cross-sectional view taken along the line AA of FIG. 11 (b), and (b) is a B of FIG.
  • FIG. 11C is a cross-sectional view taken along the line B
  • FIG. 11C is an enlarged detail of a portion indicated by C in FIG. 11B
  • FIG. 13 is a diagram showing the operation of the ejector of FIG. 11 when the ejector of FIG.
  • FIG. 14 is a view showing another use example of the sprayer of FIG.
  • FIG. 15 is a view for explaining the preparation step of the vial in another use example of the ejector of FIG. 14;
  • Fig. 16 is a view of a second needle portion of another example attached to the housing of the solution holder of Fig. 4, wherein (a) is a front view shown as a partial sectional view, (b) Is a perspective view.
  • FIG. 1 shows an in-use dissolution system 1 according to an embodiment of the present invention, which enables a predetermined substance stored in a capsule at the time of use to be dissolved in a solution.
  • the in-use dissolution system 1 is combined with the ejector 2 for ejecting the solution generated by the in-use dissolution system 1, and the in-use dissolution system 5 (that is, the in-use dissolution injection system) is configured. .
  • the in-use dissolution system 1 includes a capsule holder 3 formed in a cylindrical shape with a hollow internal space, and a dissolution liquid holder 4 formed in a cylindrical shape with a hollow internal space. .
  • the capsule holder 3 accommodates a capsule 6 in which a predetermined substance such as a drug powder is wrapped in PTP or the like, and the solution holder 4 contains a solution 7 capable of dissolving the drug powder in the capsule 6.
  • FIG. 2 shows a state in which the capsule 6 is opened by the dissolution system 1 at the time of use and the substance wrapped in the capsule is dissolved in the dissolution liquid to generate a solution, which will be described later in detail.
  • the capsule holder 3 separates the opening 10 (first opening) formed at one end from the internal space of the capsule holder 3. And a first needle portion 11 disposed.
  • a seal portion 19 is provided around the outer periphery of the capsule holder in the vicinity of the opening 10. The seal portion 19 is provided for sealing at the time of fitting with the solution holder 4 described later.
  • the first needle portion 11 has a needle hole portion 17 penetrating the first needle portion, and the needle tip 12 of the first needle portion 11 faces the opening 10.
  • An example of the 1st needle part 11 is shown in Drawing 3 (c).
  • the first needle portion 11 has a shape in which the side of its needle tip 12 is partially cut from the shape of a cone, and the cut portion of the needle tip 12 A through hole 18 is formed as a hole on the needle side of the needle hole portion 17 in the.
  • three through holes 18 are formed every 120 degrees.
  • the first needle portion 11 may be formed integrally with the capsule holder 3.
  • An internal space of the capsule holder 3 between the needle tip 12 of the first needle portion 11 and the opening 10 forms a capsule accommodating chamber 13 capable of accommodating the capsule 6.
  • the inner wall of the capsule holder 3 defining the capsule chamber 13 is formed with a ridge 20 which protrudes radially inward from the inner wall and extends along the axial direction. It is done.
  • the ridges 20 may be provided at three positions every 120 degrees, as shown in FIG. 3 (a).
  • An opening 16 (third opening) is formed at the end of the capsule holder 3 opposite to the opening 10, and a flange 16a is formed on the capsule holder outer wall near the opening 16. Further, the capsule holder 3 is divided into a small diameter portion 3a which is a cylindrical portion with a small diameter and a large diameter portion 3b which is a cylindrical portion with a large diameter.
  • the internal space between the first needle portion 11 and the opening 16 forms a jet chamber (14, 15) into which the tip of the jet 2 is inserted.
  • a ridge 21 for holding the front end of the jet 2 is formed in the jet chamber 15 on the large diameter portion 3 b side.
  • the solution holder 4 has a closed end 22 closing the inner space at one end and an opening 23 formed at the opposite end of the closed end 22 An opening 2) and a second needle portion 25 slidable in the internal space of the solution holder 4 are provided.
  • the needle tip 27 of the second needle 25 faces the opening 23.
  • the inner wall of the solution holder 4 is provided with a side wall of the second needle portion 25.
  • An annular ridge 24 is formed extending around the inner periphery so as to be in contact therewith. In the present embodiment, two annular ridges 24 are formed in order to ensure stable holding of the second needle portion 25, but the present invention is not limited to this.
  • the second needle portion 25 has a base 26, a needle tip 27 extending from the base 26, and a seal extending over the outer periphery of the base 26, as shown in FIGS. 5 (a) and 5 (c). And a unit 29. Further, as shown in FIGS. 5B and 5C, on the side wall of the base 26, there is formed a liquid flow passage groove 28 extending in the axial direction below the seal portion 29. As shown in FIG. A plurality of liquid flow grooves 28 may be formed.
  • the opening 23 is sized so as to allow insertion of the small diameter portion 3 a of the capsule holder 3, and the sealing portion 19 of the capsule holder 3 maintains the sealing performance by coming into contact with the inner wall of the solution holder 4. However, it is possible to slide the capsule holder 3 and the solution holder 4 with respect to each other.
  • the internal space between the bottom of the second needle 25 and the closed end 22 forms a solution chamber 30 for containing a solution.
  • air 31 may enter the solution chamber 30.
  • the seal portion 29 (FIGS. 5A and 5C) is not in contact with the inner wall of the solution holder 4, and the upper annular ridge 24 (FIG. 4) near the closed end 22 By engaging, the solution chamber 30 is sealed.
  • the second needle portion 25 is positioned between the side wall of the second needle portion 25 and the inner wall of the solution chamber 30, A solution passage is formed to allow the solution to exit from the solution chamber 30 along the C direction toward the tip end of the second needle portion. That is, the solution passes from the solution chamber 30 through the small gap formed between the upper side wall of the second needle portion and the inner wall of the solution chamber 30, and passes the seal portion 29, and the second needle portion It is possible to flow toward the tip of the needle through the fluid communication groove 28 which is not completely closed by the ridge 24 in contact with it. Of course, it is also possible to form a through hole (not shown) which penetrates the second needle portion 25 itself as a solution passage.
  • the capsule 6 When assembling the in-use dissolution system 1 from the capsule holder 3 and the solution holder 4 described above, the capsule 6 is put in the capsule storage chamber of the capsule holder 3 as shown in FIG. The end on the 10 side is inserted from the opening 23 of the solution holder 4 in which the solution 7 is placed in the solution chamber 30. At this time, the capsule 6 is disposed between the needle tip 27 of the facing second needle portion 25 and the needle tip 12 of the first needle portion 11.
  • the assembled in-use dissolution system of FIG. 8 corresponds to the in-use dissolution system of FIG. 1, and the capsule 6 is formed of the needle tip 27 of the second needle portion 25 and the needle tip 12 of the first needle portion 11. It is placed in contact.
  • the seal portion 19 described above is formed on the outer wall near the opening 10 of the capsule holder 3 and on the inner wall of the solution holder.
  • a step 33 is formed.
  • the seal portion 19 engages with the step 33 to temporarily lock the capsule holder 3 and the solution holder 4.
  • a position (initial state) where the needle tip 12 of the first needle portion 11 and the needle tip 27 of the second needle portion 25 contact the capsule 6 Become.
  • the seal portion 19 gets over the step 33 and the capsule holder 3 and the solution holder 4 come closer.
  • the solution holder 4 is pushed in the direction of arrow A with a predetermined force or more.
  • This operation can be realized, for example, by putting the forefinger and the middle finger on the flange 16a and pushing the closed end of the solution holder 4 with the thumb.
  • FIG. 2 the state in which the solution in the capsule storage chamber 13 is sucked into the spout 36 of the ejector 2 is shown by pulling the piston 38 of the ejector 2 in the B direction.
  • the ejector which concerns on this embodiment is demonstrated below.
  • FIG. 10 shows the jet 2 removed from the in-use dissolution system 1.
  • the jet 2 is a tip 35 which is detachably engaged in the jet chamber (14 of FIG. 3 (b)) when the jet 2 is attached to the in-use melting system 1.
  • a spout 36 extending rearward from the tip 35, a piston 38 axially slidable in the internal space of the spout 36, and a housing 37 covering the tip 35, the spout 36 and the piston 38.
  • a plunger portion 32 (FIG. 11) extending axially from the piston.
  • the plunger portion 32 includes a plunger operating portion 50 for operating the plunger portion.
  • the tip portion 35 has a tip hole 34 that aligns with the needle hole 17 (FIG. 3 (b)) when engaged within the jet chamber 14.
  • the tip hole 34 communicates with the internal space of the spout 36 via the conduit 61.
  • the upper portion of the housing 37 is also detachably engaged in the ejector chamber (15 of FIG. 3 (b)).
  • the housing 37 is provided with a finger flange 42 that protrudes radially outward.
  • the piston 38 is moved closer to the tip 35 by pushing the plunger 32 closer to the spout 36, whereby the inside of the spout 36 Solution jets out through the conduit 61 and the tip hole 34.
  • tip part 35 can also be comprised as a nozzle part for spraying a solution.
  • the squirter 2 according to the present embodiment is provided with a double-pushing mechanism capable of jetting the suctioned solution twice for each of the first predetermined amount and the second predetermined amount without switching operation.
  • FIG.10, 11 and 12 the structure regarding the plunger part 32 of the ejector 2 provided with a twice pushing mechanism is demonstrated in detail using FIG.10, 11 and 12.
  • FIG.10, 11 and 12 the structure regarding the plunger part 32 of the ejector 2 provided with a twice pushing mechanism is demonstrated in detail using FIG.10, 11 and 12.
  • the plunger portion 32 includes a piston rod 39 extending axially downward from the piston 38, a lever 45 extending downward from the piston 38 in line with the piston rod 39, and a piston rod 39. And a lower end plate 51 disposed below the lever 45, a spout ring 43, and a main portion of a double pushing mechanism disposed in the spout ring 43.
  • the piston rod 39 further includes a first locking projection 41 projecting radially outward from the outer surface of the piston rod 39, and the housing 37 is a second projecting radially inward from the inner wall of the housing 37.
  • a locking projection 40 is provided, and the lower dead center of the piston 38 is defined by the engagement of the first locking projection 41 and the second locking projection 40, and the piston 38 can be prevented from coming off.
  • a seal 48 (FIGS. 11 (c) and 12 (d)) for sliding the spout inside in a sealed state is formed.
  • the plunger operating portion 50 disposed in the spout ring 43 engages with the lever 45 upward from the lower end plate 51.
  • a boss 54 which can extend is provided, and a spring 52 which is provided between the lower end plate 51 and the lower end of the piston rod 39 and which expands in diameter when it is contracted.
  • the lever 45 which is one of the requirements of the double pushing mechanism can be bent so as to be displaced in the radial direction from the position aligned with the piston rod 39, and the lever 45 is provided at the lower end of the lever.
  • a lower lever portion 55 is provided and engageable with the inclined portion 52a of the expanded spring, and a lever return 56 which is formed above the lower lever portion 55 and protrudes toward the radially outer boss 54, and the lower lever 55
  • the first recess 57 formed between the first and second levers 56, the second recess 58 formed adjacent to the upper side of the lever 56, and the flat portion formed above the second recess 58
  • a stopper 47 projecting radially outward at a predetermined position of the lever 45 above the flat portion 59.
  • the spring 52 has an inclined portion 52a (FIG. 12 (c)) of the spring which, when compressed, increases the angle with respect to the axial direction to increase the radial length
  • the boss 54 has a cylindrical tip (54). And a rod 53 extending from the lower end plate 51 to the tip to support the cylindrical tip.
  • the sprayer 2 can push out the solution in the spout 36, for example, by putting the index finger and the middle finger on the flange 42 (FIG. 10) and pushing the lower end plate 51 with the thumb.
  • the boss 54 is accommodated in the first recess 57.
  • the stopper 47 is located radially inward of the radial position that can be engaged with the lower end edge of the spout.
  • step (1) when the lower end plate 51 is pressed (step (1)), the spring 52 is contracted and radially expanded outward, so the inclined portion 52a of the spring engages with the lever lower portion 55 (step (1)) ). While the lower end plate 51 is pressed, the boss 54 moves upward with the lower end plate 51, whereby the boss 54 tries to get over the lever bar 56 while the rod 53 is bent radially outward.
  • step (2) When the lower end plate 51 is pushed even after the boss 54 gets over the lever return 56 (step (2)), the spring 52 is in a further contracted state (for example, the fully contracted state). In this state, the inclined portion 52a of the spring and the lever Due to the engagement with the lower portion 55, the lever 45 and the stopper 47 are positioned radially outward of the initial state against the force of the boss 54 trying to return radially inward, and the boss 54 is a flat portion 59 of the lever 45. Engage in At this time, the stopper 47 has moved to a radial position where it can be engaged with the lower end edge of the spout 36.
  • step (3) When the lower end plate 51 is pushed (step (3)) in the state where the spring 52 is further contracted (for example, the fully contracted state), the pushed force can no longer be absorbed by the spring 52. Is used to move upwards. That is, the piston rod 39 and the piston 38 move upward until the stopper 47 moved radially outward engages with the spout 36, whereby the first portion of the solution filled in the internal space of the spout 36 A metered amount of solution is expelled from tip hole 34 through conduit 61.
  • the finger is once released from the lower end plate 51 (step (4)).
  • the force by which the inclined portion 52a of the spring pushes the lever lower portion 55 is reduced, so that the boss 54 pushes back the lever 45 more inward in the radial direction.
  • the boss 54 extends into the second recess 58 until it is locked by the lever bar 56. At this time, since the boss 54 moves the lever 45 and the stopper 47 more inward in the radial direction, the stopper 47 is released.
  • step (5) After the stopper 47 is released, when the lower end plate 51 is pushed again (step (5)), the piston rod 39 and the piston 38 move upward, and the second predetermined amount of solution remaining in the spout 36 It spouts from the tip hole 34.
  • the powder and the solution are mixed at the time of use in a vaccine etc., and the solution is moved to the spout side of the ejector 2
  • Each can be administered by spraying into the nasal cavity.
  • the first predetermined amount and the second predetermined amount may be equal to each other, but may be arbitrarily changed to different ratios.
  • the ejector 2 since the ejector 2 according to the present embodiment spreads the lever 45 by the inclined portion 52a of the spring, the locking function of the stopper 47 can be reliably operated as compared with the double pushing mechanism of the prior art. . Further, by pulling the lever 45 inward by the boss 54, the stopper 45 can be reliably released.
  • FIG. 14 shows an example of use of the sprayer 2 for sucking and dispensing a drug solution in a vial. Further, FIG. 15 shows a process of preparing a drug solution in a vial.
  • the vial 80 contains a powdered drug 77 and is sealed with a cap 82 so that moisture is not stored therein.
  • the needle 91 of the syringe 90 containing the solution is pierced through the cap 82 to inject the solution into the vial 80.
  • the injected solution dissolves the powdered drug 77 to produce a drug solution (solution) 81.
  • the connection adapter 70 between the vial 80 and the ejector is loaded into the vial 80.
  • the connection adapter 70 includes a vial side holding portion 71 a and a jetting device side holding portion 71 b.
  • the vial side holding portion 71a is formed with a recess for inserting the vial 80 containing the drug solution 81 and sealed with the puncturable cap 82 from the cap side, and the oblique head from the central portion of the recess
  • a truncated needle 72 extends.
  • a through hole 73 penetrating the connection adapter 70 is formed in the needle portion 72.
  • tip part 35 of the ejector 2 demonstrated above is formed in the ejector side holding part 71b.
  • the cap 82 is opened by the needle portion 72.
  • the through hole 73 of the needle portion 72 of the connection adapter 70 and the tip hole 34 of the ejector 2 are aligned.
  • the drug solution 81 can reach the tip hole 34 of the sprayer 2 through the through hole 73 of the needle portion 72.
  • the piston 38 is moved downward in the spout 36 (see FIGS. 2 and 13) by pulling the piston rod 39 downward, and the drug solution 81 in the vial 80 has a needle portion 72.
  • the spout 36 is sucked through the through hole 73 and the tip hole 34 of the sprayer 2. If the squirter 2 is taken out of the connection adapter 70 after the liquid chemical suction, as described above, the liquid drug 81 can be ejected twice in two steps.
  • the ejector 2 which concerns on this embodiment can be considered besides the example of FIG.
  • it may be connected to a glass bottle containing a drug solution having viscosity, and the content liquid may be sucked and taken out, and may be ejected twice in two steps.
  • it can be used for reagent applications such as sucking a sample and dispensing it to reaction solutions A and B.
  • a groove 28 for liquid flow is formed on the side wall of the second needle portion 25 of the solution holder for taking out the solution from the solution chamber (FIGS. 5A to 5C) ).
  • the present invention is not limited to only this example, and a passage for liquid flow is formed to flow the solution toward the needle tip 27 from a position closer to the needle tip 27 than the seal portion 29 of the second needle portion 25. It should be done.
  • a fluid flow passage passes through the inside of the second needle portion instead of the groove of the side wall like the fluid flow groove 28.
  • the through hole 28a for liquid flow radially penetrates the side wall of the base 26 from the position below the seal portion 29, and becomes an axial through hole inside the base and approaches the needle apex of the needle tip 27 It penetrates to the position.

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Abstract

Provided is a time-of-use dissolving system for dissolving a predetermined substance in a capsule using a dissolving liquid at the time of use. The time-of-use dissolving system 1 is provided with a capsule holder 3 and a dissolving liquid holder 4. The capsule holder 3 is provided with a first opening portion and a first needle portion, and forms a capsule storage compartment in which a capsule 6 can be stored. The dissolving liquid holder 4 is provided with a closed end portion, a second opening portion, and a second needle portion which is slidable in an internal space and includes a dissolving liquid passageway, the dissolving liquid holder 4 forming a dissolving liquid compartment. The capsule holder 3 and the dissolving liquid holder 4 are slidably mated with each other in a state in which needle tips of the first and the second needle portions are opposed to each other, with the capsule 6 disposed between the needle tips. A sprayer 2 provided with a twice-extrusion mechanism is mated with the capsule holder 3. The mechanism is provided with a lever parallel with a piston rod, a spring between a lower-end plate and the piston rod, and a boss, wherein the lever is provided with a stopper that is locked on a spout by the first extrusion, a lever lower portion engageable with the boss, a lever return, and a recess portion.

Description

用時溶解システムIn-use dissolution system
 本発明は、用時に所定の物質を溶解液で溶解するための用時溶解システムに関する。 The present invention relates to an in-use dissolution system for dissolving a predetermined substance with a solution at the time of use.
 薬剤は、溶液状態では加水分解のため不安定になる場合が多く認められている。そのため薬剤の保管状況が整っておらず気温の高い地域では、薬剤を固体状態で保管することが薬剤の安定性にとって望ましいことである。さらに、固体状態(或いは水分の入っていない流動状態)の薬剤を、PTP等で包装したカプセル内に閉じ込めれば安定性をより高めることができると考えられる。従って、カプセルに保管された固体状態の薬剤を溶解するためのシステムを開発することが求められている。 Drugs are often found to be unstable in solution due to hydrolysis. Therefore, it is desirable for drug stability to store drug in a solid state in areas where drug storage conditions are not ready and the temperature is high. Furthermore, it is considered that the stability can be further enhanced by enclosing the drug in a solid state (or in a fluid state without containing water) in a capsule packaged with PTP or the like. Therefore, there is a need to develop a system for dissolving solid state drug stored in a capsule.
 薬剤を噴出するシステムに関しては、特許文献1に記載された定量シリンジ型噴出器が知られている。しかし、この薬剤噴出器は、定量シリンジ内に予め溶解状態の点鼻薬を充填しておき、プランジャの押し込みにより、点鼻薬を小分けして噴霧することを可能とする技術にのみ関している。従って、特許文献1にはカプセルに保管された固体状態の薬剤を溶解するためのシステムは開示されていない。 With regard to a system for spouting medicine, a metered dose syringe type spout described in Patent Document 1 is known. However, this drug sprayer relates only to a technology that pre-fills the nasal drops in a dissolved state in a metered dose syringe and allows the nasal drops to be divided and sprayed by pushing the plunger. Thus, Patent Document 1 does not disclose a system for dissolving a solid state drug stored in a capsule.
特開2013-230208号公報JP 2013-230208 A
 本願発明は、上記事実に鑑みなされたものであり、用時にカプセル内に保管した所定の物質を溶解液で溶解することを可能とする用時溶解システム、並びに、所定の物質が溶解されてできた溶液を噴出するための噴出器と組み合わされた用時溶解システムを提供することをその目的とするものである。 The present invention has been made in view of the above-mentioned fact, and it is possible to dissolve a predetermined substance stored in a capsule at the time of use with a dissolving liquid, and to dissolve the predetermined substance. It is an object of the present invention to provide an in-use dissolution system in combination with a jet for spouting a solution.
 上記課題を解決するため、本発明の用時溶解システムは、中空の内部空間を有して筒状に形成されたカプセルホルダーと、中空の内部空間を有して筒状に形成された溶解液ホルダーと、を備え、前記カプセルホルダーは、一方の端部に形成された第1の開口部と、前記カプセルホルダーの内部空間を仕切るように配置された第1の針部であって、該第1の針部は、該第1の針部を貫通する針孔部を有し、該第1の針部の針先端は、前記第1の開口部に向いている、前記第1の針部と、を備え、前記第1の針部の針先端と前記第1の開口部との間の前記カプセルホルダーの内部空間は、所定の物質を包むカプセルを収容可能なカプセル収容室を形成し、前記溶解液ホルダーは、一方の端部において内部空間を閉塞する閉塞端部と、前記閉塞端部の反対側の端部に形成された第2の開口部と、前記溶解液ホルダーの内部空間で摺動可能な第2の針部であって、該第2の針部の針先端は、前記第2の開口部に向いている、前記第2の針部と、を備え、該第2の針部の底面と前記閉塞端部との間の内部空間は、溶解液を入れるための溶解液室を形成し、前記第2の針部は、前記溶解液が前記溶解液室から出るための溶解液通路を備え、前記カプセルホルダーと前記溶解液ホルダーとは、前記第1の針部の針先端及び前記第2の針部の針先端とが対向した状態で互いに対して摺動可能に嵌合されており、前記第1の針部の針先端及び前記第2の針部の針先端との間に前記カプセルを配置することが可能である。 In order to solve the above problems, the in-use dissolution system according to the present invention comprises a capsule holder having a hollow internal space and being formed in a cylindrical shape, and a dissolution liquid having a hollow internal space and having a cylindrical shape. A holder, wherein the capsule holder is a first needle portion disposed to divide a first opening formed at one end and an inner space of the capsule holder, The first needle portion has a needle hole portion penetrating the first needle portion, and the needle tip of the first needle portion faces the first opening. And the internal space of the capsule holder between the needle tip of the first needle portion and the first opening forms a capsule accommodating chamber capable of accommodating a capsule that encloses a predetermined substance, The solution holder has a closed end closing an internal space at one end, and the closed end A second opening formed at the end opposite to the second end, and a second needle portion slidable in the inner space of the solution holder, wherein the needle tip of the second needle portion And a second needle portion facing the second opening, wherein an internal space between the bottom surface of the second needle portion and the closed end portion is a solution for containing a solution. Forming a chamber, the second needle portion includes a solution passage for the solution to exit from the solution chamber, and the capsule holder and the solution holder are needles of the first needle portion The tip end and the needle tip of the second needle portion are slidably fitted to each other in a state of facing each other, and the needle tip of the first needle portion and the needle tip of the second needle portion It is possible to place the said capsule in between.
 本発明によれば、前記カプセルは、初期状態で、前記第1の針部の針先端及び前記第2の針部の針先端により接触された状態で前記カプセル収容室に配置され、前記初期状態で、前記溶解液室は密封されており、前記初期状態から、前記溶解液ホルダーを前記カプセルホルダーに対して押し込んだとき、互いにより接近した前記第1の針部及び前記第2の針部が前記カプセルの外皮を突き破って該カプセルを開封し、前記所定の物質を前記カプセル収容室内で解放し、さらに前記溶解液室の密封が解除され、これによって前記溶解液が前記溶解液室から前記溶解液通路を通って前記カプセル収容室へと押し出され、該溶解液により、解放された前記所定の物質が溶解されて溶液が生成される。 According to the present invention, the capsule is disposed in the capsule storage chamber in a state of being in contact with the needle tip of the first needle portion and the needle tip of the second needle portion in the initial state, and the initial state The solution chamber is sealed, and from the initial state, when the solution holder is pushed into the capsule holder, the first and second needle portions closer to each other are The shell of the capsule is pierced to open the capsule, the predetermined substance is released in the capsule storage chamber, and the sealing of the solution chamber is released, whereby the solution is dissolved from the solution chamber. The solution is pushed through the fluid passage into the capsule storage chamber, and the solution dissolves the released predetermined substance to generate a solution.
 溶解液室の密封及び密封解除の構成として、好ましくは、前記溶解液ホルダーの内壁には、前記第2の針部を摺動可能に保持するため内周囲に亘って延在する、少なくとも1つの環状リッジが形成されている。また、前記第2の針部の側壁には、外周囲に亘って延在するシール部が設けられ、該シール部は、前記初期状態において、前記閉塞端部に近い上側から前記環状リッジと係合することにより前記溶解液室を密封している。さらに、前記第2の針部には、前記シール部よりも前記針先端に近い位置から該針先端に向かって溶解液を流すための少なくとも1つの液流通用通路が形成されている。上記のような構成において、前記第2の針部が前記カプセルを穿刺する際に該第2の針部が抵抗を受け、押し込まれて移動する前記溶解液ホルダーに対して相対的に前記閉塞端部に近い上側に移動し、これによって前記溶解液室の密封が解除され、溶解液が前記液流通用通路を通って前記カプセル収容室へと流れる。 Preferably, at least one inner wall of the solution holder extends over the inner periphery to slidably hold the second needle portion, as a sealing and unsealing configuration of the solution chamber. An annular ridge is formed. Further, the side wall of the second needle portion is provided with a seal portion extending over the outer periphery, and the seal portion is engaged with the annular ridge from the upper side close to the closed end in the initial state. The solution chamber is sealed by mating. Furthermore, the second needle portion is formed with at least one liquid passage for flowing the solution toward the needle tip from a position closer to the needle tip than the seal portion. In the configuration as described above, when the second needle portion punctures the capsule, the second needle portion receives resistance, and the closed end is moved relative to the solution holder which is pushed and moved. It moves to the upper side close to the part, whereby the sealing of the solution chamber is released, and the solution flows through the passage for solution flow to the capsule storage chamber.
 カプセルホルダーと溶解液ホルダーとの嵌合態様として、例えば、前記カプセルホルダーは、前記第2の開口部から前記溶解液ホルダー内へと挿入されている。このとき、好ましくは前記カプセルホルダーには、前記第1の開口部の付近の外周囲に亘ってシール部が設けられている。さらに好ましくは、前記溶解液ホルダーの内壁に段差が形成されており、前記カプセルホルダーを前記溶解液ホルダー内に挿入するとき、前記シール部が前記段差と係合することにより前記カプセルホルダー及び前記溶解液ホルダーが一旦係止されて前記初期状態となり、該初期状態から所定以上の力で前記溶解液ホルダーを前記カプセルホルダーに対して押し込むことによって前記シール部が前記段差を乗り越え、より接近した前記第1の針部の針先端及び前記第2の針部の針先端によって前記カプセルが開封される。また、前記カプセルホルダーは、前記溶解液ホルダーの前記第2の開口部から挿入可能な径を有する小径部と、前記第2の開口部よりも大きい径を有する大径部と、を備え、前記第2の開口部の周囲の前記溶解液ホルダーの縁部が前記大径部と係合することによって、前記溶解液ホルダーの前記カプセルホルダーへのさらなる押し込みが係止されてもよい。 As a fitting aspect of a capsule holder and a solution holder, for example, the capsule holder is inserted into the solution holder from the second opening. At this time, preferably, the capsule holder is provided with a seal portion around the outer periphery in the vicinity of the first opening. More preferably, a step is formed on the inner wall of the solution holder, and when the capsule holder is inserted into the solution holder, the capsule holder and the dissolution are caused by the seal portion engaging with the step. The liquid holder is temporarily locked to be in the initial state, and the seal portion is pushed over the step by pushing the solution holder against the capsule holder with a predetermined force or more from the initial state, and the second state The capsule is opened by the needle tip of the first needle portion and the needle tip of the second needle portion. In addition, the capsule holder includes a small diameter portion having a diameter insertable from the second opening of the solution holder, and a large diameter portion having a diameter larger than the second opening. Further pushing of the solution holder into the capsule holder may be locked by engagement of the edge of the solution holder around the second opening with the large diameter portion.
 好ましくは、前記カプセル収容室を画定する前記カプセルホルダーの内壁には、前記カプセルを保持するため、該内壁から径方向内側に突出すると共に軸方向に沿って延びる複数のリッジが形成されている。また、前記カプセルホルダーの前記第1の開口部が形成された前記カプセルホルダーの端部とは反対側の端部の外周囲には、指掛用フランジが設けられている。 Preferably, on the inner wall of the capsule holder defining the capsule accommodating chamber, a plurality of ridges projecting radially inward from the inner wall and extending along the axial direction are formed to hold the capsule. In addition, a finger hook flange is provided on an outer periphery of an end opposite to the end of the capsule holder where the first opening of the capsule holder is formed.
 本発明の用時溶解システムは、上記各態様に係る用時溶解システムに噴射器が組み合わされてもよい。当該用時溶解システムでは、前記カプセルホルダーの前記第1の開口部が形成された前記カプセルホルダーの端部とは反対側の端部には、前記カプセル収容室内の溶液を前記針孔部を通して吸引する噴出器が係合されている。また、前記カプセルホルダーの前記反対側の端部には、第3の開口部が形成されており、前記第3の開口部から前記第1の針部の底面までの前記カプセルホルダーの内部空間は、前記噴出器の少なくとも一部が脱着可能に係合される噴出器室を形成している。 In the in-use dissolution system according to the present invention, an injector may be combined with the in-use dissolution system according to each of the above aspects. In the dissolution system for use, the solution in the capsule storage chamber is sucked through the needle hole at the end of the capsule holder opposite to the end where the first opening of the capsule holder is formed. The squirter is engaged. Further, a third opening is formed at the opposite end of the capsule holder, and an internal space of the capsule holder from the third opening to the bottom surface of the first needle portion is Wherein at least a portion of the jets form a jet chamber to be detachably engaged.
 前記噴出器は、前記噴出器室内に脱着可能に係合される先端部であって、該先端部は、前記噴出器室内に係合されたとき前記針孔部と整合する先端孔を有する、前記先端部と、
 前記先端部から後方に延在するスパウトであって、該スパウトの内部空間は、前記先端孔と連通している、前記スパウトと、前記スパウトの内部空間内を軸方向に摺動可能に構成されたピストンと、前記ピストンから軸方向に延在するプランジャ部と、を備え、前記プランジャ部を、前記スパウトから離れるように引くことによって前記ピストンが前記先端部から離れるように移動し、これによって前記先端孔を通って前記溶解液が前記スパウトの内部空間に流入し、前記プランジャ部を、前記スパウトに近づけるように押すことによって前記ピストンが前記先端部に接近するように移動し、これによって前記スパウト内の溶液が前記先端孔を通って噴出する。
The spout is a tip that is removably engaged within the spout chamber, the tip having a tip bore that aligns with the needle bore when engaged into the spout chamber. The tip portion;
A spout extending rearward from the tip, wherein the internal space of the spout is axially slidable in the internal space of the spout and the spout in communication with the tip hole. A piston and a plunger portion axially extending from the piston, wherein the piston is moved away from the tip by pulling the plunger portion away from the spout, thereby causing the piston to move away from the tip. The solution flows into the internal space of the spout through the tip hole, and the piston is moved closer to the tip by pushing the plunger portion closer to the spout, thereby the spout The solution inside squirts through the tip hole.
 本発明の好ましい態様の噴射器は、2回押し出し機構を備えている。2回押し出し機構を備えた噴射器の前記プランジャ部は、前記ピストンから軸方向に下方に延在するピストンロッドと、前記ピストンロッドと並んで前記ピストンから下方に延在するレバーと、前記ピストンロッド及び前記レバーの下方に配置された下端プレートと、前記下端プレートから上方に前記レバーと係合可能に延在するボスと、前記下端プレートと前記ピストンロッドの下端との間に設けられたバネであって、該バネは、縮むときに拡径する、前記バネと、を備え、前記レバーは、前記ピストンロッドと並んだ位置から径方向に変位するように撓むことが可能であり、前記レバーは、前記レバーの下端に設けられ、拡径した前記バネと係合可能なレバー下部と、前記レバー下部よりも上方に形成され、径方向外側の前記ボスの側に突出するレバー返しと、前記レバー下部と前記レバー返しとの間に形成された第1の凹部と、前記レバー返しの上方に隣接して形成された第2の凹部と、前記第2の凹部の上方に形成された平坦部と、前記平坦部よりも上方の前記レバーの所定の位置で径方向外側に突出するストッパーと、を備える。 The injector of the preferred embodiment of the present invention is equipped with a double extrusion mechanism. The plunger portion of an injector provided with a double pushing mechanism includes a piston rod extending axially downward from the piston, a lever extending downward from the piston in parallel with the piston rod, and the piston rod A lower end plate disposed below the lever, a boss extending upward from the lower end plate so as to be engageable with the lever, and a spring provided between the lower end plate and the lower end of the piston rod And the spring includes a spring that expands as it retracts, and the lever can be bent to be displaced radially from a position aligned with the piston rod, the lever Is formed at the lower end of the lever and engageable with the enlarged spring, and is formed above the lever lower and on the radially outer boss side. A first recess formed between the lower lever and the lower lever, a second recess formed adjacently above the lower lever, and a second recess formed between the lower lever and the lower lever; A flat portion formed on the upper side, and a stopper projecting radially outward at a predetermined position of the lever above the flat portion.
 本発明の2回押し出し機構を備えた噴射器によれば、前記下端プレートが押されずに前記バネが付勢されていない初期状態では、前記ボスは前記第1の凹部内に収まっており、前記下端プレートが押されたとき、前記バネが縮んで前記レバー下部と係合し、前記下端プレートが押されている間に、前記ボスは前記下端プレートと共に上方に移動し、これによって前記ボスが前記レバー返しを乗り越え、前記ボスが前記レバー返しを乗り越えた後も前記下端プレートが押されるとき、前記バネはさらに縮んだ状態となり、この状態において前記バネと前記レバー下部との係合により前記レバー及び前記ストッパーは前記ボスに対抗して前記初期状態よりも径方向外側に位置すると共に前記ボスが前記レバーの前記平坦部に係合し、前記バネが前記さらに縮んだ状態で前記下端プレートが押されるとき、前記ピストンロッド及び前記ピストンが、径方向外側に移動した前記ストッパーが前記スパウトと係合するまで上方に移動し、これによって前記スパウトの内部空間に充填されていた溶液のうち第1の所定量の溶液が前記先端部から噴出され、前記下端プレートが押されなくなることによって、前記バネが前記レバー下部を押す力が減少するため前記ボスが前記レバーをより径方向内側へと押しながら戻り、前記さらに縮んだ状態のバネは、前記ボスが前記第2の凹部に入り込みかつ前記レバー返しで係止されるまで伸び、前記ボスが前記レバー及び前記ストッパーをより径方向内側に移動させたことによって前記ストッパーが解除され、前記ストッパーが解除された後、前記下端プレートが再度押されると、前記ピストンロッド及び前記ピストンが上方に移動し、前記スパウト内に残っていた第2の所定量の溶液が前記先端部から噴出される。 According to the injector provided with the double pushing mechanism of the present invention, in an initial state where the lower end plate is not pushed and the spring is not biased, the boss is accommodated in the first recess, When the lower end plate is pushed, the spring is compressed to engage with the lower portion of the lever, and while the lower end plate is pushed, the boss moves upward with the lower end plate, whereby the boss is moved by the boss When the lower end plate is pushed even after the bosses get over the lever barb and the boss gets over the lever barb, the spring is further contracted, and in this state, the lever and the lever lower portion are engaged by the spring and the lever lower portion. The stopper is positioned radially outward of the initial state against the boss, and the boss engages the flat portion of the lever, and the spring When the lower end plate is pushed in a further contracted state, the piston rod and the piston move upward until the stopper moved radially outward engages with the spout, whereby the internal space of the spout The first predetermined amount of the solution filled in the container is spouted from the tip and the lower end plate is not pressed, so that the force by which the spring pushes the lower portion of the lever is reduced. The lever is pushed back inward in the radial direction, and the spring in the further contracted state is extended until the boss enters the second recess and is locked by the lever, and the boss is the lever and the lever. By moving the stopper more radially inward, the stopper is released, and after the stopper is released, the lower end When the rate is pushed again, the piston rod and the piston moves upward, the solution of the second predetermined amount remaining in said spout is ejected from the tip.
 例えば、前記バネは、縮んだとき軸方向に対する角度が増大して径方向の長さを増大させる傾斜部を有していてもよい。また、前記ボスは、円柱状の先端部と、該円柱状の先端部を支持するため前記下端プレートから該先端部まで延在するロッドと、を備えていてもよい。さらに、少なくとも前記スパウト及び前記ピストンロッドの一部を覆うハウジングを備えていてもよい。好ましくは、前記ピストンロッドは、該ピストンロッドの外側表面から径方向外側に突出する第1の係止突起を備え、前記ハウジングは、該ハウジングの内壁から径方向内側に突出する第2の係止突起を備え、前記第1の係止突起及び前記第2の係止突起が係合することによって前記ピストンの下死点が画定される。操作性を良くするため、前記ハウジングは、径方向外側に突出する指掛用フランジを備えていてもよい。 For example, the spring may have an inclined portion which, when retracted, increases the angle with respect to the axial direction to increase the radial length. The boss may include a cylindrical tip and a rod extending from the lower end plate to the tip to support the cylindrical tip. Furthermore, a housing that covers at least a portion of the spout and the piston rod may be provided. Preferably, the piston rod comprises a first locking projection projecting radially outward from the outer surface of the piston rod, and the housing is a second locking projecting radially inward from the inner wall of the housing. A projection is provided, and the bottom dead center of the piston is defined by the engagement of the first locking projection and the second locking projection. In order to improve operability, the housing may be provided with a finger flange projecting radially outward.
 前記所定の物質は、カプセル内に密封し溶解液で溶解することで一定の目的を達成可能な溶液を生成できる任意の物質とすることができる。好ましくは、所定の物質は、固体粉末状の薬剤である。 The predetermined substance may be any substance that can be sealed in a capsule and dissolved in a solution to form a solution that can achieve a certain purpose. Preferably, the predetermined substance is a solid powder drug.
図1は、本発明の一実施形態に係る、噴出器と組み合わせられた用時溶解システムの長さ方向の断面図(一部除く)である。FIG. 1 is a longitudinal cross-sectional view (with parts removed) of an on-the-fly dissolution system combined with a sprayer, according to one embodiment of the present invention. 図2は、図1の用時溶解システムで溶液を生成し該溶液を噴出器に移した状態の用時溶解システムの長さ方向の断面図(一部を除く)である。FIG. 2 is a longitudinal sectional view (excluding a part) of the in-use dissolution system in a state where the solution is generated by the in-use dissolution system of FIG. 1 and the solution is transferred to the sprayer. 図3は、本実施形態に係る用時溶解システムの一構成要件であるカプセルホルダーの図であって、(a)は、平面図、(b)は一部断面図として示した正面図、(c)は第1の針部の斜視図である。FIG. 3 is a view of a capsule holder which is one of the configuration requirements of the in-use dissolution system according to the present embodiment, wherein (a) is a plan view and (b) is a front view as a partial sectional view; c) is a perspective view of the first needle portion. 図4は、本実施形態に係る用時溶解システムの一構成要件である溶解液ホルダーのハウジングを一部断面図として示した正面図である。FIG. 4 is a front view partially showing a housing of a solution holder, which is one of the configuration requirements of the in-use dissolution system according to the present embodiment, as a cross-sectional view. 図5は、図4の溶解液ホルダーのハウジングに装着される第2の針部の図であって、(a)は、一部断面図として示した正面図、(b)は底面図、(c)は斜視図である。FIG. 5 is a view of a second needle portion attached to the housing of the solution holder of FIG. 4, where (a) is a front view shown as a partial cross-sectional view, (b) is a bottom view, c) is a perspective view. 図6は、図4のハウジングに図5の第2の針部を装着することによって完成した溶解液ホルダーの一部断面図として示した正面図である。6 is a front view shown as a partial cross-sectional view of a solution holder completed by attaching the second needle portion of FIG. 5 to the housing of FIG. 4; 図7は、図6の溶解液ホルダーに充填された溶解液の流出ルートを示す断面図である。FIG. 7 is a cross-sectional view showing an outflow route of the solution filled in the solution holder of FIG. 図8は、カプセルを入れたカプセルホルダーと溶解液ホルダーとを連結させることによって、カプセルを装填した本実施形態に係る用時溶解システムを準備することを示した図である。FIG. 8 is a view showing preparation of the in-use dissolution system according to the embodiment loaded with the capsule by connecting the capsule holder containing the capsule and the solution holder. 図9は、図8のカプセルを装填した用時溶解システムの係止機構を示す断面図である。FIG. 9 is a cross-sectional view of the locking mechanism of the in-use dissolution system loaded with the capsule of FIG. 8; 図10は、本実施形態に係る用時溶解システムにおいて、噴出器からカプセルホルダー及び溶解液ホルダーの組み合わせを取り除いた状態を示す、当該噴出器の長さ方向の断面図である。FIG. 10 is a longitudinal sectional view of the squirter, showing a state in which the combination of the capsule holder and the solution holder is removed from the squirter in the in-use dissolution system according to the present embodiment. 図11は、図10の噴出器のプランジャ部を示す図であって、(a)は平面図、(b)は上端面図、左側面図、下端面図、(c)は底面図を示す。11 is a view showing a plunger portion of the jet device of FIG. 10, wherein (a) is a plan view, (b) is an upper end view, a left side view, a lower end view, and (c) shows a bottom view. . 図12は、図11のプランジャ部の一部を示す図であって、(a)は、図11(b)のA-A線の断面図、(b)は、図11(b)のB-B線の断面図、(c)は、図11(b)のCで示した部分の拡大詳細図、(d)は、図11(b)のDで示した部分の拡大詳細図である。12 is a view showing a part of the plunger portion of FIG. 11, wherein (a) is a cross-sectional view taken along the line AA of FIG. 11 (b), and (b) is a B of FIG. FIG. 11C is a cross-sectional view taken along the line B, FIG. 11C is an enlarged detail of a portion indicated by C in FIG. 11B, and FIG. . 図13は、図11の噴出器を初期状態から2回押し出しするときの該噴出器の動作をステップ(1)~(5)の順に示した図であり、このうち(1)~(3)は1回目の押し出し動作に関し、(4)は1回目の押し出しで係止した後に指を離したときの動作、並びに、(5)は2回目の押し出し動作に関する。FIG. 13 is a diagram showing the operation of the ejector of FIG. 11 when the ejector of FIG. 11 is pushed out twice from the initial state in the order of steps (1) to (5), of which (1) to (3) Is related to the first pushing operation, (4) is related to the operation when the finger is released after locking in the first pushing, and (5) relates to the second pushing operation. 図14は、図11の噴出器の別の使用例を示す図である。FIG. 14 is a view showing another use example of the sprayer of FIG. 図14の噴出器の別の使用例において、バイアルの準備段階を説明するための図である。FIG. 15 is a view for explaining the preparation step of the vial in another use example of the ejector of FIG. 14; 図16は、図4の溶解液ホルダーのハウジングに装着される、別の例に関する第2の針部の図であって、(a)は、一部断面図として示した正面図、(b)は斜視図である。Fig. 16 is a view of a second needle portion of another example attached to the housing of the solution holder of Fig. 4, wherein (a) is a front view shown as a partial sectional view, (b) Is a perspective view.
(用時溶解システム)
 以下、図面を参照して本発明の一実施形態に係る用時溶解システムを説明する。
(In-use dissolution system)
Hereinafter, the in-use dissolution system according to an embodiment of the present invention will be described with reference to the drawings.
 図1には、本発明の一実施形態に係る、用時にカプセル内に保管した所定の物質を溶解液で溶解することを可能とする用時溶解システム1が示されている。用時溶解システム1には該用時溶解システム1によって生成された溶液を噴出するための噴出器2が組み合わされており、用時溶解システム5(すなわち用時溶解噴出システム)が構成されている。 FIG. 1 shows an in-use dissolution system 1 according to an embodiment of the present invention, which enables a predetermined substance stored in a capsule at the time of use to be dissolved in a solution. The in-use dissolution system 1 is combined with the ejector 2 for ejecting the solution generated by the in-use dissolution system 1, and the in-use dissolution system 5 (that is, the in-use dissolution injection system) is configured. .
 用時溶解システム1は、中空の内部空間を有して筒状に形成されたカプセルホルダー3と、中空の内部空間を有して筒状に形成された溶解液ホルダー4と、を備えている。カプセルホルダー3は、薬剤粉末等の所定の物質をPTP等で包んでいるカプセル6を収容し、溶解液ホルダー4は、カプセル6内の薬剤粉末を溶解可能な溶解液7を収容している。図2は、用時溶解システム1でカプセル6を開封し、カプセル内に包まれていた物質を溶解液で溶解させて溶液を生成した状態を示しているが、詳細は後述する。 The in-use dissolution system 1 includes a capsule holder 3 formed in a cylindrical shape with a hollow internal space, and a dissolution liquid holder 4 formed in a cylindrical shape with a hollow internal space. . The capsule holder 3 accommodates a capsule 6 in which a predetermined substance such as a drug powder is wrapped in PTP or the like, and the solution holder 4 contains a solution 7 capable of dissolving the drug powder in the capsule 6. FIG. 2 shows a state in which the capsule 6 is opened by the dissolution system 1 at the time of use and the substance wrapped in the capsule is dissolved in the dissolution liquid to generate a solution, which will be described later in detail.
 カプセルホルダー3は、図3(a)、(b)に示されるように、一方の端部に形成された開口部10(第1の開口部)と、カプセルホルダー3の内部空間を仕切るように配置された第1の針部11とを備えている。開口部10付近のカプセルホルダー外周囲に亘ってシール部19が設けられている。シール部19は、後述する溶解液ホルダー4との嵌合時の密封のため設けられたものである。 As shown in FIGS. 3 (a) and 3 (b), the capsule holder 3 separates the opening 10 (first opening) formed at one end from the internal space of the capsule holder 3. And a first needle portion 11 disposed. A seal portion 19 is provided around the outer periphery of the capsule holder in the vicinity of the opening 10. The seal portion 19 is provided for sealing at the time of fitting with the solution holder 4 described later.
 第1の針部11は、該第1の針部を貫通する針孔部17を有し、該第1の針部11の針先端12は、開口部10に向いている。図3(c)には、第1の針部11の一例が示されている。図3(c)の例では、第1の針部11は、円錐の形状からその針先端12の側部が部分的に切削された形状を有しており、針先端12の切削された箇所には、針孔部17の針側の孔として貫通孔18が形成されている。例えば図3(a)、(c)の例では、貫通孔18は、120度毎に3か所形成されている。また、第1の針部11は、カプセルホルダー3と一体に成形されてもよい。 The first needle portion 11 has a needle hole portion 17 penetrating the first needle portion, and the needle tip 12 of the first needle portion 11 faces the opening 10. An example of the 1st needle part 11 is shown in Drawing 3 (c). In the example of FIG. 3C, the first needle portion 11 has a shape in which the side of its needle tip 12 is partially cut from the shape of a cone, and the cut portion of the needle tip 12 A through hole 18 is formed as a hole on the needle side of the needle hole portion 17 in the. For example, in the examples of FIGS. 3A and 3C, three through holes 18 are formed every 120 degrees. Also, the first needle portion 11 may be formed integrally with the capsule holder 3.
 第1の針部11の針先端12と開口部10との間のカプセルホルダー3の内部空間は、カプセル6を収容可能なカプセル収容室13を形成している。カプセル6をカプセル収容室13内でしっかりと保持するため、カプセル収容室13を画定するカプセルホルダー3の内壁には、該内壁から径方向内側に突出すると共に軸方向に沿って延びるリッジ20が形成されている。リッジ20は、図3(a)に示されるように、120度毎、3か所に設けられていてもよい。 An internal space of the capsule holder 3 between the needle tip 12 of the first needle portion 11 and the opening 10 forms a capsule accommodating chamber 13 capable of accommodating the capsule 6. In order to hold the capsule 6 firmly in the capsule chamber 13, the inner wall of the capsule holder 3 defining the capsule chamber 13 is formed with a ridge 20 which protrudes radially inward from the inner wall and extends along the axial direction. It is done. The ridges 20 may be provided at three positions every 120 degrees, as shown in FIG. 3 (a).
 カプセルホルダー3の開口10とは反対側の端部には開口部16(第3の開口部)が形成されており、開口部16付近のカプセルホルダー外壁にはフランジ16aが形成されている。また、カプセルホルダー3は、直径の小さい筒状の部分である小径部3aと、直径のより大きい筒状の部分である大径部3bとに区分される。第1の針部11と開口16との間の内部空間は、噴出器2の先端部が挿入される噴出器室(14,15)を形成している。大径部3b側の噴出器室15には、噴出器2の先端部を保持するためのリッジ21が形成されている。 An opening 16 (third opening) is formed at the end of the capsule holder 3 opposite to the opening 10, and a flange 16a is formed on the capsule holder outer wall near the opening 16. Further, the capsule holder 3 is divided into a small diameter portion 3a which is a cylindrical portion with a small diameter and a large diameter portion 3b which is a cylindrical portion with a large diameter. The internal space between the first needle portion 11 and the opening 16 forms a jet chamber (14, 15) into which the tip of the jet 2 is inserted. A ridge 21 for holding the front end of the jet 2 is formed in the jet chamber 15 on the large diameter portion 3 b side.
 溶解液ホルダー4は、図6に示されるように、一方の端部において内部空間を閉塞する閉塞端部22と、該閉塞端部22の反対側の端部に形成された開口部23(第2の開口部)と、溶解液ホルダー4の内部空間で摺動可能な第2の針部25とを備えている。第2の針部25の針先端27は、開口部23に向いている。また、第2の針部25を溶解液ホルダー4の内部空間で摺動可能に保持するため、図4に示されるように、溶解液ホルダー4の内壁には、第2の針部25の側壁と接触するように内周囲に亘って延在する環状リッジ24が形成されている。本実施形態では、第2の針部25の安定した保持を確実にするため、2本の環状リッジ24が形成されているが、本発明はこれに限定されない。 As shown in FIG. 6, the solution holder 4 has a closed end 22 closing the inner space at one end and an opening 23 formed at the opposite end of the closed end 22 An opening 2) and a second needle portion 25 slidable in the internal space of the solution holder 4 are provided. The needle tip 27 of the second needle 25 faces the opening 23. Further, in order to hold the second needle portion 25 slidably in the internal space of the solution holder 4, as shown in FIG. 4, the inner wall of the solution holder 4 is provided with a side wall of the second needle portion 25. An annular ridge 24 is formed extending around the inner periphery so as to be in contact therewith. In the present embodiment, two annular ridges 24 are formed in order to ensure stable holding of the second needle portion 25, but the present invention is not limited to this.
 第2の針部25は、図5(a)、(c)に示されるように、ベース26と該ベース26から延在する針先端27と、ベース26の外周囲に亘って延在するシール部29とを備えている。また、図5(b)、(c)に示されるように、ベース26の側壁には、シール部29の下方で軸方向に延在する液流通用溝28が形成されている。液流通用溝28は、複数形成されていてもよい。 The second needle portion 25 has a base 26, a needle tip 27 extending from the base 26, and a seal extending over the outer periphery of the base 26, as shown in FIGS. 5 (a) and 5 (c). And a unit 29. Further, as shown in FIGS. 5B and 5C, on the side wall of the base 26, there is formed a liquid flow passage groove 28 extending in the axial direction below the seal portion 29. As shown in FIG. A plurality of liquid flow grooves 28 may be formed.
 また、開口部23は、カプセルホルダー3の小径部3aを挿入可能にサイズが定められており、カプセルホルダー3のシール部19が溶解液ホルダー4の内壁と接触することにより、密封性を維持しながら、カプセルホルダー3と溶解液ホルダー4とを互いに対して摺動することが可能になっている。 The opening 23 is sized so as to allow insertion of the small diameter portion 3 a of the capsule holder 3, and the sealing portion 19 of the capsule holder 3 maintains the sealing performance by coming into contact with the inner wall of the solution holder 4. However, it is possible to slide the capsule holder 3 and the solution holder 4 with respect to each other.
 再び図6を参照すると、第2の針部25の底面と閉塞端部22との間の内部空間は、溶解液を入れるための溶解液室30を形成している。なお、溶解液室30には、溶解液7の他に、空気31が入り込むこともある。この状態では、シール部29(図5(a)、(c))は、溶解液ホルダー4の内壁には接触しておらず、閉塞端部22に近い上側の環状リッジ24(図4)と係合することによって、溶解液室30を密封している。 Referring again to FIG. 6, the internal space between the bottom of the second needle 25 and the closed end 22 forms a solution chamber 30 for containing a solution. In addition to the solution 7, air 31 may enter the solution chamber 30. In this state, the seal portion 29 (FIGS. 5A and 5C) is not in contact with the inner wall of the solution holder 4, and the upper annular ridge 24 (FIG. 4) near the closed end 22 By engaging, the solution chamber 30 is sealed.
 図7に示されるように、シール部29が上側の環状リッジ24から離れると、第2の針部25は、該第2の針部25の側壁と溶解液室30の内壁との間に、溶解液が溶解液室30からC方向に沿って第2の針部の先端側へと出るための溶解液通路を形成する。すなわち、溶解液は、溶解液室30から、第2の針部の側壁上部と溶解液室30の内壁との間に形成された小さい隙間を通り、シール部29を越え、第2の針部と接触するリッジ24によっては完全に閉塞されない液流通用溝28を通って、針先端側へと流れることが可能である。勿論、第2の針部25それ自身を貫通する貫通孔(図示せず)を溶解液通路として形成することも可能である。 As shown in FIG. 7, when the seal portion 29 separates from the upper annular ridge 24, the second needle portion 25 is positioned between the side wall of the second needle portion 25 and the inner wall of the solution chamber 30, A solution passage is formed to allow the solution to exit from the solution chamber 30 along the C direction toward the tip end of the second needle portion. That is, the solution passes from the solution chamber 30 through the small gap formed between the upper side wall of the second needle portion and the inner wall of the solution chamber 30, and passes the seal portion 29, and the second needle portion It is possible to flow toward the tip of the needle through the fluid communication groove 28 which is not completely closed by the ridge 24 in contact with it. Of course, it is also possible to form a through hole (not shown) which penetrates the second needle portion 25 itself as a solution passage.
 以上説明したカプセルホルダー3及び溶解液ホルダー4から用時溶解システム1を組み立てる際には、図8に示されるように、カプセル6をカプセルホルダー3のカプセル収容室に入れ、カプセルホルダー3の開口部10側の端部を、溶解液室30に溶解液7を入れた溶解液ホルダー4の開口部23から挿入する。このとき、カプセル6は、対向した第2の針部25の針先端27と第1の針部11の針先端12との間に配置される。図8の組み立てた用時溶解システムは図1の用時溶解システムに対応しており、カプセル6は、第2の針部25の針先端27と第1の針部11の針先端12とに接触した状態に配置されている。 When assembling the in-use dissolution system 1 from the capsule holder 3 and the solution holder 4 described above, the capsule 6 is put in the capsule storage chamber of the capsule holder 3 as shown in FIG. The end on the 10 side is inserted from the opening 23 of the solution holder 4 in which the solution 7 is placed in the solution chamber 30. At this time, the capsule 6 is disposed between the needle tip 27 of the facing second needle portion 25 and the needle tip 12 of the first needle portion 11. The assembled in-use dissolution system of FIG. 8 corresponds to the in-use dissolution system of FIG. 1, and the capsule 6 is formed of the needle tip 27 of the second needle portion 25 and the needle tip 12 of the first needle portion 11. It is placed in contact.
 図1及び図8に示される上記状態を維持するため、図9に示されるように、カプセルホルダー3の開口部10付近の外壁には前述したシール部19が形成され、溶解液ホルダーの内壁には段差33が形成されている。カプセルホルダー3を溶解液ホルダー4内に挿入するとき、シール部19が段差33と係合することによりカプセルホルダー3及び溶解液ホルダー4が一旦係止される。当該係止位置において、図1及び図8に示されるように、第1の針部11の針先12及び第2の針部25の針先端27がカプセル6と接触する位置(初期状態)となる。この初期状態から所定以上の力を加えることによってシール部19が段差33を乗り越え、カプセルホルダー3及び溶解液ホルダー4がさらに接近することになる。 In order to maintain the above state shown in FIGS. 1 and 8, as shown in FIG. 9, the seal portion 19 described above is formed on the outer wall near the opening 10 of the capsule holder 3 and on the inner wall of the solution holder. A step 33 is formed. When the capsule holder 3 is inserted into the solution holder 4, the seal portion 19 engages with the step 33 to temporarily lock the capsule holder 3 and the solution holder 4. In the locked position, as shown in FIGS. 1 and 8, a position (initial state) where the needle tip 12 of the first needle portion 11 and the needle tip 27 of the second needle portion 25 contact the capsule 6 Become. By applying a predetermined force or more from this initial state, the seal portion 19 gets over the step 33 and the capsule holder 3 and the solution holder 4 come closer.
 次に、本実施形態に係る用時溶解システム1の作用を説明する。 Next, the operation of the in-use dissolution system 1 according to the present embodiment will be described.
 図2に示されるように、図1に示す初期状態から、溶解液ホルダー4を矢印A方向に所定以上の力で押す。この操作は、例えばフランジ16aに人差し指及び中指を掛け、溶解液ホルダー4の閉塞端部を親指で押すことによって実現することができる。 As shown in FIG. 2, from the initial state shown in FIG. 1, the solution holder 4 is pushed in the direction of arrow A with a predetermined force or more. This operation can be realized, for example, by putting the forefinger and the middle finger on the flange 16a and pushing the closed end of the solution holder 4 with the thumb.
 上記のような押し下げにより、溶解液ホルダー4とカプセルホルダー3とはより接近し、第1の針部11の針先12及び第2の針部25の針先端27がカプセル6と接触する位置からさらに互いに接近するため、カプセル6の外皮を突き破り、カプセル6を開封する。開封されたカプセル6からは内部の薬剤粉末がカプセル収容室13内に解放される。 From the position where the solution holder 4 and the capsule holder 3 move closer to each other and the needle tip 12 of the first needle portion 11 and the needle tip 27 of the second needle portion 25 come in contact with the capsule 6 by the above depression. In order to further approach each other, the shell of the capsule 6 is pierced and the capsule 6 is opened. The drug powder inside is released from the opened capsule 6 into the capsule storage chamber 13.
 一方、第2の針部25がカプセル6を穿刺する際に該第2の針部25が抵抗を受け、押し込まれて移動する溶解液ホルダー4に対して相対的に閉塞端部22に近い上側に移動する。これによって図7に示されるように溶解液室30の密封が解除され、溶解液が液流通用溝28を通ってカプセル収容室13へと流れる。カプセル収容室13に流れ込んだ溶解液は、解放された薬剤粉末を溶解し、溶液9が生成される。図2に示されるように、溶解液ホルダー4のカプセルホルダー3への押し込みは、第2の開口部の周囲の溶解液ホルダー4の縁部がカプセルホルダー3の大径部3bと係合することによって、係止される。この係止時点では、所定容積を維持したカプセル収容室13内に溶液が入った状態となっている。従って、本実施形態によって、用時にカプセル6内に保管した薬剤粉末を溶解液で溶解することを可能とする用時溶解システムが実現された。 On the other hand, when the second needle portion 25 punctures the capsule 6, the second needle portion 25 receives resistance, and the upper side closer to the closed end 22 relatively to the solution holder 4 which is pushed in and moved. Move to As a result, as shown in FIG. 7, the sealing of the solution chamber 30 is released, and the solution flows to the capsule storage chamber 13 through the groove 28 for solution passage. The solution flowing into the capsule storage chamber 13 dissolves the released drug powder, and a solution 9 is generated. As shown in FIG. 2, when the solution holder 4 is pushed into the capsule holder 3, the edge of the solution holder 4 around the second opening engages with the large diameter portion 3 b of the capsule holder 3. Is locked. At this locking point, the solution is in the capsule storage chamber 13 maintaining the predetermined volume. Therefore, according to the present embodiment, an in-use dissolution system is realized which enables the drug powder stored in the capsule 6 to be dissolved at the time of use with the solution.
 図2では、噴出器2のピストン38をB方向に引くことによって、カプセル収容室13内の溶液を噴出器2のスパウト36内に吸引した状態が示されている。本実施形態に係る噴出器について以下に説明する。 In FIG. 2, the state in which the solution in the capsule storage chamber 13 is sucked into the spout 36 of the ejector 2 is shown by pulling the piston 38 of the ejector 2 in the B direction. The ejector which concerns on this embodiment is demonstrated below.
(噴出器)
 図10には、用時溶解システム1から取り外された噴出器2が示されている。
(Squirter)
FIG. 10 shows the jet 2 removed from the in-use dissolution system 1.
 同図に示されるように、噴出器2は、噴出器2の用時溶解システム1への取り付け時には噴出器室(図3(b)の14)内に脱着可能に係合される先端部35と、先端部35から後方に延在するスパウト36と、スパウト36の内部空間内を軸方向に摺動可能に構成されたピストン38と、先端部35、スパウト36及びピストン38を覆うハウジング37と、ピストンから軸方向に延在するプランジャ部32(図11)と、を備えている。プランジャ部32は、プランジャ部を操作するためのプランジャ操作部50を備えている。 As shown in the figure, the jet 2 is a tip 35 which is detachably engaged in the jet chamber (14 of FIG. 3 (b)) when the jet 2 is attached to the in-use melting system 1. A spout 36 extending rearward from the tip 35, a piston 38 axially slidable in the internal space of the spout 36, and a housing 37 covering the tip 35, the spout 36 and the piston 38. And a plunger portion 32 (FIG. 11) extending axially from the piston. The plunger portion 32 includes a plunger operating portion 50 for operating the plunger portion.
 先端部35は、噴出器室14内に係合されたときその針孔部17(図3(b))と整合する先端孔34を有する。先端孔34は、導管61を介してスパウト36の内部空間と連通している。また、噴出器2の用時溶解システム1への取り付け時には、ハウジング37の上部も噴出器室(図3(b)の15)内に脱着可能に係合されている。また、ハウジング37は、径方向外側に突出する指掛用フランジ42を備える。 The tip portion 35 has a tip hole 34 that aligns with the needle hole 17 (FIG. 3 (b)) when engaged within the jet chamber 14. The tip hole 34 communicates with the internal space of the spout 36 via the conduit 61. Further, when the ejector 2 is attached to the in-use melting system 1, the upper portion of the housing 37 is also detachably engaged in the ejector chamber (15 of FIG. 3 (b)). Further, the housing 37 is provided with a finger flange 42 that protrudes radially outward.
 噴出器2を用時溶解システム1に取り付けている時には、プランジャ部32を、スパウト36から離れるように引くことによってピストン38が先端部35から離れるように移動し、これによって先端孔34及び導管61を通ってカプセル収容室13内の溶液がスパウト36の内部空間に流入する。 When the ejector 2 is attached to the dissolution system 1 at the time of use, the piston 38 is moved away from the tip 35 by pulling the plunger 32 away from the spout 36, whereby the tip hole 34 and the conduit 61 The solution in the capsule storage chamber 13 flows into the internal space of the spout 36 through the
 一方、噴出器2を用時溶解システム1から取り外している時には、プランジャ部32を、スパウト36に近づけるように押すことによってピストン38が先端部35に接近するように移動し、これによってスパウト36内の溶液が導管61及び先端孔34を通って外部へと噴出する。なお、先端部35を、溶液を噴霧するためのノズル部として構成することもできる。 On the other hand, when the ejector 2 is removed from the in-use dissolution system 1, the piston 38 is moved closer to the tip 35 by pushing the plunger 32 closer to the spout 36, whereby the inside of the spout 36 Solution jets out through the conduit 61 and the tip hole 34. In addition, the front-end | tip part 35 can also be comprised as a nozzle part for spraying a solution.
 本実施形態に係る噴出器2は、吸引した溶液をそれぞれ第1の所定量及び第2の所定量毎、切り替え操作無しで2回噴出することが可能な2回押し出し機構を備えている。 The squirter 2 according to the present embodiment is provided with a double-pushing mechanism capable of jetting the suctioned solution twice for each of the first predetermined amount and the second predetermined amount without switching operation.
 以下、2回押し出し機構を備える噴出器2のプランジャ部32に関する構成を図10、11及び12を用いて詳しく説明する。 Hereinafter, the structure regarding the plunger part 32 of the ejector 2 provided with a twice pushing mechanism is demonstrated in detail using FIG.10, 11 and 12. FIG.
 図10に示されるように、プランジャ部32は、ピストン38から軸方向に下方に延在するピストンロッド39と、ピストンロッド39と並んでピストン38から下方に延在するレバー45と、ピストンロッド39及びレバー45の下方に配置された下端プレート51と、スパウトリング43と、該スパウトリング43内に配置された2回押し出し機構の主要部と、を備えている。また、ピストンロッド39は、該ピストンロッド39の外側表面から径方向外側に突出する第1の係止突起41を備え、ハウジング37は、該ハウジング37の内壁から径方向内側に突出する第2の係止突起40を備え、第1の係止突起41及び第2の係止突起40が係合することによってピストン38の下死点が画定され、ピストン38の抜け止めを図ることができる。なお、ピストン38の先端部にはスパウト内部を密封状態で摺動するためのシール部48(図11(c)、図12(d))が形成されている。 As shown in FIG. 10, the plunger portion 32 includes a piston rod 39 extending axially downward from the piston 38, a lever 45 extending downward from the piston 38 in line with the piston rod 39, and a piston rod 39. And a lower end plate 51 disposed below the lever 45, a spout ring 43, and a main portion of a double pushing mechanism disposed in the spout ring 43. The piston rod 39 further includes a first locking projection 41 projecting radially outward from the outer surface of the piston rod 39, and the housing 37 is a second projecting radially inward from the inner wall of the housing 37. A locking projection 40 is provided, and the lower dead center of the piston 38 is defined by the engagement of the first locking projection 41 and the second locking projection 40, and the piston 38 can be prevented from coming off. At the end of the piston 38, a seal 48 (FIGS. 11 (c) and 12 (d)) for sliding the spout inside in a sealed state is formed.
 図11及び図12(特に図11(b)及び図12(c))に示されるように、スパウトリング43内に配置されたプランジャ操作部50は、下端プレート51から上方にレバー45と係合可能に延在するボス54と、下端プレート51とピストンロッド39の下端との間に設けられ、縮むときに拡径するバネ52と、を備えている。また、2回押し出し機構の構成要件の一つであるレバー45は、ピストンロッド39と並んだ位置から径方向に変位するように撓むことが可能であり、レバー45は、該レバーの下端に設けられ、拡径したバネの傾斜部52aと係合可能なレバー下部55と、レバー下部55よりも上方に形成され、径方向外側のボス54の側に突出するレバー返し56と、レバー下部55とレバー返し56との間に形成された第1の凹部57と、レバー返し56の上方に隣接して形成された第2の凹部58と、第2の凹部58の上方に形成された平坦部59と、平坦部59よりも上方のレバー45の所定の位置で径方向外側に突出するストッパー47と、を備えている。バネ52は、縮んだとき軸方向に対する角度が増大して径方向の長さを増大させるバネの傾斜部52a(図12(c))を有し、ボス54は、円柱状の先端部(54)と、該円柱状の先端部を支持するため下端プレート51から該先端部まで延在するロッド53と、を備えている。 As shown in FIGS. 11 and 12 (particularly in FIGS. 11 (b) and 12 (c)), the plunger operating portion 50 disposed in the spout ring 43 engages with the lever 45 upward from the lower end plate 51. A boss 54 which can extend is provided, and a spring 52 which is provided between the lower end plate 51 and the lower end of the piston rod 39 and which expands in diameter when it is contracted. Further, the lever 45 which is one of the requirements of the double pushing mechanism can be bent so as to be displaced in the radial direction from the position aligned with the piston rod 39, and the lever 45 is provided at the lower end of the lever. A lower lever portion 55 is provided and engageable with the inclined portion 52a of the expanded spring, and a lever return 56 which is formed above the lower lever portion 55 and protrudes toward the radially outer boss 54, and the lower lever 55 The first recess 57 formed between the first and second levers 56, the second recess 58 formed adjacent to the upper side of the lever 56, and the flat portion formed above the second recess 58 And a stopper 47 projecting radially outward at a predetermined position of the lever 45 above the flat portion 59. The spring 52 has an inclined portion 52a (FIG. 12 (c)) of the spring which, when compressed, increases the angle with respect to the axial direction to increase the radial length, and the boss 54 has a cylindrical tip (54). And a rod 53 extending from the lower end plate 51 to the tip to support the cylindrical tip.
 次に、本実施形態に係る噴出器2の2回押し出し機構の作用について図13を用いて説明する。 Next, the operation of the double pushing mechanism of the jet device 2 according to the present embodiment will be described with reference to FIG.
 噴出器2は、例えばフランジ42(図10)に人指し指及び中指を掛け、下端プレート51を親指で押すことによって、スパウト36内の溶液を押し出すことができる。 The sprayer 2 can push out the solution in the spout 36, for example, by putting the index finger and the middle finger on the flange 42 (FIG. 10) and pushing the lower end plate 51 with the thumb.
 図13に示されるように、下端プレート51が押されずにバネ52が付勢されていない初期状態では、ボス54は第1の凹部57内に収まっている。この初期状態では、ストッパー47は、スパウトの下端縁と係合可能な径方向位置よりも径方向内側に位置している。 As shown in FIG. 13, in the initial state where the lower end plate 51 is not pressed and the spring 52 is not biased, the boss 54 is accommodated in the first recess 57. In this initial state, the stopper 47 is located radially inward of the radial position that can be engaged with the lower end edge of the spout.
 次に下端プレート51が押されたとき(ステップ(1))、バネ52が縮んで径方向外側に拡径するため、そのバネの傾斜部52aがレバー下部55と係合する(ステップ(1))。下端プレート51が押されている間に、ボス54は下端プレート51と共に上方に移動し、これによってボス54は、ロッド53が径方向外側に反り返りながらレバー返し56を乗り越えようとする。 Next, when the lower end plate 51 is pressed (step (1)), the spring 52 is contracted and radially expanded outward, so the inclined portion 52a of the spring engages with the lever lower portion 55 (step (1)) ). While the lower end plate 51 is pressed, the boss 54 moves upward with the lower end plate 51, whereby the boss 54 tries to get over the lever bar 56 while the rod 53 is bent radially outward.
 ボス54がレバー返し56を乗り越えた後も下端プレート51が押されるとき(ステップ(2))、バネ52はさらに縮んだ状態(例えば最縮状態)となり、この状態においてバネの傾斜部52aとレバー下部55との係合によりレバー45及びストッパー47はボス54が径方向内側へと戻ろうとする力に抗して初期状態よりも径方向外側に位置すると共に、ボス54がレバー45の平坦部59に係合する。このときストッパー47は、スパウト36の下端縁と係合可能な径方向位置にまで移動している。 When the lower end plate 51 is pushed even after the boss 54 gets over the lever return 56 (step (2)), the spring 52 is in a further contracted state (for example, the fully contracted state). In this state, the inclined portion 52a of the spring and the lever Due to the engagement with the lower portion 55, the lever 45 and the stopper 47 are positioned radially outward of the initial state against the force of the boss 54 trying to return radially inward, and the boss 54 is a flat portion 59 of the lever 45. Engage in At this time, the stopper 47 has moved to a radial position where it can be engaged with the lower end edge of the spout 36.
 バネ52が上記さらに縮んだ状態(例えば最縮状態)で下端プレート51が押されるとき(ステップ(3))、この押した力は、もはやバネ52により吸収できなくなるため、ピストンロッド39及びピストン38を上方向に移動させるために使用される。すなわち、ピストンロッド39及びピストン38が、径方向外側に移動したストッパー47がスパウト36と係合するまで上方に移動し、これによってスパウト36の内部空間に充填されていた溶液のうち第1の所定量の溶液が導管61を通って先端孔34から噴出される。 When the lower end plate 51 is pushed (step (3)) in the state where the spring 52 is further contracted (for example, the fully contracted state), the pushed force can no longer be absorbed by the spring 52. Is used to move upwards. That is, the piston rod 39 and the piston 38 move upward until the stopper 47 moved radially outward engages with the spout 36, whereby the first portion of the solution filled in the internal space of the spout 36 A metered amount of solution is expelled from tip hole 34 through conduit 61.
 第1回目の噴出が終了した後、一旦、指を下端プレート51から離す(ステップ(4))。下端プレート51が押されなくなることによって、バネの傾斜部52aがレバー下部55を押す力が減少するためボス54がレバー45をより径方向内側へと押しながら戻り、さらに縮んだ状態のバネ52は、ボス54が第2の凹部58に入り込みかつレバー返し56で係止されるまで伸びることになる。このとき、ボス54がレバー45及びストッパー47をより径方向内側に移動させているためストッパー47が解除される。 After the first ejection, the finger is once released from the lower end plate 51 (step (4)). When the lower end plate 51 is not pushed, the force by which the inclined portion 52a of the spring pushes the lever lower portion 55 is reduced, so that the boss 54 pushes back the lever 45 more inward in the radial direction. The boss 54 extends into the second recess 58 until it is locked by the lever bar 56. At this time, since the boss 54 moves the lever 45 and the stopper 47 more inward in the radial direction, the stopper 47 is released.
 ストッパー47が解除された後、下端プレート51が再度押されるとき(ステップ(5))、ピストンロッド39及びピストン38が上方に移動し、スパウト36内に残っていた第2の所定量の溶液が先端孔34から噴出される。 After the stopper 47 is released, when the lower end plate 51 is pushed again (step (5)), the piston rod 39 and the piston 38 move upward, and the second predetermined amount of solution remaining in the spout 36 It spouts from the tip hole 34.
 以上説明した噴出器2を用いた用時溶解システムを用いれば、例えばワクチンなどで使用時に粉末剤と溶解液とを混合し、溶液を噴出器2のスパウト側に移動させ、鼻の2穴の鼻腔内にそれぞれ噴霧させて投与することができる。第1の所定量と第2の所定量とは等しくてもよいが、任意好適に異なる比率に変更可能である。 If the in-use dissolution system using the ejector 2 described above is used, for example, the powder and the solution are mixed at the time of use in a vaccine etc., and the solution is moved to the spout side of the ejector 2 Each can be administered by spraying into the nasal cavity. The first predetermined amount and the second predetermined amount may be equal to each other, but may be arbitrarily changed to different ratios.
 さらに本実施形態に係る噴出器2は、バネの傾斜部52aによりレバー45を押し広げるので、従来技術の2回押し出し機構と比べて、確実にストッパー47の係止機能を働かせることが可能となる。また、ボス54によりレバー45を内側に引き込むことにより確実にストッパー45を解除することが可能となる。 Furthermore, since the ejector 2 according to the present embodiment spreads the lever 45 by the inclined portion 52a of the spring, the locking function of the stopper 47 can be reliably operated as compared with the double pushing mechanism of the prior art. . Further, by pulling the lever 45 inward by the boss 54, the stopper 45 can be reliably released.
(噴出器の他の使用例)
 以上説明した噴出器2は、用時溶解システム1以外の用途にも使用することが可能である。
(Another use example of a sprayer)
The sprayer 2 described above can be used for applications other than the in-use dissolution system 1.
 図14には、バイアル内の薬液を吸い取って投与するための噴出器2の使用例が示されている。また、図15には、バイアル内で薬液を準備するときの工程が示されている。 FIG. 14 shows an example of use of the sprayer 2 for sucking and dispensing a drug solution in a vial. Further, FIG. 15 shows a process of preparing a drug solution in a vial.
 先ず、図15に示されるように、バイアル80には、粉末薬剤77が入れられており、キャップ82で封止されることにより、湿気が入り込まない状態で保管されている。薬液を作る際には、溶解液を入れた注射器90の針91をキャップ82に刺して溶解液をバイアル80内に注入する。注入された溶解液は粉末薬剤77を溶解し、薬液(溶液)81が生成される。噴出器を使用する際には、バイアル80と噴出器との接続アダプター70をバイアル80に装填する。 First, as shown in FIG. 15, the vial 80 contains a powdered drug 77 and is sealed with a cap 82 so that moisture is not stored therein. When preparing a drug solution, the needle 91 of the syringe 90 containing the solution is pierced through the cap 82 to inject the solution into the vial 80. The injected solution dissolves the powdered drug 77 to produce a drug solution (solution) 81. When using the ejector, the connection adapter 70 between the vial 80 and the ejector is loaded into the vial 80.
 図14に示されるように、接続アダプター70は、バイアル側保持部71aと、噴出器側保持部71bとを備えている。バイアル側保持部71aには、穿刺可能なキャップ82で封止された、薬液81入りのバイアル80を、キャップ側から挿入するための凹部が形成されており、該凹部の中央部からは斜頭切形の針部72が延在している。針部72には、接続アダプター70に亘って貫通する貫通孔73が形成されている。また、噴出器側保持部71bには、上記説明した噴出器2の先端部35を挿入するための凹部が形成されている。薬液81入りのバイアル80が接続アダプター70のバイアル側保持部71aに嵌合されたとき、キャップ82は針部72によって開封される。この状態で、噴出器2が接続アダプター70の噴出器側保持部71bに嵌合されたとき、接続アダプター70の針部72の貫通孔73と噴出器2の先端孔34とは整合する。これによって、薬液81は、針部72の貫通孔73を通って噴出器2の先端孔34に至ることが可能となる。 As shown in FIG. 14, the connection adapter 70 includes a vial side holding portion 71 a and a jetting device side holding portion 71 b. The vial side holding portion 71a is formed with a recess for inserting the vial 80 containing the drug solution 81 and sealed with the puncturable cap 82 from the cap side, and the oblique head from the central portion of the recess A truncated needle 72 extends. In the needle portion 72, a through hole 73 penetrating the connection adapter 70 is formed. Moreover, the recessed part for inserting the front-end | tip part 35 of the ejector 2 demonstrated above is formed in the ejector side holding part 71b. When the vial 80 containing the drug solution 81 is fitted to the vial side holding portion 71 a of the connection adapter 70, the cap 82 is opened by the needle portion 72. In this state, when the ejector 2 is fitted to the ejector side holding portion 71b of the connection adapter 70, the through hole 73 of the needle portion 72 of the connection adapter 70 and the tip hole 34 of the ejector 2 are aligned. As a result, the drug solution 81 can reach the tip hole 34 of the sprayer 2 through the through hole 73 of the needle portion 72.
 図14に示された状態で、ピストンロッド39を下方に引くことによって、ピストン38がスパウト36(図2、図13参照)内で下方に移動し、バイアル80内の薬液81は、針部72の貫通孔73及び噴出器2の先端孔34を通ってスパウト36内に吸引される。薬液吸引後に噴出器2を接続アダプター70から取り出せば、上記説明した通り、薬液81を2回に分けて噴出することができる。 In the state shown in FIG. 14, the piston 38 is moved downward in the spout 36 (see FIGS. 2 and 13) by pulling the piston rod 39 downward, and the drug solution 81 in the vial 80 has a needle portion 72. The spout 36 is sucked through the through hole 73 and the tip hole 34 of the sprayer 2. If the squirter 2 is taken out of the connection adapter 70 after the liquid chemical suction, as described above, the liquid drug 81 can be ejected twice in two steps.
 本実施形態に係る噴出器2は、図14の例の他にも考えられる。例えば粘度のある薬液が入ったガラス瓶に接続して内容液を吸い上げて取り出し、2回に分けて噴出するようにしてもよい。また、検体を吸い取り反応液A・Bに分注する等の試薬用途にも使用することができる。 The ejector 2 which concerns on this embodiment can be considered besides the example of FIG. For example, it may be connected to a glass bottle containing a drug solution having viscosity, and the content liquid may be sucked and taken out, and may be ejected twice in two steps. In addition, it can be used for reagent applications such as sucking a sample and dispensing it to reaction solutions A and B.
 以上が本発明の実施形態であるが、本発明は、上記実施形態にのみ限定されるものではなく、本発明が意図した範囲内において任意好適に変更可能である。 The above is the embodiment of the present invention, but the present invention is not limited to the above embodiment, and can be arbitrarily changed within the scope intended by the present invention.
 例えば、上記例において、溶解液ホルダーの第2の針部25の側壁には、溶解液を溶解液室から出すため液流通用溝28が形成されている(図5(a)~(c))。本発明では、この例のみに限定されず、第2の針部25のシール部29よりも針先端27に近い位置から該針先端27に向かって溶解液を流すための液流通用通路が形成されていればよい。このような液流通用通路として、例えば、図16(a)、(b)に示されるように、液流通用溝28のように側壁の溝ではなく、第2の針部の内部を貫通する液流通用の貫通孔28aとして形成してもよい。液流通用の貫通孔28aは、シール部29の下方の位置からベース26の側壁を径方向に貫通し、ベース内部で軸方向への貫通孔となって、針先端27の針頂点に近接する位置まで貫通する。 For example, in the above example, a groove 28 for liquid flow is formed on the side wall of the second needle portion 25 of the solution holder for taking out the solution from the solution chamber (FIGS. 5A to 5C) ). In the present invention, the present invention is not limited to only this example, and a passage for liquid flow is formed to flow the solution toward the needle tip 27 from a position closer to the needle tip 27 than the seal portion 29 of the second needle portion 25. It should be done. For example, as shown in FIGS. 16 (a) and 16 (b), such a fluid flow passage passes through the inside of the second needle portion instead of the groove of the side wall like the fluid flow groove 28. You may form as the through-hole 28a for liquid distribution. The through hole 28a for liquid flow radially penetrates the side wall of the base 26 from the position below the seal portion 29, and becomes an axial through hole inside the base and approaches the needle apex of the needle tip 27 It penetrates to the position.
  1  用時溶解システム
  2  噴出器
  3  カプセルホルダー
  3a 小径部
  3b 大径部
  4  溶解液ホルダー
  5  用時溶解噴出システム
  6  カプセル
  7  溶解液
  9  溶液
 10  開口部(第1の開口部)
 11  第1の針部
 12  針先端
 13  カプセル収容室
 14、15  噴出器室
 16  開口部(第3の開口部)
 16a フランジ
 17  針孔部
 18  貫通孔
 19  シール部
 20  リッジ
 21  リッジ
 22  閉塞端部
 23  開口部(第2の開口部)
 24  環状リッジ
 25  第2の針部
 26  ベース
 27  針先端
 28  液流通用溝(液流通用通路)
 28a  液流通用の貫通孔(液流通用通路)
 29  シール部
 30  溶解液室
 31  空気
 32  プランジャ部
 33  段差
 34  先端孔
 35  先端部
 36  スパウト
 37  ハウジング
 38  ピストン
 39  ピストンロッド
 40  第2の係止突起
 41  第1の係止突起
 42  指掛用フランジ
 43  スパウトリング
 45  レバー
 47  ストッパー
 48  シール部
 50  プランジャ操作部
 51  下端プレート
 52  バネ
 52a バネの傾斜部
 53  ロッド
 54  ボス
 55  レバー下部
 56  レバー返し
 57  第1の凹部
 58  第2の凹部
 59  平坦部
 60  溶液
 61  導管
 70  接続アダプター
 71a バイアル側保持部
 71b 噴出器側保持部
 72  針部
 73  貫通孔
 77  薬剤粉末
 80  バイアル
 81  薬液
 82  キャップ
 90  注射器
 91  針
                                                                                  
DESCRIPTION OF SYMBOLS 1 Dissolution system in use 2 Ejector 3 Capsule holder 3a Small diameter part 3b Large diameter part 4 Dissolution liquid holder 5 Dissolution system 5 in use 6 Capsule 7 Dissolution liquid 9 Solution 10 Opening (first opening)
11 first needle portion 12 needle tip 13 capsule storage chamber 14, 15 jet chamber 16 opening (third opening)
16 a Flange 17 needle hole 18 through hole 19 seal 20 ridge 21 ridge 22 closed end 23 opening (second opening)
24 annular ridge 25 second needle portion 26 base 27 needle tip 28 groove for liquid flow (passage for liquid flow)
28a Through hole for liquid flow (passage for liquid flow)
29 seal portion 30 solution chamber 31 air 32 plunger portion 33 step 34 tip hole 35 tip portion 36 spout 37 housing 38 piston 39 piston rod 40 second locking protrusion 41 first locking protrusion 42 finger flange 43 spout Ring 45 Lever 47 Stopper 48 Seal 50 Plunger operating portion 51 Lower end plate 52 Spring 52a Spring slope 53 Rod 54 Boss 55 Lever lower 56 Lever return 57 1st recess 58 2nd recess 59 Flat portion 60 Solution 61 Conduit 70 Connection adapter 71a Vial side holding part 71b Ejector side holding part 72 Needle part 73 Penetration hole 77 Drug powder 80 Vial 81 Drug solution 82 Cap 90 Syringe 91 Needle

Claims (23)

  1. 用時溶解システムであって、
     中空の内部空間を有して筒状に形成されたカプセルホルダーと、
     中空の内部空間を有して筒状に形成された溶解液ホルダーと、
    を備え、
     前記カプセルホルダーは、
     一方の端部に形成された第1の開口部と、
     前記カプセルホルダーの内部空間を仕切るように配置された第1の針部であって、該第1の針部は、該第1の針部を貫通する針孔部を有し、該第1の針部の針先端は、前記第1の開口部に向いている、前記第1の針部と、を備え、
     前記第1の針部の針先端と前記第1の開口部との間の前記カプセルホルダーの内部空間は、所定の物質を包むカプセルを収容可能なカプセル収容室を形成し、
     前記溶解液ホルダーは、
     一方の端部において内部空間を閉塞する閉塞端部と、
     前記閉塞端部の反対側の端部に形成された第2の開口部と、
     前記溶解液ホルダーの内部空間で摺動可能な第2の針部であって、該第2の針部の針先端は、前記第2の開口部に向いている、前記第2の針部と、
    を備え、該第2の針部の底面と前記閉塞端部との間の内部空間は、溶解液を入れるための溶解液室を形成し、
     前記第2の針部は、前記溶解液が前記溶解液室から出るための溶解液通路を備え、
     前記カプセルホルダーと前記溶解液ホルダーとは、前記第1の針部の針先端及び前記第2の針部の針先端とが対向した状態で互いに対して摺動可能に嵌合されており、前記第1の針部の針先端及び前記第2の針部の針先端との間に前記カプセルを配置することが可能である、用時溶解システム。
    Dissolving system when using
    A cylindrical capsule holder having a hollow internal space;
    A cylindrically formed solution holder having a hollow internal space;
    Equipped with
    The capsule holder is
    A first opening formed at one end,
    A first needle portion arranged to partition an internal space of the capsule holder, the first needle portion having a needle hole portion penetrating the first needle portion, the first needle portion The needle tip of the needle portion comprises the first needle portion facing the first opening;
    The internal space of the capsule holder between the needle tip of the first needle portion and the first opening forms a capsule accommodating chamber capable of accommodating a capsule that encloses a predetermined substance,
    The solution holder is
    A closed end that closes the internal space at one end;
    A second opening formed at the end opposite the closed end;
    A second needle portion slidable in an inner space of the solution holder, wherein a needle tip of the second needle portion faces the second opening; ,
    The inner space between the bottom of the second needle and the closed end forms a solution chamber for containing a solution,
    The second needle portion includes a solution passage for the solution to exit from the solution chamber,
    The capsule holder and the solution holder are slidably fitted to each other in a state where the needle tip of the first needle portion and the needle tip of the second needle portion are opposed to each other. Use dissolution system, wherein it is possible to place the capsule between the needle tip of the first needle part and the needle tip of the second needle part.
  2.  前記カプセルは、初期状態で、前記第1の針部の針先端及び前記第2の針部の針先端により接触された状態で前記カプセル収容室に配置され、前記初期状態で、前記溶解液室は密封されており、
     前記初期状態から、前記溶解液ホルダーを前記カプセルホルダーに対して押し込んだとき、互いにより接近した前記第1の針部及び前記第2の針部が前記カプセルの外皮を突き破って該カプセルを開封し、前記所定の物質を前記カプセル収容室内で解放し、さらに前記溶解液室の密封が解除され、これによって前記溶解液が前記溶解液室から前記溶解液通路を通って前記カプセル収容室へと押し出され、該溶解液により、解放された前記所定の物質が溶解されて溶液が生成される、請求項1に記載の用時溶解システム。
    The capsule is disposed in the capsule storage chamber in a state of being in contact with the tip end of the first needle portion and the tip end of the second needle portion in the initial state, and in the initial state, the solution chamber Is sealed and
    From the initial state, when the solution holder is pushed into the capsule holder, the first and second needle portions closer to each other pierce the shell of the capsule and unseal the capsule. And releasing the predetermined substance in the capsule storage chamber, and the sealing of the solution chamber is released, thereby pushing the solution from the solution chamber through the solution passage into the capsule chamber. The in-use dissolution system according to claim 1, wherein the solution dissolves the released predetermined substance to generate a solution.
  3.  前記溶解液ホルダーの内壁には、前記第2の針部を摺動可能に保持するため内周囲に亘って延在する、少なくとも1つの環状リッジが形成されている、請求項2に記載の用時溶解システム。 The inner wall of the solution holder is formed with at least one annular ridge extending over the inner periphery for slidably holding the second needle portion. When the dissolution system.
  4.  前記第2の針部の側壁には、外周囲に亘って延在するシール部が設けられ、該シール部は、前記初期状態において、前記閉塞端部に近い上側から前記環状リッジと係合することにより前記溶解液室を密封している、請求項3に記載の用時溶解システム。 The side wall of the second needle portion is provided with a seal portion extending around the outer periphery, and in the initial state, the seal portion engages with the annular ridge from the upper side near the closed end portion The in-use dissolution system according to claim 3, wherein the solution chamber is sealed thereby.
  5.  前記第2の針部には、前記シール部よりも前記針先端に近い位置から該針先端に向かって溶解液を流すための少なくとも1つの液流通用通路が形成されている、請求項4に記載の用時溶解システム。 5. The second needle portion according to claim 4, wherein at least one fluid passage for flowing the solution toward the tip of the needle from a position closer to the tip of the needle than the seal portion is formed. In-use dissolution system as described.
  6.  前記第2の針部が前記カプセルを穿刺する際に該第2の針部が抵抗を受け、押し込まれて移動する前記溶解液ホルダーに対して相対的に前記閉塞端部に近い上側に移動し、これによって前記溶解液室の密封が解除され、溶解液が前記液流通用通路を通って前記カプセル収容室へと流れる、請求項5に記載の用時溶解システム。 When the second needle portion punctures the capsule, the second needle portion receives resistance, and moves upward relatively close to the closed end with respect to the solution holder which is pushed and moved. The system according to claim 5, wherein the solution chamber is unsealed and the solution flows through the solution passage to the capsule chamber.
  7.  前記カプセルホルダーは、前記第2の開口部から前記溶解液ホルダー内へと挿入されている、請求項2乃至6のいずれか1項に記載の用時溶解システム。 The in-use dissolution system according to any one of claims 2 to 6, wherein the capsule holder is inserted into the solution holder from the second opening.
  8.  前記カプセルホルダーには、前記第1の開口部の付近の外周囲に亘ってシール部が設けられている、請求項7に記載の用時溶解システム。 The use dissolution system according to claim 7, wherein the capsule holder is provided with a seal part around the outer periphery in the vicinity of the first opening.
  9.  前記溶解液ホルダーの内壁に段差が形成されており、
     前記カプセルホルダーを前記溶解液ホルダー内に挿入するとき、前記シール部が前記段差と係合することにより前記カプセルホルダー及び前記溶解液ホルダーが一旦係止されて前記初期状態となり、該初期状態から所定以上の力で前記溶解液ホルダーを前記カプセルホルダーに対して押し込むことによって前記シール部が前記段差を乗り越え、より接近した前記第1の針部の針先端及び前記第2の針部の針先端によって前記カプセルが開封される、請求項8に記載の用時溶解システム。
    A step is formed on the inner wall of the solution holder,
    When the capsule holder is inserted into the solution holder, the capsule holder and the solution holder are temporarily locked by engaging the seal portion with the step, and the initial state is established, and the predetermined state is set from the initial state By pressing the solution holder against the capsule holder by the above force, the seal portion gets over the step by the needle tip of the first needle portion and the needle tip of the second needle portion which are closer to each other. 10. The use dissolution system according to claim 8, wherein the capsule is opened.
  10.  前記カプセルホルダーは、前記溶解液ホルダーの前記第2の開口部から挿入可能な径を有する小径部と、前記第2の開口部よりも大きい径を有する大径部と、を備え、前記第2の開口部の周囲の前記溶解液ホルダーの縁部が前記大径部と係合することによって、前記溶解液ホルダーの前記カプセルホルダーへのさらなる押し込みが係止される、請求項7乃至9のいずれか1項に記載の用時溶解システム。 The capsule holder includes a small diameter portion having a diameter insertable from the second opening of the solution holder, and a large diameter portion having a diameter larger than the second opening, 10. A further push of the solution holder into the capsule holder is locked by the engagement of the edge of the solution holder around the opening of the solution with the large diameter part. The in-use dissolution system as described in 1 or 2.
  11.  前記カプセル収容室を画定する前記カプセルホルダーの内壁には、前記カプセルを保持するため、該内壁から径方向内側に突出すると共に軸方向に沿って延びる複数のリッジが形成されている、請求項1乃至10のいずれか1項に記載の用時溶解システム。 The inner wall of the capsule holder defining the capsule accommodating chamber is formed with a plurality of ridges projecting radially inward from the inner wall and extending along the axial direction in order to hold the capsule. A use and dissolving system according to any one of the preceding claims.
  12.  前記カプセルホルダーの前記第1の開口部が形成された前記カプセルホルダーの端部とは反対側の端部の外周囲には、指掛用フランジが設けられている、請求項1乃至11のいずれか1項に記載の用時溶解システム。 The finger hook flange is provided on the outer periphery of the end opposite to the end of the capsule holder where the first opening of the capsule holder is formed. The in-use dissolution system as described in 1 or 2.
  13.  前記カプセルホルダーの前記第1の開口部が形成された前記カプセルホルダーの端部とは反対側の端部には、前記カプセル収容室内の溶液を前記針孔部を通して吸引する噴出器が係合されている、請求項1乃至12のいずれか1項に記載の用時溶解システム。 At the end opposite to the end of the capsule holder where the first opening of the capsule holder is formed, a sprayer for drawing the solution in the capsule storage chamber through the needle hole is engaged 13. A use dissolution system according to any one of the preceding claims.
  14.  前記カプセルホルダーの前記反対側の端部には、第3の開口部が形成されており、
     前記第3の開口部から前記第1の針部の底面までの前記カプセルホルダーの内部空間は、前記噴出器の少なくとも一部が脱着可能に係合される噴出器室を形成している、請求項13に記載の用時溶解システム。
    A third opening is formed at the opposite end of the capsule holder,
    The internal space of the capsule holder from the third opening to the bottom surface of the first needle portion forms a jet chamber in which at least a portion of the jet is detachably engaged. The in-use dissolution system according to Item 13.
  15.  前記噴出器は、
     前記噴出器室内に脱着可能に係合される先端部であって、該先端部は、前記噴出器室内に係合されたとき前記針孔部と整合する先端孔を有する、前記先端部と、
     前記先端部から後方に延在するスパウトであって、該スパウトの内部空間は、前記先端孔と連通している、前記スパウトと、
     前記スパウトの内部空間内を軸方向に摺動可能に構成されたピストンと、
     前記ピストンから軸方向に延在するプランジャ部と、
    を備え、
     前記プランジャ部を、前記スパウトから離れるように引くことによって前記ピストンが前記先端部から離れるように移動し、これによって前記先端孔を通って前記溶解液が前記スパウトの内部空間に流入し、
     前記プランジャ部を、前記スパウトに近づけるように押すことによって前記ピストンが前記先端部に接近するように移動し、これによって前記スパウト内の溶液が前記先端孔を通って噴出する、請求項14に記載の用時溶解システム。
    The sprayer is
    A tip that is removably engaged within the chamber, the tip having a tip bore that aligns with the needle bore when engaged into the chamber;
    A spout extending rearward from the tip, the internal space of the spout communicating with the tip hole;
    A piston axially slidable in the interior space of the spout;
    A plunger portion extending axially from the piston;
    Equipped with
    The piston is moved away from the tip by pulling the plunger away from the spout, whereby the solution flows into the internal space of the spout through the tip hole,
    15. The apparatus according to claim 14, wherein the piston is moved closer to the tip by pushing the plunger portion closer to the spout, whereby the solution in the spout spouts through the tip hole. In-use dissolution system.
  16.  前記プランジャ部は、
     前記ピストンから軸方向に下方に延在するピストンロッドと、
     前記ピストンロッドと並んで前記ピストンから下方に延在するレバーと、
     前記ピストンロッド及び前記レバーの下方に配置された下端プレートと、
     前記下端プレートから上方に前記レバーと係合可能に延在するボスと、
     前記下端プレートと前記ピストンロッドの下端との間に設けられたバネであって、該バネは、縮むときに拡径する、前記バネと、
    を備え、
     前記レバーは、前記ピストンロッドと並んだ位置から径方向に変位するように撓むことが可能であり、
     前記レバーは、
     前記レバーの下端に設けられ、拡径した前記バネと係合可能なレバー下部と、
     前記レバー下部よりも上方に形成され、径方向外側の前記ボスの側に突出するレバー返しと、
     前記レバー下部と前記レバー返しとの間に形成された第1の凹部と、
     前記レバー返しの上方に隣接して形成された第2の凹部と、
     前記第2の凹部の上方に形成された平坦部と、
     前記平坦部よりも上方の前記レバーの所定の位置で径方向外側に突出するストッパーと、
    を備える、請求項15に記載の用時溶解システム。
    The plunger portion is
    A piston rod extending axially downward from the piston;
    A lever extending downwardly from the piston in line with the piston rod;
    A lower end plate disposed below the piston rod and the lever;
    A boss extending upwardly from the lower end plate and engageable with the lever;
    A spring provided between the lower end plate and the lower end of the piston rod, the spring expanding in diameter when contracted;
    Equipped with
    The lever can be flexed to displace radially from a position aligned with the piston rod,
    The lever is
    A lower part of the lever which is provided at the lower end of the lever and which can engage with the expanded spring;
    A lever return that is formed above the lower portion of the lever and protrudes to the side of the boss on the radially outer side;
    A first recess formed between the lower portion of the lever and the lever barb;
    A second recess formed adjacent to the upper side of the lever;
    A flat portion formed above the second recess;
    A stopper projecting radially outward at a predetermined position of the lever above the flat portion;
    20. The on-use dissolution system according to claim 15, comprising
  17.  前記下端プレートが押されずに前記バネが付勢されていない初期状態では、前記ボスは前記第1の凹部内に収まっており、
     前記下端プレートが押されたとき、前記バネが縮んで前記レバー下部と係合し、
     前記下端プレートが押されている間に、前記ボスは前記下端プレートと共に上方に移動し、これによって前記ボスが前記レバー返しを乗り越え、
     前記ボスが前記レバー返しを乗り越えた後も前記下端プレートが押されるとき、前記バネはさらに縮んだ状態となり、この状態において前記バネと前記レバー下部との係合により前記レバー及び前記ストッパーは前記ボスに対抗して前記初期状態よりも径方向外側に位置すると共に前記ボスが前記レバーの前記平坦部に係合し、
     前記バネが前記さらに縮んだ状態で前記下端プレートが押されるとき、前記ピストンロッド及び前記ピストンが、径方向外側に移動した前記ストッパーが前記スパウトと係合するまで上方に移動し、これによって前記スパウトの内部空間に充填されていた溶液のうち第1の所定量の溶液が前記先端部から噴出され、
     前記下端プレートが押されなくなることによって、前記バネが前記レバー下部を押す力が減少するため前記ボスが前記レバーをより径方向内側へと押しながら戻り、前記さらに縮んだ状態のバネは、前記ボスが前記第2の凹部に入り込みかつ前記レバー返しで係止されるまで伸び、前記ボスが前記レバー及び前記ストッパーをより径方向内側に移動させたことによって前記ストッパーが解除され、
     前記ストッパーが解除された後、前記下端プレートが再度押されると、前記ピストンロッド及び前記ピストンが上方に移動し、前記スパウト内に残っていた第2の所定量の溶液が前記先端部から噴出される、請求項16に記載の用時溶解システム。
    In an initial state in which the lower end plate is not pressed and the spring is not biased, the boss is accommodated in the first recess,
    When the lower end plate is pushed, the spring contracts and engages with the lower portion of the lever,
    While the lower end plate is being pushed, the boss moves upward with the lower end plate, whereby the boss gets over the lever return and
    When the lower end plate is pushed even after the boss passes over the lever, the spring is further contracted, and in this state, the lever and the stopper are the boss due to the engagement between the spring and the lower portion of the lever. And the boss is engaged with the flat portion of the lever while being positioned radially outward of the initial state.
    When the lower end plate is pushed in the state where the spring is further contracted, the piston rod and the piston move upward until the stopper moved radially outward engages with the spout, thereby the spout A first predetermined amount of solution of the solution filled in the inner space of the
    When the lower end plate is not pushed, the force by which the spring pushes the lower part of the lever decreases, and the boss returns while pushing the lever more radially inward, and the spring in the further contracted state is the boss Extends into the second recess and is locked by the lever, and the boss is released by moving the lever and the stopper inward in the radial direction, thereby releasing the stopper.
    After the stopper is released, when the lower end plate is pressed again, the piston rod and the piston move upward, and a second predetermined amount of solution remaining in the spout is ejected from the tip end. 17. The use-in-use dissolution system according to claim 16.
  18.  前記バネは、縮んだとき軸方向に対する角度が増大して径方向の長さを増大させる傾斜部を有する、請求項16又は17に記載の用時溶解システム。 18. The use-time dissolution system according to claim 16 or 17, wherein the spring has an inclined portion which when contracted reduces the angle with respect to the axial direction to increase the radial length.
  19.  前記ボスは、円柱状の先端部と、該円柱状の先端部を支持するため前記下端プレートから該先端部まで延在するロッドと、を備えている、請求項16乃至18のいずれか1項に記載の用時溶解システム。 19. The boss according to any of claims 16-18, wherein the boss comprises a cylindrical tip and a rod extending from the lower end plate to the tip for supporting the cylindrical tip. In-use dissolution system as described in.
  20.  少なくとも前記スパウト及び前記ピストンロッドの一部を覆うハウジングを備える、請求項16乃至19のいずれか1項に記載の用時溶解システム。 20. The use-time dissolution system according to any one of claims 16-19, comprising a housing covering at least the spout and a part of the piston rod.
  21.  前記ピストンロッドは、該ピストンロッドの外側表面から径方向外側に突出する第1の係止突起を備え、
     前記ハウジングは、該ハウジングの内壁から径方向内側に突出する第2の係止突起を備え、
     前記第1の係止突起及び前記第2の係止突起が係合することによって前記ピストンの下死点が画定される、請求項20に記載の用時溶解システム。
    The piston rod includes a first locking projection projecting radially outward from the outer surface of the piston rod,
    The housing comprises a second locking projection projecting radially inward from the inner wall of the housing,
    21. The use-time dissolution system according to claim 20, wherein the bottom dead center of the piston is defined by the engagement of the first locking projection and the second locking projection.
  22.  前記ハウジングは、径方向外側に突出する指掛用フランジを備える、請求項20又は21に記載の用時溶解システム。 22. The use-time dissolution system according to claim 20 or 21, wherein the housing comprises a radially outwardly projecting finger flange.
  23.  前記所定の物質は、固体粉末状の薬剤である、請求項1乃至22のいずれか1項に記載の用時溶解システム。 23. The use-dissolution system according to any one of the preceding claims, wherein the predetermined substance is a solid powder drug.
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