WO2019004128A1 - Système de dissolution au moment de l'utilisation - Google Patents

Système de dissolution au moment de l'utilisation Download PDF

Info

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
Authority
WO
WIPO (PCT)
Prior art keywords
solution
needle
capsule
holder
lever
Prior art date
Application number
PCT/JP2018/024012
Other languages
English (en)
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 JP2019526889A priority Critical patent/JP7197173B2/ja
Priority to CN201880043090.9A priority patent/CN110913824B/zh
Publication of WO2019004128A1 publication Critical patent/WO2019004128A1/fr

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J3/00—Devices 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un système de dissolution au moment de l'utilisation permettant de dissoudre une substance prédéterminée dans une capsule à l'aide d'un liquide de dissolution au moment de l'utilisation. Le système de dissolution au moment de l'utilisation (1) est pourvu d'un support de capsule (3) et d'un support de liquide de dissolution (4). Le support de capsule (3) est pourvu d'une première partie d'ouverture et d'une première partie d'aiguille, et forme un compartiment de stockage de capsule dans lequel une capsule (6) peut être stockée. Le support de liquide de dissolution (4) est pourvu d'une partie d'extrémité fermée, d'une seconde partie d'ouverture, et d'une seconde partie d'aiguille qui peut coulisser dans un espace interne et comprend un passage de liquide de dissolution, le support de liquide de dissolution (4) formant un compartiment de liquide de dissolution. Le support de capsule (3) et le support de liquide de dissolution (4) sont appariés en coulissement l'un à l'autre dans un état dans lequel les pointes d'aiguille des première et seconde parties d'aiguille sont opposées l'une à l'autre, la capsule (6) étant disposée entre les pointes d'aiguille. Un pulvérisateur (2) pourvu d'un mécanisme de double extrusion est apparié au support de capsule (3). Le mécanisme est pourvu d'un levier parallèle à une tige de piston, d'un ressort entre une plaque d'extrémité inférieure et la tige de piston, et d'un bossage, le levier étant pourvu d'un bouchon qui est verrouillé sur un bec verseur par la première extrusion, d'une partie inférieure de levier pouvant venir en prise avec le bossage, d'un retour de levier et d'une partie évidée.
PCT/JP2018/024012 2017-06-26 2018-06-25 Système de dissolution au moment de l'utilisation WO2019004128A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2019526889A JP7197173B2 (ja) 2017-06-26 2018-06-25 用時溶解システム
CN201880043090.9A CN110913824B (zh) 2017-06-26 2018-06-25 使用时溶解系统

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2017-124682 2017-06-26
JP2017124682 2017-06-26

Publications (1)

Publication Number Publication Date
WO2019004128A1 true WO2019004128A1 (fr) 2019-01-03

Family

ID=64741577

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2018/024012 WO2019004128A1 (fr) 2017-06-26 2018-06-25 Système de dissolution au moment de l'utilisation

Country Status (3)

Country Link
JP (1) JP7197173B2 (fr)
CN (1) CN110913824B (fr)
WO (1) WO2019004128A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021090876A1 (fr) * 2019-11-06 2021-05-14 ニプロ株式会社 Dispositif d'éjection de type seringue

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59120166A (ja) * 1982-12-20 1984-07-11 メデイテツク・エス・ア−・ 予備充填式アンプル注射器
JPH10502829A (ja) * 1992-08-13 1998-03-17 サイエンス インコーポレイテッド 混合放出注射器アセンブリ
JP2001522717A (ja) * 1997-11-08 2001-11-20 インジ エリッヒ プファイファ ゲーエムベーハ 少なくとも２つの異なった媒体の塗布方法並びにそのためのディスペンサ
JP2004500201A (ja) * 2000-02-23 2004-01-08 アボット・ラボラトリーズ 制御された量の治療物質を選択的に供与するためのシリンジおよびシリンジシステム
JP2006526475A (ja) * 2003-06-02 2006-11-24 ベクトン・ディキンソン・アンド・カンパニー カートリッジ付きの医薬マイクロデバイス給送システム
JP2010284389A (ja) * 2009-06-15 2010-12-24 Koichi Saito 薬剤懸濁液化具と薬剤懸濁液化方法
JP2013000489A (ja) * 2011-06-21 2013-01-07 Shinko Chemical Co Ltd 噴霧容器
JP2013230208A (ja) * 2012-04-27 2013-11-14 Yoshino Kogyosho Co Ltd 定量シリンジ型噴出器

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19615422A1 (de) * 1996-04-19 1997-11-20 Boehringer Ingelheim Kg Zweikammer-Kartusche für treibgasfreie Dosieraerosole
JP4150389B2 (ja) * 2005-09-05 2008-09-17 日本ケミカルリサーチ株式会社 注射装置
US20080015539A1 (en) * 2006-02-28 2008-01-17 Robert Pieroni Bottle with adapter for receiving needleless syringe
IL186290A0 (en) * 2007-09-25 2008-01-20 Medimop Medical Projects Ltd Liquid drug delivery devices for use with syringe having widened distal tip
US8857470B2 (en) * 2011-01-25 2014-10-14 Fresenius Kabi Deutschland Gmbh Connection device for connecting a first reservoir with a second reservoir

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS59120166A (ja) * 1982-12-20 1984-07-11 メデイテツク・エス・ア−・ 予備充填式アンプル注射器
JPH10502829A (ja) * 1992-08-13 1998-03-17 サイエンス インコーポレイテッド 混合放出注射器アセンブリ
JP2001522717A (ja) * 1997-11-08 2001-11-20 インジ エリッヒ プファイファ ゲーエムベーハ 少なくとも２つの異なった媒体の塗布方法並びにそのためのディスペンサ
JP2004500201A (ja) * 2000-02-23 2004-01-08 アボット・ラボラトリーズ 制御された量の治療物質を選択的に供与するためのシリンジおよびシリンジシステム
JP2006526475A (ja) * 2003-06-02 2006-11-24 ベクトン・ディキンソン・アンド・カンパニー カートリッジ付きの医薬マイクロデバイス給送システム
JP2010284389A (ja) * 2009-06-15 2010-12-24 Koichi Saito 薬剤懸濁液化具と薬剤懸濁液化方法
JP2013000489A (ja) * 2011-06-21 2013-01-07 Shinko Chemical Co Ltd 噴霧容器
JP2013230208A (ja) * 2012-04-27 2013-11-14 Yoshino Kogyosho Co Ltd 定量シリンジ型噴出器

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021090876A1 (fr) * 2019-11-06 2021-05-14 ニプロ株式会社 Dispositif d'éjection de type seringue
JP2021074072A (ja) * 2019-11-06 2021-05-20 ニプロ株式会社 シリンジ型噴出装置
JP7371445B2 (ja) 2019-11-06 2023-10-31 ニプロ株式会社 シリンジ型噴出装置
EP4052746A4 (fr) * 2019-11-06 2023-11-22 Nipro Corporation Dispositif d'éjection de type seringue

Also Published As

Publication number Publication date
CN110913824B (zh) 2022-04-19
JP7197173B2 (ja) 2022-12-27
CN110913824A (zh) 2020-03-24
JPWO2019004128A1 (ja) 2020-06-11

Similar Documents

Publication Publication Date Title
US8523807B2 (en) Airless mixing with a by-pass syringe
JP5788399B2 (ja) インターバイアル移送システム
JP4785831B2 (ja) シリンジ装置及び該装置を用いた液剤の調製方法
JP2014506494A (ja) 第１のリザーバーを第２のリザーバーに接続する接続装置
KR20090103914A (ko) 에어졸 분사기의 트리거식 헤드 캡
US6669061B2 (en) Pump dispenser and spraying apparatus
MXPA03007940A (es) Inyector de frasco de seguridad pre-relleno.
JP6271549B2 (ja) 再構成装置
JP2010528789A (ja) カートリッジから容器に液体を移送する装置
KR102652130B1 (ko) 격막을 갖는 플라스크용 천자 바늘
EP2939700B1 (fr) Récipient à jet du type seringue
WO2019004128A1 (fr) Système de dissolution au moment de l'utilisation
US20120330280A1 (en) Airless mixing with a by-pass syringe
CN108135777B (zh) 用于连通两种物质的注射器装置及其方法
JP5959269B2 (ja) 噴霧容器
JP6391082B2 (ja) 混合噴出器
JP5968167B2 (ja) 混合噴出器
JP2013000489A (ja) 噴霧容器
JP2009057084A (ja) 液体噴出器
JP2017530804A (ja) 注射を準備するためのシステムおよび方法
JP5992266B2 (ja) シリンジ型噴出器用の噴出量調整具及び、それを備えるシリンジ型噴出器
CN104640533B (zh) 带有头帽的重构装置
JP2013031483A (ja) カートリッジ式注射器
JP5434084B2 (ja) コネクタ
JPH1176879A (ja) 押ボタンの上端部を中心に旋回し得る旋回噴射構造体

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 18823802

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2019526889

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 18823802

Country of ref document: EP

Kind code of ref document: A1