CN110913824B

CN110913824B - Dissolving system during use

Info

Publication number: CN110913824B
Application number: CN201880043090.9A
Authority: CN
Inventors: 西东勋; 徳田淳也; 山田秀树
Original assignee: Shinko Chemical Co Ltd
Current assignee: Shinko Chemical Co Ltd
Priority date: 2017-06-26
Filing date: 2018-06-25
Publication date: 2022-04-19
Anticipated expiration: 2038-06-25
Also published as: WO2019004128A1; JPWO2019004128A1; JP7197173B2; CN110913824A

Abstract

The invention provides a dissolving system for dissolving a predetermined substance in a capsule in a dissolving liquid. The dissolution system (1) comprises a capsule holder (3) and a dissolution solution holder (4) when in use. The capsule holder (3) is provided with a 1 st opening and a 1 st needle, and forms a capsule housing chamber capable of housing a capsule (6). The solution holder (4) has a closed end, a 2 nd opening, and a 2 nd needle part which is slidable in the inner space and has a solution passage, and forms a solution chamber. The capsule holder (3) and the solution holder (4) are slidably fitted to each other in a state where the needle tips of the 1 st and 2 nd needle parts face each other, and the capsule (6) is disposed between the needle tips. A ejector (2) having a double extrusion mechanism is fitted to a capsule holder (3). The mechanism comprises a piston rod, control rods arranged in parallel, a spring between the piston rods of the lower end plate, and a protrusion, wherein the control rods are provided with stoppers locked with the outflow grooves through primary extrusion, control rod lower parts capable of being clamped with the protrusion, control rod folding parts and concave parts.

Description

Dissolving system during use

Technical Field

The present invention relates to an in-use dissolution system for dissolving a predetermined substance in a dissolution liquid at the time of use.

Background

It is generally recognized that the drug becomes unstable due to hydrolysis in a solution state. Therefore, in a region where the storage state of the drug is incomplete and the temperature is high, it is preferable to store the drug in a solid state for the stability of the drug. Further, it is considered that the stability can be further improved by enclosing the drug in a solid state (or in a state in which it does not enter a fluid state of moisture) in a capsule packaged by PTP or the like. Therefore, it is desired to develop a system for dissolving a solid drug stored in a capsule.

As a system for ejecting a medicine, a quantitative syringe type ejector described in patent document 1 is known. However, this medicine dispenser only relates to a technique in which a nasal drop in a dissolved state is filled in advance in a quantitative syringe, and the nasal drop can be finely divided and sprayed by pushing in a plunger. Therefore, patent document 1 does not disclose a system for dissolving a solid drug stored in a capsule.

Patent document 1: japanese patent laid-open publication No. 2013-230208

Disclosure of Invention

The present invention has been made in view of the above circumstances, and an object thereof is to provide an in-use dissolution system capable of dissolving a predetermined substance stored in a capsule in a dissolution liquid in use, and an in-use dissolution system combined with a sprayer for spraying a solution in which the predetermined substance is dissolved.

In order to solve the above problem, a dissolution system for use according to the present invention includes: a capsule holder having a hollow inner space and formed in a cylindrical shape; and a solution holder having a hollow inner space and formed in a cylindrical shape, the capsule holder including: a 1 st opening formed at one end; and a 1 st needle portion disposed to partition an internal space of the capsule holder, the 1 st needle portion having a needle hole portion penetrating the 1 st needle portion, a needle tip of the 1 st needle portion facing the 1 st opening, the internal space of the capsule holder between the needle tip of the 1 st needle portion and the 1 st opening forming a capsule accommodating chamber capable of accommodating a capsule in which a predetermined substance is encapsulated, the dissolution liquid holder comprising: a closed end portion at one end portion closing the inner space; a 2 nd opening formed at an end opposite to the closed end; and a 2 nd needle part slidable in the internal space of the solution holder, a needle tip of the 2 nd needle part facing the 2 nd opening, an internal space between a bottom surface of the 2 nd needle part and the closed end part forming a solution chamber for receiving a solution, the 2 nd needle part including a solution passage for allowing the solution to flow out of the solution chamber, the capsule holder and the solution holder being slidably fitted to each other in a state where the needle tip of the 1 st needle part and the needle tip of the 2 nd needle part are opposed to each other, and the capsule being capable of being disposed between the needle tip of the 1 st needle part and the needle tip of the 2 nd needle part.

According to the present invention, the capsule is arranged in the capsule housing chamber in an initial state in which the capsule is in contact with the needle tip end of the 1 st needle part and the needle tip end of the 2 nd needle part, and the dissolution liquid chamber is sealed, and after the dissolution liquid holder is pressed against the capsule holder from the initial state, the 1 st needle part and the 2 nd needle part which are further close to each other pierce the outer skin of the capsule and unseal the capsule, thereby releasing the predetermined substance in the capsule housing chamber, and the sealing of the dissolution liquid chamber is released, whereby the dissolution liquid is pushed out from the dissolution liquid chamber to the capsule housing chamber through the dissolution liquid passage, and the released predetermined substance is dissolved by the dissolution liquid to produce a solution.

As the structure for sealing and unsealing the dissolution liquid chamber, it is preferable that: at least one annular ridge extending around the inner periphery is formed on the inner wall of the solution holder to slidably hold the 2 nd needle portion. In addition, a sealing portion extending around the outer periphery is provided on the side wall of the 2 nd needle portion, and the sealing portion engages with the annular ridge from an upper side closer to the closed end in the initial state, thereby sealing the dissolution liquid chamber. At least one liquid passage for allowing the solution to flow from a position closer to the needle tip than the seal portion toward the needle tip is formed in the 2 nd needle portion. In the above-described configuration, when the 2 nd needle portion pierces the capsule, the 2 nd needle portion receives resistance and moves relatively to the solution holder, which is pushed and moved, toward the upper side closer to the closed end portion, thereby releasing the seal of the solution chamber, and the solution flows into the capsule accommodating chamber through the liquid passage.

As a form of fitting the capsule holder and the solution holder, for example, the capsule holder is inserted into the solution holder from the 2 nd opening. In this case, it is preferable that: the capsule holder is provided with a seal portion around the outer periphery of the capsule holder in the vicinity of the 1 st opening. More preferably: a step is formed on an inner wall of the solution holder, and when the capsule holder is inserted into the solution holder, the capsule holder is temporarily engaged with the solution holder by engaging the sealing portion with the step to bring the capsule holder into the initial state, and the solution holder is pressed against the capsule holder with a predetermined force or more from the initial state, whereby the sealing portion goes over the step, and the capsule is opened by the needle tip of the 1 st needle portion and the needle tip of the 2 nd needle portion which are further close to each other. Further, the capsule holder may include: a small diameter portion having a diameter that can be inserted from the 2 nd opening of the solution holder; and a large diameter portion having a diameter larger than the 2 nd opening, wherein the edge portion of the solution holder around the 2 nd opening is engaged with the large diameter portion, thereby further press-fitting and locking the solution holder to the capsule holder.

Preferably: the capsule holder has an inner wall defining the capsule accommodating chamber, and a plurality of ridges projecting radially inward from the inner wall and extending in an axial direction to hold the capsule. Further, a finger-hooking flange is provided around the outer periphery of an end portion of the capsule holder opposite to the end portion of the capsule holder where the 1 st opening is formed.

The dissolution system in use according to the present invention may be combined with the ejector in the dissolution system in use according to each of the above embodiments. In the dissolution system for use, an ejector that sucks the solution in the capsule housing chamber through the needle hole portion is engaged with an end portion of the capsule holder on the opposite side of the end portion of the capsule holder where the 1 st opening is formed. Further, a 3 rd opening is formed at the opposite end of the capsule holder, and an ejector chamber in which at least a part of the ejector is detachably engaged is formed in an inner space of the capsule holder from the 3 rd opening to the bottom surface of the 1 st needle portion.

The ejector includes: a tip section detachably engaged with the ejector chamber, the tip section having a tip hole that matches the pinhole section after being engaged with the ejector chamber; a spout extending rearward from the tip portion, an inner space of the spout communicating with the tip hole; a piston configured to be slidable in an axial direction in an inner space of the spout; and a plunger portion extending in an axial direction from the piston, wherein the plunger portion is moved so as to be apart from the tip portion by pulling the plunger portion so as to be apart from the spout, whereby the solution flows into an inner space of the spout through the tip hole, and wherein the plunger portion is moved so as to be close to the spout by pressing the plunger portion so as to be close to the spout, whereby the solution in the spout is discharged through the tip hole.

The ejector of a preferred embodiment of the present invention includes a double extrusion mechanism. The plunger portion of the ejector including the two-stage extrusion mechanism includes: a piston rod extending downward in the axial direction from the piston; a control rod which is arranged in parallel with the piston rod and extends downward from the piston; a lower end plate disposed below the piston rod and the control rod; a protrusion 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 a lower end of the piston rod, the spring expanding in diameter when contracted, the control rod being capable of flexing to displace in a radial direction from a position in parallel with the piston rod, the control rod including: a lower part of the control rod, which is arranged at the lower end of the control rod and can be clamped with the expanded spring; a lever folding portion formed above the lower portion of the lever and protruding to one side of the projection radially outward; a 1 st recess formed between the lower portion of the control lever and the control lever folded portion; a 2 nd recess formed adjacent to an upper side of the lever folded portion; a flat portion formed above the 2 nd recess; and a stopper protruding radially outward at a predetermined position of the control lever above the flat portion.

According to the ejector including the double extrusion mechanism of the present invention, in an initial state where the spring is not urged by pressing the lower end plate, the projection is housed in the 1 st recessed portion, the spring is contracted and engaged with the lower portion of the control rod after pressing the lower end plate, the projection is moved upward together with the lower end plate while pressing the lower end plate, whereby the projection passes over the control rod folded portion, and when the lower end plate is pressed also after the projection passes over the control rod folded portion, the spring is brought into a further contracted state in which the control rod and the stopper are positioned radially outward of the initial state against the projection by engagement of the spring with the lower portion of the control rod, and the projection is engaged with the flat portion of the control rod, when the spring is further contracted, the piston rod and the piston move upward until the stopper moved radially outward engages with the spout, whereby a 1 st predetermined amount of the solution in the solution filled in the internal space of the spout is discharged from the tip, and the force of the spring pressing the lower portion of the control lever is reduced by not pressing the lower end plate, so that the control lever is pressed radially inward by the projection and returned, the spring in the further contracted state expands until the projection enters the 2 nd recessed portion and is locked by the control lever folding portion, the control lever and the stopper are moved radially inward by the projection, and the stopper is released, and when the lower end plate is pressed again after the stopper is released, the piston rod and the piston move upward to eject a 2 nd predetermined amount of the solution remaining in the spout from the tip portion.

For example, the following may be configured: the spring has an inclined portion which increases the angle with respect to the axial direction after contraction and increases the length in the radial direction. Further, the following may be configured: the projection includes a cylindrical tip portion and a rod extending from the lower end plate to the tip portion for supporting the cylindrical tip portion. Further, the piston rod may include a housing that covers at least a part of the piston rod and the spout. Preferably: the piston rod includes a 1 st locking protrusion protruding radially outward from an outer surface of the piston rod, the housing includes a 2 nd locking protrusion protruding radially inward from an inner wall of the housing, and the 1 st locking protrusion engages with the 2 nd locking protrusion to define a bottom dead center of the piston. In order to improve the operability, the configuration may be such that: the housing includes a finger-hooking flange projecting radially outward.

The predetermined substance can be any substance that can produce a solution that can achieve a predetermined purpose by being sealed in a capsule and dissolved in a dissolving solution. Preferably, the prescribed substance is a solid powdered medicament.

Drawings

Fig. 1 is a longitudinal sectional view (partially excluding) of a dissolution system in use in combination with a sprayer according to an embodiment of the present invention.

FIG. 2 is a longitudinal sectional view (partially excluding) of the dissolution system in use in a state where a solution is generated in the dissolution system in use of FIG. 1 and the solution is transferred to the ejector.

Fig. 3 is a diagram of a capsule holder which is one of the components of the dissolution system at the time of use according to the present embodiment, (a) is a plan view, (b) is a front view shown as a partial sectional view, and (c) is a perspective view of the 1 st needle portion.

Fig. 4 is a front view showing a partial cross-sectional view of a case of a dissolution solution holder, which is one of components of the dissolution system in use according to the present embodiment.

Fig. 5 is a view of the 2 nd needle portion attached to the housing of the solution holder in fig. 4, wherein (a) is a front view shown as a partial sectional view, (b) is a bottom view, and (c) is a perspective view.

Fig. 6 is a front view showing a partial sectional view of a solution holder completed by attaching the 2 nd needle part of fig. 5 to the housing of fig. 4.

Fig. 7 is a sectional view showing a flow path of the solution filled in the solution holder of fig. 6.

Fig. 8 is a diagram showing a dissolution system in use according to the present embodiment in which a capsule is prepared by coupling a capsule holder in which the capsule is placed and a dissolution solution holder.

FIG. 9 is a cross-sectional view showing the locking mechanism of the dissolution system in use in which the capsule of FIG. 8 is fitted.

Fig. 10 is a longitudinal sectional view of the ejector in the use dissolution system according to the present embodiment, in which the combination of the capsule holder and the dissolution solution holder is removed from the ejector.

Fig. 11 is a view showing a plunger portion of the ejector of fig. 10, in which (a) is a plan view, (b) is an upper end face view, a left side view, and a lower end face view, and (c) is a bottom view.

Fig. 12 is a view showing a part of the plunger portion of fig. 11, (a) is a sectional view taken along line a-a of fig. 11 (B), (B) is a sectional view taken along line B-B of fig. 11 (B), (C) is an enlarged detail view of a portion shown in C of fig. 11 (B), and (D) is an enlarged detail view of a portion shown in D of fig. 11 (B).

Fig. 13 is a diagram showing the operation of the ejector of fig. 11 when the ejector is extruded twice from the initial state in the order of steps (1) to (5), where (1) to (3) relate to the first extrusion operation, (4) relate to the operation after the finger is released after the locking by the first extrusion, and (5) relate to the second extrusion operation.

Fig. 14 is a diagram showing another example of use of the ejector of fig. 11.

Fig. 15 is a diagram for explaining a preparation stage of a vial in another example of use of the ejector of fig. 14.

Fig. 16 is a view of a 2 nd needle portion according to another example attached to a housing of the solution holder of fig. 4, wherein (a) is a front view shown as a partial sectional view, and (b) is a perspective view.

Detailed Description

(dissolution system when used)

A dissolution system in use according to an embodiment of the present invention will be described below with reference to the drawings.

Fig. 1 shows an in-use dissolution system 1 according to an embodiment of the present invention, which can dissolve a predetermined substance stored in a capsule in a dissolution liquid in use. The dissolution system 1 is combined with a sprayer 2 for spraying a solution generated by the dissolution system 1 during use to constitute a dissolution system 5 during use (i.e., dissolution spraying system during use).

The dissolution system 1 includes: a capsule holder 3 having a hollow inner space and formed in a cylindrical shape; and a solution holder 4 having a hollow inner space and formed in a cylindrical shape. The capsule holder 3 accommodates a capsule 6 in which a predetermined material such as a drug powder is encapsulated by PTP or the like, and the dissolution liquid holder 4 accommodates a dissolution liquid 7 in which the drug powder in the capsule 6 can be dissolved. Fig. 2 shows a state in which the dissolution system 1 has opened the capsule 6 at the time of use to dissolve the substance encapsulated in the capsule in the dissolution liquid and generate a solution, but details will be described later.

As shown in fig. 3 (a) and (b), the capsule holder 3 includes an opening 10 (1 st opening) formed at one end portion and a 1 st needle portion 11 arranged to partition an internal space of the capsule holder 3. A sealing portion 19 is provided around the outer periphery of the capsule holder in the vicinity of the opening 10. The sealing portion 19 is provided for sealing when fitted to the solution holder 4 described later.

The 1 st needle part 11 has a needle hole 17 penetrating the 1 st needle part, and the needle tip 12 of the 1 st needle part 11 faces the opening 10. Fig. 3 (c) shows an example of the 1 st pin part 11. In the example of fig. 3 (c), the 1 st needle part 11 has a shape obtained by partially cutting the side portion of the needle tip 12 out of the conical shape, and a through hole 18 is formed as a hole on the needle side of the needle hole part 17 in the cut portion of the needle tip 12. For example, in the example of fig. 3 (a) and (c), 3 through holes 18 are formed at intervals of 120 degrees. The 1 st needle part 11 may be integrally formed with the capsule holder 3.

The inner space of the capsule holder 3 between the needle tip 12 of the 1 st needle part 11 and the opening 10 forms a capsule accommodating chamber 13 capable of accommodating the capsule 6. In order to firmly hold the capsule 6 in the capsule housing chamber 13, a ridge 20 that protrudes radially inward from the inner wall of the capsule holder 3 defining the capsule housing chamber 13 and extends in the axial direction is formed on the inner wall. As shown in fig. 3 (a), the ridges 20 may be provided at 3 points every 120 degrees.

An opening 16 (the 3 rd opening) is formed at an end portion of the capsule holder 3 opposite to the opening 10, and a flange 16a is formed on the outer wall of the capsule holder in the vicinity of the opening 16. The capsule holder 3 is divided into a small diameter portion 3a which is a cylindrical portion having a small diameter and a large diameter portion 3b which is a cylindrical portion having a larger diameter. The inner space between the 1 st needle 11 and the opening 16 forms ejector chambers (14, 15) into which the tip of the ejector 2 is inserted. A ridge 21 for holding the tip end of the ejector 2 is formed in the ejector chamber 15 on the large diameter portion 3b side.

As shown in fig. 6, the solution holder 4 includes: a closed end portion 22 closing the inner space at one end portion; an opening 23 (opening 2) formed at an end opposite to the closed end 22; and a 2 nd needle part 25 which can slide in the inner space of the solution holder 4. The needle tip 27 of the 2 nd needle portion 25 faces the opening 23. In order to slidably hold the 2 nd needle portion 25 in the internal space of the solution holder 4, as shown in fig. 4, an annular ridge 24 extending over the inner periphery so as to contact the side wall of the 2 nd needle portion 25 is formed on the inner wall of the solution holder 4. In the present embodiment, two annular ridges 24 are formed in order to reliably maintain the stability of the 2 nd needle portion 25, but the present invention is not limited thereto.

As shown in fig. 5 (a) and (c), the 2 nd needle portion 25 includes a base portion 26, a needle tip 27 extending from the base portion 26, and a seal portion 29 extending over the outer periphery of the base portion 26. As shown in fig. 5 (b) and (c), a liquid flow groove 28 extending in the axial direction below the seal portion 29 is formed in the side wall of the base portion 26. The liquid flow path groove 28 may be formed in plural.

The opening 23 is sized so as to be insertable into the small diameter portion 3a of the capsule holder 3, and the sealing portion 19 of the capsule holder 3 comes into contact with the inner wall of the solution holder 4, whereby the capsule holder 3 and the solution holder 4 can be slid relative to each other while maintaining the sealing property.

Referring again to fig. 6, the inner space between the bottom surface of the 2 nd needle portion 25 and the closed end portion 22 forms a dissolution liquid chamber 30 into which a dissolution liquid is put. In addition, in the dissolution liquid chamber 30, air 31 may enter in addition to the dissolution liquid 7. In this state, the sealing portion 29 (fig. 5 (a), (c)) does not contact the inner wall of the solution holder 4, but engages with the upper annular ridge 24 (fig. 4) closer to the closed end 22, thereby sealing the solution chamber 30.

As shown in fig. 7, when the seal 29 is away from the upper annular ridge 24, the 2 nd needle portion 25 forms a solution passage for allowing the solution to flow out from the solution chamber 30 toward the tip end of the 2 nd needle portion in the C direction between the side wall of the 2 nd needle portion 25 and the inner wall of the solution chamber 30. That is, the dissolution liquid can flow from the dissolution liquid chamber 30 to the needle tip end side through the small gap formed between the upper portion of the sidewall of the 2 nd needle part and the inner wall of the dissolution liquid chamber 30, pass through the seal part 29, and pass through the liquid flow-purpose groove 28 that is not completely closed by the ridge 24 in contact with the 2 nd needle part. Of course, a through hole (not shown) may be formed as a solution passage to penetrate the 2 nd needle portion 25 itself.

When the dissolution system 1 is assembled and used by the capsule holder 3 and the dissolution liquid holder 4 described above, as shown in fig. 8, the capsule 6 is put into the capsule housing chamber of the capsule holder 3, and the dissolution liquid 7 is put into the dissolution liquid chamber 30, and inserted into the end of the capsule holder 3 on the opening 10 side from the opening 23 of the dissolution liquid holder 4. At this time, the capsule 6 is disposed between the needle tip 27 of the 2 nd needle portion 25 and the needle tip 12 of the 1 st needle portion 11 which are opposed to each other. The assembled dissolution system in use of fig. 8 corresponds to the dissolution system in use of fig. 1, and the capsule 6 is disposed in contact with the needle tip 27 of the 2 nd needle part 25 and the needle tip 12 of the 1 st needle part 11.

In order to maintain the above state shown in fig. 1 and 8, as shown in fig. 9, the above-described seal portion 19 is formed on the outer wall of the capsule holder 3 in the vicinity of the opening 10, and a step 33 is formed on the inner wall of the solution holder. When the capsule holder 3 is inserted into the solution holder 4, the sealing portion 19 engages with the step 33, thereby temporarily locking the capsule holder 3 to the solution holder 4. As shown in fig. 1 and 8, the locking position is a position (initial state) at which the needle tip 12 of the 1 st needle part 11 and the needle tip 27 of the 2 nd needle part 25 contact the capsule 6. When a predetermined or more force is applied from this initial state, the sealing portion 19 moves over the step 33, and the capsule holder 3 and the solution holder 4 further approach each other.

Next, the operation of the dissolution system 1 in use according to the present embodiment will be described.

As shown in fig. 2, from the initial state shown in fig. 1, the solution holder 4 is pressed in the direction of arrow a with a force of a predetermined value or more. This operation can be performed, for example, by placing the index and middle fingers on the flange 16a and pressing the closed end of the solution holder 4 with the thumb.

By the above-described pressing, the dissolution liquid holder 4 and the capsule holder 3 are further brought close to each other, and the needle tip 12 of the 1 st needle part 11 and the needle tip 27 of the 2 nd needle part 25 are further brought close to each other from a position contacting the capsule 6, and therefore, the outer skin of the capsule 6 is pierced, and the capsule 6 is opened. The medicine powder inside is released from the opened capsule 6 into the capsule accommodating chamber 13.

On the other hand, when the 2 nd needle part 25 pierces the capsule 6, the 2 nd needle part 25 receives resistance and moves relatively upward closer to the closed end 22 with respect to the solution holder 4 pushed and moved. As a result, as shown in fig. 7, the sealing of the dissolution liquid chamber 30 is released, and the dissolution liquid flows into the capsule housing chamber 13 through the liquid flow-purpose groove 28. The dissolution liquid flowing into the capsule housing chamber 13 dissolves the released medicament powder, thereby generating the solution 9. As shown in fig. 2, the pressing of the solution holder 4 into the capsule holder 3 is stopped by the engagement of the edge of the solution holder 4 around the 2 nd opening with the large diameter portion 3b of the capsule holder 3. At this locking time, the solution enters the capsule housing chamber 13 maintaining a predetermined volume. Therefore, according to the present embodiment, an in-use dissolution system is realized in which the drug powder stored in the capsule 6 can be dissolved in a dissolution liquid at the time of use.

Fig. 2 shows a state in which the solution in the capsule housing chamber 13 is drawn into the outflow groove 36 of the ejector 2 by pulling the piston 38 of the ejector 2 in the direction B. The ejector according to the present embodiment will be described below.

(ejector)

In fig. 10 is shown the ejector 2 removed from the dissolution system 1 in use.

As shown in the figure, the ejector 2 includes: a tip portion 35 detachably engaged with the ejector chamber (14 in fig. 3 (b)) when the ejector 2 is attached to the dissolution system 1 in use; an outflow chute 36 extending rearward from the tip 35; a piston 38 configured to be slidable in the axial direction in the internal space of the outflow groove 36; a housing 37 covering the tip portion 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.

The tip portion 35 has a tip hole 34 that matches the needle hole 17 (fig. 3 (b)) after being engaged in the ejector chamber 14. The tip hole 34 communicates with the inner space of the outflow groove 36 via a conduit 61. When the ejector 2 is mounted to the dissolution system 1 in use, the upper portion of the housing 37 is also detachably engaged with the ejector chamber (15 in fig. 3 (b)). The housing 37 further includes a finger-hooking flange 42 projecting radially outward.

When the ejector 2 is attached to the dissolution system 1 in use, the plunger portion 32 is pulled so as to be away from the spout 36, and the piston 38 moves so as to be away from the pointed end portion 35, whereby the solution in the capsule housing chamber 13 flows into the internal space of the spout 36 through the pointed end hole 34 and the conduit 61.

On the other hand, when the ejector 2 is removed from the in-use dissolution system 1, the plunger portion 32 is pushed so as to approach the spout 36, and the plunger 38 moves so as to approach the tip portion 35, whereby the solution in the spout 36 is ejected to the outside through the catheter 61 and the tip hole 34. The tip portion 35 may be configured as a nozzle portion for spraying the solution.

The ejector 2 according to the present embodiment includes a double-extrusion mechanism that can eject the solution sucked twice in the 1 st and 2 nd predetermined amounts without switching operation.

The structure of the plunger portion 32 of the ejector 2 including the double extrusion mechanism will be described in detail below with reference to fig. 10, 11, and 12.

As shown in fig. 10, the plunger portion 32 includes: a piston rod 39 extending axially downward from the piston 38; a control rod 45 which is arranged in parallel with the piston rod 39 and extends downward from the piston 38; a lower end plate 51 disposed below the piston rod 39 and the control rod 45; the outflow groove ring 43; and the main part of the two-stage extrusion mechanism is disposed in the outflow groove ring 43. The piston rod 39 includes a 1 st locking protrusion 41 that protrudes radially outward from the outer surface of the piston rod 39, the housing 37 includes a 2 nd locking protrusion 40 that protrudes radially inward from the inner wall of the housing 37, and the 1 st locking protrusion 41 engages with the 2 nd locking protrusion 40 to define the bottom dead center of the piston 38 and prevent the piston 38 from coming off. Further, a seal portion 48 (fig. 11 c and 12 d) for sliding in a sealed state inside the spout is formed at the tip end portion of the piston 38.

As shown in fig. 11 and 12 (particularly fig. 11 (b) and 12 (c)), the plunger operating portion 50 disposed in the outflow groove ring 43 includes: a boss 54 extending upward from the lower end plate 51 so as to be engageable with the lever 45; and a spring 52 provided between the lower end plate 51 and the lower end of the piston rod 39 and having an increased diameter when contracted. Further, the control rod 45, which is one of the constituent elements of the double extrusion mechanism, is capable of flexing to displace in the radial direction from a position in parallel with the piston rod 39, and the control rod 45 includes: a control rod lower portion 55 provided at a lower end of the control rod and engageable with the inclined portion 52a of the spring after the diameter is expanded; a lever folding portion 56 formed above the lever lower portion 55 and protruding to one side of the radially outer protrusion 54; a 1 st recess 57 formed between the lever lower portion 55 and the lever folded portion 56; a 2 nd recessed portion 58 formed adjacent to the upper side of the lever folded-back portion 56; a flat portion 59 formed above the 2 nd concave portion 58; and a stopper 47 protruding radially outward at a predetermined position of the lever 45 above the flat portion 59. The spring 52 has a slope portion 52a (fig. 12 c) in which the angle with respect to the axial direction increases and the length in the radial direction increases after contraction, and the projection 54 includes a cylindrical tip portion 54 and a rod 53 extending from the lower end plate 51 to the tip portion for supporting the cylindrical tip portion.

Next, the operation of the double extrusion mechanism of the ejector 2 according to the present embodiment will be described with reference to fig. 13.

The ejector 2 can squeeze the solution in the outflow groove 36 by, for example, putting the index finger and the middle finger on the flange 42 (fig. 10) and pressing the lower end plate 51 with the thumb.

As shown in fig. 13, in an initial state where the lower end plate 51 is not pressed and the spring 52 is not biased, the projection 54 is housed in the 1 st recess 57. In this initial state, the stopper 47 is located radially inward of a radial position where it can engage with the lower edge of the spout.

Next, after the lower end plate 51 is pressed (step (1)), the spring 52 contracts and expands radially outward, and therefore 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 together with the lower end plate 51, whereby the lever 53 is bent and folded back radially outward, and the boss 54 goes over the lever folded-back portion 56.

When the lower end plate 51 is also pressed after the projection 54 passes over the lever folded portion 56 (step (2)), the spring 52 is in a further contracted state (for example, a most contracted state), and in this state, the lever 45 and the stopper 47 are positioned radially outward of the initial state against the force of the projection 54 to return radially inward by the engagement of the inclined portion 52a of the spring with the lever lower portion 55, and the projection 54 is engaged with the flat portion 59 of the lever 45. At this time, the stopper 47 moves to a radial position where it can engage with the lower edge of the spout 36.

When the lower end plate 51 is pressed in the state (for example, the most contracted state) in which the spring 52 is further contracted as described above (step (3)), the force of the pressing is not absorbed by the spring 52 and therefore serves to move the piston rod 39 and the piston 38 in the upward direction. That is, the piston rod 39 and the piston 38 move upward until the stopper 47, which has moved radially outward, engages with the spout 36, and thereby the 1 st predetermined amount of the solution filled in the internal space of the spout 36 is discharged from the tip hole 34 through the conduit 61.

After the first ejection is completed, the finger is temporarily moved away from the lower plate 51 (step (4)). Since the push-down end plate 51 is no longer pushed, the force with which the inclined portion 52a of the spring pushes the lever lower portion 55 is reduced, and therefore the boss 54 pushes the lever 45 radially further inward and returns, and the spring 52 in a further contracted state extends until the boss 54 enters the 2 nd recessed portion 58 and is locked by the lever folded-back portion 56. At this time, the boss 54 moves the lever 45 and the stopper 47 further inward in the radial direction, thereby releasing the stopper 47.

When the push-down end plate 51 is pressed again after the stopper 47 is released (step (5)), the piston rod 39 and the piston 38 move upward, and the 2 nd predetermined amount of the solution remaining in the outflow groove 36 is discharged from the tip hole 34.

When the use dissolution system to which the ejector 2 described above is applied is used, for example, in the case of a vaccine or the like, a powder and a dissolution liquid are mixed at the time of use, and the solution is moved to the outflow groove side of the ejector 2, so that the solution can be sprayed into the nasal cavities of the two holes of the nose, respectively, and administered. The 1 st predetermined amount and the 2 nd predetermined amount may be equal to each other, but may be arbitrarily changed to different ratios.

In addition, since the ejector 2 according to the present embodiment opens the control lever 45 by the inclined portion 52a of the spring, the stopper 47 can be reliably locked compared to the double extrusion mechanism of the related art. Further, the stopper 45 can be reliably released by drawing the control lever 45 inward by the projection 54.

(other example of Using ejector)

The ejector 2 described above can also be used for applications other than the dissolution system 1 in use.

Fig. 14 shows an example of use of the ejector 2 for sucking and administering the drug solution in the vial. Fig. 15 shows a step of preparing the drug solution in the vial.

First, as shown in fig. 15, the powdered medicine 77 is put into a vial 80 and sealed by a cap 82, thereby being stored in a state where moisture does not enter. When preparing the drug solution, the needle 91 of the syringe 90 containing the solution is inserted into the cap 82, and the solution is injected into the vial 80. The injected solution dissolves the powdered chemical 77 to generate a chemical (solution) 81. When the ejector is used, the vial 80 and the ejector connection adapter 70 are fitted into the vial 80.

As shown in fig. 14, the connection adapter 70 includes a vial-side holding portion 71a and an ejector-side holding portion 71 b. A recess for inserting a vial 80 containing a drug solution 81 from the cap side is formed in the vial-side holding portion 71a, and the tapered needle portion 72 extends from the center of the recess, and is sealed by a pierceable cap 82. The needle portion 72 is formed with a through hole 73 penetrating the connection adapter 70. The ejector-side holding portion 71b is formed with a recess into which the tip portion 35 of the ejector 2 described above is inserted. After vial 80 containing drug solution 81 is fitted to vial-side holding portion 71a of connection adapter 70, cap 82 is opened by needle portion 72. In this state, after 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 is fitted to the tip hole 34 of the ejector 2. Thus, the chemical liquid 81 can reach the tip hole 34 of the ejector 2 through the through hole 73 of the needle portion 72.

In the state shown in fig. 14, when the piston rod 39 is pulled downward, the piston 38 moves downward in the outflow groove 36 (see fig. 2 and 13), and the drug solution 81 in the vial 80 is sucked into the outflow groove 36 through the through hole 73 of the needle portion 72 and the tip hole 34 of the ejector 2. When the ejector 2 is removed from the connection adapter 70 after the chemical liquid suction, the chemical liquid 81 can be ejected in two times as described above.

In addition to the example of fig. 14, the ejector 2 according to the present embodiment can be considered. For example, the following may be provided: connected with a glass bottle containing viscous liquid medicine, the content liquid is sucked up and taken out, and is sprayed out twice. In addition, the reagent can be used for reagent applications such as sucking up a sample and dispensing it into the reaction solutions a and B.

The embodiments of the present invention have been described above, but the present invention is not limited to the above embodiments, and can be arbitrarily and appropriately modified within a desired range.

For example, in the above example, the liquid flow-purpose groove 28 (fig. 5 (a) to (c)) is formed in the side wall of the 2 nd needle portion 25 of the solution holder to take out the solution from the solution chamber. In the present invention, the present invention is not limited to this example, and a liquid flow passage for allowing the dissolution liquid to flow from a position closer to the needle tip 27 than the seal portion 29 of the 2 nd needle portion 25 to the needle tip 27 may be formed. As such a liquid flow path, for example, as shown in fig. 16 (a) and (b), it may be configured such that: the through-hole 28a for the liquid flow passing through the inside of the 2 nd needle part is formed not as a groove of the side wall as the groove 28 for the liquid flow. The through hole 28a for liquid flow penetrates the side wall of the base 26 in the radial direction from a position below the seal 29, and forms a through hole in the axial direction inside the base, and penetrates to a position close to the needle tip 27.

Description of the reference numerals

1 … dissolution system in use; 2 … ejector; 3 … capsule holder; 3a … small diameter section; 3b … large diameter part; 4 … solution bracket; 5 … dissolving and spraying system in use; 6 … capsule; 7 … dissolving solution; 9 … solution; 10 … opening (1 st opening); 11 … needle part 1; 12 … needle tip; 13 … capsule-containing chamber; 14. 15 … ejector chamber; 16 … opening (opening No. 3); 16a … flange; 17 … needle hole portion; 18 … through holes; 19 … sealing part; 20 … ridges; 21 … a ridge; 22 … closed end; 23 … opening (2 nd opening); 24 … annular ridges; 25 … needle 2; 26 … base portion; 27 … needle tip; 28 … liquid flow general groove (liquid flow passage); 28a … through-holes (liquid flow passages) for liquid flow; 29 … seal; 30 … liquor compartment; 31 … air; a 32 … plunger portion; 33 … steps; 34 … tip hole; 35 … tip portion; 36 … flow out of the trough; 37 … a housing; 38 … piston; 39 … piston rod; 40 … No. 2 stop projection; 41 … item 1 stop projection; 42 … finger flange; 43 … flow out of the groove ring; 45 … lever; 47 … stopper; a 48 … seal; 50 … plunger operating parts; 51 … lower end plate; 52 … spring; the inclined portion of 52a … spring; a 53 … lever; 54 … are raised; 55 … control rod lower part; 56 … lever return; 57 … recess 1; 58, 58 …, 2 nd recess; 59 … flat portion; 60 … solution; 61 … catheter; 70 … connecting an adapter; 71a … pipe medicine bottle side holding part; 71b … ejector-side holding part; 72 … needle portion; 73 … through holes; 77 … pharmaceutical powder; 80 … tube medicine bottle; 81 … medicinal liquid; 82 … cover; 90 … syringe; 91 … needle.

Claims

1. A dissolution system for use in which,

the dissolution system for use comprises:

a capsule holder having a hollow inner space and formed in a cylindrical shape; and

a solution holder having a hollow inner space and formed in a cylindrical shape,

the capsule holder is provided with:

a 1 st opening formed at one end; and

a 1 st needle part configured to partition an inner space of the capsule holder, the 1 st needle part having a needle hole part penetrating the 1 st needle part, a needle tip of the 1 st needle part facing the 1 st opening part,

a capsule housing chamber capable of housing a capsule in which a predetermined substance is encapsulated is formed in an inner space of the capsule holder between the needle tip of the 1 st needle part and the 1 st opening part,

the solution scaffold is provided with:

a closed end portion at one end portion closing the inner space;

a 2 nd opening formed at an end opposite to the closed end; and

a 2 nd needle part slidable in the internal space of the solution holder, the 2 nd needle part having a needle tip facing the 2 nd opening,

the inner space between the bottom surface of the 2 nd needle part and the closed end part forms a solution chamber for putting a solution,

the 2 nd needle part is provided with a dissolving solution passage for the dissolving solution to come out from the dissolving solution chamber,

the capsule holder and the solution holder are slidably fitted to each other in a state where the needle tip of the 1 st needle part and the needle tip of the 2 nd needle part face each other, and the capsule can be arranged between the needle tip of the 1 st needle part and the needle tip of the 2 nd needle part,

when the solution holder is pushed into the capsule holder, the needle tip of the 1 st needle part and the needle tip of the 2 nd needle part unseal the capsule, and the solution holder is locked in a state where the predetermined substance released from the capsule and the solution flowing from the 2 nd needle part are stored in the capsule housing chamber.

2. A dissolution system for use in which,

the dissolution system for use comprises:

the capsule holder is provided with:

a 1 st opening formed at one end; and

the solution scaffold is provided with:

a closed end portion at one end portion closing the inner space;

a 2 nd opening formed at an end opposite to the closed end; and

the capsule is disposed in the capsule housing chamber in a state of being in contact with the needle tip of the 1 st needle part and the needle tip of the 2 nd needle part in an initial state in which the dissolution liquid chamber is sealed,

after the dissolution solution holder is pressed against the capsule holder from the initial state, the 1 st needle portion and the 2 nd needle portion, which are further close to each other, pierce the outer skin of the capsule and unseal the capsule, thereby releasing the predetermined substance in the capsule housing chamber, and the dissolution solution chamber is unsealed, whereby the dissolution solution is pushed out from the dissolution solution chamber to the capsule housing chamber through the dissolution solution passage, and the released predetermined substance is dissolved by the dissolution solution to generate a solution,

at least one annular ridge extending around the inner circumference is formed on the inner wall of the solution holder to slidably hold the 2 nd needle part,

a seal portion extending around the outer periphery is provided on the side wall of the 2 nd needle portion, and the seal portion engages with the annular ridge from an upper side closer to the closed end in the initial state to seal the dissolution liquid chamber,

at least one liquid passage for allowing the solution to flow from a position closer to the needle tip than the seal portion toward the needle tip is formed in the 2 nd needle portion.

3. The in-use dissolution system of claim 2 wherein,

when the 2 nd needle portion pierces the capsule, the 2 nd needle portion receives resistance and moves relatively to the solution holder pushed and moved upward closer to the closed end portion, and the seal of the solution chamber is released, whereby the solution flows into the capsule accommodating chamber through the liquid flow passage.

4. A dissolution system for use in which,

the dissolution system for use comprises:

the capsule holder is provided with:

a 1 st opening formed at one end; and

the solution scaffold is provided with:

a closed end portion at one end portion closing the inner space;

a 2 nd opening formed at an end opposite to the closed end; and

the capsule holder is inserted into the solution holder from the 2 nd opening,

in the capsule holder, a seal portion is provided around the outer periphery of the vicinity of the 1 st opening portion.

5. The in-use dissolution system of claim 4 wherein,

a step is formed on the inner wall of the solution bracket,

when the capsule holder is inserted into the solution holder, the capsule holder and the solution holder are temporarily locked by the engagement of the sealing portion with the step to bring the capsule holder into the initial state, and the solution holder is pressed against the capsule holder with a predetermined force or more from the initial state, whereby the sealing portion goes over the step, and the capsule is opened by the needle tip of the 1 st needle portion and the needle tip of the 2 nd needle portion which are further close to each other.

6. A dissolution system for use in which,

the dissolution system for use comprises:

the capsule holder is provided with:

a 1 st opening formed at one end; and

the solution scaffold is provided with:

a closed end portion at one end portion closing the inner space;

a 2 nd opening formed at an end opposite to the closed end; and

the capsule holder is inserted into the solution holder from the 2 nd opening,

the capsule holder is provided with: a small diameter portion having a diameter insertable from the 2 nd opening of the solution holder; and a large diameter portion having a diameter larger than the 2 nd opening, wherein the edge of the solution holder around the 2 nd opening is engaged with the large diameter portion, thereby further press-fitting and locking the solution holder into the capsule holder.

7. The in-use dissolution system of any one of claims 1 to 6 wherein,

the capsule holder has an inner wall defining the capsule accommodating chamber, and a plurality of ridges projecting radially inward from the inner wall and extending in an axial direction to hold the capsule.

8. A dissolution system for use in which,

the dissolution system for use comprises:

the capsule holder is provided with:

a 1 st opening formed at one end; and

the solution scaffold is provided with:

a closed end portion at one end portion closing the inner space;

a 2 nd opening formed at an end opposite to the closed end; and

a finger-hooking flange is provided around the outer periphery of an end portion of the capsule holder opposite to the end portion of the capsule holder where the 1 st opening is formed.

9. A dissolution system for use in which,

the dissolution system for use comprises:

the capsule holder is provided with:

a 1 st opening formed at one end; and

the solution scaffold is provided with:

a closed end portion at one end portion closing the inner space;

a 2 nd opening formed at an end opposite to the closed end; and

an ejector that sucks the solution in the capsule housing chamber through the needle hole is engaged with an end portion of the capsule holder on the opposite side of the end portion of the capsule holder where the 1 st opening is formed.

10. The in-use dissolution system of claim 9 wherein,

a 3 rd opening part is formed at the end part of the opposite side of the capsule holder,

an ejector chamber in which at least a part of the ejector is detachably engaged is formed in an inner space of the capsule holder from the 3 rd opening to the bottom surface of the 1 st needle portion.

11. The in-use dissolution system of claim 10 wherein,

the ejector includes:

a tip section detachably engaged with the ejector chamber, the tip section having a tip hole that matches the pinhole section after being engaged with the ejector chamber;

an outflow chute extending rearward from the tip section, an inner space of the outflow chute communicating with the tip hole;

a piston configured to be slidable in an axial direction in an inner space of the spout; and

a plunger portion extending axially from the piston,

by pulling the plunger portion away from the spout, the piston moves away from the pointed end portion, whereby the solution flows into the inner space of the spout through the pointed end hole,

by pressing the plunger portion so as to approach the spout, the plunger moves so as to approach the tip portion, and the solution in the spout is ejected through the tip hole.

12. The in-use dissolution system of claim 11 wherein,

the plunger portion includes:

a piston rod extending downward in an axial direction from the piston;

a control rod which is arranged in parallel with the piston rod and extends downward from the piston;

a lower end plate disposed below the piston rod and the control rod;

a projection extending upward from the lower end plate so as to be engageable with the lever; and

a spring disposed between the lower end plate and the lower end of the piston rod, the spring expanding in diameter when contracted,

the control rod is capable of flexing to displace radially from a position alongside the piston rod,

the control lever is provided with:

the lower part of the control rod is arranged at the lower end of the control rod and can be clamped with the expanded spring;

a lever folding portion formed above a lower portion of the lever and protruding to one side of the projection radially outward;

a 1 st recess formed between the lever lower portion and the lever folded portion;

a 2 nd recess formed adjacent to an upper side of the lever folded portion;

a flat portion formed above the 2 nd recess; and

and a stopper protruding radially outward at a predetermined position of the lever above the flat portion.

13. The in-use dissolution system of claim 12 wherein,

in an initial state where the lower end plate is not pressed and the spring is not urged, the projection is housed in the 1 st recess,

after the lower end plate is pressed, the spring contracts and is clamped with the lower part of the control rod,

the projection moves upward together with the lower end plate while the lower end plate is pressed, whereby the projection passes over the lever folded-back portion,

when the lower end plate is also pressed after the projection passes over the lever folded-back portion, the spring is brought into a further contracted state in which the lever and the stopper are positioned radially outward of the initial state against the projection by engagement of the spring with the lower portion of the lever, and the projection is engaged with the flat portion of the lever,

when the spring is further contracted and the lower end plate is pressed, the piston rod and the piston move upward until the stopper moved radially outward engages with the spout, whereby a 1 st predetermined amount of the solution in the solution filled in the internal space of the spout is discharged from the tip,

the force with which the spring presses the lower portion of the lever is reduced by no longer pressing the lower end plate, so that the boss presses and returns the lever further inward in the radial direction, the spring in the further contracted state extends until the boss enters the 2 nd recessed portion and is caught by the lever folded-back portion, the lever and the stopper are moved further inward in the radial direction by the boss, and the stopper is released,

when the stopper is released and the lower end plate is pressed again, the piston rod and the piston move upward, and the 2 nd predetermined amount of the solution remaining in the spout is discharged from the tip portion.

14. The in-use dissolution system of claim 12 wherein,

the spring has an inclined portion which increases in angle with respect to the axial direction and increases in length in the radial direction after contraction.

15. The in-use dissolution system of any one of claims 12 to 14 wherein,

the projection includes a cylindrical tip portion and a rod extending from the lower end plate to the tip portion for supporting the cylindrical tip portion.

16. The in-use dissolution system of any one of claims 12 to 14 wherein,

a housing is provided that covers at least the outflow groove and a part of the piston rod.

17. The in-use dissolution system of claim 16 wherein,

the piston rod is provided with a 1 st locking protrusion protruding from the outer surface of the piston rod to the radial outer side,

the housing is provided with a 2 nd locking projection projecting from the inner wall of the housing to the radial inner side,

the 1 st locking projection is engaged with the 2 nd locking projection to define a bottom dead center of the piston.

18. The in-use dissolution system of claim 16 wherein,

the housing includes a finger-hooking flange projecting radially outward.

19. The dissolution in use system of any of claims 1, 2, 4, 6, 8, and 9, wherein,

the prescribed substance is a solid powdered medicament.