WO2002011793A1 - Kit preparation syringe, intermediate slide valve for syringes, and kit preparation - Google Patents

Abstract

A kit preparation syringe, which is a syringe used for syringe type kit preparations, comprising an intermediate slide valve received in a syringe cylinder, with medicine liquid filled at least on the plunger operating side of the intermediate slide valve, wherein the intermediate slide valve comprises an annular lip contacting the inner wall of the syringe cylinder to water-tightly divide the space into a syringe cylinder needle side space and a plunger operation side space of the intermediate slide valve, a through-hole bypassing the annular lip and establishing communication between the syringe cylinder needle side space and the plunger operation side space, a closing means for closing the through-hole, and a seal breaking means for breaking the seal when an injecting operation causes the intermediate slide valve to reach the syringe cylinder needle side terminal or its vicinity, the arrangement being such that reliable, successive medicine liquid injections is made possible while dispensing with a special syringe cylinder.

Description

 Specification

 Syringe for kit preparation, intermediate slide valve for syringe, and kit preparation

 [Technical field]

 TECHNICAL FIELD The present invention relates to a syringe for a syringe-type kit preparation, an intermediate slide valve for a syringe, and a syringe-type kit preparation capable of sequentially injecting two or more drugs in one operation without mixing the drugs.

 [Background technology]

 Some syringe-type kit preparations can inject multiple drugs in a single operation. For example, treatment requires two or more drugs with different physical, chemical, or pharmacological properties, but cannot be used as a mixture due to problems such as stability (for example, an acidic drug and an Combination with a nervous system drug) or injecting a therapeutic agent (second agent) into the injection site, causing severe pain at the site of administration. It is known that a drug is administered as a first drug.

 Among these, the first agent is a local anesthetic such as lidocaine hydrochloride, such as osteoarthritis of the knee and shoulder periarthritis, and the effect of needle thickness, pH and osmotic pressure ratio are In addition, it is widely used around the world, and it is widely used around the world for venous blood vessels, although it is widely used around the world, such as sodium hyaluronate, which may cause severe pain to the affected area of the patient due to poor medical procedures etc. A typical example is a combination with an induction anesthetic (propofol), which is known to cause severe pain.

 The present inventors have proposed various syringes suitable for such a syringe-type kit preparation. Among such syringes for kits, a serial sequential dispensing syringe will be described with reference to the drawings.

Fig. 12 shows a syringe-type key that can inject two drugs in one operation. FIG. 3 is a model diagram showing an example of a kit preparation.

 The syringe shown here has a syringe barrel having an injection needle connection part at one end and an opening at the other end, and a plunger inserted through the opening, wherein the injection needle in the syringe barrel is provided. Between the connecting part and the plunger, two or more partitioning parts (sliding valves) for dividing the internal space of the syringe cylinder into a plurality of chambers in a watertight manner are slidably provided. The injection agent is stored in two or more chambers formed between the plungers, and the plunger moves to the injection needle side to allow the respective chambers to communicate with the injection needle connection portion (communication passage 1). This is a kit preparation using an in-line sequential dispensing syringe provided with c)).

 The first agent is filled with a reference numeral 5 in a watertight space defined by an injection cylinder 1, an intermediate sliding valve (middle stopper) 3 of the kit preparation, and a cap 4 at a syringe needle connection portion 1a of the injection cylinder 1. Have been.

 Further, the second agent is filled with degassing by a vacuum filling plugging method as reference numeral 6 as a watertight space composed of the injection cylinder 1, the intermediate sliding valve 3, and the plunger sliding valve 2. These are sterilized by filling before or after filling. Fig. 12 (b) is a cross-sectional view (model drawing) of the L-shaped part of Fig. 12 (a). Such a kit preparation is used prior to use, as shown in Fig. 12 (c). The injection needle 7 is attached to the injection needle connection part 1a of the injection needle.

 At this time, if air bubbles such as air are present in the portion of the first agent 5, the air bubbles can be removed by operating the plunger operation section 2a with the injection needle side up. When the injection amount of the first agent is particularly reduced, the plunger operation section 2a is operated at this stage to reduce the amount of the first agent 5.

Next, the injection needle 7 is pierced into the required injection site, and then the plunger operation section 2a is moved to the injection needle side to inject the first agent 5 (see FIG. 13 (a)). Thereafter, when the operation of the plunger operation section 2a is further continued, the second agent 6 is injected into the injection required site this time. At this time, the intermediate sliding valve 3 moves toward the syringe needle and reaches the tip of the syringe barrel, but since the た め portion 3a provided on the intermediate sliding valve 3 contacts the syringe barrel bottom 1, the sliding valve is Since the communication channel 1c is bypassed without being in close contact with the syringe barrel bottom 1b, even if these sliding valves are moved to the syringe barrel bottom 1b side, the second valve 6 can be transferred to the injection needle 7. Supply passage is secured.

 FIG. 13 (b) shows a state in which the operation of the plunger operation section 2a has been completed and the injection of the second agent 6 has been completed. Normally, the injection needle is removed from the required injection site in this state, but if the injection amount of the second agent 6 is to be reduced, the injection needle is pulled out of the injection site with the second agent 6 remaining in the syringe 1 May be.

 In such an in-line sequential dispensing syringe-type kit preparation, when the first agent is an infiltration anesthetic and the second agent is a therapeutic agent, the second agent 6 is confirmed at the site where the first agent 5 was injected. Since the second agent 6 is actually injected, painless or less painful injection can be performed even if the second agent 6 has a significantly different pH, osmotic pressure, temperature, etc. compared to the body fluid.

 As described above, the syringes shown in FIGS. 12 and 13 seemed to be excellent syringes with good operability, but had an unexpected problem when considering mass production. In the case of in-line sequential dispensing syringe-type kits, post-sterilization with normal autocrepes may not be possible due to the nature of the drug, or it may reduce the burden on patients or may be related to the government's policy on controlling medical expenses. Considering cost, long-term stability, etc., there is a lot of unsolved problems in cyclic polyolefin, which is regarded as the next-generation hope for the material of injection syringes. I have to use something.

However, when the syringes shown in Figs. 12 and 13 are manufactured using glass as a raw material, it is difficult to improve the positional accuracy of the installation of the communication passage 1c with current mass production technology. It turned out to be.

 The syringe barrel 1 shown in FIGS. 12 and 13 is manufactured by processing a normal glass syringe barrel manufactured from a glass tube as a raw material. That is, the communication passage 1c is formed by heating and / or immediately after heating the corresponding portion where the communication passage 1c of the ordinary glass syringe is provided, or by vacuum suction from the outside of the syringe. The position of the communication passage 1c at that time is determined based on the needle-side surface of the finger grip 1d of the syringe barrel 1.

 However, the accuracy of the position and the shape of the finger grip 1d is low in a general glass syringe, and the position accuracy of the communication passage 1c formed based on the finger grip 1d having the low position / shape accuracy is low. Furthermore, due to restrictions on the formation of the communication passage 1c, the communication passage 1c must be formed at a position slightly away from the bottom 1b of the injection cylinder, and as a result, before the injection operation of the first agent 5 is completed. The second agent 6 reaches the first agent 5 side through the communication passage 1c and is mixed with the first agent 5 for injection, or the injection of the first agent 5 has been completed. Nevertheless, it can be seen that the plunger side end surface of the intermediate sliding valve 3 cannot reach the plunger side end of the communication passage 1c, and a situation may occur in which injection of the second agent 6 cannot be performed at all. There is a possibility that a problem may occur that is unacceptable as a kit product that requires certainty in injecting multiple drugs sequentially in a single injection operation.

For this reason, we examined ways to improve the manufacturing accuracy of glass-type syringes. However, in this case, small-scale changes in the conventional production line for syringes could not cope with the situation, and it was necessary to completely change the manufacturing equipment and method itself. Therefore, it was found that mass production was difficult. On the other hand, we considered strict quality control in the conventional production line, for example, by conducting a full product inspection to remove all syringes that could cause inconvenience, and then responding. It was found that the cost was low and the yield was not expected to improve in the future, so it was not practical in terms of cost. Furthermore, we examined whether the position accuracy of the re-communication passage could be improved by partially changing the material of the syringe and changing the vicinity of the syringe communication passage to plastic. However, the cost increase of the syringe barrel in that case proved to be so great that it was equally impractical.

 Here, the conventional syringe itself (without a communication passage) is used as the syringe itself. However, a hollow portion is provided in the intermediate slide valve, and when the operation of injecting the pre-solution is completed, the pressure in the post-solution is changed to an intermediate value. A technique has been proposed in which a part of a sliding valve is deformed to form a fluid passage between the side surface and the inner wall of a syringe cylinder (Japanese Patent Application Laid-Open No. H10-5057486). JP-A-10-80485).

 However, the conditions for forming the liquid passage due to such deformation of the intermediate slide valve depend on the dynamic pressure applied to the intermediate slide valve and the flexibility of the material forming the intermediate slide valve. Not only when used in the ground or in extremely cold regions, but also depending on conditions such as how to apply force from the operator, the viscosity of the drug, the temperature, and the thickness of the injection needle used. The reliability was extremely low, and it was not possible to sufficiently meet the required performance of reliably injecting multiple drugs in a single injection operation.

 In addition, in the syringe proposed in Japanese Patent Application Laid-Open No. 8-2945332, as shown in FIG. 14 (a), an intermediate sliding valve S1 has a through hole S11 penetrating the front and rear thereof. A closing body S12 made of plastic or the like is fitted in the through-hole S11 to close the through-hole S11.

By operation of the plunger S2, the intermediate slide valve S1 moves to the injection needle side. At this time, the intermediate slide valve S1 is provided at the center of the inner side of the bottom of the injection cylinder S3 needle side S31 toward the plunger operation side. The closing body pushing member S 3 1 1 pushes out the closing body S 1 2 of the intermediate sliding valve S 1, and the closing body S 1 2 is formed of the intermediate sliding valve S 1 by the elastomeric property of the intermediate sliding valve S 1. Quickly moved to the rear storage section S13 of the closed body (Fig. 14 (b) At that time, the through-hole S11 of the intermediate sliding valve S1, which was closed by the closing body S12 at that time, is opened, and the intermediate sliding valve S1 is filled with the chemical liquid S5 on the plunger operation side. It can be moved to the 1st needle side.

 However, the intermediate sliding valve S 1 is at the moment when the closing body S 12 moves to the rear storage section S 13 of the closing body and the through hole S 11 is opened, that is, as shown in FIG. 14 (b). Then, the pressure for advancing forward is released, and the movement to the needle side is interrupted and ended. As a result, the needle for the drug solution S 4 existing in the space between the intermediate sliding valve S 1 and the bottom of the syringe barrel is released. The single and direct supply to is stopped, and the chemical solution S5 supplied through the through-hole S11 of the intermediate sliding valve S1 is gradually mixed and supplied to the needle. In other words, in the case of the syringe shown in Fig. 14, the performance as a syringe for kit preparations that requires certainty in injecting multiple drugs sequentially without being mixed by one injection operation is required. Can not be obtained.

 In addition, the through hole S11 must be large enough to allow the closure S12 to move, and the dead volume of the closure extrusion member S311 is large, and the weight per kg of sodium hyaluronate etc. It is necessary to fill an extra chemical solution using expensive raw materials such as 500,000 to 600,000 yen, or injection of a predetermined amount becomes impossible.

Further, as described above, since the closing body pushing member S311 is provided so as to protrude toward the plunger operating side at the center of the inside of the bottom of the syringe needle S3 needle side S31, at least the syringe cylinder S3 is provided. It is necessary to be composed of two members, 32 and the needle-side bottom portion S31, and the price of the syringe is high. Furthermore, there is a concern that water vapor or sterilizing gas may enter from the joints of these members during the necessary sterilization after filling the drug, or a problem unique to a kit drug injector filled with a drug for a long time. In addition, there is a concern about leakage of liquid from these joints or invasion of various germs, and it is necessary to use a specially shaped injection cylinder as described above. It is very disadvantageous in cost because it cannot be used.

 Furthermore, in the case of the syringe shown in Fig. 14, it is not possible to cope with the recently required sequential injection of three or more liquids, and if the first chamber is not filled to avoid inconvenience due to the joining of the above members, Only single solution injection is supported.

 The present invention solves such a problem of the conventional technology, that is, using a conventional normal-shaped injection cylinder without a communication passage, a closing body extruding member, and a joint portion, reliably using two liquids. Alternatively, it is an object of the present invention to provide a syringe for kit preparation which can sequentially inject three or more drugs.

 [Disclosure of the Invention]

 As described in claim 1, the syringe for kit preparation of the present invention has an intermediate slide valve inside the injection cylinder, and a syringe-type kit preparation wherein at least the plunger operation side of the intermediate slide valve is filled with a drug solution. In the used syringe, the intermediate slide valve is in contact with the inner wall of the syringe barrel, and an annular lip that watertightly divides a space on the syringe needle side and a space on the plunger operation side of the intermediate slide valve, and a side of the syringe needle bypassing the annular lip. A through-hole communicating the space with the plunger operation-side space, sealing means for sealing the through-hole, and the sealing when the intermediate sliding valve reaches the injection needle side end point or near the end point by injection operation. And a seal release means for releasing the injection.

 According to such a configuration, the medicine can be sequentially and reliably injected sequentially using a conventional normal-shaped injection cylinder having no communication passage or a joint having a fear of liquid leakage or the like. Also, at this time, the material constituting the intermediate sliding valve is not unnecessarily frictionally pierced, so that there is no danger of dropout (coring, etc.) of a part of the material, and the safety is ensured.

Further, the syringe for kit preparation of the present invention is the syringe for kit preparation according to claim 1, wherein the intermediate slide valve has an annular lip and a through hole. The seal means and the seal release means project from the front of the intermediate sliding valve body toward the syringe needle, and the sealing means and the seal releasing means protrude forward from the syringe needle toward the syringe needle as the intermediate sliding valve advances toward the syringe needle. A contact portion that contacts the bottom portion or another intermediate slide valve in front of the intermediate slide valve on the syringe barrel needle side, and the contact portion relatively moves toward the plunger operation side with respect to the intermediate slide valve body. A sliding portion for driving the sealing means by operation to release the sealing of the through hole by the sealing means.

 With such a configuration, reliable operation can be achieved with a simple structure. Further, in the syringe for kit preparation of the present invention, as in claim 3, the abutment portion and the slide portion are integrated with each other to form a slider, as described in claim 3. The slider has a contact portion protruding forward of the injection valve needle side of the intermediate sliding valve body to be housed in the through-hole of the intermediate sliding valve body and to the plunger operating side with respect to the intermediate sliding valve body. A side opening is provided on a surface of the slide portion, which is in contact with the inner wall surface of the through hole of the intermediate sliding valve body portion, and a front opening and a front opening opening in a space on the syringe needle side of the intermediate sliding valve. A liquid passage communicating with the opening and the side opening is provided in the slide portion, the intermediate sliding valve body portion, or between the slide portion and the intermediate sliding valve body portion, and further, the slider is provided in the intermediate sliding valve body portion. Part on the plunger operation side. At the time of sealing before sliding, the side opening is sealed by the inner wall surface of the through hole of the intermediate sliding valve body, and when the slider is opened toward the plunger operation side with respect to the body of the intermediate sliding valve, the side opening is opened. It has a structure that is exposed to the medicine on the plunger operation side so that the medicine on the plunger operation side can be supplied to the syringe needle side of the intermediate sliding valve through the liquid passage hole.

 Such a structure allows for a more reliable operation, a syringe with less dead space, and less residual drug solution.

Note that the front opening that opens into the space on the syringe needle side of the intermediate sliding valve and the liquid passage that communicates with the front opening and the side opening are usually provided in the sliding portion. It may be provided on the body, or may be provided between the slide and the intermediate sliding valve body.

 In addition, the syringe for a kit formulation of the present invention is such that, in the syringe for a kit formulation according to the third aspect, the side opening of the side surface of the slide portion is enlarged in the circumferential direction of the side surface of the slide portion. It has a part.

 With such a configuration, the plunger operation can be performed with a sufficiently light force even with a highly viscous drug solution, and accurate and safe injection can be performed.

 According to a fifth aspect of the present invention, there is provided a syringe for a kit formulation according to the fifth or fourth aspect, wherein the slider has a syringe needle relative to an intermediate slide valve. It has a check part to prevent it from moving forward from the closed position with respect to the side.

 With this configuration, even if the operator operates the plunger to the suction side, or if abnormal vibrations are applied during storage or transportation, or if there is a sudden change in the environment (temperature, etc.), There is no risk that the chemicals before and after the intermediate slide valve will mix or become inoperable.

 Further, according to a sixth aspect of the present invention, there is provided a syringe for kit preparation according to claim 6, wherein the slide for the plunger is provided on the slide valve for the plunger, and the slider is provided with an intermediate slide. It has a recess corresponding to the amount of protrusion of the slider when it is opened, which slides toward the plunger operation side with respect to the valve train body.

 With such a configuration, the medicinal solution filled in the syringe can be injected without leaving it in the syringe, so that generally expensive medicinal solution is not wasted, and accurate injection of the injection amount is possible. .

Here, at least the vicinity of the annular lip of the intermediate sliding valve for a syringe used, and furthermore, the portion that comes into contact with the slide portion, preferably the entire intermediate sliding valve, is a rubber or a lubricating component in which a lubricating component is chemically bonded. Consists of chemically bonded plastic It is more preferable that the lubricating component is a rubber chemically bonded in view of having elastomer properties.

 With such a configuration, the sliding properties of the intermediate sliding valve can be improved, and even with a syringe for kit preparation that has a larger number of sliding valves than an ordinary syringe, injection with a smooth and light force is performed. At the same time as the operation becomes possible, a safe syringe can be obtained without using silicone oil, for which safety is partially questioned. The latter effect is remarkable in the preparation of a kit for a syringe in which the contact time between the drug and the sliding valve section is long.

 In order to further improve the operability as a syringe, not only the intermediate slide valve but also the slide valve for the plunger is made of rubber with lubricating components chemically bonded or rubber with chemical bonding. It is preferred that

 Examples of the rubber to which the lubricating component is chemically bonded include nitrile rubber, hydrogenated nitrile rubber, ethylene-propylene-gen rubber, ethylene-propylene rubber, and petroleum rubber. Examples of the plastics to which the lubricating component is chemically bonded include polyesters, polyamides, polypropylenes, polyolefins, and polyurethanes.

In addition, they need to be suitable for pharmaceutical applications that do not have the risk of eluting organic and inorganic substances such as plasticizers and harmful metals that may adversely affect the living body, or do not contain them. Further, these rubbers or plastics must be at least resistant to the intended drug. As such a lubricating component chemically bonded to rubber or plastic, a synthetic oil-based lubricating material is desirable. Such materials include, for example, hydrocarbon-based, polyglycol-based, silicone-based, and fluorine-based materials. These lubricating components are derivatized and chemically bonded to the rubber or plastic. Since the amount of lubricating components chemically bonded has a large effect on lubricity, it is determined after various studies. There is a need to.

 As a chemical bonding method, bonding may be performed by a general means such as an ordinary amide bond or an ester bond, but a group which reacts with a rubber-plastic cross-linking agent is introduced into a lubricating component in advance to perform cross-linking. A method performed at the same time can be adopted.

 When a lubricating material with low reactivity such as fluororesin (polytetrafluoroethylene or a copolymer of perfluoroethylene and other comonomers) is used as a lubricating component, an electrophilic reagent may be used. (Hindered phenols, Grignard reagents, etc.) can be added together with these lubricants during molding to form a chemical bond simultaneously with the crosslinking reaction.

 The size of such a lubricant is preferably not less than 10 jwm and not more than 50 m in diameter. The amount added is preferably from 5 to 60 parts by weight, more preferably from 10 to 50 parts by weight, based on 100 parts by weight of the base rubber component or plastic component.

Hereinafter, an example in which a fluororesin and a silicone-based lubricant are used as a lubricating component will be described in detail. In other words, when the fluororesin or silicone-based lubricant is used as the lubricating component, the sliding valve moves very smoothly and its movement starts smoothly, so that injection into a predetermined place such as intravenous injection becomes easy. Of course, in addition, for example, in the case of a kit preparation, the injection volume may be adjusted according to the patient instead of injecting the entire injection solution in the cylinder. This has the effect of making injection extremely easy. Note that the fluororesin and the silicone-based lubricant, which are lubricants, can be used alone as a lubricating component, but by using both at the same time, better lubricity can be obtained. In the above, the electrophile must be compatible with the base rubber component or plastic component and must not cause obstacles Such compounds include hindered phenols, for example, pentaerythrityl-tetrakis [3- (3,5-t-butyl-4-hydroxyphenyl) propionate], 2,2-thiodiethylenebis [3- ( 3,5-dibutyl-1-propylphenylpropionate], 2,2-thiobis (4-methyl-6-t-butylphenol), N, N'-bis [3- (3,5 —Di-t-butyl-1-hydroxyphenyl) propionyl] hydrazine and the like, and the Grignard reagent include those containing chlorine and iodine such as isopropylmagnesium chloride and isooctylmagnesium iodide.

 It is desirable that these electrophilic reagents are added in an amount of 0.1 to 10 parts by weight, particularly 0.2 to 5 parts by weight, based on 100 parts by weight of the rubber or plastic component as a base. .

 These lubricants are mixed with an electrophile, a rubber component or a plastic component and a cross-linking agent. For example, injection molding is performed and the temperature is set to 140 ° G or more and 200 ° C or less in a mold. By applying a pressure of 2 OMPa or less, if necessary, to a crosslinking treatment by applying a pressure of usually 2 OMPa or less, it is possible to obtain a sliding valve for a syringe in which a lubricating component is chemically bonded. The method can be carried out by a method known as a method for crosslinking a rubber component or a plastic component.

 In addition to the above, various modifiers (antioxidants, cross-linking aids, processing aids, reinforcing agents, softeners, coloring agents, extenders, antioxidants, ultraviolet absorbers, etc.) are added as necessary. Of course, they need to have safety as raw materials for sliding valves for syringes.

In the present invention, a sliding valve for a syringe in which a lubricating component is integrated with a rubber component or a plastic component by chemical bonding has a sufficient lubricating property, but the lubricating component elutes or peels off / dissociates into a drug. Is completely eliminated. Also, since the sliding valve itself has lubricity, silicone coating There is no need to use it in combination with a treatment or a lubricating film, or the amount used in combination can be reduced, thus increasing safety. Such a slide valve is also suitable as a slide valve for an ordinary syringe, but is particularly suitable as a slide valve for a syringe of a kit preparation having a long contact period with a drug solution.

 The contact part, the slide part and the slider made of these must be made of a material that is not easily deformed. Such materials include metals and plastics. Then it is desirable to be plastic.

 It is also necessary to select plastics that can withstand the properties of kits, such as chemical resistance, non-elution, and sterilization resistance. Further, a plastic to which a lubricating component is chemically bonded may be used.

 In addition, not only one intermediate slide valve in the kit preparation of the present invention, but also a required number corresponding to the number of drugs required to be injected in one injection operation is used. (Accordingly, the above-mentioned end point on the syringe needle side is the final point at which the intermediate slide valve can move, and the position may be defined not only by the bottom of the syringe cylinder but also by other intermediate slide valves. is there). At this time, the liquid passage forming means must have a number corresponding to the number of intermediate sliding valves used at that time.

 As the material of the syringe used in the present invention, those commonly used, that is, glass, polyolefin-based polymers such as polypropylene and amorphous polyolefin, and the like can be adopted. Of these, plastic materials are preferred because they can be easily treated as medical waste, but they are compatible with the sterilization conditions of currently used autocrepes, are low in cost, and have stability. Considering such factors, it is desirable to use a glass syringe.

 [Best Mode for Carrying Out the Invention]

Hereinafter, the shape of the intermediate sliding valve used in the present invention will be specifically described with reference to the drawings. I do.

 FIGS. 1 (a) and 1 (b) show an annular lip h1 (one in this example) which is in contact with the inner wall of the syringe cylinder and water-tightly divides the space on the syringe needle side and the space on the plunger operation side of the intermediate slide valve. A through hole h3 that bypasses the annular lip and communicates the space between the syringe needle side and the plunger operation side space, sealing means for sealing the through hole, and the injection valve allows the intermediate sliding valve to move the intermediate slide valve toward the syringe needle side. Rubber in which a lubricating component having an annular lip h1 and a through-hole h3 of an intermediate sliding valve Ha having a sealing release means for releasing the above-mentioned sealing when reaching the end point or near the end point is chemically bonded. It is a figure which shows the intermediate | middle sliding valve main-body part H1 consisting of. The intermediate sliding valve body H1 forms an intermediate sliding valve Ha according to the present invention together with a slider I1 described later. FIG. 1 (a) is a perspective view from the syringe needle side, and FIG. 1 (b) is a perspective view from the plunger operation side.

 In the drawing, reference numeral h2 denotes a plurality of holding portions that are in contact with the inner wall of the syringe barrel and hold the intermediate sliding valve so that the axis of the intermediate sliding valve coincides with the axis of the syringe barrel.

 FIGS. 1 (c) and 1 (d) are views showing a slider I1 in which an abutment portion i1 and a slide portion i2 are integrated, and are respectively a perspective view from the syringe needle side and a plunger operation side. It is the perspective view seen from. The length of the slider I 1 (the left and right length in the figure) is longer than the thickness of the intermediate sliding valve body H 1.

The length of the slider I 1 is longer than the thickness of the intermediate sliding valve body H 1, and the contact portion i 1 is connected to the syringe needle side of the intermediate sliding valve body H 1 (left in the figure). ) It protrudes forward, is housed in the through hole h3 of the intermediate sliding valve main body H1, and is slidable with respect to the intermediate sliding valve main body H1 toward the plunger operating side (right in the figure). The sliding portion # 2 has a front opening which opens into the space on the syringe needle side of the intermediate sliding valve. # 3, the side opening i provided on the surface of the sliding portion i2 which is in contact with the inner wall surface of the main body through hole h3. 4, and a liquid passage hole i5 communicating with the front opening i3 and the side opening i4 is provided, and the slide portion i2 is planned with respect to the intermediate sliding valve body H1. At the time of sealing (see FIG. 1 (e) (perspective view from the syringe needle side) and FIG. 1 (f) (perspective view from the plunger operation side)) before sliding to the jaw operation side, The side opening i4 is closed by the wall surface of the through hole h3 of the intermediate sliding valve body, and when the sliding part i2 slides toward the plunger operation side with respect to the intermediate sliding valve body H1 when opened ( In Fig. 1 (g) (perspective view from the syringe needle side) and Fig. 1 (h) (perspective view from the plunger operation side) reference), the side opening i4 is used for the drug on the plunger operation side. The medicine exposed on the plunger operation side can be supplied to the syringe needle side of the intermediate slide valve Ha from the front opening i3 through the liquid passage hole i5.

 In this example, the sealing means for sealing the through hole h3 is constituted by the side opening i4 and the wall surface of the intermediate sliding valve main body through hole h3. It can be seen that the seal release means for releasing the seal when reaching near the end point is constituted by the slider I1 in which the contact portion ί1 and the slide portion i2 are integrated.

 As described above, the intermediate sliding valve body H1 projects forward of the syringe needle toward the syringe needle, and the intermediate sliding valve advances toward the syringe needle toward the bottom of the syringe needle or forward of the intermediate sliding valve Ha toward the syringe needle. The sealing means is driven by an operation in which the contact portion i1 that contacts another intermediate slide valve and the contact portion ί1 move relative to the plunger operation side with respect to the intermediate slide valve main body Ha. Thus, it can be understood that the sealing means and the sealing release means are constituted by the slide portion i2 for releasing the sealing of the through hole h3 by the sealing means.

As described above, in this intermediate sliding valve Ha, since the slider I1 is housed in the through hole h3 so as to protrude outside the part, the residual liquid remaining in the through hole h3 (not injected) The amount of the chemical solution is limited to the internal volume of the liquid passage hole i5, and the remaining liquid amount is minimized by making the liquid passage hole i5 as narrow as possible in consideration of the properties of the chemical solution. It is possible. Also, since the slider I1 is pushed to the left in the figure by the pressure applied to the chemical solution on the plunger operation side of the intermediate sliding valve Ha, the area of the bottom is smaller than that of the injection cylinder inside cross-sectional area. It must be small enough to move slider I1 during operation.

 Here, FIG. 2 (a) is an enlarged view of the vicinity of the operation side of the intermediate slide valve Ha plunger in FIG. 1 (h).

 At this time, the second agent behind the intermediate slide valve Ha passes through the side opening i4 and the liquid passage hole i5 of the slide portion i2 of the slider I1, and from the front opening i3 (not shown), the intermediate slide valve. It is possible to move ahead of Ha. However, in the case of a normal slow injection operation, as shown in FIG. 2 (a), when the side opening i4 is partially exposed to the second agent, the pressure of the second liquid decreases, and At the moment, the sliding operation of the intermediate sliding valve body H1 to the right in the figure stops. As a result, the opening is kept small, and as a result, the pressure loss when the second liquid passes through the side opening i4 is large, so that the plunger operation becomes stiff and the subsequent injection operation becomes relatively difficult. Become.

 In order to solve such a problem, the side opening i4 on the side surface of the slide portion i2 is enlarged in the circumferential direction of the slide portion 'i2 (two arrow directions in Fig. 2 (a)). The part i6 (see FIG. 2 (b)) may be provided on the side surface of the slide part i2. In this example, the expanding portion 6 is groove-shaped and makes a full circumference in the circumferential direction on the side surface of the slide portion i2. However, it is not always necessary to make one full rotation, and the pressure loss when the second agent passes is sufficient. It is sufficient if the length is small enough.

By providing a non-return portion for preventing the slide portion i 2 from moving forward from the closed position to the syringe needle side with respect to the intermediate slide valve Ha (intermediate slide valve body H 1), This can be the case when the cap is filled with a vacuum for filling chemicals, when the operator operates the plunger to the suction side, or when abnormal vibrations occur during storage or transportation, or when the environment is sudden (such as temperature). The chemical solution before and after the intermediate slide valve was mixed even if Or the risk of inoperability can be prevented.

 Fig. 2 shows an example in which a check part i7 having an outer diameter larger than the inner diameter of the through hole h3 of the intermediate sliding valve body is provided at the plunger operation side end of the slide part i2 as such a check part. This is shown in (c). In this example, the check portion i7 is provided on the intermediate sliding valve main body H1 at the time of sealing before the sliding portion i2 slides toward the plunger operating side with respect to the intermediate sliding valve main body H1. It is designed to be completely stored in the check section storage section h4.

 FIG. 2 (d) shows an example of a slide portion having a check portion i7 'of another shape. The check part i 7 ′ is provided on the plunger operation side with a part that is one step thicker than the check part i 7 in FIG. 2 (c), and the enlarged part is stored in the check part storage part h 4. However, as a result, it is possible to more reliably prevent the slider from going backward. Here, another example of the shape of the slider will be described. The same members will be described with the same reference numerals.

 The slider I2 shown in FIG. 3 (a) has a groove-shaped widened portion i6 that goes around the circumferential direction near the side opening i4.

 The slider I3 shown in FIG. 3 (b) has a groove-shaped widened portion i6 that goes around the circumference in the vicinity of the side surface opening ί4. There is also a similar groove i8, and as a result, the contact area between the slider I3 and the inner wall of the through hole of the intermediate sliding valve body is reduced, and the slidability of the slider I3 is improved. . The slider I4 in FIG. 3 (c) is another example in which the slidability is improved similarly to the slider I3.

FIGS. 4 (a) to (d) show other examples I5 to I8 of the slider. In these, the liquid passage hole # 10 communicating with the front opening i9 and the side opening i11 is constituted by the slide portion and the inner wall surface of the through hole of the intermediate sliding valve body (not shown). These have a front opening i11 opening into the space on the syringe needle side of the intermediate sliding valve, and a fluid passage i10 communicating the front opening i11 and the side opening i9 with the slide part i2. This is an example provided between a sliding valve body (not shown) and sliders I7 and I8 are examples in which slidability is further improved at the same time. FIG. 5 (a) shows a slider I9 having a check portion i7. FIG. 5 (b) shows a sliding valve main body HI (same as that used in FIG. 1) which constitutes the intermediate sliding valve Hb (see FIG. 5 (c)) together with the slider I9.

 FIG. 6 (a) also shows a slider I 10 having a check portion iΊ. FIG. 6 (b) shows the sliding valve main body H 1 ′ that constitutes the intermediate sliding valve H c (see FIG. 6 (c)) together with the slider I 10. The through hole h 3 ′ of the sliding valve main body H 1 ′ is provided with a large diameter portion that can accommodate the check portion i 7.

 As shown in FIG. 7, a slider I11 having a tapered check portion i7 may be used.

 FIG. 8 shows an example of a two-lip intermediate sliding valve.

 The two-lip type intermediate sliding valve does not allow the chemical liquid to enter between these lips, so that the chemical liquid is not wasted and the filled chemical liquid can be used more effectively.

Fig. 8 (a) shows the sliding valve body H4 of the two-lip intermediate sliding valve. In this example, two annular lips h1 are provided. FIG. 8 (b) shows the slider I12 forming the intermediate sliding valve Hd together with the sliding valve body H4. The slider I 1 2 is formed by an abutment portion i 1 and a slide portion i 2, and the side surface opening of the slide portion i 2 along with the expansion portion i 6 is provided on a surface of the intermediate slide valve body through hole h 3 which is in contact with the inner wall surface. 4 and a front opening i3 opening in the space on the syringe needle side of the intermediate sliding valve, and a fluid passage i5 communicating with the front opening i3 and the side opening i4 have a slide portion i. It is provided inside and closes before the slider I 12 slides toward the plunger operating side with respect to the intermediate sliding valve body H 4 (the state shown in FIG. 8 (c)). The side opening i 4 is closed by the wall of the through hole h 3 of the intermediate sliding valve body, and the slider I 12 slides toward the plunger operation side with respect to the intermediate sliding valve body H 4 when opened (No. 8). In the state shown in Fig. (D), the side opening i4 is exposed to the medicine on the plunger operation side, and the medicine on the plunger operation side is injected into the intermediate slide valve through the above-mentioned liquid passage i5. It can be supplied to the cylinder needle side. The slider I 12 is provided with a check part i 7.

 The operation method of an example of a kit preparation using such a serial sequential dispensing syringe having the intermediate sliding valve Hd will be specifically described with reference to FIGS. 9 (a) to 9 (d). ) Middle code 1 indicates a glass syringe (one-piece, normal shape) which is easy to sterilize and mass-produced at low cost.

 For example, lidocaine hydrochloride (infiltration anesthetic) liquid is filled as a first agent 5 in a watertight space formed by the injection cylinder 1 and the intermediate sliding valve Hd of this kit preparation. Further, for example, sodium hyaluronate solution is filled as the second agent 6 in a watertight space formed by the injection cylinder 1, the intermediate sliding valve Hd, and the plunger sliding valve 2.

 The injection needle connection portion 1a of the injection cylinder 1 is sealed by a cap 4 made of resin.

 Prior to use of such a kit preparation, the cap 4 is removed as shown in FIG. 9 (b), and the injection needle 7 is attached to the injection needle connection portion 1a of the injection cylinder 1.

 At this time, by operating the plunger operating section 2a with the injection needle side up, even if there is air that has entered the first agent 5 when the needle is attached, it can be completely removed. If it is particularly necessary to reduce the injection amount of the first agent 5, the plunger operation section 2a is operated at this stage to reduce the injection amount.

Next, the injection needle 7 is pierced into the required injection site, and then the plunger operation section 2a is moved to the syringe needle side to inject the first agent 5. The state immediately before the injection of the first agent 5 is completed when the intermediate sliding valve Hd moves within the syringe cylinder 1 and reaches the syringe needle side end point and the injection of the second agent 6 is shown in FIG. 9 (c). Show. At this time, the slider I 12 of the intermediate sliding valve Hd, which was initially in the closed state, slides to the open state shown in FIG. 9 (c), so that the rear of the intermediate sliding valve Hd The second agent 6 can move to the front of the intermediate sliding valve Hd from the front opening i3 through the side opening i4 and the liquid passage hole i5 of the slider I11.

When the operation of the plunger 2a is continued following the above, the side opening i4, the liquid passage hole ί5, and the front opening! 3 (Refer to Fig. 8 ( ₃ )-( _{ ;)), the second agent 6 behind the intermediate sliding valve Hd reaches the needle 7, and is injected. Finally, as shown in Fig. 9 (d). The injection is completed as shown.

 At this time, the plunger sliding valve 2 has the sliding portion i 2 of the slider I 12, which slides toward the plunger operating side with respect to the intermediate sliding valve body H 1, and the amount of protrusion of the sliding portion when opened (the 9 (See (d) in Fig. 9), the recess 2b is provided, so that the intermediate sliding valve main body H4 and the plunger sliding valve 2 are in close contact with each other. There is almost no residual liquid between 1 and the plunger sliding valve 2, and almost all of the second liquid can be injected.

 Here, in order to be able to inject the second liquid without waste, the side opening i4, the liquid passage hole i5, and the front opening i3 need to be sufficiently thin, but the viscosity of the second liquid is high. In such a case, the pressure loss will be large, so it is necessary to design in consideration of the properties of the drug solution so as not to impede the injection operation.

 When the injection amount of the second agent 6 needs to be particularly reduced, the injection operation may be terminated in a state where the second agent 6 remains in the syringe 1.

 As described above, by using the intermediate sliding valve according to the present invention, the medicinal solution can be sequentially and reliably injected even if a conventional injection cylinder without special processing is used.

Kit preparation that can be injected sequentially without mixing three or more drugs Syringe (one first intermediate sliding valve located closest to the syringe needle inside the syringe barrel, and one or more second intermediate sliding valves located closer to the plunger operating side than the first intermediate sliding valve) An example of a syringe having the following will be described with reference to FIG.

 The intermediate sliding valve Hd shown in Fig. 10 (a) is the same as the one used in Fig. 9 ^: the intermediate sliding valve located closest to the syringe needle (hereinafter referred to as "the first intermediate sliding valve"). In other words, the intermediate sliding valve of the present invention, which enables sequential injection without mixing two agents, allows sequential injection without mixing three or more liquids without changing the design. It can be used as the first intermediate sliding valve in a syringe, and the intermediate sliding valve H d ′ (hereinafter referred to as “second intermediate sliding valve”) shown in FIG. This is an intermediate sliding valve located closer to the plunger operation side than the sliding valve. The intermediate sliding valve Hd and the intermediate sliding valve Hd 'are arranged in a syringe 1 (a normal, integrally formed low-cost syringe) as shown in FIG. 10 (c). ing.

 Here, in the present invention, in the case of a syringe having a plurality of intermediate sliding valves, the intermediate sliding valve disposed closest to the syringe needle such as the intermediate sliding valve Hd is referred to as a “first intermediate sliding valve”. In addition, all of the intermediate sliding valves, such as the intermediate sliding valve Hd ', which are disposed on the plunger operation side of the first intermediate sliding valve are collectively referred to as "second intermediate sliding valve". I say. In the following, an example will be described in which three liquids can be sequentially injected without mixing.However, a syringe capable of sequentially injecting without mixing four or more liquids can be obtained by increasing the number of the second intermediate sliding valves. It can be achieved similarly.

The second intermediate sliding valve H d ′ is in contact with the inner wall of the injection cylinder and bypasses the annular lip h 1 and the annular lip h 1 which watertightly divides the injection needle side space and the plunger operation side space of the intermediate sliding valve. A through hole h 3 ′ that communicates the space between the syringe needle side and the plunger operation side, sealing means for sealing the through hole, and the intermediate sliding valve H d ′ at the injection needle side end point or near the end point in the injection operation Release the above seal when the seal is reached An intermediate sliding valve for a syringe having a releasing means, wherein the annular lip h is in contact with the inner wall of the syringe cylinder 1 and water-tightly divides the space on the syringe needle side and the space on the plunger operation side of the second intermediate sliding valve hd '. 1, a through-hole h3 'that bypasses the annular lip h1 and communicates the space between the syringe needle side and the plunger operation side; sealing means for sealing the through-hole h3'; A seal releasing means for releasing the seal when the valve H d ′ reaches the end point of the injection needle on one needle side or in the vicinity of the end point, and the second intermediate sliding valve has the annular lip h 1 and The intermediate sliding valve main body H 4 ′ having a through hole h 3 ′, the contact part i 1 and the sliding part i 2, and the sealing means and the sealing releasing means are directed toward the syringe needle of the intermediate sliding valve. A contact portion i 1 that contacts another intermediate slide valve in front of the intermediate slide valve on the syringe needle side with the advance of the intermediate slide valve; The sealing means is driven by the operation in which the contact part ί1 moves relatively to the plunger operation side with respect to the intermediate sliding valve body part '4', and the sealing of the through hole h3 'by the sealing means is released. This is a second intermediate sliding valve for a syringe comprising a sliding portion i 2.

Further, in the second intermediate sliding valve Hd ′, the contact portion i 1 ′ and the sliding portion i 2 ′ are integrated to form a slider I 1 2 ′, and the slider I 1 2 ′ is The sliding valve body H 4 ′ is housed in the through hole h 3 ′ and is slidable to the plunger operating side with respect to the intermediate sliding valve body H 4 ′. Intermediate sliding valve main body H 4 ′ Through hole h 3 ′ Side opening i 4 ′ is provided on the surface in contact with the inner wall surface, and front opening i 3 that opens into the syringe needle side space of intermediate sliding valve H d ′ And a liquid passage i 5 ′ communicating with the front opening i 3 ′ and the side opening i 4 ′ is provided in the slide portion i 2 ′. Further, the slider I 1 2 ′ is connected to the intermediate slide valve main body H At the time of sealing before sliding to the plunger operation side with respect to 4 ', the side opening ί4' is sealed by the intermediate sliding valve body 本体 4 'through hole h3' wall. When the slider I 1 2 ′ slides toward the plunger operation side with respect to the intermediate sliding valve main body H 4 ′, the side opening i 4 ′ is exposed to the drug on the plunger operation side, and This is a second intermediate sliding valve for a syringe that allows a drug on the plunger operation side to be supplied to the syringe needle side of the intermediate sliding valve Hd 'through the liquid passage hole 5'.

 In this example, the length of the slider I 12, is almost equal to the thickness of the intermediate sliding valve main body H 4 ′, and it is located in front of the through hole h 3 ′ of the intermediate sliding valve main body H 4 ′. A recess h5 having a large outer diameter of the slider of the intermediate sliding valve and having a size corresponding to a check portion protruding from the intermediate sliding valve toward the plunger operating side is provided. The syringe shown in FIG. 10 (c) provided with one such first intermediate sliding valve Hd and one second intermediate sliding valve Hd ′ is the same as the syringe shown in FIG. It can be handled like a syringe.

 Fig. 10 (c) shows a state in which the injection needle 7 is attached, and Fig. 10 (d) shows a state in which the injection of the first liquid has been completed (the slider I12 has already been slid to the plunger operation side when opened). Figure 10 (e) shows the state when the injection of the second liquid has been completed (when the slider I12 'abuts on the slider I12 and then slides to the plunger operation side, when opened) The slide amount of the slide I12 'of the second intermediate slide valve Hd' to the plunger side is the slide amount of the slide I12 of the first intermediate slide valve Hd to the plunger side. FIG. 10 (f) shows a state in which all injection operations have been completed. At this time, the plunger sliding valve 2 and the second intermediate sliding valve Hd 'have a concave portion 2b corresponding to the plunger side slide amount of the slide I1 2' of the second intermediate sliding valve Hd '. Since there is no gap between the sliding valve H d ′, there is almost no residual drug solution in the syringe.

As described above, the total amount of liquid that can be injected decreases with an increase in the number of intermediate slide valves used. The number of intermediate sliding valves to be used is two). The first liquid is 20 mI of a water-soluble vitamin, the second liquid is 2 mI of a fat-soluble vitamin, and the third liquid is 20 mI of glucose injection. Thus, a sufficient amount of liquid for injection of a general drug is secured. Further, an annular lip which is in contact with the inner wall of the injection cylinder and divides the injection needle side space of the intermediate sliding valve and the plunger operation side space in a watertight manner, bypasses the annular lip and communicates the injection needle side space with the plunger operation side space. For a syringe, comprising: a through-hole that seals the through-hole; sealing means for sealing the through-hole; and sealing release means for releasing the sealing when the intermediate sliding valve reaches the syringe needle side end point or near the end point during injection operation. Another example He of the intermediate sliding valve is shown in Fig. 11 (a).

 In this example, a through-hole h3 "is provided at the center of the sliding valve main body H5, bypassing the annular lip, and communicating the space on the syringe barrel needle side with the space on the plunger operation side. It consists of a part with a small inner diameter on the cylinder needle side (small diameter part) h3a〃 and a thick part on the plunger operation side (large diameter part) h3b ". These small diameter part h3a" and large diameter part h3 Sealing valve i 1 2 (a material harder than the material constituting the sliding valve body H5: resin in this example) as a sealing means on the large diameter part h3b "side of the boundary (step) of b〃 Are fitted due to the elastomeric properties of the material constituting the sliding valve body H5 (rubber with a lubricating component chemically bonded in this example).

 In the small-diameter portion h3a, a slider I13 (see FIG. 11 (b)) is housed as a sealing release means with its abutting portion i1 protruding toward the syringe needle. A valve driving rod i2a is provided protrudingly on the plunger operation side of the slide part i2 of the slider I13, and the entire length of the slider I13 is longer than the small diameter part h3a ". The valve driving rod i 2 a is configured to abut on a portion relatively close to the end, not on the center of the sealing valve 中央 12.

When such an intermediate slide valve He reaches the vicinity of the end point of the syringe needle by the injection operation and is further driven to the syringe needle side, the contact part i 1 is connected to another intermediate slide valve or the bottom of the syringe cylinder. The sliding valve body is driven toward the plunger operating side relative to the sliding valve body H5. As a result, the valve driving rod i 2 a on the plunger operation side of the slider I 13 pushes the close valve i 12, and the seal valve i 12 rotates, resulting in the result shown in FIG. 11 (c). As a result, the sealing by the sealing valve i 12 between the injection needle side space of the intermediate sliding valve and the plunger operating side space is released, and the chemical liquid on the plunger operating side of the intermediate sliding valve He is transferred to the slider I 13. It becomes possible to move to the syringe needle side through the through hole i 13. As described above, the sealing valve i 1 2 is fitted on the large-diameter portion h 3 b ”at the boundary (step) between the small-diameter portion h 3 a” and the large-diameter portion h 3 b ”of the through hole h 3”. As long as it is not near the end point, there is no danger that the seal will be released even if the plunger is operated by injection, malfunction or shock.

 In the above example, the shape of the slider I 13 can be freely changed as long as the above operation is possible, for example, so as to reduce the remaining liquid amount.

 [The invention's effect]

The syringe for kit preparation of the present invention has an intermediate slide valve inside the injection cylinder, wherein the intermediate slide valve is used for a syringe-type kit preparation in which at least a plunger operation side is filled with a drug solution. An annular lip that contacts the inner wall of the injection cylinder and divides the injection needle side space and the plunger operation side space of the intermediate sliding valve in a watertight manner; and bypasses the annular lip to communicate the injection needle side space and the plunger operation side space. And a sealing means for closing the through hole, and sealing means for releasing the sealing when the intermediate sliding valve reaches the syringe needle side end point or near the end point during the injection operation. Thus, the present invention is a syringe for a kit preparation having a simple and easy-to-manufacture structure capable of reliably and sequentially injecting a medicinal solution while using a conventional injection syringe having a conventional shape. The intermediate slide valve for a syringe according to the present invention has an intermediate slide valve inside the syringe cylinder, and the intermediate slide valve for a syringe used for a syringe-type kit preparation in which a chemical solution is filled at least on the plunger operation side of the intermediate slide valve. An annular lip which is in contact with the inner wall of the injection cylinder and which divides the injection needle side space and the plunger operation side space of the intermediate sliding valve in a watertight manner; and which bypasses the annular lip and connects the injection needle side space and the plunger operation side space. A sealing means for sealing the through-hole, and the intermediate slide valve being connected to the syringe needle at the injection needle. A simple and easy-to-manufacture structure capable of reliably injecting the chemical solution sequentially while using a conventional normal-shaped injection cylinder by using a structure having a seal releasing means for releasing the above-mentioned seal when reaching the point or the vicinity of the end point. Is an intermediate sliding valve for a syringe.

 The kit preparation of the present invention has an intermediate slide valve inside the injection cylinder, and a syringe-type kit preparation in which at least the plunger operation side of the intermediate slide valve is filled with a drug solution, wherein the intermediate slide valve is: An annular lip which is in contact with the inner wall of the injection cylinder and divides the injection needle side space of the intermediate slide valve and the plunger operation side space in a watertight manner; a through hole which bypasses the annular lip and communicates the injection needle side space and the plunger operation side space Conventionally, there are provided a sealing means for sealing the hole and the through hole, and a sealing releasing means for releasing the sealing when the intermediate slide valve reaches the injection needle side end point or near the end point during the injection operation. This is a syringe-type kit preparation having a simple and easy-to-manufacture structure capable of injecting a drug solution in a sequential manner without fail while using the normal-shaped injection cylinder.

 [Brief description of drawings]

FIG. 1 is a model diagram showing an example of an intermediate sliding valve Ha according to the present invention.

 (a) It is the perspective view which looked at the intermediate | middle sliding valve main-body part H1 from the injection needle side.

 (b) It is the perspective view which looked at the intermediate sliding valve main part HI from the plunger operation side.

 (c) A perspective view of the slider I1 as viewed from the syringe needle side.

 (d) It is the perspective view which looked at the slider I1 from the plunger operation side.

 (e) Slider I1 projects into the through hole h3 of the intermediate sliding valve main body H1 with the contact part i1 protruding toward the syringe needle side and housed to form the intermediate sliding valve Ha. It is the perspective view seen from the cylindrical needle side.

 (f) The plunger is operated in a state where the slider I1 is inserted into the through hole h3 of the intermediate sliding valve main body HI so that the contact portion i1 protrudes toward the injection needle and is housed to form the intermediate sliding valve Ha. It is the perspective view seen from the side.

(g) The contact part i1 contacts another intermediate sliding valve or the bottom of the syringe barrel, FIG. 4 is a perspective view of the state in which the da I 1 has been slid relatively to the plunger operation side with respect to the intermediate sliding valve body H 1 as viewed from the syringe needle side.

 (h) A state in which the contact part i1 contacts another intermediate sliding valve or the bottom of the syringe barrel, and the slider I1 slides relatively to the plunger operating side with respect to the intermediate sliding valve body H1. It is the perspective view seen from the plunger operation side.

Fig. 2

 (a) FIG. 1 (h) is an enlarged view of the vicinity of the intermediate slide valve Ha plunger operation side in FIG. 1 (h).

 (b) Enlarge the side opening i4 on the side surface of the slide part i2 in the circumferential direction of the slide part i2 (two arrow directions in Fig. 2 (a)). It is a figure which shows the example provided in the side of.

 (c) It is a figure showing the state where the check part was provided.

 (d) is a diagram showing a state in which check members having different shapes are provided.

Fig. 3

 (a)-(c) It is a figure which shows the slider of another shape.

Fig. 4

 (a)-(d) is a figure which shows the slider of another shape.

Fig. 5

 (a) It is a figure which shows the slider I9 of another shape.

 (b) is a view showing a sliding valve body H2.

 (c) is a view showing an intermediate sliding valve Hb according to the present invention.

Fig. 6

 (a) It is a figure which shows the slider I10 of another shape.

 (b) It is a figure which shows the sliding valve main-body part H3.

(c) is a view showing an intermediate sliding valve Hc according to the present invention. Fig. 7

 FIG. 11 is a view showing a slider I 11 of another shape.

Fig. 8

 (a) is a view showing a sliding valve main body portion H4 constituting an intermediate sliding valve Hd according to the present invention together with a slider I12.

 FIG. 3B is a view showing a slider I 12.

 (c) is a view showing a state of the intermediate sliding valve Hd in a closed state before the slider I12 slides toward the plunger operation side with respect to the intermediate sliding valve body.

(d) is a view showing the state of the intermediate sliding valve Hd when the slider I12 is opened when the slider I12 slides toward the plunger operation side with respect to the intermediate sliding valve body.

Fig. 9

 (a) is a view showing a state before the start of use of a syringe-type kit preparation using the intermediate sliding valve Hd according to the present invention.

 (b) A diagram showing a state in which a syringe needle has been attached before the start of use of a syringe-type kit preparation using the intermediate sliding valve Hd according to the present invention.

 (c) A diagram showing a state immediately before the injection operation of the first liquid is completed and the injection of the second liquid is started during use of the syringe-type kit preparation using the intermediate sliding valve Hd according to the present invention. is there.

 (d) is a diagram showing a state where injection by a syringe-type kit preparation using the intermediate sliding valve Hd according to the present invention has been completed.

FIG. 10 is an example of a syringe that can be sequentially injected without mixing the three liquids.

 (a) is a view showing a first intermediate sliding valve Hd according to the present invention.

 (b) is a view showing a second intermediate sliding valve H d 'according to the present invention.

 (c) is a view showing a syringe that can be sequentially injected without mixing the three liquids.

(d) is a diagram showing a state in which the injection of the first liquid has been completed. (e) is a diagram showing a state in which the injection of the second liquid has been completed.

 (f) It is a figure showing the state where all injection operations were completed.

Fig. 11

 (a) is a diagram showing an intermediate sliding valve He in which the sealing valve and the slider are separate members.

 (b) It is a perspective view which shows the slider of the intermediate sliding valve of (a).

 (c) It is a figure which shows operation | movement of the intermediate sliding valve of (a).

Fig. 12

 (a) is a diagram showing a state before starting use of a syringe-type kit preparation according to a conventional technique.

 (b) It is sectional drawing in LL of (a).

 (c) is a diagram showing a state in which an injection needle has been attached just before starting use of a syringe-type kit preparation according to a conventional technique.

Fig. 13

 (a) is a diagram showing a state immediately before the injection operation of the first liquid is completed and the injection of the second liquid is started during use of the syringe-type kit preparation according to the conventional technique.

 (b) is a diagram showing a state in which the injection with the syringe-type kit preparation according to the prior art has been completed.

Fig. 14

 (a) is a diagram showing another example of a syringe-type kit preparation according to the prior art.

(b) A view showing a state immediately before the end of the injection of the first liquid in (a).

Claims

The scope of the claims

1. In a syringe used for a syringe-type kit formulation having an intermediate slide valve inside a syringe cylinder and at least a plunger operation side of the intermediate slide valve being filled with a drug solution, the intermediate slide valve is: An annular lip which is in contact with the inner wall of the injection cylinder and divides the injection needle side space of the intermediate slide valve and the plunger operation side space in a watertight manner; a through hole which bypasses the annular lip and communicates the injection needle side space and the plunger operation side space. A sealing means for sealing the hole and the through-hole, and a sealing releasing means for releasing the sealing when the intermediate slide valve reaches the injection needle side end point or near the end point by an injection operation. Syringe for kit preparation.

 2. The intermediate sliding valve comprises an intermediate sliding valve body having an annular lip and a through hole, an abutting portion, and a sliding portion, and the sealing means and the sealing release means are used for injection of the intermediate sliding valve body. A contact portion that projects forward in the cylinder needle side and abuts on the bottom of the syringe needle side or another intermediate slide valve in front of the intermediate slide valve on the syringe needle side as the intermediate sliding valve advances toward the syringe needle side; The sliding part is configured to drive the sealing means by an operation of moving the part relatively to the plunger operation side with respect to the intermediate sliding valve body part, and to release the sealing of the through hole by the sealing means. 2. The syringe for kit preparation according to claim 1, wherein:

3. The contact portion and the slide portion are integrally formed to form a slider, and the slider protrudes the contact portion forward of the intermediate slide valve body toward the syringe needle, and forms a slider. A side opening is provided in the through-hole and slidable toward the plunger operation side with respect to the intermediate sliding valve main body, and a surface of the sliding portion in contact with the inner wall surface of the intermediate sliding valve main body through-hole. The front opening opening in the space on the syringe needle side of the intermediate sliding valve and the fluid passage communicating with the front opening and the side opening have a slide portion, an intermediate sliding valve body portion, or an intermediate portion between the sliding portion and the sliding portion. Between the sliding valve body Further, at the time of sealing before the slider slides toward the plunger operation side with respect to the intermediate sliding valve body, the side opening is sealed by the inner wall surface of the intermediate sliding valve body through hole, and the slider is provided with the intermediate sliding valve. When the slide is opened to the plunger operation side with respect to the valve operating body, the side opening is exposed to the medicine on the plunger operation side, and the medicine on the plunger operation side is injected into the intermediate slide valve through the above-mentioned liquid passage hole. 3. The syringe for kit preparation according to claim 2, wherein the syringe can be supplied to the cylindrical needle side.

 4. The syringe for kit preparation according to claim 3, characterized in that it has an opening that enlarges a side opening of a side surface of the slide portion in a circumferential direction of the side surface of the slide portion.

 5. The kit according to claim 3, wherein the slider has a check portion for preventing the slider from moving forward from the closed position with respect to the injection needle relative to the intermediate slide valve. Formulation syringe.

 6. The plunger slide valve has a recess corresponding to the amount of protrusion of the slider from the intermediate slide valve body when the slider slides to the plunger operation side with respect to the intermediate slide valve body when opened. The syringe for kit preparation according to any one of claims 3 to 5, characterized in that:

 7. An intermediate slide valve for a syringe used for a syringe-type kit preparation having an intermediate slide valve in the interior of the injection cylinder, wherein at least the plunger operation side of the intermediate slide valve is filled with a drug solution. An annular lip which is in contact with the inner wall and divides the injection needle side space and the plunger operation side space of the intermediate sliding valve in a watertight manner; a through hole which bypasses the annular lip and communicates the injection needle side space and the plunger operation side space; A syringe having sealing means for sealing the through hole, and sealing releasing means for releasing the sealing when the intermediate slide valve reaches the end point on the syringe needle side or near the end point in the injection operation. Intermediate sliding valve.

8. The intermediate sliding valve comprises an intermediate sliding valve body having an annular lip and a through hole, an abutting portion, and a sliding portion, wherein the sealing means and the sealing releasing means are intermediate sliding valves. A contact portion that projects forward of the main body toward the syringe needle and contacts the bottom of the syringe needle or the other intermediate slide valve located forward of the intermediate slide valve on the syringe needle side as the intermediate slide valve advances toward the syringe needle. And a slide part for driving the resealing means to release the sealing of the through-hole by the sealing means by an operation of moving the corresponding contact part relatively to the plunger operation side with respect to the intermediate sliding valve body part. The intermediate slide valve for a syringe according to claim 7, wherein

 9. The contact portion and the slide portion form a slider to form a slider, and the slider protrudes the contact portion forward of the intermediate slide valve body toward the syringe needle, and forms the slider. The slide opening is slidable toward the plunger operation side with respect to the intermediate sliding valve main body, and a side opening is provided on a surface of the sliding portion which is in contact with the inner wall surface of the intermediate sliding valve main body through-hole. And a front opening that opens into the space on the syringe needle side of the intermediate sliding valve and a liquid passage that communicates with the front opening and the side opening have a slide portion, an intermediate sliding valve body portion, or a sliding portion. When the slider is closed before the slider slides toward the plunger operation side with respect to the intermediate sliding valve body, the side opening is provided between the intermediate sliding valve body and the intermediate sliding valve body. Sealed by inner wall surface, slider is medium When the sliding valve body slides to the plunger operation side when opened, the side opening exposes the medicine on the plunger operation side, and the medicine on the plunger operation side passes through the above-mentioned liquid passage hole and the intermediate slide valve is opened. 9. The intermediate slide valve for a syringe according to claim 8, wherein the intermediate slide valve can be supplied to a syringe needle side.

10. The intermediate sliding valve for a syringe according to claim 9, further comprising an expanding portion for expanding a side opening of a side surface of the slide portion in a circumferential direction of the side surface of the slide portion.

11. The claim according to claim 9 or claim 10, wherein the slider has a non-return portion for preventing the slider from moving forward with respect to the injection needle relative to the intermediate slide valve from a position at the time of sealing. Intermediate sliding valve for syringes.

1 2. At least the area near the annular lip is rubber with a lubricating component chemically bonded, or The intermediate slide valve for a syringe according to any one of claims 7 to 11, wherein the lubricating component is made of a chemically bonded plastic.

1 3. In a syringe-type kit preparation having an intermediate slide valve inside the syringe barrel and filling at least the plunger operation side of the intermediate slide valve with the medicinal solution, the intermediate slide valve contacts the inner wall of the syringe cylinder. An annular lip for watertightly dividing the space between the syringe needle and the plunger operation side of the intermediate sliding valve; a through-hole that bypasses the annular lip and communicates the space between the syringe needle and the plunger operation side; A sealing means for closing the through hole; and a sealing release means for releasing the sealing when the intermediate sliding valve reaches the injection needle side end point or near the end point by an injection operation. Kit formulation.

14. The intermediate sliding valve comprises an intermediate sliding valve body having an annular lip and a through hole, an abutting portion, and a sliding portion, wherein the sealing means and the sealing release means are provided on the intermediate sliding valve body. A contact portion that projects forward in the syringe needle side and abuts on the bottom of the syringe needle side or another intermediate sliding valve in front of the intermediate slide valve on the syringe needle side as the intermediate slide valve advances toward the syringe needle side. A sliding part for driving the resealing means by an operation of moving the corresponding contact part relatively to the plunger operation side with respect to the intermediate sliding valve main body part to release the sealing of the through hole by the sealing means. 14. The kit preparation according to claim 13, comprising:

15. The contact portion and the slide portion are integrally formed to form a slider, and the slider projects the contact portion forward of the intermediate slide valve body portion toward the syringe barrel needle side to form the slider. A side opening is provided in a surface of the slide portion which is slidable toward the plunger operation side with respect to the intermediate sliding valve main body, and which is in contact with the inner wall surface of the intermediate sliding valve main body through-hole. And a front opening opening into the space on the syringe needle side of the intermediate sliding valve and a fluid passage communicating with the front opening and the side opening are provided with a slide portion, an intermediate sliding valve body portion, or a slide. Between the sliding part and the intermediate sliding valve body, and the slider is located on the plunger operating side with respect to the intermediate sliding valve body. When the slider is closed before sliding, the side opening is closed by the inner wall surface of the through hole of the intermediate sliding valve body, and when the slider is opened toward the plunger operation side with respect to the intermediate sliding valve body, the side opening is opened. 15. The medical device according to claim 14, wherein the medicine is exposed to the plunger operation side medicine, and the medicine on the plunger operation side can be supplied to the injection needle side of the intermediate sliding valve through the liquid passage hole. Kit formulation.

16. The kit preparation according to claim 15, further comprising an expanding portion for expanding a side opening of a side surface of the slide portion in a circumferential direction of the side surface of the slide portion.

 17. The slider according to claim 15 or claim 16, wherein the slider has a check portion for preventing the slider from moving forward with respect to the injection needle relative to the intermediate slide valve from a position at the time of sealing. Kit formulation.

 18. The plunger slide valve has a recess corresponding to the amount of protrusion of the intermediate slide valve body when the slider slides to the plunger operation side with respect to the intermediate slide valve body when opened. The kit preparation according to any one of claims 15 to 17, characterized in that:

1 9. One first intermediate sliding valve that is located closest to the syringe needle inside the syringe barrel, and one or more second intermediate sliding valve that is located closer to the plunger operating side than the first intermediate sliding valve A second intermediate sliding valve for use in a syringe having: a ring-shaped lip which is in contact with the inner wall of the syringe cylinder and water-tightly divides the space on the syringe needle side and the space on the plunger operation side of the second intermediate sliding valve; A through hole that bypasses the lip and communicates between the syringe needle side space and the plunger operation side space, sealing means for sealing the through hole, and the intermediate sliding valve reaches the syringe needle side end point or near the end point during injection operation Sealing release means for releasing the above-mentioned sealing when opened, and the second intermediate sliding valve comprises an intermediate sliding valve main body having the annular lip and a through hole, a contact portion, and a sliding portion. The sealing means and the sealing release means are the injection needle of the intermediate sliding valve. Abutment portion abutting the other intermediate sliding valve on the injection tube needle side in front of the intermediate sliding valve according to progression to, abutting portion intermediate For a syringe, comprising: a sliding portion for driving a resealing means by an operation of moving relatively to a plunger operation side with respect to a sliding valve body, and releasing the sealing of the through hole by the sealing means. 2nd intermediate sliding valve.

 20. The contact portion and the slide portion form a slider to form a slider, and the slider is housed in the through hole of the intermediate slide valve body and is opposed to the intermediate slide valve body. A side opening is provided on a surface of the slide portion which is in contact with the inner wall surface of the through hole of the intermediate sliding valve body portion, and opens into a space on the syringe needle side of the intermediate sliding valve. A front opening and a liquid passage communicating with the front opening and the side opening are provided in the slide portion, the intermediate slide valve body portion, or between the slide portion and the intermediate slide valve body portion, and further, the slider is provided. At the time of sealing before sliding to the plunger operation side with respect to the intermediate sliding valve main body, the side opening is sealed by the inner wall surface of the intermediate sliding valve main body through-hole, and the slider faces the intermediate sliding valve main body. Slide to the plunger operating side When opened, the side opening is exposed to the medicine on the plunger operation side, and the medicine on the plunger operation side can be supplied to the syringe needle side of the intermediate slide valve through the liquid passage hole. The second intermediate sliding valve for a syringe according to claim 19, wherein