WO2001047587A1

WO2001047587A1 - Slide valve for syringes, and plunger for slide valve-equipped syringes

Info

Publication number: WO2001047587A1
Application number: PCT/JP2000/009291
Authority: WO
Inventors: Tetsuro Higashikawa
Original assignee: Medical Information Services, Inc.
Priority date: 1999-12-27
Filing date: 2000-12-27
Publication date: 2001-07-05

Abstract

A substantially columnar slide valve for syringes, wherein one of the two parts, an annular lip contacting the inner wall surface of an injection barrel to water-tightly divide spaces before and after the slide valve and a holder contacting the inner wall surface of the injection barrel to control the substantially columnar stem of the slide valve so that the stem coincides with the axis of the injection barrel, the annular lip or holder at the head in the direction of travel of the slide valve during injection is installed at some distance away from the end of the substantially columnar slide valve, the slide valve enabling smooth injecting operation .

Description

Specification

Sliding valve for syringe and plunger for syringe with sliding valve

[Technical field]

The present invention relates to a slide valve for a syringe, particularly a slide valve most suitable for a syringe-type kit preparation, and a plunger for a syringe with a slide valve having such a slide valve at the tip.

[Background technology]

Injectables need to be slowly introduced into the body in order to work safely and effectively, and therefore the sliding valve needs to move smoothly.

However, in the case of a serial sequential dispensing syringe that can sequentially inject a plurality of drugs without mixing, in addition to the usual sliding valve directly driven by the plunger, the front and rear spaces inside the injection cylinder Since one or more intermediate sliding valves that divide water-tightly are used, it is inevitable that the operational feeling of the re-injection operation becomes heavier than a normal syringe.

In addition, when a high viscosity solution such as a sodium hyaluronate solution is injected, even a normal syringe having only a normal sliding valve directly driven by a plunger has a great operational feeling.

If such a feeling of operation is heavy, injection into the body can not be carried out slowly, and the needle tip may deviate from necessary points (veins, joint cavities, etc.) during injection, and may cause severe pain to the patient. May cause unexpected problems.

The present invention provides a sliding valve for a syringe that slides extremely smoothly, and a plunger for a syringe with a sliding valve that has a sliding valve that slides extremely smoothly, which solves the above-mentioned problems of the prior art. That is the subject.

[Disclosure of the Invention]

As set forth in claim 1, the slide valve for a syringe according to the present invention is a substantially cylindrical slide valve for a syringe, wherein the annular lip contacts an inner wall of the syringe cylinder and divides a space before and after the slide valve into a watertight manner. , And so that the substantially cylindrical axis of the slide valve is in contact with the inner wall of the syringe barrel and coincides with the axis of the syringe barrel. Of the holding parts that are regulated, the annular lip or holding part at the top of the sliding valve traveling direction at the time of injection is provided at a distance from the end (leading end) of the substantially cylindrical sliding valve. This is a slide valve for injectors.

With this configuration, an annular lip or holding portion is provided at the end of a conventional sliding valve for a syringe, for example, a cylindrical sliding valve as shown in FIGS. 6 (a) and 6 (b). Eliminates the difficulty of sliding with a certain syringe slide valve.

This is because in a conventional sliding valve for a syringe, the annular lip was strongly pressed against the inner wall of the syringe cylinder due to the deformation generated when a force was applied during the operation of injection, and the slidability was significantly impaired. However, the above-described specific configuration of the present invention allows injection without impairing the slidability.

In addition, since the syringe operator may perform the suction operation, the annular lip or the holding part at the rearmost part in the traveling direction of the slide valve is also provided at a distance from the rear end of the substantially cylindrical slide valve. Is desirable.

In the slide valve for a syringe according to the present invention, as described in claim 2, the effect of the present invention is maximized if the slide valve is a syringe for a kit preparation having a plurality of slide valves in one injection cylinder. Be demonstrated.

Further, as described in claim 3, when the sliding valve for a syringe of the present invention is made of rubber in which a lubricating component is chemically bonded or plastic in which a lubricating component is chemically bonded, it is currently used as a lubricant. However, it is possible to perform extremely safe injection without desorption of lubricating components without using silicone oil, which is partly questioned for its safety. This effect is remarkable in the case of a kit product for a syringe having a long contact time between the chemical solution and the sliding valve portion.

The plunger for a syringe with a sliding valve according to the present invention is a plunger for a syringe with a sliding valve having a substantially cylindrical sliding valve portion at the tip of the plunger portion, as described in claim 4, wherein An annular lip that contacts and divides the space before and after the sliding valve portion in a watertight manner; And a ring-shaped lip or holding part at the head of the sliding valve in the direction of movement of the sliding valve during injection, of the holding part which is in contact with the inner wall of the syringe barrel and regulates the substantially cylindrical axis of the sliding valve part so as to coincide with the axis of the syringe barrel. Is provided at a distance from the end (front end) of the substantially cylindrical sliding valve, and a cylindrical hollow coaxial with the substantially cylindrical sliding valve is provided inside the sliding valve. A cylindrical tip is inserted into the plunger portion having a size smaller than the cylindrical hollow portion so as to leave an axial gap and / or a circumferential gap in the cylindrical hollow portion. The sliding valve portion is held by the plunger portion by the cylindrical tip portion, and the cylindrical valve inside the sliding valve portion is positioned from the position of the leading annular lip or the holding portion in the traveling direction of the sliding valve portion. The plunge for a syringe with a sliding valve, where the bottom of the hollow part at the tip side is located on the tip side in the sliding valve part traveling direction. It is.

According to such a configuration, the slidability can be further improved as compared with a case where only the structure of the sliding valve is improved. The effect is maximized with a plunger with a sliding valve for a syringe-type kit formulation having a plurality of sliding valves inside.

Further, as described in claim 6, the sliding valve portion is made of a rubber to which a lubricating component is chemically bonded or a plunger for a syringe with a sliding valve made of a plastic to which a lubricating component is chemically bonded, The excellent slidability can be improved, and a safe syringe can be obtained without using a silicone oil which is partially questioned for safety. This effect is remarkable in a kit formulation for a syringe in which the contact time between the drug solution and the sliding valve portion is long.

In the present invention, the annular lip is provided so as to protrude in the circumferential direction of a substantially cylindrical slide valve for a syringe, is in contact with the inner wall of the syringe barrel, and has the slide valve (“slide valve” and “slide valve”). The space before and after the “sliding valve” in conjunction with the “valve drive section” is divided into watertight (including airtight).

In the present invention, the annular lip is in contact with the inner wall of the syringe barrel, and the space before and after the sliding valve. Any shape can be used as long as it is divided into watertight.

The annular lip also functions as a holding portion that contacts the inner wall of the syringe barrel and regulates the substantially cylindrical axis of the slide valve so as to match the axis of the syringe barrel.

Further, in the present invention, the holding portion is an annular lip which is provided so as to protrude in a circumferential direction of a substantially cylindrical slide valve for a syringe, and is in contact with an inner wall of the syringe cylinder and has a substantially cylindrical shape. Is regulated so as to coincide with the axis of the syringe barrel.

In the present invention, the shape of the holding portion is not limited as long as the holding portion is in contact with the inner wall of the syringe cylinder and regulates the substantially cylindrical shaft of the slide valve so as to match the shaft of the syringe tube. For example, it includes a holding portion that is partially cut, but has a shape similar to that of an annular lip. In the present invention, the sliding valve must have at least one annular lip. Usually has two or more annular lips, or one annular lip and one or more retainers.

In the sliding valve for a syringe according to the present invention, the leading annular lip or holding portion in the sliding valve traveling direction is provided at a distance from an end (leading end) of the substantially cylindrical sliding valve. It is necessary.

This distance is at least 0.5 mm, preferably at least 1 mm, and more preferably at least 1.5 mm. Note that the end of the substantially cylindrical slide valve refers to the circumference of the end face of the slide valve in the traveling direction. Small end portions may be provided on this end face due to structural necessity. In such a case, the end portion is ignored. In addition, in some cases, this end face is formed into a very loose conical shape. In such a case, the circumference of the conical bottom face is considered to be the end of a substantially cylindrical sliding valve, and a ring is provided at a distance from this circumference. A lip or holding part is provided. In the sliding valve of the present invention, the leading annular lip or holding portion in the sliding valve traveling direction is provided at a distance from the end (leading end) of the substantially cylindrical sliding valve. As a result, the force that presses the annular lip and the holding portion of the sliding valve against the inner wall of the injection cylinder due to the deformation of the sliding valve due to the pressure generated when the plunger is operated becomes extremely large Can be prevented, so that a smooth injection operation can be performed.

In addition, since the syringe operator may perform the suction operation of the drug solution, etc., the annular lip or the holding part at the rear end of the slide valve in the direction of travel of the slide valve at the time of injection is also closer to the rear end of the substantially cylindrical slide valve. It is desirable to be provided at a distance.

Examples of the rubber in the present invention include nitrile rubber, hydrogenated nitrile rubber, ethylene-propylene-gen rubber, ethylene-propylene rubber, and butyl rubber. Examples of the plastic include polyester, polyamide, polypropylene, polyolefin, and polyurethane.

These are organic or inorganic substances such as plasticizers that may adversely affect the living body.

It must be suitable for pharmaceutical use without the risk of eluting harmful metals, etc. or containing them. In addition, it must be at least resistant to the drug of interest.

In the present invention, as the lubricating component, a synthetic oil-based lubricant is desirable. Such materials include, for example, hydrocarbon-based materials, polyglycol-based materials, silicone-based materials, 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 greatly affects lubricity, it is necessary to determine the amount by various studies.

As a method of chemical bonding, general methods such as ordinary amide bond and ester bond are used. The bonding may be carried out in stages, but a method in which a group which reacts with the crosslinking agent of the rubber'plastic is introduced into the lubricating component in advance, and the method is carried out simultaneously with the crosslinking.

In addition, when a poorly reactive lubricant such as a fluororesin (polytetrafluoroethylene or a copolymer of tetrafluoroethylene and another comonomer) is used as a lubricating component, an electrophilic reagent may be used. (Hindered phenols and Grignard reagents) can be added together with these lubricants at the time of molding to form a chemical bond simultaneously with the crosslinking reaction.

The size of the lubricant is preferably 10 m or more and 5 Om or less in diameter. The addition amount 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 rubber 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 a fluororesin or silicone-based lubricant is used as the lubricating component, the sliding valve moves very smoothly and the movement starts smoothly, so that injection into a predetermined location such as intravenous injection becomes easy. Needless to say, in addition, for example, in the case of kit preparations, the injection volume may be adjusted according to the patient instead of injecting the whole injection solution in the cylinder. This has the effect of making it extremely easy to inject. 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, it is necessary that the electrophile is compatible with the base rubber or plastic component and does not cause any obstacles. Such compounds include hindered phenols, for example, pentaerythritylate trakis [3- (3,5-t-butyl-4-hydroxyphenyl) propionate], 2,2-thiodiethylenebis [3- (3,5-di_t-butyl-1-hydroxyphenyl) propionate], 2,2-thiobis (4-methyl_6-t-butyl Thiophenol), N, N'-bis [3- (3,5-di-tert-butyl-4-hydroxyphenyl) propionyl] hydrazine, and the like, and Grignard reagents include salts and iodine.

It is desirable that these electrophilic reagents are used 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 base rubber or plastic component. .

These lubricants and lubricants are blended with an electrophile, a rubber or plastic component, and a bridging agent. For example, injection molding is performed in a mold at a temperature of 140 ° C to 200 ° C, and By performing the crosslinking treatment by applying a pressure of usually 2 OMPa or less as needed, a sliding valve for a syringe in which a lubricating component is chemically bonded can be obtained. The crosslinking can be carried out by a method known as a method for crosslinking these base rubber components or plastic components.

In addition to the above, various modifiers (antioxidants, crosslinking assistants, processing assistants, 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 sliding valve for a syringe of the present invention (the plunger for a syringe with a sliding valve), the syringe sliding valve in which the lubricating component is integrated with the rubber component or the plastic component by chemical bonding has a sufficient lubricating property. However, there is no risk that the lubricating components may be mixed into the drug due to elution or peeling-off. Further, since the sliding valve itself has lubricating properties, it is not necessary to use a silicone coating treatment or a combined use with a lubricating film or the like, or the amount of the combined use can be reduced, and safety is enhanced. 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 chemical solution. As the material of the cylinder part which forms the syringe in combination with the sliding valve of the present invention (the plunger for a syringe with a sliding valve), a commonly used material, that is, a polyolefin-based material such as glass, polypropylene or amorphous polyolefin is used. Compounds can be adopted. In particular, those having a cyclic olefin copolymer as a unit satisfy safety, heat resistance, cold resistance, transparency, high precision, gas barrier properties, chemical resistance, and other properties required for syringes. It is desirable because it is easy.

[Best Mode for Carrying Out the Invention]

Hereinafter, the shape of the sliding valve of the present invention will be specifically described with reference to the drawings.

1 (a) to (f) show examples of the shape of the sliding valve of the present invention.

These are generally cylindrical slide valves for syringes, and have annular lips (b1, b2, or b3) that contact the inner wall of the syringe barrel and divide the space before and after the slide valve a in a watertight manner. And of the holding part (c 1 or c 2), which is in contact with the inner wall of the syringe cylinder and regulates the substantially cylindrical axis of the slide valve so as to match the axis of the syringe cylinder, in the leading direction of the slide valve at the time of injection. The annular lip or the holding portion is a sliding valve for a syringe provided inside at a distance from an end of the substantially cylindrical sliding valve.

FIG. 1 (a) has two sine-shaped annular lips b1, and FIG. 1 (b) shows one wavy annular lip b2 and a ring-shaped annular lip b2. Indicates a sliding valve having one and two.

Fig. 1 (c) shows a sliding valve with a single annular lip b3 in the shape of a combination of two wave shapes (a sea-wall pattern), and Fig. 1 (d) shows a ring-shaped valve. A sliding valve with two annular lips b2 is shown.

The sliding valve shown in Fig. 1 (e) and Fig. 1 (f) is suitable as an intermediate sliding valve (middle stopper).

Vacuum filling performed with a syringe-type kit product ■ In the sliding valve shown in FIG. 1 (a) and FIG. 1 (b), the space indicated by the symbol, ′, ie, the space formed by the two annular lips and the inner wall of the injection cylinder, respectively, The space created is decompressed, and drug solution may enter between the annular lip and the syringe, causing the operator to distrust the kit. However, the sliding valve shown in FIGS. 1 (e) and 1 (f) has only one annular lip which contacts the inner wall of the syringe barrel and divides the space before and after the sliding valve in a watertight manner. However, since there is no decompressed closed space, such a problem does not occur. These sliding valves include a plurality of holding portions c 1 (Γ-shaped) and c 2 (c) for making the axis of the substantially cylindrical sliding valve in contact with the inner wall of the injection cylinder always coincide with the axis of the injection cylinder. “W” shape) is formed.

The shape of the holding portion may be substantially the same as that of the annular lip, and may be partly discontinuous in a “C” shape. In addition, although the appearance is the same as that of the annular lip, Section, a tunnel section, and the like, and as a result, the space before and after the section may not be divided in a watertight manner. In the present invention, these sections are also referred to as holding sections.

Such an intermediate slide valve has a large liquid contact area due to its shape, so when silicone coating is applied, there is a concern that the silicone compound elutes into the chemical liquid compared to a normal shape slide valve. There is. However, since the lubricating component is made of rubber chemically bonded or the lubricating component is made of plastic chemically bonded, the silicone coating is unnecessary or the amount used can be reduced. In addition, an example in which the present invention is applied to a sliding valve for a syringe in the present invention will be described with reference to FIG. 2. FIG. An annular lip that divides the space in a watertight manner, a holding part (six in this example) that is in contact with the inner wall of the syringe cylinder and regulates the substantially cylindrical shaft of the slide valve so that it matches the axis of the syringe cylinder. Is the front surface of the sliding valve body An intermediate sliding valve main body A 1 having a bypass hole 3 penetrating from the rear surface to a rear surface thereof; and a bypass mosquito L 3 inner wall formed around a side surface near one bottom side of a columnar body longer than the bypass hole 3. A sealing valve 10 is formed to contact the airtight and water-tightly divides the space before and after it, and has a groove-shaped liquid passage 11 reaching the bottom of the other side from the portion in contact with the sealing valve on the side surface, and slides into the bypass hole 3. It consists of a slide valve A2 that is movably housed, and the direction of travel of the slide valve at the time of injection. The first annular lip or holding part is located at a distance from the end of the substantially cylindrical slide valve. The intermediate slide valve A for a syringe-type kit preparation having a substantially cylindrical shape is shown.

When the sliding valve advances to the left in the figure, a holding portion 2 is provided at a distance from an end face 4 which is an end of the substantially cylindrical sliding valve. When traveling to the right in the figure, an annular lip 1 is provided at a distance 8 from the end face 5 which is the end of the substantially cylindrical slide valve.

When the intermediate sliding valve A advances to the right in the drawing direction at the time of injection, the annular lip 1 becomes the leading annular lip in the traveling direction, and when the intermediate sliding valve A proceeds to the left in the drawing direction, the holding unit 2 moves to the leading end in the traveling direction. (In these cases, the directions in which the slide valve A2 is set in the bypass hole 3 are opposite to each other.)

The case where the intermediate sliding valve A advances to the left in the figure at the time of injection will be described below.

Fig. 2 (b), Fig. 2 (d), Fig. 2 (f) and Fig. 2 (h) are Fig. 2 (a), Fig. 2 (c :), Fig. 2 (e), respectively. FIGS. 2 (a) and 2 (b) are views of FIG. 2 (g) obliquely from the right. FIGS. 2 (a) and 2 (b) show the state of the intermediate sliding valve body A1 alone, and FIGS. FIG. 3 is a view showing a state of the slide valve A2 alone.

2 (e) and 2 (f) show a state in which the slide valve A2 is slidably housed in the bypass hole 3 of the intermediate slide valve body A1 (state before use). At this time, the sealing valve 10 of the slide valve A2 is in contact with the inner wall of the bypass hole 3, and the bypass hole 3 is sealed. It is in a state of being left.

The intermediate sliding valve advances leftward by the injection operation, and the left side surface 12 of the slide valve A2 comes into contact with the bottom surface of the syringe barrel (not shown) on the injection needle side. A2 slides leftward relative to the intermediate sliding valve main body A1, and the seal formed by the sealing valve 10 and the bypass hole 3 is released, and the intermediate sliding valve A The chemical solution (not shown) on the left side can move to the right side (injection needle side) of the slide valve A2 through the space between the groove-shaped liquid passage 11 of the slide valve A2 and the inner wall of the bypass hole 3.

Next, the operation method of an example of a kit preparation using a serial sequential dispensing syringe having the intermediate sliding valve A will be specifically described with reference to FIGS. 3 (a) to 3 (d).

Fig. 3 (a) Reference numeral 21 indicates a glass syringe (normal).

For example, a lidocaine hydrochloride (infiltration anesthetic) liquid is filled as a first agent 25 in a watertight space formed by the injection cylinder 21 and the intermediate sliding valve A of this kit preparation.

In addition, the injection cylinder 21, the intermediate slide valve A, and the plunger slide valve 22 (the plunger slide valve 22 is also a substantially cylindrical slide valve according to the present invention, and is in contact with the inner wall of the syringe cylinder. Of the annular lips that divide the space before and after the sliding valve in a watertight manner, the leading annular lip in the direction of travel of the sliding valve during injection is provided at a distance from the end of the substantially cylindrical sliding valve. ) Is filled with, for example, sodium hyaluronate as the second agent 26.

The injection needle connection part 21 a of the injection cylinder 21 is sealed by a cap 24 made of resin or rubber.

Prior to use of such a kit preparation, the cap 24 is removed as shown in FIG. 3 (b), and the injection needle 27 is attached to the injection needle connection portion 21a of the injection cylinder 21. At this time, by operating the plunger operation part 22 a with the injection needle side facing up, even if there is air that has entered the part of the first agent 25 when the needle is attached, it can be completely removed. Can be. If it is necessary to reduce the injection amount of the first agent 25, the plunger operation section 22a is operated at this stage to reduce the injection amount.

Next, the injection needle 27 is pierced into the required injection site, and then the plunger operation part 22a is moved to the tip end of the syringe cylinder to inject the first agent 25.

The state immediately before the injection of the first agent 25 is completed when the intermediate slide valve A reaches the end point on the distal end side of the syringe cylinder and the injection of the second agent 26 is shown in FIG. 3 (c).

At this time, since the slide valve A2 of the intermediate slide valve A slides to the state shown in FIGS. 2 (g) and 2 (h), the second agent 26 behind the intermediate slide valve A becomes the slide valve. Through the space between the groove-shaped liquid passage 11 of A 2 and the inner wall of the bypass hole 3, the slide valve A can move to the right side (the injection needle 27 side) of the sliding valve A.

When the operation of the plunger 22a is continued following the above, the second agent 26 behind the intermediate slide valve A reaches the needle 27 through the formed bypass fluid passage, and is injected. The injection is completed as shown in Fig. 3 (d). When it is necessary to reduce the injection amount of the second agent 26, the injection operation may be ended with the second agent 26 remaining in the syringe 1.

As described above, the kit preparation according to the present invention has the intermediate sliding valve A inside the injection cylinder 21, and the mechanism of the intermediate sliding valve A prevents the injection solutions 25 and 26 from mixing. Although the injection can be performed surely sequentially, since the intermediate sliding valve A and the plunger sliding valve 22 are related to the present invention, the injection can be performed with an extremely smooth operation feeling in these operations.

[Example]

Hereinafter, examples of the present invention will be described.

First, the shape of the sliding valve used in the experiment will be described.

A slide valve having the shape shown in Fig. 4 (a) (the center is a cross-sectional view, the left side is a left side view, and the right side is a right side view) is a substantially cylindrical syringe plunger slide valve (prior art) according to the prior art. Comparison Example 1) 30 which is compatible with a 5 ml syringe.

Of the annular lips 31 to 33 that contact the inner wall of the injection cylinder of the sliding valve and divide the space before and after the sliding valve in a watertight manner, among the annular lips 3 1 to 33 in the leading direction of the sliding valve during injection, 1 is provided at the end 34 of the substantially cylindrical sliding valve, and the rearmost annular lip 33 is provided at the rear end 37 of the substantially cylindrical sliding valve.

Reference numeral 35 denotes a convex portion for securing a passage for the chemical solution immediately before the end of the injection, and reference numeral 36 denotes a plunger (not shown). It is a convex portion for preventing it from coming off.

The slide valve having the shape shown in FIG. 4 (b) (the center is a sectional view, the left side is a left side view, and the right side is a right side view) is a substantially cylindrical slide valve for a syringe according to the present invention (implementation). Example 1) 40, and among the annular lips 41 to 43 that contact the inner wall of the syringe barrel and divide the space before and after the sliding valve in a watertight manner, among the annular lips 4 1 to 43 in the leading direction of the sliding valve at the time of injection. 1 is a plunger sliding valve for a syringe provided at a distance (1.6 mm) from the end 44 of the substantially cylindrical sliding valve, and the rear annular lip 43 is also substantially cylindrical. It is provided at a distance (1.6 mm) from the rear end 47 of the slide valve. The slide valve 40 has the same shape and size as the syringe slide valve 30 except for the positions of the annular lips 41 and 43.

FIG. 5 shows a plunger 50 (Example 2) for a syringe with a sliding valve according to the present invention 50 having a substantially cylindrical sliding valve portion 50a at the tip of the plunger portion 50b (Example 2). Of the annular lips 5 1 to 5 3 that contact the inner wall and divide the space before and after the sliding valve portion in a water-tight manner, among the annular lips 5 1 to 5 3, the leading annular lip in the sliding valve traveling direction at the time of injection 5 1 A substantially cylindrical sliding valve The sliding valve portion 50a is provided at a distance from the end of the portion 50a, and a cylindrical hollow portion 58 coaxial with the substantially cylindrical sliding valve portion is provided inside the sliding valve portion 50a. A plunger portion smaller than the cylindrical hollow portion so as to leave a gap in the axial direction (0.5 mm on both sides) and a circumferential direction (0.5 mm over the entire circumference) in the cylindrical hollow portion. Cylindrical tip The sliding valve portion 50a is held by the plunger portion 50b by the cylindrical distal end portion 50b1 and the sliding valve portion 50a is inserted. From the position of the annular lip 51 at the leading end in the traveling direction, the bottom of the cylindrical hollow portion 58 inside the sliding valve portion 50a is located at the distal end side of the sliding valve portion 50a. 1 mm) is a plunger for a syringe with a sliding valve.

The structure and dimensions of the sliding valve portion 50a of the plunger 50 for a syringe with a sliding valve are the same as those of the sliding valve 40 except for the structure of the cylindrical hollow portion therein.

[Evaluation with tester]

Using these three types of butyl rubber slide valves (plungers are screwed into slide valve 30 and slide valve 40, respectively), silicone oil is applied so that they have the same thickness. Apply it and set it in a glass syringe. At that time, without a syringe needle and without filling with a drug solution, the head speed was 10 mmZ for 6 seconds (injection volume: 1.1 m I 6 (Speed equivalent to seconds) Adjusted using an autograph manufactured by Shimadzu Corporation.

The evaluation was performed by averaging the operating force of a total of 5 points at the start (start of measurement), immediately before the end of measurement, and at points (3 points) where the distance was divided into five equal parts.

Further, two types of sliding valves for syringes (Examples 3 and 4) each having the same shape as those of Examples 1 and 2 and made of rubber to which a lubricating component is chemically bonded were prepared and evaluated in the same manner. Was done.

That is, butyl rubber (Nippon Synthetic Rubber, butyl 268), filler (Nippon Silicite, Nibusir VN ₃ ), zinc oxide, zeo (colloid), 2-mercaptobenzothiazole (M; large) as a vulcanization accelerator Uchi-Shinko Chemical), zinc dibutyldithiocarbamate (BZ: Ouchi-Shinko Chemical), tetramethylthiuram disulfide (TT: Ouchi-Shinko Chemical), and polytetrafluoroethylene powder as a lubricant PTFE powder, particle diameter of 20 m or more and 30 m or less) and silicone-based grease as a lubricant Table 1 composition unvulcanized rubber composition obtained by mixing so that the weight ratio shown in 1 in the mold 1 6 0 ° C '1 5 minutes, at 1 3 0 kg pressure of Z cm ² It was heated to form a sliding valve.

Table 1 shows the results obtained when the force of the sliding valve of Comparative Example 1 was set to 100 for the force required for the operation at this time.

〔table 1〕

Table 1 shows that the force required for operating the sliding valve according to the present invention is clearly smaller than that of the sliding valve according to the prior art.

[Evaluation by liquid injection test]

A drug solution injection test was performed. This is a monitor test using a glass syringe with 10 physicians as monitors.

The test was performed using saline as the injection solution and attaching a 25 G (gauge) needle assuming intravenous injection. Evaluate the feel of the plunger at the start of pushing (initial slidability) and the ease (interruptability) when interrupting at the total injection volume of 13 (10 levels), with 10 being the best and 1 being the best. The result was averaged, and the result was rounded off. Table 2 shows the results. At this time, the details of the samples were not explained for each monitor, and they were performed in any order. Table 2 shows the results 2]

Table 2 shows that the operability of the sliding valves according to the present invention in Examples 1 to 4 was remarkably good.

[Test assuming kit preparation]

Further, experiments were conducted on the assumption that the slide valve according to the present invention is applied to a kit preparation. The 1% provophor solution is an emulsion, and when filled in a syringe and left for a long time, the plunger operation feeling may become heavy ("squeaking" may occur). The “squeaking feeling” in the plunger operation feeling may cause the needle to come off from the secured vein in the case of intravenous injection. We examined whether this problem could be solved by the sliding valve of the present invention.

A 1% propofol solution (5 ml) was sucked into a glass syringe in which the plungers with sliding valves of Comparative Example 1 and Examples 1 to 4 were set, and allowed to stand at room temperature for 24 hours.

Thereafter, a 25 G needle was attached assuming intravenous injection, and a test was performed by 10 physicians in the same manner as described above. The presence or absence of “squeaky feeling” was also evaluated, and the number of people concerned about the squeaky feeling was examined.

Table 3 shows the results. (Table 3)

Table 3 shows that the sliding valves according to the present invention are significantly better in Examples 1 to 4 in the experiment in which the kit preparation was taken into consideration. In addition, it can be seen that the sliding valves of Examples 1 to 4 have almost completely eliminated the squeakiness caused by the sliding valve of Comparative Example 1.

[The invention's effect]

The sliding valve for a syringe according to the present invention is an excellent sliding valve for a syringe that can be extremely smoothly slid due to its unique configuration and that can be injected into a stable place with little failure during injection.

[Brief description of drawings]

1 (a) to 1 (f) are diagrams showing examples of the shape of the sliding valve of the present invention.

FIG. 2 is a view showing an intermediate sliding valve A for a syringe-type kit preparation.

(a), (b) is a diagram showing an intermediate sliding valve body A1.

(c), (d) is a view showing a slide valve A2.

(e), (f) is a diagram showing an intermediate sliding valve A for a syringe-type kit formulation by combining the intermediate sliding valve body A1 and the slide valve A2.

(g), (h) shows the state after using the intermediate slide valve A for a syringe-type kit preparation. FIG. 3 (a) to (d) are diagrams showing an operation method of an example of a kit preparation using an in-line sequential injection syringe having an intermediate slide valve A for a syringe-type kit preparation.

Fig. 4

(a) is a diagram showing a sliding valve according to the prior art.

(b) is a view showing a sliding valve according to the present invention.

Fig. 5

It is a figure showing the plunger for syringes with a slide valve concerning the present invention.

(a) It is a figure which shows the sliding valve part front end surface.

(b) It is sectional drawing near a sliding valve part.

(c) is an overall sectional view.

Fig. 6

It is a figure showing a sliding valve concerning a conventional technology.

Claims

The scope of the claims

1. A substantially cylindrical slide valve for a syringe, which is in contact with the inner wall of the syringe cylinder and divides the space before and after the slide valve in a watertight manner, and an approximate lip of the slide valve which is in contact with the inner wall of the syringe cylinder. Of the holding part that regulates the cylindrical axis so that it matches the axis of the syringe barrel, the sliding valve travel direction at the time of injection The leading annular lip or holding part is located at a distance from the end of the substantially cylindrical sliding valve. A sliding valve for a syringe, characterized in that the sliding valve is provided.

2. The slide valve for a syringe according to claim 1, wherein the slide valve for a syringe is a syringe slide valve for a kit preparation having a plurality of slide valves in one syringe.

3. The sliding valve for a syringe according to claim 1 or 2, wherein the sliding valve for a syringe is made of rubber having a lubricating component chemically bonded or plastic having a lubricating component chemically bonded. .

4. A syringe plunger with a sliding valve having a substantially cylindrical sliding valve at the tip of the plunger, wherein the ring is in contact with the inner wall of the syringe barrel and watertightly divides the space before and after the sliding valve. Of the lip and the holding portion which contacts the inner wall of the syringe barrel and regulates the substantially cylindrical shaft of the sliding valve portion so as to match the shaft of the syringe barrel, the leading annular lip in the sliding valve advancing direction at the time of injection. Alternatively, the holding portion is provided at a distance from the end of the substantially cylindrical sliding valve portion, and a cylindrical hollow portion coaxial with the substantially cylindrical sliding valve portion is provided inside the sliding valve portion. The cylindrical tip portion of the plunger portion having a size smaller than the cylindrical hollow portion is inserted so as to leave an axial gap and / or a circumferential gap in the cylindrical hollow portion. The sliding valve portion is held by the plunger portion by the cylindrical tip portion, and the leading end of the sliding valve portion in the traveling direction is moved forward. For a syringe with a sliding valve, characterized in that the position of the bottom of the cylindrical hollow portion inside the sliding valve portion is located on the tip side in the direction of travel of the sliding valve portion from the position of the lip or holding portion. Plunger

5. The plunger for a syringe with a slide valve is a plunger with a slide valve for a syringe-type kit preparation having a plurality of slide valves in one syringe. 4. The plunger for a syringe with a sliding valve according to 4.

6. The syringe with a sliding valve according to claim 4, wherein the sliding valve portion is made of rubber having a lubricating component chemically bonded or plastic having a lubricating component chemically bonded. Plunger.