JP2002291842A - Kneading container, injector and kneader - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a kneading container capable of simply performing the kneading work of a powder and a liquid aseptically in a non-mannually operable manner, and an injector using the kneading container housing kneaded matter as the injector to inject the kneaded matter in the body aseptically and simply. SOLUTION: The kneading container is a double container consisting of an inner container 11 housing the powder and the liquid and the outer container 2 housing the inner container in a detachable manner and constituted so as to apply simultaneously revolution and rotation to the outer container having housed the inner container or to apply vibration thereto to knead the powder and the liquid. A lock mechanism not changing the relative position of the outer and inner containers is provided and the inner container has an inner container body having a first opening for discharging the kneaded matter and a second opening in which an extrusion member is inserted, and first and second cover members 13 and 14 for sealing the first and second openings in a freely detachable manner. The injector including the inner container body, an injection member and the extrusion member is also disclosed.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a kneading container, an injector and a kneading apparatus capable of aseptically producing a filling material and a slurry for a living body.

[0002]

2. Description of the Related Art Conventionally, in order to knead calcium phosphate cement that can be used as a biocement, a method has been known in which a liquid such as calcium phosphate powder and water is put into a mortar and kneaded manually with a pestle. (Japanese Patent Laid-Open No. 64-3744)
No. 5, JP-A-4-328185, etc.). Such calcium phosphate cement hardens at a pH around neutrality by simply mixing with water, so there is no biological irritation,
It can be used to compensate for bone defects, fix and repair fractures, and more. However, since the kneading of the powder and the liquid is usually performed using a mortar and pestle, the operation is complicated, and there is a possibility that impurities and various bacteria may be mixed. Further, in order to inject the kneaded cement paste into the body, it was necessary to transfer the paste to a syringe, so that the operation was complicated as in the kneading operation, and there was a possibility that impurities and various germs might be mixed. there were.

[0003]

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a kneading container capable of easily performing a kneading operation of a powder and a liquid in an aseptic manner and without manual operation. is there. Another object of the present invention is to provide an injector that allows a kneading container containing a kneaded material to be used as it is as an injector, and that can inject the kneaded material into a body aseptically and easily.

[0004]

In order to achieve the above object, the present invention provides a double container comprising an inner container for holding powder and liquid, and an outer container for detachably housing the inner container. Simultaneously applying revolving rotation and rotation to the outer container containing the inner container, or applying a vibration to knead the powder and liquid in the inner container, the kneading container, A lock mechanism that does not change the relative position between the outer container and the inner container is provided, and the inner container has a first opening for discharging the kneaded material and a second opening for inserting the pushing member. A kneading container for aseptic kneading, comprising: a main body; and first and second cover members for removably sealing the first and second openings, respectively.
In this kneading apparatus, the lock mechanism may include a recess formed on the inner bottom surface of the outer container, and a projection provided on one of the cover members of the inner container and capable of being fitted into the recess. In this kneading apparatus, a locking portion is provided on the outer surface of the inner container body, and is screwed and externally fitted to a cover member on which a projection serving as a locking mechanism is formed, and locked to the locking portion. A stopper may be provided to prevent the cover member from loosening and moving out of the inner container body. In this kneading apparatus, the cover member on which the protrusion is formed is screwed and fitted to the inner container body, and the cover member and the stopper are screwed so as to have a reverse screw relationship. obtain.

[0005] The present invention also provides an injection member having an inner container body of the kneading container, a base attached to the first opening side of the inner container body, and an injection tube extending from the base.
A push member inserted through a second opening of the inner container body. The present invention also provides an inner container body of a kneading container, a luer lock having a base attached to the first opening side of the inner container body and an attaching portion to which an injection needle can be attached, and a second container of the inner container body. A pusher inserted through the opening. In this injector,
It may further include an injection needle attached to the luer lock. Further, the present invention provides a kneading apparatus for producing a sterile kneaded product, comprising: the kneading vessel; and a kneading apparatus main body that simultaneously performs revolving rotation and rotation on the kneading vessel.

[0006]

Embodiments of the present invention will be described below in detail with reference to the drawings. FIG. 1 shows an embodiment of the kneading container according to the present invention. The kneading container 1 includes an outer container 2 including an outer container main body 3 and an outer lid 4 that detachably covers an upper opening thereof, and an inner container 11 that is detachably accommodated in the outer container 2. It has a heavy container structure.

FIG. 2 shows the outer container 2. The material of the outer container 2 is not particularly limited as long as it can be sterilized by a sterilization method selected from an ethylene oxide gas sterilization method, an autoclave sterilization method, a gamma irradiation sterilization method, an electron beam irradiation sterilization method, and the like. For example, it can be manufactured using a plastic material such as polypropylene, polyethylene, polyethylene terephthalate, nylon, and polycarbonate, and a metal material such as stainless steel. Preferably, it is made of a transparent hard plastic such as polycarbonate so that the inner container 11 can be seen from the outside. The shape of the outer container 2 is not particularly limited as long as the inner container 11 can be accommodated and held so as not to move.

In this embodiment, the outer container body 3 has a bottomed cylindrical shape. A concave portion 10 extending crosswise from the center is formed on the inner bottom surface of the outer container body 3. In addition, a plurality of supports 9 are provided at regular intervals along the circumferential direction below the outer peripheral surface of the outer container 3. An engagement portion 8 for detachably attaching the outer lid 4 is formed at an upper end portion of the outer container body 3.

The outer lid 4 is preferably used so as to cover the upper opening of the outer container body 3 and be detachable by a simple operation.
In the present embodiment, a ring-shaped holding projection 5 for holding the inner container 11 in contact with the upper part of the inner container 11 and a radially inner side than the peripheral hanging portion of the outer lid 4 are provided at a central portion on the inner surface side (the side in contact with the inner container 11). Is provided with a ring-shaped insertion protrusion 6, and when the outer cover 4 is put on the outer container body 3, the outer lid 4 is structured such that the upper end of the outer container body 3 is sandwiched between the peripheral hanging portion and the insertion protrusion 6. Have.
The outer lid 4 is provided at its periphery with an engaging projection 7 for engaging with the engaging portion 8 at the upper end of the outer container body 3 and holding the outer lid 4 to such an extent that the outer lid 4 can be easily removed. The engagement structure by the engagement portion 8 and the engagement protrusion 7 is not particularly limited as long as the purpose of holding the outer lid 4 to such an extent that the outer cover 4 can be easily removed is not limited. A structure in which the engagement protrusion 7 enters and exits the groove portion by elastic deformation of the peripheral hanging portion of the outer lid 4, or a structure in which the engagement portion is a female screw and the engagement protrusion 7 is a male screw may be employed.

As shown in FIG. 1, the inner container 11 includes an inner container main body 12, an upper cover member 13 for detachably closing an upper opening of the inner container main body 12, and a lower side of the inner container main body 12. And a lower cover member 14 that removably closes the opening. The material of the inner container 11 is not particularly limited as long as it can be sterilized by a sterilization method selected from an ethylene oxide gas sterilization method, an autoclave sterilization method, a gamma irradiation sterilization method, an electron beam irradiation sterilization method, and the like. For example, it can be manufactured using a plastic material such as polypropylene, polyethylene, polyethylene terephthalate, nylon, and polycarbonate, and a metal material such as stainless steel.

FIG. 3 shows the inner container body 12. The inner container main body 12 has a substantially cylindrical shape, and a flange 16 serving as a holder when the inner container main body 12 is used as an injector has a flange-like shape facing outward in the center in the longitudinal direction. Is formed. Screws 17 and 18 for screwing the upper cover member 13 and the lower cover member 14, respectively, are formed on the outer periphery of both ends of the inner container body 12. The upper cover member 13 may be shaped like a cap nut.

As shown in FIGS. 4 and 5, the lower cover member 14 is provided with a screw 1 screwed to the screw 18 of the inner container body 12.
9 is configured such that a cross-shaped protrusion 15 to be fitted into a cross-shaped concave portion 10 formed on the inner bottom surface of the outer container main body 3 is provided on a main body having a cap nut shape formed on the inner peripheral surface. . When the inner container 11 is accommodated in the outer container 2, the combination of the concave portion 10 and the protrusion 15 fits into the cross-shaped concave portion 10 formed on the inner bottom surface of the outer container body 3, and
This is a lock mechanism for preventing relative rotation and movement of the inner container 11 with respect to.

The kneading container 1 configured as described above is
Various powders and liquids are put into the inner container 11 from which one of the cover members 13 has been removed, and the cover member 13 is inserted into the inner container body 12.
Is screw-fitted and sealed, and housed in the outer container body 3. After the projection 15 of the lower cover member 14 is fitted into the cross-shaped recess 10 formed on the inner bottom surface of the outer container body 3, the outer lid 4 is put on the outer container body 3. In this stored state, as shown in FIG. 1, the inner container 11 is configured such that the projection 15 of the lower cover member 14 serving as a lock mechanism is fitted into the recess 10 of the outer container body 3, and the upper end of the inner container 11 The relative rotation and movement of the inner container 11 with respect to the outer container 2 are stopped by inserting and supporting the portion into the holding protrusion 5 of the outer lid 4, and the relative rotation and movement of the inner container 11 with respect to the outer container 2 are prevented. Movement has been stopped.

Next, the kneading vessel 1 is set in a kneading apparatus, and the powder and liquid in the inner container 11 are aseptically and simultaneously applied by revolving rotation and rotation simultaneously, or by applying strong vibration. Knead manually. The mixing container 1
The method of mixing the powder and the liquid in the inner container 11 by simultaneously applying the revolving rotation and the rotation to the spinner is, for example, “Spinkle” (trade name, manufactured by Morita Tokyo Seisakusho) or “Awatori Rentaro” (trade name, 1) into this mixing vessel 1
It can be easily implemented by adding a revolving rotation of 500 rpm or more and a rotation of 300 rpm or more and kneading for about 5 to 60 seconds. In addition, according to the "spincle", kneading is performed at a revolution of 2500 rpm and a rotation of 500 rpm.
According to "Awatori Rentaro", the revolution speed is 2000rpm,
The mixture is kneaded at 400 rpm. The powder and liquid contained in the inner container are uniformly kneaded in a short time by being pressed against the wall surface by the centrifugal force of the revolution and the rotation. When using a kneading device that applies revolving rotation and rotation to the kneading container, such as “spincle” or “awatori neritaro”, a support 9 having a shape adapted to the fitting portion of the container of the rotating device is used. Must be provided in the outer container 2.

More specifically, one cover member 13 of the sterilized inner container 11 is removed, and a powder such as calcium phosphate cement and a liquid such as water are put into the inner container 11.
The inner member 11 is sealed by screwing the cover member 13.
Thereafter, the entire inner container 11 is set in the sterilized outer container 2 and the outer lid 4 is closed. Thereafter, the kneading container 1 is set in the above-mentioned "spincle" or "Awatori Nentaro", and the powder and the liquid are kneaded by revolving and rotating. Since it is difficult to sterilize the entire kneading apparatus, the exterior of the outer container 2 is not sterile at this time. However, after completion of the mixing, the mixing container 1
Is removed from the kneading apparatus, the outer lid 4 is opened, and the inner container 11 is aseptically taken out, so that the inner container and the outer surface of the inner container 11 remain aseptic. Therefore, even when the operator himself takes out the kneaded material contained therein during the operation, it can be easily taken out while maintaining the aseptic condition. In addition,
Since the inner container 11 and the outer container 2 have a lock mechanism for fitting the protrusion 15 into the recess 10, the outer container 2 is used for kneading.
Even if revolving rotation and rotation are added to the inner container, the inner container 11 is rotated during rotation.
Can efficiently knead the powder and liquid contained in the inner container 11 without idling.

As a kneading method other than the above, for example, a method of shaking the kneading container 1 by hand or mechanically applying vibration (for example, "Amalgam mixer", manufactured by Shofu Co., Ltd.) can be adopted.

When the powder and the liquid are stored in the mixing vessel 1 of the present invention, it is desirable that the mixing ratio (P / L) of the powder and the liquid be 4.5 or less by weight. If the amount of powder is more than this, a uniform kneaded product cannot be obtained. Further, the amount of the kneaded material (powder and liquid) contained in the inner container 11 is such that the inner volume of the inner container 11: the volume of the kneaded material is 1: 0.9 to 0.1 in volume ratio. A range is preferred.

After the kneading, the inner container 11 is taken out, and
After removing both cover members 13 and 14, the inner container body 1 is removed.
2 for extruding the kneaded material in the inner container body 12 from the injecting member by attaching the injecting member and the extruding member to the body 2, more specifically, inserting the tip of the injecting member into the body to knead the kneaded material. Can be configured for injecting into the body.

The injector of the present invention can be composed of an inner container body 12 containing a kneaded material, injection members 20, 23, and an extrusion member 30 (see FIG. 9). FIG. 6 shows an example of an injection member suitable for constituting the injector of the present invention. The injection member 20 includes a base 21 that can be screwed to one of the screws 17 and 18 formed on the inner container body 12, and an injection pipe 22 extending from the base 21. The tip of the injection tube portion 22 is tapered so that the tip can be inserted into the body or can be inserted through a fine hole.

FIG. 7 shows another example of an injection member suitable for constituting the injector of the present invention. The injection member 23 includes a base 24 that can be screwed to one of the screws 17 and 18 formed on the inner container body 12 and an injection pipe 25 that extends from the base 24. Is formed of a circular pipe having the same thickness.

Further, the injector according to the present invention comprises an inner container body 12 containing a kneaded material and a luer lock 26 to which an injection needle can be attached.
And an extruding member 30 (see FIG. 9). FIG. 8 shows an example of a luer lock 26 suitable for constituting the injector of the present invention. This lure lock 26
Is one of the screws 17, formed on the inner container body 12,
It has a base 24 that can be screwed to the mounting 18 and a mounting portion 28 to which an injection needle can be mounted.

FIG. 9 shows an example of the injector of the present invention. After the mixing, the injector 29 is
An inner container main body 12 from which the inner container body 3 and 14 are removed, a luer lock 26 in which a base 27 is screwed and fitted to the screw 18 of the inner container main body;
A push member 30 inserted from an opening of the inner container end 12 opposite to the luer lock 26. An injection needle (not shown) is screwed into the mounting portion 28.

As the pushing member 29, a commercially available plastic or glass piston for a syringe can be used. The shape of the distal end portion of the pushing member 29 is not particularly limited as long as a dead space is not generated at a contact portion between the pushing member 29 and the inner container body 12 and the luer lock 26 when the kneaded material in the inner container body 12 is extruded. Not limited. In the example of FIG. 9, a rubber gasket 31 having a convex shape corresponding to the internal shape of the luer lock 26 is attached to the tip of the pushing member 30.

The injector 29 is capable of aseptically injecting the kneaded product from a syringe needle into a desired portion, for example, a living body. That is, after kneading, the cover member 14 of the inner container 11 taken out of the outer container 2 is removed, a sterilized luer lock 26 is attached, the remaining cover member 13 is removed, and the sterilized extruded member is attached to the inner container body 12. Then, the sterilized injection needle is attached to the attachment portion 28 of the luer lock 26. If these series of operations are performed in a sterile atmosphere, the kneaded material in the inner container body 12 can be aseptically injected into a desired location. For example, when supplementing the kneaded material for living body to the fracture site, a syringe needle may be inserted into the fracture site and a desired amount of the kneaded product may be injected. The powder for the production of a kneaded cement for a living body contains α-type tribasic calcium phosphate and / or quaternary calcium phosphate as essential components, and further contains dibasic calcium phosphate and first calcium phosphate as optional components.
A powder or a powder composition containing calcium phosphate is exemplified. Further, if this injector is used, the kneaded material can be injected into a cavity for producing a small molded body.

FIG. 10 shows another embodiment of the kneading container of the present invention. In this embodiment, the same outer container as the outer container 2 in the kneading apparatus 1 of the embodiment shown in FIG. 1 can be used. The present embodiment is characterized in that an inner container 41 provided with a stopper 45 for preventing the lower cover member 44 from being loosened during kneading is used.

An inner container 41 shown in FIG. 10 has a substantially cylindrical inner container body 42, and an upper cover member 43 and a lower cover member 44 for removably closing both openings of the inner container body 42.
And a stopper 4 screwed onto the lower cover member 44.
5 is provided as a main component. The material of the inner container 11 is not particularly limited as long as it can be sterilized by a sterilization method selected from an ethylene oxide gas sterilization method, an autoclave sterilization method, a gamma irradiation sterilization method, an electron beam irradiation sterilization method, and the like. For example, it can be manufactured using a plastic material such as polypropylene, polyethylene, polyethylene terephthalate, nylon, and polycarbonate, and a metal material such as stainless steel.

FIG. 11 shows the inner container body 42 according to this embodiment.
The inner container body 42 has a substantially cylindrical shape and has one end (FIG. 1) from the center in the longitudinal direction.
In the position near the upper end portion of FIG. 1, a flange 47 serving as a holder when the inner container body 42 is used as an injector is formed in a radially outward flange shape.
An upper cover member 43 is provided around both ends of the inner container body 42.
Screws 49 and 50 for screwing the lower cover member 44 and the lower cover member 44 are formed. Further, a flange-shaped locking portion 46 is formed on the outer periphery of the inner container body 42 at a position closer to the screw 50 below the center in the longitudinal direction, and only the central side in the longitudinal direction of the inner container body 42 gradually projects. .

The upper cover member 43 can be shaped like a cap nut. The lower cover member 44 is configured as shown in FIG.
As shown in FIG. 2, a cross-shaped projection 48 is provided on a cap nut-shaped main body in which a screw 51 screwed to the screw 50 of the inner container main body 42 is formed on the inner peripheral surface. The protrusion 48 connects the inner container 41 to the outer container 2 (see FIGS. 1 and 2).
When the inner container 41 is housed inside, it is fitted into a cross-shaped concave portion 10 formed on the inner bottom surface of the outer container body 3 to prevent the inner container 41 from rotating or moving relative to the outer container 2.
Further, a stopper 4 is provided on the outer peripheral surface of the lower cover member 44.
A screw 52 to which the screw 5 is screwed is formed. The screw 51 formed on the inner peripheral surface of the lower cover member 44 and the screw 52 formed on the outer peripheral surface have a so-called reverse screw relationship in which the rotational directions for screwing and fastening are opposite.

FIG. 13 shows the stopper 45. The stopper 45 has a lower cover member 44 on its inner peripheral surface.
Is formed in a ring shape in which a screw 53 to be screwed with a screw 52 formed on the outer peripheral surface is formed. At its upper end, a locking edge 54 for locking to the tip of the locking portion 46 of the inner container body 42 is formed. The locking edge portion 54 is formed to have a diameter such that the central portion of the inner container body 42 is movable but is locked by the tip of the locking portion 46.

As shown in FIG. 10, the lower cover member 44 is screwed into the inner container body 42, and then the stopper 45 is screwed onto the screw 52 on the outer periphery of the lower cover member 44, as shown in FIG. The locking edge portion 54 is mounted in a state locked by the locking portion 46. The rotation direction for fastening the stopper 45 is opposite to the rotation direction for screwing and fastening the lower cover member 44 to the inner container body 42.

After the inner container 41 is filled with the powder and liquid to be kneaded and the upper and lower cover members 43 and 44 are attached,
As shown in FIG. 1, housed in the outer container 2, the projection 48 of the lower cover member 44 is fitted into the concave portion 10 of the outer container body 3, the outer lid 4 is closed, and the kneading container is put into a kneading device. The powder and the liquid in the inner container 41 are kneaded by setting and simultaneously applying the revolving rotation and the rotation, or applying vibration. By sterilizing the kneaded material, the inner container 41 and the outer container 2, a sterile kneaded material can be obtained in the inner container body 42.

The inner container 41 is provided with a stopper 45 for locking the lower cover member 44 to the inner container body 42 and preventing the inner cover main body 42 from coming off, and the stopper 45 and the lower cover member 44 have a reverse screw relationship. When the kneading of the powder and the liquid is performed by simultaneously applying orbital rotation and rotation to the kneading container containing the inner container 41 in the outer container 2 or applying strong vibration, Even if a force in the direction in which the lower cover member 44 is loosened is applied to the lower cover member 44 via the projection 48 that prevents the rotation of the stopper 41, the stopper 45
Accordingly, the lower cover member 44 is prevented from being loosened, and problems such as liquid leakage due to the loosened lower cover member 44 can be prevented.

FIG. 14 illustrates another example of the injector of the present invention, which is an injector having an inner container body 42 with a stopper according to the present embodiment. This injector 61
A luer lock 62 having a base 63 screwed into the screw 50 of the inner container body 42 and a mounting portion 64 to which an injection needle can be attached is attached to the inner container body 42 having the stopper 45. The push-out member 65 is inserted through the other opening. As the push-out member 65, a commercially available plastic or glass syringe piston can be used. Extrusion member 65
Is not particularly limited as long as a dead space is not generated at a contact portion between the pushing member 65 and the inner container body 42 and the luer lock 62 when the kneaded material in the inner container body 42 is extruded. In the example of FIG. 14, a rubber gasket 66 having a convex shape matching the internal shape of the luer lock 62 is attached to the tip of the pushing member 65.

The injector 61 is capable of aseptically injecting the kneaded material from a syringe needle into a desired portion, for example, a living body. That is, after the kneading is completed and the stopper 45 of the inner container 41 taken out of the outer container 2 is removed, the cover member 44 is removed.
Is removed, a sterilized luer lock 62 is attached, then the remaining cover member 43 is removed, a sterilized push-out member 65 is inserted into the inner container body 42, and a sterilized injection needle is attached to the attachment portion 64 of the luer lock 62. If these series of operations are performed in a sterile atmosphere, the inner container body 42
The kneaded material in the inside can be aseptically injected into a desired location. For example, when supplementing a kneaded material for a living body to a fracture site or the like, a syringe needle may be inserted into the fracture site, and a desired amount of the kneaded product may be injected. The powder for producing a cement kneaded product for a living body contains α-type tribasic calcium phosphate and / or quaternary calcium phosphate as an essential component, and further contains a powder or powder composition containing dibasic calcium phosphate and monocalcium phosphate as optional components. Things. Further, if this injector is used, the kneaded material can be injected into a cavity for producing a small compact.

In each of the above embodiments,
The lock mechanism is composed of a cross-shaped concave portion 10 formed on the outer container 2 side and a cross-shaped projection 15, 48 formed on the inner container 11, 41 side fitted in the concave portion 10. If the inner container can be accommodated in a fixed state in the outer container, the present invention is not limited thereto, for example, a combination of a concave portion and a protruding portion of another shape, a combination of a hook-shaped locking claw and a locking piece, Various locking mechanisms, such as screwing, may alternatively be used.

[0036]

EXAMPLE A calcium phosphate cement powder was used as a powder and was aseptically kneaded in the kneading vessel of the present invention.

Synthesis Example 1 α-type tribasic calcium phosphate 3 mol of calcium hydroxide (manufactured by Ube Materials Co., Ltd.) is suspended in 10 liters of water, and 2 mol of phosphoric acid (manufactured by Lhasa Industries) is added to water. A 40 wt% aqueous solution diluted with was gradually added dropwise with stirring. After the completion of the dropwise addition, the mixture was allowed to stand at room temperature for 1 day, and then dried at 110 ° C. for 24 hours using a drier (Yamato Scientific Co., Ltd., DV61 type). Was. This agglomerate is added to 1400
C. for 3 hours (Superyama 2 manufactured by Motoyama)
035 type). Finally, the mixture was pulverized with a crusher (agitator crusher No. 20 manufactured by Ishikawa Plant Co., Ltd.) and passed through an 88 μm sieve to obtain α-type tribasic calcium phosphate having an average particle size of 6.5 μm.

Synthesis Example 2: Quaternary Calcium Phosphate 4 mol of calcium hydroxide and 2 mol of phosphoric acid were dried in the same manner as in Synthesis Example 1 to obtain an aggregate. 9
After calcining at 00 ° C for 3 hours, taking out and uniformly pulverizing, it was further calcined at 1400 ° C for 3 hours. Finally, a crusher (made by Ishikawa Plant Co., Ltd., agitated crusher vertical type No. 20)
And passed through a 88 μm sieve to give an average particle size of 6.
0 μm quaternary calcium phosphate was obtained.

(Example) The α-type tribasic calcium phosphate of Synthesis Example 1 was 75%, and the quaternary calcium phosphate of Synthesis Example 2 was 2%.
0% and 5% of commercially available calcium hydrogen phosphate dihydrate (manufactured by Wako Pure Chemical Industries, Ltd., special grade) were mixed to obtain a calcium phosphate cement powder. The powder was sterilized by gamma irradiation sterilization. On the other hand, as a liquid, 20 wt% of disodium succinate hexahydrate (special grade, manufactured by Junsei Chemical Co., Ltd.)
%, Sodium chondroitin sulfate (Seikagaku Corporation)
An aqueous solution in which 5% by weight of an injection grade ND product was dissolved was prepared. This liquid was sterilized by filtration through a filter having a pore size of 0.22 μm.

10 g of the powder and 3.5 mL of the liquid were placed in the inner container (sterilized with ethylene oxide gas) shown in FIG. 1, aseptically contained in an autoclave-sterilized outer container, and the outer lid was closed. Thereafter, the kneading container was set on “Spincle” (trade name, manufactured by Morita Tokyo Seisakusho) and kneaded for 50 seconds, whereby a uniform paste-like kneaded product was obtained.

The upper and lower cover members of the inner container were removed, and a luer lock was screwed into the inner container body as shown in FIG. 9, and an extruded member was inserted from the opening on the opposite side. Inner diameter 2.0mmφ, length 40m
m injection needle (manufactured by Tochigi Seiko Co., Ltd.) was attached to the syringe. When the extrusion member of this injector was pushed in and the paste was discharged from the needle tip, the paste could be discharged very smoothly.

Further, when a strength test and a sterility test were performed on the extruded paste, the results as described in Examples of Table 1 were obtained. The strength test was measured in accordance with JIS T6602 “Dental zinc phosphate cement”. However, the specimen was a cylinder of 7 mmφ × 14 mmL, immersed in the simulated body fluid shown in Table 2 for 7 days, taken out and measured while wet. The loading speed was 0.5 mm / min, and an Instron Model 4455 tester was used. The sterility test was performed according to the “Sterility Test Method” of the Japanese Pharmacopoeia General Test Method.

(Comparative Example) For comparison, the same powder and liquid as in the example were put into a commercially available medicated mortar and kneaded with a pestle. The obtained paste was subjected to a strength test as in the examples. Table 1 shows the results.

[0044]

[Table 1] (*) In the strength test, there was a significant difference in the t-test (risk rate 5
%)

[0045]

[Table 2]

[0046]

The kneading container of the present invention is a double container comprising an inner container for holding powder and liquid and an outer container for detachably housing the inner container, and the relative positions of the outer container and the inner container. A lock mechanism that does not change is provided, so that revolving rotation and rotation are simultaneously applied to the outer container containing the inner container, or vibration is applied so that the powder and liquid in the inner container can be kneaded, Aseptic mixing of powder and liquid, and
It can be performed simply and conveniently. Further, the injector of the present invention has a configuration including the inner container body, the injection member, and the push member, so that the inject member and the push member are attached to the inner container body containing the kneaded material, and the injector is left as it is. Therefore, the kneaded product can be aseptically and easily injected into the body.

[Brief description of the drawings]

FIG. 1 is a front sectional view showing an example of a kneading container of the present invention.

FIG. 2 is a partially sectional front view showing an outer container of the same kneading container.

FIG. 3 is a partially sectional front view showing the inner container body of the same kneading container.

FIG. 4 is a front view of the lower cover member in a partially sectional view.

FIG. 5 is a bottom view of the same lower cover member.

FIG. 6 is a sectional view showing an example of an injection member used for the injector of the present invention.

FIG. 7 is a sectional view showing another example of the injection member.

FIG. 8 is a partial cross-sectional view showing an example of a luer lock for mounting an injection needle used in the injector of the present invention.

FIG. 9 is a partially sectional front view showing an example of the injector of the present invention.

FIG. 10 is a front view showing another example of the kneading container of the present invention, which is a partial sectional view of an inner container.

FIG. 11 is a front view of the inner container body in a partially sectional view.

FIG. 12 is a front view of the lower cover member in a partially sectional view.

FIG. 13 is a front view of a stopper provided on the same inner container as viewed in partial cross section.

FIG. 14 is a partially sectional front view showing another example of the injector of the present invention.

[Explanation of symbols]

1 ... kneading container, 2 ... outer container, 3 ... outer container body, 4
... outer lid, 10 ... recess (locking mechanism), 11 ... inner container, 12 ... inner container body, 13 ... upper cover member, 1
4 ... lower cover member, 15 ... protrusion (lock mechanism),
20 ... injection member, 21 ... base, 22 ... injection pipe part,
23 ... injection member, 24 ... base, 25 ... injection pipe part,
26 ... luer lock, 27 ... base, 28 ... mounting part,
29 ... injector, 30 ... extrusion member, 41 ... inner container,
42 inner container body 43 upper cover member 44
... lower cover member, 45 ... stopper, 46 ... locking part, 54 ... locking edge part, 61 ... injector, 62 ... luer lock, 63 ... base part, 64 ... mounting part, 65 ... Extrusion members.

 ────────────────────────────────────────────────── ─── Continued from the front page (72) Inventor Nobuyuki Asaoka 2270 Yokoze, Yokoze-cho, Chichibu-gun, Saitama F-term in the Medical Materials Center, Mitsubishi Materials Corporation 4C060 LL13 LL20 4C066 AA10 BB01 CC04 DD08 EE14 FF04 FF05 JJ05 LL30 4C081 AB04 AC04 BA14 CF011 CF021 DA11 DA13 DC12 EA05

Claims (8)

[Claims] 1. A double container comprising an inner container for storing a powder and a liquid and an outer container for detachably housing the inner container, wherein the outer container for accommodating the inner container is revolved and rotated. A kneading container for kneading the powder and the liquid in the inner container by simultaneously applying or applying vibration, wherein the kneading container has a lock mechanism that does not change the relative position between the outer container and the inner container. And the inner container is provided
An inner container body having a first opening for discharging the kneaded material and a second opening into which the pushing member is inserted, and a first and a second for detachably sealing each of the first and second openings. 2. A kneading container for aseptic kneading, comprising: 2. The locking mechanism according to claim 1, wherein the locking mechanism comprises a recess formed on the inner bottom surface of the outer container, and a projection provided on one of the cover members of the inner container and capable of being fitted into the recess. The kneading container according to claim 1. 3. A locking portion is provided on an outer surface of the inner container body, and is screwed and externally fitted to a cover member having the projection formed thereon, and the cover member is locked by the locking portion. 3. The kneading container according to claim 2, wherein a stopper is provided to prevent the stopper from loosening and moving out of the inner container body. 4. A structure in which the cover member on which the projection is formed is screwed and fitted to the inner container body, and the cover member and the stopper are screwed in a reverse screw relationship. The kneading container according to claim 3, characterized in that: 5. The inner container body of the kneading container according to any one of claims 1 to 4, a base attached to the first opening side of the inner container body, and an injection extending from the base. An injector comprising: an injection member having a tube; and a pushing member inserted through a second opening of the inner container body. 6. An inner container body of the kneading container according to any one of claims 1 to 4, a base attached to the first opening side of the inner container body, and an attachment capable of attaching an injection needle. An injector comprising: a luer lock having a portion; and a pushing member inserted through a second opening of the inner container body. 7. The injector of claim 6, further comprising a needle attached to the luer lock. 8. A sterilization apparatus comprising: the kneading container according to claim 1; and a kneading apparatus main body that simultaneously performs revolving rotation and rotation on the kneading container. A kneading machine for kneaded material production.