JPH0653153B2 - Method for storing and treating porous artificial bone material - Google Patents

Description

TECHNICAL FIELD The present invention relates to a method for storing a porous artificial bone material used for treatment of dental, oral surgery, orthopedic surgery and the like. More specifically, the present invention is capable of reliably storing aseptic a granular porous artificial bone material used by mixing with physiological saline for filling a bone defect portion. Occasionally, it relates to a storage method and a processing method that allow it to be easily mixed with saline.

2. Description of the Related Art In the case of prosthesis of a defective bone in the fields of dentistry, oral surgery, orthopedics, materials for prosthesis such as autologous bone, ceramics, plastic and metal are usually treated with physiological saline. In vivo.

In this case, the material used is aseptically stored and taken out as it is, or after nonsterilely stored one is sterilized, it is impregnated with physiological saline and treated. Even if it can be easily treated, the porous one takes a considerably long time to completely infiltrate the physiological saline solution to the inside, and at the time of transferring it to another container, it also permeates. There is a problem that it is contaminated during the depressurization treatment for acceleration, and if the air is filled in the living body while remaining in the living body, invasion of living tissue into the living body is difficult to occur and the healing is delayed. is there.

In order to solve such a problem, it is considered that the porous material and physiological saline are mixed in advance and then stored aseptically. However, in this case, salt is crystallized during storage. It is not practical because it may be separated or the porous material may be altered.

Therefore, a porous material, in particular, a granular porous artificial bone material can be reliably stored in a sterile state, and as a mixture with physiological saline when necessary, a storage method and a treatment method that can be provided for use are Was not known.

Problems to be Solved by the Invention An object of the present invention is to rapidly mix a sterilized and stored porous artificial bone material with physiological saline in a storage state without transferring it to another container, Moreover, it is an object of the present invention to provide a storage method and a treatment method which allow physiological saline to permeate the pores of the porous artificial bone material and can be used as they are after opening.

MEANS FOR SOLVING THE PROBLEMS The present inventors have stored a porous artificial bone material, particularly a granular porous artificial bone material, which is mixed with physiological saline and filled in a bone defect site, in a safe and reliable aseptic state. In addition, as a result of intensive research, in order to develop a storage method and a processing method that can be rapidly mixed with physiological saline without transferring another container when necessary, as a result, it has a stopper made of a specific material. It has been found that the object can be achieved by storing in a container under reduced pressure or vacuum, and the present invention has been completed based on this finding.

That is, the present invention stores a porous artificial bone material in a pressure-resistant container leaving an excess space, and in a state where the inside of the container is kept under reduced pressure or vacuum, at least a part of the stopper is made of a material that can be inserted. In the storage method of the porous artificial bone material which is airtightly closed with a seal and the mixing treatment of the porous artificial bone material and the physiological saline, the porous artificial bone material is stored in the pressure resistant container with an extra space left, Is hermetically sealed with a stopper made of a material at least a part of which can be inserted under reduced pressure or vacuum, an injection needle is inserted into the stopper, and physiological saline is introduced through the injection needle. The present invention provides a mixing treatment method in which a porous artificial bone material is quickly penetrated into the pores.

In the method of the present invention, the container used for storage is important. This container is composed of a main body formed in a box shape, a cylinder shape, a bottle shape, and the like, and a stopper for sealing the opening.

It is necessary for the container body to be formed of a material having a strength sufficient to withstand the atmospheric pressure of the outside when the inside of the container is closed under reduced pressure or vacuum. Examples of such a material include glass, metal, and plastic. This container body can have any shape as long as it can form an airtight closed state together with a stopper used in combination with the body, such as a box shape, a cylinder shape, a bottle shape or a horizontally long shape, a vertically long shape, etc. It can be anything.

Next, the stopper for sealing the opening of the container body is such that the needle can be penetrated so that the physiological saline solution to be mixed with the porous artificial bone material of the content can be supplied by the syringe at the time of use. It must be made of material. As such a material, a material having elasticity to some extent, such as natural rubber or synthetic rubber, is suitable. The stopper may be entirely made of such a material, or only the portion penetrating the injection needle may be made of such a material, and the other portions may be made of another material such as metal or plastic.

Next, an embodiment of the method of the present invention will be described with reference to the accompanying drawings.

FIG. 1 is a cross-sectional view showing a state in which a granular porous artificial bone material 3 is stored in a storage container composed of a glass cylindrical main body 1 and a synthetic rubber cap 2. It is filled with an extra space 4 so that saline can be introduced. The inside is depressurized to a pressure of 100 mmHg or less, preferably 10 mmHg or less.

When the artificial bone material stored in such a state is used, an injection needle is pierced through the synthetic rubber cap 2 and a required amount of physiological saline is introduced into the container through the injection needle.
Since the inside of the melt is under reduced pressure as described above,
The physiological saline can be easily introduced, and the porous artificial bone material can be quickly infiltrated into the pores to easily prepare a mixture of the porous artificial bone material and the physiological saline.

The mixture thus prepared can be filled into a bone defect portion in a living body by using a usual method.

FIG. 2 is a sectional view showing an example of a storage container in which a part 2'of the cap is made of synthetic rubber and the other parts are made of metal.

FIG. 3 is a cross-sectional view showing an example of a storage container with an injector improved so that a mixture of a granular porous artificial bone material and physiological saline can be directly injected into a bone defect portion during use. ,
The container body is composed of a cylindrical portion 1 and an injection slider 5 which also serves as a bottom portion during storage, and a spacer 7 is provided between the bottom surface of the cylindrical portion 1 and a flange 6 provided at an end portion of the slider 5.
Is inserted and fixed so that the slider 5 does not move during storage. Since the slider 5 is slidably and airtightly fitted in the lower opening of the cylindrical portion 1, it is mixed with a physiological saline solution supplied through an injection needle penetrating the stopper 2 during use. The granular porous artificial bone material is extruded from the upper opening of the cylindrical portion 1 by pushing the slider 5 after removing the plug 2 and the spacer 7, and can be directly applied to the bone defect portion.

Effects of the Invention According to the method of the present invention, aseptically stored porous artificial bone material is easily and quickly mixed with physiological saline in a container at the time of use, and up to the pores of the porous artificial bone material. Since physiological saline can be penetrated, it is possible to prevent contamination that may occur during transfer of the container or during the mixing operation.
Moreover, there is an advantage that the time for filling the bone defect portion can be remarkably shortened.

EXAMPLES Next, the present invention will be described in more detail with reference to Examples.

Example In a cylindrical storage container having a diameter of 20 mm and a height of 30 mm having the structure shown in FIG. 1, porous hydroxyapatite granules (average particle size 2 mm) having pores with an average pore size of 10 μm were made to occupy a volume of 60%. After filling until, the inside pressure is reduced to 10 mmHg,
Sealed with a synthetic rubber cap.

One month later, an injection needle was pierced through the cap, 3 ml of physiological saline was introduced therethrough, and after leaving it for about 1 minute, the cap was removed and the contents were taken out. As a result, a mixture of porous hydroxyapatite granules infiltrated with and physiological saline was obtained.

Comparative Example Approximately 5 porous hydroxyapatite granules similar to those used in the Examples
After storing cc in a glass container for 1 month, this was opened, transferred to a petri dish, and 3 ml of physiological saline was added. When allowed to stand as it was, even after 24 hours, the porous granules remained floating on the liquid surface of the physiological saline and the physiological saline did not completely penetrate into the pores.

[Brief description of drawings]

FIG. 1 is a sectional view showing an example of a storage container used in the method of the present invention and a storage state using the same, and FIG. 2 is a sectional view showing an example of a storage container having a stopper different from the container shown in FIG. Fig. 3 is a sectional view showing an example with an injector container. In the figure, reference numeral 1 is a container body, 2 is a stopper, 3 is a granular porous artificial bone material, and 5 is an injection slider.

Claims (2)

[Claims] 1. When storing a porous artificial bone material, the porous artificial bone material is stored in a pressure-resistant container while leaving an extra space, and at least a part of the artificial artificial bone material is needle-inserted under a reduced pressure or a vacuum. A storage method, characterized in that the container is hermetically sealed with a stopper made of a possible material. 2. In the mixing treatment of a porous artificial bone material and a physiological saline solution, the porous artificial bone material is stored in a pressure resistant container leaving an excess space, and the inside of the container is kept under reduced pressure or vacuum, At least a part is hermetically sealed with a stopper made of a material capable of being inserted into the needle, and an injection needle is inserted into the stopper, physiological saline is introduced through the injection needle, and pores of the porous artificial bone material are introduced. A mixing treatment method characterized in that it rapidly enters a part.