WO1984003830A1

WO1984003830A1 - Container for mixing bone cement

Info

Publication number: WO1984003830A1
Application number: PCT/JP1984/000174
Authority: WO
Inventors: Shinkichi Himeno
Original assignee: Yougengaisya Youshinkaihatsu
Priority date: 1983-04-06
Filing date: 1984-04-06
Publication date: 1984-10-11

Abstract

A container for mixing bone cement is used when an artificial joint is secured to living tissue. This container for mixing bone cement is flexible and also has a structure which permits hermetic sealing, so that it enables mixing under a state in which atmospheric air is excluded. Thus it is possible to prevent the inclusion of vacuoles, infection with bacteria, and the generation of odors in the operating room, which are attributable to conventional mixing in air, and it is possible to ensure that an artificial joint remains secured for a long period of time.

Description

Specification

Bone cement mixing container

Technical field

TECHNICAL FIELD The present invention relates to a bone cement mixing container used for fixing a prosthesis to bone during artificial joint replacement.

Background technology

With the rapid growth of the aging population, the number of patients complaining of musculoskeletal disorders, joint pain and dysfunction, is increasing. If joint disorders are severe, replacement surgery with artificial joint prostheses is performed. The replaced joints cover almost all joints, including the hip joint, knees, legs, shoulders, elbows, and so on. During surgery, the deformed joint is first excised, and then the cancellous bone in the medullary cavity is removed. This leaves a solid pipe-like cortical bone. The fluid bone cement is poured into the medullary cavity, which is the lumen of the pipe, and the root of the prosthesis is then introduced into the medullary cavity. Due to the solidification of the bone cement, the root of the prosthesis is fixed to the pipe-shaped cortical bone, and the head is articulated with the corresponding articular cartilage or a similarly fixed prosthesis. Become. .

For bone cement, methylmethacrylic resin is mainly used at present. Fluid bone cement can be obtained by adding a liquid monomer liquid to a powdery polymer and mixing the two well. .

Explaining the conventional bone cement mixing system, as shown in Fig. 1, powder polymer 1 is packed in a bag 2 made of polyethylene by sterilization and packed tightly by heat sealing. I was Monomer liquid 3 is highly corrosive

o: W1PO A glass ampoule was contained in an ampoule. In use, first break a part of the bag 2 and transfer the powder polymer 1 to the mortar 5 which is a mixing container, then cut the ampoule 4 and sprinkle the monomer solution 3 on the powder polymer 1 in the mortar 5 . The powder polymer 1 and the monomer liquid are mixed by stirring using the mixing spatula 6.

The mixing of 3 was performed to obtain a fluid bone cement.

As described above, the conventional mixing of bone cement has been performed while being exposed to the air, and thus has the following disadvantages.

(1) Thousands to tens of thousands of suspended bacteria per cubic rice are floating in the air. Mixing in a mortar while exposed to the air necessarily implies airborne bacteria in the bone cement.

Bacterial growth after surgery is very intractable and often even leads to removal of the prosthesis. This can leave severe dysfunction, which can be extremely disastrous.

(2) Fluid bone cement is very viscous. For this reason, mixing with a spatula in the air will always introduce air bubbles. X-rays taken after joint replacement surgery performed using bone cement mixed by conventional methods show numerous small and large bubbles in the solidified bone cement. Such a vacuolar defect causes the bone cement to have a weaker strength, easily break under load and lose its supporting capacity, and cause the prosthesis to loosen or sink.

(3) It is known that the monomer liquid is volatile and has a strong pungent odor, and there is a risk of liver dysfunction and carcinogenesis if inhaled for a long time. With conventional mixing systems, air pollution of monomer liquid components is almost completely unprotected.

OMPI WIPO Disclosure of the invention

The present invention has been made to overcome the above-mentioned drawbacks of the conventional bone cement mixing system. For the purpose of the present invention, by performing mixing in a state where air is shut off, a clean and strong bone cement mixing system is provided. It is an object of the present invention to provide a bone cement mixing system capable of producing a patient under a comfortable operating environment. For this reason, the artificial cement prosthesis is a bone cement used for fixing a bone to a bone, and has a structure that is flexible and can be sealed in a mixing container. A mixing container was used.

Hereinafter, embodiments will be described in detail with reference to the drawings.

Brief explanation of drawings

Figure 1 is an illustration of a conventional bone cement packaging and mixing system.

FIG. 2 is a diagram showing an example in which an injection port is extended from a container body and a rubber stopper is used at an end.

FIG. 3 is an explanatory view of the same use condition.

FIG. 4 is a diagram showing an example in which a stopcock is used at the end of the injection port. .

Fig. 5 shows an example where a rubber plug is embedded in the container wall.

FIG. 6 is a diagram showing an example which also serves as an injection container.

FIG. 7 is an explanatory view of the same use state.

FIG. 8 is a diagram showing an example of clipping the inlet base.

FIG. 9 is a diagram showing an example in which the container wall has a double structure and also serves as an injection container.

FIG. 10 is a diagram showing an example in which a conduit is provided inside the container.

FIG. 11 is a view showing another example in which a conduit is provided inside the container. Best form to carry out the invention

As shown in Fig. 2, the injection part 12 is extended from the polyethylene container body 11 and its end is sealed with a rubber stopper 13.The powder polymer 1 is already in the container 11 together with sterilizing gas. Sealed. At the time of use, as shown in Fig. 3, a syringe needle 14 connected via an adapter 15 to a negative pressure suction tube 16 provided at the operating theater is provided in a container with a rubber stopper 13 Insert. As a result, the gas in the container 11 is sucked to the outside, leaving only the powder polymer inside.

When sufficient aeration has taken place, remove needle 14 once. At the time of removal, since the rubber stopper 13 is used, the puncture port of the injection needle 14 is naturally closed due to the elasticity of the rubber, and the internal airtight condition is maintained. Then, the monomer solution 3 in the sample 4 is sucked up into the syringe syringe, and after attaching the injection needle 14, the syringe is similarly inserted through the rubber stopper 13, and the monomer solution is injected into the container 11. Remove the injection needle 14. Since the container 11 is made of flexible polyethylene, the powder polymer and the monomer liquid inside are sufficiently mixed by rubbing with both hands from the outside of the container 11. After mixing, part of the container 11 is opened with scissors or the like, and the internal fluid bone cement is transferred to a separately prepared cylinder for intramedullary injection, and injected into the medullary cavity.

In this embodiment, since all the exchange of substances such as exhaustion and injection of the monomer liquid with the outside of the container is performed through the injection needle 14 inserted into the rubber stopper, the outside air is completely shut off. Thus, it is possible to mix bone cement, and to obtain a fluid bone cement free of airborne bacteria and air bubbles without odor. Maichi In addition, in this embodiment, since the packing container for the powder polymer is also used as the mixing container, there is no need to transfer the powder polymer from the conventional packing container 2 to the mixing container, and the outside air between the parentheses is removed. Can be avoided.

FIG. 4 and FIG. 2 show an embodiment in which a stopcock 20 is provided in the rubber stopper 13) of FIG. 2 so that the cock 21 can be opened and closed freely. The cock 21 is fixed to a rotor 22 having a passage 23 inside. Only when the cocks are parallel do the inside and outside of the container 11 communicate via the passage 23. By making the hook a right angle, the inside of the container 11 and the outside world are shut off. In this embodiment, the injection needle 14 is unnecessary, and after connecting the suction tube 16 with the adapter 15 to the open end 24 and opening the stopcock, the inside of the container 11 is evacuated. It is. After sufficient degassing, the stopcock is closed, a syringe syringe sucking up the monomer solution is connected in place of the suction tube 16, and the stopcock 20 is opened to inject the monomer solution. After closing the stopcock 20, bone cement may be similarly mixed. Fig. 5 shows another embodiment, in which a rubber stopper is extended from the container body as shown in Fig. 2. The rubber stopper is provided not on the end of the injection port 12 but on the wall surface of the container body 11. In this example, similarly to FIG. 3, air-tight bone cement mixing is performed by inserting the injection needle 14 into the central recess 31 of the rubber plug 30.

FIG. 6 shows another embodiment, in which the container body 11 has a relatively large opening 40, which is closed by a plug 43. A thin passageway 44 is provided in the plug 43 ′), and communicates with the outside via a tube 42 and a stopcock 41. Also in this embodiment, the bone cement can be mixed under the air cutoff by the same operation as the embodiment of FIG. Further, in this embodiment, After mixing of the bone cement, the plug 43 was removed and the bone was replaced as shown in FIG.

Attach the intramedullary injection nozzle 50. Pressing the container body 1 1 by hand etc.

¹ ), Fluid bone cement 7 Blow out from the nozzle tip. This allows the bone marrow

Sufficient bone cement can be filled to the deep part. In the present embodiment, since the container is also a powder polymer packaging container, a bone cement mixing container, and an intrathecal injection container, the mixing container is used for the mixing container, or the mixing container is used for the injection container.

The operation of transferring bone cement, such as slabs, can be reduced, and the

Bone cement can be protected from innocence.

As described above, in any of the embodiments, the bone cement

Exposure to bones is minimal or nil ').

Also in the example, it can be performed in a completely airtight manner.

This prevents contamination of bone cement by airborne bacteria, lowers the strength of bone cement due to air bubbles, and prevents the irritating odor of the monomer solution, providing a clean and strong bone cement in a comfortable operating environment. Can be created below.

FIG. 10 shows an embodiment in which a monomer liquid conduit is provided inside the container.

The container body made of polyethylene is packaged with polymer powder (:

It is sealed by a rubber stopper B at the tip of the monomer reservoir E extending from the main unit A. Rubber stopper B Due to its elasticity, degassing operation and monomer liquid

Even if the injection needle is inserted during injection, the insertion hole after pulling out is closed naturally,

It is always kept airtight. From the monomer pool E, the container

A monomer liquid conduit D extends inside. Inject the monomer liquid into conduit D

The outlet of the monomer liquid F whose diameter increases as the distance from the rubber stopper B increases.

OMPI

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Are provided everywhere.

Before use, first insert the syringe needle connected to the suction tube into the rubber stopper B to remove air from the container. Once the needle is removed, the monomer solution is sucked into the syringe, the needle is pierced again into Rubber B, and the solution is injected. The monomer liquid is guided to the conduit D from the liquid reservoir E, and penetrates into the surrounding polymer powder through the outlet F. At this time, the diameter of the ejection hole F is larger toward the end where the injection pressure is lower, and the outflow resistance is small, so that the outflow of the monomer liquid from the conduit is uniform to the whole. Become. In other words, if there is no conduit D, the monomer liquid must gradually permeate from the rubber stopper B end to the other end, so that the monomer liquid is excessive in the proximal part, while the polymer powder is still in the distal part. The force that is likely to cause non-uniformity if left unmixed as it is, because if there is a conduit D, it will only penetrate the liquid and only need to go around from the conduit D located at the center of the container to the periphery, so the necessary penetration distance It can be overwhelmingly short, and it is easy to mix quickly by this amount.

FIG. 11 shows another embodiment, in which a plurality of conduits having different lengths and different diameters are provided. In order to maintain a constant outlet pressure of the monomer liquid from the end G of the conduit, the diameter of the short conduit D 1 is small and the diameter of the long conduit D 2 is large and moderate; The outflow resistance of each conduit D1 to t) 3 is constant. For this reason, the same amount flows to each of the conduits D1 to D3 through the pool E of the monomer liquid injected from the injection needle inserted through the rubber stopper B ') and the polymer powder Mixing is quick and uniform.

In any of the embodiments, the presence of the conduit allows the monomer-liquid container body

O PI

wi? o — O —-Since the polymer powder penetrates from anywhere in A, the penetration distance is shortened, and uniform mixing can be obtained promptly.

Note that the present invention is not limited to the embodiment shown here.

Although the container body is made of polyethylene in the embodiment, any other material may be used as long as it has flexibility and can withstand corrosion of the monomer liquid. The flexibility and strength of each part of the vessel, degassing, pouring, and mixing and stirring can be set appropriately. Instead of a rubber stopper, a river may be used as long as it is a corrosion-resistant substance that can naturally close the puncture port when removing the injection needle. Composite materials may be used depending on the strength and resistance.

In the embodiment, the case where the rubber stopper / stopcock is used as the structure of the sealable inlet is described. However, the present invention is not necessarily limited to this case.For example, two one-way valves for deaeration and injection are used. May be used. Although it is somewhat inconvenient, as shown in Fig. Δ ·, even if the structure is such that the inlet 12 is simply extended from the container body 11, the injection used for degassing and injection The inflow of air from the insertion port of the needle i4 is prevented by applying forceps 60 or the like to the base of the injection port 12 and clipping, thereby achieving the object of the present invention! : Yes. Further, for example, the container body 11 is constructed by using a rubber film that can naturally close the puncture of the injection needle, and the inner surface thereof is covered with a polyethylene film having a corrosion property. If the structure is such that the stopper 30 is spread over the entire container, even a simple rectangular container body can serve the purpose of the present invention. In short, it is only required that the material has corrosion resistance and has a structure capable of maintaining airtightness during the degassing, pouring, and mixing processes.

Examples: ') Preferred mixing container and powder polymer packaging volume Although an example is shown that also serves as a container, it is possible to transfer powder polymer from a conventional powder polymer packaging container by providing a sealable powder polymer inlet in the mixing container. Good.

In the embodiment (FIGS. 6 and 7) which also serves as an injection container, the compression is performed by hand. However, as another application by the present inventors, the container body 11 is placed in a rigid outer grain container. The fluid bone cement 中 in the flexible container 11 may be extruded by mounting and increasing the internal pressure of the space between the two containers. Also, as shown in Fig. 9, the container wall has a double structure, and in both cases, pressurized fluid is injected into the space 70 between the flexible inner wall 71 and outer wall 72 through a pipe 73. The fluid bone cement 7 in the inner wall 71 can be extruded. -In this example, when mixing bone cement at the operating theater, the sterile gas was removed, and then the monomer solution was injected.However, the method is not limited to this.包装 If pre-packaged in the evacuated state, there is no need to perform deaeration work at the operating theater, and only the monomer solution needs to be injected, which simplifies the work.

Further, in the embodiment shown in FIGS. 10 and 11, it is preferable to make the amount of the monomer liquid ejected from everywhere as uniform as possible, but if the amount of the ejected liquid is allowed to be somewhat uneven, For example, in Fig. 10 (a) simply providing a tube-shaped conduit without a side hole, (Q) the size of the side hole, the proximal and distal areas are equal, and in Fig. 11 (c) the length The diameters may be different but may be the same. The shape of the container body A and the reservoir E can be freely designed according to the purpose, such as cylindrical and rectangular. In addition, container body A and conduits D, D 1 ~! 3) The material has a certain degree of flexibility

O PI WIFO

· ^ Rivers may be used as long as they can withstand the decomposition of the monomer liquid.

Industrial availability

The bone cement mixing container of the present invention is mainly used for joint reconstruction using an artificial prosthesis in the field of orthopedic surgery.

OMPI

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Claims

The scope of the claims

1) A bone cement mixing container characterized by having a flexible and sealable structure in a bone cement mixing container used for fixing an artificial joint replacement to bone.

2) The bone cement mixing container according to claim 1, wherein a sealable injection part is provided.

3. The bone cement mixing container according to claim 1, wherein the sealable injection part is protruded from a container body.

4) The bone cement mixing container according to any one of claims 1 to 3, wherein a rubber stopper is used for the sealable injection part.

5) The bone cement according to any one of claims 1 to 3, wherein a stopcock is used for the sealable injection part, and the cock is opened and closed by rotating the cock. G mixing container.

6) The bone cement mixing container according to any one of claims 1 to 5, wherein the mixing container serves also as a container for injecting into the bone marrow cavity.

7) The bone cement mixing container according to claim 6, wherein the container wall is doubled and a gap is provided therebetween.

8) The bone cement mixing container according to any one of claims 1 to 4, wherein the mixing container also serves as a packaging container for the bone cement polymer powder.

9) Patent application characterized by providing a monomer liquid conduit inside the mixing vessel

Item 9. The bone cement mixing container according to Item 1 to Item 8.

10) A C, M-IV IPO. 10. The bone cement mixing container according to claim 9, wherein

1 1) The bone cement mixing container according to claim '9, wherein a plurality of conduits having different lengths are provided.

OMPI people