JPS61501552A - A device for preparing injectable drugs - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Equipment for preparing drugs for injection Medications for injection are stored in ampoules sealed with a special self-sealing stopper made of rubber. It is usually supplied in a sealed package in a measured amount. This allows the user to drug can be drawn up without the risk of coming into contact with the drug, but the ampoule must be placed upside down. Even if you hold the needle upright and insert the needle from below, there may be a very small amount of air inside the needle. It's normal to feel nothing but ki. 1. To prevent drugs from contaminating the environment. The air must be pushed out with great care. The operation is a certain way It can be done in a powder form, but the drug must be dissolved in distilled water. Contaminants may be present if they consist of two components that must be mixed immediately before injection. It is difficult for K to perform this operation in order to avoid contamination. in such case Use a syringe needle filled with distilled water or one drug with a powder or other type of needle. empty the syringe and dispense the mixture. You have to shake it well and draw it into the syringe, then push out the harmful air. . This operation is time consuming and dangerous. Because in the ampoule By injecting liquid, the volume of air inside the cylinder decreases, so the pressure This is because the air and droplets will be forced out along the needle. be. To avoid this, the liquid is injected into the ampoule as quickly as possible. K to force air to be sucked out of the ampoule.

Liquid is usually injected by the pumping motion of the syringe's piston.

This problem itself is not new, and to solve it The septa of both compartments are broken by some means immediately before injection. An ampoule with a temperature of K such that

See, for example, Danish Patent Specification No. 115.655.

Special syringes have also been made to facilitate the mixing process. For example, See Permit No. 125.525.

However, it is troublesome to pack drugs in these containers. Also, such a The complex structure of samples and syringes makes them expensive to manufacture. . A simple solution to that problem is proposed in U.S. Patent Specification V 2.494.456. This is accomplished by using a "double flask" as proposed. but However, it is troublesome to fill the double flask with drugs, and one of the ingredients is distilled water. If there is, packing will be a waste.

Equipment used by hospital personnel to dispense injectable medications includes: Various requirements must be met.

The equipment must be compatible with regular ampoules and disposable syringes. Must be.

These devices should be used for the drug itself so that they can be discarded after one use. It has to be something that can be manufactured at a very low cost compared to other products.

The operator cannot place the solvent into the ampoule, shake the ampoule, or inhaling the mixture and pushing the noxious air into the area where the injection is performed without risk of contamination. Must be able to perform complete operations, including loading and unloading. Those instruments are iris It should not be necessary to change the way things are done.

The device of the present invention has a cylindrical shape that satisfies all of these characteristics and is sealed with a self-sealing stopper. It consists of a hammer-length, bowl-shaped top with a neck, and a thin, bag-like bottom that is airtight. It is a book characterized by having means for preserving. Kana is low due to such a shape Its base expands even under overpressure.

When this device is attached, the ampoule filled with the drug is placed in the lower part. placed. The lower part is then laminated to the top. Already filled with solvent? Twist the hypodermic needle into the neck of the top and into the ampoule until the solvent is released. Injected into the pull. Air escaping from the ampoule is caused by the lower part of the ampoule. The high overpressure compresses the air so that it can be inflated and forced out through the neck of the top. does not occur. Next, shake the device until the drug is completely washed away and draw the solution into the syringe. I'm open. Before completely removing the needle from the neck stopper, make sure that the inside of the syringe is expel air.

This operation, apart from the trivial effort of first placing the ampoule in the device, It is understood that no special requirements are placed on the design of the syringe or ampoule. It will cost you money.

The top of this device must be transparent so the user can see what he or she is doing. and to prevent the self-sealing stopper from being pulled out along with the syringe needle. In this case, some measure must be taken to secure the self-sealing stopper. That is non- Almost one of the drugs that is always harmful, such as cytostaticum (cytosta-(i) cum), in other words, it is a drug that stops cell growth. The above safety measures should be taken during the dispensing, filling and preparation of drugs. (The injection itself should be given in a room where only the patient and the person administering the injection are present.) 2. Contact with extremely dangerous drugs, or Safety clothing must be worn by the person administering the injection to prevent inhalation of the substance. trout Keep the patient calm while being injected by a person wearing a mask and other safety clothing. Apart from that, it takes time to take the safety measures mentioned above. A bowl-shaped neck according to a variant of the invention has one or more holes in the neck and multiple passages. The valve is improved by multi-passage valve connecting the central hole where the hypodermic needle is provided. These safeguards may prove futile.

The number and dimensions of the holes in the neck must of course be in accordance with the specific medical use of the device. I have to do it. Typically, those holes connect this device to a blood vessel in the patient's arm. It must be possible to connect the "infusion device" to the pipe that will be connected. Them The tube is inserted into a vial containing saline or other liquid, and finally into a hypodermic syringe. It will be done. It is clear that this exemplary embodiment of the invention increases manufacturing costs; Therefore, the variant is only suitable for applications involving highly hazardous drugs; Solving medical problems that have not been satisfactorily solved so far Not only that, but the manufacturing cost is also ignored in proportion to the other costs associated with medical treatment ICs. can.

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

FIG. 1 shows an embodiment of the device of the invention.

FIG. 2 shows the +jiIIIiyr plane along line nn in FIG.

Figure 3 shows an isolated cross-section of the top of the device.

Figure 4 shows the inner neck ring with a self-sealing stopper fixed therein.

Figure 85 shows an enlarged section of the top of the modified example.

Figure 6 is Vl-VIilK of Figure 5? 99 shows a cross section of the top.

FIG. 7 shows the valve body.

FIG. 8 shows a cross-sectional view of the valve body that crosses the line ■-■ in FIG. 9.

FIG. 9 shows a cross section taken along line IX-IX in FIG.

FIG. 10 shows a cross-section of the top of the device with the valve body in place.

#! Figure 11 illustrates the use of the embodiment of the invention shown in Figures 5-10. This is a schematic diagram.

As shown in Figure 1, the device consists of a hemispherical top 1 made of transparent plastic. Ru. Above its top (a cylindrical neck 2 is provided; as shown in FIG. It has an annular protrusion 3 inside. The protrusion 3 has a neck portion shown in FIG. It is fitted into the corresponding #l14 of ring 5. The ring is pushed into the neck. The outer diameter of the ring is slightly larger than the inner diameter of the neck 2 in order to obtain elastic pressure when stomach. Due to its elastic pressure, the ring 5 is placed in the opening 7 of the top 1 and is self-sealing. Fix the stopper 6 of the material.

The protrusion 3 fitted into the groove 4 allows the subcutaneous injection to be inserted through the stopper 6. To prevent the stopper 6 from being pulled out when the firing needle is pulled out again, Identify par.

As shown in FIGS. 1 and 3, the top 1 has a flange 8, on which is provided with a cylindrical lip 9 for reinforcement. Pass the flange 8 through without tearing the tension. , and is made of a material elastic enough to fit tightly around the flange. The flanges of the bag-like thin-walled lower part 10 are attached and airtight. This is to fix it in the correct position. As shown in Figures 1 and 3, the top picture on the bottom A bead 11 is provided over the section to provide the necessary strength and elasticity.

As explained earlier, overpressure compressed air may escape from the inserted hypodermic needle. must be avoided. Therefore, at the bottom of the lower IIs minute 100, the pressure increases A folded portion 12 is provided so as to be able to expand when the device is opened. Bend part shown Although it can be expanded in many other ways other than by dipping, If the bottom is made by It has the advantage that it can be pulled out loosely from the mold parallel to its axis. Ru. The number of folds is a secondary issue. The number of folds is shown as 4 in the figure. However, the possible volume [inflation must be equal to the volume of a regular hypodermic syringe] is.

The illustrated embodiment of the top part 1 can easily be made by injection molding. Separation of mold parts and A draft angle to allow removal of the shaped article is not shown. I mean, This is because the injection molding method itself is well known and is not a component of the present invention. be.

The neck 2, mainly at the top, can be as short as the strength of the ring allows, but it is inserted If the air in the syringe is emptied after the hypodermic needle is withdrawn from the ampoule, e.g. sufficiently so that it cannot unintentionally pierce the thin wall at the bottom when It has to be long. The dirt is shown in Figure 3. In the diagram, inserted The hypodermic needle is placed in the maximum oblique position allowed by a given neck length, i.e. This is indicated by a broken line.

Figures 5 to 10 show that the user prepares the drug, fills the hypodermic syringe with the drug, and Dispense the drug with confidence that the drug has not come into contact with anyone other than the patient. 2 shows a variant of the device that allows the agent to be injected; This deformation An example is the self-sealing stopper 5, which has not been used so far, and the multi-passage valve. The neck part 2 of the hemispherical top part 1 is improved. From Figures 5 and 6, neck 2 The inner cylindrical ring 13 of the short tube 17. ? 8.19 holes 14, 15.16 Ni:i! You can see how it is tied. As shown in Figure 6, those three The angle between the axes of the short tubes is about 40 degrees. In this case, the valve body 20 is a special type. If it is made by It can be seen that the subsequent connection of the valves is possible by simply setting two valve bodies as shown in FIG. It will cost you money. For example, connecting a saline bottle to a patient, subcutaneous injections container and the ampoule containing the dangerous drug previously placed in this device. A connection between the hypodermic syringe and the tube to the patient is possible.

The valve body 20 has a grip 21, a housing disc 22, and a cylindrical portion 23.

The outer diameter of this cylindrical portion corresponds to the inner diameter of the neck ring 13. Cylindrical portion 23 In other words, is it a short tube that extends sufficiently wide at 80 degrees? Between 7, 18 and 19 A circumferential groove is provided that extends just enough to make the two-by-two communication connection.

The cylindrical part also has an axial through hole 25 terminating in a radial through hole 26 Ru. The axis of the radial through hole is 120 degrees relative to the radius at the middle of the groove 24. form an angle of degrees. Comparing FIG. 6 and FIG. 8, the valve body 20 in one position is Communication connections between openings 15 and 16 and between opening 14 and axial through hole 250 and in another position the valve body 20 establishes a communication connection between the openings 14 and 15. You will see that.

FIG. 10 shows the hemispherical top 1 when the valve body 20 is in place within the neck ring 13. A cross section is shown. As shown in the figure, the cylindrical portion 23 has a valve body that is unintentionally pulled. A collar 23 can be provided to prevent tearing. The needle is in the axial direction is inserted neutrally into the through hole 25. Packed with dissolved drug as shown A normal ampoule containing Kf11 is placed in this device, and is also placed in front of the hypodermic syringe 29. is inserted into the opening. When the valve body 2o is in the position shown, the opening is , is connected to the axial throughbore and thus to the hypodermic needle 27. bottom side Since the wall of section 10 is thin, pinch the ampoule and press it against the hypodermic needle 27 to inject it under the skin. The injection needle 27'Jk seal can be removed and placed into the ampoule. next , mixing and injecting the drug and solvent as described above with reference to FIGS. 1-4. You can prepare a gun. Then, the valve body 2o is placed in the second position. Part 1 In position 2, the opening into which the syringe 29 is inserted (opening 1 in FIG. 4) can be connected to the opening to which the injection tube is fixed. The other end of the tube is For example, an "infusion device" K is connected to perform a drop in a blood vessel KA in a patient's arm. Now this Do not remove the syringe from the device first and avoid contaminating the surrounding area with unsuitable drug. The injection itself can be performed without

As shown in FIG. 6 and as explained above, the neck 2Fi has three openings. do. Among these openings, openings 15 and 16 are connected through grooves 24 (FIGS. 7 and 8). The opening 14 is connected to the axial through hole 25. this thing In the example described here, the injection tube connected to the opening 15 is opened. The injection tube can be filled with saline through the spout 16 and expelled from the injection tube prior to injection. K so that I can do it. Once the air is expelled and the valve body is returned to its original position, the injection tube will open. Can be cleaned by rapid flow.

This application of the device is illustrated in FIG.

FIG. 11 is a schematic diagram showing the function of the valve. The openings 14, 15 and 16 of the valve are respectively This connects the hypodermic syringe, the injection tube, and the tube leading the saline from the bottle. In addition to the injection tube The end portion of the KFi patient's blood vessel is connected to the drip device. In the first position of the valve body The groove is in the setting part 24, which connects the opening parts 14 and 15, and the radius is The directional through hole is located in the setting part 2B, and the syringe and the axial direction X through hole 25 are located in the setting part 2B. Connect the hypodermic needle inside. This setting allows you to fill the injection tube with salt water. and therefore air can be expelled. The drug is mixed in distilled water and shaken It is then sucked into a syringe. Then, the drug ampoule is inserted into the axial through hole. The hypodermic needle inside is pulled free and excess air is forced out of the syringe.

Here the valve body has a different configuration, i.e. the groove is at 24' and the radial through hole is at 26'. It is set to fall on the screen. This will close the entrance to the hypodermic needle and the saline tank. However, the injection tube at the opening 15 and the syringe at the opening 1B are connected. This allows the dissolved drug to be injected. Suppose the valve body is returned to its initial position. The injection tube can then be cleaned by rinsing.

The above explanation is an example of a neck valve designed to meet a special and most urgent need. This shows one way to design. Number of external openings and where to place them It is clear to those skilled in the art that it is necessary to change this in accordance with other medical considerations. Or maybe. Check the high spot or stop to determine the correct operating position of the valve body. It must be pointed out that well-known matters such as posting replies were not illustrated. stomach.

According to the present invention, the well-known "glove box" used for handling radioactive materials It can be seen that similar safety devices such as Rorou. However, 2. This device can be taken anywhere, and after use, i This device can be used to store drugs and In order to eliminate the need to wash hypodermic needles by putting them in and out of water, It is much easier to use than the FF.

1st peak--×I FTq, 10 Fiq, Pu1 international search report □ amum m PCT/DK85100025

Claims (9)

[Claims] 1. Prepare the injectable drug while the drug is in a container that prevents the drug from the ambient air For appliances that are used, a sturdy It has a top (1) for securing the thin-walled lower part (10) in an air-tight manner. means (8, 9), the lower part of which is shaped in such a way that even a slight overpressure causes expansion; A device for preparing an injectable drug, characterized in that: 2. Device according to claim 1, characterized in that it comprises fixing means (8) of the lower part (10). is a flange, the periphery of which is larger than the periphery of the lower part (10); A device characterized in that the upper edge of the portion (10) is provided with an elastic ped (11). Ingredients. 3. Device according to claim 1, having a cylindrical shape in which the ring (5) is placed. The top with the neck (2) presses against the self-sealing stopper (6), the ring of which presses against the groove (4) A device characterized in that the protrusion (3) on the inside of the neck part engages in the groove. Ingredients. 4. The device according to claim 3, which pierces the stopper (5). The neck (2) is so that the hypodermic needle cannot penetrate the lower part (10). A device characterized by sufficient length. 5. The device according to claim 3, wherein the cylindrical neck (2) has a valve body (20). The valve body is constructed as a multi-passage valve with a neck (2 ), and one or partial communication between the openings and the axial through hole (25) of the valve body. A through connection is made, which includes a hypodermic needle (27) protruding into the hemispherical top (1). A modified instrument provided. 6. A device according to claim 5, containing a cylindrical valve body (20) and a short tube. Openings (14, 15 and 1) in the neck (2) by (17, 18 and 19) 6) A device characterized by an inner cylindrical neck ring (13) terminating in. 7. The device according to claim 6, wherein the valve body (20) is arranged along a portion of the surface. having a circumferential groove (24) and an axial through hole (25); A hypodermic needle (27) is placed in the hole and the upper end of the axial through hole (25) A radial through hole (26) is provided to ensure that the valve body is in place within the neck ring (13). Axial through holes and grooves (26) accommodate short tubes (17, 18 and 19) when An apparatus characterized in that it is adapted to do. 8. The device according to any one of claims 1 to 7, the top of which is transparent. A device characterized by being made of transparent materials. 9. A device according to claim 1, characterized in that the lower part (10) has an axis along its axis. Device characterized in that it is provided with parallel folds (12).