AN APPLIANCE FOR THE PREPARATION OF INJECTABLE MEDICAMENTS

Abstract: An appliance for the dissolution of medicaments in the form of dry matters and the absorption of the dissolved medicament into a hypodermic syringe with a subsequent emptying the syringe of air. The appliance consists of a hemispherical, transparent top section (1) with a cylindrical neck (2) in which a self-sealing rubber stopper (6) is seated and which has a circular collar or flange (8) for an elastic fastening of a thin-walled, bag-like bottom section (10) provided with a bead (11) securing an airtight connection with the top section (1) and with foldings enabling a volume expansion when the air-pressure in the appliance rises due to a liquid being injected into a drug-ampoule already placed in the appliance. Instead of being provided with a self-sealing rubber stopper the neck (2) can be improved to be a multi-channel valve with a valve body (13, 23) which in different positions gives conductive connection between apertures in its neck meant for the insertion of tubings, hypodermic syringes etc., said connection being mutual between the apertures or between them and an axial bore hole in the valve body where a hypodermic needle (27) is inserted.

Description: An appliance for the preparation of injectable medicaments Medicaments for injection are usually delivered in measured portions in ampoules closed with a special, self-sealing rubber stopper. By this the medicament can be sucked up sterilely and without risking that the user gets in touch with it, but even if the am¬ poule is held upside down and the syringe needle in¬ serted from below, there will usually be a little bit of air in the needle which must be pressed out with great care to avoid that the medicament contaminates the surroundings. It can be carried out with some practice, but it will be substantially more difficult to avoid contamination when the medicament is either a powder which has to be dissolved in distilled water or consists of two components which must be mixed im¬ mediately before the injection. In .this case the hypo¬ dermic syringe filled with distilled water or one of the medicaments must be inserted into an-ampoule with a powder or the other component, the syringe be e p- tied, the mixture be thoroughly shaken and sucked into the syringe, which next is withdrawn and emptied of pernicious air. This procedure is time-consuming and risky because the injection of liquid reduces the vo¬ lume of the air in the ampoule which again causes an excess pressure which forces air and drops of liquid to escape along the needle of the syringe. To avoid this the liquid is usually injected by a pumping move¬ ment of the syringe piston in order that the air is sucked out of the ampoule at the same rate as the li- quid is injected. The problem in itself is not new and to solve it has been proposed to make ampoules having one compartment for the medicament and another for the solvent and where the par¬ tition somehow is penetrated immediately before the in- jection, see for instance the Danish patent specifications no. 115 655. Special syringes ' to facilitate the mixing procedure have also been manufactured, see for instance the Danish patent specifications no. 125 525. However, such things throw the troubles on to the packing of the medicaments. Besides the manufacture of such special ampoules and syringes is rather expen¬ sive due to their complicated design. A simpler solu- tion of the problem is achieved by using a "double- flask" as proposed in US patent specifications no. 24 94 456, but here again the packing is complicated, and furthermore the packing is superfluous if one of components is. distilled water. utensils for the preparation of injectable medicaments by hospital staffs must fulfil the following demands: They must be usable in connection with the ordinary ampoules and disposable syringes. They must be so cheap to manufacture compared to the price of the very medicament that they can be destroyed after one single application. The operator shall be able to perform the complete pro- cess of injecting the solvent into an ampoule, shaking the latter, sucking up the finished mixture and pressing out the pernicious air in the room where the injection must take place without risking a contamination. The u- tensils must not necessitate any altering of the normal routine. The appliance according to the invention fulfil all these demands and it is characterized by being composed of a rigid, bowl-shaped top section with a cy.lindrical neck closed with a self-sealing -stopper and having means for an airtight securing of a thin-walled bag-like bot¬ tom section, with such a shape that even a small over¬ pressure will inflate it. When the device is applied the ampoule with the medica¬ ment is placed in the bottom section which subsequently is fastened on the top section. The hypodermic needle al¬ ready filled with the solvent is stuck through the stop- per in the neck of the top and that of the ampoule and the solvent is injected into it. The air which by that escapes from the ampoule inflates the bottom part, so that there will not be an over-pressure high enough to press any of the air out through the neck-stopper of the top. Next the appliance is shaken till the medicament is totally dissolved, and now the solution is sucked into the syringe, which then is emptied of air before it is completely drawn out of the neck-stopper. It will be seen that this is the usual routine except from the trifling complication of first putting the am¬ poule into the device, and there are no special demands concerning the designs of the syringe or the ampoule. The top section of the appliance should be. transparent enabling the user to see what he/she is doing, and mea¬ sures should be taken so that the self-sealing stopper is kept so firm that it will not be pulled ou; together with the needle. If it is about one of the very perni¬ cious medicaments, e.g. a cytostaticu , in other words one of those stopping the growth of cells, not only the above safety precautions are demanded during preparation, filling and readying of the medicament, but the very in- jection must be carried out in a room in which only the patient and the person carrying out the injection are present and the operator must wear safety clothes pre¬ venting any contact with or inhalation of the highly dangerous medicament. Apart from the fact that it is far from calming for a patient to be treated by a per¬ son wearing a face mask and other safety outfit, it is time-consuming to take the safety measures mentioned. However, they can be superfluous if the neck of the bowl- shaped top - according to a modification of the invention - is improved with a multi-channel valve giving connec¬ tion between one or more neck-apertures and a central boring in the valve which is provided with a hypodermic needle. The number and the size of the neck-apertures of course must comply with the special medical application of the device. Typically they must be connectable with tubings connecting the device and a "drop" leading into a vein on the patient's arm, with tubings connected with phials with salt water or another liquid and finally with hy¬ podermic syringes. It is obvious that this modification of the invention makes the manufacture more expensive, and therefore it will only be preferred for applications implying very poisonous medicaments where - in return for the complication involved - it solves a medical prob¬ lem which till now has not been solved.satisfactorily, moreover the production price is still neglectable in proportion to the other expenses incurred by the medi- cal treatment. Below the invention will be explained in more details with reference to the drawing of which Fig. 1 Shows an embodiment of the appliance according to the invention. Fig. 2 Shows a cross section of the appliance through the line II-II of fig. 1. Fig. 3 Shows an enlarged cross section of the top of the appliance, and Fig. 4 Shows the inner neck-ring in which the self-sea- ling stopper is fixed. Fig. 5 Shows an enlarged cross section of the modified top part. Fig. 6 Shows a cross section of the top through the line VI-VI of fig. 5. Fig. 7 Shows a valve body. Fig. 8 Shows a cross section of the valve body through the line VIII-VIII of fig. 9. Fig. 9 Shows a cross section through the line x-IX of fig. 7. Fig. lo Shows the top section of the appliance with the valve body in its place. Fig. 11 Is a sketch indicating the use of the embodiment of the invention shown in the figures 5 to 10. As shown in fig. 1 the appliance consists of a hemisphe¬ rical top section 1 made of a transparent plastic with a cylindrical neck 2 above. As shown in fig. 3 the neck has an inside ring-shaped projection 3 which fits into a corresponding groove 4 in the neck-ring 5 shown in fig. 4. The outer diameter of this ring is a little lar¬ ger than the inner diameter of the neck 2, to obtain an elastic pressure between the neck and the ring when the latter is pressed into the former. By an elastic pressure the ring 5 secures a stopper 6 of a self-sea¬ ling material which is placed in an aperture 7 in the top part 1. The projection 3 engaging the groove 4 ef¬ fectively secures that the stopper 6 is not pulled out when a hypodermic need having been stuck through it a- g in is withdrawn. As shown in the figures 1 and 3 the top part 1 has a flange 8 with a strengthening cylindrical rib 9. This flange is intended for the mounting and an air-tight securing of a bag-like thin-walled bottom part 10 made of a material elastic enough to pass the flange 8 with¬ out bursting and to fit tightly around it. As indicated in the figures 1 and 3 the bottom section is provided with a bead/along its upper edge giving it the necessary strenght and elasticity. As mentioned earlier it must be avoided that an over¬ pressure presses air out along an inserted hypodermic needle. The bottom part of the lower section 10 there¬ fore is provided with folds 12 allowing an expansion in case the pressure rises. . Expansion can be obtained in many other ways than by the folding indicated which, however, has the advantage that the bottom section, if made of latex by dipping, easily can be drawn loose from the mould as all its surfaces are parallel to its axes. The number of folds is a secondary thing; the fi- gure shows four, but it is essential that the possible volume expansion is equal to the contents of the ordi¬ nary hypodermic syringe. The indicated embodiment of the top section 1 is easily made by injection moulding. The draft angles enabling the separation of the mould's parts and the removal of the moulded articles are not shown in the drawing as the very manufacturing process of injection moulding is wellknown, and besides it is not part of the inven¬ tion. Principally the neck 2 of the top part may be so short as the strength of the ring, permits, but it should be so long that an inserted hypodermic needle cannot be inadver¬ tently stuck through the thin wall of the bottom section lo, e.g. when the syringe is emptied of air after having been pulled out of the ampoule. This is indicated in fig. 3 where an inserted hypodermic needle has the maximal o- blique position allowed by the given neck-length, viz. by a dotted line. The figures 5 to 10 show a modification of the device which enables the operator to prepare a medicament, to fill and prepare a hypodermic syringe and to inject the medicament into a patient with a certainty that the medi¬ cament gets in touch with no one but the patient. The mo¬ dification consists in the self-sealing stopper 5 not be- ing used and the neck 2 of the hemispherical top section 1 being improved to be a multi-channel valve. As it ap¬ pears from the figures 5 and 6 the neck 2 has an inside cylindrical ring 13 connected with the apertures 14, 15 and 16 by means of the short tubes 17, 18 and 19. As it appears from fig. 6 the angles between the axes of the three short tubes are about 40°. By this and when the valve body 20 is made in a special way you will obtain - as it appears from the following explanation and the fi¬ gures 7, 8 and 9 - that by merely two settings of the valve body the following valve functions are possible: Connection between a bottle with e.g. salt water and a tube leading to the patient, connection between a hypo¬ dermic syringe, an ampule with a perilous medicine be¬ forehand placed within the appliance and connection be- tween the hypodermic syringe and the said tube leading to the patient. The valve body (20) has of a grip 21, a covering disc 22 and a cylindrical part 23. This cylindrical part has an outer diameter which corresponds with the inner diameter of the neck-ring 13 and a circumferential groove stret¬ ching over well over 80 , in other words so far that it just gives a conductive connection between the short tubes 17, 18 and 19 two by two; the cylindrical part also has an axial bore hole 25 ending in a radial bore hole 26 the axis of which is at an angle of 120° to the radius to the middle of the groove 24. Comparing the figures 6 and 8 you will see that the valve body 20 in one position gives a conductive connection between the apertures 15 and 16 and also one between the aperture 14 and the axial bore hole 25 and in another position it will give a con¬ ductive connection between the apertures 14 and 15. Fig. 10 shows a cross section through the hemispherical top section 1 with the valve body 20 in its place in its neck-ring 13. As shown the cylindrical part 23 may be pro¬ vided with a collar 30 preventing that the valve body is torn out unintentionally. A syringe needle is inserted in the axial bore hole 25. As indicated an ordinary am¬ poule with the dissolved medicament is placed in the ap¬ pliance and likewise the front part of a hypodermic sy¬ ringe 29 is pressed into an aperture which - when the valve body 20 is in the position shown - is connected with the axial bore hole and thus with the hypodermic needle 27. Due to the thin wall of the bottom section 10 it is possible to grasp the ampoule and press it up a- gainst the needle 27 so that the latter penetrates the sealing and enters the ampoule. Next the mixing of the medicament with the solvent and the preparation of the syringe can take place as explained above in connection with the figures 1 to 4. Now the valve body 20 is turned to its second position where the aperture in which the syringe 29 has been placed (this will the aperture 14 in fig. 6) now is connected with an aperture in which an injection tube is fixed; he other end of the tube is connected with a "drop" inserted in e.g. a patient's arm- vein; the very injection now can be accomplished without the operator first having to remove the syringe from the appliance and thus without any risk of contaminating the surroundings with the perilous medicament. As shown in fig. 6 and explained earlier the neck 2 has three apertures of which the apertures 15 and 16 are in a conductive connection through the groove 24 in the fi¬ gures 7 and 8, while the aperture 14 is connected with the axial bore hole 25. This means that the injection tube which - as in the example explained here - is con¬ nected with the aperture 15, can be filled with salt wa- ter through the aperture 16 so that the air is driven out of it before the injection, and the latter accomplished and the valve body turned back, the injection tube can be cleaned by a flush-out. This application of the appliance is illustrated in fig. 11 which shows the valve function schematically. Connec- ted up with the.valve's apertures 16, 15 and 14 are res¬ pectively- a hypodermic syringe, an injection tube - the other end of which is connected with a "drop" in a pa¬ tient's arm-vein - and a tube conducting salt water from a bottle. In a first position of the valve body its groove will be at setting 24 thus giving conductive con¬ nection between the apertures 14 and 15 , while its radial bore hole will be at 26 giving conductive connection be¬ tween the inserted syringe and the hypodermic needle in the axial bore hole 25. By this setting the injection tube can be filled with salt water and thus be emptied of air, the medicament be mixed with distilled water, shaken and next absorbed into the syringe. Then the drug-ampoule is drawn free from the hypodermic needle in the axial bore hole and the superflous air is pressed out of the syringe. Now the valve body is turned to another setting, viz. with the groove at 24 ' and the radial bore hole at 26 ' . Now the admissions to the hypodermic needle and the salt water tank are closed, while there is a connection between the injection tube at 15 and the syringe at 16 and conse- quently the dissolved medicament can be injected. If the valve body now is turned back to its first position then the injection tube can be cleaned by flushing. The above example shows one way of designing the neck-valve so that it meets a special demand - and by the way a most urgent one. It will be evident to the expert which altera¬ tions as to number and placing of the outer apertures will be necessary to adapt the invention to other medical pur¬ poses. It should be pointed out that such wellknown details as the placing of stopping high spots or ribs to fix the correct working positions of the valve body are not shown in the figures. It will be ralized that by the invention an appliance is created which affords the same safety as the wellknown "glove-boxes" applied for the manipulation of radioactive substances, but it is much easier to work with as it does not require that medicaments and hypodermic needles are "sluiced" in and out, because it can be brought every¬ where and does not require any cleaning or maintenance as it is simply destroyed after use together with the emptied ampule.

Claims: What is claimed is: 1. An appliance for the preparation of injectable medi¬ caments during which the medicament is found in a con¬ tainer which bars it from the surrounding air and c h a r a c t e r i z e d b y having a rigid top section (1) with a penetrable, self-sealing stopper (6) with means (8,9) for an airtight fastening of a thin-walled bottom section (10) which has such a shape that even a feeble over-pressure will cause an inflation. 2. An appliance as claimed in claim 1 and c h a r a c - t e r i z e d b y the fastening means (8) of the bot¬ tom section (10) being a flange the circumference of which is larger than that of the bottom section (10) and the upper edge of the latter being provided with an elastic bead (11) . 3. An appliance as claimed in claim 1 and c h a r a c ¬ t e r i z e d b y the top section having a cylindrical neck (2) in which a ring (5) is placed pressing against the self-sealing stopper (6) and which has a groove (4) with which a projection (3) on the inside of the neck meshes. 4. An appliance as claimed in claim 3 and c h a r a c ¬ t e r i z e d b y the neck (2) being so long that a hypodermic needle which is stuck through the stopper (5) cannot perforate the bottom section (10) . 5. An appliance as claimed in claim 3 with the modifi¬ cation that the cylindrical neck (2) is constructed as a multi-channel valve with a valve body (20) which part¬ ly gives conductive connection between apertures (14, 15 and 16) in the neck (2) according to the various posi- tions of the valve body, and partly gives conductive connection between one or more of the said apertures and 12 an axial bore hole (25) in the valve body, which is pro¬ vided with a hypodermic needle (27) projecting into the hemispherical top section (1) . 6. An appliance according to claim 5 and c h a r a c - δ t e r i z e d b y an inner cylindrical neck-ring (13) housing a cylindrical valve body (20) and by short tubes (17, 18 and 19) ending at the apertures (14, 15 and 16) in the neck (2) . 7. An appliance according to claim 6 and c h a. r a c - O t e r i z e d b y the valve body (20) having a circum¬ ferential groove (24) along part of its surface and an axial bore hole (25) in which the hypodermic needle (27) is placed and which at its upper end has a radial bore hole (26) so that both the axial bore hole and the groove correspond to the apertures of the short tubes (17, 18 and 19) when the valve body is in its place in the neck-ring (13) . 8. An appliance as claimed in each of the previous claims and c h a r a c t e r i z e d b y its top sec- tion being made of a transparent material. 9. An appliance as claimed in claim 1 and c h a r a c ¬ t e r i z e d b y the bottom section (10) being pro¬ vided with folds (12) parallel to its axis.

Inventors: CHRISTENSEN JOHN FRANKLIN, MAGNUSSEN ERIK, ROERTH MICAEL, CHRISTENSEN, JOHN, FRANKLIN, MAGNUSSEN, ERIK, ROERTH, MICAEL
Applicants: CHRISTENSEN JOHN F, MAGNUSSEN ERIK, ROERTH MICAEL, CHRISTENSEN, JOHN, FRANKLIN, MAGNUSSEN, ERIK, ROERTH, MICAEL
Application year: 1985
Main classification: A61J1
IPC codes: A61J1