US 2642868 A
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.w m m mm w m wfl M 2 w M 5 o. H. PONTIUS SURGICAL AMPOULE-SYRINGE Filed May 19 1949 June 23, 1953 Patented June 23, 19 53 SURGICAL AlllPOULE-SYRINGE Oswald H. Pontius, Frankfurt'am Main Hochst, Germany, assignor to Farbwerke Hoechst A. G. vormals Meister Lucius und Briining, Frankfurt am Main Hochst, Germany, a company of Germany Application May-19, 1949, Serial No. 94,060 In Germany February 24, 1949 I 1 Claim. 1
The present invention relates to a surgica ampoule-syringe. I
Numerous attempts have alreadybeen made to overcome the difliculties known in the sterile parenteral administration of a drug by means of a syringe. In the main, two processes have attained practical importance. The one replaces the usual sealed ampoule by a cylindrical glass container closed at both ends by a rubber stopper or the like (of. German Patents Nos. 464,770, 638,496, 664,001). By placing it in a special holder, this container serves at the same time as a syringe body, so that the refilling of the liquid into another container can be dispensed with. Parts of the syringe casing, the cannula and the stopper to be pierced have, however, to be sterilised separately.
According to the other process, sterilisation by the physician is not necessary. A cannulap-rotected by a glass tube is attached to the ampoule, and the liquid is expelled therefrom by compressed gas contained in the ampoule or by gas pressure produced by a chemical reaction just prior to the injection. A valve-like device, of which many modifications are known, separates the liquid to be injected from the cannula during storage and must be opened for the injection by manipulations which are sometimes inconvenient (of. German Patents .Nos. 456,867, 558,854, 645,764, 733,993).
The latter process solves the problem perfectly as regards sterility, but has the drawback that the ampoule must be held in a vertical position throughout the injection, so that thecompressed gas is enabled to drive out the liquid. This position is not always convenient, for instance when injecting into the mouth; furthermore there is always the risk that, towards the end of the opertion, by carelessness or lackof ability, gas may be injected simultaneously.
Attempts have also been made to construct an ampoule with a cannula in position in such a manner that it serves at the same time as a syringe with a movable piston, for instance according to German Patent No. 639,855. The devices hitherto produced, however, are so complicated in manufacture and handling that they are unsuitable for practical use, both owing to their manufacturing cost and also on account of other serious drawbacks which they involve. is not possible in practice to fill the above mentioned device of German Patent No. 639,855 with the injection liquid under sterile conditions, and subsequent sterilisation is out of the question on account of the paramn wax seals. For the solu- Thus, it
2 I I tion of the problem of sterile injection, not only is the question of application of importance, but the method of manufacture of the ampoules must guarantee absolute sterility of. the contents and of those. parts coming into contact therewith during the injection.
I have found that by means of an ampoulesyringe in accordance with the present invention the drawbacks of former devices are overcome.
An ampoule-syringe according to this invention has a cannula in position, or a tip to which a cannula can be attached, and a sealing stopper intended to serve as a piston, and the liquid container serves asthe body of the syringe, more especially when held in a suitable holder.
Between the cannula and. the actual liquid container a means must be provided for preventing contact between the liquidand the cannula.
Such means may comprise a short capillary tube which the liquid is prevented from entering by gas pressure. Alternatively it may consist of a non-return valve.
In one form 0f ampoule-syringe according to the invention, at one end of a cylindrical ampoule and separated from the liquid container proper by a novel automatic valve, there is mounted an injection needle; the other end of the ampoule is closed by a novel bored stopper protective gas. Compared with the similar combinations hitherto known witha fitted cannula the ampoule according to the present invention neither constitutes a complete syring nor contains compressed gas, but requires an accessory device for driving in the stopper, of which devices the practitionerrequires only one. This method essentially simplifies the construction and the manufacture of the ampoules and renders them more economic compared with the ampoule-syringes hitherto known. Furthermore, the physician has the absolute guarantee that he can make his injections under sterile condi-,- tions and, moreover, in any desired position and direction. 1 j a a Very many injection liquids may not come into contact with iron during storage for fear of being discoloured or decomposed. But apart from this fact, difiiculties would arise if the in-.
jectionliquid were allowed to enter the protective tube of the cannula. Therefore, the cannula must-be separated from the liquid by a barrier which-prevents their coming into contact during,
3 storage and transport and, at the same time, oflers no obstruction to the injection. The present invention complies with the requirement in a novel and very simple way by the means set forth above.
Two forms of ampoule-syringe are illustrated by way of example in the accompanying drawings in which Figure l is a longitudinal section of one form of ampoule, Figures 2 and 3 are longitudinal sections of the injection end of another form of ampoule showing two positions of the valve member, and Figures 4-6 are diagrammatic drawings showing stages in the filling operation.
In the drawings I is the liquid container, 2 the movable stopper which on the one hand closes the container and, on the other-hand.- serves as the injection piston; 3 is a small glass rod which closes the hole bored through the stopper, 4 is a short capillary tube with walls strong enough to resist the stress during injection, 5 is a small hollow space wherein ends the cannula 6. The latter may be fused into. the glass or may be mounted, for instance, in a stopper I4 so that it does not move; I is a narrow glass tube which has been sealed off at the top by fusing. and which protects the cannula. The liquid container I may'lbe. filled up to the capillary tube 4, while in the hollow space 5 and connected therewith by the cannula in the protecting tube I a suitable gas pressure may exist. With such an arrangement it is impossible for the liquid to percolate into the hollow space 5 through the capillary tube which is only a few tenths of a millimeter wide; even if the ampoules are stored upside down, the surface tension together with the gas pressure prevent such an occurrence. Moreover gas cannot bubble backinto the liquid. In the actual injection, however, the capillary tube, which has the same internal diameter as the cannula, offers no obstruction. With the removal of protecting tube 1 the excess gas pressure disappears and the capillary. tube now behaves as a. prolongation of the cannula.
' when larger quantities of liquid are required to be injected by means of wider cannulae, the capillary tube is advantageously replaced by a non-retum valve which consists of a short constriction ofthe container and a correspondingly sized spherical ball or, in order to avoid. the. socalled trilling, an'eg'g-shaped body, in the hollow space 5. Fig. 2 shows such a valve in the closed position: B isthe egg-shaped body which may be of rubber. When filling the ampoule, the valve must remain open until the end of'the operation. For this purpose a wire 9 (Fig. 3) is introduced through the cannula into the-hollow space so that it prevents the valve body 8 from falling down. When the ampoule is filled, the wire is removed, for which operation the protective tube must be taken off for a shorttime. The ampoule is then operated in the same way as one provided with a capillary tube.
In contrast to the known rubber pistonstoppers, the stopper. 2 is bored." The bore serves for filling purposes and is afterwards closed by means of a small rod, forinstance of glass. The stopper is provided in known manner with annular grooves for a lubricating liquid, for instance glycerol. It may berounded at the top in conformity with the shoulders of the ampoule so that as much as possible of the injection solution is utilized. After the stopper has been put in place, the inside of the ampoule. must be cleansed. In order to prevent portions of the washing liquid from remaining between theglass 4 wall and the rounded part of the stopper, it is advantageous to provide the rounded part of the stopper with a transverse slot wide enough to allow the remaining liquid to run off. In Fig. 1, II] shows this slot in cross-section.
The ampoules are filledunder reduced pressure according to the process usually applied. The cleaned ampoules, provided with cannulae and protective tubes may, for instance, be held in batches in a perforated plate by clamps, as shown schematically in Fig. 4. II is the perforated plate, I2 are the clamps which hold the ampoules I so that they cannot fall even when filled. The ampoules are held during the whole filling procedure in vertical position, the cannulae in upward direction. The plate is suspended in a filling vessel which, at the bottom, is provided with another plate I3 with cylindrical recesses located just below the boreholes of the stoppers. Into the recesses the small rods 3 which eifect the closure are inserted, so that they project vertically by about two thirds of their length; see Fig. 4. The upper plate I I is at first only lowered towards the other plate to such an extent that between the glass rods and the stoppers a space remains which is sufiicient for the introduction of the liquids and gases. Thereupon, washing liquid and injection solution are consecutively introduced into the vessel and, in known manner, by application of a vacuum, filled into the amponies or emptied therefrom. By regulating the vacuum and the pressure, it is easily possible to fill the ampoules only to such an extent that the liquid does not reach the capillary tube. This must remain dry during the whole filling procedure, since otherwise small quantities of the liquid might enter the hollow space 5. As soon as the final filling has taken place, the upper plate is lowered to the plate underneath until the glass rods have penetrated into the borings of the piston-stoppers as shown in Fig. 5. Centering devices I5, and suitably shaped centering rings (not shown) around the borings of the piston-stoppers provide for a smooth penetration of the rods. Then, upper plate II with the filed and provisionally closed ampoules is taken out of the vessel and placed on a second plate I6 (Fig. 6) which instead of the recesses is provided with corresponding shaped projections II. The latter fulfil two purposes; first, to push in the glass rods flush with thestoppers and, second, to hold the piston-stoppers in place during the following sterilisation. If the ampoules were all of exactly the same length-which in practice is scarcely possible-a fiat plate would suffice. By'the projections small difierences are compensated. (If, on pushing in the glass rods, any of the stoppers, all of which have to be sufficiently free to effect their final purpose, have been shifted, these will be urged back into their correct position by the pressure exerted inside the ampoules during sterilisation and the glass rods will be properly driven in.) As the last step of the filling-operation, the gas is removed from the liquid container proper. Each pistonstopper isdriven-into the upright ampoule until the liquid just reaches the capillary tube (in the case of ampoules with non-return valves, after releasing thevalve ball or body). By suitably selecting the dimensions of the protective tube and the hollow space 5, on the'one hand, and the leve1 of the-liquid during filling on the other hand, it is possible to obtain any desired gas pressure.- In order (in the case of ampoules with capillary tubesL-to prevent the piston-stopper from being pushed back it may be pushed in by means of a suitable cork which is left in the ampoule, thus providing a perfect closure. A groove in, or a hole boredthrough the cork prevents the formation of a vacuum between the cork and the piston-stopper when the former is removed before using the ampoule.
Some injection liquids require the application of a protective gas. Such gas may be used without any difficulty with the ampoules of the present invention. washed prior to filling and the air has been removed completely by evacuation, the protective gas may be allowed to stream in. A gas which is free from oxygen renders possible the use of cannulae made of ordinary steel which is desirable for reasons of economy. These cannulae are then not liable to corrosion even in the moist atmosphere which prevails in contact therewith during storage.
It is obvious that in place of the cannula a tip may be employed suitable for subsequent attachment of the ordinary cannulae, which tip likewise has to be protected by a covering. The cylindrical part of the ampoule may be calibrated for several injections (on one and the same patient). The ampoules can be adapted to all requirements of the physician. To use them for injections, only three operations are required: removal of the protective cover, removal of the cork and placing in the injecting holder; after removal of the gas as with any syringe, the injection may be made and absolute sterility is guaranteed.
With some ability it is also possible to make the injections directly with the ampoule without the holder, with the aid only of a small rod.
When the ampoule has been I claim:
A surgical ampoule-syringe comprising a liquid-filled cylindrical containersealed at one end by a piston stopper and constricted at the other end to form a projecting stem, a cannula mounted in said stem, a gas-tight cover connected to said stem over the outer end of the cannula, an enlarged space formed in the stem adjacent the mounted cannula end, a narrow passageway formed in the stem and leading from the container to said enlarged space, said enlarged space being in communication with the inner' end of the cannula and adapted to contain an entrapped gas therein, said passageway being of such dimensions as to operate as acapillary conduit and with the aid of the said entrapped gas within the.
gas-tight cover, cannula and enlarged space to function as a valve and prevent entrance of the liquid from the container into the enlarged space through said passageway until the gas-tight seal 1 formed by the said cover is broken.
References Cited in the file of this patent UNITED STATES PATENTS Germany June 16, 1932