US3368557A - Ampoule with actuatable cover automatically readying ampoule for injection - Google Patents

Description

. 3,368,55 7 LLY Feb. 13, 1968 V. HASSING ET Al- AMPOULE wma AOTUATABLE COVER AuTOMATlOA READYINO AMPOULE FOR INJECTION Filed May 24, 1965 United States Patent O M 3,368,557 AMPOULE WITH ACTUATABLE COVER AU- TOMATICALLY READYING AMPOULE FOR INJECTION Vagn Hassing, Farum, and Ejnar Kristian Jeppesen,

Bagsvaerd, Denmark, assignors to Novo Terapeutisk Laboratorium A/S, Copenhagen, Denmark, a Danish joint-stock company Filed May 24, 1965, Ser. No. 458,009 Claims priority, application Denmark, May 28, 1964, 2,674/ 64 5 Claims. (Cl. 12S-221) ABSTRACT 0F THE DISCLOSURE An injection ampoule with a two-part cover which is actuatable axially on the ampoule for automatically ejecting an outer part of the cover exposing the injection needle and placing it in communication with the ampoule contents thereby readying the ampoule for injection `by a single movement of the cover.

The present invention relates to an injection ampoule, closed at one end with a fixed piercable closure and provided with a tubular neck, on which a cannula provided with a socket is axially displaceably arranged, and into which a perforation tube projects. The tube is disposed in communication with the cannula, the end of the perforation tube adjacent the pierceable closure is point-ed.

Such known injection ampoules are sold with contents, for example a sterile remedy or medicament, are normally discarded after use. The cannula or needle is normally, by means of its socket, arranged on the tubular neck immediately before the ampoule is to be used. As the cannula socket is pushed into the tubular neck, it will actuate the projecting end of the perforation tube so that its opposite pointed end projects through a pierceable closure. whereby the hollow injection cannula is placed in communication with the interior of the ampoule. The sterile medicament may now, during an injection, be forced out through the cannula, either by compression of the arnpoule, if the latter consists of a compressible material, or if the ampoule has the form of a rigid cylinder, by expelling the remedy of the ampoule by means of a piston.

However, injection ampoules are known, in which the perforation tube forms a part of the cannula. The cannula has the form of a special double cannula, which between its pointed ends is provided with an outside annular bead. In this known injection ampoule the cannula is surrounded by a protective cap made in one piece and provided with a threaded skirt screwed on one end of the ampoule. The part of the protective cap surrounding the cannula is connected with the threaded skirt over a weakened, annular wall portion, and on the threaded skirt are provided external threads. A threaded sleeve is screwed having a ange directed axially inwardly towards the weakened wall portion. When this type of known ampoule is to be used, the sleeve is screwed inwardly in a direction towards the ampoule. The axial ilange of the threaded sleeve will abut against the protective cap adjacent the weakened wall portion of the latter. If one continues to screw the threaded sleeve inwardly, the protective cap will be broken along the weakened wall portion, whereby the outer part of the cap falls off so that the cannula will be uncovered. If the threaded sleeve is screwed further inwardly, the axial flange on the threaded sleeve will press the bead on the double cannula inwardly .towards the ampoule, and the inner end of the cannula will penetrate into the interior of the ampoule, and finally the cannula will be fixed by the clamping of the bead of the can- 3,368,557 Patented Feb. 13, 1958 nula between the axial ange of the threaded sleeve and the adjacent end of the ampoule. The injection ampoule is then ready for use.

The structure last described has, in comparison with the rst-mentioned structure, the advantage that it is not necessary to touch the sterile cannula, as the ampoule may be made ready for use by turning the threaded sleeve. Thus there is no risk that the cannula is contaminated when the injection ampoule is made ready for use. However, the last-mentioned of the known injection ampoules has the disadvantage that it is rather expensive because it requires the use of a special cannula. Furthermore, the necessary screwing of the threaded sleeve for making the ampoule ready for use is rather time-consuming.

yThe object of the invention is to provide an injection ampoule having not only all the advantages of the known injection ampoules, but also having such a construction that it can be made ready for use by a single axial displacement movement.

This may, according to the invention, be obtained by having the cannula and its socket surrounded by a twopiece protective cap slidable in relation to the ampoule. The outer part of the protective cap, surrounding the cannula, has inner parts which, by axial displacement of the protective cap, may be brought to abut against the cannula socket. The two cap parts are secured to each other by locking means adapted to be released by an axial force on the two cap parts in a direction away from each other. The injection ampoule according to the invention is very simply made read for use fby a displacement of the inner part of the protective cap in a direction towards the ampoule. During this movement the outer part of the pro tective cap will abut against the cannula socket, whereby the socket will be moved in a direction towards the ampoule. By this movement of the cannula socket the pointed end of the perforation tube will pass through a pierceable closure and into the interior of the ampoule. The movement of the cannula socket will finally lbe stopped by the cannula socket abutting against the ampoule or against the parts secured to the ampoule. When the cannula socket cannot be moved further inwardly, a continued application of force on the inner cap part in direction towards the ampoule will result in the outer cap part being actuated by such a great axial force in a direction away from the inner cap part that the connection between the two cap parts is released. The outer cap part will then fall oit and uncover the cannula placing the injection ampoule in readiness for use. The functional steps described in detail above follow in practice very quickly after each other, and the ampoule can, as mentioned, be made ready for use in a moment by an inward displacement of the inner cap part. With the injection arnpoule according to the invention it is furthermore possible, contrary to what is the case with known ampoules, to use a cheap standard cannula, if desired, which may be used again after sterilization, e.g. in connection with a common syringe.

If the threaded sleeve in known injection ampoules were replaced by an axially displaceable sleeve, no injection ampoule would be obtained which in practice comes up to the ampoule according to the invention. When casting the protective cap for the known structures it is necessary to work with such wide tolerances that the thickness of the weakened wall portion will vary substantially. In several cases the wall portion will be so thick that it would be very diicult to break it -by a manual axial displacement of the sleeve provided with the axial ilange. In several other cases the weakened wall portion will be so thin that it breaks unintentionally or may even have holes, which is. of course, unfortunate since the cannula in this case will become unsterile.

It is important that the cannula during an injection is maintained firmly secured to the tubular neck, and that the perforation tube is actually passed through the piercable closure. So the inner cap part may, according to the invention, be provided with an inside shoulder, which by inward displacement of the cap part may be brought to abut against a corresponding, outside shoulder on the cannula socket. `If the locking means is of such a type that it is released by a pressure, less than that necessary to pass the perforation tube -through the piercable closure, the inner shoulder of the inner cap part will be pressed towards the outside shoulder of the cannula socket, after the locking means has been released, so that the pressure necessary for the perforation and the securing of the cannula socket will be transferred to the cannula socket. Furthermore during the injection the cannula socket may be held pressed firmly against the :ampoule or parts secured thereto.

As previously mentioned the ampoule as such may be formed of a compressible material. However, it is preferred to give it the form of a rigid cylinder, the mouth of which is surrounded by a cylindrical part having a tubular neck. In the last-mentioned case the inner cap part may, according to the invention, have a strapped, cylindrical form, and the end of the inner cap part facing the ampoule may have such an inner diameter that it may surround and be guided axially on the ampoule, whereas the adjacent part of the cap part may have such an inner diameter that it is guided on, abuts against the cylindrical part of the tubular neck. This provides good axial control of the protective cap in removing it and simultaneously a good seal between the cylindrical part of the neck and the adjacent part of the protective cap, thereby preventing contamination of the sterile cannula surrounded by the protective cap during storage of the injection ampoule. The seal may easily be obtained between the protective cap and the tubular neck, because the neck is normally manufactured of metal and may thus be manufactured with rather narrow tolerances. On the other hand, it will be more diicult to obtain tightness or a seal between the protective cap and the ampoule as such, since the ampoule is normally made of glass resulting in rather wide tolerances.

In certain cases it is not desired to use a protective cap, the inner part of which covers part of the ampoule, since part of a label secured thereto may thus be covered. According to the invention the tubular neck may have a substantially cylindrical surface, while the inner cap part may have inner, radially directed guiding ribs, the inner edges of which abut against the outer surface of the neck, and the end of the inner cap part facing the ampoule may have such an inner diameter that it is guided on and tightly surrounds the mouth of the ampoule. The tight fit of the cap part around the mouth of the ampoule ensures that the sterile cannula is not contaminated before use, and the guiding ribs ensure a sufficiently good guiding of the inner cap part during axial displacement of the latter in preparing the ampoule for use.

The locking means between the two cap parts may in principle be of any type, provided it is released by a suitable axial force between the parts. However, according to the invention the locking means may advantageously have the form of a snap fastening connection. Such a connection may -be made by forming the ends of the cap parts adjacent to each other in a simple way.

The snap fastening connection may, according to the invention, consist of an annular bead arranged on the end of the outer cap part, projecting axially from a radially extending flange and fitting by a light interference fit into the adjacent end opening of the inner cap part. Thus the desired holding together of the cap parts is obtained, and at the same time the radial flange abutting against the adjacent end of the inner part of the protective cap results in stability of the connection against sidewards forces acting on the outer cap part. Accordingly an unintentional uncovering of the cannula is prevented.

The snap fastening connection may, according to the invention, instead be formed by an outwardly pointed neck formed on the outer end of the inner cap part and having a conical outer surface provided with an annular groove, and by a socket formed on the inner end of the outer cap part, and having a conical inner surface which may be brought to surround and abut against the outer surface of the neck. The socket has an inwardly projecting bead fitting into the annular groove. In this embodiment a particularly good stability against incidental outside actuations of the outer cap part is obtained because of the conical abutting surface between the two parts of the protective cap.

If the conicity of the conical surfaces is comparatively small, one may risk that when the bead of the outer cap part has been pressed out of the corresponding groove in the neck of the inner cap part, it will abut resiliently against the conical outer surface of the neck outside the groove, and consequently the outer cap part will tend to hang on to the inner cap part, after the snap fastener has been released. This may, according to the invention, be prevented by providing another 4annular groove between the outer end of the neck and the annular groove and immediately adjacent the last-mentioned groove.

In the following description the invention will be further explained with reference to the drawings, in which FIG. 1 is a fragmentary longitudinal section view of an embodiment of the injection ampoule according to the invention,

FIG. 2 is afragmentary section view, on an enlarged scale, of the locking means between the parts of the protective cap,

FIG. 3 is a fragmentary longitudinal section View of another embodiment of the locking means, and

FIG. 4 is a longitudinal section view of another embodiment of the injection ampoule according to the invention,

In FIG. 1 of the drawings there is shown 1an ampoule 10 of glass, rigid plastic or a similar material. The ampoule has a neck 11 provided with a collar or flange 12, on which a punctuable or piercable disc 13 of e.g. rubber or soft plastic is arranged. The disc 13 is held firmly on the collar 12 by means of a tubular neck 14, a lower edge 15 of which is bent inwardly under the collar 12, while .an inner shoulder 16 bears against the piercable disc 13. The outer free end of the neck 14 has a slightly conical outer surface.

Within the neck 14 there is -arranged a perforation tube 17 pointed at its inner end facing the disc 13, while the other end of said perforation tube projects beyond the neck 14. A cannula socket 18 provided with a cannula 19 rests on the perforation tube 17. The cannula socket 18 has an inner conical surface 20 corresponding to the conical surface of the neck 14 and surrounding the upper end of the neck.

The cannula 19, the cannula socket 18, the neck 14, and the upper end of the ampoule 10 are surrounded by a two-piece tubular protective cap or cover 21, an outer part 22 of which is secured to an inner part 23 by means of a snap fastening connection or releasable friction connections 24. The snap fastening connection consists, as more clearly -appears from FIG. 2, as an annular bead 25 arranged on the end of the outer end 22 of the protective cap. The beads project in an axial direction from a radially extending flange 26 and lits by a light interference fit, into an adjacent end opening 27 of Athe inner cap part 23. The end opening 27 has a configuration corresponding to the bead 25.

The inner cap part 23 is provided with steps 28 and 29 so that the space between the protective cap 21 and the parts which the cap surrounds is as small as possible. Furthermore, the cap part 23 is provided with a circumferential grip flange 30. A part 31 of the cap part 23 lying between the steps 29 and the grip flange 30 has an inner diameter exactly corresponding to the outer diameter of a cylindrical part 32 of the tubular neck I14 surrounding the neck or flange 12 of the ampoule 10. The protective cap is guided, on the tubular neck part 32 and also contamination of the sterilized cannula 19 is prevented as later explained. The protective cap is further guided in relation to the ampoule by means of a cylindrical part 33 guidingly surrounding part of the cylindrical ampoule 10.

The injection ampoule is provided with a piston, not shown, arranged within the ampoule 10, said piston being connected with a piston rod projecting from the ampoule. The ampoule 10 contains some remedy or iluid to be administered to a patient by injection.

The injection ampoule comes from the factory in the state shown in FIG. 1. When an injection is to be made, the protective cap 21 is, by means of the gripange 30, displaced axially in a direction towards the ampoule 10. Since the outer end of the cannula socket 18 bears against the bead 25 on the cap part 22, the cannula socket and the cannula will take part in the axial movement of the protective cap. It is the same with the perforation tube 17, the outer end of which bears against the cannula socket 18. So the irst thing that happens during the axial displacement of the protective cap 21 is that the pointed end of the perforation tube 17 is pressed through the piercable disc 13. During the continued axial movement of the protective cap toward the ampoule the conical surface of the cap will be wedged on the outer conical surface of the neck 14. The cannula socket 18 can then no longer be moved, and a continued inward actuation of the inner cap part 23 will therefore result in breaking of the snap fastening connection 24 between the two cap parts 22 and 23 so that the bead 25, by means of the cannula socket 18, is pushed out of the end opening 27. The outer cap part 22 now falls off the cannula 19 so that said cannula is uncovered, and the injection ampoule is then ready for use.

Any releasable locking means between the two cap parts 22 and 23 may be used if only these locking means can be released by exposing the outer cap part to a suitable outward press-ure by the cannula socket. The pressure necessary to release the locking means should preferably be greater than that necessary to perforate the disc 13 by means of the perforation tube 17 and to press the cannula socket 18 sumciently onto the neck 14, so that the cannula is only uncovered when the injection ampoule is quite ready for use, i.e., when the disc 13 has been perforated, and the cannula socket 18 has been pressed on the neck 14. However, it is also po-ssible to use locking means more easily releasable, so that the cannula 19 is at once uncovered when the displacement of the protective cap is, started. By continuing the displacement of the cap an inner shoulder 34- formed by the step 28 will bear against an annular shoulder 35 on the cannula socket 18, whereby the socket is moved inwardly towards the ampoule, so that the perforation of the disc 13 and the securing of the cannula socket on the neck 14 will take place in the indicated order.

In FIG- 3 another snap fastening connection 36j is shown, which may be used in connection with the embodiment of the injection ampoule according to the invention, shown in FIG. 1, instead of the snap fastening connection 24. The snap fastening connection 36 consists of a truncated cone-formed neck 38 formed on the inner cap part 23 and of a socket 39 tting therewith and formed on the lower end of the outer cap part 22. The socket has an inner truncated cone-formed surface which may be brought to surround and abut against the outer surface of the neck 3-8. The outer surface of the neck 38 is provided with two annular grooves 40` and 41 adjacent each other, and the socket 39' has an inner bead 42 at its inner end, said bead engaging the groove 41, when the cap parts 22 and 23 are secured t-o each other by means of the snap fastening connection 36. In this position the free end of the neck 38 furthermore abuts against an inner shoulder 43 in the socket 39. Thus comparatively large abutting surfaces between the inner and the outer cap part are provided when the parts are secured to each other by means of the snap fastening connection 36, so that there is no risk that the snap fastening connction is unintentionally released by a small outer actuation of the outer cap part 22.

The snap fastening connection, shown in FIG. 3, may as previously described in connection with the snap fastening connection 24, be released by displacing the inner cap part 23 inwa-rdly towards the ampoule 10, the cannula socket 18 then at some time prevents further inward movement of the outer cap part 22. The bead 42 is then forced out of the groove 41, and the presenceof the groove 40 prevents the cap part 22 from hanging on to the outer conical surface of the neck 38.

The injection ampoule shown in FIG. 4 has a double cannula 44 having a substantially cylindrical cannula socket 45. An inner pointed end 46 of the double cannula 44 serves as a perforation tube, and the cannula socket 45 is arranged axially displaceably within the neck 14 of the ampoule 10. The neck is substantially cylindrical. The injection ampoule shown in FIG. 4 is provided with a protective cap 47 consisting of an outer and an inner part 48 and 49, respectively, which are kept together by means of a snap fastening connection substantially corresponding to that shown in FIG. 3 apart from the outer groove 40 being somewhat more attened in FIG. 4 than in FIG. 3. Inner, radial ribs 50 are formed inside the outer cap part 48. Lower edges of the ribs abut the outer end surface of the cannula socket 45. The inner cap part 49 has at its outer end an inwardly directed edge 51, and the cannula socket 4S is provided with a corresponding outwardly extending flange 52. Also the inner cap part 49 is provided wit-h inner, radial ribs 53, the inner edges of which touch the outer surface of the neck 14, which here is cylindrical, and the ribs 53 thus serve to axially guide the cap part. The cap part 49 is furthermore axially guided by its inner part having an inner diameter corresponding to the outer diameter of the cylindrical part 32 surrounding the collar 12 of the ampoule 10.

When the injection ampoule shown in FIG. 4 is to be used, the corrugated outer side of the inner cap part 49 is clasped, and the cap part is moved axially inwardly. When only the snap fastening connection between the two parts of the protective cap 47 is sufficiently strong, the outer cap part 48 will also be brought axially inwards. As the ribs 50 in the cap part 48 abut the cannula socket 45, the socket will also be moved axially inwardly and the inner end of thedou-ble cannula 44 will be passed through the piercable disc 13 and into the interior of the ampoule 10. When the inward movement of the cannula socket 45 is stopped, either as a result of the abutment of the ange 52 on the cannula socket against the outer edge of the neck 14, or of the abutment of the inner end of the cannula socket against the closing disc 13, a further axially inward movement of the inner cap part 49 will cause the release of the snap fastening connection between the two cap parts so that the outer cap part 48 falls off, whereby the outer part of the cannula 44 is uncovered. The injection ampoule is now made ready for use. If the snap fastening connection between the cap parts for some reason should be released too early, so that the outer cap part 48 falls olf before the cannula end 46 has perforated the closing disc 13, the inwardly directed edge 51 of the inner cap part 49 will abut against the flange 52 on the cannula socket 45 so that the injection ampoule may nevertheless be made ready for use by a continued inward movement of the inner cap part 49.

The injection ampoule according to the invention may as explained above be made ready for use by a single action, and the risk of contamination of the sterile cannula before an injection is prevented. After use the injection ampoule will normally be disposed of, since the ampoule may be made so inexpensively that a succeeding sterilization will be unprofitable. However, it should be noted that with some embodiments of the injection ampoule according to the invention it is possible to use standard cannulae and, therefore, the standard cannulae may, if desired, be sterilized and used again, e.g. in connection with a common syringe.

What we claim is:

1. An injection ampoule comprising, a container portion for a medicament, means defining an outlet opening on said ampoule container portion, a puncturable sealing member covering said outlet, an extension neck member on said container portion having a bore in communication with said puncturable sealing member, a two-part tubular cap on said ampoule actuatable axially relative to said ampoule container portion in a direction toward said container portion, a cannula in said cap mounted within said cap and movable axially therewith, a socket mounting said cannula in said cap movable axially with said cap and cooperative with said neck member mounting said cannula on said neck member extending in said neck member bore in communication with the interior of said container portion when said cap is actuated axially toward said container portion, means on said cannula puncturing said sealing member when said cap is actuated and constructed to provide communication between an injection end of the cannula and the interior of said container portion, said cap comprising an outer end portion having a closed end and releasable frictionally axially from a remainder of said cap for exposing said cannula from an injection, means on said outer end portion of said cap defining a releasable friction connection with said remainder of said cap, means on said socket limiting the axial travel thereof relative to said extension neck member and allowing sufficient axial travel for said sealing member to be punctured and said cannula placed in communication with the interior of said container portion, and means on said cap effective to release said outer end portion of said cap from the remainder of said cap when said cap is actuated axially on said ampoule toward said container portion and the travel of said socket ceases, whereby when said cap is manually actuated axially toward said container portion said sealing member is automatically punctured and said cannula is placed in communication with the interior of said container portion and the outer end portion of said cap is ejected axially exposing the cannula in position and readiness for an injection.

2. An injection ampoule according to claim 1, in which said extension neck member has a tapered outer configuration, said means on said socket limiting axial travel thereof relative to said extension neck member comprising means defining a tapered bore in said socket into which said extension neck member is received and said socket wedged and stopping axial travel of said outer portion of said cap and said cannula when said cap is actuated, said socket having an outer end engaged by said means on said cap rendered effective to release the outer end portion of said cap when said cap is actuated axially.

3. An injection ampoule according to claim 1, in which remainder of said cap comprises a tubular portion guided axially on said container portion.

4. An injection ampoule according to claim 1, in which said socket is disposed in said bore of said extension neck member, said means on said cannula puncturing said sealing member comprises an inner end portion of said cannula, said means on said socket limiting axial travel thereof relative to said extension neck member comprises a radial projection axially spaced from said extension neck member and engaging the outer end of said extension neck member when said cap is actuated toward said container portion.

5. An injection ampoule comprising, a container portion for a medicament, means defining an outlet opening on said container portion, a puncturable sealing member covering said outlet, an extension neck member on said container portion having a bore in communication with said sealing member, a two-piece protective cap on said ampoule frictionally mounted for axial travel on said ampoule container portion in a direction toward said container portion, a cannula mounted internally of said tubular cap spaced axially from said sealing member, means releasably connecting the cannula to the cap for limited axial travel therewith when said cap is actuated toward said container portion, said cap comprising an outer end portion having a closed end and an inner portion releasably connected together, means on said cannula for travel through said bore puncturing said sealing member and placing an injection end of said cannula in communication with the interior of said container portion, said means releasably connecting said cannula to said cap comprising socket means for said cannula cooperating with said cap to limit axial travel to said cannula when said cap is actuated toward said container portion and allowing sufficient axial travel relative to said neck member to allow puncturing of said sealing member and said cannula to be placed in communication with the interior of said container portion, and said socket means having means cooperative with said extension neck member rendered effective to cause release of the outer end of said cap from the inner portion thereof and eject said outer end axially to clear said cannula so that said cannula is exposed and in readiness for an injection when axial travel of said socket means ceases.

References Cited RICHARD A. GAUDET, Prima/'y Examiner.

D. L. BAKER, Assistant Examiner.

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