AMPOULE-SYRINGE

Abstract: The invention describes an ampoule-syringe comprising a single, substantially cylindrical body (1), divided by a central narrow neck portion (2) in two compartments, constituting the ampoule (14) and the syringe (15) respectively, said narrow neck portion forming the housing for the needle (5). In order to detach the syringe from the ampoule it is sufficient to break the cylindrical shell in corres­ spondence of said narrow neck portion.

Description: The present invention relates to an ampoule-syringe consisting substantially of a cylindrical body, preferably made of glass, divided in two compartments by a narrow neck portion. One compartment, closed at one end, constitutes the ampoule filled with liquid, whilst the other compartment is the real syringe in which a piston is inserted, and which is sealed at the open end by a movable cap, capable of keeping an inner sterile ambient. The ampoule-syringe according to the invention is characterized by a special arrangement of its parts, which makes the use thereof extremely handy and easy if compared to other known devices. Both for pratical and sanitary reasons, it is often advisable to put up the injection products in the form of ampoule-syringe, namely directly inserting the product in the container that will form the syringe body, to the end ― besides of simplifying the various operations ― of avoiding handlings that could lead to mistakes in the medicine dosage, or to hygiene deficiencies and the like. In the thus made ampoule-syringes the piston rod that ejects the product cannot enter the syringe completely but protrudes from same to a certain extent; this causes difficulties, also due to the need of securing the rod in this position during packaging and transport. Furthermore, other problems are caused by the necessity of providing suitable needle protecting means, to be removed before use. WO-A-8000306 describes an ampoule-syringe comprising a syringe body, a needle (12) rigidly fixed to the syringe body through a needle holder and a tank surrounding the needle and fixed to the syringe body by a sealing fixing element. The present invention provides an ampoule-syringe that is less bulky and cheaper than the known devices, in accordance with the characterizing part of claim 1. At the side where the piston is inserted, the syringe is closed by a cap that provides hermetical sealing and sterile conditions. In this way both the needle and the piston rod are sheltered by the same shell of which the ampoule-syringe consists, the latter thus resulting much handier to use and of less cumbersome size; further, many problems can be solved, connected with the packaging and/or handling of products. The present invention will be now described in detail, with special reference to the attached drawings, in which: Fig. 1 shows the single disassembled components of the ampoule-syringe according to the invention; Fig. 2 shows an ampoule-syringe according to the invention, assembled and ready to be filled with the pharmaceutical solution. The ampoule-syringe according to the invention is made up of a cylindrical element 1 (see Fig. 1), made of glass or other suitable matter, opportunely shaped so as to have a first narrow neck portion 2 in the middle (see Fig. 2) and a second narrow neck portion 3 at one V-shaped end 9. At the side opposite the narrow neck 3, cylinder 1 is shaped into an annular edge or rim 4. The portion comprised between the narrow neck portions 2 and 3 is intended to form ampoule 14, whilst the portion comprised between the narrow neck portion 2 and rim 4 is intended to form syringe 15. The ampoule-syringe is then completed by a needle 5 and a piston 7 provided with a rod 8. Needle 5 is secured to a support 6 that would either snap-fit ― e.g. by to a support 6 that would either snap-fit ― e.g. by resilient deformation of the matter which it consists of ― or stand firmly blocked in position during the making of the narrow neck portion 2. In the embodiment shown by Figs. 1 and 2, the support 6 of needle 5 consists of a substantially spherical body provided with a truncated cone-like projecting element, to the purpose of preventing said support from being pushed out of its seat by the pressure of the liquid being injected. To the free end of rod 8 there is applied a substantially flat, round finger-rest element 10, allowing to first suck up the liquid from the ampoule-syringe, and then to exert a pressure on the piston during injection. The diameter of element 10 is slightly greater than the outer diameter of annular edge 4. In between the finger-rest 10 and the rim 4 of the syringe an annular gasket 11 is inserted; the syringe is closed by a cap 12. A sheath 13 provided with holes, made of flexible material, is arranged around the cylindrical body, in correspondence of the narrow neck portion 2 that separates the ampoule from the real syringe. As it will appear more clearly hereinafter, the perforated sheath 13 is so designed as to avoid any possible fall of the ampoule after the user has broken up the ampoule-syringe, to make the suction of the ampoule content in the syringe easier and to prevent the user from hurting himself with some fragments of glass. The preparation and assembly of the components of the ampoule-syringe according to the invention are carried out by first shaping cylinder 1 so as to form therein narrow neck portions 2 and 3, and to form the V-shaped portion 9 and rim 4. The needle 5 is positioned by elastically inserting support 6 in the narrow neck portion 2. Alternatively, support 6 is clamped in position during the forming of the narrow neck portion 2. At this stage piston 7 is inserted in the syringe, which is then hermetically sealed by cap 12, after that gasket 11 has been placed between finger-rest 10 and rim 4. After covering the central part with the perforated sheath 13, the ampoule-syringe is ready to be filled with the pharmaceutical solution. After filling, the V-shaped portion 9 is given the shape of the mouthpiece of a flute, closing thus ampoule 14 (this feature is not illustrated in the Figure). The ampoule-syringe is now ready for use. To this end, it is sufficient to remove cap 12, break up the ampoule-syringe at the narrow neck portion 2 in order to detach the syringe from the ampoule and to suck up the liquid contained therein. The advantages provided by the invention will appear from the above description. More specifically, it should be noted that all the ampoule-syringe components are perfectly protected during transport, as they are held inside the glass shell, while gasket 11 and cap 12 provide a perfect sealing, and therefore a sterile ambient. Of course the sizes, as well as the employed materials, can vary in function of the various requirements of use.

Claims: 1. Ampoule-syringe of the kind comprising a main body (1) which is divided in two compartments by a narrow neck (2) central portion, to which a needle (5) and its needle holder (6) are fixedly attached, the first of said compartments forming a syringe (15) provided with a plunger (7) and the second compartment forming an ampoule (14) for sealingly containing, during storage, a liquid product to be injected and for protectively enclosing the needle during storage and during the filling operation of the syringe, characterized in that: ― the main body is formed as a single, integral piece; and is breakable at a narrow neck (2) in order to detach the ampoule from the syringe, to allow the air to enter the ampoule while the syringe sucks the liquid product, and to free the needle. 2. Ampoule -syringe according to claim 1, characterized by providing, in correspondence of the central zone, an outer sheath (13) of deformable material, intended as a protection for the user, when he separates the ampoule (14) from the syringe (15) by breaking up the glass main body (1). 3. Ampoule syringe according to claim 1, characterized by providing an annular gasket (11) set between the syringe edge and the finger-rest (10) secured to the piston rod (8), there being provided a cap (12) for keeping the whole firmly in position and hermetically sealed.

Inventors: MATTONI, GUGLIELMO
Applicants: SIGMA-TAU INDUSTRIE FARMACEUTICHE RIUNITE S.P.A.
Application year: 1988
Main classification: A61J1
IPC codes: A61J1, A61M5