Patent EP-0071288-B1 (EP)
IPC: A61M5/31
Filed: 1982-07-13
Granted: 1985-10-02
Abstract: The invention relates to a disposable syringe comprising a barrel in which a piston is provided and to which a needle is or can be connected to the front, a stopper being present in the barrel between piston and needle or needle connection means. The inner wall of the barrel is locally deformed between stopper and needle or needle connection so that at the area of the deformation injection liquid can reach the cannula past the stopper and during nurse-aspiration the stopper is held, in which body fluid can reach the part of the barrel present behind the stopper. The present invention relates to a disposable hypodermic syringe, and in particular to a syringe comprising a barrel which is open at each end and which for the greater part has an inside diameter which remains the same in the longitudinal direction and is rotationally symmetrical, a piston which can be moved in the barrel and seals same, to which piston a piston rod is or can be connected, a needle or means to connect same to the front of the barrel, a stopper the dimenstions of which are such that it can be provided in a sealing manner and be movable between the piston and the needle or needle connection means, and a finger grip or means to connect same to the outside of the barrel. Such a syringe is known from Netherlands Patent Application No. 7714308 in the name of applicants. When said syringe is used, the injection liquid can pass the stopper through a by-pass recessed in a needle holder. Although the syringe described in this Application has proved to give good satisfaction in practice, it nevertheless has a disadvantage. Prior to administering an injection, it is normally necessary to find out whether the tip of the injection needle is present in the correct place in the patient's body, that is to say whether or not in a blood vessel. Therefore, the piston is usually slightly retracted by means of the piston rod, in which body liquid or no body liquid, respectively, reaches the barrel via the cannula. This process comprises the so-called nurse-aspiration. Because the barrel is manufactured from transparent material, the nurse can see whether the tip of the injection needle is present in a vein, if so desired, and hence whether the injection liquid will be injected directly in the blood circulation system. During said aspiration, the stopper may not be retracted with the piston because as a result of this the by-pass to the barrel might be blocked so that body fluid could not reach the barrel. In this connection it is to be considered that during aspiration the forces which must hold the stopper at the area of the by-pass must be capable of withstanding a considerable pressure on the stopper; in fact, a difference in pressure of approximately 100 kPa can occur on each side of the stopper. In the construction of the syringe known from the above-mentioned Netherlands Patent Application it is not excluded that the stopper during aspiration is slightly retracted, as a result of which the drawing-in of body fluid is prevented. It is the object of the invention to provide a syringe which on the one hand presents the advantages of the syringe known from the above-mentioned Netherlands Patent Application, namely little residual liquid after use, low resistance to the flow of liquid during the injection, and a comparatively thick closure towards the injection needle to avoid diffusion, but which on the other hand does not exhibit the above-mentioned disadvantage. This object can be achieved with a syringe of the kind mentioned in the opening paragraph which, according to the invention, is characterized in that the inner wall of the barrel between the stopper and the needle or the needle connection means is locally deformed over a length which is slightly larger than the length of the stopper in such manner that the distance between diametrically oppositely located inner wall parts at the area of the deformation varies between a slightly smaller diameter and an at least equally large diameter as the inside diameter of the remaining part of the barrel, so that both upon administering an injection, injection liquid present in the barrel can reach the cannula past the stopper, and during nurse-aspiration the stopper is held at the area of the deformation, in which body fluid can reach the part of the barrel present behind the stopper past the stopper. Thus the syringe according to the invention offers the certainty that the nurse-aspiration will not be impeded or prevented. This certainty can also be reached with an injection syringe having a needle holder, provided shape and dimensions of the needle holder are such that the stopper during aspiration is held in the needle holder. Therefore, the invention also relates to a syringe comprising a barrel which is open at each end and has a rotationally symmetrical inside diameter which remains the same in the longitudinal direction; a piston which is movable in the barrel and seals same and to which a piston rod is or can be connected; a stopper the dimensions of which are such that is can be provided in a sealing manner in the opening in the front end of the barrel; a finger grip or means to connect same to the outside of the barrel; a needle holder, consisting of a collar provided or to be provided in a sealing manner to the front end of the barrel; a neck in which an injection needle is or can be connected; and a hollow shaft between collar and neck, in which a passage is formed in the inner wall of the shaft and the rear face of the neck, through which passage injection liquid present in the barrel can reach the cannula when the stopper during use of the syringe is moved into the shaft of the needle holder. This syringe is characterized in that the inner wall of the shaft of the needle holder has such a cross-section that the distance between diametrically oppositely located parts of the inner wall of the shaft varies between a slightly smaller diameter and an at least equally large diameter as the inside diameter of the barrel, so that during nurse-aspiration the stopper is held in the shaft and body fluid can reach the barrel past the stopper. The first-mentioned syringe in which the by-pass for the injection liquid is provided in the wall of the barrel is to be preferred. As a matter of fact, the use of a separate needle holder as in the last-mentioned syringe has the disadvantage that during assembly an extra operation has to be carried out so that the cost-price of the syringe is increased. Moreover, any extra component for a syringe, for example a needle holder, increases the cost-price, of course. On the other hand, the use of a separate needle holder also has a few advantages. As will be explained hereinafter, in a syringe having a needle holder there is the possibility to supply the syringe in a bipartite construction. Another advantage relates to the relatively small tolerance which is permitted in the dimensions of the inner wall of the barrel at the area of the deformation or the inner wall of the shaft of the needle holder, respectively. A plastic component to be manufactured by injection moulding in a mould, for example a needle holder, can be manufactured with very great accuracy; when a barrel wall, generally made of glass, is locally deformed, less accuracy in the dimensions of the deformation will usually be reached. -A syringe having a by-pass in the glass barrel wall is known from literature. U.S Pat. No. 2,717,601 relates to a barrel for a two-compartment syringe, said barrel comprising a liquid compartment closed by means of a piston and a stopper. By exerting pressure on the piston, the stopper is moved in the direction of a second compartment which comprises a medicament in the solid state. The stopper passes a by-pass which may be formed by grooves recessed in the inner wall or in that the wall is locally compressed to an oval shape. The liquid can reach the second compartment through the by-pass formed so as to be able to dissolve the solid medicament location. After shaking the barrel to dissolve the medicament in the liquid, the resulting injection liquid can be injected in the usual manner. U.S Pat. No. 3,330,282 relates to a combination of a syringe and a mixing vial; this combination may also be considered to be a two-compartment syringe. The syringe described in said patent also comprises a by-pass in the form of a groove recessed in the inner wall past which the liquid can pass the stopper so as to be able to reach the solid medicament in the mixing vial in this manner. In order to prevent the stopper from blocking the entrance to the cannula at the area of the by-pass, the stopper has two projections which keep the stopper at some distance from said entrance. A two-compartment syringe is also described in the British Patent Specification No. 871,854. This known injection syringe has two compartments separated by a stopper, the forward compartment comprising a solid medicament, the rearward one comprising the solvent for this medicament. The solid medicament is sealingly closed up between said stopper and a sealing member, the solvent between said stopper and a piston. By retracting the piston and the stopper, rigidly connected with the piston by a piston rod, the pressure in the medicament compartment is reduced, as a result of which the solvent flows in this compartment. A by-pass in the stopper enables the solvent to pass the stopper, this by-pass is formed by wedge-shaped projections on the inner wall of the syringe ampoule. The by-pass construction in the syringe according to the present invention is meant for a pre-filled single-compartment syringe and not for a multi-compartment syringe. Therefore, other requirements are imposed upon the shape and construction of the syringe according to the invention than upon those of the above-mentioned known syringes. The necessity of being able, during nurse-aspiration, to