Injector module for a syringe and pre-filled syringe provided th

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

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Details

604110, A61M 532

Patent

active

057796831

DESCRIPTION:

BRIEF SUMMARY
The present invention concerns an injector module consisting of a syringe sub-assembly, said module comprising a cylindrical barrel, a needle extending from the proximate extremity of the barrel and a protective sleeve for the needle, which is cylindrical and coaxial with the barrel, said sleeve being slidable between the retracted position, exposing the needle, and the advanced position, concealing the needle.
It also concerns a pre-filled syringe with one or two compartments containing at least one medicinal substance or a component of a medicinal substance to be reconstituted by mixing with another component, said syringe containing on the one hand, an injector module comprising a cylindrical barrel, a needle extending from the proximate extremity of the barrel, and a protective sleeve for the needle, which is cylindrical and coaxial with the barrel, said sleeve being slidable between a retracted position, exposing the needle, and an advanced position, covering the needle; and on the other hand, a propulsion-receptacle module comprising at least one receptacle defining the compartment or compartments holding the medicinal substance or the component of a medicinal substance, and at least one stopper associated with said receptacle, said stopper being slidable within the receptacle so that it acts as a piston, and said receptacle being slidable inside the barrel so that it acts as a piston shaft.
Both the Food and Drug Administration (FDA) and the American Society of Hospital Pharmacists (ASHP), the official United States agencies which control and establish regulations governing medicinal substances and how they are dispensed, recommend using injection systems with a needle which retracts inside the system after use, although this is not a requirement at present. This also the preference of the pharmacological industry and hospitals, particularly medical personnel. A legitimate fear of contracting certain viral illnesses has led doctors and nurses to use extreme precaution to avoid accidental contamination caused by being pricked with a used syringe or the like.
Numerous systems have been devised in an attempt to protect medical practitioners from accidental injuries. Even as early 1931, U.S. Pat. No. 1,921,034 proposed such a system. A syringe inside a receptacle formed of two telescoping elements was used for injections with the user having no contact at all with the needle, even accidentally. As a result, the principle of the retractable needle has been known in the art since at least that time.
U.S. Pat. No. 2,571,653 issued in 1951 describes a syringe with a barrel initially engaged in a sleeve which covers the needle and allows it to be manipulated without danger. At the time of use, the sleeve can be retracted from the needle barrel, making the needle visible and readying the syringe for use.
The disadvantage with all these systems is that the needle is never completely, effectively, and irreversibly protected after use. Current protective measures consist primarily of a sleeve surrounding the hypodermic syringe and the needle during storage, with the needle being extended at the time of use. They offer no provision for the needle retracting after injection of a patient in order to protect medical personnel.
Other embodiments derived from these devices are the subject of U.S. Pat. Nos. 4,738,663, 4,631,057, 4,573,976 and 4,425,120, which describe various guards for hypodermic syringes known in the art.
In particular, the system described in U.S. Pat. No. 5,061,251 attempts to overcome this problem. To accomplish this, the system has a spring associated with a piston shaft; when the spring is compressed, it pushes the needle out of the protective sleeve. In order for the system to work, the friction of the piston inside the syringe barrel must be greater than the restraining force exerted by the spring, or the medicinal substance would be evacuated from the syringe before injection. The piston can only begin to displace and force the injectable substance toward the needle when the spring is blocked

REFERENCES:
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patent: 5061251 (1991-10-01), Jubasz
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patent: 5328485 (1994-07-01), Moreno et al.

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