Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1984-12-31
1986-06-24
Yasko, John D.
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
A61M 500
Patent
active
045965617
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The present application concerns a prefilled single-dose syringe featuring a barrel open at at least one of its ends and provided with a narrowed-diameter portion neighboring this end; a stoppering device fitted into the barrel to stopper said narrowed-diameter portion, which stoppering device is movable axially between a first position, called the storage position, and a second position, called the injection position, and featuring an internal tube; and a nozzle attached to this stoppering device, fitted onto the shank of the open end of the barrel and provided with a ferrule equipped with an axial channel, which axial channel is intended to communicate with the internal tube of the movable stoppering device when it is moved into its second position.
There already exist a large number of prefilled syringes that are made up of a body or barrel containing the medicine to be injected into the patient, a movable plunger inside of this barrel, a needle attached to one of the ends of the barrel, and a cap that protects the barrel and ensures its airtightness. Such an existing device is illustrated, for example, by Swiss Pat. No. 571 858. It is currently still used a great deal because it does not require decanting and because the single dose is guaranteed by the manufacturer.
However, even if the syringe should, in principle, be thrown away, it remains reusable, and there is nothing to guarantee, if not for a tamper-proof original packaging, that the syringe contains a proper medicine. The fact that the airtightness is ensured by the cap, which contains air, constitutes another disadvantage of this device. Furthermore, the ampul requires costly testing after filling and after the plunger is put in place.
To overcome these various drawbacks was proposed a syringe of the ampul-syringe type, described in European Patent Application No. 83112127.2 filed by the applicant, regarding a barrel containing a medicine under pressure, the opening of which is stoppered by a stoppering device that forms a unit with a nozzle, equipped with an attachment ferrule, an injection needle, and a tube capable of putting the interior of the body of the syringe in communuication with the needle; both the nozzle and the stoppering device attached to it are movable between a stoppered position and an in-use position.
This principle of stoppering by means of a nozzle could have been adapted for a syringe of a different type, comprising a body and a plunger to slide axially inside the body, as well as for a double-compartment syringe or mixing syringe that consists of two plungers serving two chambers containing, initially, two different respective products intended to be mixed before they are injected. This latter device, for example, is described in the applicant's European Patent Application No. 83113098.4.
The manual or automatic testing mentioned earlier of ampuls containing medicines to be injected, with the intention of detecting the possible presence of solid particles in the medicine contained in the ampul, proves to be relatively costly for the manufacturer. This testing is responsible for a not negligible precentage of the production costs of the product, due to the fact that it requires a testing station, the installation and operating costs of which are high.
In addition, the losses due to unacceptable finished products have a negative influence on the cost price of sales of acceptable products.
Although this testing, performed by the manufacturer at great expense, theoretically permits the arrival at a product that is considered acceptable---that is, of which at least 90% or 95% is greater than 50 micrometers--free of any solid particles, the practical reality is quite different because storage, on the one hand, and the manipulations required before using the product, on the other, may alter its quality considerably. In effect, during storage certain products may produce solid deposits, which are not entirely dissolved after shaking prior to injection. In the mixing syringes, the powder of freeze-
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patent: 4061143 (1977-12-01), Ishikawa
patent: 4365626 (1982-12-01), House
"Glass Embolism", published in The Lancet, Dec. 16, 1972.
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"Particulate Contamination in Intravenous Fluids: Nature, Origin, and Hazard", published in Pharmaceutical Journal, Mar. 3, 1973.
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Howald Ernst
Meyer Gabriel
Meditec S.A.
Yasko John D.
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