Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1994-07-19
1996-10-29
Yasko, John D.
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604 87, 604 88, 604201, A61M 3700
Patent
active
055691919
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a device for the preparation of a solution, suspension or emulsion from a medicinally active substance with at least two components of which at least one is in liquid form.
The preparation before usage of a medication from one or several components stored in one hermetically closed assembly and intended to be mixed in this assembly without introducing external elements, poses multiple problems. A large number of bottles for two components have been developed for this purpose. Generally these hordes comprise one single container separated into two compartments by a movable closing member. Both these compartments are hermetically closed during storing. Before use of the medication in question, during the stage of putting the system to use allowance is made for mixing of the substances, of which at least one is in liquid form. For this purpose the movable closing member separating both compartments, is pushed in such a way as to penetrate into an enlarged zone or is provided with a bypass permitting the flow of liquid or solvent toward the other compartment which may either be liquid, solid or sticky, etc.
Manufacturing such double containers is not always easy and does not always fulfil the needs of the pharmaceutical industry for a particular application. A syringe with two components of the type mentioned above, is the subject of U.S. Pat. No. 4,014,330, which describes a syringe with two components respectively contained in two compartments closed by two stoppers or similar pistons. This device is constructed by using two members, which have to be assembled before use. The installation of the bottle, which defines the rear compartment, determines of necessity the use to which the system is put. The preparation and the leading together cannot take place in a closed environment so that important risks of contamination of the product by attending staff and the loss of sterility of the mixture occurs.
Furthermore, the active product is contained in a front container, open at both ends and furnished with screws. This poses problems notably from the time of conditioning a "lyophilisate", powder or liquid.
It is in effect imperative to prepare these active products in a cylindrical bottle with flat heat sealed bottom, to take care of the particular requirements of preparation of these substances by way of known equipment from the time of the empty preparation (washing, siliconizing, fixation with silicon film, "depyrogenization" and sterilization of the bottle), its filling (liquid, powder, "lyophilisate"), its closure (propping) and its conveyance towards an assembly unit with the component allowing for the compartment containing the dilutant.
The system as described in the U.S. Pat. No. 4,014,330 does not fulfil these requirements, for the active product should be prepared in the rear container and the preparation is in such conditions impossible by reason of its construction.
One of the problems posing itself in particular and which cannot so easily be resolved by systems where the components are contained in a single container with two compartments, is that of individual preparation of both components. In other words, the conditions of preparation and sterilization of the one component is not necessarily such as is expedient to the preparation of the other. One solvent cannot be treated in the same way as a lyophilisate or as certain powders. The lyophilisate does not resist the heat required to sterilize a solvent in an autoclave. The lyophilisate is separated from the solvent in a single container by a mobile and resilient stopper. The solvent is in permanent contact with such mobile stopper, so well so, that the partial steam pressure is constantly at its maximum. The risk of steam penetration along such mobile stopper is great and the duration of conservation of the lyophilisate may be compromised or time limited. Consequently the selection of resiliency is limited to that type where the capacity of barrier tightness is the most.
This last constraint imposes the establish
REFERENCES:
patent: 3542023 (1970-11-01), Ogle
patent: 3659602 (1972-05-01), Cloyd
patent: 3841329 (1974-10-01), Killinger
patent: 4014330 (1977-03-01), Genese
patent: 4180070 (1979-12-01), Genese
patent: 4909795 (1990-03-01), Gelabert
patent: 4994029 (1991-02-01), Rohrbough
patent: 5122117 (1992-06-01), Haber et al.
patent: 5171220 (1992-12-01), Morimoto
patent: 5472022 (1995-12-01), Michel et al.
patent: 5472422 (1995-12-01), Ljungquist
Knights Laird J.
Yasko John D.
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