Fluent material handling – with receiver or receiver coacting mea – Processes – Filling dispensers
Reexamination Certificate
2000-09-27
2002-03-19
Douglas, Steven O. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Processes
Filling dispensers
C141S018000, C141S098000, C141S329000, C141S027000, C604S415000
Reexamination Certificate
active
06357489
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to a device for storing a liquid medicinal substance, particularly a substance forming a component of a multi-component tissue adhesive. The invention further relates to a method for filling an applicator for a medicinal multi-component substance, particularly for a multi-component tissue adhesive, with the individual components of the medicinal substance and the tissue adhesive, respectively, by use of the above mentioned device.
Known from EP-B-0 037 393, EP-B-0 210 160, U.S. Pat. No. 4,874,368, U.S. Pat. No. 4,978,336, DE-A-42 23 356, EP-B-0 315 222, WO-A-96/19940 and WO-A-95/31137 are applicators and respectively application devices provided for two-component tissue adhesives and comprising two substantially syringe-body-shaped supply containers attached to the connecting ends of a dispenser device which in turn comprises a dispensing end for dispensing the individual components. The preparation of such an applicator for use e.g. in an operating theater is relatively bothersome and requires a certain routinized skill. For instance, each component of the tissue adhesive has to be introduced in the individual supply containers. The individual components are usually delivered in ampoule-shaped glass vessels having their openings closed by a closure body (septum or the like). By means of a puncture needle mounted to the distal end of the supply container, the closure body is perforated for subsequent suction of its the contents into the supply container. Then, the supply container has to be separated from the puncture needle and connected to the dispenser device. Thus, the preparation of the applicator necessitates a large number of individual steps which are made still more aggravating since the person holding the applicator during filling will have to work under sterile conditions whereas the vessels for the individual components are usually not sterile and thus should not be held by this person. For this reason, these vessels are held by a second person who will position the vessels in such a manner that the person holding the applicator can pierce the puncture needles into the closures bodies for filling the supply containers. In this regard, the risk of injuries to the person holding the vessel should not be underestimated.
The state of the art further includes three-way valves comprising three connectors provided with a switching element for switching the fluid connection. In this case, the switching element is arranged for movement between a first position wherein the first connector is in fluid connection with the second connector and the third connector is shut, and a second position wherein the first connector is in fluid connection with the third connector while the second connector is shut. A three-way valve designed especially for the use of receiving vessels for medicinal substances and having its opening provided with a pierceable closure body is known from WO-A-96/29113.
It has already been proposed to connect the three-way valve known from WO-A-96/29113 between the supply containers and the dispenser device of an applicator for multi-component adhesives. On the one hand, the resultant applicator arrangement is filled in a considerably easier manner because the mechanical connection between the dispenser device and the supply containers is not cut off during the filling process; thus, already before the filling and up to the switching of the three-way valves, the connector will be in the same condition which it will assume also for applying the tissue adhesive. Still, however, the filling process performed by the above proposed applicator with three-way valve is problematic due to the risk that the person holding the applicator and thus working under sterile conditions might come into contact with the outer surface of the vessel which is not germ-free, i.e. is non-sterile.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a device suited to store liquid medicinal substances in such a manner that said substances, in spite of a non-sterile condition of the outer surface of the vessel accommodating the substance, can be handled by a person working under sterile conditions.
To achieve the above object, the invention proposes a device for storing a liquid medicinal substance, particularly a component of a multi-component tissue adhesive, comprising
a vessel for the medicinal substance, said vessel having a bottom wall, a side wall and an opening opposite the bottom wall and closed by a closure body which in turn is pierceable from outside by a puncture needle placed into sealed abutment, and
a receiver cup for said vessel, said receiver cup having a bottom wall and a side wall formed with an edge delimiting the side wall at its upper end opposite the bottom wall.
The device according to the invention serves for taking up a vessel provided to accommodate a liquid medicinal substance and formed with an opening closed by a closure body pierceable by a puncture needle. According to the invention, a vessel of the above type, whose external surface is not germ-free and which—since its contents would react sensitively to treatment processes for sterilizing its outer surface—should not be sterilized after filling, can be accommodated in a receiver cup which in turn can be sterilized by the known method. The combination of vessel and receiver cup resulting from the above arrangement can now be handled also by a person working under sterile conditions.
The inventive measure of inserting a vessel with a non-sterile outer surface into a sterilized receiver cup, is suited to facilitate—under the aspect of the safeguarding of a germ-free working process —especially the filling of an applicator for a medicinal multi-component substance and particularly for a multi-component tissue adhesive if the applicator comprises three-way valves adapted to have the vessels coupled thereto and arranged between the supply containers and the dispenser device of the applicator. By means of the inventive device, the filling process will now be performed in that the person working under sterile conditions holds the receiver cup while keeping the opening thereof unobstructed so that another person can introduce the vessel containing the medicinal substance, with the bottom wall thereof facing towards the bottom wall of the receiver cup, into the receiver cup. All of the subsequent processing steps during the filling of the applicator are then carried out by the person working under sterile conditions, with an extremely low danger of this person coming into contact with non-sterilized surfaces of the vessel. Notably, by the same person who also holds the applicator, the vessel arranged in the receiver cup held by that very person can also be mounted onto the coupling adapter of the three-way valve so that, thereafter, the medicinal substance can be sucked from the vessel into the respective supply container by displacing the pistons of the supply containers. By moving the fluid switching element of the three-way valve, the applicator can now be directly used for application, if desired, after removal of the receiver cup holding the vessel therein.
For the handling of the applicator during filling, it is of advantage if the three-way valves comprise the features described in WO-A-96/29113. Thus, particularly, it may be suitably provided that the fluid connection of the three-way valve can be changed by a simple rotating movement of the fluid switch element. Further, it may be suitably provided that the coupling adapter designed to receive the opening region of the vessel is supported for rotation and is connected to the fluid switch element for rotating the latter along with the rotation of the adapter. Further, it is useful for the handling of the applicator during application if the applicator, after the fluid switch element has been moved into its position for establishing a fluid connection between the supply container and the dispenser device of the applicator, can be easily detached.
For the handling of the receiver cup togeth
Douglas Steven O.
Omrix Biopharmaceuticals S.A.
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