Tilting direct dual filling device

#Use of tissue sealants and other biological materials is an important emerging surgical technique, well adapted for the operating room or field environments such as the doctor's office or mobile medical units. Preferred sealants include fibrin sealants which are formed from blood plasma components and comprise, on the one hand, a first component containing fibrinogen and Factor XIII and, on the other hand, a second component which usually includes thrombin and calcium ions. Until May of 1998, when the FDA first approved such products, fibrin sealants were not commercially available in the US, therefore use of fibrin sealant was limited to supplies produced within the clinic, which are not subject to FDA control. Following FDA approval, the use of fibrin sealants has been increasing steadily. During use, the fibrinogen is capable of polymerizing and being cross-linked to form a solid fibrin clot when the components are mixed. The necessary additional factors to stimulate relevant portions of the natural blood coagulation cascade are suitably distributed between the fibrinogen and thrombin components.

#Antanavich et al., U.S. Pat. No. 5,585,007, whose disclosure and references are hereby incorporated herein by reference in their entirety, provides an extensive discussion of the literature relating to fibrinogen sealant preparation (column 1, line 20 to column 4, line 62) and applicators (column 4 line 62 to column 5, line 14), as well as a bibliography, (columns 6-10) and is a helpful guide to the teachings of prior workers in the field.

#Depending upon the potency of the particular formulations employed, coagulation of the sealant may take place very rapidly, yielding a gel within perhaps 10 or 20 seconds. Though often very desirable for surgical reasons, such fast-acting properties present potential problems of fouling or clogging during the application process. These problems must be overcome in devising suitable applicators, methods of application, and devices suitable for filling the applicators.

#The apparatus of the present invention will be explained in more detail by way of the accompanying drawings, wherein:

#FIG. 1 shows a perspective view of the direct dual filing device of the present invention.

#FIG. 2 shows a perspective view of the direct dual filing device of the present invention wherein the hood is displaced from the container support device.

#Disclosed herein is a detailed description of various illustrated embodiments of the invention. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the invention. The section titles and overall organization of the present detailed description are for the purpose of convenience only and are not intended to limit the present invention.

#The tilting direct dual filling device of the present invention is used in conjunction with a multiple component applicator to dispense a multiple component fluid to a work surface. Those skilled in the art will appreciate that the present invention is particularly well suited to dispense a multiple component tissue sealant capable of effecting hemostasis or achieving other therapeutic results.

#The tilting direct dual filling device of the present invention is designed to permit the withdrawal by an applicator of a fluid from at least one commercially available fluid container. Those skilled in the art will appreciate that the present invention is adapted to functionally couple to a variety of applicators, including, for example, syringe-type applicators such as the DUPLOJECT™ syringe-type applicator manufactured by the Baxter Corporation. The present invention permits the controlled withdrawal of fluid from the fluid container and filling of at least one material reservoir contained in or in communication with the applicator. Furthermore, the tilting direct dual filling device of the present invention may permit the use and transport of commercially available component containers within a sterile environment. It is anticipated as being within the scope of the present invention to produce a tilting direct dual filling device capable of functionally coupling with a variety of applicators in a variety of sizes.