1. Technical Field
The disclosure relates generally to an applicator system for applying a tissue sealant based on human or animal proteins and more particularly to an apparatus for applying an adhesive formed by combining solutions of the proteins to tissues or organs for sealing wounds or leaks, stopping bleeding and the like.
2. Description of Related Art
A fibrin sealant is a biological adhesive sealant formed by mixing two protein components, including fibrinogen and thrombin. Each protein component is derived from human plasma and is subjected to virus elimination and/or inactivation procedures. The components are typically individually dehydrated and stored in separate vials as sterile freeze-dried powders.
It is known that purified fibrinogen and thrombin, together with a variety of known adjuvants, can be combined in vitro to produce a hemostatic agent and/or a tissue sealant. Because of the rapid interaction of fibrinogen and thrombin, it is important to maintain these two blood proteins separate until applied at the application site. These protein solutions are generally delivered by devices such as a dual syringe apparatus.
One dual syringe apparatus for applying a fibrinogen-based tissue adhesive is disclosed in U.S. Pat. No. 4,359,049 to Redl et al. Redl et al. disclose a mechanism in which two standardized one-way syringes are held in a support having a common actuating means. The dispensing end of each syringe is inserted into a collection manifold where the two components are mixed. The components are then dispensed through a common needle onto the application site.
A dual syringe apparatus for the application of fibrinogen and thrombin solutions to an application site generally contain several parts, such as a syringe plunger, a xe2x80x9cYxe2x80x9d manifold connector, a dispensing needle, a syringe holder, syringe needles, and conduits for transporting the solutions to the dispensing needle. Therefore, known fibrin sealant applicators, such as disclosed in U.S. Pat. No. 4,359,049 to Redl et al. discussed above, and in U.S. Pat. No. 4,874,368 to Miller et al. and U.S. Pat. No. 4,979,942 to Wolf et al. are difficult to reuse. The replenishment of the protein components typically require a combination of steps including, inter alia, removing a clip which couples the syringe plunger, removing the syringe plunger, detaching the syringes from the xe2x80x9cYxe2x80x9d connector, removing the syringes from the holder, inserting new syringes, affixing the syringes to the xe2x80x9cYxe2x80x9d connector, adding fibrinogen to one syringe and thrombin to another syringe, replacing the syringe plunger, replacing the plunger clip, and dispensing the solutions. In an application where time is of the essence, such a lengthy replenishing process is impractical and cumbersome.
Therefore, it would be advantageous to provide a fibrin sealant applicator system which obviates the need to replenish the solutions after the solutions have been depleted; provides for a quick and error-proof method of usage; keeps the solutions within air-sealed compartments prior to usage to prevent air from mixing with the solutions; and is economical.
Fibrin sealant applicator systems are provided for dispensing a first and a second protein solution to form a biological adhesive which overcome the disadvantages of the prior art. The first and second protein solutions are preferably fibrinogen and thrombin solutions which may intermix on an application site or within the applicator to form a fibrin sealant. The fibrin sealant applicator systems according to the present disclosure include two piston-type sub-assemblies coupled to two vials storing the fibrinogen and thrombin via a coupling unit. The piston-type sub-assemblies store sterilized water within reservoirs which are in fluid communication with the vials via the coupling unit. The water is forced into the vials to form the fibrinogen and thrombin solutions. The solutions are then drawn into the reservoirs and a Y-coupler is attached to the distal end of the piston-type sub-assemblies. The Y-coupler provides fluid communication between the reservoirs and a nozzle body for dispensing the solutions when distal pressure is created within the reservoirs to force the solutions towards the nozzle body.
USPTO Backgrounds
USPTO Backgrounds