JP2000515770A - Applicator for fibrin sealant - Google Patents

Abstract

SUMMARY OF THE INVENTION The present invention provides a novel two or more component application system and method for fibrin sealants using gas. The apparatus and method of the present invention have concentrically arranged annular openings (14, 16) for each component located concentric with and radially outward of the central gas discharge opening (12) at the outlet end of the spray head (10). It is characterized by the following. Each reservoir of each component, such as a syringe cartridge or cylinder, is in liquid communication with the spray head and is preferably adapted to be operated by common means.

Description

DETAILED DESCRIPTION OF THE INVENTION Applicators for Fibrin Sealants Background Art Redl U.S. Pat. S. Patent No. 4359049 discloses a dual barrel syringe which is useful for applying a tissue adhesive such as fibrin glue or fibrin sealant to a human or animal in need thereof. The described fibrin sealant mainly comprises two main components, a fibrinogen-containing component and a thrombin-containing component, each used in liquid form. Basically, when thrombin and fibrinogen mix, the fibrinogen peptide is cleaved and the resulting fibrin polymerizes, resulting in a state that forms a clot useful for sealing fluids and air leaks for hemostasis and tissue bonding. To avoid premature clot formation, a double-barreled applicator is used, which, of course, keeps the two components isolated until application to the patient is required. U. S. Patent No. According to the disclosure of 4359049, the pistons in the two cartridges, each containing one component, operate in common so that liquid can be dispensed from each at the same time. Typically, a barrel or cartridge is connected to the head and in fluid communication with two flow paths in the head (one for each component), the two flow paths being connected to a common flow path exiting at the applicator head. Send. Other prior art patents describe various mixing loads that mix the two or more components used in these and other surgical sealants. For example, U.S.A. acquired by Hemaldics. S. Patent No. No. 5,116,315 describes a head in which a liquid conduit leading from a component cartridge enters a mixing chamber, which imparts a swirling motion of each component before each component exits a common outlet flow path. It has become. Proper incorporation of each component is desirable to be able to form a uniform fibrin sealant. Inefficient mixing results in coadministration of fibrinogen and thrombin, which in fact only produces small yields of sealant. The complication of the fibrin sealant applicator is the premature clot formation in the equipment, especially the equipment that mixes the components in the mixing head and / or the devices where the components exit through a common flow path. Can be After the initial spray of sealant, the clot blocks the outlet flow path, rendering the applicator useless and greatly reducing the flexibility of the surgeon to remove the surgical sealant. Immuno, U.S.A. S. Patent No. No. 4631055 describes a gas transport channel for blowing gas into a needle or a mixing head while each component is being discharged. However, constant and uniform distribution of material to the anatomical region of interest has not yet been achieved. In fact, a considerable amount of components is wasted. E. Edwardson et al. P. Patent No. 592242 discloses the first fully autologous fibrin sealant. It provides for co-administration of a fibrin monomer solution and a buffer solution that contributes to the polymerization of the fibrin monomer, thereby conferring clot formation. Fibrin monomer can be produced from a single blood source, preferably the blood source of the patient receiving the sealant, in less than 30 minutes. This breakthrough technique delivers a fixed volume of fibrin monomer solution from a blood sample of about 140-160 ml. In order to benefit from this safe, efficient, self-contained sealant product, uniform and efficient incorporation is even more important, and therefore a new application of the two or more components that make up the surgical sealant. Apparatus and methods are useful in addition to the techniques described above. SUMMARY OF THE INVENTION In accordance with the present invention, a novel apparatus and method for applying the components of a fibrin sealant is described. The apparatus comprises a gas source and a reservoir for each component, wherein the gas source and each component reservoir can be operated by common means. Each reservoir and gas source is separately in liquid communication with a spray head having a central opening or its outlet end and an annular opening concentric with and radially outward from the central opening, whereby the gas and each The components are discharged through separate openings. Preferably, the gas is vented from the central opening and the components of the fibrin sealant are vented separately from each annular opening. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an end view of the outlet end of the spray head. FIG. 2 is a cross-sectional view of the spray head. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS This example provides for a very efficient incorporation of the fibrin sealant components outside the spray head of the applicator, thereby resulting in a lean use of each component and of the applicator. Eliminate the problem of clogging. The device incorporates a new spray head having a central opening and two or more concentric annular openings for each component of the fibrin sealant located radially outside the central opening. The spray head can be used with predetermined gas and component sources that are conveniently arranged. Typically, it is advantageous to load each component into a syringe cartridge and arrange the cartridges containing the predetermined components in parallel. The cartridges arranged in this manner are preferably held in common and can be actuated by common means, for example a trigger or plunger, to actuate the pistons in each cartridge in common. The gas source may be in line with a remote source or additional cartridge or reservoir therein, or may be attached to the applicator as needed. The gas is typically operated with component operation, but other than this joint operation, any independent gas operation would be advantageous. Separate flow paths provide liquid communication from each component and gas source to the spray head. The fibrin sealant component is conventionally known. Suitable fibrinogen- and thrombin-containing components are described in US Pat. S. Patent No. No. 5116315, the same No. 4359049; No. 4874368, and the same No. No. 473561 6, ibid. 4631055 and the like. E. FIG. P. Patent No. Preference is given to using the fibrin sealant component of 592242, i.e. a solution which gives a fibrin monomer containing solution and the polymerization of the monomers, preferably crosslinking to the fibrin clot. This is, for example, a buffer solution that raises the pH of the fibrin monomer solution. The use of a pH 10 buffer (acetate) containing a calcium ion source is preferred. Any gas may be used, for example, argon, CO ₂ , air, nitrogen and the like. The outlet face of the spray head of the present invention is generally indicated at 10 in FIG. Although the use of a central opening 12 for venting gas is preferred, it may alternatively be used for one of the components of the fibrin sealant. The first annular opening 14 is located concentrically with the center opening 12 and outside the radius thereof. Preferably, one of the components is drained from the first annular opening 14, most preferably the pH buffer component is drained. The illustrated second annular opening 16 is located concentrically with the other two openings and radially outside thereof. This second annular opening 16 is preferably used for discharging the solution containing the fibrin monomer. The appropriate dimensions of each opening may be any convenient dimensions for those skilled in the art and depend on each component. The central aperture preferably has a diameter of about 0.15 to 0.35 mm, most preferably 0.30 mm. Preferably, the inner diameter of the first annular opening is about 0. 75 to 0.85 mm, the outer diameter of the first annular opening is about 1.0 to 1.25 mm. Preferably, the inner diameter of the second annular opening is about 1.35 to 1.55 mm and the outer diameter is about 1.80 to 2.0 mm. It should be noted that any other components and suitable business can be used in the method and apparatus of the present invention without departing from the scope of the present invention.

Claims (1)

[Claims]   Apply a fibrin sealant consisting of 1.2 components, and apply the same An application device comprising an operable storage tank and a gas source, wherein the components and And gas are each in liquid communication with the spray head via separate flow paths; The head is located in the center of the outlet end of the spray and has a central opening for exhausting gas. The spray is at the outlet end of the spray head, concentric with and above the central opening A first annular opening for discharging one of the fibrin sealant components, and a spray At the outlet end of the head, the first annular opening is concentric with the central opening and the first annular opening. Discharges the second component of the fibrin sealant component that has a larger radius than the mouth A fibrin sealant application device having a second annular opening .   2. Applicator for fibrin sealant with two components of fibrin sealant From the spray head at the outlet end A gas vehicle passing through the center hole located at A first component comprising a fibrin sealant through a first annular opening; And a fib through a second annular opening concentric with and radially outward from the first annular opening By simultaneously discharging the second component of the phosphorus sealant, uniform fibrous It is characterized by providing uniform and efficient application of each component forming the sealant Method of applying fibrin sealant.   3. The fibrin monomer-containing solution is discharged from the second annular opening, and the fibrin mono is discharged. Providing Polymerization and Crosslinking of Mer to Form Fibrin II Crosslinked Polymer Sealant 3. The coating according to claim 2, wherein a buffer solution suitable for draining is discharged from the first annular opening. Method.