BACKGROUND 1. Technical Field The present disclosure relates generally to biological and/or synthetic fluid applicators and, more particularly, to dispenser manifolds and related applicators for mixing and dispensing components of biologically compatible tissue adhesives, synthetic sealants and/or hemostats.

2. Description of Related Art Biologically derived as well as synthetic sealants, hemostats and/or adhesives are used to treat wounds in instances where external dressings or sutures are not totally effective.

A common treatment takes advantage of the rapid reaction which occurs when a solution of clotting factors, such as fibrinogen, comes into contact with a solution of a catalyst, such as thrombin, to form a complex which acts as a tissue adhesive. This rapid reaction typically commences within 2 seconds after the solutions initially contact one another, and it typically attains a soft set within 10 seconds of contact. A common name for such a complex is fibrin glue.

Prior fibrin glue delivery systems may generally be categorized as utilizing either turbulence within a solution or overlapping contact of airborne sprays to obtain mixing. The apparatus utilized by either of these systems typically includes confining a fibrinogen solution separately from a thrombin solution, then permitting these two solutions to mix either immediately prior to or upon application on a

wound. Typically, these solutions are confined within separate syringes prior to mixing.

An example of a delivery system based on internal mixing of two solutions is provided in U. S. Pat. Nos. 4,978,336 and 5,116,315, both to Capozzi et al., the content of which are incorporated herein by reference. In view of this characteristic of these adhesive solutions, mixing and dispensing has conventionally been done as close as possible to the distal end of the applicator to minimize clogging.

In addition, replaceable tips configured to both mix and dispense the adhesive have been proposed. See, e. g. the Capozzi et al. patents referenced above. This device provides an easily manipulated dual syringe apparatus which enables the two solutions to mix and dispense over a wound.

SUMMARY The present disclosure provides a manifold assembly including a disposable integral mixing and dispensing chamber, disposed in direct contact with the component reservoirs as a replaceable element. In a preferred embodiment, the disposable mixing and dispensing chamber are disposed within a cavity of the manifold in fluid communication with the two component reservoirs. After initial use, if clogging and/or increased resistance to flow is detected by the user, the integral mixing and dispensing chamber is simply removed from the flow path and a new integral mixing and dispensing chamber is installed in the manifold in its place. In this manner, initial mixing can take place proximally in the flow path and subsequent mixing can occur along the flow path through the distal portion of the mixing and dispensing chamber. At a distal end of the manifold assembly, an atomizer structure is alternatively provided for converting the mixed adhesive into a spray. It is also envisioned that the mixing and dispensing chamber can be made in a variety of configurations and lengths to facilitate remote application of mixed adhesive such as, e. g. in endoscopic or laparoscopic procedures.

It is also envisioned that a self contained magazine of integral mixing and dispensing chamber may be provided in a configuration wherein a series of new integral mixing and dispensing chamber is sequentially advanced into alignment with the flow path as directed by the user.

BRIEF DESCRIPTION OF THE DRAWINGS Various embodiments are described herein with reference to the drawings, wherein: FIG. 1 is a side view in cross section illustrating an elongated manifold in accordance with one embodiment of the present disclosure; FIG. la is a side view in partial cross section of an integral mixing and dispensing chamber to fit within and for using with the manifold of FIG. 1; FIG. 2 is a side view in cross section illustrating a manifold assembly with the integral mixing and dispensing chamber of FIG. la installed therein; FIG. 3 is a side view in cross section illustrating a manifold assembly in accordance with another embodiment; FIG. 4 is a side view in partial cross section with parts separated of a dispenser and an integral mixing and dispensing chamber in accordance with an alternate embodiment; FIG. 5 is a side view of the dispenser of FIG. 4 with the integral mixing and dispensing chamber installed.

FIG. 6 is a side view of a dispenser in accordance with another alternate embodiment; FIG. 7 is a side view of a magazine loaded with multiple integral mixing and dispensing chamber; and FIG. 8 is a side of the dispenser of FIG. 6 with the magazine of FIG. 7 connected thereon.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS Referring to FIGS. 1-2, a dispenser manifold assembly referenced generally as 50 is shown. The manifold assembly 50 includes a manifold 10 and a disposable mixing and dispensing chamber 20. Manifold 10 includes a manifold base 52 and a guide 54 detachably connected thereon. At a proximal end of the manifold 10, two conduits 56, 58 separately convey the adhesive components from their respective reservoirs (not shown) to a cavity 66 formed in the manifold 10. The proximal end of the manifold 10 may further include connections 60,62 in fluid communication with the respective conduits 56,58 for facilitate connection to the reservoirs.

An integral mixing and dispensing chamber 20 is configured and dimensioned to be positioned with cavity 66 in direct fluid communication with conduits 56,58. See, FIG. 2. In operation, the two separate components are fed into the mixing chamber portion 70 of the mixing and dispensing chamber 20 where they are mixed thoroughly. A baffle structure 72 of known type may be placed within the mixing chamber portion 70 to facilitate the mixing. Thereafter, the mixed adhesive is conveyed down the dispensing conduit portion 74 under pressure and is expelled out the distal end of the manifold 50. It is envisioned that the distal end of the manifold may be equipped with an outlet port or orifice 76 for affecting the dispensing of the adhesive. In addition, the distal end may incorporate a spray head or a drip type structure.

FIG. 3 illustrates another embodiment of the present invention, which is similar in structure except the distal portions of the manifold 10 and the mixing and dispensing chamber 20 of FIGS. 1-2. Manifold guide 78 is configured in a shorter length than the manifold guide 54 described herein above. In addition, a distal portion of the mixing and dispensing chamber 80 protrudes out from the distal end of the guide 78. An outlet port or spray nozzle 82 is disposed at the distal end of the mixing and dispensing chamber 80.

FIG. 4 illustrates a dispenser 100 including a component supply system of known type and incorporating a shorter manifold 84 configured and dimensioned to receive an integral mixing and dispensing chamber 88. This embodiment is substantially similar to the manifold assembly 50 of FIGS. 1-3 with the exception that the dispensing conduit portion 90 is somewhat shorter. Referring to FIG. 5, as in the embodiment described above, the separate components of the adhesive or synthetic sealant are fed to the mixing chamber portion 92 where they are thoroughly mixed.

Thereafter the mixed adhesive is conveyed under pressure along the dispensing conduit portion 90 to a distal opening 86 in the manifold 84.

FIG. 7 illustrates a magazine 110 configured and dimensioned to sequentially hold a plurality of mixing and dispensing chambers 88. In a preferred embodiment, as depicted in FIG. 6, manifold 94 is configured to receive magazine 110 in a manner wherein the user can apply pressure to pusher 116 to advance a new mixing and dispensing chamber 88 into fluid communication with the component conduits while simultaneously ejecting the old mixing and dispensing chamber. The magazine 110 includes a container 112 for receiving the plurality of mixing and dispensing chambers 88 therein and defines an opening 114 for taking the plurality of the mixing and dispensing chambers and advancing a new mixing and dispensing chamber into an opening 96 of the manifold 94. Thus, as one begins to clog, simply by pressing pusher 116, a new one is brought into line.

It is envisioned that any commercially suitable material known in the art can be used to form the manifold assembly including the mixing and dispensing chamber as described in various embodiments herein above. It is also envisioned that at least some portion of the manifold and/or mixing and dispensing chamber may be formed from transparent material to monitor clogging therein.

While the above description contains many specifics, these specifics should not be construed as limitations on the scope of the disclosure, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision many other possible variations that are within the scope and spirit of the disclosure as defined by the claims appended hereto.