VIAL COUPLER ' . ■ . ■
This application claims priority from applicants' provisional application 60/174,637, filed January 5, 2000.
BACKGROUND
I. Technical Field
This disclosure relates to a vial coupler apparatus that mechanically mates and fluidly connects vials with a multiple syringe apparatus for the dispensing of a protein solution. Different standard sized vials may be emplaced within the vial coupler for preparing, mixing, and transferring independent solutions, such as protein solutions, to the multiple syringe apparatus. ■ 2. Description of Related Art
Devices for using two component liquid medical treatments are commonly adapted to transfer, mix, and dispense liquids such as a fibrin sealant. Fibrin is a biological adhesive formed by mixing two protein components, namely, fibrinogen and thrombin. Each
protein component is derived from human plasma and is subjected to virus elimination procedures. "The components are typically individually dehydrated and stored in separate standardized 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 sealant having great potential benefit, both as a hemostatic agent and as a tissue adhesive. 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 to a dispenser that applies the two separate protein solutions simultaneously.
International application No. PCT/US98/26688 to Roby et al. describes a fibrin
mixture and dispenser assembly for mixing a first protein component with sterile water to form a first protein solution and for dispensing the firsfprotein solution. The first protein solution forms
a biological adhesive when intermixed with a second protein solution on an application site. The second protein solution is preferably mixed and dispensed by a similar fibrin mixture and dispenser assembly. The two fibrin mixture and dispenser assemblies can be housed within a single housing. This PCT application is hereby incorporated into this application by reference. International application No. PCT/US98/27079 to Roby et al. describes two applicator embodiments for dispensing a first and a second protein solution to form a biological adhesive. In the first embodiment, the protein solutions can be deflected during dispensing in order for the adhesive to cover a broad area. The applicator includes a housing configured to receive a plurality of reservoirs each having a sealable opening therein; a conduit assembly having a pair of conduits in respective fluid communication with separate reservoirs; an activator assembly provided on the housing having an activator moveable from a first position to a second position to pressurize each of the plurality of reservoirs to dispense the biological adhesive
components through the pair of conduits to a distal end thereof; and a deflection member to deflect the biological adhesive components during dispensing. This PCT application is hereby
incorporated into this application by reference.
Accordingly, a need exists for an improved apparatus for the sterile transferring of fluids between different sized vials and a loading unit that is simple, reliable, reduces the risk of contamination due to impurities, and easily communicated to a dispensing apparatus.
SUMMARY A vial coupler having at least one adapter ring is provided for the transfer of fluids between fluid containment devices. In particular, the vial coupler provides for the sterile transfer
of fluids from a first set of two vials in a first receptacle to a loading unit in a second receptacle.
The first set of two vials are then withdrawn with their adapter rings. The adapter rings engage
the smaller diameter caps of the first standard vials and prevent the premature engagement of the
sharp with the larger diameter caps of the second standard sized vials containing a biological component. The vial coupler then can accommodate and provide for the transfer of the fluid
from the loading unit to a second set of two vials containing components of a biological
adhesive. The biological adhesives and fluid are mixed in the second set of vials and then
transferred through the vial coupler back to the detachable loading unit for dispensing. The first and second receptacles of the vial coupler are divided by a septum having sharps on the vial side and fluid outlets on the loading unit side.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are presented to provide further information on the invention as claimed. BRIEF DESCRIPTION OF THE DRAWINGS
Various embodiments are described herein with reference to the drawings, wherein:
FIG. 1 is an enlarged perspective view of one embodiment of the vial coupler;
FIG. 2 is an enlarged cross sectional view of one embodiment of the vial coupler
with one first standard sized vial emplaced in an adapter ring within a receptacle and another first standard sized vial removed from within the receptacle retained on the cap;
FIG. 3 is an enlarged elevated perspective view of an adapter ring; FIG. 4A is an enlarged elevated front perspective view of the loading unit in an extended position;
FIG. 4B is an enlarged elevated perspective view of one embodiment of the vial coupler; and
FIG. 5 is an enlarged perspective view with a partial cross section of one
embodiment of the vial coupler with one second standard sized vial emplaced in a receptacle, another second standard sized vial about to be emplaced in receptacle, and a loading unit installed.
DETAILED DESCRIPTION
Referring now to FIG. 1, a vial coupler 100 is disclosed that includes a housing or
body 125 composed of a first side 110 and a second side 120. Housing 125 is preferably made of
a rigid medical grade plastic, but other medical grade materials are also envisaged such as e.g.
stainless steel, titanium, different plastics, etc. Vial coupler 100 contains a first portion with a
first set of at least two receptacles 140 and a second portion with a second set of at least two receptacles 180. In its present configuration, housing 125 has a septum 150 that divides the first
set receptacles 140 from the second set of receptacles 180. Each receptacle 140 is configured with an adapter ring 160 and a sharp 152 that is positioned to provide a fluid connection through septum 150. A pair of opposing adapter ring release levers 122 are on first side 110 and second
side 120. A loading unit release lever 130 is located on the lower portion of vial coupler 100, adjacent receptacle 170. Housing 125 also defines four sets of through holes 124 for assembling first side 110 and second side 120 together with mechanical devices 126 in common usage such
as bolts, machines screws, and nuts. Other housing 125 and septum 150 configurations and means of assembly are envisioned to include a single monolithic structure, bonded materials, or
self locking tabs.
In FIG. 2, a first set of two standard sized single dose vials 190 are sealed by a cap 192 that is approximately 0.68 inch in diameter with a center of resilient penetrable material 194. As cap 192 is emplaced into receptacle 140, it begins to engage adapter ring 160 that is positioned approximately at the base of receptacle 140 and aligned by at least one tab 162. When cap 192 is fully seated into adapter ring 160 and becomes fixedly engaged therewith, sharp 152 has penetrated through penetrable material 194 and fluid communication is established between sharp 152 and vial 190. While the present embodiment describes a first set of vials 190 as single dose vials with a cap 192 of an approximate size, it should be understood that the vial coupler 100 receptacle and adapter ring 160 are capable of being sized to interface with a broad range of standard and non-standard container sizes to support a variety of functions and the applications
of this device are not limited to coupling components of biological adhesives or to the specific
disclosed sizes of containment devices.
Referring now to FIGS. 2 and 3, adapter ring 160 is made of medical grade plastics and has a circular band shape. In the present configuration, two opposing positioning
tabs 162 establish the alignment of adapter ring 160 between receptacle 140 and lateral axis 166. Adapter ring 160 defines a hole 164 with a central longitudinal axis 165 which is aligned with
the emplacement of cap 192. Lateral axis 167 is perpendicular to lateral axis 166. Axes 166 and
167 are perpendicular and coplanar to longitudinal axis 165. Adapter ring 160 has at least one slot 168 and at least one partial cut out 170 which provides, strain relief and results in additional
flexibility. The requirement for slots 168 and cut out 170 is dependent upon the material characteristics of adapter ring 160. Adapter ring 160 defines a lip 172 with two inward directing
protrusions which are positioned as retaining tabs 174 for cap 192. Tabs 174 are positioned at
the intersection of axis 167 and adapter ring 160, the quantity, size, and location of retaining tabs
is a function of the configuration of the cap that it is intended to engage and be retained with after
removal from receptacle 140. As vial 190 is emplaced into adapter ring 160, lip 172 is forced to extend outward in an arcuate manner along lateral axis 167 to fit cap 192 within the inside circumference of tab 174 of lip 172. In this process, the area between each positioning tab 162 and the bottom of slot
168 flexes, acting as an axis of rotation, for the arcuate movement of lip 172. Once retaining tab= 172 goes past cap 192, lip 172 returns to its initial position due to its bias and retaining tab 172 locks around cap 192.
As shown in. FIGS. 4A and 4B, loading unit 50 contains a reservoir assembly 52 and a dispensing assembly 54 that provides the pressure required for application. Front 56 of
dispensing assembly 54 defines a hole 58 that provides a locking mechanism with vial coupler
100. Each loading device 55 contains a cone shaped tip 60 with a resilient coating 62 on the surface. Each cone shaped tip 60 defines a circular, hole 57 that is connected to reservoir
assembly 52 and through which fluids are loaded and dispensed. Loading unit 50 is made of a
rigid medical grade plastic. Loading unit 50 preferably contains two dispenser devices 55, but
can be configured with any number of dispenser devices 55 or different sizes of dispenser devices to engage with the at least two receptacles 180 of vial coupler 100.
The second portion of vial coupler 100 contains the set of at least two receptacles 180 for interfacing with at least two loading devices 55 and front 56 of loading unit 50. In the present configuration, the second portion contains two receptacles 180 with two fluid outlets 154 that are at the opposing ends of sharps 152 (See FIG. 5). Septum 150 provides a conical receptacle 156 for engaging cone 60 of loading device 55. In the present configuration, septum
150 is made of a resilient medical grade plastic, but could be made of any medical grade material. Circular hole 57, at the end of each cone 60 of loading device 55, is positioned to make a seal around and establish a fluid connection with fluid outlet 154. Housing 125 contains loading unit release lever 130 which is connected to a tab 112 that contains a lip 114. As front 56 of the loading unit 50 is emplaced into receptacle 180, lip 114 of tab 112 is positioned to pass through hole 58 and lock with front 56 of dispenser assembly 54. This locking action provides the force necessary to sustain a seal between fluid outlet 154 and hole 57. Referring now to FIGS. 2, 3, and 5, when a sufficient quantity of sterile water is withdrawn from vials 190 through vial coupler 100 into loading unit 50, then vials 190 can be removed from vial coupler 100. Vials 190 can be pulled directly from their emplacement without any additional steps. The force to remove vial 190, now with adapter ring 160 attached, may be reduced by simultaneously pressing inwardly adapter ring release lever 122. Forcing release levers 122 together simultaneously compresses adapter ring 160 along axis 167, at the point where retaining tabs 174 are located, and enhances the retentive ability of adapter ring 160
to lock with cap 190 as it is being withdrawn from vial coupler 100. Vial 190 with adapter ring 160 can then be discarded.
Second standard sized vials 200, in this embodiment, contain second components, such as fibrinogen and thrombin as sterile freeze-dried powders. A cap 202, approximately 0.82 inch in diameter seals vial 200 and has a resilient penetrable material 204 in its center that can be pierced by sharp 152. When adapter ring 160 is positioned inside receptacle 140, second standard sized vial 200 is precluded from engaging sharp 152 because the diameter of cap 202 exceeds the diameter of adapter ring 160 sufficiently that it blocks any further movement into receptacle 140. When adapter ring 160 is removed with vial 190 from vial coupler 100, second standard sized vial 200 with larger diameter cap 202 can now be fully emplaced into receptacle
140 and penetrated by sharp 152.
In the present embodiment, when vials 200 are engaged by sharp 152 a controlled
quantity of sterile water from loading unit 50 can then be dispensed through vial coupler 100 into
vials 200 of fibrinogen and thrombin. Once the sterile water is sufficiently mixed within the individual second vials 200 of fibrinogen and thrombin, they can then be transferred through vial coupler 100 into loading unit 50 for dispensing as protein solutions. Loading unit 50 is then
disconnected from its engagement with lip 114 of vial coupler 100 by pressing loading unit release lever 130 and withdrawing loading unit 50 from receptacle 180. Dispensing is accomplished by forwarding the reservoir assembly 52 relative to dispensing assembly 54 to force the simultaneous dispensing of the two protein solutions.
Although the illustrative embodiments of the present disclosure have been
described herein with reference to the accompanying drawings, it is to be understood that the
disclosure is not limited to those precise embodiments, and that various other changes and modifications may be affected therein by one skilled in the art without departing from the scope
or spirit of the disclosure. All such changes and modifications are.intended to be included within
the scope of the disclosure.