WO2001049361A1

WO2001049361A1 - Vial coupler

Info

Publication number: WO2001049361A1
Application number: PCT/US2001/000373
Authority: WO
Inventors: Clifford L. Emmons; Donald S. Wilson
Original assignee: United States Surgical, A Division Of Tyco Healthcare Group Lp
Priority date: 2000-01-05
Filing date: 2001-01-05
Publication date: 2001-07-12
Also published as: AU2765401A

Abstract

The vial coupler (100) is configured to engage and provide a connection for the sterile transfer of fluid between different standard sized vials (190, 200) and a loading apparatus (50). In the present configuration, receptacles (140) for two vials (190, 200) are provided, and each receptacle (140) contains an adapter ring (160) that locks onto the cap (192) of a first standard sized vial (190), but precludes the premature emplacement of a larger diameter cap (202) of a second standard sized vial (200). The first standard size vials (190) contains a first component while the second standard size vials (200) contains a second component. Once the first component is transferred from the first standard vials (190) through the vial coupler (100) to the loading unit (50), the first standard size vials (190) and adapter rings (192) are withdrawn from the vial coupler (100). The receptacles (140) of the vial coupler (100) can then accomodate the larger diameter vial caps (202) of the second standard sized vials (200). The first componentis then transferred from the loading unit (50) through the vial coupler (100) and into the second standard size vials (200). The solution of the first and second standard components is then withdrawn through the vial coupler (100) into the loading unit (50) and subsequently dispensed therefrom.

Description

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.

Claims

WHAT IS CLAIMED IS

1. A coupling apparatus comprising: a body defining first and second receptacles in fluid communication, the first receptacle having a first inner diameter; and

an adapter ring releasably positioned within the first receptacle, the adapter ring having a second inner diameter smaller than the first inner diameter and dimensioned to

accommodate a portion of a first vial having a first outer diameter, wherein upon removal of the

adapter ring from the first receptacle, the first receptacle is able to accommodate a portion of a

second vial having a second outer diameter larger than the first outer diameter.

2. The coupling apparatus of claim 1, wherein the first receptacle is configured with positions to simultaneously receive at least two first vials and upon removal of the at least two

first vials, receive at least two second vials.

3. The coupling apparatus of claim 2,' wherein the first receptacle includes a plurality of adapter rings.

4. The coupling apparatus of claim 3, wherein the plurality of adapter rings are configured to engage a first vial and be released from the receptacle when the first vial is removed.

5. The coupling apparatus of claim 1, wherein the adapter ring is configured to engage a cap of the first vial having the first outside diameter and the adapter ring is configured to

preclude engagement of a cap of the second vial having the second outside diameter, wherein the

second outside diameter is larger than the first outside diameter.

6. The coupling apparatus of claim 1, wherein the adapter ring has positioning tabs retaining the adapter ring in position in the first receptacle.

7. The coupling apparatus of claim 1, wherein the adapter ring includes a bias configured to assist the adapter ring in engaging a portion of the first vial.

8. The coupling apparatus of claim 7, wherein the bias of the adapter ring returns the adapter ring to a first position, the adapter ring in the first position being configured and dimensioned to receive a cap of the first vial and in the second positions the adapter ring expanding to accommodate the outside diameter of the cap of the first vial, the adapter ring then being biased to the first position locking at least partially around the cap of the first vial.

9. The coupling apparatus of claim 1, wherein the adapter ring includes retaining tabs extending radially from the inside diameter of the adapter ring to lock at least partially around the

cap of the first vial.

10. An assembly for mixing and applying components of a biological adhesive

comprising:

a first vial defining a cap having a first outside diameter; a second vial defining a cap having a second outside diameter, the second outside

diameter being larger than the first outside diameter; a vial coupler including a body having a first portion defining at least two receptacles and a second portion defining at least two opposing receptacles; a sharp positioned in each receptacle of the first portion providing fluid communication with an outlet defined in the opposing receptacle of the second portion; an adapter ring positioned in each receptacle of the first portion configured

and dimensioned with an inside diameter for receiving the first vial cap and positioning the first

vial cap for fluid communication with the second portion, the adapter ring configured and

dimensioned for precluding reception of the second vial cap and fluid communication with the second receptacle;

a loading unit including a reservoir assembly and a dispensing assembly; at least two reservoirs defined in the reservoir assembly for temporarily

storing fluids in a sterile environment; and at least two dispensing devices positioned in the dispensing assembly engaged with the reservoir assembly, the dispensing assembly configured for positioning with the outlets defined in the at least two receptacles of the second portion and for defining a

passageway from a tip of the dispensing devices to the at least two reservoirs.

11. The assembly for mixing and applying components of claim 10, wherein the first vial

is a standard size single dose vial.

12. The assembly for mixing and applying components of claim 10, wherein the adapter

ring has positioning tabs retaining the adapter ring in position in the first receptacle.

13. The assembly for mixing and applying components of claim 10, wherein the adapter

ring includes a bias, wherein the bias is configured to assist the adapter ring in engaging at least

partially around the outside of a portion of the first vial.

14. The assembly for mixing and applying components of claim 10, wherein the loading unit is configured to simultaneous dispense components of a biological adhesive from the

dispensing devices by compressing the reservoir assembly into the dispensing assembly.

15. A method for mixing and dispensing components of a biological adhesive

comprising the steps of: providing a vial coupler and a loading unit, the vial coupler defining a first

receptacle which is configured to receive a portion of first and second sets of vials in sequence

for the transferring of fluids in a sterile environment between the loading unit and the first and second sets of vials, the loading unit defining at least two reservoirs in a reservoir assembly and a dispensing assembly configured for receiving and dispensing fluids, the dispensing assembly including at least two dispensing devices configured to engage with a second receptacle of the vial coupler; positioning the first set of vials containing sterile water in the first receptacle of the vial coupler and transferring sterile water from the first set of vials to the loading unit connected to the second receptacle, the vial coupler being configured to initially only receive the

first set of vials for fluid communication with the second receptacle;

removing the first set of vials from the first receptacle and mounting the second

set of vials in the first receptacle containing components of a dehydrated biological adhesive for fluid communication with the second receptacle and transferring the sterile water from the

loading unit to the second set of vials, mixing the sterile water with the components of the

dehydrated biological adhesive; and transferring the hydrated components of the biological adhesive from the second

set of vials to the loading unit and disengaging the loading unit to dispense the components of

the biological adhesive.

16. The method for transferring and dispensing fluids of claim 15, wherein the step of positioning further includes establishing fluid communication between the first set of vials and the loading unit positioned in the second receptacle.

17. The method for transferring and dispensing fluids of claim 15, wherein the step of transferring the fluid from the first set of vials to the loading unit includes repositioning a portion of the loading unit to draw fluid from the first set of vials through the vial coupler into the

loading unit.

18. The method for transferring and dispensing fluids of claim 15, wherein the step of

removing the first set of vials includes removing at least one adapter ring from the vial coupler.

19. The method for transferring and dispensing fluids of claim 15, wherein the step of transferring the fluid from the loading unit further includes repositioning the reservoir assembly relative to the dispensing assembly to dispense the components of a biological adhesive from the at least two dispensing devices.