CA2050735A1 - Adapter for diluent container - Google Patents

Abstract

ADAPTER FOR DILUENT CONTAINER
Abstract of the Disclosure An adapter for easily and securely connecting a standard size medicament vial to the flexible diluent container. The adapter has a sleeve for supporting the vial and a cannula for penetrating the vial stopper, and has a threaded neck for engaging a threaded port on the diluent container. A cap in the adapter neck interlocks with a cover on the container port whereupon withdrawal of the port cover withdraws the adapter cap and allows the medicine to flow from the vial to the diluent container.

Description

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ADAPTER FOR DILUENT CONTAINER

Field of the Invention:
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The adapter of the present invention is directed to the mixing of a substance in a viAl with another sub-~tance in a flexible container. Specifical:Ly, this adapter is designed to allow a standard sized vial to be attached to a diluent container that was designed for at~achment to a specially designed vial.
Background of the Invention~
A system for mixing a drug with a diluent has been available. In particular, Abbott Laboratories, the assignee of the present invention, has manufactured an~
marketed such a system under the trademark ADD-VANTAGE~.
U.S. Patents No. 4,614,267, 4,614,515, 4,784,259, and c~ O
4,784,658 illustrate variations of $his ADD-VAN~AGE
System, all of the patents having been assigned to Abbott Laboratories.
This ADD-YANTAGE System incorporates a specifi-cally designed vial that can be attached to a specifically designed diluent container. The vial has a vial opening that is closed by a removable stopper. The flexible diluent con~ainer incorporates a generally rigid port sleeve. There are internal threads in the sleeve and the neck of the vial has complementary external threads.
Within the flexible diluent con~ainer, there is a remov-able port cover having a plug that extends toward the entrance to the port sleeve in the path of a vial being . .

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threaded into the port sleeve. The stopper on the vial has a recess for receiving the port plug and there are complementary shoulders on the port plug and the inner surface of the stopper recess that are sn~pped into engagement when the ~ial is threaded into the port sleeve. Subsequent withdrawal of the port cover by manual squeezing of the 1exible side walls of the container will withdraw with it the vial stopper, allowing the content~
from the vial to enter the flexible container and mix with a diluent therein.
In the existing ADD-VANTAGE System, because the diluent container was designed for attachement to a specially designed vial, it cannot be attached to a standard 20 millimeter vial and, but for the present invention, the standard 20 millimeter vial would require a differPnt style of diluent container. An object of the present invention is to provide an adapter by which a standard 20 millimeter vial can be connected to a diluent container that was designed for a different vial.

(b) Prior Art:
Aalto et al Patent No. 4,607,671 discloses a device 10 for communicating a vial 12 with a second container 14. The device 10 includes a sheath skirt 74 that extends from a base 72 across the middle of the device. A plurality of bumps 82 project inwardly from the interior wall 78 of the skirt 74. A double-pointed needle 54 extends through the base 72 and projects into the area surrounded by the sheath skirt 74. As a vial 12 is 20~0735 .
inserted into the area surrounded by the skirt 74, the needle 54 pierces the seal 20 of the vial and the bumps 82 engage with the underside 23 of the band 24 and hold the device in place on the vial.
The Aalto patent does not incorporate a stopper and externally threaded neck structure at the opposite end of an adapter that adapts a vial to be threaded onto the port of a diluent container.
Sardam Patent NQ . 4,735,608 discloses a container 32 for intravenous fluids. ~he container has a neck portion 44 with a channel 46 extending through the neck.
Threads or ribs surround the external surface 48 of the neck and engage with matching ribs 52 of an intermediate member 54 positioned on the neck. A cross plate 56 extends across the interior on the neck. A cross plate 56 extends across the interior of the intermediate member and supports a hollow spike ~8. A pair of ducts 64, 65 pass through the spike. The member 54 includes a pair of ribs 66, 68 that guide and hold the neck of a vial inserted into the intermediate member. As the vial is inserted, the spike pierces the seal of the vial and the ribs hold the vial in place on the intermediate member. There is no disclosure in the Sardam patent of a stopper and external threaded neck structure at the opposite end o an adapter which adapts a vial to be threaded to the port of a diluent container.
To avoid jeopardizing the sterility of the vial, stopper, or medicament, the vial must not become separated 2~735 .
from the con~ainer. Because of the very nature of hospitals, the connection between vial and container must be strong. For example, it is not uncommon for patients ---to be in extreme pain and become very physical. Under these circumstances abnormal forces may be i~pplied, albeit unintentionally, toward separation of the vial from the diluent container. Also, emergency situations arise where significant numbers of hospital personnel are requixed to render aid to a patient who may already have an I.V. or the personnel may be attempting to install an I.V. Both of these scenarios lead to the conclusion that an inadver-tent disconnection of the I.V. components may occur because of the concentrated physical activity which occurs in the near vicinity of the patient. In addition to the exposure to contamination, an inadvertent disconnection of components may be potentially hazardous in that it opens the reconstitution system thus exposing pharmacists, technicians, physicians, or nurses to potentially toxic medicinal agents through ~aerosoling~ or other contact with the drug~
It is an advantage and objective of the present invention to provide an adapter that is not subject to the aforementioned limitations and disadvantages of the prior art.
Additional objectives of the present invention are to provide an adapter which allows a standard drug vial to be used with an existing diluent container wherein the adapter is easy to use and minimizes the possibility-- 2~7~
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of accidental contamination of the fluids to be injected into a patient.
Another object of the present invention is to provide an adapter that reduces the waste of expensive drugs. Using the adapter of the present invention, a drug may be mixed with a diluent immediately prior ~o a scheduled injection, such as at the patient's bedside, avoiding early mixing of the drug and the diluent. In this connection, it is a characteristic of certain anti-biotics to remain stable for extended periods of time only in the solid state; once dissolved in the diluent, ~hey must be immediately injected or refrigerated.
Other objects and advantages of the present invention will be apparent from the detailed description of the invention.
SummarY of the Invention The adapter of the present invention allows a pharmacist to connect a conventional 20 millimeter vial with an existing ADD-VANTAGE diluent container of the kind having a generally rigid port. Toward this end, the adapter comprises a sleeve like body that has a cavity for receiving a standard 20 millimeter vial. Within the cavity, there is a central cannula for puncturing the stoppe~ of the vial. The adapter cavity has an annular shoulder that is complementary to an annular shoulder behind a rim on the vial. When the vial is pressed into the vial receiving cavity of the adapter, these compli-mentary annular shoulders lock the vial into place as, . ~

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simultaneously, the cannula penetrates the vial stopper and establishes communication with the medicament within the vial.
Opposite the vial receiving cavity, a neck area of the adapter has a recess within which a removable cap is fitted. The outer wall of the neck area has external threads that are complimentary to internal threads on the port of the diluent container. ~he removable adapter cap has a recess in it with an annular rim. A shoulder behind this rim is complimentary to a shoulder on a plug on the cover of the container port. Upon threadi.ng of the adapter into the container port, the plug enters the adapter recess an~ snaps in place. Thereafter, manual flexing of the side wall of the container allows with-drawal of the port cover from the container port.
Withdrawal of the container port pulls the adapter cap from the adapter recess, allowing the medicament to flow from the vial through the cannula mix with the diluent in the diluent container.
Thus, the adapter of the present invention allows the secure attachment of a standard vial to a diluent container in a tight fit so as to minimize the possibility of inadvertent disconnection of the device from the diluent container. Accordingly, a safer I.V. system is obtained based upon securely connected components.
Description of the Drawings:
Figure 1 is a perspective view of the adapter shown connected to a vial.

7 ~ ~ -Figure 2 is a view in longitudinal medial sec~ion through the adapter.
Figure 3 is an enlarged view in longitudual medial section illustrating attachment of the adapter to a drug vial and to a flexible diluent container;
Figure 4 is a view in section similar to that of Figure 3 but illustrating withdrawal of the container cover and adapter cap.
Description of the Preferred Embodiment.
This adapter 10 is for use with a diluent container 12 and a standard 20 millimeter vial 14. The diluent container 12 is of a known kind having a flexible bag 16 with an opening that is defined by a generally rigid port sleeve 18. Adjacent its mouth 20, the port sleeve 18 has a plurality of circumferentially spaced ratchet ribs 22 and further inward, the port sleeve 18 has internal thrsads 24.
A port cover 26 is resiliently held on the end 28 of the port sleeve 18 by an annular detent locking arrangement 30, and an outer peripheral wall 32 on the port cover 26 enables withdrawal of the port cover 26 from the sleeve 18. Centrally, the port cover has a port plug 34 projecting toward the mouth 20. The port plug 34 has an enlarged head 36 on it defining an annular shoulder 38.
The known diluent container 12 incorporates the foregoing structure and features. The 20 millimeter vial will now be described.

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The vial 14 has a stopper 40 in lt. The medicine in the vial 14 can be released upon removal or puncturing of the vial stopper 40. The vial 14 also has a rim 42 around its open end that defines a peripheral radial shoulder 44.
Turning now tothe adapter 10, it may be formed of a generally rigid and resilient plastic material, such as molded polypropylene or ABS plastic. The adapter lO has a side wall 48 that surrounds a vial cavity 50 and has a neck 52 that surrounds an outlet recess 54. A web 56 between the two recesses has a cannula 58 projecting from it into the vial cavity 50. There is a passage 60 through the cannula 58. Radially outwardly from the cannula 58, an annular shoulder 62 is formed on the inside of the wall 48 at the end of an annular r~mp 63. On the outside ~urface of the wall 48, there are radial ratchet teeth 64 that complement the ratchet ribs 22 in the port sleeve 18.
The neck 52 of the adapter 10 is formed with external threads 66 for threading into the internal threads 24 of the port sleeve 18. An adapter cap 68 fits tightly within the outlet recess 54 to maintain a liquid tight seal unless the adapter cap 68 is removed. The adapter cap 68 has a cavity 70 in it with a mouth 72 of reduced diameter to define an annual shoulder 74.
The adapter sleeve may be molded with an integral loop 76 on its side defining an opening 78. The ring 76 allows the adapter to be hung on a pole.

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Operation:
When a 20 millimeter vial 14 is introduced into the vial cavity 50, the vial rim 42 contacts the annular ramp 63, temporarily expanding the diameter of the side- :
wall 48 and enabling the vial rim 42 to pass through the opening defined by the annular shoulder 620 Simultan-eously, the point of the cannula 58 penetrates the vial stopper 40. When the rim 42 of the vial 14 clears the annular shoulder 62, the ~idewall 48 contracts to its normal shape, positioning the annular shoulder 62 of the adapter directly behind the radial shoulder 44 of the vial. At this point, the contents of the vial 14 can flow through the passage 60 in the cannula, but release of these contents is blocked by the adapter cap 68~ Now, the adapter 10 carrying with it the vial 14 is threaded into ths port sleeve in much the same manner as is conventially done with a larger ~ial in the aforesaid ADD-VANTAGE
System. The external threads 66 on the adapter neck 52 are threaded into the internal threads 24 of the port sleeve 18. This introduces the plug 34 into the cavity 70 of the adapter cap 68. Further threading causes the enlarged head 38 to expand the mouth 72 of the adapter cap 68 until the port plug clears the mouth 72, at which time the shoulder 74 on the adapter cap snaps into pace behind the enlarged head 36 in contact with annular shoulder 38 on the port sleeve 18.
Upon squeezing the flexible side wall 16 of the diluent container 12, the outer peripher~l wall 32 of the 2 ~ 3 ~
-" . "' port cover 26 can be grasped manually and withdrawn from the inner end 28 of the sleeve 18, drawing with it the adapter cap 68. This releases the contents of the vial 14 into the diluent within the container 16.
There are various changes and modifica-tions which may be made to the invention as would be apparent to those Rkilled in the art. However, these changes or modifica-tions are included in the teaching of the disclosure, and it is intended that the invention be limited only by the scope of the claims appended hereto.
What is claimed is:

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Claims (9)

1. An adapter for securely connecting a medicament vial to a port of a diluent container, said device comprising:
a. a sleeve for surrounding a medicament vial;
b. An externally threaded neck on the sleeve for threaded connection to the diluent container port;
c. means for transferring the contents of the vial to the diluent container;
d. rib means internal to the sleeve for retaining the medicament vial, said rib means securing the vial by engaging the recess means on the vial which circumscribes the vial;
e. and a series of splines circumscribing the sleeve which engage a similar series of splines on the container port.

2. The adapter as claimed in claim 1 wherein the internal configuration of the adapter includes a ramp surface slideably engageable by the vial for expanding the rib means and thereafter releasing the rib means to engage the recess means.

3. The adapter as claimed in claim 1 wherein said means for transferring the contents of the vial to the container comprises a rigid hollow needle, said needle being supported by the adapter.

4. An adapter having a hollow needle for transferring a medicinal agent from a medicament vial to a diluent container, the adapter having a sleeve for positioning and supporting the medicament vial, a neck on the adapter having threads engageable with threads on a port of the diluent container for secure attachment of the adapter to said diluent container to thereby make difficult the inadvertent disconnection of said adapter and diluent container.

5. The adapter of claim 4 further comprising an annular rib means internal to the sleeve for engaging beneath an annular band means of the medicament vial to secure the vial within the sleeve.

6. The device of claim 5 wherein the rib is concentric with the sleeve and is continuous so as to securely retain the medicament vial.

7. An adapter for connecting a standard vial to a diluetn container comprising:
a. a sleeve on the adapter for supporting the vial, b. a cannula supported by the adapter within the sleeve for penetrating a stopper in the vial, c. means for positively locking the adapter to the diluent container, d. a removable cap on the adapter, e. means for interlocking the cap with a cover on the diluent container whereby withdrawal of the cover withdraw the cap and allows medicine to flow from the vial to the diluent container.

8. The adapter of claim 7 including a recess in the cap for receiving a plug projecting from the cover and wherein the interlocking means comprises complimentary overlapping shoulders on the plug and within the recess.

9. The adapter of claim 7 wherein the locking means comprises complimentary threads on the adapter and the diluent container.