CA2094329A1 - Flow adapter for drug vial - Google Patents

Flow adapter for drug vial

Info

Publication number
CA2094329A1
CA2094329A1 CA 2094329 CA2094329A CA2094329A1 CA 2094329 A1 CA2094329 A1 CA 2094329A1 CA 2094329 CA2094329 CA 2094329 CA 2094329 A CA2094329 A CA 2094329A CA 2094329 A1 CA2094329 A1 CA 2094329A1
Authority
CA
Canada
Prior art keywords
adapter
vial
cannula
fluid
hollow portion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
CA 2094329
Other languages
French (fr)
Inventor
John S. Ziegler
Mark E. Larkin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abbott Laboratories filed Critical Abbott Laboratories
Publication of CA2094329A1 publication Critical patent/CA2094329A1/en
Abandoned legal-status Critical Current

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  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

ABSTRACT
The present invention relates to an adapter for a drug vial of the type having a pierceable stopper closing an open end of the vial. The adapter is to be used for fluid connection with various fluid delivery systems. The adapter includes ahousing having a hollow portion including an opening at the first end, a second open end and a fluid passageway therebetween. The first end includes a sharp piercingpin. An axial slot is associated with the opening at the first end of the hollow portion for minimizing the fluid residual in the vial when the vial is inverted for fluid delivery.

Description

2~9 i~32~
51 66.US.01 FLOW ADAPTER FOR DRUG VIAL
FIELD OF THE INVENTION
The present invention relates generally to a fluid flow-adapter for a drug vial and more particularly to an adapter which maximizes the cumulative fluid flow from the vial to a connected fluid delivery system.
BACKGROUND OF THE INVENTION
Small quantities of drugs have traditionally been packaged in small volume glass vials sealed by a pierceable stopper. These 10 and 20 ml vials are often referred to as unit dose vials. The drug in the vial is traditionally withdrawn from the vial by use of a syringe having a sharp metal needle or cannula. A drug in a concentrated or powder form can be reconstituted in the vial by the addition of a diluent introduced and withdrawn by the syringe. The drug solution in the syringe can then be administered directly to the patient by a needle-through-the-skin injection or indirectly to the patient by a needle-into-a-septum addition to an l.V. fluid administration system.
In other fluid administration situations, sharp plastic piercing pins or dispensing pins can be used to penetrate the stopper of the drug vials. These piercing pins or dispensing pins are traditionally connected via flexible tubing directly to a fluid administration system. The fluid flow from the vial can be either gravity flow or pumped. The flow through the tube can be further controlled by manual clamps or flow control devices.
Recent concern about accidental needle sticks has led to the use of adapters to reduce the need for sharp needle access to vials. Typically the vialadapters use a sharp plastic cannula to penetrate the stopper of the vial. The opposite end of the cannula may include a standard female luer fitment for fluid communication with a syringe barrel having a compatible male luer fitment at its terminal end. In another embodiment, as disclosed in International Application PCT/US90/06071 titled Pre-slit Injection Site, the opposite end of the cannula may include a pre-slit septum compatible with a blunt cannula on a syringe or an l.V. Iine connector for example.
In the no-needle vial access systems and embodiments described 2~32~
above, the vial stopper is pierced by the sharp plastic cannula. Then the vial is inverted so that the vial solution can drain from the vial through the cannula which has penetrated the stopper.
Often, however, a residual amount of drug remains in the vial due to the position of the opening in the penetrating cannula relative to the bottom of the vial stopper. The residual can be as much as 5 to 10% of the solution volume for somevials. In order to fully drain the solution in the vial, the health care provider must manipulate the adapter by partially withdrawing the cannula so that the cannula opening is at the bottom of the inverted vial adjacent the stopper. This manipulation requires additional time or reintroduces the potential for accidental needle stick or contamination of the fluid system by the health care provider. In many instances a residual amount of drug solution is left in the vial due to these concerns. Thus the patient may not receive the proper dosage.
The present invention is directed to an adapter for a drug vial which is configured to maximize the cumulative flow of fluid from a vial to a fluid delivery system with minimal health care provider intervention.
SUMMARY OF THE INVENTION
An adapter for a drug vial embodying the principles of the present invention includes a hollow portion having an opening at a first end, a second open end and a fluid passageway therebetween. The first end has a piercing point and is configured to maximize the cumulative flow of fluid from the inverted vial. The second open end is adapted for connection with various fluid delivery systems.
More specifically, the first end includes an axially extending slot opening into the fluid passageway. The slot extends axially from the opening in the first end to allow drug residual in the inverted vial to fully drain from the viai. The piercing point is a cannula having a sharp end. The open slot can extend from the single opening if the sharp end is beveled or can extend from an offset opening if the sharp end is pointed with a solid center point.
The adapter further includes a shroud member coaxially offset from the hollow portion for surrounding the sharp end of the cannula to protect it during , ~, - , ~ . , ~ .
~ -209 ~32~' manufacture and use.
The adapter further includes fluid access connection at the second open end of the passageway to various fluid delivery systems. These access connections many include a pre-pierced septum for use with a blunt cannula, a female luer connection preferably with a luer or mechanically activated valve for use with a male luer connector, or a simple tube connector for connection to a flexible tube.
Other features and advantages of the present invention will become readily apparent from the following detailed description, the accompanying drawings, and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross-sectional view of an adapter housing according to the present invention;
FIG. 2 is a top view of the vial adapter of FIG. 1;
FIG. 3 is an enlarged perspective view of the sharp plastic cannula of FIG. 1 turned 90 degrees;
FIG. 4 is a side view of an alternate plastic cannula according to the invention;
FIG 4A is a top view of Fig. 4;
FIG. 5 is a side view of another alternate plastic cannula according to the invention;
FIG. 5A is a top view of FIG. 5;
FIG. 6 is a partial cross-sectional view of the vial adapter in use with a standard vial and a blunt cannula fluid delivery system; and FIG. 7 is a view similar to FIG. 6 showing another adapter having a luer fitting to a syringe with a compatible luer fitting and also showing the residual fluid drainage capability of the present invention.
DETAILED DESCRIPTION
While the present invention is susceptible of embodiment in various form, there is shown in the drawings and there will hereinafter be described a presently preferred embodiment, with the understanding that the present disclosure is ' :
.

2~9~329 to be considered as an exemplification of the invention and is not intended to limit the invention to the specific embodiment illustrated.
With reference now to the drawings, there is illustrated in FIG. 6 a unit dose vial 10 including a neck portion 12 closed at its outer end by means of a conventional vial cap assembly including a rubber stopper 14 held in position bymeans of an aluminum retaining ring 16. The stopper 14 includes a thinned central portion 18 which is adapted to be pierced by a hypodermic needle or a piercing pin which can be advanced through a center opening 19 in the retaining ring 16. The center opening is usually closed by an integral but removable portion of the retaining ring 16.
Referring now to FIG. 1, adapter 20 includes an adapter housing 22 having a hollow portion 24 with an opening at a first end 26, a second open end 28 and a fluid passageway 30 therebetween. The adapter housing is preferably injection molded as a single piece of sterilizable plastic such as PCTG plastic which is suitable for medical use.
The first end 26 of the hollow member 24 includes an axially extending cannula 32 having a sharp end 34 for piercing the rubber stopper 14 of the vial. As shown in FIGS. 1 and 3, the sharp end can be a beveled point on the plastic cannula 32. Associated with the opening 36 at the sharp end is an axially extending slot 40 opening into the fluid passageway 30 and which extends from the heel of the beveled sharp end to the penetration point 44 on the cannula 32. The penetration point corresponds to the penetration thickness of the central portion 18 of the stopper. The length of slot 40 extends only to the penetration point so that fluid in the vial cannot leak through the slot to bypass the stopper.
An alternate embodiment of the sharp cannula is shown in FIG. 4 and 4A. The cannula is a generally cylindrical, hollow body 50 which tapers into a solid center point 52. A single opening 54a or alternatively a plurality of openings such a 54 a and 54b as shown in FIG. 4A are provided in the tapered point to allow fluid communication with the center passageway 30. An axially extending slot 56 extends from at least one of the openings to the penetration point so as to maximize the ;:

~;
:
, , , 20~329 drainage from the vial.
Often it is desirable to provide air venting to a vial to assist draining the solution from the vial. As shown in FIG. 5 and 5A, plastic cannula 60 has a generally cylindrical body which tapers into a solid center point 62. At least two lumens, 64 and 66 for example, extend through the cylindrical body and open into the tapered sharp end. An axially extending slot 68 extends from one of the lumens, 64 for example,to the penetration point so as to maximize the drainage of solution from the vial. The other lumen is used for venting air from outside the vial.
As an alternative to the axially extending slot described in the above embodiments, an axial series of radial holes in fluid communication from the outer surface of the cannula 32 to the axially extending fluid passageway 30 could be utilized. The radial holes would be limited in their axial disposition by the thickness of the stopper to be penetrated so as not to cause fluid leakage past the stopper.
As shown in FIG. 1, the adapter may further include an integrally molded radially extending flange 70 and an axially extending shroud member 72 for surrounding the sharp plastic cannula 32. The shroud member is dimensioned to fit loosely over the vial cap assembly. The shroud provides protection from touch contamination of the piercing cannula.
The second open end 28 of the fluid passageway provides connection with a fluid delivery system. For example, in FIG. 7 a tapered female luer connection 80is used for connection with a male luer connector 82 on a syringe. The female luer 80 would be covered by a removable cap to maintain sterility before use. Preferably, a luer or mechanically activated valve (not shown) would be provided in the female luer 80 to maintain sterility prior to use.
In another embodiment of the adapter as shown in FIG. 1, the second open end 28 of the hollow member 24is configured as a tapered tube connector forconnection to flexible l.V. tubing. The connection can be made by solvent bonding or other well known techniques.
In a preferred embodiment of the invention, as shown in FIG. 6, the second open end of the fluid passageway is configured with a pre-pierced resilient ,~

-.

. .

209~323 septum 84 for use with a blunt cannula device 86. An example of a pre-pierced septum is the LifeShieldrM Pre-Pierced Reseal sold by Abbott Laboratories.
In operation, the adapter 20 is sterilely packaged prior to use. The sharp cannula 32 is positioned over the center of the rubber stopper 20 and pressed towards the vial so the sharp end 34 of the cannula pierces the stopper. As shown in FIG. 6, the shroud member 72 generally surrounds the vial top when the cannula penetrates through the stopper thickness. The vial and adapter are then inverted to the position shown in FIG. 6 so that the tluid may drain from the vial by gravity or be withdrawn by a syringe or a pump device.
As best seen in FIG. 7, near the end of the fluid flow from the vial, a small quantity of residual fluid remains in the vial below the level of the opening 36 in the sharp pointed end of the cannula. This residual fluid normally would not drain from the vial without further manipulation by the health care provider. Axially extending slot 40 allows the solution that traditionally would remain in the vial as residual, to drain from the vial without further manipulation by the health care provider. The present invention thus can save time during drug administration procedures for health care providers.
The patient also benefits by receiving the full dose of the solution in the vial, specifically the residual solution in the vial which is often discarded without administration to the patient.
From the foregoing, it will be observed that numerous modifications and variations can be effected without departing from the true spirit and scope of the novel concept of the present invention. It is to be understood that no limitation with respect to the specific embodiment is intended or should be inferred. Disclosure is intended to be covered by the appended claims and all such modifications as fall within the scope of the claims.

:' , .
, , : ~

Claims (11)

1. An adapter for a vial of the type having a pierceable stopper closing an open end of the vial, the adapter to be used for fluid connection with a fluid delivery system, said adapter comprising:
a housing including a hollow portion having an opening at a first end, a second open end and a fluid passageway therebetween;
means at said first end of said hollow portion for piercing the stopper;
means associated with the opening at the first end of said hollow portion for minimizing the fluid remaining in the vial when the vial is inverted for fluid delivery;
and access means at said second open end of said hollow portion for connection with the fluid delivery system.
2. The adapter of claim 1 wherein the flow minimizing means is an axially extending slot opening into the fluid passageway of said hollow portion, said slot extending from said opening in said first end to an axial point on the hollow portion axially sufficient to allow complete penetration of the stopper by the hollow portion.
3. The adapter of claim 2 wherein the piercing means is an axially extending cannula having a sharp end.
4. The adapter of claim 3 wherein the sharp end of the cannula is beveled.
5. The adapter of claim 3 wherein the sharp end of the cannula is pointed, having a solid center point.
6. The adapter of claim 5 wherein the cannula is a dual lumen cannula including a venting passageway axially extending from a second opening at said sharp end.
7. The adapter of claim 3 further including a shroud member coaxially offset from the hollow portion for surrounding the sharp end of the axially extending cannula.
8. The adapter of claim 3 wherein the access means for connection to the fluid delivery system is a pre-pierced resilient septum for use with a blunt cannula.
9. The adapter of claim 3 wherein the access means for connection to the fluid delivery system is a mateable luer connector for use with a compatible luer connector.
10. The adapter of claim 9 further including a valve in the fluid access means activated by the compatible luer connector.
11. The adapter of claim 3 wherein the access means for connection to the fluid delivery system is tube connector for connection to a flexible tube.
CA 2094329 1992-04-23 1993-04-19 Flow adapter for drug vial Abandoned CA2094329A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87257192A 1992-04-23 1992-04-23
US872,571 1992-04-23

Publications (1)

Publication Number Publication Date
CA2094329A1 true CA2094329A1 (en) 1993-10-24

Family

ID=25359869

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2094329 Abandoned CA2094329A1 (en) 1992-04-23 1993-04-19 Flow adapter for drug vial

Country Status (1)

Country Link
CA (1) CA2094329A1 (en)

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Legal Events

Date Code Title Description
EEER Examination request
FZDE Dead