IE43883B1 - Vial and transfer device for intravenous fluids - Google Patents

Abstract

A container (10) comprises several nutrient components separated from one another by plugs (26, 28, 30) and is sealed by a stopper (18). For use, a thin membrane (24) of the stopper (18) is pierced through by the tip of the mandril of a rod-shaped device, all the plugs (26, 28, 30) are pressed out of their seats and the contents of the individual compartments in the container (10) are mixed. Thereafter, the container (10) is placed by means of the rod-shaped device on to a bottle (54) containing solvent, in such a way that the mixed components flow out of the container (10) via channels (36, 38) in the rod-shaped device and into the bottle (54). This facilitates quick preparation and prevention of mistakes when determining the quantities of medical nutrient solutions.

Description

This invention relates to a vial and transfer device for intravenous fluids.

Hyper-alimentation is becoming more common as a form of care for the seriously ill. Typically, a number of different nutrients, vitamins and electrolytes are administered intravenously to the patient. In general, these different ingredients are supplied or formulated in the form of a concentrate which is diluted with an ordinary intravenous solution at the time of administration. In LO many cases, the nutrient, vitamin and electrolyte concentrates are added to the intravenous solution in fixed ratios or percentages. However, many of these concentrates are not storage stable when admixed, that is, they are incompatible or reactive when combined and held over L5 a prolonged period. Consequently, they cannot be premixed, and sold and held in that form. The problem has arisen with the preparation of these mixtures in hospitals. Many alimentation solutions are used every day, and considerable time is spent in decanting and measuring the proper ’0 amounts of the various components and adding them to intravenous solutions. This procedure is also fraught with opportunities for error, mix-up and loss of sterility. The present invention overcomes these problems by providing a completely closed system in which two, three, four or !5 even more different components for alimentation can be packaged in proper concentration and ratios in a factory under rigid aseptic conditions, yet held in physical separation from each other to provide long-term storage 43383 stability and life, and yet are quickly and easily admixed at the time of use without opening the system to the risk of contamination.

According to the invention, there is provided a vial and transfer device for use in alimentation, wherein the vial comprises a rigid generally cylindrical fluid container having an open and a closed end, an: imperforate stopper in the open end, at least one annular radially inwardly projecting ring within the container formed integrally with the wall of the container and a tippable sept'jn abutting the or each respective ring, the septum or septums dividing the interior of the container into separate chambers for substances to be mixed and the fluid transfer device comprising an elongate passage section having two parallel fluid passages extending therethrough, the passage section being extended through a flange which extends in a plane generally perpendicular to the direction of extent of said passages for limiting penetration of the transfer device through the stopper into the container during use thereof, one end of the passage section having a cutting edge, the other end of the passage section being joined to an elongated solid rigid spike terminating in a point at its end remote from the passage section, a lateral fluid opening in proximity to the point of jointure of the spike to said other end of the passage section communicating with the passages, at least one lateral hole in one of said passages and, on the opposite side of the flange, at least one lateral hole in the other of said passages, the lateral holes on opposite sides of said flange functioning to prevent a fluid slug from restricting the rate of fluid through the passages, and the point of the spike being adapted to puncture the stopper and tip each septum when inserted into the container whereby the contents of the - 4 different chambers can be mixed without contamination from the exterior and the fluid contents can flow into said opening and through the passage section for the removal of the contents of the fluid container after mixing.

With this arrangement a plurality of different alimentary components which are not compatible in longterm storage can be packaged in a single device under aseptic condition, be maintained separate by physical, barriers and yet be rapidly combined just prior to use.

The invention will be further described, by way of example, with reference to the accompanying drawings, wherein: Figure 1 is a longitudinal section Of one embodiment of the rigid cylindrical fluid container or vial of this invention.

Figure 2 is an end view of the fluid transfer device and spike of the device of this invention.

Figure 3 is a section taken along the lines 3-3 in Figure 2.

Figure 4 is a perspective view of the fluid transfer device and spike of this invention'.

Figure 5 is a section view showing the spike piercing the end stopper and tipping two of the three septa.

Figure 6 shows the subsequent state of the device in sectional view wherein the spike has tipped all three septa to permit mixing the contents of all four chambers.

Figure 7 is a section view of the last phase in the use of this invention wherein the admixed contents of the fluid container are transferred to a standard bottie of intravenous solution for dilution.

Referring to the drawings, a rigid cylindrical fluid container 10, which is made of a medically compatible material such as glass, has a plurality of integral radially 43883 inwardly projecting annular rings 12, 14 and 16 formed in its wall. An imperforate end stopper 18 closes the open end of fluid container 10. The stopper 18 preferably, as shown, has a shoulder 20 the underside of which abuts the end of the fluid container 10 and prevents the further advancement of stopper 18 into the fluid container under forces applied thereto in use as further discussed hereinbelow. The stopper 18 has an off-set hole 22 which is bridged by a thin diaphragm 24. Abutting the annular rings 12, 14 and 16 are septa 26, 28 and 30, respectively. Preferably, the septa are provided with sealing rings 32. The septa and end stopper are normally made of a compatible resilient material, usually rubber. The septa can be flat or centrally domed which can improve the operation of the device at the time the septa are upset in use as later described.

While the drawings depict a four compartment device, it will be understood that this invention is applicable to two, three, four or more compartment devices.

A fluid transfer device 34 is shown in Figures 2 to 4 as having two parallel fluid passages 36 and 38 which extend through a passage section of the device which itself extends through a flange 40. The one end of the passage section has a cutting edge 42. The other end of the passage section is joined to an elongated solid rigid spike 44 which terminates at a point and is long enough to reach and upset the septa when inserted into the container 10. A fluid opening 48 is provided in proximity to the point of joindure of the spike to the passage section and in communication with the passages 36 and 38 to permit the flow of fluid through passages 36 and 38.

Preferably, the entire unit shown in Figure 4 is 43383 - 6 aseptically packaged in a disposable paper or plastics bag. At the time of use, the packaging is removed and the spike forced through the diaphragm 24 of the container until the flange 40 comes into abutment with the outside surface of end stopper 18 which limits the depth of penetration of the spike into the container as shown in Figure 6, all of the septa being upset in the process. A protective cap 50 is then removed to expose the cutting edge 42 which is brought to bear on the rubber stopper 52 of an intravenous solution bottle 54 and pushed therethrough. The admixed contents of fluid container 10 are thus transferred to the intravenous solution bottle 54 for dilution. Instead of the bottle 54 a flaccid bag may be used to contain the solution.

It has been found that improved fluid transfer rate to the intravenous solution bottle is provided by pressure relieving lateral holes or openings 56 into the passage 38 which prevent a fluid slug from forming and restricting or shutting off the transfer process. Additional lateral openings are provided into the other passage 36 on the opposite side of the flange 40 further to assist in preventing slug formation. The lateral openings on opposite sides of the flange are preferably substantially equidistant from the flange. As shown two lateral holes are provided on each side of the flange.

One or more compartments may contain a powdered or lyophilized medicament or alimentary component which may be mixed with a diluent or another alimentary component in the manner described.

Claims (7)

1. CLAIMS;1. A vial and transfer device for use in alimentation, wherein the vial comprises a rigid generally cylindrical fluid container having an open end and a closed end, an imperforate stopper in the open end, at least one annular radially inwardly projecting ring within the container formed integrally with the wall of the container and a tippable septum abutting the or each respective ring, the septum or septums dividing the interior of the container into separate chambers for substances to be mixed and the fluid transfer device comprises an elongate passage section having two parallel fluid passages extending therethrough, the passage section being extended through a flange which extends in a plane generally perpendicular to the direction of extent of said passages for limiting penetration of the transfer device through the stopper into the container during use thereof, one end of the passage section having a cutting edge, the other end of the passage section being joined to an elongated solid rigid spike terminating in a point at its end remote from the passage section, a lateral fluid opening in proximity to the point of joindure of the spike to said other end of the passage section communicating with the passages, at least one lateral hole in one of said passages and, on the opposite side of the flange, at least one lateral hole in the other of said passages, the lateral holes in opposite sides of said flange functioning to prevent a fluid slug from restricting the rate of fluid flow through the passages and the point of the spike being adapted to puncture the stopper and tip each septum when inserted into the container whereby the contents of the different chambers can be mixed without contamination from the exterior and the fluid contents can flow into said opening and through the passage section for the removal of 438S3 the contents of the fluid container after mixing.

2. A vial and transfer device according to claim 1, wherein the fluid container is of glass.

3. A vial and transfer device according to claim 1 5 or 2, wherein the lateral holes on opposite sides of the flange are substantially equidistant from the flange.

4. A vial and transfer device according to claim 1, 2 or 3, wherein there are two lateral holes on each side of the flange. 10

5. A vial and transfer device according to any preceding claim, wherein said container has one, two or three rings and septa to provide two, three or four compart ments respectively.

6. A vial and transfer device constructed and 15 arranged substantially as herein described with reference to and as illustrated in the accompanying drawings.

7. A vial and transfer device according to any preceding claim, in combination with a container of intravenous solution having a rubber closure adapted to be 20 penetrated by said cutting edge.