EP0499764A1

EP0499764A1 - Device for the transfer of liquids between flexible containers and vials

Info

Publication number: EP0499764A1
Application number: EP19910500093
Authority: EP
Inventors: Francisco Faraco Munoz; Gregorio Frias Garcia; Miguel Angel Moreno De La Guerra; Carlos Manuel Sandoval Balcazar
Original assignee: INSTITUTO DE BIOLOGIA Y SUEROTERAPIA SA
Current assignee: INSTITUTO DE BIOLOGIA Y SUEROTERAPIA SA
Priority date: 1991-02-22
Filing date: 1991-08-08
Publication date: 1992-08-26
Also published as: ES1016828U; ES1016828Y; FI912923A; FI912923A0

Abstract

A device is described for transferring liquids between flexible containers and vials, comprising a canule partially surrounded by a plastic piece and protruding laterally toward the inside of a thickening intended for engaging to a vial, sliding at the other end inside a piece which protects said protruding part of the needle and at its free end applied to a flexible container.

Description

The present invention, as stated in the title of this Specification, comprises a plastic device manufactured by injection, provided with a canule sharpened at both ends, adapted to be connected at one end to the appropriate access piece of a flexible container and, at the other end, to the top of a vial containing a liquid or powder which, by piercing of both containers with the canule, allows the transfer of liquids from the flexible container to the vial and from the latter to the flexible container, once its content is dissolved or diluted in the transferred solution, without the need to disconnect the initial connection at any moment of the process.
The device is characterized in being manufactured from such materials capable of being chemically or thermically sterilized, being apirogens and compatible with the solutions with which they are brought into contact.
The device can be manufactured with various shapes at the ends, in accordance with the kind of vial and flexible container to which it is going to be engaged. For example, as illustrative and in no way limitative, vials with a 13 mm, 22 mm or 32 mm diameter mouth, flexible containers with 50 ml, 100 ml, 250 ml, 500 ml, 1,000 ml, 21, 31 capacity with threaded coupling which can have different pitches or be engaged under pressure.
The essential feature of the device is that it is comprised of a stainless steel canule, firmly held to an injected plastic piece, bell-shaped at one end, with suitable dimensions for attaching to the vial mouth, and of another piece of injected plastic, in which the preceding piece internally slides and integral with the canule, so that in the most extended position the ends of the canule do not protrude beyond the ends of the device and, once slid, pierce the flexible container; this piece has at one end the shape of a chamber with appropriate design to be attached to the coupling of the flexible container.
An illustrative embodiment is next described in more detail and by no way limitative, of the object of the invention, making reference to the accompanying drawings, wherein:

Figures 1, 2 and 3 respectively represent an axial lengthwise section, a side and front views of the canule and of the injected plastic piece integral with it.
Figures 4, 5 and 6 respectively represent an axial lengthwise section, a side and front views of the injected plastic piece, inside which the piece integral with the canule slides.
Figure 7 represents an axial lengthwise section of the assemblied arrangement of the canule and the two injected pieces.
Figure 8 represents a side view of the arrangement in its most extended position, with the canule retracted and concealed.
Figure 9 represents a side view of the arrangement, engaged with the flexible container and with the piece integral with the canule, slid to its less extended position, to pierce the container with the canule.

As can particularly be seen in Figure 1, the canule 1 has the shape of a hollow cylinder, with both ends sharpened, and of a suitable length to be able to remain concealed until the time of use, which can be seen in Figure 7.
In the same Figure 1, it is seen that the injected piece is bell-shaped 2 at one end, with an inner diameter slightly larger than the outer diameter of the capsule of the vial with which it is engaged, and of a suitable length, so that on pressing the vial down to the bottom of the bell the canule pierces the cap of the vial and penetrates into the vial sufficiently to issue out of the interior of the cap.
To prevent ready release of the vial from the device, the bell has at one end some bulges 3 directed toward the inside to clamp the top of the vial; these bulges likewise hinder insertion of the top of the vial into the bell, whereby said bell has several openings 4, distributed symmetrically in order to facilitate insertion of the top of the vial.
Next to the bell it is seen that the injected piece clamps the canule, along most of its length, with a non-cylindrical section shape 5, whose purpose is to strengthen the canule, preventing it from folding on piercing and, thanks to its shape, engaging with the piece represented in Figures 4 and 6, allowing lengthwise sliding, but not the rotation of one piece with respect to the other. At the opposite end of the bell 2, the piece again has a cylindrical shape 6, of greater diameter than the non-cylindrical one 5, this increase having as its purpose to avoid separation of the two pieces once assembled; to facilitate mounting, this cylindrical zone is discontinued with hollow zones 7 by way of longitudinal grooves as can be seen in Figure 3.
As can be seen particularly in Figure 4, the injected piece, which will serve as guide and protection for the canule, has a zone of internal circular section shape 8, of appropriate length for concealing the canule in the most extended position of the device, as can be seen in Figure 8, and to produce the piercing of the flexible container in the most retracted position of the device, as can be seen in Figure 9; externally it has a grooved shape 9, in order to facilitate handling of the device, preventing slipping on being grasped with the fingers.
At one end the piece has internally modified its section, adopting a non-cylindrical section shape 10 like the non-cylindrical section zone 5, with a small clearance to facilitate lengthwise sliding of the pieces; this zone having the narrowing with respect to the circular section zone 8 allows, along with zone 6, avoidance of separation of the two pieces once assembled.
At the other end the piece comprises a chamber 11, which can have male screw fillets 12 of luer, luer lock, record type or any other suitable kind of screw pitch or shape for attaching to the supplementary coupling of the flexible container.
Once the cap of the vial is pierced with the canule 1, and the vial attached in the bell 2, the device is engaged to the flexible container by pressure screwing or equivalent action, in accordance with the kind of coupling 12 involved. This engagement is facilitated through the non-cylindrical section zones 5 and 10 which force the pieces and the canule to turn together. By pushing, exercised between the vial, or on the outer part of the bell 2, the piece joined to the canule slides internally to the piece engaged to the flexible container, until piercing said container, along the suitable lengths of this piece and of the canule.
Although one embodiment of the invention has been described and represented, it is evident that modifications can be introduced into it, comprised within the scope of same, and it should not be considered limited to said embodiment, but solely to the content of the following:

Claims

Device for the transfer of liquids between flexible containers and vials, characterized in that it is comprised by a stainless steel canule (1) joined to a plastic piece partially surrounding it and protruding on one side to the interior of a bell-shaped thickening adapted to engage to a vial, sliding at the other end, where the piece of a needle protrudes, inside a piece which protects said protruding part of the needle, and which is applied at its free end to a flexible container.
Device according to claim 1, characterized in that the stainless steel canule (1) has both ends tapered and sharpened a suitable length so that, in the most extended position of the device, the canule (1) will not protrude therefrom and, in the most rectracted position, protrude from the protection piece, a sufficient length to pierce the flexible container.
Device according to claim 1, characterized in that the bell-shaped thickening (2) of the plastic piece integral with the canule is of dimensions adapted to the top of the vial to which it is desired to transfer the liquid and is then provided with some bulges (3) directed inwardly, adjacent to the free edge of the bell, to avoid separation of the vial, and axial openings (4) beginning on said free edge, facilitating insertion of the top of the vial, and in that the outer area of said bell (2) surrounding integrally the canule (1) has a non-cylindrical smaller transversal cross-section (5), whose opposite end has a thickening to serve as stop to a corresponding thickening of the end of the protection piece and to avoid separation of the same, said thickening having a cylindrical profile (6) provided with wide grooves parallel to the axis of the canule (1), to facilitate engagement to the two plastic pieces.
Device according to claim 1, characterized in that the protection piece of the canule (1), which also serves as guide for the piece integral with the canule, has a cylindrical transversal cross-section (8) bore with a diameter slightly larger than that of the broadened end of the canule piece, to allow lengthwise sliding of one piece with respect to the other, while the narrowing of the inner end of the same has a non-circular transversal cross-section, conjugated from the transversal section of the part surrounding the canule, with sufficient space to allow mutual sliding lengthwise, but not to turn, and likewise avoiding the separation of both pieces.
Device according to claim 4, characterized in that the protection piece of the canule (1) has its outer surface grooved (9) in axial direction to improve manual attachment of the same.
Device according to claim 4, characterized in that the outer or free end of the protection piece has a thickening provided inside with a screw or other type of suitable attachment to engage the device to the flexible container.