EP1034772B1 - Device for transfering a substance contained in a vial to a pouch containing a solute - Google Patents

Abstract

A connector made from an injection-mouldable and sterilisable plastic, comprising a first basically cylindrical guide (2), open at one end (6) and closed at the other (5), and a second guide (14) extending coaxially from the closed end of the first guide, and having an open end for the inlet (15) of a solute pouch (16), is new. A connector made from an injection-mouldable and sterilisable plastic, comprising a first basically cylindrical guide (2), open at one end (6) and closed at the other (5), and a second guide (14) extending coaxially from the closed end of the first guide, and having an open end for the inlet (15) of a solute pouch (16), is new. A hollow needle (17) for piercing the flask and pouch caps simultaneously is located coaxially inside the connector and passes through the closed end. The first guide (2) is shaped so that it receives not only the neck but the body end of the flask as well, and has a retainer with elastic lugs (7) that allow the flask to slide inside it and hold it in place.

Description

The invention relates to a device for transferring a substance, for example a medicine, into a pocket.

Hospital-based care frequently requires a drug in liquid or solid form, contained in a vial, in a bag of solute.

The contents of the solute bag, e.g. glucose to which the drug is added, is then administered to the patient in a continuous manner, for example using a conventional infusion device.

There is thus known a transfer device comprising a first part, intended to be mounted on the inlet port of a bag, and a second part, intended to receive the end of a bottle.

The first and second parts are provided with a coaxial hollow needle allowing one hand to pierce the cap of the bottle, generally made of rubber, as well as the inlet port of the bag, then to transfer the contents of the bottle into the pocket on the other hand.

To perform such a transfer, the first part of the device is mounted on the inlet port of the solute bag by piercing the inlet port of the bag, the needle is found in the airlock of the injection site then the vial is mounted on the second part of the device, the needle also piercing the rubber stopper of the vial.

When the bottle and the bag are thus mounted on the device, the inside of the bottle and the inside of the bag are in communication.

By compressing and then releasing the solute bag, a depression is established, allowing the drug to pass from the vial to the solute bag.

Once the drug is transferred, the vial and the transfer device are generally removed from the bag.

The solute bag containing the drug can then be administered to the patient.

This system however has disadvantages.

Both in terms of safety for the patient and in terms of practice for hospital caregivers.

In terms of safety, there is indeed no means of control, after the transfer made and the transfer device removed from the pocket, that it actually contains the transferred drug on the one hand, and that it is indeed the prescribed medication on the other hand.

In addition, drug transfers can be made to the patient's bed, and hospital staff must assemble on-site bags of solute, transfer devices and vials.

This results in possible errors in the handling of devices, as well as the need to convey throughout the day, all the elements necessary for care.

As a result, there is also a loss of time for hospital care staff when preparing drug transfers.

Document FR-2 473 017 discloses an apparatus for mixing and dispensing two substances under sterile conditions. However, such an apparatus has the particular disadvantage of ensuring insufficient stability of the bottle when associated on the bottle.

The invention aims to remedy these drawbacks, by proposing a transfer device that makes it possible to control the nature of the product transferred and the successful completion of this transfer.

And that also makes it possible to operate the transfer of drugs to the central pharmacy of the hospital, the nursing staff no longer having to bed the patient, to operate the administration of the drug, without having to assemble the various elements between them, and this in complete safety.

For this purpose, the device for transferring, in a solute bag, a substance, for example a medicinal substance, contained in a receptacle, such as a vial, comprises a first guide, of generally cylindrical general shape, open to the patient. one of its ends and closed at its other end opposite the open end.

The first guide is adapted to receive at least the neck and the upper part of the body of the bottle, the bottle being capable of sliding at least partially in the first guide.

The first guide further comprises means adapted to prevent the total withdrawal of the bottle from the first guide after its introduction therein, said means being arranged so as to allow at least partial sliding of said bottle in the first guide.

The device according to the invention further comprises a second guide, of substantially cylindrical general shape, extending the first guide side of the closed end thereof and mounted coaxially with the first guide.

The end of the second guide opposite the first guide is open and adapted to receive the inlet of the solute bag.

The device according to the invention also comprises a means for piercing the means for closing the bottle and the solute bag, respectively, and for transferring the substance contained in the bottle into the solute bag, the piercing means being arranged coaxial with the first and second guides.

According to the invention the first guide is able to receive not only the neck but also the upper part of the body of the bottle, and the means able to prevent the total withdrawal of the bottle are elastic and are arranged on the inner face of the first guide so to allow at least partial sliding of said bottle in the first guide.

According to other features and a particular embodiment of the invention, the means preventing the withdrawal of the bottle comprise at least one elastic tab formed on the inner face of the first guide, for example at the open end of the first guide.

The tab projects from one of its ends towards the interior of the first guide being directed towards the closed end of the first guide.

For example, the inner face of the first guide may comprise three elastic tabs arranged substantially uniformly with each other and substantially at the same level on the inner face of the first guide.

According to another embodiment, the means preventing the removal of the bottle comprise at least one elastic annular lip disposed on the inner face of the first guide, for example at the open end of the first guide.

The annular lip is disposed projecting inwardly of the first guide, substantially perpendicular to the longitudinal axis of the first guide.

According to the invention, the second guide can be fixed rigidly on the first guide.

Alternatively, the second guide is slidably mounted on the first guide.

According to this second variant, the second guide comprises a region of smaller external diameter, located towards the end of the second guide opposite to the open end of the second guide and intended to slide in an opening of corresponding diameter formed in the end closed of the first guide.

The end portion of the smaller diameter region located on the side of the first guide is provided with an annular lip forming a bearing surface against the closed end of the first guide, inside thereof, so as to block the sliding of the second guide in the first guide.

The piercing means of the closure means of the bottle and the inlet port of the bag comprise a hollow needle along its entire length, coaxial with the first and second guides.

The two ends of the needle are shaped beveled tips, opening for one in the first guide and the other in the second guide.

In the alternative embodiment in which the second guide is fixedly mounted, the needle is held in place at the closed end of the first guide.

In the alternative embodiment in which the second guide is slidably mounted, the needle is held in place at the region of smaller diameter of the second guide.

According to one embodiment of the invention, the tip of the needle opening into the first guide and / or the tip of the needle opening into the second guide is protected by a flexible envelope, for example latex.

The transfer device according to the invention may be independent of the solute bag and the bottle, the various elements being assembled before the transfer.

In this variant, the second guide may comprise means able to prevent the total withdrawal of the inlet orifice of the solute bag from the second guide after it has been inserted into it. For example, said means have a structure identical to those arranged in the first guide and are arranged to allow at least partial sliding of the inlet port in the second guide.

Alternatively, the transfer device according to the invention can be integrated, permanently and not detachable, to a solute bag.

For example, the transfer device of the invention may be fixedly mounted on the inlet port of a solute bag, at the open end of the second guide.

In this case, the user only has to introduce the bottle in the first guide, before proceeding with the transfer.

According to this variant, the tip of the needle on the side of the solute bag does not need to be protected by a flexible envelope, since it is no longer in contact with the outside.

Similarly, the tip of the needle on the side of the solute bag does not need to be beveled, since it no longer pierces the inlet port of the solute bag.

According to this variant, the transfer device mounted on the solute bag can be protected, in addition to the flexible envelope covering the needle on the side of the first guide, by a lid resting on the longitudinal walls of the first guide.

• La figure 1 représente une vue schématique, en coupe longitudinale, d'un mode de réalisation du dispositif de transfert de l'invention.
• La figure 2 représente une vue schématique, en coupe longitudinale, d'un autre mode de réalisation du dispositif de transfert de l'invention.
• Les figures 3, 4, 5 et 6 représentent des vues schématiques, en coupes longitudinales, du fonctionnement du dispositif de transfert représenté sur la figure 2.

The invention will be better understood in the description which follows, made with reference to the appended figures.

• Figure 1 shows a schematic view, in longitudinal section, of an embodiment of the transfer device of the invention.
• FIG. 2 represents a schematic view, in longitudinal section, of another embodiment of the transfer device of the invention.
• Figures 3, 4, 5 and 6 show schematic views, in longitudinal sections, of the operation of the transfer device shown in Figure 2.

Referring now to Figure 1, the transfer device 1 according to the invention comprises a first guide 2 adapted to receive, at least partially, a bottle 3.

The first guide 2 is of generally cylindrical shape, the shape of the first guide depending on that of the bottle.

Thus, the first guide may be of a shape other than cylindrical, for example parallelepiped, to fit bottles of a corresponding shape.

The first guide 2 comprises a longitudinal wall 4 open at one of its ends 6 and closed at its opposite end 5.

At its open end 6, the first guide 2 is provided with means preventing the withdrawal of the bottle 3 from the first guide 2. These means also allow at least partial sliding of the bottle 3 in the first guide 2.

According to the embodiment shown in FIG. 1, the means preventing the withdrawal comprise two elastic tabs 7 arranged on the internal face 8 of the longitudinal wall 4 of the first guide 2.

The two tabs 7 are arranged to allow the introduction of the bottle 3 into the first guide 2 and prevent its total withdrawal from it while allowing the sliding of said bottle 3 in the first guide 2.

According to the embodiment shown, the tabs 7 deviate towards the inner face 8 of the first guide 2 under the action exerted by the neck 9 of the bottle 3.

The neck 9 of the bottle 3 can then be introduced into the first guide 2.

After the passage of the neck 9, the tabs 7 return to their initial position, the bottle 3 being partially introduced into the first guide 2, the neck 10 of the bottle 3 being at the level of the tabs 7.

Under the action of an additional force, the lugs 7 can then again deviate towards the inner face 8 of the first guide 2, to allow said vial to slide so as to effect the passage of the body 11 of the vial 3.

The tabs 7 are fixed to the inner face 8 of the first guide 2 by one of their ends 12, the other free end 13 of the tabs 7 being directed towards the closed end of the first guide 2, so as to block the withdrawal of the bottle 3 out of the first guide 2, at the neck 10 of the bottle 3.

The number of tabs 7 may vary depending in particular on the shrink resistance that it is desired to confer on the transfer device 1 of the invention.

According to one embodiment, the transfer device 1 comprises three tabs 7 arranged substantially at the same level of the inner face 8 of the first guide 2 and spaced substantially evenly between them.

The first guide 2 is extended towards the closed end 5 by a second guide 14.

According to the embodiment shown in FIG. 1, the second guide 14 is fixedly arranged and coaxial, with respect to the median longitudinal axis X of the device 1, with the first guide 2.

The second guide 14 is hollow and intended to receive the inlet 15 of a solute bag 16.

In the embodiments shown in the figures, the inlet orifice 15 comprises a bushing 28 made of elastomer that can be traversed by the U-shaped needle 17 and autorecleant and which is closed by a cover 23. introduction of the needle 17 into the inlet orifice, which first passes through the lid 23 to be in the lock chamber 29 formed inside the U and an additional sliding brings the needle 17 into position. contact with the bottom 30 of the U so that it can pass through and thus bring the interior of the solute bag into contact with the outside.

In a variant, the second guide comprises means preventing the total withdrawal of the inlet orifice 15 from the second guide 14 after its insertion therein.

According to one embodiment shown in the figures, the means preventing the total withdrawal have a structure identical to that of the means preventing the withdrawal of the bottle 3 and therefore comprise two elastic tabs disposed on the inner face of the longitudinal wall of the second guide 14.

When introducing the inlet port 15, the tabs 25 deviate towards the inner face of the second guide 14 under the action exerted. The locking of the withdrawal of the inlet orifice 15 is then made between the free end 26 of the tabs 25 and a circular flattened portion 27 formed on said orifice. The assembly formed by the solute bag 16 and the device 1 is then in a first position (see FIG. 2) in which, although associated with each other, the needle 17 has not passed through the 23. Under the action of an additional force, the inlet orifice 15 can then slide so that the needle is in the chamber 29 (second position shown in particular in Figure 1) and then crosses the bottom 30 to bring the interior of the solute bag 16 into contact with the inside of the bottle 3 (third position shown in particular in FIG. 6).

The second guide 14 comprises a hollow needle 17, substantially parallel to the median longitudinal axis X.

The needle 17 is provided with two ends forming beveled tips 18 for piercing the inlet 15 of the solute bag 16 on the one hand and the bottle cap 3 on the other hand.

The needle 17 is held in place at the closed end 5 of the first guide 2, the two tips 18 of the needle 17 opening for one in the first guide 2 and for the other in the second guide 14 .

A base region 19 may be provided on the closed end 5 side of the first guide 2 (or, alternatively, on the side of the second guide 14) to reinforce the rigidity of the needle 17.

In particular, the base region 19 makes it possible to prevent the needle 17 from twisting when piercing the cap of the vial 3 or of the inlet 15 of the solute bag 16.

The transfer device 1 may be made of an injectable plastic material.

The plastic used must also be able to withstand the conditions of sterilization.

For example, the transfer device may be made of a polymer based on polyethylene, polycarbonate, polypropylene, polystyrene, and the derivatives and / or mixtures of these products.

The transfer device shown in FIG. 1 is made by injection from the raw materials indicated above, the first and second guides being formed in one piece and the over-molded needle.

Another embodiment of the transfer device 1 is shown in FIG.

In FIG. 2, the same reference numerals correspond to the same elements as those described with reference to FIG. 1 and will therefore not be repeated in detail in the following.

Referring now to the embodiment shown in FIG. 2, the transfer device 1 comprises a first guide 2 and a second guide 14 into which the tips 18 of a needle 17 open.

According to this embodiment, the second guide 14 is slidably mounted on the first guide 2.

This is to facilitate the assembly and transfer of a drug contained in a bottle.

To do this, the second guide 14 comprises a region of smaller outer diameter 20, located at the end of the second guide 14 located on the side of the first guide 2.

This region of smaller outer diameter 20 is slidably mounted in a corresponding opening formed on the closed end 5 of the first guide 2.

A more or less easy sliding of the second guide 14 can be obtained depending on the choice of plastic materials used for the first and second guides and the outer diameter of the region 20 relative to the opening on the closed end 5 of the first guide 2.

Sliding can be further facilitated by the deposition of a silicone material on the region of smaller outer diameter 20.

The sliding of the second guide 14 is limited in one direction by an annular lip 21 forming a bearing surface against the closed end 5 of the first guide 2, inside the first guide 2.

The sliding of the second guide 14 is limited in the other direction by the return of the second guide 14 to its normal diameter, at the region 22.

The embodiment of the transfer device 1 according to the invention as illustrated in Figure 2 involves the separate manufacture of two parts corresponding to the first and second guides.

Figures 3, 4, 5 and 6 illustrate the operation of the transfer device according to the invention.

In FIGS. 3 to 6, the same reference numerals designate the same elements as in FIGS. 1 and 2.

Referring now to these figures, a transfer device 1 according to the invention is mounted, via the second guide 14, on the inlet 15 of a solute bag 16 so as to make the device 1 and the solute bag 16.

Under the action on additional force exerted in the direction X, the tip 18 of the needle 17 located on the side of the second guide 14 pierces the lid 23 closing the inlet 15 of the pocket 16 so that the tip 18 is arranged in the airlock 29 (Figure 3).

The other point 18 of the needle 17 located on the side of the first guide 2 is protected by a flexible envelope that is self-climbing 24, for example made of latex, in order to guarantee the sterility of the transfer device 1.

Such an envelope 24 may also be provided on the side of the tip 18 of the needle 17 located on the side of the second guide 14.

After placing the transfer device 1 on the solute bag 16, a bottle 3 containing for example a drug is introduced into the first guide 2 (Figures 4 and 5).

Under the action of a force exerted on the bottle 3 in the direction X, the elastic tabs 7 deviate against the inner face 8 of the first guide 2 to allow the passage of the neck 9 of the bottle 3, then return to their position initially during the passage of the neck 9 of the bottle 3 (Figure 4).

In this configuration, the bottle 3 is associated with the solute bag 16 via the transfer device 1 to form a unitary assembly in which the inside of the bottle 3 and the inside of the bag 16 are not in communication . In particular, the solute bag 16, the device 1 and the bottle 3 are associated with each other irreversibly.

By unitary unit, it is understood that it can be stored, sold, manipulated and used together.

Under the action of a second force exerted on the bottle 3 in the direction X, the tabs 7 can again deviate to allow the sliding of the bottle 3 and thus the passage of the body 11 of the bottle 3 (Figure 5).

The cap of the bottle 3 then comes into contact with the tip 18 of the needle 17 protected by the envelope 24.

The operator can then exert a force on the solute bag 16 and on the bottle 3 so as simultaneously to cause on the one hand an additional sliding of the bottle 3 which leads to the piercing of the cap and the envelope 24 by the needle 17 and on the other hand an additional sliding of the inlet 15 which leads to the drilling of the bottom 30 by the other end 18 of the needle 17. This action communicates the interior of the bottle 3 with the interior of the solute bag 16, through the hollow needle 17 (Figure 6).

The solute bag 16 is positioned with the inlet port 15 directed downwards to introduce, by exerting manual pressure on the solute bag 16, a small amount of solute inside the bottle 3 to dissolve the medicine it contains. After dissolution, the whole bag of solute 16 and bottle 3 is turned over in order to transfer the contents of the bottle 3 into the solute bag 16, the sterile air of the solute bag 16 replacing the liquid contained in the bottle 3.

Once the transfer is complete, the bottle 3 remains on the device 1 according to the invention, its removal being prevented by the tabs 7 which block the passage of the neck 9 out of the first guide 2.

Claims (24)

1. Device (1) for transferring into a solution pouch a substance, for example a medical substance, contained in a flask (3) comprising a body (11), a neck (10) and a mouth (9), said device comprising:

   - a first guide (2), of a substantially cylindrical general shape, open on one end (6) and closed at the other end (5) opposite the open end (6), said first guide (2) being arranged to receive not only the neck (10) but also the upper part of the body of the flask (3);

   - a second guide (14), of a substantially cylindrical general shape, extending from the first guide (2) on the closed end (5) thereof and mounted coaxially with the first guide (2), the end of the second guide (14) opposite the first guide (2) being open and capable of receiving the entry orifice (15) of the solution pouch (16);

   - a means of piercing the means of closing the flask (3) and the solution pouch respectively, and of transferring the substance contained in the flask to the solution pouch (16), the piercing means being placed coaxially with the first (2) and second (14) guides ;

   - the inner face (8) of the first guide (2) comprising elastic means arranged so as to allow the at least partial sliding of the flask within the first guide (2), characterised in that

   said elastic means are in contact not only with the neck (10) but also with the upper part of the body (11) of the flask (3) and are capable of impeding the complete removal of the flask (3) from the first guide (2) after its insertion therein.
2. Device according to claim 1, characterised in that the means impeding the removal of the flask (3) comprise at least one elastic tab (7) arranged on the inner face (8) of the first guide (2), for example at the level of the open end (6) of the first guide (2), the tab (7) projecting towards the inside of the first guide (2) by one of its ends (13) being directed towards the closed end (5) of the first guide (2).
3. Device according to claim 2, characterised in that the tabs (7) are affixed to the inner face (8) of the first guide (2) by one of their ends (12), the other end (13) of the tabs (7) being directed towards the closed end (5) of the first guide (2).
4. Device according to claim 2 or 3, characterised in that it comprises three elastic tabs (7) evenly spaced and substantially at the same level on the inner face (8) of the first guide (2).
5. Device according to claim 1, characterised in that the means impeding the removal of the flask (3) comprise at least one elastic annular lip arranged on the inner face (8) of the first guide (2), for example at the level of the open end (6) of the first guide (2), projecting towards the inside of the first guide (2), substantially perpendicular to the longitudinal axis (X) of the first guide (2).
6. Device according to any one of the claims from 1 to 5, characterised in that the second guide (14) is rigidly fixed on the first guide (2).
7. Device according to any one of the claims from 1 to 5, characterised in that the second guide (14) is mounted such as to slide on the first guide (2).
8. Device according to claim 7, characterised in that the second guide comprises a region with a smaller outer diameter (20), situated towards the end of the second guide (14) opposite the open end of the second guide (14) and intended to slide into an opening of matching diameter made in the closed end (5) of the first guide (2).
9. Device according to claim 8, characterised in that the end part of the region with a smaller diameter (20) situated on the side of the first guide (2) is equipped with an annular lip (21) forming a bearing surface against the closed end (5) of the first guide (2), on the inside thereof, such as to block the sliding of the second guide (14) in the first guide (2).
10. Device according to claim 8 or 9, characterised in that the region with a smaller diameter (20) is coated in a material treated with silicone.
11. Device according to any of the claims from 1 to 10, characterised in that the means of piercing the means of closing the flask (3) and the entry orifice (15) of the pouch (16) comprise a needle (17), hollow for its entire length, coaxial with the first (2) and second (14) guides, the two ends of the needle (17) being in the form of bevelled points (18), one end opening into the first guide (2), the other opening into the second guide (14).
12. Device according to claim 11, characterised in that the needle (17) is held in place at the closed end (5) of the first guide (2).
13. Device according to claim 12, characterised in that it comprises a region forming a base (19) on the side of the closed end (5) of the first guide (2) or, alternatively, on the side of the second guide (14), in order to reinforce the rigidity of the needle (17).
14. Device according to claim 11 when it depends on claims 8 to 10, characterised in that the needle (17) is kept in place at the level of the region of the second guide (14) with the smallest diameter (20).
15. Device according to any of the claims from 11 to 14, characterised in that the point (18) of the needle (17) opening into the first guide (2) is protected by a flexible cover (24), for example made out of latex.
16. Device according to any of the claims from 11 to 15, characterised in that the point (18) of the needle (17) opening into the second guide (14) is protected by a flexible, self-resealing cover (24), for example made out of latex.
17. Device according to any of the claims from 1 to 16, characterised in that it is independent from the solution pouch (16) and the flask (3).
18. Device according to claim 17, characterised in that the second guide (14) comprises means capable of impeding the total removal of the entry orifice (15) of the solution pouch (16) from the second guide (14) after its insertion therein.
19. Device according to claim 18, characterised in that the means impeding the removal of the entry orifice (15) have an identical structure to that of the means impeding the removal of the flask (3) from the first guide (2) and are arranged to allow the at least partial sliding of said entry orifice (15) into the second guide (14).
20. Device according to any of the claims from 1 to 16, characterised in that it is integrated in a permanent and non-detachable manner with the solution pouch (16).
21. Device according to claim 20, characterised in that it is mounted in a fixed manner on the entry orifice (15) of the solution pouch (16), at the level of the open end of the second guide (14).
22. Device according to claim 20 or 21, characterised in that it is further protected by a membrane seal resting on the longitudinal walls (4) of the first guide (2).
23. Device according to any of the claims from 1 to 22, characterised in that it is made out of an injectable and sterilisable plastic material.
24. Device according to claim 23, characterised in that it is made out of a polymer based on polyethylene, polycarbonate, polypropylene, polystyrene as well as the derivatives and/or mixtures of these products.

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