FR2790749A1 - DEVICE FOR TRANSFERRING A SUBSTANCE CONTAINED IN A BOTTLE INTO A POUCH OF 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

I The invention relates to a device for transferring a substance,

for example

  medication, inside a pocket.

  The care provided in a hospital environment frequently requires passing a drug in liquid or solid form, contained in a bottle,

in a solution pocket.

  The contents of the solution bag, for example glucose to which the drug is added, is then administered to the patient continuously, by

  example using a conventional infusion device.

  There is thus known a transfer device comprising a first part, intended to be mounted on the inlet orifice of a pocket, 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 on the one hand to pierce the stopper of the bottle, generally made of rubber, as well as the inlet opening of the pocket, then to transfer the contents

  from the bottle in the pocket on the other hand.

  To carry out 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 bottle is mounted on the second part of the device, the needle also piercing the stopper

rubber of the bottle.

  When the bottle and the bag are thus mounted on the device, the interior of the

  bottle and the inside of the pocket are in communication.

  By compressing and then releasing the solution bag, a vacuum is established, allowing the medication to pass from the vial to the solution bag. Once the medicine is transferred, the vial and the transfer device are

  usually removed from the pocket.

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

  This system has drawbacks, however.

  io Both in terms of safety for the patient and in practical terms for the

hospital nursing staff.

  In terms of security, there is in fact no means of control, after the transfer made and the transfer device removed from the bag, that the bag actually contains the transferred medicine on the one hand, and that it is indeed the

medication prescribed on the other hand.

  In addition, medication transfers can be made to the patient's bed, and hospital staff must assemble the solution bags on site,

  transfer devices and vials.

  This therefore results in possible errors in the handling of the devices, as well as the need to transport throughout the day, all of the

elements necessary for care.

  This also results in a loss of time for the nursing staff

  hospital, when preparing medication transfers.

  The invention aims to remedy these drawbacks by proposing a transfer device which makes it possible to control the nature of the product transferred and the correct

completion of this transfer.

  And which also makes it possible to carry out the transfers of drugs to the central pharmacy of the hospital, the nursing staff having only, at the patient's bed, to operate the drug administration, without having to assemble the

  different elements between them, and this in complete safety.

  To this end, the device for transferring a substance, for example a medicinal substance, contained in a container, such as a vial, into a solute bag, comprises a first guide, of generally substantially cylindrical shape, open to the one of its ends and closed at its other end opposite the end

o open.

  The first guide is capable of receiving 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 also includes means capable of preventing withdrawal

  total of the bottle out of the first guide after its introduction therein.

  The device according to the invention further comprises a second guide, of generally substantially cylindrical shape, extending the first guide from the 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 suitable for

  receive the inlet port 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 so coaxial with the first and

second guides.

  According to other characteristics and a particular embodiment of the invention, the means preventing the withdrawal of the bottle comprise at least one elastic tab formed on the internal face of the first guide, for example at the level

  from the open end of the first guide.

  The tab projects from one of its ends towards the inside of the first guide while being directed towards the closed end of the first guide. For example, the internal face of the first guide may comprise three elastic tabs arranged in a substantially regular manner between them and

  substantially at the same level on the internal face of the first guide.

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

first guide.

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

  According to the invention, the second guide can be rigidly fixed 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 the open end of the second guide and intended to slide in an opening of corresponding diameter made in the end closed from

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 the latter, so as to block

  the sliding of the second guide in the first guide.

  The means for piercing the means for closing the bottle and the inlet orifice of the bag comprise a hollow needle over its entire length,

  coaxial with the first and second guides.

  The two ends of the needle are in the form of bevelled points, opening for one in the first guide and for the other in the second

io guide.

  In the alternative embodiment according to 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 according to 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 can be independent of the storage bag.

  solution and bottle, the various elements being assembled before transfer.

  Alternatively, the transfer device according to the invention can be integrated, so

  permanent and not detachable, with a solution pocket.

  For example, the transfer device of the invention can be fixedly mounted on the inlet opening of a solute bag, at the open end

from the second guide.

  In this case, the user only has to introduce the bottle into the first guide,

before proceeding with the transfer.

  According to this variant, the tip of the needle situated on the side of the solution 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 located on the side of the solution bag does not need to be beveled, since it no longer pierces the inlet opening of the bag

of solute.

  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 cover resting on the longitudinal walls of the first

guide.

  The invention will be better understood in the description which follows, given with reference

to the appended figures.

  FIG. 1 represents a schematic view, in longitudinal section, of a mode

  for producing the transfer device of the invention.

  Figure 2 shows 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 the

figure 2.

  Referring now to FIG. 1, the transfer device 1 according to the invention comprises a first guide 2 capable of receiving, at least partially,

a bottle 3.

  The first guide 2 is generally cylindrical in shape, the shape of the first

  guide depending on that of the bottle.

  Thus, the first guide can be of a shape other than cylindrical, for example parallelepipedal, to adapt to bottles of a corresponding shape. The first guide 2 comprises a longitudinal wall 4 open to one of its

  ends 6 and closed at its opposite end 5.

  0o 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.

  According to the embodiment shown in Figure 1, the means preventing withdrawal include two elastic tabs 7 disposed on the inner face 8 of the longitudinal wall 4 of the first guide 2. The two tabs 7 are arranged so as to allow the introduction of the bottle 3

  in the first guide 2 and to prevent its total withdrawal out of it.

  According to the embodiment shown, the legs 7 deviate towards the face

  internal 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 neck 9 has passed, 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 located at the legs 7.

  The tabs 7 can then again move away towards the internal face 8 of the

  first guide 2, to allow passage of the body 11 of the bottle 3.

  The legs 7 are fixed to the internal face 8 of the first guide 2 by one of their ends 12, the other free end 13 of the legs 7 being directed towards the closed end of the first guide 2, so as to block the withdrawal from bottle 3

  outside the first guide 2, at the neck 10 of the bottle 3.

  The number of tabs 7 can vary depending in particular on the resistance to shrinkage which it is desired to impart to the transfer device 1 of the invention. According to one embodiment, the transfer device 1 comprises three tabs 7 disposed substantially at the same level of the internal face 8 of the first

  guide 2 and spaced substantially evenly therebetween.

  O10 The first guide 2 is extended on the side of the closed end 5 by a second

guide 14.

  According to the embodiment represented in FIG. 1, the second guide 14 is disposed in a fixed and coaxial manner, relative 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 orifice 15 of a

solution bag 16.

  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 bevelled points 18, intended to pierce the inlet orifice 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 points 18 of the needle 17 opening for one in

  the first guide 2 and for the other in the second guide 14.

  One can provide a region 19 forming a base on the side of the closed end 5 of the first guide 2 (or, alternatively, on the side of the second guide 14) for

  strengthen the rigidity of the needle 17.

  In particular, the base region 19 prevents the needle 17 from twisting when piercing the stopper of the bottle 3 or the inlet orifice 15 of the

solution bag 16.

  The transfer device 1 can be made of an injectable plastic.

  The plastic used must also be able to withstand the sterilization conditions. For example, the transfer device can be made of a polymer based on polyethylene, polycarbonate, polypropylene, polystyrene, as well as the

  derivatives and / or mixtures of these products.

  The transfer device shown in Figure 1 is manufactured by injection, from the raw materials indicated above, the first and second guides

  being formed in one piece and the needle molded.

  Another embodiment of the transfer device 1 is shown in the

figure 2.

  In FIG. 2, the same reference numbers correspond to the same elements as those described in relation to FIG. 1 and will therefore not be

detailed in the following.

  Referring now to the embodiment shown in Figure 2, the transfer device 1 comprises a first guide 2 and a second guide 14

  into which open the points 18 of a needle 17.

  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 medication contained in a bottle. To do this, the second guide 14 comprises a region of smaller external diameter 20, located at the end of the second guide 14 located on the side of the first

guide 2.

  This region of smaller external diameter 20 is slidably mounted in a corresponding opening made 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 external 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 depositing a silicone material on

  the region with the smallest external 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 at its normal diameter, at region 22.

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

to the first and second guides.

  FIGS. 3, 4, 5 and 6 illustrate the operation of the transfer device according to the invention. In Figures 3 to 6, the same reference numerals designate the same elements as in Figures 1 and 2. Referring now to these figures, a transfer device 1 according to the invention is mounted, by means of the second guide 14, on the hole

  inlet 15 of a solute bag 16 (Figure 3).

  The point 18 of the needle 17 located on the side of the second guide 14 pierces the operculum

  23 closing the inlet orifice 15 of the pocket 16.

  The other point 18 of the needle 17 located on the side of the first guide 2 is protected by a flexible self-sealing envelope 24, for example made of latex, for the purpose

  guarantee sterilization of the transfer device 1.

  Such an envelope 24 can also be provided on the side of the point 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 medicament is introduced into the first

guide 2 (figures 4 and 5).

  The elastic tabs 7 move apart against the internal face 8 of the first guide 2 to allow the passage of the neck 9 of the bottle 3, return to their initial position when the neck 9 of the bottle 3 passes (FIG. 4) and then move away from new

  for the passage of the body 11 of the bottle 3 (Figure 5).

  The stopper of the bottle 3 then comes into contact with the point 18 of the needle 17

protected by the casing 24.

  A further sliding of the bottle 3 then causes, thanks to the needle 17, the piercing of the stopper and of the casing 24, bringing the interior of the bottle 3 into communication with the interior of the solute bag 16, by the intermediate

of the hollow needle 17 (FIG. 6).

  The solute bag 16 is positioned with the inlet orifice 15 facing downwards in order 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 solution bag 16 and bottle 3 assembly is turned over in order to transfer the contents of the bottle 3 into the solution bag 16, the sterile air of the solution bag 16 replacing the liquid contained

in bottle 3.

  Once the transfer is complete, the bottle 3 remains on the device 1 according to the invention, its withdrawal being prevented by the tabs 7 which block the passage of the neck 9

outside the first guide 2.

Claims (22)

  1. Device (1) for transferring, in a solute bag (16), a substance, for example a drug, contained in a container, such as a bottle (3), comprising: - a first guide (2) , of generally substantially cylindrical shape, open at one of its ends (6) and closed at its other end (5) opposite the open end (6), the first guide (2) being able to receive at least the neck (10) and the upper part of the body (11) of the bottle (3), the bottle (3) being 1o capable of sliding at least partially in the first guide (2); the first guide (2) comprising means capable of preventing the total withdrawal of the bottle (3) from the first guide (2) after its introduction therein; - A second guide (14), of generally substantially cylindrical shape, extending the first guide (2) on the side of 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 inlet orifice (15) of the solute bag (16); a means of piercing means for closing the bottle (3) and the solute bag (16) respectively, and for transferring the substance contained in the bottle (3) into the solute bag (16), the means for drilling being arranged   coaxially with the first (2) and second (14) guides.   2. Device according to claim 1, characterized in that the means preventing the withdrawal of the bottle (3) comprise at least one elastic tab (7) formed on the internal face (8) of the first guide (2), for example at the level from the open end (6) of the first guide (2), the tab (7) projecting towards the inside of the first guide (2) through one of its ends (13) being directed   towards the closed end (5) of the first guide (2).   3. Device according to claim 2, characterized in that the tabs (7) are fixed to the internal face (8) of the first guide (2) by one of their ends (12), the other end (13) legs (7) being directed towards the closed end (5) of the first guide (2).   4. Device according to claim 2 or 3, characterized in that it comprises three elastic tabs (7) arranged in a substantially regular manner between them and   substantially at the same level on the internal face (8) of the first guide (2).   5. Device according to claim 1, characterized in that the means preventing the withdrawal of the bottle (3) comprise at least one elastic annular lip disposed on the internal 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 axis   longitudinal (X) of the first guide (2).   6. Device according to any one of claims 1 to 5, characterized in that   that the second guide (14) is rigidly fixed on the first guide (2).   7. Device according to any one of claims 1 to 5, characterized in that   that the second guide (14) is slidably mounted on the first guide (2). 8. Device according to claim 7, characterized in that the second guide (14) comprises a region of smaller external diameter (20), located towards the end of the second guide (14) opposite the open end of the second guide (14) and intended to slide in an opening of corresponding diameter   formed in the closed end (5) of the first guide (2).   9. Device according to claim 8, characterized in that the end portion of the region of smaller diameter (20) located on the side of the first guide (2) is provided with an annular lip (21) forming a bearing surface against the closed end (5) of the first guide (2), inside of it, so as to block the   sliding of the second guide (14) in the first guide (2).   10. Device according to claim 8 or 9, characterized in that the region of   smaller diameter (20) is coated with a silicone material.   11. Device according to any one of claims 1 to 10, characterized in   that the means for piercing the means for closing the bottle (3) and the inlet orifice (15) of the pocket (16) comprise a needle (17) hollow over 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), opening for one in the first guide (2) and for the other in the second guide (14).   1o 12. Device according to claim 11, characterized 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, characterized in that it comprises a base region (19) on the side of the closed end (5) of the first guide (2) or, alternatively, on the side of the second guide (14) , to reinforce the rigidity of the needle (17).   14. Device according to claim 11, characterized in that the needle (17) is held in place at the region of smaller diameter (20) of the second guide (14).   15. Device according to any one of claims 11 to 14, characterized in   that the point (18) of the needle (17) opening into the first guide (2) is   protected by a flexible envelope (24), for example made of latex.   16. Device according to any one of claims 11 to 15, characterized in   that the point (18) of the needle (17) opening into the second guide (14) is   protected by a flexible self-resealing envelope (24), for example made of latex.   17. Device according to any one of claims 1 to 16, characterized in   which is independent of the solute bag (16) and the bottle (3).   18. Device according to any one of claims 1 to 16, characterized in   that it is permanently integrated and not detachable to the solute bag (16). 19. Device according to claim 18, characterized in that it is fixedly mounted on the inlet orifice (15) of the solute bag (16), at   the open end of the second guide (14).   20. Device according to claim 18 or 19, characterized in that it is further protected by a cover resting on the longitudinal walls (4) of the first guide (2).   21. Device according to any one of claims 1 to 20, characterized in   what it is made of injectable and sterilizable plastic.   22. Device according to claim 21, characterized in that it is produced from a polymer based on polyethylene, polycarbonate, polypropylene,   polystyrene as well as the derivatives and / or mixtures of these products.