FR2869795A1 - Two-way liquid transfer unit, e.g. for chemotherapy fluid, has body with flask holder, partition, piston and hollow needle extractor - Google Patents

Abstract

The unit for transferring a liquid between a flask with a perforable stopper and a capsule consists of a body (16) with grippers (18) for a flask, a hollow needle (23) with ends (23a, 23b) to perforate the flask stopper and capsule piston, a mobile section (20) and an inner partition (22) between the body and piston. It incorporates an extractor for the removing the needle tip from the piston by moving the needle relative to the partition. It also has a guide for a flask support (16B), moved by means of a lug (47) and spiral groove (48).

Description

The present invention relates to a bidirectional transfer device

  a liquid between a bottle provided with a pierceable stopper and a cartridge comprising a cylindrical reservoir in which a perforable piston slides, of the type comprising:

  a body comprising means for hooking up the bottle; - a hollow needle having a first end for the perforation of the piston of the cartridge and a second end adapted for perforation of the cap of the bottle; a movable element displaceable relative to the body in the direction of the axis of the needle, which moving element comprises means for axially securing the tank of the cartridge in the direction of the axis of the needle; and - a spacer interposed between the body and the pierceable piston of the cartridge, which spacer forms a stopper of the pierceable piston relative to the body, the needle is movable relative to the spacer between a position engaged in the cartridge through the pierceable piston and a disengaged position away from the pierceable piston.

  Such a bidirectional transfer device is described in particular in the patent application FR-2,829,691.

  It is used in particular in the chemotherapy treatment of patients with cancer. Thus, the carpule initially contains a solvent, while the bottle is loaded with a cytotoxic active ingredient in powder form. The bidirectional transfer device makes it possible to ensure the reconstitution of the extemporaneous mixture consisting of the solvent and the cytotoxic active ingredient.

  For reconstitution, the solvent is transferred to the vial and then the reconstituted mixture is reintroduced into the carpule. The carpule is then unscrewed and removed from the device to be equipped at its front end with an injection needle and, at its rear end, a rod for actuating the piston.

  During these manipulations, the piston of the carpule previously crossed by the needle and the end of the needle having passed through the piston are ex-posed. These elements are soiled by the reconstituted mixture. When handling the device, solvent vapors and especially gaseous fumes resulting from the active ingredient escape into the atmosphere. These can be dangerous for the medical staff performing the manipulations.

  The invention aims to provide a bidirectional transfer device avoiding gaseous emissions into the atmosphere during handling.

  For this purpose, the subject of the invention is a bidirectional transfer device, of the aforementioned type, characterized in that it comprises means for disengaging the end of the needle stitched in the piston by displacement of the needle with respect to the spacer.

  According to particular embodiments, the transfer device comprises one or more of the following characteristics: the body comprises an envelope and a vial support, which support comprises the attachment means of the vial and is mobile at least according to the invention; the axis of the needle relative to the casing, the casing and the spacer comprise complementary means of axial connection and the hollow needle is carried by the vial support and is fixed axially with respect to the vial support, and the disengagement means comprise a maneuvering profile of the vial support for its displacement at least axial relative to the casing to ensure axial movement of the needle relative to the spacer; the body comprises means for guiding the vial support with respect to the casing for a helical displacement of the vial support with respect to the casing; said guide means comprise at least one helical slot formed in one of the vial support and the casing and one peg carried by the other of the vial support and the casing, which peg is movable in said slot; the movable element defines a housing for immobilizing the carpule and comprises a needle holder equipped with a through needle, which needle holder is sliding relative to the housing between an initial position in which the needle is at the distance from the carpule and a final position in which the needle is engaged in the carpule; the movable element comprises a cap supporting the needle holder and the needle is completely contained in the cap in the initial position and in the final position of the needle holder, the cap comprising an access orifice to the needle holder; needle; - said spacer is movable relative to the body between an initial position in which it maintains the piercable piston away from the first end of the needle and a final position in which the needle is engaged through the pierceable piston; - The movable assembly and the body comprise means for limiting the movement of the moving element relative to the body in the direction of extraction of the pierceable piston out of the cylindrical reservoir; and the mobile assembly and the body comprise means for guiding in translation and immobilizing in rotation of one with respect to the other.

  The invention will be better understood when reading the. description which follows, given solely by way of example and with reference to the drawings, in which: FIG. 1 is a perspective view of the transfer device according to the invention; - Figure 2 is an exploded perspective view of the transfer device of Figure 1 associated with a bottle and a carpule; - Figure 3 is a longitudinal sectional view of the transfer device shown without bottle or cartridge; and - Figures 4, 5, 6, 7, 8 and 9 are longitudinal sectional views of the transfer device associated with a bottle and a carpule, shown at successive stages of use.

  The transfer device 10 shown in FIG. 1 is generally cylindrical in shape of the X-X axis. It is adapted to first ensure the bidirectional transfer of a fluid between a cartridge 12, visible in particular in Figures 2 and 4, and a bottle 14, visible in these figures and to then allow injection from the cartridge 12 an extemporaneous mixture.

  The device 10 essentially comprises a body 16 having, at a lower end, means 18 for attaching the bottle 14, a mobile assembly 20 for supporting and moving the body of the cartridge 12, this equipment being adapted to slide relative to the body 16 and a spacer 22 forming a pusher adapted to bear on the piston of the cartridge 12.

  The device further comprises a hollow transfer needle 23 carried by the body 16 and visible in FIG. 3, as well as an injection needle 24 capable of transferring the reconstituted mixture of the cartridge to an external element such as a pouch. infusion.

  As known per se and as illustrated in FIG. 4, the carpule 12 comprises a cylindrical reservoir 25 having, at the front, a narrowed neck closed by a perforable lid 26. The lid 26 is adapted to be perforated by the needle The cartridge further comprises a perforable piston 27 axially slidable within the reservoir 25. Initially, the cartridge contains a solvent.

  The bottle 14 comprises a glass body having a neck closed by a perforable lid 28. The neck has a peripheral rim defining a shoulder 29. Initially, the bottle 14 contains a lyophilisate to be dissolved in the solvent contained in the carpule. Alternatively, the bottle 14 contains a liquid suitable for mixing with the solvent of the carpule.

  As illustrated in the figures, the body 16 generally has a tubular shape. It comprises a generally cylindrical casing 16A inside which is received a support 16B for the bottle 14. The support 16B is movable at least along the X-X axis of the needle 23 with respect to the casing 16A. In the embodiment envisaged, the support is movable in a helical race with respect to the envelope 16A.

  More specifically, the bottle holder 16B forms a cap 30 defining a housing 31 for receiving the bottle 14. The housing 31 is defined by a cylindrical wall 32 closed by a bowl 34 for receiving the neck of the bottle 14. The bowl 34 is delimited laterally by a cylindrical wall 36 of smaller diameter than that of the cylindrical wall 32. It is closed by a transverse wall 37 forming a bottom. The bowl is connected to the cylindrical wall 32 by a frustoconical section 38.

  The means 18 of attachment of the bottle are formed on the inner surface of the cylindrical wall 32. They consist of projections 40 adapted to ensure axial retention of the bottle by resilient engagement behind the neck of the bottle.

  The bottom 37 of the cuvette is crossed axially by the transfer needle 23. This needle is retained by a collar 42 projecting from the housing 30. The collar 42 provides axial solidarity of the body 16 and the needle 23.

  The needle 23 has a first end 23A projecting inside the housing 30. This end is adapted to perforate the seal 28 closing the vial 14.

  The needle 23 extends on the other side of the bottom 37 over most of the length of the body 16. It has on this side of the bottom 37 a 23B perforation end of the piston 27 of the cartridge.

  At its free end, the support 16B externally has a knurled flange 43 which protrudes radially out of the casing at its end and allows the handling of the support 16B for its displacement relative to the casing 16A.

  The envelope 16A is formed of a tubular trunk 44 of constant section extended at one end by a section 45 of enlarged diameter enveloping the bottle holder 16B. The tubular trunk 44 surrounds the side wall 36. An annular space 46 is defined between the cylindrical wall 36 and the lower end of the tubular trunk 44.

  To ensure the displacement of the support 16B with respect to the envelope 16A in a helix, the cylindrical wall 32 of the vial support is externally provided with a pin 47 received in a helical slot 48 formed in the section 45 of enlarged diameter of the 'envelope. In a variant, the pin and the slot are reversed.

  The tubular trunk 44 has longitudinal lumens and windows providing elastic engagement with projections provided on the moving assembly 20 and on the spacer 22.

  The spacer 22 has, at a lower end, a base 60 in the form of a bell adapted to engage around the bowl 34. At its other free end, it has a profile 62 for hooking and bearing on the piston of the carpule.

  More specifically, the spacer 22 has a cylindrical wall 64 axially surrounding the needle 23. The outer diameter of the cylindrical wall 64 is smaller than the inside diameter of the tank 25 of the cartridge, to allow the spacer to enter the chamber. cartridge.

  The base 60 is integral with the end of the cylindrical wall 64. This base has a peripheral skirt 66 adapted to be received in the annular space 46. This skirt is connected to the cylindrical wall 64 by a ring 68.

  At its free end, the skirt 66 externally has two diametrically opposed snap protrusions 70. These projections are adapted to be received, as shown in Figure 3, in two windows 72 formed in the tubular trunk 44 of the body. These windows 72 are arranged away from the cap 30.

  Two identical windows 74 are formed in the vicinity of the cap 30 and are adapted to receive the latching projections 70 after displacement of the spacer 22 along the needle 23 in the direction of the bottle 14.

  At the other end of the cylindrical wall 64, the attachment and support profile 62 of the pierceable piston of the carpule comprises a threaded end 75 extending axially in the extension of the cylindrical wall 64. This threaded end has a outer diameter reduced and has an external thread adapted to cooperate with a thread formed in a threaded recess of the pierceable piston 27 of the cartridge.

  A shoulder 76 is provided at the end of the cylindrical wall 64 to ensure the connection of this wall 64 to the nozzle 75. This shoulder also allows the axial support of the piston 27 of the cartridge.

  The endpiece 75 is extended inside the cylindrical body by a collar 77. The endpiece 75 and the collar 77 internally define a passage 78 for guiding the needle 23 and in particular its end section terminated by the perforation end 23B. The dimensions of the needle 23 and the various components of the spacer 22 are such that, when the spacer 22 is in its initial position, with the latching projections 70 received in the windows 72 (FIGS. ), the perforation end 23B of the needle is disposed inside the passage 78, away from the piston 27.

  The mobile unit 20 for supporting and moving the reservoir of the carpule comprises a carpule holder 80 and a cap 82 screwed onto the carpule support. Between these is delimited a housing 84 of axial immobilization of the reservoir 25 of the carpule. The moving element further comprises a sliding needle holder 83 mounted in the cap 82 and able to perforate the lid 26 of the cap by sliding relative to the housing 84 in which the cartridge is immobilized.

  The carpule support 80 forms a tubular section 86 whose inside diameter corresponds to the outside diameter of the tank 25 of the carpule. This tubular section has on its outer surface a tapping adapted to cooperate with a complementary thread formed at the end of the cap 82. The latter has a cylindrical side wall 87 in which is partially received the tubular section 86 of the carpule support. This side wall 87 is lined at its free end by an outer flange 88 forming a bearing surface for the hand. The cap is pierced at its free end with a hole 88A allowing the introduction of the nose of an infusion bag.

  At its end opposite the cap 82, the cartridge holder 80 has a ring 91 surrounding the tubular section 86. This ring forms a shoulder for the support of the rear end of the reservoir 25. The ring 91 is extended by a peripheral lip 92 surrounding the cylindrical wall 64 of the spacer to ensure axial guidance of the moving element 20 relative to the spacer 22.

  In addition, the support 80 has an outer skirt 94 surrounding the tubular section 86 between the threading for the connection of the cap 82 and the end of the section 86 equipped with the lip 92. This skirt 94 has a pair of protrusions ex- laterally. ratchet 98 diametrically opposed and adapted to be received initially in two windows 100 housed in the vicinity of the upper end of the tubular portion of the body.

  In addition, a flange 104 for guiding is provided outside the free end of the cylindrical section 86. It bears on the inner surface of the tubular trunk 44.

  Diametrically opposed longitudinal slots 106 extend substantially along the length of the tubular trunk 44 of the body. They are adapted to receive the protrusions 98.

  A marking forming a graduated scale is carried by the tubular trunk 44 along the longitudinal slots 106. This marking is adapted to cooperate with the projections 98 which then form slider. The position of the salts along this marking indicates the volume of product contained in the carpule.

  Alternatively, the graduated scale is provided on the cap 82 and the end of the tubular trunk 44 serves as a movable slider along the scale to indicate the volume of liquid contained in the carpule.

  In the needle holder 83, the needle 24 extends along the X-X axis of the device. This needle has a first beveled end 24A rotated to the lid 26 of the carpule and clean to perforate the latter. The second end, noted 24B of the needle, is also beveled and is able to perforate the nose of an infusion bag.

  The needle holder 83 externally comprises a cylindrical sleeve 112 capable of sliding inside the cylindrical wall of the cap 82. A transverse wall 114, integral with the sleeve 112, is traversed at its center by the hollow needle 24. This latter is held by an axial stud 116 provided at the center of the transverse wall 114.

  An elastically deformable cap 118 completely covers the portion of the hollow needle 24 projecting away from the cartridge 26. The cap 118 is retained on the pin 116 and is adapted to deform bellows along the needle 110 after having been perforated by the bevelled end 24B thereof.

  The needle 24 and the sleeve 112 are always completely received in the cylindrical wall 82, between its two ends.

  The operation of the transfer device will now be described with reference to FIGS. 3 to 9.

  The device is initially in the storage state shown in FIG. 3. In this state, no vial or cartridge is placed in the device.

  The carpule 12 is first put in place in the moving assembly 20, as illustrated in FIG. 4. For this purpose, the cap 82 is unscrewed from the carpule holder 80. The carpule is then introduced with its rear end engaged in the space delimited by the cylindrical section 86. The pierceable pis-ton 27 is screwed onto the endpiece 75 of the spacer. In this position, the rear end of the cartridge bears against the ring 91 of the cartridge holder 80. The cap 82 is then screwed onto the cartridge holder 80. This screwing is performed until the transverse wall 90 of the cap bears on the front end of the cartridge, so that the reservoir 25 of the carpule is secured axially relative to the moving assembly 20.

  A device can make the cap unmountable after placement of the carpule, avoiding any risk of contact with the drug after reconstitution.

  The bottle 14 is then engaged in the housing 31, as illustrated in Figure 4. The bottle 14 is retained in the housing 31 by the resilient engagement projections 40 applied against the shoulder 29.

  When placing the neck in the cap 30, the seal 28 is perforated by the transfer needle 23 from its end 23A.

  In this position, a pressing force is then applied to the cap 82 to bring it closer to the body 16. Under the action of this pressure, the projections 70 initially immobilizing the spacer 22 in its initial position emerge from the windows 72, thus allowing displacement of the spacer 22 and the pierceable piston 27 secured thereto towards the bottle 14 along the needle 23. This movement takes place until the projections of latching 70 are received in the windows 74.

  Simultaneously, the moving element 20 is caused to move with respect to the body 16. In particular, the detent projections 98 emerge from the windows 100, thus allowing the mobile assembly 20 to slide inside the tubular trunk. 44 of the body.

  During this movement, the piston 27 of the cartridge is perforated by the end 23B of the needle, so that, after the displacement of the spacer 22, and as shown in Figure 5, the bottle 14 and the carpule 12 are communicated through the needle 23.

  When continuing the movement, the perforated piston 27 of the cartridge is held in abutment on the spacer 22 and is thus immobilized relative to the body. The body of the carpule being displaced by the sliding of the moving element 20, a relative displacement between the piston 27 and the reservoir 25 of carpule occurs, the piston gradually sinking into the reservoir. The liquid contained in the carpule is then ejected through the needle 23 into the bottle 14.

  The projections 98 received in the longitudinal slots 106 provide a guide in translation and immobilization in rotation of the moving element relative to the body.

  Displacement occurs until the piston 27 reaches the front end of the cartridge, as shown in FIG.

  In this position, the device is slightly shaken to ensure dissolution of the lyophilisate in the solvent initially contained in the carpule.

  To cause a new transfer of the mixture contained in the bottle 14, the device is completely returned. Thus, the bottle 14 is above the carpule. In particular, the end 23A of the needle is in the lower part of the vial allowing suction sampling of most of the contained mixture. The suction is provided by the moving assembly 20 which is brought away from the bottle 14. For this purpose, the body 16 is held in one hand while the cap 82 is pulled in the direction of the needle. During this movement, the piston 27 traversed by the needle 23 is held immobilized relative to the body by the engagement of the latching projections 70 in the windows 74. On the contrary, the movable assembly 20 which is secured to the cylindrical reservoir 25 moves inside the body in the direction of the needle 23, so that the piston moves relative to the cylindrical reservoir, thereby creating a depression in the carpule, which causes the recall of the mixture contained in the bottle 14.

  The displacement of the moving element 20 is interrupted when the detent projections 98 reach the upper end of the longitudinal slots 106. The presence of the protrusions 98 and stop stops formed by the ends of the slots 106 allows the travel of the mobile assembly 20 is limited, thus avoiding any risk of accidental disengagement of the piston 27 from the tank 25 and fixing the maximum filling volume of the cartridge by imposing the position of the piston in the cartridge.

  In this position, most of the reconstituted mixture in the bottle 14 is transferred into the cartridge 12. The bottle holder 16B is then moved with the needle 23 away from the piston 27, by manual action on the collar 43. For this purpose, the bottle support 16B and the bottle 14 that it contains are moved in a helical race defined by the displacement of the pin 47 in the slot 48. During this movement, the end 23B disengages from the pierceable piston 27 of the carpule, the needle being driven with the bottle holder 16B.

  The nose of an infusion bag into which the mixture must be introduced is then engaged in the open end of the cap 82. When the nose of the bag is pushed in, the cap 118 is pierced by the end 24B of the needle and is compressed along it. The end 24B of the needle penetrates the bag by perforating the nose thereof. Simultaneously, the end 24A of the needle perforates the cap 26 of the carpule. The needle 24 then enters the carpule, during the displacement of the needle holder 83 under the action of the depression of the nose of the infusion bag.

  The device is then ready for injecting the mixture contained in the carpule inside the pocket. The cap 82 and the envelope 16B are then brought closer to one another. The piston 27, held in abutment on the spacer 22, is then displaced along the length of the tank 25 of the cartridge as the hood 82 is pushed into the body 16. Thus, the mixture contained in the carpule is gradually injected into the pocket through the needle 24. A determined quantity of the mixture contained in the carpule is injected through the use of the graduated scale provided on the trunk 44 along the slots 106 or on the cap 82.

  This injection is made possible by the release of the needle 23 from the piston 27 before the piston is displaced along the length of the cartridge. In fact, this initial clearance of the needle makes it possible to form in the carpule a confined space which is open only through the needle 24. Thus, the mixture can be ejected from the carpule without this being disassembled from the device.

  At the end of the transfer, the nose of the pocket is clear of the cap 82.

  The needle 24 then emerges from the nose of the pocket and the end 24B of the needle is progressively covered by the elastic cap 118.

  The needle holder 83 and the needle 24 remain fully engaged in the cap 82.

  It is understood that with such a device, no gas evolution of the reconstituted mixture in the flask 14 escapes into the atmosphere, the moving parts come into contact with the mixture, namely the needles 23 and 24, the carpule 12 and the bottle 14, always being enclosed in the body of the device or covered by the cap 118.

  As a variant, the device does not have a sliding needle holder 83 permanently attached to the cap 82. A double-pointed needle is then attached to the end of the cartridge, only after filling the cartridge with the mixture. extemporaneous, to proceed to the injection.

  According to yet another variant, the section of the needle 24 ending in the end 24B is replaced by a nasal tip consisting of a cannula for the diffusion of the mixture contained in the carpule in the nose of a patient and not his injection into a pocket.

Claims (9)

  1.- Device (10) for bi-directional transfer of a liquid between a bottle (14) provided with a pierceable stopper (28) and a cartridge (12) comprising a cylindrical reservoir (25) in which a pierceable piston (27) slides. ), the device comprising: - a body (16) comprising means (18) for hooking up the bottle (14); - a hollow needle (23) having a first end (23B) for perforation of the piston (27) of the cartridge and a second end (23A) adapted for perforation of the cap (28) of the bottle (14); - A movable element (20) displaceable relative to the body (16) in the direction of the axis of the needle (23), which movable element (20) comprises means for axially securing the reservoir (25) of the cartridge in the direction of the axis of the needle (23); and - a spacer (22) interposed between the body (16) and the pierceable piston (27) of the cartridge, which spacer (22) forms a stopper of the pierceable piston (27) relative to the body (16), the needle (23) is movable relative to the spacer (22) between a position engaged in the cartridge through the pierceable piston (27) and a position disengaged away from the pierceable piston (27) characterized in that it comprises means for disengaging the end (23B) of the needle stuck in the piston (27) by displacement of the needle (23) with respect to the spacer (22).   2.- transfer device according to claim 1, characterized in that the body (16) comprises a casing (16A) and a support (16B) vial, which support (16B) comprises the means (18) of attachment of the bottle and is movable at least along the axis (XX) of the needle (23) relative to the casing (16A), in that the casing (16A) and the spacer (22) comprise complementary means axial connection and the hollow needle (23) is carried by the vial support (16B) and is fixed axially with respect to the vial support (16B), and in that the release means comprise a carrier maneuvering profile vial (16B) for its movement at least axial relative to the casing (16B) to ensure axial displacement of the needle (23) relative to the spacer (22).   3.- transfer device according to claim 2, characterized in that the body (16) comprises means for guiding the bottle holder (16B) relative to the casing (16A) for a propeller movement of the bottle holder (16B) relative to the envelope (16A).   4.- transfer device according to claim 3, characterized in that said guide means comprise at least one slot (48) helically formed in one of the bottle holder (16B) and the envelope (16A) and a pin (47) carried by the other of the vial support (16B) and the casing (16A), which pin (47) is movable in said slot (48).   5.- transfer device according to any one of claims 1 to 4, characterized in that the movable element (20) defines a housing (84) for immobilizing the cartridge (12) and comprises a needle holder ( 83) having a needle (24) therethrough, which needle holder (83) is slidable relative to the housing (84) between an initial position in which the needle (24) is away from the cartridge (12). ) and a final position in which the needle (24) is engaged in the cartridge (12).   6.- transfer device according to claim 5, characterized in that the movable element (20) comprises a cap (82) supporting the needle port (83) and in that the needle (24) is completely contained in the cap (82) in the initial position and in the end position of the needle holder (83), the cap (82) having a needle access port (88A) (24).   7.- transfer device according to any one of the preceding claims, characterized in that said spacer (22) is movable relative to the body (16) between an initial position in which it maintains the pierceable piston (27) to the distance from the first end (23B) of the needle and a final position in which the needle (23) is engaged through the pierceable piston (27).   8.- transfer device according to any one of the preceding claims, characterized in that the movable element (20) and the body (16) comprise means (98, 106) for limiting the displacement of the moving element ( 20) relative to the body (16) in the direction of extraction of the pierceable piston (27) out of the cylindrical reservoir (25).   9. A transfer device according to any one of the preceding claims, characterized in that the movable element (20) and the body (16) comprise means (104, 106) for guiding in translation and immobilization in rotation. from one to the other.