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    • 专利摘要:
    ADAPTER AND DRUG APPLICATION DEVICE. The present invention relates to a drug delivery device (1) comprising: a reservoir (20) for containing a product, said reservoir having an end piece projecting distally (21) with a longitudinal axis A and defining a channel providing a passageway for transferring the product from the reservoir, an adapter having a collar (30) engageable with said end piece, fixing device for locking said collar in the distal direction with respect to the end piece once the said collar is engaged around said end piece, anti-rotation device to prevent rotation of said collar with respect to said end piece around said longitudinal axis A under the effect of a turning torque applied to said collar, said collar is engaged around said end piece, deactivation device to neutralize said anti-rotation device once said turning torque has reached a predetermined value , thus allowing the rotation of said collar with respect to said end. The invention also relates to such an adapter.
    公开号:BR112013013132B1
    申请号:R112013013132-2
    申请日:2010-12-16
    公开日:2020-10-13
    发明作者:Michel Bosshardt；Benoit Guillard
    申请人:Becton Dickinson France；
    IPC主号:
    专利说明:

    Field of the Invention
    [001] The present invention relates to an adapter for a drug delivery device having an end piece, or adapted for use used with it, the adapter has an interlockable collar around said part and enables the secure connection of a connector to said collar. The invention further relates to a drug delivery device comprising such an attachable adapter. Fundamentals of the Invention
    [002] Drug delivery devices generally comprise a hollow body forming a reservoir for containing a medical product. In addition, the distal end of the body that forms the reservoir generally comprises an end piece in which an axial passageway is arranged through which said product is ejected from the reservoir.
    [003] In this order, the distal end of a component or device needs to be understood as the farthest end of the user's hand the proximal end needs to be understood as the end closest to the user's hand. Similarly, in this order, the distal direction needs to be understood as the direction of injection or transfer of the product (that is, from the reservoir to the intravenous line) and the proximal direction is the opposite direction.
    [004] Furthermore, the reservoir and the end piece of a drug delivery device can be made of various materials such as glass or plastic. When it is known that the stability of the product stored in the reservoir is not impacted by the nature of the plastic on the reservoir wall, it is desirable to have a drug application device made of plastic materials, in order to avoid the common risks associated with material handling of glass. Indeed, when drug delivery devices made of glass material happen to break down, not only is the product they contain contained lost, but the resulting pieces of glass material are a danger to the people around them. In addition, the loss of product can also create a danger when such a product is, for example, a toxic drug.
    [005] It is also desirable to have drug delivery devices made of plastic materials when these drug delivery devices are preloaded with the product and supplied to the end user in a preloaded state: the risks of breaking the delivery device of drug during the various operations before its use, such as the pre-loading, sterilization, packaging, transport, storage steps, are then substantially limited.
    [006] The handling of products, such as liquid medicine, in particular for parenteral administration to a patient, which is performed via a perfusion device, as often in hospitals or in emergency situations, generally implies , in the use of connectors, such as IV (intravenous) connectors that connect the drug delivery device, containing the product to be applied, to the patient's vein, usually via an IV line. Certainly, the drug delivery device, in particular its end piece and connector, need to be assembled correctly and safely.
    [007] In this respect, the drug delivery device generally comprises an external collar surrounding the end piece, that collar is intended to be connected to a connector in order to facilitate the transfer of the product from the end piece of the delivery device. application of drug to the connector, and then on line IV.
    [008] The moment the connector is connected to the collar, it is subjected to a tension resulting from the force applied in order to connect the connector to it. The intensity of the applied force can vary depending on the way the connector is connected to the collar: the inner wall of the collar is usually provided with a thread and the connector is connected to the collar by threading. The intensity of the force applied during the threading step depends on the user. A first consequence is that the tension to which the collar is subjected when the connector is connected to it is not controllable.
    [009] Furthermore, it happens that the collar surrounding the end piece of the drug delivery device breaks or cracks the moment it is subjected to the tension necessary to connect the connector, for example, because the user threads the connector inside the collar with a very high force and not for threading on the spot. In such a case, the connector is not securely and correctly connected to the terminal part of the drug delivery device, and drug administration is impossible or, at most, delayed. In addition, such a phenomenon can also cause a risk of contamination or siphoning effect, that is, uncontrolled drug application due to the height difference between the drug delivery device and the catheter, which are both connected to line IV.
    [010] In some cases, the user will not even notice that the collar has cracked and is then weakened. Such a situation is particularly problematic when the connector is connected, for example, to a syringe operated by an automatic pump, as for the application of anesthetic product during an operation. The pump is simply a machine that is unable to notice that the collar is cracked or broken and that improper injection occurs. Summary of the Invention
    [011] One aspect of the present invention is to provide an adapter having a collar engaging with the end piece of a drug delivery device, with very limited risk that the collar will break the moment a connector is threaded on it, regardless of variation intensity of force that can be applied by a user to complete the threading connection step.
    [012] A further aspect of the invention is a drug delivery device provided with such an adapter, said adapter being engaged or not engaged with the end piece of the drug delivery device.
    [013] One aspect of the invention is an adapter for a drug delivery device, or intended for use with a drug delivery device having a reservoir for containing a product, the reservoir has a terminal piece projecting distally defining a passage for transferring the product from the reservoir, said adapter comprises: - a collapsible collar with said end piece. - adapter fixing device to limit the translational movement of said collar with respect to said end piece, since said collar is engaged with the end piece, - anti-rotation device of adapter to limit the rotation of said collar with respect to said end piece, since said collar is engaged with the end piece, - deactivation device to neutralize said anti-rotation device of the adapter in response to a turning torque equal to or greater than a predetermined value applied to said collar when the it is even engaged with said end piece, thus allowing the rotation of said collar with respect to said end piece.
    [014] Another aspect of the present invention is a drug delivery device comprising: - a reservoir for containing a product, said reservoir having a terminal piece projecting distally defining a passage for the transfer of the product from the reservoir, - a adapter, such as the adapter above, having a collapsible collar around said end piece, - fixing device to limit the translational movement of said collar with respect to said end piece, since said collar is engaged with said piece terminal, - anti-rotation device to limit the rotation of said collar with respect to said terminal piece, since said collar is engaged around said terminal piece, - deactivation device to neutralize said anti-rotation device in response to a torque of greater than or equal to a predetermined value applied to said co-larinho when it is engaged with said end piece, allowing the thus the rotation of said collar with respect to said end piece.
    [015] The end piece projecting distally may have a longitudinal axis. The fixing device can, in particular, block movement of the collar in the distal direction with respect to the end piece when the collar is engaged with the end piece. The anti-rotation device can, in particular, prevent rotation of the collar with respect to said end piece around said longitudinal axis A under the effect of a turning torque applied to said collar, since said collar is engaged with said end piece.
    [016] In the present invention, since the adapter collar is engaged with the end piece of the drug delivery device, a connector can be threaded into a thread that can be present on an inner wall of the collar without risk the collar to break or even crack. In fact, when a user, who handles the reservoir with one hand and the connector with the other hand, starts to screw the connector on the adapter collar, the collar is kept immobile with respect to the end piece thanks to the anti-rotation device blocking or at least limiting the rotation of the collar around the longitudinal axis of the end piece. As long as the connector has not reached the proximal end of the thread present on the collar, the user feels low resistance from the collar and does not have to apply a high turning torque to the connector in order to thread it on the collar.
    [017] Thanks to the adapter structure of the invention, the user is alerted when the connector has reached the proximal end of the thread present on the collar, for example, by a signal, such as a beep, or a click, as will be clear from from the description below. Therefore, on the one hand, the risks of over-threading and causing the collar to break or crack are avoided, and on the other hand, the end user can easily verify that the connector is mounted correctly and securely attached.
    [018] In fact, in the adapter and the drug application device of the invention, when the connector reaches the proximal end of the collar thread, the user feels resistance from the collar and the turning torque that the user applies to the connector now it tends to cause the collar to rotate. In prior art devices where the collar is permanently attached to the end piece without the possibility of rotating with respect to that end piece, the result is that the collar breaks or splits under the effect of the high turning torque applied by the user via the connector.
    [019] On the contrary, with the adapter of the invention coupled with the end piece of the drug application device of the invention, the deactivation device neutralizes the anti-rotation device, once the user reaches a predetermined value for the turning torque, this that is, the value corresponding to the opposition force felt by the user when the connector is safely threaded. The fact that the collar is then allowed to rotate with respect to the end piece when the user applies a turning torque above said predetermined value prevents the collar from breaking or cracking. Furthermore, when the user sees that the adapter collar rotates with respect to the end piece, he is alerted that the connector is securely and correctly connected to the collar and that the transfer of the product from the reservoir to the IV via the connector can now be carried out without risk.
    [020] Parts of the anti-rotation device may be located on the adapter: they are referred to here as anti-rotation devices on the adapter. Parts of the anti-rotation device may be located on the end piece of the drug delivery device: they are referred to here as anti-rotation device of the end piece. The adapter anti-rotation device and the end piece anti-rotation device can cooperate to form the anti-rotation device.
    [021] In mode, said adapter anti-rotation device comprises a part located in said collar and capable of being engaged in a complementary part located on an external wall of said end piece until said predetermined value of said turning torque is applied to said collar, when said collar is engaged with said end piece. The complementary part can form the anti-rotation device of the end piece.
    [022] In modalities, said anti-rotation device comprises at least one part, located on said collar and at least one complementary part, located on an external wall of said end piece, said part and the complementary part are engaged with each other until said predetermined value of said turning torque is applied to said glue stick, when said collar is engaged with said end piece. In such a situation, said part and said complementary part thus prevent or at least limit the rotation of said collar with respect to said end piece.
    [023] In modalities, said deactivation device is capable of being engaged with the end piece anti-rotation device for a turning torque less than said predetermined value when the collar is engaged with said end piece, said deactivation device deactivation is radially externally flexible under the effect of a turning torque greater than or equal to said predetermined value applied to said collar, said deactivation device thus disengages from said end piece anti-rotation device and allows the collar to rotate with respect to said piece terminal.
    [024] In modalities, said deactivation device is engaged with part of the anti-rotation device, in particular, the anti-rotation device of the end piece, for a turning torque less than said predetermined value when said collar is engaged with said end piece, said deactivation device is radially externally flexible under the effect of a rotating torque greater than or equal to said predetermined value applied to said collar, said deactivation device thus disengages from said part of the anti-rotation device and allows the collar to rotate with respect to said end piece.
    [025] In embodiments, said deactivation device comprises at least one flap piece of said collar, and said end piece anti-rotation device or part of the aforementioned anti-rotation device comprising at least one projection located on an external wall of the said end piece, said flap piece and said projection are releasably interlockable when said collar is engaged with said end piece and until said predetermined value of said turning torque is applied to said collar, the said flap piece radially externally flexible and overlapping said projection when said turning torque is greater than or equal to said predetermined value.
    [026] In modalities, said flap piece is provided with at least one radial wall, said projection leans against said radial wall in order to limit, in cases to prevent the rotation of said collar in relation to said end piece when said collar is engaged with said end piece and until the predetermined value of said turning torque is applied to said collar, said radial wall overlapping said projection under the effect of the external radial deflection of said piece of tab when said turning torque is greater than or equal to said predetermined value.
    [027] In modalities, a plurality of longitudinal ridges is further defined in an internal wall of said flap piece, each longitudinal ridge is freely latchable with said projection in order to limit, in cases in order to prevent the rotation of said collar with respect to said end piece when said collar is engaged with said end piece and until the predetermined value of said turning torque is applied to said collar, and so as to allow rotation of said collar with respect to to said end piece when said turning torque is greater than or equal to said predetermined value.
    [028] In modalities, a plurality of projections is defined and spaced around an external wall of said end piece, said collar is provided with a plurality of flap pieces spaced around the circumference of said collar to match the spacing of said projections. For example, the outer wall of the end piece may be provided with four regularly spaced projections around the circumference of the end piece, and the collar may be provided with four flap pieces regularly spaced around the circumference of the collar.
    [029] In the adapter and drug delivery device of the invention, parts of the fixation device can be located on the adapter: they are referred to here as adapter fixation devices. Parts of the clamping device can be located on the end piece: they are referred to as end piece clamping devices here. The adapter clamping device and the end piece clamping device can cooperate to form the clamping device. In embodiments, an annular crest is provided on an external wall of the end piece, said adapter fixing device comprises a support surface provided on the inner wall of the collar, said support surface is in engagement with said annular crest when the said collar is propelled in the distal direction, since it is engaged with said end piece.
    [030] In embodiments, said fixing device comprises an annular crest provided on the outer wall of the end piece and a support surface provided on the inner wall of the collar, said support surface is in engagement with said annular crest when said collar is moved in the distal direction, since it is engaged around said end piece.
    [031] In modalities, said support surface is an annular ring provided on the inner wall of said flap piece. In embodiments, said support surface is formed from the distal ends of said longitudinal ridges.
    [032] In modalities, said collar has a defined thread on an internal surface of a distal wall. As will be clear from the description below, this thread is intended to cooperate with the complementary thread of a connector intended to be connected to said collar.
    [033] In modalities, said distal wall of said collar is formed from a material selected from olefins, polyamide, polycarbonate, polyetherketone and combinations thereof. Olefins can be selected from polyolefins or cycloolefins, such as cycloolefin polymers and cycloolefin copolymers. Such material ensures good rigidity to the distal wall of the collar, where the thread is present and where the threading of the connector will take place. Alternatively or in combination, the adapter may further comprise a reinforcement device defined on an external surface of a distal wall of said collar. The reinforcement device may be additional outer crystals of material added to the outer surface of the distal collar wall.
    [034] In modalities, said deactivation devices are made of a material selected from olefins, polyamide, polycarbonate, thermoplastic elastomer, polyoxymethylene, polybutylene terephthalate, styrenic polymers, polyvinyl chloride, acrylonitrile butadiene styrene and combinations of these . Olefins can be selected from polyolefins or cycloolefins, such as cycloolefin polymers and cycloolefin copolymers.
    [035] In modalities, the said end piece is made of glass.
    [036] In other modalities, said terminal piece is made of plastic.
    [037] In embodiments, the adapter may further comprise adapter guide devices to ensure the alignment of said collar on said end piece when said collar is being engaged with the end piece. In particular, the adapter guide devices can ensure the alignment of said collar on the longitudinal axis of the end piece in cooperation with the end piece guide devices located on the end piece, said adapter guide devices and the end piece guide devices forming the guiding device of the drug delivery device together.
    [038] In embodiments, said radial wall (s) of said flap piece form at least part of said adapter guide devices. Said adapter guide devices may further comprise longitudinal grooves formed by the interspaces present between the longitudinal ridges.
    [039] In modalities, the drug delivery device also comprises guide devices to ensure the alignment of said collar on said end piece, in particular, on the longitudinal axis of said end piece, when said collar is being engaged with said end piece.
    [040] Said guiding devices may comprise said projection (s), in particular, as guiding devices of end piece, and said radial wall (s) of said flap piece, said projection (s) sliding along along said radial wall (s) when said collar is being engaged with said end piece. Said guide devices may further comprise longitudinal grooves defined by interspaces present between the longitudinal ridges, each of said projections engaging within one of said longitudinal grooves when said collar is being engaged with said end piece.
    [041] In modalities, said guide devices also comprise chamfered surfaces of said longitudinal ridges, said chamfered surfaces driving said projections in said longitudinal grooves when said collar is being engaged with said end piece.
    [042] Another aspect of the invention is a drug delivery device comprising a reservoir to contain a product, said reservoir has a terminal piece protruding distally, as described above, and defining a passage for the transfer of the product from the reservoir, and an adapter, as described above, engagable with said end piece. Another aspect of the invention is an assembly comprising a drug delivery device, as described above, and an adapter, as described above, engageable with the end piece of said drug delivery device. Brief Description of Drawings
    [043] The adapter and drug delivery device of the invention will now be described with reference to the following description and attached drawings in which:
    [044] FIG. 1 is a perspective view of a first embodiment of the adapter and drug delivery device of the invention, before engaging the adapter with the end piece.
    [045] FIG. 2 is a perspective view of the device of FIG. 1 since the adapter co-larinho is engaged in the reservoir end piece.
    [046] FIG. 3 is a partial side view of the reservoir of the drug delivery device of FIG. 1.
    [047] FIG. 4 is a partial cross-sectional view of the reservoir of FIG. 3.
    [048] FIG. 5 is a cross-sectional view of the adapter of FIG. 1.
    [049] FIG. 6 is a top view of the adapter of FIG. 5.
    [050] FIG. 7 is another perspective view of the adapter of FIG. 1.
    [051] FIG. 8 is a cross-sectional view of the perspective view of FIG. 7.
    [052] FIG. 9 is a cross-sectional view of the drug delivery device of FIG. 2 with the adapter engaged with it.
    [053] FIG. 10 is a cross-sectional view along the IT piano of FIG. 9.
    [054] FIG. 11 is a cross-sectional view of the drug delivery device of FIG. 10, since the turning torque was applied to the collar.
    [055] FIG. 12 is a perspective view of a second embodiment of the adapter of the invention.
    [056] FIG. 13 is a cross-sectional view of another embodiment of the adapter of the invention.
    [057] FIG. 14 is a top view of the adapter of FIG. 13.
    [058] FIG. 15 is a perspective view of the adapter of FIG. 13.
    [059] FIG. 16 is a cross-sectional view of the adapter of FIG. 13 engaged with the end piece of the drug delivery device of FIGs. 1 to 12. Detailed Description of the Invention
    [060] With respect to FIG. 1, a drug delivery device 1 and an adapter 100 according to the invention are shown, the drug delivery device 1 comprises a reservoir 20 (partially shown) and the adapter 100 comprises a collar 30.
    [061] Reservoir 20 is intended to receive a product, preferably a fluid such as a liquid medicine, intended to be injected into a patient. The reservoir 20 then has the general shape of a container, for example, the reservoir can be a vial or a syringe body. The reservoir 20 is provided with an end piece 21 projecting distally from a distal wall 20a of the reservoir 20. The end piece 21 has a longitudinal axis A and defines a channel 22 providing a passage for the transfer of the product from the reservoir. 20.
    [062] The end piece 21 can be made of any material commonly used to manufacture medical containers such as vials or syringes. For example, the end piece 21 can be made of glass, in particular, when the reservoir is a glass syringe. Alternatively, the end piece can be made of plastic material. The end piece and the reservoir walls can be of different materials.
    [063] With respect to FIGs. 1, 3 and 4, the end piece 21 has the overall shape of a part of a hollow cone. The end piece 21 is provided on its outer wall with an annular ridge 23, located substantially in an intermediate region of said end piece 21. With reference to FIG. 4, the annular ridge 23 is provided with an inclined distal face 23a and a radial proximal face 23b. The outer wall of the end piece 21 is also provided with four longitudinal projections 24 evenly spaced around the circumference of the end piece 21 and proximally spaced with respect to the annular crest 23.
    [064] With respect to FIGs. 1 and 5 to 8, the collar 30 of the adapter 100 will now be described in more detail. As will be clear from the description below, collar 30 is interlockable around end piece 21. In the example shown, collar 30 is globally elongated in shape and comprises a proximal region 30a and distal region 30b.
    [065] The distal region 30b of the collar 30 is globally in the form of a tubular part and is provided on its internal wall with a thread 31, the function of which will be explained later. Thread 31 has a proximal end 31a and a distal end 31b. The distal region 30b of the collar 30 can be made of a material that shows a certain stiffness. In an embodiment shown in FIG. 12, the outer wall of the distal region 30b is provided with reinforcement devices in the form of external ridges 34. Such external ridges 34 improve the stiffness of the distal region 30b. As will be clear from the description below, the distal region 30b of the collar 30 is the one that is subjected to tension when a connector 40 (see FIG. 2) is connected to adapter 100: the material forming this distal region and the optional reinforcement devices, as described above, provide good rigidity to that distal region.
    [066] In the example shown in FIGs. 5 and 7, the proximal region 30a of the collar 30 comprises four flap pieces 32 extending proximally from the proximal end of the distal region 30b. In the example shown, the four flap pieces 32 are regularly spaced around the circumference of the collar 30 and they are separated from each other by four longitudinal slits 33. As will be clear from the description below, the flap pieces 32 are flexible and capable to be radially externally flexible under the effect of an externally radial force exerted on its inner wall 32a. In addition, each flap piece 32 has two side faces forming radial walls 32b.
    [067] In other modalities not shown, the proximal region of the collar could comprise only one flap, or alternatively two, three or five or more flap pieces, as long as that flap or flap pieces are radially externally flexed.
    [068] As such, the flap or flap pieces 32 of the proximal region of the collar 30 can be made of any material having sufficient elasticity to allow the flap or flap pieces to be flexed as explained above. For example, such a material can be selected from olefins, such as polyolefins or cycloolefins, in particular cycloolefin polymers and copolymers of cycloolefin, polyamide or nylon, polycarbonate, thermoplastic elasomer, polyoxymethylene , polybutylene terephthalate, styrenic polymers, polyvinyl chloride, acrylonitrile butadiene styrene, and combinations thereof.
    [069] With respect to FIGs. 7 and 8, each flap piece 32 is provided on its inner wall 32a with a plurality of substantially parallel longitudinal ridges 35. The distal ends of these longitudinal ridges 35 together form a supporting surface 36.
    [070] With respect to FIG. 6, the plurality of longitudinal ridges 35 defines a plurality of longitudinal grooves 37 located between them. In addition, each longitudinal crest 35 is provided with chamfered surfaces 35a in the direction of the longitudinal axis B of the collar 30.
    [071] As will be clear from the description below, the adapter 100 of the invention is particularly useful for connecting a connector to the end piece 21 of the drug delivery device 1 with very limited risk of damaging the collar 30. In any case, before to connect a connector to the drug delivery device 1, the user needs to engage the collar 30 on the end piece 21. The engagement of the collar 30 of the adapter 100 of the invention to the end piece 21 of the drug delivery device 1 of the invention will now be described with reference to FIGs. 1,2 and 9.
    [072] Generally, the user is provided with the drug delivery device 1 and the adapter 100 prior to engaging the collar 30 on the end piece 21, as shown in FIG. 1. The user then holds the reservoir 20 in one hand and the collar 30 in the other hand and approaches the proximal region 30a towards the distal end of the end piece 21 along the direction of the longitudinal axis A. The inner wall 32a of the pieces flap 32 from the proximal region 30a of the collar 30 slides along the outer wall of the end piece 21 until it reaches the inclined face 23a of the annular ridge 23 of the end piece 21. Thanks to the ability of the flap pieces 32 to be radially and externally flexed , the flap pieces 32 flex in the external direction, overlap the annular crest 23 and return to their resting state, in which they are facing the longitudinal projections 24 of the proximal region of the flap piece 21.
    [073] In that position, as shown in FIGs. 2 and 9, the collar 30, and thus the adapter 100, is securely engaged with the flap piece 21. The collar 30, and thus the adapter 100, is blocked, or at least limited, in translation with respect to the longitudinal axis Both in the proximal direction, by virtue of the proximal end of the collar 30 against the distal wall 20a of the reservoir 20, and in the distal direction, by virtue of the support surface 36 in contact with the radial proximal face 23b of the annular crest 23 of the end piece 21. As such, the support surface 36 and the radial proximal face 23b of the annular ridge 23 form the fixing device to block or at least limit the translational movement of the collar 30, in particular, in the distal direction, with respect to the part terminal 21 when said collar 30 is engaged with said terminal piece 21. The support surface 36 forms the adapter clamping device, the radial proximal face 23b of the annular ridge 23 forming the clamping device of the end piece.
    [074] Furthermore, in the position of the drug delivery device 1 shown in FIGs. 2 and 9, where collar 30 is engaged with end piece 21, and in the absence of significant turning torque applied to collar 30, as will be described later, collar 30, and thus adapter 100, is still locked or less limited in rotation with respect to the end piece 21, due to the longitudinal projections 24 engaged in the longitudinal grooves 37 or in the longitudinal slits 33, as shown in FIG. 10. In fact, during the step of engaging the collar 30 on the end piece 21, the longitudinal projections 24 of the end piece 21 come into contact with the longitudinal ridges 35 of the flap pieces 32 or with the radial walls 32b of the flap pieces 32 : during the proximal movement of the collar 30 with respect to the end piece 21, the chamfered surfaces 35a of the longitudinal ridges 35 force the longitudinal projections 24 towards the longitudinal grooves 37 and / or the radial walls 32b of the flap pieces 32 come into contact with the longitudinal projections 24, forcing these longitudinal projections 24 into the slits 33: the chamfered surfaces 35a and / or the radial walls 32b of the flap parts 32 act as adapter guide devices to correctly align the collar 30 on the end piece 21 along the axis longitudinal A. The longitudinal projections 24 act as guide devices for the end piece. The longitudinal projections 24 and the chamfered surfaces 35a and / or the radial walls 32b of the flap parts 32 act together as guide devices to ensure the alignment of the collar 30 in the end piece when the collar is being engaged with the end piece 21.
    [075] Furthermore, the longitudinal projections 24 on the one hand, and the radial walls 32b and the longitudinal ridges 35 on the other hand, also act as anti-rotation devices to prevent the rotation of the collar 30 with respect to the end piece 21 about the longitudinal axis -dinal A under the effect of a turning torque applied to said collar 30. The longitudinal projections 24 act as anti-rotation devices of the end piece and the radial walls 32b and the longitudinal ridges 35 act as anti-rotation devices of the adapter.
    [076] The adapter 100 of the invention, however, allows the deactivation of such anti-rotation devices, since the turning torque applied to the collar 30 reaches a predetermined value probably to cause the collar 30 to break or crack under force that it is subjected when a connector is threaded on it.
    [077] The behavior of the collar 30 of the adapter 100 of the invention, once engaged with the end piece 21 and when the connector is threaded on it will now be described with reference to FIGs. 2 and 9 to 11.
    [078] With respect to FIG. 2, the drug delivery device 1 of the invention is shown, with the collar 30 of the adapter 100 engaged with the end piece 21, and a connector 40 intended to be connected to the end piece 21 of the drug delivery device 1.
    [079] As explained above, handling liquid medication for parental administration to a patient that is performed via an infusion device, as often in hospitals or in emergency situations, implies the use of IV line that need connected to drug delivery devices. With reference to FIG. 2, the connector 40 comprises an IV line 41, the distal end of which (not shown) is connected to a patient's vein (not shown). The connector 40 is provided at its proximal end with a thread 42 designed to cooperate with the thread 31 of the collar 30 in order to securely connect the connector 40 to the drug delivery device 1, and, consequently, securely connect the line IV 41 to the terminal piece 21, thus enabling the transfer of the product from the reservoir 20 to the patient's vein.
    [080] During the treatment of a patient, or during an operation if the product is an anesthetic product, the product needs to be applied to the patient or on a continuous basis and, once the reservoir of a drug delivery device is emptied , another drug delivery device 1 with a full reservoir needs to be connected to line IV 41 via connector 40.
    [081] To proceed to this connection step, the user holds the drug delivery device 1 with the collar 30 of the adapter 100 engaged with the end piece 21 in one hand, as shown in FIG. 2, and in the other hand, the connector 40. The user approaches the proximal end 42a of the thread 42 of the connector 40 to the distal end 31b of the thread 31 of the collar 30 and begins to thread the connector 40 into the collar 30.
    [082] During this threading step, as long as the connector 40 is not completely threaded on the collar 30, the turning torque applied by the user on the connector 40 and casually on the collar 30 by the action of screwing the connector 40 on it is low and the projections longitudinal ridges 24 of the end piece 21 cooperate with the longitudinal ridges 35 of the flap pieces 32 of the collar 30, in order to act as anti-rotation devices and to prevent rotation of the collar 30 with respect to the end piece 21, as shown in FIG. 10. Threading is then facilitated.
    [083] The turning torque applied by the user to connector 40 in order to thread it on collar 30 is transferred to the collar when connector 40 is completely threaded on collar 30: this can happen, for example, or when the proximal end 42a of thread 42 of connector 40 abuts the proximal end 31a of thread 31 of collar 30, or when a proximal surface of connector 40 abuts the distal surface of collar 30, or when sufficient frictional forces between thread 42 of connector 40 and the thread 31 of the collar 30 are formed. When the turning torque thus transferred to the collar 30 reaches a predetermined value, the collar 30 is driven to rotate with respect to the end piece 21.
    [084] In prior art devices, when the collar is, for example, permanently fixed with respect to the end piece, the collar may not absorb this additional turning torque and is caused to break or crack.
    [085] In contrast, in the drug delivery device 1 and the adapter 100 of the invention, when the turning torque transferred to the collar 30 reaches a predetermined value, for example, a value of 50 N.cm, the parts flexible flap 32 are caused to flex radially outward and then act as anti-rotation device deactivation devices, thus enabling collar 30 to rotate and prevent collar 30 from cracking and / or breaking.
    [086] With respect to FIG. 10, as long as the turning torque transferred to the collar 30, as explained above, is less than a predetermined value, the longitudinal projections 24 are engaged in the longitudinal grooves 37 defined by the longitudinal ridges 35 of the flexible flap parts 32 and are leaning against the chamfered surfaces 35a of said longitudinal ridges 35.
    [087] With respect to FIG. 11, when the turning torque, shown as R in the figure, transferred to the collar 30 is greater than or equal to a predetermined value, the longitudinal projections 24 slide on the beveled surfaces 35a and cause the flap pieces 32 to bend radially to out in the direction of the arrows called F in FIG. 11. The longitudinal projections 24 overlap the longitudinal ridges 35 and are engaged in the adjacent longitudinal groove 37, thus maintaining the correct axial alignment of the collar 30 on the end piece 21.
    [088] The deflection of the flap pieces 32 not only prevents the break and / or cracking of the collar 30, but also informs the user of the fact that the connector 40 is completely threaded inside the collar 30 and that the line IV 41 is securely connected to the end piece 21 of the drug delivery device 1. For example, the user may be alerted by a click or sound produced by a projection 24 when it leans against the adjacent longitudinal ridge 35 after it overlaps the longitudinal ridge previous 35.
    [089] With respect to FIGs. 13 to 16, another embodiment of the adapter 100 of the invention is shown for which the collar 130 is provided with four flexible flap pieces 132 free of longitudinal ridges on its inner walls 132a. The collar 130 of FIGs. 13 to 16 can be used with the same drug delivery device 1 and end piece 21 of FIGs. 1 to 11. In such an embodiment of the adapter 100, the anti-rotation devices of the adapter comprise the radial walls 132a formed by the side faces of the flap pieces 132.
    [090] As shown in FIGs. 14 and 15, the four flap pieces 132 are spaced around the longitudinal axis B of the collar 130 and they are separated from each other by longitudinal slits 133. When the collar 130 is engaged with the end piece 21 of the drug delivery device 1 , as shown in FIG. 16, the projections 24 of the end piece 21 are forced into the longitudinal slots 133 by the radial walls 132b acting as adapter guide devices. Once the collar 130 is engaged with the end piece 21, the projections 24 are abutted against the radial walls 132b, provided that the turning torque applied to the collar 130 is less than the predetermined value, as defined above. The radial walls 132b form the adapter anti-rotation device.
    [091] As the flap pieces 132 are radially flexed outward, when a turning torque greater than or equal to said predetermined value is applied to said collar 130, flap pieces 132 flex radially outward and overlap the resistance of the projections 24 , thus allowing the rotation of the collar 130 with respect to the end piece 21, as previously described for the embodiment of FIGs. 1 to 11.
    [092] As the embodiment of FIGs. 1 to 11, the collar 130 of FIGs. 13 to 16 is provided with an annular ring 136 intended to rest against the proximal face 23b of the annular ridge 23 of the end piece when the collar 130 is engaged with the end piece 21.
    [093] The predetermined value, as described above, for the turning torque is a function of the size and structure of the collar and the materials forming the collar, in particular, its flexible elements, and the end piece.
    [094] For example, for an end piece made of a thermoplastic material selected from olefins, in particular polyolefins and cycloolefins, for example, cycloolefins polymers and cycloolefins copolymers, polyamide, or nylon, polycarbonate and such combinations and a collar as described in FIGs. 1 to 11, for which the flap parts are made of a thermoplastic material selected from olefins, polyamide, polycarbonate, thermoplastic elastomer, polyoxymethylene, polybutylene terephthalate, styrenic polymers, polyvinyl chloride, acrylonitrile butadiene styrene, and combinations of these, the default value for the turning torque is 50 N.cm.
    [095] The adapter and the drug delivery device of the invention allow the secure connection of an IV line connector to the end piece of said device without risk of the collar of said device breaking or cracking, regardless of the force applied to the co-device. connector to connect it to the device.
    权利要求:
    Claims (15)
    [0001]
    1. Adapter (100) intended for use with a drug delivery device (1) having a reservoir (20) to hold a product, the reservoir has a terminal piece projecting distally (21) defining a passage (22 ) for transferring the product from the reservoir, comprising: a collar (30, 130) engageable with said end piece; adapter fixing device (36) to limit the translational movement of said collar with respect to said end piece, since said collar is engaged with the end piece, FEATURED by the fact that it comprises: adapter anti-rotation device (32b, 35, 132b) to limit the rotation of said collar with respect to said end piece, since said collar is engaged with the end piece; deactivation device (32, 132) to neutralize said anti-rotation device of the adapter in response to a turning torque greater or equal to a predetermined value applied to said collar when it is engaged with said end piece, thus allowing rotation of the said collar with respect to said end piece.
    [0002]
    2. Adapter (100), according to claim 1, CHARACTERIZED by the fact that the adapter anti-rotation device comprises a part (32b, 35, 132b) located in said collar and capable of being engaged in a complementary part located in a external wall of said end piece until said predetermined value of said turning torque is applied to said collar, when it is engaged with said end piece.
    [0003]
    3. Adapter (100), according to claim 1 or 2, CHARACTERIZED by the fact that said deactivation device is capable of being engaged with the end piece anti-rotation device (24) for a lower turning torque than that said predetermined value when the collar is engaged with said end piece, said deactivation device (32, 132) is radially externally flexed under the effect of a turning torque greater than or equal to said predetermined value applied to said collar, said deactivation device thus disengages from said end piece anti-rotation device (24) and allows the collar to rotate with respect to said end piece.
    [0004]
    4. Adapter (100) according to claim 3, CHARACTERIZED by the fact that said deactivation device comprises at least one flap piece (32, 132) of said collar, and wherein said anti-rotation device of end piece comprises at least one projection (24) located on an external wall of said end piece, said flap piece (32, 132) and said projection (24) being releasably interlockable when said collar is engaged with the said end piece and until said predetermined value of said turning torque is applied to said collar, said flap piece (32, 132) radially externally flexed and overlapping said projection when said turning torque is greater than or equal to said predetermined value.
    [0005]
    5. Adapter (100), according to claim 4, CHARACTERIZED by the fact that said flap piece (32, 132) is provided with at least one radial wall (32b, 132b), said projection (24) slope against said radial wall (32b, 132b) in order to limit the rotation of said collar with respect to said end piece when said collar is engaged with said end piece and until the predetermined value of said turning torque is applied to said collar, said radial wall (32b, 132b) overlapping said projection (24) under the effect of the external radial flexion of said flap piece (32, 132) when said turning torque is greater than or equal to said predetermined value.
    [0006]
    6. Adapter (100), according to claim 5, further characterized by the fact that it comprises a plurality of longitudinal ridges (35) defined in an internal wall (32a) of said flap piece (32), each crest longitudinal (35) is releasably engagable with said projection (24) in order to limit the rotation of said collar with respect to said end piece when said collar is engaged with said end piece and until the predetermined value of said turning torque is applied to said collar, and in order to allow rotation of said collar with respect to said end piece when said turning torque is greater than or equal to said predetermined value.
    [0007]
    Adapter (100) according to any one of claims 4 to 6, CHARACTERIZED by the fact that a plurality of projections (24) is defined and spaced around an external wall of said end piece (21), said collar (30, 130) is provided with a plurality of flap pieces (32, 132) spaced around the circumference of said collar to match the spacing of said projections.
    [0008]
    Adapter (100) according to any one of claims 1 to 7, CHARACTERIZED by the fact that an annular ridge (23) is provided on an external wall of the end piece (21), said adapter fixing device comprises a support surface (36, 136) provided on the inner wall of the collar (30, 130), said support surface (36, 136) being engaged with said annular crest (23, 23b) when said collar is driven in the distal direction, since it is engaged with said end piece.
    [0009]
    9. Adapter (100) according to any one of claims 4 to 8, CHARACTERIZED by the fact that said support surface is an annular ring (36, 136) provided on the inner wall (32a, 132a) of the (s) said flap piece (s) (32, 132).
    [0010]
    An adapter (100) according to any one of claims 1 to 9, CHARACTERIZED by the fact that said collar (30, 130) has a thread (31, 131) defined on an internal surface of a distal wall (30b , 130b).
    [0011]
    11. Adapter (100) according to claim 10, CHARACTERIZED by the fact that it further comprises reinforcement devices (34) defined on an external surface of said distal wall (30b) of said collar.
    [0012]
    Adapter (100) according to any one of claims 1 to 11, CHARACTERIZED in that it further comprises adapter guide devices (37, 35a) to ensure the alignment of said collar on said end piece when said collar is being engaged with the end piece.
    [0013]
    13. Adapter (100), according to claims 5 and 12, CHARACTERIZED by the fact that said radial wall (s) (32b, 132b) of said flap piece (s) (32, 132) form at least part of said adapter guide devices.
    [0014]
    14. Adapter (100) according to claims 6 and 13, CHARACTERIZED by the fact that said adapter guide devices additionally comprise longitudinal grooves (37) formed by the interspaces present between the longitudinal ridges (35).
    [0015]
    15. Drug delivery device (1) including the adapter (100) as defined in claim 1, CHARACTERIZED by the fact that it comprises: a reservoir (20) for containing a product, said reservoir having an end piece projecting distally ( 21) defining a passage (22) for the transfer of the product from the reservoir, fixing device (23, 36, 136) to limit the translational movement of said collar with respect to said end piece, since said collar is engaged with said end piece, anti-rotation device (24, 32b, 35, 132b) to limit the rotation of said collar with respect to said end piece, since said collar is engaged with said end piece, deactivation device ( 32, 132) to neutralize said anti-rotation device in response to a turning torque greater than or equal to a predetermined value applied to said collar when it is engaged with said end piece, thus allowing the rotation of said collar with respect to said end piece
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-07-30| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-03-31| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|
    2020-08-04| B09A| Decision: intention to grant|
    2020-10-13| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 16/12/2010, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    PCT/IB2010/003493|WO2012049532A1|2010-12-16|2010-12-16|Adaptor and drug delivery device|
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