The present invention relates to a drug delivery device and an adaptor for, or intended to be used with said drug delivery device. The drug delivery device is provided with an end-piece around which the adaptor is engageable so as to enable the safe connection of a connector on said end-piece.
Drug delivery devices usually comprise a hollow body forming a reservoir for containing a medical product. In addition, the distal end of the body forming the reservoir usually comprises an end-piece in which an axial passageway is arranged through which the said product is ejected from the reservoir.
In this disclosure, the distal end of a component or of a device must be understood as meaning the end furthest from the hand of the user and the proximal end must be understood as meaning the end closest to the hand of the user. Similarly, in this disclosure, the distal direction must be understood as the direction of injection or transfer of the product (i.e. from the reservoir to the Intra Veinous line) and the proximal direction is the opposite direction.
The handling of products, such as liquid medicine, in particular for a parenteral administration to a patient which is carried out via a perfusion device, as often in hospitals or in emergency situations, implies, in a general manner, the use of connectors, such as IV (Intra Veinous) connectors which link the drug delivery device, containing the product to be delivered, to the vein of the patient, usually via an IV line. Of course, the drug delivery device, in particular its end-piece and the connector must be assembled together correctly and securely.
Actually, there are different connection systems for connecting a connector to the end-piece of a drug delivery device, when the distal portion of said end-piece has the global shape of a distally tapered cone, also called a male Luer, as is usually the case.
In such cases, the male luer of the end-piece forming the male part of the connection system, the connector usually comprises a corresponding conical bore forming the female part of the connection system, also called a female luer, and intended to be fitted on the male luer in order to complete the connection.
In some cases, no additional element is provided on the connector, and the female luer is directly fitted on the male luer of the end-piece of the drug delivery device by simple force fitting: the connector is then called a luer slip connector and the connection is called a luer slip connection.
Alternatively, the connection system may comprise in addition an adaptor, said adaptor being fixed to the end-piece of the drug delivery device via a collar, and comprising a tubular wall at least partially surrounding the male luer of the end-piece. The tubular wall is provided with an inner thread intended to cooperate with a corresponding outer thread located on an outer wall of the connector provided with the female luer. In such a case, at the time of forming the connection, the female luer is fitted onto the male luer by means of threading the connector in the adaptor: the safe connection of the male luer and female luer is therefore improved. Such an adaptor is called a luer Lock Adaptor, the connector is called a luer Lock connector and the connection thus realized is called a luer lock connection. Alternatively, the threads may be replaced by cooperating wings.
It derives from these two connection systems that all the connectors may not have the same shapes: the connectors to be used for a luer Lock connection will comprise an outer thread (or a wing), whereas the connectors to be used for a luer slip connection will not. Indeed, if a luer slip connector is brought close to the distal portion of the end-piece of a drug delivery device provided with a luer Lock adaptor as described above, the luer Lock adaptor will be an obstacle to the female luer of the luer slip connector and will prevent the completion of a safe connection between the drug delivery device and the connector.
One aspect of the invention is to provide an adaptor engageable with the end-piece of a drug delivery device, in particular where the end-piece has a distal portion having a distally tapered cone shape such as a male luer, said adaptor being capable of easily changing positions so as to allow both types of connections, luer slip and luer lock, as described above, depending on which type of connector is provided, with no particular effort from the user. In particular, one aspect of the invention is to provide an adaptor engageable on the end-piece of a drug delivery device and allowing successive connections of various connector types, in particular luer lock and luer slip types, with no need for the user to reconfigure the drug delivery device between two connections, regardless of the type of the selected connector. With such an adaptor, the connection is completed whatever the connectors used with no additional action required from the user. The user just has to position the connector to the end-piece of the drug delivery device and the connection, either luer lock or luer slip, is automatically completed due to the possibility of the adaptor to adopt different configurations.
Another aspect of the invention is to provide an adaptor capable of coming back to its initial position after removal of the connector.
An aspect of the invention is a drug delivery device comprising:
a reservoir for containing a product, said reservoir having a distally projecting end-piece having a longitudinal axis and defining an axial passageway for the transfer of the product from the reservoir, said end-piece having a distal portion,
an adaptor having a collar engageable around said end-piece so that said collar is axially movable with respect to said end-piece,
securing means for limiting the axial movement of said collar with respect to said end-piece once said collar is engaged around said end-piece, between a most distal position of said collar, in which a first length of said distal portion is left uncovered by said adaptor, and a most proximal position of said collar, in which a second length of said distal portion, greater than said first portion, is left uncovered by said adaptor,
biasing means for urging said collar towards its most distal position.
As will be clear from the following description, the collar of the adaptor of the drug delivery device of the invention is easily movable along the end-piece between its most proximal position, in which the length of the distal portion of the end-piece, in particular a male luer, left uncovered, in other words the second length, allows a luer slip connection to be completed, and its most distal position, in which the length of the distal portion left uncovered, in other words the first length, allows the adaptor to cooperate with the luer Lock connector in order to complete a luer lock connection. Indeed, when the collar is in its most proximal position, the length of the distal portion of the end-piece that is left uncovered allows a luer slip connector to be easily fitted on said distal portion, the adaptor forming no obstacle to this connection: the user needs only apply a proximal pressure to the biasing means, so as to put them in a stressed state, thereby pushing the collar in its proximal position, in order to connect the luer slip connector onto the distal portion of the end-piece.
Alternatively, if a luer lock connection is needed, the user does not need to apply a proximal pressure on the adaptor, as the presence of the biasing means automatically maintain the collar of the adaptor in its most distal position. The luer lock connection can therefore be simply completed by simply connecting the luer Lock connector to the adaptor, for example by threading, thereby completing a safe connection between the female luer and the distal portion of the end-piece.
In addition, thanks to the drug delivery device and adaptor of the invention, a user can simply change connectors without having to reconfigure the drug delivery device between two connections, regardless of the type of connector used. For example, if a luer slip connector is connected on the distal portion of the end-piece of the drug delivery device of the invention and the user wishes to replace it by a luer Lock connector, he simply needs to remove the luer slip connector. Thanks to the biasing means of the drug delivery device of the invention, the collar will automatically come back to its most distal position when the luer slip connector is removed, and the user may simply connect the luer Lock connector to the adaptor.
In embodiments, said securing means comprises proximal locking means for preventing said collar from moving beyond its most proximal position and distal locking means for preventing said collar from moving beyond its most distal position. For example, said proximal locking means comprise a transversal wall of said reservoir. The distal locking means may comprise an annular ridge provided on an outer wall of said end-piece and an abutment surface provided on an inner wall of said collar, said abutment surface coming in engagement onto said annular ridge when said collar is urged in the distal direction once it is engaged around said end-piece.
In embodiments, said biasing means comprise one or more flexible legs extending from said collar in the proximal direction, said flexible legs being in a first stressed state when said collar is in its most proximal position, said flexible legs being in a second stressed state when said collar is in its most distal position, said second stressed state being a state of lower stress than said first stressed state. In embodiments, the stress applied to the flexible legs in their second stressed state may tend to zero.
In embodiments, the drug delivery device may further comprise protection means for preventing access to the biasing means by a user. For example, said protection means comprise a proximal tubular wall extending from said collar in the proximal direction and surrounding said flexible legs. Such a proximal tubular wall prevents that the biasing means, for example the flexible legs, be damaged.
In embodiments, the drug delivery device comprises anti-rotation means for limiting the rotation of said collar with respect to the end-piece once said collar is engaged with said end-piece. Said anti-rotation means may comprise one or more longitudinal ridge located on an outer wall of said end-piece, and one or more recess located on an inner wall of said collar, said longitudinal ridge being engaged into said recess and thereby preventing said collar to rotate with respect to said end-piece. Such anti-rotation means allow a safe threading of the luer Lock connector into the adaptor, as the adaptor is maintained locked in rotation with respect to the end-piece when the luer Lock connector is threaded therein.
In embodiments, the adaptor further comprises a distal tubular wall extending from said collar in the distal direction and surrounding at least part of said distal portion of said end-piece when said collar is engaged around said end-piece, said tubular wall being provided on its inner wall with a thread. Said thread is preferably arranged so as to cooperate with the complementary thread located on a luer lock connector to be connected to the end-piece of the reservoir.
In embodiments, said flexible legs are made of a material selected from olefins, polyimide, polycarbonate, polyetherketone and combinations thereof.
In embodiments, said end-piece is made of glass. Alternatively, said end-piece may be made of plastic.
In embodiments, said distal portion is a male luer, in other words is a distally tapered cone.
Another aspect of the present invention is an adaptor as described above, having a collar arranged for cooperating with a reservoir having a distally projecting end-piece having a longitudinal axis and defining an axial passageway for the transfer of the product from the reservoir, for forming a drug delivery device as described herein.
The drug delivery device and adaptor of the invention will now be further described in reference to the following description and attached drawings in which:
With reference to
The reservoir 10 is intended to contain a product to be delivered to a patient. The reservoir 10 may be formed of any material suitable for storing a product such as a medicine or drug. It may be made out of glass or plastic materials. On the example shown, the reservoir 10 has the global shape of a syringe body and comprises a tubular barrel 11, open at its proximal end 11a where it is provided with an outer flange 12 intended to form a pushing surface for the user at the time of delivery of the product to a patient.
At its distal end 11b, the tubular barrel 11 is substantially closed by a transversal wall 13, except for a central opening 14 (see
With reference to
With reference to
As appears from
With reference to
As shown on
With reference to
With reference to
The operation of the adaptor 30 and the drug delivery device 100 will now be explained with reference to
In the second stressed state of the helicoidal flexible legs 34, i.e. in their state of lower stress, the collar 31 is in a most distal position, as shown on
As shown on
In this position as shown on
In the luer Lock connection position of the drug delivery device as shown on
Nevertheless, thanks to the adaptor 30 of the invention, if the user wishes to perform a luer slip connection, he just needs to push the adaptor 30 in the proximal direction, for example by the intermediate of a luer slip connector 90 as shown on
As shown on
Moreover, thanks to the helicoidal flexible legs forming biasing means for urging the collar 31 in its most distal position, the drug delivery device 100 may come back in its luer lock connection position easily, as soon as the user removes the luer slip connector 90 and releases the proximal pressure he exerts on the adaptor 30. The drug delivery device 100 of the invention is therefore particularly easy to use and to reuse subsequently for any type of connector. For instance, in a case where the reservoir is to be connected successively to more than one connector, for example because successive portions of the product contained in the reservoir are to be transferred to various lines or patients, the user has no additional step to perform on the drug delivery device in order to replace a luer slip connector by a luer lock connector: if a luer slip connector was connected to the end-piece 20 in the first place and the drug delivery device 100 was in its luer slip connection position as shown on
The drug delivery device of the invention and its adaptor therefore allow quick, simple, and numerous changes of connectors, regardless of the types of these connectors. It allows safe connections and allows time-saving.
With reference to
On
In addition, thanks to the biasing properties of the bending legs 39, the drug delivery device 100 is capable of coming back automatically to its luer lock connection position, as soon as the proximal pressure exerted on the adaptor is released, for example, when the luer slip connector is removed in view of changing connectors.
With reference to
With reference to
In the second stressed state, or low stress state, of the plurality of collapsible legs 70, as shown on
The drug delivery device and the adaptor of the invention therefore allow changing connectors easily, quickly, and with no need for the user to reconfigure the drug delivery device between two successive connections, regardless of the type of connector that is used, in particular a luer lock connector or a luer slip connector.
Number | Date | Country | Kind |
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11305927 | Jul 2011 | EP | regional |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/EP2012/063827 | 7/13/2012 | WO | 00 | 1/14/2014 |
Publishing Document | Publishing Date | Country | Kind |
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WO2013/010951 | 1/24/2013 | WO | A |
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Number | Date | Country | |
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20140171875 A1 | Jun 2014 | US |