MXPA99006875A - Novel device - Google Patents

Abstract

A luer connector comprising a luer connectable to a syringe and which extends to a sharpened end capable of being driven through a puncturable vial closure to thereby puncture the closure;a luer support, mountable on a vial, and which initially supports the luer in a first position in which the sharpened end of the conduit is pointed toward the closure;a luer driver such that movement of the driver relative to the support causes the luer to be driven so that the sharpened end punctures the closure and enters the vial. The luer connector facilitates connection of a hypodermic syringe to the vial.

Description

NEW DEVICE This invention relates to luer connectors. The luer connectors are devices for making it possible to make a connection between the nozzle of a hypodermic syringe and the interior of a pharmaceutical bottle through a perforable rubber closure, so that, for example, water can be introduced into the container. a bottle for reconstituting a drug substance into the bottle, and the reconstituted solution of drug substance can subsequently be sucked out of the bottle by means of the luer connector and into the body of the syringe. The syringe nozzle can then be separated from the luer connector, and a hypodermic needle is attached to the syringe nozzle. The luer connector, therefore, avoids the need to insert a hypodermic needle through the closure, and facilitates a sterile connection between the syringe and the bottle. The luer connectors generally comprise a luer gate, that is, a small female gate in which the syringe nozzle can be inserted, connected to a tubular conduit with a sharp end that can be pushed through the rubber closure of the vial . A number of luer connectors are known, for example the one disclosed in International Publication Number WO 97/10156, which is mounted on a bottle, and requires that the syringe nozzle be inserted into its luer lock, and then use the body of the syringe as an impeller to push the sharp end of your duct through the closure of the vial. This can cause premature operation of the syringe during the pulse operation. Other luer connector constructions are disclosed in Patent Numbers US 530372, EP 0351643A and EP 0587347A. It is an object of this invention to provide an improved luer connector. In accordance with this invention, a luer connector comprises: a luer comprising a luer gate that can be connected to a syringe, and which is in communication with a first end of a channel that passes longitudinally through a tubular conduit, extending the conduit longitudinally from the luer gate to a second end of the channel, the end of the remote tubular conduit of the luer gate being sharpened to be able to be urged through a pierceable bottle closure in order to thereby pierce the closure; a luer support, which can be mounted on a bottle when the bottle is sealed with a pierceable bottle closure, initially supporting the luer support longitudinally movable in a first position where the sharp end of the duct points toward the closure; a luer impeller, mounted on the support, and movable relative to the support, the luer and the impeller having respective coupling parts, in such a way that the movement of the impeller in relation to the support causes the parts of The impeller coupling is supported on the coupling portions of the luer, to drive the luer longitudinally to a second position where the sharp end of the conduit is driven through the closure in order to pierce the closure and enter the bottle. The luer gate can be of an essentially conventional type, comprising a small female gate suitable for the male-female coupling with the nozzle of a conventional hypodermic syringe. The luer can be provided with features, for example, a connection for an adapter, in order to make it possible for the luer to be secured to a hypodermic syringe, to minimize the risk of an accidental disconnection. The luer gate and the conduit can be of an integral construction, for example, the conduit being an integral extension of the gate, and the gate and conduit can be made of plastic materials. Alternatively, the luer gate and conduit can be made separately, and they can be connected together. For example, the conduit can be made of metal, for example, in the form of a steel needle, and the luer gate can be made of a plastic material, the gate and conduit being bonded together, for example, by adhesive or by molding the luer gate around the conduit of metal. By using a sharp metal, instead of a plastic material, the conduit may allow the use of a lower drilling force. The tapered end of the channel may be of any conventionally sharp shape known for these conduits in known luers. The channel can conveniently be opened to the sides leaving the sharpened end of the conduit, to allow the conduit to have a sharp tip. The luer support may comprise a sleeve that can be assembled, for example, by an instantaneous adjustment, a screw adjustment, a friction fit, etc., or other methods apparent to those skilled in the art, around the neck of the bottle, for Hold this way on the neck. Since most conventional bottles have an enlarged projection around the opening of their mouth, an instantaneous fit on this projection is a convenient way by which the sleeve can be mounted on the bottle. By this means, the holder can be mounted in a manner on the neck of the bottle, which does not allow it to rotate, or move longitudinally, or otherwise move on the neck of the bottle. There are known means for mounting this support in the form of a jacket on a bottle. For example, a known means is the one used in the COMAR "Harmony" system, where the shirt and neck of the bottle are provided with cooperative "teeth of engaging" type structures that engage and prevent relative rotation, while a snap-fit groove and projection on the sleeve and neck of the bottle, respectively, prevent the longitudinal separation of the neck from the neck of the bottle. For example, another known means is that of elastic fingers extending longitudinally on the sleeve, which are fastened around a projection on the neck of the bottle, the fingers being secured in this position by means of a restriction collar around the fingers. A system of this type is disclosed, inter alia, in International Publication Number WO 97/10156, and is also commercially used in the LYO-JEC system supplied by Vetter Injekt System GmbH. When mounted on the bottle, the support suitably extends above the mouth of the bottle (the directions are defined relative to the bottom of the bottle when it is erect, although it should be understood that the luer connector of the invention can be used with the vial in other orientations, for example, with its mouth facing down), and may include a portion, for example, an inner flange or flange portions, that rest on the pierceable closure and help stop the closure in place, example, compressing the closure downwards towards the lip of the mouth of the bottle. This flange or flange portions suitably include a central opening to allow the sharp end of the luer to pass through the closure. This central opening can be sealed with a pierceable sealing membrane, which can be integral with (eg, being a thin film of the support material), or can be attached to the flange or flange portions. When mounted on the bottle, the upper part of the support above the mouth of the bottle can form a guide for the luer, for example, in the form of a generally tubular extension, for example cylindrical, defining a compartment that extends above the closure of the bottle, of adequate dimensions so that the luer can be supported therein in its first position with the sharp end of the duct pointing toward the closure. Inside this cylindrical compartment, the luer can be supported with its longitudinal axis, for example, the axis of its channel and / or conduit, coaxial with the cylindrical axis. In the first position of the luer, the sharp end may be in a non-piercing contact with the upper surface of the closure, or spaced from it. Suitably, the inner surfaces of the compartment and the facing portions of the outer surface of the luer may include guides, for example, longitudinal projections and grooves or cooperative grooves, such that the luer is driven from its first position to its second position, and its movement is guided to be smooth and with the minimum amount of deviation from a non-longitudinal path. For example, the guides may comprise a plurality of grooves extending longitudinally on the support where corresponding projections fit, for example, in the form of legs or ribs, etc., of the luer, and within which they can be moved. in a longitudinal way. Alternatively, the projections may be on the luer driver, and the grooves or grooves on the luer. As discussed in more detail later, these guides can also serve to prevent the luer from turning in relation to the support. The luer is suitably provided with one or more stop parts which, when the luer has reached the end of its movement to the second position, i.e., the duct has entered the bottle as much as desired, bump against closure and / or the support, to prevent additional longitudinal movement. These abutment portions may suitably comprise a partial flange or flanges, or legs, etc., extending radially from the outer surface of the conduit, and a corresponding flange, flange portion, bulkhead wall, legs, etc., at the extremity bottom of the compartment. In this construction, when the luer reaches the lower limits of its travel inside the compartment, for example, its second position, the two respective abutment surfaces bump to prevent further downward movement of the luer. The luer and the support can also include respective coupling parts, such that, when the luer has reached the limits of its movement from its first to its second position, with the conduit as far inside the bottle as desired, the luer it is secured in its place in its second position. For example, the inner surface of the support and the outer luer surface may be provided with instantaneous adjustment coupling parts that secure each other when the luer is in its second position. These parts may also comprise or may be mounted on the above mentioned stop parts, or they may be located on other parts of the device. The luer impeller is mounted on the support, in order to have a driving force applied by a user, and as a consequence, the luer driver transmits the longitudinal force to the luer, to drive the luer from its first to its second position, in such a way that the closure be pierced. The luer impeller can initially move in relation to both the support and the luer, so that the movement of the luer impeller in relation to the luer under the action of the impulse force, leads to its respective coupling parts up to a coupling In a preferred construction, the luer impeller can be rotated in relation to the support and the luer, for example, by means of a manual twisting action, and the respective coupling means on the luer and the impeller comprise screw thread portions. of coupling, in such a way that the coupling of the screw thread parts on the rotary movement causes the luer to screw down towards the second position. In this construction, the driver parts are constructed and configured to be held by the user and rotated, and these parts can conveniently be provided with fastener enhancing features., for example, external ribs or a gnarled surface, and so on. For example, the impeller may comprise a cylindrical jacket or partial sleeve, coaxial with an upper part of the support, which is in the form of a cylindrical compartment as described above, and being able to rotate coaxially on the upper part of the support. Suitably, this impeller can surround an upper part in the manner of a surrounding jacket or skirt. In an alternative way, the luer driver may be inside and surrounded by the support, and the support, in this construction, may be in the form of a liner surrounding the luer driver. The luer impeller may suitably be in the form of a closure, for example, a lid that closes the upper end of the compartment, for example, having a fully or partially closed end on the compartment when the impeller is in place. This lid can help provide a sterile compartment seal. The support and impeller sleeves can be tightly adjusted but can be moved slidably together, also helping to provide a sterile seal between the support and the impeller. When the impeller is in the shape of this lid, the user can conveniently apply a manual force to the impeller without a manual contact with the luer enclosed inside the compartment, thus avoiding contamination. The aforementioned sealing membrane that closes the opening in the flange or flange portions of the support can further contribute to the sterile sealing of the compartment. Additional sterile seals can be provided in other parts of the construction, conveniently providing several lines of seals. The screw thread portions may be a total or partial screw thread, or a screw thread on one of the impeller and the luer, and a projection capable of engaging the screw thread on the other. Suitable screw thread structures will be apparent to those skilled in the art. For example, when the luer driver is in the manner described above, a screw thread or a partial screw thread can be located on an internal surface of the sleeve, which can be coupled with a corresponding partial screw screw thread or screw thread. , or projection capable of coupling with the screw thread, on a facing surface of the luer, for example, of the luer gate. In this construction, the luer impeller may have a lower part in the form of a jacket that surrounds and can be rotated on the support, and an upper part that includes the screw thread described above. Alternatively, a screw thread may be formed on a portion of the impeller, which extends into the compartment of the upper part of the support. For example, when the impeller is in the form of a surrounding outer skirt, a screw thread may be formed on the inner surfaces of an internal skirt that extends axially into the compartment and surrounds the luer, and the luer may have portions thereof. screw thread cooperatives of the type described above on their facing external surface. When the impeller is in the form of a lid, as described above, this internal skirt can descend axially from the fully or partially closed end. When the respective coupling elements on the luer and the impeller comprise these screw thread parts, in general it will be necessary to provide the luer with some element to resist rotation with the luer driver, when the luer driver is rotated on the support, such that a relative rotation of the luer and the impeller can be presented, and consequently, the action of screw thread. This can be achieved by providing the luer and the support with respective cooperative portions that engage to prevent rotation. For example, the aforementioned guides, which guide the luer to follow a longitudinal trajectory, can also serve in a convenient way to achieve this. For example, the luer may have parts that fit within a guide in the holder, which prevents this rotation, or the luer may be in a sectional manner that prevents rotation (e.g., polygonal or oval, instead of a section). circular), or the luer can be provided with legs projecting to the sides that engage the longitudinally aligned guides, for example, grooves in the inner surface of the support. These legs may also conveniently comprise the instantaneous adjustment connection parts described above, which fit together when the luer is in its second position, and / or may comprise stop parts. In this construction, the rotation of the impeller around the support, and the engagement of the screw thread portions on the luer and the impeller, cause the luer to screw down from the first position towards the second position, and cause the Sharp end of the conduit is pushed through the closure to pierce it. When the impeller is in the form of a jacket, for example, a lid as described above, having a fully or partially closed end on the compartment when the impeller is in place, it will normally be necessary to build this lid that can be removed easily from the holder to expose the luer gate for use when the conduit has been driven through the closure. When an impeller in the form of a lid can be rotated on the support to operate the screw thread action described above, it is necessary that this facility to remove the lid is also combined in the construction with the ability to rotate without becoming detached accidentally during the rotation to operate the screw thread. This can be achieved in a preferred construction by providing the luer abutment parts as described above, and by providing screw thread portions that are of such dimensions that, when the conduit has entered the flask as far as desired or is allowed by the Stop parts, the screw thread parts on the luer driver and the luer are still engaged, so that their relative rotation continues to generate an upward thrust on the luer driver to force it out of the holder. The luer support and impeller can have their respective facing surfaces, provided with circumferential protruding parts and a coupling groove, which allow rotation and guide them to a smooth rotation about the axis of the jackets, while restricting the relative axial movement. These protruding parts and a groove can be constructed in such a way that the impeller can be separated from the support by an instantaneous decoupling of the projection from the groove as the impeller moves in the axial direction. When the luer reaches the limit of its movement, the continuous relative rotation of the sleeves, in the manner described above, can generate an upward force on the impeller, which forces the projection and groove out of its coupling, and allows the impeller is removed axially from the support. For example, this can be achieved by a construction of the luer connector of this invention wherein the luer driver and the luer have respective mating screw threads thereon, and wherein the luer and the support are provided with mating surfaces. respective stop, in such a way that the lower limit of travel of the luer inside the support is reached when they abut the respective abutment surfaces, and where, when the luer is in its first position, the respective abutment surfaces are separated by a distance longitudinal that is less than the longitudinal distance that can be moved luer impeller by the action of luer impeller screw. In this constructionWhen the stop surfaces on the luer meet against the stop surface on the luer support, the luer has reached the lower limit of its travel in relation to the support, and has not yet reached the lower limit of travel on the thread of the luer. luer impeller screw In this construction, when the abutment surfaces are in contact, the continuous rotation of the luer impeller in relation to the luer, will force the luer impeller upwards, and this can be arranged to be sufficient for the luer impeller and the support to be forced longitudinally. out of engagement with one another, in such a way that the luer impeller can be removed, for example, in the form of a lid. The suitable relative dimensions and configurations of the screw thread on the luer impeller and the support can be easily determined by experimentation. To prevent accidental or unintentional relative movement of the impeller and bracket, the bracket and impeller can be initially connected with breakable connectors, for example, a small spot weld or strips of thin plastic material, etc. (many suitable constructions will be apparent by the experts in this field). These break when a movement relative to the impeller is intentionally applied to operate the device. These connectors can also function as an evidence element of forcings to detect forcings. Accordingly, in a preferred embodiment of the invention, a luer connector comprises: a luer, which can be connected to a syringe, the luer comprising a luer gate in communication with a first end of a channel that passes longitudinally through a conduit tubular that extends integrally and longitudinally from the luer gate to a second end of the channel, the end of the remote tubular conduit of the luer gate being sharpened to be able to be driven longitudinally through a pierceable bottle closure, in order to pierce this way the closure; a luer support, which comprises a sleeve that can be mounted around the neck of the bottle, to thereby be retained on the bottle when sealed with a perforable bottle closure, the support extending up to an upper part above the mouth of the bottle in the form of a generally cylindrical compartment extending above the closure of the bottle, and forming a guide for the luer, the compartment being of adequate dimensions for the luer to be supported therein longitudinally movable in a first position where the Sharp end of the conduit points towards the non-perforated seal; a luer impeller, mounted on the support, capable of having a rotational movement in relation to the support and the luer, the impeller comprising a cylindrical sleeve or partial sleeve, coaxial with the upper part of the support, the impeller being in the form of a cover on the compartment on the top of the support, and having a fully or partially closed end on the compartment when the impeller is in place; the luer and the impeller having respective screw thread coupling parts, such that the engagement of the screw thread portions on the rotary movement causes the luer to screw down to a second position, where it is driven the sharp end of the duct through the closure to pierce the closure and enter the vial. In a more preferred embodiment of the invention, a luer connector comprises: a luer, which can be connected to a syringe, the luer comprising a luer gate in communication with a first end of a channel that passes longitudinally through a tubular conduit that extends integrally and longitudinally from the luer gate to a second end of the channel, the end of the remote tubular conduit of the luer gate being sharpened to be longitudinally driven through a pierceable bottle closure, in order to thereby perforate the close; a luer support, comprising a liner that is assembled and fitted around the neck of the bottle, to thereby be retained on the bottle when it is sealed with a pierceable bottle closure, the support extending up to an upper part of the mouth of the bottle. a bottle in the form of a generally cylindrical compartment extending above the closure of the bottle, and forming a guide for the luer, the compartment being of adequate dimensions for the luer to be supported therein longitudinally movable in a first position where the Sharp end of the conduit points towards the non-perforated seal; a luer impeller, mounted on the support, and capable of having a rotational movement in relation to the support and the luer, the impeller comprising a cylindrical sleeve or partial sleeve, coaxial with the upper part of the support, the impeller being in the form of a lid on the compartment of the upper part of the support, and having a totally or partially closed end on the compartment when the impeller is in place; the luer and the impeller having respective screw thread coupling parts, in such a way that the engagement of the screw thread portions on the rotary movement causes the luer to screw down towards a second position, where urges the sharp end of the conduit through the closure to pierce the closure and enter the vial; the luer and the support being provided with respective abutment surfaces, in such a way that the lower limit of travel of the luer is reached inside the support when they abut the respective abutment surfaces, and where, when the luer is in its first position, the respective abutment surfaces are separated by a longitudinal distance that is smaller than the longitudinal distance that the luer impeller can be moved by the screw action of the luer impeller, in such a way thatWhen the stop surfaces on the luer abut against the stop surface on the luer support, the luer has reached the lower limit of its travel in relation to the support, and has not yet reached the lower limit of its travel on the thread of the luer driver screw, and the continuous rotation of the luer driver in relation to the luer will force the luer driver and the support longitudinally out of engagement with each other. All the component parts of the luer connector of this invention can be made of plastic materials of the same class as used with known luer connectors, or as mentioned above, some parts, such as the conduit, can be made of metal, such as stainless steel. The luer connector of the invention provides the advantage that, by operation of the impeller, the luer conduit can be driven in an easy and controllable manner through the closure, and if the impeller is in the shape of the lid described above, The luer can be kept sterile throughout this operation.

In a further aspect, the invention provides a luer comprising a luer gate, which can be connected to a syringe, the gate being in communication with a first end of a channel passing longitudinally through an integrally extending tubular conduit and longitudinally from the luer gate to a second end of the channel, the end of the remote tubular conduit being of the sharp luer gate, suitable for use in a luer connector as described above. In a further aspect, the invention provides a luer holder, which can be mounted on a bottle when sealed with a pierceable bottle closure, suitable for use in a luer connector as described above. In a further aspect, the invention provides a luer driver, suitable for use in a luer connector as described above. In a further aspect, the invention provides a pharmaceutical bottle having a perforable rubber seal that seals the opening of its mouth, mounted with a luer connector as described above. In a further aspect, the invention provides the use of a luer linker as described above, in the dosage of a pharmaceutical formulation initially contained in a pharmaceutical bottle. The invention will now be described by way of example only with reference to the accompanying drawings, which show: Figure 1 shows a longitudinal section through a first type of luer connector of the invention, with its luer in its first position. Figure 2 shows a longitudinal section through the luer connector of Figure 1, with its luer in its second position, and the impeller in place on the support. Figure 3 shows a longitudinal section through the luer connector of Figure 1, with its luer in its second position, and the impeller removed from the support. Figure 4 shows a longitudinal section through the luer connector of Figure 1, with its luer in its second position, with the impeller removed from the support, and connected to a jingling. Figure 5 shows a longitudinal section through a second type of luer connector of the invention, with its luer in its first position. Figure 6 shows a longitudinal section through the luer connector of Figure 5, with its luer in the second position and the impeller in place on the support. Figure 7 shows a view in longitudinal section partially cut away through the luer connector of Figure 5, with its luer in its second position, and the impeller removed from the support.

Figure 8 shows a partially sectioned plan view in sections of the luer connector of Figure 1. Figure 9 shows a longitudinal section through the luer connector of Figure 5, showing more clearly the operation of the screw thread portions. Referring to Figures 1 to 4, a luer connector and its use are shown. A pharmaceutical bottle 1 is shown, the upper part of which is formed in a neck 2, which ends in a mouth that opens surrounded by an annular projection 3. The opening of the mouth is closed by a perforable rubber closure 4, additionally covered by a sterility membrane 5. The luer connector comprises a luer 6 (global) comprising a female luer gate 7 that can be connected to a syringe 8, the luer gate 7 being in communication with a channel 9 that passes longitudinally through a tubular conduit 10, extending longitudinally from the luer gate 7, the end 11 of the tubular conduit 10 remote from the luer gate 7 being sharpened to be able to be driven through the central part of the closure of the pierceable bottle 4, in order to perforate in this way the closure 4. The gate luer 7 the conduit 10 are of an integral construction, the conduit 10 being an integral extension of the gate 7. Mounted on the neck 2 of the bottle 1, there is a 12 luer support (global). The luer support 12 can be mounted by an instantaneous adjustment on the projection 3 around the neck 2 of the bottle, to be held in this way on the neck. The part of the support 12 that is mounted on the projection 3 is not shown in detail, since there are different types of assembly, as discussed above. As shown in Figure 1, the support stops the luer 6 longitudinally movable in a first position, where the sharp end 11 of the duct 10 points towards the closure 4. The support 12 extends to an upper part 13 above the mouth of the bottle, and includes an inner flange 14 that rests on the pierceable closure 4, and helps to stop the closure 4 in place, compressing the closure 4 downward towards the mouth of the bottle 1. The flange 14 includes a central opening 15 to allow the sharp end 11 of the luer to pass through the closure 4. The sterility membrane 5 is attached to the flange 4, to close the central opening 15. The upper part 13 of the support also forms a generally tubular compartment, cylindrical example 16, which extends above the closure of the bottle 4, of suitable dimensions so that the luer 6 can be supported therein in its first position with the sharp end 11 of the duct 10 pointing towards the closure 4. Inside this cylindrical compartment, the luer 6 is supported with its longitudinal axis coaxial with the cylindrical axis. In the first position of the luer 6, the sharp end 11 is in a non-piercing contact with the upper surface of the closure 4. Mounted on the upper part of the support, there is a luer driver 17 (overall) in the form of a cylindrical sleeve, coaxial with the upper part 13 of the support 12, and which can rotate coaxially on the upper part 13 of the support 12. The impeller 17 surrounds the upper part 13 in the manner of a surrounding skirt, and is in the form of a cover that closes the upper end of the compartment 16, having a fully closed end 18 on the compartment 16. The sleeves fit tightly together to provide a sterile seal between the impeller 17 and the compartment 16. The sleeves have their respective facing surfaces provided with parts circumferential projections 19 and a coupling groove 20, which allow relative rotation, and guide the sleeves in a smooth rotation about the axis of the sleeves as, while restricting relative axial movement. The impeller 17 and the luer 6 are provided with respective coupling elements. These comprise the coupling screw thread portions 21, 22, respectively, on the impeller 17 and the luer 6. The screw thread portions 21, 22 comprise an entire screw thread 21 formed on the inner surfaces of an inner skirt 23 that descends axially from the closed end 18 of the impeller 17, and extends axially to the compartment 16 to surround the luer 6, and a projection 22 on the luer 6 that can be engaged with the screw thread 21 on the internal skirt 23. The coupling of the screw thread parts 21, 22 on the rotary movement of the impeller 17 and the luer 6, causes the luer 6 to screw down towards the second position, as shown in Figure 2. The internal surfaces of the upper part 13 of the support 12, and the facing portions of the external surface of the luer 6, include guides comprising legs 24 projecting sideways from the luer 6, and engaging with the slots corresponding ngitudinales 25 in the upper part 13 of the support 12. These legs 24 and grooves 25 guide the luer 6 as it is driven longitudinally from its first position to its second position by coupling the screw thread parts 21, 22, in such a way that the longitudinal movement of the luer 6 is smooth and with the minimum amount of deviation from a non-longitudinal path. It is necessary to provide the luer with 6 elements to resist rotation when the impeller 17 is rotated on the support 12, in such a way that the relative rotation of the luer and the impeller can be presented, and consequently, the action of screw thread. This is achieved by the engagement of the legs 24 and the slots 25. The legs 24 also comprise stop parts which, when the luer 6 has reached the end of its movement to the second position, as shown in Figure 2, bump. against the upper surface 26 of the flange portion 14 of the support, to prevent further longitudinal movement of the luer. The luer 6 also has legs 27 which engage in an instantaneous adjustment manner with the recesses 28 on the support when the luer 6 has reached the limits of its movement to its second position, as shown in Figure 2, in such a way that the luer is secured in its place in its second position. The legs 27 also comprise additional stop parts, which abut against the surface 26. The circumferential projection portions 19 and the coupling groove 20, which allow relative rotation, and guide the liners in a smooth rotation about the axis of the legs. The sleeves, while restricting relative axial movement, also provide an instantaneous adjustment barrier to the removal of the impeller 17 in the axial direction from the support 12. The screw thread portions 21, 22 are of such dimensions that, when the conduit 10 has entered the bottle 1 as far as allowed by the stop parts, as shown in Figure 2, the screw thread portions 21, 22 on the impeller 17 and the luer 6 are still engaged. Its relative rotation continues, consequently, generates an upward thrust on the impeller 17, to uncouple it from the support 12 by means of an instantaneous adjustment decoupling of the circumferential projection parts 19 and the coupling groove 20, as shown in Figure 2 The upper part 13 of the support 12 is elastic, and the flexibility is assisted by the presence of the grooves 25, which facilitate the separation of the protruding parts 19 from the groove 20. To prevent an accidental or unintentional relative movement of the impeller 17 and the support 12, the support 12 and the impeller 17 are initially connected with a small spot weld at 29. This is broken when a movement relative to the impeller is intentionally applied to operate the device, and also functions as an evidence element of forcing, to detect the forcings. The operation of the luer connector of the invention can be seen in Figures 1 to 4. With the connector as shown in Figure 1, with the non-perforated closure 4, the impeller 17 is rotated by a manual twisting action, while that the bottle 1 is also stopped. This causes the screw screw parts 21, 22 to engage to screw the luer 6 downwards, causing the tip end 11 of the duct 10 to pierce the closure 4 and enter the bottle 1. When the luer 6 has reached the limit of its downward movement, the abutment portions 24, 27 abut against the flange 14, to prevent further downward movement of the luer, and the instantaneous adjustment coupling parts 27, 28 engage to secure the luer 6 in place, as shown in Figure 2. The continuous rotation of the impeller 17 forces the impeller 17 out of the support 12 against the instantaneous fit engagement of the projection 19 and the groove 20, as shown in FIG. Figure 3. Lu A syringe 8 can be connected to the luer flap 7, using an adapter 30 to securely link the gate and the nozzle 31 of the syringe 8 together, if desired, as shown in Figure 4. Referring to the Figures 5 to 9, the corresponding parts in function and operation to the corresponding parts of Figures 1 to 4, are numbered in a corresponding manner, and only the differences are described in detail. In its essential principles, the luer connector of Figures 5 to 9 are identical to those of Figures 1 to 4. In Figure 5, the luer holder 12 is again in the form of a sleeve mounted on the neck of the bottle 1. The luer driver 17 is again in the form of a jacket coaxial with the upper part 13 of the support in the manner of a skirt, and it can rotate on the part 13. The impeller 17 has an integral upper part 32 that is formed with ribs 33, to assist the fastening by the user. The inner surface of this upper part 32 is provided with a screw thread 21. The luer holder forms a sterile seal with the luer driver at point 34, wherein the conical surfaces of the uppermost lip coupling of part 13 and above The luer impeller 17 meet and form a cone / cone surface seal. This seal can be improved by a silicone application. Inside the compartment 13 and the upper part 17, a luer 6 of a construction similar to that of Figures 1 to 4 is located. However, instead of the projection 22 used in Figures 1 to 4, there is a helical thread 35 on the. external surface of the luer gate 7, which engages with the thread 21. Instead of the legs 24 used in Figures 1 to 4, the luer 6 is provided with a stop flange 36, which, as shown in FIG. Figure 8, at its periphery is formed in a configuration of gear teeth, wherein the teeth 37 engage the corresponding longitudinal grooves 38 on the inner surface of the compartment 13, and this coupling guides the luer to a smooth longitudinal movement down to the compartment 13, and prevents the relative rotation of the luer 6 and the support 12. As shown more clearly in Figure 6, the rotation of the luer driver 17 screws the luer 6 downwards in a manner similar to that of Figures 1 to 4, such that the sharp end 11 pierces the closure 4 and enters the bottle (not shown in Figure 6). The extent of downward movement of the luer is determined by the stop of the stop flange 36 against the upper surface 26 of the flange portion 14 of the support, to prevent additional longitudinal movement of the luer 6. At the same time, the small fins in the form of a wedge 39 on the conduit are coupled below the flange 14 to hold the luer in place. As shown in Figure 6, the luer 7 is in its second position. The continuous rotation of the luer driver 17 with the luer 6 abutting against the flange 14, applies an upward force to the luer driver 17, and as shown in Figure 7, forces the luer driver 17 and the support 12 out of engagement, until they come to separate completely, as shown in Figure 7. Next, a syringe 8 (not shown) can be connected to the luer gate 7 in a manner identical to Figure 4. Referring to Figure 9, which in part reproduces Figure 5, as described above, when the luer 6 is in its first position, as shown in Figure 9, the abutment surfaces 36 and 26 are separated by a longitudinal distance Ll. The longitudinal distance that the luer 7 can be moved by the screw action of the luer driver 32, for example, the longitudinal distance between the upper 40 and lower ends 41 of the screw thread part 21 on the luer driver 32, is L2 , corresponding in this case to the entire length of the screw thread on the luer driver 32. L2 is greater than Ll, in such a way that, when the abutment surfaces 36 and 26 are in contact, the continuous rotation of the luer driver 32. in relation to luer 6 it continues to apply a longitudinal force downwards towards the luer. Since the abutment surfaces prevent further downward movement of the luer, this results in an upward reaction force, which forces the luer driver up and longitudinally out of engagement with the support, allowing the luer driver to separate. 32, as shown in Figure 7. The same principle is applied to the luer connector of Figures 1 to 4. It will be appreciated that the luer connector construction described above, it can easily be provided with evidence of forcing characteristics, for example, small links of breakable plastic material between the skirt 17 and the support 12, or a tear-off label that bridges the skirt 17 and the support 12, which tends to tear if the luer driver 17 is rotated in relation to the skirt 12. Other types of forcing evidence construction will be apparent to those skilled in the art.

Claims (12)

1. A luer connector, which comprises: a luer comprising a luer gate that can be connected to a syringe, and which is in communication with a first end of a channel that passes longitudinally through a tubular conduit, the conduit extending longitudinally from the luer gate to a second end of the channel, the end of the remote tubular conduit of the luer gate being sharpened to be able to be driven through a pierceable bottle closure in order to thereby pierce the closure; a luer support, which can be mounted on a bottle when the bottle is sealed with a pierceable bottle closure, initially supporting the luer support longitudinally movable in a first position where the sharp end of the duct points toward the closure; characterized by: a luer impeller, which is movably mounted in a movable manner on the support, and is coupled to the support, the luer and the impeller having coupling screw threads thereon, in such a way that the coupling of the luer the screw thread parts and the relative rotation of the impeller and the luer, cause the luer impeller to rest on the luer, to drive the luer longitudinally to a second position, where the sharp end of the conduit is driven through the closure , to drill the closure and enter the bottle. A luer connector according to claim 1, characterized in that: the luer is provided with one or more stop parts, which, when the luer has reached the end of its movement to the second position, prevent further longitudinal movement of the luer. luer, and the configuration of the screw thread portions and the stop parts is such that, when the conduit has entered the flask as far as desired or as permitted by the stop parts, the screw thread portions on The luer driver and the luer are still coupled, such that their relative rotation continues to generate an upward thrust on the luer driver, to force the luer driver out of engagement with the support. A luer connector according to claim 1 or 2, characterized in that the luer support comprises a sleeve that can be mounted around the neck of the bottle, to thereby be retained on the neck, and extends above the mouth of the bottle , and the upper part of the support above the mouth of the mouth of the bottle is in the form of a generally tubular extension defining a compartment that extends above the closure of the bottle, of adequate dimensions so that the luer can be supported in the same in its first position, with the sharp end of the duct pointing towards the closure. A luer connector according to claim 1, 2, or 3, characterized in that the luer and the support include respective coupling parts, such that, when the luer has reached the limit of its movement from its first to its Second position, with the conduit as far inside the bottle as desired, the luer is secured in place in its second position. A luer connector according to any of claims 1 to 4, characterized in that the luer driver is in the form of a closure that closes the upper end of the compartment. A luer connector according to claim 5, characterized in that the luer driver is in the form of a lid that closes the open upper end of the compartment by means of the luer driver, which has a fully closed end that forms a closing surface on the open end of the compartment. A luer connector according to any of claims 1 to 6, characterized in that the luer is provided with elements to resist rotation with the luer driver, when the luer driver is rotated on the support, in such a way that it can be presented the relative rotation of the luer and the impeller, and therefore, the coupling of the screw thread parts. A luer connector according to any of claims 1 to 7, characterized in that the support and the luer driver have their respective facing surfaces provided with circumferential projection parts and a coupling groove, which allow the rotation and the guides in rotation around the axis of the liners, while restricting the relative axial movement, and which are constructed in such a way that the impeller can be separated from the support by an instantaneous decoupling of the projection from the groove, when the impeller moves in the axial direction. A luer connector according to any of claims 1 to 8, characterized by a construction wherein the luer driver and the luer have respective engagement screw thread portions thereon, and wherein the luer and the support are provided with respective abutment surfaces, such that the lower limit of travel of the luer is reached within the support when they meet the respective abutment surfaces, and where, when the luer is in its first position, the respective abutment surfaces are separated by a longitudinal distance that is smaller than the longitudinal distance that the luer impeller can be moved by the screw action of the luer impeller. 10. A luer connector, comprising: a luer, which can be connected to a syringe, the luer comprising a luer gate in communication with a first end of a channel that passes longitudinally through a tubular conduit that extends integrally and longitudinally from the luer gate to a second end of the channel, the end of the remote tubular conduit of the luer gate being sharpened to be driven longitudinally through a pierceable bottle closure, in order to thereby pierce the closure; a luer support, which comprises a sleeve that can be mounted around the neck of the bottle, to thereby be retained on the bottle when sealed with a perforable bottle closure, the support extending up to an upper part above the mouth of the bottle in the form of a generally cylindrical compartment extending above the closure of the bottle, and forming a guide for the luer, the compartment being of adequate dimensions for the luer to be supported therein longitudinally movable in a first position where the Sharp end of the conduit points towards the non-perforated seal; a luer impeller, mounted on the support, capable of having a rotational movement in relation to the support and the luer, the impeller comprising a cylindrical sleeve or partial sleeve, coaxial with the upper part of the support, the impeller being in the form of a cover on the compartment on the top of the support, and having a fully or partially closed end on the compartment when the impeller is in place; the luer and the impeller having respective screw thread coupling parts, such that the engagement of the screw thread portions on the rotary movement causes the luer to screw down to a second position, where it is driven the sharp end of the duct through the closure to pierce the closure and enter the bottle, and the luer is provided with one or more stop parts which, when the luer has reached the end of its movement to the second position, prevent a movement additional length of the luer, and the dimensions of the screw thread portions are such that, when the conduit has entered the flask as far as desired or as permitted by the stop parts, the screw thread portions on the impeller luer and the luer are still coupled, in such a way that their relative continuous rotation generates a push up on the luer impeller, to force the luer impeller out of engagement with the support. 11. A luer connector, comprising: a luer, which can be connected to a syringe, the luer comprising a luer gate in communication with a first end of a channel that passes longitudinally through a tubular conduit that extends integrally and longitudinally from the luer gate to a second end of the channel, the end of the remote tubular conduit of the luer gate being sharpened to be longitudinally driven through a pierceable bottle closure, in order to thereby pierce the closure; a luer support, comprising a liner that is assembled and fitted around the neck of the bottle, to thereby be retained on the bottle when it is sealed with a pierceable bottle closure, the support extending up to an upper part of the mouth of the bottle. a bottle in the form of a generally cylindrical compartment extending above the closure of the bottle, and forming a guide for the luer, the compartment being of adequate dimensions for the luer to be supported therein longitudinally movable in a first position where the Sharp end of the conduit points towards the non-perforated seal; a luer impeller, mounted on the support, and capable of having a rotational movement in relation to the support and the luer, the impeller comprising a cylindrical sleeve or partial sleeve, coaxial with the upper part of the support, the impeller being in the form of a lid on the compartment of the upper part of the support, and having a totally or partially closed end on the compartment when the impeller is in place; the luer and the impeller having respective screw thread coupling parts, in such a way that the engagement of the screw thread portions on the rotary movement causes the luer to screw down towards a second position, where propels the sharp end of the duct through the closure to pierce the closure and enter the vial; the luer and the support being provided with respective abutment surfaces, in such a way that the lower limit of travel of the luer is reached inside the support when they abut the respective abutment surfaces, and where, when the luer is in its first position, the respective abutment surfaces are separated by a longitudinal distance that is less than the longitudinal distance that the luer impeller can be moved by the screw action of the luer impeller, in such a way that, when the abutment surfaces on the luer abut against the surface of stop on the luer support, the luer has reached the lower limit of its travel in relation to the support, and has not yet reached the lower limit of its travel on the screw thread of the luer impeller, and the continuous rotation of the impeller luer in relation to the luer will force the luer driver and the support longitudinally out of engagement with one another. 1

2. A pharmaceutical bottle having a pierceable closure that seals the opening of its mouth, mounting the bottle with a luer connector as claimed in any of the preceding claims.