The present invention relates to male and female Luer and Luer-Lock connectors and a connection system comprising of one of a male and a female Luer or Luer-Lock connector, respectively, that exclude any mix-up between Luer connectors.
Luer connection systems comprising male and female Luer connectors are known in the prior art in different embodiments. Luer connectors are standardized international with ISO standard 594 or Europe-wide with EN 20594 (or EN 1707) and Germany-wide with DIN EN 20594. The Luer connection system enables a manufacturing of manufacturer independent secure, leak-proof and sterile connections in particular in the medical-technical field. The standardized standard Luer connectors of different manufacturers can be combined arbitrarily with each other. For example, in using the Luer connection system syringes and canulae of different manufacturers can be combined arbitrarily with each other.
A male standard Luer connector comprises a tubular body that comprises a conical outer sheath. This conical outer sheath comprises a slope from the peak to the base of 6% according to the standard. The female standard Luer connector comprises a hollow reception body that comprises a conical hood-shaped reception that also comprises a slope of 6%. At the outer end of the female standard Luer connector it comprises a collar that often protrudes radially to the outside. The female standard Luer connector can be mounted onto the male standard Luer easily and can be connected secure and gas-proof by means of a friction fit. In a likewise easy manner the connection can be released again.
Besides the common standard Luer connection system also so called Luer-Lock connection systems are known in the prior art. They additionally comprise at the male Luer connector a thread that may engage into the radially protruding latching element in order to latch the male and female Luer connector by means of a rotation. By this, the Luer connection is guaranteeing tensile strength.
Commonly the female Luer connectors are arranged at a canula or a catheter or at the inlet of a conduit. Male Luer connectors are mostly arranged at a syringe, a feed tank, a medical device or at the outlet of a conduit.
The Luer connection systems known from the prior art have the disadvantage that due to the desired compatibility of the individual connectors among each other there are considerable risks of mix-ups. Thus, originally the Luer connection system was intended to be used according to the above-mentioned standards only for the connection between disposable syringes or injection canulae, respectively, and other medical devices, e.g. transfusion devices. Its easy and comfortable and secure handling, however, lead to a broad use also in different medical applications. Mix-ups that result from wrong connections can be dangerous to life for the patient.
Due to the fact that the Luer connection system is equally shaped for different applications like vascular and spinal or peridural, respectively, and partially also for enteral (e.g. feeding tubes) and respiratory applications, there is the risk that a medicine to be venously injected is wrongly applied spinal. For example, there is the risk that an intravenous port, at which a female Luer connector is arranged, is wrongly connected to a conduit with a male Luer connector, at which a medicine has to be applied enteral.
Such mix-ups and other problems have been discussed, among other things, in the technical report of DIN (DIN technical report 88:2000) from the year 2000 with the title “Luer connections—a report of the CEN Forum Task Group “Luer fittings”; German translation of the CR 13825:2000”.
From document WO 2008/009946 A1 a Luer connector system is known in which a male Luer connector is able to connect only to a particularly codified female Luer connector.
From document EP 1 083 963 A1 a special connection system comprising a security index for liquids in the medical field is known.
The technical problem to be solved by the present invention is, thus, to improve the Luer connection system and its male and female connector such that a mix-up of different medical systems is prevented during application in a cost-efficient way and without any extensive changes of the existing connection systems.
The above-mentioned problem is solved according to the invention by a male Luer connector according to claim 1, a female Luer connector according to claim 11 as well as a connection system comprising a male and a female Luer connector according to claim 15.
In particular, the above-mentioned problem is solved by a male Luer connector comprising a tubular body with a conical outer sheath, and a connection blocking element wherein the connection blocking element delimits a space around the tubular body and forms a codification stopper in axial direction.
The connection blocking element of the male Luer connector is configured, by means of its codification stopper arranged in axial direction, to mechanically prevent a connection of the male Luer connector with a female standard Luer connector or a standard Luer-Lock connector, but to enable a connection with a fitting female Luer connector that is inversely shaped. The codification stopper of the male connector is shaped complementary to a codification notch of the fitting female Luer connector such that these codification elements enable or prevent a connection of Luer connectors of the present invention according to the “key-lock-principle”. During connection of fitting Luer connectors the codification stopper is able to pass by the codification notch. The key-lock-principle of the Luer connectors of the present invention has the advantage that any mix-ups of Luer connectors, that are for example used at a patient at the same time, are excluded. In particular, a male Luer connector according to the invention prevents, for example for a medicine to be applied enteral, that this is wrongly connected to an intravenous port with a female standard Luer connector. The codification stopper, hereby, prevents a mounting of a female standard Luer connector.
Particularly, Luer connection systems that are used for a distinctive application field have a particular codification. A corresponding codification stopper, thus, comprises a defined geometric shape. Thereby, it is ensured that mix-ups of the Luer connection systems with each other are impossible because only these female Luer connectors can be connected to the codified male Luer connector that comprise a corresponding shape that fits to the codification stopper of the male Luer connector.
The connection blocking element of the male Luer connector can be injection molded preferably together with the tubular body such that existing production processes for these connectors can be maintained.
Due to the fact that the connection blocking element only delimits a space around the tubular body and forms a codification stopper the tubular body can be realized unchanged with its conical outer sheath according to the Luer standard. Thus, no problems will arise with regard to the leak-tightness of the connection or similar issues.
Preferably, the connection blocking element comprises at least one protrusion rigidly connected to the tubular body that extends axially in a tubular shaped space around the tubular body. The prevention of the connection by means of one or multiple protrusions is particularly advantageous because, hereby, a coupling of unfitting male and female Luer connectors is mechanically prevented in an easy way. The female standard Luer connector abuts during trying to connect to the protrusion of the male Luer connector and cannot mechanically surmount it. Furthermore, such protrusions that extend axially in a tubular shaped space around the tubular body can be manufactured easily, for example injection molded, and need only little additional material.
Preferably, the male Luer connector is a male Luer-Lock connector and further comprises a threaded body with an internal thread, wherein the codification stopper of the connection blocking element is attached to the outer end of the threaded body. Also at a male Luer connector with an internal thread the connection blocking element prevents with its codification faces the mechanical connection with an unfitting female Luer-Lock connector or a standard Luer-Lock connector.
Preferably, the connection blocking element is a separately manufactured, preferably hood-shaped, member that is connected to the male Luer connector. Thereby, the connection blocking element can be refitted easily to existing apparatuses or devices with a Luer connection. For this, the separately manufactured connection blocking element is attached to the existing male Luer connector, for example by mounting, adhering, screwing, welding or by similar attachment means. If the connection blocking element is preferably a hood-shaped member it can be for example mounted easily to a hood around the actual male Luer cone. For securing the connection it can additionally be adhered or welded. The hood can at the same time be the threaded body of a male Luer-Lock connector.
Preferably, the connection blocking element comprises two opposed codification stoppers. Thereby, a mechanical connection can be codified particularly advantageous that also cannot be connected wrongly in trying a diagonal connection. Thus, the likelihood of any mix-ups can be reduced further.
Preferably, the two opposed codification stoppers are shaped by two opposed protrusions.
Preferably, the codification stoppers are equally shaped. Thereby, the Luer connection can be connected in two different axial angle positions of the connectors towards each other.
Alternatively, the codification stoppers are differently shaped. Thereby, more codification possibilities are available in order to codify more different connection systems for different applications.
Preferably, the codification stopper, seen in axial direction, comprises a straight, triangular, rectangular, segment of a circle shaped or trapezoid silhouette. These shapes of the codification stopper result also in the present small dimensions of the Luer connectors in a secure codification.
Preferably, the connection blocking element is manufactured separately from the tubular body and comprises a hollow cylindrical reception with which the connection blocking element is connectable to the threaded body of the male Luer-Lock connector. This has the advantage that the connection blocking element can be manufactured more easily separate than together with the threaded body of the Luer-Lock connector. This leads to savings in the production of such male Luer-Lock connectors.
Alternatively, the connection blocking element is integrally formed with the male Luer connector. This is in particular advantageous since the integral formation of the male Luer connector according to the invention is particularly robust and a release of the connection blocking element from the male Luer connector is impossible. Apart from that, any installation procedures are omitted by an integral formation.
The above-mentioned problem is also solved by a female Luer connector, comprising a hollow reception body with a conical reception, and a collar at the outer end of the reception body, wherein the collar comprises at least one codification notch.
The codification notches of the female Luer connector are configured in such a way that the female Luer connector can be connected to an above described hereto fitting male Luer connector. Thereby, it is particularly advantageous that the female Luer connector can also be connected to a male standard Luer connector. However, due to the codification of the female Luer connector according to the invention by means of the codification notch it is possible to prevent dangerous mix-ups of the Luer connections.
Preferably, the female Luer connector is a female Luer-Lock connector and further comprises one or multiple radially protruding latching elements that are arranged at the collar of the female Luer connector. The one or multiple latching elements are configured in such a way that they may form a form fit with a thread of a male Luer-Lock connector and in particular may rotatably latch with the thread of the male Luer-Lock connector.
Preferably, the codification notch, seen in axial direction, comprises a straight, triangular, rectangular, segment of a circle shaped or trapezoid silhouette. The codification notches of the female Luer connector are preferably inversely shaped to the codification stoppers of the above described male Luer connector. The codification notches are, thus, shaped such that they comprise an inverse or corresponding, respectively, silhouette to the codification parts of the male Luer connector.
Preferably, the collar of the female Luer connector comprises two radial opposingly arranged codification notches. Thereby, a secure codification is ensured such that even in the case of a diagonal mounting of the female Luer connector an unfitting female Luer connector cannot be connected to the male Luer connector.
In a further preferred embodiment the collar of the female Luer connector comprises two asymmetrically arranged codification notches. For particular applications the codification notches can also be arranged asymmetrical or not mirror-inverted, respectively, for example in a 90° angle with respect to each other, at the collar of the female Luer connector. Thereby, no risk of rotation is given for example for a connection between surgery instruments. A defined axial angle position during connection of the female and male Luer connector may also be obtained in the preferred application of only one codification notch or in case of multiple differently shaped codification notches.
The above mentioned problem is also solved by a connection system comprising a male Luer connector as described above and a female Luer connector as described above, wherein the one codification notch or the multiple codification notches of the female Luer connector are inversely shaped to the one codification stopper or the multiple codification stoppers of the male Luer connector.
In the following, the present invention is described in more detail by reference to the accompanying figures, in which shows:
In the following, by reference to the figures, preferred exemplary embodiments of the present invention are described:
Furthermore, the collar 120 comprises two opposing female codification notches 140 that comprise axial in the embodiment of
Furthermore, the conical reception body 110 comprises two radially protruding latching elements 130. These are preferably arranged axially opposing at the collar 120 of the female Luer connector 100 and are conical reduced or slanted to the outside. The latching elements 130 serve to engage into a thread 322 of a male Luer-Lock connector 300 and to prevent any unwanted release with it by a rotation. In case of a Luer connection system 400 comprising a male Luer connector 200 without a thread 322 that is also called a male Luer-Slip connector the latching elements 130 can be omitted.
The female Luer connector 100 comprises furthermore an aperture 150 at the back end of the conical reception body 110 at which for example needles or conduits (not shown) may be connected.
The
Furthermore, the male Luer connector 200 comprises a connection blocking element 230 that is formed in the exemplary embodiment of
In the embodiment of
The male Luer connector 200 can be connected to the fitting codified female Luer connector 100 because the female codification notches 140 and the male codification stoppers 240 are inversely shaped to each other. During the connection, the codification notches 140 of the fitting female Luer connector 100 are passed by on the inner surface 234 of the connection blocking element 230, as can be seen in
A connection of the male Luer connector 200 with a female standard Luer connector is, thus, not possible, because the connection blocking element 230 mechanically prevents this connection. In such a case the female standard Luer connector abuts, during trying to connect, to the codification stoppers 240 of the connection blocking element 230 of the male Luer connector 200 and cannot be moved towards each other any further.
In the cut-view of
The attachment of the connection blocking element 330 on the threaded body 320 can be performed for example by adhering, welding or by friction fit. Then, the male Luer-Lock connector 300 includes the tubular body 310 with the threaded body 320 and the connection blocking element 330 comprising one or multiple codification stoppers 340.
For the establishment of the connection the female Luer connector 100 is passed through the connection blocking element 330 of the male Luer-Lock connector 300 and is in particular passed with its codification notches 140 on the inner surfaces 334 by the codification stoppers 340 of the codification blocking element 330, as can be seen in
The female Luer-Lock connector 100 can be connected to the male Luer-Lock connector 300, because the female codification notches 140 fit to the male codification stoppers 340 with respect to their axial silhouette and are in particular inversely shaped to each other. In case the female codification notches 140 do not fit to the male codification stoppers 340 the female Luer-Lock connector 100 abuts to the two codification stoppers 340 of the male Luer-Lock connector 300 and cannot be connected with it.
The connection is established correspondingly by an axial pushing of the tubular body 210 of the male Luer connector 200 into the reception body 110 of the female Luer connector 100.
This exemplary embodiment can also be realized as a Luer-Lock connection system 400 in which the male Luer connector, a male Luer-Lock connector 300, as described above for the male Luer connector 200, is correspondingly integrally formed with the connection blocking element 230.
Alternatively, the tubular body 310 and the connection blocking element 330 can be integrally formed similar to the exemplary embodiment of
The
Alternatively, the tubular body 210 and the connection blocking element 330 can be integrally formed, similar to the embodiment of
In all of the exemplary embodiments that relate to a Luer connection system 400 comprising a female Luer connector 100 comprising latching elements 130, the male Luer connector 200, 300 may comprise correspondingly one of the shapes of the latching element 130, as for example shown in
Due to the different exemplary embodiments of the present invention a Luer connection system 400 is described exemplarily by which mix-ups between Luer connectors 100, 200, 300 can be effectively prevented and, thus, the safety of patients can be increased significantly in an easy and cost-effective manner.
Number | Date | Country | Kind |
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10 2015 211 370.1 | Jun 2015 | DE | national |
Filing Document | Filing Date | Country | Kind |
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PCT/EP2016/064049 | 6/17/2016 | WO | 00 |