Patent Description:
During medical procedures, operations, administration of drugs or other activities involving medical instruments, it is important that the individual instruments are securely attached together. Instruments which are inadequately connected run the risk of being disconnected, which could potentially expose hazardous medicaments such as cytotoxins, neurotoxins or the like. Further persons dealing with piercing members, e.g. a nurse or a patient, run the risk of being accidentally exposed to the tip of a piercing member which potentially could rupture the skin of a user. The severity of such an incident can range from a low risk level to a substantially lethal risk level, for example when dealing with the HIV virus. However, not only accidents can cause such situations, doctors, nurses, caring personal and even patients can accidentally disconnect the wrong medical instrument. Such an error can potentially impart a high risk situation to the involved persons. There seem to be a need for tamper safe devices and tamper safe connections.

Medical adaptor devices are vital to connect and enable administration of e.g. drugs between vials and syringes or any other medical devices as the range of products, combinations and functions are vast. In the patent with the <CIT> medical instrument arrangement is disclosed. The medical instrument arrangement incorporates a female connector member having a female taper portion and a male connector member having a male taper portion. The female connector member has threads for cooperative engagement with a rotary ring, adapted to rotate freely around the longitudinal axis of the male connector member. The rotary ring further comprises threads for cooperative engagement with the threads of the female connector member. The threads of the rotary ring exhibit a rotary thread ridge which is adapted to fracture a rib arranged on the threads of the female connector member. The fracture of the rib provides for an increased friction between the threads of the female connector member and the threads of the rotary ring, keeping the two connected parts firmly in place and hence substantially tamper safe. There are however drawbacks with this medical instrument arrangement which will be readily apparent.

<CIT> provides for another substantially tamper safe device in the form of a tamper safe closure for a syringe with a luer connection or a luer lock connection. A cap is connected to the syringe via a frangible web which after rupture permits removal of the cap from the syringe. The tamper safe closure does not however provide for any tamper safe means with respect to the device which is connected to the syringe.

<CIT> discloses a needle protection device that can be coupled to a syringe by means of an adaptor forming a coupling between the needle protection device and the syringe. The syringe and the adaptor may be rotated together in relation to the needle protection device to cause breakable tabs in the adaptor to be broken off inside the adaptor, thereby preventing subsequent disengagement of the coupling arrangement. Finally, <CIT> discloses a coupling device comprising the combination of features of the preamble of claim <NUM>.

It is an object of the present invention to at least partly solve some of the above mentioned drawbacks. More specifically they are at least partly solved by a coupling device according to claim <NUM> providing at least a first medical device with a substantially tamper resistant connection. The coupling device or connection arrangement exhibits a centre axis. The connection arrangement comprises a first connection member for connection to the first medical device, and a body. The first connection member and the body are connected directly together via at least one designated ruptureable retaining member, the at least one designated ruptureable retaining member is/are arranged to rupture when subjected to a predetermined breaking force. Wherein the first connection member and thereby the first medical device after assembly can be substantially displaced with respect to the body after rupture. The mentioned breaking force can be a shearing force, a compressive force, tensile force or combinations thereof.

The present invention provides for a substantially tamper resistant connection arrangement which can be used on substantially any medical device for a tamper resistant connection. The tamper resistant connection arrangement eliminates or at least reduces the risk of becoming disconnected from medical devices after it has been connected thereto. Thereby the risk of accidental leakage is significantly reduced and as a direct consequence of this, the environment and work safety for a user is improved as leakage of e.g. toxic drugs can be minimized. These advantages and others will be clear after reading the detailed description below.

In an embodiment according to the present invention, the first connection member is arranged to connect to the at least one first medical device by means of a threaded coupling in a first direction. As such a secure and simple coupling can be provided.

The at least one designated ruptureable retaining member can be arranged to rupture by means of a relative rotational motion subjected to the body with respect to the first connection member. Optionally a longitudinal motion along a centre axis could be used or combinations thereof. However, when using a relative rotational motion, the rupture of the designated ruptureable retaining members can be done by using the same rotational motion as used when connecting the first medical device to the connection arrangement. In this embodiment, the first direction is the same as the direction of the relative rotational motion.

Evaluation of the present invention has shown that the predetermined breaking force should preferably be between <NUM>-<NUM> Ncm, preferably <NUM>-<NUM> Ncm. The breaking force can be a shearing force. This ensures a high enough force, e.g. shear force, to enable a secure and tight connection while at the same time not use too much force to rupture the at least one designated ruptureable retaining member(s). As such the specific numbers of the designated ruptureable retaining members can be adapted so that a specific threshold break force can be obtained. For example <NUM>-<NUM> designated ruptureable retaining members can be used.

In an embodiment, according to the present invention, the at least one designated ruptureable retaining member is/are arranged to provide for a substantially planar fracture surface, to minimize the available friction forces between the body and the first connection member. After rupture it is important that the body and the first connection member can be displaced, for example by being enabled to freely rotate, with respect to each other as easily as possible. This reduces the risk of the first connection member and the body inadvertently engaging each other again, by a temporarily increased friction there between, or for any other reason. The fracture surface created after rupture is advantageously steered to an advantageous position, for example by the at least one designated ruptureable retaining member comprises at least one notch, an example of a suitable notch can be a groove in the designated ruptureable retaining member, a weak point, a fold or combinations thereof.

According to the present invention, the first connection member and at least a part of the body together form a first connection site to which the first medical device can be connected. This is very advantageous when the connection arrangement is of luer-lock type, for example a female luer lock or a male luer lock connection. The first connection member has a substantially cylindrical form and is therefore also referred to as cylinder member. As such, the cylindrical form car at least partly enclose the body which then forms a part of the first connection site to enable a liquid tight seal there between.

The at least one designated ruptureable retaining member is integrally formed with at least the first connection member, i.e. the cylinder member, and the body. Either way, the at least one designated ruptureable retaining member can be integrally formed with the members which after rupture are intended to be displaced, e.g., freely rotateable, with respect to each other. This enables the member to be manufactured in one piece, for instance by form moulding. Optionally, and not according to the invention, the at least one designated ruptureable retaining member is manufactured from a separate piece, which enables a large variety of the property of the at least one designated ruptureable retaining member, combinations thereof are of course also possible.

According to the present invention, the supportive housing comprises means for substantially preventing the first connection member from motion along the centre axis A. The connection arrangement can comprise a second connection site for connecting to a second medical device. The second connection site can be a part of the body or separate therefrom, for example positioned on a part of a piercing member protection device to which the connection arrangement, according to the present invention, can be arranged. Hence it is well within the boundaries of the present invention that the connection arrangement forms part of a medical adaptor device, a piercing member protection device, a syringe, an infusion bag connection system, or any other medical device.

The present invention further relates to a method for attaching a first medical device to a connection arrangement, according to the present invention, to form a substantially tamper resistant connection therebetween. The connection arrangement comprises a first connection member and a body. The method comprises the steps of;.

The present invention relates to a female and a male coupling device.

Such a coupling device has a centre axis and is arranged for connection with at least a first medical device. The coupling device comprises a first connection site comprising a cylinder member having threads for providing a threaded coupling with a first medical device by means of a rotational motion in a first direction. The cylinder member comprises an inner and an outer surface. The coupling devices further exhibit a fluid transfer channel for enabling a fluid connection, wherein the cylinder member is arranged to at least partly encompass the fluid transfer channel. The fluid transfer channel extends inside of a body. The cylinder member is directly connected to the body via at least one designated ruptureable retaining member, wherein the at least one designated ruptureable retaining member is/are arranged to rupture when subjected to a predetermined breaking force whereafter the cylinder member can be displaced, for example to be freely rotated around the centre axis, and with respect to the body. Such a coupling device provides for a tamper resistant coupling device which can advantageously be used for e.g. transferring toxic fluids since there is no or limited risk of disconnection as e.g. the rotational motion needed for disconnection has been effectively disabled.

The female or male coupling device comprises means for substantially preventing the cylinder from motion in a direction along the centre axis A, the means is a supportive housing arranged to hold the cylinder in position.

In an embodiment, the female or male coupling device is a male coupling device and in that the threads of the cylinder member are arranged on the inner surface of the cylinder member. Such a coupling device is arranged to receive a female coupling device in the cylinder member.

According to the present invention, the at least one designated ruptureable retaining member is/are arranged to rupture when subjected to a rotational motion to the cylinder member and in that the imparted rotational motion is in the same direction as the first direction. This provides for the same advantages as mentioned above.

The designated ruptureable retaining members can be positioned in many different places. Generally the manufacturing methods determine the positioning. The cylinder member comprises a first and a second end and the at least one designated ruptureable retaining member is/are arranged at the first end of the cylinder member. This has been found to be advantageous from manufacturing point of view. The female or male coupling device as described above can be of a luer lock type connection.

The present invention also relates to a medical adaptor device, a piercing member protection device, a syringe, preferably a disposable syringe, an infusion bag connection system, or any other medical device having a connection arrangement as described above.

By the term "medical device" as used in this document is meant any device which is suitable to use in a hospital environment, care taking environment, nursing institutions or the like, more preferably it is meant devices used in a hospital like environment requiring quality secured devices.

The present invention will hereafter be described in greater detail and with reference to the accompanying figures in which;.

The present invention will be described in greater detail and in a non limiting way with reference to the enclosed embodiments. <FIG> shows a connection arrangement <NUM> having a centre axis A, according to a first embodiment of the present invention, in the form of a medical adaptor device <NUM> for connecting to a syringe, a vial or any other medical device having a luer lock connection, and e.g. a medical device from the Carmel Pharma™ product range, using a double membrane coupling. A medical device using a double membrane coupling is described in the publication of <CIT>.

The medical adaptor device <NUM> comprises a second connection site <NUM> for connecting with a medical device via a membrane coupling <NUM> having a neck element <NUM> and a first and a second guiding groove <NUM>, <NUM> for guiding corresponding parts of a membrane coupling between a locked position and an unlocked position with a rotational motion. A barrier member <NUM> provides for a gas and liquid tight seal around a piercing member which during use is intended to be inserted into the barrier member <NUM> to e.g. administrate drugs. The medical adaptor <NUM> further comprises a first connection site <NUM> to connect to e.g. an injection port or a port an infusion bag, via a luer lock type connection <NUM>. A supportive housing <NUM> is arranged to structurally support at least the second connection site <NUM>.

<FIG> shows the first and the second connection sites <NUM>, <NUM> and a body <NUM>, shown without the barrier member <NUM>. The first connection site <NUM>, i.e. the luer lock type connection, comprises a female cylinder <NUM> with an inner surface <NUM> and an outer surface <NUM>, female in the sense that the female cylinder <NUM> is arranged to receive a male counterpart. The inner surface <NUM> of the female cylinder <NUM> exhibit threads <NUM> as shown in <FIG>. The female cylinder <NUM> has an upper and lower edge <NUM>, <NUM>. As can be seen a male tapered connection part <NUM> can be seen extending past the lower edge <NUM> of the female cylinder <NUM>, as such, the first connection site <NUM> is generally referred to as a male luer-lock. At least partly defining the upper edge <NUM> of the female cylinder <NUM> of the first connection site <NUM> is a groove <NUM> extending around the periphery of the female cylinder <NUM> and extending through the width of the wall of the female cylinder <NUM>. Four designated ruptureable retaining members <NUM> (only two of which are shown in <FIG>) hold the female cylinder <NUM> is a fixed position with respect to the second connection site <NUM> and the body <NUM>. The female cylinder <NUM> further; comprises, is arranged to, or is optionally in working cooperation with means for preventing the female cylinder <NUM> from motion along the centre axis A and especially in a direction away from the second connection site <NUM>. In the shown embodiment, according to the present invention, the means comprises a stop flange <NUM> arranged in the proximity of the second end <NUM> of the female cylinder <NUM> and extending around the periphery of the female cylinder <NUM>, and which is arranged in working cooperation with the supportive housing <NUM>, as shown in <FIG>.

<FIG> further show two of the four designated ruptureable retaining members <NUM> positioned symmetrically around the centre axis A at <NUM>° intervals. Each of the four designated ruptureable retaining members <NUM> are adapted to rupture when subjected to a predetermined shear force subjected to the designated ruptureable retaining members <NUM> preferably after the assembly with a first medical device, and preferably with a substantially planar fracture surface so that the friction forces between the body <NUM> and the female cylinder <NUM> is kept as low as possible to prevent the first medical device being unscrewed.

The form and shape of the designated ruptureable retaining members <NUM>, and for the sake of the present invention, any at least one designated ruptureable retaining member(s), is preferably adapted to provide a fracture surface which minimizes the friction between the rotating parts, in the shown embodiment of <FIG>, between the female cylinder <NUM> and the body <NUM>. This can preferably be done by providing the designated ruptureable retaining members with a notch to steer the location of the fracture surface. This is also preferable for all the embodiments described hereafter. In the embodiment, according to the present invention, shown in <FIG>, the designated ruptureable retaining members <NUM> are formed having a tilting surface <NUM>, tilting towards the first end <NUM> of the female cylinder <NUM>. In this case, the notch is tangential to the first end <NUM> of the female cylinder <NUM>, providing a fracture surface at the first end <NUM> of the female cylinder <NUM>. Furthermore, the manufacturing material is preferably chosen so that the fracture surface is substantially parallel with the first end <NUM> of the female cylinder <NUM> to minimize the friction there between. The tilting surface <NUM> is preferably arranged so that it provides for a slope towards the unscrewing direction to reduce the friction formed between the female cylinder <NUM> and the body <NUM>. This is of course applicable to all embodiments herein.

<FIG> show the supportive housing <NUM> in greater detail and separated from the other parts of the medical adaptor device <NUM> for the sake of clarity. The supportive housing <NUM> has a substantially cylindrical form having an upper and a lower end, equivalent to a first and a second end <NUM>, <NUM> and an inner and an outer surface <NUM>, <NUM>. A plurality of, in this embodiment four, wedge like protrusions <NUM> extend out from the inner surface <NUM> of the supportive housing <NUM> in the proximity of the first end <NUM>, although only two wedge like protrusions <NUM> are shown in <FIG>. The wedge like protrusions <NUM> have a tapering surface, tapering towards the first end <NUM> of the supportive housing <NUM>. At the second end <NUM> of the supportive housing <NUM> is a circumferential stop flange <NUM>, which extends around the inner surface <NUM> and protrudes towards the centre axis A. The purpose of the circumferential stop flange <NUM> and the wedge like protrusions <NUM> will be described in greater detail below.

<FIG> shows a cross section of the medical adaptor device <NUM> shown in <FIG>. More specifically, <FIG> shows the second connection site <NUM> with the barrier member <NUM>, the first connection site <NUM> and a fluid channel <NUM> extending there between. A body <NUM> defines the fluid channel <NUM> and the male tapered connection part <NUM> as can be seen extending past the lower edge <NUM> of the female cylinder <NUM>. The supportive housing <NUM> encloses the female cylinder <NUM> of the first connection site <NUM>. During assembly, the supportive housing <NUM> is slid onto the female cylinder <NUM> until the wedge like protrusions <NUM> snap onto a lock flange <NUM>, which extends around the periphery of the body <NUM>. The wedge like protrusions <NUM> and the lock flange <NUM> of the body <NUM> prevent the supporting housing <NUM> from movement along the centre axis A. In addition, the second connection site <NUM> can be arranged to be positioned adjacent the upper end <NUM> of the supportive housing <NUM> to prevent the supportive housing from movement along the centre axis A, at least in one direction. As can further be seen in <FIG>, the circumferential stop flange <NUM> of the supportive housing <NUM> is, after assembly, positioned substantially adjacent the corresponding stop flange <NUM> of the female cylinder <NUM>. Optionally part of the second end <NUM> of the female cylinder <NUM> can be used to cooperate with the circumferential stop flange <NUM>.

The supportive housing <NUM> permits the female cylinder to rotate around the centre axis A, after the designated ruptureable retaining members <NUM> are ruptured. It further keeps the female cylinder <NUM> from motion in the longitudinal direction of the centre axis A. This enables the medical adaptor device <NUM> to be tamper resistant in the meaning of that any device which is attached with the medical adaptor device <NUM> can, after the at least one designated ruptureable retaining member is/are ruptured, freely rotate. In practice, the effect of this is that the second connection site <NUM> uses a rotational motion to fasten a medical device, for the sake of this example; an injector. The same rotational motion can be used to rupture the designated ruptureable retaining members <NUM> whereafter the friction between the female cylinder <NUM> and the body <NUM> and the supportive housing <NUM> is so low that a counter rotational motion does not unscrew the injector. This function and effect will be described in greater detail with reference to <FIG>.

<FIG> show the medical adaptor device <NUM> as shown in <FIG> and <FIG> after connection with a female catheter connection part <NUM>. The female catheter connection part <NUM> has been screwed onto the threads <NUM> of the female cylinder <NUM> until the male tapered connection part <NUM> of the body <NUM> engages the inner surface <NUM> of the female catheter connection part <NUM>. When continuing the rotational motion, i.e. the threading, the friction between the male tapered connection part <NUM> and the inner surface <NUM> of the female catheter connection part <NUM> is sufficiently high to provide for a good connection and a substantially liquid tight seal therebetween. As the rotational motion is continued, the designated ruptureable retaining members <NUM> rupture. As can be seen in <FIG>, the designated ruptureable retaining members <NUM> are formed integrally with the body <NUM> and the female cylinder <NUM> of the medical adaptor device <NUM>, for example by form molding with a termoplastic material. In other embodiments, which are not according to the present invention, the at least one designated ruptureable retaining member(s) <NUM> can be made from different material(s), combinations of integrally formed designated ruptureable retaining members <NUM> and designated ruptureable retaining members <NUM> made from different materials are of course also possible, each embodiment having its own advantage. For instance, if the medical connector device is manufactured from a metal material it might be advantageous to have the designated ruptureable retaining members <NUM> manufactured in a termoplastic material.

Further, the at least one designated ruptureable retaining member(s) can be manufactured from a substantially elastic material. This could be advantageous since a user could be warned or informed of when the designated ruptureable retaining members <NUM> are about to break by an indication on the connector, in this case the medical adaptor device <NUM>, corresponding to the required rotational distance before rupture, which can be calculated or evaluated.

<FIG> shows the female catheter connection part <NUM> after being connected to the luer lock type connection of the medical adaptor device <NUM>. The female catheter connection part <NUM> can now be connected to a medical device having a double membrane bayonet coupling via the medical adaptor device <NUM>. As can further be seen, the designated ruptureable retaining members <NUM> have ruptured, thereby permitting the female cylinder <NUM> to be freely rotated around the centre axis A, while being substantially prevented from motion in a longitudinal direction of the centre axis A, i.e. in a motion along the centre axis A. As the female cylinder <NUM> can be freely rotated, the second connection site <NUM> can also be freely rotated, with respect to the first connection site <NUM>, i.e. the luer lock connection and the female catheter connection part <NUM>. Hence, the medical adaptor device <NUM> in principle cannot be removed from the female catheter connection part <NUM>.

It is further notable that the risk of leakage between the inner surface <NUM> of the female catheter connection part <NUM> and the male tapered connection part <NUM> is very low. In fact, the male tapered connection part <NUM> can be rotated inside of the female catheter connection part <NUM> without leakage. Should it be desirable for any reason to further improve the leakage preventive properties of the medical adaptor device <NUM>, the medical adaptor device <NUM> can be provided with at least one leakage barrier, preferably in the near proximity of the root of the male tapered connection part <NUM>, such as an O-ring, which after assembly is intended to be positioned adjacent the attached medical device, in the shown embodiment, the top of the female catheter connection part <NUM>. The connection arrangement <NUM>, in this case the medical adaptor device <NUM>, can be coated with a leakage preventing coating such as a silicone based coating. In this case the coating would be applied onto the male tapered connection part <NUM>.

It is further notable that the supportive housing <NUM> can be arranged with means to prevent it from rotation with respect to the second connection site <NUM>. Such means may be in the form of a protrusion and a corresponding groove. This feature would improve the handling of the medical adaptor device <NUM> by providing a larger grip area.

A second embodiment will be further described which is not an embodiment of the present invention. In this embodiment, the connection arrangement <NUM> is applied to a piercing member protection device <NUM> for providing at least a first medical device with a substantially tamper resistant connection. Suitable piercing member protection device which can be utilized is disclosed in the patent application publication of <CIT> in the name of Carmel Pharma AB.

<FIG> shows the piercing member protection device <NUM> with a longitudinal centre axis A extending in the longitudinal direction of the piercing member protection device <NUM> and in the centre of the piercing member protection device <NUM>. Generally the piercing member protection device <NUM> exhibits a first cylindrical member <NUM> which is at least partly encompassed by a second cylindrical member <NUM>, which in turn is at least partly encompassed by a third cylindrical member <NUM>. A piercing member (not shown) is connected to the third cylindrical member <NUM> and extends into a protection chamber defined by the interior of the first cylindrical member <NUM>. A first barrier member <NUM>, which after connection with a connection port on e.g. an infusion bag is intended to provide a double membrane coupling, seals the protection chamber of the first cylindrical member <NUM> to provide a closed environment for at least the tip of the piercing member of the piercing member protection device <NUM>. This position is also referred to as the unexposed state, as the piercing member is unexposed inside the protective chamber.

A first locking arrangement <NUM> is provided between the first cylindrical member <NUM> and the second cylindrical member <NUM>. The first locking arrangement <NUM> can be arranged in a first position in which the first cylindrical member <NUM> is enabled to be turned with respect to the second cylindrical member <NUM> and a second position in which the first cylindrical member <NUM> is disabled form turning with respect to the second cylindrical member <NUM>. The second locking device can be alternated between the first and the second position by means of connecting the piercing member protection device <NUM> to the connection port.

A second locking arrangement provides a first position in which the piercing member, and the third cylindrical member <NUM>, is enabled to move along the centre axis A with respect to the first barrier member <NUM>, and a second position in which the piercing member, and the third cylindrical member <NUM>, is prevented from moving along the longitudinal centre axis A with respect to the first barrier member <NUM>. The second locking arrangement <NUM> is alternated between the first position and the second position by means of turning the first cylindrical member <NUM> and the third cylindrical member <NUM> with respect to the second cylindrical member <NUM>. As the piercing member is moved along the longitudinal centre axis A it can be moved to an exposed state at which parts of the piercing member are exposed outside of the protective chamber and the first barrier member <NUM>, for example in order to transfer a drug from a vial to a syringe. The second locking arrangement is enabled by an L-shaped groove on the third cylindrical member <NUM> and a corresponding protrusion on the second cylindrical member <NUM>.

As can further be seen in <FIG>, the third cylindrical member <NUM> comprises a first connection site <NUM> having a threaded female connection part <NUM> for connection with a male luer lock connection on e.g. a syringe. The first connection site <NUM> is connected to the third cylinder member <NUM> via at least one ruptureable retaining member <NUM>, in the shown embodiment of <FIG>, five designated ruptureable retaining members <NUM>, although only four can be seen. This permits the first connection site <NUM> to freely rotate around the centre axis A, after the designated ruptureable retaining members <NUM> are ruptured. It further prevents the first connection site <NUM> from motion in the longitudinal direction of the centre axis A. This enables the piercing member protection device <NUM> to be tamper resistant in the meaning of that any device which is attached to the piercing member protection device <NUM> can, after the at least one designated ruptureable retaining member is/are ruptured, freely rotate. In practice, the effect of this is that since the first connection site <NUM> uses a rotational motion to fasten a medical device, for the sake of this example; a syringe. The same rotational motion can be used to rupture the designated ruptureable retaining members <NUM> whereafter the friction between the first connection site <NUM> and the third cylinder member <NUM> is so low that a counter rotational motion does not unscrew the medical device, in this case a syringe.

In the embodiment shown in <FIG>, the designated ruptureable retaining members <NUM> are assembled to the piercing member protection device <NUM> via a ring body <NUM> having an inner and an outer ring member <NUM>, <NUM>, as seen in greater detail in <FIG>. By the terms inner and outer rings, is meant with reference to the centre axis A. <FIG> shows further that the outer ring member <NUM> comprises a plurality of deformable lock flanges <NUM> which are arranged to, during assembly, deform so that the deformable lock flanges <NUM> can be positioned to engage and lock the ring body <NUM> to the third cylinder member <NUM> at a plurality of corresponding lock grooves <NUM> (shown in <FIG>). Each deformable lock flange <NUM> comprises a lock protrusion extending from the distal end of the deformable lock flanges <NUM> towards the centre axis A.

The ring body <NUM> also exhibits a first and a second end <NUM>, <NUM>, equivalent to the upper and the lower end <NUM>, <NUM> as seen in <FIG>. In the near proximity of the first end <NUM> of the ring body <NUM>, five designated ruptureable retaining members <NUM> attach the inner ring member <NUM> to the outer ring member <NUM> preventing the inner ring member <NUM> from substantially any motion with respect to the outer ring member <NUM> before the designated ruptureable retaining members <NUM> are ruptured by a predetermined shear force. Each of the designated ruptureable retaining members <NUM> exhibit a tilting surface <NUM> serving the purpose of reducing the friction forces and minimizing the risk for reengagement of the fractured parts, between the inner and outer ring member <NUM>, <NUM> after the designated ruptureable retaining members <NUM> have been ruptured. The designated ruptureable retaining members <NUM> are made integrally with the cylindrical body <NUM>. However, as mentioned earlier, they can be made from different materials or combinations thereof.

The inner ring <NUM> comprises attachment flanges <NUM> to provide a snap on connection between the first connection site <NUM> and the inner ring <NUM>. <FIG> shows the first connection site <NUM> in greater detail. As can be seen, the first connection site <NUM> comprises a threaded female connection part <NUM> equipped with threads <NUM> for a rotational connection with a medical device (not shown) such as a syringe. The threaded female connection part <NUM> comprises a distal end <NUM> and a proximal end <NUM>. The proximal end <NUM> of the threaded female connection part <NUM> is arranged on a cylindrical base <NUM> having a first and a second locking flange <NUM>, <NUM> for providing a snap on connection with the inner ring <NUM> and the corresponding attachment flanges <NUM>. Furthermore, the cylindrical base <NUM> comprises a circumferential channel <NUM> extend around the periphery of the cylindrical base <NUM> permitting, after assembly, free rotation of the cylindrical base <NUM> with respect to the third cylinder <NUM> of the piercing member protection device <NUM>.

As is noticed, the cylindrical base <NUM> and the inner ring member <NUM> of the ring body <NUM> forms the body while the outer ring <NUM> and optionally the third cylinder member <NUM> forms a first connection member.

<FIG> shows the third cylinder member <NUM> in greater detail without any other components attached. As can be seen, the third cylinder member <NUM> comprises a plurality of lock grooves <NUM> for connection with the ring body <NUM> and the deformable lock flanges <NUM> of the outer ring <NUM> of the ring body <NUM>. Wedge like protrusions <NUM> are arranged on the inside of the third cylinder member <NUM> in the proximity of an upper end <NUM> of the third cylinder member <NUM>, and extending towards the centre axis A enabling a snap on connection with the circumferential channel <NUM> of the cylinder base <NUM>.

<FIG> shows a cross section of the third cylinder member <NUM>, the ring body <NUM> and the first connection site <NUM> after assembly and before rupture of the designated ruptureable retaining members <NUM>. An infusion tube <NUM> is threaded onto the threaded female connection part <NUM> of the first connection site <NUM>. As the infusion tube <NUM> is connected by a rotational motion, the luer lock connection provides for a liquid tight seal between the first connection site <NUM> and the infusion tube <NUM>. As the rotational motion continues, the connection is tightened and a predetermined threshold of stress, in this case about <NUM> Ncm, the shear force imparted from the infusion tube <NUM> ruptures the designated ruptureable retaining members <NUM> of the cylindrical body <NUM>. As the designated ruptureable retaining members <NUM> of the cylindrical body <NUM> rupture, the inner ring <NUM> of the cylindrical body <NUM> is permitted to freely rotate around the centre axis A, disabling any attempts to disconnect the infusion tube <NUM>.

In a third embodiment that is not an embodiment of the present invention, the connection arrangement is utilized on an infusion bag connection system <NUM> for a tamper resistant connection to an infusion bag <NUM>. As is seen in <FIG>, the infusion bag connection system <NUM> comprises a second connection site <NUM>, as described earlier with reference to <FIG> and <FIG>. That is, a body, a first connection member <NUM>, in the form of a female cylinder <NUM> having a threaded inner surface <NUM>, is fixedly connected to the body <NUM> by means of at least one designated ruptureable retaining member, which after subjected to a predetermined shear force is arranged to rupture. After rupture the female cylinder <NUM> can be freely rotated around the centre axis A with respect to the body <NUM>. A fluid transfer channel <NUM> is arranged in the body <NUM>.

As has been shown, the connection arrangement <NUM> according to present invention can advantageously be used as a male luer lock connection. Additionally the connection arrangement <NUM> can be used on, i.e. as the connection arrangement on a medical device e.g. a syringe, such as a disposable syringe, a medical fluid container, a medical waste container or the like.

It is also within the boundaries of the present invention that the connection arrangement <NUM> is used as a female luer lock connection. <FIG> shows a disposable syringe (only a part of the syringe is shown for the sake of clarity and without its plunger). <FIG> shows a cross section of a syringe <NUM> with a centre axis A and adapted for a tamper resistant connection with a first medical device, such as a piercing member protection device. <FIG> shows the syringe as seen in perspective. The syringe <NUM> is preferably of the disposable type.

With reference to both <FIG>, the syringe <NUM> comprises a fluid housing <NUM> in which drugs can be temporarily contained before administration trough a dispensing opening <NUM>, arranged in the end of the fluid housing <NUM>. The fluid housing <NUM> further comprises a second opening (not shown) through which a plunger can be inserted for volumetric control of the fluid housing. The dispensing opening <NUM> comprises a dispensing channel housing <NUM> with a dispensing channel and with a slightly tapered inner surface <NUM>, so as to be able to tightly mate with the male tapered connection part of a male luer lock connection, see for example the male tapered connection part <NUM> in <FIG> or <FIG>. The dispensing channel housing <NUM> exhibit a distal end <NUM>, and a proximal end <NUM> wherein the proximal end is arranged on the fluid housing <NUM> of the syringe <NUM>.

A cylinder <NUM> having an outer and an inner surface <NUM>, <NUM> and a first and a second end <NUM>, <NUM> is arranged on the dispensing channel housing <NUM>. The outer surface <NUM> facing away from the centre axis A. Threads <NUM> are arranged on the outer surface <NUM> of the cylinder <NUM> for connection with a male luer lock connection. The distal end <NUM> of the dispensing channel housing <NUM> comprises a circumferential lock flange <NUM> to substantially prevent the cylinder <NUM> from motion in a direction along the centre axis A, at least in a direction away from the fluid housing <NUM>, the fluid housing <NUM> being a natural stop in the other direction.

As is noted, the dispensing channel housing <NUM> forms together with the fluid housing <NUM> a body while the cylinder <NUM> forms a first connection member. A connection site <NUM> is formed by the dispensing channel housing <NUM> and the cylinder <NUM>.

The cylinder <NUM> is attached to the circumferential lock flange <NUM> via a plurality of designated ruptureable retaining members <NUM>. The designated ruptureable retaining members <NUM> prevent the rotation of the cylinder <NUM> with respect to the fluid housing <NUM> and thereby enabling the connection to a male luer lock connection. As the syringe is screwed on to the medical device and a tight connection is reached, the threshold shear force of each of the designated ruptureable retaining members <NUM> is surpassed, fracturing the ruputureable retaining members <NUM>. As the designated ruptureable retaining members rupture, the cylinder <NUM> of the syringe <NUM> can rotate freely, with respect to the fluid housing <NUM> of the syringe, without risking that the syringe and the medical device is disconnected.

The fluid housing <NUM>, the designated ruptureable retaining members <NUM>, the cylinder <NUM>, the circumferential lock flange <NUM> and the dispensing channel housing <NUM> can be formed integrally from the same material. Optionally, the designated ruptureable retaining members can be formed from another material; the cylinder <NUM> can be e.g. adhered to the dispensing channel housing <NUM> to form the designated ruptureable retaining members.

In the embodiments described above the rupture of the designated ruptureable retaining members is accomplished by a rotational motion in the same rotational direction as the connection of the first medical device. One major advantage of using this configuration of the connection arrangement, according to the present invention, is of course that it disables any attempt to counter-rotate the medical device after the designated ruptureable retaining members are ruptured. However, it is well within the boundaries of the present invention that the rupture of the designated ruptureable retaining member(s) can be done by means of pressing, pulling, tilting or otherwise manipulating e.g. the connected first medical device. The triggering mechanism for rupturing the designated ruptureable retaining member(s) are in some embodiments less relevant, although the rotational triggering is preferable since it can be combined with a rotational attachment of a medical device. Furthermore, the connection of the first medical device does not have to be by a rotational motion, instead is it possible to use e.g. a snap on connection.

Claim 1:
A female or a male coupling device having a centre axis A for connection with at least a first medical device, said coupling device comprising a connection site (<NUM>) comprising;
a cylinder member (<NUM>) having threads (<NUM>) for providing a threaded coupling with a first medical device by means of a rotational motion in a first direction, said cylinder member (<NUM>) comprising an inner and an outer surface (<NUM>, <NUM>),
a fluid transfer channel (<NUM>) for enabling a fluid connection, wherein said cylinder member (<NUM>) is arranged to at least partly encompass said fluid transfer channel (<NUM>), and
a body (<NUM>), said fluid transfer channel extending inside of said body (<NUM>),
wherein said coupling device further comprises a supportive housing (<NUM>), wherein said cylinder member (<NUM>) is connected to said body (<NUM>) via at least one designated ruptureable retaining member (<NUM>) integrally formed with the body, wherein said at least one designated ruptureable retaining member (<NUM>) is arranged to rupture at a predetermined rotational breaking force around said centre axis A whereafter said cylinder member (<NUM>) can be freely rotated around said centre axis (A) and with respect to said body (<NUM>) and wherein said supportive housing (<NUM>) prevents said cylinder member (<NUM>) from motion in a direction along said centre axis A, characterized in that said at least one designated ruptureable retaining member (<NUM>) is further integrally formed with said cylinder member (<NUM>).