Abstract:
The present invention relates to a connection arrangement and a method of assembly, for providing a substantially tamper resistant connection with at least a first medical device. The connection arrangement ( 1 ) having a centre axis (A), the connection arrangement ( 1 ) comprises; a first connection member ( 21,161,521,621 ) for connection to the first medical device by means of a rotational motion in a first direction, and a body ( 60,120, 504, 603 ). Additionally the first connection member ( 21,161,521,621 ) and the body ( 60,120, 504, 603 ) are connected directly or indirectly together via at least one designated ruptureable retaining member ( 41, 141, 541, 641 ), the designated ruptureable retaining member ( 41, 141, 541, 641 ) is arranged to rupture at a predetermined breaking force, wherein the first connection member ( 21,161,521,621 ), and thereby the first medical device after assembly, can be displaced with respect to the body ( 60,120, 504, 603 ) after rupture. The present invention provides for a substantially tamper safe connection arrangement which disables accidents such as wrongly disengage a connected medical device. A safer handling is provided for the involved user(s).

Description:
TECHNICAL FIELD 
       [0001]    The present invention relates to a connection arrangement for providing at least one medical device with a tamper resistant connection and a method for connecting the at least one medical device to the connection arrangement. 
       BACKGROUND OF THE INVENTION 
       [0002]    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. 
         [0003]    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 U.S. Pat. No. 4,629,455 a 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. 
         [0004]    US 2004/016858 A1 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. 
       SUMMARY OF THE INVENTION 
       [0005]    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 connection arrangement providing at least a first medical device with a substantially tamper resistant connection. The connection arrangement may exhibit 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 or indirectly 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. 
         [0006]    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. 
         [0007]    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. 
         [0008]    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. 
         [0009]    Evaluation of the present invention has shown that the predetermined breaking force should preferably be between 10-40 Ncm, preferably 15-30 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 1-10 designated ruptureable retaining members can be used. 
         [0010]    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. 
         [0011]    In yet an embodiment, 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. Usually in these cases, optionally in others, it is advantageous that the first connection member has a substantially cylindrical form. As such, the cylindrical form can at least partly enclose the body which then forms a part of the first connection site to enable a liquid tight seal there between. 
         [0012]    The at least one designated ruptureable retaining member can be integrally formed with at least the first connection 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, 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. 
         [0013]    In an embodiment, according to the present invention, the body comprises means for substantially preventing the first connection member from motion along the centre axis A. These means can be a supportive housing, a circumferential groove which is intended to be assembled with a lock flange, for instance a wedge like protrusion, as is described in greater detail below. 
         [0014]    In an embodiment according to the present invention, the first connection member comprises a first connection site to which the first medical device can be connected. In contrary to when the first connection member forms part of a first connection site together with the body, this embodiment may have a first connection site arranged on the first connection member. In this embodiment, the connection function to the first medical device and the first connection member are separated from each other, enabling a different use, for instance as is shown and described with reference to  FIGS. 6-10  below. 
         [0015]    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. 
         [0016]    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;
       attaching the first medical device to the first connection member by means of a motion in a first direction;   rupturing at least one designated ruptureable retaining member arranged between the first connection member and the body, by means of subjecting the at least one designated ruptureable retaining member(s) with a breaking force, so that the first connection member and the body can be displaced, e.g. freely rotated, with respect to each other. The at least one designated ruptureable retaining member can optionally be ruptured by means of a rotational motion, preferably in the first direction. The method provides for a safe and accurate way of connecting a first medical device to a connection arrangement, for example used on a medical adaptor device, piercing member protection device or any other medical device. As such the present invention also relates to such devices.       
 
         [0019]    The present invention also 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 or indirectly 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. 
         [0020]    The female or male coupling device may comprise means for substantially preventing the cylinder from motion in a direction along the centre axis A, for example, the means may be a supportive housing arranged to hold the cylinder in position. 
         [0021]    In an embodiment, the coupling device is a female coupling device and the threads of the cylinder member are arranged on the outer surface of the cylinder member. This is very useful on e.g. a syringe, such as a disposable syringe. Such a coupling device is arranged to receive a male coupling device outside on the cylinder member. 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. 
         [0022]    In an embodiment 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. 
         [0023]    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. 
         [0024]    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. 
       DEFINITIONS 
       [0025]    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. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0026]    The present invention will hereafter be described in greater detail and with reference to the accompanying figures in which; 
           [0027]      FIG. 1  shows a medical adaptor device having a connection arrangement according to an embodiment of the present invention; 
           [0028]      FIG. 2  shows parts of the medical adaptor device as seen in  FIG. 1 ; 
           [0029]      FIG. 3   a  shows the supportive housing of the medical adaptor as seen in  FIG. 1 ; 
           [0030]      FIG. 3   b  shows a cross section of the supportive housing as seen in  FIGS. 1 and 3   a;    
           [0031]      FIG. 4  shows a cross section of the medical adaptor device as shown in  FIG. 1 ; 
           [0032]      FIG. 5   a  shows a cross section of the medical adaptor device as shown in  FIG. 1  after connection with a female catheter connection part; 
           [0033]      FIG. 5   b  shows a cross section of the medical adaptor device as shown in  FIG. 5   a  after connection with a female catheter connection part and after rupture of the designated ruptureable retaining members; 
           [0034]      FIG. 6  shows a piercing member protection device having a connection arrangement according to an embodiment of the present invention; 
           [0035]      FIG. 7-9  shows the parts of the piercing member protection device as seen on  FIG. 6  in greater detail; 
           [0036]      FIG. 10  shows parts of the piercing member protection device after assembly with a tube and; 
           [0037]      FIG. 11  shows parts of an infusion bag connection system having a connection arrangement according to an embodiment of the present invention and; 
           [0038]      FIG. 12   a - 12   b  shows a disposable syringe having a connection arrangement according to an embodiment of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0039]    The present invention will be described in greater detail and in a non limiting way with reference to the enclosed embodiments.  FIG. 1  shows a connection arrangement  1  having a centre axis A, according to a first embodiment of the present invention, in the form of a medical adaptor device  10  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 WO 2008/115102A1. 
         [0040]    The medical adaptor device  10  comprises a second connection site  11  for connecting with a medical device via a membrane coupling  12  having a neck element  13  and a first and a second guiding groove  14 ,  15  for guiding corresponding parts of a membrane coupling between a locked position and an unlocked position with a rotational motion. A barrier member  16  provides for a gas and liquid tight seal around a piercing member which during use is intended to be inserted into the barrier member  16  to e.g. administrate drugs. The medical adaptor  10  further comprises a first connection site  20  to connect to e.g. an injection port or a port an infusion bag, via a luer lock type connection  20 . A supportive housing  30  is arranged to structurally support at least the second connection site  20 . 
         [0041]      FIG. 2  shows the first and the second connection sites  20 ,  11  and a body  60 , shown without the barrier member  16 . The first connection site  20 , i.e. the luer lock type connection, comprises a female cylinder  21  with an inner surface  22  and an outer surface  23 , female in the sense that the female cylinder  21  is arranged to receive a male counterpart. The inner surface  22  of the female cylinder  21  exhibit threads  25  as shown in  FIGS. 4-5 . The female cylinder  21  has an upper and lower edge  26 ,  27 . As can be seen a male tapered connection part  28  can be seen extending past the lower edge  27  of the female cylinder  21 , as such, the first connection site  20  is generally referred to as a male luer-lock. At least partly defining the upper edge  26  of the female cylinder  21  of the first connection site  20  is a groove  40  extending around the periphery of the female cylinder  21  and extending through the width of the wall of the female cylinder  21 . Four designated ruptureable retaining members  41  (only two of which are shown in  FIG. 2 ) hold the female cylinder  21  is a fixed position with respect to the second connection site  11  and the body  60 . The female cylinder  21  further; comprises, is arranged to, or is optionally in working cooperation with means for preventing the female cylinder  21  from motion along the centre axis A and especially in a direction away from the second connection site  11 . In the shown embodiment, according to the present invention, the means comprises a stop flange  29  arranged in the proximity of the second end  27  of the female cylinder  21  and extending around the periphery of the female cylinder  21 , and which is arranged in working cooperation with the supportive housing  30 , as shown in  FIG. 1 . 
         [0042]      FIG. 2  further show two of the four designated ruptureable retaining members  41  positioned symmetrically around the centre axis A at 90° intervals. Each of the four designated ruptureable retaining members  41  are adapted to rupture when subjected to a predetermined shear force subjected to the designated ruptureable retaining members  41  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  60  and the female cylinder  21  is kept as low as possible to prevent the first medical device being unscrewed. 
         [0043]    The form and shape of the designated ruptureable retaining members  41 , 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. 2 , between the female cylinder  21  and the body  60 . 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. 2 , the designated ruptureable retaining members  41  are formed having a tilting surface  42 , tilting towards the first end  26  of the female cylinder  21 . In this case, the notch is tangential to the first end  26  of the female cylinder  21 , providing a fracture surface at the first end  26  of the female cylinder  21 . Furthermore, the manufacturing material is preferably chosen so that the fracture surface is substantially parallel with the first end  26  of the female cylinder  21  to minimize the friction there between. The tilting surface  42  is preferably arranged so that it provides for a slope towards the unscrewing direction to reduce the friction formed between the female cylinder  21  and the body  60 . This is of course applicable to all embodiments herein. 
         [0044]      FIGS. 3   a - 3   b  show the supportive housing  30  in greater detail and separated from the other parts of the medical adaptor device  10  for the sake of clarity. The supportive housing  30  has a substantially cylindrical form having an upper and a lower end, equivalent to a first and a second end  31 ,  32  and an inner and an outer surface  33 ,  34 . A plurality of, in this embodiment four, wedge like protrusions  35  extend out from the inner surface  33  of the supportive housing  30  in the proximity of the first end  31 , although only two wedge like protrusions  35  are shown in  FIGS. 3   a - 3   b . The wedge like protrusions  35  have a tapering surface, tapering towards the first end  31  of the supportive housing  30 . At the second end  32  of the supportive housing  30  is a circumferential stop flange  36 , which extends around the inner surface  33  and protrudes towards the centre axis A. The purpose of the circumferential stop flange  36  and the wedge like protrusions  35  will be described in greater detail below. 
         [0045]      FIG. 4  shows a cross section of the medical adaptor device  10  shown in  FIG. 1 . More specifically,  FIG. 4  shows the second connection site  11  with the barrier member  16 , the first connection site  20  and a fluid channel  50  extending there between. A body  60  defines the fluid channel  50  and the male tapered connection part  28  as can be seen extending past the lower edge  27  of the female cylinder  21 . The supportive housing  30  encloses the female cylinder  21  of the first connection site  20 . During assembly, the supportive housing  30  is slid onto the female cylinder  21  until the wedge like protrusions  35  snap onto a lock flange  61 , which extends around the periphery of the body  60 . The wedge like protrusions  35  and the lock flange  61  of the body  60  prevent the supporting housing  30  from movement along the centre axis A. In addition, the second connection site  11  can be arranged to be positioned adjacent the upper end  31  of the supportive housing  30  to prevent the supportive housing from movement along the centre axis A, at least in one direction. As can further be seen in  FIG. 4 , the circumferential stop flange  36  of the supportive housing  30  is, after assembly, positioned substantially adjacent the corresponding stop flange  29  of the female cylinder  21 . Optionally part of the second end  27  of the female cylinder  21  can be used to cooperate with the circumferential stop flange  36 . 
         [0046]    The supportive housing  30  permits the female cylinder to rotate around the centre axis A, after the designated ruptureable retaining members  41  are ruptured. It further keeps the female cylinder  21  from motion in the longitudinal direction of the centre axis A. This enables the medical adaptor device  10  to be tamper resistant in the meaning of that any device which is attached with the medical adaptor device  10  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  11  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  41  whereafter the friction between the female cylinder  21  and the body  60  and the supportive housing  30  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  FIGS. 5   a - 5   b.    
         [0047]      FIGS. 5   a - 5   b  show the medical adaptor device  10  as shown in  FIG. 1  and  FIG. 4  after connection with a female catheter connection part  70 . The female catheter connection part  70  has been screwed onto the threads  25  of the female cylinder  21  until the male tapered connection part  28  of the body  60  engages the inner surface  71  of the female catheter connection part  70 . When continuing the rotational motion, i.e. the threading, the friction between the male tapered connection part  28  and the inner surface  71  of the female catheter connection part  70  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  41  rupture. As can be seen in  FIG. 5   a , the designated ruptureable retaining members  41  are formed integrally with the body  60  and the female cylinder  21  of the medical adaptor device  10 , for example by form molding with a termoplastic material. In other embodiments, according to the present invention, the at least one designated ruptureable retaining member(s)  41  can be made form different material(s), combinations of integrally formed designated ruptureable retaining members  41  and designated ruptureable retaining members  41  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  41  manufactured in a termoplastic material. 
         [0048]    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  41  are about to break by an indication on the connector, in this case the medical adaptor device  10 , corresponding to the required rotational distance before rupture, which can be calculated or evaluated. 
         [0049]      FIG. 5   b  shows the female catheter connection part  70  after being connected to the luer lock type connection of the medical adaptor device  10 . The female catheter connection part  70  can now be connected to a medical device having a double membrane bayonet coupling via the medical adaptor device  10 . As can further be seen, the designated ruptureable retaining members  41  have ruptured, thereby permitting the female cylinder  21  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  21  can be freely rotated, the second connection site  11  can also be freely rotated, with respect to the first connection site  20 , i.e. the luer lock connection and the female catheter connection part  70 . Hence, the medical adaptor device  10  in principle cannot be removed from the female catheter connection part  70 . 
         [0050]    It is further notable that the risk of leakage between the inner surface  71  of the female catheter connection part  70  and the male tapered connection part  28  is very low. In fact, the male tapered connection part  28  can be rotated inside of the female catheter connection part  70  without leakage. Should it be desirable for any reason to further improve the leakage preventive properties of the medical adaptor device  10 , the medical adaptor device  10  can be provided with at least one leakage barrier, preferably in the near proximity of the root of the male tapered connection part  28 , 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  70 . The connection arrangement  1 , in this case the medical adaptor device  10 , 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  28 . 
         [0051]    It is further notable that the supportive housing  30  can be arranged with means to prevent it from rotation with respect to the second connection site  11 . 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  10  by providing a larger grip area. 
       Injector 
       [0052]    The present invention will be further described with reference to a second embodiment according to the present invention. In this embodiment, the connection arrangement  1  is applied to a piercing member protection device  99  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 WO2008/115102 in the name of Carmel Pharma AB. 
         [0053]      FIG. 6  shows the piercing member protection device  99  with a longitudinal centre axis A extending in the longitudinal direction of the piercing member protection device  99  and in the centre of the piercing member protection device  99 . Generally the piercing member protection device  99  exhibits a first cylindrical member  100  which is at least partly encompassed by a second cylindrical member  200 , which in turn is at least partly encompassed by a third cylindrical member  300 . A piercing member (not shown) is connected to the third cylindrical member  300  and extends into a protection chamber defined by the interior of the first cylindrical member  100 . A first barrier member  101 , 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  100  to provide a closed environment for at least the tip of the piercing member of the piercing member protection device  99 . This position is also referred to as the unexposed state, as the piercing member is unexposed inside the protective chamber. 
         [0054]    A first locking arrangement  250  is provided between the first cylindrical member  100  and the second cylindrical member  200 . The first locking arrangement  250  can be arranged in a first position in which the first cylindrical member  100  is enabled to be turned with respect to the second cylindrical member  200  and a second position in which the first cylindrical member  100  is disabled form turning with respect to the second cylindrical member  200 . The second locking device can be alternated between the first and the second position by means of connecting the piercing member protection device  99  to the connection port. 
         [0055]    A second locking arrangement provides a first position in which the piercing member, and the third cylindrical member  300 , is enabled to move along the centre axis A with respect to the first barrier member  101 , and a second position in which the piercing member, and the third cylindrical member  300 , is prevented from moving along the longitudinal centre axis A with respect to the first barrier member  101 . The second locking arrangement  350  is alternated between the first position and the second position by means of turning the first cylindrical member  100  and the third cylindrical member  300  with respect to the second cylindrical member  200 . 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  101 , 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  300  and a corresponding protrusion on the second cylindrical member  200 . 
         [0056]    As can further be seen in  FIG. 6 , the third cylindrical member  300  comprises a first connection site  111  having a threaded female connection part  112  for connection with a male luer lock connection on e.g. a syringe. The first connection site  111  is connected to the third cylinder member  300  via at least one ruptureable retaining member  141 , in the shown embodiment of  FIG. 6 , five designated ruptureable retaining members  141 , although only four can be seen. This permits the first connection site  111  to freely rotate around the centre axis A, after the designated ruptureable retaining members  141  are ruptured. It further prevents the first connection site  111  from motion in the longitudinal direction of the centre axis A. This enables the piercing member protection device  99  to be tamper resistant in the meaning of that any device which is attached to the piercing member protection device  99  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  111  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  141  whereafter the friction between the first connection site  111  and the third cylinder member  300  is so low that a counter rotational motion does not unscrew the medical device, in this case a syringe. 
         [0057]    In the embodiment shown in  FIG. 6 , the designated ruptureable retaining members  141  are assembled to the piercing member protection device  99  via a ring body  160  having an inner and an outer ring member  161 ,  162 , as seen in greater detail in  FIG. 7 . By the terms inner and outer rings, is meant with reference to the centre axis A.  FIG. 7  shows further that the outer ring member  161  comprises a plurality of deformable lock flanges  163  which are arranged to, during assembly, deform so that the deformable lock flanges  163  can be positioned to engage and lock the ring body  160  to the third cylinder member  300  at a plurality of corresponding lock grooves  310  (shown in  FIG. 9 ). Each deformable lock flange  163  comprises a lock protrusion extending from the distal end of the deformable lock flanges  163  towards the centre axis A. 
         [0058]    The ring body  160  also exhibits a first and a second end  165 ,  166 , equivalent to the upper and the lower end  165 ,  166  as seen in  FIG. 7 . In the near proximity of the first end  165  of the ring body  160 , five designated ruptureable retaining members  141  attach the inner ring member  161  to the outer ring member  162  preventing the inner ring member  161  from substantially any motion with respect to the outer ring member  162  before the designated ruptureable retaining members  141  are ruptured by a predetermined shear force. Each of the designated ruptureable retaining members  141  exhibit a tilting surface  142  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  161 ,  162  after the designated ruptureable retaining members  141  have been ruptured. The designated ruptureable retaining members  141  are made integrally with the cylindrical body  160 . However, as mentioned earlier, they can be made from different materials or combinations thereof. 
         [0059]    The inner ring  161  comprises attachment flanges  170  to provide a snap on connection between the first connection site  111  and the inner ring  161 .  FIG. 8  shows the first connection site  111  in greater detail. As can be seen, the first connection site  111  comprises a threaded female connection part  112  equipped with threads  113  for a rotational connection with a medical device (not shown) such as a syringe. The threaded female connection part  112  comprises a distal end  114  and a proximal end  115 . The proximal end  115  of the threaded female connection part  112  is arranged on a cylindrical base  120  having a first and a second locking flange  121 ,  122  for providing a snap on connection with the inner ring  161  and the corresponding attachment flanges  170 . Furthermore, the cylindrical base  120  comprises a circumferential channel  125  extend around the periphery of the cylindrical base  120  permitting, after assembly, free rotation of the cylindrical base  120  with respect to the third cylinder  300  of the piercing member protection device  99 . 
         [0060]    As is noticed, the cylindrical base  120  and the inner ring member  161  of the ring body  160  forms the body while the outer ring  162  and optionally the third cylinder member  300  forms a first connection member. 
         [0061]      FIG. 9  shows the third cylinder member  300  in greater detail without any other components attached. As can be seen, the third cylinder member  300  comprises a plurality of lock grooves  310  for connection with the ring body  160  and the deformable lock flanges  163  of the outer ring  162  of the ring body  160 . Wedge like protrusions  311  are arranged on the inside of the third cylinder member  300  in the proximity of an upper end  301  of the third cylinder member  300 , and extending towards the centre axis A enabling a snap on connection with the circumferential channel  125  of the cylinder base  120 . 
         [0062]      FIG. 10  shows a cross section of the third cylinder member  300 , the ring body  160  and the first connection site  11  after assembly and before rupture of the designated ruptureable retaining members  141 . An infusion tube  400  is threaded onto the threaded female connection part  112  of the first connection site  111 . As the infusion tube  400  is connected by a rotational motion, the luer lock connection provides for a liquid tight seal between the first connection site  111  and the infusion tube  400 . As the rotational motion continues, the connection is tightened and a predetermined threshold of stress, in this case about 25 Ncm, the shear force imparted from the infusion tube  400  ruptures the designated ruptureable retaining members  141  of the cylindrical body  160 . As the designated ruptureable retaining members  141  of the cylindrical body  160  rupture, the inner ring  161  of the cylindrical body  160  is permitted to freely rotate around the centre axis A, disabling any attempts to disconnect the infusion tube  400 . 
       Infusion Bag 
       [0063]    In a third embodiment according to the present invention, the connection arrangement is utilized on an infusion bag connection system  500  for a tamper resistant connection to an infusion bag  501 . As is seen in  FIG. 11 , the infusion bag connection system  500  comprises a second connection site  503 , as described earlier with reference to  FIGS. 4 and 5   a - 5   b . That is, a body, a first connection member  505 , in the form of a female cylinder  521  having a threaded inner surface  522 , is fixedly connected to the body  504  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  521  can be freely rotated around the centre axis A with respect to the body  504 . A fluid transfer channel  550  is arranged in the body  504 . 
         [0064]    As has been shown, the connection arrangement  1  according to present invention can advantageously be used as a male luer lock connection. Additionally the connection arrangement  1  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. 
       Female Luer Lock Type Connection 
       [0065]    It is also within the boundaries of the present invention that the connection arrangement  1  is used as a female luer lock connection, as is shown in  FIG. 12   a - 12   b  exemplified with a disposable syringe (only a part of the syringe is shown for the sake of clarity and without its plunger).  FIG. 12   a  shows a cross section of a syringe  600  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. 12   b  shows the syringe as seen in perspective. The syringe  600  is preferably of the disposable type. 
         [0066]    With reference to both  FIGS. 12   a  and  12   b , the syringe  600  comprises a fluid housing  601  in which drugs can be temporarily contained before administration trough a dispensing opening  602 , arranged in the end of the fluid housing  601 . The fluid housing  601  further comprises a second opening (not shown) through which a plunger can be inserted for volumetric control of the fluid housing. The dispensing opening  602  comprises a dispensing channel housing  603  with a dispensing channel and with a slightly tapered inner surface  604 , 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  28  in  FIG. 2  or  FIG. 4 . The dispensing channel housing  603  exhibit a distal end  605 , and a proximal end  606  wherein the proximal end is arranged on the fluid housing  601  of the syringe  600 . 
         [0067]    A cylinder  620  having an outer and an inner surface  621 ,  622  and a first and a second end  623 ,  624  is arranged on the dispensing channel housing  603 . The outer surface  621  facing away from the centre axis A. Threads  625  are arranged on the outer surface  621  of the cylinder  620  for connection with a male luer lock connection. The distal end  605  of the dispensing channel housing  603  comprises a circumferential lock flange  607  to substantially prevent the cylinder  620  from motion in a direction along the centre axis A, at least in a direction away from the fluid housing  601 , the fluid housing  601  being a natural stop in the other direction. 
         [0068]    As is noted, the dispensing channel housing  603  form together with the fluid housing  601  a body while the cylinder  620  form a first connection member. A connection site  610  is formed by the dispensing channel housing  603  and the cylinder  620 . 
         [0069]    The cylinder  620  is attached to the circumferential lock flange  607  via a plurality of designated ruptureable retaining members  641 . The designated ruptureable retaining members  641  prevent the rotation of the cylinder  620  with respect to the fluid housing  601  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  641  is surpassed, fracturing the ruputureable retaining members  641 . As the designated ruptureable retaining members rupture, the cylinder  620  of the syringe  600  can rotate freely, with respect to the fluid housing  601  of the syringe, without risking that the syringe and the medical device is disconnected. 
         [0070]    The fluid housing  601 , the designated ruptureable retaining members  641 , the cylinder  620 , the circumferential lock flange  607  and the dispensing channel housing  603  can be formed integrally from the same material. Optionally, the designated ruptureable retaining members can be formed from another material; the cylinder  620  can be e.g. adhered to the dispensing channel housing  603  to form the designated ruptureable retaining members. 
         [0071]    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. 
         [0072]    Preferable material for manufacturing a connection arrangement according to the present invention as described above is polypropylene, polyethylene, PVC, polyurethane, acrylonitrile butadiene styrene (ABS), polystyrene, polyoxymethylene, polyethylene terephthalate, similar plastics or mixtures thereof, although other materials such as metal e.g. aluminum, steel, iron, brass, or alloys thereof are possible. Combinations of these materials are of course also possible.