Abstract:
The invention relates to a connector assembly ( 10 ) for the transfer of fluids, particularly fluids comprising an active agent from a reservoir to a medical device for dosage, comprising: a first connector element ( 20 ), pertaining to the reservoir with first fixing means ( 23 ), a second connector element ( 10 ), pertaining to the medical dosage device with second fixing means ( 12 ), cooperating with the first fixing means to give an irreversible connection between the two elements. The first and second elements are embodied such as to cooperate with other by clipping on a single translational movement of a connector element relative to the other to produce the irreversible connection, characterized in that at least one of the connection elements is embodied with means to render the same breakable.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a non-provisional application of International Application No. FR 2003/000736, filed Mar. 7, 2003. 
     FIELD OF THE INVENTION 
     The invention relates to a connection system for medical use adapted to transfer of fluids, particularly medicines, from a reservoir to a medical delivery device. 
     BACKGROUND OF THE INVENTION 
     Since risks of cross contaminations between different patients or between patients and care givers have been taken into consideration, it is now customary or even compulsory for the medical delivery device to be used once only for a specific patient, as certified by the development of “disposable” equipment sold as being sterile and discarded after use. Similarly, medicines are more and more frequently sold in vials containing a single dose, making it impossible to use it on several patients and limiting risks of dosage errors. However, despite the “disposable” indication signalled by medical delivery devices, there is nothing to prevent them from actually being reused on several patients. Thus for example, a needle for an intravenous injection can be connected to a syringe containing a dose of medicine and can therefore be used to deliver the said dose to several patients. Many solutions have been proposed firstly to the problem of reuse of these hypodermic needles and syringes, and secondly to accidental contamination by the injection, and invariably lead to single use of the syringe and/or the needle. 
     However, some medicines are in a form that needs to be prepared by dilution, for example a freeze-dried powder. Preparation of such a medicine consists of mixing the form to be diluted with a solvent in specific proportions and transferring the solution obtained into the medical delivery device. In general, the solvent is drawn up firstly with the syringe and is then injected into the receptacle containing the freeze-dried powder. After mixing, the mix is drawn up with the syringe again. The syringe is then connected to the medical delivery device so that the said mix can be administered. Consequently, the connection between the syringe and the various receptacles must be made and disassembled as often as necessary, in order to make the mix. The last connection made is the connection between the syringe and the medical delivery device. 
     U.S. Pat. No. 6,231,552 describes a connection assembly between a reservoir, in this case a syringe, and a medical delivery device, in this case a hypodermic needle. At the syringe, this connection assembly uses a standard male Luer cone surrounded by a coaxial cylinder at the cone with a thread on the internal face, and a notch is formed at the free end of the thread. The needle has a standard female Luer cone compatible with the male Luer cone on the syringe and a thread complementary to the thread on the syringe formed on the outer surface of the base of the hypodermic needle. Furthermore, a pin projects from the said external surface at the distal end of the needle thread. Thus, when the syringe is connected to the needle, after screwing to make the two threads mentioned above cooperate, the pin on the hypodermic needle clips irreversibly into the notch in the syringe provided for it. The resulting system prevents the reservoir and the medical delivery device from being disconnected, while enabling the standard male and female “lock” type Luer connectors to be reversibly connected (with a thread like that described above). The system becomes irreversible only when making the connection between Luer cones including either the projecting pin or the notch in which the pin will fit. 
     The disadvantage of this type of device is that the user must make a translation movement combined with a rotation movement (helical movement) to irreversibly connect such a system, and to make the connection while providing an additional force of the end of screwing to engage the said irreversible retaining means between the two elements, while the male and female Luer cones are already cooperating by contact so as to make the connection leak tight. 
     SUMMARY OF THE INVENTION 
     One purpose of the invention is to provide an irreversible connection assembly between a reservoir and a medical delivery device assembled during an extremely single connection movement. 
     To achieve this purpose according to the invention, a connection assembly is provided for transfer of fluid, particularly fluid containing active products, from a reservoir to a medical delivery device comprising a first connection element associated with the reservoir and comprising first retaining means, a second connection element associated with the medical delivery device and comprising second retaining means capable of cooperating with the first retaining means to form an irreversible connection between the two connection elements, the first and second retaining means being arranged such that they cooperate with each other by clipping during a simple translation movement of one connection element with respect to the other to make the connection irreversible. 
     Thus, this particular arrangement of retaining means enables the user connecting a medical delivery device to a reservoir, both being equipped with such connection elements, to irreversibly connect them to each other by making a single translation movement, as he would normally do with standard connection elements such as male and female Luer cones. 
     Advantageously, all connection elements have at least one of the following additional characteristics:
         either the first or second retaining means comprises at least one elastically deformable tab and the other retaining means comprises at least one lip capable of cooperating with the said tab,   either the first or second retaining means comprises two tabs located on opposite sides of the connection element,   either the first or second retaining means comprises at least one recess and the other retaining means comprises at least one lip capable of cooperating with the recess,   the lip is elastically deformable,   either the first or second connection element comprises a male part and the other connection element comprises a female part with a shape complementary to the male part and capable of cooperating with the male part so as to make the connection leak tight,   the male and female parts are Luer cones with a taper of about 6%,   the male part is an essentially tubular shaped perforator, and   at least one of the connection elements comprises means capable of making it breakable.       

     The invention also includes a connection element for the transfer of fluid, particularly a fluid containing active products, from a reservoir to a medical delivery device containing retaining means arranged so as to cooperate with the retaining means in another connection element by clipping during a translation movement between the two connection elements so as to make an irreversible connection between the two connection elements. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Other characteristics and advantages of the invention will become clearer after reading the following description of one embodiment and variants. In the attached drawings: 
         FIGS. 1   a ,  1   b  and  1   c  are sectional and three-dimensional views of a first embodiment of the invention in the disconnected position and then in the connected position, 
         FIGS. 2   a ,  2   b  and  2   c  are sectional and three-dimensional views of a variant of the embodiment in  FIG. 1 , 
         FIG. 3  is a three-dimensional view of a second variant embodiment of a connection element in  FIG. 1 , 
         FIG. 4  is a sectional view of a third variant embodiment of the connection assembly in  FIG. 1 , 
         FIG. 5  illustrates the first method of using the invention in  FIG. 1 , 
         FIG. 6  illustrates a second method of using the invention in  FIG. 1 , 
         FIG. 7  is a third method of using the invention in  FIG. 1 , 
         FIG. 8  illustrates a method of using the invention in  FIG. 2  for freeze-dried products, 
         FIG. 9  is a sectional view of a second embodiment of the invention, and 
         FIG. 10  illustrates a method of using the invention in  FIG. 9 . 
     
    
    
     DETAILED DESCRIPTION 
     In this document, “fluid” refers to various medicines or active products obtained by chemical synthesis or a natural extract compound, designed to care or treat an infection or a body injury, or to correct or modify an organic function, or to produce a diagnostic. For example, anti-inflammatory drugs, antibiotics, antiviral agents, fungicides, anticancer agents, antiangiogenic agents, antiglaucomatous agents, neuroprotectors, neuromodulators, anesthetics, products intended for genic therapy such as oligonucleotides, plasmids, and nutrients, vitamins, salts, minerals and hormone products. A fluid may also be a body fluid such as blood or one of its compounds, gastric juices, urine, etc. 
     For further information about the definition of a medicine, the European Directive 65/65/CEE, Jan. 26 1965 dealing with legal requirements related to medicines gives the following definition: 
     “The following definitions are applicable in application of this directive: 
     1. Pharmaceutical specialty: any medicine prepared in advance, marketed under a special name and within special packaging. 
     2. Medicine: Any substance or composition presented as having remedial or preventive properties with regard to human or animal diseases. 
     Any substance or composition that can be administered to man or animal in order to produce a medical diagnostic or to restore, correct or modify organic functions in man or animal is also considered as being a medicine. 
     3. Substance: Any material regardless of its origin, which may be:
         human such as human blood and products derived from human blood,   animal such as micro-organisms, whole animals, parts of organs, animal secretions, toxins, substances obtained by extraction, products derived from blood, etc.   vegetable such as micro-organisms, plants, parts of plants, vegetable secretions, substances obtained by extraction, etc.   chemical such as elements, natural chemical materials and chemical transformation and synthesis products.       

     4. Magistral formula: any medicine prepared in a pharmacy using a prescription intended for a specific patient. 
     5. Officinal formula: any medicine prepared in a pharmacy according to the indications in a pharmacopoeia and that will be issued directly to patients supplied through this pharmacy”. 
     This is completed by Directive 2309/93, Jul. 22 1993: 
     “Medicines derived from one of the following biotechnological processes:
         recombining deoxyribonucleic acid technology,   controlled expression of coding genes for proteins biologically active in prokaryotes and eukaryotes, including transformed mammal cells,   methods based on hybridomes and monoclonal antibodies.       

     Veterinary medicines, including medicines not derived from biotechnology, intended for use mainly as performance enhancers to promote growth or to increase the productivity of treated animals”. 
     The following definitions are applicable in the remainder of the document:
         Medical delivery device, a device designed to come into contact with a tissue of the human body (skin, mucous membrane, muscle, etc.), or to penetrate into one of the cavities of the human body (oral or nasal cavity, bladder, genitals, eye, lung, etc.) or to penetrate into a circulation system (vein, artery) so as to enable systemic or local administration of a therapeutic active product or to sample a body fluid, in other words a fluid like that defined above. Examples include the following devices considered as being a medical delivery device: transdermic patch, intramuscular vaccination system, transdermic vaccination system, intravenous catheter, urethral probe, gastric probe, hypodermic needle, system for delivery of medicines by iontophoresis, by electroporation or other energy source, bronchial sampling catheter, etc.   Medicine or fluid reservoir. A reservoir containing the medicine ready to be administered. It may be a flexible or rigid single dose vial, a vial containing a treatment designed to be administered over several days either continuously (for example a flexible perfusion pack), or discontinuously (for example antibiotic treatment), a syringe containing the medicine dose after preparation, an aerosol vial, etc. This medicines reservoir is always provided with an end piece enabling a connection with the medical device, for example such as a standard Luer cone for a syringe or a perforatable rubber stopper for a rigid glass vial,   Luer, a standard male or female connection element composed of a cone with a taper of about 6%, and an inlet diameter of about 4 mm (for the male) and about 4.30 mm (for the female), used for medical purposes, defined by ISO international standards and used on all perfusion and transfusion lines (intravenous catheter, syringe and hypodermic needle, etc.),   Spike, a hollow metal or plastic needle used to perforate rubber stoppers (septa) for medicine containers (vials) to access the contents. There is no particular standard for these spikes, only on vials.       

     We will describe a first embodiment of the invention with reference to  FIGS. 1   a  to  1   c . The connection assembly  1  comprises two connection elements  10 ,  20  capable of cooperating with each other so as to make a connection that is firstly irreversible and secondly leak tight. 
     The connection element  10 , also called the female connector, is generally in an elongated shape of revolution. An internal duct  17  passes through it, from one side to the other and coaxial with the axis of revolution (not shown). The female connector  10  comprises three functional parts. The first part  14  is preferably an interface area with the medical delivery device. This part enables an attachment of the female connector onto the medical delivery device (not shown). For example, in the case illustrated in  FIG. 1 , this area is essentially tubular shaped and is capable of receiving a needle or a tube that is preferably assembled by gluing or insert moulding. This entire interface area  14  may be a part of the medical delivery device. In this case, the female connector  10  forms part of the medical delivery device and is integrated into it. 
     The second functional part of the female connector is a leak tight area  13  with a generally tubular external shape and with an internal face  15  in this case with a contact approximately equivalent to a female Luer cone as defined above and delimiting a part of the internal duct  17 . 
     The third part of the female connector is an area  11  designed to cooperate with the other connection element to make an irreversible connection. 
     The area  11  of the female connector  10  comprises a ring and a series of tabs  12  derived from the material used for the ring. These tabs have a free end  16  extending into the internal duct  17  and along the direction in which the male connector  20  is inserted into the female connector  10  illustrated by the arrow F. These tabs  12  are elastically deformable. 
     The connection element  20 , or the male connector, is generally in an elongated shape of revolution. An internal duct  25  passes through it, from one side to the other and coaxial with the axis of revolution (not shown). Similarly, the male connector  20  comprises three functional parts as follows. The part  21  is an interface area with the reservoir containing the medicine. In the same manner as above, this interface area  21  preferably forms part of the medicines reservoir. In this case, it is in the form of any essentially tubular area. Preferably, this entire interface area  21  may be a part of a medicines reservoir. Thus, the male connector  20  forms a part of the reservoir and consequently is integrated into it. For example, as we will be seen later, a single dose flexible medicine vial could be fitted with such a male connector. 
     A second part  23  is designed to cooperate with the area  11  of the female connector so as to make the connection irreversible. The part  23  comprises a lip  23  projecting from the external surface of the male connector. The lip  23  is preferably continuous around the entire circumference of the male connector  20 , as illustrated in  FIG. 1   b . The lip  23  has a first face  26  inclined at an angle preferably between approximately 10° and 45° with the axis of revolution of the male connector, then a second face  27  approximately perpendicular to the axis of revolution. The intersection of the faces  26 ,  27  forms a vertex of the lip  23 . The face  26  is along the direction of introduction illustrated by arrow F, and face  27  is on the opposite side. 
     Finally, the third part forming the male connector is a leak tight area  22  with an external surface  24  approximately equivalent to a male Luer cone as described above. 
     The female connector  10  is assembled with the male connector  20  using a single translation movement along the direction of the arrow F. When the male connector is inserted into the female connector, the lip  23  will deform the tabs  12  elastically, the face  26  pushing their end  16  back, and then once the vertex of the lip  23  has passed, the ends  16  in the tabs  12  return to their initial position then preventing disconnection of the two connection elements. If an attempt is made to perform a reverse translation movement along the direction of the arrow F, the ends  16  of the tabs  12  stop in contact with the lip  23 , particularly in contact with face  27 , thus preventing the movement. Once the male connector  20  has been inserted into the female connector  10 , the leak tight area  22  cooperates with the leak tight area  13  through a contact between the female Luer cone  15  and the male Luer cone  24 , thus making the said connection leak tight due to their complementary shape. Thus, the fluid passing through the internal duct  25  of the male connector can then circulate in the internal duct  17  in the female connector towards the medical delivery device without any loss of fluid towards the outside at the connection assembly. The assembly made is illustrated in  FIG. 1   c.    
     Note that the part  22  forming the leak tight area of the male connector  20  is approximately equivalent to a female Luer cone that connects the medicines reservoir to any other device comprising a standard Luer type female connector. This makes it possible to make solutions from freeze dried products and solvents that require a connection with the device containing the solvent and then a connection with the device containing the freeze dried product so as to make the solution before connecting to the medical delivery device. 
     We will now describe a variant of the previous embodiment, with reference to  FIGS. 2   a  to  2   c . The connection assembly  100  comprises a connection element  10  or female connector and a connection element  120  or male connector. In the same way as above, each of the connectors is in an elongated shape of revolution. It comprises an internal duct  117 ,  125  coaxial with the axis of revolution (not shown). It has three functional parts. The female connector  110  has a functional part  114  that will make the interface with the medicine device presented here in the form of a conical beam forming an end piece that will be force fitted into a flexible tube connected to the medical delivery device. Preferably, as in the previous case, the entire interface area  114  forms part of the medical delivery device and thus the medical connector  110  forms an integral part of the medical delivery device. The female connector  110  has a second part  113  that forms the leak tight area with an essentially tubular internal contact face  115  and that is capable of cooperating with the complementary shape of the male connector  120  as we will describe below. Finally, the female connector  110  has a third part  111  very similar to the part  11  of the previous embodiment comprising a ring  111  and two tabs  112  opposite each other on each side of the internal duct  117 . As described above, the tabs are made from the same material as the ring of the connector  110 , and have a free end  116  facing the direction of insertion illustrated by the arrow F, and also facing the inside of the duct  117 . 
     The male connector  120  is provided with an internal duct  125  used to transfer fluid from a medicines reservoir not shown, to an opposite end  126 . This male connector  120  has three functional parts. The part  121  is designed to make the interface with a medicines reservoir. This interface is made in exactly the same way as in the previous embodiment. It is possible that this interface comprises a female Luer type cone  127  designed to cooperate with a standard syringe with a complementary male Luer cone forming the reservoir. The male connector  120  then has a part forming a leak tight area  122  comprising an essentially tubular external surface  124  capable of cooperating with the surface  115  of the female connector  110  so as to make the connection leak tight. Finally, the male connector  120  has an area  123  that cooperates with the lip  123  projecting outwards, designed to cooperate with the tabs  112  of the female connector  110  to make the connection irreversible. The assembly illustrated in  FIG. 2   c  is manufactured and assembled in the same way as the assembly in the previous embodiment illustrated in  FIG. 1   c  and described above. 
     Note that in  FIGS. 2   a  to  2   c , the area  122  of the male connector  120  is advantageously in the form of a spike capable of perforating rubber stoppers of medicine vials. For example, it would be possible to imagine that this type of connector could be installed or could form an integral part of a syringe for sampling sterile water, or any other solvent for injection, contained in a vial with a stopper. This sterile water could then be transferred into a second vial with a stopper containing freeze dried active products in order to dilute the freeze dried active products and obtain a solution, and then making an irreversible permanent connection with a medical delivery device comprising a female connector  110  described above. 
     The minimum number of tabs  12  or  112  is 1. However, it is very advantageous to have an even number of tabs uniformly distributed around the ring of the female connector. One variant embodiment is illustrated in  FIG. 3  in which the female connector  210  is different from the female connector  110  in that it comprises 8 tabs  212  uniformly distributed around the ring of the connector  210 . Industrially, the use of two tabs as illustrated in  FIGS. 1   a  to  2   c  is preferable, since it facilitates the manufacture of the female connector by plastic injection. 
     A second variant embodiment of a female connector is illustrated in  FIG. 4 , and consists of making a continuous recess in the form of a ring  312 . In this case, the connection assembly  300  comprises a male connector  10  like that described above and a female connector  310  associated with a needle  314  and with a structure identical to the connector  10  described above. This connector  310  is also differentiated from the connector  10  by the fact that the area  311  does not have any tabs, but instead it has a recess in the form of a ring  312  in which the lip  23  of the male connector  20  will fit during assembly. This type of embodiment requires that the material from which the connector  310  is made should be an elastic material allowing deformation of a cone  316  located between the recess and the connector entry, through the lip  23  so as to allow the lip  23  to pass through until it reaches the recess  312 . 
     We will now describe a variant embodiment of the male connector  120 , with reference to  FIGS. 9 and 10 . The male connector  420  is identical to the male connector  120  except that it is provided with a continuous notch  426  around its entire outer periphery between the lip  123  and the part  121  forming the interface area with the medicines reservoir. This notch  426  weakens the male connector  420  at this location, such that the connector will break at this location if a small shear force is applied. This so-called breakable area means that once the fluid has been transferred between the medicines reservoir and the medical delivery device, the said reservoir can be broken off from the said device leaving a part of the male connector in the female connector. This means that the medicines reservoir part can be separated from the delivery medical device once the medicine has been transferred, to avoid uselessly increasing the size of the said medical delivery device during use. Moreover, the fact that part of the male connector is left in the female connector makes it even more difficult to use the female connector, and therefore the medical delivery device, afterwards. This situation is illustrated in  FIG. 10  in which a female connector  110  is connected to a medical delivery device  64  through a non-return valve  65 , or an non-reflux valve, that prevents fluid from coming out after injection and rupture of the male connector. In this case, the male connector  420  is shown broken off at the notch  426  and forms an integral part of a syringe forming a medicines reservoir  54 . 
     Note that preferably, in general, the male connector described forming the connection assembly is fully integrated into the medicines reservoir, and the complementary female connector is fully integrated into the medical delivery device. 
       FIG. 5  illustrates a first method of using a connection assembly illustrated in  FIGS. 1   a  to  1   c , in this case the female connector  10  is installed fixed to a hypodermic needle  60  that could also be a catheter or a probe. The male connector is also installed in a fixed manner on a single dose or multi-dose syringe containing the medicine. It is important to note that in this type of configuration, the syringe may be connected reversibly with a standard female Luer. For example, it is consequently possible to sample a medicine or a body fluid from a source equipped with a standard female Luer connector, to disconnect from it after the medicine or the fluid has been sampled, and then to inject this fluid into the needle or the catheter mentioned above without necessarily disconnecting the medical delivery device  60  again. 
       FIG. 6  illustrates a second method of using the connection assembly shown in  FIGS. 1   a  to  1   c , in which the medical delivery device is a perfusion pack prefilled with a solute (for example glucosed water) and having a female connector  10  integrated into it to mix the solute of the pack  61  with a single medicine dose, for example such as an antibiotic. A single-dose vial  51  forming a medicines reservoir and integrating a male connector  20  may be installed irreversibly into the female connector  10 . The fact that this type of connector is placed on the access path to the perfusion pack then makes it impossible to reuse this access, and is a simple means of preventing any risk of accidental overdose of the medicine to be injected. 
       FIG. 7  illustrates a third method of using the connection assembly in  FIG. 1   a  to  1   c . In this example, the medical delivery device is a device for transfer of intraocular or transdermic or transmucous medicine, in which the female connector  10  forms an integral part of the device. An intraocular medicine transfer device is described in more detail in French patent application FR 2 773 320. Consequently, a flexible single-dose vial  52  is equipped with a connector  20 . With this single-dose vial, the assembly is unusable a second time after it has been connected to the medical delivery device and after the medicine has been transferred from the vial to the medical delivery device. 
       FIG. 8  illustrates a method of using the invention as illustrated in  FIGS. 2   a  to  2   c.    
     This figure illustrates a procedure to be followed for preparation of a medicine in freeze-dried form. The male connector in the form of a spike  120  is installed fixed onto the syringe or any other medicines reservoir provided with a suction device. In the first step A, the necessary quantity of solution is drawn up by perforating the septum of the vial  70  containing it. In step B, the previously drawn in solution is injected into a vial  71  containing a freeze-dried product by perforating the septum of the vial  71  in the same manner. The solution is then drawn back into this vial. In step C, the syringe  53  is irreversibly connected into a female connector  110  connected to the medical delivery device  63  illustrated in the figure simply by a supply cable. 
     The materials used to make this type of connector are preferably polymer materials frequently used for manufacturing connectors for devices for medical purposes, naturally having elastic properties enabling clipping by deformation of connector tabs while providing good mechanical strength and being suitable for injection moulding or moulding in a shaped mould. For example, materials in the polystyrene, polycarbonate, polyvinyl chloride, polyethylene, polypropylene, polyurethane, polyamide, polysulfone families, etc. can be used, without this list being exhaustive. Moreover, some metallic alloys may be suitable for this application, the aptitude for reversible elastic deformation being a criterion for the choice of such alloys. 
     Note also that the female connector in the preferred embodiments illustrated in the figures cannot be used with standard male Luer connectors. 
     Obviously, many modifications could be made to the invention without departing from its scope. 
     For example, the male connector may have deformable tabs with a deformable free end on the outside facing the direction of insertion, instead of a lip  23 . The female connector may have a lip instead of the tabs  12 , projecting towards the inside of the duct  17  and capable of cooperating with the tabs on the male connector to make the connection irreversible, and during insertion the lip deforms the tabs that return to their initial positions after insertion. Any reverse movement to disconnect the assembly is made impossible due to the fact that the said tabs stop in contact with the lip.