CONNECTOR FOR MEDICAL, DIAGNOSTIC AND PHYSIOLOGICAL FLUIDS CONTAINERS

Description

Patent Description for Industrial Invention entitled: “CONNECTOR FOR MEDICAL FLUID CONTAINERS, DIAGNOSTIC AND PHYSIOLOGICAL”. On behalf of: SIDAM Srl, a company incorporated and existing under the law Italian, with headquarters in 41037 MIRANDOLA (MO). Designated inventors: AZZOLINI Graziano, UGLIANO Giuseppe. DESCRIPTION The present invention relates to a connector for fluid containers. medical, diagnostic and physiological. With particular reference to the medical field, the need for connect infusion lines together to allow for transfer and / or the mixing of fluids contained therein. These infusion lines can be of different types; in the field In this document, the term “infusion lines” refers to any device that allows the transfer of drugs, means of contrast, blood or any other physiological / medical fluid and which, for example for example, it consists of flexible bags, bottles, syringes, tubes, etc. Infusion lines usually include a coupling portion matable to a connector. The known type of connectors are essentially valves which, once open, they allow the fluid-dynamic connection between the infusion lines connected to the connectors themselves. In detail, the known type connectors comprise a hollow body featuring an upper entrance, which can be coupled to a first line of infusion, and a lower inlet, which can be coupled to a second line of infusion. The aforementioned entrances are usually positioned at two ends opposite sides of the hollow body and are such that both couplings with the infusion lines are removable. With particular reference to the administration of contrast media, the upper inlet is coupled to a first infusion line multi-patient and the lower entrance is coupled to a second line of infusion connected to a patient. In detail, internally the hollow body forms a pointed element covered by a sealing element made of flexible material, usually of an elastic nature, and designed to occlude the upper entrance, when not associated with the first infusion line; in this configuration the connector is closed and does not allow the passage of fluids. When the hollow body is coupled to the first infusion line, the sealing element is pressed by a hook portion present in the first infusion line and flows along the outer wall of the element pointed. In this way the sharp element is exposed and enters inside of the hook portion, thus allowing the connection fluid dynamics between the first infusion line connected to the opening upper and the second infusion line connected to the lower opening. Patent documents WO2015044834A1 and WO2015044835A1 show a particular type of connector made of only two pieces: the body cable and the sealing element. The hollow body is obtained by plastic moulding and has, at least initially, the upper opening widened, to allow the insertion of the sealing element during connector assembly. Once the sealing element is inserted, the hollow body is deformed, to for example by heating it which allows it to soften plastic, so as to obtain a folded portion that narrows the opening upper and prevents the sealing element from coming out of the body cable. The known type connectors have some drawbacks. In this regard, it is emphasized how fundamentally important it is the fact that the passage of fluids between the interconnected infusion lines through a connector takes place within a closed circuit. In particular, it is necessary that the infusion lines and the connector are in fluid dynamic communication between them but they must be completely isolated from the external environment; it is extremely essential that this condition persists throughout the communication phase fluid dynamics between the infusion lines themselves. The coupling between the upper opening and the first infusion line is made by simply inserting the hook portion into the upper opening itself. Sometimes the coupling portion of the first infusion line and the opening upper part of the hollow body includes locking means, for example Luer-lock type, equipped with threads that facilitate their mutual and stable connection union. Sometimes, however, the hook portion consists exclusively of a tubular section without threads and Luer-lock coupling systems; it is the case, for example, of traditional syringes which have one end for the inlet and outlet of fluids consisting exclusively of a tube truncated cone. It is easy to understand how the association between a traditional syringe free of luer-lock and the known type connector is rather weak and easily removable while using the connector itself. In these cases the first infusion line often loses adhesion with the upper opening and this determines the total or partial exit of the attachment portion of the first infusion line from the upper opening, resulting in the leakage of fluids, which may undergo a bacterial contamination due to contact with the external environment, thus becoming dangerous for the health of patients and therefore unusable. This circumstance assumes particular relevance with reference to the administration of contrast media which are administered to pressures of approximately 25 bar and have high viscosity. In detail, it is essential to ensure the mechanical and hydraulic seal of the device in such a way as to avoid load losses and release accidental disconnection of the first infusion line from the second, resulting in the fluid leakage. Again, fluids leaking from the circuit can directly contact the healthcare workers employed to handle the connector, exposing them to biological risk or chemical risk. In this regard, consider the case in which the fluids handled are, for example, blood or other body fluids; direct contact with them by a operator may expose him to the risk of contracting serious pathologies. Again, consider the case where one of the infusion lines contains a example chemotherapy drugs or contrast media which are notoriously toxic and, therefore, can cause serious side effects people in case of direct exposure. Again, in case one of the infusion lines is connected directly to a patient's circulatory system, the loss of adhesion between the upper opening and the attachment portion of the first line of infusion can cause the patient's blood to flow back, which can be very dangerous for the health of the patient involved. All the above mentioned drawbacks are particularly felt for connectors shown in patent documents No. WO2015044834A1 and No. WO2015044835A1. In these connectors the upper opening, which, as mentioned, is obtained by deformation and shrinkage of a bent portion, not can have an exact shape and calibrated dimensions that allow for snap-fit ​​the coupling portion of a traditional syringe. The main task of the present invention is to devise a connector for containers of medical, diagnostic and physiological fluids that allows to guarantee the mechanical and hydraulic seal of the device, limiting the involuntary release of the hook portion of the first infusion line with respect to the upper opening of the connector itself. Another purpose of the present invention is to devise a connector for containers for medical, diagnostic and physiological fluids that allow for limit the cases of fluid leakage from the connector itself and from the lines infusion, reducing the risk of bacterial contamination of the fluids themselves and while limiting the negative health effects of the patients involved. Again, another purpose of the present invention is to devise a connector for containers of medical, diagnostic and physiological fluids that allows to reduce the level of exposure to biological and chemical risks for healthcare workers handling the connector connected to lines of infusion. Another object of the present invention is to devise a connector for containers of medical, diagnostic and physiological fluids which, in the event that the infusion lines are connected directly to the circulatory system of a patient, allows to reduce the phenomena of blood reflux. Another purpose of the present invention is to devise a connector for containers for medical, diagnostic and physiological fluids, which allow for overcome the aforementioned drawbacks of the prior art within the scope of a simple, rational, easy and effective to use and cost-effective solution content. The above mentioned purposes are achieved by the present connector for containers for medical, diagnostic and physiological fluids having the features of claim 1. Other features and advantages of the present invention will be found more evident from the description of a form of execution preferred, but not exclusive, connector for fluid containers medical, diagnostic and physiological, illustrated for illustrative purposes only, but not limiting, in the attached tables of drawings in which: Figure 1 is an exploded view of the connector according to the invention; Figure 2 is a view of the connector in the insertion position according to the found; Figure 3 is a view of the connector in the closed position according to the found; Figures 4 and 5 are cross-sectional views of the connector according to the invention during use. With particular reference to these figures, a globally indicated 1 has been indicated connector 1 for containers 2 of medical, diagnostic and physiological fluids. It is important to specify that in the context of this discussion, with the expression "medical, diagnostic and physiological fluids" does not mean not only liquid products but also viscous products, for example in the state of paste and gel, and of powdered products, especially very fine powders equipped with great smoothness. In the particular embodiment shown in the figures, the container 6 is of the type of an infusion bag which is of a type known to those skilled in the art. Connector 1 includes: - a first portion 3 comprising at least one tubular element 4 substantially hollow, having a substantially elongated shape along a central axis 5 and provided with at least one entrance opening 6 matable to at least one coupling portion 7 of a first line of infusion 8; - a second portion 9 associated with the first portion 3 by opposite to the entrance opening 6 and comprising at least one male element 10 which is arranged inside the tubular element 4, has a substantially elongated shape along the central axis 5 and is substantially hollow and provided with at least one first opening 12 for the fluid connection with a second infusion line 13 and a second opening 14, opposite to the first opening 12, for the fluid connection with the inlet opening 6; - interlocking connecting means 15 suitable for joining the first portion 3 and the second portion 9, where the first portion 3 and the second portion 9 they are connected to each other to allow the fluid passage between the first infusion line 8 and the second infusion line 13 of at least one fluid to be administered 16 to a patient. According to the invention, the tubular element 4 comprises a chamber containment 17 configured to house a sock sealing element 18 which consists of a single body made of elastic material deformable and fitted tightly around the male element 10, wherein the sock-shaped sealing element 18 is movable, due to the effect of the pressure exerted by the fluid to be administered 16 in the transition from the first portion 3 to the second portion 9, between a closing position, in which covers and seals the second opening 14, and an opening position, in which the second opening 14 is clear to allow communication fluid dynamics between the first infusion line 8 and the second infusion line infusion 13 . It is important to point out that the first infusion line 8 corresponds to the so-called multi-patient line and the second infusion line 13 corresponds to the so-called single-patient line. Advantageously, the sock-like sealing element 18 comprises at least one head portion 19 suitable for fitting close to the male element 10 at the second opening 14. As visible in the figures, the containment chamber 17 comprises a bottom portion 30 on which the head portion 19 rests of the sock sealing element 18. Conveniently, the aforementioned head portion 19 abuts on the element male 10. Preferably, the elastically deformable material is a material thermoplastic. In accordance with a preferred embodiment, such material is silicone. The head portion 19 comprises at least one notch 20 designed to allow the passage of the fluid to be administered 16. Advantageously, the head portion 19 comprises at least three notches 20 arranged equidistant from each other. In detail, the 20 notches are arranged radially. This means that the three notches 20 define three corresponding flaps 21 which, during the use of connector 1, due to the pressure exerted by the fluid to be administered 16 on each of the aforementioned flaps 21 (figure 4) determines the mutual distancing thus allowing the passage of the fluid to be administered itself. In other words, the flaps 21 are mobile, due to the pressure exerted from the fluid to be administered 16 on the same between a tightening position in which are brought close together and coplanar to each other and an open position in which they are mutually distanced to allow the passage of the fluid from administer 16. The presence of the flaps 21 allows to avoid the leakage of the fluid from administer 16 while releasing the first portion 3 from the second portion 9. In other words, the presence of the three flaps 21 allows to disconnect in safety the first portion 3 from the second portion 9, avoiding loss of fluid drops to be administered. The joining means 15 comprise at least one locking flap 22 made on the first portion 3 and suitable for matching the second portion 9 locking it by interlocking. In detail, the connecting means 15 comprise two locking fins 22 obtained on portions diametrically opposed to the central axis 5 of the first portion 3. However, alternative implementation solutions are not excluded in which the connector 1 includes three, four, five, etc. locking lugs 22. Each of the locking fins 22 comprises at least one locking tooth block 23. More specifically, the second portion 9 comprises at least one portion of invitation 24 provided with a side wall 25 inclined with respect to the axis central 5 and designed to facilitate the sliding of each of the fins block 22. It is useful to point out that in the context of this discussion the terms “lateral”, “laterally” and similar are to be understood in reference to a operating configuration in which the male element 10 is inserted inside of the tubular element 4 along the parallel insertion direction D to the central axis 5. The portion of invitation 24 has a substantially similar shape hollow truncated cone with a bottom wall 26 and a side wall 25. This conformation allows each of the fins to slide locking 22 along the side wall 25. Preferably, the invitation portion 24 comprises at least one edge of counter 27 suitable for countering each of the locking teeth 23. As visible in the figures, the abutment edge 27 is made of correspondence of the back wall 26. In detail, the locking fins 22 are movable, due to a external force applied on them, including: - an insertion position in which they are arranged reciprocally move away to allow the first portion to be released 3 from the second portion 9 (figure 2); and - a locking position in which the locking fins 22 engage the second portion 9 and the locking teeth 23 meet the contact edge 27 so as to allow the first one to be joined portion 3 and the second portion 9 (figure 3). In other words, an operator simply grasping the ends 28 of the locking flaps 22 and sliding the respective locking teeth 23 on the side wall 25 allows them to be moved away from each other, until reaching the reference edge 27 and the first hooking portion 3 to second portion 9. In essence, the first portion 3 is brought closer to the second portion 9 and, when inserting the male element 10 into the element tubular 4, the locking fins 22 slide on the side wall 25 in so as to allow the positioning of the locking teeth 23 on the edge of feedback 27. The synergistic combination of the truncated cone shape of the wall lateral 25 with the presence of the locking fins 22 allows for ensure mechanical tightness, ensuring its locking even in the face of high pressures. On the contrary, the unlocking of the first portion 3 from the second portion 9 occurs through the operator grasping the ends 28 of the locking flaps and by applying pressure on the latter, so as to allow their mutual distancing and the separation of the first portion 3 from the second portion 9. In this way, during the removal of the first portion 3 from the second portion 9, the flaps 21 return to being coplanar with each other in so as to close the second opening 14 and prevent it from leaking accidental administration of the fluid 16. In this regard, it is important to point out that the male element 10 is develops longitudinally in a coaxial manner within the portion of invitation 24 and is protruding at least in part with respect to the latter in a way such that, in the locked position, the bottom wall 26 meets in beaten tubular element 4. In this way, the seal between the male element 10 and the wall is guaranteed. bottom 26, so that the respective surfaces are in contact. In addition, the connector 1 comprises an auxiliary sealing element 29 interposed between the first portion 3 and the second portion 9. For this purpose, the auxiliary sealing element 29, in the position of locking, is housed within a defined space between the wall lateral 25 and the tubular element 4. Preferably, the auxiliary sealing element 29 has a annular conformation. Advantageously, the synergistic combination of the sealing element sock 18 with the auxiliary sealing element 29 allows to ensure the hydraulic and mechanical seal. With particular reference to the medical sector of the infusion of liquids contrast, this hydraulic seal is guaranteed at a pressure of approximately 25 Bar, preferably at a maximum flow rate of 10 ml / sec of a fluid such as high viscosity contrast fluid. Furthermore, this hydraulic seal is necessary in order to ensure the tightness of the device because when the single-patient line is disconnected it is necessary prevent fluid from dripping from the multi-patient area. In practice, it has been found that the described invention achieves the objectives proposed. It is emphasized that the particular provision of providing for the presence of a sock-like sealing element in combination with the element auxiliary sealing and locking fins allows to ensure the seal both hydraulic and mechanical of the device even when faced with pressures high pressures of approximately 25 Bar, and a maximum flow rate of 10 ml / sec of a fluid such as high viscosity contrast fluid.

Claims

CLAIMS 1) Connector (1) for containers of medical, diagnostic and physiological fluids, comprising: - at least a first portion (3) comprising at least one tubular element (4) substantially hollow, having a substantially elongated shape along a central axis (5) and comprising at least one inlet opening (6) which can be coupled to at least one coupling portion (7) of a first infusion line (8);- at least one second portion (9) associated with said first portion (3) on the opposite side to said inlet opening (6) and comprising at least one male element (10) which is arranged inside said tubular element (4), has a substantially elongated shape along said central axis (5) and is substantially hollow and provided with at least one first opening (12) for the fluid connection with a second infusion line (13) and with at least one second opening (14), opposite to said first opening (12), for the fluid connection with said inlet opening (6); - interlocking connecting means (15) suitable for associating said first portion (3) and said second portion (9), said first portion (3) and said second portion (9) being connected together to allow the fluid passage between said first infusion line (8) and said second infusion line (13) of at least one fluid to be administered (16) to a patient;characterised in that said tubular element (4) comprises at least one containment chamber (17) configured to house at least one sock-type sealing element (18) which consists of a single body made of elastically deformable material and fitted tightly around said male element (10), said sock-type sealing element (18) being movable, as a result of the pressure exerted by said fluid to be administered in the passage from said first portion (3) to said second portion (9), between a closed position, in which it covers and seals said second opening (14), and an open position, in which said second opening (14) is clear to allow fluid-dynamic communication between said first infusion line (8) and said second infusion line (13).; 2) Connector (1) according to claim 1, characterised in that said sock-shaped sealing element (18) comprises at least one head portion (19) suitable for fitting in proximity to said male element (10) in correspondence with said second opening (14). 3) Connector (1) according to one or more of the preceding claims, characterised in that said head portion (19) comprises at least one notch (20) suitable for allowing the passage of said fluid to be administered (16). 4) Connector (1) according to one or more of the preceding claims, characterised in that said head portion (19) comprises at least three notches (20) arranged equally spaced from each other. 5) Connector (1) according to one or more of the preceding claims, characterised in that said notches (20) are arranged radially. 6) Connector (1) according to one or more of the preceding claims, characterised in that it comprises at least one auxiliary sealing element (29) interposed between said first portion (3) and said second portion (9). 7) Connector (1) according to one or more of the preceding claims, characterised in that said connecting means (15) comprise at least one locking flap (22) made on said first portion (3) and suitable for meeting said second portion (9) by locking it by interlocking. 8) Connector (1) according to one or more of the preceding claims, characterised in that said connecting means (15) comprise two locking fins (22) obtained on portions diametrically opposed to the central axis (5) of the first portion (3). 9) Connector (1) according to one or more of the preceding claims, characterised in that each of said locking fins (22) comprises at least one locking tooth (23). 10) Connector (1) according to one or more of the preceding claims, characterised in that said guide portion 24) comprises at least one contact edge (27) suitable for contacting each of said locking teeth (23). 11) Connector (1) according to one or more of the preceding claims, characterised in that said locking tabs (22) are movable, as a result of an external force applied to them, between: - an insertion position in which they are arranged mutually distant from each other so as to allow the release of said first portion (3) from said second portion (9); and - a locking position in which said locking tabs (22) abut said second portion (9) and said locking teeth 23) abut said abutment edge (27) so as to allow the union of said first portion (3) and said second portion (9). 12) Connector (1) according to one or more of the preceding claims, characterised in that said second portion (9) comprises at least one invitation portion (24) provided with a lateral wall (25) inclined with respect to the central axis (5) and suitable for facilitating the sliding of each of said locking fins (22). 13) Connector (1) according to one or more of the preceding claims, characterised in that said invitation portion (24) has a substantially hollow truncated cone shape provided with a bottom wall (26) and said side wall (25). 14) Connector (1) according to one or more of the preceding claims, characterised in that said male element (10) develops longitudinally in a coaxial manner inside said invitation portion (24) and protrudes at least partially with respect to the latter in such a way that, in said locking position, said bottom wall (26) abuts said tubular element (4). 15) Connector (1) according to one or more of the preceding claims, characterised in that said auxiliary sealing element (29), in said locking position, is housed within a space defined between said side wall (25) and said tubular element (4).