Connector for medical, diagnostic and physiological fluid containers

Abstract

The connector (1) for medical, diagnostic and physiological fluid containers, comprises: - at least a first portion (3) comprising at least one substantially hollow tubular element (4), having a substantially elongated conformation along a central axis (5) and comprising at least one inlet opening (6) couplable to at least one hooking portion (7) of a first line of infusion (8); - at least a second portion (9) associated with the first portion (3) from the opposite side of the inlet opening (6) and comprising at least one male element (10) which is arranged within the tubular element (4), has a substantially elongated conformation along the central axis (5) and is substantially hollow and provided with at least a first opening (12) for the fluidic connection to a second line of infusion (13) and with at least a second opening (14), opposite the first opening (12), for the fluidic connection to the inlet opening (6); - joining means (15) by interlocking adapted to associate the first portion (3) with the second portion (9), the first portion (3) and the second portion (9) being linked together to allow the fluidic passage between the first line of infusion (8) and the second line of infusion (13) of at least one fluid to be administered (16) to a patient; wherein the tubular element (4) comprises at least one containment chamber (17) configured to house at least one sock sealing element (18) which consists of a single body piece made of an elastically deformable material and shod by close fitting around the male element (10), the sock sealing element (18) being movable as a result of the pressure exerted by the fluid to be administered in the passage from the first portion (3) to the second portion (9), between a closed position and an open position, wherein the second opening (14) is cleared to allow the fluid-operated communication between the first line of infusion (8) and the second line of infusion (13).

Description

[0001] CONNECTOR FOR MEDICAL, DIAGNOSTIC AND PHYSIOLOGICAL FLUID CONTAINERS

[0002] Technical Field

[0003] The present invention relates to a connector for medical, diagnostic and physiological fluid containers.

[0004] Background Art

[0005] With special reference to the medical field, a need is known to connect lines of infusion together in order to allow the transfer and / or mixing of fluids contained therein.

[0006] These lines of infusion may be of different types; in the context of this disclosure, the term “lines of infusion” relates to any device allowing the transfer of drugs, contrast agents, blood, or any other physiological / medical fluid and which consists e.g. of flexible bags, bottles, syringes, tubes, etc.

[0007] The lines of infusion usually comprise a hooking portion which can be coupled to a connector.

[0008] The connectors of known type are substantially valves which, once opened, allow the fluid-operated connection between the lines of infusion connected to the connectors themselves.

[0009] Specifically, the connectors of known type comprise a hollow body having an upper inlet which can be coupled to a first line of infusion and a lower inlet which can be coupled to a second line of infusion.

[0010] The aforementioned inlets are usually located at two opposite ends of the hollow body and are such that both couplings with the lines of infusion are removable. With particular reference to the administration of contrast agents, the upper inlet is coupled to a first multi-patient line of infusion and the lower inlet is coupled to a second line of infusion connected to a patient.

[0011] In detail, the hollow body forms internally a pointed element coated by a sealing element made of a flexible material, usually elastic in nature, and adapted to plug the upper inlet when not associated with the first line of infusion; in this configuration, the connector is closed and does not allow the passage of fluids. When the hollow body is coupled to the first line of infusion, the sealing element is pressed by a hooking portion being in the first line of infusion and slides along the outer wall of the pointed element.

[0012] In this way, the pointed element is uncovered and enters the hooking portion, thus allowing the fluid-operated connection between the first line of infusion connected to the upper opening and the second line of infusion connected to the lower opening.

[0013] Patent documents WO2015044834A1 and WO2015044835A1 show a particular type of connectors made of only two pieces: the hollow body and the sealing element.

[0014] The hollow body is obtained by plastic molding and has, at least initially, an enlarged upper opening to allow the insertion of the sealing element during the assembly of the connector.

[0015] Once the sealing element has been inserted, the hollow body is deformed, e.g. by heating it to soften the plastic, so as to obtain a folded portion narrowing the upper opening and preventing the sealing element from escaping from the hollow body. The connectors of known type do have some drawbacks.

[0016] In this regard, it is important to note that it is essential that the passage of fluids between the lines of infusion interconnected through a connector takes place within a closed circuit.

[0017] In particular, the lines of infusion and the connector must be in fluid-operated communication with each other but must be completely isolated from the external environment; it is very important that this condition is maintained throughout the entire phase of fluid-operated communication between the lines of infusion themselves.

[0018] The upper opening and the first line of infusion are coupled to each other by simply inserting the hooking portion into the upper opening itself.

[0019] Sometimes the hooking portion of the first line of infusion and the upper opening of the hollow body comprise locking means, e.g. of the Luer-lock type, provided with threads that promote the mutual and stable union thereof.

[0020] Sometimes, on the other hand, the hooking portion exclusively consists of a tubular stretch without threads and of Luer-lock coupling systems; this is the case, e.g., with traditional syringes having a fluid inlet and outlet end consisting exclusively of a truncated cone-shaped tube.

[0021] It is easy to appreciate that the association between a traditional syringe without Luer-lock and the connector of known type is rather weak and easily removable during use of the connector itself

[0022] In these cases, the first line of infusion often loses its grip on the upper opening, causing the hooking portion of the first line of infusion to slip out of the upper opening, either completely or partly, with the consequent leakage of fluids, which may become contaminated with bacteria due to the contact with the external environment, thus becoming hazardous to patient health and therefore unusable. This circumstance is particularly relevant with regard to the administration of contrast agents, which are administered at pressures of approximately 25 bar and which have high viscosity.

[0023] Specifically, it is essential to ensure the mechanical and hydraulic tightness of the device in order to prevent pressure drops and accidental release of the first line of infusion from the second one, thus resulting in fluid leakage.

[0024] Furthermore, fluids leaking from the circuit can come into direct contact with healthcare workers handling the connector, thus exposing them to biological or chemical risks.

[0025] In this regard, the case should be considered where the fluids handled are, e.g., blood or other bodily fluids; direct contact with them by an operator may expose them to the risk of contracting serious diseases.

[0026] Furthermore, the case should be considered where one of the lines of infusion contains, e.g., chemotherapy drugs or contrast agents, which are known to be toxic and, therefore, can cause serious effects in people in case of direct exposure. Furthermore, if one of the lines of infusion is directly connected to a patient’s circulatory system, the loss of adhesion between the upper opening and the hooking portion of the first line of infusion can cause reflux of the patient’s blood, which can be very dangerous to the health of the patient involved.

[0027] All of the aforementioned drawbacks are particularly noticeable in the connectors shown in patent documents No. WO2015044834A1 andNo. WO2015044835A1. In these connectors, the upper opening which, as mentioned, is obtained by deforming and narrowing a folded portion, cannot have the exact conformation and calibrated dimensions that would allow it to interlock with the hooking portion of a traditional syringe.

[0028] Description of the Invention

[0029] The main aim of the present invention is to devise a connector for medical, diagnostic and physiological fluid containers which allows ensuring the mechanical and hydraulic seal of the device, thus limiting the accidental release of the hooking portion of the first line of infusion with respect to the upper opening of the connector itself

[0030] Another object of the present invention is to devise a connector for medical, diagnostic and physiological fluid containers which allows limiting the occurrence of fluid leakage from the connector itself and from the lines of infusion, thus reducing the risk of bacterial contamination of the fluids themselves and at the same time limiting the negative effects on the health of the patients involved.

[0031] Furthermore, another object of the present invention is to devise a connector for medical, diagnostic and physiological fluid containers which allows reducing the level of exposure to biological and chemical hazards for healthcare workers handling the connector connected to the lines of infusion.

[0032] Another object of the present invention is to devise a connector for medical, diagnostic and physiological fluid containers which, in the event of the lines of infusion being directly connected to a patient’s circulatory system, allows reducing blood reflux phenomena.

[0033] Another object of the present invention is to devise a connector for medical, diagnostic and physiological fluid containers which allows the aforementioned drawbacks of the prior art to be overcome with a simple, rational, easy and effective to use, as well as inexpensive solution.

[0034] The aforementioned objects are achieved by the present connector for medical, diagnostic and physiological fluid containers having the characteristics of claim 1. Brief Description of the Drawings

[0035] Other characteristics and advantages of the present invention will become more apparent from the description of a preferred, but not exclusive, embodiment of a connector for medical, diagnostic and physiological fluid containers, illustrated by way of an indicative, yet non-limiting example, in the accompanying drawings, in which:

[0036] Figure 1 is an exploded view of the connector according to the invention;

[0037] Figure 2 is a view of the connector in the position of insertion according to the invention;

[0038] Figure 3 is a view of the connector in the closed position according to the invention;

[0039] Figures 4 and 5 are cross-sectional views of the connector according to the invention during use.

[0040] Embodiments of the Invention

[0041] With particular reference to these figures, reference numeral 1 globally relates to a connector for containers 2 of medical, diagnostic and physiological fluids.

[0042] It should be specified that, in the context of this disclosure, the expression “medical, diagnostic and physiological fluids” relates not only to liquid products but also to viscous products, e.g. pastes and gels, and powdered products, in particular very fine powders with high flowability.

[0043] In the particular embodiment shown in the figures, the container 2 is of the type of an infusion bag, which is of a well known type to those skilled in the art.

[0044] The connector 1 comprises: a first portion 3 comprising at least one substantially hollow tubular element 4, having a substantially elongated conformation along a central axis 5 and provided with at least one inlet opening 6 couplable to at least one hooking portion 7 of a first line of infusion 8; a second portion 9 associated with the first portion 3 from the opposite side of the inlet opening 6 and comprising at least one male element 10 which is arranged within the tubular element 4, has a substantially elongated conformation along the central axis 5 and is substantially hollow and provided with at least a first opening 12 for the fluidic connection to a second line of infusion 13 and with a second opening 14, opposite the first opening 12, for the fluidic connection to the inlet opening 6; joining means 15 by interlocking adapted to associate the first portion 3 with the second portion 9, wherein the first portion 3 and the second portion 9 are linked together to allow the fluidic passage between the first line of infusion 8 and the second line of infusion 13 of at least one fluid to be administered 16 to a patient.

[0045] According to the invention, the tubular element 4 comprises one containment chamber 17 configured to house a sock sealing element 18 consisting of a single body piece made of an elastically deformable material and shod by close fitting around the male element 10, wherein the sock sealing element 18 is movable as a result of the pressure exerted by the fluid to be administered 16 in the passage from the first portion 3 to the second portion 9, between a closed position, wherein it covers and seals the second opening 14, and an open position, wherein the second opening 14 is cleared to allow the fluid-operated communication between the first line of infusion 8 and the second line of infusion 13.

[0046] It should be noticed that the first line of infusion 8 corresponds to the so-called multi-patient line and the second line of infusion 13 corresponds to the so-called single-patient line.

[0047] Advantageously, the sock sealing element 18 comprises at least one head portion 19 adapted to abut in the proximity of the male element 10 where the second opening 14 is located.

[0048] As shown in the figures, the containment chamber 17 comprises a bottom portion 30 on which the head portion 19 of the sock sealing element 18 abuts.

[0049] Appropriately, the aforementioned head portion 19 abuts on the male element 10. Preferably, the elastically deformable material is a thermoplastic material.

[0050] In accordance with a preferred embodiment, this material is silicone.

[0051] The head portion 19 comprises at least one notch 20 adapted to allow the passage of the fluid to be administered 16.

[0052] Advantageously, the head portion 19 comprises at least three notches 20 arranged equally spaced apart from each other.

[0053] In detail, the notches 20 are arranged in a radial pattern.

[0054] This means that the three notches 20 define three corresponding flaps 21 which, during the use of the connector 1, as a result of the pressure exerted by the fluid to be administered 16 on each of the aforementioned flaps 21 (Figure 4), causes them to move away from each other, thus allowing the passage of the fluid to be administered itself.

[0055] In other words, the flaps 21 are movable, as a result of the pressure exerted by the fluid to be administered 16 on the same, between a clamping position wherein they are brought close together and coplanar with each other and an opening position wherein they are mutually spaced apart from each other to allow the passage of the fluid to be administered 16.

[0056] The flaps 21 allow preventing the fluid to be administered 16 from leaking during the release of the first portion 3 from the second portion 9.

[0057] In other words, the presence of the three flaps 21 allows the first portion 3 to be safely disconnected from the second portion 9, preventing the loss of drops of fluid to be administered.

[0058] The joining means 15 comprise at least one blocking lug 22 made on the first portion 3 and adapted to abut against the second portion 9 by blocking it by interlocking.

[0059] In detail, the joining means 15 comprise two blocking lugs 22 formed on diametrically opposite portions with respect to the central axis 5 of the first portion 3.

[0060] Alternative embodiments cannot, however, be ruled out wherein the connector 1 may comprise three, four, five, etc. blocking lugs 22.

[0061] Each of the blocking lugs 22 comprises at least one blocking tooth 23.

[0062] More specifically, the second portion 9 comprises at least one guiding portion 24 provided with a side wall 25 which is inclined with respect to the central axis 5 and adapted to promote the sliding of each of the blocking lugs 22.

[0063] It should be noted that in the context of this disclosure, the terms “lateral”, “laterally” and the like are to be meant with reference to an operational configuration wherein the male element 10 is inserted into the tubular element 4 along the direction of insertion D parallel to the central axis 5.

[0064] The guiding portion 24 has a substantially hollow truncated-cone conformation provided with a bottom wall 26 and with a side wall 25.

[0065] This conformation allows each of the blocking lugs 22 to slide along the side wall 25.

[0066] Preferably, the guiding portion 24 comprises at least one abutment edge 27 adapted to abut against each of the blocking teeth 23.

[0067] As can be seen in the figures, the abutment edge 27 is formed where the bottom wall 26 is located.

[0068] In detail, the blocking lugs 22 are movable, as a result of an external force applied thereto, between: a position of insertion wherein they are arranged mutually spaced apart so as to allow the release of the first portion 3 from the second portion 9 (Figure 2); and a position of block wherein the blocking lugs 22 abut against the second portion 9 and the blocking teeth 23 abut against the abutment edge 27 so as to allow the first portion 3 to be joined to the second portion 9 (Figure 3).

[0069] In other words, an operator simply grasps the ends 28 of the blocking lugs 22 and makes the respective blocking teeth 23 slide on the side wall 25 to allow the lugs / ends to move away from each other, until they reach the abutment edge 27 and the first portion 3 is hooked onto the second portion 9.

[0070] The first portion 3 is substantially brought close to the second portion 9 and, during the introduction of the male element 10 into the tubular element 4, the blocking lugs 22 slide along the side wall 25 so as to allow the blocking teeth 23 to be positioned on the abutment edge 27.

[0071] The synergistic combination of the truncated-cone conformation of the side wall 25 with the presence of the blocking lugs 22 allows mechanical sealing to be ensured, thus guaranteeing the blocking thereof even under high pressure.

[0072] Conversely, the first portion 3 is released from the second portion 9 by the operator grasping the ends 28 of the blocking lugs and applying pressure onto the latter, so as to allow them to move apart and the first portion 3 to slip out of the second portion 9.

[0073] In this way, when the first portion 3 moves away from the second portion 9, the flaps 21 return to a coplanar position with each other so as to close the second opening 14 and prevent accidental leakage of the fluid to be administered 16.

[0074] In this regard, it should be noted that the male element 10 runs longitudinally coaxially within the guiding portion 24 and protrudes at least partly from the latter so that, in the position of block, the bottom wall 26 stops against the tubular element 4.

[0075] This ensures the seal between the male element 10 and the bottom wall 26, so that their respective surfaces are in contact to each other.

[0076] In addition, the connector 1 comprises an auxiliary sealing element 29 positioned between the first portion 3 and the second portion 9.

[0077] For this purpose, the auxiliary sealing element 29, in the position of block, is housed within a space defined between the side wall 25 and the tubular element 4.

[0078] Preferably, the auxiliary sealing element 29 has an annular conformation.

[0079] Advantageously, the synergistic combination of the sock sealing element 18 with the auxiliary sealing element 29 allows ensuring hydraulic and mechanical sealing.

[0080] With particular reference to the medical field of contrast agent infusion, 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 the high- viscosity contrast agent.

[0081] Furthermore, this hydraulic seal is necessary in order to guarantee the seal of the device since, when the single-patient line is disconnected, it is necessary to prevent the fluid from leaking from the multi-patient side.

[0082] It has, in practice, been ascertained that the described invention achieves the intended objects.

[0083] It should be noted that the particular expedient of providing a sock sealing element in combination with the auxiliary sealing element and the blocking lugs ensures both hydraulic and mechanical sealing of the device even at high pressures of approximately 25 bar and at a maximum flow rate of 10 ml / sec of a fluid such as the high-viscosity contrast agent.

Claims

CLAIMS1) Connector (1) for medical, diagnostic and physiological fluid containers, comprising: at least a first portion (3) comprising at least one substantially hollow tubular element (4), having a substantially elongated conformation along a central axis (5) and comprising at least one inlet opening (6) couplable to at least one hooking portion (7) of a first line of infusion (8); at least a second portion (9) associated with said first portion (3) from the opposite side of said inlet opening (6) and comprising at least one male element (10) which is arranged within said tubular element (4), has a substantially elongated conformation along said central axis (5) and is substantially hollow and provided with at least a first opening (12) for the fluidic connection to a second line of infusion (13) and with at least a second opening (14), opposite said first opening (12), for the fluidic connection to said inlet opening (6); joining means (15) by interlocking adapted to associate said first portion (3) with said second portion (9), said first portion (3) and said second portion (9) being linked together to allow the fluidic passage between said first line of infusion (8) and said second line of infusion (13) of at least one fluid to be administered (16) to a patient; characterized by the fact that said tubular element (4) comprises at least one containment chamber (17) configured to house at least one sock sealing element (18) which consists of a single body piece made of an elastically deformable material and shod by close fitting around said male element (10), said sock 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, wherein it covers and seals said second opening (14), and an open position, wherein said second opening (14) is cleared to allow the fluid-operated communication between said first line of infusion (8) and said second line of infusion (13).2) Connector (1) according to claim 1, characterized by the fact that said sock sealing element (18) comprises at least one head portion (19) adapted to abut in the proximity of said male element (10) where said second opening (14) is located.3) Connector (1) according to one or more of the preceding claims, characterized by the fact that said head portion (19) comprises at least one notch (20) adapted to allow the passage of said fluid to be administered (16).4) Connector (1) according to one or more of the preceding claims, characterized by the fact that said head portion (19) comprises at least three notches (20) arranged equally spaced apart from each other.5) Connector (1) according to one or more of the preceding claims, characterized by the fact that said notches (20) are arranged in a radial pattern.6) Connector (1) according to one or more of the preceding claims, characterized by the fact that it comprises at least one auxiliary sealing element (29) positioned between said first portion (3) and said second portion (9).7) Connector (1) according to one or more of the preceding claims, characterized by the fact that said joining means (15) comprise at least one blocking lug (22) made on said first portion (3) and adapted to abut against said second portion (9) by blocking it by interlocking.8) Connector (1) according to one or more of the preceding claims, characterized by the fact that said joining means (15) comprise two blocking lugs (22) formed on diametrically opposite portions with respect to the central axis (5) of the first portion (3).9) Connector (1) according to one or more of the preceding claims, characterized by the fact that each of said blocking lugs (22) comprises at least one blocking tooth (23).10) Connector (1) according to one or more of the preceding claims, characterized by the fact that said guiding portion (24) comprises at least one abutment edge (27) adapted to abut against each of said blocking teeth (23).11) Connector (1) according to one or more of the preceding claims, characterized by the fact that said blocking lugs (22) are movable, as a result of an external force applied thereto, between: a position of insertion wherein they are arranged mutually spaced apart so as to allow the release of said first portion (3) from said second portion (9); and a position of block wherein said blocking lugs (22) abut against said second portion (9) and said blocking teeth (23) abut against said abutment edge (27) so as to allow said first portion (3) to be joined to said second portion (9).12) Connector (1) according to one or more of the preceding claims, characterized by the fact that said second portion (9) comprises at least one guiding portion (24) provided with a side wall (25) which is inclined with respect to the central axis (5) and adapted to promote the sliding of each of said blocking lugs (22).13) Connector (1) according to one or more of the preceding claims, characterized by the fact that said guiding portion (24) has a substantially hollow truncated-cone conformation provided with a bottom wall (26) and with said side wall (25).14) Connector (1) according to one or more of the preceding claims, characterized by the fact that said male element (10) runs longitudinally coaxially within said guiding portion (24) and protrudes at least partly from the latter so that, in said position of block, said bottom wall (26) stops against said tubular element (4).15) Connector (1) according to one or more of the preceding claims, characterized by the fact that said auxiliary sealing element (29), in said position of block, is housed within a space defined between said side wall (25) and said tubular element (4).

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