System for dialysis

Abstract

The system (1) for dialysis comprises: - one dialysis machine (2) provided with a pumping device (3) and configured to perform a dialysis treatment on a patient's blood; - one transfer circuit (4) associated with the dialysis machine (2) in a removable manner in a predefined configuration of use and adapted to transfer blood between the dialysis machine (2) and the patient, where the transfer circuit (4) comprises at least one arterial line (6) adapted to convey the arterial blood of the patient and provided with at least one pump tubing (7) installable on the pumping device (3) and at least one venous line (8) adapted to convey the venous blood of the patient and provided with at least one venous tray (9); wherein the transfer circuit (4) comprises joining means (16) adapted to fix the arterial line (6) to the venous line (8) in the predefined configuration of use.

Description

[0001] SYSTEM FOR DIALYSIS

[0002] Technical Field

[0003] The present invention relates to a system for dialysis.

[0004] Background Art

[0005] The systems for dialysis of known type comprise a dialysis machine and a disposable transfer circuit, a dialyzer device and other devices to generate dialysate. The transfer circuit is replaced after each treatment and allows extracorporeal circulation and contributes to the transmission of the patient’s vital parameters, such as arterial and venous pressure.

[0006] The systems for dialysis of known type involve the use of a transfer circuit provided with the so-called “traditional” lines, namely an arterial line A and a separate venous line V, shown by way of example in Figure 1, which are installed one at a time on the dialysis machine by an experienced operator.

[0007] In recent years, however, there has been a trend toward simplifying dialysis treatment. On the one hand, this allows for the of dialysis treatment to enable it to be carried out in a more comfortable home environment for the patient and to facilitate treatment even in settings far from specialized dialysis centers, and on the other hand, it allows for the provision and management of systems for dialysis even in developing countries, where there may be a shortage of experienced personnel.

[0008] The use of traditional lines, therefore, is not suitable for this purpose.

[0009] For this reason, solutions are also known to partly solve the aforementioned drawbacks, namely the transfer circuits provided with “compact” lines in which the components are already assembled and integrated in a box or organizer prepared for installation on the relevant dialysis machine.

[0010] Such compact lines are easy to use and install, but at the production level they involve high design and production costs, which are different for each model of dialysis machine and are therefore more expensive than “traditional” lines. Therefore, it is evident how systems for dialysis are susceptible to refinements. Description of the Invention

[0011] The main aim of the present invention is to devise a system for dialysis which allows quick and easy assembly of blood lines to the dialysis machine.

[0012] Another object of the present invention is to devise a system for dialysis which allows practical use even by unskilled personnel.

[0013] A further object of the present invention is to devise a system for dialysis which allows keeping design and production costs down.

[0014] Another object of the present invention is to devise a system for dialysis which allows the aforementioned drawbacks of the prior art to be overcome within the framework of a simple, rational, easy and effective to use as well as affordable solution.

[0015] The above objects are achieved by this system for dialysis having the characteristics of claim 1.

[0016] Other characteristics and advantages of the present invention will become more apparent from the description of a preferred, but not exclusive, embodiment of a system for dialysis, illustrated by way of an indicative, yet non-limiting example in the accompanying tables of drawings in which:

[0017] Figure 1 is a schematic representation of a transfer circuit of known type;

[0018] Figure 2 is a view of the system for dialysis in accordance with a first embodiment;

[0019] Figure 3 is a view of the system for dialysis in accordance with a second embodiment;

[0020] Figures 4-7 are views of the system for dialysis in accordance with a third embodiment;

[0021] Figure 8 is a detailed view of a fastening element in accordance with the third embodiment;

[0022] Figure 9 is a view of the system for dialysis in accordance with a fourth embodiment;

[0023] Figure 10 is a view of the system for dialysis in accordance with a fifth embodiment.

[0024] Embodiments of the Invention

[0025] With particular reference to these figures, reference numeral 1 globally denotes a system for dialysis.

[0026] The system 1 comprises: at least one dialysis machine 2 provided with a pumping device 3 and configured to perform a dialysis treatment on a patient’s blood; at least one transfer circuit 4 fastened to the dialysis machine 2 in a predefined configuration of use and adapted to transfer blood between the dialysis machine 2 and the patient.

[0027] In this regard, it is specified that the expression “configuration of use” means the predefined configuration of installation which is determined by the set of fastening members 5 arranged on the dialysis machine 2 such as e.g. grooves, hooks, clips, etc. Before use, the transfer circuit 4 is installed on the dialysis machine 2 by interlocking, or similar ways, in the above-mentioned fastening members 5.

[0028] The transfer circuit 4 is preferably a sterile disposable device which is removed from the dialysis machine 2 at the end of use and properly disposed of.

[0029] The transfer circuit 4 comprises at least two blood lines 6,8.

[0030] Specifically, the transfer circuit 4 comprises at least one arterial line 6 adapted to convey the arterial blood of the patient and provided with at least one pump tubing 7 installable on the pumping device 3 and with at least one venous line 8 adapted to convey the venous blood of the patient and provided with at least one venous tray 9.

[0031] The arterial line 6 and the venous line 8 are of a type known to the technician in the field and both comprise at least one main pipe which can be connected to the dialysis machine 2 on one side and to the patient on the other side.

[0032] In detail, the blood lines 6,8, being placed in direct contact with the patient’s blood, are made of a biocompatible material.

[0033] The arterial line 6 comprises at least a first arterial tract 10 connected to the pump tubing 7 and adapted to receive the arterial blood from the patient, and at least a second arterial tract 11 connected to the pump tubing 7 and adapted to transfer the arterial blood to a dialyzer device with which the dialysis machine 2 is provided, not shown in detail in the figures. In the present case, the pumping device 3 is of the type of a peristaltic pump.

[0034] In the configuration of use, the two arterial tracts 10, 11 are arranged substantially horizontal and parallel to each other and the pump tubing 7 is partly wrapped, in a semicircle, around the pumping device 3.

[0035] Each of the arterial tracts 10,11 comprises a respective extremal portion and a connector element 12, connected to the respective extremal portion, for the connection to the pump tubing 7.

[0036] The venous line 8 comprises at least a first venous tract 13 connected to the venous tray 9 and adapted to receive venous blood from the dialyzer device and at least a second venous tract 14, connected to the venous tray 9 and adapted to transfer the venous blood to the patient.

[0037] In the configuration of use, the two venous tracts 13,14 are arranged substantially horizontally and parallel to each other, and the venous tray 9 runs transversely to them. Each of the venous tracts 13,14 comprises a respective extremal portion. The venous tray 9 comprises a pair of linking portions 15, at the ends of the venous tray itself, each connected to a respective extremal portion of a venous tract 13, 14.

[0038] The linking portion 15 can be made integrally in the venous tray 9 or as a separate body. Preferably, one of the linking portions 15 is made integrally in the venous tray 9 and the other of the linking portions 15 is made as a separate body.

[0039] The arterial line 6 and the venous line 8 may also comprise secondary pipes that branch off from the main pipe and connectable to additional devices, e.g., for the sensing of certain blood parameters or for any sampling of the blood itself.

[0040] According to the invention, the transfer circuit 4 comprises joining means 16 adapted to fix the arterial line 6 to the venous line 8 in the predefined configuration of use.

[0041] In actual facts, the joining means 16 prepare the arterial line 6 and the venous line 8 already in the mounting position on the dialysis machine 2 and allow easy installation thereof even by inexperienced operators.

[0042] By doing so, it is possible to allow practical installation of even the so-called “traditional” lines. Conveniently, the joining means 16 are arranged externally to the arterial line 6 and to the venous line 8.

[0043] In other words, the joining means 16 are not intended to come into contact with the patient’s blood. Therefore, the joining means 16 can also be made of a nonbiocompatible material, thus allowing for a significant reduction in the manufacturing costs.

[0044] In accordance with the embodiments shown in the figures, the joining means 16 are positioned between the arterial line 6 and the venous line 8 where the pump tubing 7 and the venous tray 9 are respectively located.

[0045] In fact, the pump tubing 7 and the venous tray 9 need to be arranged in well- defined positions and the presence of the joining means 16 implies that the installation of the pump tubing 7 and of the arterial line 6 also determines the correct positioning of the venous tray 9 and of the venous line 8 and vice versa. Advantageously, the joining means 16 comprise at least one fastening element 17, 18 provided with a first retaining portion 19 adapted to receive the arterial line 6 and at least a second retaining portion 20 adapted to receive the venous line 8.

[0046] In accordance with a preferred embodiment, the fastening element 17,18 is associated with the blood lines 6,8 in a removable manner. The retaining portions 19,20 are then configured to allow easy attachment / removal of the blood lines 6,8. For example, the retaining portions 19,20 can be conformed to a crescent shape. In this sense, therefore, the fastening element 17,18 is also attachable to “traditional” blood lines.

[0047] Alternatively, the fastening element 17, 18 is locked together with the blood lines 6,8. In this case, the retaining portions 19,20 have a cylindrical conformation and are mounted on the blood lines 6,8 during the production phases of the transfer circuit 4.

[0048] Conveniently, the at least one fastening element 17,18 is configured to maintain the arterial line 6 posteriorly to the venous line 8. In detail, the first retaining portion 19 is arranged posteriorly to the second retaining portion 20. Again, in the configuration of use, the first retaining portion 19 faces the dialysis machine 2 and the second retaining portion 20 faces outward. Alternatively, the at least one fastening element 17,18 is configured to maintain the arterial line 6 anteriorly to the venous line 8. In detail, the first retaining portion 19 is arranged anteriorly to the second retaining portion 20. Again, in the configuration of use, the first retaining portion 19 faces outwards and the second retaining portion 20 faces the dialysis machine 2.

[0049] The fastening elements 17,18 are substantially configured to arrange the blood lines 6,8 according to the conformation of the dialysis machine 2 in order to reduce deformation of the tracts themselves that could result in undesirable mechanical stresses.

[0050] Conveniently, the first retaining portion 19 is associated with one of either the arterial tracts 10,11 or the pump tubing 7. Preferably, the first retaining portion

[0051] 19 is associated with one of either the extremal portions of the arterial tracts 10, 11 or the connector element 12.

[0052] Similarly, the second retaining portion 20 is associated with one of either the venous tracts 13,14 or the venous tray 9. Preferably, the second retaining portion

[0053] 20 is associated with one of either the extremal portions of the venous tracts 13,14 or the linking portion 15.

[0054] In actual facts, the fastening element 17,18 can be associated, on the one hand, with the extremal portion of an arterial tract 10,11, with a connector element 12 or with the pump tubing 7 and, on the other hand, with the extremal portion of a venous tract 13,14, with a linking portion 15 or with the venous tray 9.

[0055] The arrangement of the fastening element 17,18 depends on the geometrical dimensions of the tubing 7 and of the tray 9.

[0056] As shown above, the pump tubing 7 is mounted where the pumping device 3 is located. The venous tray 9, on the other hand, abuts against an abutment surface

[0057] 21 of the dialysis machine 2, adjacent to the pumping device 3.

[0058] The abutment surface 21 lies on a plane transverse to a horizontal plane of reference. The abutment surface 21 can substantially lie on a vertical plane or on a plane inclined with respect to the horizontal plane of reference.

[0059] Consequently, in the former case, the venous tray 9 runs along a substantially vertical direction while in the latter case the venous tray 9 runs along an inclined direction with respect to the horizontal plane of reference.

[0060] In this latter case, the at least one fastening element 17,18 is configured to maintain the venous tray 9 inclined with respect to the horizontal plane of reference. This embodiment makes it possible to reduce the turbulence that is normally generated when blood from the first venous tract 13 drops vertically on the blood already present in the venous tray 9. Therefore, the joining means 16 can also help to fix this technical problem. In fact, the flowing of the blood over the walls of the venous tray, rather than falling directly on the blood already present within it, makes it possible to reduce the formation of turbulence and the incorporation of air bubbles in the blood, which can induce coagulation of the same.

[0061] Specifically, the abutment surface 21 is inclined with respect to the horizontal plane of reference by an angle of between 60° and 90° and, preferably, of between 70° and 80°.

[0062] Conveniently, the at least one fastening element 17,18 comprises at least one connecting portion 22 adapted to operate in conjunction with a respective seat 23 with which the dialysis machine 2 is provided. In actual facts, once the transfer circuit 4 is installed on the dialysis machine 2, the connecting portion 22 is arranged where the seat 23 is located. The connecting portion 22 and the seat 23 may have a constrained coupling, e.g. by interlocking, magnetic or the like, and can help maintain the transfer circuit 4 in the predefined configuration of use.

[0063] The dialysis machine 2 appropriately comprises sensor means, not shown in detail in the figures, associated with the seat 23 and adapted to sense the presence of the at least one fastening element 17,18. For example, the sensor means may comprise a presence sensor configured to sense the presence of the connecting portion 22 within the seat 23 and to allow the dialysis machine 2 to be operated only when positive. As an alternative or in combination thereof, the sensor means may comprise a recognition sensor, such as e.g. an RFID sensor, configured to recognize a relevant identifier associated with the connecting portion 22. In this way, in addition to sensing the presence of the transfer circuit, the sensor means may also capture additional information, such as e.g., the transfer circuit production data, patient data or other information.

[0064] The machine 2 may also comprise at least one actuator device 26 arranged in the seat 23 and configured to activate the sensor means and / or to cause the ejection of the fastening element 17,18 from the seat itself

[0065] In actual facts, the actuator device 26 may be of the type of a push-button, which can be positioned between a first position, wherein it is pushed by the fastening element 17,18 when placed in the seat 23 and contacts and activates the sensor means, and a second position, wherein it pushes the fastening element 17,18 and promotes the ejection thereof when the transfer circuit 4 is removed.

[0066] As shown above, the coupling between the connecting portion 22 and the seat 23 can help maintain the transfer circuit 4 in the predefined configuration of use.

[0067] In this regard, the dialysis machine 2 may further comprise supporting means 24 adapted to hold the venous tray 9. The supporting means 24 may comprise, e.g., a lid adapted to partly or totally cover the venous tray 9.

[0068] The supporting means 24 can be made as a single body piece with the screen 25 with which the dialysis machine 2 is provided for the protection of the pumping device 3.

[0069] Advantageously, the joining means 16 comprise at least a first fastening element

[0070] 17 and at least a second fastening element 18.

[0071] The presence of two fastening elements 17,18 allows giving greater stability to the arterial line 6 and to the venous line 8 and maintains them firmly in the configuration of use, thus ensuring proper mounting on the dialysis machine 2.

[0072] In detail, the first retaining portion 19 of the first fastening element 17 is associated with one of either the first arterial tract 10 or the pump tubing 7, and the second retaining portion 20 of the first fastening element 17 is associated with one of either the second venous tract 14 or the venous tray 9.

[0073] At the same time, the first retaining portion 19 of the second fastening element

[0074] 18 is associated with one of either the second arterial tract 11 or the pump tubing 7, and the second retaining portion 20 of the second fastening element 18 is associated with one of either the first venous tract 13 or the venous tray 9.

[0075] More details of the preferred embodiments of this system for dialysis 1 will now be described with reference to the attached tables of drawing.

[0076] In Figure 2, a first embodiment is shown, wherein the joining means 16 comprise only one fastening element 17,18 positioned between the first arterial tract 10 and the second venous tract 14. In detail, the joining means 16 comprise only the first fastening element 17.

[0077] In accordance with this embodiment, the first retaining portion 19 is arranged posteriorly to the second retaining portion 20.

[0078] The first retaining portion 19 intercepts the extremal portion of the first arterial tract 10 while the second retaining portion 20 abuts against the linking portion 15 of the venous tray 9.

[0079] The joining means 16 in accordance with the first embodiment allow a high degree of freedom of movement between the two blood lines 6,8 and enable easy installation of the transfer circuit 4 on the dialysis machine 2. In addition, the fastening means are characterized by remarkable simplicity; in fact, the retaining portions 19,20 are crescent-shaped and allow quick coupling by interlocking to the respective blood lines 6,8.

[0080] In Figure 3, a second embodiment is shown that differs from the previous one by the fact that the joining means 16 comprise the first fastening element 17 and the second fastening element 18.

[0081] The joining means 16 in accordance with this second embodiment ensure correct positioning of the transfer circuit 4 in the configuration of use.

[0082] In Figures 4 to 7, a third embodiment is shown wherein the abutment surface 21 is inclined and the second fastening element 18 is configured to maintain the venous tray 9 inclined in turn.

[0083] In this case, the first fastening element 17 has the first retaining portion 19 placed posteriorly to the second retaining portion 20. The first fastening element 17, therefore, is configured to maintain the first arterial tract 10 posteriorly to the second venous tract 14.

[0084] In addition, the second retaining portion 20 is configured to intercept the extremal portion of the second venous tract 14.

[0085] In accordance with this embodiment, in addition, the second fastening element 18 is configured to retain the venous tray 9 and the second arterial tract 11. In detail, the second fastening element 18 comprises a housing defining the second retaining portion 20 and adapted to house the venous tray 9. In this case, the first retaining portion 19 is placed anteriorly to the second retaining portion 20 and the second fastening element 18 is configured to maintain the second arterial tract 11 anteriorly to the first venous tract 13. In detail, both retaining portions 19,20 of the second fastening element 18 face outwards and, in use, the second arterial tract 11 maintains the venous tray 9 within the housing.

[0086] In accordance with this embodiment, moreover, the connecting portion 22 and the seat 23 define a constrained coupling, as shown in detail in Figures 7 and 8. Specifically, the seat 23 is recessed and the connecting portion 22 is protruding and insertable into the seat 23 by interlocking.

[0087] In Figures 9 and 10, a fourth and a fifth embodiment are shown as variants of the previous embodiments, wherein the dialysis machine 2 comprises the supporting means 24 adapted to hold the venous tray 9. The supporting means 24 comprise a lid, made as a single body piece with the screen 25, and are arranged to cover the venous tray 9 totally (Figure 9) or only partly (Figure 10).

[0088] According to a further aspect, the present invention also relates to a transfer circuit 4, as previously described, for blood transfer between a dialysis machine and a patient.

[0089] Specifically, the transfer circuit 4 comprises: at least one arterial line 6 adapted to carry the arterial blood of a patient and provided with at least one pump tubing 7 connectable to a pumping device 3 of a dialysis machine 2; and at least one venous line 8 adapted to carry the venous blood of said patient and provided with at least one venous tray 9; where, in accordance with the invention, the transfer circuit 4 further comprises joining means 16 adapted to fasten the arterial line 6 and the venous line 8 to each other in a predefined configuration of use.

[0090] It has in practice been ascertained that the described invention achieves the intended objects, and in particular the fact is emphasized that the system for dialysis according to the invention, allows for quick and easy assembly of the blood lines to the dialysis machine.

[0091] In addition, the present system for dialysis allows convenient use even by unskilled personnel. Finally, this system for dialysis keeps design and production costs down.

Claims

CLAIMS1) System (1) for dialysis comprising: at least one dialysis machine (2) provided with a pumping device (3) and configured to perform a dialysis treatment on a patient’s blood; at least one transfer circuit (4) associated with said dialysis machine (2) in a removable manner in a predefined configuration of use and adapted to transfer blood between said dialysis machine (2) and the patient, where said transfer circuit (4) comprises at least one arterial line (6) adapted to convey the arterial blood of said patient and provided with at least one pump tubing (7) installable on said pumping device (3) and at least one venous line (8) adapted to convey the venous blood of said patient and provided with at least one venous tray (9); characterized by the fact that said transfer circuit (4) comprises joining means (16) adapted to fix said arterial line (6) to said venous line (8) in said predefined configuration of use.2) System (1) according to claim 1, characterized by the fact that said joining means (16) are arranged externally to said arterial line (6) and to said venous line (8).3) System (1) according to one or more of the preceding claims, characterized by the fact that said joining means (16) are positioned between said arterial line (6) and said venous line (8) where said pump tubing (7) and said venous tray (9) are respectively located.4) System (1) according to one or more of the preceding claims, characterized by the fact that said joining means (16) comprise at least one fastening element (17,18) provided with a first retaining portion (19) adapted to receive said arterial line (6) and at least a second retaining portion (20) adapted to receive said venous line (8).5) System (1) according to one or more of the preceding claims, characterized by the fact that said arterial line (6) comprises at least a first arterial tract (10) connected to said pump tubing (7) and adapted to receive the arterial blood from the patient and at least a second arterial tract (11) connected to said pump tubing(7) and adapted to transfer the arterial blood to a dialyzer device with which said dialysis machine (2) is provided, said first retaining portion (19) being associated with one of either said arterial tracts (10,11) or said pump tubing (7).6) System (1) according to one or more of the preceding claims, characterized by the fact that each of said arterial tracts (10, 11) comprises a respective extremal portion and a connector element (12), connected to the respective extremal portion, for the connection to said pump tubing (7), said first retaining portion (19) being associated with one of either said extremal portions of said arterial tracts (10, 11) or said connector element (12).7) System (1) according to one or more of the preceding claims, characterized by the fact that said venous line (8) comprises at least a first venous tract (13) connected to said venous tray (9) and adapted to receive venous blood from said dialyzer device and at least a second venous tract (14), connected to said venous tray (9) and adapted to transfer the venous blood to the patient, said second retaining portion (20) being associated with one of either said venous tracts (13,14) or said venous tray (9).8) System (1) according to one or more of the preceding claims, characterized by the fact that each of said venous tracts (13,14) comprises a respective extremal portion and by the fact that said venous tray (9) comprises a pair of linking portions (15), at the ends of the venous tray itself, each connected to a respective extremal portion of a venous tract (13, 14), said second retaining portion (20) being associated with one of either said extremal portions of the venous tracts (13,14) and said linking portion (15).9) System (1) according to one or more of the preceding claims, characterized by the fact that said at least one fastening element (17,18) comprises at least one connecting portion (22) adapted to operate in conjunction with a respective seat (23) with which said dialysis machine (2) is provided, and by the fact that said dialysis machine (2) comprises sensor means associated with said seat (23) and adapted to sense the presence of said at least one fastening element (17,18).10) System (1) according to one or more of the preceding claims, characterized by the fact that said dialysis machine (2) comprises at least one actuator device(26) arranged in said seat (23) and configured to activate the sensor means and / or to cause the ejection of the fastening element (17,18) from the seat itself11) System (1) according to one or more of the preceding claims, characterized by the fact that said at least one fastening element (17,18) is configured to maintain said venous tray (9) inclined with respect to a horizontal plane of reference.12) System (1) according to one or more of the preceding claims, characterized by the fact that said at least one fastening element (17,18) is configured to maintain said arterial line (6) posteriorly to said venous line (8).13) System (1) according to one or more of the preceding claims, characterized by the fact that said at least one fastening element (17,18) is configured to maintain said arterial line (6) anteriorly to said venous line (8).14) System (1) according to one or more of the preceding claims, characterized by the fact that said joining means (16) comprise at least a first fastening element(17) and at least a second fastening element (18).15) System (1) according to one or more of the preceding claims, characterized by the fact that the first retaining portion (19) of said first fastening element (17) is associated with one of either said first arterial tract (10) or said pump tubing (7) and the second retaining portion (20) of the first fastening element (17) is associated with one of either said second venous tract (14) or said venous tray (9).16) System (1) according to one or more of the preceding claims, characterized by the fact that the first retaining portion (19) of said second fastening element(18) is associated with one of either said second arterial tract (11) or said pump tubing (7) and the second retaining portion (20) of said second fastening element (18) is associated with one of either said first venous tract (13) or said venous tray (9).17) Transfer circuit (4) for the blood transfer between a dialysis machine and a patient, where said transfer circuit (4) comprises: at least one arterial line (6) adapted to carry the arterial blood of a patient and provided with at least one pump tubing (7) connectable to a pumping deviceat least one venous line (8) adapted to carry the venous blood of said patient and provided with at least one venous tray (9); characterized by the fact that it comprises joining means (16) adapted to fasten said arterial line (6) and said venous line (8) to each other in a predefined configuration of use.

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