MANIFOLD FOR DIALYSIS MACHINES AND EQUIPMENT AND DIALYSIS MACHINE OR EQUIPMENT COMPRISING SAID MANIFOLD

Abstract

A manifold for the circulation of fluids along predetermined circulation paths or circuits, for example, for extracorporeal dialysis machines. The manifold comprises a main body with a plurality of inner channels mutually connected to define the predetermined circulation paths, the predetermined circulation paths communicating with the exterior of the main body by way of at least one inlet and at least one outlet adapted to be connected to component parts and/or tubing of an extracorporeal dialysis machine, and dialysis machine equipped with the aforesaid manifold.

Claims

1. A manifold for the circulation of fluids along predetermined circulation paths or circuits for extracorporeal dialysis machines, said manifold comprising: a main body with a plurality of inner channels mutually connected to define said predetermined circulation paths, wherein said predetermined circulation paths communicating with an exterior of said main body via at least one inlet and at least one outlet adapted to be connected to component parts and/or tubing of an extracorporeal dialysis machine, said main body includes a first outer multilayered body and a second outer multilayered body superimposed on said first outer multilayered body, said two bodies being mutually and rigidly fastened, the first outer multilayered body has at least a first groove extending both from a surface thereof in contact with the second outer multilayered body, over a depth lower than a whole thickness thereof, and perpendicularly to said whole thickness, and said first through-groove, on a side opposite to said first multilayered body is closed by said second outer multilayered body.

2. The manifold according to claim 1, wherein said first outer multilayered body has at least a first through hole extending between an outer surface of said first outer multilayered body opposite to the surface in contact with said second outer multilayered body and said first groove of said first outer multilayered body, said first through hole putting in communication with the exterior a channel or a portion thereof of said plurality of inner channels.

3. The manifold according to claim 2, wherein said at least a first through hole of said first outer multilayered body defines a seat wherein a monitoring component of said circulation of fluids, is housed, and the respective monitoring component is housed in said seat to be in interference with the flow of said fluids in said inner channel or portion thereof.

4. The manifold according to claim 2, wherein said first outer multilayered body has a plurality of said first through holes each positioned to put in communication with the exterior a channel or a portion thereof of said plurality of inner channels, and in that at least two of said first through holes of said first outer multilayered body define each a seat wherein a monitoring component of said circulation of fluids is housed, and each of said at least two seats the respective monitoring component is housed so as to be in interference with the flow of said liquids.

5. The manifold according to claim 2, wherein at least one of said seats the respective component is housed to be accessible from the exterior.

6. The manifold according to claim 4, wherein at least two of said plurality of first through holes of said first outer multilayered body define an inlet and an outlet, respectively, for the introduction and the discharge of said fluids, respectively, into and from an inner channel or a portion thereof, respectively.

7. The manifold according to claim 6, wherein said inlet and/or said outlet are shaped to be put in fluid communication with component parts of a dialysis machine.

8. The manifold according to claim 7, wherein a connecting tube is housed in at least said inlet and/or said outlet.

9. The manifold according to claim 1, wherein said main body has at least a first and a second circulation circuit or path, each connected to the exterior via an inlet and an outlet defined by corresponding through holes of said first outer multilayered body.

10. The manifold according to claim 9, wherein said first and second circulation circuits or paths have a common section.

11. The manifold according to claim 1, wherein said main body comprises an intermediate multilayered body interposed between said first and second outer multilayered bodies and said intermediate multilayered body has at least a second groove in correspondence of said first groove of the first outer multilayered body extending both over the whole thickness of said intermediate multilayered body in a passing-through manner, and perpendicularly to said thickness, the two first and second grooves therefore defining an inner channel for the circulation of said fluids.

12. A dialysis machine comprising means configured to and/or adapted to allow the extracorporeal circulation of fluids, along pre-determined circulation circuits or paths, wherein said circulation circuits or paths are defined at least partially by the manifold according to claim 1.

13. The machine according to claim 12, wherein said manifold defines at least a first circulation circuit or path whose inlet is connectable to water mains, and at least one pressure sensor and at least one pressure regulator are arranged along said at least a first circulation circuit or path.

14. The machine according to claim 13, wherein said at least a first circulation circuit or path is connected to a tank to allow the introduction of fluids from said at least a first circuit to said tank and the re-introduction of fluids from said tank into said at least a first circuit.

15. The machine according to claim 14, wherein one or more flow and/or conductivity and/or pressure sensors are arranged along said at least a first circulation circuit or path, downstream of said tank.

16. The machine according to claim 14, wherein said manifold defines at least a second circulation circuit or path connected to said tank to allow the introduction of fluids from said at least a second circuit to said tank and the re-introduction of fluids from said tank into said at least a second circuit.

17. The machine according to claim 14, wherein said manifold defines at least one third circulation circuit or path connected both to said tank and to a bicarbonate cartridge, and said at least one third circuit is configured and/or adapted to allow the introduction of liquids from said tank to said cartridge and the discharge of liquids from said cartridge.

18. The manifold according to claim 2, wherein said monitoring component is a pressure and/or temperature and/or conductivity and/or flow sensor.

19. The manifold according to claim 6, wherein said inlet and/or said outlet are shaped to be put in fluid communication with pumps, and/or filters, and/or tanks, and/or tubing.

20. A dialysis machine comprising means configured to and/or adapted to allow the extracorporeal circulation of blood, and/or dialyzing solutions, and/or saline solutions, along pre-determined circulation circuits or paths, wherein said circulation circuits or paths are defined at least partially by the manifold according to claim 1.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0042] The present invention will be clarified below by means of the description of some of the embodiments thereof depicted in the attached drawings. It should be noted, however, that the present invention is not limited to the embodiments depicted in the attached drawings; conversely, all those variants or modifications of the embodiments depicted and described below, which will be apparent, obvious and evident to those skilled in the art, are within the field and the scope of the present invention. In particular, in the attached drawings:

[0043] FIG. 1 shows a diagram of a dialysis machine according to an embodiment of the present invention;

[0044] FIGS. 2a and 2b each show the developments of fluid circulation circuits or paths in the dialysis machine according to an embodiment of the present invention;

[0045] FIGS. 3a and 3b each show the developments of further fluid circulation circuits or paths in the dialysis machine according to an embodiment of the present invention;

[0046] FIGS. 4a and 4b each show the developments of further fluid circulation circuits or paths in the dialysis machine according to an embodiment of the present invention;

[0047] FIGS. 5a, 5b and 5c each show a perspective view of a first multilayered body, an intermediate multilayered body and a second multilayered body, respectively, of a manifold according to an embodiment of the present invention;

[0048] FIGS. 6a and 6b each show a transverse sectional view of a manifold according to an embodiment of the present invention;

[0049] FIG. 7 shows a perspective view of a dialysis machine according to an embodiment of the present invention.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0050] The present invention finds particular and effective application in the case of dialysis machines and/or equipment, this being the reason for which, below, the present invention will be described with particular reference to the application thereof to the case of dialysis machines and/or equipment, the possible applications of the present invention being, however, not limited to the case of dialysis machines or equipment. FIG. 1 shows the hydraulic diagram of a dialysis machine according to an embodiment of the present invention.

[0051] As shown, the machine 400 comprises an entry or inlet 401 for the introduction of water from the water mains, an outlet 402 for the post-treatment discharge of dialysis liquids, an entry or inlet 404 connectable to the patient for the introduction into the machine 400 of the untreated blood of the patient him or herself, and an outlet 403 connectable to the patient for the post-treatment re-introduction of the treated blood into the body of the patient him or herself.

[0052] The machine 400, still as shown, further comprises canonical and conventional components of dialysis machines, such as, for example, tanks 405, 406, 407 and 408 for liquids, a filter 409 and a bicarbonate cartridge 410. The aforesaid canonical components are mutually connected by means of liquid circulation circuits or paths, along which both active components are arranged, such as pumps, valves (one-way and/or two-way and/or three-way) and the like, for moving said liquids, as well as passive components, such as monitoring and/or control components, for example, pressure, temperature, conductivity, flow sensors etc.

[0053] Since the symbols used in the diagram of FIG. 1 are known to those skilled in the art, since the operation of both the passive and the active components of the machine of FIG. 1 is both known to those skilled in the art as well as described briefly below, a detailed description of the aforesaid components is omitted for synthesis purposes. Furthermore, it should be noted that in FIG. 1 the hydraulic diagram is shown of a possible embodiment of the dialysis machine according to the present invention, wherein the present invention is not limited to the example of FIG. 1, but wherein, on the contrary, according to the present invention, the number and type of active and/or passive components, pumps, valves, tanks etc. may vary according to particular needs and/or circumstances, in particular, according to the specific applications of the machine itself.

[0054] As anticipated, in the dialysis machines according to the background art, the components shown in FIG. 1, as mentioned, of variable number and type depending on the particular applications, are mutually connected by means of tubing, in particular, very often, by means of flexible silicone tubes.

[0055] On the contrary, according to the present invention, the components of the machine 400 are mutually connected by means of circuits or paths for the circulation of liquids (blood, water, solutions etc.) at least in part defined by a manifold according to the following methods.

[0056] With reference to FIGS. 5a to 5c, 6a and 6b, a manifold 200 and three multilayered bodies 1, 2 and 3 are shown therein which are mutually superimposed and connected (for example, but not exclusively, by means of screws 101, as shown) to form the manifold 200.

[0057] The manifold 200 further has, therein, a plurality of channels 102 mutually connected to define the aforesaid circulation paths or circuits, said channels being in fluid communication with the exterior by means of at least one inlet and/or outlet connected to the component parts of the machine which are not housed in the manifold 200, for example, to one or more of the tanks and/or filters and/or cartridges and/or pump valves of FIG. 1, the passive components of the machine (sensors or the like) 400 being on the contrary at least in part housed in the manifold 200 according to the methods explained below.

[0058] As shown, the manifold 200 comprises a first outer multilayered body 1, an intermediate multilayered body 2 superimposed on said first outer multilayered body 1 and a second outer multilayered body 3 superimposed on said intermediate multilayered body 2 on a part opposite with respect to said first outer multilayered body 1, said three bodies being mutually rigidly fastened, for example, but not necessarily, by means of screws 101; with regard to the intermediate multilayered body 2, the same may be made of adhesive material to act both as a glue and as a gasket between the outer multilayered bodies 1 and 3. Furthermore, according to alternative embodiments, the intermediate body 2 may be omitted and the bodies 1 and 3 may be mutually fastened by means of different solutions, for example, by means of laser or ultrasound welding.

[0059] In particular, the first outer multilayered body 1 has at least one plurality of first grooves or depressions 102 (only one shown in FIG. 5a) mutually connected to form one or more channels and/or paths and/or circuits for the circulation of liquids, wherein each first groove 102 extends both from the surface 103 of the outer body 1 in contact with the intermediate multilayered body 2 by a depth lower than the whole thickness S thereof, as well as perpendicularly to said thickness, and therefore perpendicularly to the plane of FIG. 6a.

[0060] With reference to the intermediate multilayered body 2, the same has a plurality of second grooves 202 each placed at one said first groove 201 of the first outer multilayered body 1, and wherein each second groove 202 extends both for the entire thickness s of said intermediate multilayered body 2 in a passing-through manner, as well as perpendicularly to said thickness s (to the plane of FIG. 6a), the first 102 and the second grooves 202 thus defining inner circulation channels of said fluids, wherein each said second through groove (202), from the opposite part to said first multilayered body 1, is closed by said second outer multilayered body 3, also called top.

[0061] FIG. 2b shows a top plan view (from above with respect to FIG. 6a) of the first outer multilayered body 1 sectioned at the height of the first grooves 102 (section A-A of FIG. 6a) and clearly shows the first grooves 102 connected to form the aforesaid circulation circuits or paths for fluids or liquids (see the following description). Furthermore, the outer layer 1, at said first grooves 102, and along the path thereof, has one or more wells 104 by means of which the first grooves 102 are placed in fluid communication with the exterior of the manifold. Each said well or hole 104 extends, in fact, between the upper surface 105 of the multilayered body 1 and a respective first groove, wherein, therefore, each well or hole 104 may be used as an inlet and respectively as an outlet for the introduction of liquids into the groove 102 (and therefore in the corresponding circulation channel or circuit) and respectively for the discharge of the liquids from the groove 102 (and therefore from the corresponding channel or circuit). The wells or holes 104 are therefore shaped so as to be connected with component parts of a dialysis machine which are exterior to the manifold (valves, pumps, tanks and the like), wherein, for the purpose, according to an embodiment of the present invention, in each well or hole 104 a flexible connecting tube 106, for example made of silicone, is arranged.

[0062] Furthermore, with reference to FIG. 2b, it is possible to appreciate that the outer multilayered body 1 has a plurality of second wells 107 arranged along the first grooves 102, said second wells 107 each defining a seat for housing respective control and/or monitoring components 12, for example, pressure and/or flow and/or temperature and/or conductivity sensors and/or the like, arranged in the respective housing seats 107 so as to be at least in partial flow interference with the liquid in the underlying groove 102.

[0063] In particular, the second wells 107 may either be dead towards the surface 105 of the multilayered body 1, or open and therefore extend from the respective first groove 102 until surfacing from the surface 105, thereby making the access from the exterior of the manifold to the respective component 12 housed therein possible.

[0064] With reference to FIGS. 1, 2a and 2b, a description will be given below of two liquid circulation circuits defined at least in part by a manifold according to an embodiment of the present invention and therefore obtained therein according to the methods clarified above.

[0065] As shown, the first circuit comprises two sections or sub-circuits, respectively shown in the Figures by means of a dotted line (first sub-circuit) and a broken line (second sub-circuit).

[0066] In the first and second sub-circuits the direction of the flow is that of the arrows.

[0067] By means of the first sub-circuit (dotted line) water is drawn, for example, from a hospital network (point 0) and then conveyed along the first section of the sub circuit, where a pressure sensor, a pressure regulator (FIG. 2a), bringing the network pressure from 2-3 bars to 1 bar, and a two-way valve are inserted.

[0068] The water is then conveyed to point 1 which is the tank, wherein the water level in the tank 408 is kept constant by means of the upstream two-way valve which opens and closes by virtue of the level sensor inside the tank 408.

[0069] From the tank 408 the water is drawn by means of a pump (point 2) and then conveyed along the section downstream of the tank 408 where four conductivity sensors, two control sensors and two protection sensors are present, as well as four pressure sensors and one flow sensor, which are used for control.

[0070] This sub-circuit ends at point 3 where there is a deviation valve.

[0071] Furthermore, in this first sub-circuit, two injection points are present for the bicarbonate and the acid which are used to concentrate the water (point B and point A).

[0072] Finally, the flow continues in point 4, with the suction by means of the second pump, where two pressure sensors and one flow sensor are present, wherein finally the water is discharged (point 5).

[0073] The broken line circuit indicates the deviation of the water at point E1, i.e., wherein, once the relative valve is activated, the water is conveyed towards the patient to go to the filter 409 countercurrent and clean the blood.

[0074] Once passed through the filter 409 (see arrows) the water is again inserted in the central section (point E2) and then discharged in point 5. When this section or sub circuit is activated, the segment of point 6 is not crossed by water.

[0075] With reference to FIGS. 1, 3a and 3b, a description will be given below of two further liquid circulation circuits defined at least in part by a manifold according to an embodiment of the present invention and therefore obtained therein according to the methods clarified above.

[0076] As shown, also the second circuit consists of two sections or sub-circuits, in particular, a first sub-circuit (dotted line) and a second sub-circuit (continuous line). The circuit indicated with the dotted line is part of the system for degassing and heating the water present inside the tank (point 1).

[0077] This circuit, by means of the pump (point P) draws the water in point 2, wherein the water, by means of the pawl and a three-way valve (calibrated restriction of 1 mm in diameter, point 3, with a formation of a local depression which facilitates the escape of air) is conveyed through a pressure sensor (point 4, used for checking the correct flow) and, by means of a solenoid valve (point 5), is reintroduced into the tank 408; in this case it is therefore a continuous cycle (see arrows direction).

[0078] The flow set to have an excellent degassing is of about 2 l/min.

[0079] Inside the tank 408 there is a heating cartridge which keeps the liquid at 37 degrees. The circuit highlighted with a continuous line allows maintaining a constant level inside the bicarbonate cartridge 410 during the treatment, wherein the liquid flows due to load losses.

[0080] With reference to FIGS. 1, 4a and 4b, a description will be given below of a further liquid circulation circuit defined at least in part by a manifold according to an embodiment of the present invention and therefore obtained therein according to the methods clarified above.

[0081] The circuit is composed of two sections, one shown by means of a dotted line and the other by means of a continuous line, which intervene in two distinct steps of the operation of the machine.

[0082] The continuous line circuit serves to hydrate the bicarbonate cartridge 410 (point 1) and to create a supersaturated solution which is then diluted. Hydration consists in drawing water (point 2) from the tank 408, by using the pump P (the same as the one of the degassing circuit), wherein water is introduced into the bicarbonate cartridge 410 by means of the valve (point 3).

[0083] In the case of the circuit section represented by the continuous line, this has the function of emptying the cartridge 410 at the end of the treatment. The suction of the pump (point p) is deviated by the valve (point 4), which draws the water from the inside of the cartridge 410 (point 1), wherein the water drawn is conveyed to the outlet (point 6) through the valve (point 5).

[0084] It has thus been shown, by means of the above detailed description of the embodiments of the present invention depicted in the drawings, that the present invention allows achieving the preset aims and/or to overcome or at least minimize the typical drawbacks of the solutions according to the background art.

[0085] In particular, the present invention allows the making of a dialysis machine or equipment which provides for a reduced and limited use of flexible pipes and therefore eliminates or at least reduces the risk of accidental disconnections thereof, or in any case the risk of leaks along the one or more circuits for liquids of the machine and/or equipment itself.

[0086] Furthermore, the present invention provides a dialysis machine or equipment which defines one or more circuits for the extracorporeal circulation of liquids, each of said circuits being connectable to circuits and/or equipment exterior to the machine (for example, to the drinking water network) according to equally simple and immediate methods, and so as to ensure maximum reliability of the connections, thus eliminating, even in this case, the risk of accidental disconnections and/or leaks.

[0087] Finally, the machine or equipment according to the present invention requires minimal, simple and inexpensive maintenance, ensures constant reliability and a high level of performance over a sufficiently long period of time, as well as the maximum level of hygiene and the minimum risk of infections and/or contamination.

[0088] Although the present invention has been clarified by means of the detailed description of the embodiments thereof depicted in the drawings, the present invention is obviously not limited to the embodiments described above and depicted in the drawings; conversely, all those variants of the embodiments described and depicted, which will be obvious and evident to those skilled in the art, are within the scope of the present invention.

[0089] The object of the present invention is thus defined by the claims.