WO2019150058A2

WO2019150058A2 - Dialysis machine and method for using a machine of said type

Info

Publication number: WO2019150058A2
Application number: PCT/FR2019/050247
Authority: WO
Inventors: Eric Vincent
Original assignee: Physidia
Priority date: 2018-02-05
Filing date: 2019-02-04
Publication date: 2019-08-08
Also published as: FR3077494A1; WO2019150058A3; FR3077494B1

Abstract

The invention relates to a dialysis machine for treating a body fluid, e.g. blood or plasma, said machine comprising a dialyzer (100), a dialysate supply system (5) having a dialysate supply line (52) connected to the inlet (401) of the dialysate flow-through zone (14), and a dialysate delivery system (510) which is connected to the supply line (52) and which includes at least one pouch (50) for holding dialysate as well as means for pressurizing the pouch (50). The machine also comprises a connection system (450) with a first branch (451) which can be connected to a first dialysate feeding source (40) and which includes a clamp system (C451) for opening/closing the first branch (451), the connection system (450) also having a second branch (452) which can be connected to a second dialysate feeding source (40') and which includes a clamp system (C452) for opening/closing the second branch. The connection system further has a section (455) which communicates with the first branch (451) and the second branch (452) and which can be connected to the dialysate delivery system (510).

Description

Title: Dialysis machine and method of using such machine

FIELD OF THE INVENTION The present invention relates generally to dialysis machines, in particular for hemodialysis, as well as the use (operation and manipulation) of such machines.

PRIOR ART

In general, hemodialysis consists in purifying the blood of substances present in excess, such as urea, vitamin B12, beta- immunoglobulin, or mineral salts. The removal of these excess substances can be done by osmosis by circulating the blood on one side of the membrane and the dialysate on the other side of the membrane. Thus, the substances present in excess in the blood diffuse through the membrane in the dialysate. It is also possible to extract an aqueous fraction of the blood according to an operation called ultrafiltration. Ultrafiltration results from a phenomenon of convection through the membrane. Under the pressure of the blood compartment above the pressure in the dialysate compartment, an aqueous fraction of the blood is pushed through the membrane, which decreases the blood volume. Blood is made up of water, mineral salts, many substances and cells like red blood cells. Said aqueous fraction of the blood that this convection mechanism makes it possible to pass through the membrane, especially comprises water, mineral salts and molecules of small or medium molecular weight, such as vitamin B12.

Unlike an ultrafiltration operation, it is also possible to introduce a appropriate amount of dialysate in the blood according to an operation called retrofiltration. Generally, the dialysate then serves as both exchange fluid with the blood and substitution fluid directly introduced into the blood circuit of the patient.

Between dialysis sessions, we change the dialyzer filter, we throw the blood access lines that connect the patient to the arterial and venous side dialyzer.

In addition, in many dialysis machines known in the state of the art, it is also necessary at the end of a dialysis session, to carry out cleaning, sterilization and rinsing of the components of the dialysate circuit which have have been in contact with the dialysate, such as pipes (or pipes), and usually pumps and flow meters. The machine described in the international application WO2013050689 has notably simplified the operations required between two dialysis sessions by designing a dialysate circuit in the form of a set whose components in contact with the dialysate are simple and inexpensive , which allows to replace them for each session and thus to ensure the continuity of sterility of the machine from one session to another.

However, even if the components in contact with the dialysate are inexpensive, the cumulative amount of components discarded during dialysis sessions remains important, and it remains desirable to be able to reduce this amount of discarded components without having to sterilize at each session the components of the dialysate circuit that have been in contact with the dialysate.

Also known are documents US2014 / 238912 (A1), US2016263306 (A1), US2017189601 (A1) and US2011 / 186517 dialysis machines and systems according to the state of the art. The object of the present invention is to propose a new dialysis machine and a corresponding new method of use making it possible to overcome all or some of the problems described above. The present invention aims in particular to provide a new dialysis machine, as well as a new method of using such a machine, to reduce the cost of use over several sessions, and while maintaining a risk of contamination of the body fluid to be treated which remains very low.

SUMMARY OF THE INVENTION

For this purpose, the invention relates to a dialysis machine for treating a body fluid, such as blood or plasma, said machine comprising:

a dialyzer comprising an enclosure that includes:

a body fluid passage zone having a body fluid inlet and a body fluid outlet, and

a dialysate passage zone which has a dialysate inlet and a dialysate outlet,

a membrane system between the body fluid passage zone and the dialysate passage zone;

a dialysate supply system comprising:

a dialysate feed line which is connected to the inlet of the dialysate passage zone, and

a dialysate delivery system connected to the delivery line, said delivery system comprising at least one flexible bag, called a ventricle bag, for containing dialysate, and means for pressurizing the ventricle bag,

a dialysate evacuation system comprising a dialysate evacuation line which is connected to the outlet of the dialysate compartment,

characterized in that the machine comprises:

a connection system comprising:

a first conduit, called a first branch, having an end capable of being connected to a first dialysate supply source and a clamping system for opening / closing the first branch;

a second conduit, called a second branch, having an end capable of being connected to a second dialysate supply source and a clamping system for opening / closing the second branch;

a portion, preferably in the form of a third conduit, which communicates with the first branch and the second branch and is connectable to the dialysate delivery system.

Such a design of the machine allows a prolonged use, on to at least two dialysis sessions, of the ventricular bag (s), and in particular of the dialysate cassette of which said bag (s) belong. Thus, the cassette can still be used after a first dialysis session to perform a second dialysis session.

Between the first and second sessions, the operator, who may be the user himself, does not need to access the pocket (s) of the dialysate cassette, and simply changes the usual consumables. that are the dialyzer and the blood lines, and connect a new power source to an unused branch of the connection system.

The machine may also include one or more of the following features taken in any technically permissible combination. According to an advantageous characteristic, the first branch is connected to the first dialysate supply source, the clamp system for opening / closing the first branch being in the open position, while the second branch is not connected to said second dialysate supply source, and the clamp system for opening / closing the second branch being in the closed position.

According to an advantageous characteristic, the second branch is connected to the second dialysate supply source, the clamping system for opening / closing the second branch being in the open position, while the first branch is disconnected from said first source of dialysate supply, and the clamp system for opening / closing the first branch being in the closed position.

According to an advantageous characteristic, the machine comprises an acquisition device making it possible to acquire an identifier of a patient, and in that the machine comprises a control unit configured to authorize and prevent the execution of a new dialysis session. in terms of the identifier of the acquired patient.

According to an advantageous characteristic, the or each ventricle pocket forming part of an assembly, called a cassette, which is insertable and removable from a corresponding housing provided in the machine, and said cassette comprising an identifier,

the machine comprises a communication device making it possible to acquire the identifier of the cassette,

and in that the machine comprises a control unit which is configured to determine the number of dialysis sessions performed with the identified cassette and to allow and prevent the execution of a new dialysis session based on said number.

According to an advantageous characteristic, the machine comprises a control unit configured for:

- determine the time elapsed since the end of a dialysis session; and

- authorize and prevent the execution of a new dialysis session according to the time elapsed since the end of the dialysis session. According to an advantageous characteristic, the or each ventricle pocket forming part of an assembly, called a cassette, which is insertable and removable from a corresponding housing provided in the machine, and said cassette comprising a datum representative of an expiry date,

the machine comprises a communication device configured to acquire said datum representative of the expiry date of the cassette, and in that the machine comprises a control unit configured to allow and prevent the execution of a dialysis session as a function of said datum representative of the expiry date of the cassette. According to an advantageous characteristic, the cassette is equipped with an RFID chip on which is recorded one or more data relating to the cassette read by the machine, such as the identifier of the cassette and the date of expiry of the cassette.

According to an advantageous characteristic, the control unit is configured to, after a dialysis session, update the number of dialysis session (s) performed with the identified cassette, and control the writing in the RFID chip said number updated.

According to an advantageous characteristic of the invention, the control unit is configured to, after a dialysis session, order the writing of the patient's identifier in the RFID chip.

According to an advantageous characteristic, the control unit is configured to, after said dialysis session, control the writing in the RFID chip of a time data for calculating the time elapsed since this dialysis session.

According to an advantageous characteristic, the machine comprising the first power source and / or the second power source, at least one of said power supply sources comprises:

a plurality of pockets, called feeder pockets, and

- A connecting device, called octopus interconnect, which comprises a plurality of conduits for connecting the feeder pockets together.

According to an advantageous characteristic, the machine comprises a connecting pipe having two opposite ends, one configured to be connected to one end of the supply line, in place of the inlet of the dialysate passage zone of the dialyzer. the other configured to be connected to one end of the dialysate evacuation line instead of the exit of the dialysate passage zone of the dialyzer.

The invention also relates to a method of using such a machine characterized in that said method comprises the following steps:

- connection by the user of a power source to the first branch of the connection system which is connected to the dialysate delivery system;

- installation by the user, in a housing in the machine, a device, called a cassette, comprising the or each ventricle pocket;

- user connection of the inlet line to the dialysis inlet of the dialyzer and connection of the discharge line to the exit of the dialysate passage zone of the dialyzer;

- execution by the machine of a first dialysis session including priming, dialysis and restitution sequences;

after the first dialysis session, removal of the machine by the user from consumable elements of the machine, excluding the cassette and the connection system;

-déconnection by the user of the first power source relative to the first branch of the connection system and closure by the user of the first branch using the first clamp system;

- User connection of a second power source to the second branch of the connection system which is connected to the dialysate delivery system;

the cassette having remained in the corresponding housing of the machine, connection by the user of the supply line to the inlet of the dialysate passage zone of a new dialyzer and connection by the user of the dialysis line; evacuation at the outlet of the dialysate passage zone of the new dialyzer;

-execution by the machine of a second dialysis session including priming, dialysis and restitution sequences.

According to an advantageous characteristic, the machine control unit authorizes or not the execution by the machine of each dialysis session, according to an identifier of the user, an identifier of the cassette and as a function of a stored number corresponding to the number of use already made of the cassette.

BRIEF DESCRIPTION OF THE DRAWINGS Other features and advantages of the invention will become apparent from the description which follows, which is purely illustrative and nonlimiting and should be read with reference to the accompanying drawings, in which:

- Figure 1 is a schematic view of a dialysis machine according to one embodiment of the invention, configured for a first dialysis session;

FIG. 2 is a schematic view of a dialysis machine according to one embodiment of the invention, in a standby configuration of the machine between a first dialysis session and a second dialysis session in which the connections of the supply line and the evacuation line, previously connected to the dialyzer, are connected to each other by a connecting duct;

FIG. 3 is a schematic view of a dialysis machine according to one embodiment of the invention, configured for a second dialysis session;

FIG. 4 is a perspective view of a cassette of a dialysis machine according to an embodiment of the invention;

FIG. 5 is a perspective view of the cassette of FIG. 4, of a connection system between the dialysate delivery system and a power source, and of a connection duct intended for standby configuration. of the machine, to connect the connections of the dialysate feed and discharge lines from the cassette;

FIGS. 6 and 7 are schematic views respectively illustrating an ultrafiltration step and a retrofiltration step;

FIG. 8 is a schematic perspective view of a plurality of feeder pouches of a dialysate feed source positioned in a support structure and interconnected by an interconnect octopus. The plurality of pockets is connected by the lowest pocket to a branch of the connection system.

DETAILED DESCRIPTION

The concept of the invention is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the concept of the invention are shown. In the drawings, the size and relative sizes of the elements may be exaggerated for clarity. Similar numbers refer to similar items on all drawings. However, this concept of the invention can be implemented in many different forms and should not be construed as limited to the embodiments set forth herein. Instead, these embodiments are provided so that this description is complete, and communicate the scope of the concept of the invention to those skilled in the art. The following embodiments are discussed, for the sake of simplicity, in connection with the terminology and structure of a dialysis machine.

Reference throughout the specification to "an embodiment" means that a particular feature, structure, or feature described in connection with an embodiment is included in at least one embodiment of the present invention. Thus, the appearance of the phrase "in one embodiment" at various locations throughout the specification does not necessarily refer to the same embodiment. In addition, the particular features, structures, or features may be combined in any suitable manner in one or more embodiments. In particular, the order of the process steps can be changed when it remains technically permissible. With reference to the figures and as recalled above, the invention relates to a dialysis machine and a corresponding method of use for treating a body fluid, such as blood or plasma. By body fluid, we mean a liquid of the type of those present in the human or animal body, such as blood or plasma.

It should be noted that the dialysis machine according to the invention is detailed below in the context where the body fluid to be purified is blood. Blood is made up of water, mineral salts, many substances and cells like red blood cells. Of course, the description of the machine below also applies to a body fluid other than blood. Said machine comprises a dialyzer 100. The dialyzer is still usually called a dialyzer filter. The dialyzer 100 is in the form of an enclosure that includes a body fluid passage zone 12 having a body fluid inlet 201 and a body fluid outlet 202. The enclosure also includes a dialysate passage zone 14 which has a dialysate inlet 401 and a dialysate outlet 402.

The dialysate is a liquid well known to those skilled in the art whose composition is close to physiological saline. The dialysate comprises water of mineral and bacteriologically sufficient quality. This water is added to a concentrate, in the form of a powder of mineral salts or in the form of a liquid concentrate, to produce the required dialysate.

In a preferred aspect, the dialysate used is sterile, pyrogen-free dialysate. The dialysate was sterilized for example in an autoclave. This dialysate is made from purified water and salt.

The dialysate circulation passes through the dialysate compartment 14, generally against the blood flow in the other blood compartment 12. The dialysate generally circulates in an open circuit. It is also possible to provide a partial regeneration loop of clean dialysate from the toxin-laden dialysate. The enclosure also includes a membrane system 3 to allow an exchange of elements (substances, molecules) between the body fluid present in the body fluid passage zone 12 and the dialysate present in the dialysate passage zone 14.

As shown in FIGS. 6 and 7, from a functional point of view, the dialyzer filter may be schematized in the form of an enclosure housing a dialysis membrane 3 which separates the chamber into a blood compartment, corresponding to the zone of passage of the body fluid 12 and a dialysate compartment, corresponding to the dialysate passage zone 14. In the following description, the dialysate passage zone, by the terms "dialysate compartment 14", and the passage zone of the body fluid 12, by the terms "blood compartment 12". The dialysis membrane system 3, semi-permeable, is designed to pass a fraction of the blood volume when the difference between the local pressure in the blood compartment 12 and the local pressure in the dialysate compartment 14 is greater than a value. given. This pressure difference is called transmembrane pressure. In particular, the membrane system is designed in such a way that only the smallest molecules can pass through the holes or pores of the membrane system, namely water, mineral salts and molecules of small to medium molecular weight .

More specifically, the membrane system 3 may comprise a membrane designed such that, when the difference between the pressure exerted on at least a portion of the membrane on the side of the blood compartment 12 and the pressure exerted on said portion of the membrane on the side of the dialysate compartment 14 is greater than a given threshold value, said portion of the membrane passes an aqueous fraction of the blood into the dialysate compartment 14, according to a convective phenomenon called ultrafiltration. Conversely, said membrane 3 is designed such that, when the difference between the pressure, which is exerted on said portion of the membrane 3 on the side of the dialysate compartment 14, and the pressure exerted on said portion of the membrane on the side of the blood compartment 12, is greater than a given threshold value, said portion of the membrane passes the dialysate in the blood compartment 12, according to a phenomenon called retrofiltration.

The difference between the average pressure in the blood compartment and the average pressure in the dialysate compartment is called mean transmembrane pressure. Said average is performed on the surface of the membrane.

The dialysis membrane system can be made in the form of capillary fibers, the blood circulating inside the fibers, the dialysate on the outside.

The blood inlet 201 is intended to be connected by an arterial line L1, to a fistula of the patient, to extract the blood from the body of the patient to be treated. The blood outlet 202 is intended to be connected by a venous line L2 to a vein of the patient to reintroduce blood into the patient's body after treatment. The term "line" means a pipe optionally comprising several branches or portions and through which a liquid can flow. According to a particular aspect, these lines can be linked to one another so that one can not be removed without the other.

In the example illustrated in Figure 1, the arterial line L1 is also provided with a blood pump Psg, and a pressure sensor Pa, also called blood pressure sensor. The venous line L2 comprises a pressure sensor Pv, also called venous pressure sensor, a bubble trap PB, and a DA air detector. Advantageously, the pressure sensor Pv is connected to the bubble trap PB. Preferably, said venous line L2 also comprises an anticoagulant injection system, such as a heparin pump PH.

The average pressure in the blood compartment 12 is due to the pressure of venous return added to the pressure related to the pressure drop in the blood compartment 12 which depends on the viscosity of the blood and its flow. Venous return pressure depends on the needle and vascular access used, as well as patient pressure.

The arterial line L1, the venous line L2 and the blood compartment 12 form the blood circuit of the machine.

Said dialysate compartment 14 has a dialysate inlet 401 and a dialysate outlet 402. The machine also comprises a dialysate delivery system 5 which comprises a dialysate supply line 52 which is connected to the inlet 401 of the compartment dialysate 14, and a dialysate evacuation system 6 which has an evacuation line 62 connected to the outlet 402 of the dialysate compartment 14.

The dialysate delivery system 5, the dialysate compartment 14, and the dialysate evacuation system 6 form the dialysate circuit.

The dialysate supply line 52 is connected to the inlet 401 of the dialysate passage zone 14 by a quick coupling, for example a Hansen type connection. The Hansen type couplings correspond to the NF EN ISO 8637 standard.

The delivery system 5 also comprises a dialysate delivery system 510 connected to the supply line 52. Said dialysate supply system 5 makes it possible to deliver dialysate into the dialysate compartment 14 via the supply line 52.

The delivery system 510 includes at least one flexible bag 50, called the ventricle pocket, for containing dialysate. Said system 510 may comprise several pockets as in the example illustrated in the figures. Preferably, as illustrated in FIGS. 1 to 3, said system for feeding the dialysate 5 comprises an additional ventricle pocket 50 'which is mounted in parallel with the portion of the supply line 52 to which said ventricular bag 50 is connected. In the rest of the description, reference is made to a system 510 comprising several pockets 50, 50 ', but it is understood that this description also applies to the case of a delivery system 510 comprising a single pocket. Each ventricle pocket of the system 510 is intended to contain dialysate and is connected to said supply line 52.

Each ventricle pocket 50, 50 'is housed in a substantially leaktight enclosure 500, 500' which can be pressurized, and possibly in depression. Each ventricle pocket 50, 50 'can thus be pressurized by pressurizing means 70 and possibly under vacuum by a vacuum generator 80.

Said pressurizing means 70 comprise a device for injecting pressurized gas, such as an air compressor or a bottle of compressed gas, capable of injecting pressurized gas into the enclosure 500, 500 'sealed in which houses the ventricle pocket 50, 50 '. Said enclosure has an output whose opening is controllable by a solenoid valve to reduce the pressure in the enclosure.

The application of a pressure on the ventricle pocket 50 or 50 'and the regulation of this applied pressure, by means of the pressure difference measured across the pressure-drop tube 520, makes it possible to maintain for a given time a fixed rate of dialysate in the dialysate compartment in a reliable and accurate manner, and thus to control the retrofiltration operations. The application and regulation of the pressure applied to the ventricle pocket 50 or 50 'also makes it possible, by adjusting the pressure applied to the discharge bag 60 or 60', to maintain for a given time a given average pressure in the dialysate compartment. , and thus to control ultrafiltration operations. Both ventricle bags 50, 50 'are able to be pressurized / depressed independently of one another. As illustrated in FIG. 1, each ventricle pocket 50, 50 'is also provided with a closing / opening downstream member C1, C1' of the supply line which, in the open state, allows the flow of dialysate from the pocket 50, 50 'corresponding to the inlet 401 of the dialysate compartment, under the effect of a pressure applied to said ventricle pocket by the corresponding means 70, and in the closed state, prevents said flow of dialysate. Each closure / opening downstream member C1, C1 'of the supply line is situated between the corresponding pocket 50, 50' and the outlet node NS5 connecting the two pockets 50, 50 '. Each ventricle pocket 50, 50 'is also provided with an upstream closing / opening member C2, C2' which makes it possible to authorize or not the feeding of said ventricle pocket 50, 50 'by the power source 40 or 40 .

Each portion of the dialysate feed line 52 at which an upstream or downstream member C2, C2 'or downstream C1, C1' is located is flexible. Each of said closing / opening members C2, C2 ', C1, C1' is formed by a controllable clamp for firstly clamping the wall of said flexible portion of the supply line 52 from the outside so as to close this portion, and, secondly, to leave open said flexible portion of said supply line 52.

The presence of the two ventricular pockets and the alternative clamping system formed by the C1 to C2 'organs makes it possible to successively and alternately charge the ventricular bags from the supply source 40 or 40' containing the reserve. This makes it possible to continuously supply the dialysate supply line from one of the ventricle bags.

The depression of the enclosure of a ventricle pocket 50 or 50 'using of the vacuum generator 80 allows, in the open state of the opening / closing upstream member C2 or C2 ', and in the closed state of the corresponding opening / closing downstream member C1 or C1', d aspirating the dialysate contained in the power source 40 or 40 'to fill said ventricle pocket 50 or 50' (see Figures 1 and 3).

To control the flow of dialysate in the supply line 52, the control unit 10 controls the opening of the downstream member C1 or C1 'of one of the ventricular bags 50 or 50' and the closure of the corresponding upstream member C2 or C2 '. The use of two parallel-mounted ventricle pouches allows one to be charged while the other is in use.

The dialysate supply line 52 has a passage restriction 520 to create a pressure drop and to regulate the pressure applied to the ventricle pocket 50 or 50 'as a function of the pressure difference measured across said restriction. In particular, said line 52 is provided with means for measuring the pressure difference between the inlet and the outlet of said passage restriction 520. This restriction 520 may be formed at least in part of a calibrated tube of constant section which forms a constriction on a predetermined length. Said passage restriction 520 is located between the pockets 50, 50 'and the inlet 401 of the dialysate compartment 14.

The NS5 connection of the delivery system 510 to said supply line 52 is located upstream of the passage restriction 520.

Said pressurizing means advantageously maintain a pressure on the ventricle pocket 50 or 50 'which is sufficient to cause the flow of the dialysate. The supply line is calibrated so that for a given pressure applied to the ventricle pocket 50 or 50 ', the dialysate flow in said line has a substantially constant value. Such a system consisting of a pressure drop tube and means for measuring the pressure difference across the restriction, in particular allows to determine the flow of dialysate which circulates in said feed line and which enters the compartment dialysate. By virtue of the dialysate flow rate thus measured, the control unit 10 can regulate the pressure applied to the ventricle pocket 50 or 50 'to obtain the desired dialysate flow rate entering the dialysate compartment and accurately and reliably maintain this flow rate at a desired rate. value given for a given time. Said means for measuring the pressure difference across the restriction 520 of the supply line 52 may comprise two pressure-taking orifices formed in the peripheral wall of said line 52, one upstream and the other downstream of said restriction 520. Each pressure tapping port is associated with a pressure sensor 523, 524. Each pressure sensor 523, 524 is arranged with respect to the corresponding pressure tapping port so as to measure the pressure in the supply line 52 at said pressure-taking orifice while being spaced from said orifice so as not to be in contact with the dialysate flowing in the line 52, 62. The pressure sensors 523, 524 can be configured as described in the international application WO2013050689 whose content is incorporated by reference in the present application.

It can be provided that the measurement of pressure in the arterial line L1 and the venous line L2 is carried out in the same way as for the pressure tap at the terminals of the restriction 520. It can thus be provided that the pressure sensor Pa and the sensor pressure Pb are fixed in a part of the frame spaced from a pressure port formed in the corresponding line L1, L2. In a particular aspect, the pressure sensors Pa and Pv measure the pressure in the corresponding line L1, L2 without risk of contamination. The dialysate evacuation system 6 comprises a dialysate evacuation line 62 which is connected to the outlet 402 of the dialysate compartment 14 by a quick coupling, for example a Hansen type connection. Said machine comprises an opening / closing system of the dialysate evacuation line 62. Said opening / closing system allows, in the open state, the circulation in said discharge line 62 of the dialysate present at the outlet of the dialysate compartment 14 to fill one of the discharge pockets 60 or 60 ', and prevents, in the closed state, the circulation in said discharge line 62 of the dialysate present at the outlet of said dialysate compartment 14 so that, for sufficient pressure in the dialysate compartment, said dialysate passes through the membrane 3 in the blood compartment. This opening / closing system is detailed below. Said dialysate evacuation system 6 comprises at least one discharge pocket 60, preferably flexible, having an inlet and an outlet connected to the dialysate evacuation line 62. Said opening / closing system comprises an upstream member of the dialysate evacuation line 62. opening / closing C5 located between the outlet 402 of the dialysate compartment 14 and said discharge pocket 60.

Said dialysate evacuation system 6 comprises at least one other discharge bag 60 'mounted in parallel with said discharge bag 60. Thus, the discharge bag 60 and the discharge bag 60' are located on two branches of the d-line. In other words, starting from the outlet of the dialysate compartment 14, the discharge line 62 separates, upstream of the discharge pockets 60, 60 ', in two parallel branches provided with one of the discharge 60 and the other of the discharge bag 60 '. These two branches are connected to each other downstream of the pockets 60, 60 'and upstream of the section restriction 620 as detailed below.

Said opening / closing system comprises another upstream member opening / closing C5 'located between said other discharge pocket 60' and the input node NE6 connecting the reserve pockets 60, 60 '.

Similarly to the upstream members C5, C5 ', each discharge pocket 60, 60' is provided with a closing / opening downstream member C6, C6 'located between the corresponding discharge pocket 60, 60' and the outlet node. NS6 connecting the discharge pockets 60, 60 '.

Each portion of the dialysate evacuation line 62 at which is located an upstream member C5, C5 'or downstream C6, C6' closing / opening is flexible. Each of said upstream members C5, C5 'or downstream C6, C6' closure / opening of the dialysate evacuation line 62 is formed by a controllable clamp to, firstly, pinch the wall of said portion from the outside flexible of the evacuation line 62 so as to close this portion, and, secondly, to leave open said flexible portion of said evacuation line 62.

Such an assembly of upstream members C5, C5 'and downstream C6, C6' closing / opening associated with the discharge pockets 60, 60 'allows the open state of the upstream member C5, respectively C5', and closed of the downstream member C6, respectively C6 ', filling the discharge bag 60, respectively 60', and, in the closed state of the upstream member C5, respectively C5 ', and open of the downstream member C6, respectively C6 ', emptying said discharge pocket 60, respectively 60'.

In the case where the evacuation system 6 is formed by one or more discharge pockets 60, 60 ', it is considered that the evacuation line 62 is open when the dialysate can flow through said line to fill said one or the other one of said pockets.

The means for evacuating the dialysate and the liquid present in the discharge bag 60 or 60 'can be formed by the gravity if the configuration of the discharge bag lends itself to it and / or by pressurizing means 70, preferably common to those used for pressurizing the ventricle bags 50, 50 '. In the latter case, said or each pocket 60, 60 'is housed in a substantially watertight enclosure 600, 600' able to be pressurized by said pressurizing means 70. Said enclosure has an outlet 601 whose opening is controllable by a solenoid valve to reduce the pressure in the enclosure.

It is also possible for each enclosure 600, 600 'which houses a discharge bag 60, 60' to be connected to a vacuum generator 80. The vacuum generator 80 and / or the pressurizing means 70 make it possible to apply a pressure or depression to the discharge bag 60 or 60 ', so as to adjust the average pressure in the dialysate compartment 14 during an ultrafiltration phase. In this case, the downstream member C6 or C6 'of the discharge bag 60 or 60' which is used to adjust the average pressure in the dialysate compartment 14, is closed while the corresponding upstream member C5 or C5 'is open.

Said vacuum generator 80 may be common for the depression of the speakers of the dialysate supply system 5 and the depression of the enclosures of the evacuation system 6.

Said machine comprises means for determining the amount of dialysate and liquid recovered in the emptying bag 60 or 60 'which empties.

Said means for determining the amount of dialysate and liquid recovered in the discharge bag (s) 60, 60 'comprise a passage restriction 620 formed in the dialysate evacuation line 62 and located downstream of said discharge pockets 60 , 60 ', and means for measuring the pressure difference across said passage restriction 620. Said means for measuring the pressure difference across the restriction 620 of the evacuation line 62 may be similar to those associated with the restriction 520 of the supply line 52.

Thus, said means for measuring the pressure difference across the restriction 620 of the evacuation line 62 may comprise two pressure-taking orifices formed in the peripheral wall of said line 62, one upstream and one Another downstream of said restriction 620. According to one particular aspect, each pressure tapping orifice is associated with a pressure sensor arranged so as to measure the pressure in line 62 at said orifice while being separated from said orifice so as to not be in contact with the dialysate flowing in the line 62. In a manner similar to the means for measuring the pressure difference across the restriction 520, a filter that is permeable to air and impervious to infectious agents and liquids, can be interposed between each pressure sensor 623, 624 and the corresponding pressure port. In particular, each pressure sensor 623, 624 is mounted in a cavity of the machine frame by means of a hollow support piece which is intended to be coupled to the conduit 621, 622 connected to the pressure tapping orifice. corresponding.

The pressure sensors 623, 624 associated with said restriction 620 make it possible to determine the pressure difference across the restriction 620 and thus the flow of dialysate and liquid discharged from the discharge bag 60 or 60 ', which makes it possible to determine by measuring the corresponding flow time, the amount of dialysate and liquid recovered in said discharge pocket 60 or 60 '.

The cassette 9 is a removable cassette relative to the frame of the machine which is intended to be inserted into a housing of said frame. Said cassette 9 it comprises in particular the dialysate lines 52, 62 and the pockets 50, 50 ', 60, 60'.

Said pressure sensors 523, 524, 623, 624 are fixed to the frame of the machine. In the inserted state of the cassette 9 in the machine, the pressure taking ducts are in pneumatic communication with the pressure sensors. Pneumatic communication means that the sensor and the corresponding pressure-taking duct are arranged relative to each other so that the sensor is able to measure the pressure that prevails in said duct, and therefore the pressure that reigns in the line at the level where is formed the corresponding pressure port.

Said machine also comprises a control unit 10, such as a programmable controller.

Said control unit is in the form of an electronic and computer system which comprises for example a microprocessor and a working memory. In a particular aspect, the control unit may be in the form of a programmable controller.

In other words, the described functions and steps can be implemented as a computer program or via hardware components (eg programmable gate networks). In particular, the functions and steps operated by the control unit or its modules can be realized by sets of instructions or computer modules implemented in a processor or controller or can be realized by dedicated electronic components or components of the FPGA or ASIC. It is also possible to combine computer parts and electronic parts. When it is specified that the unit or means or modules of said unit are configured to perform a given operation, it means that the unit comprises computer instructions and the means of execution corresponding ones which make it possible to carry out said operation and / or that the unit comprises corresponding electronic components.

Said control unit also has a data entry interface. It can be provided that said interface allows input of data relating to the patient and / or consumables of the machine.

The control unit comprises ultrafiltration control means and retrofiltration control means. As mentioned above, ultrafiltration is the passage through an at least a portion of the membrane 3 of an aqueous quantity of the body fluid from the blood compartment 12 into the dialysate compartment 14. Conversely, the retrofiltration corresponds at the passage of the dialysate, through at least a portion of the membrane 3, from the dialysate compartment 14 into the blood compartment 12. In other words, the control unit is configured to enable control of the phase execution (s). ) ultrafiltration and retro filtration phase (s) by controlling the opening / closing of the clamp systems and the pressure applied to the pockets 50, 50 'flexible depending on the desired phase.

To carry out a retrofiltration step, said backflush control means are configured to control said opening / closing system C5, C5 'so as to close the evacuation line 62, and, in the closed state of said opening line, 62, control the pressure applied to the ventricle pocket 50 or 50 'to retrofilter a given amount of dialysate.

In particular, to control the closing of the dialysate evacuation line 62 for a retrofiltration step, said retrofiltration control means is configured to control the closing of each of said upstream / closing members C5, C5 . In parallel with this retrofiltration step, the previously filled discharge bag can be emptied by opening the corresponding downstream member C6 or C6 '. To control the opening of the dialysate evacuation line 62 for an ultrafiltration step, said ultrafiltration control means is configured to control the opening of one of said upstream opening / closing members. , for example the member C5, and the closure of the other upstream opening / closing member, for example the member C5 ', so that the dialysate at the outlet of the compartment 14 is recovered by one of the two pockets discharge device, for example the bag 60. Advantageously, the control unit 10 controls in parallel the closure of the downstream closing / opening member C6 associated with the discharge bag 60, the upstream member C5 of which is open, to allow said discharge bag 60 to fill. The control unit also controls the opening of the closing / opening downstream member C6 'associated with the discharge bag 60' whose upstream member C5 'is closed, so as to empty said discharge bag 60' and measure the amount recovered in said pocket. Even if one of the branches of the line 62 is closed, the dialysate that leaves the dialysate compartment 14 can flow in said line 62 by the other branch and fill the corresponding discharge pocket, so that said line 62 is considered as open. Said ultrafiltration control means are also configured for, at the next ultrafiltration step, to control the opening of the other C5 'opening / closing upstream member associated with the discharge bag 60' and closing said Upstream member C5 opening / closing associated with the discharge bag 60. The control unit in parallel controls the closure of the downstream member C6 'closing / opening associated with the discharge bag 60' whose upstream member C5 'is open. Meanwhile, the control unit 10 controls the opening of the downstream member C6 closing / opening associated with the discharge bag 60, the upstream member C5 is closed, so as to empty said pocket and measure the amount recovered in said pocket.

The emptying of a discharge bag can be carried out in masked time during a step of retrofiltration and / or ultrafiltration. By measuring the amount of dialysate and liquid recovered in the discharge bag 60 or 60 ', it is possible to adjust the amount of dialysate to be retrofiltered for a subsequent retrofiltration step and / or to adjust the aqueous amount to be ultrafiltered for next ultrafiltration step.

Ultrafiltration makes it possible to extract an aqueous fraction of the blood as illustrated in FIG. 6. In particular, in the case of a patient whose kidneys no longer function, there is no longer any urine production, and the water from his diet and what he drinks is no longer sufficiently eliminated. This results in an overweight patient that can be dangerous for his health. To eliminate the excess water present in the blood it is thus possible to proceed with the ultrafiltration of the blood.

To increase the efficiency of the blood treatment, the machine is also designed to allow to remove from the blood a fraction of liquid greater than that which corresponds to the excess of water in the blood. In this case, this important extraction must be compensated by re-injecting dialysate into the blood to compensate for the volume of liquid extracted in addition to that which corresponds to the excess water in the blood. These ultrafiltration and retrofiltration steps make it possible to improve the purification of the patient's blood while maintaining its fluid balance.

Thus, it can be expected that, at the beginning of a dialysis session, the control unit 10 determines from the "dry" and actual weight data entered, the quantity of excess aqueous fraction to be removed from the body fluid, called the quantity excess water. The "dry" weight of the patient is the weight of the patient when there is no excess water in his blood. A dialysis session can thus comprise in addition to the priming and restitution phases (explained hereinafter), a dialysis phase comprising a plurality of ultrafiltration steps alternating with retrofiltration steps. An example of operation of the machine during a dialysis session with a plurality of ultrafiltration steps alternating with retrofiltration steps is described in the international application WO2013050689 whose contents are incorporated by reference into the present application. However, it should be noted that the dialysis phase generally comprises an exchange phase between the blood compartment and the dialysate compartment, for example by osmosis, and may not include a phase of retrofiltration and / or phase of ultrafiltration In a dialysis session, the priming phase corresponding to the arrival of blood in the blood compartment of the dialyzer. For this priming phase, the control unit controls the blood pump Psg. The dialysis session also includes, as recalled above, a dialysis phase which corresponds to a phase of exchange between the dialysate and the blood in the dialyzer. For this dialysis phase, the control unit controls the means for pressurizing the bags 50, 50 '. Clamp systems C1, C2; C1 ', C2' and C5, C6; C5 ', C6' closing / opening the supply system 5 and the evacuation system 6. The dialysis session ends with a restitution phase during which the blood in the blood circuit (venous line, line arterial, and patient's blood compartment) is returned to the patient. For this restitution phase, the control unit also controls the blood pump Psg, a bag of physiological saline being connected to the line L1 to allow restitution of the blood without risk of introduction of air.

In the example illustrated in the figures, the dialysis machine is also equipped with conventional components to ensure a reliable and effective treatment of the liquid body to be treated, including a blood leakage detector FS formed in the evacuation line 62. Advantageously, the control unit is configured to calibrate the flowmeters relative to each other. For a better readability of the figures, the connections between the control unit 10 and the various components of the machine, other than the communication system 108, 109, with which said control unit 10 communicates to control and / or recover data, were not represented. These components are in particular the members C1 to C6 ', the solenoid valves, the pressure sensors, the temperature sensors as well as the pressurizing means 70, the vacuum generator 80, the blood pump Psg and the injection system PH, and the DA air detector or FS blood leak.

Each enclosure 500, 500 'is provided with means for heating or preheating the enclosure. Each enclosure 500, 500 ', 600, 600' is also provided with an air vent valve V2, V5, V8, V11 associated with an air filter F1, F2, F3, F4, and a sensor. pressure P7, P8, P9 and P10.

The pressurizing means 70 comprise the following elements: a compressed air tank R1, a pressure sensor P11 of the tank R1, a compressor Pa1, a nonreturn valve for the compressed air Ar1, and an air filter and silent for Si1 compressed air.

The vacuum generator 80 comprises an air vacuum tank R2, a pressure sensor P12 of the tank R2, a vacuum pump Pa2, a non-return valve for the air vacuum Ar2 and an air filter and silencer for the air gap Si 2.

The supply line 52 is also provided with heating means Ch3 dialysate associated with temperature measuring means T1, T2, T3. The evacuation line 62 is provided with temperature measuring means T4, T5 downstream of the pockets 60, 60 '. Advantageously, the venous line L2 also comprises a closing / opening member CV, such as a clamp.

The machine comprises at least one bypass line L10, as well as one or more associated closing / opening members Vbp. By-pass line L10 is used to perform the priming and calibration of the dialysate circuit, and to allow not to inject into the dialyzer defective dialysate, for example because of a temperature problem. Advantageously, the evacuation line of the dialyzer is connected to a collection container or to an Egt sewer system.

As can be seen in FIGS. 1 to 3, 5 and 8, the machine also comprises a connection system 450 between a dialysate supply source and the dialysate delivery system 510, for supplying dialysate to the pockets of the delivery system 510. dialysate. In the example illustrated in the figures, the dialysate feed source used for a first dialysis session is referenced 40 and that, distinct from the power source 40, used for a second dialysis session is referenced 40 '.

The dialysate feed source used for a given dialysis session is preferably one or a plurality of larger volume feeder pouches, for example 5L, than that, for example 150 ml, of said ventricle pocket 50, 50 '.

The connection system 450 comprises a first pipe 451, called the first branch, having an end 453 adapted to be connected by a quick coupling, for example a Luer Lock type connection, to the first dialysate supply source 40, and a C451 clamp system for the opening / closing of the first branch 451. The Luer Lock type connectors correspond to the NF EN ISO 594 standard. The connection system 450 also comprises a second pipe 452, called second branch, having an end 454 adapted to be connected by a quick connector, for example a Luer Lock type connection, to a second dialysate supply source 40 ', and a clamp system C452 for opening / closing the second branch.

In a particular aspect, during a dialysis session, the clamping system C451 or C452 that equips the branch 451 or 452 connected to the power source 40 or 40 'is in the open position to allow the dialysate from said supply source for supplying the delivery system 510, while the one or more other clamp systems are in the closed position of the other one or more branches of the connection system 450 to limit the risk of contamination of the circuit dialysate. The connection system 450 also includes a portion, which communicates with the first leg 451 and the second leg 452, and is connectable to the dialysate delivery system 510.

The connecting portion of the delivery system 510 is preferably devoid of an opening / closing clamp system.

The pipes of the connection system are preferably in the form of flexible hoses in order to be clamped. In the example illustrated in the figures, said part of the connection system at which the branches 451 and 452 meet is in the form of a third pipe 455. The third pipe 455 has an end 456 configured to be connected to the entry 511 of the delivery system 510.

Each branch 451, 452 can thus communicate, when it is not pinched, with the pipe 455 which is intended to be connected, by its end 456, at the supply inlet 510 of the dialysate delivery system 510. Supply entry 511 may correspond to the connecting node between pocket entrances 50, 50 '. Alternatively, it could be provided that this portion 455 of the connection system is directly in the form of a connector to be connected to the inlet 511 of the delivery system 510.

According to one embodiment, the connection system 450 is in the form of a Y-shaped tubing, one branch of which makes it possible to connect to the power source 40 at the first dialysis session and then to the power source 40 ' at the second dialysis session. It is understood that the connecting device 450 may have a greater number of branches.

As detailed below, for a given dialysis session, only one branch is connected to a 40 or 40 'dialysate power source, the other branch remaining disconnected either because it has already been used for a certain period of time. previous sitting either because it is intended to be used for a possible future meeting.

It is understood that the use of these branches, that is to say their connection to the dialysate feed sources 40, 40 ', is made selectively according to the sessions, and not simultaneously during of the same session. It is also understood that the pockets 50, 50 'are supplied by means of the dialysate supply source 40 or 40' which is outside the enclosures.

According to a particular aspect and as illustrated in FIG. 8, each power source 40 or 40 'comprises a plurality of pockets 41, called feeder pockets, and a connection device 49, called an interconnect octopus, which comprises a plurality of conducts allowing connect the feeder pockets together at tips 411, preferably using quick couplings, for example Luer Lock fittings. In particular, each dialysate supply source 40 or 40 'can be housed in a support structure 140 with stages of a device as described in the international application WO2014001680 whose contents are incorporated by reference into the present application. Thus, as illustrated in FIG. 8, each feeder pocket 41 of the power source is positioned in a stage of the support structure 140.

According to a particular embodiment, the machine is provided with a system allowing, between two sessions, when the feed lines 52 and evacuation 62 are disconnected from the dialyzer filter 100, to limit the risk of contamination at the ends. 5401 and 6402 of these lines vis-à-vis. It can thus be provided that the system comprises closure elements of these ends or, as illustrated in the figures, a connecting element between these two ends. Such a system makes it possible to limit the risk of contamination / bacteriological proliferation, during a period of stopping the use of the machine (or put on standby) between a first session and a second dialysis session following this standby.

Thus, as illustrated in FIG. 5, a preferably flexible connection duct 700 may be provided having two opposite ends 701, 702. These ends are provided with quick couplings complementary to the quick connectors, for example of the Hansen type, equipping the ends. supply lines 52, and evacuation lines 62. One 701 of the ends of the connecting duct is configured to be connected to the end 5401 of the supply line 52, in place of the inlet 401 of the the dialysate passage zone 14 of the dialyzer 100. The other end 702 is configured to be connected to the end 6402 of the dialysate discharge line 62 instead of the outlet 402 of the dialysate passage zone 14 of the dialyzer 100. The branch 451 or 452 of the connection system 450 it can thus be connected, via a Luer Lock fitting, to a tip 414 of the feeder bag 41 at the lowest position in the positioned position of the feeder pockets in the support structure 140. As mentioned above, the or each flexible ventricle bag 50 , 50 'is part of a set, called cassette 9. Said cassette 9 comprises in particular said pockets, a body 900, and the supply line. According to one particular aspect, the cassette 9 also comprises the dialysate evacuation line 62, and the discharge bag or pockets 60, 60 of the evacuation system. An example cassette 9 is thus illustrated in FIG. 4 in the state not connected to the connection system 450 and in FIG. 5 in the state connected to the connection system 450.

Such combined use of the multi-branch connection system 450 and the flexible pouch dialysate delivery system 510 avoids the need to open the speakers 500, 500 ', and thus to access the cassette, not only during a dialysis session, but also between two successive sessions as long as there remains a branch not yet used of the connection system. Indeed, during a session with the power source 40 and during the next session with the power source 40 ', the cassette and therefore the ventricles pockets can be left in the machine without having to be replaced . The power source 40 is removed and the power source 40 is connected to an unused branch of the connection system 450.

The machine further comprises, as explained hereinafter, a communication system 108, 109, connected to the control unit 10, which enables acquiring data relating to the user patient of the machine and to the cassette 9 (presented below) intended to be introduced into the corresponding housing of the machine, the lines of supply and discharge of dialysate are connected to the dialyzer filter. The communication system comprises for example a reader 108 for acquiring the patient identifier contained in a medium, such as a badge.

The communication system also comprises an RFID device 109 making it possible to read and / or write data in the memory of an RFID chip 90 associated with the cassette 9. The memory of the RFID chip initially comprises an identifier corresponding to the identifier of the cassette, and preferably other data, such as an expiry date and a batch number to which the cassette belongs 9. After a dialysis session, it can be provided as explained hereinafter that additional data related to said session are written on the memory of said RFID chip 90.

The communication system 108, 109 thus makes it possible to acquire the patient identifier and the identifier of the cassette 9.

The control unit 10 to which the communication system 108, 109 is connected is configured to determine whether the identifier of the acquired cassette is already associated with a patient identifier. In the negative, especially when the cassette 9 has not yet been used, the control unit 10 associates in a memory of the machine the patient's identifier and the identifier of the cassette 9 acquired. The control unit 10 also associates with the identifier of the cassette 9 acquired, the number of use of this cassette already made which is initially zero. The control unit 10 is configured to, after each execution of a dialysis session, increment this number of use and prevent the execution of an additional dialysis session with this same cassette 9 when the value of the number of use is greater than or equal to a predefined threshold value, for example two. Thus, according to a particular aspect, at the end of a dialysis session, the control unit 10 increments the number of use to update it and writes, via the RFID device 109, into the memory of the RFID chip 90 of the cassette 9, data comprising the identifier of the patient associated with the identifier of the cassette and the number of use made of the cassette. Thus, particularly in the case of withdrawal and reintroduction of the cassette, the control unit 10 can using the RFID device retrieve the data contained in the memory of the RFID chip. In addition, it can be expected that, at the end of a dialysis session, the control unit 10 writes via the RFID device 109 into the memory of the RFID chip a time reference datum making it possible to calculate the time elapsed since the last session, when the user wishes to perform a new dialysis session.

If the control unit 10 determines that the identifier of the acquired cassette is already associated with a patient identifier, two cases may occur.

According to a first case, the patient identifier already associated with the cassette 9 is different from the acquired patient identifier. In this case, in particular to avoid the risk of cross-contamination, the control unit 10 prevents the execution of a dialysis session for this patient with this cassette 9.

In a second case, the patient identifier already associated with the cassette 9 corresponds to the acquired patient identifier. In this case, the control unit 10 passes, if necessary, the verification of one or more other conditions, before authorizing the launch of the dialysis session. In particular, the control unit verifies the number of uses of the cassette already made. When this determined number is greater than or equal to a threshold value, the control unit prevents the execution of a dialysis session with this cassette.

Other conditions may include checking the elapsed time since the last dialysis session with this cassette. In particular, if this elapsed time is greater than a threshold value, the control unit prevents the execution of a dialysis session with this cassette. Other conditions may include checking the expiry date of the cassette. If this expiry date of the cassette is exceeded compared to the date of the day of use of the machine, the control unit prevents the execution of a dialysis session with this cassette. Other conditions can also be added. When at least one of the dialysis session start conditions is not met, the patient must then change the cassette.

According to one embodiment, the implementation of a dialysis session with a dialysis machine as described above comprises the following steps. As recalled above, where this is technically permissible, the order of certain steps may be reversed and the method may comprise between two further described steps. The method described below allows the prolonged use of a cassette after the completion of a first dialysis session for the execution of a second dialysis session with the same cassette.

Before the connection system 450 is connected to the delivery system 510 and to a dialysate power source 40, the clamping systems C451, C452 are in the open position, so that the lines 451, 452 are not connected. not pinched. Preferably, the user begins by closing the two gripper systems C451, C452.

The user sets up dialysate feeder pockets 41 of the supply source 40 in the support structure 140. The user connects the feeder pockets 41 to each other by means of the interconnect octopus 49. The user installs and connects a saline bag on line L1 upstream of the pump Psg.

The user connects the L2 and L1 arterial lines of the extracorporeal circuit to the dialyzer 100.

For a first dialysis session, the user connects the conduit 455 of the connection system to the delivery system 5410 and connects the branch 451 to the lower pocket 41 of the power source 40 'pocket The user then opens the clamp system C451 to allow the dialysate of the power source 40 to supply the delivery system 510 through the branch 451 and the conduit 455.

Thus, the first branch 451 is connected to the first dialysate supply source 40, the clamp system C451 being in the open position, while the second branch 452 is not connected to said second dialysate supply source. 40. The clamping system C452 for opening / closing the second branch 452 remains in the closed position.

The user opens a door of the machine for introducing into a corresponding slot a cassette 9. The user connects the supply line 52 to the inlet 401 of the dialysate passage zone 14 of the dialyzer 100 and connects the line evacuation 62 at the outlet 402 of the dialysate passage zone 14 of the dialyzer 100.

The user turns on the machine to start the machine. The control unit acquires, for example, by input into a data interface and / or by reading in a data memory relating to the consumables or their batch, such as data identifying the dialysate supply source, the dialyzer, extracorporeal circuit, and cassette. The user can make settings using the input interface, in particular by entering the "dry" and actual weight data to allow the control unit to determine the amount of excess aqueous fraction to be removed from the system. body fluid.

When the conditions for performing a dialysis session are fulfilled, as explained above, the control unit can control the execution of a first dialysis session including priming, dialysis and restitution sequences. . The priming sequence may be preceded by a rinsing step of the consumables by circulating dialysate in the dialysate circuit, particularly in the cassette. In parallel, physiological saline is circulated in the extracorporeal circuit (lines of blood and blood compartment) to rinse this extracorporeal circuit. The patient can then connect to line L1.

At the end of the first session, the control unit controls the purging of the dialysate present in the supply system 5 and the evacuation system 6. The machine can then be put into standby potentially so as to intermittently.

After the first dialysis session, the user removes the consumable elements of the machine, excluding the cassette 9 and the connection system 450, such as arterial lines L1 and venous L2; and the dialyzer. In particular, the user disconnects the connection 5401 from the supply line 52 and the connection 6402 of the evacuation line 62 relative to the dialyzer 100. The saline bag is also removed. Cassette 9 remains in the corresponding housing of the machine. The user also disconnects the first power source 40 with respect to the first branch 451 of the connection system 450 and closes the first branch 451 with the first clamping system C451. For the implementation of a second dialysis session, the second branch 452 of the connection system 450 is connected to the second dialysate supply source 40 '. As for the power source 40, the feeder pockets of the power source 40 'are connected to each other by means of an interconnect octopus. The user opens the clamping system C452 for opening / closing the second branch 452 in the open position.

New L2 'and arterial L1' venous lines are connected to a new dialyzer 100 '. The user installs and connects a new bag of saline.

With the cassette 9 remaining in the corresponding housing of the machine, the supply line 52 is connected to the inlet 401 of the dialysate passage zone 14 of a new dialyzer 100 'and the evacuation line 62 is connected. at the outlet 402 of the dialysate passage zone 14 of the new dialyzer 100 '.

As for the first session, the user can enter parameters using the input interface for the second dialysis session.

When the conditions for performing a new dialysis session are fulfilled, as explained above, the control unit 10 can control the execution of a second dialysis session comprising priming, dialysis and of restitution.

After the first session, it is possible for the user to connect the ends 701, 702 of the connecting duct 700 to the connection 5401 of the line 52 and the fitting 6402 of the evacuation line 62 waiting for a second dialysis session. It can then be provided that the control unit 10 is configured, between the two dialysis sessions, to control the dialysate circulation, preferably periodically, between the supply system 5 and the evacuation system 6 through the connecting pipe 700.

Subsequently, for the second dialysis session, the cassette 9 remained in the corresponding housing of the machine, the connecting conduit 700 can be disconnected from the supply line 52 and the evacuation line. 62 to reconnect the connection 5401 of the supply line 52 and the connection 6402 of the discharge line 60 to the new dialyzer 100 '.

The invention is not limited to the embodiments illustrated in the drawings. Moreover, the term "including" does not exclude other elements or steps. In addition, features or steps that have been described with reference to one of the embodiments set forth above may also be used in combination with other features or steps of other embodiments set forth above.

Claims

A dialysis machine for treating a body fluid, such as blood or plasma, said machine comprising:

a dialyzer (100) comprising an enclosure that includes:

- a body fluid passage zone (12) having a body fluid inlet (201) and a body fluid outlet (202), and

a dialysate passage zone (14) which has a dialysate inlet (401) and a dialysate outlet (402),

- a membrane system (3) between the body fluid passage zone and the dialysate passage zone (14);

a dialysate supply system (5) comprising:

a dialysate feed line (52) which is connected to the inlet (401) of the dialysate passage zone (14), and

a dialysate delivery system (510) connected to the delivery line (52), said delivery system (510) comprising at least one flexible bag (50), called a ventricle bag, for containing dialysate, and means for pressurizing the ventricle pocket (50),

a dialysate evacuation system (6) comprising a dialysate drain line (62) which is connected to the outlet (402) of the dialysate compartment (14),

characterized in that the machine comprises:

a connection system (450) comprising:

a first conduit (451), called a first branch, having an end (453) connectable to a first dialysate supply source (40), and a clamp system (C451) for opening / closing of the first branch (451);

a second pipe (452), called a second branch, having an end (454) capable of being connected to a second dialysate supply source (40 '), and a clamping system (C452) for opening / closing the second branch; a part, preferably in the form of a third pipe (455), which communicates with the first leg (451) and the second leg (452) and which can be connected to the delivery system (510) of dialysate.

2. Machine according to claim 1, characterized in that, the first branch (451) is connected to the first supply source (40) in dialysate, the system (C451) clamp for opening / closing the first limb (451) being in the open position, while the second limb (452) is not connected to said second dialysate supply source (40 '), and the pliers system (C452) for opening / closing the second branch (452) being in the closed position.

3. Machine according to claim 1, characterized in that the second branch (452) is connected to the second dialysate supply source

(40 '), the gripper system (C452) for opening / closing the second limb (452) being in the open position, while the first limb (451) is disconnected from said first feed source. dialysat (40), and the clamp system (C451) for opening / closing the first limb (451) being in the closed position.

4. Machine according to one of the preceding claims, characterized in that the machine comprises an acquisition device (108) for acquiring an identifier of a patient, and in that the machine comprises a control unit (10). ) configured to allow and prevent the execution of a new dialysis session based on the identifier of the acquired patient.

5. Machine according to one of the preceding claims, characterized in that said machine comprising a set, called cassette (9), which includes the or each ventricle pocket (50, 50 '), said cassette (9) being insertable and removable from a corresponding housing formed in the machine, and said cassette (9) comprising an identifier, the machine comprises a communication device (109) for acquiring the identifier of the cassette (9),

and in that the machine comprises a control unit (10) which is configured to determine the number of dialysis sessions (s) performed with the identified cassette (9) and to allow and prevent the execution of a dialysis session according to the number.

Machine according to one of the preceding claims, characterized in that the machine comprises a control unit (10) configured for:

- determine the time elapsed since the end of a dialysis session; and

- authorize and prevent the execution of a new dialysis session according to the time elapsed since the end of the dialysis session.

7. Machine according to one of the preceding claims, characterized in that said machine comprising a set, called cassette (9), which includes the or each ventricle pocket (50, 50 '), said cassette (9) being insertable and removable from a corresponding housing formed in the machine, and said cassette (9) comprising a datum representative of an expiry date,

the machine comprises a communication device (109) configured to acquire said data representative of the expiry date of the cassette (9), and in that the machine comprises a control unit (10) configured to allow and prevent execution a dialysis session according to said data representative of the expiry date of the cassette (9).

8. Machine according to one of the preceding claims, characterized in that the cassette is equipped with an RFID chip (90) on which are recorded one or more data relating to the cassette (9) read by the machine, such as the cassette ID and the expiry date of the cassette.

9. Machine according to claim 8, taken in combination of claim 5, characterized in that the control unit (10) is configured for, after a dialysis session, update the number of dialysis session (s) performed with the identified cassette (9), and order the writing in the RFID chip (90) of said updated number.

10. Machine according to one of the preceding claims, taken in combination of claims 8 and 4, characterized in that the control unit (10) is configured to after a dialysis session, order the writing of the identifier of the patient in the RFID chip.

11. Machine according to one of the preceding claims, taken in combination of claims 8 and 4, characterized in that the control unit (10) is configured for, after said dialysis session, ordering the writing in the RFID chip a time data for calculating the time elapsed since this dialysis session.

12. Machine according to one of the preceding claims, characterized in that, the machine comprising the first power source (40) and / or the second power source (40 '), at least one of said sources of power. diet includes:

a plurality of pockets (41), called feeder pockets, and

- A connecting device (49), called interconnect octopus, which comprises a plurality of conduits for connecting the feeder pockets together.

Machine according to one of the preceding claims, characterized in that the machine comprises a connection duct (700) having two opposite ends (701, 702),

one configured to be connected to one end (5401) of the supply line (52) in place of the inlet (401) of the dialysate passage area (14) of the dialyzer (100),

the other configured to be connected to an end (6402) of the dialysate discharge line (62) in place of the exit (402) from the dialysate (14) passage of the dialyzer (100).

14. A method of using a machine according to one of the preceding claims,

characterized in that said method comprises the following steps:

- connecting a power source (40) to the first branch (451) of the connection system (450) which is connected to the dialysate delivery system (510);

- Installation in a housing in the machine, a device, called cassette (9), comprising the or each ventricle pocket (50, 50 ');

- connection of the supply line (52) to the inlet (401) of the dialysate passage zone (14) of the dialyzer (100) and connection of the evacuation line (62) to the outlet (402) the dialysate passage zone (14) of the dialyzer (100);

after the first dialysis session, removing the machine from consumable elements of the machine, excluding the cassette (9) and the connection system (450);

-disconnecting the first power source (40) from the first leg (451) of the connecting system (450) and closing the first leg (451) with the first clamping system (C451);

- connecting a second power source (40 ') to the second branch (452) of the connection system (450) which is connected to the dialysate delivery system (510);

the cassette (9) having remained in the corresponding housing of the machine, connection of the supply line (52) to the inlet (401) of the dialysate passage zone (14) of a new dialyzer (100 and) connecting the evacuation line (62) to the outlet (402) of the dialysate passage zone (14) of the new dialyzer (100 ');

15. Method according to the preceding claim, characterized in that, the control unit (10) of the machine allows or not the execution by the machine of each dialysis session, according to an identifier of the user, an identifier of the cassette (9) and according to a stored number corresponding to the number of uses already made of the cassette (9).