FR3068611A1 - INFUSION SYSTEM FOR ADMINISTERING A SOLUTION AND RINSING THE SAID SYSTEM - Google Patents

Abstract

The invention relates to an infusion system (1) comprising a bag (2) comprising a first compartment (3) with a first solution and a second compartment (4) with a second solution, said first compartment (3) being provided with an inlet tube (5) and an outlet tube (6), and a connecting device (8) in fluid communication with the first compartment (3) and the second compartment (4), a reversible shutter of flow (9) being interposed in the connecting device (8), said shutter being adapted, as a function of the differential pressure between the upstream and downstream of said shutter, to prevent or allow the flow of the second solution , the inlet tube (5) of the first compartment (3) opening inside said first compartment (3) at a level greater than that to which the outlet tube (6) of the first compartment (3) opens.

Description

The invention relates to an infusion system for infusing a drug solution to a patient.

It typically applies to a gravity infusion intended to allow parenteral administration of a solution for injection to a patient. In a particular embodiment, the solution to be injected contains an active ingredient requiring a precise dosage, such as an antimitotic or antibiotic agent.

Document EP-1 060 754 discloses an infusion system forming a closed and unitary system comprising at least two bags, one containing a medicinal solution and the other a rinsing solution, and infusion means. This perfusion system further comprises selection means with external control able to select the passage through the perfusion means of the solute containing the medicament and / or of the rinsing solute.

However, the use of this system requires the presence of nursing staff during the infusion since this staff must maneuver the selection means with external control. In addition, if the nursing staff does not stop the infusion of the drug solution before the bag containing it is completely empty, the air contained in it can be introduced into the infusion means. In this case, during rinsing, the volume of air is administered to the patient, thereby causing a gas embolism.

Document WO 2017/005265 describes an infusion bag comprising two or more compartments in which the communication between the two compartments is established by manual activation of a button placed on the weld separating the two compartments. However, this pocket has the same drawbacks as those mentioned above.

To resolve these drawbacks, document FR-2 871 062 proposes in particular a bag for medical use for infusion of a drug by gravity, comprising at least two compartments, one containing a drug solution and the other a rinsing solution, and separation / communication means of the compartments allowing the rinsing solution to automatically enter the compartment containing the medicament only at the end of the infusion of the medicament solution. In a particular embodiment, a pressure threshold valve is placed between the two compartments placed one above the other, so that when the bottom compartment containing the drug solution is empty, the rinsing solution included in the top compartment drains.

Another infusion system in which a rinsing solution flows automatically at the end of the infusion of a drug solution is described in document EP-1 722 840. This system consists of a bag comprising a first compartment containing the drug solution and a second compartment containing the rinsing solution. Part of the first compartment is provided above the second compartment and another part at and / or below the second compartment. Tubing containing a duckbill valve connects the first and second compartments, so that, when the first compartment is empty or almost empty, the rinsing solution included in the second compartment flows automatically into the first compartment to rinse it by a dilution effect.

A perfusion system similar to that described in document EP-1 722 840 making it possible to improve the rinsing was proposed in document WO 2014/096643. In this improved infusion system, an extension projecting inwardly from the first compartment containing the drug solution is provided so as to divert the flow of the rinse solution from the second compartment from the direct flow path between the tube d entry and exit of the first compartment.

This improved perfusion system is not yet entirely satisfactory because it sometimes happens that the dropper chamber of the perfusion device which is connected to the perfusion system at its outlet tube, empties before the end of the rinsing, causing the undesirable presence air bubbles in the infusion set.

The invention thus provides an improved infusion system allowing optimal rinsing in order to precisely respect the dosage of drug solution to be infused, while avoiding the presence of air in the infusion device.

To this end, the invention proposes a perfusion system comprising:

- a bag comprising at least a first compartment and a second compartment, said first compartment containing or being intended to contain a first solution, said first compartment being further provided with at least one inlet tube forming an inlet orifice and d an outlet tube forming an outlet orifice, said inlet and outlet tubes being arranged on the same edge of said first compartment and said second compartment being provided with an outlet tube forming an outlet orifice, said second compartment containing or being intended to contain a second solution, and

a connection device putting or intended to put in fluid communication the first compartment at its inlet tube and the second compartment at its outlet tube, a reversible flow shutter being interposed in the connection device, said obturator being able, as a function of the pressure differential between the upstream and downstream of the reversible flow obturator, to prevent the flow of the second solution during the infusion of the contents of the first compartment and to allow the flow of the second solution during the infusion of the contents of the second compartment, the inlet tube of the first compartment opening inside said first compartment at a level higher than that to which the outlet tube of the first compartment opens, so to allow the flow into the first compartment of the second solution before the complete emptying of the contents d u first compartment.

Other objects and advantages will appear during the description which follows.

Figure 1 shows schematically a perfusion system according to a first embodiment of the invention.

Figures 2 to 5 schematically show a partial view of several variants of the infusion system of Figure 1.

FIG. 6 schematically represents a perfusion system according to another embodiment of the invention.

Figure 7 schematically shows the infusion system of Figure 1 connected to an infusion device.

The terms upper, lower, horizontal, vertical, above and below are defined in relation to the normal position of use of the infusion system, i.e. the position of the system at the time when the patient is going to be infused. The terms upstream and downstream are defined in relation to the direction of flow of the solutions in the perfusion system.

The invention relates to a gravity infusion system, in particular intended to allow parenteral administration of injectable solutions to a patient. In particular, the perfusion system allows the administration of a first injectable solution containing an active principle requiring a precise dosage, such as an antimitotic or antibiotic agent, and of a second injectable solution making it possible to at least partially rinse the system. infusion to ensure optimal administration of the first solution for injection.

According to the invention and in relation to FIG. 1, the perfusion system 1 essentially comprises on the one hand a bag 2 comprising at least a first compartment 3 and a second compartment 4, said first compartment 3 containing or being intended to contain a first solution and said second compartment 4 containing or being intended to contain a second solution and on the other hand a connection device 8 putting or intended to put in fluid communication the first compartment 3 and the second compartment 4, a reversible flow shutter 9 being interposed in the connection device 8, said shutter being able, as a function of the pressure differential between the upstream and downstream of the reversible flow shutter, to prevent the flow of the second solution during the infusion of the contents of the first compartment 3 and to allow the flow of the second solution during the infusion contents of the second compartment 4.

When using such an infusion system 1, once most of the first solution contained in the first compartment 3 has been infused to the patient via an infusion device 25 described below, the second solution contained in the second compartment 4 flows into the connection device 8, into the first compartment 3 and then into the perfusion device 25.

This step, called the rinsing step, must in particular make it possible to rinse the perfusion device and in part at least the first compartment, with the second solution in order to eliminate and / or dilute the first solution.

The first and second solutions are injectable solutions. They are introduced, respectively, into the first and second compartments 3, 4 at the time of manufacture of the perfusion system 1 or introduced into the perfusion system 1 at the time of use by an inlet / outlet port for each. of said compartments 3.4.

For example, the first compartment 3 contains a solution comprising a medicament, such as an antibiotic or an antimitotic, and the second compartment 4 contains a rinsing solution. Examples of rinse solutions include sodium chloride, glucose and Ringer's solutions.

In a particular example, the first compartment 3 is intended to contain a volume of first solution, in particular between 25 and 500 ml and the second compartment 4, a volume of second solution, in particular between 25 and 150 ml. More particularly, the first compartment comprises 100 ml of first solution and the second compartment comprises 30 ml of second solution.

For example, the bag 2 is formed by associating between them two flexible sheets along a peripheral seal which forms the edges of the bag 2, in particular having a lower seal 10.

In a variant not shown, the pocket is formed of a flexible sheet folded back on itself along a fold line. The folded parts are assembled along a joint which forms, with the fold line, the edges of the pocket.

According to another variant not shown, the pocket is formed of a flexible sheath, closed by two opposite seals, respectively upper and lower.

The first compartment 3 is further provided with at least one inlet tube 5 forming an inlet orifice and an outlet tube 6 forming an outlet orifice, said inlet 5 and outlet 6 tubes being arranged on a same edge of said first compartment 3 and said second compartment 4 being provided with an outlet tube 7 forming an outlet orifice.

The inlet 5 of the first compartment 3 is intended to allow the introduction into the first compartment 3 of the second solution contained in the second compartment 4.

The outlet orifice 6 of the first compartment 3 is intended to allow the evacuation of the first and the second solution towards the patient to be perfused, via in particular an infusion device described below.

In FIG. 1, the inlet tube 4 and the outlet tube 6 of the first compartment 3 are arranged in the lower seal 10 of said pocket 2 forming the lower edge of the pocket 2.

The outlet port 7 of the second compartment 4 is intended to allow the evacuation of the second solution contained in the second compartment

4.

In FIG. 1, the outlet tube 7 of the second compartment is arranged in the lower seal 10 of said pocket 2, on the same lower edge of the pocket 2 as the inlet tube 5 and the outlet tube 6 of the first compartment 2.

According to FIGS. 1 and 6, to optimize the evacuation of the contents of the first compartment, the portion of the peripheral seal forming the lateral edge of the pocket 2 on the side of the first compartment 3 is inclined outward from the lower seal 10 in which is arranged the outlet tube 6 of the first compartment.

For example, as illustrated in FIG. 6, the angle of inclination a1 of the portion of the peripheral seal forming the lateral edge of the pocket 2 on the side of the first compartment 3 is between 10 and 20 °, in particular 12 °, with respect to the vertical.

The first compartment 3 and the second compartment 4 of the pocket 2 are separated by a compartmentalization joint 11.

In FIG. 1, the compartmentalization joint 11 extends between the lower edge and the lateral edge of the pocket 2 on the side of the second compartment 4, in particular on the peripheral joint. In this configuration, before the solutions are infused, a volume of the first solution in the first compartment 3 is above the volume of the second solution contained in the second compartment 4.

In particular, the compartmentalization joint 11 is inclined relative to the vertical towards the second compartment 4 to optimize the evacuation of the solutions from the first compartment 3.

More particularly, the compartmentalization joint 11 comprises a first inclined portion 12 and a second inclined portion 13, the angle of inclination of the first portion 12 of the compartmentalization joint 11 relative to the vertical being less than that of the second portion 13.

For example, as illustrated in FIG. 6, the angle of inclination a2 of the first portion 12 is between 10 and 20 °, in particular of the order of 12 °. The angle of inclination b of the second portion 13 is between 30 and 40 °, in particular of the order of 35 °.

With this particular partitioning joint 11, the release of the reversible shutter 9 described later is more regular, and the flow of the second solution in the first compartment is more homogeneous thanks to the water column created in the first compartment in end of evacuation of the first solution.

In particular, each of the angles of inclination a1, a2 of the lateral portions of the first compartment 3 of the pocket 2 relative to the vertical is between 10 and 20 °. Advantageously, the angle of inclination a1, a2 is the same for each of the two lateral portions (FIG. 6).

This inclined configuration optimizes the flow of the first and second solution to the outlet tube 6 of the first compartment 3 of the bag.

2. This avoids the blocking of the first solution in the corners of the first compartment 3 of the first pocket 2 when the latter is collapsed.

The peripheral seal and the compartmentalization seal 11 are in particular formed of a weld bead produced by thermal or high frequency welding.

In Figures 1 and 6, the peripheral seal further comprises on the upper edge of the pocket 2 a means for suspending the pocket 2 in the form of an opening (Figure 1) or a slot (Figure 6).

The perfusion system 1 also comprises a connection device 8 putting or intended to put in fluid communication the first compartment 3 at its inlet tube 5 and the second compartment 4 at its outlet tube 7.

According to FIG. 1, the connection device 8 is formed by a connection tube 14 connected at one end to the inlet tube 5 of the first compartment 3 and at the other end to the outlet tube 7 of the second compartment 4 of the pocket 2.

Advantageously, the pocket 2 and the connection device 8 together form a unitary and closed system, that is to say a ready-to-use system whose various elements constituting it are pre-connected. The elements being connected during manufacture, this avoids a connection step prior to the use of the device, which constitutes additional manipulation resulting in a loss of time and a risk of contamination.

A reversible flow shutter 9 is interposed in the connection device 8, said shutter being capable, as a function of the pressure differential between the upstream and downstream of the reversible flow shutter, of preventing flow from the second solution during the infusion of the contents of the first compartment 3 and allowing the flow of the second solution during the infusion of the contents of the second compartment 4.

The reversible flow shutter 9 will allow automatic flow, that is to say without human intervention, of the second solution contained in the second compartment 4 to the first compartment 3, when a major part of the solution contained in the first compartment 3 is discharged from said first compartment 3.

In particular, the reversible shutter 9 is of the non-return valve type which an excess of pressure causes the momentary opening or closing if the pressure is exerted in the opposite direction of the flow of the solution.

A particular example of such a reversible shutter 9 is a valve called duckbill or pressure threshold valve.

The position of the reversible shutter 9 on the connection pipe 14 has no influence on the triggering of said reversible shutter 9. For practical reasons, it is advantageous to position it closest to the second compartment 4.

The operating principle of such an automatic perfusion system is based on the principle of communicating vessels according to which the pressures on either side of the reversible shutter 9 and the levels of the solutions in the first compartment 3 and the second compartment 4 tend to balance automatically.

To avoid triggering the reversible shutter 9 before use of the perfusion system, the connection device 8 comprises a means for controlling the flow of fluids in said connection device, such as one or more clamps and / or a or circuit openers.

In connection with FIG. 1, the connection pipe 14 comprises two circuit openers 15, 16 placed upstream and downstream of the reversible flow shutter 9, respectively.

To allow the fluids to flow into said connection pipe 14, it suffices to break the circuit openers 15, 16 at their zone of weakness.

In an alternative embodiment illustrated in FIG. 6 of the perfusion system, the connection device 8 forms a separate assembly from the bag 2, to be connected to the bag 2 when the perfusion system is used.

According to FIG. 6, the connection device 8 is formed of a connection tube 14 which comprises at each of its ends, connection means 17, 18 to the inlet orifice 5 of the first compartment of the bag 2 and to the outlet 7 of the second compartment 4, respectively. In particular, such a connection means is formed of a perforator.

This connection tube 14 is then connected to the outlet tube 7 of the second compartment and to the inlet tube 5 of the first compartment when the infusion system is used.

In this alternative embodiment, the outlet tube 7 of the second compartment 4 and the inlet tube 5 of the first compartment are each provided at their outer end with a breakable plug 20.21 closing said tubes 5.7.

The breakable stopper 20,21 comprises two stopper parts separated by a frangible part which can be broken by a rotational movement, for example. A pair of fins is arranged on either side of the frangible part to facilitate gripping and opening of the cap by separation of the two cap parts. A sealing membrane is also arranged in the breakable cap, to prevent the flow of fluids when the frangible part is broken. The waterproofing membrane is thin enough to pass through the perforator of an infusion device and allow the flow of fluids.

In this alternative embodiment, the means for controlling the flow in the connection tube 14 is in the form of a clamp 19.

As seen above, the outlet tube 6 of the first compartment is connected or intended to be connected to an infusion device shown in FIG. 7.

In connection with FIG. 1, the outlet tube 6 is extended by an infusion tube 22 closed at its end by a breakable cap 23 as described above.

In addition, the infusion tubing 22 is provided with an injection site 24 which allows the reconstitution of a drug solution before the infusion.

For example, during the manufacture of the infusion system 1, the two compartments 3, 4 are pre-filled with an injectable solution of the rinsing solution type. In particular, the two compartments 3,4 contain the same solution. At the time of use, a medicament is reconstituted in the solution contained in the first compartment 3 using a transfer device via the injection site 24 placed on the infusion set 22.

As illustrated in FIG. 7, the perfusion system 1 further comprises an infusion device 25 in fluid communication with the first compartment 3 via a perfusion tube 22 connected to the outlet tube 6 of the first compartment 3. This perfusion device 25 is intended to be connected to the venous circuit of the patient, either directly or via a catheter in order to administer at least the first solution to said patient. This perfusion device 22 is described in more detail below in relation to FIG. 7.

In FIG. 7, the perfusion device 25 comprises a means of connection 26 to the venous circuit of the patient, such as a needle or a connection for a catheter, in particular a male connection of the Luer cone type.

The infusion device 25 further comprises a dropper chamber 27, which constitutes a means of controlling the flow rate of the infusion. The dropper chamber 27 is connected at one end to the infusion set 22 and at the other end to the connection means 26 by means of a set 28.

This dropper chamber 27 is also suitable for starting the infusion of the first solution, that is to say for sending the solution into the infusion device 25.

A flow regulator 29 with a wheel capable of controlling and stopping the flow of the solution to be perfused is placed on the tube 28 of the perfusion device, in particular downstream of the dropper chamber 27.

In a variant not shown, the perfusion device 25 is connected during manufacture to the bag 2 via the perfusion tubing 22, thus forming a unitary and closed system.

In the infusion system of the invention, it is important to avoid the early initiation of flow into the first compartment of the second solution contained in the second compartment. Indeed, the early opening of the reversible shutter does not allow optimal rinsing of the first compartment.

A late start of the flow in the first compartment of the second solution contained in the second compartment is also to be avoided. In fact, if the reversible flow shutter 9 is triggered too late, it has been observed that the dropper chamber 27 of the perfusion device 25 was empty before the end of the rinsing.

According to the invention, the inlet tube 5 of the first compartment 3 opens into the interior of said first compartment 3 at a level higher than that at which the outlet tube 6 of the first compartment 3 opens, so as to allow flow into the first compartment of the second solution before the contents of the first compartment are completely emptied.

The level at which the inlet tube 5 opens into the first compartment 3 is the horizontal plane passing through the upper end of the inlet tube 5.

The level at which the outlet tube 6 opens into the first compartment 4 is the horizontal plane passing through the upper end of the outlet tube 6.

It was found that, in this configuration, the flow in the first compartment 3 of the second solution contained in the second compartment 4 was triggered when the level of the first solution contained in the first compartment 3 substantially reached the level at which the inlet tube 5 of the first compartment 3.

Thus, it is ensured that the reversible flow shutter 9 always opens before the end of the complete emptying of the first solution.

According to FIG. 1, the inlet tube 5 and the outlet tube 6 of the first compartment are arranged in the lower seal 10 of the bag 2, on the same edge of the bag 2, namely the lower edge of the bag 2 .

In a first configuration shown in Figures 1.6 and 7, the outlet tube 6 of the first compartment 3 opens into the interior volume of the first compartment at the lower seal 10 and the inlet tube 5 protrudes from said lower seal 10 towards the inside of the first compartment 3 to open at a level higher than that at which the outlet tube 6 opens.

The outlet tube 7 of the second compartment is arranged in the same lower seal 10 and opens into the second compartment 4 at which the outlet tube 6 opens into the first compartment 3.

Advantageously, in this first configuration, the lower seal 10 comprises an extension 30 projecting inwards from the first compartment 3, said extension 30 being arranged between the inlet tube 5 and the outlet tube 6 of the first compartment 3.

When using the infusion system 1, when the first compartment 2 is empty, it tends to collapse, trapping solution in localized areas and making the rinsing step difficult or impossible.

The presence of the extension 13 between the inlet 5 and outlet tube 6 prevents the second solution from the second compartment 3 from leaving the first pocket 2 without expelling and / or diluting the first residual solution sufficiently.

The length and the shape of the extension 13 are chosen so that the second solution can rise high enough in the first compartment 3 during rinsing and that the second solution can come out through the outlet tube 6 of the first compartment 3.

Advantageously, the extension 30 is adjacent to the inlet tube 5 and to the outlet tube 6 of the first compartment 3.

Even more advantageously, the inlet tube 5 opens into the interior volume of the first compartment 3 at the top of the extension 30.

In FIGS. 1, 6 and 7, the extension 30 narrows from the lower joint 10, forming a triangle with a rounded apex.

This extension 30 deflects the flow of the second solution from the second compartment 4 of the direct flow path between the inlet tube 5 and the outlet tube 6.

The direct flow path between the inlet tube 5 and the outlet tube 6 of the first compartment 3 of the bag 2 is the flow path that the second solution would normally follow in the first compartment 3 between said inlet tubes 5 and outlet 6 when using the infusion system 1, that is to say when the second solution is to be infused to the patient.

The extension 30 is notably produced at the same time as the rest of the peripheral seal, by welding the sheet or sheets forming the pocket 2.

In another configuration shown in Figures 2 to 5, the lower seal 10 comprises a horizontal portion below the level of which opens the outlet tube 6 and a horizontal portion above the level of which opens the inlet tube 5, said portions lower and upper horizontal of the lower seal 10 being connected together by a portion of seal.

In FIGS. 2 to 4, the lower and upper horizontal portions of the lower seal 10 are connected together by an inclined seal portion.

In FIG. 5, the lower and upper horizontal portions of the lower seal 10 are interconnected by a portion of a curved seal. The curved portion faces inside or outside of compartment 3.

In FIGS. 3 to 5, the horizontal portion of the lower seal 10 into which the inlet tube 5 opens out extends over the compartmentalization seal 11. In this configuration, there is no dead volume between the compartmentalization seal 11 and the inlet tube 5 projecting into the interior volume of the compartment 3, in which the first solution could be retained.

The difference between the level at which the outlet tube 6 opens and the level at which the inlet tube 5 in the first compartment opens is in particular between 0.5 and 1.5 cm, more particularly of the order of 1 cm.

If the inlet tube 5 protrudes too high inside the first compartment 3, the reversible flow shutter 9 is triggered too early, preventing a complete rinsing. If the inlet tube 5 protrudes too low inside the first compartment, the reversible shutter 9 is triggered too late, the dropper chamber of the perfusion device 25 emptying before the end of the rinsing.

In addition, in order to reduce the pressure inside the first compartment 3 of the bag 2 and prevent the late opening of the reversible flow shutter 9, the first compartment 3 contains the lowest possible volume of air. , notably less than or equal to 5 ml of air. Even more particularly, the first compartment 3 does not contain air.

In the various embodiments of the infusion system of the invention, the bags, tubes and tubes are produced in particular from a flexible and sterilizable thermoplastic material such as polyvinyl chloride or a polyolefin.

In relation to FIG. 7, the mode of operation of a perfusion system 1 according to the invention will now be described.

When using the infusion system 1, the infusion device 25 is connected to the bag 2 via the infusion tubing 22.

A first step consists in starting the perfusion by sending the first solution into the perfusion device 25 and by filling, in particular three-quarters, the dropper chamber 27.

The circuit openers 15,16 arranged in the connection device 8 are broken to allow the flow of fluids.

In a first phase shown, corresponding to the start of the infusion, the level of the first solution contained in the first compartment 3 of the bag 2 is above the level of the second solution contained in the second compartment 4, and the pressure in downstream of the reversible shutter 9 is greater than the upstream pressure.

In this first phase, since the pressure downstream of the reversible shutter 9 is greater than that upstream, the reversible shutter 9, placed in the connection pipe 14, is closed. Consequently, the second solution cannot flow into the first compartment 3 nor the first solution into the second compartment 4. Thus, only the first solution flows into the infusion device 25.

During the first phase, the first solution flows alone into the perfusion device 25, creating a depression due not only to the drop in the level of solution but also to the crushing of the first compartment on itself (collab effect) . At a certain point, the pressures on either side of the reversible shutter 9 will balance.

In the perfusion system of the invention, this moment corresponds to the moment when the first solution contained in the first compartment 3 reaches the level at which the inlet tube 5 of the first compartment 3 opens. As this level is higher than that at which the opening the outlet tube 6 of the first compartment, it is ensured that there remains the first solution in the first compartment when the reversible shutter is released. Thus, no volume of air is sent into the perfusion device 25 between the successive administrations of the first and second solutions.

The transition to the second phase is then automatic, no external action being necessary.

In this second phase, the first solution continuing to flow by gravity into the perfusion device 25, the pressure downstream of the reversible shutter 9 is lower than the pressure upstream.

The reversible shutter 9 is then opened. The second solution contained in the second compartment 4 flows freely in the first compartment 3 of the bag 2. The solution contained in the first compartment 3 comprising the first and the second solution flows into the perfusion device 25.

In the particular case where the first solution is a medicinal solution and the second solution is a rinsing solution, this second phase constitutes the rinsing step.

In fact, in this phase, the rinsing solution contained in the second compartment 4 flows into the first compartment 3 containing the drug solution, causing the dilution of the drug solution. The solution which passes into the first compartment 3 then into the perfusion device 25 is then a medicinal solution diluted with the rinsing solution.

At the end of the infusion, the drug solution has undergone a serial dilution in the first compartment 3 so that the amount of drug remaining in solution is minimal, in particular by being less than 1% of the amount initially present in the first compartment 3.

Thus, the infusion system 1 according to the invention allows the automatic and sequential administration of a drug solution and a rinsing solution. The last milliliters of solution passing through the infusion device 25 comprising a negligible quantity of medicament, it can be considered that the rinsing of the first compartment 3 and of the infusion device 25 is complete at the end of the infusion.

No volume of air can be administered to the patient between the infusion of the drug solution and the rinse solution, since the administration of the solutions is carried out sequentially and without interrupting the flow of solution in the infusion device. .

In addition, the transition from the first to the second phase is instantaneous, which makes it possible to avoid stagnation of the drug solution in the infusion system 1 and in the patient's venous approach. This avoids possible absorption of the drug by the materials constituting the perfusion system and by the venous approach of the patient, in particular during the infusion of aggressive molecules.

Finally, since the two solutions are administered sequentially and automatically, the risk of reversing the order of administration of the solutions is eliminated.

In a particular example of implementation of the perfusion system as shown in FIG. 7 in which the two compartments 3,4 are pre-filled with the same injectable solution such as sodium chloride, the following successive steps are carried out:

- connect the perfusion device 25 to the perfusion tubing 22,

- priming the first solution in the perfusion device 25,

- reconstitute the drug solution in the first compartment 3 using the injection site 24, and

- open the two circuit openers 15, 16 of the connection device 8,

- run the first solution into the perfusion device 25.

As an alternative, the step of reconstituting the drug solution is carried out before the step of connecting the perfusion device 25 to the perfusion tube 22.

Claims (15)

1. Infusion system (1) comprising: - a pocket (2) comprising at least a first compartment (3) and a second compartment (4), said first compartment (3) containing or being intended to contain a first solution, said first compartment (3) being further provided with '' at least one inlet tube (5) forming an inlet orifice and an outlet tube (6) forming an outlet orifice, said inlet (5) and outlet (6) tubes being arranged on the same edge of said first compartment (3) and said second compartment (4) being provided with an outlet tube (7) forming an outlet orifice, said second compartment (4) containing or being intended to contain a second solution, and - A connection device (8) putting or intended to put in fluid communication the first compartment (3) at its inlet tube (5) and the second compartment (4) at its outlet tube (7) , a reversible flow shutter (9) being interposed in the connection device (8), said shutter being adapted, as a function of the pressure differential between the upstream and downstream of the reversible flow shutter, to preventing the flow of the second solution during the infusion of the contents of the first compartment (3) and allowing the flow of the second solution during the infusion of the contents of the second compartment (4), said system being characterized in that the inlet tube (5) of the first compartment (3) opens into the interior of said first compartment (3) at a level higher than that to which the outlet tube (6) of the first compartment (3) opens, so as to allow the nut in the first compartment (3) of the second solution before the contents of the first compartment (3) are completely emptied. 2. Infusion system (1) according to claim 1, characterized in that the first compartment (3) and the second compartment (4) of the bag (2) are separated by a compartmentalization joint (11). 3. Infusion system (1) according to claim 2, characterized in that the compartmentalization joint (11) extends between the lower edge and the lateral edge of the bag (2) on the side of the second compartment (3). 4. perfusion system (1) according to one of claims 2 or 3, characterized in that the compartmentalization joint (11) comprises a first inclined portion (12) and a second inclined portion (13), the angle d 'inclination of the first portion (12) of the compartmentalization joint (11) relative to the vertical being less than that of the second portion (13). 5. infusion system (1) according to any one of claims 1 to 4, characterized in that the inlet tube (5) and the outlet tube (6) of the first compartment (3) are arranged in a joint lower (10) of said pocket, the outlet tube (6) of the first compartment (3) opening into the interior volume of the first compartment (30) at said lower seal (10). 6. Infusion system (1) according to claim 5, characterized in that the inlet tube (5) projects from the lower seal (10) towards the inside of the first compartment (3). 7. infusion system (1) according to one of claims 5 or 6, characterized in that the lower seal (10) comprises an extension (30) projecting inwardly of the first compartment (3), said extension being arranged between the inlet tube (5) and the outlet tube (6) of the first compartment (3). 8. infusion system (1) according to claim 7, characterized in that the extension (30) narrows from the lower joint (10), forming a triangle with a rounded apex. 9. perfusion system (1) according to one of claims 7 or 8, characterized in that the inlet tube (5) opens into the interior volume of the first compartment at the top of the extension (30). 10. infusion system (1) according to any one of claims 5 to 9, characterized in that the lower seal (10) comprises a lower horizontal portion at the level of which opens the outlet tube (6) and a horizontal portion upper at the level of which the inlet tube opens (5), said lower and upper horizontal portions of the peripheral seal (10) being connected together by a seal portion. 11. infusion system (1) according to claim 10, characterized in that the first compartment (3) and the second compartment (4) of the bag (2) are separated by a compartmentalization joint (11), and in that that the horizontal portion of the lower seal (10) into which the inlet tube (5) opens out extends over said compartmentalization seal (11). 12. infusion system (1) according to any one of claims 1 to 11, characterized in that the connection device (8) is formed by a connection tube (14) connected at one end to the inlet tube (5) of the first compartment (3) and at the other end to the outlet tube (7) of the second compartment (4) of the pocket (2). 13. perfusion system (1) according to any one of claims 1 to 12, characterized in that the reversible flow shutter (9) is a pressure threshold valve. 14. perfusion system (1) according to any one of claims 1 to 13, characterized in that the bag (2) and the connection device (8) together form a unitary and closed system. 15. perfusion system (1) according to any one of claims 1 to 14, characterized in that it further comprises an infusion device (25) in fluid communication with the first compartment (3) via 'an infusion set (22) connected to the outlet tube (6) of said first compartment (3).