An interface device located between an external device and a tube intended to be connected to the patient's system

Abstract

An interface device (1) located between an external device (2) and at least one intravenous tube (X1) for transferring fluid to a patient, the device comprising at least: a first port (Pm1) designed to be connected to an outlet port (M1) of the external device (2); a venous port (Px1) carried by a stator of the interface device and used for injecting fluid into the intravenous tube (X1); the interface device (1) having a third port (PB1x), the first port (Pm1) and the third port (PB1x) being carried by a component (1a) movable relative to the stator (1b), the interface device being designed to move from one configuration thereof to another configuration thereof by movement of the movable component (1a) relative to the stator.

Description

Technical Field

[0001] The invention relates to the field of interface devices between a first external device, such as a hemodialysis machine, a nutritional fluid supply or a drug fluid supply, and a second at least one tube connected to a patient system, such as a circulatory system or a digestive system. Background Art

[0002] Certain pathologies require the injection of fluids into the patient's system.

[0003] Implantation of the tube(s) for injection is traumatic for the patient.

[0004] Therefore, when a series of injections is required over a period of days, weeks or months, it is preferable to have the tube(s) connected to the patient's system so that they can be reused for multiple consecutive injections.

[0005] The connection between the external device and the patient is then achieved via at least one venous line and an interface device, which serves as a connector between the external device and the tubing leading into the patient's system.

[0006] Between injections, the tube(s) still implanted in the patient need to be maintained in an environment that limits the risk of any pathogenic factors developing.

[0007] To do this, a locking fluid is injected into each tube after the injection is complete.

[0008] The locking fluid is used to avoid clogging of the tube(s) leading into the patient's system and avoid the need to replace the tube or catheter.

[0009] The details of hemodialysis are described below.

[0010] Hemodialysis involves passing a patient's blood into an external device, such as a hemodialysis machine, and then returning the blood to the patient's circulatory system after it has been processed by the hemodialysis machine.

[0011] To provide a connection between the dialysis machine and the patient's circulatory system, medical personnel connect a first tube to the hemodialysis machine and flow a liquid in the first tube to remove gas therefrom.

[0012] Once the first catheter has been purged of its gases, it is mechanically connected via an interface device to the at least one tube / catheter previously implanted in the patient (each tube / catheter opens into the patient's circulatory system).

[0013] Blood can then be pumped into the hemodialysis machine.

[0014] At the end of the hemodialysis session, the catheter attached to the patient is disconnected from the machine and physiological serum is injected into it to return the blood in the catheter to the patient's circulatory system and flush the tubing.

[0015] Finally, each of the at least one tube is connected to a locking fluid injection device, and the locking fluid is injected into each tube / catheter.

[0016] Between hemodialysis sessions, the presence of a lock fluid in each tube / catheter serves to limit any risk of pathogens / infection developing via the tube.

[0017] When a new hemodialysis session is required, the locking fluid is removed.

[0018] All of these manual manipulations are repeated each time a patient needs to be connected to a hemodialysis machine via a catheter. Consequently, when both a venous and an arterial catheter are implanted to both bring blood into and withdraw blood from the patient, even more manual manipulation is required. This leads to an increased risk of contamination of the patient's circulatory system.

[0019] Patent document US Pat. No. 5,713,850 A describes an interface device for performing hemodialysis.

[0020] The device is used to exchange fluids with a patient via a single tube attached to the patient.

[0021] Therefore, for injecting nutritional fluids into the patient's system (digestive system or circulatory system, as the case may be) and injecting medicinal fluids or dialysis fluids into the circulatory system, it would be useful to develop an interface device that minimizes the risk of contaminating the patient's system. Summary of the Invention

[0022] An object of the present invention is to provide an interface device between an external device and at least one intravenous line, which interface device completely or partially solves the above-mentioned drawbacks of the prior art.

[0023] To this end, the present invention provides an interface device located between an external device and at least one intravenous line for connection to a patient system in order to transfer a fluid from the device to the patient system, the interface device comprising at least:

[0024] a first port adapted to connect to an outlet port of an external device; and

[0025] an intravenous port, which is used to inject fluids into the intravenous line;

[0026] The interface device is adapted to selectively adopt a first configuration in which fluid is prevented from traveling between the first port and the venous port, and a second configuration in which the first port is connected to the venous port to allow fluid to travel from the first port to the venous port.

[0027] The main features of the interface device of the present invention are:

[0028] First, it includes a third port and is adapted to selectively adopt a venous lock access configuration different from the first and second configurations, in which the third port is connected to the venous port while the first port is isolated from the venous port; and

[0029] Secondly, the venous port is carried by the stator of the interface device, and the first port and the third port are carried by a movable component of the interface device that is movable relative to the stator, and the interface device is arranged to pass from any one of its configurations to its other configuration by movement of the movable component relative to the stator.

[0030] Having at least a first port and a third port carried by a movable component of the device (the movable component is preferably a rotor) and having at least one venous port carried by a stator of the device for facilitating use of an interface device:

[0031] Because firstly, the ports for connection to external devices are carried by the movable assembly which holds them together, whereas at least the venous port for connection to a patient via an venous line is carried by the stator; and

[0032] Because secondly, it is the movement of the movable assembly relative to the stator that acts to cause the interface device to travel from any selectable configuration thereof to another selectable configuration.

[0033] By using the interface device of the present invention, it is no longer necessary to continuously perform the following operations:

[0034] manually connecting a locking liquid aspiration port forming part of the external device to the intravenous line (in order to aspirate the locking liquid contained in the intravenous line); and then

[0035] Manually disconnecting the aspiration port enables manual connection of the intravenous line to the outlet port of the external device (in order to inject fluid from the external device into the intravenous line); and then

[0036] This outlet port of the external device is manually disconnected so that the intravenous line can be manually connected to the port for injecting the locking liquid into the intravenous line.

[0037] By reducing the number of manual operations required to connect and disconnect the IV line to the port, the risk of processing errors is significantly reduced, while also reducing the associated risk of contamination to the patient.

[0038] The interface device of the present invention can be used for:

[0039] forming an interface between an intravenous line, which is subsequently passed into the patient's circulatory or digestive system, and an external device for supplying a nutritional fluid, for infusing a nutritional fluid solution therein; or

[0040] forming an interface between an intravenous line and an external device supplying a nutritional fluid, the intravenous line then leading to the patient's circulatory system or digestive system for infusion of a nutritional fluid solution therein; or

[0041] An interface is formed between a venous line and external equipment including a hemodialysis machine, which then leads to the patient's circulatory system in order to exchange blood between the hemodialysis machine and the patient's circulatory system.

[0042] In a specific embodiment, the interface device of the present invention also includes a second port, which is preferably suitable for connecting to an inlet port of an external device (specifically, when the external device is a hemodialysis machine, connected to the inlet port of the hemodialysis machine), and the second port is carried by the movable component of the interface device, and wherein, in the venous lock access structure, the first port and the second port (Pm2) are both isolated from the venous port.

[0043] In a particular embodiment of the interface device of the invention, the movable component is a rotor mounted for rotation relative to said stator.

[0044] By mounting the movable assembly for rotation relative to the stator, an operating gap between the functional surfaces of the rotor and the stator is readily determined to provide a seal while allowing the rotor and stator to move relative to each other.

[0045] The movable assembly may also have a face visible from an exterior side of the interface device, with each port carried by the movable assembly opening in the face.

[0046] Since the ports of the removable components are grouped together and accessible from a single face, this facilitates connecting them with ports of external devices.

[0047] Preferably, the face of the movable assembly and the port carried by the movable assembly are located entirely inside the groove of the stator.

[0048] This face and the ports of the movable assembly are thus protected in the grooves of the stator.

[0049] Preferably, the ports carried by the movable assembly are female ports, all of which open in a direction common to these female ports.

[0050] Thus, each connection to these female ports is established simply by moving along said common direction Dx.

[0051] In a particular embodiment, the interface device of the present invention is further adapted to form an interface between an external device including a hemodialysis machine and an arterial line for connection to the patient system for transferring fluid from the patient system to the hemodialysis machine, the interface device further comprising:

[0052] a second port adapted to be connected to an inlet port of a hemodialysis machine, the second port being carried by said movable component of the interface device;

[0053] an arterial port carried by the stator to receive a fluid from the patient through the arterial line (specifically, the fluid is the patient's blood);

[0054] The interface device is further adapted to prevent fluid from traveling between the second port and the arterial port when the device is in its first configuration, and to allow fluid to travel between the second port and the arterial port when the device is in its second configuration.

[0055] This interface device enables both venous and arterial lines to be connected to the same hemodialysis machine, while using a single interface device allows:

[0056] By placing the interface device in its first configuration to simultaneously prevent fluid from traveling between the hemodialysis machine and the venous line and between the hemodialysis machine and the arterial line; otherwise

[0057] By placing the interface device in its second configuration, fluid is simultaneously allowed to pass between the hemodialysis machine and the venous line and between the hemodialysis machine and the arterial line.

[0058] Thus, it is possible to selectively allow or prevent fluid flow connection to both a vein and an artery using the same interface device.

[0059] This greatly facilitates the operation performed by medical personnel while reducing the risk of any operating errors.

[0060] For purposes of understanding the present invention, unless indicated to the contrary, any port of an interface device that is not explicitly mentioned as being connected to another port of the interface device should be considered isolated from all other ports of the interface device.

[0061] Furthermore, when it is stated that given ports are connected to each other, this means that there is fluid flow communication between these given ports.

[0062] Likewise, when two given ports are stated to be isolated from one another, this means that there is no fluid flow communication between the given ports.

[0063] The fluid passing through the interface device is a liquid, for example, blood, dialysate, physiological serum, medicinal fluid (drug in liquid form), or nutritional fluid (nutrient solution).

[0064] On the other hand, the present invention provides an interface assembly, which includes an interface device according to any embodiment of the present invention and an interface connection device including a plug and a plurality of flexible tubes, each flexible tube having one end connected to the plug and the other end carrying at least one connection link, each given connection link being used to establish a fluid flow connection between the flexible tube carrying the given connection link and a corresponding one of the ports of the external device, the plug being arranged to be mechanically connected to the interface device in a releasable manner, so that when the plug is mechanically connected to the interface device, each of the plurality of flexible tubes is fluidically connected to only one of the ports corresponding to it carried by the movable assembly.

[0065] This aspect of the invention is particularly advantageous because it enables a single plug having multiple ports to be used to connect all the ports of an external device to all the ports carried by the movable assembly of the interface apparatus.

[0066] This facilitates connecting the external device and the interface device together because the operator does not need to connect each port of the external device directly to the corresponding port of the interface device. The interface connection device and its flexible tube form an octopus-shaped device with independent connecting parts, which is easier to operate.

[0067] Once the ports of the external device are connected to the corresponding couplings of the interface connection device, the operator only has to connect the plug presenting the plurality of ports to the interface device on the patient side.

[0068] By facilitating these operations, the risk of connection errors is reduced and the operator's time is potentially saved.

[0069] The interface connection device preferably includes a cap configured to be removably mounted on the plug of the interface connection device, the cap defining a sealed internal volume between the plug and the cap so that each flexible tube connected to the plug can be fluidically connected to the other flexible tubes via the internal volume of the cap.

[0070] Thus, before connecting the plug of the interfacing device to the interfacing device, it is easy to evacuate the gas contained in the flexible tubes by flowing liquid through all the tubes to connect them to each other via the inner volume of the cap.

[0071] This helps reduce the time required to establish a reliable fluid flow connection between the external device and the patient system.

[0072] In another aspect, the present invention provides a hemodialysis system comprising an interface assembly according to any embodiment of the present invention and an external device including a hemodialysis machine.

[0073] In a hemodialysis system, a first port of the interface device is releasably connected to an outlet port of a hemodialysis machine via an interface connection device, and a second port of the interface device is releasably connected to an inlet port of the hemodialysis machine via an interface connection device.

[0074] The hemodialysis machine includes a pump configured to cause fluid to flow from an inlet port thereof to an outlet port thereof, and the hemodialysis machine also includes a venous line and an arterial line.

[0075] The venous tube is connected to the venous port of the interface device. In this example, the venous tube is used to connect to the patient's circulatory system in order to transfer blood from the hemodialysis machine to the circulatory system via the interface device and the interface connection device.

[0076] The arterial line is connected to the arterial port of the interface device. In this example, the arterial line is used to connect to the patient's circulatory system in order to transfer blood from the circulatory system to the hemodialysis machine via the interface device and the interface connection device.

[0077] The hemodialysis system of the present invention is advantageous for at least the reasons described above with reference to the interface device of the present invention. Finally, in another aspect, the present invention provides an interface connection device for connecting an external device to the interface device for injecting a fluid into a patient, the connection device being characterized in that it comprises a plug and a plurality of flexible tubes, each flexible tube having one end connected to the plug and another end carrying at least one connecting coupler, each given connecting coupler being used to fluidically connect the flexible tube carrying the given connecting coupler to a corresponding port of the external device corresponding to the given connecting coupler, the plug having a plurality of male ports, each male port opening on a face of the plug, and each flexible tube being fluidically connected to a single corresponding one of the male ports, and conversely, each male port being connected to a single corresponding one of the ports of the flexible tubes.

[0078] The connector device is used to group together a plurality of male ports on a common face of a plug so that the male ports can simultaneously establish fluid flow connections with corresponding ports formed in an interface device. BRIEF DESCRIPTION OF THE DRAWINGS

[0079] Other characteristics and advantages of the invention emerge clearly from the following description made by way of non-limiting indication and with reference to the accompanying drawings, in which:

[0080] [ Figure 1a ] Figure 1aA hemodialysis system 0 of the present invention is shown, which includes a hemodialysis machine 2, an interface device 1 of the present invention, an interface connection device 10 of the present invention (the interface device 1 and the interface connection device 10 forming the interface assembly 100 of the present invention), and a venous tube X1 and an arterial tube X2. The figure shows the interface device 1, the venous tube X1 and the arterial tube X2, the inlet port M1 and the outlet port M2 of the machine, and the interface connection device before being assembled together, which are assembled together for transferring fluid between the external device 2 and the patient system 3;

[0081] [ Figure 1b ] Figure 1b Shown Figure 1a all elements of the interface device 1, but connected together for transferring fluid between the external device 2 and the patient system 3, the interface device is shown in its first configuration P1, Stp1, in which the venous port Px1 and the arterial port Px2 are closed (in this example, the interface device 1 is provided with an external housing because it is to be implanted outside the body rather than fastened to the patient's bone);

[0082] [ Figure 1c ]、[ Figure 1d ]、[ Figure 1e ]、[ Figure 1f ]、[ Figure 1g ]、[ Figure 1h ]、[ Figure 1i ]、[ Figure 1j ] Figure 1c 、 1d , 1e, 1f, 1g, 1h, 1i and 1j show the corresponding successive different steps Stp1, Stp3a, Stp3b, Stp4, Stp5, Stp6B, Stp7A, Stp7B and Stp0 in the operation of the interface device 1 of the present invention suitable for hemodialysis;

[0083] [ Figure 2 ] Figure 2 The interface connection device 10 of the present invention is shown, which, when connected to an external device 2, has a cap 101 fastened to a plug so as to connect the flexible tubes 10b of the connection device to each other via the internal volume of the cap (thus filling the flexible tubes 10b with liquid fluid and exhausting gas therefrom);

[0084] [ Figure 3 ] Figure 3 shows an exploded view of the interfacing device 10 of the present invention;

[0085] [ Figure 4 ] Figure 4 shows an exploded view of an interface device 1 in a particular embodiment of the invention (specifically, the device having a base arranged to be secured to a patient's bone);

[0086] [ Figure 5 ] Figure 5 A first exploded view of an interface assembly 100 of the present invention is shown, the interface assembly comprising an interface device 1 and an interface connection device 10;

[0087] [ Figure 6 ] Figure 6 Shown Figure 5 a second exploded view of the interface assembly 100;

[0088] [ Figure 7 ] Figure 7 An interface device of the present invention adapted to be fastened to a patient's bone is shown;

[0089] [ Figure 8 ] Figure 8 The interface device 1 of the present invention is shown in a plurality of successive configurations, specifically a first configuration P1 (employed in step Stp1), an arterial lock access configuration P2 (employed in step Stp3a to remove the arterial lock contained in the arterial line X2), a venous lock access configuration P3 (employed in step Stp3b to remove the venous lock contained in the venous line X1), and a second configuration P6 (employed in step Stp4 to perform dialysis);

[0090] [ Figure 9 ] Figure 9 The interface device 1 of the present invention is shown in a plurality of successive configurations, in particular a venous return configuration P5 (adopted in step Stp5, which is performed at the end of dialysis to return blood and / or dialysate to the patient via the venous line X1, in which a venous lock may be placed, this configuration P5 being adopted after the device 1 has been in its second configuration P6, in order to perform dialysis), an arterial return configuration P4 (adopted in step Stp6B, which is used to return blood and / or dialysate to the patient via the arterial line X2, in which an arterial lock may be placed, this configuration P4 being adopted after the device 1 has been in its second configuration P6 for performing dialysis It is then adopted, and preferably adopted after it has adopted the configuration P5 and performed venous return), followed by a step Stp7A of placing the venous lock in place, which is performed when the device 1 is placed in the venous lock access configuration P3, followed by a step Stp7B of placing the arterial lock in place, which is performed when the device 1 is placed in the arterial lock access configuration P2, followed by a step Stp0 for disconnecting the connecting device 10 and the external device 2 from the interface device 1, which can be permanently maintained on the patient (external or in the form of a percutaneous implant), remaining attached to the venous line X1 and the arterial line X2. DETAILED DESCRIPTION

[0091] The present invention mainly relates to Figures 1a to 1jThe hemodialysis system 0 is shown.

[0092] The system 0 includes a venous tube X1 and an arterial tube X2, and an external device 2, which includes a hemodialysis machine 2 and an interface assembly 100 of the present invention.

[0093] The interface assembly 100 includes the interface device 1 of the present invention and the interface connection device 10 of the present invention.

[0094] The interface device of the present invention is designed firstly so that it can be fastened in fluid flow connection with tubes X1 and X2 and secondly so that the connecting device 10 can be directly connected to the interface device so that a fluid flow connection can be established between the external device 2 and the patient's circulatory system 3 via the connecting device 10 and the interface device 10, which are thus connected in series between the patient and the external device.

[0095] Each of the tubes X1 and X2 is placed in fluid flow communication with the circulatory system 3 of the patient 3. These venous tube X1 and arterial tube X2 preferably form part of a single catheter.

[0096] Each of the tubes X1 and X2 is preferably formed in a flexible tubing, for example made of a thermoplastic compatible with medical use (polyurethane, PEEK, silicone, etc.), to make it easier to handle and route between the circulatory system 3 and the interface device 1 .

[0097] The venous line X1 is basically used to inject fluid from the machine 2 to the patient, while the arterial line X2 is basically used to withdraw (aspirate) fluid from the patient for delivery to the hemodialysis machine 2 .

[0098] These tubes are connected to the circulatory system 3 via an arteriovenous fistula, or via a central catheter tunneled in the patient's body (a tunneled central catheter is a catheter that remains in place in the patient's body between two hemodialysis sessions), or via an implanted non-tunneled hemodialysis catheter (these tubes can form part of one or more catheters).

[0099] More precisely, the interface device 1 of the invention forms:

[0100] an interface between an external device (in this example a hemodialysis machine 2 ) and an arterial line X2 for connection to said circulatory system 3 of the patient in order to transfer fluid and / or blood from the system 3 to the hemodialysis machine 2 ; and

[0101] The interface between the hemodialysis machine 2 and at least the venous line X1 is used to transfer fluid and / or blood from the hemodialysis machine to the circulatory system 3 .

[0102] The interface device 1 comprises:

[0103] a first port Pm1 adapted to be connected to the outlet port M1 of the hemodialysis machine 2 , preferably removably connectable to the outlet port M1 of the hemodialysis machine 2 via a first coupling; and

[0104] a second port Pm2 adapted to be connected to an inlet port M2 of a hemodialysis machine, preferably releasably connectable to the inlet port M2 of the hemodialysis machine via a second coupling, possibly fixed to said first coupling;

[0105] a venous port Px1 for injecting blood into the venous tube X1 , the venous port Px1 preferably being releasably attached to the venous tube X1 via a coupling; and

[0106] Arterial port Px2, for receiving the patient's blood (ie, circulating the blood, for example, by suction), coming from arterial line X2, is preferably releasably attached to arterial line X2 via a coupling.

[0107] The second port Pm2 of the interface device 1 is adapted to transfer blood from the interface device 1 to the inlet port M2 of the hemodialysis machine 2 .

[0108] The hemodialysis machine comprises a pump M arranged to pump / circulate fluid from its inlet port M2 to its outlet port M1 .

[0109] The first port Pm1 of the interface device 1 is adapted to receive blood from the outlet port M1 in order to transfer it to the venous line X1.

[0110] The hemodialysis machine 2 is also adapted to exchange between the fluid it transfers (particularly the patient's blood) and a liquid dialysate to purify the fluid (blood). For this purpose, the hemodialysis machine has an internal circuit connected at one end to an inlet port M2 and at the other end to an outlet port M1.

[0111] The pump M of the hemodialysis machine is preferably a peristaltic pump for transferring fluid from the inlet port M2 to the outlet port M1 at a precisely controlled flow rate.

[0112] The internal circuit of the hemodialysis machine preferably comprises at least one semipermeable membrane allowing the exchange of fluid / blood with the chemically formulated dialysate and / or a filter for purifying the fluid / blood.

[0113] Preferably, the semipermeable membrane allows exchange between the circuit through which the patient's blood flows and a dialysis circuit (not shown). The dialysate circuit extends from a supply of previously prepared dialysate to a reservoir of used dialysate, passing through an area in contact with the semipermeable membrane for exchange with the patient's blood.

[0114] The hemodialysis machine 2 also has a debubbler D for removing air bubbles contained in the fluid being transferred through the hemodialysis machine 2. In this example, the debubbler D is connected in series between the inlet port M2 and the outlet port M1, and is preferably located between the port M2 and the membrane. If necessary, the machine may include additional debubblers to ensure that no fluid containing air bubbles is delivered to the patient.

[0115] The hemodialysis machine may further comprise corresponding detection means for detecting air bubbles, and / or impurities, and / or the fluid flow rate between its inlet port M2 and outlet port M1, and / or the fluid pressure through the machine 2, and / or the dialysate level in the dialysate supply connected to the machine 2 so that the dialysate is in contact with the semipermeable membrane.

[0116] The detection device(s) are connected to an electronic control unit (not shown) of the hemodialysis machine 2 for controlling the operation of the pump M in dependence on the measurements performed.

[0117] The electronics unit may also be connected to at least some of the sensors of the dialysate circuit and to actuators of the dialysate circuit, eg in order to control the dialysate flow rate through the dialysate circuit and / or dialysate dosage with other components.

[0118] The electronic unit may also be connected to one or more state sensors for sensing the state of the semipermeable membrane in order to control the operating parameters of the various actuators including the pump M based on measurements made using such state sensor(s).

[0119] The hemodialysis machine may also have a communication interface (not shown) adapted to detect the current configuration of the interface device 1 of the present invention so as to adjust the operation of the hemodialysis machine according to the current configuration detected in this manner. The communication interface may comprise electronic connection means for removably connecting the hemodialysis machine 2 to the interface device 1.

[0120] The communication interface may be adapted to:

[0121] a current configuration signal of the interface device 1 is transmitted from the interface device 1 to the hemodialysis machine 2, which indicates the current configuration adopted by the interface device 1; and / or

[0122] A configuration change signal is transmitted from the hemodialysis machine 2 to the interface device 1. The interface device 1 includes an actuator, such as a motor, for controlling a configuration change of the interface device 1 based on the configuration change signal received by the interface device 1, so as to cause the interface device to move from its current configuration to another configuration selected from a series of predefined configurations. The various configurations that the interface device can selectively adopt are described below.

[0123] Figures 1a to 1j, 8 and 9 show a series of configurations that the interface device can selectively adopt (the term "selectively" is used to indicate that at any given moment, the interface device can adopt only one of the listed configurations).

[0124] The interface device 1 has a third port PB1x and is adapted to selectively adopt a venous lock access configuration P3, Stp3b that is different from said first configuration P1 and second configuration P6 adopted in steps Stp1 and Stp4, respectively.

[0125] In this venous lock access configuration P3 (step Stp3b), the third port Pb1x is connected to the venous port Px1, while the first port Pm1 and the second port Pm2 are both isolated from the venous port Px1.

[0126] from Figures 4 to 8 It will be appreciated that the venous port Px1 is carried by the stator 1 b of the interface device 1 , whereas the first port Pm1 and the third port PB1x are carried by a movable assembly 1 a , in this example a rotor 1 a mounted for rotation relative to the stator 1 b .

[0127] The movable assembly 1 a is movable relative to the stator 1 b within a range optionally limited by an abutment.

[0128] The interface device 1 is arranged to pass from one configuration thereof to another configuration thereof by means of a movable assembly 1 a moving relative to the stator 1 b.

[0129] More specifically, the movable assembly 1 a has a face F1 visible from the outside of the interface device 1 and in which each port carried by the movable assembly 1 a opens.

[0130] The purpose of the fluid flow connection between the ports carried by the rotor 1 a and the ports carried by the stator 1 b is that there is only one friction area between the stator and the movable assembly in the path of the fluid flow connection.

[0131] This is advantageous because it simplifies the design of the device by minimizing the number of dynamic sealing points that need to be formed on the fluid flow path between the ports carried by the movable assembly 1a and the ports carried by the stator. This serves to minimize the risk of having areas of material retention on the respective paths between the ports of the movable assembly and the ports of the stator 1b.

[0132] This design also allows the device to be compact since multiple ports can be carried by a single movable component.

[0133] Preferably, the face (F1) of the movable assembly (1a) and the port carried by it are entirely inside the grooves of the stator.

[0134] The ports carried by the movable assembly 1 a are preferably female ports, all of which open in a direction Dx common to these female ports.

[0135] This allows the movable part 1 a to be compact while also being able to enter the female port by means of a single movement in translation along the direction Dx.

[0136] Each given configuration of the device is therefore defined by a given position of the movable part 1 a relative to the stator 1 b.

[0137] from Figure 1a 、 1e It will be appreciated that the interface device 1 is adapted to selectively employ:

[0138] a first configuration P1 which is adopted in the pre-connection step Stp0, the connection step Stp1, and the disconnection step; and

[0139] A second configuration P6 is employed during the dialysis step Stp4.

[0140] In its first configuration P1:

[0141] Preventing blood from traveling between the first port Pm1 and the venous port Px1; and

[0142] Blood is prevented from traveling between the second port Pm2 and the arterial port Px2.

[0143] This first configuration serves at least to isolate the machine 2 from the patient's circulatory system. Figure 1e In the dialysis step Stp4 shown, the first port Pm1 is connected to the venous port Px1 to allow blood to flow from the first port Pm1 to the venous port Px1, and the second port Pm2 and the arterial port Px2 are also connected together to allow blood to flow from the arterial port Px2 to the second port Pm2. In this second configuration P6, only ports Pm1, Px1, Pm2, and Px2 are open, and the other ports of the device are closed.

[0144] The second structure P6 is used to allow blood to travel in a loop continuously through the circulatory system 3, arterial tube X2, arterial port Px2, second port Pm2, inlet port M2, hemodialysis machine 2 and its internal circuit, outlet port M1, second port Pm1, venous port Px1, venous tube X1 and finally the circulatory system 3.

[0145] One of the advantages of the interface device 1 of the present invention is that it is possible to switch from one configuration to another simply by moving the rotor 1 a, without having to manually disconnect any port of the machine.

[0146] Thus, it is possible to allow or prevent the passage of fluid between the tubes X1 , X2 and the hemodialysis machine while limiting any risk of contamination of the patient.

[0147] In a preferred embodiment, the interface device may be arranged such that when it is in its first configuration P1 , the first port Pm1 and at least one of the other ports PR2 , PB1x carried by the movable assembly 1 a then communicate via an internal loop A10 of the interface device 1 .

[0148] Furthermore, in this mode, when the interface device 1 is in its second configuration P6 , communication is prevented between the first port Pm1 and the other ports PR2 , PB1 x , Pm2 carried by the movable assembly 1 a via the internal loop A10 .

[0149] like Figure 8 and Figure 9 As shown, the inner loop A10 is formed inside the stator and is open only toward the rotor 1 a.

[0150] Thus, in a first configuration, the first port Pm1 can be in communication with one or more other ports PR2, PB1x carried by the movable assembly so as to be able to degas at least some of the ports of the movable assembly and at least part of the connection device 10 while isolating the arterial line X2 and the venous line X1 when necessary.

[0151] The interface device 2 is further adapted to selectively adopt an arterial lock access configuration P2 , which is different from the first and second configurations P1 , P6 and the venous lock access configuration P3 .

[0152] In the arterial lock access structure P2 (such as Figure 1c 、 1i As shown, in step Stp3a), the third port Pb1x is connected to the arterial port Px2, while the first port Pm1 and the second port Pm2 are isolated from the arterial port Px2, and then the venous port Px1 and the arterial port Px2 are also isolated from each other.

[0153] When ports are referred to as being isolated from each other or as being isolated from one another, it is to be understood that the ports are not in fluid flow connection with one another.

[0154] The arterial lock access structure P2 acts via the third port Pb1x to enable a locking fluid to be aspirated from or injected into the arterial tube X2 to release the arterial tube and allow blood flow or fluid circulation, or to lock the arterial tube X2 to prevent blood from traveling thereto.

[0155] The locking fluid is a substance with anticoagulant and buffering functions to prevent blood from entering the tube containing the locking fluid. Optionally, the locking fluid may have an antiseptic function.

[0156] Typically, after a hemodialysis session, a locking fluid is injected into each tube, which remains in place until the next hemodialysis session. The locking fluid is used to prevent tube blockage and the need to replace the tubes.

[0157] By means of the interface device 1 , a locking fluid can be injected into the venous line X1 and / or the arterial line X2 or aspirated therefrom while the line or lines are connected to the interface device 1 .

[0158] Again, this reduces the need to handle couplings and ports and reduces associated risks to the patient.

[0159] In order to aspirate the locking fluid from the venous tube X1 or the arterial tube X2 , the system of the present invention may further include at least one locking fluid aspirating syringe B1x connected to the third port Pb1x via the interface device 10 .

[0160] It should be noted that the port of the interface connection device 10 for connection to the third port Pb1x has a flexible tube, which is suitable for connection to a device such as Figure 1a Two couplings placed in parallel as shown or as Figure 2 Three couplings are shown placed in parallel, each of which is suitable for receiving a syringe, such as a syringe B1x for aspirating locking fluid, or a syringe B1z for injecting locking fluid to lock tubes X1 and X2, or a syringe B1y for injecting physiological serum to flush tubes X1 and X2.

[0161] exist Figures 1a to 1j In the illustrated embodiment, it can be seen that the third port PB1x is designed to be connected to either the venous port Px1 or the arterial port Px2, or possibly to the return port Pr2 for injecting a fluid to be returned to the patient (e.g., physiological serum or liquid medication). Thus, this single third port Px1 can be used with each of the venous port Px1 or the arterial port Px2 to insert or aspirate a lock. To this end, the third port PB1x can be designed to be connected, in turn, to either a lock fluid aspiration syringe B1x or a lock fluid injection syringe B1z. Each syringe can be manually connected by the hemodialysis physician.

[0162] This solution is also advantageous because it makes it possible to perform a locking operation on either the venous port or the arterial port using the single third port PB1x.

[0163] To perform a venous lock or an arterial lock, it is sufficient to place the interface device in the venous lock access configuration or the arterial lock access configuration and inject into the arterial lock or the venous lock via one of the ports Px1 or Px2 connected to the third port Pb1x.

[0164] Thus, the interface device of the present invention can perform operations of removing or installing the locking fluid in the venous tube X1 and the arterial tube X2 while having the hemodialysis machine 2 and the venous tube X1 and the arterial tube X2 connected / attached to the ports involved in the interface device. Again, this limits any risk of contaminating the circulatory system by connecting or disconnecting the ports.

[0165] For this purpose, the system of the present invention may include an arterial injection syringe B1z for injecting a locking fluid, which is connected to the third port Pb1x so as to be able to inject the locking fluid into the arterial line X2.

[0166] In a preferred embodiment, the interface device further comprises a return port Pr2 carried by said movable component 1a, and the interface device 1 is further adapted to selectively adopt a venous return configuration P5 (adopted in step Stp5) which is different from the other configurations P1, P6, P3 which the device may adopt.

[0167] In this venous return configuration P5, the return port Pr2 is connected to the second port Pm2 (specifically, the connection is via a vent formed in the stator and at Figure 4 、 6 , 8, and 9) so that the return fluid can be injected into the hemodialysis machine 2, the first port Pm1 is then connected to the venous port Px1 and isolated from all other ports of the interface device, and the arterial port Px2 is then isolated from at least the venous port Px1, the first port Pm1 and the second port Pm2.

[0168] In the venous return structure P5 ( Figure 1f 、 9 In step Stp5 shown), the device 1 allows the fluid for reflux (reflux fluid) to travel only to the second port Pm2 of the hemodialysis machine, while allowing the hemodialysis machine to inject fluid into the venous port X1 via the outlet port M1 which is already connected to the first port Pm1 and the venous port PX1.

[0169] For this purpose, the system of the invention may comprise a device R2 for feeding a return fluid (e.g. a supply of physiological serum, dialysate, a drug in liquid form), which is connected to the return port Pr2 via the connection device 10 so as to be able to inject the return fluid into the interface device 1 when the interface device 1 is in its venous return configuration P5, STP5.

[0170] Because the hemodialysis machine 2 forms a circuit extending between its inlet port M2 and its outlet port M1, the hemodialysis machine pumps return fluid from its inlet port M2 toward its outlet port M1, causing the blood contained in the machine to travel and flow back to the venous tube X1 and then back to the patient's circulatory system 3.

[0171] Thus, the amount of blood contained in the hemodialysis machine 2, in the venous line X1 and in the tubing connecting the hemodialysis machine 2 to the interface device 1 can be returned to the patient. This is particularly important in order to limit the amount of blood lost by the patient during hemodialysis.

[0172] In a preferred embodiment, the device 1 is further adapted to selectively adopt, in step Stp6B, an arterial return configuration P4 that is different from the other configurations P1 , P6, P2, P3, P5 that the interface device can adopt.

[0173] In the arterial return structure P4 (see Figure 1g and 9 In step Stp6B), the return port Pr2 is connected to the second port Pm2 (specifically, this connection occurs via the internal loop A10 formed in the stator) so as to be able to inject the return fluid into the external device 2, the first port Pm1 is then connected to the arterial port Px2 and isolated from all other ports of the interface device, and the venous port Px1 is isolated from at least the arterial port Px2, the first port Pm1 and the second port Pm2.

[0174] In this arterial return configuration P4 in step Stp6B, the return fluid travels from the return port Pr2 to the second port Pm2, then leaves it via the machine M and its debubbler D and travels through the first port Pm to the arterial port Px2 (the interface device 1 in the arterial return configuration is connected together, which supports Pm1 and Px2, isolating them from the other ports of the interface device).

[0175] In an embodiment not shown, in a backflow configuration, both the venous port and the arterial port can be connected to the backflow port Pr2 or to the first port Pm1 so that backflow is performed simultaneously. This solution saves time during backflow, but it has the disadvantage that the volume of fluid returned to each tube X1 and X2 cannot be controlled.

[0176] As mentioned above, the return fluid may be physiological serum.

[0177] In this arterial return configuration P4 , the arterial tube X2 is filled with return fluid, and the blood present in the tube X2 is pushed toward the circulatory system 3 .

[0178] This return of blood limits blood loss during hemodialysis and avoids the risk of clogging of the arterial line X2.

[0179] In a particular embodiment, the interface device may be adapted such that when it is in its first configuration P1 (step Stp0 and / or step Stp1 ), its return port Pr2 is then connected to at least one of said first port Pm1 and second port Pm2 .

[0180] Thus, the first port Pm1 and the second port Pm2 may be degassed by injecting a (liquid) fluid via the return port PR2 .

[0181] In certain embodiments, the interface device 1 may include a motor-driven control mechanism (not shown) for moving the movable assembly 1a relative to the stator 1b, thereby causing the device 1 to progress from one configuration thereof to another in a predefined series of configurations.

[0182] For example, the control mechanism may act directly on the movable component, or it may act indirectly by moving the plug 10 .

[0183] In other words, the control mechanism is used to switch the device from a current configuration to another selected configuration of the device, wherein the other configuration is selected from a variety of different configurations that the device can selectively adopt.

[0184] The sequencing of the various configurations required to fully perform hemodialysis will be described in detail below.

[0185] As mentioned above, the connection between the machine 2 and the interface device occurs via the interface connection device 10, which includes a plug 10a and a plurality of flexible tubes 10b, each of which is connected to the plug 10a at one end and carries at least one connection coupling 10c at the other end (each connection coupling is carried by a single flexible tube of its corresponding connection device, where such a connection coupling can be a male coupling or a female coupling, for example a Luer standard coupling).

[0186] Each given connection coupling 10c is intended to establish a fluid flow connection between the pipe carrying the given coupling 10c and one of the ports of the external device 2 corresponding to said given connection coupling 10c.

[0187] The plug 10a is arranged to be releasably mechanically connected to the interface device 1 such that when the plug 10a is mechanically connected to the interface device 1 each flexible tube 10b of a plurality of flexible tubes is fluidly connected with a respective single port carried by the movable assembly 1a.

[0188] The connecting couplings 10c are movable relative to each other within the range of freedom afforded by the flexible pipe 10b.

[0189] The plug 10a of the connection device 10 and the movable assembly 1a of the interface device 1 are shaped so that when the plug 10a is mechanically connected to the interface device 1, it is constrained to move with the movable assembly / rotor 1a when the rotor 1a moves relative to the stator 1b.

[0190] Thus, when the plug 10a is mechanically connected to the interface device 1, a user can move the plug 10a relative to the stator 1b, thereby moving the movable assembly 1a relative to the stator 1b, in order to switch the interface device 1 from one of its configurations to another.

[0191] In order to enable the plug 10a to be constrained to move with the movable component 1a, two pins 10d are carried by the plug 10a, and two grooves 1a1 complementary to the pins 10d are formed in the movable component 1a.

[0192] These pins 10d and grooves 1a1 are designed so that the plug 10a can be assembled on the movable component 1a with the plug 10a being oriented in only one position relative to the movable component 1a. The pins 10d and grooves 1a1 thus form a keying arrangement.

[0193] Preferably, the pins 10 d have a sufficient length to enable each pin 10 d to penetrate into a corresponding one of the grooves 1 a 1 , while the remainder of the plug 10 a remains at a distance from the interface device 1 .

[0194] Thus, the pins 10 d contribute to pre-positioning and guiding of the plug 10 a relative to the movable assembly when the plug is moved towards the interface device 1 , so as to mechanically connect the plug 10 a to the interface device 1 .

[0195] The interface device 10 further comprises an indicator 10e for indicating the position of the plug, which indicator is visible from the outside of the interface device 10 so as to inform the operator of the current position of the plug relative to the stator 1b when the plug 10a is mechanically connected to the interface device 1.

[0196] Specifically, if Figure 1a 、 1b As shown in Figures 3, 5 and 6, the indicator 10e is composed of a pointer extending radially relative to the longitudinal axis of the plug.

[0197] The pointer is accessible from outside the interface assembly 100 so that an operator can manipulate the pointer to move the plug 10a relative to the stator when the plug is mechanically connected to the interface device 1 .

[0198] Preferably, the interfacing device 10 comprises at least one mechanical latch 10f arranged to:

[0199] When the plug 10a is mechanically connected to the interface device 1 and when the plug 10a is not in a predetermined position relative to the stator 1b, preventing the plug 10a and the interface device 1 from moving apart; and

[0200] When the plug 10a is mechanically connected to the interface device 1, and when the plug 10a is in a predetermined position relative to the stator 1b, the plug 10a and the interface device 1 are allowed to move apart.

[0201] Thus, the at least one latch 10f allows the plug 10a and the interface device 1 to be mechanically coupled together and only disengaged when the plug 10a is in a predetermined position relative to the stator 1 b.

[0202] Since the position of the plug 10a relative to the movable component 1a is determined (for example, by the pin 10d), and since the position of the movable component relative to the stator 1b determines the current configuration adopted by the interface device 1, the plug 10a and the interface device 1 are only allowed to be coupled or uncoupled when the plug is in a predetermined position relative to the stator, thereby ensuring that such coupling or uncoupling always occurs when the interface device 1 is in a predefined given configuration.

[0203] In particular, the at least one mechanical latch 10f is arranged to allow the plug 10a and the device apparatus 1 to be separated only when the interface device 1 is in its first configuration P1, Stp1 and then prevent fluid flow between the ports Pm1, PR2, Pm2, PB1x and each of the venous port Px1 and arterial port Px2.

[0204] Therefore, the plug 10 a can be connected or disconnected only when the venous port Px1 and the arterial port Px2 are fixed to prevent any fluid from flowing through the venous tube X1 and the arterial tube X2 .

[0205] from Figure 3 I understand. Figure 3 An interfacing device 10 is shown comprising a connection plate 10g surrounding a plug 10a.

[0206] The connection plate 10g is formed as follows:

[0207] First, when the plug 10a is mechanically connected to the interface device 1, the connection disk is constrained to rotate together with the stator 1b; and

[0208] Second, the connection plate 10g is allowed to rotate relative to the plug 10a extending to the inside of the connection plate 10g.

[0209] The latch comprises two arms 10f arranged on either side of the connection plate 10g and mounted for rotation relative to the connection plate 10g around the plug 10a.

[0210] Each of these arms presents at one end a respective catch 10f1 , each of which is arranged to penetrate into an annular groove 1b2 formed in the stator 1b when the plug 10a is mechanically connected to said interface device 1 .

[0211] When positioned in the annular groove 1 b 2 , each latch 10 f 1 is opposite to the plug 10 a away from the interface device 1 .

[0212] Therefore, in order to allow the plug 10a to be separated from the interface device 1, it is necessary to initially move the latch 10f1 out of the annular groove 1b2, and to do this it is necessary to pivot the arm 10f relative to the connection plate 10g.

[0213] from Figure 1a 、 1b As can be understood from Figure 3, the interface connection device 10 includes an indicator ring 10h carrying the pointer 10e.

[0214] The indicator ring 10h is mechanically fixed to the plug 10a so that it rotates together with the plug 10a during movement of the plug 10a relative to the stator 1b.

[0215] The indicator ring 10h comprises two cutouts 10h1 and 10h2, each of which allows access to a respective one of the arms 10f when the plug 10a is in a first predetermined angular position relative to the connection plate 10g carrying the arms 10f.

[0216] The indicator ring 10h is arranged to prevent the arm 10f from pivoting relative to the connection disc 10g whenever the indicator ring 10h is in an angular position (relative to the connection disc 10g) other than said first predetermined angular position relative to the connection disc 10g.

[0217] Therefore, a connection between the plug and the connection device 1 is only possible if:

[0218] First, if the plug 10a is in a predetermined angular position relative to the movable component 1a; and

[0219] Secondly, if the arm 10f is free to pivot relative to the connection disk 10g, that is, if the plug 10a and the indicator ring 10h are in the first predetermined angular position relative to the connection disk 10g.

[0220] Preferably, the plug 10a presents a plurality of male ports, each male port being oriented to penetrate into a respective one of the corresponding ports Pm1, PR2, Pm2, PB1x carried by the movable component 1a, thereby establishing a plurality of fluid flow connections between the male ports carried by the plug 10a and the corresponding ports carried by the movable component 1a.

[0221] Preferably, the plug 10a and the flexible tube are made of a polymer material, while at least one of the movable assembly 1a and the stator 1b is at least partially made of a metallic material.

[0222] The use of polymeric materials enables the removable interfacing device 10 to be obtained at a lower cost than an interfacing device 1 having at least one portion made of a stronger and therefore more expensive metal.

[0223] The metal material may be selected from stainless steel alloy, titanium alloy or some other biocompatible metal alloy.

[0224] Therefore, the interface connection device 10 can be designed for single use (the connection device 10 is a consumable item), while the interface device 1 is designed for multiple use.

[0225] It should be noted that the stator of the interface device 1 may have a metal base 1 j designed to be implanted on the patient's bone and remain there permanently.

[0226] like Figure 4 、 5 As shown in Figures 6 and 7, the metal base 1j may have holes for passing screws so as to fix the base 1j to the patient's bone by screw fastening.

[0227] From these Figures 4 to 7 It can be understood that the stator of the interface device 1 may further include an insert 1k designed to define a first fluid passage 1k1 and a second fluid passage 1k2, each fluid passage having a curved portion.

[0228] A first of these channels 1 k1 has a first end facing a first passage opening through a disk 1 b 1 of the stator 1 b , situated in the internal enclosure 1 b 3 of the stator 1 b , to form said venous port Px1 of the interface device 1 .

[0229] A second of these channels 1 k2 has a first end facing a second passage opening through the disc 1 b 1 of the stator 1 b , so as to form said arterial port Px2 of the interface device 1 .

[0230] A first of these channels 1k1 has a second end designed to be connected in series with the venous line X1 in a fluid flow connection, this fluid flow connection possibly being achieved by a first specific coupling 1k10 so as to be reversible.

[0231] Likewise, a second of these channels 1k2 has a second end designed to be fluidically connected in series with the arterial tube X2, this fluidic connection possibly being achieved by a second specific coupling 1k20 so as to be reversible.

[0232] Each of the channels 1k1 and 1k2 of the insert 1k has a bend to allow the venous tube X1 and the arterial tube X2 to extend longitudinally in a plane perpendicular to the direction Dx along which the ports carried by the movable assembly 1a extend. This creates a more compact device in which the stator can be placed against a patient, with the venous tube X1 and the arterial tube X2 extending along the patient's outer surface, while the ports carried by the movable assembly 1a extend perpendicular to that outer surface.

[0233] This makes it easier to connect the interfacing device 10 to an interface device 1 that remains permanently on the patient. A cover (not shown) is put in place over the interface device 1 to protect it between treatment sessions (the port for connecting the external device 2 is sealed by the cover).

[0234] like Figures 4 to 7 As shown, the movable assembly 1a is preferably a rotor 1a in the form of a disc, which is rotatably mounted within said inner enclosure 1b3 of the stator 1b, the inner enclosure having a cylindrical inner bore.

[0235] The mechanism for indexing the rotor relative to the inner shell 1b3 is provided in the form of a spring placed in a radial blind hole 1a1 of the rotor, a spring 1a2 placed in the hole 1a1 and a ball 1a3 pushed by the spring against the cylindrical inside annular surface of the inner shell 1b3.

[0236] The inner casing 1b3 is provided with a plurality of radial perforations 1b30, the diameter of which is smaller than that of the balls and which are located on the path followed by the balls 1a3 when the rotor rotates.

[0237] Thus, each time the ball penetrates one of the perforations 1 b 30 , the rotation of the rotor 1 a relative to the stator 1 b is indexed. Each indexed position of the rotor corresponds to a single one of the configurations that can be adopted by the interface device 1 .

[0238] The stator 1 b comprises a disc 1 b 1 placed inside said inner enclosure 1 b 3 of the stator 1 b .

[0239] The discs of the rotor 1 a comprise surfaces intended to be pressed against complementary surfaces forming part of the stator discs 1 b 1 in order to provide a seal to these surfaces, thereby preventing any leakage of fluid along these surfaces of the discs.

[0240] In order to enable the disc 1 b 1 of the stator 1 b to be pressed against the disc of the rotor 1 a , said internal casing 1 b 3 of the stator 1 b comprises an axial abutment 1 b 4 , in particular an elastic ring 1 b 4 , against which the disc of the rotor 1 a rests.

[0241] On one side, the stator disk 1 b 1 rests on the disk of the rotor 1 a , while on its other side it rests on an insert 1 k defining a first fluid passage 1 k 1 and a second fluid passage 1 k 2 .

[0242] In this example, the rotor and stator discs are pressed against each other by an insert 1 k , which is made of an elastically compressible material such as silicone or latex.

[0243] The stator and rotor disks thus form a disk stack compressed between the elastic ring 1 b 4 and the insert 1 k .

[0244] Such an assembly is advantageous because, by removing the elastic ring 1 b4 from the inner enclosure 1 b3 , the stator disks 1 b 1 and the disks of the rotor 1 a can be disassembled for maintenance of the interface device 1 and possible replacement of the disks.

[0245] The operation of the assembly 100 of the present invention will now be described.

[0246] Figure 2 The preparatory step is shown, in which the interface connection device 10 is provided with a cap 101 which is assembled on the plug 10a to define a closed space in which each flexible tube 10b of the connection device opens. This space enables the flexible tubes 10b to communicate with each other.

[0247] The coupling means 10c of these connection means are in fluid flow connection with ports of the external equipment 2, ie the machine 2, the equipment R2 (for supplying liquids, such as physiological serum) and the syringes Blx, Bly, Blz.

[0248] The pump of the machine 2 is put into operation, causing the liquid to flow around the circuit between the machine 2 and the interface connection 10, passing through the debubbler D for removing air bubbles from the liquid.

[0249] The machine 2 continues to circulate liquid until it or the operator detects that the circuits of the machine and the interface device contain only liquid.

[0250] For example, the liquid is physiological serum.

[0251] exist Figure 2 After the preparatory steps shown, the machine's pump is stopped, the flexible tube is optionally clamped, the cap 101 is removed, and the first step ( Figure 1b Step Stp1) is shown, which comprises mechanically connecting a port of the plug 10a to a port of the interface device 1 in its first configuration.

[0252] In this example, venous tubing X1 and arterial tubing X2 have been connected to corresponding ports Px1 and Px2 of the interface device 1 .

[0253] Thus, the port of the external component 2 is connected to the interface device via the interface connection device 10 .

[0254] The device R2 connected to the port PR2 may be a special port of the hemodialysis machine 2 that is used only when returning blood at the end of hemodialysis, or it may be a bag of fluid or medicine for injection at the end of hemodialysis.

[0255] Then the interface device 1 is switched to the arterial lock engagement configuration P2 ( Figure 1c Step Stp3a) shown in FIG.

[0256] The aspiration syringe B1x is then activated. The locking fluid contained in the arterial line X2 is then aspirated.

[0257] The actuation of the syringe(s) may be driven by a motor and controlled by a control unit of the external device.

[0258] After the arterial lock has been aspirated, the pump of the external device 2 is put into operation and the small amount of gas contained in the interface device is then vented to the degasser. The connecting device 10 and the interface device 1 are now completely filled with liquid.

[0259] Then the interface device 1 is switched to the vein lock access configuration P3 ( Figure 1d Step Stp3b) shown in FIG.

[0260] The aspiration syringe B1x or another syringe is then activated. The locking fluid contained in the intravenous line X1 is then aspirated.

[0261] Once the locking fluid is removed from tubes X1 and X2, the interface device switches to its second configuration P6 (step Stp4). In this second configuration P6, arterial tube X2 is connected to inlet port M2 via port Pm2, and venous tube X1 is connected to outlet port M1. The patient's blood can then circulate in a loop through the hemodialysis machine 2 to be dialyzed therein. The small amount of gas contained in the interface device is aspirated and discharged by the debubbler D.

[0262] Once hemodialysis has been performed and in an optional manner, it may be necessary to return a specific liquid to the patient. In this case, the liquid can be transmitted via a return port PR2 forming part of the interface device. The port PR2 can be connected to a specific blood outlet R2 of the hemodialysis machine or to a bag R2 containing blood or medication.

[0263] For this purpose, the control mechanism is actuated so that the interface device switches to the venous return configuration P5 ( Figure 1f). In this configuration P5, port PR2 is connected to port Pm2, and venous line X1 is connected to outlet port M1. Return fluid then flows from device R2 to venous line X1, passing through the first tube of connecting device 10, port Pr2, port Pm2, the second tube of connecting device 10, inlet port M2, hemodialysis machine 2, outlet port M1, the third tube of connecting device 10, port Pm1, port Px1, and finally reaching venous line X1.

[0264] Once this step Stp5 is completed, the interface device 1 is then switched to the arterial return configuration P4 ( Figure 1g Step 6B) shown in FIG, which allows:

[0265] The arterial port Px2 and / or arterial line X2 are closed (possibly via connection to port PB1x); and

[0266] The peripheral device R2 communicates with the machine inlet port M2 via the return port PR2 and the second port Pm2.

[0267] The detector means can detect the arrival of physiological serum and thus the end of the arterial return maneuver.

[0268] When a predetermined volume of liquid has returned to the arterial line X2, the return operation is completed.

[0269] Once step Stp6B is terminated, the interface device 1 is switched to the vein lock access configuration P3 ( Figure 1h , which first serves to allow syringe B1z to communicate with intravenous line X1 via port PB1x and port Px1.

[0270] In this locked configuration, port Px2 is closed.

[0271] The locking liquid leaves the injection syringe B1z and enters the intravenous line X1.

[0272] Once step Stp7A is terminated, the interface device 1 is switched to the arterial lock engagement configuration P2 ( Figure 1i 7B), which is first used to allow syringe B1z to communicate with arterial line X2 via port PB1x and port Px2.

[0273] In the arterial lock access configuration P2, port Px2 is closed.

[0274] The locking liquid leaves the injection syringe B1z and enters the arterial line X2.

[0275] After the lock has been injected in this manner, the connecting device 10 can be separated from the interface device 1 , which is then in its first configuration P1 , as shown. Figure 1j As shown in step Stp0.

[0276] The interface device 1 of the invention is particularly easy to use since it can be switched from any of its configurations to any of its other configurations simply by moving the movable assembly 1 a relative to the stator 1 b.

Claims

1. An interface device (1) between an external device (2) and at least one venous tube (X1) for connection to a patient system (3) in order to transfer a fluid from the device to the patient system, the interface device (1) comprising at least: - a first port (Pm1) adapted to be connected to an outlet port (M1) of the external device (2); as well as - a venous port (Px1) for injecting the fluid into the venous tube (X1); The interface device is adapted to selectively adopt a first configuration (P1, Stp1) in which fluid is prevented from passing between the first port (Pm1) and the venous port (Px1), and a second configuration (P6, Stp4) in which the first port (Pm1) is connected to the venous port (Px1) to allow fluid to pass from the first port (Pm1) to the venous port (Px1), the interface device (1) being characterized in that: - comprising a third port (PB1x) and adapted to selectively adopt a venous lock access configuration (P3, Stp3b) different from the first configuration (P1, STP1) and the second configuration (P6, Stp4), wherein the third port (PB1x) is connected to the venous port (Px1) in the venous lock access configuration (P3, Stp3b) while the first port (Pm1) is isolated from the venous port (Px1); and wherein - the venous port (Px1) is carried by the stator of the interface device, the first port (Pm1) and the third port (PB1x) are carried by a movable component (1a) of the interface device (1) movable relative to the stator (1b), the interface device being arranged to pass from any one of its configurations to its other configuration by movement of the movable component (1a) relative to the stator.

2. The interface device (1) according to claim 1, characterized in that The movable component is a rotor mounted for rotation relative to the stator.

3. The interface device (1) according to claim 1 or 2, characterized in that The movable component (1a) has a face (F1) visible from the outside of the interface device (1), and each of the ports carried by the movable component (1a) opens in the face.

4. The interface device (1) according to claim 3, characterized in that The face (F1) of the movable component (1a) and the port carried by the movable component are completely located within the groove of the stator.

5. The interface device according to claim 1, wherein: The ports carried by the movable assembly are female ports, opening in a common direction (Dx) with these female ports.

6. The interface device (1) according to claim 1, characterized in that Also included is a second port (Pm2) carried by the movable component of the interface device (1), the interface device being further adapted so that in the venous lock access configuration, both the first port (Pm1) and the second port (Pm2) are isolated from the venous port.

7. The interface device (1) according to claim 6, characterized in that The interface device is adapted to form an interface between the external device and an arterial tube (X2), the external device comprising a hemodialysis machine (2), the arterial tube being adapted to be connected to the patient system (3) for transferring fluid from the patient system to the hemodialysis machine, the second port (Pm2) being adapted to be connected to an inlet port (M2) of the hemodialysis machine, the interface device (1) further comprising an arterial port (Px2) carried by the stator for receiving patient fluid from the arterial tube (X2); The interface device (1) is further adapted to prevent fluid from traveling between the second port (Pm2) and the arterial port (Px2) when the interface device is in its first configuration (P1, Stp1), and to allow fluid to travel between the second port (Pm2) and the arterial port (Px2) when the interface device is in its second configuration (P6, Stp4).

8. The interface device (1) according to claim 1, characterized in that It is also suitable for enabling, when the interface device is in its first configuration (P1), communication between the first port (Pm1) and at least one other of the ports (PR2, PB1x) carried by the movable component (1A) via an internal circuit (A10) of the interface device (1), and for preventing communication between the first port (Pm1) and the other ports (PR2, PB1x, Pm2) carried by the movable component (1A) via the internal circuit (A10) when the interface device is in its second configuration (P6, Stp4).

9. The interface device according to claim 7, characterized in that: Suitable for selectively adopting an arterial lock access structure (P2, Stp3a), which is different from the first structure (P1, STP1) and the second structure (P6, Stp4), and different from the venous lock access structure (P3, Stp3b), in which the third port (Pb1x) is connected only to the arterial port (Px2), while the first port (Pm1) and the second port (Pm2) are isolated from the arterial port (Px2), and the venous port and the arterial port (Px1, Px2) are also isolated from each other.

10. The interface device according to claim 7, characterized in that: It also includes a return port (Pr2) carried by the movable component (1a), the interface device is suitable for selectively adopting a venous return structure (P5, Stp5) different from other structures (P1, P6, P2, P3, Stp1, Stp4) of the interface device, the return port (Pr2) is connected to the second port (Pm2) in the venous return structure (P5, Stp5) so that the return fluid can be injected into the external device, the external device includes a hemodialysis machine (2), the first port (Pm1) is further connected to the venous port (Px1) and isolated from all other ports of the interface device, and the arterial port (Px2) is isolated from at least the venous port (Px1), the first port (Pm1) and the second port (Pm2).

11. The interface device according to claim 10, characterized in that: The interface device (1) is suitable for selectively adopting an arterial return structure (P4, Stp6B) that is different from other structures (P1, P6, P2, P3, P5, Stp1, Stp4, Stp5) of the interface device, the return port (Pr2) is connected to the second port (Pm2) in the arterial return structure (P4, Stp6B) so that the return fluid can be injected into the external device including the hemodialysis machine (2), the first port (Pm1) is further connected to the arterial port (Px2) and isolated from all other ports of the interface device, and the venous port (Px1) is isolated from at least the arterial port (Px2), the first port (Pm1) and the second port (Pm2).

12. The interface device according to claim 10 or 11, characterized in that: The interface device is adapted such that, when it is in its first configuration (P1, Stp1), its return port (Pr2) is in turn connected to at least one of the first port (Pm1) and the second port (Pm2).

13. The interface device according to claim 1, wherein: The interface device (1) comprises a motor-driven control mechanism and is arranged to move the movable component (1a) relative to the stator (1b) so as to change the interface device from one configuration thereof to another configuration thereof.

14. An interface assembly (100), comprising an interface device (1) according to any one of claims 1 to 13 and an interface connection device (10) comprising a plug (10a) and a plurality of flexible tubes (10b), each of the flexible tubes having one end connected to the plug (10a) and the other end carrying at least one connection link (10c), each given connection link (10c) being used to establish a fluid flow connection between the flexible tube carrying the given connection link (10c) and a corresponding one of the ports of the external device (2), the plug (10a) being arranged to be mechanically connected to the interface device (1) in a releasable manner, so that when the plug (10a) is mechanically connected to the interface device (1), each of the plurality of flexible tubes (10b) is fluid flow connected only to one of the ports corresponding thereto carried by the movable assembly (1a).

15. The interface assembly (100) according to claim 14, characterized in that The plug (10a) and the movable component (1a) of the interface device (1) are shaped so that when the plug (10a) is mechanically connected to the interface device (1), the plug (10a) is constrained to move with the movable component (1a) when the movable component (1a) moves relative to the stator (1b).

16. The interface assembly (100) according to claim 15, characterized in that The interface connection device (10) comprises an indicator (10e) for indicating the position of the plug, the indicator being visible from the outside of the interface connection device so as to inform an operator of the current position of the plug relative to the stator when the plug (10a) is mechanically connected to the interface device (1).

17. The interface assembly (100) according to any one of claims 14 to 16, characterized in that The interface connection device (10) comprises at least one mechanical latch (10f), the mechanical latch being arranged to: When the plug (10a) is mechanically connected to the interface device (1) and the plug (10a) is not in a predetermined position relative to the stator (1b), preventing the plug (10a) and the interface device (1) from moving apart; and When the plug (10a) is mechanically connected to the interface device (1) and the plug (10a) is in a predetermined position relative to the stator (1b), the plug (10a) and the interface device (1) are allowed to move apart.

18. The interface assembly (100) according to claim 14, characterized in that The plug (10a) presents a plurality of male ports, each male port being oriented to penetrate into a corresponding one of the respective ports (Pm1, PR2, Pm2, PB1x) carried by the movable component (1a), thereby establishing a plurality of fluid flow connections between the male ports carried by the plug (10a) and the respective ports carried by the movable component (1a).

19. The interface assembly (100) according to claim 14, characterized in that The plug (10a) and the flexible tube are made of a polymer material, while at least one of the movable component (1a) and the stator (1b) is at least partially made of a metallic material.

20. A hemodialysis system (0), comprising an interface assembly (100) according to claim 14, wherein the interface assembly comprises an external device having a hemodialysis machine (2), the first port (Pm1) of the interface device (1) being releasably connected to the outlet port (M1) of the hemodialysis machine (2) via the interface connection device (10), and the interface device (1) further comprising a second port (Pm2) releasably connected to the inlet port (M2) of the hemodialysis machine via the interface connection device (10), the hemodialysis machine comprising a pump (M), the pump (M) being arranged to cause a fluid to flow from its inlet port (M2) to its outlet port (M1), the hemodialysis machine further comprising A venous tube (X1) and an arterial tube (X2), wherein the venous tube (X1) is connected to the venous port (Px1) of the interface device (1), and the venous tube (X1) is used to connect to the patient's circulatory system (3) so as to transfer blood from the hemodialysis machine (2) to the circulatory system (3) via the interface device (1) and the interface connection device (10), and the arterial tube (X2) is connected to the arterial port (Px2) of the interface device (1), and the arterial tube (X2) is used to connect to the patient's circulatory system (3) so as to transfer blood from the circulatory system (3) to the hemodialysis machine (2) via the interface device (1) and the interface connection device (10).

21. The hemodialysis system according to claim 20, characterized in that The system comprises a locking fluid aspiration syringe (B1x) connected to the third port (Pb1x) via the interface connection device (10) so as to be able to aspirate locking fluid from the arterial line (X2).

22. An interface connection device (10) for connecting an external device (2) to an interface device (1) as claimed in claim 1 so as to inject a fluid into a patient, the interface connection device being characterized in that it comprises a plug (10a) and a plurality of flexible tubes (10b), each of the flexible tubes having one end connected to the plug (10a) and the other end carrying at least one connecting link (10c), each given connecting link (10c) being used to connect the flexible tube carrying the given connecting link (10c) to a corresponding port of the external device (2) corresponding to the given connecting link (10c) for fluid flow, the plug (10a) having a plurality of male ports, each of the male ports opening in a face of the plug, and each flexible tube being fluid flow connected to a single corresponding one of the male ports, and conversely, each of the male ports being connected to a single corresponding one of the flexible tubes.

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