ITMI20111282A1 - DEVICE FOR MEDICAL USE FOR THE COLLECTION AND TRANSIT OF BLOOD, BLOOD DERIVATIVES AND / OR FLUIDS FILLING AND EXTRACORPOREAL CIRCUIT INCLUDING SUCH DEVICE - Google Patents

Description

DESCRIPTION

DEVICE FOR MEDICAL USE FOR COLLECTION AND TRANSIT OF BLOOD, BLOOD DERIVATIVES AND / OR FILLING FLUIDS AND EXTRA-BODY CIRCUIT INCLUDING THIS DEVICEâ €

FIELD OF THE TROVATO

The invention refers to a collection device or tank for medical use for the collection and transit of blood and / or its derivatives and / or filling fluids and to an extracorporeal circuit comprising this tank.

In particular, the invention is used in extracorporeal blood circulation, for example during surgical treatments when it is necessary to provide assistance or a replacement of cardiac and / or pulmonary function.

In such situations, an extracorporeal circuit is used to collect the blood from a patient undergoing treatment, conveying it to a reservoir for the collection of fluid and then returning it, after appropriate treatment, to the patient himself.

The device or reservoir object of the invention can be used as an independent component within an extracorporeal circulation system comprising for example a blood sampling line, a pump, a heat exchanger, an oxygenating section, a blood return line to the patient, or the collection device or reservoir according to the invention and possibly a heat exchanger can be an integral part of an oxygenator with a membrane integrating in a single piece,

STATE OF THE ART

Extracorporeal circuits of the so-called â € œopenâ € type are currently known which comprise a venous branch for blood sampling, at least one rigid reservoir connected above the atmosphere and at least one return line for the treated blood (for example filtered and / or oxygenated) to the patient.

This first type of circuit using a rigid tank has the drawback of typically offering an extensive contact surface between the free surface of the blood in the tank and the air, with consequent possibility of activation of the air-blood contact phase and therefore with the development of reactive phenomena on the part of the patient that trigger inflammation, complement activation and coagulation, certainly undesirable during extracorporeal circulation.

Alongside the â € œopenâ € systems described above using rigid reservoirs, the so-called â € œclosedâ € extracorporeal circulation systems have also spread.

The latter comprise a venous line for taking blood from the patient, at least one bag capable of accommodating a predetermined quantity of blood, and a line for returning the treated blood to the patient himself.

Thanks to the use of closed bags there is the advantage of minimizing and almost eliminating contact between air and blood.

The typical disadvantages of â € œclosedâ € systems are primarily linked to the greater operational complexity due to the presence of an additional module (bag) connected via a line to a rigid tank containing the filtered blood; secondly, any air bubbles present in the venous line are not automatically eliminated as the bag is a closed tank and therefore to separate and release any air trapped in the bag to the outside, it must be provided , in its upper part, of a drain.

If the venous line carries numerous air bubbles, there is also the risk that the deformable sacs accumulate an excessive amount of air.

In this case the circulation pump typically present downstream of the bag could aspirate one or more bubbles present in the bag itself, sending them to the patient, with very serious consequences for the latter.

A system to try to alleviate the inconvenience caused by air bubbles that may be present inside the venous line involves using de-foaming membranes, and to maintain an adequate level of blood in the bag, as well as to put â € ̃'in the airâ € ™ â € ™ the bag via a purge line.

Ultimately, the systems known so far have either the drawback of highlighting a significant contact area between the blood and the air or of presenting a certain degree of inefficiency in the separation and consequent safe evacuation of any air bubbles. collected in the venous line of blood aspiration from the patient.

In addition to the drawbacks described above, the systems of the known type have poor functionality and poor ability to adapt to various types of treatment, therefore the operator having to use a new circuit from time to time in order to adapt to the therapeutic or treatment needs that gradually arise.

In this situation it is an object of the invention to solve one or more of the drawbacks and / or limitations described above.

In particular, one of the objects of the invention is to provide a reservoir and an extracorporeal circuit using this reservoir which are capable of offering greater operational flexibility with respect to known solutions.

Another object of the invention is to provide a technical solution which allows to minimize as far as possible the contact between blood or other blood products and the air.

Another object of the invention is to offer a technical solution capable of allowing the accumulation of relatively large quantities of blood outside the human body during operating phases which, for example, provide for the evacuation from the human body of quantities relevant blood or other biological fluid.

An auxiliary purpose of the invention is to offer a technical solution which allows the efficient filtering of the suction blood coming from the operating field.

A further auxiliary object is to offer a solution in which the patient's venous blood reaches the collection device directly, receiving an appropriate de-foaming action.

A further auxiliary object of the invention is to provide a technical solution capable of suitably treating, for example by means of oxygenation, the blood to be returned to the patient undergoing treatment.

One or more of the aforementioned objects, which will become clearer in the course of the following description, is substantially achieved by a collection device and an extracorporeal circuit using this device, in accordance with one or more of the attached claims.

In a 1st aspect there is a device for collecting biological fluids for medical use comprising: a rigid container internally defining at least a first fixed volume chamber, an auxiliary container having at least a deformable portion defining a second volume chamber inside variable according to the position of the deformable portion, at least one passage capable of placing the first and second chambers in fluid communication, at least one inlet door connected with at least one of said containers and at least one outlet door connected with at least one of said containers.

In a 2nd aspect in accordance with the 1st aspect the rigid container has a box-like conformation having at least one bottom wall, at least one side wall emerging from the bottom wall and at least one closing portion placed at the top of the side wall, said walls defining the volume of the first chamber.

In a 3rd aspect, in accordance with the previous aspect, the device provides at least one ventilation line designed to create a connection between the first chamber and the external environment.

In a 4th aspect in accordance with any of the preceding aspects, the auxiliary container is defined by at least one perimetrically deformable wall integral with at least a corresponding portion of the side wall of the rigid container,

In a 5th aspect in accordance with the 3rd or 4th aspect, the device provides at least one ventilation line designed to create a connection between the first chamber and the external environment and selectively openable-closable by means of an interception organ placed on the same ventilation line.

In a 6th aspect in accordance with any of the preceding aspects, the rigid container and the auxiliary container are mutually side by side.

In a 7th aspect in accordance with any one of the 2nd to 6th aspects, a portion of the side wall of the rigid container acts as a separation wall between the first and second chamber and constitutes a common wall portion between the two rigid containers and auxiliary. -

In an 8th aspect in accordance with any one of the 2nd to 7th aspects, a portion of the side wall of the rigid container emerges, with reference to an operating configuration in which said side wall extends from the bottom upwards, a part developing inferiorly with respect to the first chamber and in extension with respect to the lateral wall.

In a 9th aspect in accordance with the previous aspect, the auxiliary container comprises a rigid wall formed by a portion of the side wall of the rigid container and by said part (14) extending below the first chamber.

In a 10th aspect in accordance with the 8th or 9th aspect, the auxiliary container comprises a flexible wall perimeter tightly fixed on said rigid wall of the auxiliary container.

In an 11th aspect in accordance with the previous aspect the flexible wall is fixed to the rigid wall by welding or gluing.

In a 12th aspect in accordance with any of the aspects from the 8th to the 11th, the part extending below the first chamber has an arched conformation with concavity facing the interior of the second chamber.

In a 13th aspect in accordance with any of the preceding aspects, the passage which places the first and second chambers in fluid communication is located at the bottom of the first chamber.

In a 14th aspect, in accordance with any of the preceding aspects, the device comprises at least one fluid interception element which can be manually activated from the outside by means of a cock or which can be controlled by an actuator member and operates in correspondence with the passage which communicates fluid. the first and second bedroom.

In a 15th aspect in accordance with the previous aspect, the fluid interception element being displaceable between a first operating position in which a passage of fluid is allowed between the first and second chamber and a second operating condition in which the passage of fluid between the first and second chambers is prevented.

In a 16th aspect in accordance with any of the preceding aspects the entry door of the collecting device is situated to allow direct entry to the second chamber.

In a 17th aspect in accordance with any of the 8th to 16th aspects, the entrance door is located in correspondence with the part of the rigid wall of the second chamber extending below the first chamber.

In an 18th aspect in accordance with any of the preceding aspects, the exit door is located in correspondence with the lowest position, with reference to an operating condition of the device, of the second chamber.

In a 19th aspect in accordance with any of the aspects from the 8th to the 18th, the exit door is placed in correspondence with the vertically lowest area of the rigid wall emerging below the first chamber.

In a 20th aspect in accordance with any of the preceding aspects, the inlet and / or outlet port are located, with reference to an operating condition of the device, at a lower height than the passage which places the fluid in communication first with the second bedroom.

In a 21 ° aspect in accordance with any of the 14 ° to 20 ° aspects, the fluid interception element comprises a substantially cylindrical wall element rotatably engaged inside said passage and having an axial end Fluid passage opening placed in communication with the second chamber and also having a fluid passage opening made in correspondence with a lateral wall of the cylindrical surface; following an angular rotation of the fluid interception element, the opening placed on the cylindrical wall can be moved between a condition in which this opening opens towards the first chamber and places said first chamber in fluid communication with the second chamber , and a second position angularly offset with respect to the first position in which the opening placed on the cylindrical side wall is closed by a corresponding part of said passage thus preventing the communication of fluid between the first and the second chamber.

In a 22 ° aspect in accordance with any of the preceding aspects, the device comprises at least one filtering element placed in correspondence with said first chamber and having an access side for receiving fluid to be filtered coming from one or more connectors for the lines suction, and an outlet side capable of supplying filtered fluid towards said bottom wall of the first chamber.

In a 23rd aspect in accordance with any of the preceding aspects, the device comprises an adduction channel fixed to the inlet door, a discharge channel fixed to the outlet door and a bypass channel which has a first end connected to the outlet channel. adduction and a second end connected to the discharge channel to bypass said fluid collection device.

In a 24 ° aspect in accordance with the previous aspect, the device comprises a fluid interception member operating on the bypass channel, an interception member, for example a clamp, of fluid operating on the supply channel in an area between the inlet door and the ends of the bypass channel and an interception device operating on the discharge channel in an area between the outlet door and the other end of the bypass channel.

In a 25 ° aspect in accordance with the previous aspect, each interception element arranged on the supply channel, on the discharge channel and on the bypass channel comprises at least one selected from: an elastic clamp which can be activated manually "between an opening position and a closing position in which the respective portion of pipe on which this clamp operates, a fluid interception valve that can be manually activated by a user, a fluid interception valve that can be activated by an actuator member controlled by a control unit, is closed.

In a 26th aspect in accordance with any of the preceding aspects, the device comprises a connector element, for example of the luer type, placed on an end part of the adduction channel opposite the inlet port; and a connector member, for example of the Luer type placed on the discharge channel opposite the outlet door, said connectors allowing easy engagement and disengagement of the collection device with respect to a respective line of an extracorporeal circuit, said Luer connectors having for example, the following dimensions: 1 / 2â € for device used on adults, 3 / 8â € for pediatric use and 1⁄4â € for neonatal use.

In a 27 ° aspect in accordance with any of the preceding aspects, the device comprises at least one interrupter operatively connected upstream of the inlet door and comprising internally at least one hydrophilic membrane capable of allowing the passage of fluid from a section upstream of the interrupter. towards a downstream section of the same reducing the passage of air, said membrane being arranged inside the ampoule separating the latter into an upstream half-chamber and a downstream half-chamber, in correspondence with the upstream half-chamber being provided a gas evacuation passage.

In a 28 ° aspect in accordance with any of the 8 ° to 27 ° aspects, the back wall of the first chamber is inclined from top to bottom as it approaches the second chamber, so that the fluid outflow through the connecting passage from the first to the second chamber.

In a 29 ° there is an extracorporeal circuit for the treatment of blood comprising: at least one blood collection line having a first end that can be connected to at least one access to the patient and at least a second end placed in fluid communication with the inlet port to the collection device, at least one blood return line having a first end connected to the exit door from the collection device and at least a second end connectable to an access to the patient's cardiovascular system, at least one collection device interposed between the collection device pickup and return line; said collection device being of the type according to any of the preceding aspects.

In a 30 ° aspect in accordance with the previous aspect, the circuit comprises at least one blood oxygenation unit located downstream of the collection device, in correspondence with the blood return line to the patient.

In a 31st aspect in accordance with the 29th or 30th aspect, the circuit comprises a pump provided in correspondence with said return line, optionally in correspondence with a section of the return line comprised between the and

In a 32 ° aspect in accordance with the previous aspect the pump comprising a centrifugal pump or a pump of the peristaltic type, for example with rollers.

In a 33rd aspect in accordance with any one of the 29th to 32nd aspects, the circuit comprises a filter placed on said return line downstream of said oxygenator.

In a 34 ° aspect in accordance with any one of the 29 ° to 33 ° aspects the circuit comprises an air bubble separator, placed in correspondence with said return line.

In a 35 ° aspect in accordance with any one of the 29 ° to 34 ° aspects the circuit comprises an air bubble detector arranged on said return line at or downstream of the air bubble separator.

In a 36th aspect there is a procedure for using a device in accordance with any of the aspects from the 1st to the 28th, said procedure for use providing a bypass mode in which the device is excluded from the circuit extracorporeal as the interception organs on the adduction channel and on the discharge channel are closed while the organ on the bypass channel is open: in this mode the blood can be oxygenated, for example, without however using any fluid present in one or the other of the two containers which are therefore excluded from the circuit.

In a 37th aspect there is a procedure for using a device in accordance with any of the aspects from the 1st to the 28th, said procedure for use providing a mode in which the device is active and the The interception element is closed: in this case the interception elements on the supply channel and on the discharge channel are open while the element on the bypass channel is closed; in this operating mode, the extracorporeal circuit exclusively exploits the volume of the deformable container, operating in fact as a closed circuit substantially without - or with minimal - contact with the air; the fluid withdrawn from the patient proceeds into the venous branch, enters the container through the entrance door, exits the door, reaches the pump, passes through the oxygenator and any other units and then returns to the patient through the second end of the return line; when emptying the container where the blood accumulates, the deformable portion of the container rests on the internal surface of the part, closing the exit door; in this regard it should be noted that a tab or other gripping element emerging from the deformable portion may be provided which can be used to facilitate the separation of the deformable portion from the part.

In a 38th aspect there is a procedure for using a device in accordance with any of the aspects from the 1st to the 28th, said procedure for use providing a mode in which the device and the shut-off element are open; also in this case the parts on the adduction channel and on the exhaust channel are open while the part on the bypass channel is closed; in this operating mode, the extracorporeal circuit exploits both the volume of the deformable container and that of the rigid container, effectively operating as an open system with a high capacity for accumulating blood or other fluid - note that in this case the rigid container can receive the blood coming from the operating field and as such comprising clots, bone and tissue fragments, fat and more which can be adequately filtered by the filter present in the rigid container; also in this case the fluid withdrawn from the patient proceeds in the venous branch, accesses the container and also the container since the two containers are connected by the passage. The blood then flows out of the door, reaches the pump, passes through the oxygenator and any other units and then returns to the patient through the second end of the return line; as mentioned, it is possible to provide that the container also receives blood or other fluid through connectors for the suction, infusion or arteriovenous recirculation lines. In this operating mode, however, the fluid level in the containers is practically the same as the two containers are connected. Obviously, in case of need, the operator can disconnect the communication between the two containers simply by acting on the interception element.

In a 39th aspect a device for collecting biological fluids for medical use is provided comprising: at least one container selected from the group comprising a rigid container internally defining at least a first fixed volume chamber and an auxiliary container having at least one deformable portion defining the inside a second chamber of variable volume according to the position of the deformable portion, at least one inlet door connected with at least one said container, at least one outlet door connected with at least one said container, an adduction channel connected with the inlet door , a discharge channel connected to the outlet port, a bypass channel which has a first end connected to the supply channel and a second end connected to the discharge channel to bypass said fluid collection device (1), a fluid interception member operating on the bypass channel and at least one of a fluid interception member operating on the supply channel and an interception member operating on the discharge channel.

In a 40 ° aspect in accordance with the previous aspect, the device comprises a rigid container internally defining at least a first fixed volume chamber and an auxiliary container having at least one deformable portion defining inside it a second chamber of variable volume according to the position of the deformable portion, optionally in which said deformable container comprises a bag.

In a 41st aspect in accordance with the 39th or 40th aspect, the device comprises at least one passage capable of placing the first and second chambers in fluid communication.

In a 42nd aspect in accordance with any one of the foregoing aspects each container comprises a respective inlet door and a respective outlet door, or wherein only the auxiliary container comprises both the inlet door and the outlet door.

In a 43 ° aspect in accordance with any of the aspects from 40 ° to 42 ° the rigid container has a box-like conformation having at least one bottom wall, at least one side wall emerging from the bottom wall and at least a closing portion placed at the top of the lateral wall, said walls defining the volume of the first chamber.

In a 44 ° aspect in accordance with any of the preceding aspects, the device provides at least one ventilation line designed to create a connection between the first chamber and the external environment.

In a 45 ° aspect in accordance with any of the aspects from 39 ° to 44 ° the auxiliary container is defined by at least one perimetrically deformable portion integral with at least a corresponding portion of the side wall of the rigid container,

In a 46 ° aspect in accordance with any one of the 39 ° to 45 ° aspects the rigid container and the auxiliary container are mutually side by side.

In a 47 ° aspect in accordance with any one of the 43 ° to 46 ° aspects, a portion of the side wall of the rigid container acts as a separating wall between the first and second chambers and constitutes a common wall portion between the two rigid containers and auxiliary or the auxiliary container comprises a respective bag integrally connected with the rigid container.

In a 48 ° aspect in accordance with any of the aspects from 43 ° to 47 ° a portion of the side wall of the rigid container emerges, with reference to an operating configuration in which said side wall extends from the bottom upwards, a part developing inferiorly with respect to the first chamber and in extension with respect to the lateral wall.

In a 49 ° aspect in accordance with the preceding aspect, the auxiliary container comprises a rigid wall formed by a portion of the side wall of the rigid container and by said part extending below the first chamber and a flexible wall perimetrically fixed on said rigid wall of the auxiliary container.

In a 50th aspect in accordance with the 48th or 49th aspect, the rigid part extending below the first chamber has an arched conformation with a concavity facing towards the interior of the second chamber.

In a 51 ° aspect in accordance with any one of the 39 ° to 50 ° aspects, the passage which places the first and second chambers in fluid communication is placed at the bottom of the first chamber.

In a 52 ° aspect in accordance with any of the aspects from 39 ° to 51 ° the back wall of the first chamber is inclined from top to bottom as it approaches the second chamber, so that the outflow of fluid through the connecting passage from the first to the second chamber.

In a 53 ° aspect in accordance with any of the aspects from 39 ° to 52 °, the device comprises at least one fluid interception element which can be manually activated from the outside by means of a tap or which can be controlled by means of an actuator member and operating at the passage which places the first and second chambers in fluid communication.

In a 54 ° aspect in accordance with the previous aspect, the fluid interception element can be moved between a first operating position in which a passage of fluid is allowed between the first and second chamber and a second operating condition in which the passage of fluid between the first and second chambers is prevented.

In a 55 ° aspect in accordance with the 53 ° or 54 ° aspect, the fluid interception element comprises a substantially cylindrical wall element rotatably engaged inside said passage and having an opening at one of its axial ends fluid passage placed in communication with the first and / or second chamber and also having a fluid passage opening made in correspondence with a lateral wall of the cylindrical surface; following an angular rotation of the fluid interception element, the opening placed on the cylindrical wall can be moved between a condition in which this opening opens and places said first chamber in fluid communication with the second chamber, and a second position angularly offset with respect to the first position in which the opening placed on the cylindrical side wall is closed by a corresponding part of said passage thus preventing the communication of fluid between the first and the second chamber.

In a 56 ° aspect in accordance with any of the aspects from 48 ° to 55 ° the entrance door is located at the rigid part extending below the first chamber and the exit door is located at the lowest position, with reference to an operating condition of the device, of the second chamber.

In a 57 ° aspect in accordance with any of the aspects from 48 ° to 56 ° the exit door is located in correspondence with the vertically lowest area of the rigid part.

In a 58 ° aspect in accordance with any of the aspects from 39 ° to 57 °, the entrance and / or exit door are located, with reference to an operating condition of the device, at a lower height than the passage that places in fluid communication the first with the second chamber.

In a 59 ° aspect in accordance with any one of the 39 ° to 58 ° aspects, the rigid container comprises at least one filter element placed in correspondence with said first chamber and having an access side for receiving fluid to be filtered coming from connectors for the lines suction side, and an outlet side capable of supplying filtered fluid towards said bottom wall of the first chamber.

In a 60 ° aspect in accordance with any one of the 39 ° to 59 ° aspects, the supply channel comprises at least a first channel which places the supply channel in fluid communication with the inlet port of the rigid container, and at least a second channel which places said supply channel in fluid communication with at least the outlet port of the rigid container.

In a 61 ° aspect in accordance with any one of the 39 ° to 60 ° aspects the supply channel comprises at least a third channel which places the supply channel in fluid communication with at least the inlet port of the auxiliary container, and at least one fourth channel which places said supply channel in fluid communication with at least the outlet port of the auxiliary container.

In a 62 ° aspect in accordance with the previous aspect, an interception organ operates on the first channel, on the second channel and / or on a section of the adduction channel that connects the first with the second channel and / or in which an organ of interception works on the third channel, on the fourth channel and / or on a section of the adduction channel that connects the third with the fourth channel.

In a 63 ° aspect in accordance with any of the aspects from 60 ° to 62 ° the first end of the bypass channel is connected upstream of the interception device applied on the first channel.

In a 64 ° aspect in accordance with any of the aspects from 61 ° to 63 ° the second end of the bypass channel is connected downstream of the interception organ applied on the second channel.

In a 65 ° aspect in accordance with any one of the 61 ° to 64 ° aspects the second end of the bypass channel is connected downstream of the fourth channel.

In a 66 ° aspect an extracorporeal circuit is provided for the treatment of blood comprising: at least one blood collection line having a first end that can be connected to at least one access to the patient and at least a second end placed in fluid communication with at least one port at least one blood return line having a first end connected to at least one exit door from the device and at least a second end connectable to an access to the patient's cardiovascular system, at least one collection device interposed between the withdrawal and the return line, said collection device being of the type according to any one of the aspects from 39 ° to 65 °.

In a 67 ° aspect in accordance with the previous aspect, the circuit comprises at least one blood oxygenation unit located downstream of the collection device, in correspondence with the blood return line to the patient.

In a 68 ° aspect in accordance with the previous aspect, the said oxygenation device comprises a semipermeable membrane separating the oxygenation device in a first chamber in which the blood coming from the collection device flows and in a second separate chamber through said membrane from the first chamber in which an oxygenating fluid flows towards the blood.

In a 69 ° aspect in accordance with any of the 66 ° to 68 ° aspects a pump is provided at said return line.

In a 70 ° aspect in accordance with the previous aspect, the pump is arranged in correspondence with a section of the return line between the collection device and the oxygenator.

In a 71st aspect in accordance with the 69th or 70th aspect the pump comprises a centrifugal pump or a pump of the peristaltic type, for example with rollers.

In a 72 ° aspect in accordance with any one of the 66 ° to 71 ° aspects the circuit comprises a filter placed on said return line downstream of said oxygenator.

In a 73 ° aspect in accordance with any one of the aspects from 66 ° to 72 ° the circuit comprises an air bubble separator, also placed in correspondence with said return line.

In a 74 ° aspect in accordance with any one of the 66 ° to 73 ° aspects the circuit comprises an air bubble detector present on said return line at or downstream of the air bubble separator.

In a 75th aspect a procedure for using a device is provided in accordance with any of the aspects from 39 ° to 65 °, said use procedure providing for a bypass mode, in which the device is excluded from the extracorporeal circuit as the organs arranged on the adduction channel and / or on the discharge channel are closed while the interception organ arranged on the bypass channel is open: in this mode the blood can be oxygenated, for example, without however use of any fluid present in one or the other of the two containers which are therefore excluded from the circuit.

In a 76 ° aspect, a procedure for using a device is provided in accordance with any of the aspects from 39 ° to 65 °, said procedure for use providing a mode with device 1 active and use of the auxiliary container: in this case at least a part of the interception members arranged on the supply channel are open while the interception member arranged on the bypass channel is closed; in this operating mode, the extracorporeal circuit exclusively exploits the volume of the auxiliary container, operating in fact as a closed circuit substantially without or with minimal contact with the air; the fluid withdrawn from the patient proceeds in the venous branch, enters the container through the inlet port 6 in communication with the third channel, leaves the port in fluid communication with the fourth channel, reaches the pump, crosses the oxygenator and any other unit and then return to the patient via the second end of the return line.

In a 77 ° aspect, a procedure for using a device is provided in accordance with any of the aspects from 39 ° to 65 °, said procedure for use providing a mode with device 1 active and use of the rigid container: in this case at least a part of the interception members arranged on the supply channel are open while the interception member arranged on the bypass channel is closed; in this operating mode, the extracorporeal circuit exclusively exploits the volume of the container, operating in fact as an open circuit; the fluid withdrawn from the patient proceeds in the venous branch, enters the container through the inlet port in communication with the first channel, exits the port in fluid communication with the second channel, reaches the pump, crosses the oxygenator and any other units then return to the patient through the second end of the return line.

In a 78 ° aspect there is a procedure for using a device in accordance with any of the aspects from 39 ° to 65 °, said procedure for use providing a mode with device 1 active and use of both the rigid container both of the auxiliary container: also in this case at least one of the interception elements arranged on the supply channel is open while the interception element arranged on the bypass channel is closed; the device is equipped with the passage, it is possible to close the second and third channel and the channels that connect the first with the second channel and the channel that connects the third with the fourth channel while maintaining a condition of opening the first and fourth channels as well as the interception element placed on the passage that connects the two containers; in this operating mode, the extracorporeal circuit exploits the volume of the deformable container and that of the rigid container, operating in fact as a hybrid circuit with high capacity for accumulating blood or other fluid - note that in this case the rigid container can receive from the opening of blood coming from the operating field and as such comprising clots, bone powders and the like which can be adequately filtered by the filter present in the rigid container; also in this case the fluid withdrawn from the patient proceeds in the venous branch, accesses the container and also the container as the two containers are connected. The blood then escapes from the port of the auxiliary container, reaches the pump, passes through the oxygenator and any other units and then returns to the patient through the second end of the return line; as mentioned it is possible to foresee that the container also receives blood or other fluid through the opening. In this operating mode, however, the fluid level in the containers is practically the same as the two containers are connected.

The collection tank can be made in different sizes depending on the use in adult, pediatric or neonatal patients,

Further characteristics and advantages will become clearer from the detailed description of some embodiments provided by way of example, and therefore not limitative of aspects of the invention. These embodiments are described below with reference to the accompanying drawings, which must also be understood as examples and not limitations of the invention, in which:

Figure 1 shows a biological fluid collection device in accordance with aspects of the invention in a side elevation view;

Figure 1A shows a detail of the device of Figure 1;

Figure 2 shows the collection device of Figure 1, in a top plan view;

Figure 3 shows, in perspective view, a detail of the device of

Figure 4 illustrates a section of the collection device of Figure 1;

Figure 5 shows a detail of Figure 4 relating to a tap for opening and closing the passage which places a first and a second chamber of the device in fluid communication in accordance with aspects of the invention;

Figure 6 also shows a detail of the tap of the previous figure in a condition of interception of the fluid;

- Figure 7 is an exploded view of the biological fluid collection device of Figure 1;

Figure 8 illustrates an extracorporeal circuit in which the device of Figure 1 is inserted in a first operating condition in which the bypass line of the device is closed;

- Figure 9 shows an extracorporeal blood circuit in which the device of figure 1 is inserted in a second operating condition in which the bypass line of the device is open, while the adduction and fluid return channels respectively entering are closed and outgoing from the collection device;

Figures 10A, 10B, 10C and 10D show an extracorporeal blood circuit in accordance with aspects of the invention.

With reference to the accompanying figures, 1 indicates as a whole a device for collecting biological fluids for medical use. Device 1 can be used for the most varied methods of extracorporeal circulation. As will be better described below, the exclusion, even temporary, of the device or tank 1, by activating the bypass line associated with it, â € ”creates an â € œactive venous drainageâ € which allows the execution of various methods such as ECLS (extra coreporeal fife support), ECMO (extra corporeal membrane oxygenator) type cardiorespiratory assistance, intra-operative ECMO type. The device can also be used for treatments where it is necessary to accumulate blood, blood products and / or fluids re-enter or enter the patient undergoing treatment.

As shown in figures 1 and 4, the collection device 1 comprises a rigid container 2 flanked by an auxiliary container 3. The rigid container 2 comprises a bottom wall 8 which in the illustrated example is inclined from the other towards the bottom proceeding towards the auxiliary container 3 and a side wall 9 emerging substantially vertically, or with a certain flaring, from the bottom wall 8. A closing portion 10 or end wall is then applied to the top of the side wall 9 which in operating conditions it develops substantially in a transverse direction to the side wall. More in detail, the closure portion 10 is a plug connected to the top of the side wall 9 of the rigid container 2. As shown in Figure 2, the closure portion 10 includes, but is not limited to, one or more access elements i which are configured to put the rigid container 2 and / or the auxiliary container 3 in communication with the external environment. More in detail, the closure portion 10 comprises various connectors globally indicated with 20 including: at least one connector, for example 3 / 8â €, for a filtered auxiliary input line which allows the introduction of filtered blood into the rigid container 2; a plurality of 1 / 4â € connectors (in the example of figure 2 at least four) for connection with filtered inlet lines that can be used for connection to suction lines, not shown, designed to receive blood from the operating field (this blood needs filtering before being reintroduced into the patient's cardiovascular system) or for the connection of arteriovenous recirculation lines. The closing portion 10 can also comprise a three-way tap 20a designed to put the auxiliary container 3 in air communication with the environment.

The closing portion 10 can also be equipped with a vertical inlet for the infusion of priming liquid, various Luer Locks equipped with screw caps, a ramp for sampling, a Luer connector connected through a straw (not shown ), to the lower part of the reservoir for external withdrawal of cardiotomy blood, by aspiration.

By detailing the structure of the rigid container, the bottom wall 8, the side wall 9 and the closing portion 10 define a first chamber 2a inside the rigid container 2 of predetermined volume. For example, the volume of the first chamber can vary, in the case of an â € œadultâ € device, in a range between 250 and 3000 cm <3>, for pediatric and neonatal sizes, the volume is proportionally reduced.

In a position immediately adjacent to the rigid container 2 is the auxiliary container 3 which in the example of Figure 1 comprises at least a deformable portion 4, in the case of Figure 1 defined by a flexible wall, which helps to define a second chamber 3a having a variable volume according to the configuration of the deformable portion. The volume range of chamber 3 a is also reduced in pediatric and neonatal sizes.

From the constructive point of view, it is possible to provide that the auxiliary container 3 is made of a bag entirely formed by flexible walls closed on themselves so as to define a second deformable chamber, or alternatively the auxiliary container 3 can comprise a fixed flexible wall to one or more rigid walls. In the example illustrated in figures 1 and 4, the auxiliary container 3 is made as follows: the flexible wall is tightly fixed at its perimeter edge to one or more of the rigid walls of the rigid container 2. In this case the The flexible wall is fixed to a portion of the side wall 9 of the rigid container 2. This portion of the side wall 9 of the rigid container 2 therefore becomes a partition partition in common between the rigid container 2 and the auxiliary container and separating the former from each other. and the second chamber 2a, 3 a. This separation partition between the first and second chamber is concave, on the side facing the auxiliary container, and acts as a rigid support for the flexible wall which can have the same shape and the same dimensions as the separation partition.

Alternatively, as already mentioned, it is possible to provide that the auxiliary container 3 is defined by a deformable bag fixed adjacent to the rigid container 2. In any case, the collection device 1 comprises at least one passage 5 which places the first in fluid communication with the second chamber 2a, 3 a. In correspondence with this passage 5 there is a fluid interception element 15, for example equipped with a tap that can be activated from the outside or connected to an actuator member managed by a control unit, which is able to open and selectively close the fluid passage between the first and second chambers 2a, 3a. As can be seen in the detail shown in Figures 4, 5 and 6, the fluid interception element 15 substantially comprises a wall element 16, which can for example comprise a tap operating a cylindrical tubular shape selector, having an opening terminal 17a facing into the second chamber 3a and a passage opening 17 developed on the lateral wall of the cylindrical surface of the selector. Depending on the angular position imposed on the selector by the activation tap, the passage opening 17 on the side wall can open and face the first chamber 2a, thus placing the first and second chambers 2a, 3a in fluid communication (condition shown in figure 5), or it can vice versa face a bottom portion of the rigid container 2 which therefore acts to close this opening. In other words, the angular rotation of the tap causes an angular rotation of the cylindrical selector which thus moves between a position of communication of fluid between the first and second chambers 2a, 3a and a position of interdiction of such communication of fluid. .

With reference to figures 4, 5, 6 and 7, the collection device 1 comprises at least an inlet door 6 for example connected to the second chamber 3a and an outlet door 7, also for example connected to the second chamber 3a. In particular, the device comprises a further rigid part 14 emerging downwards, for example in continuation of the side wall 9 of the rigid container 2 and defining, with the same portion of the side wall 9 of the rigid container 2, one of the two half-parts which define the auxiliary container 3, the second half being formed by the flexible wall which is fixed to the rigid half by sealing the perimeter edges of the flexible wall onto the rigid portion, as already described. As can be seen in the accompanying figures, the inlet door 6 and the outlet door 7 of the device 1 are made in correspondence with the aforementioned rigid part 14 extending in continuation of the side wall 9 of the rigid container 2 below the first chamber 2a. More precisely, the outlet port 7 is located in the vertically lower zone of the second chamber 3a, while the inlet port 6 is located below the fluid communication passage 5 between the first and second chambers 2a, 3a , but above the exit port 7.

As illustrated in Figure 4, the rigid part extending below the first chamber 2a has an arched conformation so as to facilitate the outflow of fluid from the inlet port 6 to the outlet port 7 or in any case, more generally, the outflow of fluid towards the exit door 7. Furthermore, the arched conformation of the part 14, together with the concavity of the same facing towards the inside of the second chamber 3 a facilitate, when emptying the same second chamber, the support of the deformable portion 4 on the internal surface of the part 14. The deformable wall or membrane 4 adheres perfectly to the outlet hole so that in the event of a decrease in the liquid level, it collapses on the rigid support and, therefore, on the outlet hole, preventing the accidental entry of air into the circuit extracorporeal. Near the outlet hole, the outside of the membrane 4 is provided with a silicone tab 4a which allows the membrane to be pulled out, eliminating its collapse. In correspondence with the outlet port 7 there is a discharge channel 23 , fixed to the outlet door 7 itself, while in correspondence with the inlet door 6 there is a supply channel 22 fixed to the same inlet door 6. Transversely to the supply channel 22 from the discharge channel 23 there is a channel for bypass 24 having a first end 24a connected to the supply channel 22 and a second end 24b opposite said first end 24a and connected to the discharge channel 23. In the portion of discharge channel 23 between the outlet port 7 and the second end 24b of the bypass channel 24, in the section of the adduction channel 22 between the opening of the inlet 6 and the first end 24a of the bypass channel 24, as well as in c or correspondence of the bypass channel 24, the presence of a respective fluid interception member can be provided. In particular, the accompanying figures show, in a non-limiting way, a condition in which interception members 25, 26, 27 are respectively present in the bypass channel, in the supply channel and in the discharge channel.

These interception devices, in the example illustrated in the accompanying figures, comprise a clip that can be activated manually between a clamping condition of the tube in which the passage of fluid in the respective section is forbidden and a release condition in which the passage of fluid through the tube can be converted. By selectively operating the three clamps present on said pipe sections, it is possible to achieve different operating conditions of the collection device, as will be better explained below.

As an alternative to the clamping devices described, fluid interception devices of a different nature can be used, for example manually controlled valves, or alternatively interception valves controlled by actuator elements managed by a control unit.

In accordance with one aspect of the invention, the channels 22, 23 and 24 can be preformed in a single piece or pre-assembled (for example glued or welded) to each other and one or the other of the containers 2 and 3.

As can be seen from Figure 1, the device 1 can also comprise at least one interrupter 30 operatively connected upstream of the inlet port 6 and comprising internally at least one hydrophilic membrane capable of allowing the passage of liquid from a section upstream of the interrupter 30 towards - a section downstream of the same reducing the passage of gas (thus acting as a de-foaming membrane). As can be seen from the accompanying figures, the ampoule 30 is arranged, in a non-limiting way, on the adduction channel 22 to intercept the fluid directed to said containers and passing through the inlet port 6. As regards the membrane arranged at the Inside the bulb 30, it separates the upstream section from the downstream section respectively in an upstream half-chamber 30a and in a downstream half-chamber 30b. In particular, the upstream half chamber 30a includes, but is not limited to, a passage 31 useful for the evacuation of gas.

Figure 1A shows a detail of the ampoule which is inserted engaged in the adduction channel 22 between two Luer connections 22a and 22b (large, for example 1/2 inch). It should be noted that for example the interrupter 30 can operate in a section interposed between the entrance to the chamber 3a and the junction between the channel 22 and the bypass channel 24.

Both the supply channel 22 and the discharge channel 23, in correspondence with respective opposite ends to the inlet and outlet ports 6, 7, comprise connector elements 28, 29 of removable engagement, for example connectors of the large luer type ( 1 / 2â € for the adult reservoir, 3 / 8â € for the pediatric device and 1⁄4â € for the neonatal device) for the removable coupling of the collection device 1 in an extracorporeal circuit 100, as shown in figure 1.

These Luer connectors, being connected to the device through the interposition of a clampable (welded) tube, make it easier to change the device in the event of its malfunction.

Finally, the collection device 1 comprises a filtering element 18 located in correspondence with the upper zone of the first chamber 2a and having an access side 19 placed in fluid communication with an inlet for the fluid to be filtered and an outlet side 21 for the filtered fluid. facing the lower zone of the first chamber 2a to supply filtered fluid.

More in detail, the filter element 18 is configured to receive through the access side the fluid introduced into the first chamber 2a through the auxiliary inlet opening 20 and to supply filtered fluid from said outlet side 21.

As can be seen in Figures 8 and 9, the collection device 1 can be inserted into the extracorporeal blood circuit 100 which has a collection line 32 and a blood return line 36 to the patient; in practice, the collection device 1 is inserted so as to connect the connector 28 of the supply channel 22 to a second end 35 of the collection line 32, also connecting the connector 29 associated with the discharge channel 23 to a first end 37 of the return line 36. In this way, the collection line 32 can receive the venous blood and send it towards one or both chambers of the collection device 1 while the return line 36 can return the blood flowing out of the collection device 1 towards the patient. In the example illustrated in Figures 8 and 9, the sampling line has two branches 32a, 32b for drawing blood from the patient, respectively connected to accesses 34 (for example connected to the superior and inferior vena cava).

It should be noted that, for example, a treatment unit is provided on the return line 36, for example an oxygenation device 40 operating in order to provide adequate oxygenation to the blood to be returned to the patient. The oxygenating device can include various types of membrane: microporous, polymethylpentene, etc.

Additional treatment units can be provided such as a heat exchanger (for example integrated in the oxygenator 40), a filter 43, an air bubble separator 44, an air bubble detector 45 and others unit still depending on the type of treatment to be carried out on the blood.

In more detail, the units described above are arranged on the blood return line 36. In particular, as can be seen from the accompanying figures, the oxygenation device 40 is arranged downstream of the collection device 1. Downstream of the oxygenation device, the filter 43, the air bubble separator 44 and the air bubble detector 45 are arranged in a non-limiting way.

The collection device 1 can also comprise a control unit 46 connected to at least one of the units mentioned above and configured to control and manage at least one of said units.

The control unit 46 is also configured to receive a control signal from the air bubble detection unit 45 and possibly control at least one interception unit 47 arranged downstream of the air bubbles in such a way as to prevent any entry of air bubbles into the patient.

In order to move the blood along the return line 36 and in fact along the entire extracorporeal circuit, a pump 42 can be provided located downstream of the collection device 1 and operating for example in a section of the return line 36 of the blood to the patient between the oxygenator 40 and the outlet port 7 of the collection device 1. From the manufacturing point of view, the pump 42 can be a peristaltic type pump (roller), a centrifugal pump with a pump of another type, as long as it is able to move without

A variant of the invention is shown in figures 10A-10D. In particular, the device 1 comprises in this case at least one rigid container 2 and at least one auxiliary container 3, which can provide, without limitation, the same characteristics of the containers described above. At least one of the containers comprises at least an entrance door 6 and an exit door 7; in particular, as shown in Figures 10A to 10D, the device 1 each container comprises a respective inlet port 6 and a respective outlet port 7. The device 1 comprises a supply channel 22 in fluid communication with the sampling line 32 suitable for taking blood from the patient. The supply channel 22 comprises at least a first channel 22a and at least a second channel 22b which place the supply channel 22 in fluid communication with the rigid container 2. More in detail, the first channel 22a emerges transversely to the supply channel and it connects to the inlet port 6 of the rigid container 2. The second channel 22b also emerges from the supply channel 22 and connects to the outlet port 7 of the rigid container 2. As can be seen from the accompanying figures, the supply channel can also optionally comprising a section 22c which places the first and second channels 22a, 22b in fluid communication. A respective shut-off member 26a, 26b can operate on the first and second channels 22a, 22b and be configured to selectively position itself in a condition of passage or interdiction of the passage of fluid through the channel on which the shut-off member is applied. .

The supply channel 22 can also comprise a third and a fourth channel 22d, 22e which place the supply channel 22 in fluid communication with the auxiliary container 3. More in detail, the third channel 22d emerges transversely to the supply channel 22 and connects to the inlet port 6 of the auxiliary container 3. The fourth channel 22e also emerges from the adduction channel 22 and connects to the outlet port 7 of the auxiliary container 2.

As can be seen from the accompanying figures, the adduction channel can optionally also comprise a section 22f which places the third and fourth channels 22d, 22e in fluid communication. A respective interception member 26d, 26e operates on the third and fourth channels 22d, 22e and is configured to selectively position itself in a condition of passage or prohibition of the passage of fluid through the channel on which the interception member is applied. Downstream of the channels 22a, 22b, 22d, 22e, and in continuation of the adduction channel 22 there is a discharge channel 23 which carries the fluid to the return line 36 where the same components can operate (pump, exchanger, oxygenator, bubble trap or arterial filter) described with reference to the solution of Figures 1-8.

A by-pass channel 24 allows to connect the supply channel 22 directly with the discharge channel 23 bypassing the containers 2 and 3, as shown in Figures 10A-10D. In particular, the by-pass channel 24 has a first end 24a connected to the supply channel 22 upstream of the first channel 22a and a second end 24b connected to the discharge channel 23 downstream of the fourth channel 22e. In a further variant the containers 2 and 3 can be connected by a passage 5 on which an interception element 15 can operate: in this case the channels 22b, 22c, 22f and 22d may not be necessary since, being the two containers 2 and 3 connected by passage 5 and equipped with at least one input channel and one output channel, the device would in any case be able to exploit the capacity of both containers 2 and 3.

After what has been described in substantially structural terms, the operation of the device 1 and of the extracorporeal circuit 100 illustrated in Figures 1 to 8 is as follows.

After having connected the device 1 to the rest of the extracorporeal circuit, it is possible to proceed with the washing or â € œprimingâ € operations using, for example, the container 2 into which â € œprimingâ € fluid such as saline can be flowed. Once the â € œprimingâ € is completed, the circuit 100 can be connected to the patient and, by acting appropriately on the organs 25, 26 and 27, select one of the following modes:

- Bypass mode, in which device 1 is excluded from the extracorporeal circuit as organs 26 and 27 are closed while organ 25 is open. In this mode the blood can be oxygenated, for example, without however using any fluid present in one or the other of the two containers 2,3 which are therefore excluded from the circuit 100;

- Mode with device 1 active and shut-off element 15 closed:

in this case the organs 26 and 27 are open while the organ 25 is closed; in this operating mode, the extracorporeal circuit exclusively exploits the volume of the deformable container 3, operating in fact as a closed circuit substantially devoid of - or with minimal - contact with the air; the fluid withdrawn from the patient proceeds in the venous branch, enters the container 3 through the inlet port 6, exits through the port 7, reaches the pump 42, passes through the oxygenator 40 and any other units and then returns to the patient through the second end 38 of the return line; when emptying the - container 3 where the blood accumulates, the deformable portion -4 of the container 3 rests on the internal surface of the part 14, closing the exit door 7; in this regard it should be noted that a tab or other gripping element 4a emerging from the deformable portion 4 can be provided which can be used to facilitate the separation of the deformable portion from the part 14;

- Mode with device 1 active and tap open: also in this case the organs 26 and 27 are open while the organ 25 is closed; in this operating mode, the extracorporeal circuit exploits both the volume of the deformable container 3 and that of the rigid container 2, actually operating as an open system with a high capacity for accumulating blood or other fluid - it should be noted that in this case the rigid container can receive the blood coming from the operating field and as such comprising clots, bone and tissue fragments, fat and the like which can be adequately filtered by the filter present in the rigid container 2; also in this case the fluid withdrawn from the patient proceeds in the venous branch, accesses the container 3 and also the container 2 as the two containers are connected by the passage 5. The blood then flows out of the port 7, reaches the pump 42, passes through the oxygenator 40 and any other units to then return to the patient through the second end 38 of the return line; as mentioned, it is possible to provide that the container 2 also receives blood or other fluid through connectors for the suction, infusion or venous air recirculation lines. In this operating mode, however, the fluid level in containers 2 and 3 is practically the same as the two containers are connected. Obviously, in case of need, the operator can disconnect the communication between the two containers simply by acting on the interception element 15. Finally, it should be noted that the device and the circuit described can be used sequentially in the ways described. For example, it is possible, after priming, to start in the operating mode with device 1 active and shut-off element 15 closed. In this operating mode it is however possible to accumulate any blood coming from the operating field in the container 2. In a subsequent phase, for example, it is possible to switch to the operating mode with device 1 active and interception element 15 open, thus allowing the blood present to flow out. in the container 2 towards the container 3 and then towards the return line. More generally, by acting on the interception element 15 and on the members 25, 26, 27 it is possible to carry out any temporally sequential combination of the operating modes described above,

The operation of the device 1 and of the extracorporeal circuit 100 illustrated in Figures 10A to 10D is as follows.

After having connected the device 1 to the rest of the extracorporeal circuit 100, it is possible to proceed with the washing or â € œprimingâ € operations using, for example, the container 2 and / or the container 3 into which the â € œprimingâ € fluid can be flowed. Once the â € œprimingâ € is completed, it is possible to proceed with the connection of the circuit 100 to the patient and, by acting appropriately on the interception devices arranged on the adduction, discharge and bypass channels, select one of the following modes:

- Bypass mode, in which the device 1 is excluded from the extracorporeal circuit since the organs arranged on the adduction channel and / or on the exhaust channel are closed while the interception device arranged on the bypass channel is open. In this mode the blood can be oxygenated, for example, without however using any fluid present in one or the other of the two containers 2, 3 which are therefore excluded from the circuit 100.

- Mode with device 1 active and use of the auxiliary container 3: in this case at least part of the interception devices arranged on the supply channel are open while the interception device arranged on the bypass channel is closed; in more detail, the interception members 26a, 26b are closed while the interception members 26c, 26d, 26e and 26f are open; in this operating mode, the extracorporeal circuit exclusively exploits the volume of the auxiliary container 3, operating in fact as a closed circuit substantially without or with minimal contact with the air; the fluid withdrawn from the patient proceeds in the venous branch, enters the container 3 through the inlet port 6 in communication with the channel 22d, exits from the port 7 in fluid communication with the channel 22e, reaches the pump 42, passes through the oxygenator 40 and any other units to then return to the patient through the second end 38 of the return line;

- Mode with device 1 active and use of rigid container 2: in this case at least part of the interception devices arranged on the supply channel are open while the interception device arranged on the bypass channel is closed; in more detail, the interception members 26d, 26e are closed while the interception members 26a, 26b, 26f (and optionally 22c) are open; in this operating mode, the extra-bodily circuit exclusively exploits the volume of the container 2, operating in fact as an open circuit; the fluid withdrawn from the patient proceeds in the venous branch, enters the container 2 through the inlet port 6 in communication with the channel 22a, exits from the port 7 in fluid communication with the channel 22b, reaches the pump 42, passes through the oxygenator 40 and any other units to then return to the patient through the second end 38 of the return line;

- Mode with device 1 active and use of both the rigid container 2 and the auxiliary container 3: also in this case at least one of the interception elements arranged on the supply channel is open while the interception element arranged on the bypass channel à Closed; in more detail, in order to exploit the volume of the two containers it is possible to keep the interception members 26a, 26b, 26d and 26e open while the interception members 26c, and 26f can be closed; alternatively, if the device is equipped with passage 5, it is possible to close the channels 22b, 22c, 22d and 22f and keep the interception elements 26a and 26e as well as the interception element in an open condition 15 arranged on the passage connecting the two containers; in this operating mode, the extracorporeal circuit exploits the volume of the deformable container 3 and that of the rigid container 2, operating in fact as an open system with a high capacity for accumulating blood or other fluid - it should be noted that in this case the rigid container can receive connectors for blood suction lines coming from the operating field and as such comprising clots,

filter present in the rigid container 2; also in this case the fluid withdrawn from the patient proceeds in the venous branch, accesses the container 3 and also, possibly, the container 2 as the two containers are connected. The blood then escapes from the port 7 of the auxiliary container 3, reaches the pump 42, passes through the oxygenator 40 and any other units and then returns to the patient through the second end 38 of the return line; as mentioned, it is possible to provide that the container 2 also receives blood or other fluid through the suction or infusion lines. In this operating mode, however, the fluid level in containers 2 and 3 is practically the same as the two containers are connected.

Finally, it should be noted that the described device 1 and circuit 100 can be used sequentially in the described ways. More generally, by acting on the interception devices it is possible to carry out any temporally sequential combination of the operating modes described above.

Finally, from a constructive point of view, the device 1 can be made of plastic material for medical use. In particular, the rigid container 2 is built with rigid plastic material while the deformable wall can be made from a plastic film glued or welded to the wall provided on the rigid container 2. The various supply, discharge and by-pass channels can also be joined in one piece to the container 3, by gluing or welding. Thermally connected to the supply and discharge channels are connectors, such as Luer, for easy engagement and disengagement of the device 1.

TO

for example welded or glued on the adduction channel. The oxygenator can also be integrally joined to device 1, upstream of the Luer connector associated with the exhaust channel.

Claims (18)

CLAIMS 1. Device for collecting biological fluids (1) for medical use comprising: - at least one container selected from the group comprising: or a rigid container (2) internally defining at least a first chamber (2a) of fixed volume and or an auxiliary container (3) having at least one deformable portion (4) defining inside it a second chamber (3 a) of variable volume according to the position of the deformable portion (4); - at least one inlet door (6) connected to at least one said container; - at least one outlet door (7) connected to at least one said container; - an adduction channel (22) connected to the inlet port; - a discharge channel (23) connected to the outlet door; - a bypass channel (24) which has a first end (24a) connected to the supply channel (22) and a second end (24b) connected to the discharge channel (23) to bypass said collection device (1) of fluid; - a fluid interception member (25) operating on the bypass channel (24) and at least one of an interception member (26). from . fluid operating on the supply channel (22) and an interception member (27) operating on the discharge channel (23). 2. Device according to claim 1 comprising a rigid container (2) internally defining at least a first chamber (2a) of fixed volume and an auxiliary container (3) having at least one deformable portion (4) defining internally a second chamber (3a ) of variable volume according to the position of the deformable portion (4), optionally in which said deformable container comprises a bag. 3. Device according to any one of the preceding claims comprising at least one passage (5) capable of placing the first and second chambers (2a; 3a) in fluid communication. Device according to any one of the preceding claims, in which each container comprises a respective inlet port (6) and a respective outlet port (7), or in which only the auxiliary container comprises both the inlet port (6) and the exit door (7). 5. Device according to claim 2 or 3 or 4, in which the rigid container (2) has a box-like shape having at least one bottom wall (8), at least one side wall (9) emerging from the bottom wall (8) and at least a closing portion (10) placed at the top of the side wall (9), said walls defining the volume of the first chamber (2a); and in which there is at least one ventilation line designed to create a connection between the first chamber (2a) and the external environment. Device according to any one of the preceding claims, wherein said auxiliary container (3). It is defined. from . at least one . deformable portion (4) perimeter integral with at least a corresponding portion of the side wall (9) of the rigid container (2). 7. Device according to any one of the preceding claims, in which the rigid container (2) and the auxiliary container (3) are mutually side by side, and in which: - or a portion of the side wall (9) of the rigid container (2) acts as a separation wall between the first and second chamber (2a; 3 a) and constitutes a portion of the common wall between the two rigid and auxiliary containers (2 ; 3), or - the auxiliary container (3) comprises a respective bag integrally connected with the rigid container (2). 8. Device according to any one of the preceding claims, in which a portion of the side wall (9) of the rigid container (2) emerges, with reference to an operating configuration in which said side wall (9) extends from the bottom towards the ™ high, a part (14) developing below the first chamber (2a) and in extension with respect to the side wall (9); and in which the auxiliary container (3) comprises a rigid wall formed by a portion of the side wall (9) of the rigid container (2) and by said part (14) extending below the first chamber (2a) and a flexible wall perimeter fixed tightly on said rigid wall of the auxiliary container (3). 9. Device according to any one of the preceding two claims, wherein said part (14) extending below the first chamber (2a) has an arched conformation with concavity facing towards the interior of the second chamber (3 a). 10. Device according to any one of the preceding claims, in which the passage (5) which places the first and second chambers (2a; 3 a) in fluid communication is located at the bottom of the first chamber (2a), optionally in which the bottom wall (8) of the first chamber (2a) is inclined from top to bottom, proceeding towards the second chamber (3 a), so that the outflow of fluid through the passage (5 ) connecting the first to the second chamber (2a; 3 a). 11. Device according to any one of claims 3 to 10, wherein said device (1) comprises at least one fluid interception element (15) which can be manually activated from the outside by means of a tap or which can be controlled by means of an actuator member and operates in correspondence with of the passage (5) which places the first and second chambers (2a; 3a) in fluid communication, said fluid interception element (15) being displaceable between a first operating position in which a passage of fluid is allowed between the first and second chamber (2a; 3 a) and a second operating condition in which the passage of fluid between the first and second chamber (2a; 3 a) is prevented; and optionally in which: said fluid interception element (15) comprises a substantially cylindrical wall element (16) rotatably engaged inside said passage (5) and having at one of its axial ends an opening (17a) for the passage of fluid placed in communication with the first and / or second chamber (2a; 3 a) and also having a fluid passage opening (17) made in correspondence with a lateral wall of the cylindrical surface; following an angular rotation of the fluid interception element (15), the opening (17) placed on the cylindrical wall can be moved between a condition in which this opening opens and places said first chamber in fluid communication ( 2a) with the second chamber (3a), and a second position angularly offset with respect to the first position in which the opening (17) placed on the cylindrical side wall is closed by a corresponding part of said passage (5) thus preventing fluid communication between the first and second chambers (2a; 3a). Device according to any one of claims 8 to 11, wherein the entrance door (6) is located at the rigid part (14) extending below the first chamber (2a) and the exit door (7) Ã It is located in correspondence with the lowest position, with reference to an operating condition of the device, of the second chamber (3 a), optionally in correspondence with the vertically lowest area of the rigid part (14). 13. Device according to any one of the preceding claims, wherein said entrance and / or exit door (6; 7) are located, with reference to an operating condition of the device, at a lower height than the passage (5) which places the first in fluid communication with the second chamber (2a; 3a). Device according to any one of the preceding claims, wherein said rigid container (2) comprises at least one filter element (18) placed in correspondence with said first chamber (2a) and having an access side (19) to receive fluid to be filtered coming from connectors for the suction lines, and an outlet side (21) capable of supplying filtered fluid towards said bottom wall (8) of the first chamber (2a). Device according to any one of the preceding claims, in which the supply channel (22) comprises at least a first channel (22a) which places the supply channel (22) in fluid communication with the inlet port (6) of the container rigid, and at least a second channel (22b) which places said supply channel (22) in fluid communication with at least the outlet port (7) of the rigid container and / or wherein the supply channel (22) comprises at least a third channel (22d) which places the supply channel (22) in fluid communication with at least the inlet port (6) of the auxiliary container, and at least a fourth channel (22e ) which places said supply channel (22) in fluid communication with at least the outlet port (7) of the auxiliary container. 16. Device according to the preceding claim, in which an interception member operates on the first channel (22a), on the second channel (22b) and / or on a section of the supply channel which connects the first with the second channel (22a, 22b ); and / or in which an interception member operates on the third channel (22d), on the fourth channel (22e) and / or on a section of the adduction channel which connects the third with the fourth channel (22d, 22e). 17. Device according to claim 16 or 17, in which the first end (24a) of the bypass channel (24) is connected upstream of the interception member applied on the first channel (22a), and in which the second end (24b) of the bypass channel (24) is connected downstream of the interception device applied on the second channel (22b), optionally downstream of the fourth channel (22e). 18. Extracorporeal circuit (100) for the treatment of blood comprising: at least one blood collection line (32) having a first end (33) connectable to at least one access (34) to the patient and at least a second end (35) placed in fluid communication with at least one inlet port (6) to the device (1); - at least one blood return line (36) having a first end (37) connected to at least one exit port (7) from the device (1) and at least a second end (38) connectable to an access (39) to the system cardiovascular of the patient; and - at least one collection device (1) interposed between the collection line (32) and the return line (36), said collection device (1) being of the type according to any one of the preceding claims, and optionally at least one unit oxygenation unit (40) located downstream of the collection device (1), in correspondence with the blood return line (36) to the patient.