Device for the reversal of the blood flow of the branches of central venous catheters for extracorporeal purification

Abstract

The present invention relates to medical devices, characterized as central venous catheters (CVC) for obtaining extracorporeal blood circulation in order to implement various purification methods. In particular the present invention relates to a device for reversing the flow in the branches of a central venous catheter (CVC) for extracorporeal circulation comprising at least two connections for the CVC (2) (3) and two connections for the extracorporeal circulation (4) (5) and a carriage (7) sliding on a rail (10), inside of which, a series of lumens (9) for connecting the CVC connections (2) (3) with the lines of the extracorporeal circulation (4) (5) is present. Thanks to the series of lumens (9) integrated in the carriage (7) preferably slidable mounted in a support module (1) of the CVC, the present invention allows for reversing the flow of the branches of the CVC (2) (3) preferably by direct action on a switch (11), which acts upon the carriage (7), which slides on the rail (10) without the need to manipulate and open the CVC and the extracorporeal circulation.

Description

[0001] DEVICE FOR THE REVERSAL OF THE BLOOD FLOW OF THE BRANCHES OF

[0002] CENTRAL VENOUS CATHETERS FOR EXTRACORPOREAL PURIFICATION

[0003] DESCRIPTION

[0004] CROSS REFERENCE TO RELATED APPLICATIONS

[0005] This application claims priority benefit of Italian patent application No. 10 2023 000015918 filed on 27 July 2023, the contents of which are hereby incorporated by reference.

[0006] BACKGROUND AND STATE OF THE ART

[0007] The present invention relates to medical devices, characterized as central venous catheters (CVC) for obtaining extracorporeal blood circulation in order to implement various methods of purifying a patient's blood. The present invention allows for reversing the blood flow in the branches of a CVC in order to maintain suitable extracorporeal circulation, preferably circulation of blood for its purification. The present invention aims to allow blood flows in the CVC branches to be reversed in order to maintain extracorporeal blood circulation even in cases of CVC dysfunction requiring the extracorporeal CVC circulation lines to be reversed.

[0008] A CVC is of critical importance in extracorporeal purification, in that it is a medical device which allows for obtaining a suitable blood flow as required by various extracorporeal purification treatments, which, in order to be efficient and safe, require a blood flow, which must be constant and sufficient when measured in milliliters per minute according to the physical and chemical purification principles, which the blood must be subjected to, through the use of one or more purification devices (filters, cartridges, resins, and a combination of devices). In case of an insufficient or discontinuous blood flow, extracorporeal circulation may not be suitable to achieve the clinically required purification for a patient. Specifically, a CVC typically (see e.g. Fig. 1) comprises at least 2 lumens which may have different geometry and, which are intended to withdraw blood from the patient (arterial lumen, A) and return the blood to the patient (venous lumen, V). The blood withdrawn from the arterial lumen is carried by the arterial line of the extracorporeal circulation (arterial line, A) to the extracorporeal purification site, while the venous line (venous Line, V) connected to the venous lumen of the CVC channels blood back into the patient once the blood has been purified. The two lumens are preferably connected to the extracorporeal circulation through a connection, preferably a specific standard Luer Lock connection for all types of extracorporeal circulation in order to establish a universal CVC for all existing methods and all purification monitors on the market.

[0009] Given that the blood collected from the patient, purified, and subsequently returned to the patient must not recirculate in the venous lumen to reduce the purification efficacy, the point of withdrawing blood from the venous vessel is preferably situated upstream of the point of return, such that the purified blood is returned distally to its withdrawal and cannot be re-aspirated into the extracorporeal circulation and reduce the efficacy of the purification method, which would continue to act on a volume of blood that has already been partially purified (see Fig. 1).

[0010] This configuration may be obtained from a CVC geometry, which requires the arterial branch to aspirate proximally and the venous branch to aspirate distally, such that the withdrawn blood returns to the vessel distally to the withdrawal site. This geometry is preferably also acted upon by the blood flow of the venous vessel, where the CVC is placed, which, when flowing from the arterial lumen to the venous lumen, causes a continuous movement of the blood returned to the venous lumen distally, thereby minimizing the possibility of re-aspiration of a blood volume at the arterial branch (see Fig. 1).

[0011] This operating conformation is preferably defined as "straight-connected CVC or non-inverted CVC" for the extracorporeal circulation. To be precise, in this configuration, the arterial branch of the CVC is preferably connected to line A of the extracorporeal circulation and the venous branch to line V of the extracorporeal circulation. The straight-connected CVC or non-inverted CVC may be abbreviated as ACVCAEC - VCVCVEC or short AA-VV, wherein

[0012] Acvc and Vcvc stand for the arterial (A) or venous (V) branch the CVC, while AEC and VEC stand for line A and V of the extracorporeal circulation.

[0013] However, in common clinical practice, situations may occur, in which a CVC is incorrectly positioned within the central venous lumen, or that it dislocates or bends, or that the venous vessel has anatomical alterations (thrombosis , stenosis, aneurysms, non-physiological curves, etc.), which cause a malfunction of the CVC resulting in reduced blood flows, or complete or partial dysfunction of one of the two lumens of the A or V branches, which impacts the ability to aspirate or return the blood in the venous vessel. Phenomena of partial coagulation of the lumens of branches of a CVC near the point of aspiration or return of the blood may alter the blood flows, as well as result in the inability to aspirate or return the blood.

[0014] In such situations, in order to obtain sufficient blood flow, it may become necessary that the CVC is used in the “inverted CVC” or "reversed CVC" conformation, i.e., a configuration, in which the two branches of the CVC are reversely (inversely) connected to the extracorporeal circulation, resulting in the aspiration of blood from the venous branch and its return from the arterial branch (AV-VA).

[0015] This reversal procedure may be required repeatedly during extracorporeal treatment and in the state of the art requires handling of the CVC and extracorporeal circulation lines by an experienced operator. Such handling may result in several of the most serious complications from air entering the CVC, contamination of the CVC by bacteria, and coagulation of the CVC when performing the reversal maneuver at inappropriate times.

[0016] These complications are a core clinical risk for the patient, which includes major clinical complications that may lead to the development of CVC-related sepsis (very serious infection of the whole body, with the risk of death) and the loss of one or both lumens of the CVC in case of coagulation of the lumen itself. As for extracorporeal circulation, dysfunction of the CVC with the continuous need for reversal of the lumens, or the inability to obtain suitable flow from the branches of the CVC, or continuous interruptions of the extracorporeal circulation due to excessively fluctuating blood flows, may result in coagulation of the extracorporeal circulation and the devices used for purification. This situation has a negative impact on the clinical risk as reflected in a patient's blood loss, increased patient management costs, and medical staff overload due to requests for continuous maintenance interventions on CVCs and extracorporeal purification.

[0017] The maneuvers for reversing a CVC also require specific manual and operational skills for the CVC and extracorporeal circulation not always possessed by average operators in the field, which could result in incorrect maneuvers and damage to both the CVC and the extracorporeal circulation. It is obvious from the above that a CVC plays a crucial role in obtaining extracorporeal circulation, i.e., ensuring adequate flows for the purification method being used. In case of dysfunction, it will therefore be necessary to do one or more reversals of the branches in time, while exposing the patient and the purification method to clinically relevant complications.

[0018] The manipulation of the CVC and the opening of the extracorporeal circulation to proceed with the reversal of the branches on the lines of the extracorporeal circulation are therefore deemed maneuvers with the risk of immediate or subsequent complications (bacterial contamination of the CVC medical device, infection of the CVC patient related to the dissemination of bacteria and fungi in the bloodstream). From a clinical point of view, these complications are so important that they are being considered a priori by clinicians, when a patient needs to undergo extracorporeal purification, and the risks / benefits of the presence of the CVC are weighed before proceeding with its positioning in a central venous vessel.

[0019] To overcome these problems, the present invention aims to make possible the reversal of the CVC branches on the lines of the extracorporeal circulation without direct manipulation of the branches without opening the extracorporeal circulation, thus minimizing the clinical complications associated with all operations required for reversal of the CVC. To reverse the flow in the CVC branches, in the prior art it is typically necessary to block the extracorporeal circulation, clamp all the lines and branches of the CVC, open the connections, reverse the lines on the branches of the CVC, unclamp the lines and branches, and restart extracorporeal circulation. These complex maneuvers require certain manual skills and can result in complications, as described above.

[0020] OBJECTIVE OF THE INVENTION

[0021] An objective of the invention is to overcome the disadvantages of the prior art. In particular an objective of the invention is to provide for a device which allows for reversing the blood flow in the branches of a CVC for an extracorporeal circulation in a more simple, safe and time-efficient manner without requiring complex maneuvers.

[0022] SUMMARY OF THE INVENTION

[0023] The objective of the invention is solved by the independent claim relating to a device for reversing the flow in the branches of a central venous catheter (CVC) for extracorporeal circulation. Preferred embodiments are disclosed in the dependent claims.

[0024] The invention preferably relates to a device for reversing the flow in the branches of a central venous catheter (CVC) for extracorporeal circulation comprising at least two connections for the CVC and two connections for the extracorporeal circulation and a carriage sliding on a rail, inside of which, a series of lumens for connecting the CVC connections with the connections for the extracorporeal circulation lines is present.

[0025] In a preferred embodiment of the invention the series of lumens allow for different connections of the CVC connections with the lines of the extracorporeal circulation. In preferred embodiments at least one connection relates to a non-inverted CVC conformation or straight-CVC (AA-VV) and at least one connection relates to an inverted CVC" conformation (AV-VA). In particular, a series of lumens or sets of lumens may be provided, wherein each lumen or set of lumens correspond to a specific connection of the CVC connections with connections for the lines of the extracorporeal circulation. For instance, a first lumen or first set of lumens may provide for a non-inverted CVC conformation allowing for two straight connections or fluid paths, such that the arterial branch (A) of the CVC is preferably connected to line A of the extracorporeal circulation and the venous branch (V) to line V of the extracorporeal circulation (see also Fig. 2). Furthermore, a second lumen or second set of lumens may provide for an inverted CVC conformation allowing for a crossed connection or crossed fluid communication of the arterial branch (A) of the CVC to the V line of the extracorporeal circulation and the venous branch (V) to line A of the extracorporeal circulation (AV-VA) (see also Fig. 3).

[0026] Advantageously changing the connection configuration, e.g. from a non-inverted CVC conformation (AA-VV) to an inverted CVC conformation (AV-VA) may be simply achieved by sliding the carriage containing the series of lumens on a rail, wherein depending on the position of the carriage with respect to the connections of the CVC and extracorporeal circulation a desired conformation may be selected. The sliding preferably refers to a linear movement of the carriage. Said linear movement is preferably defined by a linear rail, on which the carriage slides.

[0027] As used herein the term lumen provided within the carriage preferably prefers to a (open) space within the carriage that allows for a fluid connection or fluid communication from a first surface of the carriage through the carriage to a second (preferably) opposing surface of said carriage. The lumens inside the carriage thus preferably defines a possible fluid path within the carriage, which as detailed herein allows for different connection modes or different configurations for providing a fluid communication between CVC connections and / or connections to an extracorporeal circulation. Except for the lumens provided in said carriage the carriage preferably consists of a body, preferably made of a solid, fluid-impermeable material.

[0028] Inside the carriage the series of lumens or sets of lumens are preferably provided along a linear axis of the carriage, which aligns with the direction the linear translation. Hence, by sliding the carriage along the linear rail, different lumens or sets of lumens of lumens may be aligned with the CVC connections and connections to extracorporeal lines, such that different configurations of connections between said connections may be established, e.g. corresponding to a non-inverted CVC (AA-VV) conformation or an inverted CVC (AV-VA)conformation.

[0029] In preferred embodiments the device comprises a support module having a cavity which accommodates the carriage whose volume contains the series of lumens for different connections.

[0030] Accommodating preferably means in this context that the carriages snugly fits into said cavity, wherein a cross-section of the carriages approximately corresponds to a cross-section of the cavity of the support module.

[0031] In preferred embodiments the carriage essentially consists of a parallelepiped or is a parallelepiped, preferably a cuboid, rectangular cuboid or cube. The carriage may however for instance also have the shape of a general cylinder with a circular or elliptic faces or that of a general prisma with polygonic faces having three, five, six or more vertices.

[0032] Preferably the support module serves on the one hand to accommodate the carriage and on the other hand supports the CVC connections and connections to the extracorporeal lines. While sliding inside the support module the carriage including the lumens may thus be translated with respect to the CVC connections and connections to the extracorporeal lines to provide for different conformations of connections between these connections as described above.

[0033] By providing a support module with the connections to the CVC and / or extracorporeal lines, the device is preferably intended as a device to be connected to the CVC and not an integral part of the CVC. Preferably by means of the provided CVC connections the device can be preferably connected to any commercially available CVC. To this end preferably standard luer-lock connections, may be preferred. In some embodiments the device may comprise a CVC presently connected to said CVC connections.

[0034] In preferred embodiments the device comprises a switch for sliding the carriage on the rail in order to allow for different connections of the CVC branches to the extracorporeal circulation lines. The switch may for instance relate to a handle directly or indirectly attached to the carriage such that moving the switch allows to move the carriage on the rail in order to provide for a different mode of connection of the CVC branches to the extracorporeal circulation lines. By positioning the switch at a precise location of the carriage inside the slide rail a proper connection of the respective lumens with the connections to the CVC branches and / or extracorporeal circulation lines may be ensured.

[0035] In preferred embodiments of the invention the device comprises a selection and locking system of the carriage, preferably with respect to its position on the rail and / or with respect to the connections for the CVC branches and / or extracorporeal circulation lines. As stated above, preferably a series of lumens or sets of lumens may be provided, wherein each lumen or set of lumens correspond to a specific connection of the CVC connections with the connections for the lines of the extracorporeal circulation. By providing a selection and locking system of the carriage it may be easily ensured that the carriage comprising the series of lumens is fixed in a correct position for providing a desired conformation, e.g. a non-inverted or inverted CVC.

[0036] To this end the selection and locking system of the carriage may comprise different means. For instance, the selection and locking system of the carriage may relate to a fixation means of the switch (attached to the carriage) once it is moved to a desired position in respect to the rail and / or support module. Alternatively, the selection and locking system of the carriage may relate to fixation means for the carriage with respect to the rail and / or the support module.

[0037] In a preferred embodiment of the invention the selection and locking system of the carriage comprises of pre-fixed grooves and protrusions. For instance, pre-fixed grooves may be provided in a support module, while corresponding protrusions may be provided in the carriage or vice versa.

[0038] Said grooves and protrusions may thus provide for a (detachable) joint between the support module and the carriage for specific positions of the carriage inside the support module corresponding to specific connections modes. Advantageously, by pulling the carriage, e.g. by means of a switch, the resistance of a joint established by the grooves / protrusions may be overcome and the protrusion (e.g. situated on the carriage) may be brought into another groove (e.g. situated in the support module) corresponding to another connection configuration between the lumens of the extracorporeal circulation and the branches of the CVC.

[0039] In preferred embodiments of the invention the device is characterized in that a part of the carriage which is in contact with the rail, comprise of a biocompatible member, preferably a biocompatible membrane, capable of sealing the connection between the carriage and the rail. The biocompatible membrane may be preferably of a gasket type. Preferably the biocompatible membrane comprises openings at the position of the lumens inside of the carriage, but otherwise continuously seals or covers the surface of the carriage. This ensures a particular liquid tight connection between the lumens of the carriage and the CVC connections and / or connections to the extracorporeal lines, preferably provided in the support module.

[0040] If for instance, the carriage is moved towards a position where no lumen inside the carriage aligns with a certain connection, e.g. the atrial (A) line of the extracorporeal circulation (see for instance Fig. 4), the biocompatible membrane ensures a particular liquid tight sealing at this position. At positions however where a lumen inside the carriage aligns with a connection, e.g. the atrial branch of the CVC (see also for instance Fig. 4), the biocompatible membrane ensures that a fluid connection between the arterial branch of the CVC and the lumen is provided, while a spilling or undesired outflow of fluid is effectively impeded.

[0041] In preferred embodiments of the invention the device further comprises one or more connections for fluid infusion, preferably at least two, more preferably at least three connections for fluid infusion. The connections for fluid infusion preferably relate to additional connections, preferably provided with the support module, which allow for introducing a desired fluid (preferably liquid) into one of the branches of the CVC and / or one of the lines of the extracorporeal circulation. For instance, as depicted in Fig. 5 a connection for fluid infusion may be used in order to introduce a fluid (F), e.g. a saline solution, into the venous (V) branch of the CVC. Likewise, as depicted for instance in Fig. 6 a connection for fluid infusion may be used in order to introduce a fluid (F), e.g. a saline solution, into the arterial (A) line of the extracorporeal circulation.

[0042] Advantageously, a corresponding lumen or set of lumens may be equally provided in the carriage to allow for a desired connection mode between the CVC connections, the connections, to the extracorporeal lines and the one or more connections for a fluid infusion.

[0043] The person skilled in the art understands that embodiments disclosed herein regarding the provision of a carriage with a series of lumens to allow for a selection of a desired confirmation or connection mode between CVC connections and connections to an extracorporeal circulation in a device having at least two CVC connections and at least two connections to an extracorporeal circulation equally apply to devices having at least two CVC connections and at least two connections to an extracorporeal circulation as well as one or more connections for a fluid infusion.

[0044] Accordingly, in preferred embodiments wherein the device further comprises one or more connections for fluid infusion, it may be preferred that a series of lumens in the carriage are provided wherein the series of lumens allow for different connections of the CVC connections with the lines of the extracorporeal circulation and / or the one or more connections for a fluid infusion. Moreover likewise, in preferred embodiments wherein the device further comprises one or more connections for fluid infusion, it may be preferred that the device comprises a switch, wherein the switch allows for sliding the carriage on the rail in order to allow for different possible connections between the CVC branches to the extracorporeal circulation lines and / or the one ore more connections for fluid infusion.

[0045] The device according to the present invention allows for a number of advantages.

[0046] Thanks to a system or series of lumens integrated into a carriage preferably slidably mounted in a support (module) of a CVC, the present invention allows for reversing the flow of the branches of the CVC preferably by direct action on a switch, which acts upon a carriage , which slides on a rail without the need to manipulate and open the CVC and the extracorporeal circulation.

[0047] In particular the device of the present invention preferably:

[0048] • makes it possible to reverse the branches of the CVC on the lines of the extracorporeal circulation without manipulating the branches directly,

[0049] • makes it possible to perform this reversal procedure in about 1-2 seconds, compared with the current 15-20 seconds by an expert operator, and 30-45 seconds by an average operator, and 60-90 seconds by an inexperienced operator,

[0050] • makes it possible to obtain reiterated reversal of the branches in time without opening up the extracorporeal circulation (disconnection of the lines and reversed reconnection from AA-VV to AV-VA),

[0051] • makes it possible to perform an infinite number of reversals of the CVC branches over time without the risk of damaging the CVC and extracorporeal circulation,

[0052] • makes possible the infusion of solutions, drugs, chemotherapeutics, etc., in the branches of the CVC and the extracorporeal circulation without opening the lines of the extracorporeal circulation and without applying taps to the lines and the CVC (this is typically not permitted by the manufacturers of the various monitors for extracorporeal circulation, in that such devices inserted between a CVC and the extracorporeal circulation lines could result in the failure to detect accidental disconnection of the lines with entry of air into the extracorporeal circulation (disconnection of line A) or the loss of blood (disconnection of line V) To this end as stated above provision of one or more connections for the infusion of a fluid (preferably liquid) may be provided in a straight forward manner.

[0053] • the present invention has a time window of use similar to that of temporary CVCs, thus avoiding direct manipulation of the CVC and establishing a barrier to colonization by bacteria present in the environment. In the case of permanent CVCs (tunneled CVCs) the present invention may be modified regularly for the duration of the life of the CVC, thus ensuring the barrier effect.

[0054] As used herein, the terms “comprising” and “including” or grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. This term encompasses the terms “consisting of’ and “consisting essentially of’.

[0055] Thus, the terms “comprising” / “including” / ”having” mean that any further component (or likewise features, integers, steps and the like) can / may be present. The term “consisting of’ preferably means that no further component (or likewise features, integers, steps and the like) is present.

[0056] The term “consisting essentially of’ or grammatical variants thereof when used herein are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof but only if the additional features, integers, steps, components or groups thereof do not materially alter the basic and novel characteristics of the claimed device. Thus, the term “consisting essentially of’ means those specific further components (or likewise features, integers, steps and the like) can be present, namely those not materially affecting the essential characteristics of the device. In other words, the term "consisting essentially of (which can be interchangeably used herein with the term "comprising substantially"), allows the presence of other components in the device in addition to the mandatory components (or likewise features, integers, steps and the like), provided that the essential characteristics of the device are not materially affected by the presence of other components.

[0057] Terms such as substantially, approximately, about, etc. preferably describe a tolerance range of less than ± 20%, preferably less than ± 10%, even more preferably less than ± 5% and in particular less than ± 1%. Indications of substantially, approximately, about, etc. always also disclose and include the exact value mentioned.

[0058] DETAILED DECRIPTION AND FIGURES

[0059] The present invention is described in, but no limited to one embodiment. The present invention is further described by reference to the following figures (not to scale). The figures exemplify nonlimiting and potentially preferred embodiments, presented for further illustration of the invention.

[0060] Brief description of the figures

[0061] Fig. 1 Schematic illustration of a preferred embodiment of a device according to the invention connected to a central venous catheter (CVC) and an extracorporeal circulation.

[0062] Fig. 2 Schematic illustration of a preferred embodiment of a device according to the invention, wherein the carriage comprising the series of lumens is positioned for a non-inverted or straight-CVC conformation (AA-VV).

[0063] Fig. 3 Schematic illustration of a preferred embodiment of a device according to the invention wherein the carriage comprising the series of lumens is positioned for an inverted CVC conformation (AV-VA).

[0064] Fig. 4 Schematic illustration of a preferred embodiment of a device according to the invention, wherein the device comprises one or more connections for a fluid infusion and the carriage comprising the series of lumens is positioned to provide for a connection between a connection for fluid infusion to the arterial branch of the CVC as well as a connection of the venous line of the extracorporeal circulation to the venous branch to the CVC (FAcvc-VV).

[0065] Fig. 5 Schematic illustration of a preferred embodiment of a device according to the invention wherein the device comprises one or more connections for a fluid infusion and the carriage comprising the series of lumens is positioned to provide for a connection of the arterial line of the extracorporeal circulation to the arterial branch of the CVC as well as a connection between a connection for fluid infusion to the venous branch of the CVC (AA-FVcvc).

[0066] Fig. 6 Schematic illustration of a preferred embodiment of a device according to the invention, wherein the device comprises one or more connections for a fluid infusion and the carriage comprising the series of lumens is positioned to provide for a connection between a connection for fluid infusion to the arterial line of the extracorporeal circulation as well as a connection of the venous line of the extracorporeal circulation to the venous branch to the CVC (FAEC-VV).

[0067] Fig. 7 Schematic illustration of a preferred embodiment of a device according to the invention, wherein the carriage comprising the series of lumens has been moved in a closing position, wherein the connections to the branches of the CVC and to the extracorporeal circulation are closed or sealed. Detailed description of figures

[0068] Fig. 1 is a schematic illustration of a preferred embodiment of a device according to the invention connected to a CVC and an extracorporeal circulation. A CVC typically comprises of at least 2 lumens intended to withdraw blood from a patient (arterial lumen, A) and return blood to the patient (venous lumen, V).

[0069] The blood drawn from the arterial lumen is carried by the arterial line of the extracorporeal circulation (arterial line, A) to the extracorporeal purification site, while the venous line (venous Line, V), connected to the venous lumen of the CVC, channels blood back into the patient.

[0070] As depicted in Fig. 1 the device according to the invention provides at least two CVC connections, in particular a first CVC connection (2) towards the arterial branch (A) of the CVC and a second CVC connection (3) to the venous branch (V) branch of the CVC. The device according to the invention further provides at least two connections for an extracorporeal circulation, in particular a first connection (4) towards the arterial line (A) of extracorporeal circulation and a second connection (5) to the venous line (V) extracorporeal circulation.

[0071] As will be explained in more detail below the device according to the invention allows for different connections between the CVC connections (2) (3) as well as the connections to the extracorporeal connections (4) (5).

[0072] Considering that the blood withdrawn from the patient and subsequently returned to the patient may not recirculate in the venous lumen, the point of withdrawing blood from the venous vessel is preferably located upstream of the return point. Preferably, a configuration is obtained from the geometry of a CVC, which requires the arterial branch to aspirate proximally and the venous branch to aspirate distally, such that the withdrawn blood returns to the vessel distally to the withdrawal site.

[0073] The described operating mode is preferably denoted as "a straight-connected CVC or a non- reversed CVC" for the extracorporeal circulation. To be precise, in this configuration, the arterial branch of a CVC (2) is connected to the A line of the extracorporeal circulation (4) and the venous branch (3) is connected to the V line of the extracorporeal circulation (5) (AA-VV).

[0074] However, in common clinical practice, situations may arise, in which a CVC is positioned incorrectly within the central venous lumen, or that it dislocates or bends, or that the venous vessel has anatomical alterations that result in malfunctioning of the CVC. In such cases, to obtain sufficient blood flow, it is necessary to use the CVC in the "inverted CVC" conformation, i.e., a configuration in which the two branches of the CVC must be inversely connected to the extracorporeal circulation, thus resulting in the aspiration of blood from the venous branch and its return from the arterial branch (AV-VA).

[0075] The device according to the present invention advantageously allows the blood flow in the branches of a CVC to be reversed in order to maintain suitable extracorporeal blood circulation as exemplified in figure 2 and 3.

[0076] The depicted device comprises a support module (1), which includes connections, preferably Luer Lock connections for a branch A of the CVC (2), branch V of the CVC (3), line A of the extracorporeal circulation (4), and the V line of the extracorporeal circulation (5). The support module (1) has a cavity (6), which accommodates a carriage (7) essentially consisting of a parallelepiped (8) whose volume contains lumens (9) of different geometry, which connect the different connections, preferably different Luer Lock connections, thereby making it possible to obtain the AA-VV and AV-VA configurations described above. The carriage (7) has a slide rail (10), which allows it to be moved by means of a switch (11). The part of the carriage (7), which is in contact with the rail (10), preferably comprises of a biocompatible material capable for sealing the connection between the carriage (7) and the rail (10), thereby allowing the connections, preferably Luer Lock connections, to be connected by the different lumens (9). Fig. 2 is a schematic illustration of a preferred embodiment of the device wherein the carriage comprising the series of lumens 9 is positioned for a non-inverted or straight-CVC conformation (AA-VV). In the AA-VV configuration (straight or non-reversed CVC) of Fig. 2the Luer Lock connection of branch A of the CVC (2) is made to communicate with line A of the extracorporeal circulation (4) through the use of a prepared lumen (12) contained in the parallelepiped (8) of the carriage (7). The same applies to the V branch of the CVC (3) which is connected to the V line of the extracorporeal circulation (5) via the specific lumen (13). This configuration is preferably obtained from the precise location of the carriage (7) inside the slide rail (10) obtained by the position of a switch (11).

[0077] In the preferred depicted embodiment, the switch (11) makes it possible to keep the carriage (7) in the correct position thanks to a mechanism on the base of the parallelepiped (8) essentially consisting of a joint between a groove (14) of the support module (1) and the carriage (7) which has a protrusion (15) that fits perfectly into the groove (14). If pulling the switch (11), the resistance of the joint may be advantageously overcome and the protrusion (15) of the carriage (7) brought into another groove (14) corresponding to another connection configuration between the lumens of the extracorporeal circulation and the branches of the CVC. The inside of the parallelepiped (8) of the carriage (7) has a series of lumens with different geometry, which connect the connections, preferably Luer Locks, of the CVC (2) (3) and the extracorporeal circulation (4) (5) such as to obtain different connection configurations.

[0078] To effect the reversal of the lumens of the CVC (2) (3) from the AA-VV configuration to the AV-VA configuration (see Fig. 3), the carriage (7) is moved to the desired position, whereby (the CVC being reversed) the Luer Lock of branch A of the CVC (2) is placed in communication with the V line of the extracorporeal circulation (5) by using a prepared lumen (16) contained in the parallelepiped (8) of the carriage (7); the same applies to the V branch of the CVC (3) connected to the line a of the extracorporeal circulation (4) through the specific lumen (17). Fig. 3 is a schematic illustration of the preferred embodiment of the device wherein the carriage comprising the series of lumens is positioned for the inverted CVC conformation (AV-VA).

[0079] The lumens (16) (17) for reversing the CVC (2) (3) are contained in the parallelepiped (8) of the carriage (7) and allow for a direct connection of the lumens of the branches of the CVC (2) (3) to the lines of the extracorporeal circulation (4) (5); to keep the connection between the carriage (7) and Luer Lock (2) (3) (4) (5) present in the support module (1) sealed, a biocompatible membrane (preferably of the gasket type) (18) is situated between the carriage (7) and the slide rail (10), thus ensuring that the connection is sealed without the loss of blood material / fluids present in the lumens.

[0080] To be able to infuse fluids into the arterial branch of the CVC (2) or the venous branch of the CVC (3) or the arterial line of the extracorporeal circulation (4), the carriage (7) may be moved on the rail (10) to connect the branch artery (2) with a connection (19), preferably a Luer Lock connection connected with a suitable fluid (F), for instance a saline solution (Figs. 4-5-6).

[0081] Fig. 4 is a schematic illustration of a preferred embodiment of a device according to the invention wherein the device comprises two connections (19) for a fluid infusion (F) and the carriage (7) comprising the series of lumens (9) is positioned to provide for a fluid communication between a connection for fluid infusion (19) to the connection (2) to the arterial branch of the CVC as well as a connection of the venous line of the extracorporeal connection (5) to the venous branch to the CVC (3). Said configuration may also be abbreviated as FAcvc-W.

[0082] Fig. 5 is a schematic illustration of a preferred embodiment of a device according to the invention wherein the device comprises two connections (19) for fluid infusion (F) and the carriage (7) comprising the series of lumens (9) is positioned to provide for a fluid communication between the connection (4) of the arterial (A) line of the extracorporeal connection to the connection (2) to the arterial (A) branch to the CVC as well as a fluid communication between a connection (19) for fluid infusion to the connection (3) for the venous (V) branch of the CVC. Said configuration may thus also be abbreviated as AA-FVcvc.

[0083] Fig. 6 is a schematic illustration of a preferred embodiment the device comprises two connections (19) for fluid infusion (F) and the carriage (7) comprising the series of lumens (9) is positioned to provide for a fluid communication between a connection (19) of fluid infusion to the connection (4) for the arterial (A) line of the extracorporeal circulation as well as a fluid communication between the connection (5) for the venous line of the extracorporeal circulation and the connection (3) to the venous branch of the CVC. Said configuration may thus also be abbreviated as FAEC-VV). The many connections obtainable by moving the carriage (7) inside the slide rail (10) through the use of the switch (11), which makes possible the correct positioning of the carriage (7) for the connections between the connections, preferably Luer Locks, (2) (3) (4) (5) (19) obtainable from the various lumens (9), may be numerous and not limited to those described in relation to Figs. 2- 6 including a closing position (see Fig. 7) of both branches A and V of the CVC (2 ) (3) and the extracorporeal circulation (4) (5).

[0084] REFERENCE SIGNS

[0085] 1 Support module of the device

[0086] 2 Connection to the arterial (A) branch of the CVC

[0087] 3 Connection to the venous (V) branch of the CVC

[0088] 4 Connection to the arterial (A) line of the extracorporeal circulation

[0089] 5 Connection to the venous (V) line of the extracorporeal circulation

[0090] 6 Cavity

[0091] 7 Carriage

[0092] 8 Parallelepiped

[0093] 9 Lumen

[0094] 10 Rail

[0095] 11 Switch

[0096] 12, 13 Lumen(s) for a non-inverted CVC configuration (AA-VV)

[0097] 14 Grooves

[0098] 15 Protrusions

[0099] 16, 17 Lumen(s) for an inverted CVC configuration (AV-VA)

[0100] 18 Biocompatible membrane

[0101] 19 Connection to a fluid (F) infusion

Claims

CLAIMS1. Device for reversing the flow in the branches of a central venous catheter (CVC) for extracorporeal circulation comprising at least two connections for the CVC (2) (3) and two connections for the extracorporeal circulation (4) (5) and a carriage (7) sliding on a rail (10), inside of which, a series of lumens (9) for connecting the CVC connections (2) (3) with the connections for the extracorporeal circulation (4) (5) is present.

2. Device according to the previous claim, wherein the series of lumens (9) allow for different connections of the CVC connections (2) (3) with the connections for the lines of the extracorporeal circulation (4) (5).

3. Device according to one or more of the previous claims, wherein the device comprises a support module (1) having a cavity (6) which accommodates the carriage (7) whose volume contains the series of lumens (9) for different connections, wherein the carriage (7) is preferably a parallelepiped (8).

4. Device according to one or more of the previous claims, wherein the device comprises a switch (11) for sliding the carriage (7) on the rail (10) in order to allow for different connections between the connections for the CVC branches (2) (3) and the connections for the extracorporeal circulation lines (4) (5).

5. Device according to one or more of the previous claims, wherein the device comprises a switch (11) for sliding the carriage (7) on the rail (10) in order to allow for different connections of the connections for the CVC branches (2) (3) to the connections of the extracorporeal circulation lines (4) (5) through a selection and locking system of the carriage (7).

6. Device according to the previous claim,wherein the selection and locking system of the carriage (7) comprises pre-fixed grooves (14) and protrusions (15).

7. Device according to one or more of the previous claims, wherein a part of the carriage (7), which is in contact with the rail (10), comprises a biocompatible membrane (18) capable of sealing the connection between the carriage (7) and the rail (10).

8. Device according to one or more of the previous claims, wherein the device further comprises one or more connections for fluid infusion (19), preferably at least two, more preferably at least three connections for fluid infusion (19).

9. Device according to one or more of the previous claims, wherein the device comprises a switch (11), wherein the switch (11) allows for sliding the carriage (7) on the rail (10) in order to allow for different possible connections between the connections for the CVC branches (2) (3) to the connections for the extracorporeal circulation lines (4) (5) and / or the at least one or more connections for a fluid infusion (19).

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