Connector for extracorporeal blood circulation circuits

The connector for extracorporeal blood circulation circuits addresses pressure imbalances by using a one-way valve and adjustable air vents/intake holes to maintain consistent pressure, ensuring safe and efficient blood flow during surgical operations.

WO2026074353A1PCT designated stage Publication Date: 2026-04-09SIDAM SRL
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Patent Information

Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2025-09-11
Publication Date
2026-04-09

AI Technical Summary

Technical Problem

Existing connectors for extracorporeal blood circulation circuits fail to maintain consistent pressure within the circuit, leading to potential overpressure or vacuum conditions due to human error or obstructions, which can disrupt blood flow and pose risks to patients.

Method used

A connector with a one-way valve and adjustable air vents and intake holes that maintain pressure within the containment body by allowing air to escape or enter, restoring the predetermined pressure value during abnormal conditions.

Benefits of technology

The connector effectively compensates for pressure imbalances, ensuring optimal blood flow and circuit performance by quickly adjusting to overpressure or vacuum conditions, thereby maintaining safe and efficient operation.

✦ Generated by Eureka AI based on patent content.

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Abstract

The connector (1) for extracorporeal blood circulation circuits, comprises: - at least one substantially hollow containment body (2) and provided with at least one inlet opening (3), couplable to a supply line of blood stream, and at least one outlet opening (4) of the blood stream, couplable to a return line comprising at least one pumping device operable for the movement of the blood stream along a direction of circulation (5); - at least one valve device (6) allocated internally to the containment body (2) and adapted to allow the flow of the blood stream along the direction of circulation (5) from the inlet opening (3) to the outlet opening (4); wherein the containment body (2) comprises at least one through adjusting hole (10, 11) adapted to allow the flow of air between the outside and the inside of the containment body (2); the connector (1) further comprises: - adjusting means (12, 17, 18, 23) of the pressure inside the containment body (2) which means are adapted to adjust the flow of air passing through the least one adjusting hole (10, 11), the adjusting means (12, 17, 18, 23) and the at least one adjusting hole (10, 11) operating in conjunction in maintaining a pressure value inside the containment body (2) substantially equal to a predetermined pressure value.
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Description

[0001] CONNECTOR FOR EXTRACORPOREAL BLOOD CIRCULATION CIRCUITS

[0002] Technical Field

[0003] The present invention relates to a connector for extracorporeal blood circulation circuits.

[0004] Background Art

[0005] In particular, the connector to which this invention relates is adapted to be inserted into ECMO-type circuits, i.e., those used for extracorporeal blood recirculation and oxygenation.

[0006] During certain surgical operations, it may be necessary to temporarily suspend the functioning of a patient’s heart.

[0007] In such conditions, in order to ensure vital support for the patient, it is necessary to connect the patient’s circulatory system to an extracorporeal blood circulation circuit which ensures circulation and oxygenation.

[0008] Generally, these extracorporeal blood circulation circuits comprise a pump, specifically a peristaltic pump or a centrifugal pump, which is operated to take the blood which was previously drained into a reservoir, to send it to an oxygenator and to any other biomedical treatment devices, and to return it to the patient’s aorta once it has been oxygenated and treated.

[0009] In such extracorporeal blood circulation circuits, in addition to the main extracorporeal circulation line, secondary suction lines are used which allow blood to be conveyed from the surgical field or from the ventricle of the patient’s heart to the reservoir.

[0010] The connector to which the present invention relates can be positioned along these secondary suction lines and is configured to allow blood to flow to the reservoir and to prevent it from flowing in the opposite direction, i.e., towards the patient. These secondary suction lines are generally connected to a peristaltic pump that allows the blood to be moved.

[0011] In detail, the aforementioned secondary suction lines comprise a first stretch, connected downstream of the patient’s heart or of the surgical field and upstream of the connector, and a second stretch, connected downstream of the connector and upstream of the reservoir, where the downstream connection and the upstream connection must be meant in relation to the way of normal forward movement of blood into the circuit, i.e., from the heart or from the surgical field towards the reservoir.

[0012] Generally, the connectors for extracorporeal blood circulation circuits of known type comprise: a hollow containment body provided with an inlet opening, connected to the first stretch of the secondary suction line, and with an outlet opening, connected to the second stretch of the secondary suction line; and a valve of the one-way type located inside the containment body, between the inlet opening and the outlet opening, and adapted to allow blood to flow from the inlet opening to the outlet opening and to prevent it from flowing in the opposite direction.

[0013] However, blood circuit connectors of known type do have certain drawbacks, mainly related to the fact that they do not always guarantee that the pressure inside them and inside the circuit with which they are associated is maintained at a predetermined value.

[0014] In this regard, it should be noted that abnormal operating conditions can sometimes occur within extracorporeal blood circulation circuits, which can lead to pressure imbalances.

[0015] In particular, such pressure imbalances can occur when the pump is operated incorrectly, mainly due to human error, i.e., to push blood towards the heart or the surgical field, rather than to take it from these sites.

[0016] Under such conditions, since the one-way valve blocks the return of blood from the second stretch to the first stretch, there is an increase in pressure within the second stretch and where the outlet opening of the containment body is located.

[0017] Such overpressure conditions are not functional to the proper operation of the circulation circuit and it is necessary to quickly restore the predetermined pressure value.

[0018] Another condition of pressure imbalance can occur if the passage of blood inside the secondary suction line is prevented by an obstruction upstream of the connector.

[0019] In such conditions, the pump continues to suck air in until the vacuum is created along the second stretch and where the outlet opening is located.

[0020] This condition leads to the generation of negative pressure and, in this case too, it is necessary to quickly restore the predetermined pressure value in order to avoid causing harm to the patient.

[0021] Furthermore, under conditions of overpressure as well as under conditions of vacuum, the correct suction of blood and the relevant movement towards the reservoir is not guaranteed. of the Invention

[0022] The main aim of the present invention is to devise a connector for extracorporeal blood circulation circuits that allows for optimal compensation for pressure imbalances that may occur within the extracorporeal blood circuit to which it is connected.

[0023] Another object of the present invention is to devise a connector for extracorporeal blood circulation circuits that allows abnormal pressure conditions to be quickly restored in order to ensure the correct performance of the surgical operation on the patient.

[0024] A further object of the present invention is to devise a connector for extracorporeal blood circulation circuits that allows the performance of the blood recirculation circuit to which it is connected to be improved.

[0025] Another object of the present invention is to devise a connector for extracorporeal blood circulation circuits that allows the aforementioned drawbacks of the prior art to be overcome within the scope of a simple, rational, easy and effective to use solution that is also inexpensive.

[0026] The aforementioned objects are achieved by the present connector for extracorporeal blood circulation circuits having the characteristics of claim 1. Brief Description of the Drawings

[0027] Other characteristics and advantages of the present invention will become more apparent from the description of some preferred, but not exclusive, embodiments of a connector for extracorporeal blood circulation circuits, illustrated by way of an indicative, yet non-limiting example in the accompanying drawings, in which: Figure 1 is an axonometric view of a connector according to the invention and made according to a first embodiment;

[0028] Figure 2 is an axonometric and exploded view of the connector of Figure 1;

[0029] Figure 3 is a cross-sectional view of the connector in Figure 1 along the plane III-

[0030] III in Figure 1;

[0031] Figure 4 is a cross-sectional view of the connector in Figure 1 along the plane IV-

[0032] IV of Figure 1;

[0033] Figure 5 is a cross-sectional view of a connector according to the invention and made according to a second embodiment;

[0034] Figure 6 is a cross-sectional view of a connector according to the invention and made according to a third embodiment.

[0035] Embodiments of the invention

[0036] With particular reference to these figures, reference numeral 1 globally denotes a connector for extracorporeal blood circulation circuits.

[0037] The connector 1 comprises: at least one substantially hollow containment body 2 and provided with at least one inlet opening 3, couplable to a supply line of a blood stream, and at least one outlet opening 4 of the blood stream, couplable to a return line comprising at least one pumping device operable for the movement of the blood stream along a direction of circulation 5; at least one valve device 6 allocated internally to the containment body 2 and adapted to allow the flow of the blood stream along the direction of circulation 5 from the inlet opening 3 to the outlet opening 4.

[0038] The connector 1 is intended to be connected to a circuit for the extracorporeal blood circulation of a patient.

[0039] As is well known, the use of extracorporeal blood circulation circuits is necessary in various medical and hospital contexts wherein the heart function of a patient is temporarily suspended.

[0040] For example, extracorporeal blood circulation circuits can be used during cardiac surgery. Generally, extracorporeal blood circulation circuits comprise: a cannula connected to the patient’s circulatory system; a drainage line connected to a reservoir for containing a safety volume of blood during surgery; a (peristaltic / centrifugal) pumping unit; an oxygenator; a heat exchanger; optionally, an arterial filter; an arterial cannula connected to the patient’s aorta.

[0041] In addition, suction lines are also provided to drain bleeding that occurs in the heart or cardiac cavity during surgery, bringing it into the reservoir’s filtering systems.

[0042] The connector 1 is positioned along the aforementioned suction or intake line.

[0043] In detail, the blood suction or intake line comprises a first stretch, connected to the patient’s heart and to a tube connected to the inlet opening 3, and a second stretch, connected to the outlet opening 4 and to the pumping device.

[0044] The connector 1 is adapted to allow blood to stream from the first stretch to the second stretch and is adapted to prevent blood from streaming from the second stretch to the first stretch.

[0045] The containment body 2 of the connector 1, as can be seen from the figures, has a substantially elongated shape.

[0046] The inlet opening 3 and the outlet opening 4 are located at a respective end of the containment body 2 and are arranged centrally with respect to the axis of longitudinal development of the containment body 2 itself.

[0047] The containment body 2 internally bounds a housing compartment 7 wherein the valve device 6 is positioned.

[0048] With particular reference to the specific embodiment shown in the figures, the containment body 2 comprises a first shell element 8 and a second shell element 9 which are mutually associated with each other along their respective perimeter edges to bound the housing compartment 7.

[0049] The first shell element 8 comprises the inlet opening 3 and the second shell element 9 comprises the outlet opening 4.

[0050] The first shell element 8 and the second shell element 9 are mutually associated following the positioning of the valve device 6 between the same shell elements 8 and 9.

[0051] For example, the first shell element 8 is fastened to the second shell element 9 by ultrasonic welding.

[0052] Alternative embodiments of the connector 1 cannot however be ruled out, in which the first shell element 8 is fastened to the second shell element 9 using a different technology.

[0053] The first shell element 8 and the second shell element 9 are preferably made of polycarbonate.

[0054] Alternative embodiments of the connector 1 cannot, however, be ruled out wherein the first shell element 8 and the second shell element 9 are made of a different material.

[0055] The valve device 6 is of the one-way type and is positioned between the inlet opening 3 and the outlet opening 4.

[0056] The valve device 6 is adapted to allow the blood stream to flow from the inlet opening 3 to the outlet opening 4 and to prevent it from streaming from the outlet opening 4 to the inlet opening 3.

[0057] With particular reference to the preferred embodiment shown in the figures, the valve device 6 is of the flute-mouthpiece type.

[0058] The geometric configuration and function of a flute-mouthpiece one-way valve are considered to be state of the art and, therefore, known to those skilled in the art.

[0059] The end of the flute mouthpiece-shaped valve device 6 faces the outlet opening 4, so as to counteract the return of blood from the latter towards the inlet opening 3.

[0060] The containment body 2 comprises at least one through adjusting hole 10, 11 adapted to allow the flow of air between the outside and the inside of the containment body 2.

[0061] In detail, the at least one adjusting hole 10, 11 allows air to flow between the outside and the housing compartment 7.

[0062] As will be described in detail below, the at least one adjusting hole 10, 11 is adapted to allow air to escape from the housing compartment 7 in the event of overpressure and to allow air to enter the housing compartment 7 in the event of vacuum.

[0063] According to the invention, the connector 1 comprises adjusting means 12, 17, 18, 23 of the pressure within the containment body 2, adapted to adjust the stream of air flowing through the at least one adjusting hole 10, 11.

[0064] The adjusting means 12, 17, 18, 23 and the at least one adjusting hole 10, 11 operate in conjunction in maintaining a pressure value inside the containment body 2 substantially equal to a predetermined pressure value.

[0065] The predetermined pressure value is substantially equal to the pressure value measured inside the containment body 2 during normal and correct operation of the extracorporeal blood circulation circuit to which the connector 1 is connected. During the use of the extracorporeal blood circulation circuit, abnormal operating conditions may occur which can generate pressure deviations from the predetermined value inside the containment body 2.

[0066] The presence of a pressure different from the predetermined pressure value may prevent blood from being effectively taken and recirculated.

[0067] As will be detailed below, it is possible to have both overpressure conditions, i.e., higher pressure than the predetermined value, and vacuum conditions, i.e., lower pressure than the predetermined value.

[0068] The adjusting means 12, 17, 18, 23 with which the connector 1 according to the invention is provided operate in the event of such abnormal pressure conditions, thus restoring the predetermined pressure value inside the containment body 2. Usefully, the containment body 2 comprises at least one air vent hole 10 adapted to allow air to escape from the containment body 2 when the pressure value inside the containment body 2 is higher than the predetermined value.

[0069] With reference to the particular embodiment shown in the figures, the vent hole 10 is made where the second shell element 9 is located.

[0070] Advantageously, the valve device 6 comprises at least one tubular body 12, 13 defining a passage channel 15 for the blood stream and comprising: at least a first portion 12 facing towards the outlet opening 4; at least a second portion 13 made of an elastically deformable material and associated with the first portion 12 on the opposite side from the outlet opening 4.

[0071] The first portion 12 is adapted to close the vent hole 10 when the pressure inside the containment body 2 is substantially equal to or lower than the predetermined value and is adapted to open the vent hole 10 when the pressure inside the containment body 2 is higher than the predetermined value.

[0072] The adjusting means 12, 17, 18, 23 comprise the first portion 12.

[0073] The tubular body 12, 13 is movable, as a result of the pressure exerted on the valve device 6, between at least: a closing position, wherein the first portion 12 is positioned on top of the vent hole 10 to close it and the second portion 13 is stretched out; and an opening position, wherein the first portion 12 is spaced apart from the vent hole 10 to free it and the second portion 13 is compressed.

[0074] An overpressure condition within the containment body 2 may, for example, occur if the pumping device is mistakenly operated to push blood in a retrograde maimer.

[0075] In such circumstances, the blood present in the second stretch of the intake line is pushed into the containment body 2 through the outlet opening 4.

[0076] The valve device 6 prevents the flow of blood towards the inlet opening 3, thus generating a condition of overpressure inside the second stretch and the containment body 2.

[0077] The overpressure blood hits the valve device 6, particularly the first portion 12, causing the elastic compression of the second portion 13, which drags the first portion 12 therewith, moving the latter away from the vent hole 10, which is thus opened.

[0078] In this way, the pressurized air escapes from the containment body 2 through the vent hole 10, causing a gradual decrease in pressure inside the latter until the predetermined value is restored. During the gradual decrease in pressure inside the containment body 2, the thrust operating on the valve device 6 decreases and the second portion 13 stretches elastically until it returns to its initial conformation in which the first portion 12 closes the vent hole 10.

[0079] Conversely, if the pressure value inside the containment body 2 is substantially equal to or lower than the predetermined value, the first portion 12 keeps the vent hole 10 closed in order to prevent air from flowing between the outside and the containment body 2.

[0080] Preferably, the elastically deformable material with which the second portion 13 is made is silicone.

[0081] Still with reference to the preferred embodiment shown in the figures, the first portion 12 is also made of elastically deformable material.

[0082] Preferably, the first portion 12 is also made of silicone.

[0083] Advantageously, the second portion 13 is substantially shaped in a bellows-like maimer.

[0084] This particular technical expedient promotes the elastic deformation of the second portion 13 in the event of overpressure and the subsequent elastic return of the same second portion 13 to the undeformed condition.

[0085] In actual facts, the fact that the second portion 13 is substantially bellows-shaped promotes the movement of the tubular body 12, 13 from the closing position to the opening position and vice versa.

[0086] Usefully, the connector 1 comprises at least one filtering element 16 positioned where the vent hole 10 is located, which is permeable to the flow of air and impermeable to the blood stream.

[0087] This latter technical expedient allows only air to escape from the vent hole 10 but retains the blood inside the containment body 2.

[0088] Preferably, the filtering element 16 is of the hydrophobic type.

[0089] Alternatively, the filtering element 16 is of the oleophobic type.

[0090] As can be seen in the particular embodiment shown in Figures 1 to 4, the containment body 2 defines a fitting which communicates with the vent hole 10 in a fluid-operated manner, the filtering element 16 being inserted into this fitting. Usefully, the connector 1 comprises at least one sealing element 22 associated with the containment body 2 and adapted to prevent the filtering element 16 from being expelled from the containment body 2 during the escape of pressurized air from the vent hole 10.

[0091] Figure 5 shows a second embodiment of the connector 1, wherein components identical to the first embodiment have substantially the same reference numbers as the first embodiment, to whose detailed description reference is made in full. The second embodiment of the connector 1 differs from the first embodiment mainly in that the filtering element 16 is of the type of a hydrophobic or oleophobic membrane filter, which is associated, e.g. welded, externally to the containment body 2, where the vent hole 10 is located.

[0092] In this particular embodiment, the containment body 2 is not provided with a fitting.

[0093] The characteristics of the connector 1 set out and described below are to be considered common to both embodiments described above.

[0094] Advantageously, the containment body 2 comprises at least one air intake hole 11 adapted to allow air to enter the containment body 2 when the pressure value inside the containment body 2 is lower than the predetermined value.

[0095] With reference to the particular embodiment shown in the figures, the intake hole 11 is cut where the first shell element 8 is located.

[0096] Furthermore, the intake hole 11 is separate from the vent hole 10.

[0097] Conveniently, the valve device 6 comprises at least a third portion 14, associated with the second portion 13 on the opposite side from the first portion 12.

[0098] Advantageously, the valve device 6 comprises at least one plug body 17, 18 made of an elastically deformable material and associated with the third portion 14.

[0099] The plug body 17, 18 is adapted to close the intake hole 11 when the pressure inside the containment body 2 is substantially equal to or higher than the predetermined value and is adapted to open the intake hole 11 when the pressure inside the containment body 2 is lower than the predetermined value.

[0100] The adjusting means 12, 17, 18, 23 comprise the plug body 17, 18.

[0101] The valve device 6 is movable, as a result of the suction force exerted on the valve device 6, between at least: a closing configuration, wherein the third portion 14 is lowered and the plug body 17, 18 is compressed and is adapted to close the intake hole 11; and an opening configuration, wherein the third portion 14 is raised and the plug body 17, 18 is stretched out and is adapted to open the intake hole 11.

[0102] A condition of pressure decrease within the containment body 2 may, e.g., occur in the event of the intake or suction line, in the stretch between the suction site and the inlet opening 3, being obstructed (e.g., by foreign bodies taken from the surgical site or by a narrowing of the tube) and blood remains blocked therein.

[0103] In such circumstances, the pumping device continues to suck air in from the suction line until vacuum is created inside the stretch of the latter between the outlet opening 4 and the pumping device itself, thus creating a vacuum where the outlet opening 4 is located.

[0104] The aforementioned vacuum air sucks the plug body 17, 18 in, which elastically deforms and moves away from the intake hole 11.

[0105] The intake hole 11 is thus connected to the outside in a fluid-operated maimer and air can enter the containment body 2, thus causing a gradual increase in pressure inside the latter until the predetermined value is restored.

[0106] During the gradual increase in pressure, the intensity of the suction force operating on the plug body 17, 18 gradually decreases and the latter can progressively stretch out elastically until it returns to its initial shape wherein the plug body 17, 18 closes the intake hole 11.

[0107] Conversely, until the pressure value inside the containment body 2 reaches a value substantially equal to or greater than the predetermined value, the plug body 17, 18 closes the intake hole 11 in order to prevent air exchange between the containment body 2 and the outside.

[0108] Preferably, the elastically deformable material with which the third portion 14 is made is silicone.

[0109] With reference to the particular embodiment shown in the figures, the containment body 2 and, specifically, the first shell element 8, bounds an intake chamber 19 which communicates with the outside in a fluid-operated manner through the intake hole 11.

[0110] The third portion 14 and the plug body 17, 18 are adapted to separate the intake chamber 19 from the housing compartment 7 when the valve device 6 is in the closing configuration.

[0111] Conversely, when the valve device 6 is in the opening configuration, the intake chamber 19 is in fluidic communication with the housing compartment 7, so as to allow air to enter the latter.

[0112] Still with particular reference to the specific embodiment shown in the figures, the plug body 17, 18 comprises at least one flange portion 17, associated with the third portion 14.

[0113] Furthermore, the containment body 2 internally defines at least one abutment surface 20 inclined with respect to the axis of longitudinal development of the tubular body 12, 13.

[0114] The flange portion 17 abuts against the abutment surface 20 and deforms during the movement of the valve device 6 from the closing configuration to the opening configuration.

[0115] As can be seen from the figures, the flange portion 17 has a substantially platelike and circular shape and is arranged substantially centered with respect to the axis of longitudinal development of the tubular body 12, 13.

[0116] The first shell element 8 and the second shell element 9 bound, where their respective joining edges are located, a containment seat 21 adapted to contain the perimeter edge of the flange portion 17 and to retain the latter.

[0117] In particular, during the movement of the valve device 6 from the closing configuration to the opening configuration, the flange portion 17 remains blocked inside the containment seat 21 and deforms easily, thus abutting against the abutment surface 20.

[0118] The abutment surface 20 is defined inside the second shell element 9 and is inclined from the inlet opening 3 towards the outlet opening 4, i.e., along the way of the suction force generated inside the containment body 2 in the event of overpressure.

[0119] This particular technical expedient promotes the deformation of the flange portion 17 during the movement of the valve device 6 from the closing configuration to the opening configuration.

[0120] Advantageously, the plug body 17, 18 comprises at least one bellows-like portion

[0121] 18 associated with the flange portion 17 and positioned where the intake hole 11 is located in the closing configuration.

[0122] In detail, the bellows-like portion 18 is maintained compressed, thanks to a coupling by interference defined with the containment body 2, and closes the intake hole 11 when the valve device 6 is in the closing configuration.

[0123] Conversely, as soon as the valve device 6 is moved from the closing configuration to the opening configuration, the flange portion 17 is sucked in, causing the bellows-like portion 18 to stretch out which releases the intake hole 11.

[0124] The third portion 14 operates in conjunction with the bellows-like portion 18 and the flange portion 17 in closing the intake hole 11 and is adapted to limit blood stagnation inside the containment body 2 during normal operation of the connector 1.

[0125] It can be stated that, according to the first and second embodiments of the connector 1, the adjusting means 12, 17, 18, 23 are made in a single body piece with the valve device 6.

[0126] Figure 6 shows a third embodiment of the connector 1, wherein components identical to the first and to the second embodiments have the same reference numerals as the first and second embodiments, to which reference is made in full for a detailed description.

[0127] The third embodiment of the connector 1 differs from the first and second embodiments mainly in that the adjusting means 12, 17, 18, 23 comprise at least one valve element 23 associated with the containment body 2 where the intake hole 11 is located and selectively positionable at at least: a first position, wherein it is adapted to close the intake hole 11 and the pressure inside the containment body 2 is substantially equal to or higher than the predetermined pressure value; a second position, wherein it is adapted to open the intake hole 11 and the pressure inside the containment body 2 is lower than the predetermined pressure value.

[0128] The valve element 23 is of the one-way valve type and is movable from the first position to the second position as a result of the suction force operating on the valve element 23 itself in the event of the pressure inside the containment body 2 being lower than the predetermined value.

[0129] In detail, the valve element 23 is adapted to normally close the intake hole 11 and is adapted to open the latter only when the pressure in the containment body 2 is lower than the predetermined value.

[0130] As can be seen from Figure 6, the valve device 6 with which the connector 1 according to this third embodiment is provided lacks the bellows-like portion 18, which is structurally and functionally replaced by the valve element 23.

[0131] Furthermore, according to this particular embodiment, the containment body 2 lacks the intake chamber 19, and the intake hole 11 is directly connected / disconnected to the housing compartment 7 by the valve element 23.

[0132] Preferably, the connector 1 according to the aforementioned embodiment comprises connecting means 24 of the Luer lock type adapted to associate the valve element 23 with the containment body 2.

[0133] In detail, these connecting means 24 of the Luer lock type comprise a female connector that is co-molded with the containment body 2 and which is connectable to a male connector with which the valve element 23 is provided.

[0134] It can be stated that, according to the third embodiment of the connector 1, the adjusting means 12, 17, 18, 23 are separate, at least partly, from the valve device 6 and are not made in a single body piece with the latter.

[0135] It has, in practice, been ascertained that the described invention achieves the intended objects and, in particular, the fact should be emphasized that the connector according to the invention, thanks to the synergistic combination of the adjusting holes of the containment body and the adjusting means, allows the optimal operating conditions of the extracorporeal blood circuit to which it is connected to be quickly restored, especially in relation to the pressure value.

[0136] In this way, the connector according to the invention allows an optimal pressure condition to be maintained in the containment body so as to ensure the regular drainage of blood towards the reservoir, improving the overall performance of the circuit itself.

Claims

CLAIMS1) Connector (1) for extracorporeal blood circulation circuits, comprising: at least one substantially hollow containment body (2) and provided with at least one inlet opening (3), couplable to a supply line of blood stream, and at least one outlet opening (4) of said blood stream, couplable to a return line comprising at least one pumping device operable for the movement of said blood stream along a direction of circulation (5); at least one valve device (6) allocated internally to said containment body (2) and adapted to allow the flow of said blood stream along said direction of circulation (5) from said inlet opening (3) to said outlet opening (4); wherein said containment body (2) comprises at least one through adjusting hole (10, 11) adapted to allow the flow of air between the outside and the inside of said containment body (2); characterized by the fact that it comprises adjusting means (12, 17, 18, 23) of the pressure inside said containment body (2) which means are adapted to adjust the flow of air passing through said at least one adjusting hole (10, 11), said adjusting means (12, 17, 18, 23) and said at least one adjusting hole (10, 11) operating in conjunction in maintaining a pressure value inside said containment body (2) substantially equal to a predetermined pressure value.2) Connector (1) according to claim 1, characterized by the fact that said containment body (2) comprises at least one air vent hole (10) adapted to allow air to escape from said containment body (2) when said pressure value inside said containment body (2) is higher than said predetermined value.3) Connector (1) according to one or more of the preceding claims, characterized by the fact that said valve device (6) comprises at least one tubular body (12, 13) defining a passage channel (15) for said blood stream and comprising: at least a first portion (12) facing towards said outlet opening (4); at least a second portion (13) made of an elastically deformable material and associated with said first portion (12) on the opposite side from said outlet opening (4);wherein said first portion (12) is adapted to close said vent hole (10) when the pressure inside said containment body (2) is substantially equal to or lower than said predetermined value and is adapted to open said vent hole (10) when the pressure inside said containment body (2) is higher than said predetermined value, said adjusting means (12, 17, 18, 23) comprising said first portion (12).4) Connector (1) according to one or more of the preceding claims, characterized by the fact that said tubular body (12, 13) is movable, as a result of the pressure exerted on said valve device (6), between at least: a closing position, wherein said first portion (12) is positioned on top of said vent hole (10) to close it and said second portion (13) is stretched out; and an opening position, wherein said first portion (12) is spaced apart from said vent hole (10) to free it and said second portion (13) is compressed.5) Connector (1) according to one or more of the preceding claims, characterized by the fact that said second portion (13) is substantially shaped in a bellows-like maimer.6) Connector (1) according to one or more of the preceding claims, characterized by the fact that said containment body (2) comprises at least one filtering element (16) positioned where said vent hole (10) is located permeable to said flow of air and impermeable to said blood stream.7) Connector (1) according to one or more of the preceding claims, characterized by the fact that said filtering element (16) is of the hydrophobic type.8) Connector (1) according to one or more of the preceding claims, characterized by the fact that said containment body (2) comprises at least one air intake hole (11) adapted to allow the air to enter said containment body (2) when said pressure value inside said containment body (2) is lower than said predetermined value.9) Connector (1) according to one or more of the preceding claims, characterized by the fact that said valve device (6) comprises at least a third portion (14) associated with said second portion (13) on the opposite side from said first portion (12).10) Connector (1) according to one or more of the preceding claims, characterized by the fact that said valve device (6) comprises at least one plug body (17, 18) made of an elastically deformable material and associated with said third portion (14); wherein said plug body (17, 18) is adapted to close said intake hole (11) when the pressure inside said containment body (2) is substantially equal to or higher than said predetermined value and is adapted to open said intake hole (11) when the pressure inside said containment body (2) is lower than said predetermined value, said adjusting means (12, 17, 18, 23) comprising said plug body (17, 18).11) Connector (1) according to one or more of the preceding claims, characterized by the fact that said valve device (6) is movable, as a result of the suction force exerted on said valve device (6), between at least: a closing configuration, wherein said third portion (14) is lowered and said plug body (17, 18) is compressed and is adapted to close said intake hole (11); and an opening configuration, wherein said third portion (14) is raised and said plug body (17, 18) is stretched out and is adapted to open said intake hole (11).12) Connector (1) according to one or more of the preceding claims, characterized by the fact that said plug body (17, 18) comprises at least one flange portion (17) associated with said third portion (14).13) Connector (1) according to one or more of the preceding claims, characterized by the fact that said containment body (2) internally defines at least one abutment surface (20) inclined with respect to the axis of longitudinal development of said tubular body (12, 13), said flange portion (17) abutting against said abutment surface (20) and deforming during the movement of said valve device (6) from said closing configuration to said opening configuration.14) Connector (1) according to one or more of the preceding claims, characterized by the fact that said plug body (17, 18) comprises at least one bellows-like portion (18) associated with said flange portion (17) and positioned where said intake hole (11) is located in said closing configuration, said bellows-like portion (18) operating in conjunction with said third portion (14) in closing said intake hole (11).15) Connector (1) according to one or more of the preceding claims, characterized by the fact that said adjusting means (12, 17, 18, 23) comprise at least one valve element (23) associated with said containment body (2) where said intake hole (11) is located and selectively positionable at at least: a first position, wherein it is adapted to close said intake hole (11) and the pressure inside said containment body (2) is substantially equal to or higher than said predetermined pressure value; - a second position, wherein it is adapted to open said intake hole (11) and the pressure inside said containment body (2) is lower than said predetermined pressure value.

Citation Information

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