Device for extracorporeal blood treatment

Abstract

An apparatus for extracorporeal blood treatment comprises an extracorporeal blood circuit configured to be connected to a vascular access of a patient (P) or a blood circuit of a high blood flow machine (36). The control unit (100) is configured to check the connection of the extracorporeal blood circuit by performing: receiving a measured pressure from the pressure sensor (25, 26); detecting whether the extracorporeal blood circuit is a vascular access connected to the patient (P) or a blood circuit of a high blood flow machine (36) by performing an analysis on the measured pressure or a parameter related to the measured pressure; if a connection to the vascular access of the patient (P) and / or a connection to the blood circuit of the high blood flow machine (36) is detected, a signal is emitted.

Description

Technical Field

[0001] The present invention relates to a device for extracorporeal blood treatment, which is capable of detecting whether a corresponding extracorporeal blood circuit is connected to a patient's vascular access or a blood circuit of a high blood flow machine. The present invention also relates to a combination of the device for extracorporeal blood treatment and a high blood flow machine. The present invention is applicable to scenarios of medical devices and methods for extracorporeal blood treatment (for example, continuous renal replacement therapy (CRRT) for intensive care unit (ICU), medical devices and methods for blood perfusion or for therapeutic plasma exchange (TPE)). Background Art

[0002] The CRRT system is configured to provide treatment designed for patients in an acute disease state who may temporarily lose their renal function completely. The CRRT monitor should be able to provide various therapies, such as: ultrafiltration (UF), continuous venovenous hemofiltration (CCVH), continuous venovenous hemodiafiltration (CVVHDF), continuous venovenous hemodialysis (CCVHD). During treatment, blood flows into / out of the body, and the average blood flow in adults is usually between 100 ml / min and 250 ml / min, while the average blood flow in pediatric applications is less than 100 ml / min.

[0003] Blood perfusion is a process of passing blood through an adsorption system to remove specific toxic substances from the blood. The adsorption system can consist of a plastic housing or cartridge that contains particles allowing adsorption of molecules. During this treatment, blood flows into / out of the body, and the average blood flow is usually between 50 ml / min and 200 ml / min.

[0004] Therapeutic plasma exchange (TPE) (also known as plasmapheresis) is a process involving removing plasma from other components of the blood through a cell separator, discarding the plasma and replacing it with a physiological fluid. During this treatment, blood flows into / out of the body, and the average blood flow is usually between 100 ml / min and 250 ml / min.

[0005] The CRRT system, TPE system and blood perfusion system can be used in combination with a machine having a high blood flow circuit (such as extracorporeal membrane oxygenation (ECMO) or a cardiopulmonary machine for cardiopulmonary bypass) to support the cardiac and / or pulmonary function of patients with severe cardiac and / or respiratory failure.

[0006] In fact, acute kidney injury is common in patients receiving ECMO. The most common reasons for starting dialysis during ECMO are fluid overload (43%), prevention of fluid overload (16%), acute kidney injury (35%), and electrolyte disorders (4%). Early introduction of CRRT can prevent fluid overload and is often used in clinical practice.

[0007] The blood flow of an ECMO machine and other high blood flow machines (such as, an extracorporeal life support (ECLS) machine or a cardiopulmonary machine used for cardiopulmonary bypass) can be 2 L / min - 5 L / min, which is much higher than the blood flow of a CRRT system.

[0008] Some prior art documents disclose the combination of an ECMO machine and a device for extracorporeal blood treatment.

[0009] For example, document US2010288703A1 discloses an ECMO-CVVH (continuous venovenous hemofiltration) system, in which the CVVH device can be used as an independent CVVH device or within the CVVH part of a combined ECMO-CVVH system.

[0010] Document CN113230531A discloses the combination of ECMO and CRRT, in which the input end of CRRT is connected downstream of the oxygenator, and the output end of CRRT is connected upstream of the oxygenator. A pressure regulating device including a pressure sensor and a flow sensor is used to detect and control the flow and pressure between ECMO and CRRT. This combination is also disclosed by document US2022080093A1 and CN212817420U.

[0011] The device for extracorporeal blood treatment can be connected to an established ECMO circuit in various ways, so as to be able to operate extracorporeal blood treatment therapy under conditions of positive access pressure and / or negative return pressure, which are uncommon compared to the typical conditions of directly connecting the device for extracorporeal blood treatment to the patient's vascular access through a catheter.

[0012] These uncommon situations may cause the control program of the device for extracorporeal blood treatment based on the pressure monitoring method to operate abnormally or fail. For example, if the device for extracorporeal blood treatment is connected to an ECMO machine, detecting an access disconnection event or a return disconnection event through the pressure monitoring method may fail because, according to the operating ECMO pressure and no pressure drop at the connection point (no catheter pressure drop), the pressure change during disconnection may become very small. Summary of the Invention

[0013] In this context, the object of the present invention is to provide a technical solution capable of overcoming one or more of the above-mentioned drawbacks.

[0014] The object of the present invention is to ensure the compatibility of a device for extracorporeal blood treatment (such as CRRT, TPE, hemoperfusion) with a high blood flow machine (such as an extracorporeal membrane oxygenation (ECMO) machine or an extracorporeal life support (ECLS) machine or a cardiopulmonary machine for cardiopulmonary bypass), so that the device and the machine can simultaneously perform their respective therapies.

[0015] The object of the present invention is also to ensure that the device for extracorporeal blood treatment can operate properly both when connected to a patient's vascular access or to the blood circuit of a high blood flow machine.

[0016] The object of the present invention is also to improve the safety of the patient and the operator when the patient simultaneously undergoes dialysis and high blood flow treatment (such as ECMO).

[0017] The object of the present invention is also to ensure that the settings for extracorporeal blood treatment are correct both when the device is connected to a patient's vascular access and when the device is connected to a high blood flow machine.

[0018] The object of the present invention is also to adjust the operating parameters of the device, in particular the pressure operating range, according to the type of connection.

[0019] The object of the present invention is also to control the pressure monitoring system according to the type of connection, for example to ensure that a disconnection event is correctly detected or to prevent the triggering of unnecessary alarms.

[0020] According to the safety aspects discussed above, the object of the present invention is also to ensure that the blood access configuration made by the operator is correct.

[0021] The device for extracorporeal blood treatment according to one or more of the appended claims and / or one or more of the following aspects substantially achieves at least one of the above objects.

[0022] The combination of the device for extracorporeal blood treatment and a high blood flow machine according to one or more of the appended claims and / or one or more of the following aspects also substantially achieves one or more of the above objects.

[0023] The device disclosed herein allows for the automatic identification of the type of connection of its extracorporeal blood circuit, i.e., allows for the detection of whether the extracorporeal blood circuit is connected to a patient's vascular access or to the blood circuit of a high blood flow machine.

[0024] The devices and combinations according to aspects of the present invention are described below.

[0025] A first independent aspect relates to a device for extracorporeal blood treatment, comprising:

[0026] Treatment unit;

[0027] An extracorporeal blood circuit having a blood extraction line connected to the inlet of the treatment unit and a blood return line connected to the outlet of the treatment unit; the extracorporeal blood circuit being configured to be connected to a patient's vascular access or to a blood circuit of a high blood flow machine;

[0028] At least one pressure sensor configured to detect the pressure at at least one measurement location in the extracorporeal blood circuit;

[0029] A blood pump configured to control the blood flow through the extracorporeal blood circuit;

[0030] A control unit, connected to the blood pump and at least one pressure sensor, the control unit being configured to check the connection type of the extracorporeal blood circuit by performing the following procedure:

[0031] - Receiving at least one measured pressure from at least one pressure sensor;

[0032] - Detecting whether the extracorporeal blood circuit is connected to the blood circuit of a high blood flow machine by performing an analysis on at least one measured pressure or at least one parameter related to at least one measured pressure;

[0033] - Emitting at least one signal if and when a connection to the blood circuit of a high blood flow machine and / or a connection to the patient's vascular access is detected.

[0034] A second independent aspect relates to a method for detecting whether the extracorporeal blood circuit of a device for extracorporeal blood treatment is connected to a patient's vascular access or to the blood circuit of a high blood flow machine, the method comprising:

[0035] - Collecting at least one measured pressure from at least one pressure sensor, the at least one pressure sensor detecting the pressure at at least one measurement location in the extracorporeal blood circuit;

[0036] - Performing an analysis on at least one measured pressure or at least one parameter related to at least one measured pressure to detect whether the extracorporeal blood circuit is connected to the blood circuit of a high blood flow machine;

[0037] - Emitting at least one signal if and when a connection to the blood circuit of a high blood flow machine and / or a connection to the patient's vascular access is detected.

[0038] The devices and methods of aspects one and two are configured to distinguish a connection to a patient's vascular access from a connection to the blood circuit of a high blood flow machine by performing an analysis on at least one measured pressure or at least one parameter related to at least one measured pressure.

[0039] In a third aspect, the apparatus of aspect one is configured to perform the method of aspect two or the method of aspect two is performed by the apparatus of aspect one.

[0040] In a fourth aspect, the present invention also relates to a combination of a device for extracorporeal blood treatment and a high blood flow machine, wherein the device for extracorporeal blood treatment is according to at least one of aspect one or the following aspects.

[0041] In a fifth aspect according to any of the foregoing aspects, the device for extracorporeal blood treatment is a continuous renal replacement therapy (CRRT) device for intensive care treatment, such as being configured to provide various treatments (such as, CCVH, CVVHDF, CVVHD, SCUF), or is a hemoperfusion device or a therapeutic plasma exchange (TPE) machine.

[0042] In a sixth aspect according to any of the foregoing aspects, the high blood flow machine is an extracorporeal membrane oxygenation (ECMO) machine or an extracorporeal life support (ECLS) machine or a cardiopulmonary machine for cardiopulmonary bypass (CPB).

[0043] In a seventh aspect according to any of the foregoing aspects, the blood pump of the device for extracorporeal blood treatment is configured to generate an average blood flow of less than 250 ml / min, optionally less than 100 ml / min, optionally an average blood flow between 100 ml / min and 200 ml / min in the corresponding extracorporeal blood circuit during treatment.

[0044] In an eighth aspect according to any of the foregoing aspects, the pump of the high blood flow machine is configured to generate a blood flow of greater than 1 L / min, optionally greater than 2 L / min, optionally a blood flow between 2 L / min and 5 L / min in the corresponding blood circuit.

[0045] In a ninth aspect according to any of the foregoing aspects, the high blood flow machine comprises:

[0046] A blood circuit including a venous line and an oxygenation line, provided with a cannula configured to be placed in a vein or artery of a patient;

[0047] A pump, optionally a centrifugal pump;

[0048] An oxygenator;

[0049] wherein the pump is configured to pump blood through the blood circuit and the oxygenator according to the blood flow;

[0050] Optionally, the pump is set according to the pump speed, and the high blood flow machine includes a flow meter in the blood circuit to indicate the blood flow;

[0051] Optionally, the pump is controlled directly based on blood flow.

[0052] In a tenth aspect according to the aforementioned ninth aspect, the blood extraction line and the blood return line of the apparatus for extracorporeal blood treatment are connected to / connectable to the venous line and / or the oxygenation line of the high blood flow machine.

[0053] In an eleventh aspect according to any one of the preceding aspects, the at least one measured pressure comprises a cut-in pressure and / or a return pressure.

[0054] In a twelfth aspect according to the aforementioned eleventh aspect, the at least one pressure sensor comprises an access pressure sensor configured to measure an access pressure at a measurement position in the blood extraction line.

[0055] In a thirteenth aspect according to the preceding aspect eleven or twelve, the at least one pressure sensor comprises a return pressure sensor configured to measure a return pressure at a measurement position in the blood return line.

[0056] The present invention utilizes the sensor already equipped in the device for extracorporeal blood treatment to automatically identify the connection type. Therefore, the present invention does not lead to an increase in the complexity and production cost of the hardware of the device and / or the high blood flow machine.

[0057] In a fourteenth aspect according to any one of the preceding aspects, performing the analysis comprises comparing at least one measured pressure or at least one parameter related to at least one measured pressure with at least one reference value.

[0058] The pressure comparison used to distinguish between a connection to a patient's vascular access and a connection to the blood circuit of a high blood flow machine is relatively simple and reliable. The pressure measurement is also generally accurate and stable.

[0059] In a fifteenth aspect according to the fourteenth aspect above, the at least one measured pressure comprises a static pressure measured by the at least one pressure sensor when the blood flow through the extracorporeal blood circuit is zero.

[0060] In the fifteenth aspect according to the fifteenth aspect, the high blood flow machine is operating when the static pressure is measured by the at least one pressure sensor.

[0061] In a sixteenth aspect according to the aforementioned fifteenth aspect, the at least one reference value includes at least one lower limit pressure and at least one upper limit pressure.

[0062] In a seventeenth aspect according to the sixteenth aspect, the control unit is configured to execute the following program:

[0063] Receive static pressure;

[0064] Receive the lower limit pressure and the upper limit pressure;

[0065] Compare the static pressure with the lower limit pressure and the upper limit pressure.

[0066] In an eighteenth aspect according to the seventeenth aspect described above, if the static pressure exceeds the range between the lower limit pressure and the upper limit pressure, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of a high blood flow machine.

[0067] In a nineteenth aspect according to aspect fourteen in accordance with aspects eleven, twelve, and thirteen, at least one measured pressure includes a static return pressure and a static access pressure measured by an access pressure sensor and a return pressure sensor when the blood flow through the extracorporeal blood circuit is zero.

[0068] In a twentieth aspect according to aspect sixteen, in accordance with the nineteenth aspect described above, the control unit is configured to execute the following procedure:

[0069] Receive the static return pressure and the static access pressure;

[0070] Receive at least one lower limit pressure and at least one upper limit pressure; optionally, receive a return lower limit pressure and a return upper limit pressure and an access lower limit pressure and an access upper limit pressure;

[0071] Compare the static return pressure and / or the static access pressure with at least one lower limit pressure and at least one upper limit pressure; optionally, compare the static return pressure with the return lower limit pressure and the return upper limit pressure and / or compare the static access pressure with the access lower limit pressure and the access upper limit pressure.

[0072] In a twenty-first aspect according to the twentieth aspect described above, if the static return pressure and / or the static access pressure exceeds the range between at least one lower limit pressure and at least one upper limit pressure, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of a high blood flow machine.

[0073] In a twenty-second aspect according to aspect twenty or twenty-one, if the static return pressure and / or the static access pressure is within the range between at least one lower limit pressure and at least one upper limit pressure, the control unit checks:

[0074] Whether the difference between the static access pressure and the static return pressure is zero when the height of the measurement location of the access pressure performed by the access pressure sensor is the same as the height of the measurement location of the return pressure performed by the return pressure sensor; or

[0075] Is the difference between the static access pressure and the static return pressure equal to the hydrostatic bias, which results from the different heights of the measurement locations of the access pressure performed by the access pressure sensor and the return pressure performed by the return pressure sensor?

[0076] In a twenty-third aspect according to the foregoing aspect twenty-two, if the difference between the static access pressure and the static return pressure is not zero, or if the difference between the static access pressure and the static return pressure is not equal to the hydrostatic bias, taking into account measurement inaccuracies, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine.

[0077] In a twenty-fourth aspect according to the foregoing aspect twenty-two, if the difference between the static access pressure and the static return pressure is zero, or if the difference between the static access pressure and the static return pressure is equal to the hydrostatic bias, taking into account measurement inaccuracies, the control unit records that the extracorporeal blood circuit is connected to the patient's vascular access.

[0078] In a twenty-fifth aspect according to any one of the foregoing aspects twenty-one to twenty-four, at least one reference value further includes a lower limit error and an upper limit error to take into account measurement inaccuracies; optionally, the lower limit error is between -20 mmHg and -10 mmHg; optionally, the upper limit error is between +10 mmHg and +20 mmHg.

[0079] In a twenty-sixth aspect according to the foregoing aspect twenty-five, the control unit is configured to execute the following procedure: receive the lower limit error and the upper limit error, and if the static return pressure or the static access pressure is within the range between the lower limit pressure and the upper limit pressure, the control unit calculates the difference between the static access pressure and the static return pressure, or if the hydrostatic bias is to be considered, calculates the difference between the static access pressure, the static return and the hydrostatic bias, and compares the difference with the lower limit error and the upper limit error.

[0080] In a twenty-seventh aspect according to the foregoing aspect twenty-six, if the difference exceeds the range between the lower limit error and the upper limit error, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine.

[0081] In a twenty-eighth aspect according to the foregoing aspect twenty-six, if the difference is within the range between the lower limit error and the upper limit error, the control unit records that the extracorporeal blood circuit is connected to the patient's vascular access.

[0082] In a twenty-ninth aspect according to any one of the foregoing aspects one to fourteen, at least one parameter related to at least one measured pressure includes at least one catheter pressure drop coefficient, and wherein at least one reference value includes a pressure drop coefficient reference value.

[0083] In a thirtieth aspect according to the twenty-ninth aspect described above, the control unit is configured to execute the following program:

[0084] Receive a reference value of the pressure drop coefficient;

[0085] Calculate at least one catheter pressure drop coefficient.

[0086] In a thirty-first aspect according to the thirtieth aspect described above, if at least one catheter pressure drop coefficient is less than the reference value of the pressure drop coefficient, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine.

[0087] In a thirty-second aspect according to the thirtieth aspect described above, if at least one catheter pressure drop coefficient is greater than or equal to the reference value of the pressure drop coefficient, the control unit records that the extracorporeal blood circuit is connected to the vascular access of the patient.

[0088] In a thirty-third aspect according to the thirtieth aspect described above, at least one catheter pressure drop coefficient includes an access catheter pressure drop coefficient and a return catheter pressure drop coefficient.

[0089] In a thirty-fourth aspect according to the thirty-third aspect described above, if the access catheter pressure drop coefficient and the return catheter pressure drop coefficient are less than the reference value of the pressure drop coefficient, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine.

[0090] In a thirty-fifth aspect according to the thirty-third aspect described above, if the access catheter pressure drop coefficient and the return catheter pressure drop coefficient are greater than or equal to the reference value of the pressure drop coefficient, the control unit records that the extracorporeal blood circuit is connected to the vascular access of the patient.

[0091] In a thirty-sixth aspect according to the thirty-third aspect described above, if the access catheter pressure drop coefficient is greater than or equal to the reference value of the pressure drop coefficient and the return catheter pressure drop coefficient is less than the reference value of the pressure drop coefficient, or vice versa, the control unit records an uncertain connection state.

[0092] In a thirty-seventh aspect according to any one of the twenty-ninth to thirty-sixth aspects described above, the control unit is configured to calculate at least one catheter pressure drop coefficient by the following program:

[0093] Receive the static pressure measured by at least one pressure sensor when the blood flow through the extracorporeal blood circuit is zero;

[0094] Receive the pressure measured by at least one pressure sensor when the blood flow is stable and non-zero;

[0095] Receive the blood flow in the extracorporeal blood circuit;

[0096] Receive or calculate the blood viscosity;

[0097] Receive or calculate a function of the sectional pressure drop coefficient of a blood pipeline;

[0098] Calculate at least one catheter pressure drop coefficient based on the static pressure, pressure, blood flow rate, blood viscosity, and the sectional pressure drop coefficient.

[0099] It is more robust in the case of a coagulation event occurring in one or more pipelines according to the algorithms of the foregoing aspects 29 to 37.

[0100] In the thirty-eighth aspect, performing the analysis includes a first diagnostic step and a second diagnostic step, where the first diagnostic step includes any one of the foregoing aspects 15 to 28, and the second diagnostic step includes any one of the foregoing aspects 29 to 37, or vice versa.

[0101] Both the first diagnostic step and the second diagnostic step can be performed within a short time and within the first few minutes of extracorporeal blood treatment (e.g., CRRT treatment) to allow for timely correction. Using the first diagnostic step and the second diagnostic step makes the detection of the connection type more accurate.

[0102] In the thirty-ninth aspect according to any one of the foregoing aspects 1 to 13, performing the analysis includes: checking the correlation between the access pressure and the return pressure.

[0103] In the fortieth aspect according to the foregoing aspect 39, checking the correlation includes monitoring the access pressure and the return pressure over time during at least a part of the extracorporeal blood treatment.

[0104] In the forty-first aspect according to the foregoing aspect 40, if, while the blood flow rate through the extracorporeal blood circuit remains constant, the access pressure decreases and the return pressure increases, or the access pressure increases and the return pressure decreases, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of a high blood flow rate machine.

[0105] In the forty-second aspect, performing the analysis includes an additional diagnostic step performed after the main diagnostic step, the main diagnostic step including any one of the foregoing aspects 15 to 28 and / or any one of the foregoing aspects 29 to 37, and the additional diagnostic step including any one of the foregoing aspects 39 to 41.

[0106] In the forty-fourth aspect according to aspect 42, if the main diagnostic step provides an uncertain connection state, the additional diagnostic step is performed.

[0107] In the forty-fifth aspect according to any one of the foregoing aspects 1 to 44, the control unit is configured to check the connection type when the extracorporeal blood treatment is started or restarted and / or during the extracorporeal blood treatment process.

[0108] In a forty-fifth aspect, the checking of the connection type can be repeated during an extracorporeal blood treatment process in the following situations:

[0109] - After specific situations where a change in the blood circuit is suspected (e.g., after a "long" blood flow stop (e.g., > 1 minute) (whether triggered by an alarm or not), a change occurs in the access pressure operating point and the return pressure operating point);

[0110] - Periodically.

[0111] If performed when restarting the treatment after a recirculation step, such a sequence can be used to change the blood circuit configuration.

[0112] In a forty-sixth aspect according to any one of the foregoing aspects one to forty-five, emitting at least one signal includes: emitting a warning signal configured to alert the operator of the detected connection type; optionally, the control unit is configured to issue an inquiry to the operator, asking the operator to identify and input the connection type; optionally, if the input configuration is different from the detected configuration, the control unit is configured to warn the operator and / or stop / prevent the device / process.

[0113] In a forty-seventh aspect according to any one of the foregoing aspects one to forty-six, emitting at least one signal includes: setting the operating parameters of the device according to the detected connection type or notifying the operator of the operating parameters according to the detected connection type.

[0114] In a forty-eighth aspect according to aspect nine or other aspects when according to aspect nine according to any one of the other aspects, the blood extraction line and the blood return line of the device for extracorporeal blood treatment are connected to different positions of the venous line of a high blood flow machine, i.e., different positions of the line upstream of the oxygenator in the blood circuit of the high blood flow machine.

[0115] In a forty-ninth aspect according to the foregoing aspect forty-eight, the blood extraction line is connected to the venous line at a connection position downstream of the connection of the blood return line; optionally, the connection position of the blood extraction line and the connection position of the blood return line are upstream of the pump of the high blood flow machine; optionally, the connection position of the blood extraction line is downstream of the pump of the high blood flow machine, and the connection position of the blood return line is upstream of the pump of the high blood flow machine.

[0116] In a fiftieth aspect according to the foregoing aspect forty-eight, the blood extraction line is connected to the venous line at a connection position upstream of the connection of the blood return line; optionally, the connection position of the blood extraction line and the connection position of the blood return line are between the pump and the oxygenator of the high blood flow machine.

[0117] In a fifty-first aspect according to aspect nine or other aspects, when according to aspect nine and in any one of the other aspects, the blood extraction line of the device for extracorporeal blood treatment is connected to the oxygenation line of the high blood flow machine, and the blood return line of the device for extracorporeal blood treatment is connected to the venous line of the high blood flow machine; optionally, the connection position of the blood return line is upstream of the pump of the high blood flow machine; optionally, the connection position of the blood return line is between the pump and the oxygenator of the high blood flow machine.

[0118] In a fifty-second aspect according to the foregoing aspect fifty-one, the oxygenator has an inlet port and an outlet port; the blood return line of the device for extracorporeal blood treatment is connected to the outlet port, and the blood extraction line of the device for extracorporeal blood treatment is connected to the inlet port.

[0119] In a fifty-third aspect according to aspect forty-seven, the operating parameters include:

[0120] Operating parameters according to a first value or a first range when a connection to the patient's vascular access is detected;

[0121] Operating parameters according to a second value or a second range when a connection to the blood circuit of the high blood flow machine is detected;

[0122] Wherein at least one of the first value or the first range is different from at least one of the second value or the second range.

[0123] In a fifty-fourth aspect according to the foregoing aspect fifty-three, the operating parameters include:

[0124] Operating pressure, optionally, access operating pressure and return operating pressure; and / or

[0125] Alarm pressure, optionally, access alarm pressure and return alarm pressure.

[0126] In a fifty-fifth aspect according to the foregoing aspect fifty-four, the first range of the access operating pressure is between -250 mmHg and +20 mmHg; the first range of the return operating pressure is between -20 mmHg and +350 mmHg; the second range of the access operating pressure is between -250 mmHg and +400 mmHg; the second range of the return operating pressure is between -250 mmHg and +400 mmHg.

[0127] In a fifty-sixth aspect according to the foregoing aspect fifty-four, the first access occlusion alarm threshold is P < -250 mmHg; the first return occlusion alarm threshold is P > +350 mmHg; the second access occlusion alarm threshold is P < -250 mmHg; the second return occlusion alarm threshold is P > -400 mmHg or P increase > 200 mmHg.

[0128] In a fifty-seventh aspect according to any one of the foregoing aspects one to fifty-six, the vascular access device is arranged to connect a blood draw line and a blood return line to a patient's vascular access; optionally, the vascular access device includes a double-lumen catheter or two catheters or needle tips.

[0129] In a fifty-eighth aspect according to any one of the foregoing aspects one to fifty-six, a connection port (e.g., a Luer lock) is arranged to connect a blood draw line and a blood return line to a blood circuit of a high blood flow machine.

[0130] In a fifty-ninth aspect according to the foregoing aspect fifty-seven or fifty-eight, the blood draw line and the blood return line include respective connectors for connecting to a vascular access device or a blood circuit of a high blood flow machine.

[0131] In a sixtieth aspect according to the foregoing aspect fifty-three, a blood warming device is coupled to or configured to be coupled to a blood circuit of a device for extracorporeal blood treatment, and / or a fluid warmer is coupled to or configured to be coupled to one or more of the pump lines and / or the dialysis lines; wherein, the arrangement of the device according to the detected connection type includes:

[0132] If a connection to a patient's vascular access is detected, the blood warming device and / or the fluid warmer is enabled;

[0133] If a connection to a blood circuit of a high blood flow machine is detected, the blood warming device and / or the fluid warmer is disabled.

[0134] Disabling the blood warming device and / or the fluid warmer allows meeting the requirement of limiting current leakage. BRIEF DESCRIPTION OF THE DRAWINGS

[0135] Aspects of the present invention are shown in the drawings, which are provided by way of non-limiting examples, wherein:

[0136] Figure 1 A schematic diagram of a device for extracorporeal blood treatment connected to a patient is shown;

[0137] Figure 2 A side view schematic diagram of the device for extracorporeal blood treatment of Figure 1 is shown;

[0138] Figure 3 A combination of the device for extracorporeal blood treatment of Figure 1 and Figure 2 with a high blood flow machine is shown;

[0139] Figures 4 to 6 Different connections between the device for extracorporeal blood treatment and the high blood flow machine are shown;

[0140] Figure 7A shows a Figure 2 detailed enlarged view of an element of a device for extracorporeal blood treatment;

[0141] Figure 7B shows a Figure 3 magnified detail of a combination;

[0142] Figure 8 is a flowchart showing a method for detecting the connection type of a device for extracorporeal blood treatment;

[0143] Figure 9 is a flowchart showing another method for detecting the connection type of a device;

[0144] Figure 10 Schematically shows a high blood flow machine to be combined with a device for extracorporeal blood treatment. Detailed Description

[0145] Device for extracorporeal blood treatment

[0146] Figure 1 Schematically shows a device 1 for extracorporeal blood treatment in the figure. The device 1 is a continuous renal replacement therapy (CRRT) device for intensive care treatment, which is configured to provide various treatments, such as CCVH, CVVHDF, CVVHD, SCUF, for example.

[0147] In other embodiments not depicted in the drawings, the device 1 for extracorporeal blood treatment can be a blood perfusion machine (adsorber) or a machine for therapeutic plasma exchange (TPE).

[0148] The device 1 includes a processing unit 2, which is a filtration unit in the embodiment of the figure. It has a main chamber 3 and a secondary chamber 4 separated by a semipermeable membrane 5. According to the treatment, the semipermeable membrane 5 of the processing unit 2 can be selected to have different characteristics and performances.

[0149] The blood circuit is coupled to the main chamber 3 of the processing unit 2. The blood circuit includes a blood extraction line 6 connected to the inlet 3a of the main chamber 3 and a blood return line 7 connected to the outlet 3b of the main chamber 3. The blood extraction line 6 and the blood return line 7 are configured to be connected to the vascular access of a patient "P".

[0150] In use, the blood extraction line 6 and the blood return line 7 are connected to the vascular access of the patient "P". Specifically, the blood extraction line 6 and the blood return line 7 are connected to a vascular access device 400 which is then placed in fluid communication with the patient's "P" vascular system such that blood can be withdrawn through the blood extraction line 6, flow through the main chamber 3, and then return to the patient's vascular system through the blood return line 7. The vascular access device 400 can include two catheters placed in the patient's (one or more) central veins. The needle end can be used for other types of devices, such as TPE.

[0151] An air detector (not shown) and an air separator (e.g., degassing chamber 8) can be present on the blood return line 7. Additionally, a monitoring valve 9 can be present on the blood return line 7, downstream of the degassing chamber 8.

[0152] The blood flow through the blood circuit is controlled by a blood pump 10 (e.g., a peristaltic blood pump) acting on either the blood extraction line 6 or the blood return line 7. Figure 1 An embodiment shows the blood pump 10 coupled to the pump section of the blood extraction line 6.

[0153] The dialysis circuit is connected to the secondary chamber 4 of the processing unit 2 and includes a dialysis line 11 connected to the inlet 4a of the secondary chamber 4 and an effluent line 12 connected to the outlet 4b of the secondary chamber 4 and connected to a discharge (not shown).

[0154] An effluent pump 13 is located on the effluent line 12 and is capable of recovering fluid from the secondary chamber 4. The dialysis line 11 is connected to a source 14 of fresh dialysis fluid, e.g., a bag or a preparation device, and a dialysis pump 15 is located on the dialysis line 11 and is capable of pumping fluid into the secondary chamber 4.

[0155] The device 1 also includes an infusion circuit which includes at least one infusion line. Figure 1 The infusion circuit shown in an embodiment includes a pre - blood - pump line 16, a pre - infusion line 17, and a post - infusion line 18.

[0156] The pre - blood - pump line 16 is connected to the blood extraction line 6 upstream of the blood pump 10 and is connected to a first source 19 of infusion fluid, e.g., a bag. A pre - blood - pump 20 is located on the pre - blood - pump line 16 and is capable of pumping fluid from the first source 19 into the blood circuit.

[0157] The pre - infusion line 17 is connected to the blood extraction line 6 downstream of the blood pump 10 and upstream of the processing unit 2 and is connected to a second source 21 of infusion fluid, e.g., a bag. A pre - infusion pump 22 is located on the pre - infusion line 17 and is capable of pumping fluid from the second source 21 into the blood circuit.

[0158] The post-infusion line 18 is connected downstream of the processing unit 2 to the blood return line 7 and to a third source 23 of infusion fluid, e.g., a bag. A post-infusion pump 24 is located on the post-infusion line 18 and is capable of pumping fluid from the third source 23 into the blood circuit.

[0159] The device 1 may also include one or more auxiliary lines (not shown) and a pump or syringe, the one or more auxiliary lines being connected to the blood circuit and a source of at least one compensating substance (e.g., calcium or heparin) or anticoagulant, the pump or syringe being configured to deliver a flow of the compensating substance (e.g., calcium or heparin, etc.).

[0160] The access pressure sensor 25 is configured to detect the pressure at the measurement location in the blood extraction line 6. The return pressure sensor 26 is configured to detect the pressure at the measurement location in the blood return line 7. The access pressure sensor 25 and the return pressure sensor 26 may include pressure pods in the blood extraction line 6 and the blood return line 7. The return pressure sensor 26 may be operatively coupled to the degassing chamber 8, as Figure 1 shown.

[0161] The filter pressure sensor 2a is located immediately upstream of the inlet 3a of the main chamber 3 and is configured to measure the pressure required to drive the blood through the processing unit 2. The effluent pressure sensor 12a is located immediately downstream of the outlet 4b of the secondary chamber 4 and is configured to measure the pressure required to drive / extract the ultrafiltrate from the blood.

[0162] The device 1 may also include a blood warming device "W" which is coupled to the blood return line 7 and is configured to warm the blood before it is returned to the patient "P". The device 1 may also include a fluid warmer (not shown in the figure) which is coupled to one or more of the dialysis line 11, the pre-blood pump line 16, the pre-infusion line 17, the post-infusion line 18 and is configured to warm the corresponding fluid.

[0163] The control unit 100 is connected to and controls the blood pump 10, the dialysis pump 15, the effluent pump 13, the pre-blood pump 20, the pre-infusion pump 22 and the post-infusion pump 24 to regulate the blood flow rate "Q" in the blood circuit b", the dialysis flow rate through the dialysis line 11, the effluent flow rate through the effluent line 12, the infusion flow rate through the pre - blood pump line 16, the infusion flow rate through the pre - infusion line 17, and the infusion flow rate through the post - infusion line 18. By controlling the dialysis flow rate through the dialysis line 11 and / or the effluent flow rate through the effluent line 12, the control unit 100 is further configured to control / regulate the filtration flow rate in the treatment unit 2 (by controlling the dialysis pump 15 and the effluent pump 13) and / or the patient fluid removal rate (also by controlling the pre - blood pump 20, the pre - infusion pump 22, and the post - infusion pump 24).

[0164] The blood pump 10 controlled by the control unit 100 is configured to generate an average blood flow rate "Q" between 100 ml / min and 250 ml / min in the extracorporeal blood circuit during adult treatment b ", and generate an average blood flow rate "Q" of less than 100 ml / min in the extracorporeal blood circuit in pediatric applications b ".

[0165] The control unit 100 is also connected to an access pressure sensor 25, a return pressure sensor 26, a filter pressure sensor 2a, and an effluent pressure sensor 12a to receive signals related to the pressure values from these sensors 2a, 12a, 25, 26. The access pressure sensor 25, the return pressure sensor 26, and the filter pressure sensor 2a provide signals related to the pressure in the extracorporeal blood circuit to the control unit 100.

[0166] The control unit 100 is also connected to and controls a blood warming device "W" and a fluid warmer.

[0167] The control unit 100 can be an electronic control unit including at least a CPU, a memory, and an input / output device. The control unit 100 includes or is connected to an interface 110, which is configured to display data and / or allow an operator to input data. For example, the interface includes a display (e.g., a touch screen) and / or buttons or a keyboard.

[0168] The device 1 can include a processor 200 and an integrated disposable kit configured to be coupled to the processor 200. The profile of the processor 200 is schematically shown in Figure 2 ".

[0169] The processor 200 includes the above - mentioned blood pump 10, effluent pump 13, dialysis pump 15, pre - blood pump 20, pre - infusion pump 22, post - infusion pump 24, control unit 100 with an interface 110, and flow sensors.

[0170] The processor 200 may further include an access pressure sensor 25 and a return pressure sensor 26, or the access pressure sensor 25 and the return pressure sensor 26 may be part of an integrated disposable kit. The processor 200 further includes all other elements and / or devices configured to accommodate and hold the components of the integrated disposable kit.

[0171] The integrated disposable kit includes a processing unit 2, a blood circuit, an effluent line 12, a dialysis line 11, and infusion lines 16, 17, 18 grouped together or connected together before use.

[0172] When the integrated disposable kit is installed on the processor 200, the measurement locations of the access pressure sensor 25 and the return pressure sensor 26, or the access pressure sensor 25 and the return pressure sensor 26, are in fixed positions on the frame 300 of the processor 200 and at a predefined height above the ground.

[0173] A section 27 of the blood extraction line 6 extends from the access pressure sensor 25 on the processor 200 to the vascular access device 400 and to the patient "P" being treated. A section 28 of the blood return line 7 extends from the return pressure sensor 26 on the processor 200 to the vascular access device 400 and to the patient "P".

[0174] As Figure 2 shown, the patient "P" being treated lies on a bed 29, and the height at which the vascular access device 400 is placed may be different from the height of the location where the access pressure measurement is performed by the access pressure sensor 25 and the height of the location where the return pressure measurement is performed by the return pressure sensor 26, and may vary relative to the heights of these two measurement locations because the height of the bed is typically adjustable and / or the patient "P" may move or be moved.

[0175] Vascular access device

[0176] The vascular access device 400 shown in FIG. 7 is a central double-lumen venous catheter (CVC) configured to be placed in a large central vein of the patient "P", e.g., in the neck (internal jugular vein).

[0177] The vascular access device 400 is a double-lumen catheter and includes an extraction section 30 defining an extraction lumen and a return section 31 defining a return lumen. Distal portions of the extraction section 30 and the return section 31 are respectively provided with a distal tip 32 of the extraction section 30 and a distal tip 33 of the return section. The distal portions of the extraction section 30 and the return section 31 are paired and configured to be placed within the large central vein. The proximal portions of the extraction section 30 and the return section 31 are separate and configured to be held outside the patient.

[0178] The proximal part is respectively provided with a withdrawal port 34 and a return port 35. The withdrawal port 34 is connected to or configured to be connected to a connector 6a of a blood withdrawal pipeline 6, and the return port 35 is connected to or configured to be connected to a connector 7a of a blood return pipeline 7, as Figure 3 shown, and allows an extracorporeal blood circuit to be connected to the vascular system of a patient "P". The connectors and the corresponding ports can be Luer locks.

[0179] In combination with an extracorporeal membrane oxygenation (ECMO) machine

[0180] In Figure 3 it, a device 1 for extracorporeal blood treatment is coupled to a high blood flow machine 36.

[0181] For example, the high blood flow machine 36 is an extracorporeal membrane oxygenation (ECMO) machine. ECMO is an extracorporeal technique that provides long-term respiratory (venovenous (V-V) ECMO and venoarterial (V-A) ECMO) and optional cardiac (V-A ECMO)) support for people whose cardiopulmonary systems are unable to provide sufficient amounts of gas exchange or perfusion to sustain life. The techniques used for ECMO mainly originate from cardiopulmonary bypass, which provides short-term support in the case of a stopped self-circulation. Different from cardiopulmonary bypass machines designed for short-term use (e.g., during cardiac surgery), ECMO machines can provide long-term cardiopulmonary support over periods of hours, days, or even weeks, allowing the patient's cardiopulmonary systems time to heal and regain function.

[0182] The structure of the high blood flow machine 36 itself is known and is only schematically shown in Figure 3 it.

[0183] The high blood flow machine 36 includes: a venous pipeline 37 having a venous access cannula for draining venous blood, a pump 38 (e.g., a small volume centrifugal pump), an oxygenator 39, an ultrasonic sensor (not shown in the figure) for measuring blood flow rate and serving as a bubble detector, an oxygenated pipeline 40 returning to the patient, and a return (arterial) cannula that returns to the internal jugular vein or femoral vein in the case of venovenous ECMO (VV-ECMO), or returns to the aorta in the case of venoarterial ECMO (VA-ECMO). The venous pipeline 37 and the oxygenated pipeline 40 are part of the blood circuit of the high blood flow machine 36. The venous pipeline 37 extends from the patient "P" to the oxygenator 39. The oxygenated pipeline 40 extends from the oxygenator 39 back to the patient "P".

[0184] The high blood flow machine 36 may include its own control unit (not shown) that is connected to the pump 38 and the ultrasonic sensor and is configured to control the pump 38. The pump 38 controlled by the respective control unit is configured to generate an average blood flow “Q2b” between 2 L / min and 5 L / min in the blood circuit of the high blood flow machine 36, which average blood flow “Q2b” is much higher than the blood flow “Q b ”

[0185] The pump 38 is set according to the pump speed, and the high blood flow machine 36 includes a flow meter (not shown) in the blood circuit to inform the control unit of the blood flow. The control unit adjusts the pump speed according to the blood flow from the flow meter. In other embodiments, the pump 38 may be directly controlled according to the blood flow.

[0186] The device 1 for extracorporeal blood treatment is combined with the high blood flow machine 36 by connecting the blood extraction line 6 and the blood return line 7 to the blood circuit of the high blood flow machine 36.

[0187] The blood circuit of the high blood flow machine 36 includes ( Figure 7B ) a first connection port 41 of the connector 6 for connecting to the blood extraction line 6 and a second connection port 42 of the connector 7a for connecting to the blood return line 7. The connectors and the corresponding ports may be Luer locks.

[0188] In Figure 3 and Figure 7B embodiments, both the blood extraction line 6 and the blood return line 7 of the device 1 are connected to the venous line 37 of the high blood flow machine 36. The blood extraction line 6 is connected between the pump 38 and the oxygenator 39, and the blood return line 7 is connected upstream of the pump 38. According to a variant embodiment (not shown), the oxygenator 39 has an inlet port and an outlet port, and the blood return line 7 of the device 1 is connected to the outlet port, while the blood extraction line 6 of the device 1 is connected to the inlet port.

[0189] According to a variant embodiment (see the elements shown by the dashed lines in Figure 3 and Figure 7B ), the blood extraction line 6 of the device 1 is connected upstream of the pump 38 between the second connection port 42 and the pump 38.

[0190] In Figure 4 embodiments, both the blood extraction line 6 and the blood return line 7 of the device 1 are connected to the venous line 37 of the high blood flow machine 36 between the pump 38 and the oxygenator 39.

[0191] In Figure 5In an embodiment, the blood extraction line 6 of the device 1 for extracorporeal blood treatment is connected to the oxygenation line 40 of the high blood flow machine 36, and the blood return line 7 of the device 1 for extracorporeal blood treatment is connected to the venous line 37 of the high blood flow machine 36. The connection position of the blood return line 7 is upstream of the pump 38 of the high blood flow machine 36.

[0192] In Figure 6 an embodiment, the connection position of the blood return line 7 of the device 1 is between the pump 38 and the oxygenator 39 of the high blood flow machine 36.

[0193] In other embodiments, other high blood flow machines 36 may be combined with the device 1. For example, the high blood flow machine 36 may be an extracorporeal life support (ECLS) machine or a cardiopulmonary machine for cardiopulmonary bypass (CPB).

[0194] Figure 10 A known cardiopulmonary bypass (CPB) or cardiopulmonary machine is shown. The cardiopulmonary bypass (CPB) includes a venous line 37, a pump 38, an oxygenator 39, and an oxygenation line 40, similar to the ECMO in the previous figures. In Figure 10 it, the venous line 37 is connected to the inferior vena cava of the heart H, and the oxygenation line 40 is connected to the proximal aorta.

[0195] The cardiopulmonary bypass (CPB) further includes: a venous reservoir 43, positioned along the venous line 37 and between the heart H and the pump 38; a heat exchanger 44, placed on the oxygenation line 40 and between the oxygenator 39 and the heart H; an arterial filter 45, placed between the heat exchanger 44 and the heart H. The cardiopulmonary bypass (CPB) further includes a cardiotomy circuit 46 configured for aspiration during cardiac surgery. The cardiotomy circuit 46 includes a cardiotomy reservoir 47 and cardiotomy blood pumps 48, 49. The cardiopulmonary bypass (CPB) further includes a cardioplegia circuit 50 configured for delivering a cardioplegic fluid solution for protecting the heart H during cardiopulmonary bypass. The cardioplegia circuit 50 includes a cardioplegia pump 51, a cardioplegia solution bag 52, and a cardioplegia heat exchanger 53 for cooling the fluid solution.

[0196] As Figure 10 shown, the blood extraction line 6 of the device 1 may be connected to the oxygenation line 40 between the oxygenator 39 and the heat exchanger 44. The blood return line 7 of the device 1 may be connected to the venous line 37 between the heart H and the venous reservoir 43. Alternatively, the blood return line 7 may be connected to the venous reservoir 43.

[0197] Detect connection type

[0198] According to the method of the present invention, the control unit 100 of the device 1 for extracorporeal blood treatment is configured and / or programmed to detect whether the extracorporeal blood circuit of the device 1 is connected to a vascular access of a patient "P" (as Figure 1 and Figure 2 shown) or to the blood circuit of a high blood flow machine 36 (as Figures 3 to 6 and Figure 10 shown). In the case of detecting the connection type, the control unit 100 issues one or more signals.

[0199] The identification of the connection type can be used to automatically set the operating parameters of the device 1 for extracorporeal blood treatment and / or to alert the operator whether the manually input connection type is correct. Thus, the signal issued can be a warning signal configured to alert the operator of the detected connection type, and / or the signal issued can be configured to automatically set the device according to the detected connection type.

[0200] For example, after the extracorporeal blood circuit is mechanically connected to the vascular access device 400 or the high blood flow machine 36, the operator inputs the treatment prescription parameters and the connection type (vascular access device 400 or high blood flow machine 36) through the interface 110. The control unit 100 can also issue an inquiry to the operator, asking him to identify and input the connection type.

[0201] Then, the control unit 100 runs a routine according to the algorithm discussed below to identify the connection type, and can confirm to the operator that the connection type is correct, or warn the operator if the detected connection does not match the connection input by the operator, so that the operator can change the settings of the device 1.

[0202] In other embodiments, once the connection type is identified, the control unit 100 can automatically set the device 1 according to the detected connection, and / or can stop the device if the detected connection does not match the connection input by the operator.

[0203] The detection of the connection type is based on the pressure collected or measured from one or more pressure sensors in the extracorporeal blood circuit of the device 1, and an analysis is performed on the collected or measured pressure.

[0204] Algorithm 1

[0205] According to the first example algorithm, consider an embodiment of the device 1 in which the measurement positions of the access pressure sensor 25 and the return pressure sensor 26 are at the same height, and the hydrostatic bias is zero or negligible.

[0206] The high blood flow machine 36 (ECMO system) is a life support system and is assumed to be operating permanently.

[0207] Before starting or restarting CRRT treatment by device 1, and when the blood pump 10 is not running and the blood flow "Q b " is zero, the control unit 100 measures the static access pressure "P acc_Qb0 " in the blood extraction line 6 and the static return pressure "P ret_Qb0 " in the blood return line 6 by accessing the pressure sensor 25 and the return pressure sensor 26.

[0208] Then, the control unit 100 compares the static return pressure "P ret_Qb0 " with the lower limit pressure "Lvasc min " and the upper limit pressure "Lvasc max ":

[0209] If P ret_Qb0 <= Lvasc min or P ret_Qb0 >= Lvasc max

[0210] Then the control unit 100 records that the extracorporeal blood circuit of device 1 is connected to the blood circuit of the high blood flow machine 36;

[0211] If Lvasc min < P ret_Qb0 < Lvasc max

[0212] Then the control unit 100 checks whether the static access pressure "P acc_Qb0 " is the same as the static return pressure "P ret_Qb0 " by calculating the difference between the static access pressure "P acc_Qb0 " and the static return pressure "P ret_Qb0 " (P acc_Qb0 - P ret_Qb0 ) and comparing the difference with the lower limit error "-E" and the upper limit error "+E" ("+E and -E" are used to account for measurement inaccuracies):

[0213] If (P acc_Qb0- P ret_Qb0 ) <= -E or

[0214] (P acc_Qb0- P ret_Qb0 ) >= +E

[0215] Then the control unit 100 records that the extracorporeal blood circuit of device 1 is connected to the blood circuit of the high blood flow machine 36;

[0216] If -E < (P acc_Qb0- P ret_Qb0)<+E

[0217] Then, the control unit 100 records that the extracorporeal blood circuit of device 1 is connected to the vascular access of patient "P".

[0218] This first example algorithm will return the pressure "P ret_Qb0 " and compare it with the lower limit pressure "Lvasc min " and the upper limit pressure "Lvasc max ". In any case, the access pressure "P acc_Qb0 " can also be used, depending on which pressure measurement is more accurate and stable for device 1.

[0219] The lower limit pressure "Lvasc min " and the upper limit pressure "Lvasc max " for considering the offset pressure compatible with the vascular blood access depend on the device (e.g., pressure measurement location and measurement accuracy), the central venous pressure of patient "P", and the position of patient "P". In a device where the height of the pressure measurement location is about 120 cm, these limits can be set to Lvasc min = -20 mmHg and Lvasc max = +10 mmHg. The acceptable error "E" when comparing the static access pressure and the static return pressure can be about 15 mmHg.

[0220] According to a variant of the first example algorithm, the hydrostatic bias P hydr caused by the different heights of the pressure measurement locations of the access pressure sensor 25 and the return pressure sensor 26 should be considered.

[0221] In this variant, the lower limit pressure "Lvasc ret_Qb0 " and the upper limit pressure "Lvasc min " referring to the static return pressure "P max " can be different from the limit pressures referring to the static access pressure "P acc_Qb0 ".

[0222] Compare the static return pressure "P ret_Qb0 " with the return lower limit pressure and the return upper limit pressure, and compare the static access pressure "P acc_Qb0 " with the access lower limit pressure and the access upper limit pressure.

[0223] If Lretvasc min < P ret_Qb0 < Lretvasc max and / or Laccvasc min < P ret_Qb0 < Laccvasc max ), then the control unit 100 calculates the difference ((Pacc_Qb0 -P ret_Qb0 )–P hydr ) and compare this difference with the lower limit error “-E” and the upper limit error “+E” as shown above.

[0224] Algorithm 2

[0225] According to the second example algorithm, the control unit 100 calculates the access catheter pressure drop coefficient “K cath acc ” and the return catheter pressure drop coefficient “K cath ret ” through the following equations:

[0226] Equation 1) K cath ret = ((P ret -P ret_Qb0 ) / (μ x Qb)) – K line ret

[0227] Equation 2) K cath acc = ((P acc –P acc_Qb0 ) / (μ x Qb)) – K line acc

[0228] where

[0229] Qb is the stable and non-zero blood flow rate measured or set;

[0230] μ is the blood viscosity;

[0231] P ret 、P acc are the return pressure and access pressure measured when the blood flow rate is stable and non-zero;

[0232] P ret_Qb0 、P acc_Qb0 are the return pressure and access pressure measured when the blood flow rate is zero;

[0233] K line ret 、K line acc are the pressure drop coefficients of the blood return line 7 and the blood extraction line 6.

[0234] The blood viscosity and pressure drop coefficients of the blood return line 7 and the blood extraction line 6 can be obtained through experimental tests or calculated through the following equation:

[0235] Equation 3) μ = e (1,8 / T)x 5,54 x e 2,3x(Hct / 100)

[0236] μ Blood viscosity (mPa·s);

[0237] Hct Hematocrit of blood (percentage [0 - 100]);

[0238] T Blood temperature (°C).

[0239] Equation 4) K line ret =(128 x L ret ) / (π x d ret 4 )(mmHg / (ml / min) / (mPa s))

[0240] Equation 5) K line acc =(128 x L acc ) / (π x d acc 4 )(mmHg / (ml / min) / (mPa s))

[0241] L ret 、d ret Length and inner diameter of section 28 of blood return line 7;

[0242] L acc、 d acc Length and inner diameter of section 27 of blood extraction line 6.

[0243] Then, the control unit 100 compares the pressure drop coefficients "K cath ret ", "K cath acc " of the blood return line 7 and the blood extraction line 6 with the pressure drop coefficient reference value "K cath min ":

[0244] If K cath ret < K cath min And K cath acc < K cath min

[0245] Then the control unit 100 records that the extracorporeal blood circuit of device 1 is connected to the blood circuit of the high blood flow machine 36;

[0246] If K cath ret >= K cath min And K cathacc >= K cath min

[0247] Then the control unit 100 records that the extracorporeal blood circuit of device 1 is connected to the vascular access of patient "P".

[0248] If K cath ret >= K cath min And K cath acc < K cath min Or

[0249] If K cath ret < K cath min And K cath acc >= K cath min

[0250] Then the control unit records an indeterminate connection state.

[0251] "K cath min " can be obtained by analyzing the pressure drop of the catheter for each specific device or by analyzing the clinical records.

[0252] These decision steps recognize that in the case of a high blood flow machine, the blood access (i.e., both the access line and the return line) is directly connected to the high flow blood circuit, and the expected result of equations 1 and 2 is a zero pressure drop coefficient because there is no catheter at the end of the blood line.

[0253] Algorithm 3

[0254] Checking the correlation between the access pressure "P acc " and the return pressure "P ret " can be a third way to distinguish between the vascular access through the catheter and the connection to the high blood flow machine 36. This third way is performed during CRRT treatment and while the blood pump 10 is running and the blood flow "Q b " is non-zero.

[0255] According to the third way, during extracorporeal blood treatment, while the blood flow "Q b " remains constant, the access pressure "P acc " and the return pressure "P ret " are measured and monitored over time.

[0256] The following examples are only valid when Pacc < 0 and Pret > 0, which can match the access of the catheter or the access of the blood circuit of the high blood flow machine.

[0257] If at a certain point in time, the access pressure "P acc " decreases and the return pressure "P ret " increases, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine 36. This is a situation where the blood flow in the high blood flow machine 36 increases.

[0258] In addition, if at a certain point in time, the access pressure "P acc " increases and the return pressure "P ret " decreases, the control unit records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine 36. This is a symmetric scenario where the blood flow in the high blood flow machine 36 decreases.

[0259] Similar algorithms can be developed for other connection configurations.

[0260] Algorithms 1, 2, and 3 can also be implemented as two-step or three-step judgment methods. For example, algorithms 1 and 2 can be applied in sequence. If the main judgment step provides an uncertain connection state, for example, if the pressure conditions are within a range compatible with both the vascular access of the patient "P" and the connection to the blood circuit of the high blood flow machine 36, algorithm 3 can be used to confirm the initial main judgment performed using algorithm 1 and / or 2.

[0261] Once the connection type is identified, the control unit 100 can automatically set the device 1 according to the detected connection type, or can alert the operator, who sets the device 1 through the interface 110 according to the detected connection type. Table 1 below discloses by way of example the operating pressures accepted according to the detected connection (vascular access connection or ECMO connection).

[0262] Table 1

[0263] Pressure sensor Vascular access ECMO Return -20 mmHg to +350 mmHg -250 mmHg to +400 mmHg Access -250 mmHg to +20 mmHg -250 mmHg to +400 mmHg

[0264] As shown in Table 1, during the combined operation of the device for extracorporeal blood treatment and ECMO, the return pressure operating range is expanded to allow operation at a negative pressure before the high-flow centrifugal pump 38 in the ECMO circuit and to support operation at a higher positive pressure. The access pressure has been adjusted to allow operation at a positive pressure after the high-flow centrifugal pump 38 in the ECMO circuit.

[0265] Tables 2 and 3 below disclose by way of example the alarm pressures and limits set according to the detected connection (vascular access or ECMO). The pressure monitoring system of the device 1 is updated to allow operation at negative access pressure / return pressure.

[0266] Table 2 - Return Blocking Alarm

[0267]

[0268] Table 3 - Access Blocking Alarm

[0269]

[0270]

[0271] In the above table, the pressure increase / decrease item is related to a rapid change in the relevant pressure (e.g., a pressure change occurring in less than 5 seconds, optionally less than 2 seconds).

[0272] If there is a blood warming device "W" or a fluid warmer, the control unit 100 automatically enables the blood warming device "W" and / or the fluid warmer when the vascular access is connected, or disables the blood warming device "W" and / or the fluid warmer when the ECMO circuit is connected.

[0273] In fact, the device 1 for extracorporeal blood treatment should meet the requirements for limiting current leakage, and the connection of the device 1 to the ECMO may make the situation worse. Since the blood warming device "W" and the fluid warmer account for a large part of the current leakage, it is best to avoid using these warmers when combining the device 1 with the ECMO.

[0274] In addition, since the role of the ECMO in controlling the temperature of the patient "P" is much greater than the role of the device 1 for extracorporeal blood treatment in temperature control, the warming performed by the blood warming device "W" in the device 1 may be useless.

[0275] Although the present invention has been described in connection with the presently considered most practical and preferred embodiments, it should be understood that the present invention is not limited to the disclosed embodiments, but on the contrary, the present invention is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims.

Claims

1. An apparatus for extracorporeal blood treatment, comprising: a treatment unit (2); an extracorporeal blood circuit having a blood extraction line (6) connected to an inlet of the treatment unit (2) and a blood return line (7) connected to an outlet of the treatment unit (2), the extracorporeal blood circuit being configured to be connected to a vascular access of a patient (P) or to a blood circuit of a high blood flow machine (36); at least one pressure sensor (25, 26) configured to detect the pressure at at least one measurement location in the extracorporeal blood circuit; a blood pump (10) configured to control the blood flow (Qb) through the extracorporeal blood circuit; a control unit (100) connected to the blood pump (10) and the at least one pressure sensor (25, 26), the control unit (100) being configured to check the connection type of the extracorporeal blood circuit by performing the following procedure: - receiving at least one measured pressure from the at least one pressure sensor (25, 26); - detecting whether the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine (36) by performing an analysis on the at least one measured pressure or at least one parameter related to the at least one measured pressure; - emitting at least one signal if and when a connection to the blood circuit of the high blood flow machine (36) and / or a connection to the vascular access of the patient (P) is detected.

2. The apparatus according to claim 1, wherein, The at least one measured pressure includes an inlet pressure (P acc , P acc_Qb0 ) and / or an outlet pressure (P ret , P ret_Qb0 ); wherein the at least one pressure sensor (25, 26) comprises: An access pressure sensor (25), configured to measure the access pressure (P acc , P acc_Qb0 ) at a measurement location in the blood extraction line (6); and / or Return pressure sensor (26), configured to measure the return pressure (P ret , P ret_Qb0 ) at the measurement location in the blood return line (7).

3. The apparatus according to claim 1 or 2, wherein, Performing the analysis includes: comparing the at least one measured pressure or the at least one parameter related to the at least one measured pressure with at least one reference value.

4. The apparatus according to claim 3, wherein, The at least one measured pressure includes a static pressure (P ret_Qb0 , P acc_Qb0 ) measured by the at least one pressure sensor (25, 26) when the blood flow (Qb) through the extracorporeal blood circuit is zero, and wherein the at least one reference value includes a lower limit pressure (Lvasc min ) and an upper limit pressure (Lvasc max ); wherein the control unit (100) is configured to perform the following procedure: Receive the static pressure (P ret_Qb0 , P acc_Qb0 ); Receiving the lower limit pressure (Lvasc min ) and the upper limit pressure (Lvasc max ); Compare the static pressure (P ret_Qb0 , P acc_Qb0 ) with the lower limit pressure (Lvasc min ) and the upper limit pressure (Lvasc max ); wherein: If the static pressure (P ret_Qb0 , P acc_Qb0 ) exceeds the range between the lower pressure (Lvasc min ) and the upper pressure (Lvasc max ), the control unit (100) records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine (36).

5. The apparatus according to claim 3 when dependent on claim 2, wherein, The at least one measured pressure (P ret , P ret_Qb0 , P acc , P acc_Qb0 ) includes a static return pressure (P ret_Qb0 ) and a static access pressure (P acc_Qb0 ) measured by the access pressure sensor (25) and the return pressure sensor (26) when the blood flow (Qb) through the extracorporeal blood circuit is zero, wherein the at least one reference value includes at least one lower limit pressure (Lvasc min ) and at least one upper limit pressure (Lvasc max ); wherein the control unit (100) is configured to perform the following procedure: Receive the static return pressure (P ret_Qb0 ) and the static access pressure (P acc_Qb0 ); Receive the at least one lower pressure (Lvasc min ) and the at least one upper pressure (Lvasc max ); Compare the static return pressure (P ret_Qb0 ) and / or the static access pressure (P acc_Qb0 ) with the at least one lower pressure limit (Lvasc min ) and the at least one upper pressure limit (Lvasc max ); wherein: If the static return pressure (P ret_Qb0 ) and / or the static access pressure (P acc_Qb0 ) exceeds the range between the at least one lower pressure limit (Lvasc min ) and the at least one upper pressure limit (Lvasc max ), the control unit (100) records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine (36).

6. The apparatus according to claim 5, wherein, If the static return pressure (P ret_Qb0 ) and / or the static access pressure (P acc_Qb0 ) is / are within the range between the at least one lower limit pressure (Lvasc min ) and the at least one upper limit pressure (Lvasc max ), then the control unit (100) checks: when the height of the measurement position of the access pressure performed by the access pressure sensor (25) is the same as the height of the measurement position of the return pressure performed by the return pressure sensor (26), whether the difference between the static access pressure (P acc_Qb0 ) and the static return pressure (P ret_Qb0 ) is zero; or whether the difference between the static access pressure (P acc_Qb0 ) and the static return pressure (P ret_Qb0 ) is equal to the hydrostatic bias pressure (P hydr ), the hydrostatic bias pressure (P hydr ) being generated due to the different heights of the measurement position of the access pressure performed by the access pressure sensor (25) and the measurement position of the return pressure performed by the return pressure sensor (26); wherein: If the difference between the static access pressure (P acc_Qb0 ) and the static return pressure (P ret_Qb0 ) is non-zero, or if the difference between the static access pressure (P acc_Qb0 ) and the static return pressure (P ret_Qb0 ) is not equal to the hydrostatic bias pressure (P hydr ), then the control unit (100) records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine (36); or If the difference between the static access pressure (P acc_Qb0 ) and the static return pressure (P ret_Qb0 ) is zero, or if the difference between the static access pressure (P acc_Qb0 ) and the static return pressure (P ret_Qb0 ) is equal to the hydrostatic bias pressure (P hydr ), then the control unit (100) records that the extracorporeal blood circuit is connected to the vascular access of the patient (P).

7. The apparatus according to claim 3, wherein, The at least one parameter related to the at least one measured pressure includes at least one catheter pressure drop coefficient (K cath ), and wherein the at least one reference value includes a pressure drop coefficient reference value (K cath_min ); wherein the control unit (100) is configured to perform the following procedure: Receive the pressure drop coefficient reference value (K cath_min ); Calculate the at least one duct pressure drop coefficient (K cath ); wherein: If the at least one catheter pressure drop coefficient (K cath ) is less than the pressure drop coefficient reference value (K cath_min ), the control unit (100) records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine (36); If the at least one catheter pressure drop coefficient (K cath ) is greater than or equal to the pressure drop coefficient reference value (K cath_min ), then the control unit (100) records that the extracorporeal blood circuit is connected to the vascular access of the patient (P).

8. The apparatus according to claim 7, wherein, The at least one duct pressure drop coefficient (K cath ) includes an access duct pressure drop coefficient (K cath acc ) and / or a return duct pressure drop coefficient (K cath ret ); wherein: If the pressure drop coefficient (K cath acc ) of the access catheter and the pressure drop coefficient (K cath ret ) of the return catheter are less than the pressure drop coefficient reference value (K cath_min ), then the control unit (100) records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow machine (36); or If the pressure drop coefficient (K cath acc ) of the access catheter and the pressure drop coefficient (K cath ret ) of the return catheter are greater than or equal to the reference value of the pressure drop coefficient (K cath_min ), then the control unit (100) records that the extracorporeal blood circuit is connected to the vascular access of the patient (P).

9. The apparatus according to claim 8, wherein, If the pressure drop coefficient (K cath acc ) of the access catheter is greater than or equal to the reference value of the pressure drop coefficient (K cath_min ) and the pressure drop coefficient (K cath ret ) of the return catheter is less than the reference value of the pressure drop coefficient (K cath_min ), or vice versa, then the control unit (100) records an uncertain connection state.

10. The apparatus according to claim 2, wherein, Performing the analysis includes: checking the correlation between the access pressure (P acc ) and the return pressure (P ret ).

11. The apparatus according to claim 10, wherein, Checking for relevance includes monitoring over time the access pressure (P acc ) and the return pressure (P ret ) during at least a portion of the extracorporeal blood treatment; wherein, if while the blood flow rate (Qb) through the extracorporeal blood circuit remains constant, the access pressure (P acc ) decreases and the return pressure (P ret ) increases, or the access (P acc ) pressure increases and the return pressure (P ret ) decreases, then the control unit (100) records that the extracorporeal blood circuit is connected to the blood circuit of the high blood flow rate machine (36).

12. The apparatus according to any one of claims 1 to 11, wherein, the control unit (100) is configured to check the connection type at the start or restart of extracorporeal blood treatment and / or during the extracorporeal blood treatment.

13. The apparatus according to any one of claims 1 to 12, wherein, emitting at least one signal includes: transmitting a warning signal configured to alert the operator to the detected connection type; and / or Notify the operator of the operating parameters according to the detected connection type; and / or Set the operating parameters of the device according to the detected connection type.

14. The device according to claim 13, wherein, the operating parameters include: operating parameters according to a first value or a first range when a connection to the vascular access of the patient (P) is detected; operating parameters according to a second value or a second range when a connection to the blood circuit of the high blood flow machine (36) is detected; wherein at least one of the first value or the first range is different from at least one of the second value or the second range.

15. The device according to claim 14, wherein, a blood warming device (W) is coupled or configured to be coupled to the blood circuit of the device (1) for extracorporeal blood treatment, and / or a fluid warmer is coupled or configured to be coupled to one or more of the pump lines (16, 17, 18) and / or the dialysis line (11); wherein setting the device (1) according to the detected connection type includes: if a connection to the vascular access of the patient (P) is detected, enabling the blood warming device (W) and / or the fluid warmer; if a connection to the blood circuit of the high blood flow machine (36) is detected, disabling the blood warming device (11) and / or the fluid warmer.

16. The device according to any one of claims 1 to 15, wherein, the blood pump (10) is configured to generate an average blood flow rate of less than 250 ml / min, optionally less than 100 ml / min, optionally between 100 ml / min and 200 ml / min in the corresponding extracorporeal blood circuit during treatment.

17. The device according to any one of claims 1 to 16, wherein, the high blood flow machine is an extracorporeal membrane oxygenation ECMO machine or an extracorporeal life support ECLS machine or a cardiopulmonary machine for cardiopulmonary bypass.

18. The device according to any one of claims 1 to 17, wherein, the pump (38) of the high blood flow machine (36) is configured to generate a blood flow rate of greater than 1 L / min, optionally greater than 2 L / min, optionally between 2 L / min and 5 L / min in the corresponding blood circuit.

19. A combination of a device for extracorporeal blood treatment and a high blood flow machine, wherein, the device for extracorporeal blood treatment is according to any one of claims 1 to 18.

20. The combination according to the previous claim 19, wherein, the high blood flow machine (36) includes: a blood circuit including a venous line (37) and an oxygenation line (40), the blood circuit being provided with a cannula configured to be placed in a vein or artery of the patient (P); a pump (38); an oxygenator (39); Wherein, the blood extraction pipeline (6) and the blood return pipeline (7) of the device (1) for extracorporeal blood treatment are connected to / can be connected to the venous pipeline (37) and / or the oxygenation pipeline (40) of the high blood flow machine (36).

21. The combination according to claim 19 or 20, wherein, the pump (38) of the high blood flow machine (36) is configured to generate a blood flow rate greater than 1 L / min, optionally greater than 2 L / min, and optionally between 2 L / min and 5 L / min through the blood circuit and through the oxygenator (39).

22. The combination according to any one of the preceding claims 19 to 21, wherein, the high blood flow machine is an extracorporeal membrane oxygenation (ECMO) machine or an extracorporeal life support (ECLS) machine or a cardiopulmonary bypass machine for cardiopulmonary bypass.

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