Combination blood pump and oxygenator system

Abstract

A blood pump-oxygenator system (250A, 250B, 250C) for increasing perfusion and oxygen levels in the body of a patient (P), comprising: a blood inlet (80) and a blood outlet (90) connected to form a circuit operable as a cardiopulmonary bypass system suitable for extracorporeal treatment of the blood of the patient; a first blood pump (11) and a first oxygenator (20), wherein the first blood pump (11) is configured to deliver blood from the patient (P) through the circuit to the blood inflow port (80), through the first oxygenator (20), out of the blood outflow port (90) and back to the patient (P). The system further comprises a second blood pump (13) and a second oxygenator (21), wherein the second blood pump (13) is configured to deliver blood from the patient (P) through the circuit to the blood inflow port (80), through the second oxygenator (20), out of the blood outflow port (90) and back to the patient (P). The circuit comprises a first branch (101) and a second branch (102) arranged in parallel with each other, the first branch (101) accommodating the first blood pump (11) and the first oxygenator (20), and the second branch (102) accommodating the second blood pump (13) and the second oxygenator (21). The system further comprises a pump control unit (290) wherein the first and second blood pumps (11, 13) are configured to be controlled by the pump control unit (290) to increase or decrease the blood flow through the corresponding oxygenator (20, 21) by changing the proportion of the blood flow through the first and second oxygenator (20, 21).

Description

Technical Field

[0001] This invention generally relates to the field of blood pumps and oxygenators for increasing perfusion and oxygen levels in patients. More specifically, the invention provides a pump-oxygenator system that is easy to set up and use, compact in size, and improves patient mobility. Background Technology

[0002] Various types of blood pump-oxygenator systems are well known in the art. For example, in open-heart surgery, the patient is interconnected with an external pump-oxygenator system, often called a cardiopulmonary bypass machine, which circulates blood and introduces oxygen into the bloodstream. Most types of blood pumps employ roller pumps or centrifugal pumps to deliver blood within the patient's vascular system and / or via an extracorporeal system. Most types of oxygenators use a gas-permeable membrane, in which blood flows along one side of the membrane and oxygen is supplied to the other side. Assuming a sufficient pressure gradient exists between the oxygen supply and the blood, oxygen will diffuse through the membrane into the blood. Furthermore, carbon dioxide diffuses from the blood into the membrane. The membrane can be provided in the form of hollow fibers.

[0003] This system can be called extracorporeal membrane oxygenation (ECMO), also known as extracorporeal life support (ECLS). It is an extracorporeal technique that provides extended cardiac and respiratory support to people whose hearts and lungs cannot provide sufficient gas exchange or perfusion to sustain life. The technology used for ECMO is primarily derived from cardiopulmonary bypass (CLP), which provides short-term support when natural circulation has stopped. Typical CLP systems are quite complex and are generally not suitable for applications exceeding six hours. Furthermore, most standard systems exhibit poor hemodynamic characteristics. That is, such systems typically cause too much damage to the blood for long-term use.

[0004] For example, cardiopulmonary bypass systems are disclosed in US 3,890,969, US 4,466,804, and US 4,610,656. These conventional systems typically use multiple pumps, venous reservoirs, arterial reservoirs, and separate bubble traps. These conventional systems have several drawbacks. The most obvious drawback is the overall complexity of the system. For example, the numerous components require a large number of tubes and interconnections.

[0005] The complexity of traditional systems leads to higher manufacturing and operating costs. Furthermore, complex systems may require longer setup times and necessitate the presence of specialized personnel and supervision. Even with such personnel present, the complexity increases the risk of errors during setup. Similarly, once operational, traditional systems require continuous monitoring and adjustments by specialized personnel.

[0006] Traditional cardiopulmonary bypass systems are also unsuitable for long-term use because they significantly damage the blood after a relatively short period of use (e.g., 6-8 hours). For example, conventional occlusive roller pumps mechanically destroy red blood cells. This “blood trauma” can occur in any cardiopulmonary bypass system. Occlusive pumps, interconnects, and other system components that may increase system pressure or turbulence can cause and / or exacerbate this “blood trauma.” Similarly, using a conventional oxygenator for more than a few hours to a full day can lead to performance degradation due to plasma leakage into the hollow fibers.

[0007] The factors described above illustrate the need and expectation for a simpler cardiopulmonary bypass system with relatively few components. Devices similar to those disclosed in US 4,540,399 represent an attempt to achieve this simplification. That discloses an emergency bypass system with a non-occlusive pump, an oxygenator, and a separate bubble trap. A centrifugal rotor pump connected proximal to the oxygenator (i.e., the venous side) is described. While this may represent an attempt to provide a simplified cardiopulmonary bypass system compared to other known systems, further improvements are still considered necessary.

[0008] In other cases, a smaller implantable oxygenator may be sufficient to adequately supplement a patient's cardiopulmonary function by slightly increasing the oxygen content in their blood. For example, patients with emphysema, pneumonia, congestive heart failure, or other chronic lung diseases typically have a partial pressure of oxygen in their blood of about 40 torr. A relatively small increase of 10% to 20% is usually sufficient to adequately maintain the patient. This is a particularly desirable alternative because it avoids the need for intubation. Furthermore, in many cases, temporary use of this type of oxygenator may be sufficient to help patients overcome acute respiratory injury. Placing such patients on a conventional ventilator often leads to a gradual deterioration of their condition due to damage to the pulmonary tree, resulting in greater ventilator dependence.

[0009] Numerous devices and processes incorporating this fundamental technology have been invented in the past, including the following. US 3,505,686 illustrates a general concept of using gas-permeable fibers to enhance blood oxygen levels. In an implantable embodiment of this disclosure, the tubular housing serves as a shunt from the pulmonary artery to the left atrium of the heart, or more generally as a shunt between an artery and a vein. Multiple capillaries connected in parallel are used to oxygenate and / or purify blood circulating through the housing. US 4,583,969 illustrates a transvenous oxygenator made of multiple small-diameter gas-permeable tubes. However, in the specific device of this disclosure, two incisions may be required. The insertion process is also quite complex. US 4,631,053 discloses a transvenous oxygenator having a single membrane through which oxygen diffuses. The membrane is disposed within a sheath, and both are supported by flexible wires.

[0010] WO 2021 / 170712 A1 discloses a combined blood pump and oxygenator system and related methods. A blood pump-oxygenator system is provided, comprising at least one blood pump, an oxygenator, an inlet cannula, and an outlet cannula, connected together to form a closed series loop, thereby operating as a cardiopulmonary bypass system suitable for extracorporeal processing of patient blood. The blood pump is configured to deliver blood from the patient through the loop into the inlet cannula, through the oxygenator, and then back into the patient from the outlet cannula. A manifold is connected between the inlet and outlet cannulas, allowing blood to pass through the manifold, which houses the blood pump and oxygenator, and is designed to form a recirculation loop configured to recirculate at least a portion of the blood in the loop, thereby allowing the blood to pass through the oxygenator multiple times. The system also includes an additional blood pump located at the outlet cannula and configured to deliver a predetermined volume to the patient, wherein the additional pump is configured to be controlled independently of the blood pump that circulates blood in the manifold including the oxygenator.

[0011] In recent years, many centers have been using commercially available pumps and oxygenators to implement non-ambulatory ECMO support, allowing patients to walk, eat, and exercise. This is an improvement because it allows patients to move and participate in physical rehabilitation, prevents muscle atrophy, and ultimately leads to a better clinical course for recovery or a better condition at the time of heart-lung transplantation.

[0012] Currently available oxygenators are often very large and require frequent replacements for long-term support, which is typically not feasible without disrupting the entire system. Furthermore, the rigid nature of current commercially available oxygenators usually limits the blood circulation path, restricting the circulation of blood distributed throughout the entire area of ​​the oxygenator. This leads to rapid wear of the same hollow fibers (in which blood always circulates) and shortens the lifespan of the entire system.

[0013] Furthermore, known ECMO typically comprises a single oxygenator, through which, for example, 100% pure oxygen or a gas mixture of, for example, 80% oxygen and 20% air, is supplied at any time via hollow fibers to both increase the oxygen level in the blood and remove carbon dioxide from the blood and from the oxygenator. However, this requires a high flow rate of the gas mixture, for example, up to 15 L / min. This, in turn, requires large quantities of pure oxygen, which is typically delivered from bulky oxygen cylinders, limiting the patient's mobility.

[0014] There is a need for a circulatory support system capable of supporting patients with circulatory dysfunction for a certain period of time. Such a circulatory support system would be very useful in many situations, such as (1) when the patient is in cardiogenic shock; (2) when the patient is in septic shock; (3) for weaning from cardiopulmonary bypass after cardiac surgery; (4) for assisting the circulatory system to prevent impending myocardial infarction; and (5) for bridging therapy before transplantation. It may also be necessary to provide a circulatory support system that can be used in an active environment and allows the patient to move freely. Summary of the Invention

[0015] One object of the present invention is to provide an improved blood pump and oxygenator system. Specifically, the present invention aims to address at least one of the aforementioned needs and eliminate or at least reduce at least one disadvantage of the aforementioned prior art systems.

[0016] The technical solutions in the independent claims provide a solution to this problem. The technical solutions in the dependent claims provide various preferred embodiments of the invention.

[0017] According to one aspect, a blood pump-oxygenator system for increasing perfusion and oxygen levels in a patient includes: a blood inlet and a blood outlet connected to form a loop capable of operating as a cardiopulmonary bypass system suitable for extracorporeal processing of a patient's blood; a first blood pump and a first oxygenator, wherein the first blood pump is configured to deliver blood through the loop from the patient to the blood inlet, through the first oxygenator, and out of the blood outlet back into the patient. The system also includes a second blood pump and a second oxygenator, wherein the second blood pump is configured to deliver blood through the loop from the patient to the blood inlet, through the second oxygenator, and out of the blood outlet back into the patient. The loop includes a first branch and a second branch arranged in parallel with each other, the first branch housing the first blood pump and the first oxygenator, and the second branch housing the second blood pump and the second oxygenator. The system also includes a pump control unit, wherein the first and second blood pumps are configured to be controlled by the pump control unit to increase or decrease the blood flow through the corresponding oxygenator by changing the ratio of the blood flow through the first oxygenator to the blood flow through the second oxygenator.

[0018] In the system of this invention, two blood pumps and two oxygenators are provided, arranged in parallel branches, meaning the pumps and oxygenators can operate in parallel. More specifically, the proportion of blood flow through the oxygenators can be varied, allowing for efficient use of both oxygenators. In this way, since the residence time of blood in the oxygenators can be controlled, the oxygenation of blood delivered through the system (particularly through the oxygenators) can be improved. This, in turn, allows for a compact system design, thereby increasing the patient's activity level. More specifically, the residence time (i.e., the duration of blood in the oxygenators) can be increased, as will be described in more detail below. For example, the residence time can be controlled by slowing the blood flow through one oxygenator and speeding up the blood flow through the other oxygenator.

[0019] The system of this invention can provide local venous-arterial cardiopulmonary support for a relatively long period (i.e., 1 to 10 days) due to its very low overall hemoinvasiveness and improved ease of use. This system not only provides cardiopulmonary support but also hemodynamic support over potentially long periods. The system of this invention is particularly suitable for local hemodynamic support. Nevertheless, it is readily understood that this system is also suitable for achieving many additional goals in various situations involving circulatory dysfunction. The system of this invention can assist circulation during relatively mild circulatory dysfunction and can also provide acute support during severe refractory heart failure caused by myocardial infarction, cardiomyopathy, or post-cardiac surgery. The system of this invention can also be used to provide perioperative support and stabilization for high-risk patients, such as those undergoing coronary artery bypass grafting.

[0020] The system of this invention can also cause less damage to the blood compared to conventional systems by reducing the surface area interacting with the blood, making the system of this invention more suitable for long-term use. Trauma to the patient's blood can be reduced primarily by simplifying the blood circuit, especially by reducing the number of circuit components, using a non-blocking pump, and one or more oxygenators. Furthermore, overall trauma to the patient can be reduced. This can be achieved by reducing the amount of blood handled outside the body compared to conventional bypass systems and procedures. Eliminating a separate fluid reservoir reduces the fluid volume of the system. Because less blood is drawn from the patient at a time, overall trauma to the patient can be reduced.

[0021] The system's low-invasiveness contributes to its overall hemodynamic characteristics. Many of the features of this invention that improve the overall hemodynamics of the system also contribute to its simplification, making it more reliable and compact. To further reduce the risk of system failure, the system can be equipped with various fail-safe functions. This equipment can be used to monitor and control various pressures and flow rates to ensure proper operation. Although the system of this invention may require periodic monitoring and adjustments by professionals during operation, it can operate relatively automatically, as will be described in more detail below. That is, compared to more complex conventional systems, the system of this invention requires less monitoring and adjustments during operation.

[0022] As used herein, the term "oxygenator" specifically refers to a medical device configured to oxygenate blood and remove carbon dioxide from it. It is used to maintain gas exchange, for example, as part of a cardiopulmonary bypass machine in cardiac surgery, or in intensive care to treat acute respiratory failure. The oxygenator temporarily replaces the function of the lungs. Specifically, an oxygenator may be a membrane oxygenator. Such an oxygenator may have hollow fibers, such as hair-like fibers. The fibers may be arranged in a "group" or "bundle," where each group of fibers may have a common inlet and outlet. An oxygenator may include multiple hollow oxygenating fibers that allow blood to pass between the oxygenating fibers to inhale oxygen and release carbon dioxide, while oxygen and / or air pass from an inlet cavity at one end of the oxygenating fiber through the inner lumen of the fiber and return from the other end to an outlet cavity. Oxygen and air may be delivered to the oxygenator via an inlet tube connected to the inlet, and an outlet tube connected to the outlet may be provided for removing carbon dioxide from the oxygenator.

[0023] As used herein, the term "blood pump" (or simply "pump") specifically refers to a medical device used to pump blood, particularly blood via an extracorporeal system. A blood pump can be a rotary pump or a displacement pump, such as a centrifugal or axial-flow rotary pump, wherein the blood pump can be configured to be directly driven by an electric motor or by a flexible drive cable that magnetically or directly connects the blood pump to the electric motor. The rotor can be located within the pump housing, wherein the drive cable can be located within a sheath connected to the rotor in such a way that rotation of the drive cable, driven by the electric motor, causes rotation of the rotor and pumps blood from the distal end of the housing to the proximal end, thereby delivering blood from the blood inlet to the blood outlet.

[0024] Where applicable, the terms “first,” “second,” “third,” etc., in the specification and claims are used to distinguish between similar elements and are not necessarily used to describe order or chronological sequence. It should be understood that such terms are interchangeable where appropriate, and embodiments of the invention described herein can operate in a different order than those described or shown herein.

[0025] The use of the terms "comprising" or "including" in this specification and claims does not exclude other elements or steps. When referring to a singular noun, the indefinite or definite article, such as "a," "an," or "the," is used, and unless otherwise expressly stated, the plural form of the noun is included.

[0026] Furthermore, unless otherwise explicitly stated, "or" refers to "inclusive or," not "exclusive or." For example, the condition "A or B" satisfies any of the following conditions: A is true (or exists) while B is false (or does not exist); A is false (or does not exist) while B is true (or exists); or both A and B are true (or exist).

[0027] Other preferred embodiments of the system are described below, which can be combined arbitrarily with each other or with other aspects of the invention, unless such combination is explicitly excluded or technically impossible to implement.

[0028] In some embodiments, the first and second blood pumps are configured to be controlled by a pump control unit to increase or decrease the blood flow through the corresponding oxygenator in a synchronous and opposite manner. In some embodiments, the first and second blood pumps are configured to be controlled by a pump control unit to increase or decrease the blood flow through the corresponding oxygenator while maintaining the total flow at a desired level. In this way, the total amount of blood delivered through the system does not necessarily change, but the residence time in each oxygenator can be increased. More specifically, when blood flow increases in one oxygenator, blood flow decreases in the other, and vice versa. This allows for enhanced oxygenation in one oxygenator for a longer period while one oxygenator is being emptied, thereby ensuring that blood flow to the patient is not affected.

[0029] In some embodiments, the system further includes a gas control unit configured to control the oxygen and air flows to the first and second oxygenators in a manner that alters the ratio of the flow rates of oxygen and air flowing through the first oxygenator and the flow rates of oxygen and air flowing through the second oxygenator, respectively. For example, the gas control unit may control a four-way mixing valve. Controlling the gas flow rate helps to significantly reduce the amount of (pure) oxygen (O2 gas) required, particularly compared to a conventional system with only one oxygenator. In such a conventional system, it may be necessary to maintain a high flow rate of the oxygen-air mixture (e.g., 80% oxygen and 20% air), such as 15 L / min, to ensure that the blood receives sufficient oxygen on the one hand, and that carbon dioxide (CO2) is adequately removed on the other, and that carbon dioxide is purged from the oxygenator. The gas control unit allows switching between oxygen and air, thereby reducing the total amount of oxygen required. For example, sometimes a high proportion of air may be supplied to wash out the oxygenator, while at other times a high proportion of oxygen may be supplied to achieve adequate oxygenation of the blood. This also allows for the preferred method of repeatedly washing out the oxygenator using only air. Furthermore, since there is no need for specialized fibers used only for oxygen or only for air in the oxygenator, the entire bundle of fibers can be used efficiently, thereby reducing uneven degradation of the oxygenator. The gas control unit can be configured to synchronize with the pump control unit. For example, the maximum amount of oxygen can be supplied to one oxygenator where blood flow is slowed, while the maximum amount of air is supplied to another oxygenator to purge blood and flush that other oxygenator.

[0030] In some embodiments, the system further includes an oxygen concentrator for supplying oxygen to the first and second oxygenators and an air compressor for supplying air to the first and second oxygenators. This eliminates the need for bulky oxygen cylinders. Air can be easily obtained from ambient air using a simple pump.

[0031] In some embodiments, the system further includes a valve located in each branch between the corresponding blood pump and the corresponding oxygenator to prevent blood from flowing backward from the oxygenator to the blood pump. Particularly in oxygenators where blood flow is slowed, pressure in parallel branches with faster blood flow can push blood backward. This can be prevented by providing a corresponding valve. Such a valve can be a simple check valve (one-way valve).

[0032] In some embodiments, the circuit includes a branch point and a confluence point, the branch point diverting blood flow in the circuit into two branches, at least two branches converging at the confluence point, wherein at least one of the branch point and the confluence point is configured as a multi-way control valve operable to select at least one of the two branches for blood flow. Setting a multi-way control valve (e.g., a three-way or four-way valve) allows control over the proportion of blood flowing through each branch (and thus through each oxygenator). Specifically, the valve can be controlled such that blood flows through only one branch at a time. If multi-way valves are provided at each branch point and confluence point (i.e., at the beginning and end of parallel branches), these valves can be synchronized to establish a flow path that passes through only a single branch at a time. The valves can also be synchronized with a pump. Thus, while one oxygenator is being emptied, the residence time of blood in another oxygenator can be increased. Furthermore, the oxygenator can be easily replaced by blocking the corresponding branch, while the other branch (and therefore the other oxygenator) can continue to operate. The feasibility of replacing the oxygenator without stopping the system increases the system's practicality for long-term use. Over time, the function of an oxygenator typically tends to deteriorate rapidly. Therefore, the feasibility of replacing the oxygenator without interrupting patient support can increase the overall lifespan of the system.

[0033] Multi-port control valves can have multiple ports (openings), one of which can be used as an inlet or outlet, while the remaining ports serve as both inlet and outlet. For example, a three-way control valve has three ports through which volume flow enters or exits. They can be used as mixing valves or flow dividers (also called switching valves). Flow can be regulated by electric actuators, pneumatic actuators, or electro-pneumatic actuators. A three-way mixing valve has two inlets and one outlet, where two streams (especially those from branches at the junction) flow into the valve and then exit via the third port. In a flow divider (one inlet and two outlets), the incoming volume flow is distributed to the two outlets, connecting to the branch at the junction.

[0034] In some embodiments, a reservoir is provided at the confluence point, wherein the reservoir includes at least two inlet ports, an outlet port, and at least one vent. Each branch terminates in the reservoir at its corresponding inlet port, such that all blood from the branch (and thus from the oxygenator) is supplied to and mixed in the reservoir. The collected blood exits the reservoir at the outlet port, which extends toward the interior of the reservoir. The at least one vent is configured to expel air bubbles from the blood in the reservoir. Therefore, the reservoir may also be referred to as a bubble removal device or a "bubble trap". It is advantageous to remove air bubbles at this point in the system via the reservoir because further circulation of air bubbles can be avoided, although air bubbles can also be removed by a bubble trap at the blood outlet, as described below.

[0035] Specifically, the basic principle for removing air bubbles can be that during operation, the reservoir is positioned with one or more vents above it, because air bubbles will rise. One or more inlet ports are also located at the top, while the outlet ports are designed to draw blood from a position below the vents, for example, through a tube or the like extending into the reservoir (e.g., towards the center of the device or further downwards). Exemplary embodiments will now be described in more detail with reference to the accompanying drawings.

[0036] In some embodiments, the system further includes a first oxygen sensor, a second oxygen sensor, and a third oxygen sensor, all configured to measure the oxygen level in the blood. The first oxygen sensor is located upstream of the first and second oxygenators, particularly upstream of a branch point (or at or near the blood inlet). The second oxygen sensor is located in the first branch and downstream of the first oxygenator to obtain the oxygenation rate of the first oxygenator by comparing the oxygen level measured by the first oxygen sensor with the oxygen level measured by the second oxygen sensor. The third oxygen sensor is located in the second branch and downstream of the second oxygenator to obtain the oxygenation rate of the second oxygenator by comparing the oxygen level measured by the first oxygen sensor with the oxygen level measured by the third oxygen sensor. This allows for monitoring the function of the oxygenators. It should be understood that it is preferable to place one oxygen sensor downstream of each oxygenator in each branch so that the oxygenation level of the blood can be monitored after the blood flows through the corresponding oxygenator, which can be used to monitor oxygenator deterioration. However, a single oxygen sensor upstream of the oxygenator (downstream of the confluence point, or at or near the blood outlet) may be sufficient. In this situation, only the total oxygenation level of the two oxygenators can be monitored.

[0037] In some embodiments, the first and second blood pumps can be configured to be controlled to set their pump rate based on the respective obtained oxygenation rates. For example, the pump rate can be increased when the oxygenation rate decreases. The obtained oxygenation rate can be used to control the system. Specifically, if a decrease or continued decrease in oxygenation provided by the oxygenator is detected, the pump rate can be increased to increase the amount of blood passing through the oxygenator and maintain the oxygen level.

[0038] In some embodiments, the system further includes at least one of a first pressure sensor and a second pressure sensor, wherein the first pressure sensor is located at or near the blood inlet and configured to measure the input pressure of the circuit, and the second pressure sensor is located at or near the blood outlet and configured to measure the output pressure of the circuit, wherein the first and second blood pumps are configured to be controlled by the pump control unit to set the pumping rate of the first and second blood pumps according to the measured input pressure, wherein preferably, the pumping rate increases when the input pressure drops to a predetermined threshold. A pressure sensor at the blood inlet is particularly useful for monitoring the input pressure of the system. In particular, negative pressure in the system (especially in the pumps) should be avoided, as this can cause air bubbles to form in the blood. It is also important to monitor the pressure of the blood returned to the patient to avoid harm to the patient, for example, due to excessively high output pressure.

[0039] In some embodiments, the system further includes a third pressure sensor and a fourth pressure sensor, wherein the third pressure sensor is located in the first branch and upstream of the first oxygenator, and the fourth pressure sensor is located in the second branch and upstream of the second oxygenator, thereby detecting pressure differences (specifically, pressure drops caused by the first and second oxygenators, respectively) by comparing the pressure measured by the first pressure sensor with the pressures measured by the third and fourth pressure sensors, respectively. Monitoring the pressure before and after the oxygenator allows for monitoring the oxygenator's functionality. Specifically, if the oxygenator is clogged, a pressure drop (i.e., in other words, an increased pressure differential) may occur. This fault can be easily and quickly detected, and the corresponding oxygenator can be replaced.

[0040] In some embodiments, the system further includes at least one flow meter for measuring blood flow, comprising at least one of a first flow meter and a second flow meter. The first flow meter is disposed at or near the blood inlet and configured to measure blood flow from the patient, and the second flow meter is disposed at or near the blood outlet and configured to measure blood flow returning to the patient. Specifically, the inflow and outflow flows can be compared to draw conclusions about any possible losses in the system. Additional flow meters may be placed after a corresponding oxygenator in the first and second branches to monitor blood flow leaving the oxygenator, particularly compared to the inflow blood flow measured by the first flow meter. It should be understood that various flow meters can be placed throughout the system, for example, at locations where pressure sensors are disposed. The measurement data from the pressure sensors and the flow meter measurements together provide detailed information about the system status and function.

[0041] This system can be considered as having a pressure feedback system, particularly for controlling the pump suction force of one or more blood pumps. The pump-oxygenator system of the present invention can be equipped with a pressure feedback system to control the pump suction force, and also eliminates the need for a separate reservoir. In this respect, compared to conventional systems (which typically include one or more separate reservoirs, etc.), this system can be a relatively static-volume system. The pump-oxygenator system can be equipped with an electric heater and insulation, thus eliminating the need for a heat exchanger to maintain fluid temperature. The reduction in system size and the shortening of the blood's residence time outside the patient also eliminate the need for a heat exchange system. It should be understood that, however, a heat exchange system may still be provided.

[0042] In some embodiments, the system further includes a bubble trap at or near the blood outlet, wherein the bubble trap is configured to receive any blood before the blood is returned to the patient through the blood outlet and to retain any bubbles before the blood leaves the bubble trap.

[0043] In some embodiments, a first blood pump and a first oxygenator are configured as a first integrated unit, and a second blood pump and a second oxygenator are configured as a second integrated unit. The integrated unit may also include the aforementioned valves and / or flow meters. Providing an integrated unit allows for easy handling, such as installation, removal, or replacement of the oxygenator and its associated pumps, and possibly valves and flow meters. The integrated unit may also be referred to as a “set,” “module,” or “cartridges.”

[0044] According to another aspect, a support device is provided, configured to support the aforementioned blood pump-oxygenator system (more specifically, at least a portion thereof). As described above, the system can have a compact design to improve patient mobility. Providing a support device further enhances patient mobility. The support device can be, for example, a trolley, lift, or other stand that can have wheels to allow the patient to move around. The support device can be part of a wheelchair, attached to a wheelchair, or configured to be attached to a wheelchair (e.g., an electric wheelchair), wherein the system can be positioned, for example, behind the patient. The support device may also include an integrated locking mechanism configured to connect to the blood inlet, blood outlet, oxygen inlet, oxygen outlet, and power port of the blood pump-oxygenator system. This allows the system to be easily placed on the support device (e.g., when moving it from the bedside to the support device). The system can simply snap into the locking mechanism, thereby instantly establishing all necessary connections without the need for separate connections of various plugs.

[0045] According to another aspect, a wheelchair (particularly an electric wheelchair) is provided, which includes one or more of the following components to improve the patient's mobility. Specifically, it is conceivable to provide one or more (preferably all, at least all basic) medical machines for intensive care units (ICUs), which are typically provided in stationary ICUs. This allows even critically ill patients to be mobile. It should be understood that the wheelchair can be configured to use or not use any of the aforementioned blood pump-oxygenator systems.

[0046] An oxygen supply unit can be set up, for example, to supply oxygen to the patient or any medical machine at a rate of 10 L / min. The oxygen supply unit may include one or more oxygen cylinders or an oxygen generator to produce oxygen as needed, for example, to be supplied to an ECMO or simply supplied to the patient's nose via a tubing. A power source, such as one or more (rechargeable) batteries, can be set up to power any medical machine as needed. Specifically, the power source capacity can be configured to provide continuous power during system movement. When a wall power outlet is available, the system can be reconnected to that outlet to charge the batteries or to power the system directly. One or more interfaces (e.g., plugs) can be provided for all types of components, particularly oxygen and power, as needed. Additional components can be added as needed, such as heating / cooling units (e.g., for heating blood to 37°C), remote controls for controlling wheelchairs or other equipment (e.g., carrying devices), or entertainment units (e.g., monitors or tablets for watching TV, movies, games, etc.). Furthermore, a GPS device can be provided to track the wheelchair, for example, when the patient is moving around in the wheelchair without the assistance of a nurse, caregiver, or other person.

[0047] In some embodiments, the wheelchair includes a support device (for supporting one or more of the aforementioned components, or even other components). The support device can be of the type described above. However, particularly for cases where a blood pump-oxygenator system is not used, another type of support device can be provided. This support device may have a base mounted to a lift section, such that the base is configured to move up and down to lift components above it from the ground. The lift section may be attached to the back of the wheelchair. This facilitates the mounting and removal of heavier components (such as oxygen cylinders / oxygen concentrators or batteries) from the wheelchair, especially in these cases.

[0048] In some embodiments, the wheelchair is configured to have various configurations (positions). Specifically, the wheelchair can be configured to be tilted or reclined, i.e., particularly the backrest and / or leg / footrest can be configured such that their angles can be changed. Preferably, the wheelchair can be adjusted to a substantially or even fully flat position (at a 180-degree angle to the seating area) to achieve a bed-like configuration. This is particularly advantageous for intensive care patients or other patients with severe mobility impairments, as it avoids the effort (or even inability) they would have to transfer from the wheelchair to a separate bed. The wheelchair may have additional wheels at the upper end of the backrest to provide better support and mobility even in the bed-like configuration. These wheels can be configured to fold up when the backrest is in an upright position. Side sections can be provided, which in the bed-like configuration can be configured to fold laterally to increase the reclining area. Such sides may include armrest-like sides, sides on the leg / footrest, and / or sides on the backrest. When folded upwards, these sides can provide support and safety for the patient (in all configurations of the wheelchair). For hygiene and / or comfort, any type of covering, sheet, or mat (such as replaceable (reusable (washable) or disposable) sheets) can be used to cover the area in the bed configuration.

[0049] In any of the above systems, the pump operates cyclically in a time-dependent manner in relation to the patient's heart rate or a physiological parameter, and the pump control unit can adjust the pump's speed in response to changes in said physiological parameter. The device itself, controller, drive lines, and power supply can be mounted on a support structure, allowing the patient to move around. This significantly improves the patient's mobility compared to bulky immobilization devices.

[0050] Regarding access to the patient's bloodstream, any of the aforementioned systems can be used in standard ECMO procedures, meaning no specialized instruments, access channels, guides, etc., are required. For example, a suitable cannula can be percutaneously placed into the desired blood vessel (e.g., vein and / or artery) via the Seldinger technique or through a surgical incision.

[0051] It should be understood that the explanations, embodiments, and advantages described above in conjunction with one aspect can also be applied to any other aspect of the invention. Attached Figure Description

[0052] The following describes illustrative embodiments with reference to the accompanying drawings. For clarity, not all features of the actual implementation are described in this specification. It should be understood, of course, that in the development of any such actual embodiment, many implementation-specific decisions can be made to achieve the developer's specific goals (e.g., compliance with system-related and business-related constraints), which will vary depending on the implementation. In the accompanying drawings: Figure 1 An embodiment of a pump-oxygenator system with two oxygenators and two pumps is shown, wherein each pump is associated with one of the oxygenators; Figure 2 An embodiment of a pump-oxygenator system with two oxygenators, two pumps, and a reservoir is shown, wherein each pump is associated with one of the oxygenators; Figure 3 An embodiment of a pump-oxygenator system with two oxygenators, two pumps, and a reservoir is shown, wherein each pump is associated with one of the oxygenators, and the oxygenators and pumps are arranged in combination. Figure 4 It shows Figure 3 A diagram showing the motor power of the blood pump in an embodiment; Figure 5 It shows Figure 3 Connection of the pump-oxygenator assembly in the embodiment; Figure 6 A trolley for carrying a blood pump-oxygenator system is shown; Figure 7 A blood pump-oxygenator system connected to the console is shown; Figure 8 An embodiment of a wheelchair being towed with a trolley equipped with a pump-oxygenator system is shown; Figure 9 Another embodiment of the wheelchair in the first configuration is shown; Figure 10 The second configuration is shown. Figure 9 wheelchair; Figure 11 The third configuration is shown. Figure 9 wheelchair; Figure 12 The third configuration is shown with additional covering. Figure 9 wheelchair; Figure 13 The first configuration of the device is shown. Figure 9 wheelchair; Figure 14 It shows Figure 13 The support device for the wheelchair; Figure 15 An embodiment of a spherical liquid reservoir with multiple vents is shown; and Figure 16 An embodiment of a liquid reservoir that is mushroom-shaped and has multiple vents is shown. Detailed Implementation

[0053] Figures 1 to 3 Embodiments of (extracorporeal) blood pump-oxygenator systems 250A, 250B, and 250C (hereinafter referred to as "the System") are shown, which provide a loop between a blood inlet 80 and a blood outlet 90, having two parallel branches 101 and 102, each branch having an oxygenator 20 and 21 and a blood pump 11 and 13. In other words, each of the systems 250A, 250B, and 250C includes two oxygenators 20 and 21 and two blood pumps 11 and 13.

[0054] One aspect of the pump-oxygenator systems 250A, 250B, 250C, which have two oxygenators 20, 21 (and two pumps 11, 13), is the ability to replace worn oxygenators without stopping the system. This eliminates a major drawback of many known systems: even replacing a single component requires stopping the entire system. This, in turn, requires reloading the system after the replacement procedure is completed. To enable the replacement of oxygenators 20, 21, a switch can be provided that allows selection of one or more branches 101, 102, thereby selecting the corresponding oxygenator 20, 21, while simultaneously deactivating the oxygenator to be replaced. This “switch-off” capability of the systems disclosed herein is a significant improvement because component replacement may frequently be required due to the rapid degradation of oxygenator components.

[0055] In addition, systems with more than one oxygenator have redundancy to prevent system failure in the event of one oxygenator's failure. Furthermore, oxygenators 20 and 21 can be designed to be smaller in size compared to systems with only one oxygenator. The residence time of blood in oxygenators 20 and 21 can be increased. This is further supported by providing two pumps 11 and 13, each configured to supply blood to one oxygenator 20 or 21. Systems 250A, 250B, and 250C improve patient safety by providing greater redundancy and increased safety when replacing pumps. Each branch 101 and 102 provides full functionality and can continue operating while components in another branch are being replaced.

[0056] Two branches 101 and 102, each with oxygenators 20 and 21 and blood pumps 11 and 13, are connected to a blood inlet 80 and a blood outlet 90. Therefore, blood flows through each oxygenator 20 and 21 as blood is delivered from and to patient P via systems 250A, 250B, and 250C. The residence time of blood within each oxygenator 20 and 21 can be increased by controlling the flow through branches 101 and 102 in a coordinated manner. More specifically, this control can be achieved by means of the above-mentioned… Figure 4 The pump control unit is used to achieve this, wherein pumps 11 and 13 are controlled in a counteracting manner.

[0057] Blood is drawn from patient P, enters systems 250A, 250B, and 250C at blood inlet 80, and is then returned to patient P at blood outlet 90. Blood inlet 80 and blood outlet 90 can be provided via inflow cannula 80 and outflow cannula 90, respectively. Cannulas 80 and 90 can be cannulas of any suitable known structure for blood delivery. Cannulas 80 and 90 can be made of any suitable biocompatible material, including but not limited to polyurethane or silicone or similar biocompatible materials. Cannulas 80 and 90 can be reinforced with wire or similar materials to help prevent kinking when the cannulas are bent at a sharp radius. All these details are well known in the cannula manufacturing industry and are included herein for clarity.

[0058] Blood pumps 11 and 13 can be configured (by way of example only) as rotary or reciprocating pumps, more specifically centrifugal rotary pumps. Centrifugal pumps are a known technology in the field of blood pumping and are preferred due to their low manufacturing cost and minimal trauma to the blood. Blood pumps 11 and 13 can be directly driven by an electric motor or by a flexible cable connecting the pump to the electric motor (e.g., as described in US 4,944,722). The connection between the pump and the drive mechanism can be magnetic or direct. Pumps 11 and 13 are shown as centrifugal types with a rotor located within a pump housing. The pump can be driven by a drive cable within a sheath connected to the rotor (not shown). Rotation of the drive cable driven by the electric motor (not shown) causes rotation of the rotor and pumping of fluid (blood) through the pump housing. In this way, fluid is delivered from the inlet sleeve 80 toward the outlet sleeve 90. Specifically, the pump can generate suction that draws blood from the patient P into the system 1 through the inlet sleeve 80 and delivers blood from the inlet sleeve 80 to the outlet sleeve 90.

[0059] Essentially, this system is designed to drain venous blood and infuse oxygenated blood during diastole, and to deliver blood through an oxygenator during systole. This allows the heart to pump at lower system pressures, which translates to lower myocardial load.

[0060] Systems 250A, 250B, and 250C may also include a bubble trap 70 at the blood outflow outlet. All blood is purged into the bubble trap 70 before leaving the outflow sleeve 90. The bubble trap 70 is used to remove any air bubbles from the pumped blood. The bubble trap 70 may include an vent (not shown) to expel any air trapped in the bubble trap 70. Measures may be provided to increase the residence time of the pumped blood in the bubble trap 70 to separate smaller air bubbles from the pumped blood. The bubble trap 70 may also include a filter (not shown) to capture any impurities from the pumped blood before it is returned to the patient P.

[0061] The method of using the pump-oxygenator system described in this article for the treatment of heart failure (by way of example only) is described below: To install this system, the inflow cannula 80 is percutaneously inserted into the patient's vein. The inflow cannula 80 is available in many different diameters and lengths to suit different patients and applications. The Seldinger technique can be used to insert the cannula 80 into the femoral vein to drain venous blood into the circuit.

[0062] The inlet cannula 80 can then be connected to the selected circuit. Due to the small volume of the entire circuit, blood can be used to fill it. Because standard cardiopulmonary circuits have a large volume, they are usually filled with saline. The standard circuit volume can range from 100 cc (cubic centimeters). 3 Up to 1500 cc. The loop volume of the system can be much lower than 100 cc, and possibly as low as 10 cc. This difference in filling volume is a key factor allowing the use of blood instead of saline to fill the loop. Using a patient's blood filling system eliminates the dilution of the patient's blood that occurs when using saline. Diluting the patient's blood with saline may reduce the blood's oxygen-carrying capacity, thus requiring a higher level of circulation to achieve the same level of tissue oxygenation.

[0063] The outflow cannula 90 can be inserted into the patient in a similar manner to the insertion of the inflow cannula 80 (i.e., using the Seldinger technique). The outflow cannula 90 can preferably be filled with the patient's blood. When the outflow cannula 90 is placed in an artery, a pair of hemostats can be used to control the blood flow through the outflow cannula 90.

[0064] The filled circuit can then be attached to the filled outflow sleeve 90 while keeping the outflow sleeve 90 clamped to control the flow into or out of the outflow sleeve 90. All sleeves (inflow sleeve 80 and / or outflow sleeve 90) can be equipped with quick-connect fittings for quick and easy attachment of the sleeves to the circuit. Large amounts of air can then be removed through any port (e.g., the port of the bubble trap 70).

[0065] The circuit has a branch point 105 at which it branches into parallel branches 101 and 102. Branch point 105 can be configured as a simple T-type or Y-type connector. Branch point 105 may include corresponding valves (e.g., safety valves) that open during normal operation and close when one of branches 101 or 102 is disconnected, for example, to replace the corresponding oxygenators 20 or 21. At the ends of branches 101 and 102, a junction point 106 is provided, where branches 101 and 102 rejoin, returning to the common branch of the circuit. Although one or both of branch point 105 and junction point 106 can be configured as follows... Figures 1 to 3 The valve shown is simple, but one or both of branch point 105 and confluence point 106 can be configured as a multi-way control valve (not shown). In any case, the flow ratio between branches 101 and 102 can be changed by controlling blood pumps 11 and 13.

[0066] Typically, multi-port control valves have multiple ports. For example, a three-port control valve has three ports. They can also be referred to as selector valves and are configured to act as mixing or diverting valves. A diverting valve can be located at branch point 105 and configured to distribute the incoming volumetric flow rate to two branches 101, 102. A mixing valve can be located at confluence point 106 and configured to mix blood from branches 101, 102. These selector valves can be configured to select one or the other oxygenator 20, 21 at a time (and thus can be considered as acting as a switcher). One feasible approach is to select one branch 101, 102 (and therefore one oxygenator 20, 21) and block the other. Another feasible approach is to fill one oxygenator while its output is blocked, simultaneously emptying the other oxygenator into the patient.

[0067] Especially when combined with pump control (where the valves can be synchronized with pumps 11 and 13), this process can increase the residence time of blood in each oxygenator 20 and 21 (this residence time can be from 3 to 200 seconds before any blood clots). Therefore, the oxygen volume can be reduced, but a similar level of oxygenation can still be achieved due to the increased residence time. Using this method, the entire circuit can function as a pulsating system, altering the blood flow within the oxygenator through the filling and emptying of each cycle. Furthermore, the increased residence time allows for better bubble detection and removal.

[0068] exist Figure 1 In the embodiment of the blood pump oxygenator system 250A shown, each branch 101, 102 includes flow meters 62, 63 located before each oxygenator 20, 21 and oxygen sensors 51, 52 located after each oxygenator 20, 21. This configuration allows for the provision of integrated blood pump-oxygenator units (also referred to as “groups”; see also...) in each branch 101, 102. Figure 3 Each unit includes a pump, a flow meter, an oxygenator, and an oxygen sensor, as described in more detail below. Another oxygen sensor 50 is placed at or near the blood inlet 80 to monitor the oxygenation rate of each oxygenator 20, 21 by comparing measurements from each of the oxygen sensors 51, 52. Corresponding valves 33, 34 are provided in each branch 101, 102; valves 33, 34 may also be part of the integrated unit. It should be noted that pumps 11, 13 are preferably arranged before oxygenators 20, 21 to push blood through oxygenators 20, 21, rather than drawing blood from oxygenators 20, 21. This reduces the risk of air bubbles.

[0069] The first pressure sensor 40 is located at the blood inlet 80 to detect the input pressure of the system 250A. For proper functioning, it is crucial that high negative pressures not occur in the system 250A (particularly in pumps 11 and 13), as blood tends to evaporate and may cause bubbles. Pumps 11 and 13 can be controlled based on the measured input pressure. The second pressure sensor 41 is located at the blood outlet 90 to measure the output pressure of the blood returned to the patient P. Specifically, the pressure of the blood delivered to the patient's vein must not be too high. A flow meter 61 can also be placed near this pressure sensor 41 to obtain data on the volume of blood leaving the system 250A (e.g., in liters per minute (L / min)).

[0070] Oxygen sensors 50, 51, and 52 are provided, one at or near the blood inlet 80, and one downstream of each oxygenator 20 and 21 in each branch 101 and 102. By comparing the measured oxygen levels (more specifically, the oxygen levels before entering oxygenators 20 and 21 and the oxygen levels after flowing through oxygenators 20 and 21), an indication of the function of oxygenators 20 and 21 can be provided. This information can be used, for example, to control the amount of oxygen supplied to oxygenators 20 and 21 and / or to control pumps 11 and 13.

[0071] Figure 2 The embodiment of the blood pump oxygenator system 250B shown above is the same as the one described above. Figure 1 The embodiments described are similar. Therefore, for Figure 1 The description also applies to Figure 2 The difference lies in the addition of a reservoir 140 at the confluence point 106. Blood enters the reservoir 140 from all branches 101 and 102 via inlet port 141 and exits the device 140 via outlet port 142. Air bubbles can be expelled through vent 143.

[0072] Because the bubbles will move upwards, the outlet port 142 has an exit point 146 that faces inwards from the interior of the device 140 at a distance from the vent 143. This can be achieved, for example, by a tube that extends the outlet port 142 toward the interior of the device and toward the lower part of the device 140, with one end of the tube forming the exit point 146 for the outlet port 142. It should be understood that the device 140 must be in an upright (i.e., vertical, or at least substantially vertical) position, with the vent 143 located at the top of the device 140. At a minimum, the vent 143 must be located above the exit point 146 of the outlet port 142. Once the device 140 is fully filled, the resulting internal pressure will cause blood to exit the device 140 through the exit point 146 and the outlet port 142.

[0073] The reservoir 140 may be designed with a flexible outer shell (e.g., a flexible bag or sac). This allows the reservoir to be emptied by squeezing it, which reduces blood damage. Squeezing can be performed manually or by a mechanical squeezing device (not shown), which may be synchronized, for example, with the patient's heartbeat. The reservoir 140 may be a blood unit, in which a heater may be mounted on a rear protective cover or cap.

[0074] Additional pressure sensors 42 and 43 are located in branches 101 and 102, one upstream and one downstream of each oxygenator 20 and 21. By comparing these measured pressures (more specifically, the blood pressure before entering oxygenator 20 and oxygenator 21 and the blood pressure after flowing through oxygenators 20 and 21, respectively), an indication of the function of oxygenators 20 and 21 can be provided. For example, an increase in differential pressure may indicate that one of oxygenators 20 or 21 is blocked.

[0075] Figure 3 The embodiment of the blood pump oxygenator system 250C shown above is the same as the one described above. Figure 2 The embodiments described are similar. Therefore, for Figure 2 The description also applies to Figure 3 .However, Figure 3 A configuration with two integrated units 251, 252 is clearly shown, which can be handled as a single component (e.g., installed, removed, replaced, etc.), with a reservoir 140 located at the output of both integrated units 251, 252. Each unit 251, 252 includes blood pumps 11, 13, oxygenators 20, 21, and valves 35, 36 (e.g., check valves to prevent backflow of blood). Each unit 251, 252 may also include flow meters 62, 63 and oxygen sensors 51, 52 (see...). Figure 1 and Figure 2 Units 251 and 252 can be replaced as a whole, which facilitates system handling, allows for faster switching, and increases overall lifespan. Specifically, not only do oxygenators 20 and 21 wear out over time, but blood pumps 11 and 13 also wear out over time, which is why it is advantageous to make blood pumps 11 and 13 disposable as well. Corresponding valves (e.g., safety valves) can be included in branch point 105, for example, if one of pumps 11 or 13 stops or shuts down to disconnect the corresponding branch 101 or 102 for maintenance or replacement, the corresponding valve is closed. Parameters indicating the oxygenator status (“health”) can be provided, such as the motor current of pumps 11 and 13, data from pressure sensor 41, or the oxygenation level measured by oxygen sensor 51. An alarm can be output if the parameters indicate that integrated units 251 and 252 must be replaced.

[0076] Pumps 11 and 13 can be controlled in reverse and pulsating modes as described above, particularly by pump control unit 290. The corresponding exemplary motor speeds M1 and M2 of pumps 11 and 13 are... Figure 4The graph illustrates this. More specifically, when blood flow increases in one oxygenator 20 (motor speed of pump 11 increases), blood flow decreases in the other oxygenator 21 (motor speed of pump 13 decreases), and vice versa. The curves show motor speeds M1 and M2 rising and falling between minimum and maximum speeds, respectively. This allows for longer-term enhanced oxygenation in one oxygenator while one oxygenator is being emptied, thus ensuring that blood flow to the patient is not affected.

[0077] System 250C includes valves 35 and 36 located in each integrated unit 251, 252 and between the corresponding blood pumps 11, 13 and the corresponding oxygenators 20, 21 to prevent blood from flowing backward from oxygenators 20, 21 to blood pumps 11, 13. During reverse and pulsating operation of pumps 11, 13, controlled by pump control unit 290, pressure in the oxygenator with higher blood flow may push blood backward in the other oxygenator. This can be prevented by setting valves 35, 36, which can be configured as simple check valves (one-way valves).

[0078] Oxygenators 20 and 21 are connected to an oxygen tank / oxygen generator 260 to increase blood oxygen levels and to an air compressor 270 to supply compressed (filtered ambient) air to oxygenators 20 and 21, thereby further removing CO2 from the blood. A gas control unit 280 is provided to control a four-way mixing valve 281 to change the ratio between oxygen and air, and specifically allows switching between oxygen and air supplied to oxygenators 20 and 21. This reduces the required oxygen volume, allowing the use of small oxygen tanks or portable lightweight oxygen generators, further increasing the mobility of the system 250C. Oxygenators 20 and 21 can be repeatedly flushed with air supplied at, for example, a rate of 15 L / min. The gas control unit 280 can be synchronized with a pump control unit 290. It should be understood that this device can also be applied to… Figure 1 and Figure 2 In systems 250A and 250B.

[0079] Figure 5 The connections of integrated unit 251 (and similarly integrated unit 252) are schematically illustrated and can be referred to as quick-connect. Various inputs and outputs (power (DC), blood, oxygen) can be connected to and disconnected from socket 300 in a single step. Locks or clamps 301, 302 may be provided, which, once in place in socket 300, can close around group 251 to securely hold group 251 in place with all connections established (directions of movement during connection / disconnection are indicated by arrows, and locked positions by dashed lines).

[0080] To provide further mobility options, a carrying device in the form of a trolley 500 can be provided, such as... Figure 6 As shown. The trolley 500 is configured to carry the blood pump-oxygenator system 600, and in Figure 6 Figure a shows the system 600 without its components in place. System 600 can be any system described herein. The trolley 500 can be moved around using wheels 508. The trolley 500 has carrying features, such as hooks 501, for receiving corresponding hooks 502 of system 600 (see Figure 1). Figure 6 b, showing the placement of system 600). Figure 6 c shows a system 600 that is placed and locked by fastening devices 504, 507.

[0081] Once the system 600 is mounted on the cart 500, the battery of the system 600 can be charged via power connection 505 and corresponding plug 509. A heating device (e.g., a ceramic heating plate 503) that can contact the system 600 can be provided. Another heating option for blood can be provided through heat transfer between inlet and outlet tubes (denoted as 506) arranged in parallel. An alarm can be triggered if the blood temperature in the system 600 drops below a critical level, for example, below 35°C. The catheter (or tubing) connecting the system to the patient (connected to the inlet 80 and outlet 90) can be of sufficient length to allow the patient to move around while the system 600 is placed on the cart 500. A suitable length could be, for example, 2 m to 5 m. Once the system is placed, for example, on the cart 500, a device for coiling and storing the tubing can be provided.

[0082] Figure 7 The system 600 is schematically shown connected to a console via cable 701. Cable 701 can be any cable, such as a magnetic cable. The console 700 can be a fixed device and may provide a display (e.g., a touchscreen) for controlling the system 600, setting the system 600, reading parameters, etc. It should be understood that the console 700 is not necessary for the normal operation of the system 600, but can facilitate access to the system when necessary, for example, by a doctor or other medical personnel.

[0083] Figure 8 An electric wheelchair 800 with a trolley 900 is shown. The wheelchair 900 includes a fixing part 901 and a moving part 902. The fixing part 901 is fixed to the wheelchair 900 and includes a high-capacity battery 903, an oxygen concentrator 904, an air pump, and a power supply. This power supply should be connected to mains power when it is used to charge the battery 903 and heat the blood circulation. In addition... Figure 3In addition to the circuit specifically shown, the moving part 902 also includes a small oxygen tank 905 or a portable battery-powered oxygen concentrator, a small battery-powered air compressor 906, and a lightweight battery pack. The moving part 902 is connected to the fixed part via suitable connectors 907, 908 and can be detached from the fixed part 901. Then, when the patient wants to move off the electric wheelchair 800, the moving part can be carried by the patient as a backpack to function as a stand-alone system for a period of time. The wheelchair 800 can be used as a recliner on which the patient can sleep. In this case, the trolley 900 can be unlocked and turned to the side of the wheelchair 800 or pulled away from the wheelchair 800.

[0084] Now for reference Figures 9 to 14 Another embodiment of wheelchair 1000 is described herein. It should be understood that wheelchair 1000 need not be configured for any of the blood pump-oxygenator systems described herein, but can be specifically configured for situations where such a system is not available. Specifically, wheelchair 1000 can be configured to provide typical functionality of a fixed ICU, in order to provide mobility even for critically ill patients. Thus, a typical medical unit (not shown) can be attached to or carried by a wheelchair or corresponding support device. Such a unit may specifically include an oxygen supply unit and a power supply unit for independently supplying oxygen and power as needed for treatment. Although not explicitly shown, wheelchair 1000 can be an electric wheelchair.

[0085] Figure 9 The image shows a wheelchair 1000 in a first configuration, which is a normal sitting posture configuration with the backrest 1001 in an upright position. Folded-down auxiliary wheels 1004 are located on top of the backrest 1001. When the wheelchair 1000 is in... Figure 10 In the second configuration shown, the wheels 1004 provide additional support specifically for the patient's upper body as they recline against the backrest 1001. In this bed-like configuration, the backrest 1001, seating area 1002, and leg / footrest 1003 form a flat surface. The wheelchair 1001 also has side sections 1005, 1006, and 1007, which fold upwards in both the first and second configurations to provide more lateral support and safety for the patient. However, in the third configuration, the side sections 1005, 1006, and 1007 can fold downwards, as shown... Figure 11 As shown. In this enhanced bed-like configuration, the lying area is expanded. And for hygiene and / or comfort, additional coverings 1008 can be provided, such as... Figure 12 As shown.

[0086] Figure 13The wheelchair 100 in its first configuration is shown again. However, a lift-type support device 1010 is attached to the back of the wheelchair 1000. The support device 1010 is configured to carry any type of equipment, such as medical ICU equipment (including, for example, oxygen cylinders, oxygen concentrators, batteries, etc. (not shown)). Figure 14 The support device 1010 is shown separately. It has a base 1011, which can be of the platform or frame type, to support the aforementioned components. It is shown in its lowest position, where it is convenient to load heavy components. The base 1011 and the components thereon can be lifted upwards via a lifting section 1012 to improve the mobility of the wheelchair 1000. As indicated by the double-headed arrows, the base 1011 can be moved up and down via the lifting section 1012. This can be conveniently achieved via a remote control 1009 (see...). Figure 13 ).

[0087] Figure 15 An embodiment of the reservoir 150 is shown. It should be understood that it can replace... Figure 3 (or Figure 2 The system 10 shown is a reservoir 140. The device 150 is shown in a cross-sectional view (a) and views from different angles (b, c).

[0088] The above reference Figure 2 The described reservoir 140 may have a flexible, bag-like construction and must be in an upright position during operation to keep the vent upwards as described above, with the exit point 146 of the outlet port 143 located below the vent 143. However, particularly regarding movement options, the position and orientation may change as the patient moves (using the removable unit 902). Therefore, it may not always be possible to ensure that the vent 143 of the device 140 is facing upwards. Figure 15 The design of the reservoir 150 shown ensures normal function regardless of its orientation. Furthermore, the function of device 150 is similar to that of device 140.

[0089] The reservoir 150 has an inlet port 151. Depending on the number of oxygenators in the blood pump-oxygenator system to which the device 150 is intended to be used, more than one inlet port may be provided. The outlet port 152 has an exit point 156, which is substantially located at the center of the device 150. A plurality of vents 153 are arranged to be distributed along the outer circumference of the device 150. The number and location of the vents 153 can vary, as long as at least one vent 153 is substantially located at the top of the device 150 in any orientation of the device 150. This configuration ensures that in any orientation of the device 150, at least one vent 153 is located above the exit point 156 of the outlet port, allowing air bubbles to escape. To trap impurities (such as blood clots) and prevent these impurities from being transported through the system, a filter 157 (such as a mesh or sponge structure) may be provided to cover the exit point 156 of the outlet port 152.

[0090] Device 150 is spherical, particularly spherical. However, it should be understood that any shape is conceivable as long as the device provides the described plurality of exhaust ports, one or more inlet ports, and outlet ports. To allow device 150 to be compressed as described above with respect to device 140, it may have a flexible housing 154. A biasing device (such as a metal ring 155) may be provided to allow device 150 to return to its original shape. However, it should be understood that device 150 may alternatively have a rigid housing. In any case, once device 150 is fully filled, blood will be expelled from outlet port 142.

[0091] Figure 16 Another embodiment of reservoir 160 is shown. It should be understood that reservoir 160 can be used in place of reservoir 140 or reservoir 150 described above, and can be used accordingly in any system. Like other reservoirs, reservoir 160 can also be used as a bubble trap, as described below.

[0092] The reservoir 160 has two inlet ports 161 for receiving blood from the oxygenators (it should be understood that the number of inlet ports may vary depending on the system configuration, more specifically, the number of oxygenators). The inlet ports 161 are located in the middle section of the reservoir 160 and above the outlet port 162 (particularly when the reservoir 160 is in an upright position). This configuration, with the exit point 166 of the outlet port located in the lower part of the reservoir 160, ensures that any air bubbles in the blood entering the reservoir 160 do not directly reach the outlet port 162 (more specifically, the exit point 166 of the outlet port 162). A shield 165 is provided around the area where the exit point 166 is located to guide the incoming blood away from the exit point 166. The incoming blood is directed to the upper part 164 of the reservoir, where an vent 163 is provided to expel any air bubbles. Similar to the spherical reservoir 150 described above, the upper part 164 is circular and has several vents 163 at different locations to ensure that air bubbles can leave the reservoir 160 even if it is not in a completely upright position. The air bubbles will then escape through a corresponding vent 163 located at the highest position. To trap any impurities (such as blood clots) and prevent them from being transported through the system, a filter 167 (e.g., a mesh or sponge structure) can be provided at the exit point 166 of the outlet port 162.

[0093] The described system can be used in conjunction with any cardiopulmonary bypass (CPB) system or any extracorporeal membrane oxygenation (ECMO) system to increase blood oxygenation with a smaller oxygenator size. Using a smaller oxygenator will reduce the circuit loading volume, thereby reducing blood dilution and increasing the blood's ability to carry more oxygen to the patient. Furthermore, this system will allow the use of ambient air instead of pure oxygen, and will achieve similar levels of oxygenation. Eliminating the use gas with high oxygen concentrations will eliminate the risks associated with the flammability of concentrated oxygen, and will therefore allow the system to be used in environments outside of hospital facilities, such as ambulances and environments where high oxygen concentrations are not available.

[0094] It should be understood that, according to any of the embodiments described herein, an electronic controller may be required to control system characteristics (e.g., pump speed, oxygen delivery volume, valve opening and closing) and diagnostic sensors (pressure sensors, oxygen sensors, flow meters) indicating appropriate system performance. More specifically, system components may be controlled in such a way that the system can be automatically controlled by corresponding feedback loops, for example, by using sensor data from diagnostic sensors to control one or more pumps and one or more valves. Details of such controllers are well known to those skilled in the art.

[0095] While at least one exemplary embodiment of the invention has been described above, it should be noted that numerous variations exist. Furthermore, it should be understood that the described exemplary embodiments are merely non-limiting examples of how the invention can be implemented and are not intended to limit the scope, application, or configuration of the apparatus and methods described herein. Rather, the foregoing description will provide those skilled in the art with constructions for implementing at least one exemplary embodiment of the invention, wherein it should be understood that various changes can be made to the function and arrangement of the elements of the exemplary embodiments without departing from the subject matter defined by the appended claims and their legal equivalents.

Claims

1. A blood pump-oxygenator system (250A, 250B, 250C) for increasing perfusion and oxygen levels in a patient (P), comprising: A blood inlet (80) and a blood outlet (90) connected to form a loop, the loop being operable as a cardiopulmonary bypass system suitable for extracorporeal processing of a patient's blood; a first blood pump (11) and a first oxygenator (20), wherein the first blood pump (11) is configured to deliver blood from the patient (P) to the blood inlet (80) via the loop, through the first oxygenator (20), and back to the patient (P) from the blood outlet (90), wherein the system further includes: A second blood pump (13) and a second oxygenator (21), wherein the second blood pump (13) is configured to deliver blood from the patient (P) to the blood inlet (80) via the circuit, through the second oxygenator (20), and out of the blood outlet (90) back to the patient (P), wherein the circuit includes a first branch (101) and a second branch (102) arranged in parallel with each other, the first branch (101) housing the first blood pump (11) and the first oxygenator (20), and the second branch (102) housing the second blood pump (13) and the second oxygenator (21); and A pump control unit (290) wherein the first blood pump (11) and the second blood pump (13) are configured to be controlled by the pump control unit (290) to increase or decrease the blood flow through the corresponding oxygenators (20, 21) by changing the ratio of the blood flow through the first oxygenator (20) and the second oxygenator (21).

2. The blood pump-oxygenator system according to claim 1, wherein the first blood pump (11) and the second blood pump (13) are configured to be controlled by the pump control unit (290) to increase or decrease the blood flow through the corresponding oxygenators (20, 21) in a synchronous and reverse manner.

3. The blood pump-oxygenator system according to claim 1 or 2, wherein the first blood pump (11) and the second blood pump (13) are configured to be controlled by the pump control unit (290) to increase or decrease the blood flow through the corresponding oxygenator (20, 21) while maintaining the total flow at the desired level.

4. The blood pump-oxygenator system according to any one of the preceding claims further includes a gas control unit (280), wherein the gas control unit (280) is configured to control the oxygen flow to the first oxygenator (20) and the second oxygenator (21) by changing the ratio of the flow rates of oxygen and air flowing through the first oxygenator (20) and the second oxygenator (21), respectively.

5. The blood pump-oxygenator system according to claim 4, wherein the gas control unit (280) is configured to synchronize with the pump control unit (290).

6. The blood pump-oxygenator system according to any one of the preceding claims further includes an oxygen generator (260) and an air compressor (270), the oxygen generator being used to supply oxygen to the first oxygenator (20) and the second oxygenator (21), and the air compressor being used to supply air to the first oxygenator (20) and the second oxygenator (21).

7. The blood pump-oxygenator system according to any one of the preceding claims further includes valves (33, 34) in each branch (101, 102) and between the corresponding blood pump (11, 13) and the corresponding oxygenator (20, 21) for preventing blood from flowing in the reverse direction from the oxygenator (20, 21) to the blood pump (11, 13).

8. The blood pump-oxygenator system according to any one of the preceding claims, wherein the circuit comprises: A branch point (105) that diverts blood flow in the circuit to two branches (101, 102); and a confluence point (105) where at least two branches (101, 102) converge, wherein at least one of the branch point (105) and the confluence point (106) is configured as a multi-way control valve (130, 131) operable to select at least one of the two branches (101, 102) for blood flow.

9. The blood pump-oxygenator system according to claim 8, wherein a reservoir (140; 150; 160) is provided at the confluence point (106), the reservoir (140; 150; 160) comprising: At least two inlet ports (141; 151; 161), wherein each branch (101, 102) terminates at the corresponding inlet port (141; 151; 161) into the reservoir (140; 150; 160); an outlet port (142; 152; 162) for allowing blood to exit the reservoir (140; 150; 160); and at least one vent (143; 153; 163) configured to expel air bubbles from the blood in the reservoir (140; 150; 160), wherein the outlet port extends toward the interior of the reservoir (140; 150; 160).

10. The blood pump-oxygenator system according to any one of the preceding claims further includes a first oxygen sensor (50), a second oxygen sensor (51), and a third oxygen sensor (52), all of which are configured to measure the oxygen level in the blood, wherein the first oxygen sensor (50) is located upstream of the first oxygenator (20) and the second oxygenator (21), wherein the second oxygen sensor (51) is located in the first branch (101) and downstream of the first oxygenator (20), thereby obtaining the oxygenation rate of the first oxygenator (20) by comparing the oxygen level measured by the first oxygen sensor (50) and the oxygen level measured by the second oxygen sensor (51), and wherein the third oxygen sensor (52) is located in the second branch (102) and downstream of the second oxygenator (21), thereby obtaining the oxygenation rate of the second oxygenator (21) by comparing the oxygen level measured by the first oxygen sensor (50) and the oxygen level measured by the third oxygen sensor (52).

11. The blood pump-oxygenator system according to any one of the preceding claims further includes at least one of a first pressure sensor (40) and a second pressure sensor (41), wherein the first pressure sensor (40) is located at the blood inlet (80) and configured to measure the input pressure of the circuit, and the second pressure sensor (41) is located at the blood outlet (90) and configured to measure the output pressure of the circuit, wherein the first blood pump (11) and the second blood pump (13) are configured to be controlled by the pump control unit (290) to set the pumping rate of the first blood pump (11) and the second blood pump (13) according to the measured input pressure, wherein preferably, the pumping rate increases when the input pressure drops to a predetermined threshold.

12. The blood pump-oxygenator system according to claim 11 further includes a third pressure sensor (42) and a fourth pressure sensor (43), wherein the third pressure sensor (42) is located in the first branch (101) and upstream of the first oxygenator (20), and the fourth pressure sensor (43) is located in the second branch (102) and upstream of the second oxygenator (21), thereby detecting pressure drops caused by the first oxygenator (20) and the second oxygenator (21) respectively by comparing the pressure measured by the first pressure sensor (40) with the pressure measured by the third pressure sensor (42) and the fourth pressure sensor (43).

13. The blood pump-oxygenator system according to any one of the preceding claims further includes at least one flow meter for measuring blood flow, the at least one flow meter including at least one of a first flow meter (60) and a second flow meter (61), the first flow meter (60) being disposed at the blood inlet (80) and configured to measure blood flow from the patient (P); and the second flow meter (61) being disposed at the blood outlet (90) and configured to measure blood flow returned to the patient (P).

14. The blood pump-oxygenator system according to any one of the preceding claims, wherein the first blood pump (11) and the first oxygenator (20) are configured as a first integrated unit (251), and the second blood pump (13) and the second oxygenator (21) are configured as a second integrated unit (252).

15. A support device (500; 900; 1010) configured to support at least a portion of a blood pump-oxygenator system according to any one of the preceding claims, wherein the support device (500; 900; 1010) is configured to be attached to a wheelchair (800; 1000) and further includes an integrated locking mechanism configured to be connected to a blood inlet (80), a blood outlet (90), an oxygen inlet, an oxygen outlet, and a power port of the blood pump-oxygenator system.

Images