Integrated cardiopulmonary auxiliary equipment

Abstract

The invention discloses integrated cardiopulmonary auxiliary equipment, which relates to the technical field of medical instruments and comprises a shell, and a pulsating pump, a temperature changing module and an oxygenation module which are arranged in the shell and are sequentially arranged from an inner ring to an outer ring, one end of the pulsating pump is provided with a vein connecting pipe extending out of one end of the shell, and the other end is communicated with the temperature changing module. An artery connecting pipe communicated with the oxygenation module is arranged at the other end of the shell; a pulsating part suitable for expansion or contraction is arranged in the pulsating pump; the temperature changing module comprises a temperature changing channel communicated between the pulsating pump and the oxygenation module. By expanding the pulsation piece, blood in the pulsation pump is extruded to flow into the temperature changing module; the pulsating piece contracts, and blood enters the pulsating pump through the vein connecting pipe; by means of periodic expansion and contraction of the pulsating piece, pulsating blood flow simulating physiology is generated, and the tissue perfusion and organ protection effects are improved. Due to the integrated design that a plurality of modules are arranged in the shell, the size of the equipment is smaller, the occupied area is small, modular arrangement is achieved, and installation is more convenient.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an integrated cardiopulmonary assist device. Background Art

[0002] Mechanical circulatory assistance (MAC) refers to various methods that can provide hemodynamic support for patients with heart or lung failure, which currently mainly include: cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO) and mechanical circulatory support (MCS). CPB extracorporeal circulation mainly consists of an artificial blood pump and a gas exchange device (oxygenator), which can replace heart and lung function during cardiac surgery. ECMO extracorporeal membrane oxygenation is a modified CPB extracorporeal circulation technology that can provide extracorporeal life support for patients with severe heart and lung failure for days to weeks. Ventricular assist devices (VADs) are often used in patients with simple heart failure and can provide mechanical circulatory support for the left ventricle (LVAD), right ventricle (RVAD) or biventricular heart failure (BiVAD) for weeks to years. The total artificial heart (TAH) is a special form of MCS, which can be used as an over-treatment during the waiting period for heart transplantation or as the terminal treatment for some patients with biventricular heart failure.

[0003] Regardless of the above-mentioned type of MAC, human blood will inevitably continue to be exposed to the artificial non-biological material surface in the mechanical assisted circulatory system and the non-physiological shear stress (NPSS) caused by the mechanical pump. These two factors can cause blood cell damage and protein activation, leading to the activation of the coagulation system, fibrinolysis system, and complement system and causing immune system dysfunction [7-10]. Although the understanding of the pathophysiological mechanisms of patients supported by CPB, ECMO or VAD has been increasing in recent years, various anticoagulation strategies have been applied, and the design of pumps and oxygenators has been improved, the above two aspects of damage cannot be ignored in clinical practice. Moreover, the blood pumps currently used in various MAC systems are mostly roller pumps or centrifugal pumps. The blood flow generated by these two types of blood pumps is non-pulsatile blood flow. Studies have shown that compared with this type of non-pulsatile blood flow, pulsatile blood flow is closer to physiological blood flow and has better effects on tissue perfusion and organ protection.

[0004] Mechanical circulatory assistance (MAC) can provide effective circulatory and respiratory support, especially for patients with heart failure and lung failure. The main problems it faces are: continuous exposure of blood to non-biological material surfaces and non-physiological shear stress; activation and damage of blood cells; secondary significant systemic inflammatory response, etc. Current mechanical assist devices are mainly based on non-pulsatile horizontal blood flow, but this method is inferior to pulsatile blood flow in terms of tissue perfusion and organ protection; and most of the cardiopulmonary assist devices currently used are split designs, which significantly increase the system footprint and installation complexity. Summary of the invention

[0005] Therefore, the present invention aims to solve the problems in the prior art of cardiopulmonary circulation devices, such as horizontal blood circulation, poor effect on tissue perfusion and organ protection, split design of cardiopulmonary assist devices, large footprint and complex installation, so as to provide an integrated cardiopulmonary assist device.

[0006] In order to solve the above technical problems, the technical solution of the present invention is as follows:

[0007] An integrated cardiopulmonary assist device comprises a shell, a pulsating pump, a temperature-variable module and an oxygenation module which are arranged in the shell and in sequence from the inner circle to the outer circle; a venous connecting tube extending out of one end of the shell is arranged at one end of the pulsating pump, and the other end of the pulsating pump is connected to the temperature-variable module; an arterial connecting tube suitable for extending out of the other end of the shell is arranged at the other end of the shell; a pulsating element suitable for expansion or contraction is arranged on the inner side wall of the pulsating pump; the oxygenation module is connected to the arterial connecting pipeline; the temperature-variable module comprises a temperature-variable channel connected between the pulsating pump and the oxygenation module.

[0008] Furthermore, the temperature-changing module also includes a temperature-changing tube wrapped around the outer periphery of the temperature-changing channel, and the temperature-changing tube is provided with a liquid inlet at one end and a liquid outlet at the other end.

[0009] Furthermore, the temperature-changing module also includes a temperature-changing tube, and the temperature-changing channel is arranged around the outer circumference of the temperature-changing tube.

[0010] Furthermore, an inlet one-way valve is provided at one end of the venous connecting tube close to the pulsating pump.

[0011] Furthermore, an outlet one-way valve is provided at one end of the pulsating pump close to the arterial connecting tube, and the inlet of the variable temperature channel is connected to the outlet of the outlet one-way valve.

[0012] Furthermore, the pulsating member is provided with an air tube extending out of the shell, and one end of the air tube away from the pulsating member is suitable for being connected to an inflatable structure.

[0013] Furthermore, the oxygenation module includes an oxygenation channel and an air supply pipe connected to the oxygenation channel, one end of the oxygenation channel is connected to the temperature variable module, and the other end is connected to the arterial connecting tube.

[0014] Furthermore, an air inlet is provided at one end of the air supply pipe, and an exhaust port is provided at the other end. The position where the air supply pipe is connected to the temperature variable module is arranged close to the air inlet, and the position where the air supply pipe is connected to the arterial connecting pipe is arranged close to the exhaust port.

[0015] Furthermore, a plurality of hollow fibers communicating with the air inlet are provided in the oxygenation channel.

[0016] Furthermore, the pulsating member is an airbag.

[0017] The technical solution of the present invention has the following advantages:

[0018] 1. The integrated cardiopulmonary assist device provided by the present invention, human blood flows out from the veins, enters the pulsating pump through the venous connecting tube, and then enters the temperature-changing module at one end of the temperature-changing channel to be heated so that the blood maintains a temperature suitable for entering the human body, and then flows from the other end of the temperature-changing channel to the arterial connecting tube, and then is transported back to the human body through the arterial connecting tube. Before the blood enters the temperature-changing module from the pulsating pump, the pulsating element is in a contracted state. Before the blood enters the temperature-changing module from the pulsating pump, the pulsating element is expanded, so that the blood in the pulsating pump flows into the temperature-changing module when the space is narrowed and squeezed, thereby completing a cycle of blood circulation; in the next cycle, the pulsating element contracts, and the blood enters the pulsating pump again through the venous connecting tube; this cycle is repeated, and the periodic expansion and contraction of the pulsating element generates a pulsating blood flow that simulates physiological properties. Compared with horizontal blood flow, the pulsating blood flow has a better effect on tissue perfusion and organ protection, and can effectively reduce the incidence of various adverse reactions and complications during mechanical assisted circulation. At the same time, the pulsatile pump, oxygenation module and temperature variable module are all arranged inside the shell, which avoids the exposure of blood to the surface of non-biological materials and non-physiological shear stress, and avoids the risk of activation and damage of blood cells and subsequent obvious systemic inflammatory response; this integrated design makes the device smaller in size and occupies less usable area, and is more suitable for small patients, such as children, newborns, etc., effectively expanding the scope of use of the device; the modular setting makes it more convenient to use and install.

[0019] 2. The integrated cardiopulmonary assist device provided by the present invention, the temperature-changing module also includes a temperature-changing tube wrapped around the outer periphery of the temperature-changing channel, one end of the temperature-changing tube is provided with a liquid inlet, and the other end is provided with a liquid outlet. In this way, the blood in the temperature-changing channel can be kept warm or heated by setting a liquid of a required temperature in the temperature-changing tube; at the same time, the temperature-changing tube is arranged on the outer periphery of the temperature-changing channel, which can reduce the loss of blood temperature in the temperature-changing channel and improve the heating and heat preservation effect.

[0020] 3. The integrated cardiopulmonary assist device provided by the present invention, the temperature-changing module also includes a temperature-changing tube, and the temperature-changing channel is arranged around the outer circumference of the temperature-changing tube. Such an arrangement can increase the blood flow distance, increase the blood heating distance and time, and reduce the heating and heat preservation energy consumption.

[0021] 4. In the integrated cardiopulmonary assist device provided by the present invention, an inlet check valve is arranged at one end of the venous connection tube close to the pulsating pump. This arrangement can prevent the pulsating element from squeezing the blood in the pulsating pump back into the venous connection tube when it expands, causing backflow and danger to the transfusion patient.

[0022] 5. In the integrated cardiopulmonary assist device provided by the present invention, an outlet check valve is provided at one end of the pulsating pump close to the arterial connecting tube, and the inlet of the variable temperature channel is connected to the outlet of the outlet check valve. This arrangement can prevent the blood in the variable temperature channel from flowing back into the pulsating pump when the pulsating element contracts.

[0023] 6. In the integrated cardiopulmonary assist device provided by the present invention, a plurality of hollow fibers connected to the air inlet are arranged in the oxygenation channel, so that the blood entering the hollow fibers and oxygen can be fully exchanged with each other, thereby providing oxygen to the blood. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0025] Figure 1 A schematic diagram of the internal structure of an integrated cardiopulmonary assist device provided in an embodiment of the present invention.

[0026] Explanation of the reference numerals: 1. Shell; 2. Pulsatile pump; 3. Variable temperature module; 4. Oxygenation module; 5. Venous connecting tube; 6. Arterial connecting tube; 7. Inlet check valve; 8. Outlet check valve; 9. Trachea; 10. Air bag; 11. Water inlet; 12. Water outlet; 13. Air inlet; 14. Exhaust outlet. DETAILED DESCRIPTION

[0027] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0028] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0029] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0030] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0031] like Figure 1 An integrated cardiopulmonary assist device is shown, comprising a shell 1, a pulsating pump 2, a temperature-variable module 3 and an oxygenation module 4 arranged in sequence from the inner circle to the outer circle in the shell 1; a venous connecting tube 5 extending out of one end of the shell 1 is arranged at one end of the pulsating pump 2, and the other end of the pulsating pump 2 is connected to the temperature-variable module 3; an arterial connecting tube 6 suitable for extending out of the other end of the shell 1 is arranged at the other end of the shell 1; a pulsating member suitable for expansion or contraction is arranged on the inner wall of the pulsating pump 2; the oxygenation module 4 is connected to the arterial connecting tube 6; the temperature-variable module 3 includes a temperature-variable channel connected between the pulsating pump 2 and the oxygenation module 4.

[0032] During use of this integrated cardiopulmonary assist device, human blood flows out from the veins, enters the pulsating pump 2 through the venous connecting tube 5, and then enters the temperature-changing module 3 at one end of the temperature-changing channel to be heated so that the blood maintains a temperature suitable for entering the human body. The blood then flows from the other end of the temperature-changing channel to the arterial connecting tube 6, and is then returned to the human body through the arterial connecting tube 6. Before the blood enters the temperature-changing module 3 from the pulsating pump 2, the pulsating element is in a contracted state. Before the blood enters the temperature-changing module 3 from the pulsating pump 2, the pulsating element is expanded so that the blood in the pulsating pump 2 flows into the temperature-changing module 3 when the space becomes narrow and is squeezed, thereby completing a cycle of blood circulation. During the next cycle, the pulsating element contracts, and the blood enters the pulsating pump again through the venous connecting tube 5. This cycle is repeated, and a pulsating blood flow that simulates physiological properties is generated through the periodic expansion and contraction of the pulsating element. Compared with horizontal bleeding, pulsating blood flow has a better effect on tissue perfusion and organ protection, and can effectively reduce the incidence of various adverse reactions and complications during mechanical assisted circulation. At the same time, the pulsating pump 2, oxygenation module 4 and temperature variable module 3 are all arranged inside the shell 1, which avoids the exposure of blood to the surface of non-biological materials and non-physiological shear stress, and avoids the risk of activation and damage of blood cells and subsequent obvious systemic inflammatory response; this integrated design makes the device smaller in size and occupies a smaller area, and is more suitable for small patients, such as children, newborns, etc., effectively expanding the scope of use of the device; the modular setting makes it more convenient to use and install.

[0033] In this embodiment, the temperature-changing module 3 also includes a temperature-changing tube wrapped around the periphery of the temperature-changing channel, and the temperature-changing tube is provided with a liquid inlet at one end and a liquid outlet at the other end. With such a configuration, the blood in the temperature-changing channel can be kept warm or heated by setting a liquid of a required temperature in the temperature-changing tube; at the same time, the temperature-changing tube is arranged around the periphery of the temperature-changing channel, which can reduce the loss of blood temperature in the temperature-changing channel and improve the heating and heat preservation effect. In an alternative embodiment, the temperature-changing channel is arranged around the periphery of the temperature-changing tube. With such a configuration, the blood flow distance can be increased, the blood heating distance and time can be increased, and the heating and heat preservation energy consumption can be reduced.

[0034] In this embodiment, an inlet non-return valve 7 is provided at one end of the venous connecting tube 5 close to the pulsating pump 2. This arrangement can prevent the blood in the pulsating pump 2 from being squeezed back into the venous connecting tube 5 when the pulsating element expands, thereby preventing the blood from flowing back and causing danger to the transfusion patient.

[0035] In this embodiment, an outlet check valve 8 is provided at one end of the pulsating pump 2 close to the arterial connecting tube 6, and the inlet of the variable temperature channel is connected to the outlet of the outlet check valve 8. This arrangement can prevent the blood in the variable temperature channel from flowing back into the pulsating pump 2 when the pulsating element contracts.

[0036] In this embodiment, the pulsating element is provided with an air tube 9 extending out of the housing 1, and one end of the air tube 9 away from the pulsating element is suitable for connecting with an inflatable structure. Specifically, the pulsating element is an air bag 10. The air bag 10 is suitable for inputting inert gas.

[0037] In this embodiment, the oxygenation module 4 includes an oxygenation channel and an air supply pipe 9 connected to the oxygenation channel, one end of the oxygenation channel is connected to the temperature-changing module 3, and the other end is connected to the arterial connection pipe 6. Specifically, an air inlet 13 is provided at one end of the air supply pipe 9, and an exhaust port 14 is provided at the other end. The position where the air supply pipe 9 is connected to the temperature-changing module 3 is arranged close to the air inlet 13, and the position where the air supply pipe 9 is connected to the arterial connection pipe 6 is arranged close to the exhaust port 14.

[0038] In this embodiment, a plurality of hollow fibers are provided in the oxygenation channel and are connected to the air inlet 13. This arrangement allows sufficient gas exchange between the blood and oxygen entering the hollow fibers, thereby providing oxygen to the blood.

[0039] In summary, during the use of this integrated cardiopulmonary assist device, human blood flows out from the veins, enters the pulsating pump 2 through the venous connecting tube 5, and then enters the temperature-changing module 3 at one end of the temperature-changing channel to be heated so that the blood maintains a temperature suitable for entering the human body. The blood then flows from the other end of the temperature-changing channel to the arterial connecting tube 6, and is then returned to the human body through the arterial connecting tube 6. Before the blood enters the temperature-changing module 3 from the pulsating pump 2, the pulsating element is in a contracted state. Before the blood enters the temperature-changing module 3 from the pulsating pump 2, the pulsating element is expanded so that the blood in the pulsating pump 2 flows into the temperature-changing module 3 when the space is narrowed and squeezed, thereby completing a cycle of blood circulation; in the next cycle, the pulsating element contracts, and the blood enters the pulsating pump again through the venous connecting tube 5; this cycle is repeated, and a pulsating blood flow that simulates physiological properties is generated through the periodic expansion and contraction of the pulsating element. Compared with horizontal bleeding, the pulsating blood flow has a better effect on tissue perfusion and organ protection, and can effectively reduce the incidence of various adverse reactions and complications during mechanical assisted circulation. At the same time, the pulsating pump 2, oxygenation module 4 and temperature variable module 3 are all arranged inside the shell 1, which avoids the exposure of blood to the surface of non-biological materials and non-physiological shear stress, and avoids the risk of activation and damage of blood cells and subsequent obvious systemic inflammatory response; this integrated design makes the device smaller in size and occupies a smaller area, and is more suitable for small patients, such as children, newborns, etc., effectively expanding the scope of use of the device; the modular setting makes it more convenient to use and install.

[0040] Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the scope of protection of the invention.

Claims

1. An integrated cardiopulmonary assist device, characterized in that: The invention comprises a housing (1), a pulsating pump (2) arranged in the housing (1) and arranged in sequence from the inner circle to the outer circle, a temperature-variable module (3) and an oxygenation module (4); one end of the pulsating pump (2) is provided with a venous connection tube (5) extending out of one end of the housing (1), and the other end of the pulsating pump (2) is connected to the temperature-variable module (3); the other end of the housing (1) is provided with an arterial connection tube (6) suitable for extending out of the other end of the housing (1); a pulsating element suitable for expansion or contraction is provided on the inner wall of the pulsating pump (2); the oxygenation module (4) is connected to the arterial connection tube (6); the temperature-variable module (3) comprises a temperature-variable channel connected between the pulsating pump (2) and the oxygenation module (4).

2. The integrated cardiopulmonary assist device according to claim 1, characterized in that: The temperature-changing module (3) further comprises a temperature-changing tube wrapped around the outer periphery of the temperature-changing channel, wherein one end of the temperature-changing tube is provided with a liquid inlet, and the other end is provided with a liquid outlet.

3. The integrated cardiopulmonary assist device according to claim 1, characterized in that: The temperature-changing module (3) also includes a temperature-changing tube, and the temperature-changing channel is arranged around the outer circumference of the temperature-changing tube.

4. The integrated cardiopulmonary assist device according to claim 1, characterized in that: An inlet one-way valve (7) is provided at one end of the venous connecting tube (5) close to the pulsating pump (2).

5. The integrated cardiopulmonary assist device according to claim 1, characterized in that: An outlet one-way valve (8) is provided at one end of the pulsating pump (2) close to the arterial connecting tube (6), and the inlet of the temperature-changing channel is connected to the outlet of the outlet one-way valve (8).

6. The integrated cardiopulmonary assist device according to claim 1, characterized in that: The pulsating member is provided with an air tube (9) extending out of the housing (1); one end of the air tube (9) away from the pulsating member is suitable for being connected to an inflatable structure.

7. The integrated cardiopulmonary assist device according to claim 1, characterized in that: The oxygenation module (4) comprises an oxygenation channel and an air delivery pipe (9) connected to the oxygenation channel. One end of the oxygenation channel is connected to the temperature variable module (3), and the other end is connected to the arterial connecting pipe (6).

8. The integrated cardiopulmonary assist device according to claim 7, characterized in that: The gas supply pipe (9) is provided with an air inlet (13) at one end and an air outlet (14) at the other end; the position where the gas supply pipe (9) is connected to the temperature variable module (3) is arranged close to the air inlet (13), and the position where the gas supply pipe (9) is connected to the arterial connecting pipe (6) is arranged close to the air outlet (14).

9. The integrated cardiopulmonary assist device according to claim 8, characterized in that: A plurality of hollow fibers connected to the air inlet (13) are arranged in the oxygenation channel.

10. The integrated cardiopulmonary assist device according to claim 1, characterized in that: The pulsating element is an air bag (10).

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