An external aortic counterpulsation device with an extracorporeal breathing chamber

Abstract

The present invention discloses an aortic external counterpulsation device with an extracorporeal breathing chamber, comprising an intracorporeal catheter and a breathing chamber assembly, wherein the breathing chamber assembly is also connected to a counterpulsation controller via a wire. A plurality of through holes are provided on the inner end side wall of the intracorporeal catheter, and the outer end of the intracorporeal catheter is closedly connected to an extracorporeal balloon; the breathing chamber assembly comprises a shell, a piston driving mechanism and an elastic breathing chamber membrane arranged inside the shell, wherein the closed end of the elastic breathing chamber membrane is connected to the piston, and the open end of the elastic breathing chamber membrane is sealedly connected to the outer side of the root of the extracorporeal balloon after wrapping the extracorporeal balloon. The piston driving mechanism drives the elastic breathing chamber membrane to expand or compress, thereby causing the extracorporeal balloon to expand or be compressed, thereby realizing blood flow. The present invention realizes extracorporeal counterpulsation of blood in the descending aorta by placing the balloon externally and relying on the extracorporeal breathing chamber assembly to expand and compress the extracorporeal balloon. This structure can greatly increase the volume of the extracorporeal balloon, ultimately increasing cardiac output and meeting the patient's systemic blood supply needs.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to an external aortic counterpulsation device with an extracorporeal breathing chamber. Background Art

[0002] The intra-aortic balloon pump (IABP) is a mechanical device designed to assist the failing left ventricle based on the principle of counterpulsation. It is commonly used for interventional cardiac surgery, in-hospital rehabilitation after a heart attack, or other major cardiac event. It is the most commonly used assistive device during the perioperative period of PCI and is particularly well-suited for providing advanced life support to critically ill cardiac patients, effectively improving coronary blood flow and alleviating low cardiac output and blood pressure. The basic principle of the IABP is that a balloon placed in the descending aorta is inflated during diastole and deflated during systole to provide cardiac support. Inflation of the balloon during diastole increases diastolic pressure, increasing coronary blood flow, improving myocardial blood and oxygen delivery, and also increasing perfusion to the brain, kidneys, and peripheral blood. Rapid degassing of the balloon during systole creates a "cavitation effect," reducing left ventricular afterload and lowering myocardial oxygen demand.

[0003] In the treatment of cardiovascular disease, the IABP is the most commonly used assistive device during the PCI period. According to data from the US National Cardiovascular Data Registry from 2009 to 2013, 89.3% of patients using pMCS support used an IABP, while other assistive devices accounted for only 10.7%. Currently, all intra-aortic balloon pumps (IABPs) in China are imported. Major global manufacturers include Getinge Group, Teleflex, and Senko Medical Instrument Mfg. Co., Ltd. (MERA). In 2020, Getinge accounted for over 80% of the market share. The selection criteria for IABP balloons are based on height. Currently, Teleflex's Arrow IABP system catheters have diameters of 7 fr, 7.5 fr, and 8 fr, and balloon capacities of 30 cc, 40 cc, and 50 cc.

[0004] A comparison of the use of IABP, ECOM, and artificial hearts reveals that the IABP offers significant advantages in terms of sheath size, bedside insertion, operational difficulty, indwelling time, postoperative management requirements, and risk of hemolysis. Its only drawback is its low cardiac output, which is only 0.5 to 1 L per minute. Consequently, its actual patient outcomes are significantly inferior to those of ECOM and artificial hearts. Given this significant limitation of the IABP, international and domestic physicians and engineers have attempted numerous approaches, all with limited success. Consequently, no effective solution has yet been found to address the low cardiac output of IABP devices.

[0005] Based on this, the present application fully utilizes the advantages of the IABP device and creatively proposes an extra-aortic counterpulsation device with an extracorporeal breathing chamber. By adopting the extra-aortic counterpulsation method, a balloon-like device is placed outside the body, so that it can maximize cardiac output and compensate for the problem of too low cardiac output of the IABP device. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide an extra-aortic counterpulsation device with an extracorporeal breathing chamber, so as to maximize the cardiac output and compensate for the problem of too low cardiac output of the IABP device.

[0007] To solve the above technical problems, the present invention provides an external aortic counterpulsation device with an external breathing chamber, comprising an internal catheter for extending into the descending aorta and a breathing chamber assembly disposed externally, wherein one end of the breathing chamber assembly is connected to the external end of the internal catheter, and the other end is used to connect to a counterpulsation controller;

[0008] The inner end side wall of the intracorporeal catheter is provided with a plurality of through holes, and the outer end of the intracorporeal catheter is closedly connected to an extracorporeal balloon;

[0009] The breathing chamber assembly includes a shell and a piston drive mechanism and an elastic breathing chamber membrane arranged inside the shell. The closed end of the elastic breathing chamber membrane is fixedly connected to the piston of the piston drive mechanism. The open end of the elastic breathing chamber membrane wraps the extracorporeal balloon and is sealed to the outside of the root of the extracorporeal balloon. A breathing chamber is formed between the elastic breathing chamber membrane and the extracorporeal balloon. The piston drive mechanism drives the elastic breathing chamber membrane to expand or compress. When the elastic breathing chamber membrane is expanded, a vacuum is formed inside the breathing chamber, prompting the extracorporeal balloon to be blown up in the opposite direction, which is used to draw blood in the descending aorta into the extracorporeal balloon. When the elastic breathing chamber membrane is compressed, the internal space of the breathing chamber is squeezed, prompting the blood in the extracorporeal balloon to be perfused back into the body, thereby realizing the extra-aortic blood counterpulsation effect.

[0010] As a further improvement, the diameter of the lumen of the intracorporeal catheter is 2.2 to 9 mm, the length of the opening section of the intracorporeal catheter is 320 to 520 mm, the diameter of the through hole is 1 to 4 mm, and the spacing between two adjacent through holes is 1 to 10 mm.

[0011] As a further improvement, the interior of the intracorporeal catheter is further provided with a diaphragm for dividing the interior of the catheter into a blood extraction cavity and a perfusion cavity, one end of the diaphragm is located at the starting point of the opening of the intracorporeal catheter, and the other end of the diaphragm is located at the root of the extracorporeal balloon.

[0012] As a further improvement, both sides of the diaphragm are respectively bonded to the inner side wall of the in-vivo catheter, and both ends of the diaphragm are tilted so that the inner end of the blood drawing cavity and the outer end of the perfusion cavity are in a trumpet-shaped structure.

[0013] As a further improvement, the diaphragm is an elastic film.

[0014] As a further improvement, the in vivo catheter is made of PTFE, PU, ​​Pebax or PE polymer materials and is prepared by blow molding or extrusion process. The in vitro balloon and elastic breathing chamber membrane are both made of elastic silicone rubber or polyurethane materials. The film is made of elastic silicone rubber, polyurethane, PTFE, PU, ​​Pebax or PE medical polymer materials, and the thickness of the film is 0.5 to 1.5 mm.

[0015] As a further improvement, both ends of the diaphragm are provided with a one-way valve, the one-way valve includes a valve plate and a rotating shaft, the rotating shaft is fixed to the end of the diaphragm, one end of the valve plate is rotatably connected to the rotating shaft, and the other end matches the inner wall structure of the in vivo catheter, and the end of the valve plate connected to the rotating shaft is also provided with a limit block for limiting the rotation angle of the valve plate. The valve plates at both ends of the diaphragm are arranged in opposite directions for alternately realizing the opening and closing of the blood drawing chamber and the perfusion chamber.

[0016] As a further improvement, the valve plate is made of hard polymer material, metal material or ceramic material.

[0017] As a further improvement, a pressure sensor is provided on the outside of the inner end of the intracorporeal catheter.

[0018] As a further improvement, the counterpulsation controller adopts the controller of the IABP system to provide electrical energy and control signals to the breathing chamber component.

[0019] After adopting such a design, the present invention has at least the following advantages:

[0020] 1. The extra-aortic counterpulsation device of the present invention is provided with an extracorporeal balloon on the outer end side of the in-vivo catheter, and a plurality of through holes on the inner end side. When in use, the in-vivo catheter and the blood vessel form a closed space, and the extracorporeal balloon is expanded and compressed by the extracorporeal breathing chamber assembly to achieve extracorporeal counterpulsation of the blood in the descending aorta. This structure can greatly increase the volume of the extracorporeal balloon, and the maximum volume can reach 200ML, and ultimately the cardiac output can reach more than 5L / min, thereby meeting the patient's systemic blood supply needs and greatly improving the patient's blood supply status. This structure keeps the breathing chamber away from the aortic blood vessel, and even in the event of high-risk events such as breathing chamber leakage, it can be blocked in time to prevent adverse effects on the patient, and has high safety.

[0021] 2. The diaphragm in the catheter is provided to form a dual-channel structure, one side of which is used to aspirate blood and the other side is used to perfuse blood. The two cavities do not affect each other, thus avoiding the problems of blood collision and severe turbulence in a single channel.

[0022] 3. By setting up the elastic film and setting the two ends of the elastic film into a trumpet-shaped structure, the one-way flow of blood can be effectively guaranteed, and the one-way cross-section of blood can be maximized during the suction and perfusion process, thereby greatly reducing external power and better realizing the one-way flow of blood.

[0023] 4. The setting of the one-way valve at the end of the diaphragm can better ensure the one-way flow of the blood drawing cavity and the perfusion cavity, greatly reducing the external power and being more conducive to blood flow.

[0024] 5. The external aortic counterpulsation device of the present invention also adopts a motor drive, eliminating the various defects of air pump drive, such as air leakage, gas compression, and unclean gas. At the same time, it can provide greater power and provide a more favorable guarantee for a larger cardiac output. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The above is only an overview of the technical solution of the present invention. In order to more clearly understand the technical means of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0026] Figure 1 It is a schematic structural diagram of the external aortic counterpulsation device of the present invention applied to a human body.

[0027] Figure 2 It is a schematic structural diagram of the in-vivo catheter in the extra-aortic counterpulsation device of the present invention.

[0028] Figure 3 It is a structural schematic diagram of the breathing chamber assembly in the extra-aortic counterpulsation device of the present invention (extracorporeal balloon expanded state).

[0029] Figure 4It is a structural schematic diagram of the breathing chamber assembly in the extra-aortic counterpulsation device of the present invention (extracorporeal balloon compressed state).

[0030] Figure 5 It is a structural schematic diagram of the in-vivo catheter diaphragm setting section in the extra-aortic counterpulsation device of the present invention.

[0031] Figure 6 It is a cross-sectional schematic diagram of the diaphragm setting section of the in-vivo catheter in the extra-aortic counterpulsation device of the present invention (in the expanded state of the blood extraction cavity).

[0032] Figure 7 It is a cross-sectional schematic diagram of the diaphragm setting section of the in-vivo catheter in the extra-aortic counterpulsation device of the present invention (in the expanded state of the perfusion cavity).

[0033] Figure 8 The figure is a schematic diagram of the structure of a one-way valve provided at the end of the diaphragm in the external aortic counterpulsation device of the present invention.

[0034] Figure 9 It is a structural schematic diagram of the open state of a one-way valve on one side of the external aortic counterpulsation device of the present invention.

[0035] Figure 10 It is a structural schematic diagram of the closed state of a one-way valve on one side of the external aortic counterpulsation device of the present invention. DETAILED DESCRIPTION

[0036] Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0037] It should also be noted that the directions or positional relationships indicated by "left", "right", "inside" and "outside" in this application are based on the directions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction. Therefore, it should not be understood as a limitation on the present invention.

[0038] Refer to the attached Figure 1 As shown, this embodiment of an extra-aortic counterpulsation device with an external breathing chamber includes an internal catheter 1 and a breathing chamber assembly 2. One end of the internal catheter 1 is configured to extend into the descending aorta 10 within the body. The breathing chamber assembly 2 is disposed externally, with one end connected to the external end of the internal catheter 1 and the other end connected to a counterpulsation controller 4 via a wire 3.

[0039] Refer to the attached Figure 2As shown, the inner sidewall of the intracorporeal catheter 1 is provided with a plurality of through-holes 11, and the outer end of the intracorporeal catheter 1 is sealedly connected to an extracorporeal balloon 12. When the intracorporeal catheter 1 enters the body, it forms a closed space with the blood vessels in the body, and blood flows through the formed passage.

[0040] Specifically, the overall length of the intracorporeal catheter 1 is 500 to 1000 mm, and can preferably be configured in sizes of 600, 750, or 900 mm to accommodate individuals of varying heights. The outer diameter of the intracorporeal catheter 1 ranges from a minimum of 7 French (F) to a maximum of 24 French (F), meaning its lumen diameter is 2.2 to 9 mm. This diameter is determined by the fact that the lumen diameter of the human aorta is generally around 10 mm, so the outer diameter of the catheter must be smaller than the inner diameter of the vessel while maintaining a certain clearance. A clearance of 0.5 mm on each side is essential, so the maximum outer diameter of the catheter cannot exceed 9 mm, otherwise it will damage the inner wall of the vessel. Of course, the catheter cannot be too thin. If it is too thin, both blood extraction and infusion will be extremely laborious, the load will be very heavy, and the hysteresis effect of the liquid will become very significant. Furthermore, during vigorous suctioning, a vacuum will be created, which can damage blood cells and may also cause air embolism, endangering the patient's life.

[0041] Furthermore, the length of the opening section of the intracorporeal catheter 1, where the through-holes 11 are provided, is 320 to 520 mm. Multiple through-holes 11 are provided to reduce the load during blood withdrawal and perfusion, thereby facilitating blood flow. The diameter of the through-holes 11 is 1 to 4 mm and is evenly distributed around the catheter wall. The distribution pattern is not limited and can be spiral or evenly spaced in a circle. The optimal arrangement is to ensure that the spacing between any two holes is equal, within a range of 1 to 10 mm. Too small a spacing will compromise the overall rigidity of the catheter, while too large a spacing will increase the suction load. The same principle applies to the aperture size: too small an aperture will increase the suction load and make it more difficult, while too large an aperture will compromise the overall rigidity and make the catheter susceptible to damage. Note: The starting point of the aperture in the catheter wall should not be too close to the puncture site, as this can easily lead to bleeding. The optimal distance L between the starting section of the aperture and the puncture site is 20 to 80 mm. If the distance is too short, excessive pressure during blood aspiration and perfusion may cause bleeding. If the distance is too long, the unperforated blind cavity area will be large, increasing the aspiration load and making aspiration more difficult. The optimal L range is 30-50 mm.

[0042] In this embodiment, a pressure sensor 5 is provided on the outer side of the inner end of the intracorporeal catheter 1 for real-time monitoring of blood pressure and transmitting the signal to the counterpulsation controller 4 to form a controlled trigger mode.

[0043] The application principle of the extra-aortic counterpulsation device is as follows: through a puncture operation, the intracorporeal catheter 1 is placed into the aorta, and its end position is the descending aorta 10, reaching the aortic arch at most, but not entering the aortic arch, preferably about 100 mm away from the bend of the aortic arch. The location of the surgical puncture can be the femoral artery, the radial artery, or the carotid artery. After the puncture of the intracorporeal catheter 1 is completed, the blood in the intracorporeal descending aorta 10 is led out along the catheter into the extracorporeal balloon 12 through the through hole 11 under the control of the respiratory chamber assembly 2 and the counterpulsation controller 4, and then perfused and pressed back into the intracorporeal descending aorta 10 to achieve extra-aortic blood counterpulsation.

[0044] Refer to the attached Figure 3 and 4 As shown, the breathing chamber assembly 2 in this embodiment includes a housing 21, a piston drive mechanism 22, and an elastic breathing chamber membrane 23 disposed within the housing 21. The housing 21 houses the other components of the breathing chamber assembly 2 and provides a rigid environment, allowing all work to occur internally without impacting the external environment. The housing 21 can be configured as a backpack or shoulder bag for easy portability during patient activities.

[0045] The piston drive mechanism 22 includes a piston 221 and a driver 222 that drives the piston 221 to achieve extension and retraction. The driver 222 can be a combination of a motor and a crank slider, a motor and a linear bearing, a linear motor, or a voice coil motor. In order to be able to draw 200 ml of blood into the extracorporeal balloon 12 and smoothly infuse it back, a motor with a thrust of 100 kg is selected. The housing 21 can be pre-evacuated or filled with a safe gas such as helium, air, or nitrogen, or a safe liquid such as physiological saline, water for injection, or purified water. In addition, when the driver is working, a certain amount of noise may be generated, so a silencer can also be provided in the housing 21.

[0046] The closed end of the elastic breathing chamber membrane 23 is fixedly connected to the piston 221 of the piston drive mechanism 22. After the open end of the elastic breathing chamber membrane 23 wraps the extracorporeal balloon 12, it is sealed and connected to the outside of the root of the extracorporeal balloon 12, such as by bonding or threading. A breathing chamber 24 is formed between the elastic breathing chamber membrane 23 and the extracorporeal balloon 12. The elastic breathing chamber membrane 23 is a curved elastic membrane that can achieve the effects of stretching and folding. The material can be made of highly elastic materials such as silicone rubber and polyurethane. In this way, the extracorporeal balloon 12, driven by the piston drive mechanism 22, drives the elastic breathing chamber membrane 23 to achieve the reciprocating action of expansion and compression. When the elastic breathing chamber membrane 23 is expanded, a vacuum is formed inside the breathing chamber 24, causing the extracorporeal balloon 12 to be blown up in the reverse direction, so as to draw blood in the descending aorta into the extracorporeal balloon 12, such as Figure 3When the elastic breathing chamber membrane 23 is compressed, the internal space of the breathing chamber 24 is squeezed, prompting the blood in the extracorporeal balloon 12 to be perfused back into the body, as shown Figure 4 As shown, extra-aortic blood counterpulsation flow is achieved.

[0047] A preferred embodiment is as follows: Figure 5 As shown, the interior of the intracorporeal catheter 1 is further provided with a diaphragm 15 for dividing the interior of the catheter into a blood extraction cavity 13 and a perfusion cavity 14 , one end of the diaphragm 15 is located at the opening of the intracorporeal catheter 1 , and the other end of the diaphragm 15 is located at the root of the extracorporeal balloon 12 .

[0048] Specifically, both sides of the diaphragm 15 are respectively bonded to the inner wall of the in-vivo catheter 1, and both ends of the diaphragm 15 are tilted so that the inner end of the blood extraction cavity 13 and the outer end of the perfusion cavity 14 are in a trumpet-shaped structure. Figure 5 As shown, it is used to guide the flow of blood in the catheter in the body, thereby ensuring smooth blood inflow and outflow.

[0049] Preferably, the diaphragm 15 is made of an elastic film. The film is made of elastic silicone rubber, polyurethane, PTFE, PU, ​​Pebax or PE medical polymer material. When blood is drawn, the elastic film deforms to the left, that is, it is squeezed toward the perfusion chamber 14, thereby making the blood drawing chamber 13 larger and the perfusion chamber 14 smaller. Figure 6 During the perfusion process, the film deforms to the right, that is, it squeezes toward the blood extraction chamber 13, thereby making the perfusion chamber 14 larger and the blood extraction chamber 13 smaller, as shown in the attached figure. Figure 7As shown. Thus, the adaptive adjustment function is realized during the suction and perfusion process. In the initial state, the film is centered, dividing the lumen of the catheter into two halves, that is, the cross-sectional area of ​​the blood drawing cavity 13 and the perfusion cavity 14 is the same. The reason for designing a dual-lumen structure is that if a single-channel catheter is used, during the process of blood being sucked and perfused, the blood in the lumen will always be in a reciprocating process of acceleration → deceleration → stop → reverse acceleration → reverse deceleration → stop. In this process, due to the high frequency and fast speed, the liquid cannot quickly feedback, and a vacuum phenomenon will naturally occur. The liquids collide with each other and the turbulence is severe. However, if it is set as a dual-channel, the blood is sucked in from one end and perfused back from the other end, and there is no mutual influence. Then the corresponding speed will also be accelerated, the vacuum and turbulence phenomena will disappear, and the required external power will be greatly reduced. Therefore, the catheter with a dual-lumen structure of the present application can ensure the unidirectional flow of blood. Furthermore, if only an inelastic membrane were used to divide the lumen into two, the cross-section of each lumen would become very small, less than or equal to half of the original cross-section, which would increase the difficulty of aspiration and perfusion. Therefore, the present invention has created an innovative elastic membrane with a trumpet-shaped structure at both ends, which can effectively ensure the unidirectional flow of blood and maximize the cross-section during each process, thereby greatly reducing external forces and achieving unidirectional blood flow.

[0050] More specifically, the intracorporeal catheter 1 is made of PTFE, PU, ​​Pebax or PE polymer material and is prepared by blow molding or extrusion process, and the extracorporeal balloon 12 and the elastic breathing chamber membrane 23 are both made of silicone rubber or polyurethane material.

[0051] Better, refer to the attached Figure 8 、 9 As shown in Figures 10 and 10, both ends of the diaphragm 15 in this embodiment are provided with one-way valves to ensure the one-way flow of blood. The one-way valve includes a valve plate 16 and a rotating shaft 17. The rotating shaft 17 is fixed to the end of the diaphragm 15. One end of the valve plate 16 is rotatably connected to the rotating shaft 17, and the other end matches the inner wall structure of the in-vivo catheter 1. The end of the valve plate 16 connected to the rotating shaft 17 is also provided with a limit block 18 for limiting the rotation angle of the valve plate 16. The limit block 18 can enable the valve plate 16 to rotate within the range of 0 to 90°, not exceeding 90°, to achieve the opening and closing of the valve plate 16. That is, the limit block 18 can enable the valve plate 16 to only open and close the perfusion chamber 14 or the blood extraction chamber 13.

[0052] The valve plates 16 at both ends of the diaphragm 15 are arranged in opposite directions to alternately open and close the blood extraction chamber 13 and the perfusion chamber 14. For example, when the breathing chamber 24 is expanded, the balloon 12 of the intracorporeal catheter 1 will expand, at which point the one-way valve on the outer end opens and the one-way valve on the inner end closes, closing the perfusion chamber 14 and thereby drawing blood from the body into the balloon 12. When the breathing chamber 24 is collapsed, the balloon 12 of the intracorporeal catheter 1 is compressed, at which point the one-way valve on the inner end opens and the one-way valve on the outer end closes, closing the blood extraction chamber and thereby perfusing blood from the balloon 12 into the body.

[0053] Specifically, the valve disc 16 is made of hard polymer materials, metal materials or ceramic materials, such as PEEK, PPSU, UHMWPE and the like as polymer materials, 316L stainless steel, cobalt-chromium-molybdenum alloy, titanium alloy and the like as metal materials, and zirconia ceramics, alumina ceramics, zirconia-toughened alumina ceramics and the like as ceramic materials. The valve disc 16 and the rotating shaft 17 can be integrated or separated. When integrated, because the film 15 has a certain elasticity, the opening and closing of the valve disc 16 can be achieved by relying on the elastic deformation of the film 15. However, such a form may make the film 15 susceptible to fatigue damage, so the thickness of the film 15 should be thicker, ranging from 0.5 to 1.5 mm, and the toughness should also be stronger. Silicone rubber or polyurethane materials are more suitable. When the rotating shaft 17 and the valve plate 16 are separated, a friction pair is formed between the valve plate 16 and the rotating shaft 17, so wear and debris will be generated between them. In order to minimize friction and wear, ceramic valve plates and ceramic rotating shafts are more suitable, such as zirconia ceramics, alumina ceramics, zirconia-toughened alumina ceramics, etc.

[0054] In this embodiment, the wire 3 is used to connect the breathing chamber assembly 2 and the counterpulsation controller 4 to provide power and control signals to the breathing chamber assembly 2, so that the counterpulsation controller 4 controls the driver to perform corresponding movements.

[0055] In this embodiment, the counterpulsation controller 4 utilizes the controller of the IABP system, providing power and control signals to the respiratory chamber assembly. The counterpulsation controller 4 has the following functions: 1) Waveform display: ECG, AP, and BP waveforms; adjustable ECG piston action interval; accurate display of catheter pressure; 2) Physiological data display: heart rate, assisted systolic / diastolic / mean / counterpulsation pressure, and unassisted systolic / diastolic / mean pressure; 3) Icon display: battery capacity, piston status; and display of respiratory chamber pressure values; 4) Control methods include: single touchscreen control; keypad control; alarm angle control; and dual control of key / common functions: touchscreen / keypad control: auxiliary start, auxiliary frequency, screen freeze, print, and reference line setting. 5) Operating modes include automatic and manual; the working mode switching process does not affect normal counterpulsation; when the working mode is switched, the device automatically retains the original settings; Automatic mode: automatically selects the signal source; automatically selects the trigger mode (6 types); automatically selects the phase algorithm; evaluates the ECG lead status in real time; automatically selects the best ECG lead (7 types); Manual mode: can select the signal source; select the trigger mode; adjust the phase; select the ECG lead. 6) 7 trigger modes: Pattern mode, Peak mode, Aifb mode, pacemaker V / AV mode, pacemaker A mode, AP mode, in-machine setting mode; 7) Balloon delay analysis: real-time calculation of balloon perfusion rate and evaluation of R-wave exhaust safety; 8) 4 auxiliary frequencies: 1:1 / 1:2 / 1:4 / 1:8; 9) Counterpulsation frequency: up to 200 times / minute; 10) Counterpulsation volume: 0-150ml / time, precisely adjustable with an adjustment accuracy of 0.5ml; 11) Automatic water removal (the driver generates heat when working and needs to be cooled, which will produce condensed water. Therefore, the condensed water needs to be removed when the device is in use, once every 20 minutes, automatically completed without affecting normal assistance; 12) Patient data report: can display and print all patient information related to counterpulsation; 13) Power-on self-test list: checklist prompt function self-test results; 14) Alarm history record: can display and print the latest 100 alarms.

[0056] Of course, the counterpulsation controller 4 may also adopt other structures as long as it can achieve functions similar to those of the IABP system controller.

[0057] The inventors of this invention named the external aortic counterpulsation device with an external breathing chamber OABP. Its principle differs from that of the IABP in that it no longer uses any gas as a power source, but instead directly drives fluid movement. Furthermore, the OABP's actuation process occurs outside the body, making it more controllable and safer. This device places the balloon outside the body, rather than inside the body as with the IABP. This is because the length and diameter of the human aorta are limited. IABP devices only offer three sizes, 30cc, 40cc, and 50cc, resulting in a maximum cardiac output of no more than 1 L / min. By placing the balloon outside the body, the enclosed space formed by the internal catheter 1 simulates the aorta, or in other words, an extension of the human aorta. When the internal catheter 1 is outside the body, its size, shape, and volume can be designed based on the maximum cardiac output. For example, a 200ml external balloon can achieve a cardiac output of 5 to 10 L / min, completely resolving the significant drawback of the IABP's insufficient cardiac output while retaining all the advantages of the IABP.

[0058] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Those skilled in the art can make some simple modifications, equivalent changes or modifications based on the technical content disclosed above, which all fall within the scope of protection of the present invention.

Claims

1. An external aortic counterpulsation device with an extracorporeal breathing chamber, characterized in that: It comprises an in-vivo catheter for extending into the descending aorta and a breathing chamber component arranged outside the body, wherein one end of the breathing chamber component is connected to the outer end of the in-vivo catheter, and the other end is used to connect to a counterpulsation controller; The inner end side wall of the in-vivo catheter is provided with a plurality of through holes, and the outer end of the in-vivo catheter is closedly connected to an in-vitro balloon; The breathing chamber assembly includes a shell, a piston drive mechanism and an elastic breathing chamber membrane arranged inside the shell, the closed end of the elastic breathing chamber membrane is fixedly connected to the piston of the piston drive mechanism, the open end of the elastic breathing chamber membrane is sealed and connected to the outside of the root of the extracorporeal balloon after wrapping the extracorporeal balloon, and a breathing chamber is formed between the elastic breathing chamber membrane and the extracorporeal balloon, the piston drive mechanism drives the elastic breathing chamber membrane to expand or compress, when the elastic breathing chamber membrane is expanded, a vacuum is formed inside the breathing chamber, prompting the extracorporeal balloon to be blown up in the reverse direction, so as to draw blood in the descending aorta into the extracorporeal balloon, when the elastic breathing chamber membrane is compressed, the internal space of the breathing chamber is squeezed, prompting the blood in the extracorporeal balloon to be perfused back into the body, so as to achieve the effect of extra-aortic blood counterpulsation; The interior of the in-vivo catheter is also provided with a diaphragm for dividing the interior of the catheter into a blood extraction cavity and a perfusion cavity, one end of the diaphragm is located at the start of the opening of the in-vivo catheter, and the other end of the diaphragm is located at the root of the in-vivo balloon; Both sides of the diaphragm are respectively bonded to the inner side wall of the in-vivo catheter, and both ends of the diaphragm are arranged obliquely, so that the inner end of the blood drawing cavity and the outer end of the perfusion cavity are in a trumpet-mouth structure.

2. The extra-aortic counterpulsation device with an extracorporeal breathing chamber according to claim 1, characterized in that: The diameter of the lumen of the in vivo catheter is 2.2-9 mm, the length of the opening section of the in vivo catheter is 320-520 mm, the diameter of the through hole is 1-4 mm, and the spacing between two adjacent through holes is 1-10 mm.

3. The extra-aortic counterpulsation device with an extracorporeal breathing chamber according to claim 1, characterized in that: The diaphragm is an elastic film.

4. The extra-aortic counterpulsation device with an extracorporeal breathing chamber according to claim 3, characterized in that: The in vivo catheter is made of PTFE, PU, ​​Pebax or PE polymer material and is prepared by blow molding or extrusion process. The in vitro balloon and elastic breathing chamber membrane are both made of elastic silicone rubber or polyurethane material. The film is made of elastic silicone rubber, polyurethane, PTFE, PU, ​​Pebax or PE medical polymer material, and the thickness of the film is 0.5 to 1.5 mm.

5. The extra-aortic counterpulsation device with an extracorporeal breathing chamber according to claim 1, characterized in that: Both ends of the diaphragm are provided with a one-way valve, and the one-way valve includes a valve plate and a rotating shaft. The rotating shaft is fixed to the end of the diaphragm, one end of the valve plate is rotatably connected to the rotating shaft, and the other end matches the inner wall structure of the in vivo catheter, and the end of the valve plate connected to the rotating shaft is also provided with a limit block for limiting the rotation angle of the valve plate. The valve plates at both ends of the diaphragm are oppositely arranged for alternately realizing the opening and closing of the blood drawing cavity and the perfusion cavity.

6. The extra-aortic counterpulsation device with an extracorporeal breathing chamber according to claim 5, characterized in that: The valve plate is made of hard polymer material, metal material or ceramic material.

7. The extra-aortic counterpulsation device with an extracorporeal breathing chamber according to any one of claims 1 to 6, characterized in that: A pressure sensor is arranged outside the inner end of the in-vivo catheter.

8. The extra-aortic counterpulsation device with an extracorporeal breathing chamber according to claim 1, characterized in that: The counterpulsation controller adopts the controller of the IABP system to provide electrical energy and control signals to the breathing chamber component.

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