A multi-balloon external aortic counterpulsation device

Abstract

The present invention discloses a multi-balloon external aortic counterpulsation device, comprising an in-vivo catheter, a sac cavity and an IABP balloon arranged inside the sac cavity, one end of the IABP balloon is extended out of the sac cavity and is used to connect with a controller. A plurality of through holes are arranged on the side wall of the inner end of the in-vivo catheter, and the outer end of the in-vivo catheter is sealed and connected with the first interface of the sac cavity; the sac cavity comprises a plurality of IABP balloons arranged in parallel, each IABP balloon extends out of the sac cavity through a sealing valve, and the plurality of IABP balloons simultaneously realize inflation and deflation actions, and when the plurality of IABP balloons are simultaneously deflated, blood is sucked into the sac cavity, and when the plurality of IABP balloons are simultaneously inflated, the blood inside the sac cavity is pushed back into the body to realize blood flow. The present invention utilizes the inflation and deflation actions of the external balloon to realize the squeezing and suction of the blood inside the sac cavity, and utilizes the in-vitro sac cavity to accommodate more balloons, thereby achieving the technical effect of doubling the 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, and in particular to a multi-balloon external aortic counterpulsation device. Background Art

[0002] Intra-aortic balloon pump (IABP) is a mechanical device designed according to the principle of counterpulsation to assist the failing left heart. It is usually used for in-hospital rehabilitation after interventional cardiac surgery, heart attack or other major cardiac events. It is the most commonly used auxiliary device during the PCI perioperative period. It is particularly suitable for providing advanced life support for patients with critical heart disease. It can effectively improve the patient's coronary blood supply and improve the patient's low cardiac output and low blood pressure. The basic principle of IABP is to use a balloon placed in the descending aorta to inflate during the diastole of the heart and exhaust during the systole to achieve the effect of assisting the heart circulation. Inflation of the aortic balloon during diastole can increase diastolic pressure, increase coronary blood flow, improve myocardial blood supply and oxygen supply, and also increase blood perfusion of the brain, kidneys and periphery; rapid resuscitation and emptying of the balloon during systole can produce a "cavitation effect", reduce the afterload of the left ventricle, and reduce myocardial oxygen consumption.

[0003] In the treatment of cardiovascular diseases, IABP is the most commonly used auxiliary device during the PCI perioperative period. According to the data of the National Cardiovascular Data Registry of the United States from 2009 to 2013, among patients using pMCS support, 89.3% used IABP, and other auxiliary devices accounted for only 10.7%. At present, all domestic intra-aortic balloon pumps (IABP) are imported. The world's major manufacturers include Getinge Group, Teleflex and Senko Medical lnstrument Mfg. Co., Ltd (MERA). Among them, Getinge's share accounted for more than 80% in 2020. The selection criteria of IABP balloons are determined by height to determine the size of the balloon. At present, the diameters of the IABP system catheters of Arrow under Teleflex are 7fr, 7.5fr, and 8fr, and the balloon capacities include three sizes of 30cc, 40cc and 50cc.

[0004] Comparing the use of IABP, ECOM, and artificial heart, IABP has absolute advantages in sheath size, bedside placement, operation difficulty, retention time, postoperative management requirements, and hemolysis risk. The only drawback is that the cardiac output is too low, with a cardiac output of only 0.5 to 1L per minute. Therefore, in terms of actual use effect of patients, it is significantly inferior to ECOM and artificial heart. In view of this major drawback of IABP equipment, doctors and engineers have tried many methods, but with little success. Therefore, there is still no effective way to solve the problem of low cardiac output of IABP equipment.

[0005] On this basis, the present application fully utilizes the advantages of the IABP device and creatively proposes a multi-balloon extra-aortic counterpulsation device, which adopts the extra-aortic counterpulsation method and places the balloon outside the body to maximize the 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 a multi-balloon extra-aortic counterpulsation device, which can maximize the cardiac output and make up for the problem of too low cardiac output of IABP equipment.

[0007] In order to solve the above technical problems, the present invention provides a multi-balloon external aortic counterpulsation device, comprising an in-vivo catheter for extending into the descending aorta and a balloon cavity connected to the external end of the in-vivo catheter, and an IABP balloon arranged inside the balloon cavity, one end of the IABP balloon extending out of the balloon cavity is used to be connected to a controller, and the balloon is inflated and deflated under the control of the controller;

[0008] A plurality of through holes are provided on the inner end side wall of the in-vivo catheter, and the outer end of the in-vivo catheter is sealedly connected to the first interface of the cystic cavity, so that the in-vivo catheter is communicated with the inside of the cystic cavity;

[0009] The balloon cavity includes a plurality of IABP balloons arranged in parallel, each of which extends out of the balloon cavity through a sealing valve, and the plurality of IABP balloons are inflated and deflated simultaneously. When the plurality of IABP balloons are deflated simultaneously, the space occupied by the balloons in the balloon cavity is reduced, and the blood in the descending aorta is sucked into the balloon cavity. When the plurality of IABP balloons are inflated simultaneously, the space occupied by the balloons in the balloon cavity is enlarged, and the blood inside the balloon cavity is pushed back into the body, thereby realizing the extra-aortic blood counterpulsation effect.

[0010] As a further improvement, the balloon cavity includes 2-10 IABP balloons.

[0011] As a further improvement, the first interface of the sac cavity and the outer end interface of the in vivo catheter adopt mutually matching Luer connectors.

[0012] As a further improvement, a pressure sensor is provided on the outside of the inner end of the intracorporeal catheter.

[0013] As a further improvement, 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.

[0014] As a further improvement, the interior of the intracorporeal catheter is also provided with a diaphragm for dividing the interior of the catheter into a blood drawing chamber and a perfusion chamber, one end of the diaphragm is located at the beginning of the opening of the intracorporeal catheter, and the other end of the diaphragm is located at the extracorporeal end of the intracorporeal catheter.

[0015] As a further improvement, both sides of the diaphragm are respectively bonded to the inner wall of the in-vivo catheter, and both ends of the diaphragm are inclined so that the inner end of the blood drawing cavity and the outer end of the perfusion cavity present a trumpet-mouth structure.

[0016] As a further improvement, the diaphragm is an elastic film.

[0017] Further improvement, the in vivo catheter is made of PTFE, PU, ​​Pebax or PE polymer material and is prepared by a blow molding or extrusion process, the sac cavity is made of silicone rubber, polyurethane, PTFE, PU, ​​Pebax or PE polymer material with a hardness of more than 65 degrees and is prepared by an injection molding or blow molding process, and the film is made of silicone rubber, polyurethane, PTFE, PU, ​​Pebax or PE medical polymer material with elasticity and a hardness of less than 30 degrees.

[0018] As a further improvement, the controller adopts the controller of the IABP system to provide inflation and deflation gas for the IABP balloon.

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

[0020] 1. The multi-balloon aortic counterpulsation device of the present invention realizes the squeezing and suction of the blood inside the balloon cavity by placing the IABP balloon outside and utilizing the inflation and deflation action in the extracorporeal balloon cavity, thereby realizing the extracorporeal counterpulsation of the blood in the descending aorta. The multi-balloon aortic counterpulsation device can accommodate more balloons by utilizing the extracorporeal balloon cavity, and multiple balloons can be operated simultaneously, thereby achieving the technical effect of doubling the cardiac output, and truly overcoming the problem of low cardiac output caused by only one balloon inflation and deflation action when the balloon is built-in. Moreover, the device can completely use the existing IABP equipment and IABP balloons, has 100% compatibility, low cost, good effect, and can make the cardiac output reach more than 5L / min, meet the patient's systemic blood supply needs, and greatly improve the patient's blood supply status. In addition, the device keeps the balloon away from the aortic blood vessels, and even if high-risk events such as balloon leakage occur, it can be blocked in time to prevent adverse effects on the patient.

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

[0022] 3. By setting the elastic film and setting the two ends of the elastic film into a trumpet 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] 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 implementation methods.

[0024] Figure 1 It is a schematic structural diagram of the multi-balloon extra-aortic counterpulsation device of the present invention applied to a human body.

[0025] Figure 2 It is a schematic diagram of the structure of the in-vivo catheter in the multi-balloon extra-aortic counterpulsation device of the present invention.

[0026] Figure 3 It is a schematic diagram of the balloon cavity structure of the IABP balloon in the inflated state in the multi-balloon extra-aortic counterpulsation device of the present invention.

[0027] Figure 4 It is a schematic diagram of the balloon cavity structure of the IABP balloon in the deflated state in the multi-balloon extra-aortic counterpulsation device of the present invention.

[0028] Figure 5 It is a schematic structural diagram of the end of the sac cavity where a hemostatic valve is arranged in the multi-balloon external aortic counterpulsation device of the present invention.

[0029] Figure 6 It is a structural schematic diagram of the diaphragm setting section of the in-vivo catheter in the external aortic counterpulsation device of the present invention.

[0030] Figure 7 It is a cross-sectional schematic diagram of the diaphragm section of the in-vivo catheter in the extra-aortic counterpulsation device of the present invention (in the enlarged state of the blood extraction cavity).

[0031] Figure 8 It is a cross-sectional schematic diagram of the diaphragm section of the in vivo catheter in the extra-aortic counterpulsation device of the present invention (in the expanded state of the perfusion cavity). DETAILED DESCRIPTION

[0032] The 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. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present invention and to enable the scope of the present invention to be fully communicated to those skilled in the art.

[0033] It should also be noted that the directions or positional relationships indicated by "left", "right", "inside" and "outside" in the present 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, and therefore cannot be understood as a limitation on the present invention.

[0034] Refer to the attached Figure 1 As shown, the multi-balloon extra-aortic counterpulsation device of this embodiment includes an intracorporeal catheter 1 for extending into the descending aorta and a balloon cavity 2 connected to the extracorporeal end of the intracorporeal catheter 1, and an IABP balloon 3 arranged inside the balloon cavity 2. One end of the IABP balloon 3 extends out of the balloon cavity 2 and is used to be connected to a controller 4, and the controller 4 controls the inflation and deflation of the balloon.

[0035] Refer to the attached Figure 2 As shown, a plurality of through holes 11 are provided on the inner end side wall of the intracorporeal catheter 1, the outer end of the intracorporeal catheter 1 is configured as a Luer connector, and the first interface connecting the sac cavity 2 and the intracorporeal catheter 1 is also configured as a Luer connector, which is used for the sealed connection between the intracorporeal catheter 1 and the sac cavity 2, so as to realize the communication between the intracorporeal catheter 1 and the inside of the sac cavity 2. That is, when the intracorporeal catheter 1 enters the body, the intracorporeal catheter 1, the sac cavity 2 and the blood vessels in the body form a closed space, and blood will flow in the passage formed by them. The space is an extension section of the human aorta. Of course, the intracorporeal catheter 1 and the sac cavity 2 can also adopt any other existing sealed connection mechanism to ensure the sealed connection between the intracorporeal catheter 1 and the sac cavity 2.

[0036] Refer to the attached Figures 3 to 5 As shown, the capsule cavity 2 includes a plurality of IABP balloons 3 arranged in parallel, each IABP balloon 3 extends out of the capsule cavity 2 through a sealing valve 6, preferably a hemostatic valve, to achieve a sealed connection between the IABP balloon 3 and the capsule cavity 2 to prevent blood from flowing out, as shown in the attached Figure 5 The IABP balloon 3 of this embodiment can adopt the existing IABP balloon, and the balloon head end is provided with an inflatable balloon, and the gas of the inflatable balloon comes from the controller 4, under the action of the controller 4, the inflation and deflation actions can be realized.

[0037] It should be noted that in this embodiment, the multiple IABP balloons 3 need to be inflated and deflated at the same time. When the multiple IABP balloons 3 are deflated at the same time, the space occupied by the balloons in the sac cavity 2 is reduced, and the blood in the descending aorta 10 is sucked into the sac cavity 2 by the "cavitation phenomenon". Figure 4 When the multiple IABP balloons 3 are inflated at the same time, the space occupied by the balloons in the sac cavity 2 becomes larger, pushing the blood in the sac cavity 2 back into the body, as shown in the attached Figure 3 As shown, extra-aortic blood counterpulsation is achieved.

[0038] In this embodiment, the capsule cavity 2 includes 2-10 IABP balloons 3, preferably 3-6, which can reduce loss and achieve a cardiac output greater than 5L / min. In order to accommodate the IABP balloon 3, the total length of the capsule cavity 2 is greater than the balloon section of the IABP balloon, and the length ranges from 200 to 400 mm.

[0039] Specifically, the overall length of the in-vivo catheter 1 is 500-1000mm, and it can be preferably set to 600, 750, 900mm specifications to adapt to people of different heights. The outer diameter of the in-vivo catheter 1 is 7F at the minimum and 24F at the maximum, that is, its lumen diameter is: 2.2-9mm. The principle of setting the diameter is that the lumen diameter of the human aorta is generally about 10mm, so the outer diameter of the catheter must be smaller than the inner diameter of the blood vessel, and a certain gap must be retained. A unilateral gap of 0.5mm is necessary, so the outer diameter of the catheter cannot exceed 9mm at most, otherwise it will damage the inner wall of the blood vessel. Of course, the catheter cannot be too thin. If the catheter is too thin, it will be very laborious to draw blood outward and perfuse inward, the load will be very large, and the hysteresis effect of the liquid will become very obvious. At the same time, during the process of strong suction, a vacuum phenomenon will occur, which will lead to the destruction of blood cells, and may also produce gas embolism, endangering the life safety of the patient.

[0040] In addition, the length of the opening section of the through hole 11 of the in-vivo catheter 1 is 320-520 mm. The through hole 11 is provided in multiples to reduce the load during blood drawing and perfusion, so as to facilitate the flow of blood. The diameter of the through hole 11 is 1-4 mm and is evenly distributed around the tube wall. The distribution method is not limited. It can be spirally distributed or divided into circles. The best way is to ensure that the spacing between any two holes is equal, and the range of the spacing is: 1-10 mm. Too small spacing will destroy the overall rigidity of the catheter, and too large spacing will increase the suction load. The same is true for the size of the aperture. If the aperture is too small, the suction load will increase and the difficulty will increase. If the aperture is too large, the overall rigidity will be destroyed, making the catheter easily damaged. Note: The starting position of the opening on the tube wall should not be too close to the puncture port into the body, otherwise it will easily cause bleeding. The range of the preferred opening starting section from the puncture point position L is: 20-80 mm. If the distance is too short, blood may seep due to excessive pressure during the process of blood suction and perfusion. If the distance is too long, the blind cavity area without opening will be large, which will increase the suction load and make suction more difficult. The optimal L range is 30 to 50 mm.

[0041] In this embodiment, a pressure sensor 5 is provided on the outer side of the inner end of the in-vivo catheter 1 for real-time monitoring of blood pressure and transmitting the signal to the controller 4 to form a control trigger mode.

[0042] The application principle of the extra-aortic counterpulsation device is as follows: through a puncture operation, the intracorporeal catheter 1 is inserted 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 intracorporeal catheter 1 is punctured, the blood in the body will be drawn out along the catheter into the capsule cavity 2. By controlling the inflation and deflation of the IABP balloon 3 by the controller 4, the blood in the descending aorta 10 in the body will be drawn out along the catheter into the extracorporeal capsule cavity 2 through the through hole 11, and then perfused and pressed back into the descending aorta 10 in the body, thereby realizing extra-aortic blood counterpulsation.

[0043] A preferred embodiment is as follows: Figure 6 As shown, the interior of the intracorporeal catheter 1 is also provided with a diaphragm 15 for dividing the interior of the catheter into a blood drawing chamber 13 and a perfusion chamber 14, one end of the diaphragm 15 is located at the beginning of the opening of the intracorporeal catheter 1, and the other end of the diaphragm 15 is located at the extracorporeal end of the intracorporeal catheter 1.

[0044] Specifically, the two 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 inclined 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, as shown in the attached Figure 6 As shown, it is used to guide the flow of blood in the catheter in the body, thereby ensuring smooth blood flow in and out.

[0045] 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. The optimal hardness range of the elastic material is below 30 degrees. During the blood drawing process, the elastic film deforms to the left, that is, it is squeezed toward the perfusion chamber 14, so that the blood drawing chamber 13 becomes larger and the perfusion chamber 14 becomes smaller. Figure 7 During the perfusion process, the film deforms to the right, that is, it is pressed toward the blood extraction chamber 13, so that the perfusion chamber 14 becomes larger and the blood extraction chamber 13 becomes smaller, as shown in the attached figure. Figure 8 As 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 chamber 13 and the perfusion chamber 14 is the same. The reason why it is designed as a double-chamber 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, because of the high frequency and fast speed, the liquid cannot be quickly fed back, and a vacuum phenomenon will naturally occur, the liquid will collide with each other, and the turbulence will be serious; but if it is set as a double channel, the blood can be sucked in from one end and perfused back from the other end without mutual influence, then the corresponding speed will also be accelerated, the vacuum and turbulence phenomena will also disappear, and the required external power will also be greatly reduced. Therefore, the catheter with a double-chamber structure of the present application can ensure the unidirectional flow of blood. Furthermore, if only an inelastic film is provided to divide a lumen into two cavities, the cross section of a single cavity will become very small, less than or equal to half of the original cross section, which will increase the difficulty of suction and perfusion. Therefore, the present application creates an elastic film and sets a trumpet structure at both ends, which can effectively ensure the unidirectional flow of blood and ensure the maximum cross section in each process, thereby greatly reducing external power and achieving unidirectional flow of blood.

[0046] More specifically, the in vivo catheter 1 is made of PTFE, PU, ​​Pebax or PE polymer material and is prepared by blow molding or extrusion. The sac cavity 2 is made of silicone rubber, polyurethane, PTFE, PU, ​​Pebax, PE and other materials with a hardness of more than 65 degrees and is formed by injection molding or blow molding.

[0047] In this embodiment, the controller 4 adopts the controller of the existing IABP system to provide gas for the IABP balloon 3. Preferably, a helium pump is provided in the controller 4 to provide helium for the IABP balloon.

[0048] The controller 4 has the following functions: 1) Waveform display: ECG, AP, BP waveform; ECG adjustable piston action interval; can accurately display catheter pressure; 2) Physiological data display: heart rate, assisted systolic pressure / diastolic pressure / mean pressure / counterpulsation pressure, unassisted systolic pressure / diastolic pressure / mean pressure; 3) Icon display: battery capacity, piston status; can display the pressure value in the respiratory cavity; 4) Control methods include: single touch screen control; button control; alarm angle control; key / common function dual control: touch screen / button: auxiliary start, auxiliary frequency, screen freeze, print, reference line setting. 5) Working modes include automatic and manual; the working mode conversion process does not affect normal counterpulsation; when the working mode is converted, the device automatically retains the original settings; automatic mode: automatically select the signal source; automatically select the trigger mode (6 types); automatically select the phase algorithm; real-time evaluation of the ECG lead status; automatically select 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 can be performed: real-time calculation of balloon perfusion speed, evaluation of R wave exhaust safety; 8) There are 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, can be precisely adjusted, adjustment accuracy 0.5ml; 11) Automatic water removal (the driver will generate heat when working, and needs to be cooled, which will produce condensed water, so 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: self-test results of the checklist prompt function; 14) Alarm history record: can display and print the latest 100 alarms.

[0049] Of course, the controller 4 may also adopt other structures as long as it can achieve functions similar to those of the IABP system controller.

[0050] The multi-balloon external aortic counterpulsation device of the present invention places the IABP balloon outside the body instead of inside the body like the IABP system, because the length and diameter of the human aorta in the body are limited after all, and the IABP device can only provide three specifications of 30cc, 40cc, and 50cc at most, so the maximum cardiac output provided is no more than 1L / min. After the IABP balloon is placed outside the body, the number and volume of the IABP balloons can be designed according to the maximum cardiac output, so that the actual cardiac output is greater than 5L / min, which completely solves the huge defect problem of insufficient cardiac output of IABP, and the overall device still retains all the advantages of IABP, with high compatibility and low cost.

[0051] 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 may make some simple modifications, equivalent changes or modifications using the technical contents disclosed above, which all fall within the protection scope of the present invention.

Claims

1. A multi-balloon external aortic counterpulsation device, characterized in that: It comprises an intracorporeal catheter for extending into the descending aorta, a balloon cavity connected to the extracorporeal end of the intracorporeal catheter, and an IABP balloon arranged inside the balloon cavity, one end of the IABP balloon extending out of the balloon cavity is used to connect to a controller, and the balloon is inflated and deflated under the control of the controller; A plurality of through holes are provided on the inner end side wall of the in-vivo catheter, and the outer end of the in-vivo catheter is sealedly connected to the first interface of the cystic cavity, so that the in-vivo catheter is communicated with the inside of the cystic cavity; The sac cavity includes a plurality of IABP balloons arranged in parallel, each of which extends out of the sac cavity through a sealing valve, and the plurality of IABP balloons are inflated and deflated simultaneously. When the plurality of IABP balloons are deflated simultaneously, the space occupied by the balloons in the sac cavity is reduced, and blood in the descending aorta is sucked into the sac cavity. When the plurality of IABP balloons are inflated simultaneously, the space occupied by the balloons in the sac cavity is enlarged, and the blood in the sac cavity is pushed back into the body, thereby realizing the extra-aortic blood counterpulsation effect. The interior of the intracorporeal 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 intracorporeal catheter, and the other end of the diaphragm is located at the extracorporeal end of the intracorporeal catheter.

2. The multi-balloon extra-aortic counterpulsation device according to claim 1, characterized in that: The balloon cavity includes 2-10 IABP balloons.

3. The multi-balloon extra-aortic counterpulsation device according to claim 1, characterized in that: The first interface of the sac cavity and the outer end interface of the in vivo catheter adopt mutually matching Luer connectors.

4. The multi-balloon extra-aortic counterpulsation device according to claim 1, characterized in that: A pressure sensor is arranged outside the inner end of the in-vivo catheter.

5. The multi-balloon extra-aortic counterpulsation device 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.

6. The multi-balloon extra-aortic counterpulsation device according to claim 1, characterized in that: 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.

7. The multi-balloon extra-aortic counterpulsation device according to claim 6, characterized in that: The diaphragm is an elastic film.

8. The multi-balloon extra-aortic counterpulsation device according to claim 7, characterized in that: The in vivo catheter is made of PTFE, PU, ​​Pebax or PE polymer materials and is prepared by blow molding or extrusion technology. The sac cavity is made of silicone rubber, polyurethane, PTFE, PU, ​​Pebax or PE polymer materials with a hardness of more than 65 degrees and is prepared by injection molding or blow molding technology. The film is made of silicone rubber, polyurethane, PTFE, PU, ​​Pebax or PE medical polymer materials with elasticity and a hardness of less than 30 degrees.

9. The multi-balloon external aortic counterpulsation device according to claim 1, characterized in that: The controller adopts the controller of the IABP system to provide inflation and deflation gas for the IABP balloon.

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