CN118750757A - A single-balloon external aortic counterpulsation device - Google Patents

Abstract

The invention discloses a single-balloon aortic external counterpulsation apparatus, which comprises an internal catheter, a balloon cavity, an external balloon and a controller which are sequentially connected, wherein a plurality of through holes are formed in the side wall of the extending end of the internal catheter, and the external end of the internal catheter is connected with the balloon cavity in a sealing way; the external air bag comprises an air conveying pipe and an air-filling air bag arranged at the head part of the air-filling air bag, the air-filling air bag is positioned in the air bag cavity, the tail part of the air conveying pipe is connected with the controller, the controller provides air-filling and air-discharging air for the air-filling air bag, when the air-filling air bag realizes air filling, the air bag cavity space is occupied, blood in the air bag cavity is pushed back into the body, when the air-filling air bag realizes air discharging, the air bag cavity space is enlarged, blood in the descending aorta is sucked into the air bag cavity, and the counterpulsation effect of blood outside the aorta is realized. The invention utilizes the inflation and deflation actions of the external air bag to realize the extrusion and suction of blood in the air bag cavity, utilizes the principle that the external air bag cavity and the air bag do not accept the internal space limitation, reasonably sets the air bag cavity and the air bag volume, greatly improves the cardiac output and meets the whole blood supply requirement of patients.

Description

A single-balloon external aortic counterpulsation device

Technical Field

The invention relates to the technical field of medical devices, and in particular to a single-balloon external aortic counterpulsation device.

Background Art

The 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.

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 the patients who used 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: 30cc, 40cc and 50cc.

Comparison of the use of IABP, ECOM, and artificial heart shows that IABP has absolute advantages in sheath size, bedside placement, difficulty of operation, retention time, postoperative management requirements, and risk of hemolysis. 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 the actual use effect of patients, it is significantly inferior to ECOM and artificial heart. In view of this major drawback of IABP equipment, international and domestic 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.

On this basis, the present application fully utilizes the advantages of the IABP device and creatively proposes a single-balloon external aortic counterpulsation device, which adopts the external aortic counterpulsation method and places the balloon outside the body, so that it can maximize the cardiac output and make up for the problem of too low cardiac output of the IABP device.

Summary of the invention

The technical problem to be solved by the present invention is to provide a single-balloon external aortic counterpulsation device, which can maximize the cardiac output and make up for the problem of too low cardiac output of IABP equipment.

In order to solve the above technical problems, the present invention provides a single-balloon external aortic counterpulsation device, comprising an in-vivo catheter, a balloon cavity, an extracorporeal balloon and a controller connected in sequence.

The in-vivo catheter is used to be inserted into the descending aorta, and a plurality of through holes are arranged on the side wall of the insertion end thereof, and the external end thereof is sealedly connected with the sac cavity, so that the in-vivo catheter is communicated with the inside of the sac cavity;

The extracorporeal airbag includes an air supply tube and an inflatable airbag arranged at its head. The inflatable airbag is located inside the bag cavity and is sealed and connected to the bag cavity. The tail end of the air supply tube is connected to the controller, and the controller provides inflation and deflation gas for the inflatable airbag. When the inflatable airbag is inflated, the bag cavity space is occupied and the blood inside the bag cavity is pushed back into the body. When the inflatable airbag is deflated, the bag cavity space becomes larger and the blood in the descending aorta is sucked into the bag cavity, thereby realizing the counterpulsation effect of the blood outside the aorta.

As a further improvement, the inflatable airbag is sealedly connected to the bag cavity via a sealing valve.

As a further improvement, the inflatable airbag adopts a semicircular or trapezoidal structure, the inflation port of the inflatable airbag is located at the center of the bottom plane side of the semicircular or trapezoidal structure, and the plane side of the inflatable airbag surrounding the inflation port is adhered to the inner wall of the bag cavity to form a sealed connection between the inflatable airbag and the bag cavity.

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

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

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.

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.

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.

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

Further improvement, the in vivo catheter is made of PTFE, PU, Pebax or PE polymer material and is prepared by blow molding or extrusion process, the film is made of elastic silicone rubber, polyurethane, PTFE, PU, Pebax or PE medical polymer material with a hardness of less than 30 degrees, the capsule 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 injection molding or blow molding process, the inflatable airbag is made of high-elastic silicone rubber or polyurethane material with a hardness of less than 30 degrees, and the air delivery tube is made of pebax, PE or polyurethane material with a hardness greater than that of the inflatable airbag material.

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

1. The single-balloon external aortic counterpulsation device of the present invention realizes squeezing and suctioning of blood inside the sac cavity by placing the inflatable balloon externally and utilizing its inflation and deflation action in the extracorporeal sac cavity, thereby realizing extracorporeal counterpulsation of blood in the descending aorta. The single-balloon external aortic counterpulsation device utilizes the cooperation of the extracorporeal sac cavity and the single inflatable balloon to facilitate the inflation volume setting of the inflatable balloon, greatly improving the cardiac output of the extracorporeal counterpulsation, truly overcoming the problem of low cardiac output caused by the limited volume when the existing balloon is built-in, and also overcoming the error caused by whether multiple balloons can be inflated and deflated simultaneously when placed externally, and the problem that multiple balloons are easily mismatched with the sac cavity space, that is, the single-balloon structure makes the sac cavity setting easier and simpler, the volume is easier to control, and the risk of bleeding is also greatly reduced. The single-balloon external aortic counterpulsation device has high compatibility, low cost, and good effect, and can achieve a cardiac output of more than 5L/min, meeting the patient's systemic blood supply needs and greatly improving the patient's blood supply status. In addition, the device keeps the inflatable balloon away from the aorta, so even if a high-risk event such as balloon leakage occurs, it can be blocked in time to prevent adverse effects on the patient, making it safer.

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.

3. By setting the elastic film and setting the two ends of the elastic film into a trumpet-mouth 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

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.

FIG1 is a schematic diagram of the structure of the single-balloon external aortic counterpulsation device of the present invention applied to a human body.

FIG. 2 is a schematic diagram of the structure of the in-vivo catheter in the single-balloon extra-aortic counterpulsation device of the present invention.

3 is a schematic diagram of the bag cavity structure of the inflatable bag in the single-balloon external aortic counterpulsation device of the present invention in an inflated state (the inflatable bag is arranged inside the bag cavity through a sealing valve).

4 is a schematic diagram of the bag cavity structure of the single-balloon external aortic counterpulsation device of the present invention in a deflated state of the inflated bag (the inflated bag is arranged inside the bag cavity through a sealing valve).

FIG5 is a schematic structural diagram of the end of the sac cavity where a hemostatic valve is provided in the single-balloon external aortic counterpulsation device of the present invention.

6 is a schematic diagram of the sac cavity structure of the single-balloon external aortic counterpulsation device of the present invention in a deflated state of the inflated sac (the flat side of the inflated sac is pasted inside the sac cavity).

FIG. 7 is a schematic structural diagram of the diaphragm setting section of the in-vivo catheter in the extra-aortic counterpulsation device of the present invention.

8 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).

9 is a schematic cross-sectional view of the diaphragm section of the in vivo catheter in the extra-aortic counterpulsation device of the present invention (in a perfusion cavity enlarged state).

DETAILED DESCRIPTION

The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the 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.

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.

1 , the single-balloon external aortic counterpulsation device of this embodiment includes an internal catheter 1 , a balloon cavity 2 , an external balloon 3 and a controller 4 which are connected in sequence.

As shown in FIG. 2 , the intracorporeal catheter 1 is used to extend into the descending aorta 10, and a plurality of through holes 11 are provided on the side wall of the extending end thereof, and the external end thereof is sealedly connected with the sac cavity 2, so that the intracorporeal catheter 1 communicates with the inside of the sac cavity 2. In this embodiment, the external end of the intracorporeal catheter 1 is configured as a Luer connector, and the 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 that the intracorporeal catheter 1 communicates with 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 of the human aortic blood vessel. Of course, the intracorporeal catheter 1 and the sac cavity 2 can also adopt any other existing sealing connection mechanism to ensure the sealed connection between the intracorporeal catheter 1 and the sac cavity 2.

As shown in Figures 3 to 5, the extracorporeal airbag 3 includes an air delivery tube 32 and an inflatable airbag 31 disposed at the head thereof, the inflatable airbag 31 is located inside the sac cavity 2, and the inflatable airbag 31 is sealed and connected to the sac cavity 2, and the tail of the air delivery tube 32 is connected to the controller 4. The controller 4 provides inflation and deflation gas to the inflatable airbag 31. When the inflatable airbag 31 is inflated, the space of the sac cavity 2 is occupied, and the blood inside the sac cavity 2 is pushed back into the body. When the inflatable airbag 31 is deflated, the space of the sac cavity 2 becomes larger, and the blood in the descending aorta 10 is sucked into the sac cavity 2 by the "cavitation phenomenon", so as to achieve the counterpulsation effect of the blood outside the aorta.

Since the inflatable airbag 31 is set outside the body, the size, shape and volume of the inflatable airbag 31 and the sac cavity 2 can be freely set, which provides the possibility of obtaining the maximum cardiac output. For example, in this embodiment, the sac cavity 2 is set to a cavity with a volume greater than 200ml, and the maximum volume of the inflatable airbag 31 in the filled state can reach 200ml, which can completely fill the internal space of the entire sac cavity 2, and completely push the blood back into the body from the sac cavity 2, avoiding thrombosis caused by blood retention in the sac cavity. In this embodiment, the shape of the sac cavity 2 can be set to a cylinder with a height of 60mm and a diameter of 66mm, or a sphere with a radius of 37mm, or a hemispherical, truncated cone, elliptical, etc. with a radius of 46mm, or a shape similar to the filled state of the inflatable airbag 31, which is conducive to the back pressure of the blood.

Specifically, the inflatable airbag 31 in this embodiment extends out of the cystic cavity 2 through the sealing valve 6, preferably a hemostatic valve, to achieve a sealed connection between the inflatable airbag 31 and the cystic cavity 2 to prevent blood from flowing out, as shown in Figure 5. The inflatable airbag 31 is preferably made of silicone rubber with a hardness of less than 30 degrees. After the airbag made of silicone rubber is inflated, the cystic wall around the inflation port will be tightly attached to the inner wall of the cystic cavity 2, which plays a role in further preventing blood from leaking from the hemostatic valve. Of course, the inflatable airbag 31 in this embodiment can also be set to a semicircular or trapezoidal structure, the inflation port of the inflatable airbag 31 is located at the center of the bottom plane side of the semicircular or trapezoidal structure, and the inflatable airbag plane side surrounding the inflation port is directly attached to the inner wall of the cystic cavity 2, forming a sealed connection between the inflatable airbag 31 and the cystic cavity 2, as shown in Figure 6, to better avoid leakage of blood inside the cystic cavity. The gas delivery pipe 32 is made of polyurethane, pebax or PE material having a harderness than that of the inflatable airbag 31 . Alternatively, the gas delivery pipe 32 may also be made by adding a layer of metal wire inside thereof by existing means to increase its rigidity and strength to play a role in gas delivery.

More specifically, the overall length of the in-vivo catheter 1 is 500-1000 mm, and it can be preferably set to specifications of 600, 750, and 900 mm 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: 2.2-9 mm. The principle of setting the diameter is that the lumen diameter of the human aorta is generally about 10 mm, 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 single-sided gap of 0.5 mm is necessary, so the outer diameter of the catheter cannot exceed 9 mm 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 also occur, thereby destroying blood cells, and gas embolism may also occur, endangering the patient's life safety.

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.

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.

The application principle of the single-balloon 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 cyst cavity 2. By controlling the inflation and deflation of the inflatable airbag 31 by the controller 4, the blood in the descending aorta 10 in the body will be drawn out along the catheter into the extracorporeal cyst cavity 2 through the through hole 11, and then perfused and pressed back into the descending aorta 10 in the body, to achieve extra-aortic blood counterpulsation.

A preferred embodiment is, as shown in FIG7 , the interior of the intracorporeal catheter 1 is further 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 starting point 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 .

Specifically, the two sides of the diaphragm 15 are respectively bonded to the inner wall of the in vivo catheter 1, and the two ends of the diaphragm 15 are inclined so that the inner end of the blood drawing cavity 13 and the outer end of the perfusion cavity 14 are in a trumpet-mouth structure, as shown in FIG. 7, which is used to provide guidance for the flow of blood in the in vivo catheter, thereby ensuring smooth blood inflow and outflow.

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 materials. 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, as shown in Figure 8. During the perfusion process, the film deforms to the right, that is, it is squeezed toward the blood drawing chamber 13, so that the perfusion chamber 14 becomes larger and the blood drawing chamber 13 becomes smaller, as shown in Figure 9. Thereby, the role of adaptive regulation during the suction and perfusion process is realized. 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 quickly feedback, and a vacuum phenomenon will naturally occur, the liquids collide with each other, and the turbulence is 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 disappear, and the required external power will be greatly reduced. Therefore, the catheter of the double-chamber structure of the present application can ensure the unidirectional flow of blood. Furthermore, if only an inelastic film is set 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 creative elastic film of the present application is set into a trumpet structure at both ends, which can effectively ensure the unidirectional flow of blood and ensure that the cross-section is the largest in each process, thereby greatly reducing the external power and realizing the unidirectional flow of blood.

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 process, and 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.

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

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/A-V mode, pacemaker A mode, AP mode, in-machine setting mode; 7) Balloon delay analysis can be performed: real-time calculation of the balloon perfusion rate and evaluation of the safety of R-wave exhaust; 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, with an adjustment accuracy of 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.

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.

The single-balloon external aortic counterpulsation device of the present invention places the balloon outside the body instead of inside the body like IABP, 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 balloon is placed outside the body, its size, shape, and volume can be designed according to the maximum cardiac output. For example, the volume of the inflated balloon can reach 200ml, and the actual cardiac output can reach 6L/min or more, which completely solves the huge defect problem of insufficient cardiac output of IABP, and the overall device still retains all the advantages of IABP.

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 are all within the protection scope of the present invention.

Claims (10)

1. A single-balloon external aortic counterpulsation device, characterized in that it comprises an in vivo catheter, a balloon cavity, an external balloon and a controller connected in sequence, The in-vivo catheter is used to be inserted into the descending aorta, and a plurality of through holes are arranged on the side wall of the insertion end thereof, and the external end thereof is sealedly connected with the sac cavity, so that the in-vivo catheter is communicated with the inside of the sac cavity; The extracorporeal airbag includes an air supply tube and an inflatable airbag arranged at its head. The inflatable airbag is located inside the bag cavity and is sealed and connected to the bag cavity. The tail end of the air supply tube is connected to the controller, and the controller provides inflation and deflation gas for the inflatable airbag. When the inflatable airbag is inflated, the bag cavity space is occupied and the blood inside the bag cavity is pushed back into the body. When the inflatable airbag is deflated, the bag cavity space becomes larger and the blood in the descending aorta is sucked into the bag cavity, thereby realizing the counterpulsation effect of the blood outside the aorta. 2. The single-balloon external aortic counterpulsation device according to claim 1 is characterized in that the inflatable balloon is sealedly connected to the balloon cavity via a sealing valve. 3. The single-balloon external aortic counterpulsation device according to claim 1 is characterized in that the inflatable balloon adopts a semicircular or trapezoidal structure, the inflation port of the inflatable balloon is located at the center of the bottom plane side of the semicircular or trapezoidal structure, and the plane side of the inflatable balloon surrounding the inflation port is adhered to the inner wall of the balloon cavity to form a sealed connection between the inflatable balloon and the balloon cavity. 4. The single-balloon external aortic counterpulsation device according to claim 1 is characterized in that the outer end interface of the balloon cavity and the in vivo catheter adopts a Luer connector that matches each other. 5. The single-balloon extra-aortic counterpulsation device according to claim 1 is characterized in that a pressure sensor is provided on the outer side of the inner end of the intracorporeal catheter. 6. The single-balloon external aortic counterpulsation device according to claim 1 is characterized in that the lumen diameter of the in vivo catheter is 2.2 to 9 mm, the length of the in vivo catheter opening section 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. 7. The single-balloon external aortic counterpulsation device according to any one of claims 1 to 6 is characterized in that the interior of the intracorporeal catheter is also provided with a diaphragm for dividing the interior of the catheter into a blood extraction chamber and a perfusion chamber, 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 extracorporeal end of the intracorporeal catheter. 8. The single-balloon external aortic counterpulsation device according to claim 7 is characterized in that the two sides of the diaphragm are respectively bonded to the inner wall of the in vivo catheter, and the two ends of the diaphragm are inclined so that the inner end of the blood drawing cavity and the outer end of the perfusion cavity are in a trumpet-mouth structure. 9. The single-balloon external aortic counterpulsation device according to claim 8, characterized in that the diaphragm is made of an elastic film. 10. The single-balloon extra-aortic counterpulsation device according to claim 9 is 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 film is made of elastic silicone rubber, polyurethane, PTFE, PU, Pebax or PE medical polymer material with a hardness of less than 30 degrees, the capsule 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 injection molding or blow molding process, the inflatable airbag is made of high-elastic silicone rubber or polyurethane material with a hardness of less than 30 degrees, and the air delivery tube is made of pebax, PE or polyurethane material with a hardness greater than that of the inflatable airbag material.