Adaptive vena cava occlusion balloon ventricular assist system

Abstract

The application discloses a self-adaptive vena cava occlusion balloon ventricular assist system, which comprises a balloon catheter device and a control device. The balloon catheter device comprises a catheter, a balloon arranged on the catheter and close to the proximal end of the catheter, and a joint arranged on the distal end of the catheter. The catheter is provided with a first pressure cavity, a second pressure cavity and a liquid delivery cavity. The first pressure cavity is used for connecting the first blood pressure measuring port and the joint and is connected with the first blood pressure sensor through a first catheter. The second pressure cavity is arranged on the catheter in a lengthwise direction and is used for connecting the second blood pressure measuring port and the joint and is connected with the second blood pressure sensor through a second catheter. The liquid delivery cavity is used for connecting the inside of the balloon and the joint and is connected with a liquid delivery pump through a liquid delivery catheter. A micro pressure sensor is attached to the outer wall of the balloon, and a signal line led out from the micro pressure sensor is connected with a signal acquisition module through a signal extension line. The application can adjust the pressure of the balloon on the blood vessel wall during occlusion according to the change of the vena cava diameter, improve the occlusion effect and avoid damaging the blood vessel.

Description

Technical Field

[0001] This invention relates to a ventricular assist system, and more particularly to an adaptive vena cava occlusion balloon ventricular assist system. Background Technology

[0002] Acute decompensated heart failure (ADHF) is a clinical condition in patients with chronic heart failure whose condition has stabilized, but which is caused by various triggers leading to a rapid deterioration of cardiac function and worsening of symptoms such as dyspnea. Current treatments primarily involve diuretics and vasodilators, but 60%-80% of patients still experience persistent congestion at discharge, and drug treatment may cause side effects such as kidney damage and hypotension, making it difficult to quickly and effectively relieve the problem of elevated cardiac filling pressure.

[0003] To address these issues, vena cava occlusion has gradually gained attention. The superior vena cava (SVC) carries about one-third of the venous return to the heart. Theoretically, occluding the SVC can reduce cardiac preload and lower cardiac filling pressure, while avoiding severe hypotension caused by inferior vena cava (IVC) occlusion (the IVC carries 60% of the venous return, and complete occlusion will rapidly reduce cardiac output and systemic blood pressure).

[0004] Existing SVC occlusion devices, such as the early preCARDIA system, primarily consist of a balloon catheter device. This device mainly includes a catheter with a balloon attached. By controlling the inflation and deflation of the balloon, the vena cava is intermittently occluded. While this can reduce filling pressure to some extent, it has the following drawbacks: a lack of real-time monitoring of the contact pressure between the balloon and the vena cava wall, making it difficult to maintain a safe and effective occlusion pressure. Studies have shown that 10-12 mmHg is the ideal range for occlusion pressure, ensuring complete occlusion while remaining below the vessel wall's tolerance threshold. However, in practice, controlling the balloon pressure on the vessel wall is difficult, especially during changes in patient respiration and position. Fluctuations in the vena cava diameter further complicate balloon inflation and deflation control. Over-inflation can damage the vessel wall, while under-inflation can cause slit shunts, leading to poor treatment outcomes.

[0005] Therefore, designing a ventricular assist device that can adjust the balloon occlusion pressure to adapt to changes in the diameter of the vena cava is an urgent problem to be solved. Summary of the Invention

[0006] The purpose of this invention is to provide an adaptive balloon ventricular assist system for vena cava occlusion, which can adjust the balloon pressure on the vessel wall during occlusion according to changes in the diameter of the vena cava, thereby improving the occlusion effect and avoiding damage to the vessel.

[0007] To achieve the above objectives, the present invention adopts the following technical solution: An adaptive balloon ventricular assist system for vena cava occlusion includes a balloon catheter assembly and a control device. The control device includes a first blood pressure sensor, a second blood pressure sensor, an infusion pump, a signal acquisition module, and a control module. The balloon catheter assembly includes a catheter with a balloon located proximally on the catheter and a connector attached to the distal end of the catheter. The catheter has a first pressure chamber, a second pressure chamber, and an infusion chamber. The first pressure chamber connects a first blood pressure measurement port near the distal end of the balloon to the connector and is connected to the first blood pressure sensor via the first catheter. The second pressure chamber is connected to... The balloon is configured to connect the proximal port of the catheter, which serves as the second blood pressure measurement port, to the connector and, via the second catheter, to the second blood pressure sensor; the infusion chamber connects the interior of the balloon to the connector and, via the infusion catheter, to the infusion pump; at least two miniature pressure sensors are attached to the outer wall of the balloon; the signal lines from the miniature pressure sensors are electrically connected to the signal acquisition module via signal extension lines; the pressure measuring chips within the first and second blood pressure sensors are electrically connected to the signal acquisition module; and the signal acquisition module, the infusion pump, and the control module are electrically connected.

[0008] The advantages of this invention are: This invention can adjust the pressure of the balloon on the vessel wall during occlusion according to the changes in the diameter of the vena cava, significantly improving the occlusion effect, avoiding damage to the vessel, and solving the problems of incomplete or excessive occlusion leading to poor hemodynamic regulation and high risk of vascular damage in existing technologies. It provides a safer and more effective treatment for ADHF patients. Attached Figure Description

[0009] Figure 1 This is a schematic diagram of the composition of the adaptive vena cava occlusion balloon ventricular assist system of the present invention (the balloon is inflated).

[0010] Figure 2 This is a schematic diagram of the balloon catheter device.

[0011] Figure 3 This is a schematic diagram of the balloon and its miniature pressure sensor.

[0012] Figure 4 This is a partial cross-sectional schematic diagram of the catheter and the balloon attached to it.

[0013] Figure 5 This is a schematic diagram of the cross-section of the catheter.

[0014] Figure 6 This is a partial schematic diagram of the adaptive vena cava occlusion balloon ventricular assist system of the present invention implanted in the superior vena cava (the balloon is in a contracted state). Detailed Implementation

[0015] like Figures 1 to 6 As shown, this invention proposes an adaptive balloon ventricular assist system for vena cava occlusion, comprising a balloon catheter device 100 and a control device 300. The control device 300 includes a first blood pressure sensor 310, a second blood pressure sensor 320, an infusion pump 330, a signal acquisition module 340, and a control module 350. The balloon catheter device 100 includes a catheter 20, with a balloon 10 located near its proximal end and a connector 30 installed at the distal end of the catheter 20. The catheter 20 has a first pressure chamber 210, a second pressure chamber 220, and an infusion chamber 230. The first pressure chamber 210 connects a first blood pressure measurement port 201 near the distal end of the balloon 10 to the connector 30 and is connected to the first blood pressure sensor 310 via the first catheter 311. The second pressure chamber 220 is continuously disposed on the catheter 20 and is used to connect to the second blood pressure sensor 310. The catheter 20 of the measuring port 202 is connected to the connector 30 and the second blood pressure sensor 320 via the second catheter 321; the infusion chamber 230 is used to connect the inside of the balloon 10 and the connector 30 and is connected to the infusion pump 330 via the infusion catheter 331; at least two sheet-like miniature pressure sensors 12 are attached to the outer wall of the balloon 10; the signal lines 13 led out from the miniature pressure sensors 12 are electrically connected to the signal acquisition module 340 via the signal extension line 341; the pressure measuring chips in the first blood pressure sensor 310 and the second blood pressure sensor 320 are electrically connected to the signal acquisition module 340; the signal acquisition module 340, the infusion pump 330, and the control module 350 are electrically connected; the first blood pressure sensor 310 and the second blood pressure sensor 320 are used to measure blood pressure at different locations in the superior vena cava (SVC), that is, the first blood pressure sensor 310 is used to measure... Figure 1 The blood pressure at point b shown is measured by the second blood pressure sensor 320. Figure 1 The blood pressure at point a is shown to assist the surgeon in treatment. The balloon 10 adopts a stepwise inflation strategy, including: first inflating the balloon 10 to maintain the pressure on the superior vena cava (SVC) vessel wall at 5 mmHg; after a set time, the balloon 10 continues to inflate to increase the pressure to 10 mmHg; the balloon 10 completely occludes the superior vena cava (SVC) to reduce the blood flow impact at the moment of occlusion by pre-emptively draining 20% ​​to 30% of the blood in the superior vena cava (SVC).

[0016] like Figure 4 The catheter 20 is provided with an infusion port 203, which is located in the inner cavity 16 of the balloon 10. The infusion port 203 is connected to the connector 30 through the infusion cavity 230.

[0017] In practical design, such as Figure 5The catheter 20 is also provided with a signal line cavity 240. The signal line cavity 240 is used to connect the signal line port 204 located near the distal end of the balloon 10 with the connector 30. The signal line 13 led out from the miniature pressure sensor 12 enters the signal line cavity 240 from the signal line port 204 and is connected to the signal extension line 341 through the connector 30.

[0018] like Figure 3 All miniature pressure sensors 12 are evenly distributed circumferentially on the outer wall of balloon 10 with the axis of catheter 20. The signal lines 13 led out by the miniature pressure sensors 12 are attached to the outer wall of balloon 10, arranged in a spiral shape and extended to catheter 20. That is, before the signal lines 13 enter the signal line port 204, they are all arranged in a spiral shape and attached to the outer wall of balloon 10 and outer wall of catheter 20.

[0019] In the actual design, the signal line port 204 and the first blood pressure measuring port 201 are relatively close, and there are no specific restrictions on their positional relationship. The standard is that the signal line 13 does not interfere with the measurement of the first blood pressure measuring port 201.

[0020] In practical applications, it is advisable to use 3-4 miniature pressure sensors 12. Each miniature pressure sensor 12 has two signal lines 13, and each miniature pressure sensor 12 transmits signals independently.

[0021] like Figure 2 The connector 30 includes a first connector 31, a second connector 32, a third connector 33, and a signal line connector 34. The first connector 31 connects the first pressure chamber 210 to the first conduit 311; the second connector 32 connects the second pressure chamber 220 to the second conduit 321; the third connector 33 connects the infusion chamber 230 to the infusion conduit 331; and the signal line connector 34 connects the signal line 13 from the miniature pressure sensor 12 to the signal extension line 341. In other words, the first connector 31, the second connector 32, and the third connector 33 are pipes, while the signal line connector 34 is a cable.

[0022] like Figure 5 The catheter 20 has four lumens: a first pressure chamber 210, a second pressure chamber 220, an infusion chamber 230, and a signal line chamber 240. All four lumens are tubular channels with a typically circular cross-section. The four lumens do not interfere with each other, and their distribution is unrestricted. Preferably, the cross-sectional area of ​​the first pressure chamber 210 and the second pressure chamber 220 is larger than that of the infusion chamber 230 and the signal line chamber 240.

[0023] In this invention, the first blood pressure sensor 310 is used to measure blood pressure at the proximal port of the catheter 20, or the second blood pressure measuring port 202. Figure 1 The blood pressure at point a shown is measured by the second blood pressure sensor 320, which is used to measure the blood pressure at the first blood pressure measuring port 201. Figure 1 Blood pressure at point b shown. In practical applications, the first pressure chamber 210, the first connector 31, the first catheter 311 and its connected first blood pressure sensor 310, and the second pressure chamber 220, the second connector 32, the second catheter 321 and its connected second blood pressure sensor 320 are used to inject saline solution to monitor blood pressure. In other words, the first pressure chamber 210 and the second pressure chamber 220 on the catheter 20 allow blood to enter and can be used to deliver medication (such as saline solution) into the blood vessels. Furthermore, the second pressure chamber 220 is also used for guidewire intervention to guide the balloon 10 into the vena cava. The infusion chamber 230 is used to deliver and withdraw fluid into the balloon cavity 16 of the balloon 10. The infusion pump 230 delivers fluid to the balloon 10, the balloon 10 inflates, the infusion pump 230 withdraws the fluid, and the balloon 10 contracts. The signal line chamber 240 is used to arrange the signal line 13.

[0024] In this invention, the first blood pressure sensor 310 and the second blood pressure sensor 320 are existing invasive blood pressure sensors, which include a pressure measuring chip placed inside the sensor housing, and should be equipped with an infusion device and valves accordingly. The structure of invasive blood pressure sensors and the principle of blood pressure measurement are well known technologies and will not be described in detail here. Blood pressure is generally between 10 kPa and 15 kPa.

[0025] In this invention, the miniature pressure sensor 12 is an existing industrial-grade general-purpose pressure sensor, and its structure and pressure measurement principle are well-known technologies, which will not be described in detail here.

[0026] In this invention, the catheter 20 and connector 30 are made of common TPU plastic raw materials, PVC, silicone and other polymer materials. Similarly, the first catheter 311, the second catheter 321 and the infusion catheter 331 are made of TPU plastic raw materials, PVC, silicone and other polymer materials. The guidewire is an existing medical device in this field.

[0027] Better, such as Figure 3 and Figure 4 The balloon 10 includes a main body 112 in the shape of an elliptical body, and the two ends of the main body 112 are provided with trumpet-shaped connecting parts 111, which are used to fix and connect to the outer wall of the catheter 20.

[0028] In practical design, the thickness of the balloon 10 can be reasonably designed. During actual installation, the end of the connecting part 111 of the balloon 10 is connected to the outer wall of the catheter 20 by means of adhesive bonding or other methods. The inner cavity 16 of the balloon is used to fill with fluid. After the main body 112 expands, it is used to occlude the vena cava; after the main body 112 contracts, it is used to empty the vena cava.

[0029] In actual design, the balloon 10 is made of rubber or shape memory polymer with a certain degree of elasticity, wherein the shape memory polymer is, for example, polyurethane foam (PU).

[0030] If the balloon 10 is made of shape memory polymer, when the diameter of the superior vena cava (SVC) fluctuates due to changes in the patient's breathing or body position, the shape memory polymer balloon 10 can adaptively adjust to the degree of expansion of the blood vessel based on its own elastic properties. That is, the shape memory polymer allows the balloon 10 to undergo a certain radial deformation following changes in the blood vessel diameter, thereby improving the completeness of occlusion and avoiding strong pressure on the blood vessel wall that could lead to ischemia. In summary, the combination of the shape memory polymer balloon 10 and the miniature pressure sensor 12 can further enhance the occlusion effect.

[0031] In addition, the control device 300 may also include a display device (not shown) for displaying signal data, monitoring waveforms, blocking and venting related data, etc.

[0032] In this invention, the signal acquisition module 340 is used to acquire signals monitored by the first blood pressure sensor 310, the second blood pressure sensor 320, and the miniature pressure sensor 12. The control module 350 is used to control the balloon 10 to expand and contract by means of the infusion pump 330 based on the relevant acquisition signals fed back by the signal acquisition module 340, so as to occlude and empty the vena cava.

[0033] In this invention, the infusion pump 330, the signal acquisition module 34 and the control module 350 are technologies well known in the art. The infusion pump 330 should also be reasonably equipped with a liquid storage tank and a control valve, etc.

[0034] In this invention, the end closer to the operator (such as a doctor or nurse) is defined as "far", while the end farther from the operator, that is, the end closer to the patient's heart, is defined as "proximal". In other words, for the balloon catheter device 100, the end that enters the patient first is defined as the proximal end, and the other end as the distal end.

[0035] like Figure 1 In the diagram, SVC represents the superior vena cava, IVC the inferior vena cava, RA the right atrium, and RV the right ventricle.

[0036] In heart failure patients, elevated right atrial ventricular (RA) blood pressure reduces the pressure gradient between the superior vena cava (SVC) and the right atrial RA, significantly slowing blood flow velocity and disrupting normal cyclical fluctuations. Obstructed venous return leads to proximal dilation of the inferior vena cava (IVC), and weakened pulsation with respiration, resulting in "extrahepatic blood flow" in the hepatic veins. Right ventricular dysfunction has already affected hepatic circulation. In heart failure patients, right atrial RA blood pressure typically rises to 12-25 mmHg after heart failure. Therefore, lowering right atrial RA blood pressure is crucial to effectively relieve congestion and promote diuresis, thus improving blood supply to the brain and lower limbs.

[0037] refer to Figure 6The infusion pump 330 inflates the balloon 10, allowing the balloon catheter device 100 to be inserted into the superior vena cava (SVC) through a guidewire (which penetrates the second pressure chamber 220) via a site in the heart failure patient (such as the jugular vein). The balloon 10 is then inflated, artificially blocking blood flow to the SVC, forcing blood back into the heart, reducing right atrial preload, and reconstructing an effective pressure gradient to promote diuresis and relieve congestion. (Continue to refer to...) Figure 6 and Figure 1 The balloon 10 and catheter 20 of the balloon catheter device 100 are partially inserted into the patient's superior vena cava (SVC) and are located inside the patient's body, while the connector 30 and control device 300 are located outside the patient's body.

[0038] In use, the operator controls the expansion and contraction of the balloon 10 via the infusion pump 330 through the control device 300, thereby controlling the occlusion and emptying of the superior vena cava (SVC).

[0039] Furthermore, to achieve complete occlusion of the superior vena cava (SVC), the present invention incorporates multiple miniature pressure sensors 12 on the balloon 10. These sensors monitor the contact pressure between the outer wall of the balloon 10 and the SVC vessel wall in real time. The pressure signal is fed back to the control module 350 via the signal acquisition module 340, allowing the control module 350 to make judgments and analyses. If the pressure signal detected by any miniature pressure sensor 12 is below the stable pressure range, the infusion pump 330 increases the amount of fluid delivered to the balloon 10 to increase its inflation. Conversely, if the pressure signal detected by any miniature pressure sensor 12 is above the stable pressure range, the infusion pump 330 decreases the amount of fluid delivered to the balloon 10 to decrease its inflation. This ensures that the pressure of the balloon 10 on the SVC vessel wall remains stable within the stable pressure range, preventing insufficient balloon inflation leading to slit shunting and excessive balloon inflation damaging the vessel wall.

[0040] Preferably, the stable pressure range is designed to be 10 mmHg to 12 mmHg. This stable pressure range can overcome the mean venous pressure in the superior vena cava (SVC) to achieve complete occlusion, while also meeting the tolerance requirements of the vessel wall. In addition to monitoring pressure based on the miniature pressure sensor 12, if the balloon 10 is made of shape memory polymer material, the balloon 10 can finely adjust its expansion degree according to the fluctuation of the SVC vessel diameter (caused by changes in the patient's breathing or body position) to improve the completeness of occlusion and avoid strong pressure on the vessel wall that could lead to ischemia.

[0041] During the occlusion and emptying of the vena cava, blood pressure is continuously measured using the first blood pressure sensor 310. Figure 1 The blood pressure at point b shown is measured by the second blood pressure sensor 320. Figure 1 The blood pressure at point a shown is monitored by the first blood pressure sensor 310 and the second blood pressure sensor 320. The blood pressure signals are fed back to the control module 350 through the signal acquisition module 340, thereby assisting the surgeon in treatment by monitoring the blood pressure at different positions in the superior vena cava (SVC).

[0042] Furthermore, the control device 300 can employ the following control strategy for the inflation and contraction of the balloon 10.

[0043] For coordinated control of occlusion and emptying, intermittent occlusion is preferred to regulate the hemodynamic state of the superior vena cava (SVC). Specifically, a control cycle consists of occlusion lasting 5-10 minutes and emptying lasting 10-30 seconds. During the 5-10 minute occlusion period, the pressure of the balloon 10 against the SVC wall is maintained between 10-12 mmHg. This blocks venous return while simultaneously promoting blood flow within the SVC through collateral circulation via the azygos vein and hemiazygos vein. During the 10-30 second emptying period, the balloon 10 rapidly contracts to a diameter of 3-4 mm, allowing stagnant blood from the collateral circulation to flow back into the SVC, and then is aspirated into the right atrium (RV) by the negative pressure during diastole. This alternating occlusion and emptying cycle is repeated to complete the vena cava occlusion and emptying operation, achieving active emptying-refilling circulation of the SVC.

[0044] The balloon 10 employs a step-by-step inflation strategy. Specifically, the balloon 10 is first inflated to, for example, 18 mm in diameter, maintaining a low pressure of 5 mmHg on the superior vena cava (SVC) vessel wall. At this point, blood within the SVC is allowed to flow towards the heart through the partially occluded gap (the gap between the balloon 10 and the vessel wall). After a set time (e.g., 30 seconds), the balloon 10 is further inflated to, for example, 26 mm in diameter, increasing the pressure on the vessel wall to 10 mmHg, at which point the balloon 10 completely occludes the SVC. This process pre-emptively drains 20%–30% of the blood from the SVC, reducing the blood flow impact at the moment of occlusion.

[0045] Furthermore, during occlusion, if the pressure of balloon 10 against the SVC wall exceeds 15 mmHg, it is determined that there is a risk of balloon overinflation. Therefore, the infusion pump 330 is used to quickly withdraw the fluid, reducing the diameter of balloon 10 by 1 mm to 2 mm, and rapidly restoring it to a safe and stable pressure range. This mechanism avoids vascular damage caused by a sudden increase in pressure on the SVC wall, while effectively ensuring the occlusion effect and preventing the emptying process from being affected.

[0046] Based on the above control of superior vena cava SVC occlusion and emptying, a series of hemodynamic abnormalities caused by right atrial RA hypertension in heart failure patients have been effectively resolved, including: reduced pressure gradient between superior vena cava and right atrium, slowed blood flow velocity and loss of normal periodic fluctuations; obstruction of venous return leading to proximal dilation of inferior vena cava, weakened pulsation amplitude, and "extrahepatic blood flow" of hepatic veins, etc., which are problems of right heart failure affecting hepatic circulation.

[0047] The present invention has the following beneficial effects: 1. This invention monitors the occlusion pressure in real time through a pressure feedback mechanism, and can make rapid adjustments when abnormal, avoiding damage to blood vessels caused by a sudden increase in occlusion pressure, avoiding affecting the emptying process, and avoiding the impact of insufficient occlusion on the treatment effect, thus ensuring high treatment safety.

[0048] 2. The present invention has strong operational controllability. The balloon expansion and contraction are effectively controlled by the control device, which reduces errors caused by human operation and ensures the treatment effect.

[0049] The above description describes the preferred embodiments of the present invention and the technical principles applied thereto. For those skilled in the art, any obvious changes such as equivalent transformations or simple substitutions based on the technical solutions of the present invention, without departing from the spirit and scope of the present invention, shall fall within the protection scope of the present invention.

Claims

1. An adaptive balloon ventricular assist system for vena cava occlusion, characterized in that, The device includes a balloon catheter assembly and a control device. The control device includes a first blood pressure sensor, a second blood pressure sensor, an infusion pump, a signal acquisition module, and a control module. The balloon catheter assembly includes a catheter with a balloon located near its proximal end and a connector installed at the distal end of the catheter. The catheter has a first pressure chamber, a second pressure chamber, and an infusion chamber. The first pressure chamber connects a first blood pressure measurement port near the distal end of the balloon to the connector and, via the first catheter, to the first blood pressure sensor. The second pressure chamber extends along the entire length of the catheter, connecting the proximal end of the catheter (which serves as the second blood pressure measurement port) to the connector and, via the second catheter, to the second blood pressure sensor. The infusion chamber connects the interior of the balloon to the connector and, via the infusion catheter, to the infusion pump. At least two miniature pressure sensors are attached to the outer wall of the balloon. The signal lines from the miniature pressure sensors are electrically connected to the signal acquisition module via signal extension lines. The pressure-measuring chips within the first and second blood pressure sensors are electrically connected to the signal acquisition module. The signal acquisition module, the infusion pump, and the control module are electrically connected.

2. The adaptive vena cava occlusion balloon ventricular assist system as described in claim 1, characterized in that, The catheter is provided with an infusion port, which is located in the inner cavity of the balloon. The infusion port is connected to the connector via the infusion cavity.

3. The adaptive vena cava occlusion balloon ventricular assist system as described in claim 1, characterized in that, The catheter is also provided with a signal line cavity, which is used to connect the signal line port located near the distal end of the balloon to the connector. The signal line led out by the miniature pressure sensor enters the signal line cavity from the signal line port and is connected to the signal extension line through the connector.

4. The adaptive vena cava occlusion balloon ventricular assist system as described in claim 3, characterized in that, All of the aforementioned miniature pressure sensors are evenly distributed circumferentially on the outer wall of the balloon with respect to the axis of the catheter. The signal lines led out by the miniature pressure sensors are attached to the outer wall of the balloon, arranged in a spiral shape, and converge and extend to the catheter.

5. The adaptive vena cava occlusion balloon ventricular assist system as described in claim 3, characterized in that, The connector includes a first connector, a second connector, a third connector, and a signal line connector. The first connector is used to connect the first pressure chamber to the first conduit. The second connector is used to connect the second pressure chamber to the second conduit. The third connector is used to connect the infusion chamber to the infusion conduit. The signal line connector is used to connect the signal line from the miniature pressure sensor to the signal extension line.

6. The adaptive vena cava occlusion balloon ventricular assist system as described in claim 1, characterized in that, The balloon includes a main body in the shape of an ellipse, and the main body has flared connecting parts at both ends, which are used to fix and connect to the outer wall of the catheter.

7. The adaptive vena cava occlusion balloon ventricular assist system as described in claim 6, characterized in that, The balloon is made of rubber or shape memory polymer.

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