A multi-balloon percutaneous mechanical circulatory assist device

Abstract

The present application relates to a kind of multi-balloon percutaneous mechanical circulation auxiliary device, it includes first balloon, second balloon, catheter and trachea component;First balloon and second balloon are sequentially arranged on catheter in the direction of distal end to proximal end, first balloon and second balloon are communicated with outside gas supply system by trachea component, and first balloon and second balloon can be simultaneously inflated or contracted by trachea component;The outer diameter of first balloon when inflation is greater than the outer diameter of second balloon when inflation.The present application is based on the first balloon being arranged on the distal end side relative to the second balloon, in the first aspect, the speed and blood volume of inflow blood are increased;In the second aspect, based on the first balloon being increased, the swing of second balloon when inflation and contraction can be reduced, the beating of distal end to blood vessel wall is reduced, so as to protect blood vessel wall;In the third aspect, based on the outer diameter of first balloon when inflation is greater than the outer diameter of second balloon when inflation, when second balloon is inflated, first balloon can reduce blood reflux.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices for cardiac intervention, in particular to a percutaneous mechanical circulatory support device with multiple balloons. BACKGROUND

[0002] Heart failure is mainly characterized by the inability of the heart to work normally, resulting in the inability of blood to be discharged from the veins and the inability of sufficient blood to be obtained in the arteries. Under normal circumstances, left heart failure is more common. Heart failure can occur as a complication or acute symptom, and common situations are: (1) patients with high-risk coronary artery disease need to undergo percutaneous coronary intervention (PCI), and such patients are often accompanied by heart failure, and myocardial ischemia or arrhythmia may occur during treatment, which is difficult to tolerate, and there is a risk of malignant hemodynamic changes, so a heart assist device is needed to restore ventricular function during treatment, and it is particularly urgent to restore left ventricular function; (2) cardiogenic shock is an extreme manifestation of heart failure, and severe heart failure causes acute peripheral circulatory failure. Such an acute disease also needs a fast and efficient heart assist device to help the patient restore ventricular function.

[0003] The existing intra-aortic balloon pump (IABP) on the market has low flow, whipping effect during pulsation, and damage to the blood vessel wall. The working principle of IABP is to place a balloon in the aorta, which occupies a position in the aorta when the balloon is inflated, and a vacuum area is formed in the region at the moment of contraction, which promotes blood flow to the vacuum area, thereby forming a blood pressure difference and increasing the blood flow in the aorta. However, when the inflation volume of the balloon is designed to be too large, the beating of the blood vessel wall during inflation and contraction is serious, causing damage to the blood vessel, and when the inflation volume is designed to be too small, the blood flow of the IABP is affected. At the same time, since the balloon has no fixing mechanism in the aorta, it will constantly swing to form a whipping effect during the inflation and contraction cycle, which will beat the arterial wall and cause damage to the blood vessel. The above problems need to be solved. SUMMARY

[0004] The present application discloses a percutaneous mechanical circulatory support device with multiple balloons, which aims to solve the technical problems existing in the prior art.

[0005] The present application adopts the following technical solutions:

[0006] The present invention provides a multi-balloon percutaneous mechanical circulatory assist device, which includes a first balloon, a second balloon, a catheter and a tracheal assembly; the first balloon and the second balloon are arranged on the catheter in sequence from the distal end to the proximal end, the first balloon and the second balloon are connected to the external air supply system through the tracheal assembly, and the first balloon and the second balloon can be expanded or contracted simultaneously through the tracheal assembly; the outer diameter of the first balloon when expanded is greater than the outer diameter of the second balloon when expanded.

[0007] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the maximum expanded outer diameter of the first balloon is equal to 80%-90% of the inner diameter of the blood vessel.

[0008] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the tracheal assembly includes a first trachea and a second trachea; the first trachea has an inner diameter of D1 and is connected to the first balloon; the second trachea has an inner diameter of D2 and is connected to the second balloon; the D1 4 / D2 4 =V1 / V2, wherein V1 is the volume of the first balloon when it is fully expanded, and V2 is the volume of the second balloon when it is fully expanded.

[0009] The multi-balloon percutaneous mechanical circulatory assist device of the present invention also includes a third balloon and a third trachea; the third balloon is arranged on the catheter and is closer to the proximal end than the second balloon, the outer diameter of the third balloon when fully expanded is larger than the outer diameter of the second balloon when fully expanded, and the third balloon is at least used to block blood vessels when the second balloon and the first balloon are contracted; one end of the third trachea is connected to the third balloon, and the other end is connected to the external air supply system.

[0010] The multi-balloon percutaneous mechanical circulatory assist device of the present invention further includes a tracheal control component; the tracheal control component is used to control whether the first trachea in the tracheal assembly connected to the first balloon is conductive or not.

[0011] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the trachea assembly includes a flexible first trachea, a second trachea and a main trachea; one end of the first trachea is connected to the first balloon, and the other end is connected to the main trachea; one end of the second trachea is connected to the second balloon, and the other end is connected to the main trachea; the main trachea is connected to the external air supply system; the trachea control component controls whether the first trachea is conductive or not.

[0012] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the tracheal control part includes an outer tube, a movable part and a control part; one end of the movable part is located in the outer tube, and can rotate in the outer tube and / or move axially along the outer tube, and a guide groove is provided on the part of the movable part located in the outer tube; the guide groove is smaller than the groove, and the other end is located outside the outer tube; one end of the control part is located in the guide groove and is restricted in the guide groove, and can move along the guide groove when the movable part rotates in the outer tube and / or moves axially along the outer tube, so that the other end can extend or retract from the opening on the outer tube to squeeze or detach from the first trachea.

[0013] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the surface of the movable part on which the guide groove is provided is a conical surface; and the guide groove is a conical spiral structure provided along the surface of the movable part.

[0014] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the movable member is screwed to the outer tube.

[0015] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the control part includes a slider, a connecting part and an extrusion part; the slider is slidably arranged in the guide groove; one end of the connecting part is connected to the slider, and the other end is connected to the extrusion part, and the connecting part is gap-fitted with the opening.

[0016] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the surface of the extrusion member used to squeeze the first trachea is an arc-shaped surface, and its size is greater than or equal to the width of the first trachea when flattened, so as to completely block the first trachea during squeezing.

[0017] In the multi-balloon percutaneous mechanical circulatory assistance device of the present invention, the side of the connecting member connected to the extruding member extends in a direction perpendicular to the axial direction of the outer tube.

[0018] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the catheter passes through the first balloon and the second balloon and is sealed with the first balloon and the second balloon; the trachea assembly is arranged in the catheter and connects the first balloon and the second balloon through the inner wall of the catheter.

[0019] The multi-balloon percutaneous mechanical circulatory assist device of the present invention further includes a sheath; the sheath is sleeved on the catheter and can move along the catheter; the first balloon, the second balloon and the tracheal assembly can be accommodated inside the sheath after compression.

[0020] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, an identification structure is provided on the catheter; the identification structure is used to indicate whether the first balloon, the second balloon and the tracheal assembly are located inside or outside the sheath.

[0021] In the multi-balloon percutaneous mechanical circulatory assist device of the present invention, the volume of the first balloon when inflated is smaller than the volume of the second balloon when inflated.

[0022] The technical solution adopted by the present invention can achieve the following beneficial effects: the present invention mainly provides a multi-balloon percutaneous mechanical circulatory assist device, which is based on setting a first balloon on the distal side relative to the second balloon. In the first aspect, the first balloon and the second balloon expand or contract at the same time, then, a larger vacuum space can be formed during contraction, increasing the speed and amount of blood flowing into the body; in the second aspect, based on the addition of the first balloon, the swing of the second balloon during expansion and contraction can be reduced, and the impact of the distal end on the blood vessel wall can be reduced, thereby protecting the blood vessel wall; in the third aspect, based on the outer diameter of the first balloon when expanded is greater than the outer diameter of the second balloon when expanded, then when the second balloon expands, the first balloon can reduce blood reflux. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0024] Figure 1 This is a schematic structural diagram of a multi-balloon percutaneous mechanical circulatory assist device of the present invention;

[0025] Figure 2 This is a schematic structural diagram of a multi-balloon percutaneous mechanical circulatory assist device of the present invention when a third balloon is provided;

[0026] Figure 3 A schematic structural diagram of a multi-balloon percutaneous mechanical circulatory assist device in a contracted state according to the present invention;

[0027] Figure 4 and Figure 5 This is a state diagram of a multi-balloon percutaneous mechanical circulatory assist device of the present invention when used in Application Example 1;

[0028] Figure 6 and Figure 7 This is a state diagram of a multi-balloon percutaneous mechanical circulatory assist device of the present invention when used in Application Example 2;

[0029] Figure 8 and Figure 9A state diagram of a multi-balloon percutaneous mechanical circulation assisting device of the present application when used in application example 3;

[0030] Figure 10 A structural schematic diagram of an embodiment of the multi-balloon percutaneous mechanical circulation assisting device of the present application to realize the working state in application example 3;

[0031] Figure 11 A structural schematic diagram of the working state of the tracheal control member of the present application;

[0032] Figure 12 A structural schematic diagram of the tracheal control member of the present application;

[0033] Figure 13 A structural schematic diagram of the control member of the present application.

[0034] Explanation of reference signs:

[0035] 1. First balloon; 2. Second balloon; 3. Catheter; 4. Tracheal assembly; 41. First trachea; 42. Second trachea; 43. Total trachea; 5. Third balloon; 6. Third trachea; 7. Sheath tube; 8. Tracheal control member; 81. Outer tube; 811. Opening; 82. Movable member; 821. Guide groove; 83. Control member; 831. Slider; 832. Connecting member; 833. Extrusion member. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical scheme and advantages of the present application clearer, the technical scheme of the present application will be described below in combination with specific embodiments of the present application and corresponding drawings. In the description of the present application, it should be noted that the term “or” is generally used in the sense of including “and / or” unless the context clearly indicates otherwise.

[0037] In the description of the present application, it should be noted that unless otherwise explicitly specified and limited, the terms “mounting”, “connection” and “connection” should be understood broadly, for example, it can be fixed connection, or detachable connection, or integrally connected; it can be mechanical connection, or magnetic connection; it can be directly connected, or indirectly connected through an intermediate medium, or the communication inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances. In addition, in the description of the present application, the terms “first”, “second” and the like are only used for differentiation and description, and cannot be understood as indicating or implying relative importance. In the description of the present application, the meaning of “multiple” is at least two, for example, two, three or more, etc., unless otherwise explicitly specified and limited.

[0038] In the field of interventional medical device technology, the direction closest to the operator is generally defined as the proximal end, and the direction away from the operator is defined as the distal end. The direction of the central axis of objects such as cylinders and tubes is defined as the axial direction. The radial direction refers to the direction passing through the central axis in a radial plane, for example, along a straight line of diameter or radius, or perpendicular to the central axis.

[0039] Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0040] To solve the problems existing in the prior art, an embodiment of the present application provides a multi-balloon percutaneous mechanical circulatory assist device.

[0041] like Figure 1 As shown, a multi-balloon percutaneous mechanical circulatory assist device includes a first balloon 1, a second balloon 2, a catheter 3, and an endotracheal assembly 4. The first balloon 1 and the second balloon 2 are sequentially arranged on the catheter 3 from distal to proximal. The first balloon 1 and the second balloon 2 are connected to an external air supply system, such as an air pump, through the endotracheal assembly 4. The first balloon 1 and the second balloon 2 can be expanded or deflated simultaneously through the endotracheal assembly 4. The outer diameter of the inflated first balloon 1 is larger than the outer diameter of the inflated second balloon 2. The second balloon 2 has the same structure as the balloon in the IABP. Specifically, the main body of the second balloon 2 is a cylindrical structure; the first balloon 1 is a spherical structure. Preferably, the endotracheal assembly 4 is a flexible tube.

[0042] The present invention provides a multi-balloon percutaneous mechanical circulatory assist device, which is based on the arrangement of a first balloon 1 on the distal side relative to a second balloon 2. In the first aspect, the first balloon 1 and the second balloon 2 expand or contract at the same time, and thus, a larger vacuum space can be formed during contraction, thereby increasing the speed and amount of blood flowing into the body; in the second aspect, based on the addition of the first balloon 1, the swing of the second balloon 2 during expansion and contraction can be reduced, and the impact of the distal end on the blood vessel wall can be reduced, thereby protecting the blood vessel wall; in the third aspect, based on the outer diameter of the first balloon 1 when expanded is greater than the outer diameter of the second balloon 2 when expanded, the first balloon 1 can reduce blood reflux when the second balloon 2 expands.

[0043] In some preferred embodiments, the maximum expanded outer diameter of the first balloon 1 is equal to 80%-90% of the inner diameter of the blood vessel, such as 80%-90% of the inner diameter of the aorta; the expanded outer diameter of the first balloon 1 should not be too large, as it will severely impact the blood vessel wall, such as the aortic wall, and may even cause problems such as aortic dissection; nor should it be too small, as it will affect the amount of blood pumped and the pressure difference formed, thereby reducing the effect of preventing reflux. That is, adopting the above-mentioned size range can reduce the distal whipping effect and have a better effect of preventing blood reflux during expansion.

[0044] In some preferred embodiments, Figure 1 As shown, the tracheal assembly 4 includes a first tracheal tube 41 and a second tracheal tube 42; the first tracheal tube 41 has an inner diameter of D1 and is connected to the first balloon 1; the second tracheal tube 42 has an inner diameter of D2 and is connected to the second balloon 2; D1 4 / D2 4 =V1 / V2, where V1 is the volume of the first balloon 1 when fully expanded, and V2 is the volume of the second balloon 2 when fully expanded. Based on this definition, when supplied with air by a stable pressure source (such as an air pump) having the same pressure, the first balloon 1 and the second balloon 2 simultaneously expand from a contracted state to a fully expanded state, thereby increasing the pressure difference formed during contraction, improving the blood pumping speed, and ensuring that the real-time outer diameter of the first balloon 1 is larger than the outer diameter of the second balloon 2 during expansion, which is more conducive to preventing blood reflux. Preferably, the air pump is controlled by a cardiac pulsation detection signal from an external control device to ensure synchronization with the heartbeat. When the heart is in diastole, the trachea connecting the balloons 1 and 2 is inflated; when the heart is in systole, the trachea connecting the balloons 1 and 2 is deflated.

[0045] In some preferred embodiments, Figure 1 As shown, the catheter 3 passes through the first balloon 1 and the second balloon 2 and is sealed with the first balloon 1 and the second balloon 2; the tracheal assembly 4 is arranged in the catheter 3 and connects the first balloon 1 and the second balloon 2 through the inner wall of the catheter 3; based on this, the overall volume is reduced to facilitate the implantation operation.

[0046] In some preferred embodiments, Figure 1 As shown, it also includes a sheath 7; the sheath 7 is sleeved on the catheter 3 and can move along the catheter 3; the first balloon 1, the second balloon 2 and the tracheal assembly 4 can be accommodated inside the sheath 7 after compression; based on the setting of the sheath 7, the resistance is reduced during the intervention of the artery, and the surrounding structure of the balloon in the contracted state is prevented from being not smooth enough and scratching the blood vessel wall; preferably, the inner diameter of the sheath 7 is slightly smaller than the size of the first balloon 1 and the second balloon 2 in the contracted state, and when the sheath 7 is wrapped around the balloon, it has a certain interference fit, so that the sheath 7 is not easy to slide when wrapped around the balloon.

[0047] In some preferred embodiments, an identification structure (not shown) is provided on the catheter 3; the identification structure is used to indicate whether the first balloon 1, the second balloon 2, and the tracheal assembly 4 are located inside or outside the sheath 7. During intervention, the sheath 7 is wrapped around all balloons, with the distal end of the sheath 7 located outside the body. When the intervention position is reached, the external portion of the sheath 7 is manually pulled proximally until both the first balloon 1 and the second balloon 2 are exposed. The external portion of the catheter 3 has two identification structures, such as scales, which can indicate to the user whether the sheath 7 is completely wrapped around or completely uncovered when the sheath 7 is moved to the scale position.

[0048] In some preferred embodiments, the volume of the first balloon 1 when inflated is smaller than the volume of the second balloon 2 when inflated.

[0049] In some preferred embodiments, Figure 2 As shown, it also includes a third balloon 5 and a third trachea 6; the third balloon 5 is arranged on the catheter 3 and is closer to the proximal end than the second balloon 2. The outer diameter of the third balloon 5 when fully expanded is larger than the outer diameter of the second balloon 2 when fully expanded. The third balloon 5 is at least used to block blood vessels, such as blocking the aorta, when the second balloon 2 and the first balloon 1 are contracted; one end of the third trachea 6 is connected to the third balloon 5, and the other end is connected to the external air supply system, such as the external air supply system is an air pump; based on the addition of a balloon on the other side of the second balloon 2, the blood reflux on the side of the third balloon 5 can be reduced when the second balloon 2 and the first balloon 1 are contracted, and the blood inflow and blood pumping out during blood pumping can be increased; and based on the setting of the third balloon 5, the whipping effect can be further reduced.

[0050] Preferably, the expansion volume of the third balloon 5 is smaller than that of the second balloon 2 .

[0051] Preferably, the third trachea 6 is located inside the catheter 3 to facilitate implantation.

[0052] Preferably, the expanded volume of the third balloon 5 is equal to that of the first balloon 1 .

[0053] Preferably, the expanded outer diameter of the third balloon 5 is equal to that of the first balloon 1 .

[0054] Preferably, the third balloon 5 has the same shape as the first balloon 1 .

[0055] The following describes the usage of adding the third balloon 5 in combination with actual applications:

[0056] Application Example 1

[0057] When used for ventricular assist in acute or chronic heart failure, the assist device is placed in the descending aorta and when the heart is in the systolic phase of pumping blood, such as Figure 4As shown, the blood flow pumped from the left ventricle flows to the descending aorta, at this time, the distal first balloon 1 and the second balloon 2 are both contracted to form a blood flow passage, but the proximal third balloon 5 is inflated to cut off the blood flow to prevent the blood flow from the lower limb arteries from flowing back up; as shown, Figure 5 As shown, when the heart is in diastole, the distal first balloon 1 and the second balloon 2 are both inflated, and the proximal third balloon 5 is contracted, so that the blood originally around the first balloon 1 and the second balloon 2 is pumped downward to the whole body.

[0058] Application Example 2

[0059] When the patient has a heart surgery or myocardial infarction or any ischemia caused by ischemia, the auxiliary device can be placed at the abdominal artery, wherein the third balloon 5 is located at the lower part of the renal artery, and the second balloon 2 is located at the upper part of the renal artery; as shown, Figure 6 When the first balloon 1 and the second balloon 2 are contracted, the third balloon 5 is inflated to prevent the blood flow from the lower limbs from flowing back; the blood flow from the ventricle will flow more to the renal artery due to the cut-off of the third balloon 5, thereby increasing the renal and intestinal perfusion, as shown, Figure 7 When the first balloon 1 and the second balloon 2 are inflated, the third balloon 5 is contracted, and the blood is pumped to the renal artery and the lower limb femoral artery.

[0060] Application Example 3

[0061] When the auxiliary device is used in the vein or any pressurized direction opposite to the above-mentioned application example 1, the synchronization of the balloon inflation and contraction needs to be adjusted. Ideally, as shown, Figure 8 and Figure 9 The third balloon 5 and the second balloon 2 should be inflated and contracted synchronously, and the first balloon 1 is opposite. For example, when the heart stops, the blood is pumped from the descending aorta to the aortic arch and the left ventricle in reverse, when the aortic pressure reaches 180 mmhg, the blood supply of the coronary artery can be improved, and the probability of heart recovery can be improved. Therefore, when the device is used for ventricular assistance, if the heart stops, the reverse blood pumping mode can be adjusted to assist in rescue, and after the heart resumes beating, the original mode is adjusted to improve the cardiac output.

[0062] To achieve this working process, the following scheme can be adopted: by increasing the air pipe and the air pump, as shown, Figure 10 The first balloon 1, the second balloon 2 and the third balloon 5 are respectively connected to an air pump through an air pipe, that is, three air pumps are needed to realize the complete independence of the inflation and contraction of the first balloon 1, the second balloon 2 and the third balloon 5, but this working condition needs to control three air pumps, which increases the number of devices and the complexity of control.

[0063] In order to solve the problems existing in the above-mentioned application example 3, as shown, Figure 11As shown, the auxiliary device also includes a tracheal control component 8; the tracheal control component 8 is used to control whether the first trachea 41 connected to the first balloon 1 in the tracheal assembly 4 is conductive or not; based on the setting of the tracheal control component 8, it can adapt to working conditions with opposite pressures, that is, the third balloon 5 and the second balloon 2 are used in combination to achieve reverse control, and can be used in veins to increase the scope of application of the device.

[0064] Based on the setting of the tracheal control component 8, when encountering the working conditions in Application Example 3, dual air pump operation can be adopted, that is, the first balloon 1 and the second balloon 2 are expanded and contracted by one air pump, and the third balloon 5 is expanded and contracted by another air pump. When reverse pressurization is required, the first trachea 41 connected to the first balloon 1 can be manually blocked through the tracheal control component 8 when the first balloon 1 and the second balloon 2 are contracted, which is equivalent to abandoning the first balloon 1. At this time, the first balloon 1 is in a contracted state, and only the operating states of the second balloon 2 and the third balloon 5 are used, such as Figure 11 At this time, based on the setting of the third balloon 5, blood can also be prevented from being pumped to the left side of the third balloon 5 when the second balloon 2 is inflated, which plays a certain anti-reflux role and can reduce the number of air pumps used in the extracorporeal control equipment and the algorithm cost.

[0065] In some preferred embodiments, Figure 2 and Figure 11 As shown, the trachea assembly 4 includes a flexible first trachea 41, a second trachea 42 and a main trachea 43; one end of the first trachea 41 is connected to the first balloon 1, and the other end is connected to the main trachea 43; one end of the second trachea 42 is connected to the second balloon 2, and the other end is connected to the main trachea 43; the main trachea 43 is connected to the external air supply system; the trachea control component 8 controls whether the first trachea 41 is connected or not; based on the connection between the first trachea 41 and the second trachea 42 by the main trachea 43, the number of external air pumps is reduced, which facilitates the control during expansion and contraction, and cooperates with the trachea control component 8 to block the first trachea 41, so that it can be used for working conditions with opposite pressures; preferably, the first trachea 41 is a flexible tube.

[0066] In some preferred embodiments, Figure 12As shown, the tracheal control member 8 includes an outer tube 81, a movable member 82 and a control member 83; one end of the movable member 82 is located in the outer tube 81 and can rotate in the outer tube 81 and / or move axially along the outer tube 81, and a guide groove 821 is provided on the portion of the movable member 82 located in the outer tube 81, and the other end is located outside the outer tube 81 as an operating end; the notch of the guide groove 821 is smaller than the inner portion of the groove; one end of the control member 83 is located in the guide groove 821 and is confined in the guide groove 821 and can When the movable part 82 rotates in the outer tube 81 and / or moves axially along the outer tube 81, it can move along the guide groove 821, so that the other end can extend or retract from the opening 811 on the outer tube 81 to squeeze or detach from the first air pipe 41; based on this, the air pipe control part 8 can be extended into the adjacent position of the first air pipe 41, and then the movable part 82 is operated to be located at the end of the outer tube 81 to control the control part 83 to extend or retract, thereby realizing whether the first air pipe 41 is conductive or not.

[0067] Preferably, if Figure 11 As shown, the tracheal control component 8 and the tracheal assembly 4 are both located in the catheter 3 to reduce the overall volume, facilitate implantation, and facilitate the tracheal control component 8 to squeeze and block the first trachea 41 of the tracheal assembly 4.

[0068] In some preferred embodiments, Figure 12 As shown, the cross section of the guide groove 821 is a “convex” shape; the cross section of the end of the control member 83 is a “convex” shape adapted to the guide groove 821 to restrict the end of the control member 83 within the guide groove 821.

[0069] In some preferred embodiments, the guide groove 821 is arc-shaped, such as a spiral line. At this time, the movable part 82 rotates to make the control part 83 move along the guide groove 821, and along the extension direction of the guide groove 821, the radial distance between the guide groove 821 and the inner wall of the outer tube 81 gradually changes, so that when the control part 83 moves along the guide groove 821, it performs a telescopic movement relative to the opening 811. Alternatively, the guide groove 821 is arranged along the axial direction of the movable part 82, such as a straight groove or an arc-shaped groove, and along the extension direction of the guide groove 821, the radial distance between the guide groove 821 and the inner wall of the outer tube 81 gradually changes, and the telescopic movement of the movable part 82 relative to the outer tube 81 makes the control part 83 perform a telescopic movement relative to the opening 811 when it moves along the guide groove 821.

[0070] In some preferred embodiments, Figure 12 As shown, the surface of the movable part 82 on which the guide groove 821 is provided is a conical surface; the guide groove 821 is a conical spiral structure provided along the surface of the movable part 82; when the movable part 82 rotates, it rotates at the same angle, and the expansion and contraction amount of the control part 83 is consistent, which is more conducive to controlling the expansion and contraction amount.

[0071] In some preferred embodiments, the movable member 82 is screwed to the outer tube 81 ; the screw connection is conducive to maintaining a stable position and not easily causing axial movement, and is conducive to gradually adjusting the extension and contraction amount of the control member 83 .

[0072] In some preferred embodiments, Figure 12 and Figure 13 As shown, the control member 83 includes a slider 831, a connecting member 832 and an extrusion member 833; the slider 831 is slidably set in the guide groove 821; one end of the connecting member 832 is connected to the slider 831, and the other end is connected to the extrusion member 833, and the connecting member 832 is clearance-fitted with the opening 811; based on the clearance-fitting method, the opening 811 guides the extension and contraction direction of the control member 83 to prevent it from shaking, so that it is more stable during extrusion and blocking.

[0073] In some preferred embodiments, Figure 13 As shown, the surface of the extrusion piece 833 used to extrude the first air tube 41 is an arc-shaped surface, and its size is greater than or equal to the width of the first air tube 41 when flattened, so as to completely block the first air tube 41 during extrusion; preferably, the shape of the arc-shaped surface is adapted to the first air tube 41, and more preferably, when the first air tube 41 is located in the conduit 3, the shape of the arc-shaped surface is adapted to and fits the inner wall of the conduit 3.

[0074] In some preferred embodiments, Figure 12 As shown, one side of the connecting piece 832 connected to the extrusion piece 833 extends in a direction perpendicular to the axial direction of the outer tube 81; based on this, the expansion and contraction are made faster.

[0075] Specifically, the connecting piece 832 is a bent structure, and one side of the connecting piece 833 is perpendicular to the axial direction of the outer tube 81 .

[0076] In some preferred embodiments, Figure 12 As shown, the end of the connecting member 832 is in contact with the surface of the movable member 82 , further improving the stability of the control member 83 when it moves.

[0077] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims

1. A multi-balloon percutaneous mechanical circulatory assist device, characterized in that: The device comprises a first balloon, a second balloon, a catheter and a tracheal assembly; The first balloon and the second balloon are sequentially arranged on the catheter in a direction from the distal end to the proximal end, the first balloon and the second balloon are connected to an external air supply system through the tracheal assembly, and the first balloon and the second balloon can be expanded or deflated simultaneously through the tracheal assembly; The outer diameter of the first balloon when inflated is greater than the outer diameter of the second balloon when inflated.

2. The multi-balloon percutaneous mechanical circulatory assist device according to claim 1, characterized in that: The maximum expanded outer diameter of the first balloon is equal to 80%-90% of the inner diameter of the blood vessel.

3. The multi-balloon percutaneous mechanical circulatory assist device according to claim 1, characterized in that: The trachea assembly includes a first trachea and a second trachea; The first trachea has an inner diameter of D1 and is connected to the first balloon; The second trachea has an inner diameter of D2 and is connected to the second balloon; D1 4 / D2 4 =V1 / V2, wherein V1 is the volume of the first balloon when it is fully expanded, and V2 is the volume of the second balloon when it is fully expanded.

4. The multi-balloon percutaneous mechanical circulatory assist device according to claim 1, characterized in that: Also included is a third balloon and a third trachea; The third balloon is disposed on the catheter and is closer to the proximal end than the second balloon. The outer diameter of the third balloon when fully inflated is larger than the outer diameter of the second balloon when fully inflated. The third balloon is at least used to occlude a blood vessel when the second balloon and the first balloon are deflated. One end of the third trachea is connected to the third balloon, and the other end is connected to the external air supply system.

5. The multi-balloon percutaneous mechanical circulatory assist device according to claim 4, characterized in that: Also included are airway controls; The trachea control component is used to control whether the first trachea in the trachea assembly connected to the first balloon is conductive or not.

6. The multi-balloon percutaneous mechanical circulatory assist device according to claim 5, characterized in that: The trachea assembly includes a flexible first trachea, a second trachea and a main trachea; One end of the first trachea is connected to the first balloon, and the other end is connected to the main trachea; One end of the second trachea is connected to the second balloon, and the other end is connected to the main trachea; The main gas pipe is connected to the external gas supply system; The airway control component controls whether the first airway is connected or not.

7. The multi-balloon percutaneous mechanical circulatory assist device according to claim 5 or 6, characterized in that: The trachea control component includes an outer tube, a movable component and a control component; One end of the movable member is located inside the outer tube and is capable of rotating inside the outer tube and / or moving axially along the outer tube, and a guide groove is provided on the portion of the movable member located inside the outer tube; the notch of the guide groove is smaller than the inner portion of the groove, and the other end is located outside the outer tube; One end of the control member is located in the guide groove and is confined in the guide groove, and can move along the guide groove when the movable member rotates in the outer tube and / or moves axially along the outer tube, so that the other end can extend or retract from the opening on the outer tube to squeeze or detach from the first air pipe.

8. The multi-balloon percutaneous mechanical circulatory assist device according to claim 7, characterized in that: The surface of the movable part on which the guide groove is arranged is a conical surface; and the guide groove is a conical spiral structure arranged along the surface of the movable part.

9. The multi-balloon percutaneous mechanical circulatory assist device according to claim 7, characterized in that: The movable member is screwed to the outer tube.

10. The multi-balloon percutaneous mechanical circulatory assist device according to claim 7, characterized in that: The control member includes a slider, a connecting member and an extruding member; The slider is slidably arranged in the guide groove; One end of the connecting member is connected to the slider, and the other end is connected to the extrusion member, and the connecting member is gap-matched with the opening.

11. The multi-balloon percutaneous mechanical circulatory assist device according to claim 10, characterized in that: The surface of the extrusion piece used to extrude the first air tube is an arc-shaped surface, and its size is greater than or equal to the width of the first air tube when it is flattened, so as to completely block the first air tube during extrusion.

12. The multi-balloon percutaneous mechanical circulatory assist device according to claim 10, characterized in that: A side of the connecting piece connected to the extrusion piece extends in a direction perpendicular to the axial direction of the outer tube.

13. The multi-balloon percutaneous mechanical circulatory assist device according to any one of claims 1 to 12, characterized in that: The catheter passes through the first balloon and the second balloon and is sealedly connected to the first balloon and the second balloon; The tracheal assembly is arranged in the catheter, and the first balloon and the second balloon are connected through the inner wall of the catheter.

14. The multi-balloon percutaneous mechanical circulatory assist device according to any one of claims 1 to 12, characterized in that: Also included is a sheath; The sheath is sleeved on the catheter and can move along the catheter; The first balloon, the second balloon and the tracheal assembly can be accommodated inside the sheath tube after being compressed.

15. The multi-balloon percutaneous mechanical circulatory assist device according to claim 14, characterized in that: The catheter is provided with an identification structure; The identification structure is used to indicate whether the first balloon, the second balloon, and the tracheal assembly are located inside or outside the sheath.

16. The multi-balloon percutaneous mechanical circulatory assist device according to any one of claims 1 to 12, characterized in that: The volume of the first balloon when inflated is smaller than the volume of the second balloon when inflated.

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