Catheter device for circulation assistance and circulation assistance system

Abstract

The invention discloses a catheter device for circulation assistance and a circulation assistance system. The catheter device comprises a catheter body, a far-end one-way valve and a near-end one-way valve which are distributed at intervals are arranged on the catheter body, the far-end one-way valve is closer to the tail end of the catheter body than the near-end one-way valve, and the rotating opening and closing directions of valve blades of the far-end one-way valve and the near-end one-way valve are opposite; in a suction state, valve blades of the far-end one-way valve and the near-end one-way valve are driven by negative pressure in the catheter body to inwards close a flow channel, so that a valve port of the near-end one-way valve is communicated with an inner cavity of the catheter body to form a suction channel; in the liquid injection state, the valve leaves of the far-end one-way valve and the near-end one-way valve are driven by positive pressure in the catheter body to outwards close valve ports of the valve leaves and open flow channels of the valve leaves, and the catheter body is made to be through in the injection direction. Through the design of the integrated catheter structure and the double-valve structure, the double-valve structure of the ventricle and the active ejection process are simulated, electrocardio gating triggering is not needed, and implantation operation and use are easy.

Description

Technical Field

[0001] The invention relates to a catheter device and a circulation assistance system for circulation assistance, belonging to the technical field of medical devices. Background Art

[0002] Mechanical circulatory support (MCS) is a life support technology and an important "bridge" treatment for patients with acute cardiac events and end-stage heart failure (HF).

[0003] Percutaneous mechanical circulatory support (pMCS) is one of the important technologies in circulatory support (MCS). Unlike the classic long-term implantable circulatory support technology, which is mostly used for transplantation transition or terminal treatment of heart failure, pMCS is mostly used for short-term circulatory support. At present, pMCS is mainly used for high-risk peronary coronary intervention (HRPCI) and emergency treatment of cardiogenic shock (CS). Classic short-term percutaneous circulatory support methods mainly include intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO), Extra-VAD with pump located outside the body, and pVAD with pump located inside the body.

[0004] Among them, IABP is simple, quick and cheap to insert. But its disadvantage is that it can only provide less hemodynamic support and myocardial protection; ECMO and Extra-VAD have greater flow support than IABP and better hemodynamic effect, but the risk of complications and the difficulty of management are high, and the cost is very high; pVAD is mostly a percutaneous axial flow pump, minimally invasively inserted, with large flow but high speed resulting in complications such as hemolysis and microparticles.

[0005] In addition, the above commonly used percutaneous mechanical circulatory assist devices are mainly used for acute left heart failure, and the insertion route is mainly peripheral large arteries (femoral artery / axillary artery / subclavian artery). There are shortcomings such as complications of arterial puncture and catheterization (hematoma, dissection, pseudoaneurysm, arteriovenous fistula, etc.) and limited caliber (causing lower limb artery ischemia).

[0006] Existing pMCS devices are mainly used to assist cardiac blood circulation, and each has certain defects. Therefore, it is necessary to develop a circulation device that can be applied to different disease areas that require blood supply reconstruction (including left heart failure, right heart failure, acute renal failure, etc.), which can actively generate pulsed blood flow similar to physiological and adjustable flow, reduce complications such as hemolysis to a certain extent, and is easy to operate. Summary of the invention

[0007] The purpose of the present invention is: in view of the deficiencies in the prior art, the present invention provides a catheter device and a circulatory assistance system for circulatory assistance. The catheter device is provided with two one-way valves with opposite opening and closing directions, and uses the pressure difference inside the catheter body to control the opening and closing states of the two valves, thereby realizing the functions of blood suction and pumping; the present invention simulates the double valve structure and active ejection process of the ventricle through the design of an integrated catheter structure + a double valve structure, does not require ECG gating triggering, and is easy to insert, operate and use.

[0008] In order to achieve the above-mentioned object, the present invention provides a catheter device for circulation assistance, comprising a catheter body, on which a distal one-way valve and a proximal one-way valve are arranged at intervals, wherein the distal one-way valve and the proximal one-way valve both have an outward valve port and a valve leaf driven by the pressure change inside the catheter body to rotate to open and close the valve port / flow channel thereof, and the valve leaf is rotatably connected to the flow channel of the one-way valve, and the valve leaves of the distal one-way valve and the proximal one-way valve rotate in opposite directions of opening and closing;

[0009] The catheter device has a suction state and a liquid injection state. In the suction state, the valve leaf of the distal one-way valve and the valve leaf of the proximal one-way valve are driven inward by the negative pressure in the catheter body to close the flow channel, so that the valve port of the proximal one-way valve is connected with the inner cavity of the catheter body to form a suction channel;

[0010] In the injection state, the positive pressure in the catheter body drives the valve leaves of the distal one-way valve and the valve leaves of the proximal one-way valve to close their valve ports outward and open their flow channels, so that the catheter body can pass through in the injection direction.

[0011] Furthermore, the spacing distance between the distal one-way valve and the proximal one-way valve can be customized and adjusted according to different access methods and indications.

[0012] Furthermore, the valve leaves of the distal one-way valve and the proximal one-way valve are of an arc surface structure as a whole, and the two valve leaves are distributed on the same side of the catheter body and are symmetrically wing-shaped; the valve leaves are rotatably connected to the flow channel of the one-way valve through a rotating shaft and the center of mass of the valve leaves is arranged on the side close to the rotating shaft, so that the valve leaves can be easily flipped.

[0013] Furthermore, the valve openings of the distal one-way valve and the proximal one-way valve may be arc-shaped structures and / or other shapes, and their axial projection areas are smaller than the projection areas of the valve leaves. When the valve leaves are opened, the valve leaves can completely close the valve openings to prevent blood leakage.

[0014] Furthermore, the proximal one-way valve is configured so that when the flow channel is closed, a gap is left between the valve leaf and the inner wall of the flow channel; the distal one-way valve is configured so that when the flow channel is closed, the valve leaf and the inner wall of the flow channel are in contact and sealed.

[0015] Furthermore, it also includes a distal outlet nozzle detachably connected to the end of the catheter body, the distal outlet nozzle is set as a cylindrical shell structure and is coaxial with the catheter body. The distal outlet nozzle is provided with a plurality of through holes connected to the inner cavity of the catheter body.

[0016] Furthermore, the through hole of the distal outlet nozzle is divided into a plurality of side openings evenly distributed around the central axis of the distal outlet nozzle, and a central opening penetrating along the axial direction of the distal outlet nozzle.

[0017] Furthermore, the side opening is a strip-shaped hole structure and is parallel to the axial direction of the distal outlet nozzle.

[0018] Furthermore, the catheter body includes a first distal tube segment, a second distal tube segment and a proximal catheter segment, the two ends of the first distal tube segment are respectively connected to the distal outlet nozzle and the distal one-way valve, the two ends of the second distal tube segment are respectively connected to the distal one-way valve and the proximal one-way valve, and one end of the proximal catheter segment is connected to the proximal one-way valve.

[0019] Furthermore, the first distal tube segment, the second distal tube segment and the proximal catheter segment are respectively a multi-layer composite structure, which includes at least an outer layer, an inner layer and an intermediate layer, wherein the materials of the inner layer and the outer layer are both polymer materials, and the intermediate layer is a metal braided layer, a spring-wound layer or a combination of a metal braided structure and a spring structure; the inner and outer surfaces of the catheter are coated with an anti-coagulation coating, and the catheter with the multi-layer composite structure has good flexibility, folding resistance, support, and torsion resistance, and can withstand a suction force of up to 300kPa without collapsing.

[0020] Furthermore, it also includes a pump body communicated with the catheter body.

[0021] Furthermore, the pump body is a diaphragm pump, and the diaphragm pump includes a blood chamber and a driving liquid chamber separated by a flexible membrane.

[0022] Furthermore, a pressure sensor is provided on the distal one-way valve and / or the proximal one-way valve.

[0023] The present invention also provides the use of the above-mentioned catheter device in preparing products for treating acute heart failure, acute kidney injury (AKI), cardiorenal syndrome (CRS) or products for circulation assistance in renal failure.

[0024] The present invention also provides a circulation auxiliary system, including a host computer control system and the above-mentioned catheter device, the catheter device also including a pump body connected to the catheter body, the host computer control system includes a host computer and a liquid drive system for driving the pump body to fill and discharge liquid, the host computer is communicatively connected to the liquid drive system, and is used to monitor and manage the operation and opening and closing of the liquid drive system.

[0025] Furthermore, the liquid drive system includes a liquid drive device and a motor, and the pump body is connected to the liquid drive device and the motor in sequence.

[0026] Furthermore, the pump body is a diaphragm pump, and the host computer control system also includes an ECG signal recognition module, which (via communication connection with the ECG detection system) can recognize ECG signals. The host computer control system is configured to control the liquid drive system to fill or discharge the drive liquid chamber of the diaphragm pump through the recognized ECG signals, thereby achieving synchronization with the natural rhythm of the patient's cardiac cycle.

[0027] Furthermore, a parallel working circuit is provided on the working pipeline connecting the diaphragm pump and the catheter body, and an oxygenator module and / or a dialysis module and / or a heat exchange module are connected to the parallel working circuit to realize the functions of artificial lung and / or kidney replacement and / or regulating the temperature of circulating blood entering the body.

[0028] Furthermore, the host computer system includes a pressure identification module, and a pressure sensor is provided on the distal one-way valve and / or the proximal one-way valve. The pressure identification module is electrically connected to the pressure sensor and the liquid drive system respectively, and the pressure signal detected by the pressure sensor is fed back to the pressure identification module. The host computer control system is configured to dynamically control the frequency and flow rate of filling or discharging liquid from the driving liquid chamber of the diaphragm pump by the liquid drive system through the pressure signal; that is, the pressure sensor and the pressure control module are configured to determine whether the patient's left ventricle is in a contraction or relaxation state or to determine the pressure state of other physiological positions (except the left ventricle) of the two valves based on the pressure data, thereby dynamically controlling the liquid drive system to fill or discharge liquid from the driving liquid chamber of the diaphragm pump.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] 1. The present invention realizes the functions of blood suction and pumping by respectively arranging one-way valves with opposite opening and closing directions at the proximal and distal ends of the catheter, and controlling the opening and closing states of the two valves by using the pressure difference inside the catheter body. At the moment of suction, the pump body forms a negative pressure inside the catheter body, and the instantaneous pressure outside the proximal one-way valve and the distal one-way valve is greater than the internal pressure, driving the valve leaves of both to rotate inward at the same time, thereby realizing valve closure, and blood cannot pass through the distal valve; at the same time, the valve port of the proximal one-way valve is opened, and blood enters the pump body from the valve port position of the proximal one-way valve;

[0031] 2. The catheter device of the present invention is driven by hydraulic pressure and does not rely on ECG triggering. The suction and pumping frequencies are adjusted by adjusting the frequency of the driving motor. When the single blood pumping volume is constant, the faster the frequency, the greater the flow rate. According to the needs of the patient, the frequency can be set at 30-100 times / Min. The catheter device of the present invention can be used for other auxiliary circulations such as renal circulation and pulmonary circulation and the treatment of various diseases requiring blood supply reconstruction. The distance between the distal check valve and the proximal check valve can be adjusted according to different needs, so as to realize the pumping of blood from one position to another. It can not only achieve local pressure reduction and increase, but also assist the heart to pump blood and increase the perfusion of various tissues and organs. It can be used to treat diseases such as acute right heart failure, left heart failure, and acute renal failure.

[0032] 3. At the moment of blood injection into the pump body, the blood quickly passes through the inside of the catheter body, and when passing through the proximal one-way valve, it enters below the proximal valve leaf through the gap between the proximal valve leaf and the inner wall of the flow channel. The pressure of the blood entering below on the inner surface of the proximal one-way valve is greater than the pressure of the blood on the outer surface of the proximal valve leaf, thereby driving the proximal valve leaf to rotate upward, so that the flow channel of the proximal one-way valve is opened and the valve port is closed. The distal valve leaf of the distal one-way valve is also pushed open by the blood, and the blood is discharged from the through hole of the distal outlet nozzle;

[0033] 4. The catheter device of the present invention can generate pulsatile blood flow, which avoids the inherent disadvantage of continuous high-speed blood flow that is prone to high mechanical shear stress, thereby greatly reducing the occurrence of hemolysis;

[0034] 5. The catheter device of the present invention has a simple structure and a simple implantation method, and can be inserted through a venous route, thus avoiding the related complications caused by arterial route insertion. At the same time, a thicker catheter (<30F) can be inserted compared to the arterial route, thereby obtaining a larger output flow and a lower blood flow velocity. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a schematic diagram of the overall structure of the catheter device of the present invention.

[0036] Figure 2 for Figure 1 Enlarged view of part A in .

[0037] Figure 3 for Figure 1 Enlarged view of part B in .

[0038] Figure 4 Schematic diagram of catheter blood drawing.

[0039] Figure 5 Schematic diagram of catheter blood injection.

[0040] Figure 6 It is a partial schematic diagram of the gap h between the proximal one-way valve leaf and the catheter wall.

[0041] Figure 7 Schematic diagram of the three-dimensional structure of the distal outlet nozzle.

[0042] Figure 8 Schematic diagram of the principle of opening the valve leaf of the proximal one-way valve during blood injection: follow the process shown in (a)-(c).

[0043] Fig. 9 This is a preferred application example diagram of the present invention.

[0044] Fig.10 Schematic diagram of three control modes of the liquid drive device; among them: a is continuous suction and filling without feedback; b is when used for ventricular assist, by collecting ECG signals, keeping synchronization with the natural rhythm of the patient's cardiac cycle, and realizing suction and pumping actions synchronized with the heart; c is by collecting pressure signals on the catheter, judging the heart beat frequency, and realizing suction and blood pumping actions synchronized with the heart; or judging the pressure state of other physiological positions of the two valves, so as to dynamically adjust the driving frequency and flow as needed.

[0045] Fig.11 This is a schematic diagram of the usage status of the left heart assist circulatory system provided in Example 2 after being implanted via the intravenous route.

[0046] Fig.12 This is a schematic diagram of the usage status of the left heart assist circulation system provided in Example 2 after percutaneous apical puncture path placement.

[0047] Fig.13 This is a schematic diagram of the usage status of the right heart assist circulatory system provided in Example 2.

[0048] Fig.14 This is a schematic diagram of the use status of the dual-heart auxiliary circulation system provided in Example 2.

[0049] Fig.15 This is a schematic diagram of the usage status of the AKI auxiliary circulation system provided in Example 3.

[0050] Fig.16 This is a schematic diagram of connecting the oxygenator module in Example 4 to realize an artificial lung.

[0051] Figure markings: 1-distal outlet nozzle; 1a-side opening; 1b-central opening; 2-first distal tube section; 3-distal one-way valve; 3a-distal valve leaf; 3b-distal flow port; 3c-distal valve seat; 4-second distal tube section; 5-proximal one-way valve; 5a-proximal valve leaf; 5b-proximal flow port; 5c-proximal valve seat; 6-proximal catheter section; 7-pump body; 7a-blood chamber; 7b-flexible diaphragm; 7c-driving liquid chamber; 8. Liquid driving device; 9. Motor; 10. Host computer; 11. ECG control line; 12. Pressure control line; 13. Oxygenation / ultrafiltration module. DETAILED DESCRIPTION

[0052] In order to make the present invention more clearly understood, preferred embodiments are described in detail below with reference to the accompanying drawings.

[0053] Example 1

[0054] This embodiment provides a catheter device for circulatory assistance, such as Figure 1 As shown, it includes a catheter body that is inserted into human tissue when in use. The catheter body is connected with the pump body 7 when working. A distal one-way valve 3 and a proximal one-way valve 5 are provided on the catheter body. One end of the catheter body is the terminal end, which is set as an open structure, and the other end is used to connect with the pump body 7. The distal one-way valve 3 and the proximal one-way valve 5 on the catheter body have an outward valve port and a valve leaf that is driven by the pressure change inside the catheter body to rotate to open and close its valve port / flow channel, and the valve leaf is rotatably connected to the flow channel of the one-way valve; the valve seat of the distal one-way valve 3 and the proximal one-way valve 5 is a circular tubular structure, and both ends are sealed and connected to the catheter body and keep coaxial with the catheter body. The valve port is opened on the side wall of the valve seat, and the flow channel is the inner cavity of the valve seat. The valve leaf is rotatably connected to the inner wall of the flow channel. The valve leaf can close the valve port by rotating outward so that the flow channel is connected with the inner cavity of the catheter body, and can close the flow channel by rotating inward so that the valve port is opened.

[0055] The pump body 7 may be a diaphragm pump, which includes a blood chamber 7a and a driving liquid chamber 7c separated by a flexible diaphragm 7b. Figure 4 As shown; the present invention may also use other types of positive displacement pumps, which are not limited here.

[0056] The distal one-way valve 3 and the proximal one-way valve 5 have the same structural composition, but the difference is that the rotation opening and closing directions of their valve leaves are opposite.

[0057] like Figure 2 As shown, the distal one-way valve 3 includes a tubular distal valve seat 3c and a distal valve leaf 3a rotatably connected to the inner cavity of the distal valve seat 3c. The distal valve seat 3c is provided with a distal flow port 3b as a valve port, and the interior of the distal valve seat 3c is set as a flow channel of the distal one-way valve 3.

[0058] like Figure 3As shown, the proximal one-way valve 5 includes a tubular proximal valve seat 5c and a proximal valve leaf 5a rotatably connected to the proximal valve seat 5c. The proximal valve seat 5c is provided with a proximal flow port 5b as a valve port, and the interior of the proximal valve seat 5c is set as a flow channel of the proximal valve seat 5c.

[0059] The above-mentioned distal one-way valve 3 and proximal one-way valve 5 are spaced apart along the length direction of the catheter body, and the distal one-way valve 3 is closer to the end of the catheter body than the proximal one-way valve 5, and the valve leaf of the distal one-way valve 3 and the valve leaf of the proximal one-way valve 5 have opposite rotation opening and closing directions.

[0060] like Figure 4 As shown, when the pump body 7 is in the suction state (drawing blood), the valve leaves of the distal one-way valve 3 (distal valve leaf 3a) and the valve leaves of the proximal one-way valve 5 (proximal valve leaf 5a) are driven by the negative pressure in the catheter body to close the flow channel inward, so that the valve port of the proximal one-way valve 5 is connected with the inner cavity of the catheter body to form a suction channel, so that the blood in the human body flows into the catheter body through the valve port of the proximal one-way valve 5 (proximal flow port 5b) and flows to the pump body 7; at this time, the role of the distal one-way valve 3 is: when the pump body 7 is suctioning, since the internal flow channel of the distal one-way valve 3 is closed, blood is prevented from entering the catheter from the end, thereby achieving an auxiliary sealing effect.

[0061] like Figure 5 As shown, in the injection state (blood injection), the positive pressure in the catheter body drives the valve leaves of the distal one-way valve 3 and the proximal one-way valve 5 to close their valve ports outward and open their flow channels to allow the catheter body to pass through, so that blood is pumped from the end of the catheter into the corresponding position in the body.

[0062] In short, the present invention can draw blood from the position of the proximal one-way valve 5 through the suction effect of the pump body 7; when pumping blood into the human body, the distal one-way valve 3 and the proximal one-way valve 5 are opened at the same time, so that the entire catheter body is connected and blood is pumped out at the end of the catheter body.

[0063] The key structural design of the above scheme is that when the proximal one-way valve 5 closes the flow channel, a gap h (such as 0.1mm-2mm and other parameters can be set according to the situation) is left between the valve leaf and the inner wall of the flow channel. Figure 6 As shown; when the distal one-way valve 3 closes the flow channel, the valve leaf and the inner wall of the flow channel are in contact and sealed without leaving any gap, thereby achieving the best sealing effect when drawing blood.

[0064] like Figure 7 As shown, the catheter device also includes a distal outlet nozzle 1 detachably connected to the end of the catheter body. The distal outlet nozzle 1 is set as a cylindrical shell structure and is coaxial with the catheter body. The distal outlet nozzle 1 is provided with a plurality of through holes connected to the inner cavity of the catheter body.

[0065] The through hole of the distal outlet nozzle 1 is divided into a plurality of side openings 1 a evenly distributed around the central axis of the distal outlet nozzle 1 , and a central opening 1 b penetrating along the axial direction of the distal outlet nozzle 1 .

[0066] The side opening 1 a is a strip-shaped hole structure and is parallel to the axial direction of the distal outlet nozzle 1 .

[0067] The side opening 1a provided at the distal outlet nozzle 1 can reduce the reverse impact generated when the blood is pumped out, maintain the stability of the catheter, and also prevent the blood vessels from being damaged due to excessive unidirectional blood flow velocity.

[0068] The central opening 1b is designed to pass a guidewire catheter during interventional surgery to facilitate delivery of the catheter to a target location.

[0069] like Figure 4-5 As shown, the working principle and process of the catheter device of the present invention are: at the moment of suction, the pump body 7 forms a negative pressure in the catheter body, and the instantaneous pressure outside the proximal one-way valve 3 and the distal one-way valve 5 is greater than the internal pressure, driving the valve leaves of both to rotate inward at the same time, thereby achieving valve closure, the valve port of the proximal valve port 3 (distal flow port 3b) is opened, and blood enters the pump body 7 from the valve port position of the proximal one-way valve 3.

[0070] like Figure 8 As shown in FIG. 1 , at the moment of pumping blood by the pump body 7, blood quickly passes through the inside of the catheter body, and when passing through the proximal one-way valve 5, blood enters below the proximal valve leaf 5a through the gap between the proximal valve leaf 5a and the inner wall of the flow channel. According to the Bernoulli principle, the pipe diameter at the valve leaf gap h suddenly becomes smaller, the instantaneous flow rate increases, and the fluid becomes a vortex, so that the instantaneous pressure Pinside on the inner surface of the valve leaf 5a is greater than the pressure Poutside on the outer surface, thereby driving the proximal valve leaf 5a to rotate upward, as shown in FIG. Figure 8 As shown in (a), the valve leaf opening process is as follows Figure 8 As shown in (b), the flow passage of the proximal one-way valve 5 is opened and the valve port (proximal flow port 5b) is closed. Figure 8 (c) As shown; at the same time, the distal valve leaf 3a of the distal one-way valve 3 is also pushed open by the blood, and the blood is discharged from the through hole of the distal outlet nozzle 1.

[0071] As one of the structural optimization solutions, Figure 1 As shown, for the convenience of connection, the above-mentioned catheter body includes a first distal tube segment 2, a second distal tube segment 4 and a proximal catheter segment 6, the two ends of the first distal tube segment 2 are respectively connected to the distal outlet nozzle 1 and the distal one-way valve 3, the two ends of the second distal tube segment 4 are respectively connected to the distal one-way valve 3 and the proximal one-way valve 5, and one end of the proximal catheter segment 6 is connected to the proximal one-way valve 5 and the other end is connected to the pump body 7.

[0072] In this embodiment, the catheter body is an elastic catheter with a multi-layer composite structure:

[0073] The catheter comprises at least an inner layer, an outer layer and a middle layer, wherein the inner layer and the outer layer are both made of polymer materials, giving the catheter good flexibility and sealing properties, and the middle layer is a spring structure, a metal braided structure, or a combination of a spring structure and a braided structure, giving the catheter good elasticity and deformation resistance; the catheter of the multi-layer composite structure has good flexibility, folding resistance, support, and torsion resistance, and can withstand a suction force of up to 300kPa without collapse.

[0074] Furthermore, the inner and outer surfaces of the catheter body are coated with an anticoagulant coating, which can effectively inhibit the formation of thrombus on the catheter surface.

[0075] The catheter can be equipped with a variety of calibers and is particularly suitable for interventional cardiac assistance in children or small patients.

[0076] When the catheter device of the present invention is in use, the catheter device is connected to the pump body 7, and the pump body 7 is connected to the liquid drive device 8 and the motor 9 in sequence. Fig. 9 shown.

[0077] In the present invention, there are three control modes for the liquid drive device: 1. Continuous suction and filling without feedback ( Fig.10 a). 2. Electrically connect the ECG detection system through the ECG control line 11 to collect ECG signals, keep synchronization with the natural rhythm of the patient's cardiac cycle, and achieve suction and pumping actions synchronized with the heart ( Fig.10 b). 3. Electrically connect the pressure sensor through the pressure control line 12 to collect the pressure signal on the catheter, determine the heart beat frequency, and achieve the suction and blood pumping action synchronized with the heart; or determine the pressure state of other physiological positions of the two valves, so as to dynamically adjust the driving frequency and flow according to the needs of the disease ( Fig.10 c).

[0078] In the present invention, the working pump is a volumetric pump, preferably a diaphragm pump, and the appropriate output capacity ("Cardiac Output") can be obtained in a wide range by adjusting the working frequency ("Heart Rate") and the motor stroke ("Stroke Volume"); and the output efficiency is high, and "what you see is what you get" (the driving liquid chamber of the diaphragm pump can visually observe the amount of blood pumped each time).

[0079] Among them, the inner surface of the blood cavity of the pump body is coated with an anticoagulant coating, which can effectively reduce the incidence of blood coagulation in the blood cavity.

[0080] The catheter device of the present invention is driven by a liquid medium. Compared with a gas medium drive, due to the incompressibility of the liquid, the energy transfer efficiency is higher, the response is faster, and the adverse events of gas embolism caused by diaphragm rupture are avoided from the source;

[0081] In addition, liquid has a higher specific heat capacity. By heating the liquid driving medium (temperature control and heat exchange module), the blood in the pump can be heated, thereby avoiding the decrease in core body temperature caused by the blood running outside the body.

[0082] Example 2

[0083] This embodiment provides a circulatory assist system for left ventricular assist, such as Fig.11 As shown, it includes a catheter, a diaphragm pump 7 connected to the catheter, a liquid drive system and a host computer 10. The drive liquid in the diaphragm pump drive liquid chamber can be physiological saline. The liquid drive system is used to control the filling and discharge of the diaphragm pump drive liquid chamber. The catheter can be percutaneously inserted into the body through the inferior vena cava-atrial septum-left atrium-mitral valve-left ventricle-left ventricular outflow tract-ascending aorta (across the aortic valve) path (path 1), and its distal blood outlet is located in the ascending aorta (on the aortic valve), and the proximal blood inlet is located in the left ventricle / left atrium. The diaphragm pump 7 connected to the catheter is placed outside the body, and the drive liquid chamber of the diaphragm pump is connected to the liquid drive system at the rear end. Start the liquid drive system. When the diaphragm pump drives the liquid chamber to discharge the liquid, the proximal one-way valve 5 located in the left atrium / left ventricle opens, and the catheter draws blood from the left atrium / left ventricle into the blood chamber of the diaphragm pump. When the diaphragm pump drives the liquid chamber to fill the liquid, the distal one-way valve 3 (blood outlet one-way valve) located in the ascending aorta opens, and the blood is discharged to the ascending aorta through the distal outlet nozzle 1. In this cycle, the catheter can transport the blood from the left atrium / left ventricle to the ascending pulmonary aorta through the diaphragm pump, thereby unloading the left ventricle and playing a left heart assist role.

[0084] The catheter can also be placed into the ascending aorta via the apical puncture route (path 2), with the distal blood outlet located in the ascending aorta (on the aortic valve), the proximal blood inlet located in the left ventricle, and the driving fluid chamber of the diaphragm pump connected to the rear end of the liquid drive device. Fig.12 shown.

[0085] This embodiment also provides a circulatory assist system for right heart assist, such as Fig.13 shown.

[0086] This embodiment also provides a circulatory assistance system for dual heart assistance, such as Fig.14 shown.

[0087] The catheter can be inserted through the venous route, and different insertion routes can be used to achieve different left and right heart assistance effects, while avoiding the serious complications of the arterial route and retaining the arterial route for cardiac intervention.

[0088] In addition, the larger diameter of the vein can tolerate a larger diameter catheter (<30F), thereby increasing the flow rate of the pump and simultaneously reducing the blood flow rate and fluid shear force, thereby reducing the destruction of blood components and facilitating long-term assistance.

[0089] Example 3

[0090] This embodiment provides a circulatory assist system for treating acute kidney injury (AKI), such as Fig.15 As shown, the proximal one-way valve (inlet valve) of the catheter device is placed in the renal vein, and the distal one-way valve (outlet valve) is placed in the pulmonary artery.

[0091] Example 4

[0092] Another parallel circuit is connected to the working circuit of the system shown in the above embodiments 2 to 3, and combined with a one-way valve for controlling the direction of blood, blood circulation outside the body can be realized. On this basis, a modular interface is reserved on the parallel circuit, and an oxygenator module / dialysis module / heat exchange module can be connected to this interface respectively to realize the function of artificial lung and / or kidney replacement and / or regulating the temperature of circulating blood entering the body. Fig.16 The VA-ECMO mode with oxygenation / ultrafiltration module 13 connected in parallel circuit is demonstrated.

[0093] The above-mentioned implementation cases are only preferred implementation cases of the present invention and are not any formal and substantial limitations of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the present invention, and these improvements and supplements should also be regarded as the scope of protection of the present invention.

Claims

1. A catheter device for circulatory assistance, characterized in that: The catheter body comprises a distal one-way valve and a proximal one-way valve which are arranged at intervals. The distal one-way valve and the proximal one-way valve both have an outward valve port and a valve leaf which is driven to rotate by the pressure change inside the catheter body to open and close the valve port / flow channel thereof, and the valve leaf is rotatably connected to the flow channel of the one-way valve, and the valve leaves of the distal one-way valve and the proximal one-way valve rotate in opposite directions of opening and closing; The catheter device has a suction state and a liquid injection state. In the suction state, the valve leaf of the distal one-way valve and the valve leaf of the proximal one-way valve are driven inward by the negative pressure in the catheter body to close the flow channel, so that the valve port of the proximal one-way valve is connected with the inner cavity of the catheter body to form a suction channel; In the injection state, the positive pressure in the catheter body drives the valve leaves of the distal one-way valve and the valve leaves of the proximal one-way valve to close their valve ports outward and open their flow channels, so that the catheter body can pass through in the injection direction.

2. A catheter device for circulatory assistance according to claim 1, characterized in that: The proximal one-way valve is configured so that when the flow channel is closed, a gap is left between the valve leaf and the inner wall of the flow channel; the distal one-way valve is configured so that when the flow channel is closed, the valve leaf and the inner wall of the flow channel are in contact and sealed.

3. A catheter device for circulatory assistance according to claim 1, characterized in that: It also includes a distal outlet nozzle detachably connected to the end of the catheter body. The distal outlet nozzle is set as a cylindrical shell structure and is coaxial with the catheter body. The distal outlet nozzle is provided with a plurality of through holes communicating with the inner cavity of the catheter body.

4. A catheter device for circulatory assistance according to claim 3, characterized in that: The through hole of the distal outlet nozzle is divided into a plurality of side openings evenly distributed around the central axis of the distal outlet nozzle, and a central opening penetrating along the axial direction of the distal outlet nozzle.

5. A catheter device for circulatory assistance according to claim 4, characterized in that: The side opening is a strip-shaped hole structure and is parallel to the axial direction of the distal outlet nozzle.

6. A catheter device for circulatory assistance according to claim 3, characterized in that: The catheter body includes a first distal tube segment, a second distal tube segment and a proximal catheter segment. The two ends of the first distal tube segment are respectively connected to a distal outlet nozzle and a distal one-way valve, the two ends of the second distal tube segment are respectively connected to a distal one-way valve and a proximal one-way valve, and one end of the proximal catheter segment is connected to the proximal one-way valve.

7. A catheter device for circulatory assistance according to claim 6, characterized in that: The first distal tube segment, the second distal tube segment and the proximal catheter segment are a multi-layer composite catheter structure, which at least includes an outer layer, a middle layer and an inner layer; the inner layer and the outer layer are made of polymer materials, and the middle layer is a metal braided layer, a spring-wound layer, or a composite layer composed of a metal braided structure and a spring-wound structure; the surfaces of the inner layer and the outer layer are coated with an anti-coagulation coating.

8. A catheter device for circulatory assistance according to claim 6, characterized in that: Also included is a pump body communicated with the catheter body.

9. A catheter device for circulatory assistance according to claim 8, characterized in that: The pump body is a diaphragm pump, which comprises a blood chamber and a driving liquid chamber separated by a flexible diaphragm.

10. A catheter device for circulatory assistance according to claim 1, characterized in that: The distal one-way valve and / or the proximal one-way valve are provided with a pressure sensor.

11. A circulation assist system, characterized in that: It comprises a host computer control system and a catheter device as described in any one of claims 1 to 7, wherein the catheter device also comprises a pump body connected to the catheter body, the host computer control system comprises a host computer and a liquid drive system for driving the pump body to fill and discharge liquid, and the host computer is communicatively connected with the liquid drive system for monitoring and managing the operation and opening and closing of the liquid drive device.

12. A circulatory assist system according to claim 11, characterized in that: The pump body is a diaphragm pump, which includes a blood chamber and a driving liquid chamber separated by a flexible diaphragm. The host computer system also includes an electrocardiogram signal recognition module, which can recognize electrocardiogram signals. The host computer control system is configured to control the liquid drive system to fill or discharge the driving liquid chamber of the diaphragm pump through the recognized electrocardiogram signals to maintain synchronization with the natural rhythm of the patient's cardiac cycle.

13. A circulatory assist system according to claim 12, characterized in that: A parallel working circuit is also provided on the working pipeline connecting the diaphragm pump and the catheter body, and an oxygenator module and / or a dialysis module and / or a heat exchange module are connected to the parallel working circuit.

14. A circulatory assist system according to claim 11, characterized in that: The host computer system includes a pressure identification module, and a pressure sensor is provided on the distal one-way valve and / or the proximal one-way valve. The pressure identification module is electrically connected to the pressure sensor and the liquid drive system respectively. The pressure signal detected by the pressure sensor is fed back to the pressure identification module, and the host computer control system is configured to dynamically control the frequency and flow rate of filling or discharging liquid from the driving liquid chamber of the diaphragm pump by the liquid drive system through the pressure signal.

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