Trans-valve blood pump

Abstract

The invention relates to a trans-valve blood pump which comprises a pump body, an input pipe, an output pipe, a first one-way valve, a second one-way valve, a bag body, a catheter, a third one-way valve, a fourth one-way valve and a pressure generating mechanism. A first opening communicated with the first containing space and a second opening communicated with the first containing space are formed in the surface of the pump body, one end of the input pipe is connected with the first opening of the pump body, and one end of the output pipe is connected with the second opening of the pump body. According to the trans-valve blood pump, through the design that the third one-way valve and the fourth one-way valve are arranged on the catheter, blood of a patient replaces external fluid to drive the bag body to expand and contract, so that the problem that the external fluid enters blood circulation is effectively avoided, and the blood pump works more safely and reliably; the health risk caused by external fluid leakage is avoided, and the stability and adaptability of the equipment are improved.

Description

Technical Field

[0001] The present invention relates to a fluid pump, in particular to a transvalvular blood pump. Background Art

[0002] Heart failure (HF) is a common cardiovascular disease, which is mainly manifested by the systolic or diastolic dysfunction of the heart, resulting in the inability of blood to be effectively discharged from the heart, thus causing a series of clinical symptoms such as blood congestion and insufficient arterial perfusion. As the disease progresses, patients may experience serious circulation problems such as pulmonary congestion, vena cava congestion, and hypotension, which seriously affect the patient's quality of life and survival rate. In order to meet this challenge, modern medicine has adopted various blood circulation assistance devices, including left ventricular assist devices, right ventricular assist devices, total artificial hearts, and balloon transvalvular blood pumps. In particular, balloon transvalvular blood pumps, which are placed in the patient's heart or aorta, use the expansion and contraction of the balloon to assist the heart to pump blood, effectively increase ventricular output, improve aortic pressure and coronary artery perfusion, and have become an important means of clinical treatment of heart failure.

[0003] The existing balloon-type transvalvular blood pump mainly includes key components such as a pump body, a balloon, an input tube, an output tube, and a one-way valve. In this device, the pump body is usually provided with two accommodating spaces, which are connected to the input tube and the output tube through an opening. Blood enters from the input tube, and is discharged from the output tube after the balloon expands and contracts. A one-way valve is installed to control the unidirectional flow of the fluid, thereby achieving effective pumping of blood. The expansion and contraction of the balloon is driven by an external working fluid (gas or liquid). This design is commonly found in various types of transvalvular blood pumps. In the prior art, the auxiliary effect of the heart's pumping function can be achieved by inflating and deflating the balloon and controlling the one-way valve in the pipeline.

[0004] Although the existing balloon-type transvalvular blood pump has achieved certain results in the treatment of heart failure, its design also has some significant deficiencies. In particular, when the expansion and contraction of the balloon and the one-way valve are driven by external fluid, once the operating frequency is too high, or the balloon and the one-way valve are subjected to uneven squeezing or material aging, the external fluid may leak and enter the patient's blood circulation. This leakage will not only affect the normal operation of the blood pump, but may also cause gas or other impurities to appear in the patient's body, seriously endangering the patient's health. Therefore, how to further improve the transvalvular blood pump and enhance the safety and stability of the equipment has become an urgent problem to be solved. Summary of the invention

[0005] The object of the present invention is to provide an improved transvalvular blood pump, which overcomes the safety hazard caused by external fluid leakage during high-frequency operation of the balloon and the one-way valve in the prior art by optimizing the pump body structure, the one-way valve configuration and the fluid control mechanism, thereby improving the working stability and safety of the blood pump, ensuring its reliable operation over a long period of time, preventing external fluid from entering the patient's blood circulation, and improving the treatment effect and quality of life of patients with heart failure.

[0006] The technical solution adopted by the present invention to solve the above problem is: a transvalvular blood pump, comprising:

[0007] The pump body comprises a first accommodating space, and a first opening communicating with the first accommodating space and a second opening communicating with the first accommodating space are formed on the surface of the pump body.

[0008] An input pipe, one end of which is connected to the first opening of the pump body.

[0009] An output pipe, one end of which is connected to the second opening of the pump body.

[0010] The first one-way valve is arranged at the other end of the input pipe, the first one-way valve is driven by the internal pressure of the input pipe, and the first one-way valve is configured to only allow the external fluid to flow into the input pipe when the input pipe is connected to the external environment.

[0011] The second one-way valve is arranged at the other end of the output pipe, the second one-way valve is driven by the internal pressure of the output pipe, and the second one-way valve is configured to only allow the fluid in the output pipe to flow to the outside when the output pipe is connected to the external environment.

[0012] The sac is arranged in the first accommodating space so that the outer surface of the sac and the inner wall of the first accommodating space form a pump chamber. The sac includes a second accommodating space, and the sac is configured to shrink or expand in the first accommodating space to change the volume of the pump chamber.

[0013] A conduit, one end of which is connected to the first one-way valve and extends to the outside of the input pipe, the other end of which is connected to the second one-way valve and extends to the outside of the output pipe, a portion of the conduit located between the first directional valve and the second one-way valve is connected to the sac, and a flow channel is configured at the portion of the conduit connected to the sac so that the interior of the conduit is in communication with the second accommodating space in the sac.

[0014] A third one-way valve is arranged on the side of the conduit, and the third one-way valve is located outside the pump body, the input pipe and the output pipe. The third one-way valve is driven by the internal pressure of the conduit. The third one-way valve is configured to only allow the liquid in the conduit to flow to the outside when in a connected state.

[0015] A fourth one-way valve is arranged on the side of the catheter, and the fourth one-way valve is located outside the pump body, the input pipe and the output pipe. The fourth one-way valve is driven by the internal pressure of the catheter. The fourth one-way valve is configured to only allow liquid in the external environment to flow into the catheter when in a connected state.

[0016] The pressure generating mechanism is connected to one end of the conduit close to the second one-way valve to adjust the internal pressure of the conduit.

[0017] Preferably, the third one-way valve and the fourth one-way valve are respectively arranged on both sides of the input pipe and the output pipe, and the distance between the third one-way valve and the input pipe is smaller than the distance between the fourth one-way valve and the input pipe.

[0018] Preferably, the third one-way valve and the fourth one-way valve are both arranged on the side of the conduit away from the output pipe, and the distance between the third one-way valve and the fourth one-way valve and the input pipe is greater than the distance between the third one-way valve and the fourth one-way valve and the output pipe.

[0019] Preferably, the distance between the third one-way valve and the output pipe is equal to the distance between the fourth one-way valve and the output pipe.

[0020] Preferably, the distance between the third one-way valve and the output pipe is smaller than the distance between the fourth one-way valve and the output pipe.

[0021] Preferably, the distance between the third one-way valve and the output pipe is greater than the distance between the fourth one-way valve and the output pipe.

[0022] Preferably, the pressure generating mechanism comprises:

[0023] A cylinder body is connected to one end of the conduit extending to the outside of the second one-way valve, and the cylinder body includes a third accommodating space extending along the first direction.

[0024] A piston is disposed in the third accommodating space of the cylinder body and is controlled to move along the first direction, and an outer peripheral side of the piston is in contact with an inner wall of the third accommodating space to separate the third accommodating space into a first area and a second area independent of each other, and the first area is connected to the interior of the conduit.

[0025] Preferably, the pressure generating mechanism comprises:

[0026] A cylinder body is connected to one end of the conduit extending to the outside of the second one-way valve, and the cylinder body includes a third accommodating space.

[0027] A diaphragm is arranged in the third accommodating space to divide the third accommodating space into relatively independent third and fourth areas, the fourth area is connected to the conduit, and the diaphragm is configured to contract or expand when subjected to pressure so that the volume of the fourth area changes.

[0028] Preferably, the transvalvular blood pump further comprises:

[0029] A first pressure sensor is disposed at one end of the conduit extending to the outside of the first one-way valve, and a wire connected to the first pressure sensor is disposed in the conduit.

[0030] A controller is connected to the wire.

[0031] Preferably, a wire tube is provided on the side of the conduit extending to the outside of the first one-way valve, and a connecting hole is opened on the inner wall of the conduit to connect the wire tube with the inside of the conduit. The end of the wire facing away from the first pressure sensor passes through the connecting hole and extends into the wire tube to be connected to the controller, and a sealing filler is provided at the connection between the wire and the connecting hole.

[0032] Beneficial effects of the embodiments of the present invention:

[0033] The transvalvular blood pump is designed with a third one-way valve and a fourth one-way valve on the catheter, which utilizes the patient's own blood instead of external fluid to drive the expansion and contraction of the balloon, thereby effectively avoiding the problem of external fluid entering the blood circulation, thereby achieving safer and more reliable operation of the blood pump, avoiding health risks caused by external fluid leakage, and improving the stability and adaptability of the equipment.

[0034] This transvalvular blood pump discharges the blood in the balloon through the third one-way valve and introduces blood into the patient's aorta through the fourth one-way valve, thereby achieving the renewal and replacement of the blood in the catheter that drives the contraction and expansion of the balloon. It can avoid problems such as blood deterioration, coagulation or contamination caused by long-term retention of blood in the pump body, further improves the safety and therapeutic effect of the blood pump, and ensures that the patient receives continuous and safe blood circulation assistance. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 FIG. 1 is a schematic structural diagram of a transvalvular blood pump according to an embodiment of the present invention. Figure 1 .

[0036] Figure 2 4 is a cross-sectional view of a transvalvular blood pump according to an embodiment of the present invention.

[0037] Figure 3 FIG. 1 is a schematic structural diagram of a transvalvular blood pump according to an embodiment of the present invention. Figure 2 .

[0038] Figure 4 Schematic flowchart of a method for controlling a transvalvular blood pump according to an embodiment of the present invention Figure 1 .

[0039] Figure 5 Schematic flowchart of a method for controlling a transvalvular blood pump according to an embodiment of the present invention Figure 2 .

[0040] Among them: 100, transvalvular blood pump; 110, pump body; 111, first accommodating space; 120, input tube; 130, output tube; 140, first one-way valve; 150, second one-way valve; 160, capsule; 161, second accommodating space; 170, catheter; 171, flow channel; 180, third one-way valve; 190, fourth one-way valve; 1100, pressure generating mechanism; 1101, cylinder body; 1102, piston; 1110, first pressure sensor; 1120, wire; 1130, wire tube. DETAILED DESCRIPTION

[0041] The specific implementation methods of the present application are further described in detail below in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present application but are not intended to limit the scope of the present application.

[0042] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the scope of protection of the present application. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description created by the present application, unless otherwise specified, "multiple" means two or more.

[0043] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood by specific circumstances.

[0044] like Figure 1 to Figure 2As shown, a preferred embodiment of the present application provides a transvalvular blood pump 100, including a pump body 110, an input tube 120, an output tube 130, a first one-way valve 140, a second one-way valve 150, a capsule 160, a catheter 170, a third one-way valve 180, a fourth one-way valve 190 and a pressure generating mechanism 1100. The pump body 110 includes a first accommodating space 111, and a first opening communicating with the first accommodating space 111 and a second opening communicating with the first accommodating space 111 are provided on the surface of the pump body 110. One end of the input tube 120 is connected to the first opening of the pump body 110, and one end of the output tube 130 is connected to the second opening of the pump body 110. The first one-way valve 140 is arranged at the other end of the input pipe 120, the first one-way valve 140 is driven by the internal pressure of the input pipe 120, and the first one-way valve 140 is configured to only allow the external fluid to flow into the input pipe 120 when the input pipe 120 is connected to the external environment. The second one-way valve 150 is arranged at the other end of the output pipe 130, the second one-way valve 150 is driven by the internal pressure of the output pipe 130, and the second one-way valve 150 is configured to only allow the fluid in the output pipe 130 to flow to the outside when the output pipe 130 is connected to the external environment. The capsule 160 is arranged in the first accommodating space 111, so that the outer surface of the capsule 160 and the inner wall of the first accommodating space 111 are surrounded to form a pump chamber, the capsule 160 includes a second accommodating space 161, and the capsule 160 is configured to shrink or expand in the first accommodating space 111 to adjust the size of the second accommodating space 161, thereby changing the volume of the pump chamber. One end of the conduit 170 is connected to the first one-way valve 140 and extends to the outside of the input pipe 120. The other end of the conduit 170 is connected to the second one-way valve 150 and extends to the outside of the output pipe 130. The portion of the conduit 170 between the first one-way valve 140 and the second one-way valve 150 is connected to the capsule 160. The portion of the conduit 170 connected to the capsule 160 is configured with a flow channel 171 so that the interior of the conduit 170 is communicated with the second accommodation space 161 in the capsule 160. A third one-way valve 180 is disposed on the side of the conduit 170 and is located outside the pump body 110, the input pipe 120 and the output pipe 130. The third one-way valve 180 is driven by the internal pressure of the conduit 170. The third one-way valve 180 is configured to only allow the liquid in the conduit 170 to flow to the outside when in a connected state.The fourth one-way valve 190 is arranged on the side of the catheter 170, and the fourth one-way valve 190 is located outside the pump body 110, the input tube 120 and the output tube 130. The fourth one-way valve 190 is driven by the internal pressure of the catheter 170. The fourth one-way valve 190 is configured to only allow the liquid in the external environment to flow into the catheter 170 when in the connected state. The pressure generating mechanism 1100 is connected to one end of the catheter 170 close to the second one-way valve 150 to adjust the internal pressure of the catheter 170. The transvalvular blood pump 100 in this embodiment can be used for patients with heart failure. The pump body 110 needs to be placed in the ventricle through interventional surgery, etc., and the output tube 130 is placed in the aorta across the heart valve to extract blood in the ventricle and pump it into the aorta.

[0045] The pump body 110 can be embodied as a cylinder in a specific manner. Taking the cylinder as an example, Figure 2 As shown, the material of the pump body 110 can be selected to be made of medical-grade biocompatible plastic, metal or composite material to ensure its strength and stability, and at the same time have good biocompatibility. The function of the pump body 110 is to provide a storage space for the capsule 160, and to control the blood flow by connecting with the input tube 120 and the output tube 130. Through the precise design of the pump body 110, the capsule 160 can be effectively accommodated and protected, while ensuring the effective pumping and contraction of blood in the pump chamber. When the volume of the capsule 160 changes, the pressure in the first accommodation space 111 will also change accordingly. During the contraction of the capsule 160, negative pressure will be generated in the first accommodation space 111, thereby extracting blood in the ventricle, so that the blood flows into the first accommodation space 111 through the first one-way valve 140 and the input tube 120, and when the capsule 160 expands, the pressure in the first accommodation space 111 will rise, so that the blood in the first accommodation space 111 will be discharged to the aorta along the output tube 130 and the second one-way valve 150.

[0046] One end of the input tube 120 is connected to the first opening of the pump body 110, and the other end is provided with a first one-way valve 140. The inner wall of the tube is smooth and has a certain elasticity. One end of the output tube 130 is connected to the second opening of the pump body 110, and the other end is provided with a second one-way valve 150. The input tube 120 is a slender tube, which is convenient for insertion into the patient's body through interventional surgery, and has a certain flexibility to adapt to the position of the ventricle and the catheter 170. The shape of the output tube 130 is similar to that of the input tube 120, but the size is slightly different to adapt to the outflow of blood in the pump body 110. Both the input tube 120 and the output tube 130 can be made of medical grade polymer or silicone material to ensure the biocompatibility of the tube and the anti-blood coagulation performance. The input tube 120 is responsible for guiding the blood in the ventricle to flow into the pump body 110, driving the contraction and expansion of the capsule 160, and, due to the optimization of its material and shape, the input tube 120 can maintain the smooth flow of blood and ensure that the blood effectively enters the pump body 110. The function of the output tube 130 is to transport the blood after expansion and contraction of the balloon 160 to the aorta to ensure blood circulation. In addition, the optimized design ensures smooth blood flow while avoiding backflow and blood retention.

[0047] The first one-way valve 140 is installed at the other end of the input tube 120. It has a simple structure and is usually composed of a valve flap and a valve seat, and matches the size and shape of the input tube 120. The first one-way valve 140 is often made of biocompatible materials, such as silicone, plastic or stainless steel, to ensure the flexibility and durability of the valve flap. In addition, the first one-way valve 140 is driven by the internal pressure of the input tube 120 (i.e., driven by the pressure in the first accommodating space 111 caused by the volume change of the capsule 160), ensuring that only external fluid is allowed to flow into the input tube 120. The first one-way valve 140 can effectively prevent blood from flowing back and ensure the one-way flow of blood, thereby improving the pumping efficiency.

[0048] The second one-way valve 150 is installed at the other end of the output tube 130. The structure is similar to the first one-way valve 140 and matches the size of the output tube 130 to ensure smooth blood flow. The second one-way valve 150 is made of biocompatible materials and has corrosion resistance and anti-coagulation properties. The second one-way valve 150 is driven by the internal pressure of the output tube 130 (i.e., driven by the pressure in the first accommodating space 111 caused by the volume change of the capsule 160) to ensure that blood only flows out of the output tube 130 to avoid backflow. Ensure that blood flows smoothly to the aorta and improve the working efficiency of the blood pump.

[0049] It can be understood that the first one-way valve 140 , the second one-way valve 150 , the third one-way valve 180 and the fourth one-way valve 190 are all prior art.

[0050] Specifically, the one-way valve structure includes a valve flap and a valve seat structure, wherein the core part of the one-way valve is the valve flap, which is usually made of lightweight, flexible and corrosion-resistant materials. The valve flap is usually disc-shaped or other shapes suitable for fluid flow, which can quickly respond to changes in internal pressure and ensure the flexibility of the valve. Biocompatible materials such as silicone, polyurethane, medical silicone rubber or certain biocompatible metal alloys (such as titanium alloy, cobalt-chromium alloy) are used to ensure that no toxic reaction occurs when in contact with the human body. When the internal pressure is high, the valve flap will be pressed against the valve seat to close the valve port; when the fluid direction and pressure difference cause the valve flap to be pushed away from the valve seat, the valve opens and the fluid can flow. The valve seat is the part where the valve flap contacts the valve and forms a seal. The valve seat is usually an annular component fixed in the valve body to ensure that the valve flap is completely sealed when the valve flap is closed. The valve seat is usually made of a material with a higher hardness, such as stainless steel, titanium alloy or polytetrafluoroethylene (PTFE), to ensure its wear resistance and corrosion resistance. The one-way valve is driven by pressure difference. By properly designing the elasticity of the valve disc and the working pressure range, the valve can be opened quickly in a specific direction and closed in time when the reverse flow occurs to prevent reverse flow.

[0051] Furthermore, in general, the valve flap design of the one-way valve does need to add an elastic member (such as a spring) to control the closure of the valve flap. This is because the elastic member provides an adjustable reaction force, which enables the valve flap to close quickly and stably when the fluid pressure changes, avoiding unnecessary backflow. Specifically, the elastic member is crucial to the function and reliability of the one-way valve, especially in high-frequency opening and closing and medical device applications. Specifically, the elastic member (usually a spring) can generate a certain preload force between the valve flap and the valve seat, thereby ensuring that the valve flap will be tightly closed to prevent backflow when there is no external fluid pressure. This is particularly important for the transvalvular blood pump 100, because the blood should not flow back into the pump body 110 or back into other pipelines to avoid blood contamination or other complications. Elastic members are usually made of metal materials with good elasticity (such as stainless steel or titanium alloy), which have strong corrosion resistance, high temperature resistance and good biocompatibility. The design of the elastic member should ensure that the valve flap opens and closes under appropriate pressure differences. In order to accurately control the opening pressure and closing pressure, the stiffness, preload and length of the spring need to be accurately calculated and optimized. The elastic member can adjust the opening / closing speed of the valve flap so that the valve flap can respond quickly when the fluid pressure changes. Especially in the transvalvular blood pump 100, the valve flap needs to be synchronized with the blood flow to ensure the unidirectional flow of the fluid during the pumping process, and the elastic member can make the valve flap flexibly adjusted to avoid valve flap hysteresis or premature closure. The elastic member not only helps to control the opening and closing of the valve flap, but also ensures the close contact between the valve flap and the valve seat, providing a better sealing effect. This is very important to prevent blood reflux, especially in blood circulation, avoiding reflux can reduce the risk of thrombosis and blood contamination. When designing the spring, the required closing pressure and the flow characteristics of the fluid must be taken into account. The rigidity of the spring needs to match the working conditions of the blood pump (such as flow, blood pressure, etc.) to ensure that the valve flap can be properly opened under fluid pressure while avoiding premature closure or failure to close completely. In addition, the design of the elastic part and the valve flap also needs to work in coordination to ensure that the spring does not affect the smooth flow of fluid during blood flow, while maintaining the rapid response capability of the valve flap.

[0052] The sac 160 is provided with a second accommodation space 161, and can freely contract or expand in the first accommodation space 111 of the pump body 110. The sac 160 is usually flexible spherical or elliptical, and can expand and contract as the pressure in the pump body 110 changes. It can be made of a flexible material with high biocompatibility, such as medical silicone or rubber, which has good elasticity and durability. The sac 160 adjusts the volume of the pump chamber by expansion and contraction, thereby driving blood flow and assisting the heart in pumping blood. The design of the sac 160 ensures the effective supplementation of the heart function, and can withstand certain pressure changes, thereby extending the service life of the blood pump.

[0053] One end of the catheter 170 is connected to the first one-way valve 140, the other end is connected to the second one-way valve 150, and the middle part thereof is connected to the capsule 160 to form a flow channel 171. The catheter 170 is an elongated tubular having a flow channel 171 therein, and is designed to be connected to the pump body 110 and the one-way valve. Medical grade silicone or other flexible materials are used to ensure the biocompatibility, flexibility and durability of the catheter 170. The catheter 170 is used to guide and transport blood to the capsule 160, and to achieve blood renewal and replacement by connecting the third one-way valve 180 and the fourth one-way valve 190. Moreover, the catheter 170 can effectively control the flow of blood and ensure that the blood will not leak or be retained.

[0054] The third one-way valve 180 is located on the side of the catheter 170, and is usually composed of a valve flap and a valve seat, and is driven by the internal pressure of the catheter 170. It is small in size, and the connection part with the catheter 170 is compactly designed. It can be made of biocompatible materials such as silicone, plastic or stainless steel, and has durability and stability. The third one-way valve 180 ensures that only the liquid in the catheter 170 is allowed to flow out, and is used to renew the blood in the catheter 170, which can effectively prevent the blood in the catheter 170 from staying for a long time, and ensure the freshness and pumping efficiency of the blood.

[0055] The fourth one-way valve 190 is similar to the third one-way valve 180, and is disposed on the side of the catheter 170 and driven by the internal pressure of the catheter 170. It is connected to the catheter 170, is compact and can be made of medical-grade materials, and is resistant to blood corrosion. The fourth one-way valve 190 ensures that liquid in the external environment can flow into the catheter 170 to replace and renew the blood in the catheter 170. It ensures that the blood can be replaced regularly to keep the blood in the catheter 170 fresh and safe.

[0056] The pressure generating mechanism 1100 is connected to the catheter 170 and is located at one end of the catheter 170 close to the second one-way valve 150. It is usually a pumping device or a gas injection device and has an appropriate shape according to design requirements. The pressure generating mechanism 1100 can adjust the internal pressure of the catheter 170 to drive the blood flow and the expansion and contraction of the balloon 160. In addition, the pressure generating mechanism 1100 can ensure that the blood pump can maintain a stable working pressure under different working conditions, thereby ensuring the efficient operation of the blood pump.

[0057] The transvalvular blood pump 100 in this embodiment is designed with a third one-way valve 180 and a fourth one-way valve 190 on the catheter 170, and utilizes the patient's own blood to replace the external fluid to drive the expansion and contraction of the capsule 160, thereby effectively avoiding the problem of external fluid entering the blood circulation, thereby achieving safer and more reliable operation of the blood pump, avoiding health risks caused by external fluid leakage, and improving the stability and adaptability of the equipment.

[0058] Furthermore, the transvalvular blood pump 100 discharges the blood in the balloon 160 through the third one-way valve 180 and introduces the blood into the patient's aorta through the fourth one-way valve 190, thereby realizing the renewal and replacement of the blood in the catheter 170 that drives the contraction and expansion of the balloon 160. This can avoid problems such as blood deterioration, coagulation or contamination caused by long-term retention of blood in the pump body 110, further improving the safety and therapeutic effect of the blood pump, and ensuring that the patient receives continuous and safe blood circulation assistance.

[0059] In some embodiments, Figure 2 As shown, the pressure generating mechanism 1100 includes a cylinder 1101 and a piston 1102. The cylinder 1101 is connected to one end of the conduit 170 extending to the outside of the second one-way valve 150, and the cylinder 1101 includes a third accommodation space, which extends along the first direction. The piston 1102 is disposed in the third accommodation space of the cylinder 1101, and the piston 1102 is controlled to move along the first direction, and the outer side surface of the piston 1102 is in contact with the inner wall of the third accommodation space to separate the third accommodation space into a first area and a second area that are independent of each other, and the first area is connected to the inside of the conduit 170.

[0060] Specifically, the cylinder 1101 is a container, usually with a hollow structure, providing a third accommodation space for accommodating the piston 1102 and allowing it to move along a specified direction (first direction). The third accommodation space is generally cylindrical, and the inner wall of the cylinder 1101 fits the outer peripheral side of the piston 1102 to form a separated area to ensure the sealing of the piston 1102 during movement. One end of the cylinder 1101 is connected to the conduit 170, and the other end is connected to a mechanical or electrical system related to pressure regulation.

[0061] The piston 1102 is a movable component that is disposed in the cylinder 1101 and is controlled by an external drive system. The piston 1102 is usually circular or cylindrical, and its outer circumference fits the inner wall of the cylinder 1101. The length of the piston 1102 is usually adapted to the length of the cylinder 1101 to ensure that it can slide freely in the cylinder 1101 without leakage. The outer side of the piston 1102 may be equipped with a sealing ring or other sealing materials to improve the sealing effect. The outer side of the piston 1102 fits tightly against the inner wall of the cylinder 1101 to ensure that there is no leakage when the piston 1102 moves in the first direction. The function of the piston 1102 is to separate the internal space of the cylinder 1101 into two independent areas and adjust the pressure in each area as needed. The piston 1102 adjusts the pressure difference between the first area and the second area by moving in the cylinder 1101, thereby achieving precise control of the internal pressure of the catheter 170, which is a very critical function in the transvalvular blood pump 100, which helps to adjust the working state of the blood pump and ensure the stability and flow of blood flow. In addition, the presence of the piston 1102 separates the third accommodating space of the cylinder 1101 into two independent areas, wherein the first area is connected to the catheter 170 for controlling the flow of liquid or blood, and the second area is used to receive the adjustment signal of the external pressure control system. Such a design helps to accurately adjust the fluid pressure and can respond in real time as needed. The position and movement direction of the piston 1102 can be controlled by an external pressure source, electrical control or mechanical drive system. By adjusting the displacement of the piston 1102, dynamic regulation of blood flow can be achieved, thereby optimizing the working effect of the transvalvular blood pump 100.

[0062] In this embodiment, the pressure generating mechanism 1100 can accurately control the pressure of the catheter 170 in the transvalvular blood pump 100 by combining the cylinder 1101 and the piston 1102, thereby optimizing the pumping process. This design not only improves the working efficiency, stability and safety of the blood pump, but also can adjust the pressure change in real time under different operating conditions to ensure the reliability of blood flow.

[0063] In some other embodiments, the pressure generating mechanism 1100 includes a cylinder body 1101 and a diaphragm (not shown in the figure), the cylinder body 1101 is connected to one end of the conduit 170 extending to the outside of the second one-way valve 150, the cylinder body 1101 includes a third accommodating space, the diaphragm is arranged in the third accommodating space to divide the third accommodating space into relatively independent third and fourth areas, the fourth area is connected to the conduit 170, and the diaphragm is configured to contract or expand when subjected to pressure so that the volume of the fourth area changes.

[0064] Specifically, the cylinder 1101 is the main component of the pressure generating mechanism 1100, and its function is to accommodate the diaphragm and provide space for the movement of the diaphragm. A third accommodation space is provided in the cylinder 1101, and the diaphragm is located in the accommodation space. One end of the cylinder 1101 is connected to the catheter 170, and the other end may be connected to an external pressure source or a control system. The shape of the cylinder 1101 is usually cylindrical or other geometric shapes suitable for accommodating the diaphragm, which can stably support the movement of the diaphragm when under pressure. The diaphragm is a thin elastic component, usually made of a soft but high-strength material. The circumference of the diaphragm is attached and connected to the inner wall of the cylinder 1101, and it will shrink or expand when subjected to external pressure. The main function of the diaphragm is to change the volume of the fourth area through its deformation, thereby adjusting the fluid pressure in the catheter 170. The diaphragm divides the third accommodation space of the cylinder 1101 into two independent spaces, the third area and the fourth area. The fourth area is connected to the catheter 170, allowing the pressure of blood flow to be controlled through the space. The third area is connected to an external pressure source or control system to adjust the contraction or expansion of the diaphragm. The main function of the diaphragm is to adjust the volume of the fourth area. Under the action of pressure, the diaphragm will contract or expand, thereby controlling the pressure of the liquid or blood flow in the catheter 170. The diaphragm can accurately control the pressure in the catheter 170 according to the adjustment of the external pressure source or control system, thereby adjusting the working state of the transvalvular blood pump 100. The fourth area is connected to the catheter 170. By changing the volume of the fourth area, the diaphragm directly affects the pressure change of the liquid in the catheter 170. The third area reversely affects the movement of the diaphragm by controlling the input of the external pressure regulation system. When the diaphragm is subjected to pressure, it will change shape and become more concave or expanded. This process directly affects the volume of the fourth area in the cylinder 1101, thereby adjusting the rate and pressure of blood flow.

[0065] This embodiment selects the design of the pressure generating mechanism 1100 composed of the cylinder 1101 and the diaphragm, so that the diaphragm can accurately adjust the liquid pressure in the blood pump catheter 170 during the contraction and expansion process. This design has the advantages of high efficiency, precision and stability, which not only ensures the stable operation of the transvalvular blood pump 100, but also improves the safety and effectiveness of the treatment process.

[0066] In some embodiments, as shown in the title, the third one-way valve 180 and the fourth one-way valve 190 are respectively arranged on both sides of the input pipe 120 and the output pipe 130, and the distance between the third one-way valve 180 and the input pipe 120 is smaller than the distance between the fourth one-way valve 190 and the input pipe 120.

[0067] Specifically, the third one-way valve 180 is located at the input end of the catheter 170, and its function is to ensure that blood can only enter the catheter 170 from the input tube 120, and cannot flow back to the input tube 120. This ensures the consistency of the blood flow direction and prevents the blood in the input tube 120 from flowing back to other parts or the external environment. The fourth one-way valve 190 is located at the output end of the catheter 170, ensuring that the blood flows to the output tube 130 and preventing the blood from flowing back to the catheter 170 or the ventricle. In this way, it can prevent the blood from staying in the catheter 170 or flowing back, and ensure that the blood flows smoothly to the aorta.

[0068] Since the third one-way valve 180 and the fourth one-way valve 190 of the transvalvular blood pump 100 are respectively arranged at the input end and the output end of the catheter 170, such a layout can effectively separate the blood flow path and prevent the blood from flowing back or becoming chaotic inside the catheter 170. Such separation ensures that the blood flow in the pump body 110 is smoother and more accurate. The reasonable arrangement of the third one-way valve 180 and the fourth one-way valve 190 can also avoid the problem of blood accumulation or retention inside the catheter 170, thereby improving the blood flow efficiency and pumping effect. In addition, this design can also optimize the blood flow path and pressure regulation, making the pump body 110 more stable and efficient during operation, thereby reducing equipment failures and maintenance requirements.

[0069] It should be noted that when the first accommodating space 111 is in a negative pressure state, the third one-way valve 180 is in a closed state and the fourth one-way valve 190 is in an open state, and when the first accommodating space 111 is in a positive pressure state, the third one-way valve 180 is in an open state and the fourth one-way valve 190 is in a closed state.

[0070] This embodiment adopts the technical means that when the first accommodating space 111 is in a negative pressure state, the third one-way valve 180 is in a closed state, and the fourth one-way valve 190 is in an open state; and when the first accommodating space 111 is in a positive pressure state, the third one-way valve 180 is in an open state, and the fourth one-way valve 190 is in a closed state, so that the flow direction and flow rate of blood inside the blood pump can be accurately controlled. Specifically, when the first accommodating space 111 is in a negative pressure state, the third one-way valve 180 is closed, and the fourth one-way valve 190 is opened, ensuring that blood flows into the input tube 120 and enters the pump body 110; and when the first accommodating space 111 is in a positive pressure state, the third one-way valve 180 is opened, and the fourth one-way valve 190 is closed, and the blood is effectively pushed to the output tube 130 to flow out. This method of adjusting the valve by negative and positive pressure states realizes the renewal of the blood in the catheter 170 that drives the contraction and expansion of the balloon 160, and can avoid problems such as blood deterioration, coagulation or contamination caused by long-term retention of blood in the pump body 110. This not only improves the safety and reliability of the blood pump system, but also ensures the quality of blood and the stable operation of the blood pump, thereby enhancing the adaptability and effect of the device in long-term use.

[0071] In some embodiments, Figure 3 As shown, the third one-way valve 180 and the fourth one-way valve 190 are both arranged on the side of the conduit 170 away from the output pipe 130, and the distance between the third one-way valve 180 and the fourth one-way valve 190 and the input pipe 120 is greater than the distance between the third one-way valve 180 and the fourth one-way valve 190 and the output pipe 130.

[0072] In this embodiment, the third one-way valve 180 and the fourth one-way valve 190 are both arranged on the side of the catheter 170 away from the output tube 130. Through precise valve control, the separation of waste blood and new blood is more thorough, avoiding blood mixing or backflow into the pump body 110, and further improving the accuracy and safety of blood replacement. This structural design controls the flow direction and pressure change of blood in the catheter 170 through the position of the valve, reducing the problem of blood retention or unstable flow caused by improper valve operation or unreasonable position. In addition, more effective blood renewal is achieved during the working process, avoiding aging or contamination of blood that has been retained in the pump body 110 for a long time, thereby maintaining the freshness of the blood quality in the pump body 110, reducing the health risks caused by blood retention, and improving the effect of blood circulation.

[0073] In some embodiments, the distance between the third one-way valve 180 and the output pipe 130 is equal to the distance between the fourth one-way valve 190 and the output pipe 130 .

[0074] In this embodiment, due to the technical means of setting the distance between the third one-way valve 180 and the output tube 130 to be equal to the distance between the fourth one-way valve 190 and the output tube 130, the problems of uneven blood flow, backflow and low efficiency caused by asymmetric valve positions in the prior art are effectively solved. Specifically, this configuration ensures that blood can flow smoothly in the catheter 170 during the operation of the blood pump, avoiding the problems of blood retention, coagulation or contamination caused by uneven flow. By making the distance between the two valves equal, a more uniform pressure distribution can be achieved in the catheter 170, ensuring the stable flow of blood, improving the efficiency of blood replacement, and reducing the potential risks caused by uneven pressure. This technical means greatly improves the stability, adaptability and safety of the blood pump system.

[0075] In some embodiments, the distance between the third one-way valve 180 and the output pipe 130 is smaller than the distance between the fourth one-way valve 190 and the output pipe 130 .

[0076] In this embodiment, the technical means of making the distance between the third one-way valve 180 and the output tube 130 smaller than the distance between the fourth one-way valve 190 and the output tube 130 is adopted, which effectively solves the problems of unstable blood flow, low blood reflux and replacement efficiency caused by unreasonable valve position configuration in the prior art. Specifically, this design allows the blood to be discharged from the catheter 170 preferentially through the third one-way valve 180, which is closer, when flowing in the pump body 110, so as to ensure that the blood in the catheter 170 flows more smoothly and is discharged in a timely manner. The fourth one-way valve 190, which is farther away, plays a role in further guiding the external blood to flow into the catheter 170, forming a good pressure and flow control, and effectively avoiding the problems of blood retention, reflux or uneven flow.

[0077] This technical configuration optimizes the blood replacement process, improves the efficiency of blood renewal, and can more accurately control the blood flow path, avoid blood stagnation in the catheter 170, and prevent blood coagulation or deterioration. In addition, through this configuration, the blood flow in the pump body 110 can be more stably regulated, improving the overall working efficiency and safety of the blood pump, and enhancing the adaptability and reliability of the blood pump system.

[0078] In some embodiments, the distance between the third one-way valve 180 and the output pipe 130 is greater than the distance between the fourth one-way valve 190 and the output pipe 130 .

[0079] In this embodiment, the technical means of making the distance between the third one-way valve 180 and the output tube 130 greater than the distance between the fourth one-way valve 190 and the output tube 130 is adopted, which effectively solves the problem of poor blood flow and serious reflux caused by unreasonable valve position in the prior art. Specifically, the design of the third one-way valve 180 being far away from the output tube 130 enables the valve to prevent external blood from reflux during blood flow and ensure the normal flow direction of blood in the pump body 110. At the same time, the design of the fourth one-way valve 190 being close to the output tube 130 helps to timely and accurately control the blood from the catheter 170 into the pump body 110, and promotes the discharge of waste blood, reducing blood retention and unnecessary reflux.

[0080] In summary, by configuring the different distances between the third one-way valve 180 and the fourth one-way valve 190 on the output tube 130 , a flexible valve arrangement scheme is provided, thereby effectively optimizing blood flow control, replacement of waste blood and stability of operation of the pump body 110 .

[0081] The technical means of adjusting the relative distance between the third one-way valve 180 and the fourth one-way valve 190 is adopted to effectively solve the problems of poor blood flow, inaccurate valve control and waste blood retention caused by unreasonable valve arrangement in the prior art.

[0082] When the valve distances are equal (the distance between the third one-way valve 180 and the output tube 130 is equal to the distance between the fourth one-way valve 190 and the output tube 130), the balance of valve control is achieved, making the blood flow path more stable, avoiding backflow, blockage, etc. caused by inconsistent valve positions. Blood can enter the pump body 110 more smoothly from the catheter 170 and be effectively discharged, thereby avoiding blood retention and deterioration.

[0083] The distance between the third one-way valve 180 and the output tube 130 is smaller than the distance between the fourth one-way valve 190 and the output tube 130. This configuration helps to achieve precise control of blood flow, especially in preventing blood reflux and timely discharge of waste blood, thereby reducing the possibility of reflux, improving the working efficiency of the pump body 110, and avoiding unnecessary blood stagnation.

[0084] The distance between the third one-way valve 180 and the output tube 130 is greater than the distance between the fourth one-way valve 190 and the output tube 130. This configuration can effectively control the flow direction of blood in the pump body 110, ensure that the blood flows into the pump body 110 preferentially, prevent the backflow of external blood, and can discharge the waste blood in a timely and effective manner, avoiding blood coagulation or deterioration due to long-term retention.

[0085] Therefore, through these three different configurations, the path and direction of blood flow can be flexibly adjusted according to actual needs, ensuring smoother and more efficient blood flow, avoiding problems such as retention and reflux, improving the reliability and stability of the blood pump system, and enhancing the efficiency of blood replacement, thereby improving the safety and performance of the entire blood pump system.

[0086] In order to monitor the internal pressure of the ventricle in real time, the transvalvular blood pump 100 also includes a first pressure sensor 1110 and a controller. The first pressure sensor 1110 is arranged at one end of the catheter 170 extending to the outside of the first one-way valve 140. A wire 1120 connected to the first pressure sensor 1110 is arranged in the catheter 170, and the controller is connected to the wire 1120.

[0087] The first pressure sensor 1110 and the controller play a very important role in the transvalvular blood pump 100. They can monitor the pressure changes in the ventricle in real time and provide feedback signals for the working state of the blood pump to ensure that the operation of the blood pump is in a safe and effective state. The first pressure sensor 1110 is usually composed of a sensing element (such as a diaphragm of the first pressure sensor 1110) and a signal conversion circuit. The sensing element will deform after sensing the pressure, and the physical change will be converted into an electrical signal through the conversion circuit. The first pressure sensor 1110 is arranged at one end of the catheter 170 extending to the outside of the first one-way valve 140. Its installation position is critical because it can accurately monitor the pressure changes when blood flows through the catheter 170. The sensor is connected to the controller through the wire 1120 to transmit the pressure data to the control system in real time. The first pressure sensor 1110 can monitor and feedback the pressure changes in the blood flow in real time, provide accurate pressure data, and help the blood pump control system optimize the working state. In addition, through the data provided by the first pressure sensor 1110, it is possible to detect in real time whether there is abnormal pressure (such as too high or too low pressure) in the blood pump system, thereby reducing the risk of failure of the blood pump or harm to the patient. The controller is composed of a microprocessor, a memory, an input / output interface, and a control module. The microprocessor is responsible for receiving and processing the signal from the first pressure sensor 1110 and determining the control strategy. The controller is connected to the first pressure sensor 1110 via a wire 1120, receives and processes the electrical signal from the sensor. The controller is also connected to other components of the blood pump (such as valves and drive systems) to adjust their working states.

[0088] Furthermore, in order to avoid interference between the wire 1120 and the pressure generating mechanism 1100, a wire tube 1130 is provided on the side of the conduit 170 extending to the outside of the first one-way valve 140, and a connecting hole is opened on the inner wall of the conduit 170 to connect the wire tube 1130 with the inside of the conduit 170. The end of the wire 1120 facing away from the first pressure sensor 1110 is inserted into the connecting hole and extends into the wire tube 1130 to be connected to the controller, and a sealing filler (not shown in the figure) is provided at the connection between the wire 1120 and the connecting hole.

[0089] In order to make the blood pump in the present application more compatible with the patients using it, a control method for the above-mentioned transvalvular blood pump 100 is specially proposed. In order to enable the transvalvular blood pump 100 to be accurately controlled, the transvalvular blood pump 100 also includes a second pressure sensor (not shown in the figure) and a flow rate sensor (not shown in the figure). The second pressure sensor is installed at the output tube 130 and connected to the controller. The flow rate sensor is installed at the output tube 130 and connected to the controller.

[0090] When the transvalvular blood pump 100 is implanted in the patient's body through interventional surgery, as described above, the second pressure sensor and flow rate sensor installed at the output tube 130 are located in the aorta to monitor the pressure and blood flow rate of the patient's aorta, while the first pressure sensor 1110 installed on the input tube 120 is used to monitor the pressure in the patient's ventricle.

[0091] like Figure 4 As shown, based on the detection of the above sensors, a control method for a transvalvular blood pump 100 includes:

[0092] Detect the patient's heart dynamic parameters.

[0093] Parameters of the first pressure sensor 1110 , the second pressure sensor and the flow rate sensor are detected respectively.

[0094] The operation of the blood pump is controlled according to the power parameters of the patient's heart, the detection parameters of the first pressure sensor 1110, the detection parameters of the second pressure sensor and the detection parameters of the flow rate sensor.

[0095] Among them, the step of "detecting the dynamic parameters of the patient's heart, specifically establishing an echocardiographic model of the patient through detection, thereby obtaining corresponding dynamic parameters" specifically includes:

[0096] Left ventricular end-diastolic volume (EDV): This is the volume of the left ventricle at the end of diastole and can be calculated using a geometric model by measuring the long and short axis diameters of the left ventricle using echocardiography.

[0097] Left ventricular end-systolic volume (ESV): This is the volume of the left ventricle at the end of systole and can also be calculated by measuring the major and minor axis diameters of the left ventricle using echocardiography and then using a geometric model.

[0098] Ejection fraction EF is an important indicator for evaluating the heart's pumping function. It indicates the percentage of blood ejected from the left ventricle to the left ventricular end-diastolic volume (EDV) each time the heart contracts. The ejection fraction EF can be obtained based on the above-mentioned cardiac dynamic parameters, specifically:

[0099]

[0100] EDV is the left ventricular end-diastolic volume, and ESV is the left ventricular end-systolic volume.

[0101] The step of respectively detecting the parameters of the first pressure sensor 1110, the second pressure sensor and the flow rate sensor is as follows: Figure 5 As shown, specifically including:

[0102] The first pressure sensor 1110 can obtain the real-time pressure in the ventricle by real-time monitoring of the pressure in the ventricle, and the following parameters can be obtained by analyzing and calculating the real-time pressure in the ventricle:

[0103] First, the ventricular pressure is monitored by the first pressure sensor 1110 to obtain a curve of the change of the ventricular pressure over time.

[0104] Heart rate: The heart rate is obtained by determining the peak and trough values ​​of the pressure during systole and diastole through the periodic changes of the ventricular pressure curve and calculating the time interval between adjacent peaks or troughs.

[0105] Rate of change of intraventricular pressure (dp / dt): Differentiate the ventricular pressure curve to obtain the pressure change rate curve over time, and you can get dp / dt. It is the rate of change of ventricular pressure over time, that is, the time derivative of pressure change. dp / dt can reflect the speed of heart contraction and relaxation, as well as the contractility of the myocardium. An increase in dp / dt may indicate an increase in myocardial contractility, while a decrease in dp / dt may indicate a decrease in myocardial contractility.

[0106] The above parameters obtained directly or indirectly are crucial for controlling the transvalvular blood pump 100 because they can help the controller understand the heart's pumping function and load conditions, thereby adjusting the operating parameters of the blood pump, such as expansion and contraction frequency and expansion and contraction strength, to suit the specific needs of the patient.

[0107] For example, if ventricular pressure increases or dp / dt decreases, it may indicate that the heart is overloaded or its contractile function is weakened. At this time, the blood pump can reduce the contraction frequency and strength to reduce the burden on the heart. On the contrary, if ventricular pressure decreases or dp / dt increases, it may indicate that the heart is underloaded or its contractile function is enhanced. At this time, the blood pump can increase the contraction frequency and strength to compensate for the insufficient blood pumping of the heart.

[0108] In summary, the first pressure sensor 1110 plays an important role in the control of the transvalvular blood pump 100. It provides key cardiac physiological parameters and helps the controller to adjust the operating parameters of the blood pump in real time to achieve the best blood circulation assistance effect.

[0109] The second pressure sensor is installed at the output tube 130. When the transvalvular blood pump 100 is implanted in the human body, the second pressure sensor is placed in the aorta together with the output tube 130. At this time, the second pressure sensor can obtain the pressure value in the aorta. With the cooperation of the first pressure sensor 1110 and the second pressure sensor, a more accurate blood pressure value of the patient can be calculated.

[0110] Peak ventricular pressure and systolic pressure: Peak ventricular pressure is usually close to systolic pressure because it is the highest pressure generated when the heart contracts. Therefore, peak ventricular pressure can be used as an approximation of systolic pressure, especially left ventricular peak pressure, which is related to systemic systolic pressure.

[0111] Aortic pressure and diastolic pressure: Aortic pressure reflects the pressure of blood on the blood vessel wall after the heart pumps blood, including systolic pressure and diastolic pressure. The second pressure sensor is placed in the aorta, which can directly measure the pressure value in the aorta, including systolic pressure and diastolic pressure.

[0112] Comprehensive assessment of blood pressure: By combining ventricular peak pressure (approximate systolic pressure) with aortic pressure (including systolic and diastolic pressure), a more comprehensive assessment of the patient's blood pressure can be made. For example, if ventricular peak pressure is high but aortic diastolic pressure is low, it may indicate that the heart is pumping well but vascular resistance is low or vasodilation is present.

[0113] In order to match the output of the transvalvular blood pump 100 with the flow rate of the blood in the aorta, a flow rate sensor should be installed at the output tube 130. When the transvalvular blood pump 100 is implanted in the human body, the flow rate sensor is placed in the aorta to monitor the flow rate of the blood in the aorta in real time.

[0114] The step of “controlling the operation of the blood pump according to the power parameters of the patient's heart, the detection parameters of the first pressure sensor 1110, the detection parameters of the second pressure sensor and the detection parameters of the flow rate sensor” specifically includes:

[0115] The expansion and contraction frequency and intensity of the blood pump are controlled through a comprehensive analysis of the real-time ventricular pressure, heart rate, rate of change of ventricular pressure, ejection fraction, pressure in the aorta (systolic and diastolic pressure) and blood flow rate in the aorta monitored or calculated in the previous steps.

[0116] First, ventricular function is assessed. Parameters such as ventricular pressure, heart rate, dp / dt, and EF are analyzed to assess ventricular contractile function and load. For example, increased ventricular pressure, increased heart rate, decreased dp / dt, and decreased EF may indicate weakened ventricular contractile function or overload.

[0117] Secondly, the aortic function is assessed. The aortic pressure and flow velocity are analyzed to assess the hemodynamic status of the aorta. For example, increased aortic pressure and increased flow velocity may indicate increased peripheral vascular resistance or increased cardiac pumping function.

[0118] The blood flow status is then evaluated. The relationship between ventricular pressure, aortic pressure, and flow rate is analyzed to evaluate the blood flow status. For example, an increase in ventricular pressure but unchanged or decreased aortic pressure may indicate obstructed blood flow or valve dysfunction.

[0119] According to the above analysis, the blood pump is controlled:

[0120] When ventricular function is weakened or overloaded, the burden on the heart can be reduced and further damage to the heart can be avoided by reducing the frequency and intensity of contraction and expansion of the blood pump.

[0121] When ventricular function is normal or the load is insufficient, the contraction and expansion frequency and intensity of the blood pump can be increased to supplement the insufficient blood pumping of the heart and increase cardiac output.

[0122] When blood flow is obstructed, the expansion and contraction frequency and strength of the blood pump can be adjusted to optimize the blood flow path and avoid blood retention or backflow.

[0123] When the valve dysfunction occurs, the expansion and contraction frequency and strength of the blood pump can be adjusted to adapt to the valve dysfunction and maintain effective blood circulation.

[0124] Therefore, in summary, the control steps of the transvalvular blood pump 100 can be summarized as follows:

[0125] First, ventricular pressure, heart rate, dp / dt, EF, aortic pressure, and flow rate are continuously monitored.

[0126] The data collected by each sensor is then transmitted to the controller in real time.

[0127] The controller then analyzes the collected data to evaluate ventricular function, aortic function and blood flow status.

[0128] Secondly, based on the analysis results, the controller formulates the corresponding blood pump control strategy, including the adjustment of the expansion and contraction frequency and intensity.

[0129] Next, the controller transmits the control instruction to the pressure generating mechanism 1100, adjusts the internal pressure of the catheter 170, drives the balloon 160 to contract or expand, and realizes the control of the expansion and contraction frequency and intensity of the blood pump.

[0130] Finally, repeat the above steps to achieve continuous and stable operation of the blood pump and make real-time adjustments according to changes in the patient's cardiac function and hemodynamic status.

[0131] The above contents described in this specification are merely examples of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in similar ways, as long as they do not deviate from the contents of the present specification or exceed the scope defined by the claims, they shall all fall within the protection scope of the present invention.

Claims

1. A transvalvular blood pump for pumping blood in a patient's heart into a blood vessel, characterized in that: include: A pump body, comprising a first accommodating space, wherein a first opening communicating with the first accommodating space and a second opening communicating with the first accommodating space are formed on a surface of the pump body; an input pipe, one end of which is connected to the first opening of the pump body; an output pipe, one end of which is connected to the second opening of the pump body; a first one-way valve, disposed at the other end of the input pipe, the first one-way valve being driven by the internal pressure of the input pipe, and the first one-way valve being configured to only allow external fluid to flow into the input pipe when the input pipe is connected to the external environment; a second one-way valve, disposed at the other end of the output pipe, the second one-way valve being driven by the internal pressure of the output pipe, and the second one-way valve being configured to only allow the fluid in the output pipe to flow to the outside when the output pipe is connected to the external environment; A capsule is disposed in the first accommodating space so that the outer surface of the capsule and the inner wall of the first accommodating space enclose a pump chamber, the capsule includes a second accommodating space, and the capsule is configured to contract or expand in the first accommodating space to change the volume of the pump chamber; a conduit, one end of which is connected to the first one-way valve and extends to the outside of the input pipe, the other end of which is connected to the second one-way valve and extends to the outside of the output pipe, a portion of the conduit between the first one-way valve and the second one-way valve is connected to the sac, and a flow channel is configured at the portion of the conduit connected to the sac so that the interior of the conduit is in communication with the second accommodation space in the sac; a third one-way valve, arranged on a side of the conduit, and located outside the pump body, the input pipe and the output pipe, the third one-way valve being driven by the internal pressure of the conduit, and the third one-way valve being configured to only allow the liquid in the conduit to flow to the outside when in a connected state; a fourth one-way valve, arranged on the side of the conduit, and located outside the pump body, the input pipe and the output pipe, the fourth one-way valve being driven by the internal pressure of the conduit, and the fourth one-way valve being configured to only allow liquid in the external environment to flow into the conduit when in a connected state; The pressure generating mechanism is connected to one end of the conduit close to the second one-way valve to adjust the internal pressure of the conduit.

2. A transvalvular blood pump according to claim 1, characterized in that: The third one-way valve and the fourth one-way valve are respectively arranged on both sides of the input pipe and the output pipe, and the distance between the third one-way valve and the input pipe is smaller than the distance between the fourth one-way valve and the input pipe.

3. A transvalvular blood pump according to claim 1, characterized in that: The third one-way valve and the fourth one-way valve are both arranged on the side of the conduit away from the output pipe, and the distance between the third one-way valve and the fourth one-way valve and the input pipe is greater than the distance between the third one-way valve and the fourth one-way valve and the output pipe.

4. A transvalvular blood pump according to claim 3, characterized in that: The distance between the third one-way valve and the output pipe is equal to the distance between the fourth one-way valve and the output pipe.

5. A transvalvular blood pump according to claim 3, characterized in that: The distance between the third one-way valve and the output pipe is smaller than the distance between the fourth one-way valve and the output pipe.

6. A transvalvular blood pump according to claim 3, characterized in that: The distance between the third one-way valve and the output pipe is greater than the distance between the fourth one-way valve and the output pipe.

7. A transvalvular blood pump according to any one of claims 1 to 6, characterized in that: The pressure generating mechanism comprises: a cylinder body, the cylinder body being connected to one end of the conduit extending to the outside of the second one-way valve, the cylinder body comprising a third accommodating space, and the third accommodating space extending along the first direction; A piston is disposed in the third accommodating space of the cylinder body and is controlled to move along the first direction, and an outer peripheral side of the piston is in contact with an inner wall of the third accommodating space to separate the third accommodating space into a first area and a second area independent of each other, and the first area is connected to the interior of the conduit.

8. A transvalvular blood pump according to any one of claims 1 to 6, characterized in that: The pressure generating mechanism comprises: a cylinder body, the cylinder body being connected to one end of the conduit extending to the outside of the second one-way valve, the cylinder body comprising a third accommodating space; A diaphragm is arranged in the third accommodating space to divide the third accommodating space into relatively independent third and fourth areas, the fourth area is connected to the conduit, and the diaphragm is configured to contract or expand when subjected to pressure so that the volume of the fourth area changes.

9. A transvalvular blood pump according to claim 8, characterized in that: Also includes: a first pressure sensor, the first pressure sensor being arranged at one end of the conduit extending to the outside of the first one-way valve, and a wire connected to the first pressure sensor being arranged in the conduit; A controller connected to the wire; A wire tube is provided on the side of the conduit extending to the outside of the first one-way valve, and a connecting hole is opened on the inner wall of the conduit to connect the wire tube with the inside of the conduit. The end of the wire facing away from the first pressure sensor passes through the connecting hole and extends into the wire tube to be connected to the controller, and a sealing filler is provided at the connection between the wire and the connecting hole.

10. A control method for a transvalvular blood pump according to claim 9, characterized in that: The blood pump further comprises: a second pressure sensor, disposed at the output pipe and connected to the controller; A flow rate sensor is arranged at the output pipe and connected to the controller; The control method comprises: Detect the patient's heart dynamic parameters; Respectively detecting parameters of the first pressure sensor, the second pressure sensor and the flow rate sensor; The operation of the blood pump is controlled according to the power parameters of the patient's heart, the detection parameters of the first pressure sensor, the detection parameters of the second pressure sensor and the detection parameters of the flow rate sensor.

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