Cardiovascular assist devices and circulatory assist systems

Abstract

The present invention belongs to the field of medical device technology and provides a cardiac circulation assist device, comprising a diaphragm pump, an interventional catheter, and a one-way valve. The diaphragm pump is provided with a blood cavity and an air cavity. The blood cavity is used to store blood, and the air cavity has a vent connected to an inflation and deflation device. The distal end of the interventional catheter has a tube port connected to the blood cavity, and the proximal end of the interventional catheter has an inlet that sequentially passes through the aorta and extends into the left ventricle. The one-way valve is provided on the interventional catheter and has a valve port. The one-way valve has a first state and a second state. When in the first state, the valve port is closed and connected to the inlet, allowing blood from the left ventricle to enter the blood cavity through the one-way valve. When the one-way valve is in the second state, the valve port is opened and connected to the tube port, so that the valve port is in communication with the aorta, allowing blood to flow into the aorta through the valve port, thereby achieving bidirectional blood circulation through a single interventional catheter. The device has a simple structure, a simple surgical procedure, and a low burden on the human body.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and more specifically, relates to a cardiac circulation assist device and a circulation assist system. Background Art

[0002] Heart failure is a syndrome of cardiac dysfunction caused by various cardiovascular diseases. This syndrome arises from a decrease in myocardial contractility, resulting in an inability of the heart's stroke volume to meet the body's metabolic needs. Simultaneously, blood pooling in the heart increases diastolic intracardiac pressure and dilates the heart chambers, further reducing myocardial contractility and exacerbating heart failure. This leads to obstructed blood return to the systemic and pulmonary circulations, congestion in both the systemic and pulmonary circulations, and circulatory dysfunction and metabolic disorders. With the advancement of coronary intervention, coronary stents have become largely domestically produced. However, high-risk PCI procedures account for approximately 10% of percutaneous coronary intervention (PCI) procedures each year. These procedures carry significant risks and high patient mortality, making them a clinical challenge that urgently needs to be addressed. High-risk PCI includes factors such as advanced age, left ventricular ejection fraction less than 35%, unprotected left main coronary artery disease, multivessel disease, and myocardial infarction with ST elevation (the segment between the QRS wave and the T wave).

[0003] With the increase in complex and high-risk patients, percutaneous mechanical circulatory support has become the fastest-growing field in diagnosis and treatment. At present, the commonly used percutaneous mechanical circulatory support devices in clinical practice include intra-aortic balloon pump (IABP, Intra-aortic balloon pump or Intraaortic Balloon Counterppulsation), extracorporeal membrane oxygenation (ECMO, extracorporeal membrane oxygenation) and percutaneous axial flow pump system. IABP is the most widely used percutaneous mechanical circulatory support device in clinical practice. It usually requires surgical incision of the blood vessels to inject the aortic balloon. Since the aortic balloon is open during diastole, this will cause the blood flow in the aorta to be suppressed. Although it is cheap and easy to operate, the blood circulation support is limited. Extracorporeal membrane oxygenation and percutaneous axial flow pump system are both axial flow pumps, which use suction blood flow to assist the heart to pump blood. Although they can effectively achieve blood assistance, they are expensive and prone to hemolysis.

[0004] Due to the defects of the above-mentioned devices, clinical practice in related technologies usually uses an extracorporeal pulsatile blood pump to assist cardiac circulation. The pulsatile blood pump can generate a pulsed blood flow similar to that generated by the beating of the human heart, and is not prone to generating high-speed blood flow to form a large shear stress, thereby reducing the occurrence of hemolysis to a certain extent. However, the existing pulsatile blood pump has complex connecting pipes and the surgical operation is relatively complicated, which places a heavy burden on the human body. Summary of the Invention

[0005] The purpose of the embodiments of the present invention is to provide a cardiac circulation assist device and a circulation assist system to solve the technical problems of the existing pulsatile blood pump, such as complicated connecting pipes and complicated surgical operations.

[0006] To achieve the above-mentioned purpose, the technical solution adopted by the present invention is to provide a cardiac circulation assist device, comprising:

[0007] A diaphragm pump, wherein the diaphragm pump is provided with a blood cavity and an air cavity separated by a flexible membrane, the blood cavity is used to store blood; the air cavity has a vent connected to an inflation and deflation device to compress or expand the blood cavity;

[0008] an interventional catheter, wherein the distal end of the interventional catheter has a tube port communicating with the blood cavity, and the proximal end of the interventional catheter sequentially passes through the aorta and extends into the left ventricle, and has an inlet corresponding to the left ventricle; and

[0009] a one-way valve, disposed on the interventional catheter, having a valve port communicating with the aorta, the one-way valve having a first state and a second state, wherein in the first state, the valve port is closed and communicated with the inlet, allowing blood from the left ventricle to enter the blood cavity;

[0010] In the second state, the valve port is opened and connected to the tube port, so that the blood in the blood cavity enters the aorta.

[0011] Optionally, the interventional catheter comprises:

[0012] a first connecting section, communicating with the blood cavity of the diaphragm pump;

[0013] a second connecting section, which is an elastic member and is connected to an end of the first connecting section away from the diaphragm pump;

[0014] a third connecting section, which is an elastic member and is connected to an end of the second connecting section away from the first connecting section; and

[0015] an inlet ball head connected to an end of the third connecting segment away from the second connecting segment, the inlet ball head being used to extend into the left ventricle, and the inlet being formed on the inlet ball head;

[0016] Wherein, the one-way valve is connected between the second connecting section and the third connecting section.

[0017] Optionally, the second connecting section comprises two layers of polymer material coatings and a nickel-titanium wire spring, wherein the nickel-titanium wire spring is located between the two layers of polymer material coatings; and / or

[0018] The third connecting section includes two layers of polymer material coatings and a nickel-titanium wire spring, and the nickel-titanium wire spring is located between the two layers of polymer material coatings.

[0019] Optionally, the third connecting member includes two parts that are bent relative to each other, and the bending angle between the two parts is 120° to 180°.

[0020] Optionally, the inlet ball head includes:

[0021] a spherical member, the spherical member being configured to extend into the left ventricle, the inlet penetrating the spherical member; and

[0022] The support structure is an elastic member connected between the spherical member and the third connecting section, and has an internal space communicating with the inlet and the third connecting section.

[0023] Optionally, the support structure includes a plurality of support rods spaced apart along the circumference of the spherical component, both ends of the support rods are respectively connected to the third connecting section and the spherical component, and an opening connected to the internal space is formed between two adjacent support rods.

[0024] Optionally, the inlet ball head further includes:

[0025] A pigtail catheter, wherein the straight section of the pigtail catheter is connected to the spherical member, and the curved section of the pigtail catheter is connected to the straight section.

[0026] The present invention also provides a circulatory assist system, comprising a device host and the above-mentioned cardiac circulatory assist device, wherein the device host comprises the inflation and deflation device, and the device host can identify electrocardiographic signals and control the inflation and deflation device to inflate or deflate the air cavity through the vent.

[0027] The present invention also provides a circulatory assist system, comprising a first sensor, a second sensor, a controller, an inflation and deflation device, and the cardiac circulatory assist device described above, wherein the first sensor is connected to the proximal end of the interventional catheter, and the first sensor is used to measure the pressure of the left ventricle; the second sensor is connected to the portion of the interventional catheter located in the aorta, and is used to measure the pressure in the aorta; the controller is electrically connected to the first sensor, the second sensor, and the inflation and deflation device, respectively, and is used to determine whether the left ventricle is in a contraction or relaxation state based on the pressure data, and to control the inflation and deflation device to inflate or exhaust the air cavity through the vent.

[0028] Optionally, the circulatory assist system further includes:

[0029] a first electrical connection line, one end of which is electrically connected to the first sensor;

[0030] a second electrical connection line, one end of which is electrically connected to the second sensor; and

[0031] The sensor tube port is provided on the interventional catheter, and the other end of the first electrical connection line and the other end of the second electrical connection line are electrically connected to the controller through the sensor tube port respectively.

[0032] The beneficial effects of the cardiac circulation assist device provided by the present invention are: the interventional catheter is passed through the left ventricle and the aorta in sequence, a one-way valve is set on the interventional catheter, and a valve port connected to the aorta is opened on the one-way valve. The one-way valve has a first state and a second state. When in the first state, the valve port is closed and connected to the inlet, so that the blood in the left ventricle enters the blood cavity through the one-way valve; and when the one-way valve is in the second state, the valve port is opened and connected to the pipe port, so that the valve port is conducted with the aorta, and blood can flow into the aorta through the valve port, thereby realizing two-way blood circulation through an interventional catheter. The structure is simple, the surgical procedure is simple, and the burden on the human body is small. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0034] Figure 1 A schematic diagram of the valve closing structure of a cardiac circulation assist device provided in an embodiment of the present invention;

[0035] Figure 2A schematic diagram of the valve opening structure of a cardiac circulation assist device provided by an embodiment of the present invention;

[0036] Figure 3 A schematic diagram of the three-dimensional structure of a cardiac circulation assist device provided in an embodiment of the present invention;

[0037] Figure 4 A schematic diagram of the three-dimensional structure of an interventional catheter and a one-way valve provided in an embodiment of the present invention;

[0038] Figure 5 A schematic diagram of the three-dimensional structure of a diaphragm pump provided in an embodiment of the present invention;

[0039] Figure 6 A schematic diagram of the three-dimensional structure of an inlet ball head provided in an embodiment of the present invention;

[0040] Figure 7 A schematic diagram of the three-dimensional structure of an imported ball head is provided for an embodiment of the present invention;

[0041] Figure 8 A schematic diagram of the three-dimensional structure of the inlet ball head and the bracket structure is provided for the first embodiment of the present invention;

[0042] Figure 9 A schematic diagram of the three-dimensional structure of the inlet ball head and the bracket structure is provided for the second embodiment of the present invention;

[0043] Figure 10 A schematic cross-sectional view of a one-way valve is provided for a first embodiment of the present invention;

[0044] Figure 11 A schematic cross-sectional view of a first embodiment of the present invention is provided in which the axis of the one-way valve shaft is concentric with the axis of the valve body;

[0045] Figure 12 A schematic cross-sectional view of a second embodiment of the present invention is provided in which the axis of the one-way valve shaft and the valve body are eccentric;

[0046] Figure 13 A schematic cross-sectional view of a bent one-way valve leaf is provided for a third embodiment of the present invention;

[0047] Figure 14 A schematic cross-sectional view of a bent one-way valve leaf is provided for a third embodiment of the present invention;

[0048] Figure 15 A schematic structural diagram of a circulation assist system is provided for a first embodiment of the present invention;

[0049] Figure 16 A schematic structural diagram of a circulation assist system is provided for a second embodiment of the present invention;

[0050] Figure 17The second embodiment of the present invention provides a pressure diagram of the left ventricle and aorta during a cardiac cycle.

[0051] Among them, the reference numerals in the figures are:

[0052] 10-diaphragm pump; 101-blood cavity; 102-air cavity; 103-vent; 104-housing;

[0053] 11-Interventional catheter; 111-First connecting section; 112-Second connecting section; 113-Third connecting section; 114-Inlet ball head; 1141-Spherical member; 1142-Stent structure; 1143-Support rod; 1144-Pigtail catheter; 1145-Curved section; 1146-Straight section; 115-Tube orifice; 116-Inlet;

[0054] 12- one-way valve; 120- valve port; 121- valve body; 122- valve leaf; 1221- first end; 1222- second end; 123- rotating shaft; 124- inclined surface;

[0055] 13-sensor nozzle;

[0056] 14-developing ring;

[0057] 2- First sensor;

[0058] 3- Second sensor;

[0059] 4-Controller;

[0060] 5-Device host;

[0061] 6-left ventricle;

[0062] 7-aorta;

[0063] a- The bending angle of the third connecting segment. DETAILED DESCRIPTION

[0064] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present invention more clearly understood, the present invention is further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0065] It should be noted that when an element is referred to as being “fixed on” or “disposed on” another element, it may be directly on the other element or indirectly on the other element. When an element is referred to as being “connected to” another element, it may be directly connected to the other element or indirectly connected to the other element.

[0066] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention.

[0067] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0068] The following are explanations of some technical terms:

[0069] An axial-flow blood pump is typically implanted in the human body, located outside the heart. The pump's outlet is connected to a prosthetic blood vessel, the other end of which is connected to the aorta. After the pump is charged with power, it is injected into the aorta through the prosthetic blood vessel. This power is a negative pressure attraction, enabling the pump to assist the heart or completely replace it. The blood flow generated by this auxiliary treatment system is a non-pulsatile, straight flow. Operating at high speeds and high flow rates, the axial-flow pump system is highly destructive to the blood, easily damaging blood cells and failing to meet physiological needs, which can easily lead to hemolysis.

[0070] Please also refer to Figure 1 、 Figure 2 and Figure 6 The cardiac circulatory assist device provided by an embodiment of the present invention will now be described. The cardiac circulatory assist device includes a diaphragm pump 10 and an interventional catheter 11. The diaphragm pump 10 is provided with a blood cavity 101 and an air cavity 102. A flexible membrane is provided in the middle of the diaphragm pump 10 to separate the blood cavity 101 and the air cavity 102. The flexible membrane can be made of a polymer material. The blood cavity 101 is used to store blood. The air cavity 102 has a vent 103 connected to an inflation / deflation device. When the inflation / deflation device inflates the air cavity 102 through the vent 103, the air cavity 102 is filled with gas, which compresses the blood cavity 101. When the inflation / deflation device deflates the air cavity 102 through the vent 103, the air cavity 102 releases gas, causing the blood cavity 101 to dilate, allowing the blood cavity 101 to be filled with blood.

[0071] See further Figure 3 and Figure 4The distal end of the interventional catheter 11 has a tube mouth 115, which is connected to the blood cavity 101 of the diaphragm pump 10, that is, it extends into the blood cavity 101, so that the blood in the blood cavity 101 can circulate through the interventional catheter 11. The proximal end of the interventional catheter 11 passes through the aorta 7 of the heart in turn and extends into the left ventricle 6. The proximal end of the interventional catheter 11 has an inlet 116 corresponding to the left ventricle, so that the blood in the left ventricle 6 can flow into the interventional catheter 11 and the blood cavity 101 in turn through the inlet 116, and then the blood cavity 101 can be filled with blood.

[0072] Further, see Figure 10 and Figure 11 The cardiac circulation assist device also includes a one-way valve 12, which is disposed on the interventional catheter 11. A valve port 120 is provided on the one-way valve 12, which is connected to the aorta 7. The one-way valve 12 can control the direction of blood flow, thereby opening or closing the valve port 120. In a first state, the valve port 120 is closed and connected to the orifice 115 of the interventional catheter 11. The flow space within the one-way valve 12 is open, allowing blood in the left ventricle 6 to flow through the orifice 115 to the one-way valve 12, a portion of the interventional catheter 11, and the blood cavity 101 in sequence. In a second state, the valve port 120 is open and connected to the inlet 116 of the interventional catheter 11. This cuts off the flow space within the one-way valve 12, allowing blood in the blood cavity 101 to flow to the aorta 7 through the inlet 116 of the interventional catheter 11 and the valve port 120, thereby achieving blood circulation through the interventional catheter 11. Its working principle is as follows:

[0073] When the heart contracts, the pressure in the left ventricle 6 increases and the pressure in the blood cavity 101 is zero. Due to the pressure difference between the left ventricle 6 and the blood cavity 101, the blood in the left ventricle 6 can be pumped into the blood cavity 101 of the diaphragm pump 10 through the interventional catheter 11. At this time, the one-way valve 12 is in an open state under the action of the pressure difference, that is, the valve port 120 is closed, thereby ensuring that the blood in the left ventricle 6 can pass through the interventional catheter 11 and the one-way valve 12 and flow smoothly into the blood cavity 101. At this time, the gas in the air cavity 102 is in a released state to ensure that the blood cavity 101 has space to store blood. When the heart is in diastole, the air cavity 102 is inflated, the gas in the air cavity 102 expands and compresses the blood cavity 101, the pressure in the blood cavity 101 increases, and the pressure in the aorta 7 is zero. Due to the pressure difference between the blood cavity 101 and the aorta 7, the one-way valve 12 is closed at this time, that is, the valve port 120 is open, and the blood in the blood cavity 101 can pass through the tube port 115 and the valve port 120 of the interventional catheter 11 and flow smoothly into the aorta 7, thereby circulating in the body.

[0074] It should be noted that the extracorporeal pulsating blood pump in the related art includes a blood storage chamber, an inlet blood vessel and an outlet blood vessel connected to the blood storage chamber, and a pulse drive device arranged in the blood storage chamber. A balloon is arranged in the blood storage chamber. Since the size of the blood storage chamber is fixed, the change in the volume of the driving balloon causes corresponding pressure changes in the blood storage chamber. When the pressure is negative or the balloon is small, the proximal valve opens and the distal valve closes. The human blood flows from the pipeline and through the proximal valve to the blood storage chamber and is stored. When the balloon is filled, the balloon expands outward, and the human blood flows from the inlet blood vessel to the blood storage chamber and is stored, and flows out through the outlet blood vessel and returns to the human body. This back and forth process makes the blood flow in and out to form a pulsating blood flow. The above-mentioned inlet blood vessel and outlet blood vessel need to be connected to different parts of the human body, and the surgical procedure is relatively complicated.

[0075] The cardiac circulation assist device in this embodiment passes the interventional catheter 11 through the left ventricle 6 and the aorta 7 in sequence, and a one-way valve 12 is provided on the interventional catheter 11. A valve port 120 connected to the aorta 7 is opened on the one-way valve 12. The one-way valve 12 has a first state and a second state. When in the first state, the valve port 120 is closed and connected to the inlet 116, so that the blood in the left ventricle 6 enters the blood cavity 101 through the one-way valve 12; and when the one-way valve 12 is in the second state, the valve port 120 is opened and connected to the tube port 115, so that the valve port 115 is connected to the aorta 7, and blood can flow into the aorta 7 through the valve port 120, thereby realizing two-way blood circulation through one interventional catheter 11. The structure is simple, the operation process is simple, and the burden on the human body is small.

[0076] It can be understood that the diaphragm pump 10 has a hard shell 104 , a flexible membrane is connected to the hard shell 104 to form a cavity, and the cavity is divided by the flexible membrane to form a blood cavity 101 and an air cavity 102 .

[0077] In one embodiment of the present invention, please refer to Figure 3 and Figure 4 The interventional catheter 11 can be made of polymer materials. The interventional catheter 11 includes a first connecting section 111 , a second connecting section 112 , a third connecting section 113 and an inlet ball head 114 .

[0078] Specifically, the first connecting section 111 is connected to and conducted with the diaphragm pump 10; the second connecting section 112 is an elastic part, such as a spring tube or other elastic component. The second connecting section 112 can be formed by a nickel-titanium wire material and a polymer material coating, wherein the nickel-titanium wire spring is wrapped by two layers of polymer material coating. The nickel-titanium wire material is a superelastic material and can still restore to its original state under large deformation. The second connecting section 112 is connected to the end of the first connecting section 111 away from the diaphragm pump 10.

[0079] The third connecting segment 113 is also an elastic part. The third connecting segment 113 is a spring tube and has good axial bending ability. It can better adapt to the heart structure, that is, it is in flexible contact with the myocardium to avoid damaging the myocardium. The third connecting segment 113 is used to pass through the aortic valve 7. The third connecting segment 113 can be formed by nickel-titanium wire material and a polymer material coating, wherein the nickel-titanium wire spring is wrapped by two layers of polymer material coating. The nickel-titanium wire material is a superelastic material and can still restore to its original state under large deformation. The third connecting segment 113 is connected and conductive to the end of the second connecting segment 112 away from the first connecting segment 111.

[0080] It should be noted that, see Figure 5 A first developing ring 14 is provided on the third connecting section 113. The developing ring 14 is made of platinum-iridium alloy. The developing ring 14 is used to determine the placement position of the entire interventional catheter 11, so that the doctor can accurately place the interventional catheter 11 in the correct position during the operation, avoiding multiple operations that take too long and may cause life-threatening situations.

[0081] The inlet ball head 114 is placed in the left ventricle 6. The inlet ball head 114 can be made of stainless steel, nickel-titanium alloy or titanium alloy. Preferably, the inlet ball head 114 is made of titanium alloy. The inlet ball head 114 is connected and conductive to the end of the third connecting section 113 away from the second connecting section 112. The inlet ball head 114 extends into the left ventricle 6, and an inlet 116 is formed on the inlet ball head 114. The front end face and the rear end face of the inlet ball head 114 are both smooth spherical structures, wherein the front end face refers to the end face close to the left ventricle 6, and the rear end face refers to the end face away from the left ventricle 6. The smooth spherical structure of the front end face can prevent the interventional catheter 11 from damaging the myocardium and arterial blood vessels during the implantation process, and the smooth spherical structure of the rear end face can prevent blood stasis, thereby preventing the formation of thrombus.

[0082] Among them, the one-way valve 12 is connected between the second connecting section 112 and the third connecting section 113, which facilitates the assembly of the interventional catheter 11 and better adapts to the structure of the ventricle and aorta 7. The one-way valve 12 is located in the aorta 7, so that the valve port 120 of the one-way valve 12 can be connected to the aorta 7.

[0083] The interventional catheter 11 in this embodiment is divided into several parts, each of which can adapt to the corresponding structure, making it easy to install the one-way valve 12, and the overall assembly efficiency is high.

[0084] It should be noted that, in other embodiments, the one-way valve 12 can be provided on the second connecting segment 112 or on the third connecting segment 113 , as long as the one-way valve 12 can be located in the aorta 7 .

[0085] Understandably, see Figure 5 The third connecting segment 113 is an elastic member, so that the third connecting segment 113 can be made into a pre-bent structure to better adapt to the position of the left ventricle 6 and the aorta 7. Specifically, the third connecting segment 113 includes two relatively bent parts, and the bending angle a between the two parts ranges from 120° to 180°. In specific applications, the bending angle a between the two parts is 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175° or 180°. Setting the bending angle of the third connecting segment 113 within the above range facilitates the placement of the third connecting segment 113 in the left ventricle 6 and the artery.

[0086] Further, see Figure 7 and Figure 8 The inlet ball head 114 includes a spherical member 1141 and a support structure 1142. The spherical member 1141 extends into the left ventricle 6 and connects to the myocardium of the left ventricle 6. The use of the spherical member 1141 prevents damage to the myocardium and arterial vessels during implantation, and also prevents blood stasis, thereby preventing the formation of thrombi. The support structure 1142 is an elastic member connected between the spherical member 1141 and the third connecting segment 113, and defines an internal space connecting the inlet 116 and the third connecting segment 113. The elastic member can be made of rubber, or alternatively, a spring. The elastic structure allows the entire interventional catheter 11 to be compressed during delivery into the human body and expand after implantation, facilitating placement within the smaller diameter aorta 7. It should be noted that the spherical member 1141 refers to a member having at least a smooth, convex surface on its front end. It can be spherical, ellipsoidal, or other similar spherical shapes.

[0087] Specifically, in one embodiment of the present invention, the support structure 1142 includes a plurality of support rods 1143 axially spaced apart along the spherical member 1141, and the two ends of the support rods 1143 are respectively connected to the third connecting segment 113 and the spherical member 1141, and an opening connecting the internal space is formed between two adjacent support rods 1143. The support structure 1142 is set as the support rods 1143 spaced apart, which can facilitate the blood flow into the interventional catheter 11 when the entrance of the spherical member 1141 is blocked by the myocardium, that is, the blood flow can enter the interventional catheter 11 through the opening between adjacent support rods 1143.

[0088] For example, see Figure 8 The support rod 1143 can be an outward convex structure, and the outward convex structure refers to the convexity away from the spherical part 1141, which further facilitates the blood to enter the interventional catheter 11.

[0089] Of course, in other embodiments, see Figure 7 and Figure 9 The support rod 1143 can be a straight structure, and the support rod 1143 is arranged parallel to the axis direction of the spherical member 1141, that is, a columnar support structure is formed.

[0090] When the device is working, in order to better protect the myocardium, a pigtail catheter 1144 can be installed. In one embodiment of the present invention, please refer to Figure 7 The inlet ball head 114 further includes a pigtail catheter 1144 , wherein the end of the pigtail catheter 1144 is curled and shaped like a pigtail.

[0091] Specifically, the straight section 1146 of the pigtail catheter 1144 is connected to the spherical member 1141, and the curved section 1145 of the pigtail catheter 1144 is connected to the straight section 1146. The pigtail catheter 1144 is made of a polymer flexible material and can protect the myocardium. In one embodiment of the present invention, further Figure 10 The one-way valve 12 is a core component that can control the direction of blood flow. The one-way valve 12 is used to connect to the interventional catheter 11. The one-way valve 12 includes a valve body 121 and a valve leaf 122. The valve body 121 is arranged between the first section and the second section of the interventional catheter 11, wherein the first section is the third connecting section 113 mentioned above, and the second section is the second connecting section 112 mentioned above. A through cavity is provided in the valve body 121, and a valve port 120 communicating with the cavity is provided on the valve body 121. The valve leaf 122 is rotatably connected to the inner wall of the valve body 121 and has a first position for opening the valve port 120 and a second position for blocking the valve port 120.

[0092] The surface of the valve leaf 122 facing away from the valve port 120 is an inclined surface 124 . When the valve leaf 122 is located at the first position, the inclined surface 124 is inclined away from the valve port 120 in the radial direction of the valve body 121 , along the direction from the first section to the second section.

[0093] It should be noted that the valve in the related art is an elastic structure and extends radially along the pipe, that is, perpendicular to the direction of blood flow. Blood and other fluids require a lot of force each time to push the valve open.

[0094] The one-way valve 12 in this embodiment is provided with an inclined surface 124, and the inclined surface 124 is set in the direction from the first section to the second section. When the valve leaf 122 is in the first position, the inclined surface 124 is inclined upward along the radial direction of the valve body 121 toward the valve port 120, thereby increasing the contact area between the blood and the valve leaf 122. Moreover, when the fluid flows from the first section to the second section, the fluid acts on the inclined surface 124, which can provide a force to rotate the valve leaf 122 toward the valve port 120, thereby making it easy for the fluid to push the valve leaf 122 to rotate toward the valve port 120 to close the valve port 120. In order to close the valve port 120, the fluid resistance is small, so that the fluid circulation is smooth, and the overall structure of the one-way valve 12 is simple and the volume is small.

[0095] It should also be noted that when it is necessary to allow the fluid to flow from the second section to the first section, in some cases, there is a pressure difference between the outside of the valve port 120 and the inside of the valve body 121. Under the action of the pressure difference, the valve leaf 122 rotates away from the valve port 120, so that the fluid pushes the valve leaf 122 to rotate in the direction away from the valve port 120, that is, the valve leaf 122 abuts against the inner wall of the valve body 121 to open the valve port 120.

[0096] The following example uses the one-way valve placed in the heart's aorta as an example:

[0097] Among them, the valve body 121 is arranged at a position of the interventional catheter 11 close to the aorta 7, and a cavity for blood circulation is provided in the valve body 121, that is, the cavity is connected with the second connecting section 112 and the third connecting section 113 of the interventional catheter 11, and the valve port 120 is arranged on the valve body 121, and the cavity can be connected with the aorta 7 through the valve port 120.

[0098] The valve leaf 122 is disposed in the valve body 121 and is rotatably connected to the inner wall of the valve body 121, thereby opening the valve port 120 or blocking the valve port 120. Figure 11 When the valve leaf 122 opens the valve port 120, the cavity can communicate with the aorta 7, see Figure 12 When the valve leaf 122 blocks the valve port 120 , the cavity of the valve body 121 is connected to the interventional catheter 11 .

[0099] It should be noted that when the heart contracts, the pressure in the left ventricle is greater than the pressure in the blood cavity. Under the action of the pressure difference, when the blood in the left ventricle 6 flows to the blood cavity 101, the blood can easily push the valve leaf 122 to rotate toward the valve port 120 and block the valve port 120; and when the heart relaxes and the blood cavity contracts, the pressure in the blood cavity is greater than the pressure in the aorta. When the blood in the blood cavity 101 flows toward the interventional catheter 11 under the action of the pressure difference, the valve leaf 122 can easily rotate in the direction away from the valve port 120 under the push of the blood, that is, the valve leaf 122 abuts against the inner wall of the valve body 121, and the valve port 120 opens, so that the blood can flow smoothly to the aorta 7 through the valve port 120.

[0100] In one embodiment of the present invention, see Figure 10 The two ends of the valve leaf 122 are respectively a first end 1221 and a second end 1222, the first end 1221 is set toward the second section (second connecting section 112), and the second end 1222 is set toward the first section (third connecting section 113), and the second end 1222 is rotatably connected to the inner wall of the valve body 121, and the cross-sectional area of ​​the first end 1221 is smaller than the cross-sectional area of ​​the second end 1222, wherein the cross-sectional area refers to the cross-sectional area set along the radial direction of the valve body 121, and the one-way valve 12 also includes a rotating shaft 123, which passes through the second end 1222 and the valve body 121 in sequence, so that the valve leaf 122 is rotatably connected to the valve body 121.

[0101] When the blood inside the blood cavity 101 is pumped into the interventional catheter 11, the blood pressure pushes the valve leaf 122 to rotate, causing the valve leaf 122 to open the valve port 120, and blood flows into the aorta 7 from the one-way valve 12; and when the blood in the left ventricle 6 flows into the blood cavity 101 to fill it, the valve leaf 122 blocks the valve port 120 to prevent blood from flowing into the aorta 7.

[0102] It should be noted that in this embodiment, the cross-sectional area of ​​the first end 1221 is set to be smaller than the cross-sectional area of ​​the second end 1222, which provides space for setting the rotating shaft 123 and enables the first end 1221 to droop toward the valve port 120 under the action of gravity, further reducing the resistance to pushing open.

[0103] In one embodiment of the present invention, see Figure 10 Along the direction of the blood cavity 101 close to the left ventricle 6, the surface of the valve leaf 122 away from the valve port 120 is adapted to the inner wall surface of the valve body 121, thereby facilitating the sealing of the valve port 120. When the valve body 121 is cylindrical, the surface of the valve leaf 122 away from the valve port 120 is a curved surface, and when the valve body 121 is a square column shape, the surface of the valve leaf 122 away from the valve port 120 is a flat surface, which can be selected according to specific needs.

[0104] In one embodiment of the present invention, see Figure 10 The axis of the rotating shaft 123 passes through the central axis of the valve body 121, that is, the rotating shaft 123 and the valve body 121 are arranged concentrically, which is convenient for installation.

[0105] Of course, in other embodiments, see Figure 12 The axis of the rotating shaft 123 may not pass through the central axis of the valve body 121, that is, the rotating shaft 123 and the valve body 121 are eccentrically arranged, wherein the axis of the rotating shaft 123 may be located above the central axis of the valve body 121. Of course, the axis of the rotating shaft 123 may be located below the central axis of the valve body 121. There is no restriction here, as long as the eccentric setting is ensured. The eccentric setting can ensure that the valve leaf 122 is unbalanced when there is no external force to open it, thereby making it easier to close the valve leaf 122, that is, the valve leaf 122 will droop toward one side under the action of its gravity, and the valve leaf 122 can close the valve body 121.

[0106] Furthermore, in order to ensure that the valve body 121 is effectively closed, a spring can be set on the rotating shaft 123. When the valve body 121 is in a closed state (that is, the valve port 120 is open), the spring is in a naturally released state. When the blood in the left ventricle 6 pushes the valve leaf 122, the spring begins to compress and accumulate force. When the heart is in a diastolic state, the pressure of the left ventricle 6 becomes low. At this time, the blood in the blood cavity 101 flows to the interventional catheter 11, and the blood cannot push open the valve leaf 122. At this time, under the action of the spring, the valve leaf 122 automatically closes, ensuring that the blood in the blood cavity 101 flows to the aorta 7.

[0107] In one embodiment of the present invention, see Figure 13 and Figure 14 In order to further increase the contact area between the blood and the valve leaf 122, the valve leaf 122 can be set to a bent structure, that is, the first end 1221 of the valve leaf 122 is set to a bent structure. Specifically, the end portion of the first end is bent and extended in the direction away from the valve port, so that when the valve leaf blocks the valve port, the end portion of the first end and the interior of the interventional catheter form an angle toward the second section (second connecting section). When the blood inside the blood cavity 101 flows toward the interventional catheter 11, the blood exerts a force on the first end 1221, causing the valve leaf 122 to generate a torque in the direction away from the valve port 120, further prompting the valve leaf 122 to close, that is, to open the valve port 120.

[0108] The angle formed between the first end and the second end is 120° to 180°. In specific applications, the angle formed between the first end and the second end is 120°, 125°, 130°, 135°, 140°, 145°, 150°, 155°, 160°, 165°, 170°, 175° or 180°. The angle formed between the first end and the second end is set within the above range to facilitate contact between blood and the terminal portion of the first end. The present invention also provides a circulatory assistance system. For further information, see Figure 6 and Figure 15 In one embodiment of the present invention, the circulatory assistance system includes a device host 5 and the above-mentioned cardiac circulatory assistance device. The device host 5 includes an inflation and deflation device, which is arranged outside the human body and connected to the diaphragm pump 10 of the cardiac circulatory assistance device. The device host 5 can identify electrocardiographic signals, thereby determining whether the heart is in a contraction or relaxation state, and then can control the inflation and deflation device to inflate the air cavity 102 through the vent, or can extract the gas in the air cavity 102. The device host 5 can be the main device of IABP.

[0109] In another embodiment of the present invention, this embodiment also provides a circulation auxiliary system, see Figure 6 and Figure 16 , it is possible to determine whether the heart is in a systolic or diastolic state by detecting pressure signals. Specifically, the circulatory assistance system includes a first sensor 2, a second sensor 3, a controller, an inflation / deflation device, and the aforementioned cardiac circulatory assistance device. The first sensor 2 is connected to the end of the interventional catheter 11 away from the diaphragm pump 10 and is used to measure the pressure in the left ventricle 6. The second sensor 3 is connected to the portion of the interventional catheter 11 located in the aorta 7 and is used to measure the pressure within the aorta 7, thereby determining whether the heart is in a systolic or diastolic state. The controller 4 is electrically connected to the first sensor 2, the second sensor 3, and the inflation / deflation device, and is used to determine whether the heart is in a systolic or diastolic state based on the pressure data and to control the inflation / deflation device to evacuate or inflate the air cavity 102 through the vent 103.

[0110] Among them, the above-mentioned circulation assistance system also includes a first electrical connection line (not shown in the figure), a second electrical connection line and a sensor tube mouth 13, one end of the first electrical connection line is electrically connected to the first sensor 2, one end of the second electrical connection line is electrically connected to the second sensor 3, and the sensor tube mouth 13 is arranged on the interventional catheter 11, and the other end of the first electrical connection line and the other end of the second electrical connection line are electrically connected to the controller 4 through the sensor tube mouth 13 respectively.

[0111] Among them, the sensor tube mouth 13 can be a hole, which facilitates the first electrical connection line and the second electrical connection line to pass through and be electrically connected to the controller; of course, the sensor tube mouth 13 can be an interface, the other end of the first electrical connection line passes through the interventional catheter 11 and is electrically connected to the interface, the other end of the second electrical connection line passes through the interventional catheter 11 and is electrically connected to the interface, and the controller 4 is connected to the interface.

[0112] Specifically, see Figure 17 , Figure 17 A pressure diagram of the left ventricle 6 and aorta 7 during a cardiac cycle is given. According to the image, it can be judged that the heart begins to contract at point a, stops contracting at point b, and enters a diastolic state. The contraction and diastolic states of the heart are judged based on the first sensor 2 and the second sensor 3 on the interventional catheter 11.

[0113] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A cardiocirculatory assist device, characterized in that: include: A diaphragm pump, wherein the diaphragm pump is provided with a blood cavity and an air cavity separated by a flexible membrane, wherein the blood cavity is used to store blood; The air cavity has a vent connected to an inflation and deflation device to compress or expand the blood cavity; an interventional catheter, wherein the distal end of the interventional catheter has a tube port communicating with the blood cavity, and the proximal end of the interventional catheter sequentially passes through the aorta and extends into the left ventricle, and has an inlet corresponding to the left ventricle; and a one-way valve, disposed on the interventional catheter, having a valve port communicating with the aorta, the one-way valve having a first state and a second state, wherein in the first state, the valve port is closed and communicated with the inlet, allowing blood from the left ventricle to enter the blood cavity; In the second state, the valve port is opened and connected to the tube port, so that the blood in the blood cavity enters the aorta; The interventional catheter comprises: a first connecting section, communicating with the blood cavity of the diaphragm pump; a second connecting section, which is an elastic member and is connected to an end of the first connecting section away from the diaphragm pump; a third connecting section, which is an elastic member and is connected to an end of the second connecting section away from the first connecting section; and an inlet ball head, connected to an end of the third connecting segment away from the second connecting segment, the inlet ball head being used to extend into the left ventricle, and having the inlet formed on the inlet ball head; Wherein, the one-way valve is connected between the second connecting section and the third connecting section.

2. The cardiocirculatory assist device according to claim 1, wherein: The second connecting section comprises two layers of polymer material coatings and a nickel-titanium wire spring, wherein the nickel-titanium wire spring is located between the two layers of polymer material coatings; and / or The third connecting section includes two layers of polymer material coatings and a nickel-titanium wire spring, and the nickel-titanium wire spring is located between the two layers of polymer material coatings.

3. The cardiocirculatory assist device according to claim 1, wherein: The third connecting section includes two parts that are bent relative to each other, and the bending angle between the two parts is 120° to 180°.

4. The cardiocirculatory assist device according to any one of claims 1 to 3, wherein: The imported ball head comprises: a spherical member, the spherical member being configured to extend into the left ventricle, the inlet penetrating the spherical member; and The support structure is an elastic member connected between the spherical member and the third connecting section, and has an internal space communicating with the inlet and the third connecting section.

5. The cardiocirculatory assist device according to claim 4, wherein: The support structure includes a plurality of support rods spaced apart along the circumference of the spherical component. Both ends of the support rods are respectively connected to the third connecting section and the spherical component. An opening connected to the internal space is formed between two adjacent support rods.

6. The cardiocirculatory assist device according to claim 4, wherein: The inlet ball head also includes: A pigtail catheter, wherein the straight section of the pigtail catheter is connected to the spherical member, and the curved section of the pigtail catheter is connected to the straight section.

7. A circulation assist system, characterized in that: The device comprises a device host and the cardiac circulation assist device according to any one of claims 1 to 6, wherein the device host comprises the inflation and deflation device, and the device host is capable of identifying electrocardiographic signals and controlling the inflation and deflation device to inflate or deflate the air cavity through the vent.

8. A circulation assist system, characterized in that: The cardiac circulation assist device comprises a first sensor, a second sensor, a controller, an inflation and deflation device, and the cardiac circulation assist device as described in any one of claims 1 to 6, wherein the first sensor is connected to the proximal end of the interventional catheter, the first sensor is used to measure the pressure of the left ventricle, the second sensor is connected to the portion of the interventional catheter located in the aorta, and is used to measure the pressure in the aorta, the controller is electrically connected to the first sensor, the second sensor, and the inflation and deflation device, respectively, and is used to determine whether the left ventricle is in a contraction or relaxation state based on the pressure data, and to control the inflation and deflation device to inflate or evacuate the air cavity through the vent.

9. The circulatory support system according to claim 8, wherein: The circulatory assistance system further comprises: a first electrical connection line, one end of which is electrically connected to the first sensor; a second electrical connection line, one end of which is electrically connected to the second sensor; and The sensor tube port is provided on the interventional catheter, and the other end of the first electrical connection line and the other end of the second electrical connection line are electrically connected to the controller through the sensor tube port respectively.

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