Catheter in aorta and ventricular assist device

Abstract

The invention discloses an in-aorta catheter and a ventricular assist device, and belongs to the technical field of medical instruments. The catheter in the aorta comprises a multi-cavity catheter body, a first cavity and a second cavity which are isolated from each other are arranged in the catheter body, a blood inlet is formed in the proximal end of the first cavity and communicated with blood in the aorta, and medium fluid flows in the second cavity and is not communicated with the blood. A bleeding part is arranged on the multi-cavity tube body and comprises a bleeding hole formed in the tube wall and a bag-shaped film located on the side, close to the heart, of the bleeding hole. When the thin film is in the first state, the thin film is not filled with the medium and covers the sealed bleeding hole, and when the thin film is in the second state, the filled medium bulges and opens the bleeding hole to enable blood to flow out. The ventricular auxiliary device further comprises a diaphragm pump and a control host, and the control host drives the diaphragm pump to suck or pump blood and controls the saccular film to expand or contract. Accurate control of blood flow is achieved through the controllable bag-shaped thin film, and effective auxiliary circulation support is provided for patients with heart diseases.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to an intra-aortic catheter and ventricular assist device. Background Technology

[0002] A ventricular assist system is a medical device system used to assist cardiac function, primarily for the treatment of heart diseases such as heart failure.

[0003] Current ventricular assist interventional systems mainly include: percutaneous ventricular assist devices (PVADs) and intra-aortic balloon pumps (IABPs). PVADs are typically inserted percutaneously through the skin (femoral artery, etc.) and then connected to the heart to assist or take over the heart's pumping function, increasing blood flow, enhancing blood perfusion, and reducing myocardial oxygen consumption. In the short term, this helps reduce ventricular load in high-risk patients undergoing percutaneous coronary intervention (PCI) and those with cardiogenic shock. The basic principle of IABP is to insert a catheter with a balloon into the descending aorta, distal to the opening of the left subclavian artery and above the opening of the renal artery. During diastole, the balloon inflates; before systole, the balloon deflates, improving hemodynamics and thus assisting the heart's pumping function.

[0004] However, existing cardiac assist circulatory systems still have significant shortcomings in blood delivery control and intravascular blood flow regulation. First, the traditional multi-lumen catheter design, with its numerous blood flow orifices on the catheter wall, increases the risk of thrombosis. Simultaneously, the complex design with multiple valves and openable / closable openings significantly increases the possibility of intravascular blood obstruction. Second, while the multiple blood lumens within existing catheters achieve unidirectional flow, the space required between the lumens for pumping blood results in a prolonged blood flow response time, affecting pumping efficiency and increasing the probability of system failure. Furthermore, the design requiring an inflatable balloon results in a larger blood contact surface area, which can easily cause blood cell damage during balloon inflating and displacement, affecting blood quality and patient safety. Most critically, current technology struggles to achieve precise pulsatile blood supply control and cannot synchronize with the physiological rhythms of cardiac contraction and relaxation, thus impacting blood supply effectiveness and overall treatment efficiency. Summary of the Invention

[0005] To address the shortcomings of existing cardiac assist systems in blood delivery control and intravascular blood flow regulation, which make it difficult to achieve precise pulsatile blood supply control and affect patient blood supply effectiveness and treatment efficiency, this paper provides an intra-aortic catheter and ventricular assist device to achieve precise pulsatile blood supply, improve patient blood supply effectiveness, and enhance the treatment efficiency and safety of cardiac assist systems.

[0006] The technical problem this invention aims to solve is that existing cardiac assist circulation systems have the following shortcomings in terms of blood delivery control and intravascular blood flow regulation: The existing technology has a large number of blood flow holes on the catheter wall, increasing the possibility of thrombosis; the catheter is designed with multiple valves and different openable / closable openings, and the complex design makes it more likely that blood in the blood vessels will be blocked; multiple cavities within the catheter require space for one cavity to be occupied due to blood pumping, and responding to blood flow takes time, thus affecting blood pumping efficiency and increasing the probability of malfunction in practical applications; the inflatable balloon structure has a larger surface area in contact with blood, which may increase the damage to blood cells caused by the mutual inflating and displacement of the balloons.

[0007] The technical solution adopted by the present invention to solve its technical problem is: to provide an intra-aortic catheter, including a multi-lumen tube body, wherein the multi-lumen tube body is provided with a first lumen and a second lumen that are isolated from each other.

[0008] The first cavity has a blood inlet at the proximal end of the multi-lumen tube for communicating with the blood in the aorta.

[0009] The second cavity is not connected to the blood, and the fluid flowing inside the second cavity is a medium fluid.

[0010] On the multi-lumen tube, a bleeding section is provided at the distal end of the blood inlet, the bleeding section including a bleeding hole and a sac-like membrane.

[0011] The bleeding hole is located on the wall of the multi-lumen tube and can connect the first lumen with the blood in the aorta.

[0012] The cystic membrane is disposed on the proximal side of the bleeding orifice, and the proximal side of the cystic membrane is connected to the wall of the multi-lumen tube and communicates with the second cavity.

[0013] The first cavity is also provided with a one-way valve, which is located at the distal end of the blood inlet or on the blood inlet, controlling that blood can only flow from the proximal end to the distal end, and cannot flow back from the distal end through the blood inlet; preferably, when the sac-like membrane is in the first state, the sac-like membrane is not filled with medium, and covers and seals the bleeding hole; when the sac-like membrane is in the second state, the filling medium in the sac-like membrane bulges and opens the bleeding hole, allowing blood to flow out into the blood vessel through the bleeding hole.

[0014] Furthermore, the number of the second cavity is one or more.

[0015] Optionally, the number of bleeding holes is one or more, and they are distributed in at least one row along the circumference of the multi-lumen tube.

[0016] Preferably, the distal end of the sac-like membrane is attached to the wall of the multi-lumen tube and communicates with the second cavity.

[0017] Furthermore, when the distal end of the sac-like membrane is attached to the outer wall of the multi-lumen tube, its morphology is a petal-like structure, with space between adjacent petal-like structures for blood flow.

[0018] Optionally, the Shore A hardness of the inner portion of the capsule-shaped film near the inner side of the multi-lumen tube is less than the Shore A hardness of the outer portion away from the multi-lumen tube; wherein the Shore A hardness of the inner portion is in the range of 30A-50A, and the Shore A hardness of the outer portion is in the range of 60A-80A.

[0019] Preferably, in the unfilled state, the ratio of the surface area of ​​the outer portion of the sac-like film away from the multi-lumen tube to the surface area of ​​the inner portion of the sac-like film near the multi-lumen tube is in the range of 1.05:1-2:1.

[0020] Furthermore, the capsule-shaped film is made of a biocompatible polymer material, which is selected from polyurethane, thermoplastic polyurethane elastomer, silicone or polyamide block copolymer.

[0021] Optionally, the inner diameter of the multi-cavity tube is in the range of 3mm-6mm; the total cross-sectional area of ​​the second cavity accounts for 5%-10% of the total cross-sectional area of ​​the multi-cavity tube.

[0022] Preferably, the present invention also provides a ventricular assist device, comprising the aforementioned intra-aortic catheter; a diaphragm pump, the diaphragm pump comprising a pump housing and a diaphragm disposed within the pump housing, the pump housing having a chamber, the chamber being divided by the diaphragm into a blood chamber and a mediator chamber; a control unit, the control unit being connected to the mediator chamber and the control unit being connected to the second cavity, the control unit being used to drive the diaphragm pump to aspirate or pump blood, and to drive the sac-like membrane to expand or contract, wherein when the mediator chamber is emptied, the sac-like membrane is in a contracted state; and when the mediator chamber is filled, the sac-like membrane is in an expanded state.

[0023] The beneficial effects of this invention are that, compared with the prior art, the precise control of the opening and closing of the bleeding holes through the inflatable sac-like membrane enables a more precise pulsatile blood supply, improving the patient's blood supply and enhancing the treatment efficiency and safety of the cardiac assist circulation system. The inflatable sac-like membrane, when not fully inflated, tightly adheres to the outer wall of the catheter, completely covering all bleeding holes to form a sealed structure. It is only opened by the control unit during a preset diastolic phase, effectively preventing blood from flowing back into the catheter lumen from the bleeding holes or continuously leaking into the interstitial space of the blood vessel wall, thereby reducing the risks of hemolysis and thrombosis. During cardiac diastole, the sac-like membrane inflates by injecting a driving medium into the second chamber, opening a ring of bleeding holes, and simultaneously activating the diaphragm pump to push temporarily stored blood through the first chamber to the descending aorta, achieving directional and controllable blood flow, significantly increasing aortic diastolic pressure and cardiac diastolic blood flow, and effectively improving perfusion of vital organs. Addressing the issue in existing catheters where blood flow is divided into multiple cavities, potentially affecting blood pumping efficiency due to the switching between these cavities, this invention features only a fixed blood flow cavity within the catheter. This ensures stable blood pumping efficiency and smoother operation, significantly reducing the probability of malfunctions. Regarding the issue of potential blood cell damage caused by balloon expansion during operation in existing technologies, this invention does not have a corresponding structure. The inserted catheter segment is smooth and uniform, preventing damage to blood vessels and blood cells. Furthermore, the inflation of the second cavity's sac-like membrane in this invention is synchronized with the delivery of the medium cavity by the diaphragm pump, achieving a perfect balance between precise timing control and high safety. This overcomes the technical shortcomings of existing technologies, such as low blood flow, high risk of hemolysis, and high probability of malfunctions. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of an aortic catheter and diaphragm pump provided in one embodiment of this application.

[0025] Figure 2 This is a side view of another aortic catheter before and after filling, provided in one embodiment of this application.

[0026] Figure 3This is a schematic diagram of the structure of another bleeding section of an intra-aortic duct provided in one embodiment of this application.

[0027] Figure 4 This is a schematic diagram of a cross-section of an intra-aortic catheter before it is filled, according to one embodiment of this application.

[0028] Figure 5 This is a schematic cross-sectional view of an aortic catheter after filling, provided as an embodiment of this application.

[0029] Figure 6 This is a schematic diagram of a ventricular assist device provided in one embodiment of this application.

[0030] Figure 7 This is a schematic diagram illustrating an application scenario of a ventricular assist device provided in one embodiment of this application.

[0031] in:

[0032] 10: Multi-lumen tube body; 101: Blood inlet; 102: Bleeding section; 1021: Bleeding hole; 1022: Capsular membrane; 103: First cavity; 104: Second cavity; 105: One-way valve; 20: Ventricular assist device; 201 Catheter; 202: Catheter tip; 203: Bleeding area; 204: Diaphragm pump; 2041: Blood chamber; 2042: Medium chamber; 2043: Diaphragm; 205: Control unit; 301: Heart; 302: Aorta; 303: Aortic arch. Detailed Implementation

[0033] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0034] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also mean including the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a specific order as described or illustrated, unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0035] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0036] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, in addition to those depicted in the figure. For example, if the device in the figure is flipped, then an element described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0037] In the description of this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0038] In the field of interventional medical devices, the end of a medical device implanted in the human or animal body that is closer to the operator is generally called the "proximal end," and the end that is farther from the operator is called the "distal end." Based on this principle, the "proximal end" and "distal end" of any component of a medical device are defined.

[0039] The technical concept of this application is as follows:

[0040] This embodiment provides an intra-aortic catheter 201, which includes a multi-lumen tube body 10, a blood inlet 101, a bleeding section 102, and a related control system.

[0041] like Figures 2 to 6 As shown, the multi-lumen tube 10 is the main structure of the catheter 201, and internally includes a first lumen 103 and a second lumen 104 that are isolated from each other. The first lumen 103 is specifically for blood flow, and a blood inlet 101 is provided at the proximal end of the multi-lumen tube 10, which communicates with the blood in the aorta 302 to form a blood inflow channel. The second lumen 104 is not connected to the blood at all and is specifically for the flow of a medium. The medium controls the filling of the sac-like membrane 1022 through the second lumen 104. The medium flowing in the second lumen can be a liquid medium such as physiological saline, or a gaseous medium such as helium, air, or inert gas. The inner diameter of the multi-lumen tube 10 is 3-6 mm, and the total cross-sectional area of ​​the second lumen 104 accounts for 5%-10% of the total cross-sectional area of ​​the multi-lumen tube 10. This design ensures sufficient space for blood flow and provides an appropriate channel for the flow of the medium.

[0042] The bleeding section 102 is located at the distal end of the blood inlet 101 and includes two key components: a bleeding orifice 1021 and a sac-like membrane 1022. The bleeding orifice 1021 is formed on the wall of the multi-lumen tube 10, connecting the first lumen 103 with the blood within the aorta 302. The bleeding orifices 1021 are arranged in a row along the circumference of the multi-lumen tube 10, with at least one orifice 1021 provided, ensuring even distribution and stability of blood flow. Each bleeding orifice 1021 is covered by the sac-like membrane 1022.

[0043] A sac-like membrane 1022 is disposed on the proximal end of the bleeding orifice 1021 and is fixed to the outer wall of the multi-lumen tube 10 using methods such as heat fusion or adhesive bonding, and communicates with the second cavity 104, allowing the medium fluid to enter the interior of the sac-like membrane 1022. The number of sac-like membranes 1022 can be one or more. When the medium inside the sac-like membrane 1022 is aspirated, it naturally adheres to the outside of the diaphragm pump 204. Since the blood near the bleeding hole 1021 is also aspirated into the diaphragm pump 204, the negative pressure generated by the fluid inside the bleeding hole 1021 simultaneously adsorbs the sac-like membrane 1022 onto the outer wall of the multi-lumen tube 10, sealing the bleeding hole 1021 and preventing blood from flowing in. When the sac-like membrane 1022 is injected with the medium, it bulges out, moving away from the bleeding hole 1021, allowing blood to flow out from the distal end towards the bleeding hole 1021. This design guides blood to flow out in a more uniform flow field, reducing turbulence, increasing arterial perfusion for the patient, and effectively relieving cardiac load.

[0044] In this embodiment, a one-way valve 105 is also provided in the first cavity 103. This one-way valve 105 is located at the distal end of the blood inlet 101 or on the blood inlet 101, controlling that blood can only flow from the proximal end to the distal end, and cannot flow back from the distal end through the blood inlet 101. That is, when the heart contracts, blood enters from the blood inlet 101 and flows into the blood chamber 2041 of the diaphragm pump 204 through the one-way valve 105, which opens only in the direction of the distal end; while when the heart relaxes, blood is squeezed out from the blood chamber 2041 and flows out from the bleeding hole 1021, providing blood supply to the patient. However, during this process, the blood is blocked by the one-way valve 105, so it can only flow out from the bleeding hole 1021 and will not flow back to the blood inlet 101, ensuring the direction of blood flow. Based on this, the one-way valve 105 can be installed in the first cavity 103 between the blood inlet 101 and the bleeding section 102, or it can be installed on the blood inlet 101. Furthermore, the one-way valve 105 can be a single piece or a multi-piece type, as long as it can control the flow of blood, and no further restrictions are imposed here.

[0045] The process of using the aortic catheter includes: the catheter is guided, and the catheter tip (i.e., the blood inlet 101) enters from the aorta 302 and is positioned in the left ventricle. The bleeding part 102 is positioned in the aorta 302, ensuring that blood is drawn from the left ventricle into the aorta 302 when the heart contracts. When the heart contracts, the medium chamber 2042 of the external diaphragm pump 204 is drawn out, causing the diaphragm to shift towards the medium chamber. The corresponding blood chamber 2041 draws blood from the inlet 101 into the first cavity 103 of the catheter. At this time, the one-way valve 105 opens, and the sac-like membrane 1022 adheres to the outer wall of the multi-lumen tube 10, sealing the bleeding hole 1021 and preventing blood from flowing in from the bleeding hole 1021. When the heart relaxes, the medium chamber 2042 of the external diaphragm pump 204 inflates, causing the diaphragm to shift towards the blood chamber. The corresponding blood chamber 2041 discharges blood, and the sac-like membrane 1022 bulges out, moving away from the bleeding hole 1021. Blood can then flow from the distal end towards the bleeding hole 1021, and the one-way valve 105 does not allow blood to flow back to the inlet 101. Therefore, blood flows from the bleeding hole 1021 to the aorta 302, providing blood supply to the patient.

[0046] The sac-like membrane 1022 is made of a biocompatible polymer material, such as polyurethane, thermoplastic polyurethane elastomer, silicone, or polyamide block copolymer. To optimize deformation performance, its inner side (closer to the tube body) has a Shore hardness of 30A–50A, and its outer side (exposed to blood flow) has a Shore hardness of 60A–80A, making the membrane easy to adhere to the tube wall and resistant to blood flow erosion. In the unfilled state, the ratio of the outer surface area to the inner surface area is 1.05:1 to 2:1, ensuring effective opening of the bleeding orifice 1021 upon filling.

[0047] In a preferred embodiment, such as Figure 2As shown, the multi-lumen tube 10 is the main structure of the catheter 201, and internally includes a first lumen 103 and a second lumen 104 that are isolated from each other. The first lumen 103 is specifically for blood flow, and a blood inlet 101 is provided at the proximal end of the multi-lumen tube 10, which communicates with the blood in the aorta 302 to form a blood inflow channel. The second lumen 104 is not connected to the blood at all and is specifically for the flow of a medium. The medium controls the filling of the sac-like membrane 1022 through the second lumen 104. The medium flowing in the second lumen can be a liquid medium such as physiological saline, or a gaseous medium such as helium, air, or inert gas. The inner diameter of the multi-lumen tube 10 is 4.5 mm, and the total cross-sectional area of ​​the second lumen 104 accounts for 20% of the total cross-sectional area of ​​the multi-lumen tube 10. This design ensures sufficient space for blood flow and provides an appropriate channel for the flow of the medium.

[0048] The bleeding section 102 is located at the distal end of the blood inlet 101 and includes two key components: a bleeding orifice 1021 and a sac-like membrane 1022. The bleeding orifice 1021 is formed on the wall of the multi-lumen tube 10, connecting the first lumen 103 with the blood within the aorta 302. The bleeding orifices 1021 are arranged in a row along the circumference of the multi-lumen tube 10, with at least one orifice 1021 provided, ensuring even distribution and stability of blood flow. Each bleeding orifice 1021 is covered by the sac-like membrane 1022.

[0049] A sac-like membrane 1022 is positioned proximal to the bleeding orifice 1021 and is fixed to the outer wall of the multi-lumen tube 10 using methods such as heat fusion or adhesive bonding. The distal end of the sac-like membrane 1022 also adheres to the outer wall of the multi-lumen tube 10. At this point, the proximal and / or distal ends of the sac-like membrane 1022 are connected to the second cavity 104, allowing the fluid to enter the interior of the sac-like membrane 1022 and form a complete fluid flow loop. However, the number of sac-like membranes 1022 must be greater than one. The sac-like membrane 1022 has a petal-like structure with spaces between the petals for blood flow. This design avoids excessive obstruction of blood flow by the membrane. This design guides blood to flow out in a more uniform flow field, reducing turbulence.

[0050] The capsule-shaped membrane 1022 employs a layered hardness design, with a Shore A hardness of 50A for the inner portion near the multi-lumen tube 10 and a Shore A hardness of 70A for the outer portion away from the multi-lumen tube 10. This hardness gradient design allows for better control of the deformation direction and degree during membrane filling. In the unfilled state, the surface area ratio of the outer portion of the capsule-shaped membrane 1022 away from the multi-lumen tube 10 to the surface area of ​​the inner portion near the multi-lumen tube 10 is 1.2:1. This area ratio design ensures that the membrane can effectively open the bleeding pores 1021 during filling.

[0051] The capsule-shaped membrane 1022 is made of polyurethane, a material with excellent biocompatibility and elasticity, capable of withstanding repeated filling and contraction without fatigue failure.

[0052] In a preferred embodiment, the multi-lumen tube 10 is the main structure of the catheter 201, and internally comprises a first cavity 103 and a second cavity 104 that are isolated from each other. The first cavity 103 is specifically for blood flow, and a blood inlet 101 is provided at the proximal end of the multi-lumen tube 10, which communicates with the blood in the aorta 302 to form a blood inflow channel. The second cavity 104 is not in communication with the blood and is specifically for the flow of a medium. The medium controls the filling of the sac-like membrane 1022 through the second cavity 104. The medium flowing within can be a liquid medium such as physiological saline, or a gaseous medium such as helium, air, or an inert gas. In this embodiment, the number of second cavities 104 can be set to multiple. Multiple second cavities 104 can control a single sac-like membrane 1022 flap, or they can independently control different flaps of the sac-like membrane 1022, aiming to provide more precise control and make the sac-like membrane 1022 respond more quickly.

[0053] Furthermore, the inner diameter of the multi-lumen tube 10 is 4.5 mm, and the total cross-sectional area of ​​the second cavity 104 accounts for 20% of the total cross-sectional area of ​​the multi-lumen tube 10. This design not only ensures sufficient space for blood flow but also provides an appropriate channel for medium flow.

[0054] In another preferred embodiment, the capsule-shaped film 1022 may also be made of silicone or a thermoplastic polyurethane elastomer material, which also have good biocompatibility and mechanical properties.

[0055] The working principle of this intra-aortic catheter is as follows: When the medium in the second cavity 104 is withdrawn, the sac-like membrane 1022 is not filled with medium. The membrane adheres to the surface of the multi-lumen tube 10, completely covering and sealing the bleeding orifice 1021. At this time, blood cannot flow out from the first cavity 103, and the sac-like membrane 1022 is in its first state. When the medium fluid is pumped into the second cavity 104, the sac-like membrane 1022 changes to its second state. The membrane is filled with medium and bulges outward, opening the bleeding orifice 1021, allowing blood to flow out from the first cavity 103 into the blood vessel through the bleeding orifice 1021, providing blood supply to the patient.

[0056] By precisely controlling the timing of the filling and withdrawal of the medium, the catheter 201 can synchronize with the patient's heart rhythm. During diastole, it fills the membrane to open the bleeding orifice 1021 to supply blood, and during systole, it withdraws the medium to close the bleeding orifice 1021, thus achieving the function of assisted circulation. This design effectively solves the problem of inaccurate blood flow control in traditional catheters, improving the efficiency and safety of assisted blood supply.

[0057] Another preferred embodiment of this application, such as Figures 4 to 5 As shown, an intra-aortic catheter is provided, the catheter 201 including a multi-lumen tube body 10, a blood inlet 101, and a bleeding section 102.

[0058] The multi-lumen tube 10 has a composite cavity structure, including a first cavity 103 and a second cavity 104. The first cavity 103 serves as a blood channel for blood extraction and pumping; the second cavity 104 serves as a medium channel, connected to the external host unit, for medium filling and extraction. One or more bleeding holes 1021 are provided on the wall of the multi-lumen tube 10, and these bleeding holes 1021 are distributed circumferentially along the tube body, forming one or more concentric rings.

[0059] A sac-like membrane 1022 surrounds the proximal end of the bleeding orifice 1021, and this membrane has a special double-ended connection structure. The proximal end of the sac-like membrane 1022 is connected to the multi-lumen tube 10 and communicates with the second cavity 104, ensuring that the medium can enter the interior of the membrane. The distal end of the sac-like membrane 1022 is attached to the wall of the multi-lumen tube 10 and is also connected to the second cavity 104, forming a closed medium circulation loop. This double-ended connection design allows the medium to form a stable pressure distribution within the membrane, ensuring that the membrane can be uniformly filled and contracted.

[0060] When the distal end of the sac-like membrane 1022 adheres to the outer wall of the multi-lumen tube 10, its morphology is a valve-like structure. Each valve-like structure corresponds to one or more bleeding orifices 1021, and a certain gap is maintained between adjacent valve-like structures to form a space for blood flow. This valve-like structure design has important hydrodynamic significance: when the membrane is not inflated, the valve-like structures adhere tightly to the tube wall, effectively sealing the bleeding orifices 1021; when the membrane is inflated, the valve-like structures bulge outward, opening the bleeding orifices 1021, while the space between adjacent valve-like structures provides a smooth flow channel for blood.

[0061] The device works as follows: The external host controls the filling and extraction of the medium in the second cavity 104 according to the rhythm of the patient's pulse. When the medium is extracted, the sac-like membrane 1022 contracts and adheres to the tube wall, and the valve-like structure closes the bleeding hole 1021. At this time, the diaphragm pump 204 draws blood through the first cavity 103, and the one-way valve 105 opens, allowing the blood to pass smoothly through the first cavity 103 and accumulate in the blood chamber 2041. When the medium is filled, the sac-like membrane 1022 bulges, the valve-like structure opens the bleeding hole 1021, the blood is blocked by the one-way valve 105, and then flows out from the bleeding hole 1021 into the aorta 302 through the flow space between adjacent valve-like structures, providing blood supply to the patient.

[0062] The design of the distal end of the valve-like structure closely adhering to the tube wall ensures uniform pressure transmission, avoiding problems such as excessive local expansion or insufficient contraction of the membrane. Simultaneously, the flow space design between the valve-like structures optimizes the hydrodynamic characteristics of blood flow, reduces blood flow resistance, and improves blood delivery efficiency. This structural design enables the entire device to provide stable and reliable blood circulation support during application.

[0063] One embodiment of this application, such as Figure 6 As shown, a ventricular assist device 20 is also provided, which includes an intra-aortic catheter, a diaphragm pump 204, and a control unit 205.

[0064] The intra-aortic catheter employs the structure described in any of the above embodiments, including key components such as a multi-lumen tube body 10, an inlet 101, and a bleeding section 102. The multi-lumen tube body 10 contains a first cavity 103 and a second cavity 104 that are isolated from each other. The first cavity 103 has an inlet 101 at its proximal end for communication with blood within the aorta 302. The second cavity 104 is not connected to blood and contains a fluid medium. The bleeding section 102 is located distal to the inlet 101 and includes a bleeding hole 1021 formed on the wall of the multi-lumen tube body 10 and a sac-like membrane 1022 located proximal to the bleeding hole 1021. The sac-like membrane 1022 is connected to the second cavity 104. When the sac-like membrane 1022 is not filled with a medium, it covers and seals the bleeding hole 1021. When the sac-like membrane 1022 is filled with a medium and bulges, it opens the bleeding hole 1021 to allow blood to flow out into the blood vessel, thereby achieving effective blood transport.

[0065] The diaphragm pump 204 is the power component of the ventricular assist device 20, comprising a pump housing and a diaphragm 2043 within the pump housing. The pump housing has a chamber, which is divided by the diaphragm 2043 into two independent working areas: a blood chamber 2041 and a medium chamber 2042. The blood chamber 2041 is connected to the first cavity 103 of the aortic catheter, forming a blood circulation loop, enabling the suction and pumping of blood. The medium chamber 2042 serves as the driving chamber of the diaphragm pump 204, driving the diaphragm 2043 to move through changes in medium pressure, thereby compressing and expanding the blood chamber 2041. The diaphragm 2043 is made of a flexible material, possessing good elasticity and fatigue resistance, capable of withstanding long-term reciprocating motion without damage, ensuring the long-term stable operation of the device.

[0066] The control unit 205 is the central control hub of the entire ventricular assist device 20, possessing dual connectivity. The control unit 205 is connected to the media chamber 2042 of the diaphragm pump 204, driving the diaphragm 2043 to move by injecting or withdrawing media into the media chamber 2042, thereby controlling the diaphragm pump 204 to aspirate or pump blood. Simultaneously, the control unit 205 is directly or indirectly connected to the second lumen 104 of the aortic catheter, used to drive the expansion or contraction of the sac membrane 1022. The control unit 205 incorporates a sophisticated pressure control system and a timing control system, capable of precisely controlling the flow of media fluid according to the patient's heart rhythm and blood flow requirements, ensuring the device's operation is highly synchronized with the patient's physiological state, and can be adjusted according to the specific circumstances of different patients.

[0067] The working principle of the ventricular assist device 20 involved in this application is based on the coordinated control of the media chamber 2042 and the sac membrane 1022. When the media chamber 2042 is emptied, the diaphragm pump 204 is in a suction state, and at the same time, the sac membrane 1022 is in a contracted state. The membrane adheres to the surface of the catheter 201, covering the bleeding hole 1021, preventing blood from flowing out of the catheter 201. At this time, blood is drawn into the first chamber 103 through the blood inlet 101 and stored in the blood chamber 2041 of the diaphragm pump 204. When the media chamber 2042 is filled, the diaphragm pump 204 switches to a pumping state. The medium pressure pushes the diaphragm 2043 to compress the blood chamber 2041, and at the same time, the sac membrane 1022 is in an inflated state. The membrane bulges and opens the bleeding hole 1021, allowing the stored blood to be pumped into the aorta 302 through the bleeding hole 1021, providing circulatory support for the patient.

[0068] The control unit 205 synchronizes the emptying and filling of the media chamber 2042 with the patient's heart rhythm through precise timing control. During diastole, the control unit 205 empties the media chamber 2042, the diaphragm pump 204 draws blood and causes the sac-like membrane 1022 to adhere tightly, closing the bleeding orifice 1021. During systole, the control unit 205 fills the media chamber 2042 with media, the diaphragm pump 204 pumps blood and opens the bleeding orifice 1021 to supply blood to the aorta 302. This counterpulsation mode reduces the burden on the heart during systole and increases coronary perfusion during diastole, effectively improving the patient's blood circulation.

[0069] The entire ventricular assist device 20, through the coordinated operation of the diaphragm pump 204, the control unit 205, and the aortic catheter 201, achieves precise control of blood flow and assisted circulation, providing effective mechanical circulatory support for patients with heart failure.

[0070] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An intra-aortic catheter, characterized in that, include: A multi-lumen tube body, wherein the multi-lumen tube body is provided with a first cavity and a second cavity that are isolated from each other; The first cavity has a blood inlet at the proximal end of the multi-lumen tube for communicating with the blood in the aorta; The second cavity is not connected to the blood, and the fluid flowing inside the second cavity is a medium fluid; On the multi-lumen tube, a bleeding section is provided at the distal end of the blood inlet, the bleeding section including a bleeding hole and a sac-like membrane; The bleeding hole is located on the wall of the multi-lumen tube and can connect the first lumen with the blood in the aorta. The cystic membrane is disposed on the proximal side of the bleeding hole, and the proximal side of the cystic membrane is connected to the wall of the multi-lumen tube and communicates with the second cavity; The first cavity is also provided with a one-way valve, which is located at the distal end of the blood inlet or on the blood inlet, and controls the blood to flow only from the proximal end to the distal end, and not to flow back from the distal end through the blood inlet. When the cystic membrane is in the first state, the cystic membrane is not filled with a medium and covers and seals the bleeding hole; When the sac-like membrane is in the second state, the filling medium inside the sac-like membrane bulges and opens the bleeding hole, allowing blood to flow out into the blood vessel through the bleeding hole.

2. The aortic catheter as described in claim 1, characterized in that, The number of the second cavity is one or more.

3. The aortic catheter as described in claim 1 or 2, characterized in that, The number of bleeding holes is one or more, and they are distributed in at least one row along the circumference of the multi-lumen tube.

4. The aortic catheter as described in claim 1, characterized in that, The distal end of the sac-like membrane is attached to the wall of the multi-cavity tube and is connected to the second cavity.

5. The aortic catheter as described in claim 4, characterized in that, When the distal end of the sac-like membrane is attached to the outer wall of the multi-lumen tube, its morphology is a petal-like structure, with space between adjacent petal-like structures for blood flow.

6. The aortic catheter as described in claim 1, characterized in that, The Shore A hardness of the inner portion of the sac-like film near the inner side of the multi-lumen tube is less than that of the outer portion away from the multi-lumen tube; wherein the Shore A hardness of the inner portion is in the range of 30A-50A, and the Shore A hardness of the outer portion is in the range of 60A-80A.

7. The aortic catheter as described in claim 1, characterized in that, In the unfilled state, the ratio of the surface area of ​​the outer portion of the sac-like membrane away from the multi-lumen tube to the surface area of ​​the inner portion of the sac-like membrane near the multi-lumen tube is in the range of 1.05:1-2:

1.

8. The aortic catheter as described in claim 1, characterized in that, The capsule-shaped film is made of a biocompatible polymer material, which is selected from polyurethane, thermoplastic polyurethane elastomer, silicone or polyamide block copolymer.

9. The aortic catheter as described in claim 1, characterized in that, The inner diameter of the multi-cavity tube ranges from 3mm to 6mm; the total cross-sectional area of ​​the second cavity accounts for 5% to 10% of the total cross-sectional area of ​​the multi-cavity tube.

10. A ventricular assist device, characterized in that, include: The aortic catheter as described in any one of claims 1 to 9; A diaphragm pump, the diaphragm pump comprising a pump housing and a diaphragm disposed within the pump housing, the pump housing having a chamber divided by the diaphragm into a blood chamber and a medium chamber; The control host is connected to the medium cavity and the second cavity. The control host is used to drive the diaphragm pump to aspirate or pump blood, and to drive the sac-like membrane to expand or contract. When the medium cavity is emptied, the sac-like membrane is in a contracted state; when the medium cavity is filled, the sac-like membrane is in an expanded state.

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