Filling type catheter and ventricular auxiliary device
By designing a fillable catheter and coordinating the control of a diaphragm pump, the problems of inaccurate blood delivery and low safety in cardiac assist circulation systems have been solved, achieving precise pulsatile blood supply and improving the treatment efficiency and safety of cardiac assist circulation systems.
Patent Information
- Application Number
- CN202512042266.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-31
- Publication Date
- 2026-02-13
AI Technical Summary
Existing cardiac assist circulation systems have problems such as complex structure leading to high risk of thrombosis, low blood pumping efficiency, inaccurate blood flow, and damage to blood cells in terms of blood delivery control and intravascular blood flow regulation.
Design an inflatable catheter comprising a multi-lumen tube body, a one-way valve, and an inflatable balloon. The opening and closing of the balloon is controlled by a medium to achieve precise pulsatile blood supply. Combined with a diaphragm pump and a control unit, blood and medium are synchronously regulated.
It improves blood delivery efficiency and safety, reduces the risk of thrombosis and blood cell damage, and achieves precise blood supply synchronized with cardiac contraction and relaxation.
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Figure CN121513344A_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical devices, in particular to a fillable catheter and a ventricular assist device. BACKGROUND
[0002] The ventricular assist intervention system is a medical device system for assisting heart function, mainly used for assisting the treatment of heart failure and other heart diseases.
[0003] The current ventricular assist intervention system mainly includes a percutaneous ventricular assist device (PVAD) and an intra-aortic balloon pump (IABP). The PVAD is usually inserted into the body (such as the femoral artery) through the skin (percutaneously), and then connected to the heart to help or take over the blood pumping function of the heart, increase blood flow, enhance blood perfusion, reduce myocardial oxygen consumption, and help high-risk percutaneous coronary intervention (PCI) and cardiogenic shock patients reduce ventricular load in the short term. The basic principle of IABP is to implant a catheter with a balloon into the descending aorta inside the distal opening of the left subclavian artery and above the renal artery opening. In diastole, the balloon is inflated; before the heart contracts, the balloon is deflated, achieving the effect of improving hemodynamics and assisting the heart to pump blood.
[0004] However, the existing heart assist circulation system still has significant deficiencies in blood delivery control and intravascular blood flow regulation. First, in the traditional multi-lumen catheter design, the complex structure of the catheter increases the risk of thrombosis, and the complex multi-valve and openable opening design significantly increases the possibility of intravascular blood stasis. Second, although the multiple blood lumens in the existing catheter achieve unidirectional flow, the lumens need to occupy space to achieve blood pumping, which prolongs the blood flow response time, affects the blood pumping efficiency, and increases the system failure probability. In addition, in some existing technical designs of axial flow pumps, the high-speed rotating pump blades can easily cause blood cell damage, affecting blood quality and patient safety. Most importantly, the existing technology is difficult to achieve precise pulsatile blood supply control, and cannot be synchronized with the physiological rhythm of heart contraction and diastole, thereby affecting the blood supply effect on patients and overall treatment efficiency. SUMMARY
[0005] In order to solve the technical problems of the existing heart auxiliary circulation system in blood delivery control and intravascular blood flow regulation, it is difficult to achieve precise pulsatile blood supply control, which affects the blood supply effect and treatment efficiency of the patient, and to achieve precise pulsatile blood supply, improve the blood supply effect of the patient, and improve the treatment efficiency and safety of the heart auxiliary circulation system, a fillable catheter and a ventricular assist device are provided.
[0006] The technical problems to be solved by the present application are that the existing heart auxiliary circulation system has the following deficiencies in blood delivery control and intravascular blood flow regulation: the structure of the existing catheter is complex, which increases the possibility of thrombosis; the catheter is designed with multiple valves and different openable openings, and the complex design makes the possibility of blood stasis in the blood vessel higher; the space occupied by the multiple cavities in the catheter for blood pumping needs to occupy the space of another cavity, and a certain time is needed to respond to blood flow, and the multiple blood cavities affect the blood pumping efficiency, increasing the probability of failure in actual application; in some existing technical design of axial flow pump, the high-speed rotating pump blade is easy to cause blood cell damage, affecting blood quality and patient safety.
[0007] The technical solution adopted by the present application to solve the technical problems is to provide a fillable catheter, comprising a multi-cavity tube body, wherein the multi-cavity tube body is provided with a first cavity and a second cavity which are isolated from each other.
[0008] The first cavity is provided with a blood inlet at the proximal end of the multi-cavity tube body for communicating with the blood in the aorta.
[0009] The second cavity does not communicate with blood, and the medium fluid flows in the second cavity.
[0010] The distal end of the blood inlet on the multi-cavity tube body is provided with a blood outlet, and the blood outlet comprises a blood outlet hole and a balloon.
[0011] The blood outlet hole is opened on the tube wall of the multi-cavity tube body and can communicate the first cavity with the blood in the aorta.
[0012] The balloon is arranged on the proximal end side of the blood outlet hole, the proximal end side of the balloon-shaped membrane is connected with the tube wall of the multi-cavity tube body and communicates with the second cavity.
[0013] The balloon is positioned on the outer wall of the tube corresponding to the bleeding orifice. Both the proximal and distal ends of the balloon are connected to the wall of the multi-lumen tube via a supporting flow tube, and are also connected to the second cavity. The inflation and deflation of the medium within the balloon can be controlled via the flow tube. A one-way valve is also provided in the first cavity, located at the distal end of the blood inlet or on the blood inlet itself, controlling the flow of blood only from the proximal end to the distal end, preventing backflow through the blood inlet. Preferably, when the balloon is in the first state, the filling medium inflates, blocking and sealing the bleeding orifice. When the balloon is in the second state, it is not filled with medium and, supported by the flow tube, moves away from and opens the bleeding orifice, allowing blood to flow out into the blood vessel through the bleeding orifice.
[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] Furthermore, the number of balloons may be one or more, but in the first state, they can completely cover and block the bleeding hole.
[0017] Furthermore, the one-way valve can be a single-piece valve or a multi-piece valve, controlling blood flow only from the proximal end to the distal end.
[0018] Optionally, the flow tube has a certain supporting function, so that the balloon is away from the bleeding hole in the second state. Therefore, the Shore A hardness of the flow tube is in the range of 60A-80A.
[0019] Preferably, the material of the flow tube can be pebax, TPU, or a composite material of two or more materials with good biocompatibility.
[0020] Furthermore, the balloon is made of a biocompatible polymer material selected from polyurethane, thermoplastic polyurethane elastomer, polyamide, polyamide block copolymer or silicone.
[0021] Optionally, the inner diameter of the multi-cavity tube is in the range of 3mm-5mm; the total cross-sectional area of the second cavity accounts for 2%-10% of the total cross-sectional area of the multi-cavity tube.
[0022] Preferably, the present application further provides a ventricular assist device, comprising the inflatable conduit as described above; a diaphragm pump, the diaphragm pump comprising a pump shell and a diaphragm in the pump shell, the pump shell having a chamber, the chamber being divided into a blood cavity and a medium cavity by the diaphragm; a control host connected with the medium cavity and the second cavity, the control host being used to drive the diaphragm pump to suck or pump blood and to drive the balloon to inflate or deflate, but the inflation of the medium cavity is opposite to the inflation state of the balloon, when the medium cavity is evacuated, the balloon is in the inflation state; when the medium cavity is inflated, the balloon is in the deflation state.
[0023] The present application has the beneficial effect that, compared with the prior art, the opening and closing of the bleeding holes are adjusted by precise control of the inflatable balloon, more accurate pulsatile blood supply can be provided, the blood supply effect of the patient is improved, and the treatment efficiency and safety of the heart assist circulation system are improved. The inflatable balloon is inflated and adheres to the outer edge of the bleeding hole in the inflation state, completely covers each bleeding hole, forms a sealed structure, and the bleeding hole is only opened by the control host due to the deflation of the balloon at the preset diastolic period, effectively avoiding the reverse flow of blood from the bleeding hole into the conduit cavity or continuous leakage to the blood vessel wall gap, thereby reducing the risk of hemolysis, thrombus formation, etc. During the diastolic period of the heart, the medium is extracted from the second cavity to deflate the inflatable balloon, and then the bleeding hole is opened due to the support of the flow tube away from the bleeding hole, and the diaphragm pump is started synchronously to push the temporarily stored blood to the descending aorta through the first cavity, realizing directional and controllable blood flow, significantly improving the aortic diastolic pressure and blood flow during the diastolic period of the heart, and effectively improving the perfusion of important organs. In view of the problem that the blood in the prior art conduit is divided into cavities in the conduit, which may affect the blood pumping efficiency due to the conversion of multiple cavities in the conduit, the present application only provides a fixed blood flow cavity in the conduit, so the blood pumping efficiency is stable, and in actual use, it is also more stable, which can greatly reduce the probability of failure. In view of the problem that the complex structure design or axial flow pump type high-speed rotating pump blade in the prior art may cause blood cell damage, the structure design of the present application is simple and will not cause damage to blood vessels and blood cells. The inflation of the inflatable balloon of the present application is matched with the cardiac cycle of the patient, so that precise timing control and high safety can be realized, and the technical defects of small blood flow, high risk of hemolysis, and high probability of failure in the prior art are overcome. BRIEF DESCRIPTION OF DRAWINGS
[0024] Fig. 1 A structure schematic diagram of an inflatable conduit and an extracorporeal diaphragm pump is provided for an embodiment of the present application.
[0025] Fig. 2 A cross-sectional structure schematic diagram of an inflatable conduit and a diaphragm pump is provided for an embodiment of the present application.
[0026] Fig. 3 A structure schematic diagram of a fillable catheter in a filling state according to an embodiment of the present application.
[0027] Fig. 4 A structure schematic diagram of a fillable catheter in a non-filling state according to an embodiment of the present application.
[0028] Fig. 5 A structure schematic diagram of a ventricular assist device according to an embodiment of the present application.
[0029] Fig. 6 An application scenario schematic diagram of a fillable catheter according to an embodiment of the present application.
[0030] Wherein:
[0031] 10: multi-lumen tube; 101: blood inlet; 102: blood outlet; 1021: blood outlet hole; 1022: balloon; 1023: flow tube; 103: first lumen; 104: second lumen; 105: one-way valve; 20: ventricular assist device; 201: catheter; 202: catheter front end; 203: blood outlet area; 204: diaphragm pump; 2041: blood lumen; 2042: medium lumen; 2043: diaphragm; 205: control host; 301: heart; 302: aorta; 303: aortic arch. DETAILED DESCRIPTION
[0032] Exemplary embodiments of the present disclosure will be described herein below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it is understood that the present disclosure can be implemented in various forms and should not be limited by 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 present disclosure to those skilled in the art.
[0033] It should be understood that the terms used herein are for the purpose of describing particular example embodiments only and are not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and "has" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their description or illustration in a particular order except if expressly specified otherwise. It is also to be understood that additional or alternative steps can be employed.
[0034] Although the terms first, second, third, etc. can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be only used to distinguish one element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first", "second" and the like used herein do not imply a sequence or an order, but are used to distinguish one element, component, region, layer or section from another element, component, region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of example embodiments.
[0035] Spatially relative terms, such as "inner", "outer", "inward", "outward", "lower", "bottom", "top", "upper", and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms can be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the example term "below" can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
[0036] In the description of the present application, unless otherwise clearly indicated and limited, the terms "mount", "connect", "connection", "fixed", "fixedly connected" should be understood broadly, for example, can be fixed connection, can also be detachable connection, or integral; can be mechanical connection, can also be electrical connection; can be direct connection, can also be indirect connection through intervening medium, can be internal communication of two elements or interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.
[0037] In the field of interventional medical devices, the end of a medical device implanted in a human or animal body closer to an operator is generally referred to as the "proximal end", and the end farther away from the operator is referred to as the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined according to this principle.
[0038] The following is the inventive concept of the present application: The present embodiment provides a fillable catheter, which includes a multi-lumen tube 10, a blood inlet 101, a blood outlet 102, a first lumen 103, and a second lumen 104.
[0039] As Figs. 1-2 shown, the multi-lumen tube body 10 is the main structure of the catheter 201, and is internally provided with a first lumen 103 and a second lumen 104 which are isolated from each other. The first lumen 103 is specially used for blood flow, and is provided with a blood inlet 101 at the proximal end of the multi-lumen tube body 10, which is in communication with the blood in the aorta to form a blood inflow channel. The second lumen 104 is completely not in communication with the blood, and is specially used for the flow of a medium, which realizes the inflation control of the balloon 1022 through the second lumen 104. The medium flowing in the second lumen 104 can be a liquid medium such as normal saline, or a gas medium such as helium, air, inert gas, etc. The inner diameter of the multi-lumen tube body 10 is 4-5 mm, and the total cross-sectional area of the second lumen 104 accounts for 2%-10% of the total cross-sectional area of the multi-lumen tube body 10. This design not only ensures sufficient space for blood flow, but also provides a proper channel for the flow of the medium.
[0040] The bleeding part 102 is provided at the distal end of the blood inlet 101, and includes three key components: a bleeding hole 1021, a balloon 1022, and a flow-through tube 1023. The bleeding hole 1021 is formed in the wall of the multi-lumen tube body 10 and can communicate the first lumen 103 with the blood in the aorta 302. The bleeding holes 1021 are distributed in a row along the circumference of the multi-lumen tube body 10, and the number of bleeding holes 1021 is at least one, which are uniformly distributed to ensure the stability and uniformity of blood outflow. Each bleeding hole 1021 is ensured to be covered by the inflated balloon 1022.
[0041] The balloon 1022 is provided outside the wall of the multi-lumen tube body at the corresponding position of the bleeding hole 1021, and the proximal end side and the distal end side of the balloon are connected together with the wall of the multi-lumen tube body through the flow-through tube having a certain supporting effect, and the connection mode includes but is not limited to heat fusion, adhesion and other fixing modes, and is in communication with the second lumen 104, so that the medium fluid can enter the inside of the balloon 1022 through the flow-through tube. At the same time, the number of balloons 1022 can be one or more. When the medium is injected into the balloon through the second lumen and the flow-through tube, the balloon can be inflated and block the bleeding hole; when the medium is extracted from the balloon through the second lumen and the flow-through tube, the balloon is retracted. Because the balloon is a compliant material, the volume after contraction is very small, and because the flow-through tube itself is a material with a certain supporting effect, it is formed at a position slightly away from the bleeding hole, which can take the retracted balloon away from the bleeding hole, and then open the bleeding hole to let the blood flow out of the bleeding hole. This design can guide the blood to flow out in a more uniform flow field, reduce turbulence, and ensure a larger auxiliary flow, which can increase the arterial perfusion of the patient and effectively relieve the heart load.
[0042] In this embodiment, a one-way valve 105 is also arranged in the first cavity 103, which is arranged at the distal end of the blood inlet 101 or on the blood inlet 101, to control the blood flow only from the proximal end to the distal end, and not to flow back from the distal end to the blood inlet 101. That is, when the heart contracts, the blood enters from the blood inlet 101 and flows into the blood cavity 2041 of the diaphragm pump 204 through the one-way valve 105 which opens only in the distal direction. When the heart relaxes, the blood is squeezed out of the blood cavity 2041 and flows out from the blood outlet hole 1021, bringing blood supply to the patient. However, in this process, the blood is blocked by the one-way valve 105, so it can only flow out from the blood outlet hole 1021 and not flow back to the blood inlet 101, ensuring the direction of blood flow. On this basis, the one-way valve 105 can be arranged in the first cavity 103 between the blood inlet 101 and the blood outlet 102, or it can be arranged on the blood inlet 101. The one-way valve 105 can be single-piece or multi-piece, as long as it can control the direction of blood flow, which is not limited here.
[0043] The use process of the inflatable catheter includes: the catheter is guided, the front end of the catheter (i.e. the blood inlet 101) enters the left ventricle from the aorta 302 and is positioned therein, and the blood outlet 102 is positioned in the aorta 302, to ensure that the blood is drawn from the left ventricle into the aorta 302 when the heart contracts. When the heart contracts, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is drawn out, causing the diaphragm to move towards the medium cavity, and the corresponding blood cavity 2041 sucks the blood from the blood inlet 101 into the first cavity 103 of the catheter. At this time, the one-way valve 105 is open, the balloon 1022 of the blood outlet 102 is inflated and bulges to block and seal the blood outlet hole 1021. When the heart relaxes, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is inflated, causing the diaphragm to move towards the blood cavity. The corresponding blood cavity 2041 discharges blood, and the balloon 1022 of the blood outlet 102 shrinks as the medium in the balloon 1022 is drawn out through the flow pipe and the second cavity, exposing the blood outlet hole 1021. The one-way valve 105 does not allow blood to flow back to the blood inlet 101, so the blood flows out of the blood outlet hole 1021 to the aorta 302, bringing blood supply to the patient.
[0044] In some embodiments, the balloon 1022 is made of a compliant biocompatible polymer material, such as polyurethane, thermoplastic polyurethane elastomer, polyamide, polyamide block copolymer or silicone. The material of the flow pipe is a biocompatible pebax, TPU or a composite material of two or more mixed materials. To optimize the forming support performance of the flow pipe, the Shore hardness is in the range of 40A-60A, so that it can allow the medium to flow while supporting the shrunken balloon principle blood outlet hole, and will not damage the patient's blood vessel due to excessive hardness. The number of balloons can be one or more, but in the inflated state, it can completely cover and block the blood outlet hole.
[0045] In a preferred embodiment, as shown in Figs. 2-4 The multi-lumen tube body 10 is the main structure of the catheter 201, and is internally provided with a first lumen 103 and a second lumen 104 which are isolated from each other. The first lumen 103 is specially used for blood flow, and is provided at the proximal end of the multi-lumen tube body 10 with a blood inlet 101 which is in communication with the blood in the aorta 302 to form a blood inflow passage. The second lumen 104 is completely not in communication with the blood, and is specially used for the flow of a medium which controls the inflation of the balloon 1022 through the second lumen 104 and a flow passage. The medium flowing through the second lumen 104 can be a liquid medium such as normal saline, or a gaseous medium such as helium, air, inert gas, etc. The inner diameter of the multi-lumen tube body 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 body 10. This design not only ensures sufficient space for blood flow, but also provides a proper passage for the flow of the medium.
[0046] The bleeding part 102 is provided at the distal end of the blood inlet 101, and includes two key components, a bleeding hole 1021 and a balloon film 1022. The bleeding hole 1021 is formed in the wall of the multi-lumen tube body 10, and can communicate the first lumen 103 with the blood in the aorta 302. The bleeding holes 1021 are distributed in a row along the circumference of the multi-lumen tube body 10, and the number of the bleeding holes 1021 is at least one, which are uniformly distributed to ensure the stability and uniformity of the blood outflow. Each bleeding hole 1021 is ensured to be covered and blocked by the balloon 1022 which is inflated.
[0047] The balloon 1022 is provided outside the wall of the multi-lumen tube body 10 at the corresponding position of the bleeding hole 1021, and the proximal end side and the distal end side of the balloon are connected with the wall of the multi-lumen tube body through a flow passage with a certain supporting effect, and the connection mode includes but is not limited to heat fusion, adhesion and other fixing modes, and is in communication with the second lumen 104, so that the medium fluid can enter the inside of the balloon 1022 through the flow passage. The distal end of the balloon 1022 also adheres to the outer wall of the multi-lumen tube body 10, at this time the proximal end and / or the distal end of the balloon 1022 is in communication with the second lumen 104, and the unconnected end is connected with the flow passage with a certain supporting effect, so that the medium fluid can enter the inside of the balloon film 1022 to form a complete medium flow circuit, and the number of the balloon 1022 needs to be greater than one at this time. The shape of the balloon 1022 is spherical or ellipsoidal structure. This design can guide the blood to flow out in a more uniform flow field, and reduce the turbulent flow.
[0048] The balloon film 1022 is made of polyurethane, thermoplastic polyurethane elastomer, polyamide, polyamide block copolymer or silicone, and such materials have excellent biocompatibility and elastic properties, and can withstand repeated inflation and contraction without fatigue failure.
[0049] The material of the flow pipe can be a biocompatible polyamide block copolymer (pebax), polyurethane (TPU), or a composite material mixed with two or more materials. The flow pipe has a certain supporting performance, with a Shore hardness ranging from 40A to 60A, so that it can support the shrunken balloon principle bleeding hole while allowing the medium to flow, and will not damage the patient's blood vessels due to excessive hardness.
[0050] In a preferred embodiment, the multi-lumen tube body 10 is the main structure of the catheter 201, and is internally provided with a first lumen 103 and a second lumen 104 isolated from each other. The first lumen 103 is specially used for blood flow, and is provided with a blood inlet 101 at the proximal end of the multi-lumen tube body 10, which is in communication with the blood in the aorta 302 to form a blood inflow channel. The second lumen 104 is completely not in communication with the blood, and is specially used for the flow of the medium, which realizes the inflation control of the balloon 1022 through the second lumen 104. The medium flowing through the second lumen 104 can be liquid medium such as physiological saline, or gas medium such as helium, air, and inert gas. The balloon 1022 is arranged outside the tube wall at the corresponding position of the bleeding hole 1021, and the proximal end side and the distal end side of the balloon are connected together by the flow pipe with a certain supporting effect, and the connection mode includes but is not limited to heat melting, bonding and other fixing modes, and is in communication with the second lumen 104, so that the medium fluid can enter the inside of the balloon 1022 through the flow pipe. In this embodiment, the number of flow pipes can be set to multiple, and multiple flow pipes can control a single balloon 1022, or different balloons 1022 can be independently controlled, aiming to provide more accurate control ability and make the balloon 1022 respond more quickly.
[0051] And the inner diameter of the multi-lumen tube body 10 is 4.5mm, 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 body 10. This design not only ensures sufficient space for blood flow, but also provides a suitable channel for medium flow.
[0052] In another preferred embodiment, the balloon 1022 can also be made of silicone or thermoplastic polyurethane elastomer, which also has good biocompatibility and mechanical properties.
[0053] The working principle of the inflatable catheter is as follows: when the medium is injected into the balloon through the second cavity and the flow-through tube, the balloon can be inflated and bulged to block and seal the bleeding hole; when the medium is extracted from the balloon through the second cavity and the flow-through tube, the balloon is deflated, and because the flow-through tube is formed by a material with a certain supporting effect at a position slightly away from the bleeding hole, the deflated balloon can be taken away from the bleeding hole, thereby opening the bleeding hole and allowing blood to flow out of the bleeding hole to provide blood supply for the patient. This design can guide the blood to flow out in a more uniform flow field, reduce turbulence, and ensure a large auxiliary flow, which can increase arterial perfusion for the patient and effectively relieve the heart load.
[0054] By precisely controlling the inflation and extraction timing of the medium, the catheter 201 can be synchronized with the heart rhythm of the patient. When the heart contracts, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is extracted, causing the diaphragm to displace towards the medium cavity. The corresponding blood cavity 2041 sucks blood from the blood inlet 101 into the first cavity 103 of the catheter. At this time, the one-way valve 105 is opened, and the balloon 1022 of the bleeding part 102 is inflated and bulged to block and seal the bleeding hole 1021. When the heart relaxes, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is inflated, causing the diaphragm to displace towards the blood cavity. The corresponding blood cavity 2041 discharges blood, and the balloon 1022 of the bleeding part 102 shrinks due to the extraction of the medium through the flow-through tube and the second cavity, exposing the bleeding hole 1021. The one-way valve 105 does not allow blood to flow back to the blood inlet 101, and blood flows out of the bleeding hole 1021 to the aorta 302, providing blood supply for the patient. This design effectively solves the problem of inaccurate blood flow control in traditional catheters, improving the efficiency and safety of blood auxiliary supply.
[0055] The working principle of the device is as follows: the extracorporeal host controls the inflation and extraction of the medium in the second cavity 104 according to the rhythm of the patient's pulse. When the medium is inflated, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is inflated, causing the diaphragm to displace towards the blood cavity 2041. The corresponding blood cavity 2041 discharges blood, and the balloon 1022 of the bleeding part 102 shrinks due to the extraction of the medium through the flow-through tube and the second cavity, exposing the bleeding hole 1021. Blood flows out of the bleeding hole 1021 into the descending aorta 302, providing blood supply for the patient; when the medium is extracted, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is extracted, causing the diaphragm to displace towards the medium cavity. The corresponding blood cavity 2041 sucks blood from the blood inlet 101 into the first cavity 103 of the catheter. At this time, the one-way valve 105 is opened, and the balloon 1022 of the bleeding part 102 is inflated and bulged to block and seal the bleeding hole 1021.
[0056] The flow tube with support makes the balloon have a suitable space to expand, and the uniform transmission of medium pressure avoids the problems of local over-expansion or insufficient contraction of the balloon. At the same time, when the balloon is contracted and the bleeding hole is exposed, a suitable outflow space is provided to optimize the hemodynamic characteristics of blood flow, reduce blood flow resistance, and improve blood transport efficiency. The structure design enables the entire device to provide stable and reliable blood circulation assistance function in the application of ventricular assistance.
[0057] Embodiments of the present application also provide a ventricular assistance device, as shown in the drawings, which comprises an inflatable catheter, a diaphragm pump 204 and a control host 205. Fig. 5
[0058] The inflatable catheter adopts the structure described in any of the above embodiments, including the cavity tube body 10, the blood inlet 101, the bleeding part 102, the first cavity 103, the second cavity 104 and other key components. The multi-cavity tube body 10 is the main structure of the catheter 201, and the first cavity 103 and the second cavity 104 are isolated inside. The first cavity 103 is specially used for blood flow, and the blood inlet 101 is provided at the proximal end of the multi-cavity tube body 10, which is in communication with the blood in the aorta 302 to form a blood inflow channel. The second cavity 104 is completely not in communication with the blood, and is specially used for the flow of the medium, which realizes the inflation control of the balloon 1022 through the second cavity 104. The bleeding part 102 is provided at the distal end of the blood inlet 101, and includes three key components, i.e. the bleeding hole 1021, the balloon 1022 and the flow tube 1023. The bleeding hole 1021 is opened on the wall of the multi-cavity tube body 10, and can communicate the first cavity 103 with the blood in the aorta 302. The bleeding holes 1021 are distributed in a row along the circumference of the multi-cavity tube body 10, and the number of the bleeding holes 1021 is at least one, which are uniformly distributed to ensure the stability and uniformity of blood outflow. Each bleeding hole 1021 is guaranteed to be covered by the inflated balloon 1022.
[0059] The diaphragm pump 204 is the power component of the ventricular assistance device 20, which includes a pump shell and a diaphragm 2043 in the pump shell. The pump shell has a cavity which is divided into two independent working areas, i.e. a blood cavity 2041 and a medium cavity 2042 by the diaphragm 2043. The blood cavity 2041 is connected with the first cavity 103 of the aortic catheter to form a blood circulation loop, which can realize the functions of blood suction and pumping. The medium cavity 2042 serves as the driving cavity of the diaphragm pump 204, which drives the diaphragm 2043 to move through the change of medium pressure, so as to realize the compression and expansion of the blood cavity 2041. The diaphragm 2043 is made of flexible material, which has good elasticity and fatigue resistance, and can withstand long-term reciprocating motion without damage, ensuring the long-term stable operation of the device.
[0060] The control host 205 is the control center of the whole ventricular assist device 20, which has a dual connection function. The control host 205 is connected with the medium cavity 2042 of the diaphragm pump 204, drives the diaphragm 2043 to move by injecting or extracting the medium into the medium cavity 2042, and then controls the diaphragm pump 204 to suck or pump blood. At the same time, the control host 205 is directly or indirectly connected with the second cavity 104 of the intra-aortic catheter, which is used to drive the expansion or contraction of the balloon 1022. The control host 205 is built-in with a precise pressure control system and a timing control system, which can accurately control the flow of the medium fluid according to the heart rhythm and blood flow demand of the patient, ensure that the operation of the device is highly synchronized with the physiological state of the patient, and can be adjusted according to the actual situation of different patients.
[0061] The working principle of the ventricular assist device 20 involved in the present application is based on the coordinated control of the medium cavity 2042 and the balloon 1022. When the heart contracts, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is extracted, so that the diaphragm is displaced to the medium cavity, and the corresponding blood cavity 2041 sucks blood from the blood inlet 101 into the first cavity 103 of the catheter, at this time the one-way valve 105 is opened, the balloon 1022 of the bleeding part 102 is filled and swollen, and the bleeding hole 1021 is sealed; when the heart relaxes, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is filled, so that the diaphragm is displaced to the blood cavity, the blood is discharged from the blood cavity 2041, and the balloon 1022 of the bleeding part 102 is shrunk due to the extraction of the medium in the balloon 1022 through the flow pipe and the second cavity, the bleeding hole 1021 is exposed, and the one-way valve 105 does not allow the blood to flow back to the blood inlet 101, so the blood flows out of the bleeding hole 1021 to the aorta 302, thereby supplying blood to the patient. This design effectively solves the problem of inaccurate blood flow control in traditional catheters, and improves the efficiency and safety of blood assist supply.
[0062] The control host 205 synchronizes the emptying and filling actions of the medium cavity 2042 with the heart rhythm of the patient through precise timing control. When the heart contracts, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is extracted, so that the diaphragm is displaced to the medium cavity, and the corresponding blood cavity 2041 sucks blood from the blood inlet 101 into the first cavity 103 of the catheter, at this time the one-way valve 105 is opened, the balloon 1022 of the bleeding part 102 is filled and swollen, and the bleeding hole 1021 is sealed; when the heart relaxes, the medium cavity 2042 of the extracorporeal diaphragm pump 204 is filled, so that the diaphragm is displaced to the blood cavity, the blood is discharged from the blood cavity 2041, and the balloon 1022 of the bleeding part 102 is shrunk due to the extraction of the medium in the balloon 1022 through the flow pipe and the second cavity, the bleeding hole 1021 is exposed, and the one-way valve 105 does not allow the blood to flow back to the blood inlet 101, so the blood flows out of the bleeding hole 1021 to the aorta 302, thereby supplying blood to the patient.
[0063] The whole ventricular assist device 20 realizes the accurate control of blood flow and the auxiliary circulation function through the coordination of the diaphragm pump 204, the control host 205 and the inflatable catheter 201, and provides effective mechanical circulation support for the patient with heart dysfunction.
[0064] The above merely describes the preferred embodiments of the present application, and is not intended to limit the present application. Although the present application has been described in detail with reference to the foregoing embodiments, modifications or equivalent replacements of the technical solutions described in the foregoing embodiments can be made by those skilled in the art, or some technical features can be replaced equivalently. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Claims
1. An inflatable 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, and the bleeding section includes a bleeding hole and a balloon; 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 balloon is positioned on the outer side of the tube wall at the corresponding location of the bleeding hole. Both the proximal and distal ends of the balloon are connected to the tube wall of the multi-lumen tube body through a flow tube with a certain supporting function, and are also connected to the second cavity. The inflation and deflation of the medium inside the balloon can be controlled through the flow tube. 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 balloon is in the first state, the filling medium inside the balloon bulges up and blocks and seals the bleeding hole; When the balloon is in the second state, the balloon is not filled with medium. Under the support of the flow tube, it moves away from and opens the bleeding hole, allowing blood to flow out into the blood vessel through the bleeding hole.
2. The inflatable catheter as described in claim 1, characterized in that, The number of the second cavity is one or more.
3. The inflatable 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 inflatable catheter as described in claim 1, characterized in that, The number of balloons may be one or more, but in the first state, they can completely cover and block the bleeding hole.
5. The inflatable catheter as described in claim 1, characterized in that, The one-way valve can be a single-piece valve or a multi-piece valve, controlling blood flow only from the proximal end to the distal end.
6. The inflatable catheter as described in claim 1, characterized in that, The flow tube provides support, ensuring that the balloon is in the second state away from the bleeding hole. Therefore, the Shore A hardness of the flow tube is in the range of 60A-80A.
7. The inflatable catheter as described in claim 1, characterized in that, The material of the flow tube can be a polyamide block copolymer (pebax), polyurethane (TPU), or a composite material of two or more of these materials that have good biocompatibility.
8. The inflatable catheter as described in claim 1, characterized in that, The balloon is made of a biocompatible polymer material selected from polyurethane, thermoplastic polyurethane elastomer, polyamide, polyamide block copolymer or silicone.
9. The inflatable catheter as described in claim 1, characterized in that, The inner diameter of the multi-cavity tube is in the range of 3mm-5mm; the total cross-sectional area of the second cavity accounts for 2%-10% of the total cross-sectional area of the multi-cavity tube.
10. A ventricular assist device, characterized in that, include: The inflatable 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 balloon to inflate or contract. However, the inflation or deflation of the medium cavity is opposite to the inflation or deflation of the balloon. When the medium cavity is emptied, the balloon is in an inflated state. When the medium cavity is filled, the balloon is in a evacuated state.