Clamping assembly, catheter pump and ventricular assist device
By using elastic extensions and ring-shaped components in the clamping assembly of the ventricular assist device, the problems of gaps and steps at the tubing connection are solved, achieving smooth and safe blood flow and reducing the risk of thrombosis.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SUZHOU HENGRUI HONGYUAN MEDICAL TECH CO LTD
- Filing Date
- 2023-10-20
- Publication Date
- 2026-06-26
AI Technical Summary
In existing ventricular assist devices, gaps, steps, or curled edges exist at the tubing connections, leading to the risk of blood pooling and thrombosis. Existing connection methods are not tight or smooth enough.
The clamping assembly, including a flexible extension and annular component, uses clamping force to tightly fit the inner and outer surfaces of the first and second tubes, forming a smooth transition and avoiding gaps and dimensional changes.
This achieved a tight fit at the connection point of the ventricular assist device tubing, reducing the risk of thrombosis and ensuring smooth blood flow.
Smart Images

Figure CN117599325B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical devices, and more particularly to the field of ventricular assist devices. Background Technology
[0002] Heart failure, or heart disease, is a type of heart disorder. The human heart acts like a pump, continuously delivering blood, nutrients, and oxygen to the entire body at a rate of 5-6 liters per minute, while also removing metabolic waste. When any structure or function of the heart becomes abnormal due to various reasons, its ability to "return blood" or "pump blood" to the body is impaired. This leads to a series of complex clinical syndromes, which constitute heart failure.
[0003] Heart transplantation remains the most effective treatment for end-stage heart failure, but the shortage of donors is becoming increasingly severe. In recent years, rapidly developing mechanical circulatory support technologies have provided a variety of treatment options for patients with end-stage heart failure. Ventricular assist devices (VADs), as an important form of mechanical circulatory support, have demonstrated significant value in bridging heart transplantation, endpoint treatment, and buying time for clinical decision-making.
[0004] In the field of ventricular assist devices, the connections between the components of a catheter pump are generally made by welding or other methods after the components come into contact and abut each other. Nesting can also be used, with direct nesting being the preferred method. Usually, the diameter or other nesting parameters between the components are not considered. However, these two conventional methods may result in gaps, steps, or rolled edges at the joint. For example, if the contact surfaces of two components are directly abutted and then welded, such a structure may produce weld protrusions at the contact points, resulting in an uneven surface, or a risk of detachment after welding. Another example is a directly nested design where the different diameters of the components or the thickness of each structure create steps at the joint. Specifically, when the insert tube is nested into the composite sleeve, the thickness of the insert tube itself creates a transition step or rolled edge between the insert tube and the composite sleeve. These structures can cause blood to accumulate when blood flows through these areas, potentially leading to thrombosis over time. Therefore, a different nesting method is needed, where there is a clamping force between the components. This clamping force tightly clamps the components together, forming a specific assembly relationship. Components with a tight clamping relationship smoothly transition without gaps or dimensional changes. The connection of multiple components forms a complete and smooth surface, allowing for smooth blood flow and reducing the risk of thrombosis. Summary of the Invention
[0005] This invention provides a clamping assembly for connecting tubing in a ventricular assist device. The clamping assembly ensures that, after assembly, the inner surfaces of the first and second tubes are flush and their connection points are tightly fitted, as are their outer surfaces. This invention also provides a catheter pump and a ventricular assist device. The components of the catheter pump and the ventricular assist device are tightly clamped together by a clamping force. This clamping force ensures that the components are tightly clamped and form a specific assembly relationship. The components with this tight clamping relationship transition smoothly without gaps or dimensional changes. The connection of multiple components forms a complete and smooth surface, ensuring smooth blood flow and reducing the risk of thrombosis.
[0006] To solve the above-mentioned technical problems, one technical solution adopted by the present invention is: a clamping assembly for connecting the tubing of a ventricular assist device, the tubing including a first tube and a second tube, the first tube and the second tube being connected by the clamping assembly, the clamping assembly including an elastic extension and an elastic annular member; the extension is fixed to one end of the second tube and in its natural state the outer diameter of the extension is the same as the outer diameter of the second tube;
[0007] When the first tube and the second tube are connected by the clamping assembly, at least a portion of the first tube is housed inside the annular member, which has an inward clamping force that fixes the first tube to the annular member; an extension fixed to one end of the second tube is clamped in at least a portion of the area outside the annular member, which has an inward clamping force that fixes the extension to the annular member.
[0008] After the annular part is assembled with the first tube and the extension part is assembled with the annular part, the outer surfaces of the annular part, the extension part, the first tube and the second tube are on the same surface and the connection is tightly fitted. The inner surfaces of the annular part, the first tube and the second tube are on the same surface and the connection is tightly fitted.
[0009] As one embodiment, the clamping assembly further includes a positioning element and a receiving element. The positioning element is disposed at one end of the inner surface of the annular element and is clamped inward by the clamping force of the annular element. One end of the positioning element abuts against the first tube, and the other end of the positioning element abuts against the second tube. The inner surface of the positioning element is on the same surface as the inner surfaces of the first tube and the second tube, and the connection is tightly fitted so that the connection between the first tube, the positioning element, and the second tube forms a complete and smooth inner surface without gaps or dimensional changes.
[0010] The receiving component is fixed to the outer surface of the ring component and to the opposite end of the positioning component. One end of the receiving component abuts against the first tube, and the other end abuts against the extension component. After the receiving component and the extension component are assembled, the outer surfaces of the receiving component and the extension component are on the same surface as the outer surfaces of the first tube and the second tube, and the connection is tightly fitted, so that the connection between the first tube, the receiving component, the extension component, and the second tube forms a complete and smooth outer surface without gaps or dimensional changes.
[0011] As one embodiment, the second tube is configured as a tube structure with no less than two layers. The second tube includes an outer tube and an inner tube. An extension is fixed to one end of the outer tube and the extension has the same outer diameter as the outer tube. The inner tube abuts against one end of the positioning member and the inner diameter of the inner tube has the same inner diameter as the positioning member.
[0012] This application also includes a second technical solution: a catheter pump for ventricular assist therapy, comprising: an inlet tube, a composite cannula, and a motor assembly. Blood flows into the catheter pump through the inlet tube, passes through the composite cannula, and exits from the motor assembly. The motor assembly is configured to provide driving force for the blood flow. The catheter pump also includes a clamping assembly, which includes an elastic extension and an elastic annular member. The extension is fixed to both ends of the composite cannula. At least a portion of the inlet tube and the motor assembly are tightly clamped inside the annular member, and at least a portion of the annular member is tightly clamped inside the extension. This ensures that the inner surfaces of the inlet tube, the composite cannula, and the motor assembly are on the same surface and that the connections are tightly fitted. It also ensures that the outer surfaces of the inlet tube, the composite cannula, and the motor assembly are on the same surface and that the connections are tightly fitted. This results in the inlet tube, the composite cannula, and the motor assembly forming a complete, smooth inner and outer surface without gaps or dimensional variations.
[0013] As one embodiment, the clamping assembly further includes a positioning member and a receiving member. At least a portion of the positioning member is tightly clamped inside the annular member and is used for smoothly connecting the inlet tube and the inner tube of the composite sleeve, as well as the inner tube of the composite sleeve and the motor assembly. At least a portion of the receiving member is disposed outside the annular member and is used for smoothly connecting the inlet tube and the extension member, as well as the extension member and the motor assembly.
[0014] As one embodiment, the annular component is configured as a hollow annular structure, comprising a first annular component and a second annular component. At least a portion of the inlet tube is tightly clamped inside the first annular component, at least a portion of the motor assembly is tightly clamped inside the second annular component, and at least a portion of the first and second annular components is tightly clamped inside the extension component.
[0015] As one embodiment, the positioning element includes a first positioning element and a second positioning element. The first positioning element is configured to be housed inside the first annular element and cooperates with the inner tube of the inlet tube and the composite sleeve to ensure that the inner surfaces of the inlet tube, the first positioning element, and the composite sleeve are located on the same surface and that the connection is tightly fitted. The second positioning element is configured to be housed inside the second annular element and cooperates with the inner tube of the motor assembly and the composite sleeve to ensure that the inner surfaces of the motor assembly, the second positioning element, and the composite sleeve are located on the same surface and that the connection is tightly fitted, thereby making the inlet tube, the composite sleeve, and the motor assembly form a complete and smooth inner surface without gaps or dimensional changes.
[0016] As one embodiment, the receiving component includes a first receiving component and a second receiving component. The first receiving component is configured to be fixed to the outside of the first annular component and cooperates with the inlet tube and the extension component to ensure that the outer surfaces of the inlet tube, the first receiving component, and the composite sleeve are located on the same surface and the connection is tightly fitted. The second receiving component is configured to be fixed to the outside of the second annular component and cooperates with the motor assembly and the extension component to ensure that the outer surfaces of the motor assembly, the second receiving component, and the composite sleeve are located on the same surface and the connection is tightly fitted, thereby making the inlet tube, the composite sleeve, and the motor assembly form a complete and smooth outer surface without gaps or dimensional changes.
[0017] As one embodiment, the distal end face of the first positioning member abuts against the proximal end face of the inlet tube, the proximal end face of the first positioning member abuts against the distal end face of the inner tube, the thickness of the portion of the inlet tube extending into the first annular member is the same as the thickness of the first positioning member, the inner surfaces of the inlet tube, the first positioning member, and the inner tube are located on the same surface, and the connection is tightly fitted to form a smooth connection and an inner surface without dimensional changes.
[0018] The proximal end face of the second positioning member abuts against the distal end face of the motor assembly, and the distal end face of the second positioning member abuts against the proximal end face of the inner tube. The thickness of the portion of the motor assembly extending into the second annular member is the same as the thickness of the second positioning member. The inner surfaces of the inner tube, the second positioning member, and the motor assembly are located on the same surface, and the connection is tightly fitted to form a smooth connection and an inner surface without dimensional changes.
[0019] As one embodiment, the extension is housed between the proximal end face of the first receiving member and the distal end face of the second receiving member. The thickness of the extension in the direction perpendicular to the extension of the tube is the same as the thickness of the first receiving member and the second receiving member to ensure that the outer surfaces of the first receiving member, the extension, and the second receiving member are located on the same surface and that the connection is tightly fitted, so that the first receiving member, the extension, and the second receiving member form a smooth connection with no dimensional change in the outer surface.
[0020] As one embodiment, the inlet tube is provided with a first end face, and the motor assembly is provided with a second end face. The first end face abuts against the far end face of the first receiving member. The thickness of the first end face along the extension direction perpendicular to the inlet tube is the same as the sum of the thicknesses of the first receiving member and the first annular member, so that the outer surfaces of the inlet tube, the first receiving member, the extension member, and the outer tube are located on the same surface, and the connection is tightly fitted to form a smooth connection and an outer surface without dimensional changes.
[0021] The second end face abuts against the near end face of the second receiving member. The thickness of the second end face along the extension direction perpendicular to the motor assembly is the same as the sum of the thicknesses of the second receiving member and the second annular member, so that the outer surfaces of the motor assembly, the second receiving member, the extension member, and the outer tube are flush, forming a smooth connection and an outer surface without dimensional changes.
[0022] As one embodiment, the inlet tube is provided with a first snap-fit surface, and the motor assembly is provided with a second snap-fit surface. The first snap-fit surface is tightly clamped in the inner hole of the first annular member, and the second snap-fit surface is tightly clamped in the inner hole of the second annular member, so that the distal end surface of the first receiving member abuts against the proximal end surface of the inlet tube, and the proximal end surface of the second receiving member abuts against the distal end surface of the motor assembly.
[0023] As one embodiment, the composite sleeve also includes a reinforcing tube, which is used to increase the strength of the composite sleeve and provide support for the outer tube; the outer tube is disposed outside the reinforcing tube to protect the reinforcing tube and the inner tube and to increase the lubricity of the composite sleeve.
[0024] As one embodiment, the intubation tube also includes a guide end and an inlet. The guide end includes a tip located at the distal end and a ball end protruding towards the inlet side. The tip is used to reduce the resistance of the catheter pump when entering the human body, and the ball end is used to guide blood into the inlet.
[0025] As one embodiment, the motor assembly includes an impeller, a pump housing, and a motor. The impeller is housed within the pump housing. The rotation of the motor drives the impeller to rotate circumferentially, thereby driving blood from the inlet pipe into the duct pump. The pump housing is used to rectify the blood flowing through the impeller and prevent the blood from spreading circumferentially due to the rotational force.
[0026] As one embodiment, a first slot is provided on the outer surface of the motor, and an extension slot is provided on the outer surface of the pump housing. The first slot and the extension slot are used to accommodate a pressure sensor, which is used to monitor blood pressure.
[0027] As one embodiment, the motor assembly also includes a tail cover with a second slot for a pressure sensor to extend into the first slot and the extension slot.
[0028] As one embodiment, the impeller includes a hub and blades arranged around the hub axis. The hub is configured as a conical structure, including a guide head end and a hub body. The guide head end is used to guide blood, and the hub body extends towards the motor side and the diameter of the hub body gradually increases.
[0029] The motor has a curved surface, and the inclination of the motor surface relative to the motor axis is the same as the inclination of the curved surface of the hub body relative to the hub body axis.
[0030] This application also includes a third technical solution, a ventricular assist device, which includes a catheter pump of any of the above technical solutions.
[0031] As one embodiment, it also includes a delivery conduit that is signal-connected to a conduit pump. The delivery conduit includes an inner liner, a support layer, and an outer sheath. The inner liner has a receiving cavity for receiving wires signal-connected to the conduit pump. The support layer is used to improve the support of the delivery conduit. The outer sheath is used to protect the support layer.
[0032] As one embodiment, it also includes a controller and a flushing system. The controller is signal-connected to the duct pump and the flushing system and is used to adjust the operating parameters of the duct pump and the flushing system. The flushing system is fluidly connected to the duct pump and is used to flush the duct pump during operation.
[0033] As one embodiment, the flushing system includes a flushing fluid line, an accumulator, and an air filter. The accumulator and the air filter are fixed to the flushing fluid line. The accumulator is used to provide flushing pressure to the flushing fluid, and the air filter is used to filter out air and prevent air from entering the conduit pump.
[0034] As one embodiment, the flushing system also includes a flushing fluid bag, a puncture device, and a drive box. The puncture device is inserted into the flushing fluid bag and fixedly connected to the flushing fluid line so that the drive box drives the flushing fluid to flow from the flushing fluid bag into the flushing fluid line.
[0035] The beneficial effects of the present invention are as follows: Unlike the prior art, the clamping assembly provided by the present invention is used for connecting the tubing of a ventricular assist device. The clamping assembly includes an extension member and an elastic member. The tubing includes a first tube and a second tube. When the first tube and the second tube are connected by the clamping assembly, the inward clamping force of the annular member fixes the first tube to the annular member, and the inward clamping force of the extension member fixes the extension member to the annular member. This ensures that the outer surfaces of the annular member, the extension member, the first tube, and the second tube are on the same surface and the connection is tightly fitted. The inner surfaces of the annular member, the first tube, and the second tube are on the same surface and the connection is tightly fitted.
[0036] The catheter pump provided by this invention is used in a ventricular assist device. The catheter pump includes a clamping assembly, which includes an elastic extension and an annular component. The annular component is elastic and can clamp the inlet tube and motor assembly therein, and exert a large clamping force on the inlet tube and motor assembly. The extension is elastic and can clamp the annular component therein, and exert a large clamping force on the annular component. The tight clamping relationship between the extension and the annular component, as well as the tight clamping relationship between the annular component and the inlet tube and motor assembly, enables the catheter pump to form a specific assembly relationship. The components with tight clamping relationships have a smooth transition without gaps or dimensional changes. The connection of multiple components enables the catheter pump to form a complete and smooth inner and outer surface. The smooth surface allows for smooth blood flow and reduces the risk of thrombus accumulation. Attached Figure Description
[0037] Figure 1 This is a schematic diagram of a ventricular assist device.
[0038] Figure 2 This is a schematic diagram of a duct pump.
[0039] Figure 3 This is a schematic diagram of the inner tube, reinforcing tube, and outer tube structure of the composite sleeve;
[0040] Figure 4 This is a schematic diagram showing the connection between the outer tube and the extension of the composite sleeve.
[0041] Figure 5 A schematic diagram of the assembly of the first annular component, the second annular component, the extension component, and the composite sleeve;
[0042] Figure 6 This is a schematic diagram of the ring-shaped component structure;
[0043] Figure 7 This is a cross-sectional structural diagram of the first and second annular components;
[0044] Figure 8 for Figure 7 Enlarged view of point A in the middle;
[0045] Figure 9 for Figure 7 Enlarged view at point B in the middle;
[0046] Figure 10 A schematic diagram of the assembly of the inlet tube, the first annular component, and the extension component;
[0047] Figure 11 for Figure 10 Enlarged view of a specific area;
[0048] Figure 12 A schematic diagram of the assembly of the extension component, the second ring component, and the motor assembly;
[0049] Figure 13 This is a schematic diagram of the inlet pipe structure;
[0050] Figure 14 This is a schematic diagram of the motor assembly structure;
[0051] Figure 15 This is an enlarged view of the pump casing structure of the motor assembly;
[0052] Figure 16 This is a schematic diagram of the tail cap structure;
[0053] Figure 17 This is a schematic diagram of the impeller structure;
[0054] Figure 18 This is a schematic diagram of the delivery conduit structure;
[0055] Figure 19 This is a schematic diagram of the flushing system. Detailed Implementation
[0056] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.
[0057] The terms "first" and "second" used in this application are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.
[0058] In this embodiment, the proximal end is the end closer to the operator, and the distal end is the end farther away from the operator.
[0059] In the field of ventricular assist devices, the clamping assembly is used to connect the two sections of tubing, namely the first tube and the second tube, of the ventricular assist device through an extension 105 and an annular member 104. By introducing the structure of the extension 105 and the annular member 104, the outer surfaces of the annular member 104 and the extension 105 are on the same surface as the outer surfaces of the first tube and the second tube, and the connection is tightly fitted. The inner surface of the annular member 104 is on the same surface as the inner surfaces of the first tube and the second tube, and the connection is tightly fitted. A smooth and complete surface is formed at the assembly connection position of the first tube, the annular member 104, the extension 105, and the second tube, so that blood flows smoothly and smoothly through the connection of the first tube and the second tube, without blood accumulation, reducing the risk of thrombosis.
[0060] This application provides a clamping assembly for connecting tubing between ventricular assist devices. The tubing includes a first tube and a second tube, both having the same inner and outer diameters. The first and second tubes are connected by the clamping assembly, which includes an elastic extension 105 and an elastic annular member 104. Both the extension 105 and the annular member 104 are hollow tubular structures, and their elastic structure provides a strong inward clamping force. The extension 105 is fixed to one end of the second tube, and in its natural state, the extension 105 has the same outer diameter as the second tube. Specifically, the inner diameter of the annular member 104 is larger than at least a portion of the outer diameter of the first tube. When at least a portion of the first tube is housed within the annular member 104, the inward clamping force of the annular member 104 firmly clamps at least a portion of the first tube, achieving a fixed connection between the first tube and the annular member 104. Similarly, the inner diameter of the extension 105 is larger than the outer diameter of at least a portion of the annular member 104. When at least a portion of the annular member 104 is located inside the extension 105, the inward clamping force of the extension 105 will firmly clamp at least a portion of the annular member 104, thus achieving a fixed connection between the annular member 104 and the extension 105. The annular member 104 is tightly clamped in at least a portion of the first tube, and the extension 105 is tightly clamped in at least a portion of the annular member 104. The extension 105 is also located at one end of the second tube, and the diameter of the extension 105 is the same as the outer diameter of the second tube. Therefore, the arrangement of the annular member 104 and the extension 105 achieves a smooth transition between the first tube and the second tube. The outer surfaces of the annular member 104 and the extension 105 are on the same surface as the outer surfaces of the first tube and the second tube, and the connection is tightly fitted. The inner surface of the annular member 104 is on the same surface as the inner surfaces of the first tube and the second tube, and the connection is tightly fitted. This results in the assembly connection of the first tube, the annular part 104, the extension part 105, and the second tube forming a complete and smooth inner and outer surface without gaps or dimensional changes.
[0061] In one embodiment, the clamping assembly further includes a positioning element and a receiving element. The positioning element is disposed at one end of the inner surface of the annular element 104 and is clamped inward by the clamping force of the annular element 104. One end of the positioning element abuts against the first tube, and the other end of the positioning element abuts against the second tube. The inner surface of the positioning element is on the same surface as the inner surfaces of the first tube and the second tube, and the connection is tightly fitted so that the connection between the first tube, the positioning element, and the second tube forms a complete and smooth inner surface without gaps or dimensional changes.
[0062] Specifically, the second tube is configured as a tube structure with no less than two layers, including an inner tube and an outer tube. The extension 105 is fixed to one end of the outer tube 1022, and the outer diameter of the extension 105 is the same as the outer diameter of the outer tube 1022. In this embodiment, one end of the positioning member abuts against the first tube, and the other end of the positioning member abuts against the inner tube. The inner surface of the positioning member is on the same surface as the inner surfaces of the first tube and the second tube, and the connection is tightly fitted, so that the connection between the first tube, the positioning member, and the second tube forms a complete and smooth inner surface without gaps or dimensional changes.
[0063] In one embodiment, the receiving member is fixed to the outer surface of the annular member 104 at the end opposite to the positioning member. One end of the receiving member abuts against the first tube, and the other end abuts against the extension member 105. Since the outer diameter of the extension member 105 is the same as the outer diameter of the outer tube, the outer surfaces of the receiving member and the extension member 105 are located on the same surface as the outer surfaces of the first tube and the outer tube 1022, and the connection is tightly fitted, so that the connection of the first tube, the receiving member, the extension member 105, and the outer tube 1022 forms a complete and smooth outer surface without gaps or dimensional changes.
[0064] In one embodiment, the first tube can be either the inlet tube or the motor assembly, and the second tube can be a composite sleeve.
[0065] This application also provides a catheter pump 100 for ventricular assist therapy, see [link to relevant documentation]. Figure 2 The catheter pump 100 includes an inlet tube 101, a composite sleeve 102, and a motor assembly 103. Blood flows into the inlet tube 101, passes through the composite sleeve 102, and exits from the motor assembly 103. The motor assembly 103 is configured to provide driving force for the blood flow. The catheter pump 100 also includes a clamping assembly comprising a resilient extension 105 and a resilient annular member 104. (See [link to relevant documentation]). Figure 4-5 The extension 105 is fixed to both ends of the composite sleeve 102. The inlet tube 101 and at least a portion of the motor assembly 103 are tightly clamped inside the annular member 104, and at least a portion of the annular member 104 is tightly clamped inside the extension 105, ensuring that the inner surfaces of the inlet tube 101, the composite sleeve, and the motor assembly 103 are flush, and ensuring that the surfaces of the inlet tube 101, the composite sleeve, and the motor assembly 103 are flush, thereby forming a complete and smooth inner and outer surface without gaps or dimensional changes.
[0066] Specifically, the inlet tube 101, the composite cannula 102, and the motor assembly 103 are sequentially arranged in the ventricular assist device from distal to proximal, with the distal end being the end furthest from the operator and the proximal end being the end closest to the operator. The inlet tube 101 is nested with the composite cannula 102 via an annular member 104, and the composite cannula 102 is nested with the motor assembly 103 via an annular member 104. The inlet tube 101 is positioned in the left ventricle, the distal portion of the composite cannula 102 is positioned in the left ventricle, the proximal portion of the composite cannula 102 is positioned in the aorta, and the motor assembly 103 is positioned within the aorta. Blood enters the catheter pump 100 through the inlet tube 101, flows through the composite cannula 102, and exits the catheter pump 100 from the motor assembly 103. The composite cannula 102 provides a pathway for blood flow. The catheter pump 100 uses the composite cannula 102 to deliver blood from the left ventricle to the aorta, assisting heart failure patients in pumping blood from the left ventricle. In one embodiment, the composite cannula is configured as a composite structure with no less than two layers, and an inner tube 1021 and an outer tube 1022 are arranged sequentially from the inside to the outside. The axial lengths of the inner tube 1021 and the outer tube 1022 are the same. An extension 105 is fixed to both ends of the outer tube 1022, and the outer diameter of the extension 105 is the same as that of the outer tube 1022.
[0067] Please see Figures 6-14The annular component includes a first annular component 1041 and a second annular component 1042. The first annular component 1041 and the second annular component 1042 have identical structures and equal dimensions. The first annular component 1041 and the second annular component 1042 are configured as elastic hollow annular structures with strong clamping force. Specifically, the inner diameter of the first annular component 1041 is larger than the outer diameter of at least a portion of the inlet tube 101. When at least a portion of the inlet tube 101 is housed within the first annular component 1041, the inward clamping force of the first annular component 1041 firmly clamps at least a portion of the inlet tube 101, achieving a fixed connection between the inlet tube 101 and the first annular component 1041, resulting in a seamless fit between the first annular component 1041 and the inlet tube 101. The second annular member 1042 has an inner diameter larger than the outer diameter of at least a portion of the motor assembly 103. When at least a portion of the motor assembly 103 is housed inside the second annular member 1042, the inward clamping force of the second annular member 1042 will firmly clamp at least a portion of the motor assembly 103, thus achieving a fixed connection between the motor assembly 103 and the second annular member 1042. This ensures that the second annular member 1042 and the motor assembly 103 are tightly fitted without any gaps, preventing blood from accumulating when a thrombus flows through this area. Furthermore, the inner diameter of the extension 105 is larger than the inner diameter of at least a portion of the first annular member 1041 and the second annular member 1042. When at least a portion of the first annular member 1041 and the second annular member 1042 are located inside the extension 105, the inward clamping force of the extension 105 will firmly clamp at least a portion of the first annular member 1041 and the second annular member 1042, thereby achieving a fixed connection between the first annular member 1041, the second annular member 1042 and the extension 105. This ensures that the first annular member 1041, the second annular member 1042 and the extension 105 are tightly fitted without any gaps, preventing blood from accumulating when thrombi flow through this area.
[0068] It should be noted that the assembly of the first annular member 1041 with the inlet tube 101, the assembly of the second annular member 1042 with the motor assembly 103, and the assembly of the extension member 105 with the first annular member 1041 and the second annular member 1042 are all interference fits. That is, the first annular member 1041 has a large clamping force on the inlet tube 101, so that the first annular member 1041 and the inlet tube 101 fit tightly and without gaps; the second annular member 1042 has a large clamping force on the motor assembly 103, so that the second annular member 1042 and the motor assembly 103 fit tightly and without gaps; the extension member 105 has a large clamping force on the first annular member 1041 and the second annular member 1042, so that the extension member 105 fits tightly and without gaps with the first annular member 1041 and the second annular member 1042.
[0069] In one embodiment, the clamping assembly further includes a positioning member and a receiving member. At least a portion of the positioning member is tightly clamped inside the annular member 104 and is used to smoothly connect the inlet tube 101 to the inner tube 1021 of the composite sleeve, and the inner tube 1021 of the composite sleeve to the motor assembly 103. At least a portion of the receiving member is disposed outside the annular member 104 and is used to smoothly connect the inlet tube 101 to the extension member 105, and the extension member 105 to the motor assembly 103.
[0070] In one embodiment, the positioning element includes a first positioning element 10411 and a second positioning element 10421. The first positioning element 10411 and the second positioning element 10421 have the same structure and equal size, and are both hollow tubular structures. Please refer to [link / reference]. Figure 7 The first positioning member 10411 is configured to be housed inside the first annular member 1041 and cooperates with the inner tube 1021 of the inlet tube 101 and the composite sleeve to ensure that the inner surfaces of the inlet tube 101, the first positioning member 10411, and the composite sleeve 102 are on the same surface and the connection is tightly fitted; the second positioning member 10421 is configured to be housed inside the second annular member 1042 and cooperates with the inner tube 1021 of the motor assembly 103 and the composite sleeve to ensure that the inner surfaces of the motor assembly 103, the second positioning member 10421, and the composite sleeve 102 are on the same surface and the connection is tightly fitted, thereby making the inlet tube, the composite sleeve, and the motor assembly form a complete and smooth inner surface without gaps or dimensional changes.
[0071] Specifically, please see Figure 9-11 The distal end face of the first positioning member 10411 abuts against the proximal end face of the inlet tube 101, and the proximal end face of the first positioning member 10411 abuts against the distal end face of the inner tube 1021. The thickness of the first positioning member 10411 is d2, and the thickness of the part of the inlet tube 101 extending into the first annular member 1041 is also d2. Furthermore, the total thickness of the first annular member 1041 itself plus d2 is the thickness of the inner tube 1021, so that the inner surface connection of the inlet tube 101, the first positioning member 10411, and the inner tube 1021 is located on the same surface, and the connection is tightly fitted, forming a smooth connection and an inner surface without dimensional changes.
[0072] The proximal end face of the second positioning member 10421 abuts against the distal end face of the motor assembly 103, and the distal end face of the second positioning member 10421 abuts against the proximal end face of the inner tube 1021. The thickness of the second positioning member 10421 is d2, and the thickness of the portion of the motor assembly 103 extending into the second annular member 1042 is also d2. Furthermore, the total thickness of the second annular member 1042 itself plus d2 is the thickness of the inner tube 1021, so that the connection point of the inner surfaces of the motor assembly 103, the second positioning member 10421, and the inner tube 1021 is located on the same surface, and the connection point fits tightly, forming a smooth connection and an inner surface without dimensional changes.
[0073] As one embodiment, the receiving component includes a first receiving component 10412 and a second receiving component 10422. The first receiving component 10412 and the second receiving component 10422 have the same structure and equal dimensions, and are both hollow tubular structures. Please refer to [link / reference]. Figure 7 The first receiving member 10412 is configured to be fixed to the outside of the first annular member 1041 and cooperates with the inlet tube 101 and the extension member 105 to ensure that the outer surfaces of the inlet tube 101, the first receiving member 10412, and the composite sleeve 102 are on the same surface and the connection is tightly fitted; the second receiving member 10422 is configured to be fixed to the outside of the second annular member 1042 and cooperates with the motor assembly 103 and the extension member 105 to ensure that the outer surfaces of the motor assembly 103, the second receiving member 10422, and the composite sleeve 102 are on the same surface and the connection is tightly fitted, so that the inlet tube 101, the composite sleeve 102, and the motor assembly 103 form a complete and smooth outer surface without gaps or dimensional changes.
[0074] Specifically, see Figure 7 , 8 The extension 105 is housed between the proximal end face of the first receiving member 10412 and the distal end face of the second receiving member 10422. The thickness of the extension 105 perpendicular to the extension direction of the tube body is the same as the thickness of the first receiving member 10412, the second receiving member 10422, and the outer tube 1022, which is d1. This ensures that the outer surfaces of the first receiving member 10412, the extension 105, the outer tube 1022, and the second receiving member 10422 are on the same surface and that the connection is tightly fitted, so that the first receiving member 10412, the extension 105, the outer tube 1022, and the second receiving member 10422 form a smooth connection with no dimensional change in the outer surface.
[0075] Specifically, the inlet tube 101 is provided with a first end face 1013, which is perpendicular to the extension direction of the inlet tube 101; the motor assembly 103 is provided with a second end face 1035, which is perpendicular to the extension direction of the motor assembly 103; the total thickness of the first annular member 1041 plus d1 is the thickness of the first end face 1013. Thus, the outer surfaces of the inlet tube 101, the first receiving member 10412, the extension member 105 and the outer tube 1022 are located on the same surface, and the connection is tightly fitted, forming a smooth connection and an outer surface without dimensional changes. The first receiving member 10412 realizes a smooth transition at the nested part of the inlet tube 101 and the extension member 105.
[0076] The second end face 1035 is perpendicular to the extension direction of the motor assembly 103. The total thickness of the second end face 1035 is the thickness of the second annular member 1042 plus d1. Thus, the outer surfaces of the motor assembly 103, the second receiving member 10422, the extension member 105 and the outer tube 1022 are on the same surface and the connection is tightly fitted, forming a smooth connection and an outer surface without dimensional changes. The second receiving member 10422 realizes a smooth transition at the nested part of the motor assembly 103 and the extension member 105.
[0077] In one embodiment, please refer to Figure 13 , 14 The inlet tube 101 is provided with a first engaging surface 1014, and the motor assembly 103 is provided with a second engaging surface 1036. The first engaging surface 1014 and the second engaging surface 1036 are respectively used to extend into the inner holes of the first annular member 1041 and the second annular member 1042, so that the first positioning member 10411 abuts against the proximal end face of the inlet tube 101 and the second positioning member 10421 abuts against the distal end face of the motor assembly 103. Specifically, the first engaging surface 1014 is provided on the proximal side of the inlet tube 101 and is an annular plane cut from the outer surface of the inlet tube 101. The diameter of the first engaging surface 1014 is not greater than the diameter of the inlet tube 101. When the inlet tube 101 and the first annular member 1041 are nested, the first engaging surface 1014 abuts against the inner surface of the inner hole of the first annular member 1041, so that the proximal end face of the inlet tube 101 abuts against the first positioning member 10411. The second snap-fit surface 1036 is disposed on the far side of the motor assembly 103 and is an annular plane cut from the outer surface of the motor assembly 103. The diameter of the second snap-fit surface 1036 is not greater than the diameter of the motor assembly 103. When the motor assembly 103 and the second annular member 1042 are nested, the second snap-fit surface 1036 abuts against the inner surface of the inner hole of the second annular member 1042, so that the far end face of the motor assembly 103 abuts against the second positioning member 10421.
[0078] In another embodiment, the composite sleeve 102 further includes a reinforcing tube 1023, see [link to relevant documentation]. Figure 3 The reinforcing tube 1023 is used to increase the strength of the composite sleeve 102 and to provide support for the outer tube 1022. The outer tube 1022 is located outside the reinforcing tube 1023 to protect the reinforcing tube 1023 and the inner tube 1021 and to increase the lubricity of the composite sleeve 102. The outer tube 1022, the reinforcing tube 1023 and the inner tube 1021 have the same axial length.
[0079] In one embodiment, the composite sleeve 102 comprises, from the inside out, an inner tube 1021, a reinforcing tube 1023, and an outer tube 1022. When the inlet tube 101 is assembled with the first annular member 1041, optionally, the total thickness of the first positioning member 10411 plus the thickness of the first annular member 1041 is equal to the sum of the thickness of the inner tube 1021 and the thickness of the reinforcing tube 1023. When the motor assembly 103 is assembled with the second annular member 1042, optionally, the total thickness of the second positioning member 10421 plus the thickness of the second annular member 1042 is equal to the sum of the thickness of the inner tube 1021 and the thickness of the reinforcing tube 1023.
[0080] Specifically, the reinforcing tube 1023 is made of shape memory alloy wire, which increases the strength of the outer tube 1022 and provides support for bending deformation when the composite cannula 102 passes through the aortic arch. The outer tube 1022 is made of a smooth polymer material and wraps around the reinforcing tube 1023. The wall thickness is 0.02-0.5 mm, preferably 0.05-0.2 mm. The outer tube 1022 protects the structure of the reinforcing tube 1023 and the inner tube 1021, ensures the smoothness of the surface of the composite cannula 102, and increases the wettability of the outer tube 1022.
[0081] In the embodiments of this application, the inlet pipe 101 is as follows: Figure 13 As shown, it also includes a guide end 1011 and an inlet 1012. The guide end 1011 includes a tip located at the distal end and a ball end protruding towards the inlet 1012. The tip is conical in design, mainly to reduce the resistance between the catheter pump and the blood when inserted into the human body, allowing the catheter pump 100 to reach the left ventricle more smoothly. The ball end is hemispherical in design, which is intended to allow blood to flow smoothly around the flow lines on the surface of the ball end into the inlet 1012, reducing blood accumulation and preventing thrombus formation.
[0082] Inlet 1012 is the channel for blood to enter the composite sheath 102. Optionally, there can be 2-8 inlets, preferably 3-4. In this embodiment, there are 4 inlets, which is easy to process and ensures the window area. A first end face 1013 is cut or ground on the tube body near the proximal end of the inlet tube 101. The first end face 1013 has a certain thickness in the direction perpendicular to the axial extension of the inlet tube 101. This thickness cooperates with the first receiving part 10412 of the first annular part 1041 to achieve guidance and axial positioning when the inlet tube 101 and the composite sheath 102 are nested, ensuring that the outer diameters of the inlet tube 101 and the first annular part 1041 are equal. A first snap-fit surface 1014 is formed by cutting or grinding the tube body near the proximal end of the inlet tube 101. The first snap-fit surface 1014 is disposed between the first end face 1013 and the proximal end face of the inlet tube 101. The first snap-fit surface 1014 is disposed perpendicular to the first end face 1013 and the proximal end face of the inlet tube 101 and is used to abut against the inner surface of the inner hole of the first annular member 1041.
[0083] As an example, please refer to Figure 14 The motor assembly 103 of this solution includes an impeller 1031, a pump housing 1032, and a motor 1033. The impeller 1031 is housed in the pump housing 1032. The rotation of the motor 1033 drives the impeller 1031 to rotate circumferentially, thereby driving blood from the inlet pipe 101 into the conduit pump 100. The pump housing 1032 is used to rectify the blood flowing through the impeller 1031 and prevent the blood from spreading circumferentially due to the rotational force.
[0084] Specifically, the impeller 1031 is housed within the pump casing 1032, which has an outlet 10321. When the motor 1033 is started, it drives the impeller 1031 to rotate. The rotating impeller 1031 draws in blood, which flows through the guide end 1011 and enters the duct pump 100 through the inlet 1012 of the inlet pipe 101. As the blood flows through the impeller 1031, it is diffused circumferentially by the rotational force. The pump casing 1032 rectifies the rotating blood, causing it to flow axially through the impeller 1031 and finally exit at the pump casing outlet 10321. This achieves the purpose of transferring blood from the left ventricle of the heart to the aorta.
[0085] Specifically, the outer surface of the motor 1033 is provided with a first slot 10331, and the outer surface of the pump housing 1032 is provided with an extension slot 10322. The first slot 10331 and the extension slot 10322 are used to accommodate a pressure sensor, which is used to monitor blood pressure. Specifically, the first slot 10331 and the extension slot 10322 are connected. The first slot 10331 extends from the proximal end of the motor 1033 to the distal end of the motor 1033, and the extension slot 10322 extends from the proximal end of the pump housing 1032 to the distal end of the pump housing 1032, passes over the pump housing outlet 10321, and terminates at any position between the pump housing outlet 10321 and the second end face 1035. The pressure sensor extends from the proximal end of the first slot 10331 to the distal end of the first slot 10331, passing the connection point between the first slot 10331 and the extension slot 10322, and continues to extend to the distal end of the extension slot 10322, ending at the farthest end of the extension slot 10322. The pressure sensor includes a pressure probe disposed at the farthest end of the extension slot 10322. The pressure probe is used to monitor the blood pressure flowing out of the pump housing outlet 10321, and its placement reduces the impact of blood on the pressure probe.
[0086] In one embodiment, the motor assembly further includes a tail cap 1034, which has a second slot 10341 for a pressure sensor to extend and enter a first slot 10331 and an extension slot 10322. Specifically, the tail cap 1034 is located at the proximal end of the motor assembly and has a flared hollow structure, including a distal end face and a proximal end face. The second slot 10341 starts from the distal end face of the tail cap 1034 and extends to the main body of the tail cap 1034 (not extending to the proximal end face). The shape of the second slot 10341 can be rectangular, elliptical, or other structures that allow the pressure sensor to pass through; no specific limitation is made here. The width of the second slot 10341 is also not specifically limited; in this embodiment, the width of the second slot 10341 is set to 1 mm.
[0087] See Figure 17 The impeller 1031 has a hub 10311 and blades 10312. The blades 10312 are disposed on the outside of the hub 10311. In one embodiment, the impeller 1031 includes a hub 10311 and blades 10312 disposed around the axis of the hub 10311. The hub 10311 is configured as a conical structure, including a guide head end and a hub body. The guide head end is used to guide blood. The hub body extends towards the side close to the motor 1033 and the diameter of the hub body gradually increases. The motor 1033 is provided with a motor surface 10332. The inclination of the motor surface 10332 relative to the axis of the motor 1033 is the same as the inclination of the surface of the hub body relative to the axis of the hub body.
[0088] Specifically, the hub 10311 is designed with a conical structure, and its diameter gradually increases from the distal end to the proximal end. In particular, the hub 10311 includes a guide head and a hub body. The guide head, which is arc-shaped, is located at the distal end of the hub 10311 to guide blood flow as it passes through the impeller 1031. The arc-shaped design allows for smoother blood flow and prevents blood accumulation at this point. The proximal end of the hub 10311 is connected to the motor 1033. The distal end of the motor 1033 has a motor curved surface 10332, as shown in the reference section. Figure 17 As shown, the curved surface of the hub body and the curved surface 10332 of the motor have the same slope to ensure a smooth transition of blood flow without turbulence. Specifically, the angle of the slope can be designed to be 20-60 degrees. The design protected by this invention includes, but is not limited to, a slope design; a curved transition can also be used, where the curved surface of the hub body and the curved surface 10332 of the motor have the same radius of curvature, which also ensures a smooth transition.
[0089] The present invention also provides a ventricular assist device, including a catheter pump 100 and a delivery catheter 200, the delivery catheter 200 being signal-connected to the catheter pump 100, the delivery catheter 200 having a receiving cavity for receiving a wire signal-connected to the catheter pump 100.
[0090] See Figure 18 The delivery catheter 200 provided in one embodiment of this application is used in a patient's blood vessels. The delivery catheter 200 is used to deliver other devices or substances for treating the patient. The delivery catheter 200 includes an inner liner 201, a support layer 202, and an outer sheath 203.
[0091] The inner liner tube 201 has a receiving cavity 2011 for accommodating articles. In actual use, other devices or substances for treating patients are disposed within the receiving cavity 2011 of the inner liner tube 201. A support layer 202 is disposed outside the inner liner tube 201 to support the delivery catheter 200 and improve its support. The support layer 202 includes a braided layer 2021, which is a tubular structure formed by winding at least one strand of braided yarn. This arrangement ensures that the braided layer 2021 does not obstruct the inner diameter of the inner liner tube 201. An outer sheath 203 is disposed outside the support layer 202. On the one hand, the outer sheath 203 protects the braided layer 2021; on the other hand, the outer sheath 203 does not obstruct the inner diameter of the inner liner tube 201.
[0092] It should be noted that the braided layer 2021 in this application is tubularly disposed on the outside of the inner liner tube 201. With the above-mentioned arrangement, the braided layer 2021 does not restrict the size of the inner cavity 2011 formed inside the inner liner tube 201. On the other hand, the thickness of the braided layer 2021 is controllable, which makes it easier to reduce the outer diameter of the entire delivery catheter 200. This allows the outer diameter of the delivery catheter 200 to be set in the range of 2F (feet) to 3F, thereby facilitating the installation of the delivery catheter 200 in the blood vessel and reducing the impact of the delivery catheter 200 on the patient. At the same time, the braided layer 2021 increases the overall rigidity of the delivery catheter 200, which can reduce the pushing force when the delivery catheter 200 is pushed into the blood vessel.
[0093] In one embodiment, the ventricular assist device further includes a controller 300 and a flushing system 400. The controller 300 is signal-connected to the catheter pump 100 and the flushing system 400 and is used to adjust the operating parameters of the catheter pump 100 and the flushing system 400. The flushing system 400 is fluidly connected to the catheter pump 100 and is used to flush the catheter pump 100 during operation.
[0094] Specifically, please see Figure 19 The flushing system 400 includes a flushing fluid line 401, an accumulator 402, and an air filter 403. The accumulator 402 and the air filter 403 are fixed to the flushing fluid line 401. The accumulator 402 provides flushing pressure to the flushing fluid, and the air filter 403 filters out air to prevent it from entering the conduit pump 100. Specifically, the accumulator 402 and the air filter 403 are in fluid communication with the flushing fluid line 401. The flushing fluid first flows from the flushing fluid line 401 into the accumulator 402. The accumulator 402 regulates the flushing fluid pressure and drives the flushing fluid to continue flowing towards the air filter 403. The air filter 403 can monitor air bubbles in the flushing fluid and uses a filter membrane to discharge the air bubbles into the air, preventing air bubbles from entering the conduit pump 100.
[0095] In one embodiment, the flushing system further includes a flushing fluid bag 404, a puncture device 405, and a drive box 406. The puncture device 405 is inserted into the flushing fluid bag 404 and fixedly connected to the flushing fluid line 401 so that the drive box 406 drives the flushing fluid to flow from the flushing fluid bag 404 into the flushing fluid line 401.
[0096] Please see Figure 1 The drive box 406 is fixed to the controller 300. One end of the flushing fluid line 401 is connected to the flushing fluid bag 404, and the other end extends into the delivery conduit 200 and finally connects to the conduit pump 100. The controller 300 controls the flushing fluid to flow out of the flushing fluid bag 404. The flushing fluid flows through the puncture device 405, the flushing fluid line 401, the accumulator 402, the air filter 403, and finally flows into the conduit pump 100 along the flushing fluid line 401.
[0097] In another embodiment, the ventricular assist device further includes a sensor cable for connecting a pressure sensor and a controller 300, and transmitting pressure data measured by the pressure sensor to the controller 300.
[0098] In one embodiment, the catheter pump 100 is connected to the controller 300 via a wire. In particular, the ventricular assist device also includes a handle, and the wires, sensor cables, and flushing fluid lines 401 are integrated at the handle and uniformly housed in the delivery catheter 200 at the handle, and are connected to the catheter pump 100 via the delivery catheter 200.
[0099] The above description is merely an embodiment of this application and does not limit the patent scope of this application. Any equivalent structural or procedural transformations made using the content of this application's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of this application.
Claims
1. A clamping assembly for connecting tubing in a ventricular assist device, the tubing comprising a first tube and a second tube, the first tube and the second tube being connected via the clamping assembly, characterized in that, The clamping assembly includes an elastic extension and an elastic ring; the extension is fixed to one end of the second tube and, in its natural state, the outer diameter of the extension is the same as the outer diameter of the second tube. When the first tube and the second tube are connected by a clamping assembly, at least a portion of the first tube is housed inside the annular member, which has an inward clamping force that fixes the first tube to the annular member; the extension fixed to one end of the second tube is clamped to at least a portion of the area outside the annular member, which has an inward clamping force that fixes the extension to the annular member. After the annular component is assembled with the first tube and the extension component is assembled with the annular component, the outer surfaces of the annular component, the extension component, the first tube and the second tube are located on the same surface and the connection is tightly fitted. The inner surfaces of the annular component, the first tube and the second tube are located on the same surface and the connection is tightly fitted. The clamping assembly further includes a positioning element and a receiving element. The positioning element is disposed at one end of the inner surface of the annular element and is clamped inward by the clamping force of the annular element. One end of the positioning element abuts against the first tube, and the other end of the positioning element abuts against the second tube. The inner surface of the positioning element is located on the same surface as the inner surfaces of the first tube and the second tube, and the connection is tightly fitted, so that the connection between the first tube, the positioning element, and the second tube forms a complete and smooth inner surface without gaps or dimensional changes. The receiving component is fixed to the outer surface of the annular component and to the opposite end of the positioning component. One end of the receiving component abuts against the first tube, and the other end abuts against the extension component. After the receiving component and the extension component are assembled, the outer surfaces of the receiving component, the extension component, the first tube, and the second tube are located on the same surface, and the connection is tightly fitted, so that the connection of the first tube, the receiving component, the extension component, and the second tube forms a complete and smooth outer surface without gaps or dimensional changes.
2. The clamping assembly according to claim 1, characterized in that, The second tube is configured as a tube structure with no less than two layers. The second tube includes an outer tube and an inner tube. The extension is fixed to one end of the outer tube and the extension has the same outer diameter as the outer tube. The inner tube abuts against one end of the positioning member and the inner diameter of the inner tube has the same inner diameter as the positioning member.
3. A catheter pump for ventricular assist therapy, comprising: The catheter pump comprises an inlet tube, a composite cannula, and a motor assembly. Blood flows in through the inlet tube, passes through the composite cannula, and exits from the motor assembly. The motor assembly is configured to provide driving force for the blood flow. The conduit pump further includes a clamping assembly comprising an elastic extension and an elastic annular member. The extension is fixed to both ends of the composite sleeve. The inlet pipe and at least a portion of the motor assembly are tightly clamped inside the annular member, and at least a portion of the annular member is tightly clamped inside the extension. This ensures that the inner surfaces of the inlet pipe, the composite sleeve, and the motor assembly are on the same surface and that the connections are tightly fitted. It also ensures that the outer surfaces of the inlet pipe, the composite sleeve, and the motor assembly are on the same surface and that the connections are tightly fitted. This results in the inlet pipe, the composite sleeve, and the motor assembly forming a complete, smooth inner and outer surface without gaps or dimensional variations. The clamping assembly further includes a positioning member and a receiving member. At least a portion of the positioning member is tightly clamped inside the annular member and is used to smoothly connect the inlet tube to the inner tube of the composite sleeve, and the inner tube of the composite sleeve to the motor assembly. At least a portion of the receiving member is disposed outside the annular member and is used to smoothly connect the inlet tube to the extension member, and the extension member to the motor assembly.
4. The duct pump according to claim 3, characterized in that, The annular component is configured as a hollow annular structure, and the annular component includes a first annular component and a second annular component. At least a portion of the inlet tube is tightly clamped inside the first annular component, at least a portion of the motor assembly is tightly clamped inside the second annular component, and at least a portion of the first annular component and the second annular component are tightly clamped inside the extension component.
5. The duct pump according to claim 4, characterized in that, The positioning element includes a first positioning element and a second positioning element. The first positioning element is configured to be housed inside the first annular element and cooperates with the inner tube of the inlet tube and the composite sleeve to ensure that the inner surfaces of the inlet tube, the first positioning element, and the composite sleeve are located on the same surface and the connection is tightly fitted. The second positioning element is configured to be housed inside the second annular element and cooperates with the inner tube of the motor assembly and the composite sleeve to ensure that the inner surfaces of the motor assembly, the second positioning element, and the composite sleeve are located on the same surface and the connection is tightly fitted, thereby making the inlet tube, the composite sleeve, and the motor assembly form a complete and smooth inner surface without gaps or dimensional changes.
6. The duct pump according to claim 3, characterized in that, The receiving component includes a first receiving component and a second receiving component. The first receiving component is configured to be fixed to the outside of the first annular component and cooperates with the inlet tube and the extension component to ensure that the outer surfaces of the inlet tube, the first receiving component, and the composite sleeve are located on the same surface and the connection is tightly fitted. The second receiving component is configured to be fixed to the outside of the second annular component and cooperates with the motor assembly and the extension component to ensure that the outer surfaces of the motor assembly, the second receiving component, and the composite sleeve are located on the same surface and the connection is tightly fitted, thereby making the inlet tube, the composite sleeve, and the motor assembly form a complete and smooth outer surface without gaps or dimensional changes.
7. The duct pump according to claim 5, characterized in that, The distal end face of the first positioning member abuts against the proximal end face of the inlet tube, and the proximal end face of the first positioning member abuts against the distal end face of the inner tube. The thickness of the portion of the inlet tube extending into the first annular member is the same as the thickness of the first positioning member. The inner surfaces of the inlet tube, the first positioning member, and the inner tube are located on the same surface, and the connection is tightly fitted to form a smooth connection and an inner surface without dimensional changes. The proximal end face of the second positioning member abuts against the distal end face of the motor assembly, and the distal end face of the second positioning member abuts against the proximal end face of the inner tube. The thickness of the portion of the motor assembly extending into the second annular member is the same as the thickness of the second positioning member. The inner tube, the second positioning member, and the inner surface of the motor assembly are located on the same surface, and the connection is tightly fitted to form a smooth connection and an inner surface without dimensional changes.
8. The duct pump according to claim 6, characterized in that, The extension is housed between the proximal end face of the first receiving member and the distal end face of the second receiving member. The thickness of the extension in the direction perpendicular to the extension of the tube is the same as the thickness of the first receiving member and the second receiving member to ensure that the outer surfaces of the first receiving member, the extension, and the second receiving member are located on the same surface and that the connection is tightly fitted, so that the first receiving member, the extension, and the second receiving member form a smooth connection with no dimensional change in the outer surface.
9. The duct pump according to claim 8, characterized in that, The inlet tube is provided with a first end face, and the motor assembly is provided with a second end face. The first end face abuts against the distal end face of the first receiving member. The thickness of the first end face along the extension direction perpendicular to the inlet tube is the same as the sum of the thicknesses of the first receiving member and the first annular member, so that the outer surfaces of the inlet tube, the first receiving member, the extension member, and the outer tube are located on the same surface, and the connection is tightly fitted to form a smooth connection and an outer surface without dimensional changes. The second end face abuts against the proximal end face of the second receiving member. The thickness of the second end face along the extension direction perpendicular to the motor assembly is the same as the sum of the thicknesses of the second receiving member and the second annular member, so that the outer surfaces of the motor assembly, the second receiving member, the extension member, and the outer tube are flush, forming a smooth connection and an outer surface without dimensional changes.
10. The duct pump according to claim 6, characterized in that, The inlet tube is provided with a first snap-fit surface, and the motor assembly is provided with a second snap-fit surface. The first snap-fit surface is tightly clamped in the inner hole of the first annular member, and the second snap-fit surface is tightly clamped in the inner hole of the second annular member, so that the distal end face of the first receiving member abuts against the proximal end face of the inlet tube, and the proximal end face of the second receiving member abuts against the distal end face of the motor assembly.
11. The duct pump according to claim 3, characterized in that, The composite sleeve also includes a reinforcing tube, which is used to increase the strength of the composite sleeve and provide support for the outer tube; the outer tube is disposed outside the reinforcing tube to protect the reinforcing tube and the inner tube, and to increase the lubricity of the composite sleeve.
12. The duct pump according to claim 3, characterized in that, The inlet tube also includes a guide end and an inlet. The guide end includes a tip located at the distal end and a ball end protruding towards the inlet. The tip is used to reduce the resistance of the catheter pump when it enters the human body, and the ball end is used to guide the blood into the inlet.
13. The duct pump according to claim 3, characterized in that, The motor assembly includes an impeller, a pump housing, and a motor. The impeller is housed within the pump housing. The rotation of the motor drives the impeller to rotate circumferentially, thereby driving blood from the inlet pipe into the duct pump. The pump housing is used to rectify the blood flowing through the impeller and prevent the blood from spreading circumferentially due to rotational force.
14. The duct pump according to claim 13, characterized in that, The outer surface of the motor is provided with a first slot, and the outer surface of the pump housing is provided with an extension slot. The first slot and the extension slot are used to accommodate a pressure sensor, which is used to monitor blood pressure.
15. The duct pump according to claim 14, characterized in that, The motor assembly also includes a tail cover, which has a second slot for the pressure sensor to extend and enter the first slot and the extension slot.
16. The duct pump according to claim 13, characterized in that, The impeller includes a hub and blades arranged around the hub axis. The hub is configured as a conical structure, including a guide head end and a hub body. The guide head end is used to guide blood flow, and the hub body extends towards the motor side and the diameter of the hub body gradually increases. The motor is provided with a motor curved surface, and the inclination of the motor curved surface relative to the motor axis is the same as the inclination of the curved surface of the wheel hub body relative to the wheel hub body axis.
17. A ventricular assist device, characterized in that, The duct pump included in any one of claims 3-16.
18. The ventricular assist device according to claim 17, characterized in that, It also includes a delivery conduit, which is signal-connected to the conduit pump. The delivery conduit includes an inner liner, a support layer, and an outer sheath. The inner liner has a receiving cavity for receiving the wires signal-connected to the conduit pump. The support layer is used to improve the support of the delivery conduit. The outer sheath is used to protect the support layer.
19. The ventricular assist device according to claim 17, characterized in that, It also includes a controller and a flushing system. The controller is signal-connected to the duct pump and the flushing system and is used to adjust the operating parameters of the duct pump and the flushing system. The flushing system is fluidly connected to the duct pump and is used to flush the duct pump during its operation.
20. The ventricular assist device according to claim 19, characterized in that, The flushing system includes a flushing fluid pipeline, an accumulator, and an air filter. The accumulator and the air filter are fixed to the flushing fluid pipeline. The accumulator is used to provide flushing pressure to the flushing fluid, and the air filter is used to filter out air and prevent the air from entering the conduit pump.
21. The ventricular assist device according to claim 20, characterized in that, The flushing system also includes a flushing fluid bag, a puncture device, and a drive box. The puncture device is inserted into the flushing fluid bag and fixedly connected to the flushing fluid pipeline so that the drive box drives the flushing fluid to flow from the flushing fluid bag into the flushing fluid pipeline.