Mechanical thrombectomy catheter device

Abstract

The utility model relates to a kind of mechanical thrombectomy catheter device, its mechanical thrombectomy catheter assembly, the catheter assembly includes inner tube, intermediate tube, outer tube and cutting part, intermediate tube is movably sleeved on inner tube, outer tube is movably sleeved on intermediate tube, cutting part is sleeved on the distal end of inner tube, and distal end is fixedly connected with inner tube, proximal end is fixedly connected with intermediate tube, cutting part includes outer layer support, cutting unit located in the inside of outer layer support and connecting piece, cutting unit has cutting port, the projection of cutting unit on inner tube is closed figure structure, cutting part has radial shrinkage state and radial expansion state, when it is in radial expansion state, the overall of outer layer support is substantially spindle shape structure, cutting hole is located in the inside middle part of spindle shape structure and there is a distance between cutting hole and inner tube, when it is in radial shrinkage state, it is close to inner tube, it can be received in outer tube. The utility model can improve the cutting effect of thrombus in radial direction.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, specifically to a mechanical thrombectomy catheter device. Background Technology

[0002] A thrombus is a solid mass of blood that abnormally clots within a blood vessel. It is typically composed of platelets, fibrin, red blood cells, and white blood cells. Thrombi can block blood vessels, leading to ischemia, hypoxia, and even necrosis of the tissues or organs supplied by those vessels. For example, arterial thrombosis can cause necrosis of the myocardium or brain tissue, while venous thrombosis can cause swelling and pain in the limbs. If a thrombus breaks off and enters the bloodstream, it may block blood vessels in other parts of the body, causing embolism, such as pulmonary embolism or cerebral embolism. Common treatments include using thrombolytic drugs to dissolve the thrombus, using anticoagulants to prevent its spread, and restoring vascular patency through surgical thrombectomy or interventional procedures. Surgical thrombectomy and interventional procedures are primarily used for larger thrombi or patients for whom thrombolysis is ineffective. Mechanical thrombectomy catheters are widely used in surgical thrombectomy and interventional procedures. Their working principle is mainly to directly remove thrombi from blood vessels through physical means, including mechanical cutting and / or aspiration.

[0003] Traditional mechanical thrombectomy devices use rotary blades, which can easily rub and scrape against the vessel wall during thrombectomy, causing damage to the vessel wall and, in severe cases, even leading to vessel perforation, bleeding, or serious complications. Existing stent or mesh thrombectomy devices primarily use expandable stents made of shape-memory metal wires to make close contact with the vessel wall, scraping off and removing the thrombus. This results in less damage to the vessel wall, as seen in patents such as CN218792404U, CN115530924B, and CN215960137U. However, these existing stent or mesh thrombectomy devices effectively improve the radial cutting effect of the thrombus. Summary of the Invention

[0004] The purpose of this invention is to provide a mechanical thrombectomy catheter device that can improve the radial cutting effect of thrombi.

[0005] To achieve the above objectives, the technical solution adopted by this utility model is as follows:

[0006] The first aspect of this utility model provides a mechanical thrombectomy catheter assembly, comprising an inner tube, a middle tube, an outer tube, and a cutting component. The inner tube has a guidewire lumen extending from one end to the other for a guidewire to pass through. The middle tube is movably fitted onto the inner tube in a proximal-distal direction, with the distal end of the inner tube extending beyond the distal end of the middle tube. The outer tube is movably fitted onto the middle tube in a proximal-distal direction, and a fluid channel for drug delivery or thrombus aspiration is formed between the middle tube and the outer tube. The cutting component is fitted onto the distal end of the inner tube, with its distal end fixedly connected to the inner tube and its proximal end fixedly connected to the distal end of the middle tube. The cutting component includes an outer support, a cutting unit located inside the outer support, and a connector for fixing the cutting unit to the outer support. The cutting unit has a cutting opening, and its projection onto the inner tube forms a closed geometric structure.

[0007] The cutting component has a radially contracted state and a radially expanded state. By adjusting the distance between the distal end of the inner tube and the distal end of the intermediate tube, the cutting component can switch between the radially contracted state and the radially expanded state.

[0008] When the cutting component is in the radially expanded state, the outer support is generally spindle-shaped, and the cutting unit is located in the middle of the spindle-shaped structure and is a distance away from the inner tube.

[0009] When the cutting component is in the radially contracted state, the cutting component moves closer to the inner tube and can be housed inside the outer tube.

[0010] In a specific embodiment, the distal end of the inner tube always extends beyond the distal end of the intermediate tube. When the cutting component is in a radially contracted state, the length of the inner tube extending beyond the distal end of the intermediate tube is the longest, and when the cutting component is in a radially expanded state, the length of the inner tube extending beyond the distal end of the intermediate tube is the shortest.

[0011] In a specific embodiment, similar to existing stent thrombectomy devices in the art, the outer stent also has a cutting function. When the cutting component is in a radially expanded state, the inner tube and the intermediate tube move simultaneously in the proximal direction, and the cutting component cuts the thrombus in the axial direction; simultaneously, the inner tube and the intermediate tube are rotated, and the cutting component cuts the thrombus in the radial direction.

[0012] In some embodiments, the axial length of the cutting member in the radially expanded state is less than its axial length in the radially contracted state.

[0013] In some embodiments, the outer support includes a first variable diameter portion, a constant diameter portion, and a second variable diameter portion that are sequentially connected or integrally formed from its proximal end to its distal end. When the cutting component is in the radially expanded state, the outer diameter of the first variable diameter portion remains constant from the proximal end to the distal end, then gradually increases, and then remains constant again. The outer diameter of the second variable diameter portion remains constant from the proximal end to the distal end, then gradually decreases, and then remains constant again. The outer diameter of the constant diameter portion is equal to the distal outer diameter of the first variable diameter portion and equal to the proximal outer diameter of the second variable diameter portion.

[0014] According to some specific embodiments, the first variable diameter section includes multiple linear first ribs arranged at intervals along the circumference of the inner tube; the second variable diameter section includes multiple linear second ribs arranged at intervals along the circumference of the inner tube. The constant diameter section has an annular structure with multiple deformable support units connected in sequence along its circumference. Each support unit has a through hole. When the cutting component transitions from the radially contracted state to the radially expanded state, the length of the through hole gradually decreases in the direction parallel to the axis of the constant diameter section, and gradually increases in the circumferential direction of the constant diameter section. The proximal end of the support unit is fixedly connected to or integrally formed with the distal end of the first rib, and the distal end of the support unit is fixedly connected to or integrally formed with the proximal end of the second rib. The support unit can improve the contact between the cutting component and the blood vessel wall, providing better support force, and is also easily deformable, facilitating the transition of the cutting component between the radially contracted state and the radially expanded state.

[0015] More specifically, the equal-diameter portion includes a third and a fourth rib, each forming a wavy ring. The third and fourth ribs are symmetrically arranged, each having staggered crests and troughs in the circumferential direction. The trough of the third rib is fixedly connected to or integrally formed with the distal end of the first rib. The crests of the third rib and the troughs of the fourth rib are fixedly connected to or integrally formed with the proximal end of the second rib. The number of crests and troughs of the first, second, third, and fourth ribs are equal and connected in a one-to-one correspondence, thus eliminating free ends in the first and second ribs and preventing damage to the blood vessel wall.

[0016] In some embodiments, the connector has a linear structure, with one end fixedly connected to the outer support and the other end connected to the cutting unit. The connector gradually moves away from the outer support and closer to the inner tube from the end connected to the outer support to the other end.

[0017] In some specific embodiments, the proximal end of the connector is fixedly connected to or integrally formed with the proximal end of the support unit, and the distal end of the connector is fixedly connected to or integrally formed with the proximal end of the cutting unit. The connector gradually tilts towards the inner tube from its proximal end to its distal end. When the cutting component is in a radially expanding state, the tilt angle is 10°-30°, for example, 10°, 11°, 12°, 13°, 14°, 15°, 16°, 17°, 18°, 19°, 20°, 21°, 22°, 23°, 24°, 25°, 26°, 27°, 28°, 29°, or 30°.

[0018] Furthermore, the proximal end of the connector is fixedly connected to the trough of the third rib and / or the distal end of the first rib, or integrally formed therefrom.

[0019] In some embodiments, an optical fiber channel is further provided within the wall of the outer tube, through which an optical fiber is threaded. A pressure sensor is also located at the distal end of the outer tube wall, and the pressure sensor is electrically connected via an optical fiber to an FFR device located near the proximal end of the outer tube. The pressure sensor is used to monitor pressure in real time and provide the data to the FFR device for calculation and output of the fractional flow reserve (FFR). FFR can be used to indicate vascular blood supply status or revascularization status.

[0020] To improve the sensitivity and accuracy of pressure detection, the outer tube is preferably made of one or more of the following materials: PTFE (polytetrafluoroethylene), PU (polyurethane), Pebax (block polyether amide resin), nylon (polyamide), TPU (thermoplastic polyurethane), and PE (polyethylene).

[0021] In some embodiments, the number of cutting units is one or more, and the plurality of cutting units are distributed at circumferential intervals along the cutting component.

[0022] In this invention, the number of cutting units can be adjusted according to actual needs. While not affecting the radial shrinkage and storage of the cutting component in the outer tube, the number of cutting units or the cutting area of ​​the cutting units can be increased as much as possible. This improves the radial cutting effect on the thrombus and prevents the cutting component from being easily shrunk into the outer tube due to the presence of the cutting units.

[0023] In a specific embodiment, the shape of the cut is one or more of the following: rhombus, circle, or square.

[0024] In a specific implementation, each of the connectors is connected to one of the cutting units, and the cutting component does not have a separate rib with a free end, so as to avoid puncturing the inner wall of the blood vessel when it contracts radially.

[0025] In a specific embodiment, the area of ​​the cut is 4-16 mm. 2 For example, 4mm 2 5mm 2 6mm 2 7mm 2 8mm 2 9mm 2 10mm 2 11mm 2 12mm 2 13mm 2 14mm 2 15mm 2 Or 16mm 2 .

[0026] In a specific embodiment, when the cutting component is in a radially expanded state, the area of ​​the support unit is 4 to 10 times the area of ​​the cutting opening, for example, 4 times, 4.5 times, 5 times, 5.5 times, 6 times, 6.5 times, 7 times, 7.5 times, 8 times, 8.5 times, 9 times, 9.5 times, or 10 times.

[0027] In a specific implementation, the length of the connector is 2-6mm, for example 2mm, 3mm, 4mm, 5mm or 6mm.

[0028] In a specific embodiment, the axial length of the cutting component when it is in a radially contracted state is 1cm-5cm.

[0029] In a specific embodiment, the maximum outer diameter of the cutting component when it is in a radially expanded state is 0.5cm-3cm.

[0030] In a specific embodiment, the material of the cutting component is one or more of shape memory metal, shape memory alloy, and polymer.

[0031] In a specific embodiment, the inner tube is a rigid metal tube.

[0032] In a specific embodiment, the distal end of the inner tube is provided with a TIP head, which includes a conical head. The outer diameter of the conical head decreases from the proximal end to the distal end, and preferably the proximal outer diameter of the conical head is equal to the distal outer diameter of the outer tube.

[0033] In a specific embodiment, the intermediate tube is made of polymer or metal.

[0034] Specifically, the polymeric materials include, but are not limited to, PTFE, PU, ​​Pebax, nylon, TPU, and PE; the metallic materials include, but are not limited to, stainless steel and nickel-titanium alloys.

[0035] The second aspect of this utility model provides a mechanical thrombectomy catheter device, which includes the aforementioned mechanical thrombectomy catheter assembly, a first operating handle disposed at the proximal end of the inner tube and the intermediate tube, and a second operating handle disposed between the distal end of the outer tube and the outer wall of the proximal end of the intermediate tube. The first operating handle is used to control the movement of the inner tube in the intermediate tube and to lock the relative position of the inner tube and the intermediate tube. The second operating handle is used to control the movement of the outer tube on the intermediate tube, and the second operating handle is provided with a first channel communicating with the liquid channel. The first channel can be connected to an external aspiration device or an injection device through a flexible tube.

[0036] In other embodiments, a suitable aspiration catheter may be inserted through another passage.

[0037] In other embodiments, the second operating handle is further provided with a second channel connected to the optical fiber channel, through which the optical fiber passes and is connected to the FFR device.

[0038] In a specific embodiment, the mechanical thrombectomy catheter device further includes a guidewire.

[0039] In some preferred embodiments, the first operating handle has a certain space reserved along the axial direction of the inner tube, so that the proximal end of the inner tube is always located in the first operating handle during the pushing and retracting process.

[0040] The first operating handle is equipped with an operating component commonly used in the art to drive two coaxially arranged tubes to move relative to each other, and there are no special limitations in this utility model. The operating component is designed to be controlled by a knob. When the knob is turned in one direction, the inner tube is driven to retract towards the proximal end relative to the intermediate tube. When the knob is turned in the other direction, the inner tube is driven to push towards the distal end relative to the intermediate tube. For example, inside the first operating handle, a threaded drive component is provided between the inner tube and the outer tube. A nut with internal and external threads that can rotate in place is fixedly provided at the proximal end of the outer tube. A screw with external threads, coaxial with the inner tube, is fixedly connected at the proximal end of the inner tube. The screw is inserted into the nut and threadedly connected to the nut. A knob is provided on the first operating handle. The knob has external threads that engage with the external threads of the nut. When the knob is turned, the nut is driven to rotate, which in turn drives the screw to move linearly along the axis, thereby moving the inner tube.

[0041] The first operating handle is also equipped with an active device connected to the proximal end of the intermediate tube, which can drive the intermediate tube and the inner tube coaxial with the intermediate tube to rotate, thereby realizing automatic rotational cutting of thrombi.

[0042] Due to the application of the above technical solution, this utility model has the following advantages compared with the prior art:

[0043] The mechanical thrombectomy catheter device of this invention has a simple structure and is easy to operate. It can improve the cutting effect of thrombus in the radial direction while ensuring the cutting effect and safety of thrombus in the axial direction. Attached Figure Description

[0044] Figure 1 This is a schematic diagram of the overall structure of the mechanical thrombectomy catheter device in Example 1;

[0045] Figure 2 This is a three-dimensional structural schematic diagram of the cutting component of the mechanical thrombectomy catheter device of Example 1;

[0046] Figure 3 This is a partial structural diagram of the cutting component of the mechanical thrombectomy catheter device of Example 1 (the latter half is hidden);

[0047] Figure 4 This is a side view schematic diagram of the cutting component of the mechanical thrombectomy catheter device of Example 1;

[0048] Figure 5 This is a schematic diagram of the distal cross-sectional structure of the outer tube of the mechanical thrombectomy catheter device in Example 1.

[0049] The components are as follows: 1. Inner tube; 11. TIP head; 2. Intermediate tube; 3. Outer tube; 31. Fiber optic channel; 32. Pressure sensor; 4. Cutting component; 41. Outer support; 411. First rib; 412. Second rib; 413. Third rib; 414. Fourth rib; 415. Support unit; 42. Cutting unit; 43. Connector; 51. First operating handle; 511. Knob; 512. Active device; 52. Second operating handle; 521. FFR device; 6. Guide wire. Detailed Implementation

[0050] The present invention will be further described below with reference to the embodiments shown in the accompanying drawings.

[0051] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the present invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0052] In the description of this utility model, it should be understood that "distal end" refers to the end of the instrument or component away from the operator (e.g., medical personnel), and "proximal end" refers to the end of the instrument or component closer to the operator (e.g., medical personnel); "axial direction" refers to the direction parallel to the line connecting the centers of the distal and proximal ends of the instrument or component; "inner" and "outer" are positions defined by distance relative to the center of the instrument or component, where "inner" is the position closer to the center of the instrument or component, and "outer" is the position away from the center of the instrument or component. The above description of directional terms is only for the convenience of describing the embodiments of the present invention and simplifying the description, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the embodiments of the present invention.

[0053] In the description of this utility model, it should be understood that "crest" and "trough" are relative terms. "Crest" is the farthest position on the rib, and "trough" is the nearest position on the rib.

[0054] In the description of the embodiments of this utility model, it should be understood that the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the embodiments of this utility model, "multiple" means two or more, unless otherwise explicitly specified.

[0055] In this application, unless otherwise expressly specified and limited, the terms "connected," "fixed," etc., in the description of this utility model should be interpreted broadly, for example, meaning a fixed connection or an integral part. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of this invention according to the specific circumstances.

[0056] The following disclosure provides many different implementations or examples for different structures of the embodiments of the present invention. To simplify the disclosure of the embodiments of the present invention, specific examples of components and arrangements are described below. Of course, these are merely examples and are not intended to limit the embodiments of the present invention. Furthermore, reference numerals and / or reference letters may be repeated in different examples of the embodiments of the present invention; such repetition is for simplification and clarity and does not in itself indicate a relationship between the various implementations and / or arrangements discussed.

[0057] Example 1

[0058] like Figures 1-5As shown, this embodiment provides a mechanical thrombectomy catheter device, which includes a mechanical thrombectomy catheter assembly and an operating handle.

[0059] Specifically, the mechanical thrombectomy catheter assembly includes an inner tube 1, an intermediate tube 2, an outer tube 3, and a cutting component 4. The inner tube 1 has a guidewire lumen extending from one end to the other for the guidewire 6 to pass through. The intermediate tube 2 is movably fitted onto the inner tube 1 in a proximal-distal direction, with the distal end of the inner tube 1 extending beyond the distal end of the intermediate tube 2. The outer tube 3 is movably fitted onto the intermediate tube 2 in a proximal-distal direction, forming a channel between the intermediate tube 2 and the outer tube 3 for drug delivery or thrombus aspiration. The cutting component 4 is fitted onto the distal end of the inner tube 1, with its distal end fixedly connected to the inner tube 1 and its proximal end fixedly connected to the distal end of the intermediate tube 2. The cutting component 4 includes an outer stent 41, a cutting unit 42 located inside the outer stent 41, and a connector 43 for fixing the cutting unit 42 to the outer stent 41. The cutting unit 42 has a cutting opening, and its projection onto the inner tube 1 forms a closed-loop structure. The cutting component 4 has a radially contracted state and a radially expanded state. The cutting component 4 can switch between these states by adjusting the distance between the distal end of the inner tube 1 and the distal end of the intermediate tube 2. When the cutting component 4 is in the radially expanded state, the outer support 41 has a roughly spindle-shaped structure, and the cutting unit 42 is located in the middle of the spindle-shaped structure, with a distance between it and the inner tube 1. When the cutting component 4 is in the radially contracted state, the outer support 41 moves closer to the inner tube 1 and can be housed between the outer tube 3 and the inner tube 1.

[0060] In this embodiment, the axial length of the cutting component 4 in the radially expanded state is less than its axial length in the radially contracted state. The distal end of the inner tube 1 always extends beyond the distal end of the intermediate tube 2. When the cutting component 4 is in the radially contracted state, the length of the inner tube 1 extending beyond the distal end of the intermediate tube 2 is the longest, and when the cutting component 4 is in the radially expanded state, the length of the inner tube 1 extending beyond the distal end of the intermediate tube 2 is the shortest.

[0061] In this embodiment, the outer support 41 includes a first variable-diameter portion, a constant-diameter portion, and a second variable-diameter portion that are sequentially connected or integrally formed from its proximal end to its distal end. When the cutting component 4 is in a radially expanding state, the outer diameter of the first variable-diameter portion remains constant from the proximal end to the distal end, then gradually increases, and then remains constant again. The outer diameter of the second variable-diameter portion remains constant from the proximal end to the distal end, then gradually decreases, and then remains constant again. The outer diameter of the constant-diameter portion is equal to the distal outer diameter of the first variable-diameter portion, and equal to the proximal outer diameter of the second variable-diameter portion. The first variable-diameter portion includes multiple linear first ribs 411 arranged at intervals along the circumference of the inner tube 1. The second variable-diameter portion includes multiple linear second ribs 412 arranged at intervals along the circumference of the inner tube 1. The equal-diameter section has a ring-shaped structure with multiple deformable support units 415 connected sequentially along its circumference. Each support unit 415 has a through hole. When the cutting component 4 transitions from a radially contracted state to a radially expanded state, the length of the through hole gradually decreases in the direction parallel to the axis of the equal-diameter section and gradually increases in the circumferential direction of the equal-diameter section. The proximal end of the support unit 415 is fixedly connected to or integrally formed with the distal end of the first rib 411, and the distal end of the support unit 415 is fixedly connected to or integrally formed with the proximal end of the second rib 412. The support unit 415 can improve the contact between the cutting component 4 and the blood vessel wall, providing better support force, while being easily deformable, facilitating the transition of the cutting component 4 between the radially contracted and radially expanded states. In this embodiment, the equal-diameter portion includes a third rib 413 and a fourth rib 414, which are respectively wavy rings. The third rib 413 and the fourth rib 414 are symmetrically arranged and have staggered crests and troughs in the circumferential direction. The trough of the third rib 413 is fixedly connected to the distal end of the first rib 411 or integrally formed. The crest of the third rib 413 is fixedly connected to the trough of the fourth rib 414 or integrally formed to form the support unit 415. The crest of the fourth rib 414 is fixedly connected to the proximal end of the second rib 412 or integrally formed. The number of crests and troughs of the first rib 411, the second rib 412, the third rib 413, and the fourth rib 414 are all equal and connected in a one-to-one correspondence, thus eliminating the free ends of the first rib 411 and the second rib 412 and preventing damage to the blood vessel wall.

[0062] In this embodiment, the proximal end of the connector 43 is fixedly connected to the proximal end of the support unit 415, and the distal end of the connector 43 is fixedly connected to the proximal end of the cutting unit 42. When the cutting component 4 is in a radially expanded state, the connector 43 gradually tilts towards the inner tube 1 from its proximal end to its distal end at an angle of 20°. In this embodiment, the connector 43 has a length of 5 mm, a rhomboid cut, and an area of ​​16 mm². 2In this embodiment, only one of the two adjacent crests of the third rib 413 or the two adjacent first ribs 411 connects to the cutting unit 42. In this embodiment, when the cutting component 4 is in a radially expanded state, the area of ​​the support unit 415 is approximately six times the area of ​​the cutting opening.

[0063] In this embodiment, the axial length of the cutting component 4 in the radially contracted state is 3.5 cm, and the maximum outer diameter of the cutting component 4 in the radially expanded state is 2 cm. The material of the cutting component 4 is shape memory metal. The inner tube 1 and the intermediate tube 2 are both made of metal. The inner tube 1 is a rigid metal tube and its distal end is provided with a TIP head 11. The TIP head 11 includes a conical head. The outer diameter of the conical head decreases from the proximal end to the distal end. Preferably, the proximal outer diameter of the conical head is equal to the distal outer diameter of the outer tube 3.

[0064] In this embodiment, an optical fiber channel 31 is also provided in the wall of the outer tube 3, through which an optical fiber is threaded. A pressure sensor 32 is also provided at the distal end of the wall of the outer tube 3, and an FFR device 521 is also provided at the proximal end of the outer tube 3. The pressure sensor 32 is electrically connected to the FFR device 521 via an optical fiber. The pressure sensor 32 is used to monitor the pressure in real time and provide the information to the FFR device 521 for calculation and output of the fractional flow reserve (FFR). FFR can be used to indicate the blood supply status of blood vessels or the status of revascularization. To improve the sensitivity and accuracy of pressure detection, Pebax is selected as the material for the outer tube 3 in this embodiment.

[0065] Specifically, the operating handle includes a first operating handle 51 disposed at the proximal end of the inner tube 1 and the intermediate tube 2, and a second operating handle 52 disposed between the distal end of the outer tube 3 and the outer wall of the proximal end of the intermediate tube 2. The first operating handle 51 is used to control the movement of the inner tube 1 in the intermediate tube 2 and to lock the relative position of the inner tube 1 and the intermediate tube 2. The second operating handle 52 is used to control the movement of the outer tube 3 on the intermediate tube 2. The second operating handle 52 is provided with a first channel communicating with the liquid channel. The first channel can be connected to an external suction device or injection device through a hose.

[0066] In this embodiment, the mechanical thrombectomy catheter device also includes a guidewire 6. The second operating handle 52 is also provided with a second channel communicating with the optical fiber channel 31. The optical fiber passes through the second channel and is connected to the FFR device 521. The FFR device 521 can be fixedly installed on the second operating handle 52.

[0067] In this embodiment, a threaded drive component is provided inside the first operating handle 51 between the inner tube 1 and the outer tube 3. A nut with internal and external threads that can rotate in place is fixedly provided at the proximal end of the outer tube 3. A screw with external threads, coaxial with the inner tube 1, is fixedly connected to the proximal end of the inner tube 1. The screw is inserted into the nut and threadedly connected to the nut. A knob 511 is provided on the first operating handle 51. The knob 511 has external threads that engage with the external threads of the nut. When the knob 511 is turned, the nut is driven to rotate, which in turn drives the screw to move linearly along the axis, thereby moving the inner tube 1. The first operating handle 51 is also provided with an active device 512 connected to the proximal end of the intermediate tube 2, which can drive the intermediate tube 2 and the inner tube 1, which is coaxial with the intermediate tube 2, to rotate, thereby realizing automatic thrombus cutting.

[0068] The method of using the mechanical thrombectomy catheter device in this embodiment is as follows:

[0069] The cutting component 4 of the mechanical thrombectomy catheter device of this embodiment is delivered to the lesion site along the guidewire 6. The second operating handle 52 is controlled to retract the outer tube 3 proximally, exposing the cutting component 4. The first handle is controlled to retract the inner tube 1 proximally, and the cutting component 4 transitions from a radially contracted state to a radially expanded state. When the cutting component 4 is in the radially expanded state, pushing and pulling the first operating handle 51 in the proximal direction can simultaneously move the inner tube 1 and the intermediate tube 2, and the cutting component 4 cuts the thrombus axially. The intermediate tube 2 and the inner tube 1 are driven to rotate by the active device 512, and the cutting component 4 cuts the thrombus radially. Before and after cutting, medication can be delivered to the lesion site through the liquid channel. During cutting, fragmented thrombi can be aspirated by the aspiration device. After cutting, the first handle is controlled to push the inner tube 1 distally, and the cutting component 4 transitions from a radially expanded state to a radially contracted state. The first handle is controlled to push the inner tube 1 distally, and the cutting component 4 is stored in the outer tube 3. During use, blood flow can be monitored in real time through the FFR device 521.

[0070] The mechanical thrombectomy catheter device of this embodiment has a simple structure and is easy to operate. It can improve the cutting effect of thrombus in the radial direction while ensuring the cutting effect and safety of thrombus in the axial direction, thereby increasing the success rate of mechanical thrombectomy.

[0071] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.

Claims

1. A mechanical thrombectomy catheter device, comprising a mechanical thrombectomy catheter assembly, characterized in that, The mechanical thrombectomy catheter assembly includes: The inner tube (1) has a guide wire cavity extending from one end to the other for the guide wire (6) to pass through; The intermediate tube (2) is movably fitted onto the inner tube (1) in the proximal direction, with the distal end of the inner tube (1) extending beyond the distal end of the intermediate tube (2). The outer tube (3) is movably sleeved on the middle tube (2) in the proximal direction, and a liquid channel for delivering drugs or aspirating thrombi is formed between the middle tube (2) and the outer tube (3); A cutting component (4) is sleeved on the distal end of the inner tube (1) and its distal end is fixedly connected to the inner tube (1), and its proximal end is fixedly connected to the distal end of the intermediate tube (2). The cutting component (4) includes an outer support (41), a cutting unit (42) located inside the outer support (41), and a connector (43) for fixing the cutting unit (42) to the outer support (41). The cutting unit (42) has a cutting opening, and the projection of the cutting unit (42) on the inner tube (1) is a closed graphic structure. The cutting component (4) has a radially contracted state and a radially expanded state. By adjusting the distance between the distal end of the inner tube (1) and the distal end of the intermediate tube (2), the cutting component (4) can switch between the radially contracted state and the radially expanded state. When the cutting component (4) is in the radially expanded state, the outer support (41) is generally spindle-shaped, and the cutting unit (42) is located in the middle of the spindle-shaped structure and is a distance away from the inner tube (1). When the cutting component (4) is in the radially contracted state, the cutting component (4) moves closer to the inner tube (1) and can be stored in the outer tube (3).

2. The mechanical thrombectomy catheter device according to claim 1, characterized in that, The axial length of the cutting component (4) in the radially expanded state is less than its axial length in the radially contracted state.

3. The mechanical thrombectomy catheter device according to claim 1, characterized in that, The outer support (41) includes a first variable diameter portion, a constant diameter portion, and a second variable diameter portion that are sequentially connected or integrally formed from its proximal end to its distal end. When the cutting component (4) is in the radial expansion state, the outer diameter of the first variable diameter portion remains constant from the proximal end to the distal end, then gradually increases, and then remains constant again. The outer diameter of the second variable diameter portion remains constant from the proximal end to the distal end, then gradually decreases, and then remains constant again. The outer diameter of the equal diameter portion is equal to the distal outer diameter of the first variable diameter portion and equal to the proximal outer diameter of the second variable diameter portion.

4. The mechanical thrombectomy catheter device according to claim 3, characterized in that, The first variable diameter section includes multiple linear first ribs (411) arranged sequentially at intervals along the circumference of the inner tube (1). The second diameter-changing section includes multiple linear second ribs (412) arranged sequentially at intervals along the circumference of the inner tube (1). The equal-diameter portion has a ring structure with multiple deformable support units (415) connected in sequence along its circumference. Each support unit (415) has a through hole. When the cutting component (4) changes from the radial contraction state to the radial expansion state, the length of the through hole gradually decreases in the direction parallel to the axis of the equal-diameter portion and gradually increases in the circumferential direction of the equal-diameter portion. The proximal end of the support unit (415) is fixedly connected to the distal end of the first rib (411), and the distal end of the support unit (415) is fixedly connected to the proximal end of the second rib (412).

5. The mechanical thrombectomy catheter device according to claim 4, characterized in that, The equal-diameter portion includes a third rib (413) and a fourth rib (414) that are respectively wavy rings. The third rib (413) and the fourth rib (414) are arranged symmetrically to each other. The third rib (413) and the fourth rib (414) have staggered crests and troughs in the circumferential direction. The trough of the third rib (413) is fixedly connected to the distal end of the first rib (411). The crest of the third rib (413) is fixedly connected to the trough of the fourth rib (414) and forms the support unit (415). The crest of the fourth rib (414) is fixedly connected to the proximal end of the second rib (412). The number of crests and troughs of the first rib (411), the second rib (412), the third rib (413), and the fourth rib (414) are all equal and connected in a one-to-one correspondence.

6. The mechanical thrombectomy catheter device according to claim 1, characterized in that, The connector (43) has a linear structure. One end of it is fixedly connected to the outer support (41), and the other end is connected to the cutting unit (42). The connector (43) gradually moves away from the outer support (41) from the end connected to the outer support (41) to the other end and moves closer to the inner tube (1).

7. The mechanical thrombectomy catheter device according to claim 4, characterized in that, The proximal end of the connector (43) is fixedly connected to the proximal end of the support unit (415), and the distal end of the connector (43) is fixedly connected to the proximal end of the cutting unit (42). The connector (43) gradually tilts towards the inner tube (1) from its proximal end to its distal end. When the cutting component (4) is in a radially expanded state, the tilt angle is 10°-30°.

8. The mechanical thrombectomy catheter device according to claim 1, characterized in that, The outer tube (3) is also provided with an optical fiber channel (31) in the tube wall, and an optical fiber is inserted in the optical fiber channel (31). A pressure sensor (32) is also provided at the far end of the tube wall of the outer tube (3). The pressure sensor (32) is electrically connected to an FFR device (521) located near the near end of the outer tube (3) via an optical fiber.

9. The mechanical thrombectomy catheter device according to claim 1, characterized in that, The number of the cutting units (42) is one or more, and the multiple cutting units (42) are distributed at circumferential intervals along the cutting component (4); And / or, the area of ​​the cut is 4-16 mm². 2 ; And / or, the length of the connector (43) is 2-6 mm; And / or, the axial length of the cutting component (4) when it is in a radially contracted state is 1cm-5cm; And / or, the maximum outer diameter of the cutting component (4) when it is in a radially expanded state is 0.5cm-3cm; And / or, the inner tube (1) is a rigid metal tube; And / or, the intermediate tube (2) is made of polymer material or metal material.

10. A mechanical thrombectomy catheter device, characterized in that, The mechanical thrombectomy catheter device further includes a first operating handle (51) disposed at the proximal end of the inner tube (1) and the intermediate tube (2), and a second operating handle (52) disposed between the distal end of the outer tube (3) and the proximal outer wall of the intermediate tube (2). The first operating handle (51) is used to control the movement of the inner tube (1) in the intermediate tube (2) and to lock the relative position of the inner tube (1) and the intermediate tube (2). The second operating handle (52) is used to control the movement of the outer tube (3) on the intermediate tube (2). The second operating handle (52) is provided with a first channel communicating with the liquid channel. The first channel can be connected to an external aspiration device or injection device through a flexible tube. The mechanical thrombectomy catheter device also includes a guidewire (6).

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