Pulverizing bolt device

Abstract

This application provides a thrombus fragmentation device, including an aspiration catheter, an aspiration power device, and a thrombus fragmenter. The aspiration catheter has an inner lumen extending axially through both ends. The aspiration power device communicates with the inner lumen of the aspiration catheter and provides aspiration power to aspirate thrombus impurities from the blood vessel through the aspiration catheter, and its own volume accommodates the aspirated thrombus impurities. The thrombus fragmenter is movably inserted into the inner lumen of the aspiration catheter, and its distal end movably extends from the distal end of the aspiration catheter to push away or fragment thrombus impurities obstructing the distal end of the aspiration catheter. This thrombus fragmentation device can achieve highly efficient thrombus fragmentation.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a thrombus fragmentation device that can efficiently fragment thrombi. Background Technology

[0002] Embolism generally refers to the phenomenon where an abnormal substance insoluble in blood appears in the circulating blood and travels with the blood flow, eventually obstructing the lumen of a blood vessel. Embolism caused by a detached thrombus is called thromboembolism, which is the most common type of embolism. Currently, it is usually treated with thrombus aspiration devices, for example, cutting and fragmenting the thrombus and then removing it from the body through a vacuum device. To ensure aspiration efficiency and surgical success rate, it is essential to ensure that the device does not become blocked during the aspiration process.

[0003] Existing thrombus aspiration devices typically include an aspiration catheter and a connected vacuum pump. The aspiration catheter comprises a tube body, a protective shell outside the tube body, and a cutting blade inside the protective shell. Because the cutting blade is located inside the protective shell, it is generally a certain distance from the aspiration port at the distal end of the aspiration catheter and cannot move. Therefore, when using this type of aspiration device to treat thromboembolism, during the aspiration process, if a relatively solidified and hardened thrombus blocks the aspiration port of the aspiration catheter, it is difficult to remove the thrombus blocking the aspiration port because the aspiration port can only continuously aspirate radially, and the cutting blade cannot move. This leads to the thrombus gradually accumulating, tightly covering and enveloping the aspiration port, or even completely blocking it. The thrombus may also directly jam the cutting blade, rendering the device unusable. This not only affects the aspiration speed and efficiency of the aspiration device but also seriously impacts the treatment effect on embolism and may even pose a life-threatening risk to the patient. Summary of the Invention

[0004] The purpose of this application is to provide a thrombus breaking device that can efficiently break thrombi.

[0005] To achieve the above objectives, the thrombus fragmentation device provided in this application includes an aspiration catheter, an aspiration power device, and a thrombus fragmenter. The aspiration catheter has an inner lumen extending axially through both ends. The aspiration power device communicates with the inner lumen of the aspiration catheter and provides aspiration power to draw out thrombus impurities from the blood vessel through the aspiration catheter, and its own volume accommodates the drawn-out thrombus impurities. The thrombus fragmenter is movably inserted into the inner lumen of the aspiration catheter, and its distal end movably extends from the distal end of the aspiration catheter to push away or fragment thrombus impurities obstructing the distal end of the aspiration catheter.

[0006] In the thrombus fragmentation device provided in this application, since the thrombus fragmenter is movably inserted into the inner lumen of the aspiration catheter, when thrombus impurities block the distal end of the aspiration catheter, the operator can control the thrombus fragmenter to move and / or rotate axially within the inner lumen of the aspiration catheter. The distal end of the thrombus fragmenter can extend beyond the distal end of the aspiration catheter, thereby pushing away or crushing the thrombus impurities blocking the distal end of the aspiration catheter. This can prevent thrombus impurities from blocking the aspiration port of the aspiration catheter and achieve efficient thrombus fragmentation. Attached Figure Description

[0007] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0008] Figure 1 This is a schematic diagram of the overall structure of the bolt breaking device provided in one embodiment of this application.

[0009] Figure 2 yes Figure 1 A schematic diagram showing the working state of the distal end of the thrombectomy device after it extends from the distal end of the aspiration catheter.

[0010] Figure 3 yes Figure 2 An enlarged schematic diagram of part III in the diagram.

[0011] Figure 4 yes Figure 2 A cross-sectional view of the connecting pipe in the middle.

[0012] Figure 5 yes Figure 4 A partial cross-sectional view of the connecting tube through which the suction catheter and the broken embolus rod are inserted.

[0013] Figure 6 yes Figure 2 A schematic diagram of the thrombus breaker in the image.

[0014] Figure 7 This is a schematic diagram of the structure of a thrombus breaker provided in another embodiment of this application.

[0015] Figure 8 yes Figure 7 A schematic diagram showing the working state of the distal end of the thrombectomy device after it extends from the distal end of the aspiration catheter.

[0016] Figure 9 This is a schematic diagram of the structure of a thrombus breaker provided in another embodiment of this application.

[0017] Figure 10 yes Figure 9An enlarged diagram of the X part in the figure.

[0018] Figure 11 yes Figure 9 A schematic diagram showing the working state of the distal end of the thrombectomy device after it extends from the distal end of the aspiration catheter.

[0019] Figure 12 This is a connection diagram of the first control mechanism, the bolt breaking rod, and the bolt breaking mechanism provided in one embodiment of this application.

[0020] Figure 13 This is a three-dimensional structural diagram of the bolt breaking mechanism provided in one embodiment of this application.

[0021] Figure 14 This is a three-dimensional structural schematic diagram of a bolt-breaking mechanism provided in another embodiment of this application.

[0022] Explanation of main component symbols

[0023] Bolt breaking device 1

[0024] 20 suction catheters

[0025] Gap 21

[0026] Suction power unit 40

[0027] Pump body 41

[0028] Tube body 43

[0029] 60 thrombus breaker

[0030] Connecting pipe 80

[0031] First inner cavity 81

[0032] Second inner cavity 82

[0033] Supervisory body 83

[0034] Deputy tube body 84

[0035] Stop structure 85

[0036] Seal 86

[0037] Broken bolt rod 61

[0038] Pre-bending shaping section 612

[0039] Adjustable bend 614

[0040] Anchoring ring 91

[0041] traction wire 92

[0042] Bolt breaking mechanism 63

[0043] Fan blade 632

[0044] Protective Case 634

[0045] Operating handle 65

[0046] First control unit 651

[0047] Adjustment wheel 6512

[0048] Base plate 6514

[0049] First ring 6341

[0050] Second ring 6342

[0051] The following detailed description, in conjunction with the accompanying drawings, will further illustrate this application. Detailed Implementation

[0052] 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 them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0053] Furthermore, the following descriptions of various embodiments are based on the accompanying illustrations and are used to illustrate specific embodiments that can be implemented in this application. Directional terms used in this application, such as "up," "down," "front," "back," "left," "right," "inner," "outer," and "side," are merely for reference to the accompanying illustrations. Therefore, the directional terms used are for better and clearer explanation and understanding of this application, and are 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. Therefore, they should not be construed as limitations on this application.

[0054] It should be noted that, in order to more clearly describe the structure of the thrombectomy device provided in this application, the limiting terms "proximal" and "distal" used in the specification are conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end away from the operator during the surgical procedure, and "proximal" refers to the end closer to the operator during the surgical procedure; the direction of the rotational axis of an object such as a cylinder or tube is defined as the axial direction; the circumferential direction is the direction around the axis of the object such as a cylinder or tube; and the radial direction is the direction along the diameter or radius.

[0055] It is worth noting that the term "end" appearing in terms such as "proximal end," "distal end," "one end," "the other end," "first end," "second end," "initial end," "end," "both ends," "head end," "upper end," and "lower end" is not limited to a head, end point, or end face, but also includes a portion extending axially and / or radially from the head, end point, or end face on the element to which the head, end point, or end face belongs. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The conventional terminology used in this application's specification is for the purpose of describing particular embodiments only and should not be construed as limiting this application.

[0056] Please combine Figures 1 to 3 This application provides a thrombus fragmentation device 1 for aspirating thrombus impurities 3 within a blood vessel 2. Specifically, the thrombus fragmentation device 1 includes an aspiration catheter 20, a suction power device 40, and a thrombus fragmenter 60. The aspiration catheter 20 has an inner lumen extending axially through both ends, with the distal end of the aspiration catheter 20 inserted into the blood vessel 2 and close to the thrombus impurities 3 within the blood vessel 2. The suction power device 40 communicates with the inner lumen of the aspiration catheter 20 and provides suction power to aspirate the thrombus impurities 3 from the blood vessel 2 through the aspiration catheter 20, and its own volume accommodates the aspirated thrombus impurities 3. The thrombus fragmenter 60 is movably inserted into the inner lumen of the aspiration catheter 20, and its distal end movably extends beyond the distal end of the aspiration catheter 20 to push away or fragment the thrombus impurities 3 blocking the distal end of the aspiration catheter 20.

[0057] The aspiration catheter 20 can be a medical hollow tube as used in the prior art, and its inner lumen size allows the thrombectomy device 60 to move freely back and forth within it. The aspiration power device 40 can be, but is not limited to, a suction pump that uses vacuum negative pressure to provide aspiration power. Its specific structure and working principle are basically the same as those of suction pumps in the prior art, and will not be described in detail here.

[0058] In the thrombus fragmentation device 1 provided in this application, the thrombus fragmenter 60 is movably inserted into the inner lumen of the aspiration catheter 20. When using the thrombus fragmentation device 1 to aspirate thrombus impurities 3 in the blood vessel 2, if the thrombus impurities 3 block the distal end of the aspiration catheter 20, the operator can manually control the thrombus fragmenter 60 to move and / or rotate axially within the inner lumen of the aspiration catheter 20, thereby extending the distal end of the thrombus fragmenter 60 beyond the distal end of the aspiration catheter 20. This pushes away or crushes the thrombus impurities 3 blocking the distal end of the aspiration catheter 20, preventing the thrombus impurities 3 from blocking the aspiration port at the distal end of the aspiration catheter 20, thus achieving efficient thrombus fragmentation. Furthermore, after the thrombus impurities 3 in the blood vessel 2 are crushed by the thrombus fragmenter 60, the size of the thrombus impurities 3 is smaller, and the aspiration power device 40 can provide a smaller aspiration power to aspirate the thrombus impurities 3. Moreover, the crushed thrombus impurities 3 can be more easily discharged through the inner lumen of the aspiration catheter 20, improving the aspiration speed and efficiency of the thrombus impurities 3. In addition, the thrombus fragmentation device 1 can be operated manually throughout its use, which is convenient and safe, and can better protect the inner wall of the blood vessel 2.

[0059] Among them, such as Figure 1 and Figure 2 As shown, in some embodiments, the suction power device 40 may include a pump body 41 and a tube 43 connected at one end to the pump body 41. The other end of the tube 43 is used to connect to the inner lumen of the suction catheter 20. The pump body 41 is used to contain the aspirated thrombus impurities 3. The tube 43 is preferably made of a flexible material and has a certain length, so that the pump body 41 can be fixedly placed. The operator only needs to hold the other parts of the thrombus fragmentation device 1 except for the pump body 41, which reduces the operator's carrying burden and makes the operation more flexible.

[0060] Preferably, such as Figure 1 and Figure 2 As shown, in some embodiments, the thrombectomy device 1 further includes a connecting tube 80, the proximal end of the suction catheter 20 is fixed in the connecting tube 80, the suction power device 40 is connected to the inner lumen of the suction catheter 20 through the connecting tube 80, and the thrombectomy device 60 is movably inserted from the proximal end of the connecting tube 80 into the inner lumen of the connecting tube 80 and the inner lumen of the suction catheter 20. It is understood that after the suction catheter 20, the suction power device 40, and the thrombectomy device 60 are connected together through the connecting tube 80, the connecting tube 80 can be held by one hand by the operator, while the operator's other hand holds the proximal end of the thrombectomy device 60 to control the movement of the thrombectomy device 60 within the inner lumen of the suction catheter 20.

[0061] Specifically, please combine Figure 4 and Figure 5In some embodiments, the connecting tube 80 has a first inner cavity 81 extending axially through both ends and a second inner cavity 82 communicating with the first inner cavity 81. The proximal end of the suction catheter 20 is inserted into the first inner cavity 81, and the inner cavity of the suction catheter 20 is connected to both the first inner cavity 81 and the second inner cavity 82. The suction power device 40 is connected to the inner cavity of the suction catheter 20 via the second inner cavity 82. The thrombectomy device 60 (specifically its thrombectomy rod 61) is movably inserted from the proximal end of the first inner cavity 81 into both the first inner cavity 81 and the inner cavity of the suction catheter 20.

[0062] exist Figure 4 and Figure 5 In the example, the connecting tube 80 is a double-lumen tube, comprising a main tube 83 extending axially along the suction catheter 20 and a secondary tube 84 connected to one side of the main tube 83. The main tube 83 has a first inner lumen 81, and the secondary tube 84 has a second inner lumen 82. Figure 2 As shown, the end of the tube 43 of the suction power device 40 away from the pump body 41 is sealed and connected to the end of the auxiliary tube 84 away from the main tube 83, so that the inner cavity of the tube 43 is connected to the second inner cavity 82, thereby allowing the pump body 41 to be connected to the inner cavity of the suction conduit 20 through the inner cavity of the tube 43 and the second inner cavity 82. Figure 5 As shown, the proximal end of the aspiration catheter 20 is inserted into the first inner lumen 81 from the distal end of the main tube 83, and the inner lumen of the aspiration catheter 20 is connected to the first inner lumen 81. The thrombectomy device 60 is movably inserted from the proximal end of the main tube 83 into the first inner lumen 81 and the inner lumen of the aspiration catheter 20.

[0063] The end of the tube 43 furthest from the pump body 41 can be fixedly connected to or detachably connected to the end of the auxiliary tube 84 furthest from the main tube 83, preferably detachably connected. In this way, after the tube 43 is disconnected from the auxiliary tube 84, the end of the auxiliary tube 84 furthest from the main tube 83 can be connected to a drug injector to inject drugs (such as drugs that soften thrombus impurities 3) into the blood vessel 2.

[0064] The inner diameter of the first inner cavity 81 is adapted to the outer diameter of the suction catheter 20. The inner diameter of the first inner cavity 81 can be equal to or slightly larger than the outer diameter of the suction catheter 20. As long as the proximal end of the suction catheter 20 can be inserted into the first inner cavity 81 and fixed to the main body 83 by any means such as glue connection, threaded connection or interference fit, there is no limitation on this.

[0065] like Figure 5 As shown, the outer wall of the suction catheter 20 near its proximal end has a notch 21 that connects to its inner cavity. When the suction catheter 20 is inserted into the first inner cavity 81, the notch 21 connects to the second inner cavity 82, thereby allowing the inner cavity of the suction catheter 20 to connect to the pump body 41 via the connected second inner cavity 82 and the inner cavity of the tube body 43 (see...). Figure 2Thus, under the suction power provided by the suction power device 40, the thrombus impurities 3 (see...) Figure 3 It can be aspirated and sequentially enter the pump body 41 through the gap 21 between the inner wall of the aspiration conduit 20 and the outer wall of the thrombus breaker 60 (specifically the thrombus breaker rod 61), the second inner cavity 82, and the inner cavity of the tube body 43.

[0066] Optionally, the secondary tube 84 can extend proximally in a direction away from the main tube 83 or distally in a direction away from the main tube 83, making the connecting tube 80 approximately "Y"-shaped. Alternatively, the secondary tube 84 can extend in a direction perpendicular to the main tube 83, making the connecting tube 80 approximately "T"-shaped. Preferably, in... Figure 4 and Figure 5 In the example, the secondary tube 84 extends proximally away from the main tube 83, and the extension direction of the second inner lumen 82 follows the flow direction of the aspirated thrombus impurities 3 in the gap between the inner wall of the aspiration catheter 20 and the outer wall of the thrombus fragmenter 60. The inner wall of the second inner lumen 82 has a small obstruction effect on the thrombus impurities 3, which facilitates the smooth flow of the thrombus impurities 3 into the second inner lumen 82 and further into the pump body 41 through the second inner lumen 82 and the inner lumen of the tube 43.

[0067] In addition, optionally, in Figure 4 and Figure 5 In the example, the inner diameter of the second inner cavity 82 gradually decreases from the end connected to the tube body 43 to the end connected to the first inner cavity 81. In other words, the inner diameter of the second inner cavity 82 gradually decreases along the direction of suction power transmission. It can be understood that, with the gap 21 between the inner wall of the suction catheter 20 and the outer wall of the thrombus fragmenter 60, and the individual dimensions of the inner cavity of the tube body 43 remaining unchanged, setting the inner diameter of the second inner cavity 82 to gradually decrease along the direction of suction power transmission is beneficial to enhancing the suction effect generated by the suction power provided by the suction power device 40 at the suction port at the distal end of the suction catheter 20, thereby improving the suction speed and efficiency of the thrombus impurities 3. Conversely, when the aspirated thrombus impurities 3 flow into the pump body 41 through the second inner cavity 82 and the tube body 43, the gradual increase in the inner diameter of the second inner cavity 82 in its flow direction can reduce the impact of the thrombus impurities 3 on the tube body 43, making it easier for the thrombus impurities 3 to enter the pump body 41. Of course, in other examples, the inner diameter of the second inner cavity 82 may remain unchanged, and there is no limitation on this.

[0068] Preferably, in Figure 4 and Figure 5In the example, the inner wall of the first inner cavity 81 is provided with a stop structure 85. The connection between the first inner cavity 81 and the second inner cavity 82 and the proximal end of the first inner cavity 81 are located on both sides of the stop structure 85. When the proximal end of the suction catheter 20 is inserted into the first inner cavity 81, the proximal end of the suction catheter 20 abuts against the stop structure 85, and the notch 21 corresponds to the connection between the first inner cavity 81 and the second inner cavity 82, so that the second inner cavity 82 is connected to the inner cavity of the suction catheter 20. By setting a stop structure 85 in the first inner cavity 81, the suction catheter 20 can be limited and positioned. The operator only needs to insert the proximal end of the suction catheter 20 into the first inner cavity 81 until the proximal end of the suction catheter 20 hits the stop structure 85, which will ensure that the notch 21 of the suction catheter 20 is connected to the second inner cavity 82, thereby connecting the second inner cavity 82 with the inner cavity of the suction catheter 20. The operator does not need to deliberately control the length of the suction catheter 20 inserted into the first inner cavity 81, making the operation simple and convenient.

[0069] The stop structure 85 can be, but is not limited to, a stop ring or a stop block disposed on the inner wall of the first inner cavity 81. Figure 4 and Figure 5 In the example, the stop structure 85 is the stop ring.

[0070] Furthermore, in Figure 4 and Figure 5 In the example, a seal 86 is provided at the proximal end of the first inner cavity 81, and the seal 86 has an inner hole. For example... Figure 5 As shown, when the thrombectomy device 60 is movably inserted into the cavity of the communicating first inner cavity 81 and the aspiration catheter 20, the thrombectomy device 60 passes through the inner hole of the seal 86 and engages with the seal 86. The seal 86 is used to seal the proximal port of the first inner cavity 81, thereby preventing blood or medication from leaking from the proximal port of the first inner cavity 81 during the aspiration of thrombus impurities 3 by the aspiration power device 40 or the injection of medication by the drug injector.

[0071] Optionally, the seal 86 can be fixedly disposed on the proximal inner wall of the first inner cavity 81 near its proximal port, or it can be fixedly disposed at the proximal end of the first inner cavity 81. Figure 4 and Figure 5 In the example, the seal 86 is fixedly disposed on the proximal inner wall of the first inner cavity 81 near its proximal port.

[0072] The sealing element 86 may be, but is not limited to, an adjustable sealing valve, an elastic sealing ring, etc., and may be fixedly connected to the connecting pipe 80 by any reasonable means such as bonding or welding, without limitation.

[0073] Please combine Figure 1 , Figure 3 , Figure 5 as well as Figure 6 In some embodiments, the thrombectomy device 60 includes a thrombectomy rod 61, which is movably inserted into the lumen of the communicating first inner lumen 81 and the aspiration catheter 20. After the distal end of the thrombectomy rod 61 extends from the distal end of the aspiration catheter 20, the thrombectomy rod 61 moves and / or rotates axially to push away or crush thrombus impurities 3 blocking the distal end of the aspiration catheter 20, thereby preventing thrombus impurities 3 from blocking the aspiration port at the distal end of the aspiration catheter 20. To accommodate blood vessels 2 of different lengths and / or inner diameters, the length of the thrombectomy rod 61 ranges from 40 cm to 200 cm, and the outer diameter of the thrombectomy rod 61 ranges from 3 mm to 7 mm.

[0074] Among them, the break-bolt rod 61 has a guide wire cavity extending along its axial direction (see...). Figure 5 The guidewire lumen is used for inserting the guidewire. After the thrombus fragment 61 is inserted into the lumen of the first lumen 81 and the aspiration catheter 20, the fragment 61, along with the distal end of the aspiration catheter 20, can be delivered along the guidewire to the vicinity of the thrombus impurity 3 in the blood vessel 2. Then, using the aspiration power provided by the aspiration power device 40, the thrombus impurity 3 can be aspirated through the aspiration catheter 20. Figure 3 As shown, when the thrombus impurity 3 blocks the suction port at the distal end of the suction catheter 20, the thrombus fragment rod 61 can be controlled to move and / or rotate along the axial direction to push the thrombus impurity 3 away from the suction port or to crush it, thereby solving the problem of the thrombus impurity 3 blocking the suction port.

[0075] The embolus fragment 61 is preferably made of a material with wear resistance and self-lubricating properties (such as, but not limited to, nylon), which facilitates the smooth movement of the embolus fragment 61 in the blood vessel 2.

[0076] Furthermore, such as Figure 1 and Figure 6 As shown, in some embodiments, the thrombus fragmenter 60 also includes an operating handle 65 connected to the proximal end of the thrombus fragmenting rod 61. The operator controls the axial movement and / or rotation of the thrombus fragmenting rod 61 by holding the operating handle 65, thereby pushing away or crushing the thrombus impurities 3 blocking the distal end of the aspiration catheter 20.

[0077] Preferably, in Figure 1 and Figure 6 In the example, the operating handle 65 is provided with an anti-slip structure to prevent the operator's hand from slipping when gripping the operating handle 65. The anti-slip structure can be a protrusion and / or groove provided on the surface of the operating handle 65, or it can be an anti-slip material covering the surface of the operating handle 65 (such as, but not limited to, an anti-slip coating or an anti-slip film). The specific structural form and number of the anti-slip structure are not limited, as long as it has the anti-slip function.

[0078] Please combine Figure 7 and Figure 8In some embodiments, the distal end of the thrombus fragment 61 has a pre-bent shaping section 612, allowing the distal end of the thrombus fragment 61 to bend after extending from the distal end of the aspiration catheter 20. Thus, the thrombus fragmentation device 1 can be used to aspirate and remove thrombus impurities 3 from the bends in the blood vessel 2. The pre-bent shaping section 612 can be made of a flexible medical material, such as, but not limited to, polyetheramide. It should be noted that when the distal end of the thrombus fragment 61 is housed within the lumen of the aspiration catheter 20, the pre-bent shaping section 612 deforms and becomes approximately straight under the constraint of the inner wall of the aspiration catheter 20. As the distal end of the thrombus fragment 61 gradually extends from the distal end of the aspiration catheter 20, the pre-bent shaping section 612 gradually recovers its deformation and becomes bent, thereby adapting to the bends in the blood vessel 2.

[0079] The bending angle of the pre-bending shaping segment 612 can be set according to the degree of bending of the vessel 2 where the thrombus impurity 3 is located. The degree of bending of the vessel 2 can be obtained by existing technologies such as ultrasound and digital subtraction angiography (DSA), which will not be elaborated here.

[0080] Understandably, when thrombus impurities 3 are present at a bend in the vessel 2, controlling the reciprocating movement and / or rotation of the distally straight thrombus fragmentation rod 61 via the operating handle 65 will not be able to push away or crush the thrombus impurities 3, and may even damage the inner wall of the vessel 2. Conversely, by providing a pre-bent shaping section 612 at the distal end of the thrombus fragmentation rod 61, as the distal end of the thrombus fragmentation rod 61 gradually extends out of the distal end of the aspiration catheter 20, the pre-bent shaping section 612 gradually bends and adapts to the bend in the vessel 2. When the distal end of the thrombus fragmentation rod 61 gradually retracts into the distal end of the aspiration catheter 20, the pre-bent shaping section 612 deforms and gradually straightens and retracts into the aspiration catheter 20. Therefore, controlling the axial reciprocating movement of the thrombus fragmentation rod 61 with the pre-bent shaping section 612 via the operating handle 65 can push away or crush the thrombus impurities 3, solving the problem of thrombus impurities 3 blocking the aspiration port of the aspiration catheter 20, without damaging the inner wall of the bend in the vessel 2. When the pre-bent shaping section 612 is housed in the lumen of the aspiration catheter 20, the operator can also control the rotation of the thrombectomy rod 61 by operating the handle 65 to adjust the bending direction of the pre-bent shaping section 612, so that the pre-bent shaping section 612 can be accurately bent into the bend of the blood vessel 2 after extending from the distal end of the aspiration catheter 20.

[0081] Understandably, after the pre-bent shaping segment 612 extends to the distal end of the aspiration catheter 20, the operator cannot control the rotation of the thrombectomy rod 61 through the operating handle 65 to avoid the pre-bent shaping segment 612 swinging and damaging the inner wall of the blood vessel 2.

[0082] Please combine Figures 9 to 11In other embodiments, the distal end of the thrombectomy rod 61 has at least one adjustable bend 614, and the thrombectomy device 60 further includes at least one set of bending adjustment components. These components are used to adjust the bending of the corresponding adjustable bend 614 after the distal end of the thrombectomy rod 61 extends from the distal end of the aspiration catheter 20. It is understood that when the thrombectomy rod 61 is provided with multiple adjustable bends 614 and correspondingly with multiple sets of bending adjustment components, the thrombectomy rod 61 can be bent in multiple directions.

[0083] Specifically, in Figures 9 to 11 In the example, the bending assembly includes an anchoring ring 91 fixedly disposed at the distal end of the broken bolt rod 61, and at least one traction wire 92 movably inserted into the broken bolt rod 61. One end of the traction wire 92 is fixedly connected to the anchoring ring 91, and the other end extends from the proximal end of the broken bolt rod 61. By pulling the traction wire 92 toward the proximal end, the adjustable bending section 614 connected to the anchoring ring 91 can be bent in the traction direction. When the traction wire 92 is released, the adjustable bending section 614 can return to a straight shape.

[0084] The adjustable bending section 614 can be made of a medical material with good flexibility, such as, but not limited to, polyetheramide; the specific structure and bending principle of the anchoring ring 91 and the traction wire 92 are the same as those of the anchoring ring and the traction wire in the prior art, and will not be described in detail here.

[0085] Preferably, such as Figure 9 As shown, in some embodiments, the proximal end of the bending assembly (i.e., the proximal end of the traction wire 92) is connected to a first control mechanism 651 on the operating handle 65. The first control mechanism 651 is used to control the movement of the bending assembly (i.e., pulling or releasing the traction wire 92) to adjust the bending angle of the adjustable bending section 614. For details, please refer to... Figure 12 In one feasible implementation, the first control mechanism 651 includes an adjusting wheel 6512 rotatably sleeved on the proximal end of the bolt-breaking rod 61, and the proximal end of the traction wire 92 is fixedly connected to the adjusting wheel 6512. When the adjusting wheel 6512 rotates clockwise around the bolt-breaking rod 61, the adjusting wheel 6512 winds the proximal portion of the traction wire 92, thereby pulling the traction wire 92 towards the proximal end to drive the corresponding adjustable bending section 614 to bend; when the adjusting wheel 6512 rotates counterclockwise around the bolt-breaking rod 61, the adjusting wheel 6512 can release the wound traction wire 92, thereby allowing the corresponding adjustable bending section 614 to restore its deformation.

[0086] More preferably, such as Figure 12As shown, in one feasible embodiment, the first control mechanism 651 further includes an angle reference disk 6514 fixedly disposed near the end of the bolt rod 61. The angle reference disk 6514 is provided with a plurality of angle marks around its circumference for reference display of the adjustment angle. The operator can quantitatively adjust the bending angle of the adjustable bending section 614 by referring to the plurality of angle marks on the angle reference disk 6514, which makes it more convenient for the operator to operate.

[0087] The adjusting wheel 6512 and the angle reference plate 6514 can be spaced apart along the axial direction of the bolt rod 61. The adjusting wheel 6512 can be located on the side of the angle reference plate 6514 away from the adjustable bending section 614, or it can be located on the side of the angle reference plate 6514 close to the adjustable bending section 614. There is no limitation on this.

[0088] It is understandable that by providing at least one adjustable bend 614 at the distal end of the bolt breaker 61, and by providing at least one set of bend adjustment components correspondingly to the bolt breaker 60, such as... Figure 11 As shown, when the thrombus impurity 3 is present at the bend in the blood vessel 2, the thrombus fragmentation rod 61 is moved back and forth by operating the handle 65, and the bending adjustment component is controlled by the first control mechanism 651 to drive the corresponding adjustable bending section 614 to bend, which can push away or crush the thrombus impurity 3, thereby solving the problem of the thrombus impurity 3 blocking the suction port of the suction catheter 20, and without damaging the inner wall of the bend in the blood vessel 2. Furthermore, compared to the pre-bent shaping section 612 in some embodiments, when the adjustable bending section 614 is bent under the drive of its corresponding connected bending component, the operator can quantitatively adjust the bending angle of the adjustable bending section 614 through the cooperation of the adjusting wheel 6512 and the angle reference plate 6514, so that the distal end of the thrombus fragmentation rod 61 can be bent to different angles. Therefore, the thrombus fragmentation device 1, which has at least one adjustable bending section 614 at the distal end, can be used to aspirate thrombus impurities 3 in blood vessels 2 with different degrees of curvature. In addition, when the adjustable bending section 614 is not bent, the thrombus fragmentation device 1 can also be used to aspirate thrombus impurities 3 in straight blood vessels 2, thus having a wider range of applications.

[0089] Please combine Figure 3 , Figures 6 to 11 In some embodiments, the thrombectomy device 60 further includes a thrombectomy mechanism 63 disposed at the distal end of the thrombectomy rod 61. The thrombectomy mechanism 63 is used to provide shearing force to break up the thrombus impurities 3 blocking the distal end of the aspiration catheter 20. By providing the thrombectomy mechanism 63 at the distal end of the thrombectomy rod 61, when the distal end of the aspiration catheter 20 encounters a hard, coagulated thrombus impurity 3, the axial reciprocating movement and / or rotation of the thrombectomy rod 61 may not be able to break up the coagulated thrombus impurity 3. The shearing force provided by the thrombectomy mechanism 63 can break up the coagulated thrombus impurity 3, thereby solving the problem of thrombus impurities 3 blocking the aspiration port of the aspiration catheter 20.

[0090] Please combine Figure 13 and Figure 14 In some embodiments, the thrombus fragmentation mechanism 63 can be a turbine structure, which includes at least one rotatable blade 632 and a protective shell 634 fixedly connected to each blade 632 and surrounding the periphery of the blade 632. The blade 632 rotates at a high speed, which can be used to shear and break up thrombus impurities 3, so that the thrombus impurities 3 will not block the suction port of the suction catheter 20. The protective shell 634 is used to prevent damage to the inner wall of the blood vessel 2 when the blade 632 rotates, making the entire thrombus fragmentation device 1 safer.

[0091] In particular, the blade surface of each blade 632 is preferably set parallel to the central axis of the suction conduit 20. In this way, when it is not necessary to break up the plug, it is beneficial to enlarge the suction port of the suction conduit 20, increase the suction speed, and improve the plug removal efficiency.

[0092] Understandably, when the inner diameter of blood vessel 2 is small, the thrombus fragmentation mechanism 63 should not be too large. Therefore, the number of fan blades 632 should not be too many, for example, it can be set to three. When the inner diameter of blood vessel 2 is large, four, five or more fan blades 632 can be set to improve the thrombus fragmentation efficiency. Among them, the number of fan blades 632 is preferably three. It should be noted that the guide wire cavity of the thrombus fragmentation rod 61 passes through the connection part of multiple fan blades 632, and the fan blades 632 can be connected to the operating handle 65 via a transmission component. The fan blades 632 can be rotated by the operating handle 65 to break up thrombus impurities 3.

[0093] The fan blade 632 and the protective shell 634 are fixedly connected, for example, by laser welding. Both the fan blade 632 and the protective shell 634 can be made of medical-grade metal materials (e.g., but not limited to stainless steel) or polymer materials (e.g., but not limited to polyethylene, polyetheramide). Preferably, the fan blade 632 is made of metal and the protective shell 634 is made of polymer material. The hardness of the fan blade 632 is greater than that of the protective shell 634. This combination can both fragment the thrombus and protect the inner wall of the blood vessel 2.

[0094] Optionally, such as Figure 13 As shown, in one feasible embodiment, the protective shell 634 is a cylindrical protective shell that surrounds the outer periphery of the multi-lobed fan blade 632, and the inner peripheral wall of the protective shell 634 is connected to the outer edge of each fan blade 632 along the radial direction of the embolus rod 61, thereby protecting the inner wall of the blood vessel 2.

[0095] Optionally, such as Figure 14As shown, in another feasible embodiment, the protective shell 634 includes a first ring body 6341 and a second ring body 6342. The first ring body 6341 and the second ring body 6342 are spaced apart along the axial direction of the embolus fragment rod 61 and are respectively fixedly connected to the proximal and distal ends of the outer edge of each blade 632. Thus, the first ring body 6341 and the second ring body 6342, which are spaced apart along the axial direction of the embolus fragment rod 61, surround the outer periphery of the multi-bladed blade 632, thereby protecting the inner wall of the blood vessel 2. The first ring body 6341 can be located on the side of the second ring body 6342 away from the distal end of the embolus fragment rod 61, or it can be located on the side of the second ring body 6342 closer to the distal end of the embolus fragment rod 61; there is no limitation on this.

[0096] Preferably, in Figure 14 In the example, the protective shell 634 is also connected to a second control mechanism (not shown) on the operating handle 65. The second control mechanism is used to control the movement of the protective shell 634 to adjust the yaw angle of the blade surface of each blade 632. Specifically, the second control mechanism is connected to at least one of the first ring body 6341 and the second ring body 6342 to drive the first ring body 6341 and the second ring body 6342 to reverse relative to each other, thereby causing the yaw angle of the blade surface of each blade 632 to gradually increase. In one feasible implementation, the second control mechanism may include a first adjusting ring and a second adjusting ring that are sleeved on the proximal end of the break bar 61. The first adjusting ring and the second adjusting ring are respectively connected to the first ring body 6341 and the second ring body 6342. By controlling the first adjusting ring and the second adjusting ring to rotate in opposite directions, the first ring body 6341 and the second ring body 6342 are driven to rotate in opposite directions, thereby causing the blade surface of each blade 632 to twist and wobble. As the first adjusting ring and the second adjusting ring continue to rotate in opposite directions, the wobble angle of the blade surface of each blade 632 gradually increases, and the adjustment range of the wobble angle is between 0 degrees and 90 degrees.

[0097] As mentioned earlier, when thrombectomy is not required, the blade surface of each blade 632 is parallel to the central axis of the aspiration catheter 20. When thrombectomy is required, the first ring 6341 and the second ring 6342 can be rotated in opposite directions by the second control mechanism on the operating handle 65, so that the blade surface of each blade 632 is tilted, creating an angle between the blade surface of each blade 632 and the central axis of the aspiration catheter 20, i.e., the blade 632 is in an inclined state. It can be understood that the tilted blade 632 can obliquely cut the thrombus impurities 3, thereby more efficiently breaking up the thrombus impurities 3 and improving the thrombectomy efficiency.

[0098] Optionally, the second control mechanism of the operating handle 65 may be equipped with a reference point to indicate the arc of the counter-rotation of the first and second adjusting rings, thereby indicating the yaw angle of the blade surface of each blade 632. This reference point may be the angle reference disk 6514 in the aforementioned embodiment (see...). Figure 12 It can also be other reference components with multiple reference points, which will not be elaborated here.

[0099] It is understood that in any of the aforementioned embodiments of the bolt breaking device 1, the distal end of the bolt breaking rod 61 can be provided with a bolt breaking mechanism 63 to improve the bolt breaking efficiency, which will not be elaborated further.

[0100] Optionally, in some embodiments, the outer surface of the aspiration catheter 20 is provided with a first hydrophilic coating, and / or the outer surface of the fragmented embolus 61 is provided with a second hydrophilic coating at least at its distal end. Preferably, both the outer surfaces of the aspiration catheter 20 and the fragmented embolus 61 are provided with hydrophilic coatings. The first and second hydrophilic coatings can be Surcross hydrophilic super-lubricating coatings, hydrophilic coatings of methyl ethyl ether anhydrous maleic acid copolymer, polyvinylpyrrolidone, polyacrylic acid, or silica coatings, etc., preferably Surcross hydrophilic super-lubricating coatings with blood compatibility and a low coefficient of friction.

[0101] Understandably, applying a first hydrophilic coating to the outer surface of the aspiration catheter 20 facilitates its insertion into the blood vessel 2, reduces interfacial damage between the aspiration catheter 20 and human tissue, and allows the aspiration catheter 20 to move more smoothly back and forth within the blood vessel 2. Applying a second hydrophilic coating to the outer surface of the thrombectomy rod 61 facilitates its insertion into the lumen of the aspiration catheter 20 and its distal end into the blood vessel 2. This reduces frictional resistance between the thrombectomy rod 61 and the aspiration catheter 20, as well as interfacial damage with the inner wall of the blood vessel 2, and allows the thrombectomy rod 61 to move and / or rotate more smoothly within the lumen of the aspiration catheter 20 and within the blood vessel 2.

[0102] The following is combined with Figures 1 to 3 ,and Figure 5 Taking the thrombus fragmentation device 1, which is equipped with an operating handle 65, a connecting tube 80 and a thrombus fragmentation mechanism 63, as an example, the process of using the thrombus fragmentation device 1 of this application to aspirate thrombus impurities 3 in a blood vessel 2 is described.

[0103] The first step involves inserting the thrombectomy rod 61 of the thrombectomy device 60 from the proximal end of the main tube 83 into the inner cavity of the first inner cavity 81 and the inner cavity of the suction catheter 20. The thrombectomy mechanism 63 at the distal end of the thrombectomy rod 61 is located in the distal inner cavity of the suction catheter 20. It should be noted that the suction power device 40 is not yet connected to the end of the secondary tube 84 away from the main tube 83.

[0104] The second step, as Figure 3 As shown, the guide wire lumen of the thrombus fragmentation rod 61 is inserted into the guide wire and guided by the guide wire to reach the lesion site of the blood vessel 2, so that the distal end of the thrombus fragmentation device 1 abuts against the thrombus impurity 3. At this time, a drug injector can be connected through the auxiliary tube body 84 to deliver drugs to the lesion site of the blood vessel 2 to soften the thrombus impurity 3.

[0105] Third, after the drug injection is completed, the drug syringe is removed from the auxiliary tube 84, and then the tube 43 of the suction power device 40 is connected to the auxiliary tube 84. Finally, the suction power device 40 is used to provide suction power, so that the thrombus impurities 3 begin to enter the suction catheter 20 under the action of suction power, and enter the pump body 41 in sequence through the gap between the inner wall of the suction catheter 20 and the outer wall of the thrombus fragment rod 61, the notch 21, the second inner cavity 82, and the inner cavity of the tube 43.

[0106] Fourthly, when thrombus impurities 3 block the aspiration port of the aspiration catheter 20, the distal end of the thrombus fragmentation rod 61 is extended from the distal end of the aspiration catheter 20 by holding the operating handle 65, and moves and / or rotates axially within the aspiration catheter 20 to push away or break up the thrombus impurities 3, thereby achieving rapid aspiration of the thrombus impurities 3. It should be noted that this step is not necessary when there are no thrombus impurities 3 blocking the aspiration port.

[0107] Fifth, when a hardened, coagulated thrombus impurity 3 blocks the aspiration port of the aspiration catheter 20, the thrombus fragmentation mechanism 63 is controlled by the operating handle 65 to break up the thrombus impurity 3, thereby resolving the problem of thrombus blockage at the aspiration port. Similarly, when there is no hardened, coagulated thrombus impurity 3 blocking the aspiration port, this step is not required.

[0108] In summary, in the thrombus fragmentation device 1 provided in this application, the thrombus fragmenter 60 is movably inserted into the inner lumen of the aspiration catheter 20. When thrombus impurities 3 block the distal end of the aspiration catheter 20, the operator can control the thrombus fragmenter 60 to move and / or rotate axially within the inner lumen of the aspiration catheter 20, thereby extending the distal end of the thrombus fragmenter 60 out of the distal end of the aspiration catheter 20 to push away or crush the thrombus impurities 3 blocking the distal end of the aspiration catheter 20, preventing the thrombus impurities 3 from blocking the aspiration port of the aspiration catheter 20, thus achieving efficient thrombus fragmentation. Moreover, the thrombus fragmentation device 1 is manually operated during use, which is convenient and safe, and can better protect the inner wall of the blood vessel 2.

[0109] In the description of this specification, the references to terms such as "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0110] Although embodiments of this application have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of this application, the scope of which is defined by the claims and their equivalents.

Claims

1. A bolt-breaking device, characterized in that, include: Aspiration catheter, having an inner lumen that extends axially through both ends; A suction power device is connected to the inner lumen of the suction catheter to provide suction power to draw out thrombus impurities from the blood vessels through the suction catheter, and to contain the drawn-out thrombus impurities through its own volume. as well as A thrombectomy device includes a thrombectomy rod and a thrombectomy mechanism; the thrombectomy rod is movably inserted into the lumen of the aspiration catheter, and after the distal end of the thrombectomy rod extends from the distal end of the aspiration catheter, the thrombectomy rod reciprocates axially and / or rotates to push away or crush the thrombus impurities blocking the distal end of the aspiration catheter; the thrombectomy mechanism is disposed at the distal end of the thrombectomy rod, and the thrombectomy mechanism is a turbine structure, including at least one rotatable blade and a protective shell fixedly connected to each blade and surrounding the periphery of the blade; The protective shell includes a first ring and a second ring, which are spaced apart along the axial direction of the broken bolt and are respectively fixedly connected to the proximal and distal ends of the outer edge of each fan blade; at least one of the first ring and the second ring is connected to a second control mechanism, which drives the first ring and the second ring to reverse relative to each other to adjust the yaw angle of the blade surface of each fan blade.

2. The bolt-breaking device as described in claim 1, characterized in that, It also includes connecting pipes; The connecting pipe has a first inner cavity that extends axially through both ends of the pipe and a second inner cavity that communicates with the first inner cavity. The proximal end of the suction catheter is inserted into the first inner lumen, and the inner lumen of the suction catheter is connected to the first inner lumen and the second inner lumen respectively. The suction power device is connected to the inner cavity of the suction conduit via the second inner cavity; The thrombectomy device is movably inserted from the proximal end of the first inner lumen into the first inner lumen and the inner lumen of the aspiration catheter.

3. The thrombus-breaking device as described in claim 1, characterized in that, The distal end of the thrombectomy rod has a pre-bent shaping section, which allows the distal end of the thrombectomy rod to bend after extending from the distal end of the aspiration catheter.

4. The bolt-breaking device as described in claim 1, characterized in that, The distal end of the thrombectomy rod has at least one adjustable bend, and the thrombectomy device further includes at least one set of bend adjustment components, which are used to adjust the bending of the corresponding adjustable bend after the distal end of the thrombectomy rod extends from the distal end of the suction catheter.

5. The bolt-breaking device as described in claim 4, characterized in that, The bending assembly includes an anchoring ring fixedly disposed at the distal end of the broken bolt rod, and at least one traction wire movably inserted into the broken bolt rod, one end of the traction wire being fixedly connected to the anchoring ring, and the other end extending from the proximal end of the broken bolt rod.

6. The bolt-breaking device as described in claim 1, characterized in that, The hardness of the fan blades is greater than the hardness of the protective shell.

7. The bolt-breaking device as described in claim 1, characterized in that, The thrombus breaker also includes an operating handle connected to the proximal end of the thrombus breaker rod, the operating handle being used to control the axial movement and / or rotation of the thrombus breaker rod.

8. The bolt-breaking device as described in claim 7, characterized in that, The distal end of the bolt breaking rod has at least one adjustable bend, and the bolt breaking device further includes at least one set of bend-adjusting components; The proximal end of the bending assembly is connected to a first control mechanism on the operating handle. The first control mechanism is used to control the movement of the bending assembly to adjust the bending angle of the adjustable bending segment.

9. The bolt-breaking device as described in claim 1, characterized in that, The second control mechanism is located on the operating handle.

10. The bolt-breaking device as described in claim 1, characterized in that, The outer surface of the suction catheter is provided with a first hydrophilic coating, and / or the outer surface of the thrombus rod is provided with a second hydrophilic coating at least at its distal end.

11. The bolt-breaking device as described in claim 2, characterized in that, The inner wall of the first inner cavity is provided with a stop structure, and the connection between the first inner cavity and the second inner cavity and the port at the proximal end of the first inner cavity are respectively located on both sides of the stop structure; the outer wall of the suction catheter has a notch near its proximal end that connects to the inner cavity. When the proximal end of the suction catheter is inserted into the first inner lumen, the proximal end of the suction catheter abuts against the stop structure, and the notch corresponds to the communication between the first inner lumen and the second inner lumen, so that the second inner lumen is connected to the inner lumen of the suction catheter.

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