An ultrasonic calcification breaking system

Abstract

This invention discloses an ultrasonic calcification fragmentation system, relating to the field of thrombus fragmentation medical device technology, including an external catheter, an ultrasonic fragmentation assembly, and a rotary fragmentation assembly. The ultrasonic fragmentation assembly includes an internal catheter, a cutting cage, and a filter. The proximal end of the internal catheter is used to connect to the output end of an ultrasonic transducer. The cutting cage includes multiple cutting wires spaced circumferentially. There are gaps between adjacent cutting wires that allow calcified plaques to enter the cutting cage. The filter is disposed at the proximal and distal ends of the cutting cage, and the filter has a contracted state under radial force restriction and an expanded state after the radial force is eliminated. The rotary fragmentation assembly includes a guide wire and a fragmenter. The guide wire passes through the internal catheter, and the proximal end of the guide wire is connected to a rotary force-applying end. The proximal end of the fragmenter is connected to the distal end of the guide wire and can extend into the cutting cage along with the distal end of the guide wire. This invention can effectively treat severe plaques, and the treatment efficiency is significantly improved.

Description

Technical Field

[0001] This invention relates to the field of thrombus fragmentation medical device technology, and in particular to an ultrasonic calcification fragmentation system. Background Technology

[0002] Percutaneous coronary intervention (PCI) and peripheral vascular intervention (PCI) are common methods for treating calcified lesions. However, severe calcified lesions, due to their hard texture and irregular shape, remain a challenge in interventional treatment. Currently, the active fragmentation devices used clinically to treat such calcified lesions mainly include ultrasonic ablation guidewires and mechanical rotational atherectomy / dissection devices. However, in practical applications, existing devices generally have the following technical limitations: Firstly, fragmentation devices based on a single vibration principle, such as ultrasonic ablation guidewires, work by generating high-frequency longitudinal vibrations at the tip of the guidewire to contact and break up calcified plaques. However, the fragmentation area of ​​such devices is extremely limited, mainly concentrated in the point-like or short-line contact area at the tip of the guidewire. For severely calcified lesions with annular, nodular, or diffuse distribution, single point / line contact vibration is insufficient to achieve comprehensive and uniform plaque reduction, resulting in low fragmentation efficiency and often a high rate of residual stenosis after the procedure.

[0003] Secondly, mechanical instruments, such as rotary abrasives, orbital rotary cutters, or rotary cutters for conduits, physically grind or cut calcified plaques using high-speed rotating grinding heads or blades. These instruments have two significant drawbacks: Risk of vascular injury: When the mechanical grinding head rotates at high speed, its hardness is much higher than that of calcified plaques and normal blood vessel walls. During operation, it is very easy for eccentric rotational grinding or grinding head embedding to occur, which can cause mechanical damage to the intima and even the media of blood vessels in non-lesion areas, leading to serious complications such as vascular dissection and perforation.

[0004] Lack of debris management mechanisms: More critically, existing mechanical rotary augers and rotary cutters lack effective debris collection or removal structures. A large number of micron- to millimeter-sized calcified particles generated during the grinding or cutting process can directly detach and enter the bloodstream. These intravascular free debris can easily drift with the blood flow to distal vessels, causing distal vascular embolism, leading to no-reflow, slow flow, and even myocardial damage in coronary artery treatment, or distal lower limb ischemia or "waste foot" in peripheral vascular treatment.

[0005] In summary, existing interventional devices for fragmenting vascular calcification suffer from common technical bottlenecks, including limited fragmentation efficiency, easy damage to normal vessel walls, and ineffective management of fragmented debris. Therefore, providing an interventional device that can efficiently fragment heavily calcified plaques while maximally protecting the vessel wall and simultaneously recovering fragmented debris to prevent distal embolism is a pressing technical problem that needs to be solved by those skilled in the art. Summary of the Invention

[0006] The purpose of this invention is to provide an ultrasonic calcification fragmentation system to solve the problems existing in the prior art, which can effectively treat severe plaques and significantly improve the processing efficiency.

[0007] To achieve the above objectives, the present invention provides the following solution: An ultrasonic calcification disruption system includes an outer conduit, an ultrasonic disruption assembly, and a rotary disruption assembly. The ultrasonic disruption assembly includes an inner conduit, a cutting cage, and a filter. The inner conduit is capable of passing through the outer conduit. The proximal end of the inner conduit is connected to the output end of an ultrasonic transducer to receive vibrational energy. The cutting cage includes multiple cutting wires spaced circumferentially, each cutting wire having at least a cutting portion parallel to the axial direction of the inner conduit. A gap exists between adjacent cutting wires, allowing calcified plaques to enter the cutting cage. The filter is disposed at the proximal and distal ends of the cutting cage, and the filter has a radial action... The filter screen is in a conical shape in its contracted state under force constraint and in its expanded state after the radial force is eliminated. In the expanded state, the filter screen is connected to the cutting wire at its large diameter end and to the inner guide tube at its small diameter end, or it can be freely disposed therein. The rotary crushing assembly includes a guide wire and a crusher. The guide wire passes through the inner guide tube, and the proximal end of the guide wire is connected to the rotary force-applying end to transmit torque. The proximal end of the crusher is connected to the distal end of the guide wire and can extend into the cutting cage along with the distal end of the guide wire. The crusher is strip-shaped, and when the guide wire rotates, the crusher crushes the calcified plaques under the action of centrifugal force.

[0008] In one embodiment, the filter screen includes multiple support wires distributed circumferentially and a filter membrane. One end of each support wire is connected to the cutting wire, and the other end is connected to the inner conduit or to a single point. Under radial force, the multiple support wires converge. After the radial force is eliminated, the multiple support wires unfold to form a conical support surface. The filter membrane is fixed on the conical support surface. The filter membrane has filter pores that intercept calcified plaques and allow blood to flow through.

[0009] As one embodiment, the outer contour of the cutting cage is cylindrical.

[0010] In one embodiment, the crusher includes a plurality of rings arranged in series, with the proximal rings fixedly connected to the distal end of the guide wire, and the distal rings freely disposed.

[0011] In one embodiment, the crusher is provided with two wires, and the connection positions of the two crushers and the guide wire are respectively located on both sides of the axis of the guide wire, and are symmetrical with respect to the axis of the guide wire.

[0012] As one embodiment, the distal end of the ultrasonic fragmentation component is connected to a conductive component, which is used to drill a channel in the calcified thrombus.

[0013] In one embodiment, the conductive assembly includes a coiled spring and a breaking head fixed to the distal end of the coiled spring, with the proximal end of the coiled spring fixedly connected to the distal end of the ultrasonic breaking assembly.

[0014] As one embodiment, the proximal end of the guidewire is connected to a rotary joint, and the proximal end of the inner catheter is provided with an adapter for connecting to the output end of the ultrasonic transducer.

[0015] As one embodiment, the distal sidewall of the external catheter has a radiopaque ring, and the proximal end is connected to a catheter seat. The catheter seat has a seat cavity and a first operating port communicating with the seat cavity. The seat cavity is communicating with the proximal end of the external catheter, and the proximal ends of the internal catheter and the guidewire are exposed in the first operating port.

[0016] As one embodiment, the catheter seat is also provided with a second operating port that communicates with the catheter seat cavity, and the second operating port is connected to an injection valve.

[0017] Compared with the prior art, the present invention has the following technical effects: This invention utilizes a cutting cage with circumferentially spaced cutting wires to perform small-scale cutting of calcified plaques, resulting in higher cutting efficiency under the same vibration energy and facilitating the cutting of heavily damaged plaques. Simultaneously, gaps are created between adjacent cutting wires, allowing calcified plaques to enter the cutting cage, where a crusher further breaks them up using rotation. Under the cutting action of the wires, the calcified plaques inside the cutting cage are toothed (viewed from proximal to distal), making rotational crushing easier and promoting thorough fragmentation. Therefore, this invention, by combining ultrasonic vibration cutting with rotational crushing, effectively treats heavily damaged plaques with significantly improved processing efficiency.

[0018] In addition, in this invention, the crusher is placed inside the cutting cage, which can provide some protection for the blood vessels and prevent the crusher from damaging the blood vessels during the crushing process. Moreover, this invention has filters at both the proximal and distal ends of the cutting cage, which can collect the small plaques generated during the crushing process and prevent distal vascular embolism. Attached Figure Description

[0019] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0020] Figure 1 This is a schematic diagram of the ultrasonic calcification and fragmentation system in one embodiment of the present invention (the filter screen is in a retracted state). Figure 2 for Figure 1 A magnified view of part A in the image; Figure 3 This is a schematic diagram of the ultrasonic calcification and fragmentation system in one embodiment of the present invention (the filter screen is in the unfolded state). Figure 4 for Figure 3 A magnified view of part B in the image; Figure 5 This is a schematic diagram of the external catheter structure in one embodiment of the present invention; Figure 6 for Figure 5 A magnified view of part C; Figure 7 This is a schematic diagram of the ultrasonic crushing component in one embodiment of the present invention (the filter screen is in a compressed state). Figure 8 for Figure 7 A magnified view of part D; Figure 9 This is a schematic diagram of the ultrasonic crushing component in one embodiment of the present invention (the filter screen is in the unfolded state). Figure 10 for Figure 9 A magnified view of part E in the image; Figure 11 This is a schematic diagram of the structure of a rotary crushing component in one embodiment of the present invention (the guide wire is not rotating). Figure 12 for Figure 11 A magnified view of part of F; Figure 13 This is a schematic diagram of the structure of a rotary crushing component (guide wire rotation) in one embodiment of the present invention. Figure 14 for Figure 13 A magnified view of a portion of G; Figure 15 This is a schematic diagram of the structure of an ultrasonic transducer in one embodiment of the present invention; Figure 16 This is a schematic diagram of the structure of an ultrasonic host in one embodiment of the present invention; Figure 17 This is a schematic diagram of the foot switch in one embodiment of the present invention; Figure 18 This is a schematic diagram of the structure of the ultrasonic calcification fragmentation system after it has just been inserted into a blood vessel, according to one embodiment of the present invention. Figure 19This is a schematic diagram of a structure for drilling channels in calcified patches using a coiled spring, according to one embodiment of the present invention. Figure 20 This is a schematic diagram of a structure in one embodiment of the present invention, in which the filter screen is in an unfolded state and the guide wire is rotated to break it. Figure 21 In order to be in Figure 20 A schematic diagram of the structure after continuous fracturing based on the state shown.

[0021] Figure label: 1. Outer catheter; 2. Inner catheter; 3. Cutting cage; 4. Filter screen; 5. Guide wire; 6. Crusher; 7. Imaging ring; 8. Adapter; 9. Rotary joint; 10. Spring; 11. Crusher head; 12. Catheter seat; 13. Injection valve; 14. Ultrasonic transducer; 15. Ultrasonic unit; 16. Foot switch. Detailed Implementation

[0022] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] The purpose of this invention is to provide an ultrasonic calcification fragmentation system to solve the problems existing in the prior art, which can effectively treat severe plaques and significantly improve the processing efficiency.

[0024] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0025] like Figures 1-21As shown, this embodiment provides an ultrasonic calcification disruption system, including an outer catheter 1, an ultrasonic disruption assembly, and a rotary disruption assembly. The outer catheter 1 serves as the insertion channel for both the ultrasonic and rotary disruption assemblies. The ultrasonic disruption assembly includes an inner catheter 2, a cutting cage 3, and a filter 4. The inner catheter 2 can pass through the outer catheter 1 and slide along its length. The proximal end of the inner catheter 2 is connected to the output end of an ultrasonic transducer 14 to receive vibrational energy and transmit it to the distal end of the inner catheter 2. Preferably, the inner catheter 2 is made of a metal material, such as stainless steel, to ensure excellent energy conduction. The cutting cage 3 includes multiple cutting wires spaced circumferentially. Each cutting wire has at least a cutting portion parallel to the axial direction of the inner catheter 2, used to cut calcified plaques. There are gaps between adjacent cutting wires that allow calcified plaques to enter the cutting cage 3. Two filters 4 are provided, one at the proximal end and one at the distal end of the cutting cage 3. The filters 4 have pores that allow blood to pass through and capture small plaque particles. The filter screen 4 has a contracted state under radial force constraint and an expanded state after the radial force is eliminated. Since the filter screen 4 is connected to the cutting wire in the cutting cage 3, when the filter screen 4 is in the contracted state, the cutting cage 3 is also in the contracted state; when the filter screen 4 is in the expanded state, the cutting cage 3 is also in the expanded state. In the expanded state, the filter screen 4 is conical in shape, with its opening facing the cutting cage 3. The large-diameter end of the filter screen 4 is connected to the cutting wire, and the small-diameter end is connected to or freely positioned within the inner guide tube 2. Specifically, in the filter screen 4 located near the cutting cage 3, the large-diameter end (i.e., the distal end of this filter screen 4) is connected to the proximal end of the cutting cage 3, and the small-diameter end (i.e., the proximal end of this filter screen 4) is fixedly connected to the inner guide tube 2. In the filter screen 4 located at the distal end of the cutting cage 3, the large-diameter end (i.e., the proximal end of this filter screen 4) is connected to the distal end of the cutting cage 3, and the small-diameter end (i.e., the distal end of this filter screen 4) can be freely positioned.

[0026] The rotary crushing assembly includes a guide wire 5 and a crusher 6. The guide wire 5 is inserted into the inner guide tube 2, and the proximal end of the guide wire 5 is connected to the rotary force-applying end to transmit torque. The proximal end of the crusher 6 is connected to the distal end of the guide wire 5 and can extend into the cutting cage 3 along with the distal end of the guide wire 5. The crusher 6 is strip-shaped, and when the guide wire 5 rotates, the crusher 6 crushes the calcified plaques under the action of centrifugal force.

[0027] When using, such as Figures 18-21As shown, the external catheter 1 is inserted into the affected area, and then the internal catheter 2 is inserted into the external catheter 1 and placed inside the body. When the internal catheter 2 is inside the external catheter 1, the external catheter 1 restricts the cutting cage 3, and the cutting cage 3 is in a contracted state within the external catheter 1. The guidewire 5 is inserted into the internal catheter 2 and can be pushed distally synchronously with the internal catheter 2. The disruptor 6 can also be located within the contracted cutting cage 3 at this time, and the disruptor 6 is in a straight state. When the cutting cage 3 is pushed out of the external catheter 1, the cutting cage 3 is no longer restricted by the external catheter 1 and is in an unfolded state. After the cutting cage 3 is pushed into the area where the calcified plaque is located, the cutting cage 3 will also contract to a certain extent under the compression of the calcified plaque, so that the cutting wire of the cutting cage 3 comes into contact with the calcified plaque. After the ultrasonic transducer 14 is turned on, the internal catheter 2 transmits vibration energy to the cutting cage 3, and the cutting wire of the cutting cage 3 cuts the calcified plaque under the support of vibration energy. Since the cutting cage 3 does not rotate, the vibration cutting range of the cutting wire is limited. As the cutting wire cuts and removes the nearby calcified patches, the cutting cage 3 and the filter screen 4 (which may be the filter screen 4 at one end or both ends) gradually unfold, ensuring that the cutting wire of the cutting cage 3 is always in contact with the calcified patches and can continuously cut. Because the cutting range of the cutting wire in this embodiment is limited and the cutting wires are sparsely distributed, there will be uncut calcified patches between adjacent cutting wires. These patches will extend into the cutting cage 3 through the gaps between adjacent cutting wires. At this time, rotating the guide wire 5 drives the crusher 6 to rotate. Under the action of centrifugal force, the strip-shaped crusher 6 is thrown apart, crushing the calcified patches that have penetrated into the cutting cage 3 during the rotation process. During the crushing process, the crusher 6 can move the guide wire 5 back and forth along the extension direction of the guide wire 5, allowing the crusher 6 to move back and forth within the cutting cage 3 to achieve sufficient crushing of the calcified patches. The calcified particles generated by the cutting wire and the calcifier 6 are captured by the filters 4 at the distal and proximal ends of the cutting cage 3, preventing them from traveling with the blood to the distal end of the blood vessel and causing the risk of embolism. Once the calcified plaque has been broken up, the guidewire 5, inner catheter 2, and outer catheter 1 can be withdrawn from the body.

[0028] Existing ultrasonic thrombectomy devices, such as the thrombectomy guide wire 5, have a small thrombectomy area and poor fragmentation effect along with calcified plaques near the vessel wall; the thrombectomy mesh has a larger thrombectomy area, but it also requires more ultrasonic energy, and its dense mesh results in an unsatisfactory fragmentation effect.

[0029] This embodiment utilizes a cutting cage 3 and circumferentially spaced cutting wires to perform small-scale cutting of calcified patches, resulting in higher cutting efficiency under the same vibration energy and facilitating the cutting of heavily damaged patches. Simultaneously, gaps are formed between adjacent cutting wires, allowing calcified patches to enter the cutting cage 3. A crusher 6 inside the cutting cage 3 then performs rotary crushing on the patches extending into the cage. Under the cutting action of the wires, the calcified patches extending into the cutting cage 3 are toothed (viewed from the proximal end to the distal end), making rotary crushing easier and facilitating thorough crushing. Therefore, this embodiment, by combining ultrasonic vibration cutting with the rotary crushing of the crusher 6, effectively treats heavily damaged patches with significantly improved processing efficiency.

[0030] In addition, in this embodiment, the crusher 6 is placed inside the cutting cage 3. The cutting cage 3 can play a certain protective role for blood vessels, preventing the crusher 6 from damaging blood vessels during the crushing process. Moreover, in this embodiment, filter screens 4 are provided at both the proximal and distal ends of the cutting cage 3, which can collect small plaques generated during the crushing process and prevent distal blood vessel embolism.

[0031] In this embodiment, the filter screen 4 includes multiple support wires distributed circumferentially and a filter membrane. The support wires are made of metal, providing both support and vibration energy transmission. They can be made of the same material as the cutting wire, such as a nickel-chromium alloy, and can deform under external force and return to their original shape after the force is removed. One end of the support wire is connected to the cutting wire, and the other end is connected to the inner conduit 2 or connected to a single point. In the filter screen 4 located at the distal end of the cutting cage 3, the distal ends of the multiple support wires are connected to a single point; in the filter screen 4 located at the proximal end of the cutting cage 3, the proximal ends of the multiple support wires are fixedly connected to the inner conduit 2. Under radial force, the multiple support wires converge; after the radial force is removed, the multiple support wires unfold to form a conical support surface, and the filter membrane is fixed on the conical support surface. The filter membrane has filter pores that intercept calcified plaques and allow blood to flow through.

[0032] In this embodiment, the outer contour of the cutting cage 3 is cylindrical. The cutting wire is parallel to the axial direction of the inner guide tube 2, and the cutting wire and the support wire are connected in a one-to-one correspondence.

[0033] In this embodiment, the cutting wires are sparsely distributed, with 10 to 18 wires evenly arranged along the axial direction. The specific number can be selected according to the actual situation to ensure that there is still a certain gap between adjacent cutting wires when they are in a contracted state. During the crushing and cutting process, the cutting wires can vibrate and cut independently, avoiding the problem of cutting wires being in close contact and multiple cutting wires connecting to form a surface, which would prevent effective cutting of calcified patches.

[0034] like Figures 11-14As shown, in this embodiment, the breaker 6 is strip-shaped in its natural state. When the guide wire 5 rotates, it is thrown open under the action of centrifugal force. The cutting diameter of the breaker 6 is related to the length of the breaker 6 and the rotation speed of the guide wire 5. The faster the rotation speed of the guide wire 5, the larger its cutting diameter. The maximum rotation diameter that the breaker 6 can achieve after unfolding is adapted to the inner diameter of the blood vessel, but it can be smaller than the maximum diameter that the cutting cage 3 can unfold in its natural state.

[0035] The crusher 6 in this embodiment includes multiple rings arranged in series. These rings are made of metal and possess a certain strength and hardness. The proximal ring is fixedly connected to the distal end of the guide wire 5, while the distal ring is freely positioned. After the multiple rings are connected in series, their outer contour along their length is approximately wavy. In the initial crushing stage, the cutting cage 3 cannot fully expand. Simultaneously, the calcified plaques extending into the cutting cage 3 also restrict the crusher 6 from fully expanding. Therefore, the crusher 6 cannot immediately unfold into a straight strip but instead forms a bent shape, with the distal portion of the bent shape nearly parallel to the cutting wire. The wavy surface of the crusher 6, formed by the multiple rings connected in series, generates significant friction upon contact with the calcified plaques, resulting in a good crushing effect.

[0036] In this embodiment, two crushers 6 are provided. The connection points of the two crushers 6 and the guide wire 5 are located on both sides of the axis of the guide wire 5, and are symmetrical with respect to the axis of the guide wire 5. When the guide wire 5 rotates, the two crushers 6 are thrown apart, and their rotation plane is a conical plane, which crushes the calcified plaques.

[0037] In this embodiment, the cutting cage 3 needs to be inserted into the area where the calcified plaque is located for expansion and cutting. If the calcified plaque in the affected area has a channel for the cutting cage 3 to be inserted, the cutting cage 3 can be used directly. If the area blocked by the calcified plaque is too large and the cutting cage 3 cannot be inserted, it is necessary to first drill a channel in the calcified plaque (which can be formed using ultrasonic emboli or other equipment), and then insert the cutting cage 3 into the channel for ultrasonic fragmentation.

[0038] To avoid repeatedly changing the thrombectomy tool, in this embodiment, the distal end of the ultrasonic fragmentation component is connected to a conductive component, which can drill a channel in the calcified thrombus under the action of vibration energy. Then, the cutting cage 3 is placed in the channel to fragment the thrombus.

[0039] In this embodiment, the conductive component includes a coiled spring 10 and a fragmentation head 11 fixed to the distal end of the coiled spring 10. The proximal end of the coiled spring 10 is fixedly connected to the distal end of the ultrasonic fragmentation component. Vibrational energy can be transmitted from the support wire and the cutting wire to the coiled spring 10 and the fragmentation head 11, which can drill a channel in the thrombus. In this embodiment, the fragmentation head 11 is hemispherical or spherical.

[0040] In this embodiment, the proximal end of the guidewire 5 is connected to a rotary joint 9, and the proximal end of the inner catheter 2 is provided with an adapter 8 for connecting to the output end of the ultrasonic transducer 14.

[0041] like Figure 5 , Figure 6 As shown, in this embodiment, the distal sidewall of the external catheter 1 has a radiopaque ring 7, and the proximal end is connected to a catheter seat 12. The catheter seat 12 has a seat cavity and a first operating port communicating with the seat cavity. The seat cavity is connected to the proximal end of the external catheter 1, and the proximal ends of the internal catheter 2 and the guidewire 5 are exposed in the first operating port.

[0042] In this embodiment, the catheter seat 12 is also provided with a second operating port that communicates with the catheter seat cavity. The second operating port is connected to an injection valve 13. The injection valve 13 can be a multi-port valve that can inject liquid drugs into the body through the external catheter 1.

[0043] This embodiment also includes an ultrasonic main control component, which includes an ultrasonic main unit 15 and a foot switch 16. The ultrasonic main unit 15 is communicatively connected to the ultrasonic transducer 14 via a wire, and is also connected to the foot switch 16 via a wire. The operator can start the ultrasonic transducer 14 by stepping on the foot switch 16. Figures 15-17 As shown.

[0044] Any adaptive changes made according to actual needs are within the scope of protection of this invention.

[0045] Specific examples have been used to illustrate the principles and implementation methods of this invention. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this invention. Furthermore, those skilled in the art will recognize that, based on the ideas of this invention, there will be changes in the specific implementation methods and application scope. Therefore, the content of this specification should not be construed as a limitation of this invention.

Claims

1. An ultrasonic calcification breaking system, characterized by, Includes external catheter, ultrasonic fragmentation assembly, and rotary fragmentation assembly; The ultrasonic fragmentation assembly includes: An inner catheter is inserted inside the outer catheter; the proximal end of the inner catheter is used to connect to the output end of an ultrasonic transducer to receive vibration energy. A cutting cage comprising a plurality of cutting wires spaced apart circumferentially, each cutting wire having at least a cutting portion parallel to the axial direction of the inner conduit; and gaps between adjacent cutting wires allowing calcified plaques to enter the cutting cage. The filter screen is disposed at the proximal and distal ends of the cutting cage. The filter screen has a contracted state under radial force constraint and an expanded state after the radial force is eliminated. The expanded state of the filter screen is conical in shape. The large diameter end of the filter screen is connected to the cutting wire, and the small diameter end is connected to the inner guide tube or is freely disposed. The rotary crushing assembly includes: A guidewire, which is inserted into the internal catheter, with its proximal end connected to a rotating force-applying end to transmit torque; The crusher has its proximal end connected to the distal end of the guide wire and can extend into the cutting cage along with the distal end of the guide wire; the crusher is strip-shaped, and when the guide wire rotates, the crusher crushes the calcified plaques under the action of centrifugal force.

2. The ultrasonic calcification breaking system of claim 1, wherein, The filter screen includes multiple support wires distributed circumferentially and a filter membrane. One end of each support wire is connected to the cutting wire, and the other end is connected to the inner conduit or to a single point. Under radial force, the multiple support wires converge. After the radial force is eliminated, the multiple support wires unfold to form a conical support surface. The filter membrane is fixed on the conical support surface. The filter membrane has filter pores that intercept calcified plaques and allow blood to flow through.

3. The ultrasonic calcification breaking system of claim 1, wherein, The outer contour of the cutting cage is cylindrical.

4. The ultrasonic calcification breaking system of claim 1, wherein, The crusher includes multiple rings arranged in series, with the proximal rings fixedly connected to the distal end of the guide wire, and the distal rings freely disposed.

5. The ultrasonic calcification fragmentation system according to claim 4, characterized in that, The crusher is provided with two parts, and the connection positions of the two crushers to the guide wire are respectively located on both sides of the axis of the guide wire, and are symmetrical with respect to the axis of the guide wire.

6. The ultrasonic calcification fragmentation system according to claim 1, characterized in that, The distal end of the ultrasonic fragmentation assembly is connected to a conductive assembly, which is used to drill a channel in the calcified thrombus.

7. The ultrasonic calcification fragmentation system according to claim 6, characterized in that, The conductive assembly includes a coiled spring and a crushing head fixed to the distal end of the coiled spring, with the proximal end of the coiled spring fixedly connected to the distal end of the ultrasonic crushing assembly.

8. The ultrasonic calcification fragmentation system according to claim 1, characterized in that, The guidewire is connected to a rotary joint at its proximal end, and the inner catheter is provided with an adapter at its proximal end for connecting to the output end of the ultrasonic transducer.

9. The ultrasonic calcification fragmentation system according to claim 1, characterized in that, The distal sidewall of the external catheter has a radiopaque ring, and the proximal end is connected to a catheter seat. The catheter seat has a seat cavity and a first operating port communicating with the seat cavity. The seat cavity is connected to the proximal end of the external catheter, and the proximal ends of the internal catheter and the guidewire are exposed at the first operating port.

10. The ultrasonic calcification fragmentation system according to claim 9, characterized in that, The catheter seat is also provided with a second operating port that communicates with the catheter seat cavity, and the second operating port is connected to an injection valve.

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