A cutting mechanism and ultrasonic cutting instrument

Abstract

The present application relates to the technical field of cutting catheter, and provides a cutting mechanism and an ultrasonic cutting instrument, which comprises an inner tube, an outer tube, a drilling part, a cutting wire and a pushing structure; the outer tube is sleeved outside the inner tube, and the outer tube can slide relative to the inner tube in the front-back direction; the drilling part is arranged at the front end of the inner tube; the cutting wire is arranged on the inner tube, and the cutting wire can be accommodated into the outer tube or extended out of the outer tube along with the inner tube; the cutting wire has a cutting section; the cutting section is located behind the drilling part; and the pushing structure is used for pushing the cutting section to move radially outward of the inner tube.

Description

Technical Field

[0001] This invention belongs to the technical field of cutting catheters, and more specifically, relates to a cutting mechanism and an ultrasonic cutting instrument. Background Technology

[0002] With an aging population and improved living standards, the incidence of vascular diseases is increasing year by year. Plaques in the blood vessel walls gradually evolve into calcified deposits, forming blockages that narrow the blood vessel lumen, leading to serious clinical manifestations such as myocardial ischemia, peripheral vascular disease, and cerebral dysfunction. Atherosclerosis is the main cause of cardiovascular disease, characterized by the proliferation of fibrous tissue and calcification of the arterial intima, resulting in narrowing of the blood vessel lumen.

[0003] Atherosclerotic lesions are a challenging and high-risk factor in interventional treatment, especially for severe calcified lesions or lesions with complex structures. Existing devices for treating severe calcified lesions include high-pressure balloons, scoring balloons, cutting balloons, and rotational atherectomy devices. While these devices can be effective in opening severely calcified stenotic lesions, they still have some insurmountable drawbacks. For example, high-pressure balloons and scoring balloons typically have good dilation capabilities for softer stenotic lesions (e.g., mild to moderate calcified stenosis), but their clinical efficacy is less than ideal for harder stenotic lesions (e.g., severe calcified stenosis), making it very difficult to open the blockage within the blood vessel.

[0004] For example, (Chinese Utility Model Patent; Publication No.: CN219847790U; Subject Name: A Double Balloon Dilatation Catheter; Publication Date: 2023.10.20) "Scratching wires / cutting wires" are set on the outer wall of the scratched balloon. Its working mechanism relies on the passive surface scratching of the balloon radial expansion. The scratching wires can hardly penetrate hard blockages by relying solely on the surface scratches formed by expansion and compression. There may still be situations where it "cannot be penetrated / cannot be dilated". In essence, it does not have the ability to directly penetrate lesions with severe calcification and stenosis.

[0005] The main reason why existing technologies face difficulties in treating severely calcified stenotic lesions is that these lesions are often accompanied by severe plaque calcification, resulting in highly hard and brittle plaques, while the vessel wall often exhibits pathological changes such as fibrosis. While high-pressure balloons can dilate blood vessels to some extent, their dilation effect is significantly limited when dealing with very hard calcified tissue, often resulting in the balloon being unable to penetrate. Although the blades or scoring structures of scoring balloons and cutting balloons can cut or score the plaque surface, they may still be unable to completely cut or break the plaque when encountering deep and dense calcified areas. Rotational atherectomy devices, while removing lesions through high-speed rotating burrs, face significantly increased operational difficulty and risk in complex vascular anatomy and severe calcification, and also have certain technical limitations. In summary, various instruments generally struggle to effectively penetrate and completely break deep and hard calcified plaques, posing challenges to both the efficiency and safety of intraoperative vascular opening, thus making it difficult to successfully open severely calcified stenotic lesions. Summary of the Invention

[0006] The purpose of this invention is to provide a cutting mechanism to solve the technical problem in the prior art that it is very difficult to open up the blockage in the narrow lesion of blood vessels with hard texture.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is: to provide an ultrasonic cutting instrument, comprising:

[0008] Inner tube;

[0009] Outer tube; the outer tube is sleeved on the outside of the inner tube, and the outer tube can slide relative to the inner tube in the front-back direction;

[0010] A drilling component; the drilling component is disposed at the front end of the inner tube;

[0011] A cutting wire; the cutting wire is disposed on the inner tube, and the cutting wire can be housed in the outer tube along with the inner tube or extend out of the outer tube; the cutting wire has a cutting section; the cutting section is located behind the drilling component;

[0012] A pushing structure; the pushing structure is used to push the cutting segment to move radially outward from the inner tube.

[0013] Furthermore, the actuation structure includes: a first balloon disposed on the inner tube; the cutting segment located radially outside the inner tube; and the first balloon located between the inner tube and the cutting segment.

[0014] Furthermore, there are multiple cutting wires, which are arranged sequentially along the circumference of the inner tube; the cutting segments on the multiple cutting wires are arranged sequentially around the first balloon.

[0015] Furthermore, the multiple cut segments are arranged to form a cavity, and the first balloon is located within the cavity.

[0016] Furthermore, the chamber surrounds the outside of the inner tube.

[0017] Furthermore, in the circumferential direction of the inner tube, any two adjacent cutting segments are spaced apart.

[0018] Furthermore, the outer tube has a channel extending along the length of the outer tube; one end of the cutting wire is connected to the inner tube, and the other end of the cutting wire is located in the channel and extends along the channel.

[0019] Furthermore, the number of the channels corresponds one-to-one with the number of the cutting wires.

[0020] Furthermore, the surface of the cutting wire is provided with drug grooves, and the drug grooves are filled with a drug layer.

[0021] Furthermore, the drug groove extends along the length direction of the cutting wire.

[0022] Furthermore, one end of the cutting wire connected to the inner tube is connected to the drilling component.

[0023] Furthermore, the surface of the cutting wire is smoothly connected to the surface of the drilling component.

[0024] Furthermore, the drilling component and the cutting wire are integrated into one piece.

[0025] Furthermore, the drilling element is rod-shaped and extends along the axial direction of the inner tube.

[0026] Furthermore, the inner tube has a guide wire channel; the guide wire channel extends along the inner tube.

[0027] Furthermore, the drilling component has an output hole that communicates with the guide wire channel.

[0028] Furthermore, the pushing structure includes: a hollow hole formed on the outer tube; the cutting wire is an integral piece made of elastic material; when the outer tube moves relative to the inner tube to a predetermined position, the cutting segment can pass through the hollow hole and extend to the outside of the outer tube under the elastic force of the cutting wire itself.

[0029] Further, the inner tube includes: a front section tube and a rear section tube that extend along a predetermined axis and are coaxially arranged; the front section tube and the rear section tube are spaced apart from each other; the edge of the front section tube near the rear section tube is a first annular edge, and the edge of the rear section tube near the front section tube is a second annular edge; one end of the cutting wire is connected to the first annular edge, and the other end of the cutting wire is connected to the second annular edge.

[0030] Furthermore, the propulsion structure further includes: a second balloon; there is an accommodating space located on the predetermined axis between the front tube and the rear tube, the second balloon is located within the accommodating space, and the cutting segment of the cutting wire is located on the expansion path of the second balloon.

[0031] Furthermore, the number of cutting wires is multiple; the multiple cutting wires are arranged in parallel to each other, or the multiple cutting wires are arranged in a cross shape.

[0032] Furthermore, each of the cutting wires extends along the predetermined axis, or

[0033] The angle between the extension direction of each cutting wire and the predetermined axis is greater than zero.

[0034] Furthermore, each of the cutting wires is wavy.

[0035] Furthermore, the drilling element is disposed at the front end edge of the front section pipe, and the drilling element is serrated perpendicular to or at an angle to the predetermined axis.

[0036] Furthermore, the drilling component and the front section pipe are an integral piece.

[0037] Furthermore, the number of the perforated holes is multiple; the number of perforated holes corresponds one-to-one with the number of cutting wires.

[0038] The present invention also provides an ultrasonic cutting device, comprising: an ultrasonic generator having a transmission ring and the cutting mechanism; the transmission ring being ultrasonically connected to the drilling component and the cutting wire respectively.

[0039] Furthermore, it also includes: a tube seat and a telescopic elastic tube; the tube seat is sleeved on the outside of the inner tube, the tube seat is located behind the outer tube, and the tube seat and the outer tube are spaced apart front and rear; the telescopic elastic tube is sleeved on the outside of the inner tube, and the telescopic elastic tube is located between the tube seat and the outer tube; the outer tube is connected to the tube seat through the telescopic elastic tube; the transfer ring is disposed on the tube seat.

[0040] Furthermore, it also includes a movable switch disposed on the outer tube.

[0041] The beneficial effects of the cutting mechanism provided by this invention are as follows: Compared with the prior art, the cutting mechanism provided by this invention has an outer tube sleeved outside the inner tube, and the outer tube can slide relative to the inner tube along the inner tube; the inner tube can be housed inside the outer tube, and the outer tube and the inner tube can enter the blood vessel together; a drilling element is provided at the front end of the inner tube, and when the outer tube moves relative to the inner tube to expose the drilling element, the user can push the inner tube to drill a hole in the blockage in the blood vessel through the drilling element; a cutting wire is provided on the inner tube, and the cutting wire can be housed in the outer tube along with the inner tube. The cutting wire has a cutting section, and the cutting section of the cutting wire is located behind the drilling element; after drilling is completed, a through hole is processed in the blockage, and the cutting wire can continue to move forward with the inner tube into the through hole; when the cutting section on the cutting wire enters... Once inside the through-hole, the outer tube is slid to expose the cutting segment of the cutting wire. The pushing mechanism moves the cutting segment radially outward from the inner tube to cut the inner wall of the through-hole. After cutting the inner wall of the through-hole, the blockage can be further cleared. In summary: For blockages in stenotic lesions with a hard texture, since the cutting segment of the cutting wire is located behind the drilling tool, a through-hole is first drilled in the blockage within the blood vessel through the drilling tool. After the blockage is drilled, its own structure is also destroyed, making it easier to further clear the blockage. When the cutting segment on the cutting wire enters the through-hole, the cutting segment can cut the inner wall of the through-hole under the push of the pushing mechanism. The cutting segment can cut the blockage from the inside out, making it easier to further clear and open the blockage. Attached Figure Description

[0042] Figure 1 A three-dimensional schematic diagram of an ultrasonic cutting instrument provided in an embodiment of the present invention. Figure 1 ;

[0043] Figure 2 for Figure 1 Enlarged view of point A in the middle;

[0044] Figure 3 A schematic front view (partial cross-section) of the ultrasonic cutting instrument provided in an embodiment of the present invention. Figure 1 ;

[0045] Figure 4 for Figure 3 Cross-sectional view of the middle section (BB);

[0046] Figure 5 This is a schematic diagram of the cross-section of the cutting wire provided in an embodiment of the present invention;

[0047] Figure 6 Left view of the ultrasonic cutting instrument provided in an embodiment of the present invention (rotated 90 degrees counterclockwise).

[0048] Figure 7 This is a schematic diagram of the structure of the drilling component before it enters the sealing material, as provided in an embodiment of the present invention.

[0049] Figure 8 This is a schematic diagram of the structure of the drilling component entering the sealing material according to an embodiment of the present invention;

[0050] Figure 9 A schematic diagram of the structure provided in this embodiment of the invention, showing the drilling component passing through the blockage, the first balloon beginning to expand, and the cutting segment cutting the blockage;

[0051] Figure 10 A schematic front view (partial cross-section) of an ultrasonic cutting instrument provided in another embodiment of the present invention. Figure 2 ;

[0052] Figure 11 for Figure 10 A schematic diagram of the ultrasonic cutting instrument before the drilling part enters the plug.

[0053] Figure 12 for Figure 10 A schematic diagram of the ultrasonic cutting instrument after the drilling part has passed through the blockage.

[0054] Figure 13 for Figure 10 The diagram shows the ultrasonic cutting instrument after the cutting wire is retracted into the inner tube.

[0055] Figure 14 for Figure 13 Enlarged view of point K;

[0056] Figure 15 for Figure 10 Top view of the perforated hole of the ultrasonic cutting instrument shown. Figure 1 ;

[0057] Figure 16 for Figure 10 Top view of the cutting wire of the ultrasonic cutting instrument shown. Figure 1 ;

[0058] Figure 17 for Figure 16 Cross-sectional view of DD in the middle;

[0059] Figure 18 for Figure 10 Top view of the perforated hole of the ultrasonic cutting instrument shown. Figure 2 ;

[0060] Figure 19 for Figure 10 Top view of the cutting wire of the ultrasonic cutting instrument shown. Figure 2 ;

[0061] Figure 20 for Figure 10 Top view of the perforated hole of the ultrasonic cutting instrument shown. Figure 3 ;

[0062] Figure 21 for Figure 10 Top view of the cutting wire of the ultrasonic cutting instrument shown. Figure 3 ;

[0063] Figure 22 for Figure 10 Top view of the perforated hole of the ultrasonic cutting instrument shown. Figure 4 ;

[0064] Figure 23 for Figure 10 Top view of the cutting wire of the ultrasonic cutting instrument shown. Figure 4 ;

[0065] Figure 24 A front view (partial cross-section) schematic diagram of an ultrasonic cutting device (equipped with a second balloon) provided for another embodiment of the present invention;

[0066] Figure 25 for Figure 10 The diagram shows the ultrasonic cutting instrument before the drilling part enters the plug (equipped with a second balloon);

[0067] Figure 26 for Figure 10 The diagram shows the ultrasonic cutting instrument after the drilling component passes through the blockage (with a second balloon).

[0068] Figure 27 for Figure 10 The diagram shows the ultrasonic cutting instrument after the cutting wire is retracted into the inner tube (with a second balloon).

[0069] The following are the labeling elements in the figure:

[0070] 11-Inner tube; 111-Front section tube; 112-Rear section tube; 113-Accommodation space; 12-Outer tube; 121-Channel; 122-Perforated hole; 13-Tube seat; 14-Telescopic elastic tube; 15-Movement switch; 16-Catheter seat; 21-Drilling component; 22-Cut wire; 221-Cut segment; 222-Drug reservoir; 223-Drug layer; 23-Pushing structure; 231-First balloon; 232-Second balloon; 24-Cavity; 3-Ultrasound generator; 31-Transmission ring; 32-Transducer; 33-Amplitude bar; 34-Main unit; 4-Occlusion material; 5-Blood vessel; L-Predetermined axis. Detailed Implementation

[0071] It should be noted that the specific embodiments are only used to explain the present invention and are not intended to limit the present invention.

[0072] It should be noted that, in the description of the embodiments of this application, unless otherwise stated, " / " means "or". For example, A / B can mean A or B. The "and / or" in this document is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, and B existing alone. Here, A and B can be singular or plural, respectively.

[0073] It should be noted that when a component is referred to as "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as "connected to" or "attached to" another component, it can be directly connected to or indirectly connected to that other component. When a component is referred to as "fixed to" or "set on" another component, it can be directly on or indirectly on that other component.

[0074] It should be noted that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not 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 the present invention.

[0075] It should be noted that the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include one or more of that feature.

[0076] It should be noted that the term "multiple" means two or more, unless otherwise explicitly specified.

[0077] Please refer to the following: Figures 1 to 9 The cutting mechanism provided by the present invention will now be described. The cutting mechanism includes: an inner tube 11, an outer tube 12, a drilling component 21, a cutting wire 22, and a pushing structure 23; the outer tube 12 is sleeved on the outside of the inner tube 11, and the outer tube 12 can slide relative to the inner tube 11 (in one embodiment, the outer tube 12 can slide relative to the inner tube 11 in the front-back direction); the drilling component 21 is disposed at the front end of the inner tube 11; the cutting wire 22 is disposed on the inner tube 11, and the cutting wire 22 can be housed in the outer tube 12 along with the inner tube 11, or the cutting wire 22 can extend out of the outer tube 12 along with the inner tube 11; the cutting wire 22 has a cutting section 221; the cutting section 221 is located behind the drilling component 21; the pushing structure 23 is used to push the cutting section 221 to move radially outward from the inner tube 11.

[0078] Thus, the outer tube 12 is fitted outside the inner tube 11, and the outer tube 12 can slide relative to the inner tube 11 along the inner tube 11; the inner tube 11 can be housed inside the outer tube 12, and the outer tube 12 and the inner tube 11 can enter the blood vessel 5 together; the front end of the inner tube 11 is provided with a drilling element 21, and when the outer tube 12 moves relative to the inner tube 11 to expose the drilling element 21, the user can directly (or indirectly) push the inner tube 11 to drill a hole in the blockage 4 in the blood vessel 5 through the drilling element 21; the inner tube 11... A cutting wire 22 is provided, which can be housed in the outer tube 12 along with the inner tube 11. The cutting wire 22 has a cutting section 221, which is located behind the drilling component 21. After drilling is completed, a through hole is machined on the plug 4, and the cutting wire 22 can continue to move forward with the inner tube 11 into the through hole. After the cutting section 221 on the cutting wire 22 enters the through hole, the outer tube 12 is slid so that the cutting section 221 of the cutting wire 22 can be pulled out from the outer tube 12. The exposed cutting segment 221 can be moved radially outward from the inner tube 11 by the pushing structure 23 (i.e., under the pushing of the pushing structure 23, the cutting segment 221 can move radially along the inner tube 11 and gradually move away from the inner tube 11) to cut the inner wall of the through hole on the blockage 4. After the cutting segment 221 cuts the inner wall of the through hole on the blockage 4, the blockage 4 can be further cleaned. In summary, for the blockage 4 in a hard stenotic lesion, due to the cutting segment 221 of the cutting wire 22 Located behind the drilling component 21, the drilling component 21 first drills a through hole in the blockage 4 inside the blood vessel 5; after the blockage 4 is drilled through, its own structure is also destroyed, making it easier to clean the blockage 4 in the future; when the cutting segment 221 on the cutting wire 22 enters the through hole, the cutting segment 221 can cut the inner wall of the through hole under the push of the pushing structure 23. The cutting segment 221 can cut the blockage 4 from the inside to the outside, making it easier to clean and open the blockage 4.

[0079] In one embodiment, the cutting wire 22 is made of a metallic material. In one embodiment, the cutting wire 22 is made of any one of the following materials: nickel-titanium alloy, cobalt-chromium alloy, or stainless steel.

[0080] In one embodiment, the inner tube 11 and the outer tube 12 are both made of polymer materials. In one embodiment, the inner tube 11 is made of any one of the following materials: polyurethane, polytetrafluoroethylene, nickel-titanium alloy, and polyether block amide. In one embodiment, the outer tube 12 is made of any one of the following materials: polyurethane, polytetrafluoroethylene, nickel-titanium alloy, and polyether block amide.

[0081] In one embodiment, the occluder 4 is a calcified plaque accumulated within the blood vessel 5.

[0082] In one embodiment, the inner tube 11 has a saline infusion chamber, through which the user can infuse and deliver saline solution along the inner tube 11.

[0083] In one embodiment, the inner tube 11 is provided with a catheter seat 16, through which the user can inject physiological saline into the saline infusion cavity.

[0084] In one embodiment, Figure 7 , Figure 8 , Figure 9 The diagrams shown are as follows: Figure 6 Cross-sectional views of different embodiments where CC is located.

[0085] Further, please refer to Figures 1 to 9 As a specific embodiment of the cutting mechanism provided by the present invention, the pushing structure 23 includes: a first balloon 231 disposed on the inner tube 11; a cutting segment 221 located radially outward of the inner tube 11; and the first balloon 231 located between the inner tube 11 and the cutting segment 221. Thus, when the first balloon 231 inflates, it can push the cutting segment 221 radially outward of the inner tube 11. When the cutting segment 221 moves radially outward of the inner tube 11, it can cut the blockage 4 within the blood vessel 5 outside the inner tube 11 radially outward. Specifically, the purpose of adding the first balloon 231 between the inner tube 11 and the cutting wire 22 is to utilize the inflatable characteristics of the first balloon 231 to further improve the controllability of the outward radial expansion of the cutting wire 22, thereby achieving a more precise and efficient cutting effect on calcified plaques. When the first balloon 231 is not inflated, the cutting wire 22 is attached to the surface of the first balloon 231 or stored in the outer tube 12. When the first balloon 231 is inflated, it expands and pushes the cutting segment 221 radially outward, allowing the cutting segment 221 to cut towards the lesion site with a more stable and uniform force. In this way, by setting the first balloon 231, not only can the cutting segment 221 be prevented from sliding ineffectively or converging due to insufficient radial support, but it can also prevent the cutting segment 221 from being ejected too quickly onto the normal blood vessel wall and causing unnecessary damage. In addition, the first balloon 231 can be inflated by adjusting the pressure of the injected gas or liquid according to the nature of the lesion and the needs of the surgery. This provides the operator with considerable operating space during interventional surgery, allowing them to assess the lesion response at any time and adjust the cutting force of the cutting segment 221 accordingly.

[0086] Further, please refer to Figures 1 to 9In one specific embodiment of the cutting mechanism provided by the present invention, there are multiple cutting wires 22 arranged sequentially along the circumference of the inner tube 11; the cutting segments 221 on the multiple cutting wires 22 are arranged sequentially around the first balloon 231. Thus, when the first balloon 231 expands, it can push multiple cutting segments 221 to move radially outwards from the inner tube 11 for cutting. By arranging multiple cutting wires 22 sequentially around the first balloon 231, multiple cutting wires 22 can cut simultaneously at multiple points, significantly improving cutting efficiency and coverage. Furthermore, the increased number of cutting wires 22 provides the device with higher redundancy; if one cutting wire 22 deforms or wears during operation, the remaining cutting wires 22 can still maintain high working efficiency, thus improving overall safety. Furthermore, arranging multiple cutting wires 22 around the first balloon 231 provides more space for applications such as drug coatings or special surface treatments. Operators can implement different functions on different cutting wires 22, such as creating a notched cutting surface on a specific cutting wire 22, or designing a sustained-release drug on another cutting wire 22 to inhibit restenosis. In one embodiment, multiple cutting wires 22 are evenly distributed around the first balloon 231. After the first balloon 231 is inflated, the cutting wires 22 can simultaneously expand radially outwards and adhere closely to the calcified lesion wall, forming multi-point force application. During this process, the load on each cutting wire 22 is relatively reduced, but the overall combined force is significantly enhanced. This avoids vascular damage that may be caused by excessive stress at a single point and also provides more comprehensive coverage of the lesion area, improving the integrity and efficiency of the cutting.

[0087] Further, please refer to Figures 1 to 9 In one specific embodiment of the cutting mechanism provided by the present invention, multiple cutting segments 221 are arranged to form a chamber 24, and a first balloon 231 is located within the chamber 24. Thus, when the first balloon 231 inflates, it can push the multiple cutting segments 221 radially outward from the inner tube 11 for cutting. Furthermore, the structure of the chamber 24 provides a relatively closed and stable space, allowing the first balloon 231 to be uniformly constrained by the multiple cutting wires 22 during inflating, preventing the first balloon 231 from expanding or protruding in a single direction, thereby reducing the deformation and loss of control problems that are common with traditional first balloons 231. Additionally, as the first balloon 231 gradually fills the chamber 24, it will simultaneously push the cutting segments 221 surrounding it outward, achieving a multi-point, multi-directional, and synchronous cutting action, which is beneficial for efficient cutting of circumferential or locally calcified, stubborn areas. In addition, the expansion of the first balloon 231 after being surrounded by multiple cutting segments 221 is relatively more balanced, which can also make the cutting force form a more consistent pressure coverage on the lesion. In extremely stubborn calcified lesions, the operator can gradually increase the pressure of the first balloon 231, so that multiple cutting wires 22 can act on the lesion surface at the same time for progressive cutting, thereby reducing the risk of vascular tearing caused by applying too much pressure at once.

[0088] Further, please refer to Figures 1 to 9 In one specific embodiment of the cutting mechanism provided by the present invention, the chamber 24 surrounds the outer side of the inner tube 11. Thus, the first balloon 231 can be housed within the chamber 24 surrounding the inner tube 11. Furthermore, when the first balloon 231 within the chamber 24 begins to inflate, it applies a uniform radial thrust to the multiple circumferentially distributed cutting segments 221, achieving 360-degree multi-directional cutting of the calcified lesion. Additionally, the inner tube 11 can be provided with multi-point support and cutting by means of the surrounding first balloon 231. Moreover, this surrounding layout of the first balloon 231 also facilitates storage after lesion cutting; once cutting is complete, the user can deflate (or drain) the first balloon 231 and retract it to a position flush with the inner tube 11.

[0089] Further, please refer to Figures 1 to 9As a specific embodiment of the cutting mechanism provided by the present invention, any two adjacent cutting segments 221 are spaced apart in the circumferential direction of the inner tube 11. Thus, when two adjacent cutting segments 221 move radially outward from the inner tube 11 and cut the occlusion 4, the adjacent cutting segments 221 can cut the occlusion 4 at mutually spaced positions. Furthermore, the spaced-out arrangement of the cutting segments 221 avoids friction, entanglement, or mutual interference between them, allowing each segment to bear force independently and distribute stress evenly. This reduces the risk of breakage or deformation of a single cutting segment 221 due to excessive stress concentration, enhancing the overall stability of the device. Additionally, because the cutting segments 221 are circumferentially spaced, after the device is positioned within the blood vessel, each cutting segment 221 can relatively independently conform to the lesion surface, which is particularly crucial when dealing with calcified plaques of varying shapes and irregular positions. Furthermore, the spaced-out cutting segments 221 design allows for a more effective "multi-point force" effect, improving the cutting efficiency of high-hardness plaques while avoiding unnecessary excessive pressure or damage to normal vascular tissue. This spaced-out cutting segment layout also facilitates smoother coordination with the first balloon 231. When the first balloon 231 inflates within the chamber 24, each cutting segment 221 is pushed outward synchronously and independently in the circumferential direction, avoiding local constriction or uneven deformation caused by the segments being tightly packed together. Because the cutting segments 221 maintain a clear interval, the first balloon 231 can push them more flexibly, adjusting the local pressure according to the hardness and shape differences of the lesion site, achieving a more uniform and thorough cutting action. Furthermore, the spaced cutting segments 221 facilitate easy retraction back into the inner side of the outer tube 12 after surgery. Even if slight deformation differences occur among the cutting segments 221 during retrieval, they will not become entangled and hinder the smooth withdrawal of the instrument, thus enhancing the safety and convenience of the operation. In addition, the spaced cutting segments 221 provide greater flexibility in clinical use. Doctors can flexibly select the number or distribution pattern of the cutting segments 221 according to the severity and location of the lesion to adapt to the lesion characteristics of different patients and improve the effectiveness of personalized treatment.

[0090] Further, please refer to Figures 1 to 9In one specific embodiment of the cutting mechanism provided by the present invention, the outer tube 12 has a channel 121 extending along the length of the outer tube 12; one end of the cutting wire 22 is connected to the inner tube 11, and the other end of the cutting wire 22 is located in the channel 121 and extends along the channel 121. Thus, part of the cutting wire 22 can be housed within the channel 121. Furthermore, the presence of the channel 121 allows the cutting wire 22 to be completely or partially housed within the outer tube 12 when not cutting. The channel 121 acts as a protective channel, thereby greatly reducing the risk of blood vessel wall abrasion or accidental contact with calcified plaques caused by the exposed cutting wire 22 during the delivery process. Furthermore, the channel 121 greatly facilitates the cutting action of the cutting wire 22: after confirming that the instrument has successfully reached the target lesion area, the operator can gradually extend the cutting wire 22 from the channel 121 and expose it at the calcified plaque by relative sliding or pushing. Once the cutting is completed, the cutting wire 22 can be pulled back into the channel 121 for quick retraction. Additionally, because the cutting wire 22 is transported along the channel 121, even if the cutting wire 22 undergoes a certain degree of bending or slight deformation, it will not become entangled or stuck during transport, greatly improving the smoothness of the interventional procedure. Moreover, the channel 121 formed inside the outer tube 12 allows different cutting wires 22 to be laid out along their own independent paths, avoiding interference between multiple cutting wires 22. Furthermore, this channel 121 structure also facilitates maintenance and cleaning, allowing for easier inspection and treatment of tissue fragments or blood clots inside the channel 121 post-operatively, thereby reducing the risk of infection and malfunction during instrument reuse.

[0091] Further, please refer to Figures 1 to 9In one specific embodiment of the cutting mechanism provided by this invention, the number of channels 121 corresponds one-to-one with the number of cutting wires 22. Thus, different cutting wires 22 are housed in different channels 121, allowing for independent and precise storage and release of each wire. This enhances the adaptability and safety of the entire instrument system in challenging surgical scenarios, preventing compression, entanglement, and blockage caused by multiple cutting wires 22 sharing the same or a limited number of channels 121. Furthermore, the one-to-one correspondence between channels 121 and cutting wires 22 ensures that each cutting wire 22 has its own dedicated channel, allowing it to extend or retract individually as needed, and even enabling independent cutting operations in stages or batches within the same procedure. This is particularly flexible when dealing with severely calcified lesions with varied morphologies and complex distributions: the surgeon can first release some cutting wires 22 to cut localized calcifications, then retract and release another portion of the cutting wires 22 to treat the remaining lesion area, thereby minimizing interference or secondary damage to normal blood vessel segments. In addition, the one-to-one correspondence between the channel 121 and the cutting wire 22 allows for differentiated configuration of different cutting wires 22 when necessary. For example, cutting wires 22 with specific markings or drug grooves 222 can be placed in designated channels 121, and the corresponding cutting wire 22 can be released first for cutting or drug release during surgery. After the surgery is completed, the cutting wires 22 of other channels 121 can be activated.

[0092] Further, please refer to Figures 1 to 9 As a specific embodiment of the cutting mechanism provided by the present invention, a drug groove 222 is provided on the surface of the cutting wire 22, and the drug groove 222 is filled with a drug layer 223. Thus, when the cutting wire 22 cuts the occlusion 4, the drug in the drug groove 222 can be applied to the occlusion 4; this ingenious combination of mechanical cutting and drug therapy greatly expands the function and clinical value of this cutting mechanism. For severe calcified stenosis lesions, although simple mechanical cutting can effectively break up calcified plaques, postoperative thrombosis, vascular intima repair, and prevention of restenosis remain challenges that must be faced clinically. By setting a drug groove 222 on the cutting wire 22 and filling it with drug, the drug can be applied to the local blood vessel simultaneously during the cutting process, achieving the dual therapeutic effect of "cutting and administering drugs simultaneously." Furthermore, the design of the drug groove 222 ensures that the drug is distributed more evenly and persistently on the surface of the cutting wire 22, preventing it from being carried away over a large area by a short period of blood flow, thereby achieving continuous release over a certain period of time. This not only improves the local bioavailability of the drug, but also reduces the side effects or systemic burden caused by systemic administration.

[0093] Further, please refer to Figures 1 to 9In one specific embodiment of the cutting mechanism provided by the present invention, the drug reservoir 222 extends along the length of the cutting wire 22. This allows the drug to be released onto the occlusion 4 along the cutting wire 22. Furthermore, by extending the drug reservoir 222 along the entire longitudinal direction of the cutting wire 22, it ensures that the drug is continuously and uniformly delivered to the corresponding site regardless of how the cutting wire 22 bends within the blood vessel or contacts the lesion surface. Additionally, this longitudinal extension allows the cutting wire 22 to exert a drug effect on a larger area of ​​the vascular intima or plaque surface while mechanically breaking up the plaque. Moreover, the close fit between the drug reservoir 222 and the cutting wire 22 itself facilitates cleaning or replacement of the drug layer 223 during recycling or reuse. For scenarios requiring single-use or enhanced use, the drug layer of the cutting wire 22 can be flexibly customized according to preoperative needs.

[0094] Further, please refer to Figures 1 to 9 In one specific embodiment of the cutting mechanism provided by the present invention, one end of the cutting wire 22 connected to the inner tube 11 is connected to the drilling component 21. Thus, after drilling is completed, the cutting wire 22 can enter the through hole along with the drilling component 21. Furthermore, a stable mechanical connection is achieved between the drilling component 21 and the cutting wire 22, allowing the cutting wire 22 to transmit power more directly and fully during advancement or cutting, avoiding energy loss or weak cutting due to loose connection. Especially for severely calcified lesions, this powerful transmission pathway improves cutting efficiency, allowing the cutting wire 22 to break up hard plaques faster and more effectively. In addition, fixing one end of the cutting wire 22 to the drilling component 21 helps maintain the stable trajectory of the cutting wire 22 during its introduction into the blood vessel, reducing adverse events such as deviation, knotting, or entanglement of the cutting wire 22 within the blood vessel, thereby avoiding unnecessary risks of blood vessel wall friction or tearing. In addition, since the drilling component 21 is located at the front end of the inner tube 11, its integrated layout with the cutting wire 22 allows the operator to use the drilling component 21 to first enter and initially penetrate the calcified area, and then use the cutting wire 22 to make more flexible and precise cuts.

[0095] Further, please refer to Figures 1 to 9In one specific embodiment of the cutting mechanism provided by the present invention, the surface of the cutting wire 22 is smoothly connected to the surface of the drilling component 21. Thus, objects within the blood vessel 5 transition along the surface of the drilling component 21 to the surface of the cutting wire 22. Furthermore, the smooth connection between the surfaces of the cutting wire 22 and the drilling component 21 ensures that during the insertion into the blood vessel, the junction between the cutting wire 22 and the drilling component 21 will not cause scraping or pressure on the intima or other normal tissues due to uneven local edges, significantly reducing the risk of accidental wounds and endothelial damage. Additionally, the smooth connection between the surfaces of the cutting wire 22 and the drilling component 21 enhances the structural strength and stability between them, preventing potential loosening, cracks, or gaps that harbor dirt. This helps extend the lifespan of the instrument and facilitates cleaning and disinfection after operation or before reuse, reducing the risk of infection or instrument failure. Moreover, because the cutting wire 22 and the drilling component 21 form a continuous smooth surface, the cutting or drilling action is smoother when encountering hard calcified plaques, reducing energy waste caused by "jamming" at the junction and improving cutting efficiency. In addition, the smooth connection between the cutting wire 22 and the drilling part 21 creates a better adhesion environment for any possible drug coatings or surface nano-treatments, reducing drug detachment or uneven coverage caused by burrs at the joint.

[0096] Further, please refer to Figures 1 to 9In one specific embodiment of the cutting mechanism provided by this invention, the drilling component 21 and the cutting wire 22 are integrated into one piece. This results in a tighter connection between the drilling component 21 and the cutting wire 22. Furthermore, the integrated structure of the drilling component 21 and the cutting wire 22 eliminates potential problems in traditional component-based designs, such as loose connections, loose threads, and fatigue fractures at joints, significantly reducing the risk of having to stop the operation due to accidental separation or loosening. Especially when dealing with severely calcified lesions requiring high-intensity cutting or drilling force, the integrated structure ensures the integrity of energy transfer, preventing energy loss due to friction or misalignment at the connection points, thereby achieving faster fragmentation and removal of calcified plaques. Furthermore, this integrated drilling component 21 and cutting wire 22 simplifies the instrument's manufacturing process and maintenance requirements to some extent: During manufacturing, because the components are formed in the same mold or process, the fit between parts is high and the error is minimal, facilitating mass production and ensuring product consistency; during maintenance, since the drilling component 21 and cutting wire 22 are no longer separate units, medical personnel can more easily check the integrity of the overall structure before and after use, reducing the risk of dirt accumulating at the joints, thus lowering the possibility of bacterial growth or instrument damage. Additionally, the integrated drilling component 21 and cutting wire 22 allow doctors to focus on positioning and cutting itself when dealing with extremely difficult calcified plaques, without worrying about loosening or reduced cutting power, improving operational stability and efficiency.

[0097] Further, please refer to Figures 1 to 9 As a specific embodiment of the cutting mechanism provided by the present invention, the drilling component 21 is rod-shaped and extends along the axial direction of the inner tube 11. This makes drilling very convenient; since the axial direction of the drilling component 21 and the inner tube 11 is the same, the inner tube 11 can be easily guided to move along the through hole after the drilling component 21 has been machined. Furthermore, the rod-shaped drilling component 21 has good rigidity and bending resistance in the axial direction. When there is significant resistance in the blood vessel (e.g., passing through a stubborn calcified segment) or when it is narrow and tortuous, the drilling component 21 can still maintain a stable forward direction, avoiding deflection, twisting, or accidental bending. In addition, the drilling component 21, extending along the axial direction of the inner tube 11, also facilitates docking with an external operating handle or transmission mechanism. Stable thrust and torque can be applied to the drilling component 21 through a single axial sliding or rotation, simplifying the operation process, reducing the excessive requirements for the operator's professional skills, and improving the feasibility of widespread application. In addition, the rod-shaped drilled part 21 is more convenient for cleaning and visual inspection in the later stages of clinical use. Medical staff can rinse, inspect and maintain the drilled part 21 along its axis, find and remove residual debris or dirt in time, and avoid safety hazards when reused.

[0098] Further, please refer to Figures 1 to 9 As a specific embodiment of the cutting mechanism provided by the present invention, the inner tube 11 has a guidewire channel extending along the inner tube 11. Thus, an external guidewire can pass through the guidewire channel to guide the inner tube 11. Furthermore, the presence of the guidewire channel allows the surgeon to pre-deliver the guidewire to the deepest part of the lesion before or during surgery, providing a clear and reliable track for the subsequent cutting mechanism. By sliding or fixing the cutting device on the guidewire, the operator can significantly reduce the positional errors and time costs associated with blindly searching and repeatedly adjusting within the blood vessel, not only reducing surgical complexity but also significantly reducing repeated impacts and compression on the vessel wall. In addition, the guidewire channel design allows the guidewire and the cutting mechanism to coexist independently. If the guidewire needs to be replaced or its position readjusted during surgery, it can be done independently while ensuring the cutting mechanism remains stable, and vice versa, thereby improving the efficiency of responding to emergencies.

[0099] Further, please refer to Figures 1 to 9 As a specific embodiment of the cutting mechanism provided by the present invention, the drilling member 21 has an output hole communicating with the guide wire channel. Thus, the external guide wire can be conveyed along the inner tube 11 and extend to the outside of the drilling member 21 through the output hole, guiding the movement of the drilling member 21. Furthermore, the output hole communicating with the guide wire channel allows for a highly cooperative relationship between the drilling member 21 and the guide wire, enabling the operator to achieve more flexible path planning. Specifically, the physician can first use the guide wire to penetrate the lesion area for positioning, exploration, or tentative unblocking, and after confirming that the channel is relatively unobstructed, precisely insert the cutting mechanism, including the drilling member 21, along the guide wire. In addition, the output hole in the drilling member 21 not only facilitates the entry and exit of the guide wire but also provides an additional channel for subsequent possible flushing, drug infusion, or aspiration operations. Clinically, this output port can also be used to precisely deliver the required liquid if you want to clean up tiny fragments from lesions or inject visualization contrast agents, avoiding the problems of debris accumulation or unclear observation during the cutting process.

[0100] Further, please refer to Figures 10 to 23As a specific embodiment of the cutting mechanism provided by the present invention, a different pushing structure is provided, which includes: a hollow hole 122 opened on the outer tube 12; the cutting wire 22 is an integral piece made of elastic material; when the outer tube 12 moves to a predetermined position relative to the inner tube 11, the cutting segment 221 can pass through the hollow hole 122 and extend to the outside of the outer tube 12 under the elastic force of the cutting wire 22 itself. Thus, when the outer tube 12 moves relative to the inner tube 11 to the predetermined position, the cutting segment 221 can pass through the hollow hole 122 and extend to the outside of the outer tube 12 under the elastic force of the cutting wire 22 (i.e., the cutting wire 22 is in an elastic bending state when it is retracted into the outer tube 12, and when the outer tube 12 moves relative to the inner tube 11 and the hollow hole 122 reaches the cutting segment 221, the cutting segment 221 can restore its own shape and extend to the outside of the outer tube 12). When the cutting segment 221 reaches the outside of the outer tube 12, it can cut the blockage 4 on the outside of the outer tube 12; when the outer tube 12 moves relative to the inner tube 11 and leaves the predetermined position, the cutting segment 221 is retracted into the outer tube 12 along with the inner tube 11.

[0101] In one embodiment, the cavity inside the inner tube 11 can be used for guidewire passage or as a liquid infusion channel (e.g., for infusing saline solution). In another embodiment, the gap between the inner tube 11 and the outer tube 12 can be used as a liquid infusion channel (e.g., for infusing saline solution).

[0102] Further, please refer to Figures 10 to 23 As a specific embodiment of the cutting mechanism provided by the present invention, the inner tube 11 includes: a front section tube 111 and a rear section tube 112 extending along a predetermined axis L and coaxially arranged; the front section tube 111 and the rear section tube 112 are spaced apart; the edge of the front section tube 111 near the rear section tube 112 is a first annular edge, and the edge of the rear section tube 112 near the front section tube 111 is a second annular edge; one end of the cutting wire 22 is connected to the first annular edge, and the other end of the cutting wire 22 is connected to the second annular edge. Thus, the cutting wire 22 can connect the front section tube 111 and the rear section tube 112. Furthermore, this segmented tube design of the front section tube 111 and the rear section tube 112 allows the cutting mechanism to have a certain degree of variability in length, providing more adaptability for handling calcified lesions of different lengths or multiple segments. Furthermore, one end of the cutting wire 22 is connected to the first annular edge, and the other end is connected to the second annular edge. When force is applied, the cutting wire 22 can more smoothly distribute energy to the front section tube 111 and the rear section tube 112, avoiding problems such as stress concentration, twisting, or even breakage that may occur in traditional single-tube structures. In addition, this "double-sided fixing" method also makes the process of retrieving and deploying the cutting wire 22 more versatile. Users can pull the rear section tube 112 through the front section tube 111, and users can also pull the front section tube 111 through the rear section tube 112.

[0103] Further, please refer to Figures 24 to 27 As a specific embodiment of the cutting mechanism provided by the present invention, the pushing structure further includes: a second balloon 232; a receiving space 113 located on a predetermined axis L is provided between the front tube 111 and the rear tube 112, the second balloon 232 is located in the receiving space 113, and the cutting segment 221 of the cutting wire 22 is located on the expansion path of the second balloon 232. Thus, the front tube 111 and the rear tube 112 are connected by the cutting wire 22; when the second balloon 232 in the receiving space 113 expands, the second balloon 232 will push the cutting segment 221 to move radially outward towards the predetermined axis L, so that the cutting segment 221 can pass through the hollow hole 122 on the outer tube 12; in addition, during the process of the cutting segment 221 moving away from the predetermined axis L, it can cut the blockage 4 on the radially outer side of the inner tube 11. Furthermore, by introducing a second balloon 232 and placing it within the space between the anterior tube 111 and the posterior tube 112, the second balloon 232 can provide sufficient radial support for the cutting wire 22 to effectively break up hard calcified plaques. Additionally, the presence of the second balloon 232 prevents the cutting wire 22 from collapsing or shifting due to lack of effective support during the cutting action. Moreover, for different patients with different vessel diameters or lesion lengths, physicians can control the extension range and force of the cutting wire 22 by adjusting the inflation level of the second balloon 232, performing strong cutting in highly calcified areas and appropriately reducing balloon pressure in thinner lesion areas to reduce the risk of vessel wall damage. Furthermore, when it is time to end the cutting or prepare to withdraw the instrument, the operator can deflate (or drain) the second balloon 232, allowing the cutting wire 22 to gradually return to a converging state, significantly reducing the outer diameter of the instrument and lowering the probability of secondary scraping or pinching during withdrawal or retraction.

[0104] Further, please refer to Figures 10 to 23 As a specific embodiment of the cutting mechanism provided by the present invention, the number of cutting wires 22 is multiple; the multiple cutting wires 22 are arranged in parallel with each other, such as... Figure 15-21 As shown; or multiple cutting wires 22 intersecting each other, such as Figure 22-23As shown. Thus, the parallel or intersecting cutting wires 22 enhance each other's mechanical strength for easier cutting. Furthermore, arranging multiple cutting wires 22 in parallel allows for simultaneous entry or multi-point dispersed cutting on the same vessel cross-section, making it particularly suitable for rapid fragmentation of annular or semi-annular calcifications. The parallel arrangement of the cutting wires 22 also ensures that the forces acting on each cutting wire 22 are relatively independent, preventing the efficiency of other wires from being affected by temporary jamming of one wire, thereby improving the overall treatment speed for multiple stenosis or long lesions. Additionally, when multiple cutting wires 22 are arranged in a crisscross pattern, the mesh or twisting force formed at the intersections can generate a stronger mutual anchoring effect, applying multidirectional tearing and shearing effects to the plaque surface, thereby more rapidly breaking down hard deposits. In one embodiment, for stubborn areas that are difficult to remove in one go, the operator can also precisely break down the most rigid part of the lesion by applying time-sharing or force-sharing adjustments to different cutting wires 22, reducing the risk of pulling or damaging surrounding normal tissue. Furthermore, the multiple cutting wires 22 provide the instrument with a higher tolerance for error during clinical operation: if one cutting wire 22 is damaged or broken during use, the other wires can still continue to work, preventing the entire device from failing completely. Additionally, this multi-cutting wire 22 architecture provides greater flexibility for applications with drug delivery systems or special coatings, allowing different types or dosages of drugs to be loaded onto certain cutting wires 22 according to surgical needs, combining mechanical cutting with pharmacological intervention.

[0105] Further, please refer to Figures 10 to 23 In one specific embodiment of the cutting mechanism provided by the present invention, each cutting wire 22 extends along a predetermined axis L. Thus, the stress on the cutting wire 22 can extend along the predetermined axis L. Furthermore, for the cutting wires 22 extending along the predetermined axis L, when the operator advances the device along the blood vessel direction, these cutting wires 22 can cut into or grind calcified plaques in the most direct and approximately straight manner, reducing lateral friction between the cutting wires 22 and the blood vessel wall, and facilitating high-speed and efficient cutting in longer or relatively straight lesion areas.

[0106] In one embodiment, the angle between the extension direction of each cutting wire 22 and the predetermined axis L is greater than zero. Thus, the stress transmission direction of the cutting wire 22 has an inclined angle with the predetermined axis L, allowing the cutting wire 22 to guide stress radially outward towards the predetermined axis L. Furthermore, by setting the cutting wires 22 at an angle to the predetermined axis L, these inclined cutting wires 22 can perform a complex cutting action of twisting, pulling, and shearing on calcified plaques from different angles when entering tortuous or multi-segmented narrow blood vessels. Additionally, the inclined distribution of the cutting wires 22 can generate stronger rotary cutting or lateral traction forces on the plaque surface, facilitating the removal of hard deposits. Moreover, even if one cutting wire 22 is overloaded or worn, the other cutting wires 22 in different directions can still maintain overall cutting efficiency.

[0107] Further, please refer to Figures 10 to 23 In one specific embodiment of the cutting mechanism provided by the present invention, each cutting wire 22 is wavy. Thus, the wavy cutting wire 22 has stronger tensile or bending capabilities, facilitating its stretching and retraction. Furthermore, the wavy structure can create multiple undulations on the cutting wire 22, with each peak or trough potentially becoming a tiny "cutting tooth." When contacting hard calcified plaques, these teeth can achieve a highly concentrated stress impact on a point-to-area basis, assisting in more quickly breaking down or cutting through the deposits. In addition, the wavy design greatly improves the elastic reserve and bending resistance of the cutting wire 22. When the device is advanced through complex or curved blood vessel segments, the wavy cutting wire 22 can deform moderately within its own elastic range, maintaining a closer fit to the curvature of the blood vessel. This not only helps reduce pressure on the normal blood vessel wall but also concentrates the cutting force more effectively on the lesion area. In addition, from a clinical safety perspective, the wave-like structure can absorb some of the impact force when encountering unexpected resistance or high-intensity plaques through the segmented deformation of its own crests, reducing the risk of the cutting wire 22 or the blood vessel wall breaking or tearing due to excessive instantaneous load.

[0108] Further, please refer to Figures 10 to 23As a specific embodiment of the cutting mechanism provided by the present invention, the drilling element 21 is disposed at the front edge of the front section tube 111, and the drilling element 21 is serrated perpendicular to or at an angle to the predetermined axis L. Thus, the serrated drilling element 21 more easily cuts the blockage 4 within the blood vessel 5. Furthermore, when facing hard plaques, the serrated drilling element 21 can quickly "bite" or "saw" the lesion surface, and its multiple cutting edges can form point-to-point high-stress contact with the calcifications. When the instrument is advanced within the blood vessel, the serrated shape effectively resists the sliding and rebound of the plaque surface, thereby converting more propulsion force into fragmentation or cutting efficiency. In addition, before the cutting wire 22 is fully deployed, the drilling element 21 partially loosens or pre-fractures the stubborn calcifications, allowing the subsequent cutting wire 22 to more easily enter and further fragment the lesion core, shortening the operation time and reducing repeated compression of the blood vessel wall. Furthermore, the serrated drill bit 21 can work in conjunction with the second balloon 232 or other propulsion mechanisms. When greater cutting force is required, the operator can slightly rotate or press to make the serrated tips perform a "reciprocating sawing" motion on the plaque, which improves fragmentation efficiency and reduces the impact of a single large-scale compression on the vascular intima. Additionally, for old plaques with layered calcification or strong adhesion, the serrated drill bit 21 can often penetrate the surface hard shell more quickly, providing more operating space for the cutting wire 22. Moreover, the multi-point contact of the serrated drill bit 21 also has a certain self-positioning effect, making it less prone to lateral slippage when continuous thrust is applied, thus avoiding the risk of instrument displacement or rupture of the vessel wall in narrow blood vessels. In one embodiment, the serrated drill bit 21 is combined with high-frequency vibration or ultrasonic vibration, so that each tip on the serrations can become an energy focusing point, further enhancing fragmentation performance.

[0109] Further, please refer to Figures 10 to 23In one specific embodiment of the cutting mechanism provided by this invention, the drilling component 21 and the front tube 111 are integrated. This provides a stronger mechanical connection between the drilling component 21 and the inner tube 11. Furthermore, the integrated drilling component 21 and the front tube 111 completely eliminate common potential defects such as loosening, misalignment, and seam breakage. When subjected to high-intensity, prolonged pushing, pulling, or rotating operations, there will be no sudden detachment or localized damage due to weak connections. Additionally, for situations requiring the breakthrough of severely calcified or multi-segmented stubborn plaques, the integrated drilling component 21 and the front tube 111 can form a more stable and reliable force transmission path, transmitting the force applied by the operator completely and efficiently to the plaque surface, thereby achieving rapid and stable penetration and fragmentation. Moreover, this integration also reduces, to some extent, the abrupt changes in the shape of the local structure caused by the addition of other connecting components, ensuring lower external contour resistance during intravascular delivery. When the device travels along a tortuous or narrow blood vessel, the integrated drilled part 21 and the front tube 111 are not easily jammed by intimal protrusions, nor are they prone to scratching or local pressure concentration caused by protrusions of other connectors, thereby further reducing the probability of accidental injury or device jamming.

[0110] Further, please refer to Figures 10 to 23 As a specific embodiment of the cutting mechanism provided by the present invention, there are multiple perforated holes 122; the number of perforated holes 122 corresponds one-to-one with the number of cutting wires 22. Thus, the cutting segments 221 on the cutting wires 22 can extend from the corresponding perforated holes 122 to the outside of the outer tube 12, allowing the cutting segments 221 to cut the blockage 4 from different positions. Furthermore, each cutting wire 22 can independently enter and exit through a specific perforated hole 122, minimizing physical interference between them and significantly reducing the probability of entanglement or force interference during use. Additionally, this one-to-one correspondence allows the operator to more flexibly release and store different cutting wires 22 in stages or segments during surgery. Moreover, when these perforated holes 122 are evenly distributed around the circumference of the outer tube, each cutting wire 22, with the cooperation of the second balloon 232 or the pushing structure, can form a more balanced circumferential support and cut the blood vessel wall, reducing to some extent the situation of "excessive force in a certain direction leading to localized damage to the blood vessel." In addition, this one-to-one design facilitates postoperative cleaning, inspection and reuse: targeted channel inspection can quickly determine whether a cutting wire 22 or channel is damaged or has foreign objects left behind, and also reduces the risk of cross-infection when reused.

[0111] Please see Figures 1 to 9The present invention also provides an ultrasonic cutting device, comprising: an ultrasonic generator 3 having a transmission ring 31 and a cutting mechanism; the transmission ring 31 is ultrasonically connected to a drilling element 21 and a cutting wire 22 respectively (ultrasonic connection: ultrasonic connection between two components means that ultrasonic waves can be transmitted between the two components). Thus, the transmission ring 31 can transmit ultrasonic waves to the drilling element 21 and the cutting wire 22, allowing the drilling element 21 and the cutting wire 22 to vibrate at high frequency, greatly improving the cutting ability of the drilling element 21 and the cutting wire 22; due to the above-mentioned cutting mechanism, the outer tube 12 is sleeved outside the inner tube 11, and the outer tube 12 can slide relative to the inner tube 11 along the inner tube 11; the inner tube 11 can be housed inside the outer tube 12, and the outer tube 12 and the inner tube 11 can enter the blood vessel 5 together; the front end of the inner tube 11 is provided with a drilling element 21, and when the outer tube 12... When the inner tube 11 is moved relative to the inner tube 11 to expose the drilling element 21, the user can directly (or indirectly) push the inner tube 11 to drill a hole in the occlusion 4 within the blood vessel 5 through the drilling element 21; the inner tube 11 is provided with a cutting wire 22, which can be housed in the outer tube 12 along with the inner tube 11; the cutting wire 22 has a cutting section 221, which is located behind the drilling element 21; after drilling is completed, a through hole is machined in the occlusion 4, and the cutting wire 22 can continue to move forward with the inner tube 11 into the through hole; when the cutting wire 22... After the cutting segment 221 enters the through hole, the outer tube 12 is slidable so that the cutting segment 221 of the cutting wire 22 can be exposed from the outer tube 12. The pushing structure 23 can move the cutting segment 221 radially outward from the inner tube 11 (that is, under the pushing of the pushing structure 23, the cutting segment 221 can move radially along the inner tube 11 and gradually move away from the inner tube 11) to cut the inner wall of the through hole on the plug 4. After the cutting segment 221 cuts the inner wall of the through hole on the plug 4, the plug 4 can be further cleaned. In summary: for narrow holes with hard texture The lesion blockage 4 is drilled through the drilling component 21 behind the cutting wire 22, as the cutting segment 221 of the cutting wire 22 is located behind the drilling component 21. The drilling component 21 first drills a through hole in the blockage 4 in the blood vessel 5. After the blockage 4 is drilled through the hole, its own structure is also destroyed, which facilitates the subsequent cleaning of the blockage 4. When the cutting segment 221 on the cutting wire 22 enters the through hole, the cutting segment 221 can cut the inner wall of the through hole under the push of the pushing structure 23. The cutting segment 221 can cut the blockage 4 from the inside to the outside, which facilitates the further cleaning and opening of the blockage 4.

[0112] In one embodiment, the ultrasonic generator 3 includes a transmission ring 31, a transducer 32, and an amplitude transformer 33, wherein the transducer 32 is connected to the transmission ring 31 via the amplitude transformer 33.

[0113] In one embodiment, the ultrasonic generator 3 further includes: a main unit 34; the main unit 34 is capable of controlling the transducer 32; the control process of the main unit 34 over the transducer 32 is as follows: the main unit 34 continuously provides a stable and compatible high-frequency electrical signal to the transducer 32, and monitors and adjusts its working state in real time; the transducer 32 is capable of converting the high-frequency electrical signal into mechanical vibration. In one embodiment, the main unit 34 includes: a power supply, a control panel, and an ultrasonic generating unit. In one embodiment, the power supply mainly provides a stable power supply. The control panel includes a display screen, buttons, and knobs for setting and monitoring operating parameters, such as power and frequency. The ultrasonic generating unit mainly generates high-frequency electrical signals.

[0114] In one embodiment, regarding transducer 32: it converts high-frequency electrical signals into high-frequency vibrational mechanical energy. In one embodiment, transducer 32 is the core component of ultrasonic generator 3, responsible for converting electrical energy into mechanical vibrational energy. Commonly used ultrasonic transducers 32 are mostly made of piezoelectric ceramic materials. When transducer 32 receives a high-frequency electrical signal from a power source, the piezoelectric ceramic generates an inverse piezoelectric effect, that is, mechanical deformation occurs under the action of an electric field, forming high-frequency mechanical vibration, converting electrical energy into ultrasonic vibrational energy. In one embodiment, piezoelectric transducer 32 consists of a piezoelectric ceramic sheet, front and rear metal cover plates, and pre-tightening bolts. The ceramic sheet is mechanically pre-tightened to generate a stress state, improving the stability and efficiency of vibration. The vibration frequency depends on the shape, thickness, and material properties of the ceramic sheet. The mechanical vibration output by transducer 32 is axial vibration, which is coupled to the subsequent amplitude transformer 33 or tool head through the end face of transducer 32 to achieve energy transfer. The energy conversion efficiency of the transducer 32 is highest when it operates at its resonant frequency. Therefore, the size and structure of the transducer 32 are usually precisely calculated in the design to ensure that it operates in the resonant state.

[0115] In one embodiment, regarding the amplitude transformer 33: The amplitude transformer 33, also known as an amplitude converter, is a mechanical component connecting the transducer 32 and the tool head. Its function is to amplify the ultrasonic vibration amplitude output by the transducer 32 to meet processing requirements. Typically, the amplitude generated by the transducer 32 is relatively small (several micrometers to tens of micrometers), insufficient for direct application in processing scenarios. Therefore, the amplitude transformer 33 amplifies the vibration amplitude through its special geometric structure. In one embodiment, the amplitude transformer 33 adopts a stepped, conical, or exponential structural design. This gradual change in shape effectively increases the vibration amplitude. In the amplitude transformer 33, according to the principle of mechanical vibration, the gradually decreasing cross-sectional area amplifies the vibration velocity and amplitude. The amplitude transformer 33 is made of a high-strength and highly elastic alloy material, such as titanium alloy, aluminum alloy, or stainless steel, to withstand the fatigue stress generated by high-frequency vibration. The amplitude transformer 33 not only amplifies the amplitude but also plays a role in matching mechanical impedance and optimizing energy transfer.

[0116] In one embodiment, the transfer ring 31 transmits the high-frequency vibration mechanical energy converted by the transducer 32 and is connected to the transducer 32 and the inner tube 11. In one embodiment, the transfer ring 31 is mainly used in the ultrasonic system for the effective transmission and mechanical connection of mechanical vibration, playing a role in fixation, coupling, and impedance matching. The transfer ring 31 is located between the transducer 32 and the amplitude transformer 33 or tool head, and its function is to ensure that the energy loss of ultrasonic vibration is minimized during transmission and that the vibration is reliably transmitted to the processing tool. In one embodiment, the ultrasonic energy output by the transducer 32 needs to be transmitted through a multi-stage structure, and the mechanical connection between the components is particularly critical. The transfer ring 31 is precision machined to ensure tight contact between the transducer 32 and the amplitude transformer 33, avoiding vibration energy loss at the interface. In one embodiment, the transfer ring 31 also further optimizes the mechanical impedance matching and improves the efficiency of the overall system through material selection and shape design. In one embodiment, the material of the transfer ring 31 is high-strength alloy steel or titanium alloy, and the surface is specially treated to improve wear resistance and fatigue resistance, thereby extending the service life and stability of the entire system.

[0117] In one embodiment, regarding the power supply, the power supply is the energy providing device in the ultrasonic generator 3 system. Its main function is to convert ordinary AC mains power into a high-frequency alternating current signal after rectification and filtering, and to precisely control the output frequency and amplitude. Ultrasonic processing requires a high-frequency power supply with stable frequency and controllable amplitude to ensure that the transducer 32 obtains stable and efficient vibration energy. In one embodiment, the power supply includes a rectifier circuit, an oscillation circuit, a power amplifier circuit, and an automatic frequency tracking circuit. The rectifier circuit converts AC power into DC power, and the oscillation circuit generates a high-frequency signal at a specific frequency. After passing through the power amplifier circuit, the power and amplitude of the signal are significantly improved, thereby meeting the driving requirements of the transducer 32. In one embodiment, the power supply in the ultrasonic generator 3 also has the function of automatically tracking the resonant frequency of the transducer 32, ensuring that it always operates in the optimal resonance state, improving energy conversion efficiency and equipment lifespan. Therefore, the power supply plays an important role in energy conversion and stable output in the entire ultrasonic system.

[0118] Further, please refer to Figures 1 to 9As a specific embodiment of the ultrasonic cutting instrument provided by the present invention, it further includes: a tube seat 13 and a telescopic elastic tube 14; the tube seat 13 is sleeved on the outside of the inner tube 11, and the tube seat 13 is located behind the outer tube 12, with the tube seat 13 and the outer tube 12 spaced apart front and back; the telescopic elastic tube 14 is sleeved on the outside of the inner tube 11, and the telescopic elastic tube 14 is located between the tube seat 13 and the outer tube 12; the outer tube 12 is connected to the tube seat 13 through the telescopic elastic tube 14; a transfer ring 31 is disposed on the tube seat 13. Thus, the outer tube 12 can telescopically move relative to the tube seat 13 through the telescopic elastic tube 14. In addition, the arrangement of the tube seat 13 facilitates the placement and fixation of the transfer ring 31. Since the transfer ring 31 is a key point for the collection and coupling of ultrasonic energy, a space is formed between the transfer ring 31 and the outer tube 12 to avoid the transfer ring 31 being too close to the interventional part inside the blood vessel, thereby reducing the impact on the blood vessel. Furthermore, the tube seat 13 is located behind the outer tube 12 with a certain gap between them. This provides a safer and more reliable placement area for the transfer ring 31, facilitating adjustments to the parameters of the ultrasound generator 3 by medical personnel before or during surgery. It also facilitates debugging and upgrades, such as replacing the ultrasound module with one of higher frequency or different power. Additionally, the telescopic elastic tube 14 provides a degree of mobility to the outer tube 12. When the operator needs to move the outer tube 12 forward or backward or make minor angle adjustments to align the drill bit 21 or cutting wire 22 with a specific lesion, the telescopic elastic tube 14 can accommodate this movement through the elasticity or corrugated structure of its material. Moreover, the layout of the tube seat 13 and the telescopic elastic tube 14 makes it easier for maintenance and operation personnel to disassemble or replace the corresponding components. If wear or aging is detected in the telescopic elastic tube 14 during or after surgery, only the tube needs to be replaced locally without interfering with the overall function of the outer tube 12, inner tube 11, or even the core ultrasound components. In addition, the transfer ring 31 located on the tube seat 13 can more securely connect to the ultrasound generator, which not only ensures the efficient coupling of ultrasound energy, but also allows doctors to maintain the overall stability of the instrument during operations such as cutting and rinsing.

[0119] Further, please refer to Figures 1 to 9As a specific embodiment of the ultrasonic cutting instrument provided by the present invention, it also includes a movable switch 15 disposed on the outer tube 12. Thus, the user can move the outer tube 12 by using the movable switch 15. Furthermore, the presence of the movable switch 15 allows the user to flexibly control the back-and-forth sliding of the outer tube 12 without relying on excessive auxiliary tools, helping physicians to complete the positioning or fine-tuning of the outer tube 12 in the shortest possible time, allowing operation with the hand in the same posture, preventing increased error rates due to frequent changes in grip posture. In addition, when combined with scales or markings, the movable switch 15 allows operators to more intuitively grasp the displacement of the outer tube 12 relative to the inner tube 11, so as to obtain consistent results in repeated operations or multi-stage cutting. For example, in complex calcified lesions, physicians may need to slowly move the outer tube 12 forward multiple times, each time moving a fixed distance to fragment the plaque in stages; in this case, the movable switch 15 can help to implement precise control. In addition, the movable switch 15 can also be set to either a "working" or "safe" position. When the movable switch 15 is in the "safe" position, the cutting wire 22 is inside the outer tube 12; when the movable switch 15 is in the "working" position, the cutting wire 22 protrudes outside the outer tube 12. This prevents the cutting wire 22 from accidentally popping out of the outer tube 12 and piercing normal tissue, which is of positive significance in preventing operational errors. Furthermore, this external mechanism of the movable switch 15 is easy to disassemble or upgrade independently without requiring significant modifications to the entire outer tube 12 and tube seat system, thus minimizing the cost and risk during the instrument improvement process.

[0120] Please see Figures 1 to 9The present invention also provides an ultrasonic cutting catheter, comprising: an ultrasonic cutting instrument. Thus, by employing the aforementioned ultrasonic cutting instrument, the transmission ring 31 can transmit ultrasonic waves to the drilling element 21 and the cutting wire 22, enabling the drilling element 21 and the cutting wire 22 to undergo ultrasonic vibration, greatly improving the cutting ability of the drilling element 21 and the cutting wire 22; due to the aforementioned cutting mechanism, the outer tube 12 is sleeved outside the inner tube 11, and the outer tube 12 can slide relative to the inner tube 11 along the inner tube 11; the inner tube 11 can be housed inside the outer tube 12, and the outer tube 12 and the inner tube 11 can enter the blood vessel 5 together; the front end of the inner tube 11 is provided with a drill... When the outer tube 12 moves relative to the inner tube 11 to expose the drilling component 21, the user can directly (or indirectly) push the inner tube 11 to drill a hole in the blockage 4 within the blood vessel 5 through the drilling component 21. A cutting wire 22 is provided on the inner tube 11, which can be retracted into the outer tube 12 along with the inner tube 11. The cutting wire 22 has a cutting section 221 located behind the drilling component 21. After drilling is completed, a through hole is formed in the blockage 4, and the cutting wire 22 can continue to move forward with the inner tube 11 into the through hole. When the cutting wire 22 is cut... After the cutting segment 221 on the cutting wire 22 enters the through hole, the outer tube 12 is slid to allow the cutting segment 221 of the cutting wire 22 to protrude from the outer tube 12. The pushing structure 23 can move the cutting segment 221 radially outward from the inner tube 11 (that is, under the pushing of the pushing structure 23, the cutting segment 221 can move radially along the inner tube 11 and gradually move away from the inner tube 11) to cut the inner wall of the through hole on the plug 4. After the cutting segment 221 cuts the inner wall of the through hole on the plug 4, the plug 4 can be further cleaned. In summary: for materials with a hard texture The stenotic lesion occluder 4 is blocked by the cutting section 221 of the cutting wire 22, which is located behind the drilling component 21. The drilling component 21 first drills a through hole in the occluder 4 in the blood vessel 5. After the occluder 4 is drilled through the hole, its own structure is also destroyed, which makes it easier to clean the occluder 4 in the future. When the cutting section 221 on the cutting wire 22 enters the through hole, the cutting section 221 can cut the inner wall of the through hole under the push of the pushing structure 23. The cutting section 221 can cut the occluder 4 from the inside to the outside, which makes it easier to clean and open the occluder 4.

[0121] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and substitutions can be made without departing from the technical principles of the present invention, and these improvements and substitutions should also be considered within the scope of protection of the present invention.

Claims

1. A cutting mechanism, characterized in that, include: Inner tube; Outer tube; the outer tube is sleeved on the outside of the inner tube, and the outer tube can slide relative to the inner tube in the front-back direction; A drilling component; the drilling component is disposed at the front end of the inner tube; Cutting wire; The cutting wire is disposed on the inner tube, and the cutting wire has a cutting section; the cutting section is located behind the drilling component; the cutting wire can be housed in the outer tube along with the inner tube or extend out of the outer tube. A pushing structure; the pushing structure is used to push the cutting segment to move radially outward from the inner tube; The outer tube has a channel that extends along the length of the outer tube; one end of the cutting wire is connected to the inner tube, and the other end of the cutting wire is located in the channel and extends along the channel; the number of channels corresponds one-to-one with the number of cutting wires. When not cutting, the cutting wire can be completely or partially housed within the outer tube, with each cutting wire laid out along its own independent path; the cutting wire can gradually extend out of the channel along with the inner tube.

2. The cutting mechanism as described in claim 1, characterized in that, The propulsion structure includes: a first balloon disposed on the inner tube; the cutting segment located radially outside the inner tube; and the first balloon located between the inner tube and the cutting segment.

3. The cutting mechanism as described in claim 2, characterized in that, The number of cutting wires is multiple, and the multiple cutting wires are arranged sequentially along the circumference of the inner tube; the cutting segments on the multiple cutting wires are arranged sequentially around the first balloon.

4. The cutting mechanism as described in claim 3, characterized in that, Multiple cut segments are arranged together to form a chamber, and the first balloon is located inside the chamber; the chamber surrounds the outside of the inner tube; any two adjacent cut segments are spaced apart in the circumferential direction of the inner tube.

5. The cutting mechanism as described in claim 1, characterized in that, The surface of the cutting wire is provided with drug grooves, and the drug grooves are filled with a drug layer; the drug grooves extend along the length direction of the cutting wire.

6. The cutting mechanism as described in claim 1, characterized in that, One end of the cutting wire connected to the inner tube is connected to the drilling component; the surface of the cutting wire is smoothly connected to the surface of the drilling component; the drilling component and the cutting wire are an integral part.

7. The cutting mechanism as described in claim 1, characterized in that, The drilling component is rod-shaped and extends along the axial direction of the inner tube.

8. The cutting mechanism as described in claim 1, characterized in that, The inner tube has a guide wire channel; the guide wire channel extends along the inner tube; the drilling component has an output hole communicating with the guide wire channel.

9. The cutting mechanism as described in claim 1, characterized in that, The pushing structure includes: a hollow hole opened on the outer tube; the cutting wire is an integral piece made of elastic material; when the outer tube moves to a predetermined position relative to the inner tube, the cutting segment can pass through the hollow hole and extend to the outside of the outer tube under the elastic force of the cutting wire itself.

10. The cutting mechanism as described in claim 9, characterized in that, The inner tube includes a front section tube and a rear section tube that extend along a predetermined axis and are coaxially arranged; the front section tube and the rear section tube are spaced apart from each other; the edge of the front section tube near the rear section tube is a first annular edge, and the edge of the rear section tube near the front section tube is a second annular edge; one end of the cutting wire is connected to the first annular edge, and the other end of the cutting wire is connected to the second annular edge.

11. The cutting mechanism as described in claim 10, characterized in that, The propulsion structure further includes: a second balloon; there is an accommodating space between the front tube and the rear tube located on the predetermined axis, the second balloon is located within the accommodating space, and the cutting segment of the cutting wire is located on the expansion path of the second balloon.

12. The cutting mechanism as described in claim 10, characterized in that, The number of cutting wires is multiple; the multiple cutting wires are arranged in parallel to each other, or the multiple cutting wires are arranged in a cross shape.

13. The cutting mechanism as described in claim 12, characterized in that, Each of the cutting wires extends along the predetermined axis, or the angle between the extension direction of each of the cutting wires and the predetermined axis is greater than zero.

14. The cutting mechanism as described in claim 12, characterized in that, Each of the cutting wires is wavy.

15. The cutting mechanism as described in claim 10, characterized in that, The drilling component is disposed at the front end edge of the front section tube, and the drilling component is serrated perpendicular to or at an angle to the predetermined axis; the drilling component and the front section tube are integral parts; there are multiple hollow holes; the number of hollow holes corresponds one-to-one with the number of cutting wires.

16. The cutting mechanism according to any one of claims 1 to 15, characterized in that, The cutting wire is a one-piece component made of flexible material.

17. An ultrasonic cutting instrument, characterized in that, include: An ultrasonic generator having a transfer ring and a cutting mechanism as described in any one of claims 1 to 16; the transfer ring is ultrasonically connected to the drilling component and the cutting wire, respectively.

18. The ultrasonic cutting instrument as described in claim 17, characterized in that, Also includes: A tube seat and a telescopic elastic tube; the tube seat is sleeved on the outside of the inner tube, the tube seat is located behind the outer tube, and the tube seat and the outer tube are spaced apart front and back; the telescopic elastic tube is sleeved on the outside of the inner tube, and the telescopic elastic tube is located between the tube seat and the outer tube; the outer tube is connected to the tube seat through the telescopic elastic tube; the transfer ring is disposed on the tube seat; It also includes: a movable switch installed on the outer tube.

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