Cutting system

Abstract

The application relates to a cutting system, which comprises a handle, a sheath, an inner tube, a cutter assembly and an operating member. The interior of the handle is defined as a cavity, and a cleaning port is arranged on the outer shell of the handle and communicates with the cavity. The proximal end of the sheath is connected with the handle and communicates with the cavity. The inner tube is movably arranged in the sheath and the cavity, and the proximal end of the inner tube is connected with the operating member. The distal end of the inner tube is connected with the cutter assembly. The operating member can move along the axial direction of the inner tube relative to the handle, and drives the cutter assembly to move between a first position and a second position by driving the inner tube to move. In the first position, at least part of the cutter assembly is located outside the distal end of the sheath. In the second position, the cutter assembly is located in the cavity and is arranged opposite to the cleaning port. According to the cutting system, multiple valve sections can be continuously removed under the premise of avoiding the escape of valve fragments, and the efficiency of removing the valve is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a cutting system. Background Technology

[0002] Interventional therapy is a rapidly developing emerging discipline that integrates imaging diagnosis and clinical treatment. It has become one of the three pillars of clinical medicine, alongside traditional internal medicine and surgery. Valve resection systems primarily target the removal of valves. Interventional therapy offers advantages such as being minimally invasive, simple to operate, having definite efficacy, and being repeatable, making it a promising direction for the diagnosis and treatment of vascular diseases. As an instrument used in interventional procedures, valve resection systems can quickly remove valves. The veins removed from the valves can then be used as arterial bypass vessels, finding wide application in bypass and interventional procedures for arterial occlusive diseases.

[0003] In existing minimally invasive surgery, a valve scalpel is used to rupture the valve using barbs on its tip. However, the ruptured valve fragments may escape and enter the artery, potentially causing serious consequences such as cardiac arrest or cerebral hypoxia. If multiple valves exist in the same segment of the blood vessel being treated, during surgery requiring the removal of multiple valves, to prevent the escape of valve fragments, the sheath along with the valve scalpel and the shredded valve must be withdrawn from the body after each segment is removed. The cleaned cutting system or a new cutting system is then reinserted at the target location to continue removing other valves in that segment of the blood vessel. This process is repeated until multiple valve segments are removed. The repeated intervention and withdrawal of the cutting system leads to low valve removal efficiency, severely impacting the surgeon's progress and causing excessive harm to the patient. Summary of the Invention

[0004] The purpose of this invention is to at least solve the problem of low efficiency in clearing valve fragments using existing valve knives, which affects the surgical process. To address the shortcomings of the prior art, a cutting system is provided.

[0005] The technical problem solved by this invention is achieved through the following technical solution:

[0006] This invention provides a cutting system comprising a handle, a sheath, an inner tube, a cutting blade assembly, and an operating element. The handle defines a cavity, and the handle housing has a cleaning port communicating with the cavity. The proximal end of the sheath is connected to the handle and communicates with the cavity. The inner tube is movably inserted through the sheath and the cavity, and the proximal end of the inner tube is connected to the operating element. The distal end of the inner tube is connected to the cutting blade assembly. The operating element is axially movable relative to the handle along the inner tube and drives the cutting blade assembly to move between a first position and a second position by driving the inner tube to move. In the first position, at least a portion of the cutting blade assembly is located outside the distal end of the sheath. In the second position, the cutting blade assembly is located within the cavity and is positioned opposite the cleaning port.

[0007] In some embodiments of the present invention, the cutting system further includes a fixing seat, which is fixedly disposed inside the sheath and located at the distal end of the sheath; the cutting assembly includes a first cutting blade and a second cutting blade disposed opposite to each other along the axial direction of the inner tube, the first cutting blade being connected to the distal end of the inner tube, the second cutting blade being movably sleeved outside the inner tube and detachably connected to the fixing seat, the second cutting blade and the fixing seat having a connected state and a disassembled state, in the connected state, the second cutting blade and the fixing seat being fixedly opposite to each other along the axial direction of the inner tube, in the disassembled state, the second cutting blade being movable relative to the fixing seat along the axial direction of the inner tube.

[0008] In some embodiments of the present invention, the cutting system further includes a pulling assembly movably inserted into the sheath and the cavity. The fixing seat includes a fixing part and a clamping part. The fixing part is connected to the inner wall of the sheath. The distal end of the clamping part is connected to the proximal end of the fixing part. The proximal end of the clamping part is connected to the distal end of the pulling assembly. Under the pulling action of the pulling assembly, the clamping part can elastically deform along the radial direction of the inner tube between a contracted state and an extended state. In the connected state, the clamping part is in the contracted state, and the inner diameter of the clamping part is smaller than the outer diameter of the second cutter, thus clamping and fixing the second cutter. In the disassembled state, the clamping part is in the extended state, and the inner diameter of the clamping part is larger than the outer diameter of the second cutter.

[0009] In some embodiments of the present invention, the cutting system further includes a pull button, which is disposed on the handle in a manner movable along the axial direction; the clamping portion includes a plurality of jaws arranged sequentially at intervals along the circumference of the inner tube; the pulling assembly includes a first pulling ring, a pulling wire, a second pulling ring, and an elastic component connected sequentially from the proximal end to the distal end; the first pulling ring is located within the cavity and connected to the pull button; the elastic component includes a plurality of first elastic elements, the distal end of each first elastic element being connected to the proximal end of one of the jaws.

[0010] In some embodiments of the present invention, the cutting system further includes a positioning button and a positioning rod, the surface of the second cutter is provided with a groove, one end of the positioning rod is used to insert into the groove for fixing the second cutter in the second position, and the other end of the positioning rod is located outside the cavity and connected to the positioning button.

[0011] In some embodiments of the present invention, the first cutter has a first cutting edge portion disposed toward the proximal end, and the second cutter has a second cutting edge portion disposed toward the distal end, wherein the first cutting edge portion can engage with the second cutting edge portion to cut tissue.

[0012] In some embodiments of the present invention, the first cutter has a first inner cavity, the proximal end of the first inner cavity forms a first opening, the first cutting edge is disposed around the first opening, and when the second cutting edge engages with the first cutting edge, the second cutter closes the first opening; and / or, the second cutter has a second inner cavity, the distal end of the second inner cavity forms a second opening, the second cutting edge is disposed around the second opening, and when the first cutting edge engages with the second cutting edge, the first cutter closes the second opening.

[0013] In some embodiments of the present invention, at least one of the first cutter and the second cutter is a magnetic element, and the first cutter and the second cutter can be magnetically connected; or, the cutting system further includes a flexible connector, the proximal end of which is connected to the second cutter, and the distal end of which is connected to the first cutter. When the flexible connector is extended along the axial direction, the first cutter and the second cutter are spaced apart along the axial direction.

[0014] In some embodiments of the present invention, the cutting system further includes a push rod, a TIP head, and a push button. The TIP head is located on one side of the distal end of the sheath and is detachably connected to the distal end of the sheath. The push rod is movably inserted into the inner tube, and the distal end of the push rod is connected to the TIP head. The inner tube is provided with a clearance notch. The push button is axially movable on the handle and passes through the clearance notch to be connected to the proximal end of the push rod.

[0015] In some embodiments of the present invention, the proximal end face of the TIP head is provided with a receiving groove, and the first cutter is detachably disposed in the receiving groove.

[0016] According to the above-mentioned cutting system, after the cutting blade assembly cuts the valve, the cutting blade assembly along with the cut valve or valve fragments is retracted into the sheath through the operating device and the inner tube, and the cutting blade assembly is moved proximally to the second position, that is, the cleaning port position of the cavity. The valve or valve fragments are removed through the cleaning port. Then, the cutting blade assembly is pushed to the first position, that is, the distal end of the sheath, through the operating device and the inner tube, so as to further cut other valves in the same segment of the blood vessel. Under the premise of avoiding the escape of valve fragments, multiple valve segments can be continuously removed, thereby improving the valve removal efficiency. Attached Figure Description

[0017] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. Wherein:

[0018] Figure 1 This is a schematic diagram of a cutting system according to an embodiment of the present invention, where the cutter assembly is in a first position and the first cutter and the second cutter are engaged.

[0019] Figure 2 This is a schematic diagram of the cutting system from another perspective when the cutter assembly is in the first position and the first cutter and the second cutter are engaged, according to an embodiment of the present invention.

[0020] Figure 3 This is a schematic diagram of the cutting system from another perspective when the cutter assembly is in the first position according to an embodiment of the present invention;

[0021] Figure 4 This is a schematic diagram of a cutting system according to an embodiment of the present invention, where the cutter assembly is in a first position and the first cutter and the second cutter are separated.

[0022] Figure 5 This is a schematic diagram of the cutting system when the cutter assembly is in the second position according to an embodiment of the present invention;

[0023] Figure 6 This is a cross-sectional structural diagram of a cutting system when the cutter assembly is in the first position according to an embodiment of the present invention.

[0024] Figure 7 for Figure 6 A magnified view of part A in the middle;

[0025] Figure 8for Figure 6 Schematic diagram of the cross-sectional structure of the middle BB section;

[0026] Figure 9 for Figure 8 A magnified view of part C in the middle;

[0027] Figure 10 for Figure 6 A partial cross-sectional view of the middle handle section;

[0028] Figure 11 This is a partial cross-sectional structural diagram of the sheath, fixing seat, second cutter and pulling assembly in the connected state according to an embodiment of the present invention;

[0029] Figure 12 This is a partial cross-sectional structural diagram of the sheath, fixing seat, second cutter and pulling assembly in a disassembled state according to an embodiment of the present invention;

[0030] Figure 13 This is a cross-sectional structural diagram of a TIP head, push rod, inner tube, and first cutter according to an embodiment of the present invention;

[0031] Figure 14 This is a cross-sectional structural diagram of the first cutter, the flexible connector, and the second cutter according to an embodiment of the present invention;

[0032] Figure 15 This is a cross-sectional structural diagram of the sheath, fixing base, and second cutter according to an embodiment of the present invention;

[0033] Figure 16 This is a cross-sectional structural diagram of the sheath, fixing seat, and second cutter according to another embodiment of the present invention.

[0034] The labels in the attached diagram are as follows:

[0035] 100. Cutting system;

[0036] 10. Handle; 11. Cavity; 111. Cleaning port;

[0037] 20. Sheath; 30. Inner tube; 31. Clearance notch;

[0038] 40. Cutting blade assembly; 41. First cutting blade; 411. First body; 412. First blade edge; 413. First connecting part; 414. First inner cavity; 4141. First opening; 42. Second cutting blade; 421. Second body; 422. Second blade edge; 423. Second connecting part; 424. Second inner cavity; 4241. Second opening; 425. Protrusion; 426. Second stepped surface;

[0039] 50. Operating component; 60. Fixed base; 61. Fixing part; 611. Slot; 612. First step surface; 62. Clamping part; 621. Gripper;

[0040] 71. Pulling assembly; 711. First pull ring; 712. Pulling wire; 713. Second pull ring; 714. Elastic component; 7141. First elastic element; 72. Pulling button;

[0041] 74. Positioning button; 75. Positioning rod; 751. Boss; 76. Second elastic element; 77. Flexible connector;

[0042] 81. Push rod; 82. Tip head; 821. Receiving groove; 83. Push button; 101. Receiving gap; 420. Groove. Detailed Implementation

[0043] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0044] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0045] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0046] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure rotates, then an element described as "below other elements or features" or "below other elements or features" will subsequently be oriented "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations.

[0047] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the center of the distal and proximal ends of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0048] The cutting system 100 in this embodiment of the invention can be used to cut valves, plaque tissue on the inner wall of blood vessels, thrombus tissue within blood vessels, etc. The following embodiment describes a cutting system for cutting valves.

[0049] Please combine Figure 1 , Figure 2 , Figure 5 and Figure 7 As shown, this embodiment proposes a cutting system 100, which includes a handle 10, a sheath 20, an inner tube 30, a cutting blade assembly 40, and an operating component 50. The handle 10 defines a cavity 11 inside, and the outer shell of the handle 10 is provided with a cleaning port 111 communicating with the cavity 11. The proximal end of the sheath 20 is connected to the handle 10 and communicates with the cavity 11. The inner tube 30 is movably inserted into the sheath 20 and the cavity 11, and the proximal end of the inner tube 30 is connected to the operating component. The operating element 50 is detachably located at the proximal end of the handle 10. The operating element 50 can move axially relative to the handle 10 along the inner tube 30, thereby driving the inner tube 30 to move axially relative to the sheath 20 and the handle 10. The distal end of the inner tube 30 is connected to the cutter assembly 40. During the axial movement of the inner tube 30, the cutter assembly 40 is driven to move axially, so that the cutter assembly 40 can move between a first position and a second position under the pulling or pushing of the operating element 50 and the inner tube 30.

[0050] When the cutting assembly 40 is in the first position, at least a portion of the cutting assembly 40 is located outside the distal end of the sheath 20. That is, the cutting assembly 40 can extend beyond the distal end of the sheath 20 under the action of the inner tube 30, and complete the valve resection through the relative movement between the cutting assembly 40 and the valve. After the valve resection is completed, the cutting assembly 40 can also move proximally under the action of the inner tube 30, so that the cutting assembly 40 and the cut valve fragments can be collected inside the sheath 20, completing the retrieval of the cutting assembly 40 and the valve fragments. Under the action of the operating member 50 and the inner tube 30, it continues to move proximally until the cutting assembly 40 moves to the second position. When the cutting assembly 40 is in the second position, the cutting assembly 40 is located in the cavity 11 and is positioned opposite to the cleaning port 111, so that the valve or valve fragments can be removed using the cleaning port 111. After the valve fragments are cleared, the cutting assembly 40 is pushed to the first position, i.e. the distal end of the sheath 20, using the operating member 50 and the inner tube 30, so as to further cut other valves in the same segment of the blood vessel. This allows the cutting system 100 proposed in this invention to continuously complete the resection of multiple valve segments without escaping valve fragments, thereby improving the valve resection efficiency.

[0051] In this embodiment, please refer to Figure 6 , Figure 7 , Figure 11 and Figure 12 As shown, the cutting system 100 also includes a fixing seat 60, which is located inside the sheath tube 20 and fixedly connected to the inner wall of the sheath tube 20. The fixing seat 60 is located at the distal end of the sheath tube 20, and the distal end of the fixing seat 60 is flush with the distal end of the sheath tube 20. The fixing seat 60 has a tubular structure, and its outer peripheral surface is fixedly connected to the inner wall surface of the sheath tube 20 by bonding. The cutting blade assembly 40 includes a first cutting blade 41 and a second cutting blade 42. The first cutting blade 41 is connected to the distal end of the inner tube 30 and is movably sleeved on the outside of the inner tube 30. The second cutting blade 42 is detachably connected to the fixing seat 60. The first cutting blade 41 and the second cutting blade 42 are arranged opposite to each other in the axial direction of the inner tube 30. The second cutting blade 42 has a connected state and a detached state with the fixing seat 60. When the second cutter 42 is connected to the fixed base 60, the operating member 50 and the inner tube 30 drive the first cutter 41 to move axially relative to the sheath 20, causing the first cutter 41 and the second cutter 42 to move relative to each other in the axial direction. This allows the first cutter 41 and the second cutter 42 to engage and cut the valve. The outer diameters of both the first cutter 41 and the second cutter 42 are smaller than the inner diameter of the fixed base 60. When the second cutter 42 is detached from the fixed base 60, the first cutter 41 and the second cutter 42 can move through the fixed base 60 into the sheath 20 under the influence of the inner tube 30, and continue to move proximally into the cavity 11 of the handle 10 to facilitate the removal of the cut valve fragments.

[0052] In other embodiments, the distal end of the fixing seat 60 extends beyond the distal end of the sheath 20, or the distal end of the fixing seat 60 is disposed within the sheath 20.

[0053] It should be noted that when the cutting assembly 40 is in the first position, the first cutting blade 41 is located outside the distal end of the sheath 20, the proximal portion of the second cutting blade 42 is fixed to the fixing seat 60 and located inside the sheath 20, and the distal portion of the second cutting blade 42 is located outside the sheath 20. The distal portion of the second cutting blade 42 can cooperate with the first cutting blade 41 to remove the valve.

[0054] The second cutter 42 and the fixed base 60 can be detachably connected according to various structural forms, so that the second cutter 42 and the fixed base 60 can switch between connected and detached states.

[0055] For example, in some embodiments, please combine Figure 2 , Figure 5 and Figure 15 As shown, the inner wall of the fixing base 60 is provided with a groove 611, and the outer peripheral surface of the second cutter 42 is provided with a protrusion 425 that engages with the groove 611. The groove 611 is configured as an annular groove extending circumferentially around the fixing base 60, and the inner wall contour of the groove 611 is arc-shaped and smoothly transitions to the inner wall of the fixing base 60. The contour of the protrusion 425 matches the inner wall contour of the groove 611. In the connected state, the protrusion 425 is located in the groove 611, so that the second cutter 42 engages with the fixing base 60. Through the cooperation between the protrusion 425 and the groove 611, the second cutter 42 can withstand a certain range of axial pressure. When the first cutter 41 and the second cutter 42 cooperate to cut the valve, it is ensured that the second cutter 42 and the fixing base 60 remain relatively stationary. After the valve is cut, the first cutter 41 is pulled towards the proximal end by the operating member 50 and the inner tube 30. The first cutter 41 applies a large thrust to the second cutter 42. When the thrust is large and exceeds the axial pressure that the second cutter 42 can withstand, the protrusion 425 disengages from the slot 611, thereby separating the second cutter 42 from the fixing seat 60, and switching the second cutter 42 from the fixing seat 60 from the connected state to the disassembled state.

[0056] In other embodiments, such as Figure 16As shown, to prevent the second cutter 42 from dislodging from the distal end of the fixing base 60 into the sheath 20, the inner hole of the fixing base 60 is configured as a stepped hole with a first stepped surface 612 facing the proximal end. The outer peripheral surface contour of the second cutter 42 matches the inner hole of the fixing base 60, forming a second stepped surface 426 facing the distal end on the outer peripheral surface of the second cutter 42. In the connected state, the second stepped surface 426 abuts against the first stepped surface 612, preventing the second cutter 42 from continuing to move relative to the distal end of the fixing base 60 and avoiding the second cutter 42 from dislodging from the sheath 20. In this embodiment, the assembly method of the second cutter 42 and the fixing base 60 in the sheath 20 can be: after radially compressing the second cutter 42, it is inserted into the fixing base 60 from the distal end of the sheath 20. In this embodiment, please refer to Figure 14 As shown, the first cutter 41 and the second cutter 42 are connected by a flexible connector 77. As the first cutter 41 moves to the far end under the drive of the inner tube 30, the flexible connector 77 pulls the second cutter 42 from the second position to the first position until the second cutter 42 is engaged with the fixed seat 60.

[0057] In other embodiments, the second cutter 42 and the fixing base 60 can also be magnetically connected to achieve a detachable connection. For example, at least one of the fixing base 60 and the second cutter 42 is configured as a magnetic element, and the fixing base 60 and the second cutter 42 are magnetically connected. In the magnetically connected state, the magnetic attraction between the fixing base 60 and the second cutter 42 enables the second cutter 42 to withstand a certain range of axial pressure. When the first cutter 41 and the second cutter 42 cooperate to cut the valve, it is ensured that the second cutter 42 and the fixing base 60 remain relatively stationary. After the valve cutting is completed, the operating member 50 and the inner tube 30 pull the first cutter 41 towards the proximal end, and the first cutter 41 applies a large thrust to the second cutter 42. When the thrust is large and exceeds the magnetic attraction force, the second cutter 42 separates from the fixing base 60, thereby switching the second cutter 42 and the fixing base 60 from the connected state to the detached state.

[0058] In other embodiments, the second cutter 42 and the fixed base 60 can also be detachably connected by a threaded connection. The inner wall of the fixed base 60 is provided with an internal thread (not shown in the figure), and the outer peripheral surface of the second cutter 42 is provided with an external thread (not shown in the figure). The fixed base 60 and the second cutter 42 are threadedly connected. In this embodiment, at least one of the first cutter 41 and the second cutter 42 is a magnetic component. The first cutter 41 and the second cutter 42 can be magnetically connected. By rotating the operating member 50, the operating member 50 drives the inner tube 30 and the first cutter 41 to rotate, and then uses the first cutter 41 to drive the second cutter 42 to rotate, so that the second cutter 42 can rotate relative to the fixed base 60. At the same time, by pushing the operating member 50 to move axially, the operating member 50 drives the inner tube 30 and the first cutter 41 to move axially relative to the fixed base 60, and then uses the first cutter 41 to drive the second cutter 42 to move axially relative to the fixed base 60. That is, the operating member 50 can control the rotation and axial movement of the second cutter 42 relative to the fixed base 60, thereby realizing the switching between the fixed base 60 and the second cutter 42 in the connected state and the disassembled state.

[0059] In some embodiments, please combine Figure 11 and Figure 12 As shown, the fixing seat 60 includes a fixing part 61 and a clamping part 62. The fixing part 61 has a cylindrical structure and is fixedly disposed inside the sheath tube 20. The distal end of the clamping part 62 is connected to the proximal end of the fixing part 61. The cutting system 100 also includes a pulling assembly 71, which is movably disposed within the sheath tube 20 and the cavity 11 and is connected to the proximal end of the clamping part 62. The pulling assembly 71 applies a pulling force in the axial direction toward the proximal end to the clamping part 62 by moving axially relative to the fixing seat 60 within the sheath tube 20, so that the clamping part 62 can elastically deform between a contracted state and an extended state along the radial direction of the inner tube 30 under the pulling action of the pulling assembly 71. In the connected state, the clamping part 62 is in a retracted state, and the inner diameter of the clamping part 62 is smaller than the outer diameter of the second cutter 42, which can clamp and fix the second cutter 42; in the disassembled state, the clamping part 62 is in an extended state, and the inner diameter of the clamping part 62 is larger than the outer diameter of the second cutter 42.

[0060] Specifically, when no external force is applied, the clamping part 62 is in a contracted state, and its outer and inner diameters gradually decrease from the distal to the proximal end. The inner diameter of the clamping part 62 is smaller than the inner diameter of the fixing part 61, and the clamping part 62 can clamp and fix the second cutter 42. The pulling assembly 71 is connected to the proximal end of the clamping part 62. When the pulling assembly 71 moves towards the proximal end and applies a pulling force to the clamping part 62, the pulling force applied by the pulling assembly 71 to the clamping part 62 has a radially outward component. This causes the proximal end of the clamping part 62 to tend to expand and deform radially outward when subjected to the pulling force applied by the pulling assembly 71, increasing the outer and inner diameters of the clamping part 62 until the inner diameter of the clamping part 62 is larger than the outer diameter of the second cutter 42, allowing the second cutter 42 to be released from the fixing seat 60. Therefore, by controlling the traction assembly 71 to move axially relative to the sheath 20 and the fixed seat 60, the second cutter 42 and the fixed seat 60 can be switched between connected and disassembled states.

[0061] Furthermore, please combine Figure 6 , Figure 7 , Figure 11 and Figure 12 As shown, the traction assembly 71 includes a first traction ring 711, a traction wire 712, a second traction ring 713, and an elastic member 714 connected sequentially from the proximal end to the distal end. The cutting system 100 also includes a traction button 72, which is axially movable on the handle 10, allowing the traction button 72 to move axially relative to the handle 10. The clamping part 62 includes a plurality of clamps 621 arranged at intervals along the circumference of the inner tube 30. The elastic member 714 includes a plurality of first elastic elements 7141, and the first traction... Ring 711 is located within cavity 11 and connected to pull button 72. Second pull ring 713 is slidably disposed within sheath 20 and sleeved outside inner tube 30. Pull wire 712 passes through sheath 20 and cavity 11. Proximal end of pull wire 712 is connected to first pull ring 711, and distal end of pull wire 712 is connected to second pull ring 713. Distal end of each first elastic element 7141 is connected to proximal end of a gripper 621, and proximal end of each first elastic element 7141 is connected to distal end of second pull ring 713. By driving pull button 72 to move axially relative to handle 10, each gripper 621 can be driven to move sequentially through first pull ring 711, pull wire 712, second pull ring 713, and gripper 621, so that multiple grippers 621 switch between contracted and extended states.

[0062] In this embodiment, as Figure 11 and Figure 12As shown, the first elastic element 7141 is a helical spring, and the traction assembly 71 includes multiple traction wires 712. The multiple traction wires 712 are arranged sequentially at intervals along the circumferential direction of the sheath tube 20. The two ends of each traction wire 712 are connected to a first traction ring 711 and a second traction ring 713, respectively. The second traction ring 713 has a cylindrical structure and is in clearance fit with the sheath tube 20, so that the second traction ring 713 can slide smoothly along the axial direction within the sheath tube 20. The second traction ring 713 also provides support and limits for each of the first elastic elements 7141, preventing the first elastic elements 7141 from tangling with each other. By limiting the position of the first elastic elements 7141, it ensures that the tension applied by the first elastic elements 7141 to the proximal end of the gripper 621 has a radially outward component, so that the multiple grippers 621 can open radially when subjected to tension. The traction wire 712 has a filamentous structure and good bending performance, which allows the cutting system 100 to better conform to the tortuous structure of the blood vessel during the intervention at the target location, thus reducing the difficulty of the intervention.

[0063] Furthermore, please combine Figure 6 , Figure 10 and Figure 14 As shown, the cutting system 100 also includes a positioning button 74 and a positioning rod 75. The positioning rod 75 is located at or near the cleaning port 111. The handle 10 has a sliding hole communicating with the cavity 11. The positioning rod 75 is slidably inserted into the sliding hole. The surface of the second cutter 42 is provided with a groove 420. One end of the positioning rod 75 is located inside the cavity 11 and is inserted into the groove 420. The other end of the positioning rod 75 is located outside the cavity 11 and is connected to the positioning button 74. Pressing the positioning button 74 drives the positioning rod 75 to insert into the groove 420. The groove 420 and the positioning rod 75 limit the second cutter 42, preventing the second cutter 42 from shifting when cleaning the valve fragments collected in the first inner cavity 414 and the second inner cavity 424 through the cleaning port 111, which would affect the efficiency of cleaning the valve fragments. After the valve cleaning is completed, by pulling the positioning button 74, the positioning rod 75 is separated from the groove 420, releasing the second cutter 42, thereby further moving the second cutter 42 from the second position to the first position for subsequent cutting operations.

[0064] Furthermore, such as Figure 10 As shown, the cutting system 100 also includes a second elastic element 76, which is sleeved on the positioning rod 75. One end of the second elastic element 76 abuts against the handle 10, and the other end abuts against the positioning button 74. The second elastic element 76 is used to apply an elastic force radially outward from the central axis of the handle 10 to the positioning button 74, so that the positioning button 74 can automatically reset, thereby simplifying the operation of locking or unlocking the wire 712. The positioning rod 75 is provided with a boss 751 that mates with the inner wall of the cavity 11 to prevent the positioning rod 75 from falling off the handle 10.

[0065] In some embodiments, please combine Figure 7 , Figure 13 and Figure 14 As shown, the first cutter 41 includes a first connecting portion 413 and a first body 411 connected to the first connecting portion 413. The first body 411 has a tubular structure. The first connecting portion 413 is connected to the distal end of the first body 411. The proximal end of the first body 411 is open, and a first cutting edge portion 412 is provided at the proximal end of the first body 411, which is oriented towards the proximal end. The proximal end of the first cutting edge portion 412 forms the tip of the cutting edge, and the outer diameter of the outer peripheral surface of the first cutting edge portion 412 gradually increases from the proximal end to the distal end. The second cutter 42 includes a second connecting portion 423 and a second body 421 connected to the second connecting portion 423. The second body 421 has a tubular structure. The second connecting portion 423 is connected to the proximal end of the second body 421. The distal end of the second body 421 is open, and a second cutting edge portion 422 is provided at the distal end of the second body 421, facing the distal end. The distal end of the second cutting edge portion 422 forms the tip of the cutting edge, and the outer diameter of the inner wall surface of the second cutting edge portion 422 gradually increases from the proximal end to the distal end. In this embodiment, the outer peripheral surface of the first cutting edge portion 412 engages with the inner wall surface of the second cutting edge portion 422 to cut the valve.

[0066] Furthermore, the first body 411 encloses a first inner cavity 414, and the proximal end of the first body 411 forms a first opening 4141 communicating with the first inner cavity 414. The first blade portion 412 is disposed around the first opening 4141. The second body 421 encloses a second inner cavity 424, and the distal end of the second body 421 forms a second opening 4241 communicating with the second inner cavity 424. The second blade portion 422 is disposed around the second opening 4241. When the first blade portion 412 and the second blade portion 422 engage, the first cutter 41 closes the second opening 4241, and the second cutter 42 closes the first opening 4141, so that the first inner cavity 414 and the second inner cavity 424 together constitute a closed space for accommodating valve fragments.

[0067] In detail, during the valve cutting process, firstly, the first cutter 41 and the second cutter 42 are spaced apart in the axial direction. By adjusting the positions of the first cutter 41 and the second cutter 42 in the vein, the valve to be cut is positioned between the first cutter 41 and the second cutter 42. Then, the inner tube 30 pulls the first cutter 41, causing the first cutter 41 and the second cutter 42 to move towards each other until the first blade 412 and the second blade 422 engage and cut the valve. At the same time, valve fragments are collected. Within the enclosed space formed by the first inner cavity 414 and the second inner cavity 424, the pulling button 72 and the pulling assembly 71 are operated to disassemble the second cutter 42 from the fixing seat 60. Finally, the first cutter 41 is pulled towards the proximal end by the operating member 50 and the inner tube 30. The first cutter 41 pushes the second cutter 42 to move together until the first cutter 41 and the second cutter 42 move to the second position. Then, the valve fragments collected in the first inner cavity 414 and the second inner cavity 424 can be cleaned through the cleaning port 111.

[0068] In this embodiment, by storing the cut valve fragments in the closed space formed by the first inner cavity 414 and the second inner cavity 424, the escape of valve fragments is effectively prevented, and the safety of the operation is improved.

[0069] In some embodiments, after the valve is cut, during the process of resetting the first cutter 41 and the second cutter 42 to the first position, to enable the second cutter 42 to move from the cavity 11 toward the distal end to the position of the fixation seat 60, at least one of the first cutter 41 and the second cutter 42 is a magnetic element, and the first cutter 41 and the second cutter 42 can be magnetically connected. Utilizing the magnetic attraction between the first cutter 41 and the second cutter 42, the first cutter 41 pulls the second cutter 42 toward the distal end. In this embodiment, by utilizing magnetic attraction to reset the second cutter 42, the overall structure of the cutting system 100 is simplified, effectively reducing the structural complexity of the cutting system 100, which is beneficial for reducing production costs and surgical operation difficulty.

[0070] In other embodiments, such as Figure 14As shown, after the valve is cut, during the process of resetting the first cutter 41 and the second cutter 42 to the first position, in order to enable the second cutter 42 to move from the cavity 11 toward the distal end to the position of the fixing seat 60, the cutting system 100 also includes a flexible connector 77. The flexible connector 77 can be configured as a wire-like structure. The proximal end of the flexible connector 77 is connected to the second connecting portion 423 of the second cutter 42, and the distal end of the flexible connector 77 is connected to the first connecting portion 413 of the first cutter 41. The flexible connector 77 extends in the axial direction, and the length L of the flexible connector 77 in the axial direction is greater than the sum of the length L1 of the first cutter 41 in the axial direction and the length L2 of the second cutter 42 in the axial direction, that is, L is greater than L1 + L2. With this configuration, when the flexible connector 77 is extended axially, the first cutter 41 and the second cutter 42 are spaced apart axially, so that the valve can extend between the first blade portion 412 of the first cutter 41 and the second blade portion 422 of the second cutter 42, and then the valve is removed by the engagement of the first blade portion 412 and the second blade portion 422.

[0071] In some embodiments, please combine Figure 1 , Figure 4 , Figure 7 , Figure 8 and Figure 9 As shown, the cutting system 100 also includes a push rod 81, a tip head 82, and a push button 83. The push button 83 is axially movable on the handle 10, allowing the push button 83 to move axially relative to the handle 10. The tip head 82 is located on one side of the distal end of the sheath 20. The push rod 81 is movably inserted into the inner tube 30, with the distal end of the push rod 81 connected to the tip head 82. The inner tube 30 is provided with a clearance notch 31. One end of the push button 83 located in the cavity 11 passes through the clearance notch 31 and is connected to the proximal end of the push rod 81. By driving the push button 83 to move axially relative to the handle 10, the push rod 81 and the tip head 82 can move axially relative to the sheath 20, thereby allowing the tip head 82 and the distal end of the sheath 20 to abut against each other or separate. Understandably, after the valve is cut, the push button 83 is moved towards the proximal side relative to the handle 10, so that the TIP head 82 is connected to the distal end of the sheath 20, so that the TIP head 82 closes the distal opening of the sheath 20, thereby further preventing valve fragments from escaping from the sheath 20 and increasing the safety of the operation.

[0072] Furthermore, please combine Figure 7 and Figure 13As shown, the proximal end face of the TIP head 82 is provided with a receiving groove 821. The first cutter 41 is detachably disposed in the receiving groove 821. When the first cutter 41 is housed in the receiving groove 821, the proximal end of the first blade portion 412 is flush with the proximal end of the TIP head 82. A receiving gap 101 for accommodating the second blade portion 422 is defined between the first blade portion 412 and the inner wall of the receiving groove 821. When the first blade portion 412 and the second blade portion 422 are engaged, the second blade portion 422 is inserted into the receiving gap 101, and the proximal end face of the TIP head 82 abuts against the distal end face of the sheath 20. This arrangement allows the first blade portion 412 and the second blade portion 422 to cut the valve while simultaneously closing the distal end of the sheath 20 with the TIP head 82, further reducing the possibility of valve fragments escaping. In other embodiments, provided that the first cutting edge 412 and the second cutting edge 422 can engage, the proximal end of the first cutting edge 412 may extend beyond the proximal end of the TIP head 82, or the proximal end of the first cutting edge 412 may be located inside the TIP head 82.

[0073] In this embodiment, during the process of the first cutter 41 and the second cutter 42 cutting the valve, the first cutter 41 and the second cutter 42 can be engaged by moving the push button 83 proximally and using the TIP head 82 to push the first cutter 41 proximally. During this process, relative movement between the first cutter 41 and the TIP head 82 can be avoided, thereby ensuring that the first blade 412 and the second blade 422 close the distal end of the sheath 20 with the TIP head 82 while cutting the valve, preventing the cut valve fragments from escaping from the sheath 20 and increasing the safety of the operation.

[0074] In this embodiment, as Figure 3 As shown, the positioning button 74, the traction button 72, and the push button 83 are arranged sequentially and at intervals along the circumferential direction of the handle 10, so that the positioning button 74, the traction button 72, and the push button 83 are respectively arranged on the upper and lower sides and the left and right sides of the handle 10. The operating element 50 is located at the proximal end of the handle 10, so that each functional block can be set separately. On the one hand, this prevents the mutual interference of each button, and on the other hand, it can effectively reduce accidental operation such as accidental touch during the operation and improve the efficiency of the operation.

[0075] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A cutting system, characterized in that, The cutting system includes a handle, a sheath, an inner tube, a cutting blade assembly, and an operating element. The handle defines a cavity, and the outer shell of the handle has a cleaning port communicating with the cavity. The proximal end of the sheath is connected to the handle and communicates with the cavity. The inner tube is movably inserted through the sheath and the cavity, and the proximal end of the inner tube is connected to the operating element. The distal end of the inner tube is connected to the cutting blade assembly. The operating element is axially movable relative to the handle along the inner tube and drives the cutting blade assembly to move between a first position and a second position by driving the inner tube to move. In the first position, at least a portion of the cutting blade assembly is located outside the distal end of the sheath. In the second position, the cutting blade assembly is located within the cavity and is positioned opposite the cleaning port.

2. The cutting system according to claim 1, characterized in that, The cutting system also includes a fixing seat, which is fixedly disposed inside the sheath and located at the distal end of the sheath; The cutting assembly includes a first cutting blade and a second cutting blade arranged opposite to each other along the axial direction of the inner tube. The first cutting blade is connected to the distal end of the inner tube, and the second cutting blade is movably sleeved on the outside of the inner tube and detachably connected to the fixed base. The second cutting blade and the fixed base have a connected state and a disassembled state. In the connected state, the second cutting blade and the fixed base are fixed relative to each other along the axial direction of the inner tube. In the disassembled state, the second cutting blade can move relative to the fixed base along the axial direction of the inner tube.

3. The cutting system according to claim 2, characterized in that, The cutting system further includes a traction assembly, which is movably inserted into the sheath and the cavity. The fixing seat includes a fixing part and a clamping part. The fixing part is connected to the inner wall of the sheath. The distal end of the clamping part is connected to the proximal end of the fixing part. The proximal end of the clamping part is connected to the distal end of the traction assembly. Under the traction action of the traction assembly, the clamping part can elastically deform along the radial direction of the inner tube between a contracted state and an extended state. In the connected state, the clamping part is in the contracted state, and the inner diameter of the clamping part is smaller than the outer diameter of the second cutter, which can clamp and fix the second cutter; in the disassembled state, the clamping part is in the extended state, and the inner diameter of the clamping part is larger than the outer diameter of the second cutter.

4. The cutting system according to claim 3, characterized in that, The cutting system also includes a pull button, which is provided on the handle in a manner that allows it to move along the axial direction, and the clamping part includes a plurality of clamps that are spaced apart sequentially along the circumference of the inner tube; The traction assembly includes a first traction ring, a traction wire, a second traction ring, and an elastic component connected sequentially from the proximal end to the distal end. The first traction ring is located within the cavity and connected to the traction button. The elastic component includes a plurality of first elastic elements, the distal end of each first elastic element being connected to the proximal end of one of the grippers.

5. The cutting system according to claim 4, characterized in that, The cutting system also includes a positioning button and a positioning rod. The surface of the second cutter is provided with a groove. One end of the positioning rod is used to insert into the groove to fix the second cutter in the second position. The other end of the positioning rod is located outside the cavity and is connected to the positioning button.

6. The cutting system according to claim 2, characterized in that, The first cutter has a first cutting edge portion facing the proximal end, and the second cutter has a second cutting edge portion facing the distal end. The first cutting edge portion can engage with the second cutting edge portion to cut tissue.

7. The cutting system according to claim 6, characterized in that, The first cutter has a first inner cavity, and a first opening is formed at the proximal end of the first inner cavity. The first cutting edge is arranged around the first opening. When the second cutting edge engages with the first cutting edge, the second cutter closes the first opening. And / or, the second cutter has a second inner cavity, the distal end of the second inner cavity forms a second opening, the second cutting edge is disposed around the second opening, and when the first cutting edge and the second cutting edge engage, the first cutter closes the second opening.

8. The cutting system according to any one of claims 2 to 7, characterized in that, At least one of the first cutter and the second cutter is a magnetic component, and the first cutter and the second cutter can be magnetically connected; Alternatively, the cutting system may further include a flexible connector, the proximal end of which is connected to the second cutter, and the distal end of which is connected to the first cutter. When the flexible connector is extended along the axial direction, the first cutter and the second cutter are spaced apart along the axial direction.

9. The cutting system according to any one of claims 2 to 7, characterized in that, The cutting system also includes a push rod, a tip head, and a push button. The tip head is located on one side of the distal end of the sheath and is detachably connected to the distal end of the sheath. The push rod is movably inserted into the inner tube, and the distal end of the push rod is connected to the tip head. The inner tube is provided with a clearance notch. The push button is axially movable on the handle and passes through the clearance notch to be connected to the proximal end of the push rod.

10. The cutting system according to claim 9, characterized in that, The proximal end face of the TIP head is provided with a receiving groove, and the first cutter is detachably disposed in the receiving groove.

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