Endoluminal interventional operation device

Abstract

The invention relates to an endocavitary interventional operation device which comprises a first sheath assembly, a second sheath assembly and an umbrella protection assembly, the first sheath assembly comprises a protection umbrella and a first sheath tube, and the protection umbrella is connected to the far end of the first sheath tube; the umbrella protection assembly is detachably connected to the near end of the second sheath assembly, the first sheath tube can axially and movably penetrate through the umbrella protection assembly and can drive the protection umbrella to retract into the umbrella protection assembly, and when the umbrella protection assembly is connected with the near end of the second sheath assembly, the first sheath tube can push the protection umbrella from the umbrella protection assembly to the second sheath assembly. According to the endocavitary interventional operation device, the umbrella protection assembly is used for guiding the protection umbrella to smoothly enter the second sheath tube from the near end of the second sheath assembly, operation convenience and safety are provided, thrombus and plaques in a blood vessel are captured in the whole process through the protection umbrella, and the cerebral infarction occurrence rate is reduced.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an endovascular interventional surgical device. Background Technology

[0002] Endovascular interventional surgery is increasingly used in clinical treatment due to its advantages such as safety, minimal invasiveness, and rapid recovery. For example, thoracic endovascular aortic repair (TEVAR) can be used for minimally invasive treatment of aortic aneurysms and aortic dissections.

[0003] In related technologies, when performing endovascular interventional surgery, instruments such as guidewires, catheters, and balloons are usually inserted into the blood vessels of the human body and guided along the blood vessels to the lesion site, where surgical treatment is then performed.

[0004] However, during intravascular manipulation, thrombi or plaques in the aorta or its branches can easily dislodge and flow into intracranial arteries, obstructing blood flow and causing stroke. Capturing thrombi or plaques using conventional methods is cumbersome and can easily interfere with the operation of other instruments. For example, when using a guidewire-guided umbrella technique to capture thrombi or plaques within a blood vessel, the guidewire must be kept in place within the vessel throughout the procedure. Subsequent procedures involve reconstructing the aortic arch and its three branch vessels; this guidewire can become entangled with subsequent catheters, potentially leading to stent failure and treatment failure. Summary of the Invention

[0005] Based on this, an endovascular interventional surgical device is provided to address the problem of how to improve the ease and safety of operation while reducing the probability of cerebral infarction.

[0006] This application provides an endovascular interventional surgical device, comprising:

[0007] The first sheath assembly includes a protective umbrella and a first sheath tube, the protective umbrella being connected to the distal end of the first sheath tube; the protective umbrella has a compressed state and an inflated state, the diameter of the protective umbrella in the inflated state being larger than the diameter in the compressed state;

[0008] Second sheath assembly;

[0009] The umbrella protection assembly is detachably connected to the proximal end of the second sheath assembly;

[0010] The first sheath is axially movable and passes through the umbrella protection assembly, and can drive the umbrella to retract into the umbrella protection assembly. When the umbrella protection assembly is connected to the proximal end of the second sheath assembly, the first sheath can push the umbrella from the umbrella protection assembly to the second sheath assembly.

[0011] In some embodiments, the first sheath assembly further includes a first sheath seat, a sealing cap, and a first sealing ring. The first sheath seat is connected to the proximal end of the first sheath tube, the sealing cap is connected to the first sheath seat, and the first sealing ring is disposed inside the first sealing cap. The first sealing ring is used to seal the connection position between the sealing cap and the first sheath seat.

[0012] In some embodiments, the first sheath includes an inner layer and an outer layer sleeved on the inner layer; the proximal end of the protective umbrella is embedded in the outer layer, or the proximal end of the protective umbrella is sandwiched between the inner layer and the outer layer.

[0013] In some embodiments, the protective umbrella includes a woven mesh and a plurality of wire end restraints. The woven mesh is made of metal wires, and the metal wires extend from the far end of the woven mesh to form an outlet end. The plurality of wire end restraints are connected to the outlet end.

[0014] In some embodiments, the protective umbrella includes a developing tube disposed on the woven mesh, the developing tube being sleeved on the head end of the metal wire and woven synchronously with the corresponding metal wire, the developing tube being made of platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy, barium sulfate, bismuth trioxide, or tungsten.

[0015] In some embodiments, the material of the wire end constraint is platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy, barium sulfate, bismuth trioxide, or tungsten.

[0016] In some embodiments, the second sheath assembly includes a second sheath tube, a second sheath seat, a clamping member, and a second sealing ring. The second sheath seat is connected to the proximal end of the second sheath tube, the clamping member is connected to the second sheath seat, and the second sealing ring abuts against the proximal end face of the second sheath seat via the clamping member.

[0017] In some embodiments, the umbrella protection assembly includes an inner cavity constraint and a positioning member, the inner cavity constraint having a cavity extending through it along its axial direction, the positioning member being movably connected to the inner cavity constraint, and the positioning member being detachably connected to the clamping member.

[0018] In some embodiments, the clamping member includes a locking portion, and the positioning member includes a first engaging portion. The positioning member is movable to a locked position and an unlocked position relative to the inner cavity constraint member. When the positioning member is in the unlocked position, it can move distally relative to the second sheath seat so that the first engaging portion is opposite the locking portion. When the positioning member switches from the unlocked position to the locked position, the first engaging portion engages with the locking portion and axially locks the positioning member to the clamping member. When the positioning member switches from the locked position to the unlocked position, the first engaging portion is released from the locking portion, and the inner cavity constraint member can move proximally relative to the second sheath seat to separate from the second sheath seat.

[0019] In some embodiments, the positioning element is rotatably connected to the outer periphery of the inner cavity constraint, and the positioning element switches between the locked position and the unlocked position by rotating about the axial direction of the inner cavity constraint.

[0020] In some embodiments, the positioning member includes a main body and a rotating connecting part connected to each other. The main body surrounds a receiving cavity. The first snap-fit ​​part is disposed on the inner wall of the receiving cavity. The rotating connecting part is rotatably engaged with the inner cavity constraint member. The locking part includes a communicating guide groove and a limiting groove. The guide groove extends from the limiting groove and penetrates the proximal end face of the clamping member. The limiting groove extends circumferentially along the clamping member. The guide groove is used to guide the first snap-fit ​​part to move to be opposite the limiting groove. When the first snap-fit ​​part moves to be opposite the limiting groove, the positioning member rotates about the axial direction of the inner cavity constraint member, and the first snap-fit ​​part moves from the guide groove to the limiting groove.

[0021] In some embodiments, the inner cavity constraint has a guide portion, a portion of the lumen of the inner cavity constraint is formed in the guide portion; an annular space is formed between the guide portion and the inner wall of the receiving cavity, and when the positioning member cooperates with the clamping member, the proximal end of the clamping member enters the annular space, and the guide portion is inserted into the second sheath.

[0022] In some embodiments, the distal end of the guide extends beyond the distal end of the positioning member.

[0023] In some embodiments, the endovascular interventional surgical device includes a dilator that can be inserted through the proximal end of the second sheath assembly into the second sheath assembly, and the dilator is axially movable relative to the second sheath assembly.

[0024] In some embodiments, the expander includes an expansion tube and a connector, the connector being connected to the proximal end of the expansion tube; the connector includes a second snap-fit ​​portion for detachably connecting to the locking portion.

[0025] In some embodiments, the connector includes a sleeve portion and an interface portion, the interface portion being connected to the proximal end of the sleeve portion and the inner cavity of the interface portion communicating with the sleeve portion, the proximal end of the expansion tube extending into the sleeve portion and communicating with the inner cavity of the interface portion, and the second snap-fit ​​portion being disposed on the inner wall of the sleeve portion.

[0026] In some embodiments, the umbrella protection assembly includes a lock nut and a third sealing ring, the lock nut being threaded to the proximal end of the inner cavity constraint, and the third sealing ring being used to seal the connection between the lock nut and the inner cavity constraint.

[0027] In the aforementioned endovascular interventional surgical device, the protective umbrella is kept in a compressed state under the constraint of the umbrella protection assembly. Therefore, when the umbrella protection assembly is connected to the proximal end of the second sheath assembly, the first sheath can be manipulated to push the compressed protective umbrella from the umbrella protection assembly to the second sheath assembly. During this process, the umbrella protection assembly guides the protective umbrella, facilitating its smooth entry into the second sheath assembly from its proximal end. After guiding the protective umbrella into the second sheath assembly using the umbrella protection assembly, the first sheath can be manipulated to push the protective umbrella along the second sheath assembly into a specific blood vessel, allowing the protective umbrella to capture any plaque or thrombus that dislodges during endovascular treatment. Because the protective umbrella does not require a guidewire connection in the first sheath assembly, the first sheath can maintain a patent channel, serving as a pathway for subsequent instruments to enter the blood vessel. In addition, the protective umbrella can be retrieved to the umbrella protection assembly by operating the first sheath. When the umbrella protection assembly is removed from the second sheath assembly, the plaque or thrombus captured by the protective umbrella can be removed from the body by removing the umbrella protection assembly together with the first sheath assembly, so as to protect intracranial blood vessels from being blocked and reduce the incidence of cerebral infarction. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other embodiments can be obtained from these drawings without creative effort.

[0029] Figure 1 This is a schematic diagram of the structure of an endovascular interventional surgical device according to one embodiment.

[0030] Figure 2This is a schematic diagram of the structure of an endovascular interventional surgical device according to one embodiment, showing the first sheath assembly moving axially relative to the umbrella protection assembly.

[0031] Figure 3 This is a schematic diagram of the structure of an endovascular interventional surgical device according to one embodiment, in which the first sheath assembly moves distally relative to the umbrella protection assembly and pushes the protective umbrella out from the distal end of the second sheath assembly.

[0032] Figure 4 This is a schematic diagram of the structure of the first sheath assembly of an endovascular interventional surgical device according to one embodiment.

[0033] Figure 5 This is a schematic diagram of the protective umbrella structure of the first sheath assembly in an endovascular interventional surgical device according to one embodiment.

[0034] Figure 6 This is a schematic cross-sectional view of the connection point between the protective umbrella of the first sheath assembly and the first sheath tube in an endovascular interventional surgical device according to one embodiment.

[0035] Figure 7 This is a schematic diagram of the structure of the second sheath assembly of an endovascular interventional surgical device according to one embodiment.

[0036] Figure 8 This is a schematic diagram of the umbrella protection assembly of an endovascular interventional surgical device according to one embodiment.

[0037] Figure 9 This is a schematic diagram of the assembly structure of the first sheath assembly and the umbrella protection assembly in an endovascular interventional surgical device according to one embodiment.

[0038] Figure 10 This is a schematic diagram of the assembly of the dilator and the second sheath assembly in an endovascular interventional surgical device according to one embodiment.

[0039] Figure 11 This is a cross-sectional structural diagram of the dilator in an endovascular interventional surgical device according to one embodiment.

[0040] Figure 12 This is a schematic diagram showing the result of the dilator and second sheath assembly entering a blood vessel during the use of an endovascular interventional surgical device according to one embodiment.

[0041] Figure 13 This is a schematic diagram of the structure of the endovascular interventional surgical device in one embodiment, showing the dilator and the second sheath assembly entering the blood vessel and then withdrawing the dilator.

[0042] Figure 14 This is a schematic diagram of the structure of the endovascular interventional surgical device according to one embodiment, during use, in which the protective umbrella of the first sheath assembly is constrained by the umbrella protection assembly, and the umbrella protection assembly is engaged with the second sheath assembly.

[0043] Figure 15 This is a schematic diagram showing the structure of an endovascular interventional surgical device according to one embodiment, in which the umbrella protection component and the second sheath component cooperate, and the protective umbrella of the first sheath component is pushed out from the distal end of the second sheath component.

[0044] Figure 16 This is a schematic diagram of the structure in which the protective umbrella of the first sheath assembly is attached to the blood vessel wall during the use of an endovascular interventional surgical device according to one embodiment.

[0045] Figure 17 This is a schematic diagram showing the structure of an endovascular interventional surgical device according to one embodiment, during use, when the protective umbrella is retracted to the umbrella protection assembly and the umbrella protection assembly is separated from the proximal end of the second sheath assembly.

[0046] Figure label:

[0047] 100. Endovascular interventional surgical device; 10. First sheath assembly; 11. Protective umbrella; 111. Braided mesh; 112. Thread restraint; 113. Imaging tube; 114. Straight tube section; 12. First sheath tube; 121. Inner layer; 122. Outer layer; 13. First sheath seat; 131. First infusion tube assembly; 14. Sealing and clamping cap; 15. First sealing ring; 20. Second sheath assembly; 21. Second sheath tube; 22. Second sheath seat; 221. Second infusion tube assembly; 23. Clamping element; 231. Locking part; 2311. Guide groove; 2312 1. Limiting groove; 24. Second sealing ring; 30. Umbrella protection assembly; 31. Inner cavity constraint; 311. Guide part; 312. Snap-fit ​​groove; 32. Positioning part; 321. First snap-fit ​​part; 322. Main body part; 322a. Receiving cavity; 323. Rotating connection part; 3231. Protrusion; 33. Locking nut; 34. Third sealing ring; 40. Diverter; 41. Diverter tube; 411. Main body section; 412. Guide section; 42. Connector; 421. Second snap-fit ​​part; 422. Sleeve part; 423. Interface part; VW. Blood vessel wall. Detailed Implementation

[0048] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0049] It should be noted that when a component is described as "fixed to" or "set on" another component, it can be directly on the other component or there may be an intervening component. When a component is described as "connected to" another component, it can be directly connected to the other component or there may be an intervening component.

[0050] The terms “vertical,” “horizontal,” “up,” “down,” “left,” “right,” and similar expressions are for illustrative purposes only and do not represent the only possible implementation.

[0051] It should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application 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 this application.

[0052] It should be noted that the terms "distal" and "proximal" are used as directional terms in the field of interventional medical devices. "Distal" refers to the end furthest from the operator (e.g., the doctor) during surgery, or the end relatively far from the patient's heart during the procedure. "Proximal" refers to the end closest to the operator during surgery, or the end closest to the patient's heart during the procedure. Axial direction refers to the direction in which the central axis of the medical device extends; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0053] See Figure 1 As shown, this application provides an endovascular interventional surgical device 100 adapted for endovascular interventional surgery. The endovascular interventional surgical device 100 of this application can capture plaques and thrombi generated during endovascular treatment, thereby reducing the probability of cerebral infarction caused by thrombi or plaques breaking off into intracranial arteries and obstructing blood flow.

[0054] The endovascular interventional surgical device 100 includes a first sheath assembly 10, a second sheath assembly 20, and a protective umbrella assembly 30. The proximal end of the second sheath assembly 20 is detachably connected to the protective umbrella assembly 30.

[0055] Combination Figure 2 As shown, the first sheath assembly 10 includes a protective umbrella 11 and a first sheath tube 12. The protective umbrella 11 is connected to the distal end of the first sheath tube 12.

[0056] The protective umbrella 11 has a compressed state and an expanded state, and the diameter of the protective umbrella 11 in the expanded state is larger than the diameter in the compressed state. The first sheath 12 is axially movable and passes through the umbrella protection assembly 30, and can drive the protective umbrella 11 to retract into the umbrella protection assembly 30, so that the protective umbrella 11 is in a compressed state under the constraint of the umbrella protection assembly 30.

[0057] Combination Figure 3 As shown, when the umbrella protection assembly 30 is connected to the proximal end of the second sheath assembly 20, the first sheath tube 12 can push the umbrella 11 from the umbrella protection assembly 30 to the second sheath assembly 20, and the first sheath tube 12 can push the umbrella 11 along the second sheath assembly 20, thereby releasing the umbrella 11 from the distal end of the second sheath assembly 20.

[0058] In this embodiment, since the protective umbrella 11 is kept in a compressed state under the constraint of the umbrella protection assembly 30, when the umbrella protection assembly 30 is connected to the proximal end of the second sheath assembly 20, the first sheath tube 12 can be operated to push the compressed protective umbrella 11 from the umbrella protection assembly 30 to the second sheath assembly 20. During this process, the umbrella protection assembly 30 can guide the protective umbrella 11, facilitating the smooth entry of the protective umbrella 11 from the proximal end of the second sheath assembly 20 into the second sheath assembly 20.

[0059] During endovascular treatment, the second sheath assembly 20 can be inserted into the blood vessel first, and then the first sheath assembly 10 can be moved proximally relative to the umbrella protection assembly 30 to constrain the protective umbrella 11. When the umbrella protection assembly 30 is connected to the second sheath assembly 20, it guides the first sheath assembly 10 into the second sheath assembly 20, avoiding the difficulty of the protective umbrella 11 of the first sheath assembly 10 entering the second sheath assembly 20 when it is inflated. Therefore, the umbrella protection assembly 30 ensures smooth entry of the protective umbrella 11 from the proximal end of the second sheath assembly 20, improves operational convenience, and reduces safety risks caused by cumbersome procedures.

[0060] Understandably, combined Figure 3 As shown, after the first sheath assembly 10 enters the second sheath assembly 20, the first sheath assembly 10 can move axially within the second sheath assembly 20. Since the protective umbrella 11 has a compressed state and an expanded state, the diameter of the protective umbrella 11 in the expanded state is larger than its diameter in the compressed state. Subsequently, when the distal end of the first sheath tube 12 extends from the distal end of the second sheath assembly 20, the protective umbrella 11 is released from the distal end of the second sheath assembly 20 and expands radially along the second sheath assembly 20; when the first sheath assembly 10 moves relative to the second sheath assembly 20 toward the umbrella protection assembly 30, the first sheath tube 12 can retract the protective umbrella 11 into the second sheath assembly 20 and allow the protective umbrella 11 to move along the second sheath assembly 20 into the inner cavity of the umbrella protection assembly 30.

[0061] Because the diameter of the protective umbrella 11 in its expanded state is larger than that in its compressed state, when the first sheath 12 pushes the protective umbrella 11 along the second sheath assembly 20 to a suitable position (which can be understood as a suitable position for capturing thrombi) for release, the protective umbrella 11 switches from a compressed state to an expanded state, thereby bringing the protective umbrella 11 into contact with the vessel wall VW (see...). Figure 15 (As shown). Thus, the protective umbrella 11 can be used to capture plaque and thrombus generated during endovascular treatment. At this time, the first sheath 12 of the first sheath assembly 10 can be adapted to create a delivery channel for the device. Compared to related technologies that require a guidewire to be pre-drilled in the blood vessel to connect to the protective umbrella 11, the endovascular interventional surgical device 100 of this application can capture thrombi and plaque generated during endovascular treatment without pre-drilling a guidewire in the blood vessel, improving operational convenience and safety.

[0062] For plaque or thrombus detachment during endovascular treatment of aortic arch vascular lesions, the endovascular interventional surgical device 100 of this application can place a protective umbrella 11 in a specific blood vessel to capture the detached plaque or thrombus. Since the protective umbrella 11 does not need to be connected to a guidewire in the first sheath assembly 10, the first sheath 12 can maintain a patent channel for subsequent instrument entry into the blood vessel. Because the first sheath 12 is axially movable through the umbrella protective assembly 30, the protective umbrella 11 can be retrieved into the umbrella protective assembly 30 by manipulating the first sheath 12. At this point, the umbrella protective assembly 30 can be detached from the second sheath assembly 20, allowing the plaque or thrombus captured by the protective umbrella 11 to be removed from the body by withdrawing the umbrella protective assembly 30 along with the first sheath assembly 10, thereby protecting intracranial blood vessels from blockage and reducing the incidence of cerebral infarction.

[0063] Combination Figure 4 As shown, in some embodiments, the first sheath assembly 10 further includes a first sheath seat 13 and a sealing compression cap 14 connected to the first sheath seat 13. The first sheath seat 13 is connected to the proximal end of the first sheath tube 12. A first sealing ring 15 is disposed inside the sealing compression cap 14, which is used to seal the connection position between the sealing compression cap 14 and the first sheath seat 13. This prevents leakage at the proximal end of the first sheath assembly 10. It should be noted that, based on the sealing effect of the first sealing ring 15, blood will not leak from the proximal end of the first sheath assembly 10 during surgery using the endovascular interventional surgical device 100.

[0064] Understandably, when medical fluids such as saline are infused into a blood vessel using the first sheath assembly 10, the first sealing ring 15 prevents leakage of the medical fluid from the proximal end of the first sheath assembly 10. For example, in some embodiments, a first infusion tubing assembly 131 is connected to the first sheath seat 13, and the first infusion tubing assembly 131 is connected to the first sheath tube 12 via the first sheath seat 13. Thus, medical fluids can be delivered via the first infusion tubing assembly 131 through the first sheath assembly 10. Due to the first sealing ring 15, the medical fluids infused into the first sheath seat 13 by the first infusion tubing assembly 131 will not leak from the proximal end of the first sheath assembly 10.

[0065] Combination Figure 5 As shown, the shape of the protective umbrella 11 in its inflated state can be semi-ellipsoidal, spherical, or sac-like, and is not limited here. The important thing is that the protective umbrella 11, in its inflated state, can adhere to the vessel wall (VW) to capture thrombi or plaques.

[0066] The proximal end of the protective umbrella 11 is tubular (i.e., straight) with a fixed radius. For ease of description, the straight tubular portion of the proximal end of the protective umbrella 11 is referred to as the "straight tube segment 114". Understandably, the diameter of the protective umbrella 11 in its expanded state (which can be understood as the diameter of the protective umbrella 11 at the point of contact with the vessel wall VW in its expanded state) is larger than the diameter of the straight tube segment 114. Since the straight tube segment 114 is connected to the distal end of the first sheath 12, the connection point between the straight tube segment 114 and the first sheath 12 cannot expand and thus maintains a fixed diameter. In other words, the proximal end of the straight tube segment 114 is tubular with a fixed diameter under the constraint of the first sheath 12.

[0067] Combination Figure 6 As shown, the first sheath 12 includes an inner layer 121 and an outer layer 122 sleeved on the inner layer 121. The proximal end of the protective umbrella 11 is embedded in the outer layer 121, or the proximal end of the protective umbrella 11 is sandwiched between the inner layer 121 and the outer layer 122.

[0068] The straight tube segment 114 can be fixed between the inner layer 121 and the outer layer 122 of the first sheath 12 by heat fusion. The straight tube segment 114 can also be fixed to the distal end of the first sheath 12 in other ways. For example, the straight tube segment 114 can be wrapped around the distal end of the first sheath 12 using heat shrink tubing.

[0069] In some embodiments, the inner layer 121 of the first sheath 12 can be made of polymer materials such as PTFE (Polytetrafluoroethylene) or PA (Polyamide); the outer layer 122 of the first sheath 12 can be made of polymer materials such as Pebax (polyether block polyamide), PA (Polyamide) or PE (Polyethylene).

[0070] After the inner layer 121 and the outer layer 122 of the first sheath 12 are combined, the first sheath 12 can be connected to the first sheath seat 13 by injection molding or adhesive. The connection between the first sheath 12 and the first sheath seat 13 can also be a detachable connection such as a threaded connection or a snap-fit ​​connection. The connection method between the first sheath 12 and the first sheath seat 13 is not limited here.

[0071] In some implementations, combined Figure 5 As shown, the protective umbrella 11 includes a woven mesh 111 and multiple wire end restraints 112. The woven mesh 111 is made of woven metal wires, with the metal wires extending from the far end of the woven mesh 111 to form an outlet end. The multiple wire end restraints 112 are connected to the outlet end to restrain the metal wires. This ensures that the woven structure of the metal wire mesh 111 remains stable and does not loosen.

[0072] It should be noted that the weaving method of the woven mesh 111 can be varied. For example, in some embodiments, the stitches used when weaving the woven mesh 111 can be one knit one knit, one knit two knit, two knit one knit, or two knit two knit, etc. To improve the production efficiency of the woven mesh 111, an automatic weaving machine can be used to process the woven mesh 111.

[0073] The metal wire used to make the woven mesh 111 can be made of nickel-titanium alloy wire.

[0074] In some embodiments, when using nickel-titanium alloy wire to make the woven mesh 111, 96 strands of wire can be used for weaving. It should be noted that the woven mesh 111 is not limited to the above number of strands. In practical applications, depending on the support effect of the woven mesh 111 and the need for thrombus capture, a suitable number of strands of metal wire can be used to weave the woven mesh 111 with a suitable mesh size.

[0075] The mesh size of the woven mesh 111 and the material and number of strands of the metal wire used to make the woven mesh 111 are not limited here.

[0076] The protective umbrella 11 includes a developing structure, which can be a developing tube 113 disposed on the woven mesh 111.

[0077] In some embodiments, the head end (i.e., the distal end) of the woven mesh 111 can be divided into several large strands. Taking 96 strands of nickel-titanium alloy wire woven into the woven mesh 111 as an example, the 96 strands of nickel-titanium alloy wire can be divided into 6 large strands, and each large strand contains 16 strands of nickel-titanium alloy wire. The nickel-titanium alloy wires divided into 6 large strands are inserted into the interior of 6 wire end restraint members 112, so that each strand of nickel-titanium alloy wire is not easily loosened under the restraint of the corresponding wire end restraint member 112, so that the woven mesh 111 maintains a stable woven shape.

[0078] It should be noted that the material of the wire end constraint 112 can be a developing material such as platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy, barium sulfate, bismuth trioxide, or tungsten, so that the wire end constraint 112 can be reused as a developing tube 113.

[0079] Taking the imaging tube 113, which includes a platinum-iridium alloy tube, as an example, six large strands of nickel-titanium alloy wire are inserted into the interior of the six platinum-iridium alloy tubes respectively. At this time, the platinum-iridium alloy tube can not only serve as a wire end constraint 112 to constrain the wire end of the nickel-titanium alloy wire, but also be used for intraoperative imaging and positioning.

[0080] It should be noted that the threaded constraint 112 can be made of platinum-iridium alloy tubing or other structures. For example, platinum-iridium alloy tubing can also be replaced by nickel-titanium alloy tubing.

[0081] The imaging method is not limited to using the imaging tube 113 as a wire end constraint 112 fitted onto the end of the metal wire. In some embodiments, the imaging tube 113 may be fitted onto some of the metal wires to be braided synchronously with the metal wires, thereby being used for intraoperative imaging and positioning.

[0082] For example, the developing tube 113 is fitted onto the head end of the metal wire and is woven synchronously with the corresponding metal wire.

[0083] The developing tube 113 is made of platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy, barium sulfate, bismuth trioxide, or tungsten.

[0084] Taking platinum-iridium material as an example, the imaging tube 113 is a platinum-iridium alloy imaging tube 113. The platinum-iridium alloy imaging tube 113 is fitted onto the end of the metal wire, so that the platinum-iridium alloy imaging tube 113 is synchronously woven with the corresponding metal wire, thus the platinum-iridium alloy imaging tube 113 can be used for intraoperative imaging and positioning.

[0085] The developing tube 113 and the internal metal wires can be fixed by laser welding or adhesive.

[0086] Combination Figure 7As shown, the second sheath assembly 20 includes a second sheath tube 21 and a second sheath seat 22. The second sheath seat 22 is connected to the proximal end of the second sheath tube 21. The second sheath assembly 20 can control the restraint and release of the first sheath assembly 10. For example, the first sheath tube 12 passes through the second sheath tube 21. Thus, when the first sheath tube 12 is moved proximally relative to the second sheath tube 21, the protective umbrella 11 located at the distal end of the first sheath tube 12 can be moved into the second sheath tube 21, thereby using the second sheath tube 21 to restrain the protective umbrella 11. Correspondingly, when it is necessary to release the protective umbrella 11, it is only necessary to operate the first sheath tube 12 and the second sheath tube 21 to move axially relative to each other so that the protective umbrella 11 located at the distal end of the first sheath tube 12 moves out from the distal end of the second sheath tube 21, and the protective umbrella 11 will be released due to the loss of restraint from the second sheath tube 21.

[0087] Furthermore, the second sheath assembly 20 includes a clamping member 23 and a second sealing ring 24. The clamping member 23 is connected to the second sheath seat 22, and the second sealing ring 24 abuts against the proximal end face of the second sheath seat 22 via the clamping member 23. The second sealing ring 24 is used to seal the connection position between the clamping member 23 and the second sheath seat 22. A second infusion tube assembly 221 is connected to the second sheath seat 22, and the second infusion tube assembly 221 communicates with the second sheath tube 21 through the second sheath seat 22.

[0088] The second sheath 21 can be a thin-walled single-layer tube, thereby reducing the outer diameter of the entire system. The material of the second sheath 21 can be a polymer material such as Pebax (polyether block polyamide), PA (polyamide), or PE (polyethylene).

[0089] The second sheath 21 can also be a multi-layer composite tube to enhance its special properties, such as tensile strength, flexibility, and shape retention. For example, in some embodiments, the second sheath 21 includes an inner layer, a middle layer, and an outer layer sequentially nested together. The inner layer of the second sheath 21 can be made of polymer materials such as PTFE (Polytetrafluoroethylene) or PA (Polyamide); the middle layer of the second sheath 21 can have a braided or spring-like structure, and its material can be metal materials such as stainless steel or titanium alloy; the outer layer of the second sheath 21 can be made of polymer materials such as Pebax (polyether block polyamide), PA (Polyamide), or PE (Polyethylene). In the second sheath 21, the inner and outer layers can be connected to the middle layer by heat fusion.

[0090] The inner surface and / or outer surface of the second sheath 21 may be coated with a hydrophilic coating to reduce the resistance to introduction.

[0091] In some embodiments, the second sheath tube 21 and the second sheath base 22 may be connected by injection molding, gluing or other means.

[0092] Combined with Figure 8 As shown, the umbrella protection component 30 includes a lumen constraint member 31 and a positioning member 32. The lumen constraint member 31 has a lumen axially penetrating therethrough. The positioning member 32 is movably connected to the lumen constraint member 31, and the positioning member 32 is used for detachably connecting to the pressing member 23. In this embodiment, the positioning member 32 is connected to and detached from the pressing member 23 by moving the positioning member 32 relative to the lumen constraint member 31.

[0093] Regarding the detachable connection manner between the positioning member 32 and the pressing member 23 of the second sheath base 22, it may specifically be snap docking or locking connection, which is not limited herein.

[0094] For the convenience of understanding, the following combines Figure 7 and Figure 8 As shown to illustrate the locking and unlocking of the positioning member 32 and the pressing member 23 of the second sheath base 22 by their structures, but the structures of the positioning member 32 and the pressing member 23 are not limited thereto.

[0095] For the convenience of description, the position of the positioning member 32 relative to the lumen constraint member 31 when the positioning member 32 cooperates with the pressing member 23 is hereinafter referred to as the "locking position", and the position of the positioning member 32 relative to the lumen constraint member 31 when the positioning member 32 is disengaged from the pressing member 23 is referred to as the "unlocking position". Then, the positioning member 32 can move relative to the lumen constraint member 31 to the locking position and the unlocking position.

[0096] Combined with Figure 7 As shown, the pressing member 23 includes a locking portion 231. Combined with Figure 8 As shown, the positioning member 32 includes a first clamping portion 321. When the positioning member 32 is in the unlocking position, the positioning member 32 can move distally relative to the second sheath base 22 to make the first clamping portion 321 opposite to the locking portion 231. At this time, when the positioning member 32 is switched from the unlocking position to the locking position, the first clamping portion 321 cooperates with the locking portion 231 and axially locks the positioning member 32 to the pressing member 23, so that the lumen constraint member 31 and the pressing member 23 cannot move axially, realizing the stable connection between the lumen constraint member 31 and the pressing member 23. Correspondingly, when it is necessary to separate the lumen constraint member 31 from the pressing member 23, the positioning member 32 is operated to be switched from the locking position to the unlocking position to release the locking between the first clamping portion 321 and the locking portion 231, and the axial limit of the lumen constraint member 31 along the axis with respect to the pressing member 23 can be released, so that the lumen constraint member 31 can move proximally relative to the pressing member 23 along the axis, thereby realizing the separation of the lumen constraint member 31 and the pressing member 23.

[0097] Furthermore, the positioning element 32 is rotatably connected to the outer periphery of the inner cavity constraint element 31. The positioning element 32 switches between a locked position and an unlocked position by rotating about the axial direction of the inner cavity constraint element 31. This rotational operation method for switching the position of the positioning element 32 is simple to operate and has good reliability.

[0098] Continue to combine Figure 8 As shown, the positioning member 32 includes a main body portion 322 and a rotating connecting portion 323 connected to each other. The main body portion 322 encloses a receiving cavity 322a, and a first snap-fit ​​portion 321 is provided on the inner wall of the receiving cavity 322a. The rotating connecting portion 323 is rotatably engaged with the inner cavity constraint member 31, thereby enabling the main body portion 322 to rotate axially relative to the inner cavity constraint member 31.

[0099] The locking part 231 includes a communicating guide groove 2311 and a limiting groove 2312. The guide groove 2311 extends from the limiting groove 2312 and passes through the proximal end face of the clamping member 23, and the limiting groove 2312 extends circumferentially along the clamping member 23. When the positioning member 32 is connected to the clamping member 23, the positioning member 32 can be moved distally relative to the clamping member 23, so that the clamping member 23 enters the receiving cavity 322a, and the first engaging part 321 moves along the guide groove 2311 toward the limiting groove 2312. When the first engaging part 321 moves to be opposite the limiting groove 2312, the positioning member 32 is rotated axially about the inner cavity constraint member 31, and the first engaging part 321 moves from the guide groove 2311 to the limiting groove 2312. Since the limiting groove 2312 extends circumferentially along the clamping member 23, after the first engaging part 321 enters the limiting groove 2312, the cooperation between the first engaging part 321 and the limiting groove 2312 can restrict the clamping member 23 and the positioning member 32 to move relative to each other along the axial direction, thereby achieving the effect of locking the inner cavity constraint member 31 and the clamping member 23.

[0100] It should be noted that the main body 322 and the rotating connection 323 can be integrally formed, or they can be connected by screws or welding.

[0101] In some embodiments, the outer wall of the inner cavity constraint 31 is provided with a snap-fit ​​groove 312 extending circumferentially therein, and the rotating connection part 323 has a protrusion 3231 that engages with the snap-fit ​​groove 312.

[0102] In this embodiment, when the rotating connection 323 rotates about the axial direction relative to the inner cavity constraint 31, the protrusion 3231 moves along the snap-fit ​​groove 312. Thus, the cooperation between the protrusion 3231 and the snap-fit ​​groove 312 ensures that the positioning member 32 remains connected to the inner cavity constraint 31 when rotating relative to the inner cavity constraint 31, thus preventing the positioning member 32 from falling off the inner cavity constraint 31.

[0103] It should be noted that the cooperation between the protrusion 3231 and the snap-fit ​​groove 312 not only achieves the axial positioning of the positioning member 32 and the inner cavity constraint member 31, but also, by utilizing the characteristic that the snap-fit ​​groove 312 extends circumferentially along the inner cavity constraint member 31, the positioning member 32 has a degree of rotational freedom about the inner cavity constraint member 31 in the axial direction. In other words, the cooperation between the protrusion 3231 and the snap-fit ​​groove 312 also serves as a structure to realize the rotational connection part 323 and the inner cavity constraint member 31 rotating about the axial direction.

[0104] In some embodiments, the inner cavity constraint 31 has a guide portion 311. A portion of the lumen of the inner cavity constraint 31 is formed in the guide portion 311. An annular space is formed between the guide portion 311 and the inner wall of the receiving cavity 322a.

[0105] When the positioning member 32 and the clamping member 23 are engaged, the proximal end of the clamping member 23 enters the annular space, and the guide part 311 is inserted into the second sheath tube 21.

[0106] In this embodiment, on the one hand, the guide part 311 connects the cavity of the inner cavity constraint member 31 to the second sheath tube 21; on the other hand, the guide part 311 is inserted into the second sheath tube 21 so as to guide the protective umbrella 11 from the inner cavity of the inner cavity constraint member 31 into the second sheath tube 21, so that the compressed protective umbrella 11 can enter the second sheath tube 21 more smoothly.

[0107] The distal end of the guide portion 311 is chamfered so that when the positioning member 32 and the clamping member 23 are engaged, the guide portion 311 can be smoothly inserted into the second sheath tube 21 by utilizing the chamfer at its distal end.

[0108] The distal end of the guide portion 311 extends beyond the distal end of the positioning member 32, thereby allowing the guide portion 311 to have sufficient length to penetrate the clamping member 23 and the second sheath seat 22 and communicate with the second sheath tube 21.

[0109] In an embodiment where a second sealing ring 24 is provided within the clamping member 23, the diameter of the central hole of the second sealing ring 24 is smaller than the outer diameter of the guide portion 311. Thus, when the guide portion 311 is inserted into the clamping member 23, it passes through the central hole of the second sealing ring 24, and the second sealing ring 24 seals against (i.e., the edge forming the central hole) the guide portion 311, thereby providing a sealing effect around the guide portion 311.

[0110] In some embodiments, the guide 311 can protect the protective umbrella 11 by constraining the protective umbrella 11 located at the distal end of the first sheath 12.

[0111] For example, when used during surgery, in combination Figure 9 As shown, the umbrella protection assembly 30 and the first sheath assembly 10 are arranged according to... Figure 9 They are assembled together in a certain way.

[0112] The first sheath 12 passes through the cavity of the inner constraint member 31. This allows the umbrella protection assembly 30 to be moved distally relative to the first sheath 12, bringing it closer to the protective umbrella 11 and ultimately confining the protective umbrella 11 within the cavity of the inner constraint member 31. Because the protective umbrella 11 is confined within the cavity of the inner constraint member 31 and not exposed when the distal end of the first sheath 12 is moved into the cavity of the inner constraint member 31, the protective umbrella 11 will smoothly pass through the second sealing ring 24 under the protection of the guide portion 311 when the guide portion 311 of the inner constraint member 31 is inserted from the proximal end of the second sheath assembly 20.

[0113] See again Figure 8 As shown, in some embodiments, the umbrella protection assembly 30 includes a third sealing ring 34 and a locking nut 33. The locking nut 33 is threaded to the proximal end of the inner cavity constraint 31. The third sealing ring 34 serves to seal between the locking nut 33 and the inner cavity constraint 31, i.e., the third sealing ring 34 seals the connection position between the locking nut 33 and the inner cavity constraint 31. Furthermore, when the first sheath 12 passes through the cavity of the inner cavity constraint 31, the third sealing ring 34 is sealed and fitted onto the first sheath 12, thereby enabling the third sealing ring 34 to provide a sealing effect on the periphery of the first sheath 12.

[0114] It should be noted that the third sealing ring 34 can be disposed inside the cavity of the inner cavity constraint member 31 and abut against the inner wall of the cavity of the inner cavity constraint member 31 under the resistance of the locking nut 33, so that the third sealing ring 34 and the inner wall of the cavity have good sealing performance. In some embodiments, the third sealing ring 34 can also abut against the proximal end face of the inner cavity constraint member 31 under the resistance of the locking nut 33. In this way, the third sealing ring 34 can provide a sealing effect at the connection position between the locking nut 33 and the inner cavity constraint member 31 at the proximal end face of the inner cavity constraint member 31.

[0115] Combination Figure 10 As shown, in some embodiments, the endovascular interventional surgical device 100 includes a dilator 40, which is capable of being inserted through the proximal end of the second sheath assembly 20. The dilator 40 is axially movable relative to the second sheath assembly 20 so that after the second sheath assembly 20 is inserted into the blood vessel using the dilator 40, the dilator 40 can be removed from the proximal end of the second sheath assembly 20, thereby withdrawing the dilator 40 from the body.

[0116] In this embodiment, simply inserting the dilator 40 through the second sheath assembly 20 and inserting the dilator 40 into a specific blood vessel via a vascular puncture port allows the dilator 40 to guide the second sheath assembly 20 into the blood vessel.

[0117] After the dilator 40 is removed from the body, the second sheath assembly 20 can create a channel to allow the first sheath assembly 10 to enter. Specifically, the first sheath assembly 10 is assembled with the umbrella protection assembly 30, and the umbrella protection assembly 30 guides the first sheath assembly 10 smoothly through the second sheath assembly 20. In this way, the first sheath assembly 10 can enter the body along the second sheath assembly 20.

[0118] Understandably, once the first sheath assembly 10 enters the body, it can be used to construct a pathway to accommodate the need for the device to enter the body.

[0119] Continue to combine Figure 10 As shown, the expander 40 includes an expansion tube 41 and a connector 42. The connector 42 is connected to the proximal end of the expansion tube 41.

[0120] Furthermore, combined Figure 11 As shown, the dilator 41 includes a main body segment 411 and a guide segment 412 connected to the distal end of the main body segment 411. The guide segment 412 is tapered, and the small end of the guide segment 412 forms the distal end of the guide segment 412. In this way, the dilator 41 can be smoothly inserted into the proximal end of the second sheath assembly 20 using the guide segment 412, and after the distal end of the guide segment 412 exits from the distal end of the second sheath 21, the guide segment 412 also facilitates the insertion of the dilator 41 into the lesion site of the blood vessel.

[0121] During the insertion of the second sheath 21 and the dilator 41 into the blood vessel, the dilator 41 provides good support for the second sheath assembly 20 and reduces the chance of scratching the blood vessel wall VW by using the guide section 412.

[0122] The materials of the expansion tube 41 include, but are not limited to, polymer materials such as PE (Polyethylene) or PP (Polypropylene).

[0123] like Figure 11 As shown, the connector 42 includes a second snap-fit ​​portion 421, which is detachably connected to the locking portion 231 of the clamping member 23. In this embodiment, the assembly and disassembly of the expander 40 and the second sheath assembly 20 are quickly achieved by utilizing the cooperation between the second snap-fit ​​portion 421 and the locking portion 231. After the expander 40 is inserted into the second sheath assembly 20, it can serve a positioning and locking function.

[0124] It should be noted that the structure of the second snap-fit ​​part 421 is similar to that of the first snap-fit ​​part 321.

[0125] Continue to combine Figure 11As shown, in some embodiments, the connector 42 further includes a socket portion 422 and an interface portion 423. The interface portion 423 is connected to the proximal end of the socket portion 422, and the inner cavity of the interface portion 423 communicates with the socket portion 422. The proximal end of the expansion tube 41 extends into the socket portion 422 and communicates with the inner cavity of the interface portion 423. In this embodiment, a second snap-fit ​​portion 421 is provided on the inner wall of the socket portion 422.

[0126] In embodiments where the locking part 231 includes a communicating guide groove 2311 and a limiting groove 2312, when the expansion tube 41 is inserted into the second sheath assembly 20 and moved distally until the sleeve part 422 is fitted onto the clamping member 23, the connector 42 is moved distally relative to the clamping member 23, and the second locking part 421 moves along the guide groove 2311 to a position corresponding to the limiting groove 2312. At this time, by simply rotating the sleeve part 422 and the clamping member 23 relative to each other axially to move the second locking part 421 to the limiting groove 2312, the axial locking of the connector 42 and the clamping member 23 can be achieved by the cooperation of the second locking part 421 and the limiting groove 2312.

[0127] Because the proximal end of the dilator 41 is connected to the lumen of the interface portion 423, a guidewire can be inserted from the interface portion 423 into the dilator 41, allowing the guidewire to extend from the distal end of the dilator 41. This allows the guidewire to provide support for the dilator 41 as it enters the blood vessel, improving the stability and accuracy of its entry. After the dilator 41 enters the blood vessel, the guidewire can be withdrawn from the proximal end of the dilator 41.

[0128] Both the proximal end of the expansion tube 41 and the inner cavity of the interface portion 423 are formed with conical guides. The diameter of the conical guides gradually decreases in the direction from the proximal end to the distal end, so as to guide structures such as guide wires into the inner cavity of the interface portion 423 and the expansion tube 41 from the proximal end to the distal end.

[0129] To facilitate understanding, the following will be combined with... Figures 12 to 17 The use of the endovascular interventional surgical device 100 according to one embodiment of this application is described by way of example, but the use of the endovascular interventional surgical device 100 is not limited thereto.

[0130] Combination Figure 12 As shown, the dilator 40 is assembled with the second sheath assembly 20, such that the distal end of the dilator tube 41 extends from the distal end of the second sheath tube 21, and the connector 42 and the clamping member 23 are locked axially. Using the support and guiding effect of the dilator tube 41, the dilator 40 and the second sheath tube 21 are inserted into a specific blood vessel through the vascular puncture site, that is, the dilator 40 and the second sheath tube 21 enter the lumen formed by the vessel wall VW.

[0131] It should be noted that the direction in which the dilator 40 and the second sheath 21 are inserted into the blood vessel is opposite to the direction of blood flow in the blood vessel. In other words, the dilator 40 is inserted into the blood vessel in the opposite direction of blood flow.

[0132] Combination Figure 13 After the dilator 40 and the second sheath 21 are inserted into the blood vessel, the locking of the connector 42 and the clamping member 23 can be released first, and the dilator 40 can be moved proximally relative to the second sheath 21 to withdraw it from the body. At this time, the second sheath 21 remains in the body.

[0133] Combination Figure 14 As shown, the umbrella protection assembly 30 is moved toward the distal end relative to the first sheath tube 12, so that the umbrella protection assembly 30 is close to the protective umbrella 11, and finally the protective umbrella 11 is constrained in the cavity of the inner cavity constraint member 31.

[0134] Combination Figure 15 As shown, the umbrella protection assembly 30 and the first sheath assembly 10 are simultaneously brought closer to the clamping member 23 of the second sheath assembly 20. When the lumen of the inner cavity constraint member 31 mates with the second sheath tube 21 to achieve communication, the umbrella protection assembly 30 and the second sheath assembly 20 are locked. Then, the first sheath assembly 10 is pushed distally relative to the umbrella protection assembly 30, causing the first sheath tube 12 to move distally within the lumen of the inner cavity constraint member 31, so that the protective umbrella 11 at the distal end of the first sheath tube 12 is moved from the lumen of the inner cavity constraint member 31 to the second sheath tube 21.

[0135] After the protective umbrella 11 is transferred to the second sheath 21, the protective umbrella 11 can be moved distally along the second sheath 21 by manipulating the first sheath 12. During this process, the radiopaque structure of the protective umbrella 11 can be observed under X-ray to accurately adjust its position. For example, when the first sheath 12 pushes the protective umbrella 11 distally until its distal end coincides with the distal end of the second sheath 21, i.e., the protective umbrella 11 reaches the release position positioned by the second sheath 21, the second sheath 21 can be retracted proximally relative to the first sheath 12, thereby moving the protective umbrella 11 out of the distal end of the second sheath 21. In this way, the protective umbrella 11 expands due to the release of the second sheath 21 until it adheres to the vessel wall (VW).

[0136] Combination Figure 16 As shown, based on the fit between the protective umbrella 11 and the vessel wall VW, blood clots in the blood are captured by the protective umbrella 11 as the blood flows through it. Therefore, under the protection of the protective umbrella 11, a device can be implanted in any blood vessel distal to the protective umbrella 11 without worrying about plaque or thrombus formation during the implantation process flowing to the proximal side of the protective umbrella 11 and causing a stroke.

[0137] In some embodiments, the first sheath 12 can also be used to create a channel for delivering the device, allowing the device to be implanted into the body via the interior of the first sheath assembly 10. For example, a self-expanding stent system, a balloon-expandable stent system, or a balloon system can be implanted into a blood vessel via the first sheath assembly 10. The surgery is complete once the device has been implanted and withdrawn from the body.

[0138] Understandably, when the device is pushed to the implantation site along the channel constructed by the first sheath 12, the protective umbrella 11 can capture plaques and thrombi generated during the device implantation process, thereby preventing plaques and thrombi from flowing into the intracranial arteries and causing cerebral infarction. Thus, the protective umbrella 11 provides a protective effect. For example, if the vessel is the left common carotid artery, brachiocephalic artery, or left subclavian artery, the device can then be implanted in the aortic arch, ascending aorta, or descending aorta. Once plaques or thrombi in the aorta dislodge, they can be captured by the protective umbrella 11, which is attached to the vessel wall VW.

[0139] Combination Figure 17 As shown, by moving the first sheath assembly 10 proximally relative to the umbrella protection assembly 30, the first sheath tube 12 can drive the protective umbrella 11 back along the second sheath assembly 20 into the lumen of the inner constraint member 31. Thus, by simultaneously withdrawing the first sheath assembly 10 and the umbrella protection assembly 30 proximally relative to the second sheath assembly 20, the plaque and thrombus captured by the protective umbrella 11 can be removed from the body.

[0140] In summary, the endovascular interventional surgical device 100 provided in this application provides a pathway for subsequent interventional instruments and enables the capture of thrombi and plaques within blood vessels throughout the procedure, thereby reducing the incidence of cerebral infarction.

[0141] It should be noted that, in the embodiments of this application, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0142] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0143] In this application, unless otherwise expressly specified and limited, the first feature being "on" or "below" the second feature may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium.

[0144] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0145] The above embodiments merely illustrate several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of this patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the inventive concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. An endovascular interventional surgical device, characterized in that, include: The first sheath assembly includes a protective umbrella and a first sheath tube, the protective umbrella being connected to the distal end of the first sheath tube; The protective umbrella has a compressed state and an inflated state, wherein the diameter of the protective umbrella in the inflated state is larger than the diameter in the compressed state; Second sheath assembly; The umbrella protection assembly is detachably connected to the proximal end of the second sheath assembly; The first sheath is axially movable and passes through the umbrella protection assembly, and can drive the umbrella to retract into the umbrella protection assembly. When the umbrella protection assembly is connected to the proximal end of the second sheath assembly, the first sheath can push the umbrella from the umbrella protection assembly to the second sheath assembly.

2. The endovascular interventional surgical device according to claim 1, characterized in that, The first sheath assembly further includes a first sheath seat, a sealing and clamping cap, and a first sealing ring. The first sheath seat is connected to the proximal end of the first sheath tube, the sealing and clamping cap is connected to the first sheath seat, and the first sealing ring is disposed inside the first sealing and clamping cap. The first sealing ring is used to seal the connection position between the sealing and clamping cap and the first sheath seat.

3. The endovascular interventional surgical device according to claim 1 or 2, characterized in that, The first sheath includes an inner layer and an outer layer sleeved on the inner layer; the proximal end of the protective umbrella is embedded in the outer layer, or the proximal end of the protective umbrella is sandwiched between the inner layer and the outer layer.

4. The endovascular interventional surgical device according to claim 3, characterized in that, The protective umbrella includes a woven mesh and multiple wire end restraints. The woven mesh is made of metal wires, and the metal wires are led out from the far end of the woven mesh to form an outlet end. The multiple wire end restraints are connected to the outlet end.

5. The endovascular interventional surgical device according to claim 4, characterized in that, The protective umbrella includes a developing tube disposed on the woven mesh. The developing tube is sleeved on the head end of the metal wire and is woven synchronously with the corresponding metal wire. The material of the developing tube is platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy, barium sulfate, bismuth trioxide, or tungsten.

6. The endovascular interventional surgical device according to claim 4, characterized in that, The material of the thread restraint is platinum-iridium alloy, platinum-tungsten alloy, platinum-nickel alloy, barium sulfate, bismuth trioxide, or tungsten.

7. The endovascular interventional surgical device according to claim 1, characterized in that, The second sheath assembly includes a second sheath tube, a second sheath seat, a clamping member, and a second sealing ring. The second sheath seat is connected to the proximal end of the second sheath tube, the clamping member is connected to the second sheath seat, and the second sealing ring abuts against the proximal end face of the second sheath seat via the clamping member.

8. The endovascular interventional surgical device according to claim 7, characterized in that, The umbrella protection assembly includes an inner cavity constraint and a positioning member. The inner cavity constraint has a cavity extending through it along its axial direction. The positioning member is movably connected to the inner cavity constraint and is detachably connected to the clamping member.

9. The endovascular interventional surgical device according to claim 8, characterized in that, The clamping member includes a locking part, and the positioning member includes a first snap-fit ​​part. The positioning member can move to a locked position and an unlocked position relative to the inner cavity constraint member. When the positioning member is in the unlocked position, it can move distally relative to the second sheath seat so that the first engaging portion is opposite to the locking portion; and when the positioning member switches from the unlocked position to the locked position, the first engaging portion engages with the locking portion and locks the positioning member axially to the clamping member; when the positioning member switches from the locked position to the unlocked position, the first engaging portion and the locking portion are unlocked, and the inner cavity constraint member can move proximally relative to the second sheath seat to separate from the second sheath seat.

10. The endovascular interventional surgical device according to claim 9, characterized in that, The positioning element is rotatably connected to the outer periphery of the inner cavity constraint element, and the positioning element switches between the locked position and the unlocked position by rotating about the axial direction of the inner cavity constraint element.

11. The endovascular interventional surgical device according to claim 10, characterized in that, The positioning member includes a main body and a rotating connecting part connected to each other. The main body forms a receiving cavity. The first snap-fit ​​part is disposed on the inner wall of the receiving cavity. The rotating connecting part is rotatably engaged with the inner cavity constraint member. The locking part includes a guide groove and a limiting groove that are connected to each other. The guide groove extends from the limiting groove and penetrates the proximal end face of the clamping member. The limiting groove extends along the circumference of the clamping member. The guide groove is used to guide the first snap-fit ​​part to move to be opposite to the limiting groove. When the first snap-fit ​​part moves to be opposite to the limiting groove, the positioning member rotates about the axial direction of the inner cavity constraint member, and the first snap-fit ​​part moves from the guide groove to the limiting groove.

12. The endovascular interventional surgical device according to claim 11, characterized in that, The inner cavity constraint has a guide portion, and a portion of the lumen of the inner cavity constraint is formed in the guide portion; an annular space is formed between the guide portion and the inner wall of the receiving cavity; when the positioning member and the clamping member cooperate, the proximal end of the clamping member enters the annular space, and the guide portion is inserted into the second sheath.

13. The endovascular interventional surgical device according to claim 12, characterized in that, The distal end of the guide extends beyond the distal end of the positioning member.

14. The endovascular interventional surgical device according to claim 9, characterized in that, The endovascular interventional surgical device includes a dilator that can be inserted through the proximal end of the second sheath assembly into the second sheath assembly, and the dilator is axially movable relative to the second sheath assembly.

15. The endovascular interventional surgical device according to claim 14, characterized in that, The expander includes an expansion tube and a connector, the connector being connected to the proximal end of the expansion tube; the connector includes a second snap-fit ​​portion for detachably connecting to the locking portion.

16. The endovascular interventional surgical device according to claim 15, characterized in that, The connector includes a sleeve portion and an interface portion. The interface portion is connected to the proximal end of the sleeve portion, and the inner cavity of the interface portion communicates with the sleeve portion. The proximal end of the expansion tube extends into the sleeve portion and communicates with the inner cavity of the interface portion. The second snap-fit ​​portion is provided on the inner wall of the sleeve portion.

17. The endovascular interventional surgical device according to any one of claims 8-16, characterized in that, The umbrella protection assembly includes a locking nut and a third sealing ring. The locking nut is threaded to the proximal end of the inner cavity constraint member, and the third sealing ring is used to seal the connection position between the locking nut and the inner cavity constraint member.

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