In-situ fenestration and membrane puncture device for covered stent and puncture and membrane dilation integrated guide wire

Abstract

The present invention provides an in-situ fenestration and membrane puncture device for a covered stent and a combined puncture and membrane dilation guide wire, which relates to the field of medical devices and includes a combined puncture and membrane dilation guide wire and a quick-release handle; the combined puncture and membrane dilation guide wire includes an inner guide wire, a push tube, and a membrane dilation support mesh; the inner guide wire includes a core wire and a variable-diameter winding spring; the core wire passes through the push tube; by axially sliding the proximal main handle and the distal main handle relative to each other, the support wire frame radially expands or radially contracts on the core wire. The present invention can improve the positioning accuracy of the guide wire at the fenestration and membrane puncture point of the covered stent and quickly puncture the membrane, and can simultaneously ream the puncture hole. At the same time, it can alternately insert multiple instruments with a single insertion of the guide wire, achieving the effects of simplifying the surgical procedure, improving the surgical efficiency, and reducing the damage to the patient during the operation.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a device for in-situ fenestration and membrane rupture of a covered stent and a combined puncture and membrane dilation guide wire. Background Art

[0002] Aortic diseases, as common diseases in the spectrum of cardiovascular diseases, have a rapidly increasing incidence rate. Such as aortic aneurysm, atherosclerosis, aortic dissection, aortic ulcer, etc. These diseases greatly endanger human health and even threaten life. For aortic aneurysm, implanting a covered stent into the blood vessel to reconstruct the blood vessel has the advantages of small risk, less trauma, quick recovery, and simplified surgical procedures. Through femoral artery incision or puncture, the covered stent is implanted into the aneurysm, and the normal arteries at the proximal and distal ends of the aneurysm are connected by the covered stent. The arterial blood flow no longer fills the aneurysm body, and the aortic aneurysm body will gradually thrombose, thus playing a role in isolating the aortic aneurysm.

[0003] Since the aorta has many important branch blood vessels, such as the subclavian artery, celiac trunk, renal artery, mesenteric artery, etc., these branch blood vessels supply blood to important organs of the body. Therefore, when certain aortic aneurysms involve these important branch blood vessels, directly isolating the aortic aneurysm with a covered stent will also cover these important branch blood vessels, resulting in insufficient blood supply to important organs. In this regard, it is necessary to adopt the aortic aneurysm stent fenestration technique (pre-fenestration and in-situ fenestration), that is, accurately positioning on the covered stent, calculating the position of the important branch blood vessels, and removing the membrane on this part of the covered stent to ensure that after the covered stent is implanted, the blood supply of the important branch blood vessels can be ensured through the fenestration on the covered stent. Due to the differences in the lesion location, blood vessel size, and branch location of aortic aneurysm patients, the in-situ fenestration technique is preferably adopted among the two fenestration techniques of pre-fenestration and in-situ fenestration.

[0004] In the prior art, the in-situ fenestration technique generally uses imaging equipment to perform angiography imaging on the lesion site. Under the guidance of the imaging equipment, medical staff locate the opening site of the branch blood vessel, introduce a sheath from the femoral artery or brachial artery into the aorta, send a guiding catheter with different tip angles along the sheath, align the tip of the guiding catheter with the branch opening angle, send a guide wire along the guiding catheter to pierce the membrane of the position on the covered stent that needs to be fenestrated, then withdraw the guiding catheter, and then lower a balloon catheter for dilation along the guide wire for dilation treatment, so as to complete the in-situ fenestration. Performing in-situ fenestration on an aortic covered stent has high requirements for interventional instruments, and it is necessary to cooperate with instruments such as an adjustable bend sheath, an adjustable bend catheter, and a puncture needle membrane rupture device. Using membrane rupture instruments such as in-situ fenestration needles and lasers has high requirements for the intraoperative operation and judgment ability of the operator.

[0005] The existing in-situ fenestration technique has at least the following problems:

[0006] (1) The guide wires used in the prior art are general guide wires. Problems often occur that after the guide wire is positioned, it is difficult for the tip to pierce the film, and the guide wire has no effective support and positioning in the guiding sheath tube or the supporting point force is weak, resulting in inaccurate positioning. To solve these problems, it is necessary to replace the guide wire and repeatedly debug, which not only makes the operation complex, but also prolongs the operation time and increases the surgical risk.

[0007] (2) After successful puncture and membrane rupture in situ, how to bring the membrane dilation balloon to complete the membrane dilation is also a major problem in the prior art. The main difficulties are as follows: The opening of the membrane rupture point is much smaller than the tip of the balloon catheter. Therefore, when the balloon enters along the guide wire after membrane rupture, the tip of the balloon catheter is likely to be stuck and unable to pass when it contacts the film. To solve this problem, the current response method of doctors is to shape the tip of the balloon catheter by cutting, squeezing, etc. and then insert it. However, such an operation damages the tip of the balloon catheter, which will affect the fluidity of the balloon catheter inside the blood vessel, and may also cause damage to the blood vessel by the tip of the catheter when inserting and removing the balloon catheter, or the risk of introducing foreign bodies and causing thrombosis when inserting. In addition, the operation of shaping the tip of the balloon catheter on site also increases the operation time and surgical risk.

[0008] (3) In the prior art, due to the thin and soft guide wire, it is difficult to assemble with the existing operating handle in a detachable manner. Therefore, there are mainly two ways to push and pull the puncture guide wire:

[0009] ① The operator directly holds the proximal (rear) section of the guide wire to push and pull the guide wire. When pushing and pulling in this way, it is inconvenient for the operator to pinch the thin guide wire, and it is even more impossible to lock between the guide wire and other instruments (such as balloon catheters) inserted along the guide wire, and inaccurate positioning is likely to occur.

[0010] ② A guide wire handle is fixedly connected to the proximal (rear) end of the guide wire; in this way, when inserting the instrument, due to the obstruction of the guide wire handle, it is impossible to first insert the guide wire and then insert the instrument. Only the instrument can be first sleeved on the guide wire from the distal end of the guide wire to the proximal end, and then the instrument is inserted while inserting the guide wire. Before withdrawing the instrument inserted along the guide wire, it is necessary to first withdraw the guide wire out of the patient's body and then withdraw the instrument. When replacing other instruments, it is also necessary to withdraw the guide wire and then re-sleeve the replaced instrument on the guide wire from the distal end of the guide wire to the proximal end, and then insert the new instrument while inserting the guide wire; there is also the problem of complicated and complex operation. Summary of the Invention

[0011] The purpose of the present invention is to provide a device for in-situ fenestration and membrane rupture of a covered stent and a puncture and membrane dilation two-in-one guide wire to alleviate the above technical problems.

[0012] To achieve the above purpose, the embodiments of the present invention adopt the following technical solutions:

[0013] In a first aspect, an in-situ fenestration and membrane puncture device for a covered stent according to an embodiment of the present invention includes a puncture and membrane dilation integrated guide wire and a quick-release handle;

[0014] The puncture and membrane dilation integrated guide wire includes an inner guide wire, a push tube, and a membrane dilation support mesh;

[0015] The inner guide wire includes a core wire and a variable-diameter winding spring; the core wire passes through the push tube, the variable-diameter winding spring is wound around the outer portion of the distal segment of the core wire, and the distal end of the variable-diameter winding spring is fixedly connected to the distal end of the core wire; the variable-diameter winding spring includes a proximal large-diameter winding spring tube segment, a middle variable-diameter winding spring tube segment, and a distal small-diameter winding spring tube segment that are sequentially connected along the axial direction of the core wire; the membrane dilation support mesh includes a support wire frame, the support wire frame is sleeved on the outer portion of the part of the core wire located on the proximal side of the variable-diameter winding spring and can axially slide relative to the core wire; the proximal end of the support wire frame is fixedly connected to the distal end of the push tube, and the distal end of the support wire frame is fixedly connected to the proximal end of the proximal large-diameter winding spring tube segment;

[0016] The quick-release handle includes a proximal handle assembly, a distal handle assembly, and a locking assembly;

[0017] The distal handle assembly includes a distal main handle having an axial through hole; the proximal end of the push tube is detachably connected to the distal main handle;

[0018] The proximal handle assembly includes a proximal main handle having an axial through hole and a positioning mechanism installed on the proximal main handle; the proximal main handle is disposed on the proximal side of the distal main handle, the core wire passes through the axial through hole of the proximal main handle, the axial through hole of the distal main handle, and the push tube, and the positioning mechanism can position or release the core wire in the proximal main handle;

[0019] The locking assembly is installed on the proximal main handle and / or the distal main handle and is used to lock or unlock the proximal main handle to the distal main handle;

[0020] Axially sliding the proximal main handle and the distal main handle relative to each other can radially expand or radially contract the support wire frame on the core wire.

[0021] The usage method and effect of the in-situ fenestration and membrane puncture system for the aortic covered stent provided in this embodiment are as follows:

[0022] Before use, sleeved the push tube on the outside of the core wire, and connect the proximal end of the push tube to the distal main handle; pass the core wire in the proximal direction through the axial through hole of the distal main handle and the axial through hole of the proximal main handle, and use the positioning mechanism to position the core wire in the proximal main handle; axially slide the proximal main handle and the distal main handle relative to each other to radially contract the support wire frame on the core wire, and then use the locking assembly to lock the proximal main handle to the distal main handle;

[0023] Then, under percutaneous puncture, a guide wire is inserted into the branch vessel of the aorta where in-situ fenestration is to be performed until the lesion site. A guiding sheath is inserted along the guide wire, and then the guide wire is withdrawn. The pusher tube of this embodiment is inserted into the guiding sheath, and the guiding sheath is adjusted so that the distal end of the core wire of this embodiment is close to perpendicular to the membrane of the aortic covered stent for in-situ fenestration.

[0024] During this process, the core wire is positioned at the proximal main handle by the positioning mechanism, and the proximal main handle and the distal main handle are locked together by the locking assembly. The core wire can be operated by holding the proximal main handle and / or the distal main handle of the quick-release handle, which is easier for the operator to hold and more convenient to operate.

[0025] After that, in the first step, hold the quick-release handle and push the core wire distally, so that the distal end of the core wire pierces through the membrane of the aortic covered stent until the support wire frame enters or passes through the puncture hole punctured by the distal end of the core wire on the membrane.

[0026] During this process, since the distal segment of the core wire is externally wrapped with a variable-diameter winding spring, the structural strength of the distal end of the core wire is enhanced, and thus the membrane can be easily and quickly pierced. And there is a certain amount of elasticity between the coils of the variable-diameter winding spring, so that the distal structure of the core wire is not too hard (still has a certain flexibility) to meet the delivery requirements of the core wire inside the blood vessel. In addition, since the variable-diameter winding spring includes a proximal large-diameter winding spring tube section, a middle variable-diameter winding spring tube section, and a distal small-diameter winding spring tube section; the distal end of the distal small-diameter winding spring tube section is fixedly connected to the distal end of the core wire, and the support wire frame is sleeved outside the part of the core wire on the proximal side of the variable-diameter winding spring. Thus, a tapered reduced-diameter inclined surface with a gradually decreasing diameter from proximal to distal is formed at the junction of the middle variable-diameter winding spring tube section and the distal small-diameter winding spring tube section. This tapered reduced-diameter inclined surface can quickly guide the proximal large-diameter winding spring tube section and the support wire frame through the puncture hole to initially expand the puncture hole after the distal end of the core wire punctures a puncture hole in the membrane.

[0027] In the second step, axially slide the proximal main handle and the distal main handle relative to each other to radially expand the support wire frame, and the puncture hole can be further expanded by the expanded support wire frame.

[0028] After the above operations are completed, use the locking component to unlock the proximal main handle from the distal main handle, release the positioning of the core wire by the positioning mechanism, disconnect the proximal main handle and the distal main handle from the proximal ends of the core wire and the push tube, remove the quick-release handle, and axially slide the core wire and the push tube relative to each other to radially contract the support wire frame. During this process, since the core wire is positioned by the positioning mechanism at the proximal main handle, the proximal end of the push tube is detachably connected to the distal main handle, and a locking component is provided between the proximal main handle and the distal main handle. Thus, the proximal main handle and the distal main handle can be respectively detached from the core wire and the push tube under the condition of non-interference with each other; then, the puncture and membrane-breaking two-in-one guide wire can be further inserted into the branch covered stent or other subsequent instruments for treatment, thereby simplifying the surgical procedure and improving the surgical efficiency.

[0029] In summary, the covered stent in-situ fenestration and membrane-breaking system provided by the embodiment of the present invention can improve the positioning accuracy of the guide wire at the fenestration and membrane-breaking point of the covered stent and quickly break the membrane during the in-situ fenestration operation of the covered stent, and can simultaneously ream the puncture hole. At the same time, it can alternately insert multiple instruments by inserting the guide wire (core wire) once, achieving the effects of simplifying the surgical procedure, improving the surgical efficiency, and reducing the damage to the patient during the operation.

[0030] For more specific structural details of the covered stent in-situ fenestration and membrane-breaking device, reference can be made to the detailed description in the specific implementation part of this specification.

[0031] In a second aspect, the embodiment of the present invention provides a puncture and membrane-reaming two-in-one guide wire, which is applied to the covered stent in-situ fenestration and membrane-breaking device described in any one of the foregoing embodiments.

[0032] The puncture and membrane-reaming two-in-one guide wire includes an inner guide wire, a push tube, and a membrane-reaming support net;

[0033] The inner guide wire includes a core wire and a variable-diameter winding spring; the core wire passes through the push tube, the variable-diameter winding spring is wound around the outer part of the distal section of the core wire, and the distal end of the variable-diameter winding spring is fixedly connected to the distal end of the core wire; the variable-diameter winding spring includes a proximal large-diameter winding spring tube section, a middle variable-diameter winding spring tube section, and a distal small-diameter winding spring tube section that are sequentially connected along the axial direction of the core wire;

[0034] The membrane-reaming support net includes a support wire frame, the support wire frame is sleeved outside the part of the core wire on the proximal side of the variable-diameter winding spring and can axially slide relative to the core wire; the proximal end of the support wire frame is fixedly connected to the distal end of the push tube, and the distal end of the support wire frame is fixedly connected to the proximal end of the proximal large-diameter winding spring tube section.

[0035] For the effects that the puncture and membrane-reaming two-in-one guide wire provided by the embodiment of the present invention can achieve, reference can be made to the covered stent in-situ fenestration and membrane-breaking device provided in the first aspect.

[0036] In particular, in each embodiment of the present invention, "and / or" means that among the first feature before "and / or" and the second feature after "and / or", the following specific setting methods are included: (1) only the first feature is set, and the second feature is not set; (2) only the second feature is set, and the first feature is not set; (3) the first feature and the second feature are set simultaneously. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0038] Figure 1 FIG. is a schematic diagram of the overall structure of the in-situ fenestration and membrane rupture device for a covered stent provided by an embodiment of the present invention, wherein the puncture and membrane dilation two-in-one guide wire is the first optional structure;

[0039] Figure 2 is Figure 1 a partial enlarged view of area A in;

[0040] Figure 3 is Figure 1 a partial enlarged view of area B in;

[0041] Figure 4 FIG. is a schematic diagram of the distal region of the second optional structure of the puncture and membrane dilation two-in-one guide wire in the in-situ fenestration and membrane rupture device for a covered stent provided by an embodiment of the present invention;

[0042] Figure 5 FIG. is a schematic diagram of the overall structure of the quick-release handle in the in-situ fenestration and membrane rupture device for a covered stent provided by an embodiment of the present invention.

[0043] Icons: 100 - Quick-release handle; 110 - Proximal handle assembly; 1 - Proximal main handle; 11 - Limiting flange; 111 - Blocking protrusion; 12 - Proximal Luer connector; 2 - Positioning mechanism; 21 - Positioning handle part; 210 - Serrated protrusion; 211 - Pressing block; 2111 - First limiting post; 212 - Pressing rod; 2121 - Extension part; 22 - First spring; 23 - Hose; 3 - Limiting assembly; 31 - Second spring; 32 - Limiting handle part; 320 - Serrated groove; 321 - Second limiting post; 120 - Distal handle assembly; 121 - Distal main handle; 1211 - Second Luer connector; 1212 - First limiting flange; 1213 - Second limiting flange; 1214 - First magnetic part; 1215 - Second magnetic part; 130 - Locking assembly; 131 - Middle sleeve; 1310 - Thread groove; 132 - Push-pull handle part; 133 - Elastic pressing strip; 1331 - Pressing protrusion; 1332 - Limiting protrusion;

[0044] 41 - Core wire; 42 - Variable-diameter winding spring; 421 - Proximal large-diameter winding spring tube section; 422 - Middle variable-diameter winding spring tube section; 423 - Distal small-diameter winding spring tube section; 5 - Pushing tube; 501 - First Luer connector; 51 - Pushing main tube; 52 - Winding spring tube; 6 - Film expansion support net; 61 - Support grid frame; 62 - Inner support assembly; 621 - Connecting block; 622 - Limiting block; 623 - Connecting wire; 7 - Guide head; 8 - Developing ring; 9 - Sleeve connector. Detailed implementation manners

[0045] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. Usually, the components of the embodiments of the present invention described and shown in the accompanying drawings here can be arranged and designed in various different configurations.

[0046] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed present invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0047] It should be noted that: Similar reference numerals and letters denote similar items in the drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0048] In the description of the present invention, it should be noted that:

[0049] Unless otherwise clearly specified and defined, the terms "arranged", "installed", and "connected" shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be directly connected or indirectly connected through an intermediate medium, and it may be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0050] The orientation or positional relationship indicated by the terms "proximal end", "distal end", "front end", "rear end", "axial direction", "radial direction", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the invention product is usually placed during use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention.

[0051] The terms "first", "second", etc. are only used for distinguishing descriptions, do not represent a total number, or a relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0052] Hereinafter, taking the end of the medical device close to the operator during the operation as the proximal end of the medical device, and the end of the medical device entering the patient's blood vessel as the distal end of the medical device (the front end of the medical device is the distal end, and the rear end of the medical device is the proximal end), some embodiments of the present invention will be described in detail with reference to the drawings.

[0053] Embodiment 1

[0054] This embodiment provides a device for in-situ fenestration and membrane rupture of a covered stent. Referring to Figures 1 to 5 , the device for in-situ fenestration and membrane rupture of the covered stent includes a puncture and membrane dilation combined guide wire and a quick-release handle 100.

[0055] Specifically, the puncture and membrane dilation combined guide wire includes an inner guide wire, a push tube 5, and a membrane dilation support mesh 6. The inner guide wire includes a core wire 41 and a variable-diameter winding spring 42; the core wire 41 passes through the push tube 5, and the variable-diameter winding spring 42 is wound around the outer part of the distal segment of the core wire 41, and the distal end of the variable-diameter winding spring 42 is fixedly connected to the distal end of the core wire 41; the variable-diameter winding spring 42 includes a proximal large-diameter winding spring tube section 421, a middle variable-diameter winding spring tube section 422, and a distal small-diameter winding spring tube section 423 that are sequentially connected along the axial direction of the core wire 41; the membrane dilation support mesh 6 includes a support grid 61, and the support grid 61 is sleeved on the outer part of the part of the core wire 41 on the proximal side of the variable-diameter winding spring 42 and can axially slide relative to the core wire 41; the proximal end of the support grid 61 is fixedly connected to the distal end of the push tube 5, and the distal end of the support grid 61 is fixedly connected to the proximal end of the proximal large-diameter winding spring tube section 421.

[0056] The quick-release handle 100 includes a proximal handle assembly 110, a distal handle assembly 120, and a locking assembly 130. The distal handle assembly 120 includes a distal main handle 121 having an axial through-hole; the proximal end of the push tube 5 is detachably connected to the distal main handle 121. The proximal handle assembly 110 includes a proximal main handle 1 having an axial through-hole and a positioning mechanism 2 mounted on the proximal main handle 1; the proximal main handle 1 is disposed on the proximal side of the distal main handle 121, and the core wire 41 passes through the axial through-hole of the proximal main handle 1, the axial through-hole of the distal main handle 121, and the push tube 5, and the positioning mechanism 2 can position or release the core wire 41 in the proximal main handle 1. The locking assembly 130 is mounted on the proximal main handle 1 and / or the distal main handle 121 for locking or unlocking the proximal main handle 1 to the distal main handle 121. Axially sliding the proximal main handle 1 and the distal main handle 121 relative to each other can radially expand or radially contract the support wire frame 61 relative to the core wire 41.

[0057] The usage method and effect of the in-situ fenestration and membrane rupture system of the aortic covered stent provided in this embodiment are as follows:

[0058] Before use, the push tube 5 is sleeved outside the core wire 41, and the proximal end of the push tube 5 is connected to the distal main handle 121; the core wire 41 is passed through the axial through-hole of the distal main handle 121 and the axial through-hole of the proximal main handle 1 in the proximal direction, and the core wire 41 is positioned in the proximal main handle 1 by using the positioning mechanism 2; the proximal main handle 1 and the distal main handle 121 are axially slid relative to each other to radially contract the support wire frame 61 relative to the core wire 41, and then the proximal main handle 1 is locked to the distal main handle 121 by using the locking assembly 130;

[0059] Then, under percutaneous puncture, a guide wire is inserted into the branch vessel of the aorta to be fenestrated in situ to the lesion site, a guiding sheath tube is inserted along the guide wire, and then the guide wire is withdrawn. The push tube 5 of this embodiment is inserted into the guiding sheath tube, and the guiding sheath tube is adjusted so that the distal end of the core wire 41 of this embodiment is close to perpendicular to the membrane of the aortic covered stent to be fenestrated in situ;

[0060] During this process, the core wire 41 is positioned in the proximal main handle 1 by the positioning mechanism 2, and the proximal main handle 1 and the distal main handle 121 are locked together by the locking assembly 130. The core wire 41 can be operated by holding the proximal main handle 1 and / or the distal main handle 121 of the quick-release handle 100, which is easier for the operator to hold and more convenient to operate;

[0061] After that, in the first step, hold the quick-release handle 100 and push the core wire 41 distally so that the distal end of the core wire 41 pierces the membrane of the aortic covered stent until the support wire frame 61 enters or passes through the puncture hole punctured by the distal end of the core wire 41 in the membrane;

[0062] During this process, since the distal segment of the core wire 41 is externally wrapped with a variable-diameter winding spring 42, the structural strength of the distal end of the core wire 41 is enhanced, enabling the membrane to be easily and quickly broken. Moreover, there is a certain amount of elasticity between the coils of the variable-diameter winding spring 42, so that the distal structure of the core wire 41 is not too rigid (still having a certain flexibility) to meet the delivery requirements of the core wire 41 inside the blood vessel. In addition, since the variable-diameter winding spring 42 includes a proximal large-diameter winding spring tube segment 421, a middle variable-diameter winding spring tube segment 422, and a distal small-diameter winding spring tube segment 423; the distal end of the distal small-diameter winding spring tube segment 423 is fixedly connected to the distal end of the core wire 41, and the support wire frame 61 is sleeved outside the part of the core wire 41 on the proximal side of the variable-diameter winding spring 42. Thus, a tapered reduced-diameter inclined surface with a gradually decreasing diameter from the proximal end to the distal end is formed at the junction of the middle variable-diameter winding spring tube segment 422 and the distal small-diameter winding spring tube segment 423. This tapered reduced-diameter inclined surface can quickly guide the proximal large-diameter winding spring tube segment 421 and the support wire frame 61 through the puncture hole to initially expand the puncture hole after the distal end of the core wire 41 punctures a puncture hole in the film.

[0063] In the second step, axially slide the proximal main handle 1 and the distal main handle 121 relatively to radially expand the support wire frame 61, and the puncture hole can be further expanded through the expanded support wire frame 61.

[0064] After the above operations are completed, use the locking assembly 130 to unlock the proximal main handle 1 from the distal main handle 121, release the positioning of the core wire 41 by the positioning mechanism 2, disconnect the proximal main handle 1 and the distal main handle 121 from the proximal ends of the core wire 41 and the push tube 5, remove the quick-release handle 100, and axially slide the core wire 41 and the push tube 5 relatively to radially contract the support wire frame 61. During this process, since the core wire 41 is positioned by the positioning mechanism 2 on the proximal main handle 1, the proximal end of the push tube 5 is detachably connected to the distal main handle 121, and a locking assembly 130 is provided between the proximal main handle 1 and the distal main handle 121. Thus, the proximal main handle 1 and the distal main handle 121 can be respectively detached from the core wire 41 and the push tube 5 without interfering with each other; then, the branch covered stent or other subsequent instruments for treatment can be further inserted through this puncture and membrane-breaking combined guide wire, thereby simplifying the surgical procedure and improving the surgical efficiency.

[0065] In summary, the covered stent in-situ fenestration and membrane-breaking system provided in this embodiment can improve the positioning accuracy of the guide wire at the fenestration and membrane-breaking point of the covered stent and quickly break the membrane during the covered stent in-situ fenestration surgery, and can simultaneously expand the puncture hole. At the same time, it can realize single-time insertion of the guide wire (core wire 41) and alternately insert multiple instruments, achieving the effects of simplifying the surgical procedure, improving the surgical efficiency, and reducing the damage to the patient during the surgical process.

[0066] There are multiple optional implementation manners for the specific structure of the membrane-expanding support net 6 in this embodiment. For example, in one optional implementation manner, asFigure 3 As shown, the membrane expansion support net 6 includes a support network frame 61 and at least one group (preferably but not limited to two groups as shown in Figure 3 ) of inner support components 62 disposed inside the support network frame 61. The support network frame 61 is sleeved outside the portion of the core wire 41 on the proximal side of the variable-diameter winding spring 42 and can axially slide relative to the core wire 41; the proximal end of the support network frame 61 is fixedly connected to the distal end of the push tube 5, and the distal end of the support network frame 61 is fixedly connected to the proximal end of the proximal large-diameter winding spring tube section 421. Each group of inner support components 62 respectively includes a connection block 621, a limit block 622, and multiple connection wires 623; wherein, the connection block 621 is sleeved outside the portion of the core wire 41 on the proximal side of the variable-diameter winding spring 42 and can axially slide relative to the core wire 41; the multiple connection wires 623 are circumferentially spaced apart around the core wire 41, and one end of each connection wire 623 is fixedly connected to the connection block 621 and the other end is fixedly connected to the support network frame 61; the limit block 622 is fixedly connected to the core wire 41 and is located on the distal side of the connection block 621.

[0067] As Figure 3 shown, in this alternative embodiment, when the core wire 41 is retracted proximally relative to the push tube 5, the distal end of the push tube 5 (the proximal end of the support network frame 61) remains stationary, and the distal end of the core wire 41 drives the support network frame 61 to slide proximally, causing the connection block 621 to slide distally along the core wire 41. During the sliding process, the multiple connection wires 623 connected to the connection block 621 expand radially along the core wire 41, and thus the support network frame 61 will be radially expanded along the core wire 41. Moreover, during the process, due to the provision of the limit block 622, it is possible to prevent the connection block 621 from sliding excessively to the axially opposite side, causing the support network frame 61 to change from a radially expanded state to a radially contracted state; the operator can control the degree of retraction of the core wire 41 relative to the push tube 5 proximally according to the degree of reaming required for the puncture hole, so as to control the radial expansion degree of the support network frame 61, and further control the range of the reaming diameter of the puncture hole. When the reaming is completed, by pushing the core wire 41 distally relative to the push tube 5, the support network frame 61 can be restored to a state of being radially contracted around the core wire 41. In this embodiment, the connection block 621 is preferably connected to the core wire 41 in a friction fit manner to further increase the positioning ability between the two. However, those skilled in the art should understand that since the axial relative positioning between the core wire 41 and the push tube 5 is achieved, the positions of the support network frame 61 relative to both ends of the core wire 41 are fixed, and the support network frame 61 can be maintained in a radially expanded state. Therefore, the aforementioned connection block 621 is preferably connected to the core wire 41 in a friction fit manner, which is not a necessary setting condition for the assembly relationship between the connection block 621 and the core wire 41, but only a more preferred condition set for this alternative embodiment to increase the stability of the support network frame 61 in the expanded state.

[0068] Also, for example, in another alternative embodiment, as Figure 4As shown, the membrane expansion support mesh 6 is a separate mesh structure. However, for this structure, it is necessary to select a mesh with an appropriate density according to the diameter range of the puncture hole that needs to be expanded before the operation, that is, it is necessary to prepare puncture and membrane expansion two-in-one guide wires of various specifications.

[0069] In addition, in order to improve the smoothness of the guide wire when entering and exiting the puncture hole formed after the membrane of the aortic endovascular stent is punctured as much as possible during use, in an alternative embodiment of the present embodiment, regardless of which specific alternative structure of the membrane expansion support mesh 6 described above, the membrane expansion support mesh 6 is in a spindle shape with a cylindrical middle part and tapered ends in the axial direction in the radially expanded state, so as to facilitate the rapid entry and exit of the membrane expansion support mesh 6 through the puncture hole on the membrane in the radially expanded state, and further improve the surgical efficiency.

[0070] In addition, in an alternative embodiment of the present embodiment, the push tube 5 includes a push main tube 51 and a coiled tube 52; the coiled tube 52 is sleeved on the distal section of the push main tube 51, and both the proximal and distal ends of the coiled tube 52 are fixedly connected to the outer wall of the push main tube 51. More specifically, a sleeve joint 9 that is sleeved outside the core wire 41 and whose diameter gradually increases from the proximal end to the distal end is fixed at the distal end of the push main tube 51, and the proximal end of the coiled tube 52 is fixedly connected to the distal end of the sleeve joint 9; the proximal end of the membrane expansion support mesh 6 is fixedly connected to the coiled tube 52. The structure of this alternative embodiment can increase the structural strength of the push tube 5 through the coiled tube 52, further improve the stability of the membrane expansion support mesh 6 in the radially expanded state, and moreover, the outer peripheral surface of the sleeve joint 9 can be used as a tapered guiding surface to increase the smoothness of the coiled tube 52 entering and exiting the puncture hole on the membrane.

[0071] In some alternative embodiments of the present embodiment, the part of the core wire 41 located inside the variable-diameter coiled spring 42 has a shape that varies in diameter synchronously with the variable-diameter coiled spring 42.

[0072] In some alternative embodiments of the present embodiment, the inner guide wire further includes a guiding head 7, the distal ends of the variable-diameter coiled spring 42 and the core wire 41 are both connected to the guiding head 7, and the distal end face of the guiding head 7 is hemispherical or tapered with the tip facing the distal end; by providing the guiding head 7, it is possible to avoid the connection between the distal end of the distal small-diameter coiled tube section 423 and the distal end of the core wire 41 from stabbing the inner wall of the blood vessel during the transmission of the guide wire in the blood vessel.

[0073] In some alternative embodiments of the present embodiment, at least one of the two axial ends of the support grid 61, the outer wall of the proximal large-diameter coiled tube section 421, the proximal end of the distal small-diameter coiled tube section 423, and the distal end of the distal small-diameter coiled tube section 423 is fixedly connected with a radiopaque ring 8 to perform radiography and indicate each position under X-rays to help the surgeon perform the operation accurately.

[0074] In this embodiment, there are various specific detachable connection methods between the proximal end of the push tube 5 and the distal end of the distal main handle 121. Since the proximal main handle 1 and the distal main handle 121 can be locked or unlocked by the locking assembly 130, the distal main handle 121 and the proximal main handle 1 can move independently without interfering with each other. On this basis, the proximal end of the push tube 5 and the distal end of the distal main handle 121 can be screwed or plugged. Optionally, a first Luer connector 501 is provided at the proximal end of the push tube 5, and a second Luer connector 1211 is provided on the distal end face of the distal main handle 121, and the first Luer connector 501 is screwed to the second Luer connector 1211.

[0075] In this embodiment, the locking assembly 130 also has various alternative embodiments. For example, but not limited to, snap structures are provided at the distal end of the proximal main handle 1 and / or the proximal end of the distal main handle 121, and they are snap-connected to each other when the two are butted. However, this structure is not easy to operate and has a large amplitude when unlocking, which may cause injury to the patient. To increase the convenience and flexibility of operation and reduce the movement amplitude during unlocking to reduce the injury to the patient, in some alternative embodiments of this embodiment, the locking assembly 130 includes a middle sleeve 131, a push-pull handle member 132, and an elastic pressing strip 133; a side wall through hole communicating with the outer side wall of the distal main handle 121 and the axial through hole is also provided on the distal main handle 121; the elastic pressing strip 133 is axially arranged inside the axial through hole of the distal main handle 121, and the distal end of the elastic pressing strip 133 is fixedly connected to the inner wall of the axial through hole of the distal main handle 121; a pressing protrusion 1331 is provided on one surface of the elastic pressing strip 133 facing the outside of the side wall through hole of the distal main handle 121, and the pressing protrusion 1331 extends through the side wall through hole of the distal main handle 121 to the outside of the distal main handle 121; a limiting protrusion 1332 protruding radially inward along the distal main handle 121 is provided at the proximal end of the elastic pressing strip 133; the push-pull handle member 132 is sleeved outside the distal main handle 121 and can axially slide relative to the distal main handle 121. The proximal end of the middle sleeve 131 is rotatably connected to the proximal main handle 1, and moreover, the middle sleeve 131 is axially limited to the proximal main handle 1. The distal section of the middle sleeve 131 is inserted into the axial through hole of the distal main handle 121, and a threaded groove 1310 is provided on the outer peripheral surface of the distal section of the middle sleeve 131. Among them, the specific limiting connection method of "the proximal end of the middle sleeve 131 is rotatably connected to the proximal main handle 1, and moreover, the middle sleeve 131 is axially limited to the proximal main handle 1" includes but is not limited to, providing an extended connecting pipe section at the distal end of the proximal main handle 1, providing an annular protrusion extending circumferentially along the extended connecting pipe section on the outer peripheral surface of the extended connecting pipe section, and providing an annular groove extending circumferentially along the middle sleeve on the inner peripheral surface of the middle sleeve 131, so that the aforementioned annular protrusion is limited in the annular groove. For the convenience of assembly, the middle sleeve can be set to include two half shells cut axially, and these two half shells are then snap-connected to each other. The push-pull handle member 132 has a locking position and an unlocking position. When the distal main handle 121 is in the locking position, it is sleeved outside the pressing protrusion 1331, so that the limiting protrusion 1332 of the elastic pressing strip 133 is engaged with any threaded groove 1310 of the middle sleeve 131. When the distal main handle 121 is in the unlocking position, the pressing protrusion 1331 is released, and the limiting protrusion 1332 of the elastic pressing strip 133 is disengaged from the threaded groove 1310 of the middle sleeve 131. Under this structure, in addition to the basic function of locking and unlocking between the proximal main handle 1 and the distal main handle 121, the axial distance between the proximal main handle 1 and the distal main handle 121 can also be axially adjusted by rotating the middle sleeve 131 when the two are in the locked state, and the operation is more convenient.

[0076] To maintain the stability of the push-pull handle member 132 at the locked position and the unlocked position respectively, in this alternative embodiment, further optionally, a first limiting flange 1212 is provided on the proximal outer peripheral surface of the distal main handle 121, a first magnetic member 1214 is provided on the distal end surface of the first limiting flange 1212, a second limiting flange 1213 is provided on the distal outer peripheral surface of the distal main handle 121, and a second magnetic member 1215 is provided on the proximal end surface of the second limiting flange 1213; the push-pull handle member 132 is made of a material that can be attracted to the first magnetic member 1214 and the second magnetic member 1215 respectively, or a third magnetic member that can be attracted to the first magnetic member 1214 and the second magnetic member 1215 is provided on the push-pull handle member 132.

[0077] In addition, in this embodiment, in the proximal handle assembly 110, the positioning mechanism 2 also has various alternative structural types, but it needs to satisfy that the proximal segment of the thinner core wire 41 can be positioned or released on the inner wall of the axial through hole of the proximal main handle 1. For example, continuing to refer to Figure 5 In some alternative embodiments of this embodiment, the positioning mechanism 2 of the proximal handle assembly 110 includes a positioning handle member 21, a first spring 22, a rubber tube 23 and a limiting assembly 3. A side wall through hole communicating the outer side wall of the proximal main handle 1 and the axial through hole is further provided on the proximal main handle 1; the rubber tube 23 is inserted and fixed inside the axial through hole of the proximal main handle 1, and the core wire 41 passes through the rubber tube 23. The positioning handle member 21 includes a pressing block 211 and a pressing rod 212 connected to the pressing block 211; one end of the first spring 22 is connected to the pressing block 211 and the other end is connected to the outer wall of the proximal main handle 1; the pressing rod 212 passes through the side wall through hole of the proximal main handle 1; the positioning handle member 21 has a first working position and a second working position. When the positioning handle member 21 is in the first working position, the first spring 22 is compressed and the end of the pressing rod 212 away from the pressing block 211 presses inward on the rubber tube 23 along the radial direction of the proximal main handle 1. When the positioning handle member 21 is in the second working position, the first spring 22 rebounds to the free state and the end of the pressing rod 212 away from the pressing block 211 releases the rubber tube 23; the limiting assembly 3 is movably installed outside the proximal main handle 1, and the limiting assembly 3 can lock or release the positioning handle member 21 on the proximal main handle 1.

[0078] Among them, there are various alternative structures of the limiting assembly 3. For example, but not limited to, the limiting assembly 3 is as Figure 5The figure includes a second spring 31 and a limit handle member 32; the limit handle member 32 is arranged on one axial side of the proximal main handle 1, and the limit handle member 32 is rotatably installed on the proximal main handle 1 through a rotating shaft; the second spring 31 extends radially along the proximal main handle 1, and one end of the second spring 31 is fixedly connected to the limit handle member 32, and the other end is fixedly connected to the outer wall of the proximal main handle 1. A plurality of serrated grooves 320 are provided on one side surface of the limiting handle member 32 facing the positioning handle member 21 and are radially spaced apart along the proximal main handle 1; at least one serrated protrusion 210 is provided on one side surface of the positioning handle member 21 facing the limiting handle member 32; when the second spring 31 is in a free state, the serrated protrusion 210 is engaged with any serrated groove 320 to lock the positioning handle member 21 to the proximal main handle 1, and when the limiting handle member 32 is rotated in a direction away from the positioning handle member 21, the second spring 31 is compressed, the serrated protrusion 210 and the serrated groove 320 are disengaged from each other, and the positioning handle member 21 is unlocked.

[0079] To further increase stability, further optionally, a limiting flange 11 is further provided on the distal outer wall of the proximal main handle 1, and the limiting flange 11 is provided with a blocking protrusion 111 facing the proximal direction; an extension portion 2121 is provided on the side of the pressure rod 212 facing the limiting flange 11, and one end of the first spring 22 facing away from the outer wall of the proximal main handle 1 is fixedly connected to the extension portion 2121, and the extension portion 2121 is limited along the radial direction of the proximal main handle 1 between the blocking protrusion 111 and the outer wall of the proximal main handle 1.

[0080] To further increase the positioning reliability of the positioning mechanism 2, optionally, a first limiting column 2111 extending radially along the proximal main handle 1 is connected to the pressing block 211, and the first limiting column 2111 is inserted into the first spring 22; and / or, and / or, a second limiting column 321 is connected to the limiting handle member 32, and the second spring 31 is sleeved on the second limiting column 321. The second limiting column 321 should not be too long, otherwise it will prevent the limiting handle member 32 from flipping around its rotation axis.

[0081] To enhance the positioning effect of the core wire 41 , in some optional implementations of the present embodiment, the positioning mechanism 2 includes two groups symmetrically arranged radially opposite to each other on the proximal main handle 1 , so as to form an extrusion force on the core wire 41 on both sides of the rubber tube 23 that are symmetrical in the radial direction.

[0082] In addition, in this embodiment, a proximal Luer connector 12 may be provided at the proximal end of the proximal main handle 1 to cooperate with other auxiliary devices when in use.

[0083] Embodiment 2

[0084] This embodiment provides a puncture and membrane dilation integrated guide wire, which is applied to the in-situ fenestration and membrane puncture device of the covered stent provided by any optional implementation manner in Embodiment 1.

[0085] The puncture and membrane dilation integrated guide wire includes an inner guide wire, a push tube 5, and a membrane dilation support net 6. The inner guide wire includes a core wire 41 and a variable-diameter winding spring 42; the core wire 41 passes through the push tube 5, and the variable-diameter winding spring 42 is wound around the outer part of the distal section of the core wire 41, and the distal end of the variable-diameter winding spring 42 is fixedly connected to the distal end of the core wire 41; the variable-diameter winding spring 42 includes a proximal large-diameter winding spring tube section 421, a middle variable-diameter winding spring tube section 422, and a distal small-diameter winding spring tube section 423 that are sequentially connected along the axial direction of the core wire 41; the membrane dilation support net 6 includes a support wire frame 61, and the support wire frame 61 is sleeved outside the part of the core wire 41 on the proximal side of the variable-diameter winding spring 42 and can axially slide relative to the core wire 41; the proximal end of the support wire frame 61 is fixedly connected to the distal end of the push tube 5, and the distal end of the support wire frame 61 is fixedly connected to the proximal end of the proximal large-diameter winding spring tube section 421.

[0086] Finally, it should be noted that the above embodiments and their optional implementation manners in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing optional implementation manners, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that: without conflict, the features of the embodiments and the optional implementation manners in the embodiments in this specification can be combined with each other.

Claims

1. An in-situ fenestration and membrane rupture device for a stent graft, characterized in that: It includes a two-in-one puncture and membrane dilation guide wire and a quick-release handle (100); The two-in-one puncture and membrane expansion guide wire comprises an inner guide wire, a push tube (5) and a membrane expansion support net (6); The inner guide wire comprises a core wire (41) and a variable diameter coil spring (42); the core wire (41) passes through the push tube (5), the variable diameter coil spring (42) is wrapped around the outside of the distal end section of the core wire (41), and the distal end of the variable diameter coil spring (42) is fixedly connected to the distal end of the core wire (41); the variable diameter coil spring (42) comprises a proximal large diameter coil spring tube section (421), a middle variable diameter coil spring tube section (422) and a distal small diameter coil spring tube section (421) which are sequentially connected along the axial direction of the core wire (41). The membrane expansion support net (6) comprises a support grid (61), the support grid (61) is sleeved on the outside of the portion of the core wire (41) located on the proximal side of the variable diameter coil spring (42) and is capable of axially sliding relative to the core wire (41); the proximal end of the support grid (61) is fixedly connected to the distal end of the push tube (5), and the distal end of the support grid (61) is fixedly connected to the proximal end of the proximal large diameter coil spring tube section (421); The quick-release handle (100) comprises a proximal handle assembly (110), a distal handle assembly (120) and a locking assembly (130); The distal handle assembly (120) comprises a distal main handle (121) having an axial through hole; the proximal end of the push tube (5) is connected to the distal main handle (121) in a detachable manner; The proximal handle assembly (110) comprises a proximal main handle (1) having an axial through hole and a positioning mechanism (2) mounted on the proximal main handle (1); the proximal main handle (1) is arranged on the proximal side of the distal main handle (121); the core wire (41) passes through the axial through hole of the proximal main handle (1), the axial through hole of the distal main handle (121) and the pushing tube (5); the positioning mechanism (2) is capable of positioning or releasing the core wire (41) on the proximal main handle (1); The locking assembly (130) is mounted on the proximal main handle (1) and / or the distal main handle (121), and is used to lock or unlock the proximal main handle (1) to the distal main handle (121); Axially sliding the proximal main handle (1) and the distal main handle (121) relative to each other can cause the support grid (61) to radially expand or radially contract relative to the core wire (41).

2. The in situ fenestration and membrane rupture device for the stent graft according to claim 1, characterized in that: The membrane expansion support net (6) further comprises at least one group of inner support components (62) arranged inside the support net frame (61); Each group of the inner support components (62) comprises a connecting block (621), a limiting block (622) and a plurality of connecting wires (623); wherein the connecting block (621) is sleeved on the outside of a portion of the core wire (41) located on the proximal side of the variable diameter winding spring (42) and is capable of axially sliding relative to the core wire (41); the plurality of connecting wires (623) are circumferentially spaced around the core wire (41), and each of the connecting wires (623) has one end fixedly connected to the connecting block (621) and the other end fixedly connected to the supporting grid (61); the limiting block (622) is fixedly connected to the core wire (41) and is located on the distal side of the connecting block (621).

3. The in situ fenestration and membrane rupture device for the stent graft according to claim 1, characterized in that: The membrane expansion support net (6) is in a radially expanded state and is in a spindle shape with a cylindrical middle portion in the axial direction and conical ends.

4. The in situ fenestration and membrane rupture device for the stent graft according to claim 1, characterized in that: The push tube (5) comprises a push main tube (51) and a reed tube (52); the reed tube (52) is sleeved on the distal end section of the push main tube (51), and the proximal end and the distal end of the reed tube (52) are both fixedly connected to the outer wall of the push main tube (51), and the proximal end of the membrane expansion support net (6) is fixedly connected to the reed tube (52).

5. The in situ fenestration and membrane rupture device for the stent graft according to claim 1, characterized in that: The portion of the core wire (41) located inside the variable diameter coil spring (42) is in a shape that changes diameter synchronously with the variable diameter coil spring (42); And / or, the inner guide wire further comprises a guide head (7), the distal end of the variable diameter coil spring (42) and the distal end of the core wire (41) are both connected to the guide head (7), and the guide head (7) has a hemispherical distal end face or a conical shape with the tip facing the distal end.

6. The in situ fenestration and membrane rupture device for the stent graft according to claim 1, characterized in that: At least one of the two axial ends of the support grid (61), the outer wall of the proximal large-diameter reed tube section (421), the proximal end of the distal small-diameter reed tube section (423), and the distal end of the distal small-diameter reed tube section (423) is fixedly connected to a developing ring (8).

7. The in situ fenestration and membrane rupture device for the stent graft according to claim 1, characterized in that: The proximal end of the push tube (5) is provided with a first Luer connector (501), the distal end surface of the distal main handle (121) is provided with a second Luer connector (1211), and the first Luer connector (501) and the second Luer connector (1211) are screwed together; The locking assembly (130) comprises a middle sleeve (131), a push-pull handle (132) and an elastic pressure strip (133); The distal main handle (121) is also provided with a side wall through hole connecting the outer wall of the distal main handle (121) and the axial through hole; the elastic pressure strip (133) is arranged inside the axial through hole of the distal main handle (121) along the axial direction of the distal main handle (121), and the distal end of the elastic pressure strip (133) is fixedly connected to the inner wall of the axial through hole of the distal main handle (121); the elastic pressure strip (133) faces the outside of the side wall through hole of the distal main handle (121) A pressing protrusion (1331) is provided on one side surface of the distal main handle (121), and the pressing protrusion (1331) passes through the side wall through hole of the distal main handle (121) and extends to the outside of the distal main handle (121); a limiting protrusion (1332) protruding radially inward along the distal main handle (121) is provided at the proximal end of the elastic pressure strip (133); the push-pull handle member (132) is sleeved on the outside of the distal main handle (121) and can slide axially relative to the distal main handle (121); The proximal end of the middle sleeve (131) is rotatably connected to the proximal main handle (1), and the middle sleeve (131) is axially limited to the proximal main handle (1), the distal section of the middle sleeve (131) is inserted into the axial through hole of the distal main handle (121), and a thread groove (1310) is provided on the outer circumferential surface of the distal section of the middle sleeve (131); The push-pull handle member (132) has a locking position and an unlocking position. When the distal main handle (121) is in the locking position, it is sleeved outside the pressing protrusion (1331) so that the limiting protrusion (1332) of the elastic pressure strip (133) and any thread groove (1310) of the middle sleeve (131) are mutually engaged. When the distal main handle (121) is in the unlocking position, the pressing protrusion (1331) is released, and the limiting protrusion (1332) of the elastic pressure strip (133) is disengaged from the thread groove (1310) of the middle sleeve (131).

8. The in situ fenestration and membrane rupture device for the stent graft according to claim 1, characterized in that: In the proximal handle assembly (110), the positioning mechanism (2) comprises a positioning handle member (21), a first spring (22), a rubber hose (23) and a limit assembly (3); The proximal main handle (1) is also provided with a side wall through hole communicating with the outer side wall of the proximal main handle (1) and the axial through hole; the rubber tube (23) is passed through and fixed inside the axial through hole of the proximal main handle (1), and the core wire (41) passes through the rubber tube (23); The positioning handle member (21) comprises a pressing block (211) and a pressing rod (212) connected to the pressing block (211); one end of the first spring (22) is connected to the pressing block (211), and the other end is connected to the outer wall of the proximal main handle (1); the pressing rod (212) passes through a through hole in the side wall of the proximal main handle (1); the positioning handle member (21) has a first working position and a second working position, and when the positioning handle member (21) is in the first working position, the first spring (22) is compressed and the pressing rod (212) is in the first working position. The end facing away from the pressing block (211) is pressed radially inwardly along the proximal main handle (1) against the rubber hose (23). When the positioning handle member (21) is in the second position, the first spring (22) rebounds to a free state and the end of the pressing rod (212) facing away from the pressing block (211) releases the rubber hose (23). The limiting assembly (3) is movably mounted on the outside of the proximal main handle (1). The limiting assembly (3) can lock or release the positioning handle member (21) to the proximal main handle (1).

9. The in situ fenestration and membrane rupture device for the stent graft according to claim 8, characterized in that: The limiting assembly (3) comprises a second spring (31) and a limiting handle (32); The limit handle member (32) is arranged on one axial side of the proximal main handle (1), and the limit handle member (32) is rotatably mounted on the proximal main handle (1) via a rotating shaft; the second spring (31) extends radially along the proximal main handle (1), and one end of the second spring (31) is fixedly connected to the limit handle member (32), and the other end is fixedly connected to the outer wall of the proximal main handle (1); A surface of the limiting handle member (32) on one side facing the positioning handle member (21) is provided with a plurality of sawtooth grooves (320) radially spaced apart from each other along the proximal main handle (1); a surface of the positioning handle member (21) on one side facing the limiting handle member (32) is provided with at least one sawtooth protrusion (210); when the second spring (31) is in a free state, the sawtooth protrusion (210) is engaged with any of the sawtooth grooves (320).

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