Covered stent in-situ windowing and membrane rupture device and puncture and membrane expansion two-in-one guide wire

Abstract

The invention provides a covered stent in-situ windowing and membrane rupture device and a puncture and membrane expansion two-in-one guide wire, and relates to the field of medical instruments, and the device comprises the puncture and membrane expansion two-in-one guide wire and a quick release handle; the puncture and membrane expansion two-in-one guide wire comprises an inner guide wire, a pushing tube and a membrane expansion supporting net. The inner guide wire comprises a core wire and a reducing winding spring; the core wire penetrates through the pushing pipe; the near-end main handle and the far-end main handle slide relatively in the axial direction, and the supporting net rack expands in the radial direction or contracts in the radial direction to the core wire. The guide wire can improve the positioning accuracy of the guide wire at a windowing membrane rupture point of the covered stent and quickly rupture a membrane, can synchronously broach a puncture hole, and meanwhile, can achieve the effect that the guide wire is put in one time and alternately put in a plurality of instruments, thereby achieving the effects of simplifying the operation steps, improving the operation efficiency and reducing the injury to a patient in the operation process.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an in-situ window-opening and membrane-breaking device for a coated stent and a two-in-one guide wire for puncturing and dilating the membrane. Background Art

[0002] Aortic disease is a common disease in the spectrum of cardiovascular diseases, and the incidence rate is growing rapidly. For example, aortic aneurysm, atherosclerosis, arterial dissection, aortic ulcer, etc. These diseases greatly endanger human health and even endanger life. For aortic aneurysm, reconstruction of blood vessels by inserting covered stents in blood vessels has the advantages of low risk, less trauma, fast recovery, and simplified surgical procedures. The covered stent is implanted into the aneurysm by incision or puncture of the femoral artery, and the normal arteries at the proximal and distal ends of the aneurysm are connected through the covered stent. Arterial blood flow no longer fills the aneurysm body, and the aortic aneurysm body will slowly thrombose, thereby isolating the aortic aneurysm.

[0003] Since the aorta has many important branch vessels, such as the subclavian artery, celiac trunk, renal artery, mesenteric artery, etc., these branch vessels provide blood supply to important organs of the body. Therefore, when some aortic aneurysms involve these important branch vessels, directly isolating the aortic aneurysm with a covered stent will also cover these important branch vessels, resulting in insufficient blood supply to important organs. For this, it is necessary to use aortic aneurysm stent fenestration technology (pre-fenestration and in situ fenestration), that is, to accurately locate on the covered stent, calculate the position of the important branch vessels, remove the film on this part of the covered stent, and ensure that the blood supply of the important branch vessels can be ensured through the fenestration on the covered stent after implantation. However, due to the differences in the lesion location, vessel size, and branch location of aortic aneurysm patients, in situ fenestration is preferred over pre-fenestration and in situ fenestration.

[0004] In the prior art, in situ fenestration generally uses imaging equipment to image the lesion site. Under the guidance of the imaging equipment, medical staff locate the opening of the branch blood vessels, insert the sheath from the femoral artery or brachial artery to the aorta, and send the guiding catheter with different head angles along the sheath, so that the guiding catheter head is aligned with the branch opening angle, and send the guide wire along the guiding catheter to pierce the membrane of the stent graft where the fenestration is required. Then the guiding catheter is withdrawn, and the balloon catheter for membrane expansion is inserted along the guide wire for expansion treatment, so as to complete the in situ fenestration. In situ fenestration of the aortic stent graft has high requirements for interventional instruments. It needs to cooperate with instruments such as adjustable curved sheaths, adjustable curved catheters, and puncture needle membrane rupture devices. The use of in situ fenestration needles, lasers and other membrane rupture instruments has high requirements for the operator's intraoperative operation and judgment capabilities.

[0005] The existing in situ fenestration has at least the following problems: (1) The guidewires used in the prior art are universal guidewires, which often have problems such as difficulty in piercing the coating at the tip end after positioning, or inaccurate positioning due to lack of effective support or weak support points in the guide sheath. These problems require replacement of the guidewire and repeated debugging, which not only complicates the operation, but also prolongs the surgical operation time and increases the surgical risk. (2) After the in situ window puncture and membrane rupture is successful, how to bring in the membrane expansion balloon to complete the membrane expansion is also a major problem in the existing technology. The difficulty mainly lies in: the membrane rupture point opening is much smaller than the balloon catheter tip. Therefore, after the membrane ruptures, the balloon catheter tip is easily stuck and cannot pass after contacting the membrane during the process of the balloon entering along the guide wire. To solve this problem, doctors currently deal with it by cutting, squeezing, etc. to shape the balloon catheter tip and then insert it. However, such an operation damages the balloon catheter tip, which will affect the smoothness of the balloon catheter inside the blood vessel. It may also cause damage to the blood vessel when the balloon catheter is inserted and removed, or bring in foreign objects when it is inserted, causing thrombosis. In addition, the on-site shaping of the balloon catheter tip also increases the operation time and increases the risk of surgery; (3) In the prior art, since the guide wire is too thin and soft, it is difficult to assemble it with the existing operating handle in a detachable manner. Therefore, there are mainly two ways to push and pull the puncture guide wire: ① The operator directly holds the proximal (rear) end of the guidewire and pushes and pulls the guidewire. This method is inconvenient for the operator to operate the thin guidewire, and it is impossible to lock the guidewire with other instruments (such as balloon catheters) inserted along the guidewire, which is prone to inaccurate positioning; ② The guidewire handle is fixedly connected to the proximal (rear) end of the guidewire. When inserting the instrument in this way, due to the obstruction of the guidewire handle, the guidewire cannot be inserted first and then the instrument. The instrument can only be put on the guidewire from the distal end to the proximal end of the guidewire, and then the guidewire is inserted while the instrument is inserted. Before the instrument inserted along the guidewire needs to be withdrawn, the guidewire needs to be withdrawn from the patient's body first, and then the instrument is withdrawn. When other instruments need to be replaced, the replaced instrument needs to be put on the guidewire from the distal end to the proximal end of the guidewire after the guidewire is withdrawn, and then the new instrument is inserted while the guidewire is inserted. The operation is also complicated. Summary of the invention

[0006] The purpose of the present invention is to provide an in situ fenestration and membrane rupture device for a coated stent and a two-in-one guide wire for puncture and membrane expansion to alleviate the above-mentioned technical problems.

[0007] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions: In a first aspect, an embodiment of the present invention provides an in situ fenestration and membrane rupture device for a covered stent, comprising a two-in-one guide wire for puncture and membrane expansion and a quick-release handle; The two-in-one puncture and membrane expansion guide wire comprises an inner guide wire, a push tube and a membrane expansion support net; The inner guide wire comprises a core wire and a variable diameter coil spring; the core wire passes through the push tube, the variable diameter coil spring is wrapped around the outside of the distal end section of the core wire, and the distal end of the variable diameter coil spring is fixedly connected to the distal end of the core wire; the variable diameter coil spring comprises a proximal large diameter coil spring tube section, a middle variable diameter coil spring tube section and a distal small diameter coil spring tube section which are sequentially connected along the axial direction of the core wire; the membrane expansion support net comprises a support grid frame, the support grid frame is sleeved outside the part of the core wire located on the proximal side of the variable diameter coil spring, and can slide axially relative to the core wire; the proximal end of the support grid frame is fixedly connected to the distal end of the push tube, and the distal end of the support grid frame is fixedly connected to the proximal end of the proximal large diameter coil spring tube section; The quick-release handle includes a proximal handle assembly, a distal handle assembly and a locking assembly; The distal handle assembly comprises a distal main handle having an axial through hole; the proximal end of the push tube is connected to the distal main handle in a detachable manner; The proximal handle assembly comprises a proximal main handle having an axial through hole and a positioning mechanism installed on the proximal main handle; the proximal main handle is arranged 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 pushing tube, and the positioning mechanism can position or release the core wire on the proximal main handle; 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; Axially sliding the proximal main handle and the distal main handle relative to each other can cause the support grid to radially expand or radially contract relative to the core wire.

[0008] The use and effects of the in-situ fenestration and membrane rupture system for the aortic stent graft provided in this embodiment are as follows: Before use, the push tube is sleeved on the outside of the core wire, and the proximal end of the push tube is connected to the distal main handle; the core wire is passed through the axial through hole of the distal main handle and the axial through hole of the proximal main handle in the proximal direction, and the core wire is positioned on the proximal main handle by using the positioning mechanism; the proximal main handle and the distal main handle are axially relatively slid to make the support grid radially contract to the core wire, and then the proximal main handle is locked to the distal main handle by using the locking assembly; Then, under percutaneous puncture, a guide wire is inserted into the branch blood vessel of the aorta to be fenestrated in situ to the lesion site, a guide sheath is inserted along the guide wire, and then the guide wire is withdrawn, and the push tube of this embodiment is inserted into the guide sheath, and the guide sheath is adjusted so that the distal end of the core wire of this embodiment is nearly perpendicular to the coating of the aortic stent graft to be fenestrated in situ; 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. Then, in the first step, the core wire is pushed into the distal end by holding the quick-release handle, so that the distal end of the core wire pierces the membrane of the aortic stent graft until the support mesh enters or passes through the puncture hole pierced by the distal end of the core wire in the membrane; In this process, since the distal end of the core wire is wrapped with a variable diameter coil spring, the distal structural strength of the core wire is enhanced, and the membrane can be easily and quickly broken. The variable diameter coil spring has a certain amount of elasticity between the coils, so that the distal structure of the core wire is not too hard (still has a certain degree of flexibility) to meet the delivery requirements of the core wire inside the blood vessel; in addition, since the variable diameter coil spring includes a proximal large diameter coil spring tube section, a middle variable diameter coil spring tube section and a distal small diameter coil spring tube section; The distal end of the small-diameter spring tube section is fixedly connected to the distal end of the core wire, and the support grid is sleeved outside the portion of the core wire located on the proximal side of the variable-diameter spring, so that a conical diameter reduction slope is formed at the junction of the middle variable-diameter spring tube section and the distal small-diameter spring tube section, and the conical diameter reduction slope can quickly guide the proximal large-diameter spring tube section and the support grid through the puncture hole after the distal end of the core wire punctures a puncture hole on the coating to preliminarily expand the puncture hole; The second step is to axially slide the proximal main handle and the distal main handle relative to each other to radially expand the support grid, and the puncture hole can be further enlarged by the expanded support grid; After the above operations are completed, the locking assembly is used to unlock the proximal main handle to the distal main handle, the positioning of the core wire by the positioning mechanism is released, the proximal main handle and the distal main handle are detached from the core wire and the proximal end of the push tube, the quick-release handle is removed, and the core wire and the push tube are axially slid relative to each other to cause the support grid to shrink radially. In this process, since the core wire is positioned to the proximal main handle by the positioning mechanism, the proximal end of the push tube is connected to the distal main handle in a detachable manner, and a locking assembly is provided between the proximal main handle and the distal main handle, thereby, the proximal main handle and the distal main handle can be detached from the core wire and the push tube respectively without interfering with each other; then, the branch coated stent or other subsequent instruments used for treatment can be further inserted through the membrane puncturing two-in-one guide wire, thereby simplifying the surgical steps and improving the surgical efficiency.

[0009] In summary, the in situ fenestration and membrane rupture system for the coated stent provided in the embodiment of the present invention can improve the positioning accuracy of the guide wire at the fenestration and membrane rupture point of the coated stent and quickly rupture the membrane during the in situ fenestration surgery of the coated stent, and can simultaneously expand the puncture hole. At the same time, it can realize the alternating insertion of multiple instruments with a single guide wire (core wire), thereby simplifying the surgical steps, improving the surgical efficiency, and reducing the damage to the patient during the operation.

[0010] For more specific structural details of the in situ fenestration and membrane rupture device of the coated stent, please refer to the detailed description in the specific implementation method section of this specification.

[0011] In a second aspect, an embodiment of the present invention provides a two-in-one guidewire for puncture and membrane dilation, which is applied to the in situ fenestration and membrane rupture device of the coated stent described in any of the aforementioned embodiments.

[0012] The two-in-one puncture and membrane expansion guide wire comprises an inner guide wire, a push tube and a membrane expansion support net; The inner guide wire comprises a core wire and a variable diameter coil spring; the core wire passes through the push tube, the variable diameter coil spring is wrapped around the outside of the distal end section of the core wire, and the distal end of the variable diameter coil spring is fixedly connected to the distal end of the core wire; the variable diameter coil spring comprises a proximal large diameter coil spring tube section, a middle variable diameter coil spring tube section and a distal small diameter coil spring tube section which are sequentially connected along the axial direction of the core wire; The membrane expansion support net includes a support grid, which is sleeved on the outside of the core wire at the proximal side of the variable diameter coil spring and can slide axially relative to the core wire; the proximal end of the support grid is fixedly connected to the distal end of the push tube, and the distal end of the support grid is fixedly connected to the proximal end of the proximal large diameter coil spring tube section.

[0013] The effect that can be achieved by the two-in-one puncture and membrane dilation guidewire provided in the embodiment of the present invention can be referred to the in-situ fenestration and membrane rupture device for the coated stent provided in the first aspect.

[0014] In particular, in the embodiments of the present invention, “and / or” indicates that the first feature before “and / or” and the second feature after “and / or” include the following specific configurations: (1) only the first feature is set without the second feature; (2) only the second feature is set without the first feature; (3) the first feature and the second feature are set at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0016] Figure 1 A schematic diagram of the overall structure of an in situ fenestration and membrane rupture device for a covered stent provided in an embodiment of the present invention, wherein the two-in-one guide wire for puncture and membrane expansion is a first optional structure; Figure 2 for Figure 1 A magnified view of the local structure of area A in the middle; Figure 3 for Figure 1 A magnified view of the local structure of the middle B area; Figure 4 A schematic diagram of the distal region of the second optional structure of the two-in-one guide wire for puncturing and dilating the membrane in the in situ fenestration and membrane rupture device for the covered stent provided in an embodiment of the present invention; Figure 5 A schematic diagram of the overall structure of a quick-release handle in the in-situ fenestration and membrane rupture device for a coated stent provided in an embodiment of the present invention.

[0017] 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 piece; 210-serrated protrusion; 211-pressing block; 2111-first limiting column; 212-pressing rod; 2121-extension; 22-first spring; 23-hose; 3-limiting assembly; 31-second spring; 32-limiting handle piece; 320- Sawtooth groove; 321-second limiting column; 120-distal handle assembly; 121-distal main handle; 1211-second Luer connector; 1212-first limiting flange; 1213-second limiting flange; 1214-first magnetic member; 1215-second magnetic member; 130-locking assembly; 131-middle sleeve; 1310-threaded groove; 132-push-pull handle member; 133-elastic pressure strip; 1331-pressing protrusion; 1332-limiting protrusion; 41-core wire; 42-reducing spring; 421-proximal large-diameter spring tube section; 422-middle reducing spring tube section; 423-distal small-diameter spring tube section; 5-push tube; 501-first Luer connector; 51-push main tube; 52-spring tube; 6-membrane expansion support net; 61-support grid; 62-inner support assembly; 621-connecting block; 622-limiting block; 623-connecting wire; 7-guide head; 8-developing ring; 9-sleeve connector. DETAILED DESCRIPTION

[0018] In order to make the purpose, 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 in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0019] 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 invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0020] It should be noted that like reference numerals and letters denote similar items in the drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0021] In the description of the present invention, it should be noted that: Unless otherwise clearly specified and limited, the terms "disposed", "installed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0022] The orientation or position relationship indicated by the terms "proximal", "distal", "front end", "rear end", "axial", "radial", "inner", "outer", etc. is based on the orientation or position relationship shown in the drawings, or is the orientation or position relationship in which the product of the invention is usually placed when used. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0023] The terms “first”, “second”, etc. are only used for distinguishing descriptions and do not indicate the total number or relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0024] Below, some embodiments of the present invention are described in detail in conjunction with the accompanying drawings, with the end of the medical device close to the operator during surgery being the proximal end of the medical device, and the end of the medical device entering the patient's blood vessel being 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).

[0025] Embodiment 1 This embodiment provides a device for in situ fenestration and membrane rupture of a covered stent, referring to Figures 1 to 5 The in situ fenestration and membrane rupture device of the coated stent comprises a two-in-one guide wire for puncturing and dilating the membrane and a quick-release handle 100.

[0026] Specifically, the two-in-one guide wire for puncturing and expanding membrane includes an inner guide wire, a push tube 5, and a membrane expansion support net 6. The inner guide wire includes 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 includes 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 423 connected in sequence along the axial direction of the core wire 41; the membrane expansion support net 6 includes a support grid frame 61, which is sleeved outside the part of the core wire 41 located on the proximal side of the variable diameter coil spring 42 and can slide axially relative to the core wire 41; the proximal end of the support grid frame 61 is fixedly connected to the distal end of the push tube 5, and the distal end of the support grid frame 61 is fixedly connected to the proximal end of the proximal large diameter coil spring tube section 421.

[0027] 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 connected to the distal main handle 121 in a detachable manner. The proximal handle assembly 110 includes a proximal main handle 1 having an axial through hole and a positioning mechanism 2 installed 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 push tube 5, and the positioning mechanism 2 can position or release the core wire 41 on the proximal main handle 1. The locking assembly 130 is installed 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 .

[0028] The use and effects of the in-situ fenestration and membrane rupture system for the aortic stent graft provided in this embodiment are as follows: Before use, the push tube 5 is sleeved on the outside of 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 on the proximal main handle 1 by using the positioning mechanism 2; the proximal main handle 1 and the distal main handle 121 are axially relatively slid to make the support grid 61 radially contract 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; Then, under percutaneous puncture, a guide wire is inserted into the branch blood vessel of the aorta to be fenestrated in situ to the lesion site, a guide sheath is inserted along the guide wire, and then the guide wire is withdrawn, and the push tube 5 of this embodiment is inserted into the guide sheath, and the guide sheath is adjusted so that the distal end of the core wire 41 of this embodiment is nearly perpendicular to the coating of the aortic stent graft to be fenestrated in situ; In this process, the core wire 41 is positioned at 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. Then, in the first step, the quick-release handle 100 is held to push the core wire 41 distally, so that the distal end of the core wire 41 punctures the membrane of the aortic stent graft until the support grid 61 enters or passes through the puncture hole punctured in the membrane by the distal end of the core wire 41; In this process, since the outer portion of the distal end of the core wire 41 is wrapped with a variable diameter coil spring 42, the distal structural strength of the core wire 41 is enhanced, and the membrane rupture can be completed easily and quickly. The coils of the variable diameter coil spring 42 have a certain amount of elasticity, so that the distal structure of the core wire 41 is not too hard (still has a certain degree of flexibility) to meet the delivery requirements of the core wire 41 inside the blood vessel; in addition, since the variable diameter coil spring 42 includes a proximal large diameter coil spring tube segment 421, a middle variable diameter coil spring tube segment 422 and a distal small diameter coil spring tube segment 423; the distal end The distal end of the small-diameter spring tube segment 423 is fixedly connected to the distal end of the core wire 41, and the support grid 61 is sleeved outside the portion of the core wire 41 located on the proximal side of the variable-diameter spring 42, so that a conical diameter reduction slope is formed at the intersection of the middle variable-diameter spring tube segment 422 and the distal small-diameter spring tube segment 423, and the conical diameter reduction slope can quickly guide the proximal large-diameter spring tube segment 421 and the support grid 61 through the puncture hole after the distal end of the core wire 41 punctures a puncture hole in the coating to preliminarily expand the puncture hole; The second step is to axially slide the proximal main handle 1 and the distal main handle 121 relative to each other to radially expand the support grid 61, and the puncture hole can be further enlarged by the expanded support grid 61; After the above operations are completed, the locking assembly 130 is used to unlock the proximal main handle 1 to the distal main handle 121, the positioning of the core wire 41 by the positioning mechanism 2 is released, the proximal main handle 1 and the distal main handle 121 are detached from the proximal end of the core wire 41 and the pushing tube 5, the quick-release handle 100 is removed, and the core wire 41 and the pushing tube 5 are axially slid relative to each other to make the supporting grid 61 contract radially. In this process, since the core wire 41 is positioned to the proximal main handle 1 by the positioning mechanism 2, the proximal end of the pushing tube 5 is connected to the distal main handle 121 in a detachable manner, and a locking assembly 130 is provided between the proximal main handle 1 and the distal main handle 121, so that the proximal main handle 1 and the distal main handle 121 can be detached from the core wire 41 and the pushing tube 5 respectively without interfering with each other; then, the branch coated stent or other subsequent instruments used for treatment can be further inserted through the puncture and membrane rupture two-in-one guide wire, thereby simplifying the surgical steps and improving the surgical efficiency.

[0029] In summary, the stent graft in situ fenestration and membrane rupture system provided in the present embodiment can improve the positioning accuracy of the guide wire at the stent graft fenestration and membrane rupture point and quickly rupture the membrane during the stent graft in situ fenestration surgery, and can simultaneously expand the puncture hole. At the same time, a single guide wire (core wire 41) can be inserted alternately into multiple instruments, thereby simplifying the surgical steps, improving the surgical efficiency, and reducing the damage to the patient during the operation.

[0030] There are many optional implementations for the specific structure of the membrane expansion support network 6 in this embodiment. For example, in one optional implementation, Figure 3 As shown, the expansion film support network 6 includes a support grid 61 and at least one group (preferably but not limited to) arranged inside the support grid 61. Figure 3 The two groups of internal support components 62 shown in the figure are shown in the figure. The support grid 61 is sleeved on the outside of the part of the core wire 41 located on the proximal side of the variable diameter coil spring 42, and can slide axially 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. Each group of internal support components 62 respectively includes 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 the part of the core wire 41 located on the proximal side of the variable diameter coil spring 42, and can slide axially relative to the core wire 41; a plurality of connecting wires 623 are circumferentially spaced around the core wire 41, and one end of each connecting wire 623 is fixedly connected to the connecting block 621, and the other end is fixedly connected to the support 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.

[0031] like Figure 3As shown, in this optional embodiment, when the core wire 41 is withdrawn in the proximal direction relative to the push tube 5, the distal end of the push tube 5 (the proximal end of the support grid 61) remains stationary, and the core wire 41 slides with the distal end of the support grid 61 toward the proximal direction, so that the connecting block 621 slides along the core wire 41 in the distal direction. During the sliding process, the multiple connecting wires 623 connected to the connecting block 621 are radially expanded along the core wire 41, which will radially open the support grid 61 along the core wire 41. In addition, during the process, due to the provision of the limit block 622, it is possible to prevent the connecting block 621 from excessively sliding to the axial opposite side so that the support grid 61 changes from a radially expanded state to a radially contracted state; the operator can control the degree of withdrawal of the core wire 41 in the proximal direction relative to the push tube 5 according to the degree of expansion of the puncture hole as needed, so as to control the radial expansion degree of the support grid 61, and then control the diameter range of the expansion of the puncture hole. After the hole expansion is completed, the core wire 41 is pushed in the distal direction relative to the push tube 5, so that the support grid 61 can be restored to the state of radial contraction to the core wire 41. In this embodiment, the connection block 621 is preferably connected with the core wire 41 by friction fit to further increase the positioning ability between the two, but it should be understood by those skilled in the art that after the core wire 41 and the push tube 5 are axially relatively positioned, the position of the support grid 61 relative to the two ends of the core wire 41 is fixed, so that the support grid 61 can maintain a radial expansion state. Therefore, the aforementioned connection block 621 is preferably connected with the core wire 41 by friction fit, which is not a necessary setting condition for the assembly relationship between the connection block 621 and the core wire 41, but is only a more preferred condition for increasing the stability of the support grid 61 in the expansion state for this optional embodiment.

[0032] For example, in another optional embodiment, Figure 4 As shown, the membrane expansion support mesh 6 is a separate mesh structure, but this structure requires selecting a mesh of appropriate density according to the diameter range of the puncture hole 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.

[0033] In addition, in order to maximize the smoothness of the guide wire when entering and exiting the puncture hole formed after the membrane of the aortic covered stent is punctured during use, in the optional implementation of the present embodiment, no matter which of the above-mentioned specific optional structures of the membrane expansion support net 6 is used, the membrane expansion support net 6 is in a radially expanded state and is in a spindle shape with a cylindrical middle part in the axial direction and tapered ends, so as to facilitate the membrane expansion support net 6 to quickly enter and exit the puncture hole on the membrane in the radially expanded state, thereby further improving the efficiency of the operation.

[0034] In addition, in an optional implementation of the present embodiment, the push tube 5 includes a push tube 51 and a spring tube 52; the spring tube 52 is sleeved on the distal end section of the push tube 51, and the proximal and distal ends of the spring tube 52 are fixedly connected to the outer wall of the push tube 51. More specifically, a sleeve joint 9 sleeved on the outside of the core wire 41 and with a diameter gradually increasing from the proximal end to the distal end is fixed at the distal end of the push tube 51, and the proximal end of the spring tube 52 is fixedly connected to the distal end of the sleeve joint 9; the proximal end of the membrane expansion support net 6 is fixedly connected to the spring tube 52. The structure of this optional implementation can increase the structural strength of the push tube 5 through the spring tube 52, further improve the stability of the membrane expansion support net 6 when it is in a radial expansion state, and the outer peripheral surface of the sleeve joint 9 can be used as a conical guide surface to increase the smoothness of the spring tube 52 entering and exiting the puncture hole on the membrane.

[0035] In some optional implementations of the present embodiment, the portion of the core wire 41 located inside the variable diameter coil spring 42 is in a shape that changes in diameter synchronously with the variable diameter coil spring 42 .

[0036] In some optional implementations of the present embodiment, the inner guide wire also includes a guide head 7, the distal ends of the variable diameter spring 42 and the core wire 41 are both connected to the guide head 7, and the distal end face of the guide head 7 is hemispherical or conical with the tip facing the distal end; by providing the guide head 7, it is possible to prevent the connection between the distal end of the distal small diameter spring tube section 423 and the distal end of the core wire 41 from piercing the inner wall of the blood vessel during the transmission of the guide wire in the blood vessel.

[0037] In some optional implementations of the present embodiment, at least one of the five axial ends of the support frame 61, the outer wall of the proximal large-diameter spring tube segment 421, the proximal end of the distal small-diameter spring tube segment 423, and the distal end of the distal small-diameter spring tube segment 423 is fixedly connected with a developing ring 8 to indicate each point under X-ray development to help the surgeon perform accurate surgery.

[0038] In the present embodiment, there are a variety of specific detachable connection modes 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 together, wherein, optionally, the proximal end of the push tube 5 is provided with a first Luer connector 501, and the distal surface of the distal main handle 121 is provided with a second Luer connector 1211, and the first Luer connector 501 is screwed with the second Luer connector 1211.

[0039] In this embodiment, the locking assembly 130 also has a variety of optional implementations, such as but not limited to providing a snap-fit ​​structure at the distal end of the proximal main handle 1 and / or the proximal end of the distal main handle 121, and the two are mutually snapped when docked, but this structure is not easy to operate when unlocked, and the amplitude is large, which may cause damage to the patient. In order to increase the convenience and flexibility of operation and reduce the amplitude of movement when unlocking to reduce damage to the patient, in some optional implementations of this embodiment, the locking assembly 130 includes a middle sleeve 131, a push-pull handle member 132 and an elastic pressure strip 133; a side wall through hole connecting 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 pressure strip 133 is provided on the distal main handle 121; The elastic 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 strip 133 is fixedly connected to the inner wall of the axial through hole of the distal main handle 121; the side surface of the elastic strip 133 facing the outside of the side wall through hole of the distal main handle 121 is provided with a pressing protrusion 1331, 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; the proximal end of the elastic strip 133 is provided with a limiting protrusion 1332 protruding radially inward along the distal main handle 121; 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, and 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 circumference 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 the middle sleeve 131 is axially limited to the proximal main handle 1" includes but is not limited to providing an extended pipe section at the distal end of the proximal main handle 1, providing an annular protrusion extending along the circumference of the extended pipe section on the outer circumference of the extended pipe section, and providing an annular groove extending along the circumference of the middle sleeve on the inner circumference of the middle sleeve 131, so that the aforementioned annular protrusion is limited in the annular groove. For ease of assembly, the middle sleeve can be provided as a structure including two half shells cut along the axial direction, and the two half shells are then clamped to each other. The push-pull handle 132 has a locking position and an unlocking position. When the distal main handle 121 is in the locking position, it is sleeved on the outside of 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 separated from the thread 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 locked, which is more convenient to operate.

[0040] In order to maintain the stability of the push-pull handle member 132 in the locking position and the unlocking position respectively, in this optional 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 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 surface of the second limiting flange 1213; the push-pull handle member 132 is made of a material that can attract the first magnetic member 1214 and the second magnetic member 1215 respectively, or a third magnetic member that can attract the first magnetic member 1214 and the second magnetic member 1215 is provided on the push-pull handle member 132.

[0041] In addition, in the present embodiment, in the proximal handle assembly 110, the positioning mechanism 2 also has a variety of optional structural types, but it is necessary to be able to position or release the proximal segment of the thinner core wire 41 in the inner wall of the axial through hole of the proximal main handle 1, for example, continue to refer to Figure 5 In some optional implementations of the present embodiment, the positioning mechanism 2 of the proximal handle assembly 110 includes a positioning handle member 21, a first spring 22, a hose 23 and a limit assembly 3. The proximal main handle 1 is also provided with a side wall through hole connecting the outer wall of the proximal main handle 1 and the axial through hole; the hose 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 hose 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 position and a second position. When the positioning handle member 21 is in the first position, the first spring 22 is compressed and the end of the pressing rod 212 away from the pressing block 211 is radially inwardly squeezed on the hose 23 along the proximal main handle 1. 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 away from the pressing block 211 releases the hose 23; the limiting component 3 is movably installed on the outside of the proximal main handle 1, and the limiting component 3 can lock or release the positioning handle member 21 to the proximal main handle 1.

[0042] Among them, there are many optional structures of the limit component 3, for example but not limited to, the limit component 3 is as follows: 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.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] Embodiment 2 The present embodiment provides a two-in-one guide wire for puncture and membrane expansion, which is applied to the in-situ fenestration and membrane rupture device for the coated stent provided in any optional implementation manner in the first embodiment.

[0048] The two-in-one guide wire for puncturing and expanding membrane includes an inner guide wire, a push tube 5 and a membrane expansion support net 6. The inner guide wire includes 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 includes 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 423 which are sequentially connected along the axial direction of the core wire 41; the membrane expansion support net 6 includes a support grid frame 61, which is sleeved outside the part of the core wire 41 located on the proximal side of the variable diameter coil spring 42 and can slide axially relative to the core wire 41; the proximal end of the support grid frame 61 is fixedly connected to the distal end of the push tube 5, and the distal end of the support grid frame 61 is fixedly connected to the proximal end of the proximal large diameter coil spring tube section 421.

[0049] Finally, it should be noted that the above embodiments and their optional implementation modes 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 aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned optional implementation modes, or replace some or all of the technical features therein by equivalents. 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 the features of the embodiments in this specification and the optional implementation modes in the embodiments can be combined with each other without conflict.

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 ends of the variable diameter coil spring (42) and the core wire (41) are both connected to the guide head (7), and the distal end surface of the guide head (7) is hemispherical or conical 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).

10. A two-in-one puncture and membrane expansion guide wire, characterized in that: The in situ fenestration and membrane rupture device for the stent graft as claimed in any one of claims 1 to 9; 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 (423) which are sequentially connected along the axial direction of the core wire (41); The membrane expansion support net (6) comprises a support grid frame (61), which is sleeved on the outside of the core wire (41) located on the proximal side of the variable diameter coil spring (42) and can slide axially relative to the core wire (41); the proximal end of the support grid frame (61) is fixedly connected to the distal end of the push tube (5), and the distal end of the support grid frame (61) is fixedly connected to the proximal end of the proximal large diameter coil spring tube section (421).

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