Aortic stent graft in situ fenestration system

Abstract

The present invention provides an in-situ window rupture system for an aortic stent graft, comprising a guidewire, a balloon catheter and a quickly detachable handle; the guidewire comprises a core wire, a spring wire and a stopper; the stopper is arranged on the proximal side of the spring wire and the proximal end is fixed to the core wire or connected to the middle section of the spring wire; the balloon catheter is sleeved on the outside of the core wire; the distal end face of the balloon catheter is blocked on the proximal side of the middle diameter expansion section of the stopper; the quickly detachable handle comprises a handle assembly 1, a handle assembly 2 and a locking assembly; the first main handle and the second main handle are axially relatively slidable, so that the distal end face of the balloon catheter can abut against or be away from the middle diameter expansion section of the stopper. The present invention can improve the positioning accuracy of the guidewire at the window rupture point of the stent graft and quickly rupture the membrane, and can also synchronously expand the puncture hole, and at the same time, can realize the alternate insertion of multiple instruments by a single guidewire insertion, so as to simplify the surgical steps, improve the surgical efficiency, and reduce the damage to the patient during the surgical process.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an in-situ fenestration and membrane rupture system for an aortic stent graft. 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 that 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 example, when the lesion occurs in the thoracic aorta, the upper part of the human aorta is an arched aortic arch. The part of the aorta adjacent to the aortic arch is the ascending aorta, and the other part of the aorta is the descending aorta. The convex side of the aortic arch is the greater curvature, and the concave side of the aorta is the lesser curvature. There are three important branch vessels on the greater curvature: the innominate artery (i.e., the brachiocephalic artery), the left common carotid artery, and the left subclavian artery. When lesions occur in the aortic arch, such as dissection or aneurysm, a covered stent needs to be implanted in the aortic arch for treatment, but the covered stent should not block the above three important branch vessels. For this purpose, it is necessary to adopt aortic aneurysm stent fenestration technology (pre-fenestration and in situ fenestration), that is, to accurately locate on the stent graft, calculate the position of important branch blood vessels, remove the coating on this part of the stent graft, and ensure that after the stent graft is implanted, the blood supply to important branch blood vessels can be ensured through the fenestration on the stent graft.

[0004] Since there are differences in the location of lesions, blood vessel size, and branch locations among patients with aortic aneurysms, in situ fenestration is preferred over pre-fenestration and in situ fenestration. Imaging equipment is used to perform contrast imaging of the lesion site. Under the guidance of the imaging equipment, medical staff locate the opening of the branch vessels, insert the sheath from the femoral artery or brachial artery into the aorta, and insert the guide catheter with different head angles along the sheath. The guide catheter head is aligned with the branch opening angle, and the guide wire is inserted along the guide catheter to pierce the membrane of the stent graft where the window is required. The guide catheter is then withdrawn, and the balloon catheter for membrane expansion is inserted along the guide wire for expansion treatment to complete the in situ fenestration. In situ fenestration of the aortic stent graft has high requirements for interventional devices. It needs to be coordinated with devices 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 devices places high demands on the operator's intraoperative operation and judgment capabilities.

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

[0006] (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.

[0007] (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;

[0008] (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:

[0009] 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;

[0010] 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

[0011] The object of the present invention is to provide an in situ fenestration and membrane rupture system for an aortic stent graft to alleviate the above-mentioned technical problems.

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

[0013] An embodiment of the present invention provides an in-situ fenestration and membrane rupture system for an aortic stent graft, comprising a guide wire, a balloon catheter, and a quickly detachable handle;

[0014] The guide wire comprises a core wire, a spring wire and a limiter;

[0015] The spring wire is spirally wrapped around the distal end of the core wire and is tubular, including a proximal spring wire tube section and a distal spring wire tube section; the distal spring wire tube section includes a proximal large-diameter spring wire tube section, a middle reduced-diameter spring wire tube section and a distal small-diameter spring wire tube section that are sequentially connected along the axial direction of the core wire; the distal end of the distal small-diameter spring wire tube section is fixedly connected to the distal end of the core wire;

[0016] The limiting member is sleeved on the outside of the distal end section of the core wire, wherein the limiting member is arranged on the proximal side of the proximal spring wire tube section and the proximal end of the limiting member is fixedly connected to the core wire; or, the limiting member is arranged between the proximal spring wire tube section and the distal spring wire tube section, the proximal end of the limiting member is fixed or integrally connected to the distal end of the proximal spring wire tube section, the distal end of the limiting member is fixed or integrally connected to the proximal end of the distal spring wire tube section, and the proximal end of the proximal spring wire tube section is fixedly connected to the core wire;

[0017] The limiting member comprises a proximal small diameter section, a middle expanded diameter section and a distal small diameter section which are sequentially connected along the axial direction of the core wire;

[0018] The balloon catheter is sleeved outside the core wire, and the proximal end of the balloon catheter is provided with a filling interface connected with the balloon; the distal end face of the balloon catheter is blocked at the proximal side of the middle diameter expansion section of the stopper;

[0019] The quickly detachable handle comprises a handle assembly 1, a handle assembly 2 and a locking assembly;

[0020] The handle assembly 2 comprises a second main handle having an axial through hole; the proximal end of the balloon catheter is connected to the second main handle in a detachable manner;

[0021] The handle assembly 1 comprises a first main handle having an axial through hole and a positioning assembly installed on the first main handle; the first main handle is arranged on the proximal side of the second main handle, the core wire passes through the axial through hole of the first main handle, the axial through hole of the second main handle and the balloon catheter, and the positioning assembly can position or release the core wire on the first main handle;

[0022] The locking assembly is mounted on the first main handle and / or the second main handle, and is used to lock or unlock the first main handle to the second main handle;

[0023] Axially sliding the first main handle and the second main handle relative to each other can make the distal end surface of the balloon catheter abut against or move away from the middle expanded diameter section of the limiting member.

[0024] The use and effects of the in-situ fenestration and membrane rupture system for the aortic stent graft provided by the embodiment of the present invention are as follows:

[0025] Before use, the balloon catheter is sleeved on the outside of the core wire, and the proximal end of the balloon catheter is connected to the second main handle; the core wire is passed through the axial through hole of the second main handle and the axial through hole of the first main handle in the proximal direction, and the core wire is positioned on the first main handle by using the positioning assembly; the first main handle and the second main handle are axially relatively slid to make the distal end face of the balloon catheter abut against the middle expanded diameter section of the limiter, and then the first main handle is locked to the second main handle by using the locking assembly; the balloon catheter is kept in an unfilled state;

[0026] 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 balloon catheter of the embodiment of the present invention is inserted into the guide sheath, and the guide sheath is adjusted so that the distal end of the core wire of the embodiment of the present invention is nearly perpendicular to the coating of the aortic stent graft to be fenestrated in situ;

[0027] In this process, the core wire is positioned at the first main handle by the positioning component, and the first main handle and the second main handle are locked together by the locking component. The core wire can be operated by holding the first main handle and / or the second main handle of the quickly detachable handle, which is easier for the operator to hold and more convenient to operate. In addition, since a balloon catheter is also sheathed outside the core wire, even if the balloon is not inflated, it is equivalent to increasing the diameter of the core wire, thereby increasing the supporting force of the core wire in the guide sheath and improving the positioning accuracy of the core wire.

[0028] Then, in the first step, the core wire is pushed into the distal end by holding the quickly detachable handle, so that the distal end of the core wire punctures the membrane of the aortic stent graft until the stopper enters or passes through the puncture hole punctured by the distal end of the core wire in the membrane;

[0029] In this process, since the outer portion of the distal end of the core wire is spirally wrapped with a spring wire, the structural strength of the distal end of the core wire is enhanced, and the membrane can be easily and quickly broken, and there is a certain amount of elasticity between the spring wire coils, so that the distal end 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 distal spring wire tube section spirally wrapped around the distal end of the core wire includes a proximal large-diameter spring wire tube section, a middle variable-diameter spring wire tube section and a distal The distal end of the distal small-diameter spring wire tube section is fixedly connected to the distal end of the core wire, and the stopper is arranged on the proximal side of the proximal large-diameter spring wire tube section, so that the spring wire forms a tapered diameter-reducing inclined surface with a diameter gradually decreasing from the proximal end to the distal end at the intersection of the middle diameter-reducing spring wire tube section and the distal small-diameter spring wire tube section. After the distal end of the core wire punctures a puncture hole on the coating, the tapered diameter-reducing inclined surface can quickly guide the proximal large-diameter spring wire tube section and the stopper through the puncture hole to preliminarily expand the puncture hole;

[0030] The second step is to fill the balloon. Since the distal end surface of the balloon catheter abuts against the middle diameter expansion section of the stopper, the puncture hole can be further enlarged by the balloon.

[0031] After the above operations are completed, the balloon is depressurized, and then the first main handle is unlocked from the second main handle by using the locking assembly, the positioning of the core wire by the positioning assembly is released, and the first main handle and the second main handle are separated from the core wire and the proximal end of the balloon catheter. After that, the balloon catheter is withdrawn from the core wire, and the branch stent graft or other subsequent devices for treatment can be further inserted through the core wire;

[0032] During this process, since the core wire is positioned at the first main handle by the positioning assembly, the proximal end of the balloon catheter is connected to the second main handle in a detachable manner, and a locking assembly is provided between the first main handle and the second main handle. Thus, the first main handle and the second main handle can be detached from the core wire and the balloon catheter respectively without interfering with each other. When it is necessary to remove the balloon catheter and insert other subsequent instruments along the core wire, there is no need to repeatedly remove and insert the core wire, thereby simplifying the surgical steps and improving surgical efficiency.

[0033] In summary, the in situ fenestration and membrane rupture system for the aortic stent graft provided by the embodiment of the present invention can improve the positioning accuracy of the guide wire at the fenestration and membrane rupture point of the stent graft and quickly rupture the membrane during the in situ fenestration surgery of the stent graft, 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.

[0034] For more specific structural details of the aortic stent graft in situ fenestration and membrane rupture system, please refer to the detailed description in the specific implementation method section of this specification.

[0035] 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 setting methods: (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 at the same time. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] 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.

[0037] Figure 1 A schematic diagram of the overall structure of an in situ fenestration and membrane rupture system for an aortic stent graft provided by an embodiment of the present invention, wherein the guide wire is a first optional structure;

[0038] Figure 2 for Figure 1 A magnified view of the local structure of area A in the middle;

[0039] Figure 3 for Figure 1 A magnified view of the local structure of the middle B area;

[0040] Figure 4 A schematic diagram of the distal end region of the second optional structure of the guidewire in the in situ fenestration and membrane rupture system of the aortic stent graft provided by an embodiment of the present invention;

[0041] Figure 5 A schematic diagram of the distal region of the third optional structure of the guidewire in the in situ fenestration and membrane rupture system of the aortic stent graft provided by an embodiment of the present invention;

[0042] Figure 6 A schematic diagram of the overall structure of a quickly detachable handle in the in situ fenestration and membrane rupture system for the aortic stent graft provided in an embodiment of the present invention.

[0043] Icons: 100-quickly detachable handle; 110-handle assembly 1; 1-first main handle; 11-limiting flange; 111-blocking convex part; 12-end Luer connector; 2-positioning assembly; 21-positioning handle member; 210-serrated convex part; 211-pressing block; 2111-limiting column 1; 212-pressing rod; 2121-extension part; 22-spring member 1; 23-hose; 3-limiting assembly; 31-spring member 2; 32-limiting handle member; 320-serrated groove; 321-limiting column 2; 120-handle assembly 2; 121-second main handle; 1211-Luer connector 2; 1212-limiting flange 1; 1213-limiting flange 2; 1214-magnetic member 1; 1215-magnetic member 2; 130-locking assembly; 131-middle sleeve; 1310-threaded groove; 132-push-pull handle member; 133-elastic pressure strip; 1331-pressing convex portion; 1332-limiting convex portion;

[0044] 4-core wire; 5-spring wire; 51-proximal spring wire tube section; 52-distal spring wire tube section; 521-proximal large-diameter spring wire tube section; 522-middle reduced-diameter spring wire tube section; 523-distal small-diameter spring wire tube section; 53-sleeve joint; 6-limiting piece; 61-proximal tapered tube section; 62-distal tapered tube section; 7-guide head; 8-developing ring; 91-balloon catheter; 92-balloon; 93-Luer connector 1; 94-filling interface. DETAILED DESCRIPTION

[0045] 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.

[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 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.

[0047] 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.

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

[0049] 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.

[0050] 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.

[0051] 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.

[0052] 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).

[0053] This embodiment provides an in situ fenestration and membrane rupture system for an aortic stent graft, referring to Figures 1 to 3 The aortic stent graft in situ fenestration and membrane rupture system comprises a guide wire, a balloon catheter 91 and a quickly detachable handle 100 .

[0054] Specifically, Figure 3 As shown, the guide wire includes a core wire 4, a spring wire 5 and a limiter 6; the spring wire 5 is spirally wrapped around the outer portion of the distal end section of the core wire 4 and is tubular, including a proximal spring wire tube section 51 and a distal spring wire tube section 52; the distal spring wire tube section 52 includes a proximal large-diameter spring wire tube section 521, a middle reduced-diameter spring wire tube section 522 and a distal small-diameter spring wire tube section 523 which are sequentially connected along the axial direction of the core wire 4; the distal end of the distal small-diameter spring wire tube section 523 is fixedly connected to the distal end of the core wire 4.

[0055] The limiting member 6 is sleeved on the outside of the distal segment of the core wire 4, wherein the proximal spring wire tube segment 51 and the distal spring wire tube segment 52 can be connected to each other or spaced apart from each other; in some optional embodiments, the distal end of the proximal spring wire tube segment 51 and the proximal end of the distal spring wire tube segment 52 are fixed or integrally connected together, the limiting member 6 is arranged on the proximal side of the proximal spring wire tube segment 51 and the proximal end of the limiting member 6 is fixedly connected to the core wire 4, and the fixing method includes but is not limited to the following: Figures 3 to 5As shown, a sleeve joint 53 having a conical outer peripheral surface is fixedly connected to the proximal end of the proximal spring wire tube section 51, and the sleeve joint 53 is then fixedly connected to the core wire 4; in other optional implementations, such as Figure 3 As shown, the distal end of the proximal spring wire tube segment 51 and the proximal end of the distal spring wire tube segment 52 are spaced apart from each other, the stopper 6 is disposed between the proximal spring wire tube segment 51 and the distal spring wire tube segment 52, the proximal end of the stopper 6 is fixed or integrally connected to the distal end of the proximal spring wire tube segment 51, the distal end of the stopper 6 is fixed or integrally connected to the proximal end of the distal spring wire tube segment 52 (i.e., the proximal end of the proximal large-diameter spring wire tube segment 521), and the proximal end of the proximal spring wire tube segment 51 is fixedly connected to the core wire 4. Further, the stopper 6 includes a proximal small-diameter segment, a middle expanded-diameter segment, and a distal small-diameter segment sequentially connected along the axial direction of the core wire 4; for example, referring to Figure 4 In some optional embodiments, the stopper 6 is in the shape of a spindle with a cylindrical middle portion in the axial direction and tapered ends; or, referring to Figure 5 , the stopper 6 is spherical; or, refer to Figures 1 to 3 The limit member 6 includes a proximal conical tube section 61 and a distal conical tube section 62 which are axially connected in sequence. The diameter of the proximal conical tube section 61 gradually increases from the proximal end to the distal end, and the diameter of the distal conical tube section 62 gradually decreases from the proximal end to the distal end, and the maximum diameter of the proximal conical tube section 61 is smaller than the maximum diameter of the distal conical tube section 62.

[0056] Reference Figures 1 to 3 The balloon catheter 91 is sleeved on the outside of the core wire 4 , and the proximal end of the balloon catheter 91 is provided with a filling interface 94 connected with its balloon 92 ; the distal end face of the balloon catheter 91 is blocked at the proximal side of the middle expanded diameter section of the limiter 6 .

[0057] Reference Figure 6 , combined with Figure 1 The quickly detachable handle 100 includes a handle assembly 110, a handle assembly 2 120 and a locking assembly 130. The handle assembly 2 120 includes a second main handle 121 having an axial through hole; the proximal end of the balloon catheter 91 is connected to the second main handle 121 in a detachable manner. The handle assembly 1 110 includes a first main handle 1 having an axial through hole and a positioning assembly 2 installed on the first main handle 1; the first main handle 1 is arranged on the proximal side of the second main handle 121, the core wire 4 passes through the axial through hole of the first main handle 1, the axial through hole of the second main handle 121 and the balloon catheter, and the positioning assembly 2 can position or release the core wire 4 on the first main handle 1. The locking assembly 130 is installed on the first main handle 1 and / or the second main handle 121, and is used to lock or unlock the first main handle 1 on the second main handle 121. The axial relative sliding of the first main handle 1 and the second main handle 121 can make the distal end surface of the balloon catheter 91 abut against or away from the middle expanded diameter section of the stopper 6.

[0058] 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:

[0059] Before use, the balloon catheter 91 is sleeved on the outside of the core wire 4, and the proximal end of the balloon catheter 91 is connected to the second main handle 121; the core wire 4 is passed through the axial through hole of the second main handle 121 and the axial through hole of the first main handle 1 in the proximal direction, and the core wire 4 is positioned on the first main handle 1 by using the positioning assembly 2; the first main handle 1 and the second main handle 121 are axially relatively slid to make the distal end face of the balloon catheter 91 abut against the middle expanded diameter section of the stopper 6, and then the first main handle 1 is locked to the second main handle 121 by using the locking assembly 130; the balloon catheter 91 is kept in an unfilled state;

[0060] 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 balloon catheter 91 of this embodiment is inserted into the guide sheath, and the guide sheath is adjusted so that the distal end of the core wire 4 of this embodiment is nearly perpendicular to the coating of the aortic stent graft to be fenestrated in situ;

[0061] In this process, the core wire 4 is positioned at the first main handle 1 by the positioning component 2, and the first main handle 1 and the second main handle 121 are locked together by the locking component 130. The core wire 4 can be operated by holding the first main handle 1 and / or the second main handle 121 of the quickly detachable handle 100, which is easier for the operator to hold and more convenient to operate. In addition, since the core wire 4 is also sheathed with a balloon catheter 91, even if the balloon 92 is not filled, it is equivalent to increasing the diameter of the core wire 4, thereby increasing the supporting force of the core wire 4 in the guide sheath and improving the positioning accuracy of the core wire 4.

[0062] Then, in the first step, the core wire 4 is pushed distally by holding the quickly detachable handle 100, so that the distal end of the core wire 4 punctures the membrane of the aortic stent graft until the stopper 6 enters or passes through the puncture hole punctured in the membrane by the distal end of the core wire 4;

[0063] In this process, since the outer portion of the distal end of the core wire 4 is spirally wrapped with the spring wire 5, the distal structural strength of the core wire 4 is enhanced, and the membrane can be easily and quickly broken, and there is a certain amount of elasticity between the spring coils of the spring wire 5, so that the distal structure of the core wire 4 is not too hard (still has a certain degree of flexibility) to meet the delivery requirements of the core wire 4 inside the blood vessel; in addition, since the distal spring wire tube section 52 of the spring wire 5 spirally wrapped around the distal end of the core wire 4 includes a proximal large-diameter spring wire tube section 521, a middle variable-diameter spring wire tube section 522 and a distal small-diameter spring wire tube section 523, the distal end of the core wire 4 is provided with a plurality of spring wire segments 524, and the distal end of the core wire 4 is provided with a plurality of spring wire segments 526, and the distal end of the core wire 4 is provided with a plurality of spring wire segments 527, and the distal end of the core wire 4 is provided with a plurality of spring wire segments 528, and the distal end of the core wire 4 is provided with a plurality of spring wire segments 529, and the distal end of the core wire 4 is provided with a plurality of spring wire segments 521 ...8, and the distal end of the core wire 4 is provided with a plurality of spring wire segments 529, and the distal end of the core The distal end of the distal small-diameter spring wire tube section 523 is fixedly connected to the distal end of the core wire 4, and the stopper 6 is arranged on the proximal side of the proximal large-diameter spring wire tube section 521, so that the spring wire 5 forms a tapered diameter-reducing inclined surface with a diameter gradually decreasing from the proximal end to the distal end at the intersection of the middle diameter-reducing spring wire tube section 522 and the distal small-diameter spring wire tube section 523. After the distal end of the core wire 4 punctures a puncture hole on the coating, the tapered diameter-reducing inclined surface can quickly guide the proximal large-diameter spring wire tube section 521 and the stopper 6 through the puncture hole to preliminarily expand the puncture hole;

[0064] The second step is to fill the balloon 92. Since the distal end surface of the balloon catheter 91 abuts against the middle diameter expansion section of the stopper 6, the puncture hole can be further enlarged by the balloon 92.

[0065] After the above operations are completed, the pressure of the balloon 92 is released, and then the first main handle 1 is unlocked from the second main handle 121 by using the locking assembly 130, the positioning of the core wire 4 by the positioning assembly 2 is released, and the first main handle 1 and the second main handle 121 are separated from the core wire 4 and the proximal end of the balloon catheter 91, and then the balloon catheter 91 is withdrawn from the core wire 4, and the branch stent graft or other post-treatment devices can be further inserted through the core wire 4;

[0066] During this process, since the core wire 4 is positioned on the first main handle 1 by the positioning assembly 2, the proximal end of the balloon catheter 91 is connected to the second main handle 121 in a detachable manner, and a locking assembly 130 is provided between the first main handle 1 and the second main handle 121, thereby, the first main handle 1 and the second main handle 121 can be detached from the core wire 4 and the balloon catheter 91 respectively without interfering with each other. When it is necessary to remove the balloon catheter 91 and insert other subsequent instruments along the core wire 4, there is no need to repeatedly remove and insert the core wire 4, thereby simplifying the surgical steps and improving the surgical efficiency.

[0067] In summary, the in situ fenestration and membrane rupture system of the aortic stent graft provided in the present embodiment can improve the positioning accuracy of the guide wire at the fenestration and membrane rupture point of the stent graft during the in situ fenestration surgery of the stent graft and quickly rupture the membrane, and can simultaneously expand the puncture hole. At the same time, a single guide wire (core wire 4) 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.

[0068] In some optional implementations of the present embodiment, the limiter 6 and the spring wire 5 are formed by integrally winding a metal wire. In other optional implementations of the present embodiment, the limiter 6 is a metal part or a polymer injection-molded part.

[0069] In some optional implementations of this embodiment, the portion of the core wire 4 located inside the spring wire 5 is in a shape that changes in diameter synchronously with the spring wire 5 .

[0070] In some optional implementations of the present embodiment, the guide wire also includes a guide head 7, the distal end of the distal spring wire tube segment 52 and the distal end of the core wire 4 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 can be prevented that the connection between the distal end of the distal spring wire tube segment 52 and the distal end of the core wire 4 pierces the inner wall of the blood vessel during the transmission of the guide wire in the blood vessel.

[0071] In some optional implementations of the present embodiment, at least one of the five, namely, the proximal end of the proximal spring wire tube segment 51, the proximal end of the limiter 6, the distal end of the limiter 6, the proximal end of the distal small-diameter spring wire tube segment 523, and the distal end of the distal small-diameter spring wire tube segment 523, is fixedly connected with a developing ring 8 to indicate each point under X-ray to help the surgeon perform surgery accurately.

[0072] In the present embodiment, there are a variety of specific detachable connection modes between the proximal end of the balloon catheter 91 and the distal end of the second main handle 121. Since the first main handle 1 and the second main handle 121 can be locked or unlocked by the locking assembly 130, the second main handle 121 and the first main handle 1 can move independently without interfering with each other. On this basis, the proximal end of the balloon catheter 91 and the distal end of the second main handle 121 can be screwed or plugged together, wherein, optionally, a Luer connector 93 is provided at the proximal end of the balloon catheter 91, and a Luer connector 2 1211 is provided at the distal end surface of the second main handle 121, and the Luer connector 1 93 is screwed with the Luer connector 2 1211; the Luer connector is a commonly used connector for medical devices, which is convenient for mass production, and the appropriate balloon catheter 91 and Luer connector 2 1211 can be selected for assembly according to actual needs, which is more flexible to use. However, those skilled in the art should understand that, in other optional implementations of the present embodiment, the proximal end of the balloon catheter 91 and the distal end of the second main handle 121 may also be connected by other means, for example but not limited to, a threaded joint with an external thread is respectively provided at the distal end of the second main handle 121 and the proximal end of the balloon catheter 91, and a locking ring with an internal thread is threadedly sleeved on the external thread of the threaded joint at the distal end of the second main handle 121, so that the threaded external joint at the distal end of the second main handle 121 is docked with the threaded external joint at the proximal end of the balloon catheter 91, and then the locking ring is rotated so that the proximal end of the locking ring is threadedly connected to the threaded external joint at the distal end of the second main handle 121, and the distal end of the locking ring is threadedly connected to the threaded external joint at the proximal end of the balloon catheter 91; or, other detachable connection methods are used for connection.

[0073] In this embodiment, the locking assembly 130 also has a variety of optional implementations, such as but not limited to a buckle structure at the distal end of the first main handle 1 and / or the proximal end of the second main handle 121, which are mutually engaged when docked. However, 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 the action when unlocking to reduce damage to the patient, in some optional implementations of this embodiment, such as Figure 6As shown, the locking assembly 130 includes a middle sleeve 131, a push-pull handle 132 and an elastic strip 133. A side wall through hole connecting the outer side wall of the second main handle 121 and the axial through hole is also provided on the second main handle 121; the elastic strip 133 is arranged inside the axial through hole of the second main handle 121 along the axial direction of the second 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 second main handle 121; a pressing protrusion 1331 is provided on one side surface of the elastic strip 133 facing the outside of the side wall through hole of the second main handle 121, and the pressing protrusion 1331 passes through the side wall through hole of the second main handle 121 and extends to the outside of the second main handle 121; a limiting protrusion 1332 protruding inwardly along the radial direction of the second main handle 121 is provided at the proximal end of the elastic strip 133. The push-pull handle 132 is sleeved outside the second main handle 121 and can slide axially relative to the second main handle 121. The proximal end of the middle sleeve 131 is rotatably connected to the first main handle 1, and the middle sleeve 131 is axially limited to the first main handle 1, and the distal end section of the middle sleeve 131 is inserted into the axial through hole of the second main handle 121, and a thread groove 1310 is provided on the outer circumference of the distal end 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 first main handle 1, and the middle sleeve 131 is axially limited to the first main handle 1" includes but is not limited to providing an extended pipe section at the distal end of the first 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 the convenience 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 second 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 interlocked. When the second 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 first main handle 1 and the second main handle 121, the axial distance between the first main handle 1 and the second main handle 121 can also be axially fine-tuned by rotating the middle sleeve 131 in the locked state of the two, so as to correct the positional offset that may occur at the distal end of the balloon catheter 91 after the balloon 92 is filled, and ensure that the balloon 92 can smoothly enter the puncture hole together with the limiting member 6.

[0074] 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 limiting flange 1212 is provided on the proximal outer peripheral surface of the second main handle 121, a magnetic member 1214 is provided on the distal surface of the limiting flange 1212, a limiting flange 2 1213 is provided on the distal outer peripheral surface of the second main handle 121, and a magnetic member 2 1215 is provided on the proximal surface of the limiting flange 2 1213; the push-pull handle member 132 is made of a material that can attract each other with the magnetic member 1214 and the magnetic member 2 1215 respectively, or a third magnetic member that can attract each other with the magnetic member 1214 and the magnetic member 2 1215 is provided on the push-pull handle member 132.

[0075] In addition, in the present embodiment, in the handle assembly 110, the positioning assembly 2 also has a variety of optional structural types, but it is necessary to satisfy the requirement of being able to position or release the proximal segment of the thinner core wire 4 in the inner wall of the axial through hole of the first main handle 1. The optional structures include but are not limited to providing a screw with an external thread on the outside of the first main handle 1 and connecting a rotating cover with the external thread of the screw, so that the proximal segment of the core wire 4 is wound around the screw, and then the core wire 4 is rotated and fixed by the rotating cover. When the core wire 4 needs to be separated from the first main handle 1, the rotating cover can be unscrewed. Alternatively, other optional structural types can be used.

[0076] Continue to refer to Figure 6 In order to facilitate the operation of the surgeon and ensure high surgical efficiency, in some optional implementations of this embodiment, the positioning assembly 2 includes a positioning handle member 21, a spring member 22, a hose 23 and a limit assembly 3. A side wall through hole connecting the outer wall of the first main handle 1 and the axial through hole is also provided on the first main handle 1; the hose 23 is passed through and fixed inside the axial through hole of the first main handle 1, and the core wire 4 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 spring member 22 is connected to the pressing block 211, and the other end is connected to the outer wall of the first main handle 1; the pressing rod 212 passes through the side wall through hole of the first 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 spring member 22 is compressed and the end of the pressure rod 212 away from the pressure block 211 is radially inwardly squeezed on the hose 23 along the first main handle 1, and the hose 23 is deformed, thereby pressing the core wire 4 inside the hose 23 to achieve positioning of the core wire 4; when the positioning handle member 21 is in the second position, the spring member 22 rebounds to a free state and the end of the pressure rod 212 away from the pressure block 211 releases the hose 23, thereby releasing the core wire 4; the limiting component 3 is movably installed on the outside of the first main handle 1, and the limiting component 3 can lock or release the positioning handle member 21 to the first main handle 1, so that the positioning handle member 21 remains in the above-mentioned first position or second position.

[0077] Among them, there are many optional structures of the limit component 3, for example but not limited to, a plurality of engaging protrusions or a plurality of engaging grooves arranged radially along the first main handle 1 are provided on one side of the positioning handle member 21, and the limit component 3 is axially slidably installed on the outer wall of the first main handle 1. When the limit component 3 slides between two adjacent engaging protrusions or inside any engaging groove, the positioning handle member 21 can be locked to the first main handle 1, and the first main handle 1 can be released by sliding in the opposite direction.

[0078] For ease of operation, in some optional implementations of this embodiment, the limiting component 3 is as follows: Figure 6 The figure shows that it includes a spring component 2 31 and a limit handle component 32; the limit handle component 32 is arranged on one axial side of the first main handle 1, and the limit handle component 32 is rotatably installed on the first main handle 1 through a rotating shaft; the spring component 2 31 extends radially along the first main handle 1, and one end of the spring component 2 31 is fixedly connected to the limit handle component 32, and the other end is fixedly connected to the outer wall of the first 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 arranged radially at intervals along the first 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 spring member 2 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 first main handle 1, and when the limiting handle member 32 is rotated in a direction away from the positioning handle member 21, the spring member 2 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 also provided on the distal outer wall of the first main handle 1, and the limiting flange 11 is provided with a blocking protrusion 111 facing the proximal direction; the pressure rod 212 is provided with an extension portion 2121 on the side facing the limiting flange 11, and the end of the spring member 22 facing away from the outer wall of the first main handle 1 is fixedly connected to the extension portion 2121, and the extension portion 2121 is limited along the radial direction of the first main handle 1 between the blocking protrusion 111 and the outer wall of the first main handle 1.

[0080] To further increase the positioning reliability of the positioning assembly 2, optionally, a limiting column 2111 extending radially along the first main handle 1 is connected to the pressing block 211, and the limiting column 2111 is inserted into the spring member 22; and / or, and / or, a limiting column 2321 is connected to the limiting handle member 32, and the spring member 231 is sleeved on the limiting column 2321. The limiting column 2321 should not be too long, otherwise it will block the limiting handle member 32 from flipping around its rotation axis.

[0081] In order to enhance the positioning effect of the core wire 4, in some optional implementations of the present embodiment, the positioning assembly 2 includes two groups symmetrically arranged radially opposite to each other on the first main handle 1, so as to form an extrusion force on the core wire 4 on both sides of the rubber tube 23 that are symmetrical in the radial direction.

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

[0083] 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 system for an aortic stent graft, characterized in that: It comprises a guide wire, a balloon catheter (91) and a quickly detachable handle (100); The guide wire comprises a core wire (4), a spring wire (5) and a stopper (6); The spring wire (5) is spirally wrapped around the outer portion of the distal end of the core wire (4) and is tubular, comprising a proximal spring wire tube section (51) and a distal spring wire tube section (52); the distal spring wire tube section (52) comprises a proximal large-diameter spring wire tube section (521), a middle reduced-diameter spring wire tube section (522) and a distal small-diameter spring wire tube section (523) which are sequentially connected along the axial direction of the core wire (4); the distal end of the distal small-diameter spring wire tube section (523) is fixedly connected to the distal end of the core wire (4); The limiting member (6) is sleeved on the outside of the distal end section of the core wire (4), wherein the limiting member (6) is arranged on the proximal side of the proximal spring wire tube section (51) and the proximal end of the limiting member (6) is fixedly connected to the core wire (4); or, the limiting member (6) is arranged between the proximal spring wire tube section (51) and the distal spring wire tube section (52), the proximal end of the limiting member (6) is fixedly connected or integrally connected to the distal end of the proximal spring wire tube section (51), the distal end of the limiting member (6) is fixedly connected or integrally connected to the proximal end of the distal spring wire tube section (52), and the proximal end of the proximal spring wire tube section (51) is fixedly connected to the core wire (4); The limiting member (6) comprises a proximal small-diameter section, a middle expanded-diameter section and a distal small-diameter section which are sequentially connected along the axial direction of the core wire (4); The balloon catheter (91) is sleeved on the outside of the core wire (4), and the proximal end of the balloon catheter (91) is provided with a filling interface (94) which is in communication with the balloon (92); the distal end surface of the balloon catheter (91) is blocked at the proximal side of the middle expanded diameter section of the stopper (6); The quickly detachable handle (100) comprises a handle component 1 (110), a handle component 2 (120) and a locking component (130); The handle assembly 2 (120) comprises a second main handle (121) having an axial through hole; the proximal end of the balloon catheter (91) is connected to the second main handle (121) in a detachable manner; The handle assembly (110) comprises a first main handle (1) having an axial through hole and a positioning assembly (2) mounted on the first main handle (1); the first main handle (1) is arranged on the proximal side of the second main handle (121), the core wire (4) passes through the axial through hole of the first main handle (1), the axial through hole of the second main handle (121) and the balloon catheter (91), and the positioning assembly (2) is capable of positioning or releasing the core wire (4) on the first main handle (1); The locking assembly (130) is mounted on the first main handle (1) and / or the second main handle (121), and is used to lock or unlock the first main handle (1) to the second main handle (121); Axially sliding the first main handle (1) and the second main handle (121) relative to each other can cause the distal end surface of the balloon catheter (91) to abut against or move away from the middle expanded diameter section of the stopper (6).

2. The in situ fenestration and membrane rupture system for aortic stent graft according to claim 1, characterized in that: The limiting member (6) and the spring wire are formed by integrally winding a metal wire, or the limiting member (6) is a metal member or a polymer injection molded member.

3. The in situ fenestration and membrane rupture system for aortic stent graft according to claim 1, characterized in that: The limiting member (6) is in the shape of a spindle with a cylindrical middle portion in the axial direction and conical ends; Alternatively, the limiting member (6) is spherical; Alternatively, the stopper (6) comprises a proximal conical tube section (61) and a distal conical tube section (62) which are axially connected in sequence, the proximal conical tube section (61) gradually increases in diameter from the proximal end to the distal end, the distal conical tube section (62) gradually decreases in diameter from the proximal end to the distal end, and the maximum diameter of the proximal conical tube section (61) is smaller than the maximum diameter of the distal conical tube section (62).

4. The in situ fenestration and membrane rupture system for aortic stent graft according to claim 1, characterized in that: The portion of the core wire (4) located inside the spring wire (5) is in a shape that changes diameter synchronously with the spring wire (5); And / or, the guide wire further comprises a guide head (7), the distal end of the distal spring wire tube section (52) and the distal end of the core wire (4) 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; And / or, at least one of the five, namely, the proximal end of the proximal spring wire tube segment (51), the proximal end of the limiting member (6), the distal end of the limiting member (6), the proximal end of the distal small-diameter spring wire tube segment (523), and the distal end of the distal small-diameter spring wire tube segment (523), is fixedly connected to a developing ring (8).

5. The in situ fenestration and membrane rupture system for aortic stent graft according to claim 1, characterized in that: The proximal end of the balloon catheter (91) is provided with a Luer connector 1 (93), the distal end surface of the second main handle (121) is provided with a Luer connector 2 (1211), and the Luer connector 1 (93) is screwed to the Luer connector 2 (1211); The locking assembly (130) comprises a middle sleeve (131), a push-pull handle (132) and an elastic pressure strip (133); The second main handle (121) is also provided with a side wall through hole connecting the outer wall of the second main handle (121) and the axial through hole; the elastic pressure strip (133) is arranged inside the axial through hole of the second main handle (121) along the axial direction of the second 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 second main handle (121); the elastic pressure strip (133) faces the outside of the side wall through hole of the second main handle (121) A pressing protrusion (1331) is provided on one side surface of the second main handle (121), and the pressing protrusion (1331) passes through the through hole of the side wall of the second main handle (121) and extends to the outside of the second main handle (121); a limiting protrusion (1332) protruding radially inwardly along the second 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 second main handle (121) and can slide axially relative to the second main handle (121); The proximal end of the middle sleeve (131) is rotatably connected to the first main handle (1), and the middle sleeve (131) is axially limited to the first main handle (1), the distal end section of the middle sleeve (131) is inserted into the axial through hole of the second main handle (121), and a thread groove (1310) is provided on the outer circumferential surface of the distal end section of the middle sleeve (131); The push-pull handle (132) has a locking position and an unlocking position. When the second 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 second 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).

6. The in situ fenestration and membrane rupture system for aortic stent graft according to claim 5, characterized in that: A limiting flange 1 (1212) is provided on the proximal outer circumference of the second main handle (121), a magnetic member 1 (1214) is provided on the distal end surface of the limiting flange 1 (1212), a limiting flange 2 (1213) is provided on the distal outer circumference of the second main handle (121), and a magnetic member 2 (1215) is provided on the proximal end surface of the limiting flange 2 (1213); The push-pull handle member (132) is made of a material capable of attracting the first magnetic member (1214) and the second magnetic member (1215) respectively, or the push-pull handle member (132) is provided with a third magnetic member capable of attracting the first magnetic member (1214) and the second magnetic member (1215).

7. The in situ fenestration and membrane rupture system for aortic stent graft according to claim 1, characterized in that: In the handle assembly 1 (110), the positioning assembly (2) comprises a positioning handle component (21), a spring component 1 (22), a rubber hose (23) and a limit assembly (3); The first main handle (1) is also provided with a side wall through hole connecting the outer wall of the first main handle (1) and the axial through hole; the rubber tube (23) is passed through and fixed inside the axial through hole of the first main handle (1), and the core wire (4) 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 spring member (22) is connected to the pressing block (211), and the other end is connected to the outer wall of the first main handle (1); the pressing rod (212) passes through a through hole in the side wall of the first 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 spring member (22) is compressed and the pressing rod (212) is The end facing away from the pressing block (211) is pressed radially inwardly along the first main handle (1) against the rubber hose (23); when the positioning handle member (21) is in the second working position, the spring member (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 outside the first main handle (1), and the limiting assembly (3) is capable of locking or releasing the positioning handle member (21) to the first main handle (1).

8. The in situ fenestration and membrane rupture system for aortic stent graft according to claim 7, characterized in that: The limiting assembly (3) comprises a second spring component (31) and a limiting handle component (32); The limit handle member (32) is arranged on one axial side of the first main handle (1), and the limit handle member (32) is rotatably mounted on the first main handle (1) via a rotating shaft; the second spring member (31) extends along the radial direction of the first main handle (1), and one end of the second spring member (31) is fixedly connected to the limit handle member (32), and the other end is fixedly connected to the outer side wall of the first main handle (1); A surface of the limiting handle member (32) facing the positioning handle member (21) is provided with a plurality of sawtooth-shaped grooves (320) arranged at intervals along the radial direction of the first main handle (1); a surface of the positioning handle member (21) facing the limiting handle member (32) is provided with at least one sawtooth-shaped protrusion (210); when the second spring member (31) is in a free state, the sawtooth-shaped protrusion (210) is engaged with any of the sawtooth-shaped grooves (320).

9. The in situ fenestration and membrane rupture system for the aortic stent graft according to claim 8, characterized in that: The distal outer wall of the first main handle (1) is further provided with a limiting flange (11), and the limiting flange (11) is provided with a blocking protrusion (111) facing the proximal direction; An extension portion (2121) is provided on a side of the pressure rod (212) facing the limiting flange (11); an end of the spring member (22) facing away from the outer wall of the first main handle (1) is fixedly connected to the extension portion (2121); and the extension portion (2121) is limited in the radial direction of the first main handle (1) between the blocking protrusion (111) and the outer side wall of the first main handle (1).

10. The in situ fenestration and membrane rupture system for aortic stent graft according to claim 8, characterized in that: The pressure block (211) is connected to a limiting column 1 (2111) extending radially along the first main handle (1), and the limiting column 1 (2111) is inserted into the spring component 1 (22); and / or the limiting handle component (32) is connected to a limiting column 2 (321), and the spring component 2 (31) is sleeved outside the limiting column 2 (321).

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