A membrane rupture device for a covered stent

Abstract

The present invention discloses a membrane rupture device for a coated stent, which relates to the technical field of medical devices, and comprises a catheter, wherein a continuous elongated guidewire cavity and a needle cavity are arranged between a first unit and a second unit; the guidewire cavity and the needle cavity are arranged at intervals; a guidewire outlet communicating with the guidewire cavity is arranged on the side wall of the second unit, and a needle outlet communicating with the needle cavity is arranged on the side wall of the second unit opposite to the guidewire outlet; the needle cavity of the second unit is provided with an arc guide rail; the guidewire can be slidably placed in the guidewire cavity; the membrane rupture needle can be slidably placed in the needle cavity; the distal end of the membrane rupture needle has a needle blade portion, and the membrane rupture needle body near the needle blade portion includes an arc pre-bent portion; the arc pre-bent portion is arranged in cooperation with the arc guide rail. The arc pre-bent portion of the membrane rupture needle of the present invention is arranged in cooperation with the arc guide rail of the catheter, so that the membrane rupture needle and the catheter are circumferentially limited, and the two are twisted synchronously, which can effectively avoid the problem of the membrane rupture needle changing direction after the catheter is twisted.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a membrane rupturing device for a coated stent. Background Art

[0002] In the modern medical field, the treatment of vascular diseases has always been an important and complex challenge. With the advancement of medical technology, vascular intervention technology, as a minimally invasive treatment method, has been widely used in the treatment of various vascular diseases. Among them, vascular intervention technology often requires the use of multi-lumen tubes as auxiliary tools to introduce, contain or transport related instruments and fluids into the target blood vessel lumen. As an important vascular intervention device, stent grafts play a key role in the treatment of diseases such as aneurysms, arterial dissections, and vascular rupture and bleeding. However, the application of stent grafts also faces a series of technical difficulties, especially in the maintenance and adjustment process after the implantation of the stent graft. How to safely and effectively perform membrane rupture operations has become a problem that needs to be solved urgently.

[0003] The membrane rupture operation generally uses a membrane rupture needle to puncture the membrane, and the membrane rupture needle enters the membrane rupture position through a catheter. However, in the actual operation process, it is sometimes necessary to twist the catheter to drive the membrane rupture needle to face the membrane rupture position. When the catheter is twisted, the membrane rupture needle inserted in it often cannot follow the synchronous twisting of the catheter, which easily causes the membrane rupture needle and the catheter to change direction relative to each other, making it impossible for the membrane rupture needle to face the membrane rupture position, which is inconvenient to use. Therefore, it is urgent to design a device that can effectively avoid the problem of the membrane rupture needle changing direction relative to the catheter after the catheter is twisted. Summary of the invention

[0004] The purpose of the present invention is to provide a membrane rupture device for a coated stent to solve the problems existing in the above-mentioned prior art. The arc-shaped pre-bent portion of the membrane rupture needle is matched with the arc-shaped guide rail of the catheter to limit the circumferential position between the membrane rupture needle and the catheter, and the two are twisted synchronously, which can effectively avoid the problem of the membrane rupture needle changing direction after the catheter is twisted.

[0005] To achieve the above object, the present invention provides the following solutions:

[0006] The present invention provides a stent graft membrane rupture device, comprising:

[0007] The catheter comprises a first unit and a second unit connected in sequence from the proximal end to the distal end; the material hardness of the second unit is greater than that of the first unit; a slender guidewire cavity and a needle cavity are provided in the catheter, which are continuous between the first unit and the second unit; the guidewire cavity and the needle cavity are arranged at intervals; a guidewire outlet communicating with the guidewire cavity is provided on the side wall of the second unit, and a needle outlet communicating with the needle cavity is provided on the side wall of the second unit opposite to the guidewire outlet; the needle cavity of the second unit is provided with an arc guide rail;

[0008] The guidewire can be slidably placed in the guidewire cavity; after the distal end of the guidewire enters the hollow anatomical structure from the guidewire cavity through the guidewire outlet, the guidewire can inhibit the circumferential torsion of the catheter;

[0009] The membrane-breaking needle can be slidably placed in the needle cavity; the distal end of the membrane-breaking needle has a needle blade, and the membrane-breaking needle body near the needle blade includes an arc-shaped pre-bent portion; the arc-shaped pre-bent portion is arranged in cooperation with the arc-shaped guide rail.

[0010] Optionally, the distal segment of the guidewire includes a first guidewire segment and a second guidewire segment connected in sequence; the first guidewire segment is the tip of the guidewire and is softer than the second guidewire segment.

[0011] Optionally, the stent graft membrane rupture device has a first state;

[0012] In the first state, the distal end of the second guidewire segment slides away from the catheter through the guidewire outlet, and the proximal end of the second guidewire segment remains in the guidewire cavity.

[0013] A stent graft membrane rupture device, comprising:

[0014] The catheter comprises a first unit and a second unit connected in sequence from the proximal end to the distal end; the material hardness of the second unit is greater than that of the first unit; a slender guidewire cavity and a needle cavity are provided in the catheter, which are continuous between the first unit and the second unit; the guidewire cavity and the needle cavity are arranged at intervals; a guidewire outlet communicating with the guidewire cavity is provided on the side wall of the second unit, and a needle outlet communicating with the needle cavity is provided on the side wall of the second unit opposite to the guidewire outlet; the needle cavity of the second unit is provided with an arc guide rail;

[0015] The guidewire can be slidably placed in the guidewire cavity; the distal end of the guidewire includes a first guidewire segment and a second guidewire segment connected in sequence; the first guidewire segment is the tip of the guidewire and is softer than the second guidewire segment;

[0016] The membrane-breaking needle can be slidably placed in the needle cavity; the distal end of the membrane-breaking needle has a needle blade, and the membrane-breaking needle body near the needle blade includes an arc-shaped pre-bent portion; the arc-shaped pre-bent portion is arranged in cooperation with the arc-shaped guide rail.

[0017] Optionally, the membrane rupturing needle has a hollow inner cavity that runs through both ends of the distal and proximal ends; and the arc-shaped pre-bent portion includes staggered slits.

[0018] Optionally, it also includes a second guide wire inserted into the inner cavity of the membrane rupturing needle.

[0019] Optionally, the cutting edge of the membrane rupturing needle is directed toward the proximal end or the distal end of the catheter.

[0020] Optionally, the arcuate guide rail includes a slide groove block near the distal end of the catheter; the slide groove block is used to resist the force exerted by the membrane rupture needle on the arcuate guide rail toward the distal end of the catheter.

[0021] Optionally, the first unit is a polymer material, and the second unit is a metal material.

[0022] Optionally, the catheter further includes a third unit connected to the distal end of the second unit, the third unit is in a frustum shape, and the material hardness of the third unit is less than the material hardness of the first unit.

[0023] Optionally, the proximal section where the third unit is connected to the second unit includes a guide groove continuous with the guide wire cavity; the guide groove is recessed toward the center of the catheter; and the guide groove is used to guide the guide wire into the hollow anatomical structure.

[0024] Optionally, the third unit further includes a developing member having a direction indicator.

[0025] Optionally, the needle outlet is oval or teardrop-shaped.

[0026] Optionally, the cross-section of the catheter is one of circular, elliptical, and regular polygonal; the catheter also includes a bending stiffness balancing cavity located between the guidewire cavity and the needle cavity; the bending stiffness balancing cavity is used to balance the overall axial bending stiffness of the catheter.

[0027] Compared with the prior art, the present invention has achieved the following technical effects:

[0028] The arc pre-bend portion of the membrane-breaking needle of the present invention is arranged in cooperation with the arc-shaped guide rail of the catheter, which can effectively avoid the problem of the membrane-breaking needle changing direction after the catheter is twisted; the arc pre-bend portion and the arc guide rail are arranged in cooperation, which can be understood as the curvature radius of the arc pre-bend portion is similar or close to the curvature radius of the arc guide rail, and the membrane-breaking needle and the catheter are limited in circumferential direction, avoiding the problem of misalignment of the membrane-breaking needle caused by asynchronous twisting; the membrane-breaking needle and the catheter are not limited in axial direction, so that the membrane-breaking needle can move axially in the catheter without affecting the use of the membrane-breaking needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0030] Figure 1 A schematic longitudinal section diagram of a multi-lumen tube for an interventional device according to the present invention;

[0031] Figure 2 A schematic cross-sectional view of a multi-lumen tube for an interventional device according to the present invention;

[0032] Figure 3 Schematic diagram of the partial structure of the membrane rupture device of the stent graft in some embodiments of the present invention;

[0033] Figure 4 Schematic diagram of the partial structure of the membrane rupture device of the stent graft in some embodiments of the present invention;

[0034] Figure 5 A schematic diagram of the cross-sectional structure of the first unit of the membrane rupture device of the stent graft in some embodiments of the present invention;

[0035] Figure 6 In some embodiments of the present invention, the stent graft membrane rupture device Figure 5 AA cross-sectional structural diagram;

[0036] Figure 7 In some embodiments of the present invention, the stent graft membrane rupture device Figure 5 BB cross-sectional structure diagram;

[0037] Figure 8 A schematic diagram of the longitudinal cross-sectional structure of the second unit of the membrane rupture device of the stent graft in some embodiments of the present invention;

[0038] Fig. 9 Schematic diagram of the three-dimensional structure of the guide wire outlet in some embodiments of the present invention;

[0039] Fig.10 Schematic diagram of the three-dimensional structure of the needle outlet in some embodiments of the present invention;

[0040] Fig.11 A three-dimensional schematic diagram of the positional relationship between the guide wire outlet and the guide groove in some embodiments of the present invention;

[0041] Fig.12 A three-dimensional schematic diagram of the positional relationship between the needle outlet and the developing member in some embodiments of the present invention;

[0042] Fig.13 Schematic diagram of the membrane rupture needle structure in some embodiments of the present invention;

[0043] Fig.14 Schematic diagram of the membrane rupture needle structure in some embodiments of the present invention;

[0044] Fig.15 A schematic diagram of a guidewire structure having a first guidewire segment and a second guidewire segment in some embodiments of the present invention;

[0045] Fig.16 Schematic diagram of the three-dimensional structure of the membrane rupture device of the stent graft in some embodiments of the present invention;

[0046] Fig.17 A top view of a membrane rupture device for a coated stent in some embodiments of the present invention;

[0047] Fig.18 for Fig.17 AA cross-sectional diagram of ;

[0048] Fig.19for Fig.17 BB cross-sectional diagram;

[0049] Fig. 20 It is a cross-sectional schematic diagram of the membrane rupture device of the stent graft after the handle shell is removed in some embodiments of the present invention;

[0050] Fig.21 It is a cross-sectional schematic diagram of a three-way component in some embodiments of the present invention;

[0051] Fig. 22 It is a schematic diagram of the longitudinal sliding cooperation between the proximal end of the membrane rupture needle and the membrane rupture needle entrance at the proximal end of the catheter in some embodiments of the present invention;

[0052] Fig.23 It is a schematic diagram of longitudinally pushing the membrane rupturing needle out of the needle outlet by the needle pushing mechanism in some embodiments of the present invention;

[0053] Fig.24 It is a partial schematic diagram of a stent graft membrane rupture device with a second guide wire in some embodiments of the present invention;

[0054] Fig.25 A stent graft membrane rupture device with scale markings in some embodiments of the present invention;

[0055] Fig.26 It is a schematic diagram of a use state of the membrane rupture device of the stent graft of the present invention;

[0056] Fig. 27 It is a schematic diagram of a use state of the membrane rupture device of the stent graft of the present invention;

[0057] Fig.28 It is a schematic diagram of a usage state of the membrane rupture device of the coated stent of the present invention.

[0058] In the figure: 1-handle, 10-guidewire inlet, 11-needle pushing mechanism, 12-housing, 121-scale mark, 1101-tubular body, 1102-manifold, 1103-three-way component, 2-catheter, 201-guidewire cavity, 202-needle cavity, 203-bending stiffness balancing cavity, 204-guidewire outlet, 205-needle outlet, 206-membrane rupture needle inlet, 2100-multi-lumen tube, 2200-cross section, 2210-first cavity cross section, 2220-second cavity cross section, 2230-third cavity cross section, 2110-first cavity, 2120-second cavity, 2 130-third cavity, 2300-multi-lumen tube body, 21-first unit, 22-second unit, 23-third unit, 221-arc guide rail, 222-slide block, 231-guide groove, 232-developing component, 3-aorta, 4-branch artery, 5-coated stent, 6-conical head, 7-helical spring guide wire or stent, 8-membrane rupture needle, 810-needle blade, 811-blade, 812-slit, 820-arc pre-bend portion, 830-inner cavity of membrane rupture needle, 9-guide wire, 910-first guide wire segment, 920-second guide wire segment, 13-second guide wire. DETAILED DESCRIPTION

[0059] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. 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.

[0060] The term "longitudinal" in the embodiments of the present invention refers to the direction of a catheter or multi-lumen tube or handle having a length value in a natural state without external force, and the direction extending from the proximal end to the distal end, or from the distal end to the proximal end, is referred to as "longitudinal". "Transverse" refers to the direction perpendicular to the longitudinal direction. "Cross-section" refers to the transverse section of a catheter or multi-lumen tube or handle. "Proximal end" refers to the end close to the operator outside the body; "distal end" refers to the end away from the operator outside the body.

[0061] The term "catheter" in the embodiments of the present invention refers to a general term including single-lumen tubes and multi-lumen tubes. "Multi-lumen tube" refers to a catheter with a lumen number greater than 1. "First cavity" is also called "guidewire cavity" in a specific embodiment. "Second cavity" is also called "needle cavity" in a specific embodiment. "Hardness" is defined as the resistance of a material or material to indentation when a static load is applied. "Bending stiffness" is a mechanical term used to describe the ratio of the bending moment and beam curvature of a long strip of object. "Flexural rigidity of section" is also called cross-sectional bending stiffness. "Torsion control" is also called manipulability: it refers to the ability to transmit torque from the proximal end of the catheter to the distal end of the catheter (the goal is 1:1 transmission); in layman's terms, it is the ability to control the distal end of the catheter to move forward in the blood vessel or in the direction of the target in the lesion or to align the side wall component with the target when manipulating the proximal end of the catheter.

[0062] After extensive and in-depth research, the applicant found that due to the uneven arrangement of the lumens in the multi-lumen tube, the bending stiffness of the multi-lumen tube in each direction perpendicular to the axis of the multi-lumen tube is different, which further causes the difference in the torsion control performance of the multi-lumen tube as a whole, reducing the torsion control of the multi-lumen tube as a whole. The applicant balanced the bending stiffness of the multi-lumen tube in each direction (circumferential or longitudinal, circumferential and longitudinal) through finite element calculation and rearrangement of the lumens, adding side lumens, thereby improving the torsion control performance of the multi-lumen tube. The applicant also found in specific applications (such as stent-covered membrane rupture devices): within the size range of several groups of multi-lumen tube outer diameters (also known as multi-lumen tube cross-sectional outer diameters) of 1.5mm or 2.0mm or 2.5mm or 3.0 or 3.5mm or 5mm or 6.5mm; in order to ensure that the guidewire cavity and the needle cavity are large enough, the multi-lumen tube is designed into only two cavities (the guidewire cavity and the needle cavity), which will cause the multi-lumen tube to be difficult to bend when there is no force on one side of the cavity; the impact is that twisting the multi-lumen tube during surgery will make the multi-lumen tube unable to twist at a uniform speed, resulting in a sudden turn of a certain angle, and the multi-lumen tube body cannot be stopped at a predetermined position; if two additional auxiliary cavities (hereinafter referred to as bending stiffness balancing cavities or third cavities) are added, the degree of bending under force in all directions of the multi-lumen tube is as similar as possible, which will greatly improve this situation. The multi-lumen tube can be twisted at a uniform speed and stopped at a predetermined position, which is convenient for membrane rupture. Usually, the additional auxiliary cavity is not used to introduce, accommodate or transport related instruments and fluids.

[0063] One object of the present invention is to provide a catheter assembly capable of achieving relatively precise torsion control (good torsion controllability); based on this, the present invention first provides a catheter assembly for an interventional device:

[0064] like Figure 1 and Figure 2As shown, a catheter assembly for interventional instruments includes a slender multi-lumen tube 2100 with proximal and distal ends, and a cross-section 2200 of the multi-lumen tube 2100 is a circular, elliptical, or regular polygonal shape; a first cavity section 2210, a second cavity section 2220, and a third cavity section 2230 are nested in the cross-section 2200 of the multi-lumen tube 2100; the first cavity section 2210, the second cavity section 2220, and the third cavity section 2230 are filled in pairs by a multi-lumen tube body 2300; the first cavity section 2210 extends from the proximal end of the multi-lumen tube 2100 to the distal end of the multi-lumen tube 2100 to form a first cavity 2110, and the first cavity 2110 is used to accommodate or transport a puncture needle, a guide wire 9, a flexible shaft, a micro-guide tube, and a guide wire. tube, fluid, stent, embolization coil, or balloon catheter; the second cavity section 2220 extends from the proximal end of the multi-cavity tube 2100 to the distal end of the multi-cavity tube 2100 to form a second cavity 2120, and the second cavity 2120 is used to accommodate or transport a puncture needle, a guide wire 9, a flexible shaft, a microcatheter, a fluid, a stent, an embolization coil, or a balloon catheter; the third cavity section 2230 extends from the proximal end of the multi-cavity tube 2100 to the distal end of the multi-cavity tube 2100 to form a third cavity 2130, and the third cavity 2130 is used to balance the axial bending stiffness of the multi-cavity tube 2100 as a whole; the area value of the third cavity section 2230 is smaller than the area value of the first cavity section 2210, and smaller than the area value of the second cavity section 2220.

[0065] Furthermore, the first cavity cross-section 2210 is a circle, an ellipse, or a regular polygon; the second cavity cross-section 2220 is a circle, an ellipse, or a regular polygon; the area value of the first cavity cross-section 2210 is greater than or equal to the area value of the second cavity cross-section 2220; the third cavity cross-section 2230 is arranged on one side or both sides of the center line between the first cavity cross-section 2210 and the second cavity cross-section 2220.

[0066] Furthermore, the third cavity cross section 2230 is a circle, an ellipse, or a regular polygon.

[0067] Furthermore, the cross-section 2200 of the multi-lumen tube 2100 is circular, the first lumen cross-section 2210 is circular, the second lumen cross-section 2220 is circular, and the third lumen cross-section 2230 is circular; the center of the first lumen cross-section 2210 and the center of the second lumen cross-section 2220 are both arranged on the same diameter of the multi-lumen tube 2100; at least two independent third lumen cross-sections 2230 are included, and the two third lumen cross-sections 2230 are respectively arranged on both sides of the line connecting the center of the first lumen cross-section 2210 and the center of the second lumen cross-section 2220.

[0068] Furthermore, the centers of the two third cavity sections 2230 are arranged on the same diameter of the multi-cavity tube 2100; the diameter of the multi-cavity tube 2100 where the center of the third cavity section 2230 is located is perpendicular to the diameter of the multi-cavity tube 2100 where the center of the first cavity section 2210 is located.

[0069] Furthermore, the multi-lumen tube body 2300 near the distal end does not have the third cavity 2130 ; the first cavity 2110 penetrates both end surfaces of the multi-lumen tube body 2300 .

[0070] Furthermore, the second cavity 2120 near the distal end of the multi-cavity tube body 2300 penetrates the side wall of the multi-cavity tube 2100 to form a side through hole to communicate with the outside.

[0071] Furthermore, the material hardness of the distal end section of the multi-lumen tube 2100 is greater than the material hardness of the proximal end section of the multi-lumen tube 2100; the outer diameter size range of the cross section 2200 of the multi-lumen tube 2100 is 0.5 mm to 10 mm.

[0072] Furthermore, the side through holes are arranged in a region where the hardness of the side wall material is greater than the hardness of the proximal end section material of the multi-lumen tube 2100 .

[0073] In some specific applications, the catheter 2 or catheter assembly having the bending stiffness balancing cavity 203 is used in a membrane rupture device of a coated stent 5; the membrane rupture device of the coated stent 5 also includes a guide wire and a membrane rupture needle 8; the guide wire can be slidably placed in the first cavity 2110; the membrane rupture needle 8 can be slidably placed in the second cavity 2120.

[0074] For the in situ fenestration of the covered stent 5, the existing technologies include: antegrade in situ fenestration by needle (reported by Tilo Kölbel of Germany in 2013), using a transseptal puncture needle for puncture during EVAR; pre-placed bare stent-assisted laser in situ fenestration technology (reported by a French hospital in 2018, N=16), which is to implant a bare stent in the target blood vessel for auxiliary positioning; some surgeons also pre-place a guidewire in the branch vessel and use a long sheath to assist in puncture.

[0075] After extensive and in-depth research, the applicant found that antegrade in situ fenestration (i.e., the puncture needle punctures the window from the stent cavity to the outside) has many shortcomings: high positioning requirements; many anatomical restrictions: the angle between the branch vessel and the aorta 3 affects the feasibility of in situ fenestration, etc.; easy puncture of the blood vessel; ischemia of the branch vessel; the puncture point is located near the apex of the stent: the balloon cannot follow up the expansion / the branch stent cannot be fully deployed. Although retrograde in situ fenestration can be achieved by pre-placing a guidewire in the branch vessel and cooperating with a long sheath to assist in puncture; however, the long sheath has insufficient positioning ability, so that after the long sheath is in place to release the main stent, its distal end has a certain probability of deviating from the branch opening, resulting in the window being unable to align with the branch artery 4 (in the in vitro simulation test conducted by the applicant, the long sheath may deviate by nearly 40°). Based on this, the applicant redesigned a retrograde in situ windowing (i.e., the puncture needle punctures the window from the outside of the stent to the inside of the stent cavity) covered stent 5 membrane breaker; the device can achieve puncture from the outside of the stent to the inside without the risk of puncturing the blood vessel, and is less restricted by the anatomical structure of the blood vessel (angle, etc.) (or is not restricted by the anatomical structure); during puncture, the positioning time is reduced, and the branch ischemia time is reduced (reducing the risk of branch vessel ischemia).

[0076] Another object of the present invention is to provide a stent graft 5 membrane rupture device design with excellent comprehensive performance (combining auxiliary positioning function, twist control performance, safety, and high efficiency); based on this, the present invention provides a stent graft 5 membrane rupture device:

[0077] like Figure 3~Figure 8As shown, a membrane rupture device for a coated stent 5 comprises: a catheter 2, the catheter 2 comprises a first unit 21 and a second unit 22 connected in sequence from the proximal end to the distal end; the material hardness of the second unit 22 is greater than the material hardness of the first unit 21; a slender guidewire cavity 201 and a needle cavity 202 are provided in the catheter 2; the guidewire cavity 201 and the needle cavity 202 are arranged at intervals; a guidewire outlet 204 communicating with the guidewire cavity 201 is provided on the side wall of the second unit 22, and a guidewire outlet 204 in communication with the guidewire cavity 201 is provided on the second unit 22 opposite to the guidewire outlet 204 A needle outlet 205 connected to the needle cavity 202 is provided on the side wall; the needle cavity 202 of the second unit 22 is provided with an arc-shaped guide rail 221; a guide wire can be slidably placed in the guide wire cavity 201; after the distal end of the guide wire enters the hollow anatomical structure from the guide wire cavity 201 through the guide wire outlet 204, the guide wire can inhibit the circumferential torsion of the catheter 2; the membrane-breaking needle 8 can be slidably placed in the needle cavity 202; the distal end of the membrane-breaking needle 8 has a needle blade portion 810, and the membrane-breaking needle 8 body near the needle blade portion 810 includes an arc-shaped pre-bent portion 820; the arc-shaped pre-bent portion 820 is arranged in cooperation with the arc-shaped guide rail 221. It can be understood that, compared with the prior art, the integrated design of the auxiliary positioning or limiting component and the membrane rupture device helps the coated stent 5 and the branch blood vessel to obtain the mutually aligned window of the coated stent 5 and the branch blood vessel orifice through a single window opening operation; avoids multiple adjustments of the coated stent 5 after window opening to correct the window of the coated stent 5 so that it is aligned with the branch blood vessel orifice, avoids multiple operations and instrument changes, and saves surgical time. The guide wire is cleverly used as an auxiliary positioning or limiting component, and cooperates with the relatively hard side wall of the distal section of the catheter 2, so that after entering the hollow anatomical structure, it can suppress the circumferential torsion of the catheter 2, so as to ensure that in the process of pushing out the membrane rupture needle 8 to open the window, the guide wire, the catheter 2 and the membrane rupture needle 8 are basically in the same plane or straight line; such a simple structure can achieve the auxiliary positioning function, and at the same time, it also avoids the membrane rupture device from becoming complicated due to the addition of the auxiliary positioning function, and avoids the catheter 2 responsible for delivering the membrane rupture needle 8 from being forced to increase the outer diameter of the cross section 2200 due to the excessive occupation of the lumen space (in other words, the original catheter 2 responsible for delivering the membrane rupture needle 8 does not need to increase the outer diameter of the cross section 2200 too much to achieve the auxiliary positioning function). Compared with the existing straight track push-out needle, the arc pre-bent portion 820 of the membrane rupturing needle 8 and the arc guide rail 221 of the catheter 2 are arranged in cooperation, which can effectively avoid the problem that the needle is easy to change direction after the catheter 2 is twisted; the arc pre-bent portion 820 and the arc guide rail 221 are arranged in cooperation, which can be understood as the curvature radius of the arc pre-bent portion 820 is similar or close to the curvature radius of the arc guide rail 221.

[0078] In some specific applications, such as Figure 9~Figure 15As shown, the distal end of the guidewire includes a first guidewire segment 910 and a second guidewire segment 920 connected in sequence; the first guidewire segment 910 is the tip of the guidewire and is softer than the second guidewire segment 920. It can be understood that a soft guidewire tip is easier to enter the lumen of the branch blood vessel, but a soft guidewire body is not conducive to inhibiting the circumferential torsion of the catheter 2.

[0079] In some specific applications, the membrane rupture device of the coated stent 5 has a first state; in the first state, the distal end of the second guidewire segment 920 slides away from the catheter 2 through the guidewire outlet 204, and the proximal end of the second guidewire segment 920 remains in the guidewire cavity 201. It can be understood that the guidewire and the membrane rupture needle 8 can be separately or simultaneously received in the catheter 2 and delivered to the target blood vessel cavity; the guidewire can be pushed out of the guidewire outlet 204 before the membrane rupture needle 8 to enter the branch vessel, or can be pushed out of the guidewire outlet 204 after the membrane rupture needle 8 to enter the branch vessel, and the former is superior to the latter, especially when the guidewire has a softer guidewire tip than the second guidewire segment 920 (at this time, the second guidewire segment 920 is used to limit / limit / inhibit the circumferential torsion of the catheter 2). The first state of the membrane rupture device of the coated stent 5 is that the guide wire pushes out the catheter 2 and anchors it in the branch blood vessel cavity (hollow anatomical structure); the membrane rupture device of the coated stent 5 also includes a second state, and the second state is that the membrane rupture needle 8 pushes out the catheter 2 to open a window for the coated stent 5 in the first state of the membrane rupture device of the coated stent 5.

[0080] In some specific applications, a membrane rupture device for a coated stent 5 includes: a catheter 2 includes a first unit 21 and a second unit 22 connected in sequence from the proximal end to the distal end; the material hardness of the second unit 22 is greater than the material hardness of the first unit 21; a slender guidewire cavity 201 and a needle cavity 202 are provided in the catheter 2; the guidewire cavity 201 and the needle cavity 202 are arranged at intervals; a guidewire outlet 204 connected to the guidewire cavity 201 is provided on the side wall of the second unit 22, and a guidewire outlet 204 connected to the needle cavity is provided on the side wall of the second unit 22 opposite to the guidewire outlet 204 202 is connected to the needle outlet 205; the needle cavity 202 of the second unit 22 is provided with an arc guide rail 221; the guide wire can be slidably placed in the guide wire cavity 201; the distal end section of the guide wire includes a first guide wire segment 910 and a second guide wire segment 920 connected in sequence; the first guide wire segment 910 is the tip of the guide wire and is softer than the second guide wire segment 920; the membrane rupturing needle 8 can be slidably placed in the needle cavity 202; the distal end of the membrane rupturing needle 8 has a needle blade portion 810, and the membrane rupturing needle 8 body near the needle blade portion 810 includes an arc pre-bent portion 820; the arc pre-bent portion 820 is arranged in coordination with the arc guide rail 221. It can be understood that the guidewire and the membrane-breaking needle 8 can be separately or simultaneously received in the catheter 2 and delivered to the target blood vessel cavity; the guidewire can be pushed out of the guidewire outlet 204 before the membrane-breaking needle 8 to enter the branch blood vessel, or can be pushed out of the guidewire outlet 204 after the membrane-breaking needle 8 to enter the branch blood vessel, and the former is superior to the latter, especially when the guidewire has a softer guidewire tip than the second guidewire segment 920 (in this case, the second guidewire segment 920 is used to limit / position / inhibit the circumferential torsion of the catheter 2). The arc pre-bend portion 820 is arranged in conjunction with the arc guide rail 221, and it can be understood that the curvature radius of the arc pre-bend portion 820 is similar or close to the curvature radius of the arc guide rail 221.

[0081] In some specific applications, the membrane rupture needle 8 has a hollow inner cavity (membrane rupture needle inner cavity 830) that runs through both ends; the arc pre-bend portion 820 includes staggered slits 812. The membrane rupture needle 8 with excellent comprehensive performance is often also beneficial to the efficiency of the membrane rupture device. The structural design of the membrane rupture needle 8 needle body often needs to comprehensively consider many aspects: the hypotube membrane rupture needle 8 is easier to bend; the arc pre-bend portion 820 of the nickel-titanium hypotube is easy to break after cutting; the arc pre-bend portion 820 of the stainless steel hypotube is not easy to bend; combined nickel-titanium tube, one section of the membrane rupture needle 8 is used for puncture, and one section of ordinary tubing.

[0082] In some specific applications, a second guide wire 13 is also included which is passed through the inner cavity 830 of the membrane rupturing needle to facilitate the insertion of a balloon after the window is opened to further expand the window aperture.

[0083] In some specific applications, the cutting edge 811 of the needle blade 810 of the membrane-breaking needle 8 faces the proximal end or the distal end of the catheter 2. It is understandable that when the distal end of the preset second guide wire 13 faces the proximal end of the stent graft 5, the cutting edge 811 of the needle blade 810 of the membrane-breaking needle 8 faces the proximal end of the catheter 2 to avoid the cutting edge 811 from damaging the second guide wire 13; when the distal end of the preset second guide wire 13 faces the distal end of the stent graft 5, the cutting edge 811 of the needle blade 810 of the membrane-breaking needle 8 faces the distal end of the catheter 2 to avoid the cutting edge 811 from damaging the second guide wire 13. The second guide wire 13 can be captured and stretched out of the body by the capture device of the brachial artery access, and then a balloon, stent or other device can be introduced along the second guide wire 13.

[0084] In some specific applications, the arcuate guide rail 221 includes a slide block 222 near the distal end of the catheter 2 ; the slide block 222 is used to resist the force exerted by the membrane rupturing needle 8 on the arcuate guide rail 221 toward the distal end of the catheter 2 .

[0085] In some specific applications, the first unit 21 is a polymer material, and the second unit 22 is a metal material. It can be understood that the first unit 21 is the main body of the proximal section of the catheter 2, and its main function is to accommodate or transport the membrane-breaking needle 8 and the guide wire, and it is also the main body of the twist control operation; the second unit 22 is the main body of the distal section of the catheter 2, which is mainly used for guiding the needle 8 out of the membrane-breaking needle 8. Its side wall needs to cooperate with the guide wire to achieve the function of inhibiting the circumferential torsion of the catheter 2. The realization of these functions requires a material with relatively high hardness to effectively resist the force applied by the membrane-breaking needle 8 toward the distal end of the catheter 2, and resist the deformation of the side wall after the interaction with the guide wire when the catheter 2 is circumferentially torsion.

[0086] In some specific applications, the catheter 2 further includes a third unit 23 connected to the distal end of the second unit 22. The third unit 23 is in a frustum shape, and the material hardness of the third unit 23 is less than the material hardness of the first unit 21. The third unit 23 is mainly used to prevent the distal end of the catheter 2 from damaging the blood vessel due to excessive hardness and to facilitate the distal end of the catheter 2 to be pushed to the target blood vessel cavity. The third unit 23 is also called a TIP head. The material of the third unit 23 is preferably silicone.

[0087] In some specific applications, the proximal section of the third unit 23 connected to the second unit 22 includes a guide groove 231 continuous with the guidewire lumen 201; the guide groove 231 is recessed toward the center of the catheter 2; the guide groove 231 is used to guide the guidewire into the hollow anatomical structure. The embedded imaging point is used to determine the direction (K, C, Z and other structures); the side opening TIP head facilitates the smooth positioning of the guidewire in the target blood vessel.

[0088] In some specific applications, the third unit 23 further includes a developing member 232 having a direction indicator.

[0089] In some specific applications, the needle outlet 205 is elliptical or teardrop-shaped, so that the blade 810 or the arc-shaped pre-bent portion 820 of the membrane-rupturing needle 8 can smoothly pass through the needle outlet 205 .

[0090] In some specific applications, the cross section 2200 of the catheter 2 is a circular, elliptical, or regular polygonal shape; the catheter 2 further includes a bending stiffness balancing cavity 203 located between the guidewire cavity 201 and the needle cavity 202; the bending stiffness balancing cavity 203 is used to balance the overall axial bending stiffness of the catheter 2. It is understandable that adding the bending stiffness balancing cavity 203 to the catheter 2 of the membrane rupture device of the stent graft 5 is helpful for the torsion controllability of the membrane rupture device of the stent graft 5, as described above with respect to the torsion controllability of the multi-lumen tube 2100.

[0091] Another object of the present invention is to provide a design of a membrane rupture device for a stent graft 5 having excellent comprehensive performance (convenient operation by the operator, auxiliary positioning function, high efficiency, and simple structure); based on this, the present invention provides a membrane rupture device for a stent graft 5:

[0092] like Figure 16~Figure 28 As shown, a membrane rupture device for a coated stent 5 comprises: a handle 1 having a longitudinally extending shell 12 for supporting a catheter 2 and a needle pushing mechanism 11; a catheter 2 having a distal end and a proximal end, wherein the proximal end section is fixed to the handle 1, and a cavity is provided inside the catheter 2 that passes through the proximal end and extends toward the distal end, a needle outlet 205 is provided on the side wall of the distal end section of the catheter 2, and a guide wire outlet is provided on the side wall of the catheter 2 opposite to the needle outlet 205, wherein the guide wire outlet can face the branch artery 4, and the needle outlet 205 can The membrane of the coated stent 5 can be parallel to the membrane; the needle pushing mechanism 11 can be longitudinally slidably arranged on one side of the handle 1, and can drive the membrane rupturing needle 8 to pass through the needle outlet 205 along the cavity of the catheter 2; the guide wire, the distal end of which can enter the cavity of the catheter 2 from the end of the handle 1 and pass through the guide wire port; the membrane rupturing needle 8, the proximal end section of which is fixedly connected to the needle pushing mechanism 11, and the distal end of which can enter the cavity of the catheter 2 from the inside of the handle 1 shell 12 and pass through the needle outlet 205; its distal end is used for puncture. It is understandable that the needle outlet 205 and the guide wire outlet can be arranged opposite to each other or staggered longitudinally; compared with the prior art, in the catheter 2 that is mainly responsible for receiving and transporting the membrane-breaking needle 8 into the target blood vessel cavity, a guide wire outlet is added that is in a fixed position relationship with the needle outlet 205, so that the guide wire can become an auxiliary positioning component or a limiting component to limit / inhibit the circumferential torsion of the catheter 2 (sometimes it can also further limit / inhibit the longitudinal displacement of the catheter 2), which helps the stent graft 5 and the branch blood vessel to obtain mutually aligned stent graft 5 windows and branch blood vessel orifices through a single windowing operation; avoid multiple adjustments of the stent graft 5 after windowing to correct the stent graft 5 window so that it is aligned with the branch blood vessel orifice, avoid multiple operations and replacement of instruments, and save surgical time. The needle pushing mechanism 11 fixedly connected to the proximal end of the membrane-breaking needle 8 and arranged on the handle 1 is convenient for the operator to control the needle insertion stroke.

[0093] In some specific applications, the catheter 2 includes a guidewire cavity 201 and a needle cavity 202 spaced apart from each other; the guidewire inlet 10 is provided on the proximal surface of the catheter 2 and is connected to the guidewire cavity 201, and the membrane rupture needle inlet 206 is provided on the side wall of the proximal section of the catheter 2 and is connected to the needle cavity 202; the membrane rupture needle 8 enters from the membrane rupture needle inlet 206 and is passed through the needle cavity 202, the guidewire enters from the guidewire inlet 10 and is passed through the guidewire cavity 201, and the needle outlet 205 is connected to the distal end of the needle cavity 202, and the guidewire outlet is connected to the distal end of the guidewire cavity 201. It can be understood that improving the catheter 2 into a multi-lumen tube 2100, which is provided with independent cavities to respectively accommodate the guide wire and the membrane rupture needle 8, can effectively avoid entanglement and interference between the two; further, the entrances of the two are respectively arranged on the end face and the side wall of the catheter 2, so as to improve the convenience of the operator's operation, especially when the membrane rupture needle entrance 206 is arranged on the side wall of the catheter 2, which provides convenience for the introduction of the second guide wire 13 and avoids interference between the second guide wire 13 and the guide wire.

[0094] In some specific applications, the guidewire can enter the branch artery 4 , and the guidewire is used to circumferentially limit the catheter 2 ; and / or; the guidewire is used to longitudinally limit the catheter 2 .

[0095] In some specific applications, the inner wall of the connection between the needle cavity 202 and the needle outlet 205 is a smooth curved surface structure. Compared with the existing straight track push needle, the smooth curved surface structure can effectively avoid the problem that the needle is easy to change direction after the catheter 2 is twisted.

[0096] In some specific applications, a boss is fixedly provided on the inner wall of the needle cavity 202, and a slide groove is provided on the side wall of the membrane-breaking needle 8, and the slide groove can be slidably provided on the boss. When the membrane-breaking needle 8 penetrates the needle cavity 202, the slide groove can be slidably provided on the boss, so that the needle cavity 202 and the membrane-breaking needle 8 are limited, and when the catheter 2 rotates, the membrane-breaking needle 8 can rotate synchronously with it.

[0097] In some specific applications, the inner wall of the needle cavity 202 is provided with a smooth strip groove arranged along the length direction, and the side wall of the membrane-breaking needle 8 is provided with a smooth protrusion arranged along the length direction, and the protrusion can be slidably arranged in the strip groove. A boss is added to the catheter 2, and a groove is provided on the side wall of the membrane-breaking needle 8. The groove cooperates with the boss, so that the membrane-breaking needle 8 can rotate with the catheter 2 without deflection.

[0098] In some specific applications, the membrane rupture needle inlet 206 is far away from the guide wire inlet 10 and is disposed toward the distal end of the handle 1. The membrane rupture needle inlet 206 is an elongated opening extending longitudinally along the catheter 2. The guide wire inlet 10 is connected to the Luer connector. The membrane rupture needle inlet 206 is an elongated opening so that the proximal end section of the membrane rupture needle 8 fixedly connected to the needle pushing mechanism 11 can slide longitudinally along the catheter 2 outside the catheter 2 wall.

[0099] In some specific applications, the needle pushing mechanism 11 includes a three-way component 1103, which includes a tubular body 1101 and a manifold 1102; the tubular body 1101 is movably sleeved on the proximal end of the catheter 2 and is sealed and connected to the catheter 2; the proximal end of the membrane-breaking needle 8 is fixedly connected to the manifold 1102; the tubular body 1101 can cover the membrane-breaking needle inlet 206. The membrane-breaking needle 8, the catheter 2 and the guide wire are movably sealed and matched through the three-way component 1103, which effectively reduces blood leakage.

[0100] A membrane rupture device for a coated stent 5 comprises: a handle 1 having a longitudinally extending shell 12 for supporting a catheter 2 and a needle pushing mechanism 11; the catheter 2 having a distal end and a proximal end, the proximal end of which is fixed to the handle 1; the catheter 2 comprising a guidewire cavity 201 and a needle cavity 202 spaced apart from each other; a needle outlet 205 is provided on the side wall of the distal end of the catheter 2, and a guidewire port is provided on the side wall of the catheter 2 opposite to the needle outlet 205; the guidewire port is communicated with the guidewire cavity 201 and can face the branch artery 4; the needle outlet 205 is connected to the needle cavity 202 and can be parallel to the membrane of the coated stent 5; the needle pushing mechanism 11 can longitudinally It is slidably arranged on one side of the handle 1; the needle pushing mechanism 11 includes a three-way component 1103, and the three-way component 1103 includes a tubular body 1101 and a manifold 1102; the tubular body 1101 is movably sleeved on the proximal end section of the catheter 2 and is sealed with the catheter 2; a guide wire, the distal end of which can enter the cavity of the catheter 2 from the end of the handle 1 and pass out through the guide wire port; the guide wire is used to circumferentially limit the catheter 2; and, or the guide wire is used to longitudinally limit the catheter 2; a membrane rupturing needle 8, the proximal end of which is fixedly connected to the manifold 1102, and the distal end of which can enter the needle cavity 202 and pass out through the needle outlet 205; its distal end is used for puncture. Compared with the prior art, in the catheter 2 which is mainly responsible for receiving and delivering the membrane-breaking needle 8 into the target blood vessel cavity, a guide wire port is added which is in a fixed position relationship with the needle outlet 205, so that the guide wire can become an auxiliary positioning component or a limiting component to limit / inhibit the circumferential torsion of the catheter 2 (sometimes it can also further limit / inhibit the longitudinal displacement of the catheter 2), which helps the coated stent 5 and the branch blood vessel to obtain mutually aligned coated stent 5 windows and branch blood vessel orifices through a single windowing operation; avoid multiple adjustments of the coated stent 5 after windowing to correct the coated stent 5 window so that it is aligned with the branch blood vessel orifice, avoid multiple operations and replacement of instruments, and save surgical time. The membrane-breaking needle 8, the catheter 2 and the guide wire are movably sealed and matched by the three-way component 1103, which effectively reduces blood leakage; and provides convenience for the introduction of the second guide wire 13, avoiding the interference between the second guide wire 13 and the guide wire.

[0101] In some specific applications, the membrane rupturing needle 8 is a thin and long hollow tube with an inner cavity; the proximal end of the tube is connected to the manifold 1102 .

[0102] In some specific applications, a second guide wire 13 is also included, which enters the membrane-breaking needle lumen 830 through the manifold 1102 and passes through the distal end of the membrane-breaking needle 8. The second guide wire 13 can be captured by the capture device of the brachial artery access route and stretched out of the body, and a balloon, stent or other device can be introduced along the second guide wire 13.

[0103] In some specific applications, a smooth conical head 6 is fixedly provided at one end of the catheter 2 away from the handle 1; the material of the conical head 6 is a high molecular polymer. The conical head 6 is mainly used to prevent the distal end of the catheter 2 from damaging the blood vessel due to excessive hardness and to facilitate the distal end of the catheter 2 to be pushed into the target blood vessel cavity. The conical head 6 is also called a TIP head. The material of the conical head 6 is preferably silicone.

[0104] In some specific applications, the guidewire includes a spiral spring-shaped guidewire or stent 7 disposed near the guidewire port of the catheter 2. It is understandable that the spiral spring-shaped guidewire or stent 7 disposed at the distal end of the guidewire has a relatively small guidewire tip, which has a better effect of anchoring the guidewire in the branch vessel cavity, and also further inhibits the circumferential torsion and longitudinal slippage of the catheter 2.

[0105] In some specific applications, a longitudinally extending elongated through hole is provided on one side of the handle 1 shell 12, and a portion of the needle pushing mechanism 11 extends outward from the inside of the handle 1 through the elongated through hole and away from the shell 12; a scale mark 121 is provided longitudinally on one side of the elongated through hole; the longitudinal sliding stroke of the needle pushing mechanism 11 corresponds to the scale mark 121, so that the control of the needle removal stroke becomes more precise and adjustable, thereby controlling its puncture depth.

[0106] In some specific applications, the needle outlet 205 and the guide wire outlet on the distal end of the catheter 2 are arranged staggered in the longitudinal direction, or the needle outlet 205 and the guide wire outlet on the distal end of the catheter 2 are arranged flush in the longitudinal direction.

[0107] In some specific applications, the membrane-breaking needle 8 and the needle cavity 202 of the catheter 2 are limited by a specific structure, thereby avoiding the membrane-breaking needle 8 from being misplaced when the catheter 2 rotates; in one embodiment, the inner wall of the needle cavity 202 is fixedly provided with a boss of a smooth strip structure arranged along the length direction, and the side wall of the membrane-breaking needle 8 is provided with a long strip-shaped slide groove. When the membrane-breaking needle 8 penetrates the needle cavity 202, the slide groove can be slidably arranged on the boss, so that the needle cavity 202 and the membrane-breaking needle 8 are limited, and when the catheter 2 rotates, the membrane-breaking needle 8 can follow the synchronous rotation. In another embodiment, in order to improve the strength of the membrane-breaking needle 8, a smooth strip groove arranged along the length direction is provided on the inner wall of the needle cavity 202, and a smooth protrusion arranged along the length direction is provided on the side wall of the membrane-breaking needle 8. The protrusion can be slidably arranged in the strip groove, which can also achieve the limiting effect of the membrane-breaking needle 8 and the catheter 2. At the same time, because the side wall of the membrane-breaking needle 8 is a protruding structure instead of a groove, the overall strength of the membrane-breaking needle 8 is greater.

[0108] In some specific applications, the catheter 2 of the aforementioned stent graft 5 membrane rupture device and the stent graft 5 membrane rupture device are both multi-lumen tubes 2100, and the multi-lumen tubes 2100 are provided with a bending stiffness balancing cavity 203 to improve its torsion control performance.

[0109] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only used to help understand the method and core ideas of the present invention. At the same time, for those skilled in the art, according to the ideas of the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A stent graft membrane rupture device, characterized in that: include: The catheter comprises a first unit and a second unit connected in sequence from a proximal end to a distal end; The material hardness of the second unit is greater than the material hardness of the first unit; The catheter is provided with a continuous elongated guidewire cavity and a needle cavity between the first unit and the second unit; the guidewire cavity and the needle cavity are arranged at intervals; a guidewire outlet communicating with the guidewire cavity is provided on the side wall of the second unit, and a needle outlet communicating with the needle cavity is provided on the side wall of the second unit opposite to the guidewire outlet; The second unit needle cavity is provided with an arc-shaped guide rail; The guidewire can be slidably placed in the guidewire cavity; after the distal end of the guidewire enters the hollow anatomical structure from the guidewire cavity through the guidewire outlet, the guidewire can inhibit the circumferential torsion of the catheter; the guidewire is used as an auxiliary positioning or limiting component, and cooperates with the side wall of the distal end section of the catheter with relatively high hardness; The membrane-breaking needle can be slidably placed in the needle cavity; the distal end of the membrane-breaking needle has a needle blade, and the membrane-breaking needle body near the needle blade includes an arc-shaped pre-bent portion; the arc-shaped pre-bent portion is arranged in cooperation with the arc-shaped guide rail; The first state of the stent graft membrane rupture device is that the guidewire pushes out the catheter and anchors it in the lumen of the branch blood vessel; the stent graft membrane rupture device also includes a second state, and the second state is that the membrane rupture needle pushes out the catheter to open a window on the stent graft in the first state of the stent graft membrane rupture device; the guidewire, the catheter and the membrane rupture needle are basically in the same plane or straight line.

2. The stent graft membrane rupture device according to claim 1, characterized in that: The distal end section of the guidewire includes a first guidewire section and a second guidewire section which are connected in sequence; the first guidewire section is the tip of the guidewire and is softer than the second guidewire section.

3. The membrane rupture device of the stent graft according to claim 2, characterized in that: The stent graft membrane rupture device has a first state; In the first state, the distal end of the second guidewire segment slides away from the catheter through the guidewire outlet, and the proximal end of the second guidewire segment remains in the guidewire cavity.

4. A stent graft membrane rupture device, characterized in that: include: The catheter comprises a first unit and a second unit connected in sequence from the proximal end to the distal end; The material hardness of the second unit is greater than the material hardness of the first unit; The catheter is provided with a continuous elongated guidewire cavity and a needle cavity between the first unit and the second unit; the guidewire cavity and the needle cavity are arranged at intervals; a guidewire outlet communicating with the guidewire cavity is provided on the side wall of the second unit, and a needle outlet communicating with the needle cavity is provided on the side wall of the second unit opposite to the guidewire outlet; the needle cavity of the second unit is provided with an arc guide rail; The guidewire can be slidably placed in the guidewire cavity; the distal end section of the guidewire includes a first guidewire section and a second guidewire section connected in sequence; the first guidewire section is the tip of the guidewire and is softer than the second guidewire section; the guidewire is used as an auxiliary positioning or limiting member and cooperates with the side wall of the distal end section of the catheter with relatively high hardness; The membrane-breaking needle can be slidably placed in the needle cavity; the distal end of the membrane-breaking needle has a needle blade, and the membrane-breaking needle body near the needle blade includes an arc-shaped pre-bent portion; the arc-shaped pre-bent portion is arranged in cooperation with the arc-shaped guide rail; The first state of the stent graft membrane rupture device is that the guidewire pushes out the catheter and anchors it in the lumen of the branch blood vessel; the stent graft membrane rupture device also includes a second state, and the second state is that the membrane rupture needle pushes out the catheter to open a window on the stent graft in the first state of the stent graft membrane rupture device; the guidewire, the catheter and the membrane rupture needle are basically in the same plane or straight line.

5. The stent graft membrane rupture device according to claim 1 or 4, characterized in that: The membrane rupturing needle has a hollow inner cavity that penetrates the distal and proximal ends; the arc-shaped pre-bent portion includes staggered slits.

6. The stent graft membrane rupture device according to claim 5, characterized in that: It also includes a second guide wire that is inserted into the inner cavity of the membrane rupturing needle.

7. The stent graft membrane rupture device according to claim 5, characterized in that: The cutting edge of the membrane rupturing needle blade faces the proximal end or the distal end of the catheter.

8. The stent graft membrane rupture device according to claim 1 or 4, characterized in that: The arc-shaped guide rail comprises a slide groove block close to the distal end of the catheter; the slide groove block is used to resist the force exerted by the membrane rupture needle on the arc-shaped guide rail toward the distal end of the catheter.

9. The stent graft membrane rupture device according to claim 1 or 4, characterized in that: The first unit is a polymer material, and the second unit is a metal material.

10. The stent graft membrane rupture device according to claim 1 or 4, characterized in that: The catheter also includes a third unit connected to the distal end of the second unit. The third unit is in a frustum shape. The material hardness of the third unit is less than that of the first unit.

11. The stent graft membrane rupture device according to claim 10, characterized in that: The proximal section where the third unit is connected to the second unit comprises a guide groove continuous with the guide wire cavity; the guide groove is recessed toward the center of the catheter; and the guide groove is used for guiding the guide wire into the hollow anatomical structure.

12. The stent graft membrane rupture device according to claim 10, characterized in that: The third unit also includes a developing member having a direction indication.

13. The stent graft membrane rupture device according to claim 1 or 4, characterized in that: The needle outlet is oval or teardrop-shaped.

14. The stent graft membrane rupture device according to claim 1 or 4, characterized in that: The cross section of the catheter is a circular, elliptical or regular polygonal shape; the catheter also includes a bending stiffness balancing cavity located between the guidewire cavity and the needle cavity; the bending stiffness balancing cavity is used to balance the axial bending stiffness of the entire catheter.

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