A membrane rupture device for a covered stent

Abstract

The present invention discloses a stent graft membrane rupture device, which relates to the field of medical device technology, including a handle, a longitudinally extending shell, and is used to support a catheter and a needle-pushing mechanism; the proximal end section of the catheter is fixed to the handle, and a cavity is provided inside the handle that passes through the proximal end and extends toward the distal end; a needle outlet is provided on the side wall of the distal end section of the catheter, and a guidewire outlet is provided on the side wall of the catheter opposite to the needle outlet, the guidewire outlet can face the branch artery, and the needle outlet can be parallel to the membrane of the stent graft; the needle-pushing mechanism can be longitudinally slidably arranged on one side of the handle; the distal end of the guidewire can enter the cavity of the catheter from the end of the handle and pass out through the guidewire outlet; the proximal end section of the membrane rupture needle is fixedly connected to the needle-pushing mechanism, and its distal end can enter the cavity of the catheter from the inside of the handle shell and pass out through the needle outlet; its distal end is used for puncture. The present invention adds a guidewire outlet that is in a fixed position relationship with the needle outlet, so that the guidewire can become an auxiliary positioning component and has an auxiliary positioning function.

Description

Technical Field

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

[0002] With the continuous development of endovascular revascularization surgery, the application of covered stents has also increased. However, the use of covered stents in some special areas, such as the aortic arch, celiac trunk, bilateral renal arteries and superior mesenteric artery, will affect the blood supply to the arterial branches, which greatly limits the use of covered stents in these areas. Currently, stent surgery in these areas can only be performed through improved surgical procedures, such as hybrid surgery, or through improved instruments, such as modular stents, pre-fenestrated stents, branch stents, multi-layer bare stents and other new device technologies. However, in the vast majority of cases, the anatomical structure of the aortic arch lesion is extremely complex, and there are significant individual differences. The above technical solutions are strongly dependent on the anatomical structure of the human body's branch vessels, which poses a huge challenge to their product standardization and commercialization.

[0003] In situ fenestration of a covered stent is a more advanced technology, encompassing two main categories: energy fenestration and mechanical fenestration. Energy fenestration uses energy sources such as lasers, radiofrequency, and thermocouples to create the desired pores by ablating the covered stent. However, this method places high demands on the equipment. If the energy is too high, the stent coating will carbonize, and its decomposition products may trigger thrombosis; if the energy is insufficient, the desired fenestration effect will not be achieved. Furthermore, energy can not only ablate the stent coating but also potentially damage surrounding tissue. Therefore, mechanical fenestration has become a relatively conservative, but safer, method of fenestration.

[0004] In the existing technology, a mechanical stent in situ fenestration technology is to puncture the stent coating with a hollow membrane-piercing needle with a guide wire, then withdraw the membrane-piercing needle and use a cutting balloon to enter the coated stent along the guide wire for expansion. The problem with this method is that the needle cannot accurately find the central position of the branch vessel opening, and it is easy to deviate or damage the surrounding blood vessels in a dynamic blood vessel. The needle and needle tube used are an integrated structure with poor flexibility. The rigid needle tube is not suitable for curved blood vessels; the puncture drive is inconvenient, resulting in insufficient puncture force.

[0005] Another mechanical stent in situ fenestration technology is to coat the end of the stent with an ultra-hard guidewire, and then use 1mm, 3mm, and 8mm expansion balloons to gradually expand the opening position. The problem with this method is that guidewire puncture is only applicable to polyester coated stents, not e-PTFE coated stents. The guidewire cannot accurately find the central position of the branch vessel opening, and it is easy to deviate or damage the surrounding blood vessels in a dynamic blood vessel. After the hard end of the guidewire is punctured, it is difficult to find the puncture point again during the guidewire exchange process. After the guidewire puncture, its pore size is small, and it cannot be expanded at one time with a large balloon. It must be gradually expanded with the help of small balloons, which increases the time of the operation and the cost of the equipment.

[0006] Another method for in situ fenestration of a mechanical stent involves using an anchoring balloon fixed to the branch vessel. The puncture needle, pushed by the puncture needle shaft, punctures the stent graft. The puncture site is then expanded using a dilator, and a guidewire is then inserted to achieve in situ fenestration. This technical solution improves needle positioning somewhat by using the anchoring balloon. However, the anchoring balloon is relatively soft and easily deforms in complex, tortuous vessels, making it difficult to ensure the puncture point is centered in the branch vessel, posing a risk of misalignment. This technology utilizes a coaxial structure, which makes the inner and outer tubes susceptible to relative displacement. During insertion, the balloon is prone to deformation. If squeezed together, this increases insertion resistance, and excessive stretching can lead to rupture. The puncture needle tube is not sealed, making it impossible to confirm successful puncture by creating a shadow solution with the puncture needle. Furthermore, the puncture needle shaft is prone to flexing, potentially puncturing other instruments or surrounding tissue. Furthermore, the puncture depth cannot be precisely adjusted to meet the needs, which can result in excessive puncture depth, potentially injuring contralateral tissue, or insufficient puncture depth, leading to unsuccessful puncture.

[0007] In summary, there is an urgent need for a membrane breaker structure with an auxiliary positioning function. Summary of the Invention

[0008] 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. By adding a guide wire port in a fixed position relationship with the needle outlet, the guide wire can become an auxiliary positioning component and have an auxiliary positioning function.

[0009] To achieve the above object, the present invention provides the following solutions:

[0010] The present invention provides a stent graft membrane rupture device, comprising:

[0011] a handle having a longitudinally extending housing for supporting the catheter and the needle pushing mechanism;

[0012] The catheter has a distal end and a proximal end, wherein the proximal end is fixed to the handle and has a cavity therein that passes through the proximal end and extends toward the distal end. A needle exit port is formed on a side wall of the distal end of the catheter, and a guide wire port is formed on a side wall of the catheter opposite the needle exit port. The guide wire port can face the branch artery, and the needle exit port can be parallel to the membrane of the coated stent.

[0013] A needle pushing mechanism is longitudinally slidably disposed on one side of the handle, and is capable of driving the membrane rupture needle to pass through the needle outlet along the cavity of the catheter;

[0014] A guide wire, the distal end of which can enter the lumen of the catheter from the end of the handle and exit through the guide wire port;

[0015] The membrane rupture needle has a proximal end fixedly connected to the needle pushing mechanism, and a distal end capable of entering the cavity of the catheter from the inside of the handle shell and exiting through the needle outlet; the distal end is used for puncture.

[0016] Optionally, the catheter includes a guidewire cavity and a needle cavity spaced apart from each other; the guidewire inlet is provided on the proximal surface of the catheter and is connected to the guidewire cavity, and the membrane-breaking needle inlet is provided on the side wall of the proximal section of the catheter and is connected to the needle cavity; the membrane-breaking needle enters from the membrane-breaking needle inlet and is passed through the needle cavity, the guidewire enters from the guidewire inlet and is passed through the guidewire cavity, and the needle outlet is connected to the distal end of the needle cavity, and the guidewire outlet is connected to the distal end of the guidewire cavity.

[0017] Optionally, the guidewire can enter the branch artery, and the guidewire is used to circumferentially limit the catheter; and / or; the guidewire is used to longitudinally limit the catheter.

[0018] Optionally, the inner wall of the connection point between the needle cavity and the needle outlet is a smooth curved surface structure.

[0019] Optionally, a boss is fixedly provided on the inner wall of the needle cavity, and a sliding groove is provided on the side wall of the membrane-breaking needle, and the sliding groove can be slidably provided on the boss.

[0020] Optionally, the inner wall of the needle cavity is provided with a smooth strip groove arranged along the length direction, and the side wall of the membrane-breaking needle is provided with a smooth protrusion arranged along the length direction, and the protrusion can be slidably arranged in the strip groove.

[0021] Optionally, the membrane rupture needle inlet is away from the guide wire inlet and arranged toward the distal end of the handle, and the membrane rupture needle inlet is an elongated opening extending longitudinally along the catheter; the guide wire inlet is connected to the Luer connector.

[0022] Optionally, the needle pushing mechanism includes a three-way component, which includes a tubular body and a manifold; the tubular body is movably mounted on the proximal end of the catheter and is sealed with the catheter; the proximal end of the membrane rupture needle is fixed to the manifold; the tubular body can cover the entrance of the membrane rupture needle.

[0023] The present invention provides a stent graft membrane rupture device, comprising:

[0024] a handle having a longitudinally extending housing for supporting the catheter and the needle pushing mechanism;

[0025] The catheter has a distal end and a proximal end, wherein the proximal end is fixed to the handle; the catheter includes a guidewire cavity and a needle cavity spaced apart from each other; a needle outlet is formed on a side wall of the distal end of the catheter, and a guidewire port is formed on a side wall of the catheter opposite to the needle outlet; the guidewire port is connected to the guidewire cavity and can face the branch artery; the needle outlet and the needle cavity can be parallel to the membrane of the stent graft;

[0026] The needle pushing mechanism is longitudinally slidably disposed on one side of the handle; the needle pushing mechanism includes a three-way component, which includes a tubular body and a manifold; the tubular body is movably sleeved on the proximal end of the catheter and is sealed to the catheter;

[0027] A guidewire, the distal end of which can enter the lumen of the catheter from the end of the handle and exit through the guidewire port; the guidewire is used to limit the circumferential position of the catheter; and, or the guidewire is used to limit the longitudinal position of the catheter;

[0028] The membrane rupture needle has a proximal end fixedly connected to the manifold, and a distal end capable of entering the needle cavity and exiting through the needle outlet; the distal end is used for puncture.

[0029] Optionally, the membrane rupturing needle is a thin and long hollow tube with an inner cavity; the proximal end of the tube is connected to the manifold.

[0030] Optionally, a second guide wire is also included, which enters the inner cavity of the membrane rupture needle through the manifold and exits from the distal end of the membrane rupture needle.

[0031] Optionally, a smooth conical head is fixedly provided at one end of the catheter away from the handle; the conical head is made of a high molecular polymer.

[0032] Optionally, the guidewire includes a coil spring-shaped guidewire or stent arranged near the guidewire port of the catheter.

[0033] Optionally, a longitudinally extending elongated through hole is provided on one side of the handle shell, and a part of the push-pin mechanism extends outward from the inside of the handle through the elongated through hole and away from the shell; a scale mark is provided along the longitudinal direction on one side of the elongated through hole; the longitudinal sliding stroke of the push-pin mechanism corresponds to the scale mark.

[0034] Optionally, the needle outlet and the guide wire outlet on the distal end section of the catheter are arranged staggered in the longitudinal direction, or the needle outlet and the guide wire outlet on the distal end section of the catheter are arranged flush in the longitudinal direction.

[0035] Compared with the prior art, the present invention has achieved the following technical effects:

[0036] The present invention adds a guide wire port in a fixed position relationship with the needle outlet to the catheter which is mainly responsible for receiving and delivering the membrane rupture needle into the target blood vessel lumen, so that the guide wire can become an auxiliary positioning component or a limiting component to limit / inhibit the circumferential torsion of the catheter (sometimes it can further limit / inhibit the longitudinal displacement of the catheter). This helps the stent graft and the branch blood vessel to obtain mutually aligned stent graft windows and branch blood vessel orifices through a single windowing operation; avoids multiple adjustments to the stent graft after windowing to correct the stent graft window so that it is aligned with the branch blood vessel orifice, avoids multiple operations and replacement of instruments, and saves surgical time. The membrane rupture needle, catheter and guide wire are movably sealed and connected through a three-way component, which effectively reduces blood leakage; and provides convenience for the introduction of the second guide wire, avoiding interference between the second guide wire and the guide wire. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. 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 any creative work.

[0038] Figure 1 A schematic longitudinal cross-sectional view of a multi-lumen tube for an interventional device according to the present invention;

[0039] Figure 2 A schematic cross-sectional view of a multi-lumen tube for an interventional device according to the present invention;

[0040] Figure 3 Schematic diagram of the partial structure of the membrane rupture device of the covered stent in some embodiments of the present invention;

[0041] Figure 4 Schematic diagram of the partial structure of the membrane rupture device of the covered stent in some embodiments of the present invention;

[0042] Figure 5 A schematic diagram of the cross-sectional structure of the first unit of the membrane rupture device for the stent graft in some embodiments of the present invention;

[0043] Figure 6 In some embodiments of the present invention, the stent graft membrane rupture device Figure 5 AA cross-sectional structural diagram;

[0044] Figure 7 In some embodiments of the present invention, the stent graft membrane rupture device Figure 5 BB cross-sectional structure diagram;

[0045] Figure 8 A schematic diagram of the longitudinal cross-sectional structure of the second unit of the membrane rupture device for the stent graft in some embodiments of the present invention;

[0046] Figure 9 Schematic diagram of the three-dimensional structure of the guidewire outlet in some embodiments of the present invention;

[0047] Figure 10 Schematic diagram of the three-dimensional structure of the needle outlet in some embodiments of the present invention;

[0048] Figure 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;

[0049] Figure 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;

[0050] Figure 13 Schematic diagram of the membrane rupture needle structure in some embodiments of the present invention;

[0051] Figure 14 Schematic diagram of the membrane rupture needle structure in some embodiments of the present invention;

[0052] Figure 15 Schematic diagram of a guidewire structure having a first guidewire segment and a second guidewire segment in some embodiments of the present invention;

[0053] Figure 16 Schematic diagram of the three-dimensional structure of the membrane rupture device of the covered stent in some embodiments of the present invention;

[0054] Figure 17 A top view of a membrane rupture device for a stent graft in some embodiments of the present invention;

[0055] Figure 18 for Figure 17 AA cross-sectional diagram;

[0056] Figure 19 for Figure 17 BB cross-sectional diagram;

[0057] Figure 20 This is a cross-sectional schematic diagram of a stent graft membrane rupture device with the handle shell removed in some embodiments of the present invention;

[0058] Figure 21 Schematic cross-sectional view of a tee component in some embodiments of the present invention;

[0059] Figure 22 Schematic diagram of the longitudinal sliding fit between the proximal end of the membrane rupture needle and the membrane rupture needle inlet at the proximal end of the catheter in some embodiments of the present invention;

[0060] Figure 23 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;

[0061] Figure 24A partial schematic diagram of a stent graft membrane rupture device with a second guide wire in some embodiments of the present invention;

[0062] Figure 25 A stent graft membrane rupture device with scale markings in some embodiments of the present invention;

[0063] Figure 26 This is a schematic diagram of a stent graft membrane rupture device in use according to the present invention;

[0064] Figure 27 This is a schematic diagram of a stent graft membrane rupture device in use according to the present invention;

[0065] Figure 28 This is a schematic diagram of a stent graft membrane rupture device in use.

[0066] In the figure: 1-handle, 10-guidewire inlet, 11-needle pushing mechanism, 12-housing, 121-scale mark, 1101-tubular body, 1102-manifold, 1103-tee 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-shaped guide rail, 222-slide block, 231-guide groove, 232-developing component, 3-aorta, 4-branched artery, 5-covered stent, 6-conical head, 7-coil spring-shaped guide wire or stent, 8-membrane rupture needle, 810-needle blade, 811-blade, 812-slit, 820-arc-shaped 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

[0067] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 making creative efforts are within the scope of protection of the present invention.

[0068] The term "longitudinal" in the embodiments of the present invention refers to the direction of a catheter, multi-lumen tube, or handle having a length value, extending from the proximal end to the distal end, or from the distal end to the proximal end, when not subject to external forces. "Transverse" refers to the direction perpendicular to the longitudinal direction. "Cross-section" refers to the transverse cross-section of a catheter, multi-lumen tube, or handle. "Proximal" refers to the end closest to the operator outside the body; "distal" refers to the end away from the operator outside the body.

[0069] 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 object. "Flexural rigidity of section" is also called cross-sectional bending stiffness. "Torsion control" is also called controllability: 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 toward the target direction in the lesion or to align the side wall components with the target when manipulating the proximal end of the catheter.

[0070] After extensive and in-depth research, the applicant discovered that the uneven arrangement of the lumens within a multi-lumen tube results in varying bending stiffness in all directions perpendicular to the tube's axis, further contributing to variations in the tube's overall torsion control performance and reducing its overall torsion control. Through finite element calculations and rearrangement of the lumens, including the addition of side lumens, the applicant balanced the multi-lumen tube's bending stiffness in all directions (circumferential or longitudinal, or circumferential and longitudinal), thereby improving its torsion control performance. The applicant also found in specific applications (such as stent graft 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 the side of the lumen; 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 rotation 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 force and bending of the multi-lumen tube in all directions is made as equal 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 facilitates membrane rupture. Generally, the additional auxiliary cavities are not used to introduce, accommodate or transport related instruments and fluids.

[0071] 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:

[0072] like Figure 1 and Figure 2 As shown, a catheter assembly for interventional instruments includes a slender multi-lumen tube 2100 with two ends, the cross section 2200 of the multi-lumen tube 2100 is a circle, an ellipse, or a regular polygon; 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, etc. One of the multi-lumen tube, fluid, stent, embolic spring coil, and balloon catheter; the second cavity section 2220 extends from the proximal end of the multi-lumen tube 2100 to the distal end of the multi-lumen 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 embolic spring coil, and a balloon catheter; the third cavity section 2230 extends from the proximal end of the multi-lumen tube 2100 to the distal end of the multi-lumen tube 2100 to form a third cavity 2130, and the third cavity 2130 is used to balance the axial bending stiffness of the multi-lumen 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.

[0073] 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.

[0074] Furthermore, the third cavity cross section 2230 is a circle, an ellipse, or a regular polygon.

[0075] 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; and 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.

[0076] Furthermore, the centers of the two third cavity sections 2230 are arranged on the same diameter of the multi-lumen tube 2100; the diameter of the multi-lumen tube 2100 where the center of the third cavity section 2230 is located is perpendicular to the diameter of the multi-lumen tube 2100 where the center of the first cavity section 2210 is located.

[0077] Furthermore, the multi-lumen tube body 2300 near the distal end does not have the third cavity 2130 ; the first cavity 2110 passes through both end surfaces of the multi-lumen tube body 2300 .

[0078] Furthermore, the second cavity 2120 near the distal end of the multi-lumen tube body 2300 penetrates the side wall of the multi-lumen tube 2100 to form a side through hole communicating with the outside.

[0079] 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 of the cross section 2200 of the multi-lumen tube 2100 ranges from 0.5 mm to 10 mm.

[0080] 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 of the multi-lumen tube 2100 .

[0081] In some specific applications, the above-mentioned catheter 2 or catheter assembly with the bending stiffness balancing cavity 203 is used in a membrane rupture device of the 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.

[0082] For in situ fenestration of the stent graft 5, existing technologies include: acupuncture antegrade in situ fenestration technology (developed by German Tilo in 2013). Reported by a French hospital in 2018, N=16), a transseptal needle is used for puncture during EVAR; a bare stent is pre-placed to assist in laser in situ fenestration technology (reported by a French hospital in 2018, N=16), that is, a bare stent is implanted in the target vessel for auxiliary positioning; some surgeons also pre-place a guidewire in the branch vessel and use a long sheath to assist in puncture.

[0083] After extensive and in-depth research, the applicant discovered that antegrade in situ fenestration (i.e., puncturing the window with a puncture needle from the inside of the stent cavity to the outside) has many shortcomings: high positioning requirements; many anatomical limitations: the angle between the branch vessel and the aorta 3 affects the feasibility of in situ fenestration; easy puncture of the 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-placed guidewires in the branch vessels and assisted by a long sheath for puncture, the long sheath has insufficient positioning ability. After the long sheath is in place and the main stent is released, its distal end has a certain probability of deviating from the branch opening, resulting in the window not being able to align with the branch artery 4 (in in vitro simulation tests 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 rupture device; 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 vascular anatomical structure (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).

[0084] 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, torque control performance, safety, and efficiency); based on this, the present invention provides a stent graft 5 membrane rupture device:

[0085] like Figures 3 to 8As shown, a membrane rupture device for a coated stent 5 includes: a catheter 2, the catheter 2 including 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 between the first unit 21 and the second unit 22; the guidewire cavity 201 and the needle cavity 202 are arranged at intervals; a guidewire outlet 204 is provided on the side wall of the second unit 22 and is connected to the guidewire cavity 201, and a guidewire outlet 204 is provided on the second unit 22 opposite to the guidewire outlet 204. A needle outlet 205 communicating with 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; the 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 conjunction with the arc-shaped guide rail 221. It can be understood that, compared with the existing technology, 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 coated stent 5 window 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 coated stent 5 window so that it is aligned with the branch blood vessel orifice, avoids multiple operations and instrument replacements, 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 twisting 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, catheter 2 and 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 avoid the membrane rupture device from becoming complicated due to the addition of the auxiliary positioning function, and avoid the catheter 2 responsible for delivering the membrane rupture needle 8 from being forced to increase the cross-section 2200 outer diameter due to excessive lumen space occupation (in other words, the original catheter 2 responsible for delivering the membrane rupture needle 8 does not need to increase the cross-section 2200 outer diameter too much to achieve the auxiliary positioning function). Compared with the existing straight track needle push-out, the arc pre-bent portion 820 of the membrane rupture needle 8 and the arc guide rail 221 of the catheter 2 are arranged in cooperation to 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.

[0086] In some specific applications, such as Figures 9 to 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 is understood that a soft guidewire tip is easier to enter the lumen of the branch vessel, but a soft guidewire body is not conducive to preventing the catheter 2 from twisting circumferentially.

[0087] 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 lumen 201. It is understandable that the guidewire and the membrane rupture needle 8 can be separately or simultaneously housed in the catheter 2 and delivered to the target blood vessel lumen; the guidewire can be pushed out of the guidewire outlet 204 before the membrane rupture needle 8 and enter the branch vessel, or it can be pushed out of the guidewire outlet 204 after the membrane rupture needle 8 and enter the branch vessel. The former is better than 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 / limit / inhibit 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.

[0088] In some specific applications, a membrane rupture device for a coated stent 5 includes: a catheter 2 including 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 continuous elongated 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 communicating with 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 second unit 22 needle cavity 202 is provided with an arc guide rail 221; the guide wire can be slidably placed in the guide wire cavity 201; the distal end 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 rupture needle 8 can be slidably placed in the needle cavity 202; the distal end of the membrane rupture needle 8 has a needle blade portion 810, and the membrane rupture 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 conjunction with the arc guide rail 221. It is understandable that the guidewire and the membrane-breaking needle 8 can be separately or simultaneously housed in the catheter 2 and delivered to the target blood vessel lumen; the guidewire can be pushed out of the guidewire outlet 204 into the branch vessel before the membrane-breaking needle 8, or it can be pushed out of the guidewire outlet 204 into the branch vessel after the membrane-breaking needle 8. 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 circumferential torsion of the catheter 2). The arcuate pre-bend portion 820 is arranged in conjunction with the arcuate guide rail 221, and it can be understood that the curvature radius of the arcuate pre-bend portion 820 is similar or close to the curvature radius of the arcuate guide rail 221.

[0089] In some specific applications, the membrane rupture needle 8 has a hollow inner cavity (the membrane rupture needle inner cavity 830) that runs through both ends; the arc-shaped pre-bent portion 820 includes staggered slits 812. A membrane rupture needle 8 with excellent overall performance is often also beneficial to the efficiency of the membrane rupture device. The structural design of the membrane rupture needle 8 body often requires comprehensive consideration of many aspects: the hypotube membrane rupture needle 8 is easier to bend; the arc-shaped pre-bent portion 820 of the nickel-titanium hypotube is easy to break after cutting; the arc-shaped pre-bent portion 820 of the stainless steel hypotube is not easy to bend; the combined nickel-titanium tube, one section of the membrane rupture needle 8 is used for puncture, and one section of ordinary tubing.

[0090] In some specific applications, a second guide wire 13 is also included that passes 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.

[0091] In some specific applications, the cutting edge 811 of the blade 810 of the membrane-breaking needle 8 is directed toward the proximal or distal end of the catheter 2. It is understood that when the distal end of the second guidewire 13 is directed toward the proximal end of the stent graft 5, the cutting edge 811 of the blade 810 of the membrane-breaking needle 8 is directed toward the proximal end of the catheter 2 to prevent the cutting edge 811 from damaging the second guidewire 13; when the distal end of the second guidewire 13 is directed toward the distal end of the stent graft 5, the cutting edge 811 of the blade 810 of the membrane-breaking needle 8 is directed toward the distal end of the catheter 2 to prevent the cutting edge 811 from damaging the second guidewire 13. The second guidewire 13 can be captured and pulled out of the body by the capture device of the brachial artery access, and a balloon, stent, or other device can be introduced along the second guidewire 13.

[0092] 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 rupture needle 8 on the arcuate guide rail 221 toward the distal end of the catheter 2 .

[0093] In some specific applications, the first unit 21 is made of a polymer material, and the second unit 22 is made of a metal material. It is understood that the first unit 21 is the main body of the proximal end of the catheter 2, primarily used to accommodate or transport the membrane-breaking needle 8 and the guidewire, and is also the main body of the torque control operation; the second unit 22 is the main body of the distal end of the catheter 2, primarily used to guide the removal of the membrane-breaking needle 8. Its sidewalls must cooperate with the guidewire to inhibit the circumferential torsion of the catheter 2. These functions require 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, as well as to resist the deformation caused by the interaction between the sidewalls and the guidewire when the catheter 2 is torsioned.

[0094] 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 frustum-shaped and made of a material with a lower hardness than the first unit 21. This unit is primarily used to prevent the distal end of the catheter 2 from damaging blood vessels due to excessive stiffness and to facilitate insertion of the distal end of the catheter 2 into the target vessel lumen. The third unit 23 is also called a TIP tip. The preferred material for the third unit 23 is silicone.

[0095] In some specific applications, the proximal end of the third unit 23, connected to the second unit 22, includes a guide groove 231 that is continuous with the guidewire lumen 201. The guide groove 231 is recessed toward the center of the catheter 2 and is used to guide the guidewire into hollow anatomical structures. Built-in imaging points are included to determine orientation (K, C, Z, etc.). A side-perforated tip facilitates smooth positioning of the guidewire within the target vessel.

[0096] In some specific applications, the third unit 23 further includes a developing member 232 having a direction indicator.

[0097] 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 pass through the needle outlet 205 smoothly.

[0098] In some specific applications, the cross-section 2200 of the catheter 2 is circular, elliptical, or a regular polygon. The catheter 2 also 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 understood that the addition of the bending stiffness balancing cavity 203 to the catheter 2 of the stent graft 5 rupture device improves the torsion controllability of the stent graft 5 rupture device, as previously described with respect to the torsion controllability of the multi-lumen tube 2100.

[0099] Another object of the present invention is to provide a stent graft 5 membrane rupture device design with excellent comprehensive performance (combining convenient operator operation, auxiliary positioning function, high efficiency, and simple structure); based on this, the present invention provides a stent graft 5 membrane rupture device:

[0100] like Figures 16 to 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 is fixed to the handle 1 and has a cavity therein 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 of the catheter 2; a guide wire port is provided on the side wall of the catheter 2 opposite to the needle outlet 205, and the guide wire port can face the branch artery 4, and the needle outlet 205 can The membrane of the stent graft 5 can be parallel to the membrane of the stent graft 5; 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 outlet; the membrane rupturing needle 8, the proximal end 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 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 lumen, a guide wire outlet is added that is fixed in position 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 further limit / inhibit the longitudinal displacement of the catheter 2). This helps the stent graft 5 and the branch vessel to obtain mutually aligned stent graft 5 windows and branch vessel orifices through a single windowing operation; it avoids multiple adjustments to the stent graft 5 after windowing to correct the stent graft 5 window so that it is aligned with the branch vessel orifice, avoids multiple operations and instrument changes, and saves surgical time. The needle pushing mechanism 11 fixed to the proximal end of the membrane-breaking needle 8 and arranged on the handle 1 facilitates the operator to control the needle insertion stroke.

[0101] 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 lumens 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 set on the end face and side wall of the catheter 2, thereby improving the convenience of the operator's operation, especially when the membrane rupture needle entrance 206 is set 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.

[0102] 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 .

[0103] 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 needle pushing and ejecting method, the smooth curved surface structure can effectively avoid the problem of the needle easily changing direction after the catheter 2 is twisted.

[0104] 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 rupture needle 8. The slide groove can slide on the boss when the membrane rupture needle 8 is inserted into the needle cavity 202, thereby limiting the position of the needle cavity 202 and the membrane rupture needle 8. When the catheter 2 rotates, the membrane rupture needle 8 can rotate synchronously with it.

[0105] 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 rupture needle 8 is provided with a smooth protrusion arranged along the length direction, which 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 rupture needle 8. The groove cooperates with the boss so that the membrane rupture needle 8 can rotate with the catheter 2 without deflection.

[0106] In some specific applications, the membrane puncture needle inlet 206 is located away from the guidewire inlet 10 and toward the distal end of the handle 1. The membrane puncture needle inlet 206 is an elongated opening extending longitudinally along the catheter 2; the guidewire inlet 10 is connected to the Luer connector. The elongated opening of the membrane puncture needle inlet 206 allows the proximal end of the membrane puncture needle 8, which is fixed to the needle pushing mechanism 11, to slide longitudinally along the catheter 2 outside the catheter wall.

[0107] In some specific applications, needle pushing mechanism 11 includes a three-way component 1103, which includes a tubular body 1101 and a manifold 1102. Tubular body 1101 is movably mounted on the proximal end of catheter 2 and is sealed therewith. The proximal end of membrane rupture needle 8 is fixedly connected to manifold 1102. Tubular body 1101 can cover membrane rupture needle inlet 206. The three-way component 1103 movably and sealably connects membrane rupture needle 8, catheter 2, and guidewire, effectively reducing blood leakage.

[0108] A membrane rupture device for a coated stent 5 comprises: a handle 1 having a longitudinally extending housing 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 further limit / inhibit the longitudinal displacement of the catheter 2). This helps the stent graft 5 and the branch blood vessel to obtain mutually aligned windows of the stent graft 5 and the branch blood vessel orifice through a single windowing operation; it avoids adjusting the stent graft 5 multiple times after windowing to correct the stent graft 5 window so that it is aligned with the branch blood vessel orifice, avoids multiple operations and replacement of instruments, and saves surgical time. The membrane-breaking needle 8, the catheter 2 and the guide wire are movably sealed and connected by the three-way component 1103, which effectively reduces blood leakage; and provides convenience for the introduction of the second guide wire 13, avoiding interference between the second guide wire 13 and the guide wire.

[0109] In some specific applications, the membrane rupturing needle 8 is a thin and long hollow tube with an inner lumen; the proximal end of the tube is in communication with the manifold 1102 .

[0110] In some specific applications, a second guidewire 13 is also included. The second guidewire 13 enters the membrane-breaking needle lumen 830 through the manifold 1102 and exits from the distal end of the membrane-breaking needle 8. The second guidewire 13 can be captured by a capture device for brachial artery access and pulled out of the body. A balloon, stent, or other device can then be introduced along the second guidewire 13.

[0111] In some specific applications, a smooth tapered tip 6 is fixed to the end of the catheter 2 distal to the handle 1. This tip 6 is made of a polymer. This tip 6 is primarily used to prevent the rigid distal end of the catheter 2 from damaging blood vessels and to facilitate insertion of the distal end of the catheter 2 into the target vessel lumen. This tip 6 is also called a TIP tip. Silicone is preferred.

[0112] In some specific applications, the guidewire includes a coil spring-shaped guidewire or stent 7 disposed near the guidewire port of the catheter 2. It is understood that the coil 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 lumen and further inhibiting circumferential torsion and longitudinal slippage of the catheter 2.

[0113] 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 ejection stroke becomes more precise and adjustable, thereby controlling its puncture depth.

[0114] 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.

[0115] In some specific applications, the membrane rupture needle 8 and the needle cavity 202 of the catheter 2 are limited by a specific structure, thereby preventing the membrane rupture needle 8 from being misaligned when the catheter 2 rotates. In one embodiment, the inner wall of the needle cavity 202 is fixed with a smooth strip-shaped boss arranged along the length direction, and the side wall of the membrane rupture needle 8 is provided with a long strip-shaped slide groove. During the process of the membrane rupture needle 8 entering the needle cavity 202, the slide groove can slide on the boss, thereby limiting the needle cavity 202 and the membrane rupture needle 8. When the catheter 2 rotates, the membrane rupture needle 8 can rotate synchronously. In another embodiment, to improve the strength of the membrane rupture needle 8, a smooth strip groove is provided on the inner wall of the needle cavity 202 along the length direction, and a smooth protrusion is provided on the side wall of the membrane rupture needle 8 along the length direction. The protrusion can slide within the strip groove, which can also achieve the function of limiting the membrane rupture needle 8 and the catheter 2. At the same time, because the side wall of the membrane rupture needle 8 is a protrusion structure instead of a groove, the overall strength of the membrane rupture needle 8 is greater.

[0116] In some specific applications, the aforementioned membrane rupture device of the stent graft 5 and the catheter 2 of the membrane rupture device of the stent graft 5 are both multi-lumen tubes 2100, and the multi-lumen tube 2100 is provided with a bending stiffness balancing cavity 203 to improve its torsion control performance.

[0117] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.

Claims

1. A membrane rupture device for a stent graft, characterized in that: include: a handle having a longitudinally extending housing for supporting the catheter and the needle pushing mechanism; The catheter has a distal end and a proximal end, and includes a first unit and a second unit connected in sequence from the proximal end to the distal end; the second unit is made of a material having a greater hardness than the first unit; The proximal end of the catheter is fixed to the handle, and a cavity is formed inside the handle, which passes through the proximal end and extends toward the distal end. A needle outlet is formed on the side wall of the distal end of the catheter, and a guide wire outlet is formed on the side wall of the catheter opposite to the needle outlet. The guide wire outlet can face the branch artery, and the needle outlet can be parallel to the membrane of the stent graft. A needle pushing mechanism is longitudinally slidably disposed on one side of the handle, and is capable of driving the membrane rupture needle to pass through the needle outlet along the cavity of the catheter; A guide wire, the distal end of which can enter the lumen of the catheter from the end of the handle and exit through the guide wire port; the guide wire is used to assist in positioning or limiting the member and cooperates with the relatively hard side wall of the distal end of the catheter; The membrane rupture needle has a proximal end fixedly connected to the needle pushing mechanism, and a distal end capable of entering the cavity of the catheter from the inside of the handle housing and exiting through the needle outlet; the distal end is used for puncture; The first state of the stent graft membrane breaker is that the guidewire pushes out the catheter and anchors it in the lumen of the branch blood vessel; the stent graft membrane breaker also includes a second state, in which the membrane breaker needle pushes out the catheter to open a window on the stent graft in the first state of the stent graft membrane breaker; the guidewire, catheter and membrane breaker 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 catheter includes a guidewire cavity and a needle cavity spaced apart from each other; the guidewire inlet is provided on the proximal surface of the catheter and communicates with the guidewire cavity, and the membrane-breaking needle inlet is provided on the side wall of the proximal section of the catheter and communicates with the needle cavity; the membrane-breaking needle enters through the membrane-breaking needle inlet and passes through the needle cavity, the guidewire enters through the guidewire inlet and passes through the guidewire cavity, and the needle outlet is communicated with the distal end of the needle cavity, and the guidewire inlet is communicated with the distal end of the guidewire cavity.

3. The membrane rupture device for the stent graft according to claim 1, characterized in that: The guide wire is used to longitudinally limit the catheter.

4. The membrane rupture device for the stent graft according to claim 2, characterized in that: The inner wall of the connection point between the needle cavity and the needle outlet is a smooth curved surface structure.

5. The membrane rupture device for the stent graft according to claim 2, characterized in that: A boss is fixedly provided on the inner wall of the needle cavity, and a sliding groove is provided on the side wall of the membrane-breaking needle. The sliding groove can be slidably arranged on the boss.

6. The membrane rupture device for the stent graft according to claim 2, characterized in that: The inner wall of the needle cavity is provided with a smooth strip groove arranged along the length direction, and the side wall of the membrane-breaking needle is provided with a smooth protrusion arranged along the length direction, and the protrusion can be slidably arranged in the strip groove.

7. The membrane rupture device for the stent graft according to claim 2, characterized in that: The membrane rupture needle inlet is away from the guide wire inlet and is arranged toward the distal end of the handle. The membrane rupture needle inlet is an elongated opening extending longitudinally along the catheter. The guide wire inlet is connected to the Luer connector.

8. The stent graft membrane rupture device according to claim 7, characterized in that: The needle pushing mechanism includes a three-way component, which includes a tubular body and a manifold; the tubular body is movably sleeved on the proximal end of the catheter and is sealed with the catheter; the proximal end of the membrane rupture needle is fixed to the manifold; the tubular body can cover the entrance of the membrane rupture needle.

9. A membrane rupture device for a stent graft, characterized in that: include: a handle having a longitudinally extending housing for supporting the catheter and the needle pushing mechanism; The catheter has a distal end and a proximal end, and includes a first unit and a second unit connected in sequence from the proximal end to the distal end; the second unit is made of a material having a greater hardness than the first unit; Its proximal end is fixed to the handle; the catheter includes a guidewire cavity and a needle cavity spaced apart from each other; a needle outlet is provided on the side wall of the distal end of the catheter, and a guidewire port is provided on the side wall of the catheter opposite to the needle outlet; the guidewire port is connected to the guidewire cavity and can face the branch artery; the needle outlet and the needle cavity can be parallel to the membrane of the stent graft; The needle pushing mechanism is longitudinally slidably disposed on one side of the handle; the needle pushing mechanism includes a three-way component, which includes a tubular body and a manifold; the tubular body is movably sleeved on the proximal end of the catheter and is sealed to the catheter; A guidewire, the distal end of which can enter the lumen of the catheter from the end of the handle and exit through the guidewire port; the guidewire is used to limit the circumferential position of the catheter; and, or the guidewire is used to limit the longitudinal position of the catheter; and cooperates with the relatively hard side wall of the distal end section of the catheter; a membrane rupture needle, the proximal end of which is fixedly connected to the manifold, and the distal end of which is capable of entering the needle cavity and exiting through the needle outlet; the distal end of which is used for puncture; The first state of the stent graft membrane breaker is that the guidewire pushes out the catheter and anchors it in the lumen of the branch blood vessel; the stent graft membrane breaker also includes a second state, in which the membrane breaker needle pushes out the catheter to open a window on the stent graft in the first state of the stent graft membrane breaker; the guidewire, catheter and membrane breaker needle are basically in the same plane or straight line.

10. The stent graft membrane rupture device according to claim 9, characterized in that: The membrane rupture needle is a slender hollow tube with an inner lumen; Its proximal end is in communication with the manifold.

11. The stent graft membrane rupture device according to claim 10, characterized in that: The device also includes a second guide wire, which enters the inner cavity of the membrane rupture needle through the manifold and exits from the distal end of the membrane rupture needle.

12. The stent graft membrane rupture device according to claim 1 or 9, characterized in that: A smooth conical head is fixedly provided at one end of the catheter away from the handle; the conical head is made of high molecular polymer.

13. The stent graft membrane rupture device according to claim 1 or 9, characterized in that: The guide wire comprises a spiral spring-shaped guide wire or a stent arranged near the guide wire port of the catheter.

14. The stent graft membrane rupture device according to claim 1 or 9, characterized in that: A longitudinally extending elongated through hole is provided on one side of the handle shell, and a part of the push-pin mechanism extends outward from the inside of the handle through the elongated through hole and away from the shell; a scale mark is provided along the longitudinal direction on one side of the elongated through hole; the longitudinal sliding stroke of the push-pin mechanism corresponds to the scale mark.

15. The stent graft membrane rupture device according to claim 1 or 9, characterized in that: The needle outlet and the guide wire outlet on the distal end of the catheter are arranged in a staggered manner in the longitudinal direction, or the needle outlet and the guide wire outlet on the distal end of the catheter are arranged in a flush manner in the longitudinal direction.

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