Aortic covered stent in-situ fenestration puncture and membrane rupture set

Abstract

The present invention provides an in-situ fenestration puncture and membrane rupture set for an aortic covered stent, which relates to the field of medical devices and includes a puncture and membrane rupture assembly, a membrane dilation assembly, and a support outer tube assembly; it includes a core wire, a dilation tube, and a support and guide tube which are sleeved from the inside to the outside; multiple expansion wires that radially expand outward in an ellipsoidal shape in a free state are provided at a position of the dilation tube close to the distal end; multiple long slits are provided at a position of the support and guide tube close to the distal end; the dilation tube and the support and guide tube can axially slide and / or circumferentially rotate so that when they are in a first relative position, the multiple expansion wires are constrained inside the support and guide tube by the tube wall of the support and guide tube, and when they are in a second relative position, the multiple expansion wires respectively bulge out of the support and guide tube from the multiple long slits. The present invention can be applied in in-situ fenestration surgery to quickly rupture the membrane after accurately positioning the fenestration and membrane rupture point of the aortic covered stent and quickly expand the opening after membrane rupture.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to an in-situ fenestration puncture and membrane rupture set for an aortic covered stent. Background Art

[0002] The stent treatment of aortic aneurysm is characterized by small trauma and quick recovery, and is particularly suitable for patients with extremely high risks of previous open surgeries. The covered stent is implanted into the aneurysm, and the normal arteries at the proximal and distal ends of the aneurysm are connected through the covered stent, so that the arterial blood flow no longer fills into the aneurysm body, and the aortic aneurysm body will gradually thrombose, thereby playing a role in isolating the aortic aneurysm.

[0003] Since there are many important branch vessels in the aorta, such as the subclavian artery, celiac trunk, renal artery, mesenteric artery, etc., these branch vessels supply blood to important organs of the body. Therefore, when some aortic aneurysms involve these important branch vessels, we cannot directly isolate the aortic aneurysm with a covered stent, because this will cover these important branch vessels at the same time, resulting in insufficient blood supply to important organs. Thus, the aortic aneurysm stent fenestration technique has emerged, that is, the covering film at the position corresponding to the opening of each branch vessel on the covered stent is removed to form a window to ensure the normal blood supply of the important branch vessels after the covered stent is implanted. This technique mainly includes two types: pre-fenestration and in-situ fenestration. The pre-fenestration technique is to combine medical imaging equipment to perform angiography imaging on the lesion site of the patient before implanting the covered stent, calculate the precise position of the important branch vessels on the covered stent, remove the covering film on this part of the covered stent to form a window, and then implant the fenestrated covered stent into the patient's artery; the in-situ fenestration technique is to first implant a covered stent into the patient's artery, and then perform fenestration on the side of the covered stent through the branch vessel. Due to the differences in the lesion location, blood vessel size, and branch vessel opening site of aortic aneurysm patients, the in-situ fenestration technique is preferably used.

[0004] For a more specific surgical method of the in-situ fenestration technique, in the prior art, generally, medical imaging equipment is used to perform angiography imaging on the lesion site. Under the guidance of the imaging equipment, medical staff locate the opening site of the branch vessel on the surface of the aortic covered stent, introduce a sheath from the femoral artery or brachial artery into the sheath to the aorta, send a guiding catheter with different tip angles along the sheath, align the tip of the catheter with the branch opening angle, send a guide wire along the guiding catheter to pierce the covering film at the position where the aortic covered stent needs to be fenestrated, then withdraw the guiding catheter, and then lower a balloon catheter for membrane dilation along the guide wire for dilation treatment, so as to complete the in-situ fenestration.

[0005] However, the guide wire used in the traditional in-situ fenestration and membrane puncture method is a conventional guide wire, which has problems such as inaccurate distal position due to insufficient or excessive softness of the guide wire, resulting in ineffective support or weak support point force of the guide wire in the guiding catheter, and the problem that the distal end of the guide wire is not easy to pierce the covered membrane due to inappropriate dimensions such as too thick or too thin of the guide wire. These problems lead to potential safety hazards such as complex surgical operations and long surgical times.

[0006] In addition, since the opening of the membrane puncture point is much smaller than the distal end of the balloon catheter, when the balloon enters along the guide wire after membrane puncture, the distal end of the balloon will be stuck and unable to pass when it contacts the covered membrane. To solve this problem, the current response method of doctors is to shape the distal end of the balloon catheter by cutting, squeezing, etc. and then insert it. However, such an operation has the risk that the catheter tip affects the fluidity of the catheter inside the blood vessel, is prone to damage the blood vessel or introduce foreign bodies to cause thrombosis. In addition, the on-site shaping operation also prolongs the surgical operation time and increases the surgical safety hazards. Summary of the Invention

[0007] The purpose of the present invention is to provide an in-situ fenestration and puncture membrane set for an aortic covered stent to alleviate the above technical problems.

[0008] To achieve the above purpose, the embodiments of the present invention adopt the following technical solutions:

[0009] The embodiments of the present invention provide an in-situ fenestration and puncture membrane set for an aortic covered stent, including a puncture membrane assembly, a membrane expansion assembly, and a support outer tube assembly;

[0010] The puncture membrane assembly includes a core wire;

[0011] The membrane expansion assembly includes an expansion tube axially slidably sleeved outside the core wire; a plurality of expansion wires are arranged at intervals in the circumferential direction of the expansion tube near the distal end, and the length direction extends along the axial direction of the expansion tube. In the free state, the plurality of expansion wires expand radially outward along the expansion tube to form an ellipsoidal shape;

[0012] The support outer tube assembly includes a support guide tube sleeved outside the expansion tube. A plurality of long slits are arranged at intervals in the circumferential direction of the support guide tube near the distal end, and the length direction extends along the axial direction of the support guide tube;

[0013] Axial sliding and / or circumferential rotation can occur between the expansion tube and the support guide tube, so that when the two are in the first relative position, the plurality of expansion wires are constrained inside the support guide tube by the tube wall of the support guide tube, and when the two are in the second relative position, the plurality of expansion wires bulge out of the support guide tube from the plurality of long slits respectively.

[0014] In an alternative embodiment, the support and guiding tube includes a proximal straight guiding tube section and a distal arc-shaped guiding tube section pre-bent into a circular arc shape, and the long slit is provided at the distal part of the proximal straight guiding tube section.

[0015] In an alternative embodiment, if the arc length of the distal arc-shaped guiding tube section is L and the angle between the tangent line at the distal end point of the distal arc-shaped guiding tube section and the extension line of the distal side of the proximal straight guiding tube section is α, then: 15 mm ≤ L ≤ 20 mm, 20° ≤ α ≤ 40°.

[0016] In an alternative embodiment, spiral tube slits arranged in a helical pattern along the circumferential direction of the dilatation tube are further provided on the circumferential wall of the dilatation tube.

[0017] In an alternative embodiment, the puncture and membrane-breaking assembly further includes a coiled spring tube, the coiled spring tube is sleeved outside the distal section of the core wire, and the distal end of the coiled spring tube is fixedly connected to the distal end of the core wire, the proximal end of the coiled spring tube is fixedly connected to the outer peripheral surface of the core wire, and the coiled spring tube includes a large-diameter section, a tapered gradual change section with a diameter gradually decreasing from the proximal end to the distal end, and a small-diameter section connected in sequence from the proximal end to the distal end.

[0018] In an alternative embodiment, coiled spring imaging parts are respectively provided at the distal end of the large-diameter section, the distal end of the tapered gradual change section, and the distal end of the small-diameter section of the coiled spring tube.

[0019] In an alternative embodiment, in the support and guiding tube, guiding tube imaging parts are respectively provided at the proximal end point of the distal arc-shaped guiding tube section and the distal end point of the whole support and guiding tube;

[0020] and / or, axial scale lines are provided on the outer peripheral surface of the dilatation tube;

[0021] and / or, axial scale lines are provided on the outer peripheral surface of the core wire.

[0022] In an alternative embodiment, the dilatation tube and the support and guiding tube are axially relatively positioned and can rotate relative to each other circumferentially;

[0023] The support outer tube assembly further includes an outer tube handle, the proximal end of the support and guiding tube is detachably fixed in an axial through hole provided inside the outer tube handle, and a first clamping structure is provided at the proximal end of the outer tube handle;

[0024] The membrane dilatation assembly further includes a dilatation tube handle, the proximal end of the dilatation tube is detachably fixed in an axial through hole provided inside the dilatation tube handle, the dilatation tube handle is located on the proximal side of the outer tube handle, and a second clamping structure is provided at the distal end of the dilatation tube handle;

[0025] The proximal end of the outer tube handle is inserted and sleeved with the distal end of the dilatation tube handle. At least one of the first clamping structure and the second clamping structure is a circumferential groove, and the other is a protrusion rotatably fitted inside the circumferential groove, so that the dilatation tube handle and the outer tube handle can rotate relative to each other circumferentially, thereby driving the support outer tube and the dilatation tube to rotate relative to each other, and further enabling the support outer tube and the dilatation tube to be switched between the first relative position and the second relative position.

[0026] In an alternative embodiment, the support guide tube includes a tube body and a guide tube end member connected to the proximal end of the tube body. An inner hole communicating with the lumen of the tube body is provided inside the guide tube end member.

[0027] The outer tube handle includes a first tube seat member, a second tube seat member, an end cap and a tube seat seal member, each of which is internally provided with an axial through hole.

[0028] The axial through hole of the first tube seat member is a first stepped hole with a larger proximal aperture than the distal aperture. A first positioning portion is provided on the proximal hole wall of the first stepped hole. The axial through hole of the end cap is a second stepped hole with a smaller proximal aperture than the distal aperture. A second positioning portion is provided on the distal hole wall of the second stepped hole. A proximal positioning portion and a distal positioning portion are respectively provided on the outer peripheral walls at both axial ends of the second tube seat member. The inner diameter of the axial through hole of the tube seat seal member is configured to be able to pass through the core wire and have an interference fit with the core wire.

[0029] The tube body passes through the first stepped hole, and the guide tube end member is blocked on the proximal side of the stepped surface of the first stepped hole. The distal end of the second tube seat member is inserted into the proximal hole of the first stepped hole, and the distal positioning portion and the first positioning portion are in concave-convex fit. The distal end face of the second tube seat member abuts against the proximal end face of the guide tube end member. The tube seat seal member is arranged inside the first stepped hole and is blocked on the distal side of the stepped surface of the first stepped hole. The proximal end of the second tube seat member is inserted into the distal part of the second stepped hole, and the proximal positioning portion and the second positioning portion are in concave-convex fit. The distal end face of the tube seat seal member abuts against the proximal end face of the second tube seat member.

[0030] The first clamping structure is provided at the proximal end of the end cap.

[0031] In an alternative embodiment, the dilatation tube handle includes a distal handle fitting, a proximal handle fitting and a handle seal member, each of which is internally provided with an axial through hole.

[0032] The proximal end of the dilatation tube is inserted into and interference-fitted with the axial through hole of the handle seal member.

[0033] The axial through hole of the distal handle fitting is a stepped hole with a proximal aperture larger than the distal aperture. The handle seal is disposed inside the proximal hole of the axial through hole of the distal handle fitting and is blocked on the proximal side of the stepped surface of the axial through hole of the distal handle fitting.

[0034] The distal end of the proximal handle fitting is inserted into and threadedly connected to the inside of the proximal hole of the axial through hole of the distal handle fitting, and the distal end surface of the proximal handle fitting abuts against the proximal end surface of the handle seal.

[0035] The second clamping structure is disposed at the distal end of the distal handle fitting.

[0036] In particular, in the embodiments of the present invention, "and / or" means that among the first feature before "and / or" and the second feature after "and / or", the following specific setting manners are included: (1) only the first feature is provided, and the second feature is not provided; (2) only the second feature is provided, and the first feature is not provided; (3) the first feature and the second feature are provided simultaneously.

[0037] This embodiment can at least achieve the following beneficial effects:

[0038] Applying the aortic covered stent puncture and membrane rupture set provided in this embodiment to the in-situ fenestration procedure, during membrane rupture, the core wire is supported and guided by the support guide tube of the support outer tube assembly to improve the accurate positioning of the membrane rupture point. After membrane rupture, the dilation tube of the dilation assembly quickly expands the opening of the membrane rupture point without the need to additionally insert a balloon catheter for dilation. The operation process is simpler and the surgery is more efficient. More importantly, the dilation tube and the support guide tube can axially slide and / or circumferentially rotate, so that when they are in the first relative position, multiple expansion wires are constrained inside the support guide tube by the tube wall of the support guide tube, and when they are in the second relative position, multiple expansion wires of the dilation tube bulge out of the support guide tube from multiple long slits of the support guide tube. Combining the fourth and fifth steps of the surgical procedure, multiple expansion wires of the dilation tube can easily enter and exit the opening of the membrane rupture point under the constraint of the support guide tube without jamming, the dilation process is smoother, and the operation risk during the surgery is effectively reduced. Description of the Drawings

[0039] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0040] Figure 1Schematic diagram of the overall structure of the puncture and membrane rupture assembly in the in-situ fenestration puncture and membrane rupture set of the aortic covered stent provided by the embodiment of the present invention;

[0041] Figure 2 For Figure 1 Local enlarged view of the middle and distal regions;

[0042] Figure 3 For Figure 1 Local enlarged view of the middle and proximal regions;

[0043] Figure 4 For Figure 3 Explosion schematic diagram of the structure shown;

[0044] Figure 5 Schematic diagram of the overall structure of the membrane expansion assembly in the in-situ fenestration puncture and membrane rupture set of the aortic covered stent provided by the embodiment of the present invention;

[0045] Figure 6 For Figure 5 Explosion structure schematic diagram;

[0046] Figure 7 For Figure 6 Local enlarged view of the middle and distal regions;

[0047] Figure 8 For Figure 6 Local enlarged view of the middle and proximal regions;

[0048] Figure 9 For Figure 5 Schematic diagram of the state where the expansion wires in the distal region of the expansion tube are radially constrained in the membrane expansion assembly shown;

[0049] Figure 10 Fracture view of the overall structure of the puncture and membrane rupture assembly in the in-situ fenestration puncture and membrane rupture set of the aortic covered stent provided by the embodiment of the present invention;

[0050] Figure 11 For Figure 10 Local structural schematic diagram of the distal region of the puncture and membrane rupture assembly;

[0051] Figure 12 Schematic diagram of the usage steps of the in-situ fenestration puncture and membrane rupture set of the aortic covered stent provided by the embodiment of the present invention Figure 1 ;

[0052] Figure 13 Schematic diagram of the usage steps of the in-situ fenestration puncture and membrane rupture set of the aortic covered stent provided by the embodiment of the present invention Figure 2 ;

[0053] Figure 14Schematic diagram of the usage steps of the in-situ fenestration puncture and membrane rupture set of the aortic covered stent provided by the embodiment of the present invention Figure 3 ;

[0054] Figure 15 It is a schematic diagram of the distal contact part when the support outer tube assembly contacts the membrane of the aortic covered stent when using the in-situ fenestration puncture and membrane rupture set of the aortic covered stent provided by the embodiment of the present invention.

[0055] Icons: 100 - puncture and membrane rupture assembly; 1 - core wire; 2 - coiled spring tube; 21 - large diameter section; 22 - tapered transition section; 23 - small diameter section; 24 - coiled spring imaging part;

[0056] 200 - membrane expansion assembly; 3 - expansion tube; 31 - expansion wire; 32 - spiral tube seam; 4 - expansion tube handle; 401 - second clamping structure; 41 - distal handle fitting; 42 - proximal handle fitting; 43 - handle seal;

[0057] 300 - support outer tube assembly; 5 - support guide tube; 501 - guide tube end component; 51 - proximal straight guide tube section; 511 - long slit; 52 - distal arc guide tube section; 53 - guide tube imaging part; 6 - outer tube handle; 601 - first clamping structure; 61 - tube seat part one; 611 - first stepped hole; 6110 - first positioning part; 62 - tube seat part two; 621 - proximal positioning part; 622 - distal positioning part; 63 - end cover; 631 - second stepped hole; 6310 - second positioning part; 64 - tube seat seal;

[0058] 400 - aortic covered stent. Detailed implementation manners

[0059] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. Usually, the components of the embodiments of the present invention described and illustrated herein can be arranged and designed in various different configurations.

[0060] Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed present invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0061] It should be noted that: similar reference numerals and letters denote similar items in the drawings. Therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0062] In the description of the present invention, it should be noted that:

[0063] Unless otherwise clearly specified and defined, the terms "arrangement", "installation", and "connection" shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be directly connected, or indirectly connected through an intermediate medium, and may be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

[0064] The orientation or positional relationship indicated by terms such as "proximal end", "distal end", "front end", "rear end", "axial direction", "radial direction", "circumferential direction", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the invention product is usually placed during use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the indicated device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention.

[0065] The terms "first", "second", etc. are only used for distinguishing descriptions, do not represent the total number, or the relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0066] Hereinafter, taking the end of the medical device close to the operator during surgery as the proximal end of the medical device, and the end of the medical device entering the patient's blood vessel as the distal end of the medical device (that is, the front end of the medical device is the distal end, and the rear end of the medical device is the proximal end), some embodiments of the present invention will be described in detail with reference to the drawings.

[0067] Refer to Figures 1 to 15 , this embodiment provides an in-situ fenestration puncture and membrane rupture set for an aortic covered stent, and the set includes a puncture and membrane rupture assembly 100, a membrane dilation assembly 200, and a support outer tube assembly 300.

[0068] Among them: The puncture and membrane rupture assembly 100 includes a core wire 1. The membrane dilation assembly 200 includes a dilation tube 3 axially slidably sleeved outside the core wire 1; a plurality of expansion wires 31 are arranged at intervals in the circumferential direction of the dilation tube 3 at a position close to the distal end of the dilation tube 3, and the length direction extends along the axial direction of the dilation tube 3. In the free state, the plurality of expansion wires 31 expand radially outward along the dilation tube 3 to form an ellipsoidal shape, and the expansion wires 31 can be selected but are not limited to being cut from the dilation tube 3. The support outer tube assembly 300 includes a support guide tube 5 sleeved outside the dilation tube 3, and a plurality of long slits 511 are arranged at intervals in the circumferential direction of the support guide tube 5 at a position close to the distal end of the support guide tube 5, and the length direction extends along the axial direction of the support guide tube 5.

[0069] The expansion tube 3 can axially slide and / or circumferentially rotate relative to the support and guide tube 5, such that when the two are in a first relative position, multiple expansion wires 31 are constrained inside the support and guide tube 5 by the tube wall of the support and guide tube 5, and when the two are in a second relative position, the multiple expansion wires 31 of the expansion tube 3 bulge out of the support and guide tube 5 from multiple elongated slits 511 of the support and guide tube 5 respectively.

[0070] During use, the surgical operation steps refer to Figures 12 to 15 :

[0071] First step: Under percutaneous puncture, insert a guide wire into the branch vessel of the aorta where in-situ fenestration is to be performed until the lesion site.

[0072] Second step: Along the guide wire, insert the combination of the membrane expansion assembly 200 and the support outer tube assembly 300 provided by the present invention, such that the distal end face of the support and guide tube 5 in the support outer tube assembly 300 is completely attached to the membrane of the pre-fenestration area on the side of the aortic covered stent 400.

[0073] Third step: Axially penetrate the core wire 1 of the puncture and membrane rupture assembly 100 through the expansion tube 3 of the membrane expansion assembly 200, and push the puncture and membrane rupture assembly 100 forward (distally) relative to the support outer tube assembly 300, such that the distal end of the support outer tube assembly 300 advances forward to penetrate the membrane of the aortic covered stent 400.

[0074] Fourth step: Push the puncture and membrane rupture assembly 100, the membrane expansion assembly 200, and the support outer tube assembly 300 forward (they can be pushed simultaneously or separately, and during the process, ensure that the expansion tube 3 and the support and guide tube 5 are always in the first relative position), or push the membrane expansion assembly 200 and the support outer tube assembly 300 forward along the puncture and membrane rupture assembly 100 (they can be pushed simultaneously or separately, and during the process, ensure that the expansion tube 3 and the support and guide tube 5 are always in the first relative position), until the elongated slits 511 of the support and guide tube 5 enter the holes penetrated in the membrane of the aortic covered stent 400.

[0075] Fifth step: Actuate the membrane expansion assembly 200 relative to the support outer tube assembly 300, such that the support and guide tube 5 moves relative to the expansion tube 3 until the expansion tube 3 and the support and guide tube 5 are in the second relative position, and the multiple expansion wires 31 of the expansion tube 3 bulge out of the support and guide tube 5 from multiple elongated slits 511 of the support and guide tube 5 respectively. Then, circumferentially rotate the support outer tube assembly 300 and the membrane expansion assembly 200 relative to the core wire 1 of the puncture and membrane rupture assembly 100, such that the multiple expansion wires 31 with an ellipsoidal outer contour after bulging circumferentially rotate to expand the holes penetrated in the membrane of the aortic covered stent 400.

[0076] Step 6: After the reaming is completed, move the membrane expanding assembly 200 relative to the support outer tube assembly 300 so that the support guide tube 5 moves relative to the expansion tube 3 until the expansion tube 3 and the support guide tube 5 are in the first relative position. Then, withdraw the support outer tube assembly 300 and the membrane expanding assembly 200 backward (proximally) along the puncture and membrane breaking assembly 100, and retain the core wire 1 of the puncture and membrane breaking assembly 100 as a guide wire to insert other subsequent instruments for subsequent surgical operations.

[0077] Apply the aortic covered stent 400 puncture and membrane breaking set provided in this embodiment in the in-situ fenestration procedure. During membrane breaking, the core wire 1 is supported and guided for positioning by the support guide tube 5 of the support outer tube assembly 300, which improves the accurate positioning of the membrane breaking point. After membrane breaking, the expansion tube 3 of the membrane expanding assembly 200 quickly expands the opening of the membrane breaking point without the need to additionally insert a balloon catheter for expansion. The operation process is simpler and the surgery is more efficient. More importantly, the expansion tube 3 and the support guide tube 5 can axially slide and / or circumferentially rotate so that when they are in the first relative position, multiple expansion wires 31 of the expansion tube 3 are constrained inside the support guide tube 5 by the tube wall of the support guide tube 5, and when they are in the second relative position, multiple expansion wires 31 of the expansion tube 3 bulge out of the support guide tube 5 from multiple long slits 511 of the support guide tube 5 respectively. Combining the fourth and fifth surgical steps, multiple expansion wires 31 of the expansion tube 3 can easily enter and exit the opening of the membrane breaking point under the constraint of the support guide tube 5 without jamming, the expansion process is smoother, and the operation risk during surgery is effectively reduced.

[0078] In an alternative embodiment of this example, to further improve the smoothness of the support guide tube 5 and the expansion tube 3 inside it entering and exiting the opening of the membrane breaking point during the expansion process, refer to Figure 10 and Figure 11, the puncture membrane rupture assembly 100 further includes a coiled tube 2. The coiled tube 2 is sleeved outside the distal segment of the core wire 1, and the distal end of the coiled tube 2 is fixedly connected to the distal end of the core wire 1. The proximal end of the coiled tube 2 is fixedly connected to the outer peripheral surface of the core wire 1. The coiled tube 2 includes a large-diameter segment 21, a tapered gradual change segment 22 with a diameter gradually decreasing from the proximal end to the distal end, and a small-diameter segment 23 that are sequentially connected from the proximal end to the distal end. In the third step of the surgical operation procedure, when puncturing the membrane of the aortic covered stent 400, the end point at the distal end of the small-diameter segment 23 of the coiled tube 2 is used as the puncture end for puncturing. Guided by the tapered gradual change segment 22 of the coiled tube 2, the large-diameter segment 21 of the coiled tube 2 performs a first pre-expansion opening on the punctured membrane rupture point opening, which is more beneficial for the fourth to sixth steps. The multiple expansion wires 31 of the expansion tube 3 respectively bulge out of the multiple long openings 511 of the support guiding tube 5 outside the support guiding tube 5 to perform a secondary expansion opening on the membrane rupture point opening, and the support guiding tube 5 and the expansion tube 3 inside it can smoothly enter and exit the membrane rupture point opening when the two are in the first relative position. Optionally, to adapt to the overall shape of the coiled tube 2, the distal segment of the core wire 1 is designed into a tapered structure similar to the coiled tube 2. For ease of manufacturing, the proximal end of the large-diameter segment 21 of the coiled tube 2 can but is not limited to be provided with a connecting sleeve, and the connecting sleeve is sleeved and fixedly connected to the outer peripheral wall of the core wire 1.

[0079] In this alternative embodiment, to further facilitate the operation of the operator, optionally, coiled tube imaging parts 24 are respectively provided at the distal end of the large-diameter segment 21, the distal end of the tapered gradual change segment 22, and the distal end of the small-diameter segment 23 of the coiled tube 2 for the operator to clearly view the position of the coiled tube 2 with the assistance of imaging equipment. Among them, the coiled tube imaging parts 24 can be made of radiopaque metal materials such as platinum, iridium, tantalum, gold, and stainless steel, and the shape can be annular, semi-circular, or any other shape, and can be fixed to the junction of each pipe segment of the core wire 1 or the coiled tube 2 by forging or bonding.

[0080] In the alternative embodiment of this example, to further increase the accuracy of positioning the membrane rupture point position on the aortic covered stent 400, referring to Figure 1 and Figure 2 , the support guiding tube 5 includes a proximal straight guiding tube segment 51 and a distal arc guiding tube segment 52 pre-bent into a circular arc shape, and the long opening 511 is provided at the distal part of the proximal straight guiding tube segment 51. Referring to Figure 15 , when the aortic covered stent 400 is implanted in the aortic arch blood vessel, the arc design of the distal arc guiding tube segment 52 is more beneficial for making the distal end face of the support guiding tube 5 fit the membrane of the aortic covered stent 400, and then guiding the distal end of the core wire 1 to puncture perpendicular to the membrane of the aortic covered stent 400, so as to avoid various subsequent adverse problems caused by the deviation of the fenestration position on the aortic covered stent 400.

[0081] In this alternative embodiment, preferably but not limited to, in the support guide tube 5, if the arc length of the distal arc-shaped guide tube section 52 is L, and the angle between the tangent line at the distal end point of the distal arc-shaped guide tube section 52 and the extended line of the distal side of the proximal straight guide tube section 51 is α, then: 15 mm ≤ L ≤ 20 mm, 20° ≤ α ≤ 40°. For example but not limited to, L is 15 mm or 20 mm or any length between 15 mm and 20 mm, and α is 20° or 40° or any angle between 20° and 40°. The ranges of the arc length and the angle are adapted to the vascular dimensions of the aortic arch region of most patients, which is more conducive to ensuring that the distal end of the above-mentioned guiding core wire 1 punctures along the film of the aortic covered stent 400 perpendicularly.

[0082] In addition, when multiple layers of catheters are stacked, the tube layer structure has a greater hardness during the delivery process, which will increase the operation difficulty for the operator. In this regard, in the alternative embodiment of this embodiment, spiral tube slits 32 arranged spirally along the circumferential direction of the dilation tube 3 are further provided on the peripheral wall of the dilation tube 3, thereby reducing the hardness of the dilation tube 3 and enhancing the flexibility of the tube layer structure during delivery.

[0083] To facilitate the operator to accurately control the delivery positions of the support guide tube 5 and the dilation tube 3 inside the blood vessel, in the alternative embodiment of this embodiment, guide tube imaging parts 53 are respectively provided at the proximal end point of the distal arc-shaped guide tube section 52 of the support guide tube 5 and the distal end point of the entire support guide tube 5. Among them, the guide tube imaging part 53 can be made of radiopaque metal materials such as platinum, iridium, tantalum, gold, and stainless steel, and the shape can be annular or semi-circular or any other shape, and can be fixed to the corresponding tube wall or end position of the support guide tube 5 by forging or bonding or other forms. Additionally, optionally, axial scale lines are laser engraved or printed or otherwise provided on the outer peripheral surface of the dilation tube 3, and optionally, axial scale lines are laser engraved or printed or otherwise provided on the outer peripheral surface of the core wire 1.

[0084] For the convenience of operation, in the alternative embodiment of this embodiment, the dilation tube 3 and the support guide tube 5 are axially relatively positioned and can rotate relative to each other circumferentially. As Figures 1 to 9As shown, the support outer tube assembly 300 further includes an outer tube handle 6. The proximal end of the support guide tube 5 is detachably fixed in an axial through hole provided inside the outer tube handle 6, and a first clamping structure 601 is provided at the proximal end of the outer tube handle 6. The membrane expanding assembly 200 further includes an expansion tube handle 4. The proximal end of the expansion tube 3 is detachably fixed in an axial through hole provided inside the expansion tube handle 4. The expansion tube handle 4 is located on the proximal side of the outer tube handle 6, and a second clamping structure 401 is provided at the distal end of the expansion tube handle 4. The proximal end of the outer tube handle 6 is inserted and sleeved with the distal end of the expansion tube handle 4. At least one of the first clamping structure 601 and the second clamping structure 401 is a circumferential groove, and the other is a protrusion rotatably fitted inside the circumferential groove, so that the expansion tube handle 4 and the outer tube handle 6 can rotate relative to each other circumferentially, thereby driving the support outer tube and the expansion tube 3 to rotate relative to each other, and further enabling the support outer tube and the expansion tube 3 to be switched between a first relative position and a second relative position. To achieve the mutual clamping of the second clamping structure 401 of the expansion tube handle 4 and the first clamping structure 601 of the outer tube handle 6, the handle sleeved on the outside of the two handles can be spliced by two half shells or more shell units outside the handle located inside. The above structure can axially move the membrane expanding assembly 200 and the support outer tube assembly 300 synchronously during the surgical operation steps. Moreover, after the flaring is completed, the expansion tube handle 4 can be detached from the expansion tube 3, and the outer tube handle 6 can be detached from the support guide tube 5, so that the core wire 1 of the puncture and membrane rupture assembly 100 can be left as a guide wire to lower other subsequent instruments for subsequent surgical operations, without the need to completely withdraw the set and then re-lower the guide wire to implant the subsequent instruments, thus simplifying the surgical process.

[0085] In this alternative embodiment, further optionally, as Figures 1 to 4As shown in the figure, the support and guide tube 5 includes a tube body and a guide tube end component 501 connected to the proximal end of the tube body. An inner hole communicating with the lumen of the tube body is provided inside the guide tube end component 501. Among them, the guide tube end component 501 can be fixedly connected or detachably connected to the proximal end of the tube body, preferably by threaded connection, so as to remove the guide tube end component 501 to avoid interfering with the subsequent instrument from being inserted into the blood vessel along the core wire 1 when the core wire 1 of the puncture and membrane-breaking assembly 100 is used as a guide wire to insert other subsequent instruments. The outer tube handle 6 includes a first tube seat member 61, a second tube seat member 62, an end cap 63 and a tube seat seal 64, each of which is provided with an axial through hole inside. The axial through hole of the first tube seat member 61 is a first stepped hole 611 with a larger proximal aperture than the distal aperture, and a first positioning portion 6110 is provided on the proximal hole wall of the first stepped hole 611; the axial through hole of the end cap 63 is a second stepped hole 631 with a smaller proximal aperture than the distal aperture, and a second positioning portion 6310 is provided on the distal hole wall of the second stepped hole 631; proximal positioning portions 621 and distal positioning portions 622 are respectively provided on the outer peripheral walls at both axial ends of the second tube seat member 62; the inner diameter of the axial through hole of the tube seat seal 64 is configured to be able to pass through the core wire 1 and have an interference fit with the core wire 1. The tube body passes through the first stepped hole 611, and the guide tube end component 501 is blocked on the proximal side of the stepped surface of the first stepped hole 611; the distal end of the second tube seat member 62 is inserted into the proximal hole of the first stepped hole 611 and the distal positioning portion 622 is in concave-convex fit with the first positioning portion 6110, and the distal end face of the second tube seat member 62 abuts against the proximal end face of the guide tube end component 501; the tube seat seal 64 is arranged inside the first stepped hole 611 and is blocked on the distal side of the stepped surface of the first stepped hole 611; the proximal end of the second tube seat member 62 is inserted into the distal part of the second stepped hole 631 and the proximal positioning portion 621 is in concave-convex fit with the second positioning portion 6310, and the distal end face of the tube seat seal 64 abuts against the proximal end face of the second tube seat member 62, and blood leakage is prevented by the tube seat seal 64. The above-mentioned first clamping structure 601 is arranged at the proximal end of the end cap 63.

[0086] Optionally, as Figures 5 to 9 shown, the dilator handle 4 includes a distal handle fitting 41, a proximal handle fitting 42 and a handle seal 43, each of which is provided with an axial through hole inside. The proximal end of the dilator 3 is inserted and interference-fitted into the axial through hole of the handle seal 43. The axial through hole of the distal handle fitting 41 is a stepped hole with a larger proximal aperture than the distal aperture, and the handle seal 43 is arranged inside the proximal hole of the axial through hole of the distal handle fitting 41 and is blocked on the proximal side of the stepped surface of the axial through hole of the distal handle fitting 41. The distal end of the proximal handle fitting 42 is inserted and threadedly connected to the inside of the proximal hole of the axial through hole of the distal handle fitting 41, and the distal end face of the proximal handle fitting 42 abuts against the proximal end face of the handle seal 43, and blood leakage is prevented by the handle seal 43. The above-mentioned second clamping structure 401 is arranged at the distal end of the distal handle fitting 41.

[0087] The internal structures of the outer tube handle 6 and the dilatation tube handle 4 provided by the above two alternative embodiments of this embodiment can cooperate with the thinner tube section and / or the core wire 1. Moreover, the overall number of parts of the handle structure is small, the assembly is simple, it is easy to manufacture and easy for the operator to operate, which can save the manufacturing cost, reduce the operation difficulty and improve the surgical efficiency.

[0088] Finally, it should be noted that the above embodiments and their alternative embodiments in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing alternative embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that, without conflict, the features of the embodiments and the alternative embodiments in this specification can be combined with each other.

Claims

1. An in-situ fenestration and membrane puncture kit for an aortic stent graft, characterized in that: It comprises a membrane puncturing component (100), a membrane expanding component (200) and a supporting outer tube component (300); The membrane puncturing component (100) comprises a core wire (1); The membrane expansion assembly (200) comprises an expansion tube (3) axially slidably sleeved on the outside of the core wire (1); a portion of the expansion tube (3) close to the distal end is provided with a plurality of expansion wires (31) arranged at intervals along the circumference of the expansion tube (3) and extending in the axial direction of the expansion tube (3) in the length direction; in a free state, the plurality of expansion wires (31) expand outwardly in the radial direction of the expansion tube (3) to form an ellipsoidal shape; The supporting outer tube assembly (300) comprises a supporting guide tube (5) sleeved on the outside of the expansion tube (3), wherein a portion of the supporting guide tube (5) close to the distal end is provided with a plurality of long slits (511) arranged at intervals along the circumference of the supporting guide tube (5) and extending in the axial direction of the supporting guide tube (5) in the length direction; The expansion tube (3) and the support guide tube (5) are capable of axial sliding and / or circumferential rotation, so that when the two are in a first relative position, the multiple expansion wires (31) are constrained by the tube wall of the support guide tube (5) inside the support guide tube (5), and when the two are in a second relative position, the multiple expansion wires (31) expand out of the support guide tube (5) from the multiple long slits (511) respectively.

2. The aortic stent graft in situ fenestration and membrane puncture kit according to claim 1, characterized in that: The supporting guide tube (5) comprises a proximal straight guide tube section (51) and a distal arc-shaped guide tube section (52) pre-bent into an arc shape, and the long slit (511) is provided at the distal end of the proximal straight guide tube section (51).

3. The aortic stent graft in situ fenestration and membrane puncture kit according to claim 2, characterized in that: The arc length of the distal arc-shaped guiding tube segment (52) is L, and the angle between the tangent line at the distal end point of the distal arc-shaped guiding tube segment (52) and the distal side extension line of the proximal straight guiding tube segment (51) is α, then: 15mm≤L≤20mm, 20°≤α≤40°.

4. The aortic stent graft in situ fenestration and membrane puncture kit according to claim 1, characterized in that: A spiral tube slit (32) is also provided on the peripheral wall of the expansion tube (3) and is arranged in a spiral shape along the circumference of the expansion tube (3).

5. The aortic stent graft in situ fenestration and membrane puncture kit according to claim 1, characterized in that: The membrane puncturing assembly (100) further comprises a reed tube (2), the reed tube (2) being sleeved outside the distal end section of the core wire (1), and the distal end of the reed tube (2) being fixedly connected to the distal end of the core wire (1), and the proximal end of the reed tube (2) being fixedly connected to the outer peripheral surface of the core wire (1), the reed tube (2) comprising a large diameter section (21) connected in sequence from the proximal end to the distal end, a conical gradual section (22) whose diameter gradually decreases from the proximal end to the distal end, and a small diameter section (23).

6. The aortic stent graft in situ fenestration and membrane puncture kit according to claim 5, characterized in that: A spring developing portion (24) is respectively provided at the distal end of the large diameter section (21), the distal end of the tapered gradual change section (22), and the distal end of the small diameter section (23) of the spring tube (2).

7. The aortic stent graft in situ fenestration and membrane puncture kit according to claim 1, characterized in that: In the support guide tube (5), a guide tube developing portion (53) is provided at the proximal end point of the distal arc-shaped guide tube section (52) and at the distal end point of the entire support guide tube (5). And / or, an axial scale line is provided on the outer peripheral surface of the expansion tube (3); And / or, axial scale lines are provided on the outer peripheral surface of the core wire (1).

8. The aortic stent graft in situ fenestration and membrane puncture kit according to any one of claims 1 to 7, characterized in that: The expansion tube (3) and the support guide tube (5) are axially positioned relative to each other and are capable of circumferentially rotating relative to each other; The supporting outer tube assembly (300) further comprises an outer tube handle (6), the proximal end of the supporting guide tube (5) being detachably fixed in an axial through hole provided inside the outer tube handle (6), and the proximal end of the outer tube handle (6) being provided with a first clamping structure (601); The membrane expansion assembly (200) further comprises an expansion tube handle (4), the proximal end of the expansion tube (3) being detachably fixed in an axial through hole provided inside the expansion tube handle (4), the expansion tube handle (4) being located on the proximal side of the outer tube handle (6), and a second clamping structure (401) being provided at the distal end of the expansion tube handle (4); The proximal end of the outer tube handle (6) is connected to the distal end sleeve of the expansion tube handle (4); at least one of the first clamping structure (601) and the second clamping structure (401) is a circumferential groove, and the other is a protrusion rotatably fitted in the interior of the circumferential groove, so that the expansion tube handle (4) and the outer tube handle (6) can rotate relative to each other in the circumferential direction, thereby causing the supporting outer tube and the expansion tube (3) to rotate relative to each other and thus switching the supporting outer tube and the expansion tube (3) between the first relative position and the second relative position.

9. The aortic stent graft in situ fenestration and membrane puncture kit according to claim 8, characterized in that: The supporting guide tube (5) comprises a tube body and a guide tube end component (501) connected to the proximal end of the tube body, and the guide tube end component (501) is provided with an inner hole communicating with the tube cavity of the tube body; The outer tube handle (6) comprises a tube seat member 1 (61), a tube seat member 2 (62), an end cover (63) and a tube seat sealing member (64), each of which has an axial through hole therein; The axial through hole of the first tube seat member (61) is a first stepped hole (611) whose proximal diameter is larger than the distal diameter, and a first positioning portion (6110) is provided on the proximal hole wall of the first stepped hole (611); the axial through hole of the end cover (63) is a second stepped hole (631) whose proximal diameter is smaller than the distal diameter, and a second positioning portion (6310) is provided on the distal hole wall of the second stepped hole (631); the outer peripheral walls at the axial ends of the second tube seat member (62) are respectively provided with a proximal positioning portion (621) and a distal positioning portion (622); the inner diameter of the axial through hole of the tube seat seal (64) is configured to be able to pass through the core wire (1) and to have an interference fit with the core wire (1); The tube body passes through the first stepped hole (611), and the guide tube end component (501) is blocked at the proximal side of the stepped surface of the first stepped hole (611); the distal end of the second tube seat component (62) is inserted into the proximal hole of the first stepped hole (611), and the distal end positioning portion (622) is matched with the first positioning portion (6110) in a concave-convex manner, and the distal end surface of the second tube seat component (62) abuts against the proximal end of the guide tube end component (501). The proximal end surface of the tube seat seal (64) is arranged inside the first stepped hole (611) and is blocked at the distal end side of the stepped surface of the first stepped hole (611); the proximal end of the second tube seat member (62) is inserted into the distal end of the second stepped hole (631) and the proximal end positioning portion (621) and the second positioning portion (6310) are matched in a concave-convex manner, and the distal end surface of the tube seat seal (64) is in contact with the proximal end surface of the second tube seat member (62); The first clamping structure (601) is arranged at the proximal end of the end cover (63).

10. The in situ fenestration and membrane puncture kit for aortic stent graft according to claim 8, characterized in that: The expansion tube handle (4) comprises a distal handle accessory (41), a proximal handle accessory (42) and a handle seal (43), each of which has an axial through hole therein; The proximal end of the expansion tube (3) is inserted into and connected by interference fit to the interior of the axial through hole of the handle sealing member (43); The axial through hole of the distal handle accessory (41) is a stepped hole with a proximal hole diameter larger than a distal hole diameter, and the handle seal (43) is arranged inside the proximal hole of the axial through hole of the distal handle accessory (41) and is blocked at the proximal side of the stepped surface of the axial through hole of the distal handle accessory (41); The distal end of the proximal handle accessory (42) is inserted into and threadedly connected to the interior of the proximal hole of the axial through hole of the distal handle accessory (41), and the distal end surface of the proximal handle accessory (42) abuts against the proximal end surface of the handle seal (43); The second clamping structure (401) is arranged at the distal end of the distal handle accessory (41).

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