Aorta covered stent in-situ windowing puncture membrane rupture set

Abstract

The invention provides an aorta covered stent in-situ windowing puncture membrane rupture set, which relates to the field of medical instruments and comprises a puncture membrane rupture assembly, a membrane expansion assembly and a support outer tube assembly, comprising a core wire, an expansion tube and a supporting guide tube, the portion, close to the far end, of the expansion tube is provided with a plurality of expansion wires which expand outwards in the radial direction in the free state and are in an ellipsoid shape. A plurality of long slots are formed in the part, close to the far end, of the supporting guide pipe; the expansion pipe and the supporting guide pipe can axially slide and / or circumferentially rotate, so that when the expansion pipe and the supporting guide pipe are located at the first relative position, the multiple expansion wires are restrained in the supporting guide pipe by the pipe wall of the supporting guide pipe, and when the expansion pipe and the supporting guide pipe are located at the second relative position, the multiple expansion wires expand out of the supporting guide pipe from the multiple long open seams correspondingly. The aorta covered stent can be applied to in-situ fenestration, after the aorta covered stent fenestration membrane rupture point is accurately positioned, the membrane is quickly ruptured, and the opening after membrane rupture is quickly flared.

Description

Technical Field

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

[0002] Stent treatment of aortic aneurysm is characterized by less trauma and quick recovery, and is particularly suitable for patients who have undergone previous surgery and are at great risk. The stent graft is implanted into the aneurysm, and the normal arteries at the proximal and distal ends of the aneurysm are connected through the stent graft. Arterial blood flow no longer fills the aneurysm body, and the aortic aneurysm body will slowly thrombose, thereby isolating the aortic aneurysm.

[0003] Since the aorta has many important branch vessels, such as the subclavian artery, celiac trunk, renal artery, mesenteric artery, etc., these branch vessels provide blood supply to important organs of the body. Therefore, when some aortic aneurysms involve these important branch vessels, we cannot directly isolate the aortic aneurysm with a covered stent, because this will cover these important branch vessels at the same time, causing insufficient blood supply to important organs. As a result, the aortic aneurysm stent fenestration technology was developed, that is, the film at the corresponding part of the covered stent and the opening of each branch vessel is removed to form a window to ensure the normal blood supply of important branch vessels after the covered stent is implanted. This technology mainly includes pre-fenestration and in situ fenestration. Pre-fenestration is to combine medical imaging equipment to image the patient's lesion site before implanting the covered stent, calculate the precise position of the important branch vessels on the covered stent, remove the film on this part of the covered stent to form a window, and then implant the covered stent after the window into the patient's artery; in situ fenestration is to first implant the covered stent into the patient's artery, and then open the window on the side of the covered stent through the branch vessels. Because of the differences in lesion location, vessel size, and branch vessel opening sites among aortic aneurysm patients, in situ fenestration is preferred.

[0004] As for the more specific surgical method of in situ fenestration, the existing technology generally uses imaging equipment to perform angiography of the lesion site. Under the guidance of the imaging equipment, medical staff locate the branch blood vessel opening on the surface of the aortic stent graft, introduce the sheath from the femoral artery or brachial artery into the aorta, and send a guiding catheter with different head angles along the sheath to align the catheter head with the branch opening angle. A guide wire is sent along the guiding catheter to pierce the membrane on the aortic stent graft where a window is required, and then the guiding catheter is withdrawn. Then a balloon catheter for membrane expansion is inserted along the guide wire for expansion, thereby completing the in situ fenestration.

[0005] However, the guidewire used in the traditional in situ fenestration and membrane rupture method is a conventional guidewire. There are problems with the inaccurate position of the tip of the guidewire due to the guidewire being too soft or too hard, resulting in different degrees of lack of effective support in the guiding catheter or weak support point strength. There are also problems with the tip of the guidewire being difficult to pierce the membrane after positioning due to inappropriate size conditions such as the guidewire being too thick or too thin. The above problems lead to safety hazards such as complicated surgical operations and long operation times.

[0006] In addition, since the opening of the membrane rupture point is much smaller than the tip of the balloon catheter, the balloon will be stuck and unable to pass through after the tip contacts the membrane during the process of entering along the guidewire after the membrane ruptures. To solve this problem, doctors currently shape the tip of the balloon catheter by cutting, squeezing, etc. and then insert it. However, such an operation has the risk that the tip of the catheter affects the smoothness of the catheter inside the blood vessel or easily damages the blood vessel or brings in foreign objects to cause thrombosis. In addition, the on-site shaping operation also prolongs the operation time and increases the safety risks of the operation. Summary of the invention

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

[0008] To achieve the above objectives, the embodiments of the present invention adopt the following technical solutions: The embodiment of the present invention provides an aortic stent graft in situ fenestration and membrane puncture kit, comprising a membrane puncture component, a membrane expansion component and a supporting outer tube component; The membrane puncturing component comprises a core wire; The membrane expansion assembly comprises an expansion tube axially slidably sleeved on the outside of the core wire; a portion of the expansion tube close to the distal end is provided with a plurality of expansion wires arranged at intervals along the circumference of the expansion tube and extending along the axial direction of the expansion tube in the length direction; in a free state, the plurality of expansion wires expand outwardly along the radial direction of the expansion tube to form an ellipsoidal shape; The support outer tube assembly comprises a support guide tube sleeved on the outside of the expansion tube, and a portion of the support guide tube close to the distal end is provided with a plurality of long slits arranged at intervals along the circumference of the support guide tube and extending in the axial direction of the support guide tube in the length direction; The expansion tube and the support guide tube are capable of axial sliding and / or circumferential rotation, so that when the two are in a first relative position, the multiple expansion wires are constrained by the tube wall of the support guide tube inside the support guide tube, and when the two are in a second relative position, the multiple expansion wires expand out of the support guide tube respectively from the multiple long slits.

[0009] In an optional embodiment, the supporting guide tube includes a proximal straight guide tube section and a distal arc-shaped guide tube section pre-bent into an arc shape, and the long slit is provided at the distal end of the proximal straight guide tube section.

[0010] In an optional embodiment, the arc length of the distal arc-shaped guide tube segment is L, and the angle between the tangent at the distal endpoint of the distal arc-shaped guide tube segment and the distal side extension line of the proximal straight guide tube segment is α, then: 15mm≤L≤20mm, 20°≤α≤40°.

[0011] In an optional embodiment, a spiral tube slit arranged in a spiral shape along the circumference of the expansion tube is further provided on the peripheral wall of the expansion tube.

[0012] In an optional embodiment, the puncture membrane assembly also includes a spring tube, which is sleeved on the outside of the distal segment of the core wire, and the distal end of the spring tube is fixedly connected to the distal end of the core wire, and the proximal end of the spring tube is fixedly connected to the outer circumferential surface of the core wire, and the spring tube includes a large diameter section, a conical gradient section whose diameter gradually decreases from the proximal end to the distal end, and a small diameter section which are connected in sequence from the proximal end to the distal end.

[0013] In an optional embodiment, a spring developing portion is provided at the distal end of the large diameter section, the distal end of the tapered gradient section, and the distal end of the small diameter section of the spring tube, respectively.

[0014] In an optional embodiment, in the support guide tube, a guide tube developing portion is provided at the proximal end point of the distal arc-shaped guide tube segment and at the distal end point of the support guide tube as a whole; and / or, an axial scale line is provided on the outer circumference of the expansion tube; And / or, axial scale lines are provided on the outer peripheral surface of the core wire.

[0015] In an optional embodiment, the expansion tube and the support guide tube are axially positioned relative to each other and can rotate relative to each other circumferentially; The supporting outer tube assembly further comprises an outer tube handle, the proximal end of the supporting guide tube is detachably fixed in an axial through hole provided inside the outer tube handle, and the proximal end of the outer tube handle is provided with a first clamping structure; The membrane expansion assembly also includes an expansion tube handle, the proximal end of the expansion tube can be detachably fixed in an axial through hole provided inside the expansion tube handle, the expansion tube handle is located at the proximal end side of the outer tube handle, and a second clamping structure is provided at the distal end of the expansion tube handle; The proximal end of the outer tube handle is connected to the distal end sleeve of the expansion tube handle, and 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 expansion tube handle and the outer tube handle can rotate relative to each other in the circumferential direction, thereby causing the supporting outer tube and the expansion tube to rotate relative to each other and thereby switching the supporting outer tube and the expansion tube between the first relative position and the second relative position.

[0016] In an optional embodiment, the support guide tube includes a tube body and a guide tube end component connected to the proximal end of the tube body, and the guide tube end component is provided with an inner hole communicating with the tube cavity of the tube body; The outer tube handle comprises a tube seat member 1, a tube seat member 2, an end cover and a tube seat sealing member, each of which has an axial through hole therein; The axial through hole of the first tube seat member is a first stepped hole with a proximal hole diameter larger than a distal hole diameter, and a first positioning portion is provided on the proximal hole wall of the first stepped hole; the axial through hole of the end cover is a second stepped hole with a proximal hole diameter smaller than a distal hole diameter, and a second positioning portion is provided on the distal hole wall of the second stepped hole; the outer peripheral walls at both axial ends of the second tube seat member are respectively provided with a proximal positioning portion and a distal positioning portion; the inner diameter of the axial through hole of the tube seat seal is configured to be able to pass through the core wire and to have an interference fit with the core wire; The tube body passes through the first stepped hole, and the guide tube end component is blocked at the proximal side of the stepped surface of the first stepped hole; the distal end of the second tube seat component is inserted into the proximal hole of the first stepped hole, and the distal end positioning portion is matched with the first positioning portion in a concave-convex manner, and the distal end surface of the second tube seat component abuts against the proximal end surface of the guide tube end component; the tube seat sealing component is arranged in the first stepped hole and is blocked at the distal side of the stepped surface of the first stepped hole; the proximal end of the second tube seat component is inserted into the distal end of the second stepped hole, and the proximal end positioning portion is matched with the second positioning portion in a concave-convex manner, and the distal end surface of the tube seat sealing component abuts against the proximal end surface of the second tube seat component; The first clamping structure is arranged at the proximal end of the end cover.

[0017] In an optional embodiment, the expansion tube handle includes a distal handle fitting, a proximal handle fitting and a handle seal, each of which has an axial through hole therein; The proximal end of the expansion tube is inserted into and connected to the interior of the axial through hole of the handle seal by interference fit; The axial through hole of the distal handle accessory is a stepped hole with a proximal hole diameter larger than a distal hole diameter, and the handle seal is arranged inside the proximal hole of the axial through hole of the distal handle accessory and is blocked at the proximal side of the stepped surface of the axial through hole of the distal handle accessory; The distal end of the proximal handle accessory is inserted into and threadedly connected to the interior of the proximal hole of the axial through hole of the distal handle accessory, and the distal end surface of the proximal handle accessory abuts against the proximal end surface of the handle seal; The second clamping structure is arranged at the distal end of the distal handle accessory.

[0018] In particular, in the embodiments of the present invention, “and / or” indicates that the first feature before “and / or” and the second feature after “and / or” include the following specific setting methods: (1) only the first feature is set, and the second feature is not set; (2) only the second feature is set, and the first feature is not set; (3) the first feature and the second feature are set at the same time.

[0019] This embodiment can at least achieve the following beneficial effects: The aortic stent graft puncture and membrane rupture kit provided in this embodiment is used in in situ fenestration. When rupturing the membrane, the core wire is supported, guided and positioned by the support guide tube of the supporting outer tube assembly to improve the precise positioning of the membrane rupture point. After rupturing the membrane, the membrane rupture point opening is quickly expanded by the expansion tube of the expansion assembly without the need to additionally insert a balloon catheter for expansion. The operation process is simpler and the operation is more efficient. More importantly, the expansion tube and the supporting guide tube can slide axially and / or rotate circumferentially, so that when the two are in a first relative position, the multiple expansion wires are constrained by the tube wall of the supporting guide tube to the inside of the supporting guide tube, and when the two are in a second relative position, the multiple expansion wires of the expansion tube expand out of the outside of the supporting guide tube respectively from the multiple long slits of the supporting guide tube. Combined with the fourth and fifth surgical steps, the multiple expansion wires of the expansion tube can easily enter and exit the membrane rupture point opening under the constraint of the supporting guide tube, and there will be no jamming. The expansion process is smoother and the operation risk during the operation is effectively reduced. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0021] Figure 1 A schematic diagram of the overall structure of the puncture and membrane rupture assembly in the in-situ fenestration and membrane rupture kit for the aortic stent graft provided by an embodiment of the present invention; Figure 2 for Figure 1 Magnified view of local structures in the mid-distal region; Figure 3 for Figure 1 A magnified view of the local structure in the mid-proximal region; Figure 4 for Figure 3 An exploded schematic diagram of the structure shown; Figure 5 A schematic diagram of the overall structure of the membrane expansion component in the in-situ fenestration and membrane puncture kit for the aortic stent graft provided by an embodiment of the present invention; Figure 6 for Figure 5 Schematic diagram of the explosion structure; Figure 7 for Figure 6 Magnified view of local structures in the mid-distal region; Figure 8 for Figure 6 A magnified view of the local structure in the mid-proximal region; Fig. 9 for Figure 5 A schematic diagram of a state in which the expansion wire in the distal region of the expansion tube in the expansion membrane assembly is radially constrained; Fig.10 A fracture view of the overall structure of the puncture and membrane rupture component in the in-situ fenestration and membrane rupture kit for the aortic stent graft provided by an embodiment of the present invention; Fig.11 for Fig.10 Schematic diagram of the local structure of the distal end area of ​​the mid-puncture membrane rupture component; Fig.12 Schematic diagram of the use steps of the aortic stent graft in situ fenestration and membrane puncture kit provided in an embodiment of the present invention Figure 1 ; Fig.13 Schematic diagram of the use steps of the in situ fenestration and membrane puncture kit for the aortic stent graft provided in an embodiment of the present invention Figure 2 ; Fig.14 Schematic diagram of the use steps of the in situ fenestration and membrane puncture kit for the aortic stent graft provided in an embodiment of the present invention Figure 3 ; Fig.15 This is a schematic diagram of the distal contact portion when the supporting outer tube assembly contacts the membrane of the aortic stent graft when the in situ fenestration and membrane puncture kit of the aortic stent graft provided by an embodiment of the present invention is used.

[0022] Icon: 100- puncture membrane component; 1- core wire; 2- spring tube; 21- large diameter section; 22- tapered gradient section; 23- small diameter section; 24- spring development section; 200-expansion assembly; 3-expansion tube; 31-expansion wire; 32-spiral tube seam; 4-expansion tube handle; 401-second clamping structure; 41-distal handle accessory; 42-proximal handle accessory; 43-handle seal; 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-shaped guide tube section; 53-guide tube developing section; 6-outer tube handle; 601-first clamping structure; 61-tube seat member 1; 611-first stepped hole; 6110-first positioning portion; 62-tube seat member 2; 621-proximal positioning portion; 622-distal positioning portion; 63-end cover; 631-second stepped hole; 6310-second positioning portion; 64-tube seat sealing member; 400-Aortic Stent Graft. DETAILED DESCRIPTION

[0023] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0024] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] It should be noted that like reference numerals and letters denote similar items in the drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0026] In the description of the present invention, it should be noted that: Unless otherwise clearly specified and limited, the terms "disposed", "installed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be a communication between the two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0027] The orientation or position relationship indicated by the terms "proximal", "distal", "front end", "rear end", "axial", "radial", "circumferential", "inner" and "outer" are based on the orientation or position relationship shown in the drawings, or are the orientation or position relationship in which the product of the invention is usually placed when used. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0028] The terms “first”, “second”, etc. are only used for distinguishing descriptions and do not indicate the total number or relative position in time and / or space, and cannot be understood as indicating or implying relative importance.

[0029] Below, some embodiments of the present invention are described in detail in conjunction with the accompanying drawings, with the end of the medical device close to the operator during surgery being the proximal end of the medical device, and the end of the medical device entering the patient's blood vessel being the distal end of the medical device (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).

[0030] Reference Figures 1 to 15 This embodiment provides an aortic covered stent in situ fenestration and membrane puncture kit, which includes a membrane puncture component 100, a membrane expansion component 200 and a supporting outer tube component 300.

[0031] Wherein: the puncturing membrane assembly 100 includes a core wire 1. The membrane expansion assembly 200 includes an expansion tube 3 axially slidably sleeved on the outside of the core wire 1; the expansion tube 3 near 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 along the axial direction of the expansion tube 3 in the length direction. In a free state, the plurality of expansion wires 31 expand outwardly along the radial direction of the expansion tube 3 to form an ellipsoid shape. The expansion wires 31 can be selected from but not limited to being cut from the expansion tube 3. The supporting outer tube assembly 300 includes a supporting guide tube 5 sleeved on the outside of the expansion tube 3. The supporting guide tube 5 near 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 along the axial direction of the supporting guide tube 5 in the length direction.

[0032] The expansion tube 3 and the supporting 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 supporting guide tube 5 inside the supporting guide tube 5, and when the two are in a second relative position, the multiple expansion wires 31 of the expansion tube 3 expand out of the supporting guide tube 5 from the multiple long slits 511 of the supporting guide tube 5 respectively.

[0033] When using, refer to the surgical procedure steps Figures 12 to 15 : The first step is to insert a guide wire into the branch vessel of the aorta to be fenestrated in situ to the lesion site under percutaneous puncture; The second step is to insert the combination of the membrane expansion component 200 and the supporting outer tube component 300 in the set provided by the present invention along the guide wire, so that the distal end surface of the supporting guide tube 5 in the supporting outer tube component 300 is completely fitted with the membrane of the pre-windowed area on the side of the aortic covered stent 400; The third step is to axially pass the core wire 1 of the membrane puncturing component 100 through the expansion tube 3 of the membrane expansion component 200, and push the membrane puncturing component 100 forward (distal end) relative to the supporting outer tube component 300, so that the distal end of the supporting outer tube component 300 is pushed forward to penetrate the membrane of the aortic stent graft 400; In the fourth step, the membrane puncturing component 100, the membrane expansion component 200 and the supporting outer tube component 300 are pushed forward (they can be pushed forward simultaneously or separately, and during the process, it is ensured that the expansion tube 3 and the supporting guide tube 5 are always in the first relative position), or the membrane expansion component 200 and the supporting outer tube component 300 are pushed forward along the membrane puncturing component 100 (they can be pushed forward simultaneously or separately, and during the process, it is ensured that the expansion tube 3 and the supporting guide tube 5 are always in the first relative position), until the long slit 511 of the supporting guide tube 5 enters the pierced hole on the membrane of the aortic stent graft 400; The fifth step is to move the membrane expansion component 200 relative to the supporting outer tube component 300, so that the supporting guide tube 5 moves relative to the expansion tube 3, until the expansion tube 3 and the supporting guide tube 5 are in the second relative position, and the multiple expansion wires 31 of the expansion tube 3 expand out of the supporting guide tube 5 from the multiple long slits 511 of the supporting guide tube 5 respectively, and then the supporting outer tube component 300 and the membrane expansion component 200 are circumferentially rotated relative to the core wire 1 of the puncturing membrane component 100, so that the multiple expansion wires 31 with an ellipsoidal outer contour after expansion rotate circumferentially to expand the pierced hole on the membrane of the aortic covered stent 400; The sixth step is to move the membrane expansion component 200 relative to the supporting outer tube component 300 after the hole expansion is completed, so that the supporting guide tube 5 moves relative to the expansion tube 3 until the expansion tube 3 and the supporting guide tube 5 are in the first relative position, and withdraw the supporting outer tube component 300 and the membrane expansion component 200 backward (proximal end) along the puncture membrane component 100, and retain the core wire 1 of the puncture membrane component 100 as a guide wire to insert other rear instruments for subsequent surgical operations.

[0034] The aortic stent graft 400 puncture and membrane rupture kit provided in this embodiment is used in in situ fenestration. When the membrane is ruptured, the core wire 1 is supported and guided by the support guide tube 5 of the supporting outer tube component 300 to improve the accurate positioning of the membrane rupture point. After the membrane is ruptured, the expansion tube 3 of the membrane expansion component 200 is used to quickly expand the opening of the membrane rupture point without the need to insert an additional balloon catheter for expansion. The operation process is simpler and the operation is more efficient. More importantly, the expansion tube 3 and the support guide tube 5 can slide axially and / or rotate circumferentially to allow the two to move in a straight line. When the two are in the first relative position, the multiple expansion wires 31 are constrained by the tube wall of the supporting guide tube 5 inside the supporting guide tube 5, and when the two are in the second relative position, the multiple expansion wires 31 of the expansion tube 3 expand out of the supporting guide tube 5 from the multiple long slits 511 of the supporting guide tube 5 respectively. Combined with the fourth and fifth steps of the surgical procedure, the multiple expansion wires 31 of the expansion tube 3 can easily enter and exit the membrane rupture point opening under the constraint of the supporting guide tube 5, and there will be no sticking phenomenon. The expansion process is smoother and the operational risk during the operation is effectively reduced.

[0035] In an optional implementation of this embodiment, in order to further improve the smoothness of the support guide tube 5 and the expansion tube 3 inside it entering and exiting the membrane breaking point opening during the expansion process, refer to Fig.10 and Fig.11 The membrane puncturing assembly 100 also includes a spring tube 2, which is sleeved on the outside of the distal end of the core wire 1, and the distal end of the spring tube 2 is fixedly connected to the distal end of the core wire 1, and the proximal end of the spring tube 2 is fixedly connected to the outer circumferential surface of the core wire 1. The spring tube 2 includes a large diameter section 21, a conical gradient section 22 whose diameter gradually decreases from the proximal end to the distal end, and a small diameter section 23. In the third step of the surgical operation, when puncturing the membrane of the aortic stent graft 400, the distal end of the small diameter section 23 of the coil spring tube 2 is used as the puncture end for puncture, and the large diameter section 21 of the coil spring tube 2 performs the first pre-expansion of the punctured membrane opening under the guidance of the tapered gradient section 22 of the coil spring tube 2, which is more conducive to the use of multiple expansion wires 31 of the expansion tube 3 to expand from the multiple long slits 511 of the supporting guide tube 5 to expand the membrane opening for secondary expansion in the fourth to sixth steps, and the supporting guide tube 5 and the expansion tube 3 inside the expansion tube 3 are in the first relative position. When the two are in the first relative position, they can smoothly enter and exit the membrane opening. Optionally, in order to adapt to the overall shape of the coil spring tube 2, the distal end section of the core wire 1 is designed to be a tapered structure similar to the coil spring tube 2. For ease of manufacturing, the proximal end of the large diameter section 21 of the coil spring tube 2 can be but not limited to a connecting sleeve, which is sleeved and fixedly connected to the outer peripheral wall of the core wire 1.

[0036] In this optional embodiment, in order to further facilitate the operator's operation, optionally, a spring developing portion 24 is provided at the distal end of the large diameter section 21, the distal end of the conical gradient section 22 and the distal end of the small diameter section 23 of the spring tube 2, so that the operator can clearly view the position of the spring tube 2 with the assistance of a developing device, wherein the spring developing portion 24 can be made of, but not limited to, radiopaque metal materials such as platinum, iridium, tantalum, gold, stainless steel, etc., and can be annular, semicircular or any other shape, and can be fixed to the intersection of the core wire 1 or the spring tube 2 at the intersection of the tube sections by forging, pressing or bonding.

[0037] In an optional implementation of this embodiment, in order to further increase the accuracy of locating the location of the membrane rupture point on the aortic stent graft 400, refer to Figure 1 and Figure 2 The supporting guide tube 5 includes 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. Fig.15 When the aortic covered stent 400 is implanted in the aortic arch blood vessel, the arc design of the distal arc-shaped guide tube segment 52 is more conducive to making the distal end face of the supporting guide tube 5 fit with the membrane of the aortic covered stent 400, and then guiding the distal end of the core wire 1 to puncture along a perpendicular direction to the membrane of the aortic covered stent 400, thereby avoiding various subsequent adverse problems caused by the deviation of the window position on the aortic covered stent 400.

[0038] In this optional embodiment, it is more preferred but not limited to that in the support guide tube 5, the arc length of its distal arc-shaped guide tube segment 52 is L, and the angle between the tangent at the distal end point of the distal arc-shaped guide tube segment 52 and the distal side extension line of the proximal straight guide tube segment 51 is α, then: 15mm≤L≤20mm, 20°≤α≤40°, for example but not limited to L is 15mm or 20mm or any length between 15mm~20mm, α is 20° or 40° or any angle between 20°~40°. This arc length and angle range is suitable for the blood vessel size of the aortic arch area of ​​most patients, and is more conducive to ensuring that the distal end of the above-mentioned guide core wire 1 is punctured along the membrane perpendicular to the aortic stent graft 400.

[0039] 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 difficulty of the operator's operation. In this regard, in an optional implementation of this embodiment, a spiral tube seam 32 is also provided on the peripheral wall of the expansion tube 3 and is spirally arranged along the circumference of the expansion tube 3. Thereby, the hardness of the expansion tube 3 is reduced and the flexibility of the tube layer structure during delivery is improved.

[0040] In order to facilitate the operator to accurately control the delivery position of the support guide tube 5 and the expansion tube 3 inside the blood vessel, in an optional implementation of this embodiment, 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 support guide tube 5 as a whole are respectively provided with a guide tube developing portion 53, wherein the guide tube developing portion 53 can be made of, but not limited to, radiopaque metal materials such as platinum, iridium, tantalum, gold, stainless steel, etc., and can be annular or semicircular or other arbitrary shapes, and can be fixed to the corresponding tube wall or end position of the support guide tube 5 by forging or bonding. In addition, optionally, the outer peripheral surface of the expansion tube 3 is laser engraved or printed or otherwise provided with axial scale lines, and optionally, the outer peripheral surface of the core wire 1 is laser engraved or printed or otherwise provided with axial scale lines.

[0041] For ease of operation, in an optional implementation of this embodiment, the expansion tube 3 and the support guide tube 5 are axially positioned relative to each other and can rotate relative to each other circumferentially. Figures 1 to 9 As shown, the outer tube support assembly 300 also includes an outer tube handle 6, the proximal end of the support guide tube 5 can be detachably fixed in the axial through hole provided inside the outer tube handle 6, and the proximal end of the outer tube handle 6 is provided with a first clamping structure 601. The membrane expansion assembly 200 also includes an expansion tube handle 4, the proximal end of the expansion tube 3 can be detachably fixed in the axial through hole provided inside the expansion tube handle 4, the expansion tube handle 4 is located at 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 connected with the distal end plug 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 that is rotatably matched with the inside 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 driving the support outer tube and the expansion tube 3 to rotate relative to each other and thus switching the support outer tube and the expansion tube 3 between the first relative position and the second relative position. In order to realize 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 set on the outside of the two handles can be spliced ​​on the outside of the handle located inside by two half shells or more shell units. The above structure can synchronously move the membrane expansion component 200 and the supporting outer tube component 300 axially during the surgical operation steps, and after the expansion is completed, the expansion tube handle 4 can be separated from the expansion tube 3, and the outer tube handle 6 can be separated from the supporting guide tube 5, so that the core wire 1 of the puncture membrane component 100 is retained as a guide wire to be inserted into other instruments for subsequent surgical operations, without the need to completely withdraw the set and then re-insert the guide wire to implant the instruments, thereby simplifying the surgical process.

[0042] In this optional implementation, further optionally, as Figures 1 to 4As shown, the support guide tube 5 includes a tube body and a guide tube end component 501 connected to the proximal end of the tube body, wherein the guide tube end component 501 is provided with an inner hole communicating with the tube cavity of the tube body, wherein the guide tube end component 501 can be fixedly connected or detachably connected to the proximal end of the tube body, preferably threadedly connected, so that when the core wire 1 of the puncture membrane assembly 100 is retained as a guide wire to be inserted into other rear instruments for subsequent surgical operations, the guide tube end component 501 can be removed to avoid interfering with the rear instruments being inserted into the blood vessel along the core wire 1. The outer tube handle 6 includes a tube seat component 1 61, a tube seat component 2 62, an end cover 63 and a tube seat seal 64, each of which has an axial through hole therein. The axial through hole of the tube seat member 61 is a first stepped hole 611 whose proximal aperture is larger 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 cover 63 is a second stepped hole 631 whose proximal aperture is smaller than the distal aperture, and a second positioning portion 6310 is provided on the distal hole wall of the second stepped hole 631; a proximal positioning portion 621 and a distal positioning portion 622 are respectively provided on the outer peripheral walls at the axial ends of the tube seat member 2 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 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 surface of the guide tube end component 501; the tube seat seal 64 is arranged inside the first stepped hole 611 and blocked at the distal side of the stepped surface of the first stepped hole 611; the proximal end of the second tube seat component 62 is inserted into the distal end of the second stepped hole 631, and the proximal end positioning portion 621 is matched with the second positioning portion 6310 in a concave-convex manner, and the distal end surface of the tube seat seal 64 abuts against the proximal end surface of the second tube seat component 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 cover 63.

[0043] Alternatively, if Figures 5 to 9 As shown, the expansion tube handle 4 includes a distal handle accessory 41, a proximal handle accessory 42 and a handle seal 43, each of which is provided with an axial through hole. The proximal end of the expansion tube 3 is inserted into and connected to the inside of the axial through hole of the handle seal 43 by interference fit. The axial through hole of the distal handle accessory 41 is a stepped hole with a proximal aperture larger than the distal aperture. The handle seal 43 is arranged inside the proximal hole of the axial through hole of the distal handle accessory 41 and is blocked on 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 inside of the proximal hole of the axial through hole of the distal handle accessory 41, and the distal surface of the proximal handle accessory 42 abuts against the proximal surface 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 accessory 41.

[0044] The internal structures of the outer tube handle 6 and the expansion tube handle 4 provided in the above two optional implementations of this embodiment can be matched with the tube segment and / or the core wire 1 with a smaller diameter, and the overall number of parts of the handle structure is small, the assembly is simple, it is easy to manufacture, and it is easy for the operator to operate and use, which can save production costs, reduce operating difficulty, and improve surgical efficiency.

[0045] Finally, it should be noted that the above embodiments and their optional implementation modes in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit them. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned optional implementation modes, or replace some or all of the technical features therein by equivalents. These modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention. In addition, it is emphasized again that the features of the embodiments in this specification and the optional implementation modes in the embodiments can be combined with each other without conflict.

Claims

1. An in-situ fenestration and membrane 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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