A covered stent, endovascular implant assembly, and delivery system

Abstract

The present application belongs to the technical field of medical devices, and relates to a covered stent, an intravascular implant assembly and a delivery system. The covered stent comprises a stent body and a filling tube arranged in the stent body, the filling tube is provided with a filling channel, and the inner cavity of the stent body is in communication with the outside of the stent body through the filling channel; the covered stent delivery system comprises the covered stent and a covered stent delivery device for delivering the covered stent. The intravascular implant assembly comprises the covered stent and a vascular tumor cavity implant; the intravascular implant assembly delivery system comprises the intravascular implant assembly and an implant assembly delivery device for delivering the intravascular implant assembly. Compared with the prior art, the present application reserves a filling channel in the covered stent, and after the covered stent is implanted, the vascular tumor cavity implant can be delivered into the vascular tumor cavity through the filling channel to fill the vascular tumor cavity, so that the operation difficulty and the surgical risk are reduced, and the safety is improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology and relates to a covered stent, component and system. Background Technology

[0002] One of the main treatments for existing vascular lesions, such as aneurysms, is endovascular repair (EVAR). This involves implanting a covered stent at the lesion site, using a polymer membrane to isolate the lesion neck and prevent blood flow from impacting the lesion wall and causing rupture. The original lesion cavity is sealed by the covered stent, preventing blood flow and forming a thrombus within the cavity, thus achieving the therapeutic goal. However, in actual surgery, due to the variability in the shape of the lesion neck, the contact point between the neck and the covered stent often cannot be effectively sealed, resulting in a certain "endoleak" effect and causing secondary recurrence of the vascular lesion.

[0003] To prevent recurrence, during covered stent implantation surgery, surgeons typically fill the aneurysm cavity with implants such as coils or bio-adhesive to create a filling and embolizing effect, significantly reducing the recurrence rate. However, this procedure is very complex. The covered stent often needs to be kept in a partially released state. A microcatheter is then inserted into the aneurysm cavity through the gap between the vessel wall and the partially released stent. The implant is then filled into the cavity using the microcatheter. The covered stent is then fully released to retain the implant within the cavity. Finally, the microcatheter is withdrawn from between the vessel wall and the fully released stent. However, because the microcatheter is clamped between the vessel wall and the fully released stent after complete release, the stent can easily shift or misalign during microcatheter withdrawal, leading to adverse clinical events.

[0004] To avoid the aforementioned problems, another approach involves separating the implantation of the covered stent from the filling of the hemangioma cavity. This involves first implanting the covered stent at the hemangioma site, and then, under ultrasound guidance, using a syringe to directly puncture the cavity from outside the patient and inject the filling material. However, this procedure requires highly skilled surgeons, involves a longer puncture distance, is susceptible to interference from the patient's abdominal organs, and carries the risk of the filling material being left inside the abdominal cavity. Summary of the Invention

[0005] The purpose of this invention is to provide a covered stent, component, and system that can effectively block hemangiomas, reduce operational difficulty, and improve safety.

[0006] The objective of this invention can be achieved through the following technical solutions: The first aspect of the present invention provides a covered stent, the covered stent including a stent body and a filling tube disposed within the stent body, the filling tube having a filling channel, and the inner cavity of the stent body communicating with the outer side of the stent body through the filling channel.

[0007] Preferably, the support body contains one or more filling tubes; the inner diameter of the filling tube is 0.1-50 mm, and the length is 1-300 mm; the filling tube includes an inner layer and an outer layer fixedly connected to the inner layer; the material of the inner layer includes one or more of nickel-titanium alloy, cobalt-chromium alloy, cobalt-chromium-nickel alloy, and polymer materials, and the material of the outer layer includes one or more of PET, ePTFE, PTFE, and FEP; or the material of the outer layer includes one or more of nickel-titanium alloy, cobalt-chromium alloy, cobalt-chromium-nickel alloy, and polymer materials, and the material of the inner layer includes one or more of PET, ePTFE, PTFE, and FEP.

[0008] Preferably, one end of the filling tube is provided with a filling channel inlet end and the other end is provided with a filling channel outlet end, and the side wall of the support body is provided with a side wall opening adapted to the filling channel outlet end, and the filling channel outlet end is fixedly connected to the side wall of the support body.

[0009] Preferably, one end of the stent body is provided with a blood flow inlet end, and the filling channel inlet end faces away from the blood flow inlet end.

[0010] Preferably, a support fixing part is provided at the blood inlet end.

[0011] Preferably, a filling channel development mark is provided at the inlet end of the filling channel.

[0012] Preferably, the outlet end of the filling channel is provided with an opening and closing component adapted to the outlet end of the filling channel. The opening and closing component includes two or more elastic membranes, and the material of the elastic membranes includes one or more of PET, ePTFE, PTFE, and FEP.

[0013] Preferably, the outlet end of the filling channel is fixedly connected to the side wall of the support body by a suture; the filling tube is also provided with at least one filling tube fixing assembly, the filling tube fixing assembly includes a fixing ring disposed on the outside and / or inside of the filling tube and fixedly connected to the filling tube and a fixing line, the fixing ring being fixedly connected to the side wall of the support body through the fixing line; the material of the fixing ring includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy, and the material of the fixing line includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy.

[0014] Preferably, the stent body includes a stent main segment and one or more stent branch segments; the stent main segment and / or the stent branch segments include a membrane and a plurality of support frames fixedly connected to the membrane, the support frames being located inside and / or outside the membrane; the support frames include a wave-shaped annular metal wire and a connecting tube adapted to the metal wire, the first and last ends of the metal wire being fixedly connected through the connecting tube; the stent main segment and / or the stent branch segments are provided with stent imaging marks; the filling tube is disposed within the stent main segment and / or the stent branch segments; the stent main... The body segment and the branch segment of the support, as well as the support skeleton and the covering membrane, are all fixedly connected by sutures; the material of the covering membrane includes one or more of PET, ePTFE, PTFE, and FEP; the material of the metal wire includes one or more of nickel-titanium alloy, cobalt-chromium alloy, and cobalt-chromium-nickel alloy; the material of the connecting tube includes one or more of 316L stainless steel, nickel-titanium alloy, platinum-iridium alloy, platinum-tungsten alloy, and tan; and the material of the suture includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy.

[0015] Preferably, the filling tube is provided with a guidewire and / or microcatheter that is adapted to and removable from the filling channel.

[0016] A second aspect of the present invention provides a covered stent delivery system, the covered stent delivery system including the covered stent and a covered stent conveyor for delivering the covered stent.

[0017] A third aspect of the present invention provides an intravascular implantation assembly, the intravascular implantation assembly comprising the covered stent and the aneurysm cavity implant.

[0018] Preferably, the hemangioma cavity implant is adapted to the filling channel, and the hemangioma cavity implant includes one or more of spring coils, bio-adhesive, and liquid embolizing agents.

[0019] A fourth aspect of the present invention provides an intravascular implantable component delivery system, the intravascular implantable component delivery system including the intravascular implantable component and an implantable component delivery device for delivering the intravascular implantable component.

[0020] Compared with the prior art, the present invention has the following characteristics: (1) By reserving a filling channel inside the covered stent, after the covered stent is implanted, the filling channel can be used to transport the implant into the hemangioma cavity to fill the hemangioma cavity. This can effectively block the hemangioma and avoid problems such as displacement or poor wall adhesion of the covered stent, and leakage of the implant into the abdominal cavity. This reduces the difficulty of operation and surgical risk and improves safety.

[0021] (2) By setting up a filling tube, it is not only convenient for doctors to position the guide wire, but also avoids the high-pressure blood flow in the stent body from directly impacting the opening and closing components at the outlet end of the filling channel, which could lead to damage and tearing of the opening and closing components, displacement of the implant in the aneurysm cavity, etc., and effectively avoids the secondary "internal leakage" effect.

[0022] (3) By setting the inlet end of the filling channel to face away from the inlet end of the blood flow, the high-pressure blood flow flowing into the covered stent from the inlet end of the blood flow directly enters the hemangioma through the filling channel, which further reduces the risk of hemangioma rupture.

[0023] (4) An opening and closing component is provided at the outlet end of the filling channel, and the opening and closing component is in the form of an elastic membrane to form a structure similar to a "curtain". When the guide wire and / or microcatheter passes through, the outlet end of the filling channel is in an open state. When the guide wire and / or microcatheter is withdrawn, the outlet end of the filling channel closes naturally to block the implant that has been filled in the hemangioma cavity and prevent it from returning to the filling channel through the outlet end of the filling channel.

[0024] (5) The filling tube is fixedly connected to the side wall of the stent body by the filling tube fixing assembly, which avoids the high pressure blood flow in the covered stent from impacting the filling tube and causing the filling tube to move or shake, thereby affecting the positioning of the guide wire when the doctor operates and the smooth filling of the aneurysm cavity implant. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the front view of the covered scaffold in Example 1; Figure 2 This is a side view of the covered stent structure in Example 1; Figure 3 for Figure 2 A partially enlarged schematic diagram of the filling tube; Figure 4 This is a schematic diagram of the supporting skeleton in Example 1; Figure 5 This is a schematic diagram of the structure of the covered stent implanted in the hemangioma in Example 1; Explanation of markings in the diagram: 1—Stent body, 2—Filling tube, 3—Filling channel inlet end, 4—Filling channel outlet end, 5—Blood flow inlet end, 6—Stent fixation part, 7—Filling channel radiopaque marker, 8—Elastic membrane, 9—Fixation ring, 10—Fixation suture, 11—Stent body segment, 12—Stent branch segment, 13—Covering membrane, 14—Supporting skeleton, 15—Metal wire, 16—Connecting tube, 17—Stent radiopaque marker, 18—Guide wire, 19—Microcatheter, 20—Abdominal aorta, 21—Abdominal aortic aneurysm, 22—Right iliac artery, 23—Left iliac artery. Detailed Implementation

[0026] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. The following embodiments are based on the technical solution of the present invention and provide detailed implementation methods and specific operating procedures; however, the scope of protection of the present invention is not limited to the following embodiments.

[0027] It should be noted that the terminology used in this invention is for the purpose of describing specific embodiments only and is not intended to limit the invention.

[0028] In this invention, the singular forms “a,” “the,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0029] In this invention, the term "and / or" as used refers to any or all possible combinations of one or more associated listed items. The term "or" is generally used to include the meaning of "and / or" unless otherwise expressly stated in the content.

[0030] In this invention, unless otherwise stated, "multiple" means two or more (i.e., two or more), and "several" means that the quantity is not limited.

[0031] In this invention, although the terms first, second, third, etc., may be used to describe various features, these features should not be limited to these terms, which are only used to distinguish features of the same type from each other. For example, without departing from the scope of this invention, a first feature may also be referred to as a second feature, and similarly, a second feature may also be referred to as a first feature.

[0032] In this invention, the terms "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0033] In this invention, unless otherwise specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to mechanical or electrical connections, internal communication between two components, direct connections, or indirect connections via an intermediate medium. Those skilled in the art can understand the specific meaning of these terms according to the specific circumstances.

[0034] In this invention, the use of suffixes such as "module," "part," or "unit" to denote elements is merely for the purpose of illustrative purposes and has no specific meaning in itself. For example, "module" and "part" can be used interchangeably.

[0035] In this invention, for ease of description, terms such as "remote end" and "proximal end" may be used. "Remote end" refers to the side away from the equipment operator, and "proximal end" refers to the side closer to the equipment operator.

[0036] Furthermore, to avoid confusion with the present invention, some technical features known in the art have not been described.

[0037] This invention provides a film-coated scaffold, such as Figure 1 , Figure 2 As shown, the covered stent includes a stent body 1 and a filling tube 2 disposed within the stent body 1. The filling tube 2 has a filling channel, and the inner cavity of the stent body 1 is connected to the outer side of the stent body 1 through the filling channel. The filling tube 2 is pre-installed within the stent body 1, connecting the inner and outer sides of the stent body 1. When the covered stent is fully released within the blood vessel, the aneurysm implant can be delivered from the inner side of the stent body 1 through the filling channel into the aneurysm cavity to fill the aneurysm, without first maintaining the covered stent in a partially released state.

[0038] Preferably, the stent body 1 contains one or more filling tubes 2. The number and reasonable distribution of filling tubes 2 are determined according to the location, size, and number of hemangiomas.

[0039] Preferably, the inner diameter of the filling tube 2 is 0.1-50mm and the length is 1-300mm. The filling tube 2 must match the size of the stent body 1, and cannot be too thick or too long, while also ensuring that the implanted material in the aneurysm cavity can be smoothly delivered through the filling channel.

[0040] Preferably, the filling tube 2 includes an inner layer and an outer layer fixedly connected to the inner layer; the inner layer is made of one or more of the following materials: nickel-titanium alloy, cobalt-chromium alloy, cobalt-chromium-nickel alloy, and polymer materials; the outer layer is made of one or more of the following materials: PET (polyethylene terephthalate), ePTFE (expanded polytetrafluoroethylene), PTFE (polytetrafluoroethylene), and FEP (fluorinated ethylene propylene copolymer); or the outer layer is made of one or more of the following materials: nickel-titanium alloy, cobalt-chromium alloy, cobalt-chromium-nickel alloy, and polymer materials; the inner layer is made of one or more of the following materials: PET, ePTFE, PTFE, and FEP. The filling tube 2 is configured as a double-layer structure, one layer is used to form the filling channel, and the other layer is used to maintain the shape of the filling channel (e.g., to support the filling channel). The materials and functions of the inner and outer layers can be interchanged; the filling channel can be formed by the inner layer or by the outer layer.

[0041] Preferably, the filling tube 2 has a filling channel inlet end 3 at one end and a filling channel outlet end 4 at the other end. The side wall of the stent body 1 has a side wall opening adapted to the filling channel outlet end 4, and the filling channel outlet end 4 is fixedly connected to the side wall of the stent body 1. More preferably, the filling channel outlet end 4 is located on the side wall of the stent body 1 and has the same shape and size as the side wall opening of the stent body 1 (i.e., a perfect match). When delivering the hemangioma cavity implant, the hemangioma cavity implant enters the filling tube 2 through the filling channel inlet end 3, and then leaves the covered stent through the filling channel outlet end 4 and enters the hemangioma cavity.

[0042] Preferably, one end of the stent body 1 is provided with a blood flow inlet end 5, and the filling channel inlet end 3 faces away from the blood flow inlet end 5. Blood flow in the blood vessel enters the stent body 1 through the blood flow inlet end 5 and flows along the axial direction of the stent body 1. Since the filling channel inlet end 3 faces away from the blood flow inlet end 5, blood flow in the stent body 1 is prevented from flowing directly into the filling tube 2 through the filling channel inlet end 3.

[0043] Preferably, a stent fixation part 6 is provided at the blood inlet end 5. The stent fixation part 6 may adopt a barb or outward expansion structure, so that after the covered stent is implanted into the blood vessel, the stent fixation part 6 can maintain the position of the covered stent and prevent the covered stent from migrating in the long term.

[0044] Preferably, a filling channel imaging mark 7 is provided at the inlet end 3 of the filling channel. The filling channel imaging mark 7 can play a guiding role when filling the hemangioma cavity with implants.

[0045] Preferably, such as Figure 3 As shown, the outlet end 4 of the filling channel is provided with an opening and closing component adapted to the outlet end 4 of the filling channel. The opening and closing component includes two or more elastic membranes 8, and the elastic membranes 8 are made of one or more of PET, ePTFE, PTFE, and FEP. The two or more elastic membranes 8 can be spliced ​​together to cooperate with each other, so that the outlet end 4 of the filling channel can be naturally closed when no force is applied, and the outlet end 4 of the filling channel can be opened when force is applied to facilitate the filling of the hemangioma cavity implant.

[0046] Preferably, the outlet end 4 of the filling channel is fixedly connected to the side wall of the support body 1 by a suture; the filling tube 2 is also provided with at least one filling tube fixing assembly, which includes a fixing ring 9 disposed on the outside and / or inside of the filling tube 2 and fixedly connected to the filling tube 2, and a fixing line 10. The fixing ring 9 is fixedly connected to the side wall of the support body 1 through the fixing line 10. The filling tube 2 is fixedly connected to the support body 1 near its end, and the filling tube fixing assembly is added at other positions of the filling tube 2 to further fix it to the support body 1, forming a multi-point fixing method to ensure that the connection of the filling tube 2 is stable.

[0047] Preferably, the material of the fixing ring 9 includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy, and the material of the fixing wire 10 includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy.

[0048] Preferably, the stent body 1 includes a stent main segment 11 and one or more stent branch segments 12. The stent body 1 may consist only of the stent main segment 11 (i.e., the number of stent branch segments 12 is 0), or it may have one, two or more stent branch segments 12 on the stent main segment 11. The lengths of different stent branch segments 12 may be equal or unequal, for example, they may be long-leg branches and short-leg branches respectively.

[0049] Preferably, the main body segment 11 and / or the branch segment 12 of the stent include a membrane 13 and a plurality of support frames 14 fixedly connected to the membrane 13, the support frames 14 being located inside and / or outside the membrane 13. The filling tube 2 is preferably fixedly connected to the membrane 13.

[0050] Preferably, such as Figure 4 As shown, the support frame 14 includes a metal wire 15 arranged in a wave-like loop and a connecting pipe 16 adapted to the metal wire 15. The first and last ends of the metal wire 15 are fixedly connected through the connecting pipe 16.

[0051] Preferably, the stent body section 11 and / or stent branch section 12 are provided with stent imaging marks 17. The stent imaging marks 17 can serve as guides and for docking and positioning.

[0052] Preferably, the filling tube 2 is disposed within the main body section 11 and / or the branch section 12 of the stent. The filling tube 2 may be disposed only within the main body section 11 or the branch section 12 of the stent, or the required number of filling tubes 2 may be disposed in the main body section 11 and the multiple branch sections 12 of the stent respectively.

[0053] Preferably, the main body segment 11 and the branch segment 12 of the support, as well as the support frame 14 and the covering membrane 13, are fixedly connected by sutures.

[0054] Preferably, the material of the coating 13 includes one or more of PET, ePTFE, PTFE, and FEP; the material of the metal wire 15 includes one or more of nickel-titanium alloy, cobalt-chromium alloy, and cobalt-chromium-nickel alloy; the material of the connecting tube 16 includes one or more of 316L stainless steel, nickel-titanium alloy, platinum-iridium alloy, platinum-tungsten alloy, and tan; and the material of the suture includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy.

[0055] Preferably, such as Figure 5 As shown, the filling tube 2 is provided with a removable guidewire 18 and / or microcatheter 19 adapted to the filling channel. At least one of the guidewire 18 or microcatheter 19 can be pre-inserted in the covered stent to facilitate rapid positioning and filling of the aneurysm cavity implant after the covered stent is fully released.

[0056] The present invention also provides a covered stent delivery system, which includes the aforementioned covered stent and a covered stent delivery device for delivering the covered stent. The covered stent can be pre-assembled in the covered stent delivery device to form the covered stent delivery system. In use, the covered stent is delivered to the aneurysm via the covered stent delivery device and then released.

[0057] The present invention also provides an intravascular implantation assembly, which includes the aforementioned covered stent and aneurysm cavity implant. The covered stent and the aneurysm cavity implant can be combined and used together. In use, the covered stent is first delivered to the aneurysm and released, and then the aneurysm cavity implant is delivered into the aneurysm cavity for filling through the filling channel on the covered stent.

[0058] Preferably, the hemangioma cavity implant is adapted to the filling channel, and the hemangioma cavity implant includes one or more of coils, bio-adhesive, and liquid embolizing agents. Various common types of hemangioma cavity implants can be used, as long as they can be delivered through the filling channel.

[0059] The present invention further provides an intravascular implantable component delivery system, which includes the aforementioned intravascular implantable component and an implantable component delivery device for delivering the intravascular implantable component. The implantable component delivery device can be of an integral structure, or of a split or combined structure, to deliver covered stents and aneurysm cavity implants respectively.

[0060] This invention pre-designs one or more filling tubes 2 inside the covered stent to fill the hemangioma cavity with implanted material after the covered stent is implanted. This solves the problems of stent displacement and poor stent adhesion to the blood vessel wall caused by filling the hemangioma cavity with implanted material first and then completely releasing the covered stent, as well as the risk of implanted material being left in the abdominal cavity when directly puncturing the hemangioma cavity from outside the patient and injecting the implanted material to fill the hemangioma.

[0061] Example 1:

[0062] Currently, the incidence of aneurysms remains high, with a mortality rate as high as 90%. Conventional surgical treatment involves significant trauma, which is extremely detrimental to patient recovery. With the development of endovascular repair techniques, new methods have emerged for aneurysm treatment, with covered stent grafting being the current mainstream technique. In this procedure, the stent is made of nickel-titanium alloy wire or other metal materials, and its surface is sutured with a polymer membrane. The entire covered stent is installed within a delivery catheter. During the procedure, an artery is first punctured, then the covered stent is delivered to the aneurysm site under guidance, and finally released. The length of the covered stent completely covers the length of the aneurysm. Because of the polymer membrane on the stent, arterial blood flow is blocked, preventing blood from impacting the aneurysm wall and forming a closed cavity, allowing for arterial remodeling and achieving the therapeutic goal. However, in covered stent grafting, approximately 35% of cases experience a "leakage" effect due to ineffective aneurysm closure, leading to aneurysm recurrence.

[0063] Based on this, this embodiment provides a coated stent with a pre-filled function. For example... Figure 1 , Figure 2 As shown, the stent body 1 includes a main stent segment 11 and two branch stent segments 12 (a long-leg branch and a short-leg branch, respectively). Both the main stent segment 11 and the branch stent segments 12 include multiple support frames 14, and a polymer film 13 is applied to the outer or inner surface of each support frame 14. The support frames 14 and the film 13 are fixed together by sutures. The main stent segment 11 and the branch stent segments 12 are also fixed together by sutures between the film 13. The film 13 can be made of PET, ePTFE, PTFE, or FEP, etc., and the sutures can be made of PET, ePTFE, PTFE, FEP, etc. Figure 4As shown, the support frame 14 is formed by weaving and heat treatment, and is connected to the metal wire 15 by the connecting pipe 16 and fixed by welding. The metal wire 15 can be made of nickel-titanium alloy, cobalt-chromium alloy, cobalt-chromium-nickel alloy, etc., and the connecting pipe 16 can be made of 316L stainless steel, nickel-titanium alloy, platinum-iridium alloy, platinum-dip alloy, tank steel, etc.

[0064] The stent body 1 contains a filling tube 2, which has a filling channel. One end of the filling channel is fixed to the stent body 1, and the opening of the other end faces the same direction as the opening of the short-leg branch. The filling tube 2 has a filling channel imaging mark 7, which acts as an imaging marker during the filling process after the covered stent is implanted, facilitating the guidance of the guide wire 18 into the filling channel. The short-leg branch has a stent imaging mark 17, which serves as a guide and docking positioning marker when a single covered stent is implanted again.

[0065] The filling tube 2 adopts a double-layer structure. One layer can be a metal braided structure, made of materials such as nickel-titanium alloy, cobalt-chromium alloy, or cobalt-chromium-nickel alloy; it can also be made of a metal-free, single-material polymer. The other layer is made of a polymer material, such as PET, ePTFE, PTFE, or FEP. The inner diameter of the filling tube 2 ranges from 0.1 to 50 mm, and the length ranges from 1 to 300 mm. The placement of the filling tube 2, besides... Figure 1 It can be set in the short leg branch as in the example, or it can be set in the long leg branch, or in the main body section 11 of the support. Multiple filling tubes 2 can also be set in one covered support, that is, the number of filling tubes 2 is ≥1.

[0066] like Figure 3 As shown, the outlet end 4 of the filling channel is provided with two elastic membranes 8, forming an opening and closing assembly. The elastic membranes 8 can be made of polymer materials, such as PET, ePTFE, PTFE, FEP, etc. The outlet end 4 of the filling channel is circumferentially sutured to the covering membrane 13. The sutures can be made of polymer materials or metals (such as platinum-iridium alloy, platinum-dipole alloy, etc.). An openable slit is formed between the two elastic membranes 8. When the guidewire 18 and microcatheter 19 pass through, the slit becomes open; when the guidewire 18 and microcatheter 19 are retracted, the slit closes naturally, forming a "curtain" effect. The number of elastic membranes 8 can also be greater to form multiple slits. In this embodiment, the setting of the filling channel not only facilitates the doctor's operation of the guidewire 18 for positioning, but also protects the opening and closing assembly, avoiding problems such as tearing of the elastic membranes 8 of the opening and closing assembly due to the high blood flow pressure in the covered stent cavity, and displacement of the implant in the aneurysm cavity.

[0067] Figure 3In the stent, the filling tube 2 is also equipped with a filling tube fixation assembly, which includes a fixation ring 9 and a fixation wire 10, serving to further fix the filling tube 2 to the short-leg branch. The fixation ring 9 circumferentially surrounds the outside of the filling tube 2, and there are at least one fixation ring 9. It is then fixed to the covering 13 by the fixation wire 10. The function of the filling tube fixation assembly is to prevent the filling tube 2 from shaking due to the high blood flow velocity within the covered stent lumen, thus providing a fixation effect. Without the filling tube fixation assembly, the filling tube 2 would shake and deflect under the impact of blood flow, making it difficult for the doctor to position the guidewire 18. The fixation ring 9 and the fixation wire 10 can be made of materials such as PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, or platinum-dip alloy.

[0068] like Figure 5 As shown, an abdominal aortic aneurysm 21 is formed at the junction of the abdominal aorta 20 with the right iliac artery 22 and the left iliac artery 23. After the covered stent reaches the abdominal aortic aneurysm 21 via the covered stent delivery device, the covered stent is released, allowing the covering 13 of the covered stent to completely cover the entire abdominal aortic aneurysm 21. When it is necessary to fill the abdominal aortic aneurysm 21, the guidewire 18 is guided into the filling channel through the contrast marker 7 until the distal end of the guidewire 18 extends into the aneurysm cavity of the abdominal aortic aneurysm 21; then, the microcatheter 19, guided by the guidewire 18, enters the aneurysm cavity through the filling channel; then the guidewire 18 is withdrawn, and the internal channel of the microcatheter 19 is used to deliver implants such as coils, bio-adhesive, and liquid embolizing agents into the aneurysm cavity. The guidewire 18 and / or the microcatheter 19 can also be pre-assembled within the covered stent, and can be directly used to fill the aneurysm cavity after the covered stent is released into the blood vessel.

[0069] In this embodiment, the covered stent can be implanted into the patient's blood vessel first. After the hemangioma is completely blocked, the filling channel reserved in the covered stent is used to deliver the hemangioma cavity implant for filling the hemangioma, which simplifies the surgical procedure and reduces patient suffering.

[0070] Example 2:

[0071] A covered stent delivery system includes the covered stent as described in Example 1 and a covered stent conveyor for delivering the covered stent.

[0072] Example 3:

[0073] An intravascular implantable component includes the covered stent of Example 1 and an aneurysm cavity implant. The aneurysm cavity implant is adapted to the filling channel and is made of coils, bio-adhesive, or a liquid embolizing agent.

[0074] Example 4:

[0075] An intravascular implantable component delivery system includes the intravascular implantable component as described in Example 3 and an implantable component delivery device for delivering the intravascular implantable component.

[0076] The above description of the embodiments is provided to enable those skilled in the art to understand and use the invention. It will be apparent to those skilled in the art that various modifications can be made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present invention is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present invention without departing from the scope of the invention should be within the protection scope of the present invention.

Claims

1. A covered stent, characterized in that, The covered stent includes a stent body (1) and a filling tube (2) disposed in the stent body (1). The filling tube (2) is provided with a filling channel, and the inner cavity of the stent body (1) is connected to the outer side of the stent body (1) through the filling channel.

2. The covered stent according to claim 1, characterized in that, The support body (1) is provided with one or more filling tubes (2); The inner diameter of the filling tube (2) is 0.1-50mm, and the length is 1-300mm; The filling tube (2) includes an inner layer and an outer layer fixedly connected to the inner layer; The inner layer is made of one or more of nickel-titanium alloy, cobalt-chromium alloy, cobalt-chromium-nickel alloy, and polymer materials, and the outer layer is made of one or more of PET, ePTFE, PTFE, and FEP; or the outer layer is made of one or more of nickel-titanium alloy, cobalt-chromium alloy, cobalt-chromium-nickel alloy, and polymer materials, and the inner layer is made of one or more of PET, ePTFE, PTFE, and FEP.

3. The covered stent according to claim 1, characterized in that, One end of the filling tube (2) is provided with a filling channel inlet end (3) and the other end is provided with a filling channel outlet end (4). The side wall of the support body (1) is provided with a side wall opening that is adapted to the filling channel outlet end (4). The filling channel outlet end (4) is fixedly connected to the side wall of the support body (1).

4. A covered stent according to claim 3, characterized in that, One end of the stent body (1) is provided with a blood flow inlet end (5), and the filling channel inlet end (3) faces away from the blood flow inlet end (5).

5. A covered stent according to claim 4, characterized in that, A bracket fixing part (6) is provided at the blood inlet end (5).

6. A covered stent according to claim 3, characterized in that, A filling channel development mark (7) is provided at the inlet end (3) of the filling channel.

7. A covered stent according to claim 3, characterized in that, The filling channel outlet end (4) is provided with an opening and closing component adapted to the filling channel outlet end (4). The opening and closing component includes two or more elastic membranes (8). The material of the elastic membranes (8) includes one or more of PET, ePTFE, PTFE, and FEP.

8. A covered stent according to claim 3, characterized in that, The filling channel outlet end (4) is fixedly connected to the side wall of the support body (1) by a suture; The filling tube (2) is also provided with at least one filling tube fixing assembly. The filling tube fixing assembly includes a fixing ring (9) disposed on the outside and / or inside of the filling tube (2) and fixedly connected to the filling tube (2) and a fixing line (10). The fixing ring (9) is fixedly connected to the side wall of the support body (1) through the fixing line (10). The material of the fixing ring (9) includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy, and the material of the fixing wire (10) includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy.

9. A covered stent according to claim 1 or 8, characterized in that, The stent body (1) includes a stent main body segment (11) and more than 0 stent branch segments (12). The main body segment (11) and / or the branch segment (12) of the stent include a membrane (13) and a plurality of support frames (14) fixedly connected to the membrane (13), the support frames (14) being located inside and / or outside the membrane (13); The support frame (14) includes a metal wire (15) arranged in a wave-shaped loop and a connecting tube (16) adapted to the metal wire (15). The first and last ends of the metal wire (15) are fixedly connected through the connecting tube (16). The main body segment (11) and / or the branch segment (12) of the stent are provided with stent imaging marks (17). The filling tube (2) is disposed within the main body section (11) and / or the branch section (12) of the support; The main body segment (11) of the support and the branch segment (12) of the support, as well as the support frame (14) and the covering membrane (13), are all fixedly connected by sutures; The material of the coating (13) includes one or more of PET, ePTFE, PTFE, and FEP; the material of the metal wire (15) includes one or more of nickel-titanium alloy, cobalt-chromium alloy, and cobalt-chromium-nickel alloy; the material of the connecting tube (16) includes one or more of 316L stainless steel, nickel-titanium alloy, platinum-iridium alloy, platinum-tungsten alloy, and tan; and the material of the suture includes one or more of PET, ePTFE, PTFE, FEP, nickel-titanium alloy, platinum-iridium alloy, cobalt-chromium-nickel alloy, and platinum-tungsten alloy.

10. A covered stent according to claim 1, characterized in that, The filling tube (2) is provided with a guide wire (18) and / or a microcatheter (19) that are adapted to and removable from the filling channel.

11. A film-coated stent delivery system, characterized in that, The covered stent delivery system includes a covered stent as described in any one of claims 1 to 10 and a covered stent delivery device for delivering the covered stent.

12. An intravascular implantable component, characterized in that, The intravascular implantation assembly includes a covered stent as described in any one of claims 1 to 10 and a hemangioma cavity implant.

13. An intravascular implantable component according to claim 12, characterized in that, The hemangioma cavity implant is adapted to the filling channel, and the hemangioma cavity implant includes one or more of spring coils, bio-adhesive, and liquid embolizing agents.

14. An intravascular implantable component delivery system, characterized in that, The intravascular implantable component delivery system includes the intravascular implantable component as described in claim 12 or 13 and an implantable component delivery device for delivering the intravascular implantable component.

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