A covered stent

Abstract

The application belongs to the technical field of medical devices, and particularly relates to a covered stent, which comprises a main support member and a covered body arranged on the main support member, wherein the main support member comprises a main stent section and a support stent section arranged at the proximal end of the main stent section, the support stent section comprises a connecting wave coil connected with the covered body, and the connecting wave coil comprises a plurality of fixed wave segments fixedly connected with the covered body and at least one active wave segment movably connected with the covered body. According to the covered stent in the application, the problem that the inner membrane of the aorta is easily damaged by the bare stent or barbs of the traditional covered stent can be avoided, the inner wall of the blood vessel in the anchoring area of the patient is protected, and the adhesion effect is better.

Description

Technical Field

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

[0002] Aortic aneurysm and aortic dissection are serious diseases that threaten human life. If left untreated, the aortic aneurysm and dissection will continue to grow and eventually rupture, causing serious complications and death. With the increasing number of patients with hypertension, hyperlipidemia and diabetes, the incidence of aortic aneurysm and aortic dissection is also increasing significantly.

[0003] Traditional open surgery for aortic aneurysms and aortic dissections is highly invasive, has a high mortality rate, long operation time, high postoperative complication rate, and is very difficult. Endovascular treatment, on the other hand, is less invasive, has fewer postoperative complications, shorter operation time, and is less difficult, and has gradually become the main method for treating aortic aneurysms and aortic dissections. By implanting a covered stent in the aorta, the vascular lesion is isolated outside the covered stent, restricting blood flow through the stent and thus protecting the blood vessel.

[0004] Traditional aortic endovascular stent grafts typically expose a bare stent made of shape memory alloy at the proximal end of the stent (the side closest to the heart after stent graft deployment), or have barbs on the outer wall of the stent, so that the endovascular stent graft can be accurately placed in the artery during surgery and in the early postoperative period, and to ensure that the endovascular stent graft does not retract.

[0005] However, the bare stent and barbs used in this method remain in the artery indefinitely, which over time can cause damage to the patient's artery, leading to rupture of the aortic intima and media, and the formation of new aortic dissections. Furthermore, when the dissection progresses retrogradely, the intima in the anchoring zone becomes fragile, and the above method may damage the intima during stent deployment, causing intimal rupture and creating new tears. Therefore, a new technical solution is needed to address these problems. Summary of the Invention

[0006] The purpose of this invention is to at least solve the problem that the aortic intima is easily damaged by bare stents or barbs of covered stents.

[0007] One aspect of the present invention provides a film-coated support, comprising a main support member and a film-coated body disposed on the main support member, wherein the main support member includes a main support segment and a support frame segment disposed near the proximal end of the main support segment, the support frame segment includes a connecting wave loop connected to the film-coated body, the connecting wave loop includes a plurality of fixed waveform segments fixedly connected to the film-coated body and at least one movable waveform segment movably connected to the film-coated body.

[0008] In the covered stent of the present invention, the fixed waveform segments are fixed to the covered body to provide the main support, and the movable waveform coil is movably connected to the covered body for connecting the stent release device. Thus, by replacing the traditional bare stent waveform coil with the connecting waveform coil, the problem of easy damage to the aortic intima by the bare stent or barbs of traditional covered stents can be avoided, protecting the vascular wall in the patient's anchoring zone and achieving better apposition.

[0009] In some embodiments of the present invention, the fixed waveform segments and the active waveform segments are arranged alternately.

[0010] In some embodiments of the present invention, the proximal end of the fixed waveform segment is flush with the proximal edge of the coating body, or is closer to the distal end of the coating body than the proximal edge of the coating body.

[0011] In some embodiments of the present invention, the fixed waveform segmentation includes fixed peaks, fixed troughs, and fixed wave bars connecting adjacent fixed peaks and fixed troughs. The top of the fixed peak is flush with the proximal edge of the coating body, or is closer to the distal end of the coating body than the proximal edge of the coating body.

[0012] The active waveform segment includes active peaks, active troughs, and active wave bars connecting adjacent active peaks and active troughs. The active troughs are fixedly connected to the coating body, while the active peaks and active wave bars are movably connected to the coating body.

[0013] In some embodiments of the present invention, the movable wave rod is set at a preset angle to the coating body; or the movable wave rod includes a bent portion connected to the movable wave crest, and the bent portion is set at a preset angle to the coating body.

[0014] In some embodiments of the present invention, the movable wave rod is bent toward the inside of the coating body, or the bent portion is bent toward the inside of the coating body, the preset angle is greater than 0° and less than or equal to 45°, and the percentage of the ratio of the length of the bent portion to the length of the movable wave rod is greater than or equal to 10% and less than or equal to 60%.

[0015] In some embodiments of the present invention, the support frame section further includes a support wavering disposed at the support coating port, wherein the wire diameter of the support wavering is smaller than the wire diameter of the connecting wavering.

[0016] In some embodiments of the present invention, the number of bands of the supporting waveband is greater than the number of bands of the connecting waveband.

[0017] In some embodiments of the present invention, the supporting wave ring is fixedly connected to the film body, or the supporting wave ring is fixedly connected to the connecting wave ring.

[0018] In some embodiments of the present invention, the proximal end of the support wavering is flush with the proximal edge of the coating body, or the distal end of the support wavering is flush with the distal edge of the connecting wavering, or the support wavering is disposed between the distal end of the connecting wavering and the proximal end of the coating body.

[0019] In some embodiments of the present invention, the main support member is provided with a recessed portion facing inward to the main support member, the recessed portion including a recessed support member connected to the main support member and a recessed film disposed on the recessed support member; a developing element is disposed on the main support member and / or the support film. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the overall structure of the film-coated stent in Embodiment 1 of the present invention;

[0021] Figure 2 This is a schematic diagram of the branch support structure in Embodiment 1 of the present invention.

[0022] Figure 3 This is a schematic diagram of the proximal portion of the covered stent in Embodiment 1 of the present invention;

[0023] Figure 4 This is a schematic diagram of another embodiment of the proximal portion of the covered stent in Embodiment 1 of the present invention;

[0024] Figure 5 This is a schematic diagram of the main support waveguide in Embodiment 1 of the present invention;

[0025] Figure 6 This is a schematic diagram of the structure connecting the waveguide in Embodiment 1 of the present invention;

[0026] Figure 7 This is a schematic diagram of the connection structure between the waveguide and the coating body in Embodiment 1 of the present invention;

[0027] Figure 8 This is a schematic diagram of the supporting wave coil structure in Embodiment 1 of the present invention;

[0028] Figure 9 This is a schematic diagram of the structure of the covered stent in the semi-released state in Embodiment 1 of the present invention;

[0029] Figure 10 This is a schematic diagram of the connection structure between the conveying device and the film-coated support when the film-coated support is in a semi-released state in Embodiment 1 of the present invention;

[0030] Figure 11 This is a schematic diagram of another embodiment of the main support wave coil in Embodiment 1 of the present invention;

[0031] Figure 12 This is a schematic diagram of the structure of the film-coated stent inside the sheath in Embodiment 1 of the present invention;

[0032] Figure 13 This is a cross-sectional view of the membrane-covered stent inside the sheath in Embodiment 1 of the present invention;

[0033] Figure 14 This is a schematic diagram of the structure in Embodiment 1 of the present invention, in which the connecting waveband and the supporting waveband are set to differ by half a phase.

[0034] Figure 15 This is a schematic diagram of the developing strip in Embodiment 1 of the present invention;

[0035] Figure 16 This is a schematic diagram of the developing strip from another perspective in Embodiment 1 of the present invention;

[0036] Figure 17 This is a schematic diagram of the connecting rod in Embodiment 2 of the present invention;

[0037] Figure 18 This is a side view of the connecting waveguide in Embodiment 3 of the present invention;

[0038] Figure 19 This is a front view of the connecting waveguide in Embodiment 3 of the present invention;

[0039] Figure 20 This is a side view of the connecting waveguide in Embodiment 4 of the present invention;

[0040] Figure 21 This is a front view of the connecting waveguide in Embodiment 4 of the present invention;

[0041] Figure 22 This is a schematic diagram of the proximal portion of the covered stent in Embodiment 5 of the present invention;

[0042] Figure 23 This is a schematic diagram of the proximal portion of the covered stent in Embodiment Six of the present invention;

[0043] Figure 24 This is a schematic diagram of the proximal portion of the covered stent in Embodiment 7 of the present invention;

[0044] Figure 25 This is a schematic diagram of the proximal portion of the covered stent in Embodiment 8 of the present invention;

[0045] Figure 26 This is a schematic diagram of the developing element of the coating support in Embodiment 9 of the present invention;

[0046] Figure 27 This is a schematic diagram of the developing element of the coating support in Embodiment 9 of the present invention from another perspective.

[0047] The labels in the attached diagram are as follows:

[0048] 001, Coating support; 002, Main support; 003, Branch support; 100, Main support component; 200, Main support section; 300, Support frame section; 400, Branch support component; 401, Branch waveguide; 402, Branch connecting rod; 403, Development ring; 500, Branch coating;

[0049] 10. Coated body; 11. Developing element; 111. First developing point; 112. Second developing point; 113. Third developing point; 114. Fourth developing point; 115. Fifth developing point; 116. Sixth developing point; 117. Seventh developing point; 118. Eighth developing point; 119. Developing bar; 20. Main support waveguide; 21. Main support peak; 22. Main support connecting rod; 23. Main support trough; 24. Connecting rod; 30. Connecting waveguide; 301. Connecting wave section; 31. Movable waveform segment; 311. Movable peak; 312. Movable wave rod; 313. Movable... 314. Valley; 315. Bending section; 316. Movable distal end; 317. Movable proximal end; 32. Fixed waveform segment; 321. Fixed wave crest; 322. Fixed wave rod; 323. Fixed valley; 33. Stitching point; 40. Supporting wave ring; 41. Supporting waveform segment; 42. Supporting unit; 50. Groove section; 51. Groove support; 52. Groove covering; 521. Through hole; 53. Stitching ring; 54. Groove support frame; 541. Groove support section; 542. Mesh; 60. Release mechanism; 61. Sheath tube; 62. Sheath core; 63. Claw; 64. Guide section. Detailed Implementation

[0050] Exemplary embodiments of the invention will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the invention are shown in the drawings, it should be understood that the invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the invention and to fully convey the scope of the invention to those skilled in the art.

[0051] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0052] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0053] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0054] For ease of description, the following description uses the terms "distal" and "proximal," where "distal" refers to the end furthest from the heart and "proximal" refers to the end closest to the heart. The phrase "axial direction" should be understood in this patent as indicating the direction in which the interventional device is advanced and de-escalated. The direction perpendicular to the "axial direction" is defined as the "radial direction."

[0055] Example 1, as Figures 1 to 3 As shown, the covered stent 001 of this embodiment has a hollow tubular structure with openings at both ends, including a main stent 002 and a branch stent 003. The branch stent 003 is disposed inside the main stent 002. The main stent 002 is used for implantation into the aorta, and the branch stent 003 is used for implantation into a branch vessel. The branch stent 003 has a hollow cylindrical structure and is arranged along the length of the main stent 002. The main stent 002 includes a main support member 100 and a covered body 10. The branch stent 003 and the main support member 100 have the same axial direction.

[0056] In other embodiments, the branch bracket 003 is set at a preset angle to the main support member 100. The preset angle can be 3°, 5° or 10°, etc., and can be set according to actual needs.

[0057] The surface of the main support 002 is provided with a recessed portion 50 facing inward towards the main support 002. The edge of the recessed portion 50 is connected to the film-coated body 10 of the main support 002. The recessed portion 50 includes a recessed support member 51 and a recessed film 52 disposed on the recessed support member 51. The recessed support member 51 is connected to the main support member 100, and the recessed film 52 is connected to the film-coated body 10.

[0058] In this embodiment, the edge of the grooved film 52 is connected to the film body 10 by stitching. Specifically, a stitching ring 53 is provided between the grooved film 52 and the film body 10, and the grooved film 52 and the film body are connected by the stitching ring 53. A support ring (not shown in the figure) for reinforcing the support strength of the groove portion 50 may be provided inside the stitching ring 53. The support ring is an elastic metal ring.

[0059] In other embodiments, the grooved film 52 can also be integrally formed with the film body 10, and the grooved film 52 is fixed to the grooved support member 51 by means of sewing or other methods. The grooved support member 51 is recessed relative to the main support member 100, and the grooved support member 51 is used to shape the grooved film 52, thereby forming an integrally recessed groove portion 50.

[0060] The grooved membrane 52 has a through hole 521, and the branch stent 003 communicates with the through hole 521, allowing blood to flow from the main stent 002 through the through hole 521 into the branch stent 003. The branch stent 003 is fixedly connected to the through hole 521 by suturing. The main stent 002 includes one or more branch stents 003, and the diameters of the multiple branch stents 003 can be the same or different, depending on the actual needs.

[0061] In this embodiment, the covered stent 001 includes three branch stents 003, wherein two branch stents 003 are disposed near the proximal end of the groove portion 50, and one branch stent 003 is disposed near the distal end of the groove portion 50.

[0062] The branch support 003 includes a branch support 400 and a branch coating 500 disposed on the branch support 400. The branch coating 500 is connected to the through hole 521 by stitching. A imaging ring 403 is stitched to the outer edge of the through hole 521 via suture lines to indicate the position of the branch support 003. The branch support 400 includes a plurality of spaced-apart branch wave coils 401, with branch connecting rods 402 disposed between adjacent branch wave coils 401. The branch wave coils 401 are wavy or diamond-shaped.

[0063] The coating body 10 is disposed on the main support member 100. It should be understood that the main support member 100 can be disposed on the inner surface of the coating body 10 or on the outer surface of the coating body 10, or a portion of the main support member 100 can be disposed on the inner surface of the coating body 10 and another portion of the main support member 100 can be disposed on the outer surface of the coating body 10.

[0064] In this embodiment, the length of the covered body 10 is greater than or equal to the length of the main support member 100, so that the covered body 10 completely covers the main support member 100, that is, the main support member 100 does not have a bare stent portion, thereby avoiding damage to the inner wall of the blood vessel caused by the main support member 100 after the covered stent 001 is implanted into the blood vessel, and avoiding significant stimulation of the inner wall of the blood vessel caused by the main support member 100.

[0065] In other embodiments, the main support 100 may also extend partially beyond the covering body 10, and the portion of the main support 100 extending beyond the covering body 10 may be bent toward the central axis of the covering stent 001, so that the portion of the main support 100 extending beyond the covering body 10 will not come into contact with the inner wall of the blood vessel after the covering stent 001 is implanted into the blood vessel, thereby avoiding the main support 100 from causing significant irritation to the inner wall of the blood vessel.

[0066] The groove 50 is formed on the film body 10 and is located in the middle of the main film 10. The groove 50 forms a roughly rectangular shape on the film body 10, that is, when the film body 10 is unfolded, it has a rectangular window.

[0067] The covered stent 001 also includes a grooved support frame 54, which is disposed on the outside of the grooved covered stent 52 and protrudes from the surface of the covered stent body 10 towards the outside of the grooved covered stent 52. The grooved support frame 54 is fixed to the edge of the groove portion 50 by suturing, and when the covered stent 001 is implanted into the aortic arch, the grooved support frame 54 can support the inner wall of the aortic vessel, thereby providing better fixation.

[0068] Specifically, the grooved support frame 54 includes multiple grooved support segments 541, which are connected to the edge of the groove portion 50. These segments are also interconnected by hooking each other, forming a mesh structure with openings 542. That is, the vertices of adjacent grooved support segments 541 are connected by interlocking, preventing the grooved support frame 54 from detaching when the film-coated bracket 001 deforms. Simultaneously, the size of the mesh openings 542 formed by adjacent grooved support segments 541 can change under external force, thereby enhancing the elasticity of the grooved support frame 54 and improving its adhesion to the wall.

[0069] In other embodiments, the groove support frame 54 can also be integrally formed with the main support frame 002, and the groove support frame 54 is wavy, which can reduce costs while satisfying the support function of the groove support frame 54.

[0070] The main support component 100 includes a main support section 200 and a support frame section 300 disposed near the main support section 200. The support frame section 300 includes a connecting wave ring 30 and a supporting wave ring 40. The connecting wave ring 30 is partially connected to the film-coated body 10 and is used to connect the release mechanism of the film-coated support 001. The supporting wave ring 40 is disposed at the port of the film-coated body 10 and is used to support the port of the film-coated body 10.

[0071] The main support component 100 is made of a material with good biocompatibility and elasticity, such as nickel-titanium alloy or stainless steel. The coating body 10 is made of a thin film material with good biocompatibility, such as PET or PTFE. The coating body 10 can be a single-layer structure or a multi-layer structure.

[0072] like Figures 3 to 5 As shown, the main support section 200 includes several main support coils 20. The main support coil 20 has a Z-shaped coil structure. The Z-shaped coil structure is formed by connecting multiple sub-coils end to end to form a closed loop structure with peaks and troughs.

[0073] Specifically, the main support corrugation 20 includes a main support crest 21, a main support trough 23, and a main support connecting rod 22 connecting the main support crest 21 and the main support trough 23. Several main support corrugations 20 are spaced apart, and the main support corrugations 20 are connected and fixed to the film-coating body 10. The main support corrugations 20 are connected only through the film-coating body 10, and the main support corrugations 20 and the film-coating body 10 are fixed by stitching or adhesive bonding, the method of fixing being selected according to actual needs.

[0074] In this embodiment, the main stent peak 21 of a main stent wave loop 20 is correspondingly set with the main stent trough 23 of the adjacent main stent wave loop 20, and correspondingly, the main stent trough 23 of a main stent wave loop 20 is correspondingly set with the main stent peak 21 of the adjacent main stent wave loop. This ensures that the covered stent 001 has better compliance when implanted at the corresponding position in the aortic arch.

[0075] The main stent segment 200 has a variable diameter structure, with the diameter of its distal end being smaller than that of its proximal end. Specifically, the diameter of the main stent coil 20 located at the distal end of the main stent segment 200 is smaller than that located at the proximal end. This allows for better adaptation to the shape of the aorta, enabling the covered stent 001 to better conform to the inner wall of the aorta.

[0076] In other embodiments, when the covered stent 001 is applicable to other aortic vessel sites, the main stent segment 200 may also be a cylindrical hollow tube with the same diameter everywhere.

[0077] In this embodiment, the coating body 10 is attached to the main support member 100 and can change shape with the main support member 100. The main support member 100 is used to expand the coating body 10 when the coating bracket 001 is released. Each main bracket corrugated ring 20 is a wavy metal ring, so that after the coating bracket 001 is released, the coating body 10 has a hollow cylindrical structure. Each main bracket corrugated ring 20 has the same diameter, or different diameters can be used depending on actual needs.

[0078] The coating body 10 has open ends and a closed tubular structure in the middle. The coating body 10 can be a single layer or multiple layers of membrane. When the coating body uses a multi-layer membrane structure, adjacent layers can be fixed together by adhesive bonding, direct firing, or heat treatment. The materials of adjacent layers can be the same or different.

[0079] The main support coil 20, connecting coil 30, and support coil 40 are all made of shape memory alloy. For example, the main support coil 20, connecting coil 30, and support coil 40 are all formed by braiding nickel-titanium alloy wire or cutting and shaping nickel-titanium tubes. Nickel-titanium alloy has good fatigue life and strong corrosion resistance. Furthermore, by using shape memory alloy material to make the main support component 100, the main support component 100 can recover to a preset shape at a preset temperature, such as 36°C. The preset shape can be set according to actual needs, and this application does not limit it.

[0080] The connecting corrugated ring 30 can be disposed on the inner side of the coating body 10, and the supporting corrugated ring 40 can be disposed on the inner or outer side of the coating body 10, depending on actual needs. When the supporting corrugated ring 40 is disposed on the outer side of the coating body 10, the supporting corrugated ring 40 can be fixed to the coating body 10 by sewing or bonding. When the supporting corrugated ring 40 is disposed on the inner side of the coating body 10, the supporting corrugated ring 40 can be fixed to the coating body 10 by sewing or bonding, or it can be fixedly connected to the connecting corrugated ring 30 by sewing or welding.

[0081] In this embodiment, the connecting wave ring 30 is disposed on the inner side of the film-covering bracket 001, and the supporting wave ring 40 is disposed between the film-covering body 10 and the connecting wave ring 30. The supporting wave ring 40 is fixed to the film-covering body 10 by stitching to enhance the support strength of the proximal end of the film-covering body 10 and prevent internal leakage.

[0082] Among them, combined Figure 1 As shown, the wire diameter of the supporting coil 40 is smaller than that of the connecting coil 30. Since the supporting coil 40 supports the covering body 10 to make the covering body 10 adhere to the inner wall of the blood vessel after the covered stent 001 is implanted into the blood vessel, the radial support force of the supporting coil 40 will directly affect the pressure of the covered stent 001 on the inner wall of the blood vessel.

[0083] In this embodiment, by setting the wire diameter of the support coil 40 to be smaller than that of the connecting coil 30, the radial support force of the support coil 40 is reduced, making the contact surface between the support coil 40 and the vascular endothelial wall more flexible, causing less irritation to the vascular endothelial wall, and reducing the likelihood of new stent-related ruptures at the proximal end of the covered stent 001 in the long term after surgery. In other embodiments, the radial support force of the support coil 40 can be reduced to less than that of the connecting coil 30 by changing the materials of the support coil 40 and the connecting coil 30, selecting a braided wire with lower hardness. Furthermore, the hardness of the support coil 40 and the connecting coil 30 can be adjusted by changing the processing technology, such as changing the temperature or time of heat treatment.

[0084] On the other hand, such as Figure 9 and Figure 10As shown, the release mechanism 60 of the delivery device includes a sheath 61 for receiving and delivering the covered stent 001, and a sheath core 62 disposed within the sheath 61. When the covered stent 001 is delivered to the vascular lesion site, the covered stent 001 is loaded between the sheath 61 and the sheath core 62, and the covered stent 001 is in a compressed state. The compressed state of the covered stent 001 is as follows: Figure 12 and Figure 13 As shown.

[0085] Because this application provides a support wave 40 at the proximal edge of the covered body 10, the support strength of the covered body 10 is enhanced by the support wave 40, thereby effectively preventing blood leakage. However, increasing the support wave 40 will increase the radial dimension of the covered stent 001 in the compressed state. In order to smoothly insert the covered stent 001 into the sheath 61, the radial diameter of the sheath 61 needs to be adjusted to accommodate the covered stent 001 with a larger radial diameter.

[0086] For the sheath 61 inserted into the blood vessel, a smaller radial diameter of the sheath 61 is more conducive to delivering the covered stent 001 to the lesion site. Therefore, in this embodiment, the wire diameter of the supporting coil 40 is set to be smaller than that of the connecting coil 30. This not only reduces the radial support force of the supporting coil 40, making the contact surface between the supporting coil 40 and the inner wall of the blood vessel more flexible, but also reduces the radial dimension when the covered stent 001 is in a compressed state. This makes it easier for the covered stent 001 to be inserted into the sheath 61 with a smaller radial dimension, thereby facilitating the delivery of the covered stent 001 to the lesion site by the sheath 61.

[0087] In this embodiment, the connecting wavering 30 and the supporting wavering 40 are sewn and fixed to the coating body 10 by sutures, and the supporting wavering 40 is an integral structure. Figure 8 As shown. When testing the radial support force of the connecting wavering 30 and the supporting wavering 40, the sutures used to fix the connecting wavering 30 and the supporting wavering 40 are removed, the connecting wavering 30 and the supporting wavering 40 are removed from the covering body 10, and the radial support force of the connecting wavering 30 and the supporting wavering 40 are tested respectively. It can be seen that the radial support force of the supporting wavering 40 is less than that of the connecting wavering 30.

[0088] In other embodiments, the supporting wavering 40 can also be formed by stacking multiple sub-waverings, for example, two sub-waverings are respectively sewn onto the coating body 10 to form the supporting wavering 40. If the supporting wavering 40 is formed by stacking multiple sub-waverings, when testing the radial support force of the supporting wavering 40, the sutures used to fix the connecting wavering 30 are removed, the connecting wavering 30 is taken off, and then the radial support force of the supporting wavering 40 and the coating body 10 as a whole is tested; when testing the radial support force of the connecting wavering 30, the sutures used to fix the supporting wavering 40 are removed, the supporting wavering 40 is taken off, and then the radial support force of the connecting wavering 30 and the coating body 10 as a whole is tested. It can be seen that the radial support force of the supporting wavering 40 and the coating body 10 as a whole is less than the radial support force of the connecting wavering 30 and the coating body 10 as a whole.

[0089] On the other hand, since the covered stent 001 of this application is provided with a groove portion 50 and a branch stent 003, the covered stent 001 can extend to the ascending aorta of the aorta, and the groove portion 50 and the branch stent 003 ensure blood flow to the branch vessels at the aortic arch. Therefore, the covered stent 001 of this application can be used for the treatment of aortic aneurysms and aortic dissections in the ascending aorta.

[0090] However, the inner wall of the ascending aorta is quite sensitive, and the blood pressure there is high. If the covered stent 001 exerts significant stimulation on the inner wall, the patient is prone to discomfort under the impact of the high blood pressure in the ascending aorta. Therefore, this application reduces the wire diameter of the support coil 40 so that it is smaller than the wire diameter of the connecting coil 30. This reduces the stimulation of the support coil 40 on the inner wall of the blood vessel while ensuring that the covered stent 10 adheres to the vessel wall, thus alleviating patient discomfort.

[0091] Furthermore, combined Figures 6 to 8 As shown, the number of bands in the support wave loop 40 is greater than the number of bands in the connecting wave loop 30. The support wave loop 40 includes several support waveform segments 41 connected in sequence. The number of bands in the support wave loop 40 is the number of support waveform segments 41. The number of bands in the connecting wave loop 30 is the total number of fixed waveform segments 32 and movable waveform segments 31. The number of bands in the support wave loop 40 is set to be greater than the number of bands in the connecting wave loop 30.

[0092] Since the supporting wave coil 40 is positioned between the covered body 10 and the connecting wave coil 30, and the radial supporting force of the connecting wave coil 30 is greater than that of the supporting wave coil 40, the connecting wave coil 30 supports the supporting wave coil 40 from the inside after the covered stent 001 is fully deployed. In this embodiment, by setting the number of wavebands in the supporting wave coil 40 to be greater than the number of wavebands in the connecting wave coil 30, the radial supporting force provided by the connecting wave coil 30 is dispersed, resulting in more uniform pressure on the vascular wall. Furthermore, by increasing the number of wavebands in the supporting wave coil 40, there are more connection points between the supporting wave coil 40 and the proximal end of the covered body 10. After the supporting wave coil 40 is fully deployed, the shape of the proximal end of the covered body 10 is closer to a circle, thereby further reducing the risk of endoleak in the covered stent 001.

[0093] Specifically, the wire diameter of the supporting waveguide 40 is 0.1mm to 0.5mm, the wire diameter of the connecting waveguide 30 is 0.3mm to 1mm, and the number of wavebands in the supporting waveguide 40 is 2 to 5 times the number of wavebands in the connecting waveguide 30. In this embodiment, the wire diameter of the supporting waveguide 40 is 0.2mm, the wire diameter of the connecting waveguide 30 is 0.5mm, the number of wavebands in the supporting waveguide 40 is 3 times the number of wavebands in the connecting waveguide 30, and both the supporting waveguide 40 and the connecting waveguide 30 are made of nickel-titanium wire. Figure 6 and Figure 7 As shown, the connecting wave coil 30 includes a plurality of connecting wave section sections 301 connected in sequence, and the plurality of connecting wave section sections 301 are connected end to end in sequence to form a ring-shaped support structure. The connecting wave section section 301 includes a plurality of fixed waveform segments 32 and at least one movable waveform segment 31, wherein the fixed waveform segment 32 is fixedly connected to the film covering body 10, and the movable waveform segment 31 is movably connected to the film covering body 10 and is connected to the release mechanism of the film covering support 001 through the movable waveform segment 31.

[0094] In this embodiment, the connecting band section 301 includes three movable waveform segments 31 that are movably connected to the film covering body 10. The three movable waveform segments 31 are evenly arranged along the circumferential direction of the film covering body 10, or they can be arranged adjacently or at intervals. The three movable waveform segments 31 are used to connect to the release mechanism of the conveying device and are released after the film covering bracket 001 is positioned.

[0095] In other embodiments, the connecting band section 301 may also include four or six active waveform segments 31 for adapting to the release mechanism of different specifications of conveying devices.

[0096] Combination Figure 9 and Figure 10As shown, the sheath core 62 is provided with a hook 63. The sheath core 62 passes through the inside of the film-coated bracket 001 and is located in the middle of the film-coated bracket 001. The hook 63 is used to connect with the connecting wave coil 30. During the conveying process of the film-coated bracket 001, the hook 63 hooks and fixes with the active waveform segment 31 of the connecting wave, thereby restricting the position of the film-coated bracket 001 in the conveyor. The front end of the sheath tube 61 is also provided with a guide part 64, and the front end of the guide part 64 is tapered.

[0097] During the release of the covered stent 001, after the delivery device delivers the covered stent 001 to the predetermined position, the covered stent 001 is completely released into the blood vessel by releasing the hook 63 and hooking and fixing it with the movable waveform segment 31.

[0098] The hook 63 is hooked and connected to the movable waveform segment 31. When the hook 63 is released from the connection with the movable waveform segment 31, the covered stent 001 is completely released into the blood vessel. Before the hook 63 is released from the connection with the movable waveform segment 31, the proximal end of the covered stent 001 is in a semi-released state due to the structural arrangement of the connecting coil 30. The semi-released state refers to the proximal end of the covered stent 001 being partially deployed.

[0099] In this embodiment, the connecting coil 30 includes three circumferentially evenly distributed movable waveform segments 31. Since the sheath core 62 is located in the middle of the inner side of the coating support 001, and the hook 63 is disposed on the sheath core 62, when the movable waveform segments 31 are hooked and fixed on the hook 63, the hook 63 simultaneously binds the three movable waveform segments 31 to the middle of the inner side of the coating support 001.

[0100] The fixed waveform segment 32 includes fixed peaks 321, fixed troughs 323, and fixed wave rods 322 connecting adjacent fixed peaks 321 and fixed troughs 323. The movable waveform segment 31 includes movable peaks 311, movable troughs 313, and movable wave rods 312 connecting adjacent movable peaks 311 and movable troughs 313. The movable troughs 313 are fixedly connected to the coating body 10, and the movable peaks 311 and movable wave rods 312 are movably connected to the coating body 10. In this embodiment, the fixed waveform segment 32 and the movable waveform segment 31 are spaced apart.

[0101] Before the hook 63 disengages from the movable waveform segment 31, the movable waveform segment 31, under the restraint of the hook 63, has its movable peak 311 connected to the hook 63 and its movable trough 313 connected to the coating body 10. The coating body 10, connected to the movable trough 313, is pulled inwards by the movable waveform segment 31, causing it to shift towards the inward direction of the coating support 001. Meanwhile, the fixed waveform segment 32, under its own elastic force, exerts a radially outward supporting force on the coating body 10, thereby expanding the coating body 10.

[0102] Therefore, before the hook 63 disengages from the connection with the movable waveform segment 31, the fixed waveform segment 32 expands the endothelial body 10 outward, while the movable waveform segment 31 pulls the endothelial body 10 inward, causing the front end of the endothelial stent 001 to be in a semi-released state. The top of the fixed waveform 321 is flush with the proximal edge of the endothelial body 10, and the top of the movable waveform 311 is also flush with the proximal edge of the endothelial body 10. This reduces the irritation of the endothelial body 10 to the vessel wall compared to a bare stent that protrudes beyond the proximal end of the endothelial body 10 and is connected to the release structure of the delivery device.

[0103] In this application's technical solution, the top edges of both the fixed peak 321 and the movable peak 311 are flush with the proximal end of the covered body 10, replacing the bare stent configuration of the traditional aortic covered stent 001. Therefore, after the covered stent 001 is deployed, there is no bare stent portion extending beyond the proximal end of the covered body 10, thus avoiding secondary damage to the vessel wall caused by the bare stent portion or barbs of the traditional covered stent 001. While protecting the patient's arterial vessels, it also avoids leakage caused by the bird's beak-like structure of the covered stent 001, further improving the sealing performance of the covered stent 001.

[0104] Specifically, when the covered stent 001 is implanted at the aortic arch, the covered stent 001 is generally curved. The side of the covered stent 001 facing the branch vessels of the aortic arch is typically defined as the greater curvature side of the covered stent 001, and the side of the covered stent 001 away from the branch vessels of the aortic arch is defined as the lesser curvature side of the covered stent 001. In this application, the groove portion 50 is located on the greater curvature side of the covered stent 001.

[0105] Furthermore, when the band on the lesser bend side of the main stent waveform 20 is the main stent peak 21, the main stent peak 21 on the lesser bend side is coaxial with the fixed peak 321 or the movable peak on the lesser bend side and is arranged in the same axial direction. When the band on the lesser bend side of the main stent waveform 20 is the main stent trough 23, the main stent trough 23 on the lesser bend side is coaxial with the fixed trough 323 or the movable trough 313 on the lesser bend side and is arranged in the same axial direction. Through the above settings, this embodiment ensures that the covered stent 001 has better compliance on the lesser bend side at the corresponding position of implantation in the aortic arch.

[0106] That is, when the main support waveband 20 is located on the side opposite to the groove 50 and its band is the main support wave crest 21, the main support wave crest 21 on the side opposite to the groove 50 is in the same direction as the fixed wave crest 321 or the movable wave crest 311 on the side opposite to the groove 50, and they are on the same axis. When the main support waveband 20 is located on the side opposite to the groove 50 and its band is the main support wave trough 23, the main support wave trough 23 on the side opposite to the groove 50 is in the same direction as the fixed wave trough 323 or the movable wave trough 313 on the side opposite to the groove 50, and they are on the same axis. When the main support waveband 20 is located on the large bend side and its band is the main support wave crest 21, the main support wave crest 21 on the large bend side is in the same direction as the fixed wave trough 323 or the movable wave trough 313 on the large bend side, and they are on the same axis. When the main support wave 20 is located in the main support wave trough 23 on the side of the large bend, the main support wave trough 23 on the side of the large bend is in the same direction as the fixed wave peak 321 or the moving wave peak 311 on the side of the large bend, and is on the same axis.

[0107] Through the above-described configuration, this application ensures that the covered stent 001 has higher rigidity on the greater curvature side at the implantation site corresponding to the aortic arch, thereby effectively preventing stent shortening. In this embodiment, the connecting waveform portion 301 located on the greater curvature side of the covered stent 001 is a fixed waveform segment 32.

[0108] Specifically, one of the fixed peaks 321 of the connecting wave loop 30 is located on the midline of the groove portion 50, and one of the main stent peaks 21 of the main stent wave loop 20 adjacent to the connecting wave loop 30 is located on the midline of the groove portion 30, thereby facilitating better compliance of the covered stent 001 after implantation at the aortic arch position. In this embodiment, the midline of the groove portion 30 is defined as follows: the line connecting the two vertices of the edge where the groove portion 30 connects to the covered body 10, where the vertex is the point farthest from the central axis of the covered stent 001. In this embodiment, as... Figure 11 As shown, the axial height of the main support corrugation 20 on the large bend side is greater than the axial length of the corrugation on the small bend side, resulting in a shorter distance between adjacent main support corrugations 20 on the large bend side compared to the distance between adjacent main support corrugations 20 on the small bend side. Therefore, the large bend side of the membrane body 10 is less prone to shortening, while the small bend side exhibits better flexibility.

[0109] In practical implementation, the wire diameter D20 of the main support corrugated coil 20 is 0.3 to 0.45 mm, the wave height H20 is 6 to 15 mm, and the wave number T20 is 6 to 10. For example, the wire diameter D20 of the main support corrugated coil 20 is 0.3 mm, the wave height H20 is 8 mm, and the wave number T20 is 8. The wire diameter D30 of the connecting corrugated coil 30 is 0.3 to 0.45 mm, the wave height H30 is 10 to 15 mm, and the wave number T30 is 4 to 8. For example, the wire diameter D30 of the connecting corrugated coil 30 is 0.4 mm, the wave height H30 is 12 mm, and the wave number T30 is 6.

[0110] The interval between two adjacent main support corrugations 20 is 1mm to 2mm, and the interval between the main support corrugation 20 closest to the connecting corrugation 30 and the connecting corrugation 30 is 1mm to 2mm. The fixed corrugation 323 and the movable corrugation 313, which are fixedly connected to the coating body 10, are each provided with a stitching point 33. The stitching point 33 covers the rounded corners of the fixed corrugation 323 and the movable corrugation 313. The axial length of the stitching point 33 is set to be greater than 0 and less than or equal to 5mm to ensure that the fixed corrugation 32 of the connecting corrugation 30 assembled in the conveyor does not shift relative to the coating body 10, thereby preventing the connecting corrugation 30 from protruding from the coating body 10 after being released from the conveyor. The stitching point uses sutures to sew the fixed corrugation 323 and the movable corrugation 313 to the coating body 10.

[0111] In other embodiments, if the connecting coil 30 is fixedly connected to the film body 10 by adhesive bonding, the stitching point 33 can also be replaced by an adhesive bonding point.

[0112] like Figure 8 As shown, the support wave coil 40 includes several sequentially connected support wave segments 41. The support wave segments 41 are arranged in an inverted figure-eight or diamond shape, and multiple support wave segments 41 form a nickel-titanium alloy ring for supporting the proximal end of the coating body 10. The inverted figure-eight or diamond-shaped support wave segments 41 enhance the support strength of the support wave coil 40, resulting in better wall adhesion of the coating bracket 001. The allowable assembly deviation of the support wave coil 40 is ±1mm, and the allowable assembly deviation of the fixed wave crest 321 is also ±1mm.

[0113] In this embodiment, as Figure 14 As shown, the connecting wave section 301 and the supporting wave segment 41 are offset in the circumferential direction. Specifically, the connecting wave loop 30 is set half a phase away from the supporting wave loop 40, so that the connecting wave loop 30 and the supporting wave loop 40 together have better support performance for the coating body 10.

[0114] It should be noted that the above-mentioned dimensional parameters of the covered support are merely illustrative examples of this embodiment and are applicable to most application scenarios, but do not constitute a limitation on this application. If there are special dimensional requirements, the technical solution of this application may also adopt other dimensional parameters.

[0115] The supporting corrugated ring 40 can be fixedly connected to the coating body 10 by stitching or bonding. The supporting corrugated ring 40 can also be fixedly connected to the connecting corrugated ring 30 by stitching, bonding, or welding. In this embodiment, the supporting corrugated ring 40 is fixedly connected to the coating body 10 by stitching.

[0116] like Figure 3 and Figure 5 The proximal end of the supporting wave ring 40 is flush with the proximal edge of the covering body 10; or the distal end of the supporting wave ring 40 is flush with the distal edge of the connecting wave ring 30, and the proximal end of the supporting wave ring 40 is further away from the proximal end of the covering body 10 than the proximal end of the connecting wave ring 30, so as to facilitate the connection of the connecting wave ring 30 to the conveyor; or the supporting wave ring 40 is disposed between the distal end of the connecting wave ring 30 and the proximal end of the covering body 10, so as to both prevent internal leakage and facilitate connection.

[0117] In this embodiment, the support wave coil 40 is fixedly connected to the coating body 10 by stitching. The proximal crest of the support wave coil 40 is flush with the proximal edge of the coating body 10 to enhance the support strength of the proximal end of the coating body 10, thereby better preventing internal leakage.

[0118] Furthermore, since the proximal peak of the support wave coil 40 is flush with the proximal edge of the covered body 10, when the covered stent 001 is in the semi-released state, the proximal edge of the covered body 10 is displaced outward under the radial support force of the support wave coil 40, so that the proximal edge of the covered body 10 can be closer to the inner wall of the blood vessel to a greater extent before the covered stent 001 is fully released.

[0119] Before the hook 63 releases from the connection with the wave segment, the hook 63 binds the active wave peak 311 of the active wave segment 31 to the middle of the covered stent 001. Therefore, at the moment the hook 63 releases from the binding of the active wave segment 31, the active wave segment 31 will rebound under its own elastic force, especially the active wave peak 311 located at the proximal end, which moves the greatest distance. During the rebound process of the active wave segment 31, the active wave segment 31 will first contact the covered body 10, and then drive the covered body 10 to contact the inner wall of the blood vessel.

[0120] If the supporting wave coil 40 is not provided on the covered body 10, the active waveform segment 31 will quickly cause the covered body 10 to adhere to the inner wall of the blood vessel upon contact with the restraint, causing impact on the inner wall of the blood vessel, leading to patient discomfort, and even vasospasm. In this embodiment, because the supporting wave coil 40 is provided at the proximal end of the covered body 10, and the proximal peak of the supporting wave coil 40 is flush with the proximal edge of the covered body 10, the proximal edge of the covered body 10 can approach the inner wall of the blood vessel to a greater extent before the covered stent 001 is fully released. Therefore, at the moment the active waveform segment 31 contacts the restraint, the impact of the active waveform segment 31, especially the active wave peak 311, on the inner wall of the blood vessel is greatly reduced.

[0121] In other embodiments, the support wave coil 40 may also be configured as a sine wave, a Z-shaped wave, an M-shaped wave, or a V-shaped wave. Therefore, the structure of the support wave coil 40 described above in this application is merely an example, and any other structure capable of supporting the film body 10 can be applied to this application. A developing element is provided on the main support member 100 and / or the supporting film 10. When the developing element is provided on the main support member 100, for example, when the developing element is provided on the main support section 200, the developing element can be welded, sewn, or bonded to the main support section 200. When the developing element is provided on the supporting film 10, the developing element can be sewn or bonded to the supporting film 10.

[0122] Multiple contrast-enhancing elements are provided, and these elements can be arranged in O, figure-eight, or N shapes, distinguished by their different shapes. Alternatively, the contrast-enhancing elements can be set as contrast points of different densities, distinguished by their different color depths. By setting multiple contrast-enhancing elements on the covered stent 001, it is easier for doctors and other surgical personnel to determine the position of the covered stent 001.

[0123] In this embodiment, a developing element 11 is disposed on the supporting film 10. The developing element 11 includes a first developing point 111, a second developing point 112, and a third developing point 113, used to display the position of the proximal end of the film-coated support 001 and the position of the groove portion 50. The first developing point 111 is disposed on the centerline of the groove portion 50 and at the edge of the proximal end of the support frame segment 300. The first developing point 111 can be disposed on the support frame segment 300 or on the film-coated body 10. The second developing point 112 is disposed on the centerline of the groove portion 50 and at the edge of the groove portion 50 near the support frame segment 300. The second developing point 112 is disposed on the film-coated body 10. The third developing point 113 is disposed on the opposite side of the centerline of the groove portion 50 and at the edge of the proximal end of the support frame segment 300. The third developing point 113 can be disposed on the support frame segment 300 or on the film-coated body 10.

[0124] The shape of the first developing point 111 is different from the shape of the second developing point 112, the shape of the first developing point is different from the shape of the third developing point 113, and the shapes of the second developing point 112 and the third developing point 113 can be the same or different. In this embodiment, the first developing point 111 is in the shape of an 8, and the second developing point 112 and the third developing point 113 are in the shape of an O.

[0125] The first developing point 111 and the third developing point 113 are used to display the proximal position of the coating support 001 and the angle at which the groove portion 50 is positioned. The second developing point 112 is used to display the position of the edge of the groove portion 50.

[0126] Since both the first imaging point 111 and the third imaging point 113 are located at the proximal edge of the support segment 300, the proximal position of the covered stent 001 can be displayed during implantation. Furthermore, the first imaging point 111 is positioned towards the branch arteries of the aortic arch, while the third imaging point 113 is positioned away from the branch arteries of the aortic arch. Because the first imaging point 111 and the recess 50 are oriented in the same direction, the angle at which the recess 50 is positioned can also be displayed.

[0127] The first developing point 111 is located at the proximal edge of the large bend side of the coated stent 001, indicating the position of the proximal large bend side of the coated stent 001, and the third developing point 113 is located at the proximal edge of the small bend side of the coated stent 001, indicating the position of the small bend side of the coated stent 001.

[0128] In this embodiment, the recessed portion 50 is aligned with the branch vessels of the aortic arch. After the covered stent 001 extends into the aorta, it can cover the ascending aorta. The branch stent 003 connected to the recessed portion 50 ensures blood flow to the branch vessels at the aortic arch. Therefore, the covered stent 001 of this embodiment can be used to treat aortic aneurysms or aortic dissections in the ascending aorta.

[0129] When treating aortic aneurysms or aortic dissections of the ascending aorta, doctors can determine the position of the drape body 10 by observing the first imaging point 111 and the third imaging point 113, ensuring that the drape body 10 can completely cover the entire aortic aneurysm or aortic dissection, thus ensuring the smooth progress of the surgery.

[0130] In this embodiment, as Figure 15 and Figure 16As shown, the membrane body 10 is also provided with an eighth imaging point 118, which is located at the midpoint of the groove portion 50 and at the edge of the end of the groove portion 50 that is away from the support frame section 300. Furthermore, imaging strips 119 can be provided on both sides of the support ring provided within the suture ring 53 to visualize the outline of the groove membrane 52, thereby facilitating positioning during implantation of the membrane-covered stent 001.

[0131] In this embodiment, by setting an eighth imaging point 118 and imaging strip 119 on the covered stent 001, the overall edge position of the groove portion 50 can be indicated during the operation, and the relative position of the guidewire with respect to the groove portion 50 can be indicated, thereby assisting the doctor in confirming that the guidewire is located inside the groove when the guidewire is inserted, ensuring the success rate of the operation.

[0132] Furthermore, when the through hole 521 is located near one end of the support frame section 300, the distance between the through hole 521 and the proximal end of the support frame section 300 is less than or equal to the distance between the second developing point 112 and the proximal end of the support frame section 300, thereby displaying the positional relationship between the edge of the groove portion 50 and the through hole 521 through the second developing point 112.

[0133] Since the branch stent 003 is sutured to the groove 50 through the through-hole 521, there may be a suture edge between the through-hole 521 and the groove 50 during suturing, or the through-hole 521 may be recessed in the design. Therefore, in the above cases, the distance between the through-hole 521 and the proximal end of the support segment 300 is set to be less than the distance between the second imaging point 112 and the proximal end of the support segment 300. With the above setting, when the doctor inserts the guidewire from the groove 50 through the through-hole 521 into the branch stent 003, he can accurately know the position of the edge of the groove 50, which provides convenience for the doctor's operation.

[0134] In summary, compared with the existing connecting coil structure of aortic endovascular stent grafts, this application avoids secondary damage to the vessel wall in the anchoring area caused by the exposed connecting coil. The semi-connection between the movable waveform segment 31 of the connecting coil 30 and the endovascular body 10 satisfies the need for cooperation with the release device after the endovascular stent graft 001 is deployed. In addition, the supporting coil 40 can strengthen the support of the endovascular graft, ensuring that the proximal end of the endovascular stent graft 001 can completely adhere to the vessel wall after deployment, avoiding a beak-like appearance at the proximal end of the stent that could lead to leakage.

[0135] Example 2: Example 2 of this application provides a covered stent, such as... Figure 17As shown, the similarities between Embodiment 2 and Embodiment 1 will not be repeated here. The difference between Embodiment 2 and Embodiment 1 is that adjacent main support corrugations 20 are connected by connecting rods 24. Multiple connecting rods 24 are arranged on the same side as the groove portion 50, and the centerline of the multiple connecting rods 24 and the groove portion 50 are on the same straight line, thereby increasing the support strength of the film-coated support 001. The connecting rods 24 are connected to the main support corrugations 20 by steel sleeves, or the connecting rods 24 are welded to the main support corrugations 20.

[0136] It should be understood that in other embodiments, the multiple connecting rods 24 can also be staggered, and two adjacent main support wave coils 20 can be connected by a connecting rod 24. The connecting rod 24 can be set on the same side of the groove portion 50.

[0137] In this embodiment, by setting a connecting rod 24 between adjacent main stent coils 20, the bending direction of the covered stent 001 after implantation is ensured, and the support of the covered stent 001 is improved.

[0138] Embodiment 3: Embodiment 3 of this application provides a covered stent, such as... Figure 18 and Figure 19 As shown, the similarities between Embodiment 3 and Embodiment 1 will not be repeated. The difference between Embodiment 3 and Embodiment 1 is that the movable wave rod 312 is set at a preset angle to the coating body 10. Specifically, the movable wave rod 312 bends towards the inside of the coating body 10 at a preset angle greater than 0° and less than or equal to 45°, for example, 30°. Thus, the movable wave crest 311 follows the movable wave rod 312 and bends towards the inside of the coating body 10. The distance between the movable wave crest 311 and the center of the connecting wave coil 30 is less than the distance between the fixed wave crest 321 and the center of the connecting wave coil 30.

[0139] Because the unsutured active waveform segment 31 has radial elastic force before the post-release process, a rebound force will be generated towards the outside of the covered stent 001 during the post-release process. In this embodiment, by bending the active wave rod 312, which is movably connected to the covered body 10, from its root towards the inside of the covered stent 001, the impact of the rebound force of the active waveform segment 31 on the blood vessel during the post-release process is avoided. Compared with the connection wave coil setting of the traditional covered stent 001, the inward bending of the active wave rod 312 can also reduce the long-term stimulation of the blood vessel inner wall caused by the active wave peak 311 pressing against it for a long time.

[0140] Example 4: Example 4 of this application provides a covered stent, such as... Figure 20 and Figure 21As shown, the similarities between Embodiment 4 and Embodiment 2 will not be repeated here. The difference between Embodiment 4 and Embodiment 3 is that the movable wave rod 312 includes a bent portion 314 connected to the movable wave crest 311, and the bent portion 314 is set at a preset angle to the coating body 10. The bent portion 314 bends towards the inside of the coating body 10, with a preset angle greater than 0° and less than or equal to 45°, for example, 30°. The length ratio of the bent portion 314 to the movable wave rod 312 is greater than or equal to 30% and less than or equal to 60%. Thus, the movable wave crest 311 follows the bent portion 314 and bends towards the inside of the coating body 10. The distance between the movable wave crest 311 and the center of the connecting wave coil 30 is less than the distance between the fixed wave crest 321 and the center of the connecting wave coil 30.

[0141] In this embodiment, the length of the movable wave rod 312 in the range of 30% to 60% from the near end is set as a bending portion 314. Since the bending portion 314 is provided between the movable wave crest 311 and the movable wave trough 313, and the bending portion 314 is close to the movable wave crest 311, the movable wave rod 312 can provide support force at the position near the root of the movable wave trough 313.

[0142] It should be noted that, in order to avoid the impact of the rebound force of the active waveform segment 31 on the blood vessel during the subsequent release process, this embodiment adopts the method of setting a bending part 314 on the active wave rod 312, thereby reducing the instantaneous impact force of the active waveform segment 31 on the inner wall of the blood vessel during the rebound process.

[0143] Furthermore, if the length of the bend 314 is too long, it will severely reduce the support of the active waveform segment to the vascular wall; if the length of the bend 314 is too short, it cannot effectively reduce the impact force of the active waveform segment during the rebound process. Therefore, setting the bend 314 within 10% to 60% of the proximal length of the active waveform rod 312 can reduce the impact force of the active waveform segment 31 on the vascular wall during the rebound process while ensuring that the active waveform segment 31 still has sufficient support for the vascular wall. In this embodiment, the bend 314 is set within 45% of the proximal length of the active waveform rod 312.

[0144] Furthermore, since the bend 314 bends inward toward the cover body 10, thrombi may accumulate on the bend 314 after prolonged stent implantation. Thrombi on the bend 314 with excessively large bending angles may dislodge. Therefore, the bending angle of the bend 314 should not be too large. Thus, the preset bending angle of the bend 314 in this application is set to 0° to 45°, ensuring that while the bend 314 bends inward toward the cover body 10, long-term accumulated thrombi will not dislodge, avoiding the risk of branch vessel embolism. In this embodiment, the preset bending angle of the bend 314 is set to 15°.

[0145] On the other hand, the larger the length of the bending portion 314 in this embodiment, the smaller the preset angle.

[0146] Because the main support 002 of this application has a branch support 003 inside, a guide wire is needed to establish the access path during the process of establishing the access path between the branch support 003 and the main support 002. If the gap between the bent portion 314 and the film body 10 is too large, the guide wire may accidentally pass through the gap between the bent portion 314 and the film body 10 when establishing the access path, resulting in the failure of the access path establishment. Therefore, in this embodiment, the larger the length of the bent portion 314, the smaller the preset angle, so as to ensure that the gap between the bent portion 314 and the film body 10 will not cause the guide wire to accidentally pass through, thereby causing the access path establishment to fail.

[0147] Therefore, this embodiment, in addition to avoiding the impact of the rebound force of the active waveform segment 31 on the blood vessel during the subsequent release process, can also provide support for the covered body 10, enhance the wall adhesion effect of the covered body 10, and further improve the effect of preventing blood leakage. Compared with the connection wave coil setting of the traditional covered stent 001, the inward bending of the active wave rod 312 can also reduce the long-term stimulation of the blood vessel wall caused by the active wave peak 311 pressing against the blood vessel wall for a long time.

[0148] Example 5: Example 5 of this application provides a covered stent, such as... Figure 22 As shown, the similarities between Embodiment 5 and Embodiment 1 will not be repeated here. The difference between Embodiment 5 and Embodiment 1 is that the shape of the supporting wave ring 40 is the same as that of the connecting wave ring 30, both of which are wavy. The supporting wave ring 40 and the connecting wave ring 30 are staggered and the supporting wave ring 40 is completely fixed to the film body 10.

[0149] In this embodiment, both the support wave ring 40 and the connecting wave ring 30 are sinusoidal waveforms, and the position of the support wave ring 40 is the position corresponding to half a cycle of circumferential rotation of the connecting wave ring 30. The support wave ring 40 is fixed to the film body 10 by stitching.

[0150] The support wave coil 40 is disposed on the outer side of the membrane body 10 (at this time, in the radial direction, the membrane body 10 is located between the connecting wave coil 30 and the support wave coil 40), or in the radial direction, the support wave coil 40 is disposed on the inner side of the membrane body 10 and between the membrane body 10 and the connecting wave coil 30. This ensures that the active waveform segment 31 of the connecting wave coil 30 can be connected to the release mechanism of the delivery device, while ensuring the support of the proximal end of the membrane body 10, reducing the risk of blood leakage and reducing the stimulation of the blood vessel by the connecting wave coil 30.

[0151] Example 6: Example 6 of this application provides a covered stent, such as... Figure 23As shown, the similarities between Embodiment 6 and Embodiment 1 will not be repeated here. The difference between Embodiment 6 and Embodiment 1 is that the supporting wave ring 40 includes several independent supporting units 42, and each independent supporting unit 42 is distributed between the peaks and valleys of the connecting wave ring 30.

[0152] In this embodiment, the supporting wave ring 40 includes a plurality of circumferentially evenly distributed supporting units 42 between the crests and troughs of the connecting wave ring 30. Each supporting unit 42 is a ring-shaped structure, and the proximal end of the supporting unit 42 is flush with the proximal end of the covering body 10. In this embodiment, the supporting unit 42 is rhomboid, and the major axis of the rhombus is parallel to the longitudinal central axis of the covering support. In other embodiments, the supporting unit 42 can be elliptical, and its major axis is parallel to the longitudinal central axis of the covering support.

[0153] By setting a rhomboid or elliptical support unit 42 with its long axis parallel to the longitudinal central axis of the covered stent, a balance is achieved between reducing the radial dimension of the covered stent after compression and improving the strength of the proximal end of the covered body 10. This results in the proximal end of the covered body 10 not only having better support and reducing the risk of blood endoleak, but also having a smaller radially compressed dimension.

[0154] Example 7: Example 7 of this application provides a covered stent, such as... Figure 24 As shown, the similarities between Embodiment 7 and Embodiment 1 will not be repeated here. The difference between Embodiment 7 and Embodiment 1 is that the connecting wave loop 30 includes a plurality of connecting wave segments 301 connected in sequence. The connecting wave segments 301 include fixed waveform segments 32 and movable waveform segments 31 arranged in sequence at intervals. The connecting wave segments 301 are all disposed on the inner surface of the film body 10.

[0155] The fixed waveform segment 32 is arranged in a ring shape and is completely fixedly connected to the film-coating body 10. The movable waveform segment 31 is arranged between adjacent fixed waveform segments 32 and is arranged in a strip shape. The movable waveform segment 31 is movably connected to the film-coating body 10.

[0156] Specifically, the movable waveform segment 31 protrudes towards the proximal end of the coating body 10, forming a movable wave crest 311 for connection to the release mechanism of the conveying device. The proximal end of the movable wave crest 311 is flush with the proximal end of the coating body 10 or inside the movable wave crest 311 (that is, the movable wave crest 311 is closer to the distal end of the coating body 10 than the proximal end of the coating body 10). Movable wave rods 312 are respectively provided on both sides of the movable wave crest 311, and the movable wave rods 312 on both sides are fixedly connected to the fixed waveform segment 32 on the corresponding side.

[0157] The fixed waveform segment 32 is fixedly connected to the film body 10 by stitching, and the movable waveform segment 31 is connected to the fixed waveform segment 32 by welding.

[0158] In this embodiment, the active wave peak 311 located inside the membrane body 10 is connected to the release structure of the delivery device, thereby reducing the stimulation of the active wave peak 311 on the inner wall of the blood vessel while achieving the purpose of releasing the stent.

[0159] Example 8: Example 8 of this application provides a covered stent, such as... Figure 25 As shown, the similarities between Embodiment 8 and Embodiment 7 of this application will not be repeated. The difference between Embodiment 8 and Embodiment 7 is that the movable waveform segment 31 is arranged in a ring shape, and part of the movable waveform segment 31 is fixedly connected to the film covering body 10, while part is separated from the film covering body 10. The fixed waveform segment 32 is arranged between adjacent movable waveform segments 31. The fixed waveform segment 32 is arranged in a strip shape and is completely fixedly connected to the film covering body 10. The fixed waveform segment 32 can be a straight line segment or a curved segment.

[0160] Specifically, the movable waveform segment 31 includes a movable proximal end portion 316 movably connected to the film-coating body 10 on one side near the proximal end of the film-coating body 10, and a movable distal end portion 315 fixedly connected to the film-coating body 10 on one side away from the proximal end of the film-coating body 10. The movable proximal end portion 316 is flush with the proximal end of the film-coating body 10, or a predetermined recess distance is provided between the movable proximal end portion 316 and the film-coating body 10. The predetermined recess distance is 0.5 mm to 2 mm. By setting the predetermined recess distance, there is sufficient installation clearance between the movable proximal end portion 316 and the film-coating body 10, thereby ensuring that the movable proximal end portion 316 does not detach from the film-coating body 10.

[0161] In this embodiment, the active proximal end 316 located near the active waveform segment 31 is connected to the release structure of the delivery device, thereby realizing the purpose of releasing the stent while housing the connecting coil 30 inside the covered body 10 to reduce the stimulation of the bare stent to the inner wall of the blood vessel.

[0162] Example 9: Example 9 of this application provides a covered stent, such as... Figure 26 and Figure 27 As shown, the similarities between Embodiment 9 and Embodiment 1 will not be repeated here. The difference between Embodiment 9 and Embodiment 1 lies in the combination of... Figure 1 As shown, the developing element 11 also includes a fourth developing point 114 and a fifth developing point 115 disposed on the coating body 10. The fourth developing point 114 and the fifth developing point 115 are respectively disposed on both sides of the coating body 10 near the proximal end of the groove portion 50.

[0163] The fourth imaging point 114 and the fifth imaging point 115 are respectively located on both sides of the proximal end of the grooved film 52, and are used to indicate the position of the two sides of the proximal end of the grooved film 52. In this embodiment, the fourth imaging point 114 and the fifth imaging point 115 enable doctors to accurately determine the position of the proximal end of the grooved film 52 located at the bottom of the groove portion 50, which provides convenience for doctors' observation and operation.

[0164] Furthermore, in this embodiment, a sixth developing point 116 and a seventh developing point 117 are also provided on the groove coating 52 of the groove portion 50. The sixth developing point 116 and the seventh developing point 117 are respectively located in the middle of the proximal end and the distal end of the groove coating 52.

[0165] Among them, the first developing point 111 and the third developing point 113 have different shapes, the sixth developing point 116 has a different shape than the second developing point 112, and the seventh developing point 117 and the eighth developing point 118 have different shapes, thus making it easier to distinguish each developing point.

[0166] This embodiment, by setting the sixth imaging point 116 and the seventh imaging point 117, can indicate the depth of the branch stent 003 embedded in the proximal and distal ends of the groove portion 50 during the operation. In conjunction with the eighth imaging point 118, it assists the surgeon in locating the embedded branch stent 003 when confirming the guidewire access, providing convenience for the surgeon's operation and improving the success rate and efficiency of the surgery. In summary, this application provides a covered stent that, compared with the existing connecting coil structure of aortic covered stents, avoids secondary damage to the inner wall of the anchoring area caused by the exposed connecting coil. The segmented active waveform of the connecting coil and the semi-connection method of the covered body meet the requirements for the use of the post-covered stent release device.

[0167] The above are merely preferred embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A film-coated support, comprising a main support member and a film-coated body disposed on the main support member, characterized in that, The main support component includes a main support section and a support frame section disposed near the proximal end of the main support section. The support frame section includes a connecting wave loop connected to the coating body. The connecting wave loop includes several fixed waveform segments fixedly connected to the coating body and at least one movable waveform segment movably connected to the coating body. The proximal end of the fixed waveform segment is flush with the proximal edge of the coating body, or is closer to the distal end of the coating body than the proximal edge of the coating body. The movable waveform segment includes movable wave crests, movable wave troughs, and movable wave rods connecting adjacent movable wave crests and movable wave troughs. The movable wave troughs are fixedly connected to the coating body, and the movable wave crests and movable wave rods are movably connected to the coating body. The support frame section also includes a support wave coil disposed at the port of the film-coated body.

2. The covered stent according to claim 1, characterized in that, The fixed waveform segments and the active waveform segments are arranged alternately.

3. The covered stent according to claim 1, characterized in that, The fixed waveform segment includes fixed peaks, fixed troughs, and fixed wave bars connecting adjacent fixed peaks and fixed troughs. The top of the fixed peak is flush with the proximal edge of the coating body, or is closer to the distal end of the coating body than the proximal edge of the coating body.

4. The covered stent according to claim 3, characterized in that, The movable wave rod is set at a preset angle to the film-coated body; or the movable wave rod includes a bent portion connected to the movable wave crest, and the bent portion is set at a preset angle to the film-coated body.

5. The covered stent according to claim 4, characterized in that, The movable wave rod bends toward the inside of the film-coated body, or the bent portion bends toward the inside of the film-coated body, the preset angle is greater than 0° and less than or equal to 45°, and the percentage of the ratio of the length of the bent portion to the length of the movable wave rod is greater than or equal to 10% and less than or equal to 60%.

6. The covered stent according to claim 1, characterized in that, The diameter of the supporting wave coil is smaller than the diameter of the connecting wave coil.

7. The covered stent according to claim 6, characterized in that, The number of bands in the supporting waveband is greater than the number of bands in the connecting waveband.

8. The covered stent according to claim 6, characterized in that, The supporting wave ring is fixedly connected to the film body, or the supporting wave ring is fixedly connected to the connecting wave ring.

9. The covered stent according to claim 8, characterized in that, The proximal end of the supporting wave ring is flush with the proximal edge of the covering body, or the distal end of the supporting wave ring is flush with the distal edge of the connecting wave ring, or the supporting wave ring is disposed between the distal end of the connecting wave ring and the proximal end of the covering body.

10. The covered stent according to any one of claims 1-9, characterized in that, The main support member is provided with a recessed portion facing inward, the recessed portion including a recessed support member connected to the main support member and a recessed coating provided on the recessed support member; a developing element is provided on the main support member and / or the coating body.

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