Groove bracket and manufacturing method thereof
By using a mesh support cap woven with braided wire in the grooved support, the support cap can be deformed and fixedly connected, solving the problem of the support cap obstructing the guide wire and external branch support, thus improving the treatment effect and safety.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- LIFETECH SCI (SHENZHEN) CO LTD
- Filing Date
- 2023-12-04
- Publication Date
- 2026-06-16
AI Technical Summary
Traditional support caps in grooved stents can easily obstruct guidewires or external branch stents, affecting treatment outcomes.
Design a grooved bracket with a support cover made of braided yarns woven into a mesh structure. The mesh is deformable and the starting and ending ends of the weave are fixed by fasteners. The support cover is connected to the main bracket and a protective structure is provided to reduce the risk of obstruction.
This reduces the obstruction of the support cap to the guidewire and external branch stent, improving the effectiveness and safety of treatment and avoiding mechanical damage caused by welding.
Smart Images

Figure CN120093491B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a grooved support and its manufacturing method. Background Technology
[0002] Traditional open surgery for vascular diseases such as aortic aneurysms and aortic dissections is characterized by significant trauma, high mortality, long operation time, high postoperative complication rate, and high surgical difficulty. In contrast, minimally invasive interventional procedures offer advantages such as minimal trauma, high safety, and high effectiveness, thus gaining acceptance from both doctors and patients and becoming an important treatment method for vascular diseases. Interventional treatment involves implanting a vascular stent into the diseased segment of the blood vessel using a delivery system. The implanted stent expands to support the narrowed or occluded segment of the vessel or seals the tear in the dissection, reducing elastic recoil and remodeling of the vessel, maintaining unobstructed blood flow, and preventing further stenosis.
[0003] When an aneurysm or arterial dissection is located on the aorta near a branch vessel, a grooved stent can be implanted. The groove corresponds to the branch vessel, ensuring that blood from the aorta can flow through the groove into the branch vessel. This not only supports the narrowed or occluded segment of the vessel or seals the dissection opening but also maintains unobstructed blood flow to the branch. For vessels with true lumen stenosis or tortuosity, a support cap can be placed on the groove. The support cap provides good support and prevents the lumen from compressing the groove and thus the operating space. However, the support cap can easily obstruct the guidewire or external branch stent. Summary of the Invention
[0004] In view of the shortcomings of the above-mentioned technologies, the present invention provides a grooved bracket and its manufacturing method, which can reduce the obstruction of the support cover on the guide wire or external branch bracket to a certain extent.
[0005] This invention provides a grooved bracket, comprising:
[0006] The main support is tubular and has an inner cavity. The side of the main support is recessed towards the inner cavity to form a groove, and the groove includes a bottom.
[0007] A support cover is connected to the main body bracket, and at least a portion of the support cover and the bottom of the groove form a radial gap in the radial direction of the groove bracket. The support cover includes a mesh structure woven from braided yarns, the mesh structure including a plurality of deformable mesh holes, the mesh holes communicating the groove with the outside. The mesh structure includes a braiding start end and a braiding end end, the braiding start end and the braiding end end being fixed to each other by a fastener.
[0008] In one embodiment, the fastener is located at the radial edge and / or axial edge of the support cover.
[0009] In one embodiment, the groove includes an axial edge and a radial edge, and a corner is formed between the axial edge and the radial edge of the groove. The fastener includes a first axial end and a second axial end. The first axial end of the fastener is located at or near the corner of the groove, and the second axial end of the fastener is further away from the corner than the first axial end. The fastener is disposed along the radial edge of the groove.
[0010] In one embodiment, the support cover includes an edge bevel located at an axial end, the edge bevel including a vertex, the vertex of the edge bevel connecting to the corner of the groove, the fastener being disposed on the edge bevel, the fastener being adjacent to or near the vertex of the edge bevel.
[0011] In one embodiment, the edge bevel is connected to a hook unit, the hook unit including a first hook and a second hook that are axially movable relative to each other.
[0012] In one embodiment, the groove includes a radial edge having an inner wall, and the fastener is fixedly connected to the inner wall.
[0013] In one embodiment, the fastener is stitched to the inner wall by sutures, the sutures forming multiple stitching points on the outer surface of the fastener.
[0014] In one embodiment, the fixing member includes a fixing sleeve with an inner cavity. The braiding start end and the braiding end are fixed in the inner cavity. The braiding yarn segment adjacent to the braiding start end is designated as the first segment, and the braiding yarn segment adjacent to the braiding end is designated as the second segment. The first segment includes a first inner segment located within the fixing sleeve and a first outer segment connected to the first inner segment and located outside the fixing sleeve. The second segment includes a second inner segment located within the fixing sleeve and a second outer segment connected to the second inner segment and located outside the fixing sleeve. The first outer segment and / or the second outer segment are fixedly connected to the inner wall.
[0015] In one embodiment, along the circumference of the grooved bracket, the support cover includes a first mesh area and at least two second mesh areas respectively connected to both sides of the first mesh area; the second mesh area includes multiple spaced first direction support wires and multiple spaced second direction support wires, the first direction support wires and the second direction support wires overlapping each other to form multiple rows of cross units and multiple rows of deformable mesh holes, and at least one of the fixing members is disposed in the second mesh area.
[0016] In one embodiment, the groove includes a groove opening, and the axial distance between at least one of the fasteners and the proximal end of the groove opening is less than the axial distance between the fastener and the distal end of the groove opening; or, the axial distance between at least one of the fasteners and the proximal end of the groove opening is greater than the axial distance between the fastener and the distal end of the groove opening.
[0017] In one embodiment, when the axial distance between the fastener and the proximal end of the groove opening is less than the axial distance between the fastener and the distal end of the groove opening, the ratio of the axial distance between the fastener and the proximal end of the groove opening to the axial length of the groove opening is in the range of 5% to 15%; when the axial distance between the fastener and the proximal end of the groove opening is greater than the axial distance between the fastener and the distal end of the groove opening, the ratio of the axial distance between the fastener and the distal end of the groove opening to the axial length of the groove opening is in the range of 5% to 15%.
[0018] In one embodiment, the braiding start end and the braiding end are fixed in the fixing member, and the braiding start end and the braiding end are arranged opposite each other in the length direction of the braiding yarn, and the braiding start end and the braiding end are connected or spaced apart.
[0019] In one embodiment, the grooved bracket further includes one or more branch brackets connected to the main bracket, wherein all branch brackets are disposed within the main bracket, or at least some branch brackets are disposed outside the main bracket.
[0020] The present invention also provides a method for manufacturing a grooved bracket, characterized in that it includes:
[0021] Provide main frame and support cover;
[0022] Connect the support cover to the main bracket;
[0023] The method for manufacturing the support cover includes:
[0024] Provides braiding yarn,
[0025] The braided yarns are woven through multiple paths to form a mesh structure, the mesh structure including a braiding start end and a braiding end end;
[0026] The starting and ending ends of the braided yarn are fixed together by a fastener.
[0027] In one embodiment, the mesh structure is integrally woven from the braided yarns, and the mesh structure has only one braiding start end and one braiding end.
[0028] In one embodiment, the plurality of paths includes a plurality of first-direction paths and a plurality of second-direction paths, and the step of weaving the braided yarns through the plurality of paths to form a mesh structure includes:
[0029] Step A: Weave along the first directional path to form a first directional weave unit;
[0030] Step B: Weave along the second direction path to form a second direction weave unit;
[0031] Steps A and B are repeated alternately until a mesh structure is formed, wherein the first direction weaving unit and the second direction weaving unit are alternately formed and connected to each other, and at least one intersection point is formed between adjacent first direction weaving units and second direction weaving units.
[0032] The present invention also provides a grooved bracket, comprising:
[0033] The main support is tubular and has an inner cavity. The side of the main support is recessed towards the inner cavity to form a groove, and the groove includes a bottom.
[0034] A support cover is connected to the main support bracket, and at least a portion of the support cover and the bottom of the groove form a radial gap in the radial direction of the groove support bracket. The support cover can communicate the groove with the outside. A protective structure is provided on the surface of part or all of the support cover.
[0035] In one embodiment, the protective structure includes one or more protective layers selected from metal, polymer, ceramic, and composite material layers disposed on the surface of the support cover, wherein the composite material layer is made of one or more materials selected from metal, polymer, and ceramic.
[0036] In one embodiment, the mesh cover includes a mesh structure woven from braided filaments, the mesh structure including a plurality of mesh openings, the mesh structure including a plurality of overlapping points formed by the overlapping of the braided filaments, and at least at some of the overlapping points, the surface of the braided filaments is provided with a protective structure; and / or, the mesh openings are deformable mesh openings, and at least some of the inner walls of the mesh openings are provided with the protective structure.
[0037] In one embodiment, the mesh cover includes a mesh structure, the mesh structure includes a mesh body and side connectors disposed on the radial side of the mesh body, the surface of the mesh body is provided with a protective structure, and at least a portion of the side connectors are not provided with a protective structure.
[0038] In one embodiment, the protective structure includes a protective unit, and the support cover includes at least one row of hook units. Each hook unit includes a first hook and a second hook that hooks onto each other sequentially from the proximal end to the distal end. A hook gap is formed between the trough of the first hook and the crest of the second hook, so that the trough of the first hook and the crest of the second hook can move relative to each other in the axial direction. At least one hook unit is provided with the protective unit.
[0039] In one embodiment, the protective structure includes a first protective unit and / or a second protective unit, wherein the first protective unit is disposed on the side of the first hook member facing the hook gap at the trough, and the second protective unit is disposed on the side of the second hook member facing the hook gap at the crest.
[0040] In one embodiment, a first protective unit is provided on the side of the first hook member facing the hook gap, and a second protective unit is provided on the side of the second hook member facing the hook gap. The first and second protective units together shield part of the hook gap, and a through hole is formed between the first and second protective units. The trough of the first hook member and the crest of the second hook member can move axially in a direction away from each other to enlarge the through hole for insertion of the outer branch bracket. In the naturally unfolded state, the area of the through hole is smaller than the cross-sectional area of the outer branch bracket.
[0041] In one embodiment, the protective structure includes a protective unit, which includes one or more of a sheet-like structure, a strip-like structure, and a block-like structure.
[0042] In one embodiment, at least one of the first protection unit and the second protection unit includes a main body piece and an extension piece. Both the main body piece and the extension piece are sheet-like structures. One end of the main body piece is connected to the hook unit, and the other end extends into the hook gap and is connected to the extension piece. The extension piece has a free end and extends toward the bottom of the groove. The free end of the extension piece is located between the support cover and the bottom of the groove.
[0043] In one embodiment, at least one of the first protection unit and the second protection unit includes a sheet-like structure, and the sheet-like structure has a movable end, and the movable end includes a thin-walled region, the thickness of which is less than the thickness of other regions of the protection unit. When the outer branch bracket is inserted into the hook gap from the outside toward the direction close to the groove, at least a portion of the thin-walled region deforms relative to other regions of the sheet-like structure and extends toward the direction close to the bottom of the groove.
[0044] In one embodiment, the thin-walled region includes at least one crackable strip that cracks to form a rift when the outer branch bracket is inserted into the hook gap from the outside toward the bottom of the groove, and at least a portion of the thin-walled region adjacent to the rift deforms relative to other regions of the sheet structure and extends toward the bottom of the groove.
[0045] In one embodiment, the protective structure includes a first protective unit and a second protective unit, which together cover the hook gap; or, the protective structure includes a third protective unit, which includes a polymer film that completely covers one or more of the hook gaps, and the troughs of the first hook unit and / or the crests of the second hook unit are axially movable relative to each other, and at least a portion of the support cover is provided with insertion holes.
[0046] The beneficial effects of this invention are as follows: Compared with the prior art, the support cover of this invention includes a mesh structure woven from braided yarns. The mesh structure includes multiple deformable mesh holes, which can deform under external force to allow the guide wire and the outer branch support to pass through the mesh holes, thus reducing the obstruction of the support cover to the guide wire and the outer branch support. In addition, the braiding start end and braiding end of the mesh structure are fixed to each other by fasteners, which not only facilitates a stable connection between the braiding start end and the braiding end, but also avoids the risk of damage to the mechanical properties of the area near the braiding start end and the braiding end caused by welding. Attached Figure Description
[0047] Figure 1 This is a schematic diagram of the implantation state of the grooved stent of the present invention;
[0048] Figure 2 This is a schematic diagram of the grooved bracket according to Embodiment 1 of the present invention;
[0049] Figure 3 This is a schematic diagram of the groove structure in Embodiment 1 of the present invention;
[0050] Figure 4 This is a schematic diagram of the unfolded support cover according to an embodiment of the present invention;
[0051] Figure 5 This is a schematic diagram of the support cover unfolded according to another embodiment of the present invention;
[0052] Figure 6 This is a schematic diagram of the protective structure according to an embodiment of the present invention;
[0053] Figure 7 This is a schematic diagram of the protective structure according to another embodiment of the present invention;
[0054] Figure 8This is a perspective structural diagram of a support cover according to an embodiment of the present invention;
[0055] Figure 9 for Figure 8 Enlarged view of a portion of position A in the middle;
[0056] Figure 10 for Figure 8 Enlarged view of a portion of position B in the middle;
[0057] Figure 11 for Figure 8 Enlarged view of the middle C position;
[0058] Figure 12 for Figure 8 Enlarged view of a portion of position D;
[0059] Figure 13 This is a schematic diagram of the protective structure in another embodiment of the present invention;
[0060] Figure 14 This is a schematic diagram of the protective structure in another embodiment of the present invention;
[0061] Figure 15 This is a schematic diagram of the hook unit in one embodiment of the present invention;
[0062] Figure 16 This is a three-dimensional schematic diagram of the proximal region of a groove according to an embodiment of the present invention;
[0063] Figure 17 for Figure 16 Enlarged view of a portion of position E in the middle;
[0064] Figure 18 This is a schematic diagram of the protection unit in Embodiment 2 of the present invention;
[0065] Figure 19 for Figure 18 Diagram of the cutoff at FF;
[0066] Figure 20 This is a schematic diagram of the protection unit in Embodiment 3 of the present invention;
[0067] Figure 21 This is a schematic diagram of the protection unit in Embodiment 4 of the present invention;
[0068] Figure 22 This is a schematic diagram of the protection unit in another embodiment of the present invention;
[0069] Figure 23 This is a schematic diagram showing the position of the fixing member in the support cover in Embodiment 5 of the present invention;
[0070] Figure 24This is a schematic diagram of the braiding start end and braiding end end being fixed in the fixing member in Embodiment 5 of the present invention;
[0071] Figure 25 This is a schematic diagram showing the position of the fixing member in the support cover in another embodiment of the present invention;
[0072] Figure 26 This is a schematic diagram showing the position of the fixing member in the support cover in another embodiment of the present invention;
[0073] Figure 27 This is a schematic diagram of the fit between the fixing member and the groove in Embodiment 5 of the present invention;
[0074] Figure 28 This is a partially enlarged schematic diagram of the area where the fastener is located in Embodiment 5 of the present invention;
[0075] Figure 29 for Figure 28 A partially enlarged schematic diagram of the area where the central fastener is located;
[0076] Figure 30 This is a schematic diagram of the weaving path of the mesh structure in Embodiment 5 of the present invention;
[0077] Figure 31 This is a schematic diagram of the grooved bracket in one embodiment of the present invention;
[0078] Figure 32 This is a partial structural schematic diagram of a grooved bracket provided in an embodiment of the present invention;
[0079] Figure 33 This is a schematic diagram of the grooved bracket provided in an embodiment of the present invention. Detailed Implementation
[0080] To better understand the concept of the present invention, the embodiments of the present invention will be described in detail below with reference to the accompanying drawings. The following specific embodiments are only some embodiments of the present invention and are not intended to limit the present invention.
[0081] 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.
[0082] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end from which blood flows out, and "proximal" refers to the end from which blood flows in. For example, after stent implantation, blood flows from the proximal end of the stent toward the distal end; "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial" direction.
[0083] In this invention, the "wave loop" (also referred to as a waveform ring) is a closed ring structure, and the "wave unit" is an arc-shaped structure. The "wave loop" and "wave unit" are woven or cut from a metallic elastic material or a polymer material. This metallic elastic material includes known materials used in implanted medical devices or combinations of various biocompatible materials, such as alloys of two or more single metals selected from cobalt, chromium, nickel, titanium, magnesium, and iron, as well as 316L stainless steel, nickel-titanium-tantalum alloys, nitrided iron, iron-manganese alloys, sulfurized iron, carburized iron, etc., or other biocompatible metallic elastic materials. This metallic elastic material can be non-degradable or degradable. Polymer materials include blends or copolymers of one or more of the following monomers: polylactic acid, polyglycolic acid, polysuccinate, poly(β-hydroxybutyrate), polycaprolactone, polyadipate, ethylene glycol ester, polylactic acid-glycolic acid copolymer, polyhydroxybutyrate valerate copolymer, polyhydroxyalkyl alcohol ester, and poly(β-malate). They can also be biocompatible materials such as starch, cellulose, polysaccharides, chitin, chitosan, or their derivatives. Both the "wave loop" and "waveform unit" have radial expansion capabilities, allowing them to radially contract under external force and recover to their initial shape and maintain it after the external force is removed, either by self-expansion or mechanical expansion (e.g., balloon expansion). Thus, after implantation into the lumen, they can adhere tightly to the inner wall of the lumen through their radial support force. The waveform of the wave in the "wave loop" and "waveform unit" is unrestricted, including Z-shaped waves, M-shaped waves, V-shaped waves, sine waves, etc. Both "wave loops" and "waveform units" include multiple wave crests (also known as near-end vertices), multiple wave troughs (also known as far-end vertices), and wave rods connecting adjacent wave crests and troughs. Among them, a vertex (near-end vertex or far-end vertex) and two wave rods connected to that vertex form a wave.
[0084] The "coating" in this invention can isolate liquids to a certain extent, and it can be made of polymer materials with good biocompatibility, such as polytetrafluoroethylene (PTFE) and polyethylene terephthalate (PET).
[0085] Example 1
[0086] Please see Figure 1 In this embodiment, the grooved stent 100 is used for implantation into the target cavity. The target cavity can be any cavity within a living organism; the present invention does not limit the type of target cavity. For ease of understanding, the aortic arch 500 is used as an example of the target cavity in this illustration. (Refer to...) Figure 1The aortic arch 500 is connected to three branch vessels 200, which are located on the greater curvature side of the aortic arch 500. Blood flows from the aortic arch 500 to the branch vessels 200. An aneurysm 400 is formed on the lesser curvature side of the aortic arch 500 (this is for illustrative purposes only; in other cases, the aneurysm 400 may be located in other locations within the aortic arch 500). By implanting a grooved stent 100 into the aortic arch 500 to isolate the aneurysm 400, the blood flowing within the grooved stent 100 cannot come into contact with the aneurysm 400, ultimately achieving the goal of treating the aneurysm 400. An external branch stent 300 can also be implanted into the three branch vessels 200. This external branch stent 300 is connected to the grooved stent 100, and blood in the grooved stent 100 enters the branch vessels 200 through the external branch stent 300.
[0087] Please see Figure 2 and Figure 3 The grooved bracket 100 in this embodiment includes a main bracket 10 and a support cover 4 connected to the main bracket 10.
[0088] The main support 10 is a hollow tubular structure with openings at both ends. Its sides are recessed towards its inner cavity to form a groove 5. The groove 5 includes a bottom 51 and an opening 52. The opening 52 and the bottom 51 are radially opposite to each other in the groove support 100, with the opening 52 facing radially outward. A support cover 4 is connected to the groove 5, and at least a portion of the support cover 4 and the bottom 51 form a radial gap in the radial direction of the groove support 100. This radial gap communicates with the inner cavity of the main support 10. In this embodiment, the central angle corresponding to the projection of the support cover 4 onto the radial plane of the groove support 100 can be less than or equal to 180 degrees, for example, 120 degrees, to ensure that the support cover 4 has good radial support force and that there is sufficient space in the inner cavity of the main support 10 for blood flow. In other embodiments, the intermediate section 7 can be entirely recessed, with the support cover 4 tubularly fitted over the intermediate section 7.
[0089] For example, the main support 10 includes a main support portion and a main cover 31. The main cover 31 can be provided on the inner surface and / or the outer surface of the main support portion. For example, the main cover 31 can be provided only on the outer surface of the main support portion, or the main cover 31 can be provided on part or all of the inner surface of the main support portion and on part or all of the outer surface.
[0090] Please see Figure 2The main support 10 can be divided axially into a proximal segment 2, a distal segment 1, and an intermediate segment 7 located between the proximal segment 2 and the distal segment 1. The proximal segment 2 includes a tubular proximal support and a proximal main body covering. The proximal main body covering can be applied to the inner and / or outer surfaces of the proximal support by methods such as sewing, bonding, or heat fusion. The proximal support includes a plurality of axially spaced main body corrugations 101. The distal segment 1 includes a tubular distal support and a distal main body covering. The distal support includes a plurality of axially spaced main body corrugations 101. The distal main body covering can be applied to the inner and / or outer surfaces of the distal support by methods such as sewing, bonding, or heat fusion.
[0091] The intermediate segment 7 includes an intermediate main body film and an intermediate support portion 7a (which may be omitted in other embodiments). The inner cavity formed by the intermediate main body film 31 communicates with the inner cavities formed by the proximal main body film and the distal main body film. The intermediate support portion 7a includes a plurality of arc-shaped wave units arranged at intervals in the axial direction, and the openings of the arc-shaped wave units face the direction of the groove 5. The main body support 10 is recessed on the side of the intermediate segment 7 towards the inner cavity of the main body support 10 to form a groove 5. The projection of the edge of the groove 5 onto the plane passing through its radial edges is approximately rectangular (or the opening of the groove 5 is approximately rectangular). In other embodiments, the groove 5 may be of other shapes. Part of the intermediate main body film serves as the bottom film of the groove bottom 51, and the groove bottom 51 may also be provided with a bottom support member. The bottom support member may include one or more of wave units and mesh structures. Understandably, the bottom support member may be omitted.
[0092] The two radial sides of the support cover 4 are fixedly connected to the central main body film by means of stitching, bonding, heat fusion, etc., and at least a part of the support cover 4 forms a radial gap (or gap, void, cavity) with the outer surface of the bottom of the groove 51. An inner branch bracket 6 can be provided in the proximal section 2 and / or the distal section 1. The inner cavity of the inner branch bracket 6 communicates with the inner cavity of the main body bracket 10 and with the radial gap formed between the bottom of the groove 51 and the support cover 4. Multiple inner branch brackets 6 can be provided. For example, inner branch brackets 6 are provided at the proximal position near the groove 5 and at the distal position near the groove 5.
[0093] Please see Figure 2 and Figure 4In one embodiment, the support cover 4 has an arcuate structure in the circumferential direction of the grooved support 100. The support cover 4 includes a mesh structure 4a woven from braided filaments 40. The mesh structure 4a includes a mesh body 4b and side connectors 46 disposed on the radial sides of the mesh body 4b. The mesh structure 4a is connected to the main support 10 via the side connectors 46 (e.g., fixed connection). The mesh structure 4a includes a plurality of overlapping points (or crossing points) formed by the overlapping (or crossing) of the braided filaments 40. At these overlapping points, the braided filaments 40 can slide relative to each other. The mesh structure 4a also includes a plurality of deformable mesh openings communicating with the outside world to facilitate the insertion of guide wires and external branch supports 300. The support cover 4 can be integrally woven from braided filaments made of shape memory alloy or other materials, or it can be woven separately and then spliced together. In other embodiments, the mesh structure 4a of the support cover 4 can also be formed by cutting; or, in other embodiments, the support cover 4 may not include the mesh structure 4a, but may include a hollow structure with through holes, or other structures with through holes, such as a structure formed by multiple wavy rings spaced apart in the axial direction.
[0094] Please also refer to 6. At least a portion of the surface of the support cover 4 is provided with a protective structure 70. For example, at least a portion of the surface of the braided filaments 40 of the support cover 4 is provided with a protective structure 70. The protective structure 70 includes one or more protective layers 71 selected from metal layers, polymer layers, ceramic layers, and composite material layers. The composite material layer can be made of one or more of metals, polymers, and ceramics. For the metal layer, it can be formed on the surface of the support cover 4 by electroplating, brush plating, physical or chemical deposition, sputtering, spraying, coating, laser deposition, etc. The metal layer can be made of one or more metal materials such as titanium and its alloys, tantalum and its alloys, zirconium and its alloys, niobium and its alloys, zinc alloys, magnesium alloys, iron and its alloys, tungsten and its alloys, platinum and its alloys, gold and its alloys, etc. For the polymer layer, the polymer raw material can be covered to the surface of the support cover 4 to form a film by coating, spraying, spin coating, fusion coating, dip coating, etc., or the polymer film layer can be wrapped to the surface of the braided filaments 40 by sewing, gluing, hot melting, etc., or any other suitable method to set the polymer layer on the surface of the braided filaments 40. The polymer layer can be selected from one or more of PTFE, PET, ePTFE (Expanded Polytetrafluoroethylene), FEP (Fluorinated ethylene propylene), L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic-co-hydroxyacetic acid copolymer, polyhydroxy fatty acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate ester, polyglycolic acid, and polydioxanone. In other embodiments, the polymer layer can also be selected from any other suitable material. The ceramic layer can be made of any known ceramic material suitable for human use, and can be deposited on the surface of the support cover 4 by electroplating, coating, spraying, fusion coating, or any other suitable method. By providing a protective structure 70 on the surface of the braided filaments 40 in at least a portion of the support cover 4, it is beneficial to reduce the probability of mechanical property damage to the braided filaments 40 in at least a portion of the support cover 4 due to wear.
[0095] In this embodiment, the surface of the braided filaments 40 of the mesh body 4b is provided with a protective structure 70. For example, refer to... Figure 7During fabrication, strips 711 (e.g., PTFE strips) are wound around the surface of the braided filaments 40 in the mesh body 4b. For example, the strips 711 can be spirally wound around the surface of the braided filaments 40 to completely cover the surface of the braided filaments 40 in the mesh body 4b. Next, the support cover 4 with the strips 711 wound around it is heat-treated to fuse the strips 711 to the surface of the braided filaments 40. In other embodiments, a bioceramic layer can be electroplated onto the surface of the braided filaments 40 in the mesh body 4b as a protective structure 70. In other embodiments, other materials can be used for the protective structure 70, and other suitable methods can be used to set the protective layer 71.
[0096] This arrangement ensures that protective structures 70 are provided at the overlapping points of all braided wires 40 in the mesh body 4b and on the inner walls of all mesh openings. This not only reduces the risk of damage to the braided wires 40 at their overlapping points where they are prone to friction, but also helps protect the mesh openings and the external branch supports 300 inserted into them. It can reduce the risk of damage to the mesh openings or external branch supports 300 caused by friction between the mesh openings and the inserted external branch supports 300. In other embodiments, the mesh body 4b may only have protective structures 70 partially provided. For example, only at some or all of the overlapping points of the braided wires 40, the surface of the braided wires 40 may have protective structures 70, while the inner walls of the mesh openings may not have protective structures 70; or, only at some or all of the inner walls of the mesh openings may have protective structures 70, while the overlapping points of the braided wires 40 may not have protective structures 70; or, only at some of the overlapping points of the braided wires 40, the surface of the braided wires 40 may have protective structures 70, and the inner walls of some mesh openings may also have protective structures 70.
[0097] In this embodiment, the protective structure 70 is not provided in part or all of the side connector 46 of the support cover 4. For example, the side connector 46 is fixedly connected to the main support 10, for instance, by stitching it to the main body film 31 of the main support 10. Therefore, the relative position between the side connector 46 and the main support 10 is relatively fixed, with less relative movement and a lower probability of relative friction. Thus, at least a portion of the side connector 46 may not have the protective structure 70. Furthermore, if the protective structure 70 is provided on the surface of the side connector 46 with a surface smoothness higher than that of the bare side connector 46, and the side connector 46 is stitched to the main support 10, it is easy for relative slippage to occur between the side connector 46 and the main support 10, thereby causing relative displacement between the support cover 4 and the main support 10. Therefore, not providing the protective structure 70 on the side connector 46 also helps to reduce the probability of relative displacement between the support cover 4 and the main support 10. Furthermore, there is a step between the bare area on the side connector 46 and the area with the protective structure 70 on the adjacent surface, which can limit the stitches used to sew the side connector 46 and the main support 10, thereby further reducing the probability of relative displacement between the support cover 4 and the main support 10.
[0098] For example, refer to Figure 8 and Figure 9 In this embodiment, the side connector 46 is roughly triangular, including two waists 461, a base 462 connecting the two waists 461, and a connecting hole 46a formed by the waists 461 and the base 462. The connecting hole 46a can serve as a suture hole for fixed connection with the membrane or the main body 10 by sewing. The connecting hole 46a not only facilitates sewing operations but also serves as a limiting function, reducing relative slippage between the suture and the support cover 4. In this embodiment, the connecting hole 46a is a closed (or closed-loop) hole, which is beneficial for further improving the limiting effect. In other embodiments, the connecting hole 46a can be an open hole. In other embodiments, the connecting hole 46a may not be used as a suture hole, and the side connector 46 can also be connected to the main body support 10 by bonding, heat fusion, or other methods.
[0099] The bottom edge 462 of the side connector 46 extends approximately axially and connects to the radial edge of the groove 5. The two waists 461 of the side connector 46 intersect to form a apex, where they overlap. The bottom edge 462 can be connected to the edge of the groove 5 by stitching or bonding. The overlapping area of the two waists 461 can slide relative to each other, which helps to further increase the expansion size of the mesh on the side of the support cover 4. A protective structure 70 can be provided at the overlapping area of the two waists 461 to reduce the risk of damage caused by mutual friction. In other embodiments, the overlapping area of the two waists 461 can be fixed to each other, for example, by stitching. This connection method allows for better stability on both radial sides of the support cover 4, thereby ensuring the overall support force of the support cover 4 after connection, while reducing the risk of damage caused by mutual friction at the overlapping area of the two waists 461. In another embodiment, protective structures 70 can be provided on the surfaces of both waists 461, while no protective structure 70 can be provided on the bottom edge 462. The bottom edge 462 is stitched to the edge of the groove 5. The two waists 461 with protective structures 70 can better confine the seam to the bottom edge 462, which can better reduce the probability of large relative displacement between the side connector 46 and the main support 10. In other embodiments, the side connector 46 can be other shapes. For example, the side connector 46 can also be teardrop-shaped, circular, elliptical, or any other suitable shape.
[0100] The structure of the support cover 4 of the present invention can be varied, and those skilled in the art can choose according to the actual application scenario. The following is an example of the structure of the support cover.
[0101] Please see Figure 4 The support cover 4 includes a first mesh region 41, which includes at least one row of hook units 47. Each row of hook units 47 includes multiple hook units 47 arranged axially in sequence. Each hook unit 47 includes a first hook 471 and a second hook 472, both formed by bending braided yarns 40. The first hook 471 includes a wave bulging towards the distal end, namely, a trough 4711 (also called the distal vertex) and two first wave rods 4712 connected to the trough 4711. The second hook 472 includes a wave bulging towards the proximal end, namely, a crest 4721 (also called the proximal vertex) and two second wave rods 4722 connected to the crest 4721. In this embodiment, the first hook 471 and the second hook 472 of each hook unit 47 are hooked to each other approximately axially. It should be noted that "approximately along the axial direction" here means that the line connecting the far vertex of the first hook 471 and the near vertex of the second hook 472 is approximately parallel to the axis of the support cover 4, or the angle between the line connecting the two is less than or equal to 45°.
[0102] In its naturally unfolded state, the first hook 471 and the second hook 472 hook each other, and there is a hook gap G (i.e., a distance between them) between the troughs 4711 of the first hook 471 and the crests 4721 of the second hook 472. Therefore, the first hook 471 can move towards the proximal or distal end, and the second hook 472 can also move towards the proximal or distal end. However, the hook gap G limits the distance that the first hook 471 can move towards the proximal end and the second hook 472 can move towards the distal end. It can be understood that the hook gap G can serve as a mesh opening of the mesh structure 4a, which can be expanded under the action of external force to allow the guide wire or the external branch support 300 to be inserted into it.
[0103] Reference Figure 4 , Figure 13 In this embodiment, the protective structure 70 further includes a protective unit 72. At least one hook unit 47 is provided with a protective unit 72, which can be fixedly connected to the hook unit 47 by means of sewing, gluing, heat fusion, etc. Since the area of the hook gap G is smaller than the area of other meshes (other types of meshes besides the hook gap G) in the mesh structure 4a, if the guide wire enters from the hook gap G and guides the outer branch support 300 to be inserted therein, the inserted outer branch support 300 may be subjected to a large compressive force from the hook gap G, and the friction between the two may be large. By providing a protective unit 72 on the inner wall of the hook gap G, it is beneficial to reduce the probability of the outer branch support 300 being damaged by compression and friction. It can be understood that in other embodiments, only the protective unit 72 may be provided without the protective layer 71, or only the protective layer 71 may be provided without the protective unit 72.
[0104] For example, the protective structure 70 further includes a first protective unit 721 and a second protective unit 722. The first protective unit 721 is located on the side of the first hook 4711 facing the hook gap G, and the second protective unit 722 is located on the side of the second hook 4721 facing the hook gap G. The first protective unit 721 and the second protective unit 722 can jointly shield at least part of the hook gap G, thereby reducing the probability that the guide wire passes through the hook gap G and guides the outer branch support 300 to be inserted from the hook gap G. Even if the outer branch support 300 is inserted from the hook gap G and connected to the corresponding inner branch support 6, the first protective unit 721 and the second protective unit 722 can still effectively protect the hook unit 47 and the outer branch support 300 during subsequent use, and can improve the process of the inner skin of the support cover 4. Therefore, the risk of damage to the outer branch support 300 caused by friction and cutting forces between the two can be reduced. When the first protection unit 721 and the second protection unit 722 only jointly cover part of the hook gap G, a through hole 723a can be formed between the first protection unit 721 and the second protection unit 722. The trough 4711 of the first hook 471 and the crest 4721 of the second hook 472 can move axially in a direction away from each other to enlarge the through hole, allowing the outer branch support 300 to be inserted. In the naturally unfolded state, the area of the through hole 723a is smaller than the cross-sectional area of the outer branch support 300. In other embodiments, the first protection unit 721 and the second protection unit 722 can completely cover the hook gap G. For example, the adjacent edges of the first protection unit 721 and the second protection unit 722 may fit together, or there may be an overlapping area between the first protection unit 721 and the second protection unit 722, which together completely seal the hook gap G to prevent the guide wire and the outer branch support 300 from being inserted into the hook gap G.
[0105] The first protection unit 721 and the second protection unit 722, etc., the protection unit 72 includes one or more of the following structures: sheet-like structure, strip-like structure, and block structure. (Refer to...) Figure 13In this embodiment, both the first protection unit 721 and the second protection unit 722 include sheet-like structures. These sheet-like structures can be made of one or more polymeric materials selected from PTFE, PET, ePTFE, FEP, L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic-co-hydroxyacetic acid copolymer, polyhydroxy fatty acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate ester, polyglycolic acid, and polydioxanone. For example, the first protection unit 721 includes a first sheet-like structure 7211, and the second protection unit 722 includes a second sheet-like structure 7221. The first sheet-like structure 7211 and the second sheet-like structure 7221 together shield at least a portion of the hook gap G. One end of the first sheet structure 7211 is fixedly connected to the trough 4711 of the first hook 471 and the area of the two first wave rods 4712 near the trough 4711, and the other end extends toward the area of the second hook 472; one end of the second sheet structure 7221 is fixedly connected to the crest 4721 of the second hook 472 and the area of the two second wave rods 4722 near the crest 4721, and the other end extends toward the area of the first hook 471. The aforementioned sheet-like structure helps to better shield the hook gap G, reducing the probability of the outer branch support 300 being inserted into the hook gap G. Furthermore, the sheet-like structure can, to a certain extent, prevent the outer branch support 300 inserted into the hook gap G from being squeezed into a narrow space near the trough 4711 of the first hook 471 and the crest 4721 of the second hook 472, thus preventing excessive deformation. The sheet-like structure also provides good cushioning, effectively reducing the risk of damage to the outer branch support 300 caused by friction and cutting forces between the outer branch support 300 and the hook unit 47. When the sheet-like structure is made of a biodegradable material, after the subsequent endothelialization of the grooved support and the outer branch support 300, the sheet-like structure can gradually degrade and be absorbed by the body, thereby providing a larger accommodating space for the inserted outer branch support 300.
[0106] In this embodiment, a through hole 723a is formed between the end of the first sheet structure 7211 further away from the trough 4711 and the end of the second sheet structure 7221 further away from the crest 4721. The edge of the end of the first sheet structure 7211 further away from the trough 4711 is roughly curved in an arc shape towards the trough 4711, and the edge of the end of the second sheet structure 7221 further away from the crest 4721 is roughly curved in an arc shape towards the crest 4721, so that the through hole 723a between the first sheet structure 7211 and the second sheet structure 7221 is roughly olive-shaped. The olive-shaped through hole 723a has a larger size in the radial direction (or transverse direction) of the support cover 4 than in the axial direction of the support cover 4. Even if the outer branch bracket 300 is inserted into it, it can confine the outer branch bracket 300 to the area with a larger radial size, avoiding excessive deformation caused by the outer branch bracket 300 being squeezed into the narrow space near the trough 4711 of the first hook 471 and the crest 4721 of the second hook 472. In addition, the arc-shaped edges of the first sheet structure 7211 and the second sheet structure 7221 can provide guidance for the relative movement of the first hook 471 and the second hook 472, avoiding damage to the inner wall of the tissue caused by the crest 4721 when the groove bracket 100 bulges and bends in the direction of the groove 5 due to the deviation of the hook position.
[0107] In this embodiment, both the maximum radial dimension and the maximum axial dimension of the through hole 723a are greater than the diameter of the guide wire. The maximum radial dimension refers to the maximum length of the line connecting the two radial endpoints of the through hole 723a along the radial direction (or transverse direction) of the groove 5, and the maximum axial dimension refers to the maximum length of the line connecting the two axial endpoints of the through hole 723a along the axial direction of the groove 5. The guide wire referred to here is the guide wire that guides the outer branch bracket 300 into the inner branch bracket 6. The advantage of having both the maximum radial and axial dimensions of the through hole 723a greater than the diameter of the guide wire is that it provides space for relative movement of the first hook 471 and the second hook 472, giving the support cover 4 better bending performance. In other embodiments, at least one of the maximum radial and axial dimensions of the through hole 723a is smaller than the diameter of the guide wire. This arrangement helps to prevent the guide wire from entering the through hole 723a, thereby reducing the probability of the outer branch bracket 300 being inserted into it. In other embodiments, a through hole 723a may not be formed between the first sheet structure 7211 and the second sheet structure 7221, but they may together completely cover the hook gap G.
[0108] Reference Figure 14In other embodiments, both the first protection unit 721 and the second protection unit 722 include strip-shaped structures. For example, the first protection unit 721 includes a first strip-shaped structure 7212, and the second protection unit 722 includes a second strip-shaped structure 7222. The first strip-shaped structure 7212 and the second strip-shaped structure 7222 together shield at least part of the hook gap G and divide the hook gap G into multiple through holes 723a. The two ends of the first strip-shaped structure 7212 along its length are respectively connected to the two first wave rods 4712 of the first hook member 471, and the two ends of the second strip-shaped structure 7222 along its length are respectively connected to the two second wave rods 4722 of the second hook member 472. The first strip-shaped structure 7212 and the second strip-shaped structure 7222 may extend approximately parallel or non-parallel. The aforementioned strip structure helps reduce the probability of the outer branch bracket 300 being inserted into the hook gap G. Furthermore, the strip structure can, to a certain extent, prevent the outer branch bracket 300 inserted into the hook gap G from being squeezed into a narrow space near the trough 4711 of the first hook 471 and the crest 4721 of the second hook 472, thus preventing excessive deformation and providing better cushioning. Therefore, it can effectively reduce the risk of damage to the outer branch bracket 300 caused by friction and cutting forces between the outer branch bracket 300 and the hook unit 47. The strip structure also imposes less restriction on the relative movement between the first hook 471 and the second hook 472, allowing for more flexible relative movement and thus better maintaining the bending performance of the support cover 4. Simultaneously, the strip structure is also easier to fold radially, making the support cover 4 easier to compress radially without exceeding its original size. When the strip structure is made of a biodegradable material, after the strip structure degrades and breaks, part of the remaining structure extends into the radial gap between the support cover 4 and the groove 5, which helps to accelerate the endothelialization process in the area of the support cover 4. After endothelialization, the support cover 4 and the outer branch support 300 can form a relatively integrated structure. Therefore, it can further reduce the risk of damage to the outer branch support 300 caused by friction and cutting force between the outer branch support 300 and the hook unit 47.
[0109] Understandably, in other embodiments, the first protection unit 721 and the second protection unit 722 may each adopt different structures. For example, the first protection unit 721 may include a sheet-like structure, while the second protection unit 722 may include a strip-like structure, or vice versa. When the first protection unit 721 and the second protection unit 722 can each adopt different structures, the advantages of multiple structures can be combined. In other embodiments, the number of protection units 72 in the hook gap G may be one; for example, one of the first protection unit 721 and the second protection unit 722 may be omitted. In other embodiments, the number of protection units 72 in the hook gap G may be greater than two.
[0110] Further, please refer to Figure 15In this embodiment, both the trough 4711 of the first hook 471 and the peak 4721 of the second hook 472 include a crossbar 473. The two first wave rods 4712 of the first hook 471 are connected by the crossbar 473, and the two second wave rods 4722 of the second hook 472 are connected by the crossbar 473. The crossbar 473 helps to further enlarge the size of the mesh formed by the hook gap G, making the hook gap G more suitable as a mesh for the external branch stent 300 to enter. In addition, without the crossbar 473, the two wave rods are directly connected, and the wave angle of the peak 4721 or trough 4711 formed by the connection is relatively sharp. When the support cover 4 bends with the tubular stent, it will lift up on the bending surface. Under long-term use, the wave angle will scratch the inner wall of the blood vessel, causing unnecessary damage. Therefore, the crossbar 473 can reduce the risk of scratching the inner wall of the blood vessel.
[0111] In this embodiment, the angle formed by the crossbar 473 and the first wave bar 4712 and / or the second wave bar 4722 is an obtuse angle to further enlarge the size of the mesh formed by the hook gap G. The length of the crossbar 473 should be appropriate, ranging from 1 mm to 4 mm. This not only expands the area of the hook gap G and protects the inner wall of the blood vessel, but also avoids the problem of excessive radial compression of the support cover 4 due to an excessively long crossbar 473. In this embodiment, the crossbar 473 is a straight bar, which can directly and effectively avoid scratching the blood vessel wall. When using a straight bar, a rounded transition is used when connecting the straight bar to the two wave bars. In other embodiments, the crossbar 473 can also be an arc-shaped bar with a smaller degree of curvature, preferably ranging from 60° to 140°.
[0112] Please see Figure 4 In this embodiment, the support cover 4 further includes a second mesh region 42 connected to the first mesh region 41. Both the first mesh region 41 and the second mesh region 42 can radially contract under the action of external force, and after the external force is removed, they can self-expand or mechanically expand (e.g., by balloon expansion) to return to and maintain their initial shape. Preferably, along the circumference of the grooved support 100, the support cover 4 includes a second mesh region 42 and two first mesh regions 41 respectively connected to the radial sides of the second mesh region 42.
[0113] The second mesh region 42 includes multiple spaced-apart first-direction support wires 481 and multiple spaced-apart second-direction support wires 482, both of which are braided wires 40. The first-direction support wires 481 extend generally along the first direction, and the second-direction support wires 482 extend generally along the second direction. The first-direction support wires 481 and the second-direction support wires 482 overlap (or interweave) to form multiple rows of mesh openings and multiple rows of cross units 48. Each row of mesh openings includes multiple mesh openings arranged generally along the axial direction. Each row of cross units 48 includes multiple cross units 48 arranged generally along the axial direction. The mesh openings are generally rhomboid, but can also be square, rectangular, or other shapes; four cross units 48 are correspondingly arranged at the four corners of the mesh openings. Each cross unit 48 includes an intersection point formed by the overlap of the first-direction support wires 481 and the second-direction support wires 482, at which the first-direction support wires 481 and the second-direction support wires 482 can move relative to each other. In some of the cross units 48, the first directional support wire 481 is located outside the second directional support wire 482, and in others, it is located inside the second directional support wire 482. In other embodiments, the first directional support wires 481 in the second mesh region 42 are all located outside the second directional support wire 482, or all of them are located inside the second directional support wire 482. Because the first directional support wires 481 and second directional support wires 482 at the intersection points of the cross units 48 overlap and can move relative to each other, the mesh openings in the second mesh region 42 can deform and enlarge under external force to facilitate the passage of the guide wire and the external branch stent 300 through the mesh openings. When the external force is removed, the mesh openings can retract to provide some support and limit for the external branch stent 300, reducing the likelihood of the external branch stent 300 swaying with blood flow or heartbeat, thus ensuring the stability of branch blood supply.
[0114] Please see Figure 4 The support cover 4, in the axial direction from the proximal end to the distal end, includes a proximal cover 43 and a distal cover 45. Please also refer to... Figures 8 to 12When the first hook 471 hooks with the second hook 472 to form a hook unit 47, the hook unit 47 in the proximal cover 43 is different from the hook unit 47 in the distal cover 45. In the proximal cover 43, the first wave rod 4712 in the same hook unit 47, which is near the radial edge of the support cover 4, crosses over the second wave rod 4722; and / or, in the distal cover 45, the second wave rod 4722 in the same hook unit 47, which is near the radial edge of the support cover 4, crosses over the first wave rod 4712. The term "above" refers to the side further away from the inner cavity of the main support 10, which can also be understood as the outer side of the arched structure of the support cover 4. The reason for this arrangement is that if the outer branch support 300 enters the groove 5 through the mesh on the proximal cover 43 and then connects to the inner branch support 6 located in the proximal segment 2, the first wave rod 4712 in the same hook unit 47 near the radial edge of the support cover 4 crosses over the second wave rod 4722 in the proximal cover 43. Therefore, the first wave rod 4712 can be separated from the second wave rod 4722 located below it in the radial direction of the groove support 100, thus having better upward deformation capability and space. This allows the mesh on the radial side of the proximal cover 43 to undergo greater deformation under external force, expanding large enough to facilitate the guide wire and the outer branch support 300 to pass through the mesh. When the external force is removed, the mesh can retract to provide some support and limit for the outer branch support 300, reducing the occurrence of the outer branch support 300 swinging with blood or heartbeat, and ensuring the stability of branch blood supply. Conversely, if the second wave rod 4722 crosses over the first wave rod 4712 at this position, the first wave rod 4712 will be restricted by the second wave rod 4722 above it, making it difficult to lift further. As a result, the first hook 471 and the second hook 472 will be twisted together at the hook position, which is not conducive to the expansion and deformation of the mesh opening, thus affecting the entry of the outer branch support 300.
[0115] In the distal end cover 45, the second wave rod 4722 in the same hook unit 47, near the radial edge of the support cover 4, crosses over the first wave rod 4712; the principle and effect of this structure are similar to those of the proximal end cover 43, and will not be described again here.
[0116] It is understood that in order to make the mesh on the radial side of the support cover 4 easy to expand and deform, it is not required that the structure of the second mesh region 42 be the same as that described in this embodiment. In other embodiments, the structure of the second mesh region 42 may be similar to that of the first mesh region 41 in this embodiment, including at least one row of hook units 47, or the structure of the second mesh region 42 may be any other suitable structure.
[0117] Please see Figure 4Furthermore, in one embodiment, the first wave rod 4712 and the second wave rod 4722 of the hook unit 47 near the radial edge of the support cover 4 form an axial gap, and the maximum axial length of the axial gap formed by the same row of hook units 47 can be equal or unequal. Exemplarily, in this embodiment, the maximum axial length of the axial gap formed by the same row of hook units 47 is unequal. For example, the multiple axial gaps formed between the multiple hook units 47 include end gaps and intermediate gaps, with the end gaps being closer to the axial ends of the support cover 4 than the intermediate gaps, and the maximum axial length of at least one end gap ( Figure 4 The L1 shown is greater than the maximum axial length of the intermediate interval ( Figure 4 As shown in L2), for example, the maximum axial length of the end spacing near the proximal end of the support cover 4 is greater than the maximum axial length of the intermediate spacing, and the maximum axial length of the end spacing near the distal end of the support cover 4 is greater than the maximum axial length of the intermediate spacing. In other embodiments, if the inner branch support 6 is provided only near one axial end of the support cover 4, then it is sufficient that the maximum axial length of the end spacing near that axial end is greater than the maximum axial length of the intermediate spacing. The axial end of the support cover 4 is opposite to the edge of the inner branch support 6, so the probability of the outer branch support 300 entering the inner branch support 6 from the mesh near the axial end of the support cover 4 is relatively high. By setting the maximum axial length L1 of the end spacing to be greater than the maximum axial length L2 of the intermediate spacing, the size of the side mesh near the axial end of the support cover 4 is further increased, which facilitates the entry of the guide wire and the outer branch support 300. Understandably, to achieve easy expansion and deformation of the mesh on the radial side of the support cover 4, it is not necessarily required that the maximum axial length L1 of the end interval be greater than the maximum axial length L2 of the middle interval. The maximum axial length L1 of the end interval can be approximately equal to the maximum axial length L2 of the middle interval. As long as the first wave rod 4712 of the same hook unit 47 near the radial edge of the support cover 4 in the near end cover 43 crosses over the second wave rod 4722; and / or, the second wave rod 4722 of the same hook unit 47 near the radial edge of the support cover 4 in the far end cover 45 crosses over the first wave rod 4712, the effect of easy expansion and deformation of the mesh on the radial side of the support cover 4 can be achieved.
[0118] Reference Figure 4All side connectors 46 are connected to hook units 47. For example, side connectors 46 are connected to two axially adjacent hook units 47 respectively. In the adjacent hook units 47, the second wave rod 4722 in the second hook member 472 of the hook unit 47 closer to the near end of the groove bracket 100 continues to extend and bend to form a connecting hole 46a, and then connects to the first wave rod 4712 of the first hook member 471 of the hook unit 47 closer to the far end of the groove bracket 100. The first wave rod 4712 and the second wave rod 4722 are both wave rods in the hook unit 47 that are closer to the radial side of the support cover 4.
[0119] Reference Figure 4 , Figure 8 In this embodiment, the support cover 4 further includes a side end connector 42a disposed at the axial end of the support cover 4. For example, both the distal and proximal ends of the support cover 4 are provided with side end connectors 42a, which are used to connect with the edge of the groove 5. The aforementioned side connector 46 is disposed between the side end connector 42a at the distal end of the support cover 4 and the side end connector 42a at the proximal end of the support cover 4, and the side end connectors 42a and 46 are spaced apart. By providing the side end connector 42a, the support cover 4 can better follow the bending deformation of the main body stent 10 to better fit the blood vessel and provide support for the groove 5. Furthermore, in this embodiment, the side end connector 42a includes an edge bevel 421 that protrudes towards the axial end of the support cover 4. This edge bevel 421 connects the connector to the main support 10, for example, by stitching or bonding. Since the apex 4211 of the edge bevel 421 does not form a closed connection hole structure, it not only reduces the sheath size at the corner of the support cover 4 but also allows the edge bevel 421 and the adjacent hook unit 47 to form a large polygonal mesh. The large size of this polygonal mesh facilitates the entry of the guide wire and the outer branch support 300 through the mesh. In other embodiments, the side end connector 42a may be omitted.
[0120] When the maximum axial length of at least one end gap is greater than the maximum axial length of the middle gap, since the side end connector 42a is connected to the hook unit 47, the maximum gap distance between the side end connector 42a and its adjacent side connector 46 is also greater than the maximum gap distance between two adjacent side connectors 46. This is beneficial for increasing the size of the side mesh near the axial end of the support cover 4, facilitating the entry of the guide wire and the outer branch bracket 300. In other embodiments, the maximum gap distance between the side end connector 42a and its adjacent side connector 46 may also be approximately equal to the maximum gap distance between two adjacent side connectors 46.
[0121] In another embodiment, reference is made to Figure 5The plurality of side connectors 46 include two first side connectors 46a and a second side connector 46b located between the two first side connectors 46a. The second side connector 46b is connected to a first hook 471 and a second hook 472, respectively. The first side connector 46a is axially connected to the side end connector 42a and the hook unit 47, respectively. For example, the first side connector 46a near the near end of the support cover 4 is axially connected to the side end connector 42a and the first hook 471 located near the near end of the support cover 4, respectively. For example, in the first hook 471 of the hook unit 47 at the nearest end, the first wave rod 4712 near the radial edge of the support cover 4 continues to extend towards the near end of the support cover 4, and then bends in the opposite direction to form the first side connector 46a and connects to the side end connector 42a located near the near end of the support cover 4; the first side connector 46a near the far end of the support cover 4 is axially connected to the side end connector 42a and the second hook 472 located at the far end of the support cover 4, respectively. For example, in the second hook 472 of the hook unit 47 at the farthest end, the second wave rod 4722 near the radial edge of the support cover 4 (also refer to Figure 4 ) Continuing to extend towards the far end of the support cover 4, it then bends in the opposite direction to form the first side connector 46a and connects to the side end connector 42a located at the far end of the support cover 4. In this embodiment, the side end connector 42a includes an edge bevel 421 that protrudes towards the axial end of the support cover 4. The edge bevel 421 and the adjacent hook unit 47 form a polygonal mesh. The polygonal mesh has a large size, which facilitates the entry of the guide wire and the outer branch support 300 through the mesh. Furthermore, since the side end connector 42a is connected to the first side connector 46a in this embodiment, and there is a gap between the first side connector 46a and the vertex 4211 of the edge bevel 421 of the end connector, it not only does not increase the sheath size of the corner of the support cover 4, but also ensures that a larger mesh is formed between the side end connector 42a and the adjacent hook unit 47. It also prevents the edge bevel 421 fixed by sewing from shifting relative to the groove 5 and piercing out and damaging biological tissue when the support cover 4 is pressed or deformed.
[0122] In this embodiment, when the maximum axial length of at least one end gap is greater than the maximum axial length of the middle gap, the maximum gap distance between the first side connector 46a and the adjacent second side connector 46b is also greater than the maximum gap distance between two adjacent second side connectors 46b. This is beneficial for increasing the size of the side mesh holes of the support cover 4 near its axial end, facilitating the entry of the guide wire and the outer branch bracket 300. In other embodiments, the maximum gap distance between the first side connector 46a and the adjacent second side connector 46b can also be approximately equal to the maximum gap distance between two adjacent second side connectors 46b.
[0123] Please see Figure 4 , Figure 8 , Figure 12 In this embodiment, the support cover 4 also includes a bent portion 422, which includes a first rod 4222 and a second rod 4223 connected to each other. A bending angle 4221 is formed between the first rod 4222 and the second rod 4223. The first rod 4222 extends from the bending angle 4221 toward one axial end of the support cover 4, and the second rod 4223 extends from the bending angle 4221 toward the other axial end of the support cover 4. Since the first rod 4222 and the second rod 4223 of the bent portion 422 extend toward opposite axial ends of the support cover 4, relative to the straight rod, when the support cover 4 is subjected to radial compression from the blood vessel wall and bends to conform to the shape of the blood vessel, the first rod 4222 and the second rod 4223 forming the bending angle 4221 can move relative to each other, so that the bent portion 422 can bulge toward a direction away from the groove 5. The support cover 4 is more likely to form an arch in this area, avoiding compression of the space in the groove 5 and facilitating the entry of the guidewire and the external branch stent 300 into the groove 5. In particular, when the bending angle 4221 formed by the bending portion 422 is an obtuse angle, the relative space of movement between the first rod 4222 and the second rod 4223 increases, allowing for more flexible deformation. Furthermore, when the bending portion 422 bulges in a direction away from the groove 5, it can avoid forming a sharp structure that could damage the blood vessel wall.
[0124] In this embodiment, the bending angle 4221 of the bending portion 422 is located near the axial end of the support cover 4. For example, the bending angle 4221 is located between the axial end of the support cover 4 and the hook unit 47 closest to the axial end. When the inner branch support 6 is provided near the axial end of the support cover 4, the bending portion 422 can form an arched structure that bulges away from the groove 5 after the groove support 100 is implanted, providing a larger groove 5 space for the branch opening of the inner branch support 6 towards the groove 5, which facilitates the guide wire and the outer branch support 300 to enter the inner branch support 6.
[0125] Furthermore, the bending angle 4221 of the bent portion 422 bends toward the axial end of the support cover 4 that is close to it. This arrangement makes the mesh size of its attachment more uniform. In other embodiments, the bending angle 4221 of the bent portion 422 bends toward the axial end of the support cover 4 that is far away from it.
[0126] The first rod 4222 of the bent portion 422 extends from the bending angle 4221 toward one axial end of the support cover 4, and the second rod 4223 extends from the bending angle 4221 toward the other axial end of the support cover 4. Simultaneously, the first rod 4222 of the bent portion 422 extends toward one radial edge of the support cover 4, and the second rod 4223 extends toward the other radial edge of the support cover 4. The advantage of this arrangement is that both the first rod 4222 and the second rod 4223 extend at an angle relative to the axial and radial directions of the support cover 4, allowing the bent portion 422 to better adapt to the radial deformation of the support cover 4 and also better adapt to the axial bending deformation of the support cover 4.
[0127] The end of the first rod 4222 away from the bending angle 4221 of the bent portion 422 is connected to the edge of the groove 5. This arrangement allows the edge of the groove 5 to provide a certain support force for the first rod 4222. When the groove 5 is subjected to radial force, the end of the first rod 4222 away from the bending angle 4221 can better transmit the radial force, so that the first rod 4222 can more sensitively follow the deformation of the groove 5.
[0128] In this embodiment, refer to Figure 4 , Figure 8 , Figure 12 The edge wave angle 421 includes a vertex 4211 and two third wave rods 4212 connected to the vertex. The first rod 4222 serves as one of the third wave rods 4212 of the edge wave angle 421. The other third wave rod 4212 of the edge wave angle 421 extends from its vertex 4211 toward the axial end of the support cover 4 away from the vertex 4211 and is connected to the radial edge of the groove 5. The two third wave rods 4212 form an angle at the vertex 4211 of the edge wave angle 421. The included angle formed at the vertex 4211 of the edge wavy angle 421 should be appropriate. If the included angle is too large, it will cause uneven mesh size on both sides of the first rod 4222, and may also cause the first rod 4222 to extend approximately radially, making it difficult for the grooved support 100 to retract. If the included angle is too small, it will also cause uneven mesh size on both sides of the first rod 4222, and may make the vertex 4211 of the edge wavy angle 421 easily protrude and puncture blood vessels. Therefore, the included angle can be an acute angle, for example, within the range of 30° to 70°. Within this range, not only can the mesh size on both sides of the first rod 4222 be relatively uniform, but the vertex can also make the grooved support 100 easy to retract and provide good safety. The edge wavy angle 421 and the corner 53 of the groove 5 (refer to...) Figure 16 For example, the vertex 4211 of the edge wavy corner 421 is connected to the corner 53 of the groove 5, so it can support the corner 53 of the groove 5 to a certain extent, so that the corner 53 of the groove 5 can be fully unfolded and the shape of the opening of the groove 5 can be better maintained.
[0129] The second rod 4223 of the bent portion 422 passes through the second mesh area 42 and connects to the apex of the first hook 471 or the second hook 472 on the opposite side. For example, a part of the second rod 4223 serves as a support wire for the second mesh area 42, and a part serves as a wave rod for the hook unit. This arrangement allows the apex of the first hook 471 or the second hook 472 to provide a certain support force for the second rod 4223. When the groove 5 supports the cover 4 under radial force, the end of the second rod 4223 away from the bending angle 4221 can better transmit the radial force, allowing the second rod 4223 to more sensitively follow the deformation of the support cover 4. In addition, since the second rod 4223 passes through the second mesh area 42 to the opposite side, the first rod 4222 and the second rod 4223 can respectively transmit the compressive force on both radial sides of the support cover 4, thereby adapting to deformation and maintaining the space within the groove 5 well.
[0130] In this embodiment, the support cover 4 includes four side end connectors 42a and four bends 422. Two side end connectors 42a and two bends 422 are located at the near end of the support cover 4. The two side end connectors 42a are connected to two corners 53 of the near end of the groove 5, and the two bends 422 are connected to the two side end connectors 42a. Two side end connectors 42a and two bends 422 are located at the far end of the support cover 4. The two side end connectors 42a are connected to two corners 53 of the far end of the groove 5, and the two bends 422 are connected to the two side end connectors 42a. In other embodiments, the number of side end connectors 42a and bends can be selected according to the actual application scenario.
[0131] Reference Figure 5 In another embodiment, the support cover 4 further includes a side end connector 42a and a middle end connector 41a connected to the main support 10. The side end connector 42a is closer to the radial edge of the support cover 4 than the middle end connector 41a. Compared to a solution where the middle end connector 41a is not connected to the main support, since the middle end connector 41a is connected to the main support 10, it can better drive the support cover 4 to bend and deform in accordance with the shape of the blood vessel when the main support 10 bends. In addition, the middle end connector 41a connected to the main support 10 can also provide better support for the axial end of the groove 5, preventing the main support 10 and the middle end connector 41a from forming an axial gap when the groove support 10 bends. This prevents the narrow inner wall of the blood vessel from squeezing the gap and entering the internal space of the groove 5 from the gap, thereby blocking the guidewire and the outer branch stent 300 from entering the inner branch stent 6.
[0132] Furthermore, the intermediate end connector 41a located near the proximal end of the support cap 4 is closer to the proximal end of the grooved bracket 100 than the side end connector 42a located near the proximal end of the support cap 4, and / or, the intermediate end connector 41a located at the distal end of the support cap 4 is closer to the distal end of the grooved bracket 100 than the side end connector 42a located at the distal end of the support cap 4. Compared to the scheme where the axial ends of the side end connector 42a and the intermediate end connector 41a are flush, the scheme of this embodiment allows the support cap 4 at the location of the intermediate end connector 41a to have a larger axial dimension, so that the support cap 4 can form a better arched structure after bending with the main bracket 10, which can effectively prevent the axial end of the support cap 4 from forming an approximately flat surface when the main bracket 10 bends, better maintain the internal space of the groove 5, facilitate the entry of the guide wire and the external branch bracket 300 into the groove, and avoid excessive compression of the external branch bracket 300 after implantation.
[0133] For example, refer to Figure 5 , Figure 16 The intermediate end connector 41a includes an intermediate bevel 411, and the side end connector 42a includes an edge bevel 421. The vertex 4112 of the intermediate bevel 411 located near the support cover 4 is closer to the proximal end of the groove bracket 100 than the vertex 4211 of the edge bevel 421, and the vertex 4112 of the intermediate bevel 411 located at the distal end of the support cover 4 is closer to the distal end of the groove bracket 100 than the vertex 4211 of the edge bevel 421. This is in contrast to a scheme where the vertex 4112 of the intermediate bevel 411 is flush with the vertex 4211 of the edge bevel 421 (see reference...). Figure 4 After the support cover 4 is bent, the longer protrusion of the middle corrugation 411 reduces the axial stretch of the edge corrugations 421 on both sides. This better maintains the shape and size of the mesh in the area where the edge corrugations 421 are located, which is beneficial for the guide wire and the outer branch support 300 to pass through these meshes. Furthermore, the middle corrugation 411 provides sufficient stretch length to ensure that the proximal and distal ends of the support cover 4 are not stretched and deformed excessively toward the inner cavity of the groove 5. This effectively prevents the axial end of the support cover 4 from forming an approximately flat surface when the main support 10 is bent, instead forming a better arched structure, thereby effectively maintaining the internal space formed between the support cover 4 and the groove 5 at the proximal and distal ends.
[0134] In other embodiments, it may be similar Figure 4 The vertex 4112 of the intermediate wave angle 411 is flush with the vertex 4211 of the edge wave angle 421; or, the vertex 4211 of the edge wave angle 421 is made closer to the axial end of the corresponding groove support 100 than the vertex 4112 of the intermediate wave angle 411.
[0135] In one embodiment, specifically as follows Figure 5 , Figure 16 and Figure 17 As shown, the intermediate wave angle 411 includes two fourth wave rods 4113 connected to its vertex 4112. The vertex 4112 of the intermediate wave angle 411 is connected to one axial end of the groove 5, and the two fourth wave rods 4113 extend from the vertex 4112 of the intermediate wave angle 411 toward the other axial end of the groove 5. Further, the vertex 4112 of the intermediate wave angle 411 is axially opposite to the second mesh region 42, and the two fourth wave rods 4113 extend from the vertex 4112 of the intermediate wave angle 411 in a direction away from each other to connect with the first mesh regions 41 on both radially sides of the second mesh region 42, for example, to the hook units 47 on both radially sides of the support cover 4. When the main support 10 protrudes and bends towards the opening of the groove 5, the intermediate bevel 411 can cause the first mesh area 41 connected to it to bend, and at the same time cause the second mesh area 42 connected to the first mesh area 41 to bend. Since the first mesh area 41 includes multiple hook units 47, when the intermediate bevel 411 connects with the hook units 47, it can cause the mesh of the first mesh area 41 to expand fully when bending, thus making it easier for the guide wire and the outer branch support 300 to be inserted. At the same time, the hook units 47 can also limit the stretching length of the first mesh area 41 to a certain extent, thereby limiting the stretching length of the second mesh area 42 connected to it, avoiding problems such as the second mesh area 42 stretching too long and causing compression of the internal space of the groove 5 and the shrinkage of the mesh of the second mesh area 42. Therefore, it can better maintain the internal space of the groove 5 and the shape of the mesh of the second mesh area 42, further facilitating the insertion of the guide wire and the outer branch support 300.
[0136] Reference Figure 5 , Figure 16 and Figure 17Two fourth wave rods 4113 located at the near end of the support cover 4 extend from the apex 4112 of the middle wave angle 411 in a direction away from each other to form the first wave rods 4712 of the two hook units 47 on both sides of the radial side of the support cover 4. Two fourth wave rods 4113 located at the far end of the support cover 4 extend from the apex 4112 of the middle wave angle 411 in a direction away from each other to form the second wave rods 4722 of the two hook units 47 on both sides of the radial side of the support cover 4. The two fourth wave rods 4113 of the intermediate wave angle 411 can be approximately parallel to the first direction support wire 481 and the second direction support wire 482 of the second mesh region 42, respectively. In other embodiments, the two fourth wave rods 4113 of the intermediate wave angle 411 may not be parallel to the first direction support wire and the second direction support wire of the second mesh region 42. The angle of the intermediate wave angle 411 (that is, the included angle formed by the two fourth wave rods 4113 at the vertex 4112 of the intermediate wave angle 411) should be appropriate. When the angle of the intermediate wave angle 411 is too large and it is connected to the main cover membrane 31 by stitching, the intermediate wave angle 411 may easily slip relative to the main cover membrane 31 in the length direction of its fourth wave rods 4113. When the angle of the intermediate wave angle 411 is too small, the intermediate wave angle 411 is easy to puncture the main cover membrane 31 and damage the blood vessel wall. Therefore, the angle range of the intermediate wave angle 411 can be set to 20° to 80°, so as to stabilize and fix the intermediate wave angle 411 and avoid puncturing the main cover membrane 31 and damaging the blood vessel wall.
[0137] Furthermore, referring to Figure 5 , Figure 17 The two fourth wave rods 4113 of the intermediate wave angle 411 cross over the upper part of the bend 422. In this embodiment, the two fourth wave rods 4113 of the intermediate wave angle 411 cross over the upper part of the second rod 4223 of the two bends 422. In other embodiments, the two fourth wave rods 4113 of the intermediate wave angle can also cross over the upper part of the first rod 4222 of the two bends 422, as long as the two fourth wave rods 4113 of the intermediate wave angle 411 cross over the upper part of the bend 422. The advantage of this arrangement is that when the support cover 4 is radially compressed or bent, the bend 422 can bulge in a direction away from the groove 5, thereby supporting the fourth wave rods 4113 crossing over it. This avoids the intermediate wave angle 411 from being excessively stretched after the groove support 100 is bent, forming a relatively flat structure. Therefore, the support cover 4 can better maintain the internal space of the groove 5 at the axial end, avoiding encroachment on the space near the opening of the inner branch support 6.
[0138] When the grooved support 100 is in the unfolded state, the fourth wave rod 4113 of the intermediate wave angle 411 and the bending portion 422 can contact each other; or, there is a gap in the radial direction between the fourth wave rod 4113 of the intermediate wave angle 411 and the bending portion 422. Whether they are in contact or have a gap, the intermediate wave angle 411 can move relative to the bending portion 422, thus having better deformation capacity and conformity whether the support cover 4 is bent or straight, and can better maintain the internal space formed between the support cover 4 and the groove 5. When there is a gap in the radial direction between the fourth wave rod 4113 of the intermediate wave angle 411 and the bending portion 422, the gap allows the bending portion 422 to have more room to move, which is beneficial for the support cover 4 to better form an arched structure when bending away from the groove 5, and is more conducive to the guide wire and the outer branch support 300 entering the inner branch support 6.
[0139] In one embodiment, the fourth wave rod 4113 of the intermediate wave angle 411 can be an arc-shaped rod 4111, and the arc-shaped rod 4111 is an upwardly convex arched curved structure. Specifically, the upward convexity here refers to the convexity along the radial direction of the groove support 100 in a direction away from the central axis of the groove support 100. The convex arched curved structure can better facilitate the formation of a gap between the intermediate wave angle 411 and the bending portion 422. Furthermore, after the support cover 4 bends axially with the bending of the main support 10, the axial end of the support cover 4 can follow the arc-shaped rod 4111 to form an arched structure, providing stronger support performance. This can better maintain the internal space of the groove 5 at the axial end position and avoid excessive compression of the internal space.
[0140] Please see Figure 16 and Figure 17The inner branch support 6 of the main support 10 located in the proximal segment 2 is a double-branch support 61. The double-branch support 61 consists of two single-branch supports 62 connected side by side to the inner wall of the proximal segment 2 of the groove support 100 by stitching or bonding. The two single-branch supports 62 are usually set as approximately circular branch openings, and a gap 612 is formed between the two branch openings. Thus, when the double-branch support 61 is stitched to the proximal main body film of the groove support 100 at the proximal edge of the groove 5, the gap 612 will form a blank segment of the proximal main body film, which is used to support the cover 4 to be installed into the groove 5. At this time, the middle end connector 41a of the support cover 4 is connected to the proximal body film at the gap position 612. For example, the vertex 4112 of the middle wave angle 411 extends to the gap position 612, so that the vertex 4112 of the middle wave angle 411 is closer to the proximal end of the groove support 100 than the proximal edge of the groove 5, and the middle wave angle 411 is connected to the proximal body film at the gap position 612. The advantage of this arrangement is that the branch port 611 of the double branch port support 61 can provide a certain support for the middle wave angle 411, and can prevent the middle wave angle 411 from piercing the body film 31.
[0141] Understandably, the aforementioned intermediate end connector 41a can be connected to the main body film 31 (see reference). Figure 2 The inner or outer wall of the main body film 31, for example, the apex 4112 of the intermediate wave angle 411 and part of the fourth wave rod 4113 extend to the inner wall of the main body film 31 at the gap position 612, that is, the main body film 31 at the gap position 612 covers the outer side of the apex 4112 of the intermediate wave angle 411 and part of the fourth wave rod 4113, and the apex 4112 of the intermediate wave angle 411 and part of the fourth wave rod 4113 are connected to the inner wall of the main body film 31 by stitching; or, the main body film 31 at the gap position 612 covers the inner side of the apex 4112 of the intermediate wave angle 411 and part of the fourth wave rod 4113, and the apex 4112 of the intermediate wave angle 411 and part of the fourth wave rod 4113 are connected to the outer wall of the main body film 31 by stitching. When the intermediate end connector 41a is connected to the inner wall of the main body covering 31, it can prevent the intermediate end connector 41a from tilting outward and damaging the inner wall of the blood vessel when the grooved stent 100 deforms, which is beneficial to improving safety performance.
[0142] In other embodiments, the inner branch support 6 of the proximal segment 2 of the main support 10 may not be a double-branch support 61, while the inner branch support 6 of the distal segment 2 may be a double-branch support 61. In this way, the intermediate wave angle 411 located at the distal end of the support cover 4 can be connected to the main support 10 in accordance with the above-described connection method. In other embodiments, the connection position and connection method between the intermediate wave angle 411 and the main support 10 are not limited to this; a suitable connection position and connection method can be selected according to actual needs.
[0143] Furthermore, the branch openings 611 of the dual-branch bracket 61 are also provided with support members at their edges to better maintain the shape of the branch openings 611. At least a portion of these support members are connected to the main body film 31 and located on both sides of the intermediate end connector 41a to better support the intermediate wave angle 411.
[0144] Example 2
[0145] The grooved bracket 100 in this embodiment is largely the same as that in Embodiment 1. The similarities will not be repeated. The difference lies in the structure of the protection unit 72 of the grooved bracket 100 in this embodiment.
[0146] Reference Figure 18 , Figure 19 In this embodiment, at least one of the first protection unit 721 and the second protection unit 722 includes a main body piece 723 and an extension piece 724. Both the main body piece 723 and the extension piece 724 are sheet-like structures. One end of the main body piece 723 is connected to the hook unit 47, and the other end extends into the hook gap G and is connected to the extension piece 724. The extension piece 724 has a free end 7241, which extends towards the bottom of the groove 51, and the free end 7241 of the extension piece 724 is located between the support cover 4 and the bottom of the groove 51. The extension piece 724 helps to increase the contact area between the protection unit 72 and the inserted outer branch bracket 300, thereby better protecting the outer branch bracket 300. Furthermore, the radial gap between the extension piece 724 extending into the bottom 51 of the groove and the support cover 4 alters the hemodynamics of the blood in the groove 5, thereby accelerating the formation of a thrombus in a short time. This allows the thrombus to quickly fill the groove 5, thus sealing it. This provides support for the implanted external branch stent 300, preventing the external branch stent 300 from twisting and shifting. It also facilitates rapid endothelialization of the groove 5 and the support cover 4 area, further reducing the risk of damage to the external branch stent 300 caused by friction and cutting forces.
[0147] In this embodiment, the main body sheet 723 and the extension sheet 724 may be made of one or more polymeric materials selected from the following: PTFE, PET, ePTFE, FEP, silicone, polylactic acid (PLA), racemic PLA, polyglycolic acid, polylactic-co-glycolic acid copolymer, polyhydroxyalkanoate, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate, polyglycolic acid, and polydioxanone. Other suitable materials may also be used. The main body sheet 723 and the extension sheet 724 may be made of the same material or different materials.
[0148] Furthermore, the aforementioned extension piece 724 may have a certain guiding function, as it can bend towards the inner branch stent 6 to guide the guidewire into the inner branch stent 6 better, thereby improving the efficiency and success rate of the surgery. For example, the aforementioned extension piece 724 may be made of silicone material, which has a certain shape stability and can effectively guide the guidewire to move towards the inner branch stent 6. In another embodiment, both the first protection unit 721 and the second protection unit 722 include extension pieces 724, and the extension pieces 724 of the two are at least partially connected to each other to form a guide channel. This guide channel bends and extends towards the inner branch stent 6, thereby better guiding and promoting endothelialization.
[0149] Example 3
[0150] The grooved bracket 100 in this embodiment is largely the same as that in Embodiment 1. The similarities will not be repeated. The difference lies in the structure of the protection unit 72 of the grooved bracket 100 in this embodiment.
[0151] Reference Figure 20 At least one of the first protection unit 721 and the second protection unit 722 includes a sheet-like structure with a movable end. At least a portion of this movable end is movable relative to the hook unit 47. This movable end includes a thin-walled region, the thickness of which is less than the thickness of other regions of the protection unit 72. When the outer branch bracket 300 is inserted into the hook gap G from the outside towards the groove 5, at least a portion of the thin-walled region deforms relative to other regions and extends towards the bottom 51 of the groove, thus forming a structure similar to the extension piece 724 in Embodiment 2. This increases the contact area between the protection unit 72 and the inserted outer branch bracket 300, thereby better protecting the outer branch bracket 300. Furthermore, the thin-walled region extending into the groove bottom 51 between the support cap 4 alters the hemodynamics of the blood in the groove 5, thereby accelerating the formation of a thrombus in a short time. This allows the thrombus to quickly fill the groove 5, thus sealing it. This provides support for the implanted external branch stent 300, preventing the external branch stent 300 from twisting and shifting. It also facilitates rapid endothelialization of the groove 5 and support cap 4 areas, further reducing the risk of damage to the external branch stent 300 caused by friction and cutting forces.
[0152] In this embodiment, refer to Figure 21The first protective unit 721 includes a third sheet structure 7213, and the second protective unit 722 includes a fourth sheet structure 7223. The third sheet structure 7213 has a first movable end 7214, which includes a thin-walled region. The edge of the first movable end 7214 is the edge of the third sheet structure 7213 further away from the trough 4711, and the edge of the first movable end 7214 is generally arc-shaped, curving towards the crest 4721. The fourth sheet structure 7223 has a second movable end 7224, which also includes a thin-walled region. The edge of the second movable end 7224 is the edge of the fourth sheet structure 7223 further away from the crest 4721, and the edge of the second movable end 7224 is generally arc-shaped, curving towards the crest 4721. The shape of the edge of the second movable end 7224 matches the shape of the edge of the first movable end 7214 to completely cover the hook gap G. This arrangement facilitates the deformation of the thin-walled regions of the first movable end 7214 and the second movable end 7224 relative to other regions of the sheet structure and their extension toward the direction near the bottom 51 of the groove when the third sheet structure 7213 and the fourth sheet structure 7223 are inserted between them by the outer branch bracket 300. It is understood that in other embodiments, the shapes of the edges of the first movable end 7214 and the second movable end 7224 can be any other suitable shape, as long as they match and completely cover the hook gap G. For example, both can be straight, S-shaped, or polygonal. In other embodiments, the thin-walled regions of the first movable end 7214 and the second movable end 7224 may overlap radially in the groove 5 to completely cover the hook gap G. In this case, the shapes of the edges of the first movable end 7214 and the second movable end 7224 can be any suitable shape and do not necessarily match.
[0153] Furthermore, in other embodiments, the thin-walled region itself can be made closer to the bottom 51 of the groove relative to the hook unit 47, which can increase the probability of deformation of the thin-walled region relative to other regions of the sheet structure when the outer branch bracket 300 is inserted into the hook gap G. In addition, other regions of the sheet structure can also play a certain guiding role.
[0154] Furthermore, referring to Figure 20 The thin-walled region may include at least one easily crackable strip 725, which may be in any suitable shape, such as straight, curved, or zigzag. In this embodiment, the easily crackable strip 725 may be a region that is thinner than other regions of the thin-walled region. For example, an indentation obtained by hot pressing on the thin-walled region may have an area that is thinner than other regions of the thin-walled region. In other embodiments, multiple small holes may be spaced apart along the length of the easily crackable strip 725 to achieve the same easily crackable effect.
[0155] In this embodiment, the easily crackable strip 725 extends approximately along the axial direction of the grooved support 100, with one end extending to the edge of the movable end and the other end extending away from the movable end. In other embodiments, the easily crackable strip 725 may be inclined at a certain angle to the axial direction of the grooved support 100, which angle may be greater than 0° and less than 90°. In other embodiments, the easily crackable strip 725 may not extend to the edge of the movable end, and it may be at 90° to the axial direction of the grooved support 100. When the easily crackable strip 725 forms a crack, the sheet-like structure is at least divided into two pieces in the axial direction, of which the piece closer to the edge of the movable end is more easily deformed towards the bottom 51 of the groove by the inserted outer branch support 300.
[0156] In this embodiment, the easily crackable strip 725 cracks when the outer branch bracket 300 is inserted into the hook gap G from the outside towards the bottom 51 of the groove, forming a crack. At least a portion of the thin-walled region adjacent to the crack deforms relative to other regions of the sheet structure and extends towards the bottom 51 of the groove. This arrangement helps to further increase the probability of deformation of the thin-walled region relative to other regions of the sheet structure when the outer branch bracket 300 is inserted into the hook gap G, and the easily crackable strip can better guide the thin-walled region to form the desired shape after the outer branch bracket 300 is inserted.
[0157] The aforementioned protective unit 72 may be made of one or more of the following polymer materials: PTFE, PET, ePTFE, FEP, silicone, L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic-co-hydroxyacetic acid copolymer, polyhydroxy fatty acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate ester, polyglycolic acid, and polydioxanone, or any other suitable material.
[0158] Example 4
[0159] The grooved bracket 100 in this embodiment is largely the same as that in Embodiment 1. The similarities will not be repeated. The difference lies in the structure of the protection unit 72 of the grooved bracket 100 in this embodiment.
[0160] Reference Figure 21 The protective structure 70 in this embodiment includes a third protective unit 726, which includes a polymer coating 7261 covering the hook gap G. The troughs 4711 of the first hook unit 471 and / or the peaks 4721 of the second hook unit 472 are axially movable relative to each other. At least a portion of the support cover 4 has insertion holes; for example, insertion holes are formed between two adjacent hook units 47 for the guide wire and the outer branch support 300 to be inserted. This arrangement helps reduce the probability that the outer branch support 300 is guided into the hook gap G by the guide wire, thereby reducing the probability of the outer branch support 300 being damaged by friction.
[0161] The third protective unit 726 includes a double-layer polymer coating, namely a first coating and a second coating. The first coating covers the hook gap G on the outer side of the hook unit 47 (i.e., the side further away from the bottom 51 of the groove), and the second coating covers the hook gap G on the inner side of the hook unit 47 (i.e., the side closer to the bottom 51 of the groove). The first and second coatings overlap to sandwich the hook unit 47 between them. A receiving gap is also formed between the first and second coatings. The trough 4711 of the first hook unit 471 and / or the peak 4721 of the second hook unit 472 are located in the receiving gap, so that the trough 4711 of the first hook unit 471 and / or the peak 4721 of the second hook unit 472 can move relative to each other in the axial direction, so that the support cover 4 still has good bending performance and can conform well to the shape of the blood vessel wall.
[0162] In other embodiments, the trough 4711 of the first hook unit 471 and / or the peak 4721 of the second hook unit 472 may be located on one side of the double-layer polymer coating. For example, the first coating is provided with a first perforation and a second perforation. The trough 4711 of the first hook unit 471 and the part of the wave rod section connected to the trough 4711 pass through the first perforation and are located on the outside of the first coating. The peak 4721 of the second hook unit 472 and the part of the wave rod section connected to the peak 4721 pass through the second perforation and are also located on the outside of the first coating. In other embodiments, the second film may have a first perforation and a second perforation. The trough 4711 of the first hook unit 471 and the part of the wave rod section connected to the trough 4711 pass through the first perforation and are located inside the second film. The peak 4721 of the second hook unit 472 and the part of the wave rod section connected to the peak 4721 pass through the second perforation and are also located inside the second film. In other embodiments, the trough 4711 of the first hook unit 471 and the portion of the wave rod connected to the trough 4711 may be located outside the first coating, and the peak 4721 of the second hook unit 472 and the portion of the wave rod connected to the peak 4721 may be located inside the second coating; or, the trough 4711 of the first hook unit 471 and the portion of the wave rod connected to the trough 4711 may be located inside the second coating, and the peak 4721 of the second hook unit 472 and the portion of the wave rod connected to the peak 4721 may be located outside the first coating. This is acceptable as long as the polymer coating 7261 completely covers the hook gap G, and the trough 4711 of the first hook unit 471 and / or the peak 4721 of the second hook unit 472 are relatively movable in the axial direction.
[0163] Reference Figure 22The polymer coating 7261 can further cover the other braided filaments 40 on the support cover 4 to provide better protection for the support cover 4 and the outer branch bracket 300. However, at least a portion of the support cover 4 must have insertion holes 7262 so that the guide wires and the outer branch bracket 300 can be inserted through the insertion holes 7262 into the radial gap between the support cover 4 and the bottom of the groove 51. The shape of the insertion holes 7262 is not limited, and can be, for example, a circle, an ellipse, a triangle, a quadrilateral, or other polygons or any other suitable shape.
[0164] Furthermore, one or more crackable strips 725 may be provided on the edge of the aforementioned insertion hole 7262. The shape and position of the crackable strips 725 can be referred to the description in Embodiment 3, and will not be repeated here. When subjected to external force, the crackable strips 725 easily crack to increase the perimeter of the insertion hole 7262, which can not only accommodate the insertion of various sizes of external branch brackets 300, but also, after the external branch bracket 300 is inserted, the area of the polymer coating 7261 adjacent to the crack formed by the crackable strip 725 deforms relative to other areas of the polymer coating 7261 and extends towards the direction near the bottom 51 of the groove. This is beneficial to increase the contact area between the protection unit 72 and the inserted external branch bracket 300, thereby better protecting the external branch bracket 300. Furthermore, the polymer membrane 7261 extending into the area between the bottom 51 of the groove and the support cover 4 alters the hemodynamics of the blood in the groove 5, thereby accelerating the formation of a thrombus in a short time. This allows the thrombus to quickly fill the groove 5, thus sealing it. This provides support for the implanted external branch stent 300, preventing the external branch stent 300 from twisting and shifting. It also facilitates rapid endothelialization of the groove 5 and the support cover 4 area, further reducing the risk of damage to the external branch stent 300 caused by friction and cutting forces.
[0165] The aforementioned protective unit 72 may be made of one or more of the following polymer materials: PTFE, PET, ePTFE, FEP, silicone, L-polylactic acid, racemic polylactic acid, polyglycolic acid, polylactic-co-hydroxyacetic acid copolymer, polyhydroxy fatty acid ester, polydioxanone, polycaprolactone, polygluconic acid, polyhydroxybutyric acid, polyanhydride, polyphosphate ester, polyglycolic acid, and polydioxanone, or any other suitable material.
[0166] Example 5
[0167] This embodiment provides a grooved bracket 100, which includes a main bracket 10 and a support cover 4. The main bracket 10 is tubular and has an inner cavity. The side of the main bracket 10 is recessed towards its inner cavity to form a groove 5, and the groove 5 includes a groove bottom 51. The support cover 4 is connected to the main bracket 10, and at least a portion of the support cover 4 and the groove bottom 51 form a radial gap in the radial direction of the grooved bracket 100. The support cover 4 includes a mesh structure 4a woven from braided yarns 40. The mesh structure 4a includes a plurality of mesh holes, which communicate the groove 5 with the outside. The grooved bracket 100 of this embodiment can adopt any of the bracket structures in Embodiments 1 to 4. The specific bracket structure can be referred to the description in Embodiments 1 to 4, which will not be repeated in this embodiment. It can be understood that this embodiment can also adopt any other suitable bracket structure. For example, the braiding structure of the support cover 4 of the grooved bracket 100 can be different from that in the previous embodiments, and the protective structure 70 may not be provided on the support cover 4. In the foregoing embodiment, the support cover 4 of the groove bracket 100 includes a mesh structure 4a woven from braided yarns 40. The mesh structure 4a includes a braiding start end B0 and a braiding end E0. The braiding start end B0 and the braiding end E0 can be connected to each other by welding, bonding, winding, etc., and can be a fixed connection or a movable connection.
[0168] Reference Figure 23 , Figure 24 In this embodiment, the starting end B0 and the ending end E0 of the knitting are fixed to each other by the fastener 8. The fastener 8 not only securely connects the starting end B0 and the ending end E0 of the knitting, but also avoids the risk of damage to the mechanical properties of the area near the starting end B0 and the ending end E0 of the knitting caused by welding.
[0169] Exemplarily, the fastener 8 includes a fixing sleeve 81, which has an inner cavity in which the braiding start end B0 and the braiding end E0 are fixed. The braiding start end B0 and the braiding end E0 can be fixed to the fixing sleeve 81 by applying pressure outside the fixing sleeve 81. The braiding start end B0 and the braiding end E0 are arranged opposite each other along the length of the braiding yarn 40; for example, they are joined together as shown in the figure. In other embodiments, the braiding start end B0 and the braiding end E0 may be spaced apart. The advantage of having the braiding start end B0 and braiding end E0 arranged opposite each other along the length direction in the fixing sleeve 81 is that it reduces the width at the connection between the braiding start end B0 and the braiding end E0, allowing for a narrower fixing sleeve 81. This reduces the risk of the fixing sleeve 81 snagging on braided yarns 40 in other areas, preventing the mesh near the fixing member 8 from fully unfolding and thus hindering the insertion of the guide wire or outer branch support 300. Furthermore, it also reduces the risk of damage to the braided yarns 40 caused by friction or snagging on braided yarns 40 in other areas. Understandably, in other embodiments, the braiding start end B0 and braiding end E0 may also be arranged side-by-side in the width direction in the fixing sleeve 81. Understandably, the structure of the fixing member 8 in this embodiment is not unique. Besides the fixing sleeve 81 exemplified in this embodiment, it can also be a fixing wire or a fixing ring, such as using a fixing wire to wrap or sew the braiding start end B0 and braiding end E0, or wrapping and fixing the braiding start end B0 and braiding end E0 to a fixing ring.
[0170] The fixation element 8 can be made of a material with certain imaging properties, and can assist in positioning under imaging equipment such as digital subtraction angiography (DSA). For example, the fixation element 8 can be made of metal materials such as stainless steel, nickel-titanium, or platinum, or it can be made of polymer materials doped with imaging materials such as iohexol, or any other suitable material. When the fixation element 8 includes a fixation sleeve 81, since the fixation sleeve 81 is fitted over the braiding start end B0 and the braiding end E0, and its width is greater than the diameter of the braided filament 40, the position of the fixation element 8 can be well distinguished under imaging images, which is beneficial to improving the effect of auxiliary positioning.
[0171] In this embodiment, there may be multiple fixation members 8, with at least one fixation member 8 having an axial distance from the proximal end of the groove opening 52 that is less than the axial distance from the distal end of the groove opening 52; or, at least one fixation member 8 having an axial distance from the proximal end of the groove opening 52 that is greater than the axial distance from the distal end of the groove opening 52. This arrangement is intended to guide the surgeon in aligning the branch vessel 200, resulting in more accurate insertion of the subsequent external branch stent 300. Furthermore, this arrangement reduces the risk of damage to the fixation members 8 and the adjacent braided wires 40 caused by the groove stent 100 bulging and bending towards the support cap 4 in accordance with the vessel after implantation.
[0172] For example, when the axial distance between the fixation member 8 and the proximal end of the groove opening 52 is less than the axial distance between the fixation member 8 and the distal end of the groove opening 52, the ratio of the axial distance between the fixation member 8 and the proximal end of the groove opening 52 to the axial length of the groove opening 52 ranges from 5% to 15%; when the axial distance between the fixation member 8 and the proximal end of the groove opening 52 is greater than the axial distance between the fixation member 8 and the distal end of the groove opening 52, the ratio of the axial distance between the fixation member 8 and the distal end of the groove opening 52 to the axial length of the groove opening 52 ranges from 5% to 15%. Due to continuous vascular pulsation, the implanted groove stent 100 may experience slight displacement, which may cause a difference between the position indicated by the fixation member 8 and the desired position. By limiting the axial distance between the fixation member 8 and the axial end of the groove opening 52 to greater than or equal to 5% of the axial length of the groove opening 52, positional errors caused by vascular pulsation can be accommodated for displacement of the groove stent 100. Furthermore, by limiting the axial distance of the fastener 8 from the axial end of the groove opening 52 to less than or equal to 15% of the axial length of the groove opening 52, the probability of the anchoring area between the outer branch bracket 300 and the inner branch bracket 5 located near the groove opening 52 being too short due to the distance being too far from the groove opening 52 can be reduced.
[0173] Reference Figure 23 In this embodiment, the fixing member 8 is located at the edge of the support cover 4. For example, the fixing member 8 may be provided at the radial edge and / or axial edge of the support cover 4. Since the fixing member 8 is located at the edge of the support cover 4, the braided yarns 40 located at the edge are less likely to slide relative to the braided yarns 40 in other areas compared to other areas of the support cover 4. Therefore, the risk of damage to the braided yarns 40 caused by friction between the fixing member 8 and other braided yarns 40 can be reduced. At the same time, the risk of the fixing member 8 hooking onto other braided yarns 40 and causing mesh deformation and failure to fully unfold can be reduced. In particular, when the fixing member 8 is provided at the radial edge of the support cover 4, even if the grooved bracket 100 is subjected to a large radial compressive force (for example, the grooved bracket 100 is loaded in the conveyor), the fixing member 8 is not easily broken and can always maintain a stable connection.
[0174] Reference Figure 23 , Figures 27-29 The groove 5 includes an axial edge and a radial edge. The axial edges of the groove 5 are spaced apart and opposite to each other along the axial direction of the groove support 100, and the radial edges of the groove 5 are spaced apart and opposite to each other along the radial direction of the groove support 100. A corner 53 is formed between the axial edge and the radial edge of the groove 5. The fastener 8 includes a first axial end 82 and a second axial end 83. The first axial end 82 of the fastener 8 is located at or near the corner 53 of the groove 5 (wherein, the first axial end 82 of the fastener 8 being located near the corner 53 of the groove 5 means that the distance between the first axial end 82 of the fastener 8 and the corner 53 of the groove 5 does not exceed 5mm). The second axial end 83 of the fastener 8 is further away from the corner than the first axial end 82, and the fastener 8 is arranged along the radial edge of the groove 5. It should be noted that the fastener 8 being arranged along the radial edge of the groove 5 does not mean that the fastener 8 must be arranged as shown in the image. Figure 27 As shown, the radial edge of the groove 5 is completely fitted, allowing for a gap between a portion of the fastener 8 and the radial edge of the groove 5. In other embodiments, the fastener 8 may be disposed along the axial edge of the groove 5. Compared to being disposed along the axial edge of the groove 5, the fastener 8 in this embodiment, being disposed along the radial edge of the groove 5, is less likely to break when the groove support 100 is subjected to a large radial compressive force, thus maintaining a stable connection. Furthermore, it reduces the probability of the fastener 8's end being damaged (e.g., punctured) on the radial sidewall of the groove 5 when subjected to radial compression. In other embodiments, the fixing member 8 may be disposed at a position away from the corner 53 on the radial edge of the groove 5. Compared with the fixing member 8 being disposed away from the corner 53, the fixing member 8 in this embodiment is disposed close to the corner 53 of the groove 5, which can avoid affecting the lateral bending performance of the groove 5 area and can also help the surgeon to better determine the release position of the groove stent 100. For example, with the assistance of imaging equipment, the position of the axial edge of the groove 5 can be indicated to the surgeon by identifying the imaging of the fixing member 8, which can avoid the obstruction of blood flow in the branch vessel 200 due to inaccurate release position of the groove stent 100.
[0175] Reference Figure 23 The support cover 4 is connected to the groove 5 via an edge bevel 421, and the fixing member 8 is provided on the edge bevel 421, which is connected to the hook unit 47. (Refer to...) Figure 23The fixing member 8 is located on the third wave rod 4212 (denoted as edge wave rod 4212a), which is directly connected to the radial edge of the groove 5. The edge wave rod 4212a extends approximately along the radial edge of the groove 5 and is connected to the hook unit 47. For example, the edge wave rod 4212a is connected to the second hook 472 of the hook unit 47. Since the first hook 471 and the second hook 472 of the hook unit 47 can move relative to each other in the axial direction, the axial force or axial movement in other areas of the support cover 4 is not easily transmitted to the edge wave rod 421, which reduces the risk of the apex 4211 of the edge wave rod 421 piercing and injuring blood vessels.
[0176] Furthermore, the fastener 8 can be adjacent to or near the vertex 4211 of the edge wavy angle 421 (the fastener 8 being near the vertex 4211 of the edge wavy angle 421 means that the distance between the fastener 8 and the vertex 4211 of the edge wavy angle 421 of the groove 5 is no more than 5mm). Since the width of the fastener 8 is larger than that of the braided wire 40, it can play a certain limiting role in the vertex 4211 of the edge wavy angle 421, which can further reduce the risk of the vertex 4211 of the edge wavy angle 421 piercing and injuring blood vessels.
[0177] In this embodiment, the support cover 4 includes a first proximal edge bevel 421c, a second proximal edge bevel 421d, a first distal edge bevel 421a, and a second distal edge bevel 421b. The fixing member 8 is located at the first distal edge bevel 421a. Since a double-branch bracket 61 is provided near the proximal end of the support cover 4 (i.e., near the proximal end of the groove opening 52), while a single-branch bracket 62 is provided near the proximal end of the support cover 4 (i.e., near the distal end of the groove opening 52), placing the fixing member 8 at the distal end of the support cover 4 (i.e., at the distal end of the groove opening 52) helps to avoid increasing the difficulty of retracting the sheath near the proximal end of the support cover 4. Furthermore, after implantation, the grooved stent 100 will bend laterally to conform to the blood vessel. The radial edge where the first distal edge wavy angle 421a is located is on the outer side of the lateral bend (i.e. the side that is stretched when bending), and the radial edge where the second distal edge wavy angle 421b is located is on the inner side of the lateral bend (i.e. the side that is compressed when bending). Therefore, the fixing member 8 located at the first distal edge wavy angle 421a will not hinder the lateral bending of the support cover 4, thus ensuring good lateral bending performance of the support cover 4. Furthermore, as shown in the figure, since a fixing member 8 is provided at the first distal edge 421a, the first side connection point 46a connected to the first distal edge 421a can be omitted compared to the second distal edge 421b located on the radial opposite side of the first distal edge 421a. This makes the mesh area of the mesh where the first distal edge 421a is located larger than the mesh area of the mesh where the second distal edge 421b is located, which facilitates the insertion of the guide wire and the outer branch support 300.
[0178] Reference Figures 27-29 The radial edge of the groove 5 has an inner wall 501, and the fastener 8 is fixedly connected to the inner wall 501. The fixed connection method includes suturing, bonding, etc. The advantage of this arrangement is that even if the fastener 8 or the braided filament 40 in the adjacent area of the fastener 8 breaks, the sidewall of the radial edge of the groove 5 (which is covered with a membrane) can prevent the broken fastener 8 or the braided filament 40 near the broken fastener 8 from piercing out and damaging the tissue wall.
[0179] In this embodiment, the fastener 8 is sewn to the inner wall 501 of the radial edge of the groove 5 by a suture. The suture forms multiple sewing points 9 on the outer surface of the fastener 8. For example, the suture is wound around the outer surface of the fastener 8 to form multiple loops, which are arranged along the length of the fastener 8. Each loop fixes the fastener 8 to the inner wall 501 of the radial edge of the groove 5, forming a sewing point 9. By forming multiple sewing points 9 on the outer surface of the fastener 8, a stable connection between the fastener 8 and the radial edge of the groove 5 can be ensured. It is understood that in other embodiments, the number of sewing points 9 may be one or more, and the stitching method may differ from that exemplified in this embodiment.
[0180] Furthermore, referring to Figure 24 and Figure 29 In this embodiment, the braided yarn segment adjacent to the braiding start end B0 is designated as the first segment 401, and the braided yarn segment adjacent to the braiding end E0 is designated as the second segment 402. The first segment 401 includes a first inner segment 4011 located within the fixing sleeve 81 and a first outer segment 4012 connected to the first inner segment 4011 and located outside the fixing sleeve 81. The second segment 402 includes a second inner segment 4021 located within the fixing sleeve 81 and a second outer segment 4022 connected to the second inner segment 4021 and located outside the fixing sleeve 81. The first outer segment 4012 and / or the second outer segment 4022 are fixedly connected to the inner wall 501 of the radial edge of the groove 5. Even if the braided yarn segment near the end of the fixing sleeve 81 breaks, it can prevent the broken braided yarn 40 from piercing out and damaging the inner wall of the tissue.
[0181] Reference Figure 25 , Figure 26In another embodiment, the fixing member 8 may be disposed in the second mesh region 42, the specific structure of which can be referred to the description of Embodiment 1. The fixing member 8 is disposed on the first direction support wire 481 or the second direction support wire 482. Whether in the loaded or implanted state of the grooved bracket 100, the fixing member 8 and its adjacent braided wire segments located on the first direction support wire 481 or the second direction support wire 482 will not be subjected to excessive bending forces. Therefore, the fixing member 8 and its adjacent braided wire segments are less likely to break, causing damage to the support cover 4 or puncturing damaged tissue. For example, the fixing member 8 is located at the nearest cross unit 48a in the second mesh region 42 (refer to...). Figure 25 ) or located at the farthest intersection unit 48b (refer to Figure 26 In other embodiments, the fixator 8 is located near the nearest intersection unit 48a in the second mesh region 42 (the distance from the nearest intersection unit 48a does not exceed 5mm) or near the farthest intersection unit 48 (the distance from the farthest intersection unit 48b does not exceed 5mm). This location allows for good indication of the insertion position of the outer branch support 300. Furthermore, it not only allows for positional errors in the displacement of the groove support 100 but also reduces the probability that the anchorage area between the outer branch support 300 and the inner branch support 5 located near the groove opening 52 is too short due to excessive distance from the groove opening 52. Further, when the fixator 8 is located at the intersection unit 48 in the second mesh region 42, it is positioned on the support wire closer to the bottom 51 of the groove within that intersection unit 48. This arrangement reduces the impact of another support wire between the fixator 8 and the tissue wall after implantation, allowing the fixator 8 some room to move and reducing stimulation of the tissue wall by the fixator 8.
[0182] In this embodiment, at least part of the outer surface of the fastener 8 can be provided with a protective structure 70. In particular, when the protective structure 70 includes a polymer film layer and completely covers the outer surface of the fastener 8, the fastener 8 and its adjacent braided filament sections are not easily broken, which would cause damage to the support cover 4 or puncture of damaged tissue. Even if it is broken, it is not easy to directly puncture the damaged tissue.
[0183] Reference Figure 2 , Figure 23 and Figure 30 This embodiment also provides a method for preparing the grooved support 100, including:
[0184] S10: Provides main support bracket 10 and support cover 4;
[0185] S20: Connect the support cover 4 to the main support bracket 10.
[0186] The method for preparing the aforementioned support cover 4 includes:
[0187] S11: Provides 40% braiding yarn;
[0188] S12: The braided yarn 40 is braided through multiple paths to form a mesh structure 4a, the mesh structure 4a including the braiding start end B0 and the braiding end;
[0189] S12: The starting end B0 and the ending end E0 of the mesh structure 4a are fixed together by fastener 8.
[0190] The aforementioned mesh structure 4a can be integrally woven from braided yarns 40, with only one starting end B0 and one ending end E0. For example, in this embodiment, the mesh structure 4a is integrally woven from a single braided yarn 40, and this braided yarn 40 is a monofilament. In other embodiments, the mesh structure 4a can be woven from multiple braided yarns 40, each of which can be a monofilament structure or a structure formed by multiple yarns intertwined. In other embodiments, the support cover 4 may also include multiple mesh structures 4a, each of which can be integrally woven or woven separately and then spliced together.
[0191] The aforementioned multiple paths include multiple first-direction paths and multiple second-direction paths. The following is an example of step S12, illustrated in the figure.
[0192] Step S12 includes:
[0193] Step A: Weave along the first direction path to form a first direction weave unit;
[0194] Step B: Weave along the second direction path to form a second direction weave unit;
[0195] Repeat steps A and B alternately until a network structure 4a is formed.
[0196] Reference Figure 30 The first directional path refers to the path extending from right to left as shown in the diagram, such as P1, P3, P5, P7, and P9. The second directional path refers to... Figure 30 Paths extending from left to right, such as P2, P4, P6, P8, and P10, are all second-direction paths. Each first-direction path and each second-direction path can include multiple sub-paths. Figure 30In the diagram, P11 to P104 represent multiple sub-paths. For example, P1 includes sub-paths P11, P12, P13, and P14; P2 includes sub-paths P21, P22, and P23; P3 includes sub-paths P31, P32, and P33; P4 includes sub-paths P41, P42, and P43; P5 includes sub-paths P51, P52, and P53; P6 includes sub-paths P61, P62, P63, and P64; P7 includes sub-paths P71, P72, and P73; P8 includes sub-paths P81, P82, and P83; P9 includes sub-paths P91, P92, and P93; and P10 includes sub-paths P101, P102, P103, and P104.
[0197] For example, starting from the knitting start point B0, knitting proceeds sequentially along sub-paths P11, P12, P13, and P14 of path P1 to form a first-direction knitting unit A1; sequentially along sub-paths P21, P22, and P23 of path P2 to form a second-direction knitting unit B1; sequentially along sub-paths P31, P32, and P33 of path P3 to form a first-direction knitting unit A2; sequentially along sub-paths P41, P42, and P43 of path P4 to form a second-direction knitting unit B2; sequentially along sub-paths P51, P52, and P53 of path P5 to form a first-direction knitting unit A3; and sequentially along sub-paths P61, P62, and P63 of path P6... P63 and P64 are woven together to form a second-direction knitting unit B3. Then, along sub-paths P71, P72, and P73 of path P7, a first-direction knitting unit A4 is formed. Next, along sub-paths P81, P82, and P83 of path P8, a second-direction knitting unit B4 is formed. Then, along sub-paths P91, P92, and P93 of path P9, a first-direction knitting unit A5 is formed. Finally, along sub-paths P101, P102, P103, and P104 of path P10, a second-direction knitting unit B5 is formed. Knitting ends at knitting terminal E0. Finally, the knitting start end B0 and knitting terminal E0 are cut to a suitable length and secured together with fastener 8.
[0198] In this configuration, the first direction knitting unit and the second direction knitting unit are alternately formed and interconnected, and at least one intersection point is formed between adjacent first direction knitting units and second direction knitting units.
[0199] Understandably, in other embodiments, the first directional path can be from left to right, and the second directional path can be from right to left. In other embodiments, the knitting start end and the knitting end end can be completely different from this embodiment. For example, E0 can be used as the knitting start end, and B0 as the knitting end end, according to... Figure 30Weaving in the opposite direction of the middle arrow can also create a mesh structure 4a; for example, the weaving start and end points can be selected near the intersection of sub-path P22 and sub-path P102, or any other suitable weaving start and end points, as long as weaving can achieve the formation of mesh structure 4a.
[0200] Side connectors 46 may also be provided between adjacent first-direction knitting units and second-direction knitting units. For example, a second side connector 46b is provided between a first-direction knitting unit A1 and a second-direction knitting unit B1 located at the axial end; a second side connector 46b is provided between a first-direction knitting unit A3 and a second-direction knitting unit B3 located at the other axial end; a second side connector 46b is provided between a first-direction knitting unit A4 and a second-direction knitting unit B3; and a first side connector 46a is provided between adjacent first-direction knitting units and second-direction knitting units, except at the knitting start end B0 and the knitting end. In this embodiment, the shape of the first side connector 46a is different from the shape of the second side connector 46b. (Refer to...) Figure 30 The first side connector 46a is roughly triangular, while the second side connector 46b is roughly elliptical. In other embodiments, both can adopt any other suitable shape, as described in Embodiment 1. In other embodiments, both can have the same shape.
[0201] Understandably, the structure of the grooved support 100 in Embodiments 1 to 5 above may differ from the structure exemplified above. Please refer to... Figure 31In some embodiments, the grooved stent 100 includes a first branch stent 601 and a second branch stent 602. The first branch stent 601 is disposed within the main stent 10 and communicates with the groove 5. One end of the second branch stent 602 is fixedly connected to and communicates with the main stent 10, while the other end is a free end with a branch opening. The free end of the second branch stent 602 is located outside the main stent 10 and is used for implantation into the branch blood vessel 200 or connection with other stents. The length extension direction of the second branch stent 602 intersects the axial direction of the grooved stent 100; both the second branch stent 602 and the first branch stent 601 communicate with the inner lumen of the main stent 10. After the second branch stent 602 connects with the corresponding branch vessel 200, the groove 5 of the grooved stent 100 aligns with the opening of the other branch vessels 200. This reduces the likelihood of the groove 5 being difficult to align with the corresponding branch vessel 200 due to deflection after the grooved stent 100 is released. Furthermore, the free end of the second branch stent 602 is located outside the main stent 10, allowing the second branch stent 602 to be implanted into the branch vessel 200 without occupying space within the main stent 10's cavity. This reduces the space occupied by the branch stent within the main stent 10's cavity and increases blood flow within the main stent 10's cavity. Compared to the first branch stent 601 and the second branch stent 602 being arranged radially side-by-side within the main stent 10, this embodiment, by placing the free end of the second branch stent 602 outside the main stent 10, allows the guidewire or external branch stent 300 to more accurately enter the corresponding branch stent, reducing the risk of the guidewire accidentally entering another branch stent. For example, the length extension direction of the second branch stent 602 is perpendicular to the axial direction.
[0202] Please see Figure 31 and Figure 32In some embodiments, a first branch stent 601 is disposed within the main body stent 10 and communicates with the groove 5; a second branch stent 602 and the first branch stent 601 are disposed on one side of the axial direction of the groove 5. For example, the second branch stent 602 and the first branch stent 601 are disposed on the proximal end side of the groove 5, that is, both the second branch stent 602 and the first branch stent 601 are disposed on the proximal segment 2 of the main body stent 10. If the first branch stent 601 and the second branch stent 602 are arranged radially side-by-side on the proximal end side of the groove 5, the portion of the first branch stent 601 adjacent to the second branch stent 602, the portion of the second branch stent 602 adjacent to the first branch stent 601, and the inner wall of the main body stent 10 enclose a triangular region. This triangular region, when impacted by blood flow, will generate eddies, thereby affecting the flow direction of blood in the inner cavity of the main body stent 10. In this embodiment, the second branch support 602 is disposed outside the main support 10. The first branch support 601 and the second branch support 602 on the axial side of the groove 5 will not form a triangular region with the main support 10, thus reducing the impact on the blood flow direction in the inner cavity of the main support 10.
[0203] Please see Figure 31 In some embodiments, a guide segment 6012 is formed at the distal end of the first branch stent 601, and the cross-sectional area of the guide segment 6012 extends from the proximal end to the distal end in a gradually increasing manner. Designing the distal end of the first branch stent 601 as a funnel-shaped guide segment 6012 can guide the insertion of the guide wire or the external branch stent 300.
[0204] Please see Figure 33 For example, the proximal end of the grooved stent 100 is superior, and the distal end of the grooved stent 100 is inferior. The second branch stent 602 is disposed to the right of the first branch stent 601 to better accommodate the three branch vessels 200 near the aortic arch 300. The second branch stent 602 is used for implantation. Figure 1 The leftmost branch vessel 200, after the second branch stent 602 is implanted with the corresponding branch vessel 200, can play a certain role in positioning the groove stent 100, so that the groove 5 is aligned with the other two branch vessels 200. After the second branch stent 602 is implanted with the corresponding branch vessel 200, the second branch stent 602 will not interfere with the implantation of the corresponding external branch stent 300 in the other two branch vessels 200, nor will it interfere with the connection between the external branch stent 300 and the corresponding internal branch stent 8.
[0205] In some embodiments, the first branch bracket 601 may also be disposed outside the main body bracket 10. For example, one end of the first branch bracket 601 is fixedly connected to and communicates with the main body bracket 10, and the other end is a free end with a branch opening. The free end of the first branch bracket 601 is disposed outside the main body bracket 10. The length extension direction of the first branch bracket 601 intersects with the axial direction. The first branch bracket 601 and the second branch bracket 602 are arranged along the axial direction of the groove bracket 100 and disposed on the proximal section 2. Specifically, the first branch stent 601 and the second branch stent 602 are used to connect two branch vessels 200 respectively. After the first branch stent 601 and the second branch stent 602 connect the corresponding branch vessels 200, the groove 5 of the grooved stent 100 is aligned with the opening of the other branch vessels 200. This effectively reduces the possibility that the groove 5 is difficult to align with the corresponding branch vessel 200 due to the easy deflection of the grooved stent 100 during release. In addition, by placing the branch openings of the free ends of the first branch stent 601 and the second branch stent 602 outside the main stent 10, the first branch stent 601 and the second branch stent 602 can be implanted into the branch vessels 200 without occupying the space of the inner cavity of the main stent 10, thereby further reducing the occupation of the inner cavity of the main stent by the branch stents and further increasing the blood flow in the inner cavity of the main stent 10. In other embodiments, the grooved stent 100 also includes a third branch stent 83, which is disposed on the distal side of the groove 5. The third branch support 83 may be located outside the main support 10, as the second branch support 602; or the third branch support 83 may be located inside the cavity of the main support 10.
[0206] In other embodiments, the first branch bracket 601 and the second branch bracket 602 may also be located at the far end of the groove 5, and the third branch bracket 83 may be located at the near end of the groove 5.
[0207] The above specific embodiments are only some embodiments of the present invention and are not intended to limit the present invention. This specification cannot exhaustively describe all embodiments of the present invention concept, and some features of the different embodiments described above can be substituted for or combined with each other. Those skilled in the art can also make simple substitutions according to actual needs. The concept of the present invention is subject to the claimed protection scope.
Claims
1. A grooved bracket, characterized in that, include: The main support is tubular and has an inner cavity. The side of the main support is recessed towards the inner cavity to form a groove, and the groove includes a bottom. A support cover is connected to the main body bracket, and at least a portion of the support cover and the bottom of the groove form a radial gap in the radial direction of the groove bracket. The support cover has an arc-shaped structure in the circumferential direction of the groove bracket, and the support cover bulges away from the bottom of the groove. The support cover includes a mesh structure woven from braided yarns, and the mesh structure includes a plurality of deformable mesh holes that communicate the groove with the outside. The mesh structure includes a braiding start end and a braiding end end, which are fixed to each other by a fastener. The support cover includes a bent portion, the bent portion including a first rod and a second rod connected to each other, forming a bending angle between the first rod and the second rod, the first rod extending from the bending angle toward a direction near one axial end of the support cover, the second rod extending from the bending angle toward a direction near another axial end of the support cover, the first rod extending toward a direction near one radial edge of the support cover, and the second rod extending toward a direction near another radial edge of the support cover.
2. The grooved bracket according to claim 1, characterized in that, The fastener is located at the radial edge and / or axial edge of the support cover.
3. The grooved bracket according to claim 1, characterized in that, The groove includes an axial edge and a radial edge, and a corner is formed between the axial edge and the radial edge of the groove. The fastener includes a first axial end and a second axial end. The first axial end of the fastener is located at or near the corner of the groove, and the second axial end of the fastener is further away from the corner than the first axial end. The fastener is disposed along the radial edge of the groove.
4. The grooved bracket according to claim 3, characterized in that, The support cover includes an edge bevel located at the axial end, the edge bevel includes a vertex, the vertex of the edge bevel is connected to the corner of the groove, and the fastener is disposed on the edge bevel and located near the vertex of the edge bevel.
5. The grooved bracket according to claim 4, characterized in that, The edge bevel is connected to the hook unit, which includes a first hook and a second hook that are axially movable relative to each other.
6. The grooved bracket according to claim 1, characterized in that, The groove includes a radial edge, the radial edge of the groove has an inner wall, and the fastener is fixedly connected to the inner wall.
7. The grooved bracket according to claim 6, characterized in that, The fastener is sewn to the inner wall by sutures, and the sutures form multiple suture fixing points on the outer surface of the fastener.
8. The grooved bracket according to claim 6, characterized in that, The fixing component includes a fixing sleeve, which has an inner cavity. The braiding start end and the braiding end are fixed in the inner cavity of the sleeve. The braiding yarn segment adjacent to the braiding start end is designated as the first segment, and the braiding yarn segment adjacent to the braiding end is designated as the second segment. The first segment includes a first inner segment located inside the fixing sleeve and a first outer segment connected to the first inner segment and located outside the fixing sleeve. The second segment includes a second inner segment located inside the fixing sleeve and a second outer segment connected to the second inner segment and located outside the fixing sleeve. The first outer segment and / or the second outer segment are fixedly connected to the inner wall.
9. The grooved bracket according to claim 1, characterized in that, Along the circumference of the grooved bracket, the support cover includes a first mesh area and at least two second mesh areas respectively connected to both sides of the first mesh area; the second mesh area includes multiple spaced first direction support wires and multiple spaced second direction support wires, the first direction support wires and the second direction support wires overlap each other to form multiple rows of cross units and multiple rows of deformable mesh holes, and at least one of the fixing members is provided in the second mesh area.
10. The grooved bracket according to any one of claims 1 to 9, characterized in that, The groove includes a groove opening, and the axial distance between at least one of the fixing members and the proximal end of the groove opening is less than the axial distance between the fixing member and the distal end of the groove opening; or, the axial distance between at least one of the fixing members and the proximal end of the groove opening is greater than the axial distance between the fixing member and the distal end of the groove opening.
11. The grooved bracket according to claim 10, characterized in that, When the axial distance between the fixing member and the proximal end of the groove opening is less than the axial distance between the fixing member and the distal end of the groove opening, the ratio of the axial distance between the fixing member and the proximal end of the groove opening to the axial length of the groove opening is in the range of 5% to 15%; when the axial distance between the fixing member and the proximal end of the groove opening is greater than the axial distance between the fixing member and the distal end of the groove opening, the ratio of the axial distance between the fixing member and the distal end of the groove opening to the axial length of the groove opening is in the range of 5% to 15%.
12. The grooved bracket according to any one of claims 1 to 9, characterized in that, The starting end and the ending end of the braiding are fixed in the fixing member. The starting end and the ending end of the braiding are arranged opposite each other in the length direction of the braiding yarn. The starting end and the ending end of the braiding are either connected together or spaced apart.
13. The grooved bracket according to any one of claims 1 to 9, characterized in that, The grooved bracket also includes one or more branch brackets connected to the main bracket. All branch brackets are located inside the main bracket, or at least some branch brackets are located outside the main bracket.
14. A method for manufacturing a grooved bracket according to any one of claims 1 to 13, characterized in that, include: Provide main frame and support cover; Connect the support cover to the main bracket; The method for manufacturing the support cover includes: Provides braiding yarn, The braided yarns are woven through multiple paths to form a mesh structure, the mesh structure including a braiding start end and a braiding end end; The starting and ending ends of the braided yarn are fixed together by a fastener.
15. The method for manufacturing the grooved bracket according to claim 14, characterized in that, The mesh structure is woven integrally from the braided yarns, and the mesh structure has only one braiding start end and one braiding end.
16. The method for manufacturing the grooved bracket according to claim 14, characterized in that, The plurality of paths includes a plurality of first-direction paths and a plurality of second-direction paths, and the step of weaving the braided yarns through the plurality of paths to form a mesh structure includes: Step A: Weave along the first directional path to form a first directional weave unit; Step B: Weave along the second direction path to form a second direction weave unit; Steps A and B are repeated alternately until a mesh structure is formed, wherein the first direction weaving unit and the second direction weaving unit are alternately formed and connected to each other, and at least one intersection point is formed between adjacent first direction weaving units and second direction weaving units.