Knitted covered stent with support layer interaction

By interweaving the support layer and the flow-blocking layer and using a knitted membrane design, the problems of incomplete wall apposition and insufficient flexibility in the treatment of large aneurysms in existing technologies are solved, achieving long-term stability and high-efficiency treatment results for the stent.

CN224403822UActive Publication Date: 2026-06-26SHANGHAI LEE KAI TECH CO LTD

Patent Information

Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
SHANGHAI LEE KAI TECH CO LTD
Filing Date
2024-12-23
Publication Date
2026-06-26

AI Technical Summary

Technical Problem

Existing technologies for treating large and giant saccular aneurysms, wide-necked aneurysms, fusiform and dissecting aneurysms have problems such as long intraoperative time, incomplete aneurysm occlusion, high postoperative complication rate and incomplete wall apposition, especially the insufficient braiding density and flexibility of the blood flow diversion device.

Method used

A knitted film-coated support structure with interactive support layers was designed. The support layer and the flow-blocking layer are interwoven and connected. The structure is made of metal wire with shape memory effect. The support layer and the flow-blocking layer are covered with components such as cross-layer interweaving, hollow round tubes or C-shaped rings to achieve a tight connection. The support layer is woven and the flow-blocking layer is knitted, forming a support structure with a woven structure + knitted structure, which enhances the wall adhesion and conformability.

Benefits of technology

It improves the stent's apposition and compliance, enabling it to better adapt to changes in vascular morphology, reduce the risk of interlaminar separation, increase the aneurysm occlusion rate and reduce ischemic complications, and enhance the stability and reliability of the stent.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application relates to a knitted film-covered stent with support layer interaction, which comprises a support layer and a flow resistance layer. The support layer is knitted by knitting units in two knitting directions, and any adjacent knitting units with different knitting directions are interwoven to form a hollow columnar knitting structure. The flow resistance layer is a knitting unit, which is continuously knitted into a net through a knitting process, covers the knitting structure outside the support layer, and is attached to the outside of the support layer. The support layer and the flow resistance layer have an interlayer connection structure, which realizes the interlayer connection and fixation of the support layer and the flow resistance layer. Compared with the traditional cutting framework + polymer film design, the knitted film-covered stent has better wall adhesion and compliance, can better adapt to the shape and changes of blood vessels, and thus improves the implantation effect and treatment effect of the stent.
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Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a knitted covered stent with support layer interaction. Background Technology

[0002] Minimally invasive interventional surgery is a common treatment for intracranial aneurysms. Currently, commonly used techniques for treating intracranial aneurysms include coil embolization, stent-assisted coil embolization, flow diverter placement, and covered stent implantation. For large and giant saccular aneurysms, wide-necked aneurysms, fusiform aneurysms, and dissecting aneurysms, the use of traditional coil or stent-assisted coil embolization techniques can lead to prolonged intraoperative time, incomplete aneurysm occlusion, and a high postoperative complication rate. Flow diverters, due to their high braid density, may also have issues with incomplete apposition to the aneurysm wall and flexibility, which can affect the postoperative aneurysm occlusion rate and the occurrence of ischemic complications. Summary of the Invention

[0003] In view of this, this application proposes a knitted film scaffold with support layer interaction.

[0004] According to one aspect of this application, a knitted coated scaffold with support layer interaction is provided, comprising: a support layer and a flow-blocking layer.

[0005] The support layer is made of braided units woven along the axial direction, and any adjacent braided units with different braiding directions interweave with each other to form a hollow column braided structure;

[0006] The flow-blocking layer is a knitted unit, which is formed by looping and continuously knitting into a net through a knitting process. It is a knitted structure covering the outside of the support layer. The inner side of the flow-blocking layer is attached to the outer side of the support layer. The knitted units of the support layer are inserted into the flow-blocking layer, or adjacent knitted units of the support layer and the flow-blocking layer are connected together by metal rings to form an interlayer connection structure between the support layer and the flow-blocking layer, thereby achieving the interlayer connection and fixation between the support layer and the flow-blocking layer.

[0007] In one possible implementation, at least one knitting unit of the support layer extends out of the knitting structure of the flow-blocking layer along the knitting mesh, and then inserts into the knitting structure of the flow-blocking layer along the knitting mesh, forming an interlayer connection structure between the support layer and the flow-blocking layer, thereby achieving interlayer connection and fixation between the support layer and the flow-blocking layer.

[0008] In one possible implementation, the braided units of the support layer and the braided units of the flow-blocking layer are connected together by a metal ring to form an interlayer connection structure between the support layer and the flow-blocking layer, thereby achieving a fixed interlayer connection between the support layer and the flow-blocking layer.

[0009] In one possible implementation, two adjacent braided units with different braiding directions in the support layer continue to be twisted along the circumference or axial direction of the support after interlacing at the same interlacing point. The twisting direction is clockwise or counterclockwise, and after twisting, an interaction point of the support layer is formed.

[0010] The interaction points of the support layer are arranged along the circumference and axial direction of the support layer.

[0011] In one possible implementation, two adjacent braided units with different braiding directions are twisted along the axial direction of the support, or twisted in an axial direction perpendicular to the support.

[0012] In one possible implementation, the twisting angle between the first braiding unit 121 and the second braiding unit 122 is α;

[0013] α = n * 180°, 1 ≤ n ≤ 10.

[0014] In one possible implementation, the flow-blocking layer can be woven using warp knitting or weft knitting techniques.

[0015] In one possible implementation, the length of the support layer in the axial direction of the support is greater than the length of the flow-blocking layer in the axial direction of the support.

[0016] In one possible implementation, the outer diameter of the support layer is smaller than the outer diameter of the flow-blocking layer.

[0017] In one possible implementation, the number of heads in the support layer is 2m, where 4 ≤ m ≤ 48, and the number of heads in the flow-blocking layer is n, where n ≥ 1.

[0018] In one possible implementation, the interlayer connection structure is laid out at a frequency of a in the circumferential direction of the support, 1≤a≤2m, and the interlayer connection point is laid out at a frequency of b in the axial direction of the support, b=x*p, where p is the weaving layer pitch and x>0.

[0019] The beneficial effects of the knitted covered stent with support layer interaction in this application embodiment are as follows: The knitted covered stent with support layer interaction uses a support layer as the core carrier and a flow-blocking layer as the covering layer. The support layer and the flow-blocking layer are wrapped with support layer wires and flow-blocking layer wires using cross-layer interlacing, hollow circular tubes, or C-rings, or directly using welding, impregnation, or adhesive bonding to achieve a tight and firm connection between the support layer and the flow-blocking layer at certain locations. This can prevent interlayer separation problems that may occur during stent use, thereby ensuring the long-term stability and reliability of the stent. Compared with traditional covered stents, the flow-blocking layer in this invention is not merely a thin film without mechanical properties; both the flow-blocking layer and the support layer are carefully made using metal wires with shape memory effect. Furthermore, the support layer is woven, and the flow-blocking layer is knitted, resulting in a knitted covered stent with a woven structure + knitted structure support layer interaction. Compared with the traditional cut skeleton + polymer membrane design, this exhibits superior wall adhesion and compliance, and can better adapt to the morphology and changes of blood vessels, thereby improving the stent implantation effect and treatment effect.

[0020] Other features and aspects of this application will become clear from the following detailed description of exemplary embodiments with reference to the accompanying drawings. Attached Figure Description

[0021] The accompanying drawings, which are included in and form part of this specification, illustrate exemplary embodiments, features, and aspects of this application together with the specification and serve to explain the principles of this application.

[0022] Figure 1 (a) A schematic diagram of the main structure of a knitted film-coated support frame with support layer interaction according to an embodiment of the present application, wherein two adjacent knitting units with different knitting directions are twisted around the circumference of the support frame to form support layer interaction points.

[0023] Figure 1 (b) A schematic diagram of the main structure of the knitted film-coated support frame with support layer interaction according to an embodiment of the present application, wherein two adjacent knitting units with different knitting directions are twisted along the support axis to form support layer interaction points;

[0024] Figure 2 This diagram illustrates a support layer braiding unit that interweaves inside and outside the flow barrier layer, forming an interlayer connection structure where the support layer and the flow barrier layer are nested together, according to an embodiment of this application.

[0025] Figure 3 This diagram shows the main structure of the weft-knitted structure of the flow-blocking layer according to an embodiment of this application.

[0026] Figure 4 This diagram shows the main structure of the warp-knitted structure of the flow-blocking layer according to an embodiment of this application.

[0027] Figure 5 This diagram illustrates the structure of the support layer braiding unit as braided strands in an embodiment of this application.

[0028] Figure 6 This illustration shows a cross-sectional structure of a hollow cylindrical or C-shaped metal ring connecting the support layer and the flow-blocking layer to form an interlayer connection structure according to an embodiment of this application.

[0029] Figure 7 This is a schematic diagram of the overall structure of the bracket, showing the interlayer connection structure between the metal ring connecting the support layer and the flow-blocking layer according to an embodiment of this application.

[0030] Figure 8 This diagram shows a winding structure of the support layer closed winding group structure according to an embodiment of this application;

[0031] Figure 9 This diagram illustrates a method for fixing a closed wire take-up assembly structure of the support layer according to an embodiment of this application.

[0032] Figure 10 This diagram illustrates the structural schematic of the support layer end portion bundle termination according to an embodiment of this application.

[0033] Figure 11 This diagram illustrates the structure of the support layer end wrapping back according to an embodiment of this application.

[0034] Figure 12 This is a schematic diagram showing the structure of the support layer end portion bundle termination and end wrapping staggered arrangement according to an embodiment of this application;

[0035] Figure 13 This is a schematic diagram showing the structure of the loose wire end connection and fixation of the flow-blocking layer according to an embodiment of this application. Detailed Implementation

[0036] Various exemplary embodiments, features, and aspects of this application will now be described in detail with reference to the accompanying drawings. The same reference numerals in the drawings denote elements that have the same or similar functions. Although various aspects of the embodiments are shown in the drawings, they are not necessarily drawn to scale unless specifically indicated otherwise.

[0037] It should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention or simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention.

[0038] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0039] The term “exemplary” as used herein means “serving as an example, embodiment, or illustration.” Any embodiment illustrated herein as “exemplary” is not necessarily to be construed as superior to or better than other embodiments.

[0040] Furthermore, to better illustrate this application, numerous specific details are provided in the following detailed embodiments. Those skilled in the art should understand that this application can be implemented without certain specific details. In some instances, methods, means, components, and circuits well-known to those skilled in the art have not been described in detail in order to highlight the main points of this application.

[0041] like Figures 1-13 As shown, the knitted film-coated support structure with support layer interaction in this embodiment includes a support layer 120 and a flow-blocking layer 110. The support layer is a knitted structure formed by knitting units along the circumferential or axial direction, with knitting units of any adjacent knitting direction being interwoven to form a hollow column. The support layer 120 serves as the basic skeleton of the support 10, providing necessary mechanical support. The flow-blocking layer 110 is a knitted structure covering the outside of the support layer 120. The flow-blocking layer 110 is a knitted structure formed by knitting metal wires using a finer knitting process. The inner side of the flow-blocking layer 110 is attached to the outer side of the support layer 120. The interlayer connection structure can be formed by inserting the knitting units of the support layer 120 into and out of the knitted structure of the flow-blocking layer 110, or by connecting the knitting units of the support layer 120 and the flow-blocking layer 110 together with metal rings, thereby achieving the interlayer connection between the support layer 120 and the flow-blocking layer 110.

[0042] In this embodiment, the knitted coated scaffold 10 with interlocking support layers uses a support layer 120 as the core carrier and a flow-blocking layer 110 as the coating layer. The support layer 120 and the flow-blocking layer 110 are wrapped with interlocking, hollow tubes, or C-rings or other annular components, or directly welded, dipped, or glued, to achieve a tight and firm connection between the support layer 120 and the flow-blocking layer 110 at certain locations. This can prevent interlayer separation problems that may occur during the use of the scaffold 10, thereby ensuring the long-term stability and reliability of the scaffold 10. Compared with traditional coated scaffolds 10, the flow-blocking layer 110, which is the coating layer in this invention, is not merely a thin film without mechanical properties. Both the flow-blocking layer 110 and the support layer 120 are carefully made of metal wires with shape memory effect. In addition, the support layer 120 is woven and the flow-blocking layer 110 is knitted, resulting in a knitted covered stent 10 with an interaction of woven structure and knitted structure support layer. Compared with the traditional cut skeleton + polymer membrane design, it exhibits superior wall adhesion and compliance, and can better adapt to the shape and changes of blood vessels, thereby improving the implantation effect and treatment effect of stent 10.

[0043] Furthermore, the application of knitted structures as a coating layer offers greater flexibility and adaptability compared to traditional polymer membranes. By cleverly combining knitted loops of different sizes, especially by designing large knitted loops at the branch vessel coverage, the problem of branch vessel occlusion can be effectively avoided.

[0044] In one specific embodiment, the support layer 120 includes a first braided unit 121 arranged along a first braiding direction and a second braided unit 122 arranged along a second braiding direction. The braided units in the two directions interweave to form a hollow columnar structure. Any adjacent first braided unit 121 and second braided unit 122, after being twisted along the circumference or axial direction of the stent, form a support layer interaction point 130. The first braided unit 121 and second braided unit 122 are braided along the original braiding direction or along the braiding direction of another braided unit. In this way, the first braided unit 121 and the second braided unit 122 interweave and twist to construct a hollow columnar structure. These support layer interaction points 130 are not randomly distributed, but are arranged at intervals along the circumference and axial direction of the stent according to a certain pattern. While improving the stent's wall apposition ability, it also optimizes the overall flexibility of the stent, enabling it to maintain good compliance and wall apposition effect when facing tortuous and complex vascular structures, thus ensuring the effectiveness and safety of treatment.

[0045] Furthermore, in this specific embodiment, the twisting angle between the first braiding unit 121 and the second braiding unit 122 is α, where α = n * 180°, 1 ≤ n ≤ 10. When n is odd, the braiding direction of both adjacent braiding units changes; when n is even, both adjacent braiding units continue braiding along their original braiding direction. Here, n is the number of times the first braiding unit 121 and the second braiding unit 122 twist immediately after forming an interlacing point during normal braiding. During the braiding process of the support body 10, the number of twists at the support layer interaction point 130 is approximately 1-3 times per instance, avoiding excessive rigidity of the first braiding unit 121 and the second braiding unit 122 at the interaction position, which could affect the overall rigidity and opening degree of the support.

[0046] In this structure, the first braiding unit 121 and the second braiding unit 122 are twisted and interwoven to form support layer interaction points 130, which are arranged along the circumference and axial direction of the stent. Multiple support layer interaction points 130 are formed by twisting along the circumference and axial direction of the support layer. In the circumference direction, the support layer interaction points 130 ensure the stable maintenance of the circumferential structure of the support layer, effectively resisting radial pressure from the blood vessel wall. In the axial direction, the support layer interaction points 130 enhance the longitudinal continuity of the support layer, enabling it to better adapt to the curvature and extension of the blood vessel.

[0047] In one specific embodiment, two adjacent braided units with different braiding directions are twisted along the axial direction of the support 10 or in a direction perpendicular to the axial direction of the support 10, which enhances the strength and stability of the support layer 120 and provides multi-dimensional rotational flexibility, enabling it to meet more diverse application needs.

[0048] In one specific embodiment, at least one braided unit of the support layer 120 extends out of the braided structure of the flow-blocking layer 110 and then inserts into the braided structure of the flow-blocking layer 110 to form an interlayer connection structure 200 between the support layer 120 and the flow-blocking layer 110. By interlacing the metal wires of the support layer 120 within and outside the flow-blocking layer 120 at local locations of the support 10, the flow-blocking layer 110 and the support layer 120 are nested together, increasing the resistance to deformation near the interlayer connection structure 200. After external force is applied, the nesting between the flow-blocking layer 110 and the support layer 120 near these interlayer connection structures 200 avoids the risk of interlayer separation due to the difference in deformation recovery capabilities between the flow-blocking layer 110 and the support layer 120 after the external force is released. Even if the flow-blocking layer 110 and the support layer 120 are displaced to a certain extent when external force is applied, the metal wires of the flow-blocking layer 110 can quickly return to their original positions under the influence of the relatively rigid support layer 120, further resisting the risk of local delamination of the support 10. The interlayer connection structures 200 distributed throughout the support 10 further increase the overall resistance to delamination of the support 10.

[0049] Furthermore, in this specific embodiment, there is an interlayer connection structure 200 between the metal wires of the support layer 120 and the flow-blocking layer 110. Multiple interlayer connection structures 200 are evenly distributed along the circumference and axial direction of the coated support 10. Specifically, multiple interlayer connection structures are evenly distributed along the circumference and axial direction of the support 10, ensuring the stability and uniformity of the support 10 in its overall structure. This enhances the mechanical strength of the support 10, enabling it to better withstand forces from all directions, and also improves the durability and reliability of the support 10.

[0050] Furthermore, by having the metal wires of the support layer 120 interwoven with the flow-blocking layer 110, the support layer 120 and the flow-blocking layer 110 are nested together, connecting the braided layer and the knitted layer together, which can prevent the separation of the two layers of the support 10 during use.

[0051] In one specific embodiment, the support layer 120 includes braided units arranged along a first braiding direction and braided units arranged along a second braiding direction, the braided units in the two braiding directions interweaving to form a hollow columnar structure. The support layer 120 is formed by the interweaving of braided units arranged in the first and second braiding directions, and at least one braided unit is composed of two or more parallel metal wires or braided strands twisted clockwise or counterclockwise, such as... Figure 5 The metal braided strands formed by clockwise or counterclockwise metal wires, compared to those prepared by conventional methods using a single metal wire, improve the rigidity of the support layer 120 of this application and provide better resistance to lumen collapse.

[0052] In one specific embodiment, the weaving method of the flow-blocking layer 110 includes warp knitting or weft knitting. The warp direction refers to the direction in which the woven fabric is ultimately formed, while the weft direction refers to the direction perpendicular to the formation of the woven fabric. The warp direction of the flow-blocking layer 110 is parallel to the axial direction of the support 10, and the weft direction of the flow-blocking layer 110 is concentric with the circumferential direction of the support 10. The main advantages of warp knitting include: good warp dimensional stability. The warp-knitted flow-blocking layer 110 is formed by one or more sets of parallel metal wires or braided strands simultaneously looped along the axial direction of the support, resulting in very stable warp dimensions, a soft texture, and good shape retention. The main advantages of weft knitting include: good weft elasticity. The flow-blocking layer 110 is formed by one or more metal wires or braided strands looped along the circumferential direction of the support, resulting in excellent circumferential elasticity, making it suitable for producing flow-blocking layers 110 requiring greater stretchability.

[0053] In one specific embodiment, the length of the support layer 120 in the axial direction of the stent 10 is greater than the length of the flow-blocking layer 110 in the axial direction of the stent 10. Both the support layer 120 and the flow-blocking layer 110 are hollow cylindrical structures. Since the flow-blocking layer 110 is coaxially arranged on the support layer 120, the longer axial length of the support layer 120 can provide a wider range of support, ensuring that the stent 10 can firmly adhere to and support the blood vessel wall after implantation, especially at the bends or branches of the blood vessel, thereby enhancing the adaptability and stability of the stent 10 and effectively blocking or regulating blood flow without sacrificing the overall structural integrity of the stent 10.

[0054] Furthermore, the support layer 120 and the flow-blocking layer 110 are independent of each other. The metal wires or braided strands of the support layer 120 are connected to the metal wires or braided strands of the flow-blocking layer 110 by a metal ring to form an interlayer connection structure 200, which connects the support layer 120 and the flow-blocking layer 110 together, thus avoiding possible interlayer separation of the two layers of the support 10 during use.

[0055] Furthermore, the difference in axial length between the support layer 120 and the flow-blocking layer 110 helps to better adapt to changes in blood vessels during stent implantation, reducing implantation difficulty and improving surgical success rate.

[0056] Since the flow-blocking layer 110 is coaxially arranged on the support layer 120, the outer diameter of the support layer 120 is smaller than the outer diameter of the flow-blocking layer 110.

[0057] In one specific embodiment, the number of heads in the support layer 120 is 2m, where 4 ≤ m ≤ 48, and the number of heads in the flow-blocking layer 110 is n, where n ≥ 1.

[0058] In one specific embodiment, the interlayer connection structure 200 is arranged at a frequency of 1 ≤ a ≤ 2 m in the circumferential direction of the support 10, and the interlayer connection point 200 is arranged at a frequency of 1 ≤ a ≤ 2 m in the axial direction of the support 10 at a frequency of b, b = x * p, where p is the weaving layer pitch and x > 0.

[0059] In one specific embodiment, the metal coverage of the support layer 120 of the stent 10 is in the range of 10% to 40%, and the mesh size of the choke layer 110 is in the range of 20 micrometers to 200 micrometers. The support layer 120 provides sufficient mechanical support, while the choke layer 110 provides the function of blocking blood flow, reducing the impact of blood flow on the aneurysm wall. The two work together to achieve the therapeutic effect on the aneurysm. The mesh size of the choke layer 110 is set in the range of 20 micrometers to 200 micrometers to ensure that the choke layer 110 can effectively block or regulate blood flow, while allowing necessary fluid to pass through to maintain the normal physiological function of branch vessels. The appropriate mesh size helps to reduce the stimulation of the vessel wall by the stent 10, reduce the risk of inflammatory response, and thus promote patient recovery.

[0060] In one specific embodiment, a clamping ring is provided at the position adjacent to the metal wire of the support layer 120 and the metal wire of the flow blocking layer 110. The clamping ring is a hollow C-shaped metal ring that covers the outside of the metal wires of the support layer 120 and the metal wires of the flow blocking layer 110, forming an interlayer connection structure. Multiple interlayer connection structures formed theretherein are arranged in a certain pattern along the circumference and axial direction of the support. The C-shaped metal ring connects the support layer 120 and the flow blocking layer 110 together, avoiding possible interlayer separation between the two layers during use.

[0061] Furthermore, the hollow-structured pressure-gripping ring is a cylindrical structure with an internal hollow interior and open ends, which is welded to the outside of the metal wires of the support layer 120 and the flow-blocking layer 110.

[0062] The C-shaped metal ring's gripping ring is a hollow, open-end cylindrical structure with a C-shaped cross-section. It can directly snap onto the metal wires covering the support layer 120 and the flow-blocking layer 110. This tight wrapping not only enhances the strength of the connection point but also effectively prevents interlayer delamination that may occur near the interlayer connection structure during use, thus greatly improving the reliability and safety of the stent 10. Furthermore, the gripping ring firmly connects the support layer 120 and the flow-blocking layer 110 together through the metal ring. This metal ring connection method is not only robust and durable but also distributes stress evenly, avoiding damage to the stent 10 caused by localized stress concentration. It provides continuous and stable support and treatment for patients, both in complex vascular environments and during long-term use.

[0063] In one specific embodiment, the metal wire is a material with shape memory properties such as nickel-titanium or cobalt-chromium, or a DFT metal wire containing radiopaque components, or a mixture of shape memory metal wires such as nickel-titanium or cobalt-chromium with radiopaque metal wires such as platinum-tungsten or platinum-iridium.

[0064] In one specific embodiment, the metal ring used in the stent has a hollow structure and is made of materials such as ordinary stainless steel that are not radiolucent under X-rays, or radiolucent metal materials such as platinum-tungsten, platinum-iridium, and platinum-nickel containing radiolucent components.

[0065] In one specific embodiment, the outer diameter of the covered stent 10 is in the range of 1.5 to 12 mm, and the length is in the range of 10 to 80 mm.

[0066] In one specific embodiment, the metal wires of the support layer 120 and the flow-blocking layer 110 have one or more wire diameters, and the wire diameter ranges from 0.0005 inches to 0.005 inches. The wire diameter of the metal wires of the support layer 120 is greater than or equal to the wire diameter of the metal wires of the flow-blocking layer 110.

[0067] In one specific embodiment, the support layer 120 of the knitted covered stent 10 with interlocking support layers has a straight section structure, and the two axial ends of the support layer 120 have a flared structure, which improves the opening and anchoring ability of the stent 10. The flared structure of the support layer 120 at both ends not only gives the stent 10 a stronger expansion capacity in the end region, making it easier for the stent 10 to open and conform to the blood vessel wall during implantation, thereby effectively reducing the difficulty of implantation and the risk of complications, but also significantly improves the anchoring performance of the stent 10, ensuring that the stent 10 can be firmly fixed in the required position, avoiding potential problems such as displacement or dislodgement, and further enhancing the safety and reliability of treatment.

[0068] Furthermore, the end of the support layer 120 of the knitted film-coated support 10 with support layer interaction can be a closed structure formed by winding, bundling and taking in the yarn, or binding the loose yarn together by mechanical snapping, welding, bonding, cylindrical hollow tube or C-ring, etc.

[0069] The two ends of the support layer 120 can be bound together by a fully enclosed or partially enclosed winding method. The enclosed winding technique involves: at the start or end of weaving, the total number of yarn ends w participating in the weaving is first divided into η groups of metal wires, with each group containing yarn ends w / η, where η can be 3, 4, 6, 8, 10, or 12; ε groups are further divided into two bundles, where ε is a natural number greater than 0 and ε ≤ η; the two bundles rotate in the same or opposite directions to form a stable yarn bundle, and then the two bundles are bound together in parallel to form a closed winding group. The characteristics of the closed winding group are as follows: Figure 8 As shown, they are fixed together by means of dispensing, welding, etc. (A metal ring can be fitted on the outside to avoid insufficient adhesion or welding strength). The support layer 120 of the knitted film-coated support 10 with interactive support layers has a closed or loose structure at its ends. The closed structure can be achieved by methods such as back-winding, bundling and finishing, welding, and bonding. The back-winding and finishing structures can be threaded between the loops at the ends of the knitted layers. The support layer 120 is bundled and finished as follows: Figure 10 A schematic diagram of the axial winding is shown below. Figure 11 As shown. Based on the above, the splitting and wrapping can be aligned or staggered. The staggered arrangement effect is as follows. Figure 12 As shown. The flow-blocking layer 110 of the knitted coated support 10 with support layer interaction, as... Figure 13 It can be fixed by methods such as dispensing and welding, or wrapped around the braided wires of the support layer 120; in addition, to further enhance the stability and reliability of the connection, auxiliary components such as hollow rings, C-rings, and various irregularly shaped rings can be used. These components are secured by appropriate external pressure, mechanical clamping, or by advanced processes such as dispensing and welding. Figure 6 .

[0070] Based on the above, at the start or end of weaving, the total number of yarn ends w is first divided into η groups of metal wires, with each group containing w / η, where η can be 3, 4, 6, 8, 10, or 12. ε groups are further divided into two bundles, where ε is a natural number greater than 0 and ε ≤ η. The two bundles of metal wires rotate in the same or opposite directions to form a stable bundle, which is then bound together in parallel to form a take-up group.

[0071] In one specific embodiment, the wire take-up assembly of the support layer 120 can be fixed by welding.

[0072] In one specific embodiment, the end of the support layer 120 contains ε hollow tubes of precious metal that are opaque to X-rays. The hollow tubes of precious metal can be connected to the metal wire by means of bonding, welding or mechanical pressing.

[0073] In one specific embodiment, the end of the support layer 120 may adopt a full or partial winding structure design, dividing the w metal wires into w / 2 groups, with two adjacent metal wires having different directions of rotation forming a winding group.

[0074] In one specific embodiment, both the take-up group and the rewinding group can be staggered.

[0075] In one specific embodiment, the flow-blocking layer 110 of the knitted coated support 10 with interlocking support layers has loosely knitted yarn ends at its ends, such as... Figure 13 It can be fixed by methods such as dispensing and welding, or wrapped around the braided wires of the support layer 120; in addition, to further enhance the stability and reliability of the connection, auxiliary components such as hollow rings, C-rings, and various irregularly shaped rings can be used. These components are secured by appropriate external pressure, mechanical clamping, or by advanced processes such as dispensing and welding. Figure 6 This ensures a strong and tight connection between the knitted yarn ends of the flow-blocking layer 110 and the support structure, improving the overall performance of the support 10 and ensuring its stability and durability in complex environments.

[0076] The various embodiments of this application have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles, practical application, or improvement of the technology in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.

Claims

1. A knitted coated scaffold with interlocking support layers, characterized in that, include: Support layer and flow barrier layer The support layer has a hollow columnar woven structure. After any adjacent woven units with different woven directions interweave to form woven points, they continue to be woven along the circumference or axial direction of the support layer. The flow-blocking layer is a knitted unit, which is formed into loops and continuously woven into a net by a knitting process. It is a knitted structure that covers the outside of the support layer. The inner side of the flow-blocking layer is attached to the outer side of the support layer, and there is an interlayer connection structure between the support layer and the flow-blocking layer to achieve interlayer connection and fixation between the support layer and the flow-blocking layer.

2. The knitted film-coated scaffold with interactive support layers according to claim 1, characterized in that, At least one knitting unit of the support layer extends out of the knitting structure of the flow-blocking layer along the knitting mesh, and then inserts into the knitting structure of the flow-blocking layer along the knitting mesh, forming an interlayer connection structure between the support layer and the flow-blocking layer.

3. The knitted coated scaffold according to claim 1, characterized in that, Between the support layer and the flow-blocking layer, the braided units of the adjacent support layer and the braided units of the flow-blocking layer are connected together by metal rings to form an interlayer connection structure between the support layer and the flow-blocking layer.

4. The knitted film-coated scaffold with support layer interaction according to claim 1, characterized in that, Two adjacent braided units with different braiding directions continue to twist along the circumference or axis of the support after interlacing at the same interlacing point. The twisting direction is clockwise or counterclockwise, and after twisting, a support layer interaction point is formed. The interaction points of the support layer are arranged along the circumference and axial direction of the support layer.

5. The knitted coated scaffold with support layer interaction according to any one of claims 1-4, characterized in that, The support layer includes a first braided unit arranged along a first braiding direction and a second braided unit arranged along a second braiding direction, wherein the twisting angle between the first braided unit and the second braided unit is α; α=n 180°, 1≤n≤10. When n is odd, the weaving direction of two adjacent knitting units changes. When n is even, the weaving direction of two adjacent knitting units continues to be woven along the original weaving direction.

6. The knitted coated scaffold with support layer interaction according to claim 1, characterized in that, The flow-blocking layer can be woven from woven units using warp knitting or weft knitting processes.

7. The knitted film-coated scaffold with interactive support layers according to claim 1, characterized in that, The axial length of the support layer in the bracket is greater than the axial length of the flow-blocking layer in the bracket.

8. The knitted coated scaffold with support layer interaction according to claim 1, characterized in that, The outer diameter of the support layer is smaller than the outer diameter of the flow-blocking layer.

9. The knitted coated scaffold with support layer interaction according to claim 3, characterized in that, The number of support layers is 2m, and 4≤m≤48; The number of flow-blocking layers is n, where n ≥ 1.

10. The knitted coated scaffold with support layer interaction according to claim 3, characterized in that, The interlayer connection structure is arranged circumferentially on the support with a frequency of a, where 1≤a≤2m; The interlayer connection point is located at the axial frequency of the support, where b = x. p, where p is the weave layer pitch, and x > 0.