A double-layer stent with a film
By employing a double-layer stent structure and lead wire adjustment design, the problems of difficult delivery, internal leakage, and non-adjustable coverage of covered stents are solved, achieving adjustability of the covered stent and flexibility of the stent, thereby improving the safety and effectiveness of the surgery.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SHANGHAI LEE KAI TECH CO LTD
- Filing Date
- 2025-06-19
- Publication Date
- 2026-06-09
AI Technical Summary
Existing covered stents have problems such as insufficient delivery performance, stent intubation, poor compliance and non-adjustable coverage, which lead to difficult surgical operation, high risk of vascular injury and complications.
The system employs a double-layer stent structure, including a first stent layer and a second stent layer, with the coating sandwiched between the two layers. The coating position is adjusted via a lead wire, and imaging points are marked under X-ray, enabling the adjustment of the coating length and position, thereby enhancing the flexibility and operational flexibility of the stent.
It improves the fixation of the endothelial graft, reduces the risk of endoleak, simplifies the procedure, reduces vascular damage and complications, and increases the success rate of the surgery.
Smart Images
Figure CN224331085U_ABST
Abstract
Description
Technical Field
[0001] This utility model belongs to the field of medical device technology, specifically relating to a membrane-covered double-layer stent. Background Technology
[0002] Minimally invasive interventional surgery is an important means of treating intracranial aneurysms, arteriovenous fistulas, and vascular defects. Among existing technologies, covered stents are a key device that achieves immediate therapeutic effects by blocking abnormal blood flow, but their clinical application still faces significant challenges.
[0003] Current mainstream covered stent technology has the following core defects:
[0004] Insufficient delivery capacity: Traditional covered stents, due to their complex structure or high rigidity, have difficulty passing through tortuous intracranial blood vessels, leading to difficult surgical procedures, prolonged operation time, and increased patient risks.
[0005] Intrastrap leakage: If the graft and stent are not tightly bonded, they are prone to displacement or separation under the impact of blood flow, causing blood to seep into the aneurysm cavity and reducing the effectiveness of treatment.
[0006] Poor compliance: Insufficient adaptation of the stent to the morphology of the blood vessel can easily lead to damage to the vessel wall or incomplete apposition, which in turn affects the long-term efficacy and increases the risk of thrombosis.
[0007] Risk of perforator occlusion: The coverage area of the endovascular membrane is fixed and cannot be flexibly adjusted according to the lesion morphology, which may compress branch vessels and lead to ischemic complications.
[0008] For example, existing single-layer covered stents mostly use a single stent structure, and the cover is fixed by simple adhesion or suturing, which is prone to peeling due to hemodynamic effects or vascular tortuosity. In addition, the design of the non-adjustable cover position limits the surgeon's flexibility during operation, especially in complex lesions (such as wide-necked aneurysms or vascular bifurcation sites), making it difficult to accurately cover the target area, resulting in perforator occlusion or aneurysm residue.
[0009] The aforementioned technical deficiencies severely restrict the clinical applicability and therapeutic efficacy of covered stents. Therefore, there is an urgent need for a novel covered double-layer stent design to address issues such as insecure fixation, difficult delivery, insufficient compliance, and non-adjustable coverage in existing technologies, thereby improving surgical success rates and reducing the risk of complications. Utility Model Content
[0010] This invention provides a covered double-layer stent, which aims to make the stent's covering length and position adjustable, thereby greatly reducing the possibility of the covered stent occluding vascular perforators and giving clinicians more room for maneuver.
[0011] This utility model provides a film-coated double-layer stent, the technical solution of which is as follows: it includes a first stent layer and a second stent layer, both of which are self-expanding structures. The first stent layer is sleeved outside the second stent layer, and a film is provided between the first stent layer and the second stent layer. The length and position of the film are adjustable, and the film is provided with at least one lead wire. The lead wire is used to adjust the position of the film in the stent. A release point is provided between the lead wire and the film. After the adjustment is completed, the lead wire can be detached from the film and removed.
[0012] Furthermore, the first support layer can be a laser-engraved support or a woven support, and the second support layer can be a laser-engraved support or a woven support.
[0013] Furthermore, the materials of the first support layer and the second support layer are selected from any one of nickel-titanium alloy, stainless steel, or cobalt-chromium alloy.
[0014] Furthermore, the coating material is selected from any one of expanded polytetrafluoroethylene, polyurethane, or polyethylene terephthalate.
[0015] Furthermore, the coating covers part or all of the surface of the second support layer.
[0016] Furthermore, the film has developing points at both ends for marking the film position under X-ray.
[0017] Furthermore, the coating is secured by the clamping force between the first support layer and the second support layer.
[0018] Furthermore, the lead wire and the coating are fixed by any one of bonding, welding or sewing.
[0019] The beneficial effects of this utility model are:
[0020] 1. This utility model utilizes the synergistic effect of a double-layer stent structure (laser-engraved stent, braided stent, or a combination thereof) to firmly clamp the membrane between the two stent layers, effectively reducing the internal leakage problem caused by the separation of the membrane from the stent and improving the blood flow blocking effect.
[0021] 2. Inheriting the flexibility and easy delivery characteristics of the expandable stent, the double-layer design further optimizes the stent's bending adaptability, making it easier to pass through tortuous intracranial blood vessels, reducing the difficulty of intraoperative operation and the risk of vascular injury.
[0022] 3. The endovascular membrane is equipped with a lead and contrast point, allowing the physician to precisely control the coverage area by adjusting the lead, avoiding compression of perforating vessels and significantly reducing the incidence of postoperative ischemic complications. After adjustment, the lead can be safely released and removed, simplifying the procedure. Attached Figure Description
[0023] For ease of explanation, this utility model is described in detail below with reference to the specific embodiments and accompanying drawings.
[0024] Figure 1 This is a schematic diagram of the structure of the film-coated double-layer support of this utility model;
[0025] Figure 2 This is a schematic diagram of the structure of the film-coated double-layer support of this utility model;
[0026] Figure 3 This is a schematic diagram of the structure of the film-coated double-layer support of this utility model;
[0027] Figure 4 This is a schematic diagram of the structure of the coating with adjustable leads of this utility model;
[0028] Figure 5 This is a schematic diagram of the overall structure of the adjustable film-coating bracket of this utility model.
[0029] Figure 6 This is a schematic diagram of the structure of a double-layered, film-coated support structure, in which the first support layer is a woven support and the second support layer is a cut support.
[0030] In the diagram: 1. First support layer; 2. Second support layer; 3. Covering film; 4. Lead wire. Detailed Implementation
[0031] The following are specific embodiments of the present invention described in conjunction with the accompanying drawings, further illustrating the technical solution of the present invention. However, the present invention is not limited to these embodiments. Specific details such as particular configurations and components are provided in the following description merely to aid in a comprehensive understanding of the embodiments of the present invention. Therefore, those skilled in the art should understand that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present invention. Furthermore, for clarity and brevity, descriptions of known functions and structures have been omitted.
[0032] It should be noted that, where there is no conflict, the embodiments and features in the embodiments of this utility model can be combined with each other.
[0033] like Figures 1 to 6 A specific embodiment of a film-coated double-layer stent is shown, including a first stent layer 1 and a second stent layer 2. Both the first stent layer 1 and the second stent layer 2 are self-expanding structures. The first stent layer 1 is sleeved outside the second stent layer 2, and a film 3 is provided between the first stent layer 1 and the second stent layer 2. The length and position of the film 3 are adjustable, and the film 3 is provided with at least one lead wire 4. The lead wire 4 is used to adjust the position of the film 3 in the stent. A release point is provided between the lead wire 4 and the film 3. After the adjustment is completed, the lead wire 4 can be detached from the film 3 and removed.
[0034] Specifically, multiple leads 4 can be emitted from the coating 3, such as... Figure 4 As shown, the lead wire 4 is fixed to the coating 3 by means of bonding, welding, sewing, etc. After the bracket is released, as... Figure 5 As shown, the position of the overlay 3 between the stents can be adjusted by pulling the lead 4 from the proximal end, thereby better covering the lesion site. In this design, there are several radiopaque points at both ends of the overlay 3, which can be clearly marked on X-ray. At the same time, there is a release point between the lead 4 and the overlay 3. After the overlay 3 is adjusted, all leads are released from the overlay 3 and withdrawn from the patient's body from the proximal end.
[0035] Specifically, the length and position of the lining 3 between the first stent layer 1 and the second stent layer 2 are adjustable via the lead wire 4, which greatly reduces the possibility of the lining stent occluding the perforator of the blood vessel and gives clinicians more room for maneuver.
[0036] Specifically, the endothelial graft 3 is fitted with a lead 4 and contrast points (such as X-ray visible markers). The physician can precisely control the coverage area of the endothelial graft 3 by adjusting the lead 4, avoiding compression of perforating vessels and significantly reducing the incidence of postoperative ischemic complications. After adjustment, the lead 4 can be safely detached and removed, simplifying the procedure.
[0037] In other preferred embodiments, the first support layer 1 can be a laser-engraved support or a woven support, and the second support layer 2 can be a laser-engraved support or a woven support.
[0038] Specifically, such as Figure 6 As shown, the first support layer 1 is a woven support, the second support layer 2 is a laser-engraved support, and the coating 3 is located between the two supports.
[0039] Specifically, the braided stent of the first stent layer 1 is made of woven metal wires, which has excellent bending adaptability, making the stent system easier to pass through tortuous intracranial blood vessels, significantly reducing the difficulty of delivery and the risk of vascular injury. The laser-engraved stent of the second stent layer 2 is formed by laser cutting of metal tubes, which has high radial support force and precise structure, ensuring that the stent is stably attached to the wall after deployment and preventing the cladding 3 from collapsing or shifting.
[0040] In other preferred embodiments, the materials of the first stent layer 1 and the second stent layer 2 are selected from any one of nickel-titanium alloy, stainless steel or cobalt-chromium alloy, and the material of the coating 3 is selected from expanded polytetrafluoroethylene, polyurethane or polyethylene terephthalate, to meet different lesion morphologies and clinical needs.
[0041] In other preferred embodiments, the film 3 covers part or all of the surface of the second support layer 2. The film 3 may not be connected to the first support layer 1 and the second support layer 2, but may be fixed by the clamping force between the first support layer 1 and the second support layer 2.
[0042] Specifically, the membrane 3 is sandwiched between the first stent layer 1 and the second stent layer 2. It is fixed by the synergistic clamping force of the double-layer structure, avoiding the problem of internal leakage caused by the membrane 3 not being tightly bonded to the single-layer stent, and significantly improving the blood flow blocking effect.
[0043] Specifically, the double-layer stent structure enhances mechanical stability and reduces the possibility of stent displacement or deformation; the overlay 3 can cover the surface of the second stent layer 2 or the entire surface of the second stent layer 2, taking into account both blood flow blocking and vascular branch protection, and improving long-term treatment effects.
[0044] Specifically, the film 3 does not need to be fixed to the support layer by means of bonding, welding or sewing, which eliminates complicated connection steps, significantly reduces production difficulty and manufacturing cost, and reduces quality problems caused by process errors.
[0045] Specifically, traditional fixation methods (such as welding and sewing) may cause local perforation or weakening of the coating material, while fixation by clamping force alone can maintain the integrity of the coating, reduce the risk of leakage and extend the service life of the device.
[0046] Specifically, the 3-layer endovascular stent can be finely positioned between the two layers of stents. Especially when treating bifurcation vessels or wide-necked aneurysms, doctors can more flexibly adjust the coverage of the endovascular stent to avoid compressing branch vessels and reduce ischemic complications.
[0047] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to the present invention. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.
[0048] In the description of this utility model, it should be understood that the terms "upper" and "lower" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.
[0049] 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 indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this utility model, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.
[0050] Those skilled in the art to which this invention pertains may make various modifications or additions to the specific embodiments described, or adopt similar methods to replace them, without departing from the spirit of this invention or exceeding the scope defined by the appended claims.
Claims
1. A film-coated double-layer scaffold, characterized in that, It includes a first support layer (1) and a second support layer. Both the first support layer (1) and the second support layer (2) are self-expanding structures. The first support layer (1) is sleeved outside the second support layer. A covering film (3) is provided between the first support layer (1) and the second support layer (2). The length and position of the covering film (3) are adjustable. At least one lead wire (4) is provided on the covering film (3). The lead wire (4) is used to adjust the position of the covering film (3) in the support. A release point is provided between the lead wire (4) and the covering film (3). After the adjustment is completed, the lead wire (4) can be detached from the covering film (3) and removed.
2. The film-coated double-layer scaffold according to claim 1, characterized in that, The first support layer (1) can be a laser-engraved support or a woven support, and the second support layer (2) can be a laser-engraved support or a woven support.
3. The film-coated double-layer scaffold according to claim 1, characterized in that, The materials of the first support layer (1) and the second support layer (2) are selected from any one of nickel-titanium alloy, stainless steel or cobalt-chromium alloy.
4. The film-coated double-layer scaffold according to claim 1, characterized in that, The material of the coating (3) is selected from any one of expanded polytetrafluoroethylene, polyurethane or polyethylene terephthalate.
5. A film-coated double-layer scaffold according to claim 1, characterized in that, The coating (3) covers part or all of the surface of the second support layer (2).
6. A film-coated double-layer scaffold according to claim 1, characterized in that, The coating (3) has development points at both ends for marking the position of the coating (3) under X-ray.
7. A film-coated double-layer scaffold according to claim 1, characterized in that, The film (3) is fixed by the clamping force between the first support layer (1) and the second support layer (2).
8. A film-coated double-layer scaffold according to claim 1, characterized in that, The lead wire (4) and the film (3) are fixed by any one of bonding, welding or sewing.