CN116250963A - an airway stent - Google Patents
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- CN116250963A CN116250963A CN202111510933.1A CN202111510933A CN116250963A CN 116250963 A CN116250963 A CN 116250963A CN 202111510933 A CN202111510933 A CN 202111510933A CN 116250963 A CN116250963 A CN 116250963A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/043—Bronchi
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/046—Tracheae
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Abstract
本发明属于医疗器械技术领域,一种气道支架,包括支架本体以及设置在支架本体上的覆膜,其中,所述支架本体包括腰部支架段以及设置在所述腰部支架段端部的密网裸支架段,所述覆膜设置在所述腰部支架段上,所述覆膜包括设置在所述腰部支架段外表面的外膜以及设置在所述腰部支架段内表面的内膜。根据本发明中的气道支架,在保证气道支架能够阻止肿瘤向内生长的同时,保证气道支架两端的黏膜纤毛不受影响,避免分泌物潴留,并且通过双层膜设置,保证了覆膜的结合强度。
The invention belongs to the technical field of medical devices, and relates to an airway stent, which includes a stent body and a covering film arranged on the stent body, wherein the stent body includes a lumbar stent segment and a dense net arranged at the end of the lumbar stent segment In the bare stent segment, the coating is arranged on the lumbar stent segment, and the coating includes an outer membrane arranged on the outer surface of the lumbar stent segment and an inner membrane arranged on the inner surface of the lumbar stent segment. According to the airway stent in the present invention, while ensuring that the airway stent can prevent the inward growth of the tumor, it is ensured that the mucocilia at both ends of the airway stent are not affected, and secretion retention is avoided. membrane binding strength.
Description
技术领域technical field
本发明属于医疗器械技术领域,具体涉及一种气道支架。The invention belongs to the technical field of medical devices, and in particular relates to an airway stent.
背景技术Background technique
气道金属支架的治疗气管,支气管狭窄的重要手段,可迅速重建气道,缓减呼吸困难等症状。根据材质,气道支架可分为金属支架和非金属支架,根据有无覆膜,金属支架又分为覆膜支架和裸支架。The airway metal stent is an important means of treating tracheal and bronchial stenosis, which can quickly rebuild the airway and relieve symptoms such as dyspnea. According to the material, airway stents can be divided into metal stents and non-metallic stents, and metal stents are further divided into covered stents and bare stents according to whether they are covered or not.
早期的气道支架主要采用金属裸支架,金属裸支架主要采用镍钛记忆合金网状支架,金属裸支架具有不易位移,气道分泌物不易潴留的优点。然而,由于金属裸支架的网格空间虚大,不能阻挡肿瘤或肉芽组织沿网眼生长,恶性肿瘤易生长进入支架内腔而导致气道再狭。故,金属裸支架仅能够短期放置以缓解气道梗阻,不宜放置时间太久。The early airway stents mainly used bare metal stents, and the bare metal stents mainly used nickel-titanium memory alloy mesh stents. However, because the mesh space of the bare metal stent is large, it cannot prevent tumor or granulation tissue from growing along the mesh, and malignant tumors are likely to grow into the lumen of the stent and cause airway restenosis. Therefore, bare metal stents can only be placed for a short period of time to relieve airway obstruction, and should not be placed for too long.
基于上述问题,现有技术中出现了覆膜支架,覆膜支架在裸支架的基础上,增加了一层覆膜,通过覆膜阻止肿瘤生长进入支架内。由于覆膜对气道内壁的刺激少,因此可以有效的减少肉芽组织增生。但是,覆膜支架阻止了气道支架粘膜纤毛的作用,难以清洁气道内分泌物,造成气道两端分泌物潴留,导致病人出现咳嗽及肺炎等并发症。Based on the above problems, a covered stent has appeared in the prior art. A covered stent is added with a layer of film on the basis of the bare stent, and the film is used to prevent tumor growth from entering the stent. Since the film has less stimulation to the inner wall of the airway, it can effectively reduce the hyperplasia of granulation tissue. However, the covered stent prevents the mucociliary function of the airway stent, making it difficult to clean the secretions in the airway, resulting in the retention of secretions at both ends of the airway, leading to complications such as cough and pneumonia in patients.
因此,需要一种新的技术手段在不使气道分泌物在气道支架表面潴留的同时,减小气道支架对气道内壁的刺激,从而减少肉芽组织的增生。Therefore, there is a need for a new technical means to reduce the stimulation of the airway stent to the inner wall of the airway without causing the airway secretions to remain on the surface of the airway stent, thereby reducing the hyperplasia of granulation tissue.
发明内容Contents of the invention
本发明的目的是至少解决现有的金属覆膜支架容易刺激气道内壁,从而增加肉芽组织增生的问题。The purpose of the present invention is to at least solve the problem that the existing metal-covered stent is easy to irritate the inner wall of the airway, thus increasing the hyperplasia of granulation tissue.
本发明提出一种气道支架,包括支架本体以及设置在支架本体上的覆膜,其中,所述支架本体包括腰部支架段以及设置在所述腰部支架段端部的密网裸支架段,所述覆膜设置在所述腰部支架段上,所述覆膜包括设置在所述腰部支架段外表面的外膜以及设置在所述腰部支架段内表面的内膜。The present invention proposes an airway stent, which includes a stent body and a covering film arranged on the stent body, wherein the stent body includes a lumbar stent segment and a dense mesh bare stent segment arranged at the end of the lumbar stent segment. The covering film is arranged on the lumbar support section, and the covering film includes an outer film arranged on the outer surface of the lumbar support section and an inner film arranged on the inner surface of the lumbar support section.
根据本发明中的气道支架,在腰部支架段上设置覆膜,通过覆膜减少腰部支架段给气道内壁造成的刺激,并通过双层膜的设置,提高了覆膜的结合强度,进一步阻止肿瘤向支架内生长;并且在腰部支架段的两端设置密网裸支架段,保证气道支架与气道内壁之间的锚定力,同时保证了气道内壁上黏膜纤毛不受影响,气道支架两端也不会有分泌物潴留;因此,通过使用本发明的气道支架,能够在不使气道分泌物在气道支架表面潴留的同时,减小气道支架对气道内壁的刺激,从而减少肉芽组织的增生,避免气道再次狭窄的发生。According to the airway stent in the present invention, a coating is set on the lumbar stent section, and the irritation caused by the lumbar stent section to the inner wall of the airway is reduced through the coating, and the bonding strength of the coating is improved through the setting of the double-layer film, further Prevent the tumor from growing into the stent; and set a dense mesh bare stent section at both ends of the lumbar stent section to ensure the anchoring force between the airway stent and the inner wall of the airway, and at the same time ensure that the mucocilia on the inner wall of the airway is not affected. There will be no secretion retention at both ends of the airway stent; therefore, by using the airway stent of the present invention, the impact of the airway stent on the inner wall of the airway can be reduced while the airway secretions are not retained on the surface of the airway stent. Stimulation, thereby reducing the hyperplasia of granulation tissue, to avoid the occurrence of airway narrowing again.
另外,根据本发明的气道支架,还可具有如下附加的技术特征:In addition, the airway stent according to the present invention may also have the following additional technical features:
在本发明的一些实施例中,其中,所述内膜与所述外膜通过所述腰部支架段的网孔进行结合固定。In some embodiments of the present invention, wherein, the inner membrane and the outer membrane are combined and fixed through the mesh of the lumbar support segment.
在本发明的一些实施例中,其中,所述支架本体内还设置有覆盖所述密网裸支架段内表面的延伸膜。In some embodiments of the present invention, an extension film covering the inner surface of the dense mesh bare stent segment is further arranged in the stent body.
在本发明的一些实施例中,其中,所述密网裸支架段的网孔密度大于所述腰部支架段的网孔密度,所述密网裸支架段为单层密集编织网结构或多层编织网结构。In some embodiments of the present invention, wherein, the mesh density of the dense mesh bare stent segment is greater than that of the waist stent segment, and the dense mesh bare stent segment is a single-layer densely woven mesh structure or a multi-layer Woven mesh construction.
在本发明的一些实施例中,其中,所述密网裸支架段包括内层支撑网以及外层支撑网,所述内层支撑网的一端连接于所述腰部支架段,所述内层支撑网的另一端连接于所述外层支撑网;或者所述外层支撑网的一端连接于所述腰部支架段,所述外层支撑网的另一端连接于所述内层支撑网。In some embodiments of the present invention, wherein, the dense mesh bare stent segment includes an inner support net and an outer support net, one end of the inner support net is connected to the waist support segment, and the inner support net The other end of the net is connected to the outer support net; or one end of the outer support net is connected to the waist support segment, and the other end of the outer support net is connected to the inner support net.
在本发明的一些实施例中,其中,所述内层支撑网与所述外层支撑网之间设置有夹层膜。In some embodiments of the present invention, an interlayer film is arranged between the inner support net and the outer support net.
在本发明的一些实施例中,其中,所述内层支撑网与所述腰部支架段一体成型,所述内层支撑网的端部外翻并折回后形成所述外层支撑网,所述内层支撑网与所述外层支撑网之间通过翻折端部连接。In some embodiments of the present invention, wherein, the inner support net is integrally formed with the lumbar support section, and the end of the inner support net is turned outward and folded back to form the outer support net. The inner support net is connected with the outer support net through folded ends.
在本发明的一些实施例中,其中,所述翻折端部相对于所述外层支撑网朝向背离所述支架本体的方向凸起,所述外层支撑网上设置有至少一个凸点支撑部,所述凸点支撑部与所述翻折端部的形状相同或不同。In some embodiments of the present invention, wherein, the folded end protrudes in a direction away from the stent body relative to the outer support net, and at least one convex point support portion is provided on the outer support net , the shape of the bump support portion is the same as or different from that of the folded end portion.
在本发明的一些实施例中,其中,所述腰部支架段上设置有用于增加所述覆膜与所述腰部支架段连接强度的缝合线。In some embodiments of the present invention, the lumbar support segment is provided with sutures for increasing the connection strength between the membrane and the lumbar support segment.
在本发明的一些实施例中,其中,所述支架本体一端的所述密网裸支架段上设置有回收线,所述回收线沿所述密网裸支架段的边缘穿设。In some embodiments of the present invention, a recovery line is provided on the dense mesh bare stent segment at one end of the stent body, and the recovery line passes along the edge of the dense mesh bare stent segment.
附图说明Description of drawings
图1为本发明的实施例一中气道支架的整体结构示意图;Figure 1 is a schematic diagram of the overall structure of the airway stent in Embodiment 1 of the present invention;
图2为本发明的实施例一中支架本体的结构示意图;2 is a schematic structural view of the stent body in Embodiment 1 of the present invention;
图3为本发明的实施例一中支架主体的剖视图;Fig. 3 is a cross-sectional view of the stent main body in Embodiment 1 of the present invention;
图4为本发明的实施例一中气道支架植入气道后的示意图;Fig. 4 is a schematic diagram of the airway stent implanted in the airway in Embodiment 1 of the present invention;
图5为本发明的实施例一中气道内壁生长肉芽时的示意图;Figure 5 is a schematic diagram of the growth of granulation on the inner wall of the airway in Example 1 of the present invention;
图6为本发明的实施例一中气道本体的翻折端部的结构示意图;Fig. 6 is a schematic structural view of the folded end of the airway body in Embodiment 1 of the present invention;
图7为本发明的实施例一中气道本体的翻折端部的剖视图;Fig. 7 is a cross-sectional view of the folded end of the airway body in Embodiment 1 of the present invention;
图8为本发明的实施例一中翻折端部的第二实施方案的示意图;Fig. 8 is a schematic diagram of a second embodiment of the folded end in Embodiment 1 of the present invention;
图9为本发明的实施例一中翻折端部的第三实施方案的示意图;Fig. 9 is a schematic diagram of the third embodiment of the folded end in Embodiment 1 of the present invention;
图10为本发明的实施例一中覆膜的结构示意图;Fig. 10 is a schematic structural view of the covering film in Embodiment 1 of the present invention;
图11为本发明的实施例一中外膜结构的示意图;11 is a schematic diagram of the outer membrane structure in Embodiment 1 of the present invention;
图12为本发明的实施例一中外膜与内膜结构的示意图;Fig. 12 is a schematic diagram of the outer membrane and inner membrane structure in Embodiment 1 of the present invention;
图13为本发明的实施例二中凸点支撑部的剖视图;Fig. 13 is a cross-sectional view of the bump support part in the second embodiment of the present invention;
图14为本发明的实施例二中凸点支撑部的另一实施方案的示意图;Fig. 14 is a schematic diagram of another embodiment of the bump support part in the second embodiment of the present invention;
图15为本发明的实施例三中延伸膜的结构示意图;Figure 15 is a schematic structural view of the stretched film in Example 3 of the present invention;
图16为本发明的实施例四中夹层膜的结构示意图;Fig. 16 is a schematic structural view of an interlayer film in Embodiment 4 of the present invention;
图17为本发明的实施例四中夹层膜与延伸膜的结构示意图;Fig. 17 is a schematic structural view of the interlayer film and the stretched film in Embodiment 4 of the present invention;
图18为本发明的实施例五中缝合线的结构示意图;Figure 18 is a schematic structural view of the suture in Embodiment 5 of the present invention;
图19为本发明的实施例五中缝合线的剖面结构示意图;Fig. 19 is a schematic cross-sectional structure diagram of a suture in Embodiment 5 of the present invention;
图20为本发明的实施例五中缝合线的第二实施方式的示意图;Fig. 20 is a schematic diagram of the second embodiment of the suture in Example 5 of the present invention;
图21为本发明的实施例五中缝合线的第三实施方式的示意图;Fig. 21 is a schematic diagram of the third embodiment of the suture in the fifth embodiment of the present invention;
图22为本发明的实施例五中缝合线的第四实施方式的示意图;Fig. 22 is a schematic diagram of the fourth embodiment of the suture in the fifth embodiment of the present invention;
图23为本发明的实施例六中回收线的结构示意图;Figure 23 is a schematic structural view of the recovery line in Embodiment 6 of the present invention;
图24为本发明的实施例六中回收线的剖面结构示意图;Fig. 24 is a schematic cross-sectional structure diagram of the recycling line in Embodiment 6 of the present invention;
图25为本发明的实施例六中回收线的另一实施方式的示意图;Fig. 25 is a schematic diagram of another embodiment of the recycling line in Embodiment 6 of the present invention;
图26为本发明的实施例七中气道支架的整体结构示意图;Fig. 26 is a schematic diagram of the overall structure of the airway stent in Embodiment 7 of the present invention;
图27为本发明的实施例七中气道支架植入气道后的示意图;Fig. 27 is a schematic diagram of the airway stent implanted in the airway in Embodiment 7 of the present invention;
图28为本发明的实施例七中支架本体的结构示意图;Fig. 28 is a schematic structural view of the stent body in Embodiment 7 of the present invention;
图29为本发明的实施例七中支架本体的连接部的结构示意图;Fig. 29 is a schematic structural view of the connection part of the stent body in Embodiment 7 of the present invention;
图30为本发明的实施例七中支架本体的连接部的另一实施方式的结构示意图;Fig. 30 is a schematic structural view of another embodiment of the connection part of the stent body in Embodiment 7 of the present invention;
图31为本发明的实施例七中覆膜的结构示意图;FIG. 31 is a schematic structural view of the coating in Embodiment 7 of the present invention;
图32为本发明的实施例八中气道支架的整体结构示意图;Fig. 32 is a schematic diagram of the overall structure of the airway stent in Embodiment 8 of the present invention;
图33为本发明的实施例八中支架本体的整体结构示意图;Fig. 33 is a schematic diagram of the overall structure of the stent body in Embodiment 8 of the present invention;
图34为本发明的实施例八中第二编织丝的结构示意图;Fig. 34 is a schematic structural view of the second braided yarn in Embodiment 8 of the present invention;
图35为本发明的实施例八中第二编织丝的另一实施方式的结构示意图;Fig. 35 is a schematic structural view of another embodiment of the second braided yarn in Embodiment 8 of the present invention;
图36为本发明的实施例八中气道支架的另一实施方式的整体结构示意图;Fig. 36 is a schematic diagram of the overall structure of another embodiment of the airway stent in Embodiment 8 of the present invention;
图37为本发明的实施例八中主编织丝与副编织丝的连接结构示意图;Fig. 37 is a schematic diagram of the connection structure of the main braiding filament and the secondary braiding filament in Embodiment 8 of the present invention;
图38为本发明的实施例九中支架主体的部分结构示意图;Fig. 38 is a partial structural schematic diagram of the main body of the stent in Embodiment 9 of the present invention;
图39为本发明的实施例九中第二编织丝与第三编织丝的结构示意图;Fig. 39 is a schematic structural view of the second braided wire and the third braided wire in Embodiment 9 of the present invention;
图40为本发明的实施例九中第二编织丝与第三编织丝的另一实施方式的结构示意图。Fig. 40 is a schematic structural view of another embodiment of the second braided yarn and the third braided yarn in the ninth embodiment of the present invention.
附图中各标号表示如下:In the accompanying drawings, each label represents as follows:
10、支架本体;11、网孔;20、覆膜;21、内膜;22、外膜;23、夹层膜;24、延伸膜;25、连接部;30、腰部支架段;301、第二编织丝;302、第三编织丝;40、密网裸支架段;401、第一密网段;402、第二密网段;403、第一编织丝;404、主编织丝;405、副编织丝;41、内层支撑网;42、外层支撑网;43、翻折端部;44、凸点支撑部;45、网丝集中点;50、缝合线;51、缝合圈;60、回收线;61、连接线;62、操作线;70、气道内壁;80、肿瘤;90、肉芽组织。10. Stent body; 11. Mesh; 20. Covering film; 21. Intima; 22. Outer film; 23. Interlayer film; 24. Extended film; Braided silk; 302, the third braided silk; 40, dense mesh bare support section; 401, the first dense mesh section; 402, the second dense mesh section; 403, the first braided silk; 404, main braided silk; 405, secondary Braided silk; 41, inner support net; 42, outer support net; 43, folded end; 44, bump support; 45, mesh concentration point; 50, suture line; 51, suture circle; 60, Recovery line; 61, connection line; 62, operation line; 70, inner wall of airway; 80, tumor; 90, granulation tissue.
具体实施方式Detailed ways
下面将参照附图更详细地描述本发明的示例性实施方式。虽然附图中显示了本发明的示例性实施方式,然而应当理解,可以以各种形式实现本发明而不应被这里阐述的实施方式所限制。相反,提供这些实施方式是为了能够更透彻地理解本发明,并且能够将本发明的范围完整的传达给本领域的技术人员。Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the drawings, it should be understood that the invention may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided for more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.
应理解的是,文中使用的术语仅出于描述特定示例实施方式的目的,而无意于进行限制。除非上下文另外明确地指出,否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。It should be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may also be meant to include the plural forms unless the context clearly dictates otherwise.
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段,但是,这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、部件、区域、层或部段与另一区域、层或部段区分开。Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be referred to as These terms are limited. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section.
为了便于描述,可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系,这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。For the convenience of description, spatial relative terms may be used herein to describe the relationship of one element or feature as shown in the figures with respect to another element or feature, such as "inner", "outer", "inner". ", "Outside", "Below", "Below", "Above", "Above", etc. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures.
为了便于描述,以下描述使用术语“近端”和“远端”,其中“近端”是指的是离操作者近的一端,“远端”是指远离操作者的一端,短语“轴向方向”,本专利里应当被理解成表示介入器械被推进和推出的方向,与“轴向方向”相垂直的方向定义为“径向方向”。For ease of description, the following description uses the terms "proximal" and "distal", where "proximal" refers to the end near the operator, "distal" refers to the end away from the operator, and the phrase "axial Direction” in this patent should be understood as the direction in which the interventional device is pushed and pushed out, and the direction perpendicular to the “axial direction” is defined as the “radial direction”.
实施例一,一种气道支架,如图1与图2所示,包括支架本体10以及设置在支架本体10上的覆膜20。其中,支架本体10包括腰部支架段30以及设置在腰部支架段30一端的密网裸支架段40。支架本体10通过编织丝编织成型,相邻编织丝之间的间隙围合形成网孔11,其中,密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度,且覆膜20设置在腰部支架段30上。首先,本申请在腰部支架段30上设置覆膜20,通过覆膜20减少腰部支架段30给气道内壁造成的刺激,而且能够阻止肿瘤向气道支架方向生长。Embodiment 1, an airway stent, as shown in FIG. 1 and FIG. 2 , includes a
在本实施例中,结合图5所示,密网裸支架段40为外侧无膜结构设置的支架段,网孔11的密度为单位面积上网孔11的个数。即,本申请的腰部支架段30上设置有覆膜20,腰部支架段30的至少一端设置有密网裸支架段30,从而减少支架本体10对气道内壁70的刺激。由于密网裸支架段40的外侧无膜结构设置,从而不影响气道内壁70纤毛的功能,保证了气道分泌物不会在气道本体10上潴留。由于气道本体10上设置了一段无膜结构设置的密网裸支架段40,而裸露的支架容易对气道内壁70造成刺激,因此将密网裸支架段40的网孔11的密度设置的更大,因此能够增大密网裸支架段40与气道内壁70之间的接触面积,减小密网裸支架段40整体对气道内壁70的压强,从而有效的减小支架本体10端部对气道内壁70的刺激,减少肉芽组织90的生长。In this embodiment, as shown in FIG. 5 , the dense mesh
本申请中,腰部支架段30的至少一端设置有密网裸支架段40,或者腰部支架段30的两端均设置有密网裸支架段40。具体的,在腰部支架段30的两端设置密网裸支架段40通过上述技术方案,利用气道本体10两端裸露的密网裸支架段40保证支架本体10与气道内壁之间锚定力,由于腰部支架段30的两端采用了密网裸支架段40的设计,密网裸支架段40存在间隙,支架本体10两端不会有分泌物潴留。In the present application, at least one end of the
因此,通过使用本申请的气道支架,不仅能够保证锚定力,还能够在不使气道分泌物在气道支架表面潴留的同时,减小支架本体10对气道内壁的刺激,从而减少肉芽组织的增生,有效的避免了气道再次狭窄的发生。Therefore, by using the airway stent of the present application, not only the anchoring force can be ensured, but also the irritation of the
本申请的密网裸支架段40可以采用错位设置的多层的编织网结构,也可以采用单层的编织网密集编织的方式,当采用单层的编织网密集编织时,可以采用一种编织丝进行密集编织,也可以采用二种或多种不同的编织丝进行混合编织。The dense mesh
在本实施例中,如图3所示,密网裸支架段40采用双层编织网结构。密网裸支架段40的双层编织网结构包括内层支撑网41以及外层支撑网42,内层支撑网41的一端连接于腰部支架段30,内层支撑网41的另一端连接于外层支撑网42。在其他实施例中,外层支撑网42的一端连接于腰部支撑段30,外层支撑网42的另一端连接于内层支撑网41。In this embodiment, as shown in FIG. 3 , the dense mesh
在本实施例中,内层支撑网41的一端连接于腰部支架段30,内层支撑网41的另一端连接于外层支撑网42,且内层支撑网41与外层支撑网42之间通过翻折端部43连接。In this embodiment, one end of the
如图4与图5所示,随着植入时间的增长,现有气道支架的两端部容易生长肉芽。据文献表明,支架本体10两端的肉芽组织90主要由于支架本体10两端的尖锐材料刺激造成。而本申请通过外翻并折回后形成的密网裸支架段40的端部不存在传统裸支架的尖锐的部分,即内层支撑网41与外层支撑网42之间通过翻折端部43连接。As shown in FIGS. 4 and 5 , as the implantation time increases, granulation tends to grow at both ends of the existing airway stent. According to the literature, the
一方面,由于翻折端部43是通过翻折形成的,因此具有平滑的表面,而平滑的表面对气道内壁70的刺激相比传统裸支架尖锐的端部小很多,故支架本体10的两端不容易因为刺激导致肉芽组织90生长。On the one hand, since the turned-over
另一方面,由于支架本体10两端为外翻对折的结构,从而形成密网编织的端部,使得支架本体10两端的端部与气道内壁70接触面积增大,减少了气道内壁70单位面积收到的压力,使气道内壁70刺激变小,进一步减少肉芽组织90的增生。On the other hand, since the two ends of the
另外,即使支架本体10两端产生了肉芽增生的现象,本实施例的气道支架也可以减缓肉芽往支架内部生长的时间。当肉芽组织90增生时,首先接触位于外侧的外层支撑网42,如果肉芽组织90生长越过外层支撑网42,会再次接触到内侧的内层支撑网41,内层支撑网41作为第二阻挡部分,再次阻挡肉芽组织90向支架内部生长。外层支撑网42和内层支撑网41作为双层阻挡作用,可以增加肉芽组织90生长到气道支架内腔的时间,为医生和患者争取更多的解决时间。In addition, even if granulation hyperplasia occurs at both ends of the
具体成型时,内层支撑网41与腰部支架段30一体成型,内层支撑网41的端部外翻并折回后形成外层支撑网42。During specific molding, the
在其他实施例中,当外层支撑网42的一端连接于腰部支撑段30,外层支撑网42的另一端连接于内层支撑网41时,外层支撑网42的端部可以内翻并折回后形成内层支撑网41。即,不论密网裸支架段40是通过外翻还是内翻形成,只要能够形成双层的编织网结构,以使密网裸支架段40的网孔11的密度大于腰部支撑段30的网孔的密度即可。In other embodiments, when one end of the
在本实施例中,如图6与图7所示,两个分别设置在腰部支架段30两端的密网裸支架段40包括设置在腰部支架段30一端的第一密网段401,以及设置在腰部支架段30另一端的第二密网段402,支架本体10通过一根或者多根编织丝编织成一个网管结构后,网管结构的两端外翻后分别折成第一密网段401和第二密网段402。第一密网段401的结构与第二密网段402的结构可以相同也可以不同,医生可以具体根据病人的实际情况进行选择。例如,第一密网段401与第二密网段402的长度不同,或者第一密网段401与第二密网段402的翻折端部43结构不同等。In this embodiment, as shown in FIG. 6 and FIG. 7 , two dense net
其中,翻折端部43相对于外层支撑网42朝向背离支架本体10的方向凸起,即,支架本体10两端的翻折端部43的外径大于腰部支架段30的外径。Wherein, the folded ends 43 protrude toward the direction away from the
翻折端部43结构为圆弧形结构,例如圆形或球形结构。即内层支撑网41与外层支撑网42的对折处采用圆弧形过渡,使得翻折端部43与气道内壁70之间的接触面平滑过渡,减小支架本体10对气道内壁70的刺激。The folded
在支架本体10植入后,翻折端部43的弧形面与气道内壁70接触,用于保持支架本体10固定,且同时保证了支架本体10两端部分气道黏膜纤毛的清洁作用,减少气道分泌物的潴留,还能够组织肉芽组织90增生。After the
气道支架的主要作用是,当支架植入恶性气道病变造成气道狭窄的部位后,气道本体10会压缩肿瘤80,以恢复气道中央通气。此时,气道本体10固定在气道内的主要机理是,位于支架本体10中部的腰部支架段30径向扩张力与肿瘤80相互作用,而使支架本体10无移位。The main function of the airway stent is that when the stent is implanted in the place where the airway is narrowed by malignant airway lesions, the
一般情况下,对于恶性肿瘤80在植入支架后,通常会进行放射化疗,放射化疗后肿瘤80会逐渐缩小,随着肿瘤80的缩小,腰部支架段30与肿瘤80之间的作用力会相对减小。当出现上述情况时,现有技术的气道支架容易产生位移。Generally speaking, after the
而本申请由于翻折端部43相对于外层支撑网42朝向背离支架本体10的方向凸起,从而翻折端部43的外径大于腰部支架段30的外径。在肿瘤80缩小以后,虽然腰部支架段30与肿瘤80之间的作用力减小,但是翻折端部43与气道内壁7的作用力会相对增大,从而维持了支架本体10与气道之间的整体作用力,因此本申请的气道支架不容易产生位移。However, in this application, the outer diameter of the folded
在其他实施例中,结合图8所示,翻折端部43还可以为方形形状。上述设置的好处在于,能够增加翻折端部43与气道内壁70之间的接触面积,增加支架本体10与气道内壁70的锚定力。In other embodiments, as shown in FIG. 8 , the folded
在其他实施例中,如图9所示,当第一密网段401与第二密网段402的翻折端部43结构不同时,第一密网段401的翻折端部43为方形,第二密网段402的翻折端部43为圆弧形。上述设置的好处在于,医生可以根据病人的实际情况,选择不同形状的翻折端部43,以适应不同病情的患者。In other embodiments, as shown in FIG. 9, when the structures of the folded
进一步的,结合图10至图12所示,覆膜20包括设置在腰部支架段30外表面的外膜22。为了进一步阻止气道内的恶性肿瘤80向支架本体10内生长,造成气道内壁70再狭窄或支架本体10不易取出,本实施例在腰部支架段30的外表面覆有一层生物相容性高分子覆膜20,用于进一步阻止恶性肿瘤80向支架本体10内生长。Further, as shown in FIG. 10 to FIG. 12 , the covering
其中,覆膜20的材质可选用PET、PTFE、ePTFE、硅胶、聚氨酯等,覆膜20的厚度根据支架本体10编织丝的大小和支架本体10的内外径而调整,本申请不做限制。Among them, the material of the
为了增强覆膜20与支架本体10之间的结合强度,并进一步阻止肿瘤向内生长,本申请的覆膜20还包括设置在腰部支架段30的内表面的内膜21,由于支架本体10存在网孔11,因此内膜21和外膜22可以通过腰部支架段30的网孔11进行结合固定。其中,内膜21和外膜22可以通过热熔固定,也可以通过粘接固定,内膜21与外膜22的材质可以选择相同或者不同。In order to enhance the bonding strength between the covering
因此,本实施例在腰部支架段30的两端设置密网裸支架段40,且密网裸支架段40的网孔11的密度相较于腰部支架段30的网孔11的密度更大。同时,本发明的气道支架在保证密网裸支架段40与气道内壁70之间锚定力的同时,增大了密网裸支架段40与气道内壁70之间的接触面积,减少了气道内壁70单位面积所受到的压强,使得气道内壁70刺激变小,并且,由于腰部支架段30的两端采用了密网裸支架段40的设计,支架本体10两端也不会有分泌物潴留。Therefore, in this embodiment, dense mesh
综上,通过使用本发明的气道支架,能够在不使气道分泌物在气道支架表面潴留的同时,减小气道支架对气道内壁的刺激,从而减少肉芽组织的增生,避免气道再次狭窄的发生。To sum up, by using the airway stent of the present invention, it is possible to reduce the stimulation of the airway stent to the inner wall of the airway without causing the retention of airway secretions on the surface of the airway stent, thereby reducing the hyperplasia of granulation tissue and avoiding The passage narrows again.
实施例二,本申请的实施例二提供一种气道支架,如图1至图3所示,支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40,密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度,覆膜20设置在腰部支架段30上。密网裸支架段40为双层编织网结构,双层编织网结构的密网裸支架段40包括内层支撑网41以及外层支撑网42。内层支撑网41的一端连接于腰部支架段30,且内层支撑网41与腰部支架段30一体成型,内层支撑网41的另一端连接于外层支撑网42。结合图6,内层支撑网41的端部外翻并折回后形成外层支撑网42,内层支撑网41与外层支撑网42之间通过翻折端部43连接,翻折端部43相对于外层支撑网42朝向背离支架本体10的方向凸起。Embodiment 2. Embodiment 2 of the present application provides an airway support. As shown in FIGS.
如图13与图14所示,本实施例在外层支撑网42上还设置有至少一个凸点支撑部44,所述凸点支撑部44与所述翻折端部43的形状相同或不同。其中,凸点支撑部44与外层支撑网42一体成型,凸点支撑部44由外层支撑网42朝向背离支架本体10的方向凸起形成。As shown in FIG. 13 and FIG. 14 , in this embodiment, at least one
凸点支撑部44可以为一个或多个,当凸点支撑部44为多个时,多个凸点支撑部44的形状可以相同或不同。凸点支撑部44的形状优选为圆弧形,也可以根据实际需要设置为方形等其他形状。There can be one or more
本实施例通过在外层支撑网42上增设凸点支撑部44,能够加强支架本体10与气道内壁70之间的锚定力,还能够减少翻折端部43和每个凸点支撑部44与气道内壁70之间的压强,降低支架本体10对气道内壁70的刺激,避免肉芽组织90的增生。In this embodiment, the anchoring force between the
在其他实施例中,两个分别设置在腰部支架段30两端的密网裸支架段40包括设置在腰部支架段30一端的第一密网段401,以及设置在腰部支架段30另一端的第二密网段402。In other embodiments, the two dense mesh
当第一密网段401与第二密网段402的凸点支撑部44结构不同时,第一密网段401的凸点支撑部44可以均为圆弧形或其中一个凸点支撑部44为圆弧形,第二密网段402的凸点支撑部44可以均为方形或其中一个凸点支撑部44为方形。上述设置的好处在于,医生可以根据病人的实际情况,选择不同形状的凸点支撑部44,以适应不同病情的患者。When the structures of the
综上,本实施例通过增设凸点支撑部44,从而加强支架本体10与气道内壁70之间的锚定力,减少支架本体10与气道内壁70之间整体的压强,降低支架本体10对气道内壁70的刺激,有效避免肉芽组织90增生。To sum up, in this embodiment, the anchoring force between the
实施例三,本申请的实施例三提供一种气道支架,如图1至图3所示,支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40,密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度,覆膜20设置在腰部支架段30上。如图5所示,密网裸支架段40为双层编织网结构,双层编织网结构的密网裸支架段40包括内层支撑网41以及外层支撑网42。内层支撑网41的一端连接于腰部支架段30,内层支撑网41的另一端连接于外层支撑网42。Embodiment 3. Embodiment 3 of the present application provides an airway support. As shown in FIGS.
其中,如图12所示,覆膜20包括设置在腰部支架段30外表面的外膜22以及设置在所述腰部支架段30内表面的内膜21,内膜21与外膜22通过腰部支架段30的网孔11进行结合固定,例如热熔结合的方式。Wherein, as shown in FIG. 12 , the covering
如图15所示,本实施例为了进一步阻止肿瘤80向内生长,也阻止支架本体10两端肉芽组织90的增生,支架本体10内还设置有覆盖密网裸支架段40内表面的延伸膜24,延伸膜24与内膜21一体设置,从而覆盖支架本体10的全内表面。As shown in Figure 15, in order to further prevent the inward growth of
延伸膜24的材质可选用PET、PTFE、ePTFE、硅胶、聚氨酯等,延伸膜24的厚度根据实际需要设置。当延伸膜24与内膜21一体设置时,延伸膜24的材质与内膜21相同。The material of the
在其他实施方案中,延伸膜24与内膜21还可以与内膜21分别设置,此时,延伸膜24与内膜21的材质可以相同也可以不同。In other embodiments, the
由于在密网裸支架段40内表面也增设了延伸膜24,因此本实施例的覆膜20可以覆盖支架本体10的全内表面,不仅可以阻止肿瘤80向内生长,还可以阻止支架本体10两端的肉芽组织90向内生长。同时,支架本体10外翻部分,即外层支撑网42保持裸支架状态,外层支撑网42的外表面无覆膜20,从而使气道中黏膜纤毛的清洁能力保持不变,能够有效的清除气道内壁70分泌物的潴留。Since the
在其他实施例中,外膜22还可以部分的覆盖密网裸支架段40,从而提高密网裸支架段40与腰部支架段30之间的连接力。In other embodiments, the
综上,本实施例通过在支架本体10内侧设置覆盖密网裸支架段40内表面的延伸膜24,从而在阻止肿瘤80向内生长的同时,阻止支架本体10两端肉芽组织90的增生。To sum up, in this embodiment, the
实施例四,本申请的实施例四提供一种气道支架,如图1至图3所示,支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40,密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度,覆膜20设置在腰部支架段30上。如图5所示,密网裸支架段40为双层编织网结构,双层编织网结构的密网裸支架段40包括内层支撑网41以及外层支撑网42。内层支撑网41的一端连接于腰部支架段30,内层支撑网41的另一端连接于外层支撑网42。Embodiment 4. Embodiment 4 of the present application provides an airway support. As shown in FIGS.
其中,如图12所示,覆膜20包括设置在腰部支架段30外表面的外膜22以及设置在所述腰部支架段30内表面的内膜21,内膜21与外膜22通过腰部支架段30的网孔11进行结合固定,例如热熔结合的方式。Wherein, as shown in FIG. 12 , the covering
如图16所示,本实施例为了进一步阻止肿瘤80向内生长和肉芽组织90的增生,在内层支撑网41与外层支撑网42之间设置有夹层膜23。通过夹层膜23的设置,不仅能够阻止肿瘤80向内生长和肉芽组织90的增生,还能够保持气道内壁70中黏膜纤毛的清洁能力。As shown in FIG. 16 , in this embodiment, in order to further prevent the inward growth of the
具体的,支架本体10内侧表面覆有内膜21,支架本体10外侧表面覆有外膜22,支架本体10两端外翻折回的外层支撑网42与内层支撑网41之间的夹层部分设置覆有夹层膜23,夹层膜23能够紧贴内层支撑网41。Specifically, the inner surface of the
夹层膜23的材质可选用PET、PTFE、ePTFE、硅胶、聚氨酯等,夹层膜23的厚度根据实际需要设置。The material of the
在其他实施方案中,如图17所示,为了使夹层膜23的熔接性更好,支架本体10内还设置有覆盖密网裸支架段40内表面的延伸膜24,延伸膜24与内膜21一体设置,从而覆盖支架本体10的全内表面。夹层膜23与延伸膜24之间通过内层支撑网41的网孔11进行结合固定,其中,夹层膜23与延伸膜24之间可以通过热熔固定,也可以通过粘接固定。In other embodiments, as shown in FIG. 17, in order to make the
综上,本实施例通过在内层支撑网41与外层支撑网42之间增设夹层膜23,从而在不影响气道内壁70的黏膜纤毛的清洁能力的同时,阻止肿瘤80向内生长和肉芽组织90的增生。To sum up, in this embodiment, the
实施例五,本申请的实施例五提供一种气道支架,如图1至图3所示,支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40,密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度,覆膜20设置在腰部支架段30上。密网裸支架段40为双层编织网结构,双层编织网结构的密网裸支架段40包括内层支撑网41以及外层支撑网42。内层支撑网41的一端连接于腰部支架段30,内层支撑网41的另一端连接于外层支撑网42。Embodiment 5. Embodiment 5 of the present application provides an airway support. As shown in FIGS.
其中,如图12所示,覆膜20包括设置在腰部支架段30外表面的外膜22以及设置在所述腰部支架段30内表面的内膜21,内膜21与外膜22通过腰部支架段30的网孔11进行结合固定,例如热熔结合的方式。Wherein, as shown in FIG. 12 , the covering
如图18与图19所示,本实施例为了进一步提高覆膜20与支架本体10的结合强度,防止覆膜20与支架分离,在腰部支架段30上设置了用于增加覆膜20与所述腰部支架段30连接强度的缝合线50。As shown in Figure 18 and Figure 19, in order to further improve the bonding strength between the
在其他实施例中,覆膜20还可以部分地覆盖在密网支架段40上,且缝合线50缝合在密网裸支架段40上。In other embodiments, the covering
在本实施例中,缝合线50穿过腰部支架段30或密网裸支架段40的网孔11,并绕支架本体10外缘和覆膜20的边缘内外穿设,形成波浪形的线型结构,然后往复缠绕拉紧,使得覆膜20紧紧贴在支架本体10的编织丝上。在本实施方案中,缝合线50绕支架本体10外缘至少一周,从而将覆膜20的一整圈完全缝合固定在支架本体10上。In this embodiment, the
缝合线50可以每隔一个网孔11穿设一次,也可以每隔多个网孔11穿设一次,如图20所示,为缝合线50每隔四个网孔11穿设一次。缝合线50穿过覆膜20时会产生穿刺孔,如果穿刺孔过多,会导致覆膜20的强度受到影响。因此,缝合线50穿设的间隔可以根据缝合线50的材质等实际情况进行选择,本实施例不作限定。The
由于穿刺孔过多会导致覆膜20的强度受到影响,因此缝合线50在从内向外、从外向内穿过同一个网孔11时,共用一个穿刺孔,从而减少穿刺孔的数量。Since too many puncture holes will affect the strength of the covering
其中,缝合线50优选PET、PTFE、ePTFE等材质,缝合线50的外径根据支架本体10编织丝的丝径和覆膜20的厚度确定,本申请不作限制。Among them, the
在其他实施例中,如图21与图22,覆膜20还可以采用部分缝合的方式,即缝合线50设置为绕支架本体10外缘的长度小于一整周。采用部分缝合的方式,可以在保证覆膜20结构强度的同时,增强覆膜20与支架本体10之间的结构强度。In other embodiments, as shown in FIG. 21 and FIG. 22 , the
当覆膜20采用部分缝合的方式时,缝合线50可以采用叠层缝合的方式。具体的,缝合线50设置在覆膜20的边缘,并通过内外穿刺的方式缝合线50拉紧覆膜20,为了增强局部的缝合强度,缝合线50在进行内外穿刺时穿刺孔错位设置。When the
通过上述实施方式,使的缝合线50形成若干首尾连接或者错位重叠的缝合圈51,每个缝合圈51均穿过支架本体10的网孔11。优选的,相邻的缝合圈51具有重叠的部分。由于相邻的缝合圈51具有重叠的部分,因此缝合线50整体的缝合强度增加,实现了在不影响覆膜20强度的同时,增强缝合强度的目的。Through the above-mentioned embodiment, the
综上,本实施例通过在支架本体10上增加缝合线50,通过缝合线50将覆膜20缝合在腰部支架段30上,从而增强了覆膜20与支架本体10的结合强度,有效防止覆膜20与支架本体10脱离。To sum up, in this embodiment, by adding
实施例六,本申请的实施例六提供一种气道支架,如图1与图2所示,支架本体10包括腰部支架段30以及两个分别设置在腰部支架段30两端的密网裸支架段40,密网裸支架段40的网孔11的密度大于腰部支架段30的网孔11的密度,覆膜20设置在腰部支架段30上。Embodiment 6. Embodiment 6 of the present application provides an airway stent. As shown in FIG. 1 and FIG. 2 , the
如图23所示,本实施例为了进一步在支架本体10植入气道后,方便支架的撤出或回收,在支架本体10上设置了回收线60。回收线60设置在支架本体10一端的密网裸支架段40上,且回收线60沿密网裸支架段40的边缘穿设。As shown in FIG. 23 , in this embodiment, in order to further facilitate withdrawal or recovery of the stent after the
其中,如图24与图25所示,密网裸支架段40包括内层支撑网41以及外层支撑网42,回收线60至少部分地穿设在内层支撑网41与外层支撑网42之间。回收线60包括连接线61以及操作线62,连接线61至少部分地设在内层支撑网41与外层支撑网42之间,操作线62的一端与连接线61连接,操作线62的另一端位于支架本体10外用于医生操作。Wherein, as shown in FIG. 24 and FIG. 25 , the dense mesh
具体操作时,医生通过拉动操作线62,连接线61在操作线62的带动下,使密网裸支架段40的开口处直径缩小。由于密网裸支架段40的开口处直径缩小,因此密网裸支架段40的开口处会与气道内壁70分离,使得支架本体10与气道内壁70之间的作用力减小,便于医生将气道支架取出。During the specific operation, the doctor pulls the
当密网裸支架段40为单层密集编织网结构时,连接线61沿密网裸支架段40的边缘穿设。当密网裸支架段40为双层或多层编织网结构时,连接线61可以部分位于两层编织网之间,也可以全部位于两层编织网之间。When the dense mesh
在本实施例中,密网裸支架段40为双层编织网结构。连接线61可以部分位于内层支撑网41和外层支撑网42之间,且部分位于外层支撑网42之外。连接线61还可以全部位于内层支撑网41和外层支撑网42之间,当连接线61全部位于内层支撑网41和外层支撑网42之间时,连接线61在移动时受到的摩擦力更小,收缩密网裸支架段40的开口处所需要的的力更小,便于医生的回收操作。In this embodiment, the dense mesh
综上所述,本申请提供的气道支架在腰部支架段上设置覆膜,通过覆膜减少腰部支架段给气道内壁造成的刺激,然后在腰部支架段的两端设置密网裸支架段,且密网裸支架段的孔径相较于腰部支架段的孔径更小。因此,本申请的气道支架在保证密网裸支架段与气道内壁之间锚定力的同时,增大了密网裸支架段与气道内壁之间的接触面积,减少了气道内壁单位面积所受到的压强,使得气道内壁刺激变小,并且,由于腰部支架段的两端采用了密网裸支架段的设计,气道支架两端也不会有分泌物潴留。因此,通过使用本申请的气道支架,能够在不使气道分泌物在气道支架表面潴留的同时,减小气道支架对气道内壁的刺激,从而减少肉芽组织的增生,避免气道再次狭窄的发生。In summary, the airway stent provided by this application is provided with a coating on the lumbar stent section, through which the stimulation to the inner wall of the airway by the lumbar stent section is reduced, and then a dense mesh bare stent section is set at both ends of the lumbar stent section , and the pore diameter of the dense mesh bare stent segment is smaller than that of the lumbar stent segment. Therefore, while the airway stent of the present application ensures the anchoring force between the bare stent section of the dense mesh and the inner wall of the airway, the contact area between the bare stent section of the dense mesh and the inner wall of the airway is increased, and the inner wall of the airway is reduced. The pressure per unit area reduces the irritation of the inner wall of the airway, and since the two ends of the lumbar stent adopt the design of the dense mesh bare stent, there will be no secretion retention at both ends of the airway stent. Therefore, by using the airway stent of the present application, it is possible to reduce the stimulation of the airway stent to the inner wall of the airway without causing the airway secretions to remain on the surface of the airway stent, thereby reducing the hyperplasia of granulation tissue and avoiding airway secretions. Stenosis occurs again.
实施例七Embodiment seven
本申请的实施例七提供一种气道支架,如图26至图28所示,包括支架本体10以及设置在支架本体10上的覆膜20,支架本体10包括腰部支架段30以及设置在腰部支架段30端部的密网裸支架段40,覆膜20设置在腰部支架段30上。本实施例中,密网裸支架段40的网丝的丝径小于腰部支架段30的网丝的丝径,密网裸支架段40为单层密集编织网结构。Embodiment 7 of the present application provides an airway stent, as shown in Fig. 26 to Fig. 28, including a
支架本体10的网丝之间形成有网孔11。密网裸支架段40为外侧无膜结构设置的支架段,腰部支架段30的至少一端设置有密网裸支架段40,由于密网裸支架段40的外侧无膜结构设置,从而不影响气道内壁70纤毛的功能,保证了气道分泌物不会在气道本体上潴留。且本申请的腰部支架段30上设置有覆膜20,从而减少支架本体10对气道内壁70的刺激。Mesh holes 11 are formed between the mesh wires of the
具体的,支架本体10包括多根第一编织丝403以及多根第二编织丝301,密网裸支架段40的网丝为第一编织丝403,密网裸支架段40通过第一编织丝403编织形成,腰部支架段30的网丝为第二编织丝301,腰部支架段30通过第二编织丝301编织形成,第一编织丝403的丝径小于第二编织丝301的丝径,第一编织丝403与第二编织丝301均为形状记忆合金丝,优选镍钛丝。Specifically, the
由于腰部支架段30上设置有覆膜20,因此腰部支架段30的第二编织丝301通过覆膜20与气道内壁70接触,而密网裸支架段40的第一编织丝403直接与气道内壁70接触,容易对气道内壁70造成刺激。因此通过将密网裸支架段40的第一编织丝403的丝径减小,从而减小单根第一编织丝403对气道内壁70的压力,并使得密网裸支架段40更加柔软,进而减小直接与气道内壁70接触的密网裸支架段40对气道内壁70的刺激,防止肉芽组织90生长。Since the
如图28所示,密网裸支架段40的第一编织丝403数量设置为等于腰部支架段30的第二编织丝301数量,通过将第一编织丝403的丝径设置为小于第二编织丝301的网丝的丝径,从而降低单根第一编织丝403对气道内壁70的压强,进而减小密网裸支架段40整体对于气道内壁70的压力,也能够有效减小气道支架对气道内壁70的刺激,防止肉芽组织90增生。As shown in Figure 28, the number of the
进一步地,结合图29与图30所示,密网裸支架段40的第一编织丝403的数量设置为大于腰部支架段30的第二编织丝301的数量。Further, as shown in FIG. 29 and FIG. 30 , the number of the
由于第一编织丝403的丝径相较于第二编织丝301的丝径更小,因此单根第一编织丝403的径向支撑力小于第二编织丝301的径向支撑力。为了进一步提升密网裸支架段40与气道内壁70之间的锚定力,将第一编织丝403的数量设置为大于第二编织丝301的数量。即,通过减小单根网丝的丝径,并增加网丝数量的方式,使得密网裸支架段40对气道内壁70的压力更加均匀。在保证密网裸支架段40整体锚定力的同时,降低了单根网丝对气道内壁70的压力,减少了气道内壁70单位面积所受到的压强,使得气道内壁70刺激变小。Since the diameter of the
在本实施例中,密网裸支架段40与腰部支架段30分体成型,且密网裸支架段40与腰部支架段30通过连接部25固定。In this embodiment, the dense mesh
如图29所示,当密网裸支架段40与腰部支架段30分体成型,且密网裸支架段40与腰部支架段30通过连接部25固定时。连接部25为连接膜,密网裸支架段40与腰部支架段30分别与连接膜连接固定,从而密网裸支架段40与腰部支架段30通过连接膜间接地固定连接。As shown in FIG. 29 , when the dense mesh
在其他实施方式中,如图30所示,连接部25还可以为焊接点,密网裸支架段40的第一编织丝403还可以通过焊接的方式与腰部支架段30的第二编织丝301固定连接。In other embodiments, as shown in FIG. 30 , the connecting
在其他实施方式中,连接部25还可以为钢套(图未示),密网裸支架段40的第一编织丝403和腰部支架段30的第二编织丝301的连接端通过钢套套接固定。In other embodiments, the connecting
需要说明的是,本申请上述对于分段成型的密网裸支架段40和腰部支架段30的连接方式仅仅为示例,任何能够连接密网裸支架段40和腰部支架段30的连接方式均可以应用在本申请中。It should be noted that the above-mentioned connection method of the segmented dense mesh
对于分体成型的密网裸支架段40和腰部支架段30,在分别制作成型以后通过连接部25连接,成型方式简单且结构设计灵活,在设计及生产过程中,可以根据实际需要选择不同的网丝丝径、网丝数量和编织方式,多样化程度高,能够适应各种不同病情的患者的需求。For the dense mesh
其中,如图26与图31所示,覆膜20包括设置在腰部支架段30外表面的外膜22,覆膜20还可以包括设置在腰部支架段30内表面的内膜21,内膜21与外膜22通过腰部支架段30的网孔11进行结合固定。Wherein, as shown in FIG. 26 and FIG. 31 , the covering
具体的,为了进一步阻止气道内的恶性肿瘤80向支架本体10内生长,造成气道内壁70再狭窄或支架本体10不易取出,本实施例在腰部支架段30的外表面覆有一层生物相容性高分子覆膜20,用于进一步阻止恶性肿瘤80向支架本体10内生长。Specifically, in order to further prevent the
其中,覆膜20的材质可选用PET、PTFE、ePTFE、硅胶、聚氨酯等,覆膜20的厚度根据支架本体10编织丝的大小和支架本体10的内外径而调整,本申请不做限制。Among them, the material of the
为了增强覆膜20与支架本体10之间的结合强度,并进一步阻止肿瘤80向内生长,本申请的覆膜20还包括设置在腰部支架段30的内表面的内膜21,由于支架本体10存在网孔11,因此内膜21和外膜22可以通过腰部支架段30的网孔11进行结合固定。其中,内膜21和外膜22可以通过热熔固定,也可以通过粘接固定,内膜21与外膜22的材质可以选择相同或者不同。In order to enhance the bonding strength between the covering
综上所述,根据本申请的气道支架,首先,在腰部支架段30上设置覆膜20,覆膜20既可以减少腰部支架段30给气道内壁70造成的刺激,同时覆膜20还可以阻止肿瘤80向气道支架内部生长。To sum up, according to the airway stent of the present application, firstly, the
其次,在腰部支架段30的端部设置密网裸支架段40,并且所述密网裸支架段40的网丝的丝径小于所述腰部支架段30的网丝的丝径,降低了单根网丝对气道内壁70的压力。本发明进一步将密网裸支架段40的网丝的数量设置为大于腰部支架段30的网丝的数量,从而保证密网裸支架段40与气道内壁70之间锚定力,减少了气道内壁70单位面积所受到的压强,使得气道内壁70受到刺激变小。Secondly, the dense mesh
另外,由于腰部支架段30的两端采用了密网裸支架段40的设计,气道支架两端也不会有分泌物潴留。因此,通过使用本发明的气道支架,能够不使气道分泌物在气道支架表面潴留,阻止肿瘤80向气道支架内部生长,减小气道支架对气道内壁70的刺激从而减少肉芽组织90的增生,避免气道再次狭窄的发生。In addition, because the two ends of the
实施例八Embodiment eight
本申请的实施例七提供一种气道支架,如图32至图34所示,实施例八与实施例七的相同之处不再赘述,实施例八与实施例七的不同之处在于,密网裸支架段40与腰部支架段30一体编织成型。具体的,密网裸支架段40通过第一编织丝403编织形成,腰部支架段30通过第二编织丝301编织形成。多根第一编织丝403相互缠绕形成第二编织丝301。Embodiment 7 of the present application provides an airway stent, as shown in FIG. 32 to FIG. 34 , and the similarities between Embodiment 8 and Embodiment 7 will not be repeated. The difference between Embodiment 8 and Embodiment 7 is that The dense mesh
在支架本体10编织成型的过程包括如下步骤:The process of weaving and molding the
首先,将至少两根第一编织丝403以相互缠绕的形式,制备成第二编织丝301。通过多根制备完成的第二编织丝301编织位于支架本体10腰部位置的腰部支架段30。Firstly, at least two
然后,当腰部支架段30编织成型以后,将腰部支架段30两端未进行编织的网丝拆散,重新形成第一编织丝403。通过多根拆散的第一编织丝403编织位于支架本体10两端的密网裸支架段40。Then, after the
最后,对编织完成的支架本体10进行热定型处理。Finally, heat setting treatment is performed on the
需要说明的是,第二编织丝301可以通过两根第一编织丝403相互缠绕形成,如图35所示,也可以通过三根第一编织丝403相互缠绕编织形成,用于制备第而编织丝的第一编织丝403的数量根据实际需要进行选择。It should be noted that the
另外,支架本体10可以包括一个设置在腰部支架段30一端的密网裸支架段40,支架本体10也可以包括两个分别设置在腰部支架段30两端的密网裸支架段40,具体根据病人的实际病情进行选择。In addition, the
由上,通过一体编织并热定型处理得到的支架本体10柔顺性更好,边缘更加光滑,支架本体10的结构更加牢固,安全性更高。From the above, the
在其他实施方案中,如图36与图37所示,第一编织丝403包括一根主编织丝404以及至少一根副编织丝405,副编织丝405缠绕在主编织丝404上形成第二编织丝301,第二编织丝301编织形成腰部支架段30。具体的,主编织丝404的丝径大于副编织丝405的丝径,在主编织丝404与副编织丝405之间进行缠绕时,副编织丝405呈螺旋状缠绕在主编织丝404上形成第二编织丝301。In other embodiments, as shown in FIG. 36 and FIG. 37 , the
根据本实施方案,一方面,通过设置主编织丝404的方式保证了腰部支架段30的编织结构整体的稳固性,通过增加副编织丝405的方式增加了第二编织丝301的整体径向支撑力。另一方面,通过主编织丝404与副编织丝405混合编织形成的密网裸支架段40,由于副编织丝405的丝径相比主编织丝404的丝径小,因此单根副编织丝405对气道内壁70的压力更小,减少了气道内壁70单位面积所受到的压强,能够进一步减小密网裸支架段40对气道内壁70造成的刺激。According to this embodiment, on the one hand, the overall stability of the braided structure of the
如图36所示,密网裸支架段40的端部包括由多根第一编织丝403汇聚形成的网丝集中点45,当采用副编织丝405缠绕在主编织丝404上形成第二编织丝301的方式时,副编织丝405的头端还可以直接连接在密网裸支架段40的端部,从而减少密网裸支架段40的网丝集中点45的数量,增强了单个网丝集中点45的强度,使得密网裸支架段40的端部的锚定力更强,有效防止支架本体10位移。As shown in Figure 36, the end of the dense mesh
实施例九Embodiment nine
本申请的实施例九提供一种气道支架,如图38至图40所示,实施例九与实施例八的相同之处不再赘述,实施例九与实施例八的不同之处在于,支架本体10还包括至少一根第三编织丝302,腰部支架段30通过第二编织丝301和第三编织丝302混合编织形成,密网裸支架40段通过第一编织丝403和第三编织丝302混合编织形成。第二编织丝301可以通过若干丝径相同的第一编织丝403编织形成,也可以通过丝径不同的主编织丝404和副编织丝405编织形成。Embodiment 9 of the present application provides an airway stent, as shown in FIG. 38 to FIG. 40 , and the similarities between Embodiment 9 and Embodiment 8 will not be repeated. The difference between Embodiment 9 and Embodiment 8 is that The
具体的,在支架本体10制备时,可以通过设置第三编织丝302的丝径和数量,调整支架本体10整体的径向支撑力,还可以调整密网裸支架段40对气道内壁70的压强。Specifically, during the preparation of the
其中,在第二编织丝301与第三编织丝302的总数量不变的情况下,第三编织丝302的丝径越大支架本体10整体的径向支撑力越大。例如,当选择第三编织丝302的丝径大于第二编织丝301的丝径时,可以增加支架本体10整体的径向支撑力;当选择第三编织丝302的丝径大于第一编织丝403的丝径,且小于或等于第二编织丝301的丝径时,可以在保证腰部支架段30的径向支撑力的同时,减小密网裸支架段40的径向支撑力;当选择第三编织丝302的丝径小于或等于第一编织丝403的丝径时,可以减小支架本体10整体的径向支撑力。Wherein, when the total number of the
其中,在第二编织丝301与第三编织丝302的总数量不变的情况下,第三编织丝302的数量越多第二编织丝301的数量越少,则第一编织丝403的数量也越少,密网裸支架段40的网丝数量也越少,因此,密网裸支架段40对气道内壁70的压强越大;反之同理。Wherein, under the condition that the total quantity of the
根据实施例的气道支架,不仅可以防止气道支架两端分泌物潴留,防止肿瘤80向气道支架内部生长,防止肉芽组织90生长。还可以通过灵活调整第一编织丝403、第二编织丝301和第三编织丝302的丝径和数量,灵活调整支架本体10整体的径向支撑力,以及密网裸支架段40对气道内壁70的压强,从而适应不同患者的需求。According to the airway stent of the embodiment, it can not only prevent secretion retention at both ends of the airway stent, prevent
以上,仅为本发明较佳的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到的变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以权利要求的保护范围为准。The above is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Anyone skilled in the art can easily think of changes or substitutions within the technical scope disclosed in the present invention. All should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.
Claims (10)
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| CN202111510933.1A CN116250963A (en) | 2021-12-10 | 2021-12-10 | an airway stent |
| PCT/CN2022/137589 WO2023104157A1 (en) | 2021-12-10 | 2022-12-08 | Airway stent |
| EP22903576.1A EP4445869A4 (en) | 2021-12-10 | 2022-12-08 | Airway stent |
| US18/716,866 US20250312135A1 (en) | 2021-12-10 | 2022-12-08 | Airway Stent |
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