CN209220581U - Double layer covered stent - Google Patents
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- CN209220581U CN209220581U CN201820824324.0U CN201820824324U CN209220581U CN 209220581 U CN209220581 U CN 209220581U CN 201820824324 U CN201820824324 U CN 201820824324U CN 209220581 U CN209220581 U CN 209220581U
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- 229910052751 metal Inorganic materials 0.000 claims abstract description 40
- 239000002184 metal Substances 0.000 claims abstract description 40
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 22
- 230000008093 supporting effect Effects 0.000 claims abstract description 11
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 14
- 239000000956 alloy Substances 0.000 claims description 3
- 238000010147 laser engraving Methods 0.000 claims description 2
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims 2
- 229910045601 alloy Inorganic materials 0.000 claims 1
- 210000000709 aorta Anatomy 0.000 claims 1
- 239000007787 solid Substances 0.000 abstract description 3
- 230000015572 biosynthetic process Effects 0.000 abstract 1
- 239000010410 layer Substances 0.000 description 34
- 239000012528 membrane Substances 0.000 description 12
- 230000000694 effects Effects 0.000 description 7
- 230000023597 hemostasis Effects 0.000 description 6
- 208000001750 Endoleak Diseases 0.000 description 5
- 206010064396 Stent-graft endoleak Diseases 0.000 description 5
- 230000007423 decrease Effects 0.000 description 5
- 210000002376 aorta thoracic Anatomy 0.000 description 4
- 230000002792 vascular Effects 0.000 description 4
- 230000002439 hemostatic effect Effects 0.000 description 2
- 238000002513 implantation Methods 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 208000014674 injury Diseases 0.000 description 2
- 239000007769 metal material Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 239000011148 porous material Substances 0.000 description 2
- 239000002356 single layer Substances 0.000 description 2
- 230000008733 trauma Effects 0.000 description 2
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 208000009443 Vascular Malformations Diseases 0.000 description 1
- 208000024248 Vascular System injury Diseases 0.000 description 1
- 208000012339 Vascular injury Diseases 0.000 description 1
- 230000002159 abnormal effect Effects 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 238000007887 coronary angioplasty Methods 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000000004 hemodynamic effect Effects 0.000 description 1
- 238000002357 laparoscopic surgery Methods 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 208000019553 vascular disease Diseases 0.000 description 1
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Abstract
Description
技术领域technical field
本实用新型涉及医疗器械技术领域,具体涉及一种双层覆膜支架。The utility model relates to the technical field of medical devices, in particular to a double-layer film-covered stent.
背景技术Background technique
支架植入术指的是利用穿刺、导管、球囊导管扩张形成和金属内支架置入等技术,使狭窄、闭塞的血管或腔道扩张、再通,解决传统手术盲区的一种技术。Stent implantation refers to a technology that uses techniques such as puncture, catheter, balloon catheter expansion and metal stent placement to expand and recanalize narrowed or occluded blood vessels or lumens, and solve traditional surgical blind spots.
血管、腔道狭窄、闭塞是介入支架植入技术的治疗强项。具有创伤小、疗效高、风险低、并发症少、住院时间短等优点,为血管、腔道狭窄、闭塞开创了一条新路。以尽可能小的创伤换取同样甚至更高的疗效是外科的发展方向,腹腔镜、冠状动脉扩张成形术在临床的成功应用是典型事例。Stenosis and occlusion of blood vessels and lumens are the treatment strengths of interventional stent implantation technology. It has the advantages of small trauma, high curative effect, low risk, few complications, and short hospital stay, creating a new way for narrowing and occlusion of blood vessels and lumens. It is the development direction of surgery to obtain the same or even higher curative effect with as little trauma as possible. The successful clinical application of laparoscopy and coronary angioplasty is a typical example.
覆膜支架是指金属裸支架内面或外面部分或完全覆盖膜性材料的人工体内移植物。覆膜支架既保留了普通支架的支撑功能,又能有效地改善病变血管的异常血流动力学,从而在外周血管畸形性病变和急慢性血管损伤等血管病变的治疗中得到了广泛的应用。Covered stents refer to artificial internal grafts in which the inner or outer surfaces of bare metal stents are partially or completely covered with membranous materials. The covered stent not only retains the supporting function of the common stent, but also can effectively improve the abnormal hemodynamics of the diseased blood vessel, so it has been widely used in the treatment of peripheral vascular malformation lesions and acute and chronic vascular injuries and other vascular diseases.
目前,覆膜支架通常分为直管型及分叉型,其支架结构通常为单层支架结构,并在部分或全部支架结构部分加覆膜。在部分支架结构覆膜时,部分支架结构为裸支架,裸支架补不能起到隔绝血流的作用,对于夹层或血管破裂出血无法达到止血的作用;在全部支架结构覆膜时,单层支架结构在使用过程中,由于结构不够坚实,容易由于血管变形导致产生覆膜裂口或支架刺破覆膜形成血管内漏。At present, covered stents are generally divided into straight tube type and bifurcated type, and the stent structure is usually a single-layer stent structure, and a covering is added to part or all of the stent structure. When part of the stent structure is covered with a membrane, part of the stent structure is a bare stent, and the bare stent cannot isolate the blood flow, and cannot achieve hemostasis for dissection or blood vessel rupture; when the entire stent structure is covered with a membrane, the single-layer stent During the use of the structure, because the structure is not firm enough, it is easy to cause a membrane crack due to blood vessel deformation or the stent punctures the membrane to form a vascular endoleak.
实用新型内容Utility model content
本实用新型针对现有技术,提供了一种双层覆膜支架,采用外层支架和内层支架的双层支架结构,并将生物膜覆在外层支架与内层支架之间,形成坚实的支架结构,使支架结构不易变形,减少支架结构变形导致的覆膜裂口和支架刺破覆膜形成的血管内漏。Aiming at the prior art, the utility model provides a double-layer film-covered stent, which adopts a double-layer stent structure of an outer layer stent and an inner layer stent, and covers the biofilm between the outer layer stent and the inner layer stent to form a solid The stent structure makes the stent structure not easy to deform, and reduces the membrane gap caused by the deformation of the stent structure and the vascular endoleak caused by the stent piercing the membrane.
本实用新型通过下述技术方案实现:所述双层覆膜支架,为紧密贴合在血管壁内侧的管状结构,包括支架结构和覆在支架结构上的生物膜,所述支架结构包括金属内层支架和套设在金属内层支架外的金属外层支架,所述生物膜覆在外层支架和内层支架之间。The utility model is realized through the following technical scheme: the double-layer covered stent is a tubular structure closely attached to the inner side of the blood vessel wall, including a stent structure and a biofilm covering the stent structure, and the stent structure includes a metal inner layer stent and a metal outer stent sheathed outside the metal inner stent, and the biofilm is covered between the outer stent and the inner stent.
所述生物膜覆设在金属外层支架与金属内层支架之间且与金属外层支架内表面、金属内层支架外表面紧密贴合,使其紧密贴合在血管壁内侧,达到良好的止血效果。所述双层覆膜支架的外径略大于血管的内径,双层覆膜支架植入后,双层覆膜支架与血管内壁紧密贴合,使其达到止血的作用。由于外层支架和内层支架的支撑作用,使生物膜内外受力均匀,使生物膜不易变形、破损、破裂,避免覆膜裂口和支架刺破覆膜形成的血管内漏。The biofilm is covered between the outer metal stent and the inner metal stent and closely adheres to the inner surface of the outer metal stent and the outer surface of the inner metal stent, so that it is closely attached to the inner side of the blood vessel wall to achieve a good Hemostatic effect. The outer diameter of the double-layer stent-graft is slightly larger than the inner diameter of the blood vessel. After the double-layer stent-graft is implanted, the double-layer stent-graft adheres closely to the inner wall of the blood vessel to achieve the effect of hemostasis. Due to the supporting effect of the outer stent and the inner stent, the internal and external forces of the biofilm are uniform, so that the biofilm is not easily deformed, damaged, and ruptured, and the vascular endoleak formed by the membrane crack and the stent piercing the membrane is avoided.
进一步地,当所述双层覆膜支架设置在近端和远端血管直径均逐渐减小的胸主动脉时,所述双层覆膜支架两端设置有向双层覆膜支架两端端部延伸的锥度,即双层覆膜支架两端的直径随着胸主动脉的近端和远端的血管直径的减小而逐渐减小,双层覆膜支架两端形成直径从中间到两端逐渐变小的锥形。Further, when the double-layer stent-graft is placed on the thoracic aorta where the proximal and distal vessel diameters gradually decrease, the two ends of the double-layer stent-graft are provided with The taper of the extension, that is, the diameter at both ends of the double-layer covered stent gradually decreases with the decrease of the diameter of the proximal and distal vessels of the thoracic aorta, and the diameter at both ends of the double-layer covered stent is from the middle to the two ends. Tapering taper.
进一步地,所述金属内层支架和金属外层支架均为镍钛合金丝编织而成或采用镍钛合金薄管激光雕刻而成。Further, the inner metal stent and the outer metal stent are both braided from nickel-titanium alloy wire or laser-engraved from a nickel-titanium alloy thin tube.
支架部分常采用镍钛合金等具有优良机械性能的金属材料,以提供足够的支撑力。镍钛合金材料还具有形状记忆特性,能将自身的塑性变形在某一特定温度下自动恢复为原始形状,使其具有弹性且能恢复形状。采用镍钛合金丝编织而成的金属内层支架和金属外层支架,具有大量的镂空孔隙,由于镍钛合金丝很细,编织而成的金属内层支架和金属外层支架的厚度很薄,双层覆膜支架的外层支架会嵌入血管内,具有弹性的生物膜和血管紧密贴合,达到止血的效果。采用激光雕刻而成的金属内层支架和金属外层支架,雕刻后形成既定的镂空孔隙,具有弹性的生物膜和血管在孔隙内紧密贴合,达到止血的效果。Metal materials with excellent mechanical properties, such as nickel-titanium alloy, are often used for the bracket part to provide sufficient support. Nickel-titanium alloy materials also have shape memory properties, which can automatically restore their own plastic deformation to their original shape at a certain temperature, making them elastic and capable of restoring their shape. The metal inner stent and the metal outer stent braided by nickel-titanium alloy wire have a large number of hollow pores. Because the nickel-titanium alloy wire is very thin, the thickness of the braided metal inner stent and metal outer stent is very thin , the outer stent of the double-layer covered stent will be embedded in the blood vessel, and the elastic biofilm will fit closely with the blood vessel to achieve the effect of hemostasis. The metal inner stent and the metal outer stent are laser-engraved to form a predetermined hollow hole, and the elastic biofilm and blood vessels fit closely in the hole to achieve the effect of hemostasis.
本实用新型所提供的一种双层覆膜支架,采用外层支架和内层支架的双层支架结构,并将生物膜覆在外层支架与内层支架之间,形成坚实的支架结构,使支架结构不易变形,减少支架结构变形导致的覆膜裂口和支架刺破覆膜形成的血管内漏。A double-layer film-covered stent provided by the utility model adopts a double-layer stent structure of an outer layer stent and an inner layer stent, and covers the biofilm between the outer layer stent and the inner layer stent to form a solid stent structure, so that The stent structure is not easy to deform, reducing the membrane gap caused by the deformation of the stent structure and the vascular endoleak caused by the stent piercing the membrane.
附图说明Description of drawings
图1为本实用新型结构示意图;Fig. 1 is the structural representation of the utility model;
图中:1—金属外层支架,2—金属内层支架,3—生物膜。In the figure: 1—metal outer stent, 2—metal inner stent, 3—biofilm.
具体实施方式Detailed ways
下面结合实施例对本实用新型作进一步地详细说明,但本实用新型的实施方式不限于此。The utility model will be further described in detail below in conjunction with the examples, but the implementation of the utility model is not limited thereto.
实施例1Example 1
如图1所示,所述双层覆膜支架,为紧密贴合在血管壁内侧的管状结构,包括支架结构和覆在支架结构上的生物膜3,所述支架结构包括金属内层支架2和套设在金属内层支架2外的金属外层支架1,所述生物膜3覆在金属外层支架1和金属内层支架2之间。As shown in Figure 1, the double-layer covered stent is a tubular structure closely attached to the inside of the blood vessel wall, including a stent structure and a biofilm 3 covering the stent structure, and the stent structure includes a metal inner layer stent 2 and the outer metal stent 1 sheathed outside the inner metal stent 2 , the biofilm 3 is covered between the outer metal stent 1 and the inner metal stent 2 .
所述生物膜3覆设在金属外层支架1与金属内层支架2之间且与金属外层支架1内表面、金属内层支架2外表面紧密贴合,使其紧密贴合在血管壁内侧,达到良好的止血效果。所述双层覆膜支架的外径略大于血管的内径,双层覆膜支架植入后,双层覆膜支架与血管内壁紧密贴合,使其达到止血的作用。由于外层支架和内层支架的支撑作用,使生物膜3内外受力均匀,使生物膜3不易变形、破损、破裂,避免覆膜裂口和支架刺破覆膜造成的血管内漏。The biofilm 3 is covered between the outer metal stent 1 and the inner metal stent 2 and closely adheres to the inner surface of the outer metal stent 1 and the outer surface of the inner metal stent 2, so that it is closely attached to the blood vessel wall Medial, to achieve a good hemostatic effect. The outer diameter of the double-layer stent-graft is slightly larger than the inner diameter of the blood vessel. After the double-layer stent-graft is implanted, the double-layer stent-graft adheres closely to the inner wall of the blood vessel to achieve the effect of hemostasis. Due to the supporting effect of the outer stent and the inner stent, the internal and external force of the biofilm 3 is uniform, so that the biofilm 3 is not easily deformed, damaged, and ruptured, and the endoleak caused by the membrane gap and the stent piercing the membrane is avoided.
实施例2Example 2
本实施例是在实施例1的基础上进行改进,其改进之处在于:当所述双层覆膜支架设置在近端和远端血管直径逐渐减小的胸主动脉时,所述双层覆膜支架两端设置有向双层覆膜支架两端端部延伸的锥度,即双层覆膜支架两端的直径随着胸主动脉的近端和远端的血管直径的减小而逐渐减小,双层覆膜支架两端形成直径从中间到两端逐渐变小的锥形。This embodiment is improved on the basis of Embodiment 1. The improvement is that: when the double-layer covered stent-graft is placed on the thoracic aorta where the proximal and distal vessel diameters gradually decrease, the double-layer The two ends of the stent-graft are provided with tapers extending toward the two ends of the double-layer stent-graft, that is, the diameters of the two ends of the double-layer stent-graft gradually decrease with the diameter of the blood vessels at the proximal and distal ends of the thoracic aorta. Small, double-layered stent-grafts form a taper at both ends that tapers in diameter from the middle to the ends.
本实施例中其他部分与实施例1基本相同,故不再一一赘述。Other parts in this embodiment are basically the same as those in Embodiment 1, so details will not be repeated one by one.
实施例3Example 3
本实施例是在实施例1或2的基础上进行改进,其改进之处在于:所述金属内层支架2和金属外层支架1均为镍钛合金丝编织。This embodiment is improved on the basis of Embodiment 1 or 2, and the improvement is that: the inner metal stent 2 and the outer metal stent 1 are braided with nickel-titanium alloy wires.
支架部分常采用镍钛合金等具有优良机械性能的金属材料,以提供足够的支撑力。镍钛合金材料还具有形状记忆特性,能将自身的塑性变形在某一特定温度下自动恢复为原始形状,使其具有弹性且能恢复形状。采用镍钛合金丝编织而成的金属内层支架2和金属外层支架1,具有大量的镂空孔隙,由于镍钛合金丝很细,编织而成的金属内层支架2和金属外层支架1的厚度很薄,双层覆膜支架的外层支架会嵌入血管内,具有弹性的生物膜3和血管紧密贴合,达到止血的效果。Metal materials with excellent mechanical properties, such as nickel-titanium alloy, are often used for the bracket part to provide sufficient support. Nickel-titanium alloy materials also have shape memory properties, which can automatically restore their own plastic deformation to their original shape at a certain temperature, making them elastic and capable of restoring their shape. The metal inner stent 2 and the metal outer stent 1 braided by nickel-titanium alloy wire have a large number of hollow pores. Since the nickel-titanium alloy wire is very thin, the braided metal inner stent 2 and metal outer stent 1 The thickness of the double-layer stent graft is very thin, and the outer stent of the double-layer covered stent will be embedded in the blood vessel, and the elastic biofilm 3 fits closely with the blood vessel to achieve the effect of hemostasis.
所述金属外层支架1和技术内层支架还可以均采用镍钛合金薄管激光雕刻而成。Both the metal outer stent 1 and the technical inner stent can also be formed by laser engraving of nickel-titanium alloy thin tubes.
以上所述,仅是本实用新型的较佳实施例,并非对本实用新型做任何形式上的限制,凡是依据本实用新型的技术实质对以上实施例所作的任何简单修改、等同变化,均落入本实用新型的保护范围之内。The above is only a preferred embodiment of the utility model, and does not limit the utility model in any form. Any simple modification or equivalent change made to the above embodiments according to the technical essence of the utility model falls within the scope of the present utility model. Within the protection scope of the present utility model.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112206030A (en) * | 2020-11-11 | 2021-01-12 | 北京久事神康医疗科技有限公司 | Covered stent |
| WO2022222684A1 (en) * | 2021-04-19 | 2022-10-27 | 珠海原妙医学科技股份有限公司 | Ureteral stent and manufacturing method |
| CN119587100A (en) * | 2024-11-15 | 2025-03-11 | 广东三九脑科医院 | A dense mesh bracket |
| CN120732581A (en) * | 2025-08-22 | 2025-10-03 | 北京华脉泰科医疗器械股份有限公司 | Aortic tectorial membrane support and aortic stent system |
-
2018
- 2018-05-30 CN CN201820824324.0U patent/CN209220581U/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112206030A (en) * | 2020-11-11 | 2021-01-12 | 北京久事神康医疗科技有限公司 | Covered stent |
| WO2022222684A1 (en) * | 2021-04-19 | 2022-10-27 | 珠海原妙医学科技股份有限公司 | Ureteral stent and manufacturing method |
| CN119587100A (en) * | 2024-11-15 | 2025-03-11 | 广东三九脑科医院 | A dense mesh bracket |
| CN119587100B (en) * | 2024-11-15 | 2025-08-15 | 广东三九脑科医院 | Close net support |
| CN120732581A (en) * | 2025-08-22 | 2025-10-03 | 北京华脉泰科医疗器械股份有限公司 | Aortic tectorial membrane support and aortic stent system |
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