CN110279499A - 抗菌亲水硅酮支架 - Google Patents
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- JQXXHWHPUNPDRT-WLSIYKJHSA-N rifampicin Chemical compound O([C@](C1=O)(C)O/C=C/[C@@H]([C@H]([C@@H](OC(C)=O)[C@H](C)[C@H](O)[C@H](C)[C@@H](O)[C@@H](C)\C=C\C=C(C)/C(=O)NC=2C(O)=C3C([O-])=C4C)C)OC)C4=C1C3=C(O)C=2\C=N\N1CC[NH+](C)CC1 JQXXHWHPUNPDRT-WLSIYKJHSA-N 0.000 claims 1
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/821—Ostial stents
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
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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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
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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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
- A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
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Abstract
本发明涉及医疗器械技术领域，提供了一种抗菌亲水硅酮支架，包括具有双层管状结构的支架主体，所述支架主体包括内管和同轴套设在所述内管外部的外管；所述外管的内径比内管的外径长0.15至0.2毫米；所述内管和外管的侧壁上均设有多个均匀分布的贯穿的微孔，所述微孔直径为0.008至0.01毫米。本发明提供的硅酮支架在具有较好的支撑性能的同时，不会对患者气道内部产生刺激，同时还能对气道起润滑、消炎抗菌等作用。
Description
技术领域
本发明涉及医疗器械技术领域，具体涉及一种抗菌亲水硅酮支架。
背景技术
人呼吸时，空气经气管和支气管进入肺部，因炎性肉芽肿、创伤、肿瘤等病变导致的气管及支气管狭窄，可引起阻塞性肺炎、呼吸困难等症状，严重的可能会危及生命。气管支架置入是治疗气道狭窄的重要手段之一，目前应用最广泛的是由镍钛记忆合金等材料制成的金属支架。与金属材料相比，采用医疗硅酮材料制备气管支架具有诸多优点：由于材料柔软、弹性佳，可以做到无损置入，放置后能够快速恢复到原来的形状，且方便取出；生物相容性好，对人体产生的刺激小。
但是由于硅酮材料对粘液具有吸附性，使得硅酮支架置入患者气道病变位置一段时间后容易发生粘液堵塞，从而影响气流正常通过，进而重新引起患者呼吸困难，使得硅酮支架置入部位容易发生一定程度的感染。
发明内容
本发明提供了一种新的硅酮支架，用于解决现有硅酮支架置入患者气道后容易发生粘液堵塞，从而导致感染的问题。
本发明的目的在于提供一种抗菌亲水硅酮支架，包括具有双层管状结构的支架主体，所述支架主体包括内管和同轴套设在所述内管外部的外管；所述外管的内径比内管的外径大0.15至0.2毫米；所述内管和外管的侧壁上均设有多个均匀分布的贯穿的微孔，所述微孔的直径为0.008至0.01毫米。
进一步地，所述内管两端分别与所述外管两端密封连接后，所述内管和外管之间形成用于储存药物的载药腔。
进一步地，所述载药腔内储存有质量比为100至300的亲水润滑液和抗菌药物，所述亲水润滑液为聚乙二醇和/或端氨基聚乙二醇；所述抗菌药物为聚六亚甲基胍和/或利福平。
进一步地，所述内管和外管均由医用级硅酮材料制成，所述外管的邵氏硬度为30至50HA；所述内管的邵氏硬度为65至75HA。
本发明提供的抗菌亲水硅酮支架结构简单，通过设置双层管状结构，在对气道起较好支撑作用的同时，不会对气道内部产生刺激；此外，利用内管和外管之间的载药腔存储亲水润滑液和抗菌药物还能够对气道起润滑、消炎抗菌等作用。
附图说明
图1是本发明第一实施例中抗菌亲水硅酮支架结构示意图。
图2是本发明第一实施例中抗菌亲水硅酮支架的俯视图 。
图3是图2中A-A面的剖视图。
具体实施方式
为了使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及实施方式，对本发明进行进一步详细说明。
参考图1、图2，本发明第一实施例提供了一种抗菌亲水硅酮支架1，包括支架主体11，所述支架主体11为双层管状结构，包括内管111和同轴套设在所述内管111外部的外管112；所述外管112的内径比内管111的外径长0.15至0.2毫米；所述内管111和外管112的侧壁上均设有多个均匀分布的贯穿的微孔12，所述微孔12的直径为0.008至0.01毫米。
手术时，可以是直接将定制长度的硅酮支架置入患者体内，也可以是根据需要将较长的硅酮支架管体裁剪成特定的长度，再置入患者体内。当手术中使用定制长度的硅酮支架时，所述内管和外管两端分别与所述外管两端密封连接后，所述内管和外管之间形成用于储存药物的载药腔；当手术时需要根据需要裁剪硅酮支架时，可以在裁剪后再将硅酮支架内管两端与外管两端密封连接。
进一步地，所述载药腔内储存有质量比为100至300的亲水润滑液和抗菌药物，所述亲水润滑液位聚乙二醇和/或端氨基聚乙二醇；所述抗菌药物为聚六亚甲基胍和/或利福平。所述亲水润滑液和抗菌药物可以是在内管和外管端部密封连接前注入载药腔。
本实施例通过设置双层管状结构的硅酮支架，从而可以利用内管和外管之间的载药腔存储亲水润滑液和抗菌药物；硅酮支架置入患者气道病变位置后，硅酮支架内外管在气道中受挤压，使得载药腔内的亲水润滑液和抗菌药物不断从微孔中向外部释放，在硅酮支架对气道起支撑作用的同时还能够对气道起润滑、消炎抗菌等治疗作用，有效避免了硅酮支架置入后发生再堵塞。
进一步地，所述硅酮支架1还包括多个均匀设置在外管112外壁上的防滑钉13。本方案的防滑钉能够卡在患者气道部位，避免硅酮支架置入后发生移位或滑落。
进一步地，所述内管和外管均由医用级硅酮材料制成，所述外管的邵氏硬度为30至50HA；所述内管的邵氏硬度为65至75HA。本方案的内管硬度相对较大，能够对气道起较好的支撑作用，外管柔性较好，能够减少对气道内部的刺激。
以上所述仅为本发明的较佳实施方式而已，并不用以限制本发明，凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等，均应包含在本发明的保护范围之内。
Claims (4)
1.一种抗菌亲水硅酮支架，其特征在于，包括具有双层管状结构的支架主体，所述支架主体包括内管和同轴套设在所述内管外部的外管；所述外管的内径比内管的外径大0.15至0.2毫米；所述内管和外管的侧壁上均设有多个均匀分布的贯穿的微孔，所述微孔的直径为0.008至0.01毫米。
2.根据权利要求1所述的抗菌亲水硅酮支架，其特征在于，所述内管两端分别与所述外管两端密封连接后，所述内管和外管之间形成用于储存药物的载药腔。
3.根据权利要求2所述的抗菌亲水硅酮支架，其特征在于，所述载药腔内储存有质量比为100至300的亲水润滑液和抗菌药物，所述亲水润滑液为聚乙二醇和/或端氨基聚乙二醇；所述抗菌药物为聚六亚甲基胍和/或利福平。
4.根据权利要求3所述的带抗菌亲水硅酮支架，其特征在于，所述内管和外管均由医用级硅酮材料制成，所述外管的邵氏硬度为30至50HA；所述内管的邵氏硬度为65至75HA。
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Cited By (2)
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| CN112998906A (zh) * | 2021-01-25 | 2021-06-22 | 广州睿康医疗科技有限公司 | 一种多层复合结构载药气道支架及其制备方法 |
| CN114010366A (zh) * | 2021-12-18 | 2022-02-08 | 山东百多安医疗器械股份有限公司 | 一种抗菌仿生硅胶气道支架及其制备方法 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112998906A (zh) * | 2021-01-25 | 2021-06-22 | 广州睿康医疗科技有限公司 | 一种多层复合结构载药气道支架及其制备方法 |
| CN114010366A (zh) * | 2021-12-18 | 2022-02-08 | 山东百多安医疗器械股份有限公司 | 一种抗菌仿生硅胶气道支架及其制备方法 |
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Address after: Longgang District of Shenzhen City, Guangdong province 518116 Longgang Street Community 6 new road bridge Baolong Baolong Industrial Park building B building 1-3 floor Applicant after: Shenzhen meimeimeichuangyi Medical Technology Co., Ltd Address before: Longgang District of Shenzhen City, Guangdong province 518116 Longgang Street Community 6 new road bridge Baolong Baolong Industrial Park building B building 1-3 floor Applicant before: MEHOW INNOVATIVE Ltd. |
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Application publication date: 20190927 |