CN110604639B - 治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法 - Google Patents
治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法 Download PDFInfo
- Publication number
- CN110604639B CN110604639B CN201910765784.XA CN201910765784A CN110604639B CN 110604639 B CN110604639 B CN 110604639B CN 201910765784 A CN201910765784 A CN 201910765784A CN 110604639 B CN110604639 B CN 110604639B
- Authority
- CN
- China
- Prior art keywords
- copper core
- winding
- flow guide
- guide pipe
- bracket
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 230000000740 bleeding effect Effects 0.000 title claims abstract description 25
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 9
- 206010046996 Varicose vein Diseases 0.000 title abstract description 15
- 208000027185 varicose disease Diseases 0.000 title description 6
- 210000002599 gastric fundus Anatomy 0.000 title description 4
- 239000008280 blood Substances 0.000 claims abstract description 46
- 210000004369 blood Anatomy 0.000 claims abstract description 45
- 239000010408 film Substances 0.000 claims abstract description 22
- 239000000463 material Substances 0.000 claims abstract description 19
- 239000010409 thin film Substances 0.000 claims abstract description 15
- 208000000624 Esophageal and Gastric Varices Diseases 0.000 claims abstract description 13
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 12
- 238000004804 winding Methods 0.000 claims description 38
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical group [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims description 35
- 229910052751 metal Inorganic materials 0.000 claims description 14
- 239000002184 metal Substances 0.000 claims description 14
- 239000011248 coating agent Substances 0.000 claims description 10
- 238000000576 coating method Methods 0.000 claims description 10
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical group [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 claims description 9
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 9
- 230000017531 blood circulation Effects 0.000 claims description 7
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 6
- 238000002844 melting Methods 0.000 claims description 6
- 230000008018 melting Effects 0.000 claims description 6
- 239000000741 silica gel Substances 0.000 claims description 6
- 229910002027 silica gel Inorganic materials 0.000 claims description 6
- 229920000840 ethylene tetrafluoroethylene copolymer Polymers 0.000 claims description 5
- 238000000034 method Methods 0.000 claims description 5
- 229920000728 polyester Polymers 0.000 claims description 4
- -1 polytetrafluoroethylene Polymers 0.000 claims description 4
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 4
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 4
- 229920002635 polyurethane Polymers 0.000 claims description 4
- 239000004814 polyurethane Substances 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 3
- 206010051012 Gastric varices Diseases 0.000 claims 2
- 210000003462 vein Anatomy 0.000 abstract description 17
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 abstract description 9
- 229910052731 fluorine Inorganic materials 0.000 abstract description 9
- 239000011737 fluorine Substances 0.000 abstract description 9
- 206010052211 Oesophageal rupture Diseases 0.000 abstract description 6
- 210000003240 portal vein Anatomy 0.000 abstract description 5
- 230000009977 dual effect Effects 0.000 abstract description 4
- 208000032843 Hemorrhage Diseases 0.000 description 23
- 208000034158 bleeding Diseases 0.000 description 21
- 208000005189 Embolism Diseases 0.000 description 5
- 208000027418 Wounds and injury Diseases 0.000 description 4
- 210000004185 liver Anatomy 0.000 description 4
- 208000007232 portal hypertension Diseases 0.000 description 3
- 230000002792 vascular Effects 0.000 description 3
- 206010003445 Ascites Diseases 0.000 description 2
- 206010016654 Fibrosis Diseases 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 230000001154 acute effect Effects 0.000 description 2
- 230000007882 cirrhosis Effects 0.000 description 2
- 208000019425 cirrhosis of liver Diseases 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000003073 embolic effect Effects 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 230000023597 hemostasis Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000010992 reflux Methods 0.000 description 2
- 210000002784 stomach Anatomy 0.000 description 2
- 241001391944 Commicarpus scandens Species 0.000 description 1
- 206010062713 Haemorrhagic diathesis Diseases 0.000 description 1
- 208000032456 Hemorrhagic Shock Diseases 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- 208000002151 Pleural effusion Diseases 0.000 description 1
- 208000006193 Pulmonary infarction Diseases 0.000 description 1
- 206010040047 Sepsis Diseases 0.000 description 1
- 206010049771 Shock haemorrhagic Diseases 0.000 description 1
- GXBMIBRIOWHPDT-UHFFFAOYSA-N Vasopressin Natural products N1C(=O)C(CC=2C=C(O)C=CC=2)NC(=O)C(N)CSSCC(C(=O)N2C(CCC2)C(=O)NC(CCCN=C(N)N)C(=O)NCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(CCC(N)=O)NC(=O)C1CC1=CC=CC=C1 GXBMIBRIOWHPDT-UHFFFAOYSA-N 0.000 description 1
- 102000002852 Vasopressins Human genes 0.000 description 1
- 108010004977 Vasopressins Proteins 0.000 description 1
- 229940030225 antihemorrhagics Drugs 0.000 description 1
- KBZOIRJILGZLEJ-LGYYRGKSSA-N argipressin Chemical compound C([C@H]1C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CSSC[C@@H](C(N[C@@H](CC=2C=CC(O)=CC=2)C(=O)N1)=O)N)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)NCC(N)=O)C1=CC=CC=C1 KBZOIRJILGZLEJ-LGYYRGKSSA-N 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 206010008118 cerebral infarction Diseases 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000003628 erosive effect Effects 0.000 description 1
- 208000006750 hematuria Diseases 0.000 description 1
- 208000031169 hemorrhagic disease Diseases 0.000 description 1
- 239000002874 hemostatic agent Substances 0.000 description 1
- 230000002440 hepatic effect Effects 0.000 description 1
- 208000021760 high fever Diseases 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000003908 liver function Effects 0.000 description 1
- 238000012148 non-surgical treatment Methods 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 206010034674 peritonitis Diseases 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 230000002784 sclerotic effect Effects 0.000 description 1
- 208000013223 septicemia Diseases 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000002054 transplantation Methods 0.000 description 1
- 231100000216 vascular lesion Toxicity 0.000 description 1
- 229960003726 vasopressin Drugs 0.000 description 1
Classifications
-
- 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
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- 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
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- 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
- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Gastroenterology & Hepatology (AREA)
- Pulmonology (AREA)
- Prostheses (AREA)
Abstract
本发明涉及治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法，所述限流器包括血液流入支架和导流管，血液流入支架由金属丝线螺旋缠绕而成，导流管为薄膜管，血液流入支架内径与导流管内径一致，且血液流入支架与导流管之间采用热熔固定连接。本发明前端支架贴附血管壁后，紧连支架的导流管可直接将血液导流到薄膜管的远端，从而实现了在分流的同时将血液通过支架后的导流管限流到导流管的远端；导流管的设置相当于在迂曲的静脉内增加一层氟材料薄膜，从而大大增加曲张静脉周围的组织支持度，减少静脉曲张破裂出血并保持人体自然建立的静脉分流通道，达到降低门静脉压力和增加曲张静脉壁的支持的双重作用。
Description
技术领域
本发明涉及医疗器械技术领域，具体涉及一种治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法。
背景技术
食管胃底静脉曲张是门静脉高压的主要临床表现之一，而导致门静脉高压最常见的病因是肝硬化。肝硬化病人中有40％出现食管胃底静脉曲张，而有食管胃底静脉曲张的病人中约有50％-60％并发大出血，其突出特点为出血量较大、来势迅猛、病情凶险、病死率高达40％以上，如不及时治疗，患者可因急性大出血发生失血性休克而导致严重后果。曲张静脉的压力和周围组织的支撑力是影响出血的两个最主要因素，血管曲张到一定程度，如其周围有坚强的组织支持，则不至于破裂。但支持组织黏膜面可因炎症、糜烂等局部因素所损伤，使组织支撑力量减弱而易于破裂。当曲张静脉张力增加到高度危险的程度时，任何增加门静脉压力的因素，或周围支持组织有任何缺陷，都会促使曲张静脉破裂出血。以往的治疗手段包括休息、饮食、增强免疫力、保护肝脏、病因治疗、止血剂、输血、气囊压迫止血、硬化治疗、外科手术治疗、肝移植和放射介入治疗。
目前的非外科手术治疗中(经皮经肝胃冠状静脉栓塞术(PTVE)、经皮经肝门静脉栓塞术(PTO))近期止血率和再出血率均优于血管加压素、气囊压迫和硬化治疗，特别是胃底静脉曲张，硬化治疗无法进行，PTO却可有效地止血。但PTO除要求有一定技术条件外，还可发生门脉血栓、肺或脑梗死、腹膜炎、血尿、右侧胸腔积液和败血症等并发症，其发生率可达25％～40％，而且PTO不能降低门脉压。故严重出血倾向、严重肝功能损伤、高热、大量腹水和穿刺途径中血管病变如癌栓或血栓形成均为禁忌。经颈静脉肝内门体分流术(TIPS)主要用以治疗门脉高压曲张静脉出血，还可治疗顽固性腹水和各种原因形成的门脉高压症等。临床应用效果显著，受到广泛的重视，国内外应用者日益增多。但急性出血的再出血率较高，30天病死率为3.6％～19.6％。
发明内容
为此，本发明提供了一种治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法，借助介入技术，通过该限流器可分流血液，并限制导引血液通过加固的通道进入体静脉从而减少静脉曲张破裂出血并保持人体自然建立的静脉分流通道，达到降低门静脉压力和增加曲张静脉壁的支持的双重作用。
为解决上述技术问题，本发明采用如下技术方案：
治疗食管胃底静脉曲张及其破裂出血的血管内限流器，包括血液流入支架和导流管，所述血液流入支架由金属丝线螺旋缠绕而成，所述导流管为薄膜管，所述血液流入支架内径与所述导流管内径一致，且所述血液流入支架与所述导流管之间采用热熔固定连接。
所述金属丝线为外径0.10-0.15mm的镍钛丝。
所述血液流入支架由镍钛丝双向交叉螺旋缠绕而成。
所述导流管采用柔软度好、且可随血流方向与血管壁贴合的薄膜管制作而成。
优选地，所述导流管为ETFE薄膜管。
所述血液流入支架内侧还可包覆一层覆膜。
所述覆膜为涂覆的医用硅胶或膜性材料并延伸到所述导流管。
所述膜性材料为聚四氟乙烯、涤纶、聚脂、聚氨基甲酸乙酯中的一种。
一种治疗食管胃底静脉曲张及其破裂出血的血管内限流器制作方法，包括以下步骤：
S1、取等径的铜芯棒，并在铜芯棒上间隔设置两组沿其周向设置的多个小孔，每个小孔中***与小孔孔径相匹配的铜芯小棒，形成两组铜芯小棒；
S2、取一根金属丝按照预设的第一缠绕角度呈对角交替缠绕在两组铜芯小棒上，完成对两组所有铜芯小棒的缠绕，形成第一层缠绕网；
S3、按照预设的第二缠绕角度呈对角交替缠绕在两组铜芯小棒上，完成对两组所有铜芯小棒的缠绕，形成与第一层缠绕网交织设置的第二层缠绕网，缠绕后的第二层缠绕网与第一层缠绕网形成一个编织金属丝网；
S4、将步骤S3中编织好的编织金属丝网连同铜芯棒一起置入温度为330-370℃下热处理15-30min，得到预成型支架；
S5、取薄膜管一根，将其一端与所述步骤S4制得的预成型支架的端部采用热熔方法连接在一起，即可得到所需限流器。
S6、还可在步骤S4制备的限流器的血液流入支架内侧采用医用硅胶或膜性材料涂覆处理并延伸到导流管。
所述步骤S1中铜芯棒的外径为6-10mm，在铜芯棒上沿其周向每隔45度设置外径为0.3mm-0.7mm。
本发明技术方案，具有如下优点：
本发明治疗食管胃底静脉曲张及其破裂出血的血管内限流器，由前端血液流入支架，后端氟材料薄膜管构成的导流管组成。前端支架贴附血管壁后，紧连支架的导流管可直接将血液导流到薄膜管的远端，从而实现了在分流的同时将血液通过支架后的导流管限流到导流管的远端。因此，血液流经该区域时由于是限制在导流管腔内流动，不会对该区域里的血管壁产生负荷加重的影响，不会使分流静脉床出现迂曲血液回流困难、继发扩张。即支架的后方连接长段的氟材料薄膜管的限流器，相当于在迂曲的静脉内增加一层氟材料薄膜，从而大大增加曲张静脉周围的组织支撑度，并限制导引血液通过加固的通道进入体静脉从而减少静脉曲张破裂出血并保持人体自然建立的静脉分流通道，达到降低门静脉压力和增加曲张静脉壁的支持的双重作用，而当导流管的薄膜管伸展不佳时，可作为栓塞材料将迂曲之静脉栓塞阻断血流。
附图说明
为了更清楚地说明本发明具体实施方式，下面将对具体实施方式中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本发明的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明中限流器整体结构示意图；
图2为本发明中带覆膜的限流器结构中血液流入支架断面图；
图3为本发明中限流器镍钛丝网编织示意图。
附图标记说明：
1-血液流入支架；2-导流管；3-覆膜。
具体实施方式
下面将结合附图对本发明的技术方案进行清楚、完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
如图1所示，本发明提供了一种治疗食管胃底静脉曲张及其破裂出血的血管内限流器，包括血液流入支架1和导流管2，血液流入支架1由金属丝线螺旋缠绕而成，导流管2为薄膜管，血液流入支架1内径与导流管2内径一致，且血液流入支架1与导流管2之间采用热熔固定连接。本发明治疗食管胃底静脉曲张及其破裂出血的血管内限流器，由前端血液流入支架，后端氟材料薄膜管构成的导流管组成。前端支架贴附血管壁后，紧连支架的导流管可直接将血液导流到薄膜管的远端，从而实现了在分流的同时将血液通过支架后的导流管限流到导流管的远端。因此，血流流经该区域时由于是限制在导流管腔内流动，不会对该区域里的血管管壁产生负荷加重的影响，不会使分流静脉床出现迂曲血液回流困难、继发扩张。即支架的后方连接长段的氟材料薄膜管的限流器，相当于在迂曲的静脉内增加一层氟材料薄膜，从而大大增加曲张静脉周围的组织支持度，并限制导引血液通过加固的通道进入体静脉从而减少静脉曲张破裂出血并保持人体自然建立的静脉分流通道，达到降低门静脉压力和增加曲张静脉壁的支持的双重作用，而当导流管的薄膜管伸展不佳时，可作为栓塞材料将迂曲之静脉栓塞阻断血流。
进一步地，金属丝线为外径0.10-0.15mm的镍钛丝；血液流入支架1由镍钛丝双向交叉螺旋缠绕而成，缠绕角度不做特别限定，但不能与血液流入支架1的径向平行和垂直。导流管2采用柔软度好、且可随血流方向与血管壁贴合的薄膜管制作而成，优选为ETFE薄膜管。
在血液流入支架1内侧还可包覆一层覆膜3，如图2所示，覆膜3为涂覆的医用硅胶或膜性材料并延伸到所述导流管，膜性材料可选择聚四氟乙烯、涤纶、聚脂、聚氨基甲酸乙酯中的一种，涂覆后形成一层薄膜，避免血液自缝隙漏出，对导流管血管壁造成冲击，使得血液流入支架和导流管与血管壁间产生间隙，减弱导流管对血管壁的支撑力。
导流管流出口内径也可以略窄于流入口内径，即导流管做成由粗至细的形状。
本发明还提供了一种治疗食管胃底静脉曲张及其破裂出血的血管内限流器制作方法，包括以下步骤：
S1、取外径为8mm的铜芯棒，并在铜芯棒上间隔设置两组沿其周向每隔45度设置的8个外径为0.5mm的小孔，每个小孔中***与小孔孔径相匹配的铜芯小棒，形成两组铜芯小棒；
S2、取一根外径为0.12mm镍钛丝按照预设的第一缠绕角度呈对角交替缠绕在两组铜芯小棒上，完成对两组所有铜芯小棒的缠绕，形成第一层缠绕网；
S3、按照预设的第二缠绕角度呈对角交替缠绕在两组铜芯小棒上，完成对两组所有铜芯小棒的缠绕，形成与第一层缠绕网交织设置的第二层缠绕网，缠绕后的第二层缠绕网与第一层缠绕网形成一个编织金属丝网；
S4、将步骤S3中编织好的编织金属丝网连同铜芯棒一起置入温度为350℃下热处理20min，得到预成型支架，如图3所示；
S5、取ETFE氟材料薄膜管一根，将其一端与所述步骤S4制得的预成型支架的端部采用热熔方法连接在一起，即可得到所需限流器。
S6、还可在步骤S4制备的限流器的血液流入支架内侧采用医用硅胶或膜性材料涂覆处理，制作成覆膜层，避免血液自支架缝隙漏出，对导流管血管壁造成冲击，使得血液流出支架、导流管外与血管壁间产生间隙，减弱导流管对血管壁的支撑力。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明的保护范围之中。
Claims (4)
1.治疗食管胃底静脉曲张及其破裂出血的血管内限流器，其特征在于，所述限流器包括血液流入支架(1)和导流管(2)，所述血液流入支架(1)由金属丝线螺旋缠绕而成，所述导流管(2)为薄膜管，所述血液流入支架(1)内径与所述导流管(2)内径一致，所述导流管流出口内径略窄于其流入口内径，使所述导流管做成由粗至细的形状，所述血液流入支架(1)与所述导流管(2)之间采用热熔固定连接；所述血液流入支架(1)内侧还可包覆一层覆膜(3)，所述覆膜(3)延伸到所述导流管(2)，所述覆膜为涂覆的医用硅胶或聚四氟乙烯、涤纶、聚脂、聚氨基甲酸乙酯中的一种膜性材料；所述金属丝线为外径0.10-0.15mm的镍钛丝；所述血液流入支架(1)由镍钛丝双向交叉螺旋缠绕而成；所述导流管(2)采用可随血流方向与血管壁贴合的薄膜管制作而成。
2.根据权利要求1所述的治疗食管胃底静脉曲张及其破裂出血的血管内限流器，其特征在于，所述导流管(2)为ETFE薄膜管。
3.一种如权利要求1所述的治疗食管胃底静脉曲张及其破裂出血的血管内限流器制作方法，其特征在于，所述制作方法包括以下步骤：
S1、取等径的铜芯棒，并在铜芯棒上间隔设置两组沿其周向设置的多个小孔，每个小孔中***与小孔孔径相匹配的铜芯小棒，形成两组铜芯小棒；
S2、取一根金属丝按照预设的第一缠绕角度呈对角交替缠绕在两组铜芯小棒上，完成对两组所有铜芯小棒的缠绕，形成第一层缠绕网；
S3、按照预设的第二缠绕角度呈对角交替缠绕在两组铜芯小棒上，完成对两组所有铜芯小棒的缠绕，形成与第一层缠绕网交织设置的第二层缠绕网，缠绕后的第二层缠绕网与第一层缠绕网形成一个编织金属丝网；
S4、将步骤S3中编织好的编织金属丝网连同铜芯棒一起置入温度为330-370℃下热处理15-30min，得到预成型支架；
S5、取薄膜管一根，将其一端与所述步骤S4制得的预成型支架的端部采用热熔方法连接在一起，即可得到所需限流器；
S6、将步骤S4制备的限流器的血液流入支架内侧采用医用硅胶或聚四氟乙烯、涤纶、聚脂、聚氨基甲酸乙酯中的一种膜性材料涂覆处理并延伸到导流管。
4.根据权利要求3所述的血管内限流器的制作方法，其特征在于，所述步骤S1中铜芯棒的外径为6-10mm，在铜芯棒上沿其周向每隔45度设置外径为0.3mm-0.7mm的小孔。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910765784.XA CN110604639B (zh) | 2019-08-19 | 2019-08-19 | 治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910765784.XA CN110604639B (zh) | 2019-08-19 | 2019-08-19 | 治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN110604639A CN110604639A (zh) | 2019-12-24 |
| CN110604639B true CN110604639B (zh) | 2024-03-15 |
Family
ID=68889902
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201910765784.XA Active CN110604639B (zh) | 2019-08-19 | 2019-08-19 | 治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法 |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN110604639B (zh) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113116614B (zh) * | 2019-12-30 | 2023-06-02 | 先健科技(深圳)有限公司 | 支架 |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1518518A2 (en) * | 2003-09-25 | 2005-03-30 | Karel Volenec | Stent designed to stop esophageal variceal bleeding |
| CN1836641A (zh) * | 2005-03-21 | 2006-09-27 | 太雄医疗器株式会社 | 食道支撑器 |
| CN211512203U (zh) * | 2019-08-19 | 2020-09-18 | 敖国昆 | 治疗食管胃底静脉曲张及其破裂出血的血管内限流器 |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6156064A (en) * | 1998-08-14 | 2000-12-05 | Schneider (Usa) Inc | Stent-graft-membrane and method of making the same |
| US6746489B2 (en) * | 1998-08-31 | 2004-06-08 | Wilson-Cook Medical Incorporated | Prosthesis having a sleeve valve |
| US7018401B1 (en) * | 1999-02-01 | 2006-03-28 | Board Of Regents, The University Of Texas System | Woven intravascular devices and methods for making the same and apparatus for delivery of the same |
| EP2094189A2 (en) * | 2006-12-12 | 2009-09-02 | Paul A. Spence | Implant, systems and methods for physically diverting material in blood flow away from the head |
-
2019
- 2019-08-19 CN CN201910765784.XA patent/CN110604639B/zh active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1518518A2 (en) * | 2003-09-25 | 2005-03-30 | Karel Volenec | Stent designed to stop esophageal variceal bleeding |
| CN1836641A (zh) * | 2005-03-21 | 2006-09-27 | 太雄医疗器株式会社 | 食道支撑器 |
| CN211512203U (zh) * | 2019-08-19 | 2020-09-18 | 敖国昆 | 治疗食管胃底静脉曲张及其破裂出血的血管内限流器 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN110604639A (zh) | 2019-12-24 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN211512203U (zh) | 治疗食管胃底静脉曲张及其破裂出血的血管内限流器 | |
| US7892254B2 (en) | Embolization method for endovascular occlusion | |
| CN107427377B (zh) | 支架 | |
| Choi et al. | Balloon-occluded retrograde transvenous obliteration for gastric variceal bleeding: its feasibility compared with transjugular intrahepatic portosystemic shunt | |
| JP4210602B2 (ja) | 血管内流量抑制装置 | |
| CN110604639B (zh) | 治疗食管胃底静脉曲张及其破裂出血的血管内限流器及其制作方法 | |
| CA2607516A1 (en) | Intravascular deliverable stent for reinforcement of vascular abnormalities | |
| JP2011514203A (ja) | 血管アクセスシステム | |
| CN201303993Y (zh) | 模块式主动脉腔内支架 | |
| KR20170056653A (ko) | 색전 장치 | |
| US11565082B2 (en) | Enhanced flexibility neurovascular catheter | |
| Nardelli et al. | Radiological intervention for shunt related encephalopathy | |
| CN205458867U (zh) | 一种用于颅内复杂动脉瘤的支架 | |
| US20210177430A1 (en) | Embolization catheter with integral filter | |
| CN200980741Y (zh) | 一种血管内阻塞装置 | |
| Sivakumaran et al. | An ilio-iliac arteriovenous fistula following spontaneous rupture of a right common iliac artery aneurysm | |
| Quaretti et al. | Dialysis catheter-related superior vena cava syndrome with patent vena cava: long term efficacy of unilateral Viatorr stent-graft avoiding catheter manipulation | |
| CN101642395A (zh) | 造口支架 | |
| Weening et al. | Chyluria and chylothorax after posterior selective fusion for adolescent idiopathic scoliosis | |
| CN110584734B (zh) | 治疗脾功能亢进症的血管内限流器及其制作方法 | |
| US12011186B2 (en) | Bevel tip expandable mouth catheter with reinforcing ring | |
| CN116211377A (zh) | 瘤内扰流装置 | |
| Giavroglou et al. | Idiopathic renal arteriovenous fistula treated by transcatheter embolization | |
| CN216318207U (zh) | 一种脾动脉内限流装置 | |
| Eleswarapu et al. | Hemorrhagic complications associated with percutaneous nephrolithotomy |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |