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CN100362971C - 贲门支架 - Google Patents

贲门支架 Download PDF

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CN100362971C
CN100362971C CNB2005101011771A CN200510101177A CN100362971C CN 100362971 C CN100362971 C CN 100362971C CN B2005101011771 A CNB2005101011771 A CN B2005101011771A CN 200510101177 A CN200510101177 A CN 200510101177A CN 100362971 C CN100362971 C CN 100362971C
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cardia
positioning port
cardia stent
present
cydariform
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CN1765339A (zh
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程英升
周星
朱明�
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Priority to EP06817827A priority patent/EP1952785B1/en
Priority to AU2006314966A priority patent/AU2006314966B2/en
Priority to AT06817827T priority patent/ATE546108T1/de
Priority to PCT/CN2006/003078 priority patent/WO2007056946A1/zh
Priority to US12/084,470 priority patent/US20090138071A1/en
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    • A—HUMAN NECESSITIES
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    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2002/044—Oesophagi or esophagi or gullets
    • 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
    • A61F2230/0073—Quadric-shaped
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    • 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
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter

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Abstract

贲门支架，本发明之贲门支架由于采用了支撑网管配合上下定位口结构，定位好，不容易移位；特别是下端喇叭形定位口与支撑网管用医用柔性材料膜包覆，提高了贲门支架深入胃液部分支架的抗胃液的腐蚀能力；双层非重叠花瓣式防返流装置，有效提高了防返流，同时又保持了良好的通气能力；回收线的设置，方便支架位置的调整和支架取出。本发明之贲门支架具有不容易移位、适合贲门解剖学特点、防返流功能强、浸泡在胃液中的金属丝有保护涂层、手术操作简便的优点，适合于各种原因导致的贲门狭窄的扩张治疗。

Description

贲门支架
技术领域
本发明涉及一种医用内支架，特别是治疗食管贲门狭窄的贲门支架。
背景技术
现有技术中，食管贲门癌、贲门失缓症、食管裂孔疝，或其他物理或化学损伤导致的贲门狭窄，经手术治疗后经常发生贲门狭窄，采用朱明等人在中国专利ZL97200206.5中公开的一种带膜的医用腔内支架治疗这类狭窄时取得了一定的效果，但由于贲门形状特殊，上连食管下连胃，兼有防返流功能，植入的支架不仅要求定位好，不容易移位，而且支架的一部分会深入胃中，应避免裸露的金属丝在胃液中浸泡所导致的腐蚀断裂，因此需要对现有技术的支架进行改进，开发一种适合于治疗贲门狭窄使用的贲门支架。
发明内容
本发明旨在开发一种适合贲门狭窄使用的贲门支架，具有不容易移位、适合贲门解剖学特点、有防返流功能、浸泡在胃液中的金属丝有保护涂层。本发明的目的是这样来实现的：
贲门支架，包含如下结构特点：
a.所述贲门支架由钛镍形状记忆合金丝编织而成；
b.所述贲门支架上端有用钛镍形状记忆合金丝编织的鼓形定位口；
c.所述贲门支架下端有用钛镍形状记忆合金丝编织的喇叭形定位口；
d.所述贲门支架上端鼓形定位口与下端喇叭形定位口通过能抵抗贲门狭窄收缩力的用钛镍形状记忆合金丝编织的支撑网管相连接；
e.所述贲门支架除了鼓形定位口外其他部分被可在人体中植入的医用柔性材料膜包覆；
f.所述贲门支架至少包含一个防返流瓣，防返流瓣是用可在人体中植入的医用柔性材料膜制造的向下端凸起的三瓣形花瓣结构，位于下端喇叭形定位口与支撑网管的连接部，或者上端鼓形定位口与支撑网管的连接部，或者支撑网管的内部。
——上述可在人体中植入的医用柔性材料是指医用硅胶、医用聚氨酯、医用聚四氟乙烯。
——上述贲门支架有二个防返流瓣，二个防返流瓣的瓣与瓣之间的裂缝的垂直投影不重合，形成双层防返流贲门支架，这种结构在保持通气性能好的情况下，可以有效提高防返流效果。
——上述贲门支架上端鼓形定位口上安装有能使鼓形定位口向心收缩的回收线，当临床需要时可以拉动回收线，使鼓形定位口向心收缩，进而带动整个贲门支架向心收缩，方便在必要时调整贲门支架的位置或将整个支架取出体外。
本发明之贲门支架由于采用了支撑网管配合上下定位口结构，定位好，不容易移位；特别是下端喇叭形定位口与支撑网管用医用柔性材料膜包覆，提高了贲门支架深入胃液部分支架的抗胃液的腐蚀能力；双层非重叠花瓣式防返流装置，有效提高了防返流，同时又保持了良好的通气能力；回收线的设置，方便支架位置的调整和支架取出。本发明之贲门支架具有不容易移位、适合贲门解剖学特点、防返流功能强、浸泡在胃液中的金属丝有保护涂层、手术操作简便的优点，适合于各种原因导致的贲门狭窄的扩张治疗。
附图说明
图1是本发明之单层防返流贲门支架的结构示意图。
图2是图1的立体结构示意图。
图3是本发明之双层防返流贲门支架的结构示意图。
图4是图3的立体结构示意图。
图5是图3的双层防返流瓣的瓣与瓣之间的裂缝的垂直投影示意图。
图6本发明之带回收线的单层防返流贲门支架的结构示意图。
图7是图6的立体结构示意图。
图8是本发明之带回收线的双层防返流贲门支架的结构示意图。
图9是图8的立体结构示意图。
图10是本发明之贲门支架的工作原理图。
上述图中：1为鼓形定位口，2为喇叭形定位口，3为支撑网管，4为可在人体中植入的医用柔性材料膜，5为防返流瓣，6为回收线，7为防返流瓣的瓣与瓣之间的裂缝，8为钛镍形状记忆合金丝，9为食管，10为胃，11为本发明之贲门支架。
具体实施例
实施例1：单层防返流贲门支架的制造
选用恢复温度为25℃～33℃直径为0.2mm～0.25mm的医用级钛镍形状记忆合金丝8在模具中编织成上端为鼓形1、下端为喇叭形2、中间为圆柱管形3的丝网，然后在模具中进行定型热处理，使定型热处理后的钛镍形状记忆合金丝网在恢复温度以上(如35℃～37℃时)上端为鼓形1、下端为喇叭形2、中间为圆柱管形3。在专用模具中用医用级硅胶4包覆这种丝网除了上端鼓形1外的其他部分，同时在下端喇叭形2与中间圆柱网管3的连接部制造向下凸起的半圆球形硅胶薄膜，将半圆球形硅胶薄膜剪成均匀的三部分，形成防返流瓣5，清洗后即得到了本发明之单层防返流贲门支架，参考图1、图2。
实施例2：双层防返流贲门支架的制造
基本制造方法与实施例1相同，仅在最后一道覆膜工艺时所用的模具不同，在下端喇叭形定位口2与中间圆柱网管3的连接部，以及上端鼓形定位口1与中间圆柱网管3的连接部分别形成两层防返流瓣5，即得到了本发明之双层防返流贲门支架，参考图3、图4、图5。
实施例3：带回收线的单层防返流贲门支架的制造
基本制造方法与实施例1相同，不同之处在于制造好单层防返流贲门支架后，在未覆膜的鼓形定位口1的上端的边缘上用医用手术缝合线(即回收线6)穿在钛镍形状记忆合金丝8形成的网孔中，即得到了本发明之带回收线的单层防返流贲门支架。当拉紧回收线6时，使鼓形定位口1向心收缩，进而带动整个贲门支架向心收缩，方便在必要时调整贲门支架的位置或将整个支架取出体外，参考图6、图7。
实施例4：带回收线的双层防返流贲门支架的制造
基本制造方法与实施例2或3相同，与实施例3不同之处在于多制造了一层防返流瓣。参考图8、图9。
此外，医用柔性材料膜4还可以选用其他可在人体中植入的医用柔性材料，如医用硅胶、医用聚氨酯、医用聚四氟乙烯、医用聚丙烯等；医用级钛镍形状记忆合金丝的直径大小及恢复温度的高低、防返流瓣的厚度、防返流瓣位置等也可以依据临床的实际情况做相应调整。
临床植入时，将本发明之贲门支架11压缩在专用的输送器中，在胃镜的直视下或者X射线的监视下，将本发明之贲门支架11释放在贲门狭窄处，使贲门支架的上端的鼓形定位口1位于贲门上的食管9内，贲门支架的下端喇叭形定位口2位于贲门下的胃10内，紧贴胃壁。防返流瓣5起到防止和减少胃酸返流的作用，回收线6方便在必要时调整贲门支架的位置或将整个支架取出体外，参考图10。
应该注意，本文中公开和说明的结构可以用其它效果相同的结构代替，同时本发明所介绍的实施例并非实现本发明的唯一结构。虽然本发明的优先实施例已在本文中予以介绍和说明，但本领域内的技术人员都清楚知道这些实施例不过是举例说明而已，本领域内的技术人员可以做出无数的变化、改进和代替，而不会脱离本发明，因此，应按照本发明所附的权利要求书的精神和范围来的限定本发明的保护范围。

Claims (4)

1.贲门支架，其特征在于：
a.所述贲门支架由钛镍形状记忆合金丝(8)编织而成；
b.所述贲门支架上端有用钛镍形状记忆合金丝编织的鼓形定位口(1)；
c.所述贲门支架下端有用钛镍形状记忆合金丝编织的喇叭形定位口(2)；
d.所述贲门支架上端鼓形定位口(1)与下端喇叭形定位口(2)通过能抵抗贲门狭窄收缩力的用钛镍形状记忆合金丝编织的支撑网管(3)相连接；
e.所述贲门支架除了鼓形定位口(1)外其他部分被可在人体中植入的医用柔性材料膜(4)包覆；
f.所述贲门支架至少包含一个防返流瓣(5)，防返流瓣(5)是用可在人体中植入的医用柔性材料膜制造的向下端凸起的三瓣形花瓣结构，位于下端喇叭形定位口(2)与支撑网管(3)的连接部，或者上端鼓形定位口(1)与支撑网管(3)的连接部，或者支撑网管(3)的内部。
2.根据权利要求1所述的贲门支架，其特征在于所述可在人体中植入的医用柔性材料是指医用硅胶或医用聚氨酯或医用聚四氟乙烯。
3.根据权利要求1所述的贲门支架，其特征在于所述贲门支架有二个防返流瓣(5)，二个防返流瓣的瓣与瓣之间的裂缝(7)的垂直投影不重合。
4.根据权利要求1或3所述的贲门支架，其特征在于所述贲门支架上端鼓形定位口(1)上安装有能使鼓形定位口(1)向心收缩的回收线(6)。
CNB2005101011771A 2005-11-16 2005-11-16 贲门支架 Expired - Fee Related CN100362971C (zh)

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AU2006314966A AU2006314966B2 (en) 2005-11-16 2006-11-16 A cardia stent
AT06817827T ATE546108T1 (de) 2005-11-16 2006-11-16 Kardia-stent
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EP1952785A4 (en) 2010-11-17
US20090138071A1 (en) 2009-05-28
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ATE546108T1 (de) 2012-03-15
EP1952785A1 (en) 2008-08-06

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