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CN102438558A - 支架 - Google Patents

支架 Download PDF

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Publication number
CN102438558A
CN102438558A CN2009801160541A CN200980116054A CN102438558A CN 102438558 A CN102438558 A CN 102438558A CN 2009801160541 A CN2009801160541 A CN 2009801160541A CN 200980116054 A CN200980116054 A CN 200980116054A CN 102438558 A CN102438558 A CN 102438558A
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Prior art keywords
support
bile
bile duct
stent
internal stent
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辛卿珉
权东日
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Taewoong Medical Co Ltd
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Taewoong Medical Co Ltd
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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
    • 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
    • A61F2/852—Two or more distinct overlapping 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
    • A61F2002/041—Bile ducts
    • 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
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2250/0014—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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  • 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)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

如果由于生长在胆管中的癌细胞或者胆管的狭窄导致胆汁向十二指肠的平滑运输的困难，圆柱形支架可植入胆管的狭窄位点以助于胆汁的平滑给供。传统支架不具有在其植入位点滑脱的风险，但是会经受入侵性生长的癌细胞。即使覆膜的支架具有被提议解决生长的癌细胞侵入的覆膜，覆膜支架可具有在其植入位点滑脱的风险，还可能导致胰腺炎和胆石病。为解决上述问题，在此披露了一种防止食物从十二指肠向胆管回流的支架，当确保胆汁的平滑运输时，没有由于运输胆汁导致的以外排泄的风险。该支架包括圆柱形外部支架；和向下逐渐变细的具有生物相容性的聚四氟乙烯（PTFE）或者硅材料涂覆的内部支架。内在和外部支架彼此相互连结形成双层结构。

Description

支架
技术领域
本发明涉及一种支架，尤其涉及一种具有双层结构的支架，其不受其在植入部位的滑脱和病变部位的侵入的影响，比如癌症肿瘤，和当其植入胆管内时，可防止回流，例如，食物从十二指肠向胆管回流。
背景技术
通常，为了防止大量的血管或机体器官的狭窄，或为解决食物、血液的运动或者多种酶导致的恶化，当例如癌性肿瘤生长在管状器官内阻塞或者使管状器官狭窄时，为了例如食物或血液的平滑运动，支架通常植入到阻塞的或狭窄的管状器官以强行扩张器官。
这样的支架主要由形状记忆合金制成，具有圆柱形形状。最近，具有不同形状的不同形状的支架已选择性得用于内部器官、血管等的不同的支架位点。
传统支架在其植入位点没有滑脱的风险，但是生长的肿瘤细胞会侵入到支架内部。即使支架上覆盖有用于解决生长的癌症细胞侵入的覆膜，覆膜支架具有在其植入位点滑脱的风险，从而导致胰腺炎和胆石病。
作为植入到机体器官内的支架的一个实施例，胆管是一个运输从肝脏到十二指肠的消化酶的通道。
若胆管由于癌性细胞生长到胆管内或胆管狭窄而在将胆汁从肝脏向十二指肠平滑运输上具有困难时，将圆柱形支架植入胆管内的狭窄位点使胆汁能够平滑地供给。
如前所述，当支架植入胆管内强行扩张胆管内部时，反而可能会阻止胆汁的供给，因为流经胃部的食物可能通过胆管内的支架回流到肝脏，而非通过十二指肠。
发明内容
技术问题
因此，本发明已考虑到上述问题，本发明的目的是提供具有双层结构的支架，其不受在其植入位点的滑脱和损伤部位的的侵入的影响，比如，癌症肿瘤，当确保胆汁的平滑运输不存在由运输胆汁引发的不理想的排出时，还可以防止食物从十二指肠向胆管回流。
技术解决方案
根据本发明的一个方面，上述的和其它的目标可通过提供一种如下的支架而实现，该支架包括圆柱形支架和插入到圆柱形支架内的向下逐渐变细的支架，所述向下逐渐变细的支架涂覆有具有生物相容性的聚四氟乙烯（PTFE）或硅材料，圆柱形支架和向下逐渐变细的支架相互嵌套形成双层结构。
如果需要，在外放置的支架还可能具有向下逐渐变细的形状，因此当支架植入到胆管内时，不会推向十二指肠。
有益效果
依照本发明，提供一种具有双层结构的支架的结果，放置在外侧的支架具有有效得保持支架于其所植入位点且不受滑脱的风险的效果，放置在外的覆膜支架具有阻止病变部位的侵入，比如防止癌症肿瘤的侵入的效果。
当支架插入到胆管中时，在外放置的具有圆柱型或向下逐渐变细的形状的支架，置于胆管内壁上，这样有助于扩张胆管；向内放置的支架具有向下逐渐变细的形状以防止例如食物从十二指肠通过胆管向肝脏的回流，确保胆汁的平滑运输。
附图说明
本发明的上述和其它的目的、特征和其它优点将从以下连结附图的详细描述中更清楚得理解，其中：
图1是根据本发明的实施例中的支架的分解透视图；
图2是根据本发明的外部支架和内部支架的连结实施例的部分剖面图；
图3是根据本发明的外部支架和内部支架的另一连结实施例的部分剖面图；
图4是根据本发明的支架的植入的参考图；
图5是本发明的另一个示例性实施例的示图。
附图编号说明
圆柱形外部支架：1              
PTFE或者硅材料覆膜：2
具有向下的逐渐变细的漏斗形内部支架：3。
具体实施方式
根据本发明的实施方式，支架包括外部支架1，其由形状记忆合金制成，具有圆柱形筛网形状；和内部支架3，其具有向下逐渐变细的漏斗形状，是由聚四氟乙烯(PTFE)或硅材料覆膜2覆盖。外部支架1和位于外部支架1内部的内部支架3相互连结形成一个双层结构。
以下，本发明连结附图详细描述。
图1是根据本发明的示例性实施例的支架的分解透视图，图2是根据本发明的外部支架和内部支架的连结实施例的部分剖面图，图3是根据本发明的外部支架和内部支架的另一个连结实施例的部分剖面图，图4是根据本发明的支架的植入的参考图，和图5是本发明另一个示例性实施例的示意图。
根据本发明的支架包括一个外部支架1，其具有圆柱形形状，由形状记忆合金制成；和一个内部支架3，其具有向下逐渐变细的漏斗形状，是由聚四氟乙烯（PTFE）或硅材料覆膜2覆盖。
本发明具有双层结构的支架5由内部支架3和外部支架1构成，所述内部支架3位于外部支架1内部且与外部支架连结。
在这一实施例中为了实现外部支架1和内部支架3的连结，所述外部支架1和所述内部支架3焊接形成W焊接点，或者使用形状记忆合金丝或线4彼些连接。
所述外部支架1，其作为根据本发明的支架的外部设置部分，具有筛网形状，一旦植入到器官中，通过例如血管造影术插入并被器官的内壁的部分区域卡住。以这种方式，本发明的支架不会有在其植入位点滑脱的风险。
另外，由于如上所述内部支架3由PTFE或硅材料覆膜2覆盖，内部支架3可防止病变部位的侵入，比如癌性肿瘤，即使病变部位的扩张发生在支架的植入之后。
以这种方式，本发明的支架不会有在其植入位点滑脱的风险，还可免于病变部位的侵入，例如癌性肿瘤，尽管病变部位扩张。
根据本发明的上述的支架5具有防止回流的效果。这将参考附图3中使用血管造影术为胆管A植入支架来进行描述。
所述外部支架1置于胆管A的内壁并扩张胆管A。所述内部支架3位于外部支架内部，具有向下逐渐变细的漏斗形状，由PTFE或者硅材料覆膜2覆盖，辅助在肝脏C中分泌的消化酶通过内部支架3平滑地向下从胆管A向十二指肠B运输。
即使例如在十二指肠B内的食物通过外部支架1返流回流到胆管A，所述内部支架3，其具有向下逐渐变细的漏斗形状，是由PTFE或者硅材料覆膜2覆盖，并置于外部支架1的内部以使内部支架3的上末端连接到外部支架1的内部位置上，此外，外部支架1进入紧密接触到胆管A的内壁，从而可以有效得防止例如，食物朝肝脏C返流回流。内部支架3，其低末端形成狭窄通道，进一步有效得防止其内食物的返流回流。
在本发明中，外部支架1插入到胆管A内部扩张胆管A。此时，考虑到外部支架1植入在胆管A内壁中的事实，外部支架1可具有逐渐变细的形状，以致于不会使肝脏C中分泌的消化酶推向十二指肠B。
进一步得，本发明中，由于内部支架3的上末端是连结到外部支架1，内部支架3的下末端通过例如经过十二指肠B的食物移动。这样内部支架3可以免于从十二指肠B的食物的回流。
即使内部支架3和外部支架1已描述成通过形状记忆合金丝或线4彼此联接，内部支架3和外部支架1的连结可根据场合需要通过焊接实施。
如上所述，由于筛网形状的外部支架可防止在其植入位点的支架的滑脱，内部支架名于任何病变部位，比如癌性肿瘤的侵入，本发明的支架是用于例如，器官或者血管。而且，归功于其抗回流功能，本发明的支架可杆入到任何存在回流风险的器官中，例如消化道，比如胆管。
可理解本发明的胆管应用仅是给出实施例的方式，不限定本发明的范围。 

Claims (5)

1.一种支架，其特征在于，包括：
一个由形状记忆合金制成并具有圆柱形筛网形状的外部支架；和
一个具有向下逐渐变细的漏斗形状的由聚四氟乙烯（PTFE）或者硅材料覆膜涂覆的内部支架，
其中外部支架和位于外部支架内部的内部支架相互连结形成双层结构。
2.根据权利要求1的支架，其特征在于，所述内部支架具有连结于外部支架的上末端。
3.根据权利要求1的支架，其特征在于，所述外部支架具有向下逐渐变细的形状。
4.根据权利要求1或2的支架，其特征在于，所述内部支架和外部支架的连结是由焊接实施的。
5.根据权利要求1或2的支架，其特征在于，所述内部支架和外部支架的连结是通过使用丝或线实施的。
CN2009801160541A 2009-07-10 2009-07-10 支架 Pending CN102438558A (zh)

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