CN108430387B - 具有外部支撑的支架移植物 - Google Patents
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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
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
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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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
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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
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
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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
- A61F2/06—Blood vessels
- A61F2002/068—Modifying the blood flow model, e.g. by diffuser or deflector
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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
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
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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
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0061—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof swellable
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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
- A61F2230/0065—Three-dimensional shapes toroidal, e.g. ring-shaped, doughnut-shaped
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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
- A61F2250/0014—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
- A61F2250/0051—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 tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
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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
- A61F2250/0014—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
- A61F2250/0056—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 wettability, e.g. in hydrophilic or hydrophobic behaviours
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
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- Heart & Thoracic Surgery (AREA)
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Abstract
一种支撑式支架移植物,包括具有内表面和外表面的移植物材料。所述内表面划定移植物材料内的腔体。所述支撑式支架移植物还包括支撑架,所述支撑架具有联接于移植物材料外表面的网状物。所述支撑架构造成促进组织在其中的长入。由此,所述支撑架增强组织向支撑式支架移植物内的整合。这种组织整合增强支撑式支架移植物在血管内的生物固定,最大程度降低内漏和移位的可能性。
Description
背景
技术领域
本申请涉及血管内装置和方法。更具体而言,本申请涉及用于治疗血管内疾病的装置。
背景技术
传统支架移植物一般具有由多个环形支架环构成的可径向扩张的加固结构和圆柱形的移植物材料层,所述移植物材料层形成腔体,支架环就联接于该腔体上。众所周知,支架移植物用于管形人体脉管内。
例如,动脉瘤腔内隔绝术是一种用支架移植物来消除动脉瘤内部流体压力的方法,其由此降低动脉瘤破裂的风险并减少侵入性手术干预。
传统支架移植物的移植物材料极度疏水,其所提供的环境不利于细胞的募集和增殖。由于组织无法整合到移植物材料内部,无法实现支架移植物在血管内的生物固定,导致支架移植物易发生内漏和移位。
发明概要
根据实施方式之一,支撑式支架移植物包括具有内表面和外表面的移植物材料。所述内表面划定移植物材料内的腔体。所述支撑式支架移植物还包括支撑架(scaffold),该支撑架具有与移植物材料外表面联接的网状物。
所述支撑架构造成促进组织向其中长入。由此,所述支撑架增强组织向支撑式支架移植物内的整合。所述组织整合增强支撑式支架移植物在血管内的生物固定,最大程度降低内漏和移位的可能性。
附图说明
图1是支撑式支架移植物实施方式之一的透视图。
图2是实施方式之一图1支撑式支架移植物的剖视图。
图3A是图2支撑式支架移植物区域III实施方式之一的放大图。
图3B是图2支撑式支架移植物区域III另一实施方式的放大图。
图4是脉管装配的剖视图,其中包括实施方式之一图1和图2所示支撑式支架移植物。
图5是支撑式支架移植物另一实施方式的透视画。
图6是实施方式之一图5支撑式支架移植物的剖视图。
图7是脉管装配的剖视图,其中包括实施方式之一图5和图6所示支撑式支架移植物。
图8是支撑式支架移植物另一实施方式的透视图。
图9是实施方式之一图8支撑式支架移植物的剖视图。
图10是脉管装配的剖视图,其中包括实施方式之一图8和图9所示支撑式支架移植物。
所有附图和说明书中同类元件统一编号。
详细描述
作为概述和实施方式之一,支撑式支架移植物包括移植物材料和外部支撑架。移植物材料提供组织整合屏障。外部支撑架则更适合促进组织整合,与移植物材料机械附连。组织进入外部支撑架形成与天然血管的生物固定,由此最大程度降低内漏和移位的可能性。
更具体而言,图1是作为实施方式之一的支撑式支架移植物100的透视图,这可以是例如腹主动脉支架移植物。如图1所示,支撑式支架移植物100 具有一个或多个支架环102。作为举例说明,支架环102是自扩张支架环,如镍钛合金(NiTi)的,有时称镍钛诺(Nitinol)。支架环102是可选的,实施方式之一不包括支架环102。
图2是实施方式之一的图1支撑式支架移植物100的剖视图。图2中,为清楚起见没有显示支架环102。
图1图2联合显示,支撑式支架移植物100具有移植物材料104和支撑架106。该实施方式中,移植物材料104具有位于移植物材料104近端110的近端开口108和位于移植物材料104远端114的远端开口112。
并且,支撑式支架移植物100具有长轴L。移植物材料104—总的来说是支撑式支架移植物100—划定腔体116。腔体116的延展大致与长轴L平行,其在支撑式支架移植物100的近端开口108和远端开口112之间延展。
本文中,假体(如支架移植物)的近端是经由血流路径最靠近心脏的末端,而远端则是展开时最远离心脏的末端。相反,需要注意的是,导管的远端通常指离操作者(手柄)最远的末端,而导管的近端则是离操作者(手柄)最近的末端。
清楚起见,本文中,导管的远端是离操作者最远的末端(离手柄最远的末端),而假体的远端是离操作者最近的末端(离手柄最近的末端),即,导管的远端和支架移植物的近端是离手柄最远的末端,而导管的近端和支架移植物的远端是离手柄最近的末端。然而,本领域技术人员能够理解,实际应用中,根据接入位置,支架移植物和递送系统的描述可以一致或者相反。
移植物材料104呈圆筒形,具有基本一致的直径D。然而,其他实施方式中,移植物材料104的直径会改变且/或在远端114分叉。移植物材料104具有圆筒形内表面118和相背的外表面120。
实施方式之一中,移植物材料104是疏水性的,例如是对苯二甲酸酯类聚酯(polyester terephthalate,PET)、膨胀对苯二甲酸酯类聚酯(ePET)或其他移植物材料。因为移植物材料104是疏水性的,移植物材料104提供了一个不利于细胞募集和增殖的环境。
实施方式之一中,为了加强组织整合,支撑架106通过附连装置/方式 122附连到移植物材料104的外表面120。作为举例说明,附连装置/方式122 是支撑架106与移植物材料104之间的缝合、粘合、热合或其他附连。
该实施方式中,支撑架106在移植物材料104的近端110处或其邻近附连于移植物材料104。移植物材料104的区域124被支撑架106覆盖,被称为移植物材料104的密封区124。移植物材料104的区域126不被支撑架106覆盖,被称为移植物材料104的裸露区126。密封区124从近端110向远端延展至裸露区126。裸露区126从密封区124向远端延展至远端114。
该实施方式中,支撑架106是网状物。实施方式之一中,网状物是划定其中多个开口128的交错或固体结构。例如,网状的线或丝交错(如编制)形成具有开口128的支撑架106。另一实施例中,管材或板材经激光切割在其中形成开口128,这样,支撑架106是一体的,即,是一个单件而不是多个部件组合而成。
实施方式之一中,对支撑架106中的开口128进行优化以促进最大程度的组织整合。实施方式之一中,开口128被支撑架106完全包围,即离散的开口。支撑架106有时亦称组织整合支撑架106。
实施方式之一中,支撑架106是金属材料的。例如,支撑架106由镍钛诺形成,但其他实施方式中也可由其他金属材料形成。另一实施方式中,支撑架106是聚合物材料的。总体来说,用来形成支撑架106的材料支持良好的组织向支撑式支架移植物100植入部位管壁内的整合和吸纳。
实施方式之一中,支撑架106物理联接移植物材料104,例如采用缝合技术联接。这样,支撑架106整合到血管壁中所带来的机械上的好处直接转化为支撑式支架移植物100增强抗移位和密封效果。
该实施方式中,支撑架106呈圆筒形。支撑架106是柔性的且足够低外形(lowprofile)以至于不会显著影响支撑式支架移植物100的组装密度。
图3A是图2支撑式支架移植物100区域III实施方式之一的放大图。如图3A所示,该实施方式中,支撑架106具有埋设于其中的组织反应增强纤维 330。例如,支撑架106具有支撑架本体332,例如由前文所述金属材料或聚合物材料的网状物形成,还有埋设在支撑架本体332内的组织反应增强纤维330。组织反应增强纤维330有时亦称生物活性材料纤维。
组织反应增强纤维330增强组织与支撑式支架移植物100的组织反应 (tissueresponse)。实施方式之一中,组织反应增强纤维330包含促进组织愈合的材料,有时亦称支撑材料。组织反应增强纤维330所含促进组织愈合的材料促进愈合进程,例如促进推动愈合进程的细胞募集或增殖。组织反应增强纤维 330所含促进组织愈合的材料的例子包括聚乙醇酸-乳酸(PGLA)、聚(甘油癸二酸酯)(PGS)、动物源性脱细胞骨架、胶原骨架和其他促进组织愈合的材料。
另一实施方式中,组织反应增强纤维330含有组织刺激性材料,所述组织刺激性材料主动促进引起强烈纤维细胞反应(fibrocellular response)的炎性反应。组织反应增强纤维330中刺激性材料的例子包括PGLA、聚乙醇酸(PGA)、聚乳酸(PLA)、丝、细菌内毒素及其他刺激性材料。
另一实施方式中,组织反应增强纤维330含有可吸收聚合物材料,所述可吸收聚合物材料允许促进快速愈合和/或促进血栓形成/熟化的生物活性分子的洗脱。生物活性分子的例子包括药物、肽、细胞因子/趋化因子。
图3B是图2支撑式支架移植物100区域III另一实施方式的放大图。如图3B所示,该实施方式中,支撑架106具有组织反应增强涂层334。例如,支撑架106包含支撑架本体332和涂在支撑架本体332之上或浸入其中的组织反应增强涂层334。组织反应增强涂层334增强组织与支撑式支架移植物100的组织反应,增强的方式与前文所述组织反应增强纤维330相似。组织反应增强涂层334有时亦称生物活性材料涂层。
更特别地,组织反应增强涂层334含有例如促进组织愈合的材料或刺激性材料等材料。实施方式之一中,组织反应增强涂层334含有促进组织愈合的材料用来促进组织愈合,如促进推动愈合进程的细胞募集或增殖。组织反应增强涂层334中促进组织愈合的材料的例子包括PGLA、PGS、动物源性脱细胞支撑架、明胶支撑架及其他促进组织愈合的材料。
另一实施方式中,组织反应增强涂层334含有组织刺激性材料,所述组织刺激性材料主动促进引起强烈纤维细胞反应的炎性反应。组织反应增强涂层 334中刺激性材料的例子包括PGLA、PGA、PLA、丝、细菌内毒素及其他刺激性材料。
另一实施方式中,组织反应增强涂层334含有可吸收聚合物材料,所述可吸收聚合物材料允许促进快速愈合和/或促进血栓形成/熟化的生物活性分子的洗脱。生物活性分子的例子包括药物、肽、细胞因子/趋化因子。
图4是脉管装配400的剖视图,其中包括实施方式之一图1和图2所示支撑式支架移植物100。如图4所示,血管402(如主动脉)有动脉瘤404。采用本领域技术人员熟知的众多技术中的任一种将支撑式支架移植物100部署在血管402内隔绝动脉瘤404。
从血管402分出的是第一支血管406和第二支血管408,有时亦称腹主动脉内脏分支。支血管406、408的位置在患者中因人而异。支血管的例子包括肾动脉(RA)和肠系膜上动脉(SMA)。
支撑式支架移植物100部署的位置正好在支血管406和408远端。支撑架106,即密封区124,部署在支血管406、408与动脉瘤404之间的停放区410。随时间推移,血管402的组织会与支撑架106整合,由此避免密封区124周围渗漏和支撑式支架移植物100移位。
停放区410有时亦称近端密封区410。虽然此处说的是近端密封区410,本领域技术人员根据本文可知,总体说来,支撑架106可以部署在任意密封区,例如包括远端密封区。
在血管402内锚定后,血液流动通过腔体116,更上位地说是通过支撑式支架移植物100,由此隔绝动脉瘤404。
图5是另一实施方式支撑式支架移植物500的透视图。图6是据实施方式之一图5所示支撑式支架移植物500的剖视图。图6中,清楚起见没有显示支架环102。图5和6所示支撑式支架移植物500与图1和2所示支撑式支架移植物100相似,仅有以下所述显著区别。
图5联合图6显示,支撑式支架移植物500具有移植物材料104、支撑架506和支撑架对抗支架环508。
实施方式之一中,为了增强组织整合,支撑架506由附连装置/方式122 附连到移植物材料104的外表面120。该实施方式中,支撑架506在移植物材料104的近端110处或其邻近附连于移植物材料104。移植物材料104的区域 124被支撑架506覆盖,同样称为移植物材料104的密封区124。移植物材料 104的区域126不被支撑架506覆盖,同样称为移植物材料104的裸露区126。
该实施方式中,形成支撑架506的材料与前文关于支撑架106所述的相同,包括金属材料、聚合物材料、组织反应增强纤维330、支撑架本体332、组织反应增强涂层334和/或以上任意组合。对支撑架506的金属与动脉之比进行优化以造成引起血栓形成的血液停滞从而有助于促进急性密封(acute seal)。实施方式之一中,支撑架506的金属:动脉比大于约30-40%,其他实施例可采用其他金属:动脉比。
该实施方式中,支撑架506呈圆环面(torus),例如形似面包圈。支撑架 506有时亦称管形网状物,例如,具有不会负面影响组装密度的薄柔性网状物。支撑架506包装在递送系统中时是扁平的,为的是降低对递送系统组装密度的影响,但在例如37℃会成形为管状。需要注意的是,在图5和图6中,支撑架506显示为展开形式,它在递送期间是塌缩状态的。
由于支撑架506展开成管形,支撑架506对移植物材料104施加向内的径向塌缩力。为了抵抗该力避免移植物材料104塌缩,将支撑架对抗支架环508,有时亦称支架移植物本体弹簧,联接在移植物材料104内表面118与支撑架506 直接相对的位置。支撑架对抗支架环508提供向外径向扩张力,该力大于支撑架506的向内径向塌缩力。因此,支撑架对抗支架环508避免了移植物材料104 因支撑架506而塌缩。实施方式之一中,由于支撑架506顺应血压的惯性,支撑架对抗支架环508可以软且薄。
虽然只显示了一个支撑架对抗支架环508,其他实施方式中,可以有一个以上支撑架对抗支架环508。并且,另一实施方式中,支撑架506施加于移植物材料104的向内径向塌缩力小于舒张压,例如,支撑架506具有“软”结构。该实施方式中,支撑架对抗支架环508不是必要的,其并不存在。几何设计是这样的:即便不存在支撑架对抗支架环508,支撑式支架移植物500也能随血流把持其形状。
实施方式之一中,支撑架506被充填或涂以湿胀材料510,如水凝胶。例如,湿胀材料510接触液体(如血液)时膨胀。湿胀材料510的膨胀进一步增强支撑式支架移植物500在血管内的密封,如以下结合图7所述。
图7是脉管装配700的剖视图,其中包括实施方式之一图5和图6所示支撑式支架移植物500。如图7所示,脉管装配700与图4脉管装配400相似,包括血管402、动脉瘤404和支血管406、408。采用本领域技术人员熟知的众多技术中的任一种将支撑式支架移植物500部署在血管402内隔绝动脉瘤404。
该实施方式中,动脉瘤404的颈710长度较短。颈710是动脉瘤404与支血管406、408之间的区域,有时亦称近端密封区710。作为举例说明,颈 710的长度为10mm或以下,因此有时亦称短颈710。如图7中所示,颈710 的直径随着远离支血管406、408而渐增。由于颈710的锥形形状,颈710有时亦称锥形颈710。
虽然图7所示和下文所述是锥形短颈710,本领域技术人员由本文可知,支撑式支架移植物500可以部署在任意血管中,与动脉瘤颈的长度和形状无关。并且,虽然此处说的是近端密封区710,本领域技术人员由本文可知,总体说来,支撑架506可以部署在任意密封区内,例如包括远端密封区。
如图7所示,支撑架506展开接触颈710的壁。支撑架506具有的径向力使得支撑架506令支撑式支架移植物500稳定在动脉瘤404空隙内。并且,支撑架506造成血液停滞,形成血栓促进支撑式支架移植物500对血管402的急性密封。支撑架506迅速整合到血管402的壁内,由此提供永久性的增强密封和抗移位。支撑架506特别适合固定在高角度颈区,例如颈710。
一旦在血管402内锚定,血液流动通过腔体116,更上位地说是通过支撑式支架移植物500,由此隔绝动脉瘤404。
如图7所示,另一实施方式中,支撑架506具有近端区段507,向近端方向从移植物材料104的近端110伸出并超过支血管406、408。该实施方式中,支撑架506具有充分的多孔性从而不会阻塞支血管406、408。
图8是另一实施方式支撑式支架移植物800的透视图。图9是实施方式之一图8所示支撑式支架移植物800的剖视图。图9中,清楚起见没有显示支架环102。图8和图9所示支撑式支架移植物800与图1和图2所示100相似,仅有以下所述显著区别。
图8联合9显示,支撑式支架移植物800具有移植物材料104、支撑架 806和支撑架对抗支架环808。
实施方式之一中,为了增强组织整合,支撑架806由附连装置/方式122 附连到移植物材料104的外表面120。该实施方式中,支撑架806附连于移植物材料104的全长,总体来说即近端110至远端114之间。
该实施方式中,形成支撑架806的材料与前文所述关于支撑架106的相同,包括金属材料、聚合物材料、组织反应增强纤维330、支撑架本体332、组织反应增强涂层334和/或以上任意组合。对支撑架806的金属与动脉之比进行优化以在动脉瘤囊中造成血液停滞形成血栓。实施方式之一中,支撑架806 的金属:动脉比大于约30-40%,其他实施例可采用其他金属:动脉比。
该实施方式中,支撑架806呈圆环状,例如形似面包圈。支撑架806有时亦称管形网状物。支撑架806在递送系统中包装时是扁平的,例如围绕移植物材料104缩折,为的是降低对递送系统组装密度的影响,但在例如37℃会成形为管状。需要注意的是,在图8和图9中,支撑架806显示为展开形式,它在递送期间是塌缩状态的。
由于支撑架806展开成管形,支撑架806对移植物材料104施加向内的径向塌缩力。为了抵抗该力并避免移植物材料104塌缩,将支撑架对抗支架环 808,有时亦称支架移植物本体弹簧,联接在移植物材料104内表面118,与支撑架806直接相对的位置。
据本实施方式,沿移植物材料104长度有多个支撑架对抗支架环808。支撑架对抗支架环808提供向外径向扩张力,该力大于支撑架806的向内径向塌缩力。因此,支撑架对抗支架环808避免了移植物材料104因支撑架806而塌缩。实施方式之一中,由于支撑架806顺应血压的惯性,支撑架对抗支架环 808可以软且薄。
并且,另一实施方式中,支撑架806施加于移植物材料104的向内径向塌缩力小于舒张压,例如,支撑架806具有“软”结构。该实施方式中,支撑架对抗支架环808不是必要的,其并不存在。几何设计是这样的:即便不存在支撑架对抗支架环808,支撑式支架移植物800也能随血流把持其形状。
实施方式之一中,支撑架806被充填或涂以湿胀材料810,如水凝胶。例如,湿胀材料810接触液体(如血液)时膨胀。湿胀材料810的膨胀进一步增强支撑式支架移植物800在血管内的密封,如以下结合图10所述。
该实施方式中,支撑式支架移植物800具有延伸部分814、816。延伸部分814、816从移植物材料104的远端114伸出。实施方式之一中,延伸部分 814、816是与移植物材料104相连的分开的部件(例如材质为移植物材料)。延伸部分814、816有时亦称模块化部件。另一实施方式中,延伸部分814、816 与移植物材料104整合,例如,单片移植物材料通过缝合或其他方式划分出延伸部分814、816。
延伸部分814、816将主腔体116分叉为腔体818、820。例如,将延伸部分814、816部署到髂动脉内。然而,另一实施方式中,支撑式支架移植物 800没有延伸部分814、816。并且,前文所述支撑式支架移植物100、500可具有其他实施方式中的延伸部分814、816。
图10是脉管装配1000的剖视图,其中包括实施方式之一图8和图9所述支撑式支架移植物800。如图10所示,脉管装配1000与图4所示脉管装配 400相似,包括血管402、动脉瘤404和支血管406、408。该实施方式中,脉管装配1000还包括远端髂动脉412、414。采用本领域技术人员熟知的众多技术中的任一种将支撑式支架移植物800部署在血管402内隔绝动脉瘤404。
该实施方式中,如图10所示,支撑架806部署成充填动脉瘤404的囊。由于部署在动脉瘤404内,支撑架806将支撑式支架移植物800锚定到位。这确保近端密封区410和远端密封区1012的密封,并防止模块化部件(如延伸部分814、816)脱位。
并且,支撑架806造成动脉瘤404内血液停滞形成血栓。动脉瘤404内的凝块形成最大程度减少I型和II型内漏的发生。并且,支撑架806迅速整合到血管402的壁内,提供永久性的增强密封和抗移位。
如支撑式支架移植物800左侧所示,实施方式之一中,动脉瘤404是不规则形状的,例如具有突出部分、动脉瘤404囊内的血栓和/或具有伸向它的一条或多条支血管1016。该实施方式中,支撑架806难以实际接触到血管,若非完全不可能。支撑架806造成血液停滞和血栓形成从而阻断支血管1016,由此阻止支血管1016向动脉瘤404充血,且避免与此相关的II型内漏。
虽然显示的是支血管1016,支血管1016代表的是构成II型内漏基础的所有交流。例如,当肠系膜下动脉(IMA)与腰动脉之间存在积极交流时,就会构成II型内漏的基础。这种交流会在整个管网中发生。支撑架806将囊中的血栓推出堵住该通路。一旦这种交流受限,血栓就会在囊血栓内的小腔内形成。实施方式之一中,支撑架806含有成血栓物质帮助囊内血栓形成。
在血管402内锚定后,血液流动通过腔体116,更上位地说是通过支撑式支架移植物800,由此隔绝动脉瘤404。该实施方式中,延伸部分814、816 被部署在髂动脉412、414内。
本文提供了示例性实施方式。这些示例性实施方式对范围不构成限制。有众多的变换形式,不论本文是否明示或暗示,例如材料和制造过程方面结构、维度、类型上的变换,是本领域技术人员根据本文教导能够实施的。
Claims (16)
1.一种支撑式支架移植物,其具有:
疏水性移植物材料,所述移植物材料具有内表面和外表面,所述内表面划定移植物材料内的腔体,所述移植物材料提供了不利于细胞募集和增殖的环境;和
支撑架,所述支撑架具有联接于所述移植物材料外表面的金属材料网状物,所述网状物中具有开口,所述支撑架构造成促进组织在其中的长入,所述支撑架所含金属与动脉之比经优化以在所述支撑架内造成引起血栓形成的血液停滞,且其中,所述网状物的形状为圆环面,所述支撑架具有埋设于其中的组织反应增强纤维。
2.如权利要求1所述的支撑式支架移植物,其中,所述移植物材料具有近端和远端,所述支撑架联接于所述移植物材料的近端。
3.如权利要求1所述的支撑式支架移植物,其还具有与支撑架联接的湿胀材料。
4.如权利要求1所述的支撑式支架移植物,其还具有于所述支撑架处与所述移植物材料联接的支架环,所述支架环构造成所提供的扩张力大于圆环面的压缩力。
5.如权利要求1所述的支撑式支架移植物,其中,所述支撑架含有与所述网状物联接的促进组织愈合的材料。
6.如权利要求1所述的支撑式支架移植物,其中,所述支撑架含有与所述网状物联接的组织刺激性材料。
7.如权利要求1所述的支撑式支架移植物,其中,所述金属材料含有镍钛合金。
8.如权利要求1所述的支撑式支架移植物,其中,所述支撑架包含成血栓物质。
9.如权利要求1所述的支撑式支架移植物,其中,所述支撑式支架移植物还包含所述支撑架与所述移植物材料之间的缝合。
10.一种支撑式支架移植物,其具有:
疏水性移植物材料,所述移植物材料具有近端和远端,所述移植物材料提供了不利于细胞募集和增殖的环境;和
支撑架,所述支撑架具有联接于所述移植物材料外表面的金属材料网状物,所述网状物内具有开口,所述支撑架基本上在所述移植物材料的近端和远端之间延伸,所述支撑架所含金属与动脉之比经优化以在所述支撑架内造成引起血栓形成的血液停滞,且其中,所述网状物的形状为圆环面,所述支撑架具有埋设于其中的组织反应增强纤维。
11.如权利要求10所述的支撑式支架移植物,其中,所述支撑架构造成充填动脉瘤囊。
12.如权利要求10所述的支撑式支架移植物,其中,所述网状物是管状的。
13.如权利要求10所述的支撑式支架移植物,其中,所述支撑架含有与所述网状物联接的促进组织愈合的材料。
14.如权利要求10所述的支撑式支架移植物,其中,所述支撑架含有与所述网状物联接的组织刺激性材料。
15.如权利要求10所述的支撑式支架移植物,其中,所述支撑架包含成血栓物质。
16.如权利要求10所述的支撑式支架移植物,其中,所述支撑式支架移植物还包含所述支撑架与所述移植物材料之间的缝合。
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-
2016
- 2016-02-12 US US15/043,246 patent/US10188500B2/en active Active
-
2017
- 2017-02-10 WO PCT/US2017/017327 patent/WO2017139545A1/en active Application Filing
- 2017-02-10 EP EP17706110.8A patent/EP3413837B1/en active Active
- 2017-02-10 CN CN201780004993.1A patent/CN108430387B/zh active Active
-
2018
- 2018-12-13 US US16/219,312 patent/US20190110884A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
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EP3413837B1 (en) | 2023-08-30 |
WO2017139545A1 (en) | 2017-08-17 |
US20190110884A1 (en) | 2019-04-18 |
EP3413837A1 (en) | 2018-12-19 |
US20170231749A1 (en) | 2017-08-17 |
US10188500B2 (en) | 2019-01-29 |
CN108430387A (zh) | 2018-08-21 |
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