CN101442958B - 心脏瓣膜替换设备 - 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
- A61F2/24—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
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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
- A61F2/24—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
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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
- A61F2/24—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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
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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
- A61F2/24—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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
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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
- A61F2230/0069—Three-dimensional shapes cylindrical
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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
- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
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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
- A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
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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
- A61F2250/0039—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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- 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
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
Abstract
一种放置瓣膜于管状器官内的方法,该方法包括输送可扩张管状适配器至管状器官内的期望部位,其中适配器包括由与内壁隔开的外壁环绕的封闭容积以及第一端壁和第二端壁。该方法还包括相对于内壁扩张外壁使得外壁接触管状器官并放置瓣膜于适配器的内壁内。该方法还包括置入材料于适配器的封闭容积内以相对于内壁扩张外壁,其中材料可包括液体或凝胶。或者,瓣膜可在适配器输送至期望部位前置于内壁内。
Description
技术领域
本发明一般地涉及心脏瓣膜疾病的治疗,并且更具体地,涉及机能失常肺动脉瓣膜的替换。
背景技术
近年来,人们越来越关注心脏瓣膜的微创和经皮替换。在肺动脉瓣膜替换这一具体情况下,由Tower等人提交且全文结合于此以供参考的美国专利申请公开No.2003/0199971 A1和No.2003/0199963 A1说明了安装于可伸缩支架内用作替换肺动脉瓣膜的带瓣牛颈静脉段。该替换瓣膜安装于球囊导管中并经血管系统经皮送至失常肺动脉瓣膜位置,并由球囊扩张以压缩自体瓣膜小叶抵住右心室流出道,锚定并密封替换瓣膜。如论文《肺动脉瓣膜的经皮置入》(Percutaneous Insertion of the Pulmonary Valve),Bonhoeffer等人,《美国心脏病学会杂志》(Journal of the American College of Cardiology)2002;39:1664-1669和《牛肺动脉瓣膜的经导管替换》(Transcatheter Replacementof a Bovine Valve in Pulmonary Position),Bonhoeffer等人,《循环》(Circulation)2000;102:813-816所述,其全文结合于此以供参考,可植入替换肺动脉瓣膜以替换位于带瓣导管内的自体肺动脉瓣膜或人工肺动脉瓣膜。说明经皮瓣膜移植特点的其它论文包括Louise Coats等人的《经皮肺动脉瓣膜支架移植对右心室流出道再次介入的潜在影响》(The Potential Impactof Percutaneous Pulmonary Valve Stent Implantation on Right VentricularOutflow Tract Re-Intervention),《欧洲心胸外科杂志(英国)》(EuropeanJournal of Cardio-Thoracic Surgery(England)),2005年4月,第536-43页;Peter C.Block等人的《心脏瓣膜疾病的经皮研究法》(PercutaneousApproaches to Valvular Heard Disease),《最新心脏学报告(美国)》(CurrentCardiology Reports(United States)),2005年3月,第108-13页;GeorgLutter等人的《经皮瓣膜替换:最新状况和未来展望》(Percutaneous ValveReplacement:Current State and Future Prospects),《胸外科纪事(荷兰)》(Annals of Thoracic Surgery(Netherlands)),2004年12月,第2199-206页;Younes Boudjemline等人,《较大右心室流出道内的经皮肺动脉瓣膜替换:实验研究》(Percutaneous Pulmonary Valve Replacement in a Large RightVentricular Outflow Tract:An Experimental Study),《美国心脏病学会杂志(美国)》(Journal of the American College of Cardiology(UnitedStates)),2004年3月17日,第1082-7页;S.Khambadkone等人,《肺动脉瓣膜的经皮移植》(Percutaneous Implantation of Pulmonary Valyes),《心血管病治疗专家评论(英国)》(Expert Review of Cardiovascular Therapy(England)),2003年11月,第541-18页;Y.Boudjemline等人,《经皮瓣膜置入:一种新方法》(Percutaneous Valve Insertion:A New Approach),《胸和心血管外科杂志(美国)》(Journal of Thoracic and CardiovascularSurgery(United States)),2003年3月,第741-2页;Philipp Bonhoeffer等人,《肺动脉瓣膜的经皮置入》(Percutaneous Insertion of the PulmonaryValye),《美国心脏病学会杂志(美国)》(Journal of the American Collegeof Cardiology(United States)),2002年5月15日,第1664-9页;YounesBoudjemline等人,《走近经皮主动脉瓣膜替换》(Steps Toward PercutaneousAortic Valve Replacement),《循环(美国)》(Circulation(United States)),2002年2月12日,第775-8页;P.Bonhoeffer等人,《瓣膜机能失常的右心室至肺动脉人工导管内肺动脉瓣膜的经皮替换》(PercutaneousReplacement of Pulmonary Valve in a Right-Ventricle to Pulmonary-ArteryProsthetic Conduit with Valve Dysfunction),《柳叶刀(英国)》(Lancet(England)),2000年10月21日,第1403-5页;P.Bonhoeffer等人,《牛肺动脉瓣膜的经导管移植:羊羔实验》(Transcatheter Implantation of aBovine Valve in Pulmonary Position:A Lamb Study),《循环(美国)》(Circulation(United States)),2000年8月15日,第813-6页;G.O.Yonga等人,《经皮球囊二尖瓣分离术对重度二尖瓣狭窄的肺静脉血流的影响》(Effect of Percutaneous Balloon Mitral Valvotomy on Pulmonary VenousFlow in Severe Mitral Stenosis),《东非医学杂志(肯尼亚)》(East AfricanMedical Journal(Kenya)),1999年1月,第28-30页;以及G.O.Yonga等人,《肺动脉瓣膜狭窄的经皮腔内球囊瓣膜成形术:六个病例报告》(Percutaneous Transluminal Balloon Valvuloplasty for Pulmonary ValveStenosis:Report on Six Cases),《东非医学杂志(肯尼亚)》(East AfricanMedical Journal(Kenya)),1994年4月,第232-5页,其全文均结合于此以供参考。
尽管上述专利申请及论文所述的肺动脉瓣膜替换方法似乎是可行的治疗方法,但因可用的带瓣牛颈静脉段的尺寸范围相对较窄,一般仅可用至约22mm的直径,因此并非所有可受益的人均可用。不幸的是,需要肺动脉瓣膜替换的最常见的病人群体为婴儿时期已接受过法洛四联症跨环补片(transannularpatch repair of tetralogy of Fallot)的成年人和儿童,从而使得他们的右心室流出道的直径大于22mm。因此,一般的静脉段通常不能安全植入这些病人体内。
图1示出了已开发的允许带瓣牛颈静脉段用于右心室流出道较大的病人的现有技术的适配器支架10的一个示例。支架10包括由镍钛诺金属丝制成的丝网支架,该丝网支架经常规技术热处理以记忆其所示结构。在所示的示例中,适配器支架10基本为确定内腔的圆柱形丝结构。适配器支架10基本具有圆柱形近端部分12和远端部分14,各自直径足够大以接触其将被植入的流出道内部。该近端部分12和远端部分14朝向其中可安装带瓣静脉段或其它替换瓣膜的直径减小的基本圆柱形中部16逐渐缩小。
图2是图1所示适配器支架10的端视图,包括具有多个小叶20的带瓣静脉段18。静脉段18沿支架近端边缘和远端边缘缝合至适配器支架10,也可最大程度缝合于支架,如果并非覆盖静脉段的全部支架金属丝交叉处。附加缝合已说明为用于瓣膜结合处之间的区域。适当的瓣膜部件的组装的一个示例见受让人同时待决的以Philippe Bonhoeffer和Debra Ann Taitague等人名义于2005年11月18日提交并指定为美国第11/282,275号的美国专利申请《心脏瓣膜治疗设备及其制造方法》(Apparatus for Treatment of Cardiac Valvesand Method of Its Manufacture)。
图3是图1所示类型的植入右心室流出道40的替换瓣膜的示意性横截面图。如图所示,适配器支架10的近端部分12和远端部分14的位置使得较大直径部分接触流出道40的内壁。适配器支架10可推开自体瓣膜小叶42,这允许带瓣静脉段18的小叶20植入自体瓣膜的原始位置。适配器支架10的位置也可使得近端段压缩自体小叶抵住流出道壁或也可定位于自体小叶42的下游。
但是,仍需要提供各种装置以适合不同病人,也需要改进移植直径相对较小的瓣膜段于直径相对较大的病人区域内可用的装置。
发明内容
本发明一般是要提供允许在替换瓣膜期望位置直径大于可用替换瓣膜直径的位置使用替换瓣膜的机构。更具体地,本发明是要提供允许带瓣静脉段(如牛颈静脉)用作具有较大右心室流出道的病人体内的替换肺动脉瓣膜的机构。但是,本发明也可与例如授权给Cox的美国专利No.6,719,789和No.5,480,424公开的其它替换瓣膜或例如包括心包组织、镍钛诺金属和/或聚合体的其它瓣膜结合使用。可进一步设想猪或马静脉段可与本发明的装置结合使用。
本发明通过提供可扩张适配器支架实现上述目标,该可扩张适配器支架的结构为扩张时具有基本圆柱形外壁且该外壁直径大至足以接合并密封期望移植部位处的脉管内壁。适配器支架进一步包括内部,该内部基本为圆柱形且直径小于适配器支架外壁的直径。该内部的壁沿适配器支架长度延伸,且该内部的壁的内直径基本等于定位其中或将定位其中的带瓣静脉段或其它替换瓣膜的外直径。
在本发明的第一结构中,带瓣静脉段或其它替换瓣膜在移植前定位于适配器支架的内部。在第二结构中,带瓣静脉段或其它替换瓣膜在适配器支架先植入后置于适配器支架的内部中。在此实施例中,替换瓣膜可自身安装于可扩张瓣膜支架内,如以上所引用的Tower等人的应用和Bonhoeffer等人的论文中所述。本发明所使用的支架可为如由镍钛诺金属制成的自扩张支架类型或可为通过例如球囊等装置可扩张的支架。在下述优选实施例中,本发明的适配器支架提供为由具有内部空间以在延长期间封入液体或凝胶材料物质的液体不渗透外结构组成的管状结构。这样,所有血流将引导通过其中定位替换瓣膜的适配器支架的内部。
在本发明的一方面中,提供了一种放置瓣膜于直径大于瓣膜直径的管状器官内的方法。该方法包括输送可扩张管状适配器至管状器官内的期望部位,其中适配器包括由具第一直径的圆柱形外壁环绕的封闭容积,圆柱形外壁与具有小于第一直径的第二直径的圆柱形内壁同心隔开,第一端壁和第二端壁分别延伸于圆柱形外壁和圆柱形内壁之间的适配器近端和远端处。该方法还包括相对圆柱形内壁扩张圆柱形外壁使得圆柱形外壁接触管状器官,并放置瓣膜于适配器的圆柱形内壁内。该方法还包括置入材料于适配器的封闭容积内以相对于内壁扩张外壁,其材料可包括例如液体或凝胶且可为完全或部分硬化的材料。可替换地,瓣膜可在适配器被输送至期望部位前定位于圆柱形内壁内。
在本发明的另一方面中,提供了一种放置瓣膜于直径大于瓣膜直径的管状器官内的设备。该设备包括由具有第一直径的圆柱形外壁环绕的封闭容积,圆柱形外壁与具有小于第一直径的第二直径的圆柱形内壁同心隔开,且第一端壁和第二端壁分别延伸于圆柱形外壁和圆柱形内壁之间的适配器近端和远端处。所述设备还包括封闭容积内包含的一定量的材料和安装于适配器的圆柱形内壁内的瓣膜。外壁、内壁或外壁和内壁可包括伸出表面的至少一个凸起,以与至少一部分瓣膜配合。
附图说明
现将参照附图进一步说明本发明,其中贯穿几个附图的相同结构由相同数字表示,且其中:
图1是示例性现有技术的适配器支架的侧视图;
图2是图1所示的适配器支架的示意性端视图,其中安装有带瓣静脉段;
图3是植入右心室流出道内的图1所示类型的替换瓣膜的横截面侧视图;
图4是根据本发明的适配器支架的实施例的透视图;
图5是图4所示的适配器支架的横截面侧视图;
图6是如以上引用的Tower等人和Bonhoeffer等人的参考文献中所述的带支架带瓣静脉段的侧视图;
图7是根据本发明输送带瓣静脉段的输送系统的侧视图;
图8是由图7所示系统输送的图6所示的带瓣静脉段的侧视图;
图9是植入右心室流出道内的定位于本发明的适配器支架内的替换瓣膜的横截面侧视图;
图10是根据本发明的适配器支架的输送系统的侧视图;
图11是适配器支架另一实施例的局部横截面图,该适配器支架包括从适配器支架外表面向外伸出的梁或凸起;
图12是适配器支架另一实施例的局部横截面图,该适配器支架包括向内伸向适配器支架内开放通道的梁或凸起;
图13是根据本发明的适配器支架的另一实施例的横截面图,该适配器支架包括位于其中的瓣膜段;
图14是根据本发明另一实施例的连接到支架的瓣膜的示意性透视图;
图15是本发明适配器支架的另一实施例的横截面侧视图,该适配器支架包括处于第一位置的图14所示的瓣膜和支架;以及
图16是图15所示适配器支架的横截面侧视图,该适配器支架包括处于第二位置的图14所示的瓣膜和支架。
具体实施方式
现参照附图,其中相同部件以相同数字标注,且首先参照图4和5,示出了根据本发明的适配器支架200的示例性结构。适配器支架200可用于将漏斗状器官或右心室流出道减小为适合经皮肺动脉瓣膜的直径。即,适配器支架200提供了尺寸或直径适当的区域以接受瓣膜置入,如在漏斗状器官或右心室流出道过大从而不适于该瓣膜的区域内。适配器支架200包括基本圆柱形球囊202,该基本圆柱形球囊202环绕基本延伸经过其中心的内通道204。由球囊202的内壁206确定的该内通道204相对于球囊202的外表面208而基本同心定位,尽管可能至少稍有偏移。端壁210和212延伸于内壁206和外表面208之间,从而为球囊202提供封闭的管状结构。端壁210和212可基本笔直或平坦并沿基本垂直方向从内壁206和外表面208中的一者或两者朝向内壁206和208中的另一者延伸。可替换地,端壁210和212也可为提供内壁206和外表面208之间的平滑过渡表面的球囊的基本凹入或凸起部分。
如下进一步的描述,球囊202可以基本紧缩或折叠状态置入病人体内,之后顺序填充多种物质之一或更多。例如,这些物质可为不硬化类型,如空气或粘度不同的液体。在此情况下,球囊可被提供有保持球囊内包含的材料(即避免泄漏)的机构,如塞子或其它闭合机构。也可设想球囊自身由自密封类型材料构造,该自密封类型材料可穿孔或另行破损以允许通过喷嘴或其它装置填充球囊,并且该自密封类型材料在球囊填充装置被去除后将自行再次密封。可替换地,球囊可填充化合物,该化合物可完全或部分硬化从而使该化合物一旦被硬化则不能从球囊泄漏或转移。该可硬化材料可在其注入或置入球囊内后在其中快速或即时硬化,或该材料可在一段时间内逐渐硬化,如响应周围体液和组织的温度。可用于球囊内的其它示例性材料包括以下各项:盐水、胶原质、硅酮、水凝胶、血液、泡沫、由玻璃制成的小珠或小球、聚合体或金属等。
尽管以上说明球囊和/或适配器支架为基本圆柱形形状,则可以理解球囊也可以本发明范围内的多种方式成形。例如,球囊可具有例如基本为椭圆形、卵形、球形或不规则形状的外壁,且该球囊的内壁的形状可与外壁的形状相同或不同。在任一情况下,内壁被构造为容纳瓣膜,且外壁被构在为可使其面积的充分大的部分稳固接触其置入的身体开口。即,球囊的外壁可具有例如适合右心室流出道的先天不规则所必需的多种不规则形状的轮廓。在此方面,球囊和/或适配器支架可具有处于折叠或半折叠状态时基本为圆柱形的外壁,但该球囊和/或适配器支架相对一致从而使其外壁在适当身体开口内扩张时相对不规则。因此,本发明的适配器支架可用于体内不包括规则形状管状开口的区域。另外,对于任何球囊和/或适配器支架,内通道相对球囊的外表面可稍有偏移或严重偏移(即不同心)。
球囊202可由与其内含材料相容且优选为体液不可渗透的任何材料制成。在本发明的任一实施例中,球囊可由一种或多种材料形成,该材料形成可在延长期间内保持球囊扩张状态的连续管道。即,一旦球囊已密封,则球囊内部区域内放置的材料应不能转移或泄漏,且球囊外的流体应不能移入球囊的内部区域。换句话说,制成球囊的材料应不能渗透其接触的任何流体。示例性球囊材料包括PTFE(聚四氟乙烯)或ePTFE(膨体聚四氟乙烯),但也可使用大范围的不可渗透材料或材料组合。还可设想球囊表面可包括有助于组织内生或血管翳的材料,如具有生物相容和生物稳定涂层的织物或其它材料和/或有助于置入位置中的球囊修复的表面结构。这种材料可构成整个球囊,或仅部分球囊可包括有助于组织内生的材料。
在本发明的一个结构中,构成球囊202的材料足够柔软以适合多种组织从而使一特定尺寸和形状的适配器支架200可被构造为用于多种病人体内。另外,球囊202期望被设计为提供膨胀时不论内壁206和外表面208相隔距离多远均具有预定尺寸的内通道204。即,如果球囊202将扩张以适合异常大的组织,则内通道204可保持预定直径以接受瓣膜处于其适当方位。因此,球囊202可由单个材料构成或由在球囊特定区域内的厚度或其它属性中变化以允许获得期望扩张轮廓的材料、部分和/或部件的组合构成。例如,与组成外表面208的球囊部分相比,组成内壁206的球囊202部分可相对不可变形或不可扩张,使得添加材料至球囊202的内部区域将不允许球囊202扩张至内通道204内,而仅允许球囊202的外表面208扩张至远离内壁206。这样,内通道204的直径可保持为接受替换瓣膜的特定尺寸。另外,端壁210和端壁212之间的距离优选为在球囊202折叠或球囊202部分或完全扩张时近似相等。但是,球囊202的长度也可在材料置入其中时至少稍稍增大。
本发明的球囊的扩张可包括制成球囊的材料响应于添加材料至球囊内部容积的实际拉伸或扩张。但在其它实施例中,材料自身实际不扩张或拉伸,而球囊内部容积的填充使得球囊壁相互远离,从而扩大内部球囊容积。
球囊202可由一种或多种物质覆盖或部分覆盖以控制或避免瓣膜内生并密封,如涤纶、PTFE、组织等。制成球囊的材料可包括初次使用时基本无空隙但允许植入前短期有限泄漏的材料。这种类型的材料在植入时变得不可渗透。金属支架材料也可与球囊材料结合使用以允许球囊202的特制径向力。另外,球囊可包括例如环、倒刺、钩、齿或伸出或伸入内壁球囊材料、外壁球囊材料或内壁和外壁球囊材料内的其它凸起或凹陷。该结构的一个示例见图11中所示的适配器支架250。适配器支架250包括基本圆柱形球囊252,该基本圆柱形球囊252环绕基本延伸穿过该基本圆柱形球囊252中心的内通道254。球囊252包括定义了内通道254的内壁256,其中内通道254具有在其长度上基本恒定的直径。球囊252还包括与内壁256隔开的外壁258。至少一个凸起260从外壁258向外延伸,该凸起260可用作例如分立凸块或球块,或可包括绕球囊252全部外边界或部分外边界延伸的梁。凸起260可相互隔开,如图所示,或可为外壁258的连续构造表面。凸起260的另一可替换的结构包括沿球囊252的长度连续或半连续延伸的一个或多个旋梁。
选择从外壁258伸出的任何凸起260的数量、间隔和特定结构以提供和/或促进适配器支架相对于特定程序的特定部件。即,可提供这些凸起以例如增加球囊252的径向力、减少其转移的风险和/或增进适配器支架的整个结构完整性。提供的任何凸起260可使用与制成球囊的材料相同或不同的材料与外壁258整体成形或可粘于或另行连于球囊252。这种可替换的凸起的一个示例是伸入外壁258并从外壁258伸出的塞子,例如明尼苏达州(Minnesota)金山谷市(Golden Valley)的AGA医药公司商购类型的名为“安普拉兹(AMPLATZER)血管塞”的自扩张圆柱形网丝装置。
图12示出了适配器支架270的另一实施例的一部分,包括球囊272,该球囊272环绕延伸基本穿过球囊272中心的内通道274。球囊272包括与确定内通道274的内壁278隔开的外壁276。外壁276具有在其长度上基本恒定的直径;但内壁278包括伸入内通道274的至少一个凸起280。凸起280可根据需要包括以上相对于从适配器支架250外壁258伸出的凸起所述或设想的任何变化。该凸起280的一个功能是控制适配器支架内新瓣膜的位置,例如以避免瓣膜转移。即,该凸起有助于引入、定位和/或固定瓣膜于适配器支架内。另外,单个适配器支架可使用从其内壁和外壁伸出且沿所有或部分壁长的凸起组合。
图13示出了适配器支架300的又一实施例,还包括定位于其中的瓣膜段302。适配器支架300包括环绕基本圆柱形内通道306的球囊304。内通道306包括至少一个曲线部分308,从而改变沿其部分长度上的内通道306的直径。在一个实施例中,提供了分立的曲线部分308以相应于将用于其中的特定瓣膜的各小叶。即,如果将使用三叶瓣膜,则可提供三个相应的曲线或球形部分308。因此,曲线部分308可相应于将置入瓣膜的解剖或天然形状。但是,曲线部分308也可绕球囊304全部或部分内边界连续。这种曲线部分可替换或额外地提供于适配器支架外壁上以符合病人的组织。
图6示出了已开发的带支架瓣膜静脉段50的另一示例,该带支架瓣膜静脉段50可定位于先植入如适配器支架200的适配器支架内。带支架静脉段50可相应于上述所引用的Tower等人和Bonhoeffer等人的参考文献所述,并基本包括支架52和静脉段54。带支架静脉段50的外直径可扩张至与适配器支架202的内通道204的直径一样大。支架52可由铂、不锈钢或其它生物相容金属制成。尽管可如以上所引Tower等人的申请中所述使用丝材制造,但也可通过加工金属管为支架而制造。静脉段54安装于支架52内,该静脉段54包括的瓣膜位于支架两端之间并通过缝合处56固定于支架。缝合处56位于支架的近端和远端处,且优选位于支架的所有或几乎所有交叉处,如图所示。制造带支架静脉段的更详细说明见受让人同时待决的以Philippe Bonhoeffer和Debra Ann Taitague等人名义于2005年11月18日提交并指定为美国No.11/282,275的美国专利申请《心脏瓣膜治疗设备及其制造方法》。
图7示出了输送图6所示类型的带瓣膜静脉段至先植入如适配器支架200的适配器支架内部的系统。输送系统60包括覆盖内球囊导管(图中不可见)的外壳62。外壳包括扩张的远端部分64,带支架带瓣膜静脉段置于该扩张的远端部分64中。静脉段压缩于内导管上的单个或双球囊周围。减缩尖端66安装于内导管的远端以有助于输送系统通过病人的脉管系统。所述系统也包括导丝68,可用于引导输送系统至其所需的植入位置。
图7的输送系统及其使用可与以上所引Tower等人申请所述相同,除了静脉段置于预先放置在例如适配器支架200的适配器支架中部内,而不是扩张抵住失常的自体或人工瓣膜。输送系统可使用导丝68前移至期望的瓣膜植入部位,之后收回外壳62以允许静脉段的球囊扩张,如图8所示,如下所述。
图8示出了在如适配器支架200的预先植入适配器支架中部内的如静脉段50的膨胀带支架带瓣膜静脉段的机构。外壳62移向近端,露出安装于内导管70上的球囊72。球囊72扩张,从而扩张静脉段50抵住预先植入的适配器支架的内表面,稳定并密封静脉段于适配器支架内。如果适配器支架内提供有凸起或其它引入部件,则静脉段50可与该部件接合。之后球囊紧缩并向近端退回输送系统。
图9是在本发明的适配器支架200内植入右心室流出道40的替换瓣膜的示意性横截面视图。如上所述,该替换瓣膜可在适配器支架植入病人的同时植入适配器支架200内,或替换瓣膜也可在植入适配器支架200后的一段时间植入。如图所示,适配器支架200的外表面208扩张抵住流出道40的内壁。如上面提出的,内通道204优选为保持适于固定并保持替换瓣膜的特定直径。因此,根据流出道40的尺寸,外表面208可相对靠近内通道204或与内通道204隔开较远。换句话说,如果流出道较大,则与流出道不大的结构相比,外表面208将与内通道204相隔较远。
适配器支架200的外表面208优选在其整个长度上接触流出道40的内表面,但部分外表面208也可不接触流出道。在任意情况下,充足的外表面208应与流出道40接触以完成密封并避免其在植入后的转移。附图所示适配器支架安装于自体瓣膜小叶42的下游以允许其在适配器支架200和带支架静脉段50植入期间持续工作。非必须地,静脉段50可在其最初植入后几周内被置于适配器支架200内。在此附图中,所示静脉段54的小叶58也位于适配器支架200内。
图10示出了可用于输送根据本发明的适配器支架的一个示例性系统,该系统与用于输送静脉段的系统稍稍相似。输送系统21包括覆盖内导管(附图中不可见)的外壳22。外壳22具有扩张的远端部分24,适配器支架200(具有或不具有带瓣膜静脉段)可置于其中。适配器支架200可最初处于折叠状态,压缩于内导管周围并由外壳22保持于其压缩结构。减缩尖端26安装于内导管的远端并用于有助于输送系统20通过脉管系统。所述系统也包括导丝28,导丝28可用于引导输送系统20至其期望的植入位置。
输送系统21还包括与适配器支架相通以在期望的植入部位膨胀或扩张的机构32。机构32可包括可提供期望材料至适配器支架200内部的多种装置,如可移动流体或凝胶至适配器支架200内的泵、可控制从而以预定量膨胀适配器支架200的压缩空气或其它气体源等。即,用于适配器支架200内的材料将确定用于膨胀或扩张的机构32的类型。非必须地,输送系统21和/或适配器支架200可提供有密封机构(未示出)以在材料注入或置入其中后密封或闭合适配器支架200内的任何开口以保持材料不从支架200泄漏。
外壳22可响应于适配器支架200的扩张通过机构32移向近端,或通过从一端拉动外壳22而移向近端,从而允许适配器支架200远离内导管30扩张,如该装置结构所示。适配器支架200的远端段可接合心血管壁于期望的植入位置,从而稳定支架。之后外壳22进一步移向近端,释放适配器支架的近端段,其后适配器支架在其直径方向上自由扩张直至接触心血管壁。材料可持续添加至适配器支架200直至其膨胀或扩张至期望的尺寸。之后向近端收回输送系统。在特定结构中,带瓣膜静脉段预安装于适配器支架200内,使得其中安装有带瓣膜静脉段的适配器支架200的膨胀或扩张完成替换瓣膜的植入。可替换地,带瓣膜静脉段可在以后置入适配器支架内。
已说明并示出的用于本发明的适配器支架的带支架带瓣膜静脉段可压缩以安装于病人体内且可例如通过输送系统的球囊部分扩张。但是,也应理解也可使用其它类型的带支架瓣膜,如称为自扩张的类型。该自扩张支架可压缩以安装至病人体内,之后容易地通过移除用于保持支架处于压缩状态的特定外力而扩张至期望尺寸。也可使用可以本文所述以外方式压缩并扩张的其它类型带支架瓣膜,只要瓣膜可置入于病人体内的适配器支架内。
再次参照图13,瓣膜段302已预连接或预安装于球囊304的内通道306中,使得植入程序可在单个步骤中完成。即,并非先安装适配器支架,之后再安装瓣膜段于内通道中,图13示出了适配器支架组件,该适配器支架组件允许外科医生免除使用具有球囊以扩张瓣膜段的输送系统。所示瓣膜段302基本为牛颈静脉形式,该牛颈静脉形式包括可扩张至球囊304的曲线部分308内的球形区域310。因球形区域310没有压缩或变形到球囊304的内通道306内,因此该结构可在小叶312上提供更小的应力,但允许基本保持其自体解剖形式。
图14示出了连于根据本发明另一实施例的支架322内的瓣膜320(为清晰以虚线示出)的实施例,其中瓣膜320包括小叶324,且支架包括近端328和相对的远端326。近端328可在如通过缝合操作固定支架322至瓣膜320的程序期间至少部分覆盖例如组织。支架322可包括编织或丝网材料,或任何其它适当的支架材料。图15示出了位于适配器支架或球囊330内的图14所示的瓣膜-支架组件,其中小叶324基本位于球囊330的内通道332内,且支架322的近端328伸出球囊330的一端。支架322连接到球囊330,如通过绕支架322至少部分圆周缝合支架322的近端328至球囊330而连接支架322到球囊330。球囊330可提供有套囊或其它延伸部分(未示出)以连接支架而不影响球囊的强度。这时,其中安装有带支架瓣膜的适配器支架可装运至例如诊所。
非必须地,图14所示的瓣膜-支架组件可通过拉动支架322的远端326穿过球囊330的内通道332直至与图15相比基本内侧外翻而倒置为图16所示结构。这样,因压缩程序期间该区域内的材料容积小于带支架瓣膜将保持于内通道332内的材料容积,故连有带支架瓣膜的球囊可压缩为较小尺寸以使系统输送至病人体内。之后,适配器支架可以与相对本发明其它实施例所述的相同方式使用,如包括使用材料扩张球囊,移除输送装置等,但也可包括通过将支架322的远端326压回内通道332内以使其可以用作病人的瓣膜而颠倒上述置入处理的步骤。
最后,尽管上述发明特别适用于替换右心室流出道内的瓣膜,但本发明可用于替换其它血管或其它管状器官内的瓣膜。同样,尽管公开了牛颈静脉作为用于实施本发明的带瓣段源,但其它来源动物或来源血管也可替代。同样,也可使用聚合体或薄金属瓣膜。另外,也可使用上述授权给Cox的美国专利No.6,719,789和No.5,480,424的所述类型的可替换的示例性替换瓣膜。同样,上述说明应视为示例性的,而不是限制性的。
已参照几个实施例说明了本发明。本文所引任何专利、专利申请、出版和杂志论文均全文结合于此以供参考。前述详细说明和示例仅为清晰理解给出。其中不应理解有任何不必要的限制。对于本领域技术人员,很明显可对所述实施例做出许多改变而不背离本发明的范围。因此,本发明的范围不应限于本文所述结构,而仅由权利要求语言所述结构及其等效结构限制。
Claims (8)
1.一种用于放置瓣膜于直径大于该瓣膜直径的管状器官内的设备,该设备包括:
适配器,所述适配器包括由具有第一直径的圆柱形外壁环绕的封闭容积,该圆柱形外壁与具有小于所述第一直径的第二直径的圆柱形内壁同心隔开,第一端壁和第二端壁分别延伸于所述圆柱形外壁和所述圆柱形内壁之间的所述适配器的近端和远端处,且至少一个整体成形的凸起从所述圆柱形外壁和所述圆柱形内壁中的至少一个的表面上伸出;
所述封闭容积内包含的一定量的材料;
安装于所述适配器的圆柱形内壁内的瓣膜。
2.如权利要求1所述的设备,其中圆柱形外壁和圆柱形内壁以及延伸于所述圆柱形外壁和所述圆柱形内壁之间的所述第一端壁和所述第二端壁包括抗液态材料。
3.如权利要求1所述的设备,其中所述封闭容积内所含材料为液体材料。
4.如权利要求1所述的设备,其中所述封闭容积内所含材料为凝胶材料。
5.如权利要求1所述的设备,其中所述封闭容积内所含材料至少为半固体。
6.如权利要求1所述的设备,其中所述圆柱形外壁包括从该圆柱形外壁表面远离于所述设备的中心纵轴线而伸出的至少一个凸起。
7.如权利要求1所述的设备,其中所述圆柱形内壁包括从该圆柱形内壁表面朝向所述设备的中心纵轴线而伸出的至少一凸起。
8.如权利要求7所述的设备,其中所述至少一个整体成形的凸起包括相互隔开的多个凸起。
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US20230000620A1 (en) | 2023-01-05 |
CN101442958A (zh) | 2009-05-27 |
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WO2007127433A3 (en) | 2008-02-07 |
WO2007127433A2 (en) | 2007-11-08 |
EP2023859A2 (en) | 2009-02-18 |
EP2023859B1 (en) | 2012-12-26 |
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