CN1203816C - 导管人工心脏瓣膜及其制造方法 - Google Patents
导管人工心脏瓣膜及其制造方法 Download PDFInfo
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C69/00—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore
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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
- A61F2/02—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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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
- B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
- B29C41/08—Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
- B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
- B29C41/14—Dipping a core
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C2791/00—Shaping characteristics in general
- B29C2791/001—Shaping in several steps
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7532—Artificial members, protheses
Abstract
本发明涉及一种导管人工心脏瓣膜,它由一圆柱形的或设有球形突起的具有一带有基环的内置支承壳体的软管组成,基环支承至少两个基本上指向环的轴线方向的、通过一圆弧形的用来固定柔性的膜瓣的壁连接的支柱。为了达到改善生理性能,建议:软管、支承壳体和膜瓣由唯一的一种材料,尤其是聚氨酯或一种其他的聚合物组成,并形成一个整体的物体。
Description
技术领域
本发明涉及一种导管人工心脏瓣膜,由一圆柱形的或设有球形突起的具有一带有基环的内置支承壳体的软管组成,基环支承至少两个基本上指向环的轴线方向的、通过一圆弧形的用来固定柔性的膜瓣的壁连接的支柱。
其次本发明涉及一种制造导管人工心脏瓣膜的方法,其中为了制造膜瓣,将一设有相应于膜瓣的形状成形的表面的芯体多次浸渍在聚氨酯溶液内,使每次浸渍过程之间在芯体表面上形成的聚氨酯膜干燥,然后通过其他并接方法使膜瓣与软管连接。
背景技术
导管人工心脏瓣膜是一种特殊的人工心脏瓣膜,其中,膜瓣直接内置在以解剖学方式、必要时以所谓球茎形状成形的血管末端内。
为了达到接近生理学的血液流动,其中血细胞的流体动力学载荷是可以承受的,在过去已经进行过试验,采用塑料,它们是适合生物生存的并且由于其机械性能在功能方面可以完全接近天然心脏瓣膜。在EP0114025B1中叙述了制造人工心脏瓣膜的方法。例如通过将一相应地成形的芯体一次或多次浸入聚氨酯溶液中制成的瓣膜膜瓣可以与瓣膜壳体粘合。但是在粘接时在瓣膜膜瓣和瓣膜壳体之间的交接处不得不产生粘接剂残留物,从而造成不平面度,这可能导致细胞状的血液组成部分的沉积,带来继发性的钙化(Kalzifizierung)。
作为另一种选择在所述资料中介绍,借助于一两件式的芯体首先可以通过浸渍形成瓣膜膜瓣,接着(在装入另一部分芯体以后)制造一种瓣膜壳体,而且同样是通过浸渍,其中在这个过程中瓣膜膜瓣的交接处与瓣膜壳体连接。但是这种方法费用比较高,因为必须采用非常精确地协调的分芯体,这里可能出现层厚差,它可能导致不规则的应力。
为了避免这些缺点在EP0114025B1中建议,一具有相应于待形成的瓣膜膜瓣制成的成形面的芯体(由高级合金钢或塑料制成)放入一粘度在24-192Pa·s范围内的第一种聚合物溶液中,并且以非常小的下降速度放入,它防止在下降过程中形成气泡等等和在芯体上形成的聚合物内的不均匀性。在完全浸渍后将带有在它上面形成的膜的芯体从溶液中取出并加以干燥。
根据所希望的层厚的不同这个过程可以多次重复。在一具有在1.5-2Pa·s范围内的较低粘度的第二种聚合物溶液中预制的瓣膜壳体这样地保持在溶液中,使溶液可以通过在下面的流出孔从瓣膜壳体内部流出。覆盖了膜瓣的芯体浸入这种第二种聚合物溶液中并插入固定在这种溶液中的瓣膜环内。在零件在溶液中短时间停留以后将芯体连同瓣膜壳体从溶液中取出,并加以干燥。最后将这样制成的心脏瓣膜从芯体上取下。因此这样制成的心脏瓣膜由一支承壳体组成,在它上面固定许多膜瓣。设有一接缝环的这种心脏瓣膜适合于装在人的血管内。原则上,并且像例如在WO97/49356中所提到的那样,这种结构也可以用于导管瓣膜植入物,但是在所述资料中没有提到,应该怎样制造导管人工心脏瓣膜。
发明内容
因此本发明的目的是,创造一种开头所述类型的导管人工心脏瓣膜,它在生理学性能方面更完善。特别是这种导管人工心脏瓣膜应该可以用于儿童。
上述目的通过这样的方法来实现,即软管、支承壳体和膜瓣由单独的一种材料,尤其是聚氨酯或一种其他的聚合物组成,并构成一单件物体。“单独的一种材料”也指这样的实施形式,即其中采用例如同一种材料组的不同聚氨酯,在某些情况下具有不同的机械性能。根据对各个导管组成部分的柔性和弹性的不同要求这里可以分别通过不同的材料厚度以及不同硬度或不同弯曲强度的聚氨酯加以考虑。在各个预制零件等之间的粘接部位在采用不同材料时产生的应力区可以通过统一采用聚氨酯有效地避免。
连接在支承壳体上的软管末端由一种微孔的细纤维弹性聚氨酯组成,它具有比同样由聚氨酯组成的支承壳体大的弹性。
如果需要的话,在支承壳体的基环内可以内置一加强环,该环最好由钛或钛合金组成。
为了制造所述导管人工瓣膜,在加工完膜瓣以后将芯体(连同在它上面的膜瓣)定向安置在一注塑模内,注塑模的型腔具有支承壳体的轮廓,并通过注塑将支承壳体浇注在膜瓣上,然后在入口和出口一侧的支承壳体上通过喷溅将软管末端喷溅到相应的模具上。因此导管人工心脏瓣膜的制造工艺由三个单独的工序组成,也就是按现有技术的原理用浸渍/摇摆法制造膜瓣以及另外两个单独的喷注工序,其中分别在预先加工好的组成部分上首先浇注上支承体,然而浇注上软管末端(或者如果单独制造软管末端的话)将软管末端粘接在加工好的组成部分上(带膜瓣的外壳)。
对此的另一种选择是按照本发明这样地制造导管人工瓣膜,即首先在一设有按照膜瓣的形状成形的表面的芯体上逐点地、以一定顺序线形地、焊缝形地或平面形地在芯体上涂覆聚合物溶液点滴或粘性的聚合的多组分体系的点滴或连续液流,使涂层干燥,再涂覆单滴或液流。接着干燥,如此多次反复,直至形成作为膜瓣的所希望的形状相符的三维聚合物体,接着将膜瓣的自由棱边分开,此后将一膜瓣的模具套在对应模具的相应表面上,对应模具用来相应地形成流出端的部分,在某些情况下也可以包含球茎形突起。支承壳体通过浸入聚合物溶液或通过按上述方法的液滴涂覆生成,在支承壳体的底部区域内套上一最好由钛或钛合金组成的金属环,接着通过浸入相应溶液内加上中间干燥或通过液滴涂覆用聚合物包裹此金属环,此后两个用来形成软管末端的模具用聚合物材料喷涂,由此形成具有细纤维的微孔结构的固有的脉管。这种细纤维的微孔结构从表面观察具有约20μm至80μm尺寸的孔。在某些情况下也可以在个别层内定向地埋入纤维,其中按本发明的一种结构方案纤维的粗细为0.5μm至20μm,尤其是2μm至10μm。按照本发明一种可供选择的实施形式也可以在相应的纤维涂覆以后将一无纺布从外部这样地在支承壳体上浸透,使得整个横截面变成一聚氨酯膜。膜瓣固定在其上面的支承壳(外壳)的外表面可以在喷溅过程之前用聚合物溶液或纯的溶剂溶解,以造成支承壳体和纤维之间更好的附着。因为固有的血管由于其结构具有非常好的弹性,首先对应模具(带球茎)可以脱模,然后芯体脱模。
附图说明
在附图中表示本发明的一个实施例。附图表示:
图1一导管人工心脏瓣膜的示意图,
图2作为制造导管心脏瓣膜模具的芯体,
图3导管人工心脏瓣膜的一局部纵剖视,此人工心脏瓣膜借助于图2中所示的模具制造,
图4横截面(垂直于流通方向)的一块,
图5按图3的导管人工心脏瓣膜的一个局部纵剖视。
具体实施方式
按图1的导管人工心脏瓣膜由一带一内置的支承壳体2的圆柱形软管1组成,支承壳体支承一基环21以及三个基本上指向环的轴线方向的、通过圆弧形的用来固定柔性的膜瓣3、4和5的壁连接的支柱22、23、24。所述的所有零件都由聚氨酯组成。在某些情况下支承环21内还可以内置一起加强作用的钛环6。
支承体以及膜瓣原则上按在例如WO97/49356中所述的那样构成。然而在所述情况下,主动脉瓣膜是导管人工瓣膜的一体组成部分,它可以按以下方法制造:
首先在一芯体(它例如可以具有在EP0114025B1中所述的形状和造型)生成三个膜瓣3、4、和5。这可以通过多次浸渍过程加上中间干燥进行,直至达到所希望的膜瓣厚。接着将膜瓣在用数字7表示的线处分开。然后将浸渍模放入注塑模内,注塑模的内腔具有支承壳体的形状,其中在某些情况下钛环6已通过相应的支架支承在内腔内。在注塑支承壳体时膜瓣在边缘区域8、9处与支承壳体连接,此后将由支承壳体和膜瓣组成的单元从模具中取出,并放入另一模具中,在模具内同样喷注上末端一侧的软管段1,或(在单独加工后)将软管段通过粘接固定。对于所有的工序采用聚氨酯,但是其中各种材料的硬度和弯曲强度是不同的。软管末端1由微孔的、弹性明显大于支承壳体2的聚氨酯的弹性聚氨酯组成,支承壳体又具有比薄壁的膜瓣3、4和5小的柔性。
图2表示一芯体30,它在其正面上分别具有成形面31,它们相应于待制造的三个用于主动脉心脏瓣膜的膜瓣的所希望的几何形状。其次图2表示一物体32,它在其正面上做成含有成形面的结构31的对应模具,并具有侧向外翻33,它们相应于以后的导管心脏瓣膜的待制造的球茎。在某些情况下物体32在其正面上可以具有一表面,膜瓣与其在朝向外壳(Stent)的棱边处仅仅线接触。
为了制造导管心脏瓣膜首先通过浸渍或点滴涂层或通过聚合物溶液液流涂层在成形面31上产生膜瓣3、4和5,其中需要多次浸渍或滴定过程。接着将生成的膜瓣沿膜瓣的自由棱边分开,然后将对应模具32压在膜瓣上。接着根据在图1中原理性表示的外壳2通过浇注、一次或多次浸渍过程,或者通过点滴涂覆或聚合物溶液的液流涂覆生成膜瓣张紧的加强筋(支柱)。其中在这中间在模具30上套上钛环6,最后通过继续浇注、浸渍或其他定量给料地涂覆的涂层将钛环完全包围。
最后两个将模具32和30环绕喷射,使得形成按图3的具有细纤维的微孔结构的固有的血管34。外壳2的外表面在喷涂过程之前或之后可以用聚合物溶液或纯的溶剂溶解,以造成均质的外壳和软管末端1之间更好的附着。因为固有的血管由于其结构具有非常好的弹性,可以先将带球茎33的对应模具32脱模,最后将芯体30脱模。球茎用图形标记35表示。
Claims (8)
1.导管人工瓣膜,由一圆柱形的或设有球形突起的具有一带一基环(21)的内置支承壳体(2)的软管(1)组成,基环支承着基本上指向环的轴线方向(3)的、通过一圆弧形的用来固定柔性的膜瓣的壁连接的支柱(22、23、24),其特征为:
所述软管(1)、支承壳体(2)和膜瓣(3、4、5)由唯一一种材料,即,一种聚合物组成,并形成一单件的物体。
2.按权利要求1的导管人工瓣膜,其特征为:所述聚合物是一种聚氨酯。
3.按权利要求1或2的导管人工瓣膜,其特征为:具有两个支柱。
4.按权利要求1或2的导管人工瓣膜,其特征为:具有三个支柱。
5.按权利要求1的导管人工瓣膜,其特征为:连接在支承壳体(2)上的软管末端(1)由微孔的、弹性聚氨酯组成,它具有比支承壳体(2)大的弹性,其中微孔材料具有气孔,它们在表面观察时具有20μm至80μm的尺寸。
6.按权利要求1至5之一的导管人工瓣膜,其特征为:在基环(21)内内置一加强环(6)。
7.按权利要求6的导管人工瓣膜,其特征为:所述加强环由钛或钛合金组成。
8.用来制造按权利要求1至7之一的导管人工瓣膜的方法,其特征为:首先在一设有按膜瓣的形状成形的表面(31)的芯体(30)上逐点地、以一定顺序线形地、焊缝形地或平面形地在基体上或模具上涂覆一种聚合物溶液的点滴或液流,或涂覆粘性的聚合的多组分体系的点滴或液流,使涂层干燥,再涂覆点滴或液流,接着再干燥,如此多次反复,直至形成作为膜瓣膜的所希望的形状符合的三维聚合物体,接着将膜瓣的自由棱边分开,然后套上一个对应模具(32)的与膜瓣的模具对应的表面,对应模具相应地做得用于形成流出端的部分,在某些情况下也可以包含球形突起(33),通过在聚合物溶液内的浸渍或通过点滴涂覆或通过连续液流涂覆在芯模(30)上生成一支承壳体(2),在这个支承壳体(2)的底部区域内套上一个金属环(6),接着通过浸入相应溶液内和中间的干燥或者通过液流或点滴涂覆用聚合物包裹此金属环,然后通过最后的两个模具(32、30)的环绕喷涂形成软管末端(1),或者单独制造软管末端并进行粘接。
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DE10050099.4 | 2000-10-09 | ||
DE10050099A DE10050099A1 (de) | 2000-10-09 | 2000-10-09 | Konduit-Herzklappenprothese und Verfahren zu ihrer Herstellung |
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CN1449265A CN1449265A (zh) | 2003-10-15 |
CN1203816C true CN1203816C (zh) | 2005-06-01 |
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US (1) | US20030187500A1 (zh) |
EP (1) | EP1324721A2 (zh) |
JP (1) | JP2004510546A (zh) |
CN (1) | CN1203816C (zh) |
BR (1) | BR0114158A (zh) |
CA (1) | CA2423272A1 (zh) |
DE (1) | DE10050099A1 (zh) |
MX (1) | MXPA03002315A (zh) |
WO (1) | WO2002030332A2 (zh) |
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JP5676115B2 (ja) * | 2009-07-02 | 2015-02-25 | 独立行政法人国立循環器病研究センター | 弁付人工血管及び弁付人工血管用柱状芯基材並びに弁付人工血管の製造方法 |
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-
2000
- 2000-10-09 DE DE10050099A patent/DE10050099A1/de not_active Withdrawn
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2001
- 2001-10-02 WO PCT/DE2001/003809 patent/WO2002030332A2/de not_active Application Discontinuation
- 2001-10-02 EP EP01986587A patent/EP1324721A2/de not_active Withdrawn
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- 2001-10-02 MX MXPA03002315A patent/MXPA03002315A/es not_active Application Discontinuation
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CN100346754C (zh) * | 2005-07-08 | 2007-11-07 | 北京佰仁医疗科技有限公司 | 无支架人工生物瓣 |
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CN1449265A (zh) | 2003-10-15 |
WO2002030332A3 (de) | 2002-08-29 |
WO2002030332A2 (de) | 2002-04-18 |
DE10050099A1 (de) | 2002-04-18 |
CA2423272A1 (en) | 2003-03-24 |
BR0114158A (pt) | 2003-07-29 |
US20030187500A1 (en) | 2003-10-02 |
EP1324721A2 (de) | 2003-07-09 |
MXPA03002315A (es) | 2004-12-03 |
JP2004510546A (ja) | 2004-04-08 |
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