CN1173674C - 多层复合管状结构及其制造方法 - Google Patents

多层复合管状结构及其制造方法 Download PDF

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CN1173674C
CN1173674C CNB97181483XA CN97181483A CN1173674C CN 1173674 C CN1173674 C CN 1173674C CN B97181483X A CNB97181483X A CN B97181483XA CN 97181483 A CN97181483 A CN 97181483A CN 1173674 C CN1173674 C CN 1173674C
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J��K����˹
J·K·埃克尔特
J·M·法里纳
J·P·加达
J·C·克利
J·G·托马斯
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STENT TECHNOLOGIES Inc
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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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • B32B15/00—Layered products comprising a layer of metal
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    • C—CHEMISTRY; METALLURGY
    • C21—METALLURGY OF IRON
    • C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
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    • 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
    • A61F2/82—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
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
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    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
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    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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    • A61F2310/00011—Metals or alloys
    • A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
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    • C21—METALLURGY OF IRON
    • C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
    • C21D2251/00—Treating composite or clad material
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Abstract

一用作一外科手术中移植件的多层复合管状结构，具有一生物相容性材料的外层(12)、一非透射性材料的中间层(14)和一生物相容性材料的内层(16)。这些层料被冶金术结合，以形成一易延展的复合移植件(10)，并且允许该复合移植件有大的变形而在生物相容性层(12，16)与非透射性材料层(14)之间不会发生分层。所形成的复合结构(10)在一荧光屏上是可见的，并且不会遮蔽移植件(10)本身的细节、或者绕移植件(10)周围的解剖器官。还公开了形成一多层复合管状结构(10)的方法。将一生物相容性材料管(12，16)同轴地环绕由非透射性材料所形成的一管(14)。例如通过管拉伸、模锻或深拉伸来同时减小这些管结构，直到形成所希望的直径和壁厚。然后对这些管件进行热处理，以使生物相容性层(12，16)与非透射性材料层(14)扩散粘接。

Description

多层复合管状结构及其制造方法
技术领域
本发明涉及多层复合管领域，尤其是用于外科手术中的移植件。本发明提供一用作一外科手术移植件的多层复合管状结构，其在一荧光屏上是可见的，但不会屏蔽解剖结构。本发明还提供一种在配置(deployment)和膨胀时不会分层的多层移植件。
背景技术
已经在大量的外科手术中采用移植件。例如，在有序的治疗过程中采用移植件来修复和支承受损的组织。将移植件植入目标位置并且膨胀到其原始直径的几倍，直到该移植件接触周围组织。该过程称为移植件的初始膨胀。接着，移植件进一步膨胀，以使其埋入周围解剖结构的壁内，例如一动脉内。该过程称为埋置(imbedding)。初始膨胀与埋置的过程称为配置(deployment)。一旦移植件膨胀，其即处于一固定位置。
一包括使用一移植件的普通外科手术的例子是在从冠状动脉内去除溶菌斑后，将一移植件植入该动脉内。在该情形中，移植件用来支承已被动脉粥样硬化溶菌斑阻塞的血管。
移植件也用于包括输尿管和尿道的外科手术中。例如，在前列腺外科术中，移植件用来保持泌尿系统管道的通畅。
在所有例如上述外科手术中，移植件的放置与定位是至关重要的。因此已开发了允许一内科医师或外科医生观察一移植件位置的各种方法，以正确地植入。这些方法中最常见的是使用一(x射线)荧光检查仪观察植入物。
现有技术的移植件通常是由例如不锈钢、钽或(镍钛金属互化物)NitinolTM的单一金属制造，其中最常用的材料是不锈钢。不锈钢移植件的一主要缺陷是其对于荧光屏是透明的。因此，采用不锈钢移植件需要在血流中注入不透明的染料，以使外科医生能看见移植件来进行定位和配置。这些染料消散得非常快，使得只能在短暂的时间内看到该移植件。因此，包括不锈钢移植件的手术和使用染料来观察移植件要求快速地选位和配置移植件。此外，移植件的缺乏可见性使得即使并非不可能、但也极为困难来验证移植件是否在一段时间后已改变位置。
钽是移植件中广泛使用的一非透射性材料。一固体钽移植件必须具有一在配置和功能方面均有用的最小厚度。固体钽移植件所需的厚度导致一在荧光屏上的高的发光度，而这会引起一些问题。(问题之)一是由钽移植件产生的荧光屏图像太亮，以至于消除了移植件图案的细节和移植件/脉管交界处的细节。因为不可能看到移植件/脉管交界处，因此准确地将移植件放置到脉管分枝中是费事的。此外，移植件不能被准确地观察到的事实使得更难以确定在移植件位置是否已出现例如再狭窄的脉管状态。
因为在各种解剖位置使用移植件，需要改变移植件的厚度，因而改变其强度，以弥补解剖的不同。例如，可以在具有不同程度肌肉量的解剖位置使用移植件。一多层移植件应当能弥补肌肉量的变化，例如采用不同厚度的移植件层。另外，还希望能改变一移植件的发光度，以弥补不同的解剖变化和不同程度的肌肉量。
外科手术移植件在配置过程中承受极大的塑性变形。在一多层移植件中，移植件的层必须不分层或分离。一多层移植件的任何分层将会产生粗糙的或尖锐的边缘，导致血栓症，和(导致)直接的解剖损伤，包括撕裂脉管。
外科手术实践中通常采用一气球单元来配置、膨胀和埋置外科手术移植件。在移植件技术中采用这些气球单元是公知的。采用一气球单元来膨胀一外科手术移植件，所用的压力是关键性的。需要一较高的压力来膨胀的移植件会带来增大的气球破裂的危险，而破裂会导致一栓塞。
因此，需要一种在一荧光屏上可见而又不屏蔽解剖结构的移植件。
还需要一种可以膨胀而不分层的多层移植件。
还需要一种可通过改变其厚度来改变强度的多层移植件，以适应不同的解剖结构。
还需要一种可通过改变移植件层的厚度来改变其在荧光屏上的发光度的多层移植件，以适应不同的解剖结构。
还需要一种在一较低的压力下膨胀的移植件和当配置时提供气球破裂的危险减少的多层移植件。
发明内容
本发明涉及一种能满足一移植件下列需要的结构：既可在一荧光屏上可见，又不遮蔽移植件本身或者围绕移植件周围的解剖结构的细节。本发明给这些需要提供了一确实创新和有效的解决方案。
一具有本发明特征的结构包括一多层复合移植件。该移植件的一层是由一非透射性材料形成。移植件的另一层是由一生物相容性材料形成。这些层的组合产生一种既生物相容、又在一荧光屏上可见，同时还不屏蔽移植件结构或周围的解剖结构的结构。
因此，本发明建议的一种用作一外科手术中之移植件的多层复合管状结构，用于保持身体脉管畅通的可扩张斯坦特，其中包括(a)一个由一生物相容性材料构成的外层；(b)一个由冶金术结合到该外层的一非透射性材料构成的中间层；(c)一个由冶金术结合到该中间层的一生物相容性材料构成的内层。
本发明还提供一种制造具有上述移植件特性之多层复合结构的方法。一作为本发明主题的多层复合结构是这样产生的：例如通过管拉伸、模锻或深拉伸一作为复合物的多重管或条带来使之减小，并且进行热处理来扩散粘接这些层。这导致一易延展的结构，其允许有大的变形而在生物相容性材料层与非透射性材料层之间不会分层。
因此，本发明建议的一种形成用作一外科手术中之移植件的多层复合管状结构的方法包括：a)将一生物相容性材料构成的管同轴地环绕一非透射性材料构成的管；b)将这些管同时减小到一所希望的直径并由此在管之间产生一残余夹紧应力；c)对管进行热处理，以形成这些管的扩散粘接，从而所形成的复合管是易延展的，并且允许变形而在非透射性材料与生物相容性材料之间不会分层。
为描述本发明，在附图中示出一目前较优的方式；但应当理解本发明并不限于所示的具体配置和手段。
附图说明
图1表示一根据本发明的移植件在蚀刻或加工前的局部透视图。
图2表示一沿图1的2-2线剖取的横剖视图，示出了移植件的诸层。
图3是一根据本发明的实际移植件在蚀刻或加工后一部分的电子显微图。
图4表示一根据本发明另一实施例的移植件在蚀刻或加工前的一分解局部剖开图。
图5是一沿图4的5-5线剖取的横剖视图，表示移植件的诸层。
图6是一根据本发明的移植件的另一实施例的横剖视图，表示一在层之间的金属夹片。
图7～9是一根据本发明制造一移植件的方法之局部剖视图。
图10是一根据本发明的移植件设置在一动脉内的横剖视图。
图11是一根据本发明的移植件在膨胀前的侧视图。
具体实施方式
现参照附图，其中相同的标记表示相同的元件，在图1和2中示出了根据本发明的一移植件10。在图1、2和3所示的本发明的优选实施例中，一移植件10包括一多层复合管状结构，其中，一外层12为生物相容性材料，一中层14为非透射性材料，一内层16也为生物相容性材料。在该优选实施例中，用于外层12和内层16的生物相容性材料是不锈钢，而非透射性中层14为钽。这些层材用下述方法结合(bond)在一起。图3所示的移植件10已被蚀刻和加工成一定的型式。
应认识到可用其它生物相容性材料来代替不锈钢。还应当认识到非透射性材料层14也不限于钽，而是可采用包括但不限于金、铂、和这些材料的合金之类的其它材料，这些均在本发明的范围之内。
在一不锈钢-钽-不锈钢的移植件、例如移植件10中，钽层14必须具有足够的厚度，以在一荧光屏(未示出)上提供一亮丽和清晰的图像。非透射性钽层14的厚度可以变化，以给脉管内靠近表面植入移植件的地方提供最优的发光效果，此时需要较低的发光，而对于例如肌肉组织内较深位置的手术，则需要较高的发光，因此就需要一较厚的非透射性钽层14。非透射性钽层14的厚度也可改变来适应具有不同组织密度的解剖位置，因为这些位置需要不同的移植件发光效果。
在本发明的另一实施例中，如图4和5所示，薄的非透射性材料层24可以通过电镀、蒸发、化学或其它薄膜沉积技术沉积在一生物相容性材料制成的第一管28的外表面26上。在图4和5中，为清晰起见，非透射性材料层24的相对厚度被夸大了。涂层的第一管28然后被冶金方式粘结到一第二管30上，如下所述在非透射性材料层24与第二管30之间形成一扩散层18。在另一实施例中，非透射性材料层24被沉积在一第一管(未示出)的内表面上，然后该第一管被同轴地设置和冶金术结合到一第二管上。
因此非透射性材料层14或24的厚度可以为移植件10壁厚的1％～95％。这样，发光效果可以很宽地变化，以适应不同的组织变化。
可以在本发明的移植件上增加附加的层，以形成各种合成移植件。例如，可形成一5层移植件，具有交替的不锈钢层和钽层，其中不锈钢层为最外层和最里层。
由于移植件10在配置和膨胀过程中必然会出现大的塑性变形，如前所述，因此不锈钢层与钽层之间所形成的粘接效果对于结构的功能是至关重要的。一机械粘接不足以满足根据本发明的移植件的要求。而是，一种发生材料成分扩散的冶金术结合是所希望的方案。该冶金术结合是通过向材料施加压力和热能形成的，正如下面所要描述的。
如图2所述，在结构的层之间形成一冶金术结合的同时，在相邻的层12与14、或者14与16之间的交界面处还设置一扩散层18。通过适当的热处理周期可以有效地影响和控制这些扩散层18的特性，导致一所希望的易延展的(柔软的)扩散层18，或者一不希望的易碎的(脆化的)金属中间层。
热处理、温度和时间关系可控制扩散元素的传输速率，导致在扩散层18内具有不同的元素成分和厚度。热处理周期对于不同的材料组合必须是优化的，从而扩散层18保持配置所需的易延展性。扩散层18还必须是，在确保粘接完整性和确保在移植件10配置而膨胀的过程中防止分层的易延展性前提下所需的最小厚度。
在本发明的另一实施例中，如图6所示，将可能不易相容并且将导致形成一不希望的易碎金属中间层的材料粘接在一起，可以通过使用一金属夹片20来完成。该夹片20用于同时控制通过扩散区22传输的扩散速率和元素。例如，可采用一金制夹片来便于形成一适当的扩散层18。
可采用下列方法来形成具有本发明特征的一多层复合管状结构。
例1
如前所提及，不锈钢与钽之间的扩散层18是通过适当施加压力和热处理来建立和控制的。这在扩散粘接的领域是周知的。在一形成本发明所采用的方法例子中，同轴地设置一由生物相容性材料制造的外管、一由非透射性材料制造的中管和一由生物相容性材料制造的内管，并且例如通过模锻或管拉伸来同时减小这些管。这种方式的管减小方法是周知的。以这种方法配置的一复合管状结构的例子表示在图1和3中。
在根据本发明的多层复合管状结构中，在层之间交界处的压力是由在复合拉伸操作后余留在管内的残余径向夹紧应力的结果所形成的。在管拉伸领域的普通技术人员将知道，增大面积缩减量和改变面积缩减量相对于壁厚缩减量的百分比，会增大或降低在一定限度内该残余应力的幅度。
在该方法的一例子中，如上所述设置一不锈钢外管、一钽中管和一不锈钢内管来形成复合结构。为便于层之间的正确粘接，应当在交界处建立一至少3.5千克/平方厘米(50p.s.i(磅/平方英寸))的残余夹紧应力。此外，必须在一有限的时间和温度范围内对复合管进行退火处理。该时间和温度范围的下限应当至少为843.3℃(1550华氏度)和至少6分钟。上限不应超过1010℃(1850华氏度)和15分钟。在该温度范围内复合管的退火将会产生一最小厚度的扩散层和保持所需易延展性的基本成分，以允许在较低压力下配置和膨胀，并且仍然可防止在膨胀过程中分层。
例2
在形成本发明的另一方法中，在一生物相容性材料内管的外表面上沉积一非透射性材料层。该配置示于图4中。可以通过诸如蒸发沉积、电镀、喷涂或类似方法的一覆层(涂覆)方法来沉积该非透射性材料层。然后绕该覆层内管设置一生物相容性材料外管。
然后一起拉伸复合管并且逐渐减小，直到获得所希望的残余夹紧应力，如上所述。然后如上所述对该管进行热处理，在非透射性材料层与外管的内表面之间形成一扩散粘接。
通过在外管的内表面上沉积非透射性材料层、并且将这一组合结构粘接到内管的外表面上都可完成该同样的过程。
例3
可用来形成一多层复合管状结构的另一方法包括使用一金属夹片20。该方法示于图6中。夹片20被设置在生物相容性材料层与非透射性材料层之间，并且用来控制通过扩散区传输的扩散速率和/或扩散微粒。然后一起拉伸并且逐渐减小这些多层管，直到获得所希望的残余夹紧应力，如上所述。然后如上所述对管进行热处理，以在非透射性材料与生物相容性材料之间形成一扩散粘接结构，这由夹片20而获得制做上的便利。
例4
可用来形成一根据本发明的多层复合管状结构之另一方法包括采用由一多层条带42进行深拉伸的步骤。深拉伸方法在管形成技术中是周知的。
在一实施例中，如图7、8和9所示，多层条带具有一不锈钢顶层54、一非透射性材料中层56和一不锈钢底层58。该条带42是在深拉伸处理之前通过冶金术结合诸层而制备的。在深拉伸处理的过程中，如图8所示，条带42被放置到一冲模44上，并且条带42例如被一冲头46压入该冲模44内。在冲模44内就形成一具有一封闭端50的一定壁厚的管48。采用一系列直径渐减的冲模重复该过程，直到形成一具有所希望的直径和壁厚的多层管。对于一定的材料组合，可能需要在逐渐拉伸操作中进行中间热处理，如上所述。一旦形成一所希望厚度和尺寸的管材，就切掉管48的封闭端50和弯曲边缘52，如图9所示。然后，如上所述对管件进行热处理，直到在层之间形成适当的金属间粘接。
一此处所述的复合结构的优点是，对于一宽范围的非透射性材料层厚度和材料，移植件10可以在一较小施加的力下扩张，与同样厚度的一固体不锈钢移植件所需的压力相比，这会传递较低的配置压力。这是因为复合结构的较低的模量。该较低的模量是由非透射性材料的较低的弯曲强度和/或较低的疲劳应变硬化率造成的。
在一使用一移植件的典型的外科手术中，用一低压气球(未示出)来使移植件进行初始膨胀，直到移植件壁接触一被打开的脉管，例如一动脉的壁为止。图10中所示的一移植件10与一动脉11的壁保持接触。然后撤除低压气球，插入一高压气球(未示出)，并且该移植件10被高压气球进一步膨胀开，进入动脉壁11内。该第二次膨胀是指“埋置”。与同样厚度的普通不锈钢移植件相比，具有一种1∶1∶1的不锈钢∶钽∶不锈钢比率的复合移植件的膨胀和埋置压力详细示于表1：
表1
    不锈钢        多层复合物1∶1∶1(不锈钢∶钽∶不锈钢)
    配置   4个大气压     3.5个大气压
膨胀(埋置)   8个大气压     7个大气压
与固体不锈钢移植件相比，给复合移植件采用较低膨胀和埋置压力的能力可控制其安全与可靠性。由于需要较低的压力来膨胀和埋置本发明的复合移植件，因此撕裂或损伤解剖的器官、组织或脉管周围的风险较小。此外，在气球单元上施加的应力较低，因此降低了气球破裂的危险和伴随的栓塞危险。
本发明可以具体化为其它特定的方式而不脱离其实质或基本特征，因此在确定本发明的保护范围时，应当参照所附的权利要求书而不是前述说明书。

Claims (51)

1.一用作一外科手术中之移植件的多层复合管状结构，用于保持身体脉管畅通的可扩张斯坦特，其特征在于包括：
(a)一个由一生物相容性材料构成的外层；
(b)一个由冶金术结合到该外层的一非透射性材料构成的中间层；和
(c)一个由冶金术结合到该中间层的一生物相容性材料构成的内层。
2.如权利要求1所述的多层复合管状结构，其特征是该外层是不锈钢料。
3.如权利要求1所述的多层复合管状结构，其特征是该内层是不锈钢料。
4.如权利要求1所述的多层复合管状结构，其特征是该中间层是包括钽、金、金合金、铂和铂合金的组中的一种。
5.如权利要求1所述的多层复合管状结构，其特征是该中间层的厚度被选择成在一荧光屏上产生预选的发光效果。
6.一用作一外科手术中之移植件的多层复合管状结构，用于保持身体脉管畅通的可扩张斯坦特，其特征在于包括：
a.一生物相容性材料的外管；
b.一生物相容性材料的内管，该内管具有一沉积在其外表面上的非透射性材料层，该非透射性材料层被冶金术结合到外管上。
7.如权利要求6所述的多层复合管状结构，其特征是该非透射性材料层是通过包括蒸发沉积、电镀和喷涂中的一种沉积到内管的外表面上的。
8.如权利要求6所述的多层复合管状结构，其特征是该外管由不锈钢形成的。
9.如权利要求6所述的多层复合管状结构，其特征是该内管由不锈钢形成的。
10.如权利要求6所述的多层复合管状结构，其特征是该非透射性材料层是包括钽、金、金合金、铂和铂合金的组中的一种。
11.如权利要求6所述的多层复合管状结构，其特征是该非透射性材料层的厚度被选择成在一荧光屏上产生预选的发光效果。
12.一用作一外科手术中移植件的多层复合管状结构，用于保持身体脉管畅通的可扩张斯坦特，其特征在于包括：
a.一生物相容性材料的外管，该外管具有一沉积在其内表面上的非透射性材料层；
b.一生物相容性材料的内管，该非透射性材料层被冶金术结合到该内管上。
13.如权利要求12所述的多层复合管状结构，其特征是该非透射性材料层是通过包括蒸发沉积、电镀和喷涂中的一种沉积到外管的内表面上的。
14.如权利要求12所述的多层复合管状结构，其特征是该外管由不锈钢形成。
15.如权利要求12所述的多层复合管状结构，其特征是该内管由不锈钢形成。
16.如权利要求12所述的多层复合管状结构，其特征是该非透射性材料层是包括钽、金、金合金、铂和铂合金的组中的一种。
17.如权利要求12所述的多层复合管状结构，其特征是该非透射性材料层的厚度被选择成在一荧光屏上产生预选的发光效果。
18.一用作一外科手术中之移植件的多层复合管状结构，包括一非透射性材料层，一生物相容性材料层和一在该非透射性材料层与生物相容性材料层之间的金属夹片。
19.如权利要求18所述的多层复合管状结构，其特征是该金属夹片是由金形成的。
20.如权利要求18所述的多层复合管状结构，其特征是该非透射性材料层的厚度被选择成在一荧光屏上产生预选的发光效果。
21.一形成用作一外科手术中之移植件的多层复合管状结构的方法，包括：
a.将一生物相容性材料构成的管同轴地环绕一非透射性材料构成的管；
b.将这些管同时减小到一所希望的直径并由此在管之间产生一残余夹紧应力；
c.对管进行热处理，以形成这些管的扩散粘接，从而所形成的复合管是易延展的，并且允许变形而在非透射性材料与生物相容性材料之间不会分层。
22.如权利要求21所述的形成一多层复合管状结构的方法，其特征是通过管拉伸和模锻步骤之一来减小所述这些管。
23.如权利要求21所述的形成一多层复合管状结构的方法，其特征是残余夹紧应力至少为3.5千克/平方厘米。
24.如权利要求21所述的形成一多层复合管状结构的方法，其特征是在至少843.3℃不超过1010℃的一温度下加热。
25.如权利要求21所述的形成一多层复合管状结构的方法，其特征是加热6～15分钟。
26.如权利要求21所述的形成一多层复合管状结构的方法，其特征是在843.3～1010℃的温度范围内加热6～15分钟。
27.一形成用作一外科手术中之多层复合管状结构的方法，其中多层复合管状结构用于保持身体脉管畅通的可扩张斯坦特，其特征在于包括：
a.在一由生物相容性材料构成的第一管的外表面上沉积一非透射性材料层；
b.将一由生物相容性材料形成的第二管同轴地环绕该第一管；
c.将这些管同时减小到一所希望的直径并由此在管之间产生一残余夹紧应力；
d.对这些管进行热处理，以使非透射性材料层扩散粘接到第二管上，从而形成一易延展的复合管，并且允许该复合管变形而在非透射性材料层与生物相容性材料之间不会分层。
28.如权利要求27所述的形成一多层复合管状结构的方法，其特征是非透射性材料是通过包括蒸发沉积、电镀和喷涂中的一种沉积到第一管的外表面上的。
29.如权利要求27所述的形成一多层复合管状结构的方法，其特征是通过管拉伸和模锻步骤之一来减小这些管。
30.如权利要求27所述的形成一多层复合管状结构的方法，其特征是残余夹紧应力至少为3.5千克/平方厘米。
31.如权利要求27所述的形成一多层复合管状结构的方法，其特征是在至少843.3℃不超过1010℃的一温度下加热。
32.如权利要求27所述的形成一多层复合管状结构的方法，其特征是加热6～15分钟。
33.如权利要求27所述的形成一多层复合管状结构的方法，其特征是在843.3～1010℃的温度范围内加热6～15分钟。
34.一形成用作一外科手术中之移植件的多层复合管状结构的方法，其中多层复合管状结构用于保持身体脉管畅通的可扩张斯坦特，其特征在于包括：
a.在一生物相容性材料的第一管的内表面上沉积一非透射性材料层；
b.将该第一管同轴地环绕一生物相容性材料的第二管；
c.将这些管结构同时减小到一所希望的直径并由此在管之间产生一残余夹紧应力；
d.对管结构进行热处理，以使非透射性材料层与第二管的外表面扩散粘接，其中所形成的复合管是易延展的，并且允许该复合管变形而在非透射性材料层与生物相容性材料之间不会分层。
35.如权利要求34所述的形成一多层复合管状结构的方法，其特征是非透射性材料层是通过包括蒸发沉积、电镀和喷涂中的一种沉积到第一管的内表面上的。
36.如权利要求34所述的形成一多层复合管状结构的方法，其特征是通过管拉伸和模锻步骤之一来减小这些管。
37.如权利要求34所述的形成一多层复合管状结构的方法，其特征是残余夹紧应力至少为3.5千克/平方厘米。
38.如权利要求34所述的形成一多层复合管状结构的方法，其特征是在至少843.3℃不超过1010℃的一温度下加热。
39.如权利要求34所述的形成一多层复合管状结构的方法，其特征是加热6～15分钟。
40.如权利要求34所述的形成一多层复合管状结构的方法，其特征是在843.3～1010℃的温度范围内加热6～15分钟。
41.一形成用作一外科手术中之移植件的多层复合管状结构的方法，包括：
a.用一生物相容性材料构成的管同轴地环绕一非透射性材料构成的管；
b.将一金属夹片设置在该非透射性管与生物相容性管之间；
c.将这些管结构同时减小到一所希望的直径并由此在管之间产生一残余夹紧应力；
d.对管结构进行热处理，以使非透射性材料层与生物相容性层扩散粘接，从而所形成的复合管是易延展的，并且允许该复合管变形而不会分层。
42.如权利要求41所述的形成一多层复合管状结构的方法，其特征是通过管拉伸和模锻步骤之一来减小层结构。
43.如权利要求41所述的形成一多层复合管状结构的方法，其特征是残余夹紧应力至少为3.5千克/平方厘米。
44.如权利要求41所述的形成一多层复合管状结构的方法，其特征是在至少843.3℃不超过1010℃的一温度下加热。
45.如权利要求41所述的形成一多层复合管状结构的方法，其特征是加热6～15分钟。
46.如权利要求41所述的形成一多层复合管状结构的方法，其特征是在843.3～1010℃的温度范围内加热6～15分钟。
47.一形成用作一外科手术中之移植件的多层复合管状结构的方法，其中多层复合管状结构用于保持身体脉管畅通的可扩张斯坦特，其特征在于包括：
a.将一具有一非透射性材料层和一生物相容性材料层的条带放置到一冲模上；
b.通过一系列的冲模深拉伸该条带来减小所述条带的厚度，从而在层结构之间产生一夹紧应力并且形成一具有一封闭端的所需壁厚的管结构；
c.一旦获得所需的壁厚，就切除管的封闭端；和
d.对管件进行热处理，以使非透射性材料层与生物相容性材料层扩散粘接，从而所形成的复合管是易延展的，并且允许该复合管变形而在非透射性材料层与生物相容性材料层之间不会分层。
48.如权利要求47所述的形成一多层复合管状结构的方法，其特征是残余夹紧应力至少为3.5千克/平方厘米。
49.如权利要求47所述的形成一多层复合管状结构的方法，其特征是在至少843.3℃不超过1010℃的一温度下加热。
50.如权利要求47所述的形成一多层复合管状结构的方法，其特征是加热6～15分钟。
51.如权利要求47所述的形成一多层复合管状结构的方法，其特征是在843.3～1010℃的温度范围内加热6～15分钟。
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