CN114728446A - 由生物相容性有机硅生产植入物的方法 - Google Patents

由生物相容性有机硅生产植入物的方法 Download PDF

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Publication number
CN114728446A
CN114728446A CN202080081034.1A CN202080081034A CN114728446A CN 114728446 A CN114728446 A CN 114728446A CN 202080081034 A CN202080081034 A CN 202080081034A CN 114728446 A CN114728446 A CN 114728446A
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China
Prior art keywords
mold
implant
silicone
coating
casting
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CN202080081034.1A
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English (en)
Inventor
F·克雷恩
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Novatec SA
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Novatec SA
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Publication of CN114728446A publication Critical patent/CN114728446A/zh
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    • B29C33/00—Moulds or cores; Details thereof or accessories therefor
    • B29C33/38—Moulds or cores; Details thereof or accessories therefor characterised by the material or the manufacturing process
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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Abstract

本发明涉及一种由生物相容性有机硅生产植入物的方法，其包括以下步骤：提供待生产的植入物的3D数学模型；借助植入物的3D模型，创建植入物铸模的3D模型作为模具；所述铸模由聚合物材料通过增材制造工艺制成；至少在与待浇铸的有机硅接触的区域对所述铸模进行涂层；所述涂层是借助聚对二甲苯类涂层材料的气相沉积进行的；将生物相容性有机硅引入经涂层的铸模的模腔中；加热所述铸模，使所述有机硅硫化并且经硫化的植入物在冷却后从铸模中脱模。

Description

由生物相容性有机硅生产植入物的方法
本发明涉及一种根据专利权利要求1的由生物相容性有机硅生产植入物的方法。
分别根据应用，植入物在体内的停留时间可以从数小时到一生不等。因为根据其用途，植入物，例如支架与身体组织、皮肤、黏膜或体液(如血液、唾液或分泌物)直接接触，由适宜的材料构成是很重要的。基于DIN EN ISO 10993评估相应应用情况下的适用性。
ISO 10993标准是医学产品生物学评价的一系列ISO标准。该标准的目的是评估有关所用材料与身体相容性的生物学评价。因此，不仅要检查产品，还要检查用于生产医学产品的起始材料。除生物测试外，该标准还包括对溶解材料和物质的物理化学测试和分析，并规定了对可溶解物质的限制值。
已知有机硅弹性体的一个基本特性是它们在人体中具有非常好的生物相容性。有机硅是指一类合成聚合物，其中硅原子通过氧原子连接分子链和/或网状连接。硅的剩余自由价电子在此被烃残基(主要是甲基)饱和。在科学文献中，通常使用术语聚(有机)硅氧烷或简称硅氧烷来代替有机硅。
在医疗技术中，主要使用铂催化的2组分热固性有机硅。这些都受到严格的质量保证，并作为“无限制的”被提供用于在患者体内无期限的停留时间。
对于某些长期植入物，例如气管-支气管支架，仅高分子(即高粘度)的原材料是适合的。这些导致在10MPa的应力下超过500％的高拉伸强度。硬度为40至90肖氏A。由此可以生产具有在低壁厚的情况下高稳定性的血管支架。
将这种有机硅弹性体成型为支架，对于高粘度有机硅(HCR高稠度橡胶)通过热压或对于液态有机硅LSR(液态硅橡胶)通过在加热工具中注塑来进行。出于稳定性原因和更好的热传导，这些工具主要由金属制成。硫化在120℃至180℃下进行，持续每毫米壁厚约10秒。较高的温度会缩短硫化时间。
至今有机硅气管-支气管支架已成为医学系列产品。但是，出于某些解剖学或医学观点，许多患者无法使用系列产品进行治疗，而是依赖于在短时间内可提供的个体血管支撑。当件数为一时，理论上通过所谓的增材工艺的制造提供，因为这些工艺可以直接成型并且没有工具成本。
然而，通过所谓的浆料挤出机直接3D打印LSR材料会导致产品分辨率低。LSR材料的组分A和B通常在排放前直接在静态混合管中在压力下混合，并通过三轴计算机控制的入口沉积。高粘度会阻止打印过程中的精细分辨率。各个层在较低的毫米范围内清晰可见。在这种情况下，硫化通过热空气或红外线辐射的热量输入逐层进行。
由于粘度太高，无法通过立体光刻(SLA)直接3D打印UV可固化的液态有机硅。可用的UV可固化的低粘度有机硅不具有生物相容性，或者不能同时表现出适合3D打印所需的机械特性。此外，有机硅化学的理论考虑揭示了粘度和机械性能之间的矛盾。由于预聚物较短，在非交联状态下具有低粘度的聚硅氧烷同时在交联状态下具有较低的机械性能。
因此，不可能借助增材制造由有机硅生产出具有高表面质量的生物相容、医学上适宜的且可承受机械力的植入物，此外其可以经济地以批量形式生产。
现有技术包括出版物Sereno，L.等人，"New advances on tracheal stentmanufacturing"，第6届IFAC生产和物流管理与控制会议，国际自动控制联合会，9月11-13日，2013年巴西Fortaleza，第344-349页。公开了从生物相容性有机硅生产有机硅支架的各种生产方法。通过增材制造从ABS材料生产成型工具。注入的有机硅在180℃下硫化5分钟。没有进一步研究确定植入物的生物相容性或化学纯度是否在与ABS材料接触后仍保持不变。
因此，本发明的目的是提供一种由有机硅生产具有高表面质量的生物相容、医学上适宜、可承受机械力的植入物的方法，其中该方法即使在极少件数的情况下比已知的生产方法在经济上更有利。
该目的通过具有专利权利要求1的特征的方法来实现。
本发明的有利改进在从属权利要求中阐述。
根据本发明的用于由生物相容性有机硅生产植入物，特别是长期植入物的方法通过以下步骤进行：
a)提供待生产的植入物的3D数学模型；
b)借助植入物的3D模型，创建植入物铸模的3D模型作为模具(Negativ)；
c)所述铸模由聚合物材料通过增材制造工艺制成；
d)至少在与待浇铸的有机硅接触的区域对所述铸模进行涂层；
e)所述涂层是借助聚对二甲苯类涂层材料的气相沉积进行的；
f)将生物相容性有机硅引入经涂层的铸模的模腔中；
g)加热所述铸模，使所述有机硅硫化；
h)经硫化的植入物在冷却后从铸模中脱模。
所述植入物尤其涉及长期植入物。术语长期还表示在体内的停留时间超过29天。所述植入物尤其是支架。
根据本发明的方法使用间接3D打印。在间接3D打印中，组件(即植入物)不是增材制造的，而是可以形成植入物的铸模。3D打印工艺的局限性在于，必须找到一种工艺和材料，其具有足够的稳定性来制作适宜的有机硅的模型，同时具有高打印分辨率以产生光滑的表面，并且还可以承受用于硫化有机硅一段时间的温度。此外，在成型过程和硫化过程中，不允许任何成分从铸模迁移到植入物中。最后，经硫化的植入物在硫化后必须能够在不被过度用力损坏的情况下脱模。
根据本发明的方法基于，首先提供待生产的植入物的3D数学模型。3D模型展示根据本发明的方法的输入信息。特别地，3D模型可以从先前已经从成像数据中获得的支架的生物实体模型(Volumenmodell)导出，所述成像数据例如，计算机断层扫描或磁共振成像，或其他3D数据，例如从3D扫描。
可以修改从成像数据中获得的实体模型(特别是支架)的轮廓，以实现治疗效果。为此目的，应用医学专业知识来确保可以在不产生负面副作用(例如坏死)的情况下实现所需的治疗效果。
根据本发明的用于生产植入物的方法涉及从待制造的植入物的现有数据出发的生产过程本身，而与这些数据是否以及如何先前已经获得、修改或处理无关。
从植入物的3D模型出发，即从植入物的阳模开始，以植入物铸模的3D模型的形式创建虚拟阴模。铸模可以是单部分或多部分的，以允许植入物成品的脱模。铸模包括用于待生产的植入物的模腔。模腔配有用于浇铸有机硅所需的连接，例如浇道或冒口。
实际的铸模是通过增材制造工艺生产的，即通过所谓的3D打印工艺，例如立体光刻或所谓的材料喷射。可以使用相对较低的层厚度进行打印，从而可以实现高打印分辨率和非常好的表面光洁度，这对于医疗应用，特别是对于此处涉及的植入物而言是必不可少的。增材制造的层厚最大为50μm，最好不要超过25μm。应使用足够的温度稳定的打印树脂作为铸模的材料。特别地，打印树脂随后应该是可后固化的，以达到硫化有机硅所需的热稳定性，并进一步满足铸模的机械性能。本发明允许铸模能够由非生物相容的聚合物制成。如果生物相容性聚合物可用，则根据本发明的方法也能够将生物相容性聚合物用于铸模。
聚合物材料的铸模被涂层。该涂层旨在防止成分在成型过程或硫化过程中从铸模迁移到有机硅或植入物中。因此，至少与待浇铸的有机硅接触的区域被涂覆，但特别是整个铸模。因此，应创建扩散屏障，这才根本地允许对铸模使用非生物相容性材料，并因此为增材制造工艺铺平道路。
所述涂层借助气相沉积施加，即使用CVD工艺。聚对二甲苯家族的聚合物已被证明适合作为涂层材料。聚对二甲苯是指一组惰性、疏水、光学透明的聚合物涂层材料。聚对二甲苯的CVD沉积主要涉及在真空下蒸发预聚物(二聚体)，随后将蒸发的二聚体热解成单体，最后是在铸模的冷表面上涂层(聚对二甲苯)的缩合和聚合。由于气态沉积和高间隙穿透能力，还可以达到并涂层不能用基于液体的工艺涂层的区域和结构，例如，锋利的边缘和尖端或窄而深的间隙。在一次操作中可以施加0.1至10μm的涂层厚度。从0.6μm涂层厚度起，涂层没有微孔和针孔。涂层还具有使铸模表面在经涂层的区域中平滑的优点。优选地，所述涂层在大于1μm的范围内，并优选在1至10μm的范围内，特别是在3至7μm的范围内。
在涂层之后，将铸模准备好达到可以将生物相容性有机硅引入到经涂层的模具的模腔中的程度。这优选通过浇口在压力下实施。在这种情况下，涉及在间接3D打印使用下的注塑成型过程。随即有机硅必须交联，即硫化。为此，铸模被加热。冷却后，经硫化的植入物从铸模中脱模并转移以供进一步使用。
优选地，该方法用于生产支架，特别是气管-支气管支架，作为植入物。当这种个体定制的气管-支气管支架以件数生产时，该生产在经济上也是有利的。无需生产复杂的金属注塑模具，这将导致小量件数生产成本高昂。
由于气管-支气管支架以系列组件的形式存在，存在系列组件的构造知识，其也已经考虑了治疗效果，并以产生尽可能少的负面副作用的方式进行设计。在根据本发明的方法中，可以使用这些已知信息，从而可以将植入物的3D模型放置在CAD系统中作为在虚拟块即铸模中的阴模，并且可以通过布尔运算提取。这样在块中产生的型腔是后来的模具型腔。然后设计块，特别是设计成几个部分，以便能够从后来的铸模中取出铸造植入物。为此，铸模可以具有至少一个第一半模、至少一个第二半模和至少一个型芯，其中所有这些部件在根据本发明的方法中增材制造。此外，还有注塑成型的典型模块，例如浇口、通风口和其他功能面，例如模具零件的定心和相互固定。
以这种方式构建的铸模的各个组件以立体光刻文件格式从CAD系统导出，并准备在适合预期3D打印的切片机软件中进行3D打印。在这个阶段，也可以考虑组件可能的收缩作为加工余量。
特别地，UV-可固化树脂用作铸模的材料。使用UV-可固化树脂允许铸模具有必要的型稳定性以及随后的硫化所需的热稳定性。分别根据制造商对UV-可固化树脂的规格，可以分几个阶段进行紫外线固化(后固化)，以确保铸模的热稳定性。例如，铸模或铸模的一部分的UV固化可以在至少三个阶段中进行，其中第一阶段不低于60℃的温度被设定持续至少60分钟的保持时间。在随后的第二阶段中，不低于80℃的温度被设定持续至少60分钟的保持时间，并且在随后的第三阶段中，不低于120℃的温度被设定持续至少120分钟的保持时间。在固化之前，3D打印的组件被打印典型的支持材料解放和清洁。所述清洁尤其可以通过在异丙醇中洗涤至少10分钟并随后干燥来实施。然后在紫外线辐射和加热下开始后固化。
优选地，如此产生的铸模在进一步加工之前通过等离子清洁工艺进行清洁。氧等离子蚀刻可以在此应用，其同时也增加了聚对二甲苯的附着力。例如，铸模可以在真空中用氧等离子体清洁至少3分钟。
可以通过硅烷化进行进一步的预处理。硅烷化也称为硅涂层工艺。优选地，硅烷基团通过所谓的前体在真空工艺中沉积。液态硅烷由此蒸发并通过冷凝沉积在部件的表面上，从而形成粘附基底。
随后使用聚对二甲苯家族的聚合物进行实际涂层。特别是，聚对二甲苯C是通过CVD工艺沉积的。优选地，聚对二甲苯C层的厚度为至少1μm，特别是至少5μm。优选地，层厚度在1和10μm之间的范围内。聚对二甲苯具有防扩散的特性。它们形成闭孔薄膜。根据本发明，扩散屏障和闭孔结构允许用有机硅制造植入物，有害物质不会从铸模扩散到其中。聚对二甲苯C具有必要的物理特性，并且对水分和气体的渗透性极低。
然后在进一步加工之前检查以这种方式涂层的铸模，任选地再次清洁，并且组装铸模的组件以形成完成的铸模。多组件式铸模可以例如通过将铸模的各部分用螺栓连接在一起来组装，从而在相关的成型区域中以压力密封的方式封闭模腔。模腔的闭合或半模的连接可以通过螺钉实现。也可以考虑将半模夹在一起，例如在压力机中。
随后，在压力下使用经混合的可植入的医用有机硅，特别是医学认可的铂催化2K硅胶，例如Nusil MED-4870(Nusil是Nusil Techology,LLC的注册商标)被引入铸模的模腔中。有机硅的引入，特别是在压力下的注入，也可以在预热的工具中实施。当有机硅开始从至少一个连接到模腔的排气口中逸出时，填充过程就完成了。随即将如此引入的有机硅硫化，特别是在120℃至180℃下，每毫米植入物壁厚持续10秒。优选地，铸模或由铸模形成的空腔被加热到至少140℃的温度，持续至少10秒/毫米植入物壁厚。为此，可以将整个铸模放入烘箱中并在140℃下加热，直到内部温度达到140℃。模腔中的温度可以通过设置在至少一个型芯中的至少一个温度传感器来测量。由于型芯被工件包围，因此型芯中的温度可以得出关于模具型腔温度的结论。支架的优选壁厚范围为0.5毫米至3毫米。
可以使用热空气和/或红外辐射来加热铸模以硫化有机硅。硫化直到所有有机硅(即所有厚度范围)都已硫化为止，这一点至关重要。
冷却后打开铸模，使植入物脱模。然后有机硅组件可以进行机械后处理，例如通过去除浇道锥、冒口、粘附网(anhaftende
Figure BDA0003653233390000091
)和植入物的其他不需要的部分。然后可以对植入物进行清洁并任选地涂层，例如通过浸涂，以实现所需的表面质量。植入物的成型制造步骤现已完成。
为了进一步使用，植入物优选地包装在允许消毒和防止污染的合适的可热封膜中。特别是，为此目的使用了由Tyvek(Tyvek是E.I.Du Pont de Nemours and Co.的注册商标)制成的袋子，植入物被包装并热封在袋子中。这之后是消毒过程，其中所述消毒可以例如借助蒸汽、ETO或过氧化氢等离子进行。
根据本发明的方法能够由有机硅生产具有高表面质量的生物相容、医学上适宜且可承受机械力的植入物，并且与其他已知的生产方法相比，即使在非常少量件数的情况下也可以更经济地生产。特别是，可以在不影响生物相容性的情况下使用立体光刻技术或材料喷射技术。所涉及的植入物符合ISO 10993标准对溶质和物质的理化测试和分析要求，并符合可溶出物质的限制。已经证明了对于液态有机硅的脱模允许足够稳定性的工艺和使用。由于打印分辨率高，成品表面光滑，其中通过借助聚对二甲苯的后续CVD涂层进一步减少了表面不规则性。此外，涂层可防止成分从铸模迁移到组件中，从而可以满足相关标准。

Claims (17)

1.由生物相容性有机硅生产植入物的方法，其包括以下步骤：
a)提供待生产的植入物的3D数学模型；
b)借助植入物的3D模型，创建植入物铸模的3D模型作为阴模；
c)所述铸模由聚合物材料通过增材制造工艺制成；
d)至少在与待浇铸的有机硅接触的区域对所述铸模进行涂层；
e)所述涂层是借助聚对二甲苯类涂层材料的气相沉积进行的；
f)将生物相容性有机硅引入经涂层的铸模的模腔中；
g)加热所述铸模，使所述有机硅硫化；
h)经硫化的植入物在冷却后从铸模中脱模。
2.根据权利要求1所述的方法，其特征在于，所述铸模由非生物相容性材料制成。
3.根据权利要求1或2所述的方法，其特征在于，借助该方法将支架，特别是气管-支气管支架生产成植入物。
4.根据权利要求1至3中任一项所述的方法，其特征在于，用于铸模的3D模型被构造成多个部分，以便能够从铸模中取出所浇铸的植入物。
5.根据权利要求4所述的方法，其特征在于，增材制造至少一个第一半模、至少一个第二半模和至少一个芯用于所述铸模。
6.根据权利要求1至5中任一项所述的方法，其特征在于，使用UV可固化的树脂作为铸模的材料，其中在3D打印后清洗铸模或其部分，并在一个或多个温度阶段中进行UV固化。
7.根据权利要求6所述的方法，其特征在于，铸模的所述UV固化在至少三个阶段中进行，其中在第一阶段中，不低于60℃的温度被设定持续至少60分钟的保持时间，其中在随后的第二阶段中，不低于80℃的温度被设定持续至少60分钟的保持时间，并且其中在随后的第三阶段中，不低于120℃的温度被设定持续至少120分钟的保持时间。
8.根据权利要求1至7中任一项所述的方法，其特征在于，在所述涂层之前用等离子清洗工艺清洗所述铸模。
9.根据权利要求1至8中任一项所述的方法，其特征在于，经清洗的铸模在涂层之前被硅烷化。
10.根据权利要求1至9中任一项所述的方法，其特征在于，所述涂层以至少1μm的厚度施加。
11.根据权利要求1至10中任一项所述的方法，其特征在于，所述硫化在120℃至180℃下进行，持续时间为每毫米植入物壁厚至少10秒。
12.根据权利要求1至11中任一项所述的方法，其特征在于，将有机硅引入铸模之后加热铸模，直至在铸模的模腔中达到至少140℃的温度，持续时间为每毫米植入物壁厚至少10秒。
13.根据权利要求5至12中任一项所述的方法，其特征在于，在模腔中的温度通过布置在至少一个型芯中的至少一个温度传感器来测量。
14.根据权利要求1至13中任一项所述的方法，其特征在于，用于硫化有机硅的铸模的加热是借助热空气和/或IR辐射进行的。
15.根据权利要求1至14中任一项所述的方法，其特征在于，使用铂催化的2-组分热固性有机硅作为植入物的材料。
16.根据权利要求1至15中任一项所述的方法，其特征在于，将植入物成品放置在允许消毒并防止污染的可热封膜中。
17.根据权利要求1至16中任一项所述的方法，其特征在于，植入物成品借助蒸汽、ETO或H2O2等离子体进行消毒。
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