CN102176883A - 具有离散固着表面的软填充假体外壳 - Google Patents

具有离散固着表面的软填充假体外壳 Download PDF

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CN102176883A
CN102176883A CN2009801402841A CN200980140284A CN102176883A CN 102176883 A CN102176883 A CN 102176883A CN 2009801402841 A CN2009801402841 A CN 2009801402841A CN 200980140284 A CN200980140284 A CN 200980140284A CN 102176883 A CN102176883 A CN 102176883A
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D·E·范爱普斯
T·E·鲍威尔
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Allergan Inc
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
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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
    • A61F2250/0014—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
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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
    • A61F2250/0014—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
    • A61F2250/0026—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 surface structures
    • 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
    • A61F2250/0014—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
    • B—PERFORMING OPERATIONS; TRANSPORTING
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Abstract

其上具有用于组织附着的离散固着表面的软假体植入物外壳，如硅氧烷乳房植入物外壳。所述固着表面(22、24)可位于所述外壳的后表面上，以及边缘上或在前表面的离散区域上。带状固着表面可位于所述外壳的前表面上以与胸大肌群或胸小肌群的角度基本一致。所述固着表面可以是所述外壳的粗糙化区域，或者可以是附着在所述外壳上的独立元件。

Description

具有离散固着表面的软填充假体外壳
相关专利申请的交叉引用
本申请要求享有2008年8月13日提交的美国临时专利申请系列号61/088,418的权益，该专利申请以具体引用的方式全文纳入本说明书。
技术领域
本发明涉及软假体植入物，并且更具体地涉及这样的植入物——例如乳房植入物——的织纹状(textured)外表面。
背景技术
可植入假体一般用于代替或增填身体组织。在乳癌的情况下，有时需要除去部分或全部乳腺和周围组织，这造成可由可植入假体填充的空洞。所述植入物用于支持周围组织和保持身体外观。正常身体外观的修复对术后患者有非常有益的心理影响，它能消除通常在大量手术操作后出现的很多震惊和沮丧。可植入假体还更普遍地用于修复身体多个部位——例如臀部、颏、腓肠等的软组织的正常外观。
可植入软假体一般包括由硫化(固化)硅氧烷弹性体制成的较薄且柔韧的外层或外壳。所述外壳可用硅氧烷凝胶或生理盐溶液填充。在将所述外壳通过患者的切口插入之前或之后对所述外壳进行填充。
在美国，女性可选择两种不同类型的乳房植入物外壳表面：光滑表面和织纹状表面。外科医生一般根据其技术和所选择乳房植入物的形状来推荐表面的类型，以最好地满足每位患者的需求。
乳房植入物也会发生并发症，其中一种被称为包膜挛缩(capsular contracture)。这是一种在植入物周围形成的纤维性外层包膜挛缩时发生的并发症，其趋于使植入物变成球形、僵硬，并且不美观。根据美国食品和药物管理局(FDA)乳房植入物消费者手册(2004)，表明织纹状表面乳房植入物可降低包膜挛缩的发生率。
织纹化(texturing)可由多种方法提供。被织纹状聚氨酯泡沫薄层覆盖的硅氧烷凝胶乳房植入物由于它们对早期形成的纤维性包膜挛缩的显著抗性而在二十世纪80年代大受欢迎。例如，美国专利No.3,293,663描述了一种背面为多孔聚酯纤维的凝胶填充的软假体，所述多孔聚酯纤维用于组织向内生长和锚固于胸壁。尽管由于管制这些装置在美国已经不再可用，但是它们的医学和商业成功激起了对硅氧烷植入物的表面织纹化(texturization)的兴趣。
尽管在安全并且舒适的假体植入物的开发中取得了很多进步，然而仍有改进的空间。
发明内容
本发明提供适于植入人的假体，例如，适合修复或增填人乳房的乳房植入物。所述假体一般包括可植入部件，例如，填充有或可填充液体或凝胶的弹性体外壳。所述可植入部件具有包括上面界定有一个或多个固着区域的外表面，所述固着区域被装配、放置或构造以提供增强的或受控的组织向内生长或附着。
根据本发明的一个方面，所述固着表面是延伸穿过植入物的前表面或后表面的离散的、大致为细长形的表面部分。这些固着表面——在本文中有时被称作“固着区域”——一般由与所述植入物的邻近表面部分的织纹、粗糙度或光泽不同的织纹、粗糙度或光泽界定。
在某些实施方案中，所述固着区域具有相对于所述植入物的前表面或后表面的剩余部分更多或更强的织纹。换言之，外表面的剩余部分可比所述固着区域的织纹化程度轻。在某些实施方案中，所述固着区域为织纹状，而邻近表面例如不由所述固着区域界定的一块或多块表面的织纹状程度显著较低，或较平滑。
所述假体可被构造为：相对于没有这样的织纹、粗糙度或光泽的在其它方面相同的表面，促进组织在所述固定区域增强的向内生长或附着。
在本发明的一个方面，所述固着区域被放置和/或装配使得假体在植入身体后更自然地随人体移动，例如，与身体肌肉共同移动。可以想到由于所述植入物更自然地随人体移动，因此与常规植入物例如没有这样的固着区域的植入物相比，所述植入物可能更不易于因材料应力而磨损。此外，可以想到本发明的植入物对于患者来说将更加舒适，因为它们可以更自然地随人体移动。
在本发明的一个更具体的方面，所述固着表面可位于外壳前表面——即当所述植入物被适当地植入人体中时朝向人体前面的外壳表面——的特定区域。或者或此外，可在外壳的边缘(例如圆周)和/或外壳的后表面——即当所述植入物被植入人体中时朝向人体背部的外壳的表面——上提供一个或多个离散固着表面。
在本发明的一个甚至更具体的方面，所述固着区域包括至少一个位于所述外壳前表面的细长形区域。所述至少一个细长形区域可以是，例如，具有增强的织纹、粗糙度或光泽的一个带状区域或者多个带状区域。
当植入物被植入人体时，可使所述细长形固着区域的位置与人体的胸大肌群或胸小肌群之一对齐。例如，在本发明的一个实施方案中，当所述植入物被植入人体时，所述至少一个细长形区域包括意图与胸大肌群对齐的径斜放置的带状区域。在另一个实施方案中，所述至少一个固着区域包括大致与胸小肌群——所述植入物已在此处植入体内——位置相同的辐射状构型的多个细长形区域。
在本发明的另一个宽泛方面，所述假体包括具有外壳的乳房植入物，所述外壳包含具有第一织纹的固着区域以及具有与所述第一织纹不同的第二织纹的剩余外壳表面。换言之，在本发明的一些实施方案中，所述乳房植入物外壳的全部或者基本全部外表面是织纹状表面，所述织纹状表面的特定区域相对于所述织纹状表面的剩余部分具有更大程度的织纹化。
可以想到，这样不同程度的织纹化将刺激或促进组织在不同固着区域的不同程度的向内生长或附着。例如，在一个实施方案中，第一固着区域位于所述植入物的后表面，而第二固着区域位于所述植入物的前表面。所述第一固着区域可由更有助于组织相互作用和附着的织纹界定，而所述第二固着区域可由对组织相互作用和附着的促进作用较弱的织纹界定。
在本发明的又另一个方面，所述假体包括具有被构造以与组织接触的外表面的外壳，所述外壳包括具有第一开放小室(open cell)结构的第一固着表面和具有与所述第一开放小室结构不同的第二开放小室结构的第二固着表面。此外，所述第一固着表面和所述第二固着表面被放置以促进身体在身体-外壳接触面处各自不同程度的组织向内生长或组织附着。
例如，所述第一开放小室结构包含较大的开放小室，而所述第二开放小室结构包含较小的开放小室。或者或此外，所述第一开放小室结构可包含第一小室分布，而所述第二开放小室结构包含第二小室分布，其中所述第一小室分布比所述第二小室分布更密集。
在本发明的又另一个具体方面，所述第一开放小室结构包含较大的圆形开放小室，而所述第二开放小室结构包含较小的圆形开放小室。或者，所述第一开放小室结构包含较圆的开放小室，而所述第二开放小室包含相对有棱角的开放小室。
根据一些实施方案，所述第一和第二固着表面被有利地放置和构造以在假体被植入身体后至少在某种程度上有效地破坏或干扰假体周围包膜组织的形成。
本发明还提供用于植入人的乳房假体外壳，所述外壳通过以下步骤制造：提供外壳前体；将硅氧烷弹性体层涂覆于所述外壳前体，将第一种构型的固体颗粒涂覆到所述硅氧烷弹性体层的一部分，并且将第二种构型的固体颗粒涂覆到所述硅氧烷弹性体的另一部分，然后将所述涂层完全地固化。在包含包埋在其中的固体颗粒的所述涂层固化后，将所述固体颗粒例如用溶剂溶解，所述溶剂不会以任何可察觉的程度溶解所述硅氧烷弹性体。得到的弹性体外壳包含第一开放小室织纹区域和第二开放小室织纹区域，所述第一开放小室织纹区域通过所述的第一种构型的固体颗粒的涂覆形成，所述第二开放小室织纹区域通过所述的第二种构型的固体颗粒的涂覆形成。
在本发明的另一个方面，提供增填或修复人乳房的方法。所述方法主要包括：提供可植入构件，所述可植入构件包括至少一个如本文他处描述的细长形固着区域；并且将所述可植入构件植入人乳房，以使所述固着区域与胸大肌群和胸小肌群的之一基本对齐。所述方法还可包括在植入步骤之前或之后用液体或凝胶填充所述可植入构件。
在以下的说明书和权利要求中——特别是当与附图结合考虑时——将详细解释对本发明的特性和优点的进一步理解，在所述附图中相同的部分具有相同的参考数字。
附图说明
参考说明书、权利要求和附图可以更好地理解本发明从而领会本发明的特性和优点，所述附图中：
图1A-1B分别是本发明的示例性圆形乳房植入物的前视图和侧立视图；
图2A-2B分别是本发明的示例性有形乳房植入物的前视图和侧立视图；
图3A和3B是分别显示胸大肌群和胸小肌群排布的女性上躯干示意图；
图4A和4B是分别显示乳房植入物的腺体下和肌肉下放置的穿过女性乳房和邻近胸部解剖结构的垂直截面图；
图5A-5B是具有大致为细长形或带状的固着表面的本发明示例性圆形乳房植入物的前视图和侧立视图；
图6A-6B是具有大致为细长形或带状的固着表面的本发明示例性有形乳房植入物的前视图和侧立视图；
图7是本发明的另一种乳房植入物的前立视图，所述植入物包括具有第一织纹的第一固着区域和具有与所述第一织纹不同的第二织纹的第二固着区域。
图8A和8B是本发明的示例性圆形乳房植入物的前立视图和后立视图，所述乳房植入物具有互不相同的前织纹和后织纹。
具体实施方式
本发明提供在外部具有固着表面的盐水或凝胶填充的软植入物外壳，优选硅氧烷弹性体外壳。这样的软植入物的主要应用是修复或增填女性乳房。其他可能的应用是臀部、睾丸、腓肠等部位的植入物。
本文使用的术语“固着表面”或“固着区域”一般指植入物的外表面的一个区域或部分，所述区域或部分被放置、构造或改造以促进在身体/植入物界面处的组织向内生长或附着。例如，固着区域可具有与所述植入物的邻近表面(其不能与所述固着区域同样程度地促进组织向内生长或附着)不同(例如比邻近表面更显眼)的织纹、粗糙度或光泽。例如，所述植入物外表面的其他区域或表面与所述固着区域相比可较光滑或织纹状程度较低。
这样的固着区域可通过任意合适的方法形成，例如但不局限于比如适当更改的在美国专利No.5,007,929中所描述的脱盐法。或者，所述固着表面可由独立的织纹状元件例如附着在原本“光滑”或织纹状程度较低的植入物外面的织纹状补片或薄膜形成。此外，形成所述离散固着区域的另一种方法可以通过使用用于形成所述植入物的模具的较粗糙表面部分。形成本发明的固着区域的另一种方法包括在所述植入物形成后将其外表面织纹化。不应认为本发明受限于任何具体类型的织纹状表面或固着表面，尽管采用一种或多种这些技术可能有某些优点。
现在转向附图，图1A和1B是本发明的示例性圆形乳房植入物20的前立视图和侧立视图。植入物20主要包括由较光滑前表面21、织纹状后表面22和位于前表面21和后表面22之间的织纹状边缘区域24界定的外表面。所述较光滑的前表面可以是织纹化程度较低的表面(相对于后表面22的织纹)，例如，细织纹状表面甚或亚光面(matte finish)。在一些实施方案中，植入物20有较光滑的后表面，织纹状前表面以及织纹状的或光滑的边缘区域。固着表面22、24本身可能有不同程度的织纹化。所述植入物的直径D和前后厚度T被示出并且根据患者的胸部尺寸和审美考虑而变化。
在显示的实施方案中，后固着表面22延伸至植入物20的顶端26或凸外边缘的母线。边缘固着表面24向前延伸一段短的距离S至前表面21。在一些实施方案中，所述距离S是厚度T的约10％至约30％。在一些实施方案中，边缘固着表面24基本上完全地围绕植入物20的边缘延伸，从而使植入物20轴对称。在其他实施方案中，可缩减边缘固着表面24从而仅围绕所述植入物的边缘的一部分如下半部或上半部延伸，或者所述边缘固着表面可分为间隔开的区段。在一些实施方案中，边缘固着表面24包括基本上相等间隔的区段，产生交替的光滑和织纹状区域。
图2A-2B描绘了具有模拟天然乳房的前下叶32的示例性有形乳房植入物30。像植入物20一样，植入物30包括后固着表面34和边缘固着表面36。所述植入物的宽度W、高度H和前后厚度T被示出。若正面投影是圆形，则W＝H，否则W可以大于或小于H。当以天然形状提供时，植入物30有适当的取向，即下叶32在靠下的中心处。因此，边缘固着表面36可完全地围绕所述植入物的边缘延伸，或可在离散区域形成，并且相对于所述植入物的自然形状取向。例如，边缘固着表面36可仅围绕所述植入物的下半部形成，或仅在侧面形成。
图3A描绘了示意性显示一侧胸大肌群的位置和排布的女性上躯干，而图3B描绘了胸小肌群的位置和排布。这两个肌群部分重叠并且大致从肩膀或锁骨区域延伸至乳房下的肋廓。本发明的一方面是提供包括如本发明他处所描述的固着表面的植入物，当所述植入物被放置在身体中时，所述固定表面与这些肌群基本对齐。
不意欲囿于任何具体的操作理论，所述植入物和主要胸部肌肉的接触区域或接触线比所述植入物不与肌肉接触的其他区域经历更多的运动。发明人相信通过提供与这些肌群的一个或多个基本一致或基本对齐的所述植入物的固着区域，更可能保持牢固(即，它们随肌肉运动)。此外，可想到这样的离散固着区域可提供破坏包膜形成和/或降低包膜挛缩的可能性的益处。
图4A是显示乳房植入物40的腺体下放置的穿过女性乳房和邻近胸部解剖结构的垂直截面图。植入物40被放置在胸大肌群42的顶部上，而胸大肌群42覆盖在胸小肌群44上。显示出多根肋骨50的胸壁48也被指明在胸小肌44的下面。图4B是同图4A的垂直截面图，但显示的是植入物40在胸大肌群42下面的肌肉下放置。这两种植入物放置的使用都主要取决于外科医生的临床决定，有时还受到患者和外科医生之间的对话以及所需结果的影响。取决于植入物放置，植入物40可以与所述肌群之一或两者接触。在本发明的一些实施方案中，所述植入物包括如本文所描述和显示的大致为细长形的固着区域，并且所述固着区域与合适的肌群基本对齐，当所述植入物被放置于身体中时所述肌群与植入物接触。
例如，图5A-5B是本发明示例性圆形乳房植入物60的前立视图和侧立视图，所述植入物60有后表面62、边缘区域64和包括细长形或带状的固着区域66的前表面。所述带状固着区域66基本上沿对角线延伸并且开始于边缘固着区域64的前边界。在绘出的实施方案中，固着区域66具有如在图5A的前视图中所见的基本恒定的宽度W。在一个实施方案中，所述宽度W为约1mm至约20mm，例如，约2mm至约15mm。或者，尽管没有示出，固着区域66可具有非恒定宽度的构型。
在一个实施方案中，当所述植入物被植入乳房时，带状固着表面66通常以胸大肌群或胸小肌群确定或与之对齐。例如，若植入物60预定进行如图4B中的肌肉下放置，那么可以确定固着表面66的取向以与胸大肌群大致对齐，如图3A所示。或者，插入表面66的取向角度可以是胸大肌群和胸小肌群平均角度的近似值。这样，植入物60具有固着表面66以促使组织沿植入物的主应力线向内生长或附着。固着表面66相对于穿过植入物60的垂直面的角度优选地为约30-60°。当然，若植入物60为所示的圆形，那么固着表面66本身确定其取向。在一个实施方案中，带状固着表面66以植入物60的中央为中心，因此形成相隔约180°的两个对称的方向。这种排布通过为外科医生提供两个可能的方向而方便了植入。
带状固着区域66可基本延伸穿过植入物的前表面并且可由与前表面的剩余部分不同的织纹界定。固着区域66还可具有不同的织纹，例如，比后固着表面66或边缘表面64更显眼或更粗糙的织纹。
图6A-6B描绘了本发明另一种示例性有形乳房植入物70。植入物70也以后固着表面72、边缘固着表面74和多个分离的带状固着表面76a、76b、76c为特征。这些离散固着表面76a、76b、76c被放置或装配以与一个或多个上述肌群对齐。例如，所述3个固着表面76a、76b、76c可基本上相对于扇形的胸小肌群取向。由于有形植入物70具有特定取向，所述植入物的适当放置使固着表面76a、76b、76c以具体肌肉群取向。如上所述，多个固着表面72、74、76a、76b、76c可以以相似水平的粗糙度形成，或者其中一些的织纹化程度可能较低，例如具有亚光面。例如，后固着表面和边缘固着表面72、74可具有细亚光面，而前固着表面76a、76b、76c具有更密集的织纹。本发明考虑到了织纹化选择的所有排列。
在横截面中，本发明的织纹状植入物外壳可以是单层或多层的。所述织纹状植入物外壳壁的总厚度可由于额外的织纹层而以某种程度大于类似的光滑壁外壳。
现在转向图7，其以110大致显示了本发明的另一种乳房植入物的前视图。植入物110包括具有外表面的外壳112，所述外表面包括具有第一织纹116的第一固着区域114和具有与第一织纹116不同的第二织纹122的第二固着区域118。在所显示的实施方案中，第一织纹116是比第二织纹122更“有攻击性”的织纹。第一织纹116被构造以比第二织纹122更大程度地促进组织相互作用。
代替第二织纹122，可想到第二固着区域118并且可能所述外壳112的全部剩余外面是低光泽表面，例如，亚光面。
现在转向图8A和8B，其以210分别大致显示本发明的另一种乳房植入物的前视图和后视图。植入物210包括具有前表面212a和后表面212b的外壳212，所述外壳还包括具有第一织纹216的第一固着区域214和具有与第一织纹216不同的第二织纹222的第二固着区域218。在所示的实施方案中，第一织纹216可覆盖植入物210的全部或基本上全部的前表面212a。第一织纹216由比第二织纹222稀疏的孔、隙或洞的第一分布界定。第二织纹222可覆盖植入物210的全部或基本上全部的后表面221b，其可被构造以比第一织纹216更大程度地促进组织相互作用和附着。
可通过本发明的方法制造外壳112和212，所述方法包括以下步骤：提供外壳前体；将硅氧烷弹性体层涂覆于所述外壳前体，将第一种构型的固体颗粒涂覆到所述硅氧烷弹性体层的一部分并且将第二种构型的固体颗粒涂覆到所述硅氧烷弹性体的另一部分，然后进行完全地固化。在包含包埋在其中的固体颗粒的所述涂层固化后，将所述固体颗粒例如用溶剂溶解，所述溶剂不会以任何可察觉的程度溶解所述硅氧烷弹性体。得到的弹性体外壳包含第一开放小室织纹区域和第二开放小室织纹区域，所述第一开放小室织纹区域通过所述的第一种构型的固体颗粒的涂覆形成，所述第二开放小室织纹区域通过所述的第二种构型的固体颗粒的涂覆形成。
形成可植入假体的柔韧的植入物外壳的一种方法包括将合适形状的模芯(mandrel)浸渍在硅氧烷弹性体分散液中。在本领域中使用很多这样的分散液。它们主要包含硅氧烷弹性体和溶剂。所述硅氧烷弹性体一般是聚二甲基硅氧烷、聚二苯基硅氧烷或这两者的某种结合物。一般的溶剂包括二甲苯或1，1，1-三氯乙烷。不同的制造商改变分散液中成分的类型和量、分散液的粘度和分散液的固体含量。但是，预计本发明可适合于利用多种硅氧烷橡胶分散液。
将所述模芯从分散液中取出并使多余的硅氧烷弹性体分散液从所述模芯上流尽。所述多余的分散液从所述模芯上流尽后，使至少一部分溶剂挥发或蒸发。通常这通过在受控的温度和湿度下让空气流过被包覆的模芯来完成。不同的制造商使用不同量、速度或方向的气流并将空气的温度和湿度设置为不同的值。但是，所需的结果是一样的，都是除去溶剂。
假体制造商常常将此浸渍和挥发步骤重复多次以在所述模芯上形成很多层来达到所需的外壳厚度。分层结构如大部分现有硅氧烷弹性体外壳可通过依次在不同的分散液中浸渍所述模芯来制造。或者，可在单一分散液中重复上述步骤从而使成品是单一同质的材料或层。也就是说，所述浸渍方法可在多个阶段或多个步骤中完成，每个步骤加入更多的材料，但是所述成品不会呈现不同的层并且整个外壳壁在组成上是同质或均质的。
现在将描述在多层外壳或单层外壳上形成所述固着表面的示例性方法。当其上附着有将成为最终层的物质的模芯从分散液中取出后，稳固该层。也就是说，搁置该模芯，直到所述最终涂层不再自由流动。这种情况的发生是由于一些溶剂从所述最终涂层中蒸发，升高了其粘度。
此外，应理解也考虑到了在织纹化过程之前形成柔韧外壳的可选方法。所述浸渍模塑法有利地形成预先安装在浸渍模芯上的柔韧外壳，所述外壳随后可被用于织纹化过程。但是，如果所述柔韧外壳是通过其他技术制造的，例如通过旋转模塑制造，那么随后可将它安装在浸渍模芯上并且以相同的方式继续所述过程。
一旦所述柔韧外壳已被稳固并安装在所述模芯上，就用例如抗静电空气喷枪将任何松脱的纤维或颗粒从所述外壳的外面除去。然后涂覆一层粘性涂层。所述粘性涂层可以喷涂上去，但是理想的是通过将所述模芯上的柔韧外壳浸渍在粘性涂料分散液中进行涂覆。操作者将所述柔韧外壳浸入所述分散液中然后将模芯放回到搁架上进行稳固。稳固所需的时间一般为5-20分钟。合适的粘性涂层理想的是使用与在基层中使用的相同材料制造。
此时，将颗粒状的固体颗粒(即，盐晶体)涂覆在外表面最终将成为所述固着表面的部分上。所述固体颗粒可通过在操作所述模芯的同时将其撒在表面来手动涂覆，或者可使用如喷粒机(bead blaster)或喷砂机那样作业的机器来以足够的速度向模芯上的涂层递送稳定的固体颗粒流。但是，固体颗粒涂覆的一种优选方法是将所述模芯/外壳浸渍到大量固体颗粒中或者将其暴露在固体颗粒的悬浮液中。应理解本发明不意欲局限于任何一种具体的涂覆颗粒的方法，但是必须注意确保所述固体颗粒仅附着于所需区域。向所述外壳的一部分而不是全部涂覆固体颗粒的一种可能的方法是将不要涂覆颗粒的外壳区域区域遮掩起来，然后将颗粒涂覆于非遮掩区域。
然后可以将胶粘的柔韧外壳浸入流态化(混合空气的)水性盐浴中，所述盐浴含有约10至约600微米的规则立方盐晶或约50-2000微米的圆形晶体或其组合。可通过使用制成不同尺寸或形状的盐粒(例如，圆形盐晶对有棱角的盐晶，大盐晶对较小盐晶，高密度分布的盐晶对低密度分布的盐晶)以脱盐法在所述外壳的不同区域上形成不同程度的织纹。将所述外壳旋转以均匀覆盖、取出然后稳固。在稳固一段合适的时间——例如约5-20分钟后，可将所述柔韧外壳浸渍到外涂层分散液中。可以通过使用与在基层中使用的相同材料来制造合适的外涂层分散液。然后将所述模芯上的柔韧外壳固定在搁架上并使其挥发，例如，约15分钟。
在烘箱中于高温下将整个硅氧烷弹性体外壳结构硫化或固化。烘箱的温度优选保持在约200℉至约350℉，固化时间为约20分钟至约1小时40分钟。从所述烘箱中移出后，将所述模芯/外壳组件放入所述固体颗粒的溶剂中，使所述固体颗粒溶解。所述溶剂不影响所述硅氧烷弹性体的结构或完整性。当所述固体颗粒溶解后，从所述溶剂中移出所述组件并使所述溶剂蒸发。然后可将所述外壳从所述模芯上拆下。此时，优选将所述外壳放入所述固体颗粒的溶剂中并且轻轻地搅动以确保所有固体颗粒完全溶解。当从所述溶剂中移出所述外壳时，使所述溶剂蒸发。
所述固体颗粒的溶解在所述外壳表面曾经存在盐的位置留下相互连接的洞。
根据上述步骤制成所述外壳后，制造完成的乳房植入物假体所需的步骤可以与本领域已知的步骤相似。例如，用未固化的通常由硅氧烷橡胶制成的薄片填补由所述浸渍模塑法留下来的开口。然后，若所述假体要用硅氧烷凝胶填充，就加入此凝胶并固化，将填充好的假体包装，并将包装好的假体灭菌。若所述假体要用盐水溶液填充，就装配并安装单向阀，若需要将上述假体后固化，然后将假体清洗、包装并灭菌。还可以制造组合乳房植入物假体，其中凝胶填充的囊放置在外壳内，从而被盐水溶液包围。
除上述浸渍方法外，假体植入物的柔韧外壳还可使用模塑方法形成。例如，可使用如Schuessler的美国专利No.6,602,452中所述的旋转模塑法，该专利全文纳入本文。在所述外表面形成织纹的方法可在所述外壳被模塑后使用浸渍技术来完成，但是另一个方法是使模具内侧粗糙化。例如，具有除上述的粗糙区域外基本上光滑的内表面的模具将产生具有离散固着表面的植入物外壳。旋转模塑法是有利的，因为整个植入物外壳可在较少的制造步骤中形成。
尽管本发明在一定程度上进行了具体性描述和说明，然而应理解本公开内容仅为示例，并且，在不背离下文要求保护的本发明的范围的情况下，本领域技术人员可采用部件的组合和排列的多种变化。

Claims (20)

1.一种用于植入人的假体，所述假体包括：
可植入构件，包括由前表面和后表面界定的外表面；
所述前表面和所述后表面之一包括至少一个由与所述前表面和后表面之一的剩余部分的织纹、粗糙度或光泽分别不同的织纹、粗糙度或光泽界定的大致为细长形的固着区域；
所述假体被构造为当邻近人肌群植入时，所述固着区域可与所述肌群的排列基本对齐。
2.权利要求1的假体，其中所述可植入构件包括弹性体外壳。
3.权利要求1的假体，其中所述固着区域具有第一织纹，并且所述剩余部分具有与所述第一织纹不同的第二织纹。
4.权利要求1的假体，所述假体被装配用于植入人的乳房，并且其中所述固着区域被放置并装配来在所述假体被以此方式植入人的乳房中时与胸肌群基本对齐。
5.权利要求1的假体，所述假体被装配用于放置在人的乳房中，并且其中所述固着区域被放置来在所述假体以如下方式植入人的乳房中时与胸大肌群和胸小肌群的至少一者基本对齐。
6.权利要求1的假体，其中所述至少一个固着区域包括多个固着区域。
7.权利要求1的假体，其中所述固着区域包括多个辐射状构型的固着区域。
8.权利要求1的假体，其中所述固着区域基本上完全延伸穿过所述的所述前表面和所述后表面之一。
9.权利要求1的假体，其中所述固着区域具有基本恒定的约2mm至约15mm的宽度。
10.一种乳房假体，包括：
可植入构件，包括外表面，所述外表面包含至少一个由与所述外表面剩余部分的织纹不同的织纹界定的大致为细长形的固着区域；
所述至少一个大致为细长形的固着区域被装配，从而当所述假体被植入人乳房时，所述大致为细长形的固着区域与胸大肌群和胸小肌群的至少一者的排列基本对齐。
11.权利要求10的假体，其中所述外表面由前表面和后表面界定，并且所述大致为细长形的固着区域延伸穿过所述前表面和所述后表面的至少一个。
12.权利要求10的假体，其中所述外表面由前表面和后表面界定，并且所述大致为细长形的固着区域延伸穿过所述前表面。
13.权利要求10的假体，其中所述至少一个大致为细长形的固着区域包括形成基本为辐射状构型的多个大致为细长形的区域。
14.权利要求10的假体，其中所述外表面的剩余部分是基本光滑的。
15.权利要求10的假体，其中所述外表面由前表面、后表面和所述前表面和所述后表面之间的边缘区域界定，并且所述固着区域沿着所述边缘区域延伸并穿过所述前表面和所述后表面的至少一个。
16.一种增填或修复人乳房的方法，所述方法包括：
提供可植入构件，所述可植入构件包括由前表面和后表面界定的外表面，其中所述前表面和所述后表面之一包括至少一个由与所述的所述前表面和所述后表面之一的剩余部分的织纹、粗糙度或光泽分别不同的织纹、粗糙度或光泽界定的大致为细长形的固着区域；并且
将所述可植入构件植入人乳房，从而使所述可植入构件的固着区域与胸大肌群和胸小肌群之一基本对齐。
17.权利要求16的方法，其中所述至少一个固着区域由相对于所述的所述前表面和所述后表面之一的所述剩余部分增强的织纹界定。
18.一种制造乳房假体的方法，包括以下步骤：
提供具有外表面的可填充弹性体外壳，所述外表面包括前表面和后表面；并且
仅将所述外表面的一部分织纹化以形成穿过所述前表面和所述后表面的至少一个的带状固着区域。
19.权利要求18的方法，其中所述织纹化步骤包括遮掩所述外表面的剩余部分。
20.权利要求18的方法，其中所述带状固着区域被定形并且放置以与胸大肌群和胸小肌群之一基本对齐。
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US20200297479A1 (en) 2020-09-24
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US20240041586A1 (en) 2024-02-08
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