CN110384829A - 使用化学方式制备的泡沫填充物来降低乳房植入物重量 - Google Patents
使用化学方式制备的泡沫填充物来降低乳房植入物重量 Download PDFInfo
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Abstract
本发明题为“使用化学方式制备的泡沫填充物来降低乳房植入物重量”。本发明提供了一种用于制造乳房植入物的方法，该方法包括通过将碳酸盐与水解有机硅混合来制备包含泡沫的弹性填充材料。向柔性外壳填充所述弹性填充材料，所述柔性外壳被构造用于在人类受试者的乳房内植入。
Description
技术领域
本发明整体涉及医疗植入物，并且具体地讲，涉及乳房植入物。
背景技术
乳房植入物被插入人类乳房中或附接在乳房上，例如，以便替换在诸如乳房切除术的手术中或出于美容用途已被医学移除的组织。乳房植入物的用途是恢复乳房的外部形式，包括其触感和重量。
专利文献中提出了各种技术来形成乳房植入物。例如，美国专利5,658,330描述了用于在皮肤之下植入的乳房假体。在一个实施方案中，该假体具有外部弹性外壳，该外部弹性外壳包封生物相容性流体和一体式构造的有机硅泡沫插入件，该有机硅泡沫插入件具有乳房组织的形状和近似的一致性。泡沫插入件基本上占据由可植入假体的外壳包封的整个体积，并且由模制成乳房形状的泡沫体组成。插入件为一体式构造并且通过以下步骤制成：(a)将模具加热至适当的温度；(b)将气泡混合进未固化有机硅的分散体；(c)将带气泡的未固化有机硅注入预热模具；以及(d)施加真空，直至泡沫插入件固化。
又如，美国专利9,339,371描述了用于假体植入物的假体植入物材料，其包含凝胶并任选地包含气体。在一个实施方案中，填充材料为无限制等级的有机硅凝胶和填充有气体的专门定制的中空玻璃微球的混合物。
美国专利申请公布2011/0029077描述了一种医疗植入物，该医疗植入物包括具有不同尺寸气泡的多孔硅，以及包封多孔硅的硅膜。另外，该医疗植入物包括具有气泡的多孔硅球和包封该多孔硅球的硅膜。可适当调节衬垫和植入物的重量以便将衬垫维持在和人体细胞的水平相似的水平，并缩短恢复时间。将多个沟槽或通孔设置在植入物表面上，从而体液顺畅地流动通过沟槽或通孔以改善植入物对细胞的亲和力。
发明内容
一种用于制造乳房植入物的方法，该方法包括通过将碳酸盐与水解硅混合来制备包含泡沫的弹性填充材料。向柔性外壳填充所述弹性填充材料，所述柔性外壳被构造用于在人类受试者的乳房内植入。
在一些实施方案中，该方法还包括在混合水解有机硅和碳酸盐期间或之后，通过旋转泡沫来使泡沫均匀化。
在一些实施方案中，混合碳酸盐包括混合碳酸氢钠。
在一个实施方案中，将碳酸盐与水解有机硅混合包括将所述水解有机硅与所述碳酸盐与所述催化剂混合。在另一个实施方案中，制备弹性填充材料包括制备与二氧化碳气泡混合的有机硅凝胶泡沫。
在一些实施方案中，制备弹性填充材料包括通过精调二氧化碳气泡的尺寸和密度中的至少一者来精调有机硅凝胶的硬度。
根据本发明的实施方案另外提供了一种乳房植入物，该乳房植入物包括弹性填充材料和柔性外壳。弹性填充材料包含与二氧化碳气泡混合的有机硅凝胶的均匀泡沫。柔性外壳包含弹性填充材料并且被构造用于在人类受试者的乳房内植入。
结合附图，通过以下对本发明的实施方案的详细描述，将更全面地理解本发明，其中：
附图说明
图1为根据本发明的实施方案的具有乳房植入物的人类女性乳房的示意性截面图；以及
图2是示意性地示出了根据本发明的实施方案的用于为乳房植入物制备泡沫填充物的方法的流程图。
具体实施方式
概述
乳房植入物可包含弹性填充材料，诸如包含在密封柔性外壳中的有机硅凝胶。填充有此类材料的乳房植入物会相对较重，并且可能使植入物的佩戴者感到不适。为了减少植入物的重量，可将气体诸如空气或二氧化碳注入凝胶中，以有效地形成泡沫和/或乳液。然而，气体注入可能相对复杂，并且更简单的过程将是有用的。
下文描述的本发明的实施方案提供用作乳房植入物的可植入装置。在一些实施方案中，通过化学反应制备植入物的泡沫填充物。在下文的描述中，为了简洁起见，泡沫和/或乳液统称为“泡沫”。为了制备泡沫，所公开方法的一个实施方案使用如下事实：有机硅凝胶通过有机硅单体的水解形成，产生盐酸(HCl)作为副产物。将碳酸盐诸如碳酸氢钠加入水解的混合物中，并且碳酸盐与HCl反应以产生二氧化碳气泡(和常见的盐，NaCl)。可将具有气泡的混合物旋转，使凝胶中的气泡均匀化。
在一个实施方案中，在制备期间通过调整所制造的硅凝胶的硬度来调整植入物弹性，使得用最软的有机硅凝胶制成的植入物的重量将为使用最软有机硅凝胶制成的植入物的约70％。在一个实施方案中，精调有机硅凝胶的硬度通过精调整在凝胶中产生的气泡的尺寸和/或密度来执行。凝胶的硬度可在凝胶制备过程的发育阶段确定，例如通过试误法，并且通过稳定的制造过程保持不变。
在一些实施方案中，提供了一种植入物，通过使用化学过程以产生气泡，该植入物包含高度均匀的有机硅凝胶。
所公开的技术可例如通过消除制造步骤诸如气体注入和密封步骤来简化轻型乳房植入物的形成。此外，所公开的技术可例如通过避免另外的过程诸如冲洗掉HCl副产物来简化有机硅凝胶自身的制造过程。因此，实施所公开的技术可提高轻型乳房植入物的可用性。
系统说明
图1为根据本发明的实施方案的具有乳房植入物21的人类女性乳房20的示意性截面图。植入物21包括填充有轻质泡沫23的外壳22，而泡沫23的制备在下文有更详细的描述。在所公开的实施方案中，乳房植入物21作为乳腺植入物定位在乳房组织24和胸大肌26之间。本领域的技术人员应当理解，在另选的实施方案中，参考植入物相对于胸大肌26的不同位置，乳房植入物21可被定位成筋膜下、胸肌下、或肌下植入物。图1所示的示例是完全为了概念清楚而选择的。本发明的实施方案可应用于包含泡沫的乳房植入物的任何设计。
使用化学方式制备的泡沫填充物来降低乳房植入物重量
图2为根据本发明的实施例的示意性地示出用于制备泡沫填充物23的方法的流程图。在有机硅凝胶的部分制备阶段期间，水解有机硅包含盐酸(HCl)。在一些实施方案中，在制备步骤30处提供了以HCl作为副产物的水解有机硅混合物。在制备步骤中的一个步骤期间，在碳酸盐添加步骤32中，将碳酸盐诸如碳酸氢钠(NaHCO3)加入水解的混合物中，并且碳酸盐与HCl反应以产生二氧化碳气泡(和常见的盐，NaCl)：
NaHCO3+HCl→NaCl+H2O+CO2(g)
在一些实施方案中，可以将催化剂加入混合物中以加快步骤32的气泡的制备，以及/或者加快所得有机硅凝胶固化的速度。
最后，在混合物均化步骤34处，将泡沫置于旋转器上，该旋转器旋转混合物以使泡沫中的二氧化碳气泡的空间分布均匀(即均化)。
在一些实施方案中，使用图2的方法制备填充有填充材料的柔性外壳，然后密封外壳以产生乳房植入物21。
图2所示的示例性流程图完全是为了概念清晰而选择的。化学反应产生气泡时的化学物质量和/或条件可以变化，以便精调凝胶中通过化学方式得到的气泡的尺寸和/或密度，以及气泡尺寸的变化。
如上所述，可将其它化学物质用于产生泡沫，其中以举例的方式提出了碳酸氢钠。可包括其它制造步骤，诸如过滤和温度设置，为清楚起见，这些步骤未示出。制造步骤的时间安排可以有所不同。例如，混合物的旋转可在制备步骤32期间、之前或之后开始。
虽然本文描述的实施方案主要涉及乳房植入物，但是本文所述的方法和系统也可用于需要包含有机硅凝胶的植入物为轻质的其它应用中。
因此应当理解，上面描述的实施方案以举例的方式被引用，并且本发明不限于上文特定示出和描述的内容。相反，本发明的范围包括上文描述的各种特征的组合和子组合以及它们的变型和修改，本领域的技术人员在阅读上述描述时将会想到所述变型和修改，并且所述变型和修改并未在现有技术中公开。以引用方式并入本专利申请的文献被视为本申请的整体部分，不同的是如果这些并入的文献中限定的任何术语与本说明书中明确或隐含地给出的定义相冲突，则应仅考虑本说明书中的定义。
Claims (7)
1.一种用于制造乳房植入物的方法，所述方法包括：
通过将碳酸盐与水解有机硅混合来制备包含泡沫的弹性填充材料；以及
向柔性外壳填充所述弹性填充材料，所述柔性外壳被构造用于在人类受试者的乳房内植入。
2.根据权利要求1所述的方法，并且包括通过在混合所述水解有机硅和所述碳酸盐期间或之后，通过旋转所述泡沫来使所述泡沫均匀化。
3.根据权利要求1所述的方法，其中混合所述碳酸盐包括混合碳酸氢钠。
4.根据权利要求1所述的方法，其中将所述碳酸盐与所述水解有机硅混合包括将所述水解有机硅与所述碳酸盐与所述催化剂相混合。
5.根据权利要求1所述的方法，其中制备所述弹性填充材料包括制备与二氧化碳气泡混合的有机硅凝胶泡沫。
6.根据权利要求5所述的方法，其中制备所述弹性填充材料包括通过调整所述二氧化碳气泡的尺寸和密度中的至少一者来调整所述有机硅凝胶的硬度。
7.一种乳房植入物，所述乳房植入物包括：
弹性填充材料，所述弹性填充材料包含与二氧化碳气泡混合的有机硅凝胶的均匀泡沫；和
柔性外壳，所述柔性外壳包含所述弹性填充材料并且被构造用于在人类受试者的乳房内植入。
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| US11324585B2 (en) | 2018-10-12 | 2022-05-10 | Biosense Webster (Israel) Ltd. | Method for producing shell and foam filler for a breast implant |
| US11123903B2 (en) | 2018-10-25 | 2021-09-21 | Biosense Webster (Israel) Ltd. | Controlling bubble formation in silicone foam filler of breast implants |
| CN119789957A (zh) | 2022-07-28 | 2025-04-08 | 埃肯有机硅美国公司 | 有机硅泡沫组合物 |
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