CN110901089A - 用于制造乳房假体的方法 - Google Patents
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Abstract
本发明涉及一种用于制造乳房假体的方法,其中将第一粒状材料的第一分散体引入可交联的硅酮化合物中。随后使所述硅酮化合物固化以形成假体主体,其中将所述假体主体加热至收缩温度,该温度高于热塑性材料的熔点。
Description
本发明涉及一种用于制造乳房假体的方法和通过该方法制造的乳房假体。
乳房假体在乳房切除术后佩戴。乳房假体的要求具体包括尽可能接近天然乳房的形状和感觉以及高穿戴舒适性和良好的通气,包括与其接触的经常有疤痕的皮肤区域的热调节。
为了制造这种乳房假体,例如从WO2013/091720A1中已知制造乳房假体,其中提供了包括与乳房的前侧形状互补的腔体的铸模,将可交联的硅酮化合物倒入腔体中、使其成为层状并固化以获得乳房假体的薄皮层,使被皮层覆盖的腔体至少部分地填充有粒状可溶性材料在可交联硅酮化合物的分散体并使所述硅酮化合物固化,以及除去粒状可溶性材料以获得具有细胞结构(cellular structure)的假体主体。US 2017/367850 A1公开了针对这种的精制方法,其中将悬浮的相变材料添加到可交联硅酮化合物中,其熔点在略低于体温的范围内。
这些已知方法的缺点在于,为了从固化的硅酮基质中除去粒状可溶性材料,需要致密的球体填充,使得所有球体彼此接触,以确保冲洗通道通过整个体积。因此,假体芯的孔体积不能自由选择。孔均匀性和孔径的可调节性也不总是最佳的,并且冲洗是耗时的。难以避免可溶性物质的残留。
本发明的目的是提供一种用于制造乳房假体的通用方法,其克服了上述缺点。
在此背景下,本发明涉及一种用于制造乳房假体的方法,包括以下步骤:(b)将第一粒状材料在可交联硅酮化合物中的第一分散体引入铸模的腔体中,其中所述第一粒状材料是多孔的,优选泡沫热塑性材料;(d) 使所述硅酮化合物固化,以形成假体主体;(f)将所述假体主体加热到收缩温度,该温度高于热塑性材料的熔点。
因此,对于孔形成,根据本发明使用由热塑性材料制成的多孔塑料颗粒,其具有较之硅酮基质更低的熔点。由此多孔颗粒可以熔化,其中颗粒随着封闭在孔中的气体逸出而塌陷。获得的空腔使得基底材料显著更柔软,因为不再有背压从塑料颗粒的壁起作用。该方法不需要开孔结构和致密的球体填充。此外,硅酮基质的孔隙率和因此所需的重量减轻可以在0%至约 50%的范围内无级调节。
在一个实施方式中,提供的塑料材料是发泡聚苯乙烯、发泡聚乙烯或发泡聚丙烯。发泡聚苯乙烯(EPS)是特别优选的。
塑料材料的孔隙率可以大于0.8或大于0.9。孔隙率越大,熔化时体积的减少越强。发泡聚苯乙烯的孔隙率通常在这些范围内。
优选地,粒状材料至少在很大程度上是球形的。第一粒状材料可具有均匀的粒度分布,其中大于70%且优选大于85%的颗粒的粒径偏离平均粒径小于10%。就此而言,粒径被理解为体积当量球直径。
在一个实施方式中,提供的塑料材料的熔点为120-180℃。相应地,收缩温度可在约140-200℃之间。
在一个实施方式中,提供的所述方法还包括在步骤(b)之前的以下步骤:(a)制造乳房假体的皮层,其中将可交联的硅酮化合物倒入腔体中、使其成为层状并固化。皮层的层厚例如可以是2-6mm,优选3-5mm。然后将第一分散体引入到由皮层覆盖的腔体中。皮层优选完全不包含分散的颗粒,或者至少不包含由泡沫热塑性材料制成的分散颗粒。
在一个实施方式中,提供的所述方法还包括在步骤(b)和(d)之间进行的以下步骤:(c)制造假体主体的无孔末端区。
优选地,提供了将对模(countermold)置于在腔体中存在的第一分散体上以固定该第一分散体的形状,随后支撑铸模并且在铸模倒置的情况下使硅酮化合物固化。通过将模具倒置,具有比硅酮化合物更低密度的第一粒状材料上升到现在位于顶部的铸模的前侧,使得在现在位于底部的第一分散体的后端区域中,形成末端区,该区包含第一分散体的硅酮化合物而没有分散的第一粒状材料。
或者,无孔末端区可以通过如下来实现:例如将较高粘度的硅酮化合物施加到待固化的假体主体的背面上或将低粘度硅酮化合物填充到待固化的假体主体与对模之间的间隙中。
在一个实施方式中,提供的所述方法还包括在步骤(d)和(f)之间进行的以下步骤:(e)制造乳房假体的接触层,其中将第二粒状材料在可交联的硅酮化合物中的第二分散体引入已经包含假体主体的腔体中,使得假体主体的背部被至少部分地覆盖,随后固化第二分散体的硅酮化合物。因此,可以制造背侧接触层。通过适当的程序,可以实现确定的开孔率。例如,接触层可以设计成具有面向载体的开口,其中铸模倒置使得球体上升到表面,或者球体填充可以如此致密以致颗粒突破到表面。结果,形成通气表面结构,其产生优化的微气候。背侧层应选择得足够厚,以便获得良好的通气,但是被选择得足够薄,以便在清洁后它可以很好地干燥。
由于假体主体的无孔末端区,杂质不能穿透到假体主体中。
第二粒状材料同样可以是泡沫热塑性材料,其熔点低于收缩温度。在一个实施方式中,规定第一分散体的第一粒状材料和第二分散体的第二粒状材料由相同的塑料材料组成。这有利于程序,因为在这种情况下,两种塑料材料的最佳收缩温度是相同的。可以规定,第一和第二颗粒的材料通常是相同的,即也具有相同的孔隙率等。
或者,第二粒状材料还可包含可溶性材料,例如糖。在是糖(例如焦糖化)的情况下,优选在步骤(f)中加热之前洗掉该材料以防止化学变化。
在一个实施方式中,提供的第二粒状材料的平均粒径大于第一粒状材料的平均粒径。可以提供瞄准接触层的较大孔,因为这可以导致更柔软的质量和更好的通气。
步骤(a)、(b)和(e)中使用的硅酮化合物可以在化学上彼此对应。用于每个步骤的合适的硅酮化合物包括加成交联的双组分硅橡胶化合物。通过交联进行的固化通常可以在室温下或在更高的温度下进行。
向用于形成无孔末端区的硅酮化合物,或者在步骤(e)存在的情况下,向第二分散体的硅酮化合物,可以加入相变材料,其相变温度接近于体温。合适的实例包括具有合适数量的碳原子的石蜡,通常为约20,以将熔点调节在所需范围内。通过将相变材料特别地添加到用于形成无孔末端区的硅酮化合物或第二分散体的硅酮化合物中,由此产生靠近身体的层,相变材料在需要其作用的地方起作用,即直接在穿着者的身体起作用。
本发明还涉及具有多孔假体主体的乳房假体,其中假体主体通过根据本发明的方法制造。由于制造类型,假体主体在其孔中包含熔融热塑性材料的残余物。然而,这些残留物对假体的触觉性质没有任何可察觉到的影响。
假体的优选实施方式可以从与本发明的方法有关所描述的方面中获得。特别地,当该方法包括前述步骤(a)时,假体可包括与假体主体的前侧毗邻的层,优选为皮层。此外,当该方法包括中间步骤(c)时,假体可包括假体主体的无孔背侧末端区。此外,当该方法包括中间步骤(e)时,假体可在假体主体的背面上包括多孔接触层。当假体包括所有这些层时是特别优选的。
本发明的进一步细节和优点可以从下面参考附图描述的示例性实施方式中获得。
附图说明:
图1:示出了根据本发明的乳房假体的一个实施方式;
图2:示出了根据本发明的乳房假体的另一个实施方式;
图3:示出了用于制造根据本发明的乳房假体的铸模,其中乳头仿制品被插入腔体中;
图4:示出了图3的铸模,其具有覆盖腔体的皮层;
图5:示出了图4的铸模,其中注入了第一分散体;和
图6:示出了图5的铸模,其中注入了第二分散体。
图1-2示出了根据本发明的乳房假体的两个不同实施方式。两个假体都包括多孔假体主体10,其在其前侧具有无孔的皮层20并且在其背面上具有无孔的末端区11。在皮层20的前侧上还安装有乳头仿制品21。层10和20以及优选地还有乳头仿制品21由硅橡胶制成。
图2中所示的乳房假体另外包括多孔接触层30,其毗邻假体主体10的后部。所有层10、20和30以及优选地还有乳头仿制品21由硅橡胶制成,其中层10和30具有不同的孔隙率和不同的孔结构。多孔接触层30的孔32大于假体主体10的孔12。此外,多孔接触层30的孔结构是开孔的,具有接近于最致密球体填充的空间填充度的高孔隙率,而假体主体10具有孔隙率较低的闭孔结构。
由于假体主体10的无孔末端区11,杂质不能从接触层30前进到假体主体10中。
参考图3-6,可以解释用于制造根据本发明所图示的假体的方法。
图3中所示的铸模1包括腔体2,腔体2的形状与女性乳房相对应。铸模 1通常由耐高温材料制成。腔体2的形状可以是定制的或适合于批量生产。乳头仿制品21在相应的点处插入腔体2中。仿制品21可由特别着色的硅橡胶制成。柔软度同样可以偏离剩余的硅酮。例如,有用的硅酮是Wacker- Chemie公司的可以通过将可固化的硅酮化合物引入腔体2 中并使其固化来制造乳头仿制品11。相应的区域可以通过临时插入腔体2 中的塑料环来界定。交联可以在室温下或在更高的温度下进行。
接下来,制造皮层20,如图4所示。为此目的,将可交联的硅酮化合物填充到开口腔体2中,随后用未示出的对应物封闭,以便通过随后的交联生产具有2-3mm的厚度的皮层20。或者,可以将硅酮化合物压入已经用对应物封闭的腔体2中。交联反过来可以在室温下或在更高的温度下进行。
随后,如图5所示,将包含平均粒径为1-2mm的发泡聚苯乙烯(EPS) 球体的第一分散体填充到开口腔体2中,所述球体被分散在可交联的硅酮化合物中。然后用未示出的对应物封闭腔体2,并且硅酮化合物是交联的。
富集的硅酮化合物涂覆有另一个厚度约1-2mm的薄硅酮层,以形成无孔的末端区11。这可以通过如下来实现:例如在待固化的假体主体的背面施加更高粘度的硅酮化合物或将低粘度的硅酮化合物填充到待固化的假体主体和对应物之间的间隙中。
在图2的变型中,施加另一层,如图6中可见。该层导致多孔接触层30 毗邻假体主体10的背面。即,包含平均粒径大于2mm的发泡聚苯乙烯 (EPS)球体(该球体分散在可交联的硅酮化合物中)的第二分散体填充到开口腔体2中并交联。
向第二分散体,另外加入平均碳数为约20的石蜡,其相变温度接近体温。通过将相变材料特别地添加到产生多孔接触层30的第二分散体中,相变材料在需要其作用的地方起作用,即直接在穿用者的身体处起作用。
如果不是系列工具,背面的模制部件可以被调整成女性顾客的疤痕轮廓。
最后,移除背面的模制部件。塑料球的收缩在约150-180℃下进行约2 小时。将模具1与假体一起加热或首先将硅酮假体从模具中取出。已证明其在模具1中的加热是有价值的,因为省略了从模具中难以移除的紧凑假体。
由于硅酮表面可能略微发粘,这会使插入胸罩口袋变得更加困难,因此硅酮表面也用NuSil公司的低摩擦硅酮涂层MED10-6670进行处理。
Claims (11)
1.一种用于制造乳房假体的方法,包括以下步骤:
(b)将第一粒状材料在可交联硅酮化合物中的第一分散体引入铸模的腔体中,其中所述第一粒状材料是多孔的并且优选地为泡沫热塑性材料;
(d)将所述硅酮化合物固化以形成假体主体;和
(f)将所述假体主体加热到收缩温度,该温度高于所述热塑性材料的熔点。
2.根据权利要求1所述的方法,其特征在于,所述塑性材料是发泡聚苯乙烯、发泡聚乙烯或发泡聚丙烯。
3.根据前述权利要求中任一项所述的方法,其特征在于,所述塑性材料的熔点为120-180℃,并且所述收缩温度在140-200℃之间。
4.根据前述权利要求中任一项所述的方法,其特征在于,所述方法还包括在步骤(b)之前的以下步骤:
(a)制造所述乳房假体的皮层,其中将可交联的硅酮化合物倒入腔体中、形成层状并固化。
5.根据前述权利要求中任一项所述的方法,其特征在于,所述方法还包括在步骤(b)和(d)之间进行的以下步骤:
(c)制造所述假体主体的无孔末端区。
6.根据前述权利要求中任一项所述的方法,其特征在于,所述方法还包括在步骤(d)和(f)之间进行的以下步骤:
(e)制造所述乳房假体的接触层,其中将第二粒状材料在可交联硅酮化合物中的第二分散体引入已经包含所述假体主体的腔体中,使得所述假体主体的背部至少被部分覆盖,随后使所述第二分散体的硅酮化合物固化。
7.根据权利要求6所述的方法,其特征在于,所述第二粒状材料也是泡沫热塑性材料,其熔点低于所述收缩温度。
8.根据权利要求6-7中任一项的方法,其特征在于,所述第二粒状材料的平均粒径大于所述第一粒状材料的平均粒径。
9.根据权利要求5-8中任一项的方法,其特征在于,将相变材料引入所述无孔末端区和/或所述接触层。
10.一种具有多孔假体主体的乳房假体,其中所述假体通过根据前述权利要求中任一项所述的方法制造。
11.根据权利要求10所述的乳房假体,其特征在于,所述乳房假体包括与所述假体主体的前侧毗邻的无孔皮层,和/或所述假体主体包括无孔的背侧末端区,和/或所述乳房假体包括与所述假体主体背部毗邻的多孔接触层。
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JP2004083876A (ja) * | 2002-07-02 | 2004-03-18 | Watanabe Kk | シリコーンゴム多孔質成形体 |
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WO2013091720A1 (en) * | 2011-12-22 | 2013-06-27 | Trulife Limited | A breast prosthesis and method for manufacturing the same |
DE102016003448A1 (de) * | 2016-03-21 | 2017-09-21 | Amoena Medizin-Orthopädie-Technik GmbH | Brustprothese mit Verschlusspfropfen für Einfüllkanal |
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JP2004083876A (ja) * | 2002-07-02 | 2004-03-18 | Watanabe Kk | シリコーンゴム多孔質成形体 |
US20100256777A1 (en) * | 2009-04-03 | 2010-10-07 | Biometrix Corporation | At least partially resorbable reticulated elastomeric matrix elements and methods of making same |
US20120077010A1 (en) * | 2010-09-28 | 2012-03-29 | Allergan, Inc. | Porous materials, methods of making and uses |
CN105034395A (zh) * | 2014-04-30 | 2015-11-11 | 爱蒙娜医药整形技术有限责任公司 | 乳房假体的制造方法 |
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US20170367850A1 (en) * | 2016-06-23 | 2017-12-28 | American Breast Care, Lp | Breast Prostheses with Phase Change Material |
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US11491031B2 (en) | 2022-11-08 |
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