CN110312493B - 使用感应加热的热可膨胀乳房植入物 - Google Patents

使用感应加热的热可膨胀乳房植入物 Download PDF

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CN110312493B
CN110312493B CN201880013055.2A CN201880013055A CN110312493B CN 110312493 B CN110312493 B CN 110312493B CN 201880013055 A CN201880013055 A CN 201880013055A CN 110312493 B CN110312493 B CN 110312493B
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expandable
implant
breast implant
closed conductive
expandable material
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CN110312493A (zh
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V.格林纳
D.戴维
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Biosense Webster Israel Ltd
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Biosense Webster Israel Ltd
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Abstract

本文提供一种能够选择性膨胀的乳房植入物(100)以及用于组织扩张的方法。该植入物包括柔性外壳(110)、位于该柔性外壳内部的可膨胀材料(150)以及位于该可膨胀材料内的多个闭合导电环(130)。这些闭合导电环从该植入物外部的变化的磁场吸收能量并生成热量，以对周围的可膨胀材料进行加热，并且该可膨胀材料基于由这些闭合导电环生成的热量的量来在尺寸上扩张。该可膨胀材料包括响应于由这些闭合导电环生成的热量而膨胀的多个可膨胀微球体。热感应机构使这些闭合导电环能够生成热量，以用于使该植入物中的该可膨胀材料膨胀。该植入物可均匀地膨胀或者在指定用于选择性成形的区域中膨胀。

Description

使用感应加热的热可膨胀乳房植入物
发明内容
组织扩张器是被植入患者的皮肤之下并且然后逐渐充胀以拉伸叠置的组织的装置。此类扩张器用于在皮肤之下形成接收永久性假体的扩大区域，或者用于生成增加的皮肤表面积，使得皮肤可用于移植或重建。
组织扩张器通常与可植入装置结合使用，因为扩张器是临时性装置，其最终由更永久性植入物取代。利用该方法，需要两个大外科手术：用于插入扩张器的第一手术和用于移除扩张器并插入更永久性植入物的第二手术。就乳腺植入物而言，组织扩张器和植入物用于寻求美学乳房扩增的患者和乳房切除术后需要重建的乳腺癌患者。用于分阶段乳房扩增或重建的当前技术涉及用于初始地插入扩张器的第一大手术、用于将盐水或另一流体注入到扩张器中的多个后续“小”手术、然后是用于移除扩张器并插入更永久性植入物的最终手术。
此外，由于疼痛和潜在感染、炎症和肿胀，用流体填充扩张器的多个小手术是焦虑和不适的根源。因此，将有利的是，消除对当前用于分阶段乳房扩增和重建的多个外科手术的需要。
根据所描述实施方案，提供一种医疗装置，其包括能够选择性膨胀的永久性植入物，该永久性植入物包括柔性外壳、位于该柔性外壳内部的可膨胀材料、以及位于该可膨胀材料内的多个闭合导电环。该多个闭合导电环吸收来自该柔性外壳外部的能量源的能量，并且生成热量以对该可膨胀材料进行加热。紧密靠近这些闭合导电环定位的可膨胀材料变热，从而基于由这些闭合导电环生成的热量的量来在尺寸上扩张。在一个方面，该可膨胀材料包括多个可膨胀微球体，其中每个微球体包括包封可膨胀气体的聚合物外壳。在另一方面，每个闭合导电环包括圆形的导电金属材料。
本文还提供一种利用植入物进行组织扩张的方法，该植入物具有容纳可膨胀材料和多个导电环的柔性外壳，该方法包括将该植入物暴露于该植入物外部的能量源，从而致使该多个导电环变热；基于由该多个导电环产生的热量来使该可膨胀材料膨胀；以及在已实现可膨胀材料的期望膨胀的条件下移除该能量源。
通过要结合附图阅读的对本发明说明性实施方案的以下详细说明，本发明的这些目标和其他目标、特征和优点将显而易见。
附图说明
图1是根据本发明的实施方案的剖视图。
图2是本发明的可膨胀材料的图示，其示出可膨胀材料在暴露于热量时如何膨胀。
图3是本发明的闭合导电环在由于其暴露于变化磁场而生成热量时的示例性图示。
图4是与一个或多个所公开的实施方案接合使用的示例性变化磁场生成系统的框图。
图5是如何将实施方案放置在变化磁场内部的示例性图示。
图6是与所公开的实施方案结合使用的示例性程序的流程图。
图7是根据本发明的一个实施方案的剖视图，其示出闭合导电环的均匀分布。
图8是根据本发明的另一实施方案的剖视图，其示出闭合导电环的均匀分布，其中植入物具有周边缓冲区域，该周边缓冲区域没有闭合导电环。
图9是根据本发明的另一实施方案的剖视图，其示出具有在指定用于植入物的成形的预先确定的区域中紧密地聚集在一起的闭合导电环的植入物。
图10是根据本发明的另一实施方案的剖视图，其示出具有带有低分布的闭合导电环的区域和具有高分布的闭合导电环的区域的植入物。
具体实施方式
在以下段落中描述了本发明的各种实施方案。在多个实施方案中描绘了类似的元件的情况下，为了便于理解，使用了相同或类似的附图标号。
参考图1，所示出的是可膨胀植入物100，该可膨胀植入物100消除了与现有手术(包括用于注射具有流体的扩张器的多个“小”外科手术和用于移除扩张器并放置植入物的“大”外科手术)相关联的大多数缺点。因此，本发明改进分阶段乳房扩增和重建过程，并且降低由于感染、炎症和疼痛引起的并发症的可能性。
再次参考图1，示出能够选择性膨胀的永久性植入物100，其具有封装可膨胀材料150和由导电材料制成的多个闭合导电环130的柔性硅外壳110。在一个实施方案中，其可作为示例在下文中涉及，植入物100是永久性乳房植入物。另外，虽然植入物100在下文中被称为永久性的，但它也可用作非永久性扩张器。
在一个实施方案中，硅外壳110包括柔性生物相容性聚合物。外壳110必须是柔性的，以便模仿人类乳房的自然外观和感觉。外壳110也必须是牢固的，以便吸收对身体的物理冲击而不渗漏或断裂。
可膨胀材料150包括在被加热到特定温度时膨胀的材料；(例如，当施加热源时)。在一个实施方案中，可膨胀材料150至少部分地包括多个微球体。现在参考图2，其示出根据一个实施方案的微球体200。每个微球体200包括聚合物外壳230，该聚合物外壳230用具有外表面225的空核220包封可膨胀气体。在一个实施方案中，可膨胀气体是氢气H2。当将热量施加到微球体200时，可膨胀气体变热，这致使可膨胀气体膨胀。这继而致使聚合物外壳230膨胀。聚合物外壳230以围绕聚合物外壳230的可变宽度290为特征。聚合物外壳230在膨胀之前的可变宽度290大于聚合物外壳230在膨胀之后的宽度295。当微球体200被加热时，来自可膨胀气体的内部压力增大并且聚合物外壳230软化，从而导致微球体200的体积大幅增加。气体保持在微球体200内部。膨胀的量可由在特定时间段内施加到微球体200的热量的量控制。在一个实施方案中，微球体200包括得自Boud Minerals公司的ExpancelMicrospheres，其中微球体200在膨胀之前的直径280介于2微米和20微米之间，并且微球体200在膨胀之后的直径285介于12微米和100微米之间。微球体200基于施加到它们的热量的量来在尺寸上扩张。在图1所示的实施方案中，微球体200包括整个可膨胀材料150。
一旦不再施加热量，微球体200就永久性地保持它们膨胀的尺寸。这种膨胀在图2中以图形方式示出，其中左侧是膨胀之前的微球体200，而右侧是膨胀之后的微球体200。
参考图3，每个闭合导电环130包括单个导电金属环。虽然在下文中被示出为单个环，但闭合导电环130可具有替代形状—允许电流流动的任何形状。多个闭合导电环130在可膨胀材料150内混合。优选地，闭合导电环130在可膨胀材料150中均匀地混和，使得在整个植入物100中存在均匀分布的闭合导电环130和可膨胀材料150。闭合导电环130优选地处于足够高的浓度，并且分布在整个可膨胀材料150中，使得由闭合导电环130生成的热量足以使周围的可膨胀材料150膨胀。
由闭合导电环130生成的热量的量取决于穿过闭合导电环130的磁通量的改变水平。其中放置有闭合导电环130的变化磁场(未示出)可产生快速改变的磁场，从而形成穿过闭合导电环130的磁通量的改变。变化磁场改变越大，闭合导电环130产生的热量将越多。此外，闭合导电环130的直径可以是小的—例如，至多1毫米。即使在如此小的直径的情况下，闭合导电环130仍将产生足够的热量以使邻近的可膨胀材料150膨胀。在一个实施方案中，闭合导电环130全部为大致相同尺寸，使得每个闭合导电环130产生相同量的热量。然而，在替代实施方案中，可利用不同的尺寸。
参考图3，更详细地示出了闭合导电环130。闭合导电环130包括具有高电导率的材料，诸如铜、金或铝。图3所示的闭合导电环130为简单说明起见被示出为在固体的材料302中。然而，本领域技术人员将认识到，材料302可包括如图2所示的多个微球体200。当闭合导电环130被放置在变化磁场(未示出)中时，在闭合导电环130内生成电流。由于闭合导电环130是部分电阻性的，因此当在它们在诱发电流时它们变热。所生成的热量被传递到周围的材料302，该材料302开始升高温度。这在图3中以图形方式示出为受热的材料304。由于闭合导电环130被放置在变化磁场(未示出)中，因此生成电流，闭合导电环130变热，并且将所生成热量传递到周围的材料304。
参考图4，框图示出在其中可实现一个或多个所公开实施方案的示例性变化磁场生成系统400。变化磁场生成系统400包括处理器402、存储器404、图形用户界面(“GUI”)装置406、一个或多个输入装置408以及场生成器410。应当理解的是，变化磁场生成系统400可包括图4中未示出的另外的部件。
处理器402可包括中央处理单元(CPU)。存储器404可与处理器402位于同一晶粒上，或者可与处理器402分开定位。存储器404可包括易失性或非易失性存储器，例如，随机存取存储器(RAM)、动态RAM或高速缓存。
GUI装置406使用视觉输出进行显示。GUI装置406还可包括触敏屏幕。输入装置408可包括键盘、小键盘、触摸屏、触摸板、检测器、麦克风、加速计、陀螺仪、生物识别扫描器或网络连接器(例如，用于传输和/或接收无线IEEE 802信号的无线局域网卡)。输入装置408可与处理器402通信，并且处理器402接收来自输入装置408的输入。场生成器410发射变化磁场，该磁场的功率由医师控制。这允许医师确定要施加到闭合导电环130的功率量，以及最终实现微球体200和植入物100的期望膨胀的时间。
参考图5，示出了变化磁场生成系统400。变化磁场生成系统400发射局部变化磁场510，该局部变化磁场迅速改变—例如多达10Khz及以上，以便在闭合导电环130中产生显著磁通量改变。变化磁场生成系统400被被配置成能够舒适地容纳具有一个或多个乳房植入物530的患者520。所生成的变化磁场510通过植入物530。这在多个闭合导电环130内生成电流。此外，由于1/r^3描述远场磁强度的减小，因此变化磁场510的功率相对于植入物530与变化磁场510的接近度而直接增大和减小。随着植入物530远离变化磁场510移动，植入物530的闭合导电环130内所产生的电流减小。
如前所述，闭合导电环130变热，并且将热量传递到周围的可膨胀材料150。通过利用变化磁场510，如图5所示，植入物530使用非接触式加热方法，这是有利的，因为现有技术方法在插入用于膨胀手术的针期间可能引起感染和疼痛和焦虑。
参考图6，流程图示出通过利用变化磁场生成系统400来使植入物100膨胀的过程600。如图6所示，过程600以确认已被选择用于膨胀的区域开始610。然后确定620植入物100暴露于变化磁场510的持续时间。变化磁场生成系统400将形成变化磁场510(步骤630)。在植入物100已暴露于变化磁场510达特定时间量之后，将确定暴露时间是否已过去(步骤640)。如果植入物100已完成所分配暴露时间的完整持续时间，则变化磁场生成系统400将禁用场(步骤650)。如果植入物100仍需要另外的暴露时间，则变化磁场生成系统400将再次形成场(步骤630)，直到已完成完整期望暴露时间为止。在完成完整暴露时间时且在已关闭场(步骤650)之后，将检查植入物100以确定膨胀量(步骤660)。将决定是否已实现足够的膨胀(步骤670)。如果已实现足够的膨胀，则过程完成(步骤680)。如果需要进一步膨胀，则将确定所需的另外的暴露时间的量，以便可实现足够的膨胀(步骤620)。
参考图7，示出该第一实施方案的透视图，其中闭合导电环130均匀地分布在可膨胀材料150内以使植入物100均匀地膨胀。
图8、图9和图10是植入物100的另选的实施方案的图示。参考图8，示出了第一另选的实施方案。在该实施方案中，可膨胀植入物100具有不含闭合导电环130的周边区域830。这作为周边区域830的圆周周围的缓冲区域850保护周围组织免受植入物100内的闭合导电环130的升高的温度。
参考图9，示出另一个另选的实施方案，其中植入物100在可膨胀材料150内具有不均匀分布的闭合导电环130。虽然不均匀分布被示出为朝向植入物的底部，但可将分布选择成实现期望的任何类型的成形或赋形。在所示特定示例中，植入物100具有在可膨胀材料150内指定用于成形以对组织的目标区域赋形的选定区域950中紧密聚集在一起的闭合传导环130。值得注意的是，被靶向成形的这些选定区域950可位于植入物100的下半部中，如图9所示。植入物100的膨胀模式的这种可选择性允许医师出于不同的原因定制植入物的膨胀。例如，植入物100的选择性膨胀可提供对松垂组织的补救。此外，该实施方案在可膨胀材料150内具有并非指定用于植入物100的任何成形或膨胀的预先确定的区域970。在该预先确定的区域970中，不存在闭合导电环130。
参考图10，示出另一另选的实施方案，其中植入物100在可膨胀材料150内具有不均匀分布的闭合导电环130。特别地，植入物100具有带有低分布1060的闭合导电环130的区域和带有高分布1080的闭合导电环130的区域。在具有低分布1060的闭合导电环130的区域中，将发生较小的膨胀和成形。在具有高分布1080的闭合导电环130的区域中，将发生较大的膨胀和成形。值得注意的是，具有高分布1080的闭合导电环130的区域可位于植入物100的下半部中(如图10所示)，以提供例如对松垂组织的补救。
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Claims (9)

1.一种能够选择性膨胀的乳房植入物，包括：
柔性外壳；
可膨胀材料，所述可膨胀材料在所述柔性外壳内部；和
多个导电环，所述多个导电环在所述可膨胀材料内；
其中所述多个导电环从所述柔性外壳外部的能量源吸收能量并生成热量以对所述可膨胀材料进行加热；
其中所述可膨胀材料基于由所述多个导电环生成的热量的量来在尺寸上扩张；并且
其中所述可膨胀材料包括多个可膨胀微球体。
2.根据权利要求1所述的能够选择性膨胀的乳房植入物，其中所述多个可膨胀微球体中的每个可膨胀微球体包括包封气体的聚合物外壳。
3.根据权利要求1所述的能够选择性膨胀的乳房植入物，其中所述多个导电环中的每个导电环包括圆形金属元件。
4.根据权利要求3所述的能够选择性膨胀的乳房植入物，其中所述圆形金属元件包括导电金属材料。
5.根据权利要求1所述的能够选择性膨胀的乳房植入物，还包括设置在所述柔性外壳和所述多个导电环之间的缓冲区域，其中所述缓冲区域不包括任何导电环。
6.根据权利要求1所述的能够选择性膨胀的乳房植入物，其中所述柔性外壳包括圆形形状。
7.根据权利要求1所述的能够选择性膨胀的乳房植入物，其中所述柔性外壳包括赋形形状。
8.根据权利要求1所述的能够选择性膨胀的乳房植入物，其中所述能量源包括变化的磁场。
9.根据权利要求1所述的能够选择性膨胀的乳房植入物，其中所述多个导电环不均匀地分布在所述可膨胀材料内，以用于所述能够选择性膨胀的乳房植入物的可选择成形。
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