CN107427332B - 具有胸部附接件的组织扩张器 - Google Patents
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Abstract
本发明公开了一种乳房组织扩张器装置,其包括:具有前侧(104)和后侧(102)的可充胀壳体(110),所述前侧具有在顶点(109)处相交的上极部分(106)和下极部分(108)和用于接收通过其的流体以使扩张器充胀的注射孔口(112);以及基本上平坦的附接翼片(116),所述附接翼片联接到壳体的后侧,并且沿向下方向延伸超出壳体的下边缘(128)距离D,使得附接翼片可围绕下边缘并向上延伸以覆盖壳体的前侧的至少一部分。
Description
技术领域
本发明整体涉及可植入组织扩张器的领域,并且更具体地涉及具有用于在扩张期间固定胸肌的附接装置的可植入乳房软组织扩张器。
背景技术
组织扩张器是植入皮下然后逐渐充胀以拉伸外层组织的装置。此类扩张器用于形成接收永久假体的袋,并且/或者用于产生增加的皮肤表面区域,使得皮肤可用于移植或重建。
在乳房植入物的情况下,组织扩张器用于产生将最终接收永久性乳房植入物的乳房袋。这些扩张器通常由硅树脂聚合物壳体形成,并且以塌缩状态植入。在植入之后,随时间推移盐水或一些其他流体例如通过注射孔口周期性地注入扩张器中直到获得期望尺寸的袋。
乳房切除术后的乳房重建通常分两个阶段进行。组织扩张器在第一阶段中使用,并放置在胸大肌的一部分的下方。为了发生这种情况,胸大肌的下部边缘必须沿其下边缘被释放,并且使用外科网片或无细胞真皮基质(ADM)重新附接。如果这种网片或ADM在扩张过程中提早分离,则其可导致肌肉在组织扩张器的顶部上方缩回或反弹;有时被称为“窗口阴影”的事件。这是不期望的,因为它可导致在仅被皮肤覆盖而不是被皮肤和肌肉的组合覆盖的那些区域中的下极中的可见缺陷。窗口阴影还可导致患者的不适和不充分的扩张过程。这将导致外科重新干预以重新附接胸肌的下边缘。
因此,可期望提供一种消除或大大减少对网片或ADM的需要的扩张器,同时提供防止窗口阴影的手段。
发明内容
提供一种乳房组织扩张器,其包括具有前侧和后侧的可充胀壳体,其中所述前侧具有在顶点处相交的上极部分和下极部分和用于接收通过其的流体以使扩张器充胀的注射孔口。扩张器还包括基本上平坦的附接翼片,所述附接翼片联接到壳体的后侧,并且沿向下方向延伸超出壳体的下边缘距离D,使得附接翼片可围绕下边缘并向上延伸,以覆盖壳体的前侧的至少一部分。
扩张器可向上延伸以覆盖壳体的下极和顶点,并且可具有大于或等于8cm的距离D。
根据一个实施方案,当附接翼片围绕壳体的下边缘并向上延伸时,附接翼片的外周边基本上位于壳体的外周边内。
扩张器的壳体可由硅树脂构成,并且附接翼片可由网状材料诸如聚丙烯网片构成。
根据一个另选实施方案,网状材料在两个侧面上均用硅树脂封装。
在另一个实施方案中,扩张器还包括联接到壳体的后侧并从壳体向外延伸的至少一个固定突出部,并且还可包括对应于每个固定突出部的至少一个开孔。在另一个实施方案中,至少一个开孔被定位成使得当附接翼片围绕下边缘并向上延伸跨过壳体的前侧的至少一部分时,对应的固定突出部可自由地穿过开孔。至少一个开孔可还具有与对应的固定突出部的尺寸和形状基本上类似的尺寸和形状。
在另一个实施方案中,附接翼片还包括在其中的多个孔。
还提供一种用于组织扩张的方法,该方法包括以下步骤:提供乳房组织扩张器,乳房组织扩张器具有可充胀壳体以及基本上平坦的附接翼片,所述可充胀壳体具有前侧和后侧,所述前侧具有在顶点处相交的上极部分和下极部分和用于接收通过其的流体以使扩张器充胀的注射孔口,所述附接翼片联接到壳体的后侧,并且沿向下方向延伸超出壳体的下极;将组织扩张器植入女性患者体内,使得后侧抵靠患者的胸壁定位,并且下极部分被定位在上极部分下方,并且使得扩张器被放置在患者的胸肌的一部分的下方;以及将附接翼片从后侧围绕壳体的下边缘缠绕,并且向上跨过壳体的前侧的至少一部分。
壳体还可包括联接到壳体的后侧并从壳体向外延伸的至少一个固定突出部,并且附接翼片还可包括在其中的对应于至少一个固定突出部的至少一个开孔。在缠绕步骤期间,至少一个固定突出部自由地穿过至少一个对应的开孔。
在一个实施方案中,壳体由硅树脂制成,并且附接翼片由网状材料制成。在另一个实施方案中,附接翼片的网状材料在两个侧面上均用硅树脂封装。
另外提供了一种组织扩张器,该组织扩张器具有:可充胀壳体,所述可充胀壳体具有前侧和后侧,其中所述前侧具有用于接收通过其的流体的注射孔口;以及基本上平坦的附接翼片,所述附接翼片联接到壳体的后侧,并且沿向下方向延伸超出壳体的下边缘至少8cm的距离。
本发明的这些目标和其他目标、特征和优点可通过结合附图阅读对以下示例性实施方案的详细描述而显而易见。
附图说明
图1a和图1b是根据本公开的扩张器的前视图和侧视图;
图2是示出图1的扩张器在患者体内的定位的透视图;
图3是示出图1的扩张器相对于患者的胸肌的定位的侧视图;以及
图4和图5是图1的扩张器的另选实施方案的前视图。
具体实施方式
图1a和图1b示出了根据本公开的示例性扩张器100的前视图和侧视图。该扩张器具有后侧102和前侧104,后侧102基本上平坦地抵靠患者的胸壁放置,前侧104在植入时从胸壁面向外。前侧104包括上极区域106(即,当植入物接收者站立时壳体的上部部分)、下极区域108(即,当植入物接收者站立时壳体的下部部分)和分离上极区域和下极区域的顶点109(对应于乳头在自然乳房中所处的点)。扩张器100的外部壳体110通常由硅树脂材料制成,并且包括注射孔口或其他阀112,盐水或另外的流体随时间推移通过注射孔口或其他阀112注射到由外部壳体110限定的容纳空间中。扩张器壳体110可具有光滑的或带纹理的表面。
扩张器100可包括联接到后侧102并优选地从后侧102延伸的一个或多个固定突出部114。固定突出部114用于帮助外科医生将扩张器固定到胸壁以通常通过使用缝合线等来在扩张期间保持其位置。在这方面,固定突出部进一步防止植入物壳体的意外穿刺。本公开的扩张器还包括基本上平坦的、柔性的附接翼片116,附接翼片116沿向下方向(朝向患者的脚部)从植入物的后侧延伸超出扩张器的外周边118。类似于外部壳体110,该翼片也可以是光滑的或带纹理的。现在结合图1参考图3,附接翼片116延伸超出扩张器的周边距离D,使得当扩张器被植入时,附接翼片可围绕植入物的下边缘128延伸或缠绕,并且向上跨过扩张器的下极的至少一部分,并且到达植入物的前侧,并且在优选的实施方案中,通过缝合或任何其他合适的手段,经过顶点109到其可附接到先前释放的胸肌120的点,如图2中进一步示出的。在优选的实施方案中,距离D为约8cm至18cm,更优选地为12cm。附接翼片通过任何合适的手段诸如硅树脂粘结(未硫化到硫化材料粘结(un-vulcanized to vulcanizedmaterial bonding))联接到植入物的后侧。在所示实施方案中,附接翼片基本上覆盖植入物的整个后侧。这不是所需要的;然而,如上所述,只有它延伸超出壳体的下边缘才是重要的。
附接翼片的整体形状被设计成在使用时严密地遵循扩张器的形状。附接翼片具有外周边122,外周边122限定其整体形状,并且被设计成使得当如上所述围绕植入物的前侧缠绕时,附接翼片的外周边122严密地遵循扩张器的外周边,如图2中最佳示出。优选地,附接翼片的外周边将稍微地位于壳体的外周边内。然而,可调整附接翼片的端部,使得其与胸肌的端部对准。
再次参考图1,如果扩张器装置包括如图所示的固定突出部114,则附接翼片116还包括在其中的对应的开孔124。开孔124优选地具有基本上对应于如图所示的固定突出部的形状的形状并且定位在附接翼片上,使得当附接翼片围绕植入物的前侧缠绕时,附接翼片可在没有任何障碍的情况下自由地越过固定突出部。在这方面,开孔的形状不必直接对应于固定突出部的形状,而是至少必须具有足够的尺寸、形状和位置,使得当附接翼片围绕植入物的前侧缠绕时,固定突出部可自由地穿过开孔。图5示出了具有不同形状的固定突出部和附接翼片开孔的扩张器装置的另选实施方案。对于本领域技术人员显而易见的是,这些部件的任何合适的构型都在本公开的范围内。
图4示出了另选实施方案,其中附接翼片还包括多个附加开孔126。开孔可具有多个尺寸/形状,并且允许流体流动。
根据本公开可使用任何已知的扩张器。例如,由Mentor Worldwide LLC(SantaBarbara,California)制造和销售的具有突出部的CPX4轮廓外形组织扩张器(CPX4Contour Profile Tissue Expander)就特别适合。附接翼片可由任何合适的可植入增强材料诸如VicrylTM(聚乳糖910)或(聚对苯二甲酸乙二酯)制成。网片可封装在硅树脂中。在优选的实施方案中,附接翼片是在两个侧面上均由硅树脂材料封装的网片。
虽然本文已结合附图描述了本发明的示例性实施方案,但是应当理解本发明不限于那些明确的实施方案,并且在不背离本发明的保护范围和实质的情况下,本领域的技术人员在此可实现各种其他改变和修改。
Claims (13)
1. 一种乳房组织扩张器装置,包括:
可充胀壳体,所述可充胀壳体具有前侧和后侧,所述前侧具有在顶点处相交的上极部分和下极部分和用于接收通过其的流体以使所述扩张器充胀的注射孔口;以及
基本上平坦的附接翼片,所述附接翼片联接到所述壳体的所述后侧,并且沿向下方向延伸超出所述壳体的下边缘距离D,使得所述附接翼片可围绕所述下边缘并向上延伸以覆盖所述壳体的所述前侧的至少一部分。
2.根据权利要求1所述的扩张器,其中所述附接翼片可向上延伸以覆盖所述壳体的所述下极和所述顶点。
3.根据权利要求1所述的扩张器,其中距离D大于或等于8cm。
4.根据权利要求1所述的扩张器,其中当所述附接翼片围绕所述壳体的所述下边缘并向上延伸时,所述附接翼片的外周边基本上位于所述壳体的外周边内。
5.根据权利要求1所述的扩张器,其中所述壳体由硅树脂构成,并且其中所述附接翼片由网状材料构成。
6.根据权利要求5所述的扩张器,其中所述网状材料为聚丙烯网片。
7.根据权利要求5所述的扩张器,其中所述网状材料在两个侧面上均用硅树脂封装。
8.根据权利要求1所述的扩张器,所述扩张器还包括联接到所述壳体的所述后侧并从所述壳体向外延伸的至少一个固定突出部。
9.根据权利要求8所述的扩张器,其中所述附接翼片还包括在其中的对应于所述至少一个固定突出部中的每个的至少一个开孔。
10.根据权利要求9所述的扩张器,其中所述附接翼片中的所述至少一个开孔被定位成使得当所述附接翼片围绕所述下边缘并向上延伸跨过所述壳体的所述前侧的至少一部分时,所述对应的固定突出部可自由地穿过所述开孔。
11.根据权利要求10所述的扩张器,其中所述至少一个开孔具有与所述对应的固定突出部的尺寸和形状基本上类似的尺寸和形状。
12.根据权利要求11所述的扩张器,其中所述附接翼片还包括在其中的多个孔。
13.一种组织扩张器,包括:
具有前侧和后侧的可充胀壳体,所述前侧具有用于接收通过其的流体的注射孔口;
基本上平坦的附接翼片,所述附接翼片联接到所述壳体的所述后侧,并且沿向下方向延伸超出所述壳体的下边缘至少8cm的距离,使得所述附接翼片可围绕所述下边缘并向上延伸以覆盖所述壳体的所述前侧的至少一部分。
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PCT/US2016/017509 WO2016144475A1 (en) | 2015-03-12 | 2016-02-11 | Tissue expander with pectoral attachment |
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CN107427332B true CN107427332B (zh) | 2020-08-04 |
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ITUB20152200A1 (it) * | 2015-07-15 | 2017-01-15 | Solidago Ag | Protesi autoportante per interventi di chirurgia plastica e ricostruttiva |
BR112018016211A8 (pt) | 2016-02-09 | 2023-02-23 | Estab Labs Sa | Transponders, conjunto de portas integrado, métodos e sistema para transmitir um sinal específico de transponder |
US10945831B2 (en) | 2016-06-03 | 2021-03-16 | Musculoskeletal Transplant Foundation | Asymmetric tissue graft |
USD856517S1 (en) | 2016-06-03 | 2019-08-13 | Musculoskeletal Transplant Foundation | Asymmetric tissue graft |
IL307400A (en) | 2016-10-28 | 2023-12-01 | Estab Labs S A | Tissue expanders, production methods and patterns thereof |
US10182904B2 (en) | 2017-02-21 | 2019-01-22 | Biosense Webster (Israel) Ltd. | Heat expandable breast implant using induction heating |
KR102144312B1 (ko) * | 2018-06-18 | 2020-08-14 | 서울대학교병원 | 유방 재건용 조직 확장기 |
US10813743B2 (en) | 2018-09-07 | 2020-10-27 | Musculoskeletal Transplant Foundation | Soft tissue repair grafts and processes for preparing and using same |
USD895812S1 (en) | 2018-09-07 | 2020-09-08 | Musculoskeletal Transplant Foundation | Soft tissue repair graft |
USD896383S1 (en) | 2018-09-13 | 2020-09-15 | Allergan, Inc. | Tissue expansion device |
US11160630B2 (en) | 2018-09-13 | 2021-11-02 | Allergan, Inc. | Tissue expansion device |
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WO2022011319A1 (en) * | 2020-07-10 | 2022-01-13 | Allergan, Inc. | Tissue expansion device with fluid collection |
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AU2016229479A1 (en) | 2017-08-31 |
CA2977040A1 (en) | 2016-09-15 |
JP2018512248A (ja) | 2018-05-17 |
EP3267941A1 (en) | 2018-01-17 |
US10799313B2 (en) | 2020-10-13 |
BR112017018672A2 (pt) | 2018-04-17 |
BR112017018672B1 (pt) | 2022-06-28 |
US20160262835A1 (en) | 2016-09-15 |
EP3267941B1 (en) | 2021-06-16 |
JP6847872B2 (ja) | 2021-03-24 |
CN107427332A (zh) | 2017-12-01 |
AU2016229479B2 (en) | 2020-07-02 |
WO2016144475A1 (en) | 2016-09-15 |
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