CN111683624A - 用于医疗植入物的网状袋及其使用方法 - Google Patents
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Abstract
本发明公开了网状袋的实施方式,网状袋包括网状壁,该网状壁限定一端具有开口的外壳。该网状袋还包括束带,该束带构造成在被抽拉时闭合开口,以防止外科植入物离开外壳。该网状袋还可以包括从网状壁延伸的网状凸片,该网状凸片提供的表面用于将网状袋缝合到患者身体的内表面。该网状袋还包括从网状壁延伸的股线和附接到股线末端的针。股线可被构造成在被抽拉时围绕外科植入物紧固网状壁。
Description
相关申请的交叉引用
本申请要求于2017年11月13日提交的美国临时专利申请62/585,402的优先权,其全部内容通过引用合并于此。
技术领域
本公开总体上涉及用于植入物的网状覆盖物,并且更具体地,涉及用于植入物的网状袋及其使用方法。
背景技术
本公开涉及外科手术植入装置的领域。本公开的各方面特别涉及使用可生物吸收的柔性网状袋来支撑和稳定乳房假体。
由硅树脂或盐水组成的合成植入物通常用于隆胸和胸再造,但是在两种情况下,仅软组织包膜有时不足以将植入物保持在适当的位置。此外,在许多情况下,当使用圆形植入物时,难以获得或维持解剖学上合适的乳房形状。由于天然组织的这些缺陷,有时需要修复手术以重塑、重新定位、提起或以其他方式修改植入物和/或假体周围组织。如果为乳房植入物提供了额外的、定型的、局部定位的支撑结构,则可以避免修复手术。有时使用吊带或吊床结构的内部胸罩为乳房植入物提供额外的支撑。内部胸罩吊床的常用材料是手术网和脱细胞组织。
这些内部胸罩为乳房植入物提供了额外的支撑,但是仍然需要改善的支撑和稳定性以确保在隆胸和再造手术中获得持久的结果。
附图说明
尽管所附权利要求书特别地阐述了本技术的特征,但是根据结合附图的以下详细描述,可以最好地理解这些技术:
图1是根据一个实施例构造的网状袋的顶视图。
图2是网状袋的开口和束带的透视特写。
图3是网状袋的后透视图。
图4是网状袋的后视图。
图5和图6描绘了根据实施例在手术中使用网状袋的方法。
具体实施方式
本公开总体上涉及用于将植入物与患者的身体固定的网状袋。根据各种实施例,网状袋包括网状壁,该网状壁限定了具有开口的外壳。该网状袋还包括束带,该束带构造成在被拉出时闭合开口,以防止外科植入物离开外壳。该网状袋还可以包括从网状壁延伸的网状凸片,该网状凸片提供用于将网状袋缝合到患者身体的内表面的表面。所述网状袋可进一步包括从网状壁延伸的股线和附接到股线末端的针。股线可被构造成在被抽拉时围绕外科植入物紧固网状壁。
本文公开的网状袋提供了额外的支撑和稳定性。将植入物插入网状袋并将接片缝合到胸壁后,在愈合过程中,360度网状外壳可将植入物定位在局部,并减轻周围软组织的重量。后一种益处在乳房切除术后乳房再造中特别有利,乳房再造通常在给剩余的皮瓣供血不充分的情况下进行。网状小袋的外壁上的凸片提供了额外的表面积,以缝合和支撑被包裹的乳房植入物,而没有通过直接穿过小袋的外壁进行缝合而刺穿植入物的风险。与仅在颅尾平面中提供支撑和定位的吊床方法相比,本文所述的网状袋方法可以完全承受植入物的重量,迫使植入物成所需的形状,并使植入物在中外侧定位。此外,对于给定的植入物和软组织缺损,与将定制的吊床或吊索从平板上切掉然后将其剪裁起来放入适当大小和形状的半口袋中相比,将植入物放入预先成型的袋中,将其束紧并缝合少量的标签,将更省时。
网状袋的各种实施例包括围绕开口的一个或多个束带,可以抽拉该束带以闭合开口。使用束带设计可使网状袋的壁与植入物齐平。这种设计有助于消除材料堆积和产生的气袋,气袋可导致细菌感染和肿胀。
本文所述的网状袋的实施方案不具有可吸收的涂层。相反,本文所述的实施方案完全由生物可吸收材料构成。整个设备由可生物吸收的材料制成,可以减少非生物可吸收的网状植入物常见的并发症和感染。
本文所述的各种实施例为患者提供了隆胸或再造的持久效果,从而减少了后续修复手术的需要。
参考图1至图4,示出了根据实施例的网状袋。通常用100标记的网状袋包括网状壁102,该网状壁围绕并限定外壳104。当网状壁102完全膨胀时,其形状为椭球形(spheroid),但构造成在使用时与植入物的形状一致。网状壁102在端部108处具有开口106,植入物(例如,乳房植入物或其他乳房假体,例如组织扩张器)可以通过开口106插入。
在实施例中,网状壁102由围绕网状袋100的纵向轴线A的第一系列的圆形帘线110组成,并且第一系列的圆形帘线110在网状袋相对的端108和112处的圆周最小,并且在网状袋100的中心114周围的圆周处最大。网状壁102还由第二系列的圆形帘线116组成,第二系列的圆形帘线116定向在与第一系列的圆形取向平面垂直的平面中。网状壁102还由第三系列的圆形帘线118组成,第三系列的圆形帘线118定向在与第一组圆形帘线110和第二系列的圆形帘线的取向平面垂直的平面中116。第二和第三组圆形线116和118在它们被开口106中断的地方是不连续的。
在实施例中,网状壁102包括多孔材料,例如编织外科网。它被配置为独立于手术植入装置的存在而保持三维结构,例如乳房形状或球形(sphere-shape)。它可以由可拉伸的材料制成,该材料允许开口106膨胀并且随后开口106收缩到或接近其原始尺寸。网状壁102可以由可生物吸收的材料制成,例如聚-(对)-二恶烷酮(poly-(p)-dioxanone)、聚三亚甲基碳酸酯(poly trimethylene-carbonate)、聚乙交酯(polyglycolide)等。它也可以由生物材料组成,包括复杂的细胞外基质和简单的聚合物,例如P4HB、纤维蛋白(fibroin)等。
根据实施例,紧靠并围绕开口106的是束带120,该束带120在从网状壁102上拉开时,足以闭合开口106,以防止植入物离开外壳106。如图2所示,束带120通过套筒122(其可以由实心材料制成或可以由一系列螺纹环制成)固定到网状壁102上。束带120具有第一自由部分124和第二自由部分126,每个自由部分相对套筒122是自由的。为了封闭开口106,将自由部分124和126中的一个或两个从网状壁102上拉开。代替套管122,束带120可以经由沿着开口106的边缘的一个或多个开口附接至网状壁102(例如,具有足够的尺寸以使得绳索或细绳可以穿过并被抽拉,以抽绳束带或钱包绳的方式封闭小袋的开口)。
在实施例中,开口106周围的材料具有由网状壁102的纺织品特性赋予的弹性特性(例如,在开口的边缘处),使得可以通过强制加宽打开并插入植入物,而将外科植入物放置在外壳106中。然后,通过缩回开口来捕获植入物。该实施例可以包括或可以不包括束带。
如图1至图4所示,在实施例中,网状袋100包括一个或多个延伸部,在图中显示为第一网状凸片(tab)128和第二网状凸片130。网状凸片128和130在网状袋100的最宽点的两侧附接到网状壁102。网状凸片128和130提供用于将网格袋100缝合到患者的内部(例如,内部组织)的表面。网状凸片的孔径和图案可以根据实施例而变化。在附图中示出了两个网状凸片,但是在其他实施例中附加的网状凸片也是可能的。在该实施例中,网状凸片128和130放置在穿过网状袋100的椭球形形状的交叉十字的一半(或大约一半)的同一平面上。其他实施例可以具有沿网状袋直径的截面长度放置在不同的平面上或在不同的交叉处的网状凸片。
在实施例中,网状袋100包括附接到网状壁102的集成股线132。股线132具有附接到其末端的针134。股线132可以用于将网状袋100缝合到患者的内部部分。根据实施例,股线132连接到网状壁102的一根或多根绳上(具有套筒构造,例如束带120,或不具有套筒),从而抽拉股线132(例如,在使用时缝合)股线的作用是使外壳104更小,从而使网状壁102更紧密地配合到植入物上。网状袋100可具有多个带有针的集成线。
参照图5和图6,现在将描述如何使用网状袋100的示例。通过开口106将诸如乳房植入物之类的医疗装置插入网状袋100中。在将医疗装置插入之后,它将被完全包封在网状壁104内。抽拉束带120,使得随着束带(drawstring)120被拉得更紧直到其拉紧,开口106变得越来越小。然后拉紧住束带120。由于网状壁102的弹性反冲,植入物可被保持在网状袋100内,或者通过用束带120封闭开口106而更牢固地固定。以这种方法,网状壁102的静止形状可迫使圆形植入物被封闭在其中,以呈现更自然的乳房形状。
然后,可以将网状袋100内的植入物放置在适当的位置和适当的组织平面上,就像在没有网状袋100的情况下那样(例如,在前胸乳房再造的情况下,在皮肤与胸膜/筋膜之间)。然而,在放置之后,可以将集成的网状凸片128和130直接缝合到软组织(例如,胸壁或其他组织-例如胸膜筋膜-的内部)上,以便在愈合过程中保持其位置。将网状袋100缝合到胸壁提供了一种无需依赖软组织操纵就可以定位植入物的方法,并且远离乳房假体的凸片的位置使在此期间对乳房假体意外损坏的风险最小化。通过使用集成针134(或多个针,如果有多个)来缝合到胸壁,可以进一步促进定位和塑形,通过拧紧附有集成针的股线(例如,集成式纤维),该集成针(如果如上所述与网状壁102集成在一起)也可以根据需要缝合或剪裁网状袋100。最后,上覆层(例如,皮肤和皮下组织)被封闭。植入物的重量由网状袋100和与其缝合的软组织承受,而不是由覆盖它的皮肤包膜承受。
根据实施例,网状袋100如下形成:1)网状片通过经编、静电纺丝或其他纺织技术形成。2)将导热模具或芯棒成型为所需的椭球体或乳房形状。3)将网状物缠绕并退火至模具或芯棒,以达到所需的椭球体或乳房形状。
网状袋100可以在乳腺外科手术的多个领域中使用,例如,直接植入、前胸、用于乳房切除术缺陷的乳房再造。在这种情况下,可以通过在乳房切除术之前乳房组织所在的空间中,将假体乳房植入物放置在胸大肌与上覆皮肤之间的平面内来进行乳房模型的重建。例如,在图5中,示出了网状袋植入物500(根据前述实施例中的一个或多个配置),其被原位放置在人乳房中,并且还示出了牵开器502。在图6中,示出了网状袋植入物600(根据前述实施例中的一个或多个来配置)原位设置在人乳房中,其中网状凸片602缝合在适当位置。图6中所示的各种组织包括皮肤和皮下组织604、胸大肌606、肋骨608和肋间610。
应当理解,本文描述的实施方式应仅在描述性意义上考虑,而不是出于限制的目的。每个实施例中的特征或方面的描述通常应被认为可用于其他实施例中的其他类似特征或方面。本领域普通技术人员将理解,在不脱离其精神和范围的情况下,可以在形式和细节上进行各种改变。
Claims (20)
1.一种用于将外科植入物保持在患者体内的网状袋,该网状袋包括:
网状壁,限定一端具有开口的外壳;以及
束带,构造成在抽拉时闭合所述开口,以防止所述外科植入物离开所述外壳。
2.根据权利要求1所述的网状袋,还包括从所述网状壁延伸的网状凸片,所述网状凸片提供了表面用于将所述网状袋缝合到患者身体的内表面。
3.根据权利要求1所述的网状袋,还包括从所述网状壁延伸的股线。
4.根据权利要求3所述的网状袋,还包括附接到所述股线的末端的针。
5.根据权利要求1所述的网状袋,还包括从所述网状壁延伸的一根或多根股线,其中,所述一根或多根股线中的每根被构造成当被抽拉时围绕所述外科植入物收紧所述网状壁。
6.根据权利要求1所述的网状袋,其中,所述网状壁包括围绕所述网状袋的纵向轴线的一系列圆形帘线。
7.根据权利要求6所述的网状袋,其中,所述网状壁包括第二系列圆形帘线,所述第二系列圆形帘线所在的平面垂直于所述一系列圆形帘线的平面。
8.根据权利要求1所述的网状袋,其中,当所述网状壁完全膨胀时,所述外壳的形状为椭球形。
9.根据权利要求1所述的网状袋,其中,所述网状壁由可拉伸材料制成,所述可拉伸材料允许所述开口的膨胀和收缩。
10.根据权利要求1所述的网状袋,其中,所述网状壁由选自以下组成的组的材料制成,包括:聚-(对)-二恶烷酮、聚三亚甲基碳酸酯、聚乙交酯、P4HB和纤维蛋白。
11.一种用于将外科植入物保持在患者体内的网状袋,所述网状袋包括:
网状壁,其限定了具有开口的外壳,所述外壳在闭合时防止外科植入物离开;以及
股线,所述股线从所述网状壁延伸,其中所述股线构造成在被抽拉时围绕所述外科植入物收紧所述网状壁。
12.根据权利要求11所述的网状袋,还包括附接到所述股线的末端的针。
13.根据权利要求11所述的网状袋,其中,所述股线构造成当被抽拉时围绕所述外科植入物紧固所述网状壁。
14.根据权利要求11所述的网状袋,其中,所述网状壁包括围绕所述网状袋的纵向轴线的一系列圆形帘线。
15.根据权利要求11所述的网状袋,其中,所述网状壁包括第二系列圆形帘线,所述第二系列圆形帘线所在的平面垂直于所述一系列圆形帘线的平面。
16.根据权利要求11所述的网状袋,还包括从所述网状壁延伸的网状凸片,所述网状凸片提供的表面用于将所述网状袋缝合到患者身体的内表面。
17.如权利要求11所述的网状袋,还包括束带,所述束带构造成在抽拉时闭合所述开口,以防止所述外科植入物离开所述外壳。
18.一种将外科植入物固定在患者体内的方法,该方法包括:
通过网状袋的网状壁的开口插入所述植入物,所述网状壁限定了外壳;
在所述开口附近抽拉一束带以关闭所述开口,从而防止所述植入物离开所述外壳;
将所述网状袋插入患者体内;以及
将所述网状袋缝合到患者体内的组织。
19.根据权利要求18所述的方法,其中将所述网状袋缝合包括将从所述网状壁延伸的网状凸片缝合到所述组织。
20.根据权利要求18所述的方法,其中将所述网状袋缝合包括将从所述网状壁延伸并与之成一体的股线缝合到所述组织,从而围绕所述植入物拉紧所述网状袋。
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US20190142573A1 (en) | 2019-05-16 |
KR20200078644A (ko) | 2020-07-01 |
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US20190343620A1 (en) | 2019-11-14 |
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US10363127B2 (en) | 2019-07-30 |
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