CN107407620A - 用于定位、测绘和显微、测量瘤形成的辅助装置 - Google Patents
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Abstract
本发明的装置涉及用于定位、测绘和显微测量瘤形成(特别是乳房外科手术标本中的微钙化)的辅助装置，该辅助装置与放射学程序相关。
Description
技术领域
本发明涉及其与放射学程序相关的用于定位、测绘和显微测量瘤形成(特别是乳房外科手术标本中的微钙化)的辅助装置。
本发明的装置发挥了许多有价值的功能，从而允许使外科手术标本(切除的结果)：
(1)在围手术期期间被适当固定来进行放射线照相术，从而允许精确定位微钙化并对外科手术扩增的需要作出决定，
(2)以其进行射线照相时相同的位置和形状，通过浸入到甲醛中而被有效地保存；
(3)根据射线照相的质量和留在标本中的阵列(matrix)印记，提供对微钙化的测绘(mapping)和对肿瘤大小的显微测量以用于准确的病理分期。
背景技术
乳腺癌占全世界所诊断的所有癌症的10％，并且是女性中最常见的癌症，占该类肿瘤的约25％。
使用乳房X线摄影术(钼靶摄影，mammography)作为风险人群筛查方法允许通过预先诊断、简化治疗及其副作用而大大降低疾病的死亡率。被诊断为早期且限于乳腺肿瘤的患者处于良好的预后分组中，并且可以免于更激进的治疗。大约25％的癌症病例在其原位阶段(即，当其尚未侵入乳房基质)被诊断出来，并且在技术上被认为是可治愈的。在年龄为50-69岁的人群中，乳房X线摄影筛查取得的进展最为明显，其中每1000名每年接受检查的妇女中，6至9例乳腺癌死亡被预防。
现今乳腺癌具有五种治疗选择，即：外科手术、放射治疗、激素治疗(hormonioterpia)、抗HER2治疗和化疗。每个患者根据其肿瘤特征接受这些方案的特定组合。肿瘤大小是该决定中最重要的变量之一。称为第1阶段(最多2厘米)的小肿瘤可以被分为T1a(最多5mm)、T1b(5至10mm之间)和T1c(10至20mm之间)。这些类别限定了化疗的指征。
最经常由乳房X线摄影术检测的疑似癌症发现物之一是聚集的微钙化而没有相关的肿瘤团块。这些微钙化可代表侵入性癌区(通常在早期阶段)、原位癌或两者，并且仅显微检查可以进行明确的诊断和肿瘤测量。与可触知的团块不相关的微钙化代表了一类乳房病变，其需要一系列独特的术前和术后评估来确保诊断的质量：
1–通过穿刺或放射性标记的微钙化术前定位；
2-围手术期期间的外科手术标本的放射线照相，以确保整个感兴趣区域已被手术切除；该步骤是主要关注的对象，这是因为快速有效的外科手术决定取决于该步骤的质量；
3-立即将外科手术标本固定在合适体积的甲醛中，以确保显微镜检查的形态学质量和用于预测性和预后性分子测试的DNA和蛋白质的保存；
4–外科手术标本的组织学测绘，以允许正确估算肿瘤的大小。
现有技术中具有仅适用于这些需求中的一部分的装置，诸如国际申请WO2014039727，但其不适用于例如与甲醛接触和显微测量。
出于上述要求，创建了一种辅助装置，其用于定位、测绘和显微测量肿瘤装置，操作简单高效，与现有技术中存在的其他装置相比具有优势。
发明内容
下面对本发明的描述是为了便于理解，而不对本发明施加除了所附权利要求中表达的那些限制以外的任何限制。
本发明涉及一种用于定位、测绘和测量瘤形成的辅助装置，其包括由无毒材料制成的、完全或基本上透放射线的上板和下板，在该上板和下板之间放置有外科手术标本，例如由外手术切除所得的乳房碎片。放射线透过性的程度应允许同时显示微钙化和测绘阵列。
所述上板包括两个配合的部件，即框架和可移动的中央盖(例如相对于框架倾斜或滑动的中央盖，该中央盖具有针对该目的所必需的可机械运动的工具或装置)，并且优选地，框架完全围绕中央盖。至少该倾斜的盖由完全或基本上透放射线的材料(例如甲基丙烯酸甲酯型塑料)制成。盖是可移动的，并且可以保持关闭(因此具有适当的封闭工具)，或者是打开的从而使框架的中央区域暴露，这使得线的阵列露出，该线的阵列优选地具有低放射不透明度、柔性以及对诸如甲醛等产品具有高度化学耐受性，例如尼龙。线的阵列形成规则尺寸和间隔的方格(square，正方形)。所述线的阵列物理地位于上板的盖子的下面，基本上与其平行，使得其可以与容纳在上板和下板之间的外科手术标本物理接触。
所述下板优选为实心的，至少在其中央区域中由也完全或基本上是透放射线的并且耐化学品(如甲醛)的材料(例如甲基丙烯酸甲酯型塑料)构成，该甲基丙烯酸甲酯型塑料优选是视觉上透明的。
在被移动而彼此靠近之后，所述上板和下板是基本上平行的，以便(诸如借助与螺栓相结合的螺母，该螺栓的纵向杆从例如在上板的框架边缘处和在下板边缘上的基本上对准的开口穿过两个板)一起固定外科手术标本。被设计成将两板组合在一起并固定的任何其他等效近似工具都是合适的，如本领域已知的，其被设计成适当地固定外科手术标本，例如，耐诸如甲醛的化学品的紧固夹具、军士夹具、具有带的棘轮等。
上板和下板之间的接近以及线的阵列的线的柔性用于将外科手术标本固定在所述板之间。尽管相互靠近，但由于它们之间所固定的外科手术标本的体积，上板和下板并不会碰到。
本发明的装置可以具有用于使该装置倾斜的工具(例如)以获得将装置以45度定位，以便在射线照相程序期间改变外科手术标本的位置。
以下描述涉及使用本发明装置的形式以及使用本发明的装置所提供的优点。
在从接受了乳房部分或全部切除术的患者中取出外科手术标本后，该标本被放置在装置的下板上，其位置相对于上板的盖基本居中，并且将上板放置于其上，其中上板的盖处于关闭位置。
然后通过接近工具(诸如，将螺母逐渐拧在螺栓上)将上板和下板压在一起，以便在线的阵列的分散的弹性容纳后将外科手术标本牢固地固定，而又没有太过压缩，该太过压缩可能破坏或基本上改变标本的物理结构。
因此，固定在本发明装置的上板和下板之间的外科手术标本尽快在适合于这种目的(特别是用于检测微钙化而非可触知的团块)的器材中进行射线照相程序。在射线照相记录中，线的阵列能够实现对微钙化位置的记录。优选地，但不排除任何其他可替换的方案，线由低放射不透明材料制成，使得即使是位于两线的连接处下方的最小微钙化都可以通过放射学程序检测到。
还优选地，存在位于上板的框架上的(例如带有字母和数字的)可视标记，从而使得在测绘期间能够可靠地标明微钙化所在的方格。
在放射线照相后，打开上板的盖，并将装置完全浸入甲醛中。与现有技术的其他装置不同，与不打开的上板相比，打开上板的盖使得外科手术标本与甲醛更好接触，从而允许针对以下步骤的适当保护：组织处理、组织切割、微观解释(microscopic interpretation)和互补分子测试的应用。
将标本设置为与线的阵列接触的另外的优点引起该线的阵列在标本表面上的物理印记，从而还允许利用多种涂料颜色标记感兴趣的方格，使得在将标本从装置移开时不会丢失形态测量信息。
特别地，本发明装置的上板和下板具有任何所需尺寸的相同宽度和长度。
优选地，本发明装置的所有部件具有适合于其将被暴露于的放射性器材类型的尺寸以及它们受到的机械力，从而保持最佳的透放射线性，以及其中必要的是化学性耐与甲醛接触。
优选地，本发明装置的所有部件都是根据常规医院和实验室程序可洗涤和可灭菌的，以便可以重复使用本发明的装置。
本发明的另一方面是所述装置的用途，其特征在于包括以下步骤：
(a)将外科手术标本放置在所述上板和下板之间；
(b)使所述板彼此靠近，从而借助所述接近工具按压其间的外科手术标本，使得所述线的阵列与外科手术标本接触；
(c)将装置暴露于射线照相程序，其中所述可移动盖处于关闭位置；
(d)将装置浸入甲醛中适当的时间，其中所述可移动盖处于打开位置；
(e)随着接近工具的松动，移动所述板使彼此分开，从而使外科手术标本能够被取出，使其可供稍后评估。
附图说明
下面提及的附图表示本发明的具体实施方式，而不施加除了权利要求中所包含的限制之外的任何限制。
-图1A-本发明的用于定位、测绘和显微测量瘤形成的辅助装置(10)的具体实施方式的上板(15)的俯视图；
-图1B-图1A中所示的上板(15)的盖(20)的俯视图；
-图1C-图1A中所示的上板(15)的框架的俯视图；
-图2-本发明具体实施方式的下板(45)的俯视图；
-图3-连接本发明装置(10)的具体实施方案的上板(15)和下板(45)的一套螺栓(50)和螺母(55)的侧视图；
-图4-本发明装置(10)的具体实施方式的透视图，其中上板(15)的盖(20)是关闭的；
-图5-本发明装置(10)的具体实施方式的透视图，其中上板(15)的盖(20)是打开的。
-图6-位于盖(20)下方的线的阵列(35)的可替换的实施方案中的上板(15)的俯视图。
实施例
作为本发明的具体实施方式的说明，给出了借助附图来描述的以下实施例，而不对本发明施加除了所附权利要求中包含的那些限制之外限制。
本发明的装置10包括两个配合的板，一个上板15和一个下板45，具有图1A、图1B、图1C和图2中呈现的细节。板的尺寸为21cm×21cm(宽度x长度)。
上板15包括两个配合部件，即框架40和倾斜的中央盖20(尺寸为15cm×15cm)，所述盖20通过铰链25与框架40配合，并且在非限定性基础上通过锁闭件30的方式保持关闭。
上板15的框架40和中央盖20由透放射线的丙烯酸树脂制成，厚度分别为10mm和5mm。
具有低放射不透明度的细尼龙线(直径测量为0.6mm)的阵列35与上板的框架40结合，处于中央盖20正下方。在该实施例中，阵列为14股×14股，从而创建了尺寸为1cm×1cm的多个方格。在该实施例中，如在图6中可见的，阵列由彼此垂直延伸、穿过框架40的孔40'的两股线A和B构成，以形成呈方格的网格。
下板45是实心的，由丙烯酸树脂制成，具有与上板的轮廓相同的尺寸21cm×21cm，且厚度为10mm。
如还借助图3可见的，两个板通过由聚甲醛制成的4套螺栓50和螺母55彼此接近，每个螺栓50通过位于板(15和45)角部的(板15的)孔16和(板45的)孔16'而穿过板(15和45)。该图仅用于说明接近工具，因为在使用本发明的装置10时，板15和45不接触。
图5和图6示出，拧紧螺母55之后的、容纳有被保持在板15和板45之间的外科手术标本60的装置10。图5示出了关闭的中央盖20，并且图6示出了打开的中央盖20。
如在图5中更清楚可见的，尼龙线的阵列35与外科手术标本60直接接触，使得在接触区域中留下方格印记，该方格辅助组织学检查期间对微钙化的适当的随后定位。
中央盖20保持关闭直到装置10射线照相完毕，并且在装置浸入甲醛时被打开。
已知本领域技术人员基于本文件中包含的信息和实施例可以得到并未具体描述的本发明的具体实施方式，但是这些具体实施方式履行相同或相似的功能以实现相同性质的结果。这样的等价实施方式由所附权利要求涵盖。
Claims (10)
1.一种用于定位、测绘和显微测量瘤形成的辅助装置(10)，其特征在于，包括：
-上板(15)和下板(45)，具有足以将外科手术标本容纳在它们之间的尺寸；
-所述上板(15)包括框架(40)、与所述框架(40)配合的可移动中央盖(20)以及线或股线的阵列(35)；所述阵列(35)位于所述中央盖下面；
-所述上板(15)具有适于将所述可移动中央盖(20)保持关闭的工具(30)；
-所述阵列(35)被定位成与容纳在两个所述板(15)和(45)之间的外科手术标本物理接触；
-所述可移动盖(20)由完全或基本上透放射线的材料制成；
-所述下板(15)至少在中央区域中由基本上透放射线的材料制成，所述中央区域对应于所述上板(15)的可移动盖(20)的尺寸；
-所述上板(15)和下板(45)通过接近工具(50、55)彼此配合以便在所述外科手术标本被固定时所述上板和下板是基本平行的。
2.根据权利要求1所述的装置(10)，其特征在于，所述盖(20)相对于所述框架(40)是倾斜的。
3.根据权利要求1所述的装置(10)，其特征在于，所述阵列(35)的线由具有降低的放射不透明度的尼龙制成。
4.根据权利要求1所述的装置，其特征在于，存在与所述框架(40)相关的标记。
5.根据权利要求1所述的装置(10)，其特征在于，所述部件部分是对化学品耐受的，以便与甲醛接触。
6.根据权利要求1所述的装置(10)，其特征在于，完全或基本上透放射线的材料是甲基丙烯酸甲酯。
7.根据权利要求1所述的装置(10)，其特征在于，在所述上板(15)和下板(40)之间的所述接近工具是一套或多套螺栓(50)和螺母(55)。
8.根据权利要求7所述的装置(10)，其特征在于，所述螺栓(50)和螺母(55)由聚甲醛制成。
9.根据权利要求1所述的装置(10)，其特征在于，另外具有倾斜工具。
10.根据权利要求1至9中任一项所述的用于定位、测绘和显微测量瘤形成的辅助装置(10)的用途，其特征在于，包括以下步骤：
(a)将外科手术标本(60)放置在所述上板(15)和下板(45)之间；
(b)使所述板(15和45)彼此靠近，借助于接近工具(50、55)按压所述板之间的外科手术标本(60)，使得线的所述阵列(35)与外科手术标本(60)接触；
(b)将所述装置(10)暴露于射线照相程序，其中借助于关闭工具(30)使所述可移动盖(20)处于关闭位置；
(c)将所述装置浸入到甲醛中适当的时间，其中借助于移动工具(25)使所述可移动盖(20)处于打开位置；
(d)通过使所述接近工具而将所述上板(15)和下板(45)移动分开，从而使得所述外科手术标本(60)能够被取出。
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| BR102015004994-3A BR102015004994B1 (pt) | 2015-03-06 | 2015-03-06 | Dispositivo auxiliar na localização, mapeamento e mensuração microscópica de neoplasias e seu uso |
| BR102015004994-3 | 2015-03-06 | ||
| PCT/BR2016/050047 WO2016141444A1 (pt) | 2015-03-06 | 2016-03-03 | Dispositivo auxiliar na localização, mapeamento e mensuração microscópica de neoplasias |
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| CN107407620A true CN107407620A (zh) | 2017-11-28 |
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| Country | Link |
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| US (1) | US20180067096A1 (zh) |
| EP (1) | EP3267175A4 (zh) |
| CN (1) | CN107407620A (zh) |
| AU (1) | AU2016228972A1 (zh) |
| BR (1) | BR102015004994B1 (zh) |
| CA (1) | CA2975278A1 (zh) |
| MX (1) | MX2017011211A (zh) |
| WO (1) | WO2016141444A1 (zh) |
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| US10690574B2 (en) * | 2016-05-11 | 2020-06-23 | The Florida International University Board Of Trustees | Chilling apparatus |
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| US5105457A (en) * | 1990-04-19 | 1992-04-14 | Glassman Stuart L | Mammograph x-ray grid |
| GB9307215D0 (en) * | 1993-04-06 | 1993-05-26 | Cellpath Plc | Container |
| US5427742A (en) * | 1994-04-26 | 1995-06-27 | Holland; Wayne | Tissue processing cassette |
| JP2008026097A (ja) * | 2006-07-20 | 2008-02-07 | Teiji Takezaki | 包埋枠状基体籠及びそれを用いた包埋方法 |
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| WO2013192607A1 (en) * | 2012-06-22 | 2013-12-27 | Leica Biosystems Nussloch Gmbh | Tissue sample container and methods |
| US20140065656A1 (en) * | 2012-09-05 | 2014-03-06 | Faxitron Bioptics, Llc | Specimen imaging device and methods for use thereof |
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|---|---|---|---|---|
| DE4000826C2 (de) * | 1990-01-13 | 1996-02-01 | Reinhard Dr Med Bollmann | Vorrichtung zur Aufnahme einer Gewebeprobe zur Lokalisation nicht-tastbarer Mammaveränderungen zur interoperativen Schnellschnittdiagnostik |
| US5383472A (en) * | 1993-07-22 | 1995-01-24 | Devlin; Mark T. | Method and apparatus for handling of biopsy tissue specimen |
| US7030373B2 (en) * | 2003-12-19 | 2006-04-18 | Applera Corporation | MALDI plate construction with grid |
| CN203107166U (zh) * | 2013-03-05 | 2013-08-07 | 范连钧 | 一种肿瘤标本收集装置 |
-
2015
- 2015-03-06 BR BR102015004994-3A patent/BR102015004994B1/pt active IP Right Grant
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2016
- 2016-03-03 CA CA2975278A patent/CA2975278A1/en not_active Abandoned
- 2016-03-03 AU AU2016228972A patent/AU2016228972A1/en not_active Abandoned
- 2016-03-03 EP EP16760946.0A patent/EP3267175A4/en not_active Withdrawn
- 2016-03-03 CN CN201680013149.0A patent/CN107407620A/zh active Pending
- 2016-03-03 US US15/551,559 patent/US20180067096A1/en not_active Abandoned
- 2016-03-03 WO PCT/BR2016/050047 patent/WO2016141444A1/pt active Application Filing
- 2016-03-03 MX MX2017011211A patent/MX2017011211A/es unknown
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5020088A (en) * | 1988-03-25 | 1991-05-28 | Tobin John A | Tissue sample localizer device and method |
| US5105457A (en) * | 1990-04-19 | 1992-04-14 | Glassman Stuart L | Mammograph x-ray grid |
| GB9307215D0 (en) * | 1993-04-06 | 1993-05-26 | Cellpath Plc | Container |
| US5427742A (en) * | 1994-04-26 | 1995-06-27 | Holland; Wayne | Tissue processing cassette |
| JP2008026097A (ja) * | 2006-07-20 | 2008-02-07 | Teiji Takezaki | 包埋枠状基体籠及びそれを用いた包埋方法 |
| WO2013192607A1 (en) * | 2012-06-22 | 2013-12-27 | Leica Biosystems Nussloch Gmbh | Tissue sample container and methods |
| US20140065656A1 (en) * | 2012-09-05 | 2014-03-06 | Faxitron Bioptics, Llc | Specimen imaging device and methods for use thereof |
| CN203069434U (zh) * | 2013-02-26 | 2013-07-17 | 孙树艳 | 一种新型病理科用小组织标本包埋盒 |
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| Publication number | Publication date |
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| BR102015004994B1 (pt) | 2022-06-28 |
| BR102015004994A2 (pt) | 2016-09-06 |
| EP3267175A1 (en) | 2018-01-10 |
| WO2016141444A1 (pt) | 2016-09-15 |
| US20180067096A1 (en) | 2018-03-08 |
| EP3267175A4 (en) | 2018-11-07 |
| MX2017011211A (es) | 2018-08-09 |
| CA2975278A1 (en) | 2016-09-15 |
| AU2016228972A1 (en) | 2017-08-24 |
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