CN102119046A - 利用植入物瞄准外部波束放射的系统 - Google Patents
利用植入物瞄准外部波束放射的系统 Download PDFInfo
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Abstract
一种部分乳腺放射的新颖方法,该方法利用能够为立体定向放射治疗提供稳定且改进的靶的乳房植入物。
Description
背景技术
目前乳腺癌的放射主要包括全乳房放射,其对乳房的全部区域给予放射治疗。这必然影响周围结构,例如但不限于心脏、肺、食管、胸壁、肋骨以及乳房附近的其它结构。一种瞄准癌变乳腺区域的部分乳房放射的新概念正变得愈发流行。迄今为止的研究表明它和全乳房放射一样有效并且减轻了对周围器官的损伤。部分乳房放射当前通过临时植入的气囊导管进行递送,例如但不限于通过MAMMOSITE或CONTURA进行递送。这个过程涉及将放射性粒源或靶在导管底部放置一较短时间段,3到5天以上。遗憾的是,这种利用导管和放射性粒源的方法有很多缺点。在较短时间段内以通过导管或其它外科手段植入放射性粒源的形式利用集中剂量的放射会造成诸多副作用,例如脂肪坏死、血清肿、血肿、感染和不希望的外观效果。当实施乳房肿瘤切除术时,临时气囊导管被放入以使得导管从乳房中伸出。这就形成了一个向腔内的开口,由此增加了感染机会。此外,这种方法要求内科医生需要在该临时气囊可被移除以及Mammosit、Contura或其它外部导管可以被植入作为部分乳房放射疗法的准备之前等待病理学报告表明样本边缘并无癌变(还有淋巴腺上没有癌变)。这个程序序列最好在乳房肿瘤切除术后尽快实施。导管法的另一缺点是需要从乳房肿瘤切除术腔内抽出空气。乳房肿瘤切除术腔内的空气在经受放射疗法时会在腔内形成“热点”或高热环境,由此造成烧伤或其他不良副作用。因此,希望能够抽出或去除空气,最通常地是用注射器和针。不幸地是,当前方法的导管可能会在抽取期间被针刺穿,从而在导管随后的使用和治疗有效性造成问题。使用本发明的方法可以解决这些问题。本发明使用通过多方向立体定向放射源(例如但不限于CYBERKNIFE、BRAIN LAB和其他外部波束源)递送的外部波束放射。然而,外部波束放射需要充分可辨别的靶。当前,外部波束放射用于固体器官,例如含肿瘤的肝上或含肿瘤的胰头,由此将金粒源植入这些结构内并且作为聚集外部立体定向波束的向导。这些器官的固体组织为充当外部波束源的靶的粒源放置提供稳定的、非移位环境。在乳房组织中使用导管在现有技术中是必须的,这是因为乳房中大量脂肪组织的存在妨碍了放置小粒源或靶的稳定环境。在脂肪组织中,小粒源或靶可能会从预期的靶点移开,由此致使治疗无效。与其它提到过的器官不同,乳房是主要由脂肪组织构成的外部结构。因此,必需有一种在乳房的脂肪组织中稳定粒源或其它靶源的手段,使得粒源或其它靶源可以作为一种新的部分乳腺放射方法中的靶。本发明解决了这个问题。仍然是一种外部结构,但乳房同样能够为在立体定向放射机瞄准时比内部器官更加牢靠地固定,并且因此完全可以通过仔细瞄准内部植入物或标记物而使用部分照射。
申请人已授权美国专利No.6,214,045公开了一种依尺寸制造以代替切除组织并且允许纤维组织向内增长以代替植入物的可再吸收材料的乳房植入物。植入物可以是有弹性的、可压缩的和可膨胀的,还可进一步包含诊断物质。美国专利No.6,214,045的说明书通过引用结合于此。某些诊断物质在’045专利中被标识为“用于标识区域的不透x射线或金属材料”。’045专利中描述的诸多植入物实施例可以作为不透射线靶来用作立体定向放射源的合适靶。例如但不限于胶原和其它适当致密生物相容材料的可生物降解材料可被适当配置为不透射线的。作为替换,植入物可由两种或更多不同材料构成或者包含大量空气,空气也可辅助合适立体定向放射源的获得和瞄准。植入物可被做成球形以使乳房肿瘤切除腔以更均一的方式保持张开,尽管由于可以允许活检程序形成的乳房肿瘤切除腔部分塌陷并符合植入物的尺寸或形状而并非是必须的。因此,植入物形状可引导外部波束源,以便允许在植入物的一侧或另一侧或者在使用球面植入物时均一圆周地照射腔中更特异的区域。特别是在与先前公开的导管疗法相比时,在必需构建非球形乳房肿瘤切除腔以获取癌症去除后的期望边缘的情况下,使用各种形状的植入物的能力优于球形形状的导管。植入物本身可以用作不透射线靶,或者多少可以在植入物中心部分添加了微小金属标记物,例如但不限于金粒源或钛粒源以进一步辅助作为外部波束的向导。为与期望的治疗要求和程序相一致,可在放置在乳房肿瘤切除腔内的单个植入物或一个以上的植入物内使用一个以上的标记。可以在位于乳房肿瘤切除腔内的单个植入物或一个以上的植入物内包含不同的标记物材料。任何金属材料、适当的已消毒或其它相对致密的生物相容材料可用作植入物内的标记物。在使用外部波束放射的情况下,其有利于完成局部近距离放射疗法并且可以在变化的时间段上配置波束以消除当前部分乳房放射法(气囊MammaSite或Contura)相关的并发症。’045专利中所描述的植入物的使用解决了医疗产业当前已知的诸多难题,例如但不限于外观畸形、血清肿、感染等,同时提供成功瞄准的放射疗法所必需的稳定靶。045植入物被配置为保持腔的张开并且支撑周围组织。这在放射疗法中尤为重要,因为新组织的生长会因放射疗法的存在而被抑制。因此,该方法和植入物的使用能够让乳房肿瘤切除部位在整个放射疗法中保持外形,并在随后在放射疗法结束后为新组织的再生和内生长提供时间。一旦外部波束放射完成,植入物会在一段时间内生物降解,允许病人自身组织的内生长,并且因此降低覆盖的皮肤或乳房的不期望的外观变化的风险。植入物也可能已经加入了最小化出血的止血剂、其它金属标记物、肿瘤药剂、抗生素等等。
使用针对瞄准的部分乳腺放射治疗的植入物的另一优点是可以在乳房肿瘤切除术时将可生物降解植入物插入乳腺且放射疗法可被推后,而不会出现保持瞄准装置、治疗或对病人出现的并发症。使用导管法,向外伸出的导管和其先前提及的组织需要即时放射疗法治疗以尽可能减小潜在的例如感染的并发症和病人的不适感。由于外科伤口是新形成且尚未愈合,因此即时放射疗法并不总是优选的。放射的使用进一步延缓了愈合并且由于愈合不良还会导致血清肿形成、感染和外观缺陷。本发明的方法利用植入物允许植入物被放置在乳房肿瘤切除术腔内,并且创口被外科缝合。病人可以保持正常的生活方式,并且可按照具体情况合适安排放射疗法。病人可以接收化疗,并且能够延迟放射疗法长达约120天而不降低放射的治疗效果。植入物会在一段时间内些许退化,同时乳房愈合从而允许乳房肿瘤切除术腔在植入物上压缩或在植入物周围结疤,收缩腔并稳定靶以供后续放射。后续的放射治疗可在乳房肿瘤切除术后的若干天或几周后进行。如果需要,放射治疗在可生物降解的植入物的寿命内或者在标记的情况下,在此后的任何时间内可以是不连续的,并根据需要重新设立。这实现了对血肿或血清肿的预防,在得到更好的外观效果的同时为后续治疗和诊断保持了稳定靶。
附图说明
图1示出了置于乳房肿瘤切除术腔内用作放射疗法发射靶的植入物的一个实施例。
图2示出了置于乳房肿瘤切除术腔内并包含内部标记物的用作放射疗法发射靶的植入物的可选实施例。
图3示出了置于乳房肿瘤切除术腔内并接收放射疗法发射的植入物的一个示例。
图4示出了包含内部标记物的作为放射疗法发射靶的植入物的可选实施例。
图5A和5B示出了各种形状并被配置为置于乳腺乳房肿瘤切除术腔内的植入物。
图6示出了在萎缩的乳腺乳房肿瘤切除术腔内的被部分再吸收的植入物。
图7示出了在萎缩的乳腺乳房肿瘤切除术腔内的包含金属标记物的被部分再吸收的植入物。
具体实施方式
在图1中,大体呈球形的植入物(100)由可生物降解材料组成,并在活组织检查或其它外科程序之后被置于乳房肿瘤切除腔(110)内。植入物可由例如可生物降解泡沫、海绵、胶体、液体或其它生物相容物质的材料构成。材料被以可支撑周围乳房组织的方式塑造,由此通过防止乳腺乳房肿瘤切除术腔塌陷来帮助保持乳房外观。植入物还起到为外部波束立体定向部分乳房放射疗法的不透射线靶的作用。植入物能够以不同的孔隙尺寸构建,从而允许例如更多的空气包含在植入物内,由此使得得入物更加不透射线同时防止会对放射疗法创建不适宜条件的乳腺腔内气穴的聚集。然而,植入物不必是乳房肿瘤切除腔的精确尺寸。乳房组织将围绕植入物塌陷,保持腔的张开并且到植入物中心相对等距。植入物具有足够大的尺寸和固体一致性以允许立体定向放射源被引导至作为靶的植入物,从而以放射治疗学家确定的精确配置将放射治疗递送到乳房肿瘤切除腔的四周边沿。
在图2中,图1的植入物(100)还包含金粒源、金属粒源、钛夹或其它适当的致密植入物材料(120)以帮助立体定向放射源成功瞄准植入物区域。因为不同病人的边沿不同,所以植入物材料的使用可以用作编程立体定向放射单元的向导。靶材料可位于植入物中央或位于植入物的周边。如果需要,可以同时使用一个或多个植入物材料以顺应制定的放射疗法对病人乳腺癌的治疗。由于靶材料可以或者不可以生物降解,如果需要,植入物材料可以保持对延长的放射治疗可用。可生物降解材料可以具有不同的吸收率。
在图3中,多方向(立体定向)放射疗法(160)的一个示例瞄准乳房肿瘤切除腔(110)内的乳房植入物(100),部分照射在乳房肿瘤切除腔(110)周围的瞄准边沿(170)内的乳房。
在图4中,多方向(立体定向)放射疗法(160)的一个示例瞄准包含在乳房肿瘤切除腔(110)内的内部标记物(120)的乳腺植入物(100),部分照射在乳房肿瘤切除腔(110)周围的瞄准边沿(170)内的乳房。
在图5A和图5B中,乳房肿瘤切除腔(110)内的植入物(100)被配置为符合创建足以切除癌变组织的充分边沿或者根据外科程序的良好医学实践所需的切除的乳房肿瘤切除腔。使植入物顺应腔的能力允许为后续的放射治疗保留合适的边沿,并支撑周围的乳房组织而不变形。
在图6中,植入物(100)随时间流逝被部分再吸收。与现有技术中的导管不同,该植入物可在植入后的几周或几个月内用作活检部位靶,由此允许愈合、化疗或在放射疗法中其它的延迟需要。随着植入物吸收,包含乳房肿瘤切除腔的周围乳房组织塌陷或生长,将植入物保持在适当的位置并且与乳房组织的几何形状处于静态关系。
在图7中,正在吸收的植入物(100)还包含一个或多个标记物(120)以帮助瞄准。同样地,植入物和标记物允许治疗的内科医生推迟基于愈合、化疗或其它有利延迟原因的放射治疗。
Claims (9)
1.一种部分乳腺放射系统,包括以下步骤:
用于将由生物相容且可生物降解的材料构成的大体上不透射线的植入物放入乳房腔内的装置,所述植入物支撑乳房腔周围的组织;以及
使放射波束瞄准所述植入物周围的乳房组织以使放射波束不实质照射整个乳房的装置。
2.权利要求1的系统,还包括经由立体定向放射机使治疗有效用量的放射瞄准所述植入物周围的所述乳房组织的装置。
3.权利要求2的系统,还包括经由立体定向放射机在单次治疗中使多份治疗有效用量的放射瞄准所述植入物周围的所述乳房组织的装置。
4.权利要求2的系统,还包括经由立体定向放射机在单次治疗中多次使治疗有效用量的放射瞄准所述植入物周围的所述乳房组织的装置。
5.权利要求1的系统,还包括经由多方向放射疗法使治疗有效用量的放射瞄准所述植入物周围的所述乳房组织的装置。
6.权利要求1的系统,还包括经由图像引导放射疗法使治疗有效用量的放射瞄准所述植入物周围的所述乳房组织的装置。
7.权利要求1的系统,还包括经由3-D适形放射疗法使治疗有效用量的放射瞄准所述植入物周围的所述乳房组织的装置。
8.权利要求1的系统,还包括经由密度调制放射疗法使治疗有效用量的放射瞄准所述植入物周围的所述乳房组织的装置。
9.权利要求1的系统,还包括在植入物放置后的任何时间从乳房肿瘤切除腔中吸出空气的装置。
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PCT/US2009/002551 WO2009134340A1 (en) | 2008-04-28 | 2009-04-24 | System for utilizing an implant for targeting external beam radiation |
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CN102119046A true CN102119046A (zh) | 2011-07-06 |
CN102119046B CN102119046B (zh) | 2016-10-26 |
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US (5) | US8288745B2 (zh) |
EP (1) | EP2271404A1 (zh) |
JP (1) | JP2011518640A (zh) |
KR (2) | KR20110009175A (zh) |
CN (1) | CN102119046B (zh) |
AU (1) | AU2009241851B2 (zh) |
BR (1) | BRPI0911904B8 (zh) |
CA (1) | CA2722747C (zh) |
WO (1) | WO2009134340A1 (zh) |
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2009
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- 2009-04-24 CA CA2722747A patent/CA2722747C/en active Active
- 2009-04-24 JP JP2011507420A patent/JP2011518640A/ja active Pending
- 2009-04-24 WO PCT/US2009/002551 patent/WO2009134340A1/en active Application Filing
- 2009-04-24 AU AU2009241851A patent/AU2009241851B2/en active Active
- 2009-04-24 CN CN200980121745.0A patent/CN102119046B/zh active Active
- 2009-04-24 KR KR1020107026372A patent/KR20110009175A/ko not_active Application Discontinuation
- 2009-04-24 KR KR1020167010729A patent/KR20160050093A/ko not_active Application Discontinuation
- 2009-04-24 EP EP09739143A patent/EP2271404A1/en not_active Ceased
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2012
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CN105407955B (zh) * | 2013-03-15 | 2018-11-13 | 波士顿科学公司 | 输送药物的装置和方法 |
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AU2009241851B2 (en) | 2014-04-03 |
US20140156003A1 (en) | 2014-06-05 |
CN102119046B (zh) | 2016-10-26 |
CA2722747C (en) | 2020-07-07 |
US20080281388A1 (en) | 2008-11-13 |
AU2009241851A1 (en) | 2009-11-05 |
WO2009134340A1 (en) | 2009-11-05 |
KR20160050093A (ko) | 2016-05-10 |
US20120302818A1 (en) | 2012-11-29 |
BRPI0911904B1 (pt) | 2020-12-08 |
US8541764B2 (en) | 2013-09-24 |
BRPI0911904A2 (pt) | 2019-03-06 |
US20140012376A1 (en) | 2014-01-09 |
JP2011518640A (ja) | 2011-06-30 |
BRPI0911904B8 (pt) | 2021-06-22 |
CA2722747A1 (en) | 2009-11-05 |
US8680498B2 (en) | 2014-03-25 |
US8288745B2 (en) | 2012-10-16 |
KR20110009175A (ko) | 2011-01-27 |
US20160250018A1 (en) | 2016-09-01 |
EP2271404A1 (en) | 2011-01-12 |
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