CN102159255A - 多孔生物可吸收的植入物 - Google Patents
多孔生物可吸收的植入物 Download PDFInfo
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- CN102159255A CN102159255A CN2009801354617A CN200980135461A CN102159255A CN 102159255 A CN102159255 A CN 102159255A CN 2009801354617 A CN2009801354617 A CN 2009801354617A CN 200980135461 A CN200980135461 A CN 200980135461A CN 102159255 A CN102159255 A CN 102159255A
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Abstract
所描述的生物可吸收植入物具有生物可吸收材料形成的多孔主体，其体内寿命为至少2周、优选至少3周，并且不超过20周、优选不超过10周。植入物具有支架结构，促进组织向内生长并最终组织替换支架结构。植入物至少在外缘具有不透射线的显影剂，并且在植入物内部有定位的多种不透射线的元素。植入物优选在内部具有三种不透射线的元素，所述元素在植入物内部形成平面。
Description
技术领域
本发明一般涉及多孔生物可吸收的植入物，其用于活组织检查或病灶切除术操作后的软组织例如乳房组织中的空腔(cavities)。体现本发明特征的植入物尤其适合支撑这些空腔，并且可以成像以促进适形三维辐射(conformal three dimensional irradiation)。
背景技术
在软组织中进行的活组织检查和其他组织切除手术经常导致凹陷和其他外形损坏，除非在组织已经被切除的空腔内放置一个假体或植入物。例如参见美国专利6,214,045、美国专利6,638,308和美国专利6,881,226(Corbitt等)。此外，在涉及癌症的组织切除操作，例如病灶切除术后，经常希望辐射空腔内层，以保证有效治疗任何可能残留的癌细胞。
虽然已经提出了很多用于填充组织切除操作，例如病灶切除术后体内的空腔(body cavities)的植入物，但是几乎没有获得重大的商业成功。
发明内容
本发明一般涉及一种用于体内的空腔的植入物，包括生物可吸收材料形成的多孔主体(porous body)，所述可吸收材料具有的体内寿命为至少两周，但是不超过20周，优选至少3周但不超过约10周。植入物具有多孔性(porosity)，或者能够形成多孔性以便在组织已经被切除的体内的空腔内形成临时的支架(scaffolding)，从而保证在植入物被显著的生物吸收之前，组织向内生长进入空腔。还为植入物提供了不透射线的显影剂，以保证至少其外缘能够成像，例如通过CT扫描，以便设计给药方案。另外，还为该植入物提供了内部定位标示物，例如在植入物内部有至少两个并且优选三个不透射线的元素(element)，以促进空腔的定位，以及提供了外部辐射源，例如线性加速器，用于对更可能含有残留癌细胞的空腔内层进行适形辐射(conformal irradiation)。外部供能的定位标示物例如RFID′s也适用。参见例如美国专利7,535,363，通过引用并入本文。
植入物的生物可吸收材料至少部分是生物可吸收的脱乙酰壳多糖或藻酸盐。本体还包括选自下述的生物可吸收材料：葡聚糖、淀粉、聚乳酸、聚羟基乙酸及其共聚物，和明胶，优选交联的明胶。不透射线的显影剂可以选自硫酸钡、碳酸钡、氯化银、碘化银、硝酸银、碳酸钙、氧化锌和不透射线的金属粉末或微粒。不透射线的显影剂是特定的形式并且优选粉末的形式，以便促进成像，尤其是植入物的外缘成像。多种放置在植入物的本体内部用于定位的标示物元素可以选自金、钛、铂、铱、钽、钨、银、铼和非磁性不锈钢。这些金属标示物被掺入进植入物以呈现线形(由两种标示物元素限定)，并且优选呈现一个平面(由三种标示物元素限定)，从而允许外部辐射源(radiation source)，例如线性加速器与空腔对准，从而进行空腔内层组织的有效辐射。
对植入物的大小和形状进行调整以适合体内的空腔，并且使空腔内层组织沿植入物贴合(conform)。虽然可以采取其他形状，但一般来说，植入物为球形或椭圆形。优选植入物在放置在空腔内后略有膨胀，例如植入物材料与位于空腔处可能存在的含水液体，例如体液和其他液体接触时(通过吸收水或者水合(hydrating))隆起，以保证空腔内层组织贴合到植入物外部。贴合的内层组织的最终形状不需要与最初植入物的形状相同，但是内层组织贴合的形状应当简化，使其易于剂量测定并且简化辐射形式。病灶切除术操作后的体内的空腔，例如在女性乳房内，最大尺寸可以从约0.5到约8cm，一般约3到约6cm，因此植入物应当大约为同样的尺寸，并且优选略大，以保证组织贴合。
植入物为多孔的，并且具有足够的压缩强度以支撑乳房组织。当放置到体内的空腔后，多孔性应足够促进组织向内生长。多孔性可以具有从约10到约600微米的孔径。表面孔一般为约20到约80微米，并且内部孔为约50到约200微米。植入物多孔性优选在植入物放置在体内的空腔之前形成，以便控制植入物的大小和形状。多孔性可以通过在固化本体形成后，从中去除液体或溶解可溶性材料来形成，或通过在植入物形成其形状之前，向形成植入物的混合物中掺入气体或气体发生剂而形成。优选的，另一个例子可以是在模具中冷冻脱乙酰壳多糖或藻酸盐的含水溶液以形成主体，然后冻干冷冻的主体(优选在模具外冻干)以除去冷冻的含水液体。
可以将各种治疗性或诊断性试剂加入植入物，包括例如在体内形成血栓的止血药、用于控制疼痛的麻醉剂、用于治疗残余肿瘤组织的化疗剂或促进随后的可视定位的着色剂。抗生素、抗真菌剂和抗病毒剂也可以掺入纤维标示物。
可以通过使进入酸化(1-25重量％的乙酸)的水溶液的约0.5-4％(wt.)脱乙酰壳多糖以及约0.5％-5％(wt.)粉末状的不透射线的显影剂，例如硫酸钡(促进随后对植入物的远程成像)混合来形成植入物。可以使用高达10％的脱乙酰壳多糖，但是脱乙酰壳多糖的最大溶解度为约4.5％(wt.)。在更高含量的脱乙酰壳多糖时，混合物会非常粘稠。将混合物置于呈现所希望的形状的适当的模具中，并将混合物在-1℃到-196℃冷冻大约6-12小时。将冷冻的主体从模具中取出，然后放在冻干机(大约3天)中除去水并形成多孔主体。在冻干机内冻干之后，含脱乙酰壳多糖的主体用碱或缓冲液例如氨水(5-20％wt.)中和，用去离子水将游离碱或缓冲液漂洗干净，然后干燥。多孔植入物具有乳房组织的稠度。
在使用藻酸盐的情况下，使可溶的藻酸盐例如藻酸钠以及上文讨论的不透射线的试剂混合进入含水溶液中。将藻酸盐-不透射线试剂混合物倒入适当的模具中，然后冻干或空气干燥以除去水从而形成多孔主体。将多孔主体从模具中取出，通过将多孔主体放在氯化钙溶液中，后者将藻酸钠转化为难溶的藻酸钙，从而将可溶的藻酸盐转化为难溶的藻酸盐。在混合过程中也可以将气泡掺入藻酸钠溶液以提供多孔性。
多种不透射线的标示物元素也可以在植入物形成过程中掺入其中，既可以作为溶液在模具中固化，也可以在主体形成之后。多种标示物元素应从植入物外缘向内放置。可以在多孔主体内所希望的位置形成不透射线的定位元素的通道。
脱乙酰壳多糖优选具有高纯度和高分子量。脱乙酰作用程度为约60到100％，并且优选在70到100％之间。
本发明的这些和其他优点将通过下文结合典型附图对实施方案的详细描述而更加明显。
附图说明
图1是示意性说明形成体现本发明特征的植入物的方法的流程图。
图2是将制造体现本发明特征的植入物的组分进行混合的系统剖面的示意性正视图。
图3是将混合物倒入模具形成植入物的剖面图解的示意性正视图。
图4是将干燥的多孔主体放入氯化钙溶液将可溶的藻酸盐转化为难溶的藻酸盐的剖面图解的示意性正视图。
图5是在氯化钙溶液中处理后的植入物的横截面视图。
图6是含有三种不透射线的元素的定位标示物的体现本发明特征的植入物的横截面。
图7是在植入物表面附近拍摄的体现本发明特征的植入物的剖面扫描电子显微照片(30X)。
图8是在植入物内部拍摄的体现本发明特征的植入物的剖面扫描电子显微照片(30X)。
发明详述
图1是示意性说明形成体现本发明特征的植入物的方法的流程图。具体地，在第一步10，生物可吸收材料(脱乙酰壳多糖或可溶的藻酸盐)与水以及粉末状或微粒状不透射线的显影剂例如硫酸钡混合。成孔剂例如气体也可以掺入混合物。在第二步11，将浓缩到一定程度的混合物倒入模具。模具具有成型表面，该成型表面使混合物形成所希望的形状，并在其中固化或硬化到在所形成的形状中自承的程度。在所阐述的例子中，形状为球形。在第三步12，将形成的主体从模具中取出，并在步骤13中将水从主体中去除，优选通过冻干或空气干燥，形成多孔主体。在第四步14a，如果多孔主体由脱乙酰壳多糖形成，主体内残留的酸用适当的碱例如氨水中和，然后漂洗并干燥。在第四步14b，如果多孔主体由藻酸盐形成，多孔主体浸入氯化钙溶液，其中至少部分藻酸钠转化为难溶的藻酸钙，然后漂洗并干燥。可以将定位标示物通过插管插入多孔主体或者在多孔主体内提供一条或多条通道，从而可以将定位标示物挤入多孔主体内所希望的位置。
图2说明向适当容器21中的水20的本体中加入生物可吸收的脱乙酰壳多糖或藻酸钠和硫酸钡粉末。通过转动杆23所附带的螺旋桨22使水20与混合元素混合。可以将气泡搅入团块(mass)，或者可以将其他成孔剂引入水20的本体。另外，也可以加入水溶性材料，这样它们随后可以在主体已经干燥后溶解掉。如图3所示，将水或胶的本体倒入球形模具24，其具有上半部25和下半部26，通过托架27和28连接在一起。主体形成后，去除水，例如通过冻干，以便形成多孔的球体29。如果主体含有脱乙酰壳多糖，则用碱处理主体以中和残留的酸。如果主体内含有藻酸钠，然后如图4所示，将多孔球体29引入容器31中的氯化钙水溶液30，其中至少部分藻酸钠被转换成藻酸钙，后者迅速沉淀。图5中进行示意性说明了最终植入物32的横截面。
图6是植入物33的横截面，其具有三种可成像的不透射线的元素34(例如，金颗粒)，其位于植入物的内部，并且从外表面向内间隔。三种不透射线的元素(例如可成像的金颗粒)显示为等边三角形的顶点，其可用作患者乳房和线性加速器之间相对位置的导向装置，从而对患者乳房内病灶切除术后空腔周围组织提供有效的辐射。最低限度地，应存在两种不透射线的元素以限定直线，并且优选三种以限定平面。然而，可以存在更多，但是它们应当在同一平面上。植入物内不透射线的显影剂(硫酸钡)能够使植入物的外缘在CT扫描中被成像，并且这样有助于确定用于线性加速器的适当的辐射剂量方案，以保证对病灶切除术后空腔内层任何残留的癌细胞进行有效的治疗。
实施例I
制备含4重量％脱乙酰壳多糖和2重量％硫酸钡的酸性水溶液(12.5％的乙酸)。溶液置于球形模具中，然后在-30℃下在模具中冷冻16小时。冷冻的主体从模具中取出，并冻干3天，以除去水。冻干的主体在10％的氨水中中和一小时，然后用去离子水将氨水漂洗干净。主体在真空干燥16小时。主体具有接近乳房组织的海绵状稠度，并且具有足够的挤压强度以支撑病灶切除术后空腔周围的乳房组织。其含有67％脱乙酰壳多糖和33％硫酸钡。图6显示了表面多孔性的SEM显微照片(30X)，并且图7显示了中心多孔性的SEM显微照片(30X)。植入物具有接近乳房组织的海绵状稠度。可以通过增加脱乙酰壳多糖含量使植入物更坚硬。
实施例II
将一定量藻酸盐(0.5到约4％(wt.))溶于水，形成糊状、粘稠液体或胶体，将空气或其他生物相容的气体引入混合物。将混合物置于具有所希望植入物形状的模具中，然后冻干或空气干燥成所希望的形状。将所形成的藻酸盐的植入物结构引入氯化钙溶液(0.5到约4％(wt.))，在其中至少部分藻酸钠转化为藻酸钙，后者沉淀。将沉淀的多孔结构的植入物引入组织已经被切除的体内的空腔中。植入物在该部位保留足够时间段，以便作为支架促进组织在体内的空腔内向内生长。淀粉，例如细分颗粒形式的玉米淀粉，可以掺入藻酸钠-水混合物，这样当藻酸钙形成时，它们沉淀在淀粉颗粒附近，从而使藻酸钠向藻酸钙转换过程中的皱缩最小化。在体液存在的条件下，淀粉在体内的空腔内迅速降解。植入物表面上的藻酸盐降解，以打开掺入的淀粉颗粒使其降解，从而提供演变的多孔性。淀粉与藻酸盐的重量比可以从约15∶1到约1∶1。
实施例III
本实施例类似于实施例II，除了30克盐(氯化钠)颗粒混合约30ml的3％(wt.)的藻酸钠水溶液。将溶液置于球形模具内，然后冷冻4小时。冷冻的植入物从模具内取出，并置于2％(wt.)氯化钙溶液中，形成藻酸钙凝胶，并溶解至少一部分掺入的盐颗粒以形成多孔结构。植入物具有接近乳房组织的海绵状稠度。可以通过增加溶液中藻酸钠含量，降低盐含量或降低盐颗粒大小制造更坚硬的植入物。
虽然在植入物方面，尤其是病灶切除术后使用的乳房植入物方面，本说明书已经说明并描述了一种或多种特定的发明形式，但是本领域技术人员清楚，具有本发明特征的植入物可以用于各种部位和各种应用，其中组织已经切除。另外，在不偏离本发明精神和范围的前提下，可以进行各种修饰。相应的，不意味着本发明限制在所说明的具体实施方案中。因此，希望本发明通过所附权利要求，在现有技术允许并且如果需要，考虑本说明书的条件下尽可能宽的范围内加以确定。并且，本领域技术人员将认可一个实施方案中显示的特征可以在另一个实施方案中利用。
术语例如″元素″、″成员″、″装置″、″切面″、″部分″、″步骤″、″方式″以及类似意思，在用于下列权利要求时，不应理解为援引联邦法典第35章第§112(6)的规定，除非下列权利要求清楚地使用术语″方式″，然后是没有具体结构的特定功能，或者清楚地使用术语″步骤″，然后是没有具体行动的特定功能。所有上文中提到的专利和专利申请均通过引用，整体并入本文。
Claims (16)
1.一种用于体内的空腔的植入物，包括生物可吸收材料形成的主体、促进所述植入物外缘成像的不透射线的显影剂以及内部定位标示物，所述主体具有足以保证在所述植入物被显著的生物吸收之前组织向内生长的多孔性，所述标示物从所述植入物外缘向内间隔以促进植入物和辐射源之间相对定位。
2.权利要求1的植入物，其中所述定位标示物含有多种不透射线的元素。
3.权利要求1的植入物，其中所述生物可吸收材料为脱乙酰壳多糖或藻酸盐。
4.权利要求3的植入物，其中所述生物可吸收材料的体内寿命为至少2周，但不超过约20周。
5.权利要求3的植入物，其中所述生物可吸收材料包括选自下述的材料：聚乳酸、聚乙醇酸、聚乳酸和聚乙醇酸共聚物、交联明胶和一种或多种选自葡聚糖和淀粉的多糖。
6.权利要求1的植入物，其中所述不透射线的显影剂选自硫酸钡、碳酸钡、氯化银、碘化银、硝酸银、碳酸钙和氧化锌。
7.权利要求1的植入物，其中所述多种不透射线的元素包括选自下述的金属材料：钛、铂、金、铱、钽、钨、银、铼和非磁性不锈钢组成的组。
8.权利要求1的植入物，所述植入物具有在约0.5和约8cm之间的最大横截面尺寸。
9.权利要求1的植入物，所述植入物具有在约2和约6cm之间的最大横截面尺寸。
10.权利要求1的植入物，其中所述多种不透射线的元素在植入物内部形成平面。
11.权利要求1的植入物，其中所述植入物具有三种不透射线的元素，所述元素位于等边三角形的顶点。
12.权利要求1的植入物，其中所述孔径范围从约10到约600微米。
13.权利要求1的植入物，其中外缘孔径范围从约20到约80微米。
14.权利要求1的植入物，其中所述植入物内部孔径为从约50到约200微米。
15.权利要求3的植入物，其中所述生物可吸收材料为藻酸钙。
16.权利要求1的植入物，其中所述定位标示物为可外部供能的RFID。
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| CN201610250071.6A Active CN105920676B (zh) | 2008-09-23 | 2009-09-22 | 多孔生物可吸收的植入物 |
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| US (4) | US9327061B2 (zh) |
| EP (2) | EP2886135B1 (zh) |
| JP (3) | JP5710483B2 (zh) |
| CN (2) | CN105920676B (zh) |
| AU (1) | AU2009300354B2 (zh) |
| BR (1) | BRPI0919822B1 (zh) |
| CA (1) | CA2734239C (zh) |
| ES (1) | ES2534550T3 (zh) |
| MX (1) | MX2011003137A (zh) |
| WO (1) | WO2010039184A2 (zh) |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108135928A (zh) * | 2015-09-07 | 2018-06-08 | 持田制药株式会社 | 藻酸冻结干燥制剂 |
| US10966929B2 (en) | 2015-09-07 | 2021-04-06 | Mochida Pharmaceutical Co., Ltd. | Freeze-dried alginic acid preparation |
| CN113274360A (zh) * | 2015-09-07 | 2021-08-20 | 持田制药株式会社 | 藻酸冻结干燥制剂 |
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| US9327061B2 (en) | 2016-05-03 |
| JP2012503498A (ja) | 2012-02-09 |
| JP2015144834A (ja) | 2015-08-13 |
| CN105920676A (zh) | 2016-09-07 |
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| US20210023278A1 (en) | 2021-01-28 |
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