CN108136077A - 粘弹性组合物 - Google Patents

粘弹性组合物 Download PDF

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Publication number
CN108136077A
CN108136077A CN201680056961.1A CN201680056961A CN108136077A CN 108136077 A CN108136077 A CN 108136077A CN 201680056961 A CN201680056961 A CN 201680056961A CN 108136077 A CN108136077 A CN 108136077A
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CN
China
Prior art keywords
endoscope
visual field
viscoelastic composition
viscoelastic
composition
Prior art date
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Application number
CN201680056961.1A
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English (en)
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CN108136077B (zh
Inventor
矢野智则
大畑淳
后藤敏裕
平木勇次
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Otsuka Pharmaceutical Co Ltd
Jichi Medical University
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Otsuka Pharmaceutical Co Ltd
Jichi Medical University
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Priority to CN202211014759.6A priority Critical patent/CN115413997A/zh
Publication of CN108136077A publication Critical patent/CN108136077A/zh
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Publication of CN108136077B publication Critical patent/CN108136077B/zh
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  • Health & Medical Sciences (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Optics & Photonics (AREA)
  • Pathology (AREA)
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  • Biomedical Technology (AREA)
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Abstract

本发明的目的在于，提供一种适于在管内部积存有视野不好的深色液体而遮住内窥镜的视野时推开该液体来确保内窥镜的视野的用途、且操作性优异的粘弹性组合物以及使用了该粘弹性组合物的确保内窥镜的视野的方法，内窥镜的视野确保用的粘弹性组合物含有显示出粘弹性特性的物质和水，优选的是硬度为550N/m2以下，粘度(25℃)为200～2000mPa·s，损耗角正切为0.6以下，进一步优选的是电导率为250μS/cm以下，确保内窥镜的视野的方法包括将该粘弹性组合物从内窥镜的手边部通过通道送入内窥镜的前端部。

Description

粘弹性组合物
技术领域
本发明涉及一种适于确保内窥镜的视野的用途的粘弹性组合物以及使用了该粘弹性组合物的确保内窥镜的视野的方法。更详细而言，涉及一种适于在管(canal)内部积存有视野不好的深色液体而遮住内窥镜的视野时推开该液体来确保内窥镜的视野的用途、且操作性优异的粘弹性组合物以及使用了该粘弹性组合物的确保内窥镜的视野的方法。
背景技术
内窥镜能够观察消化道、胆管等细管的内部。但是，当管的内部积存有血液、肠液、胆汁等遮光之类的深色液体、食物残渣、***物等半固态物时，会遮住内窥镜的视野，无法充分地观察管内部的状态。在这样的情况下，以往，通过在管内部送水或送气来确保内窥镜视野。送水是指，将自来水等水注入管内来冲走管内部的液体、半固态物的方法。该方法通过去除管内部的液体、半固态物会暂时地确保视野，但是，所去除的液体、半固态物与自来水等混在一起，悬浮的不透明液体会扩散至管内，往往依然难以确保视野。另外，送气是指，向管内部送入空气来去除管内部的液体、半固态物的方法。该方法也通过去除管内部的液体、半固态物会暂时地确保视野，但是，在存在出血部位的情况下难以去除血液，无法确保视野，因此，存在出血部位的确定、止血治疗的操作伴有困难的问题。由此，迫切需要开发一种操作性优异、并且确保内窥镜的视野的方法。
再者，专利文献1公开了一种将由交联后的聚合物形成的水凝胶注入尿道、直肠来治疗尿失禁、***失禁、或者膀胱输尿管返流等的方法。
专利文献2公开了一种具有多糖类以及合成聚合物和交联剂的水凝胶组合物。该水凝胶组合物利用缓冲液进行交联固化而变成粘着性水凝胶。
专利文献3公开了一种通过填充生理盐水或者乳酸林格氏液之类的生理流体来使子宮等体腔膨胀从而对该体腔内进行治疗的方法。
现有技术文献
专利文献
专利文献1：日本特表2007-506463号公报
专利文献2：日本特表2013-510175号公报
专利文献3：日本特表2000-513970号公报
发明内容
发明所要解决的问题
本发明的问题在于，提供一种适于在管内部积存有视野不好的深色液体而遮住内窥镜的视野时推开该液体来确保内窥镜的视野的用途、且操作性优异的粘弹性组合物以及使用了该粘弹性组合物的确保内窥镜的视野的方法。另外，理想的是提供一种能够辅助简便的止血治疗的该粘弹性组合物。
用于解决问题的方案
本发明人等为了解决上述问题而进行了深入研究，结果发现了如下事实，从而完成了下述本发明：使用具有粘性以及弹性的粘弹性组合物是有用的，特别是，通过规定硬度、粘度、损耗角正切的物性值，内窥镜的操作性优异，并且能够确保良好的视野。进而，发现了：通过调整本发明的粘弹性组合物的电导率，能够确保良好的视野并且能够辅助简便的止血治疗。
〔1〕一种内窥镜的视野确保用的粘弹性组合物，其含有增粘性物质和水。
〔2〕根据〔1〕所述的粘弹性组合物，其硬度为550N/m2以下，25℃时的粘度为200～2000mPa·s，损耗角正切为0.6以下。
〔3〕根据〔2〕所述的粘弹性组合物，进一步，其电导率为250μS/cm以下。
〔4〕一种确保内窥镜的视野的方法，其包括：将所述〔1〕～〔3〕中任一项所述的粘弹性组合物从内窥镜的手边部通过通道送入内窥镜的前端部。
〔5〕根据〔4〕所述的方法，其中，内窥镜为医疗用内窥镜。
发明效果
本发明的粘弹性组合物具有粘性以及弹性的性质，通过其粘弹性能够物理推开血液、肠液、胆汁等液体、食物残渣、***物等半固态物。另外，就本粘弹性而言，由于难以与先前的液体、半固态物混在一起，因此不会悬浮，并且由于具有适当的稠度(consistency)，因此不会扩散，能够确保良好的视野。另外，本发明的粘弹性组合物通过不含有或者最小限度地含有带电荷的物质来降低电导率，由此，能够在粘弹性组合物的存在下确保视野并且能够辅助利用电切或者电凝等进行的止血措施。
附图说明
图1是表示医疗用内窥镜的手边部的照片的图。
图2A是表示出血后的消化道内的状态的概念图。
图2B是表示向出血后的消化道内送入水时的状态的概念图。
图3A是表示出血后的消化道内的状态的概念图。
图3B是表示向出血后的消化道内送入本发明的粘弹性组合物时的状态的概念图。
图4A是对将粘弹性组合物用于内窥镜时的从视野确保的观点出发的评价方法进行说明的图。
图4B是对将粘弹性组合物用于内窥镜时的从视野确保的观点出发的评价方法进行说明的图。
图5A是对将粘弹性组合物用于内窥镜时的从视野确保的观点出发的评价方法进行说明的图。
图5B是对将粘弹性组合物用于内窥镜时的从视野确保的观点出发的评价方法进行说明的图。
图6是表示粘弹性组合物的粘度以及损耗角正切与用于内窥镜时的视野确保的合格与否的关系的图表。
图7是表示粘弹性组合物的粘度以及硬度与用于内窥镜时的操作性的适合与否的关系的图表。
图8是表示粘弹性组合物的硬度以及损耗角正切与用于内窥镜时的视野确保以及操作性的合格与否/适合与否的关系的图表。
图9是表示从内窥镜的钳子注入水时所得的摄像机图像的一个例子的图。
图10是表示从内窥镜的钳子注入粘弹性组合物时所得的摄像机图像的一个例子的图。
图11是表示模仿了利用内窥镜的治疗的使用了高频电流的热凝固处理的结果的图。
图12是表示模仿了利用内窥镜的治疗的使用了高频电流的热凝固处理的结果的图。
图13是表示模仿了利用内窥镜的治疗的使用了高频电流的热凝固处理的结果的图。
图14是表示模仿了利用内窥镜的治疗的使用了高频电流的热凝固处理的结果的图。
图15是表示模仿了利用内窥镜的治疗的使用了高频电流的热凝固处理的结果的图。
图16是表示模仿了利用内窥镜的治疗的使用了高频电流的热凝固处理的结果的图。
图17是表示模仿了利用内窥镜的治疗的使用了高频电流的热凝固处理的结果的图。
具体实施方式
本发明的粘弹性组合物含有增粘性物质(thickening substance)和水。
本发明的粘弹性组合物通过组合一种或两种以上的在分散于水时具有提高粘度的作用的增粘性物质来制备。作为这样的增粘性物质，例如可列举出：甲醇、乙醇、2‐丙醇、1，4-丁二醇、1，3-丁二醇、丙二醇、儿茶酸甘油酯(Glycerin catechin)、葡萄糖、果糖、半乳糖、蔗糖、乳糖、麦芽糖、海藻糖、木糖醇、山梨糖醇、甘露醇、氨基葡萄糖、氨基半乳糖等醇类；短梗霉(Aureobasidium)培养液、亚麻籽胶、***树胶、***半乳聚糖、海藻酸及其盐类、海藻酸丙二醇酯、威兰胶、肉桂胶(Cassia gum)、印度树胶(Ghatti gum)、可得然胶(Curdlan)、角叉菜胶(Carrageenan)、刺梧桐胶(Karaya Gum)、黄原胶、瓜尔豆胶、瓜尔豆胶酶解物、车前籽胶(Psyllium Seed Gum)、沙蒿籽胶(Artemisia sphaerocephala seedgum)、洁冷胶、琥珀酰聚糖、罗望子胶、他拉胶(Tara gum)、葡聚糖、黄蓍胶(Tragacanthgum)、红藻胶、海萝胶(Funoran)、普鲁兰多糖、果胶、大拟茎点霉属胶(MacrophomopsisGum)、中性树胶(Rhamsan Gum)、果聚糖、刺槐豆胶、丙烯酸淀粉、乙酰化己二酸交联淀粉、乙酰化氧化淀粉、乙酰化磷酸交联淀粉、辛烯基琥珀酸淀粉钠、羧甲基纤维素及其盐类、羧甲基乙基纤维素、醋酸淀粉、氧化淀粉、羟基乙酸淀粉钠、羟丙基化磷酸交联淀粉、羟丙基纤维素、羟丙基淀粉、羟丙基甲基纤维素、羟甲基纤维素、羟乙基甲基纤维素、羟乙基纤维素、乙基纤维素、甲基纤维素、纤维素、磷酸交联淀粉、磷酸化淀粉、磷酸单酯化磷酸交联淀粉、岩藻聚糖硫酸酯(Fucoidan)、定优胶(Diutan gum)、葡甘露聚糖(Glucomannan)、透明质酸及其盐类、硫酸角质素(keratan sulfate)、肝素、硫酸软骨素、硫酸皮肤素(Dermatansulfate)、硬葡聚糖、裂褶菌多糖(schizophyllan)、秋葵提取物、木立芦荟提取物(Krantzaloe extracts)、田菁胶、琼脂糖、琼脂胶(Agaropectin)、直链淀粉(Amylose)、支链淀粉(Amylopectin)、预胶化淀粉、菊粉、Levan、Graminan、琼脂(Agar)、疏水化羟丙基甲基纤维素、羟基乙酸淀粉钠、葡聚糖、糊精、交联羧甲基纤维素钠、葡糖醛酸木聚糖(Glucuronoxylan)、***糖基木聚糖(Arabinoxylan)等多糖类；明胶(Gelatin)、水解明胶、胶原蛋白等蛋白质；聚谷氨酸、聚赖氨酸、聚天冬氨酸等聚氨基酸；羧基乙烯基聚合物、聚丙烯酸及其盐类、聚丙烯酸部分中和物、聚乙烯醇、聚乙烯醇/聚乙二醇接枝共聚物、聚乙二醇、聚丙二醇、聚丁二醇等亲水性高分子；氯化钙、氢氧化铝、氯化镁、硫酸铜等金属盐等。
本发明的粘弹性组合物所使用的水并不特别限制，但优选软水、纯水、去离子水、蒸馏水等或生理盐水、林格氏液、醋酸林格氏液等生理性水溶液。
本发明的粘弹性组合物可以含有保存剂(preservative)、防腐剂(antisepticagent)等添加剂。
本发明的问题在于，提供一种操作性优异、且能够确保良好的视野的粘弹性组合物，理想的是提供一种能够辅助简便的止血治疗的粘弹性组合物，结果认为：在这些问题中，内窥镜的视野被遮住的主要原因是由于：1)血液、肠液、胆汁等液体、食物残渣、***物等半固态物积存在管腔内；2)血液、肠液、胆汁等液体、食物残渣、***物等半固态物与水混在一起会损害透明性；3)血液、肠液、胆汁等液体、食物残渣、***物等半固态物因送水而流动、扩散。为了良好地确保视野，通过将具有与血液、肠液、胆汁等液体、***物等半固态物不同的粘弹性的透明组合物注入管腔内，能够通过物理地推开、去除这些物质来确保空间，并且，难以与血液、肠液、胆汁等液体、***物等半固态物混在一起，能够抑制液体的流动、扩散。另外，操作性优异的问题是指，能够没有过度阻力地使该粘弹性组合物通过内窥镜的钳子口。能够辅助简便的止血治疗的问题是指，能够在该粘弹性组合物的存在下确认出血部位，此外还能够辅助使用了高频电流的止血治疗。
本发明的粘弹性组合物的硬度为550N/m2以下，优选为400N/m2以下，粘度(25℃)为200～2000mPa·s，优选为500～1500mPa·s，损耗角正切优选为0.6以下。
通过将硬度设为上述的范围，通过内窥镜的钳子注入时的操作性良好。另外，通过将粘度以及损耗角正切设为上述的范围，从视野确保的观点进行改善。需要说明的是，从视野确保的观点出发，粘弹性组合物可以透明。
另外，本发明的粘弹性组合物的电导率优选为250μS/cm以下，进一步优选为200μS/cm以下。
另外，通过将电导率设为上述的范围，可得到热凝固止血优异、特别是适于电切或电凝等治疗的粘弹性组合物。
本发明的粘弹性组合物通过将如上所述的增粘性物质与水混合而得到时，具体而言，可通过如下方式来得到：将两种以上的该增粘性物质组合；或者，使一种增粘性物质溶解于水等中，并通过实施加热处理来附加弹性；等等。就本发明的粘弹性组合物而言，由于其中具有气泡时会遮住视野，因此优选为实质上不具有气泡的物质。
本发明的确保内窥镜的视野的方法包括：将本发明的粘弹性组合物从内窥镜的手边部通过通道送入内窥镜的前端部。
图1是表示作为内窥镜的代表例的医疗用内窥镜的手边部的照片的图。在手边部具备：用于进行角度操作的刻度盘(dial)11；用于从光源装置传输光，并向电子内窥镜用处理器传输图像信息的镜体连接器部12；以及用于供钳子等治疗工具(treatment tool)类***并送至前端部1的钳子口15。将钳子口至前端部连通的通道、用于前端部的透镜的水清洗等的送水管、光学***等设于内窥镜软性管17中。在图1所示的医疗用内窥镜的钳子口15装配有钳子盖16。管13的一端与钳子盖16相连，管的另一端与用于装接注射器等的连接器14相连。在钳子盖16中具有阀体，管13的一端在钳子盖16内的阀体的钳子口15侧的壁面开口，在将钳子等治疗工具类***时，利用阀体，通过管送来的液体也不会流出(例如，参照日本特开2014-155677号公报)。
实施例
参考例
能够将内窥镜***例如直肠等消化道，利用内窥镜来观察消化道内部。当消化道4发生出血时，在消化道内积存有血液3，无法观察出血部位2(图2A)。此时，尝试了：向注射器中填充自来水，利用该注射器，经过管13、钳子口15、以及通道，从内窥镜前端部1的开口将水送入消化道，将所积存的血液用水冲走。但是，所积存的血液与所送入的水会混在一起并悬浮，变成浑浊水3”。当浑浊水3”积存在消化道内时，内窥镜的视野被浑浊水3”遮住，无法观察出血部位2，无法继续进行手术(图2B、图9)。
需要说明的是，根据本发明的粘弹性组合物，如图3A、图3B所示，在消化道4产生了出血部位2的情况下，通过从内窥镜的前端部送入该粘弹性组合物，推开积存在消化道内的血液3(血液3’)，能够观察出血部位2。
实施例以及比较例
在本实施例或比较例中，对内窥镜所使用的粘弹性组合物的粘弹性特性与内窥镜操作时的视野的确保以及操作性的关系进行了研究。
以下，示出粘弹性组合物的物性值的测定方法、以及将粘弹性组合物用于内窥镜时的从视野确保的观点、以及操作性的观点出发的评价方法。
(1)粘度以及损耗角正切
使用粘度/粘弹性HAAKE RS-6000(Thermo Fisher Scientific株式会社)进行测定。将粘弹性组合物载置于试样台，使用P35Ti L平行板进行测定(测定条件：温度25度、间隙1.000mm、应力1000mPa、频率0.5000Hz)，测量出测定开始30分钟后的值。
(2)硬度
使用Creep meter Model RE2-33005C(株式会社山电)进行测定。向不锈钢培养皿(外径45mm、内径41mm、外尺寸18mm、内尺寸15mm)中填充粘弹性组合物，与培养皿的高度对齐并平整样本表面。使用Plunger(株式会社山电、形状：圆板、型号：P-56、摘要：φ20×t 8)进行了测定(测定条件：存储间距0.02sec、测定失真率66.67％、测定速度10mm/sec、返回距离5.00mm、样品厚度15.00mm、接触面直径20.00mm、接触面积0.000mm2)。
(3)电导率
使用电导率计CM-41X(东亚DKK株式会社)、低电导率用CT-57101C电池进行了测定(测定条件：温度25度)。
(4)视野确保的评价方法
向Dean-Stark管中注入3mL的1％伊文思蓝溶液(色素溶液)，并***了装配有金属丝的导管(catheter tube)。在该状态下，视野会被色素溶液遮住，观察不到管顶端的金属丝(图4A、图5A)。通过导管(内径2.5～3mm、长度1.000mm)将10mL的损耗角正切、硬度以及粘度不同的粘性组合物注入色素溶液中，通过目测判定了视野确保的合格与否。在注入了某一粘性组合物A时，能够确保物理空间，并且也难以与色素溶液混合，因此，判断为该粘性组合物A发挥了所期望的粘弹性特性，作为粘弹性组合物判定为“合格”(图4B)。另一方面，在注入了与粘性组合物A不同的某一粘性组合物B时，物理空间的确保不清楚，还观察到了与色素溶液混在一起，因此，判断为该粘性组合物B未发挥出所期望的粘弹性特性，作为粘弹性组合物判定为“不合格”(图5B)。
在该视野确保的评价中所得的结果对应于例如如图9、图10所示的在视野的提供中产生差异。即，在将内窥镜***至出血部位，并注入了水时，如图9所示，由于浑浊的水，从摄像机得到的视野是不良的。另外，在将内窥镜***至出血部位，并注入了发挥所期望的粘弹性特性的粘弹性组合物时，如图10所示，在从摄像机得到的视野中能够明确地掌握出血部位2。
(5)操作性的评价方法
由于视野确保用的粘弹性组合物通过内窥镜的钳子口(内径2.8～3.8mm)注入消化道内，因此，理想的是能够没有过度阻力地顺利地注入。将损耗角正切、硬度以及粘度不同的粘弹性组合物填充至50mL注射器(株式会社J.M.S)，在注射器顶端装配模拟了内窥镜的钳子口内径的导管(内径3mm、长度1.000mm)，主观地判定了粘弹性组合物的通过性。将能够顺利地通过、或者虽然有一些阻力但在实用允许范围的粘弹性组合物判定为“适合”。另一方面，将阻力过大而不实用、或者阻力过大而无法通过的粘弹性组合物判定为“不适合”。
[试验例1]关于粘弹性组合物的损耗角正切、硬度以及粘度的关系
制备损耗角正切、硬度以及粘度不同的粘弹性组合物，对于各粘弹性组合物判定视野确保以及操作性，对于各物性值和相关性进行了评价。视野确保被判定为“合格”的粘弹性组合物的损耗角正切均约为0.6以下，当超过该值时均为“不合格”(图6)。操作性被判定为“适合”的粘弹性组合物的硬度约为550N/m2以下，粘度约为2000mPa·s以下，当超过该值时均为“不适合”(图7)。满足视野确保为“合格”以及操作性为“适合”这两者的粘弹性组合物的损耗角正切以及硬度为与上述相同的值(图8)。根据这些实验例可知，优选的是，内窥镜治疗时的视野确保以及操作性优异的粘弹性组合物的损耗角正切设为0.6以下，硬度设为550N/cm2以下，粘度设为200～2000mPa·s。
[试验例2]关于粘弹性组合物的电导率
在利用内窥镜进行的止血中，有如下三种方法：基于使用了高频电流的热凝固的方法、使用夹子(clip)的方法、使用药剂的方法。在热凝固法中，高频电流流过出血部，并通过在出血部位集中产生的热量对组织进行凝固止血。此时，一般而言，当在出血部位周围存在电导率高的溶液或物质时，高频电流会漏电，无法进行充分的热凝固。
基于该见解，按以下的步骤进行了处理以及评价。
使小筒(直径约1.5cm)压接于大鼠的肝表面，将其中用生理盐水、蒸馏水、或者以电导率不同的方式制备出的粘弹性组合物来填充，将单极的顶端(Edge coating blade电极E1450X)轻轻地抵至肝表面，在凝固模式(SurgiStat II、Covidien Japan株式会社、设定凝固输出为20)下通电2秒钟。在气相中(图11)以及电导率低的自来水中(图12)观察到充分的热凝固，但在电导率高的生理盐水中(图13)发现热凝固不良。另外，在电导率为12.8mS/m(128μS/cm)以下的粘弹性组合物(图14、图15)中观察到充分的热凝固，另外，在25mS/m(250μS/cm)以下、例如22.4mS/m(224μS/cm)以下的粘弹性组合物(图16)中，观察到实用上没问题的程度的热凝固，但是在大电导率、例如60.8mS/m(608μS/cm)(图17)中发现热凝固不良。根据这些实验例可知，考虑到使用了高频电流的热凝固止血，内窥镜治疗时的视野确保以及操作性优异的粘弹性组合物的电导率优选为25mS/m以下，进一步优选为20mS/m以下。将结果也示于以下的表1。
[表1]
表1 粘弹性组合物的电导率(热凝固)
*E：优异(观察到充分的热凝固)
G:好(观察到热凝固)
NG:不好(热凝固不充分)
在以下的表2中示出了：在内窥镜治疗时的操作性中评价为“适合”，还实现使用了高频电流的热凝固的粘弹性组合物，对于各个粘弹性组合物也一起示出了视野确保的合格与否。
[表2]
附图标记说明：
1 内窥镜前端部
2 出血部位
3、3’ 血液
3” 浑浊水
11 刻度盘
12 镜体连接器部
13 管
14 连接器
15 钳子口
16 钳子盖
17 内窥镜软性管

Claims (5)

1.一种粘弹性组合物，其为内窥镜的视野确保用的粘弹性组合物，其中，
含有增粘性物质和水。
2.根据权利要求1所述的粘弹性组合物，其中，
硬度为550N/m2以下，25℃时的粘度为200～2000mPa·s，损耗角正切为0.6以下。
3.根据权利要求2所述的粘弹性组合物，其中，
进一步，电导率为250μS/cm以下。
4.一种确保内窥镜的视野的方法，其包括：
将权利要求1～3中任一项所述的粘弹性组合物从内窥镜的手边部通过通道送入内窥镜的前端部。
5.根据权利要求4所述的方法，其中，
内窥镜为医疗用内窥镜。
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