TWI714642B - 黏彈性組合物及其使用 - Google Patents

黏彈性組合物及其使用 Download PDF

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Publication number
TWI714642B
TWI714642B TW105131779A TW105131779A TWI714642B TW I714642 B TWI714642 B TW I714642B TW 105131779 A TW105131779 A TW 105131779A TW 105131779 A TW105131779 A TW 105131779A TW I714642 B TWI714642 B TW I714642B
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Taiwan
Prior art keywords
endoscope
viscoelastic composition
viscosity
field
less
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TW105131779A
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English (en)
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TW201713702A (zh
Inventor
矢野智則
大畑淳
後藤敏裕
平木勇次
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學校法人自治醫科大學
日商大塚製藥工場股份有限公司
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Abstract

本發明之目的在於提供一種適於在可見度較差之較深顏色之液體蓄積於管內部而遮住內視鏡之視野時排開該液體而確保內視鏡之視野之用途且操作性優異的黏彈性組合物、及使用該黏彈性組合物之確保內視鏡之視野之方法。本發明係一種內視鏡之視野確保用黏彈性組合物及確保內視鏡之視野之方法，該內視鏡之視野確保用黏彈性組合物含有增黏性物質及水，較佳為硬度為550N/m2以下，黏度(25℃)為200~2000mPa‧s，損失正切為0.6以下，進而較佳為導電率為250μS/cm以下，該確保內視鏡之視野之方法係將該黏彈性組合物自內視鏡之手持部通過通道送入至內視鏡之前端部。

Description

黏彈性組合物及其使用
本發明係關於一種適於確保內視鏡之視野之用途之黏彈性組合物、及使用該黏彈性組合物之確保內視鏡之視野之方法。更詳細而言，係關於一種適於在可見度較差之較深之顏色之液體蓄積於管內部而遮住內視鏡之視野時排開該液體而確保內視鏡之視野之用途且操作性優異的黏彈性組合物、及使用該黏彈性組合物之確保內視鏡之視野之方法。
內視鏡可觀察消化道、膽管等較細之管之內部。但是，若血液、腸液、膽汁等遮光之較深之顏色之液體、食物殘渣或排泄物等半固形物蓄積於管之內部，則會遮住內視鏡之視野而無法充分地觀察管之內部之狀態。於此種情形時，先前係對管內部進行送水或送氣，藉此確保內視鏡視野。送水係將自來水等水注入至管內而沖洗管內部之液體或半固形物之方法。該方法雖藉由去除管內部之液體或半固形物而暫時確保視野，但去除之液體或半固形物與自來水等混合，懸浮之不透明之液體擴散至管內，仍然難以確保視野之情況亦較多。又，送氣係將空氣送入至管內部而去除管內部之液體或半固形物之方法。該方法亦雖藉由去除管內部之液體或半固形物而暫時確保視野，但於存在出血部位之情形時，難以去除血液，無法確保視野，故而出血部位之特定或止血處理之操作伴隨有困難成為問題。因此，當務之急係開發一種操作性優異且確保內視鏡之視野之方法。
另外，專利文獻1揭示一種將包含交聯之聚合物之水凝膠注入至尿道 或直腸而治療尿失禁、肛門失禁或膀胱輸尿管逆流等之方法。
專利文獻2揭示一種具有多糖類、合成聚合物及交聯劑之水凝膠組合物。該水凝膠組合物係藉由緩衝液進行交聯硬化而成為黏著性水凝膠。
專利文獻3揭示一種藉由填充生理食鹽水、或經乳酸鹽化之林葛爾氏溶液之類之生理流體，而使子宮等體腔膨脹從而對該體腔內進行治療之方法。
[先前技術文獻] [專利文獻]
[專利文獻1]日本專利特表2007-506463號公報
[專利文獻2]日本專利特表2013-510175號公報
[專利文獻3]日本專利特表2000-513970號公報
本發明之課題在於提供一種適於在可見度較差之較深之顏色之液體蓄積於管內部而遮住內視鏡之視野時排開該液體而確保內視鏡之視野之用途且操作性優異的黏彈性組合物、及使用此種黏彈性組合物之確保內視鏡之視野之方法。又，本發明之課題在於提供一種較理想為可輔助簡便之止血處理之該黏彈性組合物。
本發明者等人為了解決上述問題而進行努力研究，結果發現：使用具有黏性以及彈性之黏彈性組合物較為有用，尤其是藉由規定硬度、黏度、損失正切之物性值，內視鏡中之操作性優異，且可確保良好之視野，從而完成下述本發明。進而發現：藉由調整本發明之黏彈性組合物之導電 率，可確保良好之視野，並且輔助簡便之止血處理。
[1]一種內視鏡之視野確保用黏彈性組合物，其含有增黏性物質及水。
[2]如[1]記載之黏彈性組合物，其硬度為550N/m2以下，25℃下之黏度為200~2000mPa‧s，損失正切為0.6以下。
[3]如[2]記載之黏彈性組合物，其進而導電率為250μS/cm以下。
[4]一種確保內視鏡之視野之方法，其係將如上述[1]至[3]中任一項記載之黏彈性組合物自內視鏡之手持部通過通道送入至內視鏡之前端部，而確保內視鏡之視野。
[5]如[4]記載之方法，其中內視鏡為醫療用內視鏡。
本發明之黏彈性組合物具有黏性及彈性之性質，藉由其黏彈性，可以物理方式排開血液、腸液、膽汁等液體或者食物殘渣或排泄物等半固形物。又，本黏彈性由於不易與之前之液體或半固形物混合，故而不會懸浮，且具有適當之整齊度，因此不會擴散，可確保良好之視野。又，本發明之黏彈性組合物藉由不含有或最小限度地含有具有電荷之物質而使導電率較小，藉此可於黏彈性組合物之存在下確保視野，並且輔助藉由電氣切斷或電氣凝固等之止血處理。
1:內視鏡前端部
2:出血部位
3:血液
3':血液
3":渾濁水
4:消化道
11:轉盤
12:觀測鏡連接器部
13:管
14:連接器
15:鉗子口
16:鉗子蓋
17:內視鏡軟性管
圖1係表示醫療用內視鏡之手持部之照片之圖。
圖2A係表示出血之消化道內之狀態之概念圖。
圖2B係表示於出血之消化道內送入水時之狀態之概念圖。
圖3A係表示出血之消化道內之狀態之概念圖。
圖3B係表示於出血之消化道內送入本發明之黏彈性組合物時之狀態的概念圖。
圖4A係表示黏彈性組合物注入前之管內的概念圖。
圖4B係說明就於內視鏡使用黏彈性組合物時之視野確保之觀點而言之評價方法的圖。其又為表示本發明黏彈性組合物注入後的圖。
圖5A係表示黏彈性組合物注入前之管內的概念圖。
圖5B係說明就於內視鏡使用黏彈性組合物時之視野確保之觀點而言之評價方法的圖。其又為表示作為比較例之黏性組合物注入後的圖。
圖6係表示黏彈性組合物之黏度及損失正切與用於內視鏡時之視野確保之合格與否之關係的圖表。
圖7係表示黏彈性組合物之黏度及硬度與用於內視鏡時之操作性之適當與否之關係的圖表。
圖8係表示黏彈性組合物之硬度及損失正切與用於內視鏡時之視野確保及操作性之合格與否、適當與否之關係的圖表。
圖9係表示自內視鏡之鉗子口注入水時所獲得之相機圖像之一例的圖。
圖10係表示自內視鏡之鉗子口注入本發明黏彈性組合物時所獲得之相機圖像之一例的圖。
圖11係表示注入氣相，利用內視鏡之使用高頻電流之熱凝固處理之結果的圖。
圖12係表示注入自來水，利用內視鏡之使用高頻電流之熱凝固處理之結果的圖。
圖13係表示注入生理食鹽液，利用內視鏡之使用高頻電流之熱凝固處理之結果的圖。
圖14係表示注入導電率1.8mS/m之黏彈性組合物，利用內視鏡之使用高頻電流之熱凝固處理之結果的圖。
圖15係表示注入導電率12.8mS/m之黏彈性組合物，利用內視鏡之使用高頻電流之熱凝固處理之結果的圖。
圖16係表示注入導電率22.4mS/m之黏彈性組合物，利用內視鏡之使用高頻電流之熱凝固處理之結果的圖。
圖17係表示注入導電率60.8mS/m之黏彈性組合物，利用內視鏡理之使用高頻電流之熱凝固處理之結果的圖。
本發明之黏彈性組合物含有增黏性物質及水。
本發明之黏彈性組合物係藉由於分散於水中時組合一種或兩種以上具有提高黏度之作用之增黏性物質而製備。作為此種增黏性物質，例如可列舉：甲醇、乙醇、2-丙醇、1,4-丁二醇、1,3-丁二醇、丙二醇、甘油、兒茶素、葡萄糖、果糖、半乳糖、蔗糖、乳糖、麥芽糖、海藻糖、木糖醇、山梨醇、甘露醇、葡萄糖胺、半乳胺糖等醇類；黑酵母菌培養液、亞麻籽膠、阿拉伯膠、阿拉伯半乳糖、海藻酸及其鹽類、海藻酸丙二醇酯、文萊膠、肉桂膠、印度膠、卡德蘭多糖、角叉菜膠、刺梧桐樹膠、三仙膠、古亞膠、古亞膠酵素分解物、車前籽膠、沙蒿籽膠、結冷膠、琥珀醯聚糖、羅望子膠、塔拉膠、葡聚糖、黃耆膠、紅藻膠、海蘿膠、普魯蘭、果膠、Macrophomopsis膠、Rhamsan膠、左聚糖、刺槐豆膠、澱粉丙烯酸、乙醯基化己二酸交聯澱粉、乙醯基化氧化澱粉、乙醯基化磷酸交聯澱 粉、辛烯基丁二酸澱粉鈉、羧甲基纖維素及其鹽類、羧甲基乙基纖維素、乙酸澱粉、氧化澱粉、澱粉乙醇酸鈉、羥基丙基化磷酸交聯澱粉、羥丙基纖維素、羥丙基澱粉、羥丙基甲基纖維素、羥甲基纖維素、羥乙基甲基纖維素、羥乙基纖維素、乙基纖維素、甲基纖維素、纖維素、磷酸交聯澱粉、磷酸化澱粉、磷酸單酯化磷酸交聯澱粉、褐藻糖膠、Diutan膠、葡甘露聚糖、玻尿酸及其鹽類、硫酸角質素、肝素、硫酸軟骨素、硫酸皮膚素、硬葡聚糖、裂褶菌多糖、秋葵萃取物、木立蘆薈萃取物、田箐膠、瓊脂糖、洋菜硫糖、直鏈澱粉、支鏈澱粉、α化澱粉、菊糖、左聚糖、Graminan、瓊脂、疏水化羥丙基甲基纖維素、澱粉乙醇酸鈉、葡聚糖、糊精、交聯羧甲基纖維素鈉、葡糖醛酸木聚糖、阿拉伯木聚糖等多糖類；明膠、水解明膠、膠原蛋白等蛋白質；聚麩胺酸、聚離胺酸、聚天冬胺酸等聚胺基酸；羧基乙烯基聚合物、聚丙烯酸及其鹽類、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、聚丁二醇等親水性高分子；氯化鈣、氫氧化鋁、氯化鎂、硫酸銅等金屬鹽等。
本發明之黏彈性組合物中所使用之水並無特別限制，較佳為軟水、純水、脫離子水、蒸餾水等、或生理食鹽水、林葛爾氏液、乙酸林葛爾氏液等生理水溶液。
本發明之黏彈性組合物可含有保存劑、防腐劑等添加劑。
本發明之課題在於提供一種操作性優異且可確保良好之視野之黏彈性組合物，較理想為提供一種可輔助簡便之止血處理之黏彈性組合物，於該等課題中，認為遮住內視鏡之視野之要因在於血液、腸液、膽汁等液體或者食物殘渣或排泄物等半固形物1)蓄積於管腔內；2)與水混合而有損透 明性；3)藉由送水進行流動或擴散。為了良好地確保視野，藉由將具有與血液、腸液、膽汁等液體或排泄物等半固形物不同之黏彈性之透明組合物注入至管腔內而以物理方式排開、去除該等物質，藉此可確保空間，並且不易與血液、腸液、膽汁等液體或排泄物等半固形物混合，抑制液體之流動或擴散。又，操作性優異之問題意味著可於不存在過度之阻力之情況下使該黏彈性組合物通過內視鏡之鉗子口。可輔助簡便之止血處理之問題意味著可於該黏彈性組合物之存在下確認出血部位，又，可輔助使用高頻電流之止血處理。
本發明之黏彈性組合物較佳為硬度為550N/m2以下，較佳為400N/m2以下，黏度(25℃)為200~2000mPa‧s，較佳為500~1500mPa‧s，損失正切為0.6以下。
藉由將硬度設為上述範圍，通過內視鏡之通道之注入時之操作性變得良好。又，藉由將黏度及損失正切設為上述範圍，就視野確保之觀點而言得到改善。再者，就視野確保之觀點而言，黏彈性組合物可為透明。
又，本發明之黏彈性組合物之導電率較佳為250μS/cm以下，進而較佳為200μS/cm以下。
又，藉由將導電率設為上述範圍，可獲得能夠抑制漏電，尤其適於電氣切斷或電氣凝固等處理之黏彈性組合物。
本發明之黏彈性組合物係藉由將如上所述之增黏性物質與水進行混合而獲得，具體而言，藉由組合兩種以上該增黏性物質，或者使一種增黏性物質溶解於水等中，實施加熱處理而附加彈性等而獲得。本發明之黏彈性組合物若於其中有氣泡則遮住視野，故而較佳為實質上不具有氣泡。
本發明之確保內視鏡之視野之方法包括將本發明之黏彈性組合物自 內視鏡之手持部通過通道送入至內視鏡之前端部。
圖1係表示作為內視鏡之代表例之醫療用內視鏡之手持部之照片的圖。於手持部具備：轉盤11，其係用以進行角度操作；觀測鏡連接器部12，其係用以自光源裝置傳輸光，向電子內視鏡用處理器傳輸圖像資訊；及鉗子口15，其係用以插入鉗子等處理用具類而送至前端部1。於內視鏡軟性管17中設置有將鉗子口至前端部連通之通道、用於前端部之透鏡之水清洗等之送水管、光學系統等。於圖1所示之醫療用內視鏡之鉗子口15安裝有鉗子蓋16。管13之一端與鉗子蓋16連接，管之另一端與用以安裝注射器等之連接器14連接。於鉗子蓋16中有閥體，管13之一端係於鉗子蓋16內之閥體之鉗子口15側之壁面開口，於插入鉗子等處理用具類時，藉由閥體，通過管而輸送之液體亦不會流出(例如，參照日本專利特開2014-155677號公報)。
[實施例]
參考例
可將內視鏡插入至例如直腸等消化道，藉由內視鏡觀察消化道內。若於消化道4有出血，則血液3蓄積於消化道內而無法觀察出血部位2(圖2A)。此時，嘗試對注射器填充自來水，藉由該注射器，經過管13、鉗子口15及通道，自內視鏡前端部1之開口將水送入至消化道，藉由水沖洗蓄積之血液。但是，蓄積之血液與送入之水混合而懸浮，成為渾濁水3"。若渾濁水3"蓄積於消化道內，則內視鏡之視野被渾濁水3"遮住，無法觀察出血部位2，無法繼續進行手術(圖2B、圖9)。
再者，根據本發明之黏彈性組合物，如圖3A、圖3B所示，於在消化道4產生出血部位2之情形時，自內視鏡之前端部送入該黏彈性組合物，藉 此可排開消化道內蓄積之血液3(血液3')，觀察出血部位2。
實施例及比較例
於本實施例或比較例中，對內視鏡中使用之黏彈性組合物之黏彈性特性與內視鏡操作中之視野之確保及操作性的關係進行研究。
以下，示出黏彈性組合物之物性值之測定方法、以及就於內視鏡使用黏彈性組合物時之視野確保之觀點及操作性之觀點而言的評價方法。
(1)黏度及損失正切
使用黏度‧黏彈性HAAKE RS-6000(Thermo Fisher Scientific股份有限公司)進行測定。將黏彈性組合物置於試樣台，使用P35 Ti L平行板進行測定(測定條件：溫度25℃，間隙1.000mm，應力1000mPa，頻率0.5000Hz)，測量開始測定30分鐘後之值。
(2)硬度
使用蠕變儀Model RE2-33005C(山電股份有限公司)進行測定。於不鏽鋼培養皿(外徑45mm，內徑41mm，外尺寸18mm，內尺寸15mm)填滿黏彈性組合物，與培養皿之高度一致並使檢體表面平坦。使用柱塞(山電股份有限公司，形狀：圓板，型式：P-56，要點：
Figure 105131779-A0305-02-0010-3
20×t 8)進行測定(測定條件：儲存間距0.02sec，測定變形率66.67%，測定速度10mm/sec，回流距離5.00mm，樣本厚度15.00mm，接觸面直徑20.00mm，接觸面積0.000mm2)。
(3)導電率
使用導電率計CM-41X(東亞DKK股份有限公司)、低導電率用CT-57101C單元進行測定(測定條件：溫度25℃)。
(4)視野確保之評價方法
於迪安-斯塔克管中注入1%伊凡氏藍溶液(色素溶液)3mL，插入安裝有金屬絲之導管。於該狀態下，視野因色素溶液而被遮住，看不見管前端之金屬絲(圖4A、圖5A)。通過導管(內徑2.5~3mm，長度1000mm)將損失正切、硬度及黏度不同之黏彈性組合物10mL注入至色素溶液中，目測判定視野確保之合格與否。於注入某一黏彈性組合物A時，可確保物理空間，且亦不易與色素溶液混合，故而判斷為該黏彈性組合物A發揮所需之黏彈性特性，作為黏彈性組合物判定為「合格」(圖4B)。另一方面，於注入與黏彈性組合物A不同之某一黏彈性組合物B時，物理空間之確保不明確，亦可見與色素溶液之混合，故而判斷為該黏彈性組合物B未發揮所需之黏彈性特性，作為黏彈性組合物判定為「不合格」(圖5B)。
該視野確保之評價中所獲得之結果例如與於如圖9、圖10所示之視野之提供中產生差異的情況對應。即，將內視鏡插入至出血部位，注入自來水，結果如圖9所示，自相機獲得之視野因渾濁之水而不良。又，將內視鏡插入至出血部位，注入發揮所需之黏彈性特性之黏彈性組合物時，結果如圖10所示，可於自相機獲得之視野明確地掌握出血部位2。
(5)操作性之評價方法
視野確保中使用之黏彈性組合物係通過內視鏡之鉗子口(內徑2.8~3.8mm)注入至消化道內，因此較理想為可於不存在過度之阻力之情況下順利地注入。將損失正切、硬度及黏度不同之黏彈性組合物填充至50mL注射器(JMS股份有限公司)中，於注射器前端安裝模擬內視鏡之鉗子口內徑之導管(內徑3mm，長度1000mm)，主觀判定黏彈性組合物之通過性。將可順利地通過，或者雖有若干阻力但為實用容許範圍之黏彈性組合物判定為「適當」。另一方面，將過度存在阻力而不耐實用，或者過度存 在阻力而無法通過之黏彈性組合物判定為「不適當」。
[試驗例1]關於黏彈性組合物之損失正切、硬度及黏度之關係
製備損失正切、硬度及黏度不同之黏彈性組合物，對各黏彈性組合物判定視野確保及操作性，對各物性值及關聯性進行評價。視野確保判定為「合格」之黏彈性組合物之損失正切均為約0.6以下，若成為其以上，則均為「不合格」(圖6)。操作性判定為「適當」之黏彈性組合物之硬度為約550N/m2以下，黏度為約2000mPa‧s以下，若成為其以上，則均為「不適當」(圖7)。滿足視野確保「合格」及操作性「適當」之兩者之黏彈性組合物之損失正切及硬度係與上述相同的值(圖8)。根據該等實驗例可知，內視鏡治療中之視野確保及操作性優異之黏彈性組合物較佳為損失正切設為0.6以下，硬度設為550N/m2以下，黏度設為200~2000mPa‧s。
[試驗例2]關於黏彈性組合物之導電率
藉由內視鏡之止血有藉由使用高頻電流之熱凝固進行之方法、藉由夾具進行之方法、藉由藥劑進行之方法3種方法。熱凝固法係於出血部流通高頻電流而於出血部位集中產生熱，藉由所產生之熱將組織進行凝固止血。此時，一般若於出血部位周圍存在導電率較高之溶液或物質，則高頻電流發生漏電，無法進行充分之熱凝固。
基於該見解，按照以下之順序進行處理及評價。
使小型筒(直徑約1.5cm)壓接於大鼠之肝表面，利用生理食鹽液、蒸餾水、或以導電率不同之方式製備之黏彈性組合物將其中填滿，將單極之前端(邊緣(Edge)塗佈刀片電極E1450X)輕輕地接觸肝表面，於凝固模式(SurgeStat II，Covidien Japan股份有限公司，設定為凝固輸出功率20)下 通電2秒。於氣相中(圖11)及導電率較低之自來水中(圖12)可見充分之熱凝固，但於導電率較高之生理食鹽液中(圖13)可見熱凝固不良。又，於導電率為12.8mS/m(128μS/cm)以下之黏彈性組合物(圖14、圖15)中可見充分之熱凝固，又，於25mS/m(250μS/cm)以下、例如22.4mS/m(224μS/cm)以下之黏彈性組合物(圖16)中雖可見實用上不存在問題之程度之熱凝固，但於較大之導電率、例如60.8mS/m(608μS/cm)(圖17)下可見熱凝固不良。根據該等實驗例可知，內視鏡治療中之視野確保及操作性優異之黏彈性組合物考慮使用高頻電流之熱凝固止血，導電率較佳為25mS/m以下，進而較佳為20mS/m以下。將結果亦示於以下之表1。
Figure 105131779-A0305-02-0013-1
於以下之表2中示出於內視鏡治療中之操作性中評價為「適當」且實現使用高頻電流之熱凝固之黏彈性組合物，並對各者亦一併示出視野確保之合格與否。
Figure 105131779-A0305-02-0014-2

Claims (10)

  1. 一種含有增黏性物質及水且損失正切為0.6以下之黏彈性組合物在製備內視鏡視野確保劑的使用。
  2. 如請求項1之使用，其中上述黏彈性組合物之硬度為550N/m2以下，25℃下之黏度為200~2000mPa‧s。
  3. 如請求項1之使用，其中上述黏彈性組合物之導電率為250μS/cm以下。
  4. 如請求項2之使用，其中上述黏彈性組合物之導電率為250μS/cm以下。
  5. 一種含有增黏性物質及水且導電率為250μS/cm以下之黏彈性組合物在製備內視鏡視野確保劑的使用。
  6. 如請求項5之使用，其中上述黏彈性組合物之硬度為550N/m2以下，25℃下之黏度為200~2000mPa‧s。
  7. 如請求項1至6中任一項之使用，其中上述增黏性物質包含多糖類或親水性高分子。
  8. 一種內視鏡之視野確保用黏彈性組合物，其含有增黏性物質及水，損失正切為0.6以下，硬度為550N/m2以下，且25℃下之黏度為200~2000mPa‧s。
  9. 一種內視鏡之視野確保用黏彈性組合物，其含有增黏性物質及水，損失正切為0.6以下，且導電率為250μS/cm以下。
  10. 如請求項8或9之黏彈性組合物，其中上述增黏性物質包含多糖類或親水性高分子。
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