TWI655955B - 用於細胞治療與具有幹細胞無致敏性的水性聚氨酯結構及其材料 - Google Patents

用於細胞治療與具有幹細胞無致敏性的水性聚氨酯結構及其材料 Download PDF

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TWI655955B
TWI655955B TW107113255A TW107113255A TWI655955B TW I655955 B TWI655955 B TW I655955B TW 107113255 A TW107113255 A TW 107113255A TW 107113255 A TW107113255 A TW 107113255A TW I655955 B TWI655955 B TW I655955B
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Taiwan
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cell
stem cells
adhesive layer
moisture
bearing structure
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TW107113255A
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English (en)
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TW201943429A (zh
Inventor
枋啟豪
俞亭君
賴孟恒
柯錦和
薛光瑩
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財團法人塑膠工業技術發展中心
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Priority to TW107113255A priority Critical patent/TWI655955B/zh
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Publication of TWI655955B publication Critical patent/TWI655955B/zh
Priority to US16/383,791 priority patent/US20190322091A1/en
Priority to CN201910304612.2A priority patent/CN110384819A/zh
Publication of TW201943429A publication Critical patent/TW201943429A/zh

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Abstract

一種用於細胞治療與具有幹細胞無致敏性的水性聚氨酯結構及材料,其包含層疊的防水透濕片及功能黏著層;該防水透濕片為一水性聚氨酯材料所製成,其包含相互聚合之硬鏈段:雙異氰酸酯、鏈延長劑,以及軟鏈段:多元醇、擴鏈劑,該鏈延長劑包含乙二胺或對苯二胺;該多元醇包含聚醚多元醇或聚酯多元醇,該擴鏈劑包含2,2-二羥甲基丙酸,並利用有機鋅或有機鉍催化劑催化反應;本發明透過材料選用與製程參數調控,對於細胞或幹細胞皆無致敏性,並具有優異生物相容性,可應用於細胞輔助治療與相關產品之開發。

Description

用於細胞治療與具有幹細胞無致敏性的水性聚氨酯結構及其材料
一種幹細胞無致敏結構,特別是一種用於細胞治療與具有幹細胞無致敏性的水性聚氨酯結構及其材料
目前常見的醫用敷料,例如紗布或OK繃,主要用於披覆傷口,形成封閉環境,提供阻隔外界污染與防止外物進入的功能,但此種醫用敷料僅單純具有隔絕的效果,對於慢性傷口(如糖尿病患者肢端深度潰瘍傷口)或是嚴重燒燙傷等,需要提供積極治療的患者而言,此種敷料並無法進一步提供促進傷口癒合及輔助治療的功能,且還可能因為敷料所使用的材料對細胞或幹細胞相容性不佳,以致於治療效果不彰的問題,目前缺乏一種既可披覆傷口阻隔外界環境,又可用於輔助治療並促進傷口癒合且無致敏的材料。
為了解決目前常見醫用敷料,對於嚴重傷口或慢性癒合傷口無法提供促進傷口癒合及輔助治療的功能,且材料可能對細胞或幹細胞相容性不佳,以致於治療效果不彰的問題,本發明提供一種用於細胞治療與具有幹細胞無致敏性的結構,其包含一防水透濕片及一功能黏著層,其中:該防水透濕片包含一透濕片頂面及一透濕片底面,該功能黏著層附於該透濕片頂面;該防水透濕片為一用於細胞治療與幹細胞無致敏性的水性聚氨酯材料所製成,該用於細胞治療與幹細胞無致敏性的水性聚氨酯材料包含相互聚合之一硬鏈段及一軟鏈段,其中:該硬鏈段包含一雙異氰酸酯以及一鏈延長劑,該鏈延長劑為乙二胺或對苯二胺;該軟鏈段包含一多元醇以及一擴鏈劑,該多元醇包含聚醚多元醇或聚酯多元醇,該擴鏈劑為2,2-二羥甲基丙酸;以及該用於細胞治療與幹細胞無致敏性的水性聚氨酯材料以一催化劑於90~95 oC溫度下反應,該催化劑為有機鋅或有機鉍催化劑。
其中,複數幹細胞附於該功能黏著層上。
其中,該用於細胞治療與具有幹細胞無致敏性的結構進一步包含一細胞承載結構,該細胞承載結構具有一承載結構頂面與一承載結構底面,該細胞承載結構以該承載結構底面附於該功能黏著層上;以及該細胞承載結構承載複數幹細胞,且該細胞承載結構具有生物可分解特性。
其中,該防水透溼片與該功能黏著層間進一步包含一壓感黏著層,該功能黏著層與該壓感黏著層間的黏著度大於該功能黏著層與該細胞承載結構間的黏著度,使該細胞承載結構可拆卸地與該功能黏著層、該壓感黏著層及該防水透濕片分離。
其中,該細胞承載結構為扁平片狀之一薄膜並至少一層貼附於該防水透濕片上。
其中,該細胞承載結構為扁平片狀的一發泡體,並均勻分布一孔隙結構,該孔隙結構的孔徑大小為50~300μm,孔隙率80%以上。
其中,該細胞承載結構為一天然或人工合成之水膠。
其中,該功能黏著層的材料包含油性膠、水性膠或矽膠,該油性膠包含聚丙烯膠體,該功能黏著層內含抗菌、生長因子且具有吸水功能。
本發明進一步提供一種用於細胞治療與具有幹細胞無致敏性的水性聚氨酯材料,其包含相互聚合之一硬鏈段及一軟鏈段,其中:該硬鏈段包含一雙異氰酸酯以及一鏈延長劑,該鏈延長劑為乙二胺或對苯二胺;該軟鏈段包含一多元醇以及一擴鏈劑,該多元醇包含聚醚多元醇或聚酯多元醇,該擴鏈劑為2,2-二羥甲基丙酸;以及該用於細胞治療與具有幹細胞無致敏性的水性聚氨酯材料以一催化劑於90~95 oC溫度下反應,該催化劑為有機鋅或有機鉍催化劑。
其中,該用於細胞治療與具有幹細胞無致敏性的水性聚氨酯材料係為膜或片狀結構。
藉由上述說明可知,本發明具有以下優點:
1. 本發明係一種新型的水性聚氨酯材料,透過材料選用與製程參數調控,使得本發明不僅可用於細胞治療的用途,且材料無致敏性,對細胞,甚至是幹細胞皆具有優異生物相容性,可促進傷口癒合,相當適合應用於細胞治療輔助材料與相關產品開發。
2. 本發明具有高彈性與高透光性,作為治療傷口之醫用敷料可提供傷口完整包覆、阻隔外界有害物質,並藉由高透光性,有助於觀察傷口治療與癒合情形。
一種用於細胞治療與具有幹細胞無致敏性的水性聚氨酯材料,其包含相互聚合的一硬鏈段及一軟鏈段,該硬鏈段包含雙異氰酸酯(Aliphatic Isocyanates)以及一鏈延長劑,該軟鏈段包含一多元醇(Polyol)以及一擴鏈劑。
前述該硬鏈段中的該雙異氰酸酯可以是脂肪族雙異氰酸酯或脂環族雙異氰酸酯,該鏈延長劑則較佳是乙二胺(Ethylenediamine, EDA)或對苯二胺(p-phenylenediamine, PDA);該軟鏈段中的該多元醇為聚醚多元醇或聚酯多元醇,該擴鏈劑較佳是2,2-二羥甲基丙酸(DMPA)具有優異的生物相容性。
其中,本發明該硬鏈段中異氰酸酯官能基團(NCO)與該軟鏈段中羥基團(OH)的莫耳比介於1.70:1~1.80: 1,較佳為1.77:1,此莫耳比範圍在於水性聚氨酯材料若具有較高比例的異氰酸酯官能基團(NCO)可具有較佳的生物相容性,更甚者,本發明能產生優異的幹細胞相容性。
本發明的製造方法,其步驟包含:
合成階段:將該多元醇加熱至80 oC至少8小時,將加熱後的該多元醇與該擴鏈劑於真空狀態(750~760 mmHg)並維持溫度90-100 oC抽氣除水40~60分鐘後,降溫至70 oC,加入該雙異氰酸酯混合均勻,再加入一催化劑以90~95 oC溫度下進行反應。
測定與預聚物製備階段:接著以二正丁胺滴定標準測定反應之NCO莫耳比或重量百分比達到標準為滴定終點。待確認滴定終點後,將聚合物降溫至50~80 oC後,於降溫過程中可選擇性地加入MEK/Acetone調節聚合物黏度並混合均勻,接著加入中和劑TEA中和反應約30分鐘,得一水性聚氨酯預聚物。
水乳分散階段:將該水性聚氨酯預聚物以1000~2000RPM之轉速分散,並加入純水使該水性聚氨酯預聚物於水相中進行分散,再加入低溫的EDA水溶液使鏈段延長,並持續攪拌1小時後靜置消泡,即完成本發明該具有幹細胞相容性與無致敏的水性聚氨酯材料。
前述合成階段所使用之該催化劑作用在於加速與促進合成反應,該催化劑種類較佳是具有優異生物相容性的催化劑,例如T12、C82、Z22等有機鋅或有機鉍催化劑,且添加量較佳在0.0005wt%,並且搭配本案將催化劑反應溫度設定為90~95 oC,可進一步加速反應速率並使反應更完全,並且減少重金屬物質的殘留量,有助於本發明達到具有較高莫耳比例的異氰酸酯官能基團(NCO)之高生物相容性訴求。
配合上述製程,本發明所提供的配方比例範圍較佳如下: <TABLE border="1" borderColor="#000000" width="85%"><TBODY><tr><td> 材料 </td><td> 名稱 </td><td> 添加量(mole) </td></tr><tr><td> 雙異氰酸酯 </td><td> IPDI/H12MDI </td><td> 0.264-4.764 </td></tr><tr><td> 多元醇 </td><td> PTMEG650/1000/2000 </td><td> 0.070-1.315 </td></tr><tr><td> 擴鏈劑 </td><td> DMPA </td><td> 0.076-1.374 </td></tr><tr><td> 催化劑 </td><td> T12/(C83、Z22) </td><td> 適量 </td></tr><tr><td> 中和劑 </td><td> TEA </td><td> 0.470-1.415 </td></tr><tr><td> 鏈延長劑 </td><td> EDA/PDA </td><td> 0.088-1.660 </td></tr></TBODY></TABLE>
進一步地,為了證實本發明具有幹細胞相容性與無致敏的功效,以下為使用前述製程所得本發明五個較佳實施範例之確效性相關測試說明。
本發明材料配方實施例1 <TABLE border="1" borderColor="#000000" width="85%"><TBODY><tr><td> 材料 </td><td> 名稱 </td><td> 添加量 (mole) </td></tr><tr><td> 雙異氰酸酯 </td><td> IPDI </td><td> 0.385 </td></tr><tr><td> 多元醇 </td><td> PTMEG650 </td><td> 0.191 </td></tr><tr><td> 擴鏈劑 </td><td> DMPA </td><td> 0.076 </td></tr><tr><td> 催化劑 </td><td> C83、Z22 </td><td> 適量 </td></tr><tr><td> 中和劑 </td><td> TEA </td><td> 0.078 </td></tr><tr><td> 鏈延長劑 </td><td> PDA </td><td> 0.100 </td></tr></TBODY></TABLE>
本發明材料配方實施例2 <TABLE border="1" borderColor="#000000" width="85%"><TBODY><tr><td> 材料 </td><td> 名稱 </td><td> 添加量 (mole) </td></tr><tr><td> 雙異氰酸酯 </td><td> H12MDI </td><td> 0.368 </td></tr><tr><td> 多元醇 </td><td> PTMEG650 </td><td> 0.175 </td></tr><tr><td> 擴鏈劑 </td><td> DMPA </td><td> 0.076 </td></tr><tr><td> 催化劑 </td><td> C83、Z22 </td><td> 適量 </td></tr><tr><td> 中和劑 </td><td> TEA </td><td> 0.078 </td></tr><tr><td> 鏈延長劑 </td><td> PDA </td><td> 0.100 </td></tr></TBODY></TABLE>
本發明材料配方實施例3 <TABLE border="1" borderColor="#000000" width="85%"><TBODY><tr><td> 材料 </td><td> 名稱 </td><td> 添加量 (mole) </td></tr><tr><td> 雙異氰酸酯 </td><td> H12MDI </td><td> 0.264 </td></tr><tr><td> 多元醇 </td><td> PTMEG2000 </td><td> 0.070 </td></tr><tr><td> 擴鏈劑 </td><td> DMPA </td><td> 0.076 </td></tr><tr><td> 催化劑 </td><td> C83、Z22 </td><td> 適量 </td></tr><tr><td> 中和劑 </td><td> TEA </td><td> 0.078 </td></tr><tr><td> 鏈延長劑 </td><td> EDA </td><td> 0.100 </td></tr></TBODY></TABLE>
本發明材料配方實施例4 <TABLE border="1" borderColor="#000000" width="85%"><TBODY><tr><td> 材料 </td><td> 名稱 </td><td> 添加量 (mole) </td></tr><tr><td> 雙異氰酸酯 </td><td> IPDI </td><td> 0.385 </td></tr><tr><td> 多元醇 </td><td> PTMEG650 </td><td> 0.191 </td></tr><tr><td> 擴鏈劑 </td><td> DMPA </td><td> 0.076 </td></tr><tr><td> 催化劑 </td><td> C83、Z22 </td><td> 適量 </td></tr><tr><td> 中和劑 </td><td> TEA </td><td> 0.078 </td></tr><tr><td> 鏈延長劑 </td><td> EDA </td><td> 0.100 </td></tr></TBODY></TABLE>
本發明材料配方實施例5 <TABLE border="1" borderColor="#000000" width="85%"><TBODY><tr><td> 材料 </td><td> 名稱 </td><td> 添加量 (mole) </td></tr><tr><td> 雙異氰酸酯 </td><td> IPDI </td><td> 0.330 </td></tr><tr><td> 多元醇 </td><td> PTMEG1000 </td><td> 0.137 </td></tr><tr><td> 擴鏈劑 </td><td> DMPA </td><td> 0.076 </td></tr><tr><td> 催化劑 </td><td> C83、Z22 </td><td> 適量 </td></tr><tr><td> 中和劑 </td><td> TEA </td><td> 0.078 </td></tr><tr><td> 鏈延長劑 </td><td> EDA </td><td> 0.100 </td></tr></TBODY></TABLE>
請參考圖1,其為本發明生物相容性之測試結果,其中,圖1顯示之BK組別為無樣品的培養對照組(正常培養)、Positive control為100%的ZDEC (Zinc diethyldithiocarbamate)、Negative control 為以錫類作為催化劑所合成的水性聚氨酯材料進行萃取後測試、以及實施例1~5即為前述本發明五種實施例。是自圖1可知,細胞存活率分別是BK 為100% , Positive control為4.5%, Negative control 為86.3%,實施例1~5分別為100%、 100% 、 100% 、99.7%、100%。 Positive control組顯示對於細胞毒殺後存活率極低,且Negative control則明顯減少細胞存活率的趨勢。但實施例與BK組活細胞數趨勢相同,具較高生物相容性。
請參考圖2,本發明選用實施例三與前述Positive control及Negative control組別之脂肪幹細胞共培養24小時後,在100倍顯微鏡下觀察細胞型態,自圖2可知,Positive control組與Negative control 、實施例3組別脂肪幹細胞皆呈現纖維狀型態。Positive control組的細胞密度相較Negative control和實施例3組別高, Negative control和實施例3組之間則無明顯差異,可知本發明具備幹細胞生物相容性。
進一步地,請參考圖3~圖5,本發明的脂肪幹細胞相關測試,包含脂肪幹細胞存活率測試(圖3)、脂肪幹細胞增生能力測試(圖4)以及脂肪幹細胞分化能力測試(圖5)。
請參考圖3之細胞存活率測試,利用實施例三與前述Positive control及Negative control組別分別與脂肪幹細胞共培養24小時後,測試脂肪幹細胞存活影響,圖3中(a)為活細胞數目,圖3中(b)為細胞存活率,*表示 p值<0.05,***表示 p值<0.01皆為統計上具顯著差異。自圖3可知,Positive control組的活細胞數為1.7x10 5cells,Negative control為1.22 x10 5cells,實施例3為1.6 x10 5cells。 Negative control與脂肪幹細胞共培養24小時後,明顯減少細胞存活數目( p值=0.0017)。而實施例3組別與Positive control組相比則無明顯差異( p值=0.388)。進一步計算細胞存活率,將Negative control和實施例3的活細胞數與Positive control組相比,細胞存活率分別是Negative control為71.84% ( p值=0.0035),實施例3為94.01% ( p值=0.185),結果與活細胞數趨勢相同, Negative control與脂肪幹細胞共培養24小時後,明顯減少細胞存活率,實施例3組別則無明顯差異。自此實驗可知,本發明的細胞存活率高。
請參考圖4之脂肪幹細胞增生能力測試,利用實施例三與前述Positive control及Negative control組別分別與脂肪幹細胞經過低密度14天的共培養後,使用Giemsa Stain進行染色,分析其脂肪幹細胞之增生能力,Giemsa Stain染劑可以將細胞核染為藍紫色而細胞質為淺藍色,因此細胞進行群聚觀察,由圖4電子顯微鏡40倍率的觀察結果顯示,Positive control組與Negative control 、實施例3培養皿上皆有圓型的細胞群落發展,增生能力Positive control >實施例3 > Negative control。
請參考圖5之脂肪幹細胞分化能力測試,利用實施例三與前述Positive control及Negative control組別分別以脂肪、硬骨分化液分別經過14天的培養後使用Oil Red O染色,以電子顯微鏡40倍率觀察顯示脂肪分化能力Positive control=實施例3 > Negative control。Positive control組與實施例3培養皿上皆有紅色Oil Red O染劑染於細胞質油滴,Negative control組則無。
本發明該具有幹細胞相容性與無致敏的水性聚氨酯材料除了前述具有生物與幹細胞相容性外,也同時具有優異機械、透濕與透光特性,測定相關性質數據如下表1,其係將本發明塗佈為膜厚度20~50μm之薄膜所測定: <TABLE border="1" borderColor="#000000" width="85%"><TBODY><tr><td> 性質 </td><td> 數值 </td></tr><tr><td> 斷裂強度 (kgf/cm<sup>2</sup>) </td><td> 90~250 </td></tr><tr><td> 延伸率 (%) </td><td> 230~340 </td></tr><tr><td> 透濕率 (g/m<sup>2</sup>∙d) </td><td> 500~1200 </td></tr><tr><td> 透光率 (%) </td><td> > 90 </td></tr></TBODY></TABLE>
本發明水性聚氨酯材料所製成的薄膜或片材,不僅可高度阻隔外界環境,還具有高彈性、高透濕率及良好的透光性,具有優異的生醫材料用途。
請參考圖6,本發明進一步提供一種用於細胞治療與具有幹細胞無致敏性的結構10,其包含相互層疊的一防水透濕片11及一細胞承載結構13。該細胞承載結構13包含一承載結構頂面131與一承載結構底面133,該細胞承載結構13係以該承載結構底面133附於該防水透濕片11上。
進一步地,為了使該細胞承載結構13與該防水透濕片11更加牢固固定,該防水透濕片11與該細胞承載結構13間可利用一壓感黏著層12與一功能黏著層14相互貼附連接,該防水透濕片11包含一透濕片頂面111及一透濕片底面113,該壓感黏著層12覆於該透濕片頂面111。該功能黏著層14覆於該承載結構底面133並與該壓感黏著層12相互貼合,使該細胞承載結構13可固定於該防水透濕片11上,且較佳地該細胞承載結構13的面積大小小於該壓感黏著層12披覆於該防水透濕片11上的面積大小,使該細胞承載結構13固定於該防水透濕片11上時,局部的該壓感黏著層12可外露,以便於貼附在使用者的皮膚上。
該壓感黏著層12主要是提供本發明固定貼附於患者皮膚的功用,其材料主要可為壓克力膠體(Acrylic Adhesive)。
其中,該防水透濕片11主要為平面片狀或膜狀,並具有優異的延展彈性防水透濕功能,其材質即為前述本發明之用於細胞治療與幹細胞無致敏性的水性聚氨酯材料,具有良好的透光度、物化性質以及高生物相容性,更佳具有生物可分解特性,並且可藉由配方調整達到調控分解速率以及高透明度的功能,適用於組織抗沾黏薄膜、眼科、牙科、骨科植入物以及藥物傳輸介質使用。
該功能黏著層14較佳地對於其黏附的該壓感黏著層12與該細胞承載結構13間有黏著度上的差異,該功能黏著層14對於該壓感黏著層12的黏著度大於該功能黏著層14對於該細胞承載結構13的黏著度,使該細胞承載結構13僅暫時性地固定於該功能黏著層14上,並可拆卸地與該功能黏著層14、該壓感黏著層12及該防水透濕片11分離。
該功能黏著層14也同時具有良好生物相容性,材質包含油性膠、水性膠或矽膠,依據其內含之功能性材料的特性可選用油性膠或水性膠,當功能性材料的為油性成分時,油性膠可如聚丙烯膠體(Polypropylene Adhesive),當功能性材料為水溶性時可選用水性膠,該功能黏著層14除了提供暫時性固定該細胞承載結構13的功能外,其內含之功能性材料可提供組織液吸收、抗菌、生長因子釋放、提供幹細胞養分等功能,且其與該細胞承載結構13可輕易分離,不會造成傷口沾黏的問題。
請參考圖7,本發明之該細胞承載結構13主要的功能為承載一幹細胞15,該幹細胞15包含脂肪幹細胞或間質幹細胞,該幹細胞15具有協助或甚至是加速修復患者傷口的功能,且較佳具有無致敏與生物可分解的特性,如圖9所示,本發明該細胞承載結構13的第一較佳實施例係為扁平片狀之一薄膜135以多層狀態相互堆疊而成,該幹細胞15附於每層該薄膜135之表面,但實際實施上僅需要至少一層附有該幹細胞15的該薄膜135即可達到修復傷口的功能,本實施例係示例多層疊合的狀態。另外,由於本發明之該功能黏著層14具有適宜幹細胞生存的條件,因此本發明亦可無需使用該細胞承載結構13,而直接將該幹細胞15附於該功能黏著層14上使用。
請參考圖8,本發明該細胞承載結構13第二較佳實施例為片狀的一發泡體137,或亦可稱泡綿,該發泡體137均勻分布一孔隙結構139,該孔隙結構的孔徑大小為50~300μm,孔隙率80%以上,該孔隙結構139可作為承載與貼附該幹細胞15的細胞支架,提供一定的細胞遷徙繁衍與支撐強度功能。
請參考圖9,本發明該細胞承載結構13第三較佳實施例係將該幹細胞15與一水膠G混合後,直接塗敷於傷口處。其中,該水膠G的材料可為天然或人工合成材料,濃度較佳為0.5%-3%,該水膠G可作為該幹細胞15的支架,提供該幹細胞15遷徙繁衍的空間與延長滯留於治療部位的時間。較佳實施方式為將特定濃度該水膠G打入離心管內,接續加入該幹細胞15懸浮液,均勻混合攪拌完成後,使用針筒將混合體吸起並施打入傷口缺陷處,再將該防水透濕片11附於傷口外部隔絕外界環境。
前述該水膠G中,天然材料包含幾丁質(chitin)、幾丁聚醣(chitosan)、纖維蛋白(fibrin)、膠原蛋白(collagen)、明膠(gelatin)、透明質酸(hyaluronic acid,HA)、褐藻酸(alginate)和纖維素(cellulose);人工合成材料包含聚乳酸(polylactate,PLA)、聚甘醇酸(polyglycolate,PGA)及其共聚物(poly-D,L-lactide-co-glycolide , PLGA)、聚原酸酯(polyorthoester,POE)、聚己內酯(polycaprolactone,PCL)、聚酸酐(polyanhydride,PAH)、聚縮醛(polyoxymethylene,POM)。
請參考圖10,其為本發明的使用流程示意圖,當本發明以該細胞承載結構13為接觸面貼附於傷者手臂H的傷口W時,該細胞承載結構13可填補凹陷的傷口W,而外層的該防水透濕層11可透過外露的該壓感黏著層12貼附於手臂H周圍健康的皮膚上(圖2上半部圖式未顯示該壓感黏著層12及該功能黏著層14),達到封閉傷口W並阻隔外界污染物質的效果,當需要更換本發明時,由於該功能黏著層14與該壓感黏著層12及該細胞承載結構13間的黏著度差異,使得該細胞承載結構13可輕易地與其他部分分離,該細胞承載結構13依然保持於傷口上,減少新生組織隨著本發明剝除而產生的二次傷害。
上述僅為本發明的較佳實施例而已,並非用以限定本發明主張的權利範圍,凡其它未脫離本發明所揭示的精神所完成的等效改變或修飾,均應包括在本發明的主張範圍內。
10‧‧‧用於細胞治療與具有幹細胞無致敏性的結構
11‧‧‧防水透濕片
111‧‧‧透濕片頂面
113‧‧‧透濕片底面
12‧‧‧壓感黏著層
13‧‧‧細胞承載結構
131‧‧‧承載結構頂面
133‧‧‧承載結構底面
135‧‧‧薄膜
137‧‧‧發泡體
139‧‧‧孔隙結構
14‧‧‧功能黏著層
15‧‧‧幹細胞
H‧‧‧手臂
W‧‧‧傷口
G‧‧‧水膠
圖1為本發明生物相容性測試圖。 圖2為本發明脂肪幹細胞型態圖。 圖3為本發明脂肪幹細胞存活率測試圖。 圖4為本發明脂肪幹細胞增生能力測試圖。 圖5為本發明脂肪幹細胞分化能力測試圖。 圖6為本發明用於細胞治療功能的結構側視示意圖。 圖7為本發明用於細胞治療功能的結構之細胞承載結構第一較佳實施例的示意圖。 圖8為本發明用於細胞治療功能的結構之細胞承載結構第二較佳實施例的與局部放大圖。 圖9為本發明用於細胞治療功能的結構之細胞承載結構第三較佳實施例的示意圖。 圖10為本發明用於細胞治療功能的結構的使用流程示意圖。

Claims (10)

  1. 一種用於細胞治療與具有幹細胞無致敏性的結構,其包含一防水透濕片及一功能黏著層,其中: 該防水透濕片包含一透濕片頂面及一透濕片底面,該功能黏著層附於該透濕片頂面; 該防水透濕片為用於細胞治療與幹細胞無致敏性的水性聚氨酯材料所製成,該用於細胞治療與幹細胞無致敏性的水性聚氨酯材料包含相互聚合之一硬鏈段及一軟鏈段,其中: 該硬鏈段包含一雙異氰酸酯以及一鏈延長劑,該鏈延長劑為乙二胺或對苯二胺; 該軟鏈段包含一多元醇以及一擴鏈劑,該多元醇包含聚醚多元醇或聚酯多元醇,該擴鏈劑為2,2-二羥甲基丙酸;以及 該用於細胞治療與幹細胞無致敏性的水性聚氨酯材料以一催化劑於90~95 oC溫度下反應,該催化劑為有機鋅或有機鉍催化劑。
  2. 如申請專利範圍第1項的用於細胞治療與具有幹細胞無致敏性的結構,複數幹細胞附於該功能黏著層上。
  3. 如申請專利範圍第1項的用於細胞治療與具有幹細胞無致敏性的結構,其進一步包含一細胞承載結構,其中: 該細胞承載結構具有一承載結構頂面與一承載結構底面,該細胞承載結構以該承載結構底面附於該功能黏著層上;以及 該細胞承載結構承載複數幹細胞,且該細胞承載結構具有生物可分解特性。
  4. 如申請專利範圍第3項的用於細胞治療與具有幹細胞無致敏性的結構,該防水透溼片與該功能黏著層間進一步包含一壓感黏著層,該功能黏著層與該壓感黏著層間的黏著度大於該功能黏著層與該細胞承載結構間的黏著度,使該細胞承載結構可拆卸地與該功能黏著層、該壓感黏著層及該防水透濕片分離。
  5. 如申請專利範圍第3或4項的用於細胞治療與具有幹細胞無致敏性的結構,該細胞承載結構為扁平片狀之一薄膜並至少一層貼附於該防水透濕片上。
  6. 如申請專利範圍第3或4項的用於細胞治療與具有幹細胞無致敏性的結構,該細胞承載結構為扁平片狀的一發泡體,並均勻分布一孔隙結構,該孔隙結構的孔徑大小為50~300μm,孔隙率80%以上。
  7. 如申請專利範圍第3或4項的用於細胞治療與具有幹細胞無致敏性的結構,該細胞承載結構為一天然或人工合成之水膠。
  8. 如申請專利範圍第1、2或3項的用於細胞治療與具有幹細胞無致敏性的結構,該功能黏著層的材料包含油性膠、水性膠或矽膠,該油性膠包含聚丙烯膠體,該功能黏著層內含抗菌、生長因子且具有吸水功能。
  9. 一種用於細胞治療與具有幹細胞無致敏性的水性聚氨酯材料,其包含相互聚合之一硬鏈段及一軟鏈段,其中: 該硬鏈段包含一雙異氰酸酯以及一鏈延長劑,該鏈延長劑為乙二胺或對苯二胺; 該軟鏈段包含一多元醇以及一擴鏈劑,該多元醇包含聚醚多元醇或聚酯多元醇,該擴鏈劑為2,2-二羥甲基丙酸;以及 該用於細胞治療與幹細胞無致敏性的水性聚氨酯材料以一催化劑於90~95 oC溫度下反應,該催化劑為有機鋅或有機鉍催化劑。
  10. 如申請專利範圍第9項的用於細胞治療與具有幹細胞無致敏性的水性聚氨酯材料,其係為膜或片狀結構。
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