TW202023494A - 人造血管、人造血管之製造方法以及人造血管之製造裝置 - Google Patents

人造血管、人造血管之製造方法以及人造血管之製造裝置 Download PDF

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TW202023494A
TW202023494A TW108131989A TW108131989A TW202023494A TW 202023494 A TW202023494 A TW 202023494A TW 108131989 A TW108131989 A TW 108131989A TW 108131989 A TW108131989 A TW 108131989A TW 202023494 A TW202023494 A TW 202023494A
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blood vessel
artificial blood
carbon
film
main body
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藤井泰宏
大澤晋
中谷達行
今井裕一
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國立大學法人 岡山大學
學校法人加計學園
日商Strawb股份有限公司
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Abstract

人造血管10包括人造血管主體12和覆蓋人造血管主體12之內壁的類碳膜11。由類碳膜11覆蓋的內壁係水蒸氣吸附等溫線顯示脫附遲滯現象。

Description

人造血管、人造血管之製造方法以及人造血管之製造裝置
本發明關於一種人造血管、人造血管之製造方法以及人造血管之製造裝置。
人造血管為近年來需求不斷增大的醫療用器具之一。通常使用的人造血管由延展性聚四氟乙烯(PTFE)製得的多孔質化的ePTFE(expanded-polytetrafluoroethylene;膨體聚四氟乙烯)構成。ePTFE是一種生物相容性優良的材料,然而細徑人造血管的開放性方面仍存有缺點。尤其,使用直徑小於6mm的ePTFE人造血管時,發生堵塞的風險較高。
較細的人造血管中,有使用來自於人體或動物之材料形成者,但此時該材料在安全性方面存在問題,能否穩定地供給該材料方面也存在問題。因此,需要的是來自於非生體的且不易堵塞的較細的人造血管。
為了讓由ePTFE構成的人造血管不易發生堵塞,嘗試對人造血管的內壁進行各種改性處理。例如,已經在研究在ePTFE的內壁設置適合生物體的樹脂層(例如,參照專利文獻1和專利文獻2)這樣的做法。 [先前技術文獻] [專利文獻]
專利文獻1 :日本特開2015-167822號公報。 專利文獻2 :日本特開2006-263144號公報。
(發明所欲解決之課題)
然而,這種樹脂層很容易從ePTFE的內壁剝落,不利於人造血管的長期使用。此外,因為在人造血管的內壁會形成微小的凹凸,所以巨噬細胞等免疫細胞會吸附於表面,不均勻地形成較厚的內膜,反而容易發生堵塞。
有鑑於此,本發明之目的在於提供一種能夠縮小內壁的微小凹凸且不易吸附免疫細胞的人造血管。 (用以解決課題的手段)
本發明的人造血管之一樣態包括:人造血管主體、以及覆蓋人造血管主體之內壁的類碳膜;由前述類碳膜覆蓋的內壁係以水蒸氣吸附等溫線顯示脫附遲滯現象。
在人造血管的一樣態中,由前述類碳膜覆蓋的內壁係藉由圖像分析獲得的微小算術平均粗糙度為2.5以下。
在人造血管的一樣態中,由類碳膜覆蓋的內壁對免疫細胞的吸附量能夠達到二十個/mm以下。
人造血管的製造方法之一樣態包括:將多孔性的人造血管主體配置在能夠調整內部壓力的腔室內,在已供給了含烴的原料氣體的狀態下於前述人造血管主體的內部生成電漿,用類碳膜覆蓋前述人造血管主體的內壁之工序。將前述人造血管主體收納於內徑比前述人造血管主體之外徑大的非導電性外筒內,並在該狀態下將前述人造血管主體配置在前述腔室內;將放電電極配置在前述外筒的一端部,讓前述外筒的另一端部處於開放狀態;將交流偏壓間歇地施加在前述放電電極和與前述外筒之間保持有距離的相對電極之間;由前述類碳膜覆蓋的內壁係以水蒸氣吸附等溫線顯示脫附遲滯現象。
人造血管的製造裝置之一樣態包括:能夠調整內部壓力的腔室;向前述腔室內供給烴氣體的氣體供給部;設置在前述腔室內的放電電極和相對電極;以及將交流電壓間歇地施加在前述放電電極和前述相對電極之間的電源部;將前述放電電極安裝在收納人造血管主體的外筒之一端部,將前述相對電極設置成與前述外筒保持有距離,且讓前述放電電極在該狀態下放電,藉此而在外筒內生成電漿,在前述人造血管主體的內壁形成類碳膜;由前述類碳膜覆蓋的內壁係以水蒸氣吸附等溫線顯示脫附遲滯現象。 (發明功效)
如果採用本發明的人造血管,則不易吸附免疫細胞,能夠長期地防止人造血管的堵塞。
如圖1所示,實施形態的人造血管10包括由擁有細孔13的多孔質化後的ePTFE構成的人造血管主體12、以及覆蓋主體12之內壁的類碳膜11。
在本發明中,類碳膜係指即將成為國際標準化組織(International Organization for Standardization;ISO)制定之標準化下的非晶質碳膜和類聚合物碳膜為代表的含碳膜。
由ePTFE構成的人造血管主體12的內壁存在微小的凹凸,前述微小凹凸會成為將巨噬細胞等免疫細胞吸附在人造血管內壁的踏板。藉由形成表面平滑性較高的類碳膜,能夠得到不易吸附免疫細胞的表面。
在本發明中,免疫細胞係指包括嗜中性粒細胞、嗜酸性粒細胞、巨噬細胞和淋巴細胞等白細胞。
具體而言,透過圖像分析,由類碳膜11覆蓋的人造血管10的內表面(類碳膜11的表面)的微小算術平均粗糙度(micro arithmetic average roughness;IARa)較佳為2.5以下,更佳為2.0以下,尤佳為1.5以下。此外,透過圖像分析獲得的微小均方根高度(IARq)較佳在3.0以下,更佳在2.5以下,尤佳在2.0以下。並且,依據未處理的人造血管的表面粗糙度進行了標準化,標準化後的標準化算術平均粗糙度(SIARa)較佳為0.9以下,更佳為0.7以下,尤佳為0.5以下;標準化均方根高度(SIARq)較佳為0.8以下,更佳為0.7以下,尤佳為0.5以下。IARa和IARq能夠利用實施例中介紹的方法進行測量。
較佳為,由類碳膜11覆蓋的人造血管10係以水蒸氣吸附等溫線顯示脫附遲滯現象,其氮氣吸附等溫線不顯示脫附遲滯現象。水蒸氣吸附等溫線和氮氣吸附等溫線能夠利用實施例中介紹的方法進行測量。
此外,類碳膜11覆蓋的人造血管10的內表面相對於水的接觸角,較佳為105°以下,更佳為103°以下,尤佳為100°以下。在此所說的相對於水的接觸角係能使用實施例中介紹的方法進行測量。
本實施形態的人造血管10的內表面係由類碳膜11覆蓋,與沒有用類碳膜11覆蓋的人造血管主體12相比,內表面的平滑性和親水性都提高,能夠大幅度地降低對免疫細胞的吸附量,從而能夠使血管內不易堵塞。具體而言,由類碳膜11覆蓋的人造血管10之內表面對免疫細胞的吸附量,較佳為二十個/mm以下,更佳為十五個/mm,尤佳為十個/mm以下,更尤佳為六個/mm以下。免疫細胞的吸附量能以使用實施例中介紹的方法進行測量。
本實施形態的人造血管10在已形成有類碳膜的情形下,能夠將人造血管內的類碳膜的偏差抑制到極小,從而在人造血管10的兩端部和中央部都能夠維持上述的表面狀態。具體而言,將長度為150mm的人造血管10按約每2cm的長度進行分割時,內表面的IARa、IARq、親水性以及內表面對免疫細胞的吸附量,在各部位基本上保持固定。
在圖1中,介紹了作為貫通人造血管主體12的貫通孔之細孔13。然而,人造血管主體12並不侷限於此種構造,能夠採用存在網眼狀細孔的多孔質構造,細孔13內表面也可以用類碳膜11覆蓋。此外,人造血管主體12的外壁也可以用類碳膜11覆蓋。
能夠按以下所述用類碳膜11覆蓋人造血管主體12的內壁。圖2係顯示類碳膜11的成膜裝置之一例。成膜裝置內部具有腔室101,係用來收納作為成膜對象的人造血管主體12。腔室101上連接有真空排氣部110與將成膜用氣體供向腔室101內的氣體供給部115,腔室101內部的壓力能夠調節。
本實施形態中,真空排氣部110具有真空泵112與閥113。本實施形態中,氣體供給部115具有高壓罐116與質量流量控制器(mass flow controller)117。氣體供給部115還能夠供給複數種氣體。
本實施形態中,電源部120具有電壓生成器121與放大器122,將交流電壓施加在放電電極125與相對電極126之間。相對電極126是接地電極且成為腔室101的內壁。
將收納於外筒104內的人造血管主體12配置在腔室101內。為了在外筒104的內部生成電漿,讓外筒104與人造血管主體12一樣具有非導電性。具體而言,讓外筒為塑膠等。外筒104既能夠由具有可撓性的軟質材料形成,也能夠由硬質材料形成。使外筒透明或者半透明則具有以下優點:藉由目測便能夠確認出電漿之生成情形。
將外筒104的一端部配置在放電電極125的位置,讓外筒104的另一端部則處於開放狀態。將腔室內減壓後,從氣體供給部115供給含烴之原料氣體,將交流電壓施加在放電電極125與相對電極126即腔室101的內壁之間。藉由施加交流電壓,在放電電極125周圍溫度即會上昇。因此,外筒104內的壓力會稍微低於外筒104外的壓力,在放電電極125附近會生成烴的電漿。因為外筒104的另一端部處於開放狀態,所以生成的電漿會從外筒104內移動到開放側,在外筒104整個內部生成電漿。因此,能夠在收納於外筒104內的人造血管主體12的內壁面形成類碳膜11。
只要外筒104的內徑比人造血管主體12的外徑粗,長度在足以收納整個人造血管主體12的長度以上即可。透過在將人造血管主體12收納在壁面沒有細孔等的外筒104內,能夠在壁面有細孔且內側和外側之間不易產生壓力差的多孔性人造血管主體12的內壁面上形成類碳膜11。
讓外筒104的內徑與人造血管主體12的外徑大致相等,並且讓人造血管12的外壁面和外筒104的內壁面之間幾乎沒有間隙。在此狀態下,實質上能夠僅在人造血管主體12的內側生成電漿,僅在人造血管主體12的內壁面上成膜。透過增大人造血管主體12的外壁面和外筒104的內壁面之間的間隙,藉此而會成為在人造血管主體12的外側也存在電漿的狀態。因此,不僅能夠在人造血管12的內壁面上形成膜,而且還能夠在人造血管主體12的外壁面上形成膜。
因為需要使用原料氣體對腔室101內進行充分的置換,所以在成膜前將腔室內部的壓力減壓到1×10-3 Pa至5×10-3 Pa左右較佳。原料氣體中所含有的烴能夠使用通常之CVD(chemical vapor phase deposition;化學氣相沈積)法中所使用的甲烷、乙烷、丙烷、丁烷、乙烯、乙炔與苯等。從易操作的觀點出發,甲烷較佳。將四甲基矽烷等有機矽化合物、六甲基二矽氧烷等含氧有機矽類化合物氣化後,即能夠作原料氣體用。能夠根據需要,用氬、氖以及氦等惰性氣體對原料氣體進行稀釋。從易操作的觀點出發,較佳為用氬對原料氣體進行稀釋。稀釋時將烴與惰性氣體之比率設為10:1至10:5左右較佳。
從在人造血管主體12的內壁形成均勻的類碳膜的觀點出發,較佳為,在已供給了原料氣體的狀態下腔室101內的壓力為5Pa至200Pa左右。能夠將原料氣體的流速設為50sccm至200sccm左右。
能夠將成膜時施加在放電電極125上的偏壓電壓設定在1kV至20kV左右。從防止放電電極破損、避免溫度上昇的觀點出發,偏壓電壓在10kV以下較佳。交流電壓的頻率在1kHz至50kHz左右較佳。從抑制溫度上昇的觀點出發,交流電壓為間歇施加的脈衝偏壓較佳。於使交流為***波(burst wave)之情形下,脈衝重複頻率為3pps至50pps左右較佳。雖然軟管溫度也受外筒104的內徑、成膜時間、施加的交流電壓等影響,但是藉由將脈衝重複頻率設定在30pps左右以下,便能夠將軟管溫度控制在200℃以下。於欲提高成膜速度之情形下,只要提高脈衝重複頻率即可。於欲抑制溫度上昇之情形,只要降低脈衝重複頻率即可。
為了使放電穩定以提高類碳膜的密著性,對放電電極125施加負偏置電壓較佳。能夠使偏置電壓在0kV至3kV左右。
人造血管主體12的材質並無特別限制,能夠採用多孔性的ePTFE。另外,還能夠採用聚酯和其它合成樹脂等。
人造血管主體12的內徑並無特別限定,不過較佳為10mm以下,更佳為6mm以下,尤佳為4mm以下,較佳為0.1mm以上,更佳為0.2mm以上。人造血管主體12的長度也無特別限定,如果是人造血管或者導管等時,長度較佳為2cm以上,更佳為4cm以上,尤佳為10cm以上。從均勻地成膜的觀點出發,長度較佳為5m以下,更佳為3m以下,尤佳為1.5m以下。但是,藉由調節成膜條件,也能夠在5m以上的人造血管主體12的內壁上成膜。
放電電極125只要配置到外筒104的一端部即可。本實施形態中,放電電極125配置於外筒104端部時,可以使其為以下任何一種狀態。首先,如圖3所示,至少讓放電電極125的前端位於外筒104的內部的狀態。此種情形下,放電電極125的前端可以位於人造血管主體12的內部。此外,如圖4所示,能夠使其為以下狀態:電極連接器103連接在外筒104的端部,至少讓放電電極125的前端位於電極連接器103的內部。電極連接器103能夠由絕緣性軟管等形成。在圖4中,電極連接器103為外嵌於外筒104上的軟管,不過,還能夠使電極連接器103為內嵌於外筒104上的軟管。還能夠將複數個軟管組合起來以形成電極連接器103。此種情形下,如果與外筒104相接的部分使用硬質材料,除此以外的部分使用具有可撓性的材料則容易操作。
還能夠使放電電極125的外徑比外筒104或者電極連接器103的內徑小,將原料氣體從放電電極125側的端部供向外筒104內。此外,如圖5所示,還能夠讓放電電極125為空心電極且將原料氣體供向外筒104內。
放電電極125只要具有導電性即可。例如,能夠使其為金屬。於為金屬之情形下,從耐腐蝕性等之觀點出發,不鏽鋼較佳。如果將金屬電極***細管內並使金屬電極貫穿該細管,金屬則有可能從電極朝著細管移動。但是,於使用本實施形態之成膜裝置之情形下,如果使用電極連接器103,金屬幾乎不會產生影響。於不使用電極連接器103之情形下,在與放電電極125之間的距離在5cm左右以上的位置處金屬也幾乎不會產生影響。從避免金屬產生影響的觀點出發,使放電電極125為碳電極較佳。於使用本實施方式之成膜裝置之情形下,即能夠很容易地形成碳電極。
本實施形態中,以腔室101的内壁作為相對電極126,但還能夠如圖6所示,將相對電極126配置成隔著細長管102與放電電極125相對。藉由以此方式配置相對電極126,即使讓交流電壓降低,也能夠穩定地生成電漿。並不限定於此,還能夠將相對電極126設在腔室內任一位置。即使相對電極126與外筒104接觸,也能夠生成電漿。但是,從發熱等觀點出發,較佳為將相對電極126設置成與外筒104之間保持有距離。
形成在人造血管主體12的內壁的類碳膜11的厚度雖然沒有特別限定,不過,從提高人造血管10內表面之平滑性的觀點出發,膜厚較佳為3nm以上,更佳為10nm以上。而且,從防止剝離等觀點出發,前述膜厚較佳為50nm以下,更佳為30nm以下。
雖然成膜時間受細長管的內徑、交流電壓、脈衝重複頻率等成膜條件的影響,不過,從讓人造血管主體12的內壁面完全被類碳膜11覆蓋的觀點出發,成膜時間較佳為二分鐘以上,更佳為三分鐘以上。此外,從提高生產性的觀點出發,較佳為六十分鐘以下,更佳為三十分鐘以下,尤佳為10分鐘以下。 (實施例) >裝置>
利用圖2所顯示的成膜裝置,在樣本的內壁面上形成了類碳膜。腔室101是直徑200mm、長度500mm的不鏽鋼容器。腔室101上連接有真空排氣部110與氣體供給部115,電源部120由電壓生成器121(IWATSU製造 SG-4104)與放大器122(NF Corporation製造HVA4321)構成。放電電極125是直徑6mm、長度70mm的不鏽鋼電極。氣體供給部115構成為:從甲烷氣體高壓罐116經質量流量控制器117供給原料氣體。藉由控制閥的開啟度與氣體供給量調節了腔室110內的壓力。
>在人造血管上的成膜> 將內徑3mm、厚度0.35mm、長度150mm的ePTFE製人造血管(GORE-TEX公司製造、SGTW-0315BT)放入內徑4mm、長度150mm的矽軟管製外筒內,並按規定時間進行了成膜。
原料氣體為CH4 ,流量為96.2ccm(室溫),腔室內的壓力為39.06Pa。成膜之際的偏壓電壓為5kV,頻率為10kHz。間歇地施加了5分鐘的交流電壓,使脈衝重複頻率達到10pps或者30pps。需要說明的是,成膜之際,由放大器施加了2kV的偏壓電壓。
>微小表面粗糙度的測量> 用電解放射型掃描電子顯微鏡(日立High-Technologies公司、S-4800)拍攝了人造血管內壁面的照片,對該照片進行了圖像處理,由此計算出了微小表面粗糙度。首先,將倍率100K倍的電子顯微鏡照片的1290×960部分作為像素50×50的圖像取入電腦中。依據取入的各像素的輝度,計算各像素的相對高度值,並將該值作為像素值。接著,利用Trend filtering(參考Tibshirani, R.: Adaptive piecewise polynomial estimation via trend filtering, Annals of Statistics, 42(1), 285-323, 2014)去除了藉由計算獲得的像素值中含有的雜訊。根據去除了雜訊後的像素值,並運用下述式(1),計算出了用圖像分析獲得的微小算術平均粗糙度(IARa);運用下述式(2),計算出了用圖像分析獲得的微小均方根高度(IARq)。此外,n設定為2500,並且以50×50的所有像素為對象進行計算。還有,用上述計算獲得的IARa和IARq除以未處理的人造血管的IARa值和IARq值,並將計算獲得的數值分別當作標準化IARa和標準化IARq。 (式1)
Figure 02_image001
(式2)
Figure 02_image003
>吸附等溫線的測量> 將十根切割成長度為10mm的人造血管裝入樣本管中,就該樣本使用氣體吸附裝置(Microtrac-bel公司製造、BELSORP18),求出了水蒸氣吸脫附等溫線和氮氣吸脫附等溫線。為了進行脫氣,對樣本進行了預處理。預處理溫度為100℃。預處理時間為3小時至8小時,在充分進行了脫氣的狀態下讓預處理結束。關於水蒸氣,將吸附溫度設定為25℃;在0.4kPa至2.9kPa的壓力範圍內(相對壓力0.11至0.91),一邊提升壓力,一邊時間上基本等間隔地測量了二十個點的吸附量,然後,一邊降低壓力,一邊時間上基本等間隔地測量了十一個點的吸附量。將氮氣的吸附溫度設定為-196℃。在5.3kPa至101kPa的壓力範圍內(相對壓力0.05至1.0),一邊提升壓力,一邊時間上基本等間隔地測量了二十七個點的吸附量,然後,一邊降低壓力,一邊時間上基本等間隔地測量了十四個點的吸附量。
>接觸角的測量> 用接觸角測量儀(協和介面科學公司製造、DropMaster500),測量了形成有類碳膜且厚度為0.1mm的ePTFE薄膜表面相對於水的接觸角。水的滴下量設定為2μL。
>免疫細胞吸附量的測量> 對體重35kg的雄性山羊進行全身麻醉和肝素管理,並在其左右側頸部分別使用人造血管進行了Arterial-Venous(A-V)分流。人造血管的長度約為5cm。
在內服阿司匹林的管理條件下飼養山羊八週後,進行全身麻醉和肝素管理,與動靜脈一起摘除了左右的人造血管。使用生理食鹽水清洗摘除的血管後,使用10%福馬林進行固定,嵌入石蠟後製作成切片。製作的切片應能夠顯示出人造血管的橫截面剖面。對製作的切片進行Hematoxylin-Eosin(HE)染色後,在顯微鏡下測量免疫細胞的個數和人造血管的壁面的長度(血管長度),計算出了每1mm長的血管對免疫細胞的吸附量。對七個切片,測量了每1mm長的血管對免疫細胞的吸附量,並求出了其平均值。觀察時的倍率為一百倍。
(實施例1) 成膜時間設定為五分鐘,在人造血管的內壁形成了類碳膜。已形成有類碳膜的人造血管的表面狀態如圖6A所示。圖7A所示的SEM圖像的IARa為0.95,IARq為1.2。利用未處理的人造血管的IARa進行過標準化後的IARa為0.34,利用未處理的人造血管的IARq進行過標準化後的標準化IARq為0.32。水蒸氣吸附等溫線顯示了脫附遲滯現象(圖8A)。另一方面,氮氣吸附等溫線沒有顯示出脫附遲滯現象(圖9A)。此外,相對於水的接觸角為98°。將本實施例的人造血管置入山羊的左側頸部的結果,如圖10A所示,免疫細胞的吸附量較少,吸附量的平均值為三個/mm。
(比較例1) 沒有形成類碳膜的人造血管的表面狀態如圖7B所示。圖7B所示的SEM圖像的IARa為2.8,IARq為3.6。水蒸氣吸附等溫線和氮氣吸附等溫線都沒有顯示脫附遲滯現象(圖8B、圖9B)。此外,相對於水的接觸角為132°。將本比較例的人造血管置入山羊的右側頸部的結果,如圖10B所示,許多免疫細胞被人造血管的內壁面吸附,吸附量的平均值為二十九個/mm。
(比較例2) 除了成膜時間設定為1分鐘外,其它都與實施例1一樣,形成了類碳膜。形成有類碳膜的人造血管的表面狀態如圖7C所示。水蒸氣吸附等溫線和氮氣吸附等溫線都沒有顯示脫附遲滯現象。此外,相對於水的接觸角為107°。
水蒸氣吸附等溫線的脫附遲滯現象和相對於水的接觸角顯示,與未處理的人造血管和比較例2的人造血管相比,實施例1的形成了類碳膜的人造血管更具親水性。此外,表面的平滑性提高,從而能夠大幅度地降低對免疫細胞的吸附量。 (產業可利用性)
本發明的人造血管係內壁的微小凹凸較小,不易吸附免疫細胞,非常適合作為醫療用人造血管。
10:人造血管 11:類碳膜 12:人造血管主體 13:細孔 101:腔室 102:細長管 103:電極連接器 104:外筒 110:真空排氣部 112:真空泵 113:閥 115:氣體供給部 116:高壓罐 117:質量流量控制器 120:電源部 121:電壓生成器 122:放大器 125:放電電極 126:相對電極
圖1係顯示本發明之一實施形態之人造血管的剖面圖。 圖2係顯示人造血管製造裝置的示意圖。 圖3係顯示放電電極連接部分的剖面圖。 圖4係顯示放電電極連接部分的變形例的剖面圖。 圖5係顯示放電電極連接部分的變形例的剖面圖。 圖6係顯示相對電極的變形例的剖面圖。 圖7A係顯示實施例1的人造血管表面的電子顯微鏡照片。 圖7B係顯示比較例1的人造血管表面的電子顯微鏡照片。 圖7C係顯示比較例2的人造血管表面的電子顯微鏡照片。 圖8A係顯示實施例1的人造血管的水蒸氣吸附等溫線。 圖8B係顯示比較例1的人造血管的水蒸氣吸附等溫線。 圖9A係顯示實施例1的人造血管的氮氣吸附等溫線。 圖9B係顯示比較例1的人造血管的氮氣吸附等溫線。 圖10A係顯示實施例1的人造血管置入後之狀態的顯微鏡照片。 圖10B係顯示比較例1的人造血管置入後之狀態的顯微鏡照片。
10:人造血管
11:類碳膜
12:人造血管主體
13:細孔

Claims (9)

  1. 一種人造血管,係包括:人造血管主體、以及覆蓋前述人造血管主體之內壁的類碳膜,由前述類碳膜覆蓋的內壁係以水蒸氣吸附等溫線顯示脫附遲滯現象。
  2. 如請求項1所記載之人造血管,其中由前述類碳膜覆蓋的內壁係藉由圖像分析獲得的微小算術平均粗糙度為2.5以下。
  3. 如請求項2所記載之人造血管,其中在前述人造血管主體的兩端部和中間部,由前述類碳膜覆蓋的內壁的前述微小算術平均粗糙度為固定不變。
  4. 如請求項2所記載之人造血管,其中利用未被前述類碳膜覆蓋的內壁之前述微小算術平均粗糙度,對被前述類碳膜覆蓋的內壁之上述微小算術平均粗糙度進行了標準化,標準化後的標準化算術平均粗糙度為0.9以下。
  5. 如請求項1所記載之人造血管,其中由前述類碳膜覆蓋的內壁之相對於水的接觸角為105°以下。
  6. 如請求項1所記載之人造血管,其中由前述類碳膜覆蓋的內壁對免疫細胞的吸附量為二十個/mm以下
  7. 如請求項1至6中任一項所記載之人造血管,其中前述人造血管主體具有網眼狀的細孔; 前述類碳膜覆蓋了前述細孔內表面。
  8. 一種人造血管之製造方法,係包括:將多孔性的人造血管主體配置在能夠調整內部壓力的腔室內,在已供給了含烴的原料氣體的狀態下於前述人造血管主體的內部生成電漿,用類碳膜覆蓋前述人造血管主體的內壁之工序; 將前述人造血管主體收納於內徑比前述人造血管主體之外徑大的非導電性外筒內,並在該狀態下將前述人造血管主體配置在前述腔室內;將放電電極配置在前述外筒的一端部,讓前述外筒的另一端部處於開放狀態;將交流偏壓間歇地施加在前述放電電極和與前述外筒之間保持有距離的相對電極之間;由前述類碳膜覆蓋的內壁係以水蒸氣吸附等溫線顯示脫附遲滯現象。
  9. 一種人造血管之製造裝置,係包括: 能夠調整內部壓力的腔室;向前述腔室內供給烴氣體的氣體供給部;設置在前述腔室內的放電電極和相對電極;以及將交流電壓間歇地施加在前述放電電極和前述相對電極之間的電源部;將前述放電電極安裝在收納人造血管主體的外筒之一端部,將前述相對電極設置成與前述外筒保持有距離,且讓前述放電電極在該狀態下放電,藉此而在外筒內生成電漿,在前述人造血管主體的內壁形成類碳膜;由前述類碳膜覆蓋的內壁係以水蒸氣吸附等溫線顯示脫附遲滯現象。
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