TWI401097B - 強化之可吸收性多層止血傷口敷料及製造方法 - Google Patents

強化之可吸收性多層止血傷口敷料及製造方法 Download PDF

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TWI401097B
TWI401097B TW94136436A TW94136436A TWI401097B TW I401097 B TWI401097 B TW I401097B TW 94136436 A TW94136436 A TW 94136436A TW 94136436 A TW94136436 A TW 94136436A TW I401097 B TWI401097 B TW I401097B
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absorbable
woven
dressing
multilayer
fabric
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TW94136436A
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TW200630126A (en
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Anne Jessica Gorman
Sanyog Manohar Pendharkar
Guanghui Zhang
Lillian Bar
Israel Nur
Roberto Meidler
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Ethicon Inc
Omrix Biopharmaceutical Inc
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Description

強化之可吸收性多層止血傷口敷料及製造方法
本申請案聲明於2004年10月20日申請之美國臨時申請案序號60/620539及於2005年7月1日申請之美國臨時申請案序號60/696258之優先權。
發明領域
本發明係有關一種強化之可吸收性多層止血傷口敷料及製造方法。
 發明背景
在手術過程中，出血之控制及空氣和各種體液之密封為必須且重要的，為的是要減少血液損失、密封組織及器官構造、降低外科手術後併發症及縮短在手術室中之手術期間。
在提供具增進止血性及組織密封及附著特性之敷料的努力中，包括(但不限於)凝血酶、血纖維蛋白及血纖維蛋白原之治療劑已組合有敷料載劑或基材，包括以明膠為底之載劑、以多糖為底之載劑、以乙醇酸或乳酸為底之載劑及膠原蛋白基質。此等敷料之實例被揭示於USP 6,762,336、USP 6,733,774及PCT公開案WO2004/064878 A1中。
基於生物可分解性及殺菌性、組織密合、組織修復、藥物傳送及止血特性，理想的是使用已被氧化以包含羧酸部分之纖維素(下文稱為羧酸氧化之纖維素)作為在各種外科手術過程(包括神經手術、腹部手術心血管手術、胸膛手術、頭及頸部手術、骨盆手術及皮膚和皮下組織處理)中之局部敷料。
然而，當羧酸氧化之纖維素與凝血酶及血纖維蛋白原組合使用時，存在於纖維素中之酸性部分可使凝血酶及血纖維蛋白原之活性變質。因此，期望可使凝血酶及血纖維蛋白原避免此等酸部分以維持彼等之止血效果。
當被用於本文時，術語"非織物"包括(但不限於)黏合織物、非織物(formed fabric)或工程織物，其藉由紡絲、編織或針織以外之方法予以製造。尤特別地，術語"非織物"指的是有孔、似紡織之材料，通常為平坦片狀，主要或全部由被組合成網、片或絮墊之短纖維所組成之。非織物之結構為以例如短纖維之排列為主，其通常或多或少隨機排列。非織物之拉伸、應力－應變及觸感特性通常係由藉例如短纖維之纏結及強化所產生之纖維對纖維磨擦所造成及/或由黏著性、化學性或物理性黏合所造成。儘管如此，用以製造非織物之原料可為紗、條子稀洋紗(scrim)、網狀編結織物或藉包括紡絲、編織或針織之方法所製造之絲狀纖維。
 發明概述
本發明係有關一種強化之可吸收性多層止血傷口敷料，其包含藉第二可吸收性編織或針織織物予以強化之第一可吸收性非織物，及凝血酶及血纖維蛋白原；以及製造方法。尤特別地，第一可吸收性非織物包含纖維，其含有脂族聚酯聚合物、共聚物或其之摻合物；而第二可吸收性編織或針織織物包含氧化之再生纖維素纖維。
發明之詳細說明
本文所述之多層敷料當被塗覆至需要止血之傷口時，提供及維持有效之止血。當被用於本文時，有效之止血為在一段熟悉止血技藝者所認知之有效時間內，控制及/或減輕毛細管、靜脈或微動脈之出血。有效止血之進一步指標可藉政府規定標準等予以提供。
在某些具體實施例中，本發明之多層敷料對於在嚴重或快速出血之情況中提供及維持止血是有效的。當被用於本文時，嚴重之出血意指包括那些相當高血量在相當高速率下流失之出血情況。嚴重出血之實例包括(但不限於)因為動脈穿孔之出血、肝臟部分切除、鈍器肝損傷、鈍器脾損傷、主動脈動脈瘤之出血、來自過度抗凝血之病人的出血或來自具凝血病(諸如血友病)之病人之出血。
強化之可吸收性多層敷料通常包含一種非織物及一種強化織物。強化織物提供一種非織物可附著(直接或間接)之支撐物，其中凝血酶及血纖維蛋白原實質上均勻地分散在非織物中及/或被置於非織物之表面。強化織物提供敷料強度，足以允許敷料之使用者放置及處理敷料於傷口上或直接於需要止血、組織閉合及黏附之病人的組織上。
除了充作凝血酶及血纖維蛋白原之載體外，非織物亦用來避免凝血酶及血纖維蛋白原接觸可能存在於強化織物中之酸性部分，諸如在羧酸－氧化之纖維素被用作強化織物之情況中。
非織物係作為本文所述之強化可吸收性多層敷料之第一可吸收性非織物之用。第一可吸收性非織物係由包含脂族聚酯聚合物、共聚物或其之摻合物之纖維所組成。脂族聚酯通常係於單體(包括(但不限於)乳酸、交酯(包括L－、D－、消旋及D,L混合物)、乙醇酸、乙交酯、ε－己內酯、p－二噁酮(1,4－二噁－2－酮)及三亞甲基碳酸酯(1,3－二噁－2－酮))之閉環聚合中被合成。
較佳地，第一可吸收性非織物包含乙交酯及交酯之共聚物，用量為約70至95%(以莫耳為基準)之乙交酯，而其餘為交酯。
較佳地，非織物係藉除了紡織、編織或針織以外之方法所製造。例如，非織物可由已藉包括紡織、編織或針織之方法所製造之紗、條子稀洋紗、網狀編結織物或絲狀纖維予以製備。紗、條子稀洋紗、網狀編結織物及/或絲狀纖維被捲曲以促進互相纏結及附著至第二可吸收性編織或針織織物上。此種捲曲之紗、條子稀洋紗、網狀編結織物及/或絲狀纖維隨後可被切割成足以纏結之長度的短纖維。短纖維可介於約0.1和2.5英吋長之間，較佳介於約0.5和1.75英吋長之間，最佳介於約1.0和1.3英吋長之間。短纖維可被梳棉以產生非織的絮墊，其隨後可被針孔或輥壓成第一可吸收性非織物。此外，纖維可被扭結或堆積。
可使用之其他製造非織物之已知方法，包括諸如空氣佈層、濕法成形及針縫黏合之方法。此等程序通常被論述於聚合物科學及工程百科第10冊，第204－253頁(1987)及Albin Turbank之非織物介紹(Tappi Press，Atlanta GA 1999)，二者之全部內容併入本文作為參考。
非織物之厚度可由約0.25至2毫米。非織物之基重為約0.01至0.2克/平方英吋；較佳約0.03至0.1克/平方英吋；最佳約0.04至0.08克/平方英吋。第一可吸收性非織物之重量百分比基於具有凝血酶及血纖維蛋白原之強化可吸收性多層織物之總重量為準可介於約5至50百分比。
第二可吸收性編織或針織織物係作為強化織物之用且包含氧化多糖，特別是氧化纖維素及其之中和化衍生物。例如，纖維素可為羧酸－氧化或醛－氧化之纖維素。尤佳地，氧化之再生多糖(包括(但不限於)氧化之再生纖維素)可被用來製備第二可吸收性編織或針織織物。再生纖維素為較佳者係因之相對於未被再生之纖維素有較高度之均勻性所致。再生纖維素及如何製造氧化之再生纖維素之詳細描述被提供於USP 3,364,200、USP 5,180,398及USP 4,626,253中，各自被併入作為參考之內容猶如以整體被提出者。
可被用作強化織物之織物的實例包括(但不限於)Interceed可吸收性黏附阻隔物、Surgicel可吸收性止血劑；Surgicel Nu－knit可吸收性止血劑；及SurgicelFibrillar可吸收性止血劑；分別得自Johnson & Johnson創傷管理全球公司或婦科護理全球公司，分別為Ethicon股份有限公司之一分部(Somerville，紐澤西)。
用於本發明中之強化織物可被編織或針織，條件是織物具有供用於所思及應用中所需之物理特性。此等織物例如描述於USP 4,626,253，USP 5,002,551及USP 5,007,916，各自被併入作為參考之內容猶如以整體被提出者。
於一較佳具體例中，強化織物為由亮光紗所構成之特里科經編針織物(warp knitted tricot fabric)，其隨後被氧化以包括有效量之羧基及醛部分，以提供織物具生物可分解性。
於另一具體例中，強化織物已包含氧化多糖，組合有由脂族聚酯聚合物、共聚物或其之摻合物所組成之纖維。
第二可吸收性編織或針織織物較佳包含氧化之再生纖維素且可由具有基重由約0.001至0.2克/平方英吋，較佳約0.01至0.1克/平方英吋之範圍，最佳約0.04至0.07克/平方英吋之範圍。
第一可吸收性非織物被附著至第二可吸收性編織或針織織物(直接或間接)。例如，非織物經由針扎(needle－punching)、輥壓、壓花或水纏結，或化學性或熱黏合被組合於第二可吸收性編織或針織織物中。第一可吸收性非織物之短纖維可互相纏結及包埋於第二可吸收性編織或針織織物中。尤特別地，就除了化學及熱黏合以外之方法而言，第一可吸收性非織物可被附著於第二可吸收性編織或針織織物中，使至少約1%之第一可吸收性非織物之短纖維曝露於第二可吸收性編織或針織織物之另一面，較佳約10－20%，宜不大於約50%。此確使第一可吸收性非織物及第二可吸收性編織或針織織物中仍為結合的且在正常處理條件下不分層。強化之可吸收性多層織物為均勻的，使得實質上無第二可吸收性編織或針織織物明顯未被第一可吸收性非織物覆蓋。
一種製造本文所述之多層織物的方法為藉下列方法而成者。具有每纖維約1至4丹尼爾(denier)之可吸收性聚合物可被強固至約80至120丹尼爾多絲紗，然後至約800至1200丹尼爾紗，被熱捲曲及隨後被切割至具有長度約0.75及1.5英吋之間長度之短纖維。短纖維可被送入多滾筒梳纖成網(dry lay)梳理機一或多次，及被梳棉成均勻之非織絮墊，而濕度在60至75℃之室溫下被控制在介於約40－60%之間。例如，均勻非織絮墊可利用單一圓筒－上部梳理機(其具有被交替滾筒及抄棉輥所覆蓋之主圓筒，其中絮墊藉集棉滾筒自圓筒表面予以脫去，並蓄積在收集輥上)予以製造。絮墊可進一步藉針扎或任何其他方法(諸如輥壓)予以強固。之後，第一可吸收性非織物可藉諸如針扎之各種技術予以附著至第二可吸收性編織或針織織物上。強化之可吸收性多層織物隨後可藉在適當溶劑中清洗予以洗滌及在約30分鐘之適度環境下予以乾燥。
期望的是可控制製程參數，諸如短纖維長度、短纖維之開孔、短纖維進料速率及相對濕度。例如，強固之紗可具有每英吋約5至50個捲邊，較佳每英吋約10至30個捲邊。捲曲紗之有效切割為理想的，因為任何長且不完全切割之短纖維傾向於黏附在梳理機上且引起堆疊。短纖維長度之較佳範圍為約0.75至1.5英吋，較佳約1.0至1.3英吋。
為有最適均勻度及減少靜電之發生，相對濕度可在絮墊處理期間，較佳在梳理期間予以控制，以形成均勻之非織絮墊。較佳地，非織絮墊係利用一種梳纖成網梳理法，在至少約40%之相對濕度，約60至75℃之室溫下予以處理。尤佳地，非織絮墊在約50%至60%之相對濕度下予以處理。
多層織物利用適合溶解任何紡絲加工劑之溶劑予以洗滌。溶劑包括(但不限於)異丙醇、己烷、乙酸乙酯及二氯甲烷。多層織物隨後在提供充分乾燥，同時避免收縮之條件下被乾燥。
強化之可吸收性多層織物具有介於約0.75和3.0毫米之間，較佳約1.00和2.5毫米之間，最佳約1.2和2.0毫米之間的平均厚度。強化之可吸收性多層織物之基重為介於約0.05和0.25克/平方英吋之間，較佳介於約0.08和0.2克/平方英吋之間，最佳介於約0.1和0.18克/平方英吋之間。強化之可吸收性多層織物為均勻的，使得在各平方英吋間的基重或厚度有不超過約10%之變動(平均值之相對標準差)。
凝血酶及血纖維蛋白原可為動物來源，較佳為人類，或可為重組物。在多層敷料上之凝血酶活性可為約20至500 IU/平方公分之範圍，較佳約20至200 IU/平方公分，最佳約50至200 IU/平方公分。在多層敷料上之血纖維蛋白原活性可為約2至15毫克/平方公分之範圍，較佳約3至10毫克/平方公分，最佳約4至7毫克/平方公分。
具有凝血酶及血纖維蛋白原粉末之多層敷料之基重為介於0.1和1.0克/平方英吋之間，較佳介於0.1和0.5克/平方英吋之間，最佳介於0.1和0.3克/平方英吋之間。具有凝血酶及血纖維蛋白原粉末之多層敷料例如可藉輻射，較佳藉電子束輻射，予以殺菌。
具有凝血酶及血纖維蛋白原粉末之多層敷料之孔隙度為約50－250立方公分/秒/平方公分，較佳介於50－150立方公分/秒/平方公分之間，最佳為50－100立方公分/秒/平方公分。
當強化之可吸收性多層纖維於內部使用時，其質量之約50至75%於2週後被吸收。質量損失之百分比可利用大鼠移植模型予以測量。此時，首先在大鼠之腰薦脊柱上之皮膚做一中線切口(約4公分)而將織物插入大鼠體內。隨後將兩邊皮膚與下面的結締組織分離以裸露淺層臀部肌肉。然後在背外側筋膜上做一切口(其位在臀部肌肉上方且直接鄰近於脊柱)。利用鈍器解剖，在筋膜及橫向於切口之臀部肌肉之間產生一小袋。將多層纖維放在臀袋中。於原處縫合筋膜。於兩週後，使大鼠安樂死，並將多層織物植出，以測量經過兩週期間之質量損失百分比。
第一可吸收性非織物保留未分離之固體凝血酶及固體血纖維蛋白原粉末，且自其表面有最小粉末損失。將包含溶液之凝血酶及血纖維蛋白原分別凍乾。然後將凍乾之物質利用超細研磨機或冷卻葉片研磨機予以磨成粉。將粉末稱重並一起懸浮於承載液體中，其中蛋白質不可溶。較佳之承載液體為全氟化碳氫化物，包括(但不限於)HFE 7000，HFE 7001、HFE 7003及PF 50/60(商場上可得自明尼蘇達州之3M公司)。可使用任何其他蛋白質不溶之承載液體，諸如醇類、醚類或其他有機液體。將懸浮液充分混合並藉由傳統方法，諸如濕式、乾式或靜電噴霧、浸漬塗覆、塗漆或噴灌，予以塗覆至第一可吸收性非織物上，同時維持在約60至75℉之室溫及約10至45%之相對濕度下。然後將經塗覆之多層織物在周圍室溫下乾燥並包裝於一適當之防水容器中。具有凝血酶及血纖維蛋白原之多層織物包含不超過25%之水分，較佳不超過15%之水分，最佳不超過5%之水分。
被塗覆至非織物之凝血酶及血纖維蛋白原之量為足以覆蓋其表面，使得無一區域明顯未覆蓋。粉末可大部分留置於非織物之上或可滲透於非織物內，直達第二可吸收性編織或針織織物之表面。然而，大部分之粉末不會接觸第二可吸收性編織或針織織物，且只有少量之粉末滲透至第二可吸收性編織或針織織物之底面。
作為一外科手術之敷料，本文所述之多層敷料可被用作一種初生傷口閉合裝置(諸如動脈閉合裝置、鎖環、縫合線)之佐劑，以密封氣體、液體或固體之可能滲漏以及提供止血。例如，多層敷料可被用來密封來自組織之氣體，或來自器官及組織之液體，包括(但不限於)膽汁，淋巴液、腦脊髓液、胃腸液、間隙液及尿液。
本文所述之多層敷料具有其他醫學應用且可用於各種臨床功能，包括(但不限於)組織強化及支撐，亦即供胃腸或血管之吻合、接近(即連接難以進行(亦即在張力下)之吻合)及張力釋放。在所有上述情況中，敷料可額外增進且可促進天然組織癒合過程。此種敷料可在許多類型手術中供內部使用，包括(但不限於)心血管、周邊血管、心臟－胸廓、婦科、神經及一般外科手術。敷料亦可被用來使醫學裝置(例如網、夾及膜)附著於組織、使組織附著於組織或使醫學裝置附著於醫學裝置。
 實施例1.
聚(乙交酯－共－交酯)(PGL，90/0莫耳/莫耳)熔紡成纖維。將80丹尼爾之多絲紗強固為800丹尼爾之多絲紗。在約110℃下捲曲強固之紗。將捲曲紗切割成具有長度約1.25”長之短纖維。將20克捲曲短纖維正確稱重並均勻鋪疊在多滾筒梳理機之進料輸送帶上。控制環境條件(溫度：70℉/55%RH)然後將短纖維梳理以產生非織絮墊。自撿拾滾筒移除絮墊並切割成4平方部份。將彼等重新送入垂直於收集方向之梳理機中。於第二次通過之後，將絮墊稱重(19.8克：99%織物產量)，然後予以壓縮成毛氈。將壓縮毛氈準確地鋪疊在ORC織物上，並在針扎設備中，經由2次通過予以穩固地附著。將多層織物修剪並以3次不連續異丙醇浴予以洗滌，以去除紡絲加工劑及任何之機械油。在70℃之烘箱中乾燥經洗滌之多層織物30分鐘，予以冷卻及稱重。
將18.93克之BAC－2[(Omrix Biopharmaceuticals公司)比活性(以高斯(Clauss)計)0.3克/克]及1.89克凝血酶與約420毫升之HFE7000充分混合。經由一噴嘴將料漿噴灑於重約12克，大小8”X12”之多層織物上。將多層止血傷口敷料風乾約30分鐘。在整個過程中，環境條件維持在75℉/45% RH。將多層止血傷口敷料切割成適當大小並裝入盒中。盒被特別設計成使盒之頂部和底部間之間隙稍低於敷料之整體厚度，以確保在運送及處理期間有最小之移動。將盒進一步包裝於鋁箔軟袋中，其視需要與乾燥劑一起被熱封。將敷料貯存在2－8℃，直到需要時。
多層織物/敷料之"厚度"如本文所述予以測量。測量工具為：(1)Mitutoyo Absolute尺規型號ID－C125EB[代號－－543－452B]。1”直徑壓腳被用在量規上。
(2)使用一磁性支架來鎖住固定並安裝卡箝至模具定模板上。
(3)兩個金屬板~2.75”x 2”x 0.60”，重量介於40.8克至41.5克之間[總計~82.18克]。
將多層織物放在一為平坦和機製表面之定模板表面上。將兩個金屬板以頂部互底地放在多層織物上並小心地壓住諸角以確保多層織物平坦。將量規壓腳放在金屬板頂部，然後予以再升起及再放下，此時產生讀值。
實施例2
通常，將麻醉之小豬解剖以露出腹部主動脈。生檢穿孔器被用來去除4毫米主動脈之切片。使血液自由流動，並將待試驗之敷料迅速塗抹至傷口部位，同時吸出任何過量匯流的血液。施加手壓以維持敷料在傷口位置上3分鐘。在約三分鐘時，去除壓力。若敷料良好黏附至傷口且達到完全止血，而無再流血者，則試驗被認為是"通過"。
實施例2
通常，將麻醉之小豬解剖以露出腹部主動脈。生檢穿孔器被用來去除4毫米主動脈之切片。使血液自由流動，並將待試驗之敷料迅速塗抹至傷口部位，同時吸出任何過量成灘之血。施加手壓以維持敷料在傷口位置上3分鐘。在約三分鐘時，去除壓力。若敷料良好黏附至傷口且達到完全止血，而無再流血者，則試驗被認為是"通過"。
所有之動物在試驗結束後予以安樂死，但樣本ID46及47除外，彼等在手術後存活至少2週。
實施例3 具ORC背層之非織PGL纖維素墊
將聚(乙交酯－共－交酯)(PGL，90/10莫耳/莫耳)熔紡成纖維。將纖維切割成小的短纖維，然後予以梳理以產生約1.25毫米厚及約98.1毫克/cc之極細非織基材。然後將非織基材針扎於針織之羧酸－氧化之再生纖維素纖維(可得自Ethicon公司之商品Interceed)上以牢固非織基材於ORC纖維上。最終構造物包含約60重量百分比之非織纖維。
實施例4 塗覆有血纖維蛋白原和凝血酶之基質樣本之黏著劑/密封劑特性之分析
以主要由血纖維蛋白原(7至8毫克/平方公分)和凝血酶(50 IU/平方公分)所組成之乾燥顆粒塗覆描述於實施例3中之材料，然後利用一種液壓破裂滲漏試驗(HBLT)予以試驗。將塗覆材料之樣本切割成3/4英吋直徑之圓片。將樣本放在衍生自小牛心包之組織基質中，在組織中央具有一小洞。將刺穿之組織基質放入氣密室中，室中唧入食鹽水。測量瓦解/破裂在組織和塗覆樣本間所形成密封所需之壓力(見圖1)。無蛋白質塗覆物之樣本不會附著至組織。
雖然實施例說明本發明之某些具體例，彼等並未被解釋為限制本發明之範疇，而是有助於本發明之完整描述。以下實施例所述之所有強化織物為依彼等商品名所指之對應商品之預殺菌材料。
 圖式之簡要說明
圖1顯示瓦解/破裂在組織及止血傷口敷料間所形成密封所需要之壓力。

Claims (26)

  1. 一種多層傷口敷料，其包含第一可吸收性非織物、第二可吸收性編織或針織織物、凝血酶及血纖維蛋白原，其中第一可吸收性非織物包含乙交酯/交酯共聚物，第二可吸收性編織或針織織物包含氧化之纖維素。
  2. 根據申請專利範圍第1項之多層敷料，其中第一可吸收性非織物包含纖維，係由脂族聚酯聚合物或一或多種選自由乳酸、交酯(包括L-、D-、消旋及D,L混合物)、乙醇酸、乙交酯、ε-己內酯、p-二噁酮及三亞甲基碳酸酯所成組群中之單體的共聚物所組成。
  3. 根據申請專利範圍第1項之多層敷料，其中第二可吸收性編織或針織織物包含氧化之再生纖維素。
  4. 根據申請專利範圍第1項之多層敷料，其中第二可吸收性編織或針織織物為一種包含氧化之再生纖維素之可吸收性針織織物。
  5. 根據申請專利範圍第1項之多層敷料，其中第一可吸收性非織物包含乙交酯/交酯共聚物，且第二可吸收性編織或針織織物包含氧化之再生纖維素。
  6. 根據申請專利範圍第5項之多層敷料，其中第一可吸收性非織物包含具有長度約0.75至1.5英吋之短纖維。
  7. 根據申請專利範圍第6項之多層敷料，其中短纖維被捲曲。
  8. 根據申請專利範圍第5項之多層敷料，其中第一可吸收 性非織物包含具有長度約1.0至1.3英吋之短纖維。
  9. 根據申請專利範圍第8項之多層敷料，其中短纖維被捲曲。
  10. 根據申請專利範圍第5項之多層敷料，其中第一可吸收性非織物包含以莫耳基準約70至95%之聚乙交酯及其餘之聚交酯，第二可吸收性編織或針織織物包含氧化之再生纖維素。
  11. 根據申請專利範圍第8項之多層敷料，其中短纖維係衍生自每絲約1至4丹尼爾之纖維。
  12. 根據申請專利範圍第11項之多層敷料，其中第一可吸收性非織物具有約0.01至0.2克/平方英吋之基重；第二可吸收性編織或針織織物具有約0.001至0.2克/平方英吋之基重；具有凝血酶及血纖維蛋白原於其中之多層敷料具有約0.1至1.0克/平方英吋之基重。
  13. 根據申請專利範圍第5項之多層敷料，其中在多層敷料上之凝血酶活性為約20至500 IU/平方公分，在多層敷料上之血纖維蛋白原活性為約2至15毫克/平方公分。
  14. 一種多層敷料，包含一具有長度約0.75至1.5英吋之包含乙交酯/交酯共聚物短纖維之第一可吸收性非織物、一包含氧化之再生纖維素之第二可吸收性編織或針織織物、凝血酶及血纖維蛋白原；其中乙交酯/交酯共聚物包含以莫耳基準約70至95%之聚乙交酯及其餘之聚交酯，在多層敷料上之凝血酶活性為約20至500 IU/平 方公分，在多層敷料上之血纖維蛋白原活性為約2至15毫克/平方公分，及敷料之約50至75質量百分比在約14天後可被吸收。
  15. 一種製造如申請專利範圍第1項之多層傷口敷料之方法，其包含可吸收性非織物、凝血酶及/或血纖維蛋白酶原，其包含步驟：(a)將凝血酶及/或血纖維蛋白酶原懸浮於全氟化碳氫化物中，形成一懸浮液；及(b)將該懸浮液塗覆於該第一可吸收性非織物上。
  16. 根據申請專利範圍第15項之方法，其中該懸浮液係藉由濕式、乾式或靜電噴霧、浸漬塗覆、塗漆或噴灌而塗覆至該可吸收性非織物上。
  17. 一種製造如申請專利範圍第1項之多層傷口敷料之方法，其具有第一可吸收性非織物、第二可吸收性編織或針織織物、凝血酶及血纖維蛋白原，其中第一可吸收性非織物包含乙交酯/交酯共聚物，第二可吸收性編織或針織織物包含氧化之纖維素，包含步驟：(a)捲曲可吸收性聚合物纖維或紗在每英吋約10至30個捲邊之範圍；(b)切割捲曲纖維或紗至短纖維長度介於約0.1至2.5英吋之間；(c)梳理短纖維以形成第一可吸收性非織物，同時在約60至75℃之室溫下控制濕度至約40至60%；(d)黏附第一可吸收性非織物至第二可吸收性編織或 針織織物上；(e)塗覆凝血酶及血纖維蛋白原至第一可吸收性非織物上。
  18. 根據申請專利範圍第17項之方法，其中第二可吸收性編織或針織織物包含氧化之再生纖維素。
  19. 根據申請專利範圍第17項之方法，其中第二可吸收性編織或針織織物為一種包含氧化之再生纖維素之可吸收性針織織物。
  20. 根據申請專利範圍第17項之方法，其中第一可吸收性非織物包含乙交酯/交酯共聚物，且第二可吸收性編織或針織織物包含氧化之再生纖維素。
  21. 根據申請專利範圍第20項之方法，其中第一可吸收性非織物包含具有長度約0.75至1.5吋之短纖維。
  22. 根據申請專利範圍第20項之方法，其中第一可吸收性非織物包含具有長度約1.0至1.3吋之短纖維。
  23. 根據申請專利範圍第20項之方法，其中第一可吸收性非織物包含乙交酯及交酯之共聚物，用量為以莫耳基準約70至95%之乙交酯及其餘為交酯，第二可吸收性編織或針織織物包含氧化之再生纖維素。
  24. 根據申請專利範圍第23項之方法，其中短纖維係衍生自每絲約1至4丹尼爾之纖維。
  25. 根據申請專利範圍第20項之方法，其中第一可吸收性非織物具有約0.01至0.2克/平方英吋之基重；第二可吸收性編織或針織織物具有約0.001至0.2克/平方英吋 之基重；具有凝血酶及血纖維蛋白原於其中之多層敷料具有約0.1至1.0克/平方英吋之基重。
  26. 根據申請專利範圍第20項之方法，其中在多層敷料上之凝血酶活性為約20至500 IU/平方公分，在多層敷料上之血纖維蛋白原活性為約2至15毫克/平方公分。
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