1252112 玫、發明說明 [發明所屬之技術領域] 本發明係關於由具有生物活性（bio active)且可生物降解/ 吸收的有機-無機複合多孔體所構成之植入材料及其製造 方法，以及由此複合多孔體與其他活體材料所構成之植入 材料。 [先前技術] 作爲以醫療用途爲目的之無機多孔體，已知有例如將生 物陶瓷（bioceramics)試燒或燒結所得之多孔性陶瓷。然 而，此多孔性陶瓷係於使用於活體骨組織重建用的植基構 造或綴補材等之用途時，雖硬但脆爲其缺點，故於手術後 經常要擔心因爲稍微的衝擊所造成的破壞。又，於手術當 時將多孔性陶瓷的形狀以吻合活體骨組織的缺損部份之方 式來加工與變形亦甚困難。再者，欲完全替換活體骨，有 時須要長達1 0年以上的漫長期間，因此在該期間內仍有因 破壞所致的危害性的顧慮存在。 另一方面，作爲以醫療用途爲目的之有機多孔體，已知 有例如日本專利特公昭63 - 649 8 8號公報中所揭示之海綿 等。此海綿係通常於手術時的止血或活體軟組織（例如內臟 等）的縫合時，使用作爲綴補材料，故爲由活體內可生物降 解/吸收的聚乳酸所構成之有連續氣孔的海綿。此海綿係經 由使聚乳酸溶解於苯或二呤烷中，將該聚合物溶液凍結乾 燥，使溶劑昇華的方法來製造。 然而，經由上述海綿般的凍結乾燥法所製造的多孔體， 6 326\總檔\91 \91134292\91134292(替換)-2 1252112 須長時間的昇華以完全除去溶劑係屬困難，而其厚度薄至 lmm以下（通常爲數百// m程度），欲製造具數mm以上厚 度的多孔體，於現況上係屬困難。作爲製造具有連續氣孔 之多孔體的其他方法，於上述的凍結乾燥法之外，亦檢討 有各種方法，但欲製得具數mm以上厚度的多孔體皆非容 易。將此類薄的多孔體形狀吻合地補綴於活體組織損傷部 位之複雜且較大的三維空間上，固可發揮作爲暫時性的補 綴材之功能，然而，欲作爲謀求損傷部位的立體組織之再 建的材料則不可行。因此，期望厚度較厚且可於手術前或 手術中精細加工成任意形狀的三維立體形狀之能夠比較快 速地被分解吸收以代替活體骨者。 又，作爲製作連續多孔體的另一有效的方法，已知有混 合多量的水溶性之既定大小的NaCl等之可溶性的粉狀顆 粒於聚合物中，作成爲片狀等之薄狀成形體後，浸漬到水 (溶劑）中使該粉狀顆粒溶出，藉此以形成與該粉狀顆粒具 有同樣孔徑的連續孔的溶出法，但是，因難以將該粉狀顆 粒完全溶出，故僅限定於薄片的連續多孔體。又，若水溶 性的粉狀顆粒之比例不夠高，則不易生成連續氣泡。而且， 於將此多孔體埋入活體內之時，有煩惱殘留下之該粉狀顆 粒的毒性之問題。 如上述的海綿般，未含有具生物活性之生物陶瓷等之無 機粉狀顆粒的多孔體，由於缺乏與硬骨或軟骨等的活體骨 組織間的直接的結合性、傳導性、取代性等，故係非骨芽 細胞之纖維母細胞（fibroblast)等之侵入與介在，因此，欲 326\總檔\91\91134292\91134292(替換)-2 1252112 完全取代活體組織直到再生，須要相當的長期間，甚至未 能取代。 因此，本案申請人過去曾提出有：可播種骨芽細胞作成 爲三維立方體的植基構造，用以在大的骨缺損部位作爲橋 樑而植入之由在內部含有具生物活性之生物陶瓷粉狀顆粒 之活體內可生物降解/吸收之聚合物所構成的具有連續氣 孔之厚度大的多孔體之申請案（日本專利特願平8-229280 號）。 此多孔體係藉由稱爲溶液沉澱法的多孔體之製造方法 所製得者。亦即，將活體內可生物降解/吸收之聚合物溶解 於其溶劑與較其溶劑具高沸點的非溶劑所形成的混合溶劑 中’並使生物陶瓷粉狀顆粒分散調製成懸浮液，自此懸浮 液將混合溶劑依較溶劑的沸點低溫下使其揮發，使包裹著 生物陶瓷粉狀顆粒之活體內可生物降解/吸收之聚合物沈 澱的方法。 利用該溶液沉澱法之多孔體的形成原理，係如下所述。 亦即，自上述懸浮液將混合溶劑依較溶劑的沸點低溫下使 其揮發，則沸點低的溶劑會優先揮發，而沸點高的非溶劑 之比例會逐漸上昇，當溶劑與非溶劑達到一定的比例時， 溶劑即無法再將聚合物溶解。因此，聚合物開始析出.沈 澱，將最初即開始沈降的生物陶瓷粉狀顆粒包裹起來，析 出·沈澱之聚合物因爲高比例的非溶劑而收縮、固化，而 在含有生物陶瓷粉狀顆粒之狀態下被固定化，形成以連結 的聚合物之薄的胞（cell)壁將混合溶劑包住的狀態之胞狀 8 326\總檔\91\91134292\91134292(替換)-2 1252112 構造。其後，殘存的溶劑於將胞壁破壞之狀態下，作出氣 孔而揮發·消失，沸點高的非溶劑亦透過該氣孔慢慢地揮 發掉’終至完全地揮發·消失。其結果係被聚合物的胞壁 所包住之混合溶劑的殘跡成爲連續氣孔，形成含有生物陶 瓷粉狀顆粒之多孔體。 上述的溶液沉澱法，係用以形成自低發泡倍率至高發泡 倍率的具厚度的多孔體之絕佳方法，可製得具有由數mm 乃至於數十mm的厚度之塊狀三維多孔體。因此，於作成 有大起伏之立體形狀（三維立體構造）的骨再生的植基構造 等係頗爲有用。 然而，此方法的缺點在於：含有大量的生物陶瓷粉狀顆 粒之懸浮液中，屬於粒徑分布中之較大粒徑之生物陶瓷粉 狀顆粒，在溶劑開始揮發之最初即開始沈降，於聚合物開 始析出·沈澱時，已經有甚多的生物陶瓷粉狀顆粒朝向底 部沈降而帶有濃度梯度，故得到之多孔體係無法避免生物 陶瓷粉狀顆粒的含有量並非整體均一，自多孔體的上面側 愈往底面側其含有量愈多。這樣的帶有濃度梯度之不均一 含有量的多孔體，係對於骨組織重建用的植基構造、補綴 材料或骨塡料等之用途，並非一律有效而難以使用。此問 題係經由某種方法以設法控制生物陶瓷粉狀顆粒的沈降速 度，故可有某種程度之改善，卻無法完全解決。尤其是製 作含有30重量％以上的生物陶瓷粉狀顆粒的均質且有均等 的濃度之三維骨重建用的多孔體，並非只限於本方法，一 般而言均屬困難。 9 326\總檔\91 \91134292\91134292(替換)-2 1252112 以上述方法製造之生物陶瓷粉狀顆粒的含有量少的多 孔體’係生物陶瓷粉狀顆粒的大半被聚合物的胞壁所包 住，而難以露出到連續氣孔的內面或多孔體的表面，故於 埋入活體內時，難以於埋入後立即發揮因生物陶瓷粉狀顆 粒而有的活體骨組織之傳導作用，而有須待用以形成表皮 層之聚合物的分解而露出，於時間落後之下才發揮生物活 性之問題。 再者，以上述方法製造的多孔體，即使選擇極細的粉狀 顆粒作爲生物陶瓷粉狀顆粒，其含有率也不過約爲3 0重量 %之程度，若較此更多量地含有，則生物陶瓷粉狀顆粒會 更容易沈降，故得到之多孔體的底面側會含有多量的生物 陶瓷粉狀顆粒，而變得極脆。 又，以上述方法所製造之多孔體，通常，連續氣孔所佔 的比例雖高達80%以上，但一般而言，孔徑方面卻只能得 到數// m乃至數十// m之相對較小的連續氣孔，因此，難 以肯定說是形成對往多孔體內部之骨芽細胞之侵入與生長 而言爲理想的孔徑、孔的形態。 經由與上述本案申請人的溶液沉澱法相異的方法，亦檢 討有使無機粉狀顆粒物進行高塡充的方法，其中之有用的 方法之一，爲聚合物中塡充有50重量％左右的生物陶瓷粉 狀顆粒之顆粒製作，藉由將此粒子加熱使其在表面融合之 燒結方法來製得連續多孔體的方法。此方法並非新的方 法，係已知之於例如作爲環氧樹脂、氯乙烯樹脂等顆粒狀 樹脂的多孔體之製作方法。此方法係由於必須要表面融 10 326\總檔\91 \91134292\91134292(替換)-2 1252112 合，故塡充量有其界限，由於50重量％以上的塡充會變脆， 故困難，且氣孔徑的控制也非容易，品質上亦難以得到良 好者。 本發明之目的在於提供可完全解決此等問題之由無機 粒子高塡充的有機-無機複合多孔體所構成的各種植入材 料及其製造方法。並且，爲由此有機-無機複合多孔體與其 他活體材料的組合所構成之植入材料；而其目的在於提供 作爲骨固定材使用者、作爲脊椎固定材（椎間設置材、椎體 補強材）等使用者、作爲同種移植骨片或自身移植骨片、皮 質骨、海綿骨或其組合的替代物使用者、作爲骨缺損部分 或變形部分的綴補·塡充材等使用者、作爲用以形成硬· 軟骨的植基構造使用者、作爲人造軟骨使用者。 現今，作爲骨固定材，有於例如在胸骨正中切開閉鎖的 手術中，使用在胸骨的切開部兩側的髓內作爲架橋埋入之 由活體內可生物降解/吸收之聚合物所構成之固定軸釘。此 係在胸骨內會慢慢地分解而被吸收，故有不若非吸收性的 陶瓷或金屬製的軸釘般須再進行手術將其取出體外之優 點’但由於沒有骨傳導性且不會與骨組織直接結合，而僅 能發揮作爲楔子的作用，只具有將經閉鎖的胸骨暫時固定 而將切開面閉鎖的效用。因此，如同老人的胸骨的大半所 看到的’只殘留有海綿骨成爲只殘留有薄的皮質骨而變爲 薄板狀而變脆的情況下，即使將此胸骨用固定軸釘埋入， 欲充分發揮作爲「楔子」的作用以提高固定安定性亦有困 難，且殘留有也不會代替骨組織之問題。另一方面，胸骨 11 326\總檔\91 \91134292\91134292(替換)-2 1252112 以外的斷骨部位或骨折部位的接合固定所使用之羥磷灰石 (HA)等之陶瓷多孔體係有易裂開，且在活體內要被吸收須 極長時間之問題。也有見解認爲即使須長時間，但只要一 旦埋入活體骨中，強度即可恢復而不成問題，但至全部埋 入之期間的破損終究有其顧慮。本發明之作爲骨固定材所 使用之植入材料，係謀求解決此等問題者。 然而，向來的椎體固定材，例如，在對於腰椎病變性疾 病之前方椎體間固定術中作爲椎體間之間隔物使用之鈦製 或碳製的護架（cage)，雖可滿足表面的化學活體親和性， 但於力學上的活體親和性係異於活體，故作爲異物長期殘 存之下，會有經過時日的破壞及腐蝕導致發生對周圍組織 具危害性的顧慮之問題。亦有例如護架與活體的力學特性 之不一致所致而產生之，經過藉擴孔（reaming)而暴露的骨 性終板（end-plate)，護架會往椎體內沈降的問題。尤其是 碳製的護架，雖硬且脆，故會沿著碳纖維破壞，有時甚至 會產生碎片，故因其導致之危害性的發生之顧慮一直都存 在著。又，塡充於此等護架的移植用自身骨，通常係由腸 骨擷取來供應，有其數量的獲得、及擷取後的處理之繁雜 (經擷取之部位的後處理及腸骨之粉碎、對護架之塡充、無 菌下的處置等）之問題。本發明之作爲椎體固定材等使用之 植入材料，主要係謀求解決此等問題者。 另一方面，使用將死者之骨切斷、加工之同種移植骨 片、或自骨盤及肋骨等較大的骨部位擷取自身移植骨片來 塡補骨缺部位的手術係日常所進彳了者。同種移植骨片係 12 326\總檔\91 \91134292\91134292(替換)-2 1252112 只要是在海綿骨的表面具有皮質骨之已一體化的塊狀者， 即可將骨缺損部位的皮質骨部分以該骨片的皮質骨塡補， 將骨缺損部位的海綿骨部分以該骨片的海綿骨塡補。然 而，同種移植骨片，由於係將死者之骨切斷、加工者，故 須大量獲得作爲原料的死者之骨，而有提供充分移植骨片 並非容易之問題，且可加工的形狀也有莫大限制之問題。 又，雖說是同種移植骨片，但經移植的骨片畢竟是與本身 的骨組織爲相異的骨組織，基於埋入條件，或有因自然吸 收而消滅、或有強度不足或降低的顧慮。此外，由於係他 人的屍骨故殺菌處理是必要的，基於處理條件，屍骨會發 生改質，故充分的殺菌條件之控制是必要的。然而，時或 處理不充分，於埋入後至死亡之間亦有發生嚴重的事故的 情事。於手術中所擷取之自己的移植骨片，雖可避免此種 事故的發生，但不可否認其數量之不足。另一方面，亦進 行有將羥磷灰石（HA)、磷酸三鈣（TCP)等陶瓷製的植入材料 埋設於骨缺損部位，但此情況係有骨缺損部位的皮質骨部 分與海綿骨部分皆以一樣硬的陶瓷來塡補之問題，而且， 由於此陶瓷會半永久性地殘存著，故有骨缺損部位無法用 本身的骨組織重建之問題。因此，製作多孔質的該陶瓷以 代替海綿骨的方法變得相當實用。然而，理想上係用此等 合成人造骨來取代活體骨是最佳的，由於須10〜20年後的 長期間來進行取代，因此必需注意其間之作爲物理性的異 物之事故。本發明之作爲同種移植骨片及自身移植骨片的 代替物所使用之植入材料，主要係謀求解決此等問題者。 13 326\總檔\91 \91134292\91134292(替換)-2 1252112 再者，作爲習知的骨缺損部位或變形部位的補綴·塡 充·被覆材，係使用著藉由衝孔（punching)形成有多數孔之 金太等金屬製的衝孔（網眼狀）板、或經燒結之生物陶瓷的緻 密體或多孔體所構成之經穿孔的平板或凹凸板等。然而， 金屬製之衝孔板缺乏物理性的活體親和性，於塡補部位會 作爲異物而永久殘留，故於長期埋入中有腐蝕或金屬離子 的溶出等對周圍的組織具危害性的顧慮，並有永遠無法使 缺損部位經由骨組織來完全取代之問題。而且，燒結生物 陶瓷的多孔體雖硬卻脆而容易裂開，使用中受到衝擊會有 破壞之顧慮，有無法依骨缺損部位的立體形狀在手術中進 行後成形之問題。作爲本發明之補綴·塡充·被覆材使用 之植入材料，係謀求解決此等問題者。 又，習知之人造軟骨之如臨床上試用的全取代型之自主 性人造椎間板，係在活體非活性的聚乙烯或具有活體適合 性的橡膠所構成之芯的兩側（上下），疊合有鈦或鈷-鉻製的 2片金屬的終板，即所謂三明治構造的人造椎間板，芯部 分在2片聚乙烯之疊合狀態下，作成近似於活體椎間板的 動作，於橡膠的情況，則因其彈性而可進行模仿。而且， 於插入椎間時可防止脫落，爲了賦予自主性的效果，於金 屬板的表面使其突出數個角，其係作成爲以突刺於椎體的 凹面的方式而固定的構造。然而，此人造椎間板由於係與 活體的椎間板爲相異材料之三明治構造，故於反覆動作之 間，於界面處會發生摩擦，而不能說其動作與活體椎間板 相同，又，自金屬板突出的角，於會傷及上下椎體之同時， 14 326\總檔\91 \91134292\91134292(替換)-2 1252112 在長期使用下會慢慢地沈下到椎體中，有侵入而導致更大 的害處等重大缺點，無法與上下的椎體直接結合而自立、 固定。本發明之人造軟骨用之植入材料，主要係謀求解決 此等問題者’其目的在於藉由在與終板或椎體之間，隔有 本發明之多孔體，可將該人造椎間板之間的物理間隙塡埋 使其密合’並且經由骨傳導性可與椎體間直接結合。 [發明內容] 本發明之最基本的植入材料，係在活體內可生物降解/ 吸收之聚合物中均一分散著具生物活性之生物陶瓷粉狀顆 粒之具生物活性之活體內可生物降解/吸收的多孔體，其係 構成爲具有連續氣孔，且於氣孔內面或氣孔內面與多孔體 表面露出有部分的生物陶瓷粉狀顆粒的有機-無機複合多 孔體。此多孔體係如後所述，氣孔率爲5 〇〜9 0 %，連續氣孔 佔氣孔整體的50〜90%，此連續氣孔係作成爲適合骨芽細胞 之侵入而增殖、安定化所須之1 〇 〇〜4 〇 〇 # m的孔徑。且， 含有多量生物陶瓷粉狀顆粒達6 0〜9 0重量％，多孔體的厚 度大至1〜5 0mm，且具有三維立體形狀。此基本的植入材 料，可使用於各種醫療用途之如取代型骨組織再生用的植 基構造、補綴·被覆材、骨塡料、海綿骨的代替物、骨組 織與其他人造植入材料間的介在物、藥劑的載體等。 又，在活體內可生物降解/吸收之聚合物中均一分散著具 生物活性之生物陶瓷粉狀顆粒之具生物活性之活體內可生 物降解/吸收的多孔體’其係構成爲具有連續氣孔，且生物 陶瓷粉狀顆粒的含有率爲6 0〜9 0重量％的有機-無機複合多 15 326\總檔\91\91134292\91134292(替換)-2 1252112 孔體所形成之植入材料，亦爲本發明之基本的植入材料， 可使用於與上述相同的各種醫療用途中。 上述由有機-無機複合多孔體所構成之植入材料，可經由 本發明之製造方法來製造，亦即，於揮發性溶劑中，使活 體內可生物降解/吸收之聚合物溶解，使具生物活性之生物 陶瓷粉狀顆粒分散，調製成混合液，由該混合液作成不織 布狀的纖維集合體，將其在加熱下加壓成形，作成多孔質 的纖維集合成形體，然後將纖維集合成形體浸漬於揮發性 溶劑中’之後再將該溶劑除去的方法。 另一方面’應用上述有機-無機複合多孔體之本發明之植 入材料’係將上述有機-無機複合多孔體與其他質地緻密的 活體內可生物降解/吸收之構材合體所作成者。此植入材料 主要有下述4種： 第一種植入材料，係爲其他活體內可生物降解/吸收之構 材之軸釘’該軸釘將上述多孔體貫穿而結合爲一體，軸釘 兩端部係自上述多孔體向外突出以作爲骨固定用之植入材 料。此植入材料於例如胸骨正中切開閉鎖的手術中，適合 使用在固定切開閉鎖之胸骨的情況。 第一種植入材料，爲其他活體內可生物降解/吸收之構 材’係由具有通至外部的空洞且含有具生物活性之生物陶 瓷粉狀顆粒之活體內可生物降解/吸收之聚合物所構成的 基貞（m a t r 1X )，於該基質的空洞內裝塡有上述多孔體而結合 爲一體’上述多孔體自該基質部份露出之植入材料。此植 入材料於前方或後方椎體間固定術等中，適於使用作爲椎 16 326\ 總檔 \91 \91134292\91134292(替換)-2 1252112 體間間隔物等之椎體固定材。 第三種植入材料，爲其他活體內可生物降解/吸收之構 材’係由含有具生物活性之生物陶瓷粉狀顆粒的活體內可 生物降解/吸收之聚合物所構成的表皮層，該表皮層疊合於 塊狀的上述多孔體之表面的一部份而結合爲一體之植入材 料。此植入材料係塊狀的多孔體可發揮海綿骨的功用，表 皮層可發揮皮質骨的功用，適合使用於同種移植骨片或自 身移植骨片的代替物等之全吸收取代性之人造骨的情況。 第四種植入材料，爲其他活體內可生物降解/吸收之構 材’係由含有具生物活性之生物陶瓷粉狀顆粒的活體內可 生物降解/吸收之聚合物所構成的網狀體，於該網狀體的網 眼中充塡有上述多孔體而結合爲一體之植入材料。此植入 材料係適合使用作爲於骨缺損部位或變形部位的補綴·被 覆·支撐或塡充材等情況。 再者’應用上述多孔體的本發明之另一種植入材料，係 將上述多孔體積層於將有機纖維作成爲3軸以上的多軸三 維織造組織或編造組織或此等的複合組織之組織構造體所 構成的芯材之至少一面上，而結合成爲一體所成的人造軟 骨用植入材料。此植入材料係適合使用作爲與上下椎體結 σ而自_1L、固疋之人造椎間板或半月板等。 [實施方式] 以下，就本發明之植入材料與製造方法的較佳實施形態 加以詳述。 本發明之最基本的植入材料，係在活體內可生物降解/ 326\總檔\91\91134292\91134292(替換)-2 产 1252112 吸收之聚合物中，實質上均一分散著具生物活性之生物陶 瓷粉狀顆粒之具生物活性之活體內可生物降解/吸收的多 孔體，其係構成爲具有連續氣孔，且於氣孔內面或氣孔內 面與多孔體表面露出有部分的生物陶瓷粉狀顆粒的有機· 無機複合多孔體，於該較佳實施形態中，作爲活體內可生 物降解/吸收之聚合物，可選擇使用已實用化且安全性經確 認、分解比較快速、即使成爲多孔體也不脆的聚合物。亦 即’可使用非晶質或結晶與非晶的混合存在之完全可生物 吸收的聚-D，L-乳酸、L-乳酸與D,L-乳酸的嵌段共聚物、乳 酸與趨基乙酸的共聚物、乳酸與對二烷酮（p - d i ο X a η ο n e) 的共聚物、乳酸與乙二醇的共聚物、乳酸與己內酯的共聚 物、或此等的混合物等之活體內可生物降解/吸收之聚合 物。由本發明之製造方法中容易形成不織布狀的纖維集合 體、或活體內的多孔體的分解吸收的期間加以考量的話， 其黏度平均分子量以使用5萬〜100萬者爲佳。 尤其，依據本發明之製造方法形成不織布狀的纖維集合 體時，及將其在加熱下加壓成形所成之纖維集合體以揮發 性溶劑處理時的溶劑特性來看，以起因於單體比例而顯示 非晶性之聚-D，L -乳酸、L -乳酸與D，L -乳酸的嵌段共聚物、 乳酸與羥基乙酸的共聚物、乳酸與對二喝烷酮的共聚物等 之活體內可生物降解/吸收之聚合物爲佳，若使用此等聚合 物’可得到即使含有多量的生物陶瓷粉狀顆粒也不會脆， 具有比美海綿骨的壓縮強度，且與陶瓷單體之多孔體相 異，可在相對低溫（7 0 °C左右）下使其熱變形，在活體內可 326\總檔\91 \91 】34292\91134292(替換)-2 18 1252112 迅速地進行水解，於6〜1 2個月內全部被吸收之由有機-無 機複合多孔體所構成的植入材料。具有此等特性之植入材 料’係作爲活體骨的缺損部份所塡充之材料之極佳者，由 於爲複合物，因此與僅有陶瓷之材料相異，殘留有因樹脂 成分之黏彈性，沒有如陶瓷般地經接觸即因脆而缺損，於 手術中可使其熱變形以與缺損部份吻合的方式來成形，具 有熱塑性聚合物所特有的優點。 活體內可生物降解/吸收之聚合物的分子量，係由於會影 響到自水解到全吸收爲止的時間及能否纖維化，故宜使用 上述之具有5萬〜100萬的黏度平均分子量的聚合物。具有 較5萬小的黏度平均分子量的聚合物，其水解成寡聚物乃 至於單體單位的低分子的時間雖短，但由於牽絲性（thready) 不足’故依本發明之製造方法，以噴霧等手段在一邊纖維 化之下形成纖維集合體係屬困難。又，具有較1 〇〇萬高的 黏度平均分子量之聚合物，由於到完全水解須要長時間， 於以儘早取代活體組織爲目的之情況，作爲複合多孔體的 聚合物並不適當。雖因聚合物而異，但較佳的黏度平均分 子量宜爲大約10萬〜30萬，若使用具有此範圍的分子量之 活體內可生物降解/吸收之聚合物，則纖維集合體的形成容 易，且可得到具有適當水解結束時間之複合多孔體的植入 材料。 又，由該有機-無機複合多孔體所構成的植入材料中，作 爲分散於多孔體之生物陶瓷粉狀顆粒，可使用具有生物活 性、良好的骨傳導能（有時以骨誘導能表示）與良好的活體 19 326\總檔\91\91134292\91134292(替換)-2 1252112 親和性者。作爲此類生物陶瓷粉狀顆粒，可例舉有：表面 具生物活性之燒結、試燒結的羥磷灰石、磷灰石矽灰石玻 璃陶瓷、具生物活性且活體內完全可生物吸收的未試燒、 未燒結的經磷灰石（h y d r ο X y a p a t i t e)、磷酸二釣、磷酸三|丐、 磷酸四鈣、磷酸八鈣、方解石、塞拉凡塔（c era vital)、透輝 石（di op side)、天然珊瑚等之粉狀顆粒。又，在此等粉狀顆 粒的表面上附著有鹼性的無機化合物或鹼性的有機物等者 亦可使用。基於由本身骨組織之全取代而進行組織再生之 較理想的理由，此等之中，以可在活體內全吸收並與骨組 織完全取代之活體內完全可生物吸收的生物陶瓷粉狀顆粒 爲佳’尤因活性大、骨傳導能優異、活體親和性優異而危 害性低、且短期間內可被活體吸收，而以未試燒、未燒結 的羥磷灰石、磷酸三鈣、磷酸八鈣爲最適者。 上述生物陶瓷粉狀顆粒，以使用平均粒徑（一次粒子的平 均粒徑）爲0.2〜10 // m者爲佳，若使用較此大粒徑的生物陶 瓷粉狀顆粒，則於本發明之製造方法中，將該粉狀顆粒所 混合成的混合液噴霧以進行纖維化時，纖維會因較短而被 切斷，而難以形成纖維集合體，即使可形成纖維集合體， 在纖維固化之前，生物陶瓷粉狀顆粒多少會發生沈降導致 有分散不均一的顧慮。超過2 0〜3 0 // m之大小者，即使爲 完全可生物吸收，但因完全吸收須長時間，其間有時會發 生組織反應，故不佳。 生物陶瓷粉狀顆粒的更佳粒徑爲0.2〜5 // m，若使用此類 生物陶瓷粉狀顆粒，則即使於本發明之製造方法中，將該 20 326\總檔\91\91134292\91134292(替換)-2 1252112 粉狀顆粒以高濃度混合成之混合液，使作成纖維徑1〜3 // m 左右的方式進行細纖維化來形成纖維集合體的情況，纖維 也難以切斷，於本發明般的高濃度時，該粉狀顆粒會以自 纖維露出的狀態下被纖維包住，將纖維集合體在揮發性溶 劑中施以浸漬處理後，成爲該粉狀顆粒自表面或連續氣孔 的內面露出的複合多孔體。 生物陶瓷粉狀顆粒的含有率，在以再生醫學工程學之植 基構造或D D S用的載體或骨塡料、異形狀海綿骨（同種移 植骨片）的代替物等之醫療用途爲目的之由有機-無機複合 多孔體所構成的植入材料之情況下，係考慮生物陶瓷之生 物活性效果，而以定爲6 0〜9 0重量％爲佳。如本發明之製 造方法般形成含有生物陶瓷粉狀顆粒的纖維集合體，將其 在加熱下加壓成形所作成的纖維集合成形體，浸漬在揮發 性溶劑中以製得複合多孔體的情況，由於在可纖維化的範 圍內，可使其含有多量的生物陶瓷粉狀顆粒，故如上所述， 生物陶瓷粉狀顆粒的含有率可高達60〜90重量％ (相當於用 平均粒徑爲3 // m、比重爲2 · 7之粉狀顆粒時的容積％爲約 4 1〜8 1 %的高比例）。生物陶瓷粉狀顆粒的含有率若超過90 重量％，則於纖維化之時會被切成較短，而無法得到滿足 的纖維，故纖維集合體的形成會有困難，另一方面，若低 於60重量％，則生物陶瓷粉狀顆粒會不足，露出於表面者 較少，故自將植入材料埋入活體之初期起，即無法發揮來 自生物陶瓷粉狀顆粒物之生物活性。 如此般可將具生物活性之生物陶瓷粉狀顆粒以60〜90重 21 326\ 總檔\91 \91134292\91134292(替換)-2 1252112 量％的高含有率均一地分散的複合多孔體，係前所未有， 爲本發明之基本的植入材料之一。 生物陶瓷粉狀顆粒的較佳容積％，爲5 0〜8 5容積％。此容 積％係相對於以複合多孔體中的聚合物的氣孔率爲〇 %時的 聚合物的容積之生物陶瓷粉狀顆粒的容積百分率，所含有 的生物陶瓷粉狀顆粒的重量即使相同，基於生物陶瓷粉狀 顆粒的比重或平均粒徑，該容積％會隨之變化。因此，若 考量生物陶瓷粉狀顆粒的比重或平均粒徑，則以使其成爲 含有50〜85容積％爲佳。更佳的容積％爲50〜80容積％。 使羥磷灰石等之陶瓷燒結所得到之多孔性陶瓷，係因雖 硬卻脆，薄物受到外力時易於裂開或缺損，故作爲植入材 料係無法滿足者。相對於此，使生物陶瓷粉狀顆粒含有在 非晶性之活體內可生物降解/吸收之聚合物中之複合多孔 體，係於生物陶瓷粉狀顆粒的含有率高達60〜90重量％的 情況，因該聚合物的結合效果，而具有保持可撓性之不脆 的可比美海綿骨的壓縮強度，具體而言，爲IMP a〜5 MPa程 度的壓縮強度，如上所述，可適用於海綿骨的代替物及其 他醫藥用途。又，上述的壓縮強度係使用島津製作所（股） 製造之自動繪圖機（Autograph)AGS-2000D，依據；FISK7181 的試驗方法（惟，將樣品的大小作成爲1 0 X 1 0 X 1 5 m m，使壓 縮速度固定爲5mm/分）所測定之値。 此由有機-無機複合多孔體所構成之植入材料，氣孔率 (全氣孔率）爲5 0 %以上，於技術上雖可做到約9 0 %，但就 此複合多孔體的物理強度與骨芽細胞的侵入及安定化兩者 22 326\總檔\91\91134292\91134292(替換)-2 1252112 考量之，宜爲約60〜80%，又，考量骨芽細胞侵入到複合多 孔體的中心部的效率，連續氣孔以佔氣孔整體的5 〇〜9 0 % 爲佳，7 0〜9 0 %更佳。 此有機_無機複合多孔體的連續氣孔，其孔徑係作成爲約 100〜400 // m。經數度進行多孔質陶瓷的孔徑與骨芽細胞的 侵入及安疋化的硏究’結果得知以3 〇 〇〜4 0 0 // m的孔徑於 石灰化方面最有效果，愈與其偏離效果愈小。故此複合多 孔體的孔徑雖如上述般作成爲約1 〇 〇〜4 〇 〇 # m，但包含 50〜500// m的範圍的孔徑，分布中心以2〇〇〜4〇〇//m亦可。 在連續氣孔的孔徑較4 〇 〇 a❿大、氣孔率（全氣孔率）較 9 0 %高的情況’因複合多孔體的強度降低，故於活體內埋 入中遭破壞的顧慮甚大。另一方面，孔徑若較1 〇 〇 # m小， 氣孔率較50%低的情況’複合多孔體的強度固可提高，但 骨芽細胞難以侵入，自水解到完全吸收的時間會變長。但 此類孔徑小的複合多孔體，於作爲DDS的載體之期望可維 持與聚合物的分解並行之比較長時間的緩放性的材料，依 情況而有利用的可能。連續氣孔之較佳孔徑爲 150〜350// m，更佳之氣孔率（全氣孔率）爲7〇〜80%。又，連 續氣孔的孔徑或連續氣孔佔氣孔整體之比例，係於本發明 之製造方法中’藉由調節將纖維集合體加壓成形作成纖維 集合成形體時的壓縮率、或使纖維集合成形體保持其形狀 浸漬於揮發性溶劑中時之用以保持形狀的外壓來加以控 制。 上述般的由有機-無機複合多孔體所構成的植入材料，可 23 326V總檔\91\91134292\91134292(替換)·2 1252112 使用於例如埋入活體骨的缺損部位，此時利用活體θ 4 物降解/吸收之聚合物的熱塑性，藉由將植入材料加熱至 7〇°C以使與缺損部位的形狀吻合的方式進行變形，@ g _ 縫隙地埋入缺損部分中，故埋入作業可簡單而IE :¾丨也_ 行。又，因活體內可生物降解/吸收之聚合物所具有的$刃f生 與陶瓷的硬度，故手術中可不破壞形狀下以手術刀胃@ $ 任意形狀來使用。 當將由此複合多孔體所構成之植入材料，以上述方式埋 入活體骨的缺損部位，則液體會自複合多孔體的表面通過 連續氣孔內迅速地浸透到複合多孔體內部，故自複合多孔 體的表面與連續氣孔的內部之雙方，活體內可生物降解/ 吸收之聚合物的水解幾乎同時進行，於多孔體整體均一地 進行分解。然後，經由露出於複合多孔體的表面的生物陶 瓷粉狀顆粒的骨傳導能，於複合多孔體的表層部，骨組織 可迅速地傳導形成，而生長爲骨的小柱，短期間內，複合 多孔體可和活體骨的缺損部位結合，同時經由露出於氣孔 內面的生物陶瓷粉狀顆粒的骨傳導能，骨組織亦會侵入複 合多孔體的內部，骨芽細胞會傳導而生長，故會與周圍的 骨直接結合。此現象係隨著活體內可生物降解/吸收之聚合 物的分解之進行而變得顯著，慢慢地與周圍的骨代換。最 後，聚合物會完全被分解吸收，又，完全可生物吸收的生 物陶瓷粉狀顆粒亦完全被吸收，藉由生長的骨組織而完全 地代換，完成骨缺損部位的再生。 由此複合多孔體所構成的植入材料之活體內的濕潤特 24 3 26\總檔\91\91134292\91134292(替換)·2 1252112 性，係因多量含有而露出於表面的生物陶瓷粉狀顆粒的濕 潤特性，而較只有活體內可生物降解/吸收之聚合物的多孔 體有顯著的提高，若對此複合多孔體施行電暈放電、電漿 處理、過氧化氫處理等氧化處理，則聚合物的濕潤特性亦 可改善，應增殖的骨芽細胞之侵入、生長可更有效地進行。 又，當將各種骨形成因子、成長因子、藥劑等預先塡充 到複合多孔體的氣孔內，或預先溶解到活體內可生物降解/ 吸收之聚合物中使其載持時，則相應於複合多孔體被分解 吸收的速度，此等會慢慢放出，故可有效地促進骨的再生 及疾病的治癒。作爲主要的骨形成因子，可舉出：BMP， 作爲主要的生長因子，可舉出：IL-1、TNF-α、TNF-/S、 IFN-r 等之莫諾卡因（monocaine)或淋巴介質 (lymphokine)、或菌落（colony)刺激因子，或 TGF-α 、 TGF-0、IGF-1、PDGF、FGF等等之所謂生長分化因子。 又’作爲藥劑，可任意選擇可使骨生長之藥物（維他命D、 前列腺素類、或抗（制）癌劑等）、抗菌劑等。 其次，就本發明之由有機-無機複合多孔體所構成之植入 材料之製造方法具體地加以詳述。 本發明之製造方法’首先，將活體內可生物降解/吸收之 水口物i谷解於揮發性溶劑中，並使具生物活性之生物陶瓷 粉狀顆粒分散，以調製混合液。作爲揮發性溶劑，可使用 於較常溫稍局的溫度下容易揮發的低沸點之二氯甲烷 (cHchloromethane)、二氯乙烷、二氯甲烷（methylene chloride)、三氯甲烷等溶劑。又，亦可使用將較此等溶劑 25 3 26\總檔\91 \91134292\91134292(替換)-2 1252112 之沸點高之非溶劑之例如沸點爲60〜1 1 0 °C的範圍 醇、乙醇、1-丙醇、2-丙醇、2-丁醇、第三丁醇、第 醇等之醇類中之一種或混合二種以上所成的揮發性混 劑。 接著’由上述混合液作成不織布狀的纖維集合體。 段係以採用將溶解混合液噴霧而進行纖維化之手段爲 亦即’將上述溶解混合液裝塡於噴霧器中，以氮氣等 性高壓噴射氣體自噴霧器的噴射孔將混合液噴射到被 體’則於揮發性溶劑揮發之下逐漸纖維化，含有生物 粉狀顆粒之活體內可生物降解/吸收之聚合物的纖維 相連’在相互的接點一邊融合之下，集合固化而堆積 形成任意形狀具厚度的不織布狀的纖維集合體。此纖 合體係纖維間空隙的形狀與細胞狀的孔相異，於融合 的纖維相互間形成數百μ m程度的連續空間，生物陶 狀顆粒被纖維所包住（亦有部分露出於表面者），在纖 合體的整體中均一地分散著。 將此般含有6 0重量％以上（有時爲5 0容積％以上）的 的生物陶瓷粉狀顆粒之樹脂，在不會沈澱分離之下， 一分散之狀態下固化而固定，且作成在內部包含有作 孔之連續空間的材料，故採用如本製造方法般之經由 方式’於一邊形成細纖維之下使溶劑揮發，於生物陶 狀顆粒分離之前，進行短時間內固化的手段，係極具 者’亦爲本發明之製造方法之新穎性之所在。 又’欲製得作爲醫療用途之植入材料時所必要的5〜 326\總檔\91 \91134292\91134292(替換 之甲 三戊 合溶 其手 佳。 非活 噴射 陶瓷 交互 ，可 維集 固化 瓷粉 維集 多量 以均 爲來/ 噴霧 瓷粉 道理 5 0mm 26 1252112 的極厚的複合多孔體，可經由噴霧形成此纖維集合體之 後，使溶劑揮發待其乾燥，再於其上反覆進行噴霧以增厚 的操作，作成既定的厚度。 作爲上述被噴塗物，可使用由剝離性良好的聚乙烯、其 他儲羥系樹脂、氟樹脂、砂系樹脂等所構成之網狀體或板 狀體。尤其，若使用網狀體般的可自由通氣的被噴塗物， 則具有經由噴霧會使混合液纖維化，於碰到網狀體後，揮 發性溶劑會通過網眼而揮發，故網狀體側表面的纖維會融 合，而不生成表皮層（只有樹脂的融合層），有可輕易形成 以其後的步驟進行溶劑之浸透處理的纖維集合體之優點。 作爲網狀體，以50〜300網眼者爲佳，具有大於50網眼之 網狀體，由於纖維會通過網眼包入到背側，故欲將形成的 纖維集合體自網狀體剝離會變得困難，而具有較300網眼 更小之網狀體，由於揮發性溶劑難以順利揮發，網狀體側 的纖維會融合而易形成表皮層。又，被噴塗物並不限於平 坦的網狀體或板狀體，亦可使用凸曲及/或凹曲之立體的網 狀體或板狀體。若使用此類立體的被噴塗物，有可依其立 體的形狀形成厚的纖維集合體之優點。 如上述般將混合液噴霧進行纖維化所形成的纖維集合 體，其纖維間的空隙大至數百μ m，纖維空隙所佔的比例 (空隙率）爲60〜90%左右。而纖維中含有之無機粉狀顆粒， 不會沈降而在纖維集合體的整體上均一地分散著。 此纖維集合體的纖維長度以3〜100mm左右爲佳，纖維徑 以0.5〜50 // m左右爲佳。具有此種程度的纖維長度及纖維 27 326\總檔\91 \91134292\91134292(替換)-2 1252112 徑之纖維集合體’經由隨後之步驟的溶劑浸透處理，纖維 可谷易地融合’可用以作成實質上纖維已消失之複合多孔 體，故較佳。 纖維長度’主要係依賴於活體內可生物降解/吸收之聚合 物的分子量、混合液的聚合物濃度、生物陶瓷粉狀顆粒的 含有率或粒徑等，分子量愈大、聚合物的濃度愈高，生物 陶瓷粉狀顆粒的含有率愈少、生物陶瓷粉狀顆粒的粒徑愈 小，則纖維有愈長的傾向。另一方面，纖維徑，主要係依 賴於混合液的聚合物濃度、生物陶瓷粉狀顆粒的含有率、 噴霧器的噴射孔大小等，聚合物的濃度愈高、生物陶瓷粉 狀顆粒的含有率愈多、噴射孔愈大，則纖維徑有愈粗的傾 向。又’纖維徑亦因噴射氣體的壓力而變化。因而，爲了 作成上述的纖維長度及纖維徑，須就聚合物的分子量、聚 合物濃度、生物陶瓷粉狀顆粒的含有率與粒徑、噴射孔的 大小、氣體壓力等加以調整。 接著’進入到將上述纖維集合體在加熱下加壓成形作成 多孔質的纖維集合成形體的步驟。首先，將纖維集合體在 加熱/加壓下固化，製作成具有連續的空隙之預成形物，進 而在較此時的壓力高之壓力下，對預成形物進行加壓成 形，作成連續空隙率與孔的大小經調整之具強度的多孔質 的纖維集合成形體。又，加壓成形時的加熱係使纖維集合 體稍微軟化的程度，又，加壓的程度係以使最終得到之複 合多孔體的氣孔率成爲50〜90%，且連續氣孔的孔徑成爲約 10 0〜400 β m的方式作調節即可。 28 326\總檔\91 \91134292\91134292(替換)-2 1252112 然後，進入次一步驟中，將前步驟中得到之纖維集合成 形體浸漬到上述揮發性溶劑中，使該溶劑充分地浸透到成 形體內部。然後’將此溶劑除去。於將纖維集合成形體浸 漬到揮發性溶劑中之時，將纖維集合成形體充塡到有著具 有多數細孔的面之模具中，於自外側對纖維集合成形體施 加適度的壓力之狀態下，於保持其形狀下進行浸漬。或者， 亦可對纖維集合成形體的上面以溶劑流過使其浸透的方式 進行。又，爲保持既定的形狀，以將纖維集合成形體內部 的溶劑以真空吸引的方法儘早除去爲佳。 如上述般將纖維集合成形體浸漬到揮發性溶劑中，使溶 劑浸透到成形體內部，則纖維由表面起溶解到溶劑中，於 一邊收縮下纖維彼此間進行融合，實質上使纖維消失形成 氣泡膜。然後，在形成具有空隙爲100〜400 // m左右的孔 徑的具有圓形的連續氣孔殘留之狀態下，形成氣泡壁，使 連續氣孔進行形態變化。然後，多量地含於纖維中之生物 陶瓷粉狀顆粒的一部份，隨著此纖維的融合、成膜之形態 變化，在不沈降下被包埋於氣孔膜內（氣泡壁內），同時其 一部份自氣孔膜露出，於多孔體表面該粉狀顆粒也在不易 脫落的程度下塡入並露出。但依條件而亦有表皮層於表面 上形成而生物陶瓷粉狀顆粒不露出多孔體表面的情況，此 時，亦可施行以磨砂將表皮層去除，使存在於表層的無機 粉狀顆粒露出的做法。 如此，可製得由具有連續氣孔，且在多量的生物陶瓷粉 狀顆粒均一分散之同時，於氣孔內面與多孔體表面露出有 29 3 26\總檔\91\91134292\91134292(替換)-2 1252112 一部份的生物陶瓷粉狀顆粒之由有機-無機複合多孔體所 構成的植入材料。此複合多孔體係於將纖維集合成形體浸 漬到揮發性溶劑中之時，經由施加用以保持其形狀的外壓 之調節，可將連續氣孔的孔徑控制在適合於骨芽細胞之侵 入與安定化所須之較佳的1〇〇〜400 //m左右，並且將氣孔 率控制於50〜90%的程度。又，於50〜60°C的加熱下，進行 對纖維集合成形體的揮發性溶劑之浸漬處理，僅須將纖維 集合成形體短時間放置，纖維彼此即可充分地融合，可有 效率地得到複合多孔體。 本發明之製造方法中，於可纖維化之範圍內，可將60〜90 重量％(相當於在平均粒徑3 // m、比重2.7的未燒結羥磷灰 石時之41〜81 %容積％)的生物陶瓷粉狀顆粒均一地使其含 有在複合多孔體中，即使是多量含有，由於在生物陶瓷粉 狀顆粒沈降分離之前，溶劑即會揮發使纖維融合，故較上 述溶液沉澱法所得之多孔體，可製得生物陶瓷粉狀顆粒更 均一地分散，而迄今所無法製得之高含有率之複合多孔 體。但若含有率過高，則作爲結合劑之活體內可生物降解/ 吸收之聚合物的量會變少，複合多孔體會變脆，欲維持形 狀會變得困難，故有其上限。 (實施例） 接著，就本發明之由有機-無機複合多孔體所構成之植入 材料，更進一步以具體的實施例加以說明。 (實施例1) 將黏度平均分子量爲20萬的聚-D，L-乳酸（PDLLA)(D-乳 30 326\總檔\91 \91134292\91134292(替換)-2 1252112 酸與L-乳酸的莫耳比爲5 0/5 0)溶解於二氯甲烷中所成之聚 合物溶液（濃度：PDLLA 4g/二氯甲烷100ml)，與平均粒徑 3 // m之未燒結的羥磷灰石粉狀顆粒（U_HA粉狀顆粒）混合 到乙醇中之混合液，進行均一地均質化，藉此調製成以 u-HA粉狀顆粒相對於PDLLA 100重量份爲2 3 0重量份的比 例之方式所混合成之混合液。 噴霧器係使用HP-E氣刷（阿涅斯特岩田（股）製），將上述 懸浮液裝入其中，以壓力1.6kg/cm2的氮氣，噴霧到距離約 12 0cm遠之聚乙烯製網狀體（150網眼）上，形成纖維集合 體，自網狀體將纖維集合體剝離。此纖維集合體的纖維徑 爲 1.0//m左右，纖維長度爲 10〜20mm左右，視比重 (apparent specific gravity)爲 0.2 〇 將此纖維集合體切斷成適當的大小，充塡到直徑30mm、 深度30mm的圓筒母模中，經由以使纖維集合體的視比重 成爲0.5的方式用公模進行壓縮，得到直徑30mm、厚度 5mm的圓板狀的纖維集合成形體。 然後，將上述纖維集合體浸漬到由混合有乙醇的二氯甲 烷所成的溶劑中，使該溶劑浸透到成形體內部，於6CTC下 放置1 0分鐘後，將成形體內部的溶劑經由真空吸引除去， 得到直徑30mm、厚度5mm、u-HA粉狀顆粒的含有率爲70 重量％之有機-無機複合多孔體。 對此複合多孔體的部分剖面以電子顯微鏡觀察，得知纖 維經融合而消失，形成具有100〜400 // m左右的大孔徑之 連續氣孔，u-HA粉狀顆粒均一地分散，於氣孔內面與多孔 31 3 26\總檔\91 \91134292\91134292(替換)-2 1252112 體表面有u-HA粉狀顆粒的一部份露出著。此複合多孔體 的視比重爲0.5，連續氣孔佔氣孔整體的比例（連續氣孔率） 爲75%，壓縮強度爲l.lMPa。 (實施例2) 以與實施例1同樣地，作成直徑30mm、厚度5mm的圓 板狀的纖維集合成形體以作爲預成形體，使其在齒輪式烘 箱中加熱至8 0 °C後，置入具有直徑逐漸縮小的縮徑部的室 中’將其壓入下部直徑爲10.6mm的圓筒中。依此作出之 在加熱下所加壓成形之圓柱棒狀的纖維集合成形體的壓縮 強度約爲2.5 Μ P a。 然後’將此圓柱棒狀的纖維集合成形體充塡到周圍有開 孔的同徑之圓筒中，自其上、下面施加壓力，於不改變圓 柱棒狀的纖維集合成形體高度之程度下給予壓迫之同時， 將其浸漬到由混合有1 5重量％的甲醇之二氯甲院所形成的 溶劑（6 0 °C )中1 0分鐘後，將該溶劑除去，得到複合多孔體。 對此複合多孔體的部分剖面與經磨砂的表面以電子顯 微鏡照相觀察，得到纖維消失之多孔質的形態，孔徑爲 1 5 0〜3 0 0 // m左右的混合孔所形成，u - Η A粉狀顆粒自多孔 體表面或氣孔內面露出。此複合多孔體的視比重約〇. 5 5， 連續氣孔率爲70%，壓縮強度上昇到約3.5MPa。本複合多 孔體，若由PDDLA的黏度平均分子量與所佔的比例、平均 粒徑3 μ m的u-HA粉狀顆粒之活體內的活體內分解吸收特 性來推算，雖依賴於埋入部位或尺寸而異，推沏j可以6個 月至1 2個月來完全吸收。 32 326\總檔\91\91134292\91134292(替換)-2 1252112 (實施例3 ) 合成黏度平均分子量爲1 〇萬的P D L L A (D -乳酸與L -乳酸 的莫耳比爲3 0/70)，與實施例1同樣的方法調製將平均粒 徑3 // m左右的/3 -磷酸三鈣粉狀顆粒（々_ τ c P粉狀顆粒）8 0 重量％均一混合所成之混合液。此/9 - T C P粉狀顆粒經確認 係具生物活性及活體內吸收性，其機制雖與u _ Η A粉狀顆 粒相異，但可知其顯示有在活體內HA生成之骨傳導性。 用此混合液，將與實施例2同樣的噴霧法製作的纖維集 合體於加熱下，壓縮成形爲纖維集合成形體，經由對其進 行溶劑浸漬處理，得到視比重約0 · 6、連續氣孔率爲7 5 %、 壓縮強度爲4.2MPa的複合多孔體。此複合多孔體的/5 -TCP 粉狀顆粒的體積比例約爲6 5容量％，万-T C P粉狀顆粒的體 積比例遠較u-HA粉狀顆粒爲70重量％(約55容量％)的實 施例1、2的複合多孔體大，故藉由多孔體的表面或氣孔內 面之/3 -TCP粉狀顆粒的露出，生物活性可顯著地發揮。 此複合多孔體，於不織布狀的纖維集合體時的纖維消 失，而變化成 /3 -TCP粉狀顆粒埋入塊狀（bulk)胞壁的形 態，故即使在浸漬於活體內的體液中時，也不易崩解致粉 狀顆粒分散到周圍，確認其以5〜8個月程度即顯示良好的 生物活性並可完全被分解吸收。因此，此複合多孔體可成 爲良好的硬組織（硬骨、軟骨）用的植基構造。 (實施例4) 將D，L-乳酸（D/L的莫耳比1)與羥基乙酸（GA)，以莫耳比 成爲8 : 2之方式來配合，以既知的方法合成黏度平均分子 33 326\總檔\91\91134292\91134292(替換)-2 1252112 量爲13萬的共聚物P(DLLA-GA)。與實施例}同樣地，調 製將磷酸八鈣粉狀顆粒（OCP粉狀顆粒）60重量％均一混合 於此聚合物之混合液’將以與貫施例2同樣的噴霧法製作 之纖維集合體，在加熱下壓縮成形爲纖維集合成形體，經 由對其進行溶劑浸漬處理，最後得到視比重爲〇·5〇的複合 多孔體。此複合多孔體係OCP粉狀顆粒的活性度高，共聚 物的分解吸收因G A而快速，故顯示出良好的骨傳導（容易 轉變成新生骨），同時於3〜4個月後，其大半都被吸收而代 換爲骨。 (實施例5) 將D，L-交酯與對二呤烷酮（p-D〇X)以該莫耳比爲8:2之 方式配合，以既知的方法進行共聚合，得到黏度平均分子 量約爲1 0萬的共聚物。p - D Ο X的聚合物雖找不到揮發性的 泛用優良溶劑，但以上述比例則可溶於氯仿、二氯甲烷等， 故以與上述實施例1同樣的方法可得到標的物之複合多孔 體。又，上述共聚物係較實施例4的D，L-乳酸與羥基乙酸 之共聚物 P(DLLA-GA)更顯示具有可塑性之橡膠般的性 質，故於生物陶瓷粉狀顆粒的粒徑爲3 // m時，該粉狀顆 粒的體積比例可高達7 0容量％ ( 8 5重量％ )，故此複合多孔 體係可極力避免因共聚物的分解生成物之活體反應，而可 極有效地發揮具生物活性之生物陶瓷粉狀顆粒的活性度。 尤其，自P-DOX的特性，其親水性較PDLLA高，故此複 合多孔體於活體外可使細胞增殖，因此於作爲軟骨的再生 之植基構造甚爲有效。 34 326\總檔\91\91134292\91134292(替換)-2 1252112 如上所述’由本發明之有機-無機複合多孔體所構成的植 入材料，含有均一分散於活體內可生物降解/吸收之聚合物 的多量的生物陶瓷粉狀顆粒，通過形成於內部之孔徑大的 連續氣孔，體液等可迅速浸入，經由露出於多孔體表面或 連續氣孔內面之生物陶瓷粉狀顆粒的骨傳導能，可進行早 期地與活體骨結合或活體骨組織的再生，具有醫療用途所 必須的實用強度，可以本發明之製造方法容易且確實地製 造。因此，此植入材料係如上述，可應用於作爲活體骨組 織重建用植基構造、補綴材、骨塡料、其他植入材料與活 體骨組織間的介在物、海綿骨的代替物、藥物緩放用載體 等。 其次’參照圖式，就應用上述有機-無機複合多孔體之本 發明之植入材料的代表性實施形態詳加敘述。此植入材料 可槪分爲由上述多孔體與其他緻密質的活體內可生物降解 /吸收之構材一體化所成的形態，與由上述多孔體與活體內 非吸收性構材一體化所成的形態；前者之植入材料之主要 者係可舉出圖1〜圖1 5所示之各種實施形態，而後者則可 舉出圖1 6、圖1 7所示之實施形態。 圖1所示之植入材料1 〇係正中切開閉鎖之胸骨固定用植 入材料’爲因骨質疏鬆症之骨量減少或骨骼組織萎縮導致 骨樑變粗、變細的部位的骨之切開、鋸骨、或骨折之部位， 將其經由手術進行閉鎖、接合時所埋入之具生物活性且可 生物降解/吸收的骨固定用的植入材料的代表例。 此植入材料1 〇係具備有有機-無機複合多孔體1與作爲 35 326\總檔\91 \91134292\91134292(替換)-2 1252112 活體內可生物降解/吸收之構材之軸釘2，軸釘2貫穿多孔 體1，軸釘兩端部自該多孔體1突出。而且，爲使於埋入 胸骨中時不會旋轉，軸釘2在形成爲角柱狀之同時，多孔 體1形成爲長方體狀。又，軸釘2的兩前端係形成爲可容 易插入形成於胸骨的骨髓（海綿骨）上的孔之角錐狀，此軸 釘2的兩端部的表面，形成有用以阻止自上述孔拔出軸釘 2之截面爲鋸齒狀的凹凸2a。又，於使軸釘2形成爲圓柱 狀之同時，多孔體1亦可形成爲圓筒狀，或將軸釘兩端部 的凹凸2a省略亦可。 多孔體1係與上述有機-無機複合多孔體相同者，亦即， 係在活體內可生物降解/吸收之聚合物中，實質上均一分散 著具生物活性之生物陶瓷粉狀顆粒所成之活體內可生物降 解/吸收的多孔體，爲具有連續氣孔，且於氣孔內面與多孔 體表面有一部份的生物陶瓷粉狀顆粒露出者。此多孔體1 的氣孔率、連續氣孔的孔徑、連續氣孔佔氣孔整體的比例、 活體內可生物降解/吸收之聚合物、生物陶瓷粉狀顆粒、該 粉狀顆粒的含有率等係如上所述。 此多孔體1係依據上述製造方法，將不織布狀的纖維集 合體在加熱下，加壓成形爲長方體形狀以作成多孔質的纖 維集合成形體，將其浸漬於揮發性溶劑中以得到長方體形 狀的有機-無機複合多孔體，經由對其穿孔作成用以插通軸 釘2的角孔（較軸釘2尺寸稍小的角孔）而製成。 此多孔體1的尺寸可依病例而選定，其大小並無特別限 定，惟須留意不要使其過大（多）。於胸骨固定用的植入材 3 26\總檔\91\91134292\91134292(替換)-2 36 1252112 料的情況，以將多孔體1的長度設定爲丨〇〜丨5mm左右、寬 度設定爲6〜20mm左右、高度設定爲6〜15 mm左右爲佳。 此範圍內之選擇係依賴於患者的胸骨構造，無需多說。多 孔體1的各尺寸若低於上述範圍的下限，則傳導形成到多 孔體1的骨組織會較少。又，此多孔體1之較佳尺寸亦須 因應所要埋入的骨而變化，無需多說。 在此多孔體1中，經由使其適量含有上述骨形成因子、 生長因子、藥劑等，可增進其功能性。若含有骨形成因子 或生長因子，則會顯著地促進多孔體1內部的骨形成，可 較早使多孔體1代替骨組織，於切開閉鎖之雙方的半胸骨 可直接結合。而且，若使其含浸於藥劑中，則藥劑可被雙 方的半胸骨直接吸收而可充分發揮藥效。又，於此多孔體 1的表面’施以上述氧化處理以改善濕潤特性，可更有效 地使骨芽細胞侵入、生長，故佳。 另一方面’上述軸釘2係使用由經確認安全性的結晶性 的聚乳酸及聚羥基乙酸等之活體內可生物降解/吸收之聚 合物所構成者，尤其以黏度平均分子量爲15萬以上（20萬 〜60萬左右更佳）的活體內可生物降解/吸收之聚合物所構 成的筒強度軸釘2更佳。又，由對此等活體內可生物降解/ 吸收之聚合物，以上述具生物活性之生物陶瓷粉狀顆粒 10〜60重量％左右所混合成的複合物所構成的軸釘，或經由 壓縮成形、鍛造成形、延伸等方法，使上述聚合物分子或 結晶進行配向以更提高其強度的軸釘，亦適合使用。尤其 是經由鍛造成形使聚合物分子或結晶成三維配向之緻密質 37 326\總檔\91 \91134292\91134292(替換)-2 1252112 者係較佳之可採用者。 於胸骨固定用之植入材料的情況，軸釘2的長度以 20〜4 Omm左右爲佳，若未滿20mm，則作爲胸骨固定用的軸 釘會太短，反之，若較40mm長，則會產生難以納入胸骨 的骨髓（海綿骨）中之不良情況。又，軸釘2的寬度以2〜4mm 左右爲佳，高度以2〜3 mm左右爲佳。若軸釘2的寬度較2mm 狹小、高度較2mm小的情況，會變得太細而有易於折斷軸 釘2的顧慮，另一方面，若軸釘2的寬度較4mm寬、高度 較3mm大的情況，與多孔體1的組合將超過胸骨的厚度而 不可行。又，上述之軸釘尺寸，不過爲胸骨固定用的植入 材料的情況之較佳尺寸，其可因應要埋入的骨而改變軸釘 的較佳尺寸，無需多說。 接著，參照圖2就上述胸骨固定用的植入材料1 〇之使用 例加以說明。 首先，如圖2 (a)所示般，經正中切開之左右的半胸骨b， 於B將2條鋼線 3，3使用突錐穿通之同時，以收束帶4通 過半胸骨B，B的肋骨間而捲繞。於圖2 (a)中，雖只捲繞1 條此收束帶4 ’但作成以上下隔開間隔捲繞著複數條（通常 爲4條）之方式。然後’將雙方的半胸骨b，B的不要的海綿 骨以杓子（kocheO等刮出’形成可將胸骨固定用的植入材料 1 〇的單側一半份插入的複數個孔5(較植入材料1 〇具稍小 尺寸之孔）。 接著’如圖2 (b)所示般，將植入材料1 〇的單側一半部份 以使其不會拔出的方式強力擠壓入單片的半胸骨B的各孔 326\總檔\91\91134292\91134292(替換)-2 38 1252112 5中。然後，如圖2 (c)所示般，穿引鋼線3，3，在分別將植 入材料1 0的反對側半份擠壓入另一方的半胸骨B的各孔5 中之同時’將雙方的半胸骨B閉鎖，將鋼線3,3的端部打 結數次以紮實地綁牢，再將各收束帶4打結數次以紮實地 綁牢。又，此實施形態中，雖使用鋼線3及收束帶4將半 胸骨B，B固定，但亦可使用上述聚乳酸般的活體內可生物 降解/吸收之聚合物或使此聚合物含有生物陶瓷粉狀顆粒 而成形之條帶。 若將上述般的胸骨固定用之植入材料1 〇埋入經切開、閉 鎖之胸骨的骨髓中，則於埋入初期，植入材料1 〇的軸釘2 係作爲「楔子」突刺於雙方的半胸骨B，B之骨髓（海綿骨）， 將雙方的半胸骨B，B固定以發揮補強作用，故可提高雙方 的半胸骨的固定安定性。其後，經由露出於此植入材料1 〇 的多孔體1的表面之生物陶瓷粉狀顆粒的骨傳導能，骨組 織可傳導形成於多孔體1的表面，由於在短時間內多孔體 1與雙方的半胸骨B，B的骨髓會進行結合，故經由此結合 可提高雙方的半胸骨B，B的固定安定性與強度。 此植入材料1 0，經由與骨髓中的體液之接觸，軸釘2與 多孔體1皆會進行水解，由於多孔體1會通過連續氣孔， 使體液侵入到內部，故水解快速，而且，此多孔體1，經 由露出於氣孔內面之生物陶瓷粉狀顆粒物的骨傳導能，骨 組織會傳導形成到內部，於較短期間內與骨組織代換而消 失。尤其於對多孔體1以上述生長因子含浸的情況，骨組 織的生長迅速，於短期間內骨組織可與多孔體1代換。因 39 3 26\總檔\91 \91134292\91134292(替換)-2 1252112 此’經閉鎖的胸骨（半胸骨B，B )由於藉由與多孔體1代換之 骨組織而可直接結合，故即使疏鬆症的胸骨之海綿骨爲極 端空洞化且多孔質化成爲薄板般變脆，亦可藉由所形成的 新生骨，使胸骨的固定得以安定化。 另一方面’植入材料1 〇的軸釘2，經由與體液的接觸， 會慢慢地進行水解’於多孔體丨與骨組織代換之時，水解 已進行甚多’不久即變成細片，最後全部會被體內吸收而 消失。該情況下’當軸釘2爲如上述般之由活體內可生物 降解/吸收之聚合物與生物陶瓷粉狀顆粒物的複合物所構 成者’且軸釘2亦有骨傳導性，故經由水解與生物陶瓷粉 狀顆粒之骨芽細胞與破骨細胞的代換之反覆進行，會傳導 形成骨’連同進行分解細片的吞噬反應，軸釘2會與骨組 織代換’軸釘2所突刺著的孔最後會被新生骨埋沒而消失。 由本發明之有機-無機複合多孔體1與軸釘2所構成的骨 固定用之植入材料1 〇係如上所述，於胸骨正中切開閉鎖的 手術中’不只可使用於埋入於經切開閉鎖之胸骨，亦可使 用於因骨質疏鬆症導致的骨量減少或骨骼組織萎縮，骨骼 變粗變細的部位之切開、鋸骨、或骨折的部位之經由手術 進行閉鎖、接合時之埋入，最後會代換骨組織而可將骨強 固地接合固定。 圖3所示之植入材料Π，爲如圖6所示般之作爲椎體間 間隔物等之椎體固定材’主要用以插入頸椎C3-C4或腰椎 L4-L5間所使用者。此植入材料丨丨係由有機_無機複合多孔 體1與具備有通到外部的空涧6a的活體內可生物降解/吸 40 326\總檔\91\91134292\91134292(替換)-2 1252112 收之構材之基質6所構成者，多孔體1係裝塡於基質6的 空洞6a中’而自該空洞6a的入口 6b部分露出著，又，於 基質6的上下亦有多孔體1疊合成板狀而設置。此基質6 上下之多孔體1係用於作爲自身骨的代替，如後述般，係 爲了可使基質6與頸椎C3-C4或腰椎L4-L5之間隙消失，並 早期結合（固定）而設置。又，基質6上下之多孔體丨亦可 省略。 此植入材料丨丨的基質6係由含有具生物活性之生物陶瓷 粉狀顆粒之活體內可生物降解/吸收之聚合物所構成的緻 密質的具強度的基質，如圖4所示般，係形成爲長方體形 狀。於此基質6中，係以可互相交絡的方式形成有可通至 外部之縱方向的二個貫穿孔狀的空洞6a與橫方向的二個 貫穿孔狀的空洞6 a，此等空洞6 a的入口 6 b，於基質6的 上下左右4面分別有2個開口。此等空洞6a的入口 6b， 由於爲液體等之侵入口，故裝塡於空洞6 a內之多孔體丄 自各入口 6b呈部分露出的狀態。又，空洞的入口 6b亦 可在基質6的前面或後面形成，此情況下，作成使後面的 入口形成爲螺絲孔狀，以使插入之夾具的前端可鎖入的方 式爲佳。 此植入材料11爲了使其容易插入頸椎C3_C4或腰椎L4_L5 間’於基質6的前面6 c的四周削成傾斜面。然後，爲了使 其成爲於插入頸椎C 3 - C 4或腰椎L 4 - L 5間後，不會位置偏移 或脫離之自立型（不要補助固定材）的植入材料丨丨，於基質 6的上下兩面6d、6e上設置有數個（圖中各爲6個）固定用 326\總檔\91 \91134292\91134292(替換)-2 1252112 的突起6f，各突起6f的前端部係自基質6的上下兩面的多 孔體1突出。此突起6f係如圖4所示般，於基質6的上下 兩面形成有凹穴6g’在與基質6相同之由活體內可生物降 解/吸收之聚合物所構成的前端，將圓錐狀之尖的軸釘 6h(6f)植設於凹穴6g中者。又，亦可於前端植設尖的突片， 亦或可使突起6f與基質6 —體成形，以替代軸釘。 如圖5所示般，於基質6的縱方向的二個空洞6 a，6 a之 間的壁部，形成有連通孔6j，如後述般，爲在裝塡於空 洞之多孔體1，1上傳導形成的骨組織，通過連通孔6 j而可 連結之構成。此壁部6i係用以提高基質6的耐壓強度。 基質6的尺寸，以前後尺寸爲18〜30mm左右，上下高度 及左右寬度的尺寸爲6〜24mm左右，若採用此等範圍內的 各種此寸，則可選擇適合於頸椎C3-C4或腰椎L4-L5的尺寸 及椎間的尺寸者來插入。 植入材料1 1的基質6，係使縱方向及橫方向的空洞6a 形成爲剖面爲長圓形的貫穿孔狀，但亦可形成爲四方形、 圓形、橢圓形等之具有各種剖面形狀的貫穿孔狀。又，亦 可將基質6內部全體作成爲中空室狀的空洞，使該空洞的 入口形成在基質6的上下左右4面，而可與外部連通。 又，貫穿於基質6的橫方向之空洞6a亦可省略，只要有 貫穿於縱方向的空洞6a，自上下頸椎C3-C4或腰椎LiL5 使骨組織傳導形成在裝塡於內部的多孔體1上而可癒合、 固定。又，基質6的左右2面的入口 lb亦可省略。 上述基質6係由含有具生物活性之生物陶瓷粉狀顆粒之 42 326\總檔\91\91134292\91134292(替換)-2 1252112 活體內可生物降解/吸收之聚合物所構成者，作爲原料的活 體內可生物降解/吸收之聚合物，以使用與上述植入材料 1 0的軸釘2同樣的聚合物，亦即，經確認活體內之安全性 之結晶性的聚-L-乳酸或聚羥基乙酸等爲佳，尤其是使用黏 度平均分子量爲15萬以上（20萬〜60萬左右更佳）的聚-L-乳酸之高強度的基質6較佳。此類基質6可經由用活體內 可生物降解/吸收之聚合物進行射出成形、或對活體內可生 物降解/吸收之聚合物的成形塊狀物進行切削加工等方法 來製作，於後者的方法中，將成形塊狀物以壓縮成形或鍛 造成形等手段，使聚合物分子或結晶進行配向以作成塊狀 物，將其切削加工所製得的基質6，因質地緻密且聚合物 分子或結晶成三維配向，使強度更加提高，故爲佳。此外， 亦可用作爲成形塊狀物之經延伸成形的塊狀物，並以使延 伸方向（配向方向）爲縱方向的方式進行切削加工以提高強 度，故佳。 作爲此基質6中所含有之生物陶瓷粉狀顆粒，上述的具 生物活性之完全可生物吸收的生物陶瓷粉狀顆粒均可使 用’其含有率與上述的植入材料1 〇的軸釘2同樣地，以 1 0〜6 0重量％爲佳。若未滿1 〇重量％，則因生物陶瓷粉狀 顆粒之骨傳導形成不充分’若超過6 〇重量％，則會發生基 質6脆弱化之不良情形。 另一方面，充塡於基質6的空洞6&之多孔體1，爲與上 述有機-無機複合多孔體相同者，亦即，在活體內可生物降 解/吸收之聚合物中，實質上均~分散著具生物活性之生物 326\總檔\91 \91134292\91134292(替換)-2 43 1252112 陶瓷粉狀顆粒所成之活體內可生物降解/吸收的多孔體，爲 具有連續氣孔，且於氣孔內面或氣孔內面與多孔體表面有 部份生物陶瓷粉狀顆粒露出者。此多孔體1的氣孔率、連 續氣孔的孔徑、連續氣孔佔氣孔整體的比例、活體內可生 物降解/吸收之聚合物、生物陶瓷粉狀顆粒、該粉狀顆粒的 含有率等，係如上所述。 又，基質6上下之多孔體1，形成有通過基質6的突起 6f的孔，疊合於基質6的上下兩面6d，6e上，以熱融合等 手段固定。此基質6上下的多孔體1之厚度以0.5〜3mm左 右爲佳，於較0 · 5 m m薄的情況，會難以吸收因壓縮變形之 頸椎C3-C4或腰椎L4-L5表面的凹凸，故有與頸椎C3-C4或 腰椎L4-L5的密著性降低的顧慮，反之，於較3mm厚的情 況，其分解吸收及與骨組織間的代換所要的時間會變長。 對裝塡於基質6的空洞6a之多孔體1或疊合在基質6 上下而爲一體之多孔體丨’以適量含有上述的骨形成因 子、成長因子、藥劑等爲佳，又，亦可在多孔體1的表面 施以上述氧化處理以改善濕潤特性。 上述植入材料1 1係如圖6所示般地，用插入夾具在頸椎 C3 - C4或腰椎L4 - L5間插入左右一對，藉此可橋正頸椎c 3 - C 4 或腰椎L4-L5的間隔或姿勢。若如此般地將植入材料n插 入，則基質6上下兩面的多孔體1，丨會因頸椎c 3 _ c 4或腰椎 L4-L5的夾壓力而受壓縮，使頸椎c3-c4或腰椎L4-L5無空隙 地密合’並且基質6上下兩面的突起6f會嵌入頸椎c3_c4 或腰椎L4-L5的海綿骨，使植入材料丨丨在不會位置偏移或 44 326\總檔\91 \91134292\91134292(替換)-2 1252112 脫離之下固疋住’因基質6爲長方體形狀而可安定設置。 當這樣地將植入材料1 1插入頸椎C3-C4或腰椎L4-L5間 而設置，則具有充分強度之與活體的皮質骨有同樣作用之 基質6會與體液接觸，而自表面開始慢慢地進行水解。其 次’與海綿骨有同樣作用之多孔體1，經由自其露出部分 通過連續氣孔浸透到內部之體液而快速進行水解，且經由 生物陶瓷粉狀顆粒的骨傳導能，骨芽細胞會侵入多孔體1 的內部而傳導形成骨組織，故在較短期間內多孔體1會與 骨組織代換。因而，上下的頸椎C3-C4或腰椎L〇L5，可經 由此代換的骨組織而癒合、固定。另一方面，基質6係自 初期起’其壓縮強度與習用的碳製護架同樣地高，多孔體 1在進行骨代換後亦可繼續維持強度，植入材料1 1可完全 地與頸椎C1-C4或腰椎L4-L5癒合而呈力學上固定，而發揮 大的效用，其後經過數年（約5年）與骨組織之代換即可完 成。此時可獲得完全地因活體骨之固體狀的癒合。 骨組織的傳導形成係因基質6上下兩面的多孔體1被壓 縮’而使頸椎C3_C4或腰椎L4-L5沒有空隙地密合著，多孔 體1與上述有機-無機複合多孔體爲相同者，由於含有具有 骨傳導能之生物陶瓷粉狀顆粒60〜9〇重量％，氣孔率爲 50〜90% ’連續氣孔佔氣孔整體的50〜90%，連續氣孔的孔徑 爲約100〜400 //m，故骨芽細胞容易侵入而可確實進行，骨 組織傳導形成於基質6上下兩面的多孔體丨的表層部之初 期階段中，植入材料11與上下頸椎c3_c4或腰椎l^l5直 接結合而固定。 45 1 26\總檔\91 \91134292\91134292(替換)_2 1252112 如上所述，此植入材料1 1係因基質6與多孔體1均被分 解吸收而與骨組織代換，並非作爲異物而存在於活體內， 故習用之作爲椎體固定材所使用之鈦製或碳製護架有在活 體內長期存在之危害性的發生之顧慮，或因活體與力學特 性的不一致所產生之於椎體內下沈的問題，均得以一掃而 空。而且’因多孔體1可進行與活體骨同樣的組織學作用， 而與骨組織代換，故沒有以往之爲了塡充於護架中，而須 擷取腸骨等以作爲移植用自身骨；移植用自身骨的獲得量 不足之問題或擷取後的手術時處理煩瑣的問題亦得以一掃 而空。 此植入材料1 1係基質6上下兩面6d，6e呈水平面，但亦 可使上面6 d往前下傾斜，使下面6 e往前上傾斜，以作成 爲前端變狹窄狀的基質6，若作成如此，則可成爲適於將 腰椎矯正爲前彎姿勢之植入材料。 又’基質6的形狀並非限定於上述的長方體形狀，亦可 作成爲適合於頸椎、腰椎、脊椎及其他使用部位之各種形 狀。如圖7所示之植入材料1 2係變換基質之形狀者，基質 6於內側形成有具有空洞6a(剖面爲圓形空洞）的圓筒體形 狀，在其兩端面各配置有一個大圓形空洞的入口 6b，於外 周面有小長圓形空洞的入口 6b，以形成交錯狀多數配置 著。然後，在此基質6的空洞6a裝塡有上述有機-無機複 合多孔體1，自形成於基質6的兩端面及外周面的各入口 6b部份露出著多孔體1。 此類植入材料1 2係如圖示般以縱向的姿勢插入頸椎及 46 326\總檔\91 \91134292\91134292(替換)-2 1252112 腰椎等椎體之間，與上述植入材料1 1同樣地，基質6或多 孔體1最後會與骨組織代換，使上下錐體癒合、固定。 又’因情況而異，亦可在此植入材料1 2的外周面形成公 螺絲’以橫向的姿勢旋入上下椎體間而設置。 圖8所示之植入材料亦爲變換基質形狀者，基質6係形 成爲具有曲率小的部分6n之高度低的環體形狀，於其內側 的空洞6a中裝塡有上述多孔體丨，自該空洞上下的入口讣 露出著多孔體1的上下兩面。在此環體形狀的基質6的外 周面’雖未形成有空洞的入口，但因應情況亦可形成多數 個空洞的入口。又，於此環體形狀的基質6的上下兩面， 亦可形成上述固定用的突起。 此類植入材料1 3係將基質6的曲率小的部分6n移往後 側’插入頸椎及腰椎等的椎體間，與上述植入材料丨丨、丄2 同樣地’基質6或多孔體1最後會與骨組織代換，使上下 椎體癒合、固定。 上述植入材料1 1、1 2、1 3，皆爲用以作爲椎體固定材以 插入、設置於頸椎或腰椎等椎體間者，若將基質6的形狀 適當變換，則亦可使用於各部位的骨關節中。 圖9所示之植入材料丨4係作爲同種移植骨片或自身移植 骨片的代替物，爲埋入骨缺損部位者，具有塊狀的有機-無機複合多孔體1與活體內可生物降解/吸收之構材之表 皮層7，此表皮層7係疊合於多孔體1表面之一部份而合 爲一體。 塊狀的多孔體1係與上述有機-無機複合多孔體爲相同 47 326\總檔\91 \91134292\91134292(替換)-2 1252112 者’亦即，係在活體內可生物降解/吸收之聚合物中，實質 上均一分散著具生物活性之生物陶瓷粉狀顆粒所成之活體 內可生物降解/吸收的多孔體，爲具有連續氣孔，且於氣孔 內面或氣孔內面與多孔體表面有露出生物陶瓷粉狀顆粒之 部份者。此多孔體1可藉由上述之本發明之製造方法來製 作’其氣孔率、連續氣孔的孔徑、連續氣孔佔氣孔整體的 比例、活體內可生物降解/吸收之聚合物、生物陶瓷粉狀顆 粒、該粉狀顆粒的含有率等均如上所述。 由於此多孔體1可發揮海綿骨的作用，其形狀只要是塊 狀皆可，並無特別限定，可針對應塡補之骨缺損處而製成 各種形狀。可使此多孔體1適量含有上述的骨形成因子、 成長因子、藥劑等，又，亦可在多孔體1的表面或表皮層 7的表面，施以上述氧化處理以改善濕潤特性。 表皮層7可發揮皮質骨的作用，係由含有具生物活性之 生物陶瓷粉狀顆粒之活體內可生物降解/吸收之聚合物所 構成之緻密質具強度的層。於此植入材料1 4中，可將表皮 層7豐合在塊狀的多孔體1的具凸彎曲之側面而一體設 置’亦可疊合設置於多孔體1的其他側面、上面、底面之 任一者上，又’亦可疊合設置於多孔體1的二面乃至於三 面以上。重點在於，此表皮層7只要疊合設置於塊狀的多 孔體1的表面之一部份上即可。 表皮層7的厚度，並無特別限定，就埋設植入材料} 4 之骨缺損部位而加以考量，以適當設定於1.0〜5· 〇mm的範 S內爲佳。右較1 · 0 m m薄，則有導致表皮層7的強度不足 326\總檔\91\91134292\91134292(替換)-2 48 1252112 的顧慮，若較5 · 0 m m厚，則會產生表皮層7被分解吸收並 與骨組織代換須要長時間的不良情形。 由於此表皮層7須要求有較塊狀多孔體1大的強度，作 爲原料的活體內可生物降解/吸收之聚合物，以使用結晶性 的聚乳酸或聚羥基乙酸等爲佳，尤其以使用黏度平均分 子量爲15萬以上（20萬〜60萬左右更佳）的聚-L-乳酸的具高 強度的表皮層7爲佳。 作爲該表皮層7所含有之生物陶瓷粉狀顆粒，上述多孔 體1所含有之具生物活性之生物陶瓷粉狀顆粒均可使用， 其含有率以作成爲1〇〜6〇重量％的範圍爲佳。若超過60重 量％，則表皮層7會脆弱化，若低於1 〇重量％，則會產生 因生物陶瓷粉狀顆粒之骨傳導形成不充分的不良情形。 此表皮層7係可將含有生物陶瓷粉狀顆粒之活體內可生 物降解/吸收之聚合物進行射出成形、或將含有生物陶瓷粉 狀顆粒之活體內可生物降解/吸收之聚合物的成形塊狀物 進行切削加工等的方法來製作。於後者的方法中，將成形 塊狀物以壓縮成形或鍛造成形等手段，使聚合物分子或結 晶進行配向作成塊狀物，將其切削加工所得的表皮層7， 由於質地緻密且聚合物分子或結晶成三維配向而使強度更 加提高，故佳。此外’將經延伸成形之成形塊狀物進行切 削加工所得之表皮層亦可使用。 此植入材料1 4係將以上述方法製作之表皮層7疊合在塊 狀多孔體1的具凸彎曲的一側面，經由熱融合等手段，作 成不可分離的合體。將表皮層7與多孔體1 一體化之手段 49 3 26\總檔\91 \91 ] 34292\91134292(替換)-2 1252112 係非限定於熱融合法’亦可經由其他手段進行一體化。 將上述構造的植入材料1 4，作爲同種移植骨片或自身移 植骨片的代替物，埋入骨缺損部位，將骨缺損部位的海綿 骨部位以塊狀多孔體1塡補，並將骨缺損部位的皮質骨部 位以表皮層7補償，則因塊狀多孔體1發揮海綿骨的作用， 強度大的表皮層7發揮皮質骨的作用，正如使骨缺損部位 的海綿骨部分以海綿骨塡補，皮質骨部分以皮質骨塡補一 般。 如此般將骨缺損部位以植入材料1 4塡補，則於塊狀多孔 體1，體液透過連續氣孔浸透到內部，於快速進行水解之 同時，經由生物陶瓷粉狀顆粒的骨傳導能，骨芽細胞會侵 入多孔體1的內部使骨組織可傳導形成。因此，塊狀多孔 體1可在較短期間內與骨組織代換。另一方面，表皮層7 較塊狀多孔體1慢，自表面開始慢慢地進行水解，於塊狀 多孔體1與骨組織代換至某程度的期間內，可維持充分的 強度，最後與骨組織代換而消失。此植入材料1 4係無上述 般的特異活體反應，而在非特異地分解、吸收、排出之途 中，可經由周圍之活體骨侵入、代換而變成自身骨者。亦 即，塊狀多孔體1與表皮層7皆被分解吸收而代換成骨組 織，由於不會作爲異物而殘留在活體內，故習用的陶瓷製 植入材料所掛慮的因活體內的長期殘存之危害性的發生之 顧慮得以去除，藉由經代換的自身骨組織，可將骨缺損部 位修復與重建。 又，此植入材料1 4係因多孔體1及表皮層7皆爲以活體 50 326\總檔\91\91134292\91134292(替換)-2 1252112 內可生物降解/吸收之聚合物作爲原料者，故不若以死體骨 作爲原料之習用的同種移植骨片般，㈣料獲得不足的顧 慮，可依需要而無限制地量產必要且充分量的植入材料， 經由成形及切削加工等，可製作成所要的形狀及尺寸。 又，此植入材料1 4的表皮層7，雖含有生物陶瓷粉狀顆 粒，但由於爲由活體內可生物降解/吸收之聚合物所構成 者’故k有燒結之陶瓷製植入材料般的過硬且脆的缺點， 爲具初性不易裂開之物’必要時亦可加熱變形。而且，塊 狀多孔體1雖也含有多量的生物陶瓷粉狀顆粒物，但因係 以活體內可生物降解/吸收之聚合物作爲原料之多孔體，故 即使氣孔率咼，不若高倍率的多孔質陶瓷般之非常脆，埋 入時不會零零落落地破片剝落，必要時亦可加熱變形。本 發明之植入材料1 4係無脆度、有充分實用強度，且亦可加 熱變形，爲使用性優異者。 又’此植入材料1 4可作爲外科用代替品使用於多用途， 尤其現在頓時受到使用作爲若干問題已得明朗化之頸椎及 腰椎的補綴材及間隔材方面甚爲有效。 圖1 〇及圖1 1所示之植入材料1 5係以使用於頭蓋骨、 顎、顏面部或胸部等之多種骨骼部位的缺損或變形部位的 修復、橋正或增大爲目的之作爲補綴、塡充材等之植入材 料’具備有機-無機複合多孔體1與爲活體內可生物降解/ 吸收之構材之網狀體8，在此網狀體8的網眼8 a中充塡有 多孔體1，而作成一體。 此植入材料1 5的網狀體8係由含有具生物活性之生物陶 51 3 26\總檔\91 \91134292\91134292(替換)-2 1252112 瓷粉狀顆粒的活體內可生物降解/吸收之聚合物所構 緻密質的具強度之網狀體’對含有生物陶瓷粉狀顆粒 體內可生物降解/吸收之聚合物的片狀物或板狀物用 或切削加工等手段形成方形網眼8 a而作成網狀體。 8 a的形狀，並不限定於方形’亦可作成圓形、菱形及 所要的網眼形狀。 網眼8a的開口面積係以0.1〜1.0cm2左右爲佳，網 佔網狀體8的面積比例以1 0〜8 0 %左右爲佳。又，網取 的厚度以〇 . 3〜1. 5 mm左右爲佳，網狀體8的相當於縱 分8 b及相當於橫紗部分8 c的寬度以2〜1 0 m m左右爲 網眼8 a的面積比例若未滿1 0 %，則植入材料1 5的整 度雖大，但因充塡於網眼8 a之水解速度快之多孔體1 塡量較少，水解慢的網狀體8所佔的比例變大，故植 料1 5完全被分解吸收而與骨組織代換所要的時間 長。另一方面，網眼8 a的面積比例若超過8 0 %、網形 的厚度較0.3mm薄、相當於縱紗部分8b及相當於橫 分8c的寬度較2mm狹窄，則由於網狀體8的強度會 甚多，故難以得到強度大的植入材料1 5。 於欲得到折曲加工性良好的網狀體8的情況，作爲 作爲材料之上述片狀物或板狀物，亦可使用將含有生 瓷粉狀顆粒之活體內可生物降解/吸收之聚合物的熔 形體’於低溫範圍（由聚合物的玻璃轉移溫度至熔融溫 的溫度範圍）進行鍛造之後，更進一步改變方向（機械 MD)進行鍛造者，對其進行打孔或切削加工等作成網丨 326\總檔\91\91134292\91134292(替換)-2 成的 的活 打孔 網眼 其他 眼8a (體8 紗部 佳。 體強 之充 入材 會變 t體8 紗部 降低 用以 物陶 融成 度間 方向 1良8 a 52 1252112 以製作網狀體。如此之改變方向進行2次鍛造之活體內可 生物降解/吸收之聚合物的片狀物或板狀物，由於活體內可 生物降解/吸收之聚合物的分子鏈、分子鏈集合之區域 (domain)、結晶等係多軸配向或成爲多軸配向的叢集 (cluster)所多數集合的構造，故若於常溫區域（〇〜5 )使其 折曲變形’則維持其形狀於體溫附近（30〜40 〇c )將難以恢復 成原來形狀’即使令其多次折曲變形，也不易白化或切斷。 因此’使用於此片狀物或板狀物上形成網眼8 a的網狀體8 所製作的植入材料1 5，係因折曲加工性良好，故如圖12 所示般’可於手術中在常溫下，以將與頭蓋骨20的缺損部 分21的曲面吻合的方式進行折曲加工，並固定於該缺損部 分2 1上。又，作爲網狀體8的材料之片狀物或板狀物，當 然亦可使用單軸或二軸延伸者、無延伸者或壓縮成形者。 作爲網狀體8的原料之活體內可生物降解/吸收之聚合 物，以經確認安全性的結晶性的聚-L_乳酸、聚-D-乳酸、 聚-D/L-乳酸、聚羥基乙酸等爲佳。就網狀體8的強度及水 解速度等考量之，此等活體內可生物降解/吸收之聚合物係 以使用黏度平均分子量爲15萬以上者爲佳，而以20萬〜60 萬程度者更佳。 作爲於此網狀體8的活體內可生物降解/吸收之聚合物 所含有的生物陶瓷粉狀顆粒，上述於多孔體1所含有的具 生物活性之生物陶瓷粉狀顆粒均可使用，其含有率以作成 爲10〜60重量％爲佳。若未滿10重量％，則因生物陶瓷粉 狀顆粒之骨傳導形成會不充分，若超過60重量％，則會發 326\總檔\91\91134292\91134292(替換)·2 53 1252112 生網狀體8脆弱化之不良情形。 又，亦可使用例如將含有生物陶瓷粉狀顆粒的活體內可 生物降解/吸收之聚合物的縱紗與橫紗的交點融合之網狀 體等來代替上述網狀體8。 另一方面，充塡於上述網狀體8的各網眼8 a之多孔體1 係與上述有機-無機複合多孔體爲相同者，亦即，係在活體 內可生物降解/吸收之聚合物中，實質上均一分散著具生物 活性之生物陶瓷粉狀顆粒所成之活體內可生物降解/吸收 的多孔體，爲具有連續氣孔，且於氣孔內面或氣孔內面與 多孔體表面有一部份的生物陶瓷粉狀顆粒露出者。此多孔 體1的氣孔率、連續氣孔的孔徑、連續氣孔佔氣孔整體的 比例、活體內可生物降解/吸收之聚合物、生物陶瓷粉狀顆 粒、該粉狀顆粒的含有率等均如上所述。 於此多孔體1中’亦可適量含有上述的骨形成因子、成 長因子、藥劑等，又’亦可在多孔體1的表面或網狀體8 的表面，施以上述氧化處理以改善濕潤特性。 上述構造的植入材料1 5係如圖1 2所示般，以將頭蓋骨 20的缺損部分21覆蓋的方式緊靠貼在頭蓋骨2〇上，其周 緣部以由活體內可生物降解/吸收之聚合物所構成之螺絲 3 0作數處固定。此時，以與頭蓋骨2 〇的缺損部分2丨的曲 面吻合之方式，將植入材料1 5作折曲加工爲佳。 如此地將頭蓋骨20的缺損部分2 1以植入材料1 5覆蓋， 則網狀體8經由與液體的接觸，自表面開始會慢慢地進行 水解’多孔體1則因體液會透過連續氣孔浸透到內部，故 326\總檔\91 \91134292\91134292(替換)·2 54 1252112 水解會快速進行。然後，經由多孔體1所含有的生物陶瓷 粉狀顆粒的骨傳導能，骨芽細胞會侵入到多孔體1的內 部’使骨組織傳導形成，而使多孔體1在較短期間內代換 爲骨組織。另一方面，網狀體8較多孔體1緩慢地進行水 解’多孔體1在骨組織達到一定程度的代換之前的期間， 可維持充分強度以保護頭蓋骨20的缺損部分2 1。最後， 網狀體8亦與骨組織代換而消失。 此植入材料1 5係如上述般，多孔體丨與網狀體8皆被分 解、吸收而代換爲骨組織，因並非作爲異物而殘留在活體 @ ’故可一掃習用之作爲骨缺損部的補綴材所使用之衝孔 丰反’在活體內長期存在之危害性的發生之顧慮，並可經由 代換的骨組織將頭蓋骨20的缺損部分2 1修復、重建。 又’此植入材料1 5的網狀體8，雖含有生物陶瓷粉狀顆 粒’爲由活體內可生物降解/吸收之聚合物所構成者，但無 經由燒結之緻密的陶瓷般的過硬且脆的缺點，爲具韌性且 不易裂開之物，於常溫下可加熱變形。而且，多孔體1雖 亦含有多量的生物陶瓷粉狀顆粒物，由於係將活體內可生 物降解/吸收之聚合物作成矩陣者，故即使氣孔率高，不若 高倍率的多孔質陶瓷般之非常脆，埋入時不會零零落落地 破片剝落，必要時亦可加熱變形。如此之本發明之植入材 料1 5係不具脆度而具有充分實用強度且亦可加熱變形之 使用性優異者。 此植入材料1 5係藉由將發揮具強度的皮質骨之作用之 部分作成網狀體，及將發揮海綿骨之作用之多孔體作成高 55 326\總檔\91\91134292\91134292(替換)-2 1252112 空隙率’而可得到高面積且少材料的活體骨的代替物，爲 由網狀體與多孔體的組合，使材料總量限制爲極少量，於 分解吸收過程中，活體的處理量甚少的活體適合性優異的 植入材料。 又’此植入材料1 5係除了圖1 2所示之使用例之外，亦 可使用於顏面中的塌陷骨折的補塡、骨腫瘍等之病巢之摘 除後的塡補等、較大骨缺損部位的修復與重建，且亦可作 爲骨延長用的基材。 於將上述多孔體1與網狀體8組合的型態之植入材料i 5 中’不只是將多孔體1充塡到網狀體8的網眼8 a中，於網 狀體8的單面或兩面亦有將多孔體1設置爲層狀的構造， 爲甚有用的實施形態。圖1 3、圖1 4係顯示此類實施形態 之植入材料16，17,植入材料16係在上述植入材料15之單 面上’將上述有機-無機複合多孔體1設置爲層狀者，植入 材料1 7係在植入材料1 5的兩面，將上述有機-無機複合多 孔體1設置爲層狀者。 層狀多孔體1係與上述有機-無機複合多孔體1爲相、同 者’爲藉由上述本發明之製造方法製作成層狀（片狀）者。 此層狀的多孔體1係可經由熱融合等手段在植入材料i 5 的單面或兩面上進行積層爲一體。此層狀多孔體1的厚度 並無特別限定，就與骨缺損部位周圍的骨之密合性、或分 解吸收及與骨組織之代換所要的時間等考量之，以設定爲 0.5〜3mm左右的厚度爲佳。 此類植入材料1 6，1 7係因可在較短期間內，於單面或兩 56 3 26\總檔\91 \91134292\91134292(替換)·2 1252112 面上均等地形成骨組織，故骨缺損部位表面之修復、重建 可快速進行。又’設置爲層狀的多孔體1係因可發揮作爲 緩衝材的作用’密合於骨缺損部位周圍的骨上，骨芽細胞 容易侵入層狀多孔體i的內部，故可較早的使骨組織傳導 形成於多孔體1的表層部，植入材料1 6，丨7與骨缺損部位 周圍的骨會直接結合，而可強固地固定。 又’於將上述多孔體1與網狀體8組合所成之型態的植 入材料1 5中，將網狀體8作成凹曲或凸曲，於其內側亦以 多孔體1充塡之構造者，亦爲有用的實施形態。圖1 5係顯 示此類實施形態之植入材料1 8，此植入材料1 8係使上述 植入材料1 5的網狀體8凹曲成U字形，與充塡於其網眼 中之多孔體1同樣地，將多孔體1亦充塡於網狀體8的內 側（即凹曲內部）。作爲網狀體8，以對改變機械方向進行二 次鍛造之上述折曲加工性良好的活體內可生物降解/吸收 之聚合物之片狀物或板狀物，形成網眼而製作的網狀體， 其機械強度高且可在常溫下進行折曲加工，故特佳。 此類植入材料1 8係例如製作成可埋入、充塡於顎骨等缺 損部位的大小，如圖1 2中以虛線所示般地，可使用於顎骨 的缺ί貝部位的修復、重建。此外，當然可使用於以因事故 或癌症所失去的活體骨的塡補、再生爲目的之頭蓋骨、中 間顏面、上顎或下顎等顎顏面的缺損部分，而於整形外科 方面之其他較大骨缺損部分的修復、重建亦適用。 又’上述植入材料1 8，雖爲將網狀體8凹曲成U字形， 但可依應重建之骨缺損部位之吻合的形狀，將網狀體8凹 3 2 6\總檔\91 \91134292\91134292(替換)-2 57 1252112 曲或凸曲，在其內側充塡多孔體1而製作成植入材料i 8 即可，因應情況，亦可在植入材料1 8的外側，將多孔體i 進一步設置爲層狀。又，亦可作成將網狀體8折疊，於折 疊之網狀體8間亦以多孔體丨充塡的構造之植入材料，再 者’亦可作成將植入材料1 5上下兩片疊合，於其間夾入層 狀多孔體1的三明治構造的植入材料。 圖1 6及圖1 7係顯示人造軟骨用的植入材料丨9。此人造 軟骨用植入材料1 9係具備上述有機-無機複合多孔體1、 爲活體內非吸收性構材之芯材9、爲活體內可生物降解/吸 收之構材之固定用軸釘22，多孔體1係合體般地積層於活 體內非吸收性構材的芯材9之上下兩面，固定用軸釘2 2 的前端係自多孔體1的表面突出。 此人造軟骨用植入材料1 9係具有如圖1 6所示般的結合 長方形與半圓形之大約前方後圓形狀的平面形狀的區塊 狀，爲可適用作爲人造椎間板者。 芯材9係將有機纖維作成爲三維織組織或編組織或此等 複合組織之組織構造體所構成者，具有與椎間板等軟骨同 程度之機械強度與柔軟性，變形係活體模仿性（b i 〇 m i m e t i c s) 者。此芯材9的組織構造體係與本案申請人已提出申請之 曰本專利特願平6 -25 4 5 1 5號中所記載之組織構造體爲同樣 者，當將其幾何形狀以維數來表示，將纖維排列的方位數 以軸數來表示，以採用3軸以上的多軸-三維組織所構成之 構造體爲佳。 3軸-三維組織係將縱、橫、垂直3軸的方向之纖維進行 58 326\總檔\91 \91134292\91134292(替換)-2 1252112 立體性組織者，其構造體的代表性形狀爲如上述芯材9般 的具厚度之區塊狀（板狀乃至於塊狀），亦可作成圓筒狀或 蜂巢狀。此3軸-三維組織係依組織的不同，可分類爲正交 組織、非正交組織、交互連接組織、圓筒組織等。又，4 軸以上的多軸-三維組織的構造體，藉由排列4,5,6,7,9,^ 軸等的多軸方位，可提高構造體之強度的等方向性。而且， 經由此等選擇，可得到更酷似活體的軟骨組織、更活體模 仿性的芯材。 由上述組織構造體所構成之芯材9的內部空隙率，以 2 0〜9 0 %的範圍爲佳，於低於2 0 %的情況，由於芯材9變得 緻密而會損及柔軟性或變形性，故爲無法滿足作爲人造軟 骨用植入材料的芯材，又，於高於90%的情況，由於芯材 9的壓縮強度或保形性降低，終究不適於作爲人造軟骨用 植入材料的芯材。 作爲構成芯材9之有機纖維，可使用活體非活性的合成 樹脂纖維，例如聚乙烯、聚丙烯、聚四氟乙烯等纖維；以 使用將有機的芯纖維以上述活體非活性的樹脂覆蓋，作成 活體非活性的覆蓋纖維等爲佳。尤其是，將超高分子量聚 乙烯的芯纖維（捻紗）以直鏈狀的低密度聚乙烯的被膜覆蓋 之直徑爲0.2〜0 · 5 m m左右的覆蓋纖維，就強度、硬度、彈 性、編織的容易度等而言，爲最佳纖維。又，亦可選擇其 他有生物活性（例如，具有骨傳導或誘導能）的纖維。 又，用以構成芯材9的組織構造體，由於已在上述日本 專利特願平6 - 2 5 4 5 1 5號中有詳細揭示，故將說明省略。 59 326\總檔\91\91134292\91134292(替換)·2 1252112 積層於芯材9上下兩面的多孔體1係與上述有機-無機複 合多孔體爲相同者，亦即，係在活體內可生物降解/吸收之 聚合物中，實質上均一分散著具生物活性之生物陶瓷粉狀 顆粒所成之活體內可生物降解/吸收的多孔體，爲具有連續 氣孔，且於氣孔內面或氣孔內面與多孔體表面有一部份的 生物陶瓷粉狀顆粒露出者。此多孔體1係藉由上述本發明 之製造方法所製作，其氣孔率、連續氣孔的孔徑、連續氣 孔佔氣孔整體的比例、活體內可生物降解/吸收之聚合物、 生物陶瓷粉狀顆粒、該粉狀顆粒的含有率等均如上所述。 此多孔體1爲具有作爲間隔物的作用者，當此多孔體1 積層於芯材9的兩面，則於將此植入材料1 6插入於頸椎或 腰椎等椎體間（參照圖6的頸椎C3-C4或腰椎L4-L5)時，多 孔體1因上下椎體之夾壓力而壓縮變形，呈無縫隙地與椎 體密合，隨著與體液的接觸之多孔體1的水解，骨組織經 由生物陶瓷粉狀顆粒物的骨傳導能，可傳導形成到多孔體 1的內部，在較短期間內多孔體1會與骨組織代換，而與 椎體及芯材9直接結合。此時，對芯材9的表面噴吹生物 陶瓷粉狀顆粒物，作成生物活性化的表面層’則由於經傳 導的活體骨會結合到此經活性化的表面層’故椎體與芯材 9的直接結合可在較短期間內進行，強度亦可保持。再者’ 使骨誘導因子含有於此多孔體1中’則可發揮骨誘導性而 更有效果。 此多孔體1的厚度以作成爲〇·5〜3mm左右爲佳，於較 0.5 mm薄的情況，由於難以吸收因壓縮變形之椎體表面的 60 326\總檔\91 \91134292\91134292(替換)-2 1252112 凹凸’故與椎體的密合性有降低的顧慮，反之，於較3mm 厚的情況，分解吸收及與骨組織的代換所要的時間較長。 又’此多孔體1係如圖1 7所示般，以使其厚度的大約一半 埋入芯材9中的方式進行積層，使多孔體1以將芯材9的 周緣部圍住爲佳，如此作法可抑制多孔體1周緣的磨損。 又’此多孔體1中，亦可適量含有上述的骨形成因子、 成長因子、藥劑等，此情況係可顯著促進於多孔體1內部 的骨形成，芯材9與椎體之直接結合可較早發揮效果。又， 亦可在多孔體1的表面，施以上述氧化處理以改善濕潤特 性’使應增殖之骨芽細胞的侵入、生長更有效果。 固定用軸釘2 2係貫通上述芯材9與其兩面的多孔體1， 其兩前端則自多孔體1突出。有此類固定用軸釘22，則於 將此植入材料1 9插入上下的椎體間時，藉由上下的椎體的 夾壓力’自多孔體1突出的固定用軸釘22前端會深入椎體 的接觸面’故植入材料1 9可固定於椎體間而不會發生位置 偏移的情形。 固定用軸釘2 2的支數以2支以上爲佳，最佳的支數爲圖 示般的3支’此情況係有經由3點支撐而可安定地安裝到 上下的椎體間之優點。固定用軸釘22的兩前端係以形成爲 圓錐狀等之尖的形狀爲佳，又，軸釘2 2的直徑係爲確保強 度而以1〜3mm左右爲佳。再者，固定用軸釘22兩前端的 突出尺寸’以0.3〜2mm左右爲佳。 於將植入材料1 9插入椎體間之最初，由於會由上下的椎 體的夾壓力對固定用軸釘2 2作用，故強度大的固定用軸釘 61 326\總檔\91 \91134292\91134292(替換)-2 1252112 係屬必要。因此，此固定用軸釘22係以使用黏度平均分子 Μ爲1 5萬以上（2 0萬〜6 0萬程度更佳）的結晶性之聚乳酸及 聚控基乙酸等活體內可生物降解/吸收之聚合物製造爲 佳，又，以使用對此等聚合物以具生物活性之生物陶瓷粉 狀顆粒混合者亦佳。又，配合需要亦可藉由壓縮成形、鍛 造成形、延伸等方法，使聚合物分子配向以提高強度。 將上述構造的人造軟骨用植入材料丨9，作爲人造椎間板 安裝到上下的椎間板，則如上所述般，因自多孔體1的表 面突出之固定用軸釘2 2的兩前端會深入椎體的接觸面，故 植入材料1 9可固定於椎體間而不會發生位置偏移的情 形。因此，不須用補助固定具等來固定活體材料，故可容 易進行手術。而且，當如此般地將植入材料1 9安裝到椎體 間，則芯材9表面的多孔體1會因上下的椎體的夾壓力而 被壓縮，呈無縫隙地與椎體密合，隨著多孔體1的分解吸 收之進行，骨組織會傳導形成到多孔體1的內部，多孔體 1會在較短期間內與骨組織代換而與椎體及芯材9直接結 合。然而，由於芯材9爲活體非活性的合成樹脂纖維，故 骨組織不會傳導形成到其內部，而可維持著柔軟性。此芯 材9係如上所述爲將有機纖維作成爲3軸以上的多軸-三維 織組織或編組織或此等複合組織之組織構造體所構成者， 故具有與椎間板等軟骨同程度之機械強度與柔軟性，且變 形較容易，故可行使與椎間板大致相同的行爲而發揮椎間 板的作用。然後，固定用軸釘2 2亦可在較短期間內被分解 而吸收於活體，故不會殘留。 62 326\總檔\91\91134292\91134292(替換)-2 1252112 如上述般，此人造軟骨用植入材料1 9係芯材9爲利用活 體模仿性，使其舉動酷似軟骨組織，且具備與椎體骨的骨 終板之直接結合能與初期自立性者，固定用軸釘2 2前端會 突刺到骨組織，可防止本身之橫向偏移與脫落，多孔體1 會與骨組織直接結合，可於組織學上呈一體化者。因此， 此植入材料1 9係可完全消除如上述習用的三明治構造之 自立型人造椎間板所具有的缺點。 又，上述人造軟骨用植入材料1 9上，係於芯材9的兩面 積層有多孔體1，將固定用軸釘22的兩前端自多孔體1突 出’但亦可作成在芯材9的單面積層以多孔體1，並使固 定用軸釘22之一的前端突出的構造。具此類構造的人造軟 骨用植入材料，由於可利用固定用軸釘22將其單面固定於 一方的椎體上，固定強度雖會降低，但可防止植入材料丄9 的位置偏移。又，亦可使多孔體1的厚度隨著由前面方形 部份往後面圓形部份接近而慢慢增大，若如此做，則上下 椎體間的空間部分’將形成爲前側較窄而後側較寬，故可 變爲完全吻合該空間部份而安裝之植入材料。又，因應情 況’亦能作成爲將短的固定用軸釘埋入於芯材9的表層部 中，將該軸釘前端自多孔體1突出的方式，以替代貫通的 固定用軸釘2 2。 以上，係就人造椎間板用的植入材料1 9所作的說明，但 無需多說的，係只要將其形狀適當地變換，即可作成爲人 造椎間板以外的半月板或各種關節軟骨用的植入材料。 以上’雖梦照特定的實施形態詳細地做了說明，彳日該所 326\總檔\91 \91134292\91134292(替換)-2 63 1252112 屬技術領域之業者應知，在不超出本發明的精神與範 內，可加以作各種變換或修正。 本申請案係依據200 1年11月27日提出申請的日本專 申請案（特願2001-360766)、2001年12月03日提出申請 日本專利申請案（特願2001-368558)、2002年02月20日 出申請的日本專利申請案（特願2002 _ 04 3 1 3 7 )、2〇〇2年 月23日提出申請的日本專利申請案（特願2002 -242 800) 2002年09月30日提出申請的曰本專利申請案（特 2002-285933)、2002年09月30日提出申請的日本專利 請案（特願2002-2 8 5 934)者，將其內容取用於此作爲參照 [產業上之可利用性] 本發明之植入材料係可實際使用作爲活體骨組織重 用的植基構造、補綴材、骨塡料、其他植入材料與骨組 之間的介在物、海綿骨的代替物、藥劑緩放用載體等。又 本發明之植入材料係與其他活體內可生物降解/吸收之 材及/或活體內非吸收性構材合成一體，而實際使用作爲 種骨固定用材、椎體固定材、各種活體骨間間隔物、骨 損部位塡補材、補綴材或塡充材、人造軟骨材等。 [圖式簡單說明] 圖1爲顯示本發明之植入材料之一實施形態的立體圖 圖2(a)、（b)、（c)爲同實施形態的植入材料之一使用例 說明圖。 圖3爲顯示本發明之植入材料的其他實施形態之立 圖。 326\總檔\91\91134292\91134292(替換)-2 圍 利 的 提 08 願 串 〇 建 織 y 構 各 缺 的 體 64 1252112 圖 4爲 同 實 施 形 態 之 植 入 材 料 的 基 質 之 體 圖 〇 圖 5爲 同 實 施 形 態 之 植 入 材 料 的 縱 剖 面 圖 〇 圖 6爲 同 實 施 形 態 之 植 入 材 料 的 一 使 用 例 的 說 明 圖 〇 圖 7爲 m 示 本 發 明 之 植 入 材 料 的 又 — 其 他 實 施 形 態 之 一〈了i 體 圖 〇 圖 8爲 m 示 本 發 明 之 植 入 材 料 的 又 一 其 他 實 施 形 態 之 立 體 圖 〇 圖 9爲 顯 示 本 發 明 之 植 入 材 料 的 又 一 其 他 實 施 形 態 之 體 圖 〇 圖 10 爲 顯 示 本 發 明 之 植 入 材 料 的 又 —. 苴 他 實 施 形 態 之 立體圖。 圖1 1爲同實施形態的植入材料的剖面圖。 圖1 2爲同實施形態的植入材料的一使用例之說明圖。 圖1 3爲顯示本發明之植入材料之另一其他實施形態之 剖面圖。 圖1 4爲顯示本發明之植入材料之另一其他實施形態之 剖面圖。 圖1 5爲顯示本發明之植入材料之另一其他實施形態之 剖面圖。 圖1 6爲顯示本發明之植入材料之另一其他實施形態之 立體圖。 圖1 7爲同實施形態之植入材料的剖面圖。 元件符號說明 1 多孔體 65 326\總檔\91\91134292\91134292(替換)-2 1252112 lb 入 □ 2 軸 釘 2a 凹 凸 3 鋼 線 4 收 束 帶 5 孔 6 基 質 6 a 空 洞 6b 空 洞 的 入 □ 6 c 基 質 的 、r · 刖 面 6d 基 質 的 上 面 6 e 基 質 的 下 面 6f 固 定 用 突 起 6g 凹 穴 6h 軸 釘 6i 壁 部 6 j 連 通 孔 6 n 曲 率 小 的 部 分 7 表 皮 層 8 網 狀 體 8a 網 眼 8b 相 當 於 縱 紗 部 分 8 c 相 當 於 橫 紗 部 分 9 心 材 3 26\總檔\91 \91134292\91134292(替換)-2 66 1252112 1 0〜1 9植 入 材 料 20 頭 蓋 骨 2 1 缺 損 部 分 22 固 定 用 軸釘 30 螺 絲 B 半 胸 骨 67 326V總檔\91\91134292\91134292(替換)-2BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an implant material composed of a bioactive and biodegradable/absorbable organic-inorganic composite porous body, a method for producing the same, and a method for producing the same, and An implant material composed of the composite porous body and other living materials. [Prior Art] As the inorganic porous body for medical use, for example, a porous ceramic obtained by calcining or sintering bioceramics is known. However, when the porous ceramic is used for the use of a plant-based structure or a patch material for reconstruction of a living bone tissue, although it is hard but brittle is a disadvantage, it is often caused by a slight impact after surgery. damage. Further, it is difficult to process and deform the shape of the porous ceramic at the time of surgery to conform to the defect portion of the living bone tissue. Furthermore, in order to completely replace living bones, it sometimes takes a long period of more than 10 years, so there are still many hazard concerns due to damage during this period. On the other hand, as an organic porous body for medical use, a sponge or the like disclosed in Japanese Laid-Open Patent Publication No. SHO63-649-8 is known. This sponge is usually used as a patching material for suturing at the time of surgery or suturing of living soft tissues (e.g., viscera, etc.), and is a sponge having continuous pores composed of polylactic acid which is biodegradable/absorbable in vivo. This sponge is produced by dissolving polylactic acid in benzene or dioxane, freezing the polymer solution, and sublimating the solvent. However, the porous body produced by the sponge-like freeze-drying method, 6 326\total file \91 \91134292\91134292 (replacement)-2 1252112, is required to be sublimated for a long time to completely remove the solvent, and its thickness is as thin as Below lmm (usually in the range of several hundred / / m), it is difficult to produce a porous body having a thickness of several mm or more. As another method of producing a porous body having continuous pores, various methods have been examined in addition to the freeze-drying method described above, but it is not easy to obtain a porous body having a thickness of several mm or more. Such a thin porous body shape is closely fitted to the complex and large three-dimensional space of the damaged portion of the living tissue, and can function as a temporary patch material. However, it is intended to be a reconstruction of the three-dimensional structure for the damaged portion. The material is not feasible. Therefore, it is desirable that the three-dimensional shape which is thick and can be finely processed into an arbitrary shape before or during surgery can be decomposed and absorbed relatively quickly to replace the living bone. Further, as another effective method for producing a continuous porous body, it is known that a plurality of soluble powdery particles of a predetermined amount of water-soluble NaCl or the like are mixed in a polymer to form a thin molded body such as a sheet. Immersed in water (solvent) to elute the powdery particles, thereby forming a continuous pore having the same pore diameter as the powdery particles. However, since it is difficult to completely dissolve the powdery particles, it is limited only to A continuous porous body of flakes. Further, if the proportion of the water-soluble powdery particles is not sufficiently high, continuous bubbles are less likely to be formed. Further, when the porous body is buried in the living body, there is a problem of the toxicity of the powdery particles remaining in trouble. A porous body which does not contain inorganic powdery particles such as biologically active bioceramics, as described above, lacks direct binding, conductivity, substitution, and the like to living bone tissues such as hard bone or cartilage. Invasion and interstitial of fibroblasts such as non-bone bud cells, therefore, it is necessary to replace the living tissue completely until the regeneration of the 326\total file\91\91134292\91134292 (replacement)-2 1252112, which takes a considerable period of time. Not even replaced. Therefore, the applicant of the present case has proposed in the past that the bone bud cells can be seeded as a three-dimensional cube planting structure for implanting a large bone defect site as a bridge and containing bioactive ceramic powder in the interior. An application for a porous body having a large pore size and a continuous pores, which is composed of a biodegradable/absorbable polymer in the living body (Japanese Patent Application No. Hei 8-229280). This porous system is produced by a method for producing a porous body called a solution precipitation method. That is, the biodegradable/absorbed polymer in the living body is dissolved in a mixed solvent of a solvent and a non-solvent having a higher boiling point than the solvent, and the bioceramic powdery particles are dispersed and dispersed into a suspension. The suspension volatilizes the mixed solvent at a low temperature relative to the boiling point of the solvent to precipitate a biodegradable/absorbable polymer in the living body coated with the bioceramic powder particles. The principle of formation of the porous body by the solution precipitation method is as follows. That is, since the mixed solvent volatilizes at a low temperature from the boiling point of the solvent, the solvent having a low boiling point is preferentially volatilized, and the proportion of the non-solvent having a high boiling point is gradually increased, when the solvent and the non-solvent reach a certain level. At the time of the ratio, the solvent can no longer dissolve the polymer. Therefore, the polymer begins to precipitate. Precipitation, the bioceramic powdery particles which initially settled are wrapped, and the precipitated and precipitated polymer shrinks and solidifies due to a high proportion of non-solvent, and is immobilized in the state containing the bioceramic powdery particles to form The thin cell walls of the joined polymer are constructed in a mixed solvent-filled state of the cell 8 326\total file \91\91134292\91134292 (replacement)-2 1252112. Thereafter, the remaining solvent is volatilized and disappeared in a state where the cell wall is broken, and the non-solvent having a high boiling point is also slowly volatilized through the pores to eventually evaporate and disappear. As a result, the residue of the mixed solvent surrounded by the cell wall of the polymer becomes a continuous pore, and a porous body containing the bioceramic powdery particles is formed. The above solution precipitation method is an excellent method for forming a porous body having a thickness from a low expansion ratio to a high expansion ratio, and a bulk three-dimensional porous body having a thickness of several mm or even several tens of mm can be obtained. . Therefore, it is useful to create a planting structure such as a bone regeneration having a three-dimensional shape (three-dimensional structure) having a large undulation. However, this method has the disadvantage that in the suspension containing a large amount of bioceramic powdery particles, the bioceramic powdery particles belonging to the larger particle size distribution in the particle size distribution start to settle after the solvent begins to volatilize, and are polymerized. When the material begins to precipitate and precipitate, there are already many bioceramic powder particles that settle toward the bottom with a concentration gradient, so the porous system obtained cannot avoid the content of the bioceramic powder particles is not uniform, from the upper surface of the porous body. The more the side is on the bottom side, the more it contains. Such a porous body having a heterogeneous content concentration gradient is not always effective and difficult to use for the use of a plant base structure, a patch material or a bone material for bone tissue reconstruction. This problem is controlled by some method to control the sedimentation velocity of the bioceramic powdery particles, so there is a certain degree of improvement, but it cannot be completely solved. In particular, it is not limited to the present method to produce a porous body for three-dimensional bone reconstruction in which a homogeneous and uniform concentration of 30% by weight or more of bioceramic powder particles is used, and it is generally difficult. 9 326\总档\91 \91134292\91134292 (replacement)-2 1252112 The porous ceramic body of the bioceramic powdery particles produced by the above method is mostly composed of the cell wall of the polymer. It is difficult to be exposed to the inner surface of the continuous pore or the surface of the porous body. Therefore, when it is buried in the living body, it is difficult to exhibit the conduction of the living bone tissue due to the bioceramic powdery particles immediately after the implantation. It is necessary to be exposed to the decomposition of the polymer used to form the skin layer, and the problem of biological activity is exerted after time lag. Further, in the porous body produced by the above method, even if fine powdery particles are selected as the bioceramic powdery particles, the content thereof is not more than about 30% by weight, and if it is contained in a larger amount, the living body The ceramic powder particles are more likely to settle, so that the bottom side of the obtained porous body contains a large amount of bioceramic powder particles and becomes extremely brittle. Further, in the porous body produced by the above method, generally, the proportion of continuous pores is as high as 80% or more, but in general, the pore diameter is only relatively small in the number of / / m or even tens / / m Since the continuous pores are difficult to say, it is difficult to form a pore shape or a pore shape which is ideal for invasion and growth of bone bud cells inside the porous body. A method for subjecting the inorganic powdery particles to high enthalpy is also examined by a method different from the solution precipitation method of the applicant of the present invention, and one of the useful methods is that the polymer is filled with about 50% by weight of the living body. A method of producing a continuous porous body by firing a particle of ceramic powdery particles by heating the particles to a surface fusion method. This method is not a novel method and is known, for example, as a method for producing a porous body as a particulate resin such as an epoxy resin or a vinyl chloride resin. This method is because the surface must be melted 10 326 \ total file \91 \91134292\91134292 (replace) - 2 1252112, so the charge has its limit, because more than 50% by weight of the charge will become brittle, so it is difficult. And the control of the pore diameter is not easy, and it is difficult to obtain good quality. SUMMARY OF THE INVENTION An object of the present invention is to provide various implant materials comprising an organic-inorganic composite porous body which is highly entangled with inorganic particles and which can solve the above problems, and a method for producing the same. Further, it is an implant material composed of a combination of the organic-inorganic composite porous body and other living materials; and the object thereof is to provide a bone fixation material user as a bone fixation material (intervertebral preparation material, vertebral body reinforcement material) Or a user, a user who is a substitute for a homologous bone graft or a self-transplanting bone piece, a cortical bone, a sponge bone, or a combination thereof, a user who is a complement or a deformed part of a bone defect, or a user, The user is a plant-based structure that forms hard and cartilage, and is used as a user of artificial cartilage. Nowadays, as a bone fixation material, for example, in a surgery for incision and occlusion of the sternum, a fixation composed of a biodegradable/absorbable polymer embedded in the intramedullary canal as a bridge in the incision on both sides of the incision of the sternum is used. Shaft nails. This system is slowly disintegrated and absorbed in the sternum, so there is no advantage of non-absorbent ceramic or metal shaft nails that require surgery to remove it from the body. 'But because there is no bone conduction and it will not The bone tissue is directly bonded, and can only function as a wedge, and has only the effect of temporarily fixing the sternum that is locked to lock the incision surface. Therefore, as seen in most of the sternum of the elderly, 'only the sponge bone remains, and only the thin cortical bone remains and becomes thin and brittle. Even if the sternum is embedded with a fixed shaft, It is also difficult to fully exert the role of "wedge" to improve the stability of fixation, and there is a problem that it does not replace bone tissue. On the other hand, the ceramic porous system such as hydroxyapatite (HA) used for the joint fixation of the broken bone or the fracture site other than the sternum 11 326 \ total file \91 \91134292\91134292 (replacement)-2 1252112 is easy. It takes a long time to crack and to be absorbed in the living body. There are also insights that even if it takes a long time, as long as it is buried in the living bone, the strength can be restored without being a problem, but the damage to the entire period of burial has its concerns. The implant material used as the bone fixing material of the present invention is intended to solve such problems. However, the conventional vertebral fixation material, for example, a titanium or carbon cage used as a spacer between the vertebral bodies in the intervertebral body fixation before lumbar vertebral lesions, can satisfy the surface. Chemical in vivo affinity, but the physical affinity of the living body is different from the living body. Therefore, as a foreign body remains for a long time, there will be problems of damage and corrosion caused by time and damage to surrounding tissues. There are also problems such as the inconsistency of the mechanical properties of the cage and the living body, and the end-plate exposed by the reaming causes the cage to settle in the vertebral body. In particular, the carbon frame is hard and brittle, so it is destroyed along the carbon fiber, and sometimes even fragments are generated. Therefore, the fear of its occurrence has always existed. In addition, the bones used for the transplantation of these cages are usually supplied by the intestines, and the number of them is obtained, and the treatment after the extraction is complicated (the post-treatment of the extracted parts and the intestines) The problem of crushing of bone, filling of the cage, disposal under aseptic, etc.). The implant material used in the present invention as a vertebral body fixing material or the like is mainly intended to solve such problems. On the other hand, the surgical system that cuts the bone of the deceased, processes the same kind of bone graft, or extracts the bone graft from the larger bone part such as the pelvis and the rib to repair the bone defect. By. Allograft bone system 12 326\总档\91 \91134292\91134292 (replacement)-2 1252112 As long as it is an integrated block with cortical bone on the surface of the sponge bone, the cortical bone of the bone defect site can be In part, the cortical bone of the bone piece is filled, and the sponge bone part of the bone defect part is filled with the sponge bone of the bone piece. However, in the case of the same kind of bone graft, since the bone of the deceased is cut and processed, it is necessary to obtain a large amount of the bone of the deceased as a raw material, and it is not easy to provide a sufficient bone graft, and the shape that can be processed is also greatly limited. The problem. Moreover, although it is a bone graft of the same kind, the bone piece to be transplanted is a bone tissue different from the bone tissue itself, and is based on the embedding condition, or has been eliminated due to natural absorption, or has insufficient strength or reduced strength. . In addition, sterilization treatment is necessary because of the bones of others, and the bones will be modified based on the treatment conditions, so control of sufficient sterilization conditions is necessary. However, when the time or treatment is inadequate, there is also a serious accident between the time of burial and death. Although the transplanted bone pieces taken during the operation can avoid such accidents, there is no denying the shortage of the number. On the other hand, an implant material made of ceramics such as hydroxyapatite (HA) or tricalcium phosphate (TCP) is also implanted in the bone defect site, but this is the cortical bone portion and the sponge bone of the bone defect site. Some of them are supplemented by the same hard ceramics, and since the ceramics remain semi-permanently, there is a problem that the bone defect cannot be reconstructed with its own bone tissue. Therefore, the method of producing a porous ceramic to replace the sponge bone has become quite practical. However, it is desirable to replace the living bone with such synthetic artificial bone. Since it is necessary to replace it for a long period of time after 10 to 20 years, it is necessary to pay attention to the accident as a physical foreign matter. The implant material used in the present invention as a substitute for the same type of bone graft and self-transplanted bone sheet is mainly intended to solve such problems. 13 326\总档\91 \91134292\91134292 (replacement)-2 1252112 Further, as a conventional bone defect or deformation part, the patch, the sputum, and the covering material are formed by punching. There are a perforated flat plate or a embossed plate made of a metal punched (mesh) plate of a large number of holes, or a dense body or a porous body of a sintered bioceramic. However, the metal perforated plate lacks the physical affinity of the living body, and it remains as a foreign matter in the replenishing part. Therefore, there is concern that the corrosion of the surrounding tissue is caused by corrosion or metal ion elution in the long-term embedding. And there is the problem that the defect site can never be completely replaced by the bone tissue. Further, the porous body of the sintered bioceramic is hard and brittle and is easily broken, and there is a concern that the impact is broken during use, and there is a problem that it cannot be formed after the surgery in accordance with the three-dimensional shape of the bone defect portion. The implant material used as the patch, the filler, and the covering material of the present invention is intended to solve such problems. Further, a conventional artificial artificial cartilage such as a fully-substituted type of artificial artificial intervertebral plate which is clinically tried is attached to both sides (upper and lower sides) of a core composed of a living inactive polyethylene or a rubber having a living body suitability, and has a superimposed The end plate of two pieces of metal made of titanium or cobalt-chromium, that is, the artificial intervertebral plate of the so-called sandwich structure, the core part is made to approximate the action of the living intervertebral plate in the state of overlapping of two pieces of polyethylene, and in the case of rubber, Its elasticity can be imitated. Further, it is prevented from falling off when inserted into the intervertebral space, and a plurality of angles are formed on the surface of the metal plate in order to impart an autonomic effect, and this structure is fixed so as to be spurted on the concave surface of the vertebral body. However, since the artificial intervertebral plate is a sandwich structure of a dissimilar material between the intervertebral plate and the living body, friction occurs at the interface between the repetitive motions, and the motion cannot be said to be the same as that of the living intervertebral plate, and protrudes from the metal plate. The angle, which will hurt the upper and lower vertebral bodies, 14 326\total file\91 \91134292\91134292 (replacement)-2 1252112 will slowly sink into the vertebral body under long-term use, resulting in greater invasion. Major defects such as harm, can not be directly combined with the upper and lower vertebral bodies and stand and stand. The implant material for artificial cartilage of the present invention is mainly intended to solve such problems. The purpose is to separate the artificial intervertebral plates by separating the porous body of the present invention from the end plate or the vertebral body. The physical gap is buried to make it "close" and can be directly bonded to the vertebral body via bone conduction. SUMMARY OF THE INVENTION The most basic implant material of the present invention is a bioactive biodegradable biodegradable bioactive ceramic powder granule uniformly dispersed in a biodegradable/absorbable polymer in vivo. The absorbed porous body is an organic-inorganic composite porous body having continuous pores and having a part of bioceramic powdery particles exposed on the inner surface of the pore or the inner surface of the pore and the surface of the porous body. As described later, the porous system has a porosity of 5 〇 to 90%, and the continuous pores account for 50 to 90% of the entire pores, and the continuous pores are required to be suitable for proliferation and stabilization of bone bud cells. 〇〇~4 〇〇# m aperture. Further, it contains a large amount of bioceramic powder particles up to 60 to 90% by weight, the porous body has a thickness as large as 1 to 50 mm, and has a three-dimensional shape. This basic implant material can be used in a variety of medical applications such as implant-based structures for the replacement of bone tissue, patchwork, covering materials, bone materials, sponge bone substitutes, bone tissue and other artificial implant materials. The medium, the carrier of the drug, and the like. Further, the biologically active biodegradable/absorbable porous body of the biologically active bioceramic powdery particles is uniformly dispersed in the biodegradable/absorbable polymer in the living body, and the system is configured to have continuous pores. And the content of the bioceramic powdery particles is 60 to 90% by weight of the organic-inorganic composite poly 15 326\total file\91\91134292\91134292 (replacement)-2 1252112 implant material formed by the pore body, The basic implant material of the present invention can be used in various medical applications as described above. The above-mentioned implant material composed of the organic-inorganic composite porous body can be produced by the production method of the present invention, that is, in a volatile solvent, the biodegradable/absorbable polymer in vivo is dissolved to make a living organism The active bioceramic powdery particles are dispersed to prepare a mixed liquid, and the mixed liquid is used as a nonwoven fabric-like fiber assembly, which is press-formed under heating to form a porous fiber assembly, and then the fiber assembly is formed. A method of immersing in a volatile solvent to remove the solvent. On the other hand, the implant material of the present invention using the above-described organic-inorganic composite porous body is a combination of the above-mentioned organic-inorganic composite porous body and other densely-formed biodegradable/absorbable members in vivo. The implant material mainly has the following four types: The first implant material is a shaft nail of other biodegradable/absorbable members in vivo. The shaft nail penetrates and integrates the above porous body into a single body. Both end portions protrude outward from the porous body to serve as an implant material for bone fixation. This implant material is suitable for use in, for example, a sternal median incision and occlusion surgery, and is suitable for use in the case of a fixed incision and sternum. The first implant material, which is a biodegradable/absorbable member in the living body, is a biodegradable/absorbable polymer in vivo containing a bioactive ceramic powder particle with voids leading to the outside. The base (matr 1X) is formed by interposing the porous body in the cavity of the matrix and integrally joining the implant material from which the porous body is exposed. The implant material is used in the anterior or posterior interbody fixation, and is suitable for use as a vertebral fixation material such as a vertebral 16 326\ total file \91 \91134292\91134292 (replacement)-2 1252112 interbody spacer. A third implant material, which is a biodegradable/absorbable member in vivo, is a skin layer composed of a biodegradable/absorbable polymer containing biologically active bioceramic powder particles. The epidermis is laminated to a part of the surface of the block-like porous body to be integrated into an implant material. The porous material of the implant material can exert the function of the sponge bone, and the epidermis layer can exert the function of the cortical bone, and is suitable for the full absorption and replacement artificial bone used for the replacement of the same kind of bone piece or the self-transplanting bone piece. Case. The fourth implant material, which is a biodegradable/absorbable member in vivo, is a network composed of a biodegradable/absorbable polymer containing biologically active bioceramic powder particles. The mesh material of the mesh body is filled with the porous body and integrated into the implant material. This implant material is suitable for use as a patch, a covering, a support, or a sputum filling of a bone defect or a deformed portion. Further, another implant material of the present invention which uses the above porous body is a multi-axial three-dimensional weave structure or a braided structure in which the organic fibers are three or more axes, or a composite structure of the composite structure. An implant material for artificial cartilage formed by integrating the at least one surface of the core material composed of the body. The implant material is suitable for use as an artificial intervertebral plate or a meniscus which is _1L from the upper and lower vertebral body sigma. [Embodiment] Hereinafter, preferred embodiments of the implant material and the production method of the present invention will be described in detail. The most basic implant material of the present invention is biodegradable / 326 \ total file \91\91134292\91134292 (replacement)-2 yield 1252112 absorbed polymer, substantially uniformly dispersed biologically active The biologically active biodegradable/absorbable porous body of the bioceramic powdery granule is configured to have continuous pores, and a part of the bioceramic powder is exposed on the inner surface of the pore or the inner surface of the pore and the surface of the porous body. In the preferred embodiment, the organic/inorganic composite porous body of the particles is used as a biodegradable/absorbable polymer in vivo, and it has been put into practical use and has been confirmed to be safe, and the decomposition is relatively fast, even if it is a porous body. Not brittle polymer. That is, a fully bioabsorbable poly-D, L-lactic acid, a block copolymer of L-lactic acid and D, L-lactic acid, a lactic acid and a thioglycolic acid, which can be used in combination with amorphous or crystalline and amorphous. Copolymer, a copolymer of lactic acid and p-dialkyl ketone (p-di ο X a η ο ne), a copolymer of lactic acid and ethylene glycol, a copolymer of lactic acid and caprolactone, or a mixture thereof A biodegradable/absorbable polymer in vivo. In the production method of the present invention, it is preferable to use a fiber aggregate having a non-woven fabric shape or a period of decomposition and absorption of the porous body in the living body, and the viscosity average molecular weight is preferably 50,000 to 1,000,000. In particular, when the nonwoven fabric-like fiber assembly is formed by the production method of the present invention, and the solvent composition obtained by press-forming the fiber assembly under heating is treated with a volatile solvent, the monomer ratio is caused. And showing amorphous poly-D, L-lactic acid, a block copolymer of L-lactic acid and D, L-lactic acid, a copolymer of lactic acid and glycolic acid, a copolymer of lactic acid and p-dione, and the like. The biodegradable/absorbable polymer in the body is preferred. If such a polymer is used, it can be obtained even if it contains a large amount of bioceramic powdery particles, it is not brittle, has a compressive strength comparable to that of a sponge, and is porous with ceramic monomers. The body is different, it can be thermally deformed at a relatively low temperature (about 70 °C), and can be rapidly hydrolyzed in the living body 326\total file\91\91 】34292\91134292 (replacement)-2 18 1252112 An implant material composed of an organic-inorganic composite porous body that is completely absorbed within 6 to 1 months. The implant material having such characteristics is excellent as a material to be filled by the defective portion of the living bone. Since it is a composite, it is different from the ceramic-only material, and the viscoelasticity due to the resin component remains. It is not damaged by brittleness when it is contacted by ceramics, and it can be formed by heat deformation during the operation to match the defect portion, and has the advantages unique to the thermoplastic polymer. The molecular weight of the biodegradable/absorbable polymer in vivo is due to the influence of the time from self-hydrolysis to full absorption and the ability to fibrillate. Therefore, it is preferred to use the above-mentioned polymer having a viscosity average molecular weight of 50,000 to 1,000,000. . a polymer having a viscosity average molecular weight of less than 50,000, which is hydrolyzed into an oligomer or a low molecular weight of a monomer unit, although short in time, but due to insufficient thready, the manufacturing method according to the present invention is It is difficult to form a fiber assembly system under one side by fiberization by means of spraying or the like. Further, a polymer having a viscosity average molecular weight of more than 1 million is not suitable for the purpose of replacing the living tissue as soon as possible, since it takes a long time to completely hydrolyze. Although it is different depending on the polymer, a preferred viscosity average molecular weight is preferably about 100,000 to 300,000. If a biodegradable/absorbable polymer having a molecular weight in this range is used, the formation of the fiber assembly is easy. An implant material having a composite porous body having an appropriate hydrolysis end time can be obtained. Further, in the implant material composed of the organic-inorganic composite porous body, as the bioceramic powdery particles dispersed in the porous body, bioactive and good bone conduction energy (sometimes expressed by osteoinductive energy) can be used. With good living body 19 326\ total file \91\91134292\91134292 (replacement)-2 1252112 Affinity. As such bioceramic powdery particles, there may be mentioned: a bioactive sintered surface, a test-sintered hydroxyapatite, an apatite apatite glass ceramic, a biologically active and fully bioabsorbable in vivo. Test-burned, unsintered apatite (hydr ο X yapatite), diammonium phosphate, triphosphonium phosphate, tetracalcium phosphate, octacalcium phosphate, calcite, cera vital, diopside (di Op side), powdery particles such as natural corals. Further, a basic inorganic compound or an alkaline organic substance may be attached to the surface of the powdery particles. Based on the ideal reason for tissue regeneration by full replacement of the bone tissue itself, among these, the bioceramic powder particles which are fully bioabsorbable in the living body which can be completely absorbed in the living body and completely replaced with the bone tissue are Jia' Ewing has high activity, excellent bone conduction energy, excellent bio-affinity and low hazard, and can be absorbed by living organisms in a short period of time, while untested, unsintered hydroxyapatite, tricalcium phosphate, and phosphoric acid Calcium is the most suitable. The above-mentioned bioceramic powdery particles are used in an average particle diameter (average particle diameter of primary particles) of 0. It is preferable that 2 to 10 // m is used, and if a bioceramic powdery particle having a larger particle diameter is used, in the production method of the present invention, when the mixed solution of the powdery particles is sprayed for fibrillation The fiber is cut off due to its shortness, and it is difficult to form a fiber aggregate. Even if a fiber aggregate can be formed, the bioceramic powder particles may settle somewhat before the fiber is solidified, resulting in dispersion unevenness. If the size is more than 20 to 3 0 // m, even if it is completely bioabsorbable, it takes a long time to completely absorb, and sometimes a tissue reaction occurs, which is not preferable. The preferred particle size of the bioceramic powder particles is 0. 2~5 // m, if such bioceramic powder particles are used, even in the manufacturing method of the present invention, the 20 326\total file\91\91134292\91134292 (replace)-2 1252112 powder particles are When the mixture is mixed at a high concentration and fibrillated to form a fiber assembly so as to have a fiber diameter of about 1 to 3 // m, the fiber is difficult to be cut, and the powder is high in the concentration of the present invention. The granules are surrounded by fibers in a state where the fibers are exposed, and the fiber assembly is immersed in a volatile solvent to form a composite porous body in which the pulverulent particles are exposed from the inner surface of the surface or continuous pores. The content of the bioceramic powdery granules is for the purpose of medical use such as a plant-based structure of regenerative medical engineering or a carrier for DDS or a replacement for a heterogeneous sponge bone (a homologous bone graft). In the case of an implant material composed of an organic-inorganic composite porous body, the bioactive effect of the bioceramic is considered, and it is preferably 60 to 90% by weight. A fiber assembly comprising a bioceramic powdery particle as in the production method of the present invention, which is formed by press-forming a fiber assembly formed by heating, and immersed in a volatile solvent to obtain a composite porous body. Since it can contain a large amount of bioceramic powdery particles in the range of fibrillation, as described above, the content of the bioceramic powdery particles can be as high as 60 to 90% by weight (corresponding to an average particle diameter of 3) // The volume % when m is a powdery particle having a specific gravity of 2 · 7 is a high ratio of about 4 1 to 8 1 %). When the content of the bioceramic powdery granules exceeds 90% by weight, the fiber is cut into a short fiber at the time of fiber formation, and a satisfactory fiber cannot be obtained, so that formation of the fiber aggregate is difficult, and on the other hand, if it is low When the amount is 60% by weight, the bioceramic powdery particles are insufficient, and the surface is exposed to the surface. Therefore, since the implant material is buried in the living body, the biological activity from the bioceramic powdery particles cannot be exhibited. Thus, the bioactive ceramic powder particles can be uniformly dispersed in a 60-90 weight 21 326\ total file \91 \91134292\91134292 (replacement)-2 1252112% of the high content rate of the composite porous body, Unprecedented, it is one of the basic implant materials of the present invention. The preferred volume % of the bioceramic powdery particles is from 50 to 85 vol%. The volume % is a volume percentage of the bioceramic powdery particles relative to the volume of the polymer when the porosity of the polymer in the composite porous body is 〇%, and the weight of the bioceramic powdery particles contained is even the same, based on The specific gravity or average particle diameter of the bioceramic powdery particles, which will vary accordingly. Therefore, in consideration of the specific gravity or the average particle diameter of the bioceramic powdery particles, it is preferred to contain 50 to 85 % by volume. A more preferable volume% is 50 to 80% by volume. A porous ceramic obtained by sintering a ceramic such as hydroxyapatite is hard and brittle, and the thin material is liable to be cracked or damaged when subjected to an external force, and thus cannot be satisfied as an implant material. In contrast, the composite ceramic porous body in which the bioceramic powdery particles are contained in the amorphous biodegradable/absorbable polymer is in the case where the content of the bioceramic powdery particles is as high as 60 to 90% by weight. Due to the bonding effect of the polymer, the compressive strength of the comparable sponge bone which maintains flexibility and is not brittle, specifically, the compressive strength of the extent of IMP a 5 MPa, as described above, can be applied to the sponge Substitute for bone and other medical uses. Further, the above-mentioned compressive strength is an automatic drawing machine (Autograph) AGS-2000D manufactured by Shimadzu Corporation, according to the test method of FISK7181 (however, the size of the sample is made to be 10 X 1 0 X 1 5 mm, The compression rate was fixed at 5 mm/min. The implant material composed of the organic-inorganic composite porous body has a porosity (total porosity) of 50% or more, and technically, about 90%, but the physical strength and bone of the composite porous body Invasion and stabilization of bud cells 22 326 \ total file \91\91134292\91134292 (replacement) - 2 1252112 Considered, about 60~80%, and consider the invasion of bone bud cells into the center of composite porous body For the efficiency of the part, the continuous pores are preferably 5 〇 to 90% of the total pores, and more preferably 70 to 9.0%. The continuous pores of the organic-inorganic composite porous body have a pore size of about 100 to 400 // m. After several times, the pore size of the porous ceramic and the invasion and ampoules of the bone bud cells were studied. As a result, it was found that the pore size of 3 〇〇 to 400 +/- m was most effective in calcification, and the deviation was The effect is smaller. Therefore, although the pore diameter of the composite porous body is about 1 〇〇 to 4 〇〇 # m as described above, it includes a pore diameter in the range of 50 to 500 / / m, and the distribution center is 2 〇〇 4 〇〇 / / m can. In the case where the pore diameter of the continuous pores is larger than 4 〇 ❿ a❿ and the porosity (total porosity) is higher than 90%, the strength of the composite porous body is lowered, so that the damage in the buried body in the living body is extremely large. On the other hand, if the pore diameter is smaller than 1 〇 〇 #m and the porosity is lower than 50%, the strength of the composite porous body can be increased, but the bone bud cells are hard to intrude, and the time from hydrolysis to complete absorption becomes long. However, such a composite porous body having a small pore size is likely to be used as a carrier of DDS in order to maintain a long-term slow release property in parallel with the decomposition of the polymer. The preferred pore diameter of the continuous pores is 150 to 350 / / m, and the preferred porosity (total porosity) is 7 〇 to 80%. Further, the pore diameter of the continuous pores or the ratio of the continuous pores to the entire pores is in the production method of the present invention. 'By adjusting the compression ratio when the fiber assembly is press-formed into a fiber assembly, or the fiber assembly is formed. The external pressure to maintain the shape when the shape is immersed in a volatile solvent is controlled. The above-mentioned implant material composed of the organic-inorganic composite porous body can be used for, for example, a defect portion buried in a living bone at 23 326V total file \91\91134292\91134292 (replacement) 2 1252112, at which time the living body θ is utilized. 4 The thermoplasticity of the polymer degraded/absorbed is deformed by heating the implant material to 7 ° C to match the shape of the defect, and @ g _ is buried in the defect portion, so it is buried Homework can be as simple as IE: 3⁄4丨 also _ line. Moreover, since the biodegradable/absorbable polymer in the living body has a hardness of $blade and ceramic, it can be used in the shape of a scalpel stomach @ $ arbitrary shape without damaging the shape during surgery. When the implant material composed of the composite porous body is buried in the defect portion of the living bone in the above manner, the liquid rapidly permeates into the composite porous body from the surface of the composite porous body through the continuous pores, so the self-composite porous body Both the surface of the body and the inside of the continuous pores, the hydrolysis of the biodegradable/absorbable polymer in the living body proceeds almost simultaneously, and the porous body is uniformly decomposed as a whole. Then, through the bone conduction energy of the bioceramic powdery particles exposed on the surface of the composite porous body, the bone tissue can be rapidly formed and formed in the surface layer portion of the composite porous body, and grows into a small column of bone, in a short period of time, compounding The porous body can be combined with the defect site of the living bone, and the bone conduction energy of the bioceramic powdery particles exposed on the inner surface of the pore can also invade the inside of the composite porous body, and the bone bud cells will conduct and grow, so Directly binds to the surrounding bone. This phenomenon becomes remarkable as the decomposition of the biodegradable/absorbable polymer in the living body progresses, and is slowly replaced with the surrounding bone. Finally, the polymer is completely decomposed and absorbed, and the bioabsorbable bioceramic powdery particles are completely absorbed, and are completely replaced by the grown bone tissue to complete the regeneration of the bone defect site. The wet material of the implant material composed of the composite porous body is in the form of a wet ceramic material, which is exposed to the surface due to a large amount of moisture. The wettability of the particles is significantly improved compared to the porous body of the biodegradable/absorbable polymer in vivo. If the composite porous body is subjected to oxidation treatment such as corona discharge, plasma treatment or hydrogen peroxide treatment, The wetting property of the polymer can also be improved, and the invasion and growth of the bone bud cells to be proliferated can be carried out more efficiently. Further, when various bone forming factors, growth factors, pharmaceutical agents, and the like are preliminarily filled into the pores of the composite porous body, or are previously dissolved in the biodegradable/absorbable polymer in the living body to be carried, the composite is corresponding to The rate at which the porous body is decomposed and absorbed is gradually released, so that bone regeneration and disease healing can be effectively promoted. Examples of the main bone formation factor include BMP. As a main growth factor, monocaine or lymphoids such as IL-1, TNF-α, TNF-/S, and IFN-r may be mentioned. A medium (lymphokine), or a colony stimulating factor, or a so-called growth differentiation factor of TGF-α, TGF-0, IGF-1, PDGF, FGF, and the like. Further, as the drug, a drug capable of bone growth (vitamin D, a prostaglandin, or an anticancer drug), an antibacterial agent, or the like can be arbitrarily selected. Next, the method for producing an implant material composed of the organic-inorganic composite porous body of the present invention will be specifically described in detail. The manufacturing method of the present invention is as follows. First, the biodegradable/absorbable nozzle substance i is dissolved in a volatile solvent, and the bioactive ceramic powder particles are dispersed to prepare a mixed liquid. As the volatile solvent, a solvent such as low-boiling methane chloride (cHchloromethane), dichloroethane, methylene chloride or chloroform which is easily volatilized at a temperature lower than normal temperature can be used. Further, it is also possible to use a non-solvent having a boiling point higher than the boiling point of the solvent 25 3 26 \ total file \91 \91134292\91134292 (replace)-2 1252112, for example, a boiling point of 60 to 110 ° C, alcohol, ethanol And one of alcohols such as 1-propanol, 2-propanol, 2-butanol, tert-butanol, and diol, or a mixture of two or more thereof. Next, a fiber aggregate of a non-woven fabric was formed from the above mixed liquid. In the section, the dissolving mixture is sprayed into a sprayer by means of spraying the dissolved mixed solution, that is, the above-mentioned dissolved mixed liquid is sprayed into the sprayer, and the mixed liquid is sprayed from the spray hole of the sprayer to the body by a high-pressure jet of nitrogen or the like. Then, the fiber is gradually fibrillated under the volatilization of the volatile solvent, and the fibers of the biodegradable/absorbable polymer containing the biological powdery particles are connected to each other under the fusion of the mutual joints, and are solidified and stacked to form an arbitrary shape. A non-woven fabric aggregate of thickness. The shape of the interfiber voids of the fibrillation system is different from that of the cell-like pores, and the fused fibers form a continuous space of several hundred μm with each other, and the bioceramic particles are surrounded by the fibers (some of which are partially exposed to the surface). ) is uniformly dispersed throughout the entire body of the fiber. The resin containing 60% by weight or more (sometimes 50% by volume or more) of the bioceramic powdery particles is solidified and fixed in a state of being dispersed without being separated by precipitation, and is internally formed. The material includes a continuous space for the pores, so that the solvent is volatilized by forming a fine fiber on one side as in the production method, and the method is solidified in a short time before the separation of the bioceramic particles. The 'is also the novelty of the manufacturing method of the invention. Also, it is necessary to produce 5~ 326\total file for the medical use of implant materials. \91 \91134292\91134292 (replacement of the combination of the three glutinous rice and its hand. Non-live spray ceramic interaction, can be cured The porcelain powder is collected in a large amount of the composite porous body of the sprayed porcelain powder, which is 50 mm 26 1252112. After the fiber assembly is formed by spraying, the solvent is volatilized to be dried, and then sprayed thereon. A predetermined thickness is formed by a thickening operation. As the object to be sprayed, a mesh or a plate body made of polyethylene having good peelability, another hydrogen storage resin, a fluororesin, a sand resin, or the like can be used. In particular, if a mesh-like freely ventilable object is used, the mixture is fibrillated by spraying, and after hitting the mesh, the volatile solvent volatilizes through the mesh, so the mesh The fibers on the body side surface are fused without forming a skin layer (only the fusion layer of the resin), and there is an advantage that the fiber assembly which can be subjected to the solvent impregnation treatment in the subsequent steps can be easily formed. It is preferable to use a mesh of 50 to 300 mesh, and a mesh body having more than 50 mesh. Since the fiber is wrapped into the back side through the mesh, it is difficult to peel the formed fiber aggregate from the mesh body. The mesh body having a smaller mesh size than 300 mesh is difficult to form a skin layer by merging the fibers on the side of the mesh body due to the difficulty in volatilization of the volatile solvent. Further, the object to be sprayed is not limited to a flat mesh body or a plate. As the shape, a three-dimensional mesh or plate-like body of convex curvature and/or concave curvature can be used. If such a three-dimensional object to be sprayed is used, there is an advantage that a thick fiber aggregate can be formed in a three-dimensional shape. As described above, the fiber assembly formed by spraying and mixing the mixed liquid has a void between fibers of several hundreds μm, and a ratio (void ratio) of the fiber voids is about 60 to 90%. The inorganic powdery particles are uniformly dispersed in the whole of the fiber assembly without sedimentation. The fiber length of the fiber assembly is preferably about 3 to 100 mm, and the fiber diameter is 0. 5~50 // m is better. With such a degree of fiber length and fiber 27 326 \ total file \91 \91134292\91134292 (replacement) - 2 1252112 diameter fiber aggregate 'through the solvent soaking treatment of the subsequent steps, the fiber can be easily blended' It is preferred to form a composite porous body in which the fibers have substantially disappeared. The fiber length 'mainly depends on the molecular weight of the biodegradable/absorbable polymer in the living body, the polymer concentration of the mixed liquid, the content or particle size of the bioceramic powdery particles, etc. The higher the molecular weight, the higher the concentration of the polymer. The smaller the content of the bioceramic powdery particles and the smaller the particle size of the bioceramic powdery particles, the longer the fibers tend to be. On the other hand, the fiber diameter mainly depends on the polymer concentration of the mixed solution, the content of the bioceramic powdery particles, the size of the spray hole of the sprayer, etc., the higher the concentration of the polymer, the higher the content of the bioceramic powdery particles. The larger the injection hole is, the more the fiber diameter tends to be thicker. Further, the fiber diameter also changes due to the pressure of the injected gas. Therefore, in order to obtain the above fiber length and fiber diameter, it is necessary to adjust the molecular weight of the polymer, the concentration of the polymer, the content and particle diameter of the bioceramic powdery particles, the size of the injection holes, the gas pressure, and the like. Then, the process proceeds to a step of pressurizing the fiber assembly by heating to form a porous fiber assembly. First, the fiber assembly is solidified under heat/pressure to form a preform having continuous voids, and the preform is subjected to pressure forming at a pressure higher than the pressure at that time to form a continuous void ratio. A porous fibrous aggregate formed body having a strength adjusted with a hole size. Further, the heating at the time of press molding is such that the fiber assembly is slightly softened, and the degree of pressurization is such that the porosity of the finally obtained composite porous body is 50 to 90%, and the pore diameter of the continuous pores is about 10 0~400 β m can be adjusted. 28 326\总档\91 \91134292\91134292 (replacement)-2 1252112 Then, in the next step, the fiber assembly formed in the previous step is immersed in the above volatile solvent to sufficiently permeate the solvent to Inside the molded body. Then the solvent was removed. When the fiber assembly molded body is immersed in a volatile solvent, the fiber assembly molded body is filled in a mold having a surface having a large number of pores, and a moderate pressure is applied to the fiber assembly molded body from the outside. The impregnation is carried out while maintaining its shape. Alternatively, the upper surface of the fiber assembly may be passed through a solvent to permeate it. Further, in order to maintain a predetermined shape, it is preferred to remove the solvent inside the fiber assembly by vacuum suction as early as possible. When the fiber assembly molded body is immersed in a volatile solvent and the solvent is impregnated into the molded body as described above, the fibers are dissolved in the solvent from the surface, and the fibers are condensed while being shrunk, and the fibers are substantially eliminated to form bubbles. membrane. Then, in a state in which a circular continuous pore having a pore diameter of about 100 to 400 // m is formed, a bubble wall is formed to change the morphology of the continuous pore. Then, a part of the bioceramic powdery particles contained in the fiber is embedded in the pore film (in the bubble wall) without sedimentation as the fiber is fused and the morphology of the film is changed. A part of the film is exposed from the pore film, and the powdery particles are infiltrated and exposed to the extent that they are not easily peeled off on the surface of the porous body. However, depending on the conditions, the skin layer is formed on the surface and the bioceramic powder particles are not exposed on the surface of the porous body. In this case, the skin layer may be removed by sanding to expose the inorganic powder particles present on the surface layer. practice. Thus, it can be obtained by having continuous pores, and while a large amount of bioceramic powdery particles are uniformly dispersed, the inner surface of the pores and the surface of the porous body are exposed with 29 3 26\total file\91\91134292\91134292 (replacement)- 2 1252112 A part of an implant material composed of an organic-inorganic composite porous body of bioceramic powder particles. When the composite porous system is immersed in a volatile solvent, the pore diameter of the continuous pores can be controlled to be suitable for invasion and stabilization of bone bud cells by applying an external pressure to maintain the shape thereof. The preferred one is about 1 to 400 //m, and the porosity is controlled to the extent of 50 to 90%. Further, the immersion treatment of the volatile solvent in the fiber assembly molded body is carried out under heating at 50 to 60 ° C, and it is only necessary to place the fiber assembly molded body for a short period of time, and the fibers can be sufficiently fused to each other efficiently. Composite porous body. In the manufacturing method of the present invention, in the range of fibrillation, it may be 60 to 90% by weight (corresponding to an average particle diameter of 3 // m, a specific gravity of 2. 7 to 81% by volume of the unsintered hydroxyapatite bioceramic powdery particles are uniformly contained in the composite porous body, even if contained in a large amount, since the bioceramic powdery particles are separated before sedimentation, Since the solvent volatilizes to fuse the fibers, the porous body obtained by the above-described solution precipitation method can produce a composite porous body which is more uniformly dispersed in the bioceramic powdery particles and which has not been obtained so far. However, if the content is too high, the amount of the biodegradable/absorbable polymer in the living body as a binder becomes small, and the composite porous body becomes brittle, and it is difficult to maintain the shape, so there is an upper limit. (Examples) Next, the implant material composed of the organic-inorganic composite porous body of the present invention will be further described by way of specific examples. (Example 1) Poly-D,L-lactic acid (PDLLA) having a viscosity average molecular weight of 200,000 (D-milk 30 326\total file\91\91134292\91134292 (replacement)-2 1252112 acid and L-lactic acid The molar ratio is 5 0/5 0) The polymer solution (concentration: PDLLA 4g / dichloromethane 100ml) dissolved in methylene chloride, and the unsintered hydroxyapatite with an average particle size of 3 // m A mixture of powdery particles (U_HA powdery particles) mixed in ethanol is uniformly homogenized, thereby preparing a ratio of the amount of the u-HA powdery particles to 200 parts by weight relative to 100 parts by weight of the PDLLA. The mixture is mixed. The sprayer was charged with the above suspension using an HP-E airbrush (manufactured by Anista Iwata Co., Ltd.) at a pressure of 1. Nitrogen gas of 6 kg/cm2 was sprayed onto a polyethylene mesh body (150 mesh) at a distance of about 120 cm to form a fiber aggregate, and the fiber assembly was peeled off from the mesh body. The fiber diameter of the fiber assembly is 1. Around 0//m, the fiber length is about 10~20mm, and the apparent specific gravity is 0. 2 〇 The fiber assembly was cut into an appropriate size and filled into a cylindrical master mold having a diameter of 30 mm and a depth of 30 mm, and the specific gravity of the fiber assembly was made 0. The mode of 5 was compressed by a male mold to obtain a disk-shaped fiber assembly molded body having a diameter of 30 mm and a thickness of 5 mm. Then, the fiber assembly was immersed in a solvent made of methylene chloride mixed with ethanol, and the solvent was allowed to permeate into the inside of the molded body, and after standing at 6 CTC for 10 minutes, the solvent inside the molded body was sucked by vacuum. The organic-inorganic composite porous body having a diameter of 30 mm, a thickness of 5 mm, and a content of u-HA powdery particles of 70% by weight was obtained. A partial cross section of the composite porous body was observed by an electron microscope, and it was found that the fibers disappeared by fusion to form a continuous pore having a large pore diameter of about 100 to 400 // m, and the u-HA powdery particles were uniformly dispersed in the pores. Face and Porous 31 3 26\Total File\91 \91134292\91134292 (Replace)-2 1252112 A part of the body surface with u-HA powder particles is exposed. The apparent specific gravity of the composite porous body is 0. 5, the ratio of continuous pores to the total pore volume (continuous porosity) is 75%, and the compressive strength is l. lMPa. (Example 2) A disk-shaped fiber assembly molded body having a diameter of 30 mm and a thickness of 5 mm was prepared as a preform in the same manner as in Example 1 and heated in a gear oven to 80 ° C. Into the chamber with the diameter-reducing diameter reduction portion, press it into the lower part of the diameter of 10. In a 6mm cylinder. According to this, the compression strength of the cylindrical rod-shaped fiber assembly formed by pressurization under heating is about 2. 5 Μ P a. Then, the cylindrical rod-shaped fiber assembly molded body is filled in a cylinder of the same diameter around which the opening is opened, and pressure is applied from the upper and lower sides thereof to the extent that the height of the cylindrical rod-shaped fiber assembly is not changed. At the same time as pressing, it was immersed in a solvent (60 ° C) formed of a mixture of 15% by weight of methanol in methanol (10 ° C) for 10 minutes, and then the solvent was removed to obtain a composite porous body. A partial cross section of the composite porous body and a frosted surface were observed by an electron microscope to obtain a porous form in which the fibers disappeared, and a pore having a pore diameter of about 150 to 300 μm was formed, u - Η A powdery particles are exposed from the surface of the porous body or the inner surface of the pores. The apparent specific gravity of the composite porous body is about 〇. 5 5, the continuous porosity is 70%, and the compressive strength rises to about 3. 5MPa. The composite porous body is estimated from the in-vivo decomposition and absorption characteristics of the bulk average molecular weight of PDDLA and the proportion of the u-HA powdery particles having an average particle diameter of 3 μm, depending on the buried portion or Depending on the size, push j can be fully absorbed from 6 months to 12 months. 32 326\总档\91\91134292\91134292 (replacement)-2 1252112 (Example 3) PDLLA with a viscosity average molecular weight of 1 million (the molar ratio of D-lactic acid to L-lactic acid is 3 0/70) In the same manner as in Example 1, a mixed liquid obtained by uniformly mixing 80% by weight of /3 -tricalcium phosphate powder particles (々_τ c P powder particles) having an average particle diameter of about 3 // m was prepared. This /9 - T C P powdery granule was confirmed to have biological activity and in vivo absorption, and its mechanism was different from that of u _ Η A powdery granules, but it was found to have osteoconductivity of HA production in vivo. Using the mixture, the fiber assembly produced by the spray method similar to that of Example 2 was compression-molded into a fiber assembly molded body by heating, and subjected to solvent immersion treatment to obtain an apparent specific gravity of about 0.6, and a continuous porosity. It is 7 5 % and the compression strength is 4. 2 MPa composite porous body. The volume ratio of the /5-TCP powdery particles of the composite porous body is about 65 % by volume, and the volume ratio of the 10,000-TCP powdery particles is far more than 70% by weight (about 55 % by volume) of the u-HA powdery particles. Since the composite porous bodies of Examples 1 and 2 are large, the biological activity can be remarkably exhibited by the exposure of the /3-TCP powdery particles on the surface of the porous body or the inner surface of the pores. In the composite porous body, the fibers in the non-woven fabric aggregate disappear and change to the form in which the /3 -TCP powder particles are buried in the bulk cell wall, so even when immersed in the body fluid in the living body It is also not easy to disintegrate and the powdery particles are dispersed to the surroundings, and it is confirmed that it exhibits good biological activity at a level of 5 to 8 months and can be completely decomposed and absorbed. Therefore, the composite porous body can be a plant-based structure for a good hard tissue (hard bone, cartilage). (Example 4) D, L-lactic acid (Mole ratio 1 of D/L) and glycolic acid (GA) were blended in such a manner that the molar ratio was 8:2, and the viscosity average molecule was synthesized by a known method. 326\Total file\91\91134292\91134292 (replacement)-2 1252112 The amount of copolymer P (DLLA-GA) is 130,000. In the same manner as in Example}, a mixture of 60% by weight of octacalcium phosphate powder particles (OCP powder particles) uniformly mixed with the polymer was prepared, and a fiber assembly prepared by the same spray method as in Example 2 was prepared. Then, it is compression-molded into a fiber assembly molded body by heating, and subjected to solvent immersion treatment, and finally a composite porous body having a specific gravity of 〇·5 。 is obtained. The OCP powder particles of the composite porous system have high activity, and the decomposition and absorption of the copolymer are fast due to GA, so that good bone conduction (easily converted into new bone) is exhibited, and after 3 to 4 months, most of them are Absorbed and replaced by bone. (Example 5) D,L-lactide and p-dioxanone (pD〇X) were blended in such a manner that the molar ratio was 8:2, and copolymerization was carried out by a known method to obtain a viscosity average molecular weight of about 100,000 copolymer. The polymer of p - D Ο X is not soluble in a volatile general-purpose solvent, but is soluble in chloroform, dichloromethane or the like at the above ratio, so that the target can be obtained in the same manner as in the above-mentioned Example 1. Composite porous body. Further, the copolymer was more rubber-like than the copolymer P of P-lactic acid and glycolic acid of P of Example 4 (DLLA-GA), so the particle size of the bioceramic powdery particles was 3 When // m, the volume fraction of the powdery particles can be as high as 70% by volume (85% by weight), so the composite porous system can avoid the living reaction of the decomposition product of the copolymer as much as possible, and can be used very effectively. Activity of biologically active bioceramic powder particles. In particular, since the hydrophilicity of P-DOX is higher than that of PDLLA, the composite porous body can proliferate cells in vitro, and thus is effective as a planting structure for cartilage regeneration. 34 326\总档\91\91134292\91134292 (replacement)-2 1252112 As described above, the implant material composed of the organic-inorganic composite porous body of the present invention contains a polymer which is uniformly dispersed in vivo and biodegradable/absorbable. A large amount of bioceramic powdery particles of the material can be rapidly immersed by a continuous pore having a large pore diameter formed therein, and the bone conduction energy of the bioceramic powdery particles exposed on the surface of the porous body or the inner surface of the continuous pore can be quickly It is possible to carry out early regeneration with living bone or regeneration of living bone tissue, and has practical strength necessary for medical use, and can be easily and reliably produced by the production method of the present invention. Therefore, the implant material is as described above, and can be applied as a mediation structure for living bone tissue reconstruction, a patch material, a bone material, a mediation between other implant materials and living bone tissue, a substitute for a sponge bone, a drug. A carrier for slow release or the like. Next, a representative embodiment of the implant material of the present invention to which the above-described organic-inorganic composite porous body is applied will be described in detail with reference to the drawings. The implant material can be divided into a form in which the porous body and other dense in vivo biodegradable/absorbable members are integrated, and the porous body and the non-absorbable member in the living body are integrated. The form of the implant material of the former is exemplified by the various embodiments shown in Figs. 1 to 15 , and the latter is exemplified by the embodiment shown in Fig. 16 and Fig. 17. The implant material 1 shown in Fig. 1 is a sternal fixation implant material for the median incision and occlusion, which is a bone incision at a site where the bone beam becomes thicker and thinner due to a decrease in bone mass due to osteoporosis or atrophy of bone tissue. A representative example of a bioactive, biodegradable/absorbable bone fixation implant material that is occluded or surgically occluded by surgery. The implant material 1 has an organic-inorganic composite porous body 1 and a spindle 2 as a biodegradable/absorbable member in the body of 35 326\total file\91\91134292\91134292(replacement)-2 1252112, The spindle 2 penetrates the porous body 1, and both ends of the spindle protrude from the porous body 1. Further, in order to prevent rotation when embedded in the sternum, the shaft 2 is formed into a rectangular column shape, and the porous body 1 is formed in a rectangular parallelepiped shape. Further, both front ends of the nail 2 are formed into a pyramid shape which can be easily inserted into a hole formed in the bone marrow (sponge bone) of the sternum, and the surfaces of both end portions of the shaft 2 are formed to prevent the hole from being pulled out from the hole. The cross section of the spindle 2 is a zigzag unevenness 2a. Further, the porous body 1 may be formed in a cylindrical shape while the shaft 2 is formed in a cylindrical shape, or the unevenness 2a at both ends of the nail may be omitted. The porous body 1 is the same as the above-described organic-inorganic composite porous body, that is, in a biodegradable/absorbable polymer in vivo, substantially uniformly dispersing biologically active bioceramic powdery particles. The biodegradable/absorbable porous body in the body is a bioceramic powdery particle having continuous pores and having a portion on the inner surface of the pore and the surface of the porous body. The porosity of the porous body 1, the pore diameter of the continuous pores, the ratio of the continuous pores to the entire pores, the biodegradable/absorbable polymer in vivo, the bioceramic powdery particles, and the content of the powdery particles are as described above. . In the porous body 1 according to the above-described production method, the nonwoven fabric-like fiber assembly is press-molded into a rectangular parallelepiped shape by heating to form a porous fiber assembly, and immersed in a volatile solvent to obtain a rectangular parallelepiped shape. The organic-inorganic composite porous body is produced by piercing a hole for inserting the spindle 2 (a corner hole having a slightly smaller size than the spindle 2). The size of the porous body 1 can be selected depending on the case, and the size thereof is not particularly limited, but care must be taken not to make it too large (multiple). In the case of the sternal fixation 3 26 \ total file \91\91134292\91134292 (replacement) - 2 36 1252112, the length of the porous body 1 is set to 丨〇~丨5mm and the width is set to 6 It is preferably about 20 mm and a height of about 6 to 15 mm. The choice within this range depends on the patient's sternum structure, needless to say. If the respective sizes of the porous body 1 are lower than the lower limit of the above range, the amount of bone tissue which is formed to the porous body 1 by conduction is small. Further, the preferred size of the porous body 1 must also vary depending on the bone to be buried, needless to say. In the porous body 1, the functionality can be improved by containing the bone forming factor, the growth factor, the drug, and the like in an appropriate amount. When a bone forming factor or a growth factor is contained, bone formation inside the porous body 1 is remarkably promoted, and the porous body 1 can be replaced with the bone tissue earlier, and the semi-sternal bones of both sides of the incision and the lock can be directly bonded. Further, if the drug is impregnated into the drug, the drug can be directly absorbed by the half sternum of both sides, and the drug can be fully exerted. Further, the surface of the porous body 1 is subjected to the above oxidation treatment to improve the wettability, and the bone bud cells can be more effectively invaded and grown. On the other hand, the above-mentioned spindle 2 is composed of a biodegradable/absorbable polymer such as polylactic acid and polyglycolic acid which have been confirmed to be safe, in particular, having a viscosity average molecular weight of 150,000 or more. It is more preferable that the tube strength shaft nail 2 composed of a biodegradable/absorbable polymer in the living body is preferably (about 200,000 to 600,000). Further, a rod composed of a composite of bioactive bio-ceramic powder particles of about 10 to 60% by weight of the biodegradable/absorbable polymer in vivo or by compression molding A method of forging, stretching, or the like, such that the above polymer molecules or crystals are aligned to further increase the strength thereof, is also suitable for use. In particular, it is preferred to use a forged shape to make the polymer molecules or crystals into a three-dimensionally oriented compact 37 326\total file\91 \91134292\91134292 (replacement)-2 1252112. In the case of an implant material for sternal fixation, the length of the shaft nail 2 is preferably about 20 to 4 Omm. If it is less than 20 mm, the shaft nail for fixing the sternum is too short, and if it is longer than 40 mm, It can cause adverse conditions in the bone marrow (sponge bone) that are difficult to incorporate into the sternum. Further, the width of the spindle 2 is preferably about 2 to 4 mm, and the height is preferably about 2 to 3 mm. If the width of the spindle 2 is narrower than 2 mm and the height is smaller than 2 mm, it may become too thin and there is a concern that the spindle 2 is easily broken. On the other hand, if the width of the spindle 2 is wider than 4 mm and the height is larger than 3 mm. In the case, the combination with the porous body 1 will exceed the thickness of the sternum and is not feasible. Further, the above-described spindle size is a preferred size for the case of the sternal fixation implant material, and the preferred size of the spindle can be changed depending on the bone to be buried, needless to say. Next, an example of use of the above-described implant material 1 for sternal fixation will be described with reference to Fig. 2 . First, as shown in Fig. 2(a), the left and right half sternum b are cut in the middle, and the two steel wires 3, 3 are pierced through the cone, and the converging band 4 is passed through the half sternum B, B. Wrap between the ribs. In Fig. 2(a), only one of the converging belts 4' is wound, but a plurality of (usually four) windings are formed at intervals. Then 'put the half of the sternum b, B of the other sponge bones with tweezers (kocheO, etc. scrape out 'to form a plurality of holes 5 that can insert one-sided half of the implant material 1 〇 for sternum fixation (more implanted) Material 1 〇 a slightly smaller hole.) Next, as shown in Figure 2 (b), the one-sided half of the implant material 1 强力 is strongly squeezed into the single piece so that it does not pull out. The holes of the half sternum B are 326\total file\91\91134292\91134292 (replacement)-2 38 1252112 5. Then, as shown in Fig. 2(c), the steel wire 3, 3 is threaded, respectively The opposite side of the implant material 10 is squeezed into each of the holes 5 of the other half of the sternum B while 'the half sternum B of both sides is locked, and the ends of the steel wires 3, 3 are knotted several times to be solid. The ground is fastened, and the bundling belts 4 are knotted several times to firmly tie them. In this embodiment, although the steel wires 3 and the converging belts 4 are used to fix the semi-sternal bones B and B, they can also be used. The polylactic acid-like biodegradable/absorbable polymer in the living body or a strip formed by including the bioceramic powdery particles in the above-mentioned lactic acid. The material 1 is embedded in the bone marrow of the incision and the sternum, and at the initial stage of embedding, the 1 nail of the implant material is used as a "wedge" to spur the bones of both sides of the sternum B, B (sponge bone) ), the semi-sternal bones B and B of both sides are fixed to exert a reinforcing effect, so that the fixation stability of the semi-sternal bones of both sides can be improved. Thereafter, the bioceramic powder is exposed through the surface of the porous body 1 exposed to the implant material 1 The bone conduction energy of the granules can be formed on the surface of the porous body 1. Since the porous body 1 and the half sternum B of both sides are bound in the short time, the combination can increase the half of the two sides. Fixation stability and strength of the sternum B, B. The implant material 10, through the contact with the body fluid in the bone marrow, the shaft nail 2 and the porous body 1 will be hydrolyzed, because the porous body 1 will pass through the continuous pores, so that the body fluid Intrusion into the interior, so the hydrolysis is rapid, and the porous body 1 is transferred to the inside through the bone conduction energy of the bioceramic powdery particles exposed on the inner surface of the pore, and replaced with the bone tissue in a short period of time. And Especially in the case where the porous body 1 is impregnated with the above growth factor, the growth of the bone tissue is rapid, and the bone tissue can be replaced with the porous body 1 in a short period of time. Since 39 3 26\ total file \91 \91134292\91134292 (replacement) )-2 1252112 This 'locked sternum (semi-sternal B, B) can be directly combined by the bone tissue replaced with the porous body 1, so even the loose bone of the sternum is extremely hollow and porous It becomes brittle as a thin plate, and the fixation of the sternum can be stabilized by the new bone formed. On the other hand, the shaft nail 2 of the implant material 1 is slowly passed through contact with the body fluid. Hydrolysis 'When the porous body is replaced with the bone tissue, the hydrolysis has undergone a lot of 'shear into a thin piece, and finally all will be absorbed by the body and disappear. In this case, 'When the spindle 2 is composed of a composite of biodegradable/absorbable polymer and bioceramic powdery particulate matter as described above, and the shaft 2 is also osteoconductive, it is hydrolyzed. Repeatedly with the replacement of bone bud cells and osteoclasts of bioceramic powdery particles, it will conduct bone formation together with the phagocytic reaction of the decomposition piece, and the nail 2 will replace the bone tissue with the 'spin 2'. The hole will eventually be buried by the new bone and disappear. The implant material 1 for bone fixation composed of the organic-inorganic composite porous body 1 of the present invention and the spindle 2 is as described above, and can be used for embedding in the incision and occlusion in the operation of the sternal median incision and atresia. The sternum can also be used for osteoporosis caused by osteoporosis or atrophy of bone tissue, and the incision, the saw bone, or the fractured part of the bone is thickened and squashed, and the occlusion is performed by surgery. Finally, the bone tissue is replaced and the bone can be firmly fixed and fixed. The implant material shown in Fig. 3 is a vertebral body fixing material such as an interbody spacer as shown in Fig. 6. It is mainly used for insertion between a cervical C3-C4 or a lumbar vertebra L4-L5. The implant material is made from an organic-inorganic composite porous body 1 and an in vivo biodegradable/suction 40 326\total file of the open space 6a to the outside (replacement)-2 1252112 In the case of the substrate 6 of the received member, the porous body 1 is attached to the cavity 6a of the substrate 6 and is exposed from the inlet 6b of the cavity 6a, and the porous body 1 is stacked on the upper and lower sides of the substrate 6. It is set in a synthetic plate shape. The porous body 1 of the upper and lower sides of the substrate 6 is used as a substitute for the self bone, and as will be described later, the gap between the matrix 6 and the cervical vertebrae C3-C4 or the lumbar vertebrae L4-L5 is eliminated, and is early combined (fixed). Further, the porous body of the upper and lower sides of the substrate 6 may be omitted. The matrix 6 of the implant material is a dense, strong matrix composed of a biodegradable/absorbable polymer containing biologically active bioceramic powder particles, as shown in FIG. It is formed into a rectangular parallelepiped shape. In the substrate 6, two through-holes 6a extending in the longitudinal direction and two through-holes 6a in the lateral direction are formed so as to be entangled with each other, and the holes 6a are formed. The inlet 6b has two openings on the upper, lower, left and right sides of the substrate 6, respectively. Since the inlet 6b of the cavity 6a is an intrusion port of a liquid or the like, the porous body contained in the cavity 6a is partially exposed from each of the inlets 6b. Further, the hollow inlet 6b may be formed in front of or behind the substrate 6. In this case, it is preferable that the rear inlet is formed in a screw hole shape so that the front end of the inserted jig can be locked. This implant material 11 is cut into an inclined surface around the front surface 6 c of the substrate 6 in order to facilitate insertion into the cervical vertebra C3_C4 or the lumbar vertebra L4_L5. Then, in order to be inserted into the cervical vertebra C 3 - C 4 or the lumbar vertebrae L 4 - L 5 , the implant material 丨丨 without the positional deviation or detachment of the self-supporting type (do not support the fixing material), on the substrate 6 The upper and lower sides 6d, 6e are provided with a plurality of (6 in each figure) fixed protrusions 326 \ total file \91 \91134292\91134292 (replace) - 2 1252112 protrusions 6f, the front end of each protrusion 6f is from the substrate 6 The porous body 1 on the upper and lower sides protrudes. The protrusions 6f are formed on the upper and lower surfaces of the substrate 6 with a recess 6g' at the front end of the same biodegradable/absorbable polymer as the matrix 6, and a conical tip. The shaft nail 6h (6f) is implanted in the pocket 6g. Alternatively, a pointed tab may be implanted at the front end, or the protrusion 6f may be formed integrally with the substrate 6 instead of the spindle. As shown in Fig. 5, a communication hole 6j is formed in a wall portion between the two cavities 6a, 6a in the longitudinal direction of the substrate 6, and as described later, the porous body 1,1 attached to the cavity is formed as described later. The bone tissue formed by the transfer is connected and connected by the communication hole 6 j. This wall portion 6i serves to increase the compressive strength of the substrate 6. The size of the substrate 6 is about 18 to 30 mm in the previous and the size, and the size of the upper and lower heights and the left and right widths is about 6 to 24 mm. If various sizes in these ranges are used, the cervical vertebra C3-C4 or the lumbar vertebra L4 can be selected. -L5 size and intervertebral size are inserted. The substrate 6 of the implant material 11 has a through hole shape in which the longitudinal direction and the lateral direction of the cavity 6a are formed in an elliptical cross section, but may be formed into a square shape, a circular shape, an elliptical shape or the like having various cross-sectional shapes. Through hole shape. Further, the entire interior of the substrate 6 may be a cavity having a hollow chamber shape, and the entrance of the cavity may be formed on the upper, lower, left, and right sides of the substrate 6, and may communicate with the outside. Further, the cavity 6a extending in the lateral direction of the substrate 6 may be omitted, and if there is a cavity 6a penetrating in the longitudinal direction, the bone tissue is guided from the upper and lower cervical vertebrae C3-C4 or the lumbar vertebrae LiL5 to the porous body 1 mounted inside. It can be healed and fixed. Further, the inlets and the right lbs of the left and right sides of the substrate 6 may be omitted. The above-mentioned substrate 6 is composed of a biodegradable/absorbable polymer containing 42 326\main file\91\91134292\91134292 (replacement)-2 1252112 of biologically active bioceramic powder particles as a raw material. A biodegradable/absorbable polymer in vivo, using the same polymer as the above-mentioned implant material 10, that is, a poly-L-lactic acid or a polycrystal having a crystallinity confirmed to be safe in vivo. Preferably, glycolic acid or the like is preferable, and a matrix 6 having a high strength of poly-L-lactic acid having a viscosity average molecular weight of 150,000 or more (more preferably about 200,000 to 600,000) is preferably used. Such a matrix 6 can be produced by injection molding with a biodegradable/absorbable polymer in vivo, or by cutting a shaped block of a biodegradable/absorbable polymer in vivo, and the like. In the process of forming a block into a shape by compression molding or forging, the polymer molecules or crystals are aligned to form a mass, and the substrate 6 obtained by the cutting process is densely formed and polymer molecules or crystals. It is better to make the three-dimensional alignment to increase the strength. Further, it is also preferable to use a block which is formed by stretching as a shaped block and to perform cutting in such a manner that the extending direction (alignment direction) is the longitudinal direction to improve the strength. As the bioceramic powdery particles contained in the matrix 6, the above bioactive, fully bioabsorbable bioceramic powdery particles can be used in the same manner as the above-described implant material 1 〇 spindle 2 Preferably, it is preferably 10 to 60% by weight. If it is less than 1% by weight, the bone conduction of the bioceramic powdery particles is insufficiently formed. If it exceeds 6% by weight, the matrix 6 is weakened. On the other hand, the porous body 1 filled in the voids 6 & of the substrate 6 is the same as the above-described organic-inorganic composite porous body, that is, in the biodegradable/absorbable polymer in vivo, substantially Dispersed bioactive organism 326\main file\91\91134292\91134292(replacement)-2 43 1252112 Ceramic powdery particles made of biodegradable/absorbable porous body in vivo, with continuous pores and pores Some of the bioceramic powder particles are exposed on the inner surface or the inner surface of the pores and the surface of the porous body. The porosity of the porous body 1, the pore diameter of the continuous pores, the proportion of the continuous pores to the entire pores, the biodegradable/absorbable polymer in vivo, the bioceramic powdery particles, and the content of the powdery particles are as described above. Said. Further, the porous body 1 above and below the substrate 6 is formed with a hole passing through the projection 6f of the substrate 6, and is superposed on the upper and lower surfaces 6d, 6e of the substrate 6, and fixed by means of heat fusion or the like. The thickness of the porous body 1 above and below the substrate 6 is 0. 5~3mm is better. In the case of thinner than 0. 5 mm, it is difficult to absorb the unevenness of the surface of the cervical vertebrae C3-C4 or the lumbar vertebrae L4-L5 due to compression deformation. Therefore, it is associated with cervical C3-C4 or lumbar vertebrae L4-L5. Contrary to the concern of lowering the adhesion, on the contrary, in the case of a thicker than 3 mm, the time required for decomposition and absorption and replacement with bone tissue becomes longer. It is preferable that the porous body 1 which is attached to the cavity 6a of the substrate 6 or the porous body 叠 which is superposed on the upper and lower sides of the substrate 6 contains the above-mentioned bone forming factor, growth factor, drug, etc. The surface of the porous body 1 is subjected to the above oxidation treatment to improve the wetting characteristics. The implant material 1 1 is inserted into the left and right pairs between the cervical vertebra C3 - C4 or the lumbar vertebra L4 - L5 by using an insertion jig, thereby bridging the cervical vertebra c 3 - C 4 or the lumbar vertebra L4-L5. Interval or posture. If the implant material n is inserted in this way, the porous body 1 on the upper and lower sides of the substrate 6 will be compressed by the clamping pressure of the cervical vertebra c 3 _ c 4 or the lumbar vertebra L4-L5, so that the cervical vertebra c3-c4 or the lumbar vertebra L4 -L5 has no gaps to fit 'and the protrusions 6f on the upper and lower sides of the matrix 6 will be embedded in the cervical vertebrae c3_c4 or the lumbar vertebrae L4-L5's sponge bone, so that the implant material will not be displaced or 44 326\total file\91 91134292\91134292 (replacement)-2 1252112 疋 之下 ' 'Because the matrix 6 is a rectangular parallelepiped shape can be set. When the implant material 1 1 is inserted between the cervical vertebrae C3-C4 or the lumbar vertebrae L4-L5, the matrix 6 having the same function as the cortical bone of the living body will be in contact with the body fluid, and slowly start from the surface. Hydrolysis is carried out. Secondly, the porous body 1 having the same function as the sponge bone is rapidly hydrolyzed by the body fluid which is saturated with the continuous pores through the exposed pores, and the bone bud cells invade the porous body via the bone conduction energy of the bioceramic powdery particles. The inside of 1 is conductive to form bone tissue, so the porous body 1 is replaced with bone tissue in a short period of time. Therefore, the upper and lower cervical vertebrae C3-C4 or the lumbar vertebrae L〇L5 can be healed and fixed by the bone tissue thus replaced. On the other hand, the matrix 6 has a compressive strength as high as that of the conventional carbon cage since the beginning, and the porous body 1 can continue to maintain strength after the bone replacement, and the implant material 1 1 can be completely combined with the cervical vertebra. C1-C4 or lumbar vertebrae L4-L5 healed and mechanically fixed, and exerted a large effect, which was then completed after several years (about 5 years) and bone tissue replacement. At this time, it is possible to completely heal due to the solid shape of the living bone. The conduction formation of the bone tissue is caused by the compression of the porous body 1 on the upper and lower sides of the matrix 6 so that the cervical vertebra C3_C4 or the lumbar vertebra L4-L5 are in close contact with each other, and the porous body 1 is the same as the above-described organic-inorganic composite porous body. The bioceramic powder particles having bone conduction energy are 60 to 9% by weight, and the porosity is 50 to 90%. The continuous pores occupy 50 to 90% of the entire pores, and the pore diameter of the continuous pores is about 100 to 400 //m. Therefore, the bone bud cells are easily invaded and can be surely performed. The bone tissue is formed in the initial stage of the surface layer portion of the porous body raft on the upper and lower sides of the substrate 6, and the implant material 11 is directly bonded to the upper and lower cervical vertebrae c3_c4 or the lumbar vertebrae l5. 45 1 26\总档\91 \91134292\91134292 (replacement)_2 1252112 As described above, the implant material 11 is replaced by the bone tissue because both the matrix 6 and the porous body 1 are decomposed and absorbed, not as a foreign matter. It exists in the living body, so the titanium or carbon cage used as a vertebral fixation material has the concern of the long-term existence of harmfulness in the living body, or the vertebra caused by the inconsistency between the living body and the mechanical properties. The problem of sinking in the body was swept away. Moreover, 'the porous body 1 can perform the same histological action as the living bone, and replace it with the bone tissue. Therefore, in order to fill the cage, it is necessary to take the intestinal bone or the like as the bone for transplantation; The problem of insufficient acquisition of the bones for transplantation or the cumbersome handling of the surgery after the extraction is also swept away. The implant material 1 1 is a substrate 6 on the upper and lower sides 6d, 6e is a horizontal plane, but can also tilt the upper side 6 d forward, so that the lower 6 e is inclined upward to make the front end narrowed into a matrix 6 if In this way, it can be an implant material suitable for correcting the lumbar spine in a forward curved posture. Further, the shape of the substrate 6 is not limited to the above-described rectangular parallelepiped shape, and may be various shapes suitable for the cervical vertebrae, the lumbar vertebrae, the spine, and other places of use. As shown in Fig. 7, the implant material 12 is a shape of a change matrix, and the substrate 6 has a cylindrical shape having a cavity 6a (a circular cavity in cross section) on the inner side, and a large circle is disposed on each end surface thereof. The entrance 6b of the shaped hollow has an entrance 6b having a small oblong hole on the outer peripheral surface, and is arranged in a staggered manner. Then, the organic-inorganic composite porous body 1 is mounted on the cavity 6a of the substrate 6, and the porous body 1 is exposed from each of the inlets 6b formed on both end faces and the outer peripheral surface of the substrate 6. Such implant material 12 is inserted into the cervical vertebra as shown in the figure and 46 326 \ total file \91 \91134292\91134292 (replacement)-2 1252112 between the vertebral bodies such as lumbar vertebrae, and the above implant material 1 1 Similarly, the matrix 6 or the porous body 1 will eventually be replaced with the bone tissue to heal and fix the upper and lower cones. Further, depending on the situation, a male screw 'on the outer peripheral surface of the implant material 12 may be inserted into the upper and lower vertebral bodies in a lateral posture. The implant material shown in Fig. 8 is also a shape in which the matrix is formed, and the matrix 6 is formed into a ring shape having a low height of the portion 6n having a small curvature, and the porous body 塡 is mounted in the cavity 6a on the inner side thereof. The upper and lower entrances of the hollow are exposed to the upper and lower sides of the porous body 1. Although the outer peripheral surface of the ring-shaped substrate 6 is not formed with a hollow inlet, a plurality of hollow inlets may be formed depending on the case. Further, the above-described fixing protrusions may be formed on the upper and lower surfaces of the ring-shaped substrate 6. Such an implant material 13 moves the portion 6n having a small curvature of the matrix 6 to the posterior side to be inserted between the vertebral bodies such as the cervical vertebrae and the lumbar vertebrae, and the matrix 6 or the porous body is the same as the implant materials 丨丨 and 丄2 described above. 1 Finally, it will be replaced with bone tissue to make the upper and lower vertebral bodies heal and fix. The implant materials 1 1 , 1 2 , and 1 3 are all used as a vertebral body fixing material to be inserted and disposed between the cervical vertebrae or the lumbar vertebrae. If the shape of the matrix 6 is appropriately changed, it can also be used. In the bone joints of various parts. The implant material 丨4 shown in Fig. 9 is a substitute for the same kind of transplanted bone piece or self-transplanted bone piece, and has a block-shaped organic-inorganic composite porous body 1 and is biodegradable in vivo for burying the bone defect site. The skin layer 7 of the absorbent member is laminated on one of the surfaces of the porous body 1 to be integrated. The bulk porous body 1 is the same as the above-mentioned organic-inorganic composite porous body 47 326\total file\91 \91134292\91134292 (replacement)-2 1252112 'that is, the biodegradable/absorbable polymerization in vivo In the body, the biodegradable/absorbable porous body formed by the bioactive ceramic powder particles is substantially uniformly dispersed, and has continuous pores, and has a pore on the inner surface of the pore or the inner surface of the pore and the surface of the porous body. Exposed part of the bioceramic powder particles. The porous body 1 can be produced by the above-described manufacturing method of the present invention, which has a porosity, a pore diameter of a continuous pore, a ratio of a continuous pore to an entire pore, a biodegradable/absorbable polymer in vivo, and a bioceramic powder particle. The content of the powdery particles and the like are as described above. Since the porous body 1 can function as a sponge bone, the shape thereof is not particularly limited as long as it is a block shape, and can be formed into various shapes for the bone defect to be compensated. The porous body 1 may contain the bone forming factor, the growth factor, the drug, and the like described above in an appropriate amount, and may be subjected to the above oxidation treatment on the surface of the porous body 1 or the surface of the skin layer 7 to improve the wettability. The epidermis layer 7 functions as a cortical bone and is a layer of dense texture composed of a biodegradable/absorbable polymer in vivo containing biologically active bioceramic powder particles. In the implant material 14 , the skin layer 7 can be abunded on the convex curved side of the block-shaped porous body 1 and integrally provided 'may be stacked on the other side, the upper surface and the bottom surface of the porous body 1 In either case, it may be superposed on the two sides of the porous body 1 or even three or more. The point is that the skin layer 7 is merely laminated on one of the surfaces of the block-shaped porous body 1. The thickness of the skin layer 7 is not particularly limited, and the bone defect portion of the implant material 4 is buried and considered to be appropriately set at 1. 0~5· 〇mm's range is better. If the right side is thinner than 1 · 0 mm, there is a concern that the strength of the skin layer 7 is less than 326\total file\91\91134292\91134292 (replacement)-2 48 1252112. If it is thicker than 5 · 0 mm, the skin layer will be produced. 7 It is a bad situation that it is decomposed and absorbed and replaced with bone tissue for a long time. Since the skin layer 7 is required to have a larger strength than the bulk porous body 1, the biodegradable/absorbable polymer as a raw material is preferably a crystalline polylactic acid or a polyglycolic acid, particularly for use. A high-strength skin layer 7 of poly-L-lactic acid having a viscosity average molecular weight of 150,000 or more (more preferably about 200,000 to 600,000) is preferred. As the bioceramic powdery particles contained in the skin layer 7, the biologically active bioceramic powdery particles contained in the porous body 1 can be used, and the content thereof is in the range of 1% to 6% by weight. good. If it exceeds 60% by weight, the skin layer 7 is weakened, and if it is less than 1% by weight, the formation of bone conduction due to the bioceramic powdery particles is insufficient. The skin layer 7 is capable of injection molding a biodegradable/absorbable polymer containing bioceramic powder particles, or a shaped block of a biodegradable/absorbable polymer containing bioceramic powder particles in vivo. The material is produced by a method such as cutting. In the latter method, the shaped block is formed into a lump by means of compression molding or forging, and the polymer molecules or crystals are aligned to form agglomerates, and the skin layer 7 obtained by the cutting process is dense and polymer molecules due to texture. Or it is better to crystallize into a three-dimensional alignment to increase the strength. Further, a skin layer obtained by subjecting an elongated shaped molded block to a cutting process can also be used. This implant material 14 is formed by laminating the skin layer 7 produced by the above method on the convexly curved side surface of the bulk porous body 1, and is formed into an inseparable composite by means of heat fusion or the like. Means for integrating the skin layer 7 with the porous body 1 49 3 26\total file \91 \91 ] 34292\91134292 (replacement)-2 1252112 is not limited to the heat fusion method' and may be integrated by other means. The implant material 14 having the above structure is implanted as a substitute for the same kind of bone graft or self-transplanted bone piece, and is embedded in the bone defect site, and the sponge bone portion of the bone defect portion is filled with the massive porous body 1 and the bone defect is compensated. The cortical bone part of the site is compensated by the epidermal layer 7, because the massive porous body 1 acts as a sponge bone, and the strong epidermis layer 7 functions as a cortical bone, just as the sponge bone portion of the bone defect portion is filled with a sponge bone. The cortical bone part is supplemented with cortical bone. In this way, the bone defect portion is filled with the implant material 14. In the bulk porous body 1, the body fluid is permeated through the continuous pores to the inside, and the bone conduction energy through the bioceramic powder particles is simultaneously performed while rapidly hydrolyzing. The bud cells invade the inside of the porous body 1 to allow the bone tissue to be formed. Therefore, the bulk porous body 1 can be substituted with the bone tissue in a short period of time. On the other hand, the skin layer 7 is slower than the bulk porous body 1, and is slowly hydrolyzed from the surface, and sufficient strength can be maintained during the period in which the bulk porous body 1 and the bone tissue are replaced to some extent, and finally, The bone tissue is replaced and disappears. This implant material 14 does not have the above-described specific living body reaction, and can be invaded and replaced by the surrounding living bone in the course of non-specific decomposition, absorption, and discharge. That is, both the bulk porous body 1 and the skin layer 7 are decomposed and absorbed and replaced with bone tissue, and since they do not remain as a foreign body in the living body, the conventional ceramic implant material is worried about the long-term in vivo. The fear of the occurrence of the residual hazard can be removed, and the bone defect site can be repaired and reconstructed by replacing the self-bone tissue. Moreover, the implant material 14 is based on both the porous body 1 and the skin layer 7 being biodegradable/absorbed as a raw material in the living body 50 326\total file\91\91134292\91134292 (replacement)-2 1252112. Therefore, it is not necessary to use the dead bone as the raw material for the same kind of transplanted bone piece. (4) The material is insufficiently considered, and the necessary and sufficient amount of the implant material can be mass-produced as needed, through forming and cutting, etc. , can be made into the desired shape and size. Further, although the skin layer 7 of the implant material 14 contains bioceramic powder particles, it is composed of a ceramic material which is biodegradable/absorbable in vivo. The shortcomings of being too hard and brittle are things that are not easily cracked by the initial nature. Further, although the bulk porous body 1 also contains a large amount of bioceramic powdery particulate matter, it is a porous body which is a raw material which is biodegradable/absorbable in vivo, so that even if the porosity is high, it is not as high-porosity. The ceramic is very brittle, and it will not peel off when it is buried. If necessary, it can be heated and deformed. The implant material of the present invention has no brittleness, has sufficient practical strength, and can be heated and deformed, and is excellent in usability. Further, the implant material 14 can be used as a surgical substitute for a multi-purpose use, and it is now particularly effective in the use of a patch and a spacer for cervical vertebrae and lumbar vertebrae which have been used for a number of problems. Fig. 1 〇 and the implant material 15 shown in Fig. 1 is used as a patch for the repair, bridge or enlargement of a defect or a deformed portion of a plurality of bone parts such as a skull, ankle, a face or a chest. The implant material of the ruthenium filling material and the like has an organic-inorganic composite porous body 1 and a mesh body 8 which is a biodegradable/absorbable member in vivo, and is filled in the mesh 8 a of the mesh body 8 There is a porous body 1 and it is made in one body. The mesh body 8 of the implant material 15 is biodegradable/absorbable in vivo by containing the biologically active bio-ceramics 51 3 26\total file\91\91134292\91134292(replacement)-2 1252112 porcelain powder particles. The densely structured mesh body of the polymer is formed into a square mesh 8 by means of a sheet or a plate containing a biodegradable/absorbable polymer in the bioceramic powdery particle or by cutting or the like. a and made a mesh. The shape of 8 a is not limited to a square shape, and may be formed into a circular shape, a diamond shape, and a desired mesh shape. The opening area of the mesh 8a is 0. 1~1. Preferably, the area of about 0 cm 2 is preferably about 10 to 80% of the area of the mesh body 8 . Also, the thickness of the net is taken as 〇. 3~1. Preferably, it is about 5 mm, and the width of the mesh body 8 is 8 b and the width of the cross-cord portion 8 c is about 2 to 10 mm. If the area ratio of the mesh 8 a is less than 10%, then Although the uniformity of the implant material 15 is large, the amount of the porous body 1 which is fast in the hydrolysis of the mesh 8 a is small, and the proportion of the slow-removing mesh body 8 becomes large, so the plant material 1 5 is completely decomposed and absorbed and takes a long time to replace with bone tissue. On the other hand, if the area ratio of the mesh 8 a is more than 80%, the thickness of the mesh is 0. When the thickness of 3 mm is equal to the width of the longitudinal yarn portion 8b and the width corresponding to the transverse portion 8c is smaller than 2 mm, the strength of the mesh body 8 is large, so that it is difficult to obtain the implant material 15 having high strength. In the case of obtaining the mesh body 8 having good bending workability, as the above-mentioned sheet or plate as a material, a biodegradable/absorbable polymer containing bio-powder-like particles in vivo may also be used. After the forged body is forged in the low temperature range (the temperature range from the glass transition temperature of the polymer to the melting temperature), the direction is further changed (mechanical MD) for forging, and the hole is formed or cut into a mesh. 326\总档\91\91134292\91134292 (replacement) - 2 made of perforated meshes and other eyes 8a (body 8 yarn parts are good. Body strength will become t body 8 yarn part lowering In the direction of Tao Rongcheng, a good 8 a 52 1252112 to make a mesh body. The sheet or plate of the biodegradable/absorbable polymer in vivo can be forged twice. The molecular chain of the biodegradable/absorbed polymer, the domain of the molecular chain collection, the crystallization, etc., the multiaxial alignment or the cluster of the multiaxial alignment, so if it is in the normal temperature region (〇~ 5) Make it bend and deform 'The shape is maintained near the body temperature (30~40 〇c) and it will be difficult to return to the original shape'. Even if it is bent and deformed many times, it is not easy to whiten or cut. Therefore, 'use this sheet or plate The implant material 15 formed by forming the mesh body 8 of the mesh 8 a is excellent in bending workability, so as shown in FIG. 12, it can be used at normal temperature during surgery to be associated with the skull 20. The curved surface of the defect portion 21 is flexed and fixed to the defect portion 21. Further, as the sheet or plate of the material of the mesh body 8, it is of course possible to use a single axis or a two axis. Extender, no stretcher, or compression-molded. In vivo biodegradable/absorbable polymer as a raw material of the mesh body 8, crystallized poly-L-lactic acid, poly-D-lactic acid, which has been confirmed to be safe Preferably, poly-D/L-lactic acid, polyglycolic acid, etc., in consideration of the strength and hydrolysis rate of the mesh body 8, etc., the biodegradable/absorbable polymer in the living body has a viscosity average molecular weight of 15 More than 10,000 are better, and those with a degree of 200,000 to 600,000 are better. As this mesh The bioceramic powdery particles contained in the biodegradable/absorbable polymer in vivo 8 can be used as the biologically active bioceramic powdery particles contained in the porous body 1, and the content thereof is made into 10~ 60% by weight is preferred. If it is less than 10% by weight, the formation of bone conduction due to the bioceramic powdery particles may be insufficient. If it exceeds 60% by weight, it will be 326\total file\91\91134292\91134292 (replacement) · 2 53 1252112 The disadvantage of the weakening of the raw mesh body 8. Further, for example, a mesh in which the intersection of the longitudinal yarn of the biodegradable/absorbable polymer containing the bioceramic powdery particles and the transverse yarn is merged may be used. The mesh body 8 is replaced by a shape or the like. On the other hand, the porous body 1 which is filled in the respective meshes 8a of the above-mentioned mesh body 8 is the same as the above-mentioned organic-inorganic composite porous body, that is, a polymer which is biodegradable/absorbable in vivo. The porous body which is biodegradable/absorbable in vivo is substantially uniformly dispersed in the biologically active bioceramic powder particles, and has continuous pores, and has a part on the inner surface of the pore or the inner surface of the pore and the surface of the porous body. Part of the bioceramic powdery particles are exposed. The porosity of the porous body 1, the pore diameter of the continuous pores, the proportion of the continuous pores to the entire pores, the biodegradable/absorbable polymer in vivo, the bioceramic powdery particles, and the content of the powdery particles are as described above. . In the porous body 1, 'the bone forming factor, the growth factor, the drug, and the like described above may be contained in an appropriate amount, and the above oxidation treatment may be applied to the surface of the porous body 1 or the surface of the mesh body 8 to improve the wettability. . The implant material 15 of the above configuration is attached to the skull 2 in a manner to cover the defect portion 21 of the skull 20 as shown in Fig. 12, and the peripheral portion thereof is biodegradable/absorbable by the living body. The screw 30 made of the polymer is fixed at several places. At this time, it is preferable to bend the implant material 15 in such a manner as to conform to the curved surface of the defect portion 2丨 of the skull 2 〇. By covering the defect portion 21 of the skull 20 with the implant material 15 in this manner, the mesh body 8 is slowly hydrolyzed from the surface via contact with the liquid. The porous body 1 is saturated with the body fluid through the continuous pores. To the inside, so 326 \ total file \91 \91134292\91134292 (replace) · 2 54 1252112 hydrolysis will proceed quickly. Then, the bone conduction energy of the bioceramic powdery particles contained in the porous body 1 causes the bone bud cells to intrude into the interior of the porous body 1 to cause the bone tissue to be formed, and the porous body 1 is replaced with a short period of time. Bone tissue. On the other hand, the mesh body 8 is slowly hydrolyzed with respect to the porous body 1. The porous body 1 can maintain sufficient strength to protect the defective portion 21 of the skull bone 20 before the bone tissue reaches a certain degree of replacement. Finally, the mesh body 8 is also replaced with the bone tissue and disappears. As described above, the porous material 丨 and the reticular body 8 are all decomposed and absorbed, and replaced with bone tissue, and are not left as a foreign body and remain in the living body@', so that it can be used as a bone defect portion. The punching used in the patch material is a concern that the occurrence of the harmfulness of the long-term existence in the living body, and the defect portion 21 of the skull bone 20 can be repaired and reconstructed through the replaced bone tissue. Further, the mesh body 8 of the implant material 15 contains bioceramic powder particles, which are composed of a biodegradable/absorbable polymer in vivo, but are not as hard as a dense ceramic by sintering. The shortcoming of brittleness is that it is tough and not easy to crack, and can be heated and deformed at normal temperature. Further, although the porous body 1 also contains a large amount of bioceramic powdery particles, since the biodegradable/absorbed polymer in the living body is formed into a matrix, even if the porosity is high, it is not as high as the high-magnification porous ceramic. It is brittle and will not peel off when it is buried. It can also be heated and deformed if necessary. The implant material 15 of the present invention is excellent in the usability which is not brittle and has sufficient practical strength and can be heat-deformed. The implant material 15 is made into a mesh body by a part which functions as a cortical bone having a strength, and a porous body which functions as a sponge bone is made into a height of 55 326\total file\91\91134292\91134292 (replacement) ) 2 1252112 Void ratio ', can obtain a high-area and less material substitute for living bone, is the combination of the mesh body and the porous body, the total amount of material is limited to a very small amount, in the process of decomposition and absorption, the living body A very small amount of implant material with excellent biocompatibility. In addition, the implant material 15 can be used in addition to the use example shown in Fig. 12, and can also be used in the repair of collapsed fractures in the face, bones and the like, etc. The repair and reconstruction of the bone defect site can also be used as a substrate for bone elongation. In the implant material i 5 of the type in which the porous body 1 and the mesh body 8 are combined, 'not only the porous body 1 is filled into the mesh 8 a of the mesh body 8 but in the mesh 8 There is also a structure in which the porous body 1 is provided in a layer shape on both sides or on both sides, and is a very useful embodiment. 1 and FIG. 1 show an implant material 16, 17 of such an embodiment, the implant material 16 is on one side of the implant material 15 'the above-described organic-inorganic composite porous body 1 is layered The implant material 17 is on both sides of the implant material 15, and the above-described organic-inorganic composite porous body 1 is layered. The layered porous body 1 is a phase and the same as the above-mentioned organic-inorganic composite porous body 1, and is formed into a layered shape (sheet shape) by the above-described production method of the present invention. The layered porous body 1 can be laminated integrally on one side or both sides of the implant material i 5 by means of thermal fusion or the like. The thickness of the layered porous body 1 is not particularly limited, and is determined by the adhesion to the bone around the bone defect site, or the time required for the decomposition and absorption and the replacement of the bone tissue. A thickness of about 5 to 3 mm is preferred. Such implant materials 16.1,7 are formed to uniformly form bone tissue on one side or two 56 3 26\total file\91\91134292\91134292 (replacement)·2 1252112 in a relatively short period of time. Therefore, the repair and reconstruction of the surface of the bone defect can be performed quickly. In addition, the porous body 1 which is provided in a layered shape serves to act as a cushioning material to adhere to the bone around the bone defect site, and the bone bud cells easily invade the inside of the layered porous body i, so that it can be made earlier. The bone tissue is formed in the surface layer portion of the porous body 1, and the implant material 1-6 is directly bonded to the bone around the bone defect portion, and can be firmly fixed. Further, in the implant material 15 in which the porous body 1 and the mesh body 8 are combined, the mesh body 8 is made into a concave curvature or a convex curvature, and the porous body 1 is also filled on the inner side thereof. The constructor is also a useful embodiment. Figure 15 shows an implant material of such an embodiment. The implant material 18 is such that the mesh body 8 of the implant material 15 is concavely curved into a U-shape and is porous in its mesh. Similarly to the body 1, the porous body 1 is also filled inside the mesh body 8 (i.e., inside the concave curved shape). As the mesh body 8, a mesh or a plate-like material of a biodegradable/absorbable polymer having good flexural workability, which is subjected to secondary forging to change the mechanical direction, is formed into a mesh. The body is high in mechanical strength and can be flexed at room temperature, so it is particularly good. Such an implant material 18 is, for example, made to be immersed and filled with a defect such as a tibia, as shown by a broken line in Fig. 12, and can be used for repairing and reconstructing a defect portion of the tibia. . In addition, it is of course possible to use the defect part of the face of the skull, the middle face, the upper jaw or the lower jaw for the purpose of repairing and regenerating the living bone lost by accident or cancer, and other large bone defects in orthopedics. Part of the repair and reconstruction also applies. Further, the above-mentioned implant material 18, although the mesh body 8 is concavely curved into a U-shape, can conform to the shape of the reconstructed bone defect portion, and the mesh body 8 is concave 3 2 6\total file\91 \91134292\91134292(Replacement)-2 57 1252112 Curved or convex curved, which can be made into the implant material i 8 by filling the porous body 1 on the inner side, and in the case of the implant material 18, depending on the situation, The porous body i is further provided in a layer shape. In addition, an implant material can be formed in which the mesh body 8 is folded, and the folded mesh body 8 is also filled with a porous body, and the implant material can be stacked up and down. An implant material in which a sandwich structure of the layered porous body 1 is sandwiched therebetween. Fig. 16 and Fig. 1 show the implant material 丨9 for artificial cartilage. The implantable material for artificial cartilage includes the above-described organic-inorganic composite porous body 1, a core material 9 which is a non-absorbable member in vivo, and a fixing shaft 22 which is a biodegradable/absorbable member in vivo. The porous body 1 is laminated on the upper and lower surfaces of the core material 9 of the non-absorbent member in the living body, and the front end of the fixing shaft 2 2 protrudes from the surface of the porous body 1. This artificial cartilage implant material has a planar shape of a rectangular shape and a semicircular shape which is approximately a front circumflex shape as shown in Fig. 16. It is applicable as an artificial intervertebral plate. The core material 9 is composed of a three-dimensional woven structure or a braided structure or a tissue structure of such a composite structure, and has mechanical strength and flexibility similar to that of a cartilage such as an intervertebral plate, and the deformed living body is mimetic (bi 〇 Mimetics). The structure of the core material 9 is the same as that of the tissue structure described in the patent application No. 6-25 4 5 1 5, which is hereby incorporated by reference. It is shown that the number of orientations of the fiber arrays is represented by the number of axes, and it is preferable to use a structure composed of a multi-axis-three-dimensional structure of three or more axes. The 3-axis-three-dimensional structure system carries the longitudinal, transverse, and vertical directions of the fibers in the direction of 58 326\total file\91\91134292\91134292 (replacement)-2 1252112. The representative shape of the structure is as follows. The core material 9 has a thickness of a block shape (plate shape or block shape), and may be formed into a cylindrical shape or a honeycomb shape. The 3-axis-three-dimensional tissue system can be classified into orthogonal tissue, non-orthogonal tissue, interactive tissue, cylindrical tissue, etc. depending on the tissue. Further, the multi-axis-three-dimensional structure of four or more axes can improve the isotropicity of the strength of the structure by arranging the multi-axis directions of the 4, 5, 6, 7, 9, and the like. Further, by such selection, a cartilage tissue which is more like a living body and a more active molded core material can be obtained. The internal porosity of the core material 9 composed of the above-mentioned structure structure is preferably in the range of 20 to 90%, and in the case of less than 20%, the core material 9 is dense and the flexibility is impaired. Or deformability, so it is not suitable for the core material as the implant material for artificial cartilage, and in the case of more than 90%, since the compressive strength or shape retention of the core material 9 is lowered, it is not suitable for artificial cartilage. Into the core material of the material. As the organic fiber constituting the core material 9, a living-inactive synthetic resin fiber such as a fiber such as polyethylene, polypropylene, or polytetrafluoroethylene can be used; and the organic core fiber is coated with the above-mentioned living body-inactive resin to form Living inactive covering fibers and the like are preferred. In particular, the core fiber (twisted yarn) of the ultrahigh molecular weight polyethylene is covered with a linear low-density polyethylene film having a diameter of 0. The cover fiber of 2 to 0 · 5 m m is the optimum fiber in terms of strength, hardness, elasticity, ease of weaving, and the like. Alternatively, other fibers that are biologically active (e.g., having bone conduction or induction) can be selected. In addition, the structure of the structure for constituting the core material 9 is disclosed in detail in the above-mentioned Japanese Patent Application No. Hei. 59 326\总档\91\91134292\91134292 (replacement)·2 1252112 The porous body 1 laminated on the upper and lower sides of the core material 9 is the same as the above-mentioned organic-inorganic composite porous body, that is, it is biologically active in vivo. In the degraded/absorbed polymer, the biodegradable/absorbable porous body formed by the biologically active bioceramic powder particles is substantially uniformly dispersed, and has a continuous pore and is in the inner surface of the pore or the inner surface of the pore. A portion of the bioceramic powdery particles are exposed to the surface of the porous body. The porous body 1 is produced by the above-described manufacturing method of the present invention, and has a porosity, a pore diameter of continuous pores, a ratio of continuous pores to the entire pores, a biodegradable/absorbable polymer in vivo, a bioceramic powdery particle, The content rate and the like of the powdery particles are as described above. The porous body 1 has a function as a spacer. When the porous body 1 is laminated on both sides of the core material 9, the implant material 16 is inserted between the cervical vertebrae or the lumbar vertebrae (refer to the cervical vertebra of FIG. 6). In the case of C3-C4 or lumbar vertebra L4-L5), the porous body 1 is compressively deformed by the nip pressure of the upper and lower vertebral bodies, and is closely adhered to the vertebral body without contact, and the porous body 1 is in contact with the body fluid, and the bone tissue is hydrolyzed. The bone conduction energy of the bioceramic powdery particles can be conductively formed into the interior of the porous body 1, and the porous body 1 is replaced with the bone tissue in a short period of time, and directly bonded to the vertebral body and the core material 9. At this time, the surface of the core material 9 is sprayed with the bioceramic powdery particles to form a bioactive surface layer, which is because the conductive living bone bonds to the activated surface layer, so the vertebral body and the core material 9 The direct combination can be carried out in a short period of time and the strength can be maintained. Further, 'the osteoinductive factor is contained in the porous body 1' can exhibit osteoinductivity and is more effective. The thickness of the porous body 1 is preferably about 5 to 3 mm, more preferably 0. 5 mm thin case, because it is difficult to absorb the surface of the vertebral body due to compression deformation 60 326 \ total file \91 \91134292\91134292 (replacement) - 2 1252112 bumps and so the adhesion with the vertebral body has a concern, and vice versa In the case of 3 mm thicker, it takes longer to decompose and absorb and replace with bone tissue. Further, the porous body 1 is laminated so that approximately half of the thickness thereof is buried in the core material 9 as shown in Fig. 17, and the porous body 1 is preferably surrounded by the peripheral portion of the core material 9. This method can suppress the wear of the periphery of the porous body 1. Further, in the porous body 1, the bone forming factor, the growth factor, the drug, and the like described above may be contained in an appropriate amount, and in this case, the bone formation inside the porous body 1 can be remarkably promoted, and the direct bonding of the core material 9 and the vertebral body can be compared. Play early. Further, the above-mentioned oxidation treatment may be applied to the surface of the porous body 1 to improve the wettability characteristics, and the invasion and growth of the bone bud cells to be proliferated may be more effective. The fixing shaft 2 2 penetrates the core material 9 and the porous body 1 on both surfaces thereof, and both ends thereof protrude from the porous body 1. When such a fixing nail 22 is inserted, when the implant material 19 is inserted between the upper and lower vertebral bodies, the front end of the fixing nail 22 protruding from the porous body 1 is deepened by the nip pressure of the upper and lower vertebral bodies. The contact surface of the vertebral body', so that the implant material 19 can be fixed between the vertebral bodies without positional displacement. The number of fixing pins 2 2 is preferably two or more, and the optimum number is three as shown in the figure. This case is advantageous in that it can be stably installed between the upper and lower vertebral bodies via the three-point support. . The both ends of the fixing nail 22 are preferably formed into a tapered shape such as a conical shape, and the diameter of the shaft 22 is preferably about 1 to 3 mm in order to ensure the strength. Furthermore, the protruding size ' at both front ends of the fixing nail 22 is 0. 3~2mm is better. At the beginning of the insertion of the implant material 19 into the vertebral body, since the clamping force of the upper and lower vertebral bodies acts on the fixing shaft 2 2, the anchor shaft 61 326 of the strength is large and the total file is \91 \91134292 \91134292 (replace) - 2 1252112 is necessary. Therefore, the fixing nail 22 is biodegradable in vivo using a crystalline polylactic acid such as a viscous average molecular weight of 15,000 or more (more preferably 200,000 to 600,000). Absorbed polymers are preferred, and it is also preferred to use such polymers to biomix the bioceramic powder particles. Further, the blending, forging, stretching, and the like may be used to blend the polymer molecules to increase the strength. When the artificial cartilage of the above-described structure is attached to the upper and lower intervertebral plates as the artificial intervertebral plate, as described above, both ends of the fixing shaft 2 2 protruding from the surface of the porous body 1 are deep into the vertebral body. The contact surface, so that the implant material 19 can be fixed between the vertebral bodies without positional displacement. Therefore, it is not necessary to use a fixing fixture or the like to fix the living material, so that surgery can be easily performed. Further, when the implant material 19 is mounted between the vertebral bodies in this manner, the porous body 1 on the surface of the core material 9 is compressed by the nip pressure of the upper and lower vertebral bodies, and is closely adhered to the vertebral body without gaps. As the decomposition and absorption of the porous body 1 progresses, the bone tissue is conductively formed inside the porous body 1, and the porous body 1 is replaced with the bone tissue for a short period of time and directly bonded to the vertebral body and the core material 9. However, since the core material 9 is a living-inactive synthetic resin fiber, bone tissue is not formed into the inside thereof, and the flexibility can be maintained. As described above, the core material 9 is composed of a multiaxial-three-dimensional woven structure or a braided structure having three or more axes or a structural structure of such a composite structure, and thus has a mechanical degree similar to that of a cartilage such as an intervertebral plate. The strength and flexibility, and the deformation is relatively easy, so that the action of the intervertebral plate can be exerted by performing substantially the same behavior as the intervertebral plate. Then, the fixing shaft 2 2 can be decomposed and absorbed in the living body in a short period of time, so that it does not remain. 62 326\总档\91\91134292\91134292 (replacement)-2 1252112 As described above, the artificial material cartilage implant material 9 9-core material 9 is a living body mimetic, so that its behavior resembles cartilage tissue, and has The direct binding energy of the endplate of the vertebral body bone and the initial self-standing, the tip of the fixation shaft 2 2 will be spurred to the bone tissue, which can prevent the lateral displacement and shedding of the body, and the porous body 1 will directly bind to the bone tissue. Can be integrated in histology. Therefore, the implant material 19 completely eliminates the disadvantages of the self-supporting artificial intervertebral plate of the sandwich structure as described above. Further, in the implant material for artificial cartilage, the porous material 1 is formed on the two-layer layer of the core material 9, and the both ends of the fixing nail 22 protrude from the porous body 1 but can also be formed in the core material 9. The single-area layer has a structure in which the porous body 1 is protruded from the front end of one of the fixing nails 22. The implant material for artificial cartilage having such a structure can be fixed to one of the vertebral bodies by the fixing nail 22, and the fixing strength is lowered, but the positional deviation of the implant material 丄9 can be prevented. . Further, the thickness of the porous body 1 may be gradually increased as the front square portion approaches the rear circular portion. If so, the space portion between the upper and lower vertebral bodies will be formed such that the front side is narrower and then The side is wider, so it can be an implant material that is completely fitted to the space portion. In addition, in the case where the short fixing nail is embedded in the surface layer portion of the core material 9, the tip end of the nail protrudes from the porous body 1 instead of the through-fixing nail 2 2 . . The above is a description of the implant material for artificial intervertebral plates, but needless to say, as long as the shape is appropriately changed, it can be used as a meniscus or a variety of articular cartilage other than the artificial intervertebral plate. material. The above description of the specific embodiment of the dream is described in detail, and the next day the 326\main file\91\91134292\91134292 (replacement)-2 63 1252112 is known to those skilled in the art, without departing from the invention. Spirits and norms can be changed or corrected. This application is based on the Japanese application filed on November 27, 2001 (I wish 2001-360766), and on December 3, 2001, the application for Japanese patent application (Special Wish 2001-368558), 2002 02 Japanese Patent Application (Japanese Patent Application No. 2002 _ 04 3 1 3 7) filed on the 20th of the 20th, and Japanese Patent Application filed on the 23rd of February 2nd (Special Wish 2002-242 800) September 30, 2002 Japanese Patent Application (Special 2002-285933) filed on the Japanese Patent Application, Japanese Patent Application No. 2002-2 8 5 934, filed on September 30, 2002, the content of which is hereby incorporated by reference. [Industrial Applicability] The implant material of the present invention can be practically used as a substrate structure, a patch material, a bone material, a mesenchymal material between other implant materials and a bone group, and a sponge bone for reuse of living bone tissue. A substitute, a carrier for slow release of a drug, and the like. The implant material of the present invention is integrated with other biodegradable/absorbable materials and/or non-absorbable members in vivo, and is actually used as a bone fixing material, a vertebral body fixing material, and various living bones. Spacer, bone loss site 塡 supplement material, patch material or enamel filling material, artificial cartilage material, etc. BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a perspective view showing an embodiment of an implant material of the present invention. Figs. 2(a), (b) and (c) are explanatory views showing an example of use of an implant material of the same embodiment. Fig. 3 is a perspective view showing another embodiment of the implant material of the present invention. 326\总档\91\91134292\91134292(replacement)-2 For the benefit of the profit of 08, we will build a weaving y. The body of each frame is missing. 64 1252112 Figure 4 is a diagram of the matrix of the implant material of the same embodiment. 5 is a longitudinal cross-sectional view of an implant material of the same embodiment. FIG. 6 is an explanatory view showing an example of use of the implant material of the same embodiment. FIG. 7 is a view showing another embodiment of the implant material of the present invention. Fig. 8 is a perspective view showing still another embodiment of the implant material of the present invention. Fig. 9 is a perspective view showing still another embodiment of the implant material of the present invention. Showing the implant material of the present invention again. 苴 He implements a perspective view of the form. Figure 11 is a cross-sectional view of the implant material of the same embodiment. Fig. 12 is an explanatory view showing an example of use of the implant material of the same embodiment. Figure 13 is a cross-sectional view showing another embodiment of the implant material of the present invention. Fig. 14 is a cross-sectional view showing still another embodiment of the implant material of the present invention. Fig. 15 is a cross-sectional view showing still another embodiment of the implant material of the present invention. Figure 16 is a perspective view showing still another embodiment of the implant material of the present invention. Figure 17 is a cross-sectional view of the implant material of the same embodiment. Component symbol description 1 Porous body 65 326\Total file\91\91134292\91134292 (replacement)-2 1252112 lb Into 2 Shaft 2a Concave and convex 3 Steel wire 4 Conveying belt 5 Hole 6 Substrate 6 a Empty hole 6b Empty hole in 6 c matrix, r · 刖 6d substrate upper 6 e substrate lower 6f fixing protrusion 6g pocket 6h shaft nail 6i wall portion 6 j communication hole 6 n small curvature portion 7 skin layer 8 mesh body 8a net Eye 8b corresponds to the longitudinal yarn portion 8 c corresponds to the horizontal yarn portion 9 heart material 3 26 \ total file \91 \91134292\91134292 (replacement) - 2 66 1252112 1 0~1 9 implant material 20 skull bone 2 1 defect portion 22 fixed Shaft 30 Screw B Half sternum 67 326V total file \91\91134292\91134292 (replace)-2