JPH0323864A - Filler for living body tissue - Google Patents

Abstract

PURPOSE:To keep the shape and strength of a filler over a long period of time and to absorb the filler by a living body after healing by constituting the filler of a composite material consisting of collagen sponge and a biodegradable- absorbable polymer material. CONSTITUTION:A filler is composed of a composite material consisting of collagen sponge and a biodegradable-absorbable polymer material and, as the biodegradable-absorbable polymer material, fibrous poly-L-lactic acid is used. This material is mixed with the collagen sponge or embedded therein to constitute the filler. By mixing poly-L-lactic acid slow in a degradation speed within sponge and compounding the same therewith, the pores in a sponge structure can be kept over a long period of time. The propagation of a fibroblast is accelerated by the compounding with fibrous poly-L-lactic acid and the strength and shape of the filler can be kept over a long period of time required in healing.

Description

Translated fromJapanese

【発明の詳細な説明】（産業上の利用分舒）本発明は、損傷、欠損等の外科的治療、整形外科手術等
に便川される充填材に関一づ−る。DETAILED DESCRIPTION OF THE INVENTION (Industrial Application) The present invention relates to a filling material used for surgical treatment of injuries, defects, etc., orthopedic surgery, etc.

（従来技術）損傷、欠損等の外科的治療、及び、整形外科手｛ホＩ等
においては組織の再生、拘縮を防止する目的において、
欠損部に充填材が埋入される。(Prior art) For surgical treatment of injuries, defects, etc., and for orthopedic surgery, etc., for the purpose of tissue regeneration and prevention of contracture,
A filling material is inserted into the defect.

かかる素材としては、紹織反応が少なく、線維芽細胞の
増殖を促し．　，ＩＩＩ織が再生するまで長Ｍにわたっ
てその強度、形状が維持される機能が求められる。また
、特に適用中においては糺織の拘縮を防止する目的にお
いて保形性を有する機能が求められ、また、組織の再生
後においては異物として体内に残留することなく速やか
に消失することが理想とされる。Such a material has a low fibrous reaction and promotes the proliferation of fibroblasts. , III is required to maintain its strength and shape over the length M until the weave is regenerated. In addition, shape-retaining properties are required to prevent the contracture of the daisy weave, especially during application, and ideally, after tissue regeneration, it should disappear quickly without remaining in the body as a foreign substance. It is said that

かかる目的に対し、　ミクロポーラスなコラーゲンスポ
ンジが提案されているが、」二記の機能を満足しない。Microporous collagen sponges have been proposed for this purpose, but they do not satisfy the functions listed in item 2.

（発明が解決しようとする問題点）即ち、例えば、グルタールアルデヒドを用いて架橋させ
たコラーゲンスポンシは、生体に埋入後２〜３ケ月後に
は完全に生体に分解吸収されて消失してしまい治癒に必
要な長期の強度、保形性を維持しない。(Problems to be Solved by the Invention) That is, for example, a collagen spongy crosslinked using glutaraldehyde is completely decomposed and absorbed by the living body and disappears 2 to 3 months after being implanted in the living body. It does not maintain the long-term strength and shape retention required for healing.

本発明は、かかる従来の欠点を解消し、組織反応が少な
く、且つ、線維芽細胞の増殖を促すと共に、長期にわた
って形状、強度が維持され、また治癒後は生体に吸収さ
れる新規な充填材を提供したものである。The present invention solves these conventional drawbacks, and provides a novel filling material that causes less tissue reaction, promotes the proliferation of fibroblasts, maintains its shape and strength over a long period of time, and is absorbed by the body after healing. was provided.

（問題を解決するための手段）しかるに、本発明はコラーゲンスポンジと生体分解吸収
性高分子材料との複合材料より成り、かかる生体分解吸
収性高分子材料として繊維状のボリーＬ一乳酸を用いた
こと、およびこれをコラーゲンスポンジ中に混在、もし
くは埋入させて構成したことに特徴を有するものである
。(Means for Solving the Problem) However, the present invention consists of a composite material of a collagen sponge and a biodegradable and absorbable polymer material, and uses fibrous Bory-L monolactic acid as the biodegradable and absorbable polymer material. It is characterized by the fact that it is mixed with or embedded in a collagen sponge.

（イ乍用）本発明は、コラーゲンスポンジ中に生体内での分解速度
の遅いポリ−Ｌ一乳酸を混在させて複合化させたことに
よってスポンジ構造のｐｏｒｅを長期にわたって維持で
き、また、繊維状のボリーＬ一乳酸との複合化によって
内部への線維芽細胞の増殖を促すと共に、治癒に必要な
長期にわたっての強度、形状の維持を可能としたもので
ある。(For use) The present invention can maintain the pores of the sponge structure over a long period of time by mixing and compounding poly-L monolactic acid, which has a slow decomposition rate in vivo, into the collagen sponge. By combining with Bory-L-lactic acid, it is possible to promote the proliferation of fibroblasts inside the body and maintain the strength and shape over a long period of time, which is necessary for healing.

以下、その構成について、例示する。The configuration will be illustrated below.

（構成例）３デニールのポリ−Ｌ一乳酸糸（分子量８００００１０
　３ｇをからめてスライバー状とし、これを縦、横、深
さが夫々６Ｘ２Ｘ２ｃｍの容器に入れ、これに豚由来の
アテロコラーゲン０．３％塩酸溶液５０ｇを１８００ｒ
ｐｍにて６０分間撹拌して注いだ。次いで、これを４８
時間凍結乾燥し、アルコールにて滅菌して本発明充填材
を構成した。(Configuration example) 3 denier poly-L monolactic acid thread (molecular weight 8000010
3 g was mixed to form a sliver, and this was placed in a container measuring 6 x 2 x 2 cm in length, width, and depth, and 50 g of a 0.3% hydrochloric acid solution of pig-derived atelocollagen was added to it at 1800 r.
Stir and pour at pm for 60 minutes. Next, convert this to 48
The filler material of the present invention was prepared by freeze-drying the product and sterilizing it with alcohol.

このようにして得た充填材は、ミクロポーラスなスポン
ジ構造の間にポリ−Ｌ一乳酸糸がランダムに埋入されて
複合化された外観を呈した。The filler thus obtained had a composite appearance in which poly-L monolactic acid threads were randomly embedded between the microporous sponge structure.

また、その物性値は第ｌ表に示すように従来のコラーゲ
ン単独のスポンジと比較し、破断強度、破断伸度、ヤン
グ率が格段に高い値を示し、著しい改善が成された。ま
た、ＰｏｒｅＳｉｚｅも大きくなっている。Furthermore, as shown in Table 1, the physical properties of the sponge were significantly improved in terms of breaking strength, breaking elongation, and Young's modulus, which were significantly higher than conventional sponges made of collagen alone. Moreover, PoreSize is also large.

尚、表における比較例は架橋剤としてグルタールアルデ
ヒトを使用した豚由来のアテロコラーゲン０．２％塩酸
溶液５０ｇを前記と同様の方法によって処理して得たコ
ラーゲン単独のスポンジである。The comparative example in the table is a collagen-only sponge obtained by treating 50 g of a 0.2% hydrochloric acid solution of pig-derived atelocollagen using glutaraldehyde as a crosslinking agent in the same manner as described above.

第１表尚、これの測定はＪＩＳ法に準じた。また、その単位は
以下の通りである。Table 1 Note that this measurement was conducted in accordance with the JIS method. In addition, the units are as follows.

強度：破断強度（Ｘｌｏ’　ｌ　．　［ｄｙｎｅ／ｃｍ
２１伸度：破断伸度（％）ヤング率：　　（　Ｘ　１０’　ｌ　．　　（ｄｙｎｅ
／ｃｌＩ１２１ＰｏｒｅＳｉｚｅ　：　（μｌＩ１）上記の方法により得た本発明充填材を以下の方法により
動物実験に供し、組織学的検討と拘縮の状態を観察した
。Strength: Breaking strength (Xlo' l. [dyne/cm
21 Elongation: Elongation at break (%) Young's modulus: (X 10' l. (dyne
/clI121PoreSize: (μlI1) The filling material of the present invention obtained by the above method was subjected to animal experiments according to the following method, and histological examination and the state of contracture were observed.

（適用例）体重３５０ｇのウィスター系ラットの背部筋層上を２Ｘ
２ｃｍ大に剥離し、その部分に約２ｃｍ３大の本発明充
填材を埋植し、経過を観察した。(Application example) 2X on the back muscle layer of a Wistar rat weighing 350g
It was peeled off to a size of 2 cm, and a filler of the present invention of about 2 cm and 3 sizes was implanted in that part, and the progress was observed.

〈ｌケ月後〉スポンジ内周部分で線維芽細胞の侵入が認められるが中
央部では細胞未侵入。<1 month later> Invasion of fibroblasts is observed in the inner circumference of the sponge, but no cells have invaded in the central area.

〈３ケ月後〉スポンジ中央部への細胞侵入は２ケ月後に比べて増加し
ている。<3 months later> Cell invasion into the center of the sponge increased compared to 2 months later.

く６ケ月後〉スポンジ中央部へ線維芽細胞が一定の方向で並ぶ部分が
できた。6 months later> A region was formed in the center of the sponge where fibroblasts were lined up in a fixed direction.

組織学的検討において埋植３〜４ケ月後にスポンシの中
央部まで線維芽細胞が十分に侵入し、６ケ月後において
は完全に組織が構築された。Histological examination showed that fibroblasts had sufficiently invaded the center of the sponge 3 to 4 months after implantation, and a complete tissue was established 6 months later.

方、拘縮の状態については石膏模型により、その容積を
測定する方法によって行なったが、上記比較例によるも
のは２ケ月後で初期体積の５〜１５％しか残存せず、４
ケ月後では殆ど生体内に吸収され、消失するという結果
であったが、本発明充填材によると６ケｎ後においても
初期体積の３５〜５０％が残存し、かかる面においても
顕著な差が見られた。On the other hand, the state of contracture was measured by measuring the volume using a plaster model, but in the case of the above comparative example, only 5 to 15% of the initial volume remained after 2 months.
The results showed that most of the filler was absorbed into the body and disappeared after 6 months, but with the present filling material, 35-50% of the initial volume remained even after 6 months, and there was a significant difference in this aspect as well. It was seen.

（発明の効果）以上のように本発明による充填材は、その実用結果から
も明らかなように、用途上の要求特付である、組織反足
、かないこと５線雑芽細胞の増殖を促ずこと、絹織が再
生１−るまで長１リｊにわたってその強度、形状が維持
されること、紹織の拘縮を防止ずる機能を有すこと、組
織の再生後は体内に分解吸収されて消失してしまうこと
等、この種の用途に必要な機能を全て兼ね嘲えたもので
あり、効果的な適用が可能なものである。(Effects of the Invention) As described above, the filling material according to the present invention promotes the proliferation of 5-line miscellaneous blast cells, which is a special requirement for its use, as is clear from its practical results. The main reason for this is that the strength and shape of the silk fabric is maintained over a long period of time until it is regenerated, that it has the function of preventing contracture of the silk fabric, and that it is decomposed and absorbed into the body after the tissue is regenerated. It has all the functions necessary for this type of use, such as the fact that it disappears when it disappears, and can be effectively applied.

尚、コラーゲンスボンジと生体分解吸収性高分子材料と
の複合化比率、およびポリ−Ｌ一乳酸繊維の繊度等はそ
の用途、必要機能等に応じて任意に選択可能なものであ
る。The composite ratio of the collagen sponge and the biodegradable and absorbable polymer material, the fineness of the poly-L-lactic acid fibers, etc. can be arbitrarily selected depending on the use, required functions, etc.

以」二のように本発明は、従来にない新規な構成の生体
組織用充填材を提供したものである。As described above, the present invention provides a filling material for living tissue with a novel configuration not seen before.

Claims (1)

Translated fromJapanese

【特許請求の範囲】１、コラーゲンスポンジと生体分解吸収性高分子材料と
の複合材料より成ることを特徴とする生体組織用充填材
。２、繊維状の生体分解吸収性高分子材料がコラコラーゲ
ンスポンジ中に混在し、もしくは埋入されて成ることを
特徴とする請求項（１）項記載の生体組織用充填材。３、生体分解吸収性高分子材料がポリ−Ｌ−乳酸である
ことを特徴とする請求項（１）、（２）項記載の生体組
織用充填材。[Scope of Claims] 1. A filler for living tissue, characterized by being made of a composite material of a collagen sponge and a biodegradable and absorbable polymer material. 2. The filling material for biological tissue according to claim (1), characterized in that a fibrous biodegradable and absorbable polymeric material is mixed or embedded in the collagen sponge. 3. The filler for living tissue according to claims (1) and (2), wherein the biodegradable and absorbable polymeric material is poly-L-lactic acid.