JP2006043468A - 石灰化を軽減するための生物学的組織の処理方法 - Google Patents
石灰化を軽減するための生物学的組織の処理方法 Download PDFInfo
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Abstract
【解決手段】 この方法は、生物学的組織を処理溶液に接触させて配置する工程、相対的な組織/溶液運動を起こす工程、および処理溶液を加熱する工程を包含する。この相対的運動を起こすには、組織が処理溶液に浸漬されている容器を振とうするか、または容器内の溶液を攪拌する。この運動を起こすにはまた、処理溶液を、処理する組織を通して流しても良い。組織は処理容器内で自由に動き得、または大きく動かないようにされ得る。流れはレザバを有する循環システムの一部であり得、ヒーターが設けられており、これによってレザバ内の処理溶液を加熱する。
【選択図】 図1
Description
a)患者の年齢
b)現存する代謝障害
(すなわち、カルシウム過剰血症、糖尿病、腎不全)
c)食事因子
d)人種
e)感染
f)非経口カルシウム投与
g)脱水
h)歪曲/機械的因子
i)外科移植後の初期期間の不適当な凝固療法;および
j)宿主組織化学
哺乳動物身体内への移植後の組織の石灰化を阻害するための、固定された生物学的組織の処理方法は、哺乳動物身体内への移植後のこのような組織の使用可能な寿命を実質的に増加させる傾向があり、それ故、次の組織の取換えの必要性を軽減させる。当業者が理解するように、このような組織の取換えは、しばしば患者に実質的な外傷を引き起こし、時には、患者の死を招く。このように、移植された生物学的組織の取換えの必要性を避けるかまたは延期することのいずれかが可能なことは、大いに有益である。
本発明の他の利点と同様にこれらは、以下の記載および図面からより明白にされる。示され、かつ記載された特定の構造の変化は、本発明の精神から逸脱することなく本請求項の範囲内でなされ得ることが理解される。
添付した図に関連して下記に示される詳細な説明は、本発明の現在好ましい実施態様の説明として意図され、そして本発明が構築され得るかあるいは利用され得る唯一の形態を表すことは意図されない。この説明は、図示された実施態様に関連して、本発明を構築または実行するための工程の機能および順序を示す。しかし、本発明の精神および範囲内に含まれることも意図される異なる実施態様によって、同様または同等の機能および順序が成し遂げられ得ることが、理解されるべきである。
(熱を用いた組織処理)
ここで、図2について言及すれば、哺乳動物身体内への移植後の生物学的組織の石灰化を阻害するための、グルタルアルデヒド固定化生物学的組織の処理のための方法は、好ましくはグルタルアルデヒドが生物学的組織と接触している時、約4〜22週間、より好ましくは22週間以内の数日間、約35〜75℃に加熱するさらなる工程を含む。
(相対的組織/流体運動を用いた組織処理)
図3は、本発明の組織処理システム20の好ましい実施態様を図示する。1片あるいはそれ以上の組織22あるいはリーフレットが、閉じた容器25内の処理溶液24に浸漬される。容器25は振とうテーブル26上にあり、これはベース27に対して1方向あるいはそれ以上に、往復運動する。1つの特に好ましいタイプの振とう装置は、オービタルシェイカー(orbitalshaker)である。1つの例示の実施態様において、オービタルシェイカー26はほぼ55 RPMの回転速度で作動される。容器25およびその内容物は、図示するような放射ヒーター28のようなもので加熱される。もちろん、容器25を加熱するためのたくさんの方法が公知であり、例えば抵抗ヒーター、対流などである。
(相対的組織/流体流れを用いた組織処理)
図6は、処理システム40の他の変形を概略的に示し、これは、容器の振とうまたは組織が入っている流体の撹拌に対して、組織を通過する流れを利用する。この流れが処理溶液と組織との間に相対的運動を生じさせ、これが、有利な石灰化軽減効果をもたらすと信じられている。
(フローカラム装置)
図8はフローカラム60の斜視図であり、これは図6に概略的に示したフロー容器42の置換物であり得る。カラム60は好ましくは透明なアクリルチューブ61であり、内径約6インチ(15.2cm)、高さ約6フィート(1.8 m)、および容積約10ガロン(38 l)である。シリンダー60の上端および下端はそれぞれキャップ62aおよび62bで閉じられ、これらはO-リング(図示せず)によりシリンダー60の内表面に密着されている。キャップ62bの中央にある下方入り口取付具64は導管を提供し、これによって処理溶液をシリンダー60の下端に導入する。同様に、キャップ62aに接続された上方取付具66は、処理溶液用の出口を提供する。ある長さのホース68によって下方取付具64がポンプ70に接続され、これが次にホース72によって流体レザバ74に接続される。循環処理システムがある長さのホース76によって完成され、これは上方固定具66をレザバ74に接続する。流体連結および必要条件を当業者は理解し、これらは本明細書ではさらに述べない。
straightener)92が減速板(velocity reducer plate)94の真上に配置される。したがって開口90を通る入り口流れは、減速板94および整流装置92を通って上方に通過し、最下バッフル82に衝突する。減速板94は円盤状プレートであり、複数の開口96がそれに形成されている。これらの開口は板94上で比較的広く間隔を開けられており、流れをドラッグしてその速度を遅くする。整流装置92はハニカム構造に似ており、比較的密集した多数の別個のフローチャネルを有し、垂直寸法が減速板94やバッフル82より大きい。流れが開口90を通ってカラム60に入り、上方に流れ続けて減速板94および整流装置92を通過する。流れが整流装置92を通過した後で、最下バッフル82に衝突する。処理溶液は上方に流れて個々のバッフル82を通過し、個々の相次ぐセクション80に入り、カラム60の頂上に出る。カラム60は初め空気で満たされているが、上昇する処理溶液の流れがカラムを通って上方に通過するに連れて、外に押し出される。
(ラット皮下試験)
図12および13は、様々な方法で処理し、ラットに数ヶ月間皮下移植し、取り出した組織から測定したカルシウム捕捉の結果である。これらのグラフは、熱処理のみのものはコントロールと比べてカルシウム捕捉が減少すること、および熱および運動で処理したものはさらにカルシウム捕捉が減少することを示す。多数の振とう、撹拌または運動装置を2つの異なる温度で用い、同様な、一般的な結果が得られた。
24 処理溶液
25 容器25
30 組織処理システム20
40 組織処理システム20
Claims (16)
- 哺乳動物身体内への移植後の生物学的組織の石灰化を阻害するために、少なくとも部分的に固定された生物学的組織を処理する方法であって、以下の工程:
該組織をフロー容器内に置く工程;
該組織が該容器内で大きく動かないようにする工程;
処理溶液を該フロー容器を通じて流し、該組織と接触させる工程;および
該流す工程中、該溶液を加熱する工程、
を包含する方法。 - 前記動かないようにする工程が、前記組織を平坦な配置で、前記流れる溶液の流れ方向に対して実質的に平行に設ける工程を包含する、請求項1に記載の方法。
- 前記流れる溶液の流れ方向に対して実質的に垂直に配向する断面を有するフロー容器内に前記組織を配置し、バッフルの下流に位置する組織が、その断面に亘って実質的に均一な下流の流れのプロファイルを作る、請求項1に記載の方法。
- 処理溶液を前記フロー容器の入り口へ、レザバから供給し、流体を該フロー容器の出口から、該レザバへと排出する工程をさらに包含する、請求項1に記載の方法。
- 前記レザバ内の前記処理溶液を加熱する工程をさらに包含する、請求項4に記載の方法。
- 前記フロー容器を、ミシン目の付いたバッフルによって一連のセクションに分割し、複数の組織を個々のセクションに配置する工程をさらに包含する、請求項1に記載の方法。
- 前記フロー容器内に入り口および出口をさらに有し、前記方法が、処理流体を該フロー容器を通じて該入り口から該出口へと流し、前記組織と接触させる工程を包含する、請求項1に記載の方法。
- 哺乳動物身体内への移植後の生物学的組織の石灰化を阻害するために、少なくとも部分的に固定された生物学的組織を処理する装置であって、以下:
フロー容器;
処理溶液の供給源;
該容器への流体インプット;
該容器からの流体アウトプット;
少なくとも部分的に固定した生物学的組織を該容器内の該インプットおよびアウトプットの間の配置し、該組織がその中で大きく動かないようにするための、組織マウント;および
該流体を加熱する手段、
を有する、装置。 - 前記フロー容器が、ミシン目の付いたバッフルによって分離された、少なくとも2つの一連のセクションを有し、個々のセクション内に少なくとも1つの組織マウントがある、請求項8に記載の装置。
- 前記フロー容器が長いチューブであって、前記バッフルが円形である、請求項9に記載の装置。
- 前記組織マウントが、前記組織を平坦な配置で、前記容器を通じて流れる前記溶液の流れ方向に対して実質的に平行に設けるように配置されている、請求項8に記載の装置。
- 前記フロー容器内の、前記組織マウントの上流に配置された少なくとも1つのバッフルをさらに有し、該バッフルが、実質的に均一な下向きの流れを作り、該フロー容器の断面の輪郭を作るように配置されている、請求項8に記載の装置。
- 前記バッフルがミシン目の付いたプレートであり、前記容器を通じて流れる前記溶液の流れ方向に対して実質的に垂直に配向しており、前記フロー容器が、少なくとも2つの一連のセクションに分割されており、それぞれ2つの隣接するセクションがバッフルによって分離されており、少なくとも1つの組織マウントが個々のセクション内で、該バッフルの1つに取り外し可能に固定されている、請求項12に記載の装置。
- 前記流体の供給源がレザバを有し、前記流体を加熱する前記手段が、該レザバ内の流体を加熱するためのヒーターを有する、請求項8に記載の装置。
- 前記レザバ内の前記流体の温度をモニターするためのセンサー、および感知した温度に応答性であり、該ヒーターの温度を調節するための、フィードバック制御ループをさらに有する、請求項14に記載の装置。
- 前記フロー容器が直立したチューブを有し、前記入り口の開口が該チューブの下端にあり、前記出口の開口が該チューブの上端にあり、前記装置が、該入り口の開口の上に減速装置を、および該減速装置の上であって前記第一組織マウントの下に整流装置を、さらに有する、請求項8に記載の装置。
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- 1998-05-18 AU AU75748/98A patent/AU7574898A/en not_active Abandoned
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- 1998-05-18 BR BR9810252-4A patent/BR9810252A/pt not_active Application Discontinuation
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- 1998-05-18 JP JP50246799A patent/JP3433949B2/ja not_active Expired - Lifetime
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- 1999-04-10 US US09/283,596 patent/US6210957B1/en not_active Ceased
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WO1996004028A1 (en) * | 1994-07-29 | 1996-02-15 | Baxter International Inc. | Methods for treating implantable biological tissues to mitigate the calcification thereof and bioprosthetic articles treated by such methods |
JP3433949B2 (ja) * | 1997-06-13 | 2003-08-04 | エドワーズ ライフサイエンシーズ コーポレイション | 石灰化を軽減するための生物学的組織の処理方法 |
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JP2000512889A (ja) | 2000-10-03 |
WO1998056432A1 (en) | 1998-12-17 |
CA2293474A1 (en) | 1998-12-17 |
US5931969A (en) | 1999-08-03 |
BR9810252A (pt) | 2000-09-19 |
ATE228376T1 (de) | 2002-12-15 |
JP2004136098A (ja) | 2004-05-13 |
AU7574898A (en) | 1998-12-30 |
US6210957B1 (en) | 2001-04-03 |
EP0988069B1 (en) | 2002-11-27 |
JP5300154B2 (ja) | 2013-09-25 |
DE69809738D1 (de) | 2003-01-09 |
DE69809738T2 (de) | 2003-08-21 |
CA2293474C (en) | 2003-07-29 |
JP3433949B2 (ja) | 2003-08-04 |
JP3764084B2 (ja) | 2006-04-05 |
EP0988069A1 (en) | 2000-03-29 |
JP2002179501A (ja) | 2002-06-26 |
JP2011031054A (ja) | 2011-02-17 |
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