JP7490728B2 - 使い捨ての酸素低減キット、器具及びそれらの使用方法 - Google Patents
使い捨ての酸素低減キット、器具及びそれらの使用方法 Download PDFInfo
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- JP7490728B2 JP7490728B2 JP2022157352A JP2022157352A JP7490728B2 JP 7490728 B2 JP7490728 B2 JP 7490728B2 JP 2022157352 A JP2022157352 A JP 2022157352A JP 2022157352 A JP2022157352 A JP 2022157352A JP 7490728 B2 JP7490728 B2 JP 7490728B2
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Description
本願は、2015年3月10日に出願された米国特許仮出願第62/131,130号に基づく利益を主張し、参照により、本明細書に援用される。
表2:フルオロポリマーの透過性(厚さ100μm、23℃)
一態様では、折り畳み可能な血液容器102は、寸法に応じて、並列されているかまたは末端と末端が接するように配置されている2つのチャンバーを有することができる。別の態様では、折り畳み可能な血液容器102は、寸法に応じて、並列されているかまたは末端と末端が接するように配置されている3つのチャンバーを有することができる。さらに別の態様では、折り畳み可能な血液容器102は、寸法に応じて、並列されているかまたは末端と末端が接するように配置されている3つのチャンバーを有することができる。当業者であれば、空間の利用が最大になるように、隣接した位置と向きで配置された多数のチャンバーを有する追加的な構成の折り畳み可能な血液容器102を作製できるであろう。
一対のRollPrint Clearfoil(登録商標)Zフィルム#37-1275(イリノイ州アディソンのRollprint Packaging Products,Inc.)シート約23×30.5cm(9×12インチ)をヒートシーラーに、短い方の23cmの長さに沿って配置することによって、1つの縁沿いをヒートシールすることで、バリアバッグを作製する。ポリエチレン外層と、PVC内層と、EVAの中間接合層を有するとともに、内径が0.4cm、外径が0.55cmで、長さが約2.6cmである多層チューブ(マサチューセッツ州アソルのPexco,Inc.またはニューハンプシャー州ポーツマスのExtrusion Alternatives,Inc.)を1本、直径約0.4cm、長さ約2.5cmの固体真ちゅうマンドレルに入れてから、上記のフィルムの間に入れて、約130℃に加熱したヒートシールダイの横溝に配置した。プレスを作動させ、21×104パスカル(Pa)で約4秒の長さに設定して、上記の短い多層チューブを適切な位置にシールした状態で、ダイの長さに沿って連続的な溶着シールを作る。この短い多層チューブによって、そのチューブの外径にわたって、酸素不透過性のシールをもたらすと同時に、そのシールを介して流体連通性ももたらす。シクロヘキサノンを用いて、内径が0.3cm、外径が0.41cm、長さが約30.5cmのPVCチューブ(マサチューセッツ州アソルのPexco,Inc.またはニューハンプシャー州ポーツマスのExtrusion Alternatives,Inc.)を1本、バッグの外側から多層チューブに溶剤接合する。
液体シリコーンゴム(LSR)
キシレンなどの好適な溶媒に分散した2液型シリコーンエラストマー分散液(例えば、NuSil MED10-6640)を等量混合することによって、厚みが約25μmのシリコーンシートを作製する。MED10-6640は、2液型樹脂系として供給されている。第1の工程として、液Aと液Bを等しい測定量で混合して、分散液を作る。次に、空気を真空下で除去した。真空時間は、分散液中に気泡が残らないように選択した。次に、この分散液を広げて、特注のナイフコーティングトレイ上で、精密なナイフエッジの下に通した。加熱によって、そのシートを部分的に硬化させてから、その部分的に硬化したシリコーンシートの上に、ポリエステルメッシュファブリックのシート(ブルックフィールドのSurgical Mesh,Inc.、CT#PETKM3002)を置く。このラミネート体の上に負荷をかけることによって、部分的に硬化したシートに、ポリエステルメッシュファブリックを押し込む。周囲温度及び周囲湿度で30分、75℃(167°F)で45分、そして、150℃(302°F)で135分という時間及び温度を組み合わせた順序を用いた段階的硬化を用いて、このラミネート体を硬化して、厚さが約25μmであり、一体化スペーサー110を有するシリコーン膜113を得る(一体化スペーサー110の厚みは、得られたシリコーン膜には含まれない)。ポリエステルメッシュファブリックは、硬化済みシリコーン膜113に接着されているが、シリコーン膜113に完全には封入されていない。膜113の表面の1つは、血液または血液製品と接するのに適するマット仕上げを有する。
Smooth On Sil-Poxy RTV接着剤(ペンシルベニア州イーストンのSmooth-On,Inc.)によって、一対のシリコーンシートの縁を合わせて接合し、その接合したシートを一対のアルミニウム平板の間に置き、シリコーン血液バッグを得ることによって、一対のシリコーンシートからシリコーン血液バッグを作製する。流体通路を設けるために、シリコーン製注入チューブ(McMaster Carr #5236K83、ニュージャージー州ロビンズビルのMcMaster Carr,Inc.)をシームの中に接合して、アルミニウム板の溝の中に入れてから、アルミニウム板を大きいバインダークランプで合わせて固定し、接着剤を一晩硬化させる。翌日、シリコーン血液バッグをアルミニウム板から外し、使用前に、圧縮空気を吹き入れ、水中に入れて、気泡がないか観察することによって、漏れ試験を行う。続いて、実施例1に記載されているようにして作製した外側バリアバッグに、そのシリコーン血液バッグを入れる。
全血及び血液製品は、白血球が低減された全血と、白血球が低減された濃厚赤血球を含め、当該技術分野において知られている技法を用いて調製する。示されているように、Radiometer ABL-90という血液分析装置(カリフォルニア州ブレアのRadiometer America)をメーカーの指示に従って用いて、pH、血液ガス、電解質、代謝物、酸素飽和度測定、ベースラインsO2及びpO2レベルを含め、サンプルを解析する。Hemocue(登録商標)Plasma Low Hb Photometerをメーカーの指示に従って用いて、遊離ヘモグロビンを測定する。
実施例2の酸素枯渇器具に血液を入れて、下記のように試験する。全血(124グラム)を得て、数ccの純酸素ガスを注入することによって酸素で飽和し、Terumo Sterile Connection Device(SCD)を用いて無菌移動することによって、実施例2のシリコーン血液バッグに入れ、移動中、バッグを秤量する。Mocon OpTech Platinumという酸素分析器を用いて、外側容器101のヘッドスペースの酸素レベルを測定し、実験開始時において1.60トールであることが分かる。血液の初期サンプルを取り、Radiometer ABL-90という血液分析装置(カリフォルニア州ブレアのRadiometer America)で測定し、飽和酸素度(sO2)が98.7%であることが分かる。血液の入ったバリアバッグを作業机の上に室温(21.0℃)で置き、1時間、振盪せずに静置する。1時間後、sO2は、93.5%のsO2であり、バリアバッグのヘッドスペースの酸素は、0.70トールの酸素であることが分かる。血液の入ったバリアバッグを室温(21.0℃)で約14時間、振盪せずにインキュベートする。14時間のインキュベート後、sO2は、66.7%であることが分かり、さらに7時間、21℃で振盪せずにインキュベートした後のsO2の最終的な測定値は、51.2%である。脱酸素化速度は、一次速度式に従っており、速度定数を算出したところ、約min-1程度である。
水蒸気透過性速度が1800gr/m2/24時間と報告されている通気性ポリウレタンフィルム(コネチカット州ブランフォードのAmerican Polyfilm)から、折り畳み可能な血液バッグを作製し、一対のフィルムを合わせて溶着して形状を作り出すための特注のヒートシールダイを用いて、蛇行流路を作製する。蛇行路を備える折り畳み可能なバッグは、幅約5mm、長さ220mmの12本の一連の流路で構成させ、約2640mmの全体流路をもたらす。実施例1に従って、折り畳み可能なバッグを外側バリア内にシールする。得られた枯渇器具は、本開示ですでに説明したように、末端の1つの中にシールした2本の多層チューブをさらに備え、蛇行路の注入口・排排出口が、その多層チューブの部品と流体連通するようになっている。
これらの結果により、調査の間、上記のシステムは、血液の明らかな脱酸素化を行わないが、酸素を透過性の標準的なPVC血液バッグから吸収することが示されている。このことから、注入口、排出口、ポート及びチューブで酸素が侵入するのを防ぐために、追加の測定値を取ることの重要性が示されている。
表3:ウレタンバッグを用いた脱酸素化
*ヘッドの高さが914mm。他のすべての流入動作は、高さが457mm。
下記の表4に従って、一連の折り畳み可能な内側の血液容器102を作製し、実施例1に示されているような外側容器101内にシールする。白血球が低減された濃厚赤血球(LRpRBC)を容器102に入れる。得られた酸素枯渇器具10は、Mocon Optech-O2センサーをさらに備えていた。表4に従って、組み立てた血液容器をHelmer Labs Platelet Shaker,Model PF96の上に置き、血液及びヘッドスペースのサンプルを得て、0~300分の時点に解析する。
表4:折り畳み可能な内側の血液容器102の試験構成
それぞれ152μmの厚さと228μmの厚さの一対のシリコーンシート(McMaster Carr #87315K71、ニュージャージー州ロビンズビルのMcMaster Carr,Inc.)を、周縁で合わせて、Sil-Poxyというシリコーン接着剤(ペンシルベニア州イーストンのSmooth-On,Inc.)で接合して、流体連通のために、注入チューブとしてシリコーンチューブ(McMaster Carr #9628T42、ニュージャージー州ロビンズビルのMcMaster Carr,Inc.)を接合したものから、折り畳み可能な血液容器102を作製する。接合したシートを2日間、クランプしたアルミニウム板の間で硬化させる。
表6:30.5×30.5cmのシリコーンバッグを用いた脱酸素化
算出した脱酸素化速度定数は、-0.34×10-2min-1である。
折り畳み可能な内側のシリコーン製血液容器102を有する4つの酸素低減バッグ(ORB)を実施例3に従って作製する。体積に対する表面積(SAV)の比率が約6cm2/mlになるように、折り畳み可能な内側の血液容器102に、白血球が低減された濃厚赤血球(LRPRBC)であって、実施例4に従って調製したLRPRBCを充填する。
LRPRBCを充填した3つのORBをHelmer PF-96 Platelet Agitator(インディアナ州、ノーブルビル)または振盪器のPF-8の上に平らに置き、1分当たり標準的なサイクル(72cpm)または修正して標準的なcpmよりも低下させたcpm(42cpm)で線形振動させる。3セット目の充填済みORBを振盪器のBenchmark 3D 5RVH6(ニュージャージー州セアビル)に設置する。サンプルを回収し、0分、60分、120分及び180分の時点に、実施例4に概説されているような様々なABL-90出力値について解析する。
別の例では、折り畳み可能な内側の血液容器102を有する6つの酸素低減バッグ(ORB)をBentecのシリコーンで作製する。LRPRBCを採取し、実施例4に従って作製する。折り畳み可能な内側のシリコーン製血液容器102に、LRPRBCを176mL、220mL、250mL、270mL、300mL及び350mL充填して、表7に示されているように、体積に対する表面の比率を3.41~6.8cm2/mlにする。様々な体積のLRPRBCを含むORBにおいて、0分、30分、60分、120分及び180分の時点に、実施例4に記載されているように、sO2の値を測定する。
表7:体積に対する表面積の比率
ヒートシールした折り畳み可能な酸素透過性ポリスルホン及びPVDF製血液容器102を作製する。シールの作製により、フィルムの微多孔質構造が壊れ、得られた容器102内での流体の移動に伴う曲げ応力の影響を受けやすい結晶区域が生じる。容器102は、漏れたり破れたりしやすく、実験設定外での使用が意図されているORBには適さない。
折り畳み可能な内側の血液バッグと酸素枯渇器具は、本開示によるスペーサー110を備えるかまたは備えない状態で、上記の実施例に従うものである。図16に示されているように、スペーサー110を組み込むと、酸素枯渇速度が有意に上昇する。
Claims (20)
- 血液から酸素を枯渇させ、かつ酸素を枯渇させた血液を保存するための、酸素低減保存システムであって、前記システムが、
-血液から酸素を枯渇させるための酸素枯渇構成要素と、
-酸素を枯渇させた血液を保存するための嫌気性血液保存構成要素と、
を含み、
前記酸素枯渇構成要素が、
・酸素不透過性である第1の外側容器と、
・酸素透過性である1以上のチャンバーを備える、第1の折り畳み可能な内側の血液容器と、
・少なくとも1つの注入口/排出口を有する第1のセットであって、少なくとも1つの注入口/排出口を有する前記第1のセットの各注入口/排出口が、前記第1の外側容器を貫通しており、かつ前記第1の折り畳み可能な内側の血液容器に連結している第1のチューブを含み、第1の接合部が、前記少なくとも1つの注入口/排出口を有する第1のセットを前記第1の外側容器へ接合し、及び前記第1の外側容器への前記第1の接合部が酸素不透過性である、前記第1のセットと、
・第1の酸素吸収剤と、
・前記第1の外側容器と前記第1の折り畳み可能な内側の血液容器との間に置かれた第1のメッシュスペーサーであって、前記第1のメッシュスペーサーが少なくとも1つの第1の開口区域を含み、かつ、前記第1の外側容器と前記第1の折り畳み可能な内側の血液容器とにより画定される第1のヘッドスペースを維持し、前記少なくとも1つの第1の開口区域が、前記第1のメッシュスペーサーのメッシュ材料の総面積の50~80%を占め、前記第1のヘッドスペースが10~500ミリリットル(mL)の容積を有し、前記第1の酸素吸収剤が前記第1のヘッドスペース内に設置されており、前記第1のヘッドスペースにより、前記第1の折り畳み可能な内側の血液容器の表面から、前記第1の酸素吸収剤への酸素の効率的拡散を確保する、前記スペーサーと、
を備え、
前記嫌気性血液保存構成要素が、
・酸素不透過性である第2の外側容器と、
・第2の折り畳み可能な内側の血液容器と、
・少なくとも1つの注入口/排出口を有する第2のセットであって、少なくとも1つの注入口/排出口を有する前記第2のセットの各注入口/排出口が、前記第2の外側容器を貫通しており、かつ前記第2の折り畳み可能な内側の血液容器に連結している第2のチューブを含み、第2の接合部が、前記少なくとも1つの注入口/排出口を有する第2のセットを前記第2の外側容器へ接合し、及び前記第2の外側容器への前記第2の接合部が酸素不透過性である、前記第2のセットと、
・第2の酸素吸収剤と、
・前記第2の外側容器と前記第2の折り畳み可能な内側の血液容器との間に置かれた第2のメッシュスペーサーであって、前記第2のメッシュスペーサーが少なくとも1つの第2の開口区域を含み、かつ前記第2の外側容器と前記第2の折り畳み可能な内側の血液容器とにより画定される第2のヘッドスペースを維持し、前記少なくとも1つの第2の開口区域が、前記第2のメッシュスペーサーのメッシュ材料の総面積の50~80%を占め、前記第2のヘッドスペースが10~500ミリリットル(mL)の容積を有し、前記第2の酸素吸収剤が前記第2のヘッドスペース内に設置されており、前記第2のヘッドスペースにより、前記第2の折り畳み可能な内側の血液容器の表面から、前記第2の酸素吸収剤への酸素の効率的拡散を確保する、前記スペーサーと、
を備える、前記システム。 - さらに、静脈針と、抗凝固液を含む採血バッグとを備える、請求項1に記載の酸素低減保存システム。
- さらに、前記静脈針を前記採血バッグに連結し、前記採血バッグを前記酸素枯渇構成要素に連結し、前記酸素枯渇構成要素を前記嫌気性血液保存構成要素に連結するのに十分なチューブを備える、請求項2に記載の酸素低減保存システム。
- 使い捨てである、請求項1~3のいずれか1項記載の酸素低減保存システム。
- さらに、酸素インジケーターを備え、前記酸素インジケーターが存在する酸素の量の表示を提供する、請求項1に記載の酸素低減保存システム。
- 前記嫌気性血液保存構成要素がさらに酸素インジケーターを備え、前記酸素インジケーターが存在する酸素の量の表示を提供する、請求項1に記載の酸素低減保存システム。
- 前記第1のチューブが、酸素不透過性の多層チューブであるか、前記第2のチューブが酸素不透過性の多層チューブであるか、前記第1のチューブが、酸素不透過性の多層チューブであり、かつ、前記第2のチューブが酸素不透過性の多層チューブである、請求項1に記載の酸素低減保存システム。
- 前記第2の外側容器の形状内で、前記第2の折り畳み可能な内側の血液容器の位置を調節するように適合された位置決め機構をさらに備え、前記位置決め機構が、幾何学的な切除部、触知的な表面マーク、ダイカット基準マーク、スペーサー、嵌合型切除部及び印刷マークからなる群から選択される、請求項1に記載の酸素低減保存システム。
- 前記第1の酸素吸収剤は、標準温度及び圧力において、少なくとも100立方センチメートル(c.c.)の酸素結合能を有し;及び
前記第2の酸素吸収剤は、標準的な温度及び圧力において、少なくとも60立方センチメートルの酸素結合能を有する、請求項1に記載の酸素低減保存システム。 - 前記第1の酸素吸収剤が、さらに二酸化炭素吸収剤を含む、請求項1に記載の酸素低減保存システム。
- 前記第1の酸素吸収剤が、前記第1のヘッドスペース内に配置された小袋内に位置する、請求項1に記載の酸素低減保存システム。
- 前記第2の酸素吸収剤が、さらに二酸化炭素吸収剤を含む、請求項1に記載の酸素低減保存システム。
- 前記第2の酸素吸収剤が、前記第2のヘッドスペース内に配置された小袋内に配置されている、請求項1に記載の酸素低減保存システム。
- 前記第1及び第2の折り畳み可能な内側の血液容器の各々が、ポリビニリデンジフルオライド(PVDF)微多孔質膜、ポリスルホン微多孔質膜、ポリオレフィン微多孔質膜、及びポリテトラフルオロエチレン(PTFE)微多孔質膜からなる群から選択される微多孔質膜を備える、請求項1に記載の酸素低減保存システム。
- 前記折り畳み可能な内側の血液容器内の前記酸素枯渇血液が、最大64日間の保存期間中、15ミリメートル水銀柱(mmHg)未満の酸素分圧(PO2)を維持する、請求項1に記載の酸素低減保存システム。
- 前記第1及び第2のヘッドスペースの各々が、20~400ミリリットル(mL)の容積を有する、請求項1に記載の酸素低減保存システム。
- 前記少なくとも1つの第1の開口区域が、前記第1のメッシュスペーサーの前記メッシュ材料の総面積の60%~75%を構成する、請求項1に記載の酸素低減保存システム。
- 前記少なくとも一つの第2の開口区域が、前記第2のメッシュスペーサーの前記メッシュ材料の総面積の60%~75%を構成する、請求項1に記載の酸素低減保存システム。
- 前記少なくとも1つの第1の開口区域が、0.75平方ミリメートル(mm2)より大きい全開口区域面積を有する、請求項1に記載の酸素低減保存システム。
- 前記少なくとも1つの第2の開口区域は、0.75平方ミリメートル(mm2)より大きい全開口区域面積を有する、請求項1に記載の酸素低減保存システム。
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