JP2021515679A - 血漿収集量を最適化するためのシステムおよび方法 - Google Patents
血漿収集量を最適化するためのシステムおよび方法 Download PDFInfo
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- JP2021515679A JP2021515679A JP2020557304A JP2020557304A JP2021515679A JP 2021515679 A JP2021515679 A JP 2021515679A JP 2020557304 A JP2020557304 A JP 2020557304A JP 2020557304 A JP2020557304 A JP 2020557304A JP 2021515679 A JP2021515679 A JP 2021515679A
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- donor
- plasma
- volume
- anticoagulant
- collection
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Abstract
Description
RBCの体積=全血の体積×Hct/100。 [1]
原料血漿の体積=全血の体積×(1−Hct/100)。 [2]
抗凝固剤を全血と混合する場合、通常、全血16部とAC1部、または全血1部とAC0.06部のAC比(ACR)で計量される。
ACR=全血の体積/抗凝固剤の体積(抗凝固剤を含まないドナーの血液)。 [3]
(これにより、上記のように、抗凝固剤と抗凝固血液の比率が1:16、または抗凝固剤0.06部と抗凝固血液1部に加えられる抗凝固剤の体積が標準化されているFDAノモグラムとはわずかに異なる結果が得られる。)
抗凝固血液の体積=抗凝固剤の体積+全血の体積。 [4]
方程式を組み合わせると、次のようになる。
原料血漿の体積=ACR×抗凝固剤の体積×(1−Hct/100)。 [5]
赤血球はドナーに戻されるので:
収集された血漿の体積=原料血漿の体積+抗凝固剤の体積。 [6]
式[5]と[6]を組み合わせて、収集された血漿の特定の量に含まれる抗凝固剤の量を計算できる。
抗凝固剤の体積=収集された血漿の体積/(1+ACR×(1−Hct/100))。 [7]
さらに:
収集された血漿の体積=原料血漿の体積×K、ここでK=(ACR×(1−Hct/100)+1)/(ACR×(1−Hct/100))。 [8]
Claims (41)
- 血漿生成物が複数の収集段階で収集され、その間に分離された赤血球がドナーに再注入されるアフェレーシス手順で血漿生成物の目標体積(VPP)を収集する方法であって、ここで、VPPはドナーから収集できる原料血漿の体積(VRP)と、アフェレーシス手順中にVRPに追加される抗凝固剤の体積(VAC)を加えたものに等しく、工程が、
a)ドナーの体重(Wkg)と性別(MまたはF)を決定すること、
b)ドナーのヘマトクリット値(Hct)を決定すること、
c)ドナーの体重(Wkg)とドナーの性別(MまたはF)を使用して収集できる原料血漿の体積(VRP)を決定すること、
d)抗凝固剤比およびドナーのHctに基づいて、K=VPP/VRPとなるように、VPPとVRPとの間の比Kを決定すること、
e)VPP=VRP×KとなるようにVPPを決定すること、
f)ドナーから全血を採取すること、
g)採取した全血に特定の比率(ACR)で抗凝固剤を導入すること、
h)採取した全血を血漿生成物と赤血球を含む第2の成分とに分離すること、
i)血漿生成物を血漿収集容器に収集すること、
j)所望の量の全血がドナーから採取された後、赤血球をドナーに戻すこと、そして、
k)各収集段階の前にドナーのHctと目標VPPを決定すること、
を含む、方法。 - 前記収集容器内の血漿生成物の測定された体積がVPPに等しくなるまで工程c)〜k)を繰り返すことをさらに含む、請求項1に記載の方法。
- K=VPP/VRP=(ACR×(1−Hct/100)+1)/(ACR×(1−HCT/100))である、請求項1または請求項2に記載の方法。
- 第1の収集段階に続く各収集段階の前にドナーのHctを決定する工程は、ドナーに戻される赤血球とともにドナーに戻される抗凝固剤と間質液の移動を計算に入れる工程である、請求項1から請求項3までのいずれか1項に記載の方法。
- ドナーの年齢および身長を決定すること、および、VRPを決定する際にドナーの年齢および身長を使用することをさらに含む、請求項1から請求項4までのいずれか1項に記載の方法。
- 血漿生成物が複数の収集段階で収集され、その間に分離された赤血球がドナーに再注入されるアフェレーシス手順で血漿生成物の目標体積(VPP)を収集する方法であって、ここで、VPPはドナーから収集できる原料血漿の体積(VRP)と、アフェレーシス手順中にVRPに追加される抗凝固剤の体積(VAC)を加えたものに等しく、工程が、
a)ドナーの体重(Wkg)と性別(MまたはF)を決定すること、
b)ドナーのヘマトクリット値(Hct)を決定すること、
c)ドナーの体重(Wkg)とドナーの性別(MまたはF)を使用して収集できる原料血漿の体積(VRP)を決定すること、
d)抗凝固剤比(ACR)およびドナーのHctに基づいて、VAC=VRP×(ACR×(1−Hct))となるように、VRPに追加されるVACを決定すること、
e)VPP=VRP+VACとなるようにVPPを決定すること、
f)ドナーから全血を採取すること、
g)採取した全血に特定の比率(ACR)で抗凝固剤を導入すること、
h)採取した全血を血漿生成物と赤血球を含む第2の成分とに分離すること、
i)血漿生成物を血漿収集容器に収集すること、
j)所望の量の全血がドナーから採取された後、赤血球をドナーに戻すこと、そして、
k)各収集段階の前にドナーのHctとVPPを決定すること、
を含む、方法。 - 前記収集容器内の血漿生成物の測定された体積がVPPに等しくなるまでステップd)〜k)を繰り返すことをさらに含む、請求項6に記載の方法。
- 第1の収集段階に続く各収集段階の前にドナーのHctを決定する工程は、ドナーに戻される赤血球とともにドナーに戻される抗凝固剤と間質液の移動を計算に入れる工程である、請求項6または請求項7に記載の方法。
- ドナーの年齢および身長を決定すること、および、VRPを決定する際にドナーの年齢および身長を使用することをさらに含む、請求項6から請求項8までのいずれか1項に記載の方法。
- VRPは、ドナーの体重の複数の範囲のそれぞれについてのVRPを確立し、ドナーの体重を含む体重の範囲のVRPを選択することによって決定される、請求項1または請求項6に記載の方法。
- ドナーの体重の範囲が、110から149ポンド、150から174ポンド、および175ポンド以上の3つのカテゴリーである、請求項10に記載の方法。
- VRP=K1×Wkgである、請求項1または請求項6に記載の方法。
- VRPがドナーの28.6%(1−Hct)×血液体積(Vb)以下である、請求項1または請求項6に記載の方法。
- Vbは、ナドラーの方程式、ギルチャーの5の法則、およびICSHの基準の1つを使用して決定される、請求項13に記載の方法。
- VRP=Wkg×10mL/kgである、請求項1または請求項6に記載の方法。
- ドナーパラメータは、前記ドナーの総血液体積(Vb)を推定するために使用され、VRP=K2×Vbである、請求項1または請求項6に記載の方法。
- Vbは、ナドラーの方程式、ギルチャーの5つの法則、ICSHの基準、および他の一般的に受け入れられている方法論の1つを使用して決定される、請求項16に記載の方法。
- 再利用可能なハードウェア構成要素と使い捨てキットを含む、全血から血漿を分離するための自動システムであって、
a)前記使い捨てキットはさらに、
i)全血を血漿画分と濃縮細胞画分に分離するための分離器であって、ドナーから分離器に全血を輸送するためにそこに一体的に接続された血液ラインを有する入力、血漿ラインによって血漿収集容器に一体的に接続された血漿出力ポート、およびドナーへの再注入の前に濃縮細胞を受け取るための貯留部に一体的に接続された濃縮細胞出口ポートとを有する分離器と、
ii)全血をドナーから血液ラインに輸送するための静脈穿刺針中で終端するドナーラインと、
iii)血液ラインに一体的に接続され、抗凝固剤をドナーラインに輸送するための抗凝固剤の供給源に接続されるように構成された抗凝固剤ラインと、
iv)生理食塩水を血液ラインに輸送するための生理食塩水源に取り付けられるように構成された生理食塩水ラインと、および、
v)濃縮細胞を貯留部からドナーラインに輸送するための再注入ラインと
を含み、
b)前記再利用可能なハードウェア構成要素はさらに、
i)収集段階で抗凝固剤を制御された速度で血液ラインに送達するための第1の蠕動ポンプと、
ii)収集段階で抗凝固処理された全血を分離器に送り、再注入段階で濃縮細胞成分を戻すための第2のポンプと、
iii)収集段階中に、濃縮細胞成分を分離器から貯留部に送達するための第3のポンプと、
iv)血液ライン、血漿ライン、再注入ライン、生理食塩水ラインのそれぞれに関連付けられたクランプと、
v)血漿収集容器、貯留部、および抗凝固剤の供給源のそれぞれを計量するための重量計、および
vi)操作者からの入力を受信するためのタッチスクリーンを備えたプログラム可能な制御部であって、プログラム可能な制御部は、各重量計から信号を受信し、全血を収集段階で血漿画分と濃縮細胞画分に分離し、再注入段階で濃縮細胞をドナーに戻すため、第1のポンプ、第2のポンプ、第3のポンプとクランプを自動的に操作する制御部と
を含み、そして
c)前記プログラム可能な制御部は、請求項1から請求項17および請求項22から請求項36のいずれか1項に記載の方法に従って血漿収集容器に収集される血漿画分の重量を決定し、血漿収集容器のための重量計から、制御部によって決定された血漿画分の重量に等しい信号を受信すると収集段階を終了するように構成されている、自動化システム。 - 前記分離器は、回転膜分離器を備える、請求項18に記載の自動化システム。
- 前記制御部は、各収集段階の前にドナーのヘマトクリット値を計算するようにさらに構成されている、請求項18または請求項19に記載の自動化システム。
- ドナーのヘマトクリット値を示す信号を前記制御部に送信するセンサをさらに備える、請求項18から請求項20までのいずれか1項に記載の自動化システム。
- 血漿生成物が複数の収集段階で収集され、その間に分離された赤血球がドナーに再注入されるアフェレーシス手順において血漿を収集するための方法であって、
a)ドナーの全血の体積(Vb)およびヘマトクリット値(Hct)を決定すること、
b)Vbに基づいてドナーから収集できる原料血漿の体積(VRP)のを決定すること、
c)収集され得る血漿生成物の目標体積(VPP)を決定し、血漿生成物は原料血漿の体積と抗凝固剤の体積を含むこと、
d)ドナーから全血を採取すること、
e)採取した全血に特定の比率(ACR)で抗凝固剤を導入すること、
f)採取した全血を血漿生成物と赤血球を含む第2の成分とに分離すること、
g)血漿生成物を血漿収集容器に収集すること、
h)所望の量の全血がドナーから採取された後、赤血球をドナーに戻すこと、そして、
i)各収集段階の前にドナーのHctとVPPを決定すること、
を含む、方法。 - 前記収集容器内の血漿生成物の測定された体積がVPPに等しくなるまで工程d)〜i)を継続することをさらに含む、請求項22に記載の方法。
- VPP/VRP=(ACR×(1−Hct/100)+1)/(ACR×(1−HCT/100))である、請求項22または請求項23に記載の方法。
- 第1の収集段階に続く各収集段階の前にドナーのHctを決定する工程は、ドナーに戻される赤血球とともにドナーに戻される抗凝固剤と間質液の移動を計算に入れる工程である、請求項22から請求項24までのいずれか1項に記載の方法。
- Vbは、ドナーの体重、身長、性別、年齢、および形態を含む1つまたは複数のドナー固有の特性に基づいて決定される、請求項22から請求項25までのいずれか1項に記載の方法。
- 血漿を収集する方法であって、
a)ドナーの全血の体積(Vb)およびヘマトクリット値(Hct)を決定すること、
b)Vbに基づいてドナーから収集できる原料血漿の体積(VRP)のを決定すること、
c)VAC=VRP×(ACR×(1−Hct))となるように、抗凝固剤比(ACR)とドナーのHctに基づいて、VRPに追加される抗凝固剤の体積VACを決定すること、
d)収集され得る血漿生成物の体積(VPP)を決定すること、ここで、血漿生成物は、原料血漿の体積(VRP)に抗凝固剤の体積(VAC)を加えたものを含み、
e)ドナーから全血を採取すること、
f)採取した全血に指定された比率(ACR)で抗凝固剤を導入すること、
g)採取した全血を血漿生成物と赤血球を含む第2の成分に分離すること、
h)血漿収集容器に血漿生成物を収集すること、
i)所望の量の全血がドナーから採取された後、赤血球をドナーに戻すこと、および、
j)各収集段階の前にドナーのHctとVPPを決定すること、を含む、方法。 - 前記収集容器内の血漿生成物の測定された体積がVPPに等しくなるまで工程d)〜j)を継続することをさらに含む、請求項24に記載の方法。
- 第1の収集段階に続く各収集段階の前にドナーのHctを決定する工程は、ドナーに戻される赤血球とともにドナーに戻される抗凝固剤と間質液の移動を計算に入れる、請求項27または請求項28に記載の方法。
- Vbは、ドナーの体重、身長、性別、年齢、および形態を含む1つまたは複数のドナー固有の特性に基づいて決定される、請求項27から請求項29までのいずれか1項に記載の方法。
- 血漿を収集するための方法は、
a)ドナーの体重を決定すること、
b)ドナーのヘマトクリット値を決定すること、
c)採取を開始する前に、ドナーの体重およびヘマトクリット値に少なくとも部分的に基づいて、収集される原料血漿の体積および/または目標血漿生成物の収集体積を決定すること、
d)ドナーから全血を採取すること、
e)指定された比率で全血に抗凝固剤を加えること、
f)抗凝固全血を、抗凝固血漿と、赤血球を含む抗凝固処理された第2の成分とに分離すること、
g)分離された抗凝固血漿を容器に収集し、そして、
h)先に決定された体積の原料血漿および/または目標体積の血漿生成物が収集された後、抗凝固処理された第2の成分のドナーへの最終的な返送を開始することを含む、方法。 - 抗凝固血漿とは別に容器に導入された容器内の抗凝固剤を計算に入れることをさらに含む、請求項27に記載の方法。
- 抗凝固血漿とは別に導入された容器内の抗凝固剤が、プライミングまたは他の前処理工程に使用される抗凝固剤に起因する、請求項28に記載の方法。
- ドナーの性別を決定し、そして、収集を開始する前に、少なくとも部分的にドナーの体重、ヘマトクリット値、および、性別に基づいて、収集される原料血漿の体積および/または血漿生成物の目標体積を決定することをさらに含む、請求項27から請求項29までのいずれか1項に記載の方法。
- ドナーの身長を決定し、そして、収集を開始する前に、少なくとも部分的にドナーの体重、ヘマトクリット値、および、身長に基づいて、収集される原料血漿の体積および/または血漿生成物の目標体積を決定することをさらに含む、請求項27から請求項29までのいずれか1項に記載の方法。
- ドナーの身長と性別を決定し、そして、収集を開始する前に、少なくとも部分的にドナーの体重、ヘマトクリット値、身長、および、性別に基づいて、収集される原料血漿の体積を決定することをさらに含む、請求項27から請求項29までのいずれか1項に記載の方法。
- 血漿を収集するためのシステムであって、
ドナーから全血を採取するための静脈穿刺針と、
血漿生成物と赤血球を含む第2の血液成分とに全血を分離するための血液分離器であって、血漿生成物成分を血漿生成物収集容器に送るための血漿ラインに接続された血漿出力ポートを有する血液分離器と、
第1のポンプによって制御される第1のラインを通して、全血をドナーから前記分離器に導入し、濃縮赤血球をドナーに戻すために前記静脈穿刺針に流体的に接続されたドナーラインと、
抗凝固剤源に接続された抗凝固剤ラインであって、抗凝固剤を前記ドナーラインに導入するように構成された抗凝固剤ラインと、そして
血液成分分離装置および前記第1のポンプの動作を制御するように構成された制御部であって、(1)第1の採取段階の前に収集される目標のドナー原料血漿体積および/または収集される目標血漿生成物体積を、少なくとも部分的に、ドナーの体重、身長、性別、およびヘマトクリット値に基づいて計算するように構成され、目標ドナー原料血漿体積に追加される抗凝固剤の体積は抗凝固剤比とドナーのヘマトクリット値に基づいて計算されるように構成されている制御部とを備える、システム。 - 前記制御部は、各採取段階の前に、ドナーのヘマトクリット値および前記目標血漿生成物収集体積を決定するようにさらに構成される、請求項37に記載のシステム。
- 前記制御部は、前記血漿収集容器内の血漿生成物の測定された体積が前記目標血漿生成物収集体積に等しいときに、第2の血液成分の最終的な返送を開始するようにさらに構成される、請求項36または請求項37に記載のシステム。
- 前記制御部は、血漿生成物とは別に前記血漿収集容器に導入された抗凝固剤を計算に入れるようにさらに構成される、請求項36から請求項39までのいずれか1項に記載のシステム。
- 前記制御部は、血漿生成物とは別に、プライミングまたは他の前処理工程に起因して前記血漿収集容器に導入さた抗凝固剤を計算に入れるようにさらに構成される、請求項36から請求項40までのいずれか1項に記載のシステム。
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