JP7346309B2 - 流体送達性能を改善するための流体経路インピーダンス評価 - Google Patents
流体送達性能を改善するための流体経路インピーダンス評価 Download PDFInfo
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- JP7346309B2 JP7346309B2 JP2019572202A JP2019572202A JP7346309B2 JP 7346309 B2 JP7346309 B2 JP 7346309B2 JP 2019572202 A JP2019572202 A JP 2019572202A JP 2019572202 A JP2019572202 A JP 2019572202A JP 7346309 B2 JP7346309 B2 JP 7346309B2
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- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
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Description
オーバートラベル(ml)=C1+C2*x+C3*x^2+C4 *x^3+C5*y+C6*y^2+C7*y^3
(ここで:C1=-0.811;C2=0.039;C3=-0.00035;C4=9.05E-7;C5=0.0269;C6=-4.43e-5;C7=2.607e-8;x軸=圧力;y軸=位置)
流体注入システムから第1の流体720の所望の量を受け取るには、プランジャ726をオーバートラベルしなければならず、次にそのオーバートラベルと同じ量だけ逆に引き戻して、第1の流体720シリンジのキャパシタンス量を補償する必要がある。
式(A):第2段階の圧力(psi)=13.07×FR+18.8
圧力(psi)=13.07×FR+18.8
以下の式は、本開示全体に記載されるように、流体注入システムのインピーダンスをモデル化、評価、予測、利用、および/または制御するさまざまな方法を可能にする。数学的な関係で流体の流れを記述するときは、一貫した単位を使用することが重要である。下付き文字は変数を識別するために変数とともに使用され、以下の表で定義されている。
多くの場合、式1に示す関係は、通常、圧力が流量に対してプロットされている特定のシステムに対して経験的に決定される。これらのプロットの一部は、特定の分野向けに修正されている。例えば、パイプ(例えば、ガスパイプライン)を使用する産業では、パイプの長さあたりの圧力損失が流量の関数として示され、直径と流体の組み合わせごとに個別の曲線が示される。
液圧抵抗には複数のメカニズムがある。以下は、チューブとカテーテルに共通する2つのメカニズムである。
混合流体には、混合の特徴によって計算される特性がある。均一に混合すると、混合物の比率に比例した特性値を得ることができる。例えば、造影剤の体積が40%である造影剤と生理食塩水の均一な混合物の混合密度ρmixは、式4で与えられる:
ρmix=0.4ρcontract+(1-0.4)ρsaline (式4)
RTOTAL,iは次のように単純化できることに留意されたい:
図2のような断面積A0,j,i[inches2]のプランジャを備えたjのラベルが付いたシリンジ内の注入器ピストンが時間増分iで量Δyj,i[inches]を移動する場合、理論的にピストンによって移動される流体の体積は、レート
放射線医学に使用される現代の注入器は、線形弾性で、負荷がかかると曲がり、実際の流量に測定可能なほど影響するアセンブリクリアランスを有する多くの熱可塑性および熱硬化性ポリマー部品で作られている。超弾性のポリマーゴム部品も一般的なアセンブリの一部であり、多くの熱可塑性ポリマーよりも剛性が大幅に低く、さらに実際の噴射率に桁違いに影響する。
図4に示すローリングダイヤフラムなどの一部のシリンジコンポーネントは、塑性変形により永久に変形する場合がある。塑性変形に耐えるコンポーネントを使用した流体送達に使用されるアルゴリズムでは、塑性ひずみの適切な関係を使用しなければならない。
流体の送達中の圧力変化により、システムのポテンシャル、弾性、およびひずみエネルギーが変化する。本明細書で説明するように、圧力を上げると、システムコンポーネントの全体的な内部容積および/またはシステムコンポーネントにかかる圧縮力が増大し、その結果、収縮が生じる。
液圧キャパシタンスCh,j,i(コンプライアンスまたは弾性とも呼ばれる)は、V0,j,i[inches3]とラベル付けされたゼロ圧力および時間iでの容積jと、式8で与えられる有効体積膨張率
V0,j,i=V0,j,i-Δt-A0,j,iΔyj,i (式9)
膨張率の例は、終端効果を無視する長いチューブの式10で与えられる:
時間iでのキャパシタンスの量は、残量Vresidual.j.i[inches3]であり、これは、これらのコンポーネントに適用された圧力Piに起因する流体送達システムのコンポーネントの弾性膨張および/または弾性形状変化によるものである:
Vj,i=V0,j,i+Vresidual.j.i (式12)
Ch,TOTAL,i=Ch,A,i+Ch.B,i (式14)
同じコンポーネントが圧力の増加に伴って膨張および/または圧縮し、かつ/または圧力の減少に伴って拡張するため、圧力が低下すると、キャパシタンスに流入するのと反対方向にキャパシタンスから流出する。キャパシタンスの流出入の効果は、ピストン変位の体積率を説明するために、上記の式の右側に追加される:
アセンブリを可能にするために、部品間のクリアランスの可能性については前に説明した。機械的リンク機構の寸法公差条件により変位が許容され、その結果そのようなクリアランスによってΔyj,iが効果的に変更される場合、そのようなクリアランスはΔyj,iに加算または減算する。
多くの場合、キャパシタンスと残量の経験的な決定は、計算よりも効率的で正確である。計算で使用される多くのパラメータは、まだ経験的に取得しなければならない。通常、2つの方法の組み合わせが使用される。
残量Vresidual.j.iは式12で与えられた。
シリンジは常にその容量まで充填されているわけではないため、充填量VFILL,j[inches3]はゼロ圧力で定義され、充填されるシリンジの長さLFILL,jを計算できる:
VACTUAL,j,i[inches3]=Aj,iFluid Lengthj,i (式25)
Vresidual,j,i[inches3]=VACTUAL,j,i-Vj,i (式26)
総システムキャパシタンスは、各流体送達システムおよびそのさまざまな流体経路要素に固有であり、注入器構造、シリンジ、プランジャ、シリンジを囲む圧力ジャケット、特定の量を変化させる異なる流体の分子間の相互作用、および流体を患者に送達する流体ラインの構築に使用される材料の機械的特性;シリンジ、プランジャ、圧力ジャケットのサイズ;チューブの長さと直径;圧力下で流体が通過しなければならないオリフィスや曲げ部などの局所的な形状の変化;温度変化、温度勾配、粘度、密度などの流体特性を含むがこれらに限定されない、システムに残っている流体の圧力および量を超える複数のファクタに依存する。
残量式:
上記の式は、圧力が変化すると、液圧キャパシタンスの残量の流入または流出が発生することを示している。式16は、ピストンの動きが変位し、キャパシタンスに流入またはキャパシタンスから流出する量の差を定量化して、注入された量を減算または加算する。図51は、急激に変化する液圧システムの流体特性と、粘度、密度、弁位置などの特徴の影響を示している。これらの変化は、流れに対する抵抗と流量の両方を比例的かつ瞬時に変化させるが、圧力は、液圧キャパシタンスと液圧抵抗の積である時定数τiによって支配される指数関数的なレートで変化する。τiの計算が以下の式32で与えられる:
理想的には、Piはリアルタイムで取得したデータとして、またはデータベースからアクセスして利用できる。圧力データが利用できない場合、定常状態値と初期条件が与えられていれば、Piは移行時間範囲にわたって計算され得る。過渡圧力を分析的に決定するために必要な計算の例を以下に示す。
Ti=RTOTAL,iCh,TOTAL,iおよび
ここで、Δt=i-(i-Δt) (式47)
理論が予測するように圧力は流量の変化に遅れ、図51は造影剤注入が終了し生理食塩水注入が開始される際のキャパシタンスを備えたシステムで示している。圧力がデータベースまたはリアルタイムデータとして利用できない場合は、造影剤から生理食塩水への移行中に増加的に計算できる。重要なのは、Tiとラベル付けされた時定数のファクタとして前の流量
τi=RTOTAL,i-ΔtCh,TOTAL,i (式54)および、
リアルタイムデータまたはデータベースがない場合、造影剤から生理食塩水への移行を介して圧力と流量を定量化する式33~式58’の指数関係は、処理の開始と終了の両方で定常状態までの期間も表す。2つのシリンジが弁で隔離されていない生理食塩水の注入で流れる造影剤注入の計算例は次のとおりである。
反復は、時間および/またはストローク長の増分の基準を通じて継続される。生理食塩水を含む新しいシリンジBが注入を開始すると、密度と粘度を含む流体特性は、チューブ内の混合物ρmixとμmixの特性となり、これは、約1mlしかないため、影響は最小限である。
Fluid LengthB,i=LFILL,B[inches]+ΔLP,B,i+ΔLS,B,i (式63)
そして、流体の長さと直径は圧力Piに比例するため、
本明細書で議論されるように、多段階注入は、造影剤または第1段階に続く第2段階もしくは生理食塩水洗浄段階を含むことができる。生理食塩水洗浄段階の開始時、導管または流体経路は造影剤で満たされており、これは通常、生理食塩水よりも密度が高く、体積弾性率も高い非常に粘性の高い流体である。注入が進むと、導管または流体経路に導入された生理食塩水が、流体経路に残っている造影剤を置き換え始める。生理食塩水洗浄が導管とカテーテルの端に達すると、生理食塩水と造影剤との間の液圧抵抗の違いにより、圧力Piが大幅に低下し始める。その結果、Pi>PSTEADY STATE,jであるため、第2段階の初期部分の流量
流体送達システムコントローラによって計算され、使用され得るインピーダンスモデルの例が、式1から式65に示されている。いくつかの例では、モデルを反復コンピュータプログラムで使用して、時間iでシリンジjから流出する流体の実際の体積流量Qj,iを決定することができる。モデルで説明されているように、流体の流れは2つの効果の合計であり、つまり、ピストンの動き
12 シリンジ
12a シリンジ
12b シリンジ
13 シリンジポート
14 プランジャ
15 長手方向軸
17 流体経路セット
18 円筒形バレル、円筒形シリンジバレル
19 駆動部材、ピストン
20 近位端
21 外面
22 ノズル
23 内面
24 遠位端
25 内部容積
30 挿入セクション
31 モータ
32 圧力ジャケット
34 ローリングダイヤフラムシリンジ
36 本体
38 内部容積
40 遠位端
42 近位端
44 側壁
46 閉端壁
48 排出ネック
50 中央部分
52 駆動部材係合部
54 ハウジング
56 MUDS
58 シリンジ、ポンプ
58a シリンジ
60 バルク流体コネクタ
62 MUDS流体経路
64 フレーム
66 充填ポート
68 排出出口、導管
70 マニホールド
72 弁
74 流体出口ライン
76 ポート
112 流体経路セット
119 側壁
200 カテーテルチューブ
210 カテーテル
220 シリンジ
230 シリンジインタフェース
240 ピストンヘッド、プランジャヘッド
250 ピストン
260 ポリマーカバー
270 ひずみゲージキャップ
300 超音波または質量流量センサ
310 空気センサ
400 システム
410 イメージング機器
412 経路
414 撮像装置コントローラ、コンピュータシステム
416 ユーザインタフェース
420 流体注入システム
422 モータ制御回路、モータコントローラ
422z コネクタまたは弁
424 注入器コントローラ、コンピュータシステム
426 ユーザインタフェース
428 経路
430a、430b~430n 流体送達サブシステム
431a モータ
432a ドライブトレイン
434 マウント部、マウント
436a ピストン
437a ピストンヘッド
438a プランジャ
440a シリンジバレル、シリンジ
442a 流体経路導管
444a 流体経路要素
444z 流体経路要素
450a センサ、エンコーダ
452a センサ
454a センサ
456a センサ
458a センサ
470 カテーテル
500 開ループ制御システム、開ループシステム
501 入力信号
502 閉ループ制御システム
503 インタフェース
504 制御システム、フィードバックループ
504a 位置フィードバック制御システム、フィードバックループ
504b 圧力限界制御システム、フィードバックループ
504c フィードバックループ
506a 第1の位置フィードバックループ
506a’ 第2の位置フィードバック
510 エフェクタサブシステム
511 電圧制御信号、速度
513 フィードバック信号
515 制御信号
515b 出力信号
515b’ 出力信号
517 出力
518 ユーザインタフェース
520 コントローラ
522 信号結合器
522a 結合器
522a’ 結合器
524 コントローラ
524a コントローラ
524b コントローラ
524c コントローラ
526 センサ
526a センサ
526b センサ
526c センサ
527 信号
527a 信号、入力
527b センサ信号、入力
527c センサ信号
528 コンディショナ
528a コンディショナ
528b コンディショナ
528c コンディショナ
529 フィードバック信号、速度
560 データシステム
621 トレース
622 トレース
623 トレース
710 造影剤
712 生理食塩水
720 第1の流体
722 第2の流体
724 コントローラ、注入制御機構
725 モータ
726 プランジャ
727 モータ
728 プランジャ
740 逆止弁、高クラッキング圧力弁
742 逆止弁、高クラッキング圧力弁
744 圧力ジャケット
746 圧力ジャケット
748 閉塞部材
750 開口部
752 外部制限部材
756 流れ均等化弁
Claims (14)
- 流体注入システムの流体送達性能を改善する方法であって、前記方法は、
1つまたは複数の流体の送達を開始する前に、コントローラが、1つまたは複数の既知の推定または測定されたパラメータに基づいて、前記流体注入システムのインピーダンスに影響する1つまたは複数のファクタをモデル化するステップと、
前記コントローラが、第1の流量で前記1つまたは複数の流体の少なくとも第1の流体の送達を開始するステップと、
センサが、流体送達の1つまたは複数の特性を測定するステップと、
前記コントローラが、前記流体送達の前記1つまたは複数の特性の1つまたは複数の測定に基づいて、前記流体注入システムのインピーダンスに影響する1つまたは複数のファクタをモデル化するステップと、
前記コントローラが、流体送達性能を改善するために、前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータでモデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の測定でモデル化された、ファクタに基づいて、前記流体注入システムの1つまたは複数の特性を調整するステップと、
を含み、
前記流体注入システムのインピーダンスが、入力アクション、力、またはエネルギーと、出力アクション、力、またはエネルギーと、の間の関係を含み、保存された回復不能なアクション、力、またはエネルギーを含み、不動作または遅延動作を含む、方法。 - 前記コントローラが、第2の流量で少なくとも第2の流体の送達を開始するステップをさらに含む、請求項1に記載の方法。
- 前記コントローラが、前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータでモデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の測定でモデル化された、ファクタによって行われまたは示唆される少なくとも1つの調整を前記流体注入システムのオペレータに通知する、請求項1または2に記載の方法。
- 前記コントローラが、流体の送達の前に、前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータでモデル化された、ファクタに基づいて前記流体注入システムの前記1つまたは複数の特性を調整するステップをさらに含む、請求項1から3のいずれか一項に記載の方法。
- 前記コントローラが、流体送達性能を改善するために、前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータでモデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の測定でモデル化された、ファクタに基づいて、前記流体注入システムの1つまたは複数の特性を調整するステップが、前記第1の流体の送達中に生じる、請求項1に記載の方法。
- 前記コントローラが、第2の流量で少なくとも第2の流体の送達を開始し、流体送達性能を改善するために、前記第1の流体または前記第2の流体のいずれかの送達中に、前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータでモデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の測定でモデル化された、ファクタに基づいて前記流体注入システムの前記1つまたは複数の特性を調整するステップをさらに含む、請求項5に記載の方法。
- 前記1つまたは複数のパラメータが、温度、粘度、圧力、体積弾性率、濃度、カテーテルサイズ、液圧抵抗、所望の流量、およびシステムキャパシタンスである、請求項1または5に記載の方法。
- 前記流体送達の前記1つまたは複数の特性が、温度、粘度、圧力、体積弾性率、液圧抵抗、実際の流量、およびシステムキャパシタンスである、請求項1または5に記載の方法。
- 前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータでモデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の測定でモデル化された、ファクタに基づいた、前記流体注入システムの前記1つまたは複数の特性の前記調整が、前記第1の流体および前記第2の流体の両方の送達中に発生する、請求項6に記載の方法。
- 前記センサが、前記流体送達の1つまたは複数の特性を再測定するステップと、
前記コントローラが、1つまたは複数の既知の推定または測定されたパラメータまたは前記流体送達の前記1つまたは複数の特性の1つまたは複数の再測定に基づいて、前記流体注入システムのインピーダンスに影響する1つまたは複数のファクタを再モデル化するステップと、
前記コントローラが、流体送達性能を改善するために、前記第1の流体の送達中に、前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータで再モデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の再測定で再モデル化された、ファクタに基づいて前記流体注入システムの前記1つまたは複数の特性を再調整するステップと、
をさらに含む、請求項5に記載の方法。 - 流体注入システムの流体送達性能を改善する方法であって、前記方法は、
1つまたは複数の流体の送達を開始する前に、コントローラが、1つまたは複数の既知の推定または測定されたパラメータに基づいて、前記流体注入システムのインピーダンスに影響する1つまたは複数のファクタをモデル化するステップと、
前記コントローラが、第1の流量で前記1つまたは複数の流体の少なくとも第1の流体の送達を開始するステップと、
センサが、流体送達の1つまたは複数の特性を測定するステップと、
前記コントローラが、前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の測定に基づいて、前記流体注入システムのインピーダンスに影響する1つまたは複数のファクタをモデル化するステップと、
前記コントローラが、前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータでモデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の測定でモデル化された、ファクタに基づいて、前記流体注入システムの1つまたは複数の特性を調整するステップと、
前記コントローラが、第2の流量で前記1つまたは複数の流体の少なくとも第2の流体の送達を開始するステップと、
前記センサが、前記流体送達の1つまたは複数の特性を再測定するステップと、
前記コントローラが、1つまたは複数の既知の推定または測定されたパラメータまたは前記流体送達の前記1つまたは複数の特性の1つまたは複数の再測定に基づいて、前記流体注入システムのインピーダンスに影響する1つまたは複数のファクタを再モデル化するステップと、
前記コントローラが、流体送達性能を改善するために、前記第1の流体または前記第2の流体の送達中に、前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータで再モデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の再測定で再モデル化された、ファクタに基づいて前記流体注入システムの前記1つまたは複数の特性を再調整するステップと、
を含み、
前記流体注入システムのインピーダンスが、入力アクション、力、またはエネルギーと、出力アクション、力、またはエネルギーと、の間の関係を含み、保存された回復不能なアクション、力、またはエネルギーを含み、不動作または遅延動作を含む、方法。 - 前記流体注入システムのインピーダンスに影響する前記1つまたは複数のファクタであって、前記1つまたは複数の既知の推定または測定されたパラメータでモデル化された、または前記流体送達の前記1つまたは複数の特性の前記1つまたは複数の再測定でモデル化された、ファクタに基づいた前記流体注入システムの前記1つまたは複数の特性の前記再調整が、前記第1の流体および前記第2の流体の両方の送達中に発生する、請求項11に記載の方法。
- 表または式または第1段階中に測定された圧力の少なくとも1つから第2の圧力限界を導出するステップをさらに含む、請求項12に記載の方法。
- 前記第2の圧力限界は、前記第1の流体の特徴、前記第2の流体の特徴、カテーテルゲージ、所定の所望の流量、流体注入器のシリンジのピストンの位置、およびそれらの組み合わせのうちの少なくとも1つまたは複数に従って導出される、請求項13に記載の方法。
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