JP2022533644A - 標的領域を特定するための装置および方法 - Google Patents
標的領域を特定するための装置および方法 Download PDFInfo
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Abstract
Description
本出願は、2019年5月16日付で出願した米国特許出願第16/414,499号に対して優先権を主張するものであり、その内容の全体がこの参照により本明細書に組み込まれる。
図2を参照すると、システム10は、薬物注入処置中に駆動装置50と協働自在な注入アセンブリ20を含む。この注入アセンブリは、注射器18と、ハンドピースまたは針24と、注射器をハンドピースに接続する流体ライン22とを含む。
上述したように、システム10は、制御された薬物の流れを注入アセンブリ20に提供する液体送達システム50を含む。液体送達システムは自動システムであることが好ましく、本実施形態においては、駆動装置50として言及する、コンピュータ制御された液体送達システムである。
上記で説明したように、液圧を利用してシステム10の動作を制御することができる。例えば、液圧が所定の閾値を超えた場合、本システムは操作者に信号を提供することで、針が硬膜などの密性組織に対してまたはそのような密性組織内に配置されていることを示すことができる。針の吐出口における液圧の計算にはいくつかの方法がある。
上述したように、システム10は、当該システムまたは操作者が拍動波形の存在を検出するために圧力データを分析している間、針を通して液体を継続的に注入するように構成されている。しかしながら、液体の注入によって拍動波形の検出に影響を与える外乱が生じる可能性がある。例えば、液流から生じる乱流、および注射器内のゴム製/エラストマー製ピストンの静止摩擦力は、拍動波形の検出に悪影響を及ぼす2つの変数である。本システムは、このような外乱により生じる潜在的問題を克服するために、当該外乱の影響から拍動波形を分離するように構成することができる。
本システムは、利用者によって操作可能な入力機構を含み、これにより操作者は当該システムを制御するための入力信号を提供することが可能となる。前記入力機構は、タッチスクリーン、駆動装置上のボタン、または操作者が単一の流量を開始、停止、また単一の流量から第2または第3の事前設定された異なる流量に変更するための手段を提供する足踏み式制御装置などの様々な装置のうちの任意の装置であってよい。代替的に、入力要素は、マウス、キーボード、または音声入力コマンドを提供するマイクロホンであってもよい。さらに、本システムは、処置の様々な段階で操作者が様々な入力を入力することを可能とする複数の入力機構を含むことができる。例えば、本システムは、装置を通過する液流を制御する足踏み式ペダルなどの第1の入力機構を含むことができる。足踏み式ペダルのスイッチを作動(すなわち、スイッチを押す)ことにより、駆動装置のCPUに信号が送信され、これによってモータを駆動するための信号がモータに送信され、ペダルが作動中である限り液体が注射器から針24に流動する。代替的に、足踏み式ペダルを最初に作動させた段階で開始信号が駆動されて液体の流動が開始され、操作者が再び足踏み式ペダルを作動させるまで液体の流動が継続するようにしてもよい。このような態様により、第2の作動は停止信号として機能して液体の流動が中断される。
上記のシステムを使用して針を標的位置に案内する例示的な方法について以下説明する。本システムは、薬物注入用の針を案内する使用用途に限定されるものでないことを理解されたい。したがって、以下に説明する原理および方法は、様々な用途および処置における針の組織および解剖学的領域への挿入に容易に適応可能であることを理解されたい。
Claims (20)
- 患者の体内の標的位置に液体を投与するための、針を備えた装置であって、
前記針に供給される液体を保管する液体リザーバと、
前記液体リザーバから液体を流出させるために前記液体リザーバに対して相対移動自在な吐出要素と、
前記吐出要素と係合して前記吐出要素の移動を制御するように構成された駆動要素と、
前記駆動要素を制御して前記液体リザーバから前記針に流動する液流を制御するように動作可能な制御装置と、
前記針内の液圧を表す特徴を検出するセンサであって、当該針を備えた装置が対象者の体内に挿入されている間、継続的に前記特徴を検出するように構成されているものである、前記センサと、
前記液体リザーバおよび前記センサと液体連通する可撓性導管であって、径方向において実質的に剛性を有するものである、前記可撓性導管と
を有し、
前記制御装置は定期的に前記駆動要素の動作を中断し、拍動波形を表す1若しくはそれ以上の特徴を検出するために前記センサからのデータを処理するものであり、
前記可撓性導管、前記液体リザーバ、前記吐出要素、および前記駆動要素は、前記針と前記液体リザーバとの間の液量が実質的に一定となるように構成されており、それにより、前記駆動要素の動作が停止された際、前記センサによって前記針内部の残留液を通過する拍動波形を正確に検出することが可能となるものである、
針を備えた装置。 - 請求項1記載の針を備えた装置において、前記液体リザーバは注射器の円筒部である、針を備えた装置。
- 請求項1または2記載の針を備えた装置において、前記吐出要素は、前記液体リザーバの内部でスライド自在に移動可能なものである、針を備えた装置。
- 請求項1~3のいずれか1つに記載の針を備えた装置において、前記制御装置は、前記センサからのデータを分析して抵抗消失を表す1若しくはそれ以上の特徴を検出するように構成されているものである、針を備えた装置。
- 請求項4記載の針を備えた装置において、前記制御装置は、前記1若しくはそれ以上の特徴の検出に応答して前記駆動要素の動作を中断し、拍動波形を表す1若しくはそれ以上の特徴を検出するために前記センサからのデータを処理するものである、針を備えた装置。
- 請求項5記載の針を備えた装置において、前記制御装置は、抵抗消失を表す信号および拍動波形の存在を表す信号を前記針において受信した際、前記針が標的組織に隣接して適切に配置されていることを示す検証信号を提供するように構成されているものである、針を備えた装置。
- 請求項1~6のいずれか1つに記載の針を備えた装置において、前記針における液圧を時間の関数として、抵抗消失による案内手順と一致する態様で表示するように構成された第1の出力部を含む表示装置を有するものである、針を備えた装置。
- 請求項7記載の針を備えた装置において、前記制御装置は、拍動波形を表すデータを分離するために前記センサからのデータを処理するように構成されており、前記表示装置は、前記第1の出力部が第1の部分において液圧を時間の関数として表示する間、前記拍動波形を表すデータを表示するように構成された第2の出力部を有するものである、針を備えた装置。
- リザーバと液体連通する針により対象者の体内にある標的領域の位置を特定する方法であって、
i)注入液を含むリザーバ、および一方の端部において前記リザーバと連通し、もう一方の端部において前記対象者の体内に挿入される前記針と接続されたチューブを提供する工程と、
ii)前記注入液が前記針を通して前記対象者の体内に注入された際に当該注入液の抵抗測定値に関するデータを取得する工程と、
iii)前記針を前記対象者に前進させる工程と、
iv)前記前進させる工程の間に前記対象者に対して前記注入液を注入する工程と、
v)前記針を前進させる工程および前記注入液を注入する工程を断続的に中断する工程と、
vi)前記断続的に中断する工程の間に前記針内の液圧に関するデータを取得する工程と、
vii)前記針における拍動波形を表す1若しくはそれ以上の特徴を検出するために前記断続的に中断する工程の間に取得された前記液圧に関するデータを処理する工程と
を有する方法。 - 請求項9記載の方法において、前記断続的に中断する工程の後、前記針を前進させる工程および前記注入液を注入する工程を再開する工程を有するものである、方法。
- 請求項9記載の方法において、前記注入液が前記対象者の体内に注入される際の液流に関連するノイズを除去して前記針内の液圧に関するデータを処理する工程を有するものである、方法。
- 請求項11記載の方法において、前記注入液を注入する工程の間、ポンプは前記注入液を注入するように動作可能であり、前記ノイズを除去する工程は、
前記針を前記対象者の体内に挿入する前に前記ポンプを作動させる工程と、
前記ポンプを作動させる工程の間にノイズに関するデータを取得する工程と、
前記取得された前記ノイズに関するデータに応答して前記液圧に関するデータを修正する工程と
を有するものである、方法。 - 請求項9記載の方法において、前記処理する工程は、拍動波形を特定する試みを実行するために、処理データの振幅範囲を選択的に変更する工程を有するものである、方法。
- 患者の体内に針を挿入する方法であって、
針を前記患者の体内の標的位置に配置する試みを行うために抵抗消失法の手順を実行する工程であって、
前記患者の体内に針を挿入する工程と、
前記挿入する工程の間に前記針を通して液体を注入する工程と、
前記液体を注入する工程の間に前記針における液圧を検出する工程と、
前記液圧を検出する工程に応答して前記針を案内する工程と、
を有するものである、前記抵抗消失法の手順を実行する工程と、
前記針における拍動波形の存在を検出する工程であって、前記針が前記患者の体内で実質的に静止状態にあるときに前記針における液圧を検出する工程を有するものである、前記拍動波形の存在を検出する工程と、
前記抵抗消失法の手順を実行する工程により前記針が前記標的位置にあることが示され、かつ前記拍動波形の存在を検出する工程により拍動波形の存在が示された後、薬物をボーラス注入する工程と
を有する方法。 - 請求項14記載の方法において、前記抵抗消失法の手順を実行する工程と前記拍動波形の存在を検出する工程を断続的に切り替える工程を有するものである、方法。
- 請求項15記載の方法において、前記液体を注入する工程は、液体リザーバから液体を分注するために、駆動装置を電子的に制御する工程を有するものである、方法。
- 請求項16記載の方法において、前記液体を注入する工程は、前記液圧を検出する工程に応答して前記駆動装置を電子的に制御する工程を有するものである、方法。
- 対象者の体内に位置する解剖学的空間である標的領域の位置を特定する装置であって、
注入液を受容するリザーバと、
前記リザーバと液体連通する導管と、
前記導管内の液圧を表す特徴を検出するように動作可能なセンサと、
前記リザーバから前記導管に液体を注入するように構成されたポンプと、
前記センサからの前記導管内の液圧に関するデータを処理するように動作可能な制御装置と、
を有し、
前記制御装置は、拍動波形を特定するために、前記導管が静止状態にあるときに前記センサからの前記データを処理するように構成されているものであり、
前記制御装置は、前記導管の挿入を案内するための信号を提供するように構成されており、当該信号は前記センサからの前記データに応答して提供されるものであり、
当該装置はさらに、拍動波形を特定する試みを実行するために、処理データの振幅範囲を選択的に変更するための入力機構を有するものである、
装置。 - 請求項18記載の装置において、前記導管は鋭利先端部を有する中空の針である、装置。
- 請求項18記載の装置において、前記導管は前記センサと液密接続されたカテーテルである、装置。
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KR102422932B1 (ko) | 2022-07-21 |
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CN113853226B (zh) | 2024-06-14 |
US10646660B1 (en) | 2020-05-12 |
US20210085889A1 (en) | 2021-03-25 |
SG11202112691TA (en) | 2021-12-30 |
EP3969082A1 (en) | 2022-03-23 |
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