JP5845260B2 - Ｅｃｇ支援カテーテル先端配置の再確認 - Google Patents

Ｅｃｇ支援カテーテル先端配置の再確認 Download PDF

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JP5845260B2
JP5845260B2 JP2013524999A JP2013524999A JP5845260B2 JP 5845260 B2 JP5845260 B2 JP 5845260B2 JP 2013524999 A JP2013524999 A JP 2013524999A JP 2013524999 A JP2013524999 A JP 2013524999A JP 5845260 B2 JP5845260 B2 JP 5845260B2
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ecg signal
catheter
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electrode
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パワーズ，ケリー・ビー
ビーズリー，ジム・シー
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CR Bard Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0006—ECG or EEG signals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/287—Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6851—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7246—Details of waveform analysis using correlation, e.g. template matching or determination of similarity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/08—Sensors provided with means for identification, e.g. barcodes or memory chips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/35—Detecting specific parameters of the electrocardiograph cycle by template matching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/085—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating body or organic structures, e.g. tumours, calculi, blood vessels, nodules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided

Description

[0001]関連出願の相互参照
本出願は、２０１０年８月２０日に出願され、「System for Reconfiguration of ECG-Assisted Catheter Tip Placement」と題する米国仮特許出願第６１／３７５，４４２号の利益を主張し、その仮特許出願は参照によりその全体が本明細書に援用される。
[0002]簡潔に要約すると、本発明の実施形態は、患者のＥＣＧ信号の支援により配置されたカテーテル又は他の留置デバイスの位置を再確認することに向けられる。本明細書において記述されるシステム及び方法によれば、留置カテーテルの遠位先端が、そのカテーテルが最初に配置されたときと同じ場所に配置されたままであるか否かを臨床医が確認できるようになる。先端が別の位置に動いたことがわかった場合には、先端をその適切な位置に戻すために、ステップを実施することができる。
[0003]一実施形態において、患者の体内にある留置医療デバイスの位置を再確認するための方法は、最初に、患者のＥＣＧ信号を用いて患者の体内に医療デバイスを配置することを含む。医療デバイスの初期配置が完了した後に留置医療デバイスの初期位置に関連する第１のＥＣＧ信号プロファイルが記憶される。その後、医療デバイスの初期配置後の或る時間において留置医療デバイスの位置に関連する第２のＥＣＧ信号プロファイルが取得される。第１のＥＣＧ信号プロファイルを第２のＥＣＧ信号プロファイルと比較して、医療デバイスの初期配置後に留置医療デバイスの変位が生じたか否かを判断する。変位が生じた場合には、必要に応じてカテーテルを位置決めし直すために、臨床医は必要なステップを実施することができる。
[0004]本発明の実施形態のこれらの特徴及び他の特徴は、以下の説明及び添付の特許請求の範囲から更に十分に明らかになるか、又はこれ以降に説明される本発明の実施形態を実践することによって習得することができる。
[0005]本開示の更に詳細な説明が、添付の図面に例示されるその具体的な実施形態を参照することによって行われる。これらの図面が本発明の典型的な実施形態のみを示すこと、それゆえ、本発明の範囲を制限すると見なされるべきでないことは理解されたい。添付の図面を用いて、本発明の例示的な実施形態が更に具体的かつ詳細に記述及び説明される。
[0006]本発明の１つの例示的な実施形態による、カテーテルを血管内に配置するためのシステムの種々の要素を示すブロック図である。 [0007]患者と、図１のシステムの支援によって患者内に挿入されるカテーテルとの簡易図である。 [0008]一実施形態による、図２のカテーテル内の導電性経路構成の一部破断図である。 [0009]一実施形態に従って使用するためのカードリーダ／エンコーダシステムの斜視図である。 [00010]一実施形態による、ＲＦＩＤチップを含むカテーテル分岐の平面図である。 [00011]ＲＦＩＤリーダ／エンコーダの簡易平面図である。 [00012]一実施形態による、カテーテルの位置を確認する際のシステム使用中の複数のＥＣＧ波形を示す、図２のシステムのディスプレイの画面表示を示す図である。
[00013]ここで図面が参照されることになり、図面では、類似の構造は類似の参照指示が与えられる。図面は、本発明の例示的な実施形態の、概略かつ模式化した表現であり、限定するものでも、必ずしも原寸に比例して描かれたものでもないことが理解される。
[00014]明確にするために、用語「近位」は本明細書において説明されることになるデバイスを使用する臨床医に相対的に近い方向を指しており、一方、用語「遠位」は臨床医から相対的に遠い方向を指していることは理解されたい。例えば、患者の体内に配置されるカテーテルの端部はカテーテルの遠位端と見なされ、一方、人体の外部に残るカテーテル端は、カテーテルの近位端である。また、特許請求の範囲を含む、本明細書において用いられるときに、用語「〜を含む〜」、「〜を有する」及び「〜を有する〜」は用語「〜を備える〜」と同じ意味を有することになる。
[00015]本発明の実施形態は、包括的には、患者のＥＣＧ信号の支援により配置されたカテーテル又は他の留置デバイスの位置の再確認に向けられる。本明細書において説明されるように、本明細書において説明されるシステム及び方法によれば、特に、留置カテーテルの遠位先端が、そのカテーテルが最初に配置されたときと同じ場所に配置されたままであるか否かを臨床医が確認できるようになる。先端が別の位置に動いたことがわかった場合には、先端をその適切な位置に戻すために、ステップを実施することができる。
[00016]最初に図１及び図２を参照すると、全体として１０で指示されるカテーテル配置及び監視システムの一例が示される。システム１０によれば、超音波イメージングによって患者７０の皮下血管を視覚化し、その後、患者の心臓のＳＡ結節によって生成されたＥＣＧ信号を監視することによって、患者の脈管構造内にカテーテル７２を挿入し、前進させて、最終的に配置できるようになる。システム１０のハードウェア及び他の構成要素の簡易ブロック図が図１に示されており、一方、図２は、患者７０との関連においてシステム及びカテーテル７２を示す。図に示されるように、一実施形態では、システム１０は包括的には、ディスプレイ３０を収容するコンソール２０と、超音波プローブ４０と、患者７０の胸部上に配置するためのセンサユニット５０とを含む。
[00017]より詳細には、かつ上記のように、図２は、皮膚挿入部位７３を通して患者の脈管構造内にカテーテル７２を配置する手順中のシステム１０の構成要素と患者７０との全体的な関係を示す。図２は、カテーテル７２が全体的に、配置が完了した後に、患者の外部に残る近位部分７４と、患者の脈管構造内に存在する遠位部分７６とを含むことを示す。システム１０を用いて、患者の脈管構造内の所望の位置にカテーテル７２の遠位先端７６Ａを最終的に位置決めする。一実施形態では、カテーテル遠位先端７６Ａのための所望の位置は患者の心臓に非常に近く、例えば、上大静脈（「ＳＶＣ」）下３分の１（１／３）の部分内である。当然、システム１０を用いて、カテーテル遠位先端を他の場所に配置することもできる。カテーテル近位部分７４は分岐７４Ａを更に含み、分岐はカテーテル７２の１つ又は複数の内腔と、ハブから近位に延在する１つ又は複数の延長脚部７４Ｂとの間の流体連通を与える。各延長脚部７４Ｂは、適切な医療デバイスに取り付けるためのルアーコネクタ７４Ｃを含む。
[00018]コンソール２０は、システム１０の動作のために必要な種々の構成要素を収容する。例えば、ＥＥＰＲＯＭのような不揮発性メモリを含むプロセッサ２２が、システム１０の動作中のシステム機能を制御し、それにより、制御プロセッサとしての役割を果たすためにコンソール２０に含まれる。デジタルコントローラ／アナログインターフェース２４もコンソール２０に含まれており、プロセッサ２２及び他のシステム構成要素と通信して、超音波プローブ４０、センサ５０及び他のシステム構成要素間のインターフェースを管理する。
[00019]コンソール２０は更に、センサ５０、及びプリンタ、記憶媒体、キーボード等を含むオプションの構成要素５４と接続するためにポート５２を含む。一実施形態では、ポート５２はＵＳＢポートであるが、本明細書において記述されるこのインターフェース接続及び他のインターフェース接続のために他のポートタイプ又はポートタイプの組み合わせを用いることもできる。コンソール２０には、外部電源５８と動作可能に接続できるようにする電力接続５６が含まれる。外部電源とともに、又は外部電源を用いることなく、内部電池６０も利用することができる。コンソールのデジタルコントローラ／アナログインターフェース２４に電力管理回路５９が含まれており、電力の使用及び分配を調整する。
[00020]本実施形態におけるシステム１０のディスプレイ３０はコンソール２０に組み込まれており、カテーテル配置手順中に、そして後に示されるように、以下に記述されることになる実施形態によるカテーテル遠位先端位置の再確認中に、臨床医に情報を表示するために用いられる。オプションでは、ディスプレイは、コンソールとは別にすることができる。一実施形態では、コンソールボタンインターフェース３２及びプローブ４０上に含まれるボタンを用いて、カテーテル配置手順中にシステム１０の機能を制御することができる。したがって、システムコンソール２０の単一のディスプレイ３０を、後に示されるように、患者の脈管構造に近づく際の超音波誘導のために、患者の心臓の結節に対するカテーテル遠位先端配置のＥＣＧに基づく確認のために、そして、カテーテル遠位先端位置の事後確認のために利用することができる。一実施形態では、ディスプレイ３０はＬＣＤデバイスである。
[00021]上記のように、カテーテル７２を脈管構造内に挿入するのに備えて、静脈のような皮下血管を超音波（「ＵＳ」）に基づいて視覚化することに関連して、超音波プローブ４０が用いられる。そのような視覚化は、患者の脈管構造内に（挿入部位７３を介して）カテーテルを導入するためのリアルタイム超音波誘導を与え、不注意による動脈穿刺、血腫、気胸を含む、そのような導入に通常関連する合併症を少なくするのを助ける。
[00022]手持ちプローブ４０はヘッドを含み、ヘッドは、候補となる挿入部位７３に非常に近い患者の皮膚に押し当てて配置されるときに、超音波パルスを生成し、かつ患者の体によって反射された後のそのエコーを受信するための圧電アレイを収容する。プローブ４０は更に、システム１０を制御するための複数の制御ボタンを含むことができ、それにより、システム機能を制御するために、臨床医がカテーテル配置前に患者の挿入部位の周囲に確立された滅菌野から外に手を伸ばすのを不要にする。
[00023]したがって、一実施形態では、臨床医はシステム１０の超音波モダリティを利用して、適切な挿入部位を決定し、針又は導入器、その後、カテーテルによる血管へのアクセスを確立する。その後、臨床医は、プローブ４０上に含まれるボタン上のボタンを押すことによって、ＥＣＧに基づくカテーテル先端誘導モダリティ（後述）に途切れることなく切り替えることができ、滅菌野から外に手を伸ばす必要はない。このようにして、システム１０は、脈管構造を通してカテーテル７２の遠位先端を意図した行先に向かって誘導する際に臨床医を支援する。
[00024]図１は、プローブ４０がボタン及びプローブ動作を管理するための、ボタン及びメモリコントローラ４２を更に含むことを示す。ボタン及びメモリコントローラ４２は、一実施形態において、ＥＥＰＲＯＭのような不揮発性メモリを含むことができる。ボタン及びメモリコントローラ４２は、コンソール２０のプローブインターフェース４４と動作可能に通信し、プローブインターフェースは、プローブ圧電アレイとのインターフェースを形成するための圧電入力／出力構成要素４４Ａと、ボタン及びメモリコントローラ４２とのインターフェースを形成するためのメモリ入力／出力構成要素４４Ｂとを含む。
[00025]上記のように、システム１０は、患者７０の心臓の洞房（「ＳＡ」）又は他の電気インパルス生成結節に対してカテーテル遠位先端７６Ａが近いことを判断し、それにより、その結節に非常に近い所望の場所にカテーテル遠位先端を正確に配置する能力を高めることができる機能を含む。本明細書において「ＥＣＧ」又は「ＥＣＧに基づく先端確認」と呼ばれる、システム１０のこのモダリティによって、患者の脈管構造内の所望の場所にカテーテル遠位先端を配置するために、ＳＡ結節からのＥＣＧ信号を検出できるようになる。ＵＳ及びＥＣＧモダリティは本システム１０において途切れることなく組み合わせられ、カテーテル配置を支援するために同時に、又は別々に利用できることに留意されたい。さらに、磁気素子に基づくカテーテル先端位置決定のような他のモダリティもシステム１０に含むことができる。一実施形態では、本明細書において記述されるようなＥＣＧモダリティは、ＵＳ又は他のモダリティを含むことなく、独立型システムに含まれることができる。したがって、本明細書における実施形態が記述される環境は、単なる環境例として理解され、本開示の制限するものとは見なされない。また、後に更に説明される遠位先端再確認実施形態との関連で、ＥＣＧに基づく他の誘導／監視システムを利用できることにも留意されたい。
[00026]図１及び図２は、挿入部位７３を介して患者７０の中に挿入されるカテーテル７２の内腔内に取外し可能に予め配置されるスタイレット１３０を示す。スタイレット１３０は、ＳＡ結節によって生成されるＥＣＧ信号を検知するために、スタイレット１３０の遠位端の非常に近くに、検知構成要素、すなわち電極を含む。スタイレット１３０は、その近位端から延在し、センサ５０に動作可能に接続するテザー１３４を含む。手短に言うと、スタイレットテザー１３４は、カテーテル前進中にスタイレット１３０の遠位部分上に含まれるＥＣＧ電極によって検出されるＥＣＧ信号をセンサ５０に伝達できるようにする導電性経路を提供する。
[00027]基準及び接地用ＥＣＧ皮膚電極１３８が患者７０の皮膚表面に付着し、センサ５０に動作可能に取り付けられ、システムが、心臓のＳＡ結節の電気的活動に関連しない高レベルの電気的活動を除去できるようにし、それにより、ＥＣＧに基づく先端確認機能を可能にする。患者の皮膚上に配置されるＥＣＧ皮膚電極１３８から受信される基準及び接地信号とともに、スタイレット電極によって検知されたＥＣＧ信号は、患者の胸部上に配置されるセンサ５０によって、又はシステム１０の他の指定された構成要素によって受信される。センサ５０及び／又はコンソールプロセッサ２２は、ＥＣＧ信号データを処理して、ディスプレイ３０上に心電図波形を生成することができる。センサ５０がＥＣＧ信号データを処理する場合、意図した機能を実行するためにセンサ５０の中にプロセッサが含まれる。コンソール２０がＥＣＧ信号データを処理する場合には、コンソール内のプロセッサ２２、コントローラ２４又は他のプロセッサを利用して、データを処理することができる。
[00028]このようにして、カテーテル７２が患者の脈管構造内を前進するのに応じて、ディスプレイ３０は、スタイレット１３０の電極によって検出されるような患者の心臓の電気的活動の結果として生成されるＥＣＧ心電図波形を表示する。より詳細には、その波形のＰ波部分を含む、ＳＡ結節のＥＣＧ電気的活動が、スタイレット１３０の電極によって検出され、センサ５０及びコンソール２０に転送される。その後、ＥＣＧ電気的活動は、ディスプレイ３０上に表示するために処理される。その際、カテーテルを配置する臨床医は、Ｐ波の表示を含むＥＣＧデータを観察し、カテーテル７２の遠位先端７６Ａが最適に配置されていること、例えば、一実施形態ではＳＡ結節に近いことを判断することができる。
[00029]スタイレット１３０の電極が患者の心臓のＳＡ結節に対して動かされるのに応じて、ＥＣＧ波形及びそのＰ波が変化することに留意されたい。例えば、電極がＳＡ結節に接近するのに応じて、ＥＣＧ波形のＰ波の振幅は一般的に増加することになり、電極がＳＡ結節から後退するのに応じて、一般的に減少することになる。上記のように、一実施形態では、コンソール２０は、スタイレット電極によって検出されたＥＣＧ信号を受信し、処理するために必要な、プロセッサ２２のような電子構成要素を含む。別の実施形態では、センサ５０は、ＥＣＧ信号を処理するために必要な電子構成要素を含むことができる。本明細書において記述されるカテーテル配置システムに関する更なる詳細及びその使用法は、２００９年９月１０日に出願され、「Apparatus and Display Methods Relating to Intravascular Placement of a Catheter」と題する米国特許出願公開第２０１０／００３６２２７号において入手することができ、参照によりその全体が本明細書に援用される。当然、上記のＥＣＧに基づくカテーテル配置システムは、本明細書において開示される実施形態を実践するために用いることができるＥＣＧモニタの一例にすぎない。実際には、他のＥＣＧに基づく監視及び配置システムを利用することもできる。
[00030]本実施形態におけるスタイレット１３０の電極は、導電性スタイレットワイヤの遠位部分を含み、そのスタイレットワイヤを介してＥＣＧ信号が検出され、テザー１３４及びセンサ５０に送信されるようになることに留意されたい。しかしながら、血管内ＥＣＧ信号を検出するために用いられる電極は数多くの異なる方法で構成できることに留意されたい。したがって、本明細書において用いられるときの「電極」は、患者の心臓からのＥＣＧ信号を検出するために用いることができる任意の構造を指すことができる。後に示されるように、他の実施形態における電極は、数ある実現可能な電極構成の中でも、カテーテルの内腔に配置される導電性溶液の液柱の一部を含むことができる。
[00031]更に上記のように、１つ又は複数のスタイレット電極が脈管構造内を前進するのに応じて、ＳＡ結節によって生成され、検出されたＥＣＧ信号の変化を観察することによって、カテーテルを配置している臨床医が、カテーテル７２の遠位先端が脈管構造内に所望のように位置決めされた時点を判断できるようになる。繰り返しになるが、望ましいカテーテル遠位先端位置の一例は、上大静脈（「ＳＶＣ」）下１／３内に配置することを含む。カテーテル７２の配置が完了した後に、スタイレット１３０はカテーテル７２の内腔から取り出され、そのカテーテルは初期の使用に備える。カテーテル７２の遠位先端７６Ａが患者の脈管構造内の所望の位置に最初に配置されるときに検出されるＥＣＧ波形は、本明細書において第１のＥＣＧ信号プロファイルとも呼ばれる。
[00032]不注意による遠位先端の位置異常又は変位を、確実に起こさないために、カテーテルを最初に配置した後の或る時点においてカテーテル遠位先端７６Ａの位置を再確認することが望ましい場合が多い。さらに、このことによって、カテーテルを介して患者に提供された薬剤又は他の溶液が脈管構造の所望の領域に確実に送達される。適切なカテーテル遠位先端位置の事後配置を再確認する際に、システム１０又は他の適切なＥＣＧ監視システムを用いることができる。
[00033]一実施形態では、カテーテル遠位先端配置のそのような再確認は、配置済みのカテーテルの遠位先端において、又はその近くにおいて、適切に配置された電極を介して検出されたＥＣＧ波形、本明細書において第２のＥＣＧ信号プロファイルとも呼ばれるＥＣＧ波形を測定し、その後、第２のＥＣＧプロファイルを、システム１０を用いてカテーテル７２が最初に配置されたときに取り込まれた第１のＥＣＧプロファイルと比較することによって達成することができる。
[00034]留置カテーテル遠位先端においてＥＣＧ信号を測定し、それにより第２のＥＣＧプロファイルを取得するために、カテーテル遠位先端に対するＥＣＧ信号を検出し、システム１０又は他の適切なＥＣＧモニタに送信できるようにする適切な導電性経路がカテーテル７２内に存在しなければならない。一実施形態では、カテーテル内に一時的に配置される導電性ワイヤが導電性媒体として用いられ、その遠位端がＥＣＧ信号を検出するための電極としての役割を果たす。導電性ワイヤは、ルアーコネクタ７４Ｃ及びそれぞれの延長脚部７４Ｂのうちの１つを通して挿入し、その後、カテーテル７２の内腔を通して遠位まで挿入することができる。配置済みのカテーテル７２の長さがわかると、そのワイヤは、その遠位端がカテーテルの遠位先端７６Ａに非常に近づくまで、又はカテーテルと同一の末端まで進められる。
[00035]カテーテル７２の近位端を越えて、ワイヤがその中を通って延在する延長脚部７４Ｂの外部に延在する導電性ワイヤの近位端は、図２のスタイレット１３０及びテザー１３４の近位端と同じようにして、システム１０に動作可能に接続される。この構成によれば、ＳＡ結節によって生成されたＥＣＧ信号、すなわち、第２のＥＣＧプロファイルを、導電性ワイヤの遠位端において、又はその近くにおいて検出し、導電性ワイヤを介してシステム１０に送信できるようになり、それにより、その現在の位置におけるカテーテル７２の遠位先端７６ＡのＥＣＧプロファイルに関して臨床医に知らせることができる。
[00036]上記のように、直前に論じられたように構成される導電性ワイヤは、図２に示されるスタイレット１３０に類似である。実際には、一実施形態において、現在の場所におけるカテーテル遠位先端の第２のＥＣＧプロファイルを取得することができるように、初期カテーテル配置のために用いられたスタイレット１３０を初期配置後に再び使用して、図２に示されるように、カテーテル７２の内腔に挿入し、テザー１３４を介してシステム１０に動作可能に接続することによって、カテーテル遠位先端場所を再確認することができる。さらに、別の適切なスタイレット又はガイドワイヤを用いて、カテーテル遠位先端からシステムまでの上記の導電性経路を設けることもできる。
[00037]図３は、先端位置再確認のために、留置カテーテル遠位端７６Ａにあるか、又はその近くにある電極と、システム１０との間に導電性経路を設けるための別の構成の詳細を示す。詳細には、その導電性経路は、カテーテルの遠位先端７６Ａまで延在するように、それぞれの延長脚部７４Ｂ、及びカテーテル７２の内腔内に配置される導電性溶液２００を含む。導電性溶液２００は、生理食塩水、又は他の生体適合性かつ導電性の溶液を含む。そのように構成されるとき、導電性溶液２００は、カテーテル７２の遠位先端７６ＡにおいてＥＣＧ信号を検出するための電極及び導電性経路の一部としての役割を果たす。それぞれの流体充填済みの延長脚部７４Ｂのルアーコネクタ７４Ｃにキャップ２０２が接続される。
[00038]導電性溶液２００に加えて、図３の実施形態の導電性経路は更に導電性ワイヤ２０８を含み、導電性ワイヤはキャップ２０２を通り抜け、その遠位端２０８Ｂが導電性溶液内に浸漬されるように、それぞれの延長脚部７４Ｂを通って遠位まで延在する。近位端２０８Ａにおいて終端する導電性ワイヤ２０８の近位部分はキャップ２０２から延在する。ワニ口クリップ２１０又は他の適切な電気コネクタが、導電性ワイヤ２０８の近位部分に取り付けられる。クリップ２１０はテザー２３４に動作可能に接続され、テザーは、図２のテザー１３４の接続と同じようにしてシステム１０のセンサ５０に接続し、それにより、カテーテル７２内に配置される導電性溶液２００の液柱をシステムに動作可能に接続し、導電性溶液によって検出されたＥＣＧ信号をシステムに送信できるようにする。このようにして、脈管構造内のカテーテル７２の遠位先端７６Ａの位置を表す第２のＥＣＧ信号プロファイルを取得することができる。図２及び図３との関連で説明された構成に加えて、他の実施形態では、他の導電性経路構成を利用できることに留意されたい。したがって、これらの導電性経路解決策は限定されないと見なされるべきである。
[00039]初期カテーテル遠位先端配置の時点において取得された第１のＥＣＧ信号プロファイルを遠位先端再確認の時点において測定された後続の第２のＥＣＧプロファイルと比較するために、初期配置の時点における第１のＥＣＧ信号プロファイルを記憶するための記憶構成要素が必要である。一実施形態では、これは、システム１０又は他の適切なＥＣＧモニタにカードリーダ／エンコーダ２５０を取り付けることによって成し遂げられ、コンソール２０に取り付けられた場合の一例が図４に示される。したがって、カテーテル７２がシステム１０を用いて最初に配置されるとき、カードをリーダ／エンコーダ２５０に通すことによって、システム１０によって患者データカード２５４を符号化することができ、リーダ／エンコーダは、データカードの磁気ストライプ２５６上に、初期配置の時点における第１のＥＣＧ信号プロファイルを含む、初期カテーテル配置に関する種々のデータを符号化し、記憶する。その後、カード２５４は患者に与えられるか、又は別の方法で保護される。
[00040]その後、以前に配置されたカテーテル７２（図１）の遠位先端７６Ａの位置を再確認することが望ましいとき、カテーテルは、図２、図３との関連で先に説明された構成のうちの１つにおいて、又はカテーテルの遠位先端７６Ａからシステムまでの導電性経路を設ける別の適切な方法によって、システム１０に動作可能に接続される。初期カテーテル配置の時点において符号化されたカード２５４は、その後、システム１０のリーダ／エンコーダ２５０に通され、それにより読み取られる。これにより、システム１０に、初期配置の時点におけるカテーテル遠位先端位置の第１のＥＣＧ信号プロファイルが与えられる。例えば、初期配置の時点においてカテーテル７２の遠位先端７６Ａにあるか、又はその近くにある電極によって検出されるようなＥＣＧ波形を含む、第１のＥＣＧ信号プロファイルは、システムコンソール２０（図１）のディスプレイ３０上に表示することができるか、又は別の方法で臨床医に伝達することができる。
[00041]その後、カテーテル７２の遠位先端７６Ａに、又はその近くに配置される電極と、電極をシステム１０とを相互接続する適切な導電性経路とを用いて、新たなＥＣＧ信号測定を行い、脈管構造内の現在のカテーテル遠位先端位置に関連する第２のＥＣＧ信号プロファイルを生成する。第２のＥＣＧ信号プロファイルも、第１のＥＣＧ信号プロファイルと同様に、システムコンソール２０のディスプレイ３０上に表示することができる。カテーテル７２の遠位先端７６Ａが望ましくない変位を受けたか否かを判断できるように、２つのＥＣＧ信号プロファイルをＥＣＧ波形として互いに重ね合わせて、或る適切な方法（例えば、Ｐ波絶対電圧値の測定値）において比較することができる。変位を受けていた場合には、カテーテル遠位先端７６Ａを適切に位置決めし直すために、臨床医によって適切な手順を始めることができる。変位を受けていなかった場合には、カテーテル７２を意図したように使用することができる。上記のプロセスの具体的な順序は、他の実施形態では異なる順序にできることに留意されたい。例えば、一実施形態では、第２のＥＣＧ信号プロファイルの取得は、第１のＥＣＧ信号プロファイルをシステムに入力する前に行うことができる。
[00042]図５は、初期配置の第１のＥＣＧ信号プロファイル及び他のデータを記憶し、アクセスできるようにするための別の実現可能な記憶構成要素を示しており、ＲＦＩＤチップ２７０が、分岐７４Ａのような、カテーテル７２自体の一部に埋め込まれる（図２も参照）。図６に示されるように、アンテナ２８０及び関連する回路２８２を含むＲＦＩＤエンコーダ／リーダ２７４をシステム１０又は他の適切なＥＣＧモニタに収容し、初期配置の時点におけるカテーテル遠位先端７６Ａの位置に関連する第１のＥＣＧ信号プロファイルを符号化し、カテーテルＲＦＩＤチップ２７０上に記憶できるようにする。一実施形態では、ＲＦＩＤチップ２７０は、チップ自体の固有識別情報用のリードオンリーメモリ、及び初期配置の時点における第１のＥＣＧ信号プロファイルを記憶するためにＲＦＩＤエンコーダ／リーダ２７４によってプログラム可能である不揮発性メモリの両方を含む、フィールドプログラマブルチップである。
[00043]第１のＥＣＧ信号プロファイルに加えて、患者氏名、初期配置の日付及び場所、トリミング後のカテーテルの最終的な長さ、以前の高圧注入の記録、クレアチニン又は他の血球計算等を含む、他のデータをＲＦＩＤチップ２７０（又は図４のカード２５４若しくは他の適切な記憶構成要素）上に記憶することができる。一実施形態では、配置が完了した後に挿入部位の外部に残るＰＩＣＣの部分の長さが記憶される。別の実施形態では、ユーザを有用な情報又は他の支援が提供されるウェブサイトに導くために、ウェブポータル情報を記憶することができる。ＲＦＩＤチップ２７０は能動チップ、受動チップのいずれであってもよいことに留意されたい。システム１０自体の内部の記憶場所、及びＥＣＧ信号モニタが、例えば、ＷｉＦｉ又は他の適切な無線プロトコルを介して無線でプロファイルにアクセスすることができる現地外の離れた記憶装置を含む、第１及び／又は第２のＥＣＧ信号プロファイルを記憶するための他の記憶構成要素も実現可能であることに更に留意されたい。
[00044]図７は、一実施形態による、カテーテル遠位先端位置の再確認中にシステム１０のディスプレイ３０上に示される画面表示３００の１つの取り得る例を示す。図に示されるように、画面表示３００は、上記の、初期カテーテル配置の時点における第１のＥＣＧ信号プロファイルに対応する波形３１０Ａ及び遠位先端配置の再確認の時点における第２のＥＣＧ信号プロファイルに対応する波形３１０Ｂを含むＥＣＧ波形３１０を示す。２つの波形３１０Ａ及び３１０Ｂは、システム１０によって較正し、一実施形態では、波形を比較できるように互いに重ね合わせることができる。一実施形態では、例えば、ＳＡ結節に対するカテーテル遠位先端７６Ａの変位が生じたか否かを判断できるように、初期波形３１０ＡのＰ波３１２Ａを現在の波形３１０ＢのＰ波３１２Ｂと比較することができる。
[00045]画面表示３００の右側は、患者、カテーテルタイプ、カテーテル長等に関する付加データ３１４も示す。当然、ＥＣＧ信号及び本明細書において示される他のデータは数多くの形式及び書式のうちの１つ又は複数をとることができる。実際には、当業者によって理解されるように、データの内容は、所望により、又は必要に応じて異なることができる。例えば、一実施形態では、初期カテーテル配置中のピークＰ波の大きさ、及び初期配置中に最終的に遠位先端を位置決めするためにカテーテルを引き戻した後のＰ波の大きさが、先端再確認の時点において取り込まれる同種の大きさと後に比較するために記憶される。
[00046]したがって、一実施形態によれば、患者の体内のカテーテル又は他の留置医療デバイスの位置を再確認するための方法が開示される。その方法は、患者のＥＣＧ信号を用いて患者の体内に医療デバイスを配置することと、その後、医療デバイスの初期配置が完了した後の留置医療デバイスの初期位置に関連する第１のＥＣＧ信号プロファイルを記憶することを含む。上記のように、第１のＥＣＧ信号プロファイルは、患者カード上、ＲＦＩＤチップ内、ＥＣＧ信号データを記録又は出力するシステムメモリ内、又は別の適切な記憶構成要素上に記憶することができる。その方法は更に、医療デバイスの初期配置後の或る時点において留置医療デバイスの位置に関連する第２のＥＣＧ信号プロファイルを取得することと、第１のＥＣＧ信号プロファイルを第２のＥＣＧ信号プロファイルと比較して、医療デバイスの初期配置後に留置医療デバイスの変位が生じたか否かを判断することとを含む。プロファイルを比較することは、臨床医がコンソールディスプレイ３０上に表示される波形を観察することによって直接実行することができること、又はコンソール２０のプロセッサ２２によって実行可能な適切なアルゴリズムによって自動的に実行できることに留意されたい。
[00047]本発明の実施形態は、本開示の精神から逸脱することなく他の特定の形において具現することができる。上記の実施形態は、あらゆる面において、制限するものではなく、単なる例示と見なされるべきである。それゆえ、実施形態の範囲は、これまでの説明によってではなく、添付の特許請求の範囲によって示される。特許請求の範囲の意味及び等価物の範囲内に入る全ての変更は特許請求の範囲内に含まれるものとする。

Claims (13)

  1. 患者のカテーテルの位置を再確認するためのシステムであって、前記カテーテルが前記患者の心臓のＥＣＧ信号生成結節の近くに配置され、前記システムが、
    第１のＥＣＧ信号プロファイルを取得するための少なくとも１つの電極であって、前記第１のＥＣＧ信号プロファイルが前記患者内の前記カテーテルの遠位先端の初期位置に関連し、前記少なくとも１つの電極が前記患者内の前記カテーテルの前記遠位先端のその後の位置に関連する第２のＥＣＧ信号プロファイルも取得する、少なくとも１つの電極と、
    少なくとも前記第１のＥＣＧ信号プロファイルを記憶するための記憶構成要素と、
    前記記憶構成要素から前記第１のＥＣＧ信号プロファイルを受信し、かつ前記第２のＥＣＧ信号プロファイルも受信するＥＣＧ信号モニタであって、前記カテーテルの前記遠位先端の前記その後の位置が前記初期位置と異なるか否かを判断できるように、第１のＥＣＧ信号プロファイル及び第２のＥＣＧ信号プロファイルに関連するデータを伝達するＥＣＧ信号モニタと
    を備える、再確認するためのシステム。
  2. 前記第１のＥＣＧ信号プロファイルを取得するための前記少なくとも１つの電極が、前記患者の前記体内にある前記カテーテルに収容され、前記少なくとも１つの電極が導電性経路によって前記ＥＣＧ信号モニタに動作可能に接続される、請求項１に記載の再確認するためのシステム。
  3. 前記少なくとも１つの電極が前記カテーテルの内腔内に配置されるスタイレットを含み、前記導電性経路が前記少なくとも１つの電極に動作可能に接続されるテザーを含む、請求項２に記載の再確認するためのシステム。
  4. 前記少なくとも１つの電極及び導電性経路が、前記カテーテルの内腔内に配置される導電性溶液を含む、請求項１に記載の再確認するためのシステム。
  5. 前記導電性溶液内に導電性ワイヤが部分的に配置され、前記導電性ワイヤが、前記カテーテルから延在し、前記ＥＣＧ信号モニタに動作可能に接続される、請求項４に記載の再確認するためのシステム。
  6. 前記記憶構成要素が前記カテーテル内に収容されるＲＦＩＤチップを含み、前記ＥＣＧ信号モニタが、前記ＲＦＩＤチップの前記第１のＥＣＧ信号プロファイルを符号化し、かつ読み取るためのＲＦＩＤエンコーダ／リーダを含む、請求項１に記載の再確認するためのシステム。
  7. 前記ＲＦＩＤチップがフィールドプログラマブルチップである、請求項６に記載の再確認するためのシステム。
  8. 前記記憶構成要素が前記カテーテルに対して離れて配置される、請求項１に記載の再確認するためのシステム。
  9. 前記記憶構成要素がプログラマブル磁気ストライプを含むカードを含み、前記ＥＣＧ信号モニタがカードエンコーダ／リーダを含む、請求項８に記載の再確認するためのシステム。
  10. 前記ＥＣＧ信号モニタが、前記第１のＥＣＧ信号プロファイルを離れた場所から無線で受信する、請求項１に記載の再確認するためのシステム。
  11. 前記第１のＥＣＧ信号プロファイル及び前記第２のＥＣＧ信号プロファイルのうちの少なくとも一方が、配置後に前記患者の前記体の外部に残る前記カテーテルの部分の長さ、及び更なる情報を入手することができるウェブポータルのうちの少なくとも一方に関連するデータを含む、請求項１に記載の再確認するためのシステム。
  12. 前記ＥＣＧ信号モニタが、前記患者の内部に配置される少なくとも１つの電極と、前記患者の皮膚に配置するための少なくとも２つの電極とを含む、請求項１に記載の再確認するためのシステム。
  13. 前記第１のＥＣＧ信号プロファイルを取得する際に第１の電極が利用され、前記第２のＥＣＧ信号プロファイルを取得する際に第２の電極が利用される、請求項１に記載の再確認するためのシステム。
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US20150080716A1 (en) 2015-03-19
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MX338127B (es) 2016-04-04
EP2605699A2 (en) 2013-06-26
MX2013001317A (es) 2013-03-18
US10046139B2 (en) 2018-08-14
EP2605699A4 (en) 2015-01-07
BR112013002431B1 (pt) 2021-06-29
KR20130124298A (ko) 2013-11-13
WO2012024577A3 (en) 2013-09-06
CN103442632A (zh) 2013-12-11
US20120046562A1 (en) 2012-02-23
WO2012024577A2 (en) 2012-02-23

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