JP6334524B2 - 神経外科用の器具および方法 - Google Patents
神経外科用の器具および方法 Download PDFInfo
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- JP6334524B2 JP6334524B2 JP2015523612A JP2015523612A JP6334524B2 JP 6334524 B2 JP6334524 B2 JP 6334524B2 JP 2015523612 A JP2015523612 A JP 2015523612A JP 2015523612 A JP2015523612 A JP 2015523612A JP 6334524 B2 JP6334524 B2 JP 6334524B2
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Classifications
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- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
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- A61M25/0029—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports
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- A61B17/3403—Needle locating or guiding means
- A61B2017/3405—Needle locating or guiding means using mechanical guide means
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- A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
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- A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
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- A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
- A61M2025/0006—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system which can be secured against axial movement, e.g. by using a locking cuff
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- A61M25/00—Catheters; Hollow probes
- A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
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- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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Landscapes
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- Media Introduction/Drainage Providing Device (AREA)
- Control Of Motors That Do Not Use Commutators (AREA)
- Inorganic Insulating Materials (AREA)
- Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
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- Surgical Instruments (AREA)
Description
(本明細書では「くぼみを設けられたカテーテル」と称される)本発明による神経用器具が、1mmの段を設けられたカテーテルとセラミックの0.6mmの段を設けられたカテーテルと比較された。各カテーテルの設計は、それらが、それらの遠位の段を設けられた外径を越えて延在する(外径0.23mm、内径0.15mmの)融解石英の3mmの長さをそれぞれ有するという点で類似していた。1mmの段を設けられたカテーテルは、くぼみを除いて、くぼみを設けられたカテーテルと同じ外側プロファイルを有した。セラミックカテーテルは、0.23mmから0.6mmの間の遠位段を有した。器具は、脳灰白質と同じ細孔比を有するアガロースゲル(0.5%)脳モデルで評価された。くぼみを設けられたカテーテルは、その後に、大型動物モデルである、大型の白色ランドレース種のブタで評価された。
材料および方法
くぼみを設けられたカテーテルのカーボタンガイド管2は、80mmの長さに切断され、留置カテーテル1は、融解石英先端11(外径0.23mm/内径0.15mm)がその末端エンド内に接着されそれがそこから6mm突出した、PEEK管(外径0.6mm/内径0.25mm)であった。止め具7は、PEEK管のその末端エンドから77mmのところに適用され、したがって、それがガイド管2に挿入されるとき、3mmのくぼみが作り出され、融解石英先端11は、その中心軸の下の方へ横切り、ガイド管2の末端エンドを越えて3mm延在していた。
くぼみを設けられた段カテーテルと段を設けられたカテーテルとの間の分配体積を比較した結果は、図7、8に示されている。
典型的には、くぼみを設けられたカテーテルと1mm段カテーテルの両方について、注入の開始のときに、融解石英の先端で小さな球状の分配体積が見られた。その後、段の方に向かって近位に延在するミクロの逆流が見えるようになった。球状の形状は、次いで、広がって進化して滴になった。通常、増加段階の終わりで通常起こる、滴の頂点が段まで延在すると、そのころには各カテーテルの性能が違っていた。
くぼみを設けられたカテーテルは、それをブタの被殻に左右相称に埋め込むことによって評価され、その性能は、やはりまたそのブタの被殻に埋め込まれた1mmの段を設けられたカテーテルと比較された。
本研究では、45kgのオスの大型の白色ランドレース種のブタ2頭が使用された。研究は、適切なプロジェクトライセンスおよび個人ライセンスのもと、英国科学的処置法(UK scientific procedures act)1986に従って実施された。動物は、培養された筋肉内ケタミン(10mg/kg)によって鎮静され、その後、1.5〜5%イソフルランで麻酔がかけられた。
くぼみを設けられたカテーテルは、合併症も起こさずに導入され、画像分析は、時間とともに分配体積の直線的な増加(Vd/Vi≒2.75)を示した。各カテーテルに587.5μlを注入した後には逆流は識別されず、そのときまでの各カテーテルからの分配体積は、約1500mm3であり、被殻はコントラストで埋め尽くされていた。実験は、さらなる有用な情報が得られなかったのでこの時点で終了された。カテーテルは除去され、創傷が閉じられ、麻酔が逆転された。ブタは、何らの神経障害を検出されることなく回復した。結果は、図11に図表的に示されている。
Claims (22)
- カテーテルとガイド管とを備える神経用キットであって、前記カテーテルは、流体を脳内のターゲット部位に送達する1または複数のポートを持った末端エンドを有するチュービングの末端部分を備え、前記チュービングの末端部分は、前記ガイド管の内径よりも小さい外径を有し、および、前記カテーテルおよび前記ガイド管は、前記ターゲット部位に前記1または複数のポートが配置されるように前記カテーテルが前記ガイド管に挿入されたときに、前記ガイド管と前記カテーテルの前記チュービングの末端部分との間の前記ガイド管の末端エンド部分内にくぼみが設けられるように構成されることを特徴とする、神経用キット。
- 前記ガイド管内に挿入されるべき前記カテーテルの限度を示す指示であって、使用のときに前記1または複数のポートを前記脳内の前記ターゲット部位に配置する指示を備え、前記カテーテルおよび前記ガイド管は、前記カテーテルが前記指示によって示される前記限度まで前記ガイド管に挿入されたときに、前記ガイド管と前記カテーテルの前記チュービングの末端部分との間の前記ガイド管の前記末端エンド部分内に前記くぼみが設けられるように構成されることを特徴とする、請求項1に記載の神経用キット。
- 前記指示は、前記カテーテル上に配置される止め具と、前記止め具によって係合されて前記カテーテルが前記ガイド管に挿入され得る限度を画定する前記ガイド管上の形成物とを備えることを特徴とする、請求項2に記載の神経用キット。
- 前記指示は、前記カテーテル上のしるしであり、前記ガイド管への前記カテーテルの挿入の間に指定された位置で整列されるとき、前記1または複数のポートが前記ターゲット部位に配置されている前記カテーテルの位置を識別することを特徴とする、請求項2に記載の神経用キット。
- 前記くぼみは、前記カテーテルを使用して送達された流体の前記ガイド管に沿った逆流に対するシールとして働くのに十分な体積の脳組織を保持するように寸法設定されることを特徴とする、請求項2乃至4のいずれか一項に記載の神経用キット。
- 前記くぼみは、前記ガイド管内に少なくとも0.5mm延在することを特徴とする、請求項2乃至5のいずれか一項に記載の神経用キット。
- 前記くぼみは、前記ガイド管内に約3mm延在することを特徴とする、請求項6に記載の神経用キット。
- 前記くぼみを画定する前記カテーテルの前記末端部分の前記外径よりも大きな外径と前記くぼみを画定する前記ガイド管の前記内径よりも小さな内径とを有するチュービングの延伸部であって、前記チュービングの延伸部の末端エンドが前記ガイド管の末端エンドから間隔を置かれるかたちで前記ガイド管内に配置されるまたは配置可能な、チュービングの延伸部を備えることを特徴とする、請求項2乃至7のいずれか一項に記載の神経用キット。
- 前記チュービングの延伸部は、前記カテーテルの中間部分であり、前記カテーテルは、前記カテーテルの前記末端部分から中間部分に向けて増加する外径を備えることを特徴とする、請求項8に記載の神経用キット。
- 前記内径の増加は、前記カテーテルの前記中間部分と前記末端部分との間の段であることを特徴とする、請求項9に記載の神経用キット。
- 前記外径の増加は、前記カテーテルの前記末端部分から前記中間部分に向けてのゆるやかな増加であることを特徴とする、請求項9に記載の神経用キット。
- 前記カテーテルの前記末端部分は、堅い無孔の先端を備えることを特徴とする、請求項2乃至11のいずれか一項に記載の神経用キット。
- 前記カテーテルは、前記堅い無孔の先端に通じる可撓性管を備え、前記可撓性管は、前記堅い無孔の先端の直径よりも大きな直径を有することを特徴とする、請求項12に記載の神経用キット。
- 前記ガイド管の内径は、前記末端エンド部分と中間部分との間で減少することを特徴とする、請求項2乃至7のいずれか一項に記載の神経用キット。
- 前記内径の減少は、前記ガイド管の前記中間部分と前記末端エンド部分との間の段であることを特徴とする、請求項14に記載の神経用キット。
- 前記内径の減少は、前記ガイド管の前記末端エンド部分から前記中間部分に向けたゆるやかな減少であることを特徴とする、請求項14に記載の神経用キット。
- 前記ガイド管の中間部分の内径および前記カテーテルの中間部分の外径は、前記カテーテルの前記中間部分が、前記ガイド管の前記中間部分内に滑り嵌めするようになっていることを特徴とする、請求項2乃至16のいずれか一項に記載の神経用キット。
- 前記カテーテルの前記中間部分は、前記カテーテルが前記指示によって示される前記限度まで前記ガイド管に挿入されるとき、前記ガイド管の前記末端エンドが前記カテーテルが初めて前記ガイド管に係合する接触面から少なくとも0.5mmに配置されるように、位置決めされることを特徴とする、請求項17に記載の神経用キット。
- 前記チュービングの延伸部は、前記ガイド管および前記カテーテルとは別個のさらなるチュービングであり、前記さらなるチュービングは、前記カテーテルが前記さらなるチュービングの全長にわたって延在するかたちで前記カテーテルを受容し、前記さらなる管の末端エンドが前記ガイド管から間隔を置かれその中に含まれるように前記ガイド管内に受容されるように構成されることを特徴とする、請求項8に記載の神経用キット。
- 脳内のターゲット部位に流体を送達する1または複数のポートを持つ末端エンドを有するチュービングの末端部分を備えるカテーテルであって前記1または複数のポートが前記脳内の前記ターゲット部位に配置されるようにガイド管内に受容されるカテーテルを備える神経用デバイスであって、前記チュービングの末端部分は、前記ガイド管の内径よりも小さい外径を有し、前記ガイド管と前記カテーテルの前記チュービングの末端部分との間の前記ガイド管の末端エンド部分内にくぼみを設けるように配置されることを特徴とする神経用デバイス。
- 前記くぼみは、押し付けられた脳組織を含むことを特徴とする、請求項20に記載の神経用デバイス。
- 所望の長さに切断され得るガイド管と、脳内のターゲット部位に流体を送達する1または複数のポートを持つ末端エンドを有するチュービングの末端部分であって前記ガイド管の内径よりも小さい外径を有する前記チュービングの末端部分を備えるカテーテルと、前記ガイド管に挿入されるべき前記カテーテルの限度を示し、使用のとき、前記脳内の前記ターゲット部位に前記1または複数のポートを配置し、前記ガイド管と前記カテーテルの前記チュービングの前記末端部分との間の前記ガイド管の末端エンド部分内にくぼみを形成する指示とを備え、前記指示は前記カテーテルの長さに沿って調節可能であることを特徴とする神経用キット。
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EP2877108A1 (en) | 2015-06-03 |
US20200324089A1 (en) | 2020-10-15 |
CN104582610B (zh) | 2018-03-20 |
US20240181223A1 (en) | 2024-06-06 |
US20150165166A1 (en) | 2015-06-18 |
US10751513B2 (en) | 2020-08-25 |
CA2879770C (en) | 2021-03-02 |
EP2877108B1 (en) | 2023-06-07 |
WO2014016591A1 (en) | 2014-01-30 |
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