JP5507539B2 - 換気回路アダプターおよび近位エアロゾル送達システム - Google Patents
換気回路アダプターおよび近位エアロゾル送達システム Download PDFInfo
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- JP5507539B2 JP5507539B2 JP2011500899A JP2011500899A JP5507539B2 JP 5507539 B2 JP5507539 B2 JP 5507539B2 JP 2011500899 A JP2011500899 A JP 2011500899A JP 2011500899 A JP2011500899 A JP 2011500899A JP 5507539 B2 JP5507539 B2 JP 5507539B2
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Description
本出願は2008年3月17日付けで米国で出願された「VENTILATION CIRCUIT ADAPTOR」と題する仮特許出願第61/069,850号および「CIRCUIT ADAPTOR AND PROXIMAL AEROSOL DELIVERY SYSTEM」と題する仮特許出願第61/076,442号の権利を主張するものであり、この参照によってそれらの全体が本明細書に組み込まれるものである。
この実験計画(プロトコル)は、CPAPを用いた3つの異なる換気回路アダプターのエアロゾル希釈効果の特性を明らかにするように設計されている:a)Nivenらの米国特許出願公開第2006/120968号に開示されたアダプター(アダプター1)、b)'高い抵抗アダプター'(図1A、2A〜4に記載された、10mmエアロゾルフローチューブ(図2BのL1)のアダプター2)、およびc)'低い抵抗アダプター'(図1A、2A〜4に記載された、5〜6mmエアロゾルフローチューブ(図2BのL1)のアダプター3)。エアロゾル希釈を測定するため、2つの異なる濃度の酸素を有するガスが使用された:エアロゾル流用の100%酸素ガスおよびCPAP流用の21%酸素ガス。前記アダプターは、異なるCPAP流の状態(6、8、10、および12L/min)、異なる定常状態、見込み吸気流(0.3、1.04、3.22、および5.17L/min)の下でテストされた。前記エアロゾル流は、一定の3L/minであり、前記CPAP圧力は、全てのテスト状態で5cm H2Oを維持した。
この研究の目的は、'Y'コネクタにおけるCPAP換気回路の中へのエアロゾル導入に使用される異なる換気回路アダプターの運転特性を評価するためである。運転特性は、潜在的標的である新生児集団に対する典型的な換気状態の下でテストされた異なるアダプターの抵抗値を基に評価される。
未熟仔羊の前臨床試験は、RDSを予防する吸気用エアロゾルルシナクタント(肺サーファクタント製剤)の効力を提供することを目指し、図1A、2Aに示された本発明の換気回路アダプターの実施形態を利用した。妊娠126〜128日の4頭の仔羊が、早期産後CPAPを使用して治療された。出生後30分以内に、前記エアロゾル界面活性剤処理が開始された。前記アダプターは、気に留まるような有害事象もなく前記動物にエアロゾルを効果的に送達した。
Claims (20)
- 同時陽圧換気を使用して患者にエアロゾル活性薬剤を送達するためのアダプターであって、
患者インターフェイスポートと、エアロゾルフローチャネルと、エアロゾルフローチャンバーと、エアロゾル流路と、換気ガス流路と、換気ガスフローチャンバーとを備え、
前記エアロゾルフローチャンバーは、内壁面を有する壁部を有し、このエアロゾルフローチャンバーは長手方向に沿ってこのエアロゾルフローチャンバーの一端に位置するエアロゾル吸気ポートからこのエアロゾルフローチャンバーの他端に位置する患者インタフェースポートに亘って伸びるものであり、
前記エアロゾルフローチャネルは、エアロゾルフローチャンバー内に位置し、このエアロゾルフローチャンバーは長手方向に沿う軸を有し、この軸は前記前記エアロゾルフローチャンバーの軸と同軸であり、前記エアロゾルフローチャンネルは内壁面と外壁面を有する前記エアロゾルフローチャンネル吸気ポートからエアロゾルフローチャンネル排気ポートへと伸びる壁部を有し、ここで、前記エアロゾルフローチャンネル排気ポートは、前記エアロゾルフローチャンバーの長手方向に沿って奥まって位置しており、ここで、前記エアロゾルフローチャンネル吸気ポートは気密連続的に前記エアロゾルフローチャンバーの内壁面に接続されており、ここで、前記エアロゾルフローチャンネル排気ポートにおけるエアロゾルフローチャンネルの横断領域(壁部を含む部分)の面積は、前記患者インタフェースフェースポートにおけるエアロゾルフローチャンバーの横断領域の面積よりも小さく、それにより前記エアロゾルフローチャンネルの前記外壁面とエアロゾルフローチャンバーの内壁面によって区画された環状領域を提供し、この環状領域は前記患者インタフェースポートと流体連通しており、これにより、前記エアロゾル流路は前記エアロゾル吸気ポートから前記エアロゾルフローチャンネル内を通って前記患者インタフェースポートに出るように構成されており、
前記換気ガスフローチャンバーは、換気ガス吸気ポートから前記エアロゾルフローチャンバーの前記壁部を通り、前記環状領域を通過すると共にこれにより前記患者インタフェースポートと流体連通し、そして、前記エアロゾルフローチャンバー内の前記壁部を通って前記換気ガス排気ポートへ至り、それにより、前記換気ガス流路は前記換気ガス吸気ポートから前記環状領域を通って換気ガス排気ポートへ延長されたものである
ことを特徴とするアダプター。 - 請求項1記載のアダプターにおいて、このアダプターは、さらに、
前記エアロゾル吸気ポートにバルブを有するものである、アダプター。 - 請求項2記載のアダプターにおいて、前記バルブは、陽圧換気を維持しながら、器具、カテーテル、チューブ、またはファイバーのうちの少なくとも1つを前記エアロゾルフローチャネルおよび前記患者インターフェイスポートの少なくとも1つの中へおよび経由させて導入することを可能にするのに十分な可撓性を有するものである、アダプター。
- 請求項1記載のアダプターにおいて、前記エアロゾルフローチャネルは直線エアロゾル流路、曲線状エアロゾル流路、または角度を有するエアロゾル流路を定義するものである、アダプター。
- 請求項1記載のアダプターにおいて、前記エアロゾルフローチャネルは均一の断面積を有するものである、アダプター。
- 請求項1記載のアダプターにおいて、前記エアロゾルフローチャネルの前記エアロゾル吸気ポートは、前記患者インターフェイスポートより大きい断面積を有するものである、アダプター。
- 請求項1記載のアダプターにおいて、前記換気ガスフローチャネルは、
前記エアロゾルフローチャネルは前記換気ガス吸気ポートからの前記換気チャンバーへのガスの入口よりも下方に且つ前記換気チャンバーからの前記換気ガス排気ポートへのガスの出口よりも下方に延長するような十分な長さである、アダプター。 - 請求項7記載のアダプターにおいて、前記エアロゾル排気ポートは前記患者インターフェイスポートから少なくとも8ミリメートル奥に位置するものである、アダプター。
- 請求項7記載のアダプターにおいて、前記チャンバーは、前記エアロゾル排気ポートと前記患者インターフェイスポートとの間に少なくとも1.4ミリリットルの容積を有するものである、アダプター。
- 請求項7記載のアダプターにおいて、このアダプターは、さらに、
前記エアロゾル排気ポートに一方向バルブを有するものである、アダプター。 - 同時陽圧換気を使用して推進エアロゾル活性薬剤を患者に送達するシステムであって、
a)加圧換気ガスを生成する陽圧発生装置と、前記加圧換気ガスを前記患者に送達する第1の送達導管と、前記患者からの呼気ガス流を誘導する第2の送達導管とを有する陽圧換気回路と、
b)エアロゾル活性薬剤を生成する前記エアロゾル発生装置と、
c)前記換気ガスおよび前記エアロゾル活性薬剤を前記患者に送達する患者インターフェイスと、
d)前記陽圧換気回路、前記エアロゾル発生装置、および前記患者インターフェイスに連通するアダプターであって、このアダプターは、
(i) 患者インターフェイスポートと、エアロゾルフローチャネルと、換気ガスフローチャネルとを備え、
(ii) 前記エアロゾルフローチャネルは、長手方向に沿う軸を有し、この軸の長さ方向に沿う両端部にそれぞれエアロゾル吸気ポートとエアロゾル排気ポートとを有し、前記エアロゾル吸気ポートから前記エアロゾル排気ポートまでに亘る全長を有し、このエアロゾルフローチャネルの全長に沿ったエアロゾルの流れを包囲し前記長手方向に沿う軸に沿って導くように構成されたものであり、かつこのエアロゾルフローチャンネルの前記エアロゾル排気ポートは前記患者インターフェイスポートと流体流通しているか、若しくは前記エアロゾル排気ポートはこの患者インタフェイスポートと一体的に構成されているものであり、
(iii) 前記換気ガスフローチャネルは、長手方向に沿う軸を有し、この軸の長さ方向に沿う両端部にそれぞれ換気ガス吸気ポートと換気ガス排気ポートとを有し、前記換気ガス吸気ポートから換気ガス排気ポートへ前記長手方向に沿う軸に沿って換気ガスの流れを通過させるように構成されるものであり、
(iv) 前記患者インターフェイスポートは、前記換気ガスフローチャネルの前記長手方向に沿う軸に沿った一部分でこの換気ガスフローチャネルと流体連通するように構成されており、
(v) 前記換気ガスフローチャネルと前記エアロゾルフローチャネルは、互いの長手方向に沿う軸を離間させ、かつ前記換気ガスフローチャンネルが前記エアロゾルフローチャネルの周囲をこのエアロゾルフローチャネルの長手方向に沿う軸周りに部分的又は完全に取り囲むように、互いに分離されて設けられているものである
アダプターと、
e)前記エアロゾル発生装置と連通して、前記推進エアロゾル活性薬剤を生成するようになっているエアロゾル・エントレインメント・チャンバーと、
f)前記第1の送達導管と連通する、前記加圧換気ガスを前記患者に送達する補助回路であって、前記第1の送達導管および前記エアロゾル・エントレインメント・チャンバーに接続する第1の補助導管と、選択的に、前記エアロゾル・エントレインメント・チャンバーと前記アダプターを接続する第2の補助導管とを有するものである、前記補助回路と
を有し、
前記第1の補助導管は、推進エアロゾル活性薬剤の送達のためのシースガスとして使用されるため前記アダプターへ向けられた前記加圧換気ガスの主流から取り出された前記加圧換気ガスの一部を収容し、且つ、当該加圧換気ガスの一部を前記エアロゾル・エントレインメント・チャンバーに送達するようになっているものであり、これにより前記エアロゾル活性薬剤と結合して前記推進エアロゾル活性薬剤を形成するものであることを特徴とするシステム。 - 請求項11記載のシステムにおいて、前記換気ガスフローチャネルは、前記ガス吸気ポートと前記ガス排気ポートと前記患者インターフェイスポートとを含むチャンバーを形成するものであり、前記エアロゾルフローチャネルは、前記チャンバー内に入れ子にされ、且つ前記チャンバーの一端の前記エアロゾル吸気ポートから前記チャンバーを経由して前記チャンバー内の前記エアロゾル排気ポートまで延長しており、これにより前記エアロゾル排気ポートが前記チャンバーの反対端の前記患者インターフェイスポートより奥に位置するものであり、前記エアロゾルフローチャネルは、前記ガス吸気ポートから前記チャンバーへのガスの入口の下方に、且つ前記チャンバーから前記ガス排気ポートへのガスの出口の下方に延出する十分な長さのものである、システム。
- 請求項12記載のシステムにおいて、前記アダプターは、前記エアロゾル吸気ポートにバルブをさらに有するものである、システム。
- 請求項11記載のシステムにおいて、前記エアロゾル・エントレインメント・チャンバーは、前記アダプターの前記エアロゾル吸気ポートに直接連結するものである、システム。
- 請求項11記載のシステムにおいて、前記補助回路は、前記患者の最大吸気流に基づいて前記加圧換気ガスの一部を量り分けるコネクタを有するものである、システム。
- 請求項11記載のシステムにおいて、前記補助回路は、さらに、前記シースガスの流れを制御する流量制限器を有するものであり、これにより前記シースガスの流れは前記患者の最大吸気流と同じか又はそれよりも高くなるものである、システム。
- 請求項11記載のシステムにおいて、第2の補助導管は、前記エアロゾル・エントレインメント・チャンバーと前記アダプターのエアロゾル吸気ポートとを連結するために追加されたものである、システム。
- 請求項1記載のアダプターにおいて、前記エアロゾルフローチャンネル吸気ポートは、漏斗形状のフランジを介して前記エアロゾルフローチャンバーの内壁面と連続的に接続されているものである、アダプター。
- 請求項1記載のアダプターにおいて、前記エアロゾルフローチャンネル吸気ポートは、このエアロゾルフローチャンバの長手方向軸と直行する方向に延びるフランジを介して前記エアロゾルフローチャンバーの内壁面と連続的に接続されているものである、アダプター。
- 請求項1記載のアダプターにおいて、前記エアロゾルフローチャンネル吸気ポートは、前記エアロゾルフローチャンバーの長手方向に沿って奥まって位置している、アダプター。
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