JP2022511792A - 手術室用コーティングアプリケータ及び手術室用コーティングの方法 - Google Patents
手術室用コーティングアプリケータ及び手術室用コーティングの方法 Download PDFInfo
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- JP2022511792A JP2022511792A JP2021530895A JP2021530895A JP2022511792A JP 2022511792 A JP2022511792 A JP 2022511792A JP 2021530895 A JP2021530895 A JP 2021530895A JP 2021530895 A JP2021530895 A JP 2021530895A JP 2022511792 A JP2022511792 A JP 2022511792A
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Abstract
Description
本出願は、2018年11月29日出願の米国仮特許出願第62/773,102号に基づく利益を主張するものであり、その内容は全ての目的のためにその全体が参照により本明細書に組み込まれる。
本開示は、概して、物体に治療薬をコーティングするための装置及び方法に関し、より具体的には、手術を行う過程で外科用器具又は外科用インプラントに治療薬をコーティングするために手術室で使用するのに好適な装置及び方法に関する。
米国では、毎年、約2700万件の外科手術が行われる。術後又は手術部位感染(「SSI」)は、全事例のうちの約2~3%に生じている。この率は、毎年、675,000件を超えるSSIの発生に相当する。
デバイス区画15を開放するステップと、
コーティングされる物体22をデバイス支持プラットフォーム20上に置くステップと、
デバイス区画15のそれぞれの蓋(14、50)を閉じるステップと、
真空蓋14をベース16に封止するステップと、
デバイス区画15の内部を排気するために、デバイス区画15内で真空を約2~3分間吸引し、治療薬を気化させるために、熱源18を作動させるステップと、
真空を解放するステップと、
ベース16から真空蓋を除去するステップと、
デバイス区画15を開放するステップと、
コーティングされた物体を除去するステップと、
を含む。
ディスペンサ312からパケット310及びアクセサリ116を取り外し、そのパケット310からデバイス区画バッグ112を除去するステップであって、除去は手術室の滅菌野内で実施されてもよい(図7A、図7B参照)、ステップと、
手術室の滅菌野でデバイス区画バッグ112を開放し、コーティングされる物体22(医療用デバイスなど)をデバイス区画バッグ112に挿入するステップ(図7C参照)と、
デバイス区画バッグ112を閉じ、再封止するステップ(これは滅菌野で行われてもよい)ステップ(図7D参照)と、
封止されたデバイス区画バッグ112を、滅菌野の外にあってもよいアクセサリユニット116の位置に移す(図7E参照)ステップと、
封止されたデバイス区画バッグ112のアダプタ150をアクセサリユニット116のアダプタ152に一時的に取り付け、アダプタ152を作動させて、以下を含み得るコーティングサイクルを実行する(図7F、図7G参照)ステップと、
真空を吸引し、熱源を封止されたデバイス区画バッグ112内で所望の時間加熱して、デバイス区画バッグ112内の治療薬を気化させ、物体22をコーティングするステップと、
真空を解放するステップと、
を実施することによって実施され得る。
封止されたバッグ112内のコーティングされた物体22を手術室の滅菌野に移す。
デバイス区画バッグ112を開放し、滅菌野内で、コーティングされた物体22をバッグ112から除去する(図7H参照)。
インプラントは、スタンドオフメッシュ212によって熱源202から部分的に熱的に絶縁されており、また、プロセスが急速に発生し、インプラントの熱質量が加熱要素の熱質量に対して大きいという事実によって、熱源とインプラントとの間の熱平衡は決して起こらない。その結果、インプラントは通常、熱源よりも著しく低温になる。インプラントなどの医療用デバイスにトリクロサンをコーティングするように設計されたコーティングデバイスでは、温度差(又は温度勾配)は約50℃~約150℃になり得る。このように、インプラントの比較的冷たい表面に高温の蒸気を凝縮させるための非常に大きな熱力学的駆動力が存在する。これにより、さもなくば活性剤が好ましく吸収されないような様々な表面に活性剤を凝縮させることができる。したがって、現在開示されているデバイス及び方法は、Scalzoらよる米国公開特許出願第2004/0220614号に開示されているような、トリクロサンを含浸させた吸収性縫合糸を作製するために使用される以前のプロセスとは著しく異なる。
本明細書に開示されるシステム及び方法は、医療用デバイス産業に適用可能である。
(1) 治療薬のコーティングを適用するためのコーティング装置であって、
開放可能かつ封止可能なデバイス区画と、
前記デバイス区画と連通するように位置付けられた治療薬と、
前記治療薬を気化させるための熱源と、
前記デバイス区画と流体連通している真空源と、
を備える、コーティング装置。
(2) 前記デバイス区画は剛性壁を有する、実施態様1に記載のコーティング装置。
(3) 前記デバイス区画はベースに接続され、前記ベースは前記真空源を組み込んでいる、実施態様2に記載のコーティング装置。
(4) 前記デバイス区画は、前記ベースに取り外し可能かつ封止可能に連結されており、前記ベースと前記デバイス区画との間に電気的接続部及び真空接続部が延びている、実施態様3に記載のコーティング装置。
(5) 前記治療薬は担体に取り込まれる、実施態様1に記載のコーティング装置。
(7) 前記吸収性ポリマーは、ラクチドグリコリドコポリマーである、実施態様6に記載のコーティング装置。
(8) 前記担体は、前記熱源に隣接して位置付けられる、実施態様5に記載のコーティング装置。
(9) 前記治療薬はトリクロサンである、実施態様1に記載のコーティング装置。
(10) 前記デバイス区画は、可撓性側面を有する、実施態様1に記載のコーティング装置。
(12) 前記デバイス区画の前記側面と前記熱源との間に熱絶縁を提供するために、前記熱源の上方の前記デバイス区画内に位置付けられた第1のスペーサメッシュと、前記デバイス区画の前記側面と前記熱源との間に位置付けられた第2のスペーサメッシュと、を更に備える、実施態様11に記載のコーティング装置。
(13) 前記治療薬は、前記第1のスペーサメッシュ上にコーティングされる、実施態様12に記載のコーティング装置。
(14) 前記治療薬は、前記熱源上にコーティングされる、実施態様12に記載のコーティング装置。
(15) 前記治療薬は、前記熱源に隣接して配置された担体上に又は前記担体内に装填される、実施態様12に記載のコーティング装置。
(17) 前記真空源及び電源は、前記デバイス区画とは別個のベースに組み込まれている、実施態様16に記載のコーティング装置。
(18) 前記ベースの前記真空源は、可撓性ホースを介して前記デバイス区画に流体接続され、前記電源は、真空リード及び/又は電力リードをバッグ内の前記ヒータに運ぶように構成されたワイヤリードを介して前記熱源に電気的に接続されている、実施態様17に記載のコーティング装置。
(19) 物体に治療薬をコーティングするための方法であって、
コーティングされる物体を開放可能かつ封止可能なデバイス区画内に置くステップと、
前記デバイス区画を封止するステップと、
前記デバイス区画に真空源から真空を適用するステップと、
治療薬で前記デバイス区画を満たし、コーティングされる前記物体にコーティングするために、前記治療薬を気化させるステップと、
コーティングされた前記物体を前記デバイス区画から除去するステップと、
を含む、方法。
(20) 前記真空源は、前記デバイス区画と流体連通している、実施態様19に記載の方法。
(22) 前記デバイス区画は剛性壁を有する、実施態様19に記載の方法。
(23) 前記デバイス区画はベースに接続され、前記ベースは真空源を組み込んでいる、実施態様19に記載の方法。
(24) 前記デバイス区画は、前記ベースに取り外し可能かつ封止可能に連結されており、前記ベースと前記デバイス区画との間に電気的接続部及び真空接続部が延びている、実施態様23に記載の方法。
(25) 前記治療薬は担体に取り込まれる、実施態様19に記載の方法。
(27) 前記吸収性ポリマーは、ラクチドグリコリドコポリマーである、実施態様26に記載の方法。
(28) 前記担体は、前記熱源に隣接して位置付けられる、実施態様25に記載の方法。
(29) 前記デバイス区画は可撓性側面を有し、前記熱源は、前記可撓性側面内に位置付けられ、かつ、前記可撓性側面から熱的に絶縁された抵抗加熱トレースを備える、実施態様19に記載の方法。
(30) 前記デバイス区画は、第1の端部上で開放可能かつ封止可能であり、前記真空源は、前記デバイス区画の封止された第2の端部に流体接続される、実施態様29に記載の方法。
(32) 前記ベース内の前記真空源は、可撓性ホースを介して前記デバイス区画に流体接続され、前記電源は、ワイヤリード介して前記熱源に電気的に接続されている、実施態様31に記載の方法。
(33) 前記物体が気化した前記治療薬よりも約50℃~約150℃低温になるように、前記物体と前記気化した治療薬との間に温度勾配を確立することによって、前記物体上への前記気化した治療薬の堆積を促進するステップと、前記物体を前記気化した治療薬と接触させるステップと、を更に含む、実施態様19に記載の方法。
(34) 前記接触させるステップは、約1分~約15分の範囲の期間にわたって継続される、実施態様33に記載の方法。
(35) 接触させる前記期間中に、前記物体の温度が15℃未満だけ上昇する、実施態様34に記載の方法。
前記医療用デバイス上への気化した治療薬の堆積を、前記医療用デバイスと前記気化した治療薬との間に温度勾配を確立することによって促進するステップと、前記物体を前記気化した治療薬と接触させるステップと、を含む、方法。
(37) 前記医療用デバイスは、前記気化した治療薬よりも約50℃~約150℃低温である、実施態様36に記載の方法。
(38) デバイス区画を開放し、前記医療用デバイスを前記デバイス区画内に置き、前記デバイス区画を閉じるステップと、
閉じた前記デバイス区画を排気するステップと、
前記気化した治療薬を前記閉じたデバイス区画と連通させるステップと、
前記デバイス区画を開放し、前記医療用デバイスを除去するステップと、
を更に含む、実施態様36に記載の方法。
(39) 前記気化した治療薬が加熱された状態にある間、前記医療用デバイスを前記気化した治療薬と接触させるステップ、
を更に含む、実施態様38に記載の方法。
(40) 前記接触させるステップ中に、前記医療用デバイスの温度が15℃未満だけ上昇する、実施態様39に記載の方法。
Claims (40)
- 治療薬のコーティングを適用するためのコーティング装置であって、
開放可能かつ封止可能なデバイス区画と、
前記デバイス区画と連通するように位置付けられた治療薬と、
前記治療薬を気化させるための熱源と、
前記デバイス区画と流体連通している真空源と、
を備える、コーティング装置。 - 前記デバイス区画は剛性壁を有する、請求項1に記載のコーティング装置。
- 前記デバイス区画はベースに接続され、前記ベースは前記真空源を組み込んでいる、請求項2に記載のコーティング装置。
- 前記デバイス区画は、前記ベースに取り外し可能かつ封止可能に連結されており、前記ベースと前記デバイス区画との間に電気的接続部及び真空接続部が延びている、請求項3に記載のコーティング装置。
- 前記治療薬は担体に取り込まれる、請求項1に記載のコーティング装置。
- 前記治療薬はトリクロサンであり、前記担体は、シリコーン製のシート若しくはパッド若しくはフィルム、又は吸収性ポリマーから作製されたシート若しくはパッド若しくはフィルムである、請求項5に記載のコーティング装置。
- 前記吸収性ポリマーは、ラクチドグリコリドコポリマーである、請求項6に記載のコーティング装置。
- 前記担体は、前記熱源に隣接して位置付けられる、請求項5に記載のコーティング装置。
- 前記治療薬はトリクロサンである、請求項1に記載のコーティング装置。
- 前記デバイス区画は、可撓性側面を有する、請求項1に記載のコーティング装置。
- 前記熱源は、前記デバイス区画内に配置された蛇行した電気抵抗箔の形態の電気抵抗ヒータである、請求項10に記載のコーティング装置。
- 前記デバイス区画の前記側面と前記熱源との間に熱絶縁を提供するために、前記熱源の上方の前記デバイス区画内に位置付けられた第1のスペーサメッシュと、前記デバイス区画の前記側面と前記熱源との間に位置付けられた第2のスペーサメッシュと、を更に備える、請求項11に記載のコーティング装置。
- 前記治療薬は、前記第1のスペーサメッシュ上にコーティングされる、請求項12に記載のコーティング装置。
- 前記治療薬は、前記熱源上にコーティングされる、請求項12に記載のコーティング装置。
- 前記治療薬は、前記熱源に隣接して配置された担体上に又は前記担体内に装填される、請求項12に記載のコーティング装置。
- 前記デバイス区画は、第1の端部上で開放可能かつ封止可能であり、前記真空源は、前記デバイス区画の封止された第2の端部に流体接続される、請求項10に記載のコーティング装置。
- 前記真空源及び電源は、前記デバイス区画とは別個のベースに組み込まれている、請求項16に記載のコーティング装置。
- 前記ベースの前記真空源は、可撓性ホースを介して前記デバイス区画に流体接続され、前記電源は、真空リード及び/又は電力リードをバッグ内の前記ヒータに運ぶように構成されたワイヤリードを介して前記熱源に電気的に接続されている、請求項17に記載のコーティング装置。
- 物体に治療薬をコーティングするための方法であって、
コーティングされる物体を開放可能かつ封止可能なデバイス区画内に置くステップと、
前記デバイス区画を封止するステップと、
前記デバイス区画に真空源から真空を適用するステップと、
治療薬で前記デバイス区画を満たし、コーティングされる前記物体にコーティングするために、前記治療薬を気化させるステップと、
コーティングされた前記物体を前記デバイス区画から除去するステップと、
を含む、方法。 - 前記真空源は、前記デバイス区画と流体連通している、請求項19に記載の方法。
- 前記気化させるステップは、熱源を用いて行われる、請求項19に記載の方法。
- 前記デバイス区画は剛性壁を有する、請求項19に記載の方法。
- 前記デバイス区画はベースに接続され、前記ベースは真空源を組み込んでいる、請求項19に記載の方法。
- 前記デバイス区画は、前記ベースに取り外し可能かつ封止可能に連結されており、前記ベースと前記デバイス区画との間に電気的接続部及び真空接続部が延びている、請求項23に記載の方法。
- 前記治療薬は担体に取り込まれる、請求項19に記載の方法。
- 前記治療薬はトリクロサンであり、前記担体は、シリコーン製のシート若しくはパッド若しくはフィルム、又は吸収性ポリマーから作製されたシート若しくはパッド若しくはフィルムである、請求項25に記載の方法。
- 前記吸収性ポリマーは、ラクチドグリコリドコポリマーである、請求項26に記載の方法。
- 前記担体は、前記熱源に隣接して位置付けられる、請求項25に記載の方法。
- 前記デバイス区画は可撓性側面を有し、前記熱源は、前記可撓性側面内に位置付けられ、かつ、前記可撓性側面から熱的に絶縁された抵抗加熱トレースを備える、請求項19に記載の方法。
- 前記デバイス区画は、第1の端部上で開放可能かつ封止可能であり、前記真空源は、前記デバイス区画の封止された第2の端部に流体接続される、請求項29に記載の方法。
- 前記真空源及び電源は、前記デバイス区画とは別個のベースに組み込まれている、請求項19に記載の方法。
- 前記ベース内の前記真空源は、可撓性ホースを介して前記デバイス区画に流体接続され、前記電源は、ワイヤリード介して前記熱源に電気的に接続されている、請求項31に記載の方法。
- 前記物体が気化した前記治療薬よりも約50℃~約150℃低温になるように、前記物体と前記気化した治療薬との間に温度勾配を確立することによって、前記物体上への前記気化した治療薬の堆積を促進するステップと、前記物体を前記気化した治療薬と接触させるステップと、を更に含む、請求項19に記載の方法。
- 前記接触させるステップは、約1分~約15分の範囲の期間にわたって継続される、請求項33に記載の方法。
- 接触させる前記期間中に、前記物体の温度が15℃未満だけ上昇する、請求項34に記載の方法。
- 埋め込み可能な医療用デバイス上に治療薬を堆積させる方法であって、
前記医療用デバイス上への気化した治療薬の堆積を、前記医療用デバイスと前記気化した治療薬との間に温度勾配を確立することによって促進するステップと、前記物体を前記気化した治療薬と接触させるステップと、を含む、方法。 - 前記医療用デバイスは、前記気化した治療薬よりも約50℃~約150℃低温である、請求項36に記載の方法。
- デバイス区画を開放し、前記医療用デバイスを前記デバイス区画内に置き、前記デバイス区画を閉じるステップと、
閉じた前記デバイス区画を排気するステップと、
前記気化した治療薬を前記閉じたデバイス区画と連通させるステップと、
前記デバイス区画を開放し、前記医療用デバイスを除去するステップと、
を更に含む、請求項36に記載の方法。 - 前記気化した治療薬が加熱された状態にある間、前記医療用デバイスを前記気化した治療薬と接触させるステップ、
を更に含む、請求項38に記載の方法。 - 前記接触させるステップ中に、前記医療用デバイスの温度が15℃未満だけ上昇する、請求項39に記載の方法。
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