JP2019527566A - センサが使用可能な創傷監視および治療装置 - Google Patents
センサが使用可能な創傷監視および治療装置 Download PDFInfo
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- JP2019527566A JP2019527566A JP2018556978A JP2018556978A JP2019527566A JP 2019527566 A JP2019527566 A JP 2019527566A JP 2018556978 A JP2018556978 A JP 2018556978A JP 2018556978 A JP2018556978 A JP 2018556978A JP 2019527566 A JP2019527566 A JP 2019527566A
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Abstract
Description
大きすぎて自然には閉じられない、もしくはそうでなければ、創傷の部位への陰圧の印加では治癒しない、開放創または慢性創傷の治療は、当該技術分野ではよく知られている。現在当該技術分野で知られている陰圧創傷療法(NPWT)システムは、創傷の上に流体に対して不透過性または半透過性のカバーを設置することと、創傷を囲む患者の組織に対してカバーを封止する、様々な手段を使用することと、陰圧をカバーの真下に作り出し維持するような手法で、陰圧の源(真空ポンプなど)をカバーに接続することとを伴う。そのような陰圧は、有害なサイトカインまたは細菌を包含する場合がある、過度の流体を除去しながら同時に、創傷部位で肉芽組織の形成を容易にし、平常の体内炎症プロセスを支援することによって、創傷の治癒を促進すると考えられる。しかしながら、治療の便益を完全に実現するには、NPWTのさらなる改良が必要とされる。
図1A〜Bは、流体コネクタ110と連動して創傷被覆材100を用いる、陰圧創傷治療システム10の実施形態を示す。図中、流体コネクタ110は、近位端130および遠位端140を有するブリッジ120などの細長い導管と、ブリッジ120の遠位端140にアプリケータ180とを備えてもよい。任意の連結器160は、ブリッジ120の近位端130に配置され得る。キャップ170が、システムに提供されてもよい(一部の場合、図示する通り、連結器160に取り付けられ得る)。キャップ170は、近位端130から流体が漏出するのを妨げるときに有用であり得る。システム10は、ポンプまたは陰圧を供給できる陰圧ユニット150など、陰圧の源を含んでもよい。ポンプは、創傷滲出液、および創傷から除去されてもよい他の流体を貯蔵する、キャニスタまたは他の容器を備えてもよい。キャニスタまたは容器はまた、ポンプとは別に提供されてもよい。一部の実施形態では、図1A〜1Bに示すように、ポンプ150は、Smith&Nephewより販売される、PICO(商標)ポンプなど、キャニスタなしのポンプであり得る。ポンプ150は、管190を介して連結器160に接続してもよく、またはポンプ150は、連結器160に直接、もしくはブリッジ120に直接接続してもよい。使用中、被覆材100は、一部の場合、発泡体またはガーゼなどの創傷パッキング材料で埋められてもよい、好適に準備された創傷の上に設置される。流体コネクタ110のアプリケータ180は、被覆材100の隙間の上に設置され、被覆材100の最上表面に封止される、密封表面を有する。流体コネクタ110の被覆材100への接続の前、間、または後のいずれかに、ポンプ150は、管190を介して連結器160へ接続されるか、または連結器160もしくはブリッジ120へ直接接続される。その後ポンプが起動され、それによって陰圧を創傷に供給する。陰圧の印加は、所望するレベルの創傷治癒を達成するまで行われてもよい。
図2Aに示す通り、一部の実施形態では、流体コネクタ110は、以下にさらに詳細に記載するであろう通り、被覆材100と流体連通する拡大遠位端または頭部140を備え得る。一実施形態では、拡大遠位端は丸い形または円形を有する。頭部140は、図中、被覆材100の縁近くに位置するように示しているが、被覆材上のいずれの場所に位置してもよい。例えば、一部の実施形態は、被覆材100の縁または角上または近くではない、中心または中心から外れた場所に提供されてもよい。一部の実施形態では、被覆材10は、二つ以上の流体コネクタ110を備えてもよく、各々、それと流体連通する一つ以上の頭部140を備える。一部の実施形態では、頭部140は、最も幅の広い縁に沿って30mmあってもよい。頭部140は、上に記載した、創傷被覆材の最上表面に対して封止されるように構成される、アプリケータ180を少なくとも一部形成する。
いくつかのセンサを組み込む創傷被覆材、または創傷被覆材から切り離されたセンサは、治癒するとき創傷の特性を監視するために、または一つ以上の危険因子もしくは創傷を引き起こす場合がある状態を特定するために、利用され得る。うまく治癒する創傷とそうでない創傷とからデータを収集することによって、創傷が治癒軌道上にあるか、被覆材を調整する必要があるか、療法パラメータを調整する必要があるか、または類似のことを含む、一つ以上の状態を示す、測定値または測定量を特定するのに有用な洞察を提供し得る。これによって、一つ以上の調整を行うことが可能になり得る。例えば、陰圧創傷療法デバイスの動作パラメータ(例えば、圧力レベル、治療強度、治療期間など)は調整し得る。一つ以上のセンサが、本明細書に記載する通りの、様々な生理学的パラメータを測定するように使用され得る。
図4A〜Dは、一部の実施形態に従い、患者の創傷部位を治療するように使用される、陰圧療法創傷治療システムの使用を示す。図4Aは、治療のために清潔にされ準備されている、創傷部位400を示す。図中、創傷部位400を囲む健康な皮膚は清潔にされ、過度の毛は除去または剪毛され得る。創傷部位400はまた、必要な場合、無菌食塩水で洗浄されてもよい。任意で、皮膚保護剤が創傷部位400を囲む皮膚に塗布されてもよい。必要な場合、発泡体またはガーゼなどの創傷パッキング材料が、創傷部位400の中に設置されてもよい。これは、創傷部位400がより深い創傷の場合に好ましい場合がある。
本明細書に提供する閾値、制限、期間などのいかなる値も、絶対的であることを意図せず、したがって近似であり得る。加えて、本明細書に提供するいかなる閾値、制限、期間なども、自動的にまたはユーザによってのいずれかで、固定または変化し得る。さらに、本明細書に使用する通り、参照値に関する、例えば、超える、より大きい、より少ないなどの相対的用語は、参照値と等しいことを網羅することもまた意図している。例えば、正の値である参照値を超えることは、参照値と等しいか、または参照値より大きいことを網羅し得る。加えて、本明細書に使用する通り、参照値に関する、例えば、超える、より大きい、より少ないなどの相対的用語はまた、参照値に関する、下回る、より少ない、より大きいなどの開示する関係の逆を網羅することもまた意図している。さらに、様々な過程のブロックについて、値がある特定の閾値を満たすか否かを判定する点に関して記載してもよいものの、ブロックは、例えば、(i)閾値を下回るまたは上回る値、または(ii)閾値を満足するもしくは満足しない値に関して同様に理解され得る。
Claims (41)
- 創傷監視装置であって、
創傷と接触して位置するように構成される、創傷被覆材を備え、前記創傷被覆材は、一つ以上のセンサを支持する、少なくとも一つの実質的に可撓性のある基材を備える、装置。 - 前記少なくとも一つの実質的に可撓性のある基材は、実質的に可撓性のあるプリント回路を備える、請求項1に記載の装置。
- 前記実質的に可撓性のあるプリント回路は、可撓性ポリマーを含む、請求項2に記載の装置。
- 前記少なくとも一つの実質的に可撓性のある基材は、実質的に可撓性のある非導電メッシュを備える、請求項1〜3のいずれかに記載の装置。
- 前記一つ以上のセンサは、互いに電気的に接続される複数のセンサを備え、前記複数のセンサはさらに、コントローラおよび電源と電気的に接続されるように構成される、請求項1〜4のいずれかに記載の装置。
- 前記一つ以上のセンサは、一つ以上の温度センサ、伝導度センサ、マルチスペクトル光学測定センサ、pHセンサ、圧力センサ、比色センサ、光学センサ、紫外線(UV)センサまたは赤外線(IR)センサを備える、請求項1〜5のいずれかに記載の装置。
- 前記一つ以上のセンサと電気的に連通するコントローラをさらに備え、前記コントローラは、前記一つ以上のセンサからデータを受信し、前記創傷と関連する一つ以上の状態を判定するよう、前記一つ以上のセンサにより収集される前記データを処理するために、ホストソフトウェアを使用するように構成される処理デバイスへ、前記データを伝達するように構成される、請求項1〜6のいずれかに記載の装置。
- 前記コントローラまたは前記処理デバイスのうちの少なくとも一つは、前記創傷と関連する前記一つ以上の状態に基づき、前記創傷が治癒しつつあると示すように構成される、請求項7に記載の装置。
- 前記コントローラは、前記一つ以上のセンサまたは前記処理デバイスのうちの少なくとも一つと無線通信するように構成される、請求項7に記載の装置。
- 前記コントローラは、前記一つ以上のセンサまたは前記処理デバイスのうちの少なくとも一つと、電気配線によって電気的に連通するように構成される、請求項7に記載の装置。
- 前記処理デバイスは、パーソナルコンピュータ(PC)、タブレット形式のコンピュータデバイス、スマートフォンまたはカスタムコンピュータデバイスを備える、請求項7〜10のいずれかに記載の装置。
- 前記一つ以上のセンサにより収集される前記データは、クラウドへ伝達されるように構成される、請求項7〜11のいずれかに記載の装置。
- 前記創傷被覆材は、創傷接触層を備え、前記基材は、前記創傷接触層上または中に位置する、請求項1〜12のいずれかに記載の装置。
- 前記創傷接触層は、第1創傷接触層および第2創傷接触層を備え、前記基材は、前記第1および第2創傷接触層の間に挟まれる、請求項13に記載の装置。
- 前記一つ以上のセンサのうちの少なくとも一つは、前記創傷と直接接触するように構成され、前記一つ以上のセンサのうちの前記少なくとも一つは、前記第1創傷接触層と前記第2創傷接触層との間で被包される、請求項14に記載の装置。
- 前記一つ以上のセンサは、前記創傷と直接接触するように構成される、少なくとも一つの第1センサと、前記創傷に接触しないように構成される、少なくとも一つの第2センサとを備える、請求項13〜15のいずれかに記載の装置。
- 前記創傷接触層の上に位置する吸収層と、前記創傷接触層の上に位置する裏当て層とをさらに備え、前記創傷接触層は、前記裏当て層に封止される、請求項13〜15のいずれかに記載の装置。
- 前記裏当て層上にポートをさらに備え、前記ポートは、前記創傷被覆材を陰圧の源に接続するように構成される、請求項16に記載の装置。
- 前記創傷被覆材は、前記陰圧を使用することなく、前記創傷を治療するように構成される、多層創傷被覆材の中に含まれる、請求項1〜17のいずれかに記載の装置。
- 前記創傷被覆材とは別に、前記創傷の上に位置するように構成される、創傷パッキング層およびドレープをさらに備える、請求項1〜19のいずれかに記載の装置。
- 前記創傷被覆材と流体連通するように構成され、さらに陰圧を前記創傷に印加するように構成される、陰圧源をさらに備える、請求項1〜18または20のいずれかに記載の装置。
- 創傷監視装置であって、
創傷または前記創傷を囲む皮膚のうちの一つ以上と接触して位置するように構成される、創傷被覆材を備え、前記創傷被覆材は、複数のセンサを支持する、少なくとも一つの実質的に可撓性のある基材を備え、前記複数のセンサのうちの第1センサは、前記基材上に位置し、前記創傷を囲む前記皮膚の測定を得るように構成される、装置。 - 前記複数のセンサのうちの第2センサは、前記基材上に位置し、前記創傷の測定を得るように構成される、請求項22に記載の装置。
- 前記基材は、前記創傷の面積を少なくとも一部超えて延在するサイズであり、前記創傷を囲む皮膚の上に少なくとも一部位置するように構成される、請求項22〜23のいずれかに記載の装置。
- 前記創傷被覆材は、創傷接触層を備える、請求項22〜24のいずれかに記載の装置。
- 前記少なくとも一つの実質的に可撓性のある基材は、実質的に可撓性のあるプリント回路、または実質的に可撓性のある非導電メッシュのうちの少なくとも一つを備える、請求項22〜25のいずれかに記載の装置。
- 前記実質的に可撓性のあるプリント回路は、可撓性ポリマーを含む、請求項26に記載の装置。
- 前記複数のセンサのうちの少なくとも一部は、互いに電気的に接続され、前記複数のセンサは、コントローラおよび電源と電気的に接続されるように構成される、請求項22〜27のいずれかに記載の装置。
- 前記コントローラは、前記複数のセンサからデータを受信し、前記創傷と関連する一つ以上の状態を判定するために、前記受信したデータを処理するように構成されるコンピュータデバイスに、前記受信したデータを伝達するように構成される、請求項28に記載の装置。
- 前記コントローラまたは前記処理デバイスのうちの前記少なくとも一つは、前記創傷と関連する前記一つ以上の状態に基づき、前記創傷が治癒しつつあると示すように構成される、請求項29に記載の装置。
- 前記複数のセンサは、一つ以上の温度センサ、伝導度センサ、マルチスペクトル光学測定センサ、pHセンサ、圧力センサ、比色センサ、光学センサ、紫外線(UV)センサまたは赤外線(IR)センサを備える、請求項22〜30のいずれかに記載の装置。
- 前記複数のセンサは、前記創傷を囲む前記皮膚の領域の超音波スイープを実施するように構成される、皮膚弾力性センサを備える、請求項22〜31のいずれかに記載の装置。
- 創傷監視装置を操作する方法であって、
創傷と接触して位置するように構成される創傷被覆材で、創傷または前記創傷を囲む皮膚のうちの少なくとも一つを監視することを含み、前記創傷被覆材は、一つ以上のセンサを支持する、少なくとも一つの実質的に可撓性のある基材を備える、方法。 - 前記基材上に位置する第1センサで、前記創傷を囲む前記皮膚を監視することと、前記基材上に位置する第2センサで、前記創傷を監視することと、をさらに含む、請求項33に記載の方法。
- 前記一つ以上のセンサは、一つ以上の温度センサ、伝導度センサ、マルチスペクトル光学測定センサ、pHセンサ、圧力センサ、比色センサ、光学センサ、紫外線(UV)センサまたは赤外線(IR)センサを備える、請求項33〜34のいずれかに記載の方法。
- 前記基材は、前記創傷の面積を少なくとも一部超えて延在するサイズであり、前記創傷を囲む皮膚の上に少なくとも一部位置するように構成される、請求項33〜35のいずれかに記載の方法。
- 前記少なくとも一つの実質的に可撓性のある基材は、実質的に可撓性のあるプリント回路、または実質的に可撓性のある非導電メッシュのうちの少なくとも一つを備える、請求項33〜36のいずれかに記載の方法。
- 前記実質的に可撓性のあるプリント回路は、可撓性ポリマーを含む、請求項37に記載の方法。
- 前記一つ以上のセンサのうちの少なくとも一部は、互いに電気的に接続され、前記一つ以上のセンサは、コントローラおよび電源と電気的に接続されるように構成される、請求項33〜38のいずれかに記載の方法。
- 前記コントローラによって、前記一つ以上のセンサからデータを受信することと、前記創傷と関連する一つ以上の状態を判定するために、前記受信したデータを処理するように構成されるコンピュータデバイスに、前記受信したデータを伝達することと、をさらに含む、請求項39に記載の方法。
- 前記創傷と関連する前記一つ以上の状態に基づき、前記創傷が治癒しつつあると示すことを、さらに含む、請求項40に記載の方法。
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US20190290496A1 (en) | 2019-09-26 |
US20240009035A1 (en) | 2024-01-11 |
US11717447B2 (en) | 2023-08-08 |
EP3454918A1 (en) | 2019-03-20 |
SG11201809829UA (en) | 2018-12-28 |
CA3023772A1 (en) | 2017-11-16 |
AU2017264907A1 (en) | 2018-12-20 |
ZA201808297B (en) | 2019-08-28 |
WO2017195038A1 (en) | 2017-11-16 |
AU2022202996A1 (en) | 2022-05-26 |
CN109069712A (zh) | 2018-12-21 |
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