JP4964869B2 - 創傷治療機器および方法 - Google Patents
創傷治療機器および方法 Download PDFInfo
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- JP4964869B2 JP4964869B2 JP2008508299A JP2008508299A JP4964869B2 JP 4964869 B2 JP4964869 B2 JP 4964869B2 JP 2008508299 A JP2008508299 A JP 2008508299A JP 2008508299 A JP2008508299 A JP 2008508299A JP 4964869 B2 JP4964869 B2 JP 4964869B2
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- wound
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- irrigation
- pump
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N silicon dioxide Inorganic materials O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 1
- 229910001961 silver nitrate Inorganic materials 0.000 description 1
- 238000004088 simulation Methods 0.000 description 1
- 210000001626 skin fibroblast Anatomy 0.000 description 1
- ZOOPHYLANWVUDY-UHFFFAOYSA-M sodium;undecanoate Chemical compound [Na+].CCCCCCCCCCC([O-])=O ZOOPHYLANWVUDY-UHFFFAOYSA-M 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000003351 stiffener Substances 0.000 description 1
- 229960005322 streptomycin Drugs 0.000 description 1
- 230000035882 stress Effects 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
- 125000003831 tetrazolyl group Chemical group 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000009210 therapy by ultrasound Methods 0.000 description 1
- 229960004072 thrombin Drugs 0.000 description 1
- 239000003106 tissue adhesive Substances 0.000 description 1
- 229940075469 tissue adhesives Drugs 0.000 description 1
- 229960003500 triclosan Drugs 0.000 description 1
- 238000000108 ultra-filtration Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
- 229940072358 xylocaine Drugs 0.000 description 1
Images
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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- A61M2205/00—General characteristics of the apparatus
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- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Vascular Medicine (AREA)
- Pulmonology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Surgery (AREA)
- Physics & Mathematics (AREA)
- Fluid Mechanics (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- External Artificial Organs (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
以下のような往復動ポンプが使用されることができる。
ピストンポンプ − 特に、創傷床上で正圧および/または負圧に対して、ピストンが逆止め弁を通して流体を汲み上げる場合。
薄膜ポンプ − 1つまたは2つの可撓性隔膜の脈動が、逆止め弁で液体を変位させる場合。
また、以下のような回転ポンプも使用されることができる。
発展キャビティ
ポンプ − 特に、より高い粘度および粒子状物質充填浸出液に対して、協働ねじ回転子および固定子を備えている。
真空ポンプ − 圧力調整装置を備えている。
以下のような往復動ポンプが使用されることができる。
シャトルポンプ − 2から50ml/分までの速度で流体を移動させる発振シャトル機構を備えている。
また以下のような回転ポンプも使用されることができrう
遠心ポンプ
可撓性羽根車
ポンプ − エラストマー羽根車が、羽根車ブレードとポンプハウジングを通して流体を一掃する成形ハウジングの間で流体を捕捉する。
蠕動ポンプ − 管内の流体電流を回転子の方向に押すように、可撓性流体吸引管に作用する回転子アーム上に周面ローラを備えている。
回転翼ポンプ − 回転するときに脈動することなく流体を移動させる駆動シャフトに取り付けられた回転翼付ディスクを備えている。出口は、ポンプを損傷することなく絞ることができる。
[細胞]
35mlのDMEM/10%FCS媒体を入れたT175フラスコで、37℃/5%CO2で成長させたヒト皮膚線維芽細胞(HS8/BS04)が、PBS内で洗浄され、1×トリプシン/EDTA(37℃で5分間)を使用して持ち上げられた。トリプシン抑制は、遠心分離(Hereus Megafuge 1.0R;1000rpmで5分間)によってペレットした10mlのDMEM/10%FCS媒体および細胞を加えることによって達成された。媒体は捨てられ細胞は、10mlのDMEM/10%FCSに再び懸濁された。細胞は、血球計を使用して計数し、100,000細胞/mlが得られるまでDMEM/10%FCSで希釈した。
細胞は、5%胎児牛血清、I−グルタミン、非必須アミノ酸、およびペニシリン/ストレプトマイシン(様々な多数)で補完したDMEM媒体(Sigma、no.D6429)内で成長させた。実験システムで使用された媒体は、媒体の安定pHを保証するために、Buffer−All媒体(Sigma、lot 51K2311)で緩衝させた。
オートクレーブシステムを組み立てる前に、媒体(50ml)を各ボトルに運んだ。カバースリップを挿入する前に、ミヌセルチャンバを4mlの媒体で充填した。システムは図1で示すように設定した(ポンプ1、asset5715;0.2ml/分で運転するように設定されたポンプ2、asset4586;加熱板は45(Cに設定した; Discofix 3方向バルブ(Arnolds、lot 04A2092042 c/z)、真空ポンプ、llmvac VCZ 310(950mbarに設定)。
チャンバがいっぱいになった場合に、媒体を0.2ml/分で連続してシステムを通して汲み上げた。ミヌセルチャンバは、ポンプから配管を切断し、3方向バルブを切り換えて、取り付けた0.22μmフィルタを空気を通すことを可能にすることによって空にされた。十分空にした場合、3方向バルブをバルブとポンプの間でシステムを閉じるように切り換え、それによってシステム内に真空を形成することが可能になる。3方向バルブの上昇により、媒体が重力流によって0.22μmフィルタを通過しないことが保証された。1時間後、3方向バルブは開始位置に切り換えて戻されて、ミヌセルチャンバを充填することが可能になり、管をポンプに再接続することが可能になる。SEQシステムは表1のように処理した。
連続潅注/吸引システムは、媒体が細胞を潅注し、950mbarに設定された真空で吸引された状態で、24時間運転させた。大気圧は、1048mbarの最大値まで毎日変わり、したがってシステムと大気の圧力差は常に10%より低かった。
媒体は最初の1時間ミヌセルシステムを通して循環しており、ミヌセルチャンバは変換器を使用して超音波装置の上に配置した。ミヌセルチャンバは20分間の超音波処理を受け、その後加熱板上に配置された。各ミヌセルチャンバへ運ぶための最適強度および波長は、100MW/CM2の電力(強度)で1.5MHzであることが測定された。超音波特性は普通、関連する創傷および包帯の特性を考慮するように、あらゆる特定の付加または創傷包帯に対して最適化しなければならないだろう。本発明で使用される値は、実験機器での比較的高い減衰を補償するように、比較的高い強度であった。
細胞ミトコンドリア活性を測定するWST分析は、カバーストリップ上で行った。WST試薬(Roche、lot 11264000)は、全ての媒体でDMEM/10%FSC/緩衝液の10%v/vまで希釈した。カバースリップ(n=6)は、各Mnucellチャンバから取り除き、1mlのPBSで洗浄した。PBSを取り除き、200μlのWST/DMEM媒体を加えた。カバースリップはその後、150μlを96ウェルプレートに運ぶ前に、45分間37℃で培養させた。Ascent Multiskan Microtitireプレートリーダを使用して、655nmを基準にして450nmの吸収度が測定された。
超音波処理を行ったかどうかに関わらず、SIAおよびSEQシステム内で成長した細胞のミトコンドリア活性を、WST分析を使用して測定した。
2 創傷包帯
3 裏当て層
4 シールまたはクロージャ
6 入口管
7 流体供給管
8 点
9 出口管
10 流体移送管
11 点
12 流体リザーバ
12B 流体リザーバ
13 流体吸引管
14 バルブ
16 バルブ
17 創傷
18 薄膜ポンプ
18A 第1の装置
18B 第2の装置
21 機器
41 包帯
42 フィルム裏当て層
43 創傷に面した面
Claims (32)
- 創傷を吸引し、潅注し、および/または洗浄する機器であって、
a)比較的流体密なシールまたはクロージャを創傷上に形成することが可能な裏当て層を有する適合創傷包帯を含む流体流路、および創傷の潅注および/または吸引を可能にするように創傷に面した面を通しておよび/またはその下を通過する少なくとも1つの管であって、使用の際前記少なくとも1つの管が比較的流体密なシールまたはクロージャを創傷上に形成する前記創傷に面した面を通しておよび/またはその下を通過する点がある流体流路と、
b)前記少なくとも1つの管に流体供給管によって連結可能な流体リザーバと、
c)流体を前記創傷包帯を通して前記創傷まで移動させる、および/または流体を前記創傷から移動させる少なくとも1つの装置と、を備えた機器であって、
d)5〜100mW/cm2の間の空間ピーク一時平均音響強度で高周波振動エネルギーを前記潅注流体および/または創傷浸出液を介して前記創傷床に加える手段を備えていることを特徴とする機器。 - 潅注を可能にするように流体供給管に連結する少なくとも1つの入口管と、吸引を可能にするように流体移送管に連結する少なくとも1つの出口管と、を有し、そのそれぞれが創傷に面した面を通しておよび/または創傷に面した面の下を通過することを特徴とする請
求項1に記載の機器。 - 吸引流体を前記流体移送管を通して装置によって吸引しながら、前記流体供給管を介して前記流体リザーバから流路を充填するように潅注流体を供給することができるように、創傷の同時吸引および潅注を行う手段を備えたことを特徴とする請求項2に記載の機器。
- 前記高周波振動エネルギーは超音波エネルギーであることを特徴とする請求項1から3のいずれか一項に記載の機器。
- 前記高周波振動エネルギーを加える手段は、高周波振動ソノードを備えていることを特徴とする請求項1から4のいずれか一項に記載の機器。
- 前記高周波振動エネルギー場の発生源は前記ソノードと一体であることを特徴とする請求項5に記載の機器。
- 前記高周波振動エネルギーを加える手段は、ソノード変換器を備えていることを特徴とする請求項5または6のいずれかに記載の機器。
- 前記高周波振動エネルギー場の発生源は、高周波振動接続手段によって前記ソノードに連結されていることを特徴とする請求項5に記載の機器。
- 前記創傷床に前記高周波振動エネルギーを加える手段は、前記包帯の上、中または内側で本体の遠位方向に取り付けられていることを特徴とする請求項1から8のいずれか一項に記載の機器。
- 前記高周波振動エネルギーを加える手段は、包帯裏当て層の中心に、またはその近くに設けられていることを特徴とする請求項1から9のいずれか一項に記載の機器。
- 前記高周波振動エネルギーを加える手段は、相対積層部材の形をしていることを特徴とする請求項1から10のいずれか一項に記載の機器。
- 前記創傷床に前記高周波振動エネルギーを加える手段は、前記裏当て層の前記創傷に面した面を通しておよび/またはその下を通過する前記少なくとも1つの管中に、その上に、そこに、またはその近くに取り付けられていることを特徴とする請求項1から11のいずれか一項に記載の機器。
- 前記創傷床に前記高周波振動エネルギーを加える手段は、前記機器の前記流路を形成する前記管内の前記コネクタの1つまたは複数の中に、その上に、そこに、またはその近くに取り付けられていることを特徴とする請求項1から12のいずれか一項に記載の機器。
- 前記創傷床に前記高周波振動エネルギーを加える手段は、前記リザーバの中に、その上に、そこに、またはその近くに取り付けられていることを特徴とする請求項1から13のいずれか一項に記載の機器。
- 前記高周波振動エネルギーを加える手段は、軸と、前記軸に対して所定の角度で前記超音波の伝播を集束させる集束要素とを含む変換器を備えていることを特徴とする請求項1から14のいずれか一項に記載の機器。
- 前記高周波振動エネルギーを加える手段は、20kHzから10MHzの間の周波数で超音波エネルギーを与えることが可能であることを特徴とする請求項1から15のいずれか一項に記載の機器。
- 前記高周波振動エネルギーを加える手段は、脈動させた方法で前記超音波を加えることが可能であることを特徴とする請求項1から16のいずれか一項に記載の機器。
- 前記エネルギーは、比較的低周波変調信号を有する振動波形全体上で規則的またはランダムで脈動されることを特徴とする請求項17に記載の機器。
- 前記エネルギーは、5Hzから10kHzの周波数で脈動されることを特徴とする請求項16または17に記載の機器。
- 前記創傷の同時吸引および潅注手段は、前記創傷包帯の下流側でそこから離れるように流体に加えられる前記創傷を通して流体を移動させる第1の装置と、
前記創傷包帯の上流側で、これに向かって前記流体供給管内の前記潅注剤に加えられる前記創傷を通して流体を移動させる第2の装置と、
前記流体移送管に連結された吸引流調整手段と、
前記流体供給管に連結された供給流調整手段のうちの少なくとも1つと組み合わせて備えていることを特徴とする請求項3に記載の機器。 - 前記創傷を通して流体を移動させる前記第1および/または第2の装置は、可変スループット装置であることを特徴とする請求項20に記載の機器。
- 前記第1および/または第2の装置は、可変速度ポンプであることを特徴とする請求項21に記載の機器。
- 前記創傷を通して流体を移動させる前記第1および/または第2の装置は、往復動ポンプまたは回転ポンプであることを特徴とする請求項22に記載の機器。
- 前記第1の装置は薄膜ポンプであることを特徴とする請求項23に記載の機器。
- 前記第2の装置は蠕動ポンプであることを特徴とする請求項23に記載の機器。
- 前記可変スループット装置は、脈動、連続、可変および/または自動および/またはプログラム可能流体移動が可能であることを特徴とする請求項21から25のいずれか一項に記載の機器。
- 前記創傷内に最大50%atmの負圧を加えることが可能であることを特徴とする請求
項1から26のいずれか一項に記載の機器。 - 前記流体のあらゆる明らかな圧縮または減圧を生じさせることを可能にするように、十分な弾性を圧力に対して有し、且つ前記創傷床への、前記創傷床上での、また前記創傷床からの流路内の少なくとも1つの物体を備えていることを特徴とする請求項26に記載の機器。
- 前記1つまたは複数の管は、延長領域上で前記創傷床へ流体を直接運び、および/または前記創傷床から直接流体を受容するための開口で前記創傷床のかなりの面積を覆い、これと接触するマニホールドを備えていることを特徴とする請求項1から28のいずれか一項に記載の機器。
- 固定手段が前記創傷の部位に前記創傷包帯を固定するように設けられたことを特徴とする請求項1から29のいずれか一項に記載の機器。
- 比較的流体密なシールまたはクロージャを創傷上に形成することが可能である、創傷に面した面を備えた裏当て層と、
前記創傷の潅注および/または吸引を可能にするように前記創傷に面した面を通しておよび/またはその下を通過する少なくとも1つの管と、
使用の際前記入口管および出口管が比較的流体密なシールまたはクロージャを創傷上に形成する前記創傷に面した面を通しておよび/またはその下を通過する点と、
を備えた適合可能な創傷包帯であって、
5〜100mW/cm2の間の空間ピーク一時平均音響強度で高周波振動エネルギーを前記潅注流体および/または創傷浸出液を介して前記創傷床に加える手段を備えていることを特徴とする創傷包帯。 - 抗菌ポーチ内に設けられたことを特徴とする請求項31に記載の創傷包帯。
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2006
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- 2006-04-27 EP EP16200711.6A patent/EP3167916A1/en not_active Withdrawn
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US9044579B2 (en) | 2015-06-02 |
GB0508531D0 (en) | 2005-06-01 |
CN101208114A (zh) | 2008-06-25 |
CA2606245C (en) | 2015-12-08 |
US20150335917A1 (en) | 2015-11-26 |
CN104127920A (zh) | 2014-11-05 |
US10035006B2 (en) | 2018-07-31 |
AU2006238957B2 (en) | 2012-08-30 |
US11147714B2 (en) | 2021-10-19 |
WO2006114638A3 (en) | 2007-03-08 |
ZA200709198B (en) | 2009-03-25 |
JP2008538960A (ja) | 2008-11-13 |
WO2006114638A2 (en) | 2006-11-02 |
CN104127920B (zh) | 2018-05-08 |
EP3167916A1 (en) | 2017-05-17 |
AU2006238957A1 (en) | 2006-11-02 |
US20090306580A1 (en) | 2009-12-10 |
KR20070122545A (ko) | 2007-12-31 |
US20190015648A1 (en) | 2019-01-17 |
ES2623548T3 (es) | 2017-07-11 |
EP1874375B1 (en) | 2017-02-15 |
CA2606245A1 (en) | 2006-11-02 |
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