JP5498962B2 - 損傷組織の処置のための装置および方法 - Google Patents
損傷組織の処置のための装置および方法 Download PDFInfo
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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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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
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- F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
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- F16L37/28—Couplings of the quick-acting type with fluid cut-off means
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- A61M1/98—Containers specifically adapted for negative pressure wound therapy
- A61M1/984—Containers specifically adapted for negative pressure wound therapy portable on the body
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
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- Biomedical Technology (AREA)
- Hematology (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
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Description
本出願は、2008年2月14日に出願された「Devices and Methods for Treatment of Damaged Tissue」というタイトルの米国仮特許出願第61/028,835号の優先権の利益を主張し、その全体が本明細書に参考として援用される。
創傷を処置するための大気圧より低い圧力の使用は、古代文明まで遡ることができる。例えば、古代中国は、身体から悪い体液を取り出すために、ガラスチャンバを炎燃させることによって、減圧環境を生成する技術である、「吸角法」を使用していた。最新の研究では、減圧を損傷組織に印加するによって、以下のいくつかの有益な効果をもたらし得ることが明らかにされている。1)減圧レベルは、損傷組織縁の後退につながり、したがって、欠陥サイズを縮小させ、創傷収縮を促進することによって、治癒を早め得る。2)減圧は、機械的刺激を損傷組織に提供して、創傷床における増殖因子を解放し、治癒を促進し得る。3)減圧は、損傷組織腔内に吸引力を生成して、損傷組織腔から壊死組織を除去し、細菌数を減少させ得る。4)減圧の印加は、損傷組織への血流を増加させて、治癒を早め得る。5)減圧は、メタロプロテイナーゼ酵素を阻害する肉芽組織を除去して、組織再形成および治癒を向上させ得る。
非電気的に動力供給される減圧治療装置を採用することによる、創傷の処置を含む、損傷組織の処置のための方法および装置が、開示される。ユーザへの使用不快感を最小限にする一方、発生される大気圧より低い圧力の保守および制御が、そのような装置によって提供されてもよい。いくつかの実施形態では、減圧治療装置は、吸引器具と、シーラント層と、接触基質と、任意の延長管類とを備える。吸引器具は、非電気的に動力供給される装置であってもよく、静音および/または装着式であるように構成されてもよい。いくつかの実施形態では、吸引器具は、衣類の下に目立たないように装着され得るように、薄型を有してもよい。シーラント層は、損傷組織上に実質的に気密性の封入体を生成し、吸引器具と、損傷組織を含有する封入体との間に流体連通を提供してもよい。流体連通は、吸引器具とシーラント層との間の直接接続によって提供されてもよく、または吸引器具と取付けポートとを接続する延長管類を通して提供されてもよい。いくつかの実施形態では、シーラント層は、可撓性であってもよいが、他の実施形態では、シーラント層は、半剛性または剛性であってもよい。いくつかの実施例では、半剛性または剛性シーラント層は、処置部位へのシーラント層の処理または適用を促進する一方、シーラント層自体に折り重なりおよび接着し得る危険性を低減あるいは排除してもよい。延長管類は、コネクタあるいは継手を使用して、シーラント層および/または吸引器具に連結されてもよい。コネクタは、任意に、解放可能係止機構を備え、延長管類の取付けならびに取外しを促進し、および/または偶発的切断を防止してもよい。例えば、解放可能係止機構は、管類の取付けおよび/または取外しの際に操作され得る、係止機構としての役割を果たす、解放ボタンまたは他のアクチュエータを備えてもよい。他の実施形態では、吸引器具は、シーラント層取付けポートに直接接続されてもよく、延長管類と同一または類似コネクタを伴うコネクタを備え、吸引器具の直接取付けおよび管類を使用した遠隔取付けの両方を可能にしてもよい。
(項目1)
患者の処置のためのシステムであって、
a.シーラント層と、該シーラント層を貫通する内腔を伴って構成される可撓性取付けポートとを備える、シール可能な創傷カバー部と、
b.i.長手方向軸と、該長手方向軸に直角の非円形断面形状と、150cc以下の容積とを伴う、取外し可能吸引チャンバと、
ii.該長手方向軸に沿って、該吸引チャンバ内を摺動するように構成され、該長手方向軸に直角の非円形断面形状と、非平面近位外周とを有する、ピストンアセンブリと、
iii.該ピストンアセンブリに連結され、該吸引チャンバ内の圧力を少なくとも50mmHg減圧するように構成される、少なくとも2つの実質的に一定力のバネコイルと、
iv.該ピストンアセンブリを押動するように構成され、係止機構を備える、装填ツールと、
v.該シール可能な創傷カバー部に解放可能に取付けられ、該取外し可能吸引チャンバに解放可能に取付けられるように構成される、コネクタ管と
を備える、減圧発生アセンブリと
を備える、システム。
(項目2)
患者の処置のためのシステムであって、
a.シーラント層と、該シーラント層を貫通する内腔を伴って構成される可撓性取付けポートとを備える、シール可能な創傷カバー部と、
b.該取付けポートに連結するように構成され、非円形断面形状を伴う吸引チャンバを備える、非電気的に動力供給される減圧発生アセンブリと
を備える、システム。
(項目3)
前記減圧発生アセンブリは、少なくとも1つの実質的に一定力の部材を備える、項目2に記載のシステム。
(項目4)
前記減圧発生アセンブリは、少なくとも2つの実質的に一定力の部材を備える、項目2に記載のシステム。
(項目5)
前記減圧発生アセンブリは、少なくとも1つの一定力の部材をポテンシャルエネルギーによって機械的に装荷するように構成される、伸長剛性部材を備える、項目3に記載のシステム。
(項目6)
少なくとも1つの力部材は、弾性である、項目3に記載のシステム。
(項目7)
少なくとも1つの弾性の力部材は、一定力のバネである、項目6に記載のシステム。
(項目8)
前記減圧発生アセンブリは、移動軸に沿って、前記吸引チャンバ内を摺動するように構成されるシールアセンブリをさらに備える、項目3に記載のシステム。
(項目9)
前記減圧発生アセンブリは、少なくとも1つのリボンバネを備える、項目2に記載のシステム。
(項目10)
少なくとも1つのリボンバネは、実質的に一定力のリボンバネである、項目9に記載のシステム。
(項目11)
前記減圧発生アセンブリは、少なくとも1つの可変力部材を備える、項目8に記載のシステム。
(項目12)
少なくとも1つの可変力部材は、前記シールアセンブリに作用する少なくともいくらかの摩擦を相殺するように構成される、項目11に記載のシステム。
(項目13)
前記減圧発生アセンブリは、吸引チャンバ内容物に関係なく、前記移動軸に沿って、固定外寸を維持するように構成される、項目8に記載のシステム。
(項目14)
前記減圧発生アセンブリは、吸引チャンバ内容物に関係なく、固定外側構成を有する、項目8に記載のシステム。
(項目15)
前記非平面近位外周は、湾曲非平面近位外周である、項目8に記載のシステム。
(項目16)
前記減圧発生アセンブリは、第1の寸法と、該第1の寸法と垂直の第2の寸法と、該第1および第2の寸法と垂直の第3の寸法とを備え、該第1の寸法は、該減圧発生アセンブリの最大寸法であって、該第3の寸法は、約5cm以下である、項目2に記載のシステム。
(項目17)
前記第2の寸法は、前記第3の寸法よりも大きい、項目16に記載のシステム。
(項目18)
前記第3の寸法は、約4cm以下である、項目16に記載のシステム。
(項目19)
前記第3の寸法は、約3cm以下である、項目16に記載のシステム。
(項目20)
前記第3の寸法は、約2cm以下である、項目16に記載のシステム。
(項目21)
前記第3の寸法は、約1cm以下である、項目16に記載のシステム。
(項目22)
前記吸引チャンバは、約500cc以下の容積を有する、項目16に記載のシステム。
(項目23)
前記吸引チャンバは、約250cc以下の容積を有する、項目16に記載のシステム。
(項目24)
前記吸引チャンバは、約100cc以下の容積を有する、項目16に記載のシステム。
(項目25)
前記減圧発生アセンブリは、少なくとも−75mmHg減圧するように構成される、項目4に記載のシステム。
(項目26)
前記減圧発生アセンブリは、少なくとも−100mmHg減圧するように構成される、項目4に記載のシステム。
(項目27)
前記減圧発生アセンブリは、少なくとも−125mmHg減圧するように構成される、項目4に記載のシステム。
(項目28)
前記伸長剛性部材は、解放可能係止機構を備える、項目5に記載のシステム。
(項目29)
前記解放可能係止機構は、ラッチと、該ラッチに連結される解放ボタンとを備える、項目28に記載のシステム。
(項目30)
前記シールアセンブリは、少なくとも1つの一定力の部材に押圧するように構成される少なくとも1つの湾曲表面を備える、項目8に記載のシステム。
(項目31)
前記シールアセンブリは、前記少なくとも1つの湾曲表面と異なる少なくとも1つの凸面構造を備える、項目30に記載のシステム。
(項目32)
前記吸引力発生アセンブリは、前記吸引チャンバとの流体連通を制御するように構成される弁をさらに備える、項目2に記載のシステム。
(項目33)
前記弁は、回転可能ノブに連結される、項目32に記載のシステム。
(項目34)
前記シール可能な創傷カバー部と、前記吸引力発生アセンブリとに連結されるように構成されるコネクタ管をさらに備える、項目2に記載のシステム。
(項目35)
組織治療装置であって、
a.シール可能な創傷カバー部と、
b.一定範囲の回収容積にわたって、その外寸を実質的に維持するように構成され、非円形断面形状を有する、装着式吸引力発生装置と
を備える、装置。
(項目36)
前記減圧発生装置は、非電気的に動力供給される、項目35に記載の装置。
(項目37)
前記減圧発生装置は、弾性の力部材を備える、項目36に記載の装置。
(項目38)
前記力部材は、一定力のバネである、項目37に記載の装置。
(項目39)
前記減圧発生装置は、ポテンシャルエネルギーによって機械的に装荷されるように適合される、項目38に記載の装置。
(項目40)
前記減圧発生装置は、実質的に非円筒形形状を有する、項目35に記載の装置。
(項目41)
前記減圧発生装置は、少なくとも2つの吸引チャンバを備える、項目36に記載の装置。
(項目42)
前記減圧発生装置は、少なくとも2つの独立吸引チャンバを備える、項目41に記載の装置。
(項目43)
前記減圧発生装置は、前記吸引チャンバから分離した1つの回収チャンバをさらに備える、項目41に記載の装置。
(項目44)
患者の処置のための装置であって、
a.カバーと、該カバーと垂直の旋回軸の周囲を旋回するように構成される一体型可撓性取付けポートとを備える、シール可能な創傷カバー部と、
b.吸引チャンバが、減圧を発生させ、滲出液を回収し、容積範囲にわたって、実質的に一定レベルの減圧を自己維持するように構成される、非円形減圧発生器具と
を備える、装置。
(項目45)
前記容積範囲は、少なくとも50ccである、項目44に記載の装置。
(項目46)
前記容積範囲は、少なくとも100ccである、項目44に記載の装置。
(項目47)
前記減圧発生器具は、弾性の力部材を備える、項目44に記載の装置。
(項目48)
前記減圧発生器具は、前記弾性の力部材を機械的に再装荷するように構成される、項目47に記載の装置。
(項目49)
前記減圧発生ユニットは、非電気的に動力供給される、項目44に記載の装置。
(項目50)
前記取付けポートは、前記シール可能な創傷カバー部と、前記減圧発生器具との間の流体連通を可能にするように構成される、項目44に記載の装置。
(項目51)
前記減圧発生器具は、一定範囲の吸引チャンバ容積にわたって、一定外側構成を維持するように構成される、項目44に記載の装置。
(項目52)
患者の処置のためのシステムであって、
a.シール可能な創傷カバー部であって、該創傷カバー部を通して流体連通を提供し、創傷の周囲をシールして創傷封入体を形成するように構成される一体型可撓性取付けポートを備える、創傷カバー部と、
b.弾性の力部材と、該弾性の力部材をポテンシャルエネルギーによって装荷するように構成される剛性部材とを備える、非円形減圧発生装置と
を備える、システム。
(項目53)
前記取付けポートは、前記シール可能な創傷カバー部と実質的に平行に旋回するように構成される、項目52に記載のシステム。
(項目54)
前記弾性の力部材は、一定力のバネである、項目52に記載のシステム。
(項目55)
前記減圧発生装置は、非電気的に動力供給される、項目52に記載のシステム。
(項目56)
前記減圧発生装置は、重力に対する該減圧発生装置の配向に関係なく、実質的に一定圧力レベルを維持するように構成される、項目54に記載のシステム。
(項目57)
前記減圧発生装置は、該減圧発生装置内の吸引容積に関係なく、固定外寸を維持するように構成される、項目54に記載のシステム。
(項目58)
患者を処置するための方法であって、
a.非電気的に動力供給される非円形減圧発生装置を創傷カバー部から取外すステップと、
b.減圧を発生させずに、該減圧発生装置をポテンシャルエネルギーによって装荷するステップと、
c.該再装荷された減圧発生装置を該創傷カバーに取付けるステップと、
d.該再装荷された減圧発生装置を起動して、該創傷カバー部下の封入体内に減圧を発生させるステップと
を含む、方法
(項目59)
患者を処置するための方法であって、
a.創傷カバーを身体部位に対してシールすることと、
b.伸長長さと、該伸長長さと直角の非円形断面形状とを有する減圧発生装置を使用して、該身体部位における圧力レベルを低減することであって、該減圧発生装置は、その外寸を変更することなく、かつ、該身体部位に対するその配向に関係なく、該創傷部位において、実質的に一定の減圧レベルを実質的に維持するように適合するように構成される、ことと
を含む、方法。
(項目60)
非円形吸引チャンバ内の移動軸に沿って、非円形シールを摺動させることをさらに含み、該シールおよび該吸引チャンバは、該移動軸と直角の非円形構成を有する、項目59に記載の方法。
実施形態が本明細書に記載および提示されているが、それらの実施形態は、一例として提供されるに過ぎない。本発明から逸脱することなく、変形、変更、および代用が、成されてもよい。本明細書に記載される例示的実施形態の種々の代替が、本発明を実践する際に採用されてもよいことに留意されたい。本明細書に記載される実施形態すべてに対して、方法のステップが、連続的に行なわれる必要はない。
Claims (28)
- 入口開口部と剛性側壁とを含むチャンバであって、該チャンバは、減圧を生成することと、かつ、該減圧生成の間に創傷からの滲出液を回収することとの両方に適合された、チャンバと、
該チャンバ内に配置されたシール機構であって、該シール機構は、該チャンバの剛性側壁と共に真空抵抗シールを形成し減圧生成の間に該チャンバの長軸に沿って摺動するように構成されている外周部を含む、シール機構と、
該チャンバ内に配置され該シール機構に取り付けられたバネ機構と
を含む、減圧治療システムであって、
該バネ機構は、2つのリボンバネを含み、該2つのリボンバネの各々は、内側表面と、外側表面と、該内側表面と該外側表面との間の縁とを含み、各リボンバネの該内側表面は、他のリボンバネの該内側表面に面している、減圧治療システム。 - 前記リボンバネの各々は、実質的に一定力のバネを含む、請求項1に記載のシステム。
- 前記チャンバは、遠位端壁と近位開口部とをさらに含む、請求項1から2のうちのいずれか一項に記載のシステム。
- 前記チャンバの入口開口部は、前記遠位端壁上に配置されている、請求項3に記載のシステム。
- 前記チャンバの剛性側壁は、非円形断面形状を含む、請求項3または4に記載のシステム。
- 前記非円形断面形状は、楕円形である、請求項5に記載のシステム。
- 前記チャンバの近位開口部に取り付けられた端部キャップをさらに含む、請求項3から6のうちのいずれか一項に記載のシステム。
- 前記端部キャップにバネ機構が取り付けられている、請求項7に記載のシステム。
- 前記端部キャップは、2つのバネ機構取り付け場所をさらに含む、請求項8に記載のシステム。
- 前記端部キャップは、前記2つのバネ機構取り付け場所の間に配置された作動開口部をさらに含む、請求項9に記載のシステム。
- 前記シール機構は、表面を受ける少なくとも1つの湾曲したバネをさらに含む、請求項1から10のうちのいずれか一項に記載のシステム。
- 前記シール機構は、前記表面を受ける少なくとも1つの湾曲したバネに隣接する開口部を受ける少なくとも1つのバネをさらに含む、請求項11に記載のシステム。
- 作動ツールをさらに含む、請求項8に記載のシステム。
- 前記シール機構は、作動ツールを取り外し可能に受けるようにさらに構成されている、請求項13に記載のシステム。
- 前記シール機構を、前記チャンバ内の装填された位置で取り外し可能に固定するように構成された固定機構をさらに含む、請求項14に記載のシステム。
- 前記固定機構は、前記作動ツール上に配置され、前記端部キャップに取り外し可能に取り付けるように構成される、請求項15に記載のシステム。
- 前記固定機構は、ラッチ機構を含む、請求項16に記載のシステム。
- 前記チャンバの剛性側壁上の潤滑油をさらに含む、請求項1から17のうちのいずれか一項に記載のシステム。
- シーラント層と、該シーラント層を貫通する内腔を伴って構成される可撓性取付けポートとを含む、シール可能な創傷カバー部をさらに含む、請求項1から18のうちのいずれか一項に記載のシステム。
- 前記シール可能な創傷カバー部は、
第1の側面と、第2の側面と、該第1の側面と該第2の側面との間の開口部とを含む可撓性カバー部と、
該カバー部の第1の側面に配置された接着剤と、
該カバー部の第2の側面に取り付けられたポートであって、該ポートは、該カバー部の開口部と連通する内腔を含む、ポート部と
を含む、請求項19に記載のシステム。 - 前記接着剤は、前記カバー部の第1の側面上に配置された親水コロイド接着剤である、請求項20に記載のシステム。
- 前記ポートは、可撓性ポートである、請求項20または21に記載のシステム。
- 前記シール可能な創傷カバー部に取付け、かつ、該取外し可能な吸引チャンバに取付けるように構成されたコネクタ管をさらに含む、請求項20から22のうちのいずれか一項に記載のシステム。
- 前記チャンバは、300cc以下の容積を有する、請求項1から23のうちのいずれか一項に記載のシステム。
- 前記チャンバは、少なくとも50ccの容積を有する、請求項24に記載のシステム。
- 前記減圧治療システムは、第1の寸法と、該第1の寸法と垂直の第2の寸法と、該第1の寸法および該第2の寸法と垂直の第3の寸法とを備え、該第1の寸法は、該減圧治療システムの最大寸法であって、該第3の寸法は、約5cm以下である、請求項1から25のうちのいずれか一項に記載のシステム。
- 前記減圧治療システムは、少なくとも−50mmHg減圧するように構成されている、請求項1から26のうちのいずれか一項に記載のシステム。
- 前記チャンバは、前記シール機構によって分離された回収チャンバと作業チャンバとを含む、請求項1から27のうちのいずれか一項に記載のシステム。
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