JP4174066B2 - 皮膚の表面再生装置 - Google Patents
皮膚の表面再生装置 Download PDFInfo
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Description
本発明は、一般的には、コラーゲン含有組織を収縮する方法及び装置に関し、詳細には、外表面に1度以下の熱傷を生成しながら、コラーゲン含有組織を収縮するための方法及び装置に関する。
皮膚は、基本的には、2つの要素、表皮とその下層の真皮とから構成される。下層側の真皮は、皮膚の主構造支持体となっている。表皮は、上皮細胞とメラノサイトと呼ばれる色素形成細胞とを含む。表皮は人体の全体に渡って厚さが変化する。例えば、皮膚は、背中においてまぶたの25倍の厚さがある。
真皮は、主に、コラーゲンと呼ばれる細胞外タンパク質で構成されている。コラーゲンは、熱不安定性の化学結合部及び熱安定性の化学結合部に連結されている、3つのポリペチド鎖を持つトリプルヘリックスとして存在する。コラーゲンが加熱されると、このタンパク質の物理的性質における変化が、特性温度において生ずる。この構造的遷移は、特定の収縮温度において生ずる。
皮膚の切除の処理は、固有の傷跡に起因して、その応用において制限がある。 フェイスリフト法を用れば、耳の輪郭の回りの傷跡を隠すことができ、外科的な傷跡の改善と美容整形上の改善との間の許容し得る妥協を得ることができる。しかし、腰部や大腿部や腕や肘や脚部の外科的切除は、きれいな目立たない傷跡をもつ適当な改善を提供するだけでしかない。加えて、患者は、痛くてしかも不自由になるかもしれない術後の治療を受けなければならない。更に、出血や化膿等の他のリスクの要因が、治療を引き延ばすかもしれない。
メラノサイトや他の上皮細胞を損傷することなく、あるいは外科的な介在なしに、皮膚をタイトにするための要求がある。更に、メラノサイトや他の上皮細胞を損傷することなく、脂肪細胞を非外科的に除去するための要求がある。
より身体を傷つける、外科的な熱傷や色素側の影響のない、コラーゲンを皮下において収縮する要求がある。更に、選択した組織部分の熱傷コラーゲンの形成及び収縮を、その選択した組織部分の表面には2度以上の深い熱傷を作らないようにして、皮下において誘導させる要求がある。
本発明の一つの目的は、メラニン細胞およびその他の上皮細胞を実質的に損傷せずに皮膚を緊張させるための方法および装置を提供することである。
本発明のもう一つ別の目的は、メラニン細胞およびその他の上皮細胞に実質的に影響を与えることなく脂肪の小胞を減少させるために充分な熱エネルギーを与える方法および装置を提供することである。
本発明のさらに別の目的は、繊維性隔膜組織におけるコラーゲンを変性させることによって輪郭変形させるための方法および装置を提供することである。
本発明のさらに別の目的は、外科的傷跡や色素沈着の副次的作用なしにコラーゲンを熱的に再整形および収縮させるための方法を提供することである。
本発明のさらに別の目的は、傷跡コラーゲンの形成および収縮を生ぜしめるための方法を提供することである。
本発明のさらに別の目的は、骨膜組織における骨質皮膚硬結の形成および収縮を生ぜしめるための方法を提供することである。
本発明のさらに別の目的は、収縮したコラーゲン組織の上の組織表面に形成される第二度熱傷より深くなく、好ましくは、第一度熱傷より深くなくコラーゲン組織を収縮させるための方法を提供することである。
種々な電磁エネルギー源を使用することができる。適当なエネルギー源としては、これらに限定するわけではないが、RF、マイクロ波、超音波等がある。一つの実施例によれば、好ましいエネルギー源は、RFである。
図2は、皮膚とその下部組織の横断面図である。
図3は、コラーゲン網の概略図である。
図4は、表皮のメラニンその他の上皮細胞を実質的に変形せずにコラーゲン組織を部分的に変成することにより、下部の皮下層又はそれよりも深い柔組織層に電磁エネルギーを照射する装置の概略図である。
図5は、本発明で利用できるRFシステムのブロック図である。
図6は、本発明の一実施例の処理回路のブロック図である。
明確化のため、以下の定義を与える。
先在コラーゲンとは、皮膚、腱、軟骨その他の結合組織の白繊維(コラーゲン繊維)に通常存在するタンパク質である。
傷跡コラーゲン沈着の熱誘導とは、熱傷により誘導された炎症に対する反応としてのコラーゲン沈着の除去不可能な新合成プロセスである。得られた傷跡コラーゲンはしばしば先在に対抗して初期と呼ばれる。
標準熱勾配とは、皮膚表面上における大きな熱含有量である。
皮膚を通じて(transcutaneously)とは、放射装置が電磁エネルギーを組織表面に直接照射することを意味する。
粘膜を通じて(transmucosal)とは、放射装置が電磁エネルギーを粘膜に直接照射することを意味する。
皮膚を通して(permucosal)とは、放射装置が内視鏡、間接鏡等を介して粘膜に挿入されることを意味する。
二度の熱傷とは、表皮と真皮の変異性部分を破壊する熱傷を意味する。
三度の熱傷とは、表皮と真皮を含む皮膚の全厚を破壊する熱傷を意味する。
本発明は、(i)選択された組織の部位の組織表面の下に傷跡のコラーゲンを形成して収縮させる方法、(ii)選択された骨膜組織部位に皮膚硬結沈着を形成する方法、(iii)表皮のメラニンその他の上皮細胞を実質的に変形せずに下部のコラーゲン組織に熱エネルギー源から放射エネルギーを照射する装置、(iv)コラーゲン組織で作られた繊維性隔膜(septae)を持つ脂肪の小房を含む下部の皮下層又はそれより深い柔組織層電磁エネルギーを照射する装置を提供する。
本発明の方法は、細胞の完全な壊死を与えるものではなく、望ましい外形結果を与え、コラーゲン繊維で作られた繊維性隔膜を持つ脂肪の小房が、下部のコラーゲン組織層に加えられた逆熱勾配を使用してコラーゲンの部分的な変成を生じてそれが堅くなるのを可能にする。これは小房内で脂肪細胞の全てを殺すことなく達成される。
本発明の方法に対する正しい応用は、軟らかい組織の強く、固くすること、副靭帯の弛緩による不安定な接合箇所の治療、不安定な脊椎カラムの障害の治療、腹壁の弱さの治療、接続性組織の治療、逆流を伴う食堂のヘルニア、女性の尿失禁、マイクロカーディウム(mycrocardium)のディスダイナミックセグメントや血管の異常拡張、睡眠の無呼吸、皮膚の弛緩や皺寄り等を含むが、これらに限定されない。
コラーゲンの熱改造は、生の(皮膚の)コラーゲンおよび治療の過程の一部として生成されるコラーゲンと共に生じる。傷の治療は、痕跡として形態学的に現れる速い発生コラーゲンの生成期間に続く初期の炎症を起こす段階を含む。コラーゲンの生物物理学の特性はその起源に無関係に同じである。
多孔性の膜18が電解液20を受けるようになっている。この多孔性の膜18は膨らんで、膜18の接触外面22が表皮層12に馴染んで密接に熱接触するようになる。多孔性の膜18の冷却内房24に入る冷却流体が表皮層12を冷却する。
電磁源28は電磁電極26に接続されており、そして電解液30の源は多孔性の膜18に接続されている。
本発明の一つの方法では外皮の下の真皮内のコラーゲン組織は加熱装置を使用して経皮的に収縮させられる。下になっている真皮へ外皮を通して経皮的に電磁エネルギーを与える。下になっている真皮内で繊維芽細胞の増殖が始まる。真皮内でスカー・コラーゲンが形成される。次にこのスカー・コラーゲンが収縮させられ、そして皮膚が引っ張られる。
一般に、RF電極26は単極もしくは双極である。単極モードでは、患者の外皮へ当てた導電パッドの形をした戻り電極から身体の組織を通して無線周波数電流を流す。電流密度が最大になったところで最大の加熱が生じる。
多孔性の膜18は絶縁材料からつくれる。ここでの目的では絶縁は熱エネルギーもしくは電気エネルギーの流れに対する障壁である。表皮層12へ電解液20を調整して送れる材料から多孔性の膜18をつくる。多孔性の膜18をつくる様々な材料は、これらに限定するものではないが、編んだポリエステル、連続繊維状ポリエステル、ポリエステル・セルローズ、レイヨン、ポリアミド、ポリウレタン、ポリエチレン等である。適当な市販製品としては、(i)センチナル・プロダクツ・コーポレーション、ヒャニーズ、マスから市販されているオプセルと、(ii)ウイルシャー・コンタミネーション・コントロール、カールスバッド、カリフォルニアから市販のアルトラソーブHC4201もしくはHT4644MDがある。RF電極26の周りにポケットもしくは領域56を形成してもよい。
瘢痕及び色素分泌不規則性が避けられるので、外科切除、レーザ及び化学的表面直しの標準的方法では、以前は「禁止領域」であると考えられていた領域において、皮膚又はその他の張りが生じる。コラーゲンの逆熱勾配収縮を有する皮膚の張りは、標準技術での見苦しい瘢痕無しに、大腿部、膝、腕、背中及びヒップを含み、これらに限定されない領域を修正することが出来る。更に、顔面及び首の弛み及び皺取りの様なエステティク法で以前に修正されていた領域は、外科手術、即ち、典型的な耳の回りでの切開を必要無しに、修正することが出来る。妊娠からの腹部の皮膚の弾力線維症、即ち伸びは、成長腹部の広い範囲に渡っての切開無しに修正することが出来る。本発明は乳房固定又は乳房の持ち上げに対しても使用することが出来る。
集束要素60は、凸レンズとすることが出来ることは明らかである。更に、集束60は、多孔膜18内で、表皮層12と多孔膜18との間の外部16に位置することが出来る。更に、集束要素60を多孔膜18と結合する結合装置62が含まれている。或る実施の形態においては、結合装置62は、多孔膜18の周囲の回りに位置され、且つ多孔膜18に関して集束要素50を支持するブラケットである。
他の実施の形態においては、繊維状隔膜としてコラーゲン組織を有する脂肪房形成から成る下方の領域がある人体の領域を脂肪彫刻するための方法は、表皮層12から脂肪層の所望の下方房形成への逆熱勾配を作りだすことを含む。充分な電磁エネルギーは、表皮層12を介して供給されるが、メラノサイト及び他の上皮細胞を損傷したり、大きく変化することは無く、他の皮膚層を通して、繊維状隔膜のコラーゲン組織上に集束される。電磁エネルギーは、脂肪細胞の最小の破壊を有して、コラーゲン組織を部分的変性する。これは、部分的に変性することによって、例えば、コラーゲン分子の熱不安定クロスリンクを裂くことにより達成される。逆熱勾配は、細胞内脂肪の正味の流動を作りだすが、脂肪細胞の破壊は減少する。
制限なく、パワー源28は、RF源であり得る。RFパワー源28は、エネルギーをRFパワー発生器64に与え、そしてRF電極26に与える。マルチプレクサ66は、各RF電極26に関連する多数の熱センサで、電流、電圧及び温度を測定する。RF電極26は、個々に測定される。マルチプレクサ66は、デジタル又はアナログのコントローラ、又はソフトウエアで動作するコンピュータであるコントローラ68によって駆動される。コントローラ68がコンピュータであるとき、システムバスを介して接続されるCPUを含む。このシステムには、従来技術で知られているように、キーボード、ディスク駆動装置、不揮発性メモリ装置、表示装置、及び他の周辺装置が含まれている。更に、そのバスに接続されているのはプログラムメモリ及びデータメモリである。
電流及び電圧はインピーダンスを計算するために使用される。診断の段階が最初に実行されて、治療の活動のレベルを決定する。このことは、超音波及び他の手段によって行われる。診断は、治療の前後においても行われる。
計算された温度及びインピーダンスの値は、表示装置74で表示される。又は、温度又はインピーダンスの数字表示に加えて、計算された温度又はインピーダンスの値は、温度及びインピーダンス制限を有するマイクロプロセッサ84によって比較される。その値が所定の温度又はインピーダンスを超えるとき、警告が表示装置74に示されて、更に、RFエネルギーの各電極への送出が減少するか、又は別の電極に対して多重化される。マイクロプロセッサ84からの制御信号が、RF発生器64によるパワーレベルを減少させるか、又はいづれかの特定の電極に送出されたパワーのエネルギーを減少させる。コントローラ68は、送られた温度及びインピーダンスを示すデジタル値を受信し、そしてそれを記憶する。計算された表面温度及び温度は、コントローラ68によって、表示装置74に転送される。望む場合、表皮層12の計算された表面温度は制限温度と比較されて、警告信号が表示装置74に転送される。同様に、温度又はインピーダンスの値が所定のレベルを超えるとき、制御信号がRFパワー源26に送られる。
Claims (31)
- 熱エネルギーを提供するためのエネルギー源(28);
外部皮膚層表面(12)を通じて、下部のコラーゲン組織(14)に前記エネルギー源からの熱エネルギーを伝達してコラーゲン組織を熱エネルギーにより加熱するように構成されたエネルギー供給装置;
外部皮膚層表面(12)を冷却する冷却素子(24);
エネルギー供給装置に結合してエネルギー供給装置をコントロールするコントローラ(68);
を備える皮膚を引き締めるための装置(10)であって、
エネルギー供給装置が電極(26)及び集束素子(60)を含み、
前記電極(26)及び集束素子(60)により十分な熱エネルギーをコラーゲン組織(14)に供給させて、コラーゲン組織(14)を収縮しかつ外部皮膚層表面(12)を引き締めるのに十分に高い温度までコラーゲン組織(14)を加熱するようにコントローラ(68)が構成されており、
コラーゲン組織が加熱される間、外部皮膚層表面(12)を十分に冷却して、外部皮膚層表面(12)においてより低くかつ下部コラーゲン組織(14)においてより高い温度である逆熱勾配を生成させ、それにより十分に外部皮膚層表面(12)を冷却して、コラーゲン組織(14)が収縮する間、外部皮膚層表面(12)に第1度のやけどよりも強度なものを形成させないように冷却素子(24)が構成されている、ことを特徴とする、皮膚を引き締めるための装置(10)。 - 少なくとも1つのセンサー(52,76)を更に含み、コントローラ(68)が前記センサー(52,76)に結合され、その出力をコントローラ(68)が使用して熱エネルギーの供給をコントロールする、請求項1に記載の装置(10)。
- センサー(52,76)が、温度測定、インピーダンス測定または両測定のいずれかを行う、請求項2記載の装置(10)。
- コントローラ(68)が、モニターされた組織温度または電力の流れに対するインピーダンスに基づいて処理プロセス変数をコントロールするように構成された、請求項1〜3のいずれか一項に記載の装置(10)。
- 処理プロセス変数が、パワー; デューティーサイクル; 単極又は二極のエネルギー供給;電解液の供給、流量率及び圧力、並びに時間; 温度及び/又はインピーダンスを介したプロセス終了時の決定、から選択される、請求項4記載の装置(10)。
- コントローラ(68)が、治療活動のレベルを決定するために診断段階を初めに行うことができるソフトウェアとコンピューターとを含む、請求項1〜5のいずれか一項に記載の装置(10)。
- コントローラ(68)が、コラーゲン組織(14)への十分な熱エネルギー供給をコントロールして、外部皮膚層表面(12)に輪郭変形を与えるように構成されており、前記輪郭変形が、外部皮膚層表面(12)の下部の繊維性隔膜組織におけるコラーゲンを変性することにより達成される、請求項1〜6のいずれか一項に記載の装置(10)。
- コントローラ(68)が、コラーゲン組織(14)への十分な熱エネルギー供給をコントロールして、脂肪の小胞を減少させ、脂肪細胞における脂肪の正味の減少を起こし、治療皮膚領域の下の体積の正味の減少を達成するように構成された、請求項1〜7のいずれか一項に記載の装置(10)。
- コントローラ(68)が、コラーゲン組織(14)への十分な熱エネルギー供給をコントロールして、コラーゲン組織(14)におけるコラーゲンを変性するように構成された、請求項1〜8のいずれか一項に記載の装置(10)。
- コントローラ(68)が、コラーゲン組織(14)への十分な熱エネルギー供給をコントロールして、スカーコラーゲンの形成を誘導するように構成された、請求項1〜9のいずれか一項に記載の装置(10)。
- コントローラ(68)が、コラーゲン組織(14)への十分な熱エネルギー供給をコントロールして、スカーコラーゲン(14)を収縮するように構成された、請求項10に記載の装置(10)。
- 連続的な治療を行って、スカーコラーゲン(14)を収縮する、請求項11記載の装置(10)。
- エネルギー源(28)が、無線周波数、マイクロ波、レーザーまたは超音波エネルギー源である、請求項1〜12のいずれか一項に記載の装置(10)。
- エネルギー源(28)が無線周波数源である、請求項13記載の装置(10)。
- エネルギー源(28)がレーザー源である、請求項13記載の装置(10)。
- エネルギー供給装置が、インターフェース表面(22)を含む供給手段(18)と、前記供給手段(18)に結合した電極手段(26)とを含み、前記インターフェース表面(22)と外部皮膚層表面(12)を通じて下部のコラーゲン組織(14)まで熱エネルギーを伝達させるように構成された、請求項1〜15のいずれか一項に記載の装置(10)。
- エネルギー源(28)が無線周波数源であり、電極手段(26)が単極無線周波数電極である、請求項2記載の装置(10)。
- エネルギー源(28)が無線周波数源であり、電極手段(26)が二極無線周波数電極である、請求項2記載の装置(10)。
- コントローラ(68)が、外部皮膚層表面(12)及びその下の層において逆熱勾配の生成をコントロールするように構成された、請求項1〜18のいずれか一項に記載の装置(10)。
- コントローラ(68)が、コラーゲン組織を60℃より高い温度まで加熱するように構成された、請求項1〜19のいずれか一項に記載の装置(10)。
- コントローラ(68)が、コラーゲン組織を65℃より高い温度まで加熱するように構成された、請求項1〜20のいずれか一項に記載の装置(10)。
- コントローラ(68)が、コラーゲン組織を60〜80℃の温度まで加熱するように構成された、請求項1〜21のいずれか一項に記載の装置(10)。
- コントローラ(68)が、外部皮膚層表面(12)を40〜60℃の温度まで加熱するように構成された、請求項1〜22のいずれか一項に記載の装置(10)。
- 外部皮膚層表面(12)が大腿部、膝部、腕部、背中、臀部、顔面、首、腹部、または胸部上に存在する、請求項1〜23のいずれか一項に記載の装置(10)。
- コラーゲン組織(14)が、外部皮膚層表面(12)の下の真皮層に存在する、請求項1〜24のいずれか一項に記載の装置(10)。
- コラーゲン組織(14)が、皮下脂肪層に存在する、請求項1〜24のいずれか一項に記載の装置(10)。
- コントローラ(68)が、外部皮膚層表面(12)が除去されないように熱エネルギーをコントロールするように構成された、請求項1〜26のいずれか一項に記載の装置(10)。
- コントローラがフィードバックコントロールを使用している、請求項1〜27のいずれか一項に記載の装置(10)。
- 冷却素子(24)が、エネルギー供給装置内に含まれる、請求項1〜28のいずれか一項に記載の装置(10)。
- エネルギー供給装置が弾性外被を含む、請求項1〜29のいずれか一項に記載の装置(10)。
- 装置(10)がしわを治療するために使用される、請求項1〜30のいずれか一項に記載の装置(10)。
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US08/435,822 US5755753A (en) | 1995-05-05 | 1995-05-05 | Method for controlled contraction of collagen tissue |
US08/435,544 US5660836A (en) | 1995-05-05 | 1995-05-05 | Method and apparatus for controlled contraction of collagen tissue |
US08/583,815 US6241753B1 (en) | 1995-05-05 | 1996-01-05 | Method for scar collagen formation and contraction |
US08/435,822 | 1996-01-05 | ||
US08/583,815 | 1996-01-05 | ||
US08/435,544 | 1996-01-05 | ||
US60/015,112 | 1996-04-10 | ||
US08/670,857 | 1996-06-28 |
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JP2007150052A Expired - Lifetime JP4174066B2 (ja) | 1995-05-05 | 2007-06-06 | 皮膚の表面再生装置 |
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EP (2) | EP1407720A1 (ja) |
JP (2) | JP4012247B2 (ja) |
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1996
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- 1996-05-03 AU AU57893/96A patent/AU5789396A/en not_active Abandoned
- 1996-05-03 WO PCT/US1996/006274 patent/WO1996034568A1/en not_active Application Discontinuation
- 1996-05-03 JP JP53354596A patent/JP4012247B2/ja not_active Expired - Lifetime
- 1996-05-03 EP EP20040075012 patent/EP1407720A1/en not_active Ceased
- 1996-05-03 EP EP96914574A patent/EP0957791A1/en not_active Ceased
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1999
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2007
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US5660836A (en) | 1997-08-26 |
JP4012247B2 (ja) | 2007-11-21 |
AU5789396A (en) | 1996-11-21 |
WO1996034568A1 (en) | 1996-11-07 |
US5871524A (en) | 1999-02-16 |
US6405090B1 (en) | 2002-06-11 |
US6387380B1 (en) | 2002-05-14 |
JP2007268297A (ja) | 2007-10-18 |
EP0957791A1 (en) | 1999-11-24 |
JPH11504828A (ja) | 1999-05-11 |
EP1407720A1 (en) | 2004-04-14 |
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