JP2005523132A - 結合組織の超音波治療のための方法及び器具 - Google Patents
結合組織の超音波治療のための方法及び器具 Download PDFInfo
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Abstract
Description
この出願は、「結合組織の治療のための方法及び器具」というタイトルで2002年4月24日に米国特許商標庁に出願された米国シリアル第10/131,784号に対して優先権を主張する。
1.発明の分野
本発明は、治療的に結合組織を処理し、かつ/又は超音波を用いて組織内での血管新生を増加させる方法及び器具に関する。さらに詳しくは、本発明は、超音波を用いて結合組織の成長若しくは治癒を促進し、又はその病変を治療及び/若しくは予防し、又は超音波を用いて虚血性又は移植された組織での血管新生を増加させる方法及び器具に関する。
治療的に骨の損傷を処理し、評価するために超音波を用いることが知られている。適切なパラメーター、例えば、周波数、パルス繰り返し及び振幅を有する超音波パルスを骨の損傷に隣接した適切な外部位置に適切な期間当てることは、例えば骨の切断及び骨折の自然治癒を加速することが分かってきた。
本発明の方法及び器具は、上述した従来の治療に関連した問題の多くを解決する。1つの実施形態では、本発明は、疾患を有する結合組織を、結合組織の成長、治癒又は修復を促進するのに十分な周波数及び持続時間の非侵襲性で低強度の超音波にさらすことによって、必要としている哺乳類の結合組織の成長若しくは治癒を促進するか、又は病変を治療する方法に関する。
図面を参照して、本発明の特定の実施形態を後で説明する。図面は、次のように説明される。
図1は、主操作ユニット又はコントローラ及び配置モジュールを有し、本発明の方法を実施するための携帯型超音波治療器具の1つの実施形態を着用している患者の斜視図である。
図2Aは、図1に示した携帯型超音波治療器具の配置モジュールの分解図である。
図2Bは、図1に示した携帯型超音波治療器具の配置モジュールの後下面図である。
図3は、変換器アセンブリと患者の膝関節の間に配置された超音波伝導ゲルで超音波を膝関節内の結合組織に当てる本発明の1つの実施形態による変換器アセンブリを示す断面図である。
図4は、超音波変換器アセンブリの1つの実施形態のための回路構成の1つの実施形態のブロック図である。
図4Aは、超音波変換器アセンブリのための回路構成の別の実施形態のブロック図である。
図5は、携帯型超音波治療器具の第2実施形態の斜視図であり、肘関節領域内での結合組織の損傷又は病変を治療するための主操作ユニットコントローラ及び配置モジュールを示す。
図6は、携帯型超音波治療器具の第3実施形態の斜視図であり、肩関節領域内での結合組織の損傷又は病変を治療するための主操作ユニットコントローラ及び配置モジュールを示す。
図7は、携帯型超音波治療器具の第4実施形態の斜視図であり、主操作ユニットコントローラ及び配置モジュールを示す。
図8は、患者の足首に取り付けられた図7に示す携帯型超音波治療器具の斜視図である。
図9は、携帯型超音波治療器具の第5実施形態の斜視図であり、膝関節領域内での結合組織の損傷又は病変を治療するための主操作ユニット又はコントローラ及び配置モジュールを示す
図10Aは、図9に示す携帯型超音波治療器具の分解図である。
図10Bは、図9に示す携帯型超音波治療器具の支持部材の斜視図である。
図11Aは、本発明による配置モジュールの別の実施形態の側面図である。
図11Bは、図11Aの配置モジュールの後方斜視図である。
図11Cは、図11A及び11Bの配置モジュールの正面図である。
図12Aは、本発明による配置モジュールの別の実施形態の左斜視図である。
図12Bは、図12Aに示す配置モジュールの右斜視図である。
図12Cは、図12A及び12Bに示す配置モジュールの分解斜視図である。
図12Dは、図12Aから12Cに示す配置モジュールの平面図である。
図13Aは、本発明による配置モジュールの別の実施形態の左斜視図である。
図13Bは、図13Aに示す配置モジュールの右斜視図である。
図14は、肩関節領域を治療するのに適した本発明の配置モジュールの実施形態を示す。図14Aは、胴領域を覆うように適合した配置モジュールの概略図である。図14B及び14Cは、開いた(14B)及び閉じた(14C)変換器ポートの至近距離からの斜視図である。
図15Aは、調節可能な肩関節装具形の本発明の配置モジュールの別の実施形態の概略図を示す。図15B及び15Cは、開いた(15B)及び閉じた(15C)変換器ポートの至近距離からの斜視図である。
図16は、被覆部材が靴又はスニーカーである本発明の配置モジュールの実施形態を示す概略図であり、
図17Aは、配置モジュールの別の実施形態の概略図である。これは、用途が図16のものに類似しているが、被覆部材が弾性又は伸縮性である。図17Bは、変換器ポート又はアセンブリの至近距離からの概略図である。
図18Aは、手首又は手の領域へ超音波を加えるのに適した本発明による配置モジュールの実施形態の概略図である。図18Bは、変換器ポート又はアセンブリの概略分解図である。
図19は、肘関節領域に超音波を加えるのに適した本発明による配置モジュールの実施形態の概略図である。
図20Aは、本発明による治療無しでの、3週間後の羊の腱の移植片の顕微鏡写真である。
図20Bは、本発明による超音波治療有りでの、3週間後の羊の腱の移植片の顕微鏡写真である。
図21Aは、本発明による治療無しでの、6週間後の羊の腱の移植片の顕微鏡写真である。
図21Bは、本発明による超音波治療有りでの、6週間後の羊の腱の移植片の顕微鏡写真である。
図21Cは、本発明による超音波治療有りでの、6週間後の羊の腱の移植片の関節内部の顕微鏡写真である。
図21Dは、本発明による超音波治療有りでの、6週間後の羊の腱の移植片に近い骨髄の顕微鏡写真である。
図22Aは、治療無しでの、12週間後の羊の腱の移植片の関節内部の顕微鏡写真である。
図22Bは、本発明による超音波治療有りでの、12週間後の羊の腱の移植片の関節内部の顕微鏡写真である。
図22Cは、治療無しでの、12週間後の羊の腱の移植片の顕微鏡写真である。
図22Dは、本発明による超音波治療有りでの、12週間後の羊の腱の移植片の顕微鏡写真である。
図23Aは、変形性関節症を有するモルモットの超音波で治療された膝関節からの組織の顕微鏡写真である。
図23Bは、変形性関節症を有するモルモットの対照の膝関節からの組織の顕微鏡写真である。
図24は、対照と比較して、治療された組織での血管新生(新脈管形成)の存在に対する組織学的評点を示す。
図25は、対照と比較して、治療された組織での界面での骨の内殖を示す。
図26は、対照と比較して、治療された組織に対する破損までのピーク負荷を示す。
図27は、対照と比較して、移植片を破損させるのに必要なエネルギーを示す。
図28は、対照と比較して、修復された組織の硬直を示す。
図29Aは、手術をしていない(自然のままの)挿入部位を示す。
図29Bは、超音波で治療された修復を示す。
図29Cは、対照の修復組織を示す。
図30は、治療された組織に対する血管分布地の存在を示す。
図31は、治療された組織に対する組織の組織化を示す。
図32は、治療されていないものと比較して、治療された組織での巨視的な格付けを示す。
図33は、治療されていないものと比較して、治療された組織での細胞充実性を示す。
図34は、治療されていないものと比較して、治療された組織での血管分布地を示す。
図35Aは、対照の欠陥を示す。
図35Bは、超音波で治療された欠陥を示す。
本発明の超音波治療器具及び方法は、低強度で超高周波音響エネルギー(超音波)を非侵襲的に用いて、結合組織の損傷、欠陥又は病変を治療するか、又は虚血性又は移植された組織の血管新生を増加させる。結合組織の治療では、血管新生を増加させることは、結果的に治癒に貢献するが、血管新生を増加させる方法及び器具の使用は、結合組織の治療に限定されず、移植片組織、器官、又は生体外で生産された工学組織(engineered tissue)にも広がることが認識されるであろう。
本発明の方法と装置の評価を可能にするために、ACLの軟部組織の移植片(指伸筋腱)再構成の羊モデルを利用した。修飾したACL再構成は、7頭の群が3つで21頭について行った。対照群(超音波治療行わない。)を2頭とし、実験群(1日当たり連続20分間超音波治療を行う。)を5頭とし、3,6、12週の終わりに、回収した。
この研究には、変形性関節症(OA)を自然に患うハートレー(Hartley)変形(strain)モルモットを用いた。この変形は、生後6から12ヶ月の間に、人のOAに似た変形性関節症を患う。このOAは、疾病の初期ステージでの内側脛骨プラトーに限定される。
2つの縫合糸アンカーを用いて、片側の膝蓋骨腱再構成の羊モデルを用いた。3,6,12週の時点で、5頭のパルス状の低強度の超音波で治療した動物と2頭の対照動物を用いて、全部で21頭であった。このモデルは、人間の肩の回旋腱板の修復に類似した、骨に対して平坦な腱を表すために用いた。
膝蓋骨腱−近位脛骨を回収し、48時間ホルマリン中に固定した。サンプルは、蟻酸−ホルマリン溶液で石灰質を完全に取り除いた。近位挿入は、外側から内側へ1−4で標識された4つの断片に分割した。断片は、外側から内側へ1−4で標識し、パラフィン中に埋め込み、ライカ(Leica)マイクロトームで切断した。
半月板修復の2つの羊モデルを利用した。第1のモデルでは、10頭の大人の羊について、両側性の外科手術を行った。膝関節は、前内側面の2cmの切開部からアプローチした。膝関節を90°に屈曲させ、8mmの全層切開部を、各膝関節の前内側の半月内に円周方向に形成した。それから、その裂け目を、Smith & Nephewのファーストフィックス(Fast-Fix)半月修復装置で修復した。切り口は、3−0 デキソン(Dexon)で閉じた。
Claims (50)
- 関節又はその隣接した身体部分の少なくとも一部を覆い、これに対して一定の位置に固定されるように適合した被覆部材を備え、被覆部材は、1つ以上の超音波変換器アセンブリを収容して保持するように適合した1つ以上の収容領域を備える、
関節に超音波治療を送達するために関節に対して1つ以上の超音波変換器を配置する器具。 - 被覆部材は、柔軟性布地層を備えることをさらに特徴とする請求項1の器具。
- 布地層は、関節又はその隣接した身体部分を囲む弾性素材からなることをさらに特徴とする請求項2の器具。
- 超音波変換器アセンブリは、関節又はその隣接した身体部分に対する1つ以上の一定の位置に保持されることをさらに特徴とする請求項1の器具。
- 収容領域は、被覆部材内に配置された1つ以上の変換器収容ポート、及び/又は超音波変換器アセンブリを固定するように適合した1つ以上の被覆部材アタッチメント領域を備えることをさらに特徴とする請求項1の器具。
- 超音波変換器アセンブリは、超音波変換器を収容するように適合したポートと、被覆部材アタッチメント領域に確実に取り付くように適合した1つ以上のストラップアタッチメント領域を備えるストラップを備え、それによって、超音波変換器ポートは、関節又はその隣接した身体部分に対してしっかりと配置されることをさらに特徴とする請求項5の器具。
- 治療の間に、一定の位置に関節を固定するように適合した剛性の支柱をさらに備える特徴とする請求項6の器具。
- 支柱の方向又は位置を変化させる調節機構を備えることをさらに特徴とする請求項7の器具。
- 調節機構は、固定可能な旋回軸又は蝶番を備えることをさらに特徴とする請求項8の器具。
- 関節は、膝関節であり、超音波変換器アセンブリは、関節内隙又は十字靭帯骨管に対して配置されることをさらに特徴とする請求項1の器具。
- 超音波変換器をさらに備える請求項1の器具。
- 関節又はその隣接した身体部分の少なくとも一部を覆い、これに対して一定の位置に固定されるように適合した被覆部材で、関節又はその隣接した身体部分の少なくとも一部を覆い、
疾患を有する結合組織を、結合組織の成長、治癒又は修復を促進するのに十分な周波数及び持続時間の非侵襲性で低強度の超音波にさらすことを備え、
被覆部材が、1つ以上の超音波変換器アセンブリを収容して保持するように適合した1つ以上の収容領域を備えることをさらに特徴とする、
必要としている哺乳類の結合組織の成長若しくは治癒を促進するか、又は病変を治療する方法。 - 低強度の超音波は、約1〜約2MHzの間の周波数を有することをさらに特徴とする請求項12の方法。
- 低強度の超音波は、1.5MHz程度の周波数を有することをさらに特徴とする請求項12又は13の方法。
- 低強度の超音波は、パルス状であることをさらに特徴とする請求項12の方法。
- パルス状の低強度の超音波は、約10〜約2000マイクロ秒のパルス幅を有することをさらに特徴とする請求項15の方法。
- パルス幅は、約200マイクロ秒であることをさらに特徴とする請求項15又は16の方法。
- パルスは、約0.1から約10KHzの繰り返し周波数を有することをさらに特徴とする請求項15から18のいずれかの方法。
- 繰り返し周波数は、約1KHzであることをさらに特徴とする請求項18の方法。
- 結合組織は、変形性関節症、テンドノシス、腱炎、又はこれらの組合せの結果としての変性を受けたことがあるか、受けている組織を含むことをさらに特徴とする請求項12の方法。
- 治癒は、外科手術的な組織の修復又は修正無しで促進されることをさらに特徴とする請求項12又は20の方法。
- 治療を受けている結合組織は、その結合組織上又はその近くで外科手術を受けたことがあることをさらに特徴とする請求項12の方法。
- 外科手術は、屈筋又は伸筋の腱の修復、組織の修復若しくは再成長を支持可能な足場の埋め込み、及び/又は線維軟骨の修復を含むことをさらに特徴とする請求項22の方法。
- 外科手術は、靭帯若しくは腱、又は編まれた靭帯若しくは腱の外科手術的な移動を含むことをさらに特徴とする請求項22又は23の方法。
- 足場は、細胞の浸透を可能とするのに十分に多孔性の構造を有すると共に細胞の付着及び成長を可能にするのに十分な表面を有する素材を含むことをさらに特徴とする請求項23の方法。
- 線維軟骨は、損傷を受けた外側又は内側半月、下顎半月、椎間板軟骨、及び肋骨軟骨からなる群から選択されることをさらに特徴とする請求項23の方法。
- 治療を受けている結合組織は、1つ以上の靭帯、1つ以上の腱、及び/又は筋膜を含むことをさらに特徴とする請求項12の方法。
- 治療を受けている結合組織は、人間の膝、肘、及び/又は足にあることをさらに特徴とする請求項27の方法。
- 1つ以上の靭帯は、前十字靭帯、後十字靭帯、膝靭帯、及び/又は半月大腿靭帯を含むことをさらに特徴とする請求項28の方法。
- 1つ以上の靭帯は、外側又は側副靭帯を含むことをさらに特徴とする請求項28の方法。
- 腱は、四頭筋腱、薄筋腱、縫工筋腱、半腱様筋腱、膝窩筋腱、又は大内転筋腱のうちの1つ以上の腱であることをさらに特徴とする請求項27の方法。
- 腱は、人間の肩にあることをさらに特徴とする請求項27の方法。
- 腱は、棘上筋腱であることをさらに特徴とする請求項32の方法。
- 治療を受けている結合組織は、外側又は内側半月を含むことをさらに特徴とする請求項28の方法。
- 超音波は、組織収縮処置の後に続いて結合組織に加えられることをさらに特徴とする請求項12の方法。
- 組織収縮処置は、包縫合術及び椎間板収縮からなる群から選ばれることをさらに特徴とする請求項35の方法。
- 結合組織病変は、腱炎又はテンドノシスであることをさらに特徴とする請求項12の方法。
- 結合組織は、鋭い裂け、又は慢性的な酷使による損傷を受けたことをさらに特徴とする請求項12又は37の方法。
- 病変は、テニス肘であることをさらに特徴とする請求項28の方法。
- 病変は、足底筋膜炎であることをさらに特徴とする請求項28の方法。
- 薬剤を投与することをさらに含む請求項12の方法。
- 薬剤は、薬物又は成長因子であることをさらに特徴とする請求項41の方法。
- 成長因子は、修復速度、修復品質、又は両方を高めるのに十分な量で投与されることをさらに特徴とする請求項42の方法。
- 成長因子は、形質転換成長因子βスーパーファミリー、骨形態形成タンパク質、形態形成タンパク質由来の軟骨及び成長分化因子、脈管形成因子、血小板由来の細胞成長因子(PD−ECGF)、血小板由来の成長因子(PDGF)、血管内皮成長因子(VEGF)、上皮増殖因子ファミリー、形質転換成長因子アルファ(TGFα)、血小板由来の成長因子、例えば、PDGF−A、PDGF−B、PDGF−BB、線維芽細胞成長因子、成長ホルモン(GH)、インターロイキン、結合組織成長因子(CTGF)、副甲状腺ホルモン関連蛋白(PTHrp)、自己成長因子、これらの材料の少なくとも2つの混合物からなる群から選ばれることをさらに特徴とする請求項42又は43の方法。
- 超音波は、治療される組織の皮膚の近傍に配置される複数の超音波変換器によって生成されることをさらに特徴とする請求項12の方法。
- 複数の超音波変換器は、同時又は順次に超音波を放射することをさらに特徴とする請求項45の方法。
- 組織を非侵襲性で低強度の超音波にさらすことは、必要としている哺乳類の結合組織、虚血性組織、又は移植された組織での血管新生を増加させるという結果を得ることをさらに特徴とする請求項12の方法。
- 哺乳類に、新脈管形成を促進する治療的処理を施すことをさらに含む請求項12の方法。
- 新脈管形成を促進する治療的処理は、内皮細胞成長因子(EGF)、線維芽細胞成長因子(FGF)、アンジオジェニン、形質転換成長因子β(TFGベータ)、又はプロスタグランジンを投与することを含むことをさらに特徴とする請求項48の方法。
- 治療的処理は、新脈管形成を促進して損傷後の回復、修復、又は両方の速度を高めるための結合組織の予防治療を含むことをさらに特徴とする請求項48又は49の方法。
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US10/131,784 US7789841B2 (en) | 1997-02-06 | 2002-04-24 | Method and apparatus for connective tissue treatment |
PCT/US2003/012623 WO2003090868A1 (en) | 2002-04-24 | 2003-04-24 | Method and apparatus for ultrasound treatment of connective tissue |
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- 2003-04-24 AU AU2003223711A patent/AU2003223711B2/en not_active Ceased
- 2003-04-24 BR BR0309514-2A patent/BR0309514A/pt not_active IP Right Cessation
- 2003-04-24 KR KR10-2004-7017084A patent/KR20050014811A/ko not_active Application Discontinuation
- 2003-04-24 EP EP03719910A patent/EP1496995A1/en not_active Withdrawn
- 2003-04-24 CN CN038146487A patent/CN1662280A/zh active Pending
- 2003-04-24 JP JP2003587491A patent/JP2005523132A/ja active Pending
- 2003-04-24 CA CA002483336A patent/CA2483336A1/en not_active Abandoned
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2004
- 2004-11-22 NO NO20045076A patent/NO20045076L/no not_active Application Discontinuation
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Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2011509737A (ja) * | 2008-01-15 | 2011-03-31 | インダストリー ファウンデェイション オブ チョンナム ナショナル ユニバーシティー | 二相超音波振動発生器およびled素子を備えた携帯用成長板刺激型発育促進装置 |
JP2010012218A (ja) * | 2008-06-04 | 2010-01-21 | Japan Health Science Foundation | 超音波医療装置 |
US8515524B2 (en) | 2008-06-04 | 2013-08-20 | National Cerebral And Cardiovascular Center | Extracorperal ultrasonic irradition of titanium oxide (TiO2) coated implant for angiogenesis stimulation |
JP2012507365A (ja) * | 2008-10-30 | 2012-03-29 | スミス アンド ネフュー インコーポレーテッド | 脊椎の超音波処置のための装置及び方法 |
WO2011058600A1 (ja) | 2009-11-11 | 2011-05-19 | 日本シグマックス株式会社 | Pgc-1の発現制御装置、並びに虚血性疾患の治療装置及び治療方法 |
KR20120115228A (ko) | 2009-11-11 | 2012-10-17 | 고쿠리츠다이가쿠호진 히로시마다이가쿠 | Pgc-1의 발현제어장치, 및 허혈성 질환의 치료장치 및 치료방법 |
JP5732645B2 (ja) * | 2009-11-11 | 2015-06-10 | 日本シグマックス株式会社 | Pgc−1の発現制御装置、並びに虚血性疾患の治療装置 |
JP2012000439A (ja) * | 2010-05-18 | 2012-01-05 | Asahi Irika Kk | 超音波血流促進器 |
Also Published As
Publication number | Publication date |
---|---|
US8123707B2 (en) | 2012-02-28 |
BR0309514A (pt) | 2005-02-09 |
AU2003223711A1 (en) | 2003-11-10 |
WO2003090868A1 (en) | 2003-11-06 |
CA2483336A1 (en) | 2003-11-06 |
CN1662280A (zh) | 2005-08-31 |
AU2003223711B2 (en) | 2008-01-31 |
KR20050014811A (ko) | 2005-02-07 |
US20100318003A1 (en) | 2010-12-16 |
US20030153849A1 (en) | 2003-08-14 |
NO20045076L (no) | 2004-12-23 |
US7789841B2 (en) | 2010-09-07 |
EP1496995A1 (en) | 2005-01-19 |
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