JP3741725B2 - 軟質組織の制御された収縮のための装置 - Google Patents
軟質組織の制御された収縮のための装置 Download PDFInfo
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Description
発明の分野
本発明は、一般に、軟質組織の収縮(contraction of soft tissue)に関し、特に、コラーゲン組織の解離を最小にした軟質コラーゲン組織の圧縮に関する。
関連技術の説明
末梢関節の不安定性は、長く、患者の日常活動、作業或いは運動で活動する患者に不能や機能制限をもたらす重要な要因と考えられてきた。筋骨格系の可動関節は、関節形状、靭帯及び軟質組織外被に応じて固有の安定性の程度が変化する。可動関節は、骨端部の連結部と、軟骨表面の接触を一定に維持する軟質組織嚢により囲まれたガラス質軟骨の覆いとからなる。この関節嚢は、また、関節内に、関節表面の栄養補給及び潤滑を行う滑液を維持している。靭帯は、関節の種々の動作を調節規制しつつ関節を補強し保持する、関節嚢内の又はその周囲の軟質組織濃縮体である。靭帯、関節嚢及び結合組織は、主として、コラーゲンから成る。
関節が不安定になると、その軟質組織又は骨構造は、靭帯又は嚢により通常は許容されない方向での関節表面相互の過度の移動に晒される。関節の一方の表面の位置が他方の表面に対してずれ、一定の接触が維持されたままだと、亜脱臼が生じる。関節の一方の表面が他方の表面から完全に外れて接触が無くなると、脱臼が生じる。一般的には、関節の通常呈する移動量が大きくなるほど、関節を取り囲む軟質組織外被の本質的遊離の程度も大きくなる。この結果、ある関節は、他の関節より不安定になりがちである。例えば、肩(上腕関節窩)関節は、全末梢関節中で最も移動範囲が広い。ここは、より拘束された臀部等の球窩関節と比較してその固有の弛緩の故に亜脱臼及び脱臼率が最も高い、と長く考えられてきた。
肩の不安定性は、先天的に、発生的に、或いは外傷的に生じることがあり、再発性になることも多く、外科的修復が必要となる。実際、亜脱臼及び脱臼は、よく起こることであり、毎年多数の整形外科手術の原因となっている。症状としては、痛み、不安定、虚弱、及び機能制約等がある。不安定性が深刻で再発性のものならば、機能不全及び関節炎につながることもある。病的に弛緩した軟質組織の拘束を強化する外科的試みが指向されている。これらの処置は、入院及び長いリハビリプログラムをしばしば要する切開外科的アプローチを介して実行されることが一般的である。
最近では、これらの同じ目的を達成するための内視鏡(関節鏡)技術が、種々成功裏に開発されている。内視鏡技術は、より小さな切り口を通って行うことができるので、通常痛みが少なく、また外来患者を基準に行われ、血液損失が少なく感染の危険も少ない。更に、整形的には一層受容可能な傷痕で済む。切開技術を用いる場合と比較して術後の回復も早いことが多い。しかしながら、病的弛緩組織への接近が困難であるのと、弛緩組織の締め付けと前進が臨床上どの程度必要であるのかの決定が困難であるので、嚢又は靭帯組織を関節鏡を用いて前進させ且つ締め付けることは、一層技術的に困難なことが多い。更に、前進させた或いは締め付けた軟質組織の固定を関節鏡により行うことは、切開外科的方法の場合と比較して、一層困難である。
コラーゲン結合組織は、人体内では至る所に存在し、他の組織には見られない幾つかの独特な特性を呈する。これにより、筋骨格系の一体性、外皮の弾性並びに内蔵の構造的完全性が付与される。これらは、基本的には、五つの類型のコラーゲン分子であり、類型Iは、骨、腱、皮膚その他の結合組織に最も一般的なものであり、類型IIIは、筋肉及び弾性組織に一般的なものである。
分子間交差結合は、高引張強度と相当な弾性という独自の物理的特性を有するコラーゲン結合組織を構成する。先に確認されたコラーゲンの特性は、温度上昇時におけるコラーゲン繊維の熱水収縮である。温度上昇に対するこの独特な分子反応は、コラーゲン安定化交差結合が破壊した結果であり、また、コラーゲン繊維がその元の線膨張状態の約3分の1まで即座に収縮した結果である。更に、個々の繊維の直径は、結合組織の構造的完全性を変化させることなく、4倍以上と大幅に増加する。
人体の異なる部分におけるコラーゲン結合組織の変性については、既存の文献でも議論がなされている。コラーゲンの特性についてのこの知識を有効利用した公知の技術の一つは、組織の加熱を行うために赤外線レーザエネルギを使用している。眼の角膜コラーゲン収縮手段としての赤外線レーザエネルギの使用は、米国特許第4976709号公報に記載されているようにレーザ角膜形成術で行われている。レーザエネルギ供給の部位、タイミング及び強度を制御する重要性は、周辺非目標組織に過度の損傷を与えることなく、所望の軟質組織の収縮効果を得る際の要諦として認識されている。
高周波(RF)電流は、角膜を再形成するために用いられてきた。かかる形成は、米国特許第4326529号及び4381007号公報においてドスにより報告されている。しかしながら、ドスは、角膜の再形成におけるコラーゲン組織の解離については、関心を払わなかった。
コラーゲン組織の収縮は、多くの用途で重要である。かかる用途の一つが、肩の嚢である。肩の嚢は、骨液ライニングと、三つの良く画定されたコラーゲン層とから成る。内側と外側の層の繊維は、関節窩から上腕骨までの冠状アクセス内を延びている。コラーゲンの中間層は、矢状方向に延びて他の二つの層の繊維と交差している。三層のコラーゲン繊維の相対厚さ及び混合の程度は、嚢の部位により異なる。嚢の靭帯成分は、内側層が急に厚くなり、良く組織化された粗いコラーゲン束が冠状面内で著しく増加したものとして表すことができる。
嚢は、上腕頭を支持するハンモック状の三角巾として機能する。再発性の外傷又は発達上の不安定性の病的な状態において、この嚢は、細くなり、嚢の容量は、嚢の過剰分に従属して増加する。先天的又は発達的多方向弛緩の場合、類型I乃至類型IIIコラーゲン繊維の変化率が注目されよう。これらの肩嚢において、より弾性的な類型IIIコラーゲンの高比率が記載されていた。
人体内で多数の非破壊且つ有益な構造変化及び矯正を行うべくコラーゲン繊維の被制御線形収縮を実施する方法及び装置が、望まれている。特に、肩嚢に関して、現在の外科技術は、嚢余剰分を除去し或いは靭帯複合体を締め付けるために肩嚢を切断したり前進させたりすることを含む。従って、特定の加熱量に応じたコラーゲンの特性の知識を用いて、嚢の収縮を制御することが望まれる。
発明の概要
本発明の目的は、コラーゲン軟質組織を含む組織部位に対する熱エネルギの印加及びその継続時間を制御し、コラーゲン繊維の解離及び破壊を最小にしつつコラーゲン繊維の所望の量の収縮を得る方法及び装置を提供することである。
本発明の別の目的は、コラーゲン軟質組織を含む組織に対する熱拡散を制御するために流体環境内で高周波加熱を用い、コラーゲン繊維の解離及び破壊を最小にしつつコラーゲン繊維の所望の収縮を得ることである。
本発明の更に別の目的は、高周波加熱を用いて43乃至90℃の温度分布でコラーゲン結合繊維の収縮を達成する装置を提供することである。
本発明の別の目的は、高周波加熱を用いて43乃至75℃の温度分布でコラーゲン結合繊維の収縮を達成する装置を提供することである。
本発明の別の目的は、高周波加熱を用いて45乃至60℃の温度分布でコラーゲン結合繊維の収縮を達成する装置を提供することである。
本発明の別の目的は、流体環境内で内視鏡を用いて案内されるハンドピースを介して高周波エネルギを供給し、コラーゲン組織の解離及び破壊を最小にしつつコラーゲン軟質組織の最大収縮を達成する装置を提供することである。
本発明の更に別の目的は、コラーゲン構造の解離を生じさせることなく、最大量のコラーゲン収縮を達成する装置を提供することである。
本発明の別の目的は、軟質組織を弾性的に収縮させると共に規制し且つ関節安定性を改善するために、関節のコラーゲン軟質組織に制御された量の高周波エネルギを供給する装置を提供することである。
本発明の別の目的は、肩嚢の不静定性を減少させると共に関節に対する安定性を改善する装置及び方法を提供することである。
本発明のこれらの及びその他の目的は、コラーゲン繊維を含む組織の収縮を制御するための装置により、達成される。装置は、ハンドピースと、該ハンドピースと関連した電極近位端部を有する電極と、を含む。電極の遠位端部は、コラーゲン繊維の所望の収縮を達成するために組織に制御された量のエネルギを供給する形状を有する。これは、コラーゲン繊維の解離及び破壊を最小にしつつ、達成される。
経皮的用途では、ハンドピースは、電極と共に、手術用カニューレを通って導入されるように構成されている。また、装置の一部として手術用カニューレを含むことが好ましい。この場合、手術用カニューレは、ハンドピースに取り付けられた近位端部と、体構造内に導入されるように構成された遠位端部と、を有する。電極は、手術用カニューレ内に位置決めされ、組織に熱エネルギを供給する際にカニューレの遠位端部を超えて延伸可能である。
組織に対する熱エネルギの供給は、組織を融除しないように、行うべきである。また、供給は、コラーゲン構造を解離又は破壊することなく、行われる。これは、種々の方法で達成し得るが、その遠位端部の縁部に丸みを与えた電極がこの結果を得るために好適であることが分かった。本発明は、様々な解剖学的部位に適用可能である。構造によっては、所望の部位に到達するために電極の遠位端部を撓ませる必要がある。また、電極の一方の側に絶縁層を設け、熱エネルギが、治療領域に隣接した組織ではなく目標組織にだけ供給されるようにしてもよい。
場合によっては、熱エネルギを組織に供給する電極導電面の長さを変化させ得ることが、望ましい。このため、電極の軸方向軸線に沿って移動し得る調節可能な絶縁体により、電極導電面の長さを調節する手段を構成する。
電極構造に形状記憶金属を使用することもできる。形状記憶金属の利点は、該金属に熱を加えることにより撓ませ得ることにある。これは、特に、電極の遠位端部を撓ませる場合に、有効である。
電極は、電解溶液源から電解溶液を受け取る中央内腔を含むことができる。電極の遠位端部には複数の開口部が形成され、組織に電解流体の流れを供給する。電解溶液の代わりに、電解ゲルを電極から導入してもよい。
本発明の一実施形態では、電極を組織に隣接且つ離間させて位置決めするために、電極を部分的に絶縁ハウジングで囲んでいる。絶縁ハウジングの一部は、組織上に載置され、電極を通って組織の方に導入される電解溶液用の部分ダムの等価物を形成する。絶縁ハウジングの周りには、カフが設けられる。カフ及び絶縁ハウジングは、協働して、ダムから流出する溶液を組織部位から除去するための復帰電解溶液流路を形成する。
本発明のハンドピースは、ケーブルを介して、高周波エネルギ源に接続することができる。閉ループフィードバックシステムを設け、電極上の温度センサ及び高周波エネルギ源に連結することもできる。電極の温度は監視され、高周波エネルギ源の出力を調節して、組織に供給されるエネルギ量を調節する。
本発明は、多様な解剖学的部位に対する広範な用途を有する。本発明は、関節嚢、特に肩の上腕関節窩の関節嚢のコラーゲン軟質組織の制御された収縮のために利用可能であり、少数の例を挙げれば、板ヘルニア、膝の半月軟骨、皮膚科学等の処置のために利用可能である。
本発明の一実施形態では、軟質コラーゲン組織に対する熱拡散を制御するために、流体又は塩性環境内での高周波加熱を用いている。高周波エネルギは、外科医による関節鏡観察の下で内視的に案内されるハンドピースを介して、供給することができる。43乃至90℃の温度範囲で、最大コラーゲン収縮が得られる。別の温度範囲は、43乃至75℃、及び45乃至60℃である。これ以下の温度では、コラーゲン繊維の最大熱誘導収縮は生じない。これ以上の温度では、コラーゲン繊維パターンの過度の破壊及び分解が生じる。かくして、本発明は、熱供給を所望の熱範囲内に正確に制御する方法及び装置である。この熱をコラーゲン軟質組織に供給し、軟質組織を弾性的に収縮させ且つ規制し安定性を改善している。
図面の説明
図1は、ハンドピースと電極とを有してコラーゲン繊維を含む組織の収縮を制御するための本発明の装置の斜視平面図である。
図2は、本発明に従って縁部全体に丸みが与えられた電極遠位端部の斜視平面図である。
図3は、図2の電極遠位端部の側面図である。
図4は、本発明による電極の内腔内に位置決めされた抵抗発熱体を有する撓み電極の断面図である。
図5は、ハンドピースと電極と手術用カニューレとを有してコラーゲン繊維を含む組織の収縮を制御するための本発明による装置の斜視平面図である。
図6は、本発明による図5の装置の電極遠位端部の拡大斜視平面図である。
図7は、電極の外側に位置決めされた操作ワイヤを有する本発明による電極の斜視平面図である。
図8は、内腔と電極遠位端部に取り付けられたプラグとを有する本発明による電極の断面図である。
図9は、流体が電極の内腔を通って流れる本発明による電極の断面図である。
図10は、電極の一部を取り囲む絶縁ハウジングと該絶縁ハウジングを取り囲むカフとを有する本発明による高周波電極構造の断面図である。
図11は、図10の電極構造に有効な本発明による流体制御装置のブロック図である。
図12は、ハンドピースと、電極と、電極導電面の量を変化させるために電極の表面を横切って摺動する本発明によるスリーブの斜視平面図である。
図13は、楕円形の断面と組織内の加熱領域とを有する本発明による電極の断面図である。
図14は、ハンドピースと電極と手術用カニューレと観察鏡の断面図であって、本発明により観察鏡と電極を手術用カニューレ内に位置決めした状態を示した図である。
図15は、本発明による線15−15に沿った図14の装置の断面図である。
図16は、本発明による温度センサを位置決めした電極遠位端部の斜視平面図である。
図17は、本発明による閉ループフィードバックシステムのブロック図である。
図18は、本発明による電極遠位端部に取り付けられたローラ要素の斜視平面図である。
図19は、右側上腕関節窩の関節嚢靭帯複合体の図面である。
図20は、遊離関節嚢の図面である。
図21は、関節構造に熱エネルギを供給する電極を有する本発明の装置の概略図である。
図22は、二つの脊椎骨の間に位置する円板の断面図である。
図23は、脊間板ヘルニアに熱エネルギを供給する電極を有する本発明の装置の概略図である。
好適な実施形態の詳細な説明
次に、図1を全体的に参照すると、コラーゲン繊維を含む組織の収縮制御装置の全体が、符号10で示されている。装置10は、好ましくは絶縁材料から形成された、ハンドピース12を含む。このような絶縁材料としては、種々のものが当業者には知られている。電極14は、その近位端部16がハンドピース12に関係するが、ハンドピースに直接取り付けてもよい。電極14の遠位端部18は、コラーゲン繊維を所定量だけ収縮させるように組織に制御された量のエネルギを供給する構造を有する。収縮は、コラーゲン繊維の解離と破壊を最小にするようにして、行われる。
電極14は、組織のどの部分でも「ハンギングアップ」を生じさせないで組織全体に亘り容易に移動され得るように、平坦で細長い構造を有する。電極14の一構造では、遠位端部18の縁部20は全て、図2及び図3に示すように丸みが与えられている。遠位端部18は、種々の幾何形状としてよい。そうした形状の一つは、角張った縁部の無い円板形である。電極14は、ステンレス鋼、白金その他の貴金属等を含む様々な材料から形成することができるが、それらに限定されない。電極14は、カリフォルニア州メンロパーク市のレイケム社から市販されている、チタンニッケル等の形状記憶金属から形成してもよい。図4では、電極14の内腔内に、抵抗発熱体22が位置決めされている。抵抗発熱体は、電極14に熱を伝達する適当な金属から形成することができ、これにより、電極14の温度が従来技術で周知のように形状記憶金属が撓む水準にまで達すると電極端部18が撓む。電極14の全てを形状記憶金属から形成する必要はない。電極の遠位端部18のみを形状記憶金属から形成して所望の撓みを生じさせることもできる。本明細書の後の部分でより詳細に説明するように、電極18を撓ませる別の方法もある。
ハンドピース12と電極14とを含む装置10は、手術用カニューレを通って経皮的に挿入されるように、構成されている。装置10を非経皮的にも使用し得ること、並びに本発明の広範な用途では手術用カニューレを必要としないこと、は理解されよう。
図5及び図6に示したように、装置10は、また、一体部材として、手術用カニューレ24を含むことができる。該カニューレは、外径3乃至6ミリメートルの寸法を有して市販の手術用カニューレと同様の管状構造を有する、ハイパーダーミック・トロカールとして構成される。手術用カニューレ24は、多様な生物適合性材料から形成することができる。例えばステンレス鋼でよいが、これに限定されるものではない。
手術用カニューレ24は、ハンドピース12に取り付けられる近位端部を有し、且つ、体構造を刺通して所望の位置まで電極14を導入するための鋭い又は刺通遠位端部26を有することができる。電極14は、手術用カニューレ24の内腔内に位置決めされ、遠位端部26を越えて所望の組織部位に達するように延伸可能である。電極14は、ハンドピース12の外側に設けた展延ボタン28を作動させることにより、手術用カニューレ24に対して前進後退を行うことができる。外科医は、好ましくは展延ボタン28を摺動のみで作動させ、電極14を手術用カニューレ24の遠位端部26から離れる方向に前進させる。展延ボタン28を引き戻すと、電極14を遠位端部26の方に後退させることができる。多くの場合、電極14は、手術用カニューレ14内に完全に収容されるまで後退させる。また、電極14は、液圧装置、空気圧装置、サーボモータ、線形アクチュエータ等を用いて展延させてもよい。
ハンドピース12には、電気及び/又は流体流ケーブル28を取り付け、適当なエネルギ源及び/又は電解溶液又は電解ゲル等の流体源に対する装置10の必要な接続を行う。電解溶液は、本発明のために、電極14から組織への熱エネルギの伝達を増加させるものである。適当な電極溶液としては、食塩水があるがこれに限定されるものではない。
本発明の場合、コラーゲン繊維を含む組織に熱エネルギを伝達するために、種々のエネルギ源を使用することができる。このようなエネルギ源としては、高周波、マイクロ波、超音波、可干渉性光、及び熱伝達等があるが、これらに限定されるものではない。
高周波エネルギ源を使用した場合、外科医は、ハンドピース12及び電極14に関係した足元スイッチ30を用いて、エネルギ源を作動させることができる。重要なことは、熱エネルギが組織中に広範囲に行き亘り且つコラーゲン繊維の解離又は破壊が生じないように熱エネルギを効果的に組織に伝達すべく、制御された量の高周波エネルギが供給されることである。
多くの用途では、電極遠位端部18を撓ませる必要がある(図6)。これは、形状記憶金属を使用して行うか、或いは、機械的に行うことができる。電極14の外側又は内側には、操作ワイヤその他の機械的構造が取り付けられる。外科医は、ハンドピース12上に設けられた撓みボタン32を作動させて操作ワイヤ34をぴんと張り(図7)、電極14を後退させて電極遠位端部18を撓ませる。操作ワイヤ34の代わりに別の機械的構造を使用してもよいことは理解されよう。撓みは、組織部位への接近が困難な場合や、非線形組織の周囲での移動が必要な場合に、望ましい。電極遠位端部18を撓ませることにより、より均一な熱エネルギを組織部位に加えることが可能となり、コラーゲン材料の剥離や解離の可能性が減少する。
図7に示したように、操作ワイヤ34は、電極14の外側に形成された平面部に取り付けられる。電極14上に平面部を形成するためには、ワイヤEDM(放電加工)技術を使用することができる。図7には、T字形の棒形状が示されている。T字形棒を形成するために、化学エッチングを用いてもよい。操作ワイヤ34は、実際のワイヤである必要はない。ケブラ等の引張強さが大きいコードであってもよい。操作ワイヤ34は、ステンレス鋼製のフラットワイヤ、シート材料等から形成することができる。
電極14は、中央内腔を有する実質的に管状のものでよい。電極遠位端部18には、溶接、電子ビーム、レーザ等により電極遠位端部18に封止される導電性プラグを設けてもよい。
図9において、電極14には、処置されない組織部位の損傷を最小限にするために、電極14の裏側に電気絶縁層38を形成することができる。例えば、密な部位に電極14を導入して該部位の一方の表面のみを処置したい場合には、他の組織部位領域に熱エネルギを供給することは避けることが望ましい。絶縁層38を設けることにより、これが可能となる。適当な絶縁材料としては、ポリイミド樹脂、エポキシワニス、PVC(ポリ塩化ビニル)等があるが、これらに限定されるものではない。電極14は、絶縁層38を含まない導電性表面40を有する。
電極14の内腔から組織部位に流体流44を導入するために、電極14内に、複数の開口部42を形成している。流体は、電解溶液又はゲルでよい。例えば食塩水でよいが、これに限定されるものではない。電解液は、電極14と被加熱組織との間に効果的な電気経路を構成して両者を接触せしめる。
図10を参照すると、電極14は、電解源から電解溶液44を受け取る中央内腔を含む。電解溶液44は、電極14から導電性表面40内に形成された複数の開口部42を通って流れる。導電性表面40のみを露出させるように、電極14の周りに絶縁ハウジング46を設けている。絶縁ハウジング46は、種々の非導電性材料から形成することができる。例えば、熱可塑性樹脂、熱硬化性樹脂、セラミック等があるが、これらに限定されるものではない。絶縁ハウジング46は、被処置組織の表面に沿って載置され、導電性表面40を組織に対して隣接且つ離間させた状態で位置決めする。このように、導電性表面40は組織と直接接触せず、コラーゲン繊維の解離又は破壊の可能性が減少する。絶縁ハウジング46は、組織に隣接した電解溶液の部分的なダム48を形成する。電気エネルギは、電極14から電解溶液44に供給され、更にダム内の電解溶液44から組織に供給される。絶縁ハウジング46の周りには、カフ50が設けられる。カフ50は、熱可塑性、熱硬化性プラスチック樹脂、セラミック等を含む種々の材料から形成されるが、これらに限定されるものではない。絶縁ハウジング46及びカフのそれぞれの寸法は、特定の用途に応じて異なることができる。例えば、経皮的用途の場合、皮膚科学等の局部的用途の場合より、寸法は小さい。
カフ50と絶縁ハウジング46とは、互いに接近して位置決めされるが、電解溶液の戻り溝52を形成する程度に離間される。使用済みの電解溶液は、関節等の囲まれた体部位内に解放してもよいし、また、組織に復帰させる代わりに除去してもよい。
導電性表面40に直接接触させる代わりに冷たい溶液を介して熱エネルギを組織に伝達することにより、組織内での熱勾配をより平坦にすることができる。これにより、表面の過熱を避けることができる。従って、組織には、より均一なレベルの熱エネルギが加わる。電解溶液44は、約30乃至55℃の範囲で冷却してもよい。
次に図11を参照すると、電解溶液44は、保持容器54内に在り、流体導管56を通って温度調節器58まで移送される。温度調節器58は、電解溶液44を所望の温度まで冷却又は加熱する。ポンプ60は、流体導管56と関連してシステム全体に流体を移送し、ハンドピース12を通って電極14まで電解溶液44を供給している。復帰した電解溶液44は、電解溶液復帰溝52を通過して廃液容器62に排出される。電解溶液の流速は、約1cc/分以下で5cc/秒以上の範囲である。
導電性表面44として機能する電極14の領域は、電極の周りに絶縁スリーブ64(図12)を位置決めすることにより、調節することができる。スリーブ64を電極14の表面に沿って前進後退させることで、組織に対向する導電性表面44の表面積を増加させたり減少させたりすることができる。スリーブ64は、ナイロン、ポリイミド樹脂その他の熱可塑性樹脂等を含む種々の材料から形成することができるが、これらに限定されるものではない。熱エネルギを伝達するために利用可能な導電性表面44の効果は、個別に作動させ得る多重回路を持つ印刷配線回路等を含むがこれに限定されない、スリーブ64以外の装置により達成することができる。
電極14は、種々の異なる幾何形状を有することが可能である。一実施形態において、電極14は、楕円形の断面を有する(図13)。楕円の断面形により、組織と接触する導電性表面44の領域を大きくすることができる。即ち、組織のより大きな領域の加熱が可能となる。組織内の熱勾配はより平坦になり、コラーゲン繊維の解離又は崩壊が生じる可能性は減少する。
図14に示したように、手術用カニューレ24は、電極14の上方に位置決め可能な内視鏡66(図15)を含む。観察鏡66は、外科医が組織部位にエネルギを供給して組織を収縮させつつ観察し得るように、視界68を構成する。観察鏡66は、光束伝送繊維と光学的観察要素とを含むことができる。また、外科医は、関節鏡検査の視覚化により手術を観察することもできる。
次に、図16を参照すると、電極14の特に電極遠位端部18に一個以上の温度センサ70を位置決めしてもよい。温度センサ70は、熱電対、サーミスタ、或いは燐光体塗被光ファイバから構成することができる。温度センサ70は、電極14の温度を測定するために利用可能であるが、組織部位の温度を測定するために用いてもよい。
また、本発明の装置を、コラーゲン繊維の解離又は破壊を最小にしつつコラーゲン軟質組織の収縮を行うための高周波エネルギ供給装置として構成してもよい。図17に示したように、コラーゲン軟質組織の収縮を制御するための装置は、ハンドピース12、電極14、手術用カニューレ24、ケーブル28、及び高周波電源72とを含むことができる。適当な高周波電源は、市販されており、当業者には周知である。本発明の一実施形態において、高周波電源72は、約30ワットの高周波エネルギを移送する単一のチャネルを有し、継続流機能を有する。また、高周波エネルギ源72に温度センサ70を連結する閉ループフィードバックシステムを設けることもできる。組織の温度或いは電極14の温度は監視され、それに応じて高周波発生器72の出力が調節される。必要に応じて、外科医は、閉ループシステムをオーバライドすることができる。また、出力のオンオフを切り換えたり出力を調節するために、マイクロプロセッサ74を閉ループシステム内に組み込むこともできる。適当なマイクロプロセッサは、市販されており、閉ループシステムの当業者には周知である。閉ループシステムは、マイクロプロセッサ74を制御装置として機能させて、温度の監視、高周波出力の調節、結果の考察、結果の再フィード、更には出力の変調を行うように利用している。
導電性ローラ要素76は、電極遠位端部18上に任意に位置決めされている(図18)。導電性ローラ要素は、電極遠位端部18に回転可能に取り付けられ、複数の突起78を含むことができる。ローラ要素76は、突起78と共に組織部位を横切って移動して熱エネルギを伝達する。
本発明は、コラーゲン軟質組織を収縮させる方法を提供する。コラーゲン軟質組織は、コラーゲン構造の解離及び破壊を生じることなく、所望の収縮レベルまで収縮される。本発明は、肩、脊椎、整形用等に使用することができる。本発明が本明細書に特定的に記載された用途のみならず、種々の用途を有することは当業者には理解されよう。特定の用途としては、関節嚢、特に肩の上腕関節窩関節嚢、脊間板盤ヘルニア、膝関節の半月板、腸内、裂孔ヘルニア、腹壁ヘルニア、嚢懸濁、組織溶接、DRS等がある。
高周波エネルギ、熱エネルギは、コラーゲン軟質組織に伝達される。熱エネルギは、コラーゲン軟質組織に1mm以上貫入する。貫入は、約3mm程度にまで及んでもよい。電極14は、最大収縮が生じるまで連続的に、コラーゲン軟質組織を横切って移動される。一実施形態において、コラーゲン軟質組織は、休止重量の約3分の2程度に収縮される。好適な温度範囲は、約43乃至90°である。より好適な温度範囲は、約43乃至75℃である。一層好適な温度範囲は、45乃至60℃である。
本発明の特定の一実施形態において、関節嚢は、嚢不静定性を除去するように、処置される。より特定すれば、本発明は、肩の上腕関節窩の関節嚢内の軟質コラーゲン組織を収縮させるために利用される。図19には、肩の上腕関節窩の関節嚢の基本構造が示されている。
本発明の装置は、熱拡散を制御するために流体又は塩性環境内で高周波加熱を行う。高周波加熱は、約43乃至90℃、43乃至75℃、及び45乃至60℃の温度範囲でコラーゲン結合組織を収縮させるべく行われる。高周波エネルギは、関節内の流体又は塩性環境内で内視鏡により案内されるハンドピース12を介して伝達される。外科医により関節鏡を用いた視覚化が行われてもよいし、或いは、装置に観察装置を含んでもよい。本発明は、特定の熱範囲内での加熱を正確に制御して関節のコラーゲン軟質組織に熱エネルギを伝達することにより、軟質組織の弾性を収縮させ且つ規制すると共に、関節の安定性を改善する。肩に適用すると肩の上腕関節窩の関節嚢の嚢収縮が生じ、その結果、肩嚢内周部体積の収縮が生じて再発性不安定症状を矯正する。嚢収縮の程度は、手術前の症状の過酷さ及び関節鏡検査時の嚢の状態に基づいて、執刀外科医により決定される。コラーゲン収縮の最大量は、原構造の約3分の2である。
図20には、遊離嚢が示されている。本発明の組織の収縮を制御するための装置は、関節嚢に適用される(図21)。電極遠位端部18は、コラーゲン軟質組織の表面を横切って移動される。図23及び図24は、脊間板ヘルニアへの本発明の適用を示す。
以上、本発明の実施形態及び用途を図示説明してきたが、ここに開示した本発明の概念から逸脱することなく、上述したもの以外にも多くの変形例が可能である、ことは当業者には明らかであろう。従って、本発明は、添付請求項の精神を除き、制限されるものはない。
Claims (8)
- 整形組織中のコラーゲン繊維を熱的に収縮させる整形外科装置であって、
近位端部と、遠位端部と、前記遠位端部で第1の側に沿って延び、コラーゲン繊維を熱的に収縮させるためにコラーゲン組織に熱を供給するエネルギ供給表面と、前記遠位端部で反対側に沿って延びる熱絶縁層と、を備えた経皮的に挿入可能なエネルギ供給手段と、
前記近位端に結合されたハンドル手段と、
前記エネルギ供給手段に結合され、前記エネルギ供給手段にエネルギを供給するケーブル手段と、を備えたことを特徴とする整形外科装置。 - 前記遠位端部は、撓み可能な先端部を有し、前記エネルギ供給手段は、前記撓み可能な先端部を撓ませるように操作可能な撓ませ手段をさらに含むことを特徴とする請求項1に記載の整形外科装置。
- 前記エネルギ供給手段は、高周波電極手段であり、前記エネルギ供給表面は、コラーゲン組織を熱的に収縮させるためにコラーゲン組織中に高周波エネルギを供給するように構成されており、前記ケーブル手段は、高周波電極手段に高周波エネルギを供給するように構成されていることを特徴とする請求項1または2に記載の整形外科装置。
- 前記エネルギ供給手段に結合され、コラーゲン組織中に供給されるエネルギの量を制御するフィードバック制御システム手段をさらに備えることを特徴とする請求項1〜3のいずれか1項に記載の整形外科装置。
- 前記フィードバック制御システム手段は、(i)前記遠位端部に位置決めされ、コラーゲン組織を含有する組織の温度を測定する少なくとも1つの温度センサを含み、(ii)コラーゲン組織の温度を43乃至90℃まで上げるようにエネルギの供給を制御するように構成されていることを特徴とする請求項4に記載の整形外科装置。
- 前記フィードバック制御システム手段は、(i)前記遠位端部に位置決めされ、コラーゲン組織を含有する組織の温度を測定する少なくとも1つの温度センサを含み、(ii)コラーゲン組織の温度を43乃至75℃まで上げるようにエネルギの供給を制御するように構成されていることを特徴とする請求項4に記載の整形外科装置。
- 前記フィードバック制御システム手段は、(i)前記遠位端部に位置決めされ、コラーゲン組織を含有する組織の温度を測定する少なくとも1つの温度センサを含み、(ii)コラーゲン組織の温度を45乃至60℃まで上げるようにエネルギの供給を制御するように構成されていることを特徴とする請求項4に記載の整形外科装置。
- コラーゲン組織を含有する組織を観察する観察手段をさらに含むことを特徴とする請求項1〜7のいずれか1項に記載の整形外科装置。
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-
1994
- 1994-05-06 US US08/238,862 patent/US5458596A/en not_active Expired - Lifetime
-
1995
- 1995-02-16 US US08/389,924 patent/US5569242A/en not_active Expired - Lifetime
- 1995-05-05 JP JP52904795A patent/JP3741725B2/ja not_active Expired - Fee Related
- 1995-05-05 AU AU24321/95A patent/AU715173B2/en not_active Ceased
- 1995-05-05 AT AT95918355T patent/ATE206029T1/de not_active IP Right Cessation
- 1995-05-05 CA CA002188668A patent/CA2188668C/en not_active Expired - Fee Related
- 1995-05-05 DE DE69522939T patent/DE69522939T2/de not_active Expired - Lifetime
- 1995-05-05 EP EP95918355A patent/EP0760626B1/en not_active Expired - Lifetime
- 1995-05-05 WO PCT/US1995/005432 patent/WO1995030373A1/en active IP Right Grant
-
1996
- 1996-04-24 US US08/637,095 patent/US6482204B1/en not_active Expired - Fee Related
-
2005
- 2005-02-15 US US11/058,845 patent/US20060047331A1/en not_active Abandoned
- 2005-06-21 JP JP2005181120A patent/JP2005334663A/ja active Pending
Also Published As
Publication number | Publication date |
---|---|
DE69522939D1 (de) | 2001-10-31 |
JP2005334663A (ja) | 2005-12-08 |
AU715173B2 (en) | 2000-01-20 |
US5569242A (en) | 1996-10-29 |
DE69522939T2 (de) | 2002-04-04 |
JPH10504732A (ja) | 1998-05-12 |
AU2432195A (en) | 1995-11-29 |
US6482204B1 (en) | 2002-11-19 |
WO1995030373A1 (en) | 1995-11-16 |
US5458596A (en) | 1995-10-17 |
CA2188668C (en) | 1999-01-19 |
ATE206029T1 (de) | 2001-10-15 |
CA2188668A1 (en) | 1995-11-16 |
EP0760626B1 (en) | 2001-09-26 |
US20060047331A1 (en) | 2006-03-02 |
EP0760626A1 (en) | 1997-03-12 |
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