JP2020512917A - 眼レーザー手術及び治療処置のためのシステム及び方法 - Google Patents
眼レーザー手術及び治療処置のためのシステム及び方法 Download PDFInfo
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Abstract
Description
[0001] 本明細書に記載される主題は、概して、レーザー強膜マイクロポレーション用のシステム、方法、治療及び装置に関し、より詳細には、眼の組織のレーザー強膜マイクロポレーション若返り用の、具体的には結合組織の老化に関する、眼又は強膜若返りによる結合組織の若返り用のシステム、方法及び装置に関する。
[0002] 眼は、視覚機能及び眼生体輸送に関与する複雑な筋肉、排出、及び体液機構を含む複雑な感覚器である生体力学的(biomechanical)構造物である。調節系が眼器官における主要な可動システムであり、眼の多くの生理学的及び視覚的機能を促進している。調節系の生理学的役割は、眼器官の周りで水、血液、栄養素、酸素、二酸化炭素、及び他の細胞を移動させることである。一般に、老眼者の調節能力の喪失は、加齢の影響を受ける多々の水晶体要因、並びに水晶体外及び生理学的要因が原因となる。加齢に伴う眼硬性の増加によってこれらの眼構造に応力及び歪みが生じるとともに、調節能力が影響を受けることもあり、これは、いくつか例を挙げれば、視覚調節、房水流体力学、硝子体流体力学及び眼拍動血流を含め、生理学的過程の生体力学的効率が低下する形で眼に影響し得る。現行の手技では、屈折矯正レーザー手術、適応光学系、又は角膜若しくは眼内インプラントによるなど、眼の一つの光学系の屈折力を交換する何らかの人工的手段によって光学系を操作するに過ぎず、他の光学系及び調節機構(accommodative mechansim)の生理学的機能を維持する重要性は無視される。
[0005] 眼の組織の若返り用の、具体的には結合組織の老化に関する、強膜若返りによる結合組織の若返り用のレーザー強膜マイクロポレーションのためのシステム、装置及び方法が開示される。本明細書に開示されるシステム、装置及び方法は、眼の自然の調節に関連する自然の生理学的及び生体力学的現象を通じて生理学的調節又は生理学的偽調節を回復することを含め、眼の生理学的機能を回復させる。
[0012] 本明細書に示される主題の詳細は、その構造及び動作の両方に関して、添付の図を検討することにより明らかになり得る。図では、同様の参照符号は同様の部分を指す。図中の構成要素は必ずしも一定の縮尺とは限らず、むしろ主題の原理を例示することに強調が置かれている。更に、例示は全て、概念を伝えることが意図され、ここでは関連性のあるサイズ、形状及び他の詳細な属性が、文字どおりに又は正確にというよりむしろ、概略的に例示され得る。添付の図面中に例示されるのは、本発明の最良の実施態様のうちの少なくとも1つである。
[00105] 以下に記載する図は、記載される発明及びその好ましい最良の実施態様の少なくとも1つの使用方法を示し、最良の実施態様については以下の説明において更に詳細に定義する。当業者は、本明細書に記載されるものに対し、その趣旨及び範囲から逸脱することなく変形及び改良を加えることが可能であり得る。本発明は多くの異なる形での実施形態が可能であるが、本開示は本発明の原理の例示と見なされるべきで、本発明の幅広い態様を例示の実施形態に限定することは意図されないという理解の下、本発明の好ましい実施形態が図面に示され、ここに詳細に説明されることになる。本明細書に提供される任意の実施形態に関連して説明される全ての特徴、要素、構成部品、機能、及びステップは、自在に組み合わせることが可能であり、特に指定されない限り、任意の他の実施形態からのものに代替可能であることが意図される。従って、例示されるものは、あくまでも例を目的として記載されることが理解されなければならず、本発明の範囲の限定と解釈されてはならない。
中心角=360/n度(式中nは辺数である)。
これを簡約すると、以下となる:
[00168] 現在の調節理論には、我々が読み取ることを可能にする屈折変化に主として水晶体が関与すると唱えるものもあるが、毛様小体器の全ての要素が関わることが分かっている。水晶体外過程が調節において果たす役割の解明は、本来硬性の組織に対する伸展性の回復によって生体力学的特性を改変する強膜治療が老眼者の調節能力に影響を与え得るという理論を裏付ける。
[00228] プロトコル1.1:225μm(総数96孔@3%=24孔/象限:有効)
[00229] スポットサイズ:225um;深さ:80%;密度:3%;除去容積:0.91mm3;細孔総数全体:96;細孔総数/象限:24
[00230] プロトコル1.2:225μm(総数161孔@5%=40.25孔/象限:有効)
[00231] スポットサイズ:225um;深さ:80%;密度:5%;除去容積:1.52mm3;細孔総数全体:161;細孔総数/象限:40.25
[00232] プロトコル1.3:225μm(総数257孔@8%=64.25孔/象限:有効)
[00233] スポットサイズ:225um;深さ:80%;密度:8%;除去容積:2.43mm3;全体の細孔総数:257;細孔総数/象限:64.25
[00234] プロトコル1.4:225μm(総数565孔@10%=141.25孔/象限:有効)
[00235] スポットサイズ:225um;深さ:80%;密度:10%;除去容積:3.04mm3;全体の細孔総数:565;細孔総数/象限:141.25
[00236] プロトコル2.1:250μm(総数100孔@3%=25孔/象限:有効)
[00237] スポットサイズ:250um;深さ:80%;密度:3%;除去容積:0.91mm3;全体の細孔総数:100;細孔総数/象限:25
[00238] プロトコル2.2:250μm(総数166孔@5%=41.5孔/象限:有効)
[00239] スポットサイズ:250um;深さ:80%密度:5%;除去容積:1.52mm3;全体の細孔総数:166;細孔総数/象限:41.5
[00240] プロトコル2.3:250μm(総数265孔@8%=66.25孔/象限:有効)
[00241] スポットサイズ:250um;深さ:80%;密度:8%;除去容積:2.43mm3;全体の細孔総数:265;細孔総数/象限:66.25
[00242] プロトコル2.4:250μm(総数332孔@10%=83孔/象限:有効)
[00243] スポットサイズ:250um;深さ:80%;密度:10%;除去容積:3.04mm3;全体の細孔総数:332;細孔総数/象限:83
[00244] プロトコル3.1:325μm(総数59孔@3%=14.75孔/象限:有効)
[00245] スポットサイズ:325um;深さ:80%;密度:3%;除去容積:0.91mm3;全体の細孔総数:59;細孔総数/象限:14.75
[00246] プロトコル3.2:325μm(総数98孔@5%=24.5孔/象限:有効)
[00247] スポットサイズ:325um;深さ:80%;密度:5%;除去容積:1.52mm3;全体の細孔総数:98;細孔総数/象限:24.5
[00248] プロトコル3.3:325μm(総数157孔@8%=39.25孔/象限:有効)
[00249] スポットサイズ:325um;深さ:80%;密度:8%;除去容積:2.43mm3;全体の細孔総数:157;細孔総数/象限:39.25
[00250] プロトコル3.4:325μm(総数196孔@10%=49孔/象限:有効)
[00251] スポットサイズ:325um;深さ:80%;密度:10%;除去容積:3.04mm3;全体の細孔総数:196;細孔総数/象限:49
[00252] プロトコル4.1:425μm(総数34孔@3%=8.5孔/象限:有効)
[00253] スポットサイズ:425um;深さ:80%;密度:3%;除去容積:0.91mm3;全体の細孔総数:34;細孔総数/象限:8.5;
[00254] プロトコル4.2:425μm(総数57孔@5%=14.25孔/象限:有効)
[00255] スポットサイズ:425um;深さ:80%;密度:5%;除去容積:1.52mm3;全体の細孔総数:57;細孔総数/象限:14.25
[00256] プロトコル4.3:425μm(総数92孔@8%=23孔/象限:有効)
[00257] スポットサイズ:425um;深さ:80%;密度:8%;除去容積:2.43mm3;全体の細孔総数:92;細孔総数/象限:23
[00258] プロトコル4.4:425μm(総数115孔@10%=28.75孔/象限:有効)
[00259] スポットサイズ:425um;深さ:80%;密度:10%;除去容積:3.04mm3;全体の細孔総数:115;細孔総数/象限:28.75
[00260] fibonacci_spiral_connected_Pantec(‘r’,0.225,3,6.62,9.78)>>1.1
[00261] fibonacci_spiral_connected_Pantec(‘r’,0.225,5,6.62,9.78)>>1.2
[00262] fibonacci_spiral_connected_Pantec(‘r’,0.225,8,6.62,9.78)>>1.3
[00263] fibonacci_spiral_connected_Pantec(‘r’,0.225,10,6.62,9.78)>>1.4
[00264] fibonacci_spiral_connected_Pantec(‘c’,0.125,3,6.62,9.78)>>2.1
[00265] fibonacci_spiral_connected_Pantec(‘c’,0.125,5,6.62,9.78)>>2.2
[00266] fibonacci_spiral_connected_Pantec(‘c’,0.125,8,6.62,9.78)>>2.3
[00267] fibonacci_spiral_connected_Pantec(‘c’,0.125,10,6.62,9.78)>>2.4
[00268] fibonacci_spiral_connected_Pantec(‘c’,0.1625,3,6.62,9.78)>>3.1
[00269] fibonacci_spiral_connected_Pantec(‘c’,0.1625,5,6.62,9.78)>>3.2
[00270] fibonacci_spiral_connected_Pantec(‘c’,0.1625,8,6.62,9.78)>>3.3
[00271] fibonacci_spiral_connected_Pantec(‘c’,0.1625,10,6.62,9.78)>>3.4
[00272] fibonacci_spiral_connected_Pantec(‘c’,0.2125,3,6.62,9.78)>>4.1
[00273] fibonacci_spiral_connected_Pantec(‘c’,0.2125,5,6.62,9.78)>>4.2
[00274] fibonacci_spiral_connected_Pantec(‘c’,0.2125,8,6.62,9.78)>>4.3
[00275] fibonacci_spiral_connected_Pantec(‘c’,0.2125,10,6.62,9.78)>>4.4
[00408] 様々な実施形態において、眼科レーザーシステムは、レーザービーム送出システムと、レーザービーム送出システムと共に動作可能な眼の移動に応答する視標追跡器とを含み、眼の強膜の選択範囲にレーザービームショットを当てることによって前部及び/又は後部の両方の眼の強膜材料をアブレーションする。ショットは、レーザーショットが連続した位置に発射されないように、及び連続したショットが重ならないように順番にパターンで発射される。パターンは眼の移動に応じて動かされる。眼の強膜は「軸外」であるため、このスキャニング機構は、眼の視軸へのビームの固定によって動作するのでない点で新規である。図20、図20(A〜C)を参照すると、むしろ「軸外」スキャニング機構は、ゴニオメトリックミラー又はガイダンスシステムを利用して視軸外にある強膜の反対の象限をアブレーションする眼用ドッキングシステム2000を必要とする。閉ループフィードバックシステムがスキャナの内側に、及びまた眼用ドッキングシステムとスキャナとの間にも磁気センサ機構の形態で位置し、これらは両方ともレーザーヘッドを眼用ドッキングシステムにロックし、及びバイオフィードバックおかげで眼が位置決めされて、視標追跡及びビーム送出の両方が作動する。
[00424] 図20Jは、眼内の房水流路を示す。房水流出は、毛様体筋及び小柱網細胞の能動的収縮によって調節され得る。毛様体筋が収縮すると小柱網が拡張し、流出が増加してIOPが低下する。小柱網細胞が収縮すると流出が減少してIOPが上昇する。一部の実施形態において、記載されるシステムは毛様体筋の動力学の改善を生じさせ、房水排出の流体力学を改善し得る。
[00458] 事実上全ての組織において、疾患の進行は機械的特性の変化を伴う。レーザースペックルレオロジー(LSR)は、本発明者らが組織の機械的特性を測定するために開発した新しい技法である。試料をコヒーレントレーザー光で照射し、反射したレーザースペックルパターンからのスペックル輝度変調を計算することにより、LSRは強度無相関の減衰時定数τを計算し、これは組織の機械的特性と密接に関連している。LSR技術の使用は、組織の機械的特性を測定することによりバリデートすることができる。τのLSR測定が種々のファントム及び組織試料で実施され、レオメーターを使用して測定した複素剪断弾性率G*と比較される。いずれの場合にも、τとG*との間には強い相関が認められる(r=0.95、p<0.002)。これらの結果は、生体試料の機械的評価のための非侵襲及び非接触技術としてのLSRの有効性を実証している。
[00463] 組織及び基質のバルク機械特性は、卓上LSRセットアップを用いて測定される。このセットアップは、複数のコヒーレンスレーザー長のレーザーと、それに続く直線偏光子及びビーム拡大器を含む。焦点距離レンズ及び平面鏡を使用して照射スポットを標的組織領域に集束させる。高速CMOSカメラを使用してレーザースペックルパターンが撮像される。画像系列が処理され、各2フレーム間の相関を計算することにより強度無相関関数g2(t)が決定される。画像系列ピクセルに時間及び空間平均化が適用され、統計誤差が低減される。得られたg2(t)曲線に単一指数関数がフィッティングされ、時定数τが抽出される。
処置表面積=処置が施された強膜の表面積(mm^2)、ここで処置表面積=アレイの二乗。
厚さ=処置範囲の強膜の厚さ(mm)、均一と仮定
処置容積=処置が施された強膜の容積(mm^2)
処置容積=処置表面積×厚さ=アレイ2×厚さ
密度%=処置表面積のうち細孔が占める割合(%)
スポットサイズ=1つの細孔の表面積(mm^2)
#細孔=処置領域内にある細孔の数
総細孔表面積=処置表面積内の細孔が占める総面積
深さ=1つの細孔の深さ(mm);細孔当たりのパルス(ppp)パラメータに依存する 深さ%=厚さのうち細孔深さが延びる割合(%)。
図26 3−Aに示されるとおり、総細孔容積=処置表面積内の細孔が占める総面積
容積分率=処置容積のうち細孔が占める割合(%)、即ちレーザーによって除去された強膜容積の割合
容積分率=処置容積のうち細孔が占める割合(%)、即ちレーザーによって除去された強膜容積の割合。
剛性=治療前の強膜の弾性係数(MPa)
処置剛性=治療後の強膜の弾性係数(MPa);マイクロスケール混合モデルから推定
強膜剛性のみ**処置した全ゾーン領域(領域分率=1)
プロトコル=可能な密度%と深さとの組み合わせの範囲、全てのゾーンの強膜が細孔容積分率に応じた処置剛性に変化した
容積分率が調節における毛様体の変形に及ぼす効果:強膜剛性+付着**処置した全ゾーン領域(領域分率=1)***健常=元の調節モデル結果
プロトコル=可能な密度%と深さとの組み合わせの範囲、全てのゾーンの強膜が細孔容積分率に応じた処置剛性に変化した 容積分率が調節における毛様体の変形に及ぼす効果:強膜剛性+処置範囲形状
プロトコル=可能な密度%と深さとの組み合わせの範囲、全てのゾーンの強膜が細孔容積分率及び処置面積の領域分率に応じた処置剛性に変化
Claims (30)
- マイクロポレーションによる医学的処置を送達して生体力学を改善するためのシステムであって、
生体力学を改善するアレイパターンのマイクロ細孔を作り出すために、表面下アブレーションによる医学的処置における使用に動作可能な、患者の視軸と整列しない処置軸上でレーザー放射ビームを発生させるためのレーザー;
ハウジング;
前記ハウジング内にあり、前記レーザーと通信しており、且つ標的組織への適用に際して前記レーザー放射ビームの線量測定を制御するように動作可能な、制御器;
前記レーザー放射ビームを標的組織に集束させるように作動可能なレンズ;
自動化された軸外表面下解剖学的構造追跡、測定及び回避システム
を含み;及び
前記マイクロ細孔のアレイパターンが、放射パターン、螺旋パターン、葉序パターン、又は非対称パターンのうちの少なくとも1つである、システム。 - 前記マイクロ細孔のアレイパターンが、アルキメデスの螺旋、オイラーの螺旋、フェルマーの螺旋、双曲螺旋、リチュース、対数螺旋、フィボナッチの螺旋、黄金螺旋、又はこれらの組み合わせの螺旋パターンである、請求項1に記載のシステム。
- 前記マイクロ細孔のアレイパターンが、制御された非対称性を有する、請求項1に記載のシステム。
- 前記制御された非対称性が、前記アレイパターンの中心に対する少なくとも部分的な回転非対称性である、請求項3に記載のシステム。
- 前記マイクロ細孔のアレイパターンが、制御された対称性を有する、請求項1に記載のシステム。
- 前記制御された対称性が、前記アレイパターンの中心に対する少なくとも部分的な回転対称性である、請求項5に記載のシステム。
- 前記アレイパターンが複数の右回り螺旋と複数の左回り螺旋とを有する、請求項1に記載のシステム。
- 右回り螺旋の数及び左回り螺旋数が、フィボナッチ数又はフィボナッチ数の倍数である、請求項7に記載のシステム。
- 右回り螺旋の数及び左回り螺旋の数が、黄金比に収束する比である、請求項7に記載のシステム。
- 前記少なくとも部分的な回転非対称性が前記アレイパターンの前記マイクロ細孔の少なくとも51パーセントに及ぶ、請求項4に記載のシステム。
- 前記少なくとも部分的な回転非対称性が前記アレイパターンの少なくとも20個のマイクロ細孔に及ぶ、請求項4に記載のシステム。
- 前記少なくとも部分的な回転対称性が前記パターンの前記マイクロ細孔の少なくとも51パーセントに及ぶ、請求項6に記載のシステム。
- 前記少なくとも部分的な回転対称性が前記アレイパターンの少なくとも20個のマイクロ細孔に及ぶ、請求項6に記載のシステム。
- 前記マイクロ細孔のアレイパターンがランダム非対称性を有する、請求項1に記載のシステム。
- 前記マイクロ細孔のアレイパターンがランダム対称性を有する、請求項1に記載のシステム。
- 生体力学を改善するためマイクロポレーションによる医学的処置を送達する方法であって、
生体力学を改善するマイクロ細孔アレイを作り出すため、レーザーにより、表面下アブレーションによる医学的処置において患者の視軸と整列しない処置軸上に処置ビームを発生させること;
前記レーザーと電気的に通信している制御器により、標的組織への適用に際して前記処置ビームの線量測定を制御すること;
レンズにより、前記処置ビームを前記標的組織に集束させること;
自動化された軸外表面下解剖学的構造追跡、測定、及び回避システムにより、前記処置ビームを適用する眼位置をモニタすること
を含み;及び
前記マイクロ細孔のアレイパターンが、放射パターン、螺旋パターン、葉序パターン、又は非対称パターンのうちの少なくとも1つである、方法。 - 前記マイクロ細孔のアレイパターンが、アルキメデスの螺旋、オイラーの螺旋、フェルマーの螺旋、双曲螺旋、リチュース、対数螺旋、フィボナッチの螺旋、黄金螺旋、又はこれらの組み合わせの螺旋パターンである、請求項16に記載の方法。
- 前記マイクロ細孔のアレイパターンが、制御された非対称性を有する、請求項16に記載の方法。
- 前記制御された非対称性が、前記アレイパターンの中心に対する少なくとも部分的な回転非対称性である、請求項18に記載の方法。
- 前記マイクロ細孔のアレイパターンが、制御された対称性を有する、請求項16に記載の方法。
- 前記制御された対称性が、前記アレイパターンの中心に対する少なくとも部分的な回転対称性である、請求項20に記載の方法。
- 前記アレイパターンが複数の右回り螺旋と複数の左回り螺旋とを有する、請求項16に記載の方法。
- 右回り螺旋の数及び左回り螺旋の数が、フィボナッチ数又はフィボナッチ数の倍数である、請求項22に記載の方法。
- 右回り螺旋の数及び左回り螺旋の数が、黄金比に収束する比である、請求項22に記載の方法。
- 前記少なくとも部分的な回転非対称性が前記アレイパターンの前記マイクロ細孔の少なくとも51パーセントに及ぶ、請求項19に記載の方法。
- 前記少なくとも部分的な回転非対称性が前記アレイパターンの少なくとも20個のマイクロ細孔に及ぶ、請求項19に記載の方法。
- 前記少なくとも部分的な回転対称性が前記パターンの前記マイクロ細孔の少なくとも51パーセントに及ぶ、請求項21に記載の方法。
- 前記少なくとも部分的な回転対称性が前記アレイパターンの少なくとも20個のマイクロ細孔に及ぶ、請求項21に記載の方法。
- 前記マイクロ細孔のアレイパターンがランダム非対称性を有する、請求項16に記載の方法。
- 前記マイクロ細孔のアレイパターンがランダム対称性を有する、請求項16に記載の方法。
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US20210338484A1 (en) | 2021-11-04 |
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IL269740A (en) | 2019-11-28 |
CA3058461A1 (en) | 2018-10-04 |
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