JP2021532873A - 皮膚特性を改善する方法、デバイス、及びシステム - Google Patents
皮膚特性を改善する方法、デバイス、及びシステム Download PDFInfo
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Abstract
Description
本国際出願は、引用によって本明細書にその全体が組み込まれている2018年7月31日出願の米国仮特許出願第62/712562号の利益及びそれに対する優先権を主張するものである。
本発明の譲渡人であるZeltiq Aestheticsインコーポレーテッドから入手可能な市販のCoolAdvantage Petite(商標)治療ユニットを−11℃の制御式冷却温度に設定し、ヒト被験者の皮膚上のターゲット部位の近位に35分の治療持続時間にわたって適用した。
−11℃に設定したCoolAdvantage Petite治療ユニットをヒト被験者の皮膚上のターゲット部位の近位に35分にわたって適用した。
−14℃に設定した浅い表面のためのプロトタイプアプリケータ(大腿の曲率に適合するように設計されており、Zeltiq Aesthetics・インコーポレーテッドから入手可能)の治療ユニットを1回の治療につき20分にわたって20人の被験者の皮膚上のターゲット部位の近位に適用した。
−11℃に設定したCoolAdvantage Petite治療ユニットをヒト被験者の皮膚上のターゲット部位の近位に20、35、及び60分という治療持続時間にわたって適用した。
図7に示すように、CoolAdvantage Petiteの計算上の3次元モデルを生成し、全ての関連の物理的境界条件及び初期条件と共に生体内試験に関する幾何学的立体及び組織特性を組み入れた。過渡的生体熱伝達モデリングは、市販の有限要素解析ソフトウエア(COMSOL Multiphysics v5.0、COMSOL・インコーポレーテッド、バーリントン、マサチューセッツ州)を使用して実行した。生体熱伝達モジュールを使用して、冷却温度及び治療持続時間の関数として温度分布と深度の関係を決定した。熱特性と代表的な寸法を表1に示している。
本発明の技術の様々な実施形態を上記に説明している。上述した詳細は、開示する実施形態を当業者が製造して使用することを可能にするのに十分な方式で実施形態を説明するために提供したことは認められるであろう。しかし、詳細及び利点のいくつかは、一部の実施形態を実施するのに必要でない場合がある。更に、一部の公知の構造又は機能は、様々な実施形態の関連する説明を不要に曖昧にしないように詳細に示していない又は説明していない場合がある。一部の実施形態は、本発明の技術の範囲に入る可能性があるが、図に関して詳細に説明していない場合がある。更に、様々な実施形態の特徴、構造、又は特性は、あらゆる適切な方式で組み合わせることができる。更に、当業者は、上述したものと類似の機能を実行するのに使用することができる他の技術がいくつか存在することを認識するであろう。処理又はブロックを所与の順序で提示するが、代替実施形態は、異なる順序でステージを有するルーチンを実行し、又は異なる順序でブロックを有するシステムを採用することができ、一部の処理又はブロックは、削除、移動、追加、細分化、結合、及び/又は変更することができる。これらの処理又はブロックの各々は、様々な異なる方法で実施することができる。同じく、処理又はブロックは、連続して実行されるものとして示される場合もあるが、これらの処理又はブロックは、代わりに並行に実行することができ、又は異なる時間に実行することができる。本明細書に与える見出しは便宜上のものであり、説明する技術の範囲又は意味を説明するものではない。
Claims (43)
- 被験者の1又は2以上の皮膚特性を改善する方法であって、
脂肪細胞シグナリングを変更するが皮下脂質豊富細胞の有意な破壊を生じない程度まで前記被験者の皮膚をターゲット部位で冷却する段階、
を含み、
前記脂肪細胞シグナリングの変更は、1又は2以上の皮膚特性の改善を生成する、
ことを特徴とする方法。 - 前記皮下脂質豊富細胞の10%未満が破壊されることを特徴とする請求項1に記載の方法。
- 前記皮下脂質豊富細胞の1%、2%、3%、4%、5%、又は7%未満が破壊されることを特徴とする請求項2に記載の方法。
- 前記冷却する段階は、いずれの皮膚悪影響も生じないことを特徴とする請求項1に記載の方法。
- 前記悪影響は、色素沈着過剰、色素沈着低下、不要な水疱形成、不要な瘢痕化、永久的な望ましくない変質、及び醜い傷痕から構成される群から選択されることを特徴とする請求項4に記載の方法。
- 前記脂肪細胞シグナリングの変更は、TGF−β、TNF−α、IL−1β、IL−6、MCP−1、レプチン、アディポネクチン、レジスチン、アシル化刺激タンパク質、α1酸性糖タンパク質、ペントラキシン−3、IL−1受容体アンタゴニスト、マクロファージ移動阻害因子、及びSAA3から構成される群から選択された1又は2以上のサイトカインの発現の増加をもたらすことを特徴とする請求項1に記載の方法。
- 前記発現の増加は、真皮層、皮下層、又はその両方に生じることを特徴とする請求項6に記載の方法。
- 前記脂肪細胞シグナリングの変更は、コラーゲン、エラスチン、プロテオグリカン(例えば、ヘパラン硫酸、ケラチン硫酸、及びコンドロイチン硫酸)、フィブリノーゲン、ラミニン、フィブリン、フィブロネクチン、ヒアルロナン、ヒアルロン酸、バーシカン、アグレカン、ルミカン、デコリン、グリピカン、テナシン、シンデカン、インテグリン、ディスコイジンドメイン受容体、ペルレカン、N−CAM、ICAM、VCAM、焦点接着キナーゼ、基質メタロプロテアーゼ、及びRho−キナーゼから構成される群から選択された1又は2以上の細胞外基質成分の増加をもたらすことを特徴とする請求項1に記載の方法。
- 前記1又は2以上の細胞外基質成分の増加は、表皮層、真皮層、皮下層、又はその組合せに生じることを特徴とする請求項8に記載の方法。
- 前記1又は2以上の改善された皮膚特性は、皮膚厚みの増大、新たなコラーゲン含有量の増加、皮膚の張りの増加、皮膚の滑らかさの増加、皮膚の引き締まり、真皮/表皮水和作用の増加、真皮再構成、及び線維性中隔の肥厚化から構成される群から選択されることを特徴とする請求項1に記載の方法。
- 前記冷却する段階は、前記ターゲット部位の近位に治療ユニットを適用することによって実行されることを特徴とする請求項1に記載の方法。
- 前記治療ユニットの温度が、約−18℃から約0℃であることを特徴とする請求項11に記載の方法。
- 前記冷却する段階は、前記ターゲット部位での表皮の温度を約−15℃から約5℃に下げることを特徴とする請求項1に記載の方法。
- 前記冷却する段階は、前記ターゲット部位での表皮の温度が約10分から約25分にわたって約−15℃から約5℃の温度であった後で中断されることを特徴とする請求項11に記載の方法。
- 前記冷却する段階は、前記ターゲット部位の7mm下方の皮下脂肪層の温度を約3℃よりも低く下げないことを特徴とする請求項1に記載の方法。
- 前記冷却する段階は、前記ターゲット部位の7mm下方の皮下脂肪層の温度を約3℃から約30℃に下げることを特徴とする請求項1に記載の方法。
- 前記冷却する段階は、前記ターゲット部位の7mm下方の前記皮下脂肪層の前記温度が約10分から約25分にわたって約3℃から約30℃の温度であった後で中断されることを特徴とする請求項16に記載の方法。
- 前記冷却する段階は、前記ターゲット部位の7mm下方の皮下脂肪層の温度が3℃よりも低く下がる前に中断されることを特徴とする請求項1に記載の方法。
- 前記冷却する段階は、単一治療セッション中に再加温期間によって分離されて2回又は3回以上繰り返されることを特徴とする請求項16に記載の方法。
- 被験者の1又は2以上の皮膚特性を改善する方法であって、
ターゲット部位での表皮を約−15℃から約5℃に冷却するのに十分な期間にわたって前記被験者の皮膚上の該ターゲット部位の近位に冷却要素を適用する段階であって、該冷却が、1又は2以上の脂肪細胞シグナリング事象の変更をもたらす前記適用する段階と、
前記ターゲット部位の約7mm下方の皮下脂肪層の温度が+3Cの温度よりも低く下がる前に前記冷却要素を除去する段階と、
を含むことを特徴とする方法。 - 被験者の1又は2以上の皮膚特性を改善する方法であって、
ターゲット部位での表皮を約−15℃から約5℃に冷却するのに十分な期間にわたって前記被験者の皮膚上の該ターゲット部位の近位に冷却要素を適用する段階であって、該冷却が、1又は2以上の脂肪細胞シグナリング事象の変更をもたらす前記適用する段階と、
前記ターゲット部位の下の皮下脂肪層全体の温度がそこにある皮下脂質豊富細胞の有意な破壊を生じるレベルまで低下する前に前記冷却要素を除去する段階と、
を含むことを特徴とする方法。 - 前記ターゲット部位の約7mm下方の前記皮下脂肪層の前記温度は、前記冷却要素の適用中に約3℃から約15℃に低下することを特徴とする請求項21又は請求項22に記載の方法。
- 前記皮下脂肪層全体内の前記皮下脂質豊富細胞の10%未満が破壊されることを特徴とする請求項20から請求項22のいずれか1項に記載の方法。
- 前記皮下脂質豊富細胞の1%、2%、3%、4%、5%、又は7%のいずれか未満が破壊されることを特徴とする請求項20から請求項23のいずれか1項に記載の方法。
- 被験者の1又は2以上の皮膚特性を改善するためのシステムであって、
治療ユニットと、
前記治療ユニットと通信する冷却ユニットを有し、脂肪細胞シグナリングを変更するが皮下脂質豊富細胞の有意な破壊を生じない程度まで前記被験者の皮膚をターゲット部位で冷却するように構成されたアプリケータと、
を含むことを特徴とするシステム。 - 前記治療ユニットの温度が、約−18℃から約0℃であることを特徴とする請求項25に記載のシステム。
- 前記アプリケータが前記被験者の皮膚を冷却する時に、該冷却は、前記ターゲット部位での表皮の温度を約−15℃から約5℃に下げることを特徴とする請求項25又は請求項26に記載のシステム。
- 前記アプリケータが前記被験者の皮膚を冷却する時に、該冷却は、前記ターゲット部位での表皮の温度が約10分から約25分にわたって約−15℃から約5℃の温度であった後で中断されることを特徴とする請求項25から請求項27のいずれか1項に記載のシステム。
- 前記アプリケータが前記被験者の皮膚を冷却する時に、該冷却は、前記ターゲット部位の7mm下方の皮下脂肪層の温度を約3℃よりも低く下げないことを特徴とする請求項25から請求項28のいずれか1項に記載のシステム。
- 前記アプリケータが前記被験者の皮膚を冷却する時に、該冷却は、前記ターゲット部位の7mm下方の皮下脂肪層の温度を約3℃から約30℃に下げることを特徴とする請求項25から請求項29のいずれか1項に記載のシステム。
- 前記アプリケータが前記被験者の皮膚を冷却する時に、該冷却は、前記ターゲット部位の7mm下方の皮下脂肪層の温度が約10分から約25分にわたって約3℃から約30℃の温度であった後で中断されることを特徴とする請求項25から請求項30のいずれか1項に記載のシステム。
- 前記アプリケータが前記被験者の皮膚を冷却する時に、該冷却は、前記ターゲット部位の7mm下方の皮下脂肪層の温度が3℃よりも低く下がる前に中断されることを特徴とする請求項25から請求項31のいずれか1項に記載のシステム。
- 前記アプリケータが前記被験者の皮膚を冷却する時に、該冷却は、単一治療セッション中に再加温期間によって分離されて2回又は3回以上繰り返されることを特徴とする請求項25から請求項32のいずれか1項に記載のシステム。
- 前記アプリケータが脂肪細胞シグナリングを変更する時に、1又は2以上の皮膚特性の改善が生成されることを特徴とする請求項25から請求項33のいずれか1項に記載のシステム。
- 前記皮下脂質豊富細胞の10%未満が破壊されることを特徴とする請求項25から請求項34のいずれか1項に記載のシステム。
- 前記皮下脂質豊富細胞の1%、2%、3%、4%、5%、又は7%未満が破壊されることを特徴とする請求項25から請求項35のいずれか1項に記載のシステム。
- 前記アプリケータが前記ターゲット部位で前記被験者の皮膚を冷却する時に、該冷却は、いずれの皮膚悪影響も生じないことを特徴とする請求項25から請求項36のいずれか1項に記載のシステム。
- 悪影響が、色素沈着過剰、色素沈着低下、不要な水疱形成、不要な瘢痕化、永久的な望ましくない変質、及び醜い傷痕から構成される群から選択されることを特徴とする請求項25から請求項37のいずれか1項に記載のシステム。
- 前記アプリケータが脂肪細胞シグナリングを変更する時に、該変更は、TGF−β、TNF−α、IL−1β、IL−6、MCP−1、レプチン、アディポネクチン、レジスチン、アシル化刺激タンパク質、α1酸性糖タンパク質、ペントラキシン−3、IL−1受容体アンタゴニスト、マクロファージ移動阻害因子、及びSAA3から構成される群から選択された1又は2以上のサイトカインの発現の増加をもたらすことを特徴とする請求項25から請求項38のいずれか1項に記載のシステム。
- 前記アプリケータが脂肪細胞シグナリングを変更する時に、発現の増加が、真皮層、皮下層、又はその両方に生じることを特徴とする請求項25から請求項39のいずれか1項に記載のシステム。
- 前記アプリケータが脂肪細胞シグナリングを変更する時に、該変更は、コラーゲン、エラスチン、プロテオグリカン(例えば、ヘパラン硫酸、ケラチン硫酸、及びコンドロイチン硫酸)、フィブリノーゲン、ラミニン、フィブリン、フィブロネクチン、ヒアルロナン、ヒアルロン酸、バーシカン、アグレカン、ルミカン、デコリン、グリピカン、テナシン、シンデカン、インテグリン、ディスコイジンドメイン受容体、ペルレカン、N−CAM、ICAM、VCAM、焦点接着キナーゼ、基質メタロプロテアーゼ、及びRho−キナーゼから構成される群から選択された1又は2以上の細胞外基質成分の増加をもたらすことを特徴とする請求項25から請求項40のいずれか1項に記載のシステム。
- 前記アプリケータが脂肪細胞シグナリングを変更する時に、1又は2以上の細胞外基質成分の増大が、表皮層、真皮層、皮下層、又はその組合せに生じることを特徴とする請求項25から請求項41のいずれか1項に記載のシステム。
- 前記アプリケータが脂肪細胞シグナリングを変更する時に、前記1又は2以上の改善された皮膚特性は、皮膚厚みの増大、新たなコラーゲン含有量の増加、皮膚の張りの増加、皮膚の滑らかさの増加、皮膚の引き締まり、真皮/表皮水和作用の増加、真皮再構成、及び線維性中隔の肥厚化から構成される群から選択されることを特徴とする請求項25から請求項42のいずれか1項に記載のシステム。
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-
2019
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- 2019-07-31 AU AU2019315940A patent/AU2019315940A1/en active Pending
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US11446175B2 (en) | 2022-09-20 |
EP3829496A1 (en) | 2021-06-09 |
KR20210038661A (ko) | 2021-04-07 |
CN112789013A (zh) | 2021-05-11 |
CA3107932A1 (en) | 2020-02-06 |
WO2020028472A1 (en) | 2020-02-06 |
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US20200038234A1 (en) | 2020-02-06 |
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