JP2013505069A - 膣再構築装置及び膣再構築方法 - Google Patents
膣再構築装置及び膣再構築方法 Download PDFInfo
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Abstract
Description
本願明細書において確認されるすべての公報及び特許出願は、参照によって組み込まれるように、それぞれの公報又は出願が、具体的に且つ個々に示されているような範囲でそれらの全部において、参照によって組み込まれている。
組織温度も調整されることができるので、アプリケータチップの温度を制御することによって、印加エネルギーが制御される。迅速な冷却が好ましく、装置は、効率的に且つ速やかに用いられることが可能である。しかしながら、また、冷却剤を節約しつつ冷却剤の経路を制御して、手で持つことが可能なアプリケータを効率的に利用することは、有益である。このように、本願明細書において記載されている装置は、冷却剤の節約とアプリケータの迅速且つ完全な冷却とのバランスがとれるように構成される。例えば、装置は、アプリケータ面(例えば、エネルギー運搬面)の一面の大部分をカバーする スプレーパターンを有する複数のノズルを備えているように構成されることができる。内部チップチップ内のスプレーパターンの配布を最大にして、ノズルの数を最小化することができる。加えて、アプリケータチップ及びハンドル部領域は、一つ以上の封止部と迅速な接続/迅速な解放可能なコネクターとを含む冷却戻りチャンネル及び冷却運搬チャンネルを含むことができる。ハンドヘルド領域(hand-held region)は、一つ以上の冷却運搬チャンネルと冷却戻りチャンネルとを含むこともできる。一つ以上の冷却運搬チャンネル及び冷却戻りチャンネルは、チップ冷却運搬(tip coolant delivery)及び冷却戻りのチャンネルと対をなす。冷却剤戻り経路は、装置を貫通して近位に延在することができて、患者から近位に位置する解放場所に漏れ出る(vent)ことができる。例えば、冷却戻りチャンネルは、最近位排出のため(for proximal venting)、アプリケータの近位端でのケーブル又はコネクターを貫通して延びることができる。幾つかの変形例において、冷却戻りチャンネルは、冷却剤の捕獲のための冷却剤リサイクラーと接続する。冷却剤リサイクラーは、冷却剤を後の再利用及び/又は処分のために集めるように構成されることができる。それは、冷却剤を再利用している構成要素(例えば圧縮器、その他)を含むことができる。
接触部位は、治療チップの治療表面の寸法と一致する。一回の治療は、例えばある診療所に訪問して受けることができ、典型的に複数の接触部位が治療されることができる。手順の間、単一の接触部位は、複数回接触されることができる。粘膜の接触部位を総合計すると、治療領域となる。複数の接触部位から成るこのような領域は、格子(grid)上に記録されることができる。本方法は、複数の場合に適用され得る。前回の治療の効果が評価されることができるとき、後日患者は彼女の医師を再び訪問することができ、治療が繰り返される。別々の治療の治療領域は、同じであったも良く、異なっても良く、また重複してもよい。
(1)治療チップ及びそのシャフトの一次軸に対してエネルギー運搬素子の側面に面した方向
(2)近位端から遠位端までの治療チップの全長
(3)周囲構造と隣接する平面にあるよりはむしろエネルギー運搬素子を前方へ周囲構造から突出させるチップの狭い部分24
(4)平坦なエネルギー運搬素子30の場合、膣壁との実質的に平坦な接触を可能とさせるエネルギー運搬素子の表面寸法、特に幅
(5)湾曲面を有するエネルギー運搬素子を備える実施形態の場合、エネルギー運搬素子と膣壁との間に特に密な係合が達成可能である。このような列挙されたすべての特徴は、エネルギー運搬面と粘膜上皮との間における均一に分散された接触に関係する。そのような均一な係合は、上皮を損傷させることができる端付勢接触(edge-biased contact)の可能性を低減させ、エネルギー運搬素子が上皮と接触すると共にエネルギーを下にある標的組織へ照射する部位の領域全体におけるエネルギーの均一な配布を肯定的に促進する。表面積全体におけるフラックスの均一性は、有利な均一性、整合性及び再構築反応の予測性を促進する。更に、フラックスにおける等しく重要で小さな変動は、上皮又は標的組織に対する損傷の発生を最小化する。その損傷は、エネルギーフラックスにおける大きな逸脱(large excursions)が、該大きな逸脱が必然的にそうするように、エネルギーフラックスの高い割合(high rates of energy flux)を受信する領域を含むときに、発生する場合がある。
これらの寸法の考慮点は、治療の実施形態のための正当性の基礎をなす。
そこにおいて、エネルギー運搬素子の表面は、約30度の湾曲を有し、各接触部位は、300度の弧の約10%を占めている。
Claims (48)
- 女性の生殖組織の粘膜上皮の下にある組織内の治療領域を再構築する装置であって、
両手内に保持されるように構成される細長いハンドル部と、
前記細長いハンドル部に着脱自在に連結するように構成される治療チップであって、縦軸を有するシャフトと、上皮―接触表面を有するエネルギー運搬素子と、前記エネルギー運搬素子を内部的に冷却するように構成された内部冷却室と、を有する治療チップと、
を備え、
前記エネルギー運搬素子が、標的組織を加熱するためにRPエネルギーを伝達する間に、前記上皮の冷却が可能となるように構成された熱伝導性表面を備える装置。 - 前記エネルギー運搬素子が前記シャフトの前記縦軸と実質的に平行となるように構成された、請求項1に記載の装置。
- 前記エネルギー運搬素子が約0.75cm〜約1.25cmの幅を有するように構成された、請求項1に記載の装置。
- 前記エネルギー運搬素子が約1cm〜約3cmの長さを有するように構成された、請求項1に記載の装置。
- 前記エネルギー運搬素子が平坦となるように構成された、請求項1に記載の装置。
- 前記内部冷却室が、前記エネルギー運搬素子の内部部分上に冷却液体を噴霧するように構成された複数の冷却ノズルを備える、請求項1に記載の装置。
- 3つの冷却ノズルを備える請求項6に記載の装置。
- 前記エネルギー運搬素子が少なくとも一つのRF電極を備える、請求項1に記載の装置。
- 前記ネルギー運搬素子の付近に配置された少なくとも一つの温度センサーを更に有する、請求項1に記載の装置。
- 患者から遠ざかる方向に使用冷却剤を導くように構成された前記細長いハンドル部から近位に延在する戻り冷却剤経路を更に備える、請求項1に記載の装置。
- 前記ハンドル部を統合型のコントローラに接続するフラット・ケーブルを更に備え、
前記ケーブルが、冷却剤運搬チャンネル及び冷却剤戻りチャンネル、少なくとも一つのRF電力線を含む、請求項1に記載の装置。 - 前記ハンドル部は、RFエネルギーの印加を制御するボタン又はスイッチを含まない、請求項1に記載の装置。
- 女性の生殖組織の粘膜上皮の下にある組織内の治療領域を再構築するシステムであって、
両手内に保持されるように構成される細長いハンドル部であって、長手方向に延在する細長いハンドルハンドル部と、
着脱自在に前記細長いハンドル部に連結されるように構成された治療チップであって、上皮―接触表面を有する複数のエネルギー運搬素子と、前記エネルギー運搬素子を内部的に冷却するように構成された少なくとも一つの内部冷却室と、を備える治療チップと、
を備え、
前記エネルギー運搬素子が、
前記標的組織を加熱するRFエネルギーを伝達する間に、前記上皮の冷却を可能とするように構成される熱伝導性表面と、
ハウジングと、前記ハウジング内のRF発振器と、前記ハウジング内の冷却サブシステムと、前記治療チップの動作を制御すると共に、前記治療チップが前記標的組織と接触しているかを決定するコントローラと、を含む統合型のコントローラと、
を備えるシステム。 - 前記ハンドル部を前記統合型のコントローラに連結するフラット・ケーブルを更に備え、前記ケーブルが冷却剤運搬チャンネルと、冷却剤戻りチャンネルと、少なくとも一つのRF電力線とを備える、請求項13に記載のシステム。
- 前記統合型のコントローラに連結されるように構成されていると共に、複数のエネルギー被駆動素子によって、RFエネルギーの印加を引き起こすように構成されたフットスイッチを更に備える、請求項13に記載のシステム。
- 前記統合型のコントローラが、制御情報を表示するように構成された表示装置を更に備える、請求項13のシステム。
- 前記統合型のコントローラが、接触状況を示す前記複数のエネルギー―運搬素子の図表を表示するように構成された表示装置を更に備える、請求項13に記載のシステム。
- 前記統合型のコントローラが携帯可能である、請求項13に記載のシステム。
- 前記統合型のシステムが50パウンド未満の重さを有する、請求項13に記載のシステム。
- 組織から電気的インピーダンスを決定せずに、RFエネルギー装置の治療チップのエネルギー―運搬要素が、治療される組織と十分に連結されているかを決定する方法であって、
前記治療チップの前記エネルギー―運搬素子が最後に起動した以来の時間を決定するステップと、
前記治療チップ上の一つ以上の部位の温度を測定するステップと、
前記治療チップが最後に起動した以来の時間のための閾値関数に対して前記治療チップ上の一以上の部位の温度を比較することによって、前記組織にRFエネルギーを印加せずに、エネルギー―運搬素子が前記組織と接触しているかを決定するステップと、
前記治療チップの前記エネルギー―運搬素子が、前記組織と接触してあるかを表示するステップと、
を備える方法。 - 前記閾値関数に前記治療チップ上の一以上の部位の温度を比較するステップは、前記治療チップが最後に起動した以来の約30秒から約180秒までの勾配温度閾値を有する閾値関数と比較する段階を備える、請求項20に記載の方法。
- 前記治療閾値は、前記治療チップの前記前記エネルギー―運搬素子が最後に起動した以来の限りのある時間範囲の間において、約18℃からちょうど体温の未満の温度まで徐々に増加する、請求項20に記載の方法。
- 前記治療閾値は、前記治療チップの前記エネルギー―運搬素子が最後に起動した以来の限りのある時間範囲の間において、約18℃から約27℃まで徐々に増加する、請求項20に記載の方法。
- 女性の生殖組織の粘膜上皮の下にある標的組織内の治療領域を再構築する方法であって、
アプリケータにおける内部ルーメンから前記アプリケータの処分可能な前記治療チップを冷却するステップであって、前記処分可能な治療チップが、一つ以上の非侵襲的なエネルギー―運搬素子を含むステップと、
前記治療チップを用いて前記標的組織を加熱するステップと、
標的組織の前記治療領域を再構築するステップと、
を備える方法。 - 前記一つ以上の非侵襲的なエネルギー―運搬素子の上又は付近の前記治療チップの部分の温度と、前記治療チップが最後に起動した以降の時間とに基づいて、前記組織と、前記一つ以上の非侵襲的なエネルギー―運搬素子との接触を確認するステップを更に備える、請求項24に記載の方法。
- 前記接触を確認するステップは、エネルギーを印加することなく、接触を確認する段階を備える、請求項24に記載の方法。
- 前記治療チップを冷却するステップが、前記治療チップの内部表面に対する前記内部ルーメン内に冷却剤を噴霧する段階を備える、請求項24に記載の方法。
- 冷却剤を再利用するステップを更に有する、請求項27に記載の方法。
- 前記治療チップを両手内に保持されるように構成された前記アプリケータの細長いハンドル部に接続するステップを更に備える、請求項24に記載の方法。
- 前記標的組織を加熱するステップが、前記治療チップからのエネルギー印加によって、約45℃と約80℃との間の温度まで前記標的組織を加熱する段階を備える、請求項24に記載の方法。
- 前記治療チップを前記上皮に接触させることによって、前記上皮を冷却するステップを更に備える、請求項24に記載の方法。
- 約0℃と約10℃との間の温度まで前記上皮を冷却するステップを更に備える、請求項24に記載の方法。
- 前記冷却は、前記加熱に先行して行われ、該加熱の間に持続する、請求項24に記載の方法。
- 前記冷却は、前記加熱の間に行われ、前記加熱の後に持続する、請求項24に記載の方法。
- 治療の間に、一つ以上の接触部位で前記上皮を前記治療チップと接触させるステップを備え、
エネルギー運搬素子を備える前記治療チップが、前記標的組織を加熱するのに適応している、請求項24に記載の方法。 - 女性生殖器が、外陰部及び膣を含む、請求項24に記載の方法。
- 女性生殖器が、イントロイトゥスを含む、請求項24に記載の方法。
- 女性生殖器がイントロイトゥスから該イントロイトゥスの内側へ約1cmから中で約3.5cmまでの位置まで延在する膣の一部分を含む、請求項24に記載の方法。
- 女性生殖器が、約1時から約11時まで該女性の生殖組織の壁の円周周囲の膣の一部分を含み、
尿道に最も近い態様は12時にある、請求項24に記載の方法。 - 女性生殖器が、イントロイトゥスからハートの線に外側へ放射状に広がる部分を含む、請求項24に記載の方法。
- 女性生殖器が、小陰唇の粘膜表面を含む、請求項24に記載の方法。
- 前記標的組織が、粘膜上皮の下の粘膜下組織及び筋層を含む、請求項24に記載の方法。
- 前記加熱が前記生殖組織の粘膜上皮を実質的には変更しない、請求項24に記載の方法。
- 再構築するステップが前記標的組織を収縮させる段階を備える、請求項24に記載の方法。
- 再構築するステップがイントロイトゥスを引き締める段階を備える、請求項24に記載の方法。
- 再構築するステップが膣を引き締める段階を備える、請求項24に記載の方法。
- 再構築するステップがコラーゲンを変性させる段階を備える、請求項24に記載の方法。
- 再構築するステップが、前記標的組織におけるコラーゲンの豊富な部位を引き締める段階を備える、請求項24に記載の方法。
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JP2016536073A (ja) * | 2013-11-11 | 2016-11-24 | ジョイラックス インコーポレイテッド | 家庭用の膣再活性化のための発光ダイオードおよびマッサージデバイス |
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JP2021503359A (ja) * | 2017-11-17 | 2021-02-12 | シェリー トーマス, | 女性の尿失禁症及び便失禁症の治療方法及び装置 |
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