JP7366211B2 - 蒸気焼灼システム及び方法 - Google Patents
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Description
本出願は、2016年12月21日出願の米国仮特許出願第62/437,617号及び2017年7月28日出願の米国仮特許出願第62/538,517号の優先権を主張し、本明細書に両出願の全体を援用する。
経尿道蒸気送出デバイス100が、組立てられた形態で図1Aに示され、図1Bは、分解図であり、蒸気送出デバイスの再使用可能なハンドル部分102と使い捨てカートリッジ部分104を示す。蒸気送出デバイスのハンドル部分102は、管腔103と、RF発生器(図示せず)にプラグ接続される電気ケーブル106と、グリップ部分107と、洗浄、ニードルの前進/後退、RF電力のON/OFFの作動ためのトリガ108と、管腔内に配置され且つ蒸気を誘導式に生成するように構成されたRFコイル110(図示せず)と、ハンドル部分内に配置され且つ蒸気ニードルを前進させたり後退させたりするように構成されたソレノイドコイル112(図示せず)を含む。
癌治療のための蒸気は、尿道内から前立腺の周囲中葉に到達する必要があるので、蒸気ニードルは、BPH手順の場合よりも更に蒸気送出ニードルから延びる必要がある。尿道壁を貫通した展開後の蒸気ニードルの位置、及び、ニードルが完全に延長された位置を図6A及び図6Bに示す。
本発明の蒸気送出デバイスのカロリー出力は、効率係数を通じた治療送出中のRF発生器の電力入力に関連する。カロリー出力は、送出された電力がデバイスの熱サイクルに起因する成分値の変化とは独立の定数である場合、ショット毎に一貫し又は不変である。カロリー出力は、入力電力が所与の治療に対して常に同じである場合、及び、効率係数がデバイス毎に一貫している場合、デバイス毎に一貫し又は不変である。デバイス毎の一貫性又は不変性は、デバイス製造の一貫性により達成される。更に、一貫性は、入力電力が一定に保持されることを条件として、電力結合効率が100%に近づく時に改善する。換言すると、デバイスパラメータの変動は、出力に送出された一定の入力電力の割合が100%に近づく時に出力に与える影響は減少する。
蒸気コイルの出口での蒸気の温度及び蒸気コイルの温度は、システムコントローラによって連続的に測定及びモニタするのがよい。設定範囲外である温度は、蒸気コイルの損傷又は蒸気治療の不十分な送出を示す場合があり、自動停止及び是正処置に関するユーザへの案内の契機にするのがよい。例えば、温度過剰は、水ラインチューブ内のキンク又は閉塞を示す場合がある。温度不足は、RFコイルへのRF電力の損失を示す場合がある。説明するデバイスの半使い捨て設計は、使い捨てカートリッジ内の温度を測定し、送出デバイスハンドル内の無線読取り機構を通して通信される無線センサに送信する。無線手法により、ハンドル内の使い捨てカートリッジの自由回転が可能であり、これは、更なるコストを伴わない重要な臨床的特徴である。
図12は、周囲領域組織に隣接した尿道前立腺部に挿入された送出デバイスを示している。カテーテル配置は、超音波画像及び膀胱鏡カメラによって案内されるのがよく、更に、可視の目印である精丘の真後ろの周囲領域へのアクセスの位置によって案内されてもよい。最初、ニードルを、ニードル位置センサによって測定されるように、約11mmの移動距離にわたって前進させる。初期移動距離は、6~12mmの範囲であるのがよく、ニードルを尿道内層から周囲領域組織に展開しなければならない。
102 ハンドル部分
103 管腔
104 カートリッジ部分
110 RFコイル
114 細長いシャフト
116 蒸気送出ニードル
119 抵抗温度計
120 蒸気コイル
121 導電金属リング
Claims (10)
- 蒸気送出デバイスであって、
ハンドル部分と、
カートリッジ部分と、を有し、
前記ハンドル部分は、管腔と、前記管腔内に配置され且つRFエネルギの供給源に接続可能であるRFコイルを有し、
前記カートリッジ部分は、前記ハンドル部分の管腔に挿入されるように構成され、
前記カートリッジ部分は、尿道に挿入されるように構成されたシャフトと、前記シャフト内に配置された蒸気送出ニードルと、前記蒸気送出ニードル及び流体源に流体接続された蒸気コイルを含み、
前記カートリッジ部分が前記ハンドル部分の管腔の中に挿入された組立形態において、前記蒸気コイルは、前記RFコイルの中にあり、且つ、前記カートリッジ部分を、蒸気を前立腺の複数の部分に送出するように前記ハンドル部分に対して回転させることが可能である、蒸気送出デバイス。 - 前記カートリッジ部分は、前記カートリッジ部分を回転させるときに前記ハンドル部分と電気的に接触している温度計を含む、請求項1に記載の蒸気送出デバイス。
- 前記カートリッジ部分は、少なくとも1つの導電リングを含み、前記導電リングは、前記カートリッジ部分の外面の周りに延び、前記温度計に電気的に接続される、請求項2に記載の蒸気送出デバイス。
- 前記ハンドル部分は、少なくとも1つの斜めコイルを含み、前記温度計は、前記カートリッジ部分の少なくとも1つの導電リングと前記少なくとも1つの斜めコイルとの間の接触を介して、前記ハンドル部分と電気的に接触している、請求項3に記載の蒸気送出デバイス。
- 前記少なくとも1つの導電リングは、前記蒸気コイルよりも近位側にある、請求項3に記載の蒸気送出デバイス。
- 前記組立形態において、前記カートリッジ部分の長手方向軸線は、前記蒸気コイルの中央の開口の中を延びる、請求項1に記載の蒸気送出デバイス。
- 前記蒸気コイルは、前記カートリッジ部分の外面の周りに巻かれる、請求項1に記載の蒸気送出デバイス。
- 前記組立形態において、前記ハンドル部分は、前記カートリッジ部分の少なくとも一部分を全周にわたって包囲する、請求項1に記載の蒸気送出デバイス。
- 前記カートリッジ部分は、少なくとも30度回転可能である、請求項1に記載の蒸気送出デバイス。
- 前記カートリッジ部分は使い捨てである、請求項1に記載の蒸気送出デバイス。
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