JP7021196B2 - 解剖学的検出システム誘導直腸内前立腺生検デバイス - Google Patents
解剖学的検出システム誘導直腸内前立腺生検デバイス Download PDFInfo
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Description
本願は、米国特許仮出願第62/382,631号(2016年9月1日出願。参照によりその全体が本願に援用される)の最先出願日の優先権の利益を主張する。
本発明は、国立先進トランスレーショナル科学センターによって提供された5 UL1 TR000128 10の下での政府支援によりなされたものである。
本開示は、組織生検の分野に関する。より具体的には、本開示は、前立腺組織の解剖学的検出システムでターゲットとされた生検のためのデバイス、システム、および方法に関する。
本開示に記載の医療デバイスは、遠位のハウジング部と、近位のハウジング部と、器具収束点とを有するハウジングを含み、遠位のハウジング部は、ヒトの肛門内へ挿入され、直腸で保持されるように構成され、近位のハウジング部は、可変の角度での操作のために角度方向付けシステムと収束点との間を医療器具が通り得るように角度方向付けシステムを含む。
Claims (24)
- 近位端と、遠位端と、近位のハウジング部と、中間のハウジング部と、遠位のハウジング部とを有し、前記遠位のハウジング部は前記近位のハウジング部および前記中間のハウジング部の中心線から上方に曲げられ、前記遠位のハウジング部は肛門内に挿入され、対象の直腸内に保持されるように構成され、遠位端MRIコイル区画を含むハウジングと、
収束点に近位および遠位の両方の器具の動きの範囲を定める近位の円すいおよび遠位の円すいの交点によって定められ、可変および選択可能な角度で前記器具が器具収束点を通れるように構成されている、近位端と遠位端との間に配置した器具収束点と、
前記ハウジングの近位端に、チャンネル軸のそれぞれが前記器具収束点に収束するように配向した、チャンネル軸をそれぞれ有する複数の定期的に間隔を空けた器具アクセスチャンネルを含む固定配列器具角度方向付けシステムと、
を含むことを特徴とする解剖学的検出システム誘導前立腺処置デバイス。 - 前記固定配列器具角度方向付けシステムが、前記近位のハウジング部内に配置された曲線状グリッドアレイプレートを含み、前記複数の定期的に間隔を空けた器具アクセスチャンネルが100~200個の器具アクセスチャンネルを含む請求項1に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記複数の定期的に間隔を空けた器具アクセスチャンネルが、グリッドパターンまたは同心円パターンで配向されている請求項1または2に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記複数の定期的に間隔を空けた器具アクセスチャンネルの間の間隔が、前記近位のハウジング部および前記中間のハウジング部の中心線から測定される1~5°である請求項1~3のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記複数の定期的に間隔を空けた器具アクセスチャンネルのサブセットへの前記器具のアクセスを可能にする切り抜きを含む回転可能なグリッドプレートカバーをさらに含む請求項1~4のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記器具収束点が、前記器具を三次元配置へ遠位に向けるように構成されている装置内に含まれる請求項1~5のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記固定配列器具角度方向付けシステムが、前記器具の遠位端の侵入深さおよび前記器具の遠位端の三次元の位置のうちの1つ以上を指示する請求項1~6のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 任意に実質的に円筒状であり、前記器具が前記解剖学的検出システム誘導前立腺処置デバイスを通過できるようにする器具ガイドをさらに含む請求項1~7のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記収束点が、前記解剖学的検出システム誘導前立腺処置デバイスの近位端およびデバイスの遠位端から走る軸に沿って平行移動可能である請求項1~8のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記中間のハウジング部が、前記中間のハウジング部内で回転抑制され、前記器具収束点を中心とする球状ターゲティングボールをさらに含み、任意に前記球状ターゲティングボールは、円錐状切り抜きを含む請求項1~9のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記器具ガイドが、前記球状ターゲティングボールの遠位側から伸びるか、かつ/または前記器具ガイドが、前記球状ターゲティングボールの近位側から伸び、任意に前記器具ガイドが調節可能であり、前立腺に隣接した直腸の外壁に対して位置づけることができる請求項10に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 解剖学的検出システムが、磁気共鳴解剖学的検出システム、コンピュータ断層撮影(CT)解剖学的検出システム、または超音波解剖学的検出システムを含む請求項1~11のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記器具が、生検針、プローブ、センサシステム、処置デバイス、治療の器具システム、または化学物質配置デバイスを含み、前記化学物質配置デバイスは、任意に取り外し可能なマーカー、染料/造影剤、薬、または取り外し可能ではないマーカーを含む請求項1~12のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 少なくとも1つのMRIコイルをさらに含む請求項1~13のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記少なくとも1つのMRIコイルが、前記遠位端MRIコイル区画内に配置されたMRIコイルを含む請求項14に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記少なくとも1つのMRIコイルが、前記ハウジングの前記近位端の内表面上に配置されているか、または前記遠位のハウジング部および前記中間のハウジング部を横断するMRIコイルを含む請求項14に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記少なくとも1つのMRIコイルがループアンテナおよび/またはバタフライアンテナを含み、前記ループアンテナおよび前記バタフライアンテナが、位相機で90°の位相のずれで駆動されて、環状に分極した磁場を生じる請求項14~16のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記近位のハウジング部に連結したクランプハンドルおよび/または前記近位のハウジング部に連結した圧迫環をさらに含む請求項1~17のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 解剖学的検出システムに対してデバイスを位置付ける、解剖学的検出システムで検出可能な化学物質の1点以上をさらに含む請求項1~18のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記解剖学的検出システムで検出可能な化学物質の1点以上が、前記器具ガイドの遠位端、前記収束点、および/または前記固定配列器具角度方向付けシステムの中心に位置している請求項19に記載の解剖学的検出システム誘導前立腺処置デバイス。
- マッチング部品、および/またはパワースプリッター、および/または信号結合器の1つ以上をさらに含む請求項1~20のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記遠位のハウジング部が、前記器具がデバイスを通れるようにし、前記器具の動きを定める遠位の円すいに一致する切り抜きを、前記遠位のハウジング部の下面に含む請求項1~20のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 前記遠位のハウジング部が、前記ハウジングの中心線から10~60°から上方に曲げられ、ヒト直腸のJ形状に一致するように構成されているか、かつ/または前記遠位のハウジング部の遠位の表面が、肛門および直腸組織の挿入および保護を容易にするために丸みを帯びている請求項1~22のいずれか1項に記載の解剖学的検出システム誘導前立腺処置デバイス。
- 請求項1~23のいずれかに記載のデバイスと、医療処置を行う器具と、任意に解剖学的検出システムに対して固定されたデバイスを保持するように構成されたクランプとを含み、任意に前記器具は深度表示器を含む解剖学的検出システム。
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