JP5702365B2 - 整形外科用途の超音波システム - Google Patents
整形外科用途の超音波システム Download PDFInfo
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- A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
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- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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Description
(i)ハンドルと、(ii)超音波プローブであって、ハンドルから遠方に向かって延びて遠位端において終端する長手シャフト、及び長手シャフトの遠位端の近くでその長手シャフトに取り付けられる超音波振動子を含み、超音波振動子が長手シャフトに沿って延びる(例えば、側面照射の)超音波エネルギ生成素子アレイを含む、超音波プローブと、(iii)超音波プローブに取り付けられる触覚フィーラプローブであって、超音波プローブの長手シャフトに取り付けられて、その遠位端を超えて遠方に延びる長手シャフト、及び触覚フィーラプローブの長手シャフトの遠位端をなすフィーラプローブ先端部を含む触覚フィーラプローブと、を含む医療診断用器具を提供し、
ハンドルを利用して、医療診断用器具を手で握り、所望の解剖学的部位(例えば、ヒト患者の脊椎)を基準に医療診断用器具を操作し、その操作において、超音波プローブの超音波振動子及び長手シャフトの遠位端、ならびに、触覚フィーラプローブのフィーラプローブ先端部及び長手シャフトを所望の解剖学的部位に挿入し、
所望の解剖学的部位に対して、超音波振動子の超音波エネルギ生成素子の配列を配置し、
超音波振動子の超音波エネルギ生成素子アレイを利用して、所望の解剖学的部位の二次元画像を取得し、
所望の解剖学的部位に対して、触覚フィーラプローブのフィーラプローブ先端部を配置し、
触覚フィーラプローブのフィーラプローブ先端部を利用して、所望の解剖学的部位の触覚検査を実行し、
前記2つの配置するステップと、前記2つの利用するステップとを、超音波振動子、触覚フィーラプローブの長手シャフトの遠位端、または触覚フィーラプローブの長手シャフトのフィーラプローブ先端部のいずれも所望の解剖学的部位から取り出さずに実行する。
・感度=(♯真陽性)/[(♯真陽性)+(♯偽陰性)]
・特異度=(♯真陰性)/[(♯真陰性)+(♯偽陽性)]
・陽性適中率(PPV:Positive Predictive Value)=(♯真陽性)/[(♯真陽性)+(♯偽陽性)]
・陰性適中率(NPV:Negative Predictive Value)=(♯真陰性)/[(♯真陰性)+(♯偽陰性)]
・開示した装置、システム、及び方法(椎弓根超音波)は、「従来の」椎弓根フィーラよりも高い感度及び陰性適中率を持つ。
・上記の違いは、非常に小さい破損(2.5mm対4.0mm)の場合により大きい。
・大きい破損(4.0mm)の場合、破損の検出は、椎弓根超音波システムを用いると、100%の感度及び特異度に近付く。
・開示した装置、システム、及び方法は、脊椎に椎弓根スクリューを配置したときに皮質骨に破損が生じたかどうかを特定/検出するためのふるい分け試験と、関連の診断の少なくともいずれかを容易化する。
・開示した装置、システム、及び方法によって、外科医及び他の医療従事者は、脊椎手術で椎弓根スクリューが誤配置される可能性を低減できるため、より効果的な健康管理を行える。
Claims (10)
- 医療診断用器具であって、
オペレータにより前記器具を手で握れるように構成され且つ寸法決めされた基部ハンドルと、
前記基部ハンドルから遠方に延びて遠位端において終端している長手シャフトと前記長手シャフトの遠位端の近くで前記長手シャフトに取り付けられた超音波振動子とを含む超音波プローブであって、前記超音波振動子が側面照射型の超音波エネルギ生成素子アレイを含んでいる、超音波プローブと、
前記超音波プローブに取り付けられた触覚フィーラプローブであって、前記超音波プローブの長手シャフトに取り付けられて前記超音波プローブの長手シャフトの前記遠位端を超えて遠方に延びる長手シャフトと当該フィーラプローブの長手シャフトの遠位端をなすフィーラプローブ先端部とを含む触覚フィーラプローブと、
を含み、
前記触覚フィーラプローブの長手シャフトは、前記超音波プローブの長手シャフトから遠方に向って前記触覚フィーラプローブの長手シャフトに沿って延びる少なくとも第1の長手方向軸線と、前記触覚フィーラプローブの長手シャフトに沿って前記フィーラプローブ先端部まで延びる第2の長手方向軸線と、前記第1と第2の両方の長手方向軸線で第1平面を画定するようにこれらの軸線の間に形成される屈曲部と、を有し、
前記超音波プローブの長手シャフトは、前記ハンドルから遠方に向って前記超音波プローブの長手シャフトに沿って延びる第3の長手方向軸線を有し、前記超音波エネルギ生成素子アレイ内の複数の超音波エネルギ生成素子は、前記超音波エネルギ生成素子アレイが延びる第4の長手方向軸線を有し、前記第4の長手方向軸線が前記第3の長手方向軸線から径方向にオフセットされて、前記第3の長手方向軸線と前記第4の長手方向軸線の両方で第2平面を画定し、
前記第2平面は前記第1平面と同一の平面であり、
前記超音波振動子及び前記遠位端は、前記オペレータが所望の解剖学的部位内に前記超音波振動子及び前記遠位端を挿入できるように協働的に構成され、方向付けされ且つ寸法決めされ、超音波検出可能な解剖学的特性を検出することを目的とした前記オペレータによる目視検査のために前記オペレータが前記解剖学的部位に対応する二次元画像を取得でき、
前記触覚フィーラプローブの前記フィーラプローブ先端部及び前記長手シャフトは、前記オペレータにより前記所望の解剖学的部位内に前記触覚フィーラプローブの前記フィーラプローブ先端部及び前記長手シャフトを挿入できるように協働的に構成され且つ寸法決めされ、前記オペレータの手により前記所望の解剖学的部位の触覚検査を実行でき、
前記所望の解剖学的部位は、ヒト患者の脊椎に形成される椎弓根スクリューパイロット孔であり、
前記超音波振動子の超音波エネルギ生成素子アレイは、前記椎弓根スクリューパイロット孔の側面壁の選択部位に沿って軸方向に延び且つ当該選択部位に対して配置され、
前記フィーラプローブ先端部は、前記椎弓根スクリューパイロット孔の側面壁の前記選択部位に対して配置される、医療診断用器具。 - 前記超音波プローブ及び前記触覚フィーラプローブを前記所望の解剖学的部位の軸方向に案内するために、前記器具を摺動可能に取り付け可能なKワイヤを収容するように構成され且つ寸法決めされる少なくとも一つのチャンネルを更に含み、前記チャンネルは、前記ハンドルに形成されてその内部を通って延びるチャンネル及び前記ハンドルの延長部に形成されてその先に延びるチャンネルのうちのいずれかである、請求項1に記載の医療診断用器具。
- 前記ハンドル及び前記超音波プローブの長手シャフトは、互いに一体化された構造である、請求項1に記載の医療診断用器具。
- 前記ハンドルはハウジングを含み、前記超音波プローブは、当該超音波プローブの長手シャフトが、前記ハンドルのハウジングによって片持ち方式で支持されるように、前記ハンドルに搭載される、請求項1に記載の医療診断用器具。
- 前記触覚フィーラプローブは、当該触覚フィーラプローブの長手シャフトが、前記超音波プローブの長手シャフトによって片持ち方式で支持されるように、前記超音波プローブに取り付けられる、請求項1に記載の医療診断用器具。
- 前記触覚フィーラプローブの長手シャフトと前記超音波プローブの長手シャフトとの間に、少なくとも部分的な長手方向の重複が存在する、請求項1に記載の医療診断用器具。
- 前記複数の超音波エネルギ生成素子は、リニアアレイ及びフェイズアレイのうちの一方である、請求項1に記載の医療診断用器具。
- 前記超音波エネルギ生成素子アレイにおける前記超音波プローブの長手シャフトに沿った軸方向長さが、約8ミリメートルから約12ミリメートルの間である、請求項1に記載の医療診断用器具。
- 前記超音波プローブの長手シャフトの前記遠位端よりも遠方に延びる前記触覚フィーラプローブにおいて、前記触覚フィーラプローブの長手シャフト及び前記フィーラプローブ先端部の両方にわたって前記側面照射型超音波エネルギ生成素子アレイより先の前記触覚フィーラプローブの軸方向長さが、約8ミリメートルから約12ミリメートルの間である、請求項1に記載の医療診断用器具。
- 前記フィーラプローブ先端部は球状先端部である、請求項1に記載の医療診断用器具。
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PCT/US2010/033873 WO2010129773A1 (en) | 2009-05-07 | 2010-05-06 | Ultrasound systems and methods for orthopedic applications |
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EP2427117A4 (en) | 2015-11-11 |
US8343056B2 (en) | 2013-01-01 |
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