JP2010046483A - 生検マーカー送達装置 - Google Patents

生検マーカー送達装置 Download PDF

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JP2010046483A
JP2010046483A JP2009191710A JP2009191710A JP2010046483A JP 2010046483 A JP2010046483 A JP 2010046483A JP 2009191710 A JP2009191710 A JP 2009191710A JP 2009191710 A JP2009191710 A JP 2009191710A JP 2010046483 A JP2010046483 A JP 2010046483A
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cannula
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Andrew P Nock
アンドリュー・ピー・ノック
Ramon Ramos
ラモン・ラモス
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
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    • AHUMAN NECESSITIES
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    • A61B2090/3904Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
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    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
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Abstract

【課題】生検部位に生検マーカーを送達するための生検装置を提供する。
【解決手段】生検装置は、カニューレ12の遠位端部22に配された単一の末端部を有するマーカー配備器具を含み得る。遠位末端部は、成型された部品であり得、遠位先端部、マーカー配備ランプ210、およびマーカー係合要素240を含んでおり、このマーカー係合要素は、マーカー300が配備されようとするまで、カニューレ12内にマーカー300を維持するのを助ける。
【選択図】図2

Description

開示の内容
〔背景〕
生検標本は、様々な医療処置において様々な仕方で、様々な装置を使用して入手されてきた。生検装置の例は、オハイオ州シンシナティのEthicon Endo-Surgery社のMAMMOTOME(登録商標)という銘柄の装置である。生検装置は、定位ガイド(stereotactic guidance)、超音波ガイド、MRIガイドなどのもとで使用されてよい。
さらなる例示的な生検装置は、「Method and Apparatus for Automated Biopsy and Collection of Soft Tissue」と題する1996年6月18日発行の米国特許第5,526,822号、「Control Apparatus for an Automated Surgical Biopsy Device」と題する2000年7月11日発行の米国特許第6,086,544号、「MRI Compatible Surgical Biopsy Device」と題する2003年6月12日公開の米国特許公開第2003/0109803号、「Remote Thumbwheel for a Surgical Biopsy Device」と題する2007年5月24日公開の米国特許公開第2007/0118048号、「Biopsy System」と題する2006年12月13日出願の米国仮特許出願第60/869,736号、「Biopsy Sample Storage」と題する2006年12月13日出願の米国仮特許出願第60/874,792号、および、「Revolving Tissue Sample Holder for Biopsy Device」と題する2007年11月21日出願の米国特許出願第11/942,785号に、開示されている。上記に引用した米国特許、米国特許出願公開、米国仮特許出願、および米国特許出願の各々の開示内容は、参照によって本明細書に組み込まれる。
いくつかの状況では、生検部位の場所を、将来的な参照のために標識することが望ましい場合がある。例えば、組織標本が生検部位から採取される前、最中、または、採取された後に、1つ以上のマーカーが、生検部位に沈着されてよい。例示的なマーカー配備用具には、オハイオ州シンシナティのEthicon End-Surgery社のMAMMOMARK(登録商標)、MICROMARK(登録商標)、およびCORMARK(登録商標)という銘柄の装置が含まれる。生検部位の標識のためのさらなる例示的な装置および方法は、「Marker Device and Method of Deploying a Cavity Marker Using a Surgical Biopsy Device」と題する2005年10月13日公開の米国特許公開第2005/0228311号、「Imageable Biopsy Site Marker」と題する2006年2月7日発行の米国特許第6,996,433号、「Tissue Site Markers for In Vivo Imaging」と題する2006年1月31日発行の米国特許第6,993,375号、「Tissue Site Markers for In Vivo Imaging」と題する2006年5月16日発行の米国特許第7,047,063号、「Methods for Marking a Biopsy Site」と題する2007年6月12日発行の米国特許第7,229,417号、「Devices for Defining and Marking Tissue」と題する2006年5月16日発行の米国特許第7,044,957号、「Devices for Marking and Defining Particular Locations in Body Tissue」と題する2001年5月8日発行の米国特許第6,228,055号、および、「Subcutaneous Cavity Marking Device and Method」と題する2002年4月16日発行の米国特許第6,371,904号に、開示されている。上記に引用した米国特許および米国特許出願公開の各々の開示内容は、参照によって本明細書に組み込まれる。
カニューレタイプの配備器具から生検部位へとマーカーを配備することが望ましい場合がある。マーカーは、配備器具から不用意に外れてはならず、マーカーを配備するための力は、過剰であってはならない。
本発明は、添付の図面と合わせて考慮される、以下における、ある例の説明から、より適切に理解されるであろうと確信される。図面における同一の参照符号は、同じ要素を特定している。
〔詳細な説明〕
以下における本発明のある例の説明は、本発明の範囲を限定するために使用されるべきではない。本発明の他の例、特徴、態様、実施形態および利点が、以下の説明から、当業者には明らかとなるだろう。以下の説明は、例証としての、本発明を実施するために意図される最適な様態のうちの1つである。認識されるであろうように、本発明は、全て本発明を逸脱することなしに、他の異なる明白な態様が可能である。したがって、図面および説明は、例証的な性質のものであり、制限的なものではないとみなされるべきである。
図1は、細長い外側カニューレ12を含むマーカー送達装置10を図示しており、この細長い外側カニューレ12は、カニューレ12の遠位端部の近くに形成されているもののカニューレ12の遠位端部から近位側に離間した、側部開口14などのマーカー出口を有する。
グリップ16が、カニューレ12の近位端部に提供され得る。プッシュロッド18が提供され得、このプッシュロッド18は、カニューレ12内を同軸的に延び、よって、プッシュロッド18は、カニューレ12の内部を並進移動して側部開口14を通して1つ以上のマーカーを転置するよう構成される(図2を参照)。ロッド18は、マーカーをカニューレ12の内腔から開口14を通して押し出すために十分な圧縮剛性(rigidity in compression)を有し得るが、湾曲に関して相対的に可撓性であり得る。カニューレ12内でロッド18を遠位側に押しやるために、プランジャー20がロッド18の近位端部に提供されて、マーカーをカニューレ12の外に配備することができる。
ユーザーは、2本の指でグリップ16を握ってよく、同じ手の親指を使用してプランジャー20を押してよく、よって、マーカー送達装置10は、ユーザーの一方の手で作動され得る。バネ(不図示)または他の特徴部がロッド18の周りに提供されて、グリップ16およびカニューレ12に対して近位側にロッド18を付勢してよい。
図2は、本発明の一実施形態によるマーカー送達装置10の遠位部の断面図を表す。図2は、カニューレ12の内腔15内に配された生検マーカー300を示す。マーカー300は、概して円筒形状のコラーゲン本体など、生物分解可能な、または別様に吸収可能な本体306、および、本体306の内部に配されるか、または別様に本体306によって保持される金属性の、概して放射線不透過性のマーカー要素310(透視図で示す)、を具備し得る。
カニューレ12は、いかなる適する金属材料または非金属材料で形成することもできる。一実施形態では、カニューレ12は、適する医療用プラスチックまたはポリマーで形成された薄壁中空チューブで形成される。適する一材料は、例えばPEBAXという商品名で知られるポリエーテルブロックアミド(PEBA)などの熱可塑性エラストマーである。カニューレ12は、PEBAXで形成され得、可視光線およびx線に対して実質的に透明であり得る。
側部開口14は、カニューレ12の壁の一部を切り取ることによって形成され得る。側部開口14は、カニューレの内腔15と連絡している。側部開口14は、図2に図示されるように、近位開口端部14Aから遠位開口端部14Bへと、軸方向に(腔15の軸に平行な方向に)延び得る。
カニューレ12の遠位端部から延びる遠位先端部22は、図2に示されるように、丸くされ得る。図2を参照すると、本発明のマーカー送達装置は、カニューレ12の遠位端部の所定の位置に形成された単一の末端部21によって閉じられる、カニューレ12の遠位端部を有し得、末端部21の一部分は、カニューレの内腔15の中に延びている。遠位末端部21は、成型または鋳造された部品であり得、先端部22、ランプ面212を有するランプ210、およびマーカー係合要素240の一体型に形成された組み合わせを提供し得る。ランプ面212は、マーカー300を内腔15から側部開口14を通り抜けるように方向付けるのを助ける。マーカー係合要素240は、ユーザーがマーカーを配備しようとするまで、マーカー300を内腔15内に維持するのに役立つ。
マーカー係合要素240は、内腔15の内部に配され、マーカー係合要素の少なくとも一部は、側部開口14の近位端部14Aの遠位側に配される。マーカー係合要素240は、開口14の下のカニューレ15の床の一部に沿って延び得、マーカー係合要素240は、開口14が形成されているカニューレの一部を補強するよう位置付けられ得る。例えば、図2に示されるように、開口14の真下にマーカー係合要素240を位置付けることによって、要素240は、カニューレ12の壁が開口14を形成するために切断されている領域で、カニューレ12を強化するのに役立ち得る。
図2に示される実施形態では、マーカー係合要素240は、ランプ面212の最近位部から延び、側部開口14の近位側には延びないが、他の実施形態では、要素240の一部が、開口14の近位側に延び得る。
図2に示される実施形態では、マーカー係合要素240は、要素の軸方向長さに沿って、概して一定の厚さTを有する段の形態であるが、例外として、要素は、先細状の近位端部242を有する。先細状の近位端部242は、腔15の長さ方向軸に対して約45°の夾角(図2の平行線に対する夾角)を形成し得、一方、ランプ面212は、長さ方向軸に対して約30°の夾角を形成し得る。
厚さTは、カニューレ12の壁厚tより厚くすることができ、一実施形態では、Tは厚さtの少なくとも約2倍である。一実施形態では、厚さTは、約0.018インチ〜約0.040インチ(約0.457mm〜約1.016mm)であり得、壁厚tは、約0.005インチ〜約0.008インチ(約0.127mm〜約0.203mm)であり得る。腔15の内径は、約0.120インチ(3.048mm)であり得る。
図2の実施形態では、マーカー係合要素240の上向き面244(開口14に向いた面)は、遠位側に延びてランプ面212に接し、よって、面244とランプ面212との間には空間も間隙もない。このような配列は、マーカー300が、マーカー係合要素を過ぎて動く際に、マーカー係合要素とランプとの間でつかえるかもしれない可能性を削減するのに有利である。
本発明の一実施形態によると、マーカー係合要素240、ランプ210、および/または先端部22は、カニューレ12の壁より相対的に放射線不透過性が高い材料で形成され得るか、またはそのような材料を含み得る。例えば、要素240、ランプ210、および先端部22が、一体型の末端部21として形成される場合、末端部21は、硫酸バリウムなど放射線不透過性添加剤を含み得る。例えば、末端部21は、溶融したPEBAX成型組成物に添加された硫酸バリウムを約20重量%だけ備える、PEBAXで成型された部品であり得る。
相対的に放射線不透過性が高いマーカー係合要素240、ランプ210、および先端部22は、レントゲン撮影法を使用してこれらの部品の位置を識別するのに有用であり得る。また、ランプおよび/または係合要素の段が、開口14に関連して位置付けられている場合、放射線不透過性材料の添加は、マーカー配備の前、最中、または後に、開口の位置、および開口に対するマーカー300の位置を特定するのに役立ち得る。
図面では、腔15に配された1つのみのマーカーが示されている。しかしながら、複数のマーカーが、端と端をつないだ構成などで、マーカー送達装置10に配され得ることが理解されるだろう。マーカーは、同じサイズおよび形状を有するか、または代替的に、異なるサイズおよび/または形状を有し得る。
カニューレ15は、可視光線およびx線に対して、概して透明であり得、末端部21は、可視光線およびx線に対して、概して不透明であり得る。所望される場合、末端部21は、液体成型組成物中の染料または他の適する着色料で着色され得る。例えば、異なる生検処置のために、異なるサイズのマーカー(例えば長さおよび/または直径)を有することが望ましい場合がある。例えば、相対的に大きな生検標本が採取される場合は大きなマーカーを、また、相対的に小さな生検標本が採取される場合は小さなマーカーを提供することが望ましい場合がある。末端部21は、カニューレに配されるマーカーのサイズを表示するために複数の色のうちの1つを使用して着色され得る。例えば、3つのマーカーサイズが提供される場合、末端部21は、3つの色のうちの1つで着色され得、特定のマーカー装置のカニューレにどのマーカーサイズが配されるかを特定することができる。末端部21はまた、マーカー送達装置で使用されるべき、特定のサイズ(直径または長さ)の生検針を表示するために着色され得る。加えて、複数のマーカー送達装置が、キットの形態で梱包され得、キットには、異なるサイズのマーカーと、対応する着色された末端部とを有するマーカー送達装置が含まれる。
図3を参照すると、マーカー送達装置10は、患者の内部の特定の場所を標識するようマーカーを配備するために使用されてよい。図3には、カニューレ生検針1000が示されている。針1000は、穿通先端部1002を備えた閉じた遠位端部、および、側方組織受容孔1014を有して、示されている。マーカー配備器具10は、生検針1000を通って生検部位に導入されてよく、この生検針は、生検部位から組織標本を採集するのに使用されるものと同じ針であり得る。生検針1000は、一回の挿入で、複数の標本を得る、真空補助生検装置(single insertion, multiple sample vacuum assisted biopsy devices)で使用されるタイプのものであり得る。いくつかのこのような生検装置は、参照されかつ参照によって本明細書に組み込まれる、様々な特許および特許出願で開示されているが、他の生検装置が使用されてもよい。
図3は、針1000の内部に配されたマーカー配備器具10の遠位端部を示している。針1000は組織に位置付けられ得、生検標本が開口1014を通して入手され得、それによって、開口1014に隣接した生検空洞をもたらす。次に、組織標本が入手されて針を通して近位側に移送された後、針1000を患者の組織から除去することなく、配備器具10が針1000の近位開口の中に挿入され得る。図3では、針1000および配備器具10は、カニューレ12の開口14および針1000の開口1014が実質的に軸方向および円周方向に整列するように、位置付けられている。次に、配備器具および針が生検部位でそのように位置付けられた状態で、プッシュロッド18が前進させられて、マーカーを、ランプ面212の上方、開口14、次いで開口1014を通して、生検空洞の中に配備することができる。
図4〜図6は、マーカー送達装置10と共に使用され得る放射線不透過性マーカー要素の説明を提供する。図4は、チタンなどの放射線不透過性材料の概して平坦なブランク(blank)310Aを図示しており、この平坦なブランク310Aは、第1の相対的に大きな部分312、第2の相対的に大きな部分314、ならびに、第1の部分312および第2の部分314を接続する相対的に狭い部分316を有するように、切断され得るか、または別様に形成され得る。ブランク310Aは、第1の側部315および第2の側部317を有し得る。
部分312および314は、概して円形の突出部(lobe)として示されているが、正方形、長方形、三角形、楕円形など他の形状も用いられ得る。3次元マーカー要素310(図2に示される生物吸収可能(bioresorbable)な本体306内に位置付けられ得るような)を形成するために、2つの突出部312および314は、図5の矢印によって表示されるように、軸318の周りで反対の方向にねじられ得る。2つの突出部312および314は、それらの間の角度319(図6に見られるような)が、約45°〜約135°となるように、ねじられ得る。結果として生じる3次元放射線不透過性マーカー要素310は、図6に示されるように、端部で見たときに、概してx形状の構成を有することになる。概して平坦な部分312および314は、互いに対して面外に(out of plane)ねじられるので、部分312および314は、x線を含む様々な撮影方法において、様々な方向(例えば、上、底、横、端部)からより容易に見られることができる。図5および図6に示される3次元マーカー要素310は、次に、生物吸収可能な本体306(図2)の中に挿入されるか、または、別様に本体306によって保持されて、吸収可能な本体および放射線不透過性マーカー要素を有するマーカー300を提供することができる。
図7は、カニューレ12の遠位端部の単一の末端部21を射出成型するために使用され得る組立体を図示している。組立体は、鋳型空洞4020を有する鋳型部分4000を含み得、この鋳型空洞4020は、図2の丸くされた、概して半球形の先端部21に対応する、丸くされた面4021を含む。カニューレ12は、図7に示されるように、空洞4020内に位置付けられ得る。概して円筒形の外側面を有する成型コア部品5000が、図7に示されるように、カニューレ12の内腔の内部に位置付けられ得る。部品5000は、端部面5212、5244、および5242を有し得、これらはそれぞれ、ランプ面212、段面244、および先細状端部面242に対応する。PEBAXおよび放射線不透過性添加剤を具備する溶融した組成物が、次に、空洞4020の中に射出され得、よって、末端部21が、カニューレ12の遠位開口の所定の位置に形成される。
本明細書に開示される装置の実施形態は、概して、一度使用された後、廃棄されるように設計されるが、複数回使用されるように設計されることもできる。マーカーを形成し、配備器具の中にマーカーを挿入した後、生検装置は、滅菌され得る。装置は、プラスチックバッグまたはTYVEKバッグなどのパッケージ内に設置され得る。
梱包された生検装置は、次に、γ放射線、x線、または高エネルギー電子などの放射線野に設置され、装置および梱包材を滅菌してよい。装置はまた、βもしくはγ放射線、酸化エチレン、または蒸気を限定することなく含めた、当業分野で既知の他のいかなる技術を使用して滅菌されてもよい。
本発明の様々な実施形態を示し説明してきたが、本明細書で説明された方法およびシステムのさらなる改作物が、本発明の範囲を逸脱することなく、当業者により適切な改変によって達成されてよい。こうした潜在的な改変のいくつかは言及されており、他の改変が当業者には明らかであろう。例えば、上記で論じられた例、実施形態、幾何学的形状、材料、寸法、比率、ステップ、および同種のものは、例証的なものであり、必須とされるわけではない。したがって、本発明の範囲は、添付の特許請求の範囲の観点から考慮されるべきであり、明細書および図面に示され説明された詳細な構造および作動に限定されるものではないことを理解されたい。
マーカー送達装置の斜視図を表す。 本発明によるマーカー送達装置の遠位部の断面図を表す。 生検部位を標識するために、配備器具から、生検針の側部組織受容ポートを通して配備されているマーカーを表す。 狭い部分で分離された2つの相対的に大きな突出部または端部を有する、チタン製の概して平坦な砕片を表し、この砕片は、放射線不透過性マーカー要素を形成するために使用され得る。 図4の平坦な砕片を、図5の矢印によって表示されるように反対方向に2つの突出部をねじることなどによって、3次元マーカー要素を提供するように形成することを表す。 図5のマーカー要素の端面図を表し、マーカー要素は、図6にあるように、端部で見たときに、概してx形状の構成を有する。 本発明の実施形態によるマーカー送達装置の遠位先端部、ランプ、およびマーカー係合要素を形成するために、カニューレの遠位開口端部に単一の末端部を射出成型するのに使用される組立体を図示している。

Claims (16)

  1. 生検マーカー送達装置において、
    カニューレであって、前記カニューレの近位端部から前記カニューレの遠位端部に延びる内腔、および、前記カニューレの前記遠位端部の近位側の、前記カニューレの側壁に形成されたマーカー出口を有する、カニューレと、
    前記カニューレの前記遠位端部を閉じる遠位先端部と、
    前記マーカー出口に隣接して位置付けられるランプと、
    前記カニューレの前記内腔の内部に配されるマーカー係合要素であって、前記マーカー係合要素の少なくとも一部が、前記マーカー出口ポートの近位端部の遠位側に配される、マーカー係合要素と、
    前記カニューレの前記内腔の内部に配される少なくとも1つのマーカーと、
    を具備する、装置。
  2. 請求項1に記載の装置において、
    前記ランプおよびマーカー係合要素は、単一の部品を構成する、装置。
  3. 請求項1に記載の装置において、
    前記ランプおよびマーカー係合要素は、前記遠位先端部と一体化している、装置。
  4. 請求項1に記載の装置において、
    前記遠位先端部、ランプ、およびマーカー係合要素は、単一の部品を構成する、装置。
  5. 請求項1に記載の装置において、
    前記遠位先端部、ランプ、およびマーカー係合要素は、単一の成型された部品を構成する、装置。
  6. 請求項1に記載の装置において、
    前記カニューレは、相対的に可撓性の薄壁チューブを具備し、
    前記マーカー係合要素は、前記内腔の内部に配される相対的に強固な部材を具備する、装置。
  7. 請求項1に記載の装置において、
    前記カニューレは、壁厚tを有し、
    前記マーカー係合要素の厚さは、tより厚い、装置。
  8. 請求項1に記載の装置において、
    前記マーカー係合要素は、軸方向長さの少なくとも一部に沿って、概して一定の厚さを有する段を具備する、装置。
  9. 請求項8に記載の装置において、
    前記マーカー係合要素は、先細状の近位端部を具備する、装置。
  10. 請求項1に記載の装置において、
    前記遠位先端部は、相対的に前記カニューレより放射線不透過性が高い、装置。
  11. 請求項10に記載の装置において、
    前記遠位先端部、ランプ、および前記マーカー係合要素は、相対的に前記カニューレより放射線不透過性が高い、装置。
  12. 請求項11に記載の装置において、
    前記遠位先端部、ランプ、およびマーカー係合要素は、放射線不透過性材料を具備する、装置。
  13. 請求項12に記載の装置において、
    前記遠位先端部、ランプ、およびマーカー係合要素は、硫酸バリウムを具備する単一の成型された部品である、装置。
  14. 請求項1に記載の装置において、
    前記マーカー係合要素は、前記マーカー出口の概しての反対側の前記内腔の床に沿って延びる、装置。
  15. 請求項1に記載の装置において、
    前記マーカー係合要素は、前記カニューレを補強するために前記カニューレに配される、装置。
  16. 生検マーカー送達装置において、
    カニューレであって、近位端部、遠位端部、前記近位端部から前記遠位端部に延びる内腔、および、前記カニューレの側壁に形成されたマーカー出口を有する、カニューレと、
    前記カニューレの前記遠位端部に配される単一の末端部であって、
    遠位先端部、
    前記遠位先端部の近位側に配されるランプであって、前記マーカー出口の遠位端部から延びるランプ面を有する、ランプ、
    前記ランプから近位側に延びるマーカー係合要素、
    を含む、単一の末端部と、
    前記カニューレの前記内腔の内部に配される少なくとも1つの生検マーカーと、
    を具備する、装置。
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