JP2007160085A - 経皮的および裂孔的なデバイスならびに最小侵襲性骨盤外科手術における使用のための方法 - Google Patents
経皮的および裂孔的なデバイスならびに最小侵襲性骨盤外科手術における使用のための方法 Download PDFInfo
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Abstract
【解決手段】ガイド部材を身体組織に挿入するためのガイド部材配置部材であって、近位端、遠位端および通じて延びる管腔を有するシャフトであって、この管腔はガイド部材を受けるよう適合されているシャフトと、係合部材であって別のガイド部材配置デバイスと係合するためのシャフトの遠位端である係合部材を備える。このガイド部材配置部材は、シャフトの遠位端における切開鈍先端と通じて延びる管腔を有するハンドルを備えても良く、上記シャフトの近位端はこのハンドルに装着され、その結果、シャフトの管腔とハンドルの管腔とが整列する。
【選択図】図1
Description
本発明は、失禁を処置するためのデバイスおよび方法に関する。
尿失禁は、合衆国および世界中において広範囲に及ぶ問題である。尿失禁は、すべての世代の人々に起こり、且つ、生理学的および心理学的の両面で患者にシビアな影響を与え得る。
従って、尿失禁に対する処置を単純にし、且つその安全性を増大させるデバイスに対する必要性がある。デバイスの進行中に尿道を不意に挟み、且つ組織または骨の望ましくない摩損を起こす危険性を減少させる、尿失禁を処置する為のスリング適用デバイスが特に望ましい。ガイド縫合糸を用いずに、且つ直角クランプを使用することなく尿道と上部膣壁との間の組織に開口を作成および開口を維持するスリング適用デバイスを有することがまた望ましく、それによって処置かみそりが単純にされる。
本発明は、尿失禁のための経皮的および裂孔的なアプローチ処置を使用する為のデバイスおよび方法に関する。特に、本発明は、部材配置デバイス、スリング適用カテーテル、組織切開器/拡張器、スリング適用デバイスおよびスリング適用システム、組織延長器、把持デバイス、およびバルーンカテーテルを導くことに関する。尿自制を維持し、改善するための膀胱頸部または尿道床を安定化させるための前出のデバイスを用いる方法は、また開示されている。
本発明は、身体組織での開口もしくはポケットの作製、および/または身体組織の拡張のための方法およびデバイスに関する。本発明の、ガイド部材配置デバイス、スリング適用カテーテル、組織切開器/拡張器、スリング適用デバイス、スリング適用システム、脱着可能部材スリング適用デバイス、回収装置、およびバルーンカテーテルは、経皮的にまたは腹腔鏡技術と共に用いられ得る。このような腹腔鏡手順では、外套ニードルが腹部に置かれ、そして腹部はCO2を吸入され、膨張が引き起こされる。デバイスは外套ニードルを介して、患者身体内に導入され、そして処置手順は腹腔鏡を用いて可視化される。
なお別のアプローチにおいて、開口またはポケットは、鈍切開器および鋭利なカッターの組合せで、尿道と上部膣壁との間の組織を切開することによって作成される。
本発明の1つの局面は、スリングが、ガイド部材に沿って導入される方法およびこのような方法における使用のためのデバイスに関する。ガイド部材は縫合糸、ガイドワイヤ、または所望の位置へスリングをガイドするために適切な他の構造であり得る。
好ましくは、シャフトは剛性である。シャフトの近位端が、それを通って伸びる管腔を有するハンドルへ取り付けられることがまた好ましい。好ましくは、ガイド部材配置デバイスは、それを通って伸びる管腔を有する鈍切開器先端を有する。鈍切開器先端は、好ましくはシャフトの遠位端に位置される。鈍切開器先端は、シャフト内にあり、そしてシャフトから伸張可能であり、かつシャフトへ後退可能である鈍切開器上に存在することがまた好ましい。
スリングを使用する代表的な膀胱頚部安定化処置手順における図1〜7Dのガイド部材配置デバイスの使用は、以下に記述し、そして図8〜14に示す。しかしながら、ガイド部材配置デバイスがまた、ガイド部材の導入が必要な多くの他の外科的処置手順に使用され得ることを当業者は理解する。
本発明の別の局面は、患者の身体組織の開口またはポケット中にスリングを導入するための、スリング適用カテーテルである。特に、本発明のスリング適用カテーテルは、例えば、膀胱頚部安定化処置手順のような、尿道床再構築処置手順において使用され得、現在使用されている技術よりもより少ない侵襲の様式で、スリングを尿道と上部膣壁との間の組織に導入する。
ここで、袋414は、患者へのスリングの導入に先立って、袋における、天然材料で作製されたスリングの再水和およびスリングの抗生物質または生理食塩水での浸漬を可能にする孔411を有する。この実施態様においては、袋414は種々の材料、例えば、PE、PETまたはビニルで作製され得る。好ましくは、多孔性材料は、約100ミクロン〜約0.25インチの範囲の孔サイズを有する。好ましくは、袋414はビニルで作製され、0.125インチの孔サイズを有する。
本発明の別の局面は、身体組織において開口またはポケットを作製し、そして拡張可能な拡張器で開口またはポケットを拡張するための、組織切開器/拡張器510である。組織切開器/拡張器は、尿道床再構成処置手順(例えば、膀胱頸部安定化処置手順(ここで、女性(female)の尿道と膣壁上部との間の組織が切開されそして拡張されて、失禁を緩和するために設計された治療用スリングデバイスの配置を容易にする))において特定の適用を見い出す。
好ましくは、切開器は、シャフトの管腔内に存在し、そして軸方向に移動可能であり、その結果、シャフトから伸張可能であり、かつ後退可能である。好ましくは、拡張器は、膨張可能でかつ折り畳み式である。
好ましくは、シャフト530は、遠位端534に向かってカーブする。好ましくは、このカーブは、曲率半径が小さなカーブである。好ましくは、シャフトの遠位端534は、シャフトの近位部に対しておよそ90°の角度である。しかし、当業者は、シャフト530におけるカーブが、解剖学的考慮事項およびここで組織切開器/拡張器が使用される処置手順のタイプに依存して変化し得る。
スプリングリターンボタン518が、ロックされた位置にあることで、シリンジのプランジャ550が、トリガー514を係合し、トリガー514を握ることで、シリンジのプランジャ550が押し下げられる。シリンジのリザーバが、滅菌生理食塩水または滅菌水などの流体で満たされると、トリガー514を握ることで、流体はシリンジ528から膨張管542の管腔に流入し、図28に示すように膨張可能バルーンを膨張させる。トリガー514は、リターンスプリングを含んでおり、トリガー514が握り位置から解放されると、トリガーは本来の位置に戻って、シリンジのプランジャ550を上方に引き、それによりシリンジのリザーバ内に真空を作り出して、膨張可能バルーン540から流体を引き込み、バルーンを収縮させる。プランジャ550およびトリガー514は、当業者の精通する多様な構造を介して相互結合され得る。例えば、ラック(rack)およびピニオンギアを介して相互結合され得る。
本発明の別の局面は、スリングを身体組織内の開口またはポケットへ挿入するためのスリング適用デバイスである。スリング適用デバイスは、尿道と膣壁上部との間で組織へのアクセスを提供し、その組織内のポケットまたは開口へスリングを導入する。いくつかの実施形態では、スリング適用デバイスはスリングが挿入されるポケットまたは開口を作製する。他の実施形態では、スリング適用デバイスは予め形成されたポケットまたは開口へスリングを導入する。デバイスは、経皮方法のみで、または腹腔鏡検査処置手順で使用され得る。
187インチから約0.275インチであり得る。しかし当業者は、上述の寸法が解剖学的な考慮および実施される処置手順の種類によって変わり得ることを理解する。
第1シャフト716は、多様な材料から製造され得、これはステンレス鋼およびアルミニウムを含む。好ましくは第1シャフト716は、ステンレス鋼から製造される。
鈍切開器は、図50に示されるような栓塞子1110であり得る。栓塞子は、シャフトの遠位端に位置する可撓性セクション1114とシャフト1112の近位端に位置するハンドル1116との間に挟持された伸長平坦シャフト1112を備える。栓塞子1110がスリング適用デバイスの第1および第2シャフト716および718に挿入される場合、可撓性セクション1114は、栓塞子1110がシャフト716および718の遠位端近くの曲線に合致することが可能となるように曲がる。可撓性セクション1114は、栓塞子1110が第1および第2シャフト716および718に挿入される場合に第1および第2シャフト716および718の遠位端から伸長する通常剛性な先端1118をその遠位端で有する。通常剛性な先端1118は、第1および第2シャフト716および718が組織を通って前進する場合に接触する組織または骨を摩損することを防止する。別の実施熊様において、可撓性セクションは、可撓性を増加するために遠位端近くに開口を有し得る。
本発明の別の局面は、上で述べたガイド部材配置デバイスに類似する脱着可能部材スリング適用デバイスに関する。通常、脱着可能部材スリング適用デバイスは、シャフトを通って延びる、ハウジングに連結された管腔を有する導入シャフトを備えたハウジングを含む。脱着可能部材は導入シャフトの遠位端に配置され、脱着可能部材はスリングに取り付けられた少なくとも1つの縫合糸に連結される。脱着可能部材スリング適用デバイスのシャフト内の管腔は、その内部にスリングを受け取ることができる。好適には、スリングは、管腔内部にある場合に、アコーディオン状の形状である。アコーディオン状の構成は不規則なひだから構成され得る。
同様に、回収装置のシャフト2014は、図66に示す脱着可能部材スリング適用デバイス1410のシャフト1414と同じ構成を有し得る。好適には、係合部材2016は、シャフト2014の外表面上に環状リングを備える。
図73に示すように、ニードル1422は、脱着可能部材の係合表面1426が回収 装置2010の係合部材2016にアクセス可能であるように、ポケットまたは開口11内にトグルされる。好適には、ニードルは約30度〜約150度でトグルされる。より好適には、ニードルは約60度〜約120度でトグルされる。非常に好適な実施態様においては、ニードルは約90度でトグルされる。
本発明のさらなる局面は、尿道と上部膣壁との間の組織内に開口またはポケットを形成する裂孔技術、および裂孔技術において用いられるデバイスに関する。
膨張バスケット1716は、組織を約0.25インチ〜約1.5インチ膨張させ得る。好ましくは、膨張バスケット1716は、組織を約0.5インチから焼く1.25インチ膨張させる。特に好適な実施形態においては、膨張バスケット1716は組織を約1インチ膨張させる。
スリングにかかる張力は、上記のように調節され得る。骨固定子(bone anchors)または他の手段を用いて、上記のように縫合糸を固定して膀胱頚部を支持または尿道床を安定化することにより、尿自制力を維持または改善することができる。
特定の好適な実施形態について本発明を記載したが、本明細書中の開示内容を考慮すれば当業者には明白となる他の実施形態も本発明の範囲内である。従って、本発明の範囲は、添付の請求項を参照することによってのみ規定されることが意図されている。
尿失禁の処置のための経皮および裂孔アプローチに関するデバイスおよび方法が、本明細書中に提供される。特に、ガイド部材配置デバイス(10,1910)、スリング適用カテーテル(210,310,410)、組織切開器具/拡張器(510,610)、スリング適用デバイス、およびスリング適用システム、組織膨張器(1710)、把持デバイス(1810)、およびバルーンカテーテル(536,1536,1636)が本明細書中で開示される。尿自制を維持および改善するために、膀胱頸または尿道床を安定させる前述のデバイスを使用する方法もまた開示される。
12 ハンドル
13 中空管状本体
20 支持体
22 シャフト
60、61 恥骨上切開
64 尿道
Claims (1)
- ガイド部材を身体組織に挿入するためのガイド部材配置部材であって、以下、
近位端、遠位端および通じて延びる管腔を有するシャフトであって、該管腔はガイド部材を受けるよう適合されているシャフトと、
係合部材であって別のガイド部材配置デバイスと係合するためのシャフトの遠位端である係合部材、を含むガイド部材配置デバイス。
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JP2007139734A Expired - Lifetime JP4465369B2 (ja) | 1997-02-13 | 2007-05-25 | 経皮的および裂孔的なデバイスならびに最小侵襲性骨盤外科手術における使用のための方法 |
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2009
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2011
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Cited By (3)
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WO2013176100A1 (ja) * | 2012-05-23 | 2013-11-28 | テルモ株式会社 | 組織剥離装置 |
US9668769B2 (en) | 2012-05-23 | 2017-06-06 | Terumo Kabushiki Kaisha | Tissue separation device |
WO2014162424A1 (ja) * | 2013-04-01 | 2014-10-09 | テルモ株式会社 | チューブ組立体 |
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