JP4869648B2 - 誤発射防止用の単一ロックアウト機構を備えた外科用ステープラ - Google Patents
誤発射防止用の単一ロックアウト機構を備えた外科用ステープラ Download PDFInfo
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Description
本願は、言及することを以ってその開示内容の全てを本明細書の一部とする、2003年5月20日出願のフレデリック E.シェルトン4世(Frederick E. Shelton IV)、マイケル・アール・セッツァー(Michael Earl Setser)、ウイィアム・ブルース・ウェインバーグII世(Willium Bruce Weisenburgh II)による米国特許出願第10/441,424号(名称「発射防止用の単一ロックアウト機構を備えた外科用ステープラ(SURGICAL STAPLING INSTRUMENT HAVING A SINGLE LOCKOUT MECHANISM FOR PREVENTION OF FIRING)」)の一部継続出願である。
図2‐図4を参照すると、発射バー14が、発射中にエンドエフェクタ12の間隔を制御する垂直方向に離間した3つのピンを含む。具体的には、上部ピン38が、アンビル18とスープル溝16のピボット近傍のアンビルポケット40内に入るように配置されている。アンビル18が閉じた状態で発射されると、上部ピン38が、アンビル18に形成された先端方向に延びた長手方向のアンビルスロット42内を先端側に移動する。アンビル18における僅かな上方への反りは、上部ピン38による下方への力によって解消される。
Eビーム発射バー14によって提供される正確な垂直空間は、内視鏡装置の制限された空間に適している。更に、Eビーム発射バー14により、図5に示されている位置と同様のその先端部に垂直方向の反りを付与するキャンバーとアンビル16との組立が可能となる。このキャンバーアンビル16は、厚みの薄いアンビル16であってもエンドエフェクタ12に所望のギャップを付与するのに役立つという利点があり、大きさが制限される内視鏡装置に適している。
図6‐図9を参照すると、ガラス充填ポリカーボネートなどのポリマー材料から成形された第1のベース部分50及び第2のベース部分52から構成されるハンドル部分20が示されている。第1のベース部分50は、複数の円筒状のピン54を備えている。第2のベース部分52は、それぞれが六角形の開口58を備えた複数の延出部材56を含む。円筒状のピン54は、六角形の開口58内に受容されて摩擦により保持され、これにより、第1のベース部分50と第2のベース部分52の組立てが維持される。
図10‐図16に、外科用ステープラ/切断器具10のエンドエフェクタ12が詳細に示されている。上記したように、ハンドル部分20により、エンドエフェクタ12の閉止動作と発射動作を別々に行うことができる。このエンドエフェクタ12の別々の閉止及び発射(すなわち、ステープル止め及び切断)が、臨床的な柔軟性を保っているという利点がある。加えて、エンドエフェクタ12は、医師が組織を配置してクランプした後に、発射中の閉止間隔を維持するという前記した能力も提供する。これらの特徴により、この特徴がなければ不十分な量の組織がクランプされる場合に十分な間隔を提供したり、この特徴がなければ過剰な量の組織がクランプされる場合にクランプする力を強くして、外科用ステープラ/切断器具10の能力を手順的及び構造的に高めることができる。
使用する場合、外科用ステープラ/切断器具10は、図1、図2、及び図17‐図23に示されているように用いられる。図1‐図2において、器具10は開始位置にあり、スープル溝16の先端部にスナップ嵌めされた発射されていないステープルが完全に装着されているステープルカートリッジ37を有する。トリガ26及び28は前方の位置にあって、エンドエフェクタ12は開いている。これは体内の内腔内のトロカールまたは他の開口を介して挿入された後の典型的なエンドエフェクタ12である。次いで、図17に示されているように、医師が器具10を操作して、ステープル止め及び切断する組織248をステープルカートリッジ37とアンビル18との間に配置する。
上記したように、Eビーム発射バー14は、エンドエフェクタ12の間隔を確実に維持すると同時に、組織を切断しその切断部の両側にステープルを形成するユニークな機能を有する。図24を参照すると、発射バー14が先端側へ移動しないようにして、誤った組織の切断を防止することができる。図示されている単一ロックアウト機構270は、ステープルカートリッジ37が存在しないこと(ミッシング)または図24に示されている使用済みステープルカートリッジ37に応答して、発射バーの中間ピン46をブロックする(発射バーの中間ピンのみが図24に示されている)。
電気活性ポリマー(EAPs)は、電圧が加えられると形状が変化する導電物質がドープされた一連のポリマーである。要するに、この導電ポリマーを、一定の形態のイオン流体またはゲル及び電極と組み合わせることができる。この流体/ゲルのイオンが電圧が加えられると導電ポリマーに対して移動し、このイオンの流れによりポリマーの形状が変化する。加える電圧は、使用するポリマー及びイオン流体によって1V〜4kVの範囲である。電圧が加えられると、ある種のEAPsは収縮し、別のEAPsは膨張する。EAPsをばねや可撓性プレートなどの機械手段に組み合わせて、電圧を加えてこれらを変形させることができる。
図35に、Eビーム512がステープル止め組立体514内に完全に引き戻されている、開いた外科用ステープラ/切断器具510が示されている。組み立ての際、Eビーム512の下部脚516が、ステープル止め組立体514のステープル溝520の幅広開口518内を落下する。次いで、Eビーム512が、ステープル溝520に形成された下側トラック522に沿って先端側にスライドして前進する。具体的には、下側トラック522は、ステープル溝520の下面の上の幅広スロット526として開口している幅狭スロット524を含み、幅広開口518に連通した逆T字型の横方向の断面を形成している。組み立てられると、Eビーム512に取り付けられた発射バー528の基端側に結合された構成要素が、下部脚516が基端側に移動して幅広開口518に戻るのを防止するため、下部脚516が外れない。
図39及び図40に示されている外科用ステープラ/切断器具610は、図35‐図38に示されている外科用ステープラ/切断器具510に類似しているが、EAP作動ロックアウト機構650が基端側に延出した下方に作動するEAPプレートアクチュエータ592を利用する点が異なっている。このEAPプレートアクチュエータ592は、通常はステープル溝620に形成された傾斜凹部691をブロックするように整合しており、作動すると下方に曲がって傾斜凹部691に整合することができる(図40に692’として示されている)。従って、EAPプレートアクチュエータ692の基端部が、中間ピン530、従ってEビーム512からの発射の力を吸収する当接面693を提供する。
図41及び図42に示されている外科用ステープラ/切断器具710は、図35‐図38に示されている外科用ステープラ/切断器具510に類似しているが、EAP作動ロックアウト機構750が、基端側に延出した下方に作動するEAPプレートアクチュエータ592を利用する点が異なっている。このEAPプレートアクチュエータ792は、通常はステープル溝720に形成された傾斜凹部791を開口させるトラップドアとして整合しており、作動すると下方に曲がって傾斜凹部791を閉止して発射可能にすることができる(図40に792’として示されている)。従って、傾斜凹部の先端部の当接面793が、Eビーム512の中間ピン530からの発射の力を吸収して発射を防止する。
ハンドル部分の制御回路が、望ましいと判断した場合にEAPロックアウトが作動しないようにして、使用者の発射の指令またはその予想に有利に応答できることを理解されたい。例えば、ステープルカートリッジが存在しないこと、ステープルカートリッジが使用済みであること、またはエンドエフェクタに対してステープルカートリッジの大きさが不適切であることを検出すると、作動停止信号でEAPロックアウトが作動しないようにする、またはハンドル部分の制御回路が検出して判断することができる。別の例では、不適切にクランプされた組織を検出することができる(例えば、ジョーに沿って離間した複数の圧力トランスデューサがエンドエフェクタのある部分の過度の組織または過少の組織を検出できる)。加えて、薄い組織または厚い組織に対するバットレス部材を含むエンドエフェクタでは、バットレス部材の存在または非存在により、ロックアウトの作動停止を防止することができ、その逆も可能である。
(1)外科器具であって、
発射運動を起こすように機能的に構成されたハンドル部分と、
前記ハンドル部分に取り付けられた細長いシャフトと、
前記発射運動を伝達するために長手方向に往復運動する前記細長いシャフト内に受容された発射バーと、
前記細長いシャフトの先端側に取り付けられ、実施部分を成し、前記発射バーに応答して外科処置を行うエンドエフェクタと、
発射信号を生成するように機能的に構成された制御回路と、
前記発射信号に応答して、前記発射バーをブロックする位置からブロックしない位置またはその逆に状態を変える、前記実施部分に配置された電気ロックアウト機構とを含むことを特徴とする外科器具。
(2)前記電気ロックアウト機構が更に、電気活性ポリマーアクチュエータを含むことを特徴とする実施態様(1)に記載の外科器具。
(3)前記発射バーが、ブロックしている位置にある前記電気ロックアウト機構が引き込まれると乗り越えることができる傾斜した側面を含むことを特徴とする実施態様(2)に記載の外科器具。
(4)前記電気活性ポリマーアクチュエータが、前記発射バーの運動の軸に対して横断方向に作動するように配置されたスタックアクチュエータを含むことを特徴とする実施態様(2)に記載の外科器具。
(5)前記電気活性ポリマーアクチュエータが、上昇した位置及び降下した位置に作動及び弛緩するように機能的に構成された基端側を向いたロックアウトフィンガーを含むことを特徴とする実施態様(2)に記載の外科器具。
前記ロックアウトフィンガーが前記下降した位置にあると、前記発射バーが前記凹部の上を先端側に移動することができ、
前記ロックアウトフィンガーが前記上昇した位置にあると、前記ロックアウトフィンガーの基端部が前記発射バーに整合して当接することを特徴とする実施態様(5)に記載の外科器具。
(7)更に、前記発射バーに取り付けられた横断接触面を含み、
前記エンドエフェクタが、発射行程の初めの過程で前記横断接触面を受容するように整合した凹部を含み、
前記細長いシャフトが更に、前記横断接触面を前記エンドフェクタの凹部内に付勢する前記発射バーに対する付勢力を有し、
前記ロックアウトフィンガーが、前記接触面に対して前記凹部を閉止し、前記接触面を前記凹部内に案内するように配置されていることを特徴とする実施態様(5)に記載の外科器具。
(8)更に、前記電気活性ポリマーアクチュエータに積層された硬質基材を含むことを特徴とする実施態様(7)に記載の外科器具。
(9)外科器具であって、
発射運動を起こすように機能的に構成されたハンドル部分と、
前記ハンドル部分に結合されたステープル溝と、
前記ステープル溝に回動可能に取り付けられたアンビルと、
前記ステープル溝に係合し、複数のステープルドライバを含み、これらのステープルドライバを前記アンビルに対してカム動作させるステープル装置と、
前記ステープルドライバに長手方向に整合した、その基端側のウェッジ部材と、
前記発射運動に応答して前記ウェッジ部材を先端側に移動させる発射装置と、
前記ステープル溝に配置され、電気信号に応答して作動し、前記発射装置の先端側への運動を防止するように機能的に構成されたロックアウト装置とを含むことを特徴とする外科器具。
(10)前記ステープル装置が発射駆動スロットを含み、このスロット介して前記発射装置の少なくとも一部が先端側に移動して前記ウェッジ部材を駆動させ、前記ロックアウト装置が、前記ステープル溝から前記発射駆動スロット内に選択的に進入することを特徴とする実施態様(9)に記載の外科器具。
(12)前記電気活性ポリマーアクチュエータが、電気信号に応答して内側に膨張するように機能的に構成されたスタックアクチュエータを含むことを特徴とする実施態様(10)に記載の外科器具。
(13)前記ステープル溝が、前記電気活性ポリマーアクチュエータの基端側の傾斜した凹部を含み、
前記電気活性ポリマーアクチュエータが更に、前記傾斜した凹部に向かって曲がって作動するように機能的に構成された基端側を向いたビームを含むことを特徴とする実施態様(10)に記載の外科器具。
(14)前記基端側を向いたビームが、作動した時に前記発射部材に対する当接面を提供するように配置されていることを特徴とする実施態様(13)に記載の外科器具。
(15)前記基端側を向いたビームが、作動した時に前記発射部材の一部を前記傾斜した凹部内に案内するように配置されており、前記傾斜した凹部が先端当接面を有することを特徴とする実施態様(13)に記載の外科器具。
前記ロックアウト装置が横方向にずれて前記中間ピンに選択的に当接することを特徴とする実施態様(9)に記載の外科器具。
(17)前記細長いシャフトが更に、閉止スリーブを含み、
前記閉止スリーブの基端側が、閉止運動を受け取るために前記ハンドル部分に取り付けられ、前記閉止スリーブの先端側が、前記アンビルを閉止するために前記アンビル上のピボット構造に取り付けられていることを特徴とする実施態様(9)に記載の外科器具。
(18)外科器具であって、
発射運動を起こすように機能的に構成されたハンドル部分と、
前記ハンドル部分に取り付けられた細長いシャフトと、
前記発射運動を伝達するために長手方向に往復運動する前記細長いシャフト内に受容された発射バーと、
前記細長いシャフトの先端側に取り付けられ、実施部分を成し、前記発射バーに応答して外科処置を行うエンドエフェクタと、
発射信号を生成するように機能的に構成された制御回路と、
前記発射バーをブロックするように配置された前記実施部分の発射バーロックアウト装置を電気的に作動させるための手段とを含むことを特徴とする外科器具。
12 エンドエフェクタ
14 Eビーム発射機構または発射バー
16 溝形部材
18 アンビル
20 ハンドル部分
22 実施部分
23 シャフト
24 ピストルグリップ
26 閉止トリガ
28 発射トリガ
30 解放ボタン
32 閉止スリーブ
34 フレーム
36 発射駆動部材
37 ステープルカートリッジ
38 上部ピン
40 アンビルポケット
42 アンビルスロット
44 発射バーキャップ
45 スロット
46 中間ピン
47 発射駆動スロット
48 切断縁
49 垂直スロット
50 第1のベース部分
52 第2のベース部分
54 円筒状ピン
56 延出部材
58 六角形開口58
60 回動ノブ
62 貫通孔
64 ボス
70 外周ノッチ
72 溝形部材固定部材
74 ハンドル部分
76 ギア部分
78 中間部分
86 ヨーク
89 凹部
102、112、124 ばね
104 第1のクランプフック
118 上部ラッチアーム
122 凹部
128 係合面
130 前面
136 マルチプライヤ
138 駆動部材
140 金属製駆動ロッド
141 第1のギアラック
142 第2のギアラック
144 ノッチ
146 歯
148 第2のノッチ
150 第1のピニオンギア
152 第2のピニオンギア
154 第1のギアラック
156 ギア部分
204 ステープラ開口
208、210 延長構造
212、214 凹部
216 カートリッジ本体
218 ウェッジスレッド
220 シングルドライバ、ダブルドライバ
222 ステープル
224 カートリッジトレイ
226 取付けキャビティ
227 アンカー部材
228 ウェッジ
230 アンビルカムスロット
232 アンビルピボット
234 タブ
236 アンビルカム構造
238 発射コネクタ
239 スロットガイド
246 傾斜部分
248 組織
250 発射バーストッパー
510 外科用ステープル止め/切断器具
512 Eビーム
514 ステープル止め組立体
516 下部脚
518 幅広開口
520 ステープル溝
522 下側トラック
524 幅狭スロット
528 発射バー
530 中間ピン
532 上部ピン
534 アンビルポケット
536 アンビル
538 閉止スリーブ組立体
540 馬蹄形開口
550 EAP作動ロックアウト機構
552 幅広アンビルトラック
554 幅狭アンビルスロット
560 係合面
564 ステープルドライバ
558 ステープルカートリッジ
572 高い部分
574 クリップばね
578 細長いシャフト
580 実施部分
591 傾斜凹部
592 EAP垂直方向伸長アクチュエータ
610 外科用ステープル止め/切断器具
691 傾斜凹部
Claims (7)
- 外科器具であって、
発射運動を起こすように機能的に構成されたハンドル部分と、
前記ハンドル部分に取り付けられた細長いシャフトと、
前記発射運動を伝達するために長手方向に往復運動する前記細長いシャフト内に受容された発射バーと、
前記細長いシャフトの先端側に取り付けられ、実施部分を構成し、ステープルカートリッジを受容するように構成され、カートリッジと共に前記発射バーの長手方向運動に応答して組織切開と同時に切開箇所にステープル列を適用して外科処置を行うエンドエフェクタと、
ロックアウト作動停止信号を生成するように機能的に構成された制御回路と、
前記作動停止信号に応答して、前記発射バーに関してブロックする位置とブロックしない位置との間で状態を変える、電気作動式のロックアウト機構と、
を含み、
ロックアウト機構は、前記実施部分に設けられており、
ステープルカートリッジが存在しない場合、使用済みである場合、又は、大きさが不適切である場合を検出し、各場合にロックアウト作動停止信号がロックアウト機構に届かないようにする手段を更に含むことを特徴とする外科器具。 - 電気ロックアウト機構が更に、電気活性ポリマーアクチュエータを含むことを特徴とする請求項1に記載の外科器具。
- 電気活性ポリマーアクチュエータは、発射バーの運動の軸に対して横断方向に作動するように配置されたスタックアクチュエータを含むことを特徴とする請求項2に記載の外科器具。
- 電気活性ポリマーアクチュエータは、上昇位置及び下降位置の間において作動及び弛緩するように機能的に構成された基端側を向いたロックアウトフィンガーを含むことを特徴とする請求項2に記載の外科器具。
- 前記実施部分は、前記基端側を向いたロックアウトフィンガーを受容するように配置された内側を向いた凹部を含み、
ロックアウトフィンガーが下降位置にあると、発射バーが前記凹部の上を先端側に移動することができ、
ロックアウトフィンガーが上昇位置にあると、ロックアウトフィンガーの基端部が発射バーに整合して当接することを特徴とする請求項4に記載の外科器具。 - 発射バーに取り付けられた横断接触面を更に含み、
エンドエフェクタは、発射行程の初めの過程で前記横断接触面を受容するように整合した凹部を含み、
前記細長いシャフトは更に、前記接触面をエンドフェクタの凹部内に付勢する発射バーに対する付勢力を有し、
ロックアウトフィンガーは、前記接触面に対して前記凹部を接近させ、前記接触面を前記凹部内に案内するように配置されていることを特徴とする請求項4に記載の外科器具。 - 電気活性ポリマーアクチュエータに積層された硬質基材を更に含むことを特徴とする請求項6に記載の外科器具。
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US59169404P | 2004-07-28 | 2004-07-28 | |
US60/591,694 | 2004-07-28 | ||
US11/066,371 US7140528B2 (en) | 2003-05-20 | 2005-02-25 | Surgical stapling instrument having an electroactive polymer actuated single lockout mechanism for prevention of firing |
US11/066,371 | 2005-02-25 |
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2005
- 2005-02-25 US US11/066,371 patent/US7140528B2/en not_active Expired - Lifetime
- 2005-07-19 AU AU2005203134A patent/AU2005203134B2/en not_active Ceased
- 2005-07-27 CA CA2513945A patent/CA2513945C/en not_active Expired - Fee Related
- 2005-07-27 DE DE602005021279T patent/DE602005021279D1/de active Active
- 2005-07-27 EP EP05254693A patent/EP1621142B1/en active Active
- 2005-07-27 RU RU2005123968/14A patent/RU2005123968A/ru not_active Application Discontinuation
- 2005-07-27 AT AT05254693T patent/ATE468073T1/de not_active IP Right Cessation
- 2005-07-27 BR BRPI0503063-3A patent/BRPI0503063A/pt not_active IP Right Cessation
- 2005-07-27 JP JP2005216986A patent/JP4869648B2/ja active Active
- 2005-07-28 CN CNB2005100873403A patent/CN100566668C/zh active Active
- 2005-07-28 MX MXPA05008038A patent/MXPA05008038A/es active IP Right Grant
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CA2513945C (en) | 2013-09-24 |
AU2005203134A1 (en) | 2006-02-16 |
AU2005203134B2 (en) | 2012-02-16 |
CN1736340A (zh) | 2006-02-22 |
KR20060092850A (ko) | 2006-08-23 |
EP1621142B1 (en) | 2010-05-19 |
EP1621142A2 (en) | 2006-02-01 |
CN100566668C (zh) | 2009-12-09 |
RU2005123968A (ru) | 2007-02-10 |
JP2006034977A (ja) | 2006-02-09 |
CA2513945A1 (en) | 2006-01-28 |
BRPI0503063A (pt) | 2006-03-14 |
EP1621142A3 (en) | 2008-04-23 |
MXPA05008038A (es) | 2006-02-10 |
US7140528B2 (en) | 2006-11-28 |
DE602005021279D1 (de) | 2010-07-01 |
ATE468073T1 (de) | 2010-06-15 |
US20050173490A1 (en) | 2005-08-11 |
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