JP6495274B2 - 圧電封着ヘッドを備えた超音波吻合器具 - Google Patents
圧電封着ヘッドを備えた超音波吻合器具 Download PDFInfo
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Description
図1〜2は、ハンドルアセンブリ(20)、超音波ヘッドアセンブリ(40)、シャフトアセンブリ(18)、及びアンビル(60)を有する例示的な吻合用器具(10)を示し、それぞれについて、以下により詳細に説明する。シャフトアセンブリ(18)はハンドルアセンブリ(20)から遠位に延在する。超音波ヘッドアセンブリ(40)は、シャフトアセンブリ(18)の遠位端にある。アンビル(60)は、シャフトアセンブリ(18)のトロカール(34)と着脱可能に連結され、これにより、超音波ヘッドアセンブリ(40)に組織を圧縮するよう構成される。次に、ハンドルアセンブリ(20)は、超音波ヘッドアセンブリ(40)のトランスデューサ要素(70)を作動させ、超音波ヘッドアセンブリ(40)とアンビル(60)の間に捕捉された組織を切除及び封着するよう操作可能である。したがって、吻合用器具(10)は、図6A〜6Fに示すように、吻合(140)部位で、2つの管状組織構造(100、110)の自由端を合わせて、封着状態で接合するのに使用することができる。器具(10)の例示的な特徴が以下でより詳細に説明されるが、数多くの変形例が、本明細書の教示を鑑みれば当業者には明らかとなろう。
本実施例のハンドルアセンブリ(20)は、ピストルグリップ(22)と、トリガアセンブリ(24)と、ノブ(26)と、トロカール作動ボタン(30)と、を含む。ピストルグリップ(22)は単に任意追加的であり、これによりハンドルアセンブリ(20)は他の好適な種類のグリップ機能を提供し得る。ケーブル(16)はピストルグリップ(22)から延出し、更に発電機(12)に連結される。発電機(12)は、超音波ヘッドアセンブリ(40)のトランスデューサ要素(70)に電力を選択的に供給するよう操作可能である。あくまで一例として、発電機(12)は、Ethicon Endo−Surgery,Inc.(オハイオ州Cincinnati)により販売されているGEN 300を備えることができる。追加的にあるいは代替的に、発電機(12)は、2011年4月14日に公開された「Surgical Generator for Ultrasonic and Electrosurgical Devices」と題する米国特許公開第2011/0087212号(この開示は参照により本明細書に援用される)に示される教示の少なくとも一部に従って、構築され得る。また、発電機(12)の機能性の少なくとも一部をハンドルアセンブリ(20)に組み込むことができ、ハンドルアセンブリ(20)はケーブル(14)を省略するように更に電池又は他の搭載された電源を含むこともまたできると理解されたい。なお、発電機(12)が有することができる他の好適な形体、並びに発電機(12)が提供することができる種々の機構及び動作性は、本明細書の教示を考慮すれば、当業者には明らかとなるであろう。
本実施例において、シャフトアセンブリ(18)は剛性の湾曲した形状を有し、これは、直腸アプローチによる患者の大腸内での超音波ヘッドアセンブリ(40)の位置決めを促進し得る。いくつかの他の変形例において、シャフトアセンブリ(18)は剛性で真っ直ぐである。更に他の変形例において、シャフトアセンブリ(18)は可撓性である。更に別の単なる例示的代替例として、シャフトアセンブリ(18)は、可撓性構成と剛性構成の間を選択的に移行するよう操作可能であり得る。単なる一例として、そのような選択的移行は、2012年12月17日に出願された「Motor Driven Rotary Input Circular Stapler with Lockable Flexible Shaft」と題する米国特許出願第13/716,323号(この開示は参照により本明細書に援用される)の教示の少なくとも一部に従って提供することができる。
本実施例の超音波ヘッドアセンブリ(40)は、トランスデューサ要素(70)を受容するような寸法にされたソケットを画定するシュラウド(42)を含む。あくまで一例として、シュラウド(42)は、アルミニウム及び/又は任意の他の好適な材料を含み得る。トランスデューサ要素(70)は圧電材料で形成され、これによってトランスデューサ要素(70)は、発電機(12)からの電力を超音波振動に変換するよう構成される。図4〜5で最もよくわかるように、本実施例のトランスデューサ要素(70)は、穴(71)を画定する単一のモノリシックな圧電材料片からなり、これによって、トランスデューサ要素(70)は中空の細長い円筒状形状を有する。よって、トランスデューサ要素(70)は、遠位面(72)、近位面(74)、内径表面(76)、及び外径表面(78)を含む。あくまで1つの代替例として、トランスデューサ要素(70)は、同軸的に配列されて積層体とされる複数の圧電ディスク要素によって形成されていてもよい。トランスデューサ要素(70)が取り得る他の好適な形態は、本明細書の教示を考慮することで当業者には明らかとなるであろう。
図3で最も良くわかるように、本実施例のアンビル(60)は、ヘッド(62)と、柄(66)とを含む。ヘッド(62)は、近位側を向いた環状クランプパッド(64)を含む。いくつかの変形例において、クランプパッド(64)はポリテトラフルオロエチレン(PTFE)を含む。例えば、クランプパッド(64)は、PTFE又はその他の低摩擦材料でコーティングされた鋼を含み得る。別の単なる具体例として、クランプパッド(64)はポリイミド、グラファイト、及びPTFEの組み合わせを含み得る。クランプパッド(64)を形成するために使用され得る他の好適な材料(及びその組み合わせ)は、本明細書の教示を考慮することで、当業者には明らかであろう。クランプパッド(64)は、実質的に平坦であってよく、又は様々な種類の表面形状を含み得ることが理解されよう。例えば、クランプパッド(64)は、刻み、径方向に延在する***部の角度をつけて間隔を空けた配列(例えば、放射線模様など)、同心性環状***部の配列、十字交差する***部、及び/又はその他の様々な表面形状を含み得る。クランプパッド(64)はまた、先細であってもよい。例えば、クランプパッド(64)の露出表面は、クランプパッド(64)の内径部分の厚さが、クランプパッド(64)の外径部分の厚さよりも厚くなるように、先細であり得る。別の単なる具体例として、クランプパッド(64)は、クランプパッド(64)が、角の丸い正三角形の断面形状を有するように、先細であり得、アンビル(60)がトロカール(34)と連結したときに、トランスデューサ要素(70)の遠位面(72)に先端が向くようになっていてよい。
図6A〜6Fは、器具(10)がある管状組織構造(100)を別の管状組織構造(110)と接合するのに使用されるプロセスを示す。あくまで一例として、組織構造(100、110)は、患者の腸管(例えば、結腸など)の一部を含み得、この管は切断されて管の一部が除去され、自由端(104、114)が残されている。図6Aに示すように、超音波ヘッドアセンブリ(40)は、トロカール(34)が管状組織構造(110)の開放自由端(114)から突出するように、下の管状組織構造(110)を通って挿入されている。アンビル(60)は、柄(66)が管状組織構造(100)の開放自由端(104)から突出するように、上の管状組織構造(100)を通って挿入されている。超音波ヘッドアセンブリ(40)及びアンビル(60)が図6Aに示す位置に配置され得る様々な好適な方法が、本明細書の教示を考慮することで、当業者には明らかであろう。
本明細書で説明した教示、表現、実施形態、実施例などの任意の1つ以上を、本明細書で説明される他の教示、表現、実施形態、実施例などの任意の1つ以上と組み合わせることができることが理解されるべきである。したがって、上述の教示、表現、実施形態、実施例などは、互いに関して孤立して考慮されるべきでない。本明細書による教示を組み合わせることができる様々な好適な方法は、本明細書の教示を考慮することで、当業者には容易に明らかであろう。そのような修正及び変形は、特許請求の範囲内に含まれるものとする。
(1) (a)本体と、
(b)該本体から遠位側に延在するシャフトであって、該シャフトが遠位端を有する、シャフトと、
(c)該シャフトの該遠位端に配置される超音波要素であって、該超音波要素が遠位方向に向く環状面を含む、超音波要素と、
(d)環状クランプパッドであって、該クランプパッドが該超音波要素の該遠位方向に向く環状面に向かって移動可能である、環状クランプパッドと、
を含む、機器。
(2) 前記本体がハンドルアセンブリを含む、実施態様1に記載の機器。
(3) 前記シャフトが湾曲している、実施態様1に記載の機器。
(4) 前記超音波要素が超音波トランスデューサを含む、実施態様1に記載の機器。
(5) 前記超音波トランスデューサが円筒状形状を有する、実施態様4に記載の機器。
(7) 前記超音波要素が中央穴を画定する、実施態様1に記載の機器。
(8) 前記超音波要素の前記中央穴を通って延在する細長い部材を更に含み、該細長い部材は、該超音波要素の該遠位方向に向く環状面に近づく方向及び該遠位方向に向く環状面から離れる方向に前記クランプパッドを選択的に動かすよう操作可能である、実施態様7に記載の機器。
(9) 前記細長い部材がトロカールを含む、実施態様8に記載の機器。
(10) アンビルを更に含み、該アンビルが、
(i)前記クランプパッドが固定される、ヘッドと、
(ii)該ヘッドから延出し、前記細長い部材と連結されるよう構成されている、柄と、
を含む、実施態様8に記載の機器。
(12) 前記シャフトの前記遠位端がシュラウドを含み、前記超音波要素が該シュラウド内に配置されている、実施態様1に記載の機器。
(13) 前記シュラウドが、前記超音波要素の外側領域に対して内向きの圧縮力を印加するよう構成されている、実施態様12に記載の機器。
(14) 前記シュラウドが遠位縁を含み、前記遠位方向に向く環状面が該遠位縁と同一面である、実施態様12に記載の機器。
(15) 前記超音波要素が、長手方向の動き及び径方向の動きで超音波振動するよう構成されている、実施態様1に記載の機器。
(17) 前記超音波要素に電力を供給するよう操作可能な発電機を更に含み、該発電機がケーブルを介して前記本体に連結されている、実施態様1に記載の機器。
(18) (a)本体と、
(b)該本体から遠位側に延在するシャフトであって、該シャフトが遠位端を有する、シャフトと、
(c)該シャフトの該遠位端に配置される円筒状超音波トランスデューサであって、該超音波トランスデューサが遠位方向に向く環状面を含む、円筒状超音波トランスデューサと、
(d)該超音波トランスデューサに対して並進運動可能なアンビル連結機構と、
(e)アンビルであって、該アンビルが該アンビル連結機構と連結するよう構成されており、該アンビルが環状クランプパッドを含み、該クランプパッドが、該超音波トランスデューサの該遠位方向に向く環状面に向かって移動可能である、アンビルと、
を含む、機器。
(19) 第1中空組織構造と第2中空組織構造との間の吻合を形成する方法であって、
(a)第1中空組織構造に超音波要素を挿入することであって、該超音波要素が遠位方向に向く環状面を含む、ことと、
(b)第2中空組織構造に環状クランプパッドを挿入することと、
(c)該遠位方向に向く環状面と該クランプパッドとの間にある、該第1中空組織構造の組織と、該第2中空組織構造の組織とを、圧縮することと、
(d)該超音波要素を超音波エネルギーで作動させ、これにより、該遠位方向に向く環状面と該クランプパッドとの間に捕捉された組織を切断及び封着することと、
を含む、方法。
(20) 前記第1及び第2中空組織構造が、消化管の一部分を含む、実施態様19に記載の方法。
Claims (14)
- (a)本体と、
(b)前記本体から遠位側に延在するシャフトであって、前記シャフトが遠位端を有する、シャフトと、
(c)前記シャフトの前記遠位端に配置される超音波要素であって、前記超音波要素が遠位方向に向く環状面を含む、超音波要素と、
(d)環状のクランプパッドであって、前記クランプパッドが前記超音波要素の前記遠位方向に向く環状面に向かって移動可能である、環状のクランプパッドと、
を含み、
前記超音波要素が超音波トランスデューサであり、
前記超音波トランスデューサが円筒状形状を有し、
アンビルを更に含み、前記アンビルが、前記クランプパッドが固定されるヘッドを含み、
前記ヘッドが、前記クランプパッドに対して内側にある陥凹部を画定し、
前記シャフトの前記遠位端がシュラウドを含み、前記超音波トランスデューサが前記シュラウド内に配置されており、
1の管状組織構造が前記アンビルに固定され、他の管状組織構造が前記シュラウドに固定されている際に、前記クランプパッドが前記超音波トランスデューサの前記遠位方向に向く環状面に向かって移動して、前記1の管状組織構造の自由端および前記他の管状組織構造の自由端が前記陥凹部内に集められ、前記1の管状組織構造および前記他の管状組織構造が前記クランプパッドおよび前記超音波トランスデューサの前記遠位方向に向く環状面間で挟み込まれた状態で、前記超音波トランスデューサにより生成された超音波振動により、前記1の管状組織構造および前記他の管状組織構造を切断および封着する、機器。 - 前記本体がハンドルアセンブリを含む、請求項1に記載の機器。
- 前記シャフトが湾曲している、請求項1に記載の機器。
- 前記本体から前記超音波トランスデューサまで前記シャフトを通って延在する、1つ又は2つ以上の電気導体を更に含む、請求項1に記載の機器。
- 前記超音波トランスデューサが中央穴を画定する、請求項1に記載の機器。
- 前記超音波トランスデューサの前記中央穴を通って延在する細長い部材を更に含み、前記細長い部材は、前記超音波トランスデューサの前記遠位方向に向く環状面に近づく方向及び前記遠位方向に向く環状面から離れる方向に前記クランプパッドを選択的に動かすよう操作可能である、請求項5に記載の機器。
- 前記細長い部材がトロカールを含む、請求項6に記載の機器。
- 前記アンビルが、前記ヘッドから延出し、前記細長い部材と連結されるよう構成されている柄を含む、請求項6に記載の機器。
- 前記シュラウドが、前記超音波トランスデューサの外側領域に対して内向きの圧縮力を印加するよう構成されている、請求項1に記載の機器。
- 前記シュラウドが遠位縁を含み、前記遠位方向に向く環状面が前記遠位縁と同一面である、請求項1に記載の機器。
- 前記超音波トランスデューサが、長手方向の動き及び径方向の動きで超音波振動するよう構成されている、請求項1に記載の機器。
- 前記クランプパッドが、止血又は組織治癒を強化するように構成された物質を含む、請求項1に記載の機器。
- 前記超音波トランスデューサに電力を供給するよう操作可能な発電機を更に含み、前記発電機がケーブルを介して前記本体に連結されている、請求項1に記載の機器。
- (a)本体と、
(b)前記本体から遠位側に延在するシャフトであって、前記シャフトが遠位端を有する、シャフトと、
(c)前記シャフトの前記遠位端に配置される円筒状の超音波トランスデューサであって、前記超音波トランスデューサが遠位方向に向く環状面を含む、円筒状の超音波トランスデューサと、
(d)前記超音波トランスデューサに対して並進運動可能なアンビル連結機構と、
(e)アンビルであって、前記アンビルが前記アンビル連結機構と連結するよう構成されており、前記アンビルが、環状のクランプパッド、及び、前記クランプパッドが固定されるヘッドを含み、前記クランプパッドが、前記超音波トランスデューサの前記遠位方向に向く環状面に向かって移動可能であり、前記ヘッドが、前記クランプパッドに対して内側にある陥凹部を画定し、アンビルと、
を含み、
前記シャフトの前記遠位端がシュラウドを含み、前記超音波トランスデューサが前記シュラウド内に配置されており、
1の管状組織構造が前記アンビルに固定され、他の管状組織構造が前記シュラウドに固定されている際に、前記クランプパッドが前記超音波トランスデューサの前記遠位方向に向く環状面に向かって移動して、前記1の管状組織構造の自由端および前記他の管状組織構造の自由端が前記陥凹部内に集められ、前記1の管状組織構造および前記他の管状組織構造が前記クランプパッドおよび前記超音波トランスデューサの前記遠位方向に向く環状面間で挟み込まれた状態で、前記超音波トランスデューサにより生成された超音波振動により、前記1の管状組織構造および前記他の管状組織構造を切断および封着する、機器。
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EP3068490A1 (en) | 2016-09-21 |
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