JP3771282B2 - 結び形状を有する変形可能な生体被吸収性プラスチツクのステープル及びかかるステープルを変形させる方法及び装置 - Google Patents

結び形状を有する変形可能な生体被吸収性プラスチツクのステープル及びかかるステープルを変形させる方法及び装置 Download PDF

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JP3771282B2
JP3771282B2 JP18089893A JP18089893A JP3771282B2 JP 3771282 B2 JP3771282 B2 JP 3771282B2 JP 18089893 A JP18089893 A JP 18089893A JP 18089893 A JP18089893 A JP 18089893A JP 3771282 B2 JP3771282 B2 JP 3771282B2
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staple
anvil
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ジヨン・エイ・コナーズ
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/0682Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
    • A61B17/0686Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying below the tissue during stapling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064Surgical staples, i.e. penetrating the tissue
    • A61B17/0644Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • AHUMAN NECESSITIES
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    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L31/00Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • AHUMAN NECESSITIES
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
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    • A61B2017/07264Stapler heads characterised by its anvil characterised by its staple forming cavities, e.g. geometry or material
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    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S411/00Expanded, threaded, driven, headed, tool-deformed, or locked-threaded fastener
    • Y10S411/904Fastener or fastener element composed of nonmetallic material
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S411/00Expanded, threaded, driven, headed, tool-deformed, or locked-threaded fastener
    • Y10S411/92Staple

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Description

【0001】
【発明の分野】
本発明は、外科用ステープル、及び組織の隣接層を一緒に固定するようにかかるステープルを変形させるために使用される方法及び装置、特に外科用ステープル器具用のアンビルに関する。より特別には、本発明は、身体器官及び組織を縫合する変形可能な生物被吸収性のプラスチック又はポリマーのステープルのための形状、及びステープルを縫合する形状に変形させる正確に形成されたアンビルにに関する。
【0002】
【従来技術の説明】
歴史的には、器官及び組織の外科的又はその他の創傷の縫合は手で行われた。通常の手による縫合技術は高度の外科的な熟練を必要とする。しかし、かかる技術の専門的技術は縫合ごとに変化し、このため手術処置の最終段階の実行における出来栄えが広く変動する。更に、極めて熟達した外科医でさえも、比較的小さな創傷でもこれを縫合するにはかなりの時間を必要とする。従って、縫合処置中に望ましくない量の血液を失うことがありうる。
【0003】
従って、近年は医学的処置の後で身体の器官及び組織を縫合するために外科用ステープルを使う傾向が増大しつつある。外科用ステープルは、肺、並びに食道、胃、十二指腸、及び腸管のその他の身体器官のような身体の器官及び組織の縫合に特に効果的である。
【0004】
外科用ステープルの出現は、公知の縫合技術に幾つかの注目すべき利点を提供した。第1に、簡単に作動できる特別に適合した装置を使用して、1列又は2列の外科用ステープルを組織内に挿入できるので、外科医が変わってもほぼ一様な閉鎖が得られる。更に閉鎖内の総てのステープルは、通常は同時に挿入され、又は全創傷にわたり迅速に次々と挿入される。従って、閉鎖が非常に速やかに行われ、血液の損失を最小にする。
【0005】
外科用ステープルは、胃腸吻合具及び横断縫合具を含んだ吻合具として知られた外科用ステープル装置により組織内に機械式に挿入されるのが普通である。かかる器具において、ステープルはマガジン又はカートリッジ内に細長い1列又は2列に装填される。次いで、マガジンは、ステープルをマガジンから組織の2以上の部分を貫いて変形用アンビルの方に押し出し又は推進する機構を有する器具に取り付けられる。推進作動の最後において、各ステープルの脚は、通常、アンビルとの組み合いにより閉じられた形状に掴まれ又は曲げられ、縫合を完成し組織部分を一緒に連結する。
【0006】
胃腸吻合式の器具は列に整列したステープルを迅速に次から次に推進し曲げる。横断吻合式の器具は列内の総てのステープルを同時に推進しかつ曲げる。
【0007】
胃腸吻合式外科用ステープル器具及び横断式外科用ステープル器具の両者に使用される図1に示された通常形式のステープル10は、身体内で実質的に不活性なステンレス鋼又はチタンのような金属で作られる。未変形ステープル10、又はステープルブランクは、一般にU字形であり、バックスパン12及びバックスパンから直角方向に伸びかつ互いに平行な2本の脚14を有する。各脚14は身体の器官又は組織にきれいに突き刺せるように鋭い鑿状の尖端部16を持つ。金属のステープルブランクは、脚が通常のアンビルと組み合ってこれに追従し、図2に示されるようなB字形に閉じられたステープル18を形成するように曲げられる。
【0008】
金属の外科用ステープルを曲げるために使用されるアンビルは硬質金属で形成され、かつステープル器具のマガジン内に置かれた各ステープルに対面して置かれた1対の刻印され又はポンチされたポケットを持ったステープル曲げ面を備える。このポケットは、マガジン内に保持された対応するステープルのバックスパンと平行に同一線上に配置された通常は細長い弧状の凹所である。従って、このアンビルは普通の紙用のステープラーのアンビルと類似している。
【0009】
ステープル10がマガジンからアンビルの方に駆動されると、ステープルの脚14の各は一方のポケットと組み合い、従って両方の脚は、最初は互いに近寄る向きに曲げられ、その後、バックスパン12に向かって上向きに曲げられる。従って、図2に示されるように、尖端部16はバックスパン12の下側に押し付けられた状態になることができる。
【0010】
上述の方法で挿入された金属ステープルは縫合の効果的かつ比較的簡単な手段であるが、一つの重要な欠点はこれらが患者の身体内に永久的に留まることである。これらは、一般に身体を傷つけることはないが、それにもかかわらず、これら自体が患者の術後のX線又はその他の診断像を妨害することがある。
【0011】
この欠点は、短期間後に身体内で分解しうる生体被吸収性ポリマーのステープルに使用により克服できる。しかし、通常のポリマーのステープルは塑性がなく、従って、縫合を完成するために図2に示されたB字形に曲げるのは容易ではない。このため、図3に示されたように、かかる通常の生体被吸収性ステープルは2個の部品、即ちU字形ポリマーステープル本体20、及びその脚に連結されたポリマーの棒状閉鎖材24により作られる。閉鎖材は尖端部受け入れ用の2個の穴26を有し、この穴は縫合される組織を刺した後のステープル本体20の尖端部の上に適合する。次いで、ステープル本体20及び閉鎖材24が互いに近寄るように押され縫合を完了する。
【0012】
この2部品式ステープルは身体内で分解し、その後、術後の処置を妨げないが、これは基本的なステープルブランクの他に1部品が必要であり、従ってこの2部品を適正に整列させかつこれらを一緒に駆動するために更に複雑な機械式ステープル器具を必要とする欠点がある。
【0013】
更に近年、生体被吸収性ステープルの分野における技術突破がなされた。特に、ポリマー材料を使用した生体被吸収性又は部分的に生体被吸収性の外科用ステープルが開発された。(以下、用語「生体被吸収性」は上述の応用の両方に説明された形式の外科用ステープルを総称的に説明するために使用されるであろう)。これらのステープルは、公知の生体被吸収性ステープルの有益な特性の総てを保持するが、更に金属ステープルのように変形可能な又は塑性変形しうることはない。即ち、これらのステープルは複雑な形状に曲がりかつその形状に留まることができる。従って、これらは1個の部片で作ることができ、別個のステープル本体と閉鎖用部材とを必要としない。
【0014】
それにもかかわらず、この新らしい生体被吸収性ステープルはステープル脚の鑿状尖端部がバックスパンに当たるように、図2に示されたような通常の金属ステープルと同じ方法で曲げられたときは、尖端が砕け又は破損することが有り得る。
【0015】
このため、上述の新しいポリマー材料の特性の利点の得られる外科用ステープル及びその挿入用器具の改良が望ましい。
【0016】
従って、外科用ステープル技術における変形可能な生体被吸収性のポリマーステープルの使用により得られる便益を強化することが本発明の主目的である。
【0017】
組織の障害及びステープル自体の損害が最小で組織部分を一緒に確実に連結する正確な形状に変形される変形可能な生体被吸収性のポリマーステープルを提供することが本発明の別の目的である。
【0018】
ステープル連結された組織をより良く固定するように結ばれた形状に変形される変形可能な生体被吸収性のポリマーステープルを提供することが本発明の更に別の目的である。
【0019】
ステープル連結された組織を固定するために可変の閉鎖力を有する変形可能な生体被吸収性のポリマーステープルを提供することが本発明のなお別の目的である。
【0020】
変形可能な生体被吸収性のポリマーステープル並びにその他のステープルを所望の形状に正確かつ均一に変形させるであろう外科ステープル装置用の高度に正確なアンビルを提供することが本発明のなお別の目的である。
【0021】
変形可能な生体被吸収性のポリマーステープルを所望の形状に変形させる方法を提供することが本発明のなお別の目的である。
【0022】
上述の形式の変形可能な生体被吸収性のポリマーステープルの有益な特性の利点を得る特殊なアンビルを提供し、一方では改良された外科ステープル器具を提供することが本発明の更に別の目的である。
【0023】
これらの目的及びその他の目的は、変形可能な生体被吸収性のポリマーステープルにより達成され、このステープルは好ましい実施例においては、バックスパン、及びバックスパンの両端から第1の方向に伸びてそれぞれ尖端部で終わる第1と第2の脚を備える。各脚は、曲がり部、及びバックスパンを通って第1の方向に伸びている垂直面を横切って伸びる湾曲部を有し、それぞれの脚の湾曲部は互いに交差する。
【0024】
別の態様においては、バックスパン及びバックスパンの両端から第1の方向に伸び変形前の状態においてはバックスパンに対して実質的に直角な第1及び第2の脚を有する変形可能な生体被吸収性のポリマーステープルを変形させる好ましい方法が明らかにされる。この第1及び第2の脚は尖端部において終わる。この方法は、各がバックスパン間の直線部分と曲がり部とを有する各脚に曲がり部を形成するように第1及び第2の脚を互いに近寄せるようにまず変形させ、次いで、各脚において、曲がり部から始まり第1のバックスパンを通って第1の方向に定められた垂直面を横切って伸びる円弧状になるように尖端部に伸びている湾曲部分に各脚を変形させる。各脚の湾曲部分は互いに交差する。
【0025】
更に別の態様によれば、本発明の好ましい実施例は、バックスパン及びバックスパンの両端から1方向でかつ未変形状態においてバックスパンに実質的に垂直に伸びている第1及び第2の脚を有する変形可能な外科用ステープルを変形させる外科用ステープル器具用のアンビルである。このアンビルは長手方向中心線を有する支持体を備え、更に水平面内のステープル受け面、第1及び第2のポッケト凹所を有し、このポッケト凹所の各はステープル受け面に置かれた入り口端から出発しステープル受け面の下方の本体内の凹んだ部分に連なり、ステープル受け面における出口端において終わる。第1及び第2のポッケト凹所の各は円弧状部分を有し、各の入り口端が実質的に長手方向中心線上に置かれ更に各の出口端が他方のポッケト凹所の出口端が置かれた側とは長手方向中心線の反対の側に置かれ更に円弧状部分が水平方向面に沿って湾曲しほぼ長手方向中心線において互いに交差するような状態で同一直線上にないように伸びる。アンビルの方に駆動されそしてそれぞれ第1及び第2のポッケト凹所の入り口端の中に受け入れられるステープルの第1及び第2の脚は、その出口端に案内されバックスパンに向かって変形させられ、第1及び第2の脚の末端が反対側の脚の曲がり部とバックスパンとの間を伸びるように成形される。
【0026】
もちろん、本発明により形付けられた外科用ステープル器具用のアンビルは、適宜の材料の外科用ステープルに使用し得ることが認められるであろう。しかし、これは非金属の変形可能な生体被吸収性のポリマーステープルに使用するように特に設計されるので、これは費用が少ないプラスチック材料で作ることができ、この場合は公知の固い金属アンビルよりも非常に正確なポッケト凹所を容易に作ることができる。
【0027】
【実施例】
本発明のこれら及びその他の目的、態様、特徴、及び利点は、図面に関連して得られる好ましい実施例についての以下の詳細な説明より明らかとなるであろう。
【0028】
上述のように、本発明による外科用ステープルはポリマー又はプラスチック材料より作られる。これらステープルはこの特殊な材料で作られるため、これらは塑性変形可能であり又は伸びることができ、なおかつ生体被吸収性である。本発明は、改良された変形特性、その形状にステープルを変形させる方法、及びその使用によりこの形状が得られる外科用ステープル器具のアンビルを提供する特殊な特性の利点がある。もちろん、後で開発されたその他の生体被吸収性又は部分的に生体被吸収性の変形可能なポリマーステープルを本発明に適合させることができる。
【0029】
代わりの変形可能な生体被吸収性のプラスチックステープルが図4及び5に示される。これらの図面は、始めは互いの方に曲がり次いでバックスパン12’の方に上向きに方向を変え、いわゆる食い違いB字形を形成する脚14’のあるプラスチックステープルを明らかにする。この形状は、脆い尖端部がバックスパンの下側に当たらないようにこれを保護する。本発明は代わりのプラスチックステープル形状及びその達成方法に向けられる。
【0030】
より特別には、本発明による外科用ステープル又はステープルブランク30は、図6に示されたその未変形状態においては、図1に示された通常の形状のと同様に一般にU字形である。従って、改良されたステープル30は、バックスパン32、2個の脚34、及び各脚34の端末に形成された尖端部36を持つ。尖端部は鋭く鑿状にされて、縫合すべき身体器官又は組織をきれいに切断する。
【0031】
図7及び8は、本発明によるプラスチックステープル30をその変形状態において示す。ステープルは縫合すべき組織50の2層を刺しているとして示される。各脚34は、曲がり部38を有しこの曲がり部とバックスパン32との間の真っすぐな第1の部分40及び曲がり部の端末側端部の湾曲した第2の部分42がある。
【0032】
以下説明されるアンビルによるステープルの変形の際は、第1の曲がり部38が各脚の中間位置に形成される。図7に示されるように、真っすぐな第1の部分は、バックスパンから実質的に直角に垂直方向、又はX軸方向に伸びる。実際上は、各脚は、好ましくは曲がり部が形成されるときに僅か内向きに曲げられて、水平y軸と角度θを形成し、この角度はx−y平面において90゜より僅かに大きい。曲がり部が形成された後に、湾曲した第2の部分はアンビル内で互いに近寄るように案内され次いで水平面、すなわち図7のy−z面内で円弧状に曲げられた経路に沿ってバックスパンの方に上向きに案内される。
【0033】
図8に最もよく見られるように、湾曲した第2の部分の各は垂直方向のx−y平面から約20゜の角度αで曲がり部から伸び、バックスパンの下でこれを回って戻り、バックスパン32と脚34の第1の部分とで定められる垂直方向のx−y平面を横切る。各脚は同じように曲げられるため、脚は湾曲した第2の部分を横切り結び44を形成し、尖端部はバックスパンの下側と組織の層及び反対側の脚の曲がり部の間の隙間を通って伸びる。脚34がこの方法で曲げられるとステープルはプレッツェルとほぼ似た形となり、この形状は「プレッツェル」又は「結び」デザインと呼ぶことができるものである。普通に変形されたステープルと比べてこのデザインの一つの重要な利点は、各脚の尖端部がバックスパンと反対側の脚の曲がり部との間の隙間内に挟まれ、脚の湾曲した形状によりステープルが隙間から滑り出るように緩むことを不可能ではないとしても困難とさせることである。従って、ステープルはその変形された状態に留まり組織の確かな縫合が維持される。
【0034】
プレッツェルデザインの別の利点は、図7を参照すれば、脚の尖端部が組織を下側から再び刺さないことである。そうではなくて、僅かの角度のアンビルの緩やかな上向きの傾斜が脚の第2の湾曲部分を変形させ、従って、脚はバックスパンを押す力で組織を実際に圧縮できる。更に、この圧縮力又は閉鎖力は、アンビル内のステープルに対するステープル器具の行程、従って真っすぐな直線部分の長さを変えることにより調整できる。
【0035】
本発明によるポリマーステープルの変形に使用されるアンビル52の一つの形式が図9ないし11に示される。アンビル52はステープル受け面56を有する支持構造54を持つ。この面と支持構造とは1体構造又は複数部品構造のいずれとすることもできる。
【0036】
面56はステープルの脚を受け、所望の形状に案内し又は方向付けるための2個の案内路58を備える。
【0037】
図9ないし11に示されるアンビルは1対の案内路しか備えていないが、通常の場合は、かかるポケットの対の細長い列を同様に細長い支持構造54に形成して、多数の外科用ステープルを同時に、又は迅速に次々と駆動することができる。
【0038】
案内路58はそれぞれ入り口端60から出口端62に湾曲する。案内路は図10に示されるように水平面y−zに関して湾曲し、上述のような脚の湾曲した第2の部分を曲げる。図11に示されるように、案内路58は尖端部を受け入れ各ステープル脚に曲がりを形成する凹んだポケット64を持つ。凹んだポケットは脚の幅よりも狭い幅を持った逃げ溝66を備える。この方法で、脚が凹んだポケットに入るとき、尖端部は逃げ溝内に入るがその底面には達しないであろう。これが鑿状にされた尖端部の破損を防ぐ。案内路58は凹んだポケットから上向きに傾斜して脚をバックスパンの方に案内し、これと同時に案内路の水平方向の湾曲が互いに交差し、反対側の案内路の入り口端より先に伸び、従って脚は上述のようなプレッツェル形に変形される。
【0039】
アンビルは、長手方向中心軸B−B(図10参照)が、アンビルの方に駆動されるステープルのバックスパンと実質的に平行であるように外科用ステープル器具内に配置される。更に、それぞれの経路58の入り口端60は、アンビルの方に駆動されるステープルの脚34のそれぞれの尖端部36を受け入れるように間隔をあけられる。従って、ステープルがそのように駆動されると、尖端部36の各がまず一つの案内路58の入り口端60と遭遇する。アンビルに向かうステープルの駆動が続くと、尖端部36は湾曲した案内路58に沿って向きを変えられ脚の結びを形成し、駆動が完了したときは、尖端部は最終的にはバックスパンの下側と反対側の脚との間に形成された隙間の中に駆動される。
【0040】
従って、本発明による外科用ステープル器具のアンビルは、これに向かって駆動される変形可能なステープルを特殊な所望の変形形状にさせるであろう。更に、このアンビルは、ポリマー材料製の変形可能な生体被吸収性のステープルに使用するように特別に設計されるので、金属のような硬化した材料で作ることはそれ自体不要である。このことは、非常に費用のかかる機械加工技術以外では上述のような正確な形状にされたアンビルポケットを硬化した金属に形成することが困難であるため、特に重要である。公知の金属アンビルに通常の形のアンビルポケットを形成する実際の型打ち又はポンチ技術は、本発明による正確な形状のアンビルポケットの形成には不適である。従って、製造工程において正確であるが費用の少ない射出成型方法を使用して新規なアンビルを作るためにプラスチックを使用することができる。更にまた、本発明のアンビルを作り得るプラスチックは通常のアンビルに使用される金属よりそれ自体で安価である。従って、本発明は従来技術に対して相当な利点を提供する。
【0041】
ポリカーボネート及び液晶ポリマー(LCP)のようなポリマー材料は本発明のアンビルについての使用に適していることが見いだされた。
【0042】
熟練技術者に容易に認められるであろうように、本発明は外科用ステープル及びステープル器具のアンビルに対して顕著な改善を与える。これは、公知の生体被吸収性のポリマーステープルと組み合った欠点なしにその便益の総てを達成する。更に、最近開発された変形可能な生体被吸収性ポリマーのステープルの特殊な特性の利点を得ることにより、本発明は特殊に変形されたステープル形状、並びに特殊な外科用ステープル器具のアンビル及びかかる形状を作る方法を提供する。
【0043】
本発明の特別な実施例が詳細に上述されたが、この説明は単に解説のためだけのものであることが理解されよう。熟練技術者は、以上の説明に加えて好ましい実施例の開示された態様の種々の変更及びこれら態様に相当する構造を、本発明の請求範囲に定められた本発明の精神から離れることなく行うことができる。本発明の範囲は、かかる変更及び相当の構造を包含するように最も広く解釈すべきである。
【0044】
本発明の実施態様は次の通りである。
【0045】
1.バックスパン;及び
前記バックスパンの両端から第1の方向に伸びて各が尖端部において終わる第1及び第2の脚
を備え、
各脚が曲がり部及び第1の方向に伸びかつ前記バックスパンを通る垂直面と交差して伸びている湾曲部分を有し、それぞれの脚の各の湾曲部分が互いに交差している
変形される変形可能な生体被吸収性ポリマーの外科用ステープル。
【0046】
2.前記尖端部の各が反対側の脚の前記曲がり部と前記バックスパンの下側との間を伸びる上記1による変形される変形可能な生体被吸収性ポリマーの外科用ステープル。
【0047】
3.前記脚の各が前記曲がり部と前記バックスパンとの間の真っすぐな部分を有し、前記真っすぐな部分は前記バックスパンから実質的に直角方向に伸びている上記2による変形される変形可能な生体被吸収性のポリマー外科用ステープル。
【0048】
4.前記湾曲部分が前記脚の末端において前記曲がり部から伸び、前記湾曲部分は円弧状の形にされかつ反対側の脚に向かって伸びかつ前記バックスパンに向かって上方に伸びる上記3による変形される変形可能な生体被吸収性ポリマーの外科用ステープル。
【0049】
5.バックスパン、未変形状態において前記バックスパンの両端から第1の方向でかつ実質的にこれと直角に伸びて各が尖端部において終わる第1及び第2の脚を有する変形可能な生体被吸収性ポリマーの外科用ステープルを変形させる方法にして;
まず第1及び第2の脚を各脚がバックスパンと曲がり部との間の真っすぐな部分を有する状態で各脚に曲がり部を形成するように互いに内向きに変形させ;更に
その後で各脚において曲がり部から始まって尖端部に伸びている湾曲部分を第1の方向に定められかつバックスパンを通る垂直面と交差して伸びている円弧状であって各脚の湾曲部分が互いに交差している形状に変形させる
諸段階を含んだ方法。
【0050】
6.それぞれの尖端部が反対側の脚の曲がり部とバックスパンの下側との間に伸びるように各脚の湾曲部分を変形させる段階を更に含んだ上記3による方法。
【0051】
7.各脚の真っすぐな部分の長さを調整するためにステープルに始めに加えられる変形力を調整する段階を更に含んだ上記6による方法。
【0052】
8.バックスパン、未変形状態において前記バックスパンの両端から第1の方向でかつ実質的にこれと直角に伸びている第1及び第2の脚を有する変形可能な外科用ステープルの変形用のアンビルにして;
長手方向中心線を有しかつ水平面内のステープル受け面を有する支持体;
各が前記ステープル受け面に置かれた入り口端より出発し、前記ステープル受け面の下方の前記本体内の凹まされた部分に続き、そして前記ステープル受け面における出口端において終わる第1及び第2のポケット凹所であって、各が円弧状部分を有しかつ各の入り口端が実質的に長手方向中心線上に置かれかつ各の出口端が他方のポケット凹所の出口端が置かれた側とは長手方向中心線の反対の側に置かれるようにして同一線上でなく伸びている前記第1及び第2のポケット凹所であり、更に前記円弧状部分が曲がり部を形成するように湾曲しかつほぼ長手方向中心線上で互いに交差している前記第1及び第2のポケット凹所
を備え、
前記アンビルに向かって駆動されかつそれぞれ第1及び第2のポケット凹所の入り口端に受け入れられたステープルの第1及び第2の脚がバックスパンに向かって変形されかつ第1及び第2の脚の末端が反対側の脚の曲がり部とバックスパンとの間を伸びるように形成されるようにその出口端に案内されるアンビル。
【0053】
9.前記第1及び第2のポケット凹所がステープルの脚の尖端部を受け入れる逃げ溝を有し、前記逃げ溝はステープルの脚の幅よりも小さな幅を有し、従って尖端部はその底面と接触しえない上記8によるアンビル。
【0054】
10.前記支持本体及びその前記ポケット凹所が射出成型されたプラスチックで形成される上記9によるアンビル。
【図面の簡単な説明】
【図1】例えば、ステンレス鋼又はチタンで作られた通常の金属ステープル列の正面図である。
【図2】通常のステープルの変形後の形状の正面図である。
【図3】通常の2部品式生体被吸収性ポリマーステープルの正面図である。
【図4】既に変形された状態における変形可能な生体被吸収性ポリマーステープルの正面図である。
【図5】図4に示されたステープルの平面図である。
【図6】本発明による変形可能な生体被吸収性のポリマーステープルの未変形状態における正面図である。
【図7】本発明による変形可能な生体被吸収性のポリマーステープルがその変形された状態において組織の二つの層を把持している場合の断面側面図である。
【図8】本発明による図7に示された形状に変形されたステープルの平面図である。
【図9】本発明により形成された外科用ステープル器具のアンビルの図式的な図面である。
【図10】図9に示された外科用ステープル器具のアンビルの図式的な平面図である。
【図11】図9及び10に示された外科用ステープル器具のアンビルの図10の円弧面A−Aにおいて得られた垂直方向断面図である。
【符号の説明】
30 ブランク
32 バックスパン
36 尖端部
40 第1の部分
42 第2の部分

Claims (1)

  1. バックスパン、未変形状態においてバックスパンの両端から第1の方向でかつ実質的にバックスパンと直角に延びている第1及び第2の脚を有する変形可能な外科用ステープルの変形用のアンビルであって該アンビルが、
    長手方向中心線を有しかつ水平面内のステープル受け面を有する支持体
    ステープル受け面に置かれた入り口端より出発し、ステープル受け面の下方の該支持体内の凹まされた部分に続き、そしてステープル受け面における出口端において終わる第1及び第2のポケット凹所であって、円弧状部分を有しかつ入り口端が実質的に長手方向中心線上に置かれかつ一方の出口端が他方のポケット凹所の出口端が置かれた側とは長手方向中心線の反対の側に置かれるようにして同一線上でなく延びている第1及び第2のポケット凹所であり、更に円弧状部分が曲がり部を形成するように湾曲しかつほぼ長手方向中心線上で互いに交差している第1及び第2のポケット凹所を備え、
    ここで、該アンビルに向かって駆動されかつそれぞれ第1及び第2のポケット凹所の入り口端に受け入れられたステープルの第1及び第2の脚がバックスパンに向かって変形されかつ第1及び第2の脚の末端が反対側の脚の曲がり部とバックスパンとの間を延びるように形成されるようにその出口端に案内されるアンビル。
JP18089893A 1992-06-30 1993-06-25 結び形状を有する変形可能な生体被吸収性プラスチツクのステープル及びかかるステープルを変形させる方法及び装置 Expired - Lifetime JP3771282B2 (ja)

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EP0580994A1 (en) 1994-02-02
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JP2006102535A (ja) 2006-04-20
US5258009A (en) 1993-11-02
DE69314254D1 (de) 1997-11-06
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