JP3611889B2 - 螺旋状の外科用鋲 - Google Patents
螺旋状の外科用鋲 Download PDFInfo
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- JP3611889B2 JP3611889B2 JP01878995A JP1878995A JP3611889B2 JP 3611889 B2 JP3611889 B2 JP 3611889B2 JP 01878995 A JP01878995 A JP 01878995A JP 1878995 A JP1878995 A JP 1878995A JP 3611889 B2 JP3611889 B2 JP 3611889B2
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Description
【産業上の利用分野】
本発明が関与する技術分野は外科用具、特に外科用鋲およびその使用方法に関する。
【0002】
【従来の技術】
外科用ステープルは外科技術においてよく知られている。これらのステープルは切り傷や創傷に接近する外科医によって幅広く使用されている。外科用ステープルは慣用の縫合糸の代わりに開業医が入手できる有用な代替物であることがわかっている。
【0003】
外科用ステープルはしばしば様々な外科的処置において使用される。例えば、鼠蹊ヘルニアを治療するための外科的処置を行う場合、ある一般的な技術は鼠蹊ヘルニア部分に生体適合性の外科用メッシュを貼ることである。これは典型的に外科用メッシュをヘルニア部分の周囲の組織および筋肉にステープルで留めることにより行われる。この処置において使用されるステープルは典型的にステンレス鋼、チタン、タンタルなどから作られた慣用の金属ステープルである。このような処置における金属ステープルの使用には幾つかの欠点が伴う。ある明らかな欠点は金属ステープルが患者の体内にずっと残留しうることである。さらに、神経が金属ステープルにより捉えられ、圧迫されることは珍しくない。このことは患者に痛みを残しうると考えられている。このような痛みを軽減するために、ステープルを除去および/または交換するその後の手術が必要である。
【0004】
慣用のステープルの他の欠点はこのような慣用のステープルの保持力がステープルワイヤの大きさとその材料の堅さおよび機械的性質により制限されることである。より大きなそして/またはより堅い金属ステープルは慣用の外科用装置のアンビルの周りに曲げることがより難しく、そのためその強度が制限される。幾つかの場合において、慣用の金属ステープルは強くない、またはあまり大きくないため組織から引き抜くことができる。
【0005】
吸収性ステープルの使用はこれらの問題を克服する手助けになり、また例えば吸収性ステープルはしばらくすると吸収され、それにより圧迫された神経にかかる圧力が緩和されるため追加の外科的処置を行う必要がない。吸収性ステープルは当該技術分野において知られているが、このようなステープルは典型的にクラウンおよび脚を有する上部と下部の受け口からなるため組織部分の両側に近づく必要がある。下部の受け口はステープルの脚とかみ合い、ロックする。したがって、当該技術分野において知られている吸収性ステープルは典型的に組織の片側に近づくだけの鼠蹊ヘルニアの治療のような外科的処置に使用することができない。下部の受け口を必要としない他のタイプの吸収性ステープルは1993年11月2日に出願され、一般譲渡された共同未決米国特許出願第146,755号(参考文献として本明細書に組込まれる)に記載されている3個構成ステープルである。
【0006】
【発明が解決しようとする課題】
当該技術分野において、組織の所定の位置に留め具をロックまたは保持するため第2の分離した部品または受け口を必要とせず、内視鏡によるまたは切開する外科的処置において組織部分の片側に適用し、固定することができ、そして慣用の外科用ステープルに伴う欠点を克服する外科用締結具が要求される。
したがって、本発明の目的は留め具を組織にロックまたは保持するための追加の部材を必要としない外科用留め具を提供することである。
【0007】
本発明の別の目的は容易に組織と組織を、縫合糸と組織を、またはメッシュのような外科用具と組織を結び付ける外科用鋲を提供することである。
本発明のさらに別の目的は鋲が組織の片側から挿入される結び付けに使用することのできる外科用鋲を提供することである。
また、本発明のさらに別の目的は外科用鋲を使用して組織を結び付ける方法を提供することである。
【0008】
【課題を解決するための手段】
したがって、外科的処置に使用される外科用鋲が開示される。外科用鋲は上部および底部を持つベース部材を有する。任意の縫合糸取付け部材はベース部材から伸びている。ある部材はベース部材の底から伸びている。本部材は軸線および空間により隔てられた多数のループを有する螺旋に形成される。本部材は近端部および遠端部を有する。好ましくは、本部材は少なくとも1つの外方に伸びている縁を有する。本部材はその遠端部から伸びている孔抜き先端を有する。孔抜き先端は軸線と実質的に平行に伸びており、またはそれに関して角を付けることができる。本部材は半円筒形の断面、三角形の断面、放物形の断面および長方形の断面など様々なタイプの断面を有する。螺旋は少なくとも1つのコイルからなる。コイルは円形、正方形、三角形または多角形の形状を有する。場合によっては、様々な形のくぼみ、例えば溝などが鋲打ちを容易にするためベース部材の上面に形成されうる。
【0009】
本発明のさらに別の局面は組織を留める方法である。本法は上記の鋲を組織の片側に挿入することからなる。組織と組織、縫合糸と組織、または外科用メッシュなどの医療用具と組織を結び付けるために鋲が使用されうる。
【0010】
本発明の他の特徴および利点は次の記載および添付図面からより明らかになるであろう。
本発明の外科用鋲は図1〜19に示される。最初に、図1〜4に言及すると、鋲10はベース部材20を有する。ベース部材20は上面30、底面40および上面30と底面40をつなぐ側面25を有する。ベース部材20は好ましくは円板のような形状を有するが、長方形、正方形、六角形および多角形などの他の形状のものを使用してもよい。ベース部材20は遠方に伸びている螺旋の製造を容易にするため固体であったり、またはそれを貫通する穴を持つことができる。ベース部材20の上面30は鋲打ちを容易にするためその中に形を造ることができる(図8〜11参照)。これらの形はそれぞれ溝形ねじ廻し、アレン(Allen )型、フィリップス(Phillips)型またはトルクス(Torx)型ねじ廻し、あるいは鋲10に回転を与える四角のまたは他の工具に合うくぼみ31,32,33および34のようなくぼみからなる。遠方に伸びている螺旋部材50はベース部材30の底面40から下方に伸びている。遠方に伸びている部材50は好ましくは一定の大きさのコイル65を有する螺旋を形成するように造形されるが、所望ならばコイルの大きさは螺旋の縦方向に沿って変化することができる。コイル65は一定のまたは螺旋の軸線に沿って変化するギャップにより隔てられている。部材50は近端部52および遠端部54を有する。貫通手段としての孔抜き先端58は遠端部54から伸びている。孔抜き先端58は効果的に組織を突き通すのに十分な慣用の鋭い孔抜き先端形状を有することができる。
【0011】
孔抜き先端58はまた、組織を突き通すのに有用な太くて短い形状を有することができる。孔抜き先端58は螺旋60の軸線と平行に配置することができ、または組織への貫通を容易にするため螺旋の軸から斜方向に先を向けることができる。部材50または先端58は組織中の鋲の保持力を増大する1つまたは複数のとげを有することができる。部材50は好ましくは少なくとも1つの縁59を有する。図4に言及すると、部材50は2つの外縁59を持つ実質的に半円筒形の断面を有する。図3および図4を見てわかるように、通路70が螺旋60の中に含まれる。
【0012】
本発明の外科用鋲10の別の態様は図5(a)に示される。鋲100は上面110および側面115を持つ六角形のベース部材105を有する。側面117は上面105と底面115をつなぐ。遠方に伸びている螺旋部材120は底面115から下方に伸びて螺旋128を形成する。図5(b)に示されるように、部材120は三角形の断面および3つの外縁122を有する。先端126は部材120の遠端部124から伸びている。
【0013】
本発明のさらに別の態様は図6(a)に示される。鋲130は上面132、底面134およびそれらをつなぐ側面136を有する。螺旋149を形成する螺旋部材140はベース部材131の底面134から遠方に伸びている。部材140は遠端部142、および遠端部142から伸びている貫通手段としての孔抜き先端144を有する。図6(b)に言及すると、部材140は外縁146を持つ実質的に放物形の断面を有する。
【0014】
本発明の鋲の別の態様は図7(a)に示される。鋲150はベース部材151を有する。ベース部材151は実質的に六角形である。ベース部材151は上面152、底面154およびそれらをつなぐ側面156を有する。螺旋169を形成する螺旋部材160はベース部材151の底面154から遠方に伸びている。部材160は縁162、遠端部164、および遠端部164から伸びている先端166を有する。図7(b)に言及すると、部材160は一般に外縁162を持つ実質的に長方形の断面を有する。
【0015】
本発明の鋲の螺旋部材は様々な形の螺旋に形成されうる。例えば、図1の鋲10は一定の直径の円形コイルを持つ円筒螺旋形である螺旋60を有する。さらに、本発明の鋲の螺旋は他の様々な幾何学的形状を有することができる。例えば、図12はベース部材210、およびコイル220が正方形である螺旋217に形成される螺旋部材215を有する鋲200を示す。貫通手段としての孔抜き先端225は螺旋217の軸線と垂直に向いている。
【0016】
図13に言及すると、鋲230はベース部材231、および三角形のコイル238を持つ螺旋236を形成する遠方に伸びている螺旋部材235を有する。貫通手段としての孔抜き先端240はコイル236の軸線と垂直に伸びている。螺旋の別の態様は図14に示される。鋲250はベース部材251、および一般に円形であり、螺旋253の縦方向に沿って直径が減少するコイル254を持つ螺旋253を形成する遠方に伸びている螺旋部材252を有する。先端255は一般に螺旋253の軸線と一直線にされる。図15には、図1の鋲10の別の態様が示される。鋲260はベース部材261、および円形で一定の直径のコイル264を持つ螺旋263を形成する下方に伸びている螺旋部材262を有する。貫通手段としての孔抜き先端265は螺旋263の軸線と実質的に垂直に向いている。
【0017】
縫合糸は様々な方法で本発明の鋲に付けることができる。図16に言及すると、鋲310は上面330および下方に伸びている螺旋部材350を持つベース部材320を有する。縫合糸の2つの端はベース部材320に取付けられ、ベース部材320の上面330から上方に伸びている。縫合糸は同時成形、結合、機械的固着、接着、溶接などの慣用の方法で取付けることができる。
【0018】
別の態様の縫合糸取付けが図17に示される。図17において、縫合糸300はベース部材20に隣接する本発明の鋲10の遠方に伸びている螺旋部材50の近端部の周りに結ばれる。
【0019】
本発明の鋲に縫合糸を取付けるための別の態様が図18に示される。上面421および底面422を持つベース部材420を有する鋲400が示される。螺旋部材450は底面422から下方に伸びている。縫合糸を入れる穴431を有する縫合糸取付け部材430はベース部材420の上面421から上方に伸びている。縫合糸300は縫合糸を入れる穴431に通される。縫合糸取付け手段を有するさらに別の態様の鋲が図19に示される。鋲460は遠方に伸びている保持部材としての端部485をそれぞれ持つ外方に伸びている外延部材としての部材480からなるベース部材470を有する。鋲はベース部材470の底面471から遠方に伸びている螺旋部材490を有する。縫合糸300はベース部材470の周りに取付けられ、下方に伸びている保持部材485の中に入れられる。
【0020】
本発明の外科用鋲は組織に近づき、例えば外科用メッシュなどの医療用具を組織の表面に保持するために、または組織を解剖部位に固定するために使用されうる。本発明の鋲は内視鏡による外科技術において有用な小さいサイズで製造されうる。鋲は大きな除去力に抵抗する。さらに、鋲は外科医が組織部分の片側にだけ接近する場合に使用されうる。本発明の鋲はステープルと違って組織を圧迫せず、また慣用のステープルおよび留め具の場合は典型的に一箇所につき2個の穴をあけるが、これらは留め具1個あたり1個の穴しかあけないため非外傷性の傾向がある。ステープルが適用または燃焼されると組織を押しつぶすステープルの使用はある場合において虚血をひき起こし、その結果ステープルが加える圧力に応じて壊死が生じることが知られている。さらに、殆どのステープルは非吸収性の材料から製造され、重要な癒合期間後も残留する。
【0021】
本発明の鋲は吸収性または非吸収性の材料から製造されうる。癒合過程中に体内に吸収され、それにより組織に近づいたり、それを留めたりするその機能をもはや活用する必要がなくなった時にその留め具を排除する。吸収性材料から本発明の鋲を製造することが特に好ましい。
【0022】
鋲10のような本発明の鋲は次のようにして使用される。鋲は慣用の外科用つかみ具、ねじ廻し、ナットドライバー、アレン型レンチまたは内部外科用つかみ具のような適当なつかみ具を用いて、あるいは手でつかむことができる。鋲10の先端58は組織の外面に押し当てられる。次に、鋲は曲がった部材を組織に固定するため回転される。鋲は軟質の筋肉、筋膜または脂肪から硬質の靱帯および腱まである様々なタイプの組織に使用されうる。
【0023】
本発明の鋲10は螺旋に形成されると効果的に鋲10を組織に固定するのに十分な大きさの断面を持つ螺旋部材を有する。例えば、鋲10は直径が約0.010インチ〜約0.075インチである円形の断面を持つ螺旋部材50を有してもよい。螺旋の長さおよびコイルの大きさは特定の用途および構成材料の性質に依存する。構成材料の機械的性質、例えば堅さは変形することなく効果的に鋲を組織に突き通すのに十分なものである。螺旋のコイルの主な寸法は鋲が固定される組織にとって適当なものであり、効果的に鋲の必要な保持力を与えるのに十分なものであり、そして鋲が施される方法に依存する。例えば、コイルの直径は約0.125インチ〜約0.250インチである。螺旋の長さおよび螺旋のコイルの数は必要な保持力、鋲が固定される組織の深さおよび組織の種類に依存する。コイルの数は0.5より大きいものである。当業者は最小限の日常実験により容易に特定用途のそれぞれについて最適な螺旋の長さ、コイルの主な寸法およびコイルの数が決定されることを理解するであろう。
【0024】
本発明の外科用鋲は慣用の生体吸収性材料、非吸収性材料、これらの組合せ、またはこれらの等価物から製造されうる。吸収性材料の例としては、ラクチド、グリコリド、トリメチレンカーボネート、カプロラクトンおよびp−ジオキサノンのホモポリマー、コポリマーおよびこれらのブレンドが挙げられる。次の2つのブレンドは特に有用である;
(1)米国特許第4,646,741号(参考文献として本明細書に組込まれる)に開示されているポリ(p−ジオキサノン)およびラクチド/グリコリドコポリマーのブレンド。
(2)米国特許第4,889,119号(参考文献として本明細書に組込まれる)に開示されており、一方のポリマーがラクチド含量の高いポリマーであり、そして他方がグリコリド含量の高いポリマーである2種以上のポリマーからなるグリコリドに富むブレンド。
【0025】
鋲はまた、ステンレス鋼、チタン、ポリマー、複合材料などの慣用の非吸収性で生体と適合しうる材料およびこれらの等価物から製造されうる。
【0026】
【実施例】
次の実施例により本発明を詳しく説明するが、本発明はそれらに限定されない。
(実施例1)慣用の外科的準備技術を使用して患者に手術の用意をさせる。有効な麻酔状態を引き起こすのに十分な投与量の慣用の麻酔薬を用いて患者に麻酔をかける。慣用の外科技術を使用して鼠蹊ヘルニア部分に近づくために患者腹腔を切開する。鼠蹊ヘルニア部分に慣用の外科技術を施した後、一片の慣用の生体と適合しうる外科用メッシュを鼠蹊ヘルニア部分の上に載せる。本発明の吸収性外科用鋲10は鋲10を適当な外科用つかみ具でつかみ、そしてその鋲10を留める対象の組織に近い位置に配置することにより施す。鋲10は慣用の吸収性ポリマー材料から製造される。螺旋部材50の貫通手段としての孔抜き先端58は組織の表面と実質的に垂直に位置する。次に、鋲10を先端58が組織を突き通すまでメッシュを通して深く押し進める。次に、鋲10をベース部材20の底面40がメッシュと接触するまで組織の奥深くまで移動するように回転させる。
【0027】
効果的にメッシュを固定するのに十分な数、例えば約15の鋲10を使用してメッシュを固定した後、鼠蹊ヘルニアの処置を慣用の方法で終了し、そして腹腔壁の切開部を慣用の縫合糸を使用して閉じる。外科用鋲10は鼠蹊ヘルニア部分の上に外科用メッシュを保持し、時間がたつと患者の体内に吸収される。
【0028】
本発明をその詳細な態様に関して図示し、説明したが、当業者には本発明の精神および範囲から逸脱することなくその形態および詳細において様々な変形をなしうることは理解されよう。
【0029】
本発明の具体的な実施態様は以下の通りである。
1)螺旋部材は実質的に半円筒形の断面を有する請求項1記載の鋲。
2)螺旋部材は実質的に三角形の断面を有する請求項1記載の鋲。
3)螺旋部材は実質的に放物形の断面を有する請求項1記載の鋲。
4)螺旋部材は実質的に長方形の断面を有する請求項1記載の鋲。
5)コイルは円形である請求項1記載の鋲。
6)コイルは三角形である請求項1記載の鋲。
7)螺旋は複数の円形コイルを含み、そしてコイルは螺旋の軸線に沿って直径が減少する前記実施態様5)記載の鋲。
8)孔抜き手段は螺旋部材の遠端部から伸びている先端からなる請求項1記載の鋲。
9)先端が螺旋の軸線と実質的に平行に伸びている前記実施態様8)記載の鋲。
10)先端が螺旋の軸線と実質的に垂直に伸びている前記実施態様8)記載の鋲。
11)縫合糸取付け手段はその中に縫合糸を入れる穴を有する近方に伸びている部材からなる請求項7記載の鋲。
12)ベース部材は円形である請求項1記載の鋲。
13)ベース部材は多角形である請求項1記載の鋲。
14)ベース部材は外縁および外縁から遠方に伸びている保持部材を有する2つの直交する部材からなる請求項1記載の鋲。
15)鋲打ち手段はベース部材の上面に鋲打ち工具に合う形状のくぼみを有する請求項8記載の鋲。
【0030】
【発明の効果】
以上説明したように、本発明によれば、外科的処置において使用される鋲が提供される。本発明の鋲はベース部材、その底から伸びている螺旋部材、および螺旋部材の遠端部から伸びている孔抜き手段で構成される。慣用のステープルと異なり、本発明の鋲はそれを組織に保持するための追加の部材を必要とせず、使用の際は組織の片側に挿入するだけでよく、しかも組織を圧迫しない。また、本発明の鋲は吸収性材料で製造することができるため体内に吸収される。
【図面の簡単な説明】
【図1】本発明の外科用鋲の斜視図。
【図2】本発明の外科用鋲の側面図。
【図3】螺旋を形成するためベース部材の底面から遠方に伸びている部材を示す本発明の外科用鋲の底面図。
【図4】線4−4に沿って取られた図3の外科用鋲の断面図。
【図5】(a)は六角形のベース部材を有する本発明の外科用鋲の別の態様を示す斜視図。(b)は部材の三角形の断面を示す、線5A−5Aに沿って取られた(a)の鋲の螺旋部材の断面図。
【図6】(a)は本発明の外科用鋲の別の態様を示す斜視図。(b)は部材の放物形の断面を示す、線6A−6Aに沿って取られた(a)の鋲の螺旋部材の断面図。
【図7】(a)は本発明の鋲の別の態様を示す斜視図。(b)は長方形の断面を示す(a)の鋲の螺旋部材の断面図。
【図8】慣用のねじ廻しの先を受けるための溝形くぼみを有する図1の鋲のベース部材の斜視図。
【図9】アレン型レンチの先を受けるためのくぼみを有する図1の鋲のベース部材の斜視図。
【図10】フィリップス型ねじ廻しの先を受けるためのくぼみを有する図1の鋲のベース部材の斜視図。
【図11】トルクス型ねじ廻しの先を受けるためのくぼみを有する図1の鋲のベース部材の斜視図。
【図12】螺旋が正方形のコイルを有する本発明の鋲の別の態様の底面図。
【図13】螺旋が三角形のコイルを有する本発明の鋲の別の態様の底面図。
【図14】螺旋が螺旋の軸線に沿って直径が変化する円形のコイルを有する本発明の鋲の別の態様の底面図。
【図15】螺旋部材が円形のコイルを有する螺旋に形成され、そして孔抜き先端が螺旋の軸線と垂直である本発明の鋲の別の態様の底面図。
【図16】その中に取付けられた縫合糸の端を有する図1の鋲の側面図。
【図17】螺旋部材に結ばれた縫合糸を示す図1の鋲の側面図。
【図18】ベース部材の上部から伸びている縫合糸取付け手段を有する本発明の鋲の別の態様を示す図。
【図19】縫合糸を取付けるために使用することもできる十字ビーム部材を持つベース部材を有する本発明の鋲の別の態様を示す図。
Claims (8)
- 上面および底面を有するベース部材と、
前記ベース部材の前記底面から遠方に伸びており、少なくとも1つの外エッジと遠端部とを備え、少なくとも1つのコイルと、軸線と、内部通路とを備える螺旋を形成する、螺旋部材と、
前記螺旋部材の遠端部から伸びている孔抜き手段と、
前記ベース部材に取付けられた縫合糸と、を有する、外科的処置において使用される鋲。 - 上面および底面を有するベース部材と、
前記ベース部材の前記底面から遠方に伸びており、少なくとも1つの外エッジと遠端部とを備え、少なくとも1つのコイルと、軸線と、内部通路とを備える螺旋を形成する、螺旋部材と、
前記螺旋部材の遠端部から伸びている孔抜き手段と、を有し、
前記螺旋部材は、実質的に三角形の断面を持ち、3つの外エッジを備える、外科的処置において使用される鋲。 - 上面および底面を有するベース部材と、
前記ベース部材の前記底面から遠方に伸びており、少なくとも1つの外エッジと遠端部とを備え、少なくとも1つのコイルと、軸線と、内部通路とを備える螺旋を形成する、螺旋部材と、
前記螺旋部材の遠端部から伸びている孔抜き手段と、を有し、
前記ベース部材は、外方に延びている外延部材と、遠方に伸びている保持部材とを持つ2つの直交する部材を備える、鋲。 - 請求項2または3に記載の鋲であって、
前記ベース部材に取付けられた縫合糸をさらに有する、鋲。 - 請求項1または3に記載の鋲であって、
前記螺旋部材は、実質的に三角形の断面を持ち、3つの外エッジを備える、鋲。 - 請求項1または2に記載の鋲であって、
前記ベース部材は、外方に延びている外延部材と、遠方に伸びている保持部材とを持つ2つの直交する部材を備える、鋲。 - 請求項1または2に記載の鋲であって、
前記ベース部材の前記上面から伸びている縫合糸取付け手段をさらに有する、鋲。 - 請求項1ないし7のいずれかに記載の鋲であって、
ベース部材に設けられ、組織への鋲打ちを容易にする手段をさらに有する、鋲。
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1995
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- 1995-01-11 CA CA002139979A patent/CA2139979A1/en not_active Abandoned
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- 1995-01-13 EP EP95300207A patent/EP0663184A1/en not_active Withdrawn
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1996
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AU1011595A (en) | 1995-07-20 |
US5728116A (en) | 1998-03-17 |
CA2139979A1 (en) | 1995-07-14 |
US6036701A (en) | 2000-03-14 |
US5904696A (en) | 1999-05-18 |
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