JP5159918B2 - 医療用打ち込み式ステープル - Google Patents
医療用打ち込み式ステープル Download PDFInfo
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Description
固定力を高めるため脚部に溝やギザギザをつけたステープルは、特許文献2に開示されている。
現在使用されている、医療用打ち込み式ステープルの問題点として固定力の不足が指摘されており、手術後にステープルが転位やゆるみを生じ、固定していた腱や靱帯、骨などに「ずれ」をきたす場合がある。
上記の問題点を解決するため、固定力の増強が期待でき、手術手技、固定手技が容易で、手術において固定方法の選択肢を広げることができ、プレートやスクリュー固定の代用ともなりうる、医療用打ち込み式ステープルが求められている。
前記脚部のうち前記結合部側の一部を湾曲させずに直線状としてもよい。また、前記一対の脚部の長さを異ならせてもよい。
また、前記一対の脚部間にさらに1または複数の相互に間隔を同じに保ったまま該一対の脚部と同一方向に延びている前記一対の脚部より短い直線状の脚部を設けてもよい。また、前記一対の脚部の先端側に該脚部から枝状に延びる枝部を設けてもよい。
前記脚部の一部又は全部を、前記直線状の体部側から先端部側にかけて細くなるテーパ状としてもよい。また、前記体部及び脚部の全部又は一部を中空構造としてもよい。
前記体部から前記脚部が延びる部分より外側の端部側に、それぞれスクリューが挿入できる穴を設けてもよい。
また、手術の際に骨を固定するとき複数のステープルを用いることがあるが、このような場合、ステープルの体部を「三角形状」や「四角形状」とし、それぞれの角部から延びる湾曲した脚部を設ければ一本のステープルで対応可能となり、手術の簡略化を図ることができる。
さらに、例えば、骨粗鬆症が強い場合等にはスクリュウー穴を設けることにより強固な固定を得ることができる。
ステープルAは、骨折や骨切りの手術において腱や靭帯を骨片に固定する際に用いられている。手術において骨に固定された損傷靱帯や損傷腱には通常引張り力が加わる。しかし、この引張り力が強いと、またはステープルの固定力が弱いと、固定された靱帯や腱が単独で若しくはステープルと共に引き抜け、または脱転するトラブルが生じてしまう。
図10(b)は、実施例1による打ち込み式ステープルBの正面図及び側面図である。正面から見るとコの字形であるが、側面から見ると脚部B31、B32は紙面に対して垂直方向上方に湾曲している。なお、紙面に対して下方に湾曲してもよい。このような湾曲形態は以下の実施例においても同様である。
図11(c)は、2つの骨片101と102を本発明の実施例1による打ち込み式ステープルBによって固定したときの断面図を示したものである。このように骨片101及び骨片102の両方に本発明のステープルを用いて固定すれば、回転力及び引っ張り力に対する抵抗力は相乗的に増大する。
図12(a)に示すように引張り力が加わっても、脚部B31、B32が湾曲しているため骨に対する係止力が増し、固定力が増大する。靭帯や腱が矢印α方向に引っ張られた場合、ステープル脚部の先端にも矢印β方向に同様の力がかかると推察される。このときステープルの体部には矢印αと反対方向の力が働き、ステープルの挿入の度合いや湾曲具合、力のかかり具合によって、ステープル本体が矢印αと反対方向に倒れ込み、矢印γ方向に靭帯や腱を押さえようとする力が働き、固定力が増強される。
なお、図12(a)の場合、ステープルの湾曲に沿ってステープルが抜け出ようとする方向に力が作用する場合がある。しかし、固定しようとする靭帯や腱、骨にどのような力がかかるかを予測してステープルの挿入方向を選択すれば、固定力を増強することができる。
また、脚部B31、B32の方向や長さを調整することによって骨内での脚部の固定力を高めることができる。
図13に示す打ち込み式ステープルCにおいて、C1は体部、C21、C22は結合部、C31、C32は脚部、C41、C42は先端部である。そして、さらに脚部C31、C32は、脚部の直線状部の端部と前記湾曲部を接続する部分C31a、C32aを有する。
なお、図14(b)に示すように、脚部D31と脚部D32の間に複数本の脚部D331〜D33nを設けてもよい。
なお、この場合も、図15(b)に示すように、脚部E31と脚部E32の間に複数本の脚部E341〜E34nを設けてもよい。
図16に示す打ち込み式ステープルFにおいて、F1は体部、F21、F22は結合部、F31、F32は脚部、F41、F42は先端部である。図16に示されているように、脚部F31、F32は結合部F21、F22から直線状の体部F1に対して同一方向に垂直方向に伸びており、相互の間隔を同じに保ったまま同一方向に湾曲している。この実施例では、脚部F31とF32の長さが異なっている。なお、2つの脚部のうちどちらの脚部を短くしてもよい。
なお、先端部に枝部を設ける構成は、図13−図16に示されている実施例2−5にも適用することができる。
図18に示す打ち込み式ステープルHにおいて、H11−H14は体部であり、四角形状となっている。四角形状の体部の角部からは、それぞれ脚部H31−H34が前記四角形の体部が形成する平面に対して相互の間隔を同じに保ったまま同一方向に垂直に延びており、該脚部は該脚部の延長方向に対して垂直かつ同一方向に湾曲している。さらに、該脚部は前記四角形状の体部を形成する直線状の部材の任意の1つ(例えば、H1 2 )に対しても垂直方向に湾曲している。このように4本の脚部を設けることによって固定力がさらに向上する。
図19に示す打ち込み式ステープルJにおいて、J11−J13は体部であり、三角形状となっている。三角形状の体部の角部からは、それぞれ脚部H31−H33が前記三角形の体部が形成する平面に対して相互の間隔を同じに保ったまま同一方向に垂直に延びており、該脚部の延長方向に対して垂直かつ同一方向に湾曲している。さらに、該脚部は前記三角形状の体部を形成する直線状の部材の任意の1つ(例えば、J1 3 )に対しても垂直方向に湾曲している。このように3本の脚部を設けることによって固定力がさらに向上する。
図20に示す打ち込み式ステープルKにおいて、テーパ状の脚部は体部側から先端部側にかけて細くなっている。脚部をテーパ状とすることは、図10−図19に示された実施例1−8の脚部に適用することができる。
図20では脚部K31とK32のみテーパ状となっているが、すべての脚部又は任意の一部の脚部をテーパ状にしてもよい。
図21に示す構造は、図5−図19に示された実施例1−8の脚部又は先端部に適用することができる。
このような現象を避けるため、固定する靭帯や腱等とステープルとの間の滑り止めとして、図21(b)に示すように、ステープルの体部に小さな脚部又は突起を設けることがある。同様の目的で、靭帯や腱等を折り返して糸又は細い縫合用の針金をかけて縫合することもある(図21(c))。
その場合、ステープルの体部を中空にすれば、図21(d)に示すように靭帯や腱等に糸又は細い縫合用の針金をかけた後、これら糸又は針金を中空部分に通すことができ、固定する靭帯や腱等とステープルとの間の滑り止め効果及び固定力を向上させることができる。
なお、図21(a)ではステープルの脚部を湾曲させているが、脚部を直線状にしてもよい。
図22(a)に示す打ち込み式ステープルMにおいて、外側に延びた体部M1の両端にスクリュー穴M11aとM12aが設けられている。M31、M32は脚部である。
図22(b)は正面図であり、脚部M31とM32が体部M1から垂直に下方に延びている。また、外側に延びた体部M1の両端にはスクリュー穴M11aとM12aが設けられており、この穴を通してスクリューb1とb2が挿入できるようになっている。
しかし、図23(b)に示すように、スクリューを骨片に挿入する際に、骨折部である骨片間が固定されていないため、骨片が下方にずれてしまうことがある。また、固定した後にスクリューと平行な方向に引張り力が働くと、骨片が脱落する恐れがある。
なお、図22に示すスクリュー穴を備えた構造は、図13−図21に示された実施例2−10の体部に適用することができる。なお、図18に示す実施例7及び図19に示す実施例8のステープルの場合、角部から外側に体部を延ばし、延びた体部の各端部側にそれぞれスクリューが挿入できる穴を設けることができる。
なお、脚部の曲率半径は脚部全体で同じである必要はなく、例えば、脚部の上部と下部の曲率半径を異ならせてもよい。
本発明によるステープルの材質としては、チタン合金、ステンレス等、生体内に挿入されて有害でないと認められており、かつ固定力があるものであればよい。
2 ステープルの角部
3 ステープルの脚部
4 ステープルの先端部
10 骨
20 腱、靱帯
Claims (10)
- 直線状の体部と、該体部において所定の間隔を有した一対の結合部から相互に間隔を同じに保ったまま該直線状の体部に対して垂直に同一方向に延びている一対の脚部を備えた医療用打ち込み式ステープルであって、該一対の脚部は該脚部の延長方向及び前記直線状の体部に対して垂直かつ同一方向に湾曲している、医療用打ち込み式ステープル。
- 前記脚部のうち前記結合部側の一部が直線状である、請求項1に記載の医療用打ち込み式ステープル。
- 前記一対の脚部間にさらに1又は複数の相互に間隔を同じに保ったまま該一対の脚部と同一方向に延びかつ同一方向に湾曲している脚部を備えた、請求項1に記載の医療用打ち込み式ステープル。
- 前記一対の脚部間にさらに1または複数の相互に間隔を同じに保ったまま該一対の脚部と同一方向に延びている前記一対の脚部より短い直線状の脚部を備えた、請求項1に記載の医療用打ち込み式ステープル。
- 前記一対の脚部の長さが異なる、請求項1に記載の医療用打ち込み式ステープル。
- 前記一対の脚部の先端部側に該脚部から枝状に延びる枝部を有する、請求項1に記載の医療用打ち込み式ステープル。
- 3本又は4本の直線状の部材により構成された三角形又は四角形の体部の各角部から、該三角形又は四角形の体部が形成する平面に対して相互に間隔を同じに保ったまま同一方向に垂直に延びている複数の脚部を備え、該脚部は該脚部の延長方向に対して垂直かつ同一方向に湾曲しており、さらに前記三角形又は四角形の体部を形成する直線状の部材の任意の1つに対して垂直方向に湾曲している、医療用打ち込み式ステープル。
- 前記脚部の一部又は全部が、前記直線状の体部側から先端部側にかけて細くなるテーパ状となっている、請求項1−7のいずれか1項に記載の医療用打ち込み式ステープル。
- 前記体部及び脚部の全部又は一部が中空構造となっている、請求項1−7のいずれか1項に記載の医療用打ち込み式ステープル。
- 前記体部の一対の結合部より又は角部それぞれ外側に該体部が延びており、該延びた体部の各端部側にそれぞれスクリューが挿入できる穴が設けられている、請求項1−8のいずれか1項に記載の医療用打ち込み式ステープル。
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