JP6612909B2 - 組織を骨に対して取付ける多重縫合糸式無結節アンカ及び関連方法 - Google Patents
組織を骨に対して取付ける多重縫合糸式無結節アンカ及び関連方法 Download PDFInfo
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Description
図1A及び図1Bは、夫々、一本以上の縫合糸により軟組織を骨に対して固着するアンカ・アセンブリ10を未展開形態及び展開形態で示している。図2A及び図2Bは、夫々、図1A及び図1Bに示されたアンカの断面図を示している。アンカ・アセンブリ10は、複数の構成要素(すなわち、スリーブ12、各翼部14、及び、本体16)を備えて示される。上記アンカの各構成要素は、相互に移動可能に協働することで、(a)縫合糸の各自由端部または各肢部に対して張力を付与することにより組織がアンカに向けて引き寄せられ得るという第1の未展開形態;及び、(b)アンカが骨内に固定され、且つ、縫合糸は該アンカ内に繋止されることにより上記組織を上記骨に対して固着するという第2の展開形態;を含む2つの形態を提供する。
図3A及び図3Bは、明瞭化のためにアンカ・アセンブリの他の構成要素が取り外されたアンカ本体すなわちプラグ構成要素16を示している。アンカ本体16は、基端区画42、長寸中間区画44、及び、組織貫通末端区画46を有して示される。上記プラグ構成要素の代表的な全長(L1)は、13.97〜19.05mm (0.55〜0.75インチ)の範囲であり、更に好適には約16.002mm(0.63インチ)である。
図4Aから図4Dは、アンカ・アセンブリのスリーブ構成要素12を示している。スリーブ12は、概略的に管状の形状と、該スリーブの基端64から末端66まで延在する内孔62とを有して示される。上記内孔は、一定の直径(D3)を有して示される。スリーブ12に対する例示的な直径(D3)は、2.667〜3.048mm(0.105〜0.120インチ)の範囲であり、更に好適には、約2.7432mm(0.108インチ)である。上記スリーブの例示的な長さ(L3)は、4.064〜8.89mm(0.160〜0.350インチ)の範囲であり、更に好適には、約6.35mm(0.250インチ)である。
図5Aから図5Dは、骨を繋止または固着する構造14を示している。骨繋止構成要素14は、外方に撓曲可能な3つのアームもしくは翼部72を有して示される。各アームは、末端区画または基礎部75から延在する。各翼部は、スロット74により夫々分離される。所定用途において、各翼部72は、撓曲することで骨に係合し、該骨内に上記アンカを固着する。
図6から図9は、植設されつつある縫合糸アンカを示している。示された如く、縫合糸28、29は予め、腱150を貫通して縫い付けられ、接続され、または、ループ形成されると共に、(例えば、スネアを用いてアンカを貫通して経路選定されて)アンカ132及び器具128内に装填され得る。器具128はまた、該器具の末端部分であるがアンカ翼部164の基端側であるという側部開孔もしくは開口140であって、該器具から上記アンカへの縫合糸28、29の通過を許容すべく作用し得るという側部開孔もしくは開口140も有し得る。縫合糸28、29は、アンカ132内で、開孔140から末端方向に、鳩目を貫通して組織150に至り、且つ、同一経路に沿い基端方向に戻り、且つ、該縫合糸は、(例えばアーム172などの)器具取手の一部に接続されることで、挿入及び張設の間において縫合糸28、29の取扱いを支援し得る。
図10Aから図10Dは、縫合糸アンカ構成要素の代替実施形態、特に、繋止プラグの代替実施形態210を示している。図10Aから図10Dに示された繋止プラグ210は、先端212が隆起部214を含むことを除き、上記に示されたものと同様である。各隆起部の寸法は、0.127〜0.381mm(0.005〜0.015インチ)の範囲である隆起部高さhr、及び、0.762〜1.27mm(0.030〜0.050インチ)の範囲である隆起部長さlrにより特性記述される。各隆起部214は、上記繋止プラグが骨内へと挿入され(または打ち込まれ)たときに骨の把持を支援する。
図12は、結合組織を骨に対して固着する医学的処置の各ステップを示すフローチャートである。この処置は、(例えば上腕骨骨頭などの)骨の一部に対して取付けられるべき(例えば回旋筋腱板腱などの)結合組織の一部に対し、臨床医に適すると思われる任意の方法を用い、所定長さの一本以上の縫合糸の結着肢部を固着するステップを含む(ステップ410)。
Claims (14)
- 軟組織を骨に対して少なくとも一本の縫合糸により無結節で固着する縫合糸用アンカであって、
当該縫合糸用アンカは、前記縫合糸の自由肢部に対して張力を付与することにより前記軟組織は当該縫合糸用アンカに向けて引き寄せられ得るという第1未展開形態、及び、当該縫合糸用アンカは前記骨内に固定され且つ前記縫合糸は当該縫合糸用アンカに繋止されることにより前記軟組織を前記骨に対して固着するという第2展開形態を備え、
当該縫合糸用アンカは、
アンカ本体であって、
末端先端であって、該末端先端を通して配置された縫合糸用孔を有する末端先端と、
挿入デバイスのシャフト末端に選択的に結合されるように構成された接続部分と、
前記末端先端から基端方向に延在する複数の撓曲区画とを有し、
前記撓曲区画の内側面がキャビティを画成し、該キャビティは、前記縫合糸用孔の全体から基端方向に配置された末端であって、中実断面を有する中間部分により前記縫合糸用孔から基端方向に離間される末端を有し、該キャビティは、前記撓曲区画が未拡開である前記第1未展開形態及び前記撓曲区画が外方に拡開された前記第2展開形態の両方のときに前記末端で終端する、
というアンカ本体と、
骨を係合するために前記撓曲区画を撓曲し、骨壁部と撓曲区画の外側面との間で縫合糸を圧縮することで前記縫合糸を前記縫合糸用アンカに繋止するように、前記アンカ本体と協働するように構成されたスリーブ部材と、
を備える、縫合糸用アンカ。 - 前記複数の撓曲区画は、複数の異なるサイズに拡開可能である、請求項1に記載の縫合糸用アンカ。
- 前記複数の撓曲区画は、前記スリーブ部材が前記キャビティ内へと付勢されたときに前記アンカ本体から外方に撓曲する、請求項1に記載の縫合糸用アンカ。
- 前記複数の撓曲区画は少なくとも3つの個別的な翼部を備える、請求項1に記載の縫合糸用アンカ。
- 前記末端先端は、テーパ付けされた先端を有する、請求項1に記載の縫合糸用アンカ。
- 前記アンカ本体は生体適合性ポリマである、請求項1に記載の縫合糸用アンカ。
- 前記スリーブ部材及び前記複数の撓曲区画の少なくとも一つは、外側隆起部を有する、請求項1に記載の縫合糸用アンカ。
- 前記キャビティは環状空間である、請求項1に記載の縫合糸用アンカ。
- 所定長さの縫合糸を骨に関して投錨する、無結節で縫合糸を投錨するシステムであって、
取手と、該取手から末端方向に延在する長寸の堅固なシャフトとを備えるアンカ挿入器具であって、前記シャフトは、螺条付き部分を画成する末端区画を備えるというアンカ挿入器具と、
前記長寸の堅固なシャフトの前記末端区画に取り外し可能に接続されたアンカ本体であって、器具螺条付き部分と選択的に協働する内部螺条付き部分と、末端先端であって該末端先端の厚みを通す開孔を有する末端先端とを有し、さらに、キャビティを画成する内側面を有する撓曲可能な骨投錨構造を有し、該キャビティは、前記開孔の全体から基端方向に配置された末端であって、中実断面を有する中間部分により前記開孔から基端方向に離間される末端を有する、アンカ本体と、
前記アンカ本体の基端方向にて前記アンカ挿入器具の前記シャフトの末端区画上に摺動可能に配設され、前記骨投錨構造を径方向に撓曲するに十分なサイズ及び形状の外径を有するスリーブ部材であって、骨を係合するために前記骨投錨構造を撓曲し、骨壁部と骨投錨構造の外側面との間で縫合糸を圧縮することで前記縫合糸を前記アンカ本体に繋止するように、前記アンカ本体と協働するように構成されたスリーブ部材と、
を備える、無結節で縫合糸を投錨するシステム。 - スネアの末端部分が前記所定長さの縫合糸に対して固着されたときに、該スネアを引き戻しは、前記アンカ本体の開孔と前記アンカ挿入器具の末端部分とを通して前記所定長さの縫合糸を引き寄せる如く、前記アンカ挿入器具の少なくとも一部分と前記アンカ本体の前記開孔とを通して延在するスネアを更に備える、請求項9に記載のシステム。
- 前記末端先端は、テーパ付けされた先端を有する、請求項9に記載のシステム。
- 前記キャビティは環状空間である、請求項9に記載のシステム。
- 前記アンカ本体の接続部分は、アンカ挿入器具に接続するための内部螺条付き部分をさらに有し、該内部螺条付き部分は、協働する挿入器具螺条付き部分と前記内部螺条付き部分との間における十分な応力の付与時に、前記螺条付き部分の一方あるいは両方を取り除き、また、所定張力で前記内部螺条付き部分の犠牲区画を破断するように、前記アンカ本体から分離されるように適合される、請求項1に記載の縫合糸用アンカ。
- 前記螺条付き部分の少なくとも一つは、前記アンカ挿入器具から前記アンカ本体を選択的に分離するように十分な応力の付与時に、取り除かれるように適合される、請求項9に記載のシステム。
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