JP2010279731A - 材料固定装置 - Google Patents
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- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/08—Muscles; Tendons; Ligaments
- A61F2/0811—Fixation devices for tendons or ligaments
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B2017/00831—Material properties
- A61B2017/00862—Material properties elastic or resilient
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- A—HUMAN NECESSITIES
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- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0409—Instruments for applying suture anchors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0412—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from suture anchor body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0414—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having a suture-receiving opening, e.g. lateral opening
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
- A61B2017/0435—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
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- A—HUMAN NECESSITIES
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- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
- A61B2017/0427—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
- A61B2017/0437—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body the barbs being resilient or spring-like
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/0805—Implements for inserting tendons or ligaments
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/0847—Mode of fixation of anchor to tendon or ligament
- A61F2002/0852—Fixation of a loop or U-turn, e.g. eyelets, anchor having multiple holes
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/0847—Mode of fixation of anchor to tendon or ligament
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/0882—Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
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- A—HUMAN NECESSITIES
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2002/0876—Position of anchor in respect to the bone
- A61F2002/0888—Anchor in or on a blind hole or on the bone surface without formation of a tunnel
Abstract
【解決手段】本発明は、骨内に構成された空間内に配置可能なインプラントを有する材料固定装置に関する。インプラントは、長手方向軸線を有する本体と、本体に配置された第1の部材及び第2の部材を有する。第1の部材及び第2の部材は、外方に移動するように拡張可能であり、第2の部材は、第1の部材から軸線方向に配置される。本体の遠位部端は、軟質の組織を受入れるスペースを、遠位端部を貫くように有する。インプラントは、更に、楔部を有し、第1の部材及び第2の部材の少なくとも一方を展開させるために、第1の部材及び第2の部材に対して軸線方向に移動可能である。
【選択図】図48A
Description
本発明の例示の装置実施形態は、腱を骨に縫合固定する必要なしに、腱又は他の軟組織を骨に直接固定することを可能にする様々な骨アンカーを提供する。従来の骨アンカーは、一般的に、隣接した組織を骨にピン留めすることを可能にするタックであるか、又は、軟組織を骨に間接的に取付けるために骨に縫合を取付け且つその縫合を軟組織に取付ける縫合アンカーであった。本発明のインプラント実施形態は、腱又は他の軟組織を骨トンネル又は孔内に直接保持して安定化させるために、アンカー自体(取付けられた縫合でなはく)を用いる直接取付け手法を提供する。
直接式アンカーの挿入は、対応する機器トレイの使用で標準化することができる。最初の処置工程は、腱又は他の軟組織を挿入して直接式アンカーが固定される骨孔の正確な位置及び方向決めを可能にするガイドピンの使用を含む。適切な大きさのカニューレ挿入ドリルを、ガイドピンの上を伝わらせてドリル孔を生成するのに用いることができる。ドリルは、アンカーの正確な深さを可能にする深さ止めを有する。トレイは、直径3mm〜12mmまでの範囲の様々なドリル寸法を保持することができる。最後に、トレイは、ドリル孔内の骨に直接固定されることになる腱の直径を判断するのに用いる装置を有することができる。
本明細書に説明した例示の方法及び装置を用いて腱固定を実施するために、領域のアクセスのための部位及び/又は関節鏡ポータルの標準手術準備が行われる。処置を関節鏡的に実施する場合、関節は、関節鏡流体で拡張される。開口処置を用いるとき、装置は、片手で容易に操作して展開することができる。関節鏡処置のために、展開装置は、設けられた標準5、6、又は8mmのカニューレを通って関節内に導入される。カニューレ寸法の範囲は、2〜11mmになる。
この技術は、利用することができる腱の長さが限定される場合に用いられる。この技術は、腱の端部を準備し、それをアンカーに縫合するために開口外科的切開を必要とする。〔B.二重腱ストランド技術〕
この技術は、利用することができる腱が豊富であり、又は腱がその中間点で固定を必要とする時に用いられる。
〔C.滑りアンカー技術〕
この技術は、骨トンネルの外に突出している腱の固定を可能にする。腱とアンカーの構成体を同時にトンネル内に押し込むのではなく、アンカーを展開前に腱に沿って(又は腱と共に)所定の位置に滑らせる。
〔D.腱板修復技術〕
この技術は、腱板縁を骨トンネル内に引き入れるプーリとして作用するインプラントの形状を用いる。
一部の腱の腱固定術は、腱の長さによって限定される。肘の末端二頭筋の修復は、この種類の処置の例である。この場合、腱は、展開アンカーと腱の間の2点圧縮を達成するのに十分長くない可能性がある。2点圧縮は、以下に説明するように、本発明の実施形態を用いる他の技術によって達成され、即ち、アンカーの周りの腱のループを形成することによって、直接式アンカーが腱の2つのセグメントに係合させ、腱を骨組織に直接押付ける。
多くの腱固定術処置は、同時に2つの腱ストランドの固定を必要とする。更に、一部の腱固定術処置は、同時に2つの腱を固定し、次に、必要でない腱のアームを切断することにより、更に容易に実施することができる。この変化は、2点の腱から骨への押付けを可能にし、治癒を促進する腱と骨組織の間の接触表面積を増加させる。
一部の外科的処置は、骨トンネル内で及び/又は腱ストランドが骨トンネルから延びるとき、腱ストランドの固定を必要とする。ここで腱は、両側から設けられており、異なる方向からの固定を必要とする。別の時には、腱を既に孔の中に挿入している場合があり、その現在の位置での単なる固定を必要とするであろう。修正アンカー(滑りアンカー)は、この固定を設けるために用いることができる。この種類の固定が必要である例は、ハームストリング前十字靱帯再建の脛骨固定及び肘側副靱帯再建の上腕骨固定である。
腱板断裂の修復は、このインプラントの独特な形状を利用して実施することができる。腱板断裂を修復してトラフにすることは、多くの場合に開口処置中に用いる技術であるが、関節鏡的に実施するのは困難である。このアンカーの形状は、滑り縫合技術を利用して腱板修復をトラフにするのを容易にする。
腱固定術アンカーは、軟組織対骨の固定を含む他の用途に用いることができることを認めるべきである。本明細書及び図面に示すように、本発明の実施形態は、人体構造に対して調整される。更に、本発明はまた、馬、犬、羊、及び豚、並びに無脊椎動物などの他の種における用途に調整することができる。当業者は、人間以外の動物に適合し又は適切であるように、必要以上の実験なしに本明細書に説明した例示の実施形態を再確認することができる。このような人間でない対象における用途の新しい構成も本発明の範囲及び精神に該当する。
図1A及び図1Bはそれぞれ、直接式腱アンカーの例示の実施形態を用いたハームストリング(膝腱)前十字靱帯(ACL)再建部の側面図及び側面断面図を示し、この実施形態は、ACL移植片の近位側を大腿骨11に固定し且つその遠位側を脛骨12に固定するのに使用されている。図2は、図1A及び図1Bに示すACL再建部の正面図を示す。図1A、図1B及び図2に示すように、例示の1つの直接式腱アンカー17は、脛骨12を貫通し且つ大腿骨11の中を部分的に通るように形成された骨ドリル孔18の中に腱アンカー17を挿入することによって、巻かれた2本のストランドハームストリング移植片13を大腿骨11に固定するのに用いられる。ハームストリング移植片ストランド13の自由端部を脛骨12に固定するための3つの直接式腱アンカー15が示されている。移植片を骨ドリル孔内に固定するのに、任意の数(1〜5)の直接式腱アンカーを用いることができることに注目すべきである。
アンカー及び展開器具構成要素は、弾性を有する、又は、変形可能であるのがよい。従って、アンカー又は展開器具構成要素は、様々な材料から製作することができ、係る材料は、例えば、形状記憶合金(例えば、ニッケルチタン(ニチノール))、形状記憶ポリマー、ポリマー(例えば、PTFE、ポリウレタン、ウレタン、シリコーン、ポリイミド、ポリプロピレン、ポリ乳酸、ポリグリコール酸、又は他の熱硬化性又は熱可塑性又はエラストマー性材料)、及び金属又は合金(例えば、チタン、CoCrMo、ステンレス鋼、その他)である。一部の実施形態では、装置アンカー構成要素は、吸収性であるのがよく、他の実施形態では、装置構成要素は、吸収性が限定された又は全くない特性を有していてもよい。本明細書に説明したアンカー構成要素は、部分的に1つの材料で作られてもよいし、全体的に1つの材料で作られてもよい。変形例として、アンカー又は展開器具の構成要素は、金属及び/又はポリマー構成要素で構成され、複合装置に製作されてもよい。例えば、小さい表面積で薄い金属又は金属合金構成要素は、ポリマー(例えば、ポリプロピレン)とインサート成形され、複合装置を生成することができる。
Claims (7)
- 骨内に構成された空間内に配置可能なインプラントを有する材料固定装置であって、
前記インプラントは、長手方向軸線、遠位端部及び近位端部を有する本体と、
前記本体に配置された第1の部材を有し、前記第1の部材は、外方に移動するように拡張可能であり、前記第1の部材をそれに隣接した軟質の組織又は骨に接触するように外方に拡張させたときの実質的に最も外側の接触部分を有し、
前記インプラントは、更に、前記本体に配置された第2の部材を有し、前記第2の部材は、前記第1の部材から軸線方向に配置され、外方に移動するように拡張可能であり、前記第2の部材をそれに隣接した軟質の組織又は骨に接触するように外方に拡張させたときの実質的に最も外側の接触部分を有し、
前記インプラントは、更に、前記本体の遠位端部を有し、前記本体の遠位部端は、軟質の組織を受入れるスペースを、前記遠位端部を貫くように有し、前記スペースは、前記長手方向軸線と略平行である前記本体の表面と前記長手方向軸線を横切る方向の前記本体の表面の両方によって定められ、
前記インプラントは、更に、楔部を有し、前記楔部は、前記第1の部材及び前記第2の部材の少なくとも一方を展開させるために、前記第1の部材及び前記第2の部材に対して略軸線方向に移動可能であり、前記第1の部材の実質的に最も外側の接触部分及び前記第2の部材の実質的に最も外側の接触部分は、前記本体に沿って軸線方向に異なる位置にある、材料固定装置。 - 前記第2の部材は、前記第1の部材よりも遠位側に配置される、請求項1に記載の材料固定装置。
- 前記第2の部材は、常に、前記遠位端部よりも近位側に配置される、請求項1に記載の材料固定装置。
- 前記第1の部材は、外方に枢動可能なアームを有し、前記アームは、前記本体を骨に固定するために骨に係合するように構成された部分を有する、請求項1に記載の材料固定装置。
- 前記アームの遠位端は、本体に取付けられ、枢動端部を有し、
前記アームの近位端は、外方に枢動し、且つ、骨に係合するように構成される部分を有する、請求項4に記載の材料固定装置。 - 前記第1の部材は、複数の前記アームを有する、請求項4に記載の材料固定装置。
- 前記第2の部材は、折り曲げ位置に作動される中央部分を有し、前記中央部分は、外方に拡張される、請求項1に記載の材料固定装置。
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2005
- 2005-11-18 US US11/281,566 patent/US7651528B2/en not_active Expired - Fee Related
- 2005-11-18 JP JP2007543300A patent/JP4603047B2/ja not_active Expired - Fee Related
- 2005-11-18 AU AU2005306450A patent/AU2005306450B9/en not_active Ceased
- 2005-11-18 WO PCT/US2005/041924 patent/WO2006055823A2/en active Application Filing
- 2005-11-18 EP EP05851848.1A patent/EP1824395B1/en not_active Not-in-force
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2009
- 2009-12-09 US US12/634,581 patent/US8435294B2/en active Active
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Also Published As
Publication number | Publication date |
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US20060155287A1 (en) | 2006-07-13 |
EP1824395B1 (en) | 2019-07-03 |
WO2006055823A3 (en) | 2006-09-08 |
JP4589457B1 (ja) | 2010-12-01 |
US20100152850A1 (en) | 2010-06-17 |
AU2005306450A1 (en) | 2006-05-26 |
AU2005306450B2 (en) | 2011-09-29 |
WO2006055823A2 (en) | 2006-05-26 |
JP2008520372A (ja) | 2008-06-19 |
US8435294B2 (en) | 2013-05-07 |
AU2005306450B9 (en) | 2012-02-02 |
US7651528B2 (en) | 2010-01-26 |
JP4603047B2 (ja) | 2010-12-22 |
EP1824395A2 (en) | 2007-08-29 |
EP1824395A4 (en) | 2012-07-18 |
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