JP2002503123A - 人工関節 - Google Patents
人工関節Info
- Publication number
- JP2002503123A JP2002503123A JP50140599A JP50140599A JP2002503123A JP 2002503123 A JP2002503123 A JP 2002503123A JP 50140599 A JP50140599 A JP 50140599A JP 50140599 A JP50140599 A JP 50140599A JP 2002503123 A JP2002503123 A JP 2002503123A
- Authority
- JP
- Japan
- Prior art keywords
- prosthesis
- fabric
- cylindrical body
- joint spacer
- joint
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/30—Joints
- A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
- A61F2/4241—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for hands, e.g. fingers
-
- 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
- A61F2/30—Joints
- A61F2/30721—Accessories
-
- 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
- A61F2/30—Joints
- A61F2/30756—Cartilage endoprostheses
-
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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
- A61F2/30—Joints
- A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
- A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
-
- A—HUMAN NECESSITIES
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- 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
- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
- A61B17/06166—Sutures
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
-
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
-
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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
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
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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
-
- 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
- A61F2/30—Joints
- A61F2/30721—Accessories
- A61F2/30724—Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
-
- 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
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
-
- 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
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
-
- 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
- A61F2/30—Joints
- A61F2/38—Joints for elbows or knees
- A61F2/389—Tibial components
-
- 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
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30009—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in fibre orientations
-
- A—HUMAN NECESSITIES
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- A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
- A61F2002/30032—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in absorbability or resorbability, i.e. in absorption or resorption time
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- A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
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- A—HUMAN NECESSITIES
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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
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Abstract
(57)【要約】
連結すべき骨(8,9)の間に人工器官として移植することを目的とする優れた特性、成形柔軟性及び操作性を有する円筒状組織性孔質ジョイントスペーサーを提供する。このジョイントスペーサーは生体吸収性ファイバーを含んで成り、且つ編成、製織、不織又はその他の技術により作られた布帛ストリップ(1)から形成されうる。この布帛(1)は、当該布帛(1)から形成する人工器官の意図する用途に依存して典型的には細く(例えば1〜10mm幅)且つ薄い(例えば厚さ0.1〜1.0mm)。このジョイントスペーサーは前記布帛(1)を巻いて円筒状本体(2)にし;そしてこの布帛(1)の自由端をそのようにして成形した円筒状本体(2)の表面に取付けることで作られる。このジョイントスペーサーはそれを連結すべき骨(15,16)の間に固定するための1又は複数の固定部(14’,14”)と一緒に移植されうる。
Description
【発明の詳細な説明】
人工関節
本発明は生物学的に活性な人工関節及びその製造方法に関連する。
負傷した関節、特に手及び足における小骨間を接続する関節を代替するための
非生物分解性プラスチックから成る合成弾性関節インプラントを利用することが
当業界において知られている。典型的な生体安定性弾性人工関節は、連結すべき
骨の間に配置するスペーサー部、及び連結すべき骨に固定される2つの長い固定
部から成る。かかる人工関節は例えばDow Corning,S.A.,Valbourne Cedex,F
ranceから商標名Silastic(登録商標)のもとで入手できる。Si1a
しかしながら、生体安定性ポリマー、ポリマー混合物及びエラストマーから成
る人工関節の利用は患者に問題を生じせしめうる。生体安定人工関節に関わるか
かる問題の一つは手術を受けた肢が手術の後に一定の負担にしか耐えることがで
きない点にある。例えば、
けた手は5kg以上の力の負担に耐えることができず、そして過剰な負担は人工関
節を構成するインプラントの破壊又は磨耗を招くことがある。かかる生体安定人
工関節の別の問題は磨耗、疲労及び/又は腐蝕により人工関節からばらばらな粒
子が遊離することにあり、かかる粒子は慢性の炎症反応、例えば滑膜炎、及び/
又は骨における骨学的変化を及ぼしうる。更に、この炎症反応は往々にして人工
関節の除去を要する程度に至る関節における腫脹及び疼痛を及ぼしうる。
本願の譲受人に譲渡されたPCT公開WO 96/41596にはスペーサー部並びに連結
すべき骨に固定されている近位及び遠位固定部分を含んで成る生物分解性人工関
節が記載されている。WO 96/41596に係る人工関節は手、手首又は足の領域の中
に、負傷関節を全体的に又は部分的に代替するように移植することができる。WO
96/41596の人工関節のスペーサー部は連結すべき骨を互いから所望の距離に保
つ。この人工関節は骨に、近位及び遠位固定部のそれぞれを連結すべき2本の骨
の中に固定させることによって固定する。WO 96/41596の人工関節の固定部の強
さ及び延性値は手術を受けた関節が移植のすぐ後に曲げることができるようにす
るよう選定される。
WO 96/41596の人工関節のスペーサー部はこの人工関節の機能にとって重要で
ある。所望の孔質性(典型的には50μm〜1000μmの孔径)を得るため、WO 96
/41596のスペーサー部は好ましくは繊維状の三次元な部分的に孔質な生物分解
性ファイバー構造から成り、そのファイバーは典型的には1〜300μmの厚みを
有する。かかるスペーサー部を作るため、生物分解性ファイバーを製織もしくは
編成するか、又は不織布にし、次いで三次元の枕様孔質構造へと折りたたむ又は
巻いてよい。WO 96/41596のスペーサー部はまた:(i)三次元製織(weaving)
、編成(knitting)又は加撚(twisting)技術を利用して連続ファイバーブラン
クから(ここで所望の長さのこの連続ファイバーブランクを各スペーサー部のた
めに切断する);(ii)所望の長さに切り、そして生物分解性結合ブランクを利
用して束ねた生物分解性ファイバーから;又は(iii)中に開放孔質性を供する
ように処理する生物分解性連続ポリマーブランクから;も作ることができる。
WO 96/41596のスペーサー部の形状は人工関節により連結する
骨の間のすき間に対応するのが好ましい。従って、このスペーサー部は枕状、円
筒状、楕円状、(平たくした)球状、立方体もしくは長方形プリズム、又はその
他の三次元構造であって、連結すべき骨の間のスペーサー部のために構築された
空間を可能な限り埋めるような構造をとってよい。WO 96/41596のスペーサー部
は好都合には弾性であり、そしてそれは周囲組織の機械的刺激を及ぼすことので
きない任意の鋭利及び/又は硬質な縁又は角を含まないのがよい。
本発明に従って、円筒繊維状の孔質ジョイントスペーサーが提供され、それは
優れた特性、成形柔軟性及び操作性を有し、連結し合う骨の間に人工器官として
移植されることを目的とする。本発明のジョイントスペーサーは生体吸収性ファ
イバーを含んで成り、そして不織布の編成、製織又はその他の技術により作られ
る布帛ストリップから成形できうる。この布帛は典型的には、その布帛から成形
する人工器官の意図する用途に依存して比較的細く(例えば幅1〜10mm)、且つ
薄い(例えば厚さ1〜1.0mm)。本発明のもとで、このジョイントスペーサーは
当該布帛を巻いて円筒状本体にし、そしてその布帛の自由端をこのようにして成
形した円筒状本体の表面に固定することによって作る。本発明のジョイントスペ
ーサーは連結すべき骨の間にジョイントスペーサーを固定するようl又は複数の
固定部と一緒に移植されうる。
以下は添付図面を参照しながらの本発明のいくつかの特定の態様の説明である
。ここで:
図1は円筒状本体を形成するための布帛の巻状化を示し;
図2は縫製による布帛の先端の円筒状本体の表面に対する固定を示し;
図3は接着による布帛の先端の円筒状本体の表面に対する固定を
示し;
図4は本発明において利用できる様々な布帛を示し、ここで各々のかかる布帛
は様々な厚み及び/又は締まりのファイバーを有する;
図5は本発明において利用できる布帛を示し、ここでこの布帛はカールした又
はらせん状に屈曲したファイバーから成る;
図6は円筒状本体を示し、ここでこの円筒状本体はその中心において薄く、そ
してその外縁において厚くなっている;
図7は円筒状本体を形成するよう接着フィルムを用いた布帛の巻状化を示し;
図8は孔質円筒状本体を示し、ここでこの円筒状本体は縦方向の垂直孔を有し
;
図9A〜9Cは骨と円筒状本体との様々な配置を示し;
図10A〜10Cは円筒状本体及び固定ピンを含んで成る人工関節を示し;
図11A及び11Bは脛骨の近位端に配置する滑液軟骨表面上の部分人工器官とし
ての円筒状本体を示し;
図12は2個の円筒状本体及び2個の固定部を含んで成る人工器官を示し、ここ
でその2個の円筒状本体の間に腔が設けられてあり;
図13は2本の骨の間に移植する円筒状本体を示し、ここでこの円筒状本体は滑
液腔を擬態する環状の裂け目を含む。
本発明は改善された特性及び機能的特徴を有する移植可能な円筒繊維状人工器
官並びにその製法に関連する。
図1に示す通り、本発明のジョイントスペーサーは円筒状本体2を形成するよ
うに巻かれた繊維布帛1から製造される。このようにして成形した円筒状本体の
サイズは図1に示すその直径「D」及びその厚み「t」を特徴とする。図1,2
及び3に従うと、布帛3の
自由端は円筒状本体の表面に、例えば生体吸収性縫合糸4で縫製することにより
、又は生体吸収性ポリマーメルトもしくは溶液5により接着することにより固定
する。
布帛を巻くことによる円筒状本体2の製造は従来技術と比べていくつかの利点
を供する。円筒状本体2の直径Dはこの円筒状本体を形成するのに用いる布帛の
長さを変えることにより容易且つ簡単に変えることができる。更に、外科医は手
術室で必要なら円筒状本体の固定部(4又は5)を開き、布帛を所望の点にまで
ほどき、ほどけた部分を切り取り、そしてその布帛の新たな自由端を円筒状本体
に取り付けることにより簡単にDを小さくすることができる。同様に、円筒状本
体2の厚みtは図1に示すように様々な幅t’を有する布帛を選択することによ
り簡単に変更できる。
円筒状本体2の孔質度も様々な方法で好適に変えることができる。例えば、布
帛Iの孔質度は布帛の織物構造を変えることにより調節できる。布帛1の孔径及
び分布もその布帛を作るのに用いたファイバーの厚みを変えることにより、即ち
、その布帛に細い(例えば0.1〜10μm)のファイバー、厚めのファイバー(例
えば10〜500μm)又はそれらの混合を利用することにより調節することができ
る。布帛1(及び円筒状本体2)の孔質度は布帛を作るのに用いたファイバーの
分布及び/又は直径を変えることによっても調節できる。図4に模式的に示して
いるのは様々な分布及び/又は直径のファイバーを有する本発明において利用す
るためのいくつかの典型的なファイバーの例である。図4に示されているものの
他に、布帛において数多くのその他のファイバー厚み及び分布が本発明のもとで
可能である。ファイバーの厚み及び/もしくは分布及び/もしくは配向を変える
ことにより、並びに/又はかかるファイバーから布帛を作るための編成、製織又
は不織技術を変えることにより、ジョイ
ントスペーサーは耐荷重特性、磨耗特性及び組織成長特性に関連する様々な仕様
に従って調製できる。
図5に示すように、これらのファイバーは布帛1の製造に入る前にカール又は
らせん式に加撚させてよい。かかる布帛を巻くと、得られる円筒状本体2は極め
て孔質及び弾性となる。この円筒状本体2の孔質度は巻状化操作の際に布帛にか
かる張力を調節することによっても変えることができる。もし弱めの張力を利用
すると、巻状にした円筒状本体はゆるく、且つ柔く、そしてこの円筒状本体の厚
みtは布帛の幅tとほぼ同じとなりうる。もし強い張力を巻状化操作の際に利用
すると、布帛はよりきつくなり、硬く、そして孔質度は小さくなり、その結果と
しての円筒状本体の厚みtは布帛の幅t’よりも小さくなりうる。更に、巻状化
操作の際の布帛に対する張力を変えることにより、様々な厚み及び孔質度を有す
る円筒状本体が出来上がる。例えば、巻き付け操作の当初では強い張力を利用し
、そしてその張力を巻き付けの際に暫進的に弱めると、図6に示すように中央区
画が高密度となり、且つ厚みの薄い円筒状本体が出来上がる。
本発明のジョイントスペーサーを作るために用いる布帛は生物分解性ポリマー
、コポリマー、ポリマー混合物もしくは組成物のファイバーを用いることにより
、又は様々な生物分解性ポリマー物質を組合せることにより製造できる。様々な
生物分解性ポリマーのファイバーを組合せて本発明に係る布帛を作ると、組織の
中で不均一な状態で分解するであろうジョイントスペーサーが構築でき、なぜな
ら布帛を構成するこの様々なファイバーは組織において異なる分解速度を有しう
るからである。他方、組織におけるジョイントスペーサーの不均一な分解は布帛
に、その布帛を作るのに用いた1又は複数種のポリマーとは異なる組織内分解速
度を有する生物分解性材料
をコーティングすることにより本発明に従って達成されうる。
医療技術及び特許文献において、本発明に係る人工関節を作るための原材料と
して適切な多数の生物分解性ポリマーが特定されている。これらには、例えば生
物分解性脂肪族ポリエステル(例えば、Vainionpaa,S Rokkanen,P,and Torma
la,PのProgr.Polym .Sci.14(1989)pp.679-716;米国特許第4,743,257、5,
084,051、4,968,317号;EPO出願第0,423,155号;及びPCT出願PCT/FI93/00014
参照のこと);並びにポリエステルアミド、ポリオルトエステル、ポリアンヒド
リド及びポリホスファザン(例えば、C.T.Laurensinら、J .Bigmed Matter.R es.27
(1993),pp.963-973参照のこと)が挙げられる。
ジョイントの腔の中に配置すると、本発明のジョイントスペーサーは接織によ
り比較的迅速に被覆及び/又は充填される。その生物分解過程の間、ジョイント
スペーサーは生物学的繊維組織により置換される。その結果、新たな生物弾性繊
維組織関節が得られ、それは周囲の筋肉による接続骨の動きを可能にする。この
ジョイントスペーサーの生物分解過程の間に新たな関節が形成されると、患者の
系に慢性的に有害な外来粒子が、いわゆる生体安定人工関節の場合のように放出
されることがない。かくして、本発明のジョイントスペーサーは、生体安定人工
関節を用いたときに考えられるばらばらな外来粒子により生ずるかかる慢性合併
症の危険性を完全に排除する。
移植した後のジョイントスペーサー内での組織成長を可能にするため、本発明
の円筒状本体は好都合には多孔質であり、その孔径は例えば50μm〜1,000μm
の間で様々である。この円筒状本体の孔径は上記の通り、人工器官の所望の機械
的強度及び接続すべき骨の間の距離に従って変動しうる。
本発明の一の態様において、この円筒状本体の巻状布帛層は、布帛を巻く前に
その布帛よりも低い融点を有する別の生体吸収性ポリマーでその布帛の表面をコ
ーティングすることにより、又は図7に示すように布帛と一緒に巻かれた接着生
体吸収性フィルム6を利用することにより互いと接着させ合う。この布帛の接着
は別の生体吸収性ポリマー溶液を用いて達成されることもできる。熱及び/又は
圧力を利用することにより、布帛コーティング又は接着生体吸収性フィルムを柔
軟及び/又は溶融させて巻状布帛を結合させ、そして中実円筒状本体を形成する
ことができる。特に上記の接着生体吸収性フィルムを用いるとき、図8に模式的
に示すように円筒状本体の平坦な表面に対して垂直方向で配向した孔及び/又は
チャンネル7を設けることが可能である。かかる配向した孔及び/又はチャンネ
ルはガイド式組織再生(即ち、特定の方向に向けられた組織成長)を所望する場
合に好都合である。
本発明のもとでは、円筒状本体の剛性、柔軟性、表面質及び孔質度はこの円筒
状本体を高温で(典型的には温度T>Tgで:ここでTgは円筒状本体のファイバー
成分のガラス転移温度である)、最適には適当なモルド内で、且つ機械的圧力の
もとでアニーリングすることによりコントロールできうる。アニーリング及び同
時機械的加圧は円筒状本体を剛性にし、そしてその処理をモルド内で行うと、円
筒状本体の形状は恒久式に変化されることができ、例えば円筒状本体の環状幾何
形態は平たくなりうるか、又はその平坦な表面をカーブさせることができる。
本発明のジョイントスペーサーは驚くべきことに、接続すべき骨の片方又は両
方がジョイント面除去されていようとなかろうと、移植後に良好に機能する。図
9Aは2本の指又は足指のジョイント面の断面を示し、ここで双方の骨のジョイ
ント面は除去されており、
そしてそのジョイント空間は平らな面10’及び10”を有する円筒状本体10で満た
されている。図9Bはジョイント面が一方の骨11のみから除去され、そして接続
する他方の骨12からは除去されていない態様を示す。この状況に適合するため、
移植した円筒状本体11の片面11’は凹となっていてよく、そして他方の面11”は
平らとなっていてよい。図9Cは円筒状本体12の両面12’及び12”が接続すべき
2本の骨の凹型接続面に嵌合するよう凸となっている態様を示す。
本発明のジョイントスペーサー(円筒状本体)は、WO 96/41596におけるスペ
ーサー部及び固定部に関してその中に記載されているように、接続すべきジョイ
ントスペーサーを固定するように配置された様々なタイプの固定部(例えば1又
は複数個のピン、スクリュー、ボルト又はロッドを単独で又は組合せて)との組
合せにおいて利用することもできる。本発明に係る人工関節の固定部は、その固
定部及びジョイントスペーサーが一緒になってフレキシブル人工関節を形成する
ようにそれらが固定且つ一体化した物を形成するようジョイントスペーサーに連
結されていることを特徴とする。固定部を介し、このジョイントスペーサーは連
結する骨の間に保たれ、それにおいては筋力を介してその固定部は互いと連結し
合っている骨を屈曲させることを可能にする。
本発明に従うと、この固定部は溶融成形法、例えば射出成形もしくは押出を利
用することにより生物分解性ポリマー、ポリマー混合物もしくは組成物から製造
されうるか、又はそれらは所望の形態となるためにポリマーブランクから機械的
に成形されたものであってよい。自己補強型生物分解性組成物が本発明に係る固
定部を作るうえでの原材料として利用するために特に好都合な組成物である。か
かる組成物は当業界において公知であり、そして公開物、例えば米国特許第4,74
3,257号及び出願WO 99/05312に記載されている。
その他の生物分解性組成物も本発明に係る固定部を補強するために用いてよく、
ここでこの固定部はファイバー、カットファイバー、フラメント又はそれらから
構築された構造体、例えば編組、加工糸(thread)、糸、不織構造体、布、ニッ
ト等により補強されており、その補強も生物分解性ポリマー、コポリマー又はポ
リマー混合物から成る。固定部のためのかかる補強を作るための生物分解性組成
物は当業界において公知であり、そして数多くのかかるポリマーが本明細書にお
いて引用する文献の中に特定されている。本発明の固定部は生物分解性セラミッ
ク材料、例えばバイオガラス又はリン酸カルシウムから成るファイバーで補強さ
れていてもよい(例えば、
.14(89)pp.679-716を参照のこと)。
生物分解性有機及び/又は無機ファイバー又はそれから構築された構造体によ
り補強された本発明に係る固定部はプラスチック技術において公知の様々な方法
、例えば補強化構造を生体吸収性ポリマー、コポリマー又はポリマー混合物(マ
トリックス)を介して少なくとも部分的に互いと結合させることにより製造でき
、その製造における条件はマトリックスが溶液内にあり(又は溶融形態にあり)
、且つ十分に均質な組成物がそのマトリックス及び補強剤から形成されるような
ものとする。所望するなら、本発明の固定部はジョイントスペーサーと同じよう
に孔質であってよく、ここで組織成長は周囲組織から固定部の開放孔の中で起こ
り、その結果この固定部はその位置において直ちに固定される。
本発明のインプラント(ジョイントスペーサー及び固定部)は材料の加工性を
促進する(例えば安定化剤、酸化防止剤又は柔軟剤)又はその特性を改変する(
例えば柔軟剤又は粉末状のセラミック化学品又は生体安定性ファイバー、例えば
カーボンファイバー)、又
はその用途を促進する(例えば着色剤)ための様々な添加剤も含みうる。本発明
の固定部は患者自身の繊維組織、例えば鍵又は靭帯組織から、接続すべき一方の
骨から他方のかかる骨に至るまでの十分に長い鍵又は靱帯部をジョイントスペー
サーが骨の間に配され、そして腱又は靱帯がそのスペーサー部に侵入するように
操作することにより、構築することもできうる。
本発明の一の好都合な態様に従うと、このジョイントスペーサー及び/又は固
定部は1又は複数種の生物活性剤、例えば抗生物質、化学療法剤、創傷治癒促進
剤及び軟骨コラーゲン形成誘導剤、成長ホルモン、抗凝固剤(例えばヘパリン)
、等を含む。このタイプの生物活性媒体は臨床学的用途において極めて好都合で
あり、なぜならその機械的効果に加えて、こらは生化学的効果(例えば繊維及び
/又は軟骨組織の成長の促進)、医療、及びヒト組織におけるその他の効果を有
するからである。
本発明の固定部は硬質又は柔軟構造を有しうる。硬質固定部は典型的にはロッ
ド、バー、スクリュー又はピンを含んで成り、それはそのステムにおいてジョイ
ントスペーサーに接続されており、そしてその地点は連結すべき骨の内側にある
。このタイプの固定部の表面上の輪郭(例えばねじれ、様々な目盛又は段階)は
骨の内側に設けられた穴への固定部の固定を促進する。弾性固定部は例えばこの
ジョイントスペーサーに装着された又はその一部である布(「ベール」)を含ん
で成ってよく、そしてそれは連結すべき骨の表面上に固定されている(小型の吸
収性ピン又は縫合糸により)。かかる弾性固定部は更に、ジョイントスペーサー
を連結すべきジョイントスペーサーに固定するために用いる1又は複数の吸収性
縫合糸ループを含んで成ってもよい。
図10は小骨(例えば手及び足の骨)を互いに連結するために用い
る本発明に係る人工関節の一の適用の模式図を示す。
図10Aは側面、即ち関節の屈曲方向に対して平行な位置から見た骨15及び16の
模式図であり、ここで人工関節の施された関節はまっすぐである。
図10Bは側面、即ち関節の屈曲方向に対して平行な位置から見た骨15及び16の
模式図であり、ここで人工関節の施された関節は曲がっている。
図10Cは上面、即ち、関節の屈曲方向に対して垂直な位置から見た骨15及び16
の模式図であり、ここで人工関節の施された関節はまっすぐである。
図10に示す通り、棒状固定部14は円筒状本体13を貫通し、そしてこの固定部の
末端14’及び14”は骨15及び16の内側に位置する。本発明は当業界において公知
であり、そして例えばWO 96/41596のFig.1〜5に示す数多くのその他の形態の
固定部及びジョイントスペーサー(スペーサー部)の中に移植されうる。
更に図11Aに示すように、本発明の円筒状本体(ジョイントスペーサー)は滑
液関節表面17上の部分人工器官として利用できる。図11Bにおける断面a−aで
わかる通り、平らな円筒状本体18は骨20の表面上の軟骨表面17の中の腔19の中に
配置される。この孔質繊維状円筒状本体18は、この円筒状本体の生体吸収及び新
たな成長組織によるその置換の際の腔19に至る新たな軟骨の形成を誘導する。こ
の過程の結果、新たな軟骨表面が負傷を負った腔19の中で構築される。一の好都
合な態様において、この円筒状本体18に、移植の前に軟骨細胞又はある種の似た
ようなタイプの細胞を載せておく。組織工学において複数種のタイプの細胞を患
者から採取し、細胞培養条件下で増殖させ、孔質生体吸収性ジョイントスペーサ
ー(円筒状本体)の中に入れ、そして患者に移植して組織の外傷又は欠陥の治癒
を促進させることが知られている。
本発明の別の好都合な態様において、当該人工器官は2個の円筒状本体を含ん
で成り、これはジョイント腔の中で互いと平行に配置されていてよい。かかる形
態において、これらの円筒状本体の間に滑液関節腔をシミュレーションする垂直
腔が残される。図12に示すように、円筒状本体21及び22は爪様固定部23及び24に
より骨25及び26に固定され、かくして滑液腔様空間27が円筒状本体21及び22の間
に残る。患者がかかる移植の後に関節を動かすと、この円筒状本体21及び22は相
対的に滑り運動し、そして滑液腔様空間は成長中の組織関節の内側に残り続けう
る。
図12に示す本発明の別の好都合な態様において、腔27の壁を形成している円筒
状本体21及び22の接触面には硝子質の軟骨細胞及び/又は成長因子もしくはその
他の生物活性物質(又はその他の成長因子を遊離する生体吸収ポリマー)がコー
ティングされ、硝子質軟骨の成長又は成長する関節の腔表面上の軟骨層の形成が
促進されていてよい。更に、図12に示すように、骨25及び26と接触している円筒
状本体21及び22の表面に骨形態発生タンパク質(BMP)又はその他のBMP遊離性生体
吸収ポリマーがコーティングされ、各円筒状本体21及び22の対応の骨への骨化が
促進されていてよい。
本発明に係る滑液腔をシミュレートする別の態様を図13に示す。この図に示す
ように、平らな穴又は環状の裂け目が円筒状本体19の内側に配置されている。
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フロントページの続き
(72)発明者 パーシマー,センヤ
フィンランド国,エフイーエン―33720
タンペレ,リンドフォルシンカトゥ 6
セー 42
(72)発明者 リート,マティ
フィンランド国,エフイーエン―33700
タンペレ,パルバニーメンカトゥ 7 エ
フ 25
Claims (1)
- 【特許請求の範囲】 1.連結すべき骨の間に移植するための人工器官であって、生体吸収性布帛を 円筒状本体へと巻くことによって作られた孔質ジョイントスペーサーを含んで成 る人工器官。 2.前記ジョイントスペーサーの孔が約50μm〜1,000μmであることを更な る特徴とする、請求項1記載の人工器官。 3.前記孔質ジョイントスペーサーが、前記生体吸収性布帛と結合する生体吸 収性フィルムを円筒状本体へと巻くことによって作られることを更なる特徴とす る、請求項1又は2記載の人工器官。 4.前記生体吸収性布帛が組織内で異なる分解速度を有する少なくとも2種類 の化合物を含んで成ることを更なる特徴とする、請求項1〜3のいずれか1項記 載の人工器官。 5.前記生体吸収性布帛が当該生体吸収性布帛とは異なる組織内での分解速度 を有する材料でコーティングされていることを更なる特徴とする、請求項4記載 の人工器官。 6.前記生体吸収性布帛が組織内で異なる分解速度を有する2種類以上の生物 分解性ファイバーから作られたことを更なる特徴とする、請求項4又は5記載の 人工器官。 7.前記布帛が約1〜300μmの厚みを有する生物分解性ファイバーから作ら れたことを更なる特徴とする、請求項1〜6のいずれか1項記載の人工器官。 8.前記円筒状本体が当該本体を骨に固定するための固定具を有することを更 なる特徴とする、請求項1〜7のいずれか1項記載の人工器官。 9.前記固定部が少なくとも一本のピン、スクリュー、ボルト又はロッドを含 んで成ることを更なる特徴とする、請求項8記載の人工器官。 10.前記固定部が少なくとも一のネジ、編組又は布を含んで成ることを更なる 特徴とする、請求項8記載の人工器官。 11.前記固定部が前記円筒状本体の一部を構成していることを更なる特徴とす る、請求項8記載の人工器官。 12.前記固定部が生体吸収性縫合糸を含んで成ることを更なる特徴とする、請 求項8記載の人工器官。 13.前記固定部が組織を含んで成ることを更なる特徴とする、請求項8記載の 人工器官。 14.連結すべき骨の間に移植するための人工器官であって、生体吸収性布帛を 円筒状本体へと巻くことにより作られた第一孔質ジョイントスペーサー及び生体 吸収性布帛を円筒状本体へと巻くことによって作られた第二孔質ジョイントスペ ーサーを含んで成り、ここで当該人工器官を患者に移植すると、前記第一孔質ジ ョイントスペーサー及び前記第二孔質ジョイントスペーサーは腔を形成する形状 をとる、人工器官。 15.連結すべき骨の間に移植するための人工器官を形成するための方法であっ て: a)生体吸収性布帛を所望の長さに切り; b)この生体吸収性布帛を円筒状本体へと巻きそして c)この円筒状本体の自由端を当該円筒状本体に取り付ける; 工程を含んで成る方法。
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US08/873,174 US6113640A (en) | 1997-06-11 | 1997-06-11 | Reconstructive bioabsorbable joint prosthesis |
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JP2002503123A true JP2002503123A (ja) | 2002-01-29 |
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JP50140599A Pending JP2002503123A (ja) | 1997-06-11 | 1998-05-22 | 人工関節 |
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US (1) | US6113640A (ja) |
EP (2) | EP1356794A3 (ja) |
JP (1) | JP2002503123A (ja) |
AT (1) | ATE274874T1 (ja) |
AU (1) | AU7914998A (ja) |
CA (1) | CA2290787A1 (ja) |
DE (1) | DE69826000T2 (ja) |
WO (1) | WO1998056317A1 (ja) |
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DE59108588D1 (de) * | 1991-08-07 | 1997-04-10 | Oscobal Ag | Endoprothese mit einem Metalldrahtwerk |
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ATE241327T1 (de) * | 1993-09-14 | 2003-06-15 | Lanny L Johnson | Biologischer bandersatz |
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FI101129B (sv) * | 1995-01-13 | 1998-04-30 | Vivoxid Oy | Nya bioaktiva glas och deras användning |
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US5534033A (en) * | 1995-06-05 | 1996-07-09 | Carbomedics, Inc. | Orthopedic prosthetic implants with pyrolytic carbon or ceramic articulating surfaces |
FI101933B (fi) * | 1995-06-13 | 1998-09-30 | Biocon Oy | Nivelproteesi |
EP0773008B2 (de) * | 1995-11-08 | 2009-05-20 | Zimmer GmbH | Zwischenwirbelprothese |
US5683466A (en) * | 1996-03-26 | 1997-11-04 | Vitale; Glenn C. | Joint surface replacement system |
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-
1997
- 1997-06-11 US US08/873,174 patent/US6113640A/en not_active Expired - Fee Related
-
1998
- 1998-05-22 AT AT98929363T patent/ATE274874T1/de not_active IP Right Cessation
- 1998-05-22 DE DE69826000T patent/DE69826000T2/de not_active Expired - Fee Related
- 1998-05-22 CA CA002290787A patent/CA2290787A1/en not_active Abandoned
- 1998-05-22 AU AU79149/98A patent/AU7914998A/en not_active Abandoned
- 1998-05-22 EP EP03077172A patent/EP1356794A3/en not_active Withdrawn
- 1998-05-22 JP JP50140599A patent/JP2002503123A/ja active Pending
- 1998-05-22 WO PCT/EP1998/003030 patent/WO1998056317A1/en active IP Right Grant
- 1998-05-22 EP EP98929363A patent/EP0988001B1/en not_active Expired - Lifetime
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2009502334A (ja) * | 2005-07-29 | 2009-01-29 | ゴア エンタープライズ ホールディングス,インコーポレイティド | 多孔質自己凝集ウェブ材料の製造方法 |
Also Published As
Publication number | Publication date |
---|---|
EP0988001A1 (en) | 2000-03-29 |
EP1356794A2 (en) | 2003-10-29 |
ATE274874T1 (de) | 2004-09-15 |
DE69826000T2 (de) | 2005-09-08 |
WO1998056317A1 (en) | 1998-12-17 |
US6113640A (en) | 2000-09-05 |
CA2290787A1 (en) | 1998-12-17 |
EP0988001B1 (en) | 2004-09-01 |
DE69826000D1 (de) | 2004-10-07 |
AU7914998A (en) | 1998-12-30 |
EP1356794A3 (en) | 2003-11-05 |
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