JP6017425B2 - ヒトまたは動物の関節を修復するための装置 - Google Patents
ヒトまたは動物の関節を修復するための装置 Download PDFInfo
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- JP6017425B2 JP6017425B2 JP2013528488A JP2013528488A JP6017425B2 JP 6017425 B2 JP6017425 B2 JP 6017425B2 JP 2013528488 A JP2013528488 A JP 2013528488A JP 2013528488 A JP2013528488 A JP 2013528488A JP 6017425 B2 JP6017425 B2 JP 6017425B2
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- Prior art keywords
- joint
- joints
- connector part
- thermoplastic properties
- bone tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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
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Description
本発明は医療技術の分野に属しており、ヒトまたは動物の関節、特にヒトの面関節などの小さな滑膜関節、ヒトの手や足の関節(指関節およびつま先関節を含む)、仙腸関節、胸鎖関節、胸肋関節または肋椎関節だけでなく、軟骨性連結、特に椎間関節をも修復するための方法および装置に向けられる。「関節を修復する」という表現は本明細書において、関節に装置を挿入して装置を関節の両関節面に締結することによる両関節面に関する手術という意味で使用され、手術後、関節は少なくとも制限された関節接合が可能になり、すなわち当該修復はいわゆる関節癒合(手術後の関節接合能力なし)ではなく、たとえば関節面再建(ほぼ完全な関節接合能力を維持または回復)である。
米国特許第5,571,191号(Fitz)はヒトの面関節の面再建のための方法および装置を開示している。当該装置は、連続する2つの手術工程において関節の関節突起に締結される2つの独立したキャップ状の部品を含み、当該部品の各々が人工関節面を構成している。国際公開第WO2008/034276号も、このような面再建のための方法および装置を開示している。上記の両方の場合において提案されているような手術については、治療すべき関節の関節面を、当該関節を脱臼させるか外すことによって、または関節包および関連の靭帯を大きく切除することによって、アクセスできるようにする必要がある。
本発明の目的は、ヒトまたは動物の患者の関節、特に、たとえばヒトの面関節などの小さな滑膜関節、またはたとえばヒトの椎間関節などの軟骨性連結を修復するための方法および装置を提供することである。修復した関節は手術後に制限された関節接合から完全な関節接合が可能になる。関節の両関節面を同時に治療する。当該修復は、適切に準備した関節面同士の間に装置を挿入すること、および、熱可塑性特性を有し振動エネルギの印加によってインシチュー液化される材料を用いて、1つの手術工程のみで装置部分をこれら表面のいずれか一方に固定することを含む。
最新技術に関して上記で述べたように、装置を硬組織(ほとんどの場合骨組織であるが適切な骨置換材料も含む)内にアンカー固定するための、振動エネルギを用いた熱可塑性特性を有する材料の標的インシチュー液化は、当該装置が、振動工具と接触している近面から所望の液化の部位まで、すなわち振動装置またはその一部と対の要素(骨組織もしくはさらなる装置部分)との間の界面まで、できる限り少ない損失で振動エネルギを伝達可能であるように設計されれば、手術部位の組織に過度の熱負荷をかけずに達成可能である。このような効率的なエネルギ伝達は、装置と硬組織との間の界面における所望の液化の場合は、装置を単一の剛性振動器として設計し、装置全体を振動させることによって達成され、2つの装置部分同士の間の所望の液化の場合は、装置を2つの剛性部分を有するように設計し、一方の剛性部分を振動させて他方の部分は振動させないことによって達成される。この要件は、2つの装置部分が互いに関節接合可能であることを必要とする、すなわち2つの装置部分同士の間の剛性接続を禁止する、治療後の関節の少なくとも制限された関節接合の要件とは対照的である。
図1〜図5は、本発明に係る装置の第1の好ましいグループの実施例の例を示す。当該装置は、2つの関節部1および2と、弾性界面部3と、スプレッダの形態のコネクタ部4とを含む。図1は完成した装置の三次元表現であり、装置を移植するために用いられる振動工具5の遠端をさらに示す。図2、図3および図4は、完成した装置の断面である(図2は移植方向IDに垂直な切断線II−II、図2および図3は移植方向IDと平行な切断線III−IIIおよびIV−IVであり、切断線は図1に示す)。図5はコネクタ部のみの三次元表現である。
・界面部3は、移植方向と平行に延在する中心線の両側で異なる厚みを有し、すなわち2つの関節部1および2は互いに角度が付けられる。
・熱可塑性特性を有する材料からなる2つまたは3つ以上の***部10を含む代わりに、各関節部1および2は、熱可塑性特性を有する材料からなる完全なまたは部分的なコーティングを含み、関節の関節面に溝は設けられない。
・コネクタ部4は装置の移植直後に取外されず、第2の外科手術において取外され、取外工具は、振動工具5が移植のためにコネクタ部4に接続されるのと同じようにコネクタ部4に接続され得る。
Claims (23)
- ヒトまたは動物の滑膜関節を治療するための装置であって、前記関節は2つの関節面を含み、前記装置は、
少なくとも互いに制限された関節接合および平行移動が可能であり、熱可塑性特性を有する材料および振動エネルギを用いて前記関節面の各々に1つずつ固定されるように設けられた2つの関節部(1および2)を備え、熱可塑性特性を有する前記材料は、各関節部(1および2)の外側に配置され、前記装置はさらに、
前記2つの関節部(1および2)の間または周りに着脱可能に配置され、前記装置が少なくとも移植の間は一片を構成するように前記2つの関節部(1および2)を接続して剛性を有する非関節接合要素を形成する、一時的なコネクタ部(4)を備える、装置。 - 前記関節部(1および2)は、キャリア板(11)の外面から突出する***部(10);前記キャリア板(11)の前記外面のコーティング;および前記キャリア板の外側の溝に配置される、または前記キャリア板の上もしくは内部の穿孔されたシースもしくはトンネル内に配置されるピン;の少なくとも1つに、熱可塑性特性を有する前記材料を含む、請求項1に記載の装置。
- 前記関節部の全体が、熱可塑性特性を有する前記材料からなる、請求項1に記載の装置。
- ヒトまたは動物の滑膜関節を治療するための装置であって、前記関節は2つの関節面を含み、前記装置は、
少なくとも互いに制限された関節接合および平行移動が可能であり、熱可塑性特性を有する材料および振動エネルギを用いて前記関節面の各々に1つずつ固定されるように設けられ、穿孔を含むシース(41)もしくはトンネル、またはキャリア板(11)の外側の溝を含む2つの関節部(1および2)と、
熱可塑性特性を有する前記材料の複数のピンであって、前記シースまたは前記トンネルまたは前記溝に押込まれ、熱可塑性特性を有する材料の液化のために振動させられて、隣接する骨組織に流れ込む複数のピンと、
一時的なコネクタ部(4)は、前記2つの関節部(1および2)の間または周りに着脱可能に配置され、前記2つの関節部(1および2)を接続して剛性を有する非関節接合要素を形成する、装置。 - 前記関節部(1および2)の内側同士の間に配置された界面部(3)をさらに備える、請求項1〜請求項4のいずれか1項に記載の装置。
- 前記界面部(3)は弾性を有し、前記2つの関節部(1および2)の前記内側の各々に固定され、前記コネクタ部(4)は、前記関節部(1および2)の前記内側同士の間に締付けられるか締付け可能であり、かつ前記界面部の弾性によって締付けられた位置で保持されるスプレッダである、請求項5に記載の装置。
- 前記界面部(3)は弾性を有するか剛性を有するか存在せず、前記一時的なコネクタ部(4)は、前記2つの関節部(1および2)を互いに締付けることが可能なクランプである、請求項5に記載の装置。
- 前記界面部(3)は、前記関節部(1および2)の前記内側に取付られずに配置される、請求項7に記載の装置。
- 前記一時的なコネクタ部(4)は剛性を有し、前記2つの関節部(1および2)同士の間に配置され、前記関節部(1および2)の各々に剛性的に取付けられ、前記一時的なコネクタ部(4)は少なくとも部分的に生物学的再吸収可能または生物学的分解可能な材料からなる、請求項1または請求項4に記載の装置。
- 前記界面部(3)は生物学的再吸収可能または生物学的分解可能な材料からなる、請求項5〜8のいずれか一項に記載の装置。
- 非ヒト動物患者の滑膜関節を治療するための方法であって、前記関節は2つの関節面を含み、前記方法は、
請求項1に記載の装置を提供するステップを備え、熱可塑性特性を有する前記材料は前記関節部(1および2)に組込まれ、前記方法はさらに、
軟骨下骨組織を少なくとも部分的に露出するように前記関節の前記関節面を準備するステップと、
準備した前記関節面同士の間に前記装置を押込み、同時に、熱可塑性特性を有する前記材料の少なくとも一部を液化するのに十分な時間だけ前記装置を振動させ、前記材料を露出した前記軟骨下骨組織に浸透させるステップと、
液化した前記材料を凝固させて、前記装置と露出した前記軟骨下骨組織との間に形状嵌合接続を構成するステップと、
前記関節の少なくとも制限された関節接合および平行移動を可能にするように、前記一時的なコネクタ部(4)を取外すステップとを備える、方法。 - 前記関節を固定するステップと、前記関節を固定した状態から解放するステップとをさらに備え、前記固定するステップは、前記押込むステップの前に実行され、前記解放するステップは、前記構成するステップの後または前記取外すステップの後に実行される、請求項11に記載の方法。
- 非ヒト動物患者の滑膜関節を治療するための方法であって、前記関節は2つの関節面を含み、前記方法は、
請求項1に記載の装置を提供するステップを備え、熱可塑性特性を有する前記材料は別個のピン(20)に含まれており、前記方法はさらに、
軟骨下骨組織を少なくとも部分的に露出するように前記関節の前記関節面を準備するステップと、
準備した前記関節面同士の間に前記装置を位置決めするステップと、
前記ピン(20)を前記関節部(1および2)の外側の間に、または前記関節部(1および2)に含まれる穿孔したシースもしくはトンネルに押込み、同時に、熱可塑性特性を有する前記材料の少なくとも一部を液化するのに十分な時間だけ前記ピン(20)を振動させ、前記材料を前記シースまたはトンネルの穿孔を通って流れさせて、露出した前記軟骨下骨組織に浸透させるステップと、
液化した前記材料を凝固させて、前記装置と露出した前記軟骨下骨組織との間に形状嵌合接続を構成するステップと、
前記関節の少なくとも制限された関節接合および平行移動を可能にするように、前記一時的なコネクタ部(4)を取外すステップとを備える、方法。 - 前記関節を固定するステップと、前記関節を固定した状態から解放するステップとをさらに備え、前記固定するステップは、前記押込むステップまたは前記位置決めするステップの前に実行され、前記解放するステップは、前記構成するステップの後または前記取外すステップの後に実行される、請求項13に記載の方法。
- 前記固定するステップでは、カニューレ挿入案内工具の遠面に設けられた鋭利な突出部が、一対の前記関節面の両側で骨表面に押入れられる、請求項12または請求項14に記載の方法。
- 前記関節の前記関節面を準備する前記ステップは、少なくとも一対の対向する溝を準備するステップを含み、前記一対の各溝は前記関節面の各々に配置される、請求項11〜15のいずれか一項に記載の方法。
- 前記コネクタ部(4)を取外す前記ステップは、前記関節から前記コネクタ部(4)を移植方向と反対の方向に引抜くステップを含む、請求項11〜16のいずれか一項に記載の方法。
- 装置を提供する前記ステップは、前記装置または前記コネクタ部(4)の近面を振動工具(5)の遠端に接続するステップを含み、前記コネクタ部(4)を取外す前記ステップは、前記振動工具(5)およびこれに接続された前記コネクタ部(4)を前記関節から引離すステップを含む、請求項17に記載の方法。
- 装置を提供する前記ステップは、生物学的分解可能または生物学的再吸収可能な材料からなるコネクタ部(4)を提供するステップを含み、前記コネクタ部(4)を取外す前記ステップは、前記コネクタ部を前記関節内で生物学的に再吸収または生物学的に分解させるステップを含む、請求項11〜16のいずれか一項に記載の方法。
- 最小侵襲手術技術を用いて実行される、請求項11〜19のいずれか一項に記載の方法。
- 前記関節は蝶番関節であり、前記方法は横からのアプローチによって実行される、請求項11〜20のいずれか一項に記載の方法。
- ヒト患者または非ヒト動物患者の滑膜関節を治療するためのシステムであって、前記関節は2つの関節面を含み、前記システムは、
請求項1に記載の装置を備え、熱可塑性特性を有する前記材料は前記関節部(1および2)に組込み可能であり、前記システムはさらに、
前記関節面同士の間に前記装置を押込み、同時に、熱可塑性特性を有する前記材料の少なくとも一部を液化してエネルギ伝達の後に露出した軟骨下骨組織に浸透させるのに十分な時間だけ前記装置を振動させるための手段と、
エネルギ伝達の後に凝固して、前記装置と露出した前記軟骨下骨組織との間に形状嵌合接続を構成し、
前記関節の少なくとも制限された関節接合および平行移動を可能にするように、前記一時的なコネクタ部(4)を取外すための手段とを備える、システム。 - ヒト患者または非ヒト動物患者の滑膜関節を治療するためのシステムであって、前記関節は2つの関節面を含み、前記システムは、
請求項10に記載の装置を備え、熱可塑性特性を有する前記材料は別個のピン(20)に含まれており、前記システムはさらに、
準備した前記関節面同士の間に前記装置を位置決めするための手段と、
前記ピン(20)を前記関節部(1および2)の外側の間に、または前記関節部(1および2)に含まれる穿孔したシースもしくはトンネルに押込み、同時に、熱可塑性特性を有する前記材料の少なくとも一部を液化してエネルギ伝達の後に前記シースまたはトンネルの穿孔を通って流れさせ、露出した軟骨下骨組織に浸透させるのに十分な時間だけ前記ピン(20)を振動させるための手段と、
エネルギ伝達の後に凝固して、前記装置と露出した前記軟骨下骨組織との間に形状嵌合接続を構成し、
前記関節の少なくとも制限された関節接合および平行移動を可能にするように、前記一時的なコネクタ部(4)を取外すための手段とを備える、システム。
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PL2965721T3 (pl) | 2018-08-31 |
US10390957B2 (en) | 2019-08-27 |
EP2618786A1 (en) | 2013-07-31 |
US20130211530A1 (en) | 2013-08-15 |
PL2618786T3 (pl) | 2016-03-31 |
RU2013116764A (ru) | 2014-10-27 |
EP2618786B1 (en) | 2015-10-14 |
WO2012037698A1 (en) | 2012-03-29 |
HK1187231A1 (zh) | 2014-04-04 |
JP2013540473A (ja) | 2013-11-07 |
EP2965721A1 (en) | 2016-01-13 |
ES2690276T3 (es) | 2018-11-20 |
KR20140024239A (ko) | 2014-02-28 |
CA2811327C (en) | 2018-05-29 |
CN103298430A (zh) | 2013-09-11 |
CN105361979A (zh) | 2016-03-02 |
US9585756B2 (en) | 2017-03-07 |
US20170128214A1 (en) | 2017-05-11 |
HK1219647A1 (zh) | 2017-04-13 |
KR101830462B1 (ko) | 2018-02-20 |
EP2965721B1 (en) | 2018-03-28 |
CN105361979B (zh) | 2017-08-29 |
CA2811327A1 (en) | 2012-03-29 |
BR112013008108A2 (pt) | 2016-08-09 |
CN103298430B (zh) | 2016-01-13 |
RU2585694C2 (ru) | 2016-06-10 |
BR112013008108B1 (pt) | 2020-06-23 |
ES2559038T3 (es) | 2016-02-10 |
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