JP5603423B2 - 胸部外科手術用の移植材料 - Google Patents
胸部外科手術用の移植材料 Download PDFInfo
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- A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2240/001—Designing or manufacturing processes
- A61F2240/002—Designing or making customized prostheses
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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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- A61L2430/00—Materials or treatment for tissue regeneration
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
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- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
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Description
Claims (47)
- 胸部外科手術用の医療デバイスであって、
生体適合性材料のサンプル(13)を備え、この生体適合性材料のサンプル(13)が、第1エッジ(15)および第2エッジ(17)を含み、
前記第1エッジ(15)が、前記第2エッジ(17)から離れるように湾曲する凸状部を有し、前記第2エッジ(17)が、前記第1エッジ(15)から離れるように湾曲する凸状部を含み、
前記第1エッジ(15)の凸状部が第1頂点を含み、前記第2エッジ(17)の凸状部が第2頂点を含み、
前記生体適合性材料のサンプル(13)が、当該生体適合性材料のサンプル(13)と一致する縦軸(y)と、当該生体適合性材料のサンプル(13)と一致する垂直軸(x)とを含み、前記垂直軸(x)が、前記第1および第2頂点を通り、前記生体適合性材料のサンプル(13)の前記縦軸(y)に沿う長さが、前記生体適合性材料のサンプル(13)の前記垂直軸(x)に沿う長さよりも長く、
前記第1エッジ(15)の前記第1頂点が、前記第1エッジ(15)の第1焦点から第1長さ離れており、前記第2エッジ(17)の前記第2頂点が、前記第2エッジ(17)の第2焦点から第2長さ離れており、前記第2長さが前記第1長さよりも大きく、
前記生体適合性材料のサンプル(13)が、前記垂直軸(x)に関して対称であり、
前記生体適合性材料のサンプル(13)が、無細胞組織マトリクスを含むことを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記生体適合性材料のサンプル(13)が、両凸の形状であることを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記第1エッジ(15)が、実質的に放物線状に湾曲していることを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記第2エッジ(17)が、実質的に放物線状に湾曲していることを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記第1エッジ(15)が、非凸状の部分(29)をさらに含むことを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記第2エッジ(17)が、非凸状の部分(31)をさらに含むことを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記第2エッジ(17)が、実質的に直線状の部分をさらに含むことを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記第2エッジ(17)が、凹状の部分をさらに含むことを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記第1エッジ(15)および前記第2エッジ(17)が、頂部(19)で結合されていることを特徴とする医療デバイス。 - 請求項9に記載の医療デバイスにおいて、
前記頂部(19)が丸みを帯びていることを特徴とする医療デバイス。 - 請求項9に記載の医療デバイスにおいて、
前記頂部(19)が四角い形状とされることを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記生体適合性材料のサンプル(13)が、前記縦軸(y)に関して非対称であることを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記第1エッジ(15)が、実質的に放物線状に湾曲しており、
前記第2エッジ(17)が、実質的に放物線状に湾曲しており、
前記第1エッジ(15)および前記第2エッジ(17)が、2つの頂部(19)で結合することを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記無細胞組織マトリクスが、ヒト以外の動物からの脱細胞化コラーゲン含有組織マトリクスを含むことを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記無細胞組織マトリクスが、上皮基底膜を全くまたは実質的に有していないことを特徴とする医療デバイス。 - 請求項1に記載の医療デバイスにおいて、
前記無細胞組織マトリクスが、真皮組織マトリクスであることを特徴とする医療デバイス。 - 請求項14に記載の医療デバイスにおいて、
前記ヒト以外の動物がブタであることを特徴とする医療デバイス。 - 請求項14に記載の医療デバイスにおいて、
前記ヒト以外の動物内の組織がガラクトースα−1,3−ガラクトースエピトープを全くまたは実質的に持たないように、前記ヒト以外の動物が遺伝子操作されていることを特徴とする医療デバイス。 - 胸部外科手術用の医療デバイスであって、
生体適合性材料のサンプル(13)と、この生体適合性材料のサンプル(13)の少なくとも一部を横切る弓形のパターンを形成するミシン目のセット(23)とを備えることを特徴とする医療デバイス。 - 請求項19に記載の医療デバイスにおいて、
前記ミシン目のセット(23)が、半円のパターンで配列されていることを特徴とする医療デバイス。 - 請求項19に記載の医療デバイスにおいて、
前記ミシン目のセット(23)が、メッシュ状のパターンを形成することを特徴とする医療デバイス。 - 請求項19に記載の医療デバイスにおいて、
前記ミシン目のセット(23)が、一連の平行なスリット(25)を備え、前記スリットがほぼ均一な長さを有し、ほぼ均一な間隙距離で、隣接するスリットが長手方向に分離され、ほぼ均一な水平隔離距離で、隣接する平行なスリット(25)が分離されることを特徴とする医療デバイス。 - 請求項22に記載の医療デバイスにおいて、
前記長さが、0.1mmと20mmの間であることを特徴とする医療デバイス。 - 請求項22に記載の医療デバイスにおいて、
前記長さが、4mmと8mmの間であることを特徴とする医療デバイス。 - 請求項22に記載の医療デバイスにおいて、
前記間隙距離が、0.1mmと20mmの間であることを特徴とする医療デバイス。 - 請求項22に記載の医療デバイスにおいて、
前記間隙距離が、2mmと6mmの間であることを特徴とする医療デバイス。 - 請求項22に記載の医療デバイスにおいて、
前記水平隔離距離が、0.1mmと20mmの間であることを特徴とする医療デバイス。 - 請求項22に記載の医療デバイスにおいて、
前記水平隔離距離が、2mmと6mmの間であることを特徴とする医療デバイス。 - 請求項22に記載の医療デバイスにおいて、
隣接する平行なスリット(25)が、長手方向に互いにオフセットされていることを特徴とする医療デバイス。 - 請求項19に記載の医療デバイスにおいて、
個々のミシン目(23)が、弓形であることを特徴とする医療デバイス。 - 請求項19に記載の医療デバイスにおいて、
前記生体適合性材料のサンプル(13)が、無細胞組織マトリクスを含むことを特徴とする医療デバイス。 - 請求項31に記載の医療デバイスにおいて、
前記無細胞組織マトリクスが、ヒト以外の動物からの脱細胞化コラーゲン含有組織マトリクスを含むことを特徴とする医療デバイス。 - 請求項31に記載の医療デバイスにおいて、
前記無細胞組織マトリクスが、上皮基底膜を全くまたは実質的に持たないことを特徴とする医療デバイス。 - 請求項31に記載の医療デバイスにおいて、
前記無細胞組織マトリクスが、真皮組織マトリクスであることを特徴とする医療デバイス。 - 請求項32に記載の医療デバイスにおいて、
前記ヒト以外の動物がブタであることを特徴とする医療デバイス。 - 請求項32に記載の医療デバイスにおいて、
前記ヒト以外の動物内の組織がガラクトースα−1,3−ガラクトースエピトープを全くまたは実質的に持たないように、前記ヒト以外の動物が遺伝子操作されていることを特徴とする医療デバイス。 - 1またはそれ以上の移植デバイスの製造方法であって、
生体適合性材料のシートを提供するステップと、
予め設定された体積を有する胸部インプラント(21)の表面の一部に合うようにサイズおよび形状が調節された生体適合性材料(13)のシートから1またはそれ以上のサンプルを切断するステップとを備え、
前記1またはそれ以上のサンプルが、第1エッジ(15)および第2エッジ(17)を含み、前記第1エッジ(15)が、前記第2エッジ(17)から離れるように湾曲する凸状部を有し、前記第2エッジ(17)が、前記第1エッジ(15)から離れるように湾曲する凸状部を含み、
前記第1エッジ(15)の凸状部が第1頂点を含み、前記第2エッジ(17)の凸状部が第2頂点を含み、
生体適合性材料のサンプル(13)が、当該生体適合性材料のサンプル(13)と一致する縦軸(y)と、当該生体適合性材料のサンプル(13)と一致する垂直軸(x)とを含み、前記垂直軸(x)が、前記第1および第2頂点を通り、生体適合性材料のサンプル(13)の前記縦軸(y)に沿う長さが、生体適合性材料のサンプル(13)の前記垂直軸(x)に沿う長さよりも長く、
前記第1エッジ(15)の前記第1頂点が、前記第1エッジ(15)の第1焦点から第1長さ離れており、前記第2エッジ(17)の前記第2頂点が、前記第2エッジ(17)の第2焦点から第2長さ離れており、前記第2長さが前記第1長さよりも大きく、
前記1またはそれ以上のサンプル(13)が、前記垂直軸(x)に関して対称であり、
前記1またはそれ以上のサンプル(13)が、無細胞組織マトリクスを含むことを特徴とする方法。 - 請求項37に記載の方法において、
前記1またはそれ以上の移植デバイスの少なくとも一部を横切る弓形のパターンを形成するように、ミシン目のセット(23)を形成するステップをさらに備えることを特徴とする方法。 - 請求項37に記載の方法において、
前記胸部インプラント(21)が、丸みを帯びたインプラントであることを特徴とする方法。 - 請求項37に記載の方法において、
前記胸部インプラント(21)が、解剖学的インプラントであることを特徴とする方法。 - 請求項37に記載の方法において、
前記胸部インプラント(21)の体積が、400ccと550ccの間であることを特徴とする方法。 - 請求項37に記載の方法において、
前記胸部インプラント(21)の体積が、250ccと400ccの間であることを特徴とする方法。 - 請求項37に記載の方法において、
前記胸部インプラント(21)の体積が、100ccと250ccの間であることを特徴とする方法。 - 請求項37に記載の方法において、
前記生体適合性材料のシートを提供するステップが、
ヒト以外の動物からのコラーゲン含有組織を提供するステップと、
前記組織を処理して、上皮基底膜を全くまたは実質的に持たない無細胞の組織を与えるステップとを備え、前記処理により前記無細胞組織マトリクスが生成されることを特徴とする方法。 - 請求項44に記載の方法において、
前記ヒト以外の動物がブタであることを特徴とする方法。 - 請求項44に記載の方法において、
前記組織が真皮であることを特徴とする方法。 - 請求項44に記載の方法において、
前記ヒト以外の動物内の組織がガラクトースα−1,3−ガラクトースエピトープを全くまたは実質的に持たないように、前記動物が遺伝子操作されていることを特徴とする方法。
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AU2010276354B2 (en) | 2014-10-02 |
CN102470032B (zh) | 2015-07-15 |
JP2013500062A (ja) | 2013-01-07 |
CA3031402A1 (en) | 2011-01-27 |
EP2456391B1 (en) | 2020-05-13 |
US10449034B2 (en) | 2019-10-22 |
EP3711710A1 (en) | 2020-09-23 |
US10835370B2 (en) | 2020-11-17 |
EP2456391A2 (en) | 2012-05-30 |
CA3031402C (en) | 2021-10-19 |
US8986377B2 (en) | 2015-03-24 |
WO2011011394A3 (en) | 2011-03-17 |
AU2010276354A1 (en) | 2012-02-02 |
US20110022171A1 (en) | 2011-01-27 |
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