JP5579904B2 - 不織状の組織支持骨格 - Google Patents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
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- 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
- A61F2/38—Joints for elbows or knees
- A61F2/3872—Meniscus for implantation between the natural bone surfaces
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/18—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/06—Materials or treatment for tissue regeneration for cartilage reconstruction, e.g. meniscus
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Description
例えば、粘膜を含む生殖組織の種々の誘導体(自己移植片、同種移植片および異種移植片)、例えば、肝臓の基底膜を含む肝組織の種々の誘導体(自己移植片、同種移植片および異種移植片)、皮膚組織の種々の誘導体、高濃度血小板血漿(PRP)、低濃度血小板血漿、骨髄吸引液、鉱物質除去した骨の基質、インスリン誘導型の増殖因子、全血、フィブリンおよび血液凝固物の1種類以上を含む。精製したECMおよびその他のコラーゲンの供給源はまた適当な生物学的に誘導した物質でもある。さらに、他の上記のような物質がこの整形外科の分野において治療的価値を有していれば、これらの物質の少なくとも一部が本発明において有用性を有することになり、このような物質は他に明らかに限定されていない限りにおいて、「生物学的に誘導されている一定の物質(biologically derived agent)」および「生物学的に誘導されている種々の物質(biologically derived agents)」の意味に当然に含まれる。
本発明により作成した支持骨格は、以下において説明されているように、一連の縫合糸の保持および剛性の試験においてそれぞれ調査されて従来の種々の移植片に対して比較されている。シリーズ1において、テーパー状の針を伴う3−0ポリプロピレン縫合糸(エシコン社(Ethicon),8665H)を5mm×11mmの長方形の支持骨格の中に入れた。図4において示されているように、縫合糸20は1.5mmのバイト距離(Bite-Distance)22を有しており、一定のクランプ24が下部に沿って配置されている。この支持骨格の長方形の部分の半分を即時に機械的に試験し、その残りの半分をDPBS(ギブコ社(Gibco),カタログ番号:34190−136)の中に置いて試験前に2週間にわたり37℃で培養した。
本発明の支持骨格の引張強さの特性が調べられていて、従来の半月板の移植装置に対して比べられている。一定の発泡体成分を伴うか伴わない種々の密度の不織材料の支持骨格がPDSおよびPDS/VICRYLの繊維によりそれぞれ構成されている。さらに、従来の発泡体により補強したPDSのメッシュ材料が比較のために用いられている。また、各実験はアメリカン・ソサイエティ・フォー・テスティング・アンド・マテリアルズ(American Society for Testing and Materials)(D638−02,テスト・メソッド・フォー・テンシル・プロパテイーズ・オブ・プラスチック・アンド・D1708−02a,スタンダード・テスト・メソッド・フォー・テンシル・プロパテイーズ・オブ・プラスチック・バイ・ユース・オブ・マイクロテンシル・スペシミンズ(D638-02, Test Method for Tensile Properties of Plastics and D1708-02a, Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens)の基準に従って行なわれている。
本発明の支持骨格の引張強さの特性が異なる厚さおよび材料組成の種々の支持骨格について調べられている。第1および第2の支持骨格はPDSおよびVICRYLの50/50の一定の混合物により構成されていて、1mmおよび0.5mmの厚さをそれぞれ有している。また、第3の支持骨格はPDSおよびVICRYLの40/60の一定の混合物により構成されていて、0.7mmの厚さを有している。さらに、これらの不織材料の支持骨格は全て240mg/ccの一定密度を有しており、発泡体成分を含まない。それぞれの実験はアメリカン・ソサイエティ・フォー・テスティング・アンド・マテリアルズ(American Society for Testing and Materials)(D638−02,テスト・メソッド・フォー・テンシル・プロパテイーズ・オブ・プラスチック・アンド・D1708−02a,スタンダード・テスト・メソッド・フォー・テンシル・プロパテイーズ・オブ・プラスチック・バイ・ユース・オブ・マイクロテンシル・スペシミンズ(D638-02, Test Method for Tensile Properties of Plastics and D1708-02a, Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens)の基準に従って行なわれている。
PRP単独に比較した場合の50/50のPDS/VICRYLの不織材料の治癒能力が調査されている。12体の成熟した動物体が4体の動物体の3個のグループに分けられ、それぞれが一定の不織材料の支持骨格および高濃度血小板血漿(「PRP」)またはPRP単独のいずれかの修復に対応している。グループ1は35%/65%のPGA/PCLのコポリマーの発泡体および0.5mlのPRPを伴う一定の50%/50%のPDS/VICRYLの不織材料の支持骨格(236.6mg/cc)(1mmの厚さ)により移植されており、グループ2は0.5mlのPRPを伴う一定の50%/50%のPDS/VICRYLの不織材料の支持骨格(236.6mg/cc)(1mmの厚さ)により移植されており、グループ3は0.5mlのPRPにより移植されている。移植の6週間後に治癒応答を全体的に且つ組織学的に評価した。
(1)生体適合性の半月板修復装置において、
一定の半月板の中における一定の欠損部分に対して接触して配置されることに適合している一定の生体適合性の組織修復用の支持骨格を備えており、この支持骨格が一定の不織状の高分子材料を含み、さらにこの支持骨格が約1.5MPAよりも高い一定の弾性率おおよび約6Nよりも大きい一定の縫合糸引出強さを有している修復装置。
(2)前記組織修復用の支持骨格が約2MPaよりも大きい一定の最大応力を有している実施態様1に記載の修復装置。
(3)前記組織修復用の支持骨格が約45Nよりも小さい一定の縫合糸引出強さを有している実施態様1に記載の修復装置。
(4)前記組織修復用の支持骨格が約40MPaよりも小さい一定の弾性率を有している実施態様1に記載の修復装置。
(5)前記組織修復用の支持骨格が約0.5mm乃至1.5mmの範囲内の一定の厚さを有している実施態様1に記載の修復装置。
(7)前記不織状の高分子材料が一定の合成ポリマーを含む実施態様1に記載の修復装置。
(8)前記組織修復用の支持骨格が生体吸収性である実施態様1に記載の修復装置。
(9)前記不織状の高分子材料が一定の乾式法により形成されている一定の材料を含む実施態様1に記載の修復装置。
(10)前記不織状の高分子材料がグリコリド、ラクチド、カプロラクトン、トリメチレン・カーボネート、ポリビニル・アルコール、およびジオキサノンから成る群から選択されるモノマーから誘導されている少なくとも1種類のポリマーにより形成されている実施態様1に記載の修復装置。
(12)前記不織状の高分子材料がポリグリコール酸およびポリ乳酸の一定のコポリマーを含む実施態様10に記載の修復装置。
(13)さらに、細胞の増殖を刺激するために有効な少なくとも1種類の生体活性な物質を備えている実施態様1に記載の修復装置。
(14)前記生体活性な物質が一定の高濃度血小板血漿、軟骨由来型形態発生蛋白質、組換え型ヒト増殖因子、およびこれらの組み合わせ物から成る群から選択されている実施態様13に記載の修復装置。
(15)さらに、前記組織修復用の支持骨格の上に配置されてその組織修復用の支持骨格の近くの自然な組織に組み込むために有効な一定の生育可能な組織サンプルを備えている実施態様1に記載の修復装置。
(17)前記不織状の高分子材料がヒート・セット型である実施態様1に記載の修復装置。
(18)前記不織状の高分子材料の繊維の配向が等方性である実施態様1に記載の修復装置。
(19)生体適合性の半月板修復装置において、
一定の半月板の中における一定の欠損部分に対して接触して配置されることに適合している一定の生体適合性の組織修復用の支持骨格を備えており、この支持骨格が
(a)一定の高密度で乾式の不織状の高分子材料、および
(b)一定の生体適合性の発泡体を含み、
この場合に、前記支持骨格が高められた縫合糸引出強さを賦与する修復装置。
(20)前記組織修復用の支持骨格が約2MPa乃至14MPaの範囲内の一定の最大応力を有している実施態様19に記載の修復装置。
(22)前記組織修復用の支持骨格が約1.5MPa乃至40MPaの範囲内の一定の弾性率を有している実施態様19に記載の修復装置。
(23)前記組織修復用の支持骨格が約0.5mm乃至1.5mmの範囲内の一定の厚さを有している実施態様19に記載の修復装置。
(24)前記不織状の高分子材料が一定の合成ポリマーを含む実施態様19に記載の修復装置。
(25)前記組織修復用の支持骨格が生体吸収性である実施態様19に記載の修復装置。
(27)前記生体活性な物質が一定の高濃度血小板血漿、軟骨由来型形態発生蛋白質、組換え型ヒト増殖因子、およびこれらの組み合わせ物から成る群から選択されている実施態様26に記載の修復装置。
(28)さらに、前記組織修復用の支持骨格の上に配置されてその組織修復用の支持骨格の近くの自然な組織に組み込むために有効な一定の生育可能な組織サンプルを備えている実施態様19に記載の修復装置。
(29)半月板の欠損部分を外科的に修復する方法において、
約1.5MPAよりも高い一定の弾性率および約6Nよりも大きい一定の縫合糸引出強さを有している一定の生体適合性の組織修復用の支持骨格を供給する工程、
前記組織修復用の支持骨格を一定の半月板の中の一定の組織欠損部分に対して接触した状態で配置する工程、および
前記組織修復用の支持骨格の位置を縫合糸により固定する工程を含み、
この場合に、前記修復用の支持骨格が高められた縫合糸引出強さを賦与することにより、半月板の治癒を促進する方法。
(30)細胞増殖を刺激するために有効な少なくとも1種類の生体活性な物質を前記組織修復用の支持骨格と共に移植する実施態様29に記載の方法。
Claims (6)
- 生体適合性の半月板修復装置において、
半月板における欠損部分に接触して配置されることに適合している生体適合性の組織修復用の支持骨格であって、(a)少なくとも120mg/ccの密度の乾式の不織状の高分子材料と、(b)生体適合性の発泡体と、を含む支持骨格と、
前記組織修復用の支持骨格の上に配置された生育可能な組織サンプルであって、該組織修復用の支持骨格の近くの自然組織に組み込むのに有効な生育可能な組織サンプルと、
を含み、
前記支持骨格が、約6N乃至45Nの範囲内の縫合糸引出強さを賦与し、かつ、約1.5MPa乃至40MPaの範囲内の弾性率を有し、
前記不織状の高分子材料が、ポリジオキサノンとポリグリコール酸およびポリ乳酸のコポリマーとからなるポリマーを含んでなり、
前記生体適合性の発泡体が、ポリグリコール酸とポリカプロラクトンとからなるポリマーを含んでなる、修復装置。 - 前記組織修復用の支持骨格が約2MPa乃至14MPaの範囲内の最大応力を有している、請求項1に記載の修復装置。
- 前記組織修復用の支持骨格が約0.5mm乃至1.5mmの範囲内の厚さを有している、請求項1に記載の修復装置。
- 前記組織修復用の支持骨格が生体吸収性である、請求項1に記載の修復装置。
- 細胞増殖を刺激するために有効な少なくとも1種類の生体活性な物質をさらに備えている、請求項1に記載の修復装置。
- 前記生体活性な物質が、高濃度血小板血漿、軟骨由来型形態発生蛋白質、組換え型ヒト増殖因子、およびこれらの組み合わせ物から成る群から選択されている、請求項5に記載の修復装置。
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US10/828,838 US8137686B2 (en) | 2004-04-20 | 2004-04-20 | Nonwoven tissue scaffold |
US10/828,838 | 2004-04-20 |
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JP2010127774A Division JP5523934B2 (ja) | 2004-04-20 | 2010-06-03 | 不織状の組織支持骨格 |
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JP2010127774A Active JP5523934B2 (ja) | 2004-04-20 | 2010-06-03 | 不織状の組織支持骨格 |
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EP (1) | EP1604622B1 (ja) |
JP (3) | JP4554425B2 (ja) |
AU (1) | AU2005201391B2 (ja) |
CA (1) | CA2504408C (ja) |
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US7316822B2 (en) | 2003-11-26 | 2008-01-08 | Ethicon, Inc. | Conformable tissue repair implant capable of injection delivery |
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EP1604622B1 (en) | 2014-05-07 |
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CA2504408C (en) | 2013-02-26 |
JP2005305163A (ja) | 2005-11-04 |
AU2005201391A1 (en) | 2005-11-03 |
CA2504408A1 (en) | 2005-10-20 |
US8137686B2 (en) | 2012-03-20 |
JP4554425B2 (ja) | 2010-09-29 |
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