JP4906723B2 - 生分解性および非生分解性領域を有する外科用補綴物 - Google Patents
生分解性および非生分解性領域を有する外科用補綴物 Download PDFInfo
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- JP4906723B2 JP4906723B2 JP2007525850A JP2007525850A JP4906723B2 JP 4906723 B2 JP4906723 B2 JP 4906723B2 JP 2007525850 A JP2007525850 A JP 2007525850A JP 2007525850 A JP2007525850 A JP 2007525850A JP 4906723 B2 JP4906723 B2 JP 4906723B2
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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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- 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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- 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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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Description
本願は、2004年8月13日出願の「生分解性および非生分解性領域を有する外科用補綴物(SURGICAL PROSTHESIS HAVING BIODEGRADABLE AND NONBIODEGRADABLE REGIONS)」という名称の米国仮特許出願第60/601,414号(代理人整理番号MB9800PR)および2004年10月28日出願の「生分解性および非生分解性領域を有する外科用補綴物(SURGICAL PROSTHESIS HAVING BIODEGRADABLE AND NONBIODEGRADABLE REGIONS)」という名称の米国仮特許出願第60/623,524号(代理人整理番号MB9828PR)に関する利益を主張するものであり、これら両出願の全内容を参照により本明細書中に援用する。本願は、2003年7月31日出願の「吸収性薄膜(RESORBABLE THIN MEMBRANES)」という名称の米国特許出願第10/631,980号(代理人整理番号MA9604P)および2003年2月27日出願の「骨成長の制御方法(METHODS OF GOVERNING BONE GROWTH)」という名称の米国特許出願第10/375,451号(代理人整理番号MA9608P)の一部継続出願であり、これら両出願の全内容を参照により本明細書中に援用する。
本発明は、腹部ヘルニアを治療するための外科用補綴物に関する。
ヘルニアは、腹部器官(例えば腸および/または網)をはみ出させる腹壁の丈夫なまたは筋膜の層の欠陥として定義される。いったんそれらの正常な位置から脱するとそれらの器官は、狭くなるかまたは捻られるようになる恐れがある。大部分の通常のヘルニアの症状は、腹部の痛み、悪心、嘔吐、および見え隠れすることのある腹部の腫脹または腫瘤である。ヘルニアは、一般には先行する外科的切開によってひき起されるが、以前の手術がなくても起こることもある。
本発明によるヘルニアの修復用補綴物は、付着抵抗生分解性領域と、対向する組織内殖生分解性領域とを備える。この補綴物が患者中に埋め込まれると、付着抵抗生分解性領域がヘルニアの筋膜の欠陥部を覆い、組織内殖生分解性領域は、実質上宿主の皮下組織(例えば脂肪)層にのみ曝されている状態でこの付着抵抗生分解性領域上に配置される。この位置づけは、組織内殖生分解性領域が宿主の体組織と堅固に合体するようになることを可能にする。付着抵抗生分解性領域は、それら内部器官と対峙し、癒着および/または腸閉塞の発生を低減させる。
本明細書の文脈、この詳細な説明、および当業者の知識から明らかであるような任意のそれらの組合せに含まれる特徴が互いに相反しないという条件で、本明細書に記載される任意の特徴または特徴の組合せが本発明の範囲に包含される。さらに任意の特徴または特徴の組合せを本発明の任意の実施形態からはっきり除外することもできる。本発明を要約する目的で本発明の幾つかの態様、利点、および新規な特徴を本明細書中に記載する。もちろん、本発明のある特定の実施形態中では必ずしもこのようなすべての態様、利点、または特徴が具体的に表現されないことを理解されたい。
組織内殖生分解性領域12を、例えば規則的または不規則に分布した胞および/または細孔を含んだ目の粗い、非平滑の、および/または造作に特徴のある表面を有するように形成することができる。さらなる実施形態では組織内殖生分解性領域12を、これに加えてまたはその代わりに平坦でない(例えば、亀裂のある、破れた、ざらざらした、または剥げた)表面を有するように形成することもでき、それは上記の場合と同様に、宿主組織と組織内殖生分解性領域12との間に組織の乱れ(例えば、潜在的な組織の炎症および/または瘢痕)をひき起す可能性がある。
現在実施されているように、組織内殖生分解性領域12は第一の材料を含み、付着抵抗生分解性領域14は第一の材料とは異なる第二の材料を含む。修正実施形態では組織内殖生分解性領域12および付着抵抗生分解性領域14が、同一または実質的に同一の材料を含むことができる。他の実施形態では組織内殖生分解性領域12および付着抵抗生分解性領域14は、例えばその組織内殖生分解性領域12および付着抵抗生分解性領域14の少なくとも一方に導入された添加剤から得られる別の材料を含むことができる。
付着抵抗生分解性領域14の生分解時間または速度は、組織内殖生分解性領域12の生分解速度よりも実質上大きい。この速度差は、例えば(a)添加剤および/または(b)ポリマー構造/組成の使用により実現することができる。
一具体例によればこの特性は、組織内殖生分解性領域12および付着抵抗生分解性領域14の少なくとも一方に添加剤を取り込むことによって影響を受ける生分解の時間または速度である。本発明の一具体例によれば付着抵抗生分解性領域14の生分解速度は、組織内殖生分解性領域12の生分解速度よりも実質上大きい。この生分解速度を調整するために組織内殖生分解性領域12および付着抵抗生分解性領域14の一方または両方に促進剤または遅延剤を与えることができる。
別の具体例によればその特徴は、組織内殖生分解性領域12および付着抵抗生分解性領域14の少なくとも一方のポリマー組成である。組織内殖生分解性領域12の生分解速度は比較的遅い可能性があり、かつ/または付着抵抗生分解性領域14の生分解速度よりも遅い可能性がある。そのような生分解速度を得るにはその組織内殖生分解性領域12を、例えばより迅速に生分解するポリマーと比べて、かつ/または付着抵抗生分解性領域14と比べて主鎖に加水分解に安定な結合を有する合成ポリマーで形成することができる。組織内殖生分解性領域12の形成に適した一般的な化学官能基には、本明細書中ですでに述べたものに加えてエステル類、酸無水物、オルトエステル類、およびアミド類を挙げることができる。ポリマー主鎖の化学構造によっては分解が表面浸食または全体浸食のいずれかにより起こることができる。表面浸食は、その浸食速度が組織内殖生分解性領域12または付着抵抗生分解性領域14のどちらかの大部分のポリマー中への水の浸透速度を超える場合に起こることができる。このタイプの分解は、例えばポリ(酸無水物)およびポリ(オルトエステル)において得ることができる。本明細書中で述べる全分解生体吸収性ポリマーの加水分解は、一般には最初に分子量の減損、続いて第二段階で質量の減損によって進行することができる。一般に加水分解(酵素が介在する加水分解を含め)は、生体内でのヘテロ鎖ポリマーに対する好ましい分解機構である。例としてポリ(ε−カプロラクトン)とポリ(ラクチド)などの関連ポリエステル類およびそのコポリマーの分解は、まずカルボン酸末端基の生成によって自己触媒される、エステル結合の酵素によらない加水分解、続いて質量の減損を伴う。
さらにその特徴は、例えば生分解性外科用補綴物10の膨れ、しわ、および/またはカールの影響を和らげることができる強度、構造的完全さ、または関連パラメータであることができる。本発明は生分解性外科用補綴物の強度および構造的完全さのかなり大きな部分を組織内殖生分解性領域12に割り当てようと努めているので、強度または構造的完全さを生分解性外科用補綴物10に付け加える視点を組織内殖生分解性領域12に向ける。
本発明の別の具体例によればその特徴は、宿主組織中で線維芽細胞反応を促進する能力を含むことができる。組織内殖生分解性領域12は線維芽細胞反応を促進するように作製することができ、一方、付着抵抗生分解性領域14は好ましくは線維芽細胞反応をひき起さない。組織内殖生分解性領域12による線維芽細胞反応の促進は、上記で考察した特徴(例えば、添加剤によって影響を受ける生分解時間または速度、ポリマーの構造/組成によって影響を受ける生分解時間または速度、および強度または構造的完全さによって影響を受けるポリマー組成)の1つまたは複数に基づく可能性がある。何故ならば生分解性外科用補綴物10は、しっかりした把持力を獲得するように組織を反応させるためにはその構造を十分長く保つ必要があるはずであるためである。
Claims (35)
- 宿主中に埋め込むための生分解性外科用インプラントであって、組織内殖生分解性の面および付着抵抗生分解性の面を有し、非多孔性および液体に対する非透過性のいずれかの特性あるいは両特性をもつ再吸収性ポリマー基材の実質上平坦な障壁膜を備え、前記組織内殖生分解性の面および前記付着抵抗生分解性の面が、それぞれ、生分解性材料の第二の層および生分解性材料の第一の層を含み、かつ表面の様相および表面の機能の両方で相異なり、更に組織内殖生分解性の面と付着抵抗生分解性の面が実質的に同一の材料から形成され、前記組織内殖生分解性の面および前記付着抵抗生分解性の面の一方が添加剤を含み、前記添加剤が、前記組織内殖生分解性の面の生分解速度に比して前記付着抵抗生分解性の面の生分解速度を増加させるか、前記付着抵抗生分解性の面の生分解速度に比して前記組織内殖生分解性の面の生分解速度を低下させることを特徴とする、生分解性外科用インプラント。
- 前記組織内殖生分解性の面および前記付着抵抗生分解性の面の一方が、前記組織内殖生分解性の面および前記付着抵抗生分解性の面のもう一方の第二の組成物に比して面の強度または構造的完全さに影響を及ぼす第一の組成物を含む、請求項1に記載の生分解性外科用インプラント。
- 前記第一の組成物は、前記組織内殖生分解性の面が仮に前記第二の組成物から形成されたならば有したであろう強度よりも高い強度を前記組織内殖生分解性の面に与える、請求項2に記載の生分解性外科用インプラント。
- 前記第一の組成物が強化用繊維および補強用繊維を含む、請求項3に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面が第一の組成物を含み、前記付着抵抗生分解性の面が第二の組成物を含み、かつ前記付着抵抗生分解性の面が、仮に前記第一の組成物から形成されたならばその付着抵抗生分解性の面によってもたらされたであろう付着抵抗性よりも大きい付着抵抗性を備える、請求項1に記載の生分解性外科用インプラント。
- 前記第一の組成物が第一のポリマー組成物を含み、かつ前記第二の組成物が前記第一のポリマー組成物とは異なる第二のポリマー組成物を含む、請求項2〜5のいずれか一項に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントが、実質的に均質な組成を有する再吸収性ポリマー基材の単一層を含有し、前記再吸収性ポリマー基材の単一層の厚さが約500ミクロンを超える、請求項1に記載の生分解性外科用インプラント。
- 前記再吸収性ポリマー基材の単一層が非多孔性である、請求項7に記載の生分解性外科用インプラント。
- 前記再吸収性ポリマー基材の単一層が、ポリラクチドポリマーと、2種類以上のポリラクチドのコポリマーとからなる群から選択される材料を含む、請求項7に記載の生分解性外科用インプラント。
- 前記再吸収性ポリマー基材がポリ(L−ラクチド−co−D,L−ラクチド)である、請求項7に記載の生分解性外科用インプラント。
- 前記再吸収性ポリマー基材の単一層が流体透過性でない、請求項7に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントの一方の面のみが、抗骨剤、細胞移動に影響を及ぼすような走化性物質、細胞移動に影響を及ぼすような抑制性物質、細胞増殖に影響を及ぼすような分裂成長因子、細胞分化に影響を及ぼすような成長因子、および血管形成を促進する因子のうちの少なくとも1種類を含浸される、請求項1に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントが無菌包装材料中に密封される、請求項1に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントが瘢痕形成を防止する、請求項1に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントが組織の癒着を防止する、請求項1に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントが、ポリラクチドポリマーと、少なくとも2種類のポリラクチドのコポリマーとを含む、請求項1に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントが流体に対して不透過性である、請求項1に記載の生分解性外科用インプラント。
- 前記付着抵抗生分解性の面、および前記組織内殖生分解性の面が、異なる材料を含む、請求項1に記載の生分解性外科用インプラント。
- 前記第一および第二の層が非多孔性である、請求項18に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面が、(a)表面形態の形での表面の様相、および(b)表面組成の形での表面機能の1つまたは複数を用いて作製され、その様相または機能が前記付着抵抗生分解性の面のものと異なり、かつ前記付着抵抗生分解性の面に比して前記宿主組織中での強度、寿命、および実質的な線維芽細胞反応のうちの1つまたは複数を促進する、請求項1に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面が表面形態を用いて作製され、その表面形態が前記付着抵抗生分解性の面のものと異なり、かつ前記付着抵抗生分解性の面と比べて前記宿主組織中での強度、寿命、および実質的な線維芽細胞反応のうちの1つまたは複数を促進する、請求項20に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面および前記付着抵抗生分解性の面が、実質的に同一の材料から形成される、請求項21に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面および前記付着抵抗生分解性の面が、同一材料から形成される、請求項1または21に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントが、前記組織内殖生分解性の面と前記付着抵抗生分解性の面の両方を形成する再吸収性ポリマーの単一層を含有する、請求項1または21に記載の生分解性外科用インプラント。
- 前記生分解性外科用インプラントが再吸収性ポリマー基材の単一層を含有し、前記組織内殖生分解性の面が前記再吸収性ポリマー基材と一体に形成され、かつ前記付着抵抗生分解性の面が前記再吸収性ポリマー基材と一体に形成される、請求項1または21に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面が、目の粗い、非平滑の、かつ造作に特徴のある表面を有するように形成される、請求項21に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面が、胞および細孔のうちの1種類または複数種類を有するように形成される、請求項26に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面が、前記組織内殖生分解性の面上に不規則に分布した胞および細孔のうちの1種類または複数種類を有するように形成される、請求項27に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面が、不規則な仕方で分布しかつ裸眼で見える細孔を有するように形成される、請求項27に記載の生分解性外科用インプラント。
- 前記組織内殖生分解性の面が、前記宿主組織と前記組織内殖生分解性の面との間の組織の乱れおよび炎症をひき起す亀裂のある、破れた、または剥げた表面の1種または複数種を有するように形成される、請求項26に記載の生分解性外科用インプラント。
- 前記付着抵抗生分解性の面が、(a)表面形態、および(b)表面組成の1つまたは複数を用いて作製され、その表面の形態または組成が前記組織内殖生分解性の面のものと異なり、かつ前記組織内殖生分解性の面に比して前記生分解性外科用インプラントと前記宿主組織の間の抗付着効果を促進する、請求項1に記載の生分解性外科用インプラント。
- 前記付着抵抗生分解性の面が表面形態を用いて作製され、その表面形態が前記組織内殖生分解性の面のものと異なり、かつ前記組織内殖生分解性の面に比して前記生分解性外科用インプラントと前記宿主組織の間の抗付着効果を促進する、請求項31に記載の生分解性外科用インプラント。
- 前記付着抵抗生分解性の面が実質上平滑な表面を備える、請求項31に記載の生分解性外科用インプラント。
- 前記付着抵抗生分解性の面が生分解性材料の第一の層を備え、かつ前記組織内殖生分解性の面が生分解性材料の第二の層を備える、請求項31に記載の生分解性外科用インプラント。
- 前記付着抵抗生分解性の面が非多孔性の生分解性材料の第一の層を備え、かつ前記組織内殖生分解性の面が非多孔性の生分解性材料の第二の層を備える、請求項31に記載の生分解性外科用インプラント。
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Also Published As
Publication number | Publication date |
---|---|
AU2005272684B2 (en) | 2008-12-04 |
CN101018512A (zh) | 2007-08-15 |
KR100895135B1 (ko) | 2009-05-04 |
EP1776065B1 (en) | 2012-02-15 |
ES2395154T3 (es) | 2013-02-08 |
MX2007001628A (es) | 2007-04-10 |
AU2009200816B2 (en) | 2011-07-07 |
EP1776065A4 (en) | 2009-11-11 |
US20080091276A1 (en) | 2008-04-17 |
WO2006020922A3 (en) | 2006-04-27 |
AU2009200816A1 (en) | 2009-03-19 |
HK1099679A1 (en) | 2007-08-24 |
US20080091222A1 (en) | 2008-04-17 |
EP1776065A2 (en) | 2007-04-25 |
IL181264A0 (en) | 2007-07-04 |
AU2011202203A1 (en) | 2011-06-02 |
AU2005272684A1 (en) | 2006-02-23 |
CA2573564A1 (en) | 2006-02-23 |
CA2573564C (en) | 2010-04-06 |
ATE545384T1 (de) | 2012-03-15 |
AU2011202203B2 (en) | 2012-07-26 |
CN101018512B (zh) | 2011-05-18 |
WO2006020922A2 (en) | 2006-02-23 |
JP2008509752A (ja) | 2008-04-03 |
KR20070046109A (ko) | 2007-05-02 |
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