JP2006102503A - 生体吸収性多孔質補強組織インプラント及びその作製方法 - Google Patents
生体吸収性多孔質補強組織インプラント及びその作製方法 Download PDFInfo
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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
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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
- A61F2/08—Muscles; Tendons; Ligaments
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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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/446—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with other specific inorganic fillers other than those covered by A61L27/443 or A61L27/46
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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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/46—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with phosphorus-containing inorganic fillers
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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
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
- A61L27/48—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix with macromolecular fillers
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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
-
- 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
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
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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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
-
- 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
- A61L2430/34—Materials or treatment for tissue regeneration for soft tissue reconstruction
Abstract
【解決手段】生体吸収性組織インプラント(10)。この組織インプラントは、生体吸収性であるのがよく、組織インプラントは、生体適合性のあるポリマーフォーム(12)から成るのがよい。ポリマーフォーム及び補強部材(14)は、凍結乾燥溶剤に溶ける。補強部材をアニール(焼なまし)すると共に(或いは)被覆するのがよい。
【選択図】図1
Description
本発明は、軟組織損傷部の修復(再建)に用いられる生体吸収性多孔質の補強された植込み可能器具並びにかかる器具の使用及び使用方法及び製造方法に関する。
例えば筋骨格組織を含む軟組織の損傷では、損傷の重傷度及び類型のような要因に応じて外科的インターベンションによる修復が必要な場合がある。かかる外科的修復は、多数の従来型外科的手技を用いることにより、例えば、損傷した組織を縫合すると共に(或いは)インプラントを損傷組織に取り付けることにより影響を受ける場合がある。インプラントは、損傷した組織に構造的支持作用をもたらすことができ、しかもこれは又、細胞を成長させることができ、かくしてより迅速な治癒をもたらす基体として役立つことが知られている。
〔特許文献1〕米国特許第6,599,323号明細書
〔特許文献2〕米国特許出願第09/747,488号明細書
生体吸収性で補強された組織インプラントが開示される。組織インプラントは、生体適合性ポリマーフォーム及び生体適合性ポリマー補強部材を有する。フォームは、凍結乾燥溶剤に溶け、補強部材は、凍結乾燥溶剤に溶ける。繊維が凍結乾燥溶剤中における溶解度が制限された生体適合性ポリマー材料で被覆されるが、このようにするかどうかは任意である。
本発明は、好ましくは生体吸収性である生体適合性組織インプラント又は「支承」器具並びにかかる器具の製造方法及び使用方法に関する。インプラントは、連続気泡構造又は独立気泡構造を持つ細孔を備えた生体吸収性ポリマーフォームの1つ以上の層を有する。1個又は複数個の補強コンポーネントも又、機械的及び取扱い特性の向上に寄与するようインプラント内に設けられている。補強コンポーネントは好ましくは、生体適合性のあるメッシュファブリックの形態をしている。補強コンポーネントは好ましくは、これ又生体吸収性である。
メッシュ材料を補強コンポーネントとして用いる場合、メッシュ開口部の密度は、所望の機械的性質を持つ結果的に得られる組織インプラントの形成における重要な要因である。密度の低い又は開放編組メッシュ材料が好ましい。メッシュ材料の密度又は「開放度」は、コンピュータとインタフェースが取られたディジタルフォトカメラを用いて評価できる。一評価例では、IBM300PLコンピュータとインタフェースを取ったソニー社のディジタルフォトカメラDKC−5000を備えたニコン社のSMZ−U Zoomを用いてメッシュの密度を測定した。20倍に拡大された各メッシュの断面のディジタル画像を、メッシュ密度を求めるためにImage-Pro Plus 4.0ソフトウェアを用いて操作した。ディジタル画像をいったんソフトウェアで捕捉すると、画像をスレッショルドしてメッシュ内の空の空間を占める面積を画像の総面積から減算できるようにした。メッシュ密度をこれが残りのディジタル画像の割合であるように読み取った。最も望ましい機械的性質を持つインプラントは、メッシュ密度が約20%〜88%、より好ましくは約20%〜55%であるインプラントであることが判明した。この研究において、メッシュを密度が45%のこれらの繊維から編成した。
寸法安定性が迅速に達成されると有利な場合がある。場合によっては、これは、結晶可能な被膜樹脂の迅速な結晶化である場合がある。ポリ(p−ジオキサノン)のポリエステル被膜は、被覆された繊維をねばねばしていて粘着性の繊維を生じさせないで、従来手段により効果的に「巻き取る」ことができるほど十分迅速に結晶化する。
非アニール95/5ポリ(ラクチド−コ−グリコリド)ヤーンメッシュの非急冷の場合及び急冷の場合(構成物YUU及びYUQ)
アニール95/5ポリ(ラクチド−コ−グリコリド)ヤーンメッシュの非急冷の場合及び急冷の場合(構成物YAU及びYAQ)
メッシュを実施例1に記載した手順に従って精錬した。精錬したメッシュをストレッチャ及びクランプ装置内に置き、かかるストレッチャ及びクランプ装置を用いてメッシュを平らに且つぴんと張った状態に保持した。次に、メッシュ/装置組立体を不活性ガスアニーリングオーブン内に置いて120℃で3時間かけてアニールした。実験の残部を実施例1と同一のやり方で実施し、一方のアニールしたメッシュを非急冷状態のままにし、他方のメッシュを急冷した。凍結乾燥サイクルも又同一であった。
アニール95/5ポリ(ラクチド−コ−グリコリド)モノフィラメントメッシュの非急冷の場合及び急冷の場合(構成物MUU及びMUQ)
アニール95/5ポリ(ラクチド−コ−グリコリド)モノフィラメントメッシュの非急冷の場合及び急冷の場合(構成物MAU及びMAQ)
ヤーンメッシュ構成物の機械的性質
実施例1及び実施例2で説明した構成物のピーク荷重を、20ポンドロードセルが装着されたInstron機械(マサチューセッツ州キャントン所在のインスロン・インコーポレイテッドのモデル4501)を用いて測定した。打抜き機を用いて試料を切断した(40mm×9.9mm)(例外として、メッシュコントロールをはさみで切断した)、各試料の厚さを試験前に測定した。各コントロール及び構成物タイプの7つの試料を測定した。ゴム引きフェースを備えた空気圧グリップを用いてサンプルを掴み、グリップ相互間の構成物の長さである20mmゲージ長が実験の開始時に存在するようにした。把持圧力を50psiに設定した。クロスヘッド速度は、毎分1インチであった。
表2は、ヤーンメッシュを備えたコントロール及び構成物についてのピーク荷重を示している。この表は、アニーリング工程及び急冷工程を実施しなければ構成物を形成できないことを示している。急冷工程を追加した場合、ヤーン補強構成物のピーク荷重を測定すると1.3ポンドである。ピーク荷重は、補強ヤーンメッシュを予備アニールすると増大する(7.0ポンド)。また、急冷工程を実施しないでアニーリング工程を追加すると、その結果ピーク荷重が増大する(2.8ポンド)。ただし、急冷を行うと改善の度合いが大きい。
モノフィラメントメッシュ構成物の機械的性質
実施例3及び実施例4で説明した構成物のピーク荷重を、20ポンドロードセルが装着されたInstron機械(マサチューセッツ州キャントン所在のインスロン・インコーポレイテッドのモデル4501)を用いて測定した。ダイカッタを用いて(鋏で切断したメッシュコントロヒルを除く)試料を切断した(40mm×9.9mm)(例外として、メッシュコントロールをはさみで切断した)、各試料の厚さを試験前に測定した。ゴム引きフェースを備えた空気圧グリップを用いてサンプルを掴み、グリップ相互間の構成物の長さである20mmゲージ長が実験の開始時に存在するようにした。把持圧力を50psiに設定した。クロスヘッド速度は、毎分1インチであった。
外科手技
ポリ(ラクチド−コ−グリコリド)モノフィラメント繊維の調製
ポリ(p−ジオキサノン)樹脂による繊維の被覆
95/5ポリ(ラクチド−コ−グリコリド)繊維へのポリ(p−ジオキサノン)被膜の付着性(結び目(ノット)試験)
ポリ(p−ジオキサノン)被膜の初期健全性を試験するため、実験例9の種々の厚さのポリ(p−ジオキサノン)被膜で被覆した95/5ポリ(ラクチド−コ−グリコリド)の繊維を結んで図10に示すように結び目を作り被膜がこの応力を受けてコア繊維から剥がれる傾向を判定した。全ての被覆厚さに関し、結び目は、コアからの被膜の剥がれの兆候を示さないでしっかりと結び付け可能であった。
ポリ(p−ジオキサノン)被膜の健全性(ワッシャ試験)
95/5ポリ(ラクチド−コ−グリコリド)繊維に対するポリ(p−ジオキサノン)被膜の非保護端部の影響(浸漬試験)
ポリジオキサン被覆95/5ポリ(ラクチド−コ−グリコリド)繊維の引張試験
グループ#1:非被覆95/5ポリ(ラクチド−コ−グリコリド)繊維(5ミル、非アニール)
グループ#2:非被覆95/5ポリ(ラクチド−コ−グリコリド)繊維(5ミル、毎分20フィートの速度で146℃においてインライン方式でアニールした)
グループ#3:ポリ(p−ジオキサノン)被覆95/5ポリ(ラクチド−コ−グリコリド)繊維(7ミル、毎分20フィートの速度で146℃においてインライン方式でアニールした)
グループ#4:ポリ(p−ジオキサノン)被覆95/5ポリ(ラクチド−コ−グリコリド)繊維(13ミル、毎分20フィートの速度で146℃においてインライン方式でアニールした)
(1)組織インプラントであって、
生体適合性ポリマーフォームを有し、前記フォームは、凍結乾燥溶剤に溶け、
生体適合性ポリマー補強部材を有し、前記補強部材は、前記凍結乾燥溶剤に溶け、
前記補強部材に被着される厚さを持つポリマー被膜を有し、前記被膜は、被覆用ポリマーから成り、前記被覆用ポリマーは、前記凍結乾燥溶剤には実質的に溶けない、組織インプラント。
(2)前記実施態様(1)記載のインプラントであって、前記ポリマーフォームは、生体吸収性である、インプラント。
(3)前記実施態様(1)記載のインプラントであって、前記ポリマーフォームは、脂肪族ポリエステル、ポリ(アミノ酸)、ポリアルキレンオキサレート、ポリアミド、チロシン誘導ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル並びにこれらのコポリマー及び配合物から成る群から選択されたポリマーから成る、インプラント。
(4)前記実施態様(1)記載のインプラントであって、ポリマーフォームは、モル比が約70/30〜約55/45のポリ(ラクチド−コ−カプロラクトン)を含む、インプラント。
(5)前記実施態様(1)記載のインプラントであって、前記ポリマーフォームは、モル比が約60/40のポリ(ラクチド−コ−カプロラクトン)を含む、インプラント。
(7)前記実施態様(1)記載のインプラントであって、前記ポリマーフォームは、モル比が約65/35のポリ(グリコリド−コ−カプロラクトン)を含む、インプラント。
(8)前記実施態様(1)記載のインプラントであって、前記ポリマーフォームは、モル比が約60/40のポリ(ラクチド−コ−カプロラクトン)とモル比が約65/35のポリ(グリコリド−コ−カプロラクトン)の配合物を含む、インプラント。
(9)前記実施態様(1)記載のインプラントであって、前記ポリマー補強部材は、複数個の粒子を含む、インプラント。
(10)前記実施態様(1)記載のインプラントであって、前記ポリマー補強部材は、少なくとも1枚のシートを含む、インプラント。
(12)前記実施態様(11)記載のインプラントであって、前記繊維は、モノフィラメントを含む、インプラント。
(13)前記実施態様(11)記載のインプラントであって、前記繊維は、マルチフィラメントヤーンを含む、インプラント。
(14)前記実施態様(13)記載のインプラントであって、前記ヤーンは、少なくとも2本のフィラメントを含む、インプラント。
(15)前記実施態様(11)記載のインプラントであって、前記繊維は、メッシュを構成する、インプラント。
(17)前記実施態様(11)記載のインプラントであって、前記繊維は、外科用縫合糸を構成する、インプラント。
(18)前記実施態様(11)記載のインプラントであって、前記繊維は、ウィーブを構成する、インプラント。
(19)前記実施態様(11)記載のインプラントであって、前記繊維は、ニットを構成する、インプラント。
(20)前記実施態様(11)記載のインプラントであって、前記繊維は、不織布を構成する、インプラント。
(22)前記実施態様(16)記載のインプラントであって、前記編組は、モノフィラメントから成る、インプラント。
(23)前記実施態様(12)記載のインプラントであって、前記モノフィラメントの直径は、約50〜約200ミクロンである、インプラント。
(24)前記実施態様(15)記載のインプラントであって、前記メッシュのメッシュ密度は、約20%〜約88%である、インプラント。
(25)前記実施態様(15)記載のインプラントであって、前記メッシュのメッシュ密度は、約20%〜約55%である、インプラント。
(27)前記実施態様(1)記載のインプラントであって、前記ポリマー補強部材は、脂肪族ポリエステル、ポリ(アルファ−オキシ酸)、ポリ(アミノ酸)、ポリアルキレンオキサレート、ポリアミド、チロシン誘導ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、ポリラクチド並びにこれらのコポリマー及び配合物から成る群から選択されたポリマーから成る、インプラント。
(28)前記実施態様(1)記載のインプラントであって、ポリマー補強部材は、メッシュを含み、前記メッシュは、重合ラクチド及びグリコリドのコポリマーから成る、インプラント。
(29)前記実施態様(1)記載のインプラントであって、前記ポリマー補強部材は、メッシュを含み、前記メッシュは、95/5モルのポリ(ラクチド−コ−グリコリド)から成る、インプラント。
(30)前記実施態様(1)記載のインプラントであって、前記フォームは、連続気泡構造を有する、インプラント。
(32)前記実施態様(1)記載のインプラントであって、前記被膜は、ポリジオキサノン、ポリジオキサノンとL(−)−ラクチド、D(+)−ラクチド、メソ−ラクチドとのコポリマー、トリメチレンカーボネート、イプシロン−カプロラクトン、グリコリド又はこれらの組合せから成る群から選択されたポリマーから成り、ただし、重合ジオキサノンが少なくとも50重量パーセントであることを条件とする、インプラント。
(33)前記実施態様(1)記載のインプラントであって、前記被膜は、ポリ(p−ジオキサノン)から成る、インプラント。
(34)前記実施態様(1)記載のインプラントであって、前記被膜の前記厚さは、凍結乾燥溶剤が前記補強部材に接触するのを効果的に阻止するのに十分である、インプラント。
(35)前記実施態様(1)記載のインプラントであって、前記被膜の前記厚さは、約1.0ミル以上である、インプラント。
(37)前記実施態様(1)記載のインプラントであって、凍結乾燥溶剤は、p(ジオキサン)を含む、インプラント。
(38)生体適合性組織インプラントの製造方法であって、
凍結乾燥溶剤に溶かしたフォーム形成生体適合性ポリマーを含む溶液を用意する工程を有し、
前記凍結乾燥溶剤中に溶けるポリマーから成る生体適合性ポリマー補強部材及び前記部材に被着される厚さを有する生体適合性ポリマー被膜を用意する工程を有し、前記ポリマー被膜は、前記凍結乾燥溶剤中には実質的に溶けない被覆用ポリマーから成り、
ポリマー補強部材を適当な金型のキャビティ内に配置する工程を有し、
前記溶液を前記金型の前記キャビティに加えて前記キャビティの少なくとも一部が前記溶液で満たされ、前記補強部材の少なくとも一部が前記溶液と接触状態になるようにする工程を有し、
前記補強部材及び前記溶液を前記溶剤の前記凝固点を下回る温度まで冷却して凍結乾燥させる工程を有する、方法。
(39)前記実施態様(38)記載の方法であって、前記金型の前記キャビティ内の前記補強部材を特定の形態で差し向ける追加の工程を有する、方法。
(40)前記実施態様(38)記載の方法であって、前記補強部材は、前記金型の前記キャビティ内への配置に先立ってアニールされる、方法。
(42)前記実施態様(38)記載の方法であって、前記金型は、前記金型の前記キャビティ内への前記補強部材の配置に先立って、前記溶剤の前記凝固点を下回る温度まで冷却される、方法。
(43)前記実施態様(38)記載の方法であって、前記溶剤の前記フォーム形成ポリマーと反応しない固体が、前記溶液に添加される、方法。
(44)前記実施態様(43)記載の方法であって、前記固体は、鉱質消失骨、リン酸カルシウム、硫酸カルシウム、及び炭酸カルシウムから成る群から選択された粒子を含む、方法。
(45)前記実施態様(43)記載の方法であって、前記固体は、塩化ナトリウム、塩化カリウム、塩化カルシウム、酒石酸ナトリウム、クエン酸ナトリウム、グルコース、フルクトース、デキストロース、マルトース、ラクトース、スクロース、デンプン、アルギン酸塩、キトサン、ゼラチン及びアガロースから成る群から選択された物質を含む、方法。
(47)前記実施態様(43)記載の方法であって、前記固体は、ポリエチレン、ポリビニルアセテート、ポリエチレンオキシド、ポリメチルメタクリレート、シリコーン、ポリエチレングリコール、ポリウレタン、セルロース、キチン、ケラチン及び弗素化ポリマーから成る群から選択された物質を含む、方法。
(48)前記実施態様(38)記載の方法であって、前記ポリマーフォームは、生体吸収性ポリマーから成る、方法。
(49)前記実施態様(38)記載の方法であって、前記ポリマーフォームは、脂肪族ポリエステル、ポリ(アミノ酸)、ポリアルキレンオキサレート、ポリアミド、チロシン誘導ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル並びにこれらのコポリマー及び配合物から成る群から選択されたポリマーから成る、方法。
(50)前記実施態様(38)記載の方法であって、前記ポリマー補強部材は、生体吸収性ポリマーから成る、方法。
(52)前記実施態様(38)記載の方法であって、前記補強部材は、重合ラクチド及びグリコリドのコポリマーから成る、方法。
(53)前記実施態様(38)記載の方法であって、前記被膜は、ポリジオキサノン、ポリジオキサノンとL(−)−ラクチド、D(+)−ラクチド、メソ−ラクチドとのコポリマー、トリメチレンカーボネート、イプシロン−カプロラクトン、グリコリド又はこれらの組合せから成る群から選択されたポリマーから成り、ただし、重合ジオキサノンが少なくとも50重量パーセントであることを条件とする、方法。
(54)前記実施態様(38)記載の方法であって、前記被膜は、ポリ(p−ジオキサノン)から成る、方法。
(55)前記実施態様(38)記載の方法であって、前記被膜の前記厚さは、凍結乾燥溶剤が前記補強部材に接触するのを効果的に阻止するのに十分である、方法。
(57)前記実施態様(38)記載の方法であって、前記凍結乾燥溶剤は、p(ジオキサン)及びトリオキサンから成る群から選択される、方法。
(58)前記実施態様(38)記載の方法であって、凍結乾燥溶剤は、p(ジオキサン)を含む、方法。
(59)損傷した組織の修復方法であって、
凍結乾燥溶剤に溶ける生体適合性ポリマーフォームと、前記凍結乾燥溶剤に溶ける生体適合性ポリマー補強部材と、前記補強部材に被着される厚さを持つポリマー被膜とを有する生体適合性組織インプラントを用意する段階を有し、前記被膜は、被覆用ポリマーから成り、前記被覆用ポリマーは、前記凍結乾燥溶剤には実質的に溶けず、
前記インプラントを組織損傷部に対して相対的な部位で所望の位置に配置する段階を有する、方法。
(60)前記実施態様(59)記載の方法であって、前記インプラントは、組織損傷部を構成する病変部内に配置される、方法。
(62)前記実施態様(60)記載の方法であって、前記インプラントは、該インプラントが前記病変部の幾何学的形状及び寸法に一致するような寸法及び形状のものである、方法。
(63)前記実施態様(60)記載の方法であって、前記インプラントは、前記病変部内に締まり嵌め関係をなして配置される、方法。
(64)前記実施態様(59)記載の方法であって、前記インプラントは、該インプラントが前記組織を補強するよう裂離部を構成する病変部に隣接して配置される、方法。
(65)前記実施態様(59)記載の方法であって、前記インプラントは、病変部を有する組織に巻き付けられる、方法。
(67)前記実施態様(59)記載の方法であって、前記インプラントは、縫合により前記部位に取り付けられる、方法。
(68)前記実施態様(59)記載の方法であって、前記インプラントは、ステープル留めにより前記部位に取り付けられる、方法。
(69)前記実施態様(59)記載の方法であって、前記インプラントは、グルーを用いることにより前記部位に取り付けられる、方法。
(70)前記実施態様(59)記載の方法であって、前記インプラントは、縫合糸アンカー、組織タック、ダーツ、ねじ、矢及びこれらの組合せから成る群から選択された器具を用いて前記部位に取り付けられる、方法。
(72)前記実施態様(59)記載の方法であって、前記組織は、軟組織を含む、方法。
(73)前記実施態様(38)記載の方法であって、前記金型は、前記金型の前記キャビティ内への前記補強部材の配置に先立って、25℃を下回る温度に冷却され、前記溶液を、該溶液を前記金型の前記キャビティに加えるのに先立って、25℃を下回るが、前記溶液の凝固点よりも高い温度に予備冷蔵する、方法。
10 インプラント
12 ポリマーフォームコンポーネント
12a,12b フォームコンポーネント
13 細孔
14 補強部材
14a,14b 補強コンポーネント
18 頂面
20 底面
Claims (59)
- 組織インプラントであって、
生体適合性ポリマーフォームを有し、前記フォームは、凍結乾燥溶剤に溶け、
生体適合性ポリマー補強部材を有し、前記補強部材は、前記凍結乾燥溶剤に溶け、
前記補強部材に被着される厚さを持つポリマー被膜を有し、前記被膜は、被覆用ポリマーから成り、前記被覆用ポリマーは、前記凍結乾燥溶剤には実質的に溶けない、組織インプラント。 - 請求項1記載のインプラントであって、前記ポリマーフォームは、生体吸収性である、インプラント。
- 請求項1記載のインプラントであって、前記ポリマーフォームは、脂肪族ポリエステル、ポリ(アミノ酸)、ポリアルキレンオキサレート、ポリアミド、チロシン誘導ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル並びにこれらのコポリマー及び配合物から成る群から選択されたポリマーから成る、インプラント。
- 請求項1記載のインプラントであって、ポリマーフォームは、モル比が約70/30〜約55/45のポリ(ラクチド−コ−カプロラクトン)を含む、インプラント。
- 請求項1記載のインプラントであって、前記ポリマーフォームは、モル比が約60/40のポリ(ラクチド−コ−カプロラクトン)を含む、インプラント。
- 請求項1記載のインプラントであって、前記ポリマーフォームは、モル比が35/65〜65/35のポリ(グリコリド−コ−カプロラクトン)を含む、インプラント。
- 請求項1記載のインプラントであって、前記ポリマーフォームは、モル比が約65/35のポリ(グリコリド−コ−カプロラクトン)を含む、インプラント。
- 請求項1記載のインプラントであって、前記ポリマーフォームは、モル比が約60/40のポリ(ラクチド−コ−カプロラクトン)とモル比が約65/35のポリ(グリコリド−コ−カプロラクトン)の配合物を含む、インプラント。
- 請求項1記載のインプラントであって、前記ポリマー補強部材は、複数個の粒子を含む、インプラント。
- 請求項1記載のインプラントであって、前記ポリマー補強部材は、少なくとも1枚のシートを含む、インプラント。
- 請求項1記載のインプラントであって、前記ポリマー補強部材は、少なくとも1本の繊維を含む、インプラント。
- 請求項11記載のインプラントであって、前記繊維は、モノフィラメントを含む、インプラント。
- 請求項11記載のインプラントであって、前記繊維は、マルチフィラメントヤーンを含む、インプラント。
- 請求項13記載のインプラントであって、前記ヤーンは、少なくとも2本のフィラメントを含む、インプラント。
- 請求項11記載のインプラントであって、前記繊維は、メッシュを構成する、インプラント。
- 請求項11記載のインプラントであって、前記繊維は、編組を構成する、インプラント。
- 請求項11記載のインプラントであって、前記繊維は、外科用縫合糸を構成する、インプラント。
- 請求項11記載のインプラントであって、前記繊維は、ウィーブを構成する、インプラント。
- 請求項11記載のインプラントであって、前記繊維は、ニットを構成する、インプラント。
- 請求項11記載のインプラントであって、前記繊維は、不織布を構成する、インプラント。
- 請求項15記載のインプラントであって、前記メッシュは、モノフィラメントから成る、インプラント。
- 請求項16記載のインプラントであって、前記編組は、モノフィラメントから成る、インプラント。
- 請求項12記載のインプラントであって、前記モノフィラメントの直径は、約50〜約200ミクロンである、インプラント。
- 請求項15記載のインプラントであって、前記メッシュのメッシュ密度は、約20%〜約88%である、インプラント。
- 請求項15記載のインプラントであって、前記メッシュのメッシュ密度は、約20%〜約55%である、インプラント。
- 請求項1記載のインプラントであって、前記ポリマー補強部材は、生体吸収性ポリマーから成る、インプラント。
- 請求項1記載のインプラントであって、前記ポリマー補強部材は、脂肪族ポリエステル、ポリ(アルファ−オキシ酸)、ポリ(アミノ酸)、ポリアルキレンオキサレート、ポリアミド、チロシン誘導ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、ポリラクチド並びにこれらのコポリマー及び配合物から成る群から選択されたポリマーから成る、インプラント。
- 請求項1記載のインプラントであって、ポリマー補強部材は、メッシュを含み、前記メッシュは、重合ラクチド及びグリコリドのコポリマーから成る、インプラント。
- 請求項1記載のインプラントであって、前記ポリマー補強部材は、メッシュを含み、前記メッシュは、95/5モルのポリ(ラクチド−コ−グリコリド)から成る、インプラント。
- 請求項1記載のインプラントであって、前記フォームは、連続気泡構造を有する、インプラント。
- 請求項1記載のインプラントであって、前記フォームは、独立気泡構造を有する、インプラント。
- 請求項1記載のインプラントであって、前記被膜は、ポリジオキサノン、ポリジオキサノンとL(−)−ラクチド、D(+)−ラクチド、メソ−ラクチドとのコポリマー、トリメチレンカーボネート、イプシロン−カプロラクトン、グリコリド又はこれらの組合せから成る群から選択されたポリマーから成り、ただし、重合ジオキサノンが少なくとも50重量パーセントであることを条件とする、インプラント。
- 請求項1記載のインプラントであって、前記被膜は、ポリ(p−ジオキサノン)から成る、インプラント。
- 請求項1記載のインプラントであって、前記被膜の前記厚さは、凍結乾燥溶剤が前記補強部材に接触するのを効果的に阻止するのに十分である、インプラント。
- 請求項1記載のインプラントであって、前記被膜の前記厚さは、約1.0ミル以上である、インプラント。
- 請求項1記載のインプラントであって、前記凍結乾燥溶剤は、p(ジオキサン)及びトリオキサンから成る群から選択される、インプラント。
- 請求項1記載のインプラントであって、凍結乾燥溶剤は、p(ジオキサン)を含む、インプラント。
- 生体適合性組織インプラントの製造方法であって、
凍結乾燥溶剤に溶かしたフォーム形成生体適合性ポリマーを含む溶液を用意する工程を有し、
前記凍結乾燥溶剤中に溶けるポリマーから成る生体適合性ポリマー補強部材及び前記部材に被着される厚さを有する生体適合性ポリマー被膜を用意する工程を有し、前記ポリマー被膜は、前記凍結乾燥溶剤中には実質的に溶けない被覆用ポリマーから成り、
ポリマー補強部材を適当な金型のキャビティ内に配置する工程を有し、
前記溶液を前記金型の前記キャビティに加えて前記キャビティの少なくとも一部が前記溶液で満たされ、前記補強部材の少なくとも一部が前記溶液と接触状態になるようにする工程を有し、
前記補強部材及び前記溶液を前記溶剤の前記凝固点を下回る温度まで冷却して凍結乾燥させる工程を有する、方法。 - 請求項38記載の方法であって、前記金型の前記キャビティ内の前記補強部材を特定の形態で差し向ける追加の工程を有する、方法。
- 請求項38記載の方法であって、前記補強部材は、前記金型の前記キャビティ内への配置に先立ってアニールされる、方法。
- 請求項38記載の方法であって、前記補強部材は、前記金型の前記キャビティ内への配置に先立って張力下に置かれる、方法。
- 請求項38記載の方法であって、前記金型は、前記金型の前記キャビティ内への前記補強部材の配置に先立って、前記溶剤の前記凝固点を下回る温度まで冷却される、方法。
- 請求項38記載の方法であって、前記溶剤の前記フォーム形成ポリマーと反応しない固体が、前記溶液に添加される、方法。
- 請求項43記載の方法であって、前記固体は、鉱質消失骨、リン酸カルシウム、硫酸カルシウム、及び炭酸カルシウムから成る群から選択された粒子を含む、方法。
- 請求項43記載の方法であって、前記固体は、塩化ナトリウム、塩化カリウム、塩化カルシウム、酒石酸ナトリウム、クエン酸ナトリウム、グルコース、フルクトース、デキストロース、マルトース、ラクトース、スクロース、デンプン、アルギン酸塩、キトサン、ゼラチン及びアガロースから成る群から選択された物質を含む、方法。
- 請求項43記載の方法であって、前記固体は、ステンレス鋼、コバルトクロム、チタン、チタン合金、アルミナ及びジルコニアから成る群から選択された物質を含む、方法。
- 請求項43記載の方法であって、前記固体は、ポリエチレン、ポリビニルアセテート、ポリエチレンオキシド、ポリメチルメタクリレート、シリコーン、ポリエチレングリコール、ポリウレタン、セルロース、キチン、ケラチン及び弗素化ポリマーから成る群から選択された物質を含む、方法。
- 請求項38記載の方法であって、前記ポリマーフォームは、生体吸収性ポリマーから成る、方法。
- 請求項38記載の方法であって、前記ポリマーフォームは、脂肪族ポリエステル、ポリ(アミノ酸)、ポリアルキレンオキサレート、ポリアミド、チロシン誘導ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル並びにこれらのコポリマー及び配合物から成る群から選択されたポリマーから成る、方法。
ント。 - 請求項38記載の方法であって、前記ポリマー補強部材は、生体吸収性ポリマーから成る、方法。
- 請求項38記載の方法であって、前記補強部材は、脂肪族ポリエステル、ポリ(アルファ−オキシ酸)、ポリ(アミノ酸)、ポリアルキレンオキサレート、ポリアミド、チロシン誘導ポリカーボネート、ポリオルトエステル、ポリオキサエステル、ポリアミドエステル、ポリラクチド並びにこれらのコポリマー及び配合物から成る群から選択されたポリマーから成る、方法。
- 請求項38記載の方法であって、前記補強部材は、重合ラクチド及びグリコリドのコポリマーから成る、方法。
- 請求項38記載の方法であって、前記被膜は、ポリジオキサノン、ポリジオキサノンとL(−)−ラクチド、D(+)−ラクチド、メソ−ラクチドとのコポリマー、トリメチレンカーボネート、イプシロン−カプロラクトン、グリコリド又はこれらの組合せから成る群から選択されたポリマーから成り、ただし、重合ジオキサノンが少なくとも50重量パーセントであることを条件とする、方法。
- 請求項38記載の方法であって、前記被膜は、ポリ(p−ジオキサノン)から成る、方法。
- 請求項38記載の方法であって、前記被膜の前記厚さは、凍結乾燥溶剤が前記補強部材に接触するのを効果的に阻止するのに十分である、方法。
- 請求項38記載の方法であって、前記被膜の前記厚さは、約1.0ミル以上である、方法。
- 請求項38記載の方法であって、前記凍結乾燥溶剤は、p(ジオキサン)及びトリオキサンから成る群から選択される、方法。
- 請求項38記載の方法であって、凍結乾燥溶剤は、p(ジオキサン)を含む、方法。
- 損傷した組織の修復方法であって、
凍結乾燥溶剤に溶ける生体適合性ポリマーフォームと、前記凍結乾燥溶剤に溶ける生体適合性ポリマー補強部材と、前記補強部材に被着される厚さを持つポリマー被膜とを有する生体適合性組織インプラントを用意する段階を有し、前記被膜は、被覆用ポリマーから成り、前記被覆用ポリマーは、前記凍結乾燥溶剤には実質的に溶けず、
前記インプラントを組織損傷部に対して相対的な部位で所望の位置に配置する段階を有する、方法。
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US10/955,370 US8197837B2 (en) | 2003-03-07 | 2004-09-30 | Method of preparation of bioabsorbable porous reinforced tissue implants and implants thereof |
US10/955,370 | 2004-09-30 |
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JP2010536397A (ja) * | 2007-03-23 | 2010-12-02 | スミス アンド ネフュー インコーポレーテッド | 固定器具および修復方法 |
JP2012517319A (ja) * | 2009-02-11 | 2012-08-02 | ナンヤン テクノロジカル ユニヴァーシティ | 多層外科的プロテーゼ |
JP2015147098A (ja) * | 2009-02-11 | 2015-08-20 | ナンヤン テクノロジカル ユニヴァーシティNanyang Technological University | 多層外科的プロテーゼ |
US9486302B2 (en) | 2009-02-11 | 2016-11-08 | Nanyang Technological University | Multi-layered surgical prosthesis |
JP2011072797A (ja) * | 2009-10-01 | 2011-04-14 | Tyco Healthcare Group Lp | メッシュインプラント |
JP2017533776A (ja) * | 2014-11-13 | 2017-11-16 | アントニオ・サンブッセティAntonio SAMBUSSETI | 回旋筋腱板の再構成のための弾性デバイス |
Also Published As
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US20050113938A1 (en) | 2005-05-26 |
DE602005004977D1 (de) | 2008-04-10 |
US8895045B2 (en) | 2014-11-25 |
EP1645298A1 (en) | 2006-04-12 |
US20130123937A1 (en) | 2013-05-16 |
CA2521355A1 (en) | 2006-03-30 |
AU2005205829B2 (en) | 2011-04-07 |
AU2005205829A1 (en) | 2006-04-13 |
EP1645298B2 (en) | 2017-03-15 |
CA2521355C (en) | 2014-11-25 |
US8197837B2 (en) | 2012-06-12 |
DE602005004977T3 (de) | 2017-06-01 |
EP1645298B1 (en) | 2008-02-27 |
DE602005004977T2 (de) | 2009-02-26 |
JP5430818B2 (ja) | 2014-03-05 |
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