JP2022519388A - 骨修復における固定を増強するための脱灰骨線維インプラント構成物及び方法 - Google Patents
骨修復における固定を増強するための脱灰骨線維インプラント構成物及び方法 Download PDFInfo
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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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Abstract
Description
[0002] 本発明の分野は、骨修復のために腱を増強するために、皮質骨から作製された骨線維インプラントであって、複数の脱灰骨線維(demineralized bone fibers)が、ペグ部分及びシート部分を有する形状を形成している、骨線維インプラントの構成物(composition)及び方法に関する。
[0003] 背景の説明は、本開示を理解するのに有用とし得る情報を含む。本明細書で提供されるいずれの情報も、従来技術であるか、若しくは現在特許請求されている発明に関連すること、又は具体的若しくは黙示的に言及されたいずれの刊行物も従来技術であることを承認するものではない。
[0011] 本発明人らは、好都合なことに、例えば、脱灰骨の複数の線維(すなわち、脱灰骨線維(DBF:demineralized bone fibers)、コラーゲンすなわち膠原線維、合成ポリマー、再吸収性線維)で構成されかつ適切な形状に形成され得るインプラントの使用によって、骨へのインプラント及び組織の固定を高める構成物及び方法を発見した。本発明のいくつかの実施形態によるインプラントは、i)組織と骨との間の境界面に配置され得るか、又はii)スクリュー挿入前に骨の穴内に配置され得る。
[0033] 特許又は特許出願は、カラーで示された少なくとも1つの図面を含む。カラーの図面の本特許又は特許出願公開の写しは、要請しかつ必要料金を支払うと、特許庁によって提供される。
[0073] 本発明の実施形態の態様は、脱灰骨線維(DBF)、コラーゲン、ポリマー、及び/又は再吸収性ポリマー線維のインプラントを使用して、骨の修復及び治癒を増強するためのアプローチに関する。
[00132] 所望の形状又は形態の線維を生じるための、脱灰骨線維、合成ポリマー線維、膠原線維、又は再吸収性ポリマー線維の処理は、任意の好適な方法を使用して実施され得る。特異的に脱灰された骨線維の処理は、本明細書で開示するような任意の好適な方法を使用して実施され得る。これらの形態のうちのいくつかを作製するために、骨線維は、理想的にはそれらの水和状態で、集められ、かつ圧力型を使用して圧縮され得、圧力は、求められる形状を形成するのに十分であるが、線維構造の多孔性を失うほど高くはない。いくつかの実施形態では、骨線維は、不織製造又は製紙の当業者にはよく理解されているように、湿式堆積(wet lay)技術を使用して形成される。湿式堆積技術を使用して、切断された骨線維は、水溶液中に懸濁されて骨線維スラリーを形成する。任意の好適な生体適合性水溶液が使用され得る。生体適合性水溶液の非限定的な例は:水、食塩水、及び/又はリン酸緩衝食塩水(PBS)などの塩を含む溶液、リンガー溶液、乳酸加リンガー溶液、及びデキストロース5%の食塩水を含む。本発明のいくつかの実施形態では、切断された線維は、食塩水内に入れられて、骨線維が絡み合ったスラリーを生じる。骨線維スラリーは、メッシュスクリーン(孔が設けられている)上に浮遊させられ、食塩水が排出されて、湿式堆積プロセスを生じ、脱灰骨線維のシートがメッシュスクリーン上に形成されるようにする。スクリーンは、スクリーンに三次元形状を与えるように曲線を付けて作られて、シリンダー状ペレットが直接作られ得るか、又はシートが作られるように平坦である。その後、結果として生じるデバイスは、加熱及び/又は真空又は凍結乾燥(フリーズドライ)などの他の手段を使用して乾燥され得る。いくつかの実施形態では、乾燥前、シートは、型内に配置され、かつ規定の厚さ及び形状へと圧縮されて、その後乾燥される。本明細書で説明するように、結果として生じる製品の密度、多孔性及び全体寸法は、様々な型及び技術を使用して制御され得る。
[00163] 添加剤は、本発明の実施形態によるインプラントの生物学的特性又は他の特性を変えるために考慮される。添加剤の非限定的な例は、増殖因子、例えば骨形成タンパク質(BMPs:bone morphogenetic proteins)、例えばBMP-1、BMP-2、BMP-3、BMP-4、BMP-5、BMP-6、BMP-7、BMP-8、BMP-9、BMP-10、BMP-11、BMP-12、BMP-13、BMP-15、BMP-16、BMP-17、及びBMP-18;血管内皮増殖因子(VEGFs:Vascular Endothelial Growth Factors)、例えばVEGF-A、VEGF-B、VEGF-C、VEGF-D及びVEGF-E;結合組織増殖因子(CTGFs:Connective Tissue Growth Factors)、例えばCTGF-1、CTGF-2、及びCTGF-3;オステオプロテゲリン(Osteoprotegerin)、形質転換増殖因子β(TGF-βαs:Transforming Growth Factor betas)、例えばTGF-β-1、TGF-β-2、及びTGF-β-3、及び腫瘍壊死因子の阻害物質(例えば、抗TNF-α)を含む。モルフォゲンはまた、米国特許第6,630,153号(その内容全体を本願明細書に援用する)に開示されているように、血小板由来増殖因子(PDGFs:Platelet Derived Growth Factors)、例えばPDGF-A、PDGF-B、PDGF-C、PDGF-D、及びGDF-5;rhGDF-5;及びLIM石灰化タンパク質(LIM mineralization protein)、インスリン関連の増殖因子-I(IGF-I)、インスリン関連の増殖因子-II(IGF-II)、線維芽細胞増殖因子(FGF:fibroblast growth factor)及びβ-2-ミクログロブリン(BDGF II)を含み得る。それらをコード化するポリヌクレオチドも、遺伝子治療作用物質として投与され得る。好ましい生物活性物質は、遺伝子組み換えヒト骨形成タンパク質(rhBMPs:recombinant human bone morphogenetic proteins)であり、なぜなら、それらは比較的無制限の供給で入手可能であり、かつ感染症をうつさないためである。いくつかの実施形態では、骨形成タンパク質は、rhBMP-2、rhBMP-4、rhBMP-7、又はそれらのヘテロダイマーである。BMPは、Wyeth(Madison、N.J.)から入手可能であり、かつまた当業者によって、Wozney et al.への米国特許第5,366,875号;Wang et al.への米国特許第4,877,864号;Wang et al.への米国特許第5,108,922号;Wang et al.への米国特許第5,116,738号;Wang et al.への米国特許第5,013,649号;Wozney et al.への米国特許第5,106,748号;及びWozney et al.へのPCT特許出願、国際公開第93/00432号;Celeste et al.への国際公開第94/26893号;及びCeleste et al.への国際公開第94/26892号(それらの内容全体を参照することにより本書に援用する)に説明されているように、準備され得る。
[00175] 以下の実施例は、ヒト皮質骨を使用している。本明細書で説明するように、ヒト又は動物のいずれかの骨が、皮質骨源として使用され得る。線維は、米国特許第9,486,557号及び米国特許第9,572,912号(上記)に説明されているような手法を使用して生産された。
[00176] 1mlの使い捨てのプラスチック製シリンジを型として使用した。プランジャーを取り外し、かつ0.25グラムのDBFをシリンジの端部に導入して、プランジャーを使用して、線維を約4cmの長さに軽く圧縮した。プランジャーを取り外し、シリンジの先端を、メスを使用して切り落とした。インプラントを27℃で一晩真空乾燥した。結果として得られたインプラントは、直径約4.5mmであった。
[00177] 実施例1からの3つのインプラントを、スクリュー引き抜き増強の試験に使用した。骨減少性の骨の代用物としてスクリュー引き抜きを試験するためにしばしば使用される、Sawbonesの1インチ当たり10個の細孔の発泡体を、使用した。発泡体ブロックに、直径5mmの穴を6個、ドリルで開けた。実施例1からのインプラントを、それら穴のうちの3つに入れた。5.5mmの椎弓根スクリューを6個の穴に挿入した。MTS引張試験機を、スクリューを穴から引き抜くために必要な力を記録するために使用した。得られたデータを下記の表1に示す。
[00179] 15グラムのDBF線維を、10cm×11cmの平型に湿式堆積させて、DBFのシートを生産した。型を55℃に2時間加熱して、線維を結合させ、かつシートを乾燥させた。シートは厚さ約1mmである。シートの一部分は、ACL又は回旋筋腱板固定の増強に使用するのに好適である。
[00180] 実施例3のシートの一部分を、膝関節形成術からの脛骨トレイの形状に切断し、水和させ、かつ多孔質のコーティングされた脛骨トレイの表面上へと押しつけた。
[00181] 約3cm×1cmの実施例3のシートの部分を水和させ、かつ6mm直径の椎弓根スクリューのねじ部分に巻き付けた。DBFは、スクリューの表面に順応した。
[00182] ウォーターアシスト射出成形(WAIM:water assisted injection molding)を使用してインプラントを作製するための装置を、図16に示す概略図に従って製作した。遠位端部が除去された20mlシリンジを、3Dプリントしたアダプターに入れた。3つの切り離し可能な型サイズを使用し、それぞれのサイズは、長さ5cmであり、直径が:3.5mmから3mmに減少した;4.5mmから4mmに減少した;及び5.5mmから4.5mmに減少した。DBFを20mlシリンジに入れ、かつシリンジをPBSで満たした。シリンジの端部を、アダプター内に配置し、かつプランジャーを下方に押して、DBFを型に射出した。使用されるDBF量は、それぞれ3.5、4.5及び5.5mmの直径で0.45グラム、0.6グラム及び1.05グラムであった。成形後、型を真空オーブンに入れ、かつ真空下で、0.5L/分の空気の流れで、一晩、乾燥させた。エンドキャップの除去後、乾燥したインプラントを、単に、型から押し出すことによって、除去できた。インプラントの直径は、型の直径よりも直径が約0.75mm小さかった。
[00183] 実施例3からのシートの一部分を、図25aに示すようにスロットが切り込まれている、それぞれ2cm×5cmの2片に切断した。その後、シートを再水和させ、かつ4個の3mm直径のロッドを使用して、図27aの十字形を形成した。乾燥後のインプラントが図27bに示される。このインプラントは、acl移植片の固定の増強に使用するのに好適であった。
[00184] 実施例3からのシートの一部分を、約2cm×5cmの一片に切断した。その後、シートを再水和させ、かつ2つの3mm直径のロッドを使用して付形してから、再び乾燥させた。図27cのインプラントを形成した。このインプラントは、2ストランドacl移植片の固定の増強に使用するのに好適であった。
Claims (32)
- 骨修復用のインプラントを含む構成物であって、
前記インプラントは、
シリンダー、チューブ、カニューレ付きシリンダー、円錐台、カニューレ付き円錐台、フレア付き端部のある円錐台若しくはフレア付き端部のあるカニューレ付き円錐台、フレア付き端部のあるチューブ、又は円錐台形の形状を形成する複数の線維
を含む、構成物。 - 前記インプラントは近位端部及び遠位端部を有し、
前記複数の線維は、フレア付き端部のある円錐台、フレア付き端部のあるチューブ、又はフレア付き端部のあるカニューレ付き円錐台の前記形状を形成し、及び
前記フレア付き端部は前記インプラントの前記近位端部にある、請求項1に記載の構成物。 - 前記インプラントの長さは1cm~10cmである、請求項1又は2に記載の構成物。
- 前記インプラントの長さは4~5cmである、請求項1~3のいずれか1項に記載の構成物。
- 前記インプラントの体積は0.15cm3~10cm3である、請求項1~4のいずれか1項に記載の構成物。
- 前記フレア付き端部は、骨スクリューを受け入れるための刻み目を含む、請求項1~5のいずれか1項に記載の構成物。
- 前記インプラントは脱水された状態である、請求項1~6のいずれか1項に記載の構成物。
- 前記複数の線維は、脱灰骨、コラーゲン、生体適合性ポリマー、及び再吸収性ポリマーの少なくとも1つから作製された線維を含む、請求項1~7のいずれか1項に記載の構成物。
- 前記複数の線維は脱灰骨線維を含む、請求項8に記載の構成物。
- 前記再吸収性ポリマーはポリエステルである、請求項8に記載の構成物。
- 前記複数の線維は、過酸化カルシウム、アスコルビン酸カルシウム、硫酸カルシウム、リン酸カルシウム、炭酸カルシウム、塩化カルシウム、及びそれらの混合物でコーティングされている、請求項8に記載の構成物。
- 請求項1~11のいずれか1項に記載のインプラントを用いて、骨内でのスクリューの固定を強くするための方法であって、
任意選択的に、前記骨内での前記スクリューの位置を定めるためにガイドワイヤを配置することと、
前記骨の空洞に前記インプラントを挿入又は導入することと、
前記インプラントに前記スクリューを挿入又は導入することと、
を含む、方法。 - 前記ガイドワイヤが使用されるとき、前記インプラントの導入は、前記インプラントを、前記カニューレ付き、チューブ状、又は円錐形の前記インプラントの中を通る前記ガイドワイヤ上に置き、かつ前記インプラントを前記ガイドワイヤに沿って前記空洞内へと動かすことを含む、請求項12に記載の方法。
- 前記ガイドワイヤに沿って前記インプラントを動かすことは、錐、押子、タップ、及びドリルの少なくとも1つを使用することを含む、請求項12又は13に記載の方法。
- 前記骨内の前記空洞は、錐、押子、タップ、及びドリルの少なくとも1つを使用して形成される、請求項12~14のいずれか1項に記載の方法。
- 前記骨内の前記空洞は、錐又はタップを使用して形成され、骨の除去を防止し、かつ前記スクリューの固定を補強するための圧縮を生じる、請求項12~15のいずれか1項に記載の方法。
- 前記インプラントは脱灰骨線維(DBF)を含む、請求項12~16のいずれか1項に記載の方法。
- 請求項1~11のいずれか1項に記載のインプラントを用いる、骨内でのスクリューの固定を増強するための方法であって、
前記骨内での前記スクリューの位置を定めるためにガイドワイヤを配置することと、
前記骨の空洞に前記インプラントを挿入又は導入することと、
前記インプラントに前記スクリューを挿入又は導入することと、
を含む、方法。 - 前記インプラント又は前記スクリューを前記挿入又は導入することは、カニューレ付き器具を使用することを含む、請求項18に記載の方法。
- 前記インプラントを前記挿入又は導入することは、前記インプラントを含む開口シリンジを使用することを含む、請求項18に記載の方法。
- 前記インプラントは脱灰骨線維(DBF)を含む、請求項18~20のいずれか1項に記載の方法。
- 前記インプラントは骨誘導インプラント又は骨伝導インプラントである、請求項18~21のいずれか1項に記載の方法。
- 請求項1~11のいずれか1項に記載のインプラントを製作する方法であって、
流体中に前記複数の線維を分散させることであって、
前記複数の線維及び前記流体は、約1グラムの線維に対して約3ml~50mlの前記流体の割合にあることと、
ベント付きの型内へと、前記分散された前記複数の線維を圧入し、前記型から前記流体を排出させることと、
を含む、方法。 - 前記複数の線維及び前記流体は、約1グラムの線維に対して約3ml~20mlの前記流体の割合にある、請求項23に記載の方法。
- 前記型内で前記複数の線維を加熱することさらにを含む、請求項23又は24に記載の方法。
- 前記加熱することは、約35~55℃で行われる、請求項23~25のいずれか1項に記載の方法。
- 前記線維は凍結乾燥される、請求項23~26のいずれか1項に記載の方法。
- 前記複数の線維は、脱灰骨、コラーゲン、生体適合性ポリマー、及び再吸収性ポリマーの少なくとも1つで作製された線維を含む、請求項23~27のいずれか1項に記載の方法。
- 前記複数の線維は、脱灰骨製の線維を含む、請求項28に記載の方法。
- インプラントを用いて骨内でのスクリューの固定を増強するためのキットであって、
請求項1~11のいずれか1項に記載のインプラント、
を含む、キット。 - ガイドワイヤと、
錐又はタップと、
修復されるべき前記骨内に配置されるべきスクリューのうち少なくとも1つ、
を含む、請求項30に記載のキット。 - 前記ガイドワイヤ及び前記錐又は前記タップは使い捨て可能である、請求項31に記載のキット。
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US62/901,935 | 2019-09-18 | ||
PCT/US2020/017369 WO2020163828A1 (en) | 2019-02-09 | 2020-02-07 | Demineralized bone fiber implant compositions and methods for augmenting fixation in bone repair |
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US5403348A (en) * | 1993-05-14 | 1995-04-04 | Bonutti; Peter M. | Suture anchor |
US5948002A (en) * | 1996-11-15 | 1999-09-07 | Bonutti; Peter M. | Apparatus and method for use in positioning a suture anchor |
US5984926A (en) * | 1998-02-24 | 1999-11-16 | Jones; A. Alexander M. | Bone screw shimming and bone graft containment system and method |
DE69931018T2 (de) * | 1998-12-30 | 2006-11-23 | Ethicon, Inc. | Fadensicherungsgerät |
US6193516B1 (en) | 1999-06-18 | 2001-02-27 | Sulzer Calcitek Inc. | Dental implant having a force distribution shell to reduce stress shielding |
US9387094B2 (en) * | 2000-07-19 | 2016-07-12 | Warsaw Orthopedic, Inc. | Osteoimplant and method of making same |
WO2006020994A2 (en) * | 2004-08-13 | 2006-02-23 | Angiotech International Ag | Compositions and methods using hyaluronic acid and hyluronidase inhibitors |
US7806911B2 (en) * | 2006-04-14 | 2010-10-05 | Warsaw Orthopedic, Inc. | Fixation plate and method of use |
GB0608345D0 (en) * | 2006-04-27 | 2006-06-07 | Univ Warwick | Implant |
US8663326B2 (en) | 2007-12-13 | 2014-03-04 | Said G. Osman | Biologic artificial bone |
US9757213B2 (en) * | 2010-12-03 | 2017-09-12 | Ohio State Innovation Foundation | Hybrid dental implant |
ES2846818T3 (es) * | 2011-05-10 | 2021-07-29 | Peter Nordin | Tope para un implante dental |
US9913676B2 (en) * | 2014-11-14 | 2018-03-13 | Warsaw Orthopedic, Inc. | Milled bone graft materials and methods of use |
US11090411B2 (en) * | 2016-01-28 | 2021-08-17 | Warsaw Orthopedic, Inc. | Electron beam irradiated osteoinductive bone implant |
US20170312079A1 (en) * | 2016-04-28 | 2017-11-02 | Warsaw Orthopedic, Inc. | Mechanically entangled demineralized bone fibers |
US20180169295A1 (en) * | 2016-12-21 | 2018-06-21 | Industrial Technology Research Institute | Film, manufacturing method thereof, and use thereof |
US10639157B2 (en) * | 2017-03-14 | 2020-05-05 | Theracell, Inc. | Demineralized bone fiber composition for use in minimally invasive surgery |
US11116872B2 (en) * | 2018-08-17 | 2021-09-14 | Vivex Biologies Group, Inc. | Infused demineralized bone fibers |
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