JP6161042B2 - 脊椎椎体間融合に設計された無機物層被覆膜の分解性ケージ - Google Patents
脊椎椎体間融合に設計された無機物層被覆膜の分解性ケージ Download PDFInfo
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- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30899—Protrusions pierced with apertures
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- A—HUMAN NECESSITIES
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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
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2002/448—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants
- A61F2002/4485—Joints for the spine, e.g. vertebrae, spinal discs comprising multiple adjacent spinal implants within the same intervertebral space or within the same vertebra, e.g. comprising two adjacent spinal implants comprising three or more adjacent spinal implants
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- 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
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- A61F2310/00005—The prosthesis being constructed from a particular material
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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
- A61F2310/00005—The prosthesis being constructed from a particular material
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- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
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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
- A61F2310/00005—The prosthesis being constructed from a particular material
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- A61F2310/00029—Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
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- A—HUMAN NECESSITIES
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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
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00089—Zirconium or Zr-based alloys
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00113—Silver or Ag-based alloys
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00131—Tantalum or Ta-based alloys
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00149—Platinum or Pt-based alloys
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00155—Gold or Au-based alloys
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00179—Ceramics or ceramic-like structures
- A61F2310/00293—Ceramics or ceramic-like structures containing a phosphorus-containing compound, e.g. apatite
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00592—Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F2310/00796—Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/0097—Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
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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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00389—The prosthesis being coated or covered with a particular material
- A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF
Description
(参照)Cho et al.,"Preliminary experience using a polyetheretherketone (PEEK) cage in the treatment of cervical disc disease" Neurosurgery 52(3):693 2003 and Neurosurgery 51 :1343 2002、Parsons et al.,"Carbon fiber debris within the synovial joint. A time-dependent mechanical and histologic study", Clinical Orthopaedics & Related Research 1985:69-76
(参照)Andersson, "Epidemiological features of chronic low-back pain", Lancet 354:581-5, 19991995年には、約160,000の脊椎融合手術が行なわれた。
(参照)Praemer et al. "Musculoskeletal Conditions in the United States" Park Ridge: American Academy of Orthopaedic Surgeons, 19992000年の近況では、米国のみで、約360,000の患者が、幾つかの脊椎の関節固定術を受けている。
(参照)Sanhu, "Anterior lumbar interbody fusion with osteoinductive growth factors", Clinical Orthopaedics and Related Research 371 :56-60, 2000
ケージ素子の使用が、腰椎の変性疾患の椎体間融合の調整となっている。しかし、現在の金属ケージは、過剰な剛性が付随し、術後合併症の発生を増加する。例えば、応力遮蔽、ケージの移動又は損傷、偽関節、又は、合併副作用症候等がある。
(参照)van Dijk et al. "The effect of cage stiffness on the rate of lumbar interbody fusion: An in vivo model using poly(L-lactic acid) and titanium cages", Spine 27:682-8, 2002
金属ケージは、画像アーチファクトによる関節固定の見た目の評価及び脊柱管と神経孔の結合に干渉し得る。過剰な金属ケージの剛性に由来する応力遮蔽の環境は、ケージの内圧を低下する。
(参照)Kanayama et al., "In vitro biomechanical investigation of the stability and stress-shielding effect of lumbar interbody fusion devices", Journal of Neurosurgery 93:259-65, 2000
内圧低下は、無機質化の低下、骨の再吸収、長期に及ぶ著しい骨中無機質密度の減少に到る。
(参照)Cunningham et al., "A quantitative densitometric study investigating the stress- shielding effects of interbody spinal fusion devices: Emphasis on long-term fusions in thoroughbred racehorses", Trans Orthop Res Soc 23:250, 1998
(参照)Kandziora et al., "Biomechanical analysis of biodegradable interbody fusion cages augmented with poly(propylene glycol-co-fumaric acid)", Spine 27:1644-51 , 2002、Toth et al.,"Evaluation of 70/30 poly (L-lactide-co-D,L-lactide) for use as a resorbable interbody fusion cage", Journal of Neurosurgery 97:423-32, 2002、van Dijk et al., "Bioabsorbable poly-L-lactic acid cages for lumbar interbody fusion: three-year follow-up radiographic, histologic, and histomorphometric analysis in goats", Spine 27:2706-14, 2002、van Dijk et al., "Bioabsorbable poly-L-lactic acid cages for lumbar interbody fusion: three-year follow-up radiographic, histologic, and histomorphometric analysis in goats", Spine 27:2706-14, 2002
分解性ケージは、全ての異物を最終的に除去する非分解性材料に対し、多くの重要な利点を備えている。異物は、神経根の炎症、応力遮蔽効果の軽減を引き起こす。分解性ケージの利点は、隣接する椎間板疾患及び画像アーチファクトを低減する。然しながら、元の設計に基礎材料の単なる置換えは、適切な安定性の付与が出来ない。生分解性高分子は、恒久的な材料よりも剛性/強度に劣り、分解時間に妥協が必要となる。更に、このポリ(α−ヒドロキシ)酸の初期分解産物は、骨形成を阻害する低pH環境を形成する。少しのpHのずれでも、増殖及び分化の骨髄間質細胞(BMSC)機能に著しい影響を及ぼす。
(参照)Kohn et al., "Effects of pH on human bone marrow stromal cells in vitro: Implications for tissue engineering of bone", Journal of Biomedical Materials Research 60:292-9, 2002
骨芽細胞の成長及び発育が、細胞外の微細環境のpH及び酸性度の調節に関連している。
(参照)Chakkalakal et al., "Mineralization and pH relationships in healing skeletal defects grafted with demineralized bone matrix" Journal of Biomedical Materials Research 28:1439-43, 1994、Green "Cytosolic pH regulation in osteoblasts", Mineral and Electrolyte Metabolism 20:16-30, 1994、Kaysinger et al., "Extracellular pH modulates the activity of cultured human osteoblasts", Journal of Cellular Biochemistry 68:83-913-15, 1998
従って、分解性高分子ケージは、非分解性ケージに対し、顕著な潜在力の有る利点を提供するが、解決すべき重大な障害物がある。例えば、適切な機械的性質の維持及び分解産物の低減である。
(参照)Helm et al. "Bone graft substitutes for the promotion of spinal arthrodesis", Neurosurg Focus 10:1-5, 2000
幾つかの組み換えヒト骨形成タンパク(rh-BMP)を、特定の臨床応用に適用している。共通しているのは、吸収可能なコラーゲンスポンジを通して、骨誘導で関節固定を効果的に実行している。しかし、現在の送達方法は、骨再生に骨形成タンパクの直接的な送達が出来ない。
(参照)Bunker et al., "Ceramic thin film formation on functionalized interfaces through biomimetic processing", Science 264:48-55, 1994、Mann et al., "Crystallization and inorganic-organic interfaces - biominerals and biomimetic synthesis", Science 261:1286-92, 1993、Murphy et al., "Bioinspired growth of crystalline carbonate apatite on biodegradable polymer substrata", JAm Chem Soc 124:1910-7, 2002、Ohgushi et al., "Stem cell technology and bioceramics: from cell to gene engineering", J Biomed Mater Res 48:913-27, 1999
これら骨様の無機物被覆膜は、整形外科のインプラント材料の骨伝導能を著しく向上するのが分かっている。
(参照)Ohgushi et al. Hench, "Bioceramics: From concept to clinic", Journal of the American Ceramic Society 74:1487-510, 1991、Murphy et al., "Bone regeneration via a mineral substrate and induced angiogenesis", J Dent Res 83:204-10, 2004
これらの骨伝導能に加えて、無機物被覆膜は、骨形成成長因子を送達する運搬手段の可能性も示している。
(参照)Seeherman et al., "Bone morphogenetic protein delivery systems", Spine 27:S16-23, 2002
BMP-2、IGF-1及びTGF-βを含む多重骨成長因子が、骨様の無機物基板と強力に相互に作用することが判明した。
(参照)Gittens et al., "Imparting bone mineral affinity to osteogenic proteins through heparin-bisphosphonate conjugates", J Control Release 98:255-68, 2004、Gorski et al., "Is all bone the same? Distinctive distributions and properties of non-collagenous matrix proteins in lamellar vs. woven bone imply the existence of different underlying osteogenic mechanisms", Crit Rev Oral Biol Med 9:201-23, 1998、Gorski et al., "Bone acidic glycoprotein-75 is a major synthetic product of osteoblastic cells and localized as 75- and/or 50-kDa forms in mineralized ph
ases of bone and growth plate and in serum", J Biol Chem 265:14956-63, 1990、Liu et al., "Bone morphogenetic protein 2 incorporated into biomimetic coatings retains its biological activity", Tissue Eng 10:101-8, 2004、Matsumoto et al., "Hydroxyapatite particles as a controlled release carrier of protein", Biomaterials 25:3807-12, 2004、Sachse et al., "Osteointegration of hydroxyapatite-titanium implants coated with nonglycosylated recombinant human bone morphogenetic protein-2 (BMP-2) in aged sheep", Bone37:699-710, 2005
リン酸カルシウム無機物基板を成長因子で被覆し、次に、その因子が、足場構築に成長する骨形成細胞に提供される。従来の研究が示したのは、ヒドロキシアパタイト無機物を足場基板として使用し、骨成長因子(特に、BMP-2)の結合と放出を可能にすること、及び、結合した成長因子が、体内で内部成長を誘発することである。
(参照)Gittens et al.; and Sachse et al.
(1)生体適合性で生分解性高分子材料(例、ポリカプロラクトン)から形成する複数の相隔てた壁部又は設計された多孔性微細構造体と、
(2)一体化した板、釘又はスパイクを含む一体化固定突起部と、
(3)壁部の少なくとも一部分上の骨伝導性無機物被覆膜(例、カルシウム化合物)と、
(4)高分子及び/又は被覆膜に関連する生体活性剤と、を備えている。
生体活性剤は、隣接する椎体間の骨化を誘発する量で存在している。
る。係数は、選択した時間点での分解率に基づく重畳した材料密度に等しい元の材料の重量パーセントを示す。分解設計の最適の局地的/巨視的密度分布は、Xpw = ΣXptTwtEwtで取り込む。Xpwは、ベース材料の最終割合、Xptは、選択時点に対応する減少/分解率の一時的係数である。方法は、特定の分解期間後で所望の剛性を維持するように設計されたケージを作り出した。
(参照)Hollister et al. "Optimal design and fabrication of scaffolds to mimic tissue properties and satisfy biological constraints", Biomaterials 23:4095-103, 2002、Lin et al. "A novel method for internal architecture design to match bone elastic properties with desired porosity", Journal of Biomechanics 37:623-36, 2004
微視的又は2次スケールトポロジー最適化方法は、特定の微細構造体設計を与える。この設計は、所望の整合性を実践し、巨視的又は1次レベルトポロジー最適化の予測体積率に一致する。
(参照)Lin et al. "A novel method for internal architecture design to match bone elastic properties with desired porosity", Journal of Biomechanics 37:623-36, 2004、Murphy et al., "Bioinspired growth of crystalline carbonate apatite on biodegradable polymer substrata", J Am Chem Soc 124:1910-7, 2002、 Murphy et al., "Effects of a bone-like mineral film on phenotype of adult human mesenchymal stem cells in vitro", Biomaterials 26:303-10, 2005
図3,4は、リン酸カルシウムでポリカプロラクトンを被覆した結果を示す。図3は、ポリカプロラクトン足場の拡大した多孔構造の走査電子顕微鏡(SEM)写真で、リン酸カルシウムの非被覆膜(左側の右上)及びリン酸カルシウムの被覆膜(下側の右)を示す。図4は、ポリカプロラクトン(Λ)足場上に成長させたヒドロキシアパタイト(※)を示すX線回折スペクトルを示す。挿入図は、ポリカプロラクトン足場に成長させたリン酸カルシウム被覆膜の高倍率SEM画像である。従って、無機物被覆膜の成長に信頼できる方法として作用する。
(参照)Murphy et al., "Bioinspired growth of crystalline carbonate apatite on biodegradable polymer substrata", JAm Chem Soc 124:1910-7, 2002
ここで記載する測定方法は、無機物材料分析の慣例で、リン酸カルシウム被覆膜の設計及び検査のFDAガイド実施と一致する。
(参照)Devices FDoGaR. Calcium phosphate coating draft guidance for preparation of FDA submissions for orthopedic and dental endosseous implants. 1997
(参照)Murphy et al., "Bone regeneration via a mineral substrate and induced angiogenesis", J Dent Res 2004;83:204-10;、Murphy et al., "Growth of continuous bonelike mineral within porous poly(lactide-co-glycolide) scaffolds in vitro",. J Biomed Mater Res 50:50-8, 2000
無機物被覆膜をポリカプロラクトンケージ上に成長させ、1-100nMの125l-labeled BMP-2を含む溶液内で4時間定温放置する。Uludagグループによる以前の研究から、リン酸カルシウム被覆膜足場は、展開した可溶性のBMP-2内でBMP-2を50-100%効率で結合する。(参照)Gittens et al., "Imparting bone mineral affinity to osteogenic proteins through heparin- bisphosphonate conjugates", J Control Release 98:255-68, 2004
足場を溶液から除去し、無血清DMEMですすぎ洗いし、シンチレーション計数管で放射能を分析する。結合したBMP-2の次に続く放出の特性を調べる為に、試料を10%FBSのDMEM内で14日間定温放置した。24時間毎に、媒体を新鮮にし、溶液内の放射能を測定する。以前の研究に基づき、放出は、殆ど零次放出速度論で、溶液内で先ず7日間以上生じる。(参照)Gittens et al., "Imparting bone mineral affinity to osteogenic proteins through heparin-bisphosphonate conjugates", J Control Release 98:255-68, 2004
これらの実験は、足場からの幅広い全体のBMP-2の放出も立証している。放出されたタンパク質の全体量は、結合溶液(1-10OnM)に存在するBMP-2の量で支配される。BMP-2は、溶液内のヒドロキシアパタイトにイオン結合を形成すると予想される。特定のアミノ酸無機物結合断片が、BMP-2に組み込まれていると予想される。無機物結合断片は、溶液内のヒドロキシアパタイトにイオン結合を形成すると予想される。イオン結合は、リン酸カルシウム層の溶解又はポリカプロラクトンの分解を経て、骨形成タンパクの適切な制御された送達をもたらす。対照的に、スポンジ基BMP送達システムは、BMPのスポンジへの吸収に依存しており、送達制御が難しくなる。
(参照:Nakamura et al., "p38 mitogen-activated protein kinase functionally contributes to chondrogenesis induced by growth/differentiation factor-5 in ATDC5 cells", Exp Cell Res 250:351-63, 1999、Saito et al., "Activation of osteo-progenitor cells by a novel synthetic peptide derived from the bone morphogenetic protein-2 knuckle epitope", Biochim Biophys Acta 1651 :60-7, 2003、Saito et al., "Prolonged ectopic calcification induced by BMP-2-derived synthetic peptide", J Biomed Mater Res A 7OA: 115-21 , 2004
BMP-2によるマウス胚繊維芽細胞ラインC3H10T1/2の骨形成誘発は、十分に特性が知られている。従って、C3H10T1/2細胞基生物活性アッセイは、石化したポリカプロラクトン足場から放出される溶解性BMP-2の特性決定に使用される。無機物層から放出される0.1-1OOng/ml BMP-2に細胞を暴露し、リン酸アルカリの上方制御(BMP-2による骨形成誘発の目印)を、標準的な比色アッセイの使用で測定する。これらの結果を標準曲線と比較する。標準曲線は、可溶性のBMP-2濃度(足場から放出されない)を、アルカリホスホターゼ上方制御に関連させている。上方制御は、足場から放出されるBMP-2の有効な活性度を与える。放出されるBMP-2の活性は、無機物結合及び放出では実質的に影響されない。BMP-2は、生体内の通常の条件では、リン酸カルシウム無機物に強力に結合することが知られている。
(参照)Gorski et al., "Is all bone the same? Distinctive distributions and properties of non- collagenous matrix proteins in lamellar vs. woven bone imply the existence of different underlying osteogenic mechanisms", Crit Rev Oral Biol Med 9:201-23, 1998、Gorski et al., "Bone acidic glycoprotein-75 is a major synthetic product of osteoblastic cells and localized as 75- and/or 50-kDa forms in mineralized phases of bone and growth plate and in serum", J Biol Chem 265:14956-63, 1990
12,16,21,25,29,33 壁部
13,17,22,26,31,34 突起部
14,18,23,27 空隙
35 固定板
Claims (22)
- 隣接する骨又は隣接する骨表面の融合を促進するケージであって、前記ケージが、
上縁部分、底縁部分を有する中央部と
前記中央部の前記上縁部分と前記底縁部分との間から延在する第1高さ、前記中央部を横断する方向に延在する第1長さ、及び第1幅を有し、前記第1長さと前記第1高さが前記第1幅よりも大きい第1壁と、
前記中央部の前記上縁部分と前記底縁部分との間から延在する第2高さ、前記中央部を横断する方向に延在する第2長さ、及び第2幅を有し、前記第2長さと前記第2高さが前記第2幅よりも大きい第2壁と、
前記中央部の前記上縁部分と前記底縁部分との間から延在する第3高さ、前記中央部を横断する方向に延在する第3長さ、及び第3幅を有し、前記第3長さと前記第3高さが前記第3幅よりも大きく、前記第3幅だけ離れた第1側面及び第2側面を有し、前記第1壁と前記第2壁との間に位置付けられ、前記第1側面が前記第1壁に対面し、第2側面が前記第2壁に対面する第3壁と、を備え、
前記第1壁が前記中央部において以外は前記第2壁に連結されず、
前記中央部、前記第1壁、前記第2壁、及び前記第3壁が、多孔性微細構造体を含み、該多孔性微細構造体が、高分子材料、金属材料、セラミック材料及びそれらの混合物から選択される生体適合性材料を含み、
それぞれ異なる溶解特性を有する複数の層を含んでいる、前記多孔性微細構造体の少なくとも一部の上の骨伝導性無機物被覆膜と、
前記生体適合性材料及び前記被覆膜の少なくとも1つに関連し、前記隣接する骨の間又は隣接する骨表面の間に骨化を誘発する量で存在する生体活性剤と、
前記中央部から伸長する固定板と、をさらに備え、
前記第1壁、第2壁、及び第3壁の少なくとも2つが、前記上縁部分及び前記底縁部分の間の側面から、垂直に延在する突起を有している
ことを特徴とするケージ。 - 前記固定板が、前記第1壁、第2壁、及び第3壁の少なくとも1つに横断する方向に位置付けられていることを特徴とする請求項1記載のケージ。
- 前記骨伝導性無機物被覆膜が、複数の離散した無機物の島から構成されていることを特徴とする請求項1記載のケージ。
- 前記骨伝導性無機物被覆膜が、均質な無機物被覆膜で構成されていることを特徴とする請求項1記載のケージ。
- 前記生体活性剤が、骨形成タンパク、脱ミネラル骨母材、骨髄穿刺液、形質転換成長因子、繊維芽細胞成長因子、インシュリン様成長因子、血小板由来成長因子、血管内皮成長因子、成長分化因子-5、多血小板血漿、及び、それらの混合物から選択されることを特徴とする請求項1記載のケージ。
- 前記生体活性剤が、骨形成タンパクから選択されることを特徴とする請求項1記載のケージ。
- 前記骨伝導性無機物被覆膜が、カルシウム化合物で構成されていることを特徴とする請求項1記載のケージ。
- 前記骨伝導性無機物被覆膜が、ヒドロキシアパタイト、カルシウム欠損炭酸含有ヒドロキシアパタイト、リン酸三カルシウム、無定形リン酸カルシウム、リン酸八カルシウム、リン酸二カルシウム、リン酸カルシウム、及び、それらの混合物から選択されることを特徴とする請求項1記載のケージ。
- 前記生体適合性材料が、ポリカプロラクトンで構成されることを特徴とする請求項1記載のケージ。
- 前記生体適合性材料がポリカプロラクトンで構成され、前記固定板が、ポリカプロラクトンで構成されることを特徴とする請求項1記載のケージ。
- 前記骨が、隣接する椎骨であることを特徴とする請求項1記載のケージ。
- 前記第1壁、第2壁、及び第3壁の少なくとも1つが、前記固定板に垂直とされていることを特徴とする請求項1記載のケージ。
- 前記第1壁、第2壁、及び第3壁の少なくとも1つが、それの基部側で前記中央部に連結されていることを特徴とする請求項1記載のケージ。
- 前記固定板が、前記中央部の上縁部分から延在していることを特徴とする請求項1記載のケージ。
- 前記固定板が、第1壁、第2壁、及び第3壁の少なくとも1つに垂直に延在していることを特徴とする請求項14記載のケージ。
- 脊椎の融合を促進する多孔性微細構造体ケージであって、
固定板と、
上縁部分、底縁部分を有する中央部と、
前記中央部の前記上縁部分と前記底縁部分との間から延在する第1高さ、前記中央部を横断する方向に延在する第1長さ、及び第1幅を有し、前記第1長さと前記第1高さが前記第1幅よりも大きい第1壁と、
前記中央部の前記上縁部分と前記底縁部分との間から延在する第2高さ、前記中央部を横断する方向に延在する第2長さ、及び第2幅を有し、前記第2長さと前記第2高さが前記第2幅よりも大きい第2壁と、
前記中央部の前記上縁部分と前記底縁部分との間から延在する第3高さ、前記中央部を横断する方向に延在する第3長さ、及び第3幅を有し、前記第3長さと前記第3高さが前記第3幅よりも大きく、前記第3幅だけ離れた第1側面及び第2側面を有し、前記第1壁と前記第2壁との間に位置付けられ、前記第1側面が前記第1壁に対面し、第2側面が前記第2壁に対面する第3壁と、を備え、
前記第1壁が前記中央部において以外は前記第2壁に連結されず、
前記固定板が中央部から伸長し、
前記中央部、前記第1壁、前記第2壁、及び前記第3壁が、多孔性微細構造体を含み、該多孔性微細構造体が、高分子材料、金属材料、セラミック材料及びそれらの混合物から選択される生体適合性材料を含み、
それぞれが異なる溶解特性を有する複数の層を有する、少なくとも1つの前記壁の一部分上の骨伝導性無機物被覆膜と、
高分子材料及び前記被覆膜の少なくとも1つに関連し前記隣接する骨又は隣接する骨表面に骨化を誘発する量で存在する生体活性剤と、をさらに備え、
前記第1壁、第2壁、及び第3壁の少なくとも1つが、前記上縁部分及び前記底縁部分の間の側面から、垂直に延在する突起を有している
ことを特徴とする多孔性微細構造体ケージ。 - 前記高分子材料が、多孔性ポリカプロラクトンとされることを特徴とする請求項16記載の多孔性微細構造体ケージ。
- 前記生体活性剤が、骨形成タンパクから選択されていることを特徴とする請求項16記載の多孔性微細構造体ケージ。
- 前記骨伝導性無機物被覆膜が、カルシウム化合物を有していることを特徴とする請求項16記載の多孔性微細構造体ケージ。
- 前記固定板が、高分子材料を有していることを特徴とする請求項16記載の多孔性微細構造体ケージ。
- 医療画像装置を介して改善した視認性を提供するトレーサを含む少なくとも1つのマーキングが設けられていることを特徴とする請求項16記載の多孔性微細構造体ケージ。
- 前記ケージが、材料を含まない又は放射線透過性材料の領域を含み、その領域に、視認性の改善された医療画像装置を介する画像窓が形成されることを特徴とする請求項16記載の多孔性微細構造体ケージ。
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-
2007
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- 2007-10-30 WO PCT/US2007/082952 patent/WO2008070355A2/en active Application Filing
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JP2010508125A (ja) | 2010-03-18 |
WO2008070355A3 (en) | 2008-08-28 |
ES2596520T3 (es) | 2017-01-10 |
JP2015042269A (ja) | 2015-03-05 |
US9439948B2 (en) | 2016-09-13 |
US20080215093A1 (en) | 2008-09-04 |
AU2007329676A2 (en) | 2009-12-24 |
CA2671335C (en) | 2015-10-13 |
EP2094201A4 (en) | 2012-01-25 |
EP2094201B1 (en) | 2016-09-14 |
EP2094201A2 (en) | 2009-09-02 |
AU2007329676A1 (en) | 2008-06-12 |
CA2671335A1 (en) | 2008-06-12 |
AU2007329676B2 (en) | 2013-10-10 |
WO2008070355A2 (en) | 2008-06-12 |
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