JPH0555148B2 - - Google Patents

Info

Publication number
JPH0555148B2
JPH0555148B2 JP2250407A JP25040790A JPH0555148B2 JP H0555148 B2 JPH0555148 B2 JP H0555148B2 JP 2250407 A JP2250407 A JP 2250407A JP 25040790 A JP25040790 A JP 25040790A JP H0555148 B2 JPH0555148 B2 JP H0555148B2
Authority
JP
Japan
Prior art keywords
composition
carrier
bone
glycerol
agents
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
JP2250407A
Other languages
English (en)
Other versions
JPH03210270A (ja
Inventor
Kei Orearii Robaato
Ei Makuburaiyaa Patoritsuku
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Osteotech Inc
Original Assignee
Osteotech Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=27021064&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JPH0555148(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US07/410,596 external-priority patent/US5073373A/en
Application filed by Osteotech Inc filed Critical Osteotech Inc
Publication of JPH03210270A publication Critical patent/JPH03210270A/ja
Publication of JPH0555148B2 publication Critical patent/JPH0555148B2/ja
Granted legal-status Critical Current

Links

Classifications

    • 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
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
    • A61L27/3608—Bone, e.g. demineralised bone matrix [DBM], bone powder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/686—Plugs, i.e. elements forming interface between bone hole and implant or fastener, e.g. screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
    • 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
    • A61F2/28—Bones
    • A61F2/2803—Bones for mandibular reconstruction
    • A—HUMAN NECESSITIES
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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
    • A61F2/28—Bones
    • A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
    • 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
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4644—Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/32—Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3641—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the site of application in the body
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A—HUMAN NECESSITIES
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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
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    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2817—Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
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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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    • A61L2400/00—Materials characterised by their function or physical properties
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Chemical & Material Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Surgery (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Botany (AREA)
  • Cardiology (AREA)
  • Zoology (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Rheumatology (AREA)
  • Virology (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Developmental Biology & Embryology (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Plastic & Reconstructive Surgery (AREA)
  • Urology & Nephrology (AREA)
  • Materials For Medical Uses (AREA)

Description

【発明の詳細な説明】 （産業上の利用分野） 本発明は流動性のある脱ミネラル化した骨粉組
成物は骨欠陥の外科的治療での該組成物の使用に
関する。
（従来技術） 骨欠陥の治療に脱ミネラル化した骨粉を用いる
検討は既になされている。骨粉は１以上の部質、
多分骨形成性蛋白質（BMP）を含有しており、
これが欠陥部位における骨の再生を誘発する。た
とえばCovey等のOrthopaedic Review、Vol.
、No.８、857−863（1989年８月）参照。
Habal等のAnnals of Plastic Surgery、
Vol.15、No.２、138−142（1985年８月）によれば、
ペースト状物質にまで粉砕し自生血液と混合した
自生骨を犬の長い骨の欠陥の治療（代替）に用い
ている。
（発明の開示） 本発明の目的は外科的な骨の治療（リペア）に
用いる流動性のある脱ミネラル化した骨粉組成物
を提供することにある。
更に詳しくは本発明の目的は脱ミネラル化した
骨粉と骨粉用キヤリヤとしての液状ポリヒドロキ
シ化合物とからなる液状又はペースト状の組成物
（チキソトロピー剤や医薬等の任意成分はあつて
もなくてもよい）及び該組成物を骨欠陥部位に付
与して新しい骨の内部生長を誘発する方法を提供
することにある。
本発明は液状ポリヒドロキシ化合物、液状ポリ
ヒドロキシ化合物誘導体、固体状ポリヒドロキシ
化合物の溶液、固体状ポリヒドロキシ化合物誘導
体の溶液及びそれらの混合物からなる群から選ば
れた生体適合性キヤリヤと脱ミネラル化した骨粉
からなることを特徴とする骨の欠陥部位の新しい
骨の生長を促進するために骨欠陥部位に付与する
ための流動性組成物にある。
本発明の組成物を骨欠陥部位、たとえばけが、
感染、悪性もしくは進行性の奇形等に基づく欠陥
部位に付与すると骨生成、骨誘導及び骨誘発等の
１又は２以上の機構によつて急速な骨の内部生成
がもたらされる。
本発明の骨粉組成物はそれが必要なときに容易
に調製することができ、好ましくは本発明組成物
の成分を混合するための部材と該組成物を骨欠陥
部位に付与する部材を一体形キツトの形で用意す
る。また本発明の骨粉組成物を予じめ調製し、後
日の使用のために無菌条件下に保存することもで
きる。
本発明組成物における脱ミネラル化した破砕又
は粉末化した骨成分は公知の物質であり公知の方
法でつくられる。ここで「破砕した骨」、「粉末化
した骨」、「骨粉」は比較的微細な粉末から粗粒さ
らには大きなチツプも含む広い範囲の骨粒子を包
含するものである。従つてたとえば本発明組成物
中に存在する骨粉は約0.1〜約1.2cm、より好まし
くは約0.2〜約1.0cmの平均粒径をもちうる。骨粉
は皮質骨、がん性及び／又は副腎皮質の自生、変
異性及び／又は他生の骨組織から得られる。通常
変異性の骨組織が骨粉源として好ましく用いられ
る。
好ましい骨の脱ミネラル化法において、まず骨
を所望の平均粒径に破砕し次いで脱脂／殺菌し、
酸による脱ミネラル化処理する。好ましい脱脂／
殺菌溶液としてはエタノール水溶液がある。エタ
ノールは脂質分に対する良溶媒であり、水はすぐ
れた親水性キヤリヤであり該溶液を骨中により深
く浸透させる。エタノール水溶液はまた直物性微
生物及びウイルスを殺すことにより骨を殺菌す
る。通常少なくとも約10％〜40％の水（即ち約60
％〜90％のアルコール等の脱脂剤）を脱脂、殺菌
溶液中に存在させることが、最適の脂質除去と殺
菌とを最も短時間で達成する上で好ましい。脱脂
溶液の好ましい濃度はアルコール濃度約60％〜85
％であり、最も好ましいアルコール濃度は約70％
である。脱脂に続き、骨を脱ミネラル化するに足
る時間酸中に浸漬する。この操作で用いる酸とし
ては塩酸等の無機酸及び過酢酸等の有機酸があ
る。酸処理後骨粉を射出用に無菌水ですすぎ、バ
ツフアで最終の予めきめたPHに調整し最後に水で
すすぎ残存する酸とバツフアを除く。脱ミネラル
化した骨粉は直ちに本発明の組成物の製造に用い
ることもできるし無菌条件下、好ましくは凍結乾
燥状態で保存して後は組成物の製造に供すること
もできる。
所望により、骨粉を１又は２以上の方法で変性
することもできる。たとえば骨粉の多孔度を増加
させ及び／又は骨粉を１又は２以上の変性剤、た
とえばグルタルアルデヒド（米国特許第4678470）
等で処理することができる。また米国特許第
4743259号及び4902296号に開示されているよう
に、骨粉の骨蛋白含量を増加又は変化させること
もできる。
本発明の流動性のある骨粉組成物には種々の製
薬上／外科上有用な物質を、たとえば所望の物質
の溶液又は分散液に骨粉を浸漬したり、これら物
質をポリヒドロキシ化合物成分に添加したり又は
直接流動性のある骨粉組成物に添加する等の手段
によつて導入することができる。本発明組成物に
容易に導入しうる製薬上／外科上有用な物質に
は、たとえばコラーゲン及び不溶性コラーゲン誘
導体、ヒドロキシアペタイト等、及び可溶性固体
及び／又は液体、たとえば、抗ウイルス剤、特に
HIV及び肝炎に対し有効なもの；抗菌剤及び／
又は抗生物質、たとえばエリスロマイシン、バシ
トラシン、ネオマイシン、ペニシリン、ポリミキ
シンＢ、テトラサイクリン、バイオマイシン、ク
ロロマイセチン、ストレプトマイシン、セフアゾ
リン、アムピシリン、アザクタム、トブラマイシ
ン、エリンダマイシン及びゲンタマイシン等；ア
ミノ酸、ペプチド、ビタミン、無機元素、蛋白合
成用コフアクター、ホルモン、内分泌腺組織又は
組織フラグメント、シンセサイザー、酵素、たと
えばコラーゲン、ペプチダーゼ、オキシダーゼ
等、実質細胞を伴なつたポリマーセル骨組剤、脈
管形成剤及びこれら医薬を含有するポリマーキヤ
リヤ、コラーゲン格子、生化学的相溶性のある表
面活性剤、抗原剤、細胞骨格剤、軟骨フラグメン
ト、生細胞、たとえばコンドロサイト、骨髄細
胞、間葉ステム細胞、天然抽出物、組織移植体、
生化学接着剤、組織形成性蛋白（BMP）、トラン
スフオーミング生長因子（TGF−β）、インシユ
リン様生長因子（IGF−１）、生長ホルモン、た
とえばソマトトロピン、骨分解剤、抗腫瘍剤、フ
イブロネクチン、細胞誘引剤、細胞接着剤、免疫
抑制剤、透過性増強剤、たとえばポリエチレング
リコールのラウレート、ミリステート及びステア
レート等の脂肪酸エステル、エチミン誘導体、ア
ルフアケトアルデヒド等、核酸、及び米国特許第
4764364号、4765973号及びヨーロツパ特許出願第
168277号に開示されているような生化学分解性ポ
リマー等がある。これら任意添加成分の量は広範
囲で変化させうるが、それぞれの最適量は通常の
実験で容易に決定しうる。
本発明の脱ミネラル化した骨粉組成物は、前記
した如き脱ミネラル化した骨粉を、骨粉用のキヤ
リヤ又は懸濁剤として機能する生化学的相溶性の
ある液状ポリヒドロキシ化合物と組合せることに
よつて得られる。
ここで「液状ポリヒドロキシ化合物」、「液状ポ
リヒドロキシ化合物誘導体」とは、純粋又は高濃
度状態で且つ周囲温度、たとえば15〜40℃で、流
動性のある液体である形の化合物を包含するもの
である。ここで用いる「固体状ポリヒドロキシ化
合物」、「固体状ポリヒドロキシ化合物誘導体」と
は、純粋又は高濃度状態で且つ周囲温度にて、通
常固体又は半固体であるが、適当な溶媒、たとえ
ば水、生理的食塩水、エタノール、グリセロー
ル、グルコース、プロピレングリコール、ポリエ
チレングリコール（分子量200〜1000）等又はそ
れらの混合物には溶けて液状組成物となる形の化
合物を包含するものである。機能的には、骨粉組
成物のキヤリヤ成分は広範囲の濃度の流動性物質
をもたらしうるものである。ここで「流動性（の
ある）」とは形状保持性はあるが容易に変形しう
る濃度は、たとえばパテのような挙動を示すもの
等をも包含するものである。流動性のある骨粉組
成物の特殊な形にはケーキ、ペースト、クリー
ム、フイラー等がある。
有用なポリヒドロキシ化合物は２〜約18の炭素
をもち非環状多価アルコール、非還元性シユガ
ー、シユガーアルコール、シユガー酸、モノサツ
カライド、ジサツカライド、水溶性又は水分散性
オリゴサツカライド、ポリサツカライド、及びこ
れらの公知の誘導体等がある。ポリヒドロキシ化
合物の更なる例にはエチレングリコール、ジエチ
レングリコール、トリエチレングリコール、１，
２−プロパンジオール、トリメチロールエタン、
トリメチロールプロパン、エリスリトール、ペン
タエリスリトール、ポリアルキレングリコール、
たとえばポリエチレングリコール、キシリトー
ル、ソルビトール、マンニトール、ダルシトー
ル、アラビノース、キシロース、リボース、アド
ニトール、アラビトール、ラモーゼ、イノシトー
ル、フラクトース、ガラクトース、グルコース、
マンノース、ソルボース、スクロース、マルトー
ス、ラクトース、マルチトール、ラクチトール、
スタチオース、マルトペンタオース、シクロマル
トヘキサオース、カラギーナン、寒天、アルギン
酸、グアーガム、ガムトラガカンス、Ｏ−カスト
ビーンガム、アラビアガム、キサンタンガム、ア
ミロース、前記いづれかの混合物等がある。
前記ポリヒドロキシ化合物の誘導体、特にエス
テル誘導体も有用である。たとえばグリセロール
の液状及び固体状モノエステル及びジエステルは
すぐれた効果を示す。この固体状エステルはプロ
ピレングリコール、グリセロール、ポリエチレン
グリコール（分子量200〜1000）等の適当なビヒ
クルにそれらの溶解度限度まで溶解される。液状
グリセロールエステルには特に好ましいグリセロ
ールモノラウレート、グリセロールパルミテー
ト、グリセロールモノステアレート等のグリセロ
ールの脂肪酸モノエステルがある。特に好ましい
キヤリヤはグリセロールに溶解したグリセリルモ
ノラウレート又はグリセロールとプロピレングリ
コールとの４：１〜１：４混合物からなるもので
ある。
前記したポリヒドロキシ化合物のうち、グリセ
ロール及びその液状モノエステル及びジエステ
ル、たとえばモノアセチン、ジアセチン、フラク
トース、グルコース及びスクロース及びそれらの
混合物がより好ましい。ポリヒドロキシ化合物が
たとえばスクロースのように固体である場合に
は、水、グリセロール、ポリエチレングリコール
（平均分子量200〜1000）又はそれらの混合物等の
溶媒を用いてこの化合物の流動性のある溶液又は
ペーストにすることが好ましい。
骨粉がキヤリヤからすぐに又は分離するとか沈
澱する傾向があつて均一組成物の付与が困難な場
合には、その傾向を抑え又は減少させるチキソト
ロピー特性をもつ物質を添加することが好まし
い。たとえばキヤリヤ成分がグリセロールで骨粉
の分離が過度に起こる場合には、ポリビニルアル
コール、ポリビニルピロリドン、セルロースエス
テル、たとえばヒドロキシプロピルメチルセルロ
ース、カルボキシメチルセルロース、ペクチン、
食品級のテキスチヤリング剤、ゼラチン、デキス
トラン、コラーゲン、でんぷん、水解ポリアクリ
ロニトリル、水解ポリアクリルアミド、多電解
質、たとえばポリアクリル酸塩等を組成物の懸濁
維持特性を改良するに十分な量でキヤリヤに添加
しうる。
前記したように、本発明の骨粉組成物は、骨粉
とキヤリヤと任意成分を適宜の混合順序又は同時
に混合することにより、使用直前に調製すること
ができる。骨粉はまず任意成分と混合し、次いで
キヤリヤ成分と混合してもよいし、骨粉をキヤリ
ヤ成分と混合してから任意成分を添加してもよい
し、又は任意成分をキヤリヤに添加してから骨粉
を添加してもよい。これらの添加操作の順序の変
更は勿論可能である。本発明組成物に導入される
骨粉の量は約５〜約90重量％、好ましくは約20〜
約80重量％であり、残余はキヤリヤが占めうる。
本発明組成物を使用時に調製するために、骨粉、
好ましくは凍結状態の骨粉、とキヤリヤ（前記し
た任意成分を含有する）とを、無菌状態で、別々
のパツケージ又は容器中に保存し使用時に適宜の
部材を用いて骨欠陥部位に直ちに付与できるよう
にすることができる。この場合の付与部材として
はシリンジへら等がある。米国特許第4458733号
には前記の保存と混合と付与を行なうに適する保
存、混合、付与（塗布）部材が開示されており、
本発明にも有効である。また骨粉組成物を多量に
調製し使用時までシリンジその他の適当な塗付装
置の胴体内に無菌状態で保存することもできる。
本発明の骨粉組成物は種々の方法で骨欠陥部位
に付与しうる。たとえば高粘性ペースト状の組成
物で該部位を充填する等の方法が用いうる。本発
明組成物は、標準的な関節形成性、骨格又は他の
骨欠陥の再構成に有効に用いうるしまた内部及び
外部固定装置の有効性を増大する。
次に実施例により本発明の流動性のある脱ミネ
ラル化した骨粉組成物の調製について説明する。
実施例 １ 一定量の同種の皮質性又は海綿質の骨を破砕し
て約100〜約500μの平均粒径のものをふるいと
り、反応器に入れ密封した。70％エタノール溶液
を骨１ｇ当り30mlの割合で反応器に入れ１時間撹
拌し（Bolander等、Journal of Bone and
Joint Surgery、Vol.68−Ａ、No.８（1986年10月）、
骨粉の脱脂と消毒をした。エタノールをぬいてか
ら0.6NのHCl溶液の骨１ｇ当り50ml反応器に入
れ（Bolander等上記）、反応を３時間行なう
（Glowackie、AATB Workshop、第11回年次会
議（1987））。HClをぬいてから骨をインジエクシ
ヨン（WFI）用の水で３回すすぎ、WFIは５分
間隔で置きかえた。WFIをぬいてから、骨を
0.1Mのリン酸ナトリウムで完全にカバーし溶液
のPHが6.8〜7.4の間になるまでこの操作をくりか
えした。WFIでのすすぎ法をくりかえして脱ミ
ネラル化した皮質性又は海綿質の骨粉をつくつ
た。
このようにしてつくつた脱ミネラル化した骨粉
25ｇと注射級のグリセロール95ｇを十分に混合し
てペースト状濃度の組成物をつくつた。この組成
物はシリンジ、ヘラ、デンタルガムその他の適当
な装置を用いて、骨欠陥部位に容易に付与でき
る。
実施例 ２ 実施例１の脱ミネラル化した骨粉をフラクトー
ス50重量％、デキストロース50重量％の流動性混
合物と３つの異なる濃度で混合してそれぞれ骨粉
を25、35及び50重量％含有する流動性のある脱ミ
ネラル化した骨粉ペーストをつくつた。この骨粉
ペーストは組成物全体が堅牢且つなめらかで空気
中で８〜12時間で硬化した。
骨粉用の液状ポリヒドロキシ化合物キヤリヤと
してスクロース水溶液を用いて同様の結果を得
た。

Claims (1)

  1. 【特許請求の範囲】 １ 液状ポリヒドロキシ化合物、液状ポリヒドロ
    キシ化合物誘導体、固体状ポリヒドロキシ化合物
    の溶液、固体状ポリヒドロキシ化合物誘導体の溶
    液及びそれらの混合物からなる群から選ばれた生
    体適合性キヤリヤと脱ミネラル化した骨粉からな
    ることを特徴とする骨の欠陥部位の新しい骨の生
    長を促進するために骨欠陥部位に付与するための
    流動性組成物。 ２ 該キヤリヤがグリセロール、グリセロールモ
    ノエステル又はグリセロールジエステルである請
    求項１記載の組成物。 ３ 該キヤリヤがモノサツカライド、モノサツカ
    ライド誘導体、ジサツカライド、ジサツカライド
    誘導体、オリゴサツカライド、オリゴサツカライ
    ド誘導体又はこれらの混合物である請求項１記載
    の組成物。 ４ 該キヤリヤがフラクトース、グルコース又は
    それらの混合物である請求項１記載の組成物。 ５ 該キヤリヤがスクロースの溶液である請求項
    １記載の組成物。 ６ 該キヤリヤがスクロースの水溶液である請求
    項１記載の組成物。 ７ 該キヤリヤがグリセロールの脂肪酸モノエス
    テルの溶液である請求項１記載の組成物。 ８ 該キヤリヤが異なる液状ポリヒドロキシ化合
    物及び／又はその誘導体に溶解した脂肪酸モノエ
    ステルである請求項１記載の組成物。 ９ 該キヤリヤがクロロピレングリコール、グリ
    セロール、モノアセチン、ジアセチン、液状ポリ
    エチレングリコール及びそれらの混合物からなる
    群から選ばれた溶媒に溶かした脂肪酸モノエステ
    ルである請求項１記載の組成物。 １０ キヤリヤが溶媒に溶かしたグリセロールモ
    ノラウレートである請求項１記載の組成物。 １１ 該キヤリヤが異なる液状ポリヒドロキシ化
    合物及び／又はその誘導体に溶解した脂肪酸モノ
    エステルである請求項１記載の組成物。 １２ 該キヤリヤがクロロピレングリコール、グ
    リセロール、モノアセチレン、ジアセチレン、液
    状ポリエチレングリコール及びそれらの混合物か
    らなる群から選ばれた溶媒に溶かした脂肪酸モノ
    エステルである請求項１記載の組成物。 １３ 該脱ミネラル化した骨粉の平均粒子径が約
    0.1〜約1.2cmである請求項１記載の組成物。 １４ 該脱ミネラル化した骨粉の平均粒子径が約
    0.2〜約１cmである請求項１記載の組成物。 １５ 該脱ミネラル化した骨粉が皮質骨、がん性
    及び／又は副腎皮質の自生、変異性及び／又は他
    生の骨組織から誘導されたものである請求項１記
    載の組成物。 １６ 脱ミネラル化した骨粉を約５〜約90重量
    ％、キヤリヤを約10〜約95重量％含有する請求項
    １記載の組成物。 １７ 脱ミネラル化した骨粉を約20〜約80重量
    ％、キヤリヤを約20〜約80重量％含有する請求項
    １記載の組成物。 １８ 抗菌剤、抗生物質、抗ウイルス剤、アミノ
    酸、ペプチド、ビタミン、無機元素、蛋白合成コ
    フアクター、ホルモン、内分泌腺組織、シンセサ
    イザー、酵素、実質細胞を伴つたポリマー−セル
    骨組剤、脈管形成剤、ポリマー性の医薬キヤリ
    ヤ、コラーゲン格子、抗原剤、細胞骨格剤、間葉
    ステム細胞、骨分解剤、抗腫瘍剤、細胞誘引剤、
    フイブロネクチン、生長ホルモン、細胞接着剤、
    ヒドロキシアパタイト及び透過性増強剤からなる
    群から選ばれる少なくとも１の添加成分を含有し
    てなる請求項１記載の組成物。 １９ 生化学分解性ポリマーを含有する請求項１
    記載の組成物。 ２０ 骨組織形成性蛋白、トランスホーミング生
    長因子、およびインシユリン様生長因子の少なく
    とも１つから選ばれた少なくとも１つの追加成分
    を含む請求項１記載の組成物。 ２１ ポリビニルアルコール、ポリビニルピロリ
    ドン、ヒドロキシプロピルメチルセルロース、カ
    ルボキシメチルセルロース、ペクチン、食品級の
    テキスチヤリング剤、ゼラチン、デキストラン、
    コラーゲン、でんぷん、水解ポリアクリロニトリ
    ル、水解ポリアクリルアミド、およびポリアクリ
    ル酸塩の少なくとも１つから選ばれたシツクナー
    を追加して含む請求項１記載の組成物。 ２２ 脱ミネラル化した骨形成用骨粉を酸脱ミネ
    ラル化処理にかける請求項１記載の組成物。 ２３ 脱ミネラル化した骨粉を更に脱脂／殺菌処
    理にかける請求項２２記載の組成物。 ２４ キヤリヤがスクロースとグリセロールとの
    流動性のある溶液又はペーストである請求項１記
    載の組成物。 ２５ キヤリヤがスクロースとポリエチレングリ
    コールとの流動性のある溶液又はペーストである
    請求項１記載の組成物。
JP2250407A 1989-09-21 1990-09-21 流動性のある脱ミネラル化した骨粉組成物及びその骨治療での使用 Granted JPH03210270A (ja)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US410596 1989-09-21
US07/410,596 US5073373A (en) 1989-09-21 1989-09-21 Flowable demineralized bone powder composition and its use in bone repair
US573458 1990-08-27
US07/573,458 US5290558A (en) 1989-09-21 1990-08-27 Flowable demineralized bone powder composition and its use in bone repair

Publications (2)

Publication Number Publication Date
JPH03210270A JPH03210270A (ja) 1991-09-13
JPH0555148B2 true JPH0555148B2 (ja) 1993-08-16

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JP2250407A Granted JPH03210270A (ja) 1989-09-21 1990-09-21 流動性のある脱ミネラル化した骨粉組成物及びその骨治療での使用

Country Status (4)

Country Link
US (4) US5290558A (ja)
EP (1) EP0419275B1 (ja)
JP (1) JPH03210270A (ja)
DE (1) DE69016331T2 (ja)

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US5290558A (en) 1994-03-01
US5439684A (en) 1995-08-08
US5284655A (en) 1994-02-08
DE69016331T2 (de) 1995-09-21
JPH03210270A (ja) 1991-09-13
EP0419275B1 (en) 1995-01-25
DE69016331D1 (de) 1995-03-09
EP0419275A1 (en) 1991-03-27

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