JP2023529954A - 動物の骨からの異種移植片の製造 - Google Patents
動物の骨からの異種移植片の製造 Download PDFInfo
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- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 110
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 7
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- 238000000034 method Methods 0.000 claims abstract description 44
- 239000012634 fragment Substances 0.000 claims abstract description 35
- 239000002904 solvent Substances 0.000 claims abstract description 21
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 21
- 239000008213 purified water Substances 0.000 claims abstract description 18
- 238000005406 washing Methods 0.000 claims abstract description 16
- 239000012074 organic phase Substances 0.000 claims abstract description 10
- 238000001035 drying Methods 0.000 claims abstract description 6
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims description 8
- 239000000203 mixture Substances 0.000 claims description 7
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims description 6
- 239000005708 Sodium hypochlorite Substances 0.000 claims description 4
- SUKJFIGYRHOWBL-UHFFFAOYSA-N sodium hypochlorite Chemical compound [Na+].Cl[O-] SUKJFIGYRHOWBL-UHFFFAOYSA-N 0.000 claims description 4
- 229910001867 inorganic solvent Inorganic materials 0.000 claims description 3
- 239000003049 inorganic solvent Substances 0.000 claims description 3
- 239000003960 organic solvent Substances 0.000 claims description 3
- 238000000926 separation method Methods 0.000 claims description 3
- 210000001519 tissue Anatomy 0.000 claims description 3
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- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 6
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 6
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- 235000019731 tricalcium phosphate Nutrition 0.000 description 4
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- 235000011010 calcium phosphates Nutrition 0.000 description 2
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- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 208000027205 Congenital disease Diseases 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
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- 210000004369 blood Anatomy 0.000 description 1
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- 229910052791 calcium Inorganic materials 0.000 description 1
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- 238000004140 cleaning Methods 0.000 description 1
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- 230000002950 deficient Effects 0.000 description 1
- 230000018044 dehydration Effects 0.000 description 1
- 238000006297 dehydration reaction Methods 0.000 description 1
- 238000005906 dihydroxylation reaction Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 238000010304 firing Methods 0.000 description 1
- 210000004195 gingiva Anatomy 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 238000001027 hydrothermal synthesis Methods 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 238000010297 mechanical methods and process Methods 0.000 description 1
- 230000005226 mechanical processes and functions Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
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- 210000003254 palate Anatomy 0.000 description 1
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- 231100000827 tissue damage Toxicity 0.000 description 1
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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
- A61L27/36—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
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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
- A61L27/36—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
- A61L27/3645—Connective tissue
- A61L27/365—Bones
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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
- A61L27/36—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
- A61L27/3687—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 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
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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
- A61L27/36—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
- A61L27/3691—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 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
-
- 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
- A61L2430/12—Materials or treatment for tissue regeneration for dental implants or prostheses
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/40—Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
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- Public Health (AREA)
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- Veterinary Medicine (AREA)
- Botany (AREA)
- General Health & Medical Sciences (AREA)
- Dermatology (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Animal Behavior & Ethology (AREA)
- Molecular Biology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Zoology (AREA)
- Urology & Nephrology (AREA)
- Vascular Medicine (AREA)
- General Chemical & Material Sciences (AREA)
- Materials For Medical Uses (AREA)
- Meat, Egg Or Seafood Products (AREA)
- Prostheses (AREA)
Abstract
Description
i)1atmを超える圧力及び100℃~300℃の範囲の温度で、溶媒で海綿骨の水熱及び/又はソルボサーマル処理を行う工程ステップを含む。
a)海綿組織を有する動物の骨(例えば、大腿骨の頭部-大腿骨頭)を粉砕することによる海綿骨断片の取得。それに応じて、骨の海綿質部分を軟骨及び皮質骨から分離することができるので、海綿骨断片を、好ましくは0.5~1.5センチメートル程度で得ることができる。
b)海綿骨断片中の有機相の部分的除去(例えば、脂肪、血液、及びその他の望ましくない有機相の部分的除去/分離)。それに応じて、例えば、海綿骨断片は精製水で1~2時間の間に10~15回洗浄してもよく、精製水で30~60分間の間に3~5回煮沸してもよい。
c)海綿骨の有機相のさらなる除去/分離。それに応じて、海綿骨は、有機成分(例えば、タンパク質、脂肪、DNA、細胞など)を溶解することができる溶媒と接触させることができ、このステップは、「化学処理ステップ」及び「脱細胞」と呼ばれることがある。このステップでは、海綿骨を、次亜塩素酸ナトリウム、クロロホルム、アセトン、若しくはそれらの混合物などの、有機相(脂肪、タンパク質など)を溶解し、海綿骨から有機相を除去する溶媒、さらに、又は他の有機、無機、及びイオン溶液(塩溶液など)若しくはそれらの混合物とも、例えば、7~15日間の期間接触させ、好ましくは継続的に撹拌する。
d)海綿骨断片の洗浄。洗浄ステップによって、海綿骨断片は、ステップ(c)で述べた溶媒及び他の可能な残留物から取り出される。前記洗浄工程は、例えば精製水で1~2時間の間に10~15回繰り返してもよい。
e)海綿骨断片の洗浄。こうして、海綿骨断片にまだ存在している可能性のあるいかなる残留物も除去される。前記洗浄工程は、例えば、水、例えば、精製水で実施することができる。洗浄工程は、例えば、1日~7日の期間で、例えば3回以上繰り返してもよい。
f)乾燥による海綿骨断片の脱水。前記乾燥工程は、例えば、50℃~100℃の範囲の温度で、例えば、1~2日の範囲の期間で実施することができる。
20 フィルターパッド
30 保持器
40 カップリングカバー
50 カバー
60 ライナー
70 外殻
80 溶媒
90 基部
Claims (12)
- 1atmを超える圧力及び100℃~300℃の範囲の温度で、溶媒で海綿骨の水熱及び/又はソルボサーマル処理を行うステップを含むことを特徴とする、異種骨移植片を製造するための方法。
- 前記溶媒が、有機溶剤、無機溶媒、イオン溶液、及びそれらの混合物から選択される、請求項1に記載の方法。
- 前記溶媒が、精製水、次亜塩素酸ナトリウム、クロロホルム、アセトン、又はそれらの混合物から選択される、請求項2に記載の方法。
- 前記水熱及び/又はソルボサーマル処理ステップが6時間~24時間の期間継続される、請求項1~3のいずれか一項に記載の方法。
- 前記水熱及び/又はソルボサーマル処理ステップの前に、
a)海綿組織を有する動物の骨を粉砕することによる海綿骨断片の取得、
b)前記海綿骨断片中の有機相の部分的除去、
c)前記海綿骨の前記有機相のさらなる除去/分離、
d)前記海綿骨断片の洗浄、
のステップを順番に含む、請求項1~4のいずれか一項に記載の方法。 - ステップ(b)において、前記海綿骨断片を精製水で1時間~2時間の期間に10~15回の範囲の反復数で洗浄し、精製水で30分~60分の期間に3~5回の範囲の反復数で煮沸する、請求項5に記載の方法。
- ステップ(c)において、前記海綿骨を、有機成分を溶解することができる溶媒と7日~15日の期間で接触させる、請求項5又は6に記載の方法。
- 前記有機成分を溶解することができる前記溶媒が、有機溶剤、無機溶媒、イオン溶液、及びそれらの混合物から選択される、請求項7に記載の方法。
- ステップ(d)の前記洗浄工程が、精製水で1時間~2時間の期間に10~15回の範囲の反復数で繰り返される、請求項5~8のいずれか一項に記載の方法。
- 前記水熱及び/又はソルボサーマル処理ステップの後に、
e)前記海綿骨断片の洗浄、
f)前記海綿骨断片の乾燥、
のステップを順番に含む、請求項1~9のいずれか一項に記載の方法。 - ステップ(e)の前記洗浄工程が、精製水で1~7日の期間に3回以上繰り返して実行される、請求項10に記載の方法。
- ステップ(f)の前記乾燥工程が、1~2日の期間で50℃から100℃の範囲の温度で実行される、請求項10又は11に記載の方法。
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TR2020/09080 | 2020-06-11 | ||
TR2020/09080A TR202009080A2 (tr) | 2020-06-11 | 2020-06-11 | Hayvan kemiğinden ksenogreft üretimi. |
PCT/IB2020/001062 WO2021250439A1 (en) | 2020-06-11 | 2020-12-07 | Production of xenograft from animal bones |
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US (1) | US20230218802A1 (ja) |
EP (1) | EP4164707A1 (ja) |
JP (1) | JP7460048B2 (ja) |
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CN114848920B (zh) * | 2022-04-13 | 2023-06-06 | 南京航空航天大学 | 一种多孔块状异种骨修复材料的极短流程免煅烧制备方法 |
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AU755316B2 (en) | 1998-03-16 | 2002-12-12 | Crosscart, Inc. | Bone xenografts |
US20050266037A1 (en) | 2004-05-25 | 2005-12-01 | Agency For Science, Technology & Research, A Comp. Organized & Existing Under The Laws Of Singapore | Implantable biomaterial and method for the preparation thereof |
WO2013008959A1 (ko) | 2011-07-08 | 2013-01-17 | 서울대학교산학협력단 | 이종골 유래 골이식재 및 그 제조방법 |
US9610381B2 (en) * | 2013-10-08 | 2017-04-04 | Sigmagraft, Inc. | Process for extracting natural hydroxyaptite granules from bovine bone |
CN105107023A (zh) | 2015-07-01 | 2015-12-02 | 李亚屏 | 一种骨移植用可降解多孔复合支架材料 |
CN108653819B (zh) * | 2018-03-12 | 2021-02-12 | 南京航空航天大学 | 短流程制备多孔异种骨骨粉修复材料的方法和由该方法制得的骨修复材料 |
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- 2020-12-07 US US18/009,799 patent/US20230218802A1/en active Pending
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