JP6192014B2 - 生体インプラント - Google Patents
生体インプラント Download PDFInfo
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- JP6192014B2 JP6192014B2 JP2013556300A JP2013556300A JP6192014B2 JP 6192014 B2 JP6192014 B2 JP 6192014B2 JP 2013556300 A JP2013556300 A JP 2013556300A JP 2013556300 A JP2013556300 A JP 2013556300A JP 6192014 B2 JP6192014 B2 JP 6192014B2
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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
- A61L27/28—Materials for coating prostheses
- A61L27/30—Inorganic materials
- A61L27/32—Phosphorus-containing materials, e.g. apatite
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- 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
-
- 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
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
-
- 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
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/022—Metals or alloys
-
- 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
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
- A61L31/028—Other inorganic materials not covered by A61L31/022 - A61L31/026
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
- A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
- A61L2300/104—Silver, e.g. silver sulfadiazine
-
- 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
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Biomedical Technology (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Surgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Molecular Biology (AREA)
- Cardiology (AREA)
- Physical Education & Sports Medicine (AREA)
- Rheumatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Description
本発明の生体インプラントは、金属、セラミックスまたはプラスチックからなる基体上の少なくとも一部に、リン酸カルシウム系材料からなる溶射被膜が形成され、該溶射被膜中の銀濃度が、0.05重量%〜3.00重量%であることを特徴とするものである。
リン酸カルシウム系材料からなる溶射被膜を形成するために用いる溶射法としては、フレーム溶射法、高速フレーム溶射法、プラズマ溶射法およびコールドスプレー法を挙げることができる。例えば、フレーム溶射法では、酸素と可燃性ガスとのガス炎を熱源として溶射材料を溶融または溶融に近い状態にして母材の表面に吹き付けて被膜を形成する。通常のフレーム溶射法では、溶射温度は約2700℃、溶射速度マッハ0.6である。溶射条件として、例えば、酸素ガス 50psi、アセチレンガス 43psiのガスフレームトーチ中に、100psiのドライエアーで溶射粉末を導入し、溶射距離60〜100mmで溶射を行うことができる。
(試験片作製)
50mm×50mm×2mmの純チタン板の片面に、所定量の酸化銀を添加したヒドロキシアパタイトを、フレーム溶射法にて溶射することにより、厚さ約40μmの溶射被膜を形成した。
試験片を100℃にて十分乾燥後、秤量した後、硝酸溶液(硝酸5mL+純水50mL)に加熱溶解させた。この溶液中の銀濃度をICP発光分光分析法にて定量分析し、被膜中の銀濃度を求めた。次に被膜を溶解させて除去した後の試験片を十分乾燥させ、再び秤量して、被膜溶解前との重量差から、被膜重量を求めた。被膜中の銀量を被膜の重量で割って、被膜中の銀濃度(重量%)を算出した。本実施例の被膜中の銀濃度は0.3重量%であった。
抗菌性能試験として、バイオフィルム形成阻害性能の評価を行った。
試験片にメチシリン耐性黄色ブドウ球菌を付着させた後、37℃に保持した牛血清中に浸漬し、60rpmで攪拌し、流動状態下で培養した。培養1週間後および2週間後、被膜上に形成されたバイオフィルムを蛍光染色し、蛍光顕微鏡によりバイオフィルムの被覆率を測定するとともに形態観察も行った。なお、バイオフィルム被覆率の算出には画像解析ソフトウェアを使用し、蛍光発光部分の表面積割合から、被覆率を求めた。
酸化銀を添加しないヒドロキシアパタイトを用いた以外は、実験例1と同様にして試験片を作製し、抗菌性能試験に供した。
バイオフィルムの被覆率を表1に示す。1週間培養と2週間培養のいずれにおいても、実験例1では、コントロールに比し、バイオフィルムの被覆率が低くなり、バイオフィルムの形成を阻害することを確認できた。
本実験例は、被膜中の銀濃度の影響を再確認するために行ったものであり、銀濃度(重量%)は、0%、0.05%、0.1%、0.3%とした。
直径14mm、厚さ1mmの純チタン板の片面に、所定の酸化銀を添加したヒドロキシアパタイトをフレーム溶射して、厚さ40μmの溶射被膜を形成した。この時、酸化銀の添加量を調整することにより、被膜中の銀濃度(重量%)が0%、0.05%、0.1%、0.3%の4種の試験片を製作した。
銀濃度の測定は、実験例1と同様の方法により行った。
抗菌性能試験として、バイオフィルム形成阻害試験を行った。牛血清培地内の細菌が飽和状態になることを避けるため、培地を3日おきに交換した以外は、実験例1と同様の方法により行った。
表2にバイオフィルム被覆率の測定結果を示す。1週間後培養と2週間後培養のいずれにおいても、被膜中の銀濃度に比例してバイオフィルム被覆率の低下が認められた。これにより、被膜中の銀濃度が増加すると、バイオフィルムの形成が阻害されることを確認できた。なお、本実験例の結果、および経験的な細菌増殖の知見を考慮すると、銀濃度が0.05%であれば約4週間、0.1%であれば約6週間、0.3%であれば約10週間においてバイオフィルム形成阻害効果を保持するものと推定される。
Claims (1)
- 金属またはセラミックスからなる基体上の少なくとも一部に、リン酸カルシウム系材料を溶射材料とする溶射被膜が形成され、該溶射被膜中の銀濃度が、0.05重量%〜3.00重量%であり、該溶射被膜が水和され、該溶射被膜の表面にヒドロキシアパタイトが存在する、生体インプラント。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2012022205 | 2012-02-03 | ||
JP2012022205 | 2012-02-03 | ||
PCT/JP2013/050661 WO2013114947A1 (ja) | 2012-02-03 | 2013-01-16 | 生体インプラント |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017091356A Division JP6289708B2 (ja) | 2012-02-03 | 2017-05-01 | 生体インプラント |
Publications (2)
Publication Number | Publication Date |
---|---|
JPWO2013114947A1 JPWO2013114947A1 (ja) | 2015-05-11 |
JP6192014B2 true JP6192014B2 (ja) | 2017-09-06 |
Family
ID=48904990
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013556300A Active JP6192014B2 (ja) | 2012-02-03 | 2013-01-16 | 生体インプラント |
JP2017091356A Active JP6289708B2 (ja) | 2012-02-03 | 2017-05-01 | 生体インプラント |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2017091356A Active JP6289708B2 (ja) | 2012-02-03 | 2017-05-01 | 生体インプラント |
Country Status (4)
Country | Link |
---|---|
US (1) | US20150018965A1 (ja) |
EP (1) | EP2810665B1 (ja) |
JP (2) | JP6192014B2 (ja) |
WO (1) | WO2013114947A1 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2021049494A1 (ja) | 2019-09-11 | 2021-03-18 | 京セラ株式会社 | 生体インプラント、および生体インプラントの製造方法 |
Families Citing this family (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11278642B2 (en) | 2006-09-08 | 2022-03-22 | Takao Hotokebuchi | Bioimplant with evanescent coating film |
US10814039B2 (en) * | 2012-02-03 | 2020-10-27 | Kyocera Corporation | Bioimplant with antibacterial coating and method of making same |
US9160515B2 (en) * | 2013-04-04 | 2015-10-13 | Intel IP Corporation | User equipment and methods for handover enhancement using scaled time-to-trigger and time-of-stay |
EP3328451B1 (en) * | 2015-07-28 | 2019-09-11 | CeramTec GmbH | Implants with at least one osseointegrative and anti-microbial surface (multi)layer structure |
KR20180063200A (ko) * | 2015-09-29 | 2018-06-11 | 세람테크 게엠베하 | 열용사된 세라믹 층들 |
EP4098228A4 (en) | 2020-01-31 | 2024-03-13 | Kyocera Corporation | SPINAL COLUMN IMPLANT AND METHOD FOR PRODUCING A SPINAL COLUMN IMPLANT |
US20230210666A1 (en) * | 2020-05-29 | 2023-07-06 | Kyocera Corporation | Artificial joint stem |
Family Cites Families (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2987758B2 (ja) * | 1996-03-22 | 1999-12-06 | 株式会社ブレーンベース | インプラント及びその製造方法 |
JP4091728B2 (ja) * | 2000-03-27 | 2008-05-28 | 京セラ株式会社 | 生体インプラント材とその製法 |
US6596338B2 (en) | 2001-10-24 | 2003-07-22 | Howmedica Osteonics Corp. | Antibiotic calcium phosphate coating |
JP4116791B2 (ja) * | 2001-12-13 | 2008-07-09 | 日本特殊陶業株式会社 | 水和硬化型リン酸カルシウムペーストの硬化時間制御方法 |
JP5069888B2 (ja) | 2006-09-19 | 2012-11-07 | 国立大学法人佐賀大学 | 生体インプラント |
WO2008029612A1 (fr) * | 2006-09-08 | 2008-03-13 | Japan Medical Materials Corporation | Bio-implant |
DE102008057026A1 (de) * | 2007-11-12 | 2009-05-28 | Medicoat Ag | Implantat und Verfahren zur Beschichtung eines Implantats |
EP2268327B1 (en) * | 2008-02-29 | 2019-05-29 | Smith & Nephew, Inc. | Coating and coating method |
JP2012040194A (ja) * | 2010-08-19 | 2012-03-01 | Saga Univ | 生体インプラント |
-
2013
- 2013-01-16 US US14/376,183 patent/US20150018965A1/en not_active Abandoned
- 2013-01-16 EP EP13743971.7A patent/EP2810665B1/en active Active
- 2013-01-16 WO PCT/JP2013/050661 patent/WO2013114947A1/ja active Application Filing
- 2013-01-16 JP JP2013556300A patent/JP6192014B2/ja active Active
-
2017
- 2017-05-01 JP JP2017091356A patent/JP6289708B2/ja active Active
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2021049494A1 (ja) | 2019-09-11 | 2021-03-18 | 京セラ株式会社 | 生体インプラント、および生体インプラントの製造方法 |
Also Published As
Publication number | Publication date |
---|---|
JP2017127744A (ja) | 2017-07-27 |
US20150018965A1 (en) | 2015-01-15 |
EP2810665A4 (en) | 2015-09-09 |
EP2810665A1 (en) | 2014-12-10 |
JPWO2013114947A1 (ja) | 2015-05-11 |
JP6289708B2 (ja) | 2018-03-07 |
WO2013114947A1 (ja) | 2013-08-08 |
EP2810665B1 (en) | 2020-10-14 |
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