JP5393030B2 - 医療機器及び医療機器を製造する方法 - Google Patents
医療機器及び医療機器を製造する方法 Download PDFInfo
- Publication number
- JP5393030B2 JP5393030B2 JP2007532961A JP2007532961A JP5393030B2 JP 5393030 B2 JP5393030 B2 JP 5393030B2 JP 2007532961 A JP2007532961 A JP 2007532961A JP 2007532961 A JP2007532961 A JP 2007532961A JP 5393030 B2 JP5393030 B2 JP 5393030B2
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- Prior art keywords
- medical device
- device material
- antibacterial
- wound
- days
- 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
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/60—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like for external osteosynthesis, e.g. distractors, contractors
-
- 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
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—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
- A61L31/14—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
- 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
- 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
- A61L2300/406—Antibiotics
-
- 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
- A61L2300/45—Mixtures of two or more drugs, e.g. synergistic mixtures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/025—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body through bones or teeth, e.g. through the skull
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/02—Access sites
- A61M39/0247—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body
- A61M2039/0285—Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body with sterilisation means, e.g. antibacterial coatings, disinfecting pads, UV radiation LEDs or heating means in the port
Description
直径2.5cm及び厚さ3.5mmのシリコーンエラストマーのディスク形態の創傷保護材(例えば、カテーテル又は外部固定ピンの出口部位の保護のため)をリファンピン+クリンダマイシン(A)、リファンピン+クリンダマイシン+トリクロサン(B)又はトリクロサン単独(C)で含浸させた。その後、このディスクをオートクレーブにかけることによって滅菌させ、グラム陽性菌である黄色ブドウ球菌を播種した寒天プレート上に置いた。一晩インキュベート後、阻害された帯域を測定し、ディスクをさらに播種したプレートに移し、この帯域が見えなくなるまでこのプロセスを繰り返した。阻害された帯域の内側又はディスクの下部で増殖した任意の細菌コロニーのトリクロサンに対する最小発育阻止濃度(MIC)を測定し、元の接種材料とのこれらの同等性をパルスフィールドゲル電気泳動法で測定した。この結果は以下の通りであった。
カテーテルの出口部位/トラック感染の模擬試験において、リファンピン+クリンダマイシン+トリクロサンで含浸されたカテーテルを模擬試験「組織」(一般的な細菌栄養物質(bacterial nutrient)及びデキストロース及びpH指示薬を含む半流動寒天)に挿入して、「皮膚」の出口部位をブドウ球菌で毎日攻撃した。含浸していないカテーテルを対照として使用した(図8)。含浸していないカテーテルに関して、細菌増殖130を液体/気体界面及び隣接するカテーテルの外表面に見ることができた。この細菌増殖130は、紫色から黄色に寒天の色を変化させ、酸代謝物の生成によるpHの低下を示す。対して、含浸されたカテーテル(図9)では、出口部位での細菌増殖の兆候が示されず、カテーテル外部の下方へトラックするものは何も見ることができなかった。pHは全く変化しなかった(元の色である紫色)。
Claims (11)
- 抗菌剤の組み合わせで含浸される医療機器材料であって、該抗菌剤の組み合わせが、第1の抗菌剤としてトリクロサンと、第2の抗菌剤としてリファマイシンと、第3の抗菌剤としてトリメトプリム、リンコマイシン、及び、キノロンのいずれかと、を含み、連続プレート移送試験によって黄色ブドウ球菌及び大腸菌を測定した場合に、80日間以上の黄色ブドウ球菌及び大腸菌の抗菌活性及び耐性のある細菌の突然変異体の阻害を該機器材料に提供する、抗菌剤の組み合わせで含浸される医療機器材料。
- 前記抗菌剤の組み合わせが、90日間以上にわたって、抗菌活性及び耐性のある細菌の突然変異体の阻害を前記機器材料に提供する、請求項1に記載の医療機器材料。
- 前記抗菌剤の組み合わせが、100日間以上にわたって、抗菌活性及び耐性のある細菌の突然変異体の阻害を前記機器材料に提供する、請求項1に記載の医療機器材料。
- 前記抗菌剤の組み合わせが、120日間以上にわたって、抗菌活性及び耐性のある細菌の突然変異体の阻害を前記機器材料に提供する、請求項1に記載の医療機器材料。
- 前記抗菌剤の組み合わせが、140日間以上にわたって、抗菌活性及び耐性のある細菌の突然変異体の阻害を前記機器材料に提供する、請求項1に記載の医療機器材料。
- 前記抗菌剤の組み合わせが、160日間以上にわたって、抗菌活性及び耐性のある細菌の突然変異体の阻害を前記機器材料に提供する、請求項1に記載の医療機器材料。
- 前記抗菌剤の組み合わせが、190日間以上にわたって、抗菌活性及び耐性のある細菌の突然変異体の阻害を前記機器材料に提供する、請求項1に記載の医療機器材料。
- シリコーンエラストマー、ポリアルケン、ポリ塩化ビニルポリエチレンテレフタレート、ポリテトラフルオロエチレン(PTFE)、シリコーンポリウレタン共重合体、及びポリウレタンラテックスから選択されるポリマー材料を含む、請求項1〜6のいずれか1項に記載の医療機器材料。
- 請求項1〜7のいずれか1項に記載の医療機器材料を含む医療機器。
- 創傷保護材、脳室外ドレナージ機器、オンマヤ槽、髄腔内ポンプ、全体が埋め込まれる中心静脈カテーテル等の中心静脈カテーテル、腹水シャント、ペースメーカー、持続的携帯型腹膜カテーテル、ボイスプロテーゼ、血管グラフト、導尿カテーテル、及び、眼内レンズの1つである、請求項9に記載の医療機器。
- 経皮部を備える、請求項9又は請求項10に記載の医療機器。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GBGB0421164.5A GB0421164D0 (en) | 2004-09-23 | 2004-09-23 | Medical devices and methods of making medical devices |
GB0421164.5 | 2004-09-23 | ||
PCT/GB2005/003667 WO2006032904A2 (en) | 2004-09-23 | 2005-09-22 | Medical devices and methods of making medical devices |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2008513172A JP2008513172A (ja) | 2008-05-01 |
JP5393030B2 true JP5393030B2 (ja) | 2014-01-22 |
Family
ID=33397131
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2007532961A Expired - Fee Related JP5393030B2 (ja) | 2004-09-23 | 2005-09-22 | 医療機器及び医療機器を製造する方法 |
Country Status (6)
Country | Link |
---|---|
US (2) | US10500388B2 (ja) |
EP (3) | EP2272545B1 (ja) |
JP (1) | JP5393030B2 (ja) |
CA (1) | CA2580894C (ja) |
GB (1) | GB0421164D0 (ja) |
WO (1) | WO2006032904A2 (ja) |
Families Citing this family (20)
Publication number | Priority date | Publication date | Assignee | Title |
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US8414547B2 (en) * | 2004-04-29 | 2013-04-09 | C. R. Bard, Inc. | Modulating agents for antimicrobial coatings |
JP2009028150A (ja) * | 2007-07-25 | 2009-02-12 | National Cardiovascular Center | カフ部材及びカフ部材ユニット |
US9247973B2 (en) * | 2007-09-28 | 2016-02-02 | DePuy Synthes Products, Inc. | Anti-microbial implant |
EP2268332B1 (de) * | 2008-04-09 | 2019-01-16 | Aachen Scientific International PTE. LTD. | Verfahren zur erzeugung einer bioaktiven oberfläche auf einer endoprothese oder auf dem ballon eines ballonkatheters |
JP2010088792A (ja) * | 2008-10-10 | 2010-04-22 | National Cardiovascular Center | カフ部材及びカフ部材ユニット |
US9763697B2 (en) * | 2008-12-16 | 2017-09-19 | DePuy Synthes Products, Inc. | Anti-infective spinal rod with surface features |
US10045868B2 (en) * | 2009-03-04 | 2018-08-14 | W. L. Gore & Associates Inc. | Atraumatic vascular graft removal sheath |
US8326437B2 (en) * | 2009-03-04 | 2012-12-04 | W. L. Gore & Associates, Inc. | Atraumatic lead removal sheath |
US9078712B2 (en) * | 2009-04-15 | 2015-07-14 | Warsaw Orthopedic, Inc. | Preformed drug-eluting device to be affixed to an anterior spinal plate |
US8333791B2 (en) * | 2009-04-24 | 2012-12-18 | Warsaw Orthopedic, Inc. | Medical implant with tie configured to deliver a therapeutic substance |
US20100274295A1 (en) * | 2009-04-24 | 2010-10-28 | Warsaw Orthopedic, Inc. | Medical implant configured to deliver a therapeutic substance |
US8894613B2 (en) | 2011-01-22 | 2014-11-25 | Hideo Koike | Catheter attachment and method |
AU2013288698B2 (en) * | 2012-07-10 | 2018-01-18 | Bio Med Sciences, Inc. | Novel medical countermeasure for first responder use in burn injury |
AU2016374654B2 (en) * | 2015-12-24 | 2020-08-20 | Jason Jit-Sun Tan | Customisable stoma insert |
US11826277B2 (en) * | 2015-12-24 | 2023-11-28 | Jason Jit-sun Tan | Customizable stoma insert |
ES2641256B1 (es) * | 2016-04-07 | 2018-10-22 | Fundación Para La Investigación Del Hospital Universitario Y Politecnico La Fe De La Comunidad Valenciana | Dispositivo de fijación y protección de drenajes o filamentos intracraneales |
WO2018141783A1 (de) | 2017-01-31 | 2018-08-09 | Schierholz Joerg Michael | Katheteransatz aus kunststoff enthaltend molekular-dispers verteiltes polychloriertes phenoxyphenol (pcpp) |
CN109423489B (zh) * | 2017-08-28 | 2021-11-23 | 江苏食品药品职业技术学院 | 一种连续式微生物物理诱变育种方法 |
NL2021630B1 (en) | 2018-09-14 | 2020-05-06 | Stichting Katholieke Univ | Polyurethane sheet |
WO2020043834A1 (en) | 2018-08-30 | 2020-03-05 | Stichting Katholieke Universiteit | Polyurethane sheet |
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EP0164896B1 (en) * | 1984-05-25 | 1989-02-01 | Thermedics, Inc. | Percutaneous access device |
CA1245931A (en) * | 1984-09-21 | 1988-12-06 | Sophia Pesotchinsky | Positionable tissue interfacing device for the management of percutaneous conduits |
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US4946444A (en) * | 1988-11-23 | 1990-08-07 | Clemson University | Percutaneous devices with flanges of variable stiffness |
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US5772640A (en) * | 1996-01-05 | 1998-06-30 | The Trustees Of Columbia University Of The City Of New York | Triclosan-containing medical devices |
US5848992A (en) * | 1997-03-07 | 1998-12-15 | Hart; Charles C. | Superfascial surgical access device |
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DE19912459C2 (de) * | 1999-03-19 | 2001-02-22 | Disetronic Licensing Ag | Medizinische Durchlaßvorrichtung zur subkutanen Injektion |
US6224579B1 (en) * | 1999-03-31 | 2001-05-01 | The Trustees Of Columbia University In The City Of New York | Triclosan and silver compound containing medical devices |
US6635676B2 (en) * | 1999-04-28 | 2003-10-21 | Regents Of The University Of Michigan | Non-toxic antimicrobial compositions and methods of use |
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US7306580B2 (en) * | 2003-04-16 | 2007-12-11 | Cook Incorporated | Medical device with therapeutic agents |
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-
2004
- 2004-09-23 GB GBGB0421164.5A patent/GB0421164D0/en not_active Ceased
-
2005
- 2005-09-22 JP JP2007532961A patent/JP5393030B2/ja not_active Expired - Fee Related
- 2005-09-22 CA CA2580894A patent/CA2580894C/en not_active Expired - Fee Related
- 2005-09-22 EP EP10178080.7A patent/EP2272545B1/en active Active
- 2005-09-22 EP EP10178073.2A patent/EP2289574B1/en not_active Not-in-force
- 2005-09-22 EP EP05781960.9A patent/EP1804845B1/en active Active
- 2005-09-22 WO PCT/GB2005/003667 patent/WO2006032904A2/en active Application Filing
-
2007
- 2007-03-23 US US11/690,567 patent/US10500388B2/en active Active
-
2017
- 2017-06-23 US US15/631,566 patent/US20170354813A1/en not_active Abandoned
Also Published As
Publication number | Publication date |
---|---|
US10500388B2 (en) | 2019-12-10 |
GB0421164D0 (en) | 2004-10-27 |
EP2272545B1 (en) | 2019-11-06 |
JP2008513172A (ja) | 2008-05-01 |
EP1804845B1 (en) | 2018-09-12 |
US20170354813A1 (en) | 2017-12-14 |
EP2289574A2 (en) | 2011-03-02 |
EP2289574A3 (en) | 2014-07-02 |
CA2580894C (en) | 2013-06-25 |
CA2580894A1 (en) | 2006-03-30 |
EP2272545A2 (en) | 2011-01-12 |
WO2006032904A2 (en) | 2006-03-30 |
EP2289574B1 (en) | 2019-07-17 |
EP1804845A2 (en) | 2007-07-11 |
US20070224243A1 (en) | 2007-09-27 |
WO2006032904A3 (en) | 2006-10-26 |
EP2272545A3 (en) | 2014-11-12 |
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