JP6183808B2 - ポリマー製医療用装具の電子線後安定化 - Google Patents
ポリマー製医療用装具の電子線後安定化 Download PDFInfo
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- JP6183808B2 JP6183808B2 JP2013525981A JP2013525981A JP6183808B2 JP 6183808 B2 JP6183808 B2 JP 6183808B2 JP 2013525981 A JP2013525981 A JP 2013525981A JP 2013525981 A JP2013525981 A JP 2013525981A JP 6183808 B2 JP6183808 B2 JP 6183808B2
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- stent
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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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
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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
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/087—Particle radiation, e.g. electron-beam, alpha or beta radiation
-
- 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
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
-
- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
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- Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Materials For Medical Uses (AREA)
- Medicinal Chemistry (AREA)
- Polymers & Plastics (AREA)
- Organic Chemistry (AREA)
Description
[発明の分野]
本発明は、生体吸収性ポリマーからステントを作製する方法に関する。
本発明は、生体の管腔に埋め込むように構成された、半径方向(radially)に拡張可能な体内補綴物に関する。「体内補綴物」とは、生体内に置かれる人工装具に相当する。「管腔」とは、血管などの管状器官の空洞を指す。ステントは、こうした体内補綴物の一例である。ステントは、開いた状態を保ち、血管の一部分又は尿路及び胆管などの他の解剖組織上の管腔を時には拡張するように機能する、一般に円筒形状の装具である。ステントは、血管中のアテローム硬化性狭窄症の処置に使用されることが多い。「狭窄症」は、生体の流通又は開口部(orifice)の狭小化又は狭窄を指す。そうした処置では、ステントは生体の血管を強化して、脈管系における血管形成術後の再狭窄を防ぐ。「再狭窄」とは、(バルーン血管形成、ステント処置、又は弁形成によるもののように)処置に明らかな成功をおさめた後、血管又は心臓弁中に狭窄が再発生することを指す。
本発明の様々な実施形態には、放射線曝露によりポリマー製ステントを殺菌するステップであって、上記放射線曝露によりポリマー中に遊離ラジカルが生成するステップと、上記ステントを周囲よりも高い温度に曝露して上記ステントの温度を上昇させるステップであって、温度上昇により遊離ラジカル濃度が低下し、遊離ラジカルの消失を導く遊離ラジカルの減衰速度が増加して、これにより、殺菌による上記ポリマーの化学的分解が低減するステップとを含む、ステントの安定化方法が含まれる。
本発明の実施形態は、電子線(e線)殺菌後の、ステントなどのポリマー製埋込式医療用装具の安定化に関する。より一般には、本発明の実施形態はまた、以下に限定されないが、自己拡張型ステント、バルーン拡張型ステント、ステント移植片、脈管移植片、脳脊髄液シャント、又は一般に管状の埋込式医療用装具を含む装具にも使用することができる。
周囲温度は、20〜30℃の間の任意の温度に相当することができる。
開示した範囲はすべて、範囲の端点を含む。
「ガラス転移温度」(Tg)は、ポリマーのアモルファス領域が、脆弱なガラス質状態から、変形可能又は延性の固体状態に大気圧で変化する温度である。言いかえれば、Tgはポリマー鎖における部分的な動きを開始する温度に相当する。所与のポリマーのTgは、加熱速度に依存することができ、ポリマーの熱履歴によって影響を受け得る。さらに、ポリマーの化学構造は、可動性に影響することによって、ガラス転移にかなり影響を及ぼす。
Claims (1)
- 放射線曝露によりポリマー(脂環式構造含有炭化水素重合体を除く)製ステントを殺菌するステップであって、前記放射線曝露により前記ポリマー中に遊離ラジカルが生成するステップと、
前記ステントを周囲よりも高く前記ポリマーのTgよりも低い温度に曝露して前記ステントの温度を上昇させるステップであって、温度上昇により遊離ラジカル濃度が低下し、遊離ラジカルの消失を導く遊離ラジカルの減衰速度が増加し、これにより、殺菌による前記ポリマーの化学的分解が低減する一方、結晶化度、結晶サイズ、及び、ポリマー鎖の配向の変化を抑制又は防止するステップと、
を含み、
前記ポリマーは、生体再吸収性及び生体吸収性ポリマーのうちの1種又は組合せである、ステントの安定化方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/860,681 US8715569B2 (en) | 2010-08-20 | 2010-08-20 | Post electron beam stabilization of polymeric medical devices |
US12/860,681 | 2010-08-20 | ||
PCT/US2011/047974 WO2012024328A2 (en) | 2010-08-20 | 2011-08-16 | Post electron beam stabilization of polymeric medical devices |
Publications (3)
Publication Number | Publication Date |
---|---|
JP2013540462A JP2013540462A (ja) | 2013-11-07 |
JP2013540462A5 JP2013540462A5 (ja) | 2014-10-02 |
JP6183808B2 true JP6183808B2 (ja) | 2017-08-23 |
Family
ID=44545925
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013525981A Expired - Fee Related JP6183808B2 (ja) | 2010-08-20 | 2011-08-16 | ポリマー製医療用装具の電子線後安定化 |
Country Status (7)
Country | Link |
---|---|
US (2) | US8715569B2 (ja) |
EP (1) | EP2605807B1 (ja) |
JP (1) | JP6183808B2 (ja) |
CN (1) | CN103118715B (ja) |
ES (1) | ES2589677T3 (ja) |
HK (1) | HK1186132A1 (ja) |
WO (1) | WO2012024328A2 (ja) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10898620B2 (en) | 2008-06-20 | 2021-01-26 | Razmodics Llc | Composite stent having multi-axial flexibility and method of manufacture thereof |
US8206635B2 (en) | 2008-06-20 | 2012-06-26 | Amaranth Medical Pte. | Stent fabrication via tubular casting processes |
US8206636B2 (en) | 2008-06-20 | 2012-06-26 | Amaranth Medical Pte. | Stent fabrication via tubular casting processes |
US8613880B2 (en) * | 2010-04-21 | 2013-12-24 | Abbott Cardiovascular Systems Inc. | Post electron beam conditioning of polymeric medical devices |
JP6935061B2 (ja) * | 2017-02-08 | 2021-09-15 | 三菱瓦斯化学株式会社 | 滅菌済み酸素吸収性多層体の製造方法 |
CA3079689A1 (en) | 2017-10-23 | 2019-05-02 | Evonik Corporation | Method and device for a polyester sterilization process |
Family Cites Families (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS6274364A (ja) | 1985-09-27 | 1987-04-06 | 株式会社 ニツシヨ− | 医療用具 |
US5414049A (en) * | 1993-06-01 | 1995-05-09 | Howmedica Inc. | Non-oxidizing polymeric medical implant |
JP3787993B2 (ja) | 1997-10-27 | 2006-06-21 | 株式会社Nhvコーポレーション | 電子線照射装置 |
JP3785473B2 (ja) * | 1998-06-22 | 2006-06-14 | 日本ゼオン株式会社 | 放射線滅菌法および滅菌した成形品 |
JP2000334028A (ja) | 1999-05-26 | 2000-12-05 | Ishikawajima Harima Heavy Ind Co Ltd | 医療用品の電子線による滅菌方法 |
US7807211B2 (en) | 1999-09-03 | 2010-10-05 | Advanced Cardiovascular Systems, Inc. | Thermal treatment of an implantable medical device |
US7150853B2 (en) | 2001-11-01 | 2006-12-19 | Advanced Cardiovascular Systems, Inc. | Method of sterilizing a medical device |
US20050288481A1 (en) * | 2004-04-30 | 2005-12-29 | Desnoyer Jessica R | Design of poly(ester amides) for the control of agent-release from polymeric compositions |
US7971333B2 (en) | 2006-05-30 | 2011-07-05 | Advanced Cardiovascular Systems, Inc. | Manufacturing process for polymetric stents |
US8012402B2 (en) | 2008-08-04 | 2011-09-06 | Abbott Cardiovascular Systems Inc. | Tube expansion process for semicrystalline polymers to maximize fracture toughness |
US7694813B2 (en) | 2005-09-16 | 2010-04-13 | Poly-Med, Inc. | Package components for radiochemical sterilization |
WO2006034157A2 (en) | 2004-09-17 | 2006-03-30 | Poly-Med, Inc. | Package components for radiochemical sterilization |
US20070132155A1 (en) | 2005-12-13 | 2007-06-14 | Robert Burgermeister | Polymeric stent having modified molecular structures in selected regions of the hoops and method for increasing elongation at break |
US8034287B2 (en) * | 2006-06-01 | 2011-10-11 | Abbott Cardiovascular Systems Inc. | Radiation sterilization of medical devices |
US8747738B2 (en) * | 2006-08-15 | 2014-06-10 | Abbott Cardiovascular Systems Inc. | Sterilization methods for medical devices |
US20080169582A1 (en) | 2006-10-23 | 2008-07-17 | Vipul Bhupendra Dave | Method and apparatus for making polymeric drug delivery devices having differing morphological structures |
US8394317B2 (en) | 2008-08-11 | 2013-03-12 | Abbott Cardiovascular Systems Inc. | Method of improving fracture toughness of implantable medical devices through annealing |
-
2010
- 2010-08-20 US US12/860,681 patent/US8715569B2/en not_active Expired - Fee Related
-
2011
- 2011-08-16 CN CN201180045244.6A patent/CN103118715B/zh not_active Expired - Fee Related
- 2011-08-16 ES ES11752001.5T patent/ES2589677T3/es active Active
- 2011-08-16 EP EP11752001.5A patent/EP2605807B1/en not_active Not-in-force
- 2011-08-16 JP JP2013525981A patent/JP6183808B2/ja not_active Expired - Fee Related
- 2011-08-16 WO PCT/US2011/047974 patent/WO2012024328A2/en active Application Filing
-
2013
- 2013-12-09 HK HK13113660.7A patent/HK1186132A1/zh not_active IP Right Cessation
-
2014
- 2014-04-30 US US14/266,717 patent/US9278147B2/en not_active Expired - Fee Related
Also Published As
Publication number | Publication date |
---|---|
EP2605807A2 (en) | 2013-06-26 |
US20140234164A1 (en) | 2014-08-21 |
US20120045362A1 (en) | 2012-02-23 |
CN103118715B (zh) | 2014-11-26 |
ES2589677T3 (es) | 2016-11-15 |
HK1186132A1 (zh) | 2014-03-07 |
US8715569B2 (en) | 2014-05-06 |
CN103118715A (zh) | 2013-05-22 |
EP2605807B1 (en) | 2016-04-20 |
US9278147B2 (en) | 2016-03-08 |
WO2012024328A2 (en) | 2012-02-23 |
WO2012024328A3 (en) | 2012-07-19 |
JP2013540462A (ja) | 2013-11-07 |
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