ES2589677T3 - Estabilización tras haz de electrones de dispositivos médicos poliméricos - Google Patents
Estabilización tras haz de electrones de dispositivos médicos poliméricos Download PDFInfo
- Publication number
- ES2589677T3 ES2589677T3 ES11752001.5T ES11752001T ES2589677T3 ES 2589677 T3 ES2589677 T3 ES 2589677T3 ES 11752001 T ES11752001 T ES 11752001T ES 2589677 T3 ES2589677 T3 ES 2589677T3
- Authority
- ES
- Spain
- Prior art keywords
- temperature
- stent
- polymer
- exposure
- radiation
- 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.)
- Active
Links
- 238000010894 electron beam technology Methods 0.000 title claims description 20
- 230000006641 stabilisation Effects 0.000 title description 7
- 238000011105 stabilization Methods 0.000 title description 7
- 229920000642 polymer Polymers 0.000 claims abstract description 99
- 150000003254 radicals Chemical class 0.000 claims abstract description 56
- 238000000034 method Methods 0.000 claims abstract description 28
- 230000001954 sterilising effect Effects 0.000 claims abstract description 24
- 238000004659 sterilization and disinfection Methods 0.000 claims abstract description 21
- 230000007423 decrease Effects 0.000 claims abstract description 11
- 238000000354 decomposition reaction Methods 0.000 claims abstract description 9
- 239000013078 crystal Substances 0.000 claims abstract description 7
- 238000002144 chemical decomposition reaction Methods 0.000 claims abstract description 5
- 238000012986 modification Methods 0.000 claims abstract description 4
- 230000004048 modification Effects 0.000 claims abstract description 4
- 230000008034 disappearance Effects 0.000 claims abstract description 3
- 230000000087 stabilizing effect Effects 0.000 claims abstract description 3
- 229920001432 poly(L-lactide) Polymers 0.000 claims description 21
- 230000005855 radiation Effects 0.000 claims description 20
- 230000009477 glass transition Effects 0.000 claims description 7
- 206010073306 Exposure to radiation Diseases 0.000 abstract description 11
- 238000010438 heat treatment Methods 0.000 description 24
- 239000000463 material Substances 0.000 description 17
- 238000011282 treatment Methods 0.000 description 10
- 238000002513 implantation Methods 0.000 description 9
- 238000004519 manufacturing process Methods 0.000 description 9
- 238000006243 chemical reaction Methods 0.000 description 7
- 238000003776 cleavage reaction Methods 0.000 description 7
- 230000008569 process Effects 0.000 description 7
- 230000035882 stress Effects 0.000 description 7
- 230000009467 reduction Effects 0.000 description 6
- 230000007017 scission Effects 0.000 description 6
- 210000004204 blood vessel Anatomy 0.000 description 5
- 230000036760 body temperature Effects 0.000 description 5
- 230000015556 catabolic process Effects 0.000 description 5
- 239000011248 coating agent Substances 0.000 description 5
- 238000000576 coating method Methods 0.000 description 5
- 230000006835 compression Effects 0.000 description 5
- 238000007906 compression Methods 0.000 description 5
- 238000006731 degradation reaction Methods 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 229940079593 drug Drugs 0.000 description 5
- 238000012545 processing Methods 0.000 description 5
- 208000037803 restenosis Diseases 0.000 description 5
- 238000003860 storage Methods 0.000 description 5
- 239000000126 substance Substances 0.000 description 5
- 229920001244 Poly(D,L-lactide) Polymers 0.000 description 4
- 230000002411 adverse Effects 0.000 description 4
- 238000013461 design Methods 0.000 description 4
- 229910052751 metal Inorganic materials 0.000 description 4
- 239000002184 metal Substances 0.000 description 4
- 238000007669 thermal treatment Methods 0.000 description 4
- 208000031481 Pathologic Constriction Diseases 0.000 description 3
- 238000002399 angioplasty Methods 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002844 melting Methods 0.000 description 3
- 230000008018 melting Effects 0.000 description 3
- 229920006126 semicrystalline polymer Polymers 0.000 description 3
- 230000036262 stenosis Effects 0.000 description 3
- 208000037804 stenosis Diseases 0.000 description 3
- 230000002792 vascular Effects 0.000 description 3
- 239000013543 active substance Substances 0.000 description 2
- 229910052782 aluminium Inorganic materials 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 238000000137 annealing Methods 0.000 description 2
- 238000001815 biotherapy Methods 0.000 description 2
- 229920001400 block copolymer Polymers 0.000 description 2
- 210000001124 body fluid Anatomy 0.000 description 2
- 239000010839 body fluid Substances 0.000 description 2
- 238000005336 cracking Methods 0.000 description 2
- 238000002788 crimping Methods 0.000 description 2
- 238000002425 crystallisation Methods 0.000 description 2
- 230000008025 crystallization Effects 0.000 description 2
- 238000005520 cutting process Methods 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 238000001125 extrusion Methods 0.000 description 2
- 238000003698 laser cutting Methods 0.000 description 2
- 238000007726 management method Methods 0.000 description 2
- 244000005700 microbiome Species 0.000 description 2
- 238000004806 packaging method and process Methods 0.000 description 2
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 description 2
- 229920001610 polycaprolactone Polymers 0.000 description 2
- 239000004632 polycaprolactone Substances 0.000 description 2
- 239000000622 polydioxanone Substances 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 229920000166 polytrimethylene carbonate Polymers 0.000 description 2
- 239000007787 solid Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- 241000894007 species Species 0.000 description 2
- 230000008728 vascular permeability Effects 0.000 description 2
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 description 1
- ZMKVBUOZONDYBW-UHFFFAOYSA-N 1,6-dioxecane-2,5-dione Chemical compound O=C1CCC(=O)OCCCCO1 ZMKVBUOZONDYBW-UHFFFAOYSA-N 0.000 description 1
- JJTUDXZGHPGLLC-IMJSIDKUSA-N 4511-42-6 Chemical compound C[C@@H]1OC(=O)[C@H](C)OC1=O JJTUDXZGHPGLLC-IMJSIDKUSA-N 0.000 description 1
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 1
- HKVAMNSJSFKALM-GKUWKFKPSA-N Everolimus Chemical compound C1C[C@@H](OCCO)[C@H](OC)C[C@@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 HKVAMNSJSFKALM-GKUWKFKPSA-N 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 229920000954 Polyglycolide Polymers 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 238000007259 addition reaction Methods 0.000 description 1
- 230000032683 aging Effects 0.000 description 1
- 230000004075 alteration Effects 0.000 description 1
- 229920006125 amorphous polymer Polymers 0.000 description 1
- 239000012300 argon atmosphere Substances 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 230000003143 atherosclerotic effect Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 210000000013 bile duct Anatomy 0.000 description 1
- 239000012867 bioactive agent Substances 0.000 description 1
- 239000012620 biological material Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000005266 casting Methods 0.000 description 1
- 210000001175 cerebrospinal fluid Anatomy 0.000 description 1
- 238000003486 chemical etching Methods 0.000 description 1
- 238000012669 compression test Methods 0.000 description 1
- 238000004132 cross linking Methods 0.000 description 1
- 229920006237 degradable polymer Polymers 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 238000002845 discoloration Methods 0.000 description 1
- 238000010494 dissociation reaction Methods 0.000 description 1
- 230000005593 dissociations Effects 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 229960005167 everolimus Drugs 0.000 description 1
- 230000005284 excitation Effects 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 210000003709 heart valve Anatomy 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 238000007654 immersion Methods 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 239000011261 inert gas Substances 0.000 description 1
- 230000036512 infertility Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 238000010884 ion-beam technique Methods 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 229920001684 low density polyethylene Polymers 0.000 description 1
- 239000004702 low-density polyethylene Substances 0.000 description 1
- 238000003754 machining Methods 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 150000002739 metals Chemical class 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 238000007254 oxidation reaction Methods 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 230000005298 paramagnetic effect Effects 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920000071 poly(4-hydroxybutyrate) Polymers 0.000 description 1
- 229920002643 polyglutamic acid Polymers 0.000 description 1
- -1 polymandelide (PM) Polymers 0.000 description 1
- 238000003672 processing method Methods 0.000 description 1
- 238000007634 remodeling Methods 0.000 description 1
- 238000000807 solvent casting Methods 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 238000004804 winding Methods 0.000 description 1
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
- 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
-
- 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
Landscapes
- 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)
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 |
| US860681 | 2010-08-20 | ||
| PCT/US2011/047974 WO2012024328A2 (en) | 2010-08-20 | 2011-08-16 | Post electron beam stabilization of polymeric medical devices |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2589677T3 true ES2589677T3 (es) | 2016-11-15 |
Family
ID=44545925
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES11752001.5T Active ES2589677T3 (es) | 2010-08-20 | 2011-08-16 | Estabilización tras haz de electrones de dispositivos médicos poliméricos |
Country Status (6)
| Country | Link |
|---|---|
| US (2) | US8715569B2 (enExample) |
| EP (1) | EP2605807B1 (enExample) |
| JP (1) | JP6183808B2 (enExample) |
| CN (1) | CN103118715B (enExample) |
| ES (1) | ES2589677T3 (enExample) |
| WO (1) | WO2012024328A2 (enExample) |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8206635B2 (en) | 2008-06-20 | 2012-06-26 | Amaranth Medical Pte. | Stent fabrication via tubular casting processes |
| US10898620B2 (en) | 2008-06-20 | 2021-01-26 | Razmodics Llc | Composite stent having multi-axial flexibility and method of manufacture thereof |
| 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 |
| US11534508B2 (en) | 2017-02-08 | 2022-12-27 | Mitsubishi Gas Chemical Company, Inc. | Method for producing sterilized oxygen-absorbing multilayer body |
| JP7263338B2 (ja) | 2017-10-23 | 2023-04-24 | エボニック コーポレイション | ポリエステルの滅菌工程のための方法および装置 |
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 |
| US8012402B2 (en) | 2008-08-04 | 2011-09-06 | Abbott Cardiovascular Systems Inc. | Tube expansion process for semicrystalline polymers to maximize fracture toughness |
| US7971333B2 (en) | 2006-05-30 | 2011-07-05 | Advanced Cardiovascular Systems, Inc. | Manufacturing process for polymetric stents |
| 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 JP JP2013525981A patent/JP6183808B2/ja not_active Expired - Fee Related
- 2011-08-16 EP EP11752001.5A patent/EP2605807B1/en not_active Not-in-force
- 2011-08-16 ES ES11752001.5T patent/ES2589677T3/es active Active
- 2011-08-16 WO PCT/US2011/047974 patent/WO2012024328A2/en not_active Ceased
- 2011-08-16 CN CN201180045244.6A patent/CN103118715B/zh not_active Expired - Fee Related
-
2014
- 2014-04-30 US US14/266,717 patent/US9278147B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| US20140234164A1 (en) | 2014-08-21 |
| CN103118715B (zh) | 2014-11-26 |
| CN103118715A (zh) | 2013-05-22 |
| US8715569B2 (en) | 2014-05-06 |
| US20120045362A1 (en) | 2012-02-23 |
| WO2012024328A2 (en) | 2012-02-23 |
| JP2013540462A (ja) | 2013-11-07 |
| US9278147B2 (en) | 2016-03-08 |
| EP2605807B1 (en) | 2016-04-20 |
| HK1186132A1 (zh) | 2014-03-07 |
| WO2012024328A3 (en) | 2012-07-19 |
| JP6183808B2 (ja) | 2017-08-23 |
| EP2605807A2 (en) | 2013-06-26 |
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