CN105167891B - 使聚合物支架的分子量在灭菌后稳定的方法 - Google Patents

使聚合物支架的分子量在灭菌后稳定的方法 Download PDF

Info

Publication number
CN105167891B
CN105167891B CN201510564607.7A CN201510564607A CN105167891B CN 105167891 B CN105167891 B CN 105167891B CN 201510564607 A CN201510564607 A CN 201510564607A CN 105167891 B CN105167891 B CN 105167891B
Authority
CN
China
Prior art keywords
support
skeleton
polymer
gas
oxygen
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
Application number
CN201510564607.7A
Other languages
English (en)
Chinese (zh)
Other versions
CN105167891A (zh
Inventor
王云兵
德里克·莫尔蒂森
马潇
汤富为
拜伦·兰贝特
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Cardiovascular Systems Inc
Original Assignee
Abbott Cardiovascular Systems Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Abbott Cardiovascular Systems Inc filed Critical Abbott Cardiovascular Systems Inc
Publication of CN105167891A publication Critical patent/CN105167891A/zh
Application granted granted Critical
Publication of CN105167891B publication Critical patent/CN105167891B/zh
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61F2/0095—Packages or dispensers for prostheses or other 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
    • A61L2/00—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/087—Particle radiation, e.g. electron-beam, alpha or beta radiation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C71/00—After-treatment of articles without altering their shape; Apparatus therefor
    • B29C71/009—After-treatment of articles without altering their shape; Apparatus therefor using gases without chemical reaction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C71/00—After-treatment of articles without altering their shape; Apparatus therefor
    • B29C71/04—After-treatment of articles without altering their shape; Apparatus therefor by wave energy or particle radiation, e.g. for curing or vulcanising preformed articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B55/00—Preserving, protecting or purifying packages or package contents in association with packaging
    • B65B55/02—Sterilising, e.g. of complete packages
    • B65B55/12—Sterilising contents prior to, or during, packaging
    • B65B55/16—Sterilising contents prior to, or during, packaging by irradiation
    • 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
    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/081—Gamma 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—Disinfection or sterilisation of materials or objects, in general; Accessories therefor
    • A61L2/02—Disinfection or sterilisation of materials or objects, in general; Accessories therefor using physical processes
    • A61L2/08—Radiation
    • A61L2/082—X-rays
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
    • B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
    • B29C35/08—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation
    • B29C35/0866—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using particle radiation
    • B29C2035/0877—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould by wave energy or particle radiation using particle radiation using electron radiation, e.g. beta-rays

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Epidemiology (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Plasma & Fusion (AREA)
  • Mechanical Engineering (AREA)
  • Toxicology (AREA)
  • Materials For Medical Uses (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
CN201510564607.7A 2011-05-09 2012-05-08 使聚合物支架的分子量在灭菌后稳定的方法 Active CN105167891B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US13/103,890 2011-05-09
US13/103,890 US8966868B2 (en) 2011-05-09 2011-05-09 Methods of stabilizing molecular weight of polymer stents after sterilization
CN201280029276.1A CN103619365B (zh) 2011-05-09 2012-05-08 使聚合物支架的分子量在灭菌后稳定的方法

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201280029276.1A Division CN103619365B (zh) 2011-05-09 2012-05-08 使聚合物支架的分子量在灭菌后稳定的方法

Publications (2)

Publication Number Publication Date
CN105167891A CN105167891A (zh) 2015-12-23
CN105167891B true CN105167891B (zh) 2017-10-03

Family

ID=46147733

Family Applications (2)

Application Number Title Priority Date Filing Date
CN201510564607.7A Active CN105167891B (zh) 2011-05-09 2012-05-08 使聚合物支架的分子量在灭菌后稳定的方法
CN201280029276.1A Active CN103619365B (zh) 2011-05-09 2012-05-08 使聚合物支架的分子量在灭菌后稳定的方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201280029276.1A Active CN103619365B (zh) 2011-05-09 2012-05-08 使聚合物支架的分子量在灭菌后稳定的方法

Country Status (5)

Country Link
US (3) US8966868B2 (enExample)
EP (1) EP2707045A1 (enExample)
JP (2) JP6139512B2 (enExample)
CN (2) CN105167891B (enExample)
WO (1) WO2012154753A1 (enExample)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9078740B2 (en) 2013-01-21 2015-07-14 Howmedica Osteonics Corp. Instrumentation and method for positioning and securing a graft
US9681951B2 (en) 2013-03-14 2017-06-20 Edwards Lifesciences Cardiaq Llc Prosthesis with outer skirt and anchors
WO2015119976A1 (en) * 2014-02-04 2015-08-13 Abbott Cardiovascular Systems Inc. Modified pla polymer and method of making and using
US11090411B2 (en) * 2016-01-28 2021-08-17 Warsaw Orthopedic, Inc. Electron beam irradiated osteoinductive bone implant
EP3619136B1 (en) 2017-05-02 2021-04-21 Medtronic Vascular Inc. Packaging for dry tissue prosthetic heart valve
EP3619135B1 (en) 2017-05-02 2021-04-21 Medtronic Vascular Inc. Method and assembly for sterilizing a wet stored prosthetic heart valve
WO2022140351A1 (en) * 2020-12-21 2022-06-30 Sartorius Stedim Fmt Sas Method of measuring irradiation dose at a product level

Family Cites Families (39)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3798053A (en) * 1971-03-30 1974-03-19 Brien O Corp Control of atmospheric composition during radiation curing
US4710524A (en) * 1983-10-26 1987-12-01 Becton, Dickinson And Company High energy radiation stabilization of semi-crystalline polymers
US4952482A (en) * 1987-08-03 1990-08-28 Hoechst Calanese Corporation Method of imaging oxygen resistant radiation polymerizable composition and element containing a photopolymer composition
US5252694A (en) * 1992-01-22 1993-10-12 Minnesota Mining And Manufacturing Company Energy-polymerization adhesive, coating, film and process for making the same
US5414049A (en) * 1993-06-01 1995-05-09 Howmedica Inc. Non-oxidizing polymeric medical implant
PL189246B1 (pl) * 1996-02-13 2005-07-29 Gen Hospital Corp Sposób otrzymywania usieciowanego polietylenu o ultrawysokim ciężarze cząsteczkowym, medyczna proteza do stosowania wewnątrz ciała oraz zastosowanie poddanego działaniu promieniowania polietylenu o ultrawysokim ciężarze cząsteczkowym
CN1241084C (zh) * 2000-07-21 2006-02-08 惠普公司 用于按要求的安全文档打印的两极加密高速缓存
US20030208278A1 (en) * 2000-09-29 2003-11-06 Robert Richard Supercritical fluid treatment of irradiated polyethylene
US6547828B2 (en) * 2001-02-23 2003-04-15 Smith & Nephew, Inc. Cross-linked ultra-high molecular weight polyethylene for medical implant use
US20030016457A1 (en) * 2001-07-20 2003-01-23 The United States Of America Represented By The Secretary Of The Navy Lightweight parabolic mirror
US20030095890A1 (en) * 2001-09-24 2003-05-22 Shirley Miekka Methods for sterilizing biological materials containing non-aqueous solvents
WO2003049930A1 (en) * 2001-12-12 2003-06-19 Depuy Products, Inc. Orthopaedic device and method for making same
GB0222846D0 (en) * 2002-10-03 2002-11-06 Choo Yen Cell culture
US7214764B2 (en) * 2003-06-30 2007-05-08 Depuy Products, Inc. Free radical quench process for irradiated ultrahigh molecular weight polyethylene
US6919625B2 (en) * 2003-07-10 2005-07-19 General Semiconductor, Inc. Surface mount multichip devices
US6996952B2 (en) * 2003-09-30 2006-02-14 Codman & Shurtleff, Inc. Method for improving stability and effectivity of a drug-device combination product
JP2007512908A (ja) * 2003-12-01 2007-05-24 アドヴァンスド カーディオヴァスキュラー システムズ, インコーポレイテッド 温度調整式圧着法
JP2005169008A (ja) * 2003-12-15 2005-06-30 Nipro Corp 生体適合性材料の滅菌方法
AU2005209868B8 (en) * 2004-02-03 2010-06-03 The General Hospital Corporation Dba Massachusetts General Hospital Highly crystalline cross-linked oxidation-resistant polyethylene
AU2005244062B8 (en) * 2004-05-11 2010-08-05 Cambridge Polymer Group, Inc. Methods for making oxidation resistant polymeric material
US7971333B2 (en) 2006-05-30 2011-07-05 Advanced Cardiovascular Systems, Inc. Manufacturing process for polymetric stents
US7335697B2 (en) * 2004-12-23 2008-02-26 Depuy Products, Inc. Polymer composition comprising cross-linked polyethylene and methods for making the same
US8394446B2 (en) * 2005-07-25 2013-03-12 Abbott Cardiovascular Systems Inc. Methods of providing antioxidants to implantable medical devices
US7785647B2 (en) * 2005-07-25 2010-08-31 Advanced Cardiovascular Systems, Inc. Methods of providing antioxidants to a drug containing product
ATE529464T1 (de) * 2005-08-22 2011-11-15 Gen Hospital Corp Dba Massachusetts General Hospital Oxidationsbeständiges homogenisiertes polymermaterial
US8034287B2 (en) * 2006-06-01 2011-10-11 Abbott Cardiovascular Systems Inc. Radiation sterilization of medical devices
EP2110002B1 (en) * 2007-01-25 2012-04-25 The General Hospital Corporation Methods for making oxidation-resistant cross-linked polymeric materials
CA2679274C (en) * 2007-03-02 2018-02-20 The General Hospital Corporation Cross-linking of antioxidant-containing polymers
US8002817B2 (en) 2007-05-04 2011-08-23 Abbott Cardiovascular Systems Inc. Stents with high radial strength and methods of manufacturing same
US8388673B2 (en) 2008-05-02 2013-03-05 Abbott Cardiovascular Systems Inc. Polymeric stent
US8147769B1 (en) * 2007-05-16 2012-04-03 Abbott Cardiovascular Systems Inc. Stent and delivery system with reduced chemical degradation
US7959857B2 (en) * 2007-06-01 2011-06-14 Abbott Cardiovascular Systems Inc. Radiation sterilization of medical devices
CN101688004B (zh) * 2007-06-29 2013-11-20 巴塞尔聚烯烃意大利有限责任公司 含非酚稳定剂的受辐射聚合物组合物
WO2009045658A1 (en) * 2007-10-05 2009-04-09 The Brigham And Women's Hospital, Inc. Crosslinked polymers and methods of making the same
EP2427225B8 (en) * 2009-05-04 2017-03-22 Smith & Nephew, Inc Synergistic effects of blending multiple additives in uhmwpe
US9889238B2 (en) * 2009-07-21 2018-02-13 Abbott Cardiovascular Systems Inc. Biodegradable stent with adjustable degradation rate
US8207240B2 (en) * 2009-09-14 2012-06-26 Abbott Cardiovascular Systems Inc Method to minimize molecular weight drop of poly(L-lactide) stent during processing
US20110139650A1 (en) * 2009-12-15 2011-06-16 Amcor Flexibles, Inc. Sterilizable Package Having Breathable Membrane for the Packaging of Medical Devices
US9132209B2 (en) * 2010-05-07 2015-09-15 Howmedia Osteonics Corp. Surface crosslinked polyethylene

Also Published As

Publication number Publication date
EP2707045A1 (en) 2014-03-19
US20120285123A1 (en) 2012-11-15
WO2012154753A1 (en) 2012-11-15
US20150128527A1 (en) 2015-05-14
JP6375401B2 (ja) 2018-08-15
JP6139512B2 (ja) 2017-05-31
US20150137428A1 (en) 2015-05-21
JP2014514125A (ja) 2014-06-19
JP2017140398A (ja) 2017-08-17
US8966868B2 (en) 2015-03-03
CN103619365B (zh) 2015-09-30
CN103619365A (zh) 2014-03-05
CN105167891A (zh) 2015-12-23

Similar Documents

Publication Publication Date Title
JP6375401B2 (ja) 滅菌後のポリマーステントの分子量を安定化させる方法
US8858611B2 (en) Sterilization methods and apparatus
US6184265B1 (en) Low temperature pressure stabilization of implant component
CN103619568B (zh) 聚合物医疗装置的电子束后调节
JP2009543596A (ja) ステントの低温滅菌
US20060064160A1 (en) Implant of low radial strength
JP2012120854A (ja) 耐酸化性ポリマー物質の製造方法
Yakacki et al. Cytotoxicity and thermomechanical behavior of biomedical shape-memory polymer networks post-sterilization
Levy et al. Biodegradable inflatable balloon for reducing radiation adverse effects in prostate cancer
BRPI1012815B1 (pt) Método para esterilização de um dispositivo médico dotado de um revestimento de heparina
JP6183808B2 (ja) ポリマー製医療用装具の電子線後安定化
US20110281022A1 (en) Methods For Controlling The Release Rate And Improving The Mechanical Properties Of A Stent Coating
CN106474507A (zh) 一种提高聚合物支架药物涂层稳定性的灭菌工艺
US20100300045A1 (en) Method for storing a medical device
Zaikov et al. Biodegradation of polyolefins biomedical applications
Jahan et al. Free radical processes in medical grade UHMWPE
US20230372077A1 (en) Medical implants with nano surfaces
Silindir et al. The Effect of Radiation on a Variety of Pharmaceuticals and
Singh et al. Pharmaceuticals Polymers in Medicine
CN107865983A (zh) 一种药物支架及其制备方法

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
GR01 Patent grant
GR01 Patent grant