US20110281022A1 - Methods For Controlling The Release Rate And Improving The Mechanical Properties Of A Stent Coating - Google Patents

Methods For Controlling The Release Rate And Improving The Mechanical Properties Of A Stent Coating Download PDF

Info

Publication number
US20110281022A1
US20110281022A1 US13/191,336 US201113191336A US2011281022A1 US 20110281022 A1 US20110281022 A1 US 20110281022A1 US 201113191336 A US201113191336 A US 201113191336A US 2011281022 A1 US2011281022 A1 US 2011281022A1
Authority
US
United States
Prior art keywords
radiation
coating
stent
mechanical properties
improving
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.)
Abandoned
Application number
US13/191,336
Inventor
Syed Faiyaz Ahmed Hossainy
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
Priority to US13/191,336 priority Critical patent/US20110281022A1/en
Publication of US20110281022A1 publication Critical patent/US20110281022A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/08Materials for coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L27/00Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers
    • C08L27/02Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L27/12Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers not modified by chemical after-treatment containing fluorine atoms
    • C08L27/20Homopolymers or copolymers of hexafluoropropene
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/602Type of release, e.g. controlled, sustained, slow

Definitions

  • the present invention is directed methods for controlling the release rate and improving the mechanical properties of a stent coating.
  • Improving the compositions from which medical articles, such as medical devices and coatings for medical devices, are produced is an ongoing goal of biomaterials research.
  • An example of such a medical device is an implantable medical device.
  • a stent is an example of an implantable medical device that can benefit from improvements such as, for example, a coating that can be used as a vehicle for delivering pharmaceutically active agents in a predictable manner.
  • Stents play an important role in a variety of medical procedures such as, for example, percutaneous transluminal coronary angioplasty (PTCA). Stents act as a mechanical intervention to physically hold open and, if desired, expand a passageway within a subject.
  • PTCA percutaneous transluminal coronary angioplasty
  • problems with the use of stents can include thrombosis and restenosis, which may develop several months after a particular procedure and create a need for additional angioplasty or a surgical by-pass operation.
  • stents are being developed to provide for the local delivery of agents, i.e., anti thrombotic and anti restenosis agents.
  • agents i.e., anti thrombotic and anti restenosis agents.
  • One method of local delivery includes coating the surface of a medical article, e.g., a stent, with a polymeric carrier and attaching an agent to, or blending it with, the polymeric carrier.
  • Agents can be used alone, and in combination.
  • the present invention provides such methods and is also directed to overcoming other deficiencies in the art.
  • the present invention relates to a method that involves exposing a stent coated with a drug and polymer to ionizing radiation, wherein the radiation acts to either increase or decrease the degree of cross-linking of the polymer. This method provides a means for controlling the drug release rate and improving the mechanical properties of a coating.
  • Another aspect of the present invention relates to a method for exposing a stent coated with everolimus and poly(vinylidene-co-hexafluoropropylene) (PVDF-HFP) to either (1) electron beam radiation or (2) gamma radiation under vacuum, wherein the radiation acts to increase the degree of cross-linking of the PVDF-HFP.
  • PVDF-HFP poly(vinylidene-co-hexafluoropropylene)
  • a further aspect of the present invention relates to a method that involves exposing a stent coated with paclitaxel and poly(styrene-b-isobutylene-b-styrene) (SIBS) to either (1) electron beam radiation or (2) gamma radiation in the presence of oxygen (O 2 ), wherein the radiation acts to decrease the degree of cross-linking of the SIBS.
  • SIBS poly(styrene-b-isobutylene-b-styrene)
  • Another aspect of the present invention relates to a method that involves exposing a stent coated with everolimus and PVDF-HFP to either (1) electron beam radiation or (2) gamma radiation, in the presence of oxygen, then exposing the stent to either (1) electron beam radiation or (2) gamma radiation, under vacuum.
  • This method provides a means for controlling the everolimus release rate and improving the mechanical properties of the coating.
  • a further aspect of the present invention relates to a method that involves coating a stent with a drug and polymer, wherein during the coating process the stent is exposed to ionizing radiation. This method provides a means for controlling the drug release rate and improving the mechanical properties of the coating.
  • the present invention provides methods for altering the molecular weight distribution (MWD) of fluoropolymers after drug-eluting stent (DES) coating processes have been completed, or in one situation, during the coating process. These methods act to tailor desired drug release rates as well as stent mechanical properties, and also act to promote favorable biological outcomes such as pro-healing in DES applications.
  • MFD molecular weight distribution
  • the present invention takes advantage of the above physical phenomena to design improved stent coatings using fluoropolymers, poly(styrene-b-isobutylene-b-styrene) (SIBS), and styrene-butadiene-styrene (SBS) polymers in conjunction with everolimus, paclitaxel and sirolimus as specific drugs, several embodiments of which are presented below.
  • SIBS poly(styrene-b-isobutylene-b-styrene)
  • SBS styrene-butadiene-styrene
  • PVDF-HFP poly(vinylidene-co-hexafluoropropylene)
  • everolimus-coated stent will be e-beam sterilized in a vacuum. This will enhance the degree of cross-linking of the PVDF-HFP polymer and improve its mechanical properties upon deployment in vivo.
  • a SIBS+paclitaxel-coated stent will be e-beam sterilized in the presence of O 2 at 0° C. This will reduce the G(X) for the system, i.e., decrease the degree of cross-linking of the SIBS.
  • a PVDF-HFP+everolimus-coated stent will first be e-beam sterilized in O 2 , then in a vacuum.
  • the resultant polymer will have different structural properties than PVDF-HFP, thereby altering the drug release rate and improving the mechanical properties of the coating.
  • gamma irradiation will be used in place of e-beam radiation for each of the first three embodiments of the present invention.
  • the radiation can be applied during the coating process. This will be achieved by sequential coating and exposure to ionizing radiation. Employing this strategy will enable more changes in the bulk of the polymer coating; however, the final objectives achieved will be similar to the post-coating embodiments set forth above.
  • ionizing radiation i.e., e-beam or gamma radiation
  • the present invention relates to a method that involves exposing a stent coated with a drug and polymer to ionizing radiation, wherein the radiation acts to either increase or decrease the degree of cross-linking of the polymer. This method provides a means for controlling the drug release rate and improving the mechanical properties of a coating.
  • Another aspect of the present invention relates to a method for exposing a stent coated with everolimus and PVDF-HFP to either (1) electron beam radiation or (2) gamma radiation under vacuum, wherein the radiation acts to increase the degree of cross-linking of the PVDF-HFP.
  • This method provides a means for controlling the everolimus release rate and improving the mechanical properties of the coating.
  • a further aspect of the present invention relates to a method that involves exposing a stent coated with paclitaxel and SIBS to either (1) electron beam radiation or (2) gamma radiation in the presence of oxygen (O 2 ), wherein the radiation acts to decrease the degree of cross-linking of the SIBS.
  • This method provides a means for controlling the paclitaxel release rate and improving the mechanical properties of the coating.
  • Another aspect of the present invention relates to a method that involves exposing a stent coated with everolimus and PVDF-HFP to either (1) electron beam radiation or (2) gamma radiation, in the presence of oxygen, then exposing the stem to either (1) electron beam radiation or (2) gamma radiation, under vacuum. This method provides a means for controlling the everolimus release rate and improving the mechanical properties of the coating.
  • a further aspect of the present invention relates to a method that involves coating a stent with a drug and polymer, wherein during the coating process the stent is exposed to ionizing radiation. This method provides a means for controlling the drug release rate and improving the mechanical properties of the coating.
  • a stent coated with a drug and polymer will be exposed to ionizing radiation to provide a means for controlling the drug release rate and improving the mechanical properties of a stent coating, as well as promote favorable biological outcomes such as pro-healing in DES applications.
  • a stent is a medical substrate that can be implanted in a human or veterinary patient.
  • stents include self-expandable stents and balloon-expandable stents.
  • the underlying structure of the stent can be of virtually any design.
  • the stent can be made of a metallic material or an alloy.
  • Suitable methods for coating a stent with a drug and polymer are known to those skilled in the art.
  • Suitable drugs are known to those skilled in the art, but preferably include everolimus, paclitaxel and sirolimus.
  • Suitable polymers are known to those skilled in the art, but preferably include fluoropolymers, PVDF-HFP, SIBS and SBS.
  • suitable sources of ionizing radiation include electron beam radiation, gamma radiation and Bremsstrahlung X-ray radiation.
  • the present invention provides several means for controlling the drug release rate and improving the mechanical properties of a stent coating.
  • Each method involves exposing a drug/polymer-coated stent to ionizing radiation, either in the presence of oxygen or under vacuum. This ionizing radiation exposure acts to either increase or decrease the degree of cross-linking of the polymer present in the coating, thereby providing a means for controlling the release rate and improving the mechanical properties of the stent coating.
  • Five mechanisms for achieving this, as encompassed by the present invention, are described above in accordance with the present invention.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Polymers & Plastics (AREA)
  • Organic Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Methods for controlling the release rate and improving the mechanical properties of a stent coating are disclosed.

Description

    CROSS REFERENCE TO RELATED APPLICATION
  • This application is a division of co-pending U.S. application Ser. No. 11/899,845, which was filed on Sep. 7, 2007, and which claims the benefit of and incorporates by reference U.S. patent application Ser. No. 60/843,068, which was filed on Sep. 8, 2006. U.S. application Ser. No. 11/899,845 is incorporated by reference herein in its entirety, including any drawings.
  • FIELD OF THE INVENTION
  • The present invention is directed methods for controlling the release rate and improving the mechanical properties of a stent coating.
  • BACKGROUND OF THE INVENTION
  • Improving the compositions from which medical articles, such as medical devices and coatings for medical devices, are produced is an ongoing goal of biomaterials research. An example of such a medical device is an implantable medical device.
  • A stent is an example of an implantable medical device that can benefit from improvements such as, for example, a coating that can be used as a vehicle for delivering pharmaceutically active agents in a predictable manner.
  • Stents play an important role in a variety of medical procedures such as, for example, percutaneous transluminal coronary angioplasty (PTCA). Stents act as a mechanical intervention to physically hold open and, if desired, expand a passageway within a subject. However, problems with the use of stents can include thrombosis and restenosis, which may develop several months after a particular procedure and create a need for additional angioplasty or a surgical by-pass operation.
  • To address these problems, stents are being developed to provide for the local delivery of agents, i.e., anti thrombotic and anti restenosis agents. One method of local delivery includes coating the surface of a medical article, e.g., a stent, with a polymeric carrier and attaching an agent to, or blending it with, the polymeric carrier. Agents can be used alone, and in combination. However, there is continual need for novel ways to control the release rate of an agent from a coating and for improving the mechanical properties of a stent coating.
  • The present invention provides such methods and is also directed to overcoming other deficiencies in the art.
  • SUMMARY OF THE INVENTION
  • The present invention relates to a method that involves exposing a stent coated with a drug and polymer to ionizing radiation, wherein the radiation acts to either increase or decrease the degree of cross-linking of the polymer. This method provides a means for controlling the drug release rate and improving the mechanical properties of a coating.
  • Another aspect of the present invention relates to a method for exposing a stent coated with everolimus and poly(vinylidene-co-hexafluoropropylene) (PVDF-HFP) to either (1) electron beam radiation or (2) gamma radiation under vacuum, wherein the radiation acts to increase the degree of cross-linking of the PVDF-HFP. This method provides a means for controlling the everolimus release rate and improving the mechanical properties of the coating.
  • A further aspect of the present invention relates to a method that involves exposing a stent coated with paclitaxel and poly(styrene-b-isobutylene-b-styrene) (SIBS) to either (1) electron beam radiation or (2) gamma radiation in the presence of oxygen (O2), wherein the radiation acts to decrease the degree of cross-linking of the SIBS. This method provides a means for controlling the paclitaxel release rate and improving the mechanical properties of the coating.
  • Another aspect of the present invention relates to a method that involves exposing a stent coated with everolimus and PVDF-HFP to either (1) electron beam radiation or (2) gamma radiation, in the presence of oxygen, then exposing the stent to either (1) electron beam radiation or (2) gamma radiation, under vacuum. This method provides a means for controlling the everolimus release rate and improving the mechanical properties of the coating.
  • A further aspect of the present invention relates to a method that involves coating a stent with a drug and polymer, wherein during the coating process the stent is exposed to ionizing radiation. This method provides a means for controlling the drug release rate and improving the mechanical properties of the coating.
  • The present invention provides methods for altering the molecular weight distribution (MWD) of fluoropolymers after drug-eluting stent (DES) coating processes have been completed, or in one situation, during the coating process. These methods act to tailor desired drug release rates as well as stent mechanical properties, and also act to promote favorable biological outcomes such as pro-healing in DES applications.
  • The present invention takes advantage of the following physical phenomena:
      • The MWD of polymers and their state of cross-linking can be altered upon exposure to high energy ionizing radiation, such as electron-beam (e-beam) radiation, gamma radiation and Bremsstrahlung X-ray radiation produced by an accelerator.
      • The penetration of X-rays can be as high as one order of magnitude more than the penetration of e-beam radiation.
      • The G-factor, i.e., the extent a polymer changes as a result of radiation sterilization, G(X), i.e., the extent of polymer cross-linking, G(S), i.e., the extent of polymer chain scission, and G(Gas), i.e., the extent of gaseous product of the polymer post-sterilization, depends on the type of polymer and the dose of ionizing radiation.
      • G(X)<G(S) in the presence of O2, in contrast to under vacuum.
      • At low ionizing radiation dosages, i.e., less than 20 Mrad, polyvinylidene fluoride (PVDF), poly(tetrafluoroethylene) (PTFE) and ultra high molecular weight polyethylene (UHMPE) increase in crystallinity while at high doses, i.e., around 2000 Mrad, both the degree of crystallinity and the Tm drops, e.g., the Tm drops by around 25° C. for poly(ethylene terephthalate) (PET).
      • The presence of an aromatic group, e.g., on polystyrene, has a protective effect on both G(S) and G(X).
  • The present invention takes advantage of the above physical phenomena to design improved stent coatings using fluoropolymers, poly(styrene-b-isobutylene-b-styrene) (SIBS), and styrene-butadiene-styrene (SBS) polymers in conjunction with everolimus, paclitaxel and sirolimus as specific drugs, several embodiments of which are presented below.
  • In a first embodiment, a poly(vinylidene-co-hexafluoropropylene) (PVDF-HFP)+everolimus-coated stent will be e-beam sterilized in a vacuum. This will enhance the degree of cross-linking of the PVDF-HFP polymer and improve its mechanical properties upon deployment in vivo.
  • In a second embodiment, a SIBS+paclitaxel-coated stent will be e-beam sterilized in the presence of O2 at 0° C. This will reduce the G(X) for the system, i.e., decrease the degree of cross-linking of the SIBS.
  • In a third embodiment, a PVDF-HFP+everolimus-coated stent will first be e-beam sterilized in O2, then in a vacuum. The resultant polymer will have different structural properties than PVDF-HFP, thereby altering the drug release rate and improving the mechanical properties of the coating.
  • In a fourth embodiment, gamma irradiation will be used in place of e-beam radiation for each of the first three embodiments of the present invention.
  • In a fifth embodiment, instead of applying ionizing radiation, i.e., e-beam or gamma radiation, to a DES after the coating process has been completed, the radiation can be applied during the coating process. This will be achieved by sequential coating and exposure to ionizing radiation. Employing this strategy will enable more changes in the bulk of the polymer coating; however, the final objectives achieved will be similar to the post-coating embodiments set forth above.
  • DETAILED DESCRIPTION
  • The present invention relates to a method that involves exposing a stent coated with a drug and polymer to ionizing radiation, wherein the radiation acts to either increase or decrease the degree of cross-linking of the polymer. This method provides a means for controlling the drug release rate and improving the mechanical properties of a coating.
  • Another aspect of the present invention relates to a method for exposing a stent coated with everolimus and PVDF-HFP to either (1) electron beam radiation or (2) gamma radiation under vacuum, wherein the radiation acts to increase the degree of cross-linking of the PVDF-HFP. This method provides a means for controlling the everolimus release rate and improving the mechanical properties of the coating.
  • A further aspect of the present invention relates to a method that involves exposing a stent coated with paclitaxel and SIBS to either (1) electron beam radiation or (2) gamma radiation in the presence of oxygen (O2), wherein the radiation acts to decrease the degree of cross-linking of the SIBS. This method provides a means for controlling the paclitaxel release rate and improving the mechanical properties of the coating. Another aspect of the present invention relates to a method that involves exposing a stent coated with everolimus and PVDF-HFP to either (1) electron beam radiation or (2) gamma radiation, in the presence of oxygen, then exposing the stem to either (1) electron beam radiation or (2) gamma radiation, under vacuum. This method provides a means for controlling the everolimus release rate and improving the mechanical properties of the coating.
  • A further aspect of the present invention relates to a method that involves coating a stent with a drug and polymer, wherein during the coating process the stent is exposed to ionizing radiation. This method provides a means for controlling the drug release rate and improving the mechanical properties of the coating.
  • According to the present invention, a stent coated with a drug and polymer will be exposed to ionizing radiation to provide a means for controlling the drug release rate and improving the mechanical properties of a stent coating, as well as promote favorable biological outcomes such as pro-healing in DES applications.
  • According to the present invention, a stent is a medical substrate that can be implanted in a human or veterinary patient. Examples of stents include self-expandable stents and balloon-expandable stents. The underlying structure of the stent can be of virtually any design. The stent can be made of a metallic material or an alloy.
  • Suitable methods for coating a stent with a drug and polymer are known to those skilled in the art. Suitable drugs are known to those skilled in the art, but preferably include everolimus, paclitaxel and sirolimus. Suitable polymers are known to those skilled in the art, but preferably include fluoropolymers, PVDF-HFP, SIBS and SBS.
  • According to the present invention, suitable sources of ionizing radiation include electron beam radiation, gamma radiation and Bremsstrahlung X-ray radiation.
  • The present invention provides several means for controlling the drug release rate and improving the mechanical properties of a stent coating. Each method involves exposing a drug/polymer-coated stent to ionizing radiation, either in the presence of oxygen or under vacuum. This ionizing radiation exposure acts to either increase or decrease the degree of cross-linking of the polymer present in the coating, thereby providing a means for controlling the release rate and improving the mechanical properties of the stent coating. Five mechanisms for achieving this, as encompassed by the present invention, are described above in accordance with the present invention.
  • While particular embodiments of the present invention have been shown and described, it will be obvious to those skilled in the art that changes and modifications can be made without departing from this invention in its broader aspects. Therefore, the claims are to encompass within their scope all such changes and modifications as fall within the true sprit and scope of this invention.

Claims (3)

1. A method comprising:
exposing a stent coated with paclitaxel and SIBS to either (1) electron beam radiation or (2) gamma radiation in the presence of oxygen, wherein the radiation acts to decrease the degree of cross-linking of the SIBS, thereby providing a means for controlling the paclitaxel release rate and improving the mechanical properties of the coating.
2. The method of claim 1, wherein the exposure is to electron beam radiation.
3. The method of claim 1, wherein the exposure is to gamma radiation.
US13/191,336 2006-09-08 2011-07-26 Methods For Controlling The Release Rate And Improving The Mechanical Properties Of A Stent Coating Abandoned US20110281022A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US13/191,336 US20110281022A1 (en) 2006-09-08 2011-07-26 Methods For Controlling The Release Rate And Improving The Mechanical Properties Of A Stent Coating

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US84306806P 2006-09-08 2006-09-08
US11/899,845 US8007857B1 (en) 2006-09-08 2007-09-07 Methods for controlling the release rate and improving the mechanical properties of a stent coating
US13/191,336 US20110281022A1 (en) 2006-09-08 2011-07-26 Methods For Controlling The Release Rate And Improving The Mechanical Properties Of A Stent Coating

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
US11/899,845 Division US8007857B1 (en) 2006-09-08 2007-09-07 Methods for controlling the release rate and improving the mechanical properties of a stent coating

Publications (1)

Publication Number Publication Date
US20110281022A1 true US20110281022A1 (en) 2011-11-17

Family

ID=44486245

Family Applications (2)

Application Number Title Priority Date Filing Date
US11/899,845 Expired - Fee Related US8007857B1 (en) 2006-09-08 2007-09-07 Methods for controlling the release rate and improving the mechanical properties of a stent coating
US13/191,336 Abandoned US20110281022A1 (en) 2006-09-08 2011-07-26 Methods For Controlling The Release Rate And Improving The Mechanical Properties Of A Stent Coating

Family Applications Before (1)

Application Number Title Priority Date Filing Date
US11/899,845 Expired - Fee Related US8007857B1 (en) 2006-09-08 2007-09-07 Methods for controlling the release rate and improving the mechanical properties of a stent coating

Country Status (1)

Country Link
US (2) US8007857B1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014165829A3 (en) * 2013-04-05 2014-12-31 Igdrasol Nanoparticle formulations

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2519467B1 (en) * 2009-12-28 2020-09-09 Colorado State University Research Foundation Modular biocompatible materials for medical devices and uses thereof
WO2018191415A1 (en) 2017-04-11 2018-10-18 Colorado State University Research Foundation Functionalization of metal-organic frameworks

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4652763A (en) * 1985-03-29 1987-03-24 Energy Sciences, Inc. Electron-beam irradiation sterilization process
US20050025801A1 (en) * 2003-07-31 2005-02-03 Richard Robert E. Implantable or insertable medical devices containing radiation-treated polymer for improved delivery of therapeutic agent
US20050271646A1 (en) * 1995-01-16 2005-12-08 Baxter International Inc. Fibrin material and method for producing and using the same

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5289831A (en) 1989-03-09 1994-03-01 Vance Products Incorporated Surface-treated stent, catheter, cannula, and the like
US5137541A (en) 1991-03-18 1992-08-11 Foster John D Polishing compounds and methods
US5492763A (en) 1992-06-08 1996-02-20 Spire Corporation Infection resistant medical devices and process
US5837313A (en) 1995-04-19 1998-11-17 Schneider (Usa) Inc Drug release stent coating process
US6676595B1 (en) 1998-08-24 2004-01-13 Varian Medical Systems Technologies, Inc. Radioactive medical implant and method of manufacturing
GB9820214D0 (en) * 1998-09-17 1998-11-11 Raychem Ltd Bonding polymer interface
US6120847A (en) 1999-01-08 2000-09-19 Scimed Life Systems, Inc. Surface treatment method for stent coating
US6368658B1 (en) 1999-04-19 2002-04-09 Scimed Life Systems, Inc. Coating medical devices using air suspension
US6713119B2 (en) 1999-09-03 2004-03-30 Advanced Cardiovascular Systems, Inc. Biocompatible coating for a prosthesis and a method of forming the same
US8303651B1 (en) 2001-09-07 2012-11-06 Advanced Cardiovascular Systems, Inc. Polymeric coating for reducing the rate of release of a therapeutic substance from a stent
JP2003166764A (en) 2001-09-20 2003-06-13 Denso Corp Refrigerating cycle device
US20030082905A1 (en) 2001-10-31 2003-05-01 Jen-Ku Hung Method for forming a uniform damascene profile
US6764709B2 (en) 2001-11-08 2004-07-20 Scimed Life Systems, Inc. Method for making and measuring a coating on the surface of a medical device using an ultraviolet laser
US7431959B1 (en) 2003-07-31 2008-10-07 Advanced Cardiovascular Systems Inc. Method and system for irradiation of a drug eluting implantable medical device
US7807722B2 (en) * 2003-11-26 2010-10-05 Advanced Cardiovascular Systems, Inc. Biobeneficial coating compositions and methods of making and using thereof
US20050171596A1 (en) * 2004-02-03 2005-08-04 Furst Joseph G. Stents with amphiphilic copolymer coatings
US7547405B2 (en) * 2004-10-07 2009-06-16 Biomet Manufacturing Corp. Solid state deformation processing of crosslinked high molecular weight polymeric materials

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4652763A (en) * 1985-03-29 1987-03-24 Energy Sciences, Inc. Electron-beam irradiation sterilization process
US20050271646A1 (en) * 1995-01-16 2005-12-08 Baxter International Inc. Fibrin material and method for producing and using the same
US20050025801A1 (en) * 2003-07-31 2005-02-03 Richard Robert E. Implantable or insertable medical devices containing radiation-treated polymer for improved delivery of therapeutic agent

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014165829A3 (en) * 2013-04-05 2014-12-31 Igdrasol Nanoparticle formulations

Also Published As

Publication number Publication date
US8007857B1 (en) 2011-08-30

Similar Documents

Publication Publication Date Title
Cheruthazhekatt et al. Gas plasmas and plasma modified materials in medicine
US9421223B2 (en) Nitric oxide generating medical devices
EP2442841B1 (en) Implantable medical devices and coatings therefor comprising block copolymers of poly (ethylene glycol) and a poly (lactide-glycolide)
US6335029B1 (en) Polymeric coatings for controlled delivery of active agents
US20070198080A1 (en) Coatings including an antioxidant
US8246904B2 (en) Radiation sterilization of medical devices
US20140335143A1 (en) Polymer Blends For Drug Delivery Stent Matrix With Improved Thermal Stability
CN103619568B (en) Regulate after the electron beam of polymer medical devices
US8524166B2 (en) Stent and delivery system with reduced chemical degradation including a Chitooligosaccharide
US20160158420A1 (en) Coatings formed from stimulus-sensitive material
WO2005110508A2 (en) Modulating properties of coatings on implantable devices
EP2222351A2 (en) An implantable device having a slow dissolving polymer
Munoz-Munoz et al. Temperature-and pH-sensitive interpenetrating polymer networks grafted on PP: cross-linking irradiation dose as a critical variable for the performance as vancomycin-eluting systems
US9669137B2 (en) Modified polylactide polymers
US8007857B1 (en) Methods for controlling the release rate and improving the mechanical properties of a stent coating
Muñoz-Muñoz et al. Novel interpenetrating smart polymer networks grafted onto polypropylene by gamma radiation for loading and delivery of vancomycin
EP2707045A1 (en) Methods of stabilizing molecular weight of polymer stents after sterilization
EP2605807A2 (en) Post electron beam stabilization of polymeric medical devices
CN105025946B (en) Implantable medical device and manufacture method comprising big ring triolefin lactone medicine and minimum antioxidative stabilizer
Ramakrishna et al. Basic concepts and clinical outcomes of drug-eluting balloons for treatment of coronary artery disease: an overview
US20130032967A1 (en) Cold ethylene oxide sterilization of a biodegradable polymeric stent
EP3027236A1 (en) mTOR INHIBITOR ELUTING MEDICAL DEVICE
Han et al. Recent alternative approaches of vascular drug-eluting stents
Yang et al. An overview of patented technology for fully-degradable polylactic acid stents
KUTRYK CARDIOLOGY Rounds

Legal Events

Date Code Title Description
STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION