WO1994021309A1 - Polyurethane-coated intravascular prostheses (stents) for the treatment of blood vessel stenosis - Google Patents

Polyurethane-coated intravascular prostheses (stents) for the treatment of blood vessel stenosis Download PDF

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Publication number
WO1994021309A1
WO1994021309A1 PCT/BE1994/000024 BE9400024W WO9421309A1 WO 1994021309 A1 WO1994021309 A1 WO 1994021309A1 BE 9400024 W BE9400024 W BE 9400024W WO 9421309 A1 WO9421309 A1 WO 9421309A1
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WO
WIPO (PCT)
Prior art keywords
blood vessel
prostheses
treatment
polyurethanes
coated
Prior art date
Application number
PCT/BE1994/000024
Other languages
French (fr)
Original Assignee
N.V. D.S.B.
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 N.V. D.S.B. filed Critical N.V. D.S.B.
Priority to AU61780/94A priority Critical patent/AU6178094A/en
Publication of WO1994021309A1 publication Critical patent/WO1994021309A1/en

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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
    • 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
    • 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
    • A61L31/02—Inorganic materials
    • A61L31/022—Metals or alloys
    • 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
    • A61L31/08—Materials for coatings
    • A61L31/10—Macromolecular materials
    • 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

Definitions

  • Treatment of blood vessel stenoses by means of a balloon catheter is a popular method. Last year, more than
  • One of these new methods consist of placing a metal
  • intravascular prothesis at the level of the vessel stenosis.
  • This method is very efficient for treating vessel tears which can occur during balloon dilatation.
  • the problems with this metallic stents however are that they have proven to be thrombogenic and can cause an acute thrombotic occlusion of the treated blood vessel.
  • Amphiphilic polyurethanes were synthesized starting from amphiphilic polyester diols on the basis of ethylene oxide and proylene oxide. By reaction with a diisocyanate and a chain lengthener ( butanediol), a thermoplastic polyurethane is finally obtained. By the appropriate choice of a) the polyesterdiol, especially the proportion of
  • polyurethane-coated devices turned out to be very critical. We used certain amounts of gamma radiation which resulted in the formation of further crossbridging of the polymer leading to a more stable and more elastic polymer which is critical during the stent deployment. The resulting polymers turned out to be very stable when inplanted in human or animal tissues or blood vessels. Furthermore they did not provoke any inflammatory reaction.
  • stents heparin, hirudin, streptokinase, urokinase, tpa and other anticoagulants
  • inflammatory reaction caused by the stent corticosteroids, antimitotics, angiopeptin and other antiinflammatoy drugs.

Abstract

A new method to treat blood vessel stenosis using endovascular prostheses which are coated with amphiphilic polyurethanes to which medicines can be coupled. By coating endovascular prosthesis with amphiphilic polyurethanes, we have succeeded in significantly improving the bio- and bloodcompatibility of endovascular prostheses. These amphiphilic polyurethanes have the property, when implanted in human or animal tissue and blood vessels, of remaining stable and seeming not to provoke an inflammatory reaction. Furthermore it is possible to incorporate medicines in these polymers which, after implantation of the polymers, are slowly released at the location of the place of implantation. This system can further reduce the thrombogenicity of the prostheses coated with the polyurethanes and inhibit the rejection against these prostheses.

Description

POLYURETHANE-COATED INTRAVASCULAR PROTHESES (STENTS) FOR THE TREATMENT OF BLOOD VESSEL STENOSES. A new method to treat blood vessel stenoses by means of endovascular protheses which are coated with amphiphylic polyurethanes to which medicines can be coupled.
DESCRIPTION
Treatment of blood vessel stenoses by means of a balloon catheter is a popular method. Last year, more than
6,000 patients with coronary heart disease were treated by this method in our country. The problem with this method is on the one hand the danger that a tear occurs during the blowing up of the balloon whereby the blood vessel c an close and thus cause an acute myocardial infarction, on the other hand it is well documented that this treatment method is accompanied by a frequent restenosis of the treated blood vessel within 6 months of the treatment. To solve this problems, medicines were tested in order to prevent the restenosis and furthermore new devices were developed.
One of these new methods consist of placing a metal
intravascular prothesis (stent) at the level of the vessel stenosis. This method is very efficient for treating vessel tears which can occur during balloon dilatation. The problems with this metallic stents however are that they have proven to be thrombogenic and can cause an acute thrombotic occlusion of the treated blood vessel. On the other hand, it appeared that through the inplantation of a metal stent in a blood vessel, the body can react with an inflammatory
reaction whereby restenosis within the stent can occur.
By covering these endovascular protheses with amphiphylic polyurethanes, we succeeded in significantly limiting both the problem of trombogenecity as well as the problem of reactive hyperproliferatlve response.
Amphiphilic polyurethanes were synthesized starting from amphiphilic polyester diols on the basis of ethylene oxide and proylene oxide. By reaction with a diisocyanate and a chain lengthener ( butanediol), a thermoplastic polyurethane is finally obtained. By the appropriate choice of a) the polyesterdiol, especially the proportion of
ethy leneoxide/propyleneoxide, and b) the molecular weight of the diol, the bio- and blood compatibility can be optimized. Furthermore the kind of sterilisation of
polyurethane-coated devices turned out to be very critical. We used certain amounts of gamma radiation which resulted in the formation of further crossbridging of the polymer leading to a more stable and more elastic polymer which is critical during the stent deployment. The resulting polymers turned out to be very stable when inplanted in human or animal tissues or blood vessels. Furthermore they did not provoke any inflammatory reaction.
Furthermore we were able to load these polyurethanes with medicines, which were released slowly at the polymer
implantation side. These medicines are used to further- decrease the thrombogenecity of the stents (heparin, hirudin, streptokinase, urokinase, tpa and other anticoagulants) and to inhibit the inflammatory reaction caused by the stent (corticosteroids, antimitotics, angiopeptin and other antiinflammatoy drugs.) Using methylprednisolone loaded polyurethane coated stents we were able to block totally the stent restenosis in a pig coronary model.
APPLICATION POSSIBILITES OF THE SYSTEM
1. Treatment of blood vessel stenosis in humans and animals.
2. Treatment of complications occurring during other
treatment methods of blood vessel stenosis.
3. Treatment of complications occurring during diagnostic procedures.
4. Coating of prosteses, wires, and catheters introduced for medical purposes.

Claims

By coating endovascular protheses with amphiphylic
polyurethanes, we have developed an efficient method to treat blood vessel stenosis. This method proved to considerably limit the thrombogenicity as well as the rejection against endovascular protheses so that this method signifies an important step forward in the treatment of blood vessel stenosis.
PCT/BE1994/000024 1993-03-24 1994-03-24 Polyurethane-coated intravascular prostheses (stents) for the treatment of blood vessel stenosis WO1994021309A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU61780/94A AU6178094A (en) 1993-03-24 1994-03-24 Polyurethane-coated intravascular prostheses (stents) for the treatment of blood vessel stenosis

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
BE9300285 1993-03-24
BE9300285A BE1006819A7 (en) 1993-03-24 1993-03-24 Polyurethane coated prostheses (stents) FOR THE TREATMENT OF VESSEL CHOKES.

Publications (1)

Publication Number Publication Date
WO1994021309A1 true WO1994021309A1 (en) 1994-09-29

Family

ID=3886925

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/BE1994/000024 WO1994021309A1 (en) 1993-03-24 1994-03-24 Polyurethane-coated intravascular prostheses (stents) for the treatment of blood vessel stenosis

Country Status (3)

Country Link
AU (1) AU6178094A (en)
BE (1) BE1006819A7 (en)
WO (1) WO1994021309A1 (en)

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997010011A1 (en) * 1995-09-11 1997-03-20 Schneider (Usa) Inc. Drug release stent coating process
US5980972A (en) * 1996-12-20 1999-11-09 Schneider (Usa) Inc Method of applying drug-release coatings
US6099562A (en) * 1996-06-13 2000-08-08 Schneider (Usa) Inc. Drug coating with topcoat
US6120536A (en) * 1995-04-19 2000-09-19 Schneider (Usa) Inc. Medical devices with long term non-thrombogenic coatings
WO2002055121A1 (en) * 2001-01-11 2002-07-18 Biocompatibles Uk Limited Drug delivery from stents
US6776796B2 (en) 2000-05-12 2004-08-17 Cordis Corportation Antiinflammatory drug and delivery device
WO2006047378A2 (en) * 2004-10-21 2006-05-04 Medtronic Vascular, Inc. Biocompatible and hemocompatible amphiphilic coatings for drug deliver
US8182527B2 (en) 2001-05-07 2012-05-22 Cordis Corporation Heparin barrier coating for controlled drug release
US8236048B2 (en) 2000-05-12 2012-08-07 Cordis Corporation Drug/drug delivery systems for the prevention and treatment of vascular disease
US8303609B2 (en) 2000-09-29 2012-11-06 Cordis Corporation Coated medical devices
DE102014201889A1 (en) 2014-02-03 2015-08-20 Aesculap Ag Medical product for use in the treatment of hernias
US9308355B2 (en) 2012-06-01 2016-04-12 Surmodies, Inc. Apparatus and methods for coating medical devices
US9827401B2 (en) 2012-06-01 2017-11-28 Surmodics, Inc. Apparatus and methods for coating medical devices
US11628466B2 (en) 2018-11-29 2023-04-18 Surmodics, Inc. Apparatus and methods for coating medical devices
US11819590B2 (en) 2019-05-13 2023-11-21 Surmodics, Inc. Apparatus and methods for coating medical devices

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4371686A (en) * 1980-09-12 1983-02-01 Agency Of Industrial Science & Technology Ministry Of International Trade & Industry Antithrombogenic, highly elastic polyurethane compound
WO1987004935A1 (en) * 1986-02-24 1987-08-27 Fischell Robert An intravascular stent and percutaneous insertion system
WO1992015286A1 (en) * 1991-02-27 1992-09-17 Nova Pharmaceutical Corporation Anti-infective and anti-inflammatory releasing systems for medical devices
EP0518704A1 (en) * 1991-06-14 1992-12-16 Scimed Life Systems, Inc. Temporary stents and method of manufacture
EP0566245A1 (en) * 1992-03-19 1993-10-20 Medtronic, Inc. Intraluminal stent

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4371686A (en) * 1980-09-12 1983-02-01 Agency Of Industrial Science & Technology Ministry Of International Trade & Industry Antithrombogenic, highly elastic polyurethane compound
WO1987004935A1 (en) * 1986-02-24 1987-08-27 Fischell Robert An intravascular stent and percutaneous insertion system
WO1992015286A1 (en) * 1991-02-27 1992-09-17 Nova Pharmaceutical Corporation Anti-infective and anti-inflammatory releasing systems for medical devices
EP0518704A1 (en) * 1991-06-14 1992-12-16 Scimed Life Systems, Inc. Temporary stents and method of manufacture
EP0566245A1 (en) * 1992-03-19 1993-10-20 Medtronic, Inc. Intraluminal stent

Cited By (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6620194B2 (en) 1995-04-19 2003-09-16 Boston Scientific Scimed, Inc. Drug coating with topcoat
US5837313A (en) * 1995-04-19 1998-11-17 Schneider (Usa) Inc Drug release stent coating process
US6120536A (en) * 1995-04-19 2000-09-19 Schneider (Usa) Inc. Medical devices with long term non-thrombogenic coatings
US6358556B1 (en) 1995-04-19 2002-03-19 Boston Scientific Corporation Drug release stent coating
AU703805B2 (en) * 1995-09-11 1999-04-01 Schneider (Usa) Inc. Drug release stent coating process
EP1647287A3 (en) * 1995-09-11 2006-04-26 Boston Scientific Scimed, Inc. Drug release stent coating process
EP1647287A2 (en) * 1995-09-11 2006-04-19 Boston Scientific Scimed, Inc. Drug release stent coating process
EP1559439A1 (en) * 1995-09-11 2005-08-03 Boston Scientific Scimed, Inc. Drug release stent coating process
WO1997010011A1 (en) * 1995-09-11 1997-03-20 Schneider (Usa) Inc. Drug release stent coating process
US6284305B1 (en) 1996-06-13 2001-09-04 Schneider (Usa) Inc. Drug coating with topcoat
US6099562A (en) * 1996-06-13 2000-08-08 Schneider (Usa) Inc. Drug coating with topcoat
US5980972A (en) * 1996-12-20 1999-11-09 Schneider (Usa) Inc Method of applying drug-release coatings
US6776796B2 (en) 2000-05-12 2004-08-17 Cordis Corportation Antiinflammatory drug and delivery device
US8236048B2 (en) 2000-05-12 2012-08-07 Cordis Corporation Drug/drug delivery systems for the prevention and treatment of vascular disease
US8303609B2 (en) 2000-09-29 2012-11-06 Cordis Corporation Coated medical devices
US8465758B2 (en) 2001-01-11 2013-06-18 Abbott Laboratories Drug delivery from stents
US7713538B2 (en) 2001-01-11 2010-05-11 Abbott Laboratories Drug delivery from stents
US8057814B2 (en) 2001-01-11 2011-11-15 Abbott Laboratories Drug delivery from stents
WO2002055121A1 (en) * 2001-01-11 2002-07-18 Biocompatibles Uk Limited Drug delivery from stents
US8182527B2 (en) 2001-05-07 2012-05-22 Cordis Corporation Heparin barrier coating for controlled drug release
WO2006047378A3 (en) * 2004-10-21 2007-02-15 Medtronic Vascular Inc Biocompatible and hemocompatible amphiphilic coatings for drug deliver
WO2006047378A2 (en) * 2004-10-21 2006-05-04 Medtronic Vascular, Inc. Biocompatible and hemocompatible amphiphilic coatings for drug deliver
US9827401B2 (en) 2012-06-01 2017-11-28 Surmodics, Inc. Apparatus and methods for coating medical devices
US9308355B2 (en) 2012-06-01 2016-04-12 Surmodies, Inc. Apparatus and methods for coating medical devices
US9623215B2 (en) 2012-06-01 2017-04-18 Surmodics, Inc. Apparatus and methods for coating medical devices
US10099041B2 (en) 2012-06-01 2018-10-16 Surmodics, Inc. Apparatus and methods for coating medical devices
US10507309B2 (en) 2012-06-01 2019-12-17 Surmodics, Inc. Apparatus and methods for coating medical devices
DE102014201889A1 (en) 2014-02-03 2015-08-20 Aesculap Ag Medical product for use in the treatment of hernias
US11628466B2 (en) 2018-11-29 2023-04-18 Surmodics, Inc. Apparatus and methods for coating medical devices
US11819590B2 (en) 2019-05-13 2023-11-21 Surmodics, Inc. Apparatus and methods for coating medical devices

Also Published As

Publication number Publication date
AU6178094A (en) 1994-10-11
BE1006819A7 (en) 1994-12-13

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