WO2002043787A1 - Stent - Google Patents

Stent Download PDF

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Publication number
WO2002043787A1
WO2002043787A1 PCT/EP2000/012078 EP0012078W WO0243787A1 WO 2002043787 A1 WO2002043787 A1 WO 2002043787A1 EP 0012078 W EP0012078 W EP 0012078W WO 0243787 A1 WO0243787 A1 WO 0243787A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
weight
niobium
alloy
stainless steel
Prior art date
Application number
PCT/EP2000/012078
Other languages
French (fr)
Inventor
Marcel Antonius Elisabeth Verbeek
Original Assignee
Fortimedix B.V.
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 Fortimedix B.V. filed Critical Fortimedix B.V.
Priority to PCT/EP2000/012078 priority Critical patent/WO2002043787A1/en
Priority to EP00981326A priority patent/EP1337286A1/en
Priority to AU2001218611A priority patent/AU2001218611A1/en
Publication of WO2002043787A1 publication Critical patent/WO2002043787A1/en

Links

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
    • A61L31/02—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
    • A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/18—Materials at least partially X-ray or laser opaque
    • 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

Definitions

  • the invention relates to a stent, especially a stent for reinforcing a blood vessel wall.
  • Stents are generally known, and by way of example reference is made to US-A-5628787, US-A-5630840 and EP-A-0873734.
  • Gold-coated stainless steel stent are difficult to make and are relatively expensive. Moreover there might be a problem that the gold layer is not sufficiently adhered to the supporting base material so that locally the coating cracks or flakes off the stent during expansion. Such local removal of the gold coating can result into adverse corrosion effects and free floating of gold particles in the visculature. Moreover the use of two different metals or metal alloys contacting each other may imply galvanic reactions of which long term clinical effects are unknown, but of which it is suspected that they negatively affect restenosis rates.
  • tantalium In another stent use is made of tantalium as constructive material for the stent. This has resulted in a reliable stent, but tantalium has the disadvantage that it is too visible in radiographic imaging, to such an extend that it obstructs the imaging of the result of the implantation of such stent. It is therefore an object of the invention to provide a stent avoiding the above mentioned problems.
  • the stent is made of an alloy comprising at least 90 % by weight of niobium.
  • niobium is a metal offering the combination of required characteristics especially with respect to the mechanical and chemical properties and in view of the radiographic imaging.
  • the alloy comprise at least 95 % by weight niobium and more preferably at least 98 %.
  • Niobium can be combined with a number of other metals in order to obtain the required characteristics.
  • the niobium alloy contains further one or more elements selected from the group of Zr, Ti, V, Hf, W, Ta and Mo.
  • the alloy consists of 98,5 - 99,5 % by weight of niobium and 0,1 - 1 ,5 % by weight of zirconium.

Abstract

Stent especially stent for opening and supporting obstructions in a blood vessel, which stent is made of an alloy comprising at least 90 % by weight of niobium. Preferably the alloy contains other elements selected from the group of Zr, Ti, V, Hf, W, Ta and Mo. The most preferred alloy consists of 98,5 - 99,5 % by weight of niobium and 0,1 - 1,5 % by weight of zirconium.

Description

Stent
The invention relates to a stent, especially a stent for reinforcing a blood vessel wall.
Stents are generally known, and by way of example reference is made to US-A-5628787, US-A-5630840 and EP-A-0873734.
Up till now a number of metals or metal alloys have been used and/or proposed as basic material for the stent.
In a first type of stent stainless steel has been used especially stainless steel 316 (L, LVM).
One of the problems with this alloy is that it contains nickel, which can lead to unwanted reactions with patients sensitive to this metal, because of the so-called nickel-allergy. Otherwise a stent must be clearly visible in a radiography and clearly discernible from its surrounding while being implanted.
This is especially important because the stent must be positioned in the optimal way in order to have the optimal result. Stainless steel does not give a good reflection to X-ray radiation implying that its visibility while being implanted is low and far from optimal.
In view of these problems with stainless steel it has been proposed to use stainless steel coated with other metals, especially with gold. This has resulted in a better visibility of the stent during implantation, and from that point of view such a stent will have good results.
Gold-coated stainless steel stent are difficult to make and are relatively expensive. Moreover there might be a problem that the gold layer is not sufficiently adhered to the supporting base material so that locally the coating cracks or flakes off the stent during expansion. Such local removal of the gold coating can result into adverse corrosion effects and free floating of gold particles in the visculature. Moreover the use of two different metals or metal alloys contacting each other may imply galvanic reactions of which long term clinical effects are unknown, but of which it is suspected that they negatively affect restenosis rates.
In another stent use is made of tantalium as constructive material for the stent. This has resulted in a reliable stent, but tantalium has the disadvantage that it is too visible in radiographic imaging, to such an extend that it obstructs the imaging of the result of the implantation of such stent. It is therefore an object of the invention to provide a stent avoiding the above mentioned problems.
This object has been obtained in that the stent is made of an alloy comprising at least 90 % by weight of niobium.
It has been found that niobium is a metal offering the combination of required characteristics especially with respect to the mechanical and chemical properties and in view of the radiographic imaging.
In a preferred embodiment of the invention the alloy comprise at least 95 % by weight niobium and more preferably at least 98 %.
Niobium can be combined with a number of other metals in order to obtain the required characteristics.
According to the invention it is preferred that the niobium alloy contains further one or more elements selected from the group of Zr, Ti, V, Hf, W, Ta and Mo.
Most of these elements, or combinations thereof, improve the mechanical characteristics of the alloy without negatively influencing the biocompatibility with blood or blood vessel systems nor the visibility in radiography.
In the most preferred embodiment of the invention the alloy consists of 98,5 - 99,5 % by weight of niobium and 0,1 - 1 ,5 % by weight of zirconium.

Claims

Claims
1. Stent especially stent for opening and supporting obstructions in a blood vessel, characterized in that it is made of an alloy comprising at least 90 % by weight of niobium
2. Stent according to claim 1 , characterized in that it comprises at least 95 % by weight of niobium
3. Stent according to claim 2, characterized in that it comprises at least 98 % by weight of niobium
4. Stent according to anyone of the claims 1-3, characterized in that the alloy further comprises one or more elements selected from the group of Zr, Ti, V, Hf, W, Ta and Mo.
5. Stent according to claim 4, characterized in that the alloy consists of 98,5 - 99,5 % by weight of niobium and 0,5 - 1 ,5 % by weight of zirconium
PCT/EP2000/012078 2000-11-28 2000-11-28 Stent WO2002043787A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
PCT/EP2000/012078 WO2002043787A1 (en) 2000-11-28 2000-11-28 Stent
EP00981326A EP1337286A1 (en) 2000-11-28 2000-11-28 Stent
AU2001218611A AU2001218611A1 (en) 2000-11-28 2000-11-28 Stent

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2000/012078 WO2002043787A1 (en) 2000-11-28 2000-11-28 Stent

Publications (1)

Publication Number Publication Date
WO2002043787A1 true WO2002043787A1 (en) 2002-06-06

Family

ID=8164182

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2000/012078 WO2002043787A1 (en) 2000-11-28 2000-11-28 Stent

Country Status (3)

Country Link
EP (1) EP1337286A1 (en)
AU (1) AU2001218611A1 (en)
WO (1) WO2002043787A1 (en)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004019822A1 (en) * 2002-08-31 2004-03-11 Boston Scientific Limited Niobium stent
EP1403390A1 (en) * 2002-09-27 2004-03-31 W.C. Heraeus GmbH & Co. KG A Nb-Zr-Ta Alloy for use in the manufacture of Stents
WO2005044327A1 (en) * 2003-11-11 2005-05-19 W.C. Heraeus Gmbh Niobium-zirconium alloy for medical devices or their parts
WO2006076447A2 (en) * 2005-01-13 2006-07-20 Boston Scientific Limited Medical devices and comprising alloys
WO2008100852A3 (en) * 2007-02-13 2009-12-03 Abbott Cardiovascular Systems Inc. Mri compatible, radiopaque alloys for use in medical devices
US8349249B2 (en) 2003-02-10 2013-01-08 Heraeus Precious Metals Gmbh & Co. Kg Metal alloy for medical devices and implants

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5628787A (en) 1993-01-19 1997-05-13 Schneider (Usa) Inc. Clad composite stent
US5630840A (en) 1993-01-19 1997-05-20 Schneider (Usa) Inc Clad composite stent
EP0873734A2 (en) 1997-04-25 1998-10-28 Nitinol Development Corporation Shape memory alloy stent
US5913871A (en) * 1996-09-25 1999-06-22 Medtronic, Inc. Balloon modification for improved stent fixation and deployment
US5931867A (en) * 1997-04-25 1999-08-03 W.C. Heraeus Gmbh Radially expandable support device
WO1999065537A1 (en) * 1998-06-12 1999-12-23 Micro Science Medical Ag Superficial implant and surface coating for stents and other implants
WO2000068448A1 (en) * 1999-05-05 2000-11-16 Davitech, Inc. Nb-Ti-Zr-Mo ALLOYS FOR MEDICAL AND DENTAL DEVICES

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5628787A (en) 1993-01-19 1997-05-13 Schneider (Usa) Inc. Clad composite stent
US5630840A (en) 1993-01-19 1997-05-20 Schneider (Usa) Inc Clad composite stent
US5913871A (en) * 1996-09-25 1999-06-22 Medtronic, Inc. Balloon modification for improved stent fixation and deployment
EP0873734A2 (en) 1997-04-25 1998-10-28 Nitinol Development Corporation Shape memory alloy stent
US5931867A (en) * 1997-04-25 1999-08-03 W.C. Heraeus Gmbh Radially expandable support device
WO1999065537A1 (en) * 1998-06-12 1999-12-23 Micro Science Medical Ag Superficial implant and surface coating for stents and other implants
WO2000068448A1 (en) * 1999-05-05 2000-11-16 Davitech, Inc. Nb-Ti-Zr-Mo ALLOYS FOR MEDICAL AND DENTAL DEVICES

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004019822A1 (en) * 2002-08-31 2004-03-11 Boston Scientific Limited Niobium stent
EP1403390A1 (en) * 2002-09-27 2004-03-31 W.C. Heraeus GmbH & Co. KG A Nb-Zr-Ta Alloy for use in the manufacture of Stents
US8349249B2 (en) 2003-02-10 2013-01-08 Heraeus Precious Metals Gmbh & Co. Kg Metal alloy for medical devices and implants
US8403980B2 (en) 2003-02-10 2013-03-26 Heraeus Materials Technology Gmbh & Co. Kg Metal alloy for medical devices and implants
EP1444993B2 (en) † 2003-02-10 2013-06-26 W.C. Heraeus GmbH Improved metal alloy for medical devices and implants
WO2005044327A1 (en) * 2003-11-11 2005-05-19 W.C. Heraeus Gmbh Niobium-zirconium alloy for medical devices or their parts
WO2006076447A2 (en) * 2005-01-13 2006-07-20 Boston Scientific Limited Medical devices and comprising alloys
WO2006076447A3 (en) * 2005-01-13 2007-01-11 Boston Scient Scimed Inc Medical devices and comprising alloys
US7727273B2 (en) 2005-01-13 2010-06-01 Boston Scientific Scimed, Inc. Medical devices and methods of making the same
US7938854B2 (en) 2005-01-13 2011-05-10 Boston Scientific Scimed, Inc. Medical devices and methods of making the same
WO2008100852A3 (en) * 2007-02-13 2009-12-03 Abbott Cardiovascular Systems Inc. Mri compatible, radiopaque alloys for use in medical devices

Also Published As

Publication number Publication date
EP1337286A1 (en) 2003-08-27
AU2001218611A1 (en) 2002-06-11

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