WO1999065537A1 - Implantation superficielle et revetement superficiel pour extenseurs et autres implants - Google Patents

Implantation superficielle et revetement superficiel pour extenseurs et autres implants Download PDF

Info

Publication number
WO1999065537A1
WO1999065537A1 PCT/EP1999/003919 EP9903919W WO9965537A1 WO 1999065537 A1 WO1999065537 A1 WO 1999065537A1 EP 9903919 W EP9903919 W EP 9903919W WO 9965537 A1 WO9965537 A1 WO 9965537A1
Authority
WO
WIPO (PCT)
Prior art keywords
tantalum
stents
surface coating
base material
implants
Prior art date
Application number
PCT/EP1999/003919
Other languages
German (de)
English (en)
Inventor
Bernd Starck
Original Assignee
Micro Science Medical Ag
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 Micro Science Medical Ag filed Critical Micro Science Medical Ag
Priority to AU46061/99A priority Critical patent/AU4606199A/en
Publication of WO1999065537A1 publication Critical patent/WO1999065537A1/fr

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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
    • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
    • 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
    • A61L31/082—Inorganic materials
    • A61L31/088—Other specific inorganic materials not covered by A61L31/084 or A61L31/086
    • 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 surface implantation or surface coating for stents and other implants according to the preamble of claim 1
  • stents implants for healing bones (screws, plates, etc.), dental implants, cardio- and cardio-surgical implants (e.g. thoracic wires, defibrillators and pacemakers and their electrodes, coronary stents, etc.), endoprostheses, vena Cava filter, etc. used.
  • cardio- and cardio-surgical implants e.g. thoracic wires, defibrillators and pacemakers and their electrodes, coronary stents, etc.
  • endoprostheses e.g. thoracic wires, defibrillators and pacemakers and their electrodes, coronary stents, etc.
  • endoprostheses e.g. thoracic wires, defibrillators and pacemakers and their electrodes, coronary stents, etc.
  • endoprostheses e.g. thoracic wires, defibrillators and pacemakers and their electrodes, coronary stents,
  • niobium and tantalum are the two elements that have been implanted in a living body and have produced no or the least defense reactions .
  • (coronary) stents have been made from materials such as (full) tantalum, stainless steel, nitinol, etc. Since after a stent has been implanted in a previously narrowed coronary vessel, it will try to narrow again within 6 months with a probability of up to 45%, which is known as re-stenosis various manufacturers of such stents, by surface coating with gold, carbon, radioactive isotopes, etc., to achieve better results.
  • Gold and platinum are generally considered to be biocompatible.
  • stainless steel stents are electroplated with an approximately 5 ⁇ m thick gold layer.
  • Modern PVD processes are an alternative to galvanic processes. In order to achieve good adhesion to the stent surface, these must first be chemically cleaned and pickled in order to be able to remove greases, dirt residues and, last but not least, the chromium oxide layer, which protects against corrosion.
  • gold is noble compared to the stainless steel base material and builds up an electrical potential difference to it.
  • Titanium nitride is also considered to be biocompatible.
  • the coating is carried out using the PVD process. Titanium nitride is very hard (> 2500HV) and has a comparatively high elastic modulus. Similar to gold, similar problems occur or are exacerbated, because the low ductility of the layer compared to gold means that the layers tend to crack even more when the stent is expanded; In this respect, an increased risk of pitting in the base material must be taken into account.
  • stents require good elasticity with very good support strength.
  • the mechanical parameters that characterize this are expressed in the elongation at break of the material and in its modulus of elasticity.
  • austenitic stainless steel 316 L with subgroups etc. (DIN 1.4435) has a maximum elongation at break of almost 80% and a modulus of elasticity of 210 GPa. The most favorable conditions. Other materials such as titanium or tantalum are much less favorable in this regard.
  • titanium similar to tantalum, a maximum elongation at break of 30% can be set, but on average only between 10-15% Overexpansions (eg expansion through the balloon catheter) quickly lead to crack formation.
  • the modulus of elasticity for titanium is 110-120 GPa and for tantalum 160-170 GPa. Mechanically, the classic material "stainless steel” therefore has clear advantages for this application compared to the "new materials”.
  • Stainless steel stents lead to the strong formation of neointimal hyperplasia, are thrombogenic and have a thermodynamic residual risk of ion release into the surrounding biological environment.
  • Stents e.g. austenitic steel 316 L or the like have a comparatively high corrosion sensitivity.
  • the causes are, on the one hand, the relatively inhomogeneous structure and, on the other hand, the residues of "delta" ferrite in the austenite. None of the stents customary in the market was completely “delta” ferrite.
  • Coatings should remedy this.
  • a 5 ⁇ m thick gold surface is offered as a coating on the market. Gold builds up a very high pitting sensitivity to the base material, so that increased corrosion occurs especially over pores and on the rough cut surfaces. This is even stronger than with uncoated stents.
  • the present invention is based on the object of combining favorable mechanical properties of the base material with the biocompatible properties of tantalum or niobium.
  • the layers should be electrochemically compatible with the base material and must not build up any pitting potential. This happens primarily with noble and electrically conductive layers such as gold or platinum. Due to the expansion of the stent, cracking and pore formation in the layer can never be completely avoided. This can lead to increased corrosion and thus ion release of the base material via the "pitting" potential.
  • the layers must have exceptionally good adhesion to stainless steel.
  • the smallest layer flaking in vivo carries the risk of embolism.
  • the production of the layers should therefore include thermal and thermodynamic redundant safety factors. These are achieved using the PVD (Physical Vapor Depositation) process. This also minimizes the internal stresses of the layer and the base material.
  • tantalum is considered the most body-friendly metal among materials.
  • results and findings that are available on the use of tantalum.
  • tantalum is the most chemically resistant metal, in some respects it is even more stable than the precious metals.
  • tantalum has the advantage over precious metals that it tends to spontaneously self-passivate while building up an electrically insulating layer. As a result, the formation of pitting potentials can be completely ruled out.
  • the reactions of the metal tantalum (Ta) to its oxide or hydroxy oxide can partially or completely increase pores and cracks, depending on the size; this process is known as soap sealing. Corrosion tests confirm the exceptional protection that tantalum layers on stainless steel stents can offer.
  • Bipolar surfaces are formed by chemical bonding with nitrogen and oxygen to form tantalum oxynitrides, which leads to preferential adsorption of albumin from the blood. This creates the prerequisites for setting a surface that is both biocompatible and improved in terms of thrombogenicity.
  • tantalum also shows moderate x-ray contrast on stents, i.e. the stent is easily visible on the screen or image, but you can still look into the stent. This makes it easier to diagnose even stenoses in the stent than e.g. is the case with pure stainless steel stents.
  • a tantalum / tantalum ceramic layer composite is applied in several layers to the base material in layer thicknesses of up to 5 micrometers or more, so that largely continuous pores to the substrate can be avoided. But even if continuous pores occur, one can speak of chemically and electrochemically dense layers: firstly due to the above-discussed soap sealing effects of the layer and secondly due to the formation of electrically insulating passive layers. The corrosion results confirm this impressively.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Selon l'invention, il est prévu de réaliser une implantation superficielle ou un revêtement superficiel avec un matériau différent du matériau de base, pour des extenseurs ou d'autres implants qui restent de façon permanente ou provisoire dans le corps d'un homme ou d'un animal et qui comportent un corps de base, en un matériau de base, qui est formé en fonction d'exigences mécaniques ou géométriques. Etant donné que la surface ou que le revêtement superficiel est constituée de tantale ou de niobium, les propriétés mécaniques favorables du matériau de base peuvent se combiner avec les propriétés biocompatibles du tantale ou du niobium.
PCT/EP1999/003919 1998-06-12 1999-06-08 Implantation superficielle et revetement superficiel pour extenseurs et autres implants WO1999065537A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU46061/99A AU4606199A (en) 1998-06-12 1999-06-08 Superficial implant and surface coating for stents and other implants

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE29810483U DE29810483U1 (de) 1998-06-12 1998-06-12 Oberflächenimplantation oder Oberflächenbeschichtung für Stents oder andere Implantate
DE29810483.0 1998-06-12

Publications (1)

Publication Number Publication Date
WO1999065537A1 true WO1999065537A1 (fr) 1999-12-23

Family

ID=8058410

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1999/003919 WO1999065537A1 (fr) 1998-06-12 1999-06-08 Implantation superficielle et revetement superficiel pour extenseurs et autres implants

Country Status (3)

Country Link
AU (1) AU4606199A (fr)
DE (1) DE29810483U1 (fr)
WO (1) WO1999065537A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005863A1 (fr) * 2000-07-14 2002-01-24 Advanced Cardiovascular Systems, Inc. Stent radio-opaque en alliage binaire
WO2002043787A1 (fr) * 2000-11-28 2002-06-06 Fortimedix B.V. Stent
WO2002068007A1 (fr) 2001-02-26 2002-09-06 Danfoss A/S Implant et procede de modification de la surface d'un implant
WO2005065737A1 (fr) * 2003-12-24 2005-07-21 Biotronik Vi Patent Ag Marqueur radio-opaque pour implants medicaux
WO2011141169A1 (fr) 2010-05-11 2011-11-17 Medacta International S.A. Substrat pour articulations orthopédiques résistantes à l'usure, en un métal non ferreux avec un revêtement à base de nitrure
DE10145714B4 (de) * 2000-09-18 2012-07-26 Inflow Dynamics, Inc. Stent

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7101391B2 (en) 2000-09-18 2006-09-05 Inflow Dynamics Inc. Primarily niobium stent
US7402173B2 (en) 2000-09-18 2008-07-22 Boston Scientific Scimed, Inc. Metal stent with surface layer of noble metal oxide and method of fabrication
DE10357334A1 (de) * 2003-12-05 2005-07-07 Grönemeyer, Dietrich H. W., Prof. Dr.med. MR-kompatibles medizinisches Implantat

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4400408A (en) * 1980-05-14 1983-08-23 Permelec Electrode Ltd. Method for forming an anticorrosive coating on a metal substrate
US4969907A (en) * 1985-01-08 1990-11-13 Sulzer Brothers Limited Metal bone implant
US5477864A (en) * 1989-12-21 1995-12-26 Smith & Nephew Richards, Inc. Cardiovascular guidewire of enhanced biocompatibility
US5573839A (en) * 1991-04-30 1996-11-12 Saint-Gobain Vitrage International Glass substrate coated with thin multifilms for protection against solar radiation
EP0824900A2 (fr) * 1996-08-22 1998-02-25 Advanced Cardiovascular Systems, Inc. Revêtement protecteur pour un Stent muni d'une couche radio-opaque intermédiaire
FR2765095A1 (fr) * 1997-06-27 1998-12-31 Alain Guinounet Dispositif medical implantable destine a etre visse dans l'os des machoires, afin de recevoir une prothese dentaire provisoire

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4400408A (en) * 1980-05-14 1983-08-23 Permelec Electrode Ltd. Method for forming an anticorrosive coating on a metal substrate
US4969907A (en) * 1985-01-08 1990-11-13 Sulzer Brothers Limited Metal bone implant
US5477864A (en) * 1989-12-21 1995-12-26 Smith & Nephew Richards, Inc. Cardiovascular guidewire of enhanced biocompatibility
US5562730A (en) * 1989-12-21 1996-10-08 Smith & Nephew Richards, Inc. Total artificial heart device of enhanced hemocompatibility
US5573839A (en) * 1991-04-30 1996-11-12 Saint-Gobain Vitrage International Glass substrate coated with thin multifilms for protection against solar radiation
EP0824900A2 (fr) * 1996-08-22 1998-02-25 Advanced Cardiovascular Systems, Inc. Revêtement protecteur pour un Stent muni d'une couche radio-opaque intermédiaire
FR2765095A1 (fr) * 1997-06-27 1998-12-31 Alain Guinounet Dispositif medical implantable destine a etre visse dans l'os des machoires, afin de recevoir une prothese dentaire provisoire

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002005863A1 (fr) * 2000-07-14 2002-01-24 Advanced Cardiovascular Systems, Inc. Stent radio-opaque en alliage binaire
DE10145714B4 (de) * 2000-09-18 2012-07-26 Inflow Dynamics, Inc. Stent
WO2002043787A1 (fr) * 2000-11-28 2002-06-06 Fortimedix B.V. Stent
WO2002068007A1 (fr) 2001-02-26 2002-09-06 Danfoss A/S Implant et procede de modification de la surface d'un implant
US7156851B2 (en) 2001-02-26 2007-01-02 Danfoss A/S Implant and process of modifying an implant surface
WO2005065737A1 (fr) * 2003-12-24 2005-07-21 Biotronik Vi Patent Ag Marqueur radio-opaque pour implants medicaux
US8871829B2 (en) 2003-12-24 2014-10-28 Biotronik Vi Patent Ag Radio-opaque marker for medical implants
WO2011141169A1 (fr) 2010-05-11 2011-11-17 Medacta International S.A. Substrat pour articulations orthopédiques résistantes à l'usure, en un métal non ferreux avec un revêtement à base de nitrure

Also Published As

Publication number Publication date
AU4606199A (en) 2000-01-05
DE29810483U1 (de) 1999-10-14

Similar Documents

Publication Publication Date Title
DE60309281T3 (de) Verbesserte Metalllegierung für medizinische Geräte und Implantate
EP2457601B1 (fr) Composite de marqueur et implant médical doté d'un marqueur de radiographie
EP1696978B1 (fr) Marqueur radio-opaque pour implants medicaux
DE10145714B4 (de) Stent
US6287332B1 (en) Implantable, bioresorbable vessel wall support, in particular coronary stent
EP2014317B1 (fr) Implant doté d'une couche de diffusion contenant du magnésium proche de la surface et son procédé de fabrication
EP0923389B1 (fr) Implant metallique degradable in vivo
EP0388576B1 (fr) Implant métallique
EP2172580B1 (fr) Implant et methode de fabrication dudit implant
EP1891993B1 (fr) Implant métallique biocorrodable doté d'un revêtement ou d'un remplissage de cavité en copolymère Peg/Plga
EP0447744B1 (fr) Procédé pour fabriquer des surfaces ostéointégrantes d'implants du squelette aussi bien qu'un implant du squelette
DE102008043970A1 (de) Verfahren zur Herstellung einer korrosionshemmenden Beschichtung auf einem Implantat aus einer biokorrodierbaren Magnesiumlegierung sowie nach dem Verfahren hergestelltes Implantat
DE102009025511A1 (de) Implantat mit einem vom Körper resorbierbaren metallischen Werkstoff
WO1999065537A1 (fr) Implantation superficielle et revetement superficiel pour extenseurs et autres implants
DE102006038242A1 (de) Stent mit einer Struktur aus einem biokorrodierbaren metallischen Werkstoff
EP2415489B1 (fr) Implant revêtu d'agents polylactiques issu d'un alliage de magnésium biocorrodable
EP2206526A2 (fr) Pâte implantable et son utilisation
EP3068452A1 (fr) Implant à charge superficielle négative élevée
DE4303575C1 (de) Verfahren zur Herstellung apatitbeschichteter Metallimplantate
EP2332588A2 (fr) Implant biocorrodable doté d'un revêtement anticorrosion
DE10107675B4 (de) Endoprothese und Verfahren zu ihrer Herstellung
DE102012210804B4 (de) Verfahren zur Erzeugung einer bakteriziden Schicht auf einem Grundkörper aus Titan oder einer Titanbasislegierung
EP2433660B1 (fr) Implant revêtu en alliage de magnésium biocorrodable
DE60018938T2 (de) Zusammensetzung einer metallischen Kompositwerkstoffbeschichtung für Implantate
DE102018113810A1 (de) Funktionsmarkerelement und Verfahren zu dessen Herstellung

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AL AM AU BA BB BG BR CA CN CU CZ DE EE GD GE GH GM HR HU ID IL IN IS JP KE KP KR LC LK LR LS LT LV MG MK MN MX NO NZ PL RO RU SD SG SI SK SL TR TT UA UG US UZ VN YU ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW SD SL SZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: CA