US20060276876A1 - Stent, method for processing stent, and method of stenting a patient - Google Patents

Stent, method for processing stent, and method of stenting a patient Download PDF

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Publication number
US20060276876A1
US20060276876A1 US11/394,556 US39455606A US2006276876A1 US 20060276876 A1 US20060276876 A1 US 20060276876A1 US 39455606 A US39455606 A US 39455606A US 2006276876 A1 US2006276876 A1 US 2006276876A1
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United States
Prior art keywords
stent
tia16v4
nuclear spin
spin tomography
stenting
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
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US11/394,556
Inventor
Wolfgang Daum
Axel Winkel
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Invivo Germany GmbH
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Individual
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Priority to US11/394,556 priority Critical patent/US20060276876A1/en
Assigned to MRI DEVICES DAUM GMBH reassignment MRI DEVICES DAUM GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DAUM, WOLFGANG
Assigned to INVIVO GERMANY GMBH reassignment INVIVO GERMANY GMBH CHANGE OF NAME (SEE DOCUMENT FOR DETAILS). Assignors: MRI DEVICES DAUM GMBH
Publication of US20060276876A1 publication Critical patent/US20060276876A1/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S148/00Metal treatment
    • Y10S148/051Etching
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/901Method of manufacturing prosthetic device
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10TTECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00Metal working
    • Y10T29/49Method of mechanical manufacture
    • Y10T29/49002Electrical device making
    • Y10T29/4902Electromagnet, transformer or inductor
    • Y10T29/49021Magnetic recording reproducing transducer [e.g., tape head, core, etc.]
    • Y10T29/49032Fabricating head structure or component thereof
    • Y10T29/49034Treating to affect magnetic properties

Definitions

  • This invention relates to the use of a material in claim 1 and a process in claims 3 and 5 .
  • cardiovascular stents that are able to adequately prop open the vessel, that can be accurately positioned and that, and this is new—can be viewed with nuclear spin tomography.
  • Traditional stents are made of stainless steel and show distinct image distortions, so called artifacts. These artifacts occur when materials with high magnetic susceptibility are used.
  • a goal of the invention is to show means by which the occurrence of artifacts in combination with the stents and nuclear spin tomography can be avoided.
  • the above named alloy according to ASTM Grade 9 is harder than an alloy according to ASTM Grade 5 or ISO 3.765 or 3.7165. This would have the following components: 90% titanium, 6% aluminum, and 4% vanadium.
  • the material is more flexible than the so-called ASTM grade 9 material and is therefore more suitable for expanding a stent with the help of a balloon catheter.
  • Materials that are made to be artifact free but created with tools containing magnetizing components after processing show an increase in screen artifacts which rubbed off the tools.
  • a reduction of surface magnetism can be achieved through dipping in etching solutions which etches the materials the tools are made of.
  • the rub-off from the tools is eliminated by the wet chemical etching solution.
  • Such an etching solution that removes the iron impurities consists for example of 3 parts hydrochloric acid and 2 parts saltpeter acid and can be further reduced with additional parts water in the etching process.
  • Stents manufactured in the manner here described can be ideally observed in nuclear spin tomography units in magnetic flux density >1.0 Testa. It was possible, for example with an unexpanded stent having a diameter of 1 mm, that was balloon expanded to a diameter of 4 mm, to clearly see all the stent struts, the so-called strats. It was also possible to get a good look inside the expanded stent. So-called in-stent-restenose in the interior of the stent can be seen when a stent has been treated in this manner.

Abstract

The subject invention pertains instruments for use in nuclear spin tomography comprising a metal alloy comprising aluminum, vanadium, and titanium. In a specific embodiment, the subject invention relates to cardiovascular stents which can exhibit a low incidence of artifacts and are viewable in a nuclear spin tomography unit. The subject invention also pertains to a method for processing instruments for use in nuclear spin tomography. Spin processing can comprise application of a wet chemical etching solution. In a specific embodiment, the wet chemical etching solution can comprise three parts hydrochloric acid and two parts saltpeter acid.

Description

    CROSS-REFERENCE TO RELATED APPLICATION
  • This application is a divisional application of U.S. patent application Ser. No. 10/851,931, filed May 21, 2004, which is a divisional application of U.S. patent application Ser. No. 10/091,988, filed Mar. 5, 2002, now U.S. Pat. No. 6,780,338, which claims the benefit of German Application Serial No. 20104145.6, filed Mar. 9, 2001, all of which are hereby incorporated by reference herein in their entirety, including any figures, tables, or drawings.
  • DESCRIPTION
  • This invention relates to the use of a material in claim 1 and a process in claims 3 and 5. In today's stent technology it is desirable to use cardiovascular stents that are able to adequately prop open the vessel, that can be accurately positioned and that, and this is new—can be viewed with nuclear spin tomography. Traditional stents are made of stainless steel and show distinct image distortions, so called artifacts. These artifacts occur when materials with high magnetic susceptibility are used.
  • A goal of the invention is to show means by which the occurrence of artifacts in combination with the stents and nuclear spin tomography can be avoided.
  • The solution is recapitulated in claims 1 through 5.
  • An alloy of 3 percent aluminum by weight and 2.5 percent vanadium by weight, with the remainder being titanium, known as material TIA13V2.5 or material No. 3.7194 or 253.7195 (ASTM Grade 9), shows especially few image artifacts and has sufficient hardness to be suitable for interventional instruments used in nuclear spin tomography.
  • The above named alloy according to ASTM Grade 9 is harder than an alloy according to ASTM Grade 5 or ISO 3.765 or 3.7165. This would have the following components: 90% titanium, 6% aluminum, and 4% vanadium. The material is more flexible than the so-called ASTM grade 9 material and is therefore more suitable for expanding a stent with the help of a balloon catheter.
  • Materials that are made to be artifact free but created with tools containing magnetizing components after processing show an increase in screen artifacts which rubbed off the tools. A reduction of surface magnetism can be achieved through dipping in etching solutions which etches the materials the tools are made of. The rub-off from the tools is eliminated by the wet chemical etching solution. Such an etching solution that removes the iron impurities consists for example of 3 parts hydrochloric acid and 2 parts saltpeter acid and can be further reduced with additional parts water in the etching process.
  • Stents manufactured in the manner here described can be ideally observed in nuclear spin tomography units in magnetic flux density >1.0 Testa. It was possible, for example with an unexpanded stent having a diameter of 1 mm, that was balloon expanded to a diameter of 4 mm, to clearly see all the stent struts, the so-called strats. It was also possible to get a good look inside the expanded stent. So-called in-stent-restenose in the interior of the stent can be seen when a stent has been treated in this manner.

Claims (23)

1-5. (canceled)
6. A method for control of in-stent-restenosis, comprising:
positioning a stent in a vessel, wherein the stent comprises TIA13V2.5; and
viewing in-stent-restenosis within an inner lumen of the stent with nuclear spin tomography, wherein the TIA13V2.5 exhibits a low incidence of artifacts in nuclear spin tomography, wherein viewing in-stent-restenosis within the inner lumen of the stent with nuclear spin tomography is useful for control of in-stent-restenosis.
7. The method according to claim 6,
wherein the stent consists essentially entirely of TIA13V2.5.
8. The method according to claim 6, wherein TIA13V2.5 has the following composition by weight:
up to 0.08% C; up to 0.03% N2; up to 0.15% O2; 2.0% to 3.0% V; 2.5% to 3.5% Al; up to 0.25% Fe; up to 0.015% H2; and the balance Ti.
9. The method according to claim 7,
wherein TIA13V2.5 has the following composition by weight:
up to 0.08% C; up to 0.03% N2; up to 0.15% O2; 2.0% to 3.0% V; 2.5% to 3.5% Al; up to 0.25% Fe; up to 0.015% H2; and the balance Ti.
10. A method for control of in-stent-restenosis, comprising:
positioning a stent in a vessel, wherein the stent comprises TIA16V4; and
viewing in-stent-restenosis within an inner lumen of the stent with nuclear spin tomography, wherein the TIA16V4 exhibits a low incidence of artifacts in nuclear spin tomography, wherein viewing in-stent-restenosis within the inner lumen of the stent with nuclear spin tomography is useful for control of in-stent-restenosis.
11. The method according to claim 10,
wherein the stent is expandable with a balloon catheter.
12. The method according to claim 10,
wherein the stent consists essentially entirely of TIA16V4.
13. The method according to claim 10,
wherein the TIA16V4 has the following composition by weight:
up to 0.08% C; up to 0.05% N2; up to 0.2% O2; 3.5% to 4.5% V; 5.5% to 6.75% Al; up to 0.4% Fe; up to 0.015% H2; and the balance Ti.
14. The method according to claim 12,
wherein the TIA16V4 has the following composition by weight:
up to 0.08% C; up to 0.05% N2; up to 0.2% O2; 3.5% to 4.5% V; 5.5% to 6.75% Al; up to 0.4% Fe; up to 0.015% H2; and the balance Ti.
15. A method of stenting a patient, comprising:
stenting a patient with a stent, wherein the stent comprises:
TIA13V2.5, wherein the TIA13V2.5 exhibits a low incidence of artifacts in nuclear spin tomography.
16. The method according to claim 15,
wherein the stent consists essentially entirely of TIA13V2.5.
17. The method according to claim 15,
wherein TIA13V2.5 has the following composition by weight:
up to 0.08% C; up to 0.03% N2; up to 0.15% O2; 2.0% to 3.0% V; 2.5% to 3.5% Al; up to 0.25% Fe; less than 0.015% H2; and the balance Ti.
18. The method according to claim 16,
wherein TIA13V2.5 has the following composition by weight:
up to 0.08% C; up to 0.03% N2; up to 0.15% O2; 2.0% to 3.0% V; 2.5% to 3.5% Al; up to 0.25% Fe; up to 0.015% H2; and the balance Ti.
19. A method of stenting a patient, comprising:
stenting a patient with a stent, wherein the stent comprises TIA16V4, wherein the TIA16V4 exhibits a low incidence of artifacts in nuclear spin tomography.
20. The method according to claim 19,
wherein the stent is expandable with a balloon catheter.
21. The method according to claim 19,
wherein the stent consists essentially entirely of TIA16V4.
22. The method according to claim 19,
wherein the TIA16V4 has the following composition by weight:
up to 0.08% C; up to 0.05% N2; up to 0.2% O2; 3.5% to 4.5% V; 5.5% to 6.75% Al; up to 0.4% Fe; up to 0.015% H2; and the balance Ti.
23. The method according to claim 21,
wherein the TIA16V4 has the following composition by weight:
up to 0.08% C; up to 0.05% N2; up to 0.2% O2; 3.5% to 4.5% V; 5.5% to 6.75% Al; up to 0.4% Fe; up to 0.015% H2; and the balance Ti.
24. A method of stenting a patient, comprising:
stenting a patient with a stent processed with tools containing magnetizing components, wherein prior to stenting the patient exposing the surface of the stent processed with tools containing magnetizing components to an etching solution that etches the magnetizing components, wherein exposing the surface of the stent processed with tools containing magnetizing components reduces surface magnetism of the stent, wherein reducing surface magnetism of the stent reduces the occurrence of artifacts from the stent in nuclear spin tomography.
25. The method according to claim 24,
wherein the etching solution etches iron impurities.
26. The method according to claim 25,
wherein the etching solution comprises:
3 parts hydrochloric acid; and
2 parts saltpeter acid.
27. The method according to claim 26,
wherein the etching solution further comprises water.
US11/394,556 2001-03-09 2006-03-31 Stent, method for processing stent, and method of stenting a patient Abandoned US20060276876A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US11/394,556 US20060276876A1 (en) 2001-03-09 2006-03-31 Stent, method for processing stent, and method of stenting a patient

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
DE20104145.6 2001-03-09
DE20104145U DE20104145U1 (en) 2001-03-09 2001-03-09 Cardiovascular stent
US10/091,988 US6780338B2 (en) 2001-03-09 2002-03-05 Method for processing a stent processed with tools containing magnetizing components
US10/851,931 US20040211491A1 (en) 2001-03-09 2004-05-21 Stent, method for processing stent, and method of stenting a patient
US11/394,556 US20060276876A1 (en) 2001-03-09 2006-03-31 Stent, method for processing stent, and method of stenting a patient

Related Parent Applications (1)

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US10/851,931 Division US20040211491A1 (en) 2001-03-09 2004-05-21 Stent, method for processing stent, and method of stenting a patient

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US20060276876A1 true US20060276876A1 (en) 2006-12-07

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US10/091,988 Expired - Lifetime US6780338B2 (en) 2001-03-09 2002-03-05 Method for processing a stent processed with tools containing magnetizing components
US10/851,931 Abandoned US20040211491A1 (en) 2001-03-09 2004-05-21 Stent, method for processing stent, and method of stenting a patient
US11/394,556 Abandoned US20060276876A1 (en) 2001-03-09 2006-03-31 Stent, method for processing stent, and method of stenting a patient

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US10/851,931 Abandoned US20040211491A1 (en) 2001-03-09 2004-05-21 Stent, method for processing stent, and method of stenting a patient

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Families Citing this family (5)

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Publication number Priority date Publication date Assignee Title
WO2006036786A2 (en) * 2004-09-27 2006-04-06 Cook Incorporated Mri compatible metal devices
US20080249607A1 (en) * 2005-09-20 2008-10-09 Thomas Jay Webster Biocompatable Nanophase Materials
JP2008036076A (en) * 2006-08-04 2008-02-21 Japan Health Science Foundation Balloon-expandable stent and its production method
US8380311B2 (en) * 2006-10-31 2013-02-19 Medtronic, Inc. Housing for implantable medical device
US20080103543A1 (en) * 2006-10-31 2008-05-01 Medtronic, Inc. Implantable medical device with titanium alloy housing

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US5733326A (en) * 1996-05-28 1998-03-31 Cordis Corporation Composite material endoprosthesis
US6010445A (en) * 1997-09-11 2000-01-04 Implant Sciences Corporation Radioactive medical device and process
US6183508B1 (en) * 1996-02-08 2001-02-06 Schneider Inc Method for treating a vessel with a titanium alloy stent
US6183409B1 (en) * 1998-02-10 2001-02-06 Implant Sciences Corporation Soft x-ray emitting radioactive stent
US6258182B1 (en) * 1998-03-05 2001-07-10 Memry Corporation Pseudoelastic β titanium alloy and uses therefor
US6325824B2 (en) * 1998-07-22 2001-12-04 Advanced Cardiovascular Systems, Inc. Crush resistant stent
US6527938B2 (en) * 2001-06-21 2003-03-04 Syntheon, Llc Method for microporous surface modification of implantable metallic medical articles
US6551341B2 (en) * 2001-06-14 2003-04-22 Advanced Cardiovascular Systems, Inc. Devices configured from strain hardened Ni Ti tubing

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US6183508B1 (en) * 1996-02-08 2001-02-06 Schneider Inc Method for treating a vessel with a titanium alloy stent
US5733326A (en) * 1996-05-28 1998-03-31 Cordis Corporation Composite material endoprosthesis
US6010445A (en) * 1997-09-11 2000-01-04 Implant Sciences Corporation Radioactive medical device and process
US6183409B1 (en) * 1998-02-10 2001-02-06 Implant Sciences Corporation Soft x-ray emitting radioactive stent
US6258182B1 (en) * 1998-03-05 2001-07-10 Memry Corporation Pseudoelastic β titanium alloy and uses therefor
US6325824B2 (en) * 1998-07-22 2001-12-04 Advanced Cardiovascular Systems, Inc. Crush resistant stent
US6551341B2 (en) * 2001-06-14 2003-04-22 Advanced Cardiovascular Systems, Inc. Devices configured from strain hardened Ni Ti tubing
US6527938B2 (en) * 2001-06-21 2003-03-04 Syntheon, Llc Method for microporous surface modification of implantable metallic medical articles

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US20040211491A1 (en) 2004-10-28
DE20104145U1 (en) 2002-10-31
US20030078675A1 (en) 2003-04-24
US6780338B2 (en) 2004-08-24

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