US20040211491A1 - 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
US20040211491A1
US20040211491A1 US10/851,931 US85193104A US2004211491A1 US 20040211491 A1 US20040211491 A1 US 20040211491A1 US 85193104 A US85193104 A US 85193104A US 2004211491 A1 US2004211491 A1 US 2004211491A1
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United States
Prior art keywords
stent
nuclear spin
artifacts
spin tomography
subject invention
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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US10/851,931
Inventor
Wolfgang Daum
Axel Winkel
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Invivo Germany GmbH
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to US10/851,931 priority Critical patent/US20040211491A1/en
Publication of US20040211491A1 publication Critical patent/US20040211491A1/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
Priority to US11/394,556 priority 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

  • the subject invention relates to a stent which exhibits a low incidence of artifacts in nuclear spin tomography, and to a process for treating stents that are processed with tools containing magnetizing components such as iron.
  • cardiovascular stents that are able to adequately prop open the vessel and that can be accurately positioned. It would be desirable to use stents that can be viewed with nuclear spin tomography.
  • traditional stents are made of stainless steel and show distinct image distortions, or so called artifacts. These artifacts occur when materials with high magnetic susceptibility are used.
  • the subject invention relates to a stent with respect to which the occurrence of artifacts in nuclear spin tomography can be reduced or avoided.
  • the subject invention also pertains to the etching of stents, incorporating titanium and/or titanium alloys, that have been processed with tools containing magnetizing components.
  • etching the stent in an etch solution that etches the magnetizing component materials of the tools can reduce the amount of the magnetizing component materials of the tools on the surface of the stent and, therefore, reduce the incidence of artifacts from the stent.
  • the subject invention can also be useful for the control of in-stent-restenosis by allowing imaging under nuclear spin tomography to see in-stent-restenosis in the interior of the subject stent.
  • the subject stent can incorporate an alloy of 3 percent aluminum by weight and 2.5 percent vanadium by weight, with the remainder being titanium, known as material TIAl3V2.5 or material No. 3.7194 or 253.7195 (ASTM Grade 9), where ASTM is the American Society for Testing and Materials.
  • material TIAl3V2.5 also known as Ti3Al2.5V and ASTM Grade 9
  • Table I TABLE I Content (weight %) C up to 0.08% N 2 up to 0.03% O 2 up to 0.15% V 2.0-3.0% Al 2.5-3.5% Fe up to 0.25% H 2 up to 0.015% Ti balance
  • the subject stent can incorporate an alloy referred to as ASTM Grade 5 (also known as ISO 3.765 or 3.7165).
  • ASTM Grade 9 is harder than an alloy according to ASTM Grade 5, which can have the following components: 90% titanium, 6% aluminum, and 4% vanadium.
  • ASTM 5 the composition of titanium alloy known as ASTM 5 is shown in Table II. TABLE II Content (weight %) C up to 0.08% N 2 up to 0.05% O 2 up to 0.2% V 3.5-4.5% Al 5.5-6.75% Fe up to 0.4% H 2 up to 0.015% Ti balance
  • the ASTM Grade 5 material is more flexible than the ASTM grade 9 material and is, therefore, more suitable for expanding a stent with the help of a balloon catheter.
  • Stents incorporating materials that are made to be artifact free, that are created with tools containing magnetizing components typically show an increase in screen artifacts. This increase in artifacts is due to some amount of the tool material rubbing off the tool onto the stent during the processing of the stent with the tools.
  • a reduction of surface magnetism of the stent can be achieved through dipping in etching solutions that etch 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 iron impurities can consist of, for example, 3 parts hydrochloric acid and 2 parts saltpeter acid. This etching solution can be further reduced with additional parts water in the etching process.
  • Stents manufactured in accordance with the subject invention in the manner described herein, can be ideally observed in nuclear spin tomography units incorporating a magnetic flux density>1.0 Testa.
  • unexpanded stent having a diameter of 1 mm was balloon expanded to a diameter of 4 mm, and it was possible to clearly see all the stent struts, or the so-called strats. It was also possible to get a good look inside the expanded stent.
  • so-called in-stent-restenosis in the interior, or inner lumen, of the stent can be seen when a stent has been treated in accordance with the subject invention.
  • the ability to see in-stent-restenosis in the interior of the stent can be useful for the control of in-stent-restenosis.

Abstract

The subject invention relates to a stent with respect to which the occurrence of artifacts in nuclear spin tomography can be reduced or avoided. The subject invention also pertains to the etching of stents, incorporating titanium and/or titanium alloys, that have been processed with tools containing magnetizing components. The subject invention can also be useful for the control of in-stent-restenosis by allowing imaging under nuclear spin tomography to see in-stent-restenosis in the interior of the subject stent.

Description

    CROSS-REFERENCE TO RELATED APPLICATION
  • This application is a divisional of U.S. patent application Ser. No. 10/091,988, filed Mar. 5, 2002, which claims the benefit of German Application Serial No. 20104145.6, filed Mar. 9, 2001.[0001]
  • BACKGROUND OF INVENTION
  • The subject invention relates to a stent which exhibits a low incidence of artifacts in nuclear spin tomography, and to a process for treating stents that are processed with tools containing magnetizing components such as iron. [0002]
  • In today's stent technology it is desirable to use cardiovascular stents that are able to adequately prop open the vessel and that can be accurately positioned. It would be desirable to use stents that can be viewed with nuclear spin tomography. However, traditional stents are made of stainless steel and show distinct image distortions, or so called artifacts. These artifacts occur when materials with high magnetic susceptibility are used. [0003]
  • BRIEF SUMMARY OF THE INVENTION
  • The subject invention relates to a stent with respect to which the occurrence of artifacts in nuclear spin tomography can be reduced or avoided. The subject invention also pertains to the etching of stents, incorporating titanium and/or titanium alloys, that have been processed with tools containing magnetizing components. As processing the stents with tools containing magnetizing components can result in some amount of the tool material rubbing off the tools onto the stent, etching the stent in an etch solution that etches the magnetizing component materials of the tools can reduce the amount of the magnetizing component materials of the tools on the surface of the stent and, therefore, reduce the incidence of artifacts from the stent. [0004]
  • The subject invention can also be useful for the control of in-stent-restenosis by allowing imaging under nuclear spin tomography to see in-stent-restenosis in the interior of the subject stent.[0005]
  • DETAILED DESCRIPTION OF THE INVENTION
  • In a specific embodiment, the subject stent can incorporate an alloy of 3 percent aluminum by weight and 2.5 percent vanadium by weight, with the remainder being titanium, known as material TIAl3V2.5 or material No. 3.7194 or 253.7195 (ASTM Grade 9), where ASTM is the American Society for Testing and Materials. As known in the art, the composition of titanium alloy TIAl3V2.5, also known as Ti3Al2.5V and ASTM Grade 9, is shown in Table I. [0006]
    TABLE I
    Content (weight %)
    C  up to 0.08%
    N2  up to 0.03%
    O2  up to 0.15%
    V 2.0-3.0%
    Al 2.5-3.5%
    Fe  up to 0.25%
    H2 up to 0.015%
    Ti balance
  • The use of TIAl3V2.5 to produce this embodiment of the subject stent results in a stent that produces especially few image artifacts and has sufficient hardness to be suitable for interventional instruments used in nuclear spin tomography. [0007]
  • In another specific embodiment, the subject stent can incorporate an alloy referred to as ASTM Grade 5 (also known as ISO 3.765 or 3.7165). The alloy according to ASTM Grade 9 is harder than an alloy according to ASTM Grade 5, which can have the following components: 90% titanium, 6% aluminum, and 4% vanadium. As known in the art, the composition of titanium alloy known as ASTM 5 is shown in Table II. [0008]
    TABLE II
    Content (weight %)
    C  up to 0.08%
    N2  up to 0.05%
    O2  up to 0.2%
    V  3.5-4.5%
    Al 5.5-6.75%
    Fe  up to 0.4%
    H2 up to 0.015%
    Ti balance
  • The ASTM Grade 5 material is more flexible than the ASTM grade 9 material and is, therefore, more suitable for expanding a stent with the help of a balloon catheter. [0009]
  • Stents, incorporating materials that are made to be artifact free, that are created with tools containing magnetizing components typically show an increase in screen artifacts. This increase in artifacts is due to some amount of the tool material rubbing off the tool onto the stent during the processing of the stent with the tools. A reduction of surface magnetism of the stent can be achieved through dipping in etching solutions that etch the materials the tools are made of. The rub-off from the tools is eliminated by the wet chemical etching solution. In a specific embodiment, such an etching solution, that removes iron impurities can consist of, for example, 3 parts hydrochloric acid and 2 parts saltpeter acid. This etching solution can be further reduced with additional parts water in the etching process. [0010]
  • Stents manufactured in accordance with the subject invention, in the manner described herein, can be ideally observed in nuclear spin tomography units incorporating a magnetic flux density>1.0 Testa. In a specific embodiment, unexpanded stent having a diameter of 1 mm was balloon expanded to a diameter of 4 mm, and it was possible to clearly see all the stent struts, or the so-called strats. It was also possible to get a good look inside the expanded stent. Advantageously, so-called in-stent-restenosis in the interior, or inner lumen, of the stent can be seen when a stent has been treated in accordance with the subject invention. The ability to see in-stent-restenosis in the interior of the stent can be useful for the control of in-stent-restenosis. [0011]

Claims (11)

1-5. (canceled).
6. A stent, comprising:
TIAl3V2.5, wherein the TIAl3V2.5 exhibits a low incidence of artifacts in nuclear spin tomography.
7. The stent according to claim 1, wherein the stent consists essentially entirely of TIAl3V2.5.
8. The stent according to claim 1, wherein the stent is viewable in nuclear spin tomography.
9. The stent according to claim 1, wherein TIAl3V2.5 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.
10. The stent according to claim 2, wherein TIAl3V2.5 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.
11. A stent, comprising:
TIAl6V4, wherein the TIAl6V4 exhibits a low incidence of artifacts in nuclear spin tomography.
12. The stent according to claim 6, wherein the stent is expandable with a balloon catheter.
13. The stent accrediting to claim 6, wherein the stent consists essentially entirety of TIAl6V4.
14. The stent according to claim 6, wherein the TIAl6V4 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. The stent according to claim 8, wherein the TIAl6V4 has the following
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.
US10/851,931 2001-03-09 2004-05-21 Stent, method for processing stent, and method of stenting a patient Abandoned US20040211491A1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
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

Applications Claiming Priority (4)

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

Related Parent Applications (1)

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US10/091,988 Division US6780338B2 (en) 2001-03-09 2002-03-05 Method for processing a stent processed with tools containing magnetizing components

Related Child Applications (1)

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US11/394,556 Division 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
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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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008036076A (en) * 2006-08-04 2008-02-21 Japan Health Science Foundation Balloon-expandable stent and its production method
US20080103543A1 (en) * 2006-10-31 2008-05-01 Medtronic, Inc. Implantable medical device with titanium alloy housing

Families Citing this family (3)

* Cited by examiner, † Cited by third party
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
US8380311B2 (en) * 2006-10-31 2013-02-19 Medtronic, Inc. Housing for implantable medical device

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US5895401A (en) * 1995-08-24 1999-04-20 Daum Gmbh Controlled-artifact magnetic resonance instruments
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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US5733326A (en) * 1996-05-28 1998-03-31 Cordis Corporation Composite material endoprosthesis

Patent Citations (8)

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Publication number Priority date Publication date Assignee Title
US5895401A (en) * 1995-08-24 1999-04-20 Daum Gmbh Controlled-artifact magnetic resonance instruments
US6183508B1 (en) * 1996-02-08 2001-02-06 Schneider Inc Method for treating a vessel with a titanium alloy stent
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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2008036076A (en) * 2006-08-04 2008-02-21 Japan Health Science Foundation Balloon-expandable stent and its production method
US20080103543A1 (en) * 2006-10-31 2008-05-01 Medtronic, Inc. Implantable medical device with titanium alloy housing

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Publication number Publication date
US20060276876A1 (en) 2006-12-07
DE20104145U1 (en) 2002-10-31
US20030078675A1 (en) 2003-04-24
US6780338B2 (en) 2004-08-24

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