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WO2008032370A1 - Endoprothèse vasculaire - Google Patents

Endoprothèse vasculaire Download PDF

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Publication number
WO2008032370A1
WO2008032370A1 PCT/JP2006/318142 JP2006318142W WO2008032370A1 WO 2008032370 A1 WO2008032370 A1 WO 2008032370A1 JP 2006318142 W JP2006318142 W JP 2006318142W WO 2008032370 A1 WO2008032370 A1 WO 2008032370A1
Authority
WO
WIPO (PCT)
Prior art keywords
sample
metal alloy
stent
noble metal
gold
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.)
Ceased
Application number
PCT/JP2006/318142
Other languages
English (en)
Japanese (ja)
Inventor
Kenichi Shimodaira
Akira Shinjo
Chiaki Abe
Takao Hanawa
Ikuo Kobayashi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tokyo Medical and Dental University NUC
Homs Engineering Inc
Original Assignee
Tokyo Medical and Dental University NUC
Homs Engineering Inc
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 Tokyo Medical and Dental University NUC, Homs Engineering Inc filed Critical Tokyo Medical and Dental University NUC
Priority to PCT/JP2006/318142 priority Critical patent/WO2008032370A1/fr
Publication of WO2008032370A1 publication Critical patent/WO2008032370A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • 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
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C5/00—Alloys based on noble metals
    • C22C5/02—Alloys based on gold

Definitions

  • the present invention relates to a stent.
  • Patent Document 1 a stent manufactured from a noble metal alloy containing gold and palladium has been disclosed (see, for example, Patent Document 1). O Since conventional stents are mainly composed of noble metals, MRI images Low turbulence, high radiopacity, high mechanical strength, excellent wettability, and good biocompatibility.
  • Patent Document 1 Japanese Translation of Special Publication 2004-505651
  • the present invention has been made in view of the circumstances as described above, and provides a stent with higher chemical stability and blood compatibility (antithrombogenicity) than conventional stents. With the goal.
  • the stent of the present invention is a stent in which a precious metal alloy force having both gold and palladium force is produced, and the precious metal alloy has a gold content (mol%) in the precious metal alloy of X
  • X1Z (X1 + X2) is 0.65 or more and the gold content is higher than that of the conventional stent.
  • Chemical stability It is possible to provide a stent with high blood compatibility and high blood compatibility (antithrombogenicity).
  • the weight ratio of gold to palladium is 3: 1 (gold 75% by weight, of palladium 25% by weight) to 0 5:. 1 (gold 33 wt%, palladium 67 wt 0/0 (See claim 3 of Patent Document 1) force If expressed in terms of mol ratio, the molar ratio of gold to palladium is 61.8: 38. 2-21. 3 : Noble metal alloy between 78.7 is used, indicating that the stent of the present invention has a higher gold content than the conventional stent.
  • the noble metal alloy preferably satisfies the following formula (2).
  • X1Z (X1 + X2) is 0.68 or more as described above, and the gold content is higher than that of the conventional stent. It is possible to provide a hemorrhoid stent that is highly stable and has high blood compatibility (antithrombogenicity).
  • the noble metal alloy preferably has a structure in which an Au Pd phase is precipitated in an alloy matrix composed of gold and palladium.
  • the noble metal alloy is preferably a noble metal alloy produced by performing an aging heat treatment.
  • the Au Pd phase is contained in the alloy matrix composed of gold and palladium.
  • the noble metal alloy preferably satisfies the following formula (3):
  • the noble metal alloy preferably satisfies the following formula (4).
  • XlZ (XI + X2) is 0.79 or less as described above.
  • the gold content is slightly lower than that of the stent described in (5) above, and a stent having higher mechanical strength than the stent described in (5) can be provided.
  • FIG. 1 is a phase diagram of a gold / palladium binary system.
  • FIG. 2 is a diagram showing the external appearance of a button-shaped ingot.
  • FIG. 3 is a view showing the appearance of a rolled body.
  • FIG. 4 is a diagram showing an external appearance after electric discharge machining of a rolled body.
  • FIG. 5 is a view showing dimensions of a dissolution test specimen, a blood compatibility (antithrombogenicity) test specimen, and a tensile test specimen.
  • FIG. 6 is a diagram for explaining an anodic polarization test apparatus.
  • FIG. 7 is a diagram showing the results of an anodic polarization test for Sample 5.
  • FIG. 1 is a gold / palladium binary phase diagram.
  • the stent according to Embodiment 1 is a stent in which a noble metal alloy force that also has gold and palladium forces is manufactured, and the noble metal alloy has a gold content (mol%) in the noble metal alloy of XI, When the palladium content (mol%) is X2, the following formula (3) Meet.
  • the stent according to Embodiment 1 is a stent manufactured with a noble metal alloy force in a range indicated by an arrow A in FIG.
  • the stent according to Embodiment 1 also has a conventional stent (noble metal alloy strength in the range indicated by arrow E in Fig. 1).
  • the conventional stent is exclusively a multi-element precious metal alloy. Therefore, the range cannot be determined on the binary system phase diagram as shown in Fig. 1.However, if the range is specified using the weight ratio of gold in the noble metal alloy, it is indicated by arrow E in Fig. 1. Since the gold content is higher than that of conventional stents, it has higher chemical stability and higher blood compatibility (antithrombogenicity) than conventional stents, resulting in a stent.
  • the stent according to Embodiment 1 has a higher gold content than the conventional stent, so that the mechanical strength may be reduced.
  • X1 / (X1 + Since X2) is 0.88 or less, the gold content does not become extremely high, and sufficient mechanical strength can be maintained.
  • the stent according to the second embodiment is a stent in which a precious metal alloy force having both gold and palladium force is produced, and the precious metal alloy has a gold content (mol%) in the precious metal alloy as XI, and the palladium content in the precious metal alloy.
  • the amount (mol%) is X2
  • the following formula (4) is satisfied.
  • the stent according to Embodiment 2 is a stent manufactured with a precious metal alloy force in a range indicated by an arrow B in FIG.
  • the stent according to the second embodiment has a higher gold content than the conventional stent, and therefore, as in the case of the stent according to the first embodiment, the chemical stability is higher than that of the conventional stent. It has high blood compatibility (antithrombogenicity) and is a stent.
  • the stent according to the third embodiment is a stent in which a precious metal alloy force having both gold and palladium force is produced, and the precious metal alloy has a gold content (mol%) in the precious metal alloy as XI, and the palladium content in the precious metal alloy.
  • the amount (mol%) is X2
  • the following formula (3) is satisfied.
  • the stent according to Embodiment 3 is a stent in which a precious metal alloy force in the range indicated by arrow A in Fig. 1 is also produced, as in the case of the stent according to Embodiment 1.
  • the stent according to Embodiment 3 differs from the stent according to Embodiment 1 in the structure of the noble metal alloy.
  • the noble metal alloy has a structure in which an Au Pd phase is precipitated in an alloy matrix composed of gold and palladium. And noble metal alloys
  • a noble metal alloy produced by performing an aging heat treatment is provided.
  • the stent according to the third embodiment is different from the stent according to the first embodiment in the structure of the noble metal alloy.
  • the noble metal alloy is a noble metal.
  • the gold content (mol%) in the metal alloy is XI
  • the palladium content (mol%) in the noble metal alloy is X2
  • the above formula (3) is satisfied and the gold content is higher than that of the conventional stent. Due to the high amount, the stent has higher chemical stability and higher blood compatibility (antithrombogenicity) than conventional stents.
  • the noble metal alloy has a structure in which an Au Pd phase is precipitated in an alloy matrix composed of gold and palladium. For this reason,
  • the stent according to the third embodiment has a mechanical strength that is higher than that of the stent according to the first embodiment because the mechanical strength of the noble metal alloy is improved.
  • the noble metal alloy is a noble metal alloy produced by performing an aging heat treatment
  • Au Pd is contained in the alloy matrix that also has gold and palladium power as described above. It becomes a noble metal alloy having a structure in which phases are precipitated.
  • the stent of the present invention is sufficiently high !, chemical stability, sufficiently high, blood compatibility (antithrombogenicity) and In order to show that it has a sufficiently high mechanical strength, the following experiment was conducted.
  • Table 1 is a table showing the composition of the noble metal alloy sample used in the examples.
  • Fig. 2 shows the appearance of the button-shaped ingot.
  • FIG. 3 is a diagram showing the appearance of the rolled body.
  • FIG. 4 is a view showing an external appearance after the rolled body is subjected to electric discharge machining.
  • FIG. 5 is a diagram showing dimensions of a dissolution test specimen, a blood compatibility (antithrombogenicity) test specimen, and a tensile test specimen.
  • test piece for dissolution test a test piece for blood compatibility (antithrombogenicity) test, and a test piece for tensile test were prepared by wire-cut electric discharge machining (see FIGS. 4 and 5). .
  • Example 1 is an example (dissolution test) for showing that the stent of the present invention has sufficiently high chemical stability.
  • the former is a material that is already on the market as a material for self-expanding stents, and the latter is a material that has been used in many ways as a biomaterial for orthopedics.
  • each sample (Sample 1 to Sample 5) was taken out from the solution, and the concentration of the metal ion dissolved in the remaining solution was measured by ICP emission spectroscopic analysis (PS-1000, Leeman Labs). . The measured ion concentration was compared in terms of the amount of elution per unit sample surface area. In addition, the surface condition of the sample taken out was observed.
  • Table 2 shows the results of a 3-week dissolution test in a 9% NaCl aqueous solution.
  • ND indicates that no elution was observed within the ICP detection limit range (approximately OOlmgZm 2 or more).
  • each of Comparative Sample 1 and Comparative Sample 2 is 8. 1. Force at which elution of metal ions of 1.8 mgZm 2 was observed From Sample 1 to Sample 5, elution within the detection limit range of ICP was not observed. In addition, Sample 1 to Sample 5 showed no signs of dissolution even in appearance.
  • Example 2 is an example (anodic polarization test) for showing that the stent of the present invention has sufficiently high chemical stability, as in Example 1.
  • FIG. 6 is a diagram for explaining the anodic polarization test apparatus.
  • FIG. 6 (a) is a diagram showing the external appearance of the anode polarization test apparatus, and
  • FIG. 6 (b) is a diagram for explaining the sample holder.
  • a dissolution test specimen (diameter 10 mm, thickness lmm) (see Fig. 5) similar to that used in Example 1 was used after mirror polishing.
  • the anodic polarization test was conducted in 0.9% NaCl aqueous solution at 37 ° C. N After degassing with gas bubble for 30 minutes, potentio
  • anodic polarization test was conducted at a sweep rate of 2 X 10 _3 Vs _1 .
  • a platinum electrode was used as the counter electrode, and a saturated calomel electrode (SCE) was used as the reference electrode.
  • SCE saturated calomel electrode
  • an anodic polarization test was also performed on gold (pure gold) (comparative sample 1) and copper (comparative sample 2).
  • FIG. 7 is a diagram showing the results of an anode polarization test for sample 5 having the highest palladium concentration content among samples 1 to 5.
  • 1. OV (vs. SCE) force was also swept to 1. OV (vs. SCE).
  • the anode current was not measured up to about 0.8 V (vs. SCE).
  • the corrosion potential of sample 5 is I could't evaluate it. Similar results were obtained for Sample 1 to Sample 4. The same result was obtained for Comparative Sample 1 (gold (pure gold)).
  • each sample has sufficiently high chemical stability as does comparative sample 1 (gold (pure gold)).
  • comparative sample 2 gold (pure gold)
  • the anode current increased at about ⁇ 0.3 V (vs. SCE), and this potential was recognized as the corrosion potential of copper.
  • Example 3 shows that the stent of the present invention is sufficiently high and has blood compatibility (antithrombogenicity). This is an example (blood compatibility (antithrombogenicity test)).
  • the platelet count is adjusted to 3.9 X 10 5 cells / 1 by mixing the appropriate amount of both, and 0.25 mol / l of salty calcium is added (to 2 ml of mixed solution) 0.1 7 ml of salted calcium was added to adjust the coagulation rate and used in the experiment.
  • a test piece (5 mm ⁇ 5 mm, thickness lmm) (see FIG. 5) was dropped on the test piece and stored in a 37 ° C. incubator for a predetermined time (5 minutes, 20 minutes). After a predetermined incubation time, wash with PBS (-), soak in dartalaldehyde and fix for 2 days, wash again with PBS (-), dry, and concentrate (50%, 70%, 90%) %, 100%), which was dehydrated sequentially with different alcohols, and gold deposited with a thickness of about 25 nm were observed by SEM to evaluate the amount of platelet adhesion.
  • Example 1 to sample 5 For comparison with each sample (sample 1 to sample 5), Ti-Ni superelastic alloy (comparative sample 1), 316L stainless steel (comparative sample 2), and biological Pure titanium (Comparative Sample 3) and Co—Cr alloy (Comparative Sample 4) used as alloys for the test were simultaneously subjected to the test.
  • Table 3 shows the results of SEM observation of the surface for each sample (Sample 1 to Sample 5) and each comparative sample (Comparative Sample 1 to Comparative Sample 5) after the test.
  • Sample 1 to Sample 3 have sufficiently high blood compatibility (antithrombogenicity).
  • Sample 4 and Sample 5 are not as good as Type 316 stainless steel (Comparative Sample 2)! / ⁇ , but the conventional Ti-Ni superelastic alloy (Comparative Sample 1) or Co-Cr alloy (Comparative Sample 4) ) And a sufficiently high blood compatibility (antithrombogenicity).
  • Type 316 stainless steel (Comparative Sample 2) has a sufficiently high blood compatibility (antithrombogenicity), but is poor in chemical stability.
  • a stent using the precious metal alloy of sample 1 to sample 3 but also in the case of a stent using the precious metal alloy of sample 4 or sample 5 Seems to be better.
  • Example 4 is an example (tensile test) to show that the stent of the present invention has a sufficiently high mechanical strength.
  • Table 4 shows the maximum tensile strength (UTS) and elongation at break ( ⁇ ) of each sample (Sample 1 to Sample 5).
  • the gold content (mol%) Xl in the noble metal alloy and the palladium content (mol%) X2 in the noble metal alloy are ⁇ 0. 79 ⁇ X1 / (X1 + X2) ⁇ 0.88 '' force
  • a noble metal alloy satisfying the following formula (3) is used, and in the stent according to the second embodiment, the gold content (mol%) XI in the noble metal alloy, Palladium content (mol%) X2 in the noble metal alloy is a noble metal alloy satisfying the formula (4) consisting of ⁇ 0.68 ⁇ XI / (X1 + X2) ⁇ 0.79 ''. Is not limited to this.
  • Gold content (mol%) Xl in noble metal alloy and palladium content (mol%) X2 in precious metal alloy and force “0.65 ⁇ X1 / (X1 + X2) ⁇ 0.95” force (1 ) can also provide a stent with higher blood compatibility (antithrombogenicity) than conventional stents, because the gold content is higher than that of conventional stents. Become.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Inorganic Chemistry (AREA)
  • Surgery (AREA)
  • Epidemiology (AREA)
  • Materials Engineering (AREA)
  • Mechanical Engineering (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne une endoprothèse vasculaire faite d'un alliage de métaux nobles contenant de l'or et du palladium, caractérisé en ce que l'alliage des métaux nobles satisfait la relation représentée par la formule suivante (1), dans laquelle X1 représente la teneur (% en mole) en or dans l'alliage de métaux nobles et X2 représente la teneur (% en mole) en palladium dans l'alliage des métaux nobles : 0,65 ≤ X1/(X1 + X2) ≤ 0,95 (1). L'endoprothèse vasculaire décrite ci-dessus a une teneur en or élevée par comparaison avec les endoprothèses vasculaires actuelles. Ainsi, il devient possible de fournir une endoprothèse vasculaire qui est supérieure en stabilité chimique et en compatibilité avec le sang (propriétés antithrombotiques) aux endoprothèses vasculaires actuelles.
PCT/JP2006/318142 2006-09-13 2006-09-13 Endoprothèse vasculaire Ceased WO2008032370A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2006/318142 WO2008032370A1 (fr) 2006-09-13 2006-09-13 Endoprothèse vasculaire

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Application Number Priority Date Filing Date Title
PCT/JP2006/318142 WO2008032370A1 (fr) 2006-09-13 2006-09-13 Endoprothèse vasculaire

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WO2008032370A1 true WO2008032370A1 (fr) 2008-03-20

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021050400A (ja) * 2019-09-26 2021-04-01 田中貴金属工業株式会社 医療用Ａｕ−Ｐｔ−Ｐｄ合金
WO2021060314A1 (fr) * 2019-09-26 2021-04-01 田中貴金属工業株式会社 Alliage au-pt-pd médical

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02503759A (ja) * 1988-04-07 1990-11-08 ヘレーウス　エーデルメタレ　ゲゼルシヤフト　ミツト　ベシユレンクテル　ハフツング 焼結された金属義歯部材を製造する方法
JP2004505651A (ja) * 1999-04-13 2004-02-26 エレファント　デンタル　ベー．フェー． 生物医学用の補助材または埋込材
JP2006043199A (ja) * 2004-08-05 2006-02-16 Homuzu Giken:Kk ステント及びその製造方法

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH02503759A (ja) * 1988-04-07 1990-11-08 ヘレーウス　エーデルメタレ　ゲゼルシヤフト　ミツト　ベシユレンクテル　ハフツング 焼結された金属義歯部材を製造する方法
JP2004505651A (ja) * 1999-04-13 2004-02-26 エレファント　デンタル　ベー．フェー． 生物医学用の補助材または埋込材
JP2006043199A (ja) * 2004-08-05 2006-02-16 Homuzu Giken:Kk ステント及びその製造方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
TANAKA KIKINZOKU KOGYO KABUSHIKI KAISHA: "Kikinzoku no Ohanashi, 2nd print", 1989, pages: 40 - 46, XP003021717 *

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021050400A (ja) * 2019-09-26 2021-04-01 田中貴金属工業株式会社 医療用Ａｕ−Ｐｔ−Ｐｄ合金
WO2021060314A1 (fr) * 2019-09-26 2021-04-01 田中貴金属工業株式会社 Alliage au-pt-pd médical
JP2021050401A (ja) * 2019-09-26 2021-04-01 田中貴金属工業株式会社 医療用Ａｕ−Ｐｔ−Ｐｄ合金
WO2021060313A1 (fr) * 2019-09-26 2021-04-01 田中貴金属工業株式会社 Alliage au–pt–pd médical
US11453931B2 (en) 2019-09-26 2022-09-27 Tanaka Kikinzoku Kogyo K.K. Medical Au-Pt-Pd alloy
US20230113633A1 (en) * 2019-09-26 2023-04-13 Tanaka Kikinzoku Kogyo K.K. MEDICAL Au-Pt-Pd ALLOY

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