WO2011084240A1 - Procédé pour améliorer les propriétés d'un composant d'un dispositif médical contenant un alliage de nickel - titane - chrome - Google Patents

Procédé pour améliorer les propriétés d'un composant d'un dispositif médical contenant un alliage de nickel - titane - chrome Download PDF

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WO2011084240A1
WO2011084240A1 PCT/US2010/056938 US2010056938W WO2011084240A1 WO 2011084240 A1 WO2011084240 A1 WO 2011084240A1 US 2010056938 W US2010056938 W US 2010056938W WO 2011084240 A1 WO2011084240 A1 WO 2011084240A1
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Prior art keywords
component
medical device
temperature
ksi
cold work
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PCT/US2010/056938
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English (en)
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James M. Carlson
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Cook Incorporated
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Priority to US13/516,351 priority Critical patent/US20120255657A1/en
Publication of WO2011084240A1 publication Critical patent/WO2011084240A1/fr

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C14/00—Alloys based on titanium
    • 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
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C19/00—Alloys based on nickel or cobalt
    • C22C19/03—Alloys based on nickel or cobalt based on nickel
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C19/00—Alloys based on nickel or cobalt
    • C22C19/03—Alloys based on nickel or cobalt based on nickel
    • C22C19/05—Alloys based on nickel or cobalt based on nickel with chromium
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/10—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of nickel or cobalt or alloys based thereon
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/16—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of other metals or alloys based thereon
    • C22F1/18—High-melting or refractory metals or alloys based thereon
    • 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
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/16—Materials with shape-memory or superelastic properties
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L2201/00—Properties
    • C08L2201/12—Shape memory

Definitions

  • the present disclosure is directed generally to processing methods for medical device components and more particularly to a method of improving the properties of a medical device component comprising a Ni-Ti-Cr alloy.
  • Nickel-titanium alloys are commonly used for the manufacture of endoluminal biomedical devices, such as self-expandable stents, stent grafts, embolic protection filters, and stone extraction baskets. These devices may exploit the superelastic or shape memory behavior of equiatomic or near- equiatomic nickel-titanium alloys.
  • Such alloys which are commonly referred to as Nitinol or Nitinol alloys, undergo a phase transformation between a lower temperature phase (martensite) and a higher temperature phase (austenite) that allows a previous shape or configuration to be "remembered” and recovered.
  • strain introduced into a Nitinol stent in the martensitic phase to achieve a compressed configuration may be substantially recovered upon completion of a reverse phase transformation to austenite, allowing the alloy to elastically spring back to an expanded configuration.
  • the strain recovery may be driven by the removal of an applied stress (superelastic effect) and/or by a change in temperature (shape memory effect).
  • strains of up to 8-10% may be recovered during the phase transformation.
  • a superelastic component may undergo a heat setting treatment during processing. During heat setting, the component is constrained in the desired configuration and heated for a certain time and temperature. During this process, a "memory" of the desired configuration is imparted to the alloy.
  • different heat setting treatments have been evaluated and general guidelines regarding heat setting conditions are known in the art.
  • stents employed in the superficial femoral artery an enhancement of the properties of conventional binary Nitinol alloys is desired.
  • SFA superficial femoral artery
  • an enhancement of the properties of conventional binary Nitinol alloys is desired.
  • the SFA may experience repetitive axial strains that can cause the artery to elongate or contract up to 10-12%. Stents placed in the SFA may thus be prone to fatigue failure.
  • a stent deployed in the SFA or other superficial arteries may be subjected to crushing loads due to the proximity of the artery to the surface of the skin.
  • a major challenge of treating the SFA is providing a stent having sufficient elasticity, crush resistance, and fatigue properties to withstand the strains of the arterial environment.
  • Ni-Ti-X alloys where X is another metallic alloying element, have been proposed for the purpose of improving the mechanical properties of binary Nitinol alloys.
  • changes in the procedure used to fabricate and heat set the binary alloy may be required.
  • a challenge is to formulate a processing regime for the desired Ni-Ti-X alloy so as to achieve the mechanical properties without sacrificing the superelastic behavior and characteristics.
  • a method of improving the superelastic and mechanical properties of a component of a medical device is set forth herein. Also described is a medical device including a superelastic component with improved properties. Both the method and the medical device are directed to a component including a Ni-Ti-Cr alloy.
  • the method of improving the properties of the medical device entails constraining the component, which comprises about 45-55 at.% Ni, about 45-55 at.% Ti, and about 0.3 at.% Cr, into a predetermined
  • the component also includes at least about 35% cold work. During the constraining, the component is heated at a temperature of between about 425°C and about 500°C for a time duration of between about 5 minutes and about 30 minutes. The superelastic and mechanical properties of the component are thereby improved.
  • the medical device includes a component comprising about 45-55 at.% Ni, about 45-55 at.% Ti, and about 0.3 at.% Cr, where the component has an upper plateau strength of at least about 75 ksi, a residual elongation of about 0.1 % or less, and an austenite finish temperature (A f ) of about 30°C or less.
  • Figure 1 is a plot of austenite finish temperature (A f ) as a function of heat setting temperature (deg C) for a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 2 is a plot of upper plateau strength, tensile strength and lower plateau strength (psi) as a function of heat setting temperature (deg C) for a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 3 is a plot of residual elongation (%) as a function of heat setting temperature (deg C) for a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 4 is a plot of uniform elongation (%) as a function of heat setting temperature (deg C) for a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 5 is a plot of austenite finish temperature (A f ) as a function of cold work (%) imparted to a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 6 is a plot of upper plateau strength, tensile strength and lower plateau strength (psi) as a function of cold work (%) imparted to a Ni-Ti- 0.25 at.% Cr wire specimen;
  • Figure 7 is a plot of residual elongation (%) as a function of cold work (%) imparted to a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 8 is a plot of uniform elongation (%) as a function of cold work (%) imparted to a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 9 is a plot of austenite finish temperature (A f ) as a function of heat setting time (min) for a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 10 is a plot of upper plateau strength, tensile strength and lower plateau strength (psi) as a function of heat setting time (min) for a Ni-Ti- 0.25 at.% Cr wire specimen;
  • Figure 1 1 is a plot of residual elongation (%) as a function of heat setting time (min) for a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 12 is a plot of uniform elongation (%) as a function of heat setting time (min) for a Ni-Ti-0.25 at.% Cr wire specimen;
  • Figure 13 is a plot of radial force per unit length of 7 Fr Ni-Ti-Cr alloy stents having the Zilver® geometry;
  • Figure 14 is a plot of radial force per unit length of 7 Fr Ni-Ti binary alloy stents having the Zilver® geometry.
  • Figure 15 is a plot overlaying the radial force per unit length for representative test articles of ternary and binary alloy stents.
  • Binary Nitinol alloy - an alloy including about 45-55 at.% Ni and about 45-55 at.% Ti and no additional alloying elements, with the exception of any incidental impurities.
  • Austenite finish temperature (A f ) the temperature at which, for a shape memory alloy having a higher temperature phase (austenite) and a lower temperature phase (martensite), a phase transformation to the austenitic phase is complete.
  • a f Austenite finish temperature
  • Percent (%) cold work a measurement of the amount of plastic deformation imparted to a component, where the amount is calculated as a percent reduction in a given dimension. For example, in wire and/or tube drawing, the percent cold work corresponds to the percent reduction in wire or tube cross-sectional area resulting from a drawing pass.
  • ASTM Standard F 2516 This property is an indicator of the radial force that may be obtained from an expandable stent in use in a body vessel.
  • Described here is a method of improving the superelastic and mechanical properties of a medical device component including a Ni-Ti-Cr alloy.
  • the method entails constraining the component, which contains about 45-55 at.% Ni, about 45-55 at.% Ti, and less than about 1 at.% Cr, into a predetermined configuration, such as a deployed configuration if the component is a stent or another endoluminal medical device.
  • the component also includes at least about 35% cold work. Once constrained, the component is heated at a temperature in the range of about 425°C to about 500°C for a time duration of from about 5 to about 30 minutes so as to improve the superelastic and mechanical properties of the component.
  • wire specimens drawn to a diameter of 0.01 inch and including either a low (-30%) or high (-45%) level of cold work underwent heat setting at temperatures ranging from 350°C to 550°C for time durations of 5 to 70 minutes.
  • the wire specimens were heated at 350, 400, 450, 500, or 550°C for 5, 20, 60, or 70 minutes followed by water quenching.
  • a total of 74 wire specimens having a gage length of 150 mm and an additional 13 specimens having a gage length of 102 mm underwent tensile testing at 37°C (body temperature) to simulate the conditions a medical device might experience in vivo.
  • a summary of the wire specimens tested, including the amount of cold work and the heat setting conditions employed for each specimen, is provided in Table 1 .
  • the tensile test data obtained in the preceding table may be analyzed according to the protocol set forth below, along with data from differential scanning calorimetry (DSC) experiments, in order to determine optimal processing conditions for the Ni-Ti-Cr wire specimens.
  • DSC differential scanning calorimetry
  • the results of the tensile tests and DSC experiments may be evaluated according to the following criteria and generally in the order indicated:
  • Figures 9-12 suggest that shorter heat setting time durations ⁇ e.g., 5-20 minutes compared to 60 minutes or more) may be associated with lower values of A f and higher strengths.
  • the Ni-Ti-Cr alloy specimen may be heat set at a temperature in the range of from about 425°C to about 500°C. As indicated, a temperature in the range of from about 450°C to about 475°C may be particularly effective.
  • the heat setting temperature preferably does not exceed 500°C, and is no lower than 425°C.
  • the heat setting may occur for a time duration of from about 5 min to about 30 min, or from about 5 min to about 20 min.
  • Ni-Ti-0.25 at.% Cr specimens having a higher level of cold work generally show better performance
  • a cold work level of at least about 35% is preferred, with the range of from about 35% to about 45% being particularly suitable for the Ni-Ti-0.25 at.% Cr wire specimens.
  • specimens may be cold worked up to 60% reduction in area provided that they have been properly annealed prior to drawing.
  • fracture of the cannula or wire is possible as the cross section becomes smaller if defects are present, such as large carbides, oxides, nitrides, drawing defects, pits, etc. Accordingly, a cold work level of between about 40% and about 45% is expected to be a maximum preferred range.
  • Ni-Ti-0.25 at.% Cr stents prepared from tubing including from 35%-45% cold work and processed using optimized heat setting conditions.
  • cold worked Ni-Ti-0.25 at.% Cr tubing was laser cut to have the Zilver® stent pattern, and the stents were heat set at 450°C for 15-30 minutes and electropolished.
  • Each stent was deployed from its delivery system and attached to an EnduraTEC ELF tester using suitable fixtures.
  • the gage length (distance between the mandrels on the tester) was set to 15 mm ⁇ 0.5 mm and the stent was subjected to time accelerated, displacement-controlled longitudinal fatigue that corresponded to the desired percent change in gage length.
  • testing was performed at 70 Hz in 37°C ⁇ 2°C water until "run-out" (equivalent of 10 years or 10 million cycles) was reached or until fractures were observed.
  • the temperature of the testing solution was measured at the beginning and end of each test at minimum.
  • Each stent was visually monitored for fractures in the gage section. In the event of a fracture, the approximate number of cycles at which fracture occurred and location of the fracture were recorded.
  • the axial endurance limit of two designs of 6 mm (nominal diameter) stents cut from Ni-Ti-Cr alloy tubing was determined.
  • the axial endurance limit is defined as the percent change in gage length at which six out of six test articles achieve run-out, whereas at least one test article out of four tested at higher percent changes in length (in increments of 1 %) exhibited fractures prior to reaching 10 million cycles.
  • test articles were placed in a low-friction, stainless steel Machine Solutions radial expansion force gage.
  • the temperature within the tester was maintained at 37°C ⁇ 2°C during testing.
  • Each test article was compressed from an initial, fully expanded diameter to a final diameter of 5 mm at a rate of 0.2 mm/s.
  • the test article was then allowed to expand back to the initial diameter at the same rate.
  • the compression and expansion were repeated for three cycles. Hoop force, diameter, and time were captured via the Machine Solutions software. Radial force was calculated from the hoop force at 5, 6, 7, 8, and 9 mm during the third cycle and recorded. These diameters are in the range of expected in vivo conditions.
  • the third compression and expansion cycle of the test was used for data analysis to ensure that the stent equilibrated to the compression and expansion cycles.
  • Figure 13 shows the radial force per unit length of the Ni-Ti-Cr alloy stents
  • Figure 14 shows the radial force per unit length of the binary Nitinol alloy stents
  • Figure 15 provides an overlay of the radial force per unit length for representative Ni-Ti- Cr alloy and binary Nitinol alloy test articles.
  • a t-test was performed comparing the radial force per unit length of the Ni-Ti-Cr alloy stents versus the binary alloy stents.
  • the t-test showed that the radial force per unit length of the ternary alloy stents was significantly higher than that of the binary alloy stents during loading and unloading at each diameter (p ⁇ 0.05 in each case).
  • a 95% confidence interval for the difference in means was constructed. Margins of superiority for the increase in radial force per unit length for the Ni-Ti-Cr alloy stents were subsequently calculated from the difference in means and are shown in Table 10.

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Abstract

L'invention concerne un procédé pour améliorer les propriétés d'un composant d'un dispositif médical qui entraîne le maintien du composant, qui contient d'environ 45 % atomiques à 55 % atomiques de Ni, d'environ 45 % atomiques à 55 % atomiques de Ti, et environ 0,3 % atomiques de Cr, dans une configuration prédéterminée. Le composant contient également au moins environ 35 % de déformation à froid. Le composant est chauffé pendant le maintien à une température qui est comprise entre environ 425°C et environ 500°C pendant une période de temps qui est comprise entre environ 5 minutes et environ 30 minutes, améliorant ainsi les propriétés super-élastiques et mécaniques du composant. Un dispositif médical comprend un composant super-élastique à utiliser dans un récipient de corps qui contient d'environ 45 % atomiques à 55 % atomiques de Ni, d'environ 45 % atomiques à 55 % atomiques de Ti, et environ 0,3 % atomique de Cr, où le composant présente une résistance du plateau supérieur d'au moins environ 75 ksi, un allongement résiduel d'environ 0,1 %, ou moins, et une température de finition de l'austénite (Af) d'environ 30°C, ou moins.
PCT/US2010/056938 2009-12-17 2010-11-17 Procédé pour améliorer les propriétés d'un composant d'un dispositif médical contenant un alliage de nickel - titane - chrome WO2011084240A1 (fr)

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Application Number Priority Date Filing Date Title
US13/516,351 US20120255657A1 (en) 2009-12-17 2010-11-17 Method of improving the properties of a component of a medical device comprising a nickel-titanium-chromium alloy

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US28749909P 2009-12-17 2009-12-17
US61/287,499 2009-12-17

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US10918773B2 (en) * 2018-03-26 2021-02-16 Tci Llc Collapsible and self-expanding cannula for a percutaneous heart pump and method of manufacturing

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62211339A (ja) * 1986-03-11 1987-09-17 Keijiyou Kioku Gokin Gijutsu Kenkyu Kumiai Ｎｉ−Ｔｉ−Ｃｒ形状記憶合金
WO1998039048A2 (fr) * 1997-03-06 1998-09-11 Percusurge, Inc. Fils metalliques medicaux creux et procede de fabrication
JP2001164348A (ja) * 1999-09-27 2001-06-19 Furukawa Techno Material Co Ltd 医療用ガイドワイヤに用いられる広ひずみ範囲高弾性Ｎｉ−Ｔｉ系合金ワイヤの製造方法、および前記製造方法により製造された医療用ガイドワイヤに用いられる広ひずみ範囲高弾性Ｎｉ−Ｔｉ系合金ワイヤ
US6371463B1 (en) * 2000-04-21 2002-04-16 Dpd, Inc. Constant-force pseudoelastic springs and applications thereof
JP2003043427A (ja) * 2001-08-03 2003-02-13 Nec Tokin Corp 眼鏡フレーム及びその製造方法
JP2003089834A (ja) * 2001-09-19 2003-03-28 Furukawa Electric Co Ltd:The 高剛性型の可逆変形を有するＮｉ−Ｔｉ系合金
JP2005131358A (ja) * 2003-06-16 2005-05-26 Furukawa Techno Material Co Ltd Ｔｉ−Ｎｉ系超弾性合金線材

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS62211339A (ja) * 1986-03-11 1987-09-17 Keijiyou Kioku Gokin Gijutsu Kenkyu Kumiai Ｎｉ−Ｔｉ−Ｃｒ形状記憶合金
WO1998039048A2 (fr) * 1997-03-06 1998-09-11 Percusurge, Inc. Fils metalliques medicaux creux et procede de fabrication
JP2001164348A (ja) * 1999-09-27 2001-06-19 Furukawa Techno Material Co Ltd 医療用ガイドワイヤに用いられる広ひずみ範囲高弾性Ｎｉ−Ｔｉ系合金ワイヤの製造方法、および前記製造方法により製造された医療用ガイドワイヤに用いられる広ひずみ範囲高弾性Ｎｉ−Ｔｉ系合金ワイヤ
US6371463B1 (en) * 2000-04-21 2002-04-16 Dpd, Inc. Constant-force pseudoelastic springs and applications thereof
JP2003043427A (ja) * 2001-08-03 2003-02-13 Nec Tokin Corp 眼鏡フレーム及びその製造方法
JP2003089834A (ja) * 2001-09-19 2003-03-28 Furukawa Electric Co Ltd:The 高剛性型の可逆変形を有するＮｉ−Ｔｉ系合金
JP2005131358A (ja) * 2003-06-16 2005-05-26 Furukawa Techno Material Co Ltd Ｔｉ−Ｎｉ系超弾性合金線材

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