WO1995019800A2 - Fil de guidage avec partie distale superelastique - Google Patents

Fil de guidage avec partie distale superelastique Download PDF

Info

Publication number
WO1995019800A2
WO1995019800A2 PCT/US1994/000468 US9400468W WO9519800A2 WO 1995019800 A2 WO1995019800 A2 WO 1995019800A2 US 9400468 W US9400468 W US 9400468W WO 9519800 A2 WO9519800 A2 WO 9519800A2
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
distal
proximal
distal portion
austenite
Prior art date
Application number
PCT/US1994/000468
Other languages
English (en)
Other versions
WO1995019800A3 (fr
Inventor
Robert M. Abrams
Randy S. Chan
Janet W. Burpee
Original Assignee
Advanced Cardiovascular Systems, 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
Priority to US07/994,679 priority Critical patent/US5341818A/en
Priority claimed from US07/994,679 external-priority patent/US5341818A/en
Application filed by Advanced Cardiovascular Systems, Inc. filed Critical Advanced Cardiovascular Systems, Inc.
Priority to EP94907814A priority patent/EP0739221B1/fr
Priority to PCT/US1994/000468 priority patent/WO1995019800A2/fr
Priority to DE69433668T priority patent/DE69433668T2/de
Priority to JP51952195A priority patent/JP3725900B2/ja
Publication of WO1995019800A2 publication Critical patent/WO1995019800A2/fr
Publication of WO1995019800A3 publication Critical patent/WO1995019800A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C30/00—Alloys containing less than 50% by weight of each constituent
    • 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
    • C22F1/006—Resulting in heat recoverable alloys with a memory effect
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • A61M2025/09141—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque made of shape memory alloys which take a particular shape at a certain temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0266—Shape memory materials

Definitions

  • This invention relates to the field of medical devices, and more particularly to guiding means such as a guidewire for advancing a catheter within a body lumen in a procedure such as percutaneous transluminal coronary angioplasty (PTCA).
  • PTCA percutaneous transluminal coronary angioplasty
  • a guiding catheter having a preformed distal tip is percutaneously introduced into the cardiovascular system of a patient in a conventional Seldinger technique and advanced therein until the distal tip of the guiding catheter is seated in the ostium of a desired coronary artery.
  • a guidewire is positioned within an inner lumen of a dilatation catheter and then both are advanced through the guiding catheter to the distal end thereof. The guidewire is first advanced out of the distal end of the guiding catheter into the patient's coronary
  • the dilatation catheter having an inflatable balloon on the distal portion thereof is advanced into the patient's coronary anatomy over the previously introduced guidewire until the balloon of the dilatation catheter is properly positioned across the lesion.
  • the balloon is inflated to a predetermined size with radiopaque liquid at relatively high pressures (e.g. greater than 4 atmospheres) to compress the arteriosclerotic plaque of the lesion against the inside of the artery wall and to otherwise expand the inner lumen of the artery.
  • the balloon is then deflated so that blood flow is resumed through the dilated artery and the di ⁇ latation catheter can be removed therefrom.
  • Conventional guidewires for angioplasty and other vascular procedures usually comprise an elongated core member with one or more tapered sections near the distal end thereof and a flexible body such as a helical coil disposed about the distal portion of the core member.
  • a shapable member which may be the distal extremity of the core member or a separate shaping ribbon which is secured to the distal extremity of the core member extends through the flexible body and is secured to a rounded plug at the distal end of the flexible body.
  • Torquing means are provided on the proximal end of the core member to rotate, and thereby steer, the guidewire while it is being advanced through a patient's vascular system.
  • Steerable dilatation catheters with fixed, built-in guiding members are frequently used because they have lower deflated profiles than conventional over-the-wire dilatation catheters and a lower profile allows the catheter to cross tighter lesions and to be advanced much deeper into a patient's coronary anatomy.
  • guidewires and other guiding mem ⁇ bers whether they be solid wire or tubular members, are solid wire or tubular members, are required to have sufficient column strength to be pushed through a patient's vascular system or other body lumen without kinking. However, they must also be flexible enough to avoid damaging the blood vessel or other body lumen through which they are advanced. Efforts have been made to improve both the strength and flexibility of guidewires to make them more suitable for their intended uses, but these two properties are for the most part diametrically opposed to one another in that an increase in one usually involves a decrease in the other.
  • the prior art makes reference to the use of alloys such as Nitinol (Ni-Ti alloy) which have shape memory and/or superelastic characteristics in medical devices which are designed to be inserted into a patient's body.
  • the shape memory characteristics allow the devices to be deformed to facilitate their insertion into a body lumen or cavity and then be heated within the body so that the device returns to ts original shape.
  • Superelastic characteristics on the other hand generally allow the metal to be deformed and restrained in the deformed condition to facilitate the insertion of the medical device containing the metal into a patient's body, with such deformation causing the phase transformation. Once within the body lumen the restraint on the superelastic member can be removed, thereby reducing the stress therein so that the superelastic member can return to its original undeformed shape by the transformation back to the original phase.
  • Alloys having shape memory/superelastic characteristics generally have at least two phases, a martensite phase, which has a relatively low tensile strength and which is stable at relatively low temperatures, and an austenite phase, which has a relatively high tensile strength and which is stable at temperatures higher than the martensite phase.
  • Shape memory characteristics are imparted to the alloy by heating the metal at a temperature above which the transformation from the martensite phase to the austenite phase is complete, i.e. a temperature above which the austenite phase is stable.
  • the shape of the metal during this heat treatment is the shape "remembered".
  • the heat treated metal is cooled to a temperature at which the martensite phase is stable, causing the austenite phase to transform to the martensite phase.
  • the metal in the martensite phase is then plastically deformed, e.g. to facilitate the entry thereof into a patient's body. Subsequent heating of the deformed martensite phase to a temperature above the martensite to austenite transformation temperature causes the deformed martensite phase to transform to the austenite phase and during this phase transformation the metal reverts back to its original shape.
  • the specimen When stress is applied to a specimen of a metal such as Nitinol exhibiting superelastic characteristics at a temperature at or above which the transformation of martensite phase to the austenite phase is complete, the specimen deforms elastically until it reaches a particular stress level where the alloy then undergoes a stress-induced phase transformation from the austenite phase to the martensite phase. As the phase transformation proceeds, the alloy undergoes significant increases in strain but with little or no corresponding increases in stress. The strain increases while the stress remains essentially constant until the transformation of the austenite phase to the martensite phase is complete. Thereafter, further increase in stress are necessary to cause further deformation. The martensitic metal first yields elastically upon the application of additional stress and then plastically with permanent residual deformation.
  • a metal such as Nitinol exhibiting superelastic characteristics
  • the martensitic specimen will elastically recover and transform back to the austenite phase.
  • the reduction in stress first causes a decrease in strain.
  • stress reduction reaches the level at which the martensite phase transforms back into the austenite phase
  • the stress level in the specimen will remain essentially constant (but substantially less than the constant stress level at which the austenite transforms to the martensite) until the transformation back to the austenite phase is complete, i.e. there is significant recovery in strain with only negligible corresponding stress reduction.
  • further stress reduction results in elastic strain reduction. This ability to incur significant strain at relatively constant stress upon the application of a load and to recover from the deformation upon the removal of the load is commonly referred to as superelasticity or pseudoelasticity.
  • the Sakamoto et al patent discloses the use of a nickel- titanium superelastic alloy in an intravascular guidewire which could be processed to develop relatively high yield strength levels.
  • a nickel- titanium superelastic alloy in an intravascular guidewire which could be processed to develop relatively high yield strength levels.
  • it did not have a very extensive stress-induced strain range in which the austenite transforms to
  • the present invention is directed to improve guidewires or guiding members, wherein the distal portion is provided with superelastic characteristics resulting from the stress-induced transformation of austenite to martensite and wherein the proximal portion is provided with high strength elastic materials.
  • the guidewire or guiding member of the invention has a high strength proximal section with a high strength distal section with superelastic properties and a connector element between the proximal and distal sections which has superelastic properties to provide a smooth transition between the proximal and the distal sections.
  • the guidewire or guiding member has a solid core distal section formed of superelastic materials such as NiTi type alloys and the connector is a hollow tubular shaped member which has a inner passageway adapted to receive the proximal end of the solid core distal section.
  • the superelastic distal core member and the hollow connector of the invention exhibit stress-induced phase transformation at body temperature (about 37 ° C) at a stress level well above about 50 ksi,
  • the complete stress-induced transformation of the austenite phase to the martensite phase causes a strain in the specimen of at least about 4%, preferably over 5%.
  • the region of phase transformation resulting from stress preferably begins when the specimen has been strained about 2 to 3% at the onset of the phase change from austenite to martensite and extends to about 7 to about 9% strain at the completion of the phase change.
  • the stress and strain referred to herein is measured by tensile testing.
  • the stress-strain relationship determined by applying a bending moment to a cantilevered specimen is slightly different from the relationship determined by tensile testing because the stresses which occur in the specimen during bending are not as uniform as they are in tensile testing. There is considerably less change in stress during the phase transformation than either before or after the stress-induced transformation. The stress level is relatively constant within the transformation period.
  • the portions of the guiding member having superelastic properties is preferably formed from an alloy consisting essentially of about 30 to about 52% titanium and the balance nickel and up to 10% of one or more additional alloying elements.
  • Such other alloying elements may be selected from the group consisting of up to 3 % each of iron, cobalt, platinum, palladium and chromium and up to about 10% copper and vanadium.
  • all references to percent composition are atomic percent unless otherwise noted.
  • elongated solid rod or tubular stock of the preferred alloy material is first cold worked, preferably by drawing, to effect a size reduction of about 30% to about 70% in the transverse cross section thereof.
  • the cold worked material may then be given a memory imparting heat treatment at a temperature of about 350 ° to about 600 ° C for about 0.5 to about 60 min ⁇ utes, while maintaining a longitudinal stress on the elongated portion equal to about 5% to about 50%, preferably about 10% to about 30%, of the yield stress of the material (as measured at room temperature).
  • This thermomechanical processing imparts a straight "memory" to the superelastic portion and provides a relatively uniform residual stress in the material.
  • Another method involves mechanically straightening the wire after the cold work and then heat treating the wire at temperatures between about 300 ° and about 450 ° C, preferably about 330 ° to about 400 ° C.
  • the latter treatment provides substantially higher tensile properties.
  • the cold worked and heat treated alloy material has an austenite finish transformation temperature less than body temperature and generally about -10 ° C.to about 30 ° C.
  • it is preferred to fully anneal the solid rod or tubular stock prior to cold work so that the material will always have the same metallurgical structure at the start of the cold working and so that it will have adequate ductility for subsequent cold working. It will be appreciated by those skilled in the art that means of cold working the metal other than drawing, such as rolling or swaging, can be employed.
  • the constant yield stress levels for tubular products have been found to be slightly lower than the levels for solid products.
  • superelastic wire material of the invention will have a constant stress level usually above about 70 ksi, preferably above about 90 ksi, whereas, superelastic tubing material will have a constant stress level of above 50 ksi, preferable above about 70 ksi.
  • the ultimate tensile strength of both forms of the material is well above 200 ksi with an ultimate elongation at failure of about 15%.
  • the elongated superelastic members of the invention exhibit stress-induced austenite-to-martensite phase transformation over a broad region of strain at a very high, relatively constant stress levels.
  • a guiding member having a distal portion formed of this material is very flexible, it can be advanced through very tortuous passageways such as a patient's coronary vasculature with little risk that the superelastic portion of the guiding member will develop a permanent set and at the same time it will effectively transmit the torque applied thereto without causing the guiding member to whip.
  • the high strength proximal portion of the guidewire or guiding member provides excellent pushability and torquability to the guidewire or guiding member.
  • FIG. 1 is an elevational view of a guidewire which embodies features of the invention.
  • FIG. 2 is a schematic, graphical illustration of the stress-strain relationship of superelastic material.
  • FIG. 1 illustrates a guidewire 10 embodying features of the invention that is adapted to be inserted into a patient's body lumen, such as an artery.
  • the guidewire 10 comprises an elongated, relatively high strength proximal portion 11, a relatively short distal portion 12 which is formed substantially of superelastic alloy material and a connector element 13 which is formed substantially of superelastic alloy material and which connects the proximal end of the distal portion 12 to the distal end of the proximal portion 11 into a torque transmitting relationship.
  • the distal portion 12 has at least one tapered section 14 which becomes smaller in the distal direction.
  • the connector element 13 is a hollow tubular shaped element having an inner lumen extending therein which is adapted to receive the proximal end 15 of the distal portion 12 and the distal end 16 of the proximal portion 11.
  • the ends 15 and 16 may be press fit into the connector element or they may be secured therein by crimping or swaging the connector or by means such as a suitable adhesive or by welding, brazing or soldering.
  • a helical coil 17 is disposed about the distal portion 12 and has a rounded plug 18 on the distal end thereof.
  • the coil 17 is secured to the distal portion 12 at proximal location 20 and at intermediate location 21 by a suitable solder.
  • a shaping ribbon 22 is secured by its proximal end to the distal portion 12 at the same location 21 by the solder and by the distal end thereof to the rounded plug 18 which is usually formed by soldering or welding the distal end of the coil 17 to the distal tip of the shaping ribbon 22.
  • the most distal section 24 of the helical coil 17 is made of radiopaque metal such as platinum or platinum-nickel alloys to facilitate the observation thereof while it is disposed within a patient's body. The most distal section 24 should be stretched about 10 to about 30%.
  • the most distal part 25 of the distal portion 12 is flattened into a rectangular section and preferably provided with a rounded tip 26, e.g. solder to prevent the passage of the most distal part through the spacing between the stretched distal section 24 of the helical coil 17.
  • the exposed portion of the elongated proximal portion 11 should be provided with a coating 27 of lubricous material such as polytetrafluoroethylene (sold under the trademark Teflon by du Pont, de Nemours & Co.) or other suitable lubricous coatings such as the polysiloxane coatings disclosed in co-pending application Serial No. 559,373, filed July 24, 1990 which is hereby incorporated by reference.
  • the elongated proximal portion 11 of the guidewire 10 is generally about 130 to about 140 cm in length with an outer diameter of about 0.006 to 0.018 inch for coronary use. Larger diameter guidewires may be employed in peripheral arteries and other body lumens.
  • the lengths of the smaller diameter and tapered sections can range from about 2 to about 20 cm, depending upon the stiffness or flexibility desired in the final product.
  • the helical coil 17 is about 20 to about 45 cm in length, has an outer diameter about the same size as the diameter of the elongated
  • proximal portion 11 is made from wire about 0.002 to 0.003 inch in diameter.
  • the shaping ribbon 22 and the flattened distal section 26 of distal portion 12 have rectangular transverse cross-sections which usually have dimensions of about 0.001 by 0.003 inch.
  • the superelastic members of the invention i.e. the distal portion 12 and the connector 13, is preferably made of an alloy material consisting essentially of about 30 to about 52 % titanium and the balance nickel and up to 10% of one or more other alloying elements.
  • the other alloying elements may be selected from the group consisting of iron, cobalt, vanadium, platinum, palladium and copper.
  • the alloy can contain up to about 10% copper and vanadium and up to 3% of the other alloying elements.
  • the addition of nickel above the equiatomic amounts with titanium and the other identified alloying elements increase the stress levels at which the stress-induced austenite-to-martensite transformation occurs and ensure that the temperature at which the martensite phase transforms to the austenite phase is well below human body temperature so that austenite is the only stable phase at body temperature.
  • the excess nickel and additional alloying elements also help to provide an expanded strain range at very high stresses when the stress induced transformation of the austenite phase to the martensite phase occurs.
  • a presently preferred method for making the final configuration of the superelastic portions of the guiding member is to cold work, preferably by drawing, a rod or tubular member having a composition according to the relative proportions described above and then heat treating the cold worked product while it is under stress to impart a shape memory thereto.
  • Typical initial transverse dimensions of the rod or the tubular member are about 0.045 inch and about 0.25 inch respectively.
  • a small diameter ingot e.g. 0.25 to about 1.5 inch in diameter and 5 to about 30 inches in length, may be formed into a hollow tube by extruding or by machining a longitudinal center hole therethrough and grinding the outer surface thereof smooth.
  • it is preferably annealed at a temperature of about
  • the stressed relieved stock is cold worked by drawing to effect a reduction in the cross sectional area thereof of about 30 to about 70%.
  • the metal is drawn through one or more dies of appropriate inner diameter with a reduction per pass of about 10 to 50%.
  • Other forms of cold working can be employed such as swaging
  • the drawn wire or hollow tubular product is heat treated at a temperature between about 350 ° and about 600 ° C for about 0.5 to about 60 minutes.
  • the drawn wire or hollow tubualr product is simultaneously subjected to a longitudinal stress between about 5% and about 50%, preferably about 10% to about 30% of the tensile strength of the material (as measured at room temperature) in order to impart a straight "memory" to the metal and to ensure that any residual stresses therein are uniform.
  • This memory imparting heat treatment also fixes the austenite-martensite transformation temperature for the cold worked metal.
  • An alternate method for imparting a straight memory to the cold worked material includes mechanically straightening the wire or tube and then subjecting the straightened wire to a memory imparting heat treatment at a temperature of about 300 ° to about 450 ° C, preferably about 330 ° to about 400 ° C.
  • the latter treatment provides substantially improved tensile properties, but it is not very effective on materials which have been cold worked above 55%, particularly above 60%. Materials produced in this manner exhibit stress-induced austenite to martensite phase transformation at very high levels of stress but the stress during the phase transformation is not nearly as constant as the previously discussed method.
  • Conventional mechanical straightening means can be used such as subjecting the material to sufficient longitudinal stress to straighten it.
  • Fig. 2 illustrates an idealized stress-strain relationship of an alloy specimen having superelastic properties as would be exhibited upon tensile testing of the specimen.
  • the line from point A to point B thereon represents the elastic deformation of the specimen.
  • the strain or deformation is no longer proportional to the applied stress and it is in the region between point B and point C that the stress-induced transformation of the austenite phase to the martensite phase begins to occur.
  • the material enters a region of relatively constant stress with significant deformation or strain. It is in this region that the transformation from austenite to martensite occurs.
  • the transformation to the martensite phase due to the application of tensile stress to the specimen is substantially complete. Beyond point D the martensite phase begins to deform, elastically at first, but, beyond point E, the deformation is plastic or permanent.
  • the distal end of the guidewire When the distal end of the guidewire engages the wall of a body lumen such as a blood vessel, it will superelastically deform as the austenite transforms to martensite.
  • the stress is reduced or eliminated from within the superelastic portion of the guidewire and it recovers to its original shape, i.e. the shape "remembered” which is preferably straight.
  • the straight "memory" in conjunction with little or no nonuniform residual longitudinal stresses within the guidewire prevent whipping of the guidewire when it is torqued from the proximal end thereof.
  • due to the very high level of stress needed to transform the austenite phase to the martensite phase there is little chance for per ⁇ manent deformation of the guidewire or the guiding member when it is advanced through a patient's artery.
  • the tubular connector formed of superelastic alloy material provides a smooth transition between the high strength proximal portion and the relatively short distal section and retains a torque transmitting relationship between these two portions.
  • the present invention provides guidewires which have superelastic characteristics to facilitate the advancing thereof in a body lumen.
  • the guiding members exhibit extensive, recoverable strain resulting from stress induced phase transformation of austenite to martensite at exceptionally high stress levels which greatly minimizes the risk of damage to arteries during the advancement therein.
  • Nitinol hypotubing from which the connector is formed generally may have an outer diameter from about 0.006 inch to about 0.02 inch with wall thicknesses of about 0.001 to about 0.004 inch.
  • a presently preferred superelastic hypotubing for the connecting member has an outer diameter of about 0.014 inch and a wall thickness of about 0.002 inch.
  • Superelastic NiTi alloys such as those described herein, are very difficult to solder due to the formation of a tenacious, naturally occurring oxide coating which prevents the molten solder from wetting the surface of the alloy in a manner necessary to develop a sound, essentially oxide free, soldered joint. It has been found that by first treating the surface of the refractory superelastic alloy with molten alkali metal hydroxide, e.g. sodium, potassium, lithium or mixtures thereof to form a nascent alloy surface and then pretinning with a suitable solder such as a gold-tin solder without contacting air, that the superelastic piece can be readily soldered in a conventional manner.
  • a presently preferred alkali metal hydroxide is a mixture of about 59% K and about 41% Na.
  • the solder may contain from about 60 to about 85% gold and the balance tin, with the presently preferred solder containing about 80% gold and about
  • a multilayered bath is provided with an upper layer of molten alkali metal hydroxide and a lower layer of molten gold-tin solder.
  • the part of the superelastic distal portion, which is to be soldered, is thrust into the multilayered bath through the upper surface of the molten alkali metal hydroxide which removes the oxide coating, leaving a nascent metal alloy surface, and then into the molten solder which wets the nascent metal surface.
  • the solder solidifies upon removal from the molten solder into a thin coating on the metal alloy surface, the underlying alloy surface is protected from an oxygen-containing atmosphere.
  • any of the alkali metal hydroxide on the surface of the solder can be easily removed with water without detrimentally affecting either the pretinned layer or the underlying alloy surface.
  • the superelastic member is then ready for conventional soldering.
  • the procedure may be employed to prepare other metal alloys having significant titanium levels for soldering.
  • the high strength proximal portion of the guidewire generally is significantly stronger, i.e. higher ultimate tensile strength, than the superelastic distal portion.
  • Suitable high strength materials include 304 stainless steel which is a conventional material in guidewire construction.

Abstract

Un fil de guidage amélioré permettant de faire avancer un cathéter dans un lumen d'un corps possède une partie proximale de grande résistance, une partie distale en alliage superélastique et un connecteur en alliage superélastique afin de transmettre le couple de l'extrémité distale de la partie proximale à l'extrémité proximale de la partie distale. Les éléments en alliage superélastique subissent de préférence un traitement à froid puis un traitement à chaud à une température bien supérieure à la température de transformation de l'austénite-en-martensite, tout en étant soumis à des contraintes longitudinales égales à environ 5-50 % de la limite de contrainte à température ambiante afin de conférer au métal une 'mémoire' droite. L'élément de guidage utilisant ce matériau amélioré présente une transformation de phase austénite-en-martensite induite par contrainte à une limite élastique apparente constante exceptionnellement élevée d'au moins 70 ksi pour des éléments pleins et d'au moins 50 ksi pour des éléments tubulaires avec une grande déformation récupérable d'au moins 4 % environ pendant la transformation de phase.
PCT/US1994/000468 1992-12-22 1994-01-14 Fil de guidage avec partie distale superelastique WO1995019800A2 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
US07/994,679 US5341818A (en) 1992-12-22 1992-12-22 Guidewire with superelastic distal portion
EP94907814A EP0739221B1 (fr) 1994-01-14 1994-01-14 Fil de guidage avec partie distale superelastique
PCT/US1994/000468 WO1995019800A2 (fr) 1992-12-22 1994-01-14 Fil de guidage avec partie distale superelastique
DE69433668T DE69433668T2 (de) 1994-01-14 1994-01-14 Führungsdraht mit einem superelastischen distalen teilstück
JP51952195A JP3725900B2 (ja) 1994-01-14 1994-01-14 超弾性遠位部分を有するガイドワイヤ

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US07/994,679 US5341818A (en) 1992-12-22 1992-12-22 Guidewire with superelastic distal portion
PCT/US1994/000468 WO1995019800A2 (fr) 1992-12-22 1994-01-14 Fil de guidage avec partie distale superelastique

Publications (2)

Publication Number Publication Date
WO1995019800A2 true WO1995019800A2 (fr) 1995-07-27
WO1995019800A3 WO1995019800A3 (fr) 1995-09-08

Family

ID=26788161

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/000468 WO1995019800A2 (fr) 1992-12-22 1994-01-14 Fil de guidage avec partie distale superelastique

Country Status (1)

Country Link
WO (1) WO1995019800A2 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002094334A1 (fr) * 2001-05-21 2002-11-28 Medtronic, Inc. Dispositif medical allonge malleable
WO2008098191A2 (fr) * 2007-02-08 2008-08-14 C. R. Bard, Inc. Dispositif médical à mémoire de forme et ses procédés d'utilisation
EP2039378A2 (fr) * 2000-12-27 2009-03-25 Abbott Cardiovascular Systems Inc. Alliages de nitinol radiopaque pour dispositifs médicaux
US8222566B2 (en) 2003-02-26 2012-07-17 Boston Scientific Scimed, Inc. Elongated intracorporal medical device
US8487210B2 (en) 2010-06-11 2013-07-16 W. C. Hereaus GmbH Joined dissimilar materials and method
US8569625B2 (en) 2009-12-22 2013-10-29 W. C. Heraeus Gmbh Joined dissimilar materials

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2738294A (en) * 1951-09-13 1956-03-13 Diamond Alkali Co Salt bath system and method for treating metals
US2768271A (en) * 1953-10-22 1956-10-23 North American Aviation Inc Titanium heliarc brazing process
WO1989010088A1 (fr) * 1988-04-18 1989-11-02 Target Therapeutics Fil de guidage de catheter
WO1990013329A1 (fr) * 1989-05-03 1990-11-15 Progressive Angioplasty Systems, Inc. Catheter ayant un fil de guidage a sensibilite elevee
WO1991015152A1 (fr) * 1990-04-10 1991-10-17 Boston Scientific Corporation Fil de guidage elastique de grande elongation
EP0480427A1 (fr) * 1990-10-12 1992-04-15 Nippon Seisen Co., Ltd. Fil de guidage pour un cathéter
EP0491349A2 (fr) * 1990-12-18 1992-06-24 Advanced Cardiovascular Systems, Inc. Membre guide superélastique
EP0515078A2 (fr) * 1991-05-21 1992-11-25 Cook Incorporated Soudage d'alliages nickel-titane
EP0550258A1 (fr) * 1992-01-03 1993-07-07 Cook Incorporated Fil de guidage superélastique de faible diamètre
EP0569166A1 (fr) * 1992-05-01 1993-11-10 AT&T Corp. Soudure or-étain pour applications à auto-alignement

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2738294A (en) * 1951-09-13 1956-03-13 Diamond Alkali Co Salt bath system and method for treating metals
US2768271A (en) * 1953-10-22 1956-10-23 North American Aviation Inc Titanium heliarc brazing process
WO1989010088A1 (fr) * 1988-04-18 1989-11-02 Target Therapeutics Fil de guidage de catheter
WO1990013329A1 (fr) * 1989-05-03 1990-11-15 Progressive Angioplasty Systems, Inc. Catheter ayant un fil de guidage a sensibilite elevee
WO1991015152A1 (fr) * 1990-04-10 1991-10-17 Boston Scientific Corporation Fil de guidage elastique de grande elongation
EP0480427A1 (fr) * 1990-10-12 1992-04-15 Nippon Seisen Co., Ltd. Fil de guidage pour un cathéter
EP0491349A2 (fr) * 1990-12-18 1992-06-24 Advanced Cardiovascular Systems, Inc. Membre guide superélastique
EP0515078A2 (fr) * 1991-05-21 1992-11-25 Cook Incorporated Soudage d'alliages nickel-titane
EP0550258A1 (fr) * 1992-01-03 1993-07-07 Cook Incorporated Fil de guidage superélastique de faible diamètre
EP0569166A1 (fr) * 1992-05-01 1993-11-10 AT&T Corp. Soudure or-étain pour applications à auto-alignement

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2039378A2 (fr) * 2000-12-27 2009-03-25 Abbott Cardiovascular Systems Inc. Alliages de nitinol radiopaque pour dispositifs médicaux
EP2039378A3 (fr) * 2000-12-27 2014-07-09 Abbott Cardiovascular Systems Inc. Alliages de nitinol radiopaque pour dispositifs médicaux
WO2002094334A1 (fr) * 2001-05-21 2002-11-28 Medtronic, Inc. Dispositif medical allonge malleable
US8222566B2 (en) 2003-02-26 2012-07-17 Boston Scientific Scimed, Inc. Elongated intracorporal medical device
WO2008098191A2 (fr) * 2007-02-08 2008-08-14 C. R. Bard, Inc. Dispositif médical à mémoire de forme et ses procédés d'utilisation
WO2008098191A3 (fr) * 2007-02-08 2008-11-27 Bard Inc C R Dispositif médical à mémoire de forme et ses procédés d'utilisation
US8758268B2 (en) 2007-02-08 2014-06-24 C. R. Bard, Inc. Shape memory medical device and methods of use
US10967153B2 (en) 2007-02-08 2021-04-06 C. R. Bard, Inc. Shape memory medical device and methods of use
US8569625B2 (en) 2009-12-22 2013-10-29 W. C. Heraeus Gmbh Joined dissimilar materials
US8835799B2 (en) 2009-12-22 2014-09-16 Heraeus Precious Metals Gmbh & Co. Kg Method of joining dissimilar materials
US8487210B2 (en) 2010-06-11 2013-07-16 W. C. Hereaus GmbH Joined dissimilar materials and method

Also Published As

Publication number Publication date
WO1995019800A3 (fr) 1995-09-08

Similar Documents

Publication Publication Date Title
US5341818A (en) Guidewire with superelastic distal portion
US6379369B1 (en) Intracorporeal device with NiTi tubular member
US7244319B2 (en) Superelastic guiding member
US5411476A (en) Superelastic guiding member
US5980471A (en) Guidewire with tubular connector
US6352515B1 (en) NiTi alloyed guidewires
EP1791589B1 (fr) Fil de guidage intravasculaire
US5636641A (en) High strength member for intracorporeal use
US6287292B1 (en) Guidewire with a variable stiffness distal portion
EP0739221B1 (fr) Fil de guidage avec partie distale superelastique
EP1426071A2 (fr) Fil de guidage avec partie distale superélastique
US8100837B1 (en) Superelastic guidewire with locally altered properties
WO1995019800A2 (fr) Fil de guidage avec partie distale superelastique
CA2181154A1 (fr) Fil de guidage avec partie distale superelastique

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A2

Designated state(s): CA JP

AL Designated countries for regional patents

Kind code of ref document: A2

Designated state(s): AT BE CH DE DK ES FR GB GR IE IT LU MC NL PT SE

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

Ref document number: 1994907814

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 2181154

Country of ref document: CA

WWP Wipo information: published in national office

Ref document number: 1994907814

Country of ref document: EP

WWG Wipo information: grant in national office

Ref document number: 1994907814

Country of ref document: EP