WO2007081333A1 - Titanium molybdenum alloy guidewires - Google Patents

Titanium molybdenum alloy guidewires Download PDF

Info

Publication number
WO2007081333A1
WO2007081333A1 PCT/US2006/001036 US2006001036W WO2007081333A1 WO 2007081333 A1 WO2007081333 A1 WO 2007081333A1 US 2006001036 W US2006001036 W US 2006001036W WO 2007081333 A1 WO2007081333 A1 WO 2007081333A1
Authority
WO
WIPO (PCT)
Prior art keywords
guidewire
distal end
wire
end portion
coil
Prior art date
Application number
PCT/US2006/001036
Other languages
French (fr)
Inventor
Stephen Nuss
Original Assignee
Minnesota Medical Development, 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 Minnesota Medical Development, Inc. filed Critical Minnesota Medical Development, Inc.
Priority to EP06718147A priority Critical patent/EP1971254A4/en
Priority to EA200801675A priority patent/EA013583B1/en
Priority to CNA2006800510525A priority patent/CN101360448A/en
Priority to CA002636266A priority patent/CA2636266A1/en
Priority to AU2006335336A priority patent/AU2006335336A1/en
Priority to PCT/US2006/001036 priority patent/WO2007081333A1/en
Priority to JP2008550276A priority patent/JP2009523481A/en
Publication of WO2007081333A1 publication Critical patent/WO2007081333A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • 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
    • 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
    • A61L31/08Materials for coatings
    • A61L31/10Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09058Basic structures of guide wires
    • A61M2025/09083Basic structures of guide wires having a coil around a core
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M2025/09133Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque

Definitions

  • This invention relates to the field of medical devices and more particularly to guidewires for use primarily in intra vascular procedures.
  • Guidewires made with a titanium molybdenum alloy allow for a flexible and formable tip with reduced kinldng, high torque, trackability and high column strength.
  • guidewires and other guiding members have sufficient column strength to be pushed through passageways in a patient such as the patient's vascular system with minimal kinking or binding.
  • the distal section of the guidewire must be flexible enough to avoid damaging the blood vessel or other body lumen through which it is advanced.
  • Efforts have been made to improve both the strength and flexibility of guidewires to make them more suitable for their intended uses, but strength for pushing and flexibility for turning without damaging vascular walls tend to be diametrically opposed to one another, in that an increase in one usually involves a decrease in the other.
  • concomitant with the decrease in profile has been a loss in pushability and kink resistance.
  • the distal portion of the guidewire frequently has a spring or coil around a tapered, thinner and therefore softer metal core.
  • the thinner softer core may be too thin to engage the coil and may therefore allow the coil to kink when bent.
  • Guidewires have been made of many different materials. The most popular materials are stainless steel and NiTi alloys such as Nitinol.
  • NiTi guidewires tend to kink. They have good pushability but are not flexible enough to easily bend inside of the vascular system. Stainless steel has good torque qualities for rotating the guidewire but tends to bind when rotated since it does not readily flex. Once the guidewire is kinked, it must be discarded and replaced with a new guidewire. NiTi guidewires tend to be too springy, especially when negotiating a tortuous path in vessels, they do not have good pushability because want to straighten out or return to their original shape. NiTi guidewires will readily get hung up when rotated while extending around a curved path. NiTi guidewires can not be torqued as readily as stainless steel because it is springier. NiTi guidewires tend to have good shape memory. The shape memory makes it difficult for a physician to shape the tip of the guidewire with his fingers for accessing difficult to reach portions of the patient's vascular system.
  • the guidewires need to have distal ends that are soft for bending and turning inside of the blood vessels as they are advanced and so they will not puncture the vessel walls.
  • the most popular guidewires are made out of stainless steel or NiTi alloys. Both of these materials have advantages and drawbacks. A different guidewire material is required to have the desirable qualities of both without as many drawbacks to enhance the performance of guidewires.
  • a titanium molybdenum alloy used to make guidewires for use in passages within a body has several advantages over NiTi and stainless steel guidewires.
  • the titanium molybdenum alloy has properties of high springback, and fiexability that is in between the values of stainless steel and NiTi alloys, which are the two most widely used metals used for making guidewires.
  • the titanium molybdenum alloy has moderate stiffness, about 42% of stainless steel and excellent torque transmission and formability. It is softer and more flexible than stainless steel for better bendability while negotiating though passageways in the body and less likely to puncture the walls of the passageways.
  • the titanium molybdenum alloy is also easier to torque than stainless steel, which tends to bind when the guidewire is in nonlinear passageways.
  • the titanium molybdenum alloy is stronger and has a better pushability than NiTi alloys and is easier to torque because it is less springy and will not bind against the walls of a vessel as much on a non linear path allowing easier rotation of the guidewire.
  • Titanium molybdenum alloys can be easily welded or soldered using standard manufacturing techniques, as opposed to NiTi alloys which are not easy to weld or solder.
  • the titanium molybdenum alloy can be tapered in steps at the distal end producing a softness gradient with the distal end the softest. This allows the distal tip to be more flexible and bend around curves without puncturing the tissue in the passageway.
  • the titanium molybdenum alloy core is softer so it can be make thicker such that a coil around the core engages at a larger diameter and will not kink as it bends.
  • the titanium molybdenum alloy guidewire can be coated with a plastic such as Teflon ® or a hydrophilic coating to make it slipperier.
  • the titanium molybdenum alloy is preferably a mixture of about 78% titanium 11.5% molybdenum 6% zirconium and 4.5% tin by weight.
  • Fig. 1 is a side view of the guidewire.
  • Fig. 2 is a graph comparing stress strain curves for NiTi alloy, stainless steel and TiMo alloy.
  • Guidewires used in passageways within patients are used for a large number of medical procedures. Many of the procedures involve the use of the guide as a guidewire for inserting catheters and other devices in the vascular system of the patient. Guidewires have been made from stainless steel, which is stiff and does not readily bend around in the passageways of the patient. Guidewires are also frequently made using a NiTi alloy which is softer and springier than stainless steel and has a better memory but is not as stiff so that it does not have the pushability of stainless steel. Further NiTi alloy is not as easily bendable so that the distal tip can not be as readily shaped.
  • a guidewire is shown in Fig. 1 having a titanium molybdenum alloy which is has properties between that of stainless steel and NiTi alloys.
  • the titanium molybdenum alloy is easier to use and has better torque, softness and pushability for use in the passageways of patients than guidewires made of other materials.
  • the guidewire in Fig. 1 is made from a titanium molybdenum alloy comprising about 78% titanium, 11.5% molybdenum 6% zirconium and 4.5% tin by weight. The stiffness is about 42% that of stainless steel.
  • the guidewires can be made with a range of values for its alloys.
  • the range of values is approximately 75-83% titanium, 8-14% molybdenum 4-8% zirconium and 2-6% tin by weight.
  • the titanium molybdenum alloy can be deflected more than 42% more than stainless steel with no permanent deformation and has a lower force deflection rate and a higher spring back and flexibility.
  • Nitinol which is a NiTi alloy
  • stainless steel takes a set which is not a desirable quality for a guidewire and, Nitinol is too springy which is not a desirable quality for a guidewire. If a guidewire is too stiff it takes a set and will not easily bend. The stiffness however makes for good pushability allowing for the guidewire to be inserted into a passageway and allows the guidewire to be rotated at the distal end when turned at the proximal end.
  • the stiffness of the guidewire will form arches in the guidewire around curves and will not torque as easily since the entire guidewire will tend to push against the wall of the passage. If the guidewire is too springy and the guidewire is torqued the guidewire will bind in the curved portions in the passageways.
  • a guidewire made from a titanium molybdenum alloy is less springy than NiTi alloys but more springy than stainless steel. Titanium molybdenum alloys are stiffer than NiTi alloys but not as stiff as stainless steel. Therefore titanium molybdenum alloys have desirable properties when used in guidewires.
  • Figure 2 shows the relative stress and strain curves comparing NiTi alloys, curve 35, stainless steel, curve 30 and titanium molybdenum alloy, curve 33 guidewires.
  • Fig. 1 shows a side view of a guidewire 10 having a proximal end 12 and a distal end 14.
  • the distal end 14 has a smaller diameter than the proximal end 12 to make it softer and more easily bendable. It is desirable to have a softer distal end 14 such that the guidewire will bend and follow the curves of a blood vessel or other passageway that the guidewire is inserted into.
  • the guidewire is provided with a rounded distal tip 16 at the tip of the distal end 15 to secure the coil 18 to the distal end 14 and to prevent the tip of the distal end 15 from penetrating tissue in the passageway as the guidewire is being inserted.
  • the guidewire 10 is also provided with a coil 18 which can be made out of platinum, tungsten or similar radio opaque materials to act as a spring, allowing the thinned distal end 14 to bend and yet spring back into place after the guidewire is transported around a curve in the passageway. In the past coils 18 would tend to kink and not return to their original shape if there was a large space between the inside diameter of coil 18 and the core of the distal end 14 of the guidewire 10.
  • the titanium molybdenum alloy has a softness which allows it to have a larger diameter and still be soft enough at the distal end 14 such that the outside diameter of the distal end of the guidewire 10 engages the coil 18 on the inside diameter reducing the space there between and prevents the coil from kinking as the coil 18 and the distal end 14 bend.
  • the coil 18 is wound around the core of the distal end 14 without spaces between the turns and in tight contact with core to prevent kinks from occurring when the guidewire is bent.
  • the titanium molybdenum alloy is made softer by tapering the distal end 14 to reduce the cross section of the guidewire.
  • the tapering at the distal end 14 provides a gradient of softness with the tip of the distal end 15 being the softest.
  • the gradient of softness helps the tip bend while keeping the remainder of the guidewire 10 straighter.
  • the distal end 14 can have a tapered portion 20 which gradually changes the diameter of the guidewire material and provides for a gradient of softness. Abrupt changes in the stiffness of the distal end of the guidewire causes kinking at stress points of the coil, when the distal end is bent.
  • the flexibility (bendability) of the guidewire can continually increase toward the distal end of the guidewire 14 without an abrupt change averting kinking.
  • the proximal end 12 of the guidewire is less flexible and is more uniform and can transmit torque and pushing force with high fidelity.
  • the titanium molybdenum alloy steers better than stainless steel guidewires or NiTi alloy guidewires because it is more flexible than stainless steel yet stiff enough to have torque and is stiffer than NiTi.
  • the distal tip 16 and coil 18 are attached to the titanium molybdenum alloy guidewire 10 by welding or soldering.
  • the titanium molybdenum alloy is more easily welded or soldered than NiTi alloys.
  • the guidewire 10 can be coated with a plastic for making the guidewire slipperier.
  • the guidewire can be coated with Teflon ® or a similar material for a hydrophilic coating.
  • the proximal end 12 of the guidewire 10 can have a coating or surface making it easier to grasp for the doctor to more effectively use the guidewire.
  • the guidewire 10 can be made with lengths of preferably between 20 cm and 500cm and between diameters of 0.005 inches and 0.040 inches with a coil length preferably of between 0.5cm and 100cm.
  • the guidewire 10 can have a coil made from platinum, tungsten or other similar materials for helping to make the coil radio opaque such that it shows up on imaging equipment making the guidewire easier to view while in use.

Abstract

A guidewire for medical use such as in vascular and nonvascular systems. The guidewire made from a titanium molybdenum alloy wire with a composition of approximately 78% titanium 11.5% molybdenum 6% zirconium and 4.5% tin by weight such that it is softer than stainless steel guidewires and stiffer than NiTi alloy guidewires. The distal end of the guidewire is of a smaller diameter and softer than the proximal end and fitted with a coil for springiness such that the distal end will bend when encountering curves in the body passageways. The distal tip may be heat treated for a gradient of softness with the distal tip being the softest. The distal end may also be tapered to provide an additional gradient of softness. A distal tip on the distal end of the guidewire protects the wall of the passageway from being punctured as the guidewire travels through the passageway. The resulting guidewire has properties between those of stainless steel guidewires and NiTi alloy guidewires for better torsion and stiffness characteristics.

Description

Titanium Molybdenum Alloy Guidewires Background of the Invention
I. Field of the Invention:
This invention relates to the field of medical devices and more particularly to guidewires for use primarily in intra vascular procedures. Guidewires made with a titanium molybdenum alloy allow for a flexible and formable tip with reduced kinldng, high torque, trackability and high column strength.
II. Description of the Related Art:
A major requirement for guidewires and other guiding members, whether they are solid wire or tubular members, is that they have sufficient column strength to be pushed through passageways in a patient such as the patient's vascular system with minimal kinking or binding. However, the distal section of the guidewire must be flexible enough to avoid damaging the blood vessel or other body lumen through which it is advanced. Efforts have been made to improve both the strength and flexibility of guidewires to make them more suitable for their intended uses, but strength for pushing and flexibility for turning without damaging vascular walls tend to be diametrically opposed to one another, in that an increase in one usually involves a decrease in the other. There has been a gradual decrease in the profiles or transverse dimensions of commercially available intravascular catheters and guidewires particularly for use in coronary arteries. However, concomitant with the decrease in profile has been a loss in pushability and kink resistance.
The distal portion of the guidewire frequently has a spring or coil around a tapered, thinner and therefore softer metal core. The thinner softer core may be too thin to engage the coil and may therefore allow the coil to kink when bent. Guidewires have been made of many different materials. The most popular materials are stainless steel and NiTi alloys such as Nitinol.
Stainless steel guidewires tend to kink. They have good pushability but are not flexible enough to easily bend inside of the vascular system. Stainless steel has good torque qualities for rotating the guidewire but tends to bind when rotated since it does not readily flex. Once the guidewire is kinked, it must be discarded and replaced with a new guidewire. NiTi guidewires tend to be too springy, especially when negotiating a tortuous path in vessels, they do not have good pushability because want to straighten out or return to their original shape. NiTi guidewires will readily get hung up when rotated while extending around a curved path. NiTi guidewires can not be torqued as readily as stainless steel because it is springier. NiTi guidewires tend to have good shape memory. The shape memory makes it difficult for a physician to shape the tip of the guidewire with his fingers for accessing difficult to reach portions of the patient's vascular system.
The guidewires need to have distal ends that are soft for bending and turning inside of the blood vessels as they are advanced and so they will not puncture the vessel walls.
The most popular guidewires are made out of stainless steel or NiTi alloys. Both of these materials have advantages and drawbacks. A different guidewire material is required to have the desirable qualities of both without as many drawbacks to enhance the performance of guidewires.
Summary of the Invention
A titanium molybdenum alloy used to make guidewires for use in passages within a body has several advantages over NiTi and stainless steel guidewires. The titanium molybdenum alloy has properties of high springback, and fiexability that is in between the values of stainless steel and NiTi alloys, which are the two most widely used metals used for making guidewires.
The titanium molybdenum alloy has moderate stiffness, about 42% of stainless steel and excellent torque transmission and formability. It is softer and more flexible than stainless steel for better bendability while negotiating though passageways in the body and less likely to puncture the walls of the passageways. The titanium molybdenum alloy is also easier to torque than stainless steel, which tends to bind when the guidewire is in nonlinear passageways. The titanium molybdenum alloy is stronger and has a better pushability than NiTi alloys and is easier to torque because it is less springy and will not bind against the walls of a vessel as much on a non linear path allowing easier rotation of the guidewire.
Titanium molybdenum alloys can be easily welded or soldered using standard manufacturing techniques, as opposed to NiTi alloys which are not easy to weld or solder.
The titanium molybdenum alloy can be tapered in steps at the distal end producing a softness gradient with the distal end the softest. This allows the distal tip to be more flexible and bend around curves without puncturing the tissue in the passageway. The titanium molybdenum alloy core is softer so it can be make thicker such that a coil around the core engages at a larger diameter and will not kink as it bends.
The titanium molybdenum alloy guidewire can be coated with a plastic such as Teflon ® or a hydrophilic coating to make it slipperier.
The titanium molybdenum alloy is preferably a mixture of about 78% titanium 11.5% molybdenum 6% zirconium and 4.5% tin by weight.
Objects of the Invention
It is an object of the invention to provide a guidewire with the right amount of stiffness to easily advance the guidewire.
It is an object of the invention to provide a guidewire with the right amount of softness to bend around curves in a passageway without puncturing the walls of the passageway.
It is an object of the invention to provide a guidewire with rotatability such that it can be torqued without binding up in a nonlinear passageway.
It is an object of the invention to provide a guidewire with a coil at the distal end of the guidewire which is less likely to kink when bent.
It is an object of the invention to provide a guidewire with a softness gradient at its distal end. It is an object of the invention to provide a guidewire which steers better in the passageways of the patient.
It is an object of the invention to provide a guidewire which is easily weldable and solderable.
It is an object of the invention to provide a guidewire with an easily shaped tip. It is an object of the invention to provide a guidewire with a radio opaque tip.
It is an object of the invention to provide a guidewire having a higher kink resistance than a stainless steel guidewire.
It is an object of the invention to provide a guidewire having less springiness than a NiTi alloy guidewire.
It is an object of the invention to provide a guidewire having a coating to make is easier to advance the guidewire though the vascular system of the patient.
Other objects, advantages and novel features of the present invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawing.
Brief Description of the Drawings Fig. 1 is a side view of the guidewire.
Fig. 2 is a graph comparing stress strain curves for NiTi alloy, stainless steel and TiMo alloy.
Description of the Preferred Embodiments
Guidewires used in passageways within patients are used for a large number of medical procedures. Many of the procedures involve the use of the guide as a guidewire for inserting catheters and other devices in the vascular system of the patient. Guidewires have been made from stainless steel, which is stiff and does not readily bend around in the passageways of the patient. Guidewires are also frequently made using a NiTi alloy which is softer and springier than stainless steel and has a better memory but is not as stiff so that it does not have the pushability of stainless steel. Further NiTi alloy is not as easily bendable so that the distal tip can not be as readily shaped.
A guidewire is shown in Fig. 1 having a titanium molybdenum alloy which is has properties between that of stainless steel and NiTi alloys. The titanium molybdenum alloy is easier to use and has better torque, softness and pushability for use in the passageways of patients than guidewires made of other materials. The guidewire in Fig. 1 is made from a titanium molybdenum alloy comprising about 78% titanium, 11.5% molybdenum 6% zirconium and 4.5% tin by weight. The stiffness is about 42% that of stainless steel. Alternatively the guidewires can be made with a range of values for its alloys.
The range of values is approximately 75-83% titanium, 8-14% molybdenum 4-8% zirconium and 2-6% tin by weight.
The titanium molybdenum alloy can be deflected more than 42% more than stainless steel with no permanent deformation and has a lower force deflection rate and a higher spring back and flexibility. Comparing stainless steel to Nitinol, which is a NiTi alloy, stainless steel takes a set which is not a desirable quality for a guidewire and, Nitinol is too springy which is not a desirable quality for a guidewire. If a guidewire is too stiff it takes a set and will not easily bend. The stiffness however makes for good pushability allowing for the guidewire to be inserted into a passageway and allows the guidewire to be rotated at the distal end when turned at the proximal end. However if the guidewire does not bend easily and there is a nonlinear passageway that the guidewire must negotiate, the stiffness of the guidewire will form arches in the guidewire around curves and will not torque as easily since the entire guidewire will tend to push against the wall of the passage. If the guidewire is too springy and the guidewire is torqued the guidewire will bind in the curved portions in the passageways.
A guidewire made from a titanium molybdenum alloy is less springy than NiTi alloys but more springy than stainless steel. Titanium molybdenum alloys are stiffer than NiTi alloys but not as stiff as stainless steel. Therefore titanium molybdenum alloys have desirable properties when used in guidewires. Figure 2 shows the relative stress and strain curves comparing NiTi alloys, curve 35, stainless steel, curve 30 and titanium molybdenum alloy, curve 33 guidewires. The graph charts the percentage of maximum bending moment (inch=pounds) as related to the angular deflection (degrees). It shows the percentage that each wire returns to its original shape after being bent to a given moment. As shown on the chart, when deflected, Nitinol returns to its shape, stainless steel returns to only about 5% of its original shape and titanium molybdenum alloy such as Beta III alloy returns to about 50% of its original shape. Thus the titanium molybdenum alloy such as Beta III alloy exhibits springback properties between Nitinol and Stainless steel. Fig. 1 shows a side view of a guidewire 10 having a proximal end 12 and a distal end 14. The distal end 14 has a smaller diameter than the proximal end 12 to make it softer and more easily bendable. It is desirable to have a softer distal end 14 such that the guidewire will bend and follow the curves of a blood vessel or other passageway that the guidewire is inserted into. The guidewire is provided with a rounded distal tip 16 at the tip of the distal end 15 to secure the coil 18 to the distal end 14 and to prevent the tip of the distal end 15 from penetrating tissue in the passageway as the guidewire is being inserted. The guidewire 10 is also provided with a coil 18 which can be made out of platinum, tungsten or similar radio opaque materials to act as a spring, allowing the thinned distal end 14 to bend and yet spring back into place after the guidewire is transported around a curve in the passageway. In the past coils 18 would tend to kink and not return to their original shape if there was a large space between the inside diameter of coil 18 and the core of the distal end 14 of the guidewire 10. The titanium molybdenum alloy has a softness which allows it to have a larger diameter and still be soft enough at the distal end 14 such that the outside diameter of the distal end of the guidewire 10 engages the coil 18 on the inside diameter reducing the space there between and prevents the coil from kinking as the coil 18 and the distal end 14 bend. The coil 18 is wound around the core of the distal end 14 without spaces between the turns and in tight contact with core to prevent kinks from occurring when the guidewire is bent.
The titanium molybdenum alloy is made softer by tapering the distal end 14 to reduce the cross section of the guidewire. The tapering at the distal end 14 provides a gradient of softness with the tip of the distal end 15 being the softest. The gradient of softness helps the tip bend while keeping the remainder of the guidewire 10 straighter. The distal end 14 can have a tapered portion 20 which gradually changes the diameter of the guidewire material and provides for a gradient of softness. Abrupt changes in the stiffness of the distal end of the guidewire causes kinking at stress points of the coil, when the distal end is bent. By having a larger number of tapered sections with small changes in the diameter the flexibility (bendability) of the guidewire can continually increase toward the distal end of the guidewire 14 without an abrupt change averting kinking. The proximal end 12 of the guidewire is less flexible and is more uniform and can transmit torque and pushing force with high fidelity. The titanium molybdenum alloy steers better than stainless steel guidewires or NiTi alloy guidewires because it is more flexible than stainless steel yet stiff enough to have torque and is stiffer than NiTi.
The distal tip 16 and coil 18 are attached to the titanium molybdenum alloy guidewire 10 by welding or soldering. The titanium molybdenum alloy is more easily welded or soldered than NiTi alloys.
The guidewire 10 can be coated with a plastic for making the guidewire slipperier. The guidewire can be coated with Teflon ® or a similar material for a hydrophilic coating. The proximal end 12 of the guidewire 10 can have a coating or surface making it easier to grasp for the doctor to more effectively use the guidewire.
The guidewire 10 can be made with lengths of preferably between 20 cm and 500cm and between diameters of 0.005 inches and 0.040 inches with a coil length preferably of between 0.5cm and 100cm. The guidewire 10 can have a coil made from platinum, tungsten or other similar materials for helping to make the coil radio opaque such that it shows up on imaging equipment making the guidewire easier to view while in use.
Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that, within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.
What is claimed is:

Claims

Claims
1. An intravascular guidewire adapted for insertion into the vascular system of a patient during the course of a catheterization procedure, comprising: a titanium molybdenum alloy wire having approximately 78% titanium, 11.5% molybdenum, 6% zirconium and 4.5% tin by weight, the wire having a diameter in a range of from 0.005 inch and 0.040 inch over a predetermined length dimension thereof, said wire having a proximal end portion and a distal end portion that is tapered to a lesser diameter than the diameter of the proximal end portion and that terminates in a rounded distal tip.
2. The guidewire as in claim 1 having, the distal end portion with a helical coil attached, and where the coil touches a distal tip of the guidewire, the coil providing springiness proximate the distal tip inhibiting kinking of the coil.
3. The guidewire as in claim 1 having, a rounded distal tip member on the end of the distal end portion of the wire to prevent the distal end of the wire from penetrating tissue in the wall of a body lumen upon passage of the guidewire through the body lumen.
4. The guidewire as in claim 1 wherein, the wire has a lubricious polymer coating.
5. The guidewire as in claim 1 wherein, the wire has a hydrophilic coating.
6. An intravascular guidewire adapted for insertion into the vascular system of a patient during the course of a catheterization procedure comprising a titanium molybdenum alloy wire having approximately between about 75 % and about 83 %titanium, between about 8 % and about 14 %molybdenum, between about 4 % and about 8 % zirconium and between about 2 % and about 6 % tin by weight, the wire having a diameter in a range of from 0.005 inch and 0.040 inch over a predetermined length dimension thereof, said wire having a proximal end portion and a distal end portion where the distal end portion is tapered to a lesser diameter than the diameter of the proximal end portion and terminates in a rounded distal tip.
7. The guidewire as in claim 6 having a coil attached to a distal tip member such that the coil provides springiness at the distal tip portion to prevent kinking of the coil.
8. The guidewire as in claim 6 having, a distal tip member on the distal end portion to prevent the distal end of the wire from penetrating tissue in the wall of said body passageway.
9. The guidewire as in claim 6 wherein, the wire has a lubricious polymer coating thereon.
10. The guidewire as in claim 6 wherein, the guidewire has a hydrophilic coating thereon.
PCT/US2006/001036 2006-01-12 2006-01-12 Titanium molybdenum alloy guidewires WO2007081333A1 (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
EP06718147A EP1971254A4 (en) 2006-01-12 2006-01-12 Titanium molybdenum alloy guidewires
EA200801675A EA013583B1 (en) 2006-01-12 2006-01-12 Titanium molybdenium alloy guidewires
CNA2006800510525A CN101360448A (en) 2006-01-12 2006-01-12 Conductive filament of titanium molybdenum alloy
CA002636266A CA2636266A1 (en) 2006-01-12 2006-01-12 Titanium molybdenum alloy guidewires
AU2006335336A AU2006335336A1 (en) 2006-01-12 2006-01-12 Titanium molybdenum alloy guidewires
PCT/US2006/001036 WO2007081333A1 (en) 2006-01-12 2006-01-12 Titanium molybdenum alloy guidewires
JP2008550276A JP2009523481A (en) 2006-01-12 2006-01-12 Titanium / molybdenum alloy guide wire

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2006/001036 WO2007081333A1 (en) 2006-01-12 2006-01-12 Titanium molybdenum alloy guidewires

Publications (1)

Publication Number Publication Date
WO2007081333A1 true WO2007081333A1 (en) 2007-07-19

Family

ID=38256622

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2006/001036 WO2007081333A1 (en) 2006-01-12 2006-01-12 Titanium molybdenum alloy guidewires

Country Status (7)

Country Link
EP (1) EP1971254A4 (en)
JP (1) JP2009523481A (en)
CN (1) CN101360448A (en)
AU (1) AU2006335336A1 (en)
CA (1) CA2636266A1 (en)
EA (1) EA013583B1 (en)
WO (1) WO2007081333A1 (en)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102499725B (en) * 2011-10-21 2015-09-02 李延辉 Micro trauma couple puncture and intubation instrument
CN104014067B (en) * 2013-03-01 2016-04-13 广州金导医疗科技有限公司 There is medical guiding wire and the manufacture method thereof of insulating coating
CN104095679A (en) * 2013-04-12 2014-10-15 上海微创电生理医疗科技有限公司 Multiple-electrode ablation catheter
CN103480077A (en) * 2013-08-26 2014-01-01 谷村哲明 Guide wire
JP2017500925A (en) * 2013-11-26 2017-01-12 ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. Medical device for accessing a body lumen
CN103623494B (en) * 2013-12-12 2016-02-24 西北有色金属研究院 A kind of titanium alloy guide wire for surgical interventional therapy
CN105796093B (en) * 2016-05-11 2019-02-01 苏州康晟通医疗科技有限公司 Central venous catheter external member
CN105832329A (en) * 2016-05-11 2016-08-10 苏州康晟通医疗科技有限公司 Electrocardiogram monitoring system
KR20180048435A (en) * 2016-09-14 2018-05-10 아사히 인텍크 가부시키가이샤 Connection structure and guide wire having the connection structure
CN107115590A (en) * 2017-05-27 2017-09-01 苏州朗特斯医疗科技有限公司 Carry the single-chamber sacculus dilating catheter of seal wire
CN109770826A (en) * 2019-03-06 2019-05-21 南充市中医医院 A kind of Sigmoidoscope is assisted into lens device
CN110237402B (en) * 2019-05-22 2021-10-08 中国人民解放军陆军军医大学第一附属医院 Guide wire capable of forming loop
CN110681031A (en) * 2019-11-11 2020-01-14 湖南埃普特医疗器械有限公司 Contrast guide wire and preparation method thereof
CN113041159A (en) * 2021-03-23 2021-06-29 昆明医科大学第二附属医院 Novel stomach tube convenient to put into pylorus

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4817600A (en) * 1987-05-22 1989-04-04 Medi-Tech, Inc. Implantable filter
US4894100A (en) * 1987-01-08 1990-01-16 Tokin Corporation Ti-Ni-V shape memory alloy
US5630840A (en) * 1993-01-19 1997-05-20 Schneider (Usa) Inc Clad composite stent
US5951793A (en) * 1995-07-12 1999-09-14 The Furukawa Electric Co., Ltd. Ni-Ti-Pd superelastic alloy material, its manufacturing method, and orthodontic archwire made of this alloy material
US6132389A (en) * 1998-04-23 2000-10-17 Advanced Cardiovascular Systems, Inc. Proximally tapered guidewire tip coil
US6375628B1 (en) * 1997-03-06 2002-04-23 Medtronic Percusurge, Inc. Hollow medical wires and methods of constructing same
US6402859B1 (en) * 1999-09-10 2002-06-11 Terumo Corporation β-titanium alloy wire, method for its production and medical instruments made by said β-titanium alloy wire

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002094334A1 (en) * 2001-05-21 2002-11-28 Medtronic, Inc. Malleable elongated medical device

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4894100A (en) * 1987-01-08 1990-01-16 Tokin Corporation Ti-Ni-V shape memory alloy
US4817600A (en) * 1987-05-22 1989-04-04 Medi-Tech, Inc. Implantable filter
US5630840A (en) * 1993-01-19 1997-05-20 Schneider (Usa) Inc Clad composite stent
US5951793A (en) * 1995-07-12 1999-09-14 The Furukawa Electric Co., Ltd. Ni-Ti-Pd superelastic alloy material, its manufacturing method, and orthodontic archwire made of this alloy material
US6375628B1 (en) * 1997-03-06 2002-04-23 Medtronic Percusurge, Inc. Hollow medical wires and methods of constructing same
US6132389A (en) * 1998-04-23 2000-10-17 Advanced Cardiovascular Systems, Inc. Proximally tapered guidewire tip coil
US6402859B1 (en) * 1999-09-10 2002-06-11 Terumo Corporation β-titanium alloy wire, method for its production and medical instruments made by said β-titanium alloy wire

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1971254A4 *

Also Published As

Publication number Publication date
JP2009523481A (en) 2009-06-25
AU2006335336A1 (en) 2007-07-19
EP1971254A1 (en) 2008-09-24
EA013583B1 (en) 2010-06-30
CA2636266A1 (en) 2007-07-19
EP1971254A4 (en) 2010-08-11
CN101360448A (en) 2009-02-04
EA200801675A1 (en) 2008-12-30

Similar Documents

Publication Publication Date Title
WO2007081333A1 (en) Titanium molybdenum alloy guidewires
CA2403796C (en) Coated wire
US5957865A (en) Flexible catheter guidewire
US6306105B1 (en) High performance coil wire
JP5925145B2 (en) Intravascular guidewire
US7993286B2 (en) Composite guidewire
US8167821B2 (en) Multiple diameter guidewire
JP4166321B2 (en) Superelastic guidewire with moldable tip
US9144661B2 (en) Reinforced elongate medical device and method of manufacture
US20100228150A1 (en) Neuro guidewire
US9061124B2 (en) High-modulus superelastic alloy wire for medical and dental purposes
WO2013116379A1 (en) Guide wire core wire made from a substantially titanium-free alloy for enhanced guide wire steering response
US8777873B2 (en) Wire guide having a rib for coil attachment
US7468045B2 (en) Titanium molybdenum alloy guidewire
JP2004016359A (en) Guide wire
WO2010060889A1 (en) Microcatheter
KR20080085160A (en) Titanium molybdenum alloy guidewires
WO2010023108A1 (en) Multifunction catheter
JP4855448B2 (en) Guide wire manufacturing method
EP1523366A1 (en) Guidewire with tapered flexible core segment

Legal Events

Date Code Title Description
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: 2006335336

Country of ref document: AU

WWE Wipo information: entry into national phase

Ref document number: 5536/DELNP/2008

Country of ref document: IN

WWE Wipo information: entry into national phase

Ref document number: 2636266

Country of ref document: CA

WWE Wipo information: entry into national phase

Ref document number: 2006718147

Country of ref document: EP

WWE Wipo information: entry into national phase

Ref document number: 1020087016713

Country of ref document: KR

ENP Entry into the national phase

Ref document number: 2006335336

Country of ref document: AU

Date of ref document: 20060112

Kind code of ref document: A

WWE Wipo information: entry into national phase

Ref document number: 2008550276

Country of ref document: JP

WWE Wipo information: entry into national phase

Ref document number: 200680051052.5

Country of ref document: CN

NENP Non-entry into the national phase

Ref country code: DE

WWE Wipo information: entry into national phase

Ref document number: 200801675

Country of ref document: EA