EP0989820A4 - Glass core guidewire compatible with magnetic resonance having reinforcing fibers - Google Patents

Glass core guidewire compatible with magnetic resonance having reinforcing fibers

Info

Publication number
EP0989820A4
EP0989820A4 EP98926103A EP98926103A EP0989820A4 EP 0989820 A4 EP0989820 A4 EP 0989820A4 EP 98926103 A EP98926103 A EP 98926103A EP 98926103 A EP98926103 A EP 98926103A EP 0989820 A4 EP0989820 A4 EP 0989820A4
Authority
EP
European Patent Office
Prior art keywords
guidewire
magnetic
core
distal tip
reinforcing fibers
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP98926103A
Other languages
German (de)
French (fr)
Other versions
EP0989820A1 (en
Inventor
Wenzel Franz Hurtak
Frans Mous
Cornelis Philipus Nap
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cordis Corp
Original Assignee
Cordis Corp
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 Cordis Corp filed Critical Cordis Corp
Publication of EP0989820A1 publication Critical patent/EP0989820A1/en
Publication of EP0989820A4 publication Critical patent/EP0989820A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01RMEASURING ELECTRIC VARIABLES; MEASURING MAGNETIC VARIABLES
    • G01R33/00Arrangements or instruments for measuring magnetic variables
    • G01R33/20Arrangements or instruments for measuring magnetic variables involving magnetic resonance
    • G01R33/28Details of apparatus provided for in groups G01R33/44 - G01R33/64
    • G01R33/285Invasive instruments, e.g. catheters or biopsy needles, specially adapted for tracking, guiding or visualization by NMR
    • 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
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0127Magnetic means; Magnetic markers
    • 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
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3954Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
    • 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
    • A61M2025/09075Basic structures of guide wires having a core without a coil possibly combined with a sheath

Definitions

  • the present invention relates generally to intravascular medical devices, and more particularly, to a medical guidewire having reinforcing fibers for use with magnetic resonance
  • Such guidewires may be used in medical procedures for both diagnostic and
  • Guidewires are used in a wide variety of medical procedures, most often in conjunction with one or more other medical devices, including catheters.
  • catheters may be any of various types, such as angiography or angioplasty, but should in any event have a tubular lumen
  • guidewires are often long, thin metal wires that generally taper from one diameter at a proximal end which remains outside the body of the patient, to a smaller diameter at the opposite distal end.
  • vascular guidewires are often more than five feet long and have a maximum outer diameter of approximately 0.035 inches. The diameter of the core
  • wire is generally ground down precisely in a series of alternating tapering portions and constant
  • the guidewire distal tip is usually very flexible, both to avoid vascular trauma and so
  • Guidewires are designed to resist this twisting force or torsion, so that as the guidewire
  • the distal tip tends to rotate through about the same angle.
  • a floppy spring is often affixed to the extreme distal tip of the guidewire for flexibility.
  • the core wire tapers in steps to a distal portion
  • the flexible spring at the guidewire distal tip is arranged to selectively control its brightness on an X-ray
  • MRI magnetic resonance imaging
  • MR magnetic resonance
  • the present invention provides a guidewire compatible for use with magnetic resonance systems, made from a non-metallic material with a high specific electric impedance. Accordingly, this material will resist any electrical eddy currents in the guidewire from being generated by variations in the high-frequency field.
  • An acceptable class of materials is glass, which are all electrical insulators. A guidewire having a major portion constructed of a glass material should therefore have the advantages of not disturbing the MR
  • Figure 1 is a perspective view of a guidewire for use with magnetic resonance systems, arranged according to the present invention
  • Figure 2 is a cross-sectional view of an intermediate portion of the guidewire of Figure 1;
  • Figure 3 is a cross-sectional view of a proximal end portion of the guidewire of Figure
  • Figure 4 is a perspective view of a guidewire for use with magnetic resonance
  • Figures 5-7 are cross-sectional views of a portion of various guidewires arranged
  • Figure 8 is a perspective view of a guidewire for use with magnetic resonance
  • Figure 9 is a cross-sectional view of an intermediate portion of the guidewire of
  • Figure 10 is a cross-sectional view of a proximal end portion of the guidewire of Figure 8.
  • Figures 1 1-13 are side elevation views of distal portions of guidewires arranged
  • FIG. 1 a perspective view of a stent according to a preferred embodiment of the present invention is shown generally at 1.
  • the medical guidewire 1 is intended for use in intravascular medical procedures involving the use of magnetic resonance
  • Guidewire 1 is constructed of a basic body 2 and a distal tip portion 3.
  • the distal tip of guidewire 1 includes several markers 4
  • the proximal portion of the basic body 2 is illustrated in Figure 3, and incorporates a
  • the coated glass body 5 extends for substantially the length of the guidewire and is
  • Markers 4 are visible under MR because they are susceptible to slightly distorting the uniformity of the magnetic resonance field, causing the magnetic field to become what is called “inhomogeneous.”
  • the material of the markers 4 is selected specifically for this
  • Dysprosium Oxide (Dy O 3 ).
  • the glass body 5 is preferably made of a glass material having a high specific electric impedance, such as fiberglass, silica, or quartz.
  • the coating 6 adds strength to the glass core 5, in that the coating allows the glass
  • the coated glass core 5 may endure strain as high as 12%.
  • the outer polymer sheath 7 may be constructed from any of a variety of materials, including nylon.
  • An additional advantage of the design of the present invention is that the polymer sheath 7 can maintain the physical integrity of the guidewire, even if the glass core 5
  • the polymer sheath 7 may be provided with a
  • lubricious or hydrophilic coating as generally known in the art.
  • the distal tip portion 3 of the guidewire 1 may be formed of a plastic, as shown in Figure 2, or of a metal as shown in Figures 8-13.
  • the outer diameter of guidewire 1 preferably tapers to a smaller diameter toward the distal tip, as illustrated in Figures 8-13.
  • the metal tip portion may be stainless steel or more preferably nickel titanium, or nitinol.
  • the length of the metal distal tip segment is substantially shorter than the wavelength of the magnetic resonance field in which the guidewire is used.
  • the glue 8 is preferably of a type that cures upon exposure to ultraviolet light. Accordingly, the polymer sheath 7 should be transparent, to allow the glue 8 to be exposed to the ultraviolet light after portions of the guidewire 1 are assembled as shown in Figures 1-3.
  • An embodiment of the present invention is depicted in Figures 4-7, in which a
  • guidewire 11 has a proximal portion 12 and a distal tip portion 13.
  • Guidewire 11 has a
  • fibers 18 may be embedded in a polymer matrix 19.
  • a multiplicity of short reinforcing fibers 20 can be provided in a polymer matrix 21 ,
  • the present invention includes the provision of reinforcing fibers in either the core of the guidewire or the plastic sheath surrounding the
  • the reinforcing fibers may be of any suitable material, such as carbon, borium,
  • the guidewire of the present invention may also be constructed of more than one glass
  • core body all of which may be clad as a unit with a single protective coating.

Abstract

A medical guidewire (1) is intended for use in intravascular medical procedures involving the use of magnetic resonance systems. The guidewire (1) has a body (2) and a distal tip portion (3). The distal tip of the guidewire (1) includes several markers (4) embedded in the distal tip portion (3), which are more visible under MR than the remainder of the guidewire.

Description

GLASS CORE GUIDEWIRE COMPATIBLE WITH MAGNETIC RESONANCE
HAVING REINFORCING FIBERS
BACKGROUND AND SUMMARY OF THE INVENTION
1. Technical Background:
The present invention relates generally to intravascular medical devices, and more particularly, to a medical guidewire having reinforcing fibers for use with magnetic resonance
systems. Such guidewires may be used in medical procedures for both diagnostic and
interventional purposes.
2. Discussion:
Guidewires are used in a wide variety of medical procedures, most often in conjunction with one or more other medical devices, including catheters. Such a catheter may be any of various types, such as angiography or angioplasty, but should in any event have a tubular lumen
or other guiding means through which the guidewire can be advanced or withdrawn.
Structurally, guidewires are often long, thin metal wires that generally taper from one diameter at a proximal end which remains outside the body of the patient, to a smaller diameter at the opposite distal end. Specifically, vascular guidewires are often more than five feet long and have a maximum outer diameter of approximately 0.035 inches. The diameter of the core
wire is generally ground down precisely in a series of alternating tapering portions and constant
diameter sections, to develop a selectively engineered flexibility profile along the length of the
guidewire. The guidewire distal tip is usually very flexible, both to avoid vascular trauma and so
that it can be selectively bent and twisted to advance it along a desired vascular path.
Guidewires are designed to resist this twisting force or torsion, so that as the guidewire
proximal end is twisted or rotated, the distal tip tends to rotate through about the same angle.
In addition, a floppy spring is often affixed to the extreme distal tip of the guidewire for flexibility.
A good example of a current guidewire is described in the commonly assigned United
States Patent number 4,846,186, issued to Box et al. on July 1 1, 1989, which is incorporated in this disclosure by reference. The Box patent shows a guidewire suitable for both
diagnostic and therapeutic or interventional procedures, having a Teflon coating from the
proximal end along a majority of its length. The core wire tapers in steps to a distal portion
that is flattened and surrounded by a flexible spring, which is brazed to the extreme distal end
of the core wire to form a rounded tip.
As the body of the patient is of course opaque, physicians commonly use fluoroscopy
or X-ray video cameras to track the position of the guidewire and to construct real-time images of the patient's vasculature. The visibility and brightness of selected portions of the guidewire is a relatively important feature, as described in the commonly assigned United States Patent number 5,259,393, issued to Corso, Jr. et al. on November 9, 1993, and United States Patent number 5,267,574, issued to Viera et al. on December 7, 1993. Both of these
patents are incorporated in this disclosure by reference. In the Corso patent, the flexible spring at the guidewire distal tip is arranged to selectively control its brightness on an X-ray
fluoroscope, or radiopacity. Likewise, the Viera patent discloses a plastic sleeve shrunk
around an intermediate section of the guidewire, and several radiopaque marker bands. In contrast to fluoroscopy, another method of visualizing the patient is magnetic
resonance imaging, referred to as MRI. Other medical fields, such as neurology, often use
procedures which are performed under MRI instead of X-ray fluoroscopy. Accordingly, it is
also desirable to image the anatomy and to track the position of intravascular devices, including catheters and guidewires, using magnetic resonance (MR) systems.
For these applications, it is desirable to make guidewires usable and compatible with MRI techniques. However, a metal guidewire may be too visible under MR, brightly washing out the screen and obscuring important features. This halo phenomenon is called an
"artifact," and renders the image useless. Another issue with the use of a metal guidewire under MR is the induction of eddy currents in the metal, caused by distortion of the magnetic
field. These eddy currents can generate heat and may increase the local temperature of the
surrounding tissue and body fluids, thus possibly damaging the tissue or causing the blood to
coagulate.
It is an object of the present invention to provide a guidewire having the desired physical features, including torsion and flexibility, while also avoiding the creation of undesirable artifacts in the MR image or the generation of heat.
The present invention provides a guidewire compatible for use with magnetic resonance systems, made from a non-metallic material with a high specific electric impedance. Accordingly, this material will resist any electrical eddy currents in the guidewire from being generated by variations in the high-frequency field. An acceptable class of materials is glass, which are all electrical insulators. A guidewire having a major portion constructed of a glass material should therefore have the advantages of not disturbing the MR
field and images, as well as resisting the generation of heat. These and various other objects, advantages and features of the invention will become
apparent from the following description and claims, when considered in conjunction with the
appended drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a perspective view of a guidewire for use with magnetic resonance systems, arranged according to the present invention;
Figure 2 is a cross-sectional view of an intermediate portion of the guidewire of Figure 1;
Figure 3 is a cross-sectional view of a proximal end portion of the guidewire of Figure
1 ;
Figure 4 is a perspective view of a guidewire for use with magnetic resonance
systems, arranged according the present invention;
Figures 5-7 are cross-sectional views of a portion of various guidewires arranged
according to certain embodiments of the present invention; Figure 8 is a perspective view of a guidewire for use with magnetic resonance
systems, illustrating the reinforcing fibers of the present invention;
Figure 9 is a cross-sectional view of an intermediate portion of the guidewire of
Figure 8;
Figure 10 is a cross-sectional view of a proximal end portion of the guidewire of Figure 8; and
Figures 1 1-13 are side elevation views of distal portions of guidewires arranged
according to alternative embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
The following description of the preferred embodiments of the present invention is
merely illustrative in nature, and as such it does not limit in any way the present invention, its
application, or uses. Numerous modifications may be made by those skilled in the art without
departing from the true spirit and scope of the invention.
Referring to Figure 1, a perspective view of a stent according to a preferred embodiment of the present invention is shown generally at 1. The medical guidewire 1 is intended for use in intravascular medical procedures involving the use of magnetic resonance
systems, including both magnetic resonance imaging and magnetic resonance tracking of the guidewire's position within the body of the patient. Guidewire 1 is constructed of a basic body 2 and a distal tip portion 3. The distal tip of guidewire 1 includes several markers 4
embedded in the distal tip portion 3, which are more visible under MR than the remainder of
the guidewire.
The proximal portion of the basic body 2 is illustrated in Figure 3, and incorporates a
relatively long, thin core or glass body 5, which may be encased with a protective coating 6.
The coated glass body 5 extends for substantially the length of the guidewire and is
surrounded with a polymer sheath 7, which is adhered to the glass body 5 with a glue 8.
Markers 4 are visible under MR because they are susceptible to slightly distorting the uniformity of the magnetic resonance field, causing the magnetic field to become what is called "inhomogeneous." The material of the markers 4 is selected specifically for this
property, and acceptable materials include Dysprosium Oxide (Dy O3).
The glass body 5 is preferably made of a glass material having a high specific electric impedance, such as fiberglass, silica, or quartz. The coating 6 adds strength to the glass core 5, in that the coating allows the glass
core 5 to be bent through a sharper turn or more tortuous path without breaking. Indeed, it
has been found that the coated glass core 5 may endure strain as high as 12%. A suitable
material for the coating 6 has been found to be polyimide. The outer polymer sheath 7 may be constructed from any of a variety of materials, including nylon. An additional advantage of the design of the present invention is that the polymer sheath 7 can maintain the physical integrity of the guidewire, even if the glass core 5
should unexpectedly break. Of course, the polymer sheath 7 may be provided with a
lubricious or hydrophilic coating, as generally known in the art.
An intermediate portion of the guidewire is depicted in Figure 2, which focuses on a
region near the transition at arrow II between the glass core proximal portion of the basic
body, referred to as the "transition point."
The distal tip portion 3 of the guidewire 1 may be formed of a plastic, as shown in Figure 2, or of a metal as shown in Figures 8-13. The outer diameter of guidewire 1 preferably tapers to a smaller diameter toward the distal tip, as illustrated in Figures 8-13. The metal tip portion may be stainless steel or more preferably nickel titanium, or nitinol. Preferably, the length of the metal distal tip segment is substantially shorter than the wavelength of the magnetic resonance field in which the guidewire is used.
The glue 8 is preferably of a type that cures upon exposure to ultraviolet light. Accordingly, the polymer sheath 7 should be transparent, to allow the glue 8 to be exposed to the ultraviolet light after portions of the guidewire 1 are assembled as shown in Figures 1-3. An embodiment of the present invention is depicted in Figures 4-7, in which a
guidewire 11 has a proximal portion 12 and a distal tip portion 13. Guidewire 11 has a
plastic sheath 16 in which a number of reinforcing fibers have been embedded. Sheath 16
may be shrunk around a bundle of fibers 17, or the sheath 16 may be braided with the reinforcing fibers. Alternatively, fibers 18 may be embedded in a polymer matrix 19. In addition, a multiplicity of short reinforcing fibers 20 can be provided in a polymer matrix 21 ,
surrounded by a coating 12. Accordingly, the present invention includes the provision of reinforcing fibers in either the core of the guidewire or the plastic sheath surrounding the
core. The reinforcing fibers may be of any suitable material, such as carbon, borium,
aramide, or glass.
The guidewire of the present invention may also be constructed of more than one glass
core body, all of which may be clad as a unit with a single protective coating.
It should be understood that an unlimited number of configurations for the present invention can be realized. The foregoing discussion describes merely exemplary
embodiments illustrating the principles of the present invention, the scope of which is recited in the following claims. Those skilled in the art will readily recognize from the description,
claims, and drawings that numerous changes and modifications can be made without departing from the spirit and scope of the invention.

Claims

What is claimed is:
1. A medical guidewire for use in intravascular medical procedures and compatible
with magnetic resonance, the guidewire having proximal and distal ends, comprising: a relatively long, thin core extending for substantially the length of the guidewire, the core being made of a glass having a high specific electric impedance; a polymer sheath surrounding the core;
a plurality of reinforcing fibers affixed to at least one of the core and the polymer
sheath, to enhance the flexibility and torsion characteristics of the guidewire; and
at least one marker positioned near a distal end of the guidewire, wherein the
marker is visible under magnetic resonance due to susceptibility-induced magnetic field
inhomogeneity.
2. The medical guidewire of Claim 1, further comprising a relatively short distal tip segment made of metal components affixed to the glass core at a transition point, wherein the
length of the metal distal tip segment is substantially shorter than the wavelength of a magnetic resonance field.
3. The magnetic guidewire of Claim 1, wherein the reinforcing fibers are affixed to
the core.
4. The magnetic guidewire of Claim 1 , wherein the reinforcing fibers are affixed to
the polymer sheath.
5. The magnetic guidewire of Claim 4, wherein the material of the reinforcing fibers
is selected from the group consisting of carbon, borium, aramide, and glass.
6. The magnetic guidewire of Claim 1, wherein the material of the core is selected from the group consisting of fiberglass, silica, and quartz.
7. The magnetic guidewire of Claim 2, wherein the material of the metal distal tip segment is nitinol.
8. The magnetic guidewire of Claim 1 , wherein a distal segment of the glass core
tapers to a diameter at the distal end of the guidewire that is smaller than the diameter of a major
portion of the core.
9. The magnetic guidewire of Claim 2, wherein the polymer sheath extends continuously from a location near the proximal end of the guidewire, to a location distal of the transition point, thus surrounding at least a portion of both the glass core and the metal distal tip segment.
10. The magnetic guidewire of Claim 1, further comprising a short metal collar affixed to the guidewire at the transition point, to resist kinking and breakage of the guidewire at the transition point.
11. The magnetic guidewire of Claim 1, wherein the material of the marker is Dysprosium Oxide (Dy2O3).
12. The magnetic guidewire of Claim 1, wherein the distal tip of the guidewire is bent
slightly, to facilitate the selective steering of the guidewire along a desired vascular path.
EP98926103A 1997-06-06 1998-05-28 Glass core guidewire compatible with magnetic resonance having reinforcing fibers Withdrawn EP0989820A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
NL1006254 1997-06-06
NL1006254A NL1006254C2 (en) 1997-06-06 1997-06-06 MRI-compatible guidewire.
PCT/US1998/010864 WO1998055016A1 (en) 1997-06-06 1998-05-28 Glass core guidewire compatible with magnetic resonance having reinforcing fibers

Publications (2)

Publication Number Publication Date
EP0989820A1 EP0989820A1 (en) 2000-04-05
EP0989820A4 true EP0989820A4 (en) 2001-01-24

Family

ID=19765120

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98926103A Withdrawn EP0989820A4 (en) 1997-06-06 1998-05-28 Glass core guidewire compatible with magnetic resonance having reinforcing fibers

Country Status (4)

Country Link
EP (1) EP0989820A4 (en)
AU (1) AU7801798A (en)
NL (1) NL1006254C2 (en)
WO (1) WO1998055016A1 (en)

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Also Published As

Publication number Publication date
EP0989820A1 (en) 2000-04-05
AU7801798A (en) 1998-12-21
WO1998055016A1 (en) 1998-12-10
NL1006254C2 (en) 1998-12-08

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